e424b3
Filed pursuant to
Rule 424(b)(3)
Registration No. 333-152442
SPECIAL
MEETING OF STOCKHOLDERS
MERGER PROPOSED YOUR VOTE IS VERY
IMPORTANT
To the Stockholders of Critical Therapeutics, Inc.:
On May 1, 2008, Critical Therapeutics, Inc., which we refer
to as Critical Therapeutics, and Cornerstone BioPharma Holdings,
Inc., which we refer to as Cornerstone, entered into a merger
agreement pursuant to which Neptune Acquisition Corp., a wholly
owned subsidiary of Critical Therapeutics, which we refer to as
the transitory subsidiary, will merge with and into Cornerstone,
with Cornerstone continuing after the merger as the surviving
company and a wholly owned subsidiary of Critical Therapeutics.
At the effective time of the merger, all outstanding shares of
Cornerstones common stock will be converted into and
exchanged for shares of Critical Therapeutics common stock
and all outstanding options, whether vested or unvested, and all
outstanding warrants to purchase Cornerstones common stock
will be assumed by Critical Therapeutics and become options and
warrants to purchase Critical Therapeutics common stock.
Pursuant to the merger, Critical Therapeutics will issue to
Cornerstones stockholders, and will assume Cornerstone
options and warrants that will represent, an aggregate of
approximately 101.5 million shares of Critical
Therapeutics common stock, subject to adjustment as a
result of a reverse stock split of Critical Therapeutics
common stock to occur in connection with the merger. Immediately
following the effective time of the merger, Cornerstones
stockholders will own approximately 70%, and Critical
Therapeutics current stockholders will own approximately
30%, of Critical Therapeutics common stock, assuming the
exchange or conversion prior to the merger of the outstanding
principal amount of a note issued by a wholly owned subsidiary
of Cornerstone into shares of Cornerstones common stock
and after giving effect to shares issuable pursuant to
Cornerstones outstanding options and warrants, but without
giving effect to any shares issuable pursuant to Critical
Therapeutics outstanding options and warrants. The exact
exchange ratio per share of Cornerstones common stock will
be based in part on the number of shares of Cornerstones
common stock outstanding or issuable pursuant to outstanding
options and warrants immediately prior to the effective time of
the merger and will not be calculated until that time.
Shares of Critical Therapeutics common stock are currently
listed on The NASDAQ Capital Market under the symbol
CRTX. After completion of the merger, Critical
Therapeutics will be renamed Cornerstone Therapeutics
Inc. and expects to continue to trade under the symbol
CRTX on The NASDAQ Capital Market in connection with
the listing of Critical Therapeutics common stock pursuant
to NASDAQ Marketplace Rule 4340. Following the merger,
Critical Therapeutics will appoint new directors and executive
officers designated by Cornerstone, and the headquarters of
Critical Therapeutics will be located in Cary, North Carolina,
at Cornerstones headquarters. On September 29, 2008,
the last practicable date before the printing of this proxy
statement/prospectus, the closing price per share of Critical
Therapeutics common stock as reported on The NASDAQ
Capital Market was $0.17.
Critical Therapeutics is holding a special meeting of
stockholders in order to obtain the stockholder approvals
necessary to complete the merger. At the special meeting, which
will be held at 10:00 a.m., local time, on October 31,
2008, at the offices of Wilmer Cutler Pickering Hale and Dorr
LLP, located at 60 State Street, Boston, Massachusetts 02109,
unless postponed or adjourned to a later date, Critical
Therapeutics will ask its stockholders to approve the issuance
of Critical Therapeutics common stock pursuant to the
merger agreement, approve an amendment to Critical
Therapeutics certificate of incorporation to effect a
reverse stock split of Critical Therapeutics common stock,
as described below, referred to as the reverse stock split, and
approve an amendment to Critical Therapeutics certificate
of incorporation to change the name of Critical Therapeutics to
Cornerstone Therapeutics Inc. Upon the effectiveness
of the amendment to Critical Therapeutics certificate of
incorporation effecting the reverse stock split, the outstanding
shares of Critical Therapeutics common stock will be
reclassified and combined into a lesser number of shares to be
determined by Critical Therapeutics board of directors
prior to the effective time of such amendment and publicly
announced by Critical Therapeutics.
After careful consideration, Critical Therapeutics board
of directors has unanimously approved the merger agreement and
the proposals referred to above, and has determined that they
are advisable, fair to and in the best interests of Critical
Therapeutics stockholders. Accordingly, Critical
Therapeutics board of directors unanimously recommends
that stockholders vote FOR the issuance of Critical
Therapeutics common stock pursuant to the merger
agreement, FOR the amendment to Critical Therapeutics
certificate of incorporation to effect the reverse stock split
and FOR the amendment to Critical Therapeutics
certificate of incorporation to change the name of Critical
Therapeutics to Cornerstone Therapeutics Inc.
More information about Critical Therapeutics, Cornerstone and
the proposed transaction is contained in the accompanying proxy
statement/prospectus. Critical Therapeutics urges you to read
the proxy statement/prospectus carefully and in its entirety. IN
PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED
UNDER RISK FACTORS BEGINNING ON PAGE 24.
Your vote is important. Whether or not you expect to
attend the special meeting in person, please complete, date,
sign and promptly return the accompanying proxy card in the
enclosed postage paid envelope to ensure that your shares will
be represented and voted at the special meeting.
Critical Therapeutics is excited about the opportunities the
merger brings to its stockholders, and we thank you for your
consideration and continued support.
Yours sincerely,
Trevor Phillips, Ph.D.
President and Chief Executive Officer
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved the merger
described in this proxy statement/prospectus or the Critical
Therapeutics common stock to be issued in connection with
the merger or determined if this proxy statement/prospectus is
accurate or adequate. Any representation to the contrary is a
criminal offense.
This proxy statement/prospectus is dated October 3, 2008,
and is first being mailed to stockholders on or about
October 6, 2008.
CRITICAL
THERAPEUTICS, INC.
60 WESTVIEW STREET
LEXINGTON, MASSACHUSETTS 02421
NOTICE OF SPECIAL MEETING OF
STOCKHOLDERS
To Be Held On October 31,
2008
To the Stockholders of Critical Therapeutics, Inc.:
A special meeting of stockholders of Critical Therapeutics, Inc.
will be held at 10:00 a.m., local time, on October 31,
2008, at the offices of Wilmer Cutler Pickering Hale and Dorr
LLP, located at 60 State Street, Boston, Massachusetts 02109, to
consider and act upon the following matters:
|
|
|
|
1.
|
To approve the issuance of Critical Therapeutics common
stock pursuant to the Agreement and Plan of Merger, dated as of
May 1, 2008, by and among Critical Therapeutics, Neptune
Acquisition Corp., a wholly owned subsidiary of Critical
Therapeutics, and Cornerstone BioPharma Holdings, Inc.
|
|
|
2.
|
To approve an amendment to Critical Therapeutics
certificate of incorporation to effect a reverse stock split of
Critical Therapeutics common stock.
|
|
|
3.
|
To approve an amendment to Critical Therapeutics
certificate of incorporation to change the name of Critical
Therapeutics to Cornerstone Therapeutics Inc.
|
|
|
4.
|
To consider and vote upon an adjournment of the special meeting,
if necessary, if a quorum is present, to solicit additional
proxies if there are not sufficient votes in favor of
Proposals 1, 2 and 3.
|
Stockholders also will consider and act on any other matters as
may properly come before the special meeting or any adjournment
or postponement thereof, including any procedural matters
incident to the conduct of the special meeting.
September 29, 2008 is the record date for the determination
of stockholders entitled to notice of, and to vote at, the
special meeting and any adjournment or postponement thereof.
Only holders of record of shares of Critical Therapeutics
common stock at the close of business on the record date are
entitled to notice of, and to vote at, the special meeting. At
the close of business on the record date, Critical Therapeutics
had 43,332,598 shares of common stock outstanding and
entitled to vote at the special meeting.
Your vote is important. The affirmative vote of the holders
of a majority of the shares of Critical Therapeutics
common stock present in person or represented by proxy and
voting on such matter at the special meeting is required for
approval of Proposal 1 and Proposal 4 above. The
affirmative vote of holders of a majority of the outstanding
shares of Critical Therapeutics common stock as of the
record date for the special meeting is required for approval of
Proposal 2 and Proposal 3 above.
Whether or not you plan to attend the special meeting in
person, please complete, date, sign and promptly return the
accompanying proxy card in the enclosed postage paid envelope to
ensure that your shares will be represented and voted at the
special meeting. If you date, sign and return your proxy card
without indicating how you wish to vote, your proxy will be
counted as a vote in favor of Proposals 1 through 4. If you
fail either to return your proxy card or vote in person at the
special meeting, your shares will not be counted for purposes of
determining whether a quorum is present at the special
meeting and will have the same effect as a vote against
Proposal 2 and Proposal 3. If you attend the special
meeting, you may, upon your written request, withdraw your proxy
and vote in person.
By Order of the Board of Directors of
Critical Therapeutics, Inc.
Scott B. Townsend, Esq.
Secretary
October 3, 2008
Lexington, Massachusetts
CRITICAL THERAPEUTICS BOARD OF DIRECTORS HAS DETERMINED
AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS
ADVISABLE, FAIR TO AND IN THE BEST INTERESTS OF CRITICAL
THERAPEUTICS AND ITS STOCKHOLDERS AND HAS UNANIMOUSLY APPROVED
EACH SUCH PROPOSAL. CRITICAL THERAPEUTICS BOARD OF
DIRECTORS UNANIMOUSLY RECOMMENDS THAT CRITICAL
THERAPEUTICS STOCKHOLDERS VOTE FOR EACH SUCH
PROPOSAL.
REFERENCES
TO ADDITIONAL INFORMATION
This proxy statement/prospectus forms a part of a registration
statement on
Form S-4
(Registration
No. 333-152442)
filed by Critical Therapeutics, Inc., or Critical Therapeutics,
with the U.S. Securities and Exchange Commission, or SEC.
It constitutes a prospectus of Critical Therapeutics under
Section 5 of the Securities Act of 1933, as amended, or the
Securities Act, and the rules thereunder, with respect to the
shares of Critical Therapeutics common stock to be issued
to holders of common stock of Cornerstone BioPharma Holdings,
Inc., or Cornerstone, in the merger. In addition, it constitutes
a proxy statement under Section 14(a) of the Securities
Exchange Act of 1934, as amended, or the Exchange Act, and the
rules thereunder, and a notice of meeting with respect to the
special meeting of stockholders at which Critical
Therapeutics stockholders will consider and vote on the
proposals to approve the issuance of Critical Therapeutics
common stock issuable to the holders of Cornerstones
common stock pursuant to the merger agreement described in this
proxy statement/prospectus, an amendment to Critical
Therapeutics certificate of incorporation to effect a
reverse stock split of Critical Therapeutics common stock
and an amendment to Critical Therapeutics certificate of
incorporation to change the name of Critical Therapeutics to
Cornerstone Therapeutics Inc.
This proxy statement/prospectus incorporates important business
and financial information about Critical Therapeutics that is
not included in or delivered with this proxy
statement/prospectus. This information is available to you
without charge upon your written or oral request. You can obtain
these documents, which are incorporated by reference in this
proxy statement/prospectus, by requesting them in writing or by
telephone at the following address and telephone number:
CRITICAL THERAPEUTICS, INC.
Thomas P. Kelly
Chief Financial Officer
60 Westview Street
Lexington, Massachusetts 02421
Tel:
(781) 402-5700
IF YOU WOULD LIKE TO REQUEST DOCUMENTS, PLEASE DO SO BY
OCTOBER 17, 2008 IN ORDER TO RECEIVE THEM BEFORE THE SPECIAL
MEETING.
See Where You Can Find More Information beginning on
page 352.
NOTE REGARDING
TRADEMARKS
Zyflo®
and Zyflo
CR®
are registered trademarks of Critical Therapeutics.
Cornerstone BioPharma,
Inc.®,
AlleRx®,
Balacet®
and
Deconsal®
are registered trademarks, and Aristos
Pharmaceuticalstm,
Cornerstone Therapeutics
Inc.tm,
HyoMaxtm
and
RespiVenttm
are trademarks, of Cornerstone.
Spectracef®
is a registered trademark of Meiji Seika Kaisha, Ltd.
The other trademarks, trade names and service marks appearing in
this proxy statement/prospectus are the property of their
respective holders.
TABLE OF
CONTENTS
|
|
|
|
|
|
|
|
v
|
|
|
|
|
1
|
|
|
|
|
1
|
|
|
|
|
3
|
|
|
|
|
3
|
|
|
|
|
3
|
|
|
|
|
4
|
|
|
|
|
6
|
|
|
|
|
7
|
|
|
|
|
7
|
|
|
|
|
7
|
|
|
|
|
9
|
|
|
|
|
10
|
|
|
|
|
11
|
|
|
|
|
11
|
|
|
|
|
12
|
|
|
|
|
12
|
|
|
|
|
12
|
|
|
|
|
12
|
|
|
|
|
12
|
|
|
|
|
13
|
|
|
|
|
14
|
|
|
|
|
16
|
|
|
|
|
18
|
|
|
|
|
20
|
|
|
|
|
22
|
|
|
|
|
24
|
|
|
|
|
24
|
|
|
|
|
28
|
|
|
|
|
59
|
|
|
|
|
86
|
|
|
|
|
91
|
|
|
|
|
92
|
|
|
|
|
92
|
|
|
|
|
92
|
|
|
|
|
92
|
|
|
|
|
93
|
|
|
|
|
93
|
|
|
|
|
94
|
|
|
|
|
95
|
|
|
|
|
95
|
|
|
|
|
96
|
|
|
|
|
96
|
|
|
|
|
|
|
|
|
|
106
|
|
|
|
|
108
|
|
|
|
|
113
|
|
|
|
|
119
|
|
|
|
|
125
|
|
|
|
|
128
|
|
|
|
|
129
|
|
|
|
|
129
|
|
|
|
|
130
|
|
|
|
|
130
|
|
|
|
|
130
|
|
|
|
|
133
|
|
|
|
|
134
|
|
|
|
|
134
|
|
|
|
|
137
|
|
|
|
|
137
|
|
|
|
|
137
|
|
|
|
|
137
|
|
|
|
|
138
|
|
|
|
|
140
|
|
|
|
|
141
|
|
|
|
|
141
|
|
|
|
|
142
|
|
|
|
|
146
|
|
|
|
|
147
|
|
|
|
|
148
|
|
|
|
|
149
|
|
|
|
|
150
|
|
|
|
|
150
|
|
|
|
|
151
|
|
|
|
|
151
|
|
|
|
|
151
|
|
|
|
|
151
|
|
|
|
|
152
|
|
|
|
|
152
|
|
|
|
|
152
|
|
|
|
|
159
|
|
|
|
|
159
|
|
|
|
|
161
|
|
|
|
|
161
|
|
|
|
|
162
|
|
|
|
|
162
|
|
|
|
|
162
|
|
|
|
|
168
|
|
ii
|
|
|
|
|
|
|
|
170
|
|
|
|
|
173
|
|
|
|
|
173
|
|
|
|
|
174
|
|
|
|
|
177
|
|
|
|
|
178
|
|
|
|
|
182
|
|
|
|
|
183
|
|
|
|
|
187
|
|
|
|
|
188
|
|
|
|
|
189
|
|
|
|
|
189
|
|
|
|
|
189
|
|
|
|
|
190
|
|
|
|
|
190
|
|
|
|
|
191
|
|
|
|
|
192
|
|
|
|
|
196
|
|
|
|
|
199
|
|
|
|
|
203
|
|
|
|
|
205
|
|
|
|
|
206
|
|
|
|
|
209
|
|
|
|
|
211
|
|
|
|
|
221
|
|
|
|
|
222
|
|
|
|
|
230
|
|
|
|
|
231
|
|
|
|
|
232
|
|
|
|
|
232
|
|
|
|
|
232
|
|
|
|
|
232
|
|
|
|
|
235
|
|
|
|
|
235
|
|
|
|
|
236
|
|
|
|
|
240
|
|
|
|
|
246
|
|
|
|
|
259
|
|
|
|
|
263
|
|
|
|
|
264
|
|
|
|
|
266
|
|
|
|
|
267
|
|
|
|
|
267
|
|
iii
|
|
|
|
|
|
|
|
270
|
|
|
|
|
275
|
|
|
|
|
279
|
|
|
|
|
285
|
|
|
|
|
291
|
|
|
|
|
291
|
|
|
|
|
291
|
|
|
|
|
293
|
|
|
|
|
294
|
|
|
|
|
294
|
|
|
|
|
297
|
|
|
|
|
298
|
|
|
|
|
300
|
|
|
|
|
326
|
|
|
|
|
327
|
|
|
|
|
336
|
|
|
|
|
336
|
|
|
|
|
336
|
|
|
|
|
337
|
|
|
|
|
337
|
|
|
|
|
339
|
|
|
|
|
344
|
|
|
|
|
347
|
|
|
|
|
349
|
|
|
|
|
352
|
|
|
|
|
352
|
|
|
|
|
352
|
|
|
|
|
F-1
|
|
|
|
|
F-52
|
|
|
|
|
|
|
ANNEXES
|
|
|
|
A-1
|
|
|
|
|
B-1
|
|
|
|
|
C-1
|
|
|
|
|
D-1
|
|
|
|
|
E-1
|
|
iv
QUESTIONS
AND ANSWERS ABOUT THE SPECIAL MEETING AND THE MERGER
Except as specifically indicated, the following information and
all other information contained in this proxy
statement/prospectus does not give effect to the reverse stock
split described in Proposal 2.
The following section provides answers to frequently asked
questions about the special meeting of stockholders and the
merger. This section, however, only provides summary
information. These questions and answers may not address all
issues that may be important to you as a stockholder. For a more
complete response to these questions and for additional
information, please refer to the cross-referenced pages below.
You should carefully read this entire proxy
statement/prospectus, including each of the annexes.
|
|
|
Q: |
|
What is the merger? |
|
A: |
|
Critical Therapeutics and Cornerstone have entered into an
Agreement and Plan of Merger, dated as of May 1, 2008, or
the merger agreement, that contains the terms and conditions of
the proposed business combination of Critical Therapeutics and
Cornerstone. Under the merger agreement, Cornerstone and Neptune
Acquisition Corp., a wholly owned subsidiary of Critical
Therapeutics, or the transitory subsidiary, will merge, with
Cornerstone surviving as a wholly owned subsidiary of Critical
Therapeutics. This transaction is referred to as the merger. |
|
Q: |
|
How many shares of Critical Therapeutics common stock
will be issued or become issuable pursuant to the merger? |
|
A: |
|
Pursuant to the merger, Critical Therapeutics will issue to
Cornerstones stockholders, and will assume Cornerstone
options and warrants that will represent, an aggregate of
approximately 101.5 million shares of Critical
Therapeutics common stock, subject to adjustment as a
result of a reverse stock split of Critical Therapeutics
common stock to occur in connection with the merger. |
|
Q: |
|
What percentage of Critical Therapeutics common stock
will this represent? |
|
A: |
|
Immediately following the effective time of the merger,
Cornerstones stockholders will own approximately 70%, and
Critical Therapeutics current stockholders will own
approximately 30%, of Critical Therapeutics common stock,
assuming the exchange or conversion prior to the merger of the
outstanding principal amount of a note issued by a wholly owned
subsidiary of Cornerstone into shares of Cornerstones
common stock and after giving effect to shares issuable pursuant
to Cornerstones outstanding options and warrants, but
without giving effect to any shares issuable pursuant to
Critical Therapeutics outstanding options and warrants. |
|
Q: |
|
What is the reverse stock split and why is it necessary? |
|
A: |
|
Immediately prior to the effective time of the merger, the
outstanding shares of Critical Therapeutics common stock
will be reclassified and combined into a lesser number of shares
to be determined by Critical Therapeutics board of
directors prior to the effective time and publicly announced by
Critical Therapeutics. Because The NASDAQ Capital Markets
initial listing standards require Critical Therapeutics to have,
among other things, a $4.00 per share minimum bid price, the
reverse stock split is necessary to consummate the merger. |
|
Q: |
|
What will happen to Critical Therapeutics if, for any reason,
the merger with Cornerstone does not close? |
|
A: |
|
Critical Therapeutics has invested significant time and
incurred, and expects to continue to incur, significant expenses
related to the proposed merger with Cornerstone. In the event
the merger does not close, Critical Therapeutics will have a
limited ability to continue its current operations without
obtaining additional financing. Although Critical
Therapeutics board of directors may elect to, among other
things, attempt to complete another strategic transaction if the
merger with Cornerstone does not close, Critical
Therapeutics board of directors may instead divest all or
a portion of Critical Therapeutics business or take steps
necessary to liquidate or dissolve Critical Therapeutics
business and assets if a viable alternative strategic
transaction is not available. |
v
|
|
|
Q: |
|
Why am I receiving this proxy statement/prospectus? |
|
A: |
|
You are receiving this proxy statement/prospectus because you
have been identified as a stockholder of Critical Therapeutics
as of the record date, and thus you are entitled to vote at
Critical Therapeutics special meeting. This document
serves as both a proxy statement used to solicit proxies for the
special meeting and as a prospectus used to offer shares of
Critical Therapeutics common stock in exchange for shares
of Cornerstones common stock pursuant to the terms of the
merger agreement. This document contains important information
about the merger and the special meeting of Critical
Therapeutics, and you should read it carefully. |
|
Q: |
|
Who is soliciting my proxy? |
|
A: |
|
This proxy is being solicited by Critical Therapeutics
board of directors. |
|
Q: |
|
What stockholder approvals are required to consummate the
merger? |
|
A: |
|
To consummate the merger, Critical Therapeutics
stockholders must approve: |
|
|
|
|
|
the issuance of shares of Critical Therapeutics common
stock in the merger, which requires the affirmative vote of the
holders of a majority of the shares of Critical
Therapeutics common stock present in person or represented
by proxy and voting on such matter at the special meeting;
|
|
|
|
the amendment to Critical Therapeutics certificate of
incorporation to effect the reverse stock split of Critical
Therapeutics common stock, which requires the affirmative
vote of holders of a majority of the outstanding shares of
Critical Therapeutics common stock as of the record date
for the special meeting; and
|
|
|
|
the amendment to Critical Therapeutics certificate of
incorporation to change the name of Critical Therapeutics to
Cornerstone Therapeutics Inc., which requires the
affirmative vote of the holders of a majority of the outstanding
shares of Critical Therapeutics common stock as of the
record date for the special meeting.
|
|
|
|
|
|
In addition, Cornerstones stockholders must adopt the
merger agreement, which requires the affirmative vote of holders
of a majority of the outstanding shares of Cornerstones
common stock. On May 2, 2008, holders of a majority of
Cornerstones outstanding shares of common stock adopted
the merger agreement pursuant to written consents in lieu of a
meeting. |
|
Q: |
|
How does Critical Therapeutics board of directors
recommend that Critical Therapeutics stockholders vote? |
|
A: |
|
After careful consideration, Critical Therapeutics board
of directors has unanimously approved the merger agreement and
each of the proposals described in this proxy
statement/prospectus that the stockholders of Critical
Therapeutics are being asked to consider, and has determined
that they are advisable, fair to and in the best interests of
Critical Therapeutics stockholders. Accordingly, Critical
Therapeutics board of directors unanimously recommends
that Critical Therapeutics stockholders vote FOR each such
proposal. |
|
Q: |
|
How did Cornerstones board of directors recommend that
Cornerstones stockholders vote? |
|
A: |
|
After careful consideration, Cornerstones board of
directors unanimously recommended that Cornerstones
stockholders vote to adopt the merger agreement. |
|
Q: |
|
When do you expect the merger to be consummated? |
|
A: |
|
Critical Therapeutics and Cornerstone anticipate that the
consummation of the merger will occur as promptly as practicable
after the special meeting and following satisfaction or waiver
of all closing conditions. However, the exact timing of the
consummation of the merger is not yet known. |
vi
|
|
|
Q: |
|
What do I need to do now? |
|
A: |
|
You are urged to read this proxy statement/prospectus carefully,
including each of the annexes, and to consider how the merger
affects you. If your shares are registered directly in your
name, you may vote in one of four different ways. First, you can
provide your proxy instructions over the Internet at the web
site of Critical Therapeutics tabulator, BNY Mellon
Shareowner Services, at
http://www.proxyvoting.com/crtx,
by following the instructions you will find there. Second, you
can provide your proxy instructions by telephone at
(866) 540-5760
toll-free from the United States or Canada, by following the
instructions. Third, you can complete, date and sign the
enclosed proxy card and mail it in the enclosed postage-paid
envelope to BNY Mellon Shareowner Services. Alternatively, you
can deliver your completed proxy card in person or vote by
completing a ballot in person at the special meeting. |
|
Q: |
|
What happens if I do not return a proxy card or otherwise
provide proxy instructions? |
|
A: |
|
The failure to return your proxy card or otherwise provide proxy
instructions will have the same effect as voting against
Proposal 2 and Proposal 3, and your shares will not be
counted for purposes of determining whether a quorum is present
at the special meeting. |
|
Q: |
|
May I vote in person? |
|
A: |
|
If you are a stockholder of Critical Therapeutics and your
shares of Critical Therapeutics common stock are
registered directly in your name with Critical
Therapeutics transfer agent, you are considered, with
respect to those shares, the stockholder of record, and the
proxy materials and proxy card are being sent directly to you by
Critical Therapeutics. If you are a Critical Therapeutics
stockholder of record, you may attend the special meeting to be
held on October 31, 2008 and vote your shares in person,
rather than signing and returning your proxy. |
|
|
|
If your shares of Critical Therapeutics common stock are
held by a bank, broker or other nominee, you are considered the
beneficial owner of shares held in street name, and
the proxy materials are being forwarded to you together with a
voting instruction card. As the beneficial owner, you are also
invited to attend the special meeting. Since a beneficial owner
is not the stockholder of record, you may not vote these shares
in person at the special meeting unless you obtain a proxy from
your broker issued in your name giving you the right to vote the
shares at the special meeting. |
|
Q: |
|
If my Critical Therapeutics shares are held in street
name by my broker, will my broker vote my shares for
me? |
|
A: |
|
Your broker will not be able to vote your shares of Critical
Therapeutics common stock without specific instructions
from you. You should instruct your broker to vote your shares,
following the procedure provided by your broker. |
|
Q: |
|
May I change my vote after I have submitted a proxy or
provided proxy instructions? |
|
A: |
|
Any Critical Therapeutics stockholder of record voting by
proxy, other than those Critical Therapeutics stockholders
who have executed a voting agreement and irrevocable proxy, has
the right to revoke the proxy at any time before the polls close
at the special meeting by sending a written notice stating that
it would like to revoke its proxy to the Secretary of Critical
Therapeutics, by voting again over the Internet or by telephone,
by providing a duly executed proxy card bearing a later date
than the proxy being revoked or by attending the special meeting
and voting in person. Attendance alone at the special meeting
will not revoke a proxy. If a stockholder of Critical
Therapeutics has instructed a broker to vote its shares of
Critical Therapeutics common stock that are held in
street name, the stockholder must follow directions
received from its broker to change those instructions. |
|
Q: |
|
Should Cornerstones and Critical Therapeutics
stockholders send in their stock certificates now? |
|
A: |
|
No. After the merger is consummated, Cornerstones
stockholders will receive written instructions from the exchange
agent for exchanging their certificates representing shares of
Cornerstone capital stock for certificates representing shares
of Critical Therapeutics common stock. Cornerstones
stockholders will also receive a cash payment for any fractional
shares. |
vii
|
|
|
|
|
In addition, Critical Therapeutics stockholders will
receive written instructions, as applicable, from Critical
Therapeutics transfer agent for exchanging their
certificates representing shares of Critical Therapeutics
common stock for new certificates giving effect to the reverse
stock split. Critical Therapeutics stockholders will also
receive a cash payment for any fractional shares. |
|
Q: |
|
Who is paying for this proxy solicitation? |
|
A: |
|
Critical Therapeutics will bear the cost of soliciting proxies,
including the printing, mailing and filing of this proxy
statement/prospectus, the proxy card and any additional
information furnished to Critical Therapeutics
stockholders. Critical Therapeutics has engaged
Morrow & Co., LLC, a proxy solicitation firm, to
solicit proxies from Critical Therapeutics stockholders.
Arrangements will also be made with banks, brokers, nominees,
custodians and fiduciaries who are record holders of Critical
Therapeutics common stock for the forwarding of
solicitation materials to the beneficial owners of Critical
Therapeutics common stock. Critical Therapeutics will
reimburse these banks, brokers, nominees, custodians and
fiduciaries for the reasonable out-of-pocket expenses they incur
in connection with the forwarding of solicitation materials. |
|
Q: |
|
Who can provide me with additional information and help
answer my questions? |
|
A: |
|
If you would like additional copies, without charge, of this
proxy statement/prospectus or if you have questions about the
merger and the other proposals being considered at the special
meeting, including the procedures for voting your shares, you
should contact Morrow & Co., LLC, Critical
Therapeutics proxy solicitor, by telephone at
1-800-607-0088
or by email at crtx.info@morrowco.com. |
viii
SUMMARY
This summary highlights selected information from this proxy
statement/prospectus and may not contain all of the information
that is important to you. To better understand the merger and
the other proposals being considered at the special meeting, you
should read this entire proxy statement/prospectus carefully,
including the materials attached as annexes, as well as other
documents referred to or incorporated by reference herein. See
Where You Can Find More Information beginning on
page 352 of this proxy statement/prospectus. Page
references are included in parentheses to direct you to a more
detailed description of the topics presented in this summary.
The
Companies
Critical Therapeutics, Inc.
60 Westview Street
Lexington, Massachusetts 02421
(781) 402-5700
Critical Therapeutics is a biopharmaceutical company focused on
developing and commercializing products for respiratory and
inflammatory diseases. Critical Therapeutics owns worldwide
rights to two marketed products: ZYFLO
CR®
(zileuton) extended-release tablets, or ZYFLO CR, which the U.S.
Food and Drug Administration, or FDA, approved in May 2007,
and
ZYFLO®
(zileuton tablets), or ZYFLO, which the FDA approved in 1996,
for the prevention and chronic treatment of asthma in adults
12 years of age or older. Critical Therapeutics also is
developing an injectable formulation of zileuton, or zileuton
injection, for use in the hospital emergency department for the
treatment of acute asthma attacks. In June 2008, Critical
Therapeutics announced the results from its Phase II
clinical trial with zileuton injection in patients with chronic,
stable asthma. In addition, Critical Therapeutics is developing
other product candidates directed toward the bodys
inflammatory response. Critical Therapeutics has conducted
preclinical work in its alpha-7 nicotinic acetylcholine receptor
program, or alpha-7 program, for the treatment of severe acute
inflammatory disease. Critical Therapeutics also has
collaboration agreements with third parties for the development
of monoclonal antibodies directed toward a cytokine called high
mobility group box protein 1, or HMGB1, and a diagnostic
directed toward measuring HMGB1 in the bloodstream. Both of
these programs are in preclinical stages of development.
Cornerstone BioPharma Holdings, Inc.
2000 Regency Parkway, Suite 255
Cary, North Carolina 27518
(888) 466-6505
Cornerstone is a specialty pharmaceutical company focused on
acquiring, developing and commercializing prescription products
for the respiratory market. Cornerstone currently promotes four
marketed products in the United States to respiratory-focused
physicians and key retail pharmacies with its approximately
50 person specialty sales force. Cornerstone also generates
revenue from the sale of seven marketed product lines that
include products that it does not promote.
Some of Cornerstones marketed products are approved by the
FDA while others are marketed in the United States without an
FDA-approved marketing application because they have been
considered by Cornerstone to be identical, related or similar to
products that have existed in the market without an FDA-approved
marketing application, and which were thought not to require
pre-market review and approval, or which were approved only on
the basis of safety, at the time they entered the marketplace,
subject to FDA enforcement policies established in connection
with the FDAs Drug Efficacy Study Implementation, or DESI,
program. For a more complete discussion regarding FDA drug
approval requirements, please see the section entitled
Risks Related to Cornerstone Some of
Cornerstones specialty pharmaceutical products are now
being marketed without approved NDAs or ANDAs beginning on
page 70 of this proxy statement/prospectus and the section
entitled Cornerstones Business
Regulatory Matters beginning on page 222 of this
proxy statement/prospectus.
1
Cornerstone derives revenues from the following products as of
September 15, 2008:
|
|
|
|
|
|
|
|
|
|
|
Promoted by
|
|
Approved by
|
Product
|
|
Cornerstone
|
|
FDA
|
|
ALLERX 10 Dose Pack and ALLERX 30 Dose Pack
|
|
|
Yes
|
|
|
|
No
|
|
ALLERX Dose Pack DF and ALLERX Dose Pack DF 30
|
|
|
Yes
|
|
|
|
No
|
|
ALLERX Dose Pack PE and ALLERX Dose Pack PE 30
|
|
|
Yes
|
|
|
|
No
|
|
ALLERX Suspension
|
|
|
No
|
|
|
|
No
|
|
ALLERX-D
|
|
|
No
|
|
|
|
No
|
|
APAP 325
|
|
|
No
|
|
|
|
Yes
|
|
APAP 500
|
|
|
No
|
|
|
|
Yes
|
|
BALACET 325
|
|
|
No
|
|
|
|
Yes
|
|
DECONSAL CT
|
|
|
No
|
|
|
|
No
|
|
DECONSAL DM
|
|
|
No
|
|
|
|
No
|
|
Extendryl
|
|
|
No
|
|
|
|
No
|
|
HYOMAX DT
|
|
|
No
|
|
|
|
No
|
|
HYOMAX FT
|
|
|
No
|
|
|
|
No
|
|
HYOMAX SL
|
|
|
No
|
|
|
|
No
|
|
HYOMAX SR
|
|
|
No
|
|
|
|
No
|
|
RESPIVENT DF Dose Pack
|
|
|
No
|
|
|
|
No
|
|
RESPIVENT-D
|
|
|
No
|
|
|
|
No
|
|
SPECTRACEF
|
|
|
Yes
|
|
|
|
Yes
|
|
Cornerstones commercial strategy is to acquire
non-promoted or underperforming branded pharmaceutical products
and then maximize their potential value by promoting the
products using its sales and marketing capabilities and applying
various product life cycle management techniques.
Cornerstones product development pipeline consists of
three line extensions of SPECTRACEF and three other product
candidates for the respiratory market, which consist of the
following:
|
|
|
|
|
|
|
Product Candidate
|
|
Regulatory Status
|
|
Therapeutic Class
|
|
Development Stage
|
|
Spectracef Line Extensions
|
|
|
|
|
|
|
SPECTRACEF 400 mg
|
|
sNDA approved in July 2008
|
|
Antibiotic
|
|
Product launch targeted for fourth quarter of 2008
|
SPECTRACEF Once Daily
|
|
NDA submission targeted in 2010
|
|
Antibiotic
|
|
Phase I clinical trial targeted to begin in the fourth
quarter of 2008
|
SPECTRACEF Suspension
|
|
NDA submission for pharyngitis or tonsillitis targeted in 2009;
sNDA submission for acute otitis media targeted in 2010
|
|
Antibiotic
|
|
Phase III clinical trials completed for pharyngitis or
tonsillitis indication; Phase III clinical trials for acute
otitis media targeted to begin in 2009
|
Other Product Candidates
|
|
|
|
|
|
|
CBP 058
|
|
NDA submission targeted in 2010
|
|
Antihistamine and anticholinergic combination
|
|
Phase I clinical trial targeted to begin in the first
quarter of 2009
|
CBP 067
|
|
Regulatory submission targeted in 2009
|
|
Antihistamine and antitussive combination
|
|
Phase I clinical trial targeted to begin in 2009
|
CBP 069
|
|
Regulatory submission targeted in 2009
|
|
Antihistamine and antitussive combination
|
|
Phase I clinical trial targeted to begin in 2009
|
2
Summary
of the Merger (see page 96)
If the merger is consummated, Cornerstone and the transitory
subsidiary, a wholly owned subsidiary of Critical Therapeutics,
will merge, with Cornerstone surviving as a wholly owned
subsidiary of Critical Therapeutics. A copy of the merger
agreement is attached as Annex A to this proxy
statement/prospectus. You are encouraged to read the merger
agreement in its entirety because it is the legal document that
governs the merger.
Reasons
for the Merger (see page 108)
Critical Therapeutics and Cornerstone believe that the combined
company resulting from the merger will have the following
potential advantages:
|
|
|
|
|
The combined company will be a larger respiratory-focused
specialty pharmaceutical company with multiple marketed
products, a more balanced revenue stream and important product
development opportunities.
|
|
|
|
The combined company is expected to focus its resources on
developing a successful specialty pharmaceutical business
without the additional challenge of trying to simultaneously
build an early-stage drug development pipeline.
|
|
|
|
There are significant potential synergies and cost savings that
Critical Therapeutics and Cornerstone believe can be achieved by
consolidating the infrastructures of the two companies and
allowing management to fully leverage the combined sales force
across multiple revenue generating products.
|
Each of the boards of directors of Critical Therapeutics and
Cornerstone also considered other reasons for the merger, as
described herein.
Critical Therapeutics board of directors considered, among
other things:
|
|
|
|
|
Critical Therapeutics limited prospects if it were to
remain an independent, standalone company;
|
|
|
|
the opportunity for Critical Therapeutics stockholders to
participate in the potential future value of the combined
company; and
|
|
|
|
its view as to the potential for other third parties to enter
into strategic relationships with or acquire Critical
Therapeutics on favorable terms, if at all, based on the lack of
interest expressed by third parties during the strategic
alternatives review process undertaken by Critical Therapeutics.
|
Cornerstones board of directors considered, among other
things:
|
|
|
|
|
the opportunity to expand Cornerstones respiratory product
portfolio with ZYFLO CR;
|
|
|
|
the view that the combination with Critical Therapeutics would
result in a combined company with the potential for enhanced
future growth and value as compared to Cornerstone as an
independent, standalone company;
|
|
|
|
the likely greater range of options available to the combined
company to access private and public equity markets should
additional capital be needed in the future than the range of
options available to Cornerstone as a private company; and
|
|
|
|
the possibility of other alternatives to expand
Cornerstones product portfolio through the acquisition of
rights to
FDA-approved
respiratory products through asset purchase or licensing
transactions not involving a strategic combination with another
company.
|
Opinion
of Critical Therapeutics Financial Advisor (see
page 113)
In connection with the merger, Critical Therapeutics board
of directors received an opinion, dated May 1, 2008, from
Critical Therapeutics financial advisor, Lazard
Frères & Co. LLC, or Lazard, as to the fairness,
from a financial point of view and as of the date of such
opinion, to Critical Therapeutics of the exchange ratio provided
for in the merger. The full text of Lazards opinion, which
sets forth, among other things, the procedures followed,
assumptions made, matters considered and qualifications and
limitations on the review
3
undertaken by Lazard in connection with its opinion, is attached
to this proxy statement/prospectus as Annex D and is
incorporated by reference into this proxy statement/prospectus.
Lazards opinion was addressed to Critical
Therapeutics board of directors, was only one of many
factors considered by Critical Therapeutics board of
directors in its evaluation of the merger and only addresses the
fairness of the exchange ratio from a financial point of view to
Critical Therapeutics. Lazards opinion does not address
the merits of the underlying decision by Critical Therapeutics
to engage in the merger or related transactions or the relative
merits of the merger or related transactions as compared to any
other transaction or business strategy in which Critical
Therapeutics might engage, and is not intended to, and does not,
constitute a recommendation to any stockholder as to how such
stockholder should vote or act with respect to the merger or any
matter relating to the merger.
Overview
of the Merger Agreement
Merger
Consideration (see page 137)
At the effective time of the merger, each share of
Cornerstones common stock will be converted into and
exchanged for the right to receive a number of shares of
Critical Therapeutics common stock equal to the product of
2.3333 multiplied by the quotient of 43,479,198, which was the
number of outstanding shares of Critical Therapeutics
common stock on April 30, 2008, divided by the number of
shares of Cornerstones common stock outstanding
immediately prior to the effective time of the merger, assuming
the exercise or conversion of all outstanding Cornerstone stock
options and warrants, subject to adjustment for the reverse
stock split of Critical Therapeutics common stock. The
exact exchange ratio per share of Cornerstones common
stock will be based in part on the number of shares of
Cornerstones common stock outstanding or issuable pursuant
to outstanding options and warrants immediately prior to the
effective time of the merger and will not be calculated until
that time.
Conditions
to Completion of the Merger (see page 138)
Consummation of the merger is subject to a number of conditions,
including among others, subject to specified exceptions, the
following:
|
|
|
|
|
the approval by Critical Therapeutics stockholders of the
issuance of Critical Therapeutics common stock in the
merger, the reverse stock split and the name change to
Cornerstone Therapeutics Inc.;
|
|
|
|
the effectiveness of Critical Therapeutics registration
statement on
Form S-4,
of which this proxy statement/prospectus forms a part, with no
stop order initiated, pending or threatened by the SEC;
|
|
|
|
the absence of any order, preliminary or permanent injunction or
statute, rule or regulation of any court or other governmental
or regulatory authority prohibiting consummation of the merger;
|
|
|
|
the approval by The NASDAQ Stock Market LLC, or NASDAQ, of the
re-listing of Critical Therapeutics common stock on The
NASDAQ Capital Market pursuant to NASDAQs reverse
merger rules and the initial listing of Critical
Therapeutics common stock issuable in connection with the
merger or upon exercise of Cornerstones outstanding stock
options or warrants;
|
|
|
|
the continued commercial availability of Critical
Therapeutics products, ZYFLO CR or ZYFLO;
|
|
|
|
the exchange or conversion of the outstanding principal amount
of that certain Promissory Note, dated April 19, 2004, as
amended, or the Carolina Note, issued by a wholly owned
subsidiary of Cornerstone, into shares of Cornerstones
common stock;
|
|
|
|
the exercise of appraisal rights by holders of not more than 5%
of Cornerstones outstanding common stock; and
|
|
|
|
the absence of any material adverse change, event, circumstance
or development with respect to, or material adverse effect on,
the business, assets, liabilities, condition (financial or
other) or results of operations of either Critical Therapeutics
or Cornerstone.
|
4
No
Solicitation (see page 140)
Each of Cornerstone and Critical Therapeutics agreed that,
subject to specified exceptions, Cornerstone and Critical
Therapeutics will not, nor will either of them authorize or
permit any of their or their respective subsidiaries
subsidiaries or any of their or their subsidiaries
respective officers, directors, investment bankers, attorneys,
accountants or other advisors or representatives to, directly or
indirectly:
|
|
|
|
|
solicit, initiate, encourage or take any other action designed
to facilitate any inquiries or the making of any proposal or
offer that constitutes, or could reasonably be expected to lead
to, any acquisition proposal, as defined in the
merger agreement and explained in this proxy
statement/prospectus; or
|
|
|
|
enter into, continue or otherwise participate in any discussions
or negotiations regarding, furnish to any person any information
with respect to, assist or participate in any effort or attempt
by any person with respect to, or otherwise cooperate in any way
with, any acquisition proposal.
|
Termination
of the Merger Agreement (see page 147)
The merger agreement may be terminated at any time before the
completion of the merger:
|
|
|
|
|
by mutual written consent of Cornerstone and Critical
Therapeutics;
|
|
|
|
by either Cornerstone or Critical Therapeutics if the merger has
not been completed by November 30, 2008, unless the failure
to complete the merger is due to the terminating partys
failure to fulfill any obligation under the merger agreement;
|
|
|
|
by either Cornerstone or Critical Therapeutics if the merger is
permanently restrained, enjoined or otherwise prohibited by a
governmental entity;
|
|
|
|
by either Cornerstone or Critical Therapeutics if Critical
Therapeutics stockholders do not approve the proposals
presented at the special meeting, unless:
|
|
|
|
|
|
the party seeking to terminate is in breach of or has failed to
fulfill its obligations under the merger agreement, or
|
|
|
|
Critical Therapeutics is seeking to terminate and has failed to
obtain the requisite vote due to a breach by any party other
than Cornerstone of the stockholder agreements entered into with
Critical Therapeutics stockholders in connection with the
merger;
|
|
|
|
|
|
by Critical Therapeutics if:
|
|
|
|
|
|
Cornerstones board of directors fails to make, withdraws
or modifies its recommendation that Cornerstones
stockholders vote to approve the merger agreement and the merger,
|
|
|
|
after the receipt by Cornerstone of an acquisition proposal,
Cornerstones board of directors fails to reconfirm its
recommendation of the merger agreement or the merger,
|
|
|
|
Cornerstones board of directors approves or recommends any
acquisition proposal,
|
|
|
|
a tender or exchange offer for Cornerstones common stock
is commenced and Cornerstones board of directors
recommends that Cornerstones stockholders tender their
shares in such offer or fails to recommend against acceptance of
such offer, or
|
|
|
|
Cornerstone breaches its non-solicitation obligations;
|
|
|
|
|
|
Critical Therapeutics board of directors fails to make,
withdraws or modifies its recommendation that Critical
Therapeutics stockholders vote for the proposals presented
at the special meeting,
|
|
|
|
after the receipt by Critical Therapeutics of an acquisition
proposal, Critical Therapeutics board of directors fails
to reconfirm its recommendation of the merger agreement or the
merger,
|
|
|
|
Critical Therapeutics board of directors approves or
recommends any acquisition proposal,
|
5
|
|
|
|
|
a tender or exchange offer for Critical Therapeutics
common stock is commenced (other than by Cornerstone or its
affiliates) and Critical Therapeutics board of directors
recommends that Critical Therapeutics stockholders tender
their shares in such offer or fails to recommend against
acceptance of such offer,
|
|
|
|
Critical Therapeutics breaches its non-solicitation obligations
or stockholder covenants, or
|
|
|
|
Critical Therapeutics fails to hold the special meeting by
November 28, 2008; or
|
|
|
|
|
|
by either Cornerstone or Critical Therapeutics if there has been
a breach of or failure to perform any representation, warranty,
covenant or agreement by the other party that would cause
conditions to the closing of the merger not to be satisfied, and
such failure or breach is not cured within 30 days after
receipt of written notice from the non-breaching party, provided
that such 30 day period may not extend beyond
November 26, 2008.
|
Termination
Fees and Expenses (see page 148)
The merger agreement provides for the payment of a termination
fee of $1.0 million by each of Critical Therapeutics and
Cornerstone to the other party in specified circumstances in
connection with the termination of the merger agreement. In
addition, in specified circumstances in connection with
termination of the merger agreement, Critical Therapeutics has
agreed to reimburse Cornerstone for up to $150,000 in expenses,
and Cornerstone has agreed to reimburse Critical Therapeutics
for up to $100,000 in expenses.
Stockholder
Agreements and Noteholder Agreement (see
page 151)
In connection with the execution of the merger agreement,
holders of approximately 81% of the shares of Cornerstones
outstanding common stock have entered into agreements with
Critical Therapeutics that provide, among other things, that the
stockholders will vote in favor of adoption of the merger
agreement and grant to Critical Therapeutics an irrevocable
proxy to vote all of such stockholders shares of
Cornerstone common stock in favor of adoption of the merger
agreement and against any proposal made in opposition to, or in
competition with, the proposal to adopt the merger agreement. In
addition, these Cornerstone stockholders have agreed not to
transfer or otherwise dispose of any shares of Critical
Therapeutics common stock that they receive in the merger
for 180 days after the effective time of the merger.
Furthermore, Carolina Pharmaceuticals Ltd., or Carolina
Pharmaceuticals, which is the holder of the Carolina Note, has
entered into an agreement that provides, among other things, for
the exchange or conversion of the outstanding principal amount
of the Carolina Note into approximately 18% of the shares of
Cornerstones common stock outstanding immediately prior to
the effective time of the merger and for the same voting and
lock-up
provisions provided for pursuant to the agreements that
Cornerstones other stockholders have entered into.
In connection with the execution of the merger agreement, funds
managed by Healthcare Ventures and Advanced Technology Ventures,
which, as of May 1, 2008, owned in the aggregate
approximately 19% of Critical Therapeutics outstanding
common stock, have entered into agreements with Cornerstone that
provide, among other things, that the stockholders will vote in
favor of the issuance of shares of Critical Therapeutics
common stock in the merger and grant to Cornerstone an
irrevocable proxy to vote such stockholders shares of
Critical Therapeutics common stock in favor of the
issuance of Critical Therapeutics common stock in the
merger and against any proposal made in opposition to, or in
competition with, the issuance of shares of Critical
Therapeutics common stock in the merger.
6
Management
Following the Merger (see page 294)
Promptly following the effective time of the merger, the
executive management team of the combined company is expected to
be composed primarily of current Cornerstone executives,
including the following individuals:
|
|
|
|
|
Name
|
|
Position with the Combined Company
|
|
Current Position
|
|
Craig A. Collard
|
|
President and Chief Executive Officer
|
|
Cornerstones President and Chief Executive Officer
|
Chenyqua Baldwin
|
|
Vice President, Finance, Chief Accounting Officer and Controller
|
|
Cornerstones Vice President, Finance
|
Brian Dickson, M.D.
|
|
Chief Medical Officer
|
|
Cornerstones Chief Medical Officer
|
George Esgro
|
|
Vice President, Sales and Marketing
|
|
Cornerstones Vice President, Sales and Marketing
|
Steven M. Lutz
|
|
Executive Vice President, Manufacturing and Trade
|
|
Cornerstones Executive Vice President, Commercial
Operations
|
David Price
|
|
Executive Vice President, Finance, and Chief Financial Officer
|
|
Cornerstones Executive Vice President, Finance, and Chief
Financial Officer
|
In addition, Scott B. Townsend, Critical Therapeutics
General Counsel, Senior Vice President of Legal Affairs and
Secretary, is expected to serve as General Counsel, Executive
Vice President of Legal Affairs and Secretary of the combined
company.
The Board
of Directors Following the Merger (see page 297)
Pursuant to the merger agreement, promptly following the
effective time of the merger, Critical Therapeutics has agreed
to take all necessary actions to appoint Craig A. Collard,
Cornerstones President and Chief Executive Officer and a
member of Cornerstones board of directors, and Alastair
McEwan, the Chairman of Cornerstones board of directors,
to Critical Therapeutics board of directors. In addition,
Critical Therapeutics has agreed to take all necessary actions
to obtain the resignations of its current directors.
Contemporaneously with the resignation of Critical
Therapeutics current directors and the appointment of
Craig A. Collard and Alastair McEwan to Critical
Therapeutics board of directors, the size of Critical
Therapeutics board of directors will be fixed at five
directors and Christopher Codeanne, Michael Enright and Michael
Heffernan will be appointed to fill the other vacancies on
Critical Therapeutics board of directors, provided that
such directors are independent under applicable NASDAQ
requirements or SEC regulations. Following the effective time of
the merger, Critical Therapeutics board of directors will
remain divided into three classes, with one class being elected
each year and members of each class holding office for a
three-year term. Based on the foregoing, the members of each
class of Critical Therapeutics board of directors will be
as follows: Class I Director (term to expire at the 2011
annual meeting of stockholders): Craig A. Collard; Class II
Directors (terms to expire at the 2009 annual meeting of
stockholders): Christopher Codeanne and Michael Enright; and
Class III Directors (terms to expire at the 2010 annual
meeting of stockholders): Alastair McEwan and Michael Heffernan.
Interests
of Critical Therapeutics Directors and Executive Officers
(see page 119)
In considering the recommendation of Critical Therapeutics
board of directors with respect to issuing shares of Critical
Therapeutics common stock pursuant to the merger agreement
and the other matters to be acted upon by Critical
Therapeutics stockholders at the special meeting, Critical
Therapeutics stockholders should be aware that members of
the board of directors and executive officers of Critical
Therapeutics have interests in the merger that may be different
from, or in addition to, interests they may have as Critical
Therapeutics stockholders.
7
For example, pursuant to the terms of employment agreements with
Critical Therapeutics executive officers and a
change of control cash bonus program established by
Critical Therapeutics, upon the consummation of the merger, the
executive officers of Critical Therapeutics are entitled to
receive aggregate cash payments of approximately $305,000 and
accelerated vesting of restricted stock with an aggregate value
of approximately $16,978, assuming that the merger had been
consummated on September 15, 2008. Assuming each executive
officer of Critical Therapeutics is terminated other than for
cause or terminates his employment for good
reason, in each case as those terms are defined in his
employment agreement, within specified periods before or after
the consummation of the merger, then the executive officers of
Critical Therapeutics would be entitled to receive aggregate
cash payments of approximately $1,814,318, accelerated vesting
of restricted stock with an aggregate value of approximately
$33,956 and additional aggregate payments of approximately
$88,150 for COBRA premiums for continued health and dental
coverage, premiums for life insurance and disability insurance
and outplacement services, assuming that the merger had been
consummated on September 15, 2008. Although the executive
officers and directors of Critical Therapeutics are entitled to
accelerated vesting of unvested stock options in connection with
the merger, all stock options subject to accelerated vesting
have an exercise price that is greater than $0.22 per share, the
closing market price of Critical Therapeutics common stock
on September 15, 2008. Unvested stock options held by
executive officers and directors of Critical Therapeutics that
are subject to accelerated vesting have exercise prices ranging
from $1.05 to $8.58 per share and a weighted average exercise
price of $3.32 per share. Following the effective time of the
merger, the executive management team of the combined company is
expected to be composed primarily of current Cornerstone
executives. It is not expected that any of the current executive
officers or directors of Critical Therapeutics will continue his
or her service with the combined company following the
merger, other than Scott B. Townsend, Critical
Therapeutics General Counsel, Senior Vice President of
Legal Affairs and Secretary.
In anticipation of Mr. Townsends service to the
combined company following the merger, on September 16,
2008, Critical Therapeutics entered into an amendment to the
amended and restated employment agreement between Critical
Therapeutics and Mr. Townsend. This amendment will be
effective from the effective time of the merger to
December 31, 2010 and will only become effective if the
merger is consummated. Under the terms of this amendment,
Mr. Townsend will serve as the General Counsel, Executive
Vice President of Legal Affairs and Secretary of the combined
company. The amendment provides for an increase in
Mr. Townsends annual target cash bonus as a
percentage of base salary from 30% to 35% and an actual annual
cash bonus for Mr. Townsend for 2008 of not less than 35%
of his base salary if he remains an employee in good standing
through December 31, 2008. Mr. Townsend will continue
to receive an annual base salary of $275,000. In connection with
such amendment, Critical Therapeutics also entered into a
restricted stock agreement with Mr. Townsend that provides
for a restricted stock grant to Mr. Townsend on the first
business day after the consummation of the merger of a number of
shares of common stock representing one percent of the combined
companys outstanding equity, on a fully diluted basis but
excluding an aggregate of 7,208,707 shares of Critical
Therapeutics common stock underlying warrants issued in
connection with a June 2005 private placement and an
October 2006 registered offering, after giving effect to the
reverse stock split and the merger, subject to the terms of such
restricted stock agreement. The restricted stock agreement will
only become effective if the merger is consummated. It is
expected that approximately 1,489,789 shares will be issued
to Mr. Townsend pursuant to the restricted stock agreement,
subject to adjustment as a result of the reverse stock split.
The amendment to Mr. Townsends amended and restated
employment agreement also provides for additional potential
future benefits to Mr. Townsend in connection with a
termination of his employment by the combined company other than
for cause or by Mr. Townsend for good reason.
Assuming that the merger had been consummated on
September 15, 2008, the beneficial ownership and other
equity interests of Mr. Townsend in the combined company
immediately following the merger are expected to be as set forth
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
Options
|
|
Company
|
|
|
Shares
|
|
Total
|
|
Exercisable
|
|
Beneficial
|
|
|
Beneficially
|
|
Options
|
|
Within
|
|
Ownership
|
Name
|
|
Owned
|
|
Held
|
|
60 Days
|
|
Percentage
|
|
Scott B. Townsend
|
|
|
1,751,672
|
|
|
|
244,000
|
|
|
|
167,015
|
|
|
|
1.4
|
%
|
8
As of September 15, 2008, all directors and executive
officers of Critical Therapeutics, together with their
affiliates, beneficially owned approximately 23.2% of the shares
of Critical Therapeutics common stock. The affirmative
vote of the holders of a majority of the shares of Critical
Therapeutics common stock present in person or represented
by proxy and voting on such matter at the special meeting is
required for approval of Proposal 1 and Proposal 4.
The affirmative vote of holders of a majority of the outstanding
shares of Critical Therapeutics common stock as of the
record date for the special meeting is required for approval of
Proposal 2 and Proposal 3.
Interests
of Cornerstones Directors and Executive Officers (see
page 125)
Critical Therapeutics stockholders also should be aware
that members of the board of directors and executive officers of
Cornerstone have interests in the merger that may be different
from, or in addition to, interests they may have as Cornerstone
stockholders.
Cornerstones executive officers are expected to continue
as executive officers of the combined company with initial
annual base salaries following the merger that are identical to
their respective annual base salaries with Cornerstone
immediately prior to the merger. These individuals, their
expected positions and annual base salaries with the combined
company are as follows:
|
|
|
|
|
Craig A. Collard, President and Chief Executive Officer, annual
base salary of $379,600;
|
|
|
|
Chenyqua Baldwin, Vice President, Finance, Chief Accounting
Officer and Controller, annual base salary of $223,600;
|
|
|
|
Brian Dickson, M.D., Chief Medical Officer, annual base
salary of $270,400;
|
|
|
|
George Esgro, Vice President, Sales and Marketing, annual base
salary of $220,000;
|
|
|
|
Steven M. Lutz, Executive Vice President, Manufacturing and
Trade, annual base salary of $250,000; and
|
|
|
|
David Price, Executive Vice President, Finance, and Chief
Financial Officer, annual base salary of $285,000.
|
As of May 2, 2008, the date that holders of a majority of
the shares of Cornerstones outstanding common stock acting
by written consent without a meeting in accordance with
Section 228 of the Delaware General Corporation Law and
Cornerstones bylaws approved the merger agreement and the
transactions contemplated thereby, Mr. Collard controlled,
directly or indirectly, 54% of the outstanding shares of
Cornerstones common stock, and Cornerstones
executive officers and directors, and their affiliates, in the
aggregate controlled, directly or indirectly, 68.3% of the
outstanding shares of Cornerstones common stock.
Assuming that the merger had been consummated on
September 15, 2008, Cornerstones executive officers
and directors, and their affiliates, would beneficially own, in
the aggregate, approximately 51% of the outstanding common stock
of the combined company, including any shares of the common
stock of the combined company issuable in the merger in exchange
for shares of Cornerstones outstanding common stock to be
issued to Carolina Pharmaceuticals upon the exchange or
conversion prior to the merger of the outstanding principal
amount under the Carolina Note into shares of Cornerstones
common stock pursuant to the noteholder agreement between
Carolina Pharmaceuticals and Critical Therapeutics.
Additionally, Cornerstones executive officers and
directors would hold certain options to acquire shares of the
common stock of the combined company that are not considered
beneficially owned because such options are not exercisable
within sixty days of September 15, 2008. Assuming that the
merger had been consummated on September 15, 2008 and
assuming an exchange ratio of
9
2.449169, the beneficial ownership and other equity interests of
Cornerstones executive officers and directors, and their
affiliates, in the combined company immediately following the
merger are expected to be as set forth below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Combined
|
|
|
Total
|
|
|
|
Options
|
|
Company
|
|
|
Shares
|
|
Total
|
|
Exercisable
|
|
Beneficial
|
|
|
Beneficially
|
|
Options
|
|
Within
|
|
Ownership
|
Name
|
|
Owned
|
|
Held
|
|
60 Days
|
|
Percentage
|
|
Craig A. Collard(1)
|
|
|
48,115,201
|
|
|
|
2,571,627
|
|
|
|
734,750
|
|
|
|
38.2
|
%
|
Chenyqua Baldwin
|
|
|
2,430,799
|
|
|
|
2,057,301
|
|
|
|
593,923
|
|
|
|
1.9
|
|
Brian Dickson, M.D.
|
|
|
1,637,881
|
|
|
|
3,673,752
|
|
|
|
1,637,881
|
|
|
|
1.3
|
|
George Esgro(2)
|
|
|
|
|
|
|
734,750
|
|
|
|
|
|
|
|
|
|
Steven M. Lutz
|
|
|
7,656,712
|
|
|
|
2,265,480
|
|
|
|
688,828
|
|
|
|
6.1
|
|
Alastair McEwan
|
|
|
2,755,314
|
|
|
|
3,673,752
|
|
|
|
2,755,314
|
|
|
|
2.2
|
|
David Price(3)
|
|
|
3,188,268
|
|
|
|
|
|
|
|
|
|
|
|
2.5
|
|
|
|
|
(1) |
|
Total shares beneficially owned consists of
32,941,317 shares of common stock held by Cornerstone
Biopharma Holdings, Ltd., 14,439,134 shares of common stock
held by Carolina Pharmaceuticals received in connection with the
conversion of the outstanding principal amount under the
Carolina Note and options to purchase 734,239 shares of
common stock pursuant to stock option grants awarded to
Mr. Collard under Cornerstones 2005 Stock Incentive
Plan. Mr. Collard is the controlling shareholder and a
director of Cornerstone Biopharma Holdings, Ltd. and by virtue
of such positions will exercise voting and investment power with
respect to the shares of the combined company to be owned by
Cornerstone Biopharma Holdings, Ltd. following the merger.
Mr. Collard is the chief executive officer and chairman of
the board of Carolina Pharmaceuticals and by virtue of such
positions will exercise voting and investment power with respect
to the shares of the combined company to be owned by Carolina
Pharmaceuticals following the merger. |
|
(2) |
|
Pursuant to the Employment Agreement, dated March 3, 2008,
between Cornerstone and Mr. Esgro, Cornerstone is obligated
to grant Mr. Esgro an option to purchase
300,000 shares of Cornerstones common stock.
Cornerstone expects that the option award to Mr. Esgro will
be completed immediately prior to the effective time of the
merger. |
|
(3) |
|
Mr. Price became the Executive Vice President, Finance, and
Chief Financial Officer of Cornerstone effective as of
September 8, 2008. Pursuant to the Executive Employment
Agreement, dated August 20, 2008, between Cornerstone and
Mr. Price, Cornerstone is obligated to issue to
Mr. Price 1,301,776 restricted shares of Cornerstone common
stock. Cornerstone expects that this restricted stock award to
Mr. Price will be completed immediately prior to the
effective time of the merger. In connection with the merger,
Mr. Prices 1,301,776 restricted shares of Cornerstone
common stock will be converted into restricted shares of the
combined companys common stock. |
Carolina Pharmaceuticals, which is the holder of the Carolina
Note, has entered into an agreement with Critical Therapeutics
that provides, among other things, for the exchange or
conversion prior to the merger of the outstanding principal
amount of the Carolina Note into shares of Cornerstones
common stock. Mr. Collard is the Chief Executive Officer
and Chairman of the Board of Carolina Pharmaceuticals. In
addition, Ms. Baldwin and Mr. Lutz are directors of
Carolina Pharmaceuticals. As of September 15, 2008, the
outstanding principal amount of the Carolina Note was
approximately $9.0 million, which assuming an exchange
ratio of 2.449169 would be converted into approximately
14,439,134 shares, or 11.5%, of the combined companys
outstanding common stock immediately following the consummation
of the merger.
Stock
Options and Warrants (see page 128)
Each outstanding option to purchase shares of Cornerstone common
stock, whether vested or unvested, and all stock option plans or
other stock or equity-related plans of Cornerstone themselves,
insofar as they relate to outstanding Cornerstones stock
options, will be assumed by Critical Therapeutics and will
become an option to acquire, on the same terms and conditions as
were applicable under such Cornerstones stock option
immediately prior to the effective time of the merger, such
number of shares of Critical Therapeutics common stock as
is equal to the number of shares of Cornerstones common
stock subject to the unexercised portion of such Cornerstone
stock option immediately prior to the effective time of the
merger multiplied by the exchange ratio
10
(rounded down to the nearest whole share number), at an exercise
price per share equal to the exercise price per share of such
Cornerstone stock option immediately prior to the effective time
of the merger divided by the exchange ratio (rounded up to the
nearest whole cent). To the extent not exercised prior to the
consummation of the merger, Cornerstone anticipates that there
will be approximately 7,951,871 shares of
Cornerstones common stock underlying outstanding stock
options immediately prior to the effective time of the merger.
Each warrant to purchase shares of Cornerstone common stock
outstanding immediately prior to the effective time of the
merger will be assumed by Critical Therapeutics and will become
a warrant to acquire, on the same terms and conditions as were
applicable under such warrant, such number of shares of Critical
Therapeutics common stock as is equal to the number of
shares of Cornerstones common stock subject to the
unexercised portion of such Cornerstone warrant immediately
prior to the effective time of the merger multiplied by the
exchange ratio (rounded down to the nearest whole share number),
at an exercise price per share equal to the exercise price per
share of such Cornerstone warrant immediately prior to the
effective time of the merger divided by the exchange ratio
(rounded up to the nearest whole cent). Cornerstone anticipates
that warrants to purchase an aggregate of 1,326,903 shares
of Cornerstones common stock underlying warrants
outstanding as of September 15, 2008 will be exercised
prior to the effective time of the merger. Following such
exercises, Cornerstone anticipates that there will be
20,000 shares of Cornerstones common stock underlying
outstanding warrants immediately prior to the effective time of
the merger.
As of the effective time of the reverse stock split, Critical
Therapeutics will adjust and proportionately decrease the number
of shares of Critical Therapeutics common stock reserved
for issuance upon exercise of, and adjust and proportionately
increase the exercise price of, all options and warrants to
acquire Critical Therapeutics common stock. In addition,
as of the effective time of the reverse stock split, Critical
Therapeutics will adjust and proportionately decrease the total
number of shares of Critical Therapeutics common stock
that may be the subject of future grants under Critical
Therapeutics stock option plans. All stock options and
warrants to acquire shares of Critical Therapeutics common
stock that are outstanding immediately prior to the effective
time of the merger will remain outstanding following the
effective time of the merger.
Material
U.S. Federal Income Tax Consequences of the Merger (see
page 130)
The merger has been structured to qualify as a reorganization
within the meaning of Section 368(a) of the Internal
Revenue Code of 1986, as amended, or the Code, and it is a
closing condition to the merger that Critical Therapeutics and
Cornerstone receive opinions of their respective counsel
regarding such qualification. There will be no U.S. federal
income tax consequences to Critical Therapeutics
stockholders as a result of the merger. As a result of the
mergers qualification as a reorganization,
Cornerstones stockholders will not recognize gain or loss
for U.S. federal income tax purposes upon the exchange of
shares of Cornerstones common stock for shares of Critical
Therapeutics common stock, except with respect to cash
received in lieu of fractional shares of Critical
Therapeutics common stock.
Tax matters are very complicated, and the tax consequences of
the merger to a particular stockholder will depend in part on
such stockholders circumstances. Accordingly, you are
urged to consult your own tax advisor for a full understanding
of the tax consequences of the merger to you, including the
applicability and effect of federal, state, local and foreign
income and other tax laws.
Risk
Factors (see page 24)
Both Critical Therapeutics and Cornerstone are subject to
various risks associated with their businesses and their
industries, and the combined business will also be subject to
those and other risks. In addition, the merger poses a number of
risks to each company and its stockholders, including the
following risks:
|
|
|
|
|
Some of Critical Therapeutics and Cornerstones
officers and directors have interests in the merger that may be
different from yours and influence them to support or approve
the merger.
|
|
|
|
The merger may be completed even though material adverse changes
may result from the announcement of the merger, industry-wide
changes and other causes.
|
|
|
|
The market price of Critical Therapeutics common stock has
fallen significantly since the public announcement of the
proposed merger. If the merger is completed and the perceived
benefits of the merger are not realized, the market price of the
combined company may decline further.
|
11
|
|
|
|
|
Critical Therapeutics and Cornerstones stockholders
may not realize a benefit from the merger commensurate with the
ownership dilution they will experience in connection with the
merger.
|
|
|
|
Negative perceptions regarding the pending merger may harm
either Critical Therapeutics or Cornerstones
business and employee relationships.
|
Regulatory
Approvals (see page 130)
Neither Critical Therapeutics nor Cornerstone is required to
make any filings or to obtain approvals or clearances from any
antitrust regulatory authorities in the United States or other
countries to consummate the merger. In the United States,
Critical Therapeutics must comply with applicable federal and
state securities laws and NASDAQ rules and regulations in
connection with the issuance of shares of Critical
Therapeutics common stock in the merger, including the
filing with the SEC of this proxy statement/prospectus. Critical
Therapeutics has filed an initial listing application with The
NASDAQ Capital Market pursuant to NASDAQs reverse
merger rules for the
re-listing
of Critical Therapeutics common stock in connection with
the merger and to effect the initial listing of Critical
Therapeutics common stock issuable in connection with the
merger or upon exercise of Cornerstones outstanding stock
options or warrants.
Anticipated
Accounting Treatment (see page 134)
The merger will be treated by Critical Therapeutics as a reverse
merger under the purchase method of accounting in accordance
with U.S. generally accepted accounting principles, or
GAAP. For accounting purposes, Cornerstone is considered to be
acquiring Critical Therapeutics in this transaction.
Appraisal
Rights (see page 134)
Critical Therapeutics stockholders are not entitled to
appraisal rights in connection with the merger or any of the
proposals to be voted on at the special meeting.
Cornerstones stockholders are entitled to appraisal rights
if they did not vote in favor of the merger agreement and they
comply with the conditions established by Section 262 of
the Delaware General Corporation Law.
It is a condition to the obligation of Critical Therapeutics and
the transitory subsidiary to complete the merger that holders of
not more than 5% of Cornerstones outstanding common stock
exercise appraisal rights.
Comparison
of Stockholder Rights (see page 339)
Both Critical Therapeutics and Cornerstone are incorporated
under the laws of the State of Delaware and, accordingly, the
rights of the stockholders of each are currently, and will
continue to be, governed by the Delaware General Corporation
Law. If the merger is completed, Cornerstones stockholders
will become stockholders of Critical Therapeutics, and their
rights will be governed by the Delaware General Corporation Law,
the certificate of incorporation of Critical Therapeutics and
the bylaws of Critical Therapeutics. The rights of Critical
Therapeutics stockholders contained in the certificate of
incorporation and bylaws of Critical Therapeutics differ from
the rights of Cornerstones stockholders under the
certificate of incorporation and bylaws of Cornerstone.
Legal
Proceedings (see page 189)
On September 17, 2008, a purported shareholder class action
lawsuit was filed by a single plaintiff against Critical
Therapeutics and each of its directors in the Court of Chancery
of The State of Delaware. The complaint alleges, among other
things, that the defendants breached fiduciary duties of loyalty
and good faith, including a fiduciary duty of candor, by failing
to provide Critical Therapeutics stockholders with a proxy
statement/prospectus adequate to enable them to cast an informed
vote on the proposed merger, and by possibly failing to maximize
stockholder value by entering into an agreement that effectively
discourages competing offers. The complaint seeks, among other
things, an order (i) enjoining the defendants from
proceeding with or implementing the proposed merger on the terms
and under the circumstances as they presently exist,
(ii) invalidating the provisions of the proposed merger
that purportedly improperly limit the effective exercise of the
defendants continuing fiduciary duties;
(iii) ordering defendants to explore alternatives and to
negotiate in good faith with all bona fide interested
parties; (iv) in the event the proposed merger is
consummated, rescinding it and setting it aside or awarding
rescissory damages; (v) awarding compensatory damages
against defendants, jointly and severally; and
(vi) awarding the plaintiff and the purported class their
costs and fees.
12
SELECTED
HISTORICAL AND PRO FORMA COMBINED FINANCIAL DATA
The following tables present summary historical financial data
for Critical Therapeutics and Cornerstone, summary unaudited pro
forma condensed combined financial data for Critical
Therapeutics and Cornerstone, and comparative historical and
unaudited pro forma per share data for Critical Therapeutics and
Cornerstone.
13
Selected
Historical Consolidated Financial Data of Critical
Therapeutics
The statements of operations data for the years ended
December 31, 2007, 2006 and 2005 and the balance sheet data
as of December 31, 2007 and 2006 are derived from Critical
Therapeutics audited consolidated financial statements,
which are included in this proxy statement/prospectus beginning
on page F-3. The statements of operations data for the six
months ended June 30, 2008 and 2007 and the balance sheet
data as of June 30, 2008 and 2007 are derived from Critical
Therapeutics unaudited consolidated financial statements,
which are included in this proxy statement/prospectus beginning
on page F-36. The statements of operations data for the
years ended December 31, 2004 and 2003 and the balance
sheet data as of December 31, 2005, 2004 and 2003 are
derived from Critical Therapeutics audited consolidated
financial statements, which are not included in this proxy
statement/prospectus. Historical results are not necessarily
indicative of future results and results for any interim period
are not necessarily indicative of results to be expected for a
full fiscal year. You should read the notes to Critical
Therapeutics consolidated financial statements for an
explanation of the method used to determine the number of shares
used in computing basic and diluted net loss per share.
Effective January 1, 2006, Critical Therapeutics adopted
SFAS 123(R), using the modified prospective method, which
requires Critical Therapeutics to recognize compensation cost
for granted, but unvested, awards, new awards and awards
modified, repurchased, or cancelled after January 1, 2006
and granted after Critical Therapeutics became a public company.
The amounts for prior periods do not include the impact of
SFAS 123(R). In the notes to Critical Therapeutics
consolidated financial statements, Critical Therapeutics has
provided pro forma disclosures for the year ended
December 31, 2005 in accordance with SFAS 123 since
that period has not been retroactively adjusted to reflect the
SFAS 123 pro forma amounts in the prior period financial
statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
Year Ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
(In thousands, except share and per share data)
|
|
|
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
7,227
|
|
|
$
|
5,185
|
|
|
$
|
11,008
|
|
|
$
|
6,647
|
|
|
$
|
387
|
|
|
$
|
|
|
|
$
|
|
|
Revenue under collaboration and license agreements
|
|
|
|
|
|
|
1,737
|
|
|
|
1,861
|
|
|
|
6,431
|
|
|
|
5,837
|
|
|
|
4,436
|
|
|
|
1,021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
7,227
|
|
|
|
6,922
|
|
|
|
12,869
|
|
|
|
13,078
|
|
|
|
6,224
|
|
|
|
4,436
|
|
|
|
1,021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
4,657
|
|
|
|
1,421
|
|
|
|
4,233
|
|
|
|
2,222
|
|
|
|
514
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
6,927
|
|
|
|
13,022
|
|
|
|
21,655
|
|
|
|
26,912
|
|
|
|
29,959
|
|
|
|
25,578
|
|
|
|
17,458
|
|
Sales and marketing
|
|
|
6,031
|
|
|
|
4,582
|
|
|
|
12,193
|
|
|
|
18,284
|
|
|
|
13,671
|
|
|
|
1,199
|
|
|
|
|
|
General and administrative
|
|
|
6,010
|
|
|
|
6,588
|
|
|
|
13,572
|
|
|
|
13,456
|
|
|
|
11,406
|
|
|
|
9,679
|
|
|
|
3,771
|
|
Restructuring charges
|
|
|
1,204
|
|
|
|
|
|
|
|
|
|
|
|
3,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
24,829
|
|
|
|
25,613
|
|
|
|
51,653
|
|
|
|
64,372
|
|
|
|
55,550
|
|
|
|
36,456
|
|
|
|
21,229
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(17,602
|
)
|
|
|
(18,691
|
)
|
|
|
(38,784
|
)
|
|
|
(51,294
|
)
|
|
|
(49,326
|
)
|
|
|
(32,020
|
)
|
|
|
(20,208
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
289
|
|
|
|
1,154
|
|
|
|
2,020
|
|
|
|
2,726
|
|
|
|
2,427
|
|
|
|
1,098
|
|
|
|
191
|
|
Interest expense
|
|
|
(85
|
)
|
|
|
(69
|
)
|
|
|
(209
|
)
|
|
|
(214
|
)
|
|
|
(191
|
)
|
|
|
(172
|
)
|
|
|
(93
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(17,398
|
)
|
|
|
(17,606
|
)
|
|
|
(36,973
|
)
|
|
|
(48,782
|
)
|
|
|
(47,090
|
)
|
|
|
(31,094
|
)
|
|
|
(20,110
|
)
|
Accretion of dividends and offering costs on preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,209
|
)
|
|
|
(2,264
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common stockholders
|
|
$
|
(17,398
|
)
|
|
$
|
(17,606
|
)
|
|
$
|
(36,973
|
)
|
|
$
|
(48,782
|
)
|
|
$
|
(47,090
|
)
|
|
$
|
(33,303
|
)
|
|
$
|
(22,374
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
$
|
(0.41
|
)
|
|
$
|
(0.41
|
)
|
|
$
|
(0.87
|
)
|
|
$
|
(1.37
|
)
|
|
$
|
(1.61
|
)
|
|
$
|
(2.28
|
)
|
|
$
|
(33.99
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average basic and diluted shares outstanding
|
|
|
42,857,558
|
|
|
|
42,513,852
|
|
|
|
42,580,884
|
|
|
|
35,529,048
|
|
|
|
29,276,243
|
|
|
|
14,631,371
|
|
|
|
658,204
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
(In thousands)
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
10,952
|
|
|
$
|
39,813
|
|
|
$
|
33,828
|
|
|
$
|
48,388
|
|
|
$
|
57,257
|
|
|
$
|
11,980
|
|
|
$
|
40,078
|
|
Short-term investments
|
|
|
|
|
|
|
650
|
|
|
|
|
|
|
|
650
|
|
|
|
25,554
|
|
|
|
66,849
|
|
|
|
|
|
Working capital
|
|
|
9,410
|
|
|
|
34,042
|
|
|
|
26,380
|
|
|
|
47,738
|
|
|
|
70,005
|
|
|
|
64,357
|
|
|
|
25,218
|
|
Total assets
|
|
|
23,358
|
|
|
|
50,508
|
|
|
|
44,924
|
|
|
|
58,182
|
|
|
|
91,819
|
|
|
|
83,114
|
|
|
|
45,054
|
|
Long-term debt, net of current portion
|
|
|
|
|
|
|
122
|
|
|
|
|
|
|
|
421
|
|
|
|
1,489
|
|
|
|
1,367
|
|
|
|
720
|
|
Redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51,395
|
|
Accumulated deficit
|
|
|
(208,770
|
)
|
|
|
(172,005
|
)
|
|
|
(191,372
|
)
|
|
|
(154,399
|
)
|
|
|
(105,617
|
)
|
|
|
(58,527
|
)
|
|
|
(27,433
|
)
|
Total stockholders equity (deficit)
|
|
|
1,176
|
|
|
|
34,637
|
|
|
|
17,091
|
|
|
|
49,906
|
|
|
|
72,247
|
|
|
|
65,408
|
|
|
|
(24,851
|
)
|
15
Selected
Historical Consolidated Financial Data of Cornerstone
The statements of operations data for the years ended
December 31, 2007, 2006 and 2005 and the balance sheet data
as of December 31, 2007 and 2006 are derived from
Cornerstones audited consolidated financial statements,
which are included in this proxy statement/prospectus beginning
on
page F-54.
The statements of operations data for the six months ended
June 30, 2008 and 2007 and the balance sheet data as of
June 30, 2008 and 2007 are derived from Cornerstones
unaudited consolidated financial statements, which are included
in this proxy statement/prospectus beginning on
page F-88.
The statement of operations data for the period March 30,
2004 (date of inception) through December 31, 2004 and the
balance sheet data as of December 31, 2005 and 2004 are
derived from Cornerstones audited consolidated financial
statements, which are not included in this proxy
statement/prospectus. Historical results are not necessarily
indicative of future results and results for any interim period
are not necessarily indicative of results to be expected for a
full fiscal year. You should read the notes to
Cornerstones consolidated financial statements for an
explanation of the method used to determine the number of shares
used in computing basic and diluted net loss per share.
Effective January 1, 2006, Cornerstone adopted
SFAS 123(R), using the prospective method, which requires
Cornerstone to recognize compensation cost for new awards and
awards modified, repurchased or cancelled on or after
January 1, 2006. The amounts for prior periods do not
include the impact of SFAS 123(R). In the notes to
Cornerstones consolidated financial statements,
Cornerstone has provided pro forma disclosures for the year
ended December 31, 2005 in accordance with SFAS 123
since that period has not been restated to conform to the 2007
and 2006 presentation.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004
|
|
|
|
Six Months Ended
|
|
|
|
|
|
|
|
|
|
|
|
(Inception) through
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
Year Ended December 31,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
(In thousands, except share and per share data)
|
|
|
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
23,512
|
|
|
$
|
14,203
|
|
|
$
|
28,071
|
|
|
$
|
22,117
|
|
|
$
|
17,470
|
|
|
$
|
5,740
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales
|
|
|
1,498
|
|
|
|
1,516
|
|
|
|
3,300
|
|
|
|
2,151
|
|
|
|
3,437
|
|
|
|
2,076
|
|
Sales and marketing
|
|
|
7,534
|
|
|
|
4,852
|
|
|
|
10,391
|
|
|
|
7,120
|
|
|
|
13,889
|
|
|
|
2,867
|
|
Royalties
|
|
|
4,804
|
|
|
|
1,631
|
|
|
|
3,409
|
|
|
|
1,663
|
|
|
|
1,933
|
|
|
|
689
|
|
General and administrative
|
|
|
3,773
|
|
|
|
2,078
|
|
|
|
4,106
|
|
|
|
3,679
|
|
|
|
4,881
|
|
|
|
1,020
|
|
Research and development
|
|
|
605
|
|
|
|
113
|
|
|
|
948
|
|
|
|
249
|
|
|
|
266
|
|
|
|
|
|
Amortization and depreciation
|
|
|
886
|
|
|
|
1,686
|
|
|
|
3,231
|
|
|
|
2,704
|
|
|
|
1,939
|
|
|
|
8
|
|
Other charges
|
|
|
27
|
|
|
|
131
|
|
|
|
245
|
|
|
|
3,581
|
|
|
|
1,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
19,127
|
|
|
|
12,007
|
|
|
|
25,630
|
|
|
|
21,147
|
|
|
|
27,345
|
|
|
|
6,660
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
|
4,385
|
|
|
|
2,196
|
|
|
|
2,441
|
|
|
|
970
|
|
|
|
(9,875
|
)
|
|
|
(920
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net
|
|
|
(722
|
)
|
|
|
(657
|
)
|
|
|
(1,410
|
)
|
|
|
(1,240
|
)
|
|
|
(1,557
|
)
|
|
|
(782
|
)
|
Loss on marketable security
|
|
|
|
|
|
|
|
|
|
|
(324
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expenses
|
|
|
|
|
|
|
|
|
|
|
(7
|
)
|
|
|
(35
|
)
|
|
|
(6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes
|
|
|
3,663
|
|
|
|
1,539
|
|
|
|
700
|
|
|
|
(305
|
)
|
|
|
(11,438
|
)
|
|
|
(1,702
|
)
|
Provision for income taxes
|
|
|
(839
|
)
|
|
|
(534
|
)
|
|
|
(130
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
2,824
|
|
|
$
|
1,005
|
|
|
$
|
570
|
|
|
$
|
(305
|
)
|
|
$
|
(11,438
|
)
|
|
$
|
(1,702
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share, basic
|
|
$
|
0.11
|
|
|
$
|
0.04
|
|
|
$
|
0.02
|
|
|
$
|
(0.01
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share, diluted
|
|
$
|
0.10
|
|
|
$
|
0.04
|
|
|
$
|
0.02
|
|
|
$
|
(0.01
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares, basic
|
|
|
24,926,150
|
|
|
|
24,926,150
|
|
|
|
24,926,150
|
|
|
|
25,022,594
|
|
|
|
25,126,027
|
|
|
|
25,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares, diluted
|
|
|
28,776,045
|
|
|
|
27,697,832
|
|
|
|
28,356,133
|
|
|
|
25,022,594
|
|
|
|
25,126,027
|
|
|
|
25,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
(In thousands)
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
19
|
|
|
$
|
548
|
|
|
$
|
241
|
|
|
$
|
116
|
|
|
$
|
959
|
|
|
$
|
4,008
|
|
Working capital
|
|
|
(3,504
|
)
|
|
|
(5,941
|
)
|
|
|
(5,131
|
)
|
|
|
(9,230
|
)
|
|
|
(11,740
|
)
|
|
|
652
|
|
Total assets
|
|
|
21,321
|
|
|
|
13,244
|
|
|
|
15,909
|
|
|
|
10,582
|
|
|
|
16,147
|
|
|
|
21,019
|
|
Long-term debt, net of current portion
|
|
|
11,911
|
|
|
|
10,382
|
|
|
|
12,371
|
|
|
|
10,382
|
|
|
|
13,031
|
|
|
|
13,074
|
|
Accumulated deficit
|
|
|
(10,274
|
)
|
|
|
(12,663
|
)
|
|
|
(13,098
|
)
|
|
|
(13,668
|
)
|
|
|
(13,140
|
)
|
|
|
(1,702
|
)
|
Total stockholders deficit
|
|
|
(9,302
|
)
|
|
|
(12,198
|
)
|
|
|
(12,295
|
)
|
|
|
(13,844
|
)
|
|
|
(12,903
|
)
|
|
|
(1,654
|
)
|
17
Selected
Unaudited Pro Forma Condensed Combined Financial Data
of Critical Therapeutics and Cornerstone
The following unaudited pro forma condensed combined financial
statements give effect to the merger of a wholly owned
subsidiary of Critical Therapeutics and Cornerstone in a
transaction to be accounted for as a purchase with Cornerstone
treated as the acquirer even though Critical Therapeutics will
be the issuer of common stock and surviving legal entity in the
transaction (based in part on the fact that upon completion of
the merger Critical Therapeutics stockholders will retain
approximately 30% and the former Cornerstone stockholders will
own approximately 70% of the outstanding shares of Critical
Therapeutics, assuming the exchange or conversion prior to the
merger of the outstanding principal amount of the Carolina Note
into shares of Cornerstones common stock and after
giving effect to shares issuable pursuant to Cornerstones
outstanding options and warrants, but without giving effect to
any shares issuable pursuant to Critical Therapeutics
outstanding options and warrants). The unaudited pro forma
condensed statements of operations are based on the individual
historical consolidated statements of operations of Critical
Therapeutics and Cornerstone and combine the results of
operations of Critical Therapeutics and Cornerstone for the year
ended December 31, 2007 and the six months ended
June 30, 2008, giving effect to the combination as if it
occurred on January 1, 2007, reflecting only pro forma
adjustments expected to have a continuing impact on the combined
results. The unaudited pro forma condensed balance sheet
combines the historical consolidated balance sheets of Critical
Therapeutics and Cornerstone as of June 30, 2008, giving
effect to the combination as if it occurred on June 30,
2008, reflecting only pro forma adjustments expected to have a
continuing impact on the combined results. The unaudited pro
forma condensed combined financial information does not give
effect to the proposed reverse stock split as it is currently
unknown which ratio, if any, will be used.
These unaudited pro forma condensed combined financial
statements are for informational purposes only. They do not
purport to indicate the results that would have actually been
obtained had the merger been completed on the assumed date or
for the periods presented, or that may be realized in the
future. To produce the unaudited pro forma financial
information, Cornerstone, as the acquiring party, preliminarily
allocated the purchase price using its best estimates of fair
value. These estimates are based on the most recently available
information. To the extent there are significant changes to
Critical Therapeutics business, the assumptions and
estimates herein could change significantly. Furthermore, the
parties may have reorganization and restructuring expenses as
well as potential operating efficiencies as a result of
combining the companies. The pro forma financial information
does not reflect these potential expenses and efficiencies. Upon
completion of the merger, final valuations will be performed.
The unaudited pro forma condensed combined financial statements
should be read in conjunction with Critical
Therapeutics Managements Discussion and Analysis of
Financial Condition and Results of Operations and
Cornerstones Managements Discussion and
Analysis of Financial Condition and Results of Operations
and the historical consolidated financial statements, including
related notes of Critical Therapeutics and Cornerstone,
respectively, covering these periods, included in this proxy
statement/prospectus. Please see the section entitled
Where You Can Find More Information on
page 352 of this proxy statement/prospectus for more
information.
18
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
|
|
|
Ended
|
|
|
Year Ended
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(In thousands)
|
|
|
Unaudited Pro Forma Condensed Combined Statements of
Operations Data:
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
30,739
|
|
|
$
|
40,940
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
10,959
|
|
|
|
10,942
|
|
Research and development
|
|
|
7,532
|
|
|
|
22,603
|
|
Sales, general and administrative
|
|
|
25,713
|
|
|
|
45,718
|
|
Restructuring charges
|
|
|
1,204
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
45,408
|
|
|
|
79,263
|
|
Other (expense) income
|
|
|
(518
|
)
|
|
|
70
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(15,187
|
)
|
|
|
(38,253
|
)
|
Provision for income taxes
|
|
|
839
|
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(16,026
|
)
|
|
$
|
(38,383
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
|
|
|
|
|
June 30,
|
|
|
|
|
2008
|
|
|
|
|
(In thousands)
|
|
|
|
Unaudited Pro Forma Condensed Combined Balance Sheet Data:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
9,020
|
|
|
|
|
|
Working capital
|
|
|
6,528
|
|
|
|
|
|
Total assets
|
|
|
54,681
|
|
|
|
|
|
Total liabilities
|
|
|
32,652
|
|
|
|
|
|
Total stockholders equity
|
|
|
22,029
|
|
|
|
|
|
19
Comparative
Historical and Unaudited Pro Forma Per Share Data
The following information does not give effect to the reverse
stock split of Critical Therapeutics common stock
described in Proposal 2.
The information below reflects the historical net loss and book
value per share of Cornerstones common stock and the
historical net loss and book value per share of Critical
Therapeutics common stock in comparison with the unaudited
pro forma net loss and book value per share after giving effect
to the proposed merger of Critical Therapeutics with Cornerstone
on a purchase basis.
You should read the tables below in conjunction with the audited
and unaudited financial statements of Critical Therapeutics
beginning on
page F-3
of this proxy statement/prospectus and the audited and unaudited
financial statements of Cornerstone commencing at
page F-54
of this proxy statement/prospectus and the related notes and the
unaudited pro forma condensed combined financial information and
notes related to such financial statements included elsewhere in
this proxy statement/prospectus. The pro forma financial
information is presented for illustrative purposes only and is
not necessarily indicative of the results of operations that
would have resulted if the merger had been completed as of the
assumed dates or of the results that will be achieved in the
future.
The selected unaudited pro forma condensed combined financial
data as of and for the six months ended June 30, 2008 and
for the year ended December 31, 2007 are derived from the
unaudited pro forma condensed combined financial information
beginning on page 328 of this proxy statement/prospectus
and should be read in conjunction with that information. Please
see the section entitled Unaudited Pro Forma Condensed
Combined Financial Information beginning on page 327
of this proxy statement/prospectus.
CRITICAL
THERAPEUTICS
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
Year Ended
|
|
Ended
|
|
|
December 31,
|
|
June 30,
|
|
|
2007
|
|
2008
|
|
Historical Per Common Share Data:
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted
|
|
$
|
(0.87
|
)
|
|
$
|
(0.41
|
)
|
Book value per common share as of the end of the period
|
|
$
|
0.40
|
|
|
$
|
0.03
|
|
CORNERSTONE
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
Year Ended
|
|
Ended
|
|
|
December 31,
|
|
June 30,
|
|
|
2007
|
|
2008
|
|
Historical Per Common Share Data:
|
|
|
|
|
|
|
|
|
Net income per common share, basic
|
|
$
|
0.02
|
|
|
$
|
0.11
|
|
Net income per common share, diluted
|
|
$
|
0.02
|
|
|
$
|
0.10
|
|
Book value per common share as of the end of the period
|
|
$
|
(0.49
|
)
|
|
$
|
(0.37
|
)
|
20
CORNERSTONE
AND CRITICAL THERAPEUTICS
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
Year Ended
|
|
Ended
|
|
|
December 31,
|
|
June 30,
|
|
|
2007
|
|
2008
|
|
Combined Unaudited Pro Forma Per Common Share Data:
|
|
|
|
|
|
|
|
|
Net loss per combined common share from continuing operations,
basic and diluted
|
|
$
|
(0.34
|
)
|
|
$
|
(0.13
|
)
|
Book value per combined common share
|
|
$
|
0.21
|
|
|
$
|
0.18
|
|
|
|
|
|
|
|
|
|
|
Equivalent Pro Forma Per Common Share Data:
|
|
|
|
|
|
|
|
|
Net loss per combined common share from continuing operations,
basic and diluted
|
|
$
|
(0.96
|
)
|
|
$
|
(0.33
|
)
|
Book value per combined common share
|
|
$
|
0.60
|
|
|
$
|
0.46
|
|
21
MARKET
PRICE AND DIVIDEND INFORMATION
Critical Therapeutics common stock is listed on The NASDAQ
Capital Market under the symbol CRTX. From July 2006
to June 2008, Critical Therapeutics common stock traded on
the NASDAQ Global Market. Prior to July 2006, Critical
Therapeutics common stock traded on The NASDAQ National
Market. The following table sets forth, for the periods
indicated, the high and low per share sales prices for Critical
Therapeutics common stock as reported on NASDAQ.
Cornerstone is a private company and its common stock is not
publicly traded.
Critical
Therapeutics Common Stock
|
|
|
|
|
|
|
|
|
|
|
High
|
|
|
Low
|
|
|
Year Ended December 31, 2006
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
7.41
|
|
|
$
|
4.72
|
|
Second Quarter
|
|
|
6.25
|
|
|
|
3.28
|
|
Third Quarter
|
|
|
4.50
|
|
|
|
2.08
|
|
Fourth Quarter
|
|
|
3.28
|
|
|
|
1.45
|
|
Year Ended December 31, 2007
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
2.72
|
|
|
$
|
1.44
|
|
Second Quarter
|
|
|
4.10
|
|
|
|
1.50
|
|
Third Quarter
|
|
|
2.54
|
|
|
|
1.66
|
|
Fourth Quarter
|
|
|
2.70
|
|
|
|
1.20
|
|
Year Ended December 31, 2008
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
1.45
|
|
|
$
|
0.67
|
|
Second Quarter
|
|
|
0.72
|
|
|
|
0.26
|
|
Third Quarter (through September 29, 2008)
|
|
|
0.42
|
|
|
|
0.12
|
|
On April 30, 2008, the last day prior to the public
announcement of the proposed merger, the closing price per share
of Critical Therapeutics common stock as reported on The
NASDAQ Global Market was $0.62, for an aggregate market value of
Critical Therapeutics of approximately $26,957,103. Accordingly,
if the merger had been consummated on that day, the value
attributable to the shares of Critical Therapeutics common
stock issued to holders of Cornerstones common stock and
issuable to holders of Cornerstones outstanding options
and warrants in connection with the merger would have been
approximately $62.9 million, based on approximately
101.5 million shares of Critical Therapeutics
common stock issued or issuable to Cornerstones
stockholders in the merger, multiplied by $0.62.
On September 29, 2008, the last practicable date before the
printing of this proxy statement/prospectus, the closing price
per share of Critical Therapeutics common stock as
reported on The NASDAQ Capital Market was $0.17, for an
aggregate market value of Critical Therapeutics of approximately
$7.4 million. Accordingly, if the merger had been consummated on
that day, the value attributable to the shares of Critical
Therapeutics common stock issued to holders of
Cornerstones common stock and issuable to holders of
Cornerstones outstanding options and warrants in
connection with the merger would have been approximately $17.2
million, based on approximately 101.5 million shares of
Critical Therapeutics common stock issued or issuable to
Cornerstones stockholders in the merger multiplied by
$0.17.
Because the market price of Critical Therapeutics common
stock is subject to fluctuation, the market value of the shares
of Critical Therapeutics common stock that holders of
Cornerstones common stock and Cornerstones
outstanding stock options and warrants will be entitled to
receive in the merger may increase or decrease.
22
Following the consummation of the merger, and subject to
successful application for initial listing with The NASDAQ
Capital Market, Critical Therapeutics common stock will
continue to be listed on The NASDAQ Capital Market. Although
Critical Therapeutics common stock will continue with the
trading symbol CRTX, it will trade under the
combined companys new name, Cornerstone Therapeutics
Inc. There has never been, nor is there expected to be in
the future, a public market for Cornerstones common stock.
As of September 29, 2008, Critical Therapeutics had
approximately 76 stockholders of record.
Critical Therapeutics has never declared or paid cash dividends
on its capital stock. Critical Therapeutics currently intends to
retain earnings, if any, to finance the growth and development
of its business, and does not expect to pay any cash dividends
to its stockholders in the foreseeable future. Payment of future
dividends, if any, will be at the discretion of Critical
Therapeutics board of directors.
23
RISK
FACTORS
In addition to the other information contained in this proxy
statement/prospectus, you should carefully consider the risks
and uncertainties described below.
Risks
Related to the Merger
Some
of Critical Therapeutics and Cornerstones officers
and directors have interests that may be different from yours
and influence them to support or approve the
merger.
Officers and directors of Critical Therapeutics and Cornerstone
participate in arrangements that provide them with interests in
the merger that are different from yours, including, among
others, their continued service as an officer or director of the
combined company, retention and severance benefits, the
acceleration of restricted stock and stock option vesting and
continued indemnification.
For example, pursuant to the terms of employment agreements with
Critical Therapeutics executive officers and a
change of control cash bonus program established by
Critical Therapeutics, upon the consummation of the merger, the
executive officers of Critical Therapeutics are entitled to
receive aggregate cash payments of approximately $305,000 and
accelerated vesting of restricted stock with an aggregate value
of approximately $16,978, assuming that the merger had been
consummated on September 15, 2008. Assuming each executive
officer of Critical Therapeutics is terminated other than for
cause or terminates his employment for good
reason, in each case as those terms are defined in his
employment agreement, within specified periods before or after
the consummation of the merger, then the executive officers of
Critical Therapeutics would be entitled to receive aggregate
cash payments of approximately $1,814,318 accelerated vesting of
restricted stock with an aggregate value of approximately
$33,956 and additional aggregate payments of approximately
$88,150 for COBRA premiums for continued health and dental
coverage, premiums for life insurance and disability insurance
and outplacement services, assuming that the merger had been
consummated on September 15, 2008. Although the executive
officers and directors of Critical Therapeutics are entitled to
accelerated vesting of unvested stock options in connection with
the merger, all stock options subject to accelerated vesting
have an exercise price that is greater than $0.22 per share, the
closing market price of Critical Therapeutics common stock
on September 15, 2008. Unvested stock options held by
executive officers and directors of Critical Therapeutics that
are subject to accelerated vesting have exercise prices ranging
from $1.05 to $8.58 per share and a weighted average exercise
price of $3.32 per share. Following the effective time of the
merger, the executive management team of the combined company is
expected to be composed primarily of current Cornerstone
executives. It is not expected that any of the current executive
officers or directors of Critical Therapeutics will continue his
or her service with the combined company following the
merger, other than Scott B. Townsend, Critical
Therapeutics General Counsel, Senior Vice President of
Legal Affairs and Secretary.
In anticipation of Mr. Townsends service to the
combined company following the merger, on September 16,
2008, Critical Therapeutics entered into an amendment to the
amended and restated employment agreement between Critical
Therapeutics and Mr. Townsend. This amendment will be
effective from the effective time of the merger to
December 31, 2010 and will only become effective if the
merger is consummated. Under the terms of this amendment,
Mr. Townsend will serve as the General Counsel, Executive
Vice President of Legal Affairs and Secretary of the combined
company. The amendment provides for an increase in
Mr. Townsends annual target cash bonus as a
percentage of base salary from 30% to 35% and an actual annual
cash bonus for Mr. Townsend for 2008 of not less than 35%
of his base salary if he remains an employee in good standing
through December 31, 2008. Mr. Townsend will continue
to receive an annual base salary of $275,000. In connection with
such amendment, Critical Therapeutics also entered into a
restricted stock agreement with Mr. Townsend that provides
for a restricted stock grant to Mr. Townsend on the first
business day after the consummation of the merger of a number of
shares of common stock representing one percent of the combined
companys outstanding equity, on a fully diluted basis but
excluding an aggregate of 7,208,707 shares of Critical
Therapeutics common stock underlying warrants issued in
connection with a June 2005 private placement and an
October 2006 registered offering, after giving effect to the
reverse stock split and the merger, subject to the terms of such
restricted stock agreement. The restricted stock agreement will
only become effective if the merger is consummated. It is
expected that approximately 1,489,789 shares
24
will be issued to Mr. Townsend pursuant to the restricted
stock agreement, subject to adjustment as a result of the
reverse stock split. The amendment to Mr. Townsends
amended and restated employment agreement also provides for
additional potential future benefits to Mr. Townsend in
connection with a termination of his employment by the combined
company other than for cause or by Mr. Townsend for good
reason.
Cornerstones executive officers are expected to continue
as executive officers of the combined company with initial
annual base salaries following the merger that are identical to
their respective annual base salaries with Cornerstone
immediately prior to the merger. These individuals, their
expected positions and annual base salaries with the combined
company are as follows:
|
|
|
|
|
Craig A. Collard, President and Chief Executive Officer, annual
base salary of $379,600;
|
|
|
|
Chenyqua Baldwin, Vice President, Finance, Chief Accounting
Officer and Controller, annual base salary of $223,600;
|
|
|
|
Brian Dickson, M.D., Chief Medical Officer, annual base
salary of $270,400;
|
|
|
|
George Esgro, Vice President, Sales and Marketing, annual base
salary of $220,000;
|
|
|
|
Steven M. Lutz, Executive Vice President, Manufacturing and
Trade, annual base salary of $250,000; and
|
|
|
|
David Price, Executive Vice President, Finance, and Chief
Financial Officer, annual base salary of $285,000.
|
As of May 2, 2008, the date that holders of a majority of
the shares of Cornerstones outstanding common stock acting
by written consent without a meeting in accordance with
Section 228 of the Delaware General Corporation Law and
Cornerstones bylaws approved the merger agreement and the
transactions contemplated thereby, Mr. Collard controlled,
directly or indirectly, 54% of the outstanding shares of
Cornerstones common stock, and Cornerstones
executive officers and directors, and their affiliates, in the
aggregate controlled, directly or indirectly, 68.3% of the
outstanding shares of Cornerstones common stock.
Assuming that the merger had been consummated on
September 15, 2008, Cornerstones executive officers
and directors, and their affiliates, would beneficially own, in
the aggregate, 67,523,206 shares, or approximately 51%, of
the outstanding common stock of the combined company, including
any shares of the common stock of the combined company issuable
in the merger in exchange for shares of Cornerstones
outstanding common stock to be issued to Carolina
Pharmaceuticals upon the exchange or conversion of principal
amounts under the Carolina Note into shares of
Cornerstones common stock prior to the effective time of
the merger pursuant to the noteholder agreement between Carolina
Pharmaceuticals and Critical Therapeutics. Additionally,
Cornerstones executive officers and directors would hold
options to acquire an aggregate of 6,409,119 shares of the
common stock of the combined company that are not considered
beneficially owned because such options are not exercisable
within sixty days of September 15, 2008.
Carolina Pharmaceuticals, which is the holder of the Carolina
Note, has entered into an agreement with Critical Therapeutics
that provides, among other things, for the exchange or
conversion of the outstanding principal amount of the Carolina
Note into shares of Cornerstones common stock outstanding
immediately prior to the effective time of the merger.
Mr. Collard is the Chief Executive Officer and Chairman of
the Board of Carolina Pharmaceuticals.
These interests, among others, may influence the officers and
directors of Critical Therapeutics and Cornerstone to support or
approve the merger. For a more detailed discussion, see
The Merger Interests of Critical
Therapeutics Directors and Executive Officers in the
Merger and The Merger Interests of
Cornerstones Directors and Executive Officers in the
Merger beginning on pages 119 and 125,
respectively, of this proxy statement/prospectus.
The
merger may be completed even though material adverse changes may
result from the announcement of the merger, industry-wide
changes and other causes.
In general, either party can refuse to complete the merger if
there is a material adverse change affecting the other party
between May 1, 2008, the date of the merger agreement, and
the closing. However, some types of
25
changes do not permit either party to refuse to complete the
merger, even if such changes would have a material adverse
effect on Critical Therapeutics or Cornerstone, to the extent
they resulted from the following and do not have a materially
disproportionate effect on Critical Therapeutics or Cornerstone,
as the case may be:
|
|
|
|
|
changes in prevailing economic or market conditions in the
United States or any other jurisdiction in which a party has
substantial business operations;
|
|
|
|
changes or events affecting the industries in which the parties
operate generally;
|
|
|
|
changes in generally accepted accounting principles or
requirements applicable to a party;
|
|
|
|
changes in laws, rules or regulations of general applicability
or interpretations thereof;
|
|
|
|
changes caused by the execution, delivery and performance of the
merger agreement and the transactions contemplated thereby;
|
|
|
|
changes caused by any outbreak of major hostilities in which the
United States is involved or any act of terrorism within the
United States or directed against facilities or citizens of the
United States; or
|
|
|
|
with respect to Critical Therapeutics, specified ordinary course
operational exceptions as set forth in Critical
Therapeutics disclosure schedules.
|
In addition, if a material adverse change occurs between
May 1, 2008 and the closing that affects one party, and
assuming that all other closing conditions have been satisfied,
the other party may, to the extent consistent with such
partys obligations under Delaware and federal disclosure
and securities laws, elect to complete the merger without
seeking further stockholder approval, notwithstanding the
material adverse change.
If adverse changes occur but Critical Therapeutics and
Cornerstone must still complete the merger, the combined
companys stock price may suffer.
The
market price of Critical Therapeutics common stock has
fallen significantly since the public announcement of the
proposed merger. If the merger is completed and the perceived
benefits of the merger are not realized, the market price of the
combined companys common stock may decline
further.
On April 30, 2008, the last day prior to the public
announcement of the proposed merger, the closing price per share
of Critical Therapeutics common stock as reported on The
NASDAQ Global Market was $0.62. On September 29, 2008, the
last practicable date before the printing of this proxy
statement/prospectus, the closing price per share of Critical
Therapeutics common stock as reported on The NASDAQ
Capital Market was $0.17, which represents an
approximately 73% decrease from the closing price on
April 30, 2008. If the merger is completed, the market
price of the combined companys common stock may decline
further for a number of reasons, including if:
|
|
|
|
|
the combined company does not achieve the perceived benefits of
the merger as rapidly or to the extent anticipated by financial
or industry analysts;
|
|
|
|
the effect of the merger on the combined companys business
and prospects is not consistent with the expectations of
financial or industry analysts; or
|
|
|
|
investors react negatively to the effect on the combined
companys business and prospects from the merger.
|
Critical
Therapeutics and Cornerstones stockholders may not
realize a benefit from the merger commensurate with the
ownership dilution they will experience in connection with the
merger.
It is anticipated that, immediately following the completion of
the merger, Critical Therapeutics stockholders, who prior
to the closing of the merger own 100% of Critical
Therapeutics common stock, will own approximately 30% of
the common stock of the combined company and Cornerstones
security holders, who prior to the closing of the merger own
100% of the fully diluted common stock of Cornerstone, will own
approximately 70% of the common stock of the combined company,
assuming the exchange or conversion prior to the merger of the
outstanding principal amount of the Carolina Note into shares of
Cornerstones
26
common stock and after giving effect to shares issuable pursuant
to Cornerstones outstanding options and warrants, but
without giving effect to any shares issuable pursuant to
Critical Therapeutics outstanding options and warrants.
Accordingly, if the combined company is unable to realize the
strategic and financial benefits currently anticipated from the
merger, Critical Therapeutics and Cornerstones
stockholders will have experienced substantial dilution of their
ownership interest without receiving any commensurate benefit.
For example, had the merger been consummated as of June 30,
2008 and assuming the net income of the combined company was
comprised solely of the net income attributable to Cornerstone,
the dilution of the ownership interest of Cornerstones
stockholders would have resulted in Cornerstones earnings
per share decreasing from $0.10 to $0.07 for the six months
ended June 30, 2008.
During
the pendency of the merger, Critical Therapeutics and
Cornerstone may not be able to enter into a business combination
with another party because of restrictions in the merger
agreement.
Covenants in the merger agreement impede the ability of Critical
Therapeutics or Cornerstone to make acquisitions or complete
other transactions that are not in the ordinary course of
business pending completion of the merger. While the merger
agreement is in effect and subject to limited exceptions, each
party is prohibited from soliciting, initiating, encouraging or
taking actions designed to facilitate any inquiries or the
making of any proposal or offer that could lead to the entering
into certain extraordinary transactions with any third party,
such as a sale of assets, an acquisition of Critical
Therapeutics common stock, a tender offer for Critical
Therapeutics common stock, a merger or other business
combination outside the ordinary course of business. Any such
transactions could be favorable to such partys
stockholders.
Negative
perceptions regarding the pending merger may harm either
Critical Therapeutics or Cornerstones business and
employee relationships.
During the pendency of the merger, uncertainty or negative
perceptions regarding the merger or the combined companys
business and prospects could harm relationships that either
Critical Therapeutics or Cornerstone has established as an
independent, standalone company. For example:
|
|
|
|
|
Suppliers, distributors and other business partners may seek to
change or terminate their relationships with either Critical
Therapeutics or Cornerstone as a result of the proposed merger.
|
|
|
|
As a result of the proposed merger, current and prospective
employees could experience uncertainty about their future roles
within the combined company. This uncertainty may adversely
affect the ability of either Critical Therapeutics or
Cornerstone to retain its key employees, who may seek other
employment opportunities.
|
In addition, during the pendency of the merger, the management
team of either Critical Therapeutics or Cornerstone may be
distracted from day to day operations as a result of the
proposed merger.
Because
the lack of a public market for the Cornerstone shares makes it
difficult to evaluate the fairness of the merger,
Cornerstone stockholders may receive consideration in the
merger that is greater than or less than the fair market value
of the Cornerstone shares.
The outstanding capital stock of Cornerstone is privately held
and is not traded in any public market. The lack of a public
market makes it extremely difficult to determine the fair market
value of Cornerstone. Since the percentage of Critical
Therapeutics equity to be issued to Cornerstones
stockholders was determined based on negotiations between the
parties, it is possible that the value of the Critical
Therapeutics common stock to be issued in connection with
the merger will be greater than the fair market value of
Cornerstone. Alternatively, it is possible that the value of the
shares of Critical Therapeutics common stock to be issued
in connection with the merger will be less than the fair market
value of Cornerstone.
27
If any
of the events described in Risks Related to
Cornerstone occur, those events could cause the potential
benefits of the merger not to be realized.
Following the effective time of the merger, current Cornerstone
officers and directors will direct the business and operations
of the combined company. Additionally, Cornerstones
business is expected to constitute most, if not all, of the
business of the combined company following the merger. As a
result, the risks described below in the section entitled
Risks Related to Cornerstone beginning on
page 59 are among the most significant risks to the
combined company if the merger is completed. To the extent any
of the events in the risks described below in the section
entitled Risks Related to Cornerstone beginning on
page 59 occur, those events could cause the potential
benefits of the merger not to be realized and the market price
of the combined companys common stock to decline.
Risks
Related to Critical Therapeutics
Risks
Relating to Critical Therapeutics Business
Critical
Therapeutics business depends heavily on the commercial
success of ZYFLO CR.
ZYFLO CR and ZYFLO are currently Critical Therapeutics
only commercially marketed products. Critical Therapeutics
commercially launched ZYFLO CR on September 27, 2007. In
February 2008, Critical Therapeutics discontinued the production
and supply of ZYFLO, which Critical Therapeutics had
commercially launched in October 2005, but Critical Therapeutics
resumed the supply of ZYFLO in September 2008 to help
manage the potential impact to patients of supply chain issues
for ZYFLO CR. In the six months ended June 30, 2008,
Critical Therapeutics experienced supply chain issues in
manufacturing ZYFLO CR and recorded an inventory reserve for an
aggregate of 12 batches of ZYFLO CR that could not be released
into Critical Therapeutics supply chain. If Critical
Therapeutics is unable to manufacture or release ZYFLO CR on a
timely and consistent basis, some physicians may prescribe ZYFLO
to ensure that their patients with asthma continue to have
access to zileuton as a treatment option. ZYFLO, which is dosed
four times per day, contains the same zileuton active
pharmaceutical ingredient, or API, as ZYFLO CR, which is dosed
two tablets twice daily. When prescribed as indicated in their
respective labels, both ZYFLO CR and ZYFLO provide a patient
with 2,400 mg of zileuton per day. Both ZYFLO CR and ZYFLO
are approved by the FDA for the same indication.
ZYFLO has not achieved broad market acceptance. If Critical
Therapeutics is able to successfully commercialize
ZYFLO CR, Critical Therapeutics expects it will account for
a significant portion of Critical Therapeutics revenues
for the foreseeable future. However, Critical Therapeutics
cannot assure you that ZYFLO CR will not suffer the same lack of
broad market acceptance that has affected ZYFLO.
Critical Therapeutics product candidates are in early
clinical and preclinical stages of development and are a number
of years away from commercialization. Research and development
of product candidates is a lengthy and expensive process.
Critical Therapeutics early-stage product candidates in
particular will require substantial funding for Critical
Therapeutics to complete preclinical testing and clinical
trials, initiate manufacturing and, if approved for sale,
initiate commercialization. If ZYFLO CR is not commercially
successful, Critical Therapeutics may be forced to find
additional sources of funding earlier than Critical Therapeutics
anticipated. If Critical Therapeutics is not successful in
obtaining additional funding on acceptable terms, Critical
Therapeutics may be forced to significantly delay, limit or
eliminate one or more of Critical Therapeutics development
or commercialization programs.
If
ZYFLO CR does not achieve market acceptance, Critical
Therapeutics may not be able to generate significant revenues
unless Critical Therapeutics is able to successfully develop and
commercialize other product candidates.
The commercial success of ZYFLO CR will depend upon its
acceptance by the medical community, third-party payors and
patients. Physicians will prescribe ZYFLO CR only if they
determine, based on experience, clinical data, side effect
profiles or other factors, that this product either alone or in
combination with other
28
products is appropriate for managing asthma. Critical
Therapeutics believes that the primary advantage of ZYFLO CR
over ZYFLO is ZYFLO CRs more convenient dosing schedule,
but this advantage may not result in broad market acceptance of
ZYFLO CR, and Critical Therapeutics may experience the same lack
of market acceptance with ZYFLO CR that Critical Therapeutics
has experienced with ZYFLO.
Despite being approved by the FDA since 1996, ZYFLO did not
achieve broad market acceptance. During the period between
Critical Therapeutics commercial launch of ZYFLO in
October 2005 through May 2008, prescription data for ZYFLO
indicates that approximately 5,900 physicians prescribed the
product. Critical Therapeutics recorded revenue from the sale of
ZYFLO of $8.7 million for the year ended December 31,
2007 and $748,000 for the six months ended June 30, 2008.
Critical Therapeutics recorded revenue from the sale of ZYFLO CR
of $2.3 million for the year ended December 31, 2007
and $6.5 million for the six months ended June 30,
2008. Critical Therapeutics experienced difficulty expanding the
prescriber and patient bases for ZYFLO, in part, Critical
Therapeutics believes, because some physicians view ZYFLO
as less effective than other products on the market or view its
clinical data as outdated and because it requires dosing of one
tablet four times per day, which some physicians and patients
may find inconvenient or difficult to comply with compared to
other available asthma therapies that require dosing only once
or twice daily. In addition, if physicians do not prescribe
ZYFLO CR for the recommended dosing regimen of two tablets twice
daily, or if patients do not comply with the dosing schedule and
take less than the prescribed number of tablets, Critical
Therapeutics sales of ZYFLO CR will be limited and
Critical Therapeutics revenues will be adversely affected.
The position of ZYFLO CR in managed care formularies, which are
lists of approved products developed by managed care
organizations, or MCOs, may make it more difficult to expand the
current market share for this product. In most instances, ZYFLO
CR and ZYFLO have been placed in formulary positions that
require a higher co-payment for patients. In some cases, MCOs
may require additional evidence that a patient had previously
failed another therapy, additional paperwork or prior
authorization from the MCO before approving reimbursement for
ZYFLO CR.
If any existing negative perceptions about ZYFLO persist,
Critical Therapeutics will have difficulty achieving market
acceptance for ZYFLO CR. If Critical Therapeutics is unable to
achieve market acceptance of ZYFLO CR, Critical
Therapeutics will not generate significant revenues unless
Critical Therapeutics is able to successfully develop and
commercialize other product candidates.
Concerns
regarding the safety profile of ZYFLO CR may limit market
acceptance of ZYFLO CR, and, if significant adverse events
related to ZYFLO CR occur, Critical Therapeutics may be exposed
to product liability claims.
Market perceptions about the safety of ZYFLO also may limit the
market acceptance of ZYFLO CR. In the clinical trials that were
reviewed by the FDA prior to its approval of ZYFLO, 3.2% of the
approximately 5,000 patients who received ZYFLO experienced
increased levels of a liver enzyme called alanine transaminase,
or ALT, of over three times the levels normally seen in the
bloodstream. In these trials, one patient developed symptomatic
hepatitis with jaundice, which resolved upon discontinuation of
therapy, and three patients developed mild elevations in
bilirubin. In clinical trials for ZYFLO CR, 1.94% of the
patients taking ZYFLO CR in a three-month efficacy trial
and 2.6% of the patients taking ZYFLO CR in a six-month safety
trial experienced ALT levels greater than or equal to three
times the level normally seen in the bloodstream. Because ZYFLO
CR can elevate liver enzyme levels, periodic liver function
tests are recommended for patients taking ZYFLO CR, based upon
its product label, which was approved by the FDA in May 2007.
Some physicians and patients may perceive liver function tests
as inconvenient or indicative of safety issues, which could make
them reluctant to prescribe or accept ZYFLO CR and any other
zileuton product candidates that Critical Therapeutics
successfully develops and commercializes. As a result, many
physicians may have negative perceptions about the safety of
ZYFLO CR and other zileuton product candidates, which could
limit their commercial acceptance. The absence of ZYFLO from the
market prior to Critical Therapeutics commercial launch in
October 2005 may have exacerbated any negative perceptions
about ZYFLO if
29
physicians believe the absence of ZYFLO from the market was
related to safety or efficacy issues. These negative perceptions
could carry over to ZYFLO CR.
In March 2008, the FDA issued an early communication regarding
an ongoing safety review of the leukotriene montelukast relating
to suicide and other behavior related adverse events. In that
communication, the FDA stated that it was also reviewing the
safety of other leukotriene medications. On May 27, 2008,
Critical Therapeutics received a request from the FDA that
Critical Therapeutics gather and provide to the FDA data from
its clinical trial database to evaluate behavior-related adverse
events for ZYFLO and ZYFLO CR. Depending on the results of such
analyses and the FDAs review, the FDA could request that
Critical Therapeutics revise the labeling of ZYFLO and ZYFLO CR
to include statements regarding the potential for suicidal
thoughts or other behavior-related changes associated with the
use of zileuton. If the FDA requests that Critical Therapeutics
add these statements or similar statements to its package
inserts, sales of these products could suffer.
If the use of ZYFLO CR or ZYFLO harms people, Critical
Therapeutics may be subject to costly and damaging product
liability claims. Critical Therapeutics currently has products
liability insurance coverage with a $20.0 million annual
aggregate limit and a $20.0 million individual claim limit,
which is subject to a per claim deductible and a policy
aggregate deductible. This product liability insurance covers
both product liability claims for ZYFLO CR and ZYFLO and
clinical trial liability claims for Critical Therapeutics
product candidates. The annual cost of this products liability
insurance was approximately $400,000 for the policy year
starting October 29, 2007. This insurance policy may not
provide adequate coverage against potential liabilities.
Furthermore, product liability and clinical trial insurance is
becoming increasingly expensive. As a result, Critical
Therapeutics may be unable to maintain current amounts of
insurance coverage, obtain additional insurance or obtain
sufficient insurance at a reasonable cost to protect against
losses that Critical Therapeutics has not anticipated in its
business plans. Any product liability claim against Critical
Therapeutics, even if Critical Therapeutics successfully defends
against it, could cause Critical Therapeutics to incur
significant legal expenses, divert Critical Therapeutics
managements attention and harm Critical Therapeutics
reputation.
If
Critical Therapeutics marketing and sales infrastructure
and presence are not adequate or Critical Therapeutics
collaborative marketing arrangements are not successful,
Critical Therapeutics ability to market and sell its
products will be impaired.
After increasing the size of Critical Therapeutics sales
force in connection with the commercial launch of ZYFLO CR to
approximately 42 sales representatives in October 2007, Critical
Therapeutics decreased the size of its sales force to
approximately 29 sales representatives as of June 30, 2008.
Building Critical Therapeutics sales force involved
significant time and expense. If Critical Therapeutics is not
successful in its efforts to retain an adequate sales force, its
ability to market and sell ZYFLO CR will be impaired.
In March 2007, Critical Therapeutics entered into a co-promotion
agreement with Dey, L.P., a wholly owned subsidiary of Mylan
Inc., or DEY, for the co-promotion of ZYFLO CR and ZYFLO.
Critical Therapeutics cannot predict whether the co-promotion
arrangement will lead to increased sales for ZYFLO CR. DEY
initiated promotional detailing activities for ZYFLO CR on
September 27, 2007 and for ZYFLO on April 30, 2007.
Given the recent initiation of DEYs efforts, the potential
success of the co-promotion arrangement is uncertain. Under the
co-promotion agreement, Critical Therapeutics agreed to provide
a minimum number of promotional details per month by Critical
Therapeutics sales representatives to a specified group of
office-based physicians and other health care professionals for
ZYFLO CR. If Critical Therapeutics is not successful in its
efforts to provide the required level of promotional detailing,
DEYs co-promotion fee may be increased and DEY may have a
right to terminate the co-promotion agreement for ZYFLO CR. For
example, if Critical Therapeutics experiences greater than
expected turnover of sales representatives, Critical
Therapeutics may have difficulty satisfying its minimum
detailing obligations. In February 2008, Mylan Inc., or Mylan,
which acquired DEY in October 2007 as part of its acquisition of
Merck KGaAs generic business, of which DEY was a part,
announced that it is pursuing strategic alternatives for DEY,
including the potential sale of the business. Any decision by
DEY or Mylan not to devote sufficient resources to the
co-promotion arrangement or any future reductions in efforts
under the co-promotion arrangement, including as a result of the
sale or
30
potential sale of DEY by Mylan, would limit Critical
Therapeutics ability to generate significant revenues from
product sales.
On June 25, 2007, as contemplated by the terms of the
zileuton co-promotion agreement, Critical Therapeutics and DEY
entered into a separate definitive co-promotion agreement
providing for Critical Therapeutics to co-promote DEYs
product
PERFOROMISTtm
(formoterol fumarate) Inhalation Solution, or PERFOROMIST, for
the
long-term,
twice-daily maintenance treatment of bronchoconstriction for
emphysema and chronic bronchitis, which is also known as chronic
obstructive pulmonary disease, or COPD. Under the PERFOROMIST
co-promotion agreement, DEY agreed to pay Critical Therapeutics
a co-promotion fee based on retail sales of PERFOROMIST and
Critical Therapeutics agreed to provide a minimum number of
promotional details per month by Critical Therapeutics
sales representatives to a specified group of office-based
physicians and other health care professionals. Promoting both
ZYFLO CR and PERFOROMIST may be challenging for Critical
Therapeutics sales representatives and may reduce their
efficiency, which could negatively impact Critical
Therapeutics revenues.
The amount of any co-promotion fee that DEY pays to Critical
Therapeutics under the PERFOROMIST
co-promotion
agreement will be limited if PERFOROMIST does not achieve market
acceptance. For example, safety concerns relating to PERFOROMIST
may harm potential sales. PERFOROMIST belongs to a class of
medications known as long-acting beta2-adrenergic agonists, or
LABAs, which may increase the risk of
asthma-related
death. Data from a large placebo-controlled study in the United
States comparing the safety of the LABA salmeterol or placebo
plus usual asthma therapy showed an increase in asthma-related
deaths in patients receiving salmeterol. This finding also may
apply to formoterol, the active ingredient in PERFOROMIST. For
the year ended December 31, 2007 and the six months ended
June 30, 2008, Critical Therapeutics did not receive any
co-promotion fees from DEY in connection with the PERFOROMIST
co-promotion agreement because the level of quarterly retail
sales for PERFOROMIST did not exceed a specified level. On
July 2, 2008, Critical Therapeutics provided notice to DEY
that Critical Therapeutics had exercised its contractual right
to terminate the co-promotion agreement for PERFOROMIST. The
termination is effective September 30, 2008.
A
failure to maintain appropriate inventory levels could harm
Critical Therapeutics reputation and subject Critical
Therapeutics to financial losses.
Critical Therapeutics is subject to minimum purchase obligations
under its supply agreements with its third-party manufacturers,
which require Critical Therapeutics to buy inventory of the
zileuton API and tablet cores for ZYFLO CR. Critical
Therapeutics has committed to purchase a minimum amount of
zileuton API from Shasun of $2.0 million in 2008 and
$2.0 million in 2009, although Critical Therapeutics has
the right to reduce by $1.3 million the amount of zileuton
API it must purchase in 2009 by providing written notice to
Shasun no later than December 31, 2008. The API purchased
from Shasun currently has a shelf-life of 36 months. In
addition, Critical Therapeutics has committed to purchase a
minimum of 20 million ZYFLO CR tablet cores from Jagotec in
each of the four
12-month
periods starting May 30, 2008. If ZYFLO CR does not achieve
the level of demand Critical Therapeutics anticipates, Critical
Therapeutics may not be able to use the inventory it is required
to purchase. As of June 30, 2008, Critical Therapeutics had
$7.8 million in inventory, consisting primarily of tablet
cores and API. Based on Critical Therapeutics current
expectations regarding demand for ZYFLO CR, Critical
Therapeutics expects that its inventory levels could increase
substantially in the future as a result of its minimum purchase
obligations under its supply agreements with third-party
manufacturers and orders it has submitted to date. Significant
differences between Critical Therapeutics current
estimates and judgments and future estimated demand for its
products and the useful life of inventory may result in
significant charges for excess inventory or purchase commitments
in the future. If Critical Therapeutics is required to recognize
charges for excess inventories, it could have a material adverse
effect on Critical Therapeutics financial condition and
results of operations in the period in which Critical
Therapeutics recognizes charges for excess inventory.
In the six months ended June 30, 2008, Critical
Therapeutics recorded an inventory reserve for an aggregate of
12 batches of ZYFLO CR that could not be released into Critical
Therapeutics commercial supply chain, consisting of five
batches that did not meet Critical Therapeutics product
release specifications and seven additional batches that were on
quality assurance hold and that could not complete manufacturing
within the
31
manufacturing timelines specified pursuant to the new drug
application, or NDA, for ZYFLO CR. Critical Therapeutics cannot
assure you that it will not have similar manufacturing issues in
producing ZYFLO CR in the future. If Critical Therapeutics is
unable to manufacture or release ZYFLO CR on a timely and
consistent basis, if Critical Therapeutics fails to maintain an
adequate inventory of zileuton API or ZYFLO CR core tablets, if
Critical Therapeutics inventory were to be destroyed or
damaged, or if Critical Therapeutics inventory were to
reach its expiration date, patients might not have access to
ZYFLO CR, Critical Therapeutics reputation and its brand
could be harmed and physicians may be less likely to prescribe
ZYFLO CR in the future. Conversely, if Critical Therapeutics is
unable to sell Critical Therapeutics inventory in a timely
manner, Critical Therapeutics could experience cash flow
difficulties and additional financial losses.
Critical
Therapeutics faces substantial competition. If Critical
Therapeutics is unable to compete effectively, ZYFLO CR, ZYFLO
and Critical Therapeutics product candidates may be
rendered noncompetitive or obsolete.
The development and commercialization of new drugs is highly
competitive. Critical Therapeutics will face competition with
respect to the development of product candidates and for ZYFLO
CR, ZYFLO and any other products that Critical Therapeutics
commercializes in the future from pharmaceutical companies,
biotechnology companies, specialty pharmaceutical companies,
companies selling low-cost generic substitutes, academic
institutions, government agencies and research institutions.
A number of large pharmaceutical and biotechnology companies
currently market and sell products to treat asthma that compete
with ZYFLO CR and ZYFLO. Many established therapies currently
command large market shares in the asthma market, including
Merck & Co., Inc.s
Singulair®,
GlaxoSmithKline plcs
Advair®
and inhaled corticosteroid products. In addition, Critical
Therapeutics may face competition from pharmaceutical companies
seeking to develop new drugs for the asthma market. For example,
in June 2007, AstraZeneca PLC commercially launched in the
United States
Symbicort®,
a twice-daily asthma therapy combining budesonide, an inhaled
corticosteroid, and formoterol, a long-acting beta2-agonist.
In the COPD market, zileuton, if Critical Therapeutics is able
to develop it as a treatment for COPD, will face intense
competition. COPD patients are currently treated primarily with
a number of medications that are indicated for COPD, asthma or
both COPD and asthma. The primary products used to treat COPD
are anticholinergics, long-acting beta-agonists and combination
long-acting beta-agonists and inhaled corticosteroids. These
medications are delivered in various device formulations,
including metered dose inhalers, dry powder inhalers and by
nebulization. Lung reduction surgery is also an option for
COPD patients.
Many therapies for COPD are already well established in the
respiratory marketplace, including GlaxoSmithKlines
Advair®
and
Serevent®
and
Spiriva®,
a once-daily muscarinic antagonist from Boehringer Ingleheim
GmbH and Pfizer. Other novel approaches are also in development.
Critical Therapeutics is also developing zileuton injection for
use in the hospital emergency department for the treatment of
acute asthma attacks. Critical Therapeutics may face intense
competition from companies seeking to develop new drugs for use
in severe acute asthma attacks. For example, Merck &
Co., Inc. has conducted clinical trials of an intravenous
formulation of its product
Singulair®.
If Critical Therapeutics therapeutic programs directed
toward the bodys inflammatory response result in
commercial products, such products will compete predominantly
with therapies that have been approved for diseases such as
rheumatoid arthritis, like Amgen, Inc.s
Enbrel®,
Johnson & Johnsons
Remicade®,
Bristol-Myers
Squibb Companys
Orencia®,
Abbott Laboratories
Humira®
and
Rituxan®
marketed by Biogen Idec Inc. and Genentech, Inc., and diseases
such as sepsis, like Eli Lilly and Companys
Xigris®.
Other companies are developing therapies directed towards
cytokines. Critical Therapeutics does not know whether any or
all of these products under development will ever reach the
market and if they do, whether they will do so before or after
Critical Therapeutics products are approved.
32
Critical Therapeutics competitors products may be
safer, more effective, more convenient or more effectively
marketed and sold, than any of Critical Therapeutics
products. Many of Critical Therapeutics competitors have:
|
|
|
|
|
significantly greater financial, technical and human resources
than Critical Therapeutics has and may be better equipped to
discover, develop, manufacture and commercialize products;
|
|
|
|
more extensive experience than Critical Therapeutics has in
conducting preclinical studies and clinical trials, obtaining
regulatory approvals and manufacturing and marketing
pharmaceutical products;
|
|
|
|
competing products that have already received regulatory
approval or are in late-stage development; and
|
|
|
|
collaborative arrangements in Critical Therapeutics target
markets with leading companies and research institutions.
|
Critical Therapeutics will face competition based on the safety
and effectiveness of Critical Therapeutics products, the
timing and scope of regulatory approvals, the availability and
cost of supply, marketing and sales capabilities, reimbursement
coverage, price, patent position and other factors. Critical
Therapeutics competitors may develop or commercialize more
effective, safer or more affordable products, or obtain more
effective patent protection, than Critical Therapeutics is able
to. Accordingly, Critical Therapeutics competitors may
commercialize products more rapidly or effectively than Critical
Therapeutics is able to, which would adversely affect Critical
Therapeutics competitive position, the likelihood that its
product candidates will achieve initial market acceptance and
its ability to generate meaningful revenues from its product
candidates. Even if Critical Therapeutics product
candidates achieve initial market acceptance, competitive
products may render its products obsolete or noncompetitive. If
Critical Therapeutics product candidates are rendered
obsolete, it may not be able to recover the expenses of
developing and commercializing those product candidates.
If
Critical Therapeutics is unable to retain key personnel and hire
additional qualified personnel, Critical Therapeutics may not be
able to achieve its goals.
Critical Therapeutics success depends in large part on its
ability to attract, retain and motivate qualified management and
commercial personnel. Critical Therapeutics is highly dependent
on the principal members of its executive management team. The
loss of the services of any one or more of the members of
Critical Therapeutics executive management team would
diminish the knowledge and experience that Critical
Therapeutics, as an organization, possesses and might
significantly delay or prevent the achievement of Critical
Therapeutics research, development or commercialization
objectives and could cause Critical Therapeutics to incur
additional costs to recruit replacement executive personnel.
Critical Therapeutics does not maintain key person life
insurance on any of the members of its executive management team.
On March 2, 2008, Frank E. Thomas resigned as Critical
Therapeutics President and Chief Executive Officer
effective March 31, 2008 and as a member of Critical
Therapeutics board of directors effective March 2,
2008. On March 4, 2008, Critical Therapeutics announced
that its board of directors appointed Trevor
Phillips, Ph.D. as President and Chief Executive Officer
effective April 1, 2008 and elected Dr. Phillips as a
member of Critical Therapeutics board of directors
effective March 4, 2008. Dr. Phillips previously had
served as Critical Therapeutics Chief Operating Officer
and Senior Vice President of Operations. In addition to
Dr. Phillips, Critical Therapeutics also depends, in
particular, on the continuing services of Thomas P. Kelly,
Critical Therapeutics Chief Financial Officer and Senior
Vice President of Finance and Corporate Development, and other
members of Critical Therapeutics executive management
team. Since June 1, 2006, Critical Therapeutics has
experienced significant turnover on its executive management
team, with five executive officers, including Mr. Thomas,
leaving Critical Therapeutics and one executive officer joining
Critical Therapeutics. If Critical Therapeutics is unsuccessful
in transitioning its smaller executive management team to
compensate for the loss of Mr. Thomas and these other
executives, the achievement of Critical Therapeutics
research, financial, development and commercialization
objectives could be significantly delayed or may not occur. In
addition, Critical Therapeutics focus on transitioning to
its new management
33
team could divert its managements attention from other
business concerns. Furthermore, if Critical Therapeutics decides
to recruit new executive personnel, Critical Therapeutics will
incur additional costs.
Recruiting and retaining qualified commercial personnel, in
addition to Critical Therapeutics executive management
team, will also be critical to Critical Therapeutics
success. Any expansion into areas and activities requiring
additional expertise, such as clinical trials, governmental
approvals, contract manufacturing and sales and marketing, will
place additional requirements on Critical Therapeutics
management, operational and financial resources. These demands
may require Critical Therapeutics to hire additional personnel
and will require Critical Therapeutics existing management
personnel to develop additional expertise. Critical Therapeutics
faces intense competition for personnel. The failure to attract
and retain personnel or to develop such expertise could delay or
halt the research, development, regulatory approval and
commercialization of Critical Therapeutics product
candidates.
Critical Therapeutics has experienced turnover in its sales and
marketing team. For example, Critical Therapeutics has
experienced an increase in the number of voluntary resignations
of its sales and marketing personnel after it publicly announced
in November 2007 that it was in the process of reviewing a range
of strategic alternatives that could result in potential changes
to its current business strategy and future operations. The
pendency of Critical Therapeutics proposed merger with
Cornerstone could have a similar effect. In June 2008, Critical
Therapeutics reduced the size of its sales force by eight sales
representatives and three sales managers. If Critical
Therapeutics is not successful in its efforts to retain its
remaining qualified sales and marketing personnel, Critical
Therapeutics ability to market and sell ZYFLO CR and
Critical Therapeutics ability to deliver Critical
Therapeutics required level of promotional detailing under
Critical Therapeutics co-promotion agreements with DEY
would be impaired.
Critical Therapeutics has also experienced turnover on its board
of directors. For example, Critical Therapeutics has had eight
directors leave its board and three directors join its board
since June 1, 2006. Critical Therapeutics currently has
four directors serving on its board. If Critical
Therapeutics board were to fail to satisfy the
requirements of relevant rules and regulations of the SEC and
NASDAQ relating to director independence or membership on board
committees, this could result in the delisting of Critical
Therapeutics common stock from NASDAQ or could adversely
affect investors confidence in Critical Therapeutics and
Critical Therapeutics ability to access the capital
markets. If Critical Therapeutics is unable to attract and
retain qualified directors, the achievement of Critical
Therapeutics corporate objectives could be significantly
delayed or may not occur.
Critical
Therapeutics identified a material weakness in its internal
control over financial reporting for the second quarter and
third quarter of 2007. If Critical Therapeutics fails to achieve
and maintain effective internal control over financial
reporting, Critical Therapeutics could face difficulties in
preparing timely and accurate financial reports, which could
result in a loss of investor confidence in Critical
Therapeutics reported results and a decline in Critical
Therapeutics stock price.
In connection with the preparation of Critical
Therapeutics financial statements for the second quarter
of 2007, Critical Therapeutics identified a material weakness in
its internal control over financial reporting. This material
weakness related to the operation of controls over accounting
for non-routine transactions, specifically the accrual of
milestone obligations due under certain of Critical
Therapeutics contractual arrangements in accordance with
GAAP. As a result of this material weakness, a material
adjustment was recorded to Critical Therapeutics draft
interim financial statements after the financial close of the
second quarter of 2007. While Critical Therapeutics
internal disclosure controls and procedures detected the need to
accrue for the milestone obligations, Critical Therapeutics did
not initially reach the appropriate conclusion relative to the
timing of the accrual recognition. As a result of this material
weakness, Critical Therapeutics management concluded that
Critical Therapeutics disclosure controls and procedures
were not effective as of either June 30, 2007 or
September 30, 2007. Critical Therapeutics implemented steps
to remedy the material weakness, and Critical Therapeutics
management provided an unqualified assessment of Critical
Therapeutics internal control over financial reporting as
of December 31, 2007. There were no material changes in
Critical Therapeutics internal control over financial
reporting for the quarter ended June 30, 2008. Any failure
or difficulties in maintaining these procedures and controls
could cause Critical Therapeutics to fail to meet its periodic
reporting
34
obligations or result in its inability to prevent or detect
material misstatements in its financial statements. It is
possible that Critical Therapeutics management may not be
able to provide an unqualified assessment of Critical
Therapeutics internal control over financial reporting or
disclosure controls and procedures in the future, or be able to
provide quarterly certifications that Critical
Therapeutics disclosure controls and procedures are
effective. It is also possible that Critical Therapeutics may
identify additional significant deficiencies or material
weaknesses in Critical Therapeutics internal control over
financial reporting in the future. Any material weakness, or any
remediation thereof that is ultimately unsuccessful, could cause
investors to lose confidence in the accuracy and completeness of
Critical Therapeutics financial statements, which in turn
could harm Critical Therapeutics business, lead to a
decline in Critical Therapeutics stock price and restrict
Critical Therapeutics ability to raise additional funds
needed for the growth of its business.
Risks
Relating to Critical Therapeutics Dependence on Third
Parties
Critical
Therapeutics relies on third parties to manufacture and supply
the zileuton API, ZYFLO CR, ZYFLO and Critical
Therapeutics product candidates. Critical Therapeutics
expects to continue to rely on these sole source suppliers for
these purposes and would incur significant costs to
independently develop manufacturing facilities.
Critical Therapeutics has no manufacturing facilities and
limited manufacturing experience. In order to continue to
commercialize ZYFLO CR and ZYFLO, develop product candidates,
apply for regulatory approvals and commercialize Critical
Therapeutics product candidates, Critical Therapeutics
needs to develop, contract for or otherwise arrange for the
necessary manufacturing capabilities. Critical Therapeutics
expects to continue to rely on third parties for production of
the zileuton API, commercial supplies of ZYFLO CR, commercial
supplies of ZYFLO and preclinical and clinical supplies of
Critical Therapeutics product candidates. These third
parties are currently Critical Therapeutics sole source
suppliers, and Critical Therapeutics expects to continue to rely
on them for these purposes for the foreseeable future.
Critical Therapeutics has contracted with Shasun Pharma
Solutions Ltd., or Shasun, for commercial production of the
zileuton API, subject to specified limitations, through
December 31, 2010. Zileuton API is used in Critical
Therapeutics FDA-approved oral zileuton products, ZYFLO CR
and ZYFLO, as well as in Critical Therapeutics zileuton
injection product candidate. Critical Therapeutics only
source of supply for zileuton API is Shasun, which manufactures
the zileuton API in the United Kingdom. The manufacturing
process for the zileuton API involves an exothermic reaction
that generates heat and, if not properly controlled by the
safety and protection mechanisms in place at the manufacturing
sites, could result in unintended combustion of the product. The
manufacture of the zileuton API could be disrupted or delayed if
a batch is discontinued or damaged, if the manufacturing sites
are damaged, or if local health and safety regulations require a
third-party manufacturer to implement additional safety
procedures or cease production. In addition, there is only one
qualified supplier of a chemical known as
2-ABT, which
is one of the starting materials for zileuton, and if that
manufacturer stops manufacturing
2-ABT, is
unable to manufacture
2-ABT or is
unwilling to manufacture
2-ABT on
commercially reasonable terms or at all, Shasun may be unable to
manufacture API for Critical Therapeutics.
Critical Therapeutics has contracted with Jagotec AG, or
Jagotec, a subsidiary of SkyePharma PLC, or SkyePharma, for the
manufacture of core tablets for ZYFLO CR for commercial sale.
Critical Therapeutics only source of supply for the core
tablets of ZYFLO CR is Jagotec, which manufactures them in
France. The manufacture of the core tablets for ZYFLO CR could
be disrupted or delayed if one or more batches are discontinued
or damaged or if the manufacturing site were damaged or
destroyed.
Critical Therapeutics has contracted with Patheon
Pharmaceuticals Inc., or Patheon, to coat and package the core
tablets of ZYFLO CR for commercial sale. Patheon is currently
Critical Therapeutics only source of finished ZYFLO CR
tablets. The manufacture of the finished ZYFLO CR tablets could
be disrupted or delayed if one or more batches are discontinued
or damaged or if the manufacturing site were damaged or
destroyed.
Critical Therapeutics has contracted with Patheon to manufacture
ZYFLO tablets for commercial sale. Patheon is currently Critical
Therapeutics only source of finished ZYFLO tablets. The
manufacture of the finished
35
ZYFLO tablets could be disrupted or delayed if one or more
batches are discontinued or damaged or if the manufacturing site
were damaged or destroyed.
Critical Therapeutics is dependent upon Shasun, Patheon and
Jagotec as sole providers, and will be dependent on any other
third parties who manufacture Critical Therapeutics
product candidates, to perform their obligations in a timely
manner and in accordance with applicable government regulations.
If third-party manufacturers with whom Critical Therapeutics
contracts fail to perform their obligations, Critical
Therapeutics may be adversely affected in a number of ways,
including the following:
|
|
|
|
|
Critical Therapeutics may not be able to meet commercial demands
for ZYFLO CR and ZYFLO;
|
|
|
|
Critical Therapeutics may be required to cease distribution or
issue recalls;
|
|
|
|
Critical Therapeutics may not be able to initiate or continue
clinical trials of its product candidates that are under
development; and
|
|
|
|
Critical Therapeutics may be delayed in submitting applications
for regulatory approvals for its product candidates.
|
If Shasun, Patheon or Jagotec experiences any significant
difficulties in their respective manufacturing processes for
Critical Therapeutics products, including the zileuton
API, ZYFLO CR core tablets or finished product for ZYFLO CR and
ZYFLO, Critical Therapeutics could experience significant
interruptions in the supply of ZYFLO CR and ZYFLO. Critical
Therapeutics inability to coordinate the efforts of its
third-party manufacturing partners, or the lack of capacity or
the scheduling of manufacturing sufficient for Critical
Therapeutics needs at Critical Therapeutics
third-party manufacturing partners, could impair Critical
Therapeutics ability to supply ZYFLO CR and ZYFLO at
required levels. Such an interruption could cause Critical
Therapeutics to incur substantial costs and impair Critical
Therapeutics ability to generate revenue from ZYFLO CR and
ZYFLO may be adversely affected.
The zileuton API is manufactured in the United Kingdom by
Shasun, and Critical Therapeutics either stores the zileuton API
at a Shasun warehouse or ships the zileuton API either directly
to a contract manufacturer or to a third-party warehouse. For
the manufacture of ZYFLO CR, Critical Therapeutics ships
zileuton API to France for manufacturing of core tablets by
Jagotec and Critical Therapeutics ships core tablets from France
to the United States to be coated, packaged and labeled at
Patheon. For the manufacture of ZYFLO, Critical Therapeutics
ships zileuton API to the United States to be manufactured,
packaged and labeled at Patheon. While in transit, Critical
Therapeutics zileuton API and ZYFLO CR core tablets, each
shipment of which is of significant value, could be lost or
damaged. Moreover, at any time after shipment from Shasun,
Critical Therapeutics zileuton API, which is stored in
France at Jagotec or in the United States at Patheon or at
third-party warehouse, or Critical Therapeutics ZYFLO CR
core tablets, which are stored at Patheon prior to coating and
packaging, and Critical Therapeutics finished ZYFLO CR and
ZYFLO products, which are stored at Critical Therapeutics
third-party logistics provider, Integrated Commercialization
Solutions, Inc., or ICS, could be lost or suffer damage, which
would render them unusable. Critical Therapeutics has attempted
to take appropriate risk mitigation steps and to obtain transit
insurance. However, depending on when in the process the
zileuton API, ZYFLO CR core tablets or finished product is lost
or damaged, Critical Therapeutics may have limited recourse for
recovery against its manufacturers or insurers. As a result,
Critical Therapeutics financial performance could be
impacted by any such loss or damage to its zileuton API, ZYFLO
CR core tablets or finished products.
Critical Therapeutics may not be able to enter into alternative
supply arrangements at commercially acceptable rates, if at all.
If Critical Therapeutics were required to change manufacturers
for the zileuton API, ZYFLO CR tablet cores, ZYFLO or ZYFLO CR
or coating, Critical Therapeutics would be required to verify
that the new manufacturer maintains facilities and procedures
that comply with quality standards and all applicable
regulations and guidelines, including FDA requirements and
approved NDA product specifications. In addition, Critical
Therapeutics would be required to conduct additional clinical
bioequivalence trials to demonstrate that the finished product
manufactured by the new manufacturer is equivalent to the
finished product manufactured by Critical Therapeutics
current manufacturer. Any delays associated with the
verification of a new
36
manufacturer or conducting additional clinical bioequivalence
trials could adversely affect Critical Therapeutics
production schedule or increase Critical Therapeutics
production costs.
Critical Therapeutics has not secured a long-term commercial
supply arrangement for any of its product candidates other than
the zileuton API, which is used in zileuton injection. The
manufacturing process for Critical Therapeutics product
candidates is an element of the FDA approval process. Critical
Therapeutics will need to contract with manufacturers who can
meet the FDA requirements, including current Good Manufacturing
Practices, on an ongoing basis. In addition, if Critical
Therapeutics receives the necessary regulatory approval for its
product candidates, Critical Therapeutics also expects to rely
on third parties, including Critical Therapeutics
collaborators, to produce materials required for commercial
production. Critical Therapeutics may experience difficulty in
obtaining adequate manufacturing capacity or timing for its
needs. If Critical Therapeutics is unable to obtain or maintain
contract manufacturing of these product candidates, or to do so
on commercially reasonable terms, Critical Therapeutics may not
be able to develop and commercialize its product candidates
successfully.
Difficulties
relating to the supply chain for ZYFLO CR tablets could
significantly inhibit Critical Therapeutics ability to
meet, or prevent Critical Therapeutics from meeting, commercial
demand for the product.
In the quarter ended June 30, 2008, Critical Therapeutics
recorded an inventory reserve with respect to an aggregate of
eight batches of ZYFLO CR that could not be released into
Critical Therapeutics commercial supply chain, consisting
of one batch of ZYFLO CR that did not meet Critical
Therapeutics product release specifications and an
additional seven batches of ZYFLO CR that were on quality
assurance hold and that could not complete manufacturing within
the NDA-specified manufacturing timelines. In the quarters ended
December 31, 2007 and March 31, 2008, Critical
Therapeutics recorded inventory reserves with respect to an
aggregate of eight batches of ZYFLO CR that could not be
released into Critical Therapeutics commercial supply
chain because they did not meet Critical Therapeutics
product release specifications. In conjunction with Critical
Therapeutics three third-party manufacturers for zileuton
API, tablet cores and coating and release, Critical Therapeutics
has initiated an investigation to determine the cause of this
issue, but the investigation is ongoing and is not yet complete.
Critical Therapeutics has incurred and expects to continue to
incur significant costs in connection with its investigation. To
date, the investigation has not identified a clear source of the
issue. In August and September 2008, Critical Therapeutics
released and made available for shipment to wholesale
distributors an aggregate of six batches of finished ZYFLO CR
tablets that met its product release specifications. Critical
Therapeutics is currently unable to accurately assess the timing
and quantity of future batches of ZYFLO CR, if any, that may be
released for commercial supply. If not corrected, the ongoing
supply chain difficulties could prevent Critical Therapeutics
from supplying any further product to its wholesale
distributors. Based on its current level of sales and the
release of the six batches of ZYFLO CR in August and September
2008, Critical Therapeutics estimates that wholesale
distributors and retail pharmacies will have a sufficient
inventory of ZYFLO CR to continue to provide product to patients
through the fourth quarter of 2008.
If Critical Therapeutics investigation regarding its
supply chain requires changes to its manufacturing processes or
materials in order to be able to supply sufficient levels of
ZYFLO CR to satisfy its commercial needs, the costs to
manufacture ZYFLO CR may be significantly higher than Critical
Therapeutics had anticipated. As of June 30, 2008, Critical
Therapeutics has expensed $2.5 million relating to the
aggregate of nine batches of ZYFLO CR that failed to meet
product release specifications and the seven batches of
ZYFLO CR that were on quality assurance hold and that could
not complete manufacturing within the
NDA-specified
manufacturing timelines. In addition, Critical Therapeutics
expects to incur other significant costs in connection with its
investigation. If Critical Therapeutics is not able to supply
ZYFLO CR at a commercially acceptable cost and level, Critical
Therapeutics could experience cash flow difficulties and
additional financial losses. Depending on the outcome of the
investigation, Critical Therapeutics may not be able to obtain
reimbursement from any of its third-party manufacturers for
existing or additional batches of ZYFLO CR that do not meet
Critical Therapeutics product release specifications.
37
In April 2008, Critical Therapeutics began to reinitiate
manufacture of ZYFLO in order to have a supply of ZYFLO
available to reinitiate marketing and supply of ZYFLO to the
market given the supply chain issues being experienced for ZYFLO
CR. In September 2008, Critical Therapeutics resumed
distribution of ZYFLO to help manage the potential impact to
patients of supply chain issues for ZYFLO CR. However,
reintroducing ZYFLO could be confusing for physicians and
patients, and possibly third party wholesalers and retailers. As
a result of this potential confusion relating to the
reintroduction of ZYFLO to the market and ZYFLOs less
convenient four times daily dosing regimen, Critical
Therapeutics sales of ZYFLO will likely not meet either
the level of sales of ZYFLO CR since its market launch in
September 2007 or the historical level of sales of ZYFLO prior
to the market launch of ZYFLO CR.
Under the merger agreement, it is a condition to
Cornerstones obligation to consummate the merger that
either ZYFLO CR or ZYFLO must be available and ready for
purchase by third party wholesalers or retailers during the
period prior to the closing of the merger, other than during any
period not exceeding 30 consecutive days. If the proposed merger
with Cornerstone is not consummated, Critical Therapeutics would
be subject to all of the additional risks described above under
Risks Related to the Merger.
Any
failure to manage and maintain Critical Therapeutics
distribution network could compromise sales of ZYFLO CR and
ZYFLO and harm Critical Therapeutics
business.
Critical Therapeutics relies on third parties to distribute
ZYFLO CR and ZYFLO to pharmacies. Critical Therapeutics has
contracted with ICS, a third-party logistics company, to
warehouse and distribute ZYFLO CR and ZYFLO to three primary
wholesalers, AmerisourceBergen Corporation, Cardinal Health and
McKesson Corporation, and a number of smaller wholesalers. ICS
is Critical Therapeutics exclusive supplier of commercial
distribution logistics services. The wholesalers in turn
distribute to chain and independent pharmacies. Sales to
AmerisourceBergen Corporation, Cardinal Health and McKesson
Corporation collectively accounted for at least 95% of Critical
Therapeutics annual billings for ZYFLO CR and ZYFLO during
2007. The loss of any of these wholesaler customers
accounts or a material reduction in their purchases could harm
Critical Therapeutics business, financial condition and
results of operations.
Critical Therapeutics relies on Phoenix Marketing Group LLC, or
Phoenix, to distribute product samples to Critical
Therapeutics sales representatives, who in turn distribute
samples to physicians and other prescribers who are authorized
under state law to receive and dispense samples. This
distribution network requires significant coordination with
Critical Therapeutics supply chain, sales and marketing
and finance organizations. Failure to maintain Critical
Therapeutics contracts with ICS, the wholesalers and
Phoenix, or the inability or failure of any of them to
adequately perform as agreed under their respective contracts
with Critical Therapeutics, could negatively impact Critical
Therapeutics. Critical Therapeutics does not have its own
warehouse or distribution capabilities, Critical Therapeutics
lacks the resources and experience to establish any of these
functions and Critical Therapeutics does not intend to establish
these functions in the foreseeable future. If Critical
Therapeutics was unable to replace ICS, AmerisourceBergen,
Cardinal Health, McKesson Corporation or Phoenix in a timely
manner in the event of a natural disaster, failure to meet FDA
and other regulatory requirements, business failure, strike or
any other difficulty affecting any of them, the distribution of
ZYFLO CR and ZYFLO could be delayed or interrupted, which would
damage Critical Therapeutics results of operations and
market position. Failure to coordinate financial systems could
also negatively impact Critical Therapeutics ability to
accurately report and forecast product sales and fulfill
Critical Therapeutics regulatory obligations. If Critical
Therapeutics is unable to effectively manage and maintain its
distribution network, sales of ZYFLO CR and ZYFLO could be
severely compromised and Critical Therapeutics business
could be harmed.
Critical
Therapeutics depends on DEY to jointly promote and market ZYFLO
CR. This co-promotion arrangement may not be
successful.
Critical Therapeutics is relying on DEY to jointly promote and
market ZYFLO CR. ZYFLO CR and ZYFLO are Critical
Therapeutics only commercially marketed products. Critical
Therapeutics ability to generate meaningful near-term
revenues from product sales is substantially dependent on the
success of Critical
38
Therapeutics co-promotion arrangement with DEY. DEY
initiated promotional detailing activities for ZYFLO CR in
September 2007 after initiating promotional detailing for ZYFLO
in April 2007.
After September 27, 2010, DEY may terminate the
co-promotion agreement with six-months prior written
notice. In addition, DEY has the right to terminate the
co-promotion agreement with two-months, prior written notice if
ZYFLO CR cumulative net sales for any four consecutive calendar
quarters after commercial launch of ZYFLO CR are less than
$25 million. Each party has the right to terminate the
co-promotion agreement upon the occurrence of a material uncured
breach by the other party. Both Critical Therapeutics and DEY
have agreed to use diligent efforts to promote the applicable
products in the United States during the term of the
co-promotion agreement. In particular, both Critical
Therapeutics and DEY have agreed to provide a minimum number of
details per month for ZYFLO CR.
If DEY were to terminate or breach the co-promotion agreement,
and Critical Therapeutics was unable to enter into a similar
co-promotion agreement with another qualified party in a timely
manner or devote sufficient financial resources or capabilities
to independently promoting and marketing ZYFLO CR, Critical
Therapeutics sales of ZYFLO CR would be limited and
Critical Therapeutics would not be able to generate significant
revenues from product sales. In addition, DEY may choose not to
devote time, effort or resources to the promotion and marketing
of ZYFLO CR beyond the minimum required by the terms of the
co-promotion
agreement. DEY is a subsidiary of Mylan. Mylan acquired DEY in
October 2007 as part of its acquisition of Merck KGaAs
generic business, of which DEY was a part. Critical Therapeutics
cannot predict what impact Mylans acquisition of DEY may
have on Critical Therapeutics co-promotion arrangement
with DEY. For example, in February 2008, Mylan announced that it
is pursuing strategic alternatives for DEY, including the
potential sale of the business. Any decision by DEY or Mylan not
to devote sufficient resources to the co-promotion arrangement
or any future reduction in efforts under the co-promotion
arrangement, including as a result of the sale or potential sale
of DEY by Mylan, would limit Critical Therapeutics ability
to generate significant revenues from product sales.
Furthermore, if DEY does not have sufficient sales capabilities,
as a result of difficulty retaining or hiring sales
representatives following Mylans announcement that it is
pursuing strategic alternatives for DEY or otherwise, then DEY
may not be able to meet its minimum detailing obligations under
the co-promotion agreement.
Critical
Therapeutics depends on MedImmune and Beckman Coulter and
expects to depend on additional collaborators in the future for
a portion of Critical Therapeutics revenues and to
develop, conduct clinical trials with, obtain regulatory
approvals for, and manufacture, market and sell some of Critical
Therapeutics product candidates. These collaborations may
not be successful.
Critical Therapeutics is relying on MedImmune, Inc., a wholly
owned subsidiary of AstraZeneca PLC, or MedImmune, to fund the
development of and to commercialize product candidates in
Critical Therapeutics HMGB1 program. Critical Therapeutics
is relying on Beckman Coulter, Inc., or Beckman Coulter, to fund
the development and to commercialize diagnostics in Critical
Therapeutics HMGB1 program. All of Critical
Therapeutics revenues prior to October 2005, when Critical
Therapeutics commercially launched ZYFLO, were derived from
Critical Therapeutics collaboration agreements with
MedImmune and Beckman Coulter. Additional payments due to
Critical Therapeutics under the collaboration agreements with
MedImmune and Beckman Coulter are generally based on the
achievement of specific development and commercialization
milestones that may not be met. In addition, the collaboration
agreements entitle Critical Therapeutics to royalty payments
that are based on the sales of products developed and marketed
through the collaborations. These future royalty payments may
not materialize or may be less than expected if the related
products are not successfully developed or marketed or if
Critical Therapeutics is forced to license intellectual property
to continue to generate revenues for Critical Therapeutics.
Critical Therapeutics collaboration agreement with
MedImmune generally is terminable by MedImmune at any time upon
six-months notice or upon Critical Therapeutics
material uncured breach of the agreement. In
39
addition, Critical Therapeutics and MedImmune agreed to work
exclusively in the development and commercialization of
HMGB1-inhibiting products for a period of four years, and, after
such time, Critical Therapeutics has agreed to work exclusively
with MedImmune in the development of HMGB1-inhibiting products
for the remaining term of the agreement. If MedImmune were to
terminate or breach this arrangement, and Critical Therapeutics
was unable to enter into a similar collaboration agreement with
another qualified third party in a timely manner or devote
sufficient financial resources or capabilities to continue
development and commercialization on its own, the development
and commercialization of Critical Therapeutics HMGB1
program likely would be delayed, curtailed or terminated. The
delay, curtailment or termination of Critical Therapeutics
HMGB1 program could significantly harm Critical
Therapeutics future prospects.
Critical Therapeutics license agreement with Beckman
Coulter generally is terminable by Beckman Coulter on
90-days
written notice. Each party has the right to terminate the
license agreement upon the occurrence of a material uncured
breach by the other party. If Beckman Coulter were to terminate
or breach Critical Therapeutics arrangement, and Critical
Therapeutics was unable to enter into a similar agreement with
another qualified third party in a timely manner or devote
sufficient financial resources or capabilities to continue
development and commercialization on its own, the development
and commercialization of a diagnostic based on the detection of
HMGB1 likely would be delayed, curtailed or terminated.
In addition, Critical Therapeutics collaborations with
MedImmune and Beckman Coulter and any future collaborative
arrangements that Critical Therapeutics enters into with third
parties may not be scientifically or commercially successful.
Factors that may affect the success of Critical
Therapeutics collaborations include the following:
|
|
|
|
|
Critical Therapeutics collaborators may be pursuing
alternative technologies or developing alternative products,
either on their own or in collaboration with others, that may be
competitive with the product on which they are collaborating
with Critical Therapeutics or that could affect Critical
Therapeutics collaborators commitment to Critical
Therapeutics;
|
|
|
|
reductions in marketing or sales efforts or a discontinuation of
marketing or sales of Critical Therapeutics products by
Critical Therapeutics collaborators would reduce Critical
Therapeutics revenues, which Critical Therapeutics expects
will be based on a percentage of net sales by collaborators;
|
|
|
|
Critical Therapeutics collaborators may terminate their
collaborations with Critical Therapeutics, which could make it
difficult for Critical Therapeutics to attract new collaborators
or adversely affect how Critical Therapeutics is perceived in
the business and financial communities;
|
|
|
|
Critical Therapeutics collaborators may not devote sufficient
time and resources to any collaboration with Critical
Therapeutics, which could prevent Critical Therapeutics from
realizing the potential commercial benefits of that
collaboration; and
|
|
|
|
Critical Therapeutics collaborators may pursue higher
priority programs or change the focus of their development
programs, which could affect their commitments to Critical
Therapeutics.
|
In June 2007, AstraZeneca PLC completed its acquisition of
MedImmune and MedImmune became a wholly owned subsidiary of
AstraZeneca. Critical Therapeutics cannot predict what impact
this transaction may have on Critical Therapeutics HMGB1
collaboration with MedImmune. If MedImmune does not devote
sufficient time and resources to Critical Therapeutics
collaboration or changes the focus of its programs, it could
delay or prevent the achievement of clinical, regulatory and
commercial milestones and prevent Critical Therapeutics from
realizing the potential commercial benefits of the collaboration.
Critical Therapeutics may seek to enter into collaboration
agreements with other parties in the future that relate to
Critical Therapeutics other product candidates, and
Critical Therapeutics is likely to have similar risks with
regard to any such future collaborations.
40
SetPoint
may not be successful in developing a product under the patent
rights and know-how that Critical Therapeutics licensed to
SetPoint relating to the mechanical and electrical stimulation
of the vagus nerve.
Critical Therapeutics has licensed to SetPoint Medical
Corporation (formerly known as Innovative Metabolics, Inc.), or
SetPoint, patent rights and know-how relating to the mechanical
and electrical stimulation of the vagus nerve. SetPoint is an
early-stage company. Critical Therapeutics is not involved in
SetPoints efforts to develop and commercialize a medical
device based on the intellectual property that Critical
Therapeutics licensed to SetPoint. Critical Therapeutics will
receive additional payments under the SetPoint license only if
SetPoint is successful in achieving full regulatory approval of
such a device or receives a royalty, fee or other payment from a
third party in connection with a sublicense of its rights under
Critical Therapeutics license agreement.
If
Critical Therapeutics is unable to enter into additional
collaboration agreements, Critical Therapeutics may not be able
to continue development of its product candidates.
Critical Therapeutics drug development programs and
potential commercialization of Critical Therapeutics
product candidates will require substantial additional cash to
fund expenses to be incurred in connection with these
activities. Critical Therapeutics may seek to enter into
additional collaboration agreements with pharmaceutical or
biotechnology companies to fund all or part of the costs of drug
development and commercialization of product candidates. For
example, Critical Therapeutics has determined as a strategic
matter to seek to enter into collaboration arrangements with
respect to the development of its alpha-7 product candidates and
its zileuton injection product candidate. Critical Therapeutics
is not currently actively engaged in negotiations with respect
to and has no current understandings, agreements or commitments
for any such collaboration arrangements. Critical Therapeutics
faces, and will continue to face, significant competition in
seeking appropriate collaborators. Moreover, collaboration
agreements are complex and time consuming to negotiate, document
and implement. Critical Therapeutics may not be able to enter
into future collaboration agreements, and the terms of the
collaboration agreements, if any, may not be favorable to
Critical Therapeutics. If Critical Therapeutics is not
successful in its efforts to enter into a collaboration
arrangement with respect to a product candidate, Critical
Therapeutics may not have sufficient funds to develop any of its
product candidates internally. If Critical Therapeutics does not
have sufficient funds to develop its product candidates,
Critical Therapeutics will not be able to bring these product
candidates to market and generate revenue. In addition, Critical
Therapeutics inability to enter into collaboration
agreements could delay or preclude the development, manufacture
and/or
commercialization of a product candidate and could have a
material adverse effect on Critical Therapeutics financial
condition and results of operations because:
|
|
|
|
|
Critical Therapeutics may be required to expend its own funds to
advance the product candidate to commercialization;
|
|
|
|
revenue from product sales could be delayed; or
|
|
|
|
Critical Therapeutics may elect not to develop or commercialize
the product candidate.
|
Critical
Therapeutics plans to rely significantly on third parties to
market some product candidates, and these third parties may not
successfully commercialize these product
candidates.
For product candidates with large target physician markets,
Critical Therapeutics plans to rely significantly on sales,
marketing and distribution arrangements with third parties. For
example, Critical Therapeutics relies on MedImmune for the
commercialization of any anti-HMGB1 products that are developed
under the exclusive license and collaboration agreement between
the parties, and Critical Therapeutics plans to rely on Beckman
Coulter for the commercialization of any diagnostic assay for
HMGB1. Critical Therapeutics may not be successful in entering
into additional marketing arrangements in the future and, even
if successful, Critical Therapeutics may not be able to enter
into these arrangements on terms that are favorable to Critical
Therapeutics. In addition, Critical Therapeutics may have
limited or no control over the sales, marketing and distribution
activities of these third parties. If these third parties are
not successful in commercializing the products covered by these
arrangements, Critical Therapeutics future revenues may
suffer.
41
Risks
Relating to Critical Therapeutics Financial Results and
Need for Additional Financing
Critical
Therapeutics has incurred losses since inception and Critical
Therapeutics anticipates that it will continue to incur losses
for the foreseeable future. If Critical Therapeutics does not
generate significant revenues, Critical Therapeutics will not be
able to achieve profitability.
Critical Therapeutics has experienced significant operating
losses in each year since its inception in 2000. Critical
Therapeutics had net losses of $37.0 million in the year
ended December 31, 2007 and $48.8 million in the year
ended December 31, 2006. Critical Therapeutics had net
losses of $17.4 million in the six months ended
June 30, 2008 and $17.6 million in the six months
ended June 30, 2007. As of June 30, 2008, Critical
Therapeutics had an accumulated deficit of approximately
$209 million. Critical Therapeutics recorded revenue from
the sale of ZYFLO and ZYFLO CR of $11.0 million for the
year ended December 31, 2007 and $7.2 million for the
six months ended June 30, 2008. Critical Therapeutics has
not recorded revenue from any products other than ZYFLO CR and
ZYFLO. Critical Therapeutics expects that it will continue to
incur substantial losses for the foreseeable future as it spends
significant amounts to fund its development and
commercialization efforts. Critical Therapeutics expects that
the losses that it incurs will fluctuate from quarter to quarter
and that these fluctuations may be substantial. Critical
Therapeutics will need to generate significant revenues to
achieve profitability. Until Critical Therapeutics is able to
generate such revenues, it will not be profitable and will need
to raise substantial additional capital to fund its operations.
Critical
Therapeutics will require substantial additional capital to fund
its operations. If additional capital is not available, Critical
Therapeutics may need to delay, limit or eliminate its
development and commercialization efforts.
Critical Therapeutics expects to devote substantial resources to
support ongoing sales and marketing efforts for ZYFLO CR and to
fund the development of its other product candidates. Critical
Therapeutics funding requirements will depend on numerous
factors, including:
|
|
|
|
|
the ongoing costs of sales and marketing of ZYFLO CR;
|
|
|
|
the amount and timing of sales and returns of ZYFLO CR and ZYFLO;
|
|
|
|
the costs of ongoing manufacturing activities for ZYFLO CR and
ZYFLO;
|
|
|
|
the time and costs involved in preparing, submitting, obtaining
and maintaining regulatory approvals for Critical
Therapeutics product candidates;
|
|
|
|
the timing, receipt and amount of milestone and other payments,
if any, from DEY, MedImmune, Beckman Coulter, SetPoint or future
collaborators or licensees;
|
|
|
|
the timing, receipt and amount of sales and royalties, if any,
from Critical Therapeutics product candidates;
|
|
|
|
continued progress in Critical Therapeutics research and
development programs, as well as the magnitude of these
programs, including milestone payments to third parties under
Critical Therapeutics license agreements;
|
|
|
|
the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims;
|
|
|
|
the cost of obtaining and maintaining licenses to use patented
technologies;
|
|
|
|
potential acquisition or in-licensing of other products or
technologies;
|
|
|
|
Critical Therapeutics ability to establish and maintain
additional collaborative or co-promotion arrangements; and
|
|
|
|
the ongoing time and costs involved in corporate governance
requirements, including work related to compliance with the
Sarbanes-Oxley Act.
|
Other than payments that Critical Therapeutics may receive from
its collaborations with MedImmune and Beckman Coulter,
sales of ZYFLO CR and ZYFLO represent Critical
Therapeutics only sources of cash flow and revenue.
Critical Therapeutics believes that its ability to access
external funds will depend upon market acceptance
42
of ZYFLO CR, the success of Critical Therapeutics other
preclinical and clinical development programs, the receptivity
of the capital markets to financings by biopharmaceutical
companies, Critical Therapeutics ability to enter into
additional strategic collaborations with corporate and academic
collaborators and the success of such collaborations.
The extent of Critical Therapeutics future capital
requirements is difficult to assess and will depend largely on
Critical Therapeutics ability to successfully
commercialize ZYFLO CR. Based on Critical Therapeutics
current operating plans, Critical Therapeutics believes that its
available cash and cash equivalents and anticipated cash
received from product sales will be sufficient to fund
anticipated levels of operations into the first quarter of 2009.
Critical Therapeutics net cash used for operating
activities was $14.4 million for the year ended
December 31, 2007 and $23.2 million for the six months
ended June 30, 2008. Critical Therapeutics had minimal
capital expenditures for the six months ended June 30,
2008. If Critical Therapeutics existing resources are
insufficient to satisfy its liquidity requirements or if
Critical Therapeutics acquires or licenses rights to additional
products or product candidates, Critical Therapeutics may need
to raise additional external funds through collaborative
arrangements and public or private financings. Under Critical
Therapeutics merger agreement with Cornerstone, any
financing transaction would require Cornerstones consent.
Additional financing may not be available to Critical
Therapeutics on acceptable terms or at all. If Critical
Therapeutics is unable to obtain funding on a timely basis,
Critical Therapeutics may be required to significantly delay,
limit or eliminate one or more of its research, development or
commercialization programs, which could harm its financial
condition and operating results.
Even
if Critical Therapeutics is able to obtain additional capital to
fund its operations, the terms may not be favorable to Critical
Therapeutics or its stockholders.
If Critical Therapeutics future capital requirements
require it to raise additional external funds, collaborative
arrangements or public or private financings may only be
available on unfavorable terms. For example, arrangements with
collaborators or others may require Critical Therapeutics to
relinquish valuable rights to its technologies, product
candidates or products, which Critical Therapeutics would
otherwise pursue on its own.
In addition, debt financing, if available, may involve
agreements that include covenants limiting or restricting
Critical Therapeutics ability to take specific actions,
such as incurring additional debt, making capital expenditures
or declaring dividends. If Critical Therapeutics raises
additional funds by issuing equity securities, stockholders will
experience dilution. Furthermore, any debt financing or
additional equity that Critical Therapeutics raises may contain
terms, such as liquidation and other preferences, that are not
favorable to Critical Therapeutics or its stockholders.
The
audit report issued by Critical Therapeutics independent
registered public accounting firm stating that there is
substantial doubt about Critical Therapeutics ability to
continue as a going concern could make it more difficult for
Critical Therapeutics to obtain additional
financing.
As a result of Critical Therapeutics recurring losses from
operations, accumulated deficit and Critical Therapeutics
expectation that it will incur substantial additional operating
costs for the foreseeable future, as discussed in Note 1 to
Critical Therapeutics consolidated financial statements
beginning on page F-7 of this proxy statement/prospectus,
there is substantial doubt about Critical Therapeutics
ability to continue as a going concern. Critical
Therapeutics ability to continue as a going concern will
require Critical Therapeutics to obtain additional financing to
fund its operations. Critical Therapeutics has prepared its
financial statements on the assumption that it will continue as
a going concern, which contemplates the realization of assets
and discharge of liabilities in the normal course of business.
Doubt about its ability to continue as a going concern may make
it more difficult for Critical Therapeutics to obtain financing
for the continuation of its operations and could result in the
loss of confidence by investors, suppliers and employees.
43
If the
estimates Critical Therapeutics makes, or the assumptions on
which Critical Therapeutics relies, in preparing its financial
statements prove inaccurate, Critical Therapeutics actual
results may vary from those reflected in its
projections.
Critical Therapeutics financial statements have been
prepared in accordance with GAAP. The preparation of these
financial statements requires Critical Therapeutics to make
estimates and judgments that affect the reported amounts of
Critical Therapeutics assets, liabilities, revenues and
expenses, the amounts of charges accrued by Critical
Therapeutics and related disclosure of contingent assets and
liabilities. Critical Therapeutics bases its estimates on
historical experience and on various other assumptions that it
believes to be reasonable under the circumstances. For example,
Critical Therapeutics reserve for potential returns for
ZYFLO CR and ZYFLO is based on its historical experience of
product returns for ZYFLO and other factors that could
significantly impact expected returns. Critical Therapeutics
cannot assure you, however, that its estimates, or the
assumptions underlying them, will be correct. If Critical
Therapeutics estimates are inaccurate, this could
adversely affect its stock price.
Risks
Relating to Intellectual Property and Licenses
If
Critical Therapeutics or its licensors are not able to obtain
and enforce patent and other intellectual property protection
for Critical Therapeutics discoveries or discoveries
Critical Therapeutics has
in-licensed,
Critical Therapeutics ability to prevent third parties
from using Critical Therapeutics inventions and
proprietary information will be limited and Critical
Therapeutics may not be able to operate its business
profitably.
Critical Therapeutics success depends, in part, on its
ability to protect proprietary products, methods and
technologies that Critical Therapeutics invents, develops or
licenses under the patent and other intellectual property laws
of the United States and other countries, so that Critical
Therapeutics can prevent others from using its inventions and
proprietary information. The composition of matter patent for
zileuton in the United States will expire in December 2010.
The patent for ZYFLO CR, which relates only to the
controlled-release technology used to control the release of
zileuton, will expire in June 2012. Critical Therapeutics is
exploring strategies to extend and expand the patent protection
for its zileuton products, but Critical Therapeutics may not be
able to obtain additional patent protection.
Because certain U.S. patent applications are confidential
until patents issue, such as applications filed prior to
November 29, 2000, or applications filed after such date
that will not be filed in foreign countries and for which a
request for non-publication is filed, and because even patent
applications for which no request for non-publication is made
are not published until approximately 18 months after
filing, third parties may have already filed patent applications
for technology covered by Critical Therapeutics pending
patent applications, and Critical Therapeutics patent
applications may not have priority over any such patent
applications of others. There may also be prior art that may
prevent allowance of Critical Therapeutics patent
applications or enforcement of Critical Therapeutics or
Critical Therapeutics licensors issued patents.
Critical Therapeutics patent strategy depends on Critical
Therapeutics ability to rapidly identify and seek patent
protection for Critical Therapeutics discoveries. This
process is expensive and time consuming, and Critical
Therapeutics may not be able to file and prosecute all necessary
or desirable patent applications at a reasonable cost or in a
timely or successful manner. Moreover, the mere issuance of a
patent does not guarantee that it is valid or enforceable. As a
result, even if Critical Therapeutics obtains patents, they may
not be valid or enforceable against third parties.
Critical Therapeutics pending patent applications and
those of its licensors may not result in issued patents. In
addition, the patent positions of pharmaceutical or
biotechnology companies, including Critical Therapeutics, are
generally uncertain and involve complex legal and factual
considerations. The standards that the U.S. Patent and
Trademark Office and its foreign counterparts use to grant
patents are not always applied predictably or uniformly and can
change. There is also no uniform, worldwide policy regarding the
subject matter and scope of claims granted or allowable in
pharmaceutical or biotechnology patents. Accordingly, Critical
Therapeutics does not know the degree of future protection for
its proprietary rights or the breadth of claims that will be
allowed in any patents issued to Critical Therapeutics or to
others with respect to its products in the future.
44
Critical Therapeutics also relies on trade secrets, know-how and
technology, which are not protected by patents, to maintain its
competitive position. If any trade secret, know-how or other
technology not protected by a patent were to be disclosed to, or
independently developed by, a competitor, any competitive
advantage that Critical Therapeutics may have had in the
development or commercialization of its product candidates would
be minimized or eliminated.
Critical Therapeutics confidentiality agreements with its
current and potential collaborators, employees, consultants,
strategic partners, outside scientific collaborators and
sponsored researchers and other advisors may not effectively
prevent disclosure of Critical Therapeutics confidential
information and may not provide an adequate remedy in the event
of unauthorized disclosure of confidential information. Costly
and time-consuming litigation could be necessary to enforce and
determine the scope of Critical Therapeutics proprietary
rights, and failure to obtain or maintain trade secret
protection could adversely affect Critical Therapeutics
competitive business position.
Litigation
regarding patents, patent applications and other proprietary
rights is expensive and time consuming. If Critical Therapeutics
is unsuccessful in litigation or other adversarial proceedings
concerning patents or patent applications, Critical Therapeutics
may not be able to protect its products from competition or
Critical Therapeutics may be precluded from selling its
products. If Critical Therapeutics is involved in such
litigation, it could cause delays in, or prevent Critical
Therapeutics from, bringing products to market and harm Critical
Therapeutics ability to operate.
Critical Therapeutics success will depend in part on its
ability to uphold and enforce the patents or patent applications
owned or co-owned by Critical Therapeutics or licensed to
Critical Therapeutics that cover its products and product
candidates. Litigation, interferences or other adversarial
proceedings relating to Critical Therapeutics patents or
patent applications could take place in the United States or
foreign courts or in the United States or foreign patent offices
or other administrative agencies. Proceedings involving Critical
Therapeutics patents or patent applications could result
in adverse decisions regarding:
|
|
|
|
|
the patentability of Critical Therapeutics applications,
including those relating to Critical Therapeutics
products; or
|
|
|
|
the enforceability, validity or scope of protection offered by
Critical Therapeutics patents, including those relating to
Critical Therapeutics products.
|
These proceedings are costly and time consuming. Critical
Therapeutics may not have sufficient resources to bring these
actions or to bring such actions to a successful conclusion.
Even if Critical Therapeutics is successful in these
proceedings, Critical Therapeutics may incur substantial cost
and divert the time and attention of Critical Therapeutics
management and scientific personnel in pursuit of these
proceedings, which could have a material adverse effect on
Critical Therapeutics business.
If it is determined that Critical Therapeutics does infringe a
patent right of another, Critical Therapeutics may be required
to seek a license, defend an infringement action or challenge
the validity of the patent in court. In addition, if Critical
Therapeutics is not successful in infringement litigation
brought against Critical Therapeutics and Critical Therapeutics
does not license or develop non-infringing technology, Critical
Therapeutics may:
|
|
|
|
|
incur substantial monetary damages, potentially including treble
damages, if Critical Therapeutics is found to have willfully
infringed on such parties patent rights;
|
|
|
|
encounter significant delays in bringing Critical
Therapeutics product candidates to market; or
|
|
|
|
be precluded from participating in the manufacture, use or sale
of Critical Therapeutics products or methods of treatment.
|
If any parties should successfully claim that Critical
Therapeutics creation or use of proprietary technologies
infringes upon their intellectual property rights, Critical
Therapeutics might be forced to pay damages. In addition to any
damages Critical Therapeutics might have to pay, a court could
require Critical Therapeutics to stop the infringing activity.
Moreover, any legal action against Critical Therapeutics or
Critical Therapeutics collaborators claiming damages and
seeking to enjoin commercial activities relating to the affected
products and
45
processes could, in addition to subjecting Critical Therapeutics
to potential liability for damages, require Critical
Therapeutics or Critical Therapeutics collaborators to
obtain a license in order to continue to manufacture or market
the affected products and processes. Any such required license
may not be made available on commercially acceptable terms, if
at all. In addition, some licenses may be non-exclusive and,
therefore, Critical Therapeutics competitors may have
access to the same technology licensed to Critical Therapeutics.
If Critical Therapeutics fails to obtain a required license or
is unable to design around a patent, Critical Therapeutics may
be unable to effectively market some of its technology or
products, which could limit Critical Therapeutics ability
to generate revenues or achieve profitability and possibly
prevent Critical Therapeutics from generating revenue sufficient
to sustain its operations. In addition, Critical
Therapeutics MedImmune collaboration agreement provides
that a portion of the royalties payable to Critical Therapeutics
by MedImmune for licenses to Critical Therapeutics
intellectual property may be offset by amounts paid by MedImmune
to third parties who have competing or superior intellectual
property positions in the relevant fields, which could result in
significant reductions in Critical Therapeutics revenues.
Some of Critical Therapeutics competitors may be able to
sustain the costs of complex intellectual property litigation
more effectively than Critical Therapeutics can because they
have substantially greater resources. Uncertainties resulting
from the initiation and continuation of any litigation could
limit Critical Therapeutics ability to continue its
operations.
Critical
Therapeutics in-licenses a significant portion of its principal
proprietary technologies, and if Critical Therapeutics fails to
comply with its obligations under any of the related agreements,
Critical Therapeutics could lose license rights that are
necessary to develop and market its zileuton products, its HMGB1
products and some of its other product candidates.
Critical Therapeutics is a party to a number of licenses that
give Critical Therapeutics rights to third-party intellectual
property that is necessary for Critical Therapeutics
business. In fact, Critical Therapeutics acquired the rights to
each of its product candidates under licenses with third
parties. These licenses impose various development,
commercialization, funding, royalty, diligence and other
obligations on Critical Therapeutics. If Critical Therapeutics
breaches these obligations, Critical Therapeutics
licensors may have the right to terminate the licenses or render
the licenses non-exclusive, which would result in Critical
Therapeutics being unable to develop, manufacture and sell
products that are covered by the licensed technology, or at
least to do so on an exclusive basis.
Risk
Relating to Regulatory and Legal Compliance by Critical
Therapeutics
Critical
Therapeutics will spend considerable time and money complying
with federal and state laws and regulations, and, if Critical
Therapeutics is unable to fully comply with such laws and
regulations, Critical Therapeutics could face substantial
penalties.
Critical Therapeutics is subject to extensive regulation by
federal and state governments. The laws that directly or
indirectly affect Critical Therapeutics business include,
but are not limited to, the following:
|
|
|
|
|
federal Medicare and Medicaid anti-kickback laws, which prohibit
persons from knowingly and willfully soliciting, offering,
receiving or providing remuneration, directly or indirectly, in
cash or in kind, to induce either the referral of an individual,
or furnishing or arranging for a good or service, for which
payment may be made under federal healthcare programs such as
the Medicare and Medicaid programs;
|
|
|
|
other Medicare laws and regulations that establish the
requirements for coverage and payment for Critical
Therapeutics products, including the amount of such
payments;
|
|
|
|
the federal False Claims Act, which imposes civil and criminal
liability on individuals and entities who submit, or cause to be
submitted, false or fraudulent claims for payment to the
government;
|
|
|
|
the federal Health Insurance Portability and Accountability Act
of 1996, or HIPAA, which prohibits executing a scheme to defraud
any health care benefit program, including private payors and,
further, requires Critical Therapeutics to comply with standards
regarding privacy and security of individually identifiable
health information and conduct certain electronic transactions
using standardized code sets;
|
46
|
|
|
|
|
the federal False Statements statute, which prohibits knowingly
and willfully falsifying, concealing or covering up a material
fact or making any materially false statement in connection with
the delivery of or payment for health care benefits, items or
services;
|
|
|
|
the federal Food, Drug, and Cosmetic Act, or FDCA, which
regulates development, manufacturing, labeling, marketing,
distribution and sale of prescription drugs and medical devices;
|
|
|
|
the federal Prescription Drug Marketing Act of 1987, which
regulates the distribution of drug samples to physicians and
other prescribers who are authorized under state law to receive
and dispense drug samples;
|
|
|
|
state and foreign law equivalents of the foregoing;
|
|
|
|
state food and drug laws, pharmacy acts and state pharmacy board
regulations, which govern the sale, distribution, use,
administration and prescribing of prescription drugs; and
|
|
|
|
state laws that prohibit the practice of medicine by
non-physicians and fee-splitting arrangements between physicians
and non-physicians, as well as state law equivalents to the
federal Medicare and Medicaid anti-kickback laws, which may not
be limited to government reimbursed items or services.
|
On January 1, 2006, Critical Therapeutics became a
participant in the Medicaid rebate program established by the
Omnibus Budget Reconciliation Act of 1990, as amended, effective
in 1993. Under the Medicaid rebate program, Critical
Therapeutics pays a rebate for each unit of Critical
Therapeutics product reimbursed by Medicaid. The amount of
the rebate for each product is set by law. Critical Therapeutics
is also required to pay certain statutorily defined rebates on
Medicaid purchases for reimbursement on prescription drugs under
state Medicaid plans. Both the federal government and state
governments have initiated investigations into the rebate
practices of many pharmaceutical companies to ensure compliance
with these rebate programs. Any investigation of Critical
Therapeutics rebate practices could be costly, could
divert the attention of Critical Therapeutics management
and could damage Critical Therapeutics reputation.
If Critical Therapeutics past or present operations are
found to be in violation of any of the laws described above or
other laws or governmental regulations to which Critical
Therapeutics or its customers are subject, Critical Therapeutics
may be subject to the applicable penalty associated with the
violation, including civil and criminal penalties, damages,
fines, exclusion from Medicare and Medicaid programs and
curtailment or restructuring of Critical Therapeutics
operations. Similarly, if Critical Therapeutics customers
are found non compliant with applicable laws, they may be
subject to sanctions, which could also have a negative impact on
Critical Therapeutics. In addition, if Critical Therapeutics is
required to obtain permits or licenses under these laws that
Critical Therapeutics does not already possess, Critical
Therapeutics may become subject to substantial additional
regulation or incur significant expense. Any penalties, damages,
fines, curtailment or restructuring of Critical
Therapeutics operations would adversely affect its ability
to operate its business and its financial results. Health care
fraud and abuse regulations are complex, and even minor
irregularities can potentially give rise to claims of a
violation. The risk of Critical Therapeutics being found
in violation of these laws is increased by the fact that many of
them have not been fully interpreted by the regulatory
authorities or the courts, and their provisions are open to a
variety of interpretations, and additional legal or regulatory
change.
If Critical Therapeutics promotional activities fail to
comply with the FDAs regulations or guidelines, Critical
Therapeutics may be subject to enforcement action by the FDA.
For example, Critical Therapeutics received a warning letter
from the FDA in November 2005 relating to certain promotional
material that included an illustration of the mechanism of
action for ZYFLO. The FDA asserted that the promotional material
incorporating the illustration was false or misleading because
it presented efficacy claims for ZYFLO, but failed to contain
fair balance by not communicating the risks associated with its
use and failing to present the approved indication for ZYFLO. In
response to the warning letter, and as requested by the FDA,
Critical Therapeutics stopped disseminating the promotional
material containing the mechanism of action and Critical
Therapeutics provided a written response to the FDA. As part of
Critical Therapeutics response, Critical Therapeutics
provided a description of its plan to disseminate corrective
messages about the promotional material to those who received
this material. Critical Therapeutics revised the promotional
material containing the mechanism of action to address the
FDAs concerns regarding fair balance. If Critical
Therapeutics
47
promotional activities fail to comply with the FDAs
regulations or guidelines, Critical Therapeutics could be
subject to additional regulatory actions by the FDA, including
product seizure, injunctions, and other penalties and Critical
Therapeutics reputation and the reputation of ZYFLO CR in
the market could be harmed.
Any action against Critical Therapeutics for violation of these
laws, even if Critical Therapeutics successfully defends against
it, could cause Critical Therapeutics to incur significant legal
expenses, divert Critical Therapeutics managements
attention from operating Critical Therapeutics business
and damage Critical Therapeutics reputation or Critical
Therapeutics brands. If there is a change in law,
regulation or administrative or judicial interpretations,
Critical Therapeutics may have to change or discontinue its
business practices or its existing business practices could be
challenged as unlawful, which could materially harm its
business, financial condition and results of operations.
State
pharmaceutical marketing and promotional compliance and
reporting requirements may expose Critical Therapeutics to
regulatory and legal action by state governments or other
governmental authorities.
In recent years, several states, including California, Maine,
Minnesota, Nevada, New Mexico, Vermont and West Virginia, as
well as the District of Columbia, have enacted legislation
requiring pharmaceutical companies to establish marketing and
promotional compliance programs and file periodic reports with
the state on sales, marketing, pricing, reporting pricing and
other activities. For example, a California statute effective
July 1, 2005 requires pharmaceutical companies to adopt and
post on their public web site a comprehensive compliance program
that complies with the Pharmaceutical Research and Manufacturers
of America Code on Interactions with Healthcare
Professionals and the Office of Inspector General of the
Department of Health and Human Services Compliance Program
Guidance for Pharmaceutical Manufacturers. In addition, such
compliance program must establish a specific annual dollar limit
on gifts or other items given to individual healthcare
professionals in California.
Maine, Minnesota, New Mexico, Nevada, Vermont, West Virginia and
the District of Columbia have also enacted statutes of varying
scope that impose reporting and disclosure requirements upon
pharmaceutical companies pertaining to drug pricing and payments
and costs associated with pharmaceutical marketing, advertising
and promotional activities, as well as restrictions upon the
types of gifts that may be provided to health care
practitioners. Similar legislation is being considered in a
number of other states. Many of these requirements are new and
uncertain, and available guidance is limited. Critical
Therapeutics is in the process of identifying the universe of
state laws applicable to pharmaceutical companies and is taking
steps to ensure that Critical Therapeutics comes into compliance
with all such laws. Unless and until Critical Therapeutics is in
full compliance with these laws, Critical Therapeutics could
face enforcement action and fines and other penalties, and could
receive adverse publicity, all of which could materially harm
Critical Therapeutics business.
Recently
enacted legislation may make it more difficult and costly for
Critical Therapeutics to obtain regulatory approval of its
product candidates and to produce, market and distribute its
existing products.
On September 27, 2007, President Bush signed into law the
Food and Drug Administration Amendments Act of 2007, or the
FDAAA. The FDAAA grants a variety of new powers to the FDA, many
of which are aimed at assuring drug safety and monitoring the
safety of drug products after approval. Under the FDAAA,
companies that violate the new law are subject to substantial
civil monetary penalties. While Critical Therapeutics expects
the FDAAA to have a substantial effect on the pharmaceutical
industry, the extent of that effect is not yet known. As the FDA
issues regulations, guidance and interpretations relating to the
new legislation, the impact on the industry, as well as Critical
Therapeutics business, will become more clear. The new
requirements and other changes that the FDAAA imposes may make
it more difficult, and likely more costly, to obtain approval of
new pharmaceutical products and to produce, market and
distribute existing products.
48
Critical
Therapeutics corporate compliance and corporate governance
programs cannot guarantee that Critical Therapeutics is in
compliance with all potentially applicable
regulations.
The development, manufacturing, pricing, marketing, sales and
reimbursement of ZYFLO CR and ZYFLO and Critical
Therapeutics product candidates, together with Critical
Therapeutics general operations, are subject to extensive
regulation by federal, state and other authorities within the
United States and numerous entities outside of the United
States. Critical Therapeutics is a relatively small company and
had approximately 42 employees as of September 15,
2008. Critical Therapeutics relies heavily on third parties to
conduct many important functions. While Critical Therapeutics
has developed and instituted a corporate compliance program
based on what Critical Therapeutics believes are the current
best practices and continues to update the program in response
to newly implemented and changing regulatory requirements, it is
possible that Critical Therapeutics may not be in compliance
with all potentially applicable regulations. If Critical
Therapeutics fails to comply with any of these regulations,
Critical Therapeutics could be subject to a range of regulatory
actions, including significant fines, litigation or other
sanctions. Any action against Critical Therapeutics for a
violation of these regulations, even if Critical Therapeutics
successfully defends against it, could cause Critical
Therapeutics to incur significant legal expenses, divert
Critical Therapeutics managements attention and harm
Critical Therapeutics reputation.
As a publicly traded company, Critical Therapeutics is subject
to significant legal and regulatory requirements, including the
Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and
related regulations, some of which have either only recently
become applicable to Critical Therapeutics or are subject to
change. For example, Critical Therapeutics is incurring
additional expenses and devoting significant management time and
attention to evaluating its internal control systems to allow
Critical Therapeutics management to report on, and
Critical Therapeutics independent registered public
accounting firm to attest to, Critical Therapeutics
internal control over financial reporting, as required by
Section 404 of the Sarbanes-Oxley Act. If the controls and
procedures that Critical Therapeutics has implemented do not
comply with all of the relevant rules and regulations of the SEC
and NASDAQ, Critical Therapeutics may be subject to sanctions or
investigation by regulatory authorities, including the SEC or
NASDAQ. This type of action could adversely affect Critical
Therapeutics financial results or investors
confidence in Critical Therapeutics and Critical
Therapeutics ability to access the capital markets and
could result in the delisting of Critical Therapeutics
common stock from NASDAQ. If Critical Therapeutics fails to
develop and maintain adequate controls and procedures, Critical
Therapeutics may be unable to provide the required financial
information in a timely and reliable manner, which could cause a
decline in Critical Therapeutics stock price.
Critical
Therapeutics sales depend on payment and reimbursement
from third-party payors, and a reduction in the payment rate or
reimbursement could result in decreased use or sales of Critical
Therapeutics products.
Critical Therapeutics sales of ZYFLO CR and ZYFLO are, and
any future sales of Critical Therapeutics product
candidates will be, dependent, in part, on the availability of
reimbursement from third-party payors such as state and federal
governments, under programs such as Medicare and Medicaid, and
private insurance plans. There have been, there are and Critical
Therapeutics expects there will continue to be, state and
federal legislative and administrative proposals that could
limit the amount that state or federal governments will pay to
reimburse the cost of pharmaceutical and biologic products. For
example, the Medicare Prescription Drug Improvement and
Modernization Act of 2003, or the MMA, was signed into law in
December 2003. Legislative or administrative acts that reduce
reimbursement for Critical Therapeutics products could
adversely impact Critical Therapeutics business. In
addition, Critical Therapeutics believes that private insurers,
such as MCOs, may adopt their own reimbursement reductions in
response to legislation. Any reduction in reimbursement for
Critical Therapeutics products could materially harm
Critical Therapeutics results of operations. In addition,
Critical Therapeutics believes that the increasing emphasis on
managed care in the United States has and will continue to put
pressure on the price and usage of Critical Therapeutics
products, which may adversely impact Critical Therapeutics
product sales. Furthermore, when a new drug product is approved,
governmental and private reimbursement for that product, and the
amount for which that product will be reimbursed, are uncertain.
Critical Therapeutics cannot predict the availability or amount
of
49
reimbursement for Critical Therapeutics product candidates
and current reimbursement policies for marketed products may
change at any time.
The MMA established a prescription drug benefit that became
effective in 2006 for all Medicare beneficiaries. Critical
Therapeutics cannot be certain that ZYFLO CR, ZYFLO or any of
Critical Therapeutics product candidates still in
development, will be included in the Medicare prescription drug
benefit. Even if Critical Therapeutics products are
included, the MCOs, health maintenance organizations, or HMOs,
preferred provider organizations, or PPOs, and private health
plans that administer the Medicare drug benefit have the ability
to negotiate price and demand discounts from pharmaceutical and
biotechnology companies that may implicitly create price
controls on prescription drugs. On the other hand, the drug
benefit may increase the volume of pharmaceutical drug
purchases, offsetting at least in part these potential price
discounts. In addition, MCOs, HMOs, PPOs, health care
institutions and other government agencies continue to seek
price discounts. Because MCOs, HMOs, PPOs and private health
plans will administer the Medicare drug benefit, managed care
and private health plans will influence prescription decisions
for a larger segment of the population. In addition, certain
states have proposed and certain other states have adopted
various programs to control prices for senior citizens and drug
programs for people with low incomes, including price or patient
reimbursement constraints, restrictions on access to certain
products, and bulk purchasing of drugs.
If Critical Therapeutics succeeds in bringing products in
addition to ZYFLO CR and ZYFLO to the market, these products may
not be considered cost-effective, and reimbursement to the
patient may not be available or sufficient to allow Critical
Therapeutics to sell its product candidates on a competitive
basis to a sufficient patient population. Because Critical
Therapeutics product candidates are in the development
stage, Critical Therapeutics is unable at this time to determine
the cost-effectiveness of these product candidates. Critical
Therapeutics may need to conduct expensive pharmacoeconomic
trials in order to demonstrate their cost-effectiveness. Sales
of prescription drugs are highly dependent on the availability
and level of reimbursement to the consumer from third-party
payors, such as government and private insurance plans. These
third-party payors frequently require that drug companies
provide them with predetermined discounts or rebates from list
prices, and third-party payors are increasingly challenging the
prices charged for medical products. Because Critical
Therapeutics product candidates are in the development
stage, Critical Therapeutics does not know the level of
reimbursement, if any, it will receive for those product
candidates if they are successfully developed. If the
reimbursement Critical Therapeutics receives for any of its
product candidates is inadequate in light of Critical
Therapeutics development and other costs, Critical
Therapeutics ability to realize profits from the affected
product candidate would be limited. If reimbursement for
Critical Therapeutics marketed products changes adversely
or if Critical Therapeutics fails to obtain adequate
reimbursement for its other current or future products, health
care providers may limit how much or under what circumstances
they will prescribe or administer them, which could reduce use
of Critical Therapeutics products or cause Critical
Therapeutics to reduce the price of its products.
Risks
Relating to Development, Clinical Testing and Regulatory
Approval of Critical Therapeutics Product
Candidates.
Critical
Therapeutics may not be successful in its efforts to advance and
expand its portfolio of product candidates.
An element of Critical Therapeutics strategy is to develop
and commercialize product candidates that address large unmet
medical needs. Critical Therapeutics seeks to do so through:
|
|
|
|
|
preclinical studies to evaluate product candidates;
|
|
|
|
sponsored research programs with academic and other research
institutions and individual doctors, chemists and
researchers; and
|
|
|
|
collaborations with other pharmaceutical or biotechnology
companies with complementary clinical development or
commercialization capabilities or capital to assist in funding
product development and commercialization.
|
In addition, subject to having sufficient cash and other
resources to develop or commercialize additional products,
Critical Therapeutics may seek to in-license or acquire product
candidates or approved products. However, Critical Therapeutics
may be unable to license or acquire suitable product candidates
or products
50
from third parties for a number of reasons. In particular, the
licensing and acquisition of pharmaceutical products is
competitive. A number of more established companies are also
pursuing strategies to license or acquire products. These
established companies may have a competitive advantage over
Critical Therapeutics due to their size, cash resources or
greater clinical development and commercialization capabilities.
Other factors that may prevent Critical Therapeutics from
licensing or otherwise acquiring suitable product candidates or
approved products include the following:
|
|
|
|
|
Critical Therapeutics may be unable to license or acquire the
relevant technology on terms that would allow Critical
Therapeutics to make an appropriate return from the product;
|
|
|
|
companies that perceive Critical Therapeutics as a competitor
may be unwilling to assign or license their product rights to
Critical Therapeutics;
|
|
|
|
Critical Therapeutics may be unable to identify suitable
products or product candidates within Critical
Therapeutics areas of expertise; and
|
|
|
|
Critical Therapeutics may have inadequate cash resources or may
be unable to access public or private financing to obtain rights
to suitable products or product candidates from third parties.
|
If Critical Therapeutics is unable to develop suitable potential
product candidates through Critical Therapeutics
preclinical studies or sponsored research programs or by
obtaining rights from third parties, Critical Therapeutics will
not be able to increase its revenues in future periods, which
could result in significant harm to Critical Therapeutics
financial position and adversely impact Critical
Therapeutics stock price.
If
Critical Therapeutics does not obtain the regulatory approvals
or clearances required to market and sell Critical
Therapeutics product candidates under development,
Critical Therapeutics business may be
unsuccessful.
Neither Critical Therapeutics nor any of its collaborators may
market any of Critical Therapeutics products or its
product candidates under development in the United States,
Europe or in any other country without marketing approval from
the FDA or the equivalent foreign regulatory agency. ZYFLO CR
and ZYFLO are currently Critical Therapeutics only
commercial products and can only be marketed in the United
States.
The regulatory process to obtain marketing approval or clearance
for a new drug or biologic takes many years, requires
expenditures of substantial resources, is uncertain and is
subject to unanticipated delays. Adverse side effects of a
product candidate in a clinical trial could result in the FDA or
foreign regulatory authorities refusing to approve or clear a
particular product candidate for any or all indications for use.
The FDA and foreign regulatory agencies have substantial
discretion in the drug approval process and can deny, delay or
limit approval of a product candidate for a variety of reasons.
If Critical Therapeutics does not receive the required
regulatory approval or clearance to market any of its product
candidates under development, Critical Therapeutics
ability to generate product revenue and achieve profitability,
Critical Therapeutics reputation and Critical
Therapeutics ability to raise additional capital will be
materially impaired.
Critical
Therapeutics limited experience in obtaining regulatory
approvals could delay, limit or prevent such approvals for its
product candidates.
Critical Therapeutics has only limited experience in preparing
applications and obtaining regulatory approvals and clearances
for its product candidates. Since inception, Critical
Therapeutics has received approval to market only two drugs in
the United States, ZYFLO CR and ZYFLO. Critical
Therapeutics limited experience in this regard could delay
or limit approval of its product candidates if it is unable to
effectively manage the applicable regulatory process with either
the FDA or foreign regulatory authorities. In addition,
significant errors or ineffective management of the regulatory
process could prevent approval of a product candidate,
especially given the substantial discretion that the FDA and
foreign regulatory authorities have in this process.
If
clinical trials for Critical Therapeutics product
candidates are not successful, Critical Therapeutics may not be
able to develop, obtain regulatory approval for and
commercialize these product candidates
successfully.
Critical Therapeutics product candidates, such as zileuton
injection and product candidates directed toward the bodys
inflammatory response, including in its alpha-7 and HMGB1
preclinical programs, are still in
51
development and remain subject to clinical testing and
regulatory approval or clearance. In order to obtain regulatory
approvals or clearances for the commercial sale of Critical
Therapeutics product candidates, Critical Therapeutics and
its collaborators will be required to complete extensive
clinical trials in humans to demonstrate the safety and efficacy
of Critical Therapeutics product candidates. Critical
Therapeutics may not be able to obtain authority from the FDA,
institutional review boards or other regulatory agencies to
commence or complete these clinical trials. If permitted, such
clinical testing may not prove that Critical Therapeutics
product candidates are safe and effective to the extent
necessary to permit Critical Therapeutics to obtain marketing
approvals or clearances from regulatory authorities. One or more
of Critical Therapeutics product candidates may not
exhibit the expected therapeutic results in humans, may cause
harmful side effects or have other unexpected characteristics
that may delay or preclude submission and regulatory approval or
clearance or limit commercial use if approved or cleared.
Furthermore, Critical Therapeutics, one of its collaborators,
institutional review boards or regulatory agencies may hold,
suspend or terminate clinical trials at any time if it is
believed that the subjects or patients participating in such
trials are being exposed to unacceptable health risks or for
other reasons.
For example, in March 2006, Critical Therapeutics announced that
it had discontinued a Phase II clinical trial of ethyl
pyruvate, which Critical Therapeutics refers to as CTI-01, a
small molecule product candidate that Critical Therapeutics had
been developing for prevention of complications that can occur
in patients after cardiopulmonary bypass, a procedure commonly
performed during heart surgery. After reviewing the final data
from the trial, Critical Therapeutics decided to discontinue
further development of CTI-01. Critical Therapeutics
subsequently terminated, effective in February 2007, the license
agreements between Critical Therapeutics and the University of
Pittsburgh and Xanthus Pharmaceuticals, Inc., formerly Phenome
Sciences, Inc., or Xanthus Pharmaceuticals, related to patent
rights related to CTI-01 controlled by University of Pittsburgh
and Xanthus Pharmaceuticals.
Preclinical testing and clinical trials of new drug and biologic
candidates are lengthy and expensive and the historical failure
rate for such candidates is high. Critical Therapeutics may not
be able to advance any more product candidates into clinical
trials. Even if Critical Therapeutics does successfully enter
into clinical trials, the results from preclinical testing of a
product candidate may not predict the results that will be
obtained in human clinical trials. In addition, positive results
demonstrated in preclinical studies and clinical trials that
Critical Therapeutics completes may not be indicative of results
obtained in additional clinical trials. Clinical trials may take
several years to complete, and failure can occur at any stage of
testing.
Adverse or inconclusive clinical trial results concerning any of
Critical Therapeutics product candidates could require
Critical Therapeutics to conduct additional clinical trials,
result in increased costs and significantly delay the submission
for marketing approval or clearance for such product candidates
with the FDA or other regulatory authorities or result in a
submission or approval for a narrower indication. If clinical
trials fail, Critical Therapeutics product candidates
would not become commercially viable.
If
clinical trials for Critical Therapeutics product
candidates are delayed, Critical Therapeutics would be unable to
commercialize its product candidates on a timely basis, which
would require Critical Therapeutics to incur additional costs
and delay the receipt of any revenues from product
sales.
Critical Therapeutics cannot predict whether it will encounter
problems with any of its completed, ongoing or planned clinical
trials that will cause regulatory authorities, institutional
review boards, one of its collaborators or Critical Therapeutics
to delay or suspend those clinical trials, or delay the analysis
of data from Critical Therapeutics ongoing clinical trials.
Any of the following could delay the completion of Critical
Therapeutics ongoing and planned clinical trials:
|
|
|
|
|
ongoing discussions with the FDA or comparable foreign
authorities regarding the scope or design of Critical
Therapeutics clinical trials;
|
|
|
|
delays or the inability to obtain required approvals from
institutional review boards or other governing entities at
clinical sites selected for participation in Critical
Therapeutics clinical trials;
|
|
|
|
delays in enrolling patients and volunteers into clinical trials;
|
|
|
|
lower than anticipated retention rates of patients and
volunteers in clinical trials;
|
52
|
|
|
|
|
the need to repeat clinical trials as a result of inconclusive
or negative results or poorly executed testing;
|
|
|
|
insufficient supply or deficient quality of product candidate
materials or other materials necessary to conduct Critical
Therapeutics clinical trials;
|
|
|
|
unfavorable FDA inspection and review of a clinical trial site
or records of any clinical or preclinical investigation;
|
|
|
|
serious and unexpected drug-related side effects experienced by
participants in ongoing or past clinical trials for the same or
a different indication;
|
|
|
|
serious and unexpected drug-related side effects observed during
ongoing or past preclinical studies; or
|
|
|
|
the placement of a clinical hold on a trial.
|
Critical Therapeutics ability to enroll patients in its
clinical trials in sufficient numbers and on a timely basis will
be subject to a number of factors, including the size of the
patient population, the nature of the protocol, the proximity of
patients to clinical sites, the seasonality of the disease, the
availability of effective treatments for the relevant disease,
competing trials with other product candidates and the
eligibility criteria for the clinical trial. Delays in patient
enrollment can result in increased costs and longer development
times. In addition, subjects may drop out of Critical
Therapeutics clinical trials and thereby impair the
validity or statistical significance of the trials. Delays in
patient enrollment and the related increase in costs also could
cause Critical Therapeutics to decide to discontinue a clinical
trial prior to completion of the trial.
For example, in March 2008, Critical Therapeutics discontinued
its Phase IV clinical trial for ZYFLO CR designed to
generate data in the current patient treatment setting because
of patient enrollment that was significantly slower than
Critical Therapeutics had anticipated. Critical Therapeutics
initiated the trial in July 2007 and had enrolled only
approximately 25% of the patients prior to discontinuing the
trial. Critical Therapeutics had planned to use data from this
trial to support ZYFLO CRs market position, and Critical
Therapeutics may have increased difficulty promoting ZYFLO CR to
physicians without this data.
Critical Therapeutics expects to rely on academic institutions
and contract research organizations to supervise or monitor some
or all aspects of the clinical trials for the product candidates
Critical Therapeutics advances into clinical testing.
Accordingly, Critical Therapeutics has less control over the
timing and other aspects of these clinical trials than if
Critical Therapeutics conducted them entirely on its own.
As a result of these factors, Critical Therapeutics or third
parties on whom Critical Therapeutics relies may not
successfully begin or complete Critical Therapeutics
clinical trials in the time periods Critical Therapeutics has
forecasted, if at all. If the results of Critical
Therapeutics ongoing or planned clinical trials for
Critical Therapeutics product candidates are not available
when Critical Therapeutics expects or if Critical Therapeutics
encounters any delay in the analysis of data from Critical
Therapeutics preclinical studies and clinical trials,
Critical Therapeutics may be unable to submit its product
candidates for regulatory approval or clearance or conduct
additional clinical trials on the schedule Critical
Therapeutics currently anticipates.
If clinical trials are delayed, the commercial viability of
Critical Therapeutics product candidates may be reduced.
If Critical Therapeutics incurs costs and delays in its
programs, or if Critical Therapeutics does not successfully
develop and commercialize its products, Critical
Therapeutics future operating and financial results will
be materially affected.
Even
if Critical Therapeutics obtains regulatory approvals or
clearances, Critical Therapeutics products and product
candidates will be subject to ongoing regulatory requirements
and review. If Critical Therapeutics fails to comply with
continuing U.S. and applicable foreign regulations, Critical
Therapeutics could lose permission to manufacture, distribute
and sell its products and, if approved, its product
candidates.
Critical Therapeutics products and product candidates are
subject to continuing regulatory review after approval,
including the review of spontaneous adverse drug experiences and
clinical results from any post-market testing required as a
condition of approval that are reported after Critical
Therapeutics product candidates become commercially
available. The manufacturer and the manufacturing facilities
Critical Therapeutics uses to make ZYFLO CR, ZYFLO CR tablet
cores, ZYFLO and zileuton API and any of its
53
product candidates will also be subject to periodic review and
inspection by the FDA. The subsequent discovery of previously
unknown problems with a product, manufacturer or facility may
result in restrictions on the product or manufacturer or
facility, including withdrawal of the product from the market.
Critical Therapeutics product promotion and advertising
will also be subject to regulatory requirements and continuing
FDA review.
As part of the approval of the NDA for ZYFLO CR in May 2007, the
FDA required Critical Therapeutics to conduct a pediatric
clinical trial of ZYFLO CR as a post-approval commitment and
report the results to the FDA by June 2010. If Critical
Therapeutics does not successfully begin and complete this
clinical trial in the time required by the FDA, Critical
Therapeutics ability to market and sell ZYFLO CR may be
hindered, and Critical Therapeutics business may be harmed
as a result.
Numerous proposals have been made in recent months and years to
impose new requirements on drug approvals, expand post-approval
requirements, and restrict sales and promotional activities. For
example, an NDA requires that an applicant submit risk
evaluation and minimization plans to monitor and address
potential safety issues for products upon approval, and federal
legislation has been proposed that would require all new drug
applicants to submit risk evaluation and minimization plans to
monitor and address potential safety issues for products upon
approval, grant the FDA the authority to impose risk management
measures for marketed products and to mandate labeling changes
in certain circumstances, and establish new requirements for
disclosing the results of clinical trials. Additional measures
have also been proposed to address perceived shortcomings in the
FDAs handling of drug safety issues, and to limit
pharmaceutical company sales and promotional practices that some
see as excessive or improper. If these or other legal or
regulatory changes are enacted, it may become more difficult or
burdensome for Critical Therapeutics to obtain extended or new
product approvals, and Critical Therapeutics current
approvals may be restricted or subject to onerous post-approval
requirements. Such changes may increase Critical
Therapeutics costs and adversely affect Critical
Therapeutics operations. The ability of Critical
Therapeutics or its partners to commercialize approved products
successfully may be hindered, and Critical Therapeutics
business may be harmed as a result.
If
Critical Therapeutics or its third-party manufacturers or
service providers fail to comply with applicable laws and
regulations, Critical Therapeutics or they could be subject to
enforcement actions, which could adversely affect Critical
Therapeutics ability to market and sell Critical
Therapeutics product candidates and may harm Critical
Therapeutics reputation.
If Critical Therapeutics or its third-party manufacturers or
service providers fail to comply with applicable federal, state
or foreign laws or regulations, Critical Therapeutics could be
subject to enforcement actions, which could adversely affect
Critical Therapeutics ability to develop, market and sell
Critical Therapeutics product candidates successfully and
may harm Critical Therapeutics reputation and hinder
market acceptance of Critical Therapeutics product
candidates. These enforcement actions include:
|
|
|
|
|
product seizures;
|
|
|
|
voluntary or mandatory recalls;
|
|
|
|
suspension of review or refusal to approve pending applications;
|
|
|
|
voluntary or mandatory patient or physician notification;
|
|
|
|
withdrawal of product approvals;
|
|
|
|
restrictions on, or prohibitions against, marketing Critical
Therapeutics product candidates;
|
|
|
|
restrictions on applying for or obtaining government bids;
|
|
|
|
fines;
|
|
|
|
restrictions on importation of Critical Therapeutics
product candidates;
|
|
|
|
injunctions; and
|
|
|
|
civil and criminal penalties.
|
54
If the
market is not receptive to Critical Therapeutics product
candidates, Critical Therapeutics will be unable to generate
revenues from sales of these products.
The probability of commercial success of each of Critical
Therapeutics product candidates is subject to significant
uncertainty. Factors that Critical Therapeutics believes will
materially affect market acceptance of Critical
Therapeutics product candidates under development include:
|
|
|
|
|
the timing of Critical Therapeutics receipt of any
marketing approvals, the terms of any approval and the countries
in which approvals are obtained;
|
|
|
|
the safety, efficacy and ease of administration;
|
|
|
|
the therapeutic benefit or other improvement over existing
comparable products;
|
|
|
|
pricing and cost effectiveness;
|
|
|
|
the ability to be produced in commercial quantities at
acceptable costs;
|
|
|
|
the availability of reimbursement from third-party payors such
as state and federal governments, under programs such as
Medicare and Medicaid, and private insurance plans and
MCOs; and
|
|
|
|
the extent and success of Critical Therapeutics sales and
marketing efforts.
|
The failure of Critical Therapeutics product candidates to
achieve market acceptance would prevent Critical Therapeutics
from ever generating meaningful revenues from sales of these
product candidates.
Risks
Relating to Critical Therapeutics Common Stock
Critical
Therapeutics stock price is subject to fluctuation, which
may cause an investment in Critical Therapeutics stock to
suffer a decline in value.
The market price of Critical Therapeutics common stock may
fluctuate significantly in response to factors that are beyond
Critical Therapeutics control. The stock market in general
has recently experienced extreme price and volume fluctuations.
The market prices of securities of pharmaceutical and
biotechnology companies have been extremely volatile and have
experienced fluctuations that often have been unrelated or
disproportionate to the operating performance of these
companies. These broad market fluctuations could result in
extreme fluctuations in the price of Critical Therapeutics
common stock, which could cause a decline in the value of
Critical Therapeutics common stock. For example, between
September 1, 2007 and September 29, 2008, the last
practicable date before the printing of this proxy
statement/prospectus, the trading price of Critical
Therapeutics common stock as reported on NASDAQ ranged
from a high of $2.70 per share to a low of $0.12 per
share. On April 30, 2008, the last day prior to the public
announcement of the proposed merger, the closing price per share
of Critical Therapeutics common stock as reported on The
NASDAQ Global Market was $0.62. On September 29, 2008, the
last practicable date before the printing of this proxy
statement/prospectus, the closing price per share of Critical
Therapeutics common stock as reported on The NASDAQ
Capital Market was $0.17, which represents an
approximately 73% decrease from the closing price on
April 30, 2008.
If
Critical Therapeutics fails to continue to meet all applicable
continued listing requirements of The NASDAQ Capital Market and
NASDAQ determines to delist Critical Therapeutics common
stock, the market liquidity and market price of Critical
Therapeutics common stock could decline.
Critical Therapeutics common stock is currently listed on
The NASDAQ Capital Market. In order to maintain that listing,
Critical Therapeutics must satisfy minimum financial and other
listing requirements.
On April 21, 2008, Critical Therapeutics received
notification from the NASDAQ Listings Qualification Department
that for the prior 30 consecutive business days the bid price of
its common stock on The NASDAQ Global Market had closed below
the minimum $1.00 per share required for continued inclusion
under NASDAQ Marketplace Rule 4450(a)(5). On May 16,
2008, Critical Therapeutics received notification from the
NASDAQ Listings Qualification Department that its
stockholders equity of $7,126,000, as reported in its
Quarterly Report on
Form 10-Q
for the quarter ended March 31, 2008 that it filed with the
SEC, does not comply with the minimum stockholders equity
requirement of $10,000,000 for continued listing on The NASDAQ
Global Market pursuant to NASDAQ Marketplace
Rule 4450(a)(3).
55
On June 13, 2008, NASDAQ approved the transfer of the
listing of Critical Therapeutics common stock from The
NASDAQ Global Market to The NASDAQ Capital Market effective at
the opening of business on June 17, 2008. A condition to
approval of the transfer of the listing was Critical
Therapeutics satisfaction of The NASDAQ Capital
Markets continued listing requirements, other than the
$1.00 per share minimum bid price requirement. Separately, if
Critical Therapeutics meets all of The NASDAQ Capital
Markets initial listing requirements, other than the
minimum bid price requirement, on October 20, 2008, which
is the date that is 180 days following the date Critical
Therapeutics received notification from NASDAQ that it failed to
comply with the minimum bid price requirement, Critical
Therapeutics will have the remainder of an additional 180
calendar day grace period while listed on The NASDAQ Capital
Market to regain compliance with NASDAQs minimum bid price
requirement. There can be no assurance that on
October 20, 2008 Critical Therapeutics will comply
with The NASDAQ Capital Markets initial listing
requirements, including The NASDAQ Capital Markets minimum
stockholders equity requirement.
On August 13, 2008, Critical Therapeutics received
notification from the NASDAQ Listing Qualification Department
that, based on its stockholders equity of
$1.2 million, as reported in its Quarterly Report on
Form 10-Q for the quarter ended June 30, 2008, and a
market value of its common stock as of August 12, 2008 of
$13.0 million, Critical Therapeutics does not comply with
NASDAQ Marketplace Rule 4310(c)(3), which requires it to
have, for continued listing on The NASDAQ Capital Market, a
minimum of $2.5 million in stockholders equity or
market value of listed securities of $35.0 million or
$500,000 of net income from continuing operations for the most
recently completed fiscal year or two of the three most recently
completed fiscal years. As a result, the Listing Qualifications
Staff is reviewing Critical Therapeutics eligibility for
continued listing on The NASDAQ Capital Market. To facilitate
the review, Critical Therapeutics provided to the Listing
Qualifications Staff on September 3, 2008 a definitive
plan, based on completing the proposed merger with Cornerstone,
to achieve and sustain compliance with all NASDAQ Capital
Market listing requirements. If after the conclusion of its
review process the Listing Qualifications Staff determines that
Critical Therapeutics plan does not adequately address the
deficiencies noted, the Staff will provide written notice to
Critical Therapeutics that its common stock will be delisted
from The NASDAQ Capital Market. In such event, Critical
Therapeutics may appeal the Staffs decision to a NASDAQ
Listing Qualifications Panel.
If Critical Therapeutics fails to continue to meet all
applicable listing requirements of The NASDAQ Capital Market and
NASDAQ determines to delist its common stock, an active trading
market for Critical Therapeutics common stock may not be
sustained and the market price of Critical Therapeutics
common stock could decline. If an active trading market for
Critical Therapeutics common stock is not sustained, it
will be difficult for Critical Therapeutics stockholders
to sell shares of Critical Therapeutics common stock
without further depressing the market price of Critical
Therapeutics common stock or at all. A delisting of
Critical Therapeutics common stock also could make it more
difficult for Critical Therapeutics to obtain financing for the
continuation of Critical Therapeutics operations and could
result in the loss of confidence by investors, suppliers and
employees.
Immediately prior to the effective time of the merger, Critical
Therapeutics has agreed to effect a reverse stock split of
Critical Therapeutics common stock such that outstanding
shares of Critical Therapeutics common stock will be
reclassified and combined into a lesser number of shares such
that one share of Critical Therapeutics common stock will
be issued for a specified number of shares, to be mutually
agreed upon by Critical Therapeutics and Cornerstone, which
shall be greater than one and equal to or less than 50, of
outstanding Critical Therapeutics common stock, with the
exact number within the range to be determined by Critical
Therapeutics board of directors prior to the effective
time of the amendment to Critical Therapeutics certificate
of incorporation effecting the reverse stock split and publicly
announced by Critical Therapeutics. The reverse stock split is
necessary so that as of the effective time of the merger
Critical Therapeutics will satisfy the minimum bid price
requirement pursuant to NASDAQs initial listing standards.
56
If
Critical Therapeutics quarterly results of operations
fluctuate, this fluctuation may subject Critical
Therapeutics stock price to volatility, which may cause an
investment in Critical Therapeutics stock to suffer a
decline in value.
Critical Therapeutics quarterly operating results have
fluctuated in the past and are likely to fluctuate in the
future. A number of factors, many of which are not within
Critical Therapeutics control, could subject Critical
Therapeutics operating results and stock price to
volatility, including:
|
|
|
|
|
Critical Therapeutics proposed merger with Cornerstone and
related developments, including the timing thereof;
|
|
|
|
the amount and timing of sales of ZYFLO CR and ZYFLO;
|
|
|
|
the timing of operating expenses, including selling and
marketing expenses and the costs of maintaining a direct sales
force;
|
|
|
|
the availability and timely delivery of a sufficient supply of
ZYFLO CR and ZYFLO;
|
|
|
|
the amount of rebates, discounts and chargebacks to wholesalers,
Medicaid and MCOs related to ZYFLO CR and ZYFLO;
|
|
|
|
the amount and timing of product returns for ZYFLO CR and ZYFLO;
|
|
|
|
achievement of, or the failure to achieve, milestones under
Critical Therapeutics development agreement with
MedImmune, Critical Therapeutics license agreements with
Beckman Coulter and SetPoint and, to the extent applicable,
other licensing and collaboration agreement;
|
|
|
|
the results of ongoing and planned clinical trials of Critical
Therapeutics product candidates;
|
|
|
|
production problems occurring at Critical Therapeutics
third-party manufacturers;
|
|
|
|
the results of regulatory reviews relating to the development or
approval of Critical Therapeutics product
candidates; and
|
|
|
|
general and industry-specific economic conditions that may
affect Critical Therapeutics research and development
expenditures.
|
Due to the possibility of significant fluctuations, Critical
Therapeutics does not believe that quarterly comparisons of
Critical Therapeutics operating results will necessarily
be indicative of Critical Therapeutics future operating
performance. If Critical Therapeutics quarterly operating
results fail to meet the expectations of stock market analysts
and investors, the price of Critical Therapeutics common
stock may decline.
If
significant business or product announcements by Critical
Therapeutics or Critical Therapeutics competitors cause
fluctuations in Critical Therapeutics stock price, an
investment in Critical Therapeutics stock may suffer a
decline in value.
The market price of Critical Therapeutics common stock may
be subject to substantial volatility as a result of
announcements by Critical Therapeutics or other companies in
Critical Therapeutics industry, including Critical
Therapeutics collaborators. Announcements that may subject
the price of Critical Therapeutics common stock to
substantial volatility include announcements regarding:
|
|
|
|
|
developments with respect to Critical Therapeutics
proposed merger with Cornerstone;
|
|
|
|
Critical Therapeutics operating results, including the
amount and timing of sales of ZYFLO CR and ZYFLO;
|
|
|
|
the availability and timely delivery of a sufficient supply of
ZYFLO CR and ZYFLO;
|
|
|
|
Critical Therapeutics licensing and collaboration
agreements and the products or product candidates that are the
subject of those agreements;
|
|
|
|
the results of discovery, preclinical studies and clinical
trials by Critical Therapeutics or Critical Therapeutics
competitors;
|
|
|
|
the acquisition of technologies, product candidates or products
by Critical Therapeutics or Critical Therapeutics
competitors;
|
57
|
|
|
|
|
the development of new technologies, product candidates or
products by Critical Therapeutics or Critical Therapeutics
competitors;
|
|
|
|
regulatory actions with respect to Critical Therapeutics
product candidates or products or those of Critical
Therapeutics competitors; and
|
|
|
|
significant acquisitions, strategic partnerships, joint ventures
or capital commitments by Critical Therapeutics or Critical
Therapeutics competitors.
|
Risks
Relating to Termination of the Merger Agreement or Other Failure
to Consummate the Merger
If the
proposed merger with Cornerstone is not consummated, Critical
Therapeutics business could suffer materially and Critical
Therapeutics stock price could decline.
The consummation of the proposed merger with Cornerstone is
subject to a number of closing conditions, including the
approval by Critical Therapeutics stockholders, approval
by NASDAQ of Critical Therapeutics application for
re-listing of Critical Therapeutics common stock in
connection with the merger, the continued availability of
Critical Therapeutics products and other customary closing
conditions.
If the proposed merger is not consummated, Critical Therapeutics
may be subject to the following risks:
|
|
|
|
|
Critical Therapeutics has incurred and expects to continue to
incur significant expenses related to the proposed merger with
Cornerstone. As of August 31, 2008, Critical Therapeutics
had approximately $1.8 million of fees and expenses billed
and accrued in connection with the proposed merger for legal,
financial advisory, accounting and other services. These fees
and expenses are payable by Critical Therapeutics even if the
merger is not consummated.
|
|
|
|
If the merger agreement is terminated, Critical Therapeutics
will have a limited ability to continue its current operations
without obtaining additional financing to fund its operations.
|
|
|
|
Critical Therapeutics could be obligated to pay Cornerstone a
$1.0 million termination fee and to reimburse Cornerstone
for up to $150,000 in expenses in connection with the
termination of the merger agreement, depending on the reason for
the termination. Critical Therapeutics would not be obligated to
pay Cornerstone the $1.0 million termination fee if
Critical Therapeutics stockholders fail to approve the
proposals presented at the special meeting unless at or prior to
the time of such failure an acquisition proposal relating to
Critical Therapeutics was announced and was not abandoned or
withdrawn.
|
|
|
|
Critical Therapeutics customers, prospective customers,
collaborators and other business partners and investors in
general may view the failure to consummate the merger as a poor
reflection on its business or prospects.
|
|
|
|
The market price of Critical Therapeutics common stock may
decline further to the extent that the current market price
reflects a market assumption that the proposed merger will be
completed.
|
In addition, if the merger agreement is terminated and Critical
Therapeutics board of directors determines to seek another
business combination, it may not be able to find a third party
willing to provide equivalent or more attractive consideration
than the consideration to be provided by each party in the
merger. In such circumstances, Critical Therapeutics board
of directors may elect to, among other things, divest all or a
portion of Critical Therapeutics business, or take the
steps necessary to liquidate all of Critical Therapeutics
business and assets, and in either such case, the consideration
that Critical Therapeutics receives may be less attractive than
the consideration to be received by Critical Therapeutics
pursuant to the merger agreement.
If the
Delaware Court of Chancery enjoins Critical Therapeutics from
proceeding with the merger, Critical Therapeutics will have a
limited ability to continue its current operations if a third
party is unwilling to provide equivalent or more attractive
consideration than proposed in connection with the proposed
merger with Cornerstone.
On September 17, 2008, a purported shareholder class action
lawsuit was filed by a single plaintiff against Critical
Therapeutics and each of its directors in the Court of Chancery
of The State of Delaware. The complaint alleges, among other
things, that the defendants breached fiduciary duties of loyalty
and good faith,
58
including a fiduciary duty of candor, by failing to provide
Critical Therapeutics stockholders with a proxy
statement/prospectus adequate to enable them to cast an informed
vote on the proposed merger, and by possibly failing to maximize
stockholder value by entering into an agreement that effectively
discourages competing offers. The complaint seeks, among other
things, an order (i) enjoining the defendants from
proceeding with or implementing the proposed merger on the terms
and under the circumstances as they presently exist,
(ii) invalidating the provisions of the proposed merger
that purportedly improperly limit the effective exercise of the
defendants continuing fiduciary duties;
(iii) ordering defendants to explore alternatives and to
negotiate in good faith with all bona fide interested
parties; (iv) in the event the proposed merger is
consummated, rescinding it and setting it aside or awarding
rescissory damages; (v) awarding compensatory damages
against defendants, jointly and severally; and
(vi) awarding the plaintiff and the purported class their
costs and fees.
If the Court of Chancery enjoins Critical Therapeutics from
proceeding with the merger and the merger is not consummated,
Critical Therapeutics may be subject to each of the risks
described in the immediately preceding risk factor. In
particular, if the proposed merger with Cornerstone is not
consummated, Critical Therapeutics will have a limited ability
to continue its current operations without obtaining additional
financing. If Critical Therapeutics board of directors
determines to seek another business combination, it may not be
able to find a third party willing to provide equivalent or more
attractive consideration than the consideration to be provided
by each party in the merger. In addition, defending against the
lawsuit will be costly and time consuming for Critical
Therapeutics and may distract Critical Therapeutics
management from day to day operations. If the lawsuit is
successful, Critical Therapeutics could be required to pay
monetary damages and the plaintiffs costs and fees.
Risks
Related to Cornerstone
Risks
Relating to Commercialization and Acquisitions
Cornerstone
has derived substantially all of its revenues from sales of the
ALLERX Dose Pack products, SPECTRACEF and BALACET
325.
Cornerstone has derived and expects for the foreseeable future
to continue to derive substantially all of its revenues from
sales of
AlleRx®,
or ALLERX, Dose Pack products,
Spectracef®
(cefditoren pivoxil), or SPECTRACEF, and
Balacet®
325 (propoxyphene napsylate and acetaminophen), or BALACET 325.
If commercial, regulatory or other developments adversely affect
Cornerstones ability to market these products or if demand
for these products is reduced, Cornerstones business,
financial condition and operating results could be materially
harmed. Until one or more of Cornerstones product
candidates receive FDA approval and is successfully
commercialized, the success of Cornerstones business and
its operating results will depend substantially on the demand
for and continued marketability of the ALLERX Dose Pack
products, SPECTRACEF and BALACET 325.
The
commercial success of Cornerstones currently marketed
products and any additional products that it successfully
develops depends and will depend on the degree of market
acceptance by physicians, patients, health care payors and
others in the medical community.
Any products that Cornerstone brings to the market may not gain
market acceptance by physicians, patients, health care payors
and others in the medical community. If its products do not
achieve an adequate level of acceptance, Cornerstone may not
generate significant product revenue and may not become
profitable. The degree of market acceptance of
Cornerstones products, including its product candidates,
if approved for commercial sale, will depend on a number of
factors, including:
|
|
|
|
|
the prevalence and severity of the products side effects;
|
|
|
|
the efficacy and potential advantages of the products over
alternative treatments;
|
|
|
|
the ability to offer the products for sale at competitive
prices, including in relation to any generic or re-imported
products or competing treatments;
|
|
|
|
the relative convenience and ease of administration of the
products;
|
59
|
|
|
|
|
the willingness of the target patient population to try new
therapies and of physicians to prescribe these therapies;
|
|
|
|
the perception by physicians and other members of the health
care community of the safety and efficacy of the products and
competing products;
|
|
|
|
the availability and level of third-party reimbursement for
sales of the products;
|
|
|
|
the continued availability of adequate supplies of the products
to meet demand;
|
|
|
|
the strength of marketing and distribution support;
|
|
|
|
any unfavorable publicity concerning Cornerstone, its products
or the markets for these products, such as information
concerning product contamination or other safety issues in the
markets for Cornerstones products, whether or not directly
involving Cornerstones products;
|
|
|
|
regulatory developments related to Cornerstones marketing
and promotional practices or the manufacture or continued use of
its products; and
|
|
|
|
changes in intellectual property protection available for the
products or competing treatments.
|
For example, SPECTRACEF and the SPECTRACEF line extensions are
indicated for the treatment of respiratory infections. Products
used to treat respiratory infections are, from time to time,
subject to negative publicity, including with respect to
antibiotic resistance and overuse.
Concerns
regarding the potential toxicity and addictiveness of
propoxyphene and the known liver toxicity of acetaminophen may
limit market acceptance of BALACET 325, APAP 325 and APAP 500 or
cause the FDA to remove these products from the
market.
Periodically, there is negative publicity related to the
potential toxicity and addictiveness of propoxyphene.
Propoxyphene is one of two active pharmaceutical ingredients,
together with acetaminophen, in BALACET 325,
Propoxyphene-APAP 100-325,
or APAP 325, and Propoxyphene-APAP
100-500, or
APAP 500. For example, the consumer advocacy organization Public
Citizen filed suit in June 2008 against the FDA based on the
FDAs failure to act on Public Citizens February 2006
citizen petition that had requested that the FDA immediately
begin the phased removal of all drugs containing propoxyphene
from the marketplace based on propoxyphenes toxicity
relative to its efficacy and its tendency to induce
psychological and physical dependence. Although Cornerstone is
not a party to this proceeding, if the FDA granted the citizen
petition and began the phased removal of propoxyphene from the
market, product sales of BALACET 325, APAP 325 and APAP 500
would be eliminated and Cornerstone would likely be forced to
terminate its co-promotion agreement with Atley Pharmaceuticals,
Inc., or Atley Pharmaceuticals.
In December 2006, the FDA recognized concerns about the known
liver toxicity of over-the-counter pain relievers, including
acetaminophen, which is found in BALACET 325, APAP 325 and
APAP 500. The FDA could act on these concerns by changing its
policies with respect to acetaminophen and opioid combination
products. Any such future policy change could adversely affect
Cornerstones ability to market BALACET 325, APAP 325
and APAP 500.
Cornerstones
strategy of obtaining, through acquisitions and in-licenses,
rights to products and product candidates for its development
pipeline and to proprietary drug delivery and formulation
technologies for its life cycle management of current products
may not be successful.
Part of Cornerstones business strategy is to acquire
rights to FDA-approved products, pharmaceutical product
candidates in the late stages of development and proprietary
drug delivery and formulation technologies. Because Cornerstone
does not have discovery and research capabilities, the growth of
its business will depend in significant part on its ability to
acquire or in-license additional products, product candidates or
proprietary drug delivery and formulation technologies that it
believes have significant commercial potential and are
consistent with its commercial objectives. However, it may be
unable to license or acquire suitable products, product
candidates or technologies from third parties for a number of
reasons. Cornerstone has limited resources to acquire
third-party products, product candidates and technologies and
integrate them into its current infrastructure. The licensing
and acquisition of pharmaceutical products, product candidates
and related technologies is a competitive area, and a number of
more established companies are also pursuing strategies to
60
license or acquire products, product candidates and drug
delivery and formulation technologies, which may mean fewer
suitable acquisition opportunities for Cornerstone, as well as
higher acquisition prices. Many of Cornerstones
competitors have a competitive advantage over Cornerstone due to
their size, cash resources and greater clinical development and
commercialization capabilities. Other factors that may prevent
Cornerstone from licensing or otherwise acquiring suitable
products, product candidates or technologies include:
|
|
|
|
|
Cornerstone may be unable to license or acquire the relevant
products, product candidates or technologies on terms that would
allow it to make an appropriate return on investment;
|
|
|
|
companies that perceive Cornerstone as a competitor may be
unwilling to assign or license their product rights or
technologies to it;
|
|
|
|
Cornerstone may be unable to identify suitable products, product
candidates or technologies within its areas of
expertise; and
|
|
|
|
Cornerstone may have inadequate cash resources or may be unable
to obtain financing to acquire rights to suitable products,
product candidates or technologies from third parties.
|
If Cornerstone is unable to successfully identify and acquire
rights to products, product candidates and proprietary drug
delivery and formulation technologies and successfully integrate
them into its operations, it may not be able to increase its
revenues in future periods, which could result in significant
harm to its financial condition, results of operations and
prospects. Cornerstone is not currently actively engaged in any
discussions with any person regarding the acquisition of rights
to products, product candidates or drug delivery and formulation
technologies that have advanced to a binding term sheet or
similar stage.
If
Cornerstone is unable to expand its sales force and marketing
capabilities, the commercial opportunity for its products and
product candidates may be diminished.
Cornerstone has built a commercial organization, consisting of
its sales department, including its sales force, sales
management, sales logistics and sales administration, and its
marketing department, that currently focuses on marketing and
promoting Cornerstones SPECTRACEF and the ALLERX Dose Pack
products. As of September 15, 2008, this organization
included a respiratory-focused sales team made up of 49 sales
representatives that calls on primary care physicians,
allergists, otolaryngologists, pulmonologists, infectious
disease specialists, physician assistants, nurse practitioners
and pharmacists. However, to date Cornerstone has not
commercialized a newly approved product. Cornerstone plans to
recruit additional sales professionals to expand its specialty
sales force as it prepares for the commercial launch of
SPECTRACEF Suspension, subject to FDA approval. If Cornerstone
successfully completes development and receives FDA approval of
its methscopolamine and antihistamine combination product
candidate, it expects to further expand its specialty sales
force to promote this additional product. In addition,
Cornerstone currently is in the process of expanding its
marketing team to prepare for the potential commercial launch of
these product candidates.
Cornerstone previously conducted reductions in force in each of
January 2006 and April 2008, which may negatively affect its
ability to attract and retain additional sales and marketing
personnel. Cornerstone may not be able to attract, hire, train
and retain qualified sales and marketing personnel to augment
its existing capabilities in the manner or on the timeframe that
it is currently planning. If Cornerstone is not successful in
its efforts to expand its sales force and marketing
capabilities, its ability to independently market and promote
any product candidates that it successfully brings to market
will be impaired. In such an event, Cornerstone would likely
need to establish a collaboration, co-promotion, distribution or
other similar arrangement to market and sell the product
candidate. However, Cornerstone might not be able to enter into
such an arrangement on favorable terms, if at all.
Expanding Cornerstones sales force and marketing group
will be expensive and time consuming and could delay a product
launch. Companies such as Cornerstone typically expand their
sales force and marketing capabilities for a product prior to it
being approved by the FDA so that the drug can be commercialized
upon approval. If the commercial launch of a product candidate
for which Cornerstone recruits a sales force and establishes
marketing capabilities is delayed as a result of FDA
requirements or other reasons, Cornerstone would incur the
expense of the additional sales and marketing personnel prior to
being able to realize any revenue from the sales of the product
candidate. This may be costly, and Cornerstones investment
would be lost if it cannot retain its sales and marketing
personnel. Even if Cornerstone is able to effectively expand its
61
sales force and marketing capabilities, its sales force and
marketing teams may not be successful in commercializing its
products.
Cornerstone
faces competition, which may result in others discovering,
developing or commercializing products before or more
successfully than Cornerstone.
The development and commercialization of drugs is highly
competitive. Cornerstone faces competition with respect to its
currently marketed products, its current product candidates and
any products it may seek to develop or commercialize in the
future. Cornerstones competitors include major
pharmaceutical companies, specialty pharmaceutical companies and
biotechnology companies worldwide. Potential competitors also
include academic institutions, government agencies and other
private and public research organizations that seek patent
protection and establish collaborative arrangements for
development, manufacturing and commercialization. Cornerstone
faces significant competition for its currently marketed
products. Some of its currently marketed products do not have
patent protection and in most cases face generic competition.
All of these products face significant price competition from a
range of branded and generic products for the same therapeutic
indications.
Given that Cornerstones product development approach is to
develop new formulations of existing drugs, some or all of its
product candidates, if approved, may face competition from
generic and branded formulations of these existing drugs, as
well as significant price competition. Cornerstones
product candidates, if approved, will compete with other branded
and generic drugs approved for the same therapeutic indications,
approved drugs used off label for such indications and novel
drugs in clinical development. For example, Cornerstones
methscopolamine/antihistamine product candidate, which is a
modified formulation of an existing product, may not demonstrate
sufficient additional clinical benefits to physicians to justify
a higher price compared to generic equivalents within the same
therapeutic class. Cornerstones commercial opportunity
could be reduced or eliminated if its competitors develop and
commercialize products that are more effective, safer, have
fewer or less severe side effects, are more convenient or are
less expensive than any products that Cornerstone may develop.
Cornerstones patents will not protect its products if
competitors devise ways of making products that compete with
Cornerstones products without legally infringing its
patents. The FDCA and FDA regulations and policies provide
incentives to manufacturers to create modified, non-infringing
versions of a drug in order to facilitate the approval of
abbreviated NDAs, or ANDAs, for generic substitutes. These same
types of incentives encourage manufacturers to submit NDAs that
rely, in part, on literature and clinical data not prepared for
or by such manufacturers. Manufacturers might only be required
to conduct a relatively inexpensive study to show that their
product has the same API, dosage form, strength, route of
administration and conditions of use or labeling as
Cornerstones product and that the generic product is
absorbed in the body at the same rate and to the same extent as
Cornerstones product, a comparison known as
bioequivalence. Such products would be significantly less costly
than Cornerstones products to bring to market and could
lead to the existence of multiple lower-priced competitive
products, which would substantially limit Cornerstones
ability to obtain a return on the investments it has made in
those products.
Cornerstones competitors also may obtain FDA or other
regulatory approval for their product candidates more rapidly
than Cornerstone may obtain approval for its product candidates.
Federal law provides for a period of three years of exclusivity
following approval of a listed drug that contains previously
approved active pharmaceutical ingredients but is approved in a
new dosage strength, dosage form, route of administration or
combination, or for a new use, the approval of which was
required to be supported by new clinical trials conducted by or
for the sponsor. During such three-year exclusivity period, the
FDA cannot grant effective approval of an ANDA or a Section
505(b)(2) NDA to commercially distribute a version of the drug
based on that listed drug. Federal law also provides a five-year
period of exclusivity following approval of a drug containing no
previously approved active pharmaceutical ingredients. If a
Cornerstone competitor obtains approval of a product that uses
the same API for the same indication as a Cornerstone product
candidate, Cornerstone would not be able to receive FDA approval
of its product candidate until the applicable exclusivity period
had expired.
62
Cornerstones products compete, and its product candidates,
if approved, will compete, principally with the following:
|
|
|
|
|
SPECTRACEF, SPECTRACEF 400 mg and SPECTRACEF Once
Daily second and third generation
cephalosporins, such as Shionogi USA, Inc.s
Cedax®
(ceftibuten), Lupin Pharmaceuticals, Inc.s, or Lupin
Pharmaceuticals,
Suprax®
(cefixime) and generic formulations of Abbott Laboratories,
Inc.s
Omnicef®
(cefdinir), Pharmacia and Upjohn Company, Inc.s
Vantin®
(cefpodoxime), GlaxoSmithKline plcs
Ceftin®
(cefuroxime) and
Bristol-Myers
Squibb Companys
Cefzil®
(cefprozil); macrolides, such as generic formulations of
Pfizer Inc.s
Zithromax®
(azithromycin) and Abbott Laboratories, Inc.s
Biaxin®
(clarithromycin); and quinolones, such as Ortho-McNeil-Janssen
Pharmaceuticals, Inc.s
Levaquin®
(levofloxacin) and generic formulations of Bayer AGs
Cipro®
(ciprofloxacin).
|
|
|
|
SPECTRACEF Suspension Suprax and generic
formulations of Omnicef and Ceftin.
|
|
|
|
ALLERX and
RespiVenttm,
or RESPIVENT, Dose Pack Products prescription
products, including first generation antihistamine and
antihistamine combination products, such as Capellon
Pharmaceuticals, Ltd.s
Rescon-MX®
(chlorpheniramine, methscopolamine and phenylephrine), Poly
Pharmaceuticals, Inc.s Poly Hist
Forte®
(chlorpheniramine, phenylephrine and pyrilamine) and Laser
Pharmaceuticals, LLCs
Dallergy®
(phenylephrine, chlorpheniramine and methscopolamine); and
over-the-counter products, such as McNeil PPC, Inc.s
Zyrtec®
(cetirizine), Schering-Plough Corporations
Claritin®
(loratadine) and
Chlor-Trimeton®
(chlorpheniramine) and McNeil PPC, Inc.s
Benadryl®
(diphenhydramine).
|
|
|
|
BALACET 325, APAP 325 and APAP 500
generic formulations of propoxyphene and acetaminophen, the
active pharmaceutical ingredients in BALACET 325, APAP 325
and APAP 500, and many other drugs on the market or in
development for the treatment of mild to moderate pain.
|
|
|
|
Hyomaxtm,
or HYOMAX, Products belladonna and derivative
antispasmodics, such as the generic formulations of Alaven
Pharmaceutical LLCs
Levsin®
(hyoscyamine sulfate) and
Levbid®
(hyoscyamine sulfate); synthetic gastrointestinal
antispasmodics, such as the generic formulations of Axcan Pharma
Inc.s
Bentyl®
(dicyclomine) and Kenwood Therapeutics
Pamine®
(methscopolamine bromide).
|
|
|
|
Methscopolamine and Antihistamine Combination Product
Candidate second generation antihistamines, such
as Sanofi-Aventis U.S. LLCs
Allegra®
(fexofenadine); third generation antihistamines, such as UCB,
Inc. and Sanofi-Aventis U.S. LLCs
Xyzal®
(levocetirizine) and Schering-Plough Corporations
Clarinex®
(desloratadine); first generation antihistamine combination
products, which are mostly generic; and over-the-counter
antihistamines, such as Claritin, Zyrtec, Benadryl and
Chlor-Trimeton.
|
|
|
|
Hydrocodone Cough Suppressant Product Candidates
Endo Pharmaceuticals
Hycodan®
(hydrocodone) and King Pharmaceuticals
Tussigon®
(hydrocodone and homatropine), Mallinckrodt Medical Inc.s
TussiCaps®
(hydrocodone polistirex and chlorpheniramine polistirex) and UCB
Pharmas
Tussionex®
(hydrocodone polistirex and chlorpheniramine polistirex);
over-the-counter cough suppressants, such as Reckitt
Benckisers
Delsym®
(dextromethorphan polistirex),
Wyeths Robitussin-DM®
(dextromethorphan and guaifenesin) and Procter &
Gamble Companys Vicks Formula
44®
Cough Relief (dextromethorphan, phenylephrine and
chlorpheniramine); and prescription cough suppressants, such as
Sciele Pharma, Inc.s
Rondec®
DM Syrup (chlorpheniramine, phenylephrine and dextromethorphan)
and Meda Pharmaceuticals Inc.s
Tussi-12D®
(carbetapentane, pyrilamine and phenylephrine).
|
Many of Cornerstones competitors may have significantly
greater financial resources and expertise in research and
development, manufacturing, preclinical testing, conducting
clinical trials, obtaining regulatory approvals and marketing
approved products than it does. These competitors also compete
with Cornerstone in recruiting and retaining qualified
scientific and management personnel, establishing clinical trial
sites, registering patients for clinical trials and acquiring
technologies complementary to, or necessary for, its programs or
advantageous to its business. In many cases, products that
compete with Cornerstones currently marketed products and
product candidates have well known brand names, are distributed
by large pharmaceutical companies with substantial resources and
have achieved widespread acceptance among physicians and
patients. Smaller or early stage companies may also prove to be
significant competitors, particularly through collaborative
arrangements with large and established companies.
63
As its
competitors introduce their own generic equivalents of
Cornerstones generic products, Cornerstones net
revenues from such products are expected to
decline.
Product sales of generic pharmaceutical products often follow a
particular pattern over time based on regulatory and competitive
factors. The first company to introduce a generic equivalent of
a branded product is often able to capture a substantial share
of the market. However, as other companies introduce competing
generic products, the first entrants market share, and the
price of its generic product, will typically decline. The extent
of the decline generally depends on several factors, including
the number of competitors, the price of the branded product and
the pricing strategy of the new competitors. Cornerstones
inability to introduce additional generic products or its
withdrawal of its existing generic products from the market due
to increased competition would have a material adverse effect on
its financial condition and results of operations.
For example, in the generic drug industry, when a company is the
first to introduce a generic drug, the pricing of the generic
drug is typically set based on the published price of the
equivalent brand product. Other generic manufacturers may enter
the market and, as a result, the price of the drug may decline
significantly. In such event, Cornerstone may in its discretion
provide its customers a credit with respect to the
customers remaining inventory for the difference between
Cornerstones new price and the price at which Cornerstone
originally sold the product to its customers. There are
circumstances under which Cornerstone may, as a matter of
business strategy, not provide price adjustments to certain
customers and, consequently, may lose future sales to
competitors.
If
Cornerstone fails to successfully manage its acquisitions, its
ability to develop its product candidates and expand its product
pipeline may be harmed.
Cornerstones failure to adequately address the financial,
operational or legal risks of its acquisitions or
in-license
arrangements could harm its business. These risks include:
|
|
|
|
|
the overuse of cash resources;
|
|
|
|
higher than anticipated acquisition costs and expenses;
|
|
|
|
potentially dilutive issuances of equity securities;
|
|
|
|
the incurrence of debt and contingent liabilities, impairment
losses
and/or
restructuring charges;
|
|
|
|
the assumption of or exposure to unknown liabilities;
|
|
|
|
the development and integration of new products that could
disrupt Cornerstones business and occupy its
managements time and attention;
|
|
|
|
the inability to preserve key suppliers or distributors of any
acquired products; and
|
|
|
|
the acquisition of products that could substantially increase
its amortization expenses.
|
If Cornerstone is unable to successfully manage its
acquisitions, its ability to develop new products and continue
to expand its product pipeline may be limited, and it could
suffer significant harm to its financial condition, results of
operations and prospects.
Cornerstone
may experience significant inventory losses related to at
risk generic product launches, which could have a material
adverse effect on Cornerstones business, financial
position and results of operations.
There are situations in which Cornerstone may make business and
legal judgments to market and sell generic products that are
subject to claims of alleged patent infringement prior to final
resolution of those claims by the courts, based upon its belief
that such patents are invalid, unenforceable or would not be
infringed. This practice is referred to in the pharmaceutical
industry as an at risk launch. The risk involved in
an at risk launch can be substantial because, if the patent
holder ultimately prevails, the remedies available to the holder
may include, among other things, damages measured by the profits
lost by the holder, which can be significantly higher than the
actual profits Cornerstone made from selling the generic version
of the product. Cornerstone would also be at risk for the value
of the inventory that it is unable to sell.
64
A
failure to maintain optimal inventory levels could harm
Cornerstones reputation and subject it to financial
losses.
Cornerstone is subject to minimum purchase obligations under its
supply agreement with Meiji Seika Kaisha, Ltd., or Meiji, for
the purchase of SPECTRACEF 200 mg and SPECTRACEF 400 mg. Under
the agreement, the annual targeted gross sales of SPECTRACEF are
$15.0 million for the first year beginning with the commercial
launch of SPECTRACEF 200 mg or SPECTRACEF 400 mg manufactured by
Meiji, whichever is earlier, $20.0 million for year two,
$25.0 million for year three, $30.0 million for year
four and $35.0 million for year five. If Cornerstone does
not meet its minimum purchase requirement in a given year,
Cornerstone must pay Meiji an amount equal to 50% of the
shortfall in that year. If SPECTRACEF does not achieve the level
of sales Cornerstone anticipates, Cornerstone may not be able to
use all of the cefditoren pivoxil it is required to purchase.
Cornerstone is using its current inventory of cefditoren pivoxil
for formulation, development and manufacture of the currently
marketed SPECTRACEF product as well as the SPECTRACEF line
extensions.
Cornerstone is subject to minimum purchase obligations under its
manufacturing agreement with Bayer Healthcare, LLC, or Bayer,
for the purchase of bulk tablets for the ALLERX product line.
Under the agreement, Cornerstone has a minimum annual purchase
requirement of 27.0 million tablets per year for 2008
and 2009. If there are changes to the market that negatively
impact the demand for ALLERX, Cornerstone would be required to
pay Bayer a variable amount up to $135,000 based on the
extent to which Cornerstone did not fulfill it minimum purchase
obligations.
Because accurate product planning is necessary to ensure that
Cornerstone maintains optimal inventory levels, significant
differences between Cornerstones current estimates and
judgments and future estimated demand for its products and the
useful life of inventory may result in significant charges for
excess inventory or purchase commitments in the future. If
Cornerstone is required to recognize charges for excess
inventories, such charges could have a material adverse effect
on its financial condition and results of operations. Due to
significant differences between Cornerstones sales
forecasts and the actual demand for SPECTRACEF, Cornerstone
currently has more SPECTRACEF inventory on hand than is
necessary to meet forecasted demand. Although the current
SPECTRACEF inventory has a
26-month
shelf life, if demand does not meet or exceed Cornerstones
forecast over the next 20 months, Cornerstone may be
required to take a charge against its reserves for obsolete
inventory.
Cornerstones ability to maintain optimal inventory levels
also depends on the performance of its third-party contract
manufacturers. If Cornerstone is unable to manufacture and
release its inventory on a timely and consistent basis, if it
fails to maintain an adequate level of product inventory, if its
inventory is destroyed or damaged or if its inventory reaches
its expiration date, patients might not have access to its
products, Cornerstones reputation and its brands could be
harmed and physicians may be less likely to prescribe
Cornerstones products in the future, each of which could
have a material adverse effect on Cornerstones financial
condition, results of operations and cash flows.
If
Cornerstones third-party manufacturers and packagers do
not obtain the necessary quota for procurement of controlled
substances needed to supply it with its currently marketed
products or the quotas are not sufficient, Cornerstone may be
unable to meet commercial demand for the products.
ALLERX 10 Dose Pack, ALLERX 30 Dose Pack, ALLERX-D and
RESPIVENT-D
contain pseudoephedrine, and BALACET 325, APAP 325 and APAP
500 contain propoxyphene, each of which are active
pharmaceutical ingredients that are regulated by the
U.S. Drug Enforcement Administration, or DEA, under the
Controlled Substances Act and are subject to annual
manufacturing quotas established by the DEA. Cornerstone depends
on Bayer and Sovereign, the manufacturers of bulk tablets for
ALLERX 10 Dose Pack, ALLERX 30 Dose Pack,
ALLERX-D and
RESPIVENT-D,
Legacy Pharmaceutical Packaging, LLC, or Legacy, and Carton
Service, Inc., or Carton Service, the manufacturers of trade and
sample packaging for ALLERX 10 Dose Pack, ALLERX 30
Dose Pack,
ALLERX-D and
RESPIVENT-D, and Vintage Pharmaceuticals, LLC, or Vintage, the
manufacturer of BALACET 325, APAP 325 and
APAP 500, to obtain the necessary quotas from the DEA to
procure active pharmaceutical ingredients and to supply and
package finished product to meet its demand. The DEA requires
substantial evidence and documentation of expected legitimate
medical and scientific needs before assigning quotas to
manufacturers. Although Cornerstone has adopted a production
planning program in an effort to
65
minimize the risks associated with shortages of these products,
unexpected market requirements or problems with third-party
facilities, among other factors, could result in shortages of
one or more of these products. If Cornerstones commercial
requirements of its products exceed the applicable DEA quotas,
its suppliers and contract manufacturers would need to apply to
the DEA for a quota adjustment. The DEA has substantial
discretion in determining whether to make any such adjustment
and may decide not to do so. In addition, Cornerstone is subject
to strict regulatory restrictions on its handling, sale and
distribution of its controlled substance products, including
security, recordkeeping and reporting obligations enforced by
the DEA. Cornerstones failure to comply with these
requirements could result in the loss of its DEA registration,
significant restrictions on its controlled substance products,
civil penalties or criminal prosecution.
Product
liability lawsuits against Cornerstone could cause it to incur
substantial liabilities and to limit commercialization of any
products that it may develop.
Cornerstone faces an inherent risk of product liability exposure
related to the sale of its currently marketed products, any
other products that it successfully develops and the testing of
its product candidates in human clinical trials. If Cornerstone
cannot successfully defend itself against claims that its
products or product candidates caused injuries, it will incur
substantial liabilities. Regardless of merit or eventual
outcome, liability claims may result in:
|
|
|
|
|
decreased demand for Cornerstones products or any products
that it may develop;
|
|
|
|
injury to Cornerstones reputation;
|
|
|
|
the withdrawal of clinical trial participants;
|
|
|
|
the withdrawal of a product from the market;
|
|
|
|
costs to defend the related litigation;
|
|
|
|
substantial monetary awards to clinical trial participants or
patients;
|
|
|
|
diversion of management time and attention;
|
|
|
|
loss of revenue; and
|
|
|
|
Cornerstones inability to commercialize the products that
it may develop.
|
For example, Cornerstone could face product liability exposure
related to the potential toxicity and addictiveness of
propoxyphene. Propoxyphene is one of two active pharmaceutical
ingredients, together with acetaminophen, in BALACET 325,
APAP 325 and APAP 500. The consumer advocacy organization
Public Citizen filed suit in June 2008 against the FDA based on
the FDAs failure to act on Public Citizens February
2006 citizen petition that had requested that the FDA
immediately begin the phased removal of all drugs containing
propoxyphene from the marketplace based on propoxyphenes
toxicity relative to its efficacy and its tendency to induce
psychological and physical dependence. In addition, in December
2006, the FDA recognized concerns about the known liver toxicity
of over-the-counter pain relievers, including acetaminophen,
which is found in BALACET 325, APAP 325 and
APAP 500. While Cornerstone is not aware of any pending or
threatened product liability claims against Cornerstone related
to propxyphene or acetaminophen, there can be no assurance that
such claims will not arise in the future.
Cornerstones contracts with wholesalers and other
customers require it to carry product liability insurance.
Cornerstone has product liability insurance coverage with a
$5 million annual aggregate limit and a $5 million
individual claim limit, and which is subject to a per claim
deductible and a policy aggregate deductible. The annual cost of
this products liability insurance was approximately $138,000 for
the policy year beginning September 13, 2007. The amount of
insurance that it currently holds may not be adequate to cover
all liabilities that it may incur. Insurance coverage is
increasingly expensive. Cornerstone may not be able to maintain
insurance coverage at a reasonable cost and may not be able to
obtain insurance coverage that will be adequate to satisfy any
liability that may arise.
66
Risks
Relating to Product Development and Regulatory Matters
If
Cornerstone is unable to develop safe and efficacious
formulations of its product candidates, or its clinical trials
for the SPECTRACEF Suspension line extension or its other
product candidates are not successful, it may not be able to
develop, obtain regulatory approval for and commercialize these
product candidates successfully.
Cornerstones product candidates are still in various
stages of development. Cornerstones product development
pipeline includes the following three SPECTRACEF line
extensions: SPECTRACEF 400 mg, a 400 mg dose tablet;
SPECTRACEF Once Daily, a once daily dosage tablet; and
SPECTRACEF Suspension, an oral suspension for the pediatric
market. Cornerstones product development pipeline also
includes the following three additional product candidates:
CBP 058, a methscopolamine and antihistamine combination
product candidate for the treatment of symptoms of allergic
rhinitis; CBP 067, an extended-release antitussive, or
cough suppressant, combination product candidate; and
CBP 069, also an extended-release antitussive combination
product candidate. Except for SPECTRACEF 400 mg, for
which the FDA approved Cornerstones supplemental new drug
application, or sNDA, in July 2008 all of Cornerstones
product candidates remain subject to pharmaceutical formulation
development and clinical testing necessary to obtain the
regulatory approvals or clearances required for commercial sale.
Depending on the nature of the product candidate, to demonstrate
a product candidates safety and efficacy, Cornerstone and
its collaborators generally must either demonstrate
bioequivalence with a drug already approved by the FDA or
complete human clinical trials. Cornerstone may not be able to
obtain permission from the FDA, institutional review boards, or
IRBs, or other authorities to commence or complete necessary
clinical trials. If permitted, such clinical testing may not
prove that Cornerstones product candidates are safe and
effective to the extent necessary to permit it to obtain
marketing approvals or clearances from regulatory authorities.
One or more of its product candidates may not exhibit the
expected therapeutic results in humans, may cause harmful side
effects or may have other unexpected characteristics that may
delay or preclude submission and regulatory approval or
clearance or limit commercial use if approved or cleared. For
example, Cornerstones cough suppressant product
candidates, CBP 067 and CBP 069, contain hydrocodone, which has
been associated with abuse and can lead to serious illness,
injury or death if improperly used. Furthermore, Cornerstone,
one of its collaborators, IRBs or regulatory agencies may order
a clinical hold or suspend or terminate clinical trials at any
time if it is believed that the subjects or patients
participating in such trials are being exposed to unacceptable
health risks or for other reasons.
For example, Guidance for Industry issued by the FDA in 2007
regarding, among other things, the design of clinical trials of
drug candidates for the treatment of acute bacterial otitis
media, noted that investigators or IRBs may consider a
placebo-controlled study to be unethical where the trial would
involve the withholding of known effective antimicrobial
treatment to the placebo control group unless the investigators
and IRBs determine that the withholding of known effective
treatment would result in no more than a minor increase over
minimal risk. The FDA suggested that the ethical dilemma might
be bridged by using a superiority study of the investigational
antimicrobial compared to a known effective antimicrobial
treatment. While the FDA did not absolutely prohibit
placebo-controlled trials in such cases, Cornerstone believes
this FDA guidance may make placebo-controlled trials more
difficult to design and complete, especially in pediatric
populations.
Adverse or inconclusive clinical trial results concerning any of
Cornerstones product candidates could require it to
conduct additional clinical trials, result in increased costs
and significantly delay the submission for marketing approval or
clearance for such product candidates with the FDA or other
regulatory authorities or result in failure to obtain approval
or approval for a narrower indication. If clinical trials fail,
Cornerstones product candidates would not receive
regulatory approval or achieve commercial viability.
If
clinical trials for Cornerstones product candidates are
delayed, Cornerstone would be unable to obtain regulatory
approval and commercialize its product candidates on a timely
basis, which would require it to incur additional costs and
delay the receipt of any revenues from product
sales.
Cornerstone currently expects to commence a clinical trial with
respect to SPECTRACEF Once Daily in the fourth quarter of 2008,
SPECTRACEF Suspension in 2009 for acute otitis media, its
methscopolamine/antihistamine product candidate CBP 058 in
the first quarter of 2009 and its hydrocodone cough suppressant
product candidates CBP 067 and CBP 069 in 2009.
Cornerstone cannot predict whether it will encounter
67
problems with any of its completed or planned clinical trials
that will delay or cause regulatory authorities, IRBs or
Cornerstone to suspend those clinical trials or the analysis of
data from such trials.
Any of the following could delay the completion of
Cornerstones planned clinical trials:
|
|
|
|
|
discussions with the FDA regarding the scope or design of its
clinical trials;
|
|
|
|
delay in obtaining, or the inability to obtain, required
approvals from regulators, IRBs or other governing entities at
clinical sites selected for participation in its clinical trials;
|
|
|
|
the number of patients required for its clinical trials may be
larger than it anticipates, enrollment in its clinical trials
may be slower than it anticipates or participants may drop out
of its clinical trials at a higher rate than it anticipates;
|
|
|
|
lower than anticipated retention rates of patients and
volunteers in clinical trials;
|
|
|
|
its clinical trials may produce negative or inconclusive
results, and it may decide, or regulators may require it, to
conduct additional clinical trials, or it may abandon projects
that had appeared to be promising;
|
|
|
|
its third-party contractors may fail to comply with regulatory
requirements or meet their contractual obligations in a timely
manner;
|
|
|
|
insufficient supply or deficient quality of product candidate
materials or other materials necessary to conduct its clinical
trials;
|
|
|
|
unfavorable FDA inspection and review of a clinical trial site
or records of any clinical investigation;
|
|
|
|
serious and unexpected drug-related side effects experienced by
participants in past clinical trials for the same or a different
indication; or
|
|
|
|
exposure of participants to unacceptable health risks.
|
Cornerstones ability to enroll patients in its clinical
trials in sufficient numbers and on a timely basis will be
subject to a number of factors, including the size of the
patient population, the nature of the protocol, the proximity of
patients to clinical sites, the seasonality of the disease, the
availability of effective treatments for the relevant disease,
competing trials with other product candidates and the
eligibility criteria for the clinical trial. Delays in patient
enrollment can result in increased costs and longer development
times. In addition, subjects may drop out of Cornerstones
clinical trials and thereby impair the validity or statistical
significance of the trials. Delays in patient enrollment and the
related increase in costs also could cause Cornerstone to decide
to discontinue a clinical trial prior to completion.
Cornerstone expects to rely on academic institutions and
contract research organizations to supervise or monitor some or
all aspects of the clinical trials for the product candidates it
advances into clinical testing. Accordingly, Cornerstone has
less control over the timing and other aspects of these clinical
trials than if it conducted them entirely on its own.
Although Cornerstone has not previously experienced the
foregoing risks with respect to its clinical trials, as a result
of these risks, Cornerstone or third parties on whom it relies
may not successfully begin or complete Cornerstones
clinical trials in the time periods forecasted, if at all. If
the results of Cornerstones planned clinical trials for
its product candidates are not available when it expects or if
Cornerstone encounters any delays in the analysis of data from
its clinical trials, it may be unable to submit results for
regulatory approval or clearance or conduct additional clinical
trials on the schedule it anticipates.
If clinical trials are delayed, the commercial viability of
Cornerstones product candidates may be reduced. If
Cornerstone incurs costs and delays in its programs, or if
Cornerstone does not successfully develop and commercialize its
products, its future operating and financial results will be
materially affected.
If
Cornerstones clinical trials do not demonstrate safety and
efficacy in humans, Cornerstone may experience delays, incur
additional costs and ultimately be unable to commercialize its
product candidates.
Depending upon the nature of the product candidate, obtaining
regulatory approval for the sale of its product candidates may
require Cornerstone and its collaborators to fund and conduct
clinical trials to demonstrate the
68
safety and efficacy of Cornerstones product candidates in
humans. Clinical testing is expensive, difficult to design and
implement, uncertain as to outcome and, depending on the design
of the trial, takes several years or more to complete. Clinical
data is often susceptible to varying interpretations, and many
companies that have believed their products performed
satisfactorily in clinical trials were nonetheless unable to
obtain FDA approval for their product candidates. Similarly,
even if clinical trials of a product candidate are successful in
one indication, clinical trials of that product candidate for
other indications may be unsuccessful. One or more of
Cornerstones clinical trials could fail at any stage of
testing.
Cornerstone expects to submit an NDA to the FDA in 2009 for
SPECTRACEF Suspension for use of this product candidate by
children with pharyngitis or tonsillitis. TAP Pharmaceuticals,
Inc., or TAP, conducted all of the preclinical studies and
clinical trials of the oral suspension formulation of SPECTRACEF
before Cornerstone licensed the rights to SPECTRACEF from Meiji.
Cornerstone intends to rely on the results of these prior
clinical trials to support its NDA for SPECTRACEF Suspension.
TAP conducted its clinical trials of the oral suspension
formulation of SPECTRACEF using a non-inferiority design,
meaning that the objective was to demonstrate that the safety
and effectiveness of SPECTRACEF Suspension is not inferior
relative to the control drug. However, current FDA guidelines
request superiority design clinical trials, meaning that the
objective of the clinical trials is to demonstrate that the test
drugs safety and effectiveness are superior to the control
drug. If the FDA does not permit Cornerstone to rely on the
prior clinical data for SPECTRACEF Suspension, Cornerstone would
be required to repeat some or all of the clinical trials, which
would lead to unanticipated costs and delays. Problems with the
previous trials, such as incomplete, outdated or otherwise
unacceptable data also could cause Cornerstones NDA for
this indication to be delayed or rejected.
If Cornerstone is required to conduct additional clinical trials
or other testing of its product candidates in addition to those
that it currently contemplates, if it is unable to successfully
complete its clinical trials or other testing, or if the results
of these trials or tests are not positive or are only modestly
positive or if there are safety concerns, Cornerstone may:
|
|
|
|
|
be delayed in obtaining marketing approval for its product
candidates;
|
|
|
|
not be able to obtain marketing approval;
|
|
|
|
obtain approval for indications that are not as broad as
intended; or
|
|
|
|
have the product removed from the market after obtaining
marketing approval.
|
Cornerstones product development costs also will increase
if it experiences delays in testing or obtaining approvals.
Significant clinical trial delays also could shorten the patent
protection period during which Cornerstone may have the
exclusive right to commercialize its product candidates or allow
its competitors to bring products to market before it does and
impair Cornerstones ability to commercialize its products
or product candidates.
If
Cornerstone is not able to obtain required regulatory approvals,
Cornerstone will not be able to commercialize its product
candidates, and its ability to generate revenue will be
materially impaired.
Cornerstones product candidates and the activities
associated with their development and commercialization,
including their testing, manufacture, safety, efficacy,
recordkeeping, labeling, storage, approval, advertising,
promotion, sale and distribution, are subject to comprehensive
regulation by the FDA, the DEA and other regulatory agencies in
the United States and by comparable authorities in other
countries. Failure to obtain regulatory approval for a product
candidate will prevent Cornerstone from commercializing the
product candidate. To obtain FDA approval, Cornerstone must
provide the FDA with data demonstrating to the FDAs
satisfaction that the product is safe and effective for each of
its intended uses and that the product can be consistently
manufactured to meet FDA quality standards and requirements. The
amount and type of data required will depend on the type of
approval required or available for a particular product
candidate. The most stringent requirements apply to NDA
approvals, which require extensive safety and efficacy data from
adequate and well controlled clinical trials. Products that are
essentially identical to FDA-listed and
NDA-approved
drugs may be approved under an ANDA with proof of bioequivalence
to the reference listed drug and a showing that the product
candidate is the same as an already-approved drug in
terms of active pharmaceutical ingredients, indications for use,
labeling, dosage strength, dosage form and route of
administration, in lieu of clinical trials. In addition,
products approved based on the submission of an NDA
69
under Section 505(b)(2) of the FDCA by relying, in part, on
findings of safety and efficacy of a similar previously approved
product may or may not require additional clinical testing. In
all cases, securing FDA approval also requires the submission of
information about the product manufacturing process to, and
inspection of the manufacturing facilities by, the FDA.
Cornerstones future products may not be effective, may be
only moderately effective or may prove to have undesirable or
unintended side effects, toxicities, manufacturing flaws, or
other characteristics that may preclude Cornerstone from
obtaining regulatory approval or prevent or limit commercial use.
The process of obtaining regulatory approvals is expensive,
often takes many years, if approval is obtained at all, and can
vary substantially based upon a variety of factors, including
the type, complexity and novelty of the product candidates
involved and the nature of the disease or condition to be
treated. Changes in regulatory approval policies during the
development period, changes in or the enactment of additional
statutes or regulations or medical and technical developments
during the review process may delay the approval or cause the
rejection of an application. The FDA has substantial discretion
in the approval process and may require additional clinical or
other data as a condition of reviewing or approving an
application. In addition, varying interpretations of the data
obtained from preclinical and clinical testing could delay,
limit or prevent regulatory approval of a product candidate. Any
regulatory approval Cornerstone ultimately obtains may be
limited or subject to restrictions or post-approval commitments
that render the approved product not commercially viable.
Cornerstones
limited experience in obtaining regulatory approvals could
delay, limit or prevent such approvals for its product
candidates.
Cornerstone has only limited experience in preparing and
submitting the applications necessary to gain regulatory
approvals and expects to rely on third-party contract research
organizations to assist it in this process. Cornerstone acquired
the rights to most of its currently marketed products and
product candidates through two licensing transactions, one for
ALLERX in February 2005 and the other for SPECTRACEF in October
2006. Except for SPECTRACEF 400 mg, for which the FDA approved
Cornerstones sNDA in July 2008, Cornerstone has not
received approval from the FDA for any of its products or
demonstrated its ability to obtain regulatory approval for any
drugs that it has developed or is developing. Cornerstones
limited experience in this regard could delay or limit approval
of its product candidates if it is unable to effectively manage
the applicable regulatory process with either the FDA or foreign
regulatory authorities. In addition, significant errors or
ineffective management of the regulatory process could prevent
approval of a product candidate, especially given the
substantial discretion that the FDA and foreign regulatory
authorities have in this process.
Some
of Cornerstones specialty pharmaceutical products are now
being marketed without approved NDAs or ANDAs.
Even though the FDCA requires pre-marketing approval of all new
drugs, as a matter of history and regulatory policy, the FDA has
historically refrained from taking enforcement action against
some marketed, unapproved new drugs. Specifically, some marketed
prescription and nonprescription drugs are not the subject of an
approved marketing application because they are thought to be
identical, related, or similar to historically-marketed
products, which were thought not to require pre-market review
and approval, or which were approved only on the basis of
safety, at the time they entered the marketplace. Many such
drugs, including some cough, cold and allergy drugs like the
ALLERX and RESPIVENT lines of products and some antispasmodic
drugs like the HYOMAX line of products, are marketed under FDA
enforcement policies established in connection with the
FDAs DESI program, which was established to determine the
effectiveness of drug products approved before 1962. Prior to
1962, the FDCA required proof of safety but not efficacy for new
drugs. Drugs that were not subject to applications approved
between 1938 and 1962 were not subject to DESI review. For a
period of time, the FDA permitted these drugs to remain on the
market without approval. In 1984, the FDA created a program,
known as the Prescription Drug
Wrap-Up,
also known as DESI II, to address these remaining unapproved
drugs. Most of these drugs contain active pharmaceutical
ingredients that were first marketed prior to 1938. The FDA
asserts that all drugs subject to the Prescription Drug
Wrap-Up are
on the market illegally and are subject to FDA enforcement
discretion because all prescription drugs must be the subject of
an approved drug application. There are several narrow
exceptions. For example, both the
70
original statutory language of the FDCA and the amendments
enacted in 1962 include provisions exempting specified drugs
from the new drug requirements. The 1938 clause exempts drugs
that were on the market prior to the passage of the FDCA in 1938
and that contain the same representations concerning the
conditions of use as they did prior to passage of the FDCA. The
1962 amendments exempt, in specified circumstances, drugs that
have the same composition and labeling as they had prior to the
passage of the 1962 amendments. The FDA and the courts have
interpreted these two exceptions very narrowly. The FDA has
adopted a risk-based enforcement policy concerning these
unapproved drugs. While all such drugs are considered to require
FDA approval, FDA enforcement against such products as
unapproved new drugs prioritizes products that pose potential
safety risks, lack evidence of effectiveness, prevent patients
from seeking effective therapies or are marketed fraudulently.
In addition, the FDA has indicated that approval of an NDA for
one drug within a class of drugs marketed without FDA approval
may also trigger agency enforcement of the new drug requirements
against all other drugs within that class that have not been so
approved.
As of September 15, 2008, Cornerstones only products
that are subject to approved NDAs or ANDAs are SPECTRACEF,
BALACET 325, APAP 325 and APAP 500.
Cornerstones net revenues from the sale of unapproved
products were $15.4 million, or 55% of total net revenues,
in the year ended December 31, 2007, and
$17.9 million, or 76% of total net revenues, in the six
months ended June 30, 2008. All of Cornerstones other
products are marketed in the United States without an
FDA-approved marketing application because they have been
considered by Cornerstone to be identical, related or similar to
products that have existed in the market without an NDA or ANDA.
These products are marketed subject to the FDAs regulatory
discretion and enforcement policies, and it is possible that the
FDA could disagree with Cornerstones determination that
one or more of these products is identical, related or similar
to products that have existed in the marketplace without an NDA
or ANDA. If the FDA were to disagree with Cornerstones
determination, it could ask for or require the removal of
Cornerstones unapproved products from the market. While
the FDA generally provides sponsors with a one-year grace period
during which time they are permitted to continue selling the
unapproved drug, it is not statutorily required to do so and
could ask or require that the products be removed from the
market immediately. If the FDA required Cornerstone to remove
its unapproved products from the market, particularly its ALLERX
Dose Pack family of products and its HYOMAX line of products,
Cornerstones revenue from product sales would be
significantly reduced.
For example, if the FDA issues an approved NDA for one of the
drug products within the class of drugs that includes ALLERX or
completes the efficacy review for that drug product, it may
require Cornerstone to also file an NDA or ANDA application for
its ALLERX products in order to continue marketing them in the
United States. Although Cornerstone may be given the benefit of
a grace period to submit a marketing application before the
agency would take enforcement action, the time it takes
Cornerstone to complete the necessary clinical trials and submit
an NDA or ANDA to the FDA may exceed this time period, which
would result in an interruption of sales of ALLERX. If the FDA
asks or requires that the ALLERX products be removed from the
market, Cornerstones financial condition and results of
operations would be materially and adversely affected.
Cornerstones net revenues from sales of its ALLERX
products were $14.2 million in the year ended
December 31, 2007 and $12.9 million in the six months
ended June 30, 2008. Cornerstone filed an IND with the FDA
in 2007 for a respiratory product containing methscopolamine,
one of the APIs in all ALLERX Dose Pack products. A similar
result would apply if the FDA issued an approved NDA for one of
the drug products within the class of drugs that includes the
HYOMAX products or completed the efficacy review for that drug
product and required other manufacturers to also file an NDA or
ANDA for their products in order to continue marketing them in
the United States. Cornerstones net revenues from sales of
its HYOMAX products, which it launched beginning in May 2008,
were $4.5 million in the six months ended June 30,
2008. When the FDA announced in May 2007 that it was directing
that all non-approved extended release guaifenesin products,
including Cornerstones
Deconsal®,
or DECONSAL, II product, be removed from the market within
180 days, it noted that Adams Respiratory Therapeutics,
Inc., or Adams, was the only company to date that had obtained
FDA approval for timed-release products containing guaifenesin.
Cornerstones net revenues from sales of Deconsal II
were $177,000 in 2007 and $1.2 million in 2006.
71
Cornerstones
sales depend on payment and reimbursement from third-party
payors, and a reduction in the payment rate or reimbursement
could result in decreased use or sales of its
products.
Cornerstones sales of its currently marketed products are,
and any future sales of its product candidates will be,
dependent, in part, on the availability of coverage and
reimbursement from third-party payors, including government
health care programs such as Medicare and Medicaid, and private
insurance plans. All of Cornerstones products are
generally covered by managed care and private insurance plans.
The status or tier within each plan varies but coverage is
similar to other products within the same class of drugs. For
example, SPECTRACEF is covered by private insurance plans
similar to other marketed, branded cephalosporins. Some Medicare
Part D plans also cover some or all of Cornerstones
products, but the amount and level of coverage varies from plan
to plan. Cornerstone also participates in the Medicaid Drug
Rebate program with the Centers for Medicare &
Medicaid Services and submits all of its products for inclusion
in this program. Coverage of Cornerstones products under
individual state Medicaid plans varies from state to state.
There have been, there are and Cornerstone expects there will
continue to be federal and state legislative and administrative
proposals that could limit the amount that government health
care programs will pay to reimburse the cost of pharmaceutical
and biologic products. For example, the MMA created a new
Medicare benefit for prescription drugs. More recently, the
Deficit Reduction Act of 2005 significantly reduced
reimbursement for drugs under the Medicaid program. Legislative
or administrative acts that reduce reimbursement for
Cornerstones products could adversely impact its business.
In addition, private insurers, such as MCOs, may adopt their own
reimbursement reductions in response to federal or state
legislation. Any reduction in reimbursement for
Cornerstones products could materially harm its results of
operations. In addition, Cornerstone believes that the
increasing emphasis on managed care in the United States
has and will continue to put pressure on the price and usage of
its products, which may adversely impact its product sales.
Furthermore, when a new product is approved, governmental and
private coverage for that product, and the amount for which that
product will be reimbursed, are uncertain. Cornerstone cannot
predict the availability or amount of reimbursement for its
product candidates, and current reimbursement policies for
marketed products may change at any time.
The MMA established a voluntary prescription drug benefit,
called Part D, that became effective in 2006 for all
Medicare beneficiaries. Cornerstone cannot be certain that its
currently marketed products will continue to be, or any of its
product candidates still in development will be, included in the
Medicare prescription drug benefit. Even if Cornerstones
products are included, the private health plans that administer
the Medicare drug benefit can limit the number of prescription
drugs that are covered on their formularies in each therapeutic
category and class. In addition, private managed care plans and
other government agencies continue to seek price discounts.
Because many of these same private health plans administer the
Medicare drug benefit, they have the ability to influence
prescription decisions for a larger segment of the population.
In addition, certain states have proposed or adopted various
programs under their Medicaid programs to control drug prices,
including price constraints, restrictions on access to certain
products and bulk purchasing of drugs.
If Cornerstone succeeds in bringing additional products to the
market, these products may not be considered cost-effective, and
reimbursement to the patient may not be available or sufficient
to allow it to sell its product candidates on a competitive
basis to a sufficient patient population. Because
Cornerstones product candidates are in the development
stage, it does not know whether payors will cover the products
and the level of reimbursement, if any, it will receive for
these product candidates if they are successfully developed, and
is unable at this time to determine the cost-effectiveness of
these product candidates. Cornerstone may need to conduct
expensive pharmacoeconomic trials in order to demonstrate the
cost-effectiveness of its products. Sales of prescription drugs
are highly dependent on the availability and level of
reimbursement to the consumer from third-party payors, such as
government and private insurance plans. These third-party payors
frequently require that drug companies provide them with
predetermined discounts or rebates from list prices, and
third-party payors are increasingly challenging the prices
charged for medical products. If the reimbursement Cornerstone
receives for any of its product candidates is inadequate in
light of its development and other costs, its ability to realize
profits from the affected product candidate would be limited. If
reimbursement for Cornerstones marketed products changes
adversely or if it fails to obtain adequate reimbursement for
its other current or future products, health care providers may
limit how much or under what circumstances they will prescribe
or administer them, which could reduce use of its products or
cause it to reduce the price of its products.
72
If
Cornerstone fails to comply with post-approval regulatory
requirements for its products or if it experiences unanticipated
problems with its marketed products, the FDA may take regulatory
actions detrimental to Cornerstones business, resulting in
temporary or permanent interruption of distribution, withdrawal
of products from the market or other penalties.
Cornerstones FDA-approved products and related operations
will be subject to comprehensive post-approval regulation by the
FDA. Post-approval requirements include submissions of safety
and other post-marketing information; record-keeping and
reporting; annual registration of manufacturing facilities and
listing of products with the FDA; ongoing compliance with
current Good Manufacturing Practice, or cGMP, regulations; and
requirements regarding the distribution of samples to physicians
and related recordkeeping. Additional, potentially costly,
requirements may apply to specific products as a condition of
FDA approval or subsequent regulatory developments. Discovery of
previously unknown problems with Cornerstones products,
manufacturers or manufacturing processes, or failure to comply
with regulatory requirements, may result in:
|
|
|
|
|
withdrawal of the products from the market;
|
|
|
|
restrictions on the marketing or distribution of such products;
|
|
|
|
restrictions on the manufacturers or manufacturing processes;
|
|
|
|
warning letters;
|
|
|
|
refusal to approve pending applications or supplements to
approved applications that Cornerstone submits;
|
|
|
|
recalls;
|
|
|
|
fines;
|
|
|
|
suspension or withdrawal of regulatory approvals;
|
|
|
|
refusal to permit the import or export of its products;
|
|
|
|
product seizures; or
|
|
|
|
injunctions or the imposition of civil or criminal penalties.
|
Any of these actions could have a material adverse effect on
Cornerstones business, financial condition and results of
operations.
State
pharmaceutical marketing and promotional compliance and
reporting requirements may expose Cornerstone to regulatory and
legal action by state governments or other government
authorities.
In recent years, several states, including California, Maine,
Minnesota, Nevada, New Mexico, Vermont and West Virginia, as
well as the District of Columbia, have enacted legislation
requiring pharmaceutical companies to establish marketing and
promotional compliance programs and file periodic reports with
the state on sales, marketing, pricing, reporting and other
activities. For example, a California statute effective
July 1, 2005 requires pharmaceutical companies to adopt and
post on their public web site a comprehensive compliance program
that complies with the Pharmaceutical Research and Manufacturers
of America Code on Interactions with Healthcare Professionals
and the Office of Inspector General of the Department of Health
and Human Services Compliance Program Guidance for
Pharmaceutical Manufacturers. In addition, such a compliance
program must establish a specific annual dollar limit on gifts
or other items given to individual health care professionals in
California.
Other states have also enacted statutes of varying scope that
impose reporting and disclosure requirements on pharmaceutical
companies pertaining to drug pricing and payments and costs
associated with pharmaceutical marketing, advertising and
promotional activities, as well as restrictions upon the types
of gifts that may be provided to health care practitioners.
Similar legislation is being considered in a number of other
states. Many of these requirements are new and have not been
definitively interpreted by state authorities or courts, and
available guidance is limited. Unless and until Cornerstone is
in full compliance with these laws, it could face enforcement
action and fines and other penalties, and could receive adverse
publicity, all of which could materially harm its business.
73
Recently
enacted legislation may make it more difficult and costly for
Cornerstone to obtain regulatory approval of its product
candidates and to produce, market and distribute its existing
products.
On September 27, 2007, President Bush signed the FDAAA into
law. The FDAAA grants a variety of new powers to the FDA, many
of which are aimed at improving drug safety and assuring the
safety of drug products after approval. Under the FDAAA,
companies that violate the new law are subject to substantial
civil monetary penalties. While Cornerstone expects the FDAAA to
have a substantial effect on the pharmaceutical industry, the
extent of that effect is not yet known. As the FDA issues
regulations, guidance and interpretations relating to the new
legislation, the impact on the industry, as well as its
business, will become clearer. The new requirements and other
changes that the FDAAA imposes may make it more difficult, and
likely more costly, to obtain approval of new pharmaceutical
products and to produce, market and distribute existing products.
Cornerstone
may be subject to investigations or other inquiries concerning
its compliance with reporting obligations under federal health
care program pharmaceutical pricing requirements.
There have been a number of government enforcement actions under
the federal health care programs, primarily Medicare and
Medicaid, against numerous pharmaceutical companies alleging
that the reporting of prices for pharmaceutical products has
resulted in false and overstated prices, such as average
wholesale and best price, which are alleged to have improperly
inflated the reimbursements paid by Medicare, state Medicaid
programs and other payors to health care providers who
prescribed and administered those products or pharmacies that
dispensed those products. These actions have been brought by
both the federal government and individual states. Failure to
comply with these government health care program pharmaceutical
pricing requirements may lead to federal or state
investigations, criminal or civil liability, exclusion from
government health care programs, contractual damages and
otherwise materially harm Cornerstones reputation,
business and prospects.
Cornerstones
corporate compliance and corporate governance programs cannot
guarantee that it is in compliance with all potentially
applicable regulations.
The development, manufacturing, pricing, marketing, sales and
reimbursement of Cornerstones products and product
candidates, together with Cornerstones general operations,
are subject to extensive regulation by federal, state and other
authorities within the United States. Cornerstone is a
relatively small company and had approximately 83 employees as
of September 15, 2008. Cornerstone has developed and
instituted a corporate compliance program designed to comply
with current best practices for pharmaceutical companies and
continues to update the program in response to newly implemented
and changing regulatory requirements. However,
Cornerstones compliance program does not and cannot
guarantee that the company is in compliance with all potentially
applicable federal and state regulations. If Cornerstone fails
to comply with any of these regulations, it may be subject to a
range of enforcement actions, including significant fines,
litigation or other sanctions. Any action against Cornerstone
for a violation of these regulations, even if it successfully
defends against such actions, could cause it to incur
significant legal expenses, divert its managements
attention and harm its reputation.
Cornerstones
relationships with customers and payors are subject to
applicable fraud and abuse and other health care laws and
regulations, which could expose it to criminal sanctions, civil
penalties, contractual damages, reputational harm, and
diminished profits and future earnings.
Health care providers, physicians and others play a primary role
in the recommendation and prescription of Cornerstones
products. Cornerstones arrangements with third-party
payors and customers may expose it to broadly applicable fraud
and abuse and other health care laws and regulations that may
constrain the business or financial arrangements and
relationships through which it will market, sell and distribute
its products. Applicable federal and state health care laws and
regulations, include, but are not limited to, the following:
|
|
|
|
|
The federal anti-kickback statute is a criminal statute that
makes it a felony for individuals or entities knowingly and
willfully to offer or pay or to solicit or receive, direct or
indirect remuneration, in order to induce business reimbursed
under a federal health care program, including Medicare and
Medicaid;
|
74
|
|
|
|
|
The federal Statute on Limitations of Certain Physician
Referrals, commonly referred to as the Stark Law, prohibits
physician referrals for designated health services to entities
in which the referring physician or an immediate family member
has a financial interest, either through an ownership or
investment interest or a compensation arrangement, unless the
arrangement falls within a specific exception;
|
|
|
|
The federal False Claims Act imposes liability on any person who
knowingly submits, or causes another person or entity to submit,
a false claim for payment of government funds. Penalties include
three times the governments damages plus civil penalties
of $5,500 to $11,000 per false claim. In addition, the False
Claims Act permits a person with knowledge of fraud, referred to
as a qui tam plaintiff, to file a lawsuit on behalf of
the government against the person or business that committed the
fraud. If the action is successful, the qui tam plaintiff
is rewarded with a percentage of the recovery;
|
|
|
|
HIPAA imposes obligations, including mandatory contractual
terms, with respect to safeguarding the privacy, security and
transmission of individually identifiable health information;
|
|
|
|
The Social Security Act contains numerous provisions allowing
the imposition of a civil money penalty, a monetary assessment,
exclusion from the Medicare and Medicaid programs, or some
combination of these penalties; and
|
|
|
|
Many states have analogous state laws and regulations, such as
state anti-kickback and false claims laws. In some cases, these
state laws impose more strict requirements than the federal
laws. Some state laws also require pharmaceutical companies to
comply with certain price reporting and other compliance
requirements.
|
Efforts to help ensure that Cornerstones business
arrangements comply with these extensive federal and state
health care fraud and abuse laws could be costly. It is possible
that governmental authorities may conclude that
Cornerstones business practices do not comply with current
or future statutes or regulations involving applicable fraud and
abuse or other health care laws and regulations. If
Cornerstones past or present operations, including
activities conducted by its sales team or agents, are found to
be in violation of any of these laws or any other applicable
governmental regulations, Cornerstone may be subject to
significant civil, criminal and administrative penalties,
damages, fines, exclusion from government health care programs
and the curtailment or restructuring of its operations. If any
of the physicians or other providers or entities with whom
Cornerstone does business is found not to be in compliance with
applicable laws, they may also be subject to criminal, civil or
administrative sanctions, including exclusions from government
health care programs.
Many aspects of these laws have not been definitively
interpreted by the regulatory authorities or the courts, and
their provisions are open to a variety of subjective
interpretations, which increases the risk of potential
violations. In addition, these laws and their interpretations
are subject to change. Any action against Cornerstone for
violation of these laws, even if Cornerstone successfully
defends against the action, could cause Cornerstone to incur
significant legal expenses, divert Cornerstone managements
attention from the operation of its business and damage its
reputation.
Recent
proposed legislation may permit re-importation of drugs from
foreign countries into the United States, including foreign
countries where the drugs are sold at lower prices than in the
United States, which could force Cornerstone to lower the
prices of its products and impair its ability to derive revenue
from its products.
Legislation has been introduced in the United States Congress
that, if enacted, would permit more widespread re-importation of
FDA-approved drugs from foreign countries into the United
States. This could include
re-importation
from foreign countries where the drugs are sold at lower prices
than in the United States. While Cornerstone does not currently
sell any of its products outside the United States, legislation
or other factors that increase such sales by Cornerstones
direct competitors could adversely affect Cornerstones
pricing and revenues Alternatively, in response to legislation
such as this, Cornerstone might elect not to seek approval for
or market its products in foreign jurisdictions in order to
minimize the risk of re-importation, which could also reduce the
revenue Cornerstone generates from its product sales.
75
Risks
Relating to Intellectual Property and Licenses
If
Cornerstone is unable to obtain and maintain protection for the
intellectual property relating to its technology and products,
the value of its technology and products will be adversely
affected.
Cornerstones success depends in part on its ability to
obtain and maintain protection for the intellectual property
covering or incorporated into its technology and products,
whether such technology is owned by Cornerstone or licensed to
it by third parties. Patent protection in the pharmaceutical
field is highly uncertain and involves complex legal and
scientific questions. Cornerstone and its licensors may not be
able to obtain additional issued patents relating to their
respective technology or products. Even if issued, patents
issued to Cornerstone or its licensors may be challenged,
narrowed, invalidated, held to be unenforceable or circumvented,
which could limit Cornerstones ability to stop competitors
from marketing similar products or limit the longevity of the
patent protection Cornerstone may have for its products. For
example, two U.S. patents exclusively licensed to
Cornerstone have been challenged by third parties in
re-examination proceedings before the U.S. Patent and
Trademark Office. While Cornerstone no longer relies on one of
the patents to protect any of its products, Cornerstone believes
that the other U.S. patent being re-examined,
U.S. patent 6,843,372, or the 372 Patent, covers
ALLERX 10 Dose Pack, ALLERX 30 Dose Pack, ALLERX Dose Pack PE
and ALLERX Dose Pack PE 30. If the United States Patent and
Trademark Office invalidates some or all of the claims under the
372 Patent, Cornerstones sales of the ALLERX family
of products and its future operating and financial results could
be adversely affected. These re-examination proceedings are more
fully discussed in the section entitled Cornerstones
Business Legal Proceedings beginning on
page 232 of this proxy statement/prospectus. Additionally,
changes in either patent laws or in interpretations of patent
laws in the United States and other countries may diminish the
value of Cornerstones intellectual property or narrow the
scope of its patent protection.
Cornerstones owned or licensed patents also may not afford
it protection against competitors with similar technology.
Because patent applications in the United States and many other
jurisdictions are typically not published until 18 months
after filing, or in some cases not at all, and because
publications of discoveries in the scientific literature often
lag behind actual discoveries, neither Cornerstone nor its
licensors can be certain that it or they were the first to make
the inventions claimed in Cornerstones or their issued
patents or pending patent applications, or that Cornerstone or
they were the first to file for protection of the inventions set
forth in these patent applications. If a third party has also
filed a U.S. patent application covering Cornerstones
product candidates or a similar invention, Cornerstone may have
to participate in an adversarial proceeding, known as an
interference, declared by the United States Patent and Trademark
Office to determine priority of invention in the United States.
The costs of these proceedings could be substantial, and it is
possible that Cornerstones efforts could be unsuccessful,
resulting in a loss of its U.S. patent protection. In
addition, patents generally expire, regardless of the date of
issue, 20 years from the earliest claimed non-provisional
filing date. Cornerstone is not able to accurately predict the
remaining lengths of the applicable patent term following
regulatory approval of any of its product candidates.
Some of Cornerstones currently marketed products do not
have patent protection and in most cases such products face
generic competition. In addition, although Cornerstone owns or
exclusively licenses U.S. patents and patent applications
with claims directed to the pharmaceutical formulations of its
product candidates, methods of use of its product candidates to
treat particular conditions, delivery systems for its product
candidates, delivery profiles of its product candidates and
methods for producing its product candidates, patent protection
is not available for composition of matter claims directed to
the active pharmaceutical ingredients of any of
Cornerstones products or product candidates other than
SPECTRACEF and the SPECTRACEF line extensions. The SPECTRACEF
composition of matter patent expires in April 2009.
Cornerstones collaborators and licensors may not
adequately protect its intellectual property rights. These third
parties may have the first right to maintain or defend
Cornerstones intellectual property rights and, although
Cornerstone may have the right to assume the maintenance and
defense of its intellectual property rights if these third
parties do not, Cornerstones ability to maintain and
defend its intellectual property rights may be compromised by
the acts or omissions of these third parties. For example, under
Cornerstones license arrangement with Pharmaceutical
Innovations, LLC, or Pharmaceutical Innovations, for ALLERX Dose
Pack and ALLERX Dose Pack PE, Pharmaceutical Innovations
generally is responsible for prosecuting and
76
maintaining patent rights, although Cornerstone has the right to
support the continued prosecution or maintenance of the patent
rights if Pharmaceutical Innovations fails to do so. In
addition, both Pharmaceutical Innovations and Cornerstone have
the right to pursue claims against third parties for
infringement of the patent rights.
The
composition of matter patent for the API in SPECTRACEF and in
Cornerstones SPECTRACEF line extension product candidates
will expire in April 2009, and none of Cornerstones other
products or product candidates have, or will have, composition
of matter patent protection.
Cornerstones products other than SPECTRACEF and product
candidates other than the SPECTRACEF line extensions lack
composition of matter protection for the API, and because the
composition of matter patent for SPECTRACEF expires in April
2009, competitors will be able to offer and sell products with
the same API as Cornerstones products so long as these
competitors do not infringe any other patents that Cornerstone
or third parties hold, including formulation and method of use
patents. However, method of use patents, in particular, are more
difficult to enforce than composition of matter patents because
of the risk of off-label sale or use of the subject compounds.
Physicians are permitted to prescribe an approved product for
uses that are not described in the products labeling.
Although off-label prescriptions may infringe Cornerstones
method of use patents, the practice is common across medical
specialties and such infringement is difficult to prevent or
prosecute. Off-label sales would limit Cornerstones
ability to generate revenue from the sale of its product
candidates, if approved for commercial sale. In addition, if a
third party were able to design around Cornerstones
formulation and process patents and create a different
formulation using a different production process not covered by
Cornerstones patents or patent applications, Cornerstone
would likely be unable to prevent that third party from
manufacturing and marketing its product.
Trademark
protection of Cornerstones products may not provide it
with a meaningful competitive advantage.
Cornerstone uses trademarks on most of its currently marketed
products and believes that having distinctive marks is an
important factor in marketing those products, particularly
SPECTRACEF and ALLERX. Distinctive marks may also be important
for any additional products that Cornerstone successfully
develops and commercially markets. However, Cornerstone
generally does not expect its marks to provide a meaningful
competitive advantage over other branded or generic products.
Cornerstone believes that efficacy, safety, convenience, price,
the level of generic competition and the availability of
reimbursement from government and other third-party payors are
and are likely to continue to be more important factors in the
commercial success of its products and, if approved, its product
candidates. For example, physicians and patients may not readily
associate Cornerstones trademark with the applicable
product or API. In addition, prescriptions written for a branded
product are typically filled with the generic version at the
pharmacy if an approved generic is available, resulting in a
significant loss in sales of the branded product, including for
indications for which the generic version has not been approved
for marketing by the FDA. Competitors also may use marks or
names that are similar to Cornerstones trademarks. If
Cornerstone initiates legal proceedings to seek to protect its
trademarks, the costs of these proceedings could be substantial
and it is possible that its efforts could be unsuccessful.
Competitors may also seek to cancel Cornerstones similar
trademarks based on the competitors prior use. For
example, on May 15, 2008, the United States Patent and
Trademark Office sent written notice to Cornerstone that
Bausch & Lomb Incorporated, or Bausch &
Lomb, filed a cancellation proceeding with respect to the ALLERX
registration, 3,384,232 (serial number 77120121), seeking to
cancel the ALLERX registration because of a claim that such
registration dilutes the distinctive quality of
Bausch & Lombs
Alrex®
trademark and that Bausch & Lomb is likely to be
damaged by the ALLERX registration. Cornerstone responded to the
Trademark Trial and Appeal Board on June 24, 2008 opposing
the claims by Bausch & Lomb, but is concurrently
engaging in discussions with Bausch & Lomb to seek
settlement of the cancellation proceeding on favorable terms. If
the settlement discussions do not provide a prior resolution,
Cornerstone could take numerous courses of action, including
continuing to oppose the claims, undertaking action to cancel
Bausch & Lombs registration of its
Alrex®
trademark, or entering into discovery. If the United States
Patent and Trademark Office cancels the ALLERX registration,
Cornerstone will be required to cease marketing its
77
products under that brand, which could adversely affect
Cornerstones sales of the ALLERX family of products and
its future operating and financial results.
If
Cornerstone fails to comply with its obligations in its
intellectual property licenses with third parties, it could lose
license rights that are important to its business.
Cornerstone has acquired intellectual property rights relating
to all of its product candidates under license agreements with
third parties and expects to enter into additional licenses in
the future. These licenses provide Cornerstone with rights to
intellectual property that is necessary for its business. For
example, Cornerstone acquired from Meiji the exclusive
U.S. rights to market, develop and commercialize
SPECTRACEF. Pursuant to its agreement with Meiji, Cornerstone
obtained an exclusive license to use know-how and trademarks to
commercialize SPECTRACEF and any other pharmaceutical product,
such as SPECTRACEF Suspension, containing the API cefditoren
pivoxil in the United States.
Cornerstones existing licenses impose, and Cornerstone
expects that future licenses will impose, various obligations
related to development and commercialization activities,
milestone and royalty payments, sublicensing, patent protection
and maintenance, insurance and other similar obligations common
in these types of agreements. For example, Cornerstone has
entered into an agreement with Neos Therapeutics, L.P., or Neos,
and Coating Place, Inc., or Coating Place, directed to
commercialization of certain antihistamine and antitussive
combination products, which obligates Cornerstone to use
commercially reasonable efforts to carry out development and
regulatory activities within timelines specified in such
development agreement. Under this agreement, Cornerstone is
obligated to use commercially reasonable efforts to develop and
commercially launch products containing an antihistamine and
antitussive in the United States as soon as practicable, and
thereafter to maximize sales of such licensed product in the
United States. If Cornerstone fails to comply with these
obligations or otherwise breaches the license agreement, Neos or
Coating Place may have the right to terminate the license in
whole, terminate the exclusive nature of the license or bring a
claim against Cornerstone for damages. Any such termination or
claim could prevent or impede Cornerstones ability to
market any product that is covered by the licensed patents. Even
if Cornerstone contests any such termination or claim and is
ultimately successful, Cornerstone could suffer adverse
consequences to its operations and business interests.
If
Cornerstone is unable to protect the confidentiality of its
proprietary information and know-how, the value of its
technology and products could be adversely
affected.
In addition to patented technology, Cornerstone relies upon
unpatented proprietary technology, processes and know-how.
Cornerstone seeks to protect its unpatented proprietary
information in part by confidentiality agreements with its
employees, consultants and third parties. These agreements may
be breached and Cornerstone may not have adequate remedies for
any such breach. In addition, Cornerstones trade secrets
may otherwise become known or may be independently developed by
competitors. If Cornerstone is unable to protect the
confidentiality of its proprietary information and know-how,
competitors may be able to use this information to develop
products that compete with Cornerstones products, which
could adversely impact Cornerstones business.
If
Cornerstone infringes or is alleged to infringe intellectual
property rights of third parties, Cornerstones business
will be adversely affected.
Cornerstones development and commercialization activities,
as well as any product candidates or products resulting from
these activities, may infringe or be claimed to infringe one or
more claims of an issued patent or may fall within the scope of
one or more claims in a published patent application that may
subsequently issue and to which Cornerstone does not hold a
license or other rights. Third parties may own or control these
patents or patent applications in the United States and abroad.
These third parties could bring claims against Cornerstone or
its collaborators that would cause it to incur substantial
expenses and, if such claims are successful, could cause
Cornerstone to pay substantial damages. Further, if a patent
infringement suit were brought against Cornerstone or its
collaborators, it or they could be forced to stop or delay
development, manufacturing or sales of the product or product
candidate that is the subject of the suit.
As a result of patent infringement or other similar claims or to
avoid potential claims, Cornerstone or its potential future
collaborators may choose or be required to seek a license from a
third party and be required to
78
pay license fees or royalties or both. These licenses may not be
available on acceptable terms, or at all. Even if Cornerstone or
its collaborators were able to obtain a license, the rights may
be nonexclusive, which could result in Cornerstones
competitors gaining access to the same intellectual property.
Ultimately, Cornerstone could be prevented from commercializing
a product, or be forced to cease some aspect of its business
operations, if, as a result of actual or threatened patent
infringement claims, it or its collaborators are unable to enter
into licenses on acceptable terms. This could harm
Cornerstones business significantly.
There have been substantial litigation and other proceedings
regarding patent and other intellectual property rights in the
pharmaceutical and biotechnology industries. In addition to
infringement claims against Cornerstone, Cornerstone may become
a party to other patent litigation and other proceedings,
including interference proceedings declared by the United States
Patent and Trademark Office, regarding intellectual property
rights with respect to its products and technology. The cost to
Cornerstone of any patent litigation or other proceeding, even
if resolved in its favor, could be substantial. Some of
Cornerstones competitors may be able to sustain the costs
of such litigation or proceedings more effectively than it can
because of their substantially greater financial resources.
Uncertainties resulting from the initiation and continuation of
patent litigation or other proceedings could have a material
adverse effect on Cornerstones ability to compete in the
marketplace. Patent litigation and other proceedings may also
absorb significant management time.
Many of Cornerstones employees were previously employed at
other pharmaceutical or biotechnology companies, including its
competitors or potential competitors. Cornerstone tries to
ensure that its employees do not use the proprietary information
or know-how of others in their work for Cornerstone. However,
Cornerstone may be subject to claims that it or its employees
have inadvertently or otherwise used or disclosed the
intellectual property, trade secrets or other proprietary
information of any such employees former employer.
Cornerstone may be required to engage in litigation to defend
against these claims. Even if Cornerstone is successful in such
litigation, the litigation could result in substantial costs to
Cornerstone or be distracting to its management. If Cornerstone
fails to defend or is unsuccessful in defending against any such
claims, in addition to paying monetary damages, it may lose
valuable intellectual property rights or personnel.
Risks
Relating to Cornerstones Dependence on Third
Parties
Cornerstone
uses third parties to manufacture all of its products and
product candidates. This may increase the risk that it will not
have sufficient quantities of its products or product candidates
at an acceptable cost, which could result in clinical
development and commercialization of its product candidates
being delayed, prevented or impaired.
Cornerstone has no manufacturing facilities and relies on third
parties to manufacture and supply all of its products.
Cornerstone currently relies on these third parties for the
purchase of raw materials and the manufacture and packaging of
its products. Many of the agreements Cornerstone has entered
into are exclusive agreements in which the manufacturer is a
single-source supplier, preventing Cornerstone from using
alternative sources. Cornerstone obtains all of its BALACET 325
and APAP 325 supply from Vintage, which has the exclusive right
to supply all of Cornerstones requirements for BALACET
325. Meiji has the exclusive right to supply all of
Cornerstones requirements for cefditoren pivoxil, the API
in SPECTRACEF. In addition, Cornerstones manufacturing
agreement with Bayer obligates it to purchase minimum quantities
of ALLERX bulk tablets. However, Bayer is not a
single-source supplier, and Cornerstone has another supplier
that is qualified to manufacture ALLERX. Cornerstone has also
qualified two packagers of the ALLERX product line.
If any of the third-party manufacturers with whom Cornerstone
contracts fail to perform their obligations, Cornerstone may be
adversely affected in a number of ways, including the following:
|
|
|
|
|
Cornerstone may not be able to meet commercial demands for
ALLERX, BALACET 325, or SPECTRACEF;
|
|
|
|
Cornerstone may be required to cease distribution or issue
recalls;
|
|
|
|
Cornerstone may not be able to initiate or continue clinical
trials of its product candidates that are under
development; and
|
79
|
|
|
|
|
Cornerstone may be delayed in submitting applications for
regulatory approvals for its product candidates.
|
Cornerstone may not be able to enter into alternative supply
arrangements at commercially acceptable rates, if at all. If
Cornerstone were required to change manufacturers for ALLERX,
BALACET 325, or SPECTRACEF, it would be required to verify that
the new manufacturer maintains facilities and procedures that
comply with quality standards and all applicable regulations and
guidelines, including FDA requirements and approved NDA product
specifications. In addition, Cornerstone would be required to
conduct additional clinical bioequivalence trials to demonstrate
that the products manufactured by the new manufacturer are
equivalent to the products manufactured by its current
manufacturer, which could take 12 to 18 months or possibly
longer. The technical transfer of manufacturing capabilities can
be difficult. For example, in the second quarter of 2007,
Cornerstone initiated the qualification process for two new
manufacturing sites for the five different tablet formulations
that are used in the various AM/PM dosing combinations in the
different ALLERX Dose Pack products in order to have additional
manufacturing capacity and to mitigate the risks associated with
relying on a single supplier. Both facilities initially
encountered difficulties in developing stable tablet
formulations, which were later resolved. Any delays associated
with the verification of a new manufacturer or conducting
additional clinical bioequivalence trials could adversely affect
Cornerstones production schedule or increase its
production costs and could ultimately lead to a shortage of
supply in the market.
Additionally, FDA regulations restrict the manufacture of
penicillin products in the same facility that manufactures a
cephalosporin such as SPECTRACEF. These restrictions reduce the
number of cGMP
FDA-approved
facilities that are able to manufacture cephalosporins, which
could complicate Cornerstones ability to quickly qualify a
new manufacturer for SPECTRACEF. Cornerstone is aware that
Patheon, the owner of the Puerto Rico-based manufacturing plant
for SPECTRACEF, is reviewing its strategic alternatives with
respect to this plant. Cornerstones contract for the
manufacture of SPECTRACEF is terminable by either party at any
time. There is no assurance that a buyer will be interested in
continuing the manufacture of SPECTRACEF, which could interrupt
the commercial supply and research formulation development of
SPECTRACEF and SPECTRACEF line extensions.
Cornerstone relies on third-party manufacturers to purchase the
necessary raw materials to manufacture its products, with the
exception of cefditoren pivoxil, the API in SPECTRACEF, which
Cornerstone is required to purchase from Meiji. In some
instances, Cornerstones third-party manufacturers have
encountered difficulties obtaining raw materials needed to
manufacture Cornerstones products as a result of DEA
regulations and because of the limited number of suppliers of
pseudoephedrine and methscopolamine nitrate. Although these
difficulties have not had a material adverse impact on
Cornerstone, such problems could have a material adverse impact
on Cornerstone in the future. In addition, supply interruptions
or delays could occur that require Cornerstone or its
manufacturers to obtain substitute materials or products, which
would require additional regulatory approvals. Changes in
Cornerstones raw material suppliers could result in delays
in production, higher raw material costs and loss of sales and
customers because regulatory authorities must generally approve
raw material sources for pharmaceutical products. Any
significant supply interruption could have a material adverse
effect on Cornerstones business, financial condition and
results of operation.
In addition, Cornerstone imports the API for its products from
third parties that manufacture the API outside the United
States, and Cornerstone expects to import finished product from
outside the United States in the future. This may give rise to
difficulties in obtaining API or finished product in a timely
manner as a result of, among other things, regulatory agency
import inspections, incomplete or inaccurate import
documentation or defective packaging. For example, the FDA has
stated that it will inspect 100% of API and finished product
that is imported into the United States. If the FDA requires
additional documentation from third-party manufacturers relating
to the safety or intended use of the API or finished product,
the importation of the API or finished product could be delayed.
A delay in the importation of API could, if not remediated,
cause a delay in the production of finished product. Any delays
in the production or importation of finished product could
result in a supply disruption.
80
Cornerstone
relies on its third-party manufacturers for compliance with
applicable regulatory requirements. This may increase the risk
of sanctions being imposed on Cornerstone or on a manufacturer
of its products or product candidates, which could result in
Cornerstones inability to obtain sufficient quantities of
these products or product candidates.
Cornerstones manufacturers may not be able to comply with
cGMP regulations or other regulatory requirements or similar
regulatory requirements outside the United States. DEA
regulations also govern facilities where controlled substances
are manufactured. Cornerstones manufacturers are subject
to DEA registration requirements and unannounced inspections by
the FDA, the DEA, state regulators and similar regulators
outside the United States. Cornerstones failure, or the
failure of its third-party manufacturers, to comply with
applicable regulations could result in sanctions being imposed
on Cornerstone, including:
|
|
|
|
|
fines;
|
|
|
|
injunctions;
|
|
|
|
civil penalties;
|
|
|
|
the failure of regulatory authorities to grant marketing
approval of Cornerstones product candidates;
|
|
|
|
delays, suspension or withdrawal of approvals;
|
|
|
|
suspension of manufacturing operations;
|
|
|
|
license revocation;
|
|
|
|
seizures or recalls of products or product candidates;
|
|
|
|
operating restrictions; and
|
|
|
|
criminal prosecutions.
|
Any of these sanctions could significantly and adversely affect
supplies of Cornerstones products and product candidates.
Cornerstone
relies on third parties to conduct its clinical trials, and
those third parties may not perform satisfactorily, including
failing to meet established deadlines for the completion of such
trials.
Cornerstone does not independently conduct clinical trials for
its product candidates. Cornerstone relies on third parties,
such as contract research organizations, clinical data
management organizations, medical institutions and clinical
investigators, to perform this function. Its reliance on these
third parties for clinical development activities reduces its
control over these activities. Cornerstone is responsible for
ensuring that each of its clinical trials is conducted in
accordance with the general investigational plan and protocols
for the trial. Moreover, the FDA requires Cornerstone to comply
with standards, commonly referred to as Good Clinical Practices,
for conducting, recording, and reporting the results of clinical
trials to assure that data and reported results are credible and
accurate and that the rights, integrity and confidentiality of
trial participants are protected. Cornerstones reliance on
third parties that it does not control does not relieve it of
these responsibilities and requirements. Furthermore, these
third parties may also have relationships with other entities,
some of which may be Cornerstones competitors. If these
third parties do not successfully carry out their contractual
duties, meet expected deadlines or conduct Cornerstones
clinical trials in accordance with regulatory requirements or
its stated protocols, Cornerstone will not be able to obtain, or
may be delayed in obtaining, regulatory approvals for its
product candidates and will not be able to, or may be delayed in
its efforts to, successfully commercialize its product
candidates.
Cornerstone
relies on third parties to market and promote some products, and
these third parties may not successfully commercialize these
products.
Cornerstone may seek to enter into co-promotion arrangements to
enhance its promotional efforts and, therefore, sales of its
products. By entering into agreements with pharmaceutical
companies that have experienced sales forces with strong
management support, Cornerstone can reach health care providers
in areas where it has limited or no sales force representation,
thus expanding the reach of its sales and marketing programs for
its promoted products. Cornerstone also seeks to enter into
co-promotion
arrangements for the marketing of products that are not aligned
with its respiratory focus and, therefore, are not promoted by
81
Cornerstones sales force. For example, in July 2007, Atley
Pharmaceuticals began marketing and promoting BALACET 325 to
pain specialists and other high prescribers of pain products
through a
co-promotion
agreement. Cornerstone may not be successful in entering into
additional marketing arrangements in the future and, even if
successful, it may not be able to enter into these arrangements
on terms that are favorable to Cornerstone. In addition,
Cornerstone may have limited or no control over the sales,
marketing and distribution activities of these third parties. If
these third parties are not successful in commercializing the
products covered by these arrangements, Cornerstones
future revenues may suffer.
Any
collaboration arrangements that Cornerstone may enter into in
the future may not be successful, which could adversely affect
its ability to develop and commercialize its product
candidates.
Cornerstone has entered into and may in the future enter into
collaboration arrangements on a selective basis. Any future
collaborations that it enters into may not be successful. The
success of its collaboration arrangements will depend heavily on
the efforts and activities of its collaborators. Collaborators
generally have significant discretion in determining the efforts
and resources that they will apply to these collaborations.
Disagreements between parties to a collaboration arrangement
regarding clinical development and commercialization matters can
lead to delays in the development process or the
commercialization of the applicable product candidate and, in
some cases, termination of the collaboration arrangement. These
disagreements can be difficult to resolve if neither of the
parties has final decision-making authority.
Collaborations with pharmaceutical companies and other third
parties often are terminated or allowed to expire by the other
party. Any such termination or expiration of its collaboration
agreements would adversely affect Cornerstone financially and
could harm its business reputation.
The
concentration of its product sales to only a few wholesale
distributors increases the risk that Cornerstone will not be
able to effectively distribute its products if it needs to
replace any of these customers, which would cause
Cornerstones sales to decline.
The majority of Cornerstones sales are to a small number
of pharmaceutical wholesale distributors, which in turn sell
Cornerstones products primarily to retail pharmacies,
which ultimately dispense its products to the end consumers. In
2007, Cardinal Health, McKesson and AmerisourceBergen accounted
for 91% of Cornerstones total sales.
If any of these customers cease doing business with Cornerstone
or materially reduce the amount of product they purchase from it
and Cornerstone is unable to enter into agreements with
replacement wholesale distributors on commercially reasonable
terms, it might not be able to effectively distribute its
products through retail pharmacies. The risk of this occurring
is exacerbated by the recent significant consolidation in the
wholesale drug distribution industry, including through mergers
and acquisitions among wholesale distributors and the growth of
large retail drugstore chains. As a result, a small number of
large wholesale distributors control a significant share of the
market.
Cornerstones
business could suffer as a result of a failure to manage and
maintain its distribution network.
Cornerstone relies on third parties to distribute its products.
Cornerstone has contracted with DDN/Obergfel, LLC, or DDN, for
the distribution of its products to wholesalers, retail drug
stores, mass merchandisers and grocery stores in the United
States.
This distribution network requires significant coordination with
Cornerstones supply chain, sales and marketing and finance
organizations. Failure to maintain Cornerstones contract
with DDN, or the inability or failure of DDN to adequately
perform as agreed under its contract with Cornerstone, could
negatively impact Cornerstone. Cornerstone does not have its own
warehouse or distribution capabilities, it lacks the resources
and experience to establish any of these functions and it does
not intend to establish these functions in the foreseeable
future. If Cornerstone were unable to replace DDN in a timely
manner in the event of a natural disaster, failure to meet FDA
and other regulatory requirements, business failure, strike or
any other difficulty affecting DDN, the distribution of its
products could be delayed or interrupted, which would damage
Cornerstones results of operations and market position.
Failure to coordinate financial systems could also negatively
impact Cornerstones ability to accurately report and
forecast product sales and fulfill its regulatory
82
obligations. If Cornerstone is unable to effectively manage and
maintain its distribution network, sales of its products could
be severely compromised and its business could be harmed.
Cornerstone also depends on the distribution abilities of its
wholesale customers to ensure that Cornerstones products
are effectively distributed through the supply chain. If there
are any interruptions in Cornerstones customers
ability to distribute products through their distribution
centers, Cornerstones products may not be effectively
distributed, which could cause confusion and frustration among
pharmacists and lead to product substitution. For example, in
the fourth quarter of 2007 and the first quarter of 2008,
several Cardinal Health distribution centers were placed on
probation by the DEA and were prohibited from distributing
controlled substances. Although Cardinal Health had a plan in
place to re-route all orders to the next closest distribution
center for fulfillment, system inefficiency resulted in a
failure to effectively distribute Cornerstones products to
all areas.
Risks
Relating to Cornerstones Financial Results
Cornerstone
may need additional funding and may be unable to raise capital
when needed, which could force it to delay, reduce or eliminate
its product development or commercialization
efforts.
Cornerstone has incurred and expects to continue to incur
significant development expenses in connection with its ongoing
activities, particularly as it conducts clinical trials for its
product candidates. In addition, Cornerstone incurs significant
commercialization expenses related to its currently marketed
products for sales, marketing, manufacturing and distribution.
Cornerstone incurred total commercialization expenses of
$11.9 million, representing approximately 69% of its total
operating expenses, in 2007, and $7.1 million, representing
approximately 50% of its total operating expenses, in 2006.
Cornerstone expects these commercialization expenses to increase
in future periods if Cornerstone is successful in obtaining FDA
approval to market the SPECTRACEF line extensions and its other
product candidates. Cornerstone has used, and expects to
continue to use, revenue from sales of its marketed products to
fund a significant portion of the development costs of its
product candidates and to expand its sales and marketing
infrastructure. However, Cornerstone may need substantial
additional funding for these purposes and may be unable to raise
capital when needed or on acceptable terms, which would force it
to delay, reduce or eliminate its development programs or
commercialization efforts.
As of June 30, 2008, Cornerstone had approximately $19,000
of cash and cash equivalents on hand and available borrowing
capacity of $3.9 million under its $4.0 million
revolving line of credit. Based on its current operating plans,
Cornerstone believes that its existing cash and cash
equivalents, revenue from product sales and borrowing
availability under its revolving line of credit are sufficient
to continue to fund its existing level of operating expenses and
capital expenditure requirements as a standalone company for the
foreseeable future.
Cornerstones future capital requirements will depend on
many factors, including:
|
|
|
|
|
the level of product sales from its currently marketed products
and any additional products that Cornerstone may market in the
future;
|
|
|
|
the scope, progress, results and costs of development activities
for Cornerstones current product candidates;
|
|
|
|
the costs, timing and outcome of regulatory review of
Cornerstones product candidates;
|
|
|
|
the number of, and development requirements for, additional
product candidates that Cornerstone pursues;
|
|
|
|
the costs of commercialization activities, including product
marketing, sales and distribution;
|
|
|
|
the costs and timing of establishing manufacturing and supply
arrangements for clinical and commercial supplies of
Cornerstones product candidates and products;
|
|
|
|
the extent to which Cornerstone acquires or invests in products,
businesses and technologies;
|
|
|
|
the extent to which Cornerstone chooses to establish
collaboration, co-promotion, distribution or other similar
arrangements for its marketed products and product candidates;
and
|
83
|
|
|
|
|
the costs of preparing, filing and prosecuting patent
applications and maintaining, enforcing and defending claims
related to intellectual property owned by or licensed to
Cornerstone.
|
The
terms of any additional capital funding that Cornerstone
requires may not be favorable to Cornerstone or its
stockholders.
To the extent that Cornerstones capital resources are
insufficient to meet its future capital requirements,
Cornerstone will need to finance its cash needs through public
or private equity offerings, debt financings, corporate
collaboration and licensing arrangements or other financing
alternatives. Additional equity or debt financing, or corporate
collaboration and licensing arrangements, may not be available
on acceptable terms, if at all. Cornerstones only
committed external source of funds is borrowing availability
under its revolving line of credit, which is personally
guaranteed by Cornerstones President and Chief Executive
Officer. Cornerstones ability to borrow under its
revolving line of credit is subject to its satisfaction of
specified conditions.
If Cornerstone raises additional funds by issuing equity
securities, Cornerstones stockholders will experience
dilution. Debt financing, if available, may involve agreements
that include covenants limiting or restricting
Cornerstones ability to take specific actions, such as
incurring additional debt, making capital expenditures or
declaring dividends. Any agreements governing debt or equity
financing may also contain terms, such as liquidation and other
preferences, that are not favorable to Cornerstone or its
stockholders. If Cornerstone raises additional funds through
collaboration and licensing arrangements with third parties,
Cornerstone may be required to relinquish valuable rights to its
future revenue streams or product candidates or to grant
licenses on terms that may not be favorable to Cornerstone.
Cornerstone
has incurred significant losses since its inception. Cornerstone
may incur losses in the future and may be unable to maintain
profitability.
From inception in 2004 through 2006, Cornerstone incurred
operating losses, including net losses of $305,000 in 2006 and
$11.4 million in 2005. Cornerstones net income was
$2.8 million in the six months ended June 30, 2008 and
$570,000 in the year ended December 31, 2007. As of
June 30, 2008, Cornerstones accumulated deficit was
$10.3 million. To date, Cornerstone has financed its
operations primarily with revenue from product sales and
borrowings under the Carolina Note and revolving credit
facilities. Cornerstone has devoted substantially all of its
efforts to:
|
|
|
|
|
establishing a sales and marketing infrastructure;
|
|
|
|
acquiring marketed products, product candidates and related
technologies;
|
|
|
|
commercializing its marketed products; and
|
|
|
|
developing its product candidates, including conducting clinical
trials.
|
Cornerstone expects to continue to incur significant development
and commercialization expenses as it:
|
|
|
|
|
seeks FDA approval for the SPECTRACEF line extensions;
|
|
|
|
advances the development of its other product candidates,
including its methscopolamine and antihistamine combination and
hydrocodone cough suppressant product candidates;
|
|
|
|
seeks regulatory approvals for its product candidates that
successfully complete clinical testing; and
|
|
|
|
expands its sales force and marketing capabilities to prepare
for the commercial launch of future products, subject to FDA
approval.
|
Cornerstone also expects to incur additional expenses to add
operational, financial and management information systems and
personnel, including personnel to support its product
development efforts.
For Cornerstone to sustain and increase its profitability, it
believes that it must succeed in commercializing additional
drugs with significant market potential. This will require
Cornerstone to be successful in a range of challenging
activities, including:
|
|
|
|
|
successfully completing clinical trials of its product
candidates;
|
84
|
|
|
|
|
obtaining and maintaining regulatory approval for these product
candidates; and
|
|
|
|
|
|
manufacturing, marketing and selling those products for which
Cornerstone may obtain regulatory approval.
|
Cornerstone may never succeed in these activities and may never
generate revenue that is sufficient to sustain or increase
profitability on a quarterly or annual basis. Cornerstones
failure to sustain and increase its profitability could impair
its ability to raise capital, expand its business, diversify its
product offerings or continue its operations.
If the
estimates Cornerstone makes, or the assumptions on which it
relies, in preparing its financial statements prove inaccurate,
its actual results may vary from those reflected in its
projections.
Cornerstones financial statements have been prepared in
accordance with accounting principles generally accepted in the
United States. The preparation of its financial statements
requires Cornerstone to make estimates and judgments that affect
the reported amounts of its assets, liabilities,
stockholders deficit, revenues and expenses, the amounts
of charges accrued by it and related disclosure of contingent
assets and liabilities. Cornerstone bases its estimates on
historical experience and on various other assumptions that it
believes to be reasonable under the circumstances. For example,
at the same time Cornerstone recognizes revenues for product
sales, it also records an adjustment, or decrease, to revenue
for estimated chargebacks, rebates, discounts, vouchers and
returns, which management determines on a
product-by-product
basis as its best estimate at the time of sale based on each
products historical experience adjusted to reflect known
changes in the factors that impact such reserves. Actual sales
allowances may exceed Cornerstones estimates for a variety
of reasons, including unanticipated competition, regulatory
actions or changes in one or more of Cornerstones
contractual relationships. Cornerstone cannot assure you,
therefore, that any of its estimates, or the assumptions
underlying them, will be correct.
Cornerstones
short operating history may make it difficult for you to
evaluate the success of its business to date and to assess
Cornerstones future viability.
Cornerstone has a short operating history. Cornerstone commenced
active operations in 2004. Cornerstone acquired most of its
currently marketed products and product candidates through two
licensing transactions, one for ALLERX in February 2005 and the
other for SPECTRACEF in October 2006, after these products were
already being marketed by other companies. Except for SPECTRACEF
400 mg, for which the FDA approved Cornerstones sNDA
in July 2008, Cornerstone has not received approval from the FDA
for any of its products or demonstrated its ability to obtain
regulatory approval for any drugs that it has developed or is
developing. In addition, Cornerstone has not demonstrated its
ability to initiate sales and marketing activities for
successful commercialization of a newly approved product. As a
relatively new business, Cornerstone may encounter unforeseen
expenses, difficulties, complications, delays and other known
and unknown factors.
Cornerstones
operating results are likely to fluctuate from period to
period.
Cornerstone anticipates that there may be fluctuations in its
future operating results. Potential causes of future
fluctuations in Cornerstones operating results may include:
|
|
|
|
|
new product launches, which could increase revenues but also
increase sales and marketing expenses;
|
|
|
|
acquisition activity;
|
|
|
|
one-time charges, such as for inventory expiration or product
quality issues;
|
|
|
|
increases in research and development expenses resulting from
the acquisition of a product candidate that requires significant
additional development;
|
|
|
|
changes in the competitive, regulatory or reimbursement
environment, which could decrease revenues or increase sales and
marketing, product development or compliance costs;
|
|
|
|
unexpected product liability or intellectual property claims and
lawsuits;
|
|
|
|
significant payments, such as milestones, required under
collaboration, licensing and development agreements before the
related product candidate has received FDA approval;
|
|
|
|
marketing exclusivity, if any, which may be obtained on certain
new products;
|
85
|
|
|
|
|
the dependence on a small number of products for a significant
portion of net revenues and net income; and
|
|
|
|
price erosion and customer consolidation.
|
Risks
Relating to Employee Matters and Managing Growth
If
Cornerstone fails to attract and retain key personnel, or to
retain its executive management team, it may be unable to
successfully develop or commercialize its
products.
Recruiting and retaining highly qualified scientific, technical
and managerial personnel and research partners will be critical
to Cornerstones success. Any expansion into areas and
activities requiring additional expertise, such as clinical
trials, governmental approvals, contract manufacturing and sales
and marketing, will place additional requirements on
Cornerstones management, operational and financial
resources. These demands may require Cornerstone to hire
additional personnel and will require its existing management
personnel to develop additional expertise. Cornerstone faces
intense competition for personnel. The failure to attract and
retain personnel or to develop such expertise could delay or
halt the development, regulatory approval and commercialization
of its product candidates. If Cornerstone experiences
difficulties in hiring and retaining personnel in key positions,
it could suffer from delays in product development, loss of
customers and sales and diversion of management resources, which
could adversely affect operating results. Cornerstone also
experiences competition for the hiring of scientific personnel
from universities and research institutions. In addition,
Cornerstone relies on consultants and advisors, including
scientific and clinical advisors, to assist it in formulating
its development and commercialization strategy.
Cornerstones consultants and advisors may be employed by
third parties and may have commitments under consulting or
advisory contracts with third parties that may limit their
availability to Cornerstone.
Cornerstone depends to a great extent on the principal members
of its management and scientific staff. The loss of the services
of any of its key personnel, in particular, Craig Collard,
President and Chief Executive Officer, and Brian
Dickson, M.D., Chief Medical Officer, might significantly
delay or prevent the achievement of Cornerstones
development and commercialization objectives and could cause
Cornerstone to incur additional costs to recruit replacements.
Each member of Cornerstones executive management team may
terminate his or her employment at any time. Cornerstone does
not maintain key person life insurance with respect
to any of its executives. Furthermore, if Cornerstone decides to
recruit new executive personnel, Cornerstone will incur
additional costs.
Risks
Related to the Combined Company
In determining whether you should approve the issuance of shares
of Critical Therapeutics common stock pursuant to the merger,
you should carefully read the following risk factors. Critical
Therapeutics and Cornerstone anticipate that, immediately
following the merger, the business of the combined company will
be the respective businesses conducted by Critical Therapeutics
and Cornerstone immediately prior to the merger. As a result,
the risk factors section of this proxy statement/prospectus
entitled Risk Factors Relating to Critical
Therapeutics and Risk Factors Relating to
Cornerstone together with the following risk factors, are
the most significant you will face if the merger is completed.
The
integration of Critical Therapeutics and Cornerstone will be
complex, time-consuming and expensive, and may ultimately be
unsuccessful.
Although Critical Therapeutics and Cornerstone both focus on
development and commercialization of pharmaceutical products,
their businesses are different in some material respects.
Critical Therapeutics business has included substantial
reliance on its only marketed products, ZYFLO and ZYFLO CR, and
early stage research and development efforts related to novel
compounds. On the other hand, Cornerstones business
focuses on the pursuit of opportunities with respect to approved
products or known compounds that can generally be developed more
quickly and at less expense. If the merger is consummated,
Cornerstone plans to close the Critical Therapeutics facility in
Lexington, Massachusetts and transfer its assets and business to
86
Cornerstones offices in Cary, North Carolina. The
integration of the Critical Therapeutics and Cornerstone
businesses will be complex, time-consuming and expensive and may
disrupt the combined companys business. The combined
company will need to overcome significant challenges in order to
realize any benefits or synergies from the merger. These
challenges include the timely, efficient and successful
execution of a number of post-merger events, including:
|
|
|
|
|
integrating the operations and technologies of the two
companies; and
|
|
|
|
retaining strategic business partners of each company and
attracting new strategic business partners.
|
Cornerstone expects that the combined company will incur
significant costs integrating Cornerstones and Critical
Therapeutics operations, products and personnel. These may
include costs associated with:
|
|
|
|
|
employee redeployment, relocation or severance;
|
|
|
|
conversion of information systems;
|
|
|
|
combining development, regulatory, manufacturing and commercial
teams and processes;
|
|
|
|
reorganization of facilities; and
|
|
|
|
relocation or disposition of excess equipment.
|
While it is currently unknown how much time will be required to
integrate Cornerstone and Critical Therapeutics, some
integration activities may take longer than one year. Neither
Critical Therapeutics nor Cornerstone has received any
notifications from third parties of their intention to terminate
a material agreement or defer or delay a decision as a result of
the merger. If a third party did terminate a material agreement
or defer or delay a decision as a result of the merger, any such
termination, deferral or delay could have a material adverse
effect on the combined companys results of operations and
financial condition.
If the
combined company does not successfully integrate Critical
Therapeutics and Cornerstones business operations
following the consummation of the merger, the anticipated
benefits of the merger may not be fully realized or may not
occur for an extended period of time.
If the combined company is unable to successfully integrate the
two companies business operations following the
consummation of the merger, the following could occur:
|
|
|
|
|
the combined companys ongoing business could be disrupted
and its management could be distracted;
|
|
|
|
the combined companys financial and managerial controls
and reporting systems and procedures could be strained;
|
|
|
|
the combined company could experience unanticipated expenses and
potential delays related to integration of the operations,
technology and other resources of the two companies;
|
|
|
|
the combined companys relationships with employees,
suppliers and customers as a result of any integration of new
management personnel could be impaired;
|
|
|
|
the combined company could experience greater than anticipated
costs and expenses related to restructuring, including employee
severance or relocation costs and costs related to vacating
leased facilities; and
|
|
|
|
potential unknown or currently unquantifiable liabilities
associated with the merger and the combined operations could
occur.
|
The combined company may not succeed in addressing these risks
or any other problems encountered in connection with the merger.
The inability to successfully integrate the operations,
technology and personnel of Critical Therapeutics and
Cornerstone, or any significant delay in achieving integration,
could have a material
87
adverse effect on the combined company after the merger and, as
a result, on the market price of the combined companys
common stock.
The
combined companys stock price may be volatile, and the
market price of its common stock may drop following the
merger.
The market price of the combined companys common stock
could be subject to significant fluctuations following the
merger. Some of the factors that may cause the market price of
the combined companys common stock to fluctuate include,
but are not limited to:
|
|
|
|
|
the results of the combined companys current and any
future clinical trials;
|
|
|
|
the results of ongoing preclinical studies and planned clinical
trials of the combined companys preclinical product
candidates;
|
|
|
|
the entry into, or termination of, key agreements, including key
strategic alliance agreements;
|
|
|
|
the results and timing of regulatory reviews relating to the
approval of the combined companys product candidates;
|
|
|
|
the initiation of, material developments in or conclusion of
litigation to enforce or defend any of the combined
companys intellectual property rights;
|
|
|
|
failure of any of the combined companys product
candidates, if approved, to achieve commercial success;
|
|
|
|
general and industry-specific economic conditions that may
affect the combined companys research and development
expenditures;
|
|
|
|
the results of clinical trials conducted by others on products
that would compete with the combined companys product
candidates;
|
|
|
|
issues in manufacturing the combined companys product
candidates or any approved products;
|
|
|
|
the loss of key employees;
|
|
|
|
the introduction of technological innovations or new commercial
products by competitors of the combined company;
|
|
|
|
changes in estimates or recommendations by securities analysts,
if any, who cover the combined companys common stock;
|
|
|
|
future sales of the combined companys common stock;
|
|
|
|
changes in the structure of health care payment systems; and
|
|
|
|
period-to-period fluctuations in the combined companys
financial results.
|
Moreover, the stock markets in general have experienced
substantial volatility that has often been unrelated to the
operating performance of individual companies. These broad
market fluctuations may also adversely affect the trading price
of the combined companys common stock.
In the past, following periods of volatility in the market price
of a companys securities, stockholders have often
instituted class action securities litigation against those
companies. Such litigation, if instituted, could result in
substantial costs and diversion of management attention and
resources, which could significantly harm the combined
companys financial condition, results of operations and
reputation.
88
Insiders
will have substantial control over the combined company and
could delay or prevent a change in corporate control, including
a transaction in which the combined companys stockholders
could sell or exchange their shares for a premium.
As of September 15, 2008, Cornerstones directors,
executive officers and 10% or greater stockholders, together
with their affiliates, to Cornerstones knowledge,
beneficially owned, in the aggregate, approximately 71% of
Cornerstones outstanding common stock, without giving
effect to shares of Cornerstones outstanding common stock
issuable to Carolina Pharmaceuticals upon the exchange or
conversion of principal or interest amounts under the Carolina
Note into shares of Cornerstones common stock prior to the
effective time of the merger pursuant to a noteholder agreement
between Carolina Pharmaceuticals and Critical Therapeutics.
Assuming that the merger occurred on this date, these persons
would beneficially own, in the aggregate, approximately 51% of
the outstanding common stock of the combined company, including
any shares of the common stock of the combined company issuable
in the merger in exchange for shares of Cornerstones
outstanding common stock to be issued to Carolina
Pharmaceuticals upon the exchange or conversion of principal or
interest amounts under the Carolina Note into shares of
Cornerstones common stock prior to the effective time of
the merger pursuant to the noteholder agreement between Carolina
Pharmaceuticals and Critical Therapeutics. As a result,
Cornerstones directors, executive officers and 10% or
greater stockholders, together with their affiliates, if acting
together, may have the ability to affect the outcome of matters
submitted to the combined companys stockholders for
approval, including the election and removal of directors and
any merger, consolidation or sale of all or substantially all of
its assets. In addition, these persons, acting together, may
have the ability to control the combined companys
management and affairs. Accordingly, this concentration of
ownership may harm the value of the combined companys
common stock by:
|
|
|
|
|
delaying, deferring or preventing a change in control;
|
|
|
|
impeding a merger, consolidation, takeover or other business
combination; or
|
|
|
|
discouraging a potential acquirer from making an acquisition
proposal or otherwise attempting to obtain control.
|
The
combined companys management will be required to devote
substantial time to comply with public company
regulations.
As a public company, the combined company will incur significant
legal, accounting and other expenses that Cornerstone did not
incur as a private company, although Critical Therapeutics has
been incurring such costs since its initial public offering. In
addition, the Sarbanes-Oxley Act, as well as rules subsequently
implemented by the SEC and NASDAQ, impose various requirements
on public companies, including with respect to corporate
governance practices. The combined companys management and
other personnel do not have substantial experience complying
with the requirements applicable to public companies and will
need to devote a substantial amount of time to these
requirements. Moreover, these rules and regulations will
increase the combined companys legal and financial
compliance costs relative to those of Cornerstone and will make
some activities more time-consuming and costly.
In addition, the Sarbanes-Oxley Act requires, among other
things, that the combined companys management maintain
adequate disclosure controls and procedures and internal control
over financial reporting. In particular, the combined company
must perform system and process evaluation and testing of its
internal control over financial reporting to allow management
and, as applicable, the combined companys independent
registered public accounting firm to report on the effectiveness
of its internal control over financial reporting, as required by
Section 404 of the Sarbanes-Oxley Act. The combined
companys compliance with Section 404 will require it
to incur substantial accounting and related expenses and expend
significant management efforts. The combined company will need
to hire additional accounting and financial staff to satisfy the
ongoing requirements of Section 404. Moreover, if the
combined company is not able to comply with the requirements of
Section 404, or if the combined company or its independent
registered public accounting firm identifies deficiencies in its
internal control over financial reporting that are deemed to be
material weaknesses, the combined companys financial
reporting could be unreliable and misinformation could be
disseminated to the
89
public. Any failure to develop or maintain effective internal
control over financial reporting or difficulties encountered in
implementing or improving the combined companys internal
control over financial reporting could harm the combined
companys operating results and prevent it from meeting its
reporting obligations. Ineffective internal controls also could
cause the combined companys stockholders and potential
investors to lose confidence in its reported financial
information, which would likely have a negative effect on the
trading price of the combined companys common stock. In
addition, investors relying upon this misinformation could make
an uninformed investment decision, and the combined company
could be subject to sanctions or investigations by the SEC,
NASDAQ or other regulatory authorities.
The
combined company may incur losses for the foreseeable future,
and might never achieve profitability.
Critical Therapeutics has experienced significant operating
losses in each year since its inception in 2000, and Cornerstone
experienced operating losses from its inception in 2004 and has
only been profitable beginning in 2007. The combined company may
never become profitable, even if the combined company is able to
commercialize additional products. The combined company will
need to conduct significant development, testing and regulatory
compliance activities that, together with projected general and
administrative expenses, which may result in substantial
operating losses. Even if the combined company does achieve
profitability, it may not be able to sustain or increase
profitability on a quarterly or annual basis.
Anti-takeover
provisions in the combined companys charter documents and
under Delaware law could prevent or frustrate attempts by the
combined companys stockholders to change the combined
companys management or board of directors and hinder
efforts by a third party to acquire a controlling interest in
the combined company.
The combined company will be incorporated in Delaware.
Anti-takeover provisions of Delaware law and the combined
companys charter documents may make a change in control
more difficult, even if the stockholders desire a change in
control. For example, anti-takeover provisions to which the
combined company will be subject include provisions in the
combined companys bylaws and certificate of incorporation
providing that, except as otherwise required by law, special
meetings of the stockholders may be called only by the combined
companys chairman of the board of directors, the chief
executive officer, the president (if the president is different
than the chief executive officer) or the board of directors and
that stockholders may not take action by written consent and
provisions in the combined companys bylaws providing for
the classification of the combined companys board of
directors.
Additionally, the combined companys board of directors
will have the authority to issue up to 5,000,000 shares of
preferred stock and to determine the terms of those shares of
stock without any further action by the combined companys
stockholders. The rights of holders of the combined
companys common stock are subject to the rights of the
holders of any preferred stock that the combined company issues.
As a result, the combined companys issuance of preferred
stock could cause the market value of the combined
companys common stock to decline and could make it more
difficult for a third party to acquire a majority of the
combined companys outstanding voting stock.
Delaware law also prohibits a corporation from engaging in a
business combination with any holder of 15% or more of its
capital stock until the holder has held the stock for three
years unless, among other possibilities, the board of directors
approves the transaction. The combined companys board of
directors may use this provision to prevent changes in the
combined companys management. Also, under applicable
Delaware law, the combined companys board of directors may
adopt additional anti-takeover measures in the future.
90
FORWARD-LOOKING
STATEMENTS
This proxy statement/prospectus includes forward-looking
statements of Critical Therapeutics within the meaning of
Section 21E of the Exchange Act, which is applicable to
Critical Therapeutics, but not Cornerstone, because Critical
Therapeutics, unlike Cornerstone, is a public company subject to
the reporting requirements of the Exchange Act. For this
purpose, any statements contained herein, other than statements
of historical fact, including statements regarding the proposed
merger with Cornerstone, including the expected timetable for
completing the transaction; future financial and operating
results, including targeted product milestones; benefits and
synergies of the transaction; future opportunities of the
combined company; future sales and marketing efforts for
currently marketed products; possible therapeutic benefits and
market acceptance of currently marketed products or product
candidates; the progress and timing of product development
programs and related trials; the potential efficacy of product
candidates; and the strategy, projected costs, prospects, plans
and objectives of management, may be forward-looking statements
under the provisions of The Private Securities Litigation Reform
Act of 1995. In this proxy statement/prospectus, words such as
anticipate, believe, could,
estimate, expect, intend,
may, plan, project,
should, target, will,
would or other words that convey uncertainty of
future events or outcomes are used to identify these
forward-looking statements. Actual results may differ materially
from those indicated by such forward-looking statements as a
result of various important factors, including critical
accounting estimates and risks relating to: the ability to
consummate the proposed merger; the ability to successfully
market and sell currently marketed products and product
candidates, including the success of
co-promotion
arrangements; the ability to transition Critical
Therapeutics management team effectively; the ability to
develop and maintain the necessary sales, marketing,
distribution and manufacturing capabilities to commercialize
currently marketed products; patient, physician and third-party
payor acceptance of currently marketed products as safe and
effective therapeutic products; adverse side effects experienced
by patients; the heavy dependence on the commercial success of a
small number of currently marketed products; the ability to
maintain regulatory approvals to market currently marketed
products; the ability to successfully enter into additional
strategic co-promotion, collaboration or licensing transactions
on favorable terms, if at all; the ability to maintain
compliance with NASDAQ listing standards; conducting clinical
trials, including difficulties or delays in the completion of
patient enrollment, data collection or data analysis; the
results of preclinical studies and clinical trials with respect
to products under development and whether such results will be
indicative of results obtained in later clinical trials; the
ability to obtain the substantial additional funding required to
conduct development and commercialization activities; Critical
Therapeutics dependence on its strategic collaboration
with MedImmune; and the ability to obtain, maintain and enforce
patent and other intellectual property protection for currently
marketed products and product candidates. These and other risks
are described in greater detail in the section entitled
Risk Factors beginning on page 24 of this proxy
statement/prospectus. If one or more of these factors
materialize, or if any underlying assumptions prove incorrect,
actual results, performance or achievements may vary materially
from any future results, performance or achievements expressed
or implied by these forward-looking statements. In addition, any
forward-looking statements in this proxy statement/prospectus
represent Critical Therapeutics views only as of the date
of this proxy statement/prospectus and should not be relied upon
as representing Critical Therapeutics views as of any
subsequent date. Critical Therapeutics anticipates that
subsequent events and developments will cause its views to
change. However, while Critical Therapeutics may elect to update
these forward-looking statements publicly at some point in the
future, Critical Therapeutics specifically disclaims any
obligation to do so, except as may be required by law, whether
as a result of new information, future events or otherwise.
Critical Therapeutics forward-looking statements generally
do not reflect the potential impact of any future acquisitions,
mergers, dispositions, joint ventures or investments it may
make. In particular, unless otherwise stated or the context
otherwise requires, Critical Therapeutics has prepared this
proxy statement/prospectus as if it were going to remain an
independent, standalone company. If Critical Therapeutics
consummates the merger with Cornerstone, the descriptions of its
strategy, future operations and financial position, future
revenues, projected costs and prospects and the plans and
objectives of management in this proxy statement/prospectus may
no longer be applicable.
91
THE
SPECIAL MEETING OF CRITICAL THERAPEUTICS
STOCKHOLDERS
Date,
Time and Place
The special meeting of Critical Therapeutics stockholders
will be held at 10:00 a.m., local time, on October 31,
2008, at the offices of Wilmer Cutler Pickering Hale and Dorr
LLP, located at 60 State Street, Boston, Massachusetts 02109.
Critical Therapeutics is sending this proxy statement/prospectus
to its stockholders in connection with the solicitation of
proxies by Critical Therapeutics board of directors for
use at the special meeting and any adjournments or postponements
of the special meeting. This proxy statement/prospectus is first
being furnished to Critical Therapeutics stockholders on
or about October 6, 2008.
Purposes
of the Special Meeting
The purposes of the special meeting are to consider and act upon
the following matters:
|
|
|
|
1.
|
To approve the issuance of Critical Therapeutics common
stock pursuant to the Agreement and Plan of Merger, dated as of
May 1, 2008, by and among Critical Therapeutics, a wholly
owned subsidiary of Critical Therapeutics, and Cornerstone, as
described in this proxy statement/prospectus. A copy of the
merger agreement is attached as Annex A to this
proxy statement/prospectus.
|
|
|
2.
|
To approve an amendment to Critical Therapeutics
certificate of incorporation to provide for a reverse stock
split of Critical Therapeutics common stock, as described
in this proxy statement/prospectus. A copy of the proposed
amendment is attached as Annex B to this proxy
statement/prospectus.
|
|
|
3.
|
To approve an amendment to Critical Therapeutics
certificate of incorporation to change the name of Critical
Therapeutics to Cornerstone Therapeutics Inc., as
described in this proxy statement/prospectus. A copy of the
proposed amendment is attached as Annex C to this
proxy statement/prospectus.
|
|
|
4.
|
To consider and vote upon an adjournment of the special meeting,
if necessary, if a quorum is present, to solicit additional
proxies if there are not sufficient votes in favor of
Proposals 1, 2 and 3.
|
Stockholders will also consider and act on any other matters as
may properly come before the special meeting or any adjournment
or postponement thereof.
Recommendation
of Critical Therapeutics Board of Directors
CRITICAL THERAPEUTICS BOARD OF DIRECTORS HAS DETERMINED
AND BELIEVES THAT THE ISSUANCE OF SHARES OF CRITICAL
THERAPEUTICS COMMON STOCK IN THE MERGER, AS DESCRIBED IN
THIS PROXY STATEMENT/PROSPECTUS, IS ADVISABLE, FAIR TO AND IN
THE BEST INTERESTS OF CRITICAL THERAPEUTICS AND ITS STOCKHOLDERS
AND HAS UNANIMOUSLY APPROVED SUCH PROPOSAL. CRITICAL
THERAPEUTICS BOARD OF DIRECTORS UNANIMOUSLY RECOMMENDS
THAT CRITICAL THERAPEUTICS STOCKHOLDERS VOTE
FOR PROPOSAL 1 TO APPROVE THE ISSUANCE OF
SHARES OF CRITICAL THERAPEUTICS COMMON STOCK IN THE
MERGER.
CRITICAL THERAPEUTICS BOARD OF DIRECTORS HAS DETERMINED
AND BELIEVES THAT THE AMENDMENT TO CRITICAL THERAPEUTICS
CERTIFICATE OF INCORPORATION TO EFFECT THE REVERSE STOCK SPLIT,
AS DESCRIBED IN THIS PROXY STATEMENT/PROSPECTUS, IS ADVISABLE,
FAIR TO AND IN THE BEST INTERESTS OF CRITICAL THERAPEUTICS AND
ITS STOCKHOLDERS AND HAS UNANIMOUSLY APPROVED SUCH PROPOSAL.
CRITICAL THERAPEUTICS BOARD OF DIRECTORS UNANIMOUSLY
RECOMMENDS THAT CRITICAL THERAPEUTICS STOCKHOLDERS VOTE
FOR PROPOSAL 2 TO AMEND CRITICAL
THERAPEUTICS CERTIFICATE OF INCORPORATION TO EFFECT THE
REVERSE STOCK SPLIT.
CRITICAL THERAPEUTICS BOARD OF DIRECTORS HAS DETERMINED
AND BELIEVES THAT THE AMENDMENT TO CRITICAL THERAPEUTICS
CERTIFICATE OF INCORPORATION
92
TO CHANGE ITS NAME TO CORNERSTONE THERAPEUTICS
INC. IS ADVISABLE, FAIR TO AND IN THE BEST INTERESTS OF
CRITICAL THERAPEUTICS AND ITS STOCKHOLDERS AND HAS UNANIMOUSLY
APPROVED SUCH PROPOSAL. CRITICAL THERAPEUTICS BOARD OF
DIRECTORS UNANIMOUSLY RECOMMENDS THAT CRITICAL
THERAPEUTICS STOCKHOLDERS VOTE FOR
PROPOSAL 3 TO APPROVE THE NAME CHANGE.
CRITICAL THERAPEUTICS BOARD OF DIRECTORS HAS DETERMINED
AND BELIEVES THAT ADJOURNING THE SPECIAL MEETING, IF NECESSARY,
IF A QUORUM IS PRESENT, TO SOLICIT ADDITIONAL PROXIES IF THERE
ARE NOT SUFFICIENT VOTES IN FAVOR OF PROPOSALS 1, 2 AND 3
IS ADVISABLE, FAIR TO AND IN THE BEST INTERESTS OF CRITICAL
THERAPEUTICS AND ITS STOCKHOLDERS AND HAS UNANIMOUSLY APPROVED
SUCH PROPOSAL. CRITICAL THERAPEUTICS BOARD OF DIRECTORS
UNANIMOUSLY RECOMMENDS THAT CRITICAL THERAPEUTICS
STOCKHOLDERS VOTE FOR PROPOSAL 4 TO ADJOURN THE
SPECIAL MEETING, IF NECESSARY, IF A QUORUM IS PRESENT, TO
SOLICIT ADDITIONAL PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN
FAVOR OF PROPOSALS 1, 2 AND 3.
Record
Date and Voting Power
Only holders of record of Critical Therapeutics common
stock at the close of business on the record date,
September 29, 2008, are entitled to notice of, and to vote
at, the special meeting. There were approximately
76 holders of record of Critical Therapeutics common
stock at the close of business on the record date. Because many
of such shares are held by banks, brokers and other nominees on
behalf of stockholders, Critical Therapeutics is unable to
estimate the total number of stockholders represented by these
record holders. At the close of business on the record date,
43,332,598 shares of Critical Therapeutics common
stock were issued and outstanding. Each share of Critical
Therapeutics common stock issued and outstanding on the
record date entitles the holder thereof to one vote on each
matter submitted for stockholder approval. See Principal
Stockholders of Critical Therapeutics beginning on
page 344 of this proxy statement/prospectus for
information regarding persons known to the management of
Critical Therapeutics to be the beneficial owners of more than
5% of the outstanding shares of Critical Therapeutics
common stock.
Voting
and Revocation of Proxies
The proxy accompanying this proxy statement/prospectus is
solicited on behalf of Critical Therapeutics board of
directors for use at the special meeting.
If you are a stockholder of record of Critical Therapeutics as
of the record date referred to above, you may vote in person at
the special meeting or vote by proxy over the Internet, by
telephone or using the enclosed proxy card. Whether or not you
plan to attend the special meeting, Critical Therapeutics urges
you to vote by proxy to ensure your vote is counted. You may
still attend the special meeting and vote in person if you have
already voted by proxy.
If your shares are registered directly in your name, you may
vote:
|
|
|
|
|
Over the Internet. Go to the web site of
Critical Therapeutics tabulator, BNY Mellon Shareowner
Services, at
http://www.proxyvoting.com/crtx
and follow the instructions you will find there. You must
specify how you want your shares voted or your Internet vote
cannot be completed and you will receive an error message. Your
shares will be voted according to your instructions.
|
|
|
|
By Telephone. Call
(866) 540-5760
toll-free from the United States or Canada and follow the
instructions. You must specify how you want your shares voted
and confirm your vote at the end of the call or your telephone
vote cannot be completed. Your shares will be voted according to
your instructions.
|
|
|
|
By Mail. Complete, date and sign the enclosed
proxy card and mail it in the enclosed postage-paid envelope to
BNY Mellon Shareowner Services. Your proxy will be voted
according to your instructions.
|
93
|
|
|
|
|
If you do not specify how you want your shares voted, they will
be voted as recommended by Critical Therapeutics board of
directors.
|
|
|
|
|
|
In Person at the Meeting. If you attend the
meeting, you may deliver your completed proxy card in person or
you may vote by completing a ballot, which will be available at
the meeting.
|
If your shares are held in street name for your
account by a bank broker or other nominee, you may vote:
|
|
|
|
|
Over the Internet or By Telephone. You will
receive instructions from your broker or other nominee if you
are permitted to vote over the Internet or by telephone.
|
|
|
|
By Mail. You will receive instructions from
your broker or other nominee explaining how to vote your shares.
|
|
|
|
In Person at the Meeting. Contact the broker
or other nominee that holds your shares to obtain a
brokers proxy card and bring it with you to the meeting.
A brokers proxy is not the form of proxy
enclosed with this proxy statement. You will not be able to vote
shares you hold in street name at the meeting unless
you have a proxy from your broker issued in your name giving you
the right to vote the shares.
|
All properly executed proxies that are not revoked will be voted
at the special meeting and at any adjournments or postponements
of the special meeting in accordance with the instructions
contained in the proxy. If a holder of Critical
Therapeutics common stock executes and returns a proxy and
does not specify otherwise, the shares represented by that proxy
will be voted FOR Proposal 1 to approve the
issuance of shares of Critical Therapeutics common stock
in the merger; FOR Proposal 2 to approve an
amendment to Critical Therapeutics certificate of
incorporation to effect the reverse stock split described in
this proxy statement/prospectus; FOR Proposal 3
to approve an amendment to Critical Therapeutics
certificate of incorporation to change the name of Critical
Therapeutics to Cornerstone Therapeutics Inc.; and
FOR Proposal 4 to adjourn the special meeting,
if necessary, if a quorum is present, to solicit additional
proxies if there are not sufficient votes in favor of
Proposals 1, 2 and 3 in accordance with the recommendation
of Critical Therapeutics board of directors.
Any Critical Therapeutics stockholder of record voting by
proxy, other than those stockholders who have executed a voting
agreement and irrevocable proxy, has the right to revoke the
proxy at any time before the polls close at the special meeting
by sending a written notice stating that it would like to revoke
its proxy to the Secretary of Critical Therapeutics, by voting
again over the Internet or by telephone, by providing a duly
executed proxy card bearing a later date than the proxy being
revoked or by attending the special meeting and voting in
person. Attendance alone at the special meeting will not revoke
a proxy. A beneficial owner of Critical Therapeutics
common stock that holds shares in street name must
follow directions received from the bank, broker or other
nominee that holds the shares to change its voting instructions.
Quorum
and Required Vote
The presence, in person or represented by proxy, at the special
meeting of the holders of a majority of the shares of Critical
Therapeutics common stock outstanding and entitled to vote
at the special meeting is necessary to constitute a quorum at
the meeting. If Critical Therapeutics stockholders do not
vote by proxy or in person at the special meeting, the shares of
common stock of such Critical Therapeutics stockholders
will not be counted as present for the purpose of determining a
quorum. If a quorum is not present at the special meeting,
Critical Therapeutics expects that the special meeting will be
adjourned or postponed to solicit additional proxies.
Abstentions and broker non-votes will be counted as present for
purposes of determining the existence of a quorum. A
broker non-vote occurs when a broker is not
permitted to vote because the broker does not have specific
voting instructions from the beneficial owner of the shares.
A description of the vote required to approve each proposal
being submitted to a vote of the Critical Therapeutics
stockholders is included with the description of each proposal
beginning on page 152. For proposals requiring the approval
of holders of a majority of the outstanding shares of Critical
Therapeutics common stock, a failure to vote by proxy or
in person at the special meeting, or an abstention, vote
withheld
94
or broker non-vote for such proposals, will have the
same effect as a vote against the approval of such proposals.
For proposals requiring the approval of a majority of the shares
of Critical Therapeutics common stock present in person or
represented by proxy and voting on such matter at the special
meeting, a failure to submit a proxy card or vote at the special
meeting, or an abstention, vote withheld or broker
non-votes will have no effect on the outcome of such
proposals.
Solicitation
of Proxies
In addition to solicitation by mail, the directors, officers,
employees and agents of Critical Therapeutics may solicit
proxies from Critical Therapeutics stockholders by
telephone, other electronic means or in person. Directors,
officers, employees and agents of Critical Therapeutics will not
receive any additional compensation for their services, but
Critical Therapeutics will reimburse them for their
out-of-pocket expenses. Critical Therapeutics also will make
arrangements with banks, brokers, nominees, custodians and
fiduciaries who are record holders of Critical
Therapeutics common stock for the forwarding of
solicitation materials to the beneficial owners of Critical
Therapeutics common stock. Critical Therapeutics will
reimburse these banks, brokers, nominees, custodians and
fiduciaries for the reasonable out-of-pocket expenses they incur
in connection with the forwarding of solicitation materials and
in obtaining voting instructions from these owners.
Critical Therapeutics has retained Morrow & Co., LLC,
a proxy solicitation firm, to assist in the solicitation of
proxies by mail, telephone or other electronic means or in
person for a fee of approximately $5,500, plus disbursements and
a fee for each completed call.
Other
Matters
As of the date of this proxy statement/prospectus, Critical
Therapeutics board of directors does not know of any
business to be presented at the special meeting other than as
set forth in the notice accompanying this proxy
statement/prospectus. If any other matters should properly come
before the special meeting, or at any adjournment or
postponement of the special meeting, it is intended that the
shares represented by proxies will be voted with respect to such
matters in accordance with the judgment of the persons voting
the proxies.
95
THE
MERGER
This section and the section entitled The Merger
Agreement beginning on page 137 of this proxy
statement/prospectus describe the material aspects of the
merger, including the merger agreement. While Critical
Therapeutics believes that this description covers the material
terms of the merger and the merger agreement, it may not contain
all of the information that is important to you. You should read
carefully this entire proxy statement/prospectus, including the
merger agreement, which is attached as Annex A to this
proxy statement/prospectus, and the other documents to which
Critical Therapeutics has referred to or incorporated by
reference herein. For a more detailed description of where you
can find those other documents, please see the section entitled
Where You Can Find More Information beginning on
page 352 of this proxy statement/prospectus.
Background
of the Merger
Critical
Therapeutics Background of the Merger
Critical Therapeutics has regularly evaluated different
strategies for improving its competitive position and enhancing
stockholder value. As part of these evaluations, Critical
Therapeutics has, from time to time, considered various
potential strategic alternatives to pursuing its business plan,
including acquisitions, divestitures, collaborations, business
combinations and other strategic transactions.
In May 2006, Critical Therapeutics board of directors and
management began exploring methods by which to improve Critical
Therapeutics strategic position in the industry and
enhance stockholder value. In September 2006, Critical
Therapeutics engaged Lazard to assist in this process. As part
of this September 2006 engagement, Critical Therapeutics
retained Lazard as its sole financial advisor in connection with
a potential strategic transaction, such as a merger, as well in
connection with a potential alternative transaction, such as a
business development transaction, licensing or joint venture
transaction. In addition, Critical Therapeutics agreed to
appoint Lazard or its affiliate as a lead-manager or
lead-placement agent in connection with a public or private
financing. Pursuant to this September 2006 engagement, Critical
Therapeutics instructed Lazard to act within the scope of the
engagement letter generally and specifically instructed Lazard
to commence its search in identifying potential counterparties
to both a potential strategic transaction as well as to a
potential alternative transaction.
During the remainder of 2006 and early 2007, Critical
Therapeutics management, with the assistance of Lazard,
assessed Critical Therapeutics long-term prospects, market
position and possible strategic alternatives, including a merger
or similar strategic transaction. During the period between
September 2006 and March 2007, Critical Therapeutics,
directly or through Lazard, contacted a total of
82 companies to assess whether those companies would be
interested in discussing a possible merger or similar strategic
transaction with Critical Therapeutics. As a result of the
foregoing contacts, preliminary discussions were held with
12 companies concerning a possible merger or similar
strategic transaction.
By March 2007, none of the companies that were contacted as part
of this strategic process were interested in pursuing a merger
or similar strategic transaction at that time. Accordingly,
Critical Therapeutics decided to remain independent and to enter
into a co-promotion agreement with DEY for ZYFLO and ZYFLO CR.
Following the decision to enter into the co-promotion agreement
with DEY, Critical Therapeutics secured FDA approval for ZYFLO
CR in May 2007 and commercially launched the product in
September 2007 with 42 sales representatives. During this
time, sales of ZYFLO remained relatively flat until the launch
of ZYFLO CR despite the commencement of co-promotional detailing
by DEY in May 2007 with an additional 200 sales representatives.
From March 2007 through September 2007, Critical Therapeutics
continued to consider other potential strategic transactions.
At a regularly scheduled board meeting on September 10,
2007, Critical Therapeutics board of directors and
management reviewed the status of Critical Therapeutics
commercial and research and development activities, including
the risks and benefits of its upcoming launch of ZYFLO CR, as
well as its financial position, long-term prospects, financing
options and ongoing strategic and business development
opportunities. Members of Critical Therapeutics management
reviewed the status of ongoing discussions with potential
strategic partners as well as other business development
opportunities.
96
At a regularly scheduled board meeting on October 4, 2007,
Critical Therapeutics board of directors and management
reviewed Critical Therapeutics strategy, discussed
potential options for increasing stockholder value and reviewed
the status of ongoing discussions with potential strategic
partners. Critical Therapeutics board noted that most of
Critical Therapeutics competitors were significantly
larger companies, with more resources, more product offerings
and larger sales forces. Critical Therapeutics board was
concerned that, notwithstanding the recent commercial launch of
ZYFLO CR, the company would need to create a larger set of
resources, including products and pipeline, to create a
sustainable business model for long-term success as an
independent, standalone company. Critical Therapeutics
board concluded that, given, among other things, the overall
difficulty for life sciences companies to obtain financing,
there were significant risks to Critical Therapeutics
long-term success as an independent, standalone company and that
stockholders interests would be best served if Critical
Therapeutics began to explore opportunities for a range of
potential strategic transactions. On October 5, 2007,
Critical Therapeutics board of directors further discussed
the possible benefit of exploring various strategic alternatives
with the assistance of a financial advisor. Based upon
Lazards existing knowledge of Critical Therapeutics, as
well as Lazards reputation, background and experience in
the industry and in mergers and acquisitions generally, Critical
Therapeutics board once again formally engaged Lazard,
effective October 12, 2007, to advise it in considering
potential strategic alternatives. As part of this October 2007
engagement, Critical Therapeutics retained Lazard as its primary
investment banker in connection with potential strategic
transactions, such as a merger or acquisition transaction.
Pursuant to this October 2007 engagement, Critical Therapeutics
instructed Lazard to act within the scope of the engagement
letter generally and specifically instructed Lazard to commence
its search in identifying potential counterparties to a
potential merger or acquisition. In contrast to its September
2006 engagement, Critical Therapeutics did not appoint Lazard as
a financial advisor in connection with a potential licensing or
business development transaction or in connection with a public
or private financing.
In October 2007, Critical Therapeutics began making and
receiving general inquiries to gauge interest in potential
business combinations with companies seeking to gain access to a
commercial-stage respiratory therapeutics business in the United
States. Critical Therapeutics management and board of
directors, with the assistance of Lazard, identified public and
private companies that might fit Critical Therapeutics
strategic plans, focusing on specialty pharmaceutical companies
potentially interested in acquiring Critical Therapeutics
commercial assets, as well as research and development companies
with clinical-stage assets in selected therapeutic areas
potentially interested in merging with Critical Therapeutics.
On November 8, 2007, Critical Therapeutics publicly
announced that it was evaluating a range of strategic
alternatives that could result in potential changes to its
current business strategy and future operations, including the
sale or divestiture of certain assets, the merger or sale of the
company or other strategic transactions.
During the period between October 2007 and April 2008, Critical
Therapeutics conducted a targeted process in which a total of
36 companies were contacted to assess whether those
companies would be interested in discussing a possible merger,
acquisition or other strategic transaction with Critical
Therapeutics. In connection with these discussions, Critical
Therapeutics entered into confidentiality agreements with a
total of 19 companies, including Cornerstone, for the
purpose of exchanging non-public information to facilitate
discussions. As a result of this process, preliminary
discussions were held with nine companies concerning a possible
merger transaction with or acquisition of Critical Therapeutics.
Beginning in September 2007, Critical Therapeutics engaged in
substantive discussions regarding a potential merger with a
privately held venture-backed biotechnology company without any
currently marketed products and with two product candidates in
Phase II clinical development for gastrointestinal
disorders, or Company X. Beginning in October 2007,
Critical Therapeutics engaged in substantive discussions
regarding a potential merger with a privately held
venture-backed biotechnology company without any currently
marketed products and with two product candidates in
Phase II clinical development for respiratory diseases, or
Company Y. Beginning in December 2007, Critical Therapeutics
engaged in substantive discussions regarding a potential
acquisition of Critical Therapeutics in a stock-for-stock merger
with a publicly traded biotechnology company with a commercial
organization and several FDA-approved marketed drugs, or Company
Z. Company Z had a
97
market capitalization during the period from December 2007 to
March 2008 in the range of approximately $40 million to
$200 million.
In connection with this process, Critical Therapeutics also
prepared an electronic data room containing documents related to
Critical Therapeutics material legal contracts, corporate
records, financial information, sales and marketing materials,
corporate policies and procedures, insurance information and
information regarding products and product candidates, including
research data, clinical trial reports, regulatory filings and
correspondence and patents and patent applications. In
connection with discussions regarding a possible merger or
acquisition between October 2007 and May 2008, Critical
Therapeutics granted access to this electronic data room to a
total of eight companies, each of which had entered into a
confidentiality agreement with Critical Therapeutics, including
Cornerstone, Company X, Company Y and Company Z. In addition, in
connection with such discussions during this period, Critical
Therapeutics was granted access to the electronic data rooms of
Cornerstone, Company X, Company Y and Company Z.
Critical Therapeutics conducted substantive scientific,
commercial and financial due diligence on several of these
companies during this period.
Throughout this period, Critical Therapeutics management
apprised the board of directors of these discussions both
informally and through reports at board meetings. Between
October 1, 2007 and May 1, 2008, Critical
Therapeutics board met 29 times and discussed the
ongoing strategic alternatives review process and discussions
and negotiations with companies as part of this strategic review
process.
On November 20, 2007, Critical Therapeutics board of
directors held a meeting, also attended by members of Critical
Therapeutics management and representatives of Wilmer
Cutler Pickering Hale and Dorr LLP, or WilmerHale, Critical
Therapeutics outside legal counsel, Lazard and outside
diligence consultants, at which the board was briefed on the
ongoing process to identify possible strategic transactions.
Among other matters discussed, the board was updated with
respect to the potential strategic partners that Critical
Therapeutics management, with the assistance of Lazard,
had identified and which Lazard had contacted at the direction
of Critical Therapeutics management or which had contacted
Lazard in response to Critical Therapeutics public
announcement that it was evaluating a range of strategic
alternatives. In addition, the board received an overview of the
development pipeline, commercial potential, business and
operations of Company X and Company Y together with preliminary
terms for a potential transaction with each company. After
discussion, Critical Therapeutics board authorized
management to continue discussions and engage in mutual due
diligence with both companies, while continuing efforts to
identify additional potential strategic partners.
At meetings on December 11 and 12, 2007, Critical
Therapeutics board of directors received an update on the
status of Critical Therapeutics strategic process from
management and Lazard. Management and Critical
Therapeutics outside diligence consultants reviewed with
the board scientific, commercial and financial information on
Company X and Company Y.
In late December 2007, after a number of meetings and
discussions between Critical Therapeutics and Company X
regarding the acquisition process and participating in a
significant mutual due diligence review process, Company X
indicated that it had other business priorities and had decided
not to move forward with a merger with Critical Therapeutics. At
the point discussions with Company X ended, Company X had
preliminarily proposed a transaction in which Critical
Therapeutics stockholders would hold
approximately 35% of the combined company.
In January 2008, after discussions between Critical Therapeutics
and Company Y regarding the acquisition process, participating
in a significant mutual due diligence review process and
conducting negotiations regarding a definitive agreement,
Company Y indicated that it had other business priorities and
had decided not to move forward with a merger with Critical
Therapeutics. At the point discussions with Company Y ended,
Company Y had preliminarily proposed a transaction in which
Critical Therapeutics stockholders would hold
approximately 50% of the combined company.
During the fourth quarter of 2007 and the first quarter of 2008,
sales of ZYFLO CR were lower than anticipated. In addition, in
March 2008, Critical Therapeutics began to experience problems
in the supply chain for ZYFLO CR. During this time, Critical
Therapeutics cash position also continued to decrease. In
98
addition, conditions in the national economy and the financial
markets in particular continued to present challenges for life
sciences companies seeking financing. These factors reinforced
the view of Critical Therapeutics board of directors that
concluding the strategic alternatives process as soon as
practical was in the best interests of Critical
Therapeutics stockholders.
On February 14, 2008, Critical Therapeutics board of
directors held a meeting, also attended by members of Critical
Therapeutics management and representatives of WilmerHale
and Lazard, at which the board received an update on the
strategic process, including information regarding the
commercial, clinical and business operations of Company Z.
On February 15, 2008, Craig Collard, President, Chief
Executive Officer and a director of Cornerstone, contacted by
telephone Frank E. Thomas, then President, Chief Executive
Officer and a director of Critical Therapeutics, to discuss the
possibility of a strategic transaction between Cornerstone and
Critical Therapeutics.
On February 20, 2008, Critical Therapeutics and Cornerstone
executed a confidentiality agreement for the purpose of
exchanging non-public information to facilitate discussions
between the two companies. On or after February 20, 2008,
Critical Therapeutics sent a detailed presentation regarding
Critical Therapeutics via
e-mail to
representatives of Cornerstone.
On February 28, 2008, Thomas P. Kelly, Chief Financial
Officer and Senior Vice President of Finance and Corporate
Development of Critical Therapeutics, and Roger Heerman, Vice
President of Sales and Marketing of Critical Therapeutics, held
a telephone conference with Mr. Collard and Brian
Dickson, M.D., Chief Medical Officer of Cornerstone. During
this telephone conference, the parties made presentations to
each other regarding their respective companies and their
businesses.
On March 3, 2008, Cornerstone sent a detailed presentation
regarding Cornerstone via
e-mail to
representatives of Critical Therapeutics and Lazard. Also on
March 3, 2008, Mr. Collard
e-mailed
Mr. Thomas to inform him that Cornerstone was interested in
continuing discussions regarding a transaction with Critical
Therapeutics.
On March 4, 2008, Critical Therapeutics publicly announced
that Mr. Thomas had informed Critical Therapeutics
board of directors that he had resigned as a director effective
March 2, 2008 and was resigning as President and Chief
Executive Officer effective March 31, 2008, and that Trevor
Phillips, Ph.D., Critical Therapeutics Senior Vice
President of Operations and Chief Operating Officer, had been
appointed as a director effective March 4, 2008 and would
become President and Chief Executive Officer of Critical
Therapeutics effective April 1, 2008.
In early March 2008, after many meetings and discussions between
Critical Therapeutics and Company Z regarding the acquisition
process, participating in a significant mutual due diligence
review process and conducting negotiations regarding a
definitive agreement, Company Z indicated that it had other
business priorities and had decided not to move forward with a
merger with Critical Therapeutics. At the point discussions with
Company Z ended, Company Z had preliminarily proposed a
transaction in which Critical Therapeutics stockholders
would receive Company Z common stock with an aggregate market
value of approximately $65 million. Shortly after
discontinuing merger discussions in March 2008, Company Z
experienced significant regulatory setbacks with the FDA and a
significant reduction in its market capitalization.
On March 7, 2008, Mr. Collard, Dr. Dickson and
Alastair McEwan, Chairman of the board of directors of
Cornerstone, traveled to Critical Therapeutics offices in
Lexington, Massachusetts and met with Dr. Phillips,
Mr. Thomas, Mr. Kelly, Mr. Heerman and Roberta
Tucker, Senior Vice President of Regulatory Affairs of Critical
Therapeutics. During this meeting, the managements of both
Cornerstone and Critical Therapeutics made presentations
regarding their respective companies and their businesses.
Representatives of Jefferies & Company, Inc., or
Jefferies, Cornerstones financial advisor, were also
present at this meeting.
Following the meeting on March 7, 2008, Critical
Therapeutics and Cornerstone continued mutual due diligence on
the business, assets and liabilities of each company, including
telephone conferences and review
99
of information contained in each companys electronic
dataroom. In addition, representatives of both companies
management teams and their respective legal and financial
advisors conducted numerous discussions regarding the potential
terms of a transaction.
On March 12, 2008, Dr. Phillips, Mr. Kelly,
Mr. Heerman and Mr. Thomas held a telephone conference
call with Mr. Collard, Mr. McEwan and a representative
of Jefferies regarding the proposed transaction with Cornerstone
and the acquisition process in general.
On March 13, 2008, representatives of the parties
management and financial advisors held a further telephone
conference to discuss the proposed transaction with Cornerstone,
potential deal terms and the acquisition process in general.
On March 17, 2008, Cornerstone sent a letter via
e-mail to
Critical Therapeutics reflecting a non-binding expression of
interest regarding a potential merger with Critical Therapeutics
in which Critical Therapeutics would issue common stock to
Cornerstone stockholders for all of Cornerstones equity
capital. In this letter, Cornerstone preliminarily proposed a
transaction in which Critical Therapeutics stockholders
would hold 34% of the combined company, based on Critical
Therapeutics having a cash balance at closing of at least
$20 million.
Critical Therapeutics board of directors met on
March 20, 2008 in Cambridge, Massachusetts and by
teleconference, together with members of Critical
Therapeutics management and representatives of WilmerHale
and Lazard. At this meeting, representatives of Cornerstone made
a presentation to Critical Therapeutics board regarding a
possible strategic transaction between Cornerstone and Critical
Therapeutics and related matters. Following this presentation,
Cornerstones representatives departed the meeting.
Critical Therapeutics board then continued to discuss a
potential strategic transaction with Cornerstone. As part of
this discussion, Lazard provided an update on the status of the
strategic review process, including recent conversations with
potential strategic partners, and discussed with the board
particular terms of Cornerstones non-binding expression of
interest and tactical perspectives with respect to a potential
transaction with Cornerstone. In addition, Dr. Phillips
made a presentation to the board regarding the potential
transaction and members of management discussed the due
diligence performed on Cornerstone and the strategy, business
and prospects for a combined company. Following this discussion,
Critical Therapeutics board met in executive session
without Critical Therapeutics management, other than
Dr. Phillips, and unanimously agreed to continue to pursue
discussions with Cornerstone and directed management to report
back to the board on their progress.
Following the meeting on March 20, 2008, representatives of
Critical Therapeutics and Cornerstone continued their mutual due
diligence.
On March 21, 2008, Critical Therapeutics sent a letter via
e-mail to
Cornerstone with a response to Cornerstones expression of
interest regarding potential terms of a transaction. In this
letter, Critical Therapeutics preliminarily proposed a
transaction in which Critical Therapeutics stockholders
would hold 35% of the combined company. Critical Therapeutics
also delivered to Cornerstone a detailed due diligence request
list regarding legal, finance and other business matters
relating to Cornerstone.
On March 25, 2008, Jefferies, on behalf of Cornerstone,
sent a letter via
e-mail in
response to Critical Therapeutics letter of March 21,
2008. In that letter, Cornerstone preliminarily proposed a
transaction in which Critical Therapeutics stockholders
would hold 31% of the combined company, based on a projected
cash balance at closing for Critical Therapeutics of
$12 million.
On March 25, 2008, Critical Therapeutics board of
directors held a meeting by telephone conference at which, among
other matters, Dr. Phillips provided the board with an
update regarding the potential transaction with Cornerstone as
well as the status of Critical Therapeutics discussions
with and due diligence regarding other potential strategic
transaction candidates.
Also on March 25, 2008, Critical Therapeutics, Cornerstone
and their respective financial advisors held a telephone
conference to discuss financial projections for each company,
including as described in the section
100
of this proxy statement/prospectus entitled Financial
Projections, and the possible impact that such projections
for each company could have with respect to the combined company.
On March 28, 2008, members of Critical Therapeutics
management attended due diligence meetings at Cornerstones
offices in Cary, North Carolina with Chenyqua Baldwin, Vice
President, Finance of Cornerstone. On March 29, 2008,
members of Critical Therapeutics management attended due
diligence meetings in Cary, North Carolina.
Also on March 28, 2008, Cornerstone sent a letter to
Critical Therapeutics clarifying particular items regarding
potential deal terms, including proposing an exclusivity period
and proposing that the proportion of the combined company that
Critical Therapeutics stockholders would hold would be
variable based on Critical Therapeutics cash balance at
closing.
On March 31, 2008, Critical Therapeutics received a legal
due diligence request list from Cornerstone regarding legal,
finance and other business matters relating to Critical
Therapeutics.
Also on March 31, 2008, Critical Therapeutics board
of directors held a meeting by telephone conference. Also
present at this telephonic meeting were members of Critical
Therapeutics management and representatives of WilmerHale
and Lazard. At this meeting, among other things,
Dr. Phillips provided an update with respect to, and led a
discussion with input from Lazard regarding, Critical
Therapeutics ongoing process of reviewing strategic
alternatives, including the status of discussions with
Cornerstone and with other potential strategic transaction
candidates. The discussions with these other potential strategic
transaction candidates were all at an early stage without any
specific economic terms proposed with respect to a potential
transaction. After extensive discussions, the board determined
that the company should pursue further negotiations with
Cornerstone regarding a possible business combination on a
non-exclusive basis.
On April 8 and 9, 2008, representatives of Cornerstone and
Critical Therapeutics and representatives of Jefferies and
Lazard discussed further financial projections for each company,
including as described in the section of this proxy
statement/prospectus entitled Financial Projections,
and the possible impact that such projections for each company
could have with respect to the combined company.
On April 10, 2008, Critical Therapeutics board of
directors held a meeting in Cambridge, Massachusetts and by
telephone conference. Also present at this meeting were members
of Critical Therapeutics management and representatives of
WilmerHale and Lazard, as well as Mr. Collard,
Mr. McEwan and Dr. Dickson of Cornerstone and
representatives of Jefferies. During the meeting,
Cornerstones representatives made presentations to
Critical Therapeutics board regarding a possible strategic
transaction between Critical Therapeutics and Cornerstone.
Following these presentations, Cornerstones
representatives departed the meeting. Critical
Therapeutics board then continued to discuss a potential
strategic transaction with Cornerstone. Following this
discussion, Dr. Phillips updated Critical
Therapeutics board regarding the status of discussions
with other potential strategic transaction candidates, all of
which were at an early stage without any specific economic terms
proposed with respect to a potential transaction. Critical
Therapeutics board determined that the stage of
discussions with Cornerstone justified additional mutual due
diligence and the negotiation of definitive documentation
regarding a merger between the two companies.
On April 14, 2008, Critical Therapeutics board of
directors met by telephone conference. Mr. Kelly and
Scott B. Townsend, Senior Vice President of Legal Affairs,
General Counsel and Secretary of Critical Therapeutics,
participated in the meeting. Dr. Phillips and
Mr. Kelly provided the board with an update on the status
of discussions with Cornerstone regarding a potential
transaction, the status of a draft definitive merger agreement
with Cornerstone and the status of financial and accounting due
diligence on Cornerstone. Dr. Phillips then provided
Critical Therapeutics board with an update regarding the
status of discussions with other potential candidates for a
strategic transaction.
On April 15, 2008, Critical Therapeutics provided
Cornerstone with a first draft of a definitive merger agreement.
Between April 15, 2008 and April 30, 2008,
representatives of Critical Therapeutics and Cornerstone
negotiated the terms of the proposed merger agreement.
Negotiations focused on, among other matters, the conditions to
closing, post-signing operating covenants, termination rights,
the amount of
101
termination fees, required levels of cash, debt and working
capital, representations and warranties, and the timing of the
re-audit of Cornerstones financial statements.
On April 18, 2008, Dr. Phillips and Mr. Collard
met by telephone conference to discuss various aspects of the
proposed transaction, including operational and business
strategy issues.
On April 24, 2008, Critical Therapeutics board of
directors held a meeting by telephone conference. Also present
at this meeting were members of Critical Therapeutics
management and representatives of WilmerHale and Lazard. At this
meeting, among other things, Dr. Phillips provided an
update on and led a discussion regarding the potential
transaction with Cornerstone, including the status of financial,
tax and accounting due diligence, and the status of negotiations
regarding a draft definitive agreement with Cornerstone. After
discussion, the board determined to proceed with the final
negotiations of a definitive agreement with Cornerstone.
Following Critical Therapeutics board meeting on
April 24, 2008, representatives of Critical Therapeutics,
WilmerHale, Lazard, Cornerstone, Jefferies and Smith, Anderson,
Blount, Dorsett, Mitchell & Jernigan, L.L.P., or Smith
Anderson, Cornerstones outside legal counsel, continued
negotiation of the definitive agreement. Preliminary agreement
was reached on a number of matters, including agreement that the
exchange ratio in the merger would provide that Critical
Therapeutics stockholders would hold 30% of the combined
company but without a requirement that Critical Therapeutics
have a minimum amount of cash or working capital as a closing
condition and without any potential adjustment to the exchange
ratio based on Critical Therapeutics amount of cash or
working capital at closing. Later on April 24, 2008,
WilmerHale provided a revised draft of the merger agreement to
Cornerstone and its advisors reflecting these discussions and
the preliminary agreement of Critical Therapeutics and
Cornerstone.
On April 26, 2008, Critical Therapeutics board of
directors held a meeting by telephone conference to receive an
update on due diligence matters with respect to Cornerstone and
the strategic fit of Critical Therapeutics and Cornerstone.
Between April 25, 2008 and April 30, 2008, counsel for
Critical Therapeutics and Cornerstone had various communications
regarding the merger agreement and related acquisition
agreements and exchanged revised drafts of these agreements.
On April 28, 2008, members of Critical Therapeutics
management and WilmerHale met by telephone conference with
representatives of Cornerstone, including Mr. Collard, and
Smith Anderson to discuss the process for final approval and
execution of a definitive merger agreement, related disclosure
obligations under applicable securities laws and regulations and
a proposed communications plan and timeline.
On April 30, 2008, Critical Therapeutics board of
directors met to further consider the proposed merger of
Critical Therapeutics with Cornerstone and related matters. Also
participating in the meeting were members of Critical
Therapeutics management and representatives of WilmerHale
and Lazard. During that meeting:
|
|
|
|
|
Dr. Phillips provided a summary of Critical
Therapeutics process to date regarding consideration of a
proposed transaction with Cornerstone, including an overview of
the strategic alternatives process undertaken by the board
generally, discussions with Cornerstones management,
negotiations with respect to a proposed merger agreement and due
diligence conducted by Critical Therapeutics;
|
|
|
|
Dr. Phillips discussed with the board the strategic
business rationale for a combination with Cornerstone, including
with respect to the marketed products of, and product candidates
under development by, both Critical Therapeutics and Cornerstone
and the ability of the combined company to utilize
Cornerstones existing commercial organization;
|
|
|
|
Dr. Phillips presented his views on the competitive
environment facing Critical Therapeutics;
|
|
|
|
the board discussed Critical Therapeutics prospects as an
independent, standalone company;
|
|
|
|
Mr. Kelly reviewed with the board various financial
modeling scenarios, including models for Critical Therapeutics
as a standalone company, Cornerstone as a standalone company and
a combination of
|
102
|
|
|
|
|
Critical Therapeutics and Cornerstone, in each case utilizing
different assumptions regarding future business plans and
financing needs;
|
|
|
|
|
|
Mr. Heerman and Ms. Tucker discussed with the board
their due diligence review with respect to Cornerstones
historical and projected sales, its sales and marketing
organization and its regulatory affairs;
|
|
|
|
Lazard discussed with the board financial aspects of the
proposed merger, including, among other things, a summary of the
results of Critical Therapeutics strategic review process
and Lazards preliminary views with respect to the exchange
ratio provided for in the proposed merger in preparation for
Critical Therapeutics board meeting to be held on
May 1, 2008;
|
|
|
|
the WilmerHale representatives outlined the fiduciary duties and
responsibilities of the board under applicable law and
summarized the principal terms of the proposed merger agreement
and related acquisition agreements; and
|
|
|
|
the board discussed at length the proposed business combination
with Cornerstone, the appropriateness of the exchange ratio in
the proposed merger and the nature of the deal protections,
closing conditions, covenants and termination rights set forth
in the proposed merger agreement, the competitive environment
facing Critical Therapeutics and Critical Therapeutics
prospects as an independent, standalone company.
|
Critical Therapeutics board of directors then reconvened
on May 1, 2008 with members of Critical Therapeutics
management and representatives of Critical Therapeutics
legal and financial advisors. During that meeting:
|
|
|
|
|
Critical Therapeutics board of directors again engaged in
a discussion regarding the matters discussed at the
April 30, 2008 meeting relating to the proposed business
combination between Critical Therapeutics and Cornerstone;
|
|
|
|
Lazard reviewed with Critical Therapeutics board its
financial analysis of the exchange ratio provided for in the
merger and rendered to Critical Therapeutics board an oral
opinion, which opinion was confirmed by delivery of a written
opinion, dated May 1, 2008, to the effect that, as of that
date and based upon and subject to the assumptions, factors and
qualifications set forth in its opinion, the exchange ratio was
fair, from a financial point of view, to Critical
Therapeutics; and
|
|
|
|
Critical Therapeutics board further discussed and
deliberated at length the proposed business combination with
Cornerstone, the appropriateness of the exchange ratio in the
proposed merger and the nature of the deal protections, closing
conditions, covenants and termination rights set forth in the
proposed merger agreement, the competitive environment facing
Critical Therapeutics and Critical Therapeutics prospects
as an independent, standalone company.
|
Following this discussion and deliberation, Critical
Therapeutics board of directors unanimously determined
that the merger agreement and the transactions contemplated
thereby, including the merger, are advisable, fair to and in the
best interests of the stockholders of Critical Therapeutics,
unanimously approved the merger agreement and unanimously
recommended that the Critical Therapeutics stockholders
approve the issuance of Critical Therapeutics common stock
pursuant to the merger agreement, the reverse stock split of
Critical Therapeutics common stock and the name change of
Critical Therapeutics to Cornerstone Therapeutics
Inc.
Critical Therapeutics and Cornerstone executed the merger
agreement on May 1, 2008 after the close of trading on The
NASDAQ Global Market and made a joint public announcement of the
proposed transaction later that day.
Cornerstones
Background of the Merger
A key element of Cornerstones strategy to achieve its goal
of becoming a leading specialty pharmaceutical company is to
expand its product portfolio through the acquisition of rights
to FDA-approved respiratory pharmaceutical products with
well-established safety and efficacy profiles and projected
annual sales providing
103
attractive returns on investment. In furtherance of this
strategic element, Cornerstones management continually
monitors developments in other pharmaceutical companies with a
respiratory focus or respiratory products for acquisition
opportunities.
Following Critical Therapeutics public announcement on
November 8, 2007 that it was evaluating a range of
strategic alternatives, including the sale or divestiture of
certain assets, the merger or sale of the company or other
strategic transactions, Cornerstone management began reviewing
Critical Therapeutics filings with the SEC to assess
whether Critical Therapeutics or one of its products might be a
possible acquisition candidate for Cornerstone.
Between February 15, 2008 and March 3, 2008, Craig
Collard, President, Chief Executive Officer and a director of
Cornerstone, Alastair McEwan, Chairman of the board of directors
of Cornerstone, and Brian Dickson, M.D., Cornerstones
Chief Medical Officer, engaged in preliminary e-mail and
telephonic communications and exchanged non-public information
with management of Critical Therapeutics to learn about each
others respective companies and businesses and to
preliminarily determine whether a transaction between
Cornerstone and Critical Therapeutics might provide a good
strategic fit. On March 3, 2008, Mr. Collard
e-mailed
Frank E. Thomas, then President and Chief Executive Officer
of Critical Therapeutics, to inform him that Cornerstone was
interested in continuing discussions regarding a transaction
with Critical Therapeutics, and Mr. McEwan requested a
meeting with David Price, a managing director of Jefferies, to
solicit Jefferies assistance in connection with a possible
transaction with Critical Therapeutics. Thereafter, throughout
the negotiation process with Critical Therapeutics,
Mr. Collard and Mr. McEwan, both of whom are
Cornerstone employees and who comprised the entire board of
directors of Cornerstone throughout the period of negotiations,
served as the principal negotiators for the transaction on
behalf of Cornerstone. Because of this direct and personal
involvement in negotiating the terms and conditions of the
merger, Mr. Collard and Mr. McEwan, who were the only
directors of Cornerstone throughout the period, did not formally
convene as a board of directors to consider the potential terms
of a transaction and the acquisition process in general and
instead collaborated closely on the transaction on a daily basis
until they acted to formally approve the transaction on
May 1, 2008 through the adoption of board resolutions.
On March 5, 2008, Mr. Price traveled to
Cornerstones headquarters in Cary, North Carolina, to
discuss the engagement of Jefferies as exclusive financial
advisor to Cornerstone in connection with a possible transaction
with Critical Therapeutics. Mr. Collard and
Mr. McEwan, constituting all of the directors of
Cornerstone, agreed to tentatively engage Jefferies, and
Jefferies agreed to immediately commence providing advice and
assistance to Cornerstone, in each case, subject to the
execution of a mutually satisfactory engagement agreement.
Following the March 5, 2008 meeting until the execution of
the merger agreement, Mr. Collard and Mr. McEwan
received active and continual support from Mr. Price of
Jefferies, who accompanied Mr. Collard and Mr. McEwan
to each of their negotiating meetings with Critical
Therapeutics management.
On March 7, 2008, Mr. Collard, Dr. Dickson and
Mr. McEwan for Cornerstone, Critical Therapeutics senior
management, including Dr. Phillips, Mr. Thomas and
Mr. Kelly, and Jefferies representatives, including
Mr. Price, participated in meetings in Lexington,
Massachusetts during which Critical Therapeutics and Cornerstone
management teams made presentations regarding their respective
companies and their businesses. Following these meetings, during
the period from March 7 to March 17, 2008, each company engaged
in extensive due diligence on the business, assets and
liabilities of the other company, and representatives of both
companies management teams and their respective legal and
financial advisors conducted numerous discussions regarding the
potential terms of a transaction and the acquisition process in
general.
On March 17, 2008, Cornerstone sent a letter via
e-mail to
Critical Therapeutics reflecting a non-binding expression of
interest regarding a potential merger with Critical Therapeutics
in which Critical Therapeutics would issue common stock to
Cornerstone stockholders for all of Cornerstones equity
capital. In this letter, Cornerstone preliminarily proposed a
transaction in which Critical Therapeutics stockholders
would hold 34% of the combined company, based on Critical
Therapeutics having a cash balance at closing of at least
$20 million.
On March 19, 2008, Jefferies provided to Mr. Collard
and Mr. McEwan its perspectives regarding negotiating
tactics with respect to a potential transaction with Critical
Therapeutics. Following a presentation by
104
representatives of Cornerstone on March 20, 2008 to
Critical Therapeutics board regarding a possible strategic
transaction between Cornerstone and Critical Therapeutics and
related matters, on March 21, 2008, Critical Therapeutics
sent a letter via
e-mail to
Cornerstone with a response to Cornerstones expression of
interest regarding potential terms of a transaction. In this
letter, Critical Therapeutics preliminarily proposed a
transaction in which Critical Therapeutics stockholders
would hold 35% of the combined company.
On March 25, 2008, Jefferies, on behalf of Cornerstone,
sent a letter via
e-mail in
response to Critical Therapeutics letter of March 21,
2008. In that letter, Cornerstone preliminarily proposed a
transaction in which Critical Therapeutics stockholders
would hold 31% of the combined company, based on a projected
cash balance at closing for Critical Therapeutics of
$12 million.
Also on March 25, 2008, Critical Therapeutics, Cornerstone
and their respective financial advisors held a telephone
conference to discuss financial projections for each company,
including as described in the section of this proxy
statement/prospectus entitled Financial Projections,
and the possible impact that such projections for each company
could have with respect to the combined company.
On March 28, 2008, Cornerstone and Jefferies entered into a
written agreement confirming Cornerstones engagement of
Jefferies as exclusive financial advisor to Cornerstone in
connection with a possible transaction with Critical
Therapeutics.
Also on March 28, 2008, Cornerstone sent a letter to
Critical Therapeutics clarifying particular items regarding
potential deal terms, including proposing an exclusivity period
and proposing that the proportion of the combined company that
Critical Therapeutics stockholders would hold would be
variable based on Critical Therapeutics cash balance at
closing.
On April 8 and 9, 2008, representatives of Cornerstone and
Critical Therapeutics and representatives of Jefferies and
Lazard discussed further financial projections for each company,
including as described in the section of this proxy
statement/prospectus entitled Financial Projections,
and the possible impact that such projections for each company
could have with respect to the combined company.
Following a second presentation by representatives of
Cornerstone on April 10, 2008 to Critical
Therapeutics board regarding a possible strategic
transaction between Cornerstone and Critical Therapeutics and
related matters, on April 15, 2008, Critical Therapeutics
provided Cornerstone with a first draft of a definitive merger
agreement. Between April 15, 2008 and April 30, 2008,
representatives of Critical Therapeutics and Cornerstone
negotiated the terms of the proposed merger agreement.
Negotiations focused on, among other matters, the conditions to
closing, post-signing operating covenants, termination rights,
the amount of termination fees, required levels of cash, debt
and working capital, representations and warranties, and the
timing of the re-audit of Cornerstones financial
statements.
On April 24, 2008, Cornerstone representatives, including
Mr. Collard, Mr. McEwan and Dr. Dickson, met in
New York, New York with representatives of Critical
Therapeutics, WilmerHale, Lazard, Jefferies and Smith Anderson,
Cornerstones outside legal counsel, and continued
negotiation of the definitive agreement. Preliminary agreement
was reached on a number of matters, including agreement that the
exchange ratio in the merger would provide that Critical
Therapeutics stockholders would hold 30% of the combined
company but without a requirement that Critical Therapeutics
have a minimum amount of cash or working capital as a closing
condition and without any potential adjustment to the exchange
ratio based on Critical Therapeutics amount of cash or
working capital at closing.
Between April 24, 2008 and April 30, 2008, counsel for
Critical Therapeutics and Cornerstone had various communications
regarding the merger agreement and related acquisition
agreements and exchanged revised drafts of these agreements.
Throughout this period, Smith Anderson was in frequent
communication with Mr. Collard and Mr. McEwan
regarding finalizing the terms and conditions of the merger
agreement.
On April 28, 2008, members of Critical Therapeutics
management and WilmerHale met by telephone conference with
representatives of Cornerstone, including Mr. Collard, and
Smith Anderson to discuss the process for final approval and
execution of a definitive merger agreement, related disclosure
obligations under applicable securities laws and regulations and
a proposed communications plan and timeline.
105
Following discussions with Jefferies and Smith Anderson
representatives and Cornerstone management, Mr. Collard and
Mr. McEwan engaged in extensive discussion and deliberation
regarding the proposed business combination with Critical
Therapeutics, the appropriateness of the exchange ratio in the
proposed merger and the nature of the deal protections, closing
conditions, covenants and termination rights set forth in the
proposed merger agreement, the prospects for increasing ZYFLO CR
net revenues taking into account sales force efficiencies to be
achieved by promoting ZYFLO CR alongside Cornerstones
other products during calls on prescribers and prospects of the
combined company.
On May 1, 2008, Cornerstones board of directors,
unanimously determined that the merger agreement and the
transactions contemplated thereby, including the merger, are
advisable, fair to and in the best interests of the stockholders
of Cornerstone, and unanimously approved the merger agreement
and the other transactions contemplated by the merger agreement,
and unanimously recommended that Cornerstones stockholders
approve the merger with Critical Therapeutics.
Critical Therapeutics and Cornerstone executed the merger
agreement on May 1, 2008 after the close of trading on The
NASDAQ Global Market and made a joint public announcement of the
proposed transaction later that day. Contemporaneously with
Cornerstones execution of the merger agreement,
Cornerstone and Carolina Pharmaceuticals, which is the holder of
the Carolina Note, entered into an agreement that provides,
among other things, for the exchange or conversion of the
outstanding principal amount of the Carolina Note into shares of
Cornerstones common stock prior to the effective time of
the merger.
On May 2, 2008, holders of a majority of the shares of
Cornerstones outstanding common stock acting by written
consent without a meeting in accordance with Section 228 of
the Delaware General Corporation Law and Cornerstones
bylaws approved the merger agreement and the transactions
contemplated thereby.
Financial
Projections
During the course of the mutual due diligence review process
undertaken in connection with the proposed merger, Critical
Therapeutics and Cornerstone each made available to the other
party non-public business and financial information about their
companies, including financial projections.
The projections provided by Critical Therapeutics included the
following estimates of Critical Therapeutics future
financial performance as an independent, standalone company.
|
|
|
|
|
|
|
|
|
|
|
Projected for Critical Therapeutics
|
|
|
|
2008
|
|
|
2009
|
|
|
|
(Unaudited, amounts in thousands)
|
|
|
Total Revenues
|
|
$
|
19,194
|
|
|
$
|
27,857
|
|
Operating Loss
|
|
|
(21,477
|
)
|
|
|
(12,941
|
)
|
Net Loss
|
|
|
(21,114
|
)
|
|
|
(12,922
|
)
|
The projections in the table above assumed, among other things,
that Critical Therapeutics would not reduce its workforce, that
a sufficient supply of ZYFLO CR would remain available for sale
and that there would be no significant alterations or
terminations of material contractual relationships.
The projections provided by Cornerstone included the following
estimates of Cornerstones future financial performance as
an independent, standalone company.
|
|
|
|
|
|
|
|
|
|
|
Projected for Cornerstone
|
|
|
|
2008
|
|
|
2009
|
|
|
|
(Unaudited, amounts in thousands)
|
|
|
Total Revenues
|
|
$
|
48,957
|
|
|
$
|
92,953
|
|
Operating Income
|
|
|
7,880
|
|
|
|
21,763
|
|
Net Income
|
|
|
4,127
|
|
|
|
12,524
|
|
The projections in the table above assumed, among other things,
that clinical development and regulatory milestones with respect
to Cornerstones product candidates would be achieved at
costs and on timetables substantially consistent with
managements expectations, that a sufficient supply of all
of Cornerstones
106
currently marketed products and products targeted for launch
during 2008 or 2009 would remain available for sale and that
Cornerstone would experience no significant alterations or
terminations of material contractual relationships. As part of
its evaluation of the transaction and Cornerstones
projected financial performance, Critical Therapeutics
board of directors also considered the potential impact of
changes to, among other things, the achievement by Cornerstone
of clinical development and regulatory milestones at costs and
on timetables substantially consistent with managements
expectations and Cornerstones ability to achieve its
revenue forecasts for its existing products.
The non-public business and financial information and
projections that Critical Therapeutics and Cornerstone provided
to each other during the course of the mutual due diligence
review process were provided solely in connection with such due
diligence review and not expressly for inclusion or
incorporation by reference in any filing with the SEC or
document to be provided to stockholders of either company. The
estimates of future financial performance for Critical
Therapeutics and Cornerstone described above also were provided
to Lazard for use in its financial analysis in connection with
its opinion. There is no guarantee that any projections will be
realized, or that the assumptions on which they are based will
prove to be correct.
Critical Therapeutics does not as a matter of course make public
any projections as to future performance or earnings, other than
limited guidance for periods no longer than one year. As a
private company, Cornerstone has not previously made available
to the public any projections as to its future financial
performance. The projections set forth above are included in
this proxy statement/prospectus only because this information
was provided to the other party. The projections were not
prepared with a view to public disclosure or compliance with the
published guidelines of the SEC or the guidelines established by
the American Institute of Certified Public Accountants regarding
projections or forecasts. The projections do not purport to
present operations in accordance with GAAP.
Neither Critical Therapeutics nor Cornerstones
independent auditors, nor any other independent accountants,
have compiled, examined or performed any procedures with respect
to the prospective financial information contained herein, nor
have they expressed any opinion or any other form of assurance
on such information or its achievability, and assume no
responsibility for, and disclaim any association with, the
prospective financial information.
Each companys internal financial forecasts, upon which the
projections were based in part, are, in general, prepared solely
for internal use, such as budgeting and other management
decisions, and are subjective in many respects. As a result,
these internal financial forecasts are susceptible to
interpretations and periodic revision based on actual experience
and business developments. The projections reflect numerous
assumptions made by the management of Critical Therapeutics and
Cornerstone, as applicable, and general business, economic,
market and financial conditions and other matters, all of which
are difficult to predict and many of which are beyond the
companys control. Accordingly, there can be no assurance
that the assumptions made in preparing the projections will
prove accurate or that any of the projections will be realized.
Differences between actual and projected results are to be
expected, and actual results may be materially greater or less
than those contained in the projections due to numerous risks
and uncertainties, including but not limited to the important
factors listed in the section of this proxy statement/prospectus
entitled Risk Factors. All projections are
forward-looking statements, and these and other forward-looking
statements are expressly qualified in their entirety by the
risks and uncertainties identified in the Risk
Factors section.
The inclusion of the projections herein should not be regarded
as an indication that any of Critical Therapeutics, Cornerstone,
Lazard or their respective affiliates or representatives
considered or consider the projections to be a prediction of
actual future events, and the projections should not be relied
upon as such. Except as may be required by law, none of Critical
Therapeutics, Cornerstone, or any of their respective affiliates
or representatives intends to update or otherwise revise the
projections to reflect circumstances existing or arising after
the date such projections were generated or to reflect the
occurrence of future events, even in the event that any or all
of the assumptions underlying the projections are shown to be in
error.
Stockholders are cautioned not to place undue reliance on the
projections included in this proxy statement/prospectus.
107
Reasons
for the Merger
Mutual
Reasons for the Merger
Critical Therapeutics and Cornerstone believe that the combined
company resulting from the merger will have the following
potential advantages:
|
|
|
|
|
The combined company will be a larger respiratory-focused
specialty pharmaceutical company with multiple approved
products, a more balanced revenue stream and important product
development opportunities.
|
|
|
|
The combined company is expected to focus its resources on
developing a successful specialty pharmaceutical business
without the additional challenge of trying to simultaneously
build an early-stage drug development pipeline.
|
|
|
|
There are significant potential synergies and cost savings that
Critical Therapeutics and Cornerstone believe can be achieved by
consolidating the infrastructures of the two companies and
allowing management to fully leverage the combined sales force
across multiple revenue generating products.
|
Critical
Therapeutics Reasons for the Merger
In evaluating the merger, Critical Therapeutics board of
directors consulted with senior management and Critical
Therapeutics legal and financial advisors, and, in the
course of reaching its determination to approve the merger
agreement, Critical Therapeutics board of directors
considered a number of factors, including the following:
|
|
|
|
|
historical and current information concerning Critical
Therapeutics business, including negative trends in its
financial performance, financial condition, operations and
competitive position;
|
|
|
|
current financial market conditions, and historical market
prices, volatility and trading information with respect to
Critical Therapeutics common stock;
|
|
|
|
Critical Therapeutics limited prospects if it were to
remain an independent, standalone company as a result of factors
such as slower than anticipated sales of ZYFLO CR, ongoing
supply chain issues relating to ZYFLO CR, Critical
Therapeutics declining cash balance, the expenses and
fixed costs associated with its operations and prospects for
development and commercialization of additional products,
particularly given Critical Therapeutics limited resources;
|
|
|
|
substantial doubt regarding the ability of Critical Therapeutics
to continue as a going concern without obtaining additional
financing and the view of Critical Therapeutics board of
directors regarding Critical Therapeutics ability to
secure additional financing as an independent, standalone
company;
|
|
|
|
historical and current information concerning Cornerstones
business, financial performance, financial condition, operations
and management, including the results of a due diligence
investigation of Cornerstone conducted by Critical
Therapeutics management and advisors;
|
|
|
|
the view that the combination with Cornerstone would result in a
combined company with the potential for enhanced future growth
and value as compared to Critical Therapeutics as an
independent, standalone company;
|
|
|
|
the opportunity for Critical Therapeutics stockholders to
participate in the potential future value of the combined
company;
|
|
|
|
Critical Therapeutics board of directors view as to
the potential for other third parties to enter into strategic
relationships with or acquire Critical Therapeutics on favorable
terms, if at all, based on the lack of interest expressed by
third parties during the strategic alternatives review process
undertaken by Critical Therapeutics;
|
|
|
|
the belief that the merger was more favorable to Critical
Therapeutics stockholders than any other alternative
reasonably available to Critical Therapeutics and its
stockholders, including the alternative of remaining an
independent, standalone company;
|
108
|
|
|
|
|
the opinion of Lazard, dated May 1, 2008, to Critical
Therapeutics board of directors as to the fairness, from a
financial point of view and as of the date of the opinion, to
Critical Therapeutics of the exchange ratio provided for in the
merger, as more fully described below under the caption
Opinion of Critical Therapeutics Financial
Advisor; and
|
|
|
|
the terms and conditions of the merger agreement, including:
|
|
|
|
|
|
the determination that the relative percentage ownership of the
combined company by Critical Therapeutics stockholders and
Cornerstones stockholders is consistent with Critical
Therapeutics perceived valuations of each company at the
time Critical Therapeutics board of directors approved the
merger agreement;
|
|
|
|
the non-solicitation provisions limiting Cornerstones
ability to engage in discussions or negotiations regarding, or
furnish to any person any information with respect to, assist or
participate in any effort or attempt by any person with respect
to, or otherwise cooperate in any way with, an alternative
acquisition proposal;
|
|
|
|
Critical Therapeutics rights under the merger agreement to
pursue alternative acquisition proposals received independently
under specified circumstances;
|
|
|
|
the conditions to the closing of the merger and the likelihood
of their being satisfied, including the requirement that
Cornerstones stockholders adopt the merger agreement by
written consents in lieu of a meeting promptly following the
signing of the merger agreement;
|
|
|
|
the absence of any condition to the closing of the merger
requiring Critical Therapeutics to have a minimum amount of cash
or working capital at closing and the absence of any terms
providing for an adjustment to the exchange ratio based on the
amount of cash or working capital at closing for Critical
Therapeutics;
|
|
|
|
the requirement that holders of a majority of the shares of
Cornerstones outstanding common stock enter into
agreements providing that the stockholders vote in favor of
adoption of the merger agreement and against any proposal made
in opposition to, or in any competition with, the merger;
|
|
|
|
Critical Therapeutics board of directors belief that
the $1.0 million termination fee payable to Cornerstone in
the circumstances set forth in the merger agreement was
reasonable in the context of termination fees that were payable
in other comparable transactions and would not be likely to
preclude another party from making a superior acquisition
proposal; and
|
|
|
|
the qualification of the merger as a reorganization for
U.S. federal income tax purposes, with the result that in
the merger neither Critical Therapeutics nor
Cornerstones stockholders will recognize gain or loss for
U.S. federal income tax purposes.
|
In the course of its deliberations, Critical Therapeutics
board of directors also considered a variety of risks and other
countervailing factors related to entering into the merger
agreement, including the following:
|
|
|
|
|
the risk that the merger might not be completed in a timely
manner or at all due to failure to satisfy the closing
conditions, some of which are outside of Critical
Therapeutics control;
|
|
|
|
if the merger is not completed, the potential adverse effect of
the public announcement of the merger on Critical
Therapeutics business, including its significant supplier,
distributor and other key business relationships, Critical
Therapeutics ability to attract and retain key personnel
and Critical Therapeutics overall competitive position;
|
|
|
|
the immediate and substantial dilution of the equity interests
and voting power of Critical Therapeutics stockholders
upon completion of the merger;
|
|
|
|
the ability of Cornerstones current stockholders to
significantly influence the combined companys business
after the completion of the merger;
|
109
|
|
|
|
|
the risk that the combined company may be unable to raise needed
additional capital in the near term and that such additional
capital, even if available, will be further dilutive to Critical
Therapeutics stockholders and may be at a lower valuation
than reflected in the merger;
|
|
|
|
the restrictions that the merger agreement imposes on soliciting
competing acquisition proposals;
|
|
|
|
the fact that Critical Therapeutics would be obligated to pay
the $1.0 million termination fee to Cornerstone if the
merger agreement is terminated under the following circumstances:
|
|
|
|
|
|
by Cornerstone because the merger has not occurred by
November 30, 2008 due to the failure of Critical
Therapeutics to satisfy closing conditions relating to approval
by Critical Therapeutics stockholders of the proposals to
be presented at the special meeting, the fulfillment of Critical
Therapeutics obligations under the merger agreement or
delivery of the stockholder agreements entered into with
Critical Therapeutics stockholders;
|
|
|
|
by Cornerstone or Critical Therapeutics because Critical
Therapeutics stockholders fail to approve the proposals
presented at the special meeting if at or prior to the time of
such failure an acquisition proposal relating to Critical
Therapeutics was announced and was not abandoned or withdrawn;
|
|
|
|
by Cornerstone because (i) Critical Therapeutics
board of directors fails to make, withdraws or modifies its
recommendation that Critical Therapeutics stockholders
vote for the proposals presented at the special meeting,
(ii) after the receipt by Critical Therapeutics of an
acquisition proposal, Critical Therapeutics board of
directors fails to reconfirm its recommendation of the merger
agreement or the merger, (iii) Critical Therapeutics
board of directors approves or recommends any acquisition
proposal, (iv) a tender or exchange offer for Critical
Therapeutics common stock is commenced (other than by
Cornerstone or its affiliates) and Critical Therapeutics
board of directors recommends that Critical Therapeutics
stockholders tender their shares in such offer or fails to
recommend against acceptance of such offer, (v) Critical
Therapeutics breaches its non-solicitation obligations or
stockholder covenants or (vi) Critical Therapeutics fails
to hold the special meeting by November 28, 2008; or
|
|
|
|
by Cornerstone because there has been a breach of or failure to
perform any representation, warranty, covenant or agreement by
Critical Therapeutics that would cause conditions to the closing
of the merger not to be satisfied, and such failure or breach is
not cured within 30 days after receipt of written notice
from Cornerstone, provided that such 30 day period may not
extend beyond November 26, 2008;
|
|
|
|
|
|
Critical Therapeutics inability to terminate the merger
agreement if it accepts or recommends a superior acquisition
proposal;
|
|
|
|
the restrictions on the conduct of Critical Therapeutics
business prior to the completion of the merger, which require
Critical Therapeutics to carry on its business in the usual,
regular and ordinary course in substantially the same manner as
previously conducted, subject to specific additional
restrictions, which may delay or prevent Critical Therapeutics
from pursuing business opportunities that would otherwise be in
its best interests as a standalone company;
|
|
|
|
the requirement that Critical Therapeutics receive approval from
NASDAQ for the re-listing of Critical Therapeutics common
stock in connection with the merger based on NASDAQs
initial listing requirements;
|
|
|
|
the challenges and costs of combining administrative operations
and the substantial expenses to be incurred in connection with
the merger, including the risks that delays or difficulties in
completing the administrative integration and such other
expenses, as well as the additional public company expenses and
obligations that Cornerstone will be subject to in connection
with the merger that it has not previously been subject to,
could adversely affect the combined companys operating
results and preclude the achievement of some benefits
anticipated from the merger;
|
110
|
|
|
|
|
the possible volatility, at least in the short term, of the
trading price of Critical Therapeutics common stock
resulting from the announcement and pendency of the merger;
|
|
|
|
the possible earlier than anticipated loss of key management or
other personnel of Critical Therapeutics;
|
|
|
|
the risk of diverting managements attention from
day-to-day operations to implement the merger;
|
|
|
|
the interests of Critical Therapeutics executive officers
and directors in the transactions contemplated by the merger
agreement, as described in the section of this proxy
statement/prospectus entitled Interests of Critical
Therapeutics Directors and Executive Officers in the
Merger; and
|
|
|
|
various other applicable risks associated with the business of
Cornerstone and the combined company and the merger, including
those described in the section of this proxy
statement/prospectus entitled Risk Factors.
|
The foregoing discussion of the factors considered by Critical
Therapeutics board of directors is not intended to be
exhaustive, but does set forth the principal factors considered
by Critical Therapeutics board of directors. Critical
Therapeutics board of directors collectively reached the
unanimous conclusion to approve the merger agreement in light of
the various factors described above and other factors that each
member of Critical Therapeutics board of directors deemed
relevant. In view of the wide variety of factors considered by
the members of Critical Therapeutics board of directors in
connection with their evaluation of the merger agreement and the
complexity of these matters, Critical Therapeutics board
of directors did not consider it practical, and did not attempt,
to quantify, rank or otherwise assign relative weights to the
specific factors it considered in reaching its decision.
Critical Therapeutics board of directors made its decision
based on the totality of information presented to and considered
by it. In considering the factors discussed above, individual
directors may have given different weights to different factors.
Critical Therapeutics board of directors unanimously
determined that the merger agreement and the merger are
advisable, fair to and in the best interests of Critical
Therapeutics stockholders and unanimously approved the
merger agreement. Critical Therapeutics board of
directors unanimously recommends that Critical
Therapeutics stockholders approve the issuance of Critical
Therapeutics common stock pursuant to the merger
agreement, the reverse stock split and the change of Critical
Therapeutics name to Cornerstone Therapeutics
Inc.
Cornerstones
Reasons for the Merger
In evaluating the merger, Cornerstones board of directors
consulted with senior management and Cornerstones legal
and financial advisors, and, in the course of reaching its
determination to approve the merger agreement,
Cornerstones board of directors considered a number of
factors, including the following:
|
|
|
|
|
historical and current information concerning Cornerstones
business, financial performance, financial condition, operations
and management;
|
|
|
|
the view that the combination with Critical Therapeutics would
result in a combined company with the potential for enhanced
future growth and value as compared to Cornerstone as an
independent, standalone company;
|
|
|
|
the likely greater range of options available to the combined
company to access private and public equity markets should
additional capital be needed in the future than the range of
options available to Cornerstone as a private company;
|
|
|
|
the opportunity to expand Cornerstones respiratory product
portfolio with ZYFLO CR;
|
|
|
|
the possibility of other strategic alternatives to the merger
for enhancing long-term stockholder value, including
investigating strategic transactions with other companies;
|
|
|
|
the possibility of other alternatives to expand
Cornerstones product portfolio through the acquisition of
rights to FDA-approved respiratory products through asset
purchase or licensing transactions not involving a strategic
combination with another company;
|
111
|
|
|
|
|
the terms and conditions of the merger agreement, including:
|
|
|
|
|
|
the determination that the relative percentage ownership of the
combined company by Critical Therapeutics stockholders and
Cornerstones stockholders is consistent with
Cornerstones perceived valuations of each company at the
time Cornerstones board of directors approved the merger
agreement;
|
|
|
|
the non-solicitation provisions limiting both Cornerstones
and Critical Therapeutics ability to engage in discussions
or negotiations regarding, or furnish to any person any
information with respect to, assist or participate in any effort
or attempt by any person with respect to, or otherwise cooperate
in any way with, an alternative acquisition proposal;
|
|
|
|
the conditions to the closing of the merger and the likelihood
of their being satisfied, including the fact that stockholders
that own in the aggregate approximately 19% of Critical
Therapeutics outstanding common stock will have entered
into agreements with Cornerstone that provide, among other
things, that the stockholders will vote in favor of the issuance
of shares of Critical Therapeutics common stock in the
merger;
|
|
|
|
the requirement that holders of a majority of the shares of
Cornerstones outstanding common stock enter into
agreements providing that the stockholders vote in favor of
adoption of the merger agreement and against any proposal made
in opposition to, or in any competition with, the merger;
|
|
|
|
the requirement that the principal amount outstanding under the
Carolina Note be exchanged for shares of Cornerstone common
stock immediately prior to the consummation of the merger such
that the resulting dilution would be suffered solely by
Cornerstones current stockholders and not by Critical
Therapeutics current stockholders; and
|
|
|
|
the qualification of the merger as a reorganization for
U.S. federal income tax purposes, with the result that in
the merger neither Critical Therapeutics nor
Cornerstones stockholders will recognize gain or loss for
U.S. federal income tax purposes.
|
In the course of its deliberations, Cornerstones board of
directors also considered a variety of risks and other
countervailing factors related to entering into the merger
agreement, including the following:
|
|
|
|
|
negative trends in Critical Therapeutics financial
performance, financial condition, operations and competitive
position;
|
|
|
|
current financial market conditions, and historical market
prices, volatility and trading information with respect to
Critical Therapeutics common stock;
|
|
|
|
slower than anticipated sales of ZYFLO CR, ongoing supply chain
issues relating to ZYFLO CR, Critical Therapeutics
declining cash balance and the expenses and fixed costs
associated with Critical Therapeutics operations and
prospects for internal development and commercialization of
additional products by Critical Therapeutics;
|
|
|
|
the risk that the merger might not be completed in a timely
manner or at all due to failure to satisfy the closing
conditions, some of which are outside of Cornerstones
control, and the potential adverse effect of the public
announcement of the merger on Cornerstones reputation and
ability to obtain financing in the future in the event the
merger is not completed;
|
|
|
|
the immediate and substantial dilution of the equity interests
and voting power of Cornerstones stockholders upon
completion of the merger;
|
|
|
|
the risk that the combined company may be unable to raise needed
additional capital in the near term and that such additional
capital, even if available, will be further dilutive to
Cornerstones stockholders and may be at a lower valuation
than reflected in the merger;
|
|
|
|
the restrictions that the merger agreement imposes on soliciting
competing acquisition proposals or pursuing alternative
respiratory product acquisition opportunities that may come to
Cornerstones attention prior to completion of the merger;
|
112
|
|
|
|
|
the restrictions on the conduct of Cornerstones business
prior to the completion of the merger, which require Cornerstone
to carry on its business in the usual, regular and ordinary
course in substantially the same manner as previously conducted,
subject to specific additional restrictions, which may delay or
prevent Cornerstone from pursuing business opportunities that
would otherwise be in its best interests as a standalone company;
|
|
|
|
the risk that Critical Therapeutics might not receive approval
from NASDAQ for re-listing of Critical Therapeutics common
stock in connection with the merger based on NASDAQs
initial listing requirements;
|
|
|
|
the challenges and costs of combining administrative operations
and the substantial expenses to be incurred in connection with
the merger, including the risks that delays or difficulties in
completing the administrative integration and such other
expenses, as well as the additional public company expenses and
obligations that Cornerstone will be subject to in connection
with the merger that it has not previously been subject to,
could adversely affect the combined companys operating
results and preclude the achievement of some benefits
anticipated from the merger;
|
|
|
|
the possible volatility, at least in the short term, of the
trading price of Critical Therapeutics common stock
resulting from the announcement and pendency of the merger;
|
|
|
|
the possible earlier than anticipated loss of key management or
other personnel of Critical Therapeutics;
|
|
|
|
the risk of diverting managements attention from
day-to-day
operations to implement the merger;
|
|
|
|
the interests of Cornerstones executive officers and
directors in the transactions contemplated by the merger
agreement, as described in the section of this proxy
statement/prospectus entitled Interests of
Cornerstones Directors and Executive Officers in the
Merger; and
|
|
|
|
various other applicable risks associated with the business of
Cornerstone and the combined company and the merger, including
those described in the section of this proxy
statement/prospectus entitled Risk Factors.
|
The foregoing discussion of the factors considered by
Cornerstones board of directors is not intended to be
exhaustive, but does set forth the principal factors considered
by Cornerstones board of directors. Cornerstones
board of directors collectively reached the unanimous conclusion
to approve the merger agreement in light of the various factors
described above and other factors that each member of
Cornerstones board of directors deemed relevant. In view
of the wide variety of factors considered by the members of
Cornerstones board of directors in connection with its
evaluation of the merger agreement and the complexity of these
matters, Cornerstones board of directors did not consider
it practical, and did not attempt, to quantify, rank or
otherwise assign relative weights to the specific factors it
considered in reaching its decision. Cornerstones board of
directors made its decision based on the totality of information
presented to and considered by it. In considering the factors
discussed above, individual directors may have given different
weights to different factors. The Cornerstone board of directors
conducted an overall analysis of the factors described above,
including thorough discussions with, and questioning of,
Cornerstones management and Cornerstones legal and
financial advisors, and considered the factors overall to be
favorable to, and to support, its determination.
Opinion
of Critical Therapeutics Financial Advisor
Lazard is acting as financial advisor to Critical Therapeutics
in connection with the merger. As part of that engagement,
Critical Therapeutics board of directors requested that
Lazard evaluate the fairness, from a financial point of view, to
Critical Therapeutics of the exchange ratio provided for in the
merger. At a meeting of Critical Therapeutics board of
directors held on May 1, 2008 to evaluate the merger,
Lazard delivered to Critical Therapeutics board of
directors an oral opinion, which opinion was confirmed by
delivery of a written opinion, dated May 1, 2008, to the
effect that, as of that date and based upon and subject to
certain
113
assumptions, factors and qualifications, the exchange ratio was
fair, from a financial point of view, to Critical Therapeutics.
The full text of Lazards opinion, which sets forth,
among other things, the procedures followed, assumptions made,
matters considered and qualifications and limitations on the
review undertaken by Lazard in connection with its opinion, is
attached to this proxy statement/prospectus as Annex D
and is incorporated into this proxy statement/prospectus by
reference. The material aspects of Lazards opinion are
summarized below. Lazards opinion was addressed to
Critical Therapeutics board of directors, was only one of
many factors considered by Critical Therapeutics board of
directors in its evaluation of the merger and only addresses the
fairness of the exchange ratio from a financial point of view to
Critical Therapeutics. Lazards opinion does not address
the merits of the underlying decision by Critical Therapeutics
to engage in the merger or related transactions or the relative
merits of the merger or related transactions as compared to any
other transaction or business strategy in which Critical
Therapeutics might engage, and is not intended to, and does not,
constitute a recommendation to any stockholder as to how such
stockholder should vote or act with respect to the merger or any
matter relating to the merger. Lazards opinion was
necessarily based on economic, monetary, market and other
conditions as in effect on, and the information made available
to Lazard as of, May 1, 2008, the date of its opinion.
Lazard assumes no responsibility for updating or revising its
opinion based on circumstances or events occurring after the
date of the opinion.
In connection with its opinion, Lazard:
|
|
|
|
|
reviewed the financial terms and conditions of the merger
agreement;
|
|
|
|
analyzed certain publicly available historical business and
financial information relating to Critical Therapeutics and
certain historical business and financial information relating
to Cornerstone;
|
|
|
|
reviewed various financial forecasts and other data provided to
Lazard by Critical Therapeutics relating to Critical
Therapeutics business and financial forecasts and other
data provided to Lazard by Cornerstone, as adjusted by Critical
Therapeutics, relating to Cornerstones business;
|
|
|
|
held discussions with members of the senior managements of
Critical Therapeutics and Cornerstone with respect to the
businesses and prospects of Critical Therapeutics and
Cornerstone, respectively;
|
|
|
|
reviewed public information with respect to certain other
companies in lines of business Lazard believed to be generally
relevant in evaluating the businesses of Critical Therapeutics
and Cornerstone, respectively;
|
|
|
|
reviewed historical stock prices and trading volumes of Critical
Therapeutics common stock; and
|
|
|
|
conducted such other financial studies, analyses and
investigations as Lazard deemed appropriate.
|
Lazard assumed and relied upon the accuracy and completeness of
the foregoing information, without independent verification of
such information. Lazard did not conduct any independent
valuation or appraisal of any of the assets or liabilities
(contingent or otherwise) of Critical Therapeutics or
Cornerstone or concerning the solvency or fair value of Critical
Therapeutics or Cornerstone, and Lazard was not furnished with
such valuation or appraisal. With respect to the financial
forecasts that Lazard reviewed (including, in the case of
Cornerstone, adjustments to such forecasts by Critical
Therapeutics), Lazard assumed, with Critical Therapeutics
consent, that they were reasonably prepared on bases reflecting
the best currently available estimates and judgments of the
managements of Critical Therapeutics and Cornerstone, as the
case may be, as to the future financial performance of Critical
Therapeutics and Cornerstone. Lazard assumed no responsibility
for and expressed no view as to such forecasts or the
assumptions on which they were based. Lazard relied on the
assessments of Critical Therapeutics management as to the
validity of, and risks associated with, the products and product
candidates of Critical Therapeutics and Cornerstone (including,
without limitation, the timing and probability of successful
development, testing and marketing, and of approval by
appropriate governmental authorities, of such products and
product candidates). Lazard was advised by representatives of
Critical Therapeutics and Cornerstone that a new audit of the
historical financial statements of Cornerstone would be
performed, and Lazard assumed, with Critical Therapeutics
consent, that such audited historical
114
financial statements, when completed, would not vary materially
from the audited historical financial statements of Cornerstone
provided to Lazard by Cornerstone.
In rendering its opinion, Lazard assumed, with Critical
Therapeutics consent, that the merger and related
transactions (including, without limitation, the reverse stock
split and the contemplated exchange or conversion of the
Carolina Note into shares of Cornerstone common stock as a
condition to the closing of the merger) would be consummated on
the terms described in the merger agreement, without any waiver
or modification of any material terms or conditions. Lazard also
assumed, with Critical Therapeutics consent, that
obtaining the necessary regulatory or third party approvals and
consents for the merger or any related transaction would not
have an adverse effect on Critical Therapeutics, Cornerstone or
the merger. Lazard further assumed, with Critical
Therapeutics consent, that the representations and
warranties of Critical Therapeutics and Cornerstone contained in
the merger agreement were true and complete and that the merger
would qualify for U.S. federal income tax purposes as a
reorganization within the meaning of Section 368(a) of the
Code. Lazard did not express any opinion as to any tax or other
consequences that might result from the merger or any related
transaction, nor did Lazards opinion address any legal,
tax, regulatory or accounting matters, as to which Lazard
understood that Critical Therapeutics obtained such advice as it
deemed necessary from qualified professionals. Lazard expressed
no view or opinion as to any terms or other aspects or
implications of the merger (other than the exchange ratio to the
extent expressly specified in its opinion) or any related
transaction, including, without limitation, the form or
structure of the merger, any adjustment to the exchange ratio
resulting from the reverse stock split, any other aspect or
implication of the reverse stock split or any agreements or
arrangements entered into in connection with, or otherwise
contemplated by, the merger. In addition, Lazard expressed no
view or opinion as to the fairness of the amount or nature of,
or any other aspects relating to, the compensation to any
officers, directors or employees of any parties to the merger,
or class of such persons, relative to the exchange ratio or
otherwise. Further, Lazard did not express any opinion as to the
price at which shares of Critical Therapeutics common
stock would trade at any time subsequent to the announcement of
the merger. Except as described above, Critical Therapeutics
imposed no other instructions or limitations on Lazard with
respect to the investigations made or the procedures followed by
Lazard in rendering its opinion. The issuance of Lazards
opinion was approved by an authorized committee of Lazard.
The following is a brief summary of the material financial and
comparative analyses that Lazard deemed to be appropriate for
this type of transaction and that were reviewed with Critical
Therapeutics board of directors by Lazard in connection
with rendering its opinion. The summary of Lazards
analyses described below is not a complete description of the
analyses underlying Lazards opinion. The preparation of a
financial opinion is a complex analytical process involving
various determinations as to the most appropriate and relevant
methods of financial analyses and the application of those
methods to the particular circumstances, and, therefore, is not
readily susceptible to summary description. In arriving at its
opinion, Lazard considered the results of all of the analyses
and did not draw, in isolation, conclusions from or with regard
to any factor or analysis considered by it. Rather, Lazard made
its determination as to fairness on the basis of its experience
and professional judgment after considering the results of all
of the analyses.
In its analyses, Lazard considered industry performance, general
business, economic, market and financial conditions and other
matters, many of which are beyond the control of Critical
Therapeutics and Cornerstone. No company used in Lazards
analyses is identical to Cornerstone or Critical Therapeutics,
and an evaluation of the results of those analyses is not
entirely mathematical. Rather, the analyses involve complex
considerations and judgments concerning financial and operating
characteristics and other factors that could affect the public
trading or other values of the companies analyzed. The estimates
contained in Lazards analyses and the ranges of valuations
resulting from any particular analysis are not necessarily
indicative of actual values or predictive of future results or
values, which may be significantly more or less favorable than
those suggested by the analyses. In addition, analyses relating
to the value of businesses or securities do not purport to be
appraisals or to reflect the prices at which businesses or
securities actually may be sold. Accordingly, the estimates used
in, and the results derived from, Lazards analyses are
inherently subject to substantial uncertainty.
115
The financial analyses summarized below include information
presented in tabular format. In order to fully understand
Lazards financial analyses, the tables must be read
together with the text of each summary. The tables alone do not
constitute a complete description of the financial analyses.
Considering the data in the tables below without considering the
full narrative description of the financial analyses, including
the methodologies and assumptions underlying the analyses, could
create a misleading or incomplete view of Lazards
financial analyses. For purposes of the analyses summarized
below, the term merger exchange ratio refers to the
implied exchange ratio of 2.9946x, calculated as set forth in
the merger agreement based on the product of 2.3333 multiplied
by the quotient of 43,479,198 divided by the estimate of
Cornerstones management of the fully diluted shares of
Cornerstone common stock as of April 30, 2008 and before
adjustment for the reverse stock split of Critical
Therapeutics common stock to occur in connection with the
merger. For purposes of the Cornerstone Financial
Analyses summarized below, the term implied per
share merger consideration refers to the implied per share
value of $1.86 based on a merger exchange ratio of 2.9946x and
Critical Therapeutics closing stock price on
April 30, 2008 of $0.62 per share.
Cornerstone
Financial Analyses
Discounted
Cash Flow Analysis
Lazard performed a discounted cash flow analysis of Cornerstone
to calculate the estimated present value as of March 31,
2008 of the standalone unlevered, after-tax free cash flows that
Cornerstone was forecasted to generate from the last three
quarters of calendar year 2008 through the full calendar year
2015, based on (i) internal estimates of Cornerstones
management for calendar years 2008 through 2011 and certain
adjustments thereto provided to and discussed with Lazard by
Critical Therapeutics management, which adjustments took
into account more conservative assumptions and estimates with
respect to, among other things, growth prospects for and costs
associated with Cornerstones products and the timing of
new product introductions to the market, and (ii) internal
estimates of Critical Therapeutics management provided to
and discussed with Lazard for calendar years 2012 through 2015.
Lazard calculated estimated terminal values for Cornerstone by
applying a range of earnings before interest, taxes,
depreciation and amortization, referred to as EBITDA, terminal
value multiples of 7.5x to 9.5x to Cornerstones calendar
year 2015 estimated EBITDA. The unlevered, after-tax free cash
flows and terminal values were discounted to present value as of
March 31, 2008 using discount rates ranging from 14.0% to
16.0%. Given that Cornerstone would have no outstanding debt or
cash as of the closing date of the merger, Cornerstones
implied enterprise value was the same as its implied equity
value. Accordingly, in calculating an implied per share equity
reference range for Cornerstone, the implied enterprise value
range derived from the estimated terminal values was divided by
the number of outstanding shares of Cornerstones common
stock. This analysis indicated the following implied per share
equity reference range for Cornerstone, as compared to the
implied per share merger consideration:
|
|
|
Implied Per Share Equity
|
|
Implied Per Share
|
Reference Range for Cornerstone
|
|
Merger Consideration
|
|
$4.50 - $5.50
|
|
$1.86
|
Selected
Publicly Traded Companies Analysis
Lazard reviewed publicly available financial information for the
following six publicly traded mid-stage specialty pharmaceutical
companies:
|
|
|
|
|
Selected Publicly Traded Company
|
|
Enterprise Value (as of April 30, 2008)
|
|
Bentley Pharmaceuticals, Inc.
|
|
$
|
348,200,000
|
|
K-V Pharmaceutical Company
|
|
$
|
1,234,900,000
|
|
Par Pharmaceutical Companies, Inc.
|
|
$
|
498,700,000
|
|
Salix Pharmaceuticals, Ltd.
|
|
$
|
244,400,000
|
|
Sciele Pharma, Inc.
|
|
$
|
839,800,000
|
|
Valeant Pharmaceuticals International
|
|
$
|
1,608,400,000
|
|
Lazard reviewed, among other things, enterprise values of the
selected companies, calculated as market value based on closing
stock prices on April 30, 2008, plus debt and preferred
stock, less cash and cash equivalents,
116
as multiples of estimated revenue and estimated EBITDA for
calendar years 2008, 2009 and 2010. Lazard then applied a range
of selected multiples of estimated revenue for calendar years
2008, 2009 and 2010 of 1.75x to 2.5x, 1.5x to 2.0x and 1.0x to
1.5x, respectively, and estimated EBITDA for calendar years
2008, 2009 and 2010 of 8.0x to 9.0x, 7.0x to 8.0x and 6.0x to
7.0x, respectively, derived from the selected companies,
excluding outliers, to corresponding financial data of
Cornerstone. Estimated financial data of the selected companies
were based on publicly available research analysts
estimates and other publicly available information. Estimated
financial data of Cornerstone were based on internal estimates
of Cornerstones management, as adjusted by Critical
Therapeutics management. This analysis indicated the
following implied per share equity reference range for
Cornerstone based on the financial metrics referred to above
after applying a discount of 15% (which discount was applied to
take into account, among other things, the illiquidity of
Cornerstones stock due to the fact that, unlike the
selected publicly traded companies, Cornerstone is not publicly
traded), as compared to the implied per share merger
consideration:
|
|
|
Implied Per Share Equity
|
|
Implied Per Share
|
Reference Range for Cornerstone
|
|
Merger Consideration
|
|
$3.10 - $4.05
|
|
$1.86
|
Critical
Therapeutics Financial Analyses
Discounted
Cash Flow Analysis
Lazard performed a sum-of-the-parts discounted cash
flow analysis of Critical Therapeutics to calculate the
estimated present value as of March 31, 2008 of the
standalone unlevered, after-tax free cash flows that Critical
Therapeutics product, ZYFLO CR, and product candidates,
zileuton injection, alpha-7 and HMGB1, were forecasted to
generate from the last three quarters of calendar year 2008
through the full calendar year 2015 in the case of Critical
Therapeutics ZYFLO CR product and through the full
calendar year 2020 in the case of Critical Therapeutics
product candidates. Estimated financial data of Critical
Therapeutics were based on internal estimates of Critical
Therapeutics management with respect to Critical
Therapeutics product and product candidates,
probability-weighted, in the case of estimated financial results
attributable to a product candidate, to reflect
managements assessments as to the likelihood of obtaining
regulatory approval to commercialize the product candidate.
Lazard calculated estimated terminal values for Critical
Therapeutics by applying perpetuity growth rates of (10.0%) to
(0.0%) to the estimated unlevered, after-tax free cash flow
attributable in calendar year 2015 to Critical
Therapeutics ZYFLO CR product and to the estimated
unlevered, after-tax free cash flows attributable in calendar
year 2020 to Critical Therapeutics product candidates. The
unlevered, after-tax free cash flows and terminal values were
discounted to present value as of March 31, 2008 using
discount rates ranging from 15.0% to 17.0%. In calculating an
implied per share equity reference range for Critical
Therapeutics, the implied enterprise value range for Critical
Therapeutics derived from the estimated terminal values was
adjusted for Critical Therapeutics net cash (no debt
adjustment was made given that Critical Therapeutics had no
outstanding debt) and such adjusted amount was then divided by
the number of outstanding shares of Critical Therapeutics
common stock. This analysis indicated the following implied per
share equity reference range for Critical Therapeutics, as
compared to the per share closing price of Critical
Therapeutics common stock on April 30, 2008:
|
|
|
Implied Per Share Equity
|
|
Per Share Closing Price of
|
Reference Range for Critical Therapeutics
|
|
Critical Therapeutics Common Stock
|
|
$1.20 - $1.95
|
|
$0.62
|
117
Selected
Publicly Traded Companies Analysis
Lazard reviewed publicly available financial information for the
following 10 publicly traded emerging specialty pharmaceutical
companies:
|
|
|
|
|
Selected Publicly Traded Company
|
|
Enterprise Value (as of April 30, 2008)
|
|
|
Barrier Therapeutics, Inc.
|
|
$
|
41,100,000
|
|
Eurand N.V.
|
|
$
|
724,400,000
|
|
Indevus Pharmaceuticals, Inc.
|
|
$
|
372,200,000
|
|
Inspire Pharmaceuticals, Inc.
|
|
$
|
185,400,000
|
|
ISTA Pharmaceuticals, Inc.
|
|
$
|
73,100,000
|
|
Jazz Pharmaceuticals, Inc.
|
|
$
|
198,000,000
|
|
Noven Pharmaceuticals, Inc.
|
|
$
|
167,000,000
|
|
POZEN Inc.
|
|
$
|
331,800,000
|
|
Santarus, Inc.
|
|
$
|
72,800,000
|
|
Sucampo Pharmaceuticals, Inc.
|
|
$
|
515,400,000
|
|
Lazard reviewed, among other things, enterprise values of the
selected companies as a multiple of estimated revenue for
calendar years 2008, 2009 and 2010. Lazard then applied a range
of selected multiples of estimated revenue for calendar years
2008, 2009 and 2010 of 1.5x to 2.25x, 1.0x to 1.5x and 0.75x to
1.25x, respectively, derived from the selected companies to
corresponding financial data of Critical Therapeutics. Estimated
financial data of the selected companies were based on publicly
available research analysts estimates and other publicly
available information. Estimated financial data of Critical
Therapeutics were based on internal estimates of Critical
Therapeuticss management with respect to Critical
Therapeutics product and product candidates,
probability-weighted, in the case of estimated financial results
attributable to a product candidate, to reflect
managements assessments as to the likelihood of obtaining
regulatory approval to commercialize the product candidate. This
analysis indicated the following implied per share equity
reference range for Critical Therapeutics based on the financial
metrics referred to above, as compared to the per share closing
price of Critical Therapeutics common stock on
April 30, 2008:
|
|
|
Implied Per Share Equity
|
|
Per Share Closing Price of
|
Reference Range for Critical Therapeutics
|
|
Critical Therapeutics Common Stock
|
|
$1.20 - $1.55
|
|
$0.62
|
Implied
Pro Forma Ownership Analyses
Using the implied equity reference ranges for Cornerstone and
Critical Therapeutics derived from the Discounted Cash
Flow Analysis and Selected Publicly Traded Companies
Analysis described above, Lazard derived an implied equity
ownership percentage for Cornerstones stockholders in the
combined company upon consummation of the merger. This analysis
indicated the following range of implied pro forma equity
ownership percentages for Cornerstones stockholders, as
compared to the pro forma equity ownership percentage for
Cornerstones stockholders implied by the merger exchange
ratio:
|
|
|
|
|
Cornerstone Implied Pro Forma Equity Ownership
|
|
|
Percentage Reference Ranges
|
|
|
|
|
Selected Publicly
|
|
Cornerstone Pro Forma
|
Discounted
|
|
Traded Companies
|
|
Equity Ownership Percentage
|
Cash Flow Analysis
|
|
Analysis
|
|
Implied by Merger Exchange Ratio
|
|
64% - 77%
|
|
60% - 73%
|
|
70.0%
|
Miscellaneous
In connection with Lazards services as Critical
Therapeutics financial advisor, Critical Therapeutics has
agreed to pay to Lazard an aggregate fee of approximately
$1.25 million, a portion of which was payable upon the
rendering of Lazards opinion and approximately
$1.0 million of which is contingent upon the closing of the
merger. Critical Therapeutics also has agreed to reimburse
Lazard for its reasonable expenses,
118
including reasonable attorneys fees, and to indemnify
Lazard and certain related parties against certain liabilities
that may arise out of the rendering of its advice, including
certain liabilities under U.S. federal securities laws.
Lazard, as part of its investment banking business, is
continually engaged in the valuation of businesses and their
securities in connection with mergers and acquisitions,
negotiated underwritings, secondary distributions of listed and
unlisted securities, private placements, leveraged buyouts, and
valuations for estate, corporate and other purposes. Lazard in
the past has provided and in the future may provide investment
banking services to Critical Therapeutics, for which Lazard has
received and may receive compensation, including having acted as
exclusive financial advisor to Critical Therapeutics in
connection with a licensing transaction in 2007, for which
Lazard was paid an aggregate fee of approximately
$1.2 million. In addition, Lazard Capital Markets LLC, or
LCM, an entity indirectly owned in large part by managing
directors of Lazard, acted as sole placement agent in connection
with an equity offering of Critical Therapeutics in 2006, for
which LCM was paid an aggregate fee of approximately
$1.2 million, a portion of which was paid by LCM to Lazard
as a referral fee. In the ordinary course of their respective
businesses, affiliates of Lazard and LCM may actively trade
securities of Critical Therapeutics for their own accounts and
for the accounts of their customers and, accordingly, may at any
time hold a long or short position in such securities.
Lazard is an internationally recognized investment banking firm
providing a full range of financial advisory and securities
services. Lazard was selected to act as Critical
Therapeutics financial advisor because of its
qualifications, experience and reputation in investment banking
and mergers and acquisitions and its familiarity with Critical
Therapeutics.
Lazard prepared the above analyses for the purpose of providing
an opinion to Critical Therapeutics board of directors as
to the fairness, from a financial point of view, to Critical
Therapeutics of the exchange ratio. Lazard did not recommend any
specific consideration to Critical Therapeutics board of
directors or that any given consideration constituted the only
appropriate consideration for the merger.
Lazards opinion and analyses were only one of many factors
taken into consideration by Critical Therapeutics board of
directors in its evaluation of the merger. Consequently, the
analyses described above should not be viewed as determinative
of the views of Critical Therapeutics board of directors
or Critical Therapeutics management with respect to the
exchange ratio or as to whether Critical Therapeutics
board of directors would have been willing to determine that a
different consideration was fair.
Interests
of Critical Therapeutics Directors and Executive Officers
in the Merger
In considering the recommendation of Critical Therapeutics
board of directors with respect to issuing shares of Critical
Therapeutics common stock as contemplated by the merger
agreement and the other matters to be acted upon by Critical
Therapeutics stockholders at the special meeting, Critical
Therapeutics stockholders should be aware that members of
the board of directors and executive officers of Critical
Therapeutics have interests in the merger that are different
from, or in addition to, the interests of Critical
Therapeutics stockholders. Critical Therapeutics and
Cornerstones boards of directors were aware of these
potential conflicts of interest and considered them, among other
matters, in reaching their respective decisions to approve the
merger agreement and the merger, in the case of
Cornerstones board of directors, to recommend that
Cornerstones stockholders vote to adopt the merger
agreement, and, in the case of Critical Therapeutics board
of directors, to recommend that Critical Therapeutics
stockholders vote to approve the issuance of Critical
Therapeutics common stock in connection with the merger
and the other matters to be acted upon by Critical
Therapeutics stockholders at the special meeting.
Ownership
Interests
Assuming that the merger had been consummated on
September 15, 2008, the beneficial ownership and other
equity interests in the combined company immediately following
the merger of Mr. Townsend, who is
119
expected to serve as General Counsel, Executive Vice President
of Legal Affairs and Secretary of the combined company, are
expected to be as set forth below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
Options
|
|
|
Company
|
|
|
|
Shares
|
|
|
Total
|
|
|
Exercisable
|
|
|
Beneficial
|
|
|
|
Beneficially
|
|
|
Options
|
|
|
Within
|
|
|
Ownership
|
|
Name
|
|
Owned
|
|
|
Held
|
|
|
60 Days
|
|
|
Percentage
|
|
|
Scott B. Townsend(1)
|
|
|
1,751,672
|
|
|
|
244,000
|
|
|
|
167,015
|
|
|
|
1.4
|
%
|
|
|
|
(1) |
|
In anticipation of Mr. Townsends service to the
combined company following the merger, on September 16,
2008, Critical Therapeutics entered into a restricted stock
agreement that provides for a restricted stock grant to
Mr. Townsend on the first business day after the
consummation of the merger of a number of shares of common stock
representing one percent of the combined companys
outstanding equity, on a fully diluted basis but excluding an
aggregate of 7,208,707 shares of Critical
Therapeutics common stock underlying warrants issued in
connection with a June 2005 private placement and an October
2006 registered offering, after giving effect to the reverse
stock split and the merger. The restricted stock agreement will
only become effective if the merger is consummated. It is
expected that approximately 1,489,789 shares will be issued
to Mr. Townsend pursuant to the restricted stock agreement,
subject to adjustment as a result of the reverse stock split. |
As of September 15, 2008, all directors and executive
officers of Critical Therapeutics, together with their
affiliates, beneficially owned approximately 23.2% of the shares
of Critical Therapeutics common stock. The affirmative
vote of the holders of a majority of the shares of Critical
Therapeutics common stock present in person or represented
by proxy and voting on such matter at the special meeting is
required for approval of Proposal 1 and Proposal 4.
The affirmative vote of holders of a majority of the outstanding
shares of Critical Therapeutics common stock as of the
record date for the special meeting is required for approval of
Proposal 2 and Proposal 3.
Employment
Agreements
Critical Therapeutics has entered into employment agreements
with each of its executive officers. In December 2004, Critical
Therapeutics entered into employment agreements with
Dr. Phillips and Mr. Townsend. In June 2006, Critical
Therapeutics entered into an employment agreement with Jeffrey
E. Young, Vice President of Finance, Chief Accounting Officer
and Treasurer. In August 2007, Critical Therapeutics entered
into an employment agreement with Mr. Kelly. In November
2007, Critical Therapeutics entered into amended and restated
employment agreements with Dr. Phillips, Mr. Townsend
and Mr. Young. In April 2008, Critical Therapeutics entered
into a further amended and restated employment agreement with
Dr. Phillips in connection with his appointment as
President and Chief Executive Officer.
Each of the employment agreements with its current executive
officers, other than with Mr. Kelly, has an initial term
that extends through December 31, 2009.
Mr. Kellys employment agreement has an initial term
that extends through December 31, 2008. Each of these
employment agreements automatically extends for an additional
one-year term after the initial term unless either Critical
Therapeutics or the executive officer gives
90-days
prior notice.
Under the employment agreements, each executive officer is paid
a base salary and is eligible for an annual cash bonus of a
specified percentage of his annual base salary and an annual
equity award. The employment agreements provide for an annual
base salary of $330,000 for Dr. Phillips, $279,500 for
Mr. Kelly, $275,000 for Mr. Townsend and $202,800 for
Mr. Young and an annual target cash bonus as a percentage
of base salary of 40% for Dr. Phillips, 30% for
Mr. Kelly, 30% for Mr. Townsend and 30% for
Mr. Young.
Each employment agreement with the current executive officers of
Critical Therapeutics provides that if Critical Therapeutics
terminates the executive officers employment other than
for cause or if the executive officer terminates his
employment for good reason, in each case as those
terms are defined in his employment agreement, then Critical
Therapeutics is obligated to provide the following to the
executive
120
officer, provided such person executes and delivers to Critical
Therapeutics a severance agreement and release drafted by and
satisfactory to counsel to Critical Therapeutics:
|
|
|
|
|
a lump sum payment equal to his annual base salary in effect at
that time for each executive officer other than
Dr. Phillips, and a lump sum payment equal to 1.25 times
his annual base salary in effect at that time for
Dr. Phillips;
|
|
|
|
monthly payments in the amount of 100% of the monthly COBRA
premiums for continued health and dental coverage for the
executive officer and his dependents for each executive officer
other than Mr. Kelly, and 80% of the monthly COBRA premiums
for continued health and dental coverage for Mr. Kelly and
his dependents, and 100% of the amount of the monthly premiums
paid by Critical Therapeutics for life insurance and disability
insurance for the executive officer until the earlier of one
year, or in the case of Dr. Phillips 15 months, after
termination or the last day of the first month when such officer
is eligible for benefits through other employment;
|
|
|
|
a pro rata payment of his target cash bonus in effect in the
year of termination; and
|
|
|
|
accelerated vesting of 50% of his outstanding unvested stock
options and restricted stock.
|
Immediately upon a change of control of Critical
Therapeutics, as defined in his employment agreement, each
executive officer is entitled to accelerated vesting of 50% of
all his outstanding unvested stock options and restricted stock.
In addition, Dr. Phillips is entitled to receive a one-time
lump sum payment of $175,000 upon a change of control.
If Critical Therapeutics terminates the executive officers
employment other than for cause or if the executive
officer terminates his employment for good reason
during the period from three months before until one year after
the occurrence of a change of control, then Critical
Therapeutics is obligated to provide the following to the
executive officer, provided such person executes and delivers to
Critical Therapeutics a severance agreement and release drafted
by and satisfactory to counsel to Critical Therapeutics:
|
|
|
|
|
lump sum payment equal to his annual base salary in effect at
that time for each executive officer other than
Dr. Phillips, and a lump sum payment equal to 1.5 times his
annual base salary in effect at that time for Dr. Phillips;
|
|
|
|
monthly payments in the amount of 100% of the monthly COBRA
premiums for continued health and dental coverage for the
executive officer and his dependents for each executive officer
other than Mr. Kelly and 80% of the monthly COBRA premiums
for continued health and dental coverage for Mr. Kelly and
his dependents, and 100% of the amount of the monthly premiums
paid by Critical Therapeutics for life insurance and disability
insurance for the executive officer until the earlier of one
year, or in the case of Dr. Phillips 18 months, after
termination or the last day of the first month when such officer
is eligible for benefits through other employment;
|
|
|
|
a pro rata payment of his target cash bonus in effect in the
year of termination;
|
|
|
|
accelerated vesting of 100% of his outstanding unvested stock
options and restricted stock; and
|
|
|
|
up to three months of outplacement services.
|
Upon voluntary resignation, each executive officer is entitled
to a pro rata payment of his annual bonus from the previous year
provided that the executive officer gives
90-days
prior written notice of resignation and executes a release of
Critical Therapeutics.
Each executive officer has agreed not to compete with Critical
Therapeutics during his employment with Critical Therapeutics
and for a one-year period after termination of employment by
Critical Therapeutics for any reason or after a change of
control of Critical Therapeutics. In the event of a breach
of this non-competition obligation, Critical Therapeutics will
be entitled to injunctive relief in addition to any other
remedies it might have, and the executive will continue to be
held to the obligation until the requisite time period has
passed without any violation. Each executive officer has also
agreed not to disclose any confidential information obtained
during his employment. The severance agreements and releases
used by
121
Critical Therapeutics typically contain provisions, whereby a
departing executive reaffirms these obligations, and
non-disparagement clauses of perpetual duration, compliance with
which is a condition to the receipt of payments.
In anticipation of Mr. Townsends service to the
combined company following the merger, on September 16,
2008, Critical Therapeutics entered into an amendment to the
amended and restated employment agreement between Critical
Therapeutics and Mr. Townsend. This amendment will be
effective from the effective time of the merger to
December 31, 2010 and will only become effective if the
merger is consummated. Under the terms of this amendment,
Mr. Townsend will serve as the General Counsel, Executive
Vice President of Legal Affairs and Secretary of the combined
company. The amendment provides for an increase in
Mr. Townsends annual target cash bonus as a
percentage of base salary from 30% to 35% and an actual annual
cash bonus for Mr. Townsend for 2008 of not less than 35%
of his base salary if he remains an employee in good standing
through December 31, 2008. Mr. Townsend will continue
to receive an annual base salary of $275,000. Mr. Townsend
also will be eligible to participate in all of the combined
companys benefit plans and programs, including a car
allowance, as provided to other vice president or executive vice
president level executives at Cornerstone. Because it is
expected that Mr. Townsend may, for some period of time,
continue to reside in Massachusetts following the relocation of
the combined company to North Carolina, Mr. Townsend also
will be reimbursed for related business travel expenses and
temporary lodging while in North Carolina and expenses related
to a home office in Massachusetts.
In connection with such amendment, on September 16, 2008,
Critical Therapeutics also entered into a restricted stock
agreement with Mr. Townsend that provides for a restricted
stock grant to Mr. Townsend on the first business day after
the consummation of the merger of a number of shares of common
stock representing one percent of the combined companys
outstanding equity, on a fully diluted basis but excluding an
aggregate of 7,208,707 shares of Critical Therapeutics
common stock underlying warrants issued in connection with a
June 2005 private placement and an October 2006
registered offering, after giving effect to the reverse stock
split and the merger, subject to the terms of such restricted
stock agreement. The restricted stock agreement will only become
effective if the merger is consummated. It is expected that
approximately 1,489,789 shares will be issued to
Mr. Townsend pursuant to the restricted stock agreement,
subject to adjustment as a result of the reverse stock split.
This restricted stock award will vest as to 25% of the shares
subject to the award on May 1, 2009, 25% of the shares on
May 1, 2010, 25% of the shares on May 1, 2011 and 25%
of the shares on May 1, 2012.
The amendment to Mr. Townsends amended and restated
employment agreement specifically recognizes that the relocation
of the combined company to North Carolina constitutes good
reason under his amended and restated employment
agreement. Accordingly, the amendment provides that if
Mr. Townsends employment is terminated at any time on
or before December 31, 2009 by the combined company without
cause, by Mr. Townsend for good reason or because of
Mr. Townsends death or disability, the combined
company will provide to Mr. Townsend or his estate, as
applicable, the payments and benefits described above pursuant
to his existing amended and restated employment agreement.
However, if Mr. Townsend resigns his employment for good
reason prior to December 31, 2009 related to the relocation
of the combined company, the accelerated vesting of his
outstanding unvested stock options and restricted stock will not
include the restricted stock granted pursuant to the restricted
stock agreement dated September 16, 2008. If
Mr. Townsends employment is terminated by the
combined company without cause prior to December 31, 2009,
then vesting will accelerate with respect to 35% of the
restricted stock granted pursuant to the restricted stock
agreement dated September 16, 2008, unless such termination
is during a change of control period relating to a
transaction other than the merger with Cornerstone, in which
case, the vesting will accelerate with respect to 100% of the
restricted stock granted pursuant to the restricted stock
agreement dated September 16, 2008. Mr. Townsend would
be entitled to the payments and benefits described above
pursuant to his existing amended and restated employment
agreement if his employment is terminated after
December 31, 2009 by the combined company without cause or
by Mr. Townsend for good reason not related to the
relocation of the combined company.
122
Cash
Bonus Awards Upon a Change in Control
On July 16, 2008, based on the recommendation of the
compensation committee, Critical Therapeutics board of
directors established a bonus program for Critical
Therapeutics executive officers providing for Critical
Therapeutics to pay cash bonuses to its executive officers,
other than Dr. Phillips, who remain employed with Critical
Therapeutics and satisfactorily perform their job duties, as
determined by Critical Therapeutics, upon the consummation of
the merger or any other change in control of
Critical Therapeutics, as defined in Critical Therapeutics
2004 Stock Incentive Plan, as amended. This cash bonus also
would be payable if Critical Therapeutics terminates an
executive officers employment without cause,
as defined in his employment agreement, within 28 days
before the occurrence of a change in control, provided the
executive officer executes and delivers to Critical Therapeutics
a severance agreement and release drafted by and satisfactory to
Critical Therapeutics. These cash bonuses are in addition to
compensation and benefits otherwise payable to these executive
officers under their employment agreements. Under this bonus
program, the executive officers listed below are entitled to the
following bonus amounts:
|
|
|
|
|
Name
|
|
Cash Bonus Amount
|
|
|
Thomas P. Kelly
|
|
$
|
45,000
|
|
Scott B. Townsend, Esq.
|
|
|
50,000
|
|
Jeffrey E. Young
|
|
|
35,000
|
|
As discussed above, pursuant to the terms of his employment
agreement, Dr. Phillips is separately entitled to receive a
lump sum payment of $175,000 upon a change in
control of Critical Therapeutics, as defined in his
employment agreement.
Summary
of Potential Payments in Connection with the
Merger
Promptly following the effective time of the merger, the
executive management team of the combined company is expected to
be composed primarily of current Cornerstone executives, except
that Mr. Townsend is expected to serve as General Counsel,
Executive Vice President of Legal Affairs and Secretary of the
combined company. Accordingly, it is contemplated that Critical
Therapeutics executive officers will be entitled to
payments in connection with the consummation of the merger,
which constitutes a change in control under each
executives employment agreement and Critical
Therapeutics 2004 Stock Incentive Plan, as amended.
The following table sets forth information regarding payments
and benefits that each executive officer of Critical
Therapeutics would receive in connection with the consummation
of the merger pursuant to the terms of his employment agreement
or the change of control cash bonus program
described above, as applicable, assuming that the merger had
been consummated on September 15, 2008 and, as applicable,
such executives employment was terminated on such date.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immediately Upon a Change of Control
|
|
|
Termination in Connection with a Change of Control
|
|
|
|
|
|
|
Value of
|
|
|
Value of
|
|
|
|
|
|
|
|
|
Value of
|
|
|
Value of
|
|
|
|
|
|
|
Options
|
|
|
Stock
|
|
|
|
|
|
|
|
|
Options
|
|
|
Stock
|
|
|
|
|
|
|
with
|
|
|
with
|
|
|
|
|
|
|
|
|
with
|
|
|
with
|
|
|
|
Cash
|
|
|
Accelerated
|
|
|
Accelerated
|
|
|
Cash
|
|
|
Value of
|
|
|
Accelerated
|
|
|
Accelerated
|
|
Name
|
|
Payment
|
|
|
Vesting(1)
|
|
|
Vesting(2)
|
|
|
Payments(3)
|
|
|
Benefits(4)
|
|
|
Vesting(1)
|
|
|
Vesting(2)
|
|
|
Trevor Phillips, Ph.D.
|
|
$
|
175,000
|
|
|
|
|
|
|
$
|
4,654
|
|
|
$
|
756,625
|
|
|
$
|
29,650
|
|
|
|
|
|
|
$
|
9,308
|
|
Thomas P. Kelly
|
|
|
45,000
|
|
|
|
|
|
|
|
4,747
|
|
|
|
387,388
|
|
|
|
16,145
|
|
|
|
|
|
|
|
9,494
|
|
Scott B. Townsend, Esq.(5)
|
|
|
50,000
|
|
|
|
|
|
|
|
4,747
|
|
|
|
386,875
|
|
|
|
21,375
|
|
|
|
|
|
|
|
9,494
|
|
Jeffrey E. Young
|
|
|
35,000
|
|
|
|
|
|
|
|
2,831
|
|
|
|
283,430
|
|
|
|
20,981
|
|
|
|
|
|
|
|
5,661
|
|
|
|
|
(1) |
|
The amounts in this column are calculated based on the
difference between $0.22, the closing market price per share of
Critical Therapeutics common stock on September 15,
2008, and the exercise price per share of the options subject to
accelerated vesting. All options subject to accelerated vesting
have an exercise price greater than $0.22 per share. |
123
|
|
|
(2) |
|
The amounts in this column are calculated by multiplying the
number of shares subject to accelerated vesting by $0.22, the
closing market price per share of Critical Therapeutics
common stock on September 15, 2008. |
|
(3) |
|
The amounts in this column reflect (i) a lump sum payment
equal to annual base salary in effect on September 15,
2008, or in the case of Dr. Phillips, a lump sum payment
equal to 1.5 times annual base salary in effect on
September 15, 2008, and (ii) a pro rata payment of the
target cash bonus for 2008 for the executive officer. The amount
for Dr. Phillips includes the $175,000 payment that he would be
entitled to receive under his employment agreement upon the
consummation of a change in control. The amount for each other
executive officer includes the payment that such executive
officer would be entitled to receive under the change in
control cash bonus program. |
|
(4) |
|
The amounts in this column reflect 12 monthly payments in
the amount of (i) 100% of the monthly COBRA premiums for
continued health and dental coverage for the executive officer
and his dependents, or 80% in the case of Mr. Kelly, and
(ii) 100% of the amount of life insurance and disability
insurance for the executive officer in the month prior to
termination for 12 months, or 18 months in the case of
Dr. Phillips, if Critical Therapeutics terminates his
employment other than for cause or if he terminates
his employment for good reason during the period
from three months before until one year after the occurrence of
a change of control. In addition, the amounts in this column
include $5,000, which is an estimate of the fair market value of
up to three months of outplacement services that would be
provided to such executives if Critical Therapeutics terminates
the executives employment other than for cause
or if an executive terminates his employment for good
reason during the period from three months before until
one year after the occurrence of a change of control. |
|
(5) |
|
Mr. Townsend is expected to serve as General Counsel,
Executive Vice President of Legal Affairs and Secretary of the
combined company. |
Director
Stock Option Agreements
Critical Therapeutics directors Jean George and Richard W.
Dugan are parties to stock option agreements with Critical
Therapeutics that provide for accelerated vesting of the stock
options granted pursuant to such agreements upon a change of
control of Critical Therapeutics. All stock options subject to
accelerated vesting have an exercise price that is greater than
$0.22 per share, the closing market price per share of
Critical Therapeutics common stock on September 15,
2008.
Indemnification
of Officers and Directors
The merger agreement provides that, for a period of six years
following the effective time of the merger, Critical
Therapeutics will, to the fullest extent permitted by law,
indemnify and hold harmless each present and former director and
officer of Critical Therapeutics against any costs or expenses
(including attorneys fees), judgments, fines, losses,
claims, damages, liabilities or amounts paid in settlement
incurred in connection with any claim, action, suit, proceedings
or investigation, whether civil, criminal, administrative or
investigative, arising out of or pertaining to matters existing
or occurring at or prior to the effective time of the merger,
whether asserted or claimed prior to, at or after the effective
time of the merger, to the fullest extent that Critical
Therapeutics or one of its subsidiaries, as the case may be,
would have been permitted under Delaware law and its certificate
of incorporation or bylaws.
The merger agreement also provides that, for a period of six
years following the effective time of the merger, Critical
Therapeutics will maintain in effect a directors and
officers liability insurance policy covering the directors
and officers of Critical Therapeutics, with coverage in amount
and scope at least as favorable as the coverage under Critical
Therapeutics existing policy as of the time the merger
becomes effective. If the annual premiums payable for such
insurance coverage exceed 150% of the current annual premiums
paid by Critical Therapeutics for its existing policy, Critical
Therapeutics will provide the maximum coverage that will then be
available at an annual premium equal to 150% of such rate.
124
Interests
of Cornerstones Directors and Executive Officers in the
Merger
Members of the board of directors and executive officers of
Cornerstone may have interests in the merger that are different
from, or are in addition to, the interests of Cornerstones
stockholders generally. These interests generally include, among
other things, the potential for such persons to occupy positions
as officers or directors of the combined company and the
potential benefits under employment or severance arrangements as
a result of the merger. The Cornerstone board of directors was
aware of these interests and considered them, among other
matters, in approving the merger agreement and in determining to
recommend that Cornerstones stockholders vote to approve
and adopt the merger agreement.
Board
of Directors and Management
Craig A. Collard is the Chief Executive Officer and a member of
the board of directors of Cornerstone and, upon closing of the
merger, Mr. Collard will become the President, Chief
Executive Officer and a director of the combined company.
Mr. Collard participated in the negotiation and approval of
the terms of the merger on behalf of Cornerstone.
Following the merger, in addition to Mr. Collard, certain
other directors and members of the senior management of
Cornerstone will assume new positions with the combined company.
Alastair McEwan is the Chairman of Cornerstone and, upon closing
of the merger, will become a director of the combined company.
Chenyqua Baldwin is the Vice President of Finance of Cornerstone
and, upon closing of the merger, will become the Chief
Accounting Officer, Controller and Vice President of Finance of
the combined company. Brian Dickson, M.D. is the Chief
Medical Officer of Cornerstone and, upon the closing of the
merger, will hold the same position in the combined company.
George Esgro is the Vice President of Sales and Marketing of
Cornerstone and, upon the closing of the merger, will hold the
same position in the combined company. Steven M. Lutz is the
Executive Vice President of Commercial Operations of Cornerstone
and, upon closing of the merger, will become the Executive Vice
President of Manufacturing and Trade in the combined company.
David Price became the Executive Vice President, Finance, and
Chief Financial Officer of Cornerstone on September 8,
2008, and will hold the same positions in the combined company.
Mr. McEwan, Ms. Baldwin, Dr. Dickson,
Mr. Esgro, Mr. Lutz and Mr. Price participated in the
negotiation of the terms of the merger. For a more complete
description of the management of the combined company after the
merger, please see the section Management Following the
Merger beginning on page 294 of this proxy
statement/prospectus.
Ownership
Interests
As of September 15, 2008, all directors and executive
officers of Cornerstone, together with their associates, held
interests in 18,295,000 shares of Cornerstones common
stock representing approximately 73.4% of Cornerstones
issued and outstanding common stock as of such date, including
13,450,000 shares owned by Cornerstone Biopharma Holdings,
Ltd., an entity which is wholly-owned by Mr. Collard, and
1,250,000 shares owned by the Craig Collard Irrevocable
Trust, a trust in which Mr. Collard has a substantial
beneficial interest.
Assuming that the merger had been consummated on
September 15, 2008, Cornerstones executive officers
and directors, and their affiliates, would beneficially own, in
the aggregate, approximately 51% of the outstanding common stock
of the combined company, including any shares of the common
stock of the combined company issuable in the merger in exchange
for shares of Cornerstones outstanding common stock to be
issued to Carolina Pharmaceuticals upon the exchange or
conversion prior to the merger of the outstanding principal
amount under the Carolina Note into shares of Cornerstones
common stock pursuant to the noteholder agreement between
Carolina Pharmaceuticals and Critical Therapeutics.
Additionally, Cornerstones executive officers and
directors would hold certain options to acquire shares of the
common stock of the combined company that are not considered
beneficially owned because such options are not exercisable
within sixty days of September 15, 2008. Assuming that the
merger had been consummated on September 15, 2008 and
assuming an exchange ratio of
125
2.449169, the beneficial ownership and other equity interests of
Cornerstones executive officers and directors, and their
affiliates, in the combined company immediately following the
merger are expected to be as set forth below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Combined
|
|
|
|
Total
|
|
|
|
|
|
Options
|
|
|
Company
|
|
|
|
Shares
|
|
|
Total
|
|
|
Exercisable
|
|
|
Beneficial
|
|
|
|
Beneficially
|
|
|
Options
|
|
|
Within
|
|
|
Ownership
|
|
Name
|
|
Owned
|
|
|
Held
|
|
|
60 Days
|
|
|
Percentage
|
|
|
Craig A. Collard(1)
|
|
|
48,115,201
|
|
|
|
2,571,627
|
|
|
|
734,750
|
|
|
|
38.2
|
%
|
Chenyqua Baldwin
|
|
|
2,430,799
|
|
|
|
2,057,301
|
|
|
|
593,923
|
|
|
|
1.9
|
|
Brian Dickson, M.D.
|
|
|
1,637,881
|
|
|
|
3,673,752
|
|
|
|
1,637,881
|
|
|
|
1.3
|
|
George Esgro(2)
|
|
|
|
|
|
|
734,750
|
|
|
|
|
|
|
|
|
|
Steven M. Lutz
|
|
|
7,656,712
|
|
|
|
2,265,480
|
|
|
|
688,828
|
|
|
|
6.1
|
|
Alastair McEwan
|
|
|
2,755,314
|
|
|
|
3,673,752
|
|
|
|
2,755,314
|
|
|
|
2.2
|
|
David Price(3)
|
|
|
3,188,268
|
|
|
|
|
|
|
|
|
|
|
|
2.5
|
|
|
|
|
(1) |
|
Total shares beneficially owned consists of
32,941,317 shares of common stock held by Cornerstone
Biopharma Holdings, Ltd., 14,439,134 shares of common stock
held by Carolina Pharmaceuticals received in connection with the
conversion of the outstanding principal amount under the
Carolina Note and options to purchase 734,239 shares of
common stock pursuant to stock option grants awarded to
Mr. Collard under Cornerstones 2005 Stock Incentive
Plan. Mr. Collard is the controlling shareholder and a
director of Cornerstone Biopharma Holdings, Ltd. and by virtue
of such positions will exercise voting and investment power with
respect to the shares of the combined company to be owned by
Cornerstone Biopharma Holdings, Ltd. following the merger.
Mr. Collard is the chief executive officer and chairman of
the board of Carolina Pharmaceuticals and by virtue of such
positions will exercise voting and investment power with respect
to the shares of the combined company to be owned by Carolina
Pharmaceuticals following the merger. |
|
(2) |
|
Pursuant to the Employment Agreement, dated March 3, 2008,
between Cornerstone and Mr. Esgro, Cornerstone is obligated
to grant Mr. Esgro an option to purchase
300,000 shares of Cornerstones common stock.
Cornerstone expects that the option award to Mr. Esgro will
be completed immediately prior to the effective time of the
merger. |
|
(3) |
|
Mr. Price became the Executive Vice President, Finance, and
Chief Financial Officer of Cornerstone effective as of
September 8, 2008. Pursuant to the Executive Employment
Agreement, dated August 20, 2008, between Cornerstone and
Mr. Price, Cornerstone is obligated to issue to
Mr. Price 1,301,776 restricted shares of Cornerstone common
stock. Cornerstone expects that this restricted stock award to
Mr. Price will be completed immediately prior to the
effective time of the merger. In connection with the merger,
Mr. Prices 1,301,776 restricted shares of Cornerstone
common stock will be converted into restricted shares of the
combined companys common stock. |
For a more complete description of the ownership interests of
the executive officers and directors of Cornerstone, please see
the sections entitled Principal Stockholders of
Cornerstone beginning on page 347 of this proxy
statement/prospectus and Principal Stockholders of
Combined Company beginning on page 349 of this proxy
statement/prospectus.
Stock
Options
Under the terms of the merger agreement, at the effective time
of the merger, each outstanding option to purchase shares of
Cornerstone common stock, whether vested or unvested, will be
assumed by Critical Therapeutics and will become an option to
acquire, on the same terms and conditions as were applicable
under the stock option agreement by which such option is
evidenced and the stock option plan under which such option was
issued, if any, shares of Critical Therapeutics common
stock. The number of shares of Critical Therapeutics
common stock subject to each assumed option will be determined
by multiplying the number of shares of Cornerstone common stock
that was subject to each option prior to the effective time of
the merger by an exchange ratio determined pursuant to the
merger agreement, and rounding that result down
126
to the nearest whole number of shares of Critical
Therapeutics common stock. The per share exercise price
for the assumed options will be determined by dividing the per
share exercise price of the Cornerstone common stock subject to
each option as in effect immediately prior to the effective time
of the merger by the exchange ratio and rounding that result up
to the nearest whole cent. The exact exchange ratio per share of
Cornerstones common stock will be based in part on the
number of shares of Cornerstones common stock outstanding
on a fully diluted basis immediately prior to the effective time
of the merger and will not be calculated until that time. For a
more complete description of the merger, please see the section
entitled The Merger Agreement beginning on
page 137 of this proxy statement/prospectus.
The table below sets forth, as of September 15, 2008,
information with respect to options held by each of
Cornerstones executive officers and directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
Exercise
|
|
|
|
Options
|
|
|
|
|
|
|
|
|
Price Per
|
|
Name
|
|
Held
|
|
|
Vested
|
|
|
Unvested
|
|
|
Share
|
|
|
Craig A. Collard
|
|
|
1,050,000
|
|
|
|
300,000
|
|
|
|
750,000
|
|
|
$
|
0.40
|
|
Chenyqua Baldwin
|
|
|
840,000
|
|
|
|
242,500
|
|
|
|
597,500
|
|
|
|
0.39
|
|
Brian Dickson, M.D.
|
|
|
1,500,000
|
|
|
|
668,750
|
|
|
|
831,250
|
|
|
|
0.26
|
|
George Esgro(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven M. Lutz
|
|
|
925,000
|
|
|
|
281,250
|
|
|
|
643,750
|
|
|
|
0.36
|
|
Alastair McEwan
|
|
|
1,500,000
|
|
|
|
1,125,000
|
|
|
|
375,000
|
|
|
|
0.21
|
|
David Price(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Pursuant to the Employment Agreement, dated March 3, 2008,
between Cornerstone and Mr. Esgro, Cornerstone is obligated
to grant Mr. Esgro an option to purchase
300,000 shares of Cornerstones common stock.
Cornerstone expects that the option award to Mr. Esgro will
be completed immediately prior to the effective time of the
merger. |
|
(2) |
|
Mr. Price entered into an Employment Agreement with Cornerstone
pursuant to which he became the Executive Vice President,
Finance, and Chief Financial Officer of Cornerstone, effective
September 8, 2008. Mr. Price also entered into a
Restricted Stock Agreement pursuant to which he will receive
1,301,776 shares of restricted stock of Cornerstone
immediately prior to the consummation of the merger with
Critical Therapeutics. The restricted stock will vest 25% on
each of the first four anniversaries of August 20, 2008. |
Noteholder
Agreement with Carolina Pharmaceuticals
In April 2004, Cornerstone entered into the Carolina Note, an
unsecured loan agreement with Carolina Pharmaceuticals, whereby
Cornerstone could borrow up to $15.0 million at 10%
interest for five years. Because Mr. Collard is the Chief
Executive Officer and Chairman of the Board of Carolina
Pharmaceuticals, he is a control person of Carolina
Pharmaceuticals. In addition, Ms. Baldwin and Mr. Lutz are each
directors of Carolina Pharmaceuticals. Cornerstone borrowed
$13.0 million under the Carolina Note in April 2004. In
June 2006, Cornerstone entered into a note amendment and waiver
agreement that provided for the offset of approximately
$3.6 million in principal and $1.8 million in accrued
interest outstanding under the Carolina Note against equal
amounts due to Cornerstone from Cornerstone Biopharma Holdings,
Ltd. and Carolina Pharmaceuticals. The amounts due to
Cornerstone primarily resulted from the 2005 Adams litigation
settlement. As of December 31, 2007 and 2006, approximately
$9.4 million in principal was outstanding under the
Carolina Note plus approximately $549,000 and $1.5 million
in accrued interest, respectively. On April 11, 2008,
Cornerstone made a principal payment of $460,000 on the Carolina
Note. The outstanding principal and accrued interest are due in
2009. As of September 15, 2008, the outstanding principal
amount of the Carolina Note was approximately $9.0 million.
Carolina Pharmaceuticals, which is the holder of the Carolina
Note, has entered into an agreement that provides, among other
things, for the exchange or conversion of the outstanding
principal amount of the Carolina Note into approximately 18% of
the shares of Cornerstones common stock outstanding
immediately
127
prior to the effective time of the merger and for the same
voting and
lock-up
provisions provided pursuant to the agreements entered into by
Cornerstones other stockholders.
Employment
and Related Agreements
Cornerstone is party to employment agreements with its executive
officers. These agreements provide that the executive officer is
entitled to minimum annual base salary, an annual bonus,
severance, and certain health, retirement, and other benefits.
The material terms of these agreements have been summarized in
the section Narrative Disclosure to Summary Compensation
Table and Grants of Plan-Based Awards Table beginning on
page 312 of this proxy statement/prospectus. The
individuals who are parties to these agreements, as well as
their positions and annual base salaries, are as follows:
(i) Craig A. Collard, President and Chief Executive
Officer, annual base salary of $379,600; (ii) Chenyqua
Baldwin, Vice President, Finance, annual base salary of
$223,600; (iii) Brian Dickson, M.D., Chief Medical
Officer, annual base salary of $270,400; (iv) George Esgro,
Vice President, Sales and Marketing, annual base salary of
$220,000; (v) Steven M. Lutz, Executive Vice President,
Commercial Operations, annual base salary of $250,000; and (vi)
David Price, Executive Vice President, Finance, and Chief
Financial Officer, annual base salary of $285,000.
In addition to his employment agreement, Mr. Collard has
entered into an Executive Retention Agreement that provides for
certain severance benefits in the event that his employment is
terminated following a change in control of Cornerstone. The
material terms of this agreement have been summarized in the
section Narrative Disclosure to Summary Compensation Table
and Grants of Plan-Based Awards Table beginning on
page 312 of this proxy statement/prospectus.
Stockholder
Agreements
In connection with the execution of the merger agreement,
Mr. Collard, Ms. Baldwin, Dr. Dickson,
Mr. Esgro, Mr. Lutz, Mr. McEwan and other holders
of Cornerstone shares that in the aggregate hold approximately
81% of Cornerstones outstanding common stock entered into
agreements with Critical Therapeutics that provide, among other
things, that they will vote in favor of adoption of the merger
agreement and grant to Critical Therapeutics an irrevocable
proxy to vote all of their shares of Cornerstone common stock in
favor of adoption of the merger agreement and against any
proposal made in opposition to, or in competition with, the
proposal to adopt the merger agreement. In addition, subject to
certain exceptions, they have agreed not to transfer or
otherwise dispose of any shares of common stock of the combined
company or any securities convertible into or exercisable or
exchangeable for shares in the combined company for
180 days after the effective time of the merger.
Cornerstone
Stock Options and Warrants
Each outstanding option to purchase shares of Cornerstone common
stock, whether vested or unvested, and all stock option plans or
other stock or equity-related plans of Cornerstone themselves,
insofar as they relate to outstanding Cornerstones stock
options, will be assumed by Critical Therapeutics and will
become an option to acquire, on the same terms and conditions as
were applicable under such Cornerstone stock option immediately
prior to the effective time of the merger, such number of shares
of Critical Therapeutics common stock as is equal to the
number of shares of Cornerstone subject to the unexercised
portion of such Cornerstone stock option immediately prior to
the effective time of the merger multiplied by the exchange
ratio (rounded down to the nearest whole share number), at an
exercise price per share equal to the exercise price per share
of such Cornerstone stock option immediately prior to the
effective time of the merger divided by the exchange ratio
(rounded up to the nearest whole cent).
At the effective time of the merger, each warrant to purchase
shares of Cornerstone common stock outstanding immediately prior
to the effective time of the merger will be assumed by Critical
Therapeutics and will become a warrant to acquire, on the same
terms and conditions as were applicable under such Cornerstone
warrant, such number of shares of Critical Therapeutics
common stock as is equal to the number of shares of
Cornerstones common stock subject to the unexercised
portion of such Cornerstone warrant immediately prior to the
effective time of the merger multiplied by the exchange ratio
(rounded down to the nearest whole share number), at an exercise
price per share equal to the exercise price per share of such
Cornerstone warrant
128
immediately prior to the effective time of the merger divided by
the exchange ratio (rounded up to the nearest whole cent).
Form of
the Merger
Under the merger agreement, Cornerstone and the transitory
subsidiary will merge, with Cornerstone surviving as a wholly
owned subsidiary of Critical Therapeutics.
After completion of the merger, Critical Therapeutics will be
renamed Cornerstone Therapeutics Inc. and expects to
continue to trade on The NASDAQ Capital Market under the symbol
CRTX.
Following the merger, the headquarters of Critical Therapeutics
will be located in Cary, North Carolina, at Cornerstones
headquarters.
Merger
Consideration
At the effective time of the merger, all shares of Cornerstone
common stock outstanding immediately prior to the effective time
of the merger, including shares of Cornerstone common stock
issued or issuable to Carolina Pharmaceuticals for the exchange
or conversion of the outstanding principal amount of the
Carolina Note, will automatically be converted into the right to
receive shares of Critical Therapeutics common stock. In
addition, at the effective time of the merger, all options to
purchase shares of Cornerstone common stock outstanding
immediately prior to the effective time of the merger will be
assumed by Critical Therapeutics and will become options to
purchase shares of Critical Therapeutics common stock and
all warrants to purchase shares of Cornerstone common stock
outstanding immediately prior to the effective time of the
merger will be assumed by Critical Therapeutics and will become
warrants to purchase shares of Critical Therapeutics
common stock. The shares of Critical Therapeutics common
stock issued to Cornerstones stockholders in connection
with the merger are expected to represent approximately 70%, and
Critical Therapeutics current stockholders will own
approximately 30%, of the shares of Critical Therapeutics
common stock, assuming the exchange or conversion prior to the
merger of the outstanding principal amount of the Carolina Note
into shares of Cornerstones common stock and after giving
effect to shares issuable pursuant to Cornerstones
outstanding options and warrants, but without giving effect to
any shares issuable pursuant to Critical Therapeutics
outstanding options and warrants. The exact exchange ratio per
share of Cornerstones common stock will be based in part
on the number of shares of Cornerstones common stock
outstanding or issuable pursuant to outstanding options and
warrants immediately prior to the effective time of the merger
and will not be calculated until that time.
No certificate or scrip representing fractional shares of
Critical Therapeutics common stock will be issued in
connection with the merger. Each holder of Cornerstones
common stock who would otherwise have been entitled to receive a
fraction of a share of Critical Therapeutics common stock
(after taking into account all shares of Cornerstones
common stock represented by certificates delivered by such
holder) shall be entitled to receive, in lieu thereof, cash
(without interest) in an amount equal to such fractional part of
a share of Critical Therapeutics common stock multiplied
by the average last reported sales price of Critical
Therapeutics common stock at 4:00 p.m., Eastern time,
end of regular trading hours on NASDAQ during the 10 consecutive
trading days ending on the last trading day prior to the
effective date of the merger.
The merger agreement provides that, at the effective time of the
merger, Critical Therapeutics will deposit with BNY Mellon
Shareowner Services or another exchange agent designated by
Critical Therapeutics and reasonably acceptable to Cornerstone
stock certificates representing the shares of Critical
Therapeutics common stock issuable to Cornerstones
stockholders, a sufficient amount of cash to make payments in
lieu of fractional shares, and any dividend or distributions to
which holders of such stock certificates may be entitled.
The merger agreement provides that, as soon as reasonably
practicable after the effective time of the merger, the exchange
agent will mail to each record holder of Cornerstone common
stock immediately prior to the effective time of the merger a
letter of transmittal and instructions for surrendering and
exchanging the record holders Cornerstone stock
certificates. Upon surrender of a Cornerstone common stock
certificate for exchange to the exchange agent, together with a
duly signed letter of transmittal, and such other documents as
129
the exchange agent may reasonably require, the holder of the
Cornerstone stock certificate will be entitled to receive the
following:
|
|
|
|
|
a certificate representing the number of whole shares of
Critical Therapeutics common stock that such holder has
the right to receive pursuant to the provisions of the merger
agreement;
|
|
|
|
cash in lieu of any fractional share of Critical
Therapeutics common stock; and
|
|
|
|
dividends or other distributions, if any, to which they are
entitled under the terms of the merger agreement.
|
The Cornerstone stock certificate surrendered will be cancelled.
At the effective time of the merger, all holders of certificates
representing shares of Cornerstones common stock that were
outstanding immediately prior to the effective time of the
merger will cease to have any rights as stockholders of
Cornerstone. In addition, no transfer of Cornerstones
common stock after the effective time of the merger will be
registered on the stock transfer books of Cornerstone.
If any Cornerstone stock certificate has been lost, stolen or
destroyed, upon the making of an affidavit of that fact by the
person claiming such certificate to be lost, stolen or destroyed
and, if required by Critical Therapeutics, the posting by such
person of a bond in such reasonable amount as Critical
Therapeutics may direct as indemnity against any claim that may
be made against it with respect to such certificate, the
exchange agent shall issue in exchange for such lost, stolen or
destroyed certificate the shares of Critical Therapeutics
common stock, any cash in lieu of fractional shares, and any
unpaid dividends and distributions on such shares of Critical
Therapeutics common stock.
Effective
Time of the Merger
The merger agreement requires the parties to consummate the
merger after all of the conditions to the consummation of the
merger contained in the merger agreement are satisfied or
waived. The merger will become effective upon the filing of a
certificate of merger with the Secretary of State of the State
of Delaware or at such later time as is established by Critical
Therapeutics and Cornerstone and set forth in the certificate of
merger. However, neither Critical Therapeutics nor Cornerstone
can predict the exact timing of the consummation of the merger.
Regulatory
Approvals
Neither Critical Therapeutics nor Cornerstone is required to
make any filings or to obtain approvals or clearances from any
antitrust regulatory authorities in the United States or other
countries to consummate the merger. In the United States,
Critical Therapeutics must comply with applicable federal and
state securities laws and NASDAQ rules and regulations in
connection with the issuance of shares of Critical
Therapeutics common stock in the merger, including the
filing with the SEC of this proxy statement/prospectus. As of
the date hereof, the registration statement has not become
effective. Critical Therapeutics has filed an initial listing
application with The NASDAQ Capital Market pursuant to
NASDAQs reverse merger rules for the
re-listing of Critical Therapeutics common stock in
connection with the merger and to effect the initial listing of
Critical Therapeutics common stock issuable in connection
with the merger or upon exercise of Cornerstones
outstanding stock options or warrants.
Material
U.S. Federal Income Tax Consequences of the Merger
The following discussion summarizes the material
U.S. federal income tax consequences of the merger that are
expected to apply generally to Cornerstones stockholders
upon an exchange of their Cornerstone common stock for Critical
Therapeutics common stock in the merger. This summary is
based upon current provisions of the Code, existing Treasury
Regulations and current administrative rulings and court
decisions, all of which are subject to change and to differing
interpretations, possibly with retroactive effect.
130
This summary only applies to a Cornerstone stockholder that is a
U.S. person, defined to include:
|
|
|
|
|
a citizen or resident of the United States;
|
|
|
|
a corporation created or organized in or under the laws of the
United States, or any political subdivision thereof (including
the District of Columbia);
|
|
|
|
an estate the income of which is subject to U.S. federal
income taxation regardless of its source;
|
|
|
|
a trust if either:
|
|
|
|
|
|
a court within the United States is able to exercise primary
supervision over the administration of such trust and one or
more U.S. persons have the authority to control all
substantial decisions of such trust; or
|
|
|
|
|
|
the trust has a valid election in effect to be treated as a
U.S. person for U.S. federal income tax
purposes; and
|
|
|
|
|
|
any other person or entity that is treated for U.S. federal
income tax purposes as if it were one of the foregoing.
|
Any Cornerstone stockholder other than a
U.S. person as so defined is, for purposes of
this discussion, a
non-U.S. person.
If a partnership holds Cornerstone common stock, the tax
treatment of a partner will generally depend on the status of
the partner and the activities of the partnership. If you are a
partner of a partnership holding Cornerstone common stock, you
should consult your tax advisor.
This summary assumes that Cornerstones stockholders hold
their shares of Cornerstone common stock as capital assets
within the meaning of Section 1221 of the Code (generally,
property held for investment). No attempt has been made to
comment on all U.S. federal income tax consequences of the
merger that may be relevant to particular holders, including
holders:
|
|
|
|
|
who are subject to special treatment under U.S. federal
income tax rules such as dealers in securities, financial
institutions,
non-U.S. persons,
mutual funds, regulated investment companies, real estate
investment trusts, insurance companies, employees of Cornerstone
who will become employees of Critical Therapeutics, or
tax-exempt entities;
|
|
|
|
who are subject to the alternative minimum tax provisions of the
Code;
|
|
|
|
who acquired their shares in connection with stock option or
stock purchase plans or in other compensatory transactions;
|
|
|
|
who hold their shares as qualified small business stock within
the meaning of Section 1202 of the Code;
|
|
|
|
who hold their shares as part of an integrated investment such
as a hedge or as part of a hedging, straddle or other risk
reduction strategy; or
|
|
|
|
who do not hold their shares as capital assets.
|
In addition, the following discussion does not address the tax
consequences of the merger under state, local and foreign tax
laws or under the alternative minimum tax provisions of the
Code. Furthermore, the following discussion does not address any
of the:
|
|
|
|
|
tax consequences of transactions effectuated before, after or at
the same time as the merger, whether or not they are in
connection with the merger, including, without limitation,
transactions in which Cornerstone shares are acquired or
Critical Therapeutics shares are disposed of;
|
|
|
|
tax consequences of the receipt of Critical Therapeutics shares
other than in exchange for Cornerstone shares; or
|
|
|
|
tax implications of a failure of the merger to qualify as a
reorganization.
|
Accordingly, holders of Cornerstone common stock are advised
and expected to consult their own tax advisers regarding the
U.S. federal income tax consequences of the merger to them
in light of their personal circumstances and the consequences of
the merger under state, local and foreign tax laws.
131
As a condition to the consummation of the merger, WilmerHale and
Smith Anderson must render tax opinions that the merger will
constitute a reorganization within the meaning of
Section 368(a) of the Code, or a reorganization. The tax
opinions will be conditioned upon certain assumptions stated in
the tax opinions and will be based on the truth and accuracy, as
of the completion of the merger, of certain representations and
other statements made by Critical Therapeutics and Cornerstone
in certificates delivered to counsel. If any such
representations and other statements made in such certificates
are inaccurate, then the tax opinions may not be valid.
No ruling from the Internal Revenue Service, or IRS, has been or
will be requested in connection with the merger. In addition,
stockholders of Cornerstone should be aware that the tax
opinions discussed in this section are not binding on the IRS,
and the IRS could adopt a contrary position and a contrary
position could be sustained by a court.
It is intended that the merger will be treated for
U.S. federal income tax purposes as a reorganization within
the meaning of Section 368(a) of the Code. Accordingly, the
following material U.S. federal income tax consequences
will result:
|
|
|
|
|
Critical Therapeutics, the transitory subsidiary and Cornerstone
will not recognize any gain or loss solely as a result of the
merger;
|
|
|
|
stockholders of Cornerstone will not recognize any gain or loss
upon the receipt of Critical Therapeutics common stock in
exchange for their Cornerstone common stock, other than with
respect to cash received in lieu of fractional shares of
Critical Therapeutics common stock;
|
|
|
|
the aggregate tax basis of the shares of Critical
Therapeutics common stock received by a Cornerstone
stockholder in the merger (including any fractional share deemed
received) will be equal to the aggregate tax basis of the shares
of Cornerstone common stock surrendered in exchange therefor;
|
|
|
|
the holding period of the shares of Critical Therapeutics
common stock received by a Cornerstone stockholder in the merger
will include the holding period of the shares of Cornerstone
common stock surrendered in exchange therefor;
|
|
|
|
generally, cash payments received by Cornerstones
stockholders in lieu of fractional shares will be treated as if
such fractional shares of Critical Therapeutics common
stock were issued in the merger and then sold. A stockholder of
Cornerstone who receives such cash will recognize gain or loss
equal to the difference, if any, between such stockholders
basis in the fractional share and the amount of cash
received; and
|
|
|
|
such gain or loss will be a capital gain or loss, and generally
will constitute long-term capital gain or loss if the
stockholders holding period for the stock surrendered is
more than one year as of the closing date of the merger. Net
capital gain (i.e., the excess of net long-term capital
gain over net short-term capital loss) will be subject to tax at
reduced rates for non-corporate stockholders who receive cash.
The deductibility of capital losses is subject to various
limitations for corporate and non-corporate holders.
|
For purposes of the above discussion of the bases and holding
periods for shares of Cornerstones common stock and
Critical Therapeutics common stock, stockholders who
acquired different blocks of Cornerstone common stock at
different times for different prices must calculate their gains
and losses and holding periods separately for each identifiable
block of such stock exchanged, converted, cancelled, or received
in the merger.
The above discussion does not apply to Cornerstones
stockholders who properly perfect dissenters rights.
Generally, a Cornerstone stockholder who perfects
dissenters rights with respect to such stockholders
shares of Cornerstone common stock will recognize capital gain
or loss equal to the difference between such stockholders
tax basis in such shares and the amount of cash received in
exchange for such shares.
Certain noncorporate Cornerstone stockholders may be subject to
backup withholding, at a rate of 28% for 2008, on cash received
pursuant to the merger. Backup withholding will not apply,
however, to a Cornerstone stockholder who (1) furnishes a
correct taxpayer identification number and certifies that the
Cornerstone stockholder is not subject to backup withholding on
IRS
Form W-9
or a substantially similar form, (2) provides a
certification of foreign status on an appropriate
Form W-8
or successor form or (3) is otherwise exempt from backup
withholding. If a Cornerstone stockholder does not provide a
correct taxpayer
132
identification number on IRS
Form W-9
or a substantially similar form, the Cornerstone stockholder may
be subject to penalties imposed by the IRS. Amounts withheld, if
any, are generally not an additional tax and may be refunded or
credited against the Cornerstone stockholders federal
income tax liability, provided that the Cornerstone stockholder
furnishes the required information to the IRS.
THE PRECEDING DISCUSSION IS INTENDED ONLY AS A SUMMARY OF THE
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES OF THE MERGER
AND DOES NOT PURPORT TO BE A COMPLETE ANALYSIS OR DISCUSSION OF
ALL OF THE MERGERS POTENTIAL TAX EFFECTS. CORNERSTONE
STOCKHOLDERS ARE URGED TO CONSULT THEIR OWN TAX ADVISORS AS TO
THE SPECIFIC TAX CONSEQUENCES TO THEM OF THE MERGER, INCLUDING
TAX RETURN REPORTING REQUIREMENTS, AND THE APPLICABILITY AND
EFFECT OF FEDERAL, STATE, LOCAL AND OTHER APPLICABLE TAX
LAWS.
NASDAQ
Listing
Critical Therapeutics common stock is listed on The NASDAQ
Capital Market under the symbol CRTX.
On June 13, 2008, NASDAQ approved the transfer of the
listing of Critical Therapeutics common stock from The
NASDAQ Global Market to The NASDAQ Capital Market effective at
the opening of business on June 17, 2008. From July 2006 to
June 16, 2008, Critical Therapeutics common stock
traded on the NASDAQ Global Market. Prior to July 2006, Critical
Therapeutics common stock traded on The NASDAQ National
Market, the predecessor to The NASDAQ Global Market.
A condition to approval of the transfer of the listing of
Critical Therapeutics common stock to The NASDAQ Capital
Market was Critical Therapeutics satisfaction of The
NASDAQ Capital Markets continued listing requirements,
other than the $1.00 per share minimum bid price requirement.
Separately, if Critical Therapeutics meets all of The NASDAQ
Capital Markets initial listing requirements, other than
the minimum bid price requirement, on October 20, 2008,
which is the date that is 180 days following the date
Critical Therapeutics received notification from NASDAQ that it
failed to comply with the minimum bid price requirement,
Critical Therapeutics will have the remainder of an additional
180 calendar day grace period while listed on The NASDAQ Capital
Market to regain compliance with NASDAQs minimum bid price
requirement. There can be no assurance that on October 20,
2008 Critical Therapeutics will comply with The NASDAQ Capital
Markets initial listing requirements, including The NASDAQ
Capital Markets minimum stockholders equity
requirement.
On August 13, 2008, Critical Therapeutics received
notification from the NASDAQ Listing Qualification Department
that, based on its stockholders equity of
$1.2 million, as reported in its Quarterly Report on
Form 10-Q for the quarter ended June 30, 2008, and a market
value of its common stock as of August 12, 2008 of
$13.0 million, Critical Therapeutics does not comply with
NASDAQ Marketplace Rule 4310(c)(3), which requires it to
have, for continued listing on The NASDAQ Capital Market, a
minimum of $2.5 million in stockholders equity or
market value of listed securities of $35.0 million or
$500,000 of net income from continuing operations for the most
recently completed fiscal year or two of the three most recently
completed fiscal years. As a result, the Listing Qualifications
Staff is reviewing Critical Therapeutics eligibility for
continued listing on The NASDAQ Capital Market. To facilitate
the review, Critical Therapeutics provided to the Listing
Qualifications Staff on September 3, 2008 a definitive
plan, based on completing the proposed merger with Cornerstone,
to achieve and sustain compliance with all NASDAQ Capital
Market listing requirements. If after the conclusion of its
review process the Listing Qualifications Staff determines that
Critical Therapeutics plan does not adequately address the
deficiencies noted, the Staff will provide written notice to
Critical Therapeutics that its common stock will be delisted
from The NASDAQ Capital Market. In such event, Critical
Therapeutics may appeal the Staffs decision to a NASDAQ
Listing Qualifications Panel.
Critical Therapeutics has filed an initial listing application
with The NASDAQ Capital Market pursuant to NASDAQs
reverse merger rules for the re-listing of Critical
Therapeutics common stock in connection with the merger
and to effect the initial listing of Critical Therapeutics
common stock issuable in connection with the merger or upon
exercise of Cornerstones outstanding stock options or
warrants.
133
Anticipated
Accounting Treatment
The merger will be treated by Critical Therapeutics as a reverse
merger under the purchase method of accounting in accordance
with GAAP. For accounting purposes, Cornerstone is considered to
be acquiring Critical Therapeutics in this transaction.
Therefore, the aggregate consideration paid in connection with
the merger, together with the direct costs of acquisition, will
be allocated to Critical Therapeutics tangible and
intangible assets and liabilities based on their fair market
values. The assets and liabilities and results of operations of
Critical Therapeutics will be consolidated into the results of
operations of Cornerstone as of the effective time of the
merger. These allocations will be based upon a valuation that
has not yet been finalized.
Appraisal
Rights
If the merger is completed, Cornerstones stockholders are
entitled to appraisal rights under Section 262 of the
Delaware General Corporation Law, or Section 262, provided
that they comply with the conditions established by
Section 262. It is a condition to the obligation of
Critical Therapeutics and the transitory subsidiary to complete
the merger that holders of not more than 5% of
Cornerstones outstanding common stock exercise appraisal
rights.
The following is a summary of the material terms regarding a
Cornerstone stockholders appraisal rights under Delaware
law. It does not purport to be a complete discussion of all
aspects of a stockholders appraisal rights and is
qualified in its entirety by reference to the text of the
relevant provisions of Delaware law, which are attached to this
proxy statement/prospectus as Annex E.
Cornerstones stockholders intending to exercise appraisal
rights should carefully review Annex E. Failure to
follow precisely any of the statutory procedures set forth in
Annex E may result in a termination or waiver of
these rights.
A record holder of shares of Cornerstones common stock who
makes the demand described below with respect to such shares,
who continuously is the record holder of such shares through the
effective time of the merger, who otherwise complies with the
statutory requirements of Section 262 and who neither votes
in favor of the merger nor consents thereto in writing will be
entitled to an appraisal by the Delaware Court of Chancery, or
the Delaware Court, of the fair value of his, her or its shares
of Cornerstones common stock in lieu of the consideration
that such stockholder would otherwise be entitled to receive
pursuant to the merger agreement. All references in this summary
of appraisal rights to a stockholder or
holders of shares of Cornerstones common stock
are to the record holder or holders of shares of
Cornerstones common stock. Except as set forth herein,
Cornerstones stockholders will not be entitled to
appraisal rights in connection with the merger.
Under Section 262, where a merger is accomplished pursuant
to Section 228 of the Delaware General Corporation Law,
either a constituent corporation before the effective date of
the merger, or the surviving or resulting corporation within
10 days after the effective date of the merger, must notify
each stockholder of each constituent corporation entitled to
appraisal rights of the approval of the merger and that
appraisal rights are available to such stockholders and include
in each such notice a copy of Section 262. This proxy
statement/prospectus shall constitute such notice to the record
holders of Cornerstone common stock.
Cornerstones stockholders who desire to exercise their
appraisal rights must satisfy all of the conditions of
Section 262. Those conditions include the following:
|
|
|
|
|
Holders of shares of Cornerstone common stock who desire to
exercise their appraisal rights must, within 20 days after
the date of mailing of this notice, demand in writing the
appraisal of their shares.
|
|
|
|
The written demand for appraisal must be executed by or on
behalf of the stockholder of record and must reasonably inform
Cornerstone of the identity of the stockholder of record and
that such stockholder intends thereby to demand appraisal of
his, her or its Cornerstone common stock.
|
|
|
|
If the shares are owned of record by a person other than the
beneficial owner, including a broker, fiduciary (such as a
trustee, guardian or custodian), depositary or other nominee,
such demand must be executed by or for the record owner. If the
shares are owned by or for more than one person, as in a joint
|
134
|
|
|
|
|
tenancy or tenancy in common, such demand must be executed by or
for all joint owners. An authorized agent, including an agent
for two or more joint owners, may execute the demand for
appraisal for a stockholder of record. However, the agent must
identify the record owner and expressly disclose the fact that,
in exercising the demand, he is acting as agent for the record
owner. A person having a beneficial interest in
Cornerstones common stock held of record in the name of
another person, such as a broker or nominee, must act promptly
to cause the record holder to follow the steps summarized herein
in a timely manner to perfect whatever appraisal rights the
beneficial owner may have.
|
|
|
|
|
|
A stockholder who elects to exercise appraisal rights should
mail or deliver his, her or its written demand to Cornerstone at
Cornerstone BioPharma Holdings, Inc., 2000 Regency Parkway,
Suite 255, Cary, North Carolina 27518, Attention: Vice
President, Finance.
|
Within ten days after the effective time of the merger,
Cornerstone must provide notice of the effective time of the
merger to all Cornerstone stockholders who have complied with
Section 262 and have not voted in favor of the adoption of
the merger agreement.
Within 120 days after the effective time of the merger,
either Cornerstone or any stockholder who has complied with the
required conditions of Section 262 may commence an
appraisal proceeding by filing a petition in the Delaware Court,
with a copy served on Cornerstone in the case of a petition
filed by a stockholder, demanding a determination of the fair
value of the shares of all dissenting stockholders. There is no
present intent on the part of Cornerstone to file an appraisal
petition, and stockholders seeking to exercise appraisal rights
should not assume that Cornerstone will file such a petition or
that Cornerstone will initiate any negotiations with respect to
the fair value of such shares. Accordingly, holders of
Cornerstone capital stock who desire to have their shares
appraised should initiate any petitions necessary for the
perfection of their appraisal rights within the time periods and
in the manner prescribed in Section 262.
Within 120 days after the effective time of the merger, any
stockholder who has satisfied the requirements of
Section 262 will be entitled, upon written request, to
receive from Cornerstone a statement setting forth the aggregate
number of shares of Cornerstone common stock not voting in favor
of the adoption of the merger agreement and with respect to
which demands for appraisal were received by Cornerstone and the
aggregate number of holders of such shares. A person who is the
beneficial owner of shares of such stock held in a voting trust
or by a nominee on behalf of such person may, in such
persons own name, file a petition or request from the
corporation the statement described in the previous sentence.
Such statement must be mailed within 10 days after the
stockholders request has been received by Cornerstone or
within 10 days after the expiration of the period for the
delivery of demands as described above, whichever is later.
If a petition for an appraisal is timely filed and a copy
thereof is served upon Cornerstone, Cornerstone will then be
obligated, within 20 days after service, to file with the
Register in Chancery a duly verified list containing the names
and addresses of all stockholders who have demanded an appraisal
of their shares and with whom agreements as to the value of
their shares have not been reached. At the hearing on such
petition, the Delaware Court will determine which stockholders
are entitled to appraisal rights. The Delaware Court may require
the stockholders who have demanded an appraisal for their shares
and who hold stock represented by certificates to submit their
certificates of stock to the Register in Chancery for notation
thereon of the pendency of the appraisal proceedings; and if any
stockholder fails to comply with such direction, the Delaware
Court may dismiss the proceedings as to such stockholder. Where
proceedings are not dismissed, the appraisal proceeding shall be
conducted, as to the shares of Cornerstone capital stock owned
by such stockholders, in accordance with the rules of the
Delaware Court, including any rules specifically governing
appraisal proceedings. Through such proceeding the Delaware
Court shall determine the fair value of such shares exclusive of
any element of value arising from the accomplishment or
expectation of the merger, together with interest, if any, to be
paid upon the amount determined to be the fair value.
Although the board of directors of Cornerstone believes that the
merger consideration is fair, no representation is made as to
the outcome of the appraisal of fair value as determined by the
Delaware Court and stockholders should recognize that such an
appraisal could result in a determination of a value higher or
lower than, or the same as, the consideration they would receive
pursuant to the merger agreement. Moreover, Cornerstone does
135
not anticipate offering more than the merger consideration to
any stockholder exercising appraisal rights and reserves the
right to assert, in any appraisal proceeding, that, for purposes
of Section 262, the fair value of a share of
Cornerstone capital stock is less than the merger consideration.
In determining fair value, the Delaware Court is
required to take into account all relevant factors. In
Weinberger v. UOP, Inc., the Delaware Supreme Court
discussed the factors that could be considered in determining
fair value in an appraisal proceeding, stating that proof
of value by any techniques or methods which are generally
considered acceptable in the financial community and otherwise
admissible in court should be considered and that
[f]air price obviously requires consideration of all
relevant factors involving the value of a company. The
Delaware Supreme Court has stated that in making this
determination of fair value the court must consider market
value, asset value, dividends, earnings prospects, the nature of
the enterprise and any other facts which could be ascertained as
of the date of the merger which throw any light on future
prospects of the merged corporation. Section 262 provides
that fair value is to be exclusive of any element of value
arising from the accomplishment or expectation of the
merger. In Cede & Co. v. Technicolor,
Inc., the Delaware Supreme Court stated that such exclusion
is a narrow exclusion [that] does not encompass known
elements of value, but which rather applies only to the
speculative elements of value arising from such accomplishment
or expectation. In Weinberger, the Delaware Supreme Court
construed Section 262 to mean that elements of future
value, including the nature of the enterprise, which are known
or susceptible of proof as of the date of the merger and not the
product of speculation, may be considered.
The cost of the appraisal proceeding may be determined by the
Delaware Court and taxed against the parties as the Delaware
Court deems equitable in the circumstances. However, costs do
not include attorneys and expert witness fees. Each
dissenting stockholder is responsible for his or her
attorneys and expert witness expenses, although, upon
application of a dissenting stockholder, the Delaware Court may
order that all or a portion of the expenses incurred by any
dissenting stockholder in connection with the appraisal
proceeding, including without limitation, reasonable
attorneys fees and the fees and expenses of experts, be
charged pro rata against the value of all shares of stock
entitled to appraisal.
Any stockholder who has duly demanded appraisal in compliance
with Section 262 will not, after the effective time of the
merger, be entitled to vote for any purpose any shares subject
to such demand or to receive payment of dividends or other
distributions on such shares, except for dividends or
distributions payable to stockholders of record at a date prior
to the effective time of the merger.
At any time within 60 days after the effective time of the
merger, any stockholder who has not commenced an appraisal
proceeding or joined that proceeding as a named party will have
the right to withdraw his, her or its demand for appraisal and
to accept the terms offered in the merger agreement. After this
period, a stockholder may withdraw his, her or its demand for
appraisal and receive payment for his, her or its shares as
provided in the merger agreement only with the consent of
Cornerstone. If no petition for appraisal is filed with the
Delaware Court within 120 days after the effective time of
the merger, stockholders rights to appraisal will cease,
and all holders of shares of Cornerstone common stock will be
entitled to receive the consideration offered pursuant to the
merger agreement. Inasmuch as Cornerstone has no obligation to
file such a petition, and Cornerstone has no present intention
to do so, any stockholder who desires a petition to be filed is
advised to file it on a timely basis. Any stockholder may
withdraw such stockholders demand for appraisal by
delivering to Cornerstone a written withdrawal of his, her or
its demand for appraisal and acceptance of the merger
consideration, except (i) that any such attempt to withdraw
made more than 60 days after the effective time of the
merger will require written approval of Cornerstone and
(ii) that no appraisal proceeding in the Delaware Court
shall be dismissed as to any stockholder without the approval of
the Delaware Court, and such approval may be conditioned upon
such terms as the Delaware Court deems just, provided, however,
that this provision shall not affect the right of any
stockholder who has not commenced an appraisal proceeding or
joined that proceeding as a named party to withdraw such
stockholders demand for appraisal and to accept the terms
offered upon the merger within 60 days.
Failure by any Cornerstone stockholder to comply fully with the
procedures described above and set forth in Annex E
to this proxy statement/prospectus may result in termination
of such stockholders appraisal rights.
136
THE
MERGER AGREEMENT
The following is a summary of the material terms of the
merger agreement. A copy of the merger agreement is attached as
Annex A to this proxy statement/prospectus and is
incorporated by reference into this proxy statement/prospectus.
The merger agreement has been attached to this proxy
statement/prospectus to provide you with information regarding
its terms. It is not intended to provide any other factual
information about Critical Therapeutics, Cornerstone or the
transitory subsidiary. The following description does not
purport to be a complete discussion of all aspects of the merger
agreement and is qualified in its entirety by reference to the
merger agreement. You should refer to the full text of the
merger agreement for details of the merger and the terms and
conditions of the merger agreement.
General
Under the merger agreement, Cornerstone and the transitory
subsidiary, a wholly owned subsidiary of Critical Therapeutics
formed in connection with the merger, will merge, with
Cornerstone surviving as a wholly owned subsidiary of Critical
Therapeutics. After completion of the merger, Critical
Therapeutics will operate under the name Cornerstone
Therapeutics Inc. Immediately following the effective time
of the merger, Cornerstones stockholders will own
approximately 70%, and Critical Therapeutics current
stockholders will own approximately 30%, of Critical
Therapeutics common stock, assuming the exchange or
conversion prior to the merger of the outstanding principal
amount of the Carolina Note into shares of Cornerstones
common stock and after giving effect to shares issuable pursuant
to Cornerstones outstanding options and warrants, but
without giving effect to any shares issuable pursuant to
Critical Therapeutics outstanding options and warrants.
The closing of the merger will occur no later than the second
business day after the last of the conditions to the merger has
been satisfied or waived, or at another time as Cornerstone and
Critical Therapeutics agree. However, because the merger is
subject to a number of conditions, neither Critical Therapeutics
nor Cornerstone can predict exactly when the closing will occur
or if it will occur at all.
Merger
Consideration
At the effective time of the merger, each share of
Cornerstones common stock will be converted into and
exchanged for the right to receive a number of shares of
Critical Therapeutics common stock equal to the product of
2.3333 multiplied by the quotient of 43,479,198, which was the
number of outstanding shares of Critical Therapeutics
common stock on April 30, 2008, divided by the number of
shares of Cornerstones common stock outstanding
immediately prior to the effective time of the merger, assuming
the exercise or conversion of all outstanding Cornerstone
options and warrants, subject to adjustment for the reverse
stock split of Critical Therapeutics common stock.
Amendments
to Critical Therapeutics Certificate of
Incorporation
The merger agreement provides that Critical Therapeutics
stockholders must approve, as a condition to closing the merger,
an amendment to Critical Therapeutics certificate of
incorporation to effect a reverse stock split of Critical
Therapeutics common stock, which requires the affirmative
vote of holders of a majority of the outstanding common stock on
the record date for the special meeting. Upon the effectiveness
of the amendment to Critical Therapeutics certificate of
incorporation effecting the reverse stock split, the outstanding
shares of Critical Therapeutics common stock will be
reclassified and combined into a lesser number of shares such
that one share of Critical Therapeutics common stock will
be issued for a specified number of shares, which shall be
greater than one and equal to or less than 50, of outstanding
Critical Therapeutics common stock, with the exact number
within the range to be determined by Critical Therapeutics
board of directors prior to the effective time of such amendment
and publicly announced by Critical Therapeutics. As applicable
NASDAQ initial listing standards require Critical Therapeutics
to have, among other things, a $4.00 per share minimum
bid price, the reverse stock split is necessary in order to
consummate the merger.
137
Stockholders of record of Critical Therapeutics common
stock on the record date for the special meeting will also be
asked to approve an amendment to Critical Therapeutics
certificate of incorporation to change the name of the
corporation from Critical Therapeutics to Cornerstone
Therapeutics Inc. immediately following the consummation
of the merger.
Conditions
to the Completion of the Merger
Each partys obligation to complete the merger is subject
to the satisfaction or waiver by each of the parties, at or
prior to the merger, of various conditions, subject to specified
exceptions, which include the following:
|
|
|
|
|
the stockholders of Cornerstone must adopt the merger agreement,
and the stockholders of Critical Therapeutics must approve the
issuance of Critical Therapeutics common stock in the
merger and the amendment to Critical Therapeutics
certificate of incorporation to effect the reverse stock split
and change the name of Critical Therapeutics to
Cornerstone Therapeutics Inc.;
|
|
|
|
the waiting period (and any extensions thereof) applicable to
the consummation of the merger under the
Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as amended, and any other
applicable law shall have expired or been terminated;
|
|
|
|
all authorizations, consents, orders or approvals of, or
declarations or filings with, or expirations of waiting periods
imposed by, any governmental entity in connection with the
merger and the consummation of the other transactions
contemplated by the merger agreement have been filed, been
obtained or occurred;
|
|
|
|
the registration statement on
Form S-4,
of which this proxy statement/prospectus is a part, must have
become effective under the Securities Act, no stop order
suspending the effectiveness of the
Form S-4
shall have been issued, and no proceeding for that purpose shall
have been initiated or threatened in writing by the SEC;
|
|
|
|
there must not have been issued any order, executive order,
stay, decree, judgment or injunction (preliminary or permanent)
or statute, rule or regulation which is in effect and which has
the effect of making the consummation of the merger illegal or
otherwise prohibiting consummation of the merger or the other
transactions contemplated by the merger agreement; and
|
|
|
|
there shall not be instituted or pending any action or
proceeding by any governmental entity seeking to restrain,
prohibit or otherwise interfere with the ownership or operation
by Critical Therapeutics of Cornerstone or to compel Critical
Therapeutics to dispose of or hold separate all or any portion
of Cornerstones business or assets or Critical
Therapeutics business or assets, seeking to impose or
confirm limitations on the ability of Critical Therapeutics
effectively to exercise full rights of ownership of the shares
of Cornerstone common stock or seeking to require divestiture by
Critical Therapeutics of any shares of Cornerstone common stock.
|
In addition, each partys obligation to complete the merger
is further subject to the satisfaction or waiver by that party
of the following additional conditions:
|
|
|
|
|
all representations and warranties of the other party in the
merger agreement being true and correct on the date of the
merger agreement and on the closing date of the merger, as if
made on the closing date of the merger or, if such
representations and warranties address matters as of a specific
date, then as of that specific date, except, other than with
respect to representations about such partys
capitalization and required approvals of the merger agreement
and related transactions, where the failure of these
representations and warranties to be true and correct,
disregarding any materiality qualifications, individually or in
the aggregate, has not had and is not reasonably likely to have
a material adverse effect on the party making the
representations and warranties;
|
|
|
|
the other party to the merger agreement having performed in all
material respects all obligations required to be performed by it
on or before the closing of the merger;
|
138
|
|
|
|
|
the other party having delivered the documents required under
the merger agreement for the closing of the merger, including
identified third party consents and certificates from specified
officers;
|
|
|
|
no material adverse effect having occurred since the date of the
merger agreement and be continuing with respect to the other
party; and
|
|
|
|
the receipt of a written opinion from such partys tax
counsel to the effect that the merger will be treated for
U.S. federal income tax purposes as a reorganization within
the meaning of Section 368(a) of the Code; provided that if
a partys tax counsel does not render such an opinion, this
condition will nonetheless be deemed satisfied if tax counsel
for the other party renders such an opinion.
|
In addition, the obligation of Critical Therapeutics and the
transitory subsidiary to complete the merger is further subject
to the satisfaction or waiver of the following conditions:
|
|
|
|
|
the number of shares of Cornerstone common stock held as of the
effective time of the merger that have not been voted in favor
of the adoption of the merger agreement and with respect to
which appraisal shall have been duly demanded and perfected in
accordance with Delaware law shall not exceed 5% of the number
of outstanding shares of Cornerstones common stock as of
the effective time of the merger;
|
|
|
|
the exchange or conversion of the outstanding principal amount
under the Carolina Note for shares of Cornerstones common
stock; and
|
|
|
|
the delivery of fully executed copies of the voting agreements
of Cornerstones stockholders and noteholders.
|
In addition, the obligation of Cornerstone to complete the
merger is further subject to the satisfaction or waiver of the
following conditions:
|
|
|
|
|
the delivery of fully executed copies of the stockholder
agreements of Critical Therapeutics stockholders;
|
|
|
|
NASDAQ shall have approved Critical Therapeutics
application for initial inclusion on The NASDAQ Capital Market
in connection with the listing of Critical Therapeutics
common stock and the listing of shares of Critical Therapeutics
issuable in connection with the merger or upon exercise of
Cornerstone options and warrants; and
|
|
|
|
the availability of either ZYFLO CR or ZYFLO for purchase by
third party wholesalers or retailers at all times from the date
of the merger agreement through the closing of the merger, other
than during any period that has not exceeded, and, as of the
closing date of the merger, is not reasonably expected to
exceed, 30 consecutive days.
|
A material adverse effect, with respect to a party,
means any material adverse change, event, circumstance or
development with respect to, or material adverse effect on,
(i) the business, assets, liabilities, condition (financial
or other), or results of operations of a party and its
subsidiaries, taken as a whole, or (ii) the ability of a
party and its subsidiaries to consummate the transactions
contemplated by the merger agreement; provided, however, that
any change or event caused by or resulting from the following
shall not be deemed to be a material adverse effect (but, in the
case of the first four bullets below, only to the extent that
they do not have a materially disproportionate adverse effect on
the party and its subsidiaries relative to other participants in
the industries or markets in which they operate):
|
|
|
|
|
changes in prevailing economic or market conditions in the
United States or any other jurisdiction in which a party and its
subsidiaries have substantial business operations;
|
|
|
|
changes or events, after the date of the merger agreement,
affecting the industries in which a party and its subsidiaries
operate generally;
|
|
|
|
changes, after the date of the merger agreement, in generally
accepted accounting principles or requirements applicable to the
party and its subsidiaries;
|
139
|
|
|
|
|
changes, after the date of the merger agreement, in laws, rules
or regulations of general applicability or interpretations
thereof by any court or governmental or regulatory authority;
|
|
|
|
the execution, delivery and performance of the merger agreement
or the consummation of the transactions contemplated by the
merger agreement or the announcement thereof;
|
|
|
|
any outbreak of major hostilities in which the United States is
involved or any act of terrorism within the United States or
directed against the facilities or citizens of the United States
wherever located;
|
|
|
|
with respect to Critical Therapeutics, any issues or disruptions
related to the manufacture of ZYFLO CR and its supply chain
arising in connection with Critical Therapeutics
investigation of certain batches of ZYFLO CR that are on a
Quality Assurance Hold or failed to meet
specifications;
|
|
|
|
with respect to Critical Therapeutics, the results of
Mylans strategic alternatives process for DEY and any
impact on Critical Therapeutics co-promotion agreements
with DEY; or
|
|
|
|
with respect to Critical Therapeutics, specified ordinary course
operational exceptions as set forth in Critical
Therapeutics disclosure schedule to the merger agreement.
|
No
Solicitation
Each of Cornerstone and Critical Therapeutics agreed that,
except as described below, neither Cornerstone nor Critical
Therapeutics shall, nor shall either of them authorize or permit
any of their or their respective subsidiaries subsidiaries
or any of their or their subsidiaries respective
directors, officers, employees, investment bankers, attorneys,
accountants or other advisors or representatives to, directly or
indirectly:
|
|
|
|
|
solicit, initiate, encourage or take any other action designed
to facilitate any inquiries or the making of any proposal or
offer that constitutes, or could reasonably be expected to lead
to, any acquisition proposal, as defined
below; or
|
|
|
|
enter into, continue or otherwise participate in any discussions
or negotiations regarding, furnish to any person any information
with respect to, assist or participate in any effort or attempt
by any person with respect to, or otherwise cooperate in any way
with, any acquisition proposal.
|
An acquisition proposal means, with respect to any
party, any inquiry, proposal or offer from any person relating
to, in a single transaction or series of related transactions,
any (i) acquisition of assets of such party and its
subsidiaries, excluding sales of assets in the ordinary course
of business consistent with past practice, equal to 10% or more
of such partys consolidated assets or to which 10% or more
of such partys revenues or earnings on a consolidated
basis are attributable, (ii) acquisition of 10% or more of
such partys outstanding common stock, (iii) tender
offer or exchange offer that if consummated would result in any
person beneficially owning 10% or more of such partys
outstanding common stock, (iv) merger, consolidation, share
exchange, business combination, recapitalization, liquidation,
dissolution or similar transaction involving such party or any
of its subsidiaries or (v) any combination of the foregoing
types of transactions if the sum of the percentage of
consolidated assets, consolidated revenues or earnings and
common stock involved is 10% or more, in each case, other than
the merger.
However, if at any time prior to the approval of the issuance of
the shares of Critical Therapeutics common stock in the
merger at the special meeting, Critical Therapeutics receives a
written acquisition proposal from any person or group of persons
that did not result from a breach of Critical Therapeutics
obligations described above, (i) Critical Therapeutics may
contact such person or group of persons to clarify the terms and
conditions thereof and (ii) if Critical Therapeutics
board of directors, or any committee thereof, determines in good
faith, after consultation with outside legal counsel and a
nationally recognized financial advisor, that such acquisition
proposal constitutes or could reasonably be expected to lead to
a superior proposal, as defined below, then Critical
Therapeutics and its representatives may, subject to compliance
with the merger agreement (x) furnish information with
respect to Critical Therapeutics to the person making such
acquisition proposal and its representatives pursuant to a
customary confidentiality agreement not less restrictive of the
other party than the confidentiality agreement entered into
between Critical Therapeutics and Cornerstone and
140
(y) participate in discussions or negotiations with such
person and its representatives regarding any superior proposal.
A superior proposal means, with respect to Critical
Therapeutics, any unsolicited, bona fide written acquisition
proposal on terms that Critical Therapeutics board of
directors determines in its good faith judgment to be
(i) materially more favorable to the stockholders of
Critical Therapeutics than the transactions contemplated by the
merger agreement, taking into account all the terms and
conditions of such proposal (including the likelihood and timing
of consummation thereof) and the merger agreement (including any
written proposal by either party to amend the terms of the
merger agreement in response to such acquisition proposal or
otherwise) and after consultation with outside legal counsel and
a nationally recognized financial advisor, and
(ii) reasonably capable of being completed on the terms
proposed, taking into account all financial, regulatory, legal
and other aspects of such proposal; provided, however, that no
acquisition proposal shall be deemed to be a superior proposal
if any financing required to consummate the acquisition proposal
is not fully and irrevocably committed; and provided, further,
that for purposes of the definition of superior
proposal, the references to 10% in the
definition of acquisition proposal shall be deemed to be
references to 50%.
Change in
Recommendation
The merger agreement provides that neither Critical
Therapeutics board of directors nor Cornerstones
board of directors shall (i) except in the manner permitted
with respect to an acquisition proposal, withdraw or modify, or
publicly propose to withdraw or modify, in a manner adverse to
the other party, its approval or recommendation with respect to
the Critical Therapeutics proposals to issue shares of common
stock in connection with the merger, effect the reverse stock
split and change the name of Critical Therapeutics to
Cornerstone Therapeutics Inc. or the adoption of the
merger agreement by Cornerstones stockholders, as the case
may be; (ii) cause or permit such party to enter into any
letter of intent, memorandum of understanding, agreement in
principle, acquisition agreement, merger agreement or similar
agreement constituting or relating to any acquisition proposal,
other than, with respect to Critical Therapeutics, a
confidentiality agreement entered into in the circumstances
permitted by the merger agreement; or (iii) adopt, approve
or recommend, or propose to adopt, approve or recommend, any
acquisition proposal.
Notwithstanding the foregoing, Critical Therapeutics board
of directors may withdraw or modify its recommendation with
respect to its proposals to issue shares of common stock in
connection with the merger, effect the reverse stock split and
change the name of Critical Therapeutics to Cornerstone
Therapeutics Inc. if Critical Therapeutics board of
directors determines in good faith after consultation with
outside counsel that its fiduciary obligations require it to do
so, but only at a time that is prior to the approval of the
issuance of shares of Critical Therapeutics common stock
at the special meeting and after the fifth business day
following receipt by Cornerstone of written notice advising it
that Critical Therapeutics board of directors desires to
withdraw or modify the recommendation and, if such withdrawal is
due to the existence of an acquisition proposal, specifying the
material terms and conditions of such acquisition proposal and
identifying the person making such acquisition proposal.
Meeting
of Critical Therapeutics Stockholders
Critical Therapeutics is obligated under the merger agreement to
call, give notice of and hold the special meeting for purposes
of approving the issuance of shares of Critical
Therapeutics common stock in the merger, approving the
amendment to Critical Therapeutics certificate of
incorporation to effect the reverse stock split and the
amendment to Critical Therapeutics certificate of
incorporation to change the name of Critical Therapeutics to
Cornerstone Therapeutics Inc.
The obligation to call, give notice of and hold the special
meeting remains applicable even if Critical Therapeutics accepts
or recommends a superior proposal, unless Cornerstone terminates
the merger agreement.
141
Covenants;
Conduct of Business Pending the Merger
Cornerstone agreed that it will, and will cause each of its
subsidiaries to, act and carry on its business in the usual,
regular and ordinary course in substantially the same manner as
previously conducted, pay its debts and taxes and perform its
other obligations when due, comply with applicable laws, rules
and regulations, and use commercially reasonable efforts,
consistent with past practices, to maintain and preserve its and
each of its subsidiaries business organization, assets and
properties, keep available the services of its present officers
and key employees and preserve its advantageous business
relationships with customers, strategic partners, suppliers,
distributors and others having business dealings with it.
Cornerstone also specifically agreed that, subject to specified
exceptions, without the consent of Critical Therapeutics, it
would not, during the period prior to the effective time of the
merger:
|
|
|
|
|
declare, set aside or pay any dividends or make any other
distributions in respect of any shares of its capital stock or
repurchase any securities (other than dividends and
distributions by a direct or indirect wholly owned subsidiary of
Cornerstone), split, combine or reclassify its capital stock or
purchase, redeem or otherwise acquire shares of its capital
stock or any rights, warrants or options other than from former
employees, directors and consultants;
|
|
|
|
issue, deliver, sell, grant, pledge or otherwise dispose of or
encumber any securities, including options and warrants, other
than the issuance of shares of Cornerstone common stock upon the
exercise of options and warrants;
|
|
|
|
amend its certificate of incorporation, bylaws or other
comparable charter or organizational documents;
|
|
|
|
except for purchases of inventory in the ordinary course of
business consistent with past practice, acquire (i) by
merging or consolidating with, or by purchasing all or a
substantial portion of the assets or any stock of, or by any
other manner, any business or any corporation, partnership,
joint venture, limited liability company, association or other
business organization or division thereof or (ii) any
assets that are material, in the aggregate, to Cornerstone and
its subsidiaries, taken as a whole;
|
|
|
|
except in the ordinary course of business consistent with past
practice, sell, lease, license, pledge, or otherwise dispose of
or encumber any properties or assets of Cornerstone or of any of
its subsidiaries;
|
|
|
|
sell, dispose of or otherwise transfer any assets material to
Cornerstone and its subsidiaries;
|
|
|
|
adopt or implement any stockholder rights plan;
|
|
|
|
enter into an agreement with respect to any merger,
consolidation, liquidation or business combination, or any
acquisition or disposition of all or substantially all of the
assets or securities of Cornerstone or any of its subsidiaries;
|
|
|
|
(i) incur or permit to exist any indebtedness other than
indebtedness that existed as of December 31, 2007 as
reflected on Cornerstones balance sheet or pursuant to
Cornerstones $4.0 million line of credit with Paragon
Commercial Bank in the ordinary course of business consistent
with past practice or guarantee any such indebtedness of another
person, (ii) issue, sell or amend any debt securities or
warrants or other rights to acquire any debt securities of
Cornerstone or any of its subsidiaries, guarantee any debt
securities of another person, enter into any keep
well or other agreement to maintain any financial
statement condition of another person or enter into any
arrangement having the economic effect of any of the foregoing,
(iii) make any loans, advances (other than routine advances
to employees of Cornerstone in the ordinary course of business
consistent with past practice) or capital contributions to, or
investment in, any other person, other than Cornerstone or any
of its direct or indirect wholly owned subsidiaries or
(iv) enter into any hedging agreement or other financial
agreement or arrangement designed to protect Cornerstone or its
subsidiaries against fluctuations in commodities prices or
exchange rates;
|
|
|
|
make any capital expenditures or other expenditures with respect
to property, plant or equipment in excess of $50,000 in the
aggregate for Cornerstone and its subsidiaries;
|
142
|
|
|
|
|
make any changes in accounting methods, principles or practices,
except insofar as may have been required by the SEC or a change
in GAAP, or, except as so required, change any assumption
underlying, or method of calculating, any bad debt, contingency
or other reserve;
|
|
|
|
modify, amend or terminate any material contract or agreement to
which Cornerstone or any of its subsidiaries is party, or
knowingly waive, release or assign any material rights or
claims, except in the ordinary course of business consistent
with past practice or, to the extent subject to reserves
reflected on Cornerstones balance sheet as of
December 31, 2007, in accordance with GAAP;
|
|
|
|
(i) except in the ordinary course of business consistent
with past practice, enter into any material contract or
agreement relating to the rendering of services or the
distribution, sale or marketing by third parties of the products
of, or products licensed by, Cornerstone or any of its
subsidiaries or (ii) license any material intellectual
property to or from any third party;
|
|
|
|
except as required to comply with applicable law or agreements,
plans or arrangements existing on the date of the merger
agreement, (i) take any action with respect to, adopt,
enter into, terminate or amend any employment, severance or
similar agreement or benefit plan for the benefit or welfare of
any current or former director, officer, employee or consultant
or any collective bargaining agreement, (ii) increase in
any material respect the compensation or fringe benefits of, or
pay any bonus to, any director, officer, employee or consultant
(except for annual increases of the salaries of non-officer
employees in the ordinary course), (iii) amend or
accelerate the payment, right to payment or vesting of any
compensation or benefits, including any outstanding Cornerstone
stock options or restricted stock awards, (iv) pay any
material benefit not provided for as of the date of the merger
agreement under any benefit plan, (v) grant any awards under any
bonus, incentive, performance or other compensation plan or
arrangement or benefit plan (including the grant of stock
options, stock appreciation rights, stock based or stock related
awards, performance units or restricted stock, or the removal of
existing restrictions in any benefit plans or agreements or
awards made thereunder), except for the grant of options to
purchase Cornerstone common stock to new hires, which grants
shall not exceed 100,000 shares in the aggregate and
5,000 shares to any one person, and which option grants
shall have an exercise price equal to the fair market value of
Cornerstone common stock on the date of grant (determined in a
manner consistent with Cornerstones existing practice for
establishing fair market value for option grants and which
option grants shall otherwise be upon Cornerstones
customary terms) or (vi) take any action other than in the
ordinary course of business consistent with past practice to
fund or in any other way secure the payment of compensation or
benefits under any employee plan, agreement, contract or
arrangement or benefit plan;
|
|
|
|
make or rescind any material tax election, settle or compromise
any material tax liability or amend any tax return except as
required by applicable law;
|
|
|
|
commence any offering of shares of Cornerstone common stock
pursuant to any employee stock purchase plan, permit any
employee to enroll in any employee stock purchase plan or allow
any participant in an employee stock purchase plan to increase
the current level of such participants payroll deductions
thereunder;
|
|
|
|
initiate, compromise or settle any material litigation or
arbitration proceeding;
|
|
|
|
open or close any facility or office;
|
|
|
|
fail to use commercially reasonable efforts to maintain
insurance at levels substantially comparable to levels existing
as of the date of the merger agreement;
|
|
|
|
fail to pay accounts payable and other obligations in the
ordinary course of business consistent with past practice;
|
|
|
|
fail to use commercially reasonable efforts to maintain
inventory levels in the sales channel to ensure product
availability to meet expected patient demand; provided, however,
that the inventory level of any individual product in the sales
channel shall not exceed the aggregate sales for the preceding
three
|
143
|
|
|
|
|
months for such product, as measured by industry standard third
party data sources, such as IMS Health, National Prescription
Audit or the like; or
|
|
|
|
|
|
agree or commit to take any of these restricted actions.
|
Critical Therapeutics agreed that it will, and will cause each
of its subsidiaries to, act and carry on its business in the
usual, regular and ordinary course in substantially the same
manner as previously conducted, pay its debts and taxes and
perform its other obligations when due, comply with applicable
laws, rules and regulations, and use commercially reasonable
efforts, consistent with past practices, to maintain and
preserve its and each of its subsidiaries business
organization, assets and properties, keep available the services
of its present officers and key employees and preserve its
advantageous business relationships with customers, strategic
partners, suppliers, distributors and others having business
dealings with it. Critical Therapeutics also specifically agreed
that, subject to limited exceptions, without the consent of
Cornerstone, it would not, during the period prior to the
effective time of the merger:
|
|
|
|
|
declare, set aside or pay any dividends or make any other
distributions in respect of any shares of its capital stock or
repurchase any securities (other than dividends and
distributions by a direct or indirect wholly owned subsidiary of
Critical Therapeutics), with the exception of the reverse stock
split, split, combine or reclassify its capital stock or
purchase, redeem or otherwise acquire shares of its capital
stock or any rights, warrants or options other than from former
employees, directors and consultants;
|
|
|
|
issue, deliver, sell, grant, pledge or otherwise dispose of or
encumber any securities, including options and warrants, other
than the issuance of shares of Critical Therapeutics
common stock upon exercise of options and warrants;
|
|
|
|
amend its certificate of incorporation, bylaws or other
comparable charter or organizational documents, except to the
extent necessary to carry into effect the reverse stock split
and the change of the name of Critical Therapeutics to
Cornerstone Therapeutics Inc.;
|
|
|
|
except for purchases of inventory in the ordinary course of
business consistent with past practice, acquire (i) by
merging or consolidating with, or by purchasing all or a
substantial portion of the assets or any stock of, or by any
other manner, any business or any corporation, partnership,
joint venture, limited liability company, association or other
business organization or division thereof or (ii) any
assets that are material, in the aggregate, to Critical
Therapeutics and its subsidiaries, taken as a whole;
|
|
|
|
except in the ordinary course of business consistent with past
practice, sell, lease, license, pledge, or otherwise dispose of
or encumber any properties or assets;
|
|
|
|
sell, dispose of or otherwise transfer any assets material to
Critical Therapeutics;
|
|
|
|
adopt or implement any stockholder rights plan;
|
|
|
|
except for a confidentiality agreement as permitted in
connection with an acquisition proposal, enter into an agreement
with respect to any merger, consolidation, liquidation or
business combination, or any acquisition or disposition of all
or substantially all of the assets or securities of Critical
Therapeutics;
|
|
|
|
(i) incur or permit to exist any indebtedness for borrowed
money or guarantee any such indebtedness of another person,
(ii) issue, sell or amend any debt securities or warrants
or other rights to acquire any debt securities of Critical
Therapeutics, guarantee any debt securities of another person,
enter into any keep well or other agreement to
maintain any financial statement condition of another person or
enter into any arrangement having the economic effect of any of
the foregoing, (iii) make any loans, advances (other than
routine advances to employees of Critical Therapeutics in the
ordinary course of business consistent with past practice) or
capital contributions to, or investment in, any other person,
other than Critical Therapeutics or any of its direct or
indirect wholly owned subsidiaries or (iv) enter into any
hedging agreement or other financial agreement or arrangement
designed to protect Critical Therapeutics or its subsidiaries
against fluctuations in commodities prices or exchange rates;
|
144
|
|
|
|
|
make any capital expenditures or other expenditures with respect
to property, plant or equipment in excess of $50,000 in the
aggregate for Critical Therapeutics and its subsidiaries, taken
as a whole, other than as set forth in Critical
Therapeutics budget for capital expenditures made
available to Cornerstone or specific capital expenditures
disclosed and set forth on Critical Therapeutics
disclosure schedule;
|
|
|
|
make any changes in accounting methods, principles or practices,
except insofar as may have been required by the SEC or a change
in GAAP or, except as so required, change any assumption
underlying, or method of calculating, any bad debt, contingency
or other reserve;
|
|
|
|
modify, amend or terminate any material contract or agreement to
which Critical Therapeutics is party, or knowingly waive,
release or assign any material rights or claims (including any
write-off or other compromise of any accounts receivable of
Critical Therapeutics or any of its subsidiaries), except in the
ordinary course of business consistent with past practice or, to
the extent subject to reserves reflected on the Critical
Therapeutics balance sheet as of December 31, 2007,
in accordance with GAAP;
|
|
|
|
(i) except in the ordinary course of business consistent
with past practice, enter into any material contract or
agreement relating to the rendering of services or the
distribution, sale or marketing by third parties of the products
of, or products licensed by, Critical Therapeutics or
(ii) license any material intellectual property to or from
any third party;
|
|
|
|
except as required to comply with applicable law or agreements,
plans or arrangements existing on the date of the merger
agreement, (i) take any action with respect to, adopt,
enter into, terminate or amend any employment, severance or
similar agreement or benefit plan for the benefit or welfare of
any current or former director, officer, employee or consultant
or any collective bargaining agreement, (ii) increase in
any material respect the compensation or fringe benefits of, or
pay any bonus to, any director, officer, employee or consultant
(except for annual increases of the salaries of non-officer
employees in the ordinary course), (iii) amend or
accelerate the payment, right to payment or vesting of any
compensation or benefits, including any outstanding Critical
Therapeutics stock option or restricted stock awards,
(iv) pay any material benefit not provided for as of the
date of the merger agreement under any benefit plan,
(v) grant any awards under any bonus, incentive,
performance or other compensation plan or arrangement or benefit
plan (including the grant of stock options, stock appreciation
rights, stock based or stock related awards, performance units
or restricted stock, or the removal of existing restrictions in
any benefit plans or agreements or awards made thereunder),
except for the grant of options to purchase Critical
Therapeutics common stock to new hires, which grants shall
not exceed 100,000 shares in the aggregate and
5,000 shares to any one person, and which option grants
shall have an exercise price equal to the fair market value of
Critical Therapeutics common stock on the date of grant
(determined in a manner consistent with Critical
Therapeutics existing practice for establishing fair
market value for option grants and which option grants shall
otherwise be upon Critical Therapeutics customary terms)
or (vi) take any action other than in the ordinary course
of business consistent with past practice to fund or in any
other way secure the payment of compensation or benefits under
any employee plan, agreement, contract or arrangement or benefit
plan;
|
|
|
|
make or rescind any material tax election, settle or compromise
any material tax liability or amend any tax return except as
required by applicable law;
|
|
|
|
commence any offering of shares of Critical Therapeutics
common stock pursuant to any employee stock purchase plan,
permit any employee to enroll in any employee stock purchase
plan or allow any participant in an employee stock purchase plan
to increase the current level of such participants payroll
deductions thereunder;
|
|
|
|
initiate, compromise or settle any material litigation or
arbitration proceeding;
|
|
|
|
open or close any facility or office;
|
|
|
|
fail to use commercially reasonable efforts to maintain
insurance at levels substantially comparable to levels existing
as of the date of the merger agreement;
|
145
|
|
|
|
|
fail to pay accounts payable and other obligations in the
ordinary course of business consistent with past practice;
|
|
|
|
fail to use commercially reasonable efforts to maintain
inventory levels in the sales channel to ensure product
availability to meet expected patient demand; provided, however,
that the inventory level of any individual product in the sales
channel shall not exceed the aggregate sales for the preceding
three months for such product, as measured by industry standard
third party data sources, such as IMS Health, National
Prescription Audit or the like;
|
|
|
|
fail to appropriately adjust any Critical Therapeutics stock
options or warrants so that the exercise prices and number of
shares issuable upon exercise provide the holder the same
economic benefit as existed immediately prior to the reverse
stock split; or
|
|
|
|
agree or commit to take any of these restricted actions.
|
Other
Agreements
Each of Cornerstone and Critical Therapeutics has agreed to use
its commercially reasonable efforts to:
|
|
|
|
|
take all actions necessary to complete the merger;
|
|
|
|
promptly file or otherwise submit all applications, notices,
reports and other documents reasonably required to be filed with
a governmental entity with respect to the merger;
|
|
|
|
obtain any approvals under applicable antitrust laws and lift
any injunction prohibiting the merger or other transactions
contemplated by the merger agreement under antitrust laws;
|
|
|
|
obtain all consents, approvals or waivers reasonably required in
connection with the transactions contemplated by the merger
agreement;
|
|
|
|
consult and agree with each other about any public statement or
press release either will make concerning the merger; and
|
|
|
|
cause the merger to qualify as a reorganization within the
meaning of Section 368(a) of the Code.
|
Cornerstone and Critical Therapeutics also have agreed:
|
|
|
|
|
that Critical Therapeutics will, in consultation with
Cornerstone, file an application for initial inclusion on The
NASDAQ Capital Market in connection with the listing of Critical
Therapeutics common stock in connection with NASDAQs
reverse merger rules and to effect the listing of
Critical Therapeutics common stock issuable in connection
with the merger or upon exercise of Cornerstones
outstanding stock options or warrants;
|
|
|
|
to provide reasonable access to information to the other party
and to coordinate with the other in preparing and exchanging
information and to promptly provide the other with copies of all
filings or submissions made in connection with the merger;
|
|
|
|
that for a period of six years after the merger, the combined
company will indemnify each of the directors and officers of
Critical Therapeutics to the fullest extent permitted by law and
will maintain directors and officers liability
insurance for Critical Therapeutics directors and officers;
|
|
|
|
to use reasonable efforts to consult and agree with each other
about any statement or materials sent to employees; and
|
|
|
|
to notify the other party of any event, the occurrence of which
would be reasonably likely to cause a representation or warranty
in the merger agreement to be inaccurate or untrue or any
material failure of a party to comply with or satisfy a covenant
or condition in the merger agreement.
|
146
Termination
The merger agreement may be terminated at any time before the
completion of the merger, whether before or after the required
Cornerstone stockholder approval of the merger has been
obtained, as set forth below:
|
|
|
|
|
by mutual written consent of Cornerstone and Critical
Therapeutics;
|
|
|
|
by either Cornerstone or Critical Therapeutics if the merger has
not been completed by November 30, 2008, but this right to
terminate the merger agreement will not be available to any
party whose failure to fulfill any obligation under the merger
agreement has been a principal cause of or resulted in the
failure of the merger to be completed by such date;
|
|
|
|
by either Cornerstone or Critical Therapeutics if a governmental
entity has issued a nonappealable final order, decree or ruling
or taken any other nonappealable final action that permanently
restrains, enjoins or otherwise prohibits the merger;
|
|
|
|
by either Cornerstone or Critical Therapeutics if Critical
Therapeutics stockholders do not approve each of the
proposals presented at the special meeting at which a vote on
such proposals is taken, but this right to terminate the merger
agreement will not be available (i) to a party if such
party is in breach of or has failed to fulfill its obligations
under the merger agreement or (ii) to Critical Therapeutics
if the failure to obtain the requisite vote was caused by a
breach by any party other than Cornerstone of the stockholder
agreements entered into with Critical Therapeutics
stockholders in connection with the merger;
|
|
|
|
by Critical Therapeutics if (i) Cornerstones board of
directors fails to recommend that Cornerstones
stockholders vote to approve the merger agreement and the merger
or withdraws or modifies its recommendation, (ii) after the
receipt by Cornerstone of an acquisition proposal,
Cornerstones board of directors fails to reconfirm its
recommendation of the merger agreement or the merger within five
business days after a request by Critical Therapeutics for such
reconfirmation, (iii) Cornerstones board of directors
approves or recommends to Cornerstones stockholders any
acquisition proposal, (iv) a tender offer or exchange offer
for outstanding shares of Cornerstones common stock is
commenced and Cornerstones board of directors recommends
that Cornerstones stockholders tender their shares in such
offer or fails to recommend against acceptance of such offer
within 10 business days following commencement of such offer or
(v) Cornerstone breaches its non-solicitation obligations or
stockholder covenants (each of clauses (i) through
(v) above is referred to herein as a Cornerstone
Triggering Event);
|
|
|
|
by Cornerstone if (i) Critical Therapeutics board of
directors fails to recommend that Critical Therapeutics
stockholders vote for the proposals presented at the special
meeting or withdraws or modifies its recommendation,
(ii) after the receipt by Critical Therapeutics of an
acquisition proposal, Critical Therapeutics board of
directors fails to reconfirm its recommendation of the merger
agreement or the merger within five business days after a
request by Cornerstone for such reconfirmation,
(iii) Critical Therapeutics board of directors
approves or recommends to Critical Therapeutics
stockholders any acquisition proposal, (iv) a tender offer
or exchange offer for outstanding shares of Critical
Therapeutics common stock is commenced (other than by
Cornerstone or its affiliates) and Critical Therapeutics
board of directors recommends that Critical Therapeutics
stockholders tender their shares in such offer or fails to
recommend against acceptance of such offer within 10 business
days following commencement of such offer, (v) Critical
Therapeutics breaches its non-solicitation obligations or
stockholder covenants or (vi) Critical Therapeutics fails
to hold the special meeting of its stockholders by
November 28, 2008 (each of clauses (i) through
(vi) above is referred to herein as a Critical
Therapeutics Triggering Event);
|
|
|
|
by either Cornerstone or Critical Therapeutics if there has been
a breach of or failure to perform any representation, warranty,
covenant or agreement set forth in the merger agreement by the
other party which breach would cause conditions to the closing
of the merger not to be satisfied, and such failure or breach
with respect to any such representation, warranty, covenant or
agreement cannot be cured or, if curable, continues unremedied
for a period of 30 days after receipt of written notice
from the non-
|
147
|
|
|
|
|
breaching party of the occurrence of such failure or breach,
provided that in no event shall such 30 day period extend
beyond November 26, 2008, which written notice must be
provided promptly following such time as such party obtains
actual knowledge of such failure or breach (the events above are
referred to herein as an Uncured Breach);
|
|
|
|
|
|
by Critical Therapeutics if Cornerstone does not obtain
stockholder approval of the merger agreement by delivery of the
written consents of Cornerstones stockholders by
5:00 p.m., New York City time, on May 2, 2008; or
|
|
|
|
by Critical Therapeutics if (i) Cornerstone has not engaged
a new independent registered public accounting firm by
May 22, 2008, (ii) the audit of Cornerstones
financial statements as of the end of and for each of the last
three fiscal years and a review in accordance with Statement on
Auditing Standards No. 100 of the unaudited financial
statements required to be included in this
Form S-4
by Cornerstones new auditors has not been completed by
August 31, 2008 or (iii) the audit performed by
Cornerstones new auditors reflects a material adverse
change with respect to the assets, liabilities, capitalization,
financial condition or results of operations of Cornerstone as
compared to the financial statements delivered by Cornerstone
for such periods prior to the execution of the merger agreement
(each of clauses (i) through (iii) above is referred
to herein as the Cornerstone Audit Requirements).
|
Termination
Fee
Fee
Payable by Critical Therapeutics
Critical Therapeutics must pay Cornerstone a termination fee of
$1.0 million if the merger agreement is terminated
(i) by Cornerstone because the merger has not occurred by
November 30, 2008 if the merger has not occurred by such
date due to the failure of Critical Therapeutics to satisfy
closing conditions relating to approval by Critical
Therapeutics stockholders of the proposals presented at
the special meeting, the fulfillment of Critical
Therapeutics obligations under the merger agreement or
delivery of the stockholder agreements entered into with
Critical Therapeutics stockholders, (ii) by
Cornerstone or Critical Therapeutics because Critical
Therapeutics stockholders failed to approve the proposals
presented at the special meeting if at or prior to the time of
such failure an acquisition proposal relating to Critical
Therapeutics was announced and was not abandoned or withdrawn or
(iii) by Cornerstone because of the occurrence of a
Critical Therapeutics Triggering Event or an Uncured Breach by
Critical Therapeutics.
In addition, Critical Therapeutics must pay Cornerstone up to
$150,000 as reimbursement for expenses incurred in connection
with the merger if the merger agreement is terminated
(i) by either Cornerstone or Critical Therapeutics because
the merger has not occurred by November 30, 2008 if the
merger has not occurred by such date due to the failure of
Critical Therapeutics to satisfy closing conditions relating to
approval by Critical Therapeutics stockholders of the
proposals presented at the special meeting, the accuracy of
Critical Therapeutics representations and warranties, the
fulfillment of Critical Therapeutics obligations under the
merger agreement or delivery of the stockholder agreements of
Critical Therapeutics stockholders, (ii) by either
Cornerstone or Critical Therapeutics because Critical
Therapeutics stockholders failed to approve the proposals
presented at the special meeting or (iii) by Cornerstone
because of the occurrence of a Critical Therapeutics Triggering
Event or an Uncured Breach by Critical Therapeutics.
Fee
Payable by Cornerstone
Cornerstone must pay Critical Therapeutics a termination fee of
$1.0 million if the merger agreement is terminated by
Critical Therapeutics because (i) the merger has not
occurred by November 30, 2008 if the merger has not
occurred by such date due to the failure of Cornerstone to
satisfy closing conditions relating to approval of the merger
agreement and the merger by Cornerstones stockholders, the
fulfillment of Cornerstones obligations under the merger
agreement, the conversion or exchange of the outstanding
principal amount of the Carolina Note into shares of
Cornerstones common stock, delivery of the noteholder
agreement entered into with Carolina Pharmaceuticals or delivery
of the stockholder agreements entered into with
Cornerstones stockholders, (ii) a Cornerstone
Triggering Event or an Uncured Breach by Cornerstone has
occurred, (iii) Cornerstone has not obtained stockholder
approval of the written consents of Cornerstones
148
stockholders by 5:00 p.m., New York City time, on
May 2, 2008 or (iv) Cornerstones failure to meet
the Cornerstone Audit Requirements.
In addition, Cornerstone must pay Critical Therapeutics up to
$100,000 as reimbursement for expenses incurred in connection
with the merger if the merger agreement is terminated
(i) by either Cornerstone or Critical Therapeutics because
the merger has not occurred by November 30, 2008 if the
merger has not occurred by such date due to the failure of
Cornerstone to satisfy closing conditions relating to approval
of the merger agreement and the merger by Cornerstones
stockholders, the accuracy of Cornerstones representations
and warranties, the fulfillment of Cornerstones
obligations under the merger agreement, the conversion or
exchange of the outstanding principal amount of the Carolina
Note into shares of Cornerstones common stock, delivery of
the noteholder agreement entered into with Carolina
Pharmaceuticals or delivery of the stockholder agreements of
Cornerstones stockholders or (ii) by Critical
Therapeutics due to (A) a Cornerstone Triggering Event,
(B) an Uncured Breach by Cornerstone,
(C) Cornerstones failure to obtain approval by its
stockholders of the merger agreement and merger or
(D) Cornerstones failure to meet the Cornerstone
Audit Requirements.
Representations
and Warranties
The merger agreement contains customary representations and
warranties of Critical Therapeutics, Cornerstone and the
transitory subsidiary for a transaction of this type. Critical
Therapeutics representations and warranties are qualified
by its disclosure schedules and, in some cases, by Critical
Therapeutics SEC reports. Cornerstones
representations and warranties are qualified by its disclosure
schedules. The representations and warranties in the merger
agreement relate to, among other things:
|
|
|
|
|
corporate organization, standing and power;
|
|
|
|
capital structure;
|
|
|
|
subsidiaries;
|
|
|
|
authority, no conflict, required filings and consents;
|
|
|
|
financial statements and, with respect to Critical Therapeutics,
documents filed with the SEC and the accuracy of information
contained in those documents;
|
|
|
|
any undisclosed liabilities;
|
|
|
|
any material changes or events;
|
|
|
|
tax matters;
|
|
|
|
owned and leased real property;
|
|
|
|
intellectual property;
|
|
|
|
agreements, contracts and commitments;
|
|
|
|
litigation matters;
|
|
|
|
environmental matters;
|
|
|
|
employment benefit plans;
|
|
|
|
employee and labor matters;
|
|
|
|
compliance with laws
|
|
|
|
permits and regulatory matters;
|
|
|
|
agreements with employees;
|
|
|
|
insurance matters;
|
|
|
|
with respect to Critical Therapeutics, the opinion of Critical
Therapeutics financial advisor;
|
149
|
|
|
|
|
with respect to Critical Therapeutics, the inapplicability of
the provisions of Section 203 of the Delaware General
Corporation Law to the merger;
|
|
|
|
the absence of any existing discussions regarding an acquisition
proposal;
|
|
|
|
controls and procedures, certifications and other matters
related to the Sarbanes-Oxley Act;
|
|
|
|
with respect to Cornerstone, transactions with affiliates;
|
|
|
|
brokers fees and expenses;
|
|
|
|
with respect to Cornerstone, books and records; and
|
|
|
|
with respect to Critical Therapeutics, the operations of the
transitory subsidiary.
|
The representations and warranties are, in many respects,
qualified by materiality and knowledge, and will not survive the
merger, but their accuracy forms the basis of one of the
conditions to the obligations of Cornerstone and Critical
Therapeutics to complete the merger.
The merger agreement may be amended by the parties by action
taken or authorized by their respective board of directors, at
any time before or after approval of the matters presented in
connection with the merger by the stockholders of any of the
parties, but, after any such approval, no amendment shall be
made which by law requires further approval of such stockholders
without such further approval.
On August 7, 2008, the parties entered into an amendment to
the merger agreement to correct an erroneous reference in the
merger agreement to the product
Tussionex®
being owned by Cornerstone. The merger agreement should have
referred to Cornerstones extended-release antihistamine
and hydrocodone cough suppressant product candidates that, if
approved by the FDA, will compete with Tussionex in the
hydrocodone cough suppressant market. The foregoing summary of
this amendment is not complete and is qualified in its entirety
by reference to the full text of the amendment, which is
included in Annex A to this proxy
statement/prospectus and is incorporated by reference herein.
Cornerstone
Operating Company Guarantee
Cornerstone BioPharma, Inc., a Nevada corporation and a wholly
owned subsidiary of Cornerstone, is guaranteeing the performance
by Cornerstone of its obligations under the merger agreement and
is jointly and severally liable for payment of any termination
fee or expenses owing to Critical Therapeutics under the merger
agreement.
150
AGREEMENTS
RELATED TO THE MERGER
Cornerstone
Stockholder Agreements
In connection with the execution of the merger agreement,
holders of approximately 81% of the shares of Cornerstones
outstanding common stock have entered into agreements with
Critical Therapeutics that provide, among other things, that the
stockholders will vote in favor of adoption of the merger
agreement and grant to Critical Therapeutics an irrevocable
proxy to vote all of such stockholders shares of
Cornerstone common stock in favor of adoption of the merger
agreement and against any proposal made in opposition to, or in
competition with, the proposal to adopt the merger agreement. In
addition, these Cornerstone stockholders have agreed not to
transfer or otherwise dispose of any shares of Critical
Therapeutics common stock that they receive in the merger
for 180 days after the effective time of the merger. In
addition, certain directors and officers of Cornerstone that
hold options to acquire Cornerstones common stock have
entered into identical stockholder agreements that would apply
to any Cornerstone stock beneficially owned at the effective
time of the merger.
The Cornerstone stockholders and option holders that entered
into the stockholder agreements with Critical Therapeutics are
Cornerstone Biopharma Holdings, Ltd., Craig A. Collard, Craig
Collard Irrevocable Trust, James V. Baker, Chenyqua Baldwin,
Lutz Family Limited Partnership, Alastair McEwan, George Esgro,
Brian Dickson, and Steven M. Lutz.
Cornerstone
Noteholder Agreement
Carolina Pharmaceuticals, which is the holder of the Carolina
Note, has entered into an agreement that provides, among other
things, for the conversion or exchange of the outstanding
principal amount of the Carolina Note into approximately 18% of
the shares of Cornerstones common stock outstanding
immediately prior to the effective time of the merger and for
the same voting and
lock-up
provisions provided for pursuant to the agreements that
Cornerstones other stockholders have entered into.
Critical
Therapeutics Stockholder Agreements
In connection with the execution of the merger agreement,
several funds managed by Healthcare Ventures and Advanced
Technology Ventures, which, as of May 1, 2008, owned in the
aggregate approximately 19% of Critical Therapeutics
outstanding common stock, have entered into agreements that
provide among other things, that the stockholders grant to
Cornerstone and each of its executive officers an irrevocable
proxy to vote their shares in favor of the issuance of Critical
Therapeutics common stock in the merger and against any
proposal made in opposition to, or in competition with, the
proposal to issue Critical Therapeutics common stock in
connection with the merger.
The Critical Therapeutics stockholders that entered into the
voting agreements with Cornerstone are HealthCare Ventures VI,
L.P, HealthCare Ventures VII, L.P., Advanced Technology Ventures
VII, L.P., Advanced Technology Ventures VII (B), L.P., Advanced
Technology Ventures VII (C), L.P., ATV Entrepreneurs VII, L.P.,
ATV Alliance 2003, L.P., Advanced Technology Ventures VI, L.P.
and ATV Entrepreneurs VI, L.P.
151
MATTERS
BEING SUBMITTED TO A VOTE OF CRITICAL THERAPEUTICS
STOCKHOLDERS
Proposal 1:
Approval of the Issuance of Common Stock in the Merger
General
At the special meeting, Critical Therapeutics stockholders
will be asked to approve the issuance of Critical
Therapeutics common stock pursuant to the merger
agreement. Immediately following the effective time of the
merger, Cornerstones stockholders will own approximately
70%, and Critical Therapeutics current stockholders will
own approximately 30%, of Critical Therapeutics common
stock, assuming the exchange or conversion prior to the merger
of the outstanding principal amount of the Carolina Note into
shares of Cornerstones common stock and after giving
effect to shares issuable pursuant to Cornerstones
outstanding options and warrants, but without giving effect to
any shares issuable pursuant to Critical Therapeutics
outstanding options and warrants, subject to various assumptions
and conditions described in detail in this proxy
statement/prospectus. The terms of, reasons for and other
aspects of the merger agreement and the issuance of Critical
Therapeutics common stock pursuant to the merger agreement
are described in detail in the other sections of this proxy
statement/prospectus.
The full text of the merger agreement is attached to this proxy
statement/prospectus as Annex A.
Required
Vote; Recommendation of Board of Directors
The affirmative vote of the holders of a majority of the shares
of Critical Therapeutics common stock present in person or
represented by proxy and voting on such matter at the special
meeting is required for approval of Proposal 1.
A failure to submit a proxy card or vote at the special meeting,
or an abstention, vote withheld or broker non-vote
will have no effect on the outcome of Proposal 1.
CRITICAL THERAPEUTICS BOARD OF DIRECTORS UNANIMOUSLY
RECOMMENDS THAT CRITICAL THERAPEUTICS STOCKHOLDERS VOTE
FOR PROPOSAL 1 TO APPROVE THE ISSUANCE OF
CRITICAL THERAPEUTICS COMMON STOCK PURSUANT TO THE MERGER
AGREEMENT.
Proposal 2:
Approval of the Reverse Stock Split
General
At the special meeting, Critical Therapeutics stockholders
will be asked to approve an amendment to Critical
Therapeutics certificate of incorporation to effect a
reverse stock split of the issued and outstanding shares of
Critical Therapeutics common stock. Upon the effectiveness
of the amendment to Critical Therapeutics certificate of
incorporation effecting the reverse stock split, the outstanding
shares of Critical Therapeutics common stock will be
reclassified and combined into a lesser number of shares such
that one share of Critical Therapeutics common stock will
be issued for a specified number of shares, which shall be
greater than one and equal to or less than 50, of outstanding
Critical Therapeutics common stock, with the exact number
within the range to be determined by Critical Therapeutics
board of directors prior to the effective time of such amendment
and publicly announced by Critical Therapeutics. By approving
the reverse stock split, the stockholders of Critical
Therapeutics are approving individual amendments to Critical
Therapeutics certificate of incorporation for each number
in such range. After the board of directors has selected the
number in such range to effect the reverse stock split, Critical
Therapeutics will abandon all amendments to the certificate of
incorporation except the amendment with respect to the number
selected by the board of directors. If Proposal 2 is
approved, the reverse stock split would become effective
immediately prior to the effective time the merger. Critical
Therapeutics board of directors may effect only one
reverse stock split in connection with this Proposal 2.
Critical Therapeutics board of directors decision
will be based on a number of factors, including market
conditions, existing and expected trading prices for Critical
Therapeutics common stock and the listing requirements of
The NASDAQ Capital Market. Even if the stockholders approve the
reverse stock split, Critical Therapeutics reserves the right
not to effect the reverse stock split if Critical
Therapeutics board
152
of directors does not deem the reverse stock split to be in the
best interests of Critical Therapeutics and its stockholders.
Critical Therapeutics board of directors may determine to
effect the reverse stock split, if it is approved by the
stockholders, even if the other proposals to be acted upon at
the meeting are not approved, including the issuance of shares
of Critical Therapeutics common stock in the merger.
The form of the proposed amendment to the Critical Therapeutics
certificate of incorporation to effect the reverse stock split,
as more fully described below, will effect the reverse stock
split but will not change the number of authorized shares, or
the par value, of Critical Therapeutics common stock.
Purpose
Critical Therapeutics board of directors approved the
proposal authorizing the reverse stock split for the following
reasons:
|
|
|
|
|
because the initial listing standards of The NASDAQ Capital
Market will require Critical Therapeutics to have, among other
things, a $4.00 per share minimum bid price upon the closing of
the merger, the reverse stock split is necessary in order to
consummate the merger;
|
|
|
|
the board of directors believes effecting the reverse stock
split may be an effective means of avoiding a delisting of
Critical Therapeutics common stock from The NASDAQ Capital
Market in the future; and
|
|
|
|
the board of directors believes a higher stock price may help
generate investor interest in Critical Therapeutics and help
Critical Therapeutics attract and retain employees.
|
If the reverse stock split successfully increases the per share
price of Critical Therapeutics common stock, Critical
Therapeutics board of directors believes that this may
increase trading volume in Critical Therapeutics common
stock and facilitate future financings by Critical Therapeutics.
NASDAQ
Requirements for Listing on The NASDAQ Capital
Market
Critical Therapeutics common stock is listed on The NASDAQ
Capital Market under the symbol CRTX.
According to NASDAQ rules, an issuer must, in a case such as
this, apply for initial inclusion following a transaction
whereby the issuer combines with a non-NASDAQ entity, resulting
in a change of control of the issuer and potentially allowing
the non-NASDAQ entity to obtain a NASDAQ listing. These are
referred to as NASDAQs reverse merger rules.
Accordingly, the listing standards of The NASDAQ Capital Market
will require Critical Therapeutics to have, among other things,
a $4.00 per share minimum bid price upon the effective time of
the merger. Therefore, the reverse stock split is necessary in
order to consummate the merger.
Additionally, Critical Therapeutics board of directors
believes that maintaining its listing on The NASDAQ Capital
Market may provide a broader market for Critical
Therapeutics common stock and facilitate the use of
Critical Therapeutics common stock in financing and other
transactions. Critical Therapeutics board of directors
unanimously approved the reverse stock split partly as a means
of maintaining the share price of Critical Therapeutics
common stock following the merger above $4.00 per share.
One of the effects of the reverse stock split will be to
effectively increase the proportion of authorized shares which
are unissued relative to those which are issued. This could
result in the combined company being able to issue more shares
without further stockholder approval. Critical Therapeutics
currently has no plans to issue shares, other than in connection
with the merger, and to satisfy obligations under Critical
Therapeutics employee stock options and warrants from time
to time as these options and warrants are exercised. The reverse
stock split will not affect the number of authorized shares of
Critical Therapeutics common stock, which will continue to
be 90,000,000.
Potential
Increased Investor Interest
On September 15, 2008, Critical Therapeutics common
stock closed at $0.22 per share. In approving the proposal
authorizing the reverse stock split, Critical Therapeutics
board of directors considered that Critical Therapeutics
common stock may not appeal to brokerage firms that are
reluctant to recommend lower priced
153
securities to their clients. Investors may also be dissuaded
from purchasing lower priced stocks because the brokerage
commissions, as a percentage of the total transaction, tend to
be higher for such stocks. Moreover, the analysts at many
brokerage firms do not monitor the trading activity or otherwise
provide coverage of lower priced stocks. Also, Critical
Therapeutics board of directors believes that most
investment funds are reluctant to invest in lower priced stocks.
There are risks associated with the reverse stock split,
including that the reverse stock split may not result in an
increase in the per share price of Critical Therapeutics
common stock.
Critical Therapeutics cannot predict whether the reverse stock
split will increase the market price for Critical
Therapeutics common stock. The history of similar stock
split combinations for companies in like circumstances is
varied. There is no assurance that:
|
|
|
|
|
the market price per share of Critical Therapeutics common
stock after the reverse stock split will rise in proportion to
the reduction in the number of shares of Critical
Therapeutics common stock outstanding before the reverse
stock split;
|
|
|
|
the reverse stock split will result in a per share price that
will attract brokers and investors who do not trade in lower
priced stocks;
|
|
|
|
the reverse stock split will result in a per share price that
will increase Critical Therapeutics ability to attract and
retain employees; or
|
|
|
|
the market price per share will either exceed or remain in
excess of the $1.00 minimum bid price as required by NASDAQ for
continued listing, or that Critical Therapeutics will otherwise
meet the requirements of NASDAQ for inclusion for trading on The
NASDAQ Capital Market.
|
The market price of Critical Therapeutics common stock
will also be based on Critical Therapeutics performance
and other factors, some of which are unrelated to the number of
shares outstanding. If the reverse stock split is effected and
the market price of Critical Therapeutics common stock
declines, the percentage decline as an absolute number and as a
percentage of Critical Therapeutics overall market
capitalization may be greater than would occur in the absence of
a reverse stock split. Furthermore, the liquidity of Critical
Therapeutics common stock could be adversely affected by
the reduced number of shares that would be outstanding after the
reverse stock split.
Principal
Effects of the Reverse Stock Split
If the stockholders approve the proposal to implement the
reverse stock split and Critical Therapeutics board of
directors implements the reverse stock split, Critical
Therapeutics will amend Critical Therapeutics certificate
of incorporation to effect the reverse stock split. The text of
the form of the proposed amendment to Critical
Therapeutics certificate of incorporation is attached to
this proxy statement/prospectus as Annex B.
The reverse stock split will be effected simultaneously for all
outstanding shares of Critical Therapeutics common stock.
The reverse stock split will affect all of Critical
Therapeutics stockholders uniformly and will not affect
any stockholders percentage ownership interests in
Critical Therapeutics, except to the extent that the reverse
stock split results in any of Critical Therapeutics
stockholders owning a fractional share. Common stock issued
pursuant to the reverse stock split will remain fully paid and
nonassessable. The reverse stock split will not affect Critical
Therapeutics continuing to be subject to the periodic
reporting requirements of the Exchange Act.
As of the effective time of the reverse stock split, Critical
Therapeutics will adjust and proportionately decrease the number
of shares of Critical Therapeutics common stock reserved
for issuance upon exercise of, and adjust and proportionately
increase the exercise price of, all options and warrants and
other rights to acquire Critical Therapeutics common
stock. In addition, as of the effective time of the reverse
stock split, Critical Therapeutics will adjust and
proportionately decrease the total number of shares of Critical
Therapeutics common stock that may be the subject of the
future grants under Critical Therapeutics stock option
plans.
154
Assuming reverse stock split ratios of one-for-fifty and
one-for-two, which are ratios based on whole numbers of shares
at the high end and low end of the range that Critical
Therapeutics stockholders are being asked to approve, the
following table sets forth the number of shares of Critical
Therapeutics common stock that would be (i) issued
and outstanding, (ii) reserved for issuance and
(iii) authorized for issuance and neither issued nor
reserved for issuance, in each case, both immediately prior to
the merger (but after the reverse stock split) and immediately
following the merger, based on information as of
September 29, 2008, the last practicable date before the
printing of this proxy statement/prospectus.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reverse Stock Split Ratio of One-for-Fifty
|
|
|
Reverse Stock Split Ratio of One-for-Two
|
|
|
|
Pre-Merger
|
|
|
Post-Merger
|
|
|
Pre-Merger
|
|
|
Post-Merger
|
|
|
Number of Shares of Common Stock Issued and Outstanding
|
|
|
866,652
|
|
|
|
2,505,163
|
|
|
|
21,666,299
|
|
|
|
62,629,076
|
|
Number of Shares of Common Stock Reserved for Issuance
|
|
|
267,142
|
|
|
|
657,631
|
|
|
|
6,678,548
|
|
|
|
16,440,776
|
|
Number of Shares of Common Stock Authorized for Issuance and
neither Issued nor Reserved for Issuance
|
|
|
88,866,206
|
|
|
|
86,837,206
|
|
|
|
61,655,153
|
|
|
|
10,930,148
|
|
At the effective time of the merger, each share of
Cornerstones common stock will be converted into and
exchanged for the right to receive a number of shares of
Critical Therapeutics common stock equal to the product of
2.3333 multiplied by the quotient of 43,479,198, which was the
number of outstanding shares of Critical Therapeutics
common stock on April 30, 2008, divided by the number of
shares of Cornerstones common stock outstanding
immediately prior to the effective time of the merger, assuming
the exercise or conversion of all outstanding Cornerstone stock
options and warrants, subject to adjustment for the reverse
stock split of Critical Therapeutics common stock. As of
September 29, 2008, the last practicable date before the
printing of this proxy statement/prospectus,
41,422,225 shares of Cornerstones common stock were
outstanding, assuming the exchange or conversion prior to the
merger of the outstanding principal amount of the Carolina Note
into shares of Cornerstones common stock and the exercise
or conversion of all outstanding Cornerstone stock options and
warrants. If the merger had been completed as of
September 29, 2008, assuming a reverse stock split ratio of
one-for-fifty, each share of Cornerstones common stock
would have converted into and been exchanged for the right to
receive 0.0489834 shares of Critical Therapeutics
common stock, which would have resulted in an aggregate issuance
of 2,029,000 shares of Critical Therapeutics common
stock, including shares issuable pursuant to outstanding stock
options and warrants. If the merger had been completed as of
September 29, 2008, assuming a reverse stock split ratio of
one-for-two, each share of Cornerstones common stock would
have converted into and been exchanged for the right to receive
1.224584 shares of Critical Therapeutics common
stock, which would have resulted in an aggregate issuance of
50,725,006 shares of Critical Therapeutics common
stock, including shares issuable pursuant to outstanding stock
options and warrants.
Procedure
for Effecting Reverse Stock Split and Exchange of Stock
Certificates
If Critical Therapeutics stockholders approve the proposal
to effect the reverse stock split, and if Critical
Therapeutics board of directors still believes that a
reverse stock split is in the best interests of Critical
Therapeutics and its stockholders, Critical Therapeutics
board of directors will determine the ratio of the reverse stock
split to be implemented. Critical Therapeutics will file the
certificate of amendment with the Secretary of State of the
State of Delaware immediately prior to the effective time of the
merger. Critical Therapeutics board of directors may delay
effecting the reverse stock split without resoliciting
stockholder approval. Beginning on the effective date of the
reverse stock split, each certificate representing pre-split
shares will be deemed for all corporate purposes to evidence
ownership of post-split shares.
As soon as practicable after the effective date of the reverse
stock split, stockholders will be notified that the reverse
stock split has been effected. Critical Therapeutics expects
that Critical Therapeutics transfer agent will act as
exchange agent for purposes of implementing the exchange of
stock certificates. Holders of pre-split shares will be asked to
surrender to the exchange agent certificates representing
pre-split shares in
155
exchange for certificates representing post-split shares in
accordance with the procedures to be set forth in a letter of
transmittal to be sent by Critical Therapeutics. No new
certificates will be issued to a stockholder until such
stockholder has surrendered such stockholders outstanding
certificate(s) together with the properly completed and executed
letter of transmittal to the exchange agent. Any pre-split
shares submitted for transfer, whether pursuant to a sale or
other disposition, or otherwise, will automatically be exchanged
for post-split shares. STOCKHOLDERS SHOULD NOT DESTROY ANY STOCK
CERTIFICATE(S) AND SHOULD NOT SUBMIT ANY CERTIFICATE(S) UNLESS
AND UNTIL REQUESTED TO DO SO.
Fractional
Shares
No certificates or scrip representing fractional shares of
Critical Therapeutics common stock will be issued in
connection with the reverse stock split. Each holder of Critical
Therapeutics common stock who would otherwise have been
entitled to receive a fraction of a share of Critical
Therapeutics common stock (after taking into account all
fractional shares of Critical Therapeutics common stock
otherwise issuable to such holder) shall be entitled to receive,
in lieu thereof, upon surrender of such holders
certificate(s) representing such fractional shares of Critical
Therapeutics common stock, cash (without interest) in an
amount equal to such fractional part of a share of Critical
Therapeutics common stock multiplied by the average last
reported sales price of Critical Therapeutics common stock
at 4:00 p.m., Eastern time, end of regular trading hours on
NASDAQ during the 10 consecutive trading days ending on the last
trading day prior to the effective date of the merger.
By authorizing the reverse stock split, stockholders will be
approving the combination of any number of shares of common
stock between and including a number that is greater than one
and less than or equal to 50 into one share. The certificate of
amendment filed with the Secretary of State of the State of
Delaware will include only that number determined by the board
of directors to be in the best interests of Critical
Therapeutics and its stockholders. In accordance with these
resolutions, the board of directors will not implement any
amendment providing for a different split ratio.
Critical Therapeutics stockholders should be aware that,
under the escheat laws of the various jurisdictions where
stockholders reside, where Critical Therapeutics is domiciled,
and where the funds will be deposited, sums due for fractional
interests that are not timely claimed after the effective date
of the split may be required to be paid to the designated agent
for each such jurisdiction, unless correspondence has been
received by Critical Therapeutics or the exchange agent
concerning ownership of such funds within the time permitted in
such jurisdiction. Thereafter, stockholders otherwise entitled
to receive such funds will have to seek to obtain them directly
from the state to which they were paid.
Accounting
Matters
The reverse stock split will not affect the common stock capital
account on Critical Therapeutics balance sheet. However,
because the par value of Critical Therapeutics common
stock will remain unchanged on the effective date of the split,
the components that make up the common stock capital account
will change by offsetting amounts. Depending on the size of the
reverse stock split the board of directors decides to implement,
the stated capital component will be reduced and the additional
paid-in capital component will be increased with the amount by
which the stated capital is reduced. The per share net income or
loss and net book value of Critical Therapeutics will be
increased because there will be fewer shares of Critical
Therapeutics common stock outstanding. Prior periods
per share amounts will be restated to reflect the reverse stock
split.
Potential
Anti-Takeover Effect
Although the increased proportion of unissued authorized shares
to issued shares could, under certain circumstances, have an
anti-takeover effect, for example, by permitting issuances that
would dilute the stock ownership of a person seeking to effect a
change in the composition of Critical Therapeutics board
of directors or contemplating a tender offer or other
transaction for the combination of Critical Therapeutics with
another company, the reverse stock split proposal is not being
proposed in response to any effort of which
156
Critical Therapeutics is aware to accumulate shares of Critical
Therapeutics common stock or obtain control of Critical
Therapeutics, other than in connection with the merger with
Cornerstone, nor is it part of a plan by management to recommend
a series of similar amendments to Critical Therapeutics
board of directors and stockholders. Other than the proposals
being submitted to Critical Therapeutics stockholders for
their consideration at the special meeting, Critical
Therapeutics board of directors does not currently
contemplate recommending the adoption of any other actions that
could be construed to affect the ability of third parties to
take over or change control of Critical Therapeutics.
No
Appraisal Rights
Under the Delaware General Corporation Law, Critical
Therapeutics stockholders are not entitled to appraisal
rights with respect to the reverse stock split, and Critical
Therapeutics will not independently provide stockholders with
any such right.
Material
U.S. Federal Income Tax Consequences of the Reverse Stock
Split
The following discussion summarizes the material
U.S. federal income tax consequences of the reverse stock
split that are expected to apply generally to Critical
Therapeutics stockholders as a result of the reverse stock
split. This summary is based upon current provisions of the
Code, existing Treasury Regulations and current administrative
rulings and court decisions, all of which are subject to change
and to differing interpretations, possibly with retroactive
effect.
This summary only applies to a Critical Therapeutics stockholder
that is a U.S. person, defined to include:
|
|
|
|
|
a citizen or resident of the United States;
|
|
|
|
a corporation created or organized in or under the laws of the
United States, or any political subdivision thereof (including
the District of Columbia);
|
|
|
|
an estate, the income of which is subject to U.S. federal
income taxation regardless of its source;
|
|
|
|
a trust if either:
|
|
|
|
|
|
a court within the United States is able to exercise primary
supervision over the administration of such trust and one or
more U.S. persons have the authority to control all
substantial decisions of such trust; or
|
|
|
|
the trust has a valid election in effect to be treated as a
U.S. person for U.S. federal income tax
purposes; and
|
|
|
|
|
|
any other person or entity that is treated for U.S. federal
income tax purposes as if it were one of the foregoing.
|
Any Critical Therapeutics stockholder other than a
U.S. person as so defined is, for purposes of
this discussion, a
non-U.S. person.
If a partnership holds Critical Therapeutics common stock,
the tax treatment of a partner will generally depend on the
status of the partner and the activities of the partnership. If
you are a partner of a partnership holding Critical
Therapeutics common stock, you should consult your tax
advisor.
This summary assumes that Critical Therapeutics
stockholders hold their shares of Critical Therapeutics
common stock as capital assets within the meaning of
Section 1221 of the Code (generally, property held for
investment). No attempt has been made to comment on all
U.S. federal income tax consequences of the reverse stock
split that may be relevant to particular holders, including
holders:
|
|
|
|
|
who are subject to special treatment under U.S. federal
income tax rules such as dealers in securities, financial
institutions,
non-U.S. persons,
mutual funds, regulated investment companies, real estate
investment trusts, insurance companies, or tax-exempt entities;
|
|
|
|
who acquired their shares in connection with stock option or
stock purchase plans or in other compensatory transactions;
|
|
|
|
who hold their shares as qualified small business stock within
the meaning of Section 1202 of the Code;
|
157
|
|
|
|
|
who hold their shares as part of an integrated investment such
as a hedge or as part of a hedging, straddle or other risk
reduction strategy; or
|
|
|
|
who do not hold their shares as capital assets.
|
In addition, the following discussion does not address the tax
consequences of the reverse stock split under state, local and
foreign tax laws or under the alternative minimum tax provisions
of the Code. Furthermore, the following discussion does not
address any of the tax consequences of transactions effectuated
before, after or at the same time as the reverse stock split,
whether or not they are in connection with the reverse stock
split, including, without limitation, transactions in which
shares of Critical Therapeutics common stock are acquired
or disposed of.
Accordingly, holders of Critical Therapeutics common
stock are advised and expected to consult their own tax advisers
regarding the U.S. federal income tax consequences of the
reverse stock split to them in light of their personal
circumstances and the consequences of the reverse stock split
under state, local and foreign tax laws.
Other than the cash payments for fractional shares discussed
below, no gain or loss should be recognized by a Critical
Therapeutics stockholder upon such stockholders exchange
of pre-split shares for post-split shares pursuant to the
reverse stock split. The aggregate tax basis of the post-split
shares received in the reverse stock split, including any
fraction of a post-split share deemed to have been received,
will be the same as the Critical Therapeutics stockholders
aggregate tax basis in the pre-split shares that are exchanged.
In general, Critical Therapeutics stockholders who receive cash
upon the deemed sale of their fractional share interests in the
post-split shares as a result of the reverse stock split will
recognize gain or loss equal to the difference between their
basis in the fractional share and the amount of cash received.
The Critical Therapeutics stockholders holding period for
the post-split shares will include the period during which the
stockholder held the pre-split shares surrendered in the reverse
stock split.
Such gain or loss will be a capital gain or loss, and generally
will constitute a long-term capital gain or loss if the
stockholders holding period in the stock exchanged is more
than one year as of the closing date of the reverse stock split.
Net capital gain (i.e., the excess of net long-term capital gain
over net short-term capital loss) will be subject to tax at
reduced rates for non-corporate stockholders who receive cash.
The deductibility of capital losses is subject to various
limitations for corporate and non-corporate holders.
For purposes of the above discussion of bases and holding
periods, stockholders who acquired different blocks of stock at
different times for different prices must calculate their gains
and losses and holding periods separately for each identifiable
block of such stock exchanged in the reverse stock split.
Certain noncorporate Critical Therapeutics stockholders may be
subject to backup withholding, at a rate of 28% for 2008, on
cash received pursuant to the reverse stock split. Backup
withholding will not apply, however, to a Critical Therapeutics
stockholder who (1) furnishes a correct taxpayer
identification number and certifies that the Critical
Therapeutics stockholder is not subject to backup withholding on
IRS
Form W-9
or a substantially similar form, (2) provides a
certification of foreign status on an appropriate
Form W-8
or successor form or (3) is otherwise exempt from backup
withholding. If a Critical Therapeutics stockholder does not
provide a correct taxpayer identification number on IRS
Form W-9
or a substantially similar form, the Critical Therapeutics
stockholder may be subject to penalties imposed by the IRS.
Amounts withheld, if any, are generally not an additional tax
and may be refunded or credited against the Critical
Therapeutics stockholders federal income tax liability,
provided that the Critical Therapeutics stockholder furnishes
the required information to the IRS.
THE PRECEDING DISCUSSION IS INTENDED ONLY AS A SUMMARY OF THE
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES OF THE
REVERSE STOCK SPLIT AND DOES NOT PURPORT TO BE A COMPLETE
ANALYSIS OR DISCUSSION OF ALL OF THE REVERSE STOCK SPLITS
POTENTIAL TAX EFFECTS. CRITICAL THERAPEUTICS STOCKHOLDERS ARE
URGED TO CONSULT THEIR OWN TAX ADVISORS AS TO THE SPECIFIC TAX
CONSEQUENCES TO THEM OF THE REVERSE STOCK SPLIT, INCLUDING TAX
RETURN
158
REPORTING REQUIREMENTS, AND THE APPLICABILITY AND EFFECT OF
FEDERAL, STATE, LOCAL AND OTHER APPLICABLE TAX LAWS.
Vote
Required; Recommendation of Board of Directors
The affirmative vote of holders of a majority of the outstanding
shares of Critical Therapeutics common stock as of the
record date for the special meeting is required for approval of
Proposal 2.
A failure to submit a proxy card or vote at the special meeting,
or an abstention, vote withheld or broker non-vote
for Proposal 2 will have the same effect as a vote against
the approval of Proposal 2.
CRITICAL THERAPEUTICS BOARD OF DIRECTORS UNANIMOUSLY
RECOMMENDS THAT CRITICAL THERAPEUTICS STOCKHOLDERS VOTE
FOR PROPOSAL 2 TO AMEND CRITICAL
THERAPEUTICS CERTIFICATE OF INCORPORATION TO EFFECT THE
REVERSE STOCK SPLIT.
Proposal 3:
Approval of Name Change
General
At the special meeting, holders of Critical Therapeutics common
stock will be asked to approve the amendment of Critical
Therapeutics certificate of incorporation to change the
name of the corporation from Critical Therapeutics to
Cornerstone Therapeutics Inc. immediately following
the effective time of the merger.
The primary reason for the corporate name change is that
management believes this will allow for brand recognition of
Cornerstones products and product candidate pipeline
following the consummation of the merger. Critical
Therapeutics management believes that the current name
will no longer accurately reflect the business of the combined
company and the mission of the combined company subsequent to
the consummation of the merger. The text of the form of the
proposed amendment to the Critical Therapeutics
certificate of incorporation is attached to this proxy
statement/prospectus as Annex C.
Insofar as the proposed new corporate name will only reflect
Cornerstones business following the merger, the proposed
name change and the amendment of Critical Therapeutics
certificate of incorporation, even if approved by the
stockholders at the special meeting, will only be filed with the
office of the Secretary of State of the State of Delaware and,
therefore, become effective if the merger is consummated.
Vote
Required; Recommendation of Board of Directors
The affirmative vote of holders of a majority of the outstanding
shares of Critical Therapeutics common stock as of the
record date for the special meeting is required for approval of
Proposal 3.
A failure to submit a proxy card or vote at the special meeting,
or an abstention, vote withheld or broker non-vote
for Proposal 3 will have the same effect as a vote against
the approval of Proposal 3.
CRITICAL THERAPEUTICS BOARD OF DIRECTORS UNANIMOUSLY
RECOMMENDS THAT CRITICAL THERAPEUTICS STOCKHOLDERS VOTE
FOR PROPOSAL 3 TO APPROVE THE NAME CHANGE.
Proposal 4:
Approval of Possible Adjournment of the Special
Meeting
General
If Critical Therapeutics fails to receive a sufficient number of
votes to approve Proposals 1, 2 or 3, Critical Therapeutics
may propose to adjourn the special meeting, if a quorum is
present, for a period of not more than 30 days for the
purpose of soliciting additional proxies to approve
Proposals 1, 2 or 3. Critical Therapeutics currently does
not intend to propose adjournment at the special meeting if
there are sufficient votes to approve Proposals 1, 2 and 3.
159
Vote
Required; Recommendation of Board of Directors
The affirmative vote of the holders of a majority of the
Critical Therapeutics common stock having voting power
present in person or represented by proxy at the special meeting
is required to approve the adjournment of the special meeting
for the purpose of soliciting additional proxies to approve
Proposals 1, 2 or 3.
A failure to submit a proxy card or vote at the special meeting,
or an abstention, vote withheld or broker non-vote
will have no effect on the outcome of Proposal 4.
CRITICAL THERAPEUTICS BOARD OF DIRECTORS UNANIMOUSLY
RECOMMENDS THAT CRITICAL THERAPEUTICS STOCKHOLDERS VOTE
FOR PROPOSAL 4 TO ADJOURN THE SPECIAL MEETING,
IF NECESSARY, IF A QUORUM IS PRESENT, TO SOLICIT ADDITIONAL
PROXIES IF THERE ARE NOT SUFFICIENT VOTES IN FAVOR OF
PROPOSALS 1, 2 OR 3.
160
CRITICAL
THERAPEUTICS BUSINESS
Overview
Critical Therapeutics is a biopharmaceutical company focused on
the development and commercialization of products designed to
treat respiratory diseases, as well as other inflammatory
diseases linked to the bodys inflammatory response.
Critical Therapeutics two marketed products are ZYFLO CR,
which the FDA approved in May 2007, and ZYFLO, which the FDA
approved in 1996, for the prevention and chronic treatment of
asthma in adults and children 12 years of age or older.
Critical Therapeutics licensed from Abbott exclusive worldwide
rights to ZYFLO CR, ZYFLO and other formulations of zileuton for
multiple diseases and conditions. Critical Therapeutics began
selling ZYFLO CR in the United States in September 2007 and
began selling ZYFLO in the United States in October 2005. In
addition, Critical Therapeutics is developing zileuton injection.
In September 2007, Critical Therapeutics sales force and
the sales force of its co-promotion collaborator, DEY, began
actively promoting ZYFLO CR and ceased actively promoting ZYFLO.
Critical Therapeutics ceased manufacturing and supplying ZYFLO
in February 2008, but resumed the supply of ZYFLO in September
2008 to help manage any potential impact to patients of supply
chain issues for ZYFLO CR. In April 2008, Critical Therapeutics
announced the results of a Phase I clinical trial designed to
examine the pharmacokinetic and pharmacodynamic profile of the
R(+) isomer of zileuton to determine if there are potential
dosing improvements for patients from this isomer. In addition,
Critical Therapeutics is developing zileuton injection initially
for use in emergency room or urgent care centers for patients
who suffer acute exacerbations of asthma. In June 2008, Critical
Therapeutics announced results from its Phase II clinical
trial with zileuton injection in patients with chronic, stable
asthma. Critical Therapeutics intends to initiate a process to
seek to enter into a collaboration agreement for the future
clinical development and commercialization of zileuton injection.
On March 13, 2007, Critical Therapeutics entered into an
agreement with DEY, under which Critical Therapeutics and DEY
agreed to jointly promote ZYFLO and ZYFLO CR. On June 25,
2007, Critical Therapeutics entered into a definitive agreement
with DEY to jointly promote DEYs product PERFOROMIST for
the treatment of COPD. In October 2007, Critical Therapeutics
announced that it had commercially launched PERFOROMIST with
DEY. On July 2, 2008, Critical Therapeutics provided notice
to DEY that Critical Therapeutics had exercised its contractual
right to terminate the co-promotion agreement for PERFOROMIST.
The termination is effective September 30, 2008.
Critical Therapeutics has been conducting preclinical work in
its alpha-7 program. Critical Therapeutics believes the
successful development of a small molecule product candidate
targeting the alpha-7 nicotinic acetylcholine receptor, or
alpha-7 receptor, could lead to a novel treatment for severe
acute inflammatory disease, as well as an oral anti-cytokine
therapy that could be directed at chronic inflammatory diseases
such as asthma and rheumatoid arthritis. Based on preclinical
studies, Critical Therapeutics selected lead and backup
molecules for evaluation in good laboratory practices, or GLP,
toxicology studies. Provided the data are supportive and
sufficient resources are available, Critical Therapeutics
believes that an investigational new drug application, or IND,
could be filed in 2009. In addition, Critical Therapeutics plans
to seek collaborations with other pharmaceutical companies for
its alpha-7 program to develop and commercialize possible
product candidates in multiple development opportunities that
may exist within this program prior to the initiation of human
clinical trials. Critical Therapeutics licensed to SetPoint
patent rights and know-how relating to the mechanical and
electrical stimulation of the vagus nerve. This license
agreement specifically excludes from the licensed field
pharmacological modulation of the alpha-7 receptor.
Critical Therapeutics has a collaboration agreement with
MedImmune for the development of monoclonal antibodies directed
toward a cytokine called HMGB1, which Critical Therapeutics
believes may be an important target for the development of
products to treat diseases mediated by the bodys
inflammatory response. In addition, Critical Therapeutics has a
collaboration agreement with Beckman Coulter for the development
of a diagnostic directed toward measuring HMGB1 in the
bloodstream.
161
Critical Therapeutics was incorporated in Delaware on
July 14, 2000 as Medicept, Inc. and changed its name to
Critical Therapeutics in March 2001. Critical Therapeutics
completed an initial public offering of its common stock in June
2004, and its common stock is currently traded on The NASDAQ
Capital Market.
Proposed
Merger with Cornerstone
Until the closing of the proposed merger with Cornerstone,
Critical Therapeutics expects to continue its commercial and
development activities in accordance with its existing business
strategy with an increased focus on managing its cash position.
The description of Critical Therapeutics business set
forth in this proxy statement/prospectus does not reflect any
changes to Critical Therapeutics business that may occur
if it consummates the proposed merger with Cornerstone. For
instance, the combined companys clinical and preclinical
pipeline will include a number of product candidates. The
combined company is expected to implement a strategic review of
its product development pipeline. Following the strategic
review, the combined company may seek to maximize the value of
any non-core programs through out-licensing, divestiture or
spin-off transactions.
Critical
Therapeutics Product Pipeline
The following table sets forth the current status of Critical
Therapeutics products and product candidates in
development and Critical Therapeutics research and
development programs:
* Being developed by MedImmune under an exclusive license and
collaboration agreement. Diagnostic assays directed towards
HMGB1 are being developed with Beckman Coulter under a license
agreement.
Zileuton
In 2003, Critical Therapeutics acquired from Abbott exclusive
worldwide rights to develop and market ZYFLO CR and other
formulations of zileuton for multiple diseases and conditions.
In 2004, Critical Therapeutics acquired from Abbott exclusive
worldwide rights to develop and market ZYFLO. The FDA approved
Critical Therapeutics sNDA for ZYFLO on September 28,
2005, and Critical Therapeutics began selling ZYFLO in the
United States in October 2005. Critical Therapeutics ceased
manufacturing and supplying ZYFLO in February 2008, but resumed
supply of ZYFLO in September 2008 to help manage the potential
impact to patients of supply chain issues for ZYFLO CR. The FDA
approved the NDA for ZYFLO CR on May 30, 2007, and Critical
Therapeutics subsequently launched ZYFLO CR in the United States
on September 27, 2007.
Zileuton blocks the activity of the 5-lipoxygenase enzyme, which
is the main enzyme responsible for formation of a family of
lipids known as leukotrienes. There are many different
leukotrienes, and the mechanism of action of ZYFLO CR and ZYFLO
blocks production of the entire leukotriene family.
162
Leukotrienes are in part responsible for the inflammatory
response associated with asthma and are known to cause many of
the biological effects that contribute to inflammation, mucus
production and closing of the lung airways of asthmatic
patients. Leukotrienes are also implicated in the disturbance of
normal lung airway function in other diseases, including COPD.
ZYFLO CR and ZYFLO are the only FDA-approved leukotreine
synthesis inhibitors for the prevention and chronic treatment of
asthma in adults and children 12 years of age and older.
Therapeutic
Opportunity
Asthma is a chronic respiratory disease characterized by the
narrowing of the lung airways, making breathing difficult. An
asthma attack leaves the victim short of breath as the airways
become constricted and inflamed. The National Center for Health
Statistics estimates that in 2005 approximately
22.2 million people in the United States had asthma and
approximately 12.2 million people in the United States had
asthma attacks. Severe asthma attacks can be life threatening.
The National Center for Health Statistics estimates that in 2005
approximately 1.8 million hospital emergency room visits in
the United States involved asthma attacks and approximately
488,594 hospital discharges were attributable to asthma.
There is no one ideal treatment for asthma, and there is no
cure. Currently, patients are treated with a combination of
products that are designed primarily to manage their disease
symptoms by opening the airways in the lungs and reducing
inflammation. Typical treatments include bronchodilatory drugs,
such as
Serevent®,
LTRAs, such as
Singulair®,
inhaled corticosteroids, such as
Flovent®
and combination products such as
Advair®,
which is a combination of an inhaled corticosteroid and a
long-acting bronchodilator. Critical Therapeutics believes many
prescribing physicians are dissatisfied with the treatment
options available for uncontrolled asthmatic patients due to the
inability of these treatments to control symptoms reliably. A
recent study, titled Real-world Evaluation of Asthma
Control and Treatment (REACT): Findings from a National
Web-based Survey and published in The Journal of
Allergy & Clinical Immunology, stated that nearly 55%
of all moderate to severe asthmatics remain uncontrolled despite
being treated with asthma medications.
Critical Therapeutics believes that many patients with asthma
may benefit from therapy with ZYFLO CR or ZYFLO. ZYFLO CR and
ZYFLO actively inhibit the main enzyme responsible for the
production of a broad spectrum of lipids responsible for the
symptoms associated with asthma, including all leukotrienes.
Critical Therapeutics is marketing ZYFLO CR and ZYFLO as
treatments for asthma patients who do not gain adequate
symptomatic control from other currently available medications.
Zileuton
Product Development
ZYFLO:
The Immediate-Release Formulation of Zileuton
ZYFLO and ZYFLO CR are the only leukotreine synthesis inhibitor
drugs to be approved for marketing by the FDA. In 1996, ZYFLO
was approved by the FDA as an immediate-release,
four-times-a-day tablet for the prevention and chronic treatment
of asthma in adults and children 12 years of age and older.
ZYFLO was first launched in the United States in 1997. The FDA
approved Critical Therapeutics sNDA for ZYFLO on
September 28, 2005, and Critical Therapeutics began selling
ZYFLO in the United States in October 2005. Critical
Therapeutics recognized revenue from sales of ZYFLO of $748,000
for the six months ended June 30, 2008, $8.7 million
in 2007, $6.6 million in 2006 and $387,000 in 2005.
Critical Therapeutics recognized revenue from sales of ZYFLO CR
of $6.5 million for the six months ended June 30, 2008
and $2.3 million in 2007. The full clinical development
program for ZYFLO consisted of 21 safety and efficacy trials in
an aggregate of approximately 3,000 patients with asthma.
FDA approval was based on pivotal three-month and six-month
safety and efficacy clinical trials in 774 asthma patients. The
pivotal trials compared patients taking ZYFLO and their rescue
bronchodilators as needed to patients taking placebo and rescue
bronchodilators as needed. The results of the group taking ZYFLO
and their rescue bronchodilators showed:
|
|
|
|
|
rapid and sustained improvement for patients over a six-month
period in objective and subjective measures of asthma control;
|
163
|
|
|
|
|
reduction of exacerbations and need for either bronchodilatory
or steroid rescue medications; and
|
|
|
|
acute bronchodilatory effect within two hours after the first
dose.
|
Critical Therapeutics post hoc analysis of the data
suggested there was a greater airway response benefit in asthma
patients with less than 50% of expected airway function, and a
six-fold decrease in the need for steroid rescue medication in
these patients compared to placebo.
In these placebo-controlled clinical trials, 1.9% of patients
taking ZYFLO experienced an increase in the liver enzyme ALT
greater than three times the level normally seen in the
bloodstream compared to 0.2% of patients receiving placebo.
These enzyme levels resolved or returned towards normal in
approximately 50% of the patients who continued therapy and all
of the patients who discontinued the therapy.
In addition, prior to FDA approval, a long-term, safety
surveillance trial was conducted in 2,947 patients. In this
safety trial, 4.6% of patients taking ZYFLO experienced ALT
levels greater than three times the level normally seen in the
bloodstream compared to 1.1% of patients receiving placebo. In
61.0% of the patients with ALT levels greater than three times
the level normally seen in the bloodstream, the elevation was
seen in the first two months of dosing. After two months of
treatment, the rate of ALT levels greater than three times the
level normally seen in the bloodstream stabilized at an average
of 0.3% per month for patients taking a combination of ZYFLO and
their usual asthma medications compared to 0.11% per month for
patients taking a combination of placebo and their usual asthma
medications. This trial also demonstrated that ALT levels
returned to below two times the level normally seen in the
bloodstream in both the patients who continued and those who
discontinued the therapy. The overall rate of patients with ALT
levels greater than three times the level normally seen in the
bloodstream was 3.2% in the approximately 5,000 patients
who received ZYFLO in placebo-controlled and open-label trials
combined. In these trials, one patient developed symptomatic
hepatitis with jaundice, which resolved upon discontinuation of
therapy, and three patients developed mild elevations in
bilirubin.
After reviewing the data from these trials, the FDA approved
ZYFLO in 1996 on the basis of the data submitted, and Critical
Therapeutics is not aware of any reports of ZYFLO being directly
associated with serious irreversible liver damage in patients
treated with ZYFLO since its approval.
ZYFLO CR:
The Extended-Release Formulation of Zileuton
Critical Therapeutics commercially launched ZYFLO CR in
September 2007, following its approval by the FDA in May 2007.
Critical Therapeutics believes ZYFLO CR offers a more convenient
regimen for patients because of its twice-daily, two tablets per
dose dosing regimen, as compared to ZYFLOs four-times
daily dosing regimen, which Critical Therapeutics believes may
increase patient drug compliance. Abbott completed
Phase III clinical trials for this formulation in asthma,
but did not submit an NDA. Critical Therapeutics submitted the
NDA for ZYFLO CR to the FDA based on safety and efficacy data
generated from two completed Phase III clinical trials, a
three-month efficacy trial and a six-month safety trial, each of
which was completed by Abbott. The study reports prepared by
Abbott for these clinical trials showed:
|
|
|
|
|
In a three-month pivotal efficacy trial, in which
397 patients received either ZYFLO CR or placebo, patients
taking ZYFLO CR demonstrated statistically significant
improvements over placebo in objective measures of asthma
control, such as mean forced expiratory volume in one second, or
FEV1.
In the trial, patients taking ZYFLO CR showed a reduced need for
bronchodilatory drugs as a rescue medication to alleviate
uncontrolled symptoms. In this trial, 2.5% of the patients
taking ZYFLO CR experienced ALT levels greater than or equal to
three times the level normally seen in the bloodstream, compared
to 0.5% of the patients taking placebo.
|
|
|
|
In a six-month safety trial, in which 706 patients received
either a combination of ZYFLO CR and their usual asthma
medications or a combination of placebo and their usual asthma
medications, 1.78% of the patients taking ZYFLO CR and their
usual asthma medications experienced ALT levels greater than or
equal to three times the level normally seen in the bloodstream,
compared to 0.65% of the patients taking placebo and their usual
asthma medications.
|
164
To be able to rely on the results of Abbotts pivotal
clinical trials, Critical Therapeutics conducted two comparative
bioavailability studies intended to show that the
pharmacokinetic profile of ZYFLO CR tablets that Critical
Therapeutics manufactured was similar to the pharmacokinetic
profile of the ZYFLO CR tablets previously manufactured by
Abbott and used in Abbotts clinical trials. Critical
Therapeutics conducted both a single-dose and a multiple-dose
pharmacokinetic study. The studies assessed the pharmacokinetics
of ZYFLO CR in volunteers under both fed and fasting conditions.
Critical Therapeutics entered into an agreement in March 2007
with DEY under which Critical Therapeutics and DEY jointly
co-promote ZYFLO CR and ZYFLO.
Zileuton
Injection
Critical Therapeutics is developing zileuton injection for use
as an adjunctive treatment for patients with acute exacerbations
of asthma. Critical Therapeutics believes acute exacerbations of
asthma are a significant unmet medical need that occur in asthma
patients who are poorly controlled on their existing
medications. According to the American Lung Association, in
2005, approximately 1.8 million hospital emergency room
visits in the United States involved asthma attacks and
approximately 488,594 hospital discharges were attributable to
asthma. Critical Therapeutics is developing zileuton injection
as a new treatment option for acute asthma patients in the
emergency department that can be added to existing therapies in
order to improve pulmonary function by controlling both
bronchospasm and pulmonary inflammation through zileutons
mechanism of action, leukotreine synthesis inhibition.
Currently, most patients suffering severe asthma attacks are
treated with bronchodilators inhaled via a nebulizer, typically
for 20 minutes or more. Nebulizers attempt to restore airway
function by delivering the bronchodilatory drug directly into
the lungs. However, the patients ability to get the drug
into his or her lungs may be impaired by his or her inability to
breathe efficiently due to the severe asthma attack. Clinical
data demonstrate that zileuton exhibits its maximum effect on
lung function when the blood drug concentration reaches its peak
level and that the effect can be achieved after a single oral
dose of zileuton. Critical Therapeutics believes that an
injectable formulation of zileuton that would deliver zileuton
directly to the bloodstream would have a rapid onset of action,
reaching peak blood concentration within minutes of the
injection. Critical Therapeutics believes that this rapid
delivery of the drug to the patients bloodstream may lead
to more rapid improvements in symptoms, and potentially reduce
the number of hospital admissions of patients arriving in the
emergency room suffering from a severe asthma attack.
In August 2006, Critical Therapeutics announced results from a
Phase I/II clinical trial with zileuton injection in chronic
stable asthmatics. The trial included measurements to detect
evidence of improvement in lung function. The multi-center,
double-blind, placebo-controlled trial enrolled 60 patients
with a mean
FEV1
of 63 percent of predicted normal at baseline and a mean
age of 40 years. Patients enrolled in the trial were
randomized into four escalating dose groups, 75 mg,
150 mg, 300 mg and 600 mg, and received one
infusion of either zileuton injection or placebo. Each of the
four dose groups enrolled 15 patients, of whom 12 received
zileuton injection and three received placebo. All
60 patients who were randomized completed the trial.
Patients in each of the four zileuton injection cohorts showed a
greater mean percentage improvement in
FEV1
than patients in the placebo group when measured at 10, 30 and
60-minute
intervals after dosing. The 300 mg dose was predicted to
approximate the blood level exposure of the currently approved
immediate-release oral dose of ZYFLO. In this trial, the
300 mg dose group showed a mean improvement in
FEV1
from baseline of 13.7 percent at 60 minutes after dosing.
In addition, zileuton injection was well tolerated at all doses
tested with no serious adverse events reported in the trial.
In June 2008, Critical Therapeutics announced top-line results
from a Phase II clinical trial with zileuton injection in
chronic stable asthmatics. The trial was designed to explore the
pulmonary function profile, safety, tolerability and
pharmacokinetic profile of zileuton injection. The multi-center,
double-blind, placebo-controlled, three-period cross-over trial
enrolled 36 patients with stable, moderate-to-severe asthma
and a
FEV1
of 40 percent to 80 percent of predicted normal. In
this trial, patients received a single dose of 150 mg or
300 mg of zileuton injection or placebo, administered via a
peripheral intravenous, or IV, catheter at a
165
standard continuous rate. The trial measured pulmonary function
using
FEV1
at multiple time points over the first hour then hourly until
six hours after dosing.
Zileuton injection, at both dose levels, was well tolerated in
all 36 patients and there were no serious adverse events
reported. Patients receiving each of the two zileuton injection
dose levels showed a numerically greater mean percentage
improvement in
FEV1
from baseline than patients receiving placebo; however, the
results were not statistically significant compared to placebo.
The mean percentage improvement in
FEV1
from baseline was evident from the first measurement time point
of 10 minutes after dosing and was maintained for at least four
hours. Critical Therapeutics believes that the variability in
baseline levels of
FEV1
seen within individual patients across the three dosing regimens
often resulted in higher than expected baseline lung function,
which did not provide an opportunity to achieve a meaningful
improvement in lung function that could approach statistical
significance. Exploratory analyses conducted on the trial data
indicate that patients with a baseline
FEV1
less than or equal to 65% of predicted normal responded better
to zileuton treatment.
Critical Therapeutics believes that these exploratory analyses
and the tolerability of zileuton injection may support a
clinical trial in an acute population as a potential next step
in the development process. Critical Therapeutics intends to
initiate a process to seek to enter into a collaboration
agreement for the future clinical development and
commercialization of zileuton injection.
Commercialization
Strategy
As of September 15, 2008, Critical Therapeutics has a
respiratory sales force of approximately 26 representatives who
are focused on promoting ZYFLO CR and PERFOROMIST to prescribing
physicians in major markets across the United States. Critical
Therapeutics is seeking to increase utilization of ZYFLO CR and
ZYFLO by prescribing physicians.
In March 2007, Critical Therapeutics entered into a co-promotion
agreement with DEY under which Critical Therapeutics and DEY
agreed to jointly promote ZYFLO and, after approval by the FDA,
ZYFLO CR. DEY has a respiratory sales force consisting of
approximately 200 clinical sales representatives as of
September 15, 2008. Under the co-promote agreement, DEY is
required to provide a specified number of details per month for
ZYFLO CR, in the second position, to office-based physicians and
other health care professionals, including a minimum number of
details delivered to respiratory specialists, such as allergists
and pulmonologists. Under the co-promotion agreement, Critical
Therapeutics has agreed to provide a specified number of details
per month for ZYFLO CR in the first position. From 2008 through
2010, Critical Therapeutics and DEY each have agreed to
contribute 50 percent of out-of-pocket promotion expenses
for ZYFLO CR that are accrued or paid to third-parties and
approved by a joint commercial committee. Critical Therapeutics
was responsible for third-party promotion costs during 2007.
Critical Therapeutics believes that there is a market
opportunity for the use of ZYFLO CR as an add-on therapy option
for patients whose asthma symptoms are not adequately controlled
with the use of inhaled corticosteroids and other conventional
therapies, including LTRAs and LABAs. Critical
Therapeutics belief is based on information that it has
gathered through extensive direct interactions and market
research with respiratory specialists, including allergists and
pulmonologists and primary care physicians, such as:
|
|
|
|
|
more than two years of in-depth interaction between Critical
Therapeutics medical science liaisons with key opinion
leaders in the treatment of respiratory diseases, including
asthma;
|
|
|
|
more than two years of interaction between Critical
Therapeutics sales force and respiratory specialists who
treat asthma; and
|
|
|
|
qualitative and quantitative market research that it has
conducted since 2004.
|
Critical Therapeutics is positioning ZYFLO CR as an alternative
treatment for asthma patients who do not gain adequate control
of their symptoms with other currently available medications,
including inhaled corticosteroids, long-acting beta agonists and
LTRAs. Critical Therapeutics is promoting ZYFLO CR to
respiratory specialists, managed care decision makers and some
primary care physicians who treat large volumes of asthma
patients. As part of its marketing strategy, Critical
Therapeutics attempts to educate key opinion leaders and
physicians on the scientific data that differentiates the
mechanism of action of ZYFLO CR
166
from other asthma treatments and emphasize clinical data that
show safety and efficacy for ZYFLO CR in asthma.
Critical Therapeutics believes that in most managed care
formularies ZYFLO CR and ZYFLO have been placed in formulary
positions that require a higher co-payment for patients
prescribed the product. In some cases, MCOs may require
additional evidence that a patient had previously failed another
therapy, additional paperwork or prior authorization from the
MCO before approving reimbursement for ZYFLO CR.
In June 2007, the National Heart Lung, and Blood Institute, or
NHLBI, released an updated version of the Guidelines for the
Diagnosis and Management of Asthma. In these guidelines,
zileuton is specifically mentioned in steps three and four in
the treatment spectrum as an alternative option in the treatment
of asthma. This is the first time zileuton has been mentioned in
these guidelines, and Critical Therapeutics believes this may
provide additional scientific credibility to ZYFLO CR in the
marketplace. In addition to the changes in the recommended
treatment protocol for asthma, the updated guidelines continue
to support the transition to discussing asthmatic patients in
terms of their level of control rather than their severity level.
Since the commercial launch of ZYFLO CR in September 2007,
Critical Therapeutics has experienced growth in overall
prescription volume and the number of physicians prescribing
ZYFLO CR, and it believes this growth is due to the greater
market acceptance of the twice-daily dosing of ZYFLO CR compared
to the four-times daily immediate-release formulation of ZYFLO.
Critical Therapeutics is exploring the therapeutic benefits of
zileuton in treating a range of diseases and conditions,
including acute asthma exacerbations and COPD. Critical
Therapeutics is aware, for instance, of clinical data available
in publications of clinical trials and individual patient case
studies that indicate zileuton has shown efficacy in the
treatment of nasal polyps. The NIH sponsored and is funding a
clinical trial to evaluate whether using ZYFLO to treat patients
admitted to the hospital with acute exacerbations of COPD will
shorten their hospital stay. The clinical trial began in
September 2007 and is being conducted by the COPD Clinical
Research Network. In each case, if Critical Therapeutics
develops zileuton for one of these diseases or conditions, it
will need to commence clinical development programs to generate
sufficient information to obtain regulatory approval.
R(+)
Isomer of Zileuton
In April 2008, Critical Therapeutics announced the results of a
Phase I clinical trial to assess the safety and tolerability of
an oral single dose of the R(+) isomer of zileuton. R(+)
zileuton combined in equal proportion with its mirror image
isomer, S(−) zileuton, comprise racemic zileuton. The
trial was designed to examine the safety, tolerability,
pharmacokinetic and pharmacodynamic profile of the R(+) isomer
of zileuton in healthy subjects. The randomized, open-label,
single dose, single center, two-period crossover trial enrolled
12 participants. Each trial participant received both
100 mg and 300 mg doses of the R(+) isomer of zileuton
in a randomized, crossover design. Both dose levels of R(+)
zileuton were well tolerated with no serious adverse events or
clinical safety concerns reported in this trial. Pharmacokinetic
data obtained for R(+) zileuton, dosed alone to humans for the
first time, exhibited dose proportionality and matched
historical data obtained for R(+) zileuton following equivalent
doses of racemic zileuton in earlier clinical trials. The
pharmacokinetic profile of R(+) zileuton obtained in this trial
confirmed that it constitutes approximately two-thirds of the
plasma exposure observed with racemic zileuton and is the more
persistent isomer of zileuton.
Critical Therapeutics was not able to gain any pharmacodynamic
data from this trial. In previous in vitro preclinical
studies conducted by Critical Therapeutics with human whole
blood, R(+) zileuton exhibited higher potency for leukotriene
synthesis inhibition than S(−) zileuton indicating that
this enantiomer exhibits a more prolonged plasma pharmacokinetic
exposure profile. Critical Therapeutics believes that these
features may offer the opportunity for the development of a
product candidate with a reduced tablet size or less frequent
dose administration.
167
Critical
Care: The Inflammatory Response
Critical Therapeutics is developing product candidates directed
towards reducing the potent inflammatory response that it
believes is associated with the pathology, morbidity and, in
some cases, mortality in many acute and chronic diseases.
Critical Therapeutics early-stage product development
programs center on controlling the production of potent
inflammatory mediators that play a key role in regulating the
bodys immune system. The cascading release of the
inflammatory mediators that occurs in many disease settings
leads, in large part, to the uncontrolled, pathologic
inflammation that can occur in trauma, infection and autoimmune
and allergic diseases. Critical Therapeutics believes that this
cascade plays an important role in the severe inflammatory
response seen in:
|
|
|
|
|
acute diseases and conditions that lead to admission to the
intensive care unit, or ICU, such as sepsis and septic
shock; and
|
|
|
|
acute exacerbations of chronic diseases that frequently lead to
hospitalization, such as asthma, lupus and rheumatoid arthritis.
|
In the setting of severe infection, trauma, severe bleeding or a
lack of oxygen to the major organs of the body, the
overproduction of inflammatory mediators, including cytokines,
can lead to organ failure, tissue destruction and, eventually,
death. When cytokine levels become elevated, an excessive
inflammatory response occurs that may potentially result in
damage to vital internal organs and, in the most severe cases,
multiple organ failure and death. Many previous therapies
directed at cytokines, such as tumor necrosis factor alpha, or
TNF alpha, in acute diseases have failed in clinical development.
The individual programs within Critical Therapeutics
portfolio, while targeted toward the inflammatory response,
exert their effects through different mechanisms of action.
These programs include:
|
|
|
|
|
an alpha-7 program directed towards a receptor that Critical
Therapeutics believes regulates the release of the cytokines
that play a fundamental role in the inflammatory response,
including TNF alpha, in response to an inflammatory
stimulus; and
|
|
|
|
an HMGB1 program directed towards the pro-inflammatory protein
HMGB1.
|
These programs are described in more detail below.
Alpha-7
Program
Stimulation of the vagus nerve, a nerve that links the brain
with the major organs of the body, causes the release of a
chemical neurotransmitter called acetylcholine. Acetylcholine
has been shown to inhibit the release of cytokines that play a
fundamental role in the inflammatory response, including TNF
alpha. Research indicates that acetylcholine exerts
anti-inflammatory activity by stimulating alpha-7 receptor on
cells involved in the inflammatory process.
Historically, a number of companies have focused on the alpha-7
receptor target for the treatment of central nervous system
diseases. Critical Therapeutics believes the discovery of the
role of this receptor in inflammation has led to a new
opportunity for the development of products to treat diseases in
which inflammation plays a role. Critical Therapeutics is
undertaking a program to develop a small molecule product
candidate that inhibits the inflammatory response by stimulating
the alpha-7 receptor on human inflammatory cells.
Therapeutic
Opportunity
Critical Therapeutics successful development of a product
candidate targeting the alpha-7 receptor could lead to a novel
treatment for severe acute inflammatory disease, as well as an
oral anti-cytokine therapy that could be directed at chronic
inflammatory diseases such as asthma, rheumatoid arthritis and
Crohns disease. Critical Therapeutics believes the
previous work on the alpha-7 receptor will assist the discovery
of new, peripherally acting drugs that selectively stimulate the
alpha-7 receptor. Critical Therapeutics believes a drug
candidate taken orally could have a strong market position
against current injectable anti-TNF alpha biological therapies,
168
particularly if it avoids the potential immunological response
to therapy, which is a known risk with antibody products.
Development
Strategy
Critical Therapeutics is currently completing preclinical
evaluations of proprietary small molecule product candidates in
its alpha-7 program. Critical Therapeutics has seen positive
results with its molecules in animal models of allergic lung
inflammation and acute lung injury, including models using
alpha-7 knock-out mice. Critical Therapeutics believes the
initial results support the concept that the alpha-7 receptor
plays an important role in modulating the severity of
inflammation in these models and that Critical
Therapeutics molecules work by stimulating this receptor.
Critical Therapeutics has selected both a lead and a backup
molecule, and it believes both have shown promising preclinical
pharmacology and non-GLP toxicology results. Critical
Therapeutics moved the lead molecule into GLP toxicology
evaluations in 2008. Provided the data are supportive and
sufficient resources are available, Critical Therapeutics
believes that an IND could be filed in 2009. Critical
Therapeutics plans to seek a collaborator for its alpha-7
program to develop and commercialize possible product candidates
in multiple development opportunities that may exist for this
program prior to initiation of human clinical trials.
HMGB1
Program
Critical Therapeutics is evaluating mechanisms to prevent HMGB1
from effecting its role in inflammation-mediated diseases. HMGB1
has been identified as a potential late mediator of
inflammation-induced tissue damage. Unlike other previously
identified cytokines, such as interleukin-1 and TNF alpha, HMGB1
is expressed much later in the inflammatory response and
persists at elevated levels in the bloodstream for a longer time
period. Critical Therapeutics believes, therefore, that HMGB1 is
a unique target for the development of products to treat
inflammation-mediated diseases.
In 2003, Critical Therapeutics entered into an exclusive license
and collaboration agreement with MedImmune to jointly develop
and commercialize therapeutic products directed towards blocking
the pro-inflammatory activity of HMGB1. In January 2005,
Critical Therapeutics entered into a collaboration with Beckman
Coulter to develop a diagnostic assay that could be used to
identify which patients have elevated levels of HMGB1 and would,
therefore, be most likely to respond to anti-HMGB1 therapy.
As part of the MedImmune collaboration, the research programs
are currently aimed at generating antibodies that can neutralize
circulating HMGB1 prior to it binding to its receptor. Fully
human antibodies directed towards HMGB1, including fully human
antibodies identified as part of the MedImmune collaboration,
are currently in preclinical development. In December 2005,
MedImmune agreed that proof of concept had been achieved for two
preclinical models with human anti-HMGB1 monoclonal antibodies.
These antibodies are now undergoing further evaluation with the
goal of selecting candidates for use in clinical testing.
Therapeutic
Opportunity
Critical Therapeutics believes that HMGB1s delayed and
prolonged expression offers a new target for the development of
products for acute diseases that can result in multiple organ
failure, including sepsis and septic shock, and acute
exacerbations of chronic diseases associated with the
inflammatory response mediated by cytokines, such as rheumatoid
arthritis and lupus.
Sepsis is the bodys systemic inflammatory response to
infection or trauma. In animal models relating to septic shock,
monoclonal antibodies targeting HMGB1 were successful in
significantly reducing the mortality rate associated with these
models. To date, limited clinical investigations have identified
that patients with sepsis have elevated levels of HMGB1 in their
bloodstream, compared to normal individuals, who do not have
detectable levels of HMGB1 in their bloodstream. The elevated
HMGB1 levels appeared to be greatest in the patients who
subsequently died as a result of their disease.
Similar treatment opportunities also exist with other diseases
that include an HMGB1 component, such as rheumatoid arthritis.
Elevated levels of HMGB1 have been observed in the synovial
fluid in the joints of
169
rheumatoid arthritis patients, and positive symptom responses
have been achieved in animal models of rheumatoid arthritis with
anti-HMGB1 therapy. Human monoclonal antibodies jointly
generated by the collaboration with MedImmune have demonstrated
promising activity in assays and animal models with relevance to
clinical arthritis and lupus.
Clinical
Strategy
Critical Therapeutics has generated a number of fully human
antibodies that bind to HMGB1 and that are active in vitro
and in vivo. A number of these antibodies have demonstrated a
dose-dependent benefit on survival in a mouse model of sepsis
and a reduction in clinical arthritis symptoms in mouse and rat
models of arthritis. In some of these tests, the monoclonal
antibodies were administered in a treatment model after disease
onset, as opposed to the preventive model in which the drug is
administered before disease onset.
The research phase of the collaboration with MedImmune has ended
and, under the collaboration agreement, MedImmune is responsible
for conducting programs necessary to advance potential product
candidates into Phase I clinical trials. As of
September 15, 2008, no decision to select a clinical
candidate has been made.
Collaborations
Zileuton
Co-Promotion Agreement with DEY
On March 13, 2007, Critical Therapeutics entered into an
agreement with DEY under which Critical Therapeutics and DEY
agreed to jointly co-promote ZYFLO and, after approval by the
FDA, ZYFLO CR. Under the co-promotion and marketing services
agreement, Critical Therapeutics granted DEY an exclusive right
and license or sublicense, under patent rights controlled by
Critical Therapeutics, to promote and detail ZYFLO and ZYFLO CR
in the United States, together with Critical Therapeutics and
its affiliates, for asthma and, subject to FDA approval, other
respiratory conditions.
Both Critical Therapeutics and DEY have agreed to use diligent
efforts to promote the applicable products in the United States
during the term of the co-promotion agreement. In addition, DEY
has agreed to provide a minimum number of details per month for
ZYFLO CR in the second position to office-based physicians and
other health care professionals, including a minimum number of
details delivered to respiratory specialists, such as allergists
and pulmonologists. Critical Therapeutics has agreed to provide
a minimum number of details per month for ZYFLO CR in the first
position. From 2008 through 2010, Critical Therapeutics and DEY
each have agreed to contribute 50% of approved out-of-pocket
promotional expenses for ZYFLO CR that are accrued or paid to
third-parties. Critical Therapeutics and DEY each have agreed to
contribute a minimum of $3.0 million per year for these
promotional expenses. Critical Therapeutics was responsible for
third-party promotional costs during 2007.
Under the co-promotion agreement, DEY paid Critical Therapeutics
in 2007 a non-refundable upfront payment of $3.0 million
upon signing the co-promotion agreement, non-refundable
milestone payments of $4.0 million following approval by
the FDA of the NDA for ZYFLO CR and $5.0 million following
commercial launch of ZYFLO CR. Critical Therapeutics, in
accordance with Emerging Issues Task Force, or EITF, Issue
No. 02-16,
Accounting for Consideration Received from a Vendor by a
Customer (Including a Reseller of the Vendors Products),
or EITF
02-16, has
deferred the $12.0 million in aggregate payments received
to date and is amortizing these payments over the term of the
agreement. The amortization of the upfront and milestone
payments will be offset by the co-promotion fees paid to DEY for
promoting ZYFLO and ZYFLO CR. Critical Therapeutics records any
co-promotion fees paid to DEY and the amortization of the
upfront and milestone payments as sales and marketing expenses.
Under the co-promotion agreement, Critical Therapeutics records
all quarterly net sales of ZYFLO and ZYFLO CR, after third-party
royalties, up to $1.95 million. Critical Therapeutics pays
DEY a portion of quarterly net sales of ZYFLO and ZYFLO CR,
after third-party royalties, in excess of $1.95 million.
From the date DEY began detailing ZYFLO through the commercial
launch of ZYFLO CR in September 2007, Critical Therapeutics
agreed to pay DEY 70% of quarterly net sales of ZYFLO and ZYFLO
CR, after third-party royalties, in excess of
$1.95 million. Following the commercial launch of ZYFLO CR
in September 2007
170
through December 31, 2010, Critical Therapeutics has agreed
to pay DEY 35% of quarterly net sales of ZYFLO and ZYFLO CR,
after third-party royalties, in excess of $1.95 million.
From January 1, 2011 through December 31, 2013,
Critical Therapeutics has agreed to pay DEY 20% of quarterly net
sales of ZYFLO and ZYFLO CR, after third-party royalties, in
excess of $1.95 million. For the year ended
December 31, 2007 and for the six months ended
June 30, 2008, Critical Therapeutics paid $0 and $385,000,
respectively, in co-promotion fees to DEY. At December 31,
2007 and June 30, 2008, Critical Therapeutics had $680,000
and $978,000, respectively, included in accrued expenses related
to co-promotion fees owed to DEY.
The co-promotion agreement has a term expiring on
December 31, 2013, which may be extended upon mutual
agreement by the parties. Beginning September 25, 2010,
either party may terminate the co-promotion agreement with
six-months advance written notice. In addition, DEY has
the right to terminate the
co-promotion
agreement with two-months prior written notice if ZYFLO CR
cumulative net sales for any four consecutive calendar quarters
after commercial launch of ZYFLO CR are less than
$25 million. Each party has the right to terminate the
co-promotion agreement upon the occurrence of a material uncured
breach by the other party.
DEY has agreed not to manufacture, detail, sell, market or
promote any product containing zileuton as one of the APIs for
sale in the United States until the later of one year after
expiration or termination of the
co-promotion
agreement and March 15, 2012. However, if an AB-rated
generic product to ZYFLO CR is introduced, DEY would not be
subject to these non-competition obligations, and DEY will have
the exclusive right to market the authorized generic version of
ZYFLO CR. DEY also will not be subject to these non-competition
obligations if DEY terminates the co-promotion agreement either
because ZYFLO CR cumulative net sales for any four consecutive
calendar quarters after commercial launch of ZYFLO CR are less
than $25 million or upon the occurrence of a material
uncured breach by Critical Therapeutics.
During the term of the co-promotion agreement, a joint
commercial committee with two members from Critical Therapeutics
and two members from DEY oversees co-promotion activities under
the co-promotion agreement. The co-promotion agreement provides
that the joint commercial committee will make decisions by
unanimous agreement, with disagreements being referred for
resolution by the Chief Executive Officer of each party and
further disputes being subject to non-binding mediation.
PERFOROMIST
Co-Promotion Agreement with DEY
On June 25, 2007, Critical Therapeutics entered into a
co-promotion agreement with DEY relating to PERFOROMIST,
DEYs product for the treatment of COPD. Under the
co-promotion agreement, DEY granted Critical Therapeutics a
right and license or sublicense to promote and detail
PERFOROMIST in the United States, together with DEY. The
co-promotion agreement supersedes a binding letter agreement
between DEY and Critical Therapeutics dated March 13, 2007
relating to the co-promotion of PERFOROMIST. On July 2,
2008, Critical Therapeutics provided notice to DEY that Critical
Therapeutics had exercised its contractual right to terminate
the co-promotion agreement for PERFOROMIST. The termination is
effective September 30, 2008.
Both Critical Therapeutics and DEY have agreed to use diligent
efforts to promote PERFOROMIST in the United States during the
term of the co-promotion agreement. In addition, Critical
Therapeutics has agreed to provide a minimum number of primary
detail equivalents per month for PERFOROMIST to a specified
group of office-based physicians and other health care
professionals. Critical Therapeutics is responsible for its own
sales force expenses, including the cost of promotional
materials used by its sales force. Under this co-promotion
agreement, DEY has agreed to pay Critical Therapeutics a
co-promotion fee under a calculation based on retail sales of
PERFOROMIST.
During the term of this co-promotion agreement and for a period
of one year after the expiration or termination of the
co-promotion agreement, Critical Therapeutics has agreed not to
manufacture, detail, sell, market or promote in the United
States any product containing forms or derivatives of
formoterol, or FAPI, as one of the APIs for PERFOROMISTs
approved indications, other than PERFOROMIST, during the term of
the co-promotion agreement. Notwithstanding the foregoing, if
Critical Therapeutics signs a definitive agreement to be
acquired by or merged with a third party that markets,
manufactures, sells, details or
171
promotes a product containing FAPI for sale in the United
States, then, in lieu of the foregoing non-competition
provision, Critical Therapeutics has agreed to specified
restrictions on the activities of its sales representatives for
a specified
180-day
period.
If Critical Therapeutics signs a definitive agreement to be
acquired by or merged with a third party that markets,
manufactures, sells, details or promotes a product containing
FAPI for sale in the United States, each party will have the
right to terminate the co-promotion agreement with three
business days advance written notice. Each party has the right
to terminate the co-promotion agreement upon the occurrence of a
material uncured breach by the other party.
MedImmune
Collaboration
In July 2003, Critical Therapeutics entered into an exclusive
license and collaboration agreement with MedImmune to jointly
develop products directed towards HMGB1. This agreement was
amended in December 2005. Under the terms of the agreement,
Critical Therapeutics granted MedImmune an exclusive worldwide
license, under patent rights and know-how controlled by Critical
Therapeutics, to make, use and sell products, including
antibodies, that bind to, inhibit or inactivate HMGB1 and are
used in the treatment or prevention, but not the diagnosis, of
diseases, disorders and medical conditions.
Critical Therapeutics and MedImmune determine the extent of the
collaboration on research and development matters each year upon
the renewal of a rolling three-year research plan. Critical
Therapeutics is currently working with MedImmune to evaluate the
potential of a series of fully human monoclonal antibodies as
agents for development as therapeutic antibodies to enable them
to enter clinical development. Under the terms of the agreement,
MedImmune agreed to fund and expend efforts to research and
develop at least one
HMGB1-inhibiting
product for two indications through specified clinical phases.
Under the agreement, Critical Therapeutics was required to
perform certain research activities under an agreed upon
research plan that ended in 2007. During the term of the
research plan, Critical Therapeutics received research funding
from MedImmune based on the number of full-time equivalents
employed by Critical Therapeutics for purposes of executing the
research plan. All payments made to Critical Therapeutics under
the agreement are non-refundable. In connection with the
research portion of the agreement, Critical Therapeutics
recorded $17.9 million in revenue over the
47-month
term. The payments included $12.5 million in upfront
license fees and research funding, which was paid in two
installments of $10.0 million in late 2003 and
$2.5 million in early 2004; $1.3 million for the
achievement of a specified research milestone in early 2005; and
$4.1 million in payments for research work performed by
Critical Therapeutics. No performance is required of Critical
Therapeutics subsequent to the research period and MedImmune is
responsible for subsequent product development and
commercialization. Under the agreement, Critical Therapeutics
may receive, subject to the terms and conditions of the
agreement, other payments upon the achievement of development
and commercialization milestones by MedImmune up to a maximum of
$124.0 million, after taking into account payments that
Critical Therapeutics is obligated to make to The Feinstein
Institute for Medical Research (formerly known as The North
Shore-Long Island Jewish Research Institute), or The Feinstein
Institute. Critical Therapeutics has not recorded and will not
record these future development and commercialization milestones
until they are achieved. MedImmune also has agreed to pay
royalties to Critical Therapeutics based upon net sales by
MedImmune of licensed products resulting from the collaboration.
MedImmunes obligation to pay Critical Therapeutics
royalties continues on a
product-by-product
and
country-by-country
basis until the later of 10 years from the first commercial
sale of a licensed product in each country and the expiration of
the patent rights covering the product in that country. Critical
Therapeutics is obligated to pay a portion of any milestone
payments or royalties Critical Therapeutics receives from
MedImmune to The Feinstein Institute, which initially licensed
to Critical Therapeutics patent rights and know-how related to
HMGB1. In connection with entering into the collaboration
agreement, an affiliate of MedImmune purchased an aggregate of
$15.0 million of Critical Therapeutics series B
convertible preferred stock in October 2003 and March 2004,
which converted into 2,857,142 shares of Critical
Therapeutics common stock in June 2004 in connection with
Critical Therapeutics initial public offering.
In December 2005, MedImmune agreed that the collaboration
demonstrated proof of concept in two preclinical disease models
with human HMGB1 monoclonal antibodies. As a result, MedImmune
made a $1.25 million milestone payment to Critical
Therapeutics. In December 2005, MedImmune agreed to fund an
172
additional $1.0 million of research work performed by
Critical Therapeutics full-time employees in 2006. In
March 2007, MedImmune agreed to fund an additional $125,000
of research work performed by Critical Therapeutics
full-time employees in 2007.
Critical Therapeutics worked exclusively with MedImmune in the
research and development of HMGB1-inhibiting products through
the first half of 2007. Since then, MedImmune has assumed full
responsibility for all of the research and development efforts
related to the program. Under the terms of the agreement,
MedImmunes license to commercialize HMGB1-inhibiting
products generally excludes Critical Therapeutics from
manufacturing, promoting or selling the licensed products.
However, Critical Therapeutics has the option to co-promote in
the United States the first product for the first indication
approved in the United States, for which Critical Therapeutics
must pay a portion of the ongoing development costs and will
receive a proportion of the profits in lieu of royalties that
would otherwise be owed to Critical Therapeutics. MedImmune has
the right to terminate Critical Therapeutics co-promotion
option in connection with a change of control of Critical
Therapeutics. MedImmune has informed Critical Therapeutics that
it is terminating Critical Therapeutics co-promotion
rights in connection with the merger with Cornerstone.
MedImmune has the right to terminate the agreement at any time
on six-months written notice. Each party has the right to
terminate the agreement upon the occurrence of a material
uncured breach by the other party. Under specified conditions,
Critical Therapeutics or MedImmune may have certain payment or
royalty obligations after the termination of the agreement.
Beckman
Coulter Collaboration
In January 2005, Critical Therapeutics entered into a license
agreement with Beckman Coulter relating to the development of
diagnostic products for measuring HMGB1. Under the terms of the
agreement, Critical Therapeutics granted to Beckman Coulter and
its affiliates an exclusive worldwide license, under patent
rights and know-how controlled by Critical Therapeutics relating
to the use of HMGB1 and its antibodies in diagnostics, to
evaluate, develop, make, use and sell a kit or assemblage of
reagents for measuring HMGB1 that utilizes one or more
monoclonal antibodies to HMGB1 developed by Critical
Therapeutics or on its behalf.
In consideration for the license, Beckman Coulter paid Critical
Therapeutics a product evaluation license fee of $250,000.
Beckman Coulter exercised its development option under the
license agreement in December 2006 and paid Critical
Therapeutics $400,000 in January 2007. Under the agreement,
Critical Therapeutics may also receive additional aggregate
license fees of up to $450,000 upon the achievement of the first
commercial sale of a licensed product. Beckman Coulter also
agreed to pay Critical Therapeutics royalties based on net sales
of licensed products by Beckman Coulter and its affiliates.
Beckman Coulter has the right to grant sublicenses under the
license, subject to Critical Therapeutics written consent,
which Critical Therapeutics has agreed not to unreasonably
withhold. In addition, Beckman Coulter agreed to pay Critical
Therapeutics a percentage of any license fees, milestone
payments or royalties actually received by Beckman Coulter from
its sublicensees.
Beckman Coulter has the right to terminate the license agreement
at any time on
90-days
written notice. Each party has the right to terminate the
license agreement upon the occurrence of a material uncured
breach by the other party.
Development
As of September 15, 2008, Critical Therapeutics had two
employees engaged in development and regulatory activities.
During the six months ended June 30, 2008 and the fiscal
years ended December 31, 2007, 2006 and 2005, research and
development expenses were $6.9 million, $21.7 million,
$26.9 million and $30.0 million, respectively.
Sales and
Marketing
Critical Therapeutics has a respiratory sales force of
approximately 26 representatives as of September 15, 2008,
who are focused on promoting ZYFLO CR and PERFOROMIST to
prescribing physicians within major markets across the United
States. Under Critical Therapeutics co-promotion agreement
with DEY, DEY has
173
agreed to provide a minimum number of details per month for in
the second position to office-based physicians and other health
care professionals, including a minimum number of details
delivered to respiratory specialists, such as allergists and
pulmonologists. Critical Therapeutics has agreed to provide a
minimum number of details per month for ZYFLO CR in the first
position. In addition, under the co-promotion agreement with DEY
for PERFOROMIST, Critical Therapeutics has agreed to provide a
minimum number of primary detail equivalents per month for
PERFOROMIST to a specified group of office-based physicians and
other health care professionals. On July 2, 2008, Critical
Therapeutics provided notice to DEY that Critical Therapeutics
had exercised its contractual right to terminate the
co-promotion agreement for PERFOROMIST. The termination is
effective September 30, 2008.
Critical Therapeutics is focusing its sales and marketing
efforts for ZYFLO CR on respiratory specialists who treat
asthma, including allergists and pulmonologists, and primary
care physicians who treat large numbers of asthma patients.
Critical Therapeutics believes that within this targeted group
there are approximately 100 to 200 national and regional
scientific and clinical key opinion leaders who serve to
influence the direction of the diagnosis and treatment of asthma
through their publications and presentations at scientific and
clinical medical conferences. Critical Therapeutics also expects
to focus its medical outreach efforts on local, clinically-based
key opinion leaders.
Given the importance of the scientific and clinical key opinion
leaders, Critical Therapeutics is directing its scientific
message and support to help educate and inform key opinion
leaders regarding the scientific rationale and clinical data
that support its commercialization strategy. Critical
Therapeutics has entered into consulting arrangements with a
number of key opinion leaders who provide expert advice
to it.
In June 2007, the NHLBI released an updated version of the
Guidelines for the Diagnosis and Management of Asthma. In these
guidelines, zileuton is specifically mentioned in steps three
and four in the treatment spectrum as an alternative option in
the treatment of asthma. This is the first time zileuton has
been mentioned in these guidelines, and Critical Therapeutics
believes this may provide additional scientific credibility to
ZYFLO CR in the marketplace. In addition to the changes in the
recommended treatment protocol for asthma, the updated
guidelines continue to support the transition to the discussion
of asthmatic patients in terms of their level of control rather
than their severity level.
Manufacturing
and Supply
Critical Therapeutics has limited experience in manufacturing
its products and product candidates. Critical Therapeutics
currently outsources the manufacturing of ZYFLO CR and ZYFLO for
commercial sale and the manufacturing of its product candidates
for use in clinical trials to qualified third parties and
intends to continue to rely on contract manufacturing from third
parties to supply products for both clinical use and commercial
sale.
In January 2008, Critical Therapeutics requested and received
from the FDA a waiver from the requirement to provide
six-months notice to cease manufacturing ZYFLO. In
February 2008, Critical Therapeutics stopped the manufacture and
supply of ZYFLO to the market. In March 2008, Critical
Therapeutics began to experience supply chain issues with ZYFLO
CR. In the quarter ended June 30, 2008, Critical
Therapeutics recorded an inventory reserve with respect to an
aggregate of eight batches of ZYFLO CR that could not be
released into Critical Therapeutics commercial supply
chain, consisting of one batch of ZYFLO CR that did not meet
Critical Therapeutics product release specifications and
an additional seven batches of ZYFLO CR that were on quality
assurance hold and that could not complete manufacturing within
the NDA-specified manufacturing timelines. In the quarters ended
December 31, 2007 and March 31, 2008, Critical
Therapeutics recorded inventory reserves with respect to an
aggregate of eight batches of ZYFLO CR that could not be
released into Critical Therapeutics commercial supply
chain because they did not meet Critical Therapeutics
product release specifications. In conjunction with Critical
Therapeutics three third-party manufacturers for zileuton
API, tablet cores and coating and release, Critical Therapeutics
has initiated an investigation to determine the cause of this
issue, but the investigation is ongoing and is not yet complete.
Critical Therapeutics has incurred and expects to continue to
incur significant costs in connection with its investigation. To
date, the investigation has not identified a clear source of the
issue. In August and September
174
2008, Critical Therapeutics released and made available for
shipment to wholesale distributors an aggregate of six batches
of finished ZYFLO CR tablets that met its product release
specifications. Critical Therapeutics is currently unable to
accurately assess the timing and quantity of future batches of
ZYFLO CR, if any, that may be released for commercial supply. If
not corrected, the ongoing supply chain difficulties could
prevent Critical Therapeutics from supplying any further product
to its wholesale distributors. Based on its current level of
sales and the release of the six batches of ZYFLO CR in August
and September 2008, Critical Therapeutics estimates that
wholesale distributors and retail pharmacies will have a
sufficient inventory of ZYFLO CR to continue to provide product
to patients through the fourth quarter of 2008.
In April 2008, Critical Therapeutics began to reinitiate
manufacture of ZYFLO in order to have a supply of ZYFLO
available to reinitiate marketing and supply of ZYFLO to the
market given the supply chain issues being experienced for ZYFLO
CR. In September 2008, Critical Therapeutics resumed
distribution of ZYFLO to help manage any potential impact to
patients of supply chain issues for ZYFLO CR.
Critical Therapeutics has established the following
manufacturing arrangements for zileuton.
Shasun
Pharma Solutions
Critical Therapeutics originally contracted with Rhodia Pharma
Solutions Ltd. for the commercial production of the zileuton
API. On March 31, 2006, Rhodia SA, the parent company of
Rhodia Pharma Solutions, sold the European assets of its
pharmaceutical custom synthesis business to Shasun Chemicals and
Drugs Ltd. As part of this transaction, Rhodia SA assigned
Critical Therapeutics contract with Rhodia Pharma
Solutions Ltd. to Shasun. Under Critical Therapeutics
agreement with Shasun, as amended, Shasun has agreed to
manufacture Critical Therapeutics commercial supplies of
API, subject to specified limitations, through the earlier of
the date on which Critical Therapeutics has purchased a
specified amount of the API for zileuton and December 31,
2010. Critical Therapeutics has committed to purchase a minimum
amount of zileuton API from Shasun of $2.0 million in 2008 and
$2.0 million in 2009, although Critical Therapeutics has the
right to reduce by $1.3 million the amount of zileuton API it
must purchase in 2009 by providing written notice to Shasun no
later than December 31, 2008. The API purchased from Shasun
currently has a shelf-life of 36 months. The agreement will
automatically extend for successive one-year periods after
December 31, 2010, unless Shasun provides Critical
Therapeutics with
18-months
prior written notice of cancellation. Critical Therapeutics has
the right to terminate the agreement upon
12-months
prior written notice for any reason, provided that Critical
Therapeutics may not cancel prior to the earlier of
December 31, 2010 or the date on which it has purchased a
specified amount of the API. Critical Therapeutics also has the
right to terminate the agreement upon six-months prior
written notice if it terminates its plans to commercialize
zileuton for all therapeutic indications. In addition, Critical
Therapeutics has the right to terminate the agreement upon
30-days
prior written notice if any governmental agency takes any
action, or raises any objection, that prevents Critical
Therapeutics from importing, exporting, or selling zileuton
products or the API. If Critical Therapeutics exercises its
right to terminate the agreement prior to its scheduled
expiration, Critical Therapeutics is obligated to reimburse
Shasun for specified raw material and out-of-pocket costs. In
addition, if Critical Therapeutics exercises its right to
terminate the agreement due to termination of Critical
Therapeutics plans to commercialize zileuton for all
therapeutic indications, then Critical Therapeutics is also
obligated to pay Shasun for all API manufactured by Shasun
through that date. Furthermore, each party has the right to
immediately terminate the agreement for cause, including a
material uncured default by the other party.
Jagotec
Critical Therapeutics has contracted with Jagotec for the
manufacture and supply of bulk, uncoated tablets of ZYFLO CR for
Critical Therapeutics for commercial sale. Critical Therapeutics
has agreed to purchase minimum quantities of ZYFLO CR during
each
12-month
period for the first five years following marketing approval of
ZYFLO CR by the FDA. For the term of the contract, Critical
Therapeutics has agreed to purchase specified amounts of its
requirements for ZYFLO CR from Jagotec. Critical Therapeutics
has committed to purchase a minimum of 20 million ZYFLO CR
tablet cores from Jagotec in each of the four 12-month periods
starting May 30, 2008. The commercial manufacturing agreement
has an initial term of five
175
years beginning on May 22, 2007, and will automatically
continue thereafter, unless Critical Therapeutics provides
Jagotec with
24-months
prior written notice of termination or Jagotec provides Critical
Therapeutics with
36-months
prior written notice of termination. In addition, Critical
Therapeutics has the right to terminate the agreement upon
30-days
prior written notice in the event any governmental agency takes
any action, or raises any objection, that prevents Critical
Therapeutics from importing, exporting or selling ZYFLO CR.
Critical Therapeutics also may terminate the agreement upon
six-months advance notice in the event that an AB-rated
generic pharmaceutical product containing zileuton is introduced
in the United States and Critical Therapeutics determines to
permanently cease commercialization of ZYFLO CR. Likewise,
Critical Therapeutics may terminate the agreement upon
12-months
advance notice if it intends to discontinue commercializing
ZYFLO CR tablets. Furthermore, each party has the right to
terminate the agreement upon the occurrence of a material
uncured breach by the other party. In the event either party
terminates the agreement, Critical Therapeutics agreed to
purchase quantities of ZYFLO CR tablets that are subject to
binding forecasts.
Patheon
Pharmaceuticals
Critical Therapeutics has contracted with Patheon to coat,
conduct quality control and quality assurance and stability
testing and package commercial supplies of ZYFLO CR. Under this
agreement, Critical Therapeutics is responsible for supplying
uncoated ZYFLO CR tablets to Patheon. Critical Therapeutics has
agreed to purchase at least 50% of its requirements for such
manufacturing services for ZYFLO CR for sale in the United
States from Patheon each year during the term of this agreement.
This agreement has an initial term of three years beginning
May 9, 2007, and will automatically continue for successive
one-year periods thereafter, unless Critical Therapeutics
provides Patheon with
12-months
prior written notice of termination or Patheon provides Critical
Therapeutics with
18-months
prior written notice of termination. In addition, Critical
Therapeutics has the right to terminate this agreement upon
30-days
prior written notice in the event that any governmental agency
takes any action, or raises any objection, that prevents
Critical Therapeutics from importing, exporting, purchasing or
selling ZYFLO CR. Critical Therapeutics also has the right to
terminate this agreement upon
90-days
prior written notice if an AB-rated generic product to ZYFLO CR
is introduced in the United States. If Critical Therapeutics
provides six-months advance notice that it intends to
discontinue commercializing ZYFLO CR, Critical Therapeutics will
not be required to purchase any additional quantities of ZYFLO
CR finished tablets from Patheon, provided that Critical
Therapeutics pays Patheon for a portion of specified fees and
expenses associated with orders Critical Therapeutics previously
placed. Patheon has the right to terminate this agreement if
Critical Therapeutics assigns any of Critical Therapeutics
rights under the agreement to an assignee other than a purchaser
or merger partner that, in Patheons reasonable opinion, is
not a credit worthy substitute for Critical Therapeutics, is a
competitor of Patheon or is an entity with whom Patheon has had
prior unsatisfactory business relations. Furthermore, each party
has the right to terminate this agreement upon the occurrence of
a material uncured breach by the other party. If this agreement
expires or is terminated for any reason, Critical Therapeutics
has agreed to take delivery of and pay for undelivered
quantities of ZYFLO CR that it previously ordered, purchase, at
cost, Patheons inventory of ZYFLO CR maintained in
contemplation of filling orders previously placed by Critical
Therapeutics and pay the purchase price for components ordered
by Patheon from suppliers in reliance on orders Critical
Therapeutics previously placed.
Critical Therapeutics has contracted with Patheon for the
manufacture of commercial supplies of ZYFLO immediate release
tablets. Critical Therapeutics has agreed to purchase at least
50% of its commercial supplies of ZYFLO immediate-release
tablets for sale in the United States from Patheon each year for
the term of the agreement. The commercial manufacturing
agreement has an initial term of three years beginning on
September 15, 2005, and will automatically continue for
successive one-year periods thereafter, unless Critical
Therapeutics provides Patheon with
12-months
prior written notice of termination or Patheon provides Critical
Therapeutics with
18-months
prior written notice of termination. In addition, Critical
Therapeutics has the right to terminate the agreement upon
30-days
prior written notice in the event any governmental agency takes
any action, or raises any objection, that prevents it from
importing, exporting, purchasing or selling ZYFLO. If Critical
Therapeutics provides six-months advance notice that it
intends to discontinue commercializing ZYFLO, Critical
Therapeutics will not be required to purchase any additional
quantities of
176
ZYFLO immediate release tablets, provided that it must pay
Patheon for a portion of specified fees and expenses associated
with orders previously placed by Critical Therapeutics.
Furthermore, each party has the right to terminate the agreement
upon the occurrence of a material uncured breach by the other
party. If the agreement expires or is terminated for any reason,
Critical Therapeutics has agreed to take delivery of and pay for
undelivered quantities of ZYFLO that it previously ordered,
purchase, at cost, Patheons inventory of ZYFLO maintained
in contemplation of filling orders previously placed by Critical
Therapeutics and pay the purchase price for components of the
ZYFLO immediate release tablets ordered by Patheon from
suppliers in reliance on orders previously placed by Critical
Therapeutics.
CyDex
Critical Therapeutics has entered into a license and supply
agreement with CyDex, Inc., or CyDex, relating to Critical
Therapeutics clinical development and planned
commercialization of zileuton injection. Under this agreement,
CyDex granted to Critical Therapeutics a worldwide, exclusive
license, under patent rights controlled by CyDex relating to
CyDexs
CAPTISOL®
drug enablement technology, for use with zileuton, under which
Critical Therapeutics can develop, make, use and sell zileuton
combined with or formulated using CAPTISOL in an injectable
dosage form for ultimate use in humans. In addition, CyDex
granted Critical Therapeutics a worldwide, non-exclusive license
to utilize CyDexs toxicology and safety and other relevant
scientific data, relating to CAPTISOL, to develop, make, use and
sell in combination with zileuton. Under this agreement,
Critical Therapeutics agreed that it and its affiliates and
sublicensees will purchase CAPTISOL exclusively from CyDex, and
CyDex has agreed to supply 100% of Critical Therapeutics and its
affiliates and sublicensees requirements for
CAPTISOL up to a specified amount per year during the term of
the agreement.
In consideration for the licenses granted to Critical
Therapeutics under the agreement, Critical Therapeutics paid
CyDex an initial license fee of $50,000 and agreed to make
aggregate milestone payments of up to $2.9 million upon the
achievement of specified development, regulatory and
commercialization milestones for the combined product. In
addition, Critical Therapeutics agreed to pay royalties to CyDex
based on net sales of the combined product by Critical
Therapeutics and its affiliates and licensees. Critical
Therapeutics obligation to pay royalties expires, with
respect to each country in which the combined product is
commercialized, upon the later of the expiration of the last
relevant patent that claims CAPTISOL in such country or ten
years from the first commercial sale of the combined product in
such country.
The term of the agreement expires upon the expiration of
Critical Therapeutics obligation to pay royalties. CyDex
has the right to terminate the agreement upon the occurrence of
an uncured breach by Critical Therapeutics. Critical
Therapeutics has the right to terminate the agreement at any
time upon
75-days
prior written notice.
Other
Critical Therapeutics expects to need to enter into
manufacturing arrangements with third parties for the
manufacture of Critical Therapeutics other product
candidates for clinical use. For example, Critical Therapeutics
will need to enter into arrangements for the manufacture of
product candidates for clinical trials in its alpha-7 program.
Under Critical Therapeutics collaboration agreement with
MedImmune, MedImmune would be responsible for manufacturing any
biologic products that result from the HMGB1 program.
Distribution
Network
Critical Therapeutics currently relies on third parties to
distribute ZYFLO CR and ZYFLO to pharmacies. Critical
Therapeutics has contracted with ICS, a third-party logistics
company, to warehouse ZYFLO CR and ZYFLO and distribute it to
three primary wholesalers, AmerisourceBergen Corporation,
Cardinal Health and McKesson Corporation, and a number of
smaller wholesalers. The wholesalers, in turn, distribute it to
chain and independent pharmacies. ICS is Critical
Therapeutics exclusive supplier of commercial distribution
logistics services.
177
Critical Therapeutics relies on Phoenix to distribute samples of
ZYFLO CR and ZYFLO to Critical Therapeutics sales
representatives, who in turn distribute samples to physicians
and other prescribers who are authorized under state law to
receive and dispense samples.
This distribution network requires significant coordination with
Critical Therapeutics supply chain, sales and marketing
and finance organizations. Critical Therapeutics does not have
its own warehouse or distribution capabilities. Critical
Therapeutics does not intend to establish these functions on its
own in the foreseeable future.
License
and Royalty Agreements
Critical Therapeutics has entered into a number of license
agreements under which it has licensed intellectual property and
other rights needed to develop its products or under which
Critical Therapeutics has licensed intellectual property and
other rights to third parties, including the license agreements
summarized below.
Abbott
In December 2003, Critical Therapeutics acquired an exclusive
worldwide license, under patent rights and know-how controlled
by Abbott, to develop, make, use and sell controlled-release and
injectable formulations of zileuton for all clinical
indications, except for the treatment of children under age
seven and use in cardiovascular and vascular devices. This
license included an exclusive sublicense of Abbotts rights
in proprietary controlled-release technology originally licensed
to Abbott by Jagotec. In consideration for the license, Critical
Therapeutics paid Abbott an initial $1.5 million license
fee and agreed to make aggregate milestone payments of up to
$13.0 million to Abbott upon the achievement of various
development and commercialization milestones, including the
completion of the technology transfer from Abbott to Critical
Therapeutics, filing and approval of a product in the United
States and specified minimum net sales of licensed products. In
addition, Critical Therapeutics agreed to pay royalties to
Abbott based on net sales of licensed products by Critical
Therapeutics, its affiliates and sublicensees. Critical
Therapeutics obligation to pay royalties continues on a
country-by-country
basis for a period of ten years from the first commercial sale
of a licensed product in each country. Upon the expiration of
Critical Therapeutics obligation to pay royalties for
licensed products in a given country, the license will become
perpetual, irrevocable and fully paid up with respect to
licensed products in that country. If Critical Therapeutics
decides to sublicense rights under the license, Critical
Therapeutics must first enter into good faith negotiations with
Abbott for the commercialization rights to the licensed product.
Abbott waived its right of first negotiation with respect to
Critical Therapeutics co-promotion arrangement with DEY
for ZYFLO CR. Each party has the right to terminate the license
upon the occurrence of a material uncured breach by the other
party. Critical Therapeutics also has the right to terminate the
license at any time upon
60-days
notice to Abbott and payment of a termination fee. Through
December 31, 2007, Critical Therapeutics has paid milestone
and license payments totaling $6.5 million to Abbott under
this agreement. In addition, after the FDA approved the NDA for
ZYFLO CR in May 2007, Critical Therapeutics accrued
$2.8 million in milestone payments it owes to Abbott on the
first and second anniversary of the approval of the ZYFLO CR NDA.
In March 2004, Critical Therapeutics acquired from Abbott the
U.S. trademark
ZYFLO®
and an exclusive worldwide license, under patent rights and
know-how controlled by Abbott, to develop, make, use and sell
the immediate-release formulation of zileuton for all clinical
indications. In consideration for the license and the trademark,
Critical Therapeutics paid Abbott an initial fee of $500,000 and
a milestone payment of $750,000 upon approval of the sNDA, which
Critical Therapeutics paid in October 2005, and Critical
Therapeutics agreed to pay royalties based upon net sales of
licensed products by Critical Therapeutics, its affiliates and
sublicensees. Critical Therapeutics obligation to pay
royalties continues on a
country-by-country
basis for a period of ten years from the first commercial sale
of a licensed product in each country. Upon the expiration of
Critical Therapeutics obligation to pay royalties in a
given country, the license will become perpetual, irrevocable
and fully paid up with respect to licensed products in that
country. Each party has the right to terminate the license upon
the occurrence of a material uncured breach by the other party.
178
Baxter
In June 2004, Critical Therapeutics entered into an agreement
with Baxter Healthcare Corporation to conduct feasibility
studies to analyze the various properties of zileuton and
determine the most suitable technologies for the development of
an injectable formulation of zileuton. In the event that
Critical Therapeutics chooses to pursue the commercialization of
a specified injectable formulation developed by Baxter that is
based on the formulation technology of a third party, Baxter
granted Critical Therapeutics an exclusive, worldwide,
non-revocable license to the formulation intellectual property
in return for Critical Therapeutics agreement to pay
Baxter royalties based on net sales of that formulation.
However, Critical Therapeutics would need to finalize the
license agreement to document such license based on the agreed
financial terms, which Critical Therapeutics may not be able to
negotiate on favorable terms, if at all. It is also possible
that Critical Therapeutics may instead determine to pursue the
commercialization of an injectable formulation developed by
Baxter based on its own proprietary formulation technology. If
Critical Therapeutics determines to do so, Critical Therapeutics
would need to license from Baxter rights to that injectable
formulation. In that case, Critical Therapeutics may not be able
to negotiate a license agreement on favorable terms, if at all.
Furthermore, although Baxter has filed two U.S. patent
applications, one for the specified injectable formulation
developed by Baxter based on the formulation technology of a
third party and another for an injectable formulation developed
by Baxter based on its own proprietary formulation technology,
neither of these patent applications may result in issued
patents.
The
Feinstein Institute
In July 2001, Critical Therapeutics acquired from The Feinstein
Institute an exclusive worldwide license, under patent rights
and know-how controlled by The Feinstein Institute relating to
HMGB1, to make, use and sell products covered by the licensed
patent rights and know-how. The Feinstein Institute retained the
right to make and use the licensed products in its own
laboratories solely for non-commercial, scientific purposes and
non-commercial research. In consideration for the license,
Critical Therapeutics paid an initial license fee of $100,000.
Critical Therapeutics also agreed to make milestone payments to
The Feinstein Institute of up to $275,000 for the first product
covered by the licensed patent rights and an additional $100,000
for each additional distinguishable product covered by the
licensed patent rights, up to $137,500 for the first product
covered by the licensed know-how and not the licensed patent
rights and an additional $50,000 for each additional
distinguishable product covered by the licensed know-how and not
the licensed patent rights, in each case upon the achievement of
specified development and regulatory milestones for the
applicable licensed product. In addition, Critical Therapeutics
agreed to pay The Feinstein Institute royalties based on net
sales of licensed products by Critical Therapeutics and its
affiliates until the later of ten years from the first
commercial sale of each licensed product in a given country and
the expiration of the patent rights covering the licensed
product in that country. Critical Therapeutics agreed to pay
minimum annual royalties to The Feinstein Institute beginning in
July 2007 regardless of whether Critical Therapeutics sells any
licensed products. Critical Therapeutics paid The Feinstein
Institute $15,000 for minimum royalties in 2007. Critical
Therapeutics also agreed to pay The Feinstein Institute fees if
Critical Therapeutics sublicenses its rights under the licensed
patent rights and know-how. At December 31, 2007, Critical
Therapeutics accrued $13,000 owed to The Feinstein Institute in
accordance with this agreement. Each party has the right to
terminate the agreement upon the occurrence of a material
uncured breach by the other party.
Critical Therapeutics also has entered into two sponsored
research and license agreements with The Feinstein Institute. In
July 2001, Critical Therapeutics entered into a sponsored
research and license agreement with The Feinstein Institute
under which, as amended, Critical Therapeutics paid The
Feinstein Institute $200,000 annually until June 2006 to sponsor
research activities at The Feinstein Institute to identify
inhibitors and antagonists of HMGB1 and related proteins,
including antibodies. In January 2003, Critical Therapeutics
entered into a sponsored research and license agreement with The
Feinstein Institute under which, as amended, Critical
Therapeutics agreed to pay The Feinstein Institute to sponsor
research activities at The Feinstein Institute in the field of
cholinergic anti-inflammatory technology. Critical Therapeutics
paid the Feinstein Institute $200,000 annually until January
2006 and $150,000 in 2006 and $120,000 in 2007 for this
sponsored research. Any future research terms under either of
these agreements are subject to agreement between The
179
Feinstein Institute and Critical Therapeutics. Under the terms
of these agreements, Critical Therapeutics acquired an exclusive
worldwide license to make, use and sell products covered by the
patent rights and
know-how
arising from the sponsored research. The Feinstein Institute
retained the right under each of these agreements to make and
use the licensed products in its own laboratories solely for
non-commercial, scientific purposes and non-commercial research.
Each party has the right to terminate each agreement upon the
occurrence of a material uncured breach of that agreement by the
other party.
In connection with the July 2001 sponsored research and license
agreement, Critical Therapeutics issued The Feinstein Institute
27,259 shares of Critical Therapeutics common stock
and agreed to make milestone payments to The Feinstein Institute
of $200,000 for the first product covered by the licensed patent
rights, and an additional $100,000 for each additional
distinguishable product covered by the licensed patent rights,
$100,000 for the first product covered by the licensed know-how
and not the licensed patent rights and an additional $50,000 for
each additional distinguishable product covered by the licensed
know-how and not the licensed patent rights, in each case upon
the achievement of specified development and regulatory approval
milestones with respect to the applicable licensed product. In
connection with the January 2003 sponsored research and license
agreement, Critical Therapeutics paid The Feinstein Institute an
initial license fee of $175,000 and agreed to pay additional
amounts in connection with the filing of any U.S. patent
application or issuance of a U.S. patent relating to the
field of cholinergic anti-inflammatory technology. Critical
Therapeutics also agreed to make aggregate milestone payments to
The Feinstein Institute of up to $1.5 million in both cash
and shares of Critical Therapeutics common stock upon the
achievement of specified development and regulatory approval
milestones with respect to any licensed product. In addition,
under each of these agreements, Critical Therapeutics agreed to
pay The Feinstein Institute royalties based on net sales of a
licensed product by Critical Therapeutics and its affiliates
until the later of ten years from the first commercial sale of
licensed products in a given country and the expiration of the
patent rights covering the licensed product in that country.
Under the January 2003 sponsored research and license agreement,
Critical Therapeutics agreed to pay minimum annual royalties to
The Feinstein Institute beginning in the first year after
termination of research activities regardless of whether
Critical Therapeutics sells any licensed products. At
December 31, 2007, Critical Therapeutics owed $30,000 to
The Feinstein Institute in accordance with the January 2003
agreement.
Critical Therapeutics also agreed to pay The Feinstein Institute
certain fees if Critical Therapeutics sublicenses its rights
under the licensed patent rights and know-how under either
agreement. In connection with Critical Therapeutics
sublicenses to MedImmune and Beckman Coulter of Critical
Therapeutics rights with respect to HMGB1, Critical
Therapeutics paid The Feinstein Institute $2.5 million and
issued to The Feinstein Institute 66,666 shares of Critical
Therapeutics common stock. In connection with Critical
Therapeutics January 2007 sublicense to SetPoint of
Critical Therapeutics rights with respect to vagus nerve
stimulation, Critical Therapeutics has paid The Feinstein
Institute $100,000 and arranged for the issuance by SetPoint to
The Feinstein Institute of 100,000 shares of junior
preferred stock of SetPoint.
Jagotec
AG
In December 2003, Critical Therapeutics entered into an
agreement with Jagotec under which Jagotec consented to
Abbotts sublicense to Critical Therapeutics of rights to
make, use and sell ZYFLO CR covered by Jagotecs patent
rights and know-how. Under the terms of the agreement, Jagotec
also agreed to manufacture ZYFLO CR for clinical trials,
regulatory review and, upon FDA approval and subject to
negotiating a manufacturing agreement, commercial sale. In
consideration for Jagotecs prior work associated with the
licensed patent rights and know-how, Critical Therapeutics paid
Jagotec an upfront fee of $750,000. Critical Therapeutics also
agreed to make aggregate milestone payments to Jagotec of up to
$6.6 million upon the achievement of various development
and commercialization milestones. Through December 31,
2007, Critical Therapeutics has made milestone payments totaling
$3.0 million to Jagotec under this agreement. In addition,
after the FDA approved the NDA for ZYFLO CR in May 2007,
Critical Therapeutics accrued an additional $699,000 in
milestone payments it owes to Jagotec on the first and second
anniversary of the approval of the NDA for ZYFLO CR. In
addition, Critical Therapeutics agreed to pay royalties to
Jagotec based upon net sales of the product by Critical
Therapeutics and its affiliates. Critical Therapeutics also
agreed
180
to pay royalties to Jagotec under the license agreement between
Jagotec and Abbott based upon net sales of the product by
Critical Therapeutics and its affiliates. In addition, Critical
Therapeutics agreed to pay Jagotec fees if Critical Therapeutics
sublicenses its rights under the licensed patent rights and
know-how. In 2005, Jagotec agreed to allow Critical Therapeutics
to sublicense its rights to Patheon to permit Patheon to
manufacture a portion of Critical Therapeutics annual
requirements for ZYFLO CR tablets. Each party has the right to
terminate the agreement upon the occurrence of a material
uncured breach by the other party.
SetPoint
In January 2007, Critical Therapeutics entered into an exclusive
license agreement with SetPoint under which Critical
Therapeutics granted to SetPoint an exclusive worldwide license
under patent rights and know-how controlled by Critical
Therapeutics relating to the stimulation of the vagus nerve to
make, use and sell products and methods covered by the licensed
patent rights and know-how in the licensed field. The licensed
field includes mechanical and electrical stimulation of the
vagus nerve and excludes pharmacological modulation of a
cholinergic receptor, including the alpha-7 receptor. In
consideration for the license, SetPoint paid Critical
Therapeutics an initial license fee of $400,000 in cash after
taking into account payments that Critical Therapeutics is
obligated to make to The Feinstein Institute. In addition, in
connection with SetPoints first financing, SetPoint issued
to Critical Therapeutics a number of shares of junior preferred
stock of SetPoint equal to the number of shares of preferred
stock that could be purchased for $400,000 in such financing
after taking into account payments that Critical Therapeutics is
obligated to make to The Feinstein Institute. The junior
preferred stock issued to Critical Therapeutics had a
liquidation preference subordinate to the preferred stock issued
in such financing. In March 2008, Critical Therapeutics sold
these 400,000 shares of junior preferred stock to two
investors, which had participated in SetPoints first
financing, for an aggregate purchase price of $400,000. The
purchase price is subject to adjustment if these investors sell
or receive consideration for these shares of junior preferred
stock pursuant to an acquisition of SetPoint prior to
February 1, 2009 at a price per share greater than they
paid Critical Therapeutics.
Under this license agreement, SetPoint also agreed to:
|
|
|
|
|
make a one-time milestone payment to Critical Therapeutics of
$1.0 million upon the achievement of all regulatory
approvals from the FDA or any foreign counterpart agency
required for the marketing and sale in the applicable country of
any product or method covered by the licensed patent rights;
|
|
|
|
pay Critical Therapeutics royalties based on net sales of
licensed products and methods by SetPoint and its affiliates
until the expiration of the patent rights covering the licensed
product or method in the country of actual or intended
use; and
|
|
|
|
pay Critical Therapeutics a percentage of any royalties, fees
and payments actually received from third parties, with limited
exceptions, in connection with sublicenses by SetPoint of its
rights under the licensed patent rights and know-how.
|
The patent rights and know-how licensed by Critical Therapeutics
to SetPoint include patent rights and know-how arising from
research conducted by The Feinstein Institute under the
sponsored research and license agreement, as amended, that
Critical Therapeutics entered into with The Feinstein Institute
in January 2003.
Under this license agreement, SetPoint agreed to be responsible
for specified obligations Critical Therapeutics owes to The
Feinstein Institute pursuant to Critical Therapeutics
sponsored research and license agreement. SetPoint agreed to
financially support sponsored research under the sponsored
research and license agreement to the extent that the sponsored
research is in the licensed field under the SetPoint license
agreement. SetPoint also agreed to reimburse Critical
Therapeutics for a portion of:
|
|
|
|
|
amounts payable to The Feinstein Institute in connection with
the filing of any U.S. patent application or issuance of a
U.S. patent relating to the field of cholinergic
anti-inflammatory technology; and
|
|
|
|
minimum annual royalties payable to The Feinstein Institute
beginning in the first year after termination of research
activities under the sponsored research agreement.
|
181
Each party has the right to terminate the license agreement upon
the occurrence of a material uncured default by the other party.
SetPoint has the right to terminate the SetPoint license
agreement at any time on
90-days
prior written notice to Critical Therapeutics.
Two of Critical Therapeutics co-founders, Kevin J.
Tracey, M.D. and H. Shaw Warren, M.D., are founders of
SetPoint. Dr. Warren served as a member of the Critical
Therapeutics Board of Directors until October 2006.
Dr. Tracey is a member of the medical staff at The
Feinstein Institute. In addition, Critical Therapeutics is a
party to a consulting agreement with Dr. Tracey that
terminates on December 31, 2009. Furthermore, Critical
Therapeutics was previously a party to a consulting agreement
with Dr. Warren that terminated on January 1, 2008.
Under Critical Therapeutics consulting agreement with
Dr. Tracey, Critical Therapeutics agreed to pay certain
royalties to Dr. Tracey in connection with selling or
sublicensing certain licensed alpha-7 products as defined in the
agreement.
Proprietary
Rights
Critical Therapeutics success depends in part on its
ability to obtain and maintain proprietary protection for its
product candidates, technology and know-how, to operate without
infringing on the proprietary rights of others and to prevent
others from infringing Critical Therapeutics proprietary
rights. Critical Therapeutics policy is to seek to protect
its proprietary position by, among other methods, filing
U.S. and foreign patent applications related to its
proprietary technology, inventions and improvements that are
important to the development of its business and obtaining,
where possible, assignment of invention agreements from
employees and consultants. Critical Therapeutics also relies on
trade secrets, know-how, continuing technological innovation and
in-licensing opportunities to develop and maintain its
proprietary position.
As of September 15, 2008, Critical Therapeutics owns or
exclusively licenses for one or more indications or formulations
a total of 16 issued U.S. patents, 50 issued foreign
patents, 22 pending U.S. patent applications and 60 pending
foreign patent applications consisting of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
|
Foreign
|
|
|
Program
|
|
|
|
Issued
|
|
|
Pending
|
|
|
Issued
|
|
|
Pending
|
|
|
Total
|
|
|
Zileuton
|
|
|
2
|
|
|
|
1
|
|
|
|
18
|
|
|
|
5
|
|
|
|
26
|
|
HMGB1
|
|
|
10
|
|
|
|
13
|
|
|
|
22
|
|
|
|
34
|
|
|
|
79
|
|
Alpha-7
|
|
|
4
|
|
|
|
8
|
|
|
|
10
|
|
|
|
21
|
|
|
|
43
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
16
|
|
|
|
22
|
|
|
|
50
|
|
|
|
60
|
|
|
|
148
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The U.S. patent covering the composition of matter of
zileuton that Critical Therapeutics licensed from Abbott expires
in December 2010. The patent for ZYFLO CR will expire in June
2012 and relates only to the controlled-release technology used
to control the release of zileuton. The U.S. issued patents
that Critical Therapeutics owns or exclusively licenses covering
Critical Therapeutics product candidates other than
zileuton expire on various dates between 2019 and 2021.
The patent position of pharmaceutical or biotechnology
companies, including Critical Therapeutics, is generally
uncertain and involves complex legal and factual considerations.
Critical Therapeutics success depends, in part, on its
ability to protect proprietary products, methods and
technologies that it develops under the patent and other
intellectual property laws of the United States and other
countries, so that Critical Therapeutics can prevent others from
using its inventions and proprietary information. If any parties
should successfully claim that Critical Therapeutics
proprietary products, methods and technologies infringe upon
their intellectual property rights, Critical Therapeutics might
be forced to pay damages, and a court could require it to stop
the infringing activity. Critical Therapeutics does not know if
its pending patent applications will result in issued patents.
Critical Therapeutics issued patents and those that may
issue in the future, or those licensed to Critical Therapeutics,
may be challenged, invalidated or circumvented, which could
limit Critical Therapeutics ability to stop competitors
from marketing related products or the length of term of patent
protection that it may have for its products. In addition, the
rights granted under any issued patents may not provide Critical
Therapeutics with proprietary protection or competitive
advantages against competitors with similar technology.
Furthermore, Critical Therapeutics competitors may
independently develop similar
182
technologies or duplicate any technology developed by it.
Because of the extensive time required for development, testing
and regulatory review of a potential product, it is possible
that, before any of Critical Therapeutics product
candidates can be commercialized, any related patent may expire
or remain in force for only a short period following
commercialization, thereby reducing any advantage of the patent.
Trademarks,
Trade Secrets and Other Proprietary Information
Critical Therapeutics has registered the Critical Therapeutics
name and logo in both the United States and the European
Community. Critical Therapeutics has registered ZYFLO CR and CT2
in the United States. Critical Therapeutics has also filed
trademark applications to register CRTX in the United States. In
March 2004, Critical Therapeutics acquired the
U.S. trademark for ZYFLO from Abbott.
In addition, Critical Therapeutics depends upon trade secrets,
know-how and continuing technological advances to develop and
maintain Critical Therapeutics competitive position. To
maintain the confidentiality of trade secrets and proprietary
information, it is Critical Therapeutics general practice
to enter into confidentiality agreements with its employees,
consultants, strategic partners, outside scientific
collaborators and sponsored researchers and other advisors.
These agreements are designed to protect Critical
Therapeutics proprietary information. These agreements are
designed to deter, but may not prevent, unauthorized disclosure
of Critical Therapeutics trade secrets, and any such
unauthorized disclosure would have a material adverse effect on
Critical Therapeutics business, for which monetary damages
from the party making such unauthorized disclosure may not be
adequate to compensate Critical Therapeutics.
Regulatory
Matters
The research, testing, manufacture and marketing of drug and
biologic products are extensively regulated in the United States
and abroad. In the United States, drugs and biologics are
subject to rigorous regulation by the FDA. The federal Food,
Drug, and Cosmetic Act and other federal and state statutes and
regulations govern, among other things, the research,
development, testing, manufacture, storage, recordkeeping,
packaging, labeling, advertising and promotion, sampling and
distribution of pharmaceutical and biologic products. The
failure to comply with the applicable regulatory requirements
may subject Critical Therapeutics to a variety of administrative
or judicially imposed sanctions, including the FDAs
refusal to file new applications or to approve pending
applications, withdrawal of an approval, warning letters,
product recalls, product seizures, total or partial suspension
of production or distribution, injunctions, fines, civil
penalties and criminal prosecution.
The steps ordinarily required before a new pharmaceutical or
biologic product may be marketed in the United States
include preclinical laboratory tests, animal tests and
formulation studies, the submission to the FDA of an IND, which
must become effective prior to commencement of human clinical
testing, and adequate and well-controlled clinical trials to
establish that the product is safe and effective for the
indication for which FDA approval is sought. Satisfaction of FDA
approval requirements typically takes several years and the
actual time taken may vary substantially depending upon the
complexity of the product, disease or clinical trials required.
Government regulation may impose costly procedures on Critical
Therapeutics activities, and may delay or prevent
marketing of potential products for a considerable period of
time or prevent such marketing entirely. Success in early stage
clinical trials does not necessarily assure success in later
stage clinical trials. Data obtained from clinical activities
are not always conclusive and may be subject to alternative
interpretations that could delay, limit or even prevent
regulatory approval. Even if a product receives regulatory
approval, later discovery of previously unknown problems with a
product may result in marketing or sales restrictions on the
product or even complete withdrawal of the product from the
market.
Preclinical tests include laboratory evaluation of product
chemistry, toxicity and formulation, as well as animal studies
to assess the potential safety and efficacy of the product. The
conduct of the preclinical tests and formulation of compounds
for testing must comply with federal regulations and
requirements. The results of preclinical testing are submitted
to the FDA as part of an IND during the IND stage of development
and as part of the NDA.
183
An IND must become effective prior to the commencement of
clinical testing of a drug or biologic in humans. An IND will
automatically become effective 30 days after receipt by the
FDA if the FDA has not commented on or questioned the
application during this
30-day
waiting period. If the FDA has comments or questions, these may
need to be resolved to the satisfaction of the FDA prior to
commencement of clinical trials. In addition, the FDA may, at
any time, impose a clinical hold on ongoing clinical trials. If
the FDA imposes a clinical hold, clinical trials cannot commence
or recommence without FDA authorization and then only under
terms authorized by the FDA. The IND process can result in
substantial delay and expense.
Clinical trials involve the administration of the
investigational new drug or biologic to healthy volunteers or
patients under the supervision of a qualified investigator.
Clinical trials must be conducted in compliance with federal
regulations and requirements, under protocols detailing the
objectives of the trial, the parameters to be used in monitoring
safety and the safety and effectiveness criteria to be
evaluated. Each protocol for an unapproved drug involving
testing human subjects in the United States must be submitted to
the FDA as part of the IND. The trial protocol and informed
consent information for subjects in clinical trials must be
submitted to institutional review boards for approval.
Clinical trials to support new drug or biologic product
applications for marketing approval are typically conducted in
three sequential phases, but the phases may overlap. In
Phase I, the initial introduction of the product candidate
into healthy human subjects or patients, the product is tested
to assess metabolism, pharmacokinetics, safety, including side
effects associated with increasing doses, and, at times,
pharmacological actions. Phase II usually involves trials
in a limited patient population, to determine dosage tolerance
and optimum dosage, identify possible adverse effects and safety
risks, and provide preliminary support for the efficacy of the
product in the indication being studied.
If a compound demonstrates evidence of effectiveness and an
acceptable safety profile in Phase II evaluations,
Phase III trials are undertaken to evaluate further
clinical efficacy and to test further for safety within an
expanded patient population, typically at geographically
dispersed clinical trial sites. Phase I, Phase II or
Phase III testing of any product candidates may not be
completed successfully within any specified time period, if at
all. Furthermore, the FDA, an institutional review board or
Critical Therapeutics may suspend or terminate clinical trials
at any time on various grounds, including a finding that the
subjects or patients are being exposed to an unacceptable health
risk.
After successful completion of the required clinical testing for
a drug, generally an NDA is prepared and submitted to the FDA.
FDA approval of the NDA is required before marketing of the
product may begin in the United States. The NDA must include the
results of all clinical and preclinical safety testing and a
compilation of the data relating to the products
pharmacology, chemistry, manufacture and controls. The cost of
preparing and submitting an NDA is substantial. Under federal
law, the submission of NDAs are additionally subject to
substantial application user fees, currently exceeding
$1,100,000, the fee for submission of supplemental applications
exceeds $580,000 and the manufacturer
and/or
sponsor under an approved NDA are also subject to annual product
and establishment user fees, currently exceeding $65,000 per
product and up to $392,000 per establishment. These fees are
typically increased annually.
The FDA has 60 days from its receipt of an NDA to determine
whether the application will be accepted for filing based on the
agencys threshold determination that the NDA is
sufficiently complete to permit substantive review. Once the
submission is accepted for filing, the FDA begins an in-depth
review of the NDA. The review process is often significantly
extended by FDA requests for additional information or
clarification regarding information already provided in the
submission. The FDA may also refer applications for novel drug
products or drug products which present difficult questions of
safety or efficacy to an advisory committee, typically a panel
that includes clinicians and other experts, for review,
evaluation and a recommendation as to whether the application
should be approved. The FDA is not bound by the recommendation
of an advisory committee. The FDA normally also will conduct a
pre-approval inspection to ensure the manufacturing facility,
methods and controls are adequate to preserve the drugs
identity, strength, quality, purity and stability, and are in
compliance with regulations governing current good manufacturing
practices. In addition, the FDA usually conducts audits of the
clinical trials for new drug applications and efficacy
supplements to ensure that the data submitted reflects the data
generated by the clinical sites.
184
If the FDAs evaluations of the NDA and the manufacturing
facilities are favorable, the FDA may issue an approval letter,
or, in some cases, a complete response letter followed by an
approval letter. A complete response letter generally contains a
statement that the application is not yet ready for approval and
describes specific deficiencies and, if applicable, recommended
actions an applicant might take to get the application ready for
approval. An approval letter authorizes commercial marketing of
the drug with specific prescribing information for specific
indications. As a condition of NDA approval, the FDA may require
post-approval trials and surveillance to monitor the drugs
safety or efficacy and may impose other conditions, including
labeling restrictions and restricted distribution, which can
materially impact the potential market and profitability of the
drug. Once granted, product approvals may be withdrawn if
compliance with regulatory standards is not maintained or
problems are identified following initial marketing.
Supplemental applications must be filed for many post-approval
changes, including changes in manufacturing facilities.
Some of Critical Therapeutics products may be regulated as
biologics under the Public Health Service Act. Biologics must
have a biologics license application, or BLA, approved prior to
commercialization. Like NDAs, BLAs are subject to user fees. To
obtain BLA approval, an applicant must provide preclinical and
clinical evidence and other information to demonstrate that the
biologic product is safe, pure and potent and that the
facilities in which it is manufactured processed, packed or held
meet standards, including good manufacturing practices and any
additional standards in the license designed to ensure its
continued safety, purity and potency. Biologics establishments
are subject to preapproval inspections. The review process for
BLAs is time consuming and uncertain, and BLA approval may be
conditioned on post-approval testing and surveillance. Once
granted, BLA approvals may be suspended or revoked under certain
circumstances, such as if the product fails to conform to the
standards established in the license.
Once the NDA or BLA is approved, a product will be subject to
certain post-approval requirements, including requirements for
adverse event reporting and submission of periodic reports. In
addition, the FDA strictly regulates the promotional claims that
may be made about prescription drug products and biologics. In
particular, the FDA requires substantiation of any claims of
superiority of one product over another, including that such
claims be proven by adequate and well-controlled head-to-head
clinical trials. To the extent that market acceptance of
Critical Therapeutics products may depend on their
superiority over existing therapies, any restriction on Critical
Therapeutics ability to advertise or otherwise promote
claims of superiority, or requirements to conduct additional
expensive clinical trials to provide proof of such claims, could
negatively affect the sales of Critical Therapeutics
products or Critical Therapeutics costs.
Critical Therapeutics must also notify the FDA of any change in
an approved product beyond variations already allowed in the
approval. Certain changes to the product, its labeling or its
manufacturing require prior FDA approval, including conduct of
further clinical investigations to support the change. Major
changes in manufacturing site require submission of an sNDA and
approval by the FDA prior to distribution of the product using
the change. Such supplements, referred to as Prior Approval
Supplements, must contain information validating the effects of
the change. An applicant may ask the FDA to expedite its review
of such a supplement for public health reasons, such as a drug
shortage. Approvals of labeling or manufacturing changes may be
expensive and time-consuming and, if not approved, the product
will not be allowed to be marketed as modified.
If the FDAs evaluation of the NDA submission or
manufacturing facilities is not favorable, the FDA may refuse to
approve the NDA and issue a complete response letter. The
complete response letter outlines the deficiencies in the
submission and often requires additional testing or information
in order for the FDA to reconsider the application. Even after
submitting this additional information, the FDA ultimately may
decide that the application does not satisfy the regulatory
criteria for approval. With limited exceptions, the FDA may
withhold approval of an NDA regardless of prior advice it may
have provided or commitments it may have made to the sponsor.
Once an NDA is approved, the product covered thereby becomes a
listed drug that can, in turn, be cited by potential
competitors in support of approval of an ANDA. An ANDA provides
for marketing of a drug product that has the same active
pharmaceutical ingredients in the same strengths and dosage form
as the listed drug and has been shown through bioequivalence
testing to be therapeutically equivalent to the listed drug.
There is
185
no requirement, other than the requirement for bioequivalence
testing, for an ANDA applicant to conduct or submit results of
preclinical or clinical tests to prove the safety or efficacy of
its drug product. Drugs approved in this way are commonly
referred to as generic equivalents to the listed
drug, are listed as such by the FDA, and can often be
substituted by pharmacists under prescriptions written for the
original listed drug.
Federal law provides for a period of three years of exclusivity
following approval of a listed drug that contains previously
approved active pharmaceutical ingredients but is approved in a
new dosage, dosage form, route of administration or combination,
or for a new use, the approval of which was required to be
supported by new clinical trials conducted by or for the
sponsor. During such three-year exclusivity period, the FDA
cannot grant effective approval of an ANDA to commercially
distribute a generic version of the drug based on that listed
drug. However, the FDA can approve generic equivalents of that
listed drug based on other listed drugs, such as a generic that
is the same in every way but its indication for use, and thus
the value of such exclusivity may be undermined. Federal law
also provides a period of five years following approval of a
drug containing no previously approved active pharmaceutical
ingredients. During such five-year exclusivity period, ANDAs for
generic versions of those drugs cannot be submitted unless the
submission accompanies a challenge to a listed patent, in which
case the submission may be made four years following the
original product approval. Additionally, in the event that the
sponsor of the listed drug has properly informed the FDA of
patents covering its listed drug, applicants submitting an ANDA
referencing that drug are required to make one of four
certifications, including certifying that it believes one or
more listed patents are invalid or not infringed. If an
applicant certifies invalidity or non-infringement, it is
required to provide notice of its filing to the NDA sponsor and
the patent holder. If the patent holder then initiates a suit
for patent infringement against the ANDA sponsor within
45 days of receipt of the notice, the FDA cannot grant
effective approval of the ANDA until either 30 months has
passed or there has been a court decision holding that the
patents in question are invalid or not infringed. If the NDA
holder and patent owners do not begin an infringement action
within 45 days, the ANDA applicant may bring a declaratory
judgment action to determine patent issues prior to marketing.
If the ANDA applicant certifies that it does not intend to
market its generic product before some or all listed patents on
the listed drug expire, then FDA cannot grant effective approval
of the ANDA until those patents expire. If more than one
applicant files a substantially complete ANDA on the same day
for a previously unchallenged drug, each such first
applicant will be entitled to share the
180-day
exclusivity period, but there will only be one such period,
beginning on the date of first marketing by any of the first
applicants. The first ANDA submitting substantially complete
applications certifying that listed patents for a particular
product are invalid or not infringed may qualify for a period of
180 days after the first marketing of the generic product,
during which subsequently submitted ANDAs cannot be granted
effective approval.
Violation of any FDA requirements could result in enforcement
actions, such as withdrawal of approval, product recalls,
product seizures, injunctions, total or partial suspension of
production or distribution, fines, consent decrees, civil
penalties and criminal prosecutions, which could have a material
adverse effect on Critical Therapeutics business.
From time to time, legislation is drafted and introduced in
Congress that could significantly change the statutory
provisions governing the development, approval, manufacturing
and marketing of drug products. In addition, FDA regulations and
guidance are often revised or reinterpreted by the agency in
ways that may significantly affect Critical Therapeutics
business and its products. It is impossible to predict whether
legislative changes will be enacted, or FDA regulations,
guidance or interpretations changed, or what the impact of such
changes, if any, may be.
Foreign
Regulation
Approval of a product by comparable regulatory authorities may
be necessary in foreign countries prior to the commencement of
marketing of the product in those countries, whether or not FDA
approval has been obtained. The approval procedure varies among
countries and can involve requirements for additional testing.
The time required may differ from that required for FDA
approval. Although there are some procedures for unified filings
for some European countries, such as the sponsorship of the
country which first granted marketing approval, in general each
country has its own procedures and requirements, many of which
are time
186
consuming and expensive. Thus, there can be substantial delays
in obtaining required approvals from foreign regulatory
authorities after the relevant applications are filed.
Under European Union regulatory systems, marketing authorization
applications may be submitted at a centralized, a decentralized
or a national level. The centralized procedure is mandatory for
the approval of biotechnology products and provides for the
grant of a single marketing authorization that is valid in all
European Union member states. As of January 1995, a mutual
recognition procedure is available at the request of the
applicant for all medicinal products that are not subject to the
centralized procedure. Critical Therapeutics will choose the
appropriate route of European regulatory filing to accomplish
the most rapid regulatory approvals. However, Critical
Therapeutics chosen regulatory strategy may not secure
regulatory approvals on a timely basis or at all.
Hazardous
Materials
Critical Therapeutics previous research and development
processes involved the controlled use of hazardous materials,
chemicals and radioactive materials and produce waste products.
Critical Therapeutics is subject to federal, state and local
laws and regulations governing the use, manufacture, storage,
handling and disposal of hazardous materials and waste products.
Critical Therapeutics does not expect the cost of complying with
these laws and regulations to be material.
Competition
The pharmaceutical and biotechnology industries in which
Critical Therapeutics operate are characterized by rapidly
advancing technologies and intense competition. Critical
Therapeutics competitors include pharmaceutical companies,
biotechnology companies, specialty pharmaceutical and generic
drug companies, academic institutions, government agencies and
research institutions. All of these competitors currently engage
in or may engage in the future in the development, manufacture
and commercialization of new pharmaceuticals, some of which may
compete with Critical Therapeutics present or future
products and product candidates. Many of Critical
Therapeutics competitors have greater development,
financial, manufacturing, marketing and sales experience and
resources than Critical Therapeutics does, and they may develop
new products or technologies that will render Critical
Therapeutics products or technologies obsolete or
noncompetitive. Critical Therapeutics cannot assure you that
Critical Therapeutics products will compete successfully
with these newly emerging technologies. In some cases,
competitors will have greater name recognition and may offer
discounts as a competitive tactic.
A number of large pharmaceutical and biotechnology companies
currently market and sell products to treat asthma that compete
with ZYFLO CR. Many established therapies currently command
large market shares in the asthma market, including
Merck & Co., Inc.s
Singulair®,
GlaxoSmithKline plcs
Advair®
and inhaled corticosteroid products. In addition, Critical
Therapeutics may face competition from pharmaceutical companies
seeking to develop new drugs for the asthma market. For example,
in June 2007, AstraZeneca commercially launched in the United
States
Symbicort®,
a twice-daily asthma therapy combining budesonide, an inhaled
corticosteroid, and formoterol, a long-acting beta2-agonist.
In the COPD market, zileuton, if Critical Therapeutics is able
to develop it as a treatment for COPD, will face intense
competition. COPD patients are currently treated primarily with
a number of medications that are indicated for COPD, asthma or
both COPD and asthma. The primary products used to treat COPD
are anticholinergics, long-acting beta-agonists and combination
long-acting beta-agonists and inhaled corticosteroids. These
medications are delivered in various device formulations,
including metered dose inhalers, dry powder inhalers and by
nebulization. Lung reduction surgery is also an option for COPD
patients.
Many therapies for COPD are already well established in the
respiratory marketplace, including GlaxoSmithKlines
Advair®
and
Serevent®
and
Spiriva®,
a once-daily muscarinic antagonist from Boehringer Ingleheim
GmbH and Pfizer. Other novel approaches are also in development.
Critical Therapeutics is also developing zileuton injection for
use in the hospital emergency department for the treatment of
acute asthma attacks. Critical Therapeutics may face intense
competition from companies seeking
187
to develop new drugs for use in severe acute asthma attacks. For
example, Merck & Co., Inc. is conducting clinical
trials of an intravenous formulation of its product
Singulair®.
If Critical Therapeutics therapeutic programs directed
toward the bodys inflammatory response result in
commercial products, such products will compete predominantly
with therapies that have been approved for diseases such as
rheumatoid arthritis, like Amgen, Inc.s
Enbrel®,
Johnson & Johnsons
Remicade®,
Bristol-Myers Squibb Companys
Orencia®,
Abbott Laboratories
Humira®
and
Rituxan®
marketed by Biogen Idec Inc. and Genentech, Inc., and diseases
such as sepsis, like Eli Lilly and Companys
Xigris®.
While non-steroidal, anti-inflammatory drugs like ibuprofen are
often used for the treatment of rheumatoid arthritis and offer
efficacy in reducing pain and inflammation, Critical
Therapeutics believes that Critical Therapeutics
cytokine-based therapeutic programs will compete predominantly
with the anti-TNF alpha therapies that have been approved for
diseases such as rheumatoid arthritis, like
Enbrel®
and
Remicade®.
Xigris®,
a product developed by Eli Lilly for sepsis, has received
regulatory approval for severe sepsis patients. Other than a
wide range of anti-infective drugs, Xigris is one of the only
drugs approved by the FDA for the treatment of sepsis. Other
companies are developing therapies directed towards cytokines.
Critical Therapeutics does not know whether any or all of these
products under development will ever reach the market and if
they do, whether they will do so before or after Critical
Therapeutics products are approved.
Critical Therapeutics competitors products may be
safer, more effective, more convenient or more effectively
marketed and sold, than any of Critical Therapeutics
products. Many of Critical Therapeutics competitors have:
|
|
|
|
|
significantly greater financial, technical and human resources
than Critical Therapeutics has and may be better equipped to
discover, develop, manufacture and commercialize products;
|
|
|
|
more extensive experience than Critical Therapeutics has in
conducting preclinical studies and clinical trials, obtaining
regulatory approvals and manufacturing and marketing
pharmaceutical products;
|
|
|
|
competing products that have already received regulatory
approval or are in late-stage development; and
|
|
|
|
collaborative arrangements in Critical Therapeutics target
markets with leading companies and research institutions.
|
Critical Therapeutics will face competition based on the safety
and effectiveness of its products, the timing and scope of
regulatory approvals, the availability and cost of supply,
marketing and sales capabilities, reimbursement coverage, price,
patent position and other factors. Critical Therapeutics
competitors may develop or commercialize more effective, safer
or more affordable products, or obtain more effective patent
protection, than Critical Therapeutics is able to. Accordingly,
Critical Therapeutics competitors may commercialize
products more rapidly or effectively than Critical Therapeutics
is able to, which would adversely affect Critical
Therapeutics competitive position, the likelihood that its
product candidates will achieve initial market acceptance and
its ability to generate meaningful revenues from its product
candidates. Even if Critical Therapeutics product
candidates achieve initial market acceptance, competitive
products may render its products obsolete or noncompetitive. If
Critical Therapeutics product candidates are rendered
obsolete, it may not be able to recover the expenses of
developing and commercializing those product candidates.
Properties
Critical Therapeutics subleases approximately 11,298 square
feet of office space in Lexington, Massachusetts. The sublease
expires on February 28, 2009, and Critical Therapeutics has
an option to extend the term of the sublease for an additional
six months by providing written notice on or prior to October
31, 2008. Critical Therapeutics believes its facilities are
sufficient to meet its needs for the foreseeable future.
188
Employees
As of September 15, 2008, Critical Therapeutics had
42 full-time employees, 29 of whom were engaged in
marketing and sales, two of whom were engaged in development and
regulatory affairs, and 11 of whom were engaged in management,
administration and finance. None of Critical Therapeutics
employees are represented by a labor union or covered by a
collective bargaining agreement. Critical Therapeutics has not
experienced any work stoppages. Critical Therapeutics believes
that relations with its employees are good.
Legal
Proceedings
On September 17, 2008, a purported shareholder class action
lawsuit was filed by a single plaintiff against Critical
Therapeutics and each of its directors in the Court of Chancery
of The State of Delaware. The action is captioned Jeffrey
Benison IRA v. Critical Therapeutics, Inc., Trevor
Phillips, Richard W. Dugan, Christopher Mirabelli, and Jean
George (Case No. 4039, Court of Chancery, State of
Delaware). The plaintiff, which claims to be a stockholder of
Critical Therapeutics, brought the lawsuit on its own behalf,
and is seeking certification of the lawsuit as a class action on
behalf of all stockholders of Critical Therapeutics, except the
defendants and their affiliates. The complaint alleges, among
other things, that the defendants breached fiduciary duties of
loyalty and good faith, including a fiduciary duty of candor, by
failing to provide Critical Therapeutics stockholders with
a proxy statement/prospectus adequate to enable them to cast an
informed vote on the proposed merger, and by possibly failing to
maximize stockholder value by entering into an agreement that
effectively discourages competing offers. The complaint seeks,
among other things, an order (i) enjoining the defendants
from proceeding with or implementing the proposed merger on the
terms and under the circumstances as they presently exist,
(ii) invalidating the provisions of the proposed merger
that purportedly improperly limit the effective exercise of the
defendants continuing fiduciary duties,
(iii) ordering defendants to explore alternatives and to
negotiate in good faith with all bona fide interested
parties, (iv) in the event the proposed merger is
consummated, rescinding it and setting it aside or awarding
rescissory damages, (v) awarding compensatory damages
against defendants, jointly and severally, and
(vi) awarding the plaintiff and the purported class their
costs and fees.
Critical Therapeutics intends to defend against this lawsuit
vigorously.
Access to
SEC Filings
Critical Therapeutics files reports, proxy statements and other
information with the SEC as required by the Exchange Act. You
can find, copy and inspect information Critical Therapeutics
files at the SECs public reference room at
100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You can call the SEC at
1-800-SEC-0330
for further information about the public reference room. You can
review Critical Therapeutics electronically filed reports,
proxy and information statements on the SECs web site at
http:// www.sec.gov
or on Critical Therapeutics web site at
http://www.crtx.com.
189
CORNERSTONES
BUSINESS
Overview
Cornerstone is a specialty pharmaceutical company focused on
acquiring, developing and commercializing prescription products
for the respiratory market. Cornerstone currently promotes four
marketed products in the United States to respiratory-focused
physicians and key retail pharmacies with its approximately
50 person specialty sales force. Cornerstones
commercial strategy is to acquire non-promoted or
underperforming branded pharmaceutical products and then
maximize their potential value by promoting the products using
its sales and marketing capabilities and applying various
product life cycle management techniques. Cornerstones
product development pipeline consists of three line extensions
of one of its currently marketed products and a portfolio of
additional product candidates based on marketed drug compounds.
Cornerstone also generates revenue from the sale of seven
marketed product lines that include products that it does not
promote. Two of these seven product lines include products that
are promoted by third parties, and six of these product lines
include products that are not promoted by Cornerstone or any
third party. Four of these six product lines include generic
products that Cornerstone markets through Aristos
Pharmaceuticals, Inc., or Aristos, one of its wholly owned
subsidiaries. Cornerstone recognized net revenues of $23.5
million in the six months ended June 30, 2008, $28.1
million in 2007, $22.1 million in 2006 and $17.5 million in 2005.
Cornerstone actively promotes the following four respiratory
products because it believes they are most responsive to
promotional efforts: SPECTRACEF and three ALLERX Dose Pack
products. SPECTRACEF is an oral antibiotic indicated for the
treatment of mild to moderate infections caused by pathogens
associated with particular respiratory tract infections.
Cornerstones three ALLERX Dose Pack products are oral
tablets indicated for the temporary relief of symptoms
associated with allergic rhinitis. These four promoted products
generated aggregate net sales of $14.3 million in the six
months ended June 30, 2008 and $20.4 million in 2007.
The products that Cornerstone does not promote generated
additional aggregate net revenues of $9.2 million in the
six months ended June 30, 2008 and $7.0 million in
2007.
As of September 15, 2008, Cornerstones only products
that are subject to approved NDAs or ANDAs are SPECTRACEF,
BALACET 325, APAP 325 and APAP 500. Cornerstone markets its
remaining products without an FDA-approved marketing application
because Cornerstone considers them to be identical, related or
similar to products that have existed in the market without an
FDA-approved marketing application, and which were thought not
to require pre-market review and approval, or which were
approved only on the basis of safety, at the time they entered
the marketplace, subject to FDA enforcement policies established
in connection with the FDAs DESI program. For a more
complete discussion regarding FDA drug approval requirements,
please see the section entitled Risks Related to
Cornerstone Some of Cornerstones specialty
pharmaceutical products are now being marketed without approved
NDAs or ANDAs beginning on page 70 of this proxy
statement/prospectus and the section entitled
Cornerstones Business Regulatory
Matters beginning on page 222 of this proxy
statement/prospectus.
Cornerstones product development pipeline includes the
following three SPECTRACEF line extensions: a 400 mg dose
tablet, a once daily dosage tablet and an oral suspension for
the pediatric market. Cornerstones product development
pipeline also includes the following three additional product
candidates: a methscopolamine and antihistamine combination
product candidate for the treatment of symptoms of allergic
rhinitis and two extended-release antitussive, or cough
suppressant, combination product candidates. Cornerstone
believes that it can substantially mitigate the risks and
uncertainties and reduce the time and costs typically associated
with new drug development by utilizing Section 505(b)(2) of
the FDCA, or by filing sNDAs or ANDAs with the FDA for approval
of most of its product candidates. These development pathways
provide the potential for expedited development of new
formulations of existing compounds because they allow
Cornerstone to rely in part on the findings of safety and
efficacy of products already approved by the FDA in support of
Cornerstones applications for approval of new or improved
formulations. In situations in which it deems appropriate,
Cornerstone may choose to develop new formulations of existing
compounds that require Cornerstone to conduct new clinical
trials to obtain FDA marketing approval. If clinical trials are
required in connection with approval of a product candidate, the
new formulation may qualify for a three-year period of marketing
exclusivity in the United States under the Hatch-Waxman Act.
Cornerstone received
190
approval of its sNDA for its SPECTRACEF 400 mg line
extension in July 2008 and expects to submit applications for
approval to the FDA for each of its other current product
candidates by the end of 2010.
Strategy
Cornerstones goal is to become a leading specialty
pharmaceutical company that acquires, develops and
commercializes significant products for the respiratory market.
Key elements of Cornerstones strategy to achieve this goal
include the following:
Grow
Product Revenue through a Specialty Sales Force Focused on the
Respiratory Market.
Cornerstone intends to increase revenue from product sales by
using its commercial resources, including its specialty sales
force, to target respiratory specialists and primary care
physicians who are high-prescribers of respiratory products. By
concentrating its resources on the respiratory market,
Cornerstone believes that it can increase its profile among
prescribers, maximize the sales of its current products and
enhance its ability to acquire additional products and product
candidates. Cornerstone expects that revenue from sales of its
products will be a significant source of funds for product
acquisition, development and commercialization.
Acquire
Rights to Under-Promoted, Patent-Protected, Branded Respiratory
Pharmaceutical Products.
Cornerstone continues to seek to expand its product portfolio
through the acquisition of rights to FDA-approved respiratory
pharmaceutical products with well-established safety and
efficacy profiles and projected annual sales potential that
large pharmaceutical companies may view as insufficient to
justify the time required and the investment necessary to
promote with a large sales force. Cornerstone believes that its
experience and relationships in the specialty pharmaceutical
industry will allow it to identify and acquire products that are
under-promoted and would benefit from a focused sales and
marketing effort using Cornerstones commercial resources.
Since inception, Cornerstone has acquired or licensed rights to
the SPECTRACEF, ALLERX, HYOMAX, DECONSAL,
propoxyphene/acetaminophen, Extendryl and Humibid product lines
through its business development network and capabilities. As of
September 15, 2008, Cornerstone generated revenues from
each of these product lines, other than the Humibid product
line, the rights to which it transferred to Adams in February
2005.
Implement
Life Cycle Management Strategies.
Cornerstone expects to continue its efforts to implement life
cycle management strategies to maximize the potential value of
its currently marketed products, newly acquired products and
product candidates that are currently in development. These
strategies involve securing FDA approval for additional
indications for existing products, developing line extensions in
the form of new dosages and formulations of products that offer
improvements in patient convenience, compliance or safety and
introducing generic formulations of certain of
Cornerstones products through its Aristos subsidiary. In
the case of SPECTRACEF, for example, Cornerstone received
approval from the FDA in July 2008 for an sNDA for a 400 mg
tablet for twice daily dosing of SPECTRACEF that Cornerstone
believes would improve patient convenience as compared to the
current dosing of two 200 mg tablets twice daily. A key
aspect of this strategy involves the use of proprietary drug
delivery and formulation technologies, such that, if approved,
the new products may have patent protection or market
exclusivity while being commercialized.
Pursue
Strategic Relationships on a Selective Basis for Product
Development or Commercialization.
Cornerstone has entered into and may seek to enter into
additional strategic relationships with third parties in order
to facilitate the development and commercialization of its
products and product candidates. In particular, Cornerstone
expects to enter into arrangements that provide it with access
to drug delivery and formulation technologies if Cornerstone
determines that it is cost effective to do so given the
anticipated return on its investment. In addition, Cornerstone
has entered into and may seek to enter into additional
co-promotion arrangements to enhance its promotional efforts
and, therefore, sales of its products. By entering into
agreements with pharmaceutical companies that have experienced
sales forces with strong management
191
support, Cornerstone can reach health care providers in areas
where it has limited or no sales force representation.
Marketed
Products
Cornerstone currently actively promotes four of its marketed
products. The following table sets forth additional information
regarding Cornerstones currently marketed products that it
actively promotes.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
|
|
|
|
|
|
|
Ended
|
|
|
Promoted
|
|
Cornerstone
|
|
Active Pharmaceutical
|
|
|
|
June 30, 2008
|
|
2007
|
Product
|
|
Launch Date
|
|
Ingredient(s)
|
|
Primary Indication
|
|
Net Sales
|
|
Net Sales
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
SPECTRACEF
|
|
November 2006
|
|
Cefditoren
|
|
Treatment of mild to moderate infections that are caused by
susceptible strains of microorganisms in community-acquired
pneumonia, acute bacterial exacerbation of chronic bronchitis,
pharyngitis and tonsillitis and uncomplicated skin and
skin-structure infections
|
|
$1,795
|
|
$6,886
|
ALLERX Dose Pack
|
|
February 2005(1)
|
|
AM dose:
Pseudoephedrine and methscopolamine
|
|
Temporary relief of symptoms associated with allergic rhinitis
|
|
6,015
|
|
11,103
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PM dose:
Phenylephrine, chlorpheniramine and methscopolamine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALLERX Dose Pack DF (decongestant-free)
|
|
August 2006
|
|
AM dose:
Chlorpheniramine and methscopolamine
|
|
Temporary relief of symptoms associated with allergic rhinitis
|
|
2,554
|
|
967
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PM dose:
Chlorpheniramine and methscopolamine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALLERX Dose Pack PE
|
|
September 2006
|
|
AM dose:
Phenylephrine and methscopolamine
|
|
Temporary relief of symptoms associated with allergic rhinitis
|
|
3,935
|
|
1,439
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PM dose:
Phenylephrine, chlorpheniramine and methscopolamine
|
|
|
|
|
|
|
(1) ALLERX Dose Pack was reformulated in February 2008 as ALLERX
10 Dose Pack/ALLERX 30 Dose Pack.
Cornerstones marketed products that it does not promote
generated additional aggregate net revenues of $9.2 million
in the six months ended June 30, 2008 and $7.0 million
in 2007.
SPECTRACEF
Overview
SPECTRACEF, an antibiotic administered orally in tablet form, is
a third generation cephalosporin with the API cefditoren
pivoxil, a semi-synthetic cephalosporin. SPECTRACEF is indicated
for the treatment of mild to
192
moderate infections in adults and adolescents 12 years of
age or older that are caused by pathogens associated with
particular respiratory tract infections, including
community-acquired pneumonia, acute bacterial exacerbation of
chronic bronchitis, pharyngitis and tonsillitis and
uncomplicated skin and skin-structure infections.
Cornerstones net sales of SPECTRACEF were
$6.9 million in 2007 and $1.8 million in the six
months ended June 30, 2008.
Market
Opportunity and Other Treatment Options
According to a 2006 Datamonitor report, each year an average of
approximately 88 million patients in the United States are
diagnosed with respiratory tract infections, including
approximately 25 million with acute exacerbations of
chronic bronchitis, 22 million with acute bacterial
sinusitis and 19 million with community-acquired pneumonia.
According to this Datamonitor report, physicians typically
select respiratory tract infection treatments empirically
without prior identification of the specific pathogen causing
the infection, although antibiotic therapy is the most common
form of treatment regardless of whether the bacterial pathogen
can be identified. If the specific pathogen has not been
identified, health care providers sometimes choose which class
of antibiotic to prescribe based on the most likely pathogen
causing the infection based on the patients symptoms.
The U.S. oral antibiotic market is fairly fragmented, with
approximately 40 branded products and more than 50 generic
products. Pharmacists typically fill prescriptions for
antibiotics with generic products when available. According to
Wolters Kluwer Health, a third-party provider of prescription
data, in 2007, the U.S. oral solid antibiotic market
generated approximately 220 million prescriptions,
including approximately 44 million for macrolides, such as
generic formulations of Pfizer Inc.s
Zithromax®
(azithromycin) and Abbott Laboratories, Inc.s
Biaxin®
(clarithromycin), approximately 38 million for quinolones,
such as Ortho-McNeil-Janssen Pharmaceuticals, Inc.s
Levaquin®
(levofloxacin) and generic formulations of Bayer AGs
Cipro®
(ciprofloxacin), and approximately 8 million for second and
third generation cephalosporins, such as SPECTRACEF and Shionogi
USA, Inc.s
Cedax®
(ceftibuten) and generic formulations of Abbott Laboratories,
Inc.s
Omnicef®
(cefdinir), Pharmacia and Upjohn Company, Inc.s
Vantin®
(cefpodoxime), GlaxoSmithKline plcs
Ceftin®
(cefuroxime), Bristol-Myers Squibb Companys
Cefzil®
(cefprozil) and Eli Lilly & Companys
Ceclor®
(cefaclor). The only branded oral solid cephalosporin products
currently without generic competition in the United States are
SPECTRACEF, Cedax and Lupin Pharmaceuticals
Suprax®
(cefixime), which was recently re-introduced.
Macrolides generally are broad spectrum, have a low incidence of
side effects and have convenient dosing regimens. However,
macrolides can be associated with severe allergic reactions and
interactions with many other commonly prescribed drugs that can
affect potency. In addition, Streptococcus pneumoniae, a
bacterium causing lung infections, displays a high incidence of
resistance to macrolide antibiotics. Quinolones generally are
considered safe and efficacious overall and have convenient
dosing regimens. Quinolones, however, have multiple interactions
with commonly prescribed drugs, cannot be used in children and
have been associated with tendon rupture and photosensitivity
adverse reactions. Cephalosporins, including SPECTRACEF,
generally cause few side effects. Common side effects are
gastrointestinal in nature and are mild and transient.
Cephalosporins are classified in the United States based on
their spectrum of activity against different types of bacteria.
Bacteria are broadly classified into two categories based on the
composition of their cell wall structure: gram-positive or
gram-negative. In general, cephalosporins developed more
recently as follow-on products to the first generation of
cephalosporins approved for marketing, commonly referred to as
second and third generation cephalosporins, have greater
activity against gram-negative bacteria than earlier
generations, but decreasing activity against gram-positive
bacteria. First generation cephalosporins have good activity
against gram-positive bacteria, including Staphylococcus
aureus, a bacterium associated with skin infections, and
Streptococcus pyogenes, a bacterium associated with
pharyngitis and tonsillitis. Second generation cephalosporins
have greater activity against gram-negative bacteria, such as
Haemophilus influenzae, but also retain some activity
against gram-positive bacteria, including Staphylococcus
aureus and Streptococcus pyogenes. Second generation
cephalosporins also have some activity against bacteria, such as
Haemophilus influenzae and Moraxella catarrhalis,
that produce ß-lactamase, an enzyme that is able to
destroy some antibiotics before they can exert their effects on
the bacteria. Third generation cephalosporins have even
193
greater activity against a broad spectrum of
gram-negative
bacteria, such as Haemophilus influenzae and Moraxella
catarrhalis, including strains of bacteria that produce
ß-lactamase, but often have decreased activity against
gram-positive bacteria.
Cornerstone believes that SPECTRACEF currently is the only
branded second or third generation oral solid cephalosporin
product being actively promoted to health care providers in the
adult respiratory market, although Suprax is being promoted
within the pediatric market by Lupin Pharmaceuticals
specialty sales force, and Suprax is being promoted by Ascend
Therapeutics, Inc.s specialty sales force to obstetricians
and gynecologists pursuant to a co-promotion agreement with
Lupin Pharmaceuticals.
Benefits
of SPECTRACEF
SPECTRACEF is effective against several common respiratory
pathogens, including the three most prevalent pathogens in
respiratory tract infections as reported in the 2006 Datamonitor
report, Streptococcus pneumoniae, Haemophilus
influenzae and Moraxella catarrhalis. In two
previously conducted and published clinical trials, cefditoren,
present in SPECTRACEF as cefditoren pivoxil, demonstrated
superior potency as compared to cefdinir, cefuroxime and
cefprozil against community-acquired Streptococcus
pneumoniae, Haemophilus influenzae and Moraxella
catarrhalis.
Proprietary
Rights
Cornerstone has an exclusive license from Meiji to market
SPECTRACEF and related product candidates in the United States
under both an issued U.S. patent with claims to the
composition of matter of the API in SPECTRACEF, cefditoren
pivoxil, and an issued U.S. patent with claims to the
formulation of products like SPECTRACEF that contain a mixture
of cefditoren pivoxil with a water soluble casein salt. The
composition of matter patent expires in April 2009 and the
formulation patent expires in 2016. Cornerstone has also
licensed from Meiji the U.S. trademark rights to SPECTRACEF.
ALLERX
Overview
Cornerstones ALLERX Dose Pack products are oral tablets
indicated for the temporary relief of symptoms associated with
allergic rhinitis. Each ALLERX Dose Pack product contains the
antihistamine chlorpheniramine, a choice of decongestant,
including an option without a decongestant, and methscopolamine,
an anticholinergic, or drying agent, which provides additional
symptomatic relief by drying up the mucosal secretions
associated with allergic rhinitis. Cornerstones net sales
of ALLERX Dose Pack products were $13.5 million in 2007 and
$6.0 million in the six months ended June 30, 2008.
Market
Opportunity and Other Treatment Options
The American Academy of Allergy, Asthma & Immunology,
or AAAAI, defines rhinitis as an inflammation of the mucous
membranes of the nose with symptoms of sneezing, itching, nasal
discharge and congestion. Rhinitis can be allergic, nonallergic
or both. Seasonal allergic rhinitis is caused by substances that
trigger allergies, called allergens, and is sometimes referred
to as hay fever.
According to the Centers for Disease Control and Prevention, or
CDC, allergic rhinitis is believed to be responsible for
approximately 14.1 million physician visits annually.
According to a January 2006 Allergies in America survey,
approximately 69% of patients with allergic rhinitis had taken
medication for their nasal allergies in the prior four weeks,
including 45% who took prescription medication. The survey also
reported that 40% of patients surveyed indicated that nasal
allergies had a lot or a moderate amount of impact on their
daily life, compared with only 33% of patients who indicated
that nasal allergies had little or no impact on their daily life.
According to the Allergies in America survey, allergies
contribute to an average productivity loss of 25% among workers
who suffer from allergies on days when their allergies are at
their worst, and allergies resulted in missed workdays for 30%
of sufferers in the past year.
194
The cough, cold and allergy market is very fragmented with
hundreds of brands and even more generics. This market includes
prescription and over-the-counter antihistamine and
antihistamine combination products. First generation
antihistamines are widely available and have been used for more
than 50 years. They are associated with the side effect of
sedation, which can interfere with the patients quality of
life. Some first generation antihistamines, such as
chlorpheniramine, also exhibit some anticholinergic effects.
Second generation antihistamines were introduced because they
are less sedating than first generation antihistamines, but some
second generation antihistamines have been linked to cardiac
risks. Third generation antihistamines, which are metabolites of
second generation antihistamines, are less sedating than first
generation antihistamines and have not been associated with
cardiac risks. Unlike first generation antihistamines, neither
second generation nor third generation antihistamines exhibit
anticholinergic effects. In the January 2006 Allergies in
America survey, 62% of allergy sufferers reported a runny nose
and 61% of allergy sufferers reported post-nasal drip as usually
extremely or moderately bothersome during allergy attacks.
First generation prescription antihistamine and antihistamine
combination products include Capellon Pharmaceuticals,
Ltd.s
Rescon-MX®
(chlorpheniramine, methscopolamine and phenylephrine), Poly
Pharmaceuticals, Inc.s Poly Hist
Forte®
(chlorpheniramine, phenylephrine and pyrilamine) and Laser
Pharmaceuticals, LLCs
Dallergy®
(phenylephrine, chlorpheniramine and methscopolamine).
Over-the-counter products include well known brands such as
McNeil-PPC, Inc.s
Zyrtec®
(cetirizine hydrochloride) and Schering-Plough
Corporations
Claritin®
(loratadine), McNeil-PPC, Inc.s
Benadryl®
(diphenhydramine) and Schering-Plough Corporations
Chlor-Trimeton®
(chlorpheniramine). According to Wolters Kluwer Health, in 2007,
oral solid first generation antihistamine and antihistamine
combination products generated approximately 6.6 million
prescriptions. The ALLERX Dose Pack family of products is the
market leader among branded first generation antihistamine and
antihistamine combination products, generating approximately
284,000 prescriptions in 2007.
In addition to pharmacotherapy, such as antihistamines and
decongestants, there are two other principal treatment options
for allergic rhinitis: allergen avoidance and immunotherapy.
According to AAAAI, allergen avoidance is the best treatment,
but it is often difficult to avoid the allergy trigger.
Immunotherapy, commonly referred to as allergy shots, is a
treatment that stimulates the immune system to fight allergies
through an immunization procedure beginning with injections of
purified extract substances that are causing the allergic
reactions. Immunotherapy can be very effective and can decrease
the sensitivity of the patient to allergens, but it is time
consuming for the patient and can be costly.
Antihistamine therapy typically does not help with congestion,
and first generation antihistamines are associated with the side
effect of sedation. Decongestants aid with the symptom of
congestion but do not help block histamines and are commonly
associated with the side effects of insomnia, anxiety and
increased heart rate.
Benefits
and Description of ALLERX Dose Packs
ALLERX Dose Packs use a patented dosing regimen and are designed
so that side effects, such as insomnia with decongestants and
drowsiness with first generation antihistamines, to the extent
they are experienced, are most likely to occur at times that
these side effects do not inconvenience the patient.
Cornerstone currently markets the following ALLERX Dose Pack
products.
ALLERX 10
Dose Pack/ALLERX 30 Dose Pack
These ALLERX Dose Pack products are available in
ten-day and
30-day
regimens and consist of a morning, or AM, dose and an evening,
or PM, dose. The AM dose contains 120 mg of the
decongestant pseudophedrine, which also helps patients stay
alert during the day, and 2.5 mg of the drying agent
methscopolamine. The PM dose contains 8 mg of the
antihistamine chlorpheniramine, which helps patients sleep
better at night by relieving their symptoms and making them
drowsy, 10 mg of the decongestant phenylephrine and
2.5 mg of methscopolamine.
195
ALLERX
Dose Pack DF/ALLERX Dose Pack DF 30
ALLERX Dose Pack DF is a decongestant-free dosing regimen
suitable for patients who cannot tolerate a decongestant but
need the antihistamine and drying agent to relieve their
symptoms. ALLERX Dose Pack DF is available in
ten-day and
30-day
regimens and consists of an AM dose and a PM dose. The AM dose
contains 4 mg of the antihistamine chlorpheniramine and
2.5 mg of the drying agent methscopolamine. The PM dose
contains 8 mg of chlorpheniramine and 2.5 mg of
methscopolamine.
ALLERX
Dose Pack PE/ALLERX Dose Pack PE 30
ALLERX Dose Pack PE substitutes the decongestant phenylephrine
for pseudoephedrine in the AM dose. ALLERX Dose Pack PE may be
preferred by physicians who prefer phenylephrine or who are
concerned that products containing pseudoephedrine have been
widely reported by law enforcement personnel as having been used
as component ingredients for the illegal manufacture of
methamphetamines. It is also suitable for patients who cannot
tolerate pseudoephedrine. ALLERX Dose Pack PE is available in
ten-day and
30-day
regimens and consists of an AM dose and a PM dose. The AM dose
contains 40 mg of phenylephrine and 2.5mg of the drying
agent methscopolamine. The PM dose contains 10 mg of
phenylephrine, 8 mg of the antihistamine chlorpheniramine
and 2.5mg of methscopolamine.
Proprietary
Rights
Cornerstone has an exclusive license from Pharmaceutical
Innovations to market ALLERX 10 Dose Pack, ALLERX 30 Dose Pack,
ALLERX Dose Pack PE and ALLERX Dose Pack PE 30 within the
United States under an issued U.S. patent with claims
to a prepackaged, therapeutic dosing regimen that includes a
less sedating first dose containing a nasal decongestant, a
second dose containing an antihistamine and an attenuated dosage
of nasal decongestant, indicia for distinguishing between the
first and second doses, administration instructions that teach
the coordinated use of the first and second doses and a
pharmaceutical dispensing container containing the first and
second doses and incorporating the indicia and coordinating
instructions. This patent expires in 2021. On June 13,
2008, the U.S. Patent and Trademark Office received a
request from Vision Pharma, LLC, or Vision, to re-examine
this patent. These re-examination proceedings are more fully
discussed in the section entitled Cornerstones
Business Legal Proceedings beginning on
page 232 of this proxy statement/prospectus.
In addition, Cornerstone has applied for a U.S. patent
that, if issued, would include claims to ALLERX Dose Pack
DFs and ALLERX Dose Pack DF 30s AM and PM dosing
regimen and method of treating a rhinitic condition using an
antihistamine and an anticholinergic in both doses. This patent
application has been published and is currently pending. If
issued, this patent would expire in 2026.
Other
Products
HYOMAX
Overview
The HYOMAX line of products consists of generic formulations of
four antispasmodic medications containing the API hyoscyamine
sulfate, an anticholinergic, which may be prescribed for
functional intestinal disorders to reduce symptoms such as those
seen in mild dysenteries and diverticulitis. The HYOMAX line of
products can also be used to control gastric secretion, visceral
spasm and hypermotility in cystitis, pylorospasm and associated
abdominal cramps. Along with appropriate analgesics, HYOMAX
products may be prescribed for symptomatic relief of biliary and
renal colic and as a drying agent in the relief of symptoms of
acute rhinitis. HYOMAX products may also be used as adjunctive
therapy in the treatment of peptic ulcer and irritable bowel
syndrome, acute enterocolitis and other functional
gastrointestinal disorders. Cornerstone launched the first
HYOMAX product, HYOMAX SL 0.125 mg tablets, in May 2008,
followed by HYOMAX SR 0.375 mg tablets and HYOMAX FT
0.125 mg chewable melt tablets in June 2008 and HYOMAX DT
0.125 mg immediate release/0.25 mg sustained release biphasic
tablets in July 2008. Cornerstone markets the HYOMAX line of
products through its Aristos subsidiary. Cornerstone formed
Aristos to launch authorized generic
196
versions of Cornerstones products that become subject to
generic competition and to acquire or in-license generic
versions of products with little or no generic competition, such
as the HYOMAX line of products, that Cornerstones
management believes offer attractive returns on investment,
regardless of whether such products are used to treat
respiratory ailments.
Market
Opportunity and Other Treatment Options
Antispasmodics are often a first-line treatment for patients
with irritable bowel syndrome, or IBS, because they offer a
safe, cost-effective method of relieving abdominal pain and
diarrhea by preventing or slowing contractions in the bowel.
According to the American Academy of Family Physicians, 10% to
15% of the U.S. population is affected by IBS to some degree.
According to the American Physical Therapy Association, more
than 17 million Americans have urinary incontinence,
although only 15% seek treatment. Patients with urinary
incontinence may find that antispasmodics relax the bladder
muscle and relieve spasms.
The U.S. antispasmodic market is fairly fragmented with
approximately 30 branded products and 20 generic products.
According to Wolters Kluwer Health, in 2007, in the United
States the antispasmodic market generated approximately
25 million prescriptions, including approximately
16 million for urinary incontinence antispasmodics, such as
Pfizer Inc.s
Detrol®
LA (tolterodine tartrate), Astellas Pharmaceuticals, Inc. and
GlaxoSmithKlines
VESIcare®
(solifenacin) and the generic formulations of Ortho-McNeil
Pharmaceutical, Inc.s
Ditropan®
and
Ditropan®
XL (oxybutynin), approximately 3.6 million for synthetic
gastrointestinal antispasmodics, such as the generic
formulations of Axcan Pharma, Inc.s
Bentyl®
(dicyclomine) and Kenwood Therapeutics
Pamine®
(methscopolamine bromide) and approximately 4.4 million for
belladonna and derivatives gastrointestinal antispasmodics, such
as the HYOMAX products, and generic formulations of Alaven
Pharmaceutical LLCs
Levsin®
(hyoscyamine sulfate) and
Levbid®
(hyoscyamine sulfate) products and of PBM Pharmaceuticals
Donnatal®
(belladonna alkaloids/phenobarbital). All brands in the
belladonna and derivatives gastrointestinal antispasmodics
market have a generic formulation. Some newer products for IBS,
such as Prometheus Laboratories, Inc.s
Lotronex®
(alosetron) and Novartis Pharmaceuticals Corporations, or
Novartis,
Zelnorm®
(tegaserod), have been subject to FDA risk assessment. Lotronex
was introduced and voluntarily withdrawn from the market in 2000
due to concerns of the severity and number of adverse results
from the use of the product, but was reintroduced to the market
in 2002 after Novartis agreed with the FDA to institute a
Patient-Physician Agreement program. Zelnorm was introduced to
the market in 2002 and similarly voluntarily withdrawn from the
market in 2007 after findings of an increased risk of serious
cardiovascular adverse events associated with the use of the
drug.
Benefits
of HYOMAX
Once absorbed, hyoscyamine sulfate, the API in the HYOMAX
products, disappears rapidly from the blood and is distributed
throughout the entire body. The majority of hyoscyamine sulfate
is excreted in the urine unchanged within the first
12 hours and only traces of hyoscyamine sulfate are found
in the breast milk of nursing mothers. The HYOMAX line of
products offers patients a cost-effective treatment option for a
variety of gastrointestinal problems, such as IBS and urinary
incontinence and may be preferred by physicians concerned about
the potential serious side effects associated with newer
products such as Zelnorm.
Proprietary
Rights
Cornerstone has an exclusive license from Sovereign
Pharmaceuticals, Ltd., or Sovereign, to market and distribute
three hyoscyamine sulfate products in the United States through
April 2011. Cornerstone is marketing and distributing HYOMAX DT
tablets in the United States pursuant to a verbal agreement
between Cornerstone and Capellon Pharmaceuticals, Ltd., or
Capellon, a wholly owned subsidiary of Sovereign, which the
parties anticipate will be superseded by a written license
agreement that is currently being negotiated and finalized
between Cornerstone and Capellon. Cornerstone filed for the
trademark to HYOMAX in May 2008 for use in connection with
marketing this product line.
197
ALLERX
ALLERX-D
ALLERX-D contains 120 mg of the decongestant
pseudoephedrine and 2.5 mg of the drying agent
methscopolamine. Packaged in bottles, ALLERX-D provides patients
symptomatic relief of the symptoms of allergic rhinitis without
an antihistamine.
ALLERX
Suspension
ALLERX Suspension is an oral, liquid decongestant and
antihistamine combination that is indicated for patients six
years of age or older for symptomatic relief of the nasal
inflammation and nasal congestion associated with the common
cold, sinusitis and other upper respiratory tract conditions.
Each 5 ml dose contains 7.5 mg of the decongestant
phenylephrine tannate and 3 mg of the antihistamine
chlorpheniramine tannate.
RESPIVENT
Cornerstone currently markets two RESPIVENT products,
RESPIVENT-D and RESPIVENT DF Dose Pack. RESPIVENT-D is a
generic formulation of ALLERX-D. RESPIVENT DF Dose Pack is a
generic formulation of ALLERX Dose Pack DF, which, like ALLERX
Dose Pack DF, is available in ten-day and 30-day regimens.
Propoxyphene/Acetaminophen
Products
Cornerstones propoxyphene/acetaminophen product line
includes BALACET 325, APAP 325 and APAP 500. Cornerstone
acquired the rights to each of these products from Vintage.
BALACET
325
BALACET 325 is indicated for the relief of mild to moderate
pain, either when pain is present alone or when it is
accompanied by a fever. BALACET 325 contains 100 mg of
propoxyphene napsylate and 325 mg of acetaminophen.
Cornerstone licensed rights to the formulation of BALACET 325
from Vintage in 2004. Cornerstones net sales of BALACET
325 were $4.4 million in 2007. BALACET 325 is currently
promoted by Atley Pharmaceuticals under a co-promotion agreement
with Cornerstone.
APAP
325
APAP 325 is a generic formulation of BALACET 325 and indicated
for the relief of mild to moderate pain. Each tablet contains
100 mg of propoxyphene napsylate and 325 mg of acetaminophen.
APAP 325, along with any other generic formulation of
BALACET 325, is currently promoted by Atley Pharmaceuticals
under a co-promotion agreement with Cornerstone.
APAP
500
APAP 500 is a generic formulation of Xanodyne Pharmaceuticals,
Inc.s Darvocet a500 and indicated for the relief of mild
to moderate pain. Each tablet contains 100 mg of
propoxyphene napsylate and 500 mg of acetaminophen.
198
Product
Development Pipeline
Cornerstones product development pipeline consists of
three SPECTRACEF line extensions and a portfolio of additional
product candidates based on marketed drug compounds. The
following table sets forth additional information regarding
Cornerstones product candidates.
|
|
|
|
|
|
|
|
|
Product
|
|
|
|
|
|
Method of
|
|
|
Candidate
|
|
Regulatory Status
|
|
Therapeutic Class
|
|
Administration
|
|
Primary Indication(s)
|
|
Spectracef Line Extensions
|
|
|
|
|
|
|
SPECTRACEF 400 mg
|
|
sNDA approved in July 2008
|
|
Antibiotic
|
|
Oral tablet Twice-daily dosing
|
|
Acute bacterial exacerbation of chronic bronchitis;
community-acquired pneumonia
|
SPECTRACEF Once Daily
|
|
NDA submission targeted in 2010
|
|
Antibiotic
|
|
Oral tablet Once-daily Dosing
|
|
Acute bacterial exacerbations of chronic bronchitis with COPD
|
SPECTRACEF Suspension
|
|
NDA submission for pharyngitis and tonsillitis targeted in 2009;
sNDA submission for acute otitis media targeted in 2010
|
|
Antibiotic
|
|
Oral suspension
|
|
Pharyngitis and tonsillitis; acute otitis media
|
Other Product Candidates
|
|
|
|
|
|
|
CBP 058
|
|
NDA submission targeted in 2010
|
|
Antihistamine and anticholinergic combination
|
|
Oral tablet
|
|
Temporary relief of symptoms associated with allergic rhinitis
|
CBP 067
|
|
Regulatory submission targeted in 2009
|
|
Antihistamine and antitussive combination
|
|
Oral suspension
|
|
Temporary relief of symptoms associated with cough and upper
respiratory symptoms associated with allergies or a cold
|
CBP 069
|
|
Regulatory submission targeted in 2009
|
|
Antihistamine and antitussive combination
|
|
Oral suspension
|
|
Temporary relief of symptoms associated with cough and upper
respiratory symptoms associated with allergies or a cold
|
SPECTRACEF
Line Extensions
Overview
SPECTRACEF is an integral part of Cornerstones current
sales strategy, as well as its sales growth strategy for the
future. To protect and expand SPECTRACEFs market share,
Cornerstone has developed SPECTRACEF 400 mg, a higher dose
tablet for the adult market, and is developing Spectracef Once
Daily, a new oral solid dosage form, and SPECTRACEF Suspension,
an oral suspension for the pediatric market.
SPECTRACEF
400 mg
SPECTRACEF 400 mg is a single 400 mg tablet,
twice-daily dosage of SPECTRACEF for which Cornerstone received
approval from the FDA in July 2008. Cornerstone believes that
patients will find taking one 400 mg tablet twice daily to
be more convenient than taking two SPECTRACEF 200 mg
tablets twice daily. SPECTRACEF 400 mg is indicated for
acute bacterial exacerbation of chronic bronchitis and
community-acquired pneumonia. Cornerstone expects to launch
SPECTRACEF 400 mg in the fourth quarter of 2008.
199
SPECTRACEF
Once Daily
SPECTRACEF Once Daily is a single tablet, once-daily dosage of
SPECTRACEF. Cornerstone filed an IND with the FDA in July 2008
for SPECTRACEF Once Daily, which has since been approved by the
FDA, and expects to commence a clinical trial in the fourth
quarter of 2008 to evaluate the pharmacokinetic profile of a
formulation of SPECTRACEF Once Daily developed by Patheon Inc.
If the results of this pharmacokinetic trial is favorable,
Cornerstone expects to commence two clinical trials in the first
quarter of 2009 to evaluate the safety and efficacy of this
product candidate designed to form the basis for an NDA
submission to the FDA in 2010 for the treatment of acute
bacterial exacerbations of chronic bronchitis with COPD.
Cornerstone is designing this trial as superiority, randomized
studies of patients with acute bacterial exacerbation of chronic
bronchitis. A superiority trial must show that the test product
is statistically better than the comparator, which may be a
placebo. Cornerstone anticipates that, if approved based on the
results of these clinical trials, the FDA will grant SPECTRACEF
Once Daily a three-year period of marketing exclusivity under
the Hatch-Waxman Act.
Cornerstone believes that the once-daily dosage of this product
candidate would be more convenient for patients than taking
SPECTRACEF twice daily and would increase compliance. Among oral
solid cephalosporins, only Cedax and Suprax have a once-daily
dosage. Most macrolides and quinolones also have a once-daily
dosage option.
SPECTRACEF
Suspension
SPECTRACEF Suspension is an oral, liquid suspension of
SPECTRACEF. Cornerstone expects to submit an NDA in 2009 for use
of this product candidate by children with pharyngitis or
tonsillitis based on the results of a number of previously
conducted clinical trials. Two of these clinical trials compared
the safety and efficacy of orally administered cefditoren
pivoxil with an FDA-approved product, penicillin VK, using a
non-inferiority design. Each clinical trial was a Phase III,
randomized, double-blind, active-controlled, parallel-group,
multicenter study of outpatients with streptococcal pharyngitis
or tonsillitis. In the first clinical trial, 503 patients
received either cefditoren pivoxil or penicillin VK. Of these, a
total of 364 patients were considered microbiologically
evaluable for efficacy at a post-therapy visit and
352 patients were microbiologically evaluable for efficacy
at a subsequent
follow-up
visit. All 503 patients were included in the safety
analyses. In the second clinical trial, 508 patients
received either cefditoren pivoxil or penicillin VK. Of these, a
total of 364 patients were considered microbiologically
evaluable for efficacy at a post-therapy visit and
355 patients were microbiologically evaluable for efficacy
at a subsequent
follow-up
visit. All 508 patients were included in the safety
analyses. In each of these trials, cefditoren pivoxil was well
tolerated with no significant adverse events reported. In the
first trial, both treatment regimens were effective in resolving
the clinical signs and symptoms of streptococcal pharyngitis or
tonsillitis, but cefditoren pivoxil was statistically superior
to penicillin VK in eradicating Streptococcus pyogenes.
In the second trial, cefditoren pivoxil was equivalent to
pencillin VK in resolving the clinical signs and symptoms of
streptococcal pharyngitis or tonsillitis and in eradicating
Streptococcus pyogenes.
In addition, Cornerstone expects to commence additional clinical
trials in 2009 for SPECTRACEF Suspension in acute otitis media
and submit an sNDA for this indication in 2010. Cornerstone is
designing these clinical trials as superiority, randomized
studies of patients with acute otitis media to evaluate the
safety and efficacy of SPECTRACEF Suspension. If its NDA is
approved, Cornerstone will have the option of launching
SPECTRACEF Suspension for the pharyngitis and tonsillitis
indications while the clinical trials in acute otitis media are
ongoing. Cornerstone anticipates that, if approved based on the
results of these clinical trials, the FDA will grant SPECTRACEF
Suspension a three-year period of marketing exclusivity under
the Hatch-Waxman Act for acute otitis media.
According to Wolters Kluwer Health, second and third generation
oral cephalosporin suspensions generated approximately
7.8 million prescriptions in 2007 and approximately
$750 million in sales, including suspension products
containing cefdinir that generated approximately
5.6 million prescriptions and approximately
$580 million in sales.
200
According to Wolters Kluwer Health, during the 54 week
period ending May 16, 2008, pediatric specialists generated
approximately 5 million second and third generation oral
cephalosporin suspension prescriptions, or 64% of these
prescriptions, and family practice specialists generated
approximately 1.4 million prescriptions, or approximately
17% of these prescriptions.
Proprietary Rights
SPECTRACEF 400 mg, SPECTRACEF Once Daily and SPECTRACEF
Suspension are covered by the same U.S. patents as
SPECTRACEF 200 mg. Meiji also has applied for a U.S. patent
that, if issued, would include claims to enhanced oral
absorptivity for SPECTRACEF Once Daily. This patent application
has been published and is currently pending. If issued, this
patent would expire in 2023. Cornerstones rights to market
and develop SPECTRACEF 400 mg, SPECTRACEF Once Daily and
SPECTRACEF Suspension are subject to its license arrangements
with Meiji.
Other
Product Candidates
Methscopolamine/Antihistamine
Product Candidate CBP 058
Overview
and Development Status
CBP 058 is a combination methscopolamine and antihistamine
product candidate that Cornerstone is developing for the
treatment of symptoms of allergic rhinitis. In 2007, Cornerstone
met with the FDA regarding its plans to develop a
methscopolamine and antihistamine product. Cornerstone plans to
file an IND and to commence a clinical trial for the
methscopolamine/antihistamine product candidate, CBP 058,
in the first quarter of 2009 and submit an NDA in 2010.
Cornerstone expects that the clinical studies for this product
candidate will include a pharmacokinetic study in both fed and
fasted states to establish a kinetic profile, as well as at
least one clinical study in patients with allergic rhinitis to
demonstrate safety and efficacy. Performing the pharmacokinetic
study on both patients who have eaten a meal within the past
hour and patients who have fasted overnight allows for a
determination of the effect of food on the absorption of the
drug. Because this product candidate is a combination product,
the studies would compare the test product to its two individual
components, and the test product must be statistically superior
to both. If approved, Cornerstone believes this product
candidate would be the first FDA-approved product containing
methscopolamine with an indication associated with allergic
rhinitis.
Market
Opportunity and Current Treatment Options
According to AAAAI, allergic rhinitis has a strong link to other
respiratory diseases including chronic sinusitis, middle ear
infections, nasal polyps and bronchial asthma. The connection to
bronchial asthma has caused great concern among allergists and
immunologists. For example, a March 1999 article in Discover
magazine described an analysis of over 1,200 asthmatics,
approximately half of whom had rhinitis and half whom did not,
in which those who had both rhinitis and asthma were more likely
to have nighttime awakening due to asthma, 19.6 percent
compared to 11.8 percent, to miss work because of asthma,
24.1 percent compared to 12.1 percent, and to meet the
criteria for moderate to severe asthma,
60.2 percent compared to 51.2 percent. Additionally,
asthmatics with rhinitis require more potent medications to
control their symptoms. One potential explanation is that severe
post-nasal drip triggers episodes of asthma. For example,
researchers have found that inflammatory chemicals commonly
found in the noses of people with allergic rhinitis drip into
the lungs while they sleep, thus causing asthma to worsen.
According to Wolters Kluwer Health, oral solid methscopolamine
combination products for the treatment of symptoms of
respiratory diseases and allergies generated approximately
1.6 million prescriptions in 2007, representing a growth
rate of 15% compared to 2006. In addition, second and third
generation antihistamine and antihistamine combination products
generated a total of approximately 52 million prescriptions
in 2007.
Current treatments for the symptoms of allergic rhinitis consist
of both prescription and over-the-counter products. Prescription
products include large second generation antihistamine branded
families of products, such as Sanofi-Aventis
U.S. LLCs
Allegra®
(fexofenadine), third generation antihistamine branded families
of
201
products, such as UCB, Inc. and Sanofi-Aventis
U.S. LLCs
Xyzal®
(levocetirizine) and Schering-Plough Corporations
Clarinex®
(desloratadine), and first generation antihistamine and
antihistamine combination products, most of which are generic
formulations. Over-the-counter products include first generation
antihistamines, such as McNeil-PPC, Inc.s
Benadryl®
(diphenhydramine) and Schering-Plough Corporations
Chlor-Trimeton®
(chlorpheniramine), and second generation antihistamines, such
as Claritin and Zyrtec.
Benefits
of CBP 058
If approved, CBP 058 will combine a less sedating antihistamine
to combat the histamine released during an allergic reaction
with an anticholinergic to relieve symptoms of post-nasal drip
and other mucous secretions. This combination of therapies is
not currently commercially available in a single tablet. Less
sedating second and third generation prescription antihistamines
do not have an anticholinergic option, and first generation
antihistamine and anticholinergic combination products currently
available on the market are more sedating.
Cornerstone anticipates that, if approved based on the results
of clinical trials that it plans to conduct, the FDA will grant
CBP 058 a three-year period of marketing exclusivity under the
Hatch-Waxman Act. In addition, based on FDA precedent with
respect to DESI II drugs that are clinically tested and
submitted to the FDA for approval, Cornerstone expects that the
FDA would require other methscopolamine products, including the
first generation antihistamine and methscopolamine combinations
currently available, to be removed from the market after a grace
period. In such event, Cornerstone believes that CBP 058 would
be the only methscopolamine product indicated for the symptoms
of allergic rhinitis on the market that physicians could
prescribe.
Proprietary
Rights
Cornerstone has licensed the rights to market CBP 058 utilizing
the Dynamic Variable
Release®
technology licensed from Neos. Dynamic Variable Release
technology is covered under a pending U.S. patent
application that if issued would expire in 2024. This licensed
technology allows Cornerstone to formulate CBP 058 with one or
more active pharmaceutical ingredients that require immediate
activation followed by extended release of the remaining active
pharmaceutical ingredients.
Hydrocodone
Cough Suppressant Product Candidates CBP 067 and CBP
069
Overview
and Development Status
CBP 067 and CBP 069 are extended-release antihistamine and
antitussive, or cough suppressant, combination product
candidates currently in development. Cornerstone expects that
both of these product candidates will require only
pharmacokinetic studies for approval. Pharmacokinetic studies
are designed to establish the kinetic profile of the test
product and compare this profile to the profile of already
approved products. Cornerstone plans to submit applications for
marketing approval for these product candidates in 2009 and, if
approved, commercially launch the product candidates in 2010. If
approved, these product candidates will compete directly in the
hydrocodone cough suppressant market.
Market
Opportunity and Current Treatment Options
Cough can adversely affect quality of life, leading patients to
seek medical attention. Health care providers have a variety of
treatment options. Non-productive cough is commonly treated with
antitussive and antitussive combinations that do not contain an
expectorant, such as guaifenesin. Antitussive combination
products that treat non-productive coughs typically combine an
antitussive, including hydrocodone, codeine or dextromethorphan,
with antihistamines, including chlorpheniramine or
brompheniramine, or decongestants, including pseudoephedrine or
phenylephrine. Dextromethorphan is available in both
over-the-counter and prescription formulations. Hydrocodone, a
centrally acting opioid antitussive, has been shown to be as
effective as codeine but without gastrointestinal side effects.
According to Wolters Kluwer Health, in 2007, there were over
26 million prescriptions generated for oral antitussive and
antitussive combinations without an expectorant. Of these,
nearly 4.8 million were for
202
Phenergan with codeine, which is available as a generic, and
almost 3 million for UCB Pharmas
Tussionex®
(hydrocodone polistirex and chlorpheniramine polistirex), which
is only available as a brand.
On September 28, 2007, the FDA announced its intention to
take enforcement action against companies marketing unapproved
prescription drug products containing the narcotic hydrocodone.
The action did not affect hydrocodone formulations that have FDA
approval. Only eight cough suppressants containing hydrocodone
were approved by the FDA as of September 15, 2008. Any
company marketing unapproved hydrocodone drug products was
required to cease manufacturing such products on or before
December 31, 2007, and cease further shipment in interstate
commerce on or before March 31, 2008, although pharmacies
could continue to sell their remaining inventory.
According to Wolters Kluwer Health, U.S. sales of
prescription hydrocodone cough suppressants were
$300 million in 2007, with over 9.75 million
prescriptions written. Approximately 55% of those prescriptions
were for products not approved by the FDA.
In addition, 66% of the sales and 30% of the prescriptions
written in 2007 for hydrocodone cough suppressants were
generated by Tussionex, an approved extended-release hydrocodone
and antihistamine combination. With limited availability of
approved hydrocodone products, Tussionex prescriptions have
increased dramatically in 2008. According to Wolters Kluwer
Health, in April 2008, the month after the FDA enforcement
action went into effect, Tussionex prescriptions grew 34% and
sales grew 46% as compared to April 2007. Despite being approved
by the FDA in 1987, Tussionex does not face any generic
competition and has no patent protection.
Benefits
of CBP 067 and CBP 069
Most antitussive and antitussive combination products that are
currently marketed are in an immediate-release formulation,
meaning they must be dosed every four to six hours, which can be
inconvenient. For example, patients may not be able to sleep
through the night because their antitussive is not effective for
more than four hours. Cornerstone believes that CBP 067 and CBP
069 could improve patients quality of life by providing
more convenient twice-daily, longer lasting dosing.
Proprietary
Rights
Cornerstone has licensed the rights to market CBP 067 and CBP
069 utilizing the Dynamic Variable Release technology and the
Dynamic Time Release
Suspensiontm
technology of Neos and the drug resin complex technology of
Coating Place, Inc., or Coating Place. Cornerstone expects that
these licensed technologies will allow Cornerstone to formulate
CBP 067 and CBP 069 with one or more active pharmaceutical
ingredients that require immediate activation followed by a
sustained timed release of the remaining active pharmaceutical
ingredients over a
12-hour
period. Neoss Dynamic Variable Release technology is
covered under a pending U.S. patent application that if issued
would expire in 2024. Neoss Dynamic Time Release
Suspension technology is covered under a pending U.S. patent
application that if issued would expire in 2025. Coating
Places drug resin complex technology is covered under a
pending U.S. patent application that if issued would expire in
2025.
Sales and
Marketing; Co-promotion Agreements
Sales
and Marketing
Cornerstone has built a commercial organization, consisting at
September 15, 2008 of a respiratory-focused sales team that
includes 49 sales representatives, five sales managers and one
national sales director. Cornerstones sales team is
supported by marketing, market research and commercial
operations professionals who are responsible for developing
Cornerstones brands, implementing strategies and tactical
plans for sales force execution, performing business analytics,
leveraging commercial technology, overseeing sales operations
and training Cornerstones sales representatives.
Cornerstone representatives currently call on high-prescribing,
respiratory-focused physicians and key retail pharmacies.
Cornerstone believes this highly specialized approach provides
it with the opportunity for greater
203
access to this group of health care professionals. It also
increases Cornerstones market coverage and frequency of
detailing visits to this target audience. All representatives
are required to provide management with quarterly business plans
to ensure all resources are being utilized effectively.
Cornerstone currently maintains a one to two-week call cycle for
all promoted products and records calls into an internally built
intranet system for information management.
Cornerstone believes that the current market opportunity for its
products and the future opportunity for its pipeline of product
candidates, if approved, will likely warrant the need for sales
force expansion. Cornerstone expects to commence this expansion
as FDA approval of a product candidate is obtained or expected
to be obtained in the near future, revenues expand or
Cornerstone obtains additional funding.
Cornerstone seeks to differentiate its products from its
competitors by emphasizing the clinical advantages and favorable
side effect profile for patients who are suffering from
respiratory diseases or allergies. Cornerstones marketing
programs include patient co-payment assistance, health care
provider education and information to further support patient
compliance. In addition, Cornerstone has established a
respiratory advisory board with varying specialties to assist in
developing its corporate strategy for both its products and
product candidates. National conventions and publication plans
are also integral aspects of Cornerstones overall
marketing plan.
Co-promotion
Agreements
Cornerstone seeks to enter into co-promotion arrangements to
enhance its promotional efforts and sales of its products.
Cornerstone may enter into co-promotion agreements with respect
to its products that are not aligned with Cornerstones
respiratory focus or when it lacks sufficient sales force
representation in a particular geographic area.
Co-promotion
Agreement with SJ Pharmaceuticals
In March 2007 and June 2007, Cornerstone entered into
co-promotion agreements with SJ Pharmaceuticals, LLC, or SJ
Pharmaceuticals, to co-promote the ALLERX Dose Pack family of
products and SPECTRACEF, respectively. Under these agreements,
Cornerstone pays SJ Pharmaceuticals fees based on a percentage
of the net profits of the ALLERX Dose Pack and SPECTRACEF
products sold above a specified baseline based upon
prescriptions by assigned, targeted prescribers within assigned
sales territories. These targeted prescribers are mutually
agreed upon by Cornerstone and SJ Pharmaceuticals prior to the
start of each quarter.
SJ Pharmaceuticals sales representatives are located
primarily in the southeastern United States.
SJ Pharmaceuticals is required under the
co-promotion
agreements to maintain a trained sales force of at least
20 representatives to detail ALLERX Dose Pack and
SPECTRACEF products and is required to maintain an incentive
compensation plan to encourage superior performance by its sales
representatives. SJ Pharmaceuticals promotes the ALLERX
Dose Pack and SPECTRACEF products to primary care physicians,
allergists, otolaryngologists, physician assistants, nurse
practitioners, pharmacists and other specialists in
SJ Pharmaceuticals assigned sales territories.
Because SJ Pharmaceuticals only promotes to prescribers on
its assigned, targeted prescriber list, Cornerstone sales
representatives have no overlapping prescribers.
The ALLERX co-promotion agreement expires on March 28,
2010, unless extended by mutual agreement of the parties. The
SPECTRACEF co-promotion agreement expires on June 13, 2010,
unless extended by mutual agreement of the parties. Each
co-promotion agreement contains customary provisions permitting
termination based upon bankruptcy, insolvency and breach of the
agreement. Each co-promotion agreement also can be terminated by
either party without cause upon 60 days advance
notice. Additionally, Cornerstone may terminate the SPECTRACEF
co-promotion agreement at any time if SJ Pharmaceuticals is
unable to increase SPECTRACEF sales above the specified
baseline. If SJ Pharmaceuticals terminates a co-promotion
agreement based upon Cornerstones breach of such
agreement, or Cornerstone terminates a co-promotion agreement
without cause or, in the case of the SPECTRACEF co-promotion
agreement, Cornerstone terminates because SJ Pharmacueticals is
unable to increase SPECTRACEF sales above the specified
baseline, then SJ Pharmaceuticals is entitled to receive a
termination fee for the six months following such termination,
paid on
204
a quarterly basis, equal to the average monthly amount paid by
Cornerstone to SJ Pharmaceuticals during the six months
immediately preceding such termination.
Co-promotion
Agreement with Atley Pharmaceuticals
In April 2007, Cornerstone entered into a co-promotion agreement
with Atley Pharmaceuticals to co-promote BALACET 325. In July
2008, Cornerstone and Atley Pharmaceuticals agreed to amend the
co-promotion
agreement to include APAP 325 and any other generic
formulation of BALACET 325. Under the agreement,
Cornerstone pays Atley Pharmaceuticals fees based on a
percentage of the net profits from sales of BALACET 325, and any
generic formulations thereof marketed by Cornerstone, above a
specified baseline within assigned sales territories. The
parties have agreed to revise the baseline
semi-annually
to ensure that the baseline is attainable using commercially
reasonable efforts.
Atley Pharmaceuticals sales representatives are mainly
located in the southeastern, southwestern and midwestern
United States. Atley Pharmaceuticals is required under the
co-promotion agreement to maintain a trained sales force of at
least 40 representatives to detail BALACET 325 and generic
formulations thereof and an incentive compensation plan to
encourage superior performance by its sales representatives.
Atley Pharmaceuticals promotes BALACET 325 and generic
formulations thereof to pain specialists and primary care
providers and other specialties within Atley
Pharmaceuticals assigned sales territories. According to
Wolters Kluwer Health, there has been a 35% increase in bottles
dispensed from the first half of 2007 to the second half of 2007
within the sales territories where Atley Pharmaceuticals
sales representatives promote the product.
The co-promotion agreement expires on April 2, 2010, unless
extended by mutual agreement of the parties. In addition to
customary provisions permitting termination, either party may
terminate the co-promotion agreement without cause upon
60 days advance notice or upon the failure of the
parties to agree on a revised specified baseline during the
semi-annual
review process. If Atley terminates the co-promotion agreement
based upon Cornerstones breach of such agreement,
Cornerstone terminates the co-promotion agreement without cause,
or either party terminates because the parties cannot agree upon
a revised specified baseline, then Atley is entitled to receive
a termination fee for the six months following such termination,
paid on a quarterly basis, equal to the average monthly
detailing fee paid by Cornerstone to Atley during the six months
immediately preceding such termination.
Trade,
Distribution and Reimbursement
Trade
Sales and Distribution
Cornerstones customers consist of drug wholesalers, retail
drug stores, mass merchandisers and grocery store pharmacies in
the United States. It primarily sells products directly to drug
wholesalers, which in turn distribute the products to retail
drug stores, mass merchandisers and grocery store pharmacies.
Cornerstones top three customers, which represented 91% of
gross sales in 2007, are all drug wholesalers and are listed
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Gross Sales
|
|
Customer
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Cardinal Health
|
|
|
43.2
|
%
|
|
|
36.7
|
%
|
|
|
45.1
|
%
|
McKesson
|
|
|
33.7
|
%
|
|
|
37.6
|
%
|
|
|
30.8
|
%
|
AmerisourceBergen
|
|
|
13.9
|
%
|
|
|
8.5
|
%
|
|
|
9.6
|
%
|
Consistent with industry practice, Cornerstone maintains a
returns policy that allows its customers to return products
within a specified period prior and subsequent to the expiration
date. Occasionally, Cornerstone may also provide additional
discounts to some customers to ensure adequate distribution of
its products.
Cornerstones trade distribution group actively markets
Cornerstones products to authorized distributors through
regular sales calls. This group has many years of experience
working with various industry distribution channels. Cornerstone
management believes that its trade distribution group
significantly enhances Cornerstones commercial performance
by ensuring product stocking in major channels across the
country;
205
continued
follow-up
with accounts and monitoring of product performance; successful
product launch strategies; and partnering with customers on
other value-added programs. Cornerstones active marketing
effort is designed to ensure proper distribution of its products
so that patients prescriptions can be filled with the
Cornerstone products that health care professionals prescribe.
Cornerstone relies on DDN, a third party logistics provider, for
the distribution of Cornerstones products to drug
wholesalers, retail drug stores, mass merchandisers and grocery
store pharmacies. DDN ships Cornerstones products from its
warehouse in Memphis, Tennessee to Cornerstone customers
throughout the United States as orders are placed through
Cornerstones customer service center.
Reimbursement
In the U.S. market, sales of pharmaceutical products depend
in part on the availability of reimbursement to the patient from
third-party payors, such as government health administration
authorities, managed care providers and private insurance plans.
All of Cornerstones products are generally covered by
managed care and private insurance plans. The status or tier
within each plan varies but coverage is similar to other
products within the same class of drugs. For example, SPECTRACEF
is covered by private insurance plans similar to other marketed,
branded cephalosporins. Some Medicare Part D plans also
cover some or all of Cornerstones products, but the amount
and level of coverage varies from plan to plan. Cornerstone also
participates in the Medicaid Drug Rebate program with the
Centers for Medicare & Medicaid Services and submits
all of its products for inclusion in this program. Coverage of
Cornerstones products under individual state Medicaid
plans varies from state to state. Third-party payors are
increasingly challenging the prices charged for pharmaceutical
products and reviewing different cost savings efforts, which
could affect the reimbursement available for Cornerstones
products.
Manufacturing
Cornerstone currently outsources the manufacturing of all of its
commercially available products and the formulation development
of its product candidates for use in clinical trials to
FDA-approved third parties. Cornerstone intends to continue to
rely on third parties for its manufacturing requirements.
Cornerstone provides regulatory and quality guidance to and
oversight of its third-party manufacturers with respect to its
products. Cornerstone also provides regular product forecasts to
assist its third-party manufacturers with efficient production
planning. Where possible and commercially reasonable,
Cornerstone qualifies more than one source for manufacturing and
packaging of its products to manage the risk of supply
disruptions. In such circumstances, if one of Cornerstones
manufacturers or packagers were unable to supply
Cornerstones needs, Cornerstone would have an alternative
source available for those products.
While some of Cornerstones products do not have an
alternative manufacturer qualified due to exclusivity provisions
in the respective licensing agreements or based on other
commercial considerations, Cornerstone believes there are other
suppliers that could serve as replacements for the current
manufacturers if the need arose. However, qualifying such a
replacement manufacturer with the FDA could take a significant
amount of time, and, as a result, Cornerstone would not be able
to guarantee an uninterrupted supply of the affected product to
its customers.
Cornerstone has entered into supply agreements with third-party
manufacturers and packagers for each of its marketed products.
Depending on the finished product presentation, some of its
manufacturers also package the product. In other cases, the
manufacturer supplies the bulk form of the product and
Cornerstone packages
206
the product through a separate third party. Important
information about Cornerstones material manufacturing and
packaging agreements is summarized in the following table.
|
|
|
|
|
Manufacturer/ Packager
|
|
Product
|
|
Term of Agreement
|
|
Bayer
|
|
Bulk tablets for the ALLERX Dose Pack family of products
|
|
July 2007 to June 2010; renews for successive one-year terms
unless terminated by either party with six months prior
written notice.
|
|
|
|
|
|
Meiji
|
|
SPECTRACEF API
(cefditoren pivoxil)
|
|
October 2006 to September 2016; renews for successive one-year
terms unless terminated with six months prior written
notice.
|
|
|
SPECTRACEF 400 mg
|
|
Ten years from the launch date of the product.
|
|
|
|
|
|
Patheon
|
|
SPECTRACEF 200 mg finished product
|
|
Product ordered from time to time on a purchase order basis.
|
|
|
|
|
|
Vintage
|
|
BALACET 325 and APAP 325
|
|
July 2004 to June 2009; renew for one-year terms unless
terminated with one years prior written notice.
|
Several of Cornerstones products require the use of active
pharmaceutical ingredients regulated by the DEA under the
Controlled Substances Act. In these instances, DEA quota
requirements regulate the procurement of these active
pharmaceutical ingredients and products containing these active
pharmaceutical ingredients by the manufacturer and packager. It
is the responsibility of Bayer and Sovereign, the respective
primary and backup manufacturers of bulk tablets for ALLERX 10
Dose Pack, ALLERX 30 Dose Pack, ALLERX-D and RESPIVENT-D, Legacy
and Carton Service, the manufacturers of trade and sample
packaging for ALLERX 10 Dose Pack, ALLERX 30 Dose Pack, ALLERX-D
and RESPIVENT-D, and Vintage, the manufacturer of BALACET 325,
APAP 325 and APAP 500, to request the necessary quota allocation
from the DEA to meet Cornerstones forecasted production
requirements on an annual basis. However, the DEA has
significant discretion in deciding how to allocate controlled
substance quotas and whether to authorize a quota for
Cornerstone. This discretion presents a potential risk to
Cornerstones supply chain. Cornerstone and its suppliers
attempt to manage this risk through accurate product planning
and timely quota submissions with appropriate allocation
justifications to the DEA.
In producing Cornerstones products, Cornerstones
manufacturers and packagers are also held to the FDAs cGMP
requirements and other compliance regulations mandated by the
FDA, the DEA and other regulatory authorities.
Bayer
Toll Manufacturing Agreement for ALLERX Dose Pack
Overview
In June 2007, Cornerstone entered into a toll manufacturing
agreement with Bayer pursuant to which Bayer is obligated to
manufacture bulk tablets for the ALLERX Dose Pack family of
products, including ALLERX
PE-PM,
ALLERX
PE-AM,
ALLERX
DF-AM,
ALLERX PM and ALLERX AM, in quantities ordered by Cornerstone.
Fees
Under this agreement, Cornerstone paid Bayer a one time
set-up fee
and is obligated to pay for the units delivered to Cornerstone
pursuant to purchase orders delivered to Bayer.
207
Minimum
Purchase Requirements
An additional one-time cost of up to $135,000 will be due on
December 31, 2009 if Cornerstone fails to meet the minimum
annual purchase requirement of 27.0 million tablets per
year for 2008 and 2009.
Indemnification
Bayer agreed to indemnify Cornerstone against any breach of the
agreement or the quality agreement by Bayer or any act or
omission by Bayer in the performance of the agreement, except to
such extent such claim is the result of any act or omission by
Cornerstone relating to the performance of this agreement.
Cornerstone agreed to indemnify Bayer against any breach of the
agreement or the quality agreement by Cornerstone or the sale,
use, or distribution of the product or the finished product by
Cornerstone, except to such extent such claim is the result of
any act or omission by Bayer relating to the performance of this
agreement.
Term and
Termination
The term of the agreement extends to June 2010 and will be
automatically renewed for successive one-year terms unless
either party provides written notice of termination at least six
months prior to the end of the then current term. The Agreement
contains customary provisions permitting termination based upon
bankruptcy, insolvency and breach of the agreement. In addition,
Cornerstone may terminate the agreement upon 30 days
written notice in the event of a change of the site of
manufacture of any product to any site that has not been
approved by Cornerstone. If Bayer undergoes a change of control
as defined in the agreement, Cornerstone may terminate the
agreement upon 30 days notice to Bayer. If Cornerstone
terminates the agreement for any reason before June 1,
2009, other than for Bayers breach of the agreement,
Cornerstone shall be obligated to make an early termination
payment to Bayer. Finally, Cornerstone may terminate upon
30 days notice if a regulatory agency does not approve the
finished product for marketing, a regulatory agency withdraws
marketing approval or Cornerstone otherwise terminates the
commercial sale of finished product. If termination is initiated
by Bayer, any such termination shall not be effective until
Cornerstone has arranged for the product to be manufactured by
another contract manufacturer, not to exceed 18 months from
Bayers written notice of termination.
Meiji
License and Supply Agreement
This agreement is described below under the section entitled
Cornerstones Business License and
Collaboration Agreements Meiji
SPECTRACEF License and Supply Agreement beginning on
page 211 of this proxy statement/prospectus.
Patheon
SPECTRACEF Finished Product Orders
From time to time Cornerstone engages Patheon to manufacture
SPECTRACEF 200mg. The parties have not entered into a long term
manufacturing agreement. Instead, Cornerstone orders quantities
of SPECTRACEF from time to time on a purchase order basis. The
terms and conditions of such purchase orders are specified at
the time of purchase and generally include, but are not limited
to, the type and specifications of the product, the quantity,
the price, payment terms, indemnity terms and a time and place
of delivery.
Vintage
Manufacturing Agreement for APAP 325 and APAP 500
Overview
In July 2004, Cornerstone entered into a manufacturing agreement
with Vintage at the same time Cornerstone entered into an asset
purchase agreement pursuant to which Cornerstone acquired rights
to APAP 325 and APAP 500. Pursuant to the manufacturing
agreement, Vintage is obligated to manufacture BALACET 325
products, APAP 325 products and APAP 500 products in quantities
ordered by Cornerstone.
208
Fees
Under this agreement, Cornerstone is obligated to pay Vintage
for the units delivered to Cornerstone pursuant to purchase
orders delivered to Vintage.
Exclusivity
Pursuant to the manufacturing agreement, Vintage granted
Cornerstone the exclusive right to manufacture the products
named in the agreement and not to subcontract or make any other
agreements concerning the products. Also, during the term of the
agreement, Vintage agreed to exclusively supply Cornerstone, and
Cornerstone agreed to not to enter into any agreement with any
other person for the manufacture of the products.
Indemnification
Vintage agreed to indemnify Cornerstone against any loss
resulting from any breach of the agreement by Vintage or any
negligence in the manufacture of the products. Cornerstone
agreed to indemnify Vintage against any loss resulting from any
third party claims made against Vintage which arise from
Cornerstones formulation, handling, distribution or sale
of the products. In addition, the parties will indemnify each
other in connection with the challenges to certain intellectual
property rights under such partys control.
Term and
Termination
The term of the agreement expires June 2009 and will be
automatically renewed for successive one-year terms unless
either party provides written notice of termination at least one
year prior to the end of the then current term. The Agreement
contains customary provisions permitting termination based upon
breach of the agreement.
Intellectual
Property
Cornerstones success depends in part on its ability to
obtain and maintain proprietary protection for its product
candidates, technology and know-how, to operate without
infringing on the proprietary rights of others and to prevent
others from infringing its proprietary rights.
Cornerstones policy is to seek to protect its proprietary
position by, among other methods, filing U.S. and foreign
patent applications related to its proprietary technology,
inventions and improvements that are important to the
development of its business and obtaining, where possible,
assignment of invention agreements from employees and
consultants. Cornerstone also relies on trade secrets, know-how,
continuing technological innovation and in-licensing
opportunities to develop and maintain its proprietary position.
Patents
As of September 15, 2008, Cornerstone owned or exclusively
licensed a total of four issued U.S. patents and three
pending U.S. patent applications. Cornerstones patent
portfolio, which is set forth in the following table, includes
patents and patent applications with claims directed to
composition of matter, formulations of its products and product
candidates and methods of use of its products and product
candidates to treat particular indications.
209
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
|
|
|
Issued Patents
|
|
Product
|
|
Ownership
|
|
Filed
|
|
Issued
|
|
Expiration
|
|
|
4,839,350
|
|
|
Cephalosporin compounds and the production thereof
|
|
SPECTRACEF
|
|
Licensed
|
|
04/07/1987
|
|
6/13/1989
|
|
04/07/2009
|
|
5,958,915
|
|
|
Antibacterial composition for oral administration
|
|
SPECTRACEF
|
|
Licensed
|
|
10/14/1996
|
|
09/28/1999
|
|
10/14/2016
|
|
6,270,796
|
|
|
Antihistamine/
decongestant regimens for treating rhinitis
|
|
ALLERX Dose Pack(1)
|
|
Licensed
|
|
10/29/1997
|
|
08/07/2001
|
|
10/29/2017
|
|
6,843,372
|
|
|
Antihistamine/
decongestant regimens for treating rhinitis
|
|
ALLERX Dose Pack PE, ALLERX 10 Dose Pack, ALLERX 30 Dose Pack
|
|
Licensed
|
|
05/04/2001
|
|
01/18/2005
|
|
05/04/2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
|
|
|
Pending Patents
|
|
Product
|
|
Ownership
|
|
Filed
|
|
Published
|
|
Expiration
|
|
|
20040115272
|
|
|
Amorphous cefditoren pivoxil composition and process for
producing the same
|
|
SPECTRACEF
|
|
Licensed
|
|
04/26/2002
|
|
06/17/2004
|
|
04/26/2022
|
|
20080015241
|
|
|
All day rhinitic condition treatment regimen
|
|
ALLERX Dose Pack DF
|
|
Owned
|
|
07/13/2006
|
|
01/17/2008
|
|
07/13/2026
|
|
20080185313
|
|
|
Medicament regimen for treating bronchitis or lower respiratory
tract condition
|
|
None
|
|
Owned
|
|
02/05/2007
|
|
08/07/2008
|
|
02/05/2027
|
|
|
|
(1) |
|
AlleRx Dose Pack was reformulated in March 2008 and is currently
marketed under Patent No. 6,843,372 |
All patents were filed with and subsequently issued or published
by the United States Patent and Trademark Office
Other than SPECTRACEF, patent protection is not available for
composition of matter claims directed to the active
pharmaceutical ingredients of Cornerstones current
products and product candidates. As a result, Cornerstone
primarily relies on the protections afforded by its formulation
and method of use patents. Method of use patents, in particular,
are more difficult to enforce than composition of matter patents
because of the risk of off-label sale or use of the subject
compounds.
For information about the patents and patent applications that
Cornerstone owns or exclusively licenses that it considers to be
most important to the protection of its products and product
candidates, see Proprietary Rights under
each of the products and product candidates described above
under Marketed Products and Product
Development Pipeline.
210
Trade
Secrets
Cornerstone may rely, in some circumstances, on trade secrets to
protect its technology. However, trade secrets can be difficult
to protect. Cornerstone seeks to protect its proprietary
technology and processes, in part, by confidentiality agreements
with its employees, scientific advisors and consultants.
Cornerstone also seeks to preserve the integrity and
confidentiality of its data and trade secrets by maintaining
physical security of its premises and physical and electronic
security of its information technology systems. While
Cornerstone has confidence in these individuals, organizations
and systems, agreements or security measures may be breached,
and Cornerstone may not have adequate remedies for any such
breach. In addition, Cornerstones trade secrets may
otherwise become known or be independently discovered by
competitors. To the extent that Cornerstones consultants,
contractors or collaborators use intellectual property owned by
others in their work for Cornerstone, disputes may arise as to
the rights in related or resulting know-how or inventions.
Trademarks
Cornerstone uses trademarks on all of its marketed branded
products and believes that having distinctive marks is an
important factor in marketing these products. Cornerstone has
registered with the United States Patent and Trademark Office
its ALLERX, DECONSAL and BALACET trademarks, among others.
SPECTRACEF is owned by Meiji and licensed to Cornerstone for
sales and marketing purposes in the United States.
License
and Collaboration Agreements
Meiji
SPECTRACEF License and Supply Agreement
Overview
On October 12, 2006, Cornerstone entered into a license and
supply agreement, as subsequently amended, with Meiji that
grants Cornerstone an exclusive, nonassignable U.S. license
to manufacture and sell SPECTRACEF, using cefditoren pivoxil
supplied by Meiji, for its currently approved therapeutic
indications and to use Meijis SPECTRACEF trademark in
connection with the sale and promotion of SPECTRACEF for its
currently approved therapeutic indications. The agreement also
extends these rights to additional products and additional
therapeutic indications of products containing cefditoren
pivoxil supplied by Meiji that are jointly developed by Meiji
and Cornerstone and which Meiji and Cornerstone agree to have
covered by the agreement.
Fees,
Milestones and Royalties
In consideration for the licenses Meiji granted to Cornerstone,
Cornerstone agreed to pay Meiji a nonrefundable license fee of
$6 million in six installments over a period of five years
from the date of the agreement. If a generic cefditoren product
is launched in the United States prior to October 12, 2011,
Cornerstone will be released from its obligation to make any
further license fee payments due after the date of launch,
unless, as agreed in a July 27, 2007 letter agreement
between Cornerstone and Meiji, Cornerstone successfully launches
SPECTRACEF 400 mg, SPECTRACEF Once Daily or SPECTRACEF
Suspension and sales of these products substantially lessen the
generic products adverse effect on SPECTRACEF sales. If
Cornerstone is able to launch one of these SPECTRACEF line
extensions and substantially mitigate the effect of generic
competition, it will be required to continue paying Meiji a
reasonable amount of the license fee as mutually agreed by the
parties.
The license and supply agreement also requires Cornerstone to
make quarterly royalty payments based on the net sales of the
cefditoren pivoxil products covered by the agreement.
Cornerstone is required to make these payments for a period of
ten years from the date the particular product is launched by
Cornerstone.
Exclusive
Supplier and Minimum Purchase Obligation
Under the license and supply agreement, Meiji is
Cornerstones exclusive supplier of cefditoren pivoxil.
Pursuant to the current draft of the written addendum to the
license and supply agreement, which is expected
211
to become effective in October 2008, Cornerstone will be
obligated to make aggregate combined purchases of API,
SPECTRACEF 200 mg, SPECTRACEF 400 mg and sample packs
of SPECTRACEF 400 mg from Meiji exceeding specified dollar
amounts annually over a five year period. These purchase
obligations are described in the section entitled
Cornerstones Business License and
Collaboration Agreements Meiji Addendum
to License and Supply Agreement beginning on page 213
of this proxy statement/prospectus. If Cornerstone does not meet
its minimum purchase requirement in a given year, Cornerstone
must pay Meiji an amount equal to 50% of the shortfall in that
year. These minimum purchase requirements cease to apply if a
generic cefditoren product is launched in the United States
prior to October 12, 2011.
Indemnification
Pursuant to the license and supply agreement, Meiji agrees to
indemnify Cornerstone against any actions arising out of a
breach of the agreement or any actions by third parties due to a
defect in the API if such defect is attributable to Meiji in the
manufacture of the API. Cornerstone agrees to indemnify Meiji
against any actions arising out of a breach of the agreement or
any actions by third parties resulting from the use of the API
and manufacture, use, marketing, distribution or sale of
SPECTRACEF. Notwithstanding the above, if any third party claims
that SPECTRACEF caused adverse reactions despite the product
being in strict compliance with specifications that were
approved by the FDA and applicable cGMP and was not misbranded
or otherwise altered, Cornerstone is not obligated to indemnify
Meiji and Cornerstone has the right to deduct 50% of any costs
incurred in connection with such claims from the license fee and
royalty otherwise payable to Meiji.
Term and
Termination
The term of the license and supply agreement is described in the
section entitled Cornerstones Business
License and Collaboration Agreements
Meiji Addendum to License and Supply Agreement
beginning on page 213. In addition to customary provisions
permitting termination based upon bankruptcy protection,
insolvency and breach of the agreement, Meiji may immediately
terminate the agreement if Cornerstone undergoes a change in
control as defined in the agreement without Meijis
consent, which may not be unreasonably withheld; ceases selling
SPECTRACEF for a period of 60 days, unless the cessation is
due to a force majeure event or a failure or delay by Meiji in
supplying cefditoren pivoxil; or promotes, markets or sells,
either directly or indirectly through a third party, any
pharmaceutical products in the United States of the same
therapeutic class as cefditoren pivoxil. On or after
April 1, 2012, Cornerstone may terminate the agreement with
270 days prior written notice if a generic cefditoren
product is launched in the United States that substantially
lessens Cornerstones sales of SPECTRACEF. If the agreement
is terminated by Cornerstone based upon Meijis bankruptcy,
insolvency or breach of the agreement, or by Meiji based upon
Cornerstone undergoing a change of control, then Cornerstone has
the right to continue selling the product from its existing
inventory and to manufacture and sell additional product using
its existing inventory of API, in each case for a period of 180
days after such termination.
Joint
Product Development
If either Meiji or Cornerstone desires to develop new products
or new therapeutic indications of an existing product under the
license and supply agreement, that party must notify the other
party, and both parties must then discuss in good faith the
joint development of the new product or therapeutic indication
and agree on whether the license and supply agreement will cover
the new product or therapeutic indication.
Meiji
Letter Agreement and Formulation Agreement
On July 27, 2007, Meiji and Cornerstone entered into a
letter agreement whereby they agreed that the terms and
conditions of the license and supply agreement apply to
SPECTRACEF 400 mg, SPECTRACEF Suspension and SPECTRACEF
Once Daily once Cornerstone receives the necessary FDA approvals
for these SPECTRACEF line extensions, provided that there is a
reduction to the royalty paid by Cornerstone to Meiji to
compensate for the development expenses. The letter agreement
requires Cornerstone to bear all of the development costs for
SPECTRACEF 400 mg. The letter agreement further provides
that Cornerstone has the
212
exclusive right to manufacture and sell these SPECTRACEF line
extensions in the United States for their approved therapeutic
indications and to use the SPECTRACEF trademark in connection
with the sale of these SPECTRACEF line extensions for their
approved therapeutic indications. The parties agreed to add a
production site for the manufacture of SPECTRACEF 200 mg
tablets and Meiji would pay Cornerstone a reimbursement fee for
expenses to be incurred by Cornerstone for regulatory work and
filings in connection with adding the production site.
Under a further letter agreement dated January 11, 2008, or
the formulation agreement, Cornerstone and Meiji agreed on the
allocation of expenses related to the development of SPECTRACEF
Suspension and SPECTRACEF Once Daily, and Meiji made payments
for the development of these product candidates to Cornerstone
in installments through June 30, 2008.
Meiji
Joint Development Agreement
On February 11, 2008, Cornerstone and Meiji entered into a
joint development agreement, which supplemented the
July 27, 2007 letter agreement and the January 11,
2008 formulation agreement. Under the joint development
agreement, Meiji granted Cornerstone the exclusive right to
develop SPECTRACEF Suspension and SPECTRACEF Once Daily in the
United States. Under the joint development agreement, Meiji and
Cornerstone agreed on a development plan for SPECTRACEF
Suspension and SPECTRACEF Once Daily; agreed that Cornerstone
would bear all expenses related to the development of these
SPECTRACEF line extensions except as provided in the formulation
agreement; and confirmed that, once approved, the terms and
conditions of the license and supply agreement apply to the
SPECTRACEF line extensions, unless otherwise provided in the
joint development agreement.
Term and
Termination
The term of the joint development agreement runs concurrently
with the term of the license and supply agreement, unless
earlier terminated. In addition to customary provisions
permitting termination based upon bankruptcy protection,
insolvency and breach of the agreement, either party may
terminate the agreement after consultation with the other party
and with 30 days prior written notice, if it becomes
impossible or impracticable from a reasonable pharmaceutical
point of view to continue the development of SPECTRACEF
Suspension and SPECTRACEF Once Daily. If Cornerstone terminates
the joint development agreement based on impossibility or
impracticability from a reasonable pharmaceutical point of view,
Cornerstones rights to SPECTRACEF Suspension and
SPECTRACEF Once Daily under the July 27, 2007 letter
agreement and the joint development agreement will terminate,
and Cornerstone would be required to assist Meiji with further
development of those product candidates if so requested by Meiji.
Meiji
Addendum to License and Supply Agreement
Overview
In August 2008, Cornerstone and Meiji entered into a verbal
agreement to expand the scope of the license and supply
agreement. The parties are currently negotiating a written
addendum to the license and supply agreement, which Cornerstone
expects will supersede the verbal agreement in
October 2008. Cornerstone believes the negotiations to be
substantially complete and that the material terms of such
written addendum will be as described below. Meiji has begun
manufacturing SPECTRACEF 400 mg pursuant to the verbal
agreement pending the parties execution of the written
addendum.
Under the latest draft of the written addendum, Meiji will grant
Cornerstone an exclusive right to sell SPECTRACEF 200 mg
and SPECTRACEF 400 mg in the United States. The terms and
conditions of the license and supply agreement continue to
remain in full force and effect, except to the extent expressly
varied or amended by the written addendum.
213
Fees and
Royalty Payments
Cornerstone does not expect to have to pay any additional
license fees for the additional licenses; however, the latest
draft of the written addendum requires Cornerstone to make
quarterly royalty payments based on the net sales covered by the
addendum for a period of 10 years from the launch date for
each product.
Exclusivity
and Minimum Purchase Requirements
Under the latest draft of the written addendum, Meiji will be
Cornerstones exclusive supplier of SPECTRACEF 400 mg
during the
10-year
period so long as Meiji is able to supply 100% of
Cornerstones requirements for this product. Additionally,
Meiji will be a non-exclusive supplier of SPECTRACEF 200 mg
during the 10-year period. Cornerstone is required to purchase
from Meiji combined amounts of API, SPECTRACEF 200 mg,
SPECTRACEF 400 mg and sample packs of SPECTRACEF
400 mg exceeding $15.0 million for the first year
beginning with the commercial launch of SPECTRACEF 200 mg
or SPECTRACEF 400 mg manufactured by Meiji, whichever is
earlier, $20.0 million for year two, $25.0 million for
year three, $30.0 million for year four and
$35.0 million for year five. If Cornerstone does not meet
its minimum purchase requirement in a given year, Cornerstone
must pay Meiji an amount equal to 50% of the shortfall in that
year. Cornerstone expects to exceed the minimum purchase
requirements. If Cornerstone is unable to meet the minimum
purchase requirements, the parties agree to discuss in good
faith measures they can take to address the situation. If
Cornerstone launches the Once-Daily product, then the parties
will discuss in good faith if any adjustments are required to
the minimum purchase requirements.
Indemnification
Under the latest draft of the written addendum, Meiji agrees to
indemnify Cornerstone against any actions arising out of a
breach of the agreement or any actions by third parties due to a
defect in the SPECTRACEF 200 mg and SPECTRACEF 400 mg
if such defect is attributable to Meiji in the manufacture,
storage, handling or shipment of SPECTRACEF 200 mg and
SPECTRACEF 400 mg. Cornerstone agrees to indemnify Meiji
against any actions arising out of a breach of the agreement or
any actions by third parties resulting from the use of
SPECTRACEF 200 mg and SPECTRACEF 400 mg and
manufacture, use, marketing, distribution or sale of the
product. Notwithstanding the above, if any third party claims
that the product caused adverse reactions despite the product
being in strict compliance with specifications that were
approved by the FDA and applicable cGMP and was not misbranded
or otherwise altered, and there is no negligence or willful
misconduct by Cornerstone in marketing and selling SPECTRACEF
200 mg and SPECTRACEF 400 mg, Cornerstone is not
obligated to indemnify Meiji and Cornerstone has the right to
deduct 50% of any costs incurred in connection with such claims
from the royalty otherwise payable to Meiji.
Term
The term of the license and supply agreement, as amended by the
latest draft of the written addendum, continues on a
product-by-product
basis until the expiration of 10 years from the launching
date of each product. In addition, the term, on a
product-by-product
basis, shall automatically renew for subsequent one-year periods
unless either party gives the other party six months prior
written notice of its intention not to renew.
Pharmaceutical
Innovations ALLERX 372 Patent License
Agreement
Overview
On August 31, 2006, Cornerstone entered into a license
agreement with Pharmaceutical Innovations that, as subsequently
amended, provides for an exclusive license in the United States
and Puerto Rico and a nonexclusive license in all other markets
to manufacture, package, market, distribute and otherwise
exploit ALLERX Dose Pack products that are covered by claims
under the 372 Patent, by corresponding foreign patents and
foreign patent applications and by certain Pharmaceutical
Innovations know-how related to those ALLERX Dose Pack products.
Cornerstone also has the right to sublicense its rights under
the license agreement to third parties. The 372 Patent
expires May 4, 2021. On June 13, 2008, the
U.S. Patent and
214
Trademark Office received a request from Vision to re-examine
the 372 Patent. On August 21, 2008, the
U.S. Patent and Trademark Office ordered the re-examination
of the 372 Patent. These re-examination proceedings are
more fully discussed in the section entitled
Cornerstones Business Legal
Proceedings beginning on page 232 of this proxy
statement/prospectus.
Royalties
Cornerstone pays Pharmaceutical Innovations royalties based on
net sales per calendar year of each product covered by the
licensed Pharmaceutical Innovations patents or know-how.
Cornerstone has agreed to a minimum annual royalty payment to
Pharmaceutical Innovations throughout the term of the agreement.
Royalties are payable with respect to the licensed patents until
the earlier of the date all of the licensed patents expire or
the date all of the licensed patents are determined to be
invalid by a court or other governmental authority and such
determination is no longer subject to appeal. Royalties are
payable with respect to licensed know-how for a further period
of seven years after the expiration of Cornerstones
obligation to pay royalties with respect to the licensed patents.
Infringement
by Third Parties and Indemnification
Pharmaceutical Innovations is obligated to pay all costs and
expenses for any action prosecuted by Pharmaceutical Innovations
related to third party infringement of any of Pharmaceutical
Innovations patents. If Pharmaceutical Innovations elects
not to prosecute such an action, Cornerstone is allowed to do so
at its sole option.
Each party is obligated to indemnify the other party from all
claims arising out of any claim that the technology of the other
party infringes any intellectual property of a third party. The
party indemnifying the other party is permitted to control the
defense of such action.
Term and
Termination
The term of the agreement expires on the seventh anniversary of
the earlier of the date that all the licensed patents expire or
the date all licensed patents are determined to be invalid by a
court or other governmental authority and such determination is
no longer subject to appeal. The agreement contains customary
provisions permitting termination based upon bankruptcy,
insolvency and breach of the agreement. Following expiration of
the agreement, Cornerstone has a fully paid, perpetual license
to continue to make use of the Pharmaceutical Innovations
know-how to manufacture, package, market, distribute and
otherwise exploit the ALLERX Dose Pack products covered by
claims under the 372 Patent.
Neos
Development, License and Services Agreement
Methscopolamine/Antihistamine Product
Overview
In March 2008, Cornerstone entered into a development, license
and service agreement with Neos pursuant to which Cornerstone
obtained an exclusive license under Neoss patent-pending
Dynamic Variable Release technology to develop, manufacture and
commercialize a combination methscopolamine and antihistamine
product in the United States, subject to obtaining necessary
approvals from the FDA. Under the agreement, Neos is responsible
for formulation of the licensed product, development and
documentation of the manufacturing process for such product, and
preparation of the chemistry, manufacturing and controls section
of the NDA for such product. Following successful formulation,
Neos is responsible for manufacturing the licensed product for
use in connection with Cornerstones clinical trials and
Cornerstones submission of an NDA to the FDA for the
licensed product. Neos also has the exclusive right to
manufacture the licensed product for commercial sale following
FDA approval pursuant to a separate supply agreement that the
parties would enter into following FDA approval of the licensed
product.
215
Fees,
Milestones and Royalties
Under the agreement, Cornerstone is obligated to pay Neos a
minimum fee of approximately $1.8 million for its
performance of the development work under the agreement, plus
hourly fees related to development work performed by Neos
personnel as reflected in a mutually agreed development plan or
otherwise approved by Cornerstone.
In consideration for Neoss exclusive license of
patent-pending Dynamic Variable Release technology and related
know-how in connection with the methscopolamine and
antihistamine combination product, CPB 058, Cornerstone is
obligated to pay royalties determined as a percentage of net
sales of any licensed product.
Exclusivity
Until the earlier of the fifth anniversary of the initial NDA
submission, the expiration of the agreement or the expiration of
the supply agreement, Neos agreed not to utilize the
manufacturing site, perform any services or permit any use of
intellectual property for the benefit of a third party in
connection with development, manufacture or commercialization of
any combination of pharmaceutical product for human use in the
United States containing the methscopolamine and antihistamine
API being developed for Cornerstone without Cornerstones
prior written consent. In addition, Neos has the exclusive right
to manufacture the product for commercial sale following FDA
approval pursuant to a separate supply agreement that the
parties agree to negotiate in good faith.
Indemnification
Under the agreement, Neos is obligated to indemnify Cornerstone
against all losses incurred in connection with third party
claims arising out of Neoss breach of the agreement, the
manufacture, delivery, storage, handling and use of the product,
any infringement claim concerning intellectual property, or any
negligence, recklessness or willful misconduct of Neos, provided
that Neos will not indemnify for losses due to
Cornerstones negligence, recklessness or willful
misconduct or Cornerstones breach of the agreement.
Cornerstone is obligated to indemnify Neos against all losses
incurred in connection with third party claims arising out of
Cornerstones breach of the agreement, or any negligence,
recklessness or willful misconduct of Cornerstone, provided that
Cornerstone will not indemnify for losses due to Neoss
negligence, recklessness or willful misconduct or
Cornerstones breach of the agreement.
Term and
Termination
The agreement expires on the earlier of March 19, 2013 or
FDA approval of the NDA for the licensed product. In addition to
customary provisions permitting termination based upon
bankruptcy protection, insolvency and breach of the agreement,
Cornerstone may terminate the agreement with 90 days
prior written notice if Neos fails to meet any milestones or
quality targets determined in the development plan and may
terminate the agreement immediately if Neoss manufacturing
site is revoked as a cGMP manufacturing facility by the FDA.
Cornerstone also may immediately terminate the agreement if the
product is unable to achieve a suitable pharmacokinetic profile
as determined by the bioavailability study in the development
plan or if Cornerstone receives a complete response letter from
the FDA with respect to the licensed product. Either party may
terminate the agreement upon 30 days notice if the other
party cannot perform its obligations for any reason for
90 days.
If the NDA is approved by the FDA, Neoss license of its
Dynamic Variable Release technology and related know-how to
Cornerstone and Neoss exclusive manufacturing rights with
respect to any licensed product will continue in full force and
effect despite the expiration of the agreement generally.
Additionally, Cornerstones obligation to pay royalties
with respect to any licensed product will continue until
March 19, 2013 if no U.S. patent with a valid claim
covering the licensed product has been issued or, if later, such
date as there no longer exists a valid claim covering the
licensed product under an issued U.S. patent or patent
application.
216
Neos
and Coating Place Development and Manufacturing
Agreement Hydrocodone Cough Suppressant
Products
Overview
In February 2008, Cornerstone entered into a development and
manufacturing agreement with Neos and Coating Place, Inc.,
pursuant to which Cornerstone obtained an exclusive license
under Neoss patent-pending Dynamic Variable Release
technology and Dynamic Time Release Suspension technology and
Coating Places patent-pending drug resin complex
technology to develop, manufacture and commercialize
extended-release antihistamine and antitussive combination
products to compete directly in the U.S. hydrocodone cough
suppressant market, subject to obtaining necessary approvals
from the FDA. Cornerstone is obligated to use commercially
reasonable efforts to develop and launch the licensed products
as soon as practicable and thereafter to maximize sales of the
licensed products in the United States.
Fees,
Milestones and Profit Sharing
In consideration for its rights under the agreement, Cornerstone
paid Neos and Coating Place aggregate upfront fees of $500,000,
and following product launch, Cornerstone, Neos and Coating
Place will share the net profits from sales of the licensed
products equally.
Product
Development, Regulatory and Commercialization Expenses
Under the agreement, Cornerstone is obligated to reimburse Neos
and Coating Place for their respective costs of performing the
development work related to the licensed products. Prior to
product launch, Cornerstone is responsible for all expenses
incurred for regulatory filings with the FDA except the parties
have agreed to share equally the PDUFA fees for licensed
products. Following product launch, Cornerstones expenses
of maintaining the FDA drug approval and its selling, marketing
and distribution expenses will be deducted from gross profits
from the sale of licensed products prior to the division of net
profits among the parties.
Exclusivity
Under the agreement, Coating Place has the exclusive right to
supply Neos with the drug resin complex needed to manufacture
the licensed products. Neos is responsible for formulation
development related to the licensed products and has the
exclusive right to manufacture the licensed products for
commercial sale. Cornerstone is responsible for all regulatory
activities with respect to licensed products in the United
States including preparation and submission of a new drug
application and, following FDA approval has the exclusive right
to sell, market and distribute the licensed products.
Indemnification
Under the agreement, Cornerstone is obligated to indemnify Neos
and Coating Place against actions arising out of any breach of
the agreement by Cornerstone and the sale, distribution or
marketing of the product. Neos is obligated to indemnify
Cornerstone and Coating Place against actions arising out of any
breach of the agreement by Neos. Coating Place is obligated to
indemnify Cornerstone and Coating Place against actions arising
out of any breach of the agreement by Coating Place. The
indemnification obligations contained in the agreement do not
extend to any loss which is the direct result of negligence,
intentional misconduct of the party seeking indemnification or
any matter for which the party seeking indemnification is
obligated to provide indemnification to the other party.
Term and
Termination
The term of this agreement is 15 years from the date the
first product is approved by the FDA, with the opportunity for
one or more additional five-year successive terms, as mutually
agreed by the parties.
The Agreement contains customary provisions permitting
termination based upon bankruptcy, insolvency and breach of the
agreement. Additionally, if Cornerstone has failed to
commercially launch the first product in the United States or
Canada by the fifth anniversary of the agreement, any party may
immediately terminate the
217
agreement by written notice to the other parties. Additionally,
upon the failure of clinical testing with respect to Neoss
proposed formulation for the first product or Cornerstones
receipt of an FDA rejection of Cornerstones drug approval
application with respect to the first product, if Cornerstone
decides not to proceed with additional work or studies, then
Cornerstone has the right to immediately terminate the agreement
by written notice to the other parties.
Neos
Products Development Agreement
Overview
In August 2008, Cornerstone entered into a products development
agreement with Neos, which amended and restated an earlier
agreement Cornerstone and Neos had entered into in December
2006, pursuant to which Cornerstone engaged Neos to develop
extended-release liquid products to be sold by doctors
prescription only using Neoss patent-pending Dynamic Time
Release Suspension technology, of the following types: an
antinauseant/antitussive combination, an
antihistamine/antitussive combination, an
antihistamine/decongestant combination and an antitussive
combination. Under the agreement, Neos is responsible for
formulation of each licensed product, development and
documentation of the manufacturing process for such product, and
preparation of the chemistry, manufacturing and controls section
of the NDA or other regulatory submission for such product.
Following successful formulation, Neos is responsible for
manufacturing the licensed product for use in connection with
Cornerstones clinical trials and Cornerstones
submission of an NDA or other regulatory submission to the FDA
for the licensed product. Neos also has the exclusive right to
manufacture the licensed product for commercial sale following
FDA approval pursuant to a separate manufacturing agreement that
the parties would enter into following FDA approval of the
licensed product.
Fees,
Milestones and Royalties
Under the agreement, Cornerstone forgave debt owed by Neos
totaling $500,000. Neos, at it own expense, is obligated to
develop the first product up to and including completion of the
first clinical study in humans. Cornerstone is obligated to pay
Neos hourly fees related to development work performed by Neos
personnel as reflected in a mutually agreed development plan or
otherwise approved by Cornerstone. In addition, Cornerstone is
obligated to pay certain milestone payments for additional work
by Neos, including work performed in connection with regulatory
approval and patent issuance. In connection with a manufacturing
agreement, Cornerstone will be obligated to pay royalties
determined as a percentage of net sales of any licensed product.
Exclusivity
During the term, each party has agreed that it will work
exclusively with the other party in developing (or attempting to
develop) the products for sale in the United States in
accordance with the terms of the agreement.
Indemnification
Cornerstone is obligated to indemnify and hold Neos harmless
from any actions arising out of a third party claim resulting
from any breach by Cornerstone of any term contained in the
agreement, or the willful infringement by Cornerstone of a third
partys intellectual property rights related to the
products. Neos is obligated to indemnify and hold Cornerstone
harmless from any actions arising out of any breach by Neos of
any term contained in the agreement or the willful infringement
of any patent or misappropriation of any trade secret by Neos in
connection with the agreement or the performance of Neoss
obligations except to the extent arising out of the willful
infringement by Cornerstone of a third partys patent
rights or misappropriation of any trade secret.
Term and
Termination
The agreement expires on December 31, 2026. In addition to
customary provisions permitting termination based upon
bankruptcy protection, insolvency and breach of the agreement,
this agreement may be terminated
218
upon written notice by either party to the other that federal or
state regulatory authorities with jurisdiction over a party and
the products has effected, or will effect at a time certain,
changes to the regulations or have instituted one or more
enforcement actions that can, in the determination of the
relevant party, be reasonably expected to result in the
commercial infeasibility of the objectives of the agreement. The
agreement may also be terminated upon written notice by
Cornerstone to Neos if Cornerstone determines that continued
investment in the development or commercialization of the
products is not commercially advisable.
Sovereign
Supply and Marketing Agreement for Sovereigns Hyoscyamine
Products
Overview
In May 2008, Cornerstone, through its wholly owned subsidiary
Aristos, entered into a supply and marketing agreement with
Sovereign pursuant to which Cornerstone obtained the exclusive
right to market, sell and distribute in the United States three
of Sovereigns generic products, each containing the API
hyoscyamine.
Profit
Share
Under this agreement, Cornerstone is obligated to use
commercially reasonable efforts to market, sell and distribute
each of the three hyoscyamine products manufactured by Sovereign
to wholesalers and distributors in the United States in return
for a share of the net profits realized from the sale of the
products.
Indemnification
Pursuant to the agreement, Sovereign agreed to indemnify
Cornerstone against any losses arising from any action by a
third party to the extent such losses arise from a material
breach of the agreement, however, Sovereign is not obligated to
indemnify Cornerstone to the extent such losses arise from the
gross negligence or willful misconduct of Cornerstone or a
material breach by Cornerstone. Cornerstone agreed to indemnify
Sovereign against any losses arising from any action by a third
party to the extent such losses arise from a material breach of
the agreement, however, Cornerstone is not obligated to
indemnify Sovereign to the extent such losses arise from the
gross negligence or willful misconduct of Sovereign or a
material breach by Sovereign.
Term and
Termination
The initial term of the agreement expires April 30, 2011
and will be automatically renewed for successive one-year terms
unless either party provides written notice of termination. The
Agreement contains customary provisions permitting termination
based upon bankruptcy, insolvency and breach of the agreement.
Cornerstone also may immediately terminate the agreement by
written notice if Sovereign undergoes a change of control as
defined in the agreement or if the FDA or other regulatory
authority orders the discontinuance for any reason of the
commercial sale of the products. Notwithstanding the expiration
or termination of the Agreement, Cornerstone may continue to
sell all hyoscyamine products in its inventory until such
inventory is exhausted unless commercial sale of the products
has been discontinued pursuant to orders of the FDA or other
regulatory authority.
Capellon
Verbal Agreement for Capellons Products
Overview
Cornerstone, through its wholly owned subsidiary Aristos, is
marketing and distributing HYOMAX DT tablets in the United
States pursuant to a verbal agreement between Cornerstone and
Capellon. The parties are currently negotiating a written
license agreement and Cornerstone expects that a written
agreement will supersede the verbal agreement in
October 2008.
Cornerstone believes the negotiations to be substantially
complete and that the material terms of such written agreement
will be as described below.
219
Profit
Sharing
Under this most recent draft of the written agreement,
Cornerstone will be obligated to use commercially reasonable
efforts to market, sell and distribute the HYOMAX DT product
manufactured by Capellon to wholesalers and distributors in the
United States in return for a share of the net profits realized
from the sale of the products.
Indemnification
Pursuant to the most recent draft of the written agreement,
Capellon will agree to indemnify Cornerstone against
(i) any losses arising from any action by a third party to
the extent such losses arise from a material breach of the
agreement, however, Capellon will not be obligated to indemnify
Cornerstone to the extent such losses arise from (i) the
gross negligence or willful misconduct of Cornerstone or
(ii) a material breach by Cornerstone. Cornerstone will
agree to indemnify Capellon against (i) any losses arising
from any action by a third party to the extent such losses arise
from a material breach of the agreement, however, Cornerstone
will not be obligated to indemnify Capellon to the extent such
losses arise from (i) the gross negligence or willful
misconduct of Capellon or (ii) a material breach by
Capellon.
Term and
Termination
The proposed initial term of the most recent draft of the
written agreement will expire April 30, 2011 and will be
automatically renewed for successive one-year terms unless
either party provides written notice of termination at least
90 days prior to the end of the then current term. In
addition to customary provisions permitting termination based
upon bankruptcy protection, insolvency and breach of the
agreement, Cornerstone will be able to immediately terminate the
agreement by written notice if Sovereign undergoes a change of
control as defined in the agreement or if the FDA or other
regulatory authority orders the discontinuance for any reason of
the commercial sale of the products. Notwithstanding the
expiration or termination of the Agreement, Cornerstone may
continue to sell all HYOMAX DT product in its inventory until
such inventory is exhausted unless commercial sale of the
products has been discontinued pursuant to orders of the FDA or
other regulatory authority.
Vintage
Asset Purchase Agreement Propoxyphene/Acetaminophen
Products
Overview
In July 2004, Cornerstone entered into an asset purchase
agreement, as subsequently amended, with Vintage, pursuant to
which Cornerstone obtained the rights, title and interest to
BALACET 325 and APAP 500. Under this agreement, Cornerstone has
all rights to promotion, marketing, sale, distribution and
manufacturing of these two products. In addition, Vintage
granted Cornerstone the right to market and sell an authorized
generic version of BALACET 325. Cornerstones authorized
generic version of BALACET 325 is referred to herein as APAP 325.
Fees and
Royalties
Cornerstone paid an $8,000,000 fee in connection with the asset
purchase agreement and is obligated to pay Vintage a royalty
equal to a percentage of net sales of BALACET 325, APAP 500 and
APAP 325 each calendar quarter.
Indemnification
Pursuant to the asset purchase agreement, Vintage agreed to
indemnify Cornerstone against any actions arising out of a
breach of the agreement, the gross negligence or willful
misconduct of Vintage and liabilities related to the products
incurred prior to the closing. Cornerstone agreed to indemnify
Vintage against any actions arising out of a breach of the
agreement, the gross negligence or willful misconduct of Vintage
and Cornerstones manufacturing, storage, marketing,
promotion, sale or distribution of the products after closing.
220
Pliva
APAP 500 Supply and Marketing Agreement
In September 2005, Cornerstone entered into a supply and
marketing agreement with Pliva, granting Pliva the exclusive
right to market Cornerstones propoxyphene napsylate and
acetaminophen
100mg/500mg
product, APAP 500, in the United States and its territories.
Under this agreement, Cornerstone handles the regulatory
processes and Vintage supplies Pliva with the APAP 500 product.
Under this agreement, Pliva is obligated to pay Cornerstone a
percentage of net sales each calendar quarter through the term
of the agreement.
The current term of this agreement expires December 31,
2008. Cornerstone has given notice to Pliva that at the end of
the current term, it will terminate the agreement. At the end of
the term, Cornerstone will commence sales and marketing of this
product directly.
Competition
The pharmaceutical industry, including the respiratory market in
which Cornerstone principally competes, is characterized by
rapidly advancing technologies, intense competition and a strong
emphasis on proprietary products. Cornerstone faces potential
competition from many different sources, including commercial
pharmaceutical and biotechnology enterprises, academic
institutions, government agencies and private and public
research institutions. Cornerstones current products
compete, and any product candidates that it successfully
develops and commercializes will compete, with existing
therapies and new therapies that may become available in the
future.
Many of Cornerstones competitors may have significantly
greater financial resources and expertise in research and
development, manufacturing, conducting clinical trials,
obtaining regulatory approvals and marketing approved products
than Cornerstone does. These competitors also compete with
Cornerstone in recruiting and retaining qualified scientific and
management personnel, establishing clinical trial sites and
patient registration for clinical trials and acquiring
technologies complementary to, or necessary for,
Cornerstones programs or advantageous to its business. In
many cases, products that compete with Cornerstones
currently marketed products and product candidates have well
known brand names, are distributed by large pharmaceutical
companies with substantial resources and have achieved
widespread acceptance among physicians and patients. The
principal competitors to Cornerstones products are more
fully discussed in the section entitled Risks Related to
Cornerstone Cornerstone faces competition, which may
result in others discovering, developing or commercializing
products before or more successfully than Cornerstone
beginning on page 62 of this proxy statement/prospectus.
Smaller or early stage companies may also prove to be
significant competitors, particularly through collaborative
arrangements with large and established companies.
Cornerstones ability to remain competitive in the
marketplace is also impacted by its ability to compete
successfully with other specialty pharmaceutical companies for
product and product candidate acquisition and in-licensing
opportunities. These established companies may have a
competitive advantage over Cornerstone due to their size and
financial resources.
The key competitive factors affecting the success of all of
Cornerstones products and product candidates, if approved,
are and are likely to continue to be efficacy, safety,
convenience, price, the availability of patent protection or
regulatory marketing exclusivity, the level of generic
competition and the availability of reimbursement from
government and other third-party payors.
Cornerstones commercial opportunity could be reduced or
eliminated if its competitors develop and commercialize products
that are more effective, safer, have fewer or less severe side
effects, are more convenient or are less expensive than any
products that Cornerstone may develop. Cornerstones
competitors also may obtain FDA or other regulatory approval for
their products more rapidly than Cornerstone may obtain approval
for its products. In addition, Cornerstones ability to
compete may be affected because in some cases insurers or other
third-party payors seek to encourage the use of generic
products, which may have the effect of making branded products
less attractive, from a cost perspective, to buyers.
221
Marketed
Products
Cornerstones currently marketed products face significant
competition from a wide range of branded and generic products
for the same therapeutic indications. Upon loss of regulatory
marketing exclusivity or patent protection or as a result of
design-around strategies that allow for generic product
introduction prior to the expiration of key product patents,
Cornerstone is potentially subject to competition from generic
versions of its branded products. Generics are typically priced
at lower levels than branded products and may substantially
erode prescription demand and sales of Cornerstones
branded products. The specific competitive conditions affecting
SPECTRACEF and ALLERX are more fully discussed in the sections
entitled Marketed Products beginning on
page 192 of this proxy statement/prospectus.
Cornerstones generic products are also subject to
competition from equivalent generic products introduced by other
pharmaceutical companies. Such competition may adversely impact
the sales volume and pricing of Cornerstones generic
products and Cornerstones ability to profitably market
these products.
Product
Candidates
Given that Cornerstone is developing product candidates based on
currently marketed drug compounds, some or all of the products
in Cornerstones product pipeline, if approved, may face
competition from generic and branded formulations of these
existing drugs. Cornerstones ability to successfully
market and sell the products in its pipeline will depend on the
extent to which its newly formulated product candidates have the
benefit of patent protection or some other form of regulatory
marketing exclusivity or are meaningfully differentiated from
these existing drugs or new competitive formulations of these
drugs offered by third parties. In addition, Cornerstones
product candidates, if approved, will compete with other branded
and generic drugs approved for the same therapeutic indications,
approved drugs used off label for such indications and novel
drugs in clinical development. The competitive conditions
affecting the products in Cornerstones product pipeline is
more fully discussed in the section entitled Product
Development Pipeline beginning on page 199 of this
proxy statement/prospectus.
Regulatory
Matters
The research, testing, manufacture and marketing of drug and
biologic products are extensively regulated in the United States
and abroad. In the United States, drugs and biologics are
subject to rigorous regulation by the FDA. The FDCA and other
federal and state statutes and regulations govern, among other
things, the research, development, testing, manufacture,
storage, recordkeeping, packaging, labeling, advertising and
promotion, sampling and distribution of pharmaceutical and
biologic products. Failure to comply with applicable regulatory
requirements may subject Cornerstone to a variety of
administrative or judicially imposed sanctions, including the
FDAs refusal to accept new applications or to approve
pending applications, withdrawal of an approval, warning
letters, product recalls, product seizures, total or partial
suspension of production or distribution, injunctions, fines,
civil penalties and criminal prosecution.
United
States Approval Process for New Drug Applications
Before marketing a new drug product in the United States, the
product sponsor must first demonstrate that the product is safe,
effective and properly manufactured, and must obtain FDA
approval in the form of an approved NDA, sNDA or ANDA. As a
matter of FDA enforcement policy, limited categories of drugs
that have historically been marketed without such approval also
may remain on the market subject to the risk that the FDA may at
any time require the product sponsors to obtain approval for the
products or remove them from the market. In seeking FDA approval
for its product candidates, Cornerstone intends to follow the
development and approval pathway permitted under the FDCA that
it believes will maximize the commercial opportunities for its
product candidates.
Satisfaction of FDA approval requirements typically takes a
minimum of several years, and the actual time required may be
substantially longer depending upon the type of approval
required, the complexity of the product, the target disease or
the nature and extent of required clinical trials or other data
requirements. Compliance with FDA approval requirements will
require substantial investments of time, money and
222
corporate resources and may significantly delay or even prevent
Cornerstone from marketing potential products. Success in early
stage clinical trials does not necessarily assure success in
later stage clinical trials. Data obtained from clinical trials
are not always conclusive and may be subject to alternative
interpretations that could delay, limit or even prevent
regulatory approval. Even if a product receives regulatory
approval, later discovery of previously unknown problems with a
product may result in marketing or sales restrictions on the
product or even complete withdrawal of the product from the
market. Line extensions or other significant changes to an
approved product (e.g., adding a new dosage strength) also
require submission and prior FDA approval of a supplemental
application including additional clinical or other data required
to demonstrate the safety and efficacy of the changed product.
From time to time, legislation is drafted and introduced in
Congress that could significantly change the statutory
provisions governing the development, approval, manufacturing
and marketing of drug products. In addition, FDA regulations and
guidance are often revised or reinterpreted by the agency in
ways that may significantly affect Cornerstones business
and its products. It is impossible to predict whether
legislative changes will be enacted, or FDA regulations,
guidance or interpretations changed, or what the impact of such
changes, if any, may be.
New Drug
Application
The steps ordinarily required before a new pharmaceutical
product may be marketed in the United States include the
conduct of preclinical laboratory tests, animal tests and
formulation studies; submission to the FDA of an application for
IND, which must become effective prior to commencement of human
clinical testing; the conduct of adequate and well-controlled
clinical trials in accordance with good clinical practices to
establish that the product is safe and effective for the
indication for which FDA approval is sought; the preparation and
submission of the NDA; satisfactory completion of an FDA
inspection of the manufacturing facility or facilities at which
the product is produced to assess compliance with cGMP to assure
that the facilities, methods and controls are adequate to
preserve the drugs identity, strength, quality and purity;
and FDA review and approval of the marketing application.
Preclinical tests include laboratory evaluation of product
chemistry, toxicity and formulation, as well as animal studies
to assess the potential safety and efficacy of the product. The
conduct of the preclinical tests and formulation of compounds
for testing must comply with federal regulations and
requirements. The results of preclinical testing are submitted
to the FDA as part of an IND during the IND stage of development
and as part of the NDA.
An IND must become effective prior to the commencement of
clinical testing of a drug in humans. An IND will automatically
become effective 30 days after receipt by the FDA if the
FDA has not commented on or questioned the application during
this 30-day
waiting period. If the FDA has comments or questions, these may
need to be resolved to the satisfaction of the FDA prior to
commencement of clinical trials. In addition, the FDA may, at
any time, impose a clinical hold on ongoing clinical trials. If
the FDA imposes a clinical hold, clinical trials cannot commence
or recommence without FDA authorization and then only under
terms authorized by the FDA. The IND process can result in
substantial delay and expense.
Clinical trials involve the administration of the
investigational new drug or biologic to healthy volunteers or
patients under the supervision of a qualified investigator.
Clinical trials must be conducted in compliance with federal
regulations and requirements, under protocols detailing the
objectives of the trial, the parameters to be used in monitoring
safety and the safety and effectiveness criteria to be
evaluated. Each protocol for an unapproved drug involving
testing human subjects in the United States must be submitted to
the FDA as part of the IND. The trial protocol and informed
consent information for subjects in clinical trials must be
submitted to institutional review boards for approval.
Clinical trials to support new drug product applications for
marketing approval are typically conducted in three sequential
phases, but the phases may overlap or be combined. In
Phase I, the initial introduction of the product candidate
into healthy human subjects or patients, the product is tested
to assess metabolism; pharmacokinetics; safety, including side
effects associated with increasing doses; and, at times,
pharmacological actions. Phase II usually involves trials
in a limited patient population to determine dosage
223
tolerance and optimum dosage, identify possible adverse effects
and safety risks and provide preliminary support for the
efficacy of the product in the indication being studied.
If a compound demonstrates evidence of effectiveness and an
acceptable safety profile in Phase II evaluations,
Phase III trials are undertaken to evaluate further
clinical efficacy and to test further for safety within an
expanded patient population, typically at geographically
dispersed clinical trial sites. Phase I, Phase II or
Phase III testing of any product candidates may not be
completed successfully within any specified time period, if at
all. Furthermore, the FDA, an institutional review board or
Cornerstone may suspend or terminate clinical trials at any time
on various grounds, including a finding that the subjects or
patients are being exposed to an unacceptable health risk.
After successful completion of the required clinical testing for
a drug, generally an NDA is prepared and submitted to the FDA.
FDA approval of the NDA is required before marketing of the
product may begin in the United States. The NDA must include,
among other things, the results of all clinical and preclinical
safety testing and a compilation of the data relating to the
products pharmacology, chemistry, manufacture and
controls. The cost of preparing and submitting an NDA is
substantial. Under federal law, the submission of NDAs are
additionally subject to substantial application user fees,
currently exceeding $1.1 million, the fee for submission of
supplemental applications exceeds $580,000 and the manufacturer
and/or
sponsor under an approved NDA are also subject to annual product
and establishment user fees, currently exceeding $65,000 per
product and up to $392,000 per establishment. These fees are
typically increased annually.
In addition, under the Pediatric Research Equity Act of 2003, or
PREA, as amended and reauthorized by the FDAAA, an NDA or
supplement to an NDA must contain data that are adequate to
assess the safety and effectiveness of the drug for the claimed
indications in all relevant pediatric subpopulations, and to
support dosing and administration for each pediatric
subpopulation for which the drug is safe and effective. The
FDAAA also authorizes the FDA to require sponsors of currently
marketed drugs to conduct pediatric studies if the drug serves a
substantial number of pediatric patients and adequate pediatric
labeling could benefit such patients, the drug would provide a
meaningful therapeutic benefit for pediatric
patients or the absence of pediatric labeling could pose a risk
to pediatric patients. The FDA may, on its own initiative or at
the request of the applicant, grant deferrals for submission of
some or all pediatric data until after approval of the drug for
use in adults, or full or partial waivers from the pediatric
data requirements.
The FDA has 60 days from its receipt of an NDA to determine
whether the application will be accepted for filing based on the
agencys threshold determination that the NDA is
sufficiently complete to permit substantive review. Once the
submission is accepted for filing, the FDA begins an in-depth
review of the NDA. The review process is often significantly
extended by FDA requests for additional information or
clarification regarding information already provided in the
submission. The FDA may also refer applications for novel drug
products or drug products that present difficult questions of
safety or efficacy to an advisory committee, typically a panel
that includes clinicians and other experts, for review,
evaluation and a recommendation as to whether the application
should be approved. The FDA is not bound by the recommendation
of an advisory committee. The FDA normally also will conduct a
pre-approval inspection to ensure the manufacturing facility,
methods and controls are adequate to preserve the drugs
identity, strength, quality, purity and stability and are in
compliance with regulations governing current good manufacturing
practices. In addition, the FDA usually conducts audits of the
clinical trials for NDAs and efficacy supplements to ensure that
the data submitted reflects the data generated by the clinical
sites.
If the FDAs evaluation of the NDA submission or
manufacturing facilities is not favorable, the FDA may refuse to
approve the NDA and issue a complete response letter. The
complete response letter outlines the deficiencies in the
submission and often requires additional testing or information
in order for the FDA to reconsider the application. Even after
submitting this additional information, the FDA ultimately may
decide that the application does not satisfy the regulatory
criteria for approval. With limited exceptions, the FDA may
withhold approval of an NDA regardless of prior advice it may
have provided or commitments it may have made to the sponsor.
If the FDAs evaluations are favorable, the FDA may issue
an approval letter or, in some cases, a complete response letter
followed by an approval letter. A complete response letter
generally contains a statement that the application is not yet
ready for approval and describes the specific deficiencies and,
if applicable,
224
recommended actions an applicant might take to get the
application ready for approval. An approval letter authorizes
commercial marketing of the drug with specific prescribing
information for specific indications. As a condition of NDA
approval, the FDA may require post-approval trials and
surveillance to monitor the drugs safety or efficacy and
may impose other conditions, including labeling restrictions and
restricted distribution, which can materially impact the
potential market and profitability of the drug.
Supplemental
New Drug Application
Once an NDA is in effect, the drug sponsor must notify the FDA
of any change in an approved product beyond variations already
allowed in the marketing approval. Significant changes generally
require prior approval of an sNDA, which may require additional
clinical trials or other data required to demonstrate that the
product as modified remains safe and effective. For example,
Cornerstone submitted, and received approval for, an sNDA with
respect to SPECTRACEF 400 mg since this product represents a
change in strength from the 200 mg version of SPECTRACEF.
Other modifications which would require sNDA approval include
substantive changes in labeling, the addition of one or more new
indications for use, a new dosage form (e.g., introduction of a
new extended-release formulation), and significant manufacturing
changes including a new manufacturing site. Such supplements,
referred to as Prior Approval Supplements, must contain
information to demonstrate that the modified product will remain
safe, effective, and consistently manufactured. FDA does not
require duplication of previously-submitted data that remain
applicable to proposed NDA modification.
According to the FDAs guidelines and PDUFA agreements, the
FDA should review sNDAs within six months of submission. Once an
sNDA is submitted to the FDA the company receives from the FDA a
filing date, which is the date the FDA received and processed
the filing for documentation. This notification from the FDA to
the company usually also includes an action date which is the
date the FDA sets to indicate approval or non-approval of the
submission. An applicant may ask the FDA to expedite its review
for public health reasons, such as a drug shortage.
The process of obtaining FDA approval for an sNDA may be
expensive and time-consuming, and if not approved, the product
will not be allowed to be marketed as modified.
Abbreviated
New Drug Application
The ANDA route of approval provides for marketing of a generic
drug product that has the same active pharmaceutical ingredients
in the same strengths and dosage form as an NDA-approved
reference listed drug and has been shown through
bioequivalence testing to be therapeutically equivalent to the
listed drug. ANDA applicants are not required to conduct or
submit results of pre-clinical or clinical tests to prove the
safety or effectiveness of their drug products, other than the
requirement for bioequivalence testing. Drugs approved in this
way are commonly referred to as generic equivalents
to the listed drug, and can often be substituted by pharmacists
under prescriptions written for the original listed drug.
When a drug product is approved through an NDA, its sponsor must
list with the FDA each patent with claims that cover the product
or an approved use of the product. Upon NDA approval, the drug
product and associated patent information are published in the
FDAs Approved Drug Products with Therapeutic Equivalence
Evaluations, commonly known as the Orange Book. Drugs listed in
the Orange Book can, in turn, be cited as the reference listed
drug by subsequent ANDA applicants. The ANDA applicant must
supply information demonstrating its generic product meets the
sameness and bioequivalence requirements described
above, as well as detailed manufacturing information.
Additionally, ANDA applicants must certify to the FDA with
respect to each patent listed for the reference listed product
in the Orange Book. Specifically, the applicant must certify
that:
|
|
|
|
|
the required patent information has not been filed;
|
|
|
|
the listed patent has expired;
|
|
|
|
the listed patent has not expired, but will expire on a
particular date and approval is sought after patent
expiration; or
|
225
|
|
|
|
|
the listed patent is invalid or unenforceable or will not be
infringed by the manufacture, use or sale of the new product.
|
A certification that the new product will not infringe the
already approved products listed patents or that such
patents are invalid or unenforceable is called a
Paragraph IV certification. If the applicant does not
challenge the listed patents, the ANDA application will not be
approved until all the listed patents claiming the referenced
product have expired. If there are no listed patents, or all
patents have expired, ANDA approval will not be delayed.
If the ANDA applicant has provided a Paragraph IV
certification to the FDA, the applicant must also send notice of
the Paragraph IV certification to the NDA and patent
holders with a detailed statement of the factual and legal basis
for the applicants belief that the patents are invalid,
unenforceable or not infringed once the ANDA has been accepted
for filing by the FDA. The NDA and patent holders may then
initiate a patent infringement lawsuit in response to the notice
of the Paragraph IV certification. The filing of a patent
infringement lawsuit within 45 days of the receipt of a
Paragraph IV notice automatically prevents the FDA from
approving the ANDA for up to 30 months from the date of
receipt of notice by the patent holder. The Hatch-Waxman Act
explicitly encourages generic challenges to listed patents by
providing for a
180-day
period of generic product exclusivity for the first generic
applicant to challenge a listed patent for an NDA-approved drug.
Thus, many if not most successful new drug products are subject
to generic applications and patent challenges prior to the
expiration of all listed patents.
Section 505(b)(2)
New Drug Applications
Most drug products obtain FDA marketing approval pursuant to an
NDA or an ANDA. A third alternative is a special type of NDA,
commonly referred to as a Section 505(b)(2) NDA, which
enables the applicant to rely, in part, on the FDAs
findings of safety and efficacy of an approved product, or on
published literature, in support of its application.
Section 505(b)(2) NDAs often provide an alternate path to
FDA approval for new or improved formulations or new uses of
previously approved products, or for the initial approval of
drugs previously marketed without NDAs/ANDAs under the
Prescription Drug
Wrap-Up
program discussed below. Section 505(b)(2) permits the
submission of an NDA where at least some of the information
required for approval comes from studies not conducted by or for
the applicant and for which the applicant has not obtained a
right of reference. The applicant may rely upon the FDAs
findings with respect to particular preclinical studies or
clinical trials conducted for an approved product, or upon
published clinical and scientific data. The FDA may also require
companies to perform additional studies or measurements to
support the change from the approved product. The FDA may then
approve the new product candidate for all or some of the label
indications for which the referenced product has been approved,
as well as for any new indication sought by the
Section 505(b)(2) applicant.
To the extent that the Section 505(b)(2) applicant is
relying on studies conducted for an already approved product,
the applicant is subject to existing exclusivity for the
referenced product and is required to certify to the FDA
concerning any patents listed for the approved product in the
Orange Book to the same extent that an ANDA applicant would.
Thus, approval of a Section 505(b)(2) NDA can be stalled
until all the listed patents claiming the referenced product
have expired; until any nonpatent exclusivity, such as
exclusivity for obtaining approval of a new chemical entity
listed in the Orange Book for the referenced product, has
expired; and, in the case of a Paragraph IV certification
and subsequent patent infringement suit, until the earlier of
30 months or a decision or settlement in the infringement
case finding the patents to be invalid, unenforceable or not
infringed.
Notwithstanding the approval of many products by the FDA
pursuant to Section 505(b)(2), over the last few years,
some pharmaceutical companies and others have objected to the
FDAs interpretation of Section 505(b)(2). If the FDA
changes its interpretation of Section 505(b)(2), this could
delay or even prevent the FDA from approving any
Section 505(b)(2) NDA that Cornerstone submits.
226
Prescription
Drug
Wrap-Up
The FDCA, enacted in 1938, was the first statute requiring
premarket approval of drugs by the FDA. These approvals,
however, focused exclusively on safety data. In 1962, Congress
amended the FDCA to require that sponsors demonstrate that new
drugs are effective, as well as safe, in order to receive FDA
approval. These amendments also required the FDA to conduct a
retrospective evaluation of the effectiveness of the drug
products that the FDA approved between 1938 and 1962 on the
basis of safety alone. The agency contracted with the National
Academy of Science/National Research Council, or the NAS/NRC, to
make an initial evaluation of the effectiveness of many drug
products. The FDAs administrative implementation of the
NAS/NRC
reports was the DESI.
Drugs that were not subject to applications approved between
1938 and 1962 were not subject to DESI review. For a period of
time, the FDA permitted these drugs to remain on the market
without approval. In 1984, however, spurred by serious adverse
reactions to one of these products, Congress urged the FDA to
expand the new drug requirements to include all marketed
unapproved prescription drugs. The FDA created a program, known
as the Prescription Drug
Wrap-Up, to
address these remaining unapproved drugs. Most of these drugs
contain active pharmaceutical ingredients that were first
marketed prior to the enactment of the FDCA in 1938. Cornerstone
believes that several of its marketed pharmaceutical products
fall within this category.
The FDA asserts that all drugs subject to the Prescription Drug
Wrap-Up are
on the market illegally and are subject to FDA enforcement
action at any time. There are several narrow exceptions. For
example, both the original statutory language of the FDCA and
the 1962 amendments include grandfather provisions exempting
certain drugs from the new drug requirements. The 1938 clause
exempts drugs that were on market prior to the passage of the
FDCA in 1938 and that contain the same representations
concerning the conditions of use as they did prior to passage of
the Act. The 1962 amendments exempt, in certain circumstances,
drugs that have the same composition and labeling as they had
prior to the passage of the 1962 amendments. The FDA and the
courts have interpreted these two exceptions very narrowly. As
to drugs marketed over the counter, the FDA exempts through
regulation products that have been determined to be generally
recognized as safe and effective and have been used to a
material extent and for a material time.
The FDA has adopted a risk-based enforcement policy that
prioritizes enforcement of the new drug approval requirement for
unapproved drugs that pose a safety threat, lack evidence of
effectiveness, prevent patients from pursuing effective
therapies or are marketed fraudulently. In addition, the FDA has
indicated that approval of an NDA for one drug within a class of
drugs marketed without FDA approval may also trigger agency
enforcement of the new drug approval requirement. Once the FDA
issues an approved NDA for one of the drug products at issue or
completes the efficacy review for that drug product, it may
require other manufacturers to also file an NDA or an ANDA for
that same drug in order to continue marketing it in the United
States. While the FDA generally provides sponsors a one-year
grace period, it is not statutorily required to do so.
Post-Approval
Compliance Requirements and Changes to Approved
Products
Whatever route of approval is used to gain FDA marketing
approval, all marketed drug products are subject to certain
post-approval requirements, including requirements for adverse
event reporting and a range of periodic reporting and
recordkeeping requirements. Drug manufacturers also must comply
with the FDAs cGMP regulations, which govern all phases of
the drug production process, and manufacturing facilities are
subject to periodic FDA inspection for cGMP compliance. In
addition, the FDA strictly regulates the promotional claims that
may be made about prescription drug products and biologics. In
particular, the FDA requires substantiation of any claims of
superiority of one product over another, including that such
claims be proven by adequate and well-controlled head-to-head
clinical trials. To the extent that market acceptance of
Cornerstones products may depend on their superiority over
existing therapies, any restriction on Cornerstones
ability to advertise or otherwise promote claims of superiority,
or requirements to conduct additional expensive clinical trials
to provide proof of such claims, could negatively affect the
sales of Cornerstones products or its costs. Violation of
any FDA requirements could result in enforcement actions, such
as withdrawal of approval, product recalls, product seizures,
injunctions, total or partial suspension of
227
production or distribution, fines, consent decrees, civil
penalties and criminal prosecutions, which could have a material
adverse effect on Cornerstones business.
Cornerstone must also notify the FDA of any change in an
approved product beyond variations already allowed in the
marketing approval. Once an NDA is in effect (including a
505(b)(2) NDA), significant changes such as a change in
labeling, the addition of one or more new indications for use, a
new dosage or strength of a drug or a change in the way
Cornerstone manufactures a drug, generally require prior
approval of an sNDA, which may require additional clinical
trials or other data required to demonstrate that the product as
modified remains safe and effective. Any modification of an
ANDA-approved product that would cause the product to no longer
be identical to its listed reference product requires prior
approval in the form of a new NDA or 505(b)(2) NDA. Approvals of
labeling or manufacturing changes may be expensive and
time-consuming, and if not approved, the product will not be
allowed to be marketed as modified.
Marketing
Exclusivity and Patent Term Restoration
Under the Hatch-Waxman Act, newly approved drugs and indications
may benefit from a statutory period of non-patent marketing
exclusivity. The Hatch-Waxman Act provides five-year marketing
exclusivity to the first applicant to gain approval of an NDA
for a new chemical entity, or NCE, meaning that the FDA has not
previously approved any other drug containing the same API. The
Hatch-Waxman Act prohibits the submission of an ANDA or a
Section 505(b)(2) NDA for another version of such drug
during the five-year exclusivity period. However, submission of
an ANDA or Section 505(b)(2) NDA containing a
Paragraph IV certification is permitted after four years,
which may trigger a
30-month
stay of approval of the ANDA or Section 505(b)(2) NDA.
Although protection under the Hatch-Waxman Act will not prevent
the submission or approval of another full NDA, the
applicant would be required to conduct its own preclinical and
adequate and well-controlled clinical trials to demonstrate
safety and effectiveness. The Hatch-Waxman Act also provides
three years of marketing exclusivity for the approval of new and
supplemental NDAs, including Section 505(b)(2) NDAs, for,
among other things, new indications, dosage forms, routes of
administration, or strengths of an existing drug, or for a new
use, if new clinical investigations that were conducted or
sponsored by the applicant are determined by the FDA to be
essential to the approval of the application. Cornerstone
currently expects to seek three-year marketing exclusivity for
SPECTRACEF Once Daily. This exclusivity would not prevent the
approval of another application if the applicant has conducted
its own adequate and well controlled clinical trials
demonstrating safety and efficacy, nor would it prevent approval
of a generic product that did not incorporate the exclusivity
protected changes of the approved drug product.
Pediatric
Exclusivity
Pediatric exclusivity is another type of non-patent marketing
exclusivity in the United States and, if granted, provides for
the attachment of an additional six months of marketing
protection to the term of any existing regulatory exclusivity or
listed patent term. This six-month exclusivity may be granted
based on the voluntary completion of a pediatric study in
accordance with an FDA-issued Written Request for
such a study. Cornerstone plans to work with the FDA to
determine the need for pediatric studies for its product
candidates and may consider attempting to obtain pediatric
exclusivity for some of its product candidates.
Foreign
Regulation
Approval of a product by comparable regulatory authorities may
be necessary in foreign countries prior to the commencement of
marketing of the product in those countries, whether or not FDA
approval has been obtained. The approval procedure varies among
countries and can involve requirements for additional testing.
The time required may differ from that required for FDA
approval. Although there are some procedures for unified filings
for some European countries, such as the sponsorship of the
country which first granted marketing approval, in general each
country has its own procedures and requirements, many of which
are time consuming and expensive. Thus, there can be substantial
delays in obtaining required approvals from foreign regulatory
authorities after the relevant applications are filed.
228
Regulation
of Controlled Substances
Cornerstone sells products that are controlled
substances as defined in the Controlled Substances Act of
1970, or CSA, which establishes registration, security,
recordkeeping, reporting, labeling, packaging, storage,
distribution and other requirements administered by the DEA. The
DEA is concerned with the control of handlers of controlled
substances, and with the equipment and raw materials used in
their manufacture and packaging, in order to prevent loss and
diversion into illicit channels of commerce.
The DEA regulates controlled substances as
Schedule I, II, III, IV or V substances.
Schedule I substances by definition have no established
medicinal use, and may not be marketed or sold in the United
States. A pharmaceutical product may be listed as
Schedule II, III, IV or V, with Schedule II
substances considered to present the highest risk of abuse and
Schedule V substances the lowest relative risk of abuse
among such substances.
Annual registration is required for any facility that
manufactures, distributes, dispenses, imports or exports any
controlled substance. The registration is specific to the
particular location, activity and controlled substance schedule.
For example, separate registrations are needed for import and
manufacturing, and each registration will specify which
schedules of controlled substances are authorized.
The DEA typically inspects a facility to review its security
measures prior to issuing an initial registration. Security
requirements vary by controlled substance schedule, with the
most stringent requirements applying to Schedule I and
Schedule II substances. Required security measures include
background checks on employees and physical control of inventory
through measures such as cages, surveillance cameras and
inventory reconciliations. Records must be maintained for the
handling of all controlled substances, and periodic reports made
to the DEA, including distribution reports for Schedule I
and II controlled substances, Schedule III substances
that are narcotics and other designated substances. Reports must
also be made for thefts or significant losses of any controlled
substance, and to obtain authorization to destroy any controlled
substance. In addition, special authorization and notification
requirements apply to imports and exports.
In addition, a DEA quota system controls and limits the
availability and production of controlled substances in
Schedule I or II. Distributions of any Schedule I
or II controlled substance must also be accompanied by
special order forms, so-called DEA Form 222, with copies
provided to the DEA. Because hydrocodone and propoxyphene are
Schedule II controlled substances, they are subject to the
DEAs production and procurement quota scheme. The DEA
establishes annually aggregate quotas for how much hydrocodone
and propoxyphene may be produced in total in the United States
based on the DEAs estimate of the quantity needed to meet
legitimate scientific and medicinal needs. The limited aggregate
amounts of these substances that the DEA allows to be produced
in the United States each year are allocated among individual
companies, who must submit applications annually to the DEA for
individual production and procurement quotas. Cornerstone and
its contract manufacturers must receive an annual quota from the
DEA in order to produce or procure any Schedule I or
Schedule II substance, including propoxyphene for use in
BALACET 325, APAP 325 and APAP 500, and hydrocodone for use
in the Hydrocodone Cough Suppressants. The DEA may adjust
aggregate production quotas and individual production and
procurement quotas from time to time during the year, although
the DEA has substantial discretion in whether or not to make
such adjustments. Cornerstones, or its contract
manufacturers, quota of an API may not be sufficient to
meet commercial demand or complete clinical trials. Any delay or
refusal by the DEA in establishing Cornerstones, or its
contract manufacturers, quota for controlled substances
could delay or stop Cornerstones clinical trials or
product launches, which could have a material adverse effect on
Cornerstones business, financial position and results of
operations.
To meet its responsibilities, the DEA conducts periodic
inspections of registered establishments that handle controlled
substances. Failure to maintain compliance with applicable
requirements, particularly as manifested in loss or diversion,
can result in enforcement action that could have a material
adverse effect on Cornerstones business, results of
operations and financial condition. The DEA may seek civil
penalties, refuse to renew necessary registrations, or initiate
proceedings to revoke those registrations. In certain
circumstances, violations could result in criminal proceedings.
Individual states also regulate controlled substances, and
Cornerstone and its contract manufacturers will be subject to
state regulation on distribution of these products.
229
Hazardous
Materials
Cornerstone relies on third parties to assist it in developing
and manufacturing all of its products and does not directly
handle, store or transport hazardous materials or waste
products. The development and manufacturing activities performed
by third parties at Cornerstones request may involve the
controlled use of hazardous materials, chemicals and radioactive
materials and produce waste products. Cornerstone relies on its
third parties to comply with all applicable federal, state and
local laws and regulations governing the use, manufacture,
storage, handling and disposal of hazardous materials and waste
products. Cornerstone does not expect the cost of complying with
these laws and regulations to be material to it.
Pharmaceutical
Pricing and Reimbursement
Cornerstones ability to commercialize its products
successfully depends in significant part on the availability of
adequate coverage and reimbursement from third-party payors,
including governmental payors such as the Medicare and Medicaid
programs, MCOs, and private health insurers. Third-party payors
are increasingly challenging the prices charged for medicines
and examining their cost effectiveness, in addition to their
safety and efficacy. Cornerstone may need to conduct expensive
pharmacoeconomic studies in order to demonstrate the cost
effectiveness of its products, in addition to the costs required
to obtain FDA approvals. Even with these studies,
Cornerstones products may be considered less safe, less
effective or less cost-effective than existing products, and
third-party payors may decide not to provide coverage and
reimbursement for its product candidates, in whole or in part.
If third-party payors approve coverage and reimbursement, the
resulting payment rates may not be sufficient for Cornerstone to
sell its products at a profit.
Political, economic and regulatory influences are subjecting the
health care industry in the United States to fundamental
changes. There have been, and Cornerstone expects there will
continue to be, legislative and regulatory proposals to change
the health care system in ways that could significantly affect
Cornerstones business. Cornerstone anticipates that the
United States Congress, state legislatures and the private
sector will continue to consider and may adopt health care
policies intended to curb rising health care costs. These cost
containment measures could include, for example:
|
|
|
|
|
controls on government funded reimbursement for drugs;
|
|
|
|
controls on payments to health care providers that affect demand
for drug products;
|
|
|
|
challenges to the pricing of drugs or limits or prohibitions on
reimbursement for specific products through other means;
|
|
|
|
weakening of restrictions on imports of drugs; and
|
|
|
|
expansion of use of managed care systems in which health care
providers contract to provide comprehensive health care for a
fixed cost per person.
|
Under the Medicare Part D prescription drug benefit, which
took effect in January 2006, Medicare beneficiaries can obtain
prescription drug coverage from private plans that are permitted
to limit the number of prescription drugs that are covered on
their formularies in each therapeutic category and class. Under
this program, Cornerstones products may be excluded from
formularies and may be subject to significant price competition
that depresses the prices it is able to charge. Cornerstone
believes that it is likely that private managed care plans will
follow Medicare coverage and reimbursement policies.
Outpatient pharmaceuticals sold to state administered Medicaid
programs are subject to the national Medicaid drug rebate
program. In order to have their drugs covered by state Medicaid
programs, pharmaceutical companies must enter into an agreement
under which they agree to pay a rebate to the states which is
determined on the basis of a specified percentage of the
average manufacturer price or the difference between
the average manufacturer price and the best price.
Pharmaceutical companies must also enter into a similar
agreement with the U.S. Department of Veterans Affairs to
have their drugs covered by state Medicaid programs, and some
states may impose supplemental rebate agreements. Cornerstone is
a party to these types of pricing agreements with respect to its
currently marketed products.
230
Cornerstone may also face competition for its products from
lower-priced products from foreign countries that have placed
price controls on pharmaceutical products. Proposed federal
legislative changes may expand consumers ability to import
lower-priced versions of competing products from Canada and
other countries. In August 2007, the United States House of
Representatives passed a measure that would permit more imports
of prescription drugs, but the United States Senate has not yet
approved it. If this proposal or similar proposals become law,
Cornerstones products may be subjected to increased price
competition from lower priced imported drugs. Further, several
states and local governments have implemented importation
schemes for their citizens, and, in the absence of federal
action to curtail such activities, Cornerstone expects other
states and local governments to launch importation efforts. The
importation of foreign products that compete with
Cornerstones own products could negatively impact its
business and prospects.
Cornerstone is unable to predict what additional legislation,
regulations or policies, if any, relating to the health care
industry or third party coverage and reimbursement may be
enacted in the future or what effect such legislation,
regulations or policies would have on its business. Any cost
containment measures, including those listed above, or other
health care system reforms that are adopted could impair
Cornerstones ability to set prices that cover its costs,
constrain its ability to generate revenue from government funded
or private third party payors, limit the revenue and
profitability of its potential customers, suppliers and
collaborators and impede its access to capital needed to operate
and grow. Any of these circumstances could significantly limit
Cornerstones ability to operate profitably.
Fraud and
Abuse Regulation
A number of federal and state laws and related regulations,
loosely referred to as fraud and abuse laws, are used to
prosecute health care providers, suppliers, physicians and
others that fraudulently or wrongfully obtain reimbursement for
health care products or services from government health
programs, such as Medicare and Medicaid. These laws apply
broadly and may constrain Cornerstones business and the
financial arrangements through which it markets, sells and
distributes its products. These laws and regulations include:
|
|
|
|
|
Federal Anti-Kickback Law. The anti-kickback
law contained in the federal Social Security Act is a criminal
statute that makes it a felony for individuals or entities
knowingly and willfully to offer or pay, or to solicit or
receive, direct or indirect remuneration, in order to induce
business reimbursed under a federal health care program,
including Medicare and Medicaid. The term
remuneration was intended to be and has been
interpreted broadly and includes both direct and indirect
compensation. Both the party offering and paying remuneration
and the recipient may be found to have violated the statute.
Courts have interpreted the anti-kickback law to cover any
arrangement where one purpose of the remuneration is to obtain
money for the referral of services or to induce further
referrals, regardless of whether there are also legitimate
purposes for the arrangement. There are narrow exclusions
authorizing arrangements that strictly comply with specified
safe harbor criteria, but many legitimate transactions fall
outside of the scope of any safe harbor standard, although that
does not necessarily mean the arrangement will be subject to
penalties under the anti-kickback statute. Penalties for federal
anti-kickback violations are severe, including up to five years
imprisonment, individual and corporate criminal fines, exclusion
from participation in federal health care programs and civil
monetary penalties in the form of treble damages plus $50,000
for each violation of the statute. It is possible that
government regulators may find that Cornerstones
arrangements do not comply with this broad and often ambiguous
law, to the extent it is determined that the statute is
implicated by any of Cornerstones arrangements.
|
|
|
|
Stark Law. The federal Statute on Limitations
of Certain Physician Referrals, commonly referred to as the
Stark Law, prohibits physician referrals for designated health
services to entities in which the referring physician or an
immediate family member has a financial interest, either through
an ownership or investment interest or a compensation
arrangement, unless the arrangement falls within a specific,
narrow exception. Manufacturers and suppliers are prohibited
from submitting and receiving federal health care program
reimbursement for products or services sold as a result of
prohibited referrals. Violations of the statute can result in
civil monetary penalties and exclusion from federal
|
231
|
|
|
|
|
heath care programs. It is possible that Cornerstones
physician customers may have certain financial interests
prohibited by the Stark Law.
|
|
|
|
|
|
State Laws. Various states have enacted laws
and regulations comparable to the federal fraud and abuse laws
and regulations. These state laws may apply to items or services
reimbursed by any third-party payor, including private,
commercial insurers and other payors. Moreover, these laws vary
significantly from state to state and, in some cases, are
broader than the federal laws. This increases the costs of
compliance and the risk that the same arrangements may be
subject to different compliance standards in different states.
|
Corporate
Organization
Cornerstone is comprised of Cornerstone BioPharma Holdings,
Inc., or Holdings, and its subsidiaries. Holdings was
incorporated in Delaware in 2005. Cornerstones operations
are performed primarily by a subsidiary of Holdings, Cornerstone
BioPharma, Inc., which was incorporated in Nevada in 2004 as
Cornerstone Pharmaceuticals, Inc. Holdings acquired Cornerstone
BioPharma, Inc. in 2005 from Cornerstone Biopharma Holdings,
Ltd., a company under common control with Holdings.
Employees
As of September 15, 2008, Cornerstone had 78 full-time
and five part-time employees, 65 of whom were engaged in
marketing and sales; four of whom were engaged in research,
development and regulatory affairs; and 14 of whom were engaged
in management, administration and finance. None of
Cornerstones employees are represented by a labor union or
covered by a collective bargaining agreement, and Cornerstone
has not experienced any work stoppages. Cornerstone believes
that relations with its employees are good.
Properties
In August 2004, Cornerstone entered into a lease agreement with
Regency Park Corporation to lease its corporate headquarters. In
January 2005, Cornerstone and Regency Park Corporation agreed to
amend the lease agreement to add additional office space and
adjust the annual rent accordingly. Currently, the corporate
headquarters occupies approximately 7,800 square feet of
office space and is located at 2000 Regency Parkway, an office
complex in Cary, North Carolina. The lease has five-year term
expiring in October 2009. Cornerstone paid an annual rent under
this lease of approximately $157,000 during 2007. In addition to
rent, Cornerstone is obligated to pay certain operating expenses
and taxes. Cornerstone is currently in negotiations with the
landlord under this lease concerning the terms and conditions
that would apply to an early termination of the lease in
connection with the relocation of Cornerstones corporate
headquarters as described below.
In May 2008, Cornerstone entered into a lease agreement with
Crescent Lakeside, LLC for a new corporate headquarters, which
will occupy approximately 14,900 square feet of office
space. The new corporate headquarters will be located at 1255
Crescent Green in the Crescent Lakeside office complex, in Cary,
North Carolina. The lease has an initial term that commences in
December 2008 and expires in March 2016. Cornerstone also
has an option to renew the lease for an additional five-year
term through March 2021. Initial annual base rent under the
lease is approximately $350,000 with annual rent increases of
approximately three percent. In addition to rent, Cornerstone is
obligated to pay certain operating expenses and taxes.
Legal
Proceedings
In November 2006, Cornerstone was named as a defendant in an
action filed in New York County, New York by Adams captioned
Adams Respiratory Therapeutics, Inc. (f/k/a Adams
Laboratories, Inc.) v. Cornerstone BioPharma, Inc. and
Carolina Pharmaceuticals, Inc., Supreme Court of the State
of New York, New York County, Index No. 603969/2006. The
complaint alleged breach of contract concerning a settlement
agreement between Cornerstone and Adams dated January 14,
2005. The complaint also alleged claims concerning the
settlement agreement for account stated, fraudulent
misrepresentation and negligent misrepresentation. The complaint
sought damages ranging from approximately $910,000 to an
unspecified amount in excess of $2.5 million. Cornerstone
filed an answer to the complaint in which it denied the material
allegations of the
232
Complaint and asserted counterclaims against Adams for breach of
contract concerning the settlement agreement. Cornerstones
counterclaims sought damages in excess of $2 million.
Following mediation in March 2008, the parties reached an
agreement to settle all matters between them, which resulted in
the parties execution of a new settlement agreement in May
2008. The litigation was dismissed, subject to the filing of a
motion by Adams to reinstate the litigation on or before
October 15, 2008 in the event of a default by Cornerstone
and Carolina Pharmaceuticals under the new settlement agreement.
Under the terms of the new settlement agreement, Cornerstone and
Carolina Pharmaceuticals agreed to pay Reckitt Benckiser, Inc.,
the parent of Adams, $1.5 million, of which
$1.0 million had been paid by the end of June 2008 and the
remaining $500,000 is due and payable by the end of September
2008.
Prior to March 2008, Cornerstone used a different formulation
for ALLERX 10 Dose Pack and ALLERX 30 Dose Pack that Cornerstone
believes was protected under claims in the U.S. patent
number 6,270,796, or the 796 Patent. Cornerstone and J-Med
Pharmaceuticals, Inc., or J-Med, the licensor of the 796
Patent, have asserted infringements of the 796 Patent in
litigation with each of Everton Pharmaceuticals, LLC,
Breckenridge Pharmaceuticals, Inc., and Vision, and
manufacturers and related parties of each, alleging that those
parties had infringed the 796 Patent by making, using,
selling, offering for sale or importing into the United States
pharmaceutical products intended as generic equivalents to the
former formulation of ALLERX 10 Dose Pack and ALLERX 30 Dose
Pack protected under claims in the 796 Patent. Everton and
Breckenridge entered into settlement agreements in January 2007
and July 2007, respectively, and agreed to cease selling the
infringing products. In October 2007, Cornerstone and J-Med
filed an action in the U.S. District Court for the Eastern
District of North Carolina against Vision and Nexgen Pharma,
Inc. captioned Cornerstone BioPharma, Inc. and J-Med
Pharmaceuticals, Inc. v. Vision Pharma, LLC and Nexgen
Pharma, Inc.,
No. 5:07-CV-00389-F.
In this action, Cornerstone and J-Med alleged that the product
known as
VisRx
infringes the 796 Patent. On November 19, 2007,
Cornerstone and J-Med filed an amended complaint in which they
asserted claims against Visions principals, Sander Busman,
Thomas DeStefano and Michael McAloose. On November 30,
2007, defendants moved to stay the litigation pending the
re-examination of the 796 Patent. The Court granted
defendants motion and stayed the litigation pending the
re-examination
of the 796 Patent on February 15, 2008. Separately,
the U.S. Patent and Trademark Office ordered a
re-examination of the 796 Patent as a result of a
third-party request for ex parte re-examination.
In proceedings before a re-examination examiner in the
U.S. Patent and Trademark Office, the examiner rejected
claims of the 796 Patent as failing to satisfy novelty and
non-obviousness criteria for U.S. patent claims. J-Med
appealed to the U.S. Patent and Trademark Office Board of
Patent Appeals and Interferences, or Board of Patent Appeals, on
June 13, 2008, seeking reversal of the examiners
rejections. On the same date,
J-Med filed
additional documents with the U.S. Patent and Trademark
Office for review by the examiner. If the examiner does not
reverse his prior rejections, then the Board of Patent Appeals
will act on the case and can take various actions, including
affirming or reversing the examiners rejections in whole
or part, or introducing new grounds of rejection of the
796 Patent claims. If the Board of Patent Appeals
thereafter affirms the examiners rejections, J-Med can
take various further actions, including requesting
reconsideration by the Board of Patent Appeals, filing a further
appeal to the U.S. Court of Appeals for the Federal Circuit
or instituting a reissue of the 796 Patent with narrowed
claims. The further proceedings involving the 796 Patent
therefore may be lengthy in duration, and may result in
invalidation of some or all of the claims of the 796
Patent.
On June 13, 2008, counsel for Vision filed in the
U.S. Patent and Trademark Office a request for
re-examination of certain claims under the 372 Patent,
which Cornerstone believes covers ALLERX 10 Dose Pack, ALLERX 30
Dose Pack, ALLERX Dose Pack PE and ALLERX Dose Pack PE 30.
Counsel for Cornerstone reviewed the request for re-examination
and the patents and publications cited by counsel for Vision,
and Cornerstones counsel have concluded that valid
arguments exist for distinguishing the claims of the 372
Patent over the references cited in the request for
re-examination. On August 21, 2008, the U.S. Patent
and Trademark Office determined that a substantial new question
of patentability was raised by the patents and publications
cited by Vision. Cornerstone will have the opportunity in
coordination with the patent owner, Pharmaceutical Innovations,
to present substantive arguments supporting the patentability of
the claims issued in the 372 Patent. If the
re-examination
examiner in the U.S. Patent and Trademark Office rejects
claims of the 372 Patent, Pharmaceutical Innovations may
appeal to the Board of Patent Appeals to seek reversal of the
examiners rejections. If Pharmaceutical Innovations did
not
233
receive relief from the Board of Patent Appeals, Pharmaceutical
Innovations could file a further appeal to the U.S. Court
of Appeals for the Federal Circuit or could institute a reissue
of the 372 Patent with narrowed claims. The further
proceedings involving the 372 Patent therefore may be
lengthy in duration, and may result in invalidation of some or
all of the claims of the 372 Patent.
In February 2008, Cornerstone filed a Notice of Opposition
before the Trademark Trial and Appeal Board in relation to
Application No. 77/226,994 filed in the U.S. Patent
and Trademark Office by Vision, seeking registration of the mark
VisRx. The
opposition proceeding is captioned Cornerstone BioPharma,
Inc. v. Vision Pharma, LLC, Opposition
No. 91182604. In April 2008, Vision filed an Answer to
Notice of Opposition and Counterclaims in which it requested
cancellation of U.S. Registrations No. 3,384,232 and
2,448,112 for the mark
ALLERX owned by
Cornerstone. Vision did not request monetary relief. Cornerstone
responded to the counterclaims by Vision on May 16, 2008.
Discovery in this proceeding is now underway. Cornerstone
intends to defend its interests vigorously against the
counterclaims asserted by Vision.
On May 15, 2008, the U.S. Patent and Trademark Office
sent written notice to Cornerstone that a cancellation
proceeding had been initiated by Bausch & Lomb
Incorporated, or Bausch & Lomb, against the ALLERX
trademark registration. The petition to cancel filed in this
proceeding alleges that the ALLERX registration dilutes the
distinctive quality of Bausch & Lombs
Alrex®
trademark and that Bausch & Lomb is likely to be
damaged by the ALLERX registration. Cornerstone is currently
engaged in settlement discussions with Bausch & Lomb
concerning a refinement of the product description in the ALLERX
trademark registration to distinguish it from the product
marketed by Bausch & Lomb under the Alrex trademark.
Cornerstone responded to the Trademark Trial and Appeal Board on
June 24, 2008, opposing the claims in the
Bausch & Lomb cancellation petition, while
concurrently continuing to seek settlement of the cancellation
proceeding on favorable terms. Cornerstone could take any of
numerous courses of action, including continuing to oppose the
claims of Bausch & Lomb, undertaking action to cancel
Bausch & Lombs registration of its
Alrex®
trademark or entering into discovery. A final decision by the
Trademark Trial and Appeal Board could take several years.
234
CRITICAL
THERAPEUTICS MANAGEMENTS DISCUSSION AND ANALYSIS
OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of
financial condition and results of operations together with the
Selected Historical Consolidated Financial Data of
Critical Therapeutics section of this proxy
statement/prospectus and Critical Therapeutics
consolidated financial statements and the related notes included
in this proxy statement/prospectus. In addition to historical
information, the following discussion contains forward-looking
statements that involve risks, uncertainties and assumptions.
Critical Therapeutics actual results could differ
materially from those anticipated by the forward-looking
statements due to important factors including, but not limited
to, those set forth in the Risks Related to Critical
Therapeutics section of this proxy statement/prospectus.
Overview
Critical Therapeutics is a biopharmaceutical company focused on
the development and commercialization of products designed to
treat respiratory diseases, as well as other inflammatory
diseases linked to the bodys inflammatory response.
Critical Therapeutics two marketed products are ZYFLO CR,
which the FDA approved in May 2007, and ZYFLO, which the FDA
approved in 1996, for the prevention and chronic treatment of
asthma in adults and children 12 years of age or older.
Critical Therapeutics licensed from Abbott exclusive worldwide
rights to ZYFLO CR, ZYFLO and other formulations of zileuton for
multiple diseases and conditions.
Critical Therapeutics began selling ZYFLO CR in the United
States in September 2007 and began selling ZYFLO in the United
States in October 2005. In February 2008, Critical Therapeutics
stopped the manufacture and supply of ZYFLO to the market. In
March 2008, Critical Therapeutics began to experience supply
chain issues with batches of ZYFLO CR that could not be released
into the commercial supply chain because they did not meet its
product release specifications. In September 2008, Critical
Therapeutics resumed distribution of ZYFLO to help manage any
potential impact to patients of supply chain issues for ZYFLO CR.
In addition, Critical Therapeutics is developing zileuton
injection initially for use in emergency room or urgent care
centers for patients who suffer acute exacerbations of asthma.
In June 2008, Critical Therapeutics announced results from its
Phase II clinical trial with zileuton injection in patients
with chronic, stable asthma. Critical Therapeutics intends to
initiate a process to seek to enter into a collaboration
agreement for the future clinical development and
commercialization of zileuton injection.
Critical Therapeutics is also developing other product
candidates directed towards reducing the potent inflammatory
response that it believes is associated with the pathology,
morbidity and, in some cases, mortality in many acute and
chronic diseases. The inflammatory response occurs following
stimuli such as infection or trauma. Critical Therapeutics
product candidates target the production and release into the
bloodstream of proteins called cytokines that play a fundamental
role in the bodys inflammatory response.
Critical Therapeutics has been conducting preclinical work in
its alpha-7 program. Critical Therapeutics believes the
successful development of a small molecule product candidate
targeting the alpha-7 receptor could lead to a novel treatment
for severe acute inflammatory disease, as well as an oral
anti-cytokine therapy that could be directed at chronic
inflammatory diseases such as asthma and rheumatoid arthritis.
Based on preclinical studies, Critical Therapeutics selected
lead and backup molecules for evaluation in GLP toxicology
studies. Provided the data are supportive and sufficient
resources are available, Critical Therapeutics believes that an
IND could be filed in 2009. In addition, Critical Therapeutics
plans to seek collaborations with other pharmaceutical companies
for its alpha-7 program to develop and commercialize possible
product candidates in multiple development opportunities that
may exist within this program prior to the initiation of human
clinical trials. Critical Therapeutics licensed to SetPoint
patent rights and know-how relating to the mechanical and
electrical stimulation of the vagus nerve. This license
agreement specifically excludes from the licensed field
pharmacological modulation of the alpha-7 receptor.
Critical Therapeutics has a collaboration agreement with
MedImmune for the development of monoclonal antibodies directed
toward an HMGB1, which Critical Therapeutics believes may be an
important target for
235
the development of products to treat diseases mediated by the
bodys inflammatory response. In addition, Critical
Therapeutics has a collaboration agreement with Beckman Coulter
for the development of a diagnostic directed toward measuring
HMGB1 in the bloodstream.
Until the closing of the proposed merger with Cornerstone,
Critical Therapeutics expects to continue its commercial and
development activities in accordance with its existing business
strategy with an increased focus on managing its cash position.
The description of Critical Therapeutics business set
forth in this proxy statement/prospectus does not reflect any
changes to Critical Therapeutics business that may occur
if it consummates the proposed merger with Cornerstone. For
instance, the combined companys clinical and preclinical
pipeline will include a number of product candidates. The
combined company is expected to implement a strategic review of
its product development pipeline. Following the strategic
review, the combined company may seek to maximize the value of
any non-core programs through out-licensing, divestiture or
spin-off
transactions.
On April 21, 2008, Critical Therapeutics received
notification that for the prior 30 consecutive business days the
bid price of its common stock on The NASDAQ Global Market had
closed below the minimum $1.00 per share required for
continued inclusion under NASDAQ Marketplace
Rule 4450(a)(5).
On May 16, 2008, Critical Therapeutics received
notification that its stockholders equity of $7,126,000,
as reported in its Quarterly Report on
Form 10-Q
for the quarter ended March 31, 2008 that it filed with the
SEC, does not comply with the minimum stockholders equity
requirement of $10,000,000 for continued listing on The NASDAQ
Global Market pursuant to NASDAQ Marketplace
Rule 4450(a)(3).
On June 13, 2008, NASDAQ approved the transfer of the
listing of Critical Therapeutics common stock from The
NASDAQ Global Market to The NASDAQ Capital Market effective at
the opening of business on June 17, 2008. A condition to
approval of the transfer of the listing was Critical
Therapeutics satisfaction of The NASDAQ Capital
Markets continued listing requirements, other than the
$1.00 per share minimum bid price requirement. Separately, if
Critical Therapeutics meets all of The NASDAQ Capital
Markets initial listing requirements, other than the
minimum bid price requirement, on October 20, 2008, which
is the date that is 180 days following the date Critical
Therapeutics received notification from NASDAQ that it failed to
comply with the minimum bid price requirement, Critical
Therapeutics will have the remainder of an additional 180
calendar day grace period while listed on The NASDAQ Capital
Market to regain compliance with NASDAQs minimum bid price
requirement. There can be no assurance that on October 20,
2008 Critical Therapeutics will comply with The NASDAQ Capital
Markets initial listing requirements, including The NASDAQ
Capital Markets minimum stockholders equity
requirement.
On August 13, 2008, Critical Therapeutics received
notification from the NASDAQ Listing Qualification Department
that, based on its stockholders equity of
$1.2 million, as reported in its Quarterly Report on
Form 10-Q for the quarter ended June 30, 2008, and a market
value of its common stock as of August 12, 2008 of
$13.0 million, Critical Therapeutics does not comply with
NASDAQ Marketplace Rule 4310(c)(3), which requires it to
have, for continued listing on The NASDAQ Capital Market, a
minimum of $2.5 million in stockholders equity or
market value of listed securities of $35.0 million or
$500,000 of net income from continuing operations for the most
recently completed fiscal year or two of the three most recently
completed fiscal years. As a result, the Listing Qualifications
Staff is reviewing Critical Therapeutics eligibility for
continued listing on The NASDAQ Capital Market. To facilitate
the review, Critical Therapeutics provided to the Listing
Qualifications Staff on September 3, 2008 a definitive
plan, based on completing the proposed merger with Cornerstone,
to achieve and sustain compliance with all NASDAQ Capital Market
listing requirements. If after the conclusion of its review
process the Listing Qualifications Staff determines that
Critical Therapeutics plan does not adequately address the
deficiencies noted, the Staff will provide written notice to
Critical Therapeutics that its common stock will be delisted
from The NASDAQ Capital Market. In such event, Critical
Therapeutics may appeal the Staffs decision to a NASDAQ
Listing Qualifications Panel.
Financial
Operations Overview
On March 13, 2007, Critical Therapeutics entered into an
agreement with DEY under which Critical Therapeutics and DEY
agreed to jointly promote ZYFLO and ZYFLO CR. Under the
co-promotion agreement,
236
DEY paid Critical Therapeutics a non-refundable upfront payment
of $3.0 million upon signing the
co-promotion
agreement, a milestone payment of $4.0 million following
approval by the FDA of the NDA for ZYFLO CR and a milestone
payment of $5.0 million following Critical
Therapeutics commercial launch of ZYFLO CR. Critical
Therapeutics, in accordance with EITF
02-16, has
deferred the $12.0 million in aggregate payments received
to date and is amortizing these payments over the term of the
agreement. The amortization of the upfront and milestone
payments will be offset by the co-promotion fees paid to DEY for
promoting ZYFLO and ZYFLO CR. Critical Therapeutics records any
co-promotion fees paid to DEY and the amortization of the
upfront and milestone payments as sales and marketing expenses.
Under the co-promotion agreement, Critical Therapeutics records
all quarterly net sales of ZYFLO CR and ZYFLO, after third-party
royalties, up to $1.95 million and pays DEY a commission on
quarterly net sales of ZYFLO CR and ZYFLO, after third-party
royalties, in excess of $1.95 million.
At June 30, 2008, Critical Therapeutics had
$7.8 million in inventory. Critical Therapeutics expects
that its inventory levels in the second half of 2008 will
increase as a result of its API purchase commitments in the
fourth quarter. Significant differences between Critical
Therapeutics current estimates and judgments and future
estimated demand for its products and the useful life of
inventory may result in significant charges for excess inventory
or purchase commitments in the future. These differences could
have a material adverse effect on its financial condition and
results of operations during the period in which Critical
Therapeutics recognizes charges for excess inventory. For
example, in the quarter ended June 30, 2008, Critical
Therapeutics recorded an inventory reserve with respect to an
aggregate of eight batches of ZYFLO CR that were not released
into Critical Therapeutics commercial supply chain,
consisting of one batch of ZYFLO CR that did not meet Critical
Therapeutics product release specifications and an
additional seven batches of ZYFLO CR that were on quality
assurance hold and that did not complete manufacturing within
the NDA-specified manufacturing timelines. In addition, in the
quarters ended December 31, 2007 and March 31, 2008,
Critical Therapeutics recorded inventory reserves with respect
to an aggregate of eight batches of ZYFLO CR that could not be
released into Critical Therapeutics commercial supply
chain because they did not meet Critical Therapeutics
product release specifications. These charges were included in
cost of products sold in the statements of operations for these
periods. In conjunction with Critical Therapeutics three
third-party manufacturers for zileuton API, tablet cores and
coating and release, Critical Therapeutics has initiated an
investigation to determine the cause of this issue, but the
investigation is ongoing and is not yet complete. Critical
Therapeutics has incurred and expects to continue to incur
significant costs in connection with its investigation. To date,
the investigation has not identified a clear source of the
issue. In August and September 2008, Critical Therapeutics
released and made available for shipment to wholesale
distributors an aggregate of six batches of finished ZYFLO CR
tablets that met its product release specifications. Critical
Therapeutics is currently unable to accurately assess the timing
and quantity of future batches of ZYFLO CR, if any, that may be
released for commercial supply. If not corrected, the ongoing
supply chain difficulties could prevent Critical Therapeutics
from supplying any further product to its wholesale
distributors. Based on its current level of sales and the
release of the six batches of ZYFLO CR in August and September
2008, Critical Therapeutics estimates that wholesale
distributors and retail pharmacies will have a sufficient
inventory of ZYFLO CR to continue to provide product to patients
through the fourth quarter of 2008.
Currently, Critical Therapeutics purchases its API for
commercial requirements for ZYFLO CR and ZYFLO from a single
source. In addition, Critical Therapeutics currently contracts
with single third parties for the manufacture of uncoated ZYFLO
CR tablets, for the entire manufacturing of ZYFLO tablets and
the coating and packaging of ZYFLO CR tablets. The disruption or
termination of the supply of API, a significant increase in the
cost of the API from this single source or the disruption or
termination of the manufacturing of Critical Therapeutics
commercial products could have a material adverse effect on its
business, financial position and results of operations.
As it moves forward with its proposed merger with Cornerstone,
Critical Therapeutics is continuing to focus on conserving cash
resources and has begun to take steps to reduce spending on
development programs and personnel. On May 8, 2008, as part
of this effort, Critical Therapeutics announced that it had
eliminated six positions, or approximately 8% of its workforce.
The headcount reductions primarily affect Critical
Therapeutics research and development group. In addition,
on June 12, 2008, Critical Therapeutics announced that it
eliminated an additional 15 positions, or approximately 23% of
its remaining workforce during the
237
month of June. The June 2008 headcount reductions primarily
affect employees performing sales and development functions.
Critical Therapeutics may consider further reductions in
headcount in additional areas of its business in the future in
order to conserve cash and reduce expenses. The nature, extent
and timing of future reductions will be made based on Critical
Therapeutics business needs and financial resources.
In connection with the implementation of the May 8, 2008
and June 12, 2008 reductions in its workforce, Critical
Therapeutics recorded a charge of approximately
$1.2 million of severance benefits in the second quarter of
2008.
On June 25, 2007, Critical Therapeutics entered into a
definitive agreement with DEY to jointly promote PERFOROMIST,
DEYs product for the treatment of COPD. Under the
agreement, DEY granted Critical Therapeutics a right and license
or sublicense to promote and detail PERFOROMIST in the United
States, together with DEY. In October 2007, Critical
Therapeutics announced that it had commercially launched
PERFOROMIST with DEY. Under the agreement, DEY pays Critical
Therapeutics a commission on retail sales of PERFOROMIST above a
specified baseline. On July 2, 2008, Critical Therapeutics
provided notice to DEY that Critical Therapeutics had exercised
its contractual right to terminate the co-promotion agreement
for PERFOROMIST. The termination is effective September 30,
2008.
In July 2003, Critical Therapeutics entered into an exclusive
license and collaboration agreement with MedImmune for the
discovery and development of novel drugs for the treatment of
acute and chronic inflammatory diseases associated with HMGB1.
Under this collaboration, MedImmune paid Critical Therapeutics
initial fees of $10.0 million in late 2003 and
$2.5 million in early 2004. In addition, MedImmune agreed
to pay Critical Therapeutics $125,000 in 2007, $1.0 million
in 2006, $2.75 million in 2005 and $1.5 million in
2004 for milestone payments and to fund certain research
expenses incurred by Critical Therapeutics for the HMGB1
program. The total $17.9 million in initial fees and
research funding was recognized over the term of the research
portion of the license and collaboration agreement using the
proportional performance method.
In January 2007, Critical Therapeutics entered into an exclusive
license agreement with SetPoint under which Critical
Therapeutics licensed to SetPoint patent rights and know-how
relating to the mechanical and electrical stimulation of the
vagus nerve. In May 2007, under the agreement with SetPoint,
Critical Therapeutics received an initial license fee of
$500,000 in cash and SetPoint junior preferred stock valued at
$500,000 in connection with SetPoints first financing.
However, under Critical Therapeutics license agreement
with The Feinstein Institute, Critical Therapeutics was
obligated to pay The Feinstein Institute $100,000 of this cash
payment and SetPoint junior preferred stock valued at $100,000.
Critical Therapeutics included in revenue under collaboration
and license agreements in 2007 the $1.0 million total
license fee that it received from SetPoint and included in
research and development expenses the payments of $100,000 in
cash and SetPoint junior preferred stock valued at $100,000 that
it made to The Feinstein Institute. These amounts were recorded
in the second quarter of 2007. Under the license agreement,
SetPoint also has agreed to pay Critical Therapeutics
$1.0 million, excluding a $200,000 payment that Critical
Therapeutics would be obligated to pay The Feinstein Institute,
upon full regulatory approval of a licensed product by the FDA
or a foreign counterpart agency and royalties based on a net
sales of licensed products and methods by SetPoint and its
affiliates. In March 2008, Critical Therapeutics sold the
remaining 400,000 shares of junior preferred stock to two
investors, which had participated in SetPoints first
financing, for an aggregate purchase price of $400,000. The
purchase price is subject to adjustment if these investors sell
or receive consideration for these shares of junior preferred
stock pursuant to an acquisition of SetPoint prior to
February 1, 2009 at a price per share greater than they
paid Critical Therapeutics.
Going
Concern Assumption
Since its inception, Critical Therapeutics has incurred
significant losses each year. Critical Therapeutics had net
losses of $37.0 million in the year ended December 31,
2007 and $48.8 million in the year ended December 31,
2006. Critical Therapeutics had net losses of $17.4 million
in the six months ended June 30, 2008 and
$17.6 million in the six months ended June 30, 2007.
As of June 30, 2008, Critical Therapeutics had an
accumulated deficit of approximately $209 million. Critical
Therapeutics expects to incur significant losses for the
foreseeable future and may never achieve profitability. Although
the size and timing of its future operating losses are subject
to significant uncertainty, Critical Therapeutics expects its
operating losses to
238
continue over the next several years as its funds its
development programs, market and sell ZYFLO CR and prepare for
the potential commercial launch of its product candidates. Based
on its current operating plan, Critical Therapeutics believes
that its available cash and cash equivalents and anticipated
cash received from product sales will be sufficient to fund
anticipated levels of operations into the first quarter of 2009.
Since its inception, Critical Therapeutics has raised proceeds
to fund its operations through public offerings of common stock,
private placements of equity securities, revenues from sales of
ZYFLO and ZYFLO CR, payments from DEY under its zileuton
co-promotion agreement, debt financings, the receipt of interest
income, payments from its collaborators, MedImmune and Beckman
Coulter, license fees from SetPoint.
Revenues
From its inception on July 14, 2000 through the third
quarter of 2005, Critical Therapeutics derived all of its
revenues from license fees, research and development payments
and milestone payments that it has received from its
collaboration and license agreements with MedImmune and Beckman
Coulter. In the fourth quarter of 2005, Critical Therapeutics
began selling, and recognizing revenue from, ZYFLO. In September
2007, Critical Therapeutics began selling, and recognizing
revenue from, ZYFLO CR. In 2007, Critical Therapeutics also
recorded license revenue from its license agreement with
SetPoint. In February 2008, Critical Therapeutics stopped the
manufacture and supply of ZYFLO to the market. Critical
Therapeutics resumed distribution of ZYFLO in
September 2008.
Cost
of Products Sold
Cost of products sold consists of manufacturing, distribution
and other costs related to Critical Therapeutics
commercial products, ZYFLO and ZYFLO CR. In addition, it
includes royalties to third parties related to ZYFLO and ZYFLO
CR and any reserves established for excess or obsolete
inventory. Most of Critical Therapeutics manufacturing and
distribution costs are paid to third-party manufacturers.
However, there are some internal costs included in cost of
products sold, including salaries and expenses related to
managing Critical Therapeutics supply chain and for
certain quality assurance and release testing costs.
Research
and Development Expenses
Research and development expenses consist of costs incurred in
identifying, developing and testing product candidates. These
expenses consist primarily of salaries and related expenses for
personnel, fees paid to professional service providers for
monitoring and analyzing clinical trials, regulatory costs,
including user fees paid to the FDA, milestone payments to third
parties, costs related to the development of Critical
Therapeutics approved NDA for ZYFLO CR, costs of contract
research and manufacturing and the cost of facilities. In
addition, research and development expenses have included the
cost of Critical Therapeutics medical affairs and medical
information functions, which educated physicians on the
scientific aspects of Critical Therapeutics commercial
products and the approved indications, labeling and the costs of
monitoring adverse events. After FDA approval of a product
candidate, Critical Therapeutics records manufacturing expenses
associated with a product as cost of products sold rather than
as research and development expenses. Critical Therapeutics
expenses research and development costs and patent related costs
as they are incurred. Because of Critical Therapeutics
ability to utilize resources across several projects, many of
its research and development costs are not tied to any
particular project and are allocated among multiple projects.
Critical Therapeutics records direct costs on a
project-by-project
basis. Critical Therapeutics records indirect costs in the
aggregate in support of all research and development.
Development costs for clinical stage programs such as zileuton
injection tend to be higher than earlier stage programs such as
Critical Therapeutics HMGB1 and alpha-7 programs due to
the costs associated with conducting late stage clinical trials
and large-scale manufacturing.
Critical Therapeutics expects that research and development
expenses relating to its portfolio will fluctuate depending
primarily on the timing and outcomes of clinical trials, related
manufacturing initiatives and milestone payments to third
parties and the results of its decisions based on these
outcomes. Critical Therapeutics also expects manufacturing
expenses for some programs included in research and development
expenses to increase if it scales up production of zileuton
injection for later stages of clinical development.
239
Critical Therapeutics initiated a Phase IV clinical trial
in July 2007 related to ZYFLO CR to examine its potential
clinical benefits in the current patient treatment setting. In
March 2008, Critical Therapeutics discontinued the trial because
patient enrollment was significantly slower than it had
anticipated. In the first quarter of 2008, Critical Therapeutics
accrued $1.1 million related to costs to terminate the
clinical trial. These costs are included in research and
development expenses for the three months ended March 31,
2008. At June 30, 2008, $768,000 remains in accrued expenses
related to these termination costs.
As a result of the FDAs approval of the NDA for ZYFLO CR
in May 2007, Critical Therapeutics made milestone payments
totaling $3.1 million and accrued at present value an
additional $3.5 million related to milestone obligations
due on the first and second anniversaries of the FDAs
approval. Critical Therapeutics included these milestone
payments and accruals in research and development expenses in
its results for the second quarter of 2007 and included the
accretion of the discount related to the present value of the
milestone obligations in interest expense. At June 30, 2008,
Critical Therapeutics included $1.9 million related to milestone
obligations due on the first anniversary of the FDAs
approval in its accounts payable.
As part of the approval of the NDA for ZYFLO CR in May 2007, the
FDA required Critical Therapeutics to conduct a pediatric
clinical trial of ZYFLO CR as a post-approval commitment and
report the results to the FDA by June 2010. Critical
Therapeutics has not yet begun this pediatric clinical trial.
The actual costs and timing of this clinical trial and
associated activities are highly uncertain, subject to risk and
will change depending upon the design of the pediatric clinical
trial that is implemented. If Critical Therapeutics does not
successfully begin and complete this clinical trial in the time
required by the FDA, Critical Therapeutics ability to
market and sell ZYFLO CR may be hindered, and Critical
Therapeutics business may be harmed as a result.
Sales
and Marketing Expenses
Sales and marketing expenses consist primarily of salaries and
other related costs for personnel in sales, marketing, managed
care and sales operations functions, as well as other costs
related to ZYFLO CR and ZYFLO. Critical Therapeutics also
incurred marketing and other costs related to its launch of
ZYFLO CR in September 2007. Other costs included in sales and
marketing expenses include sales and marketing costs related to
Critical Therapeutics co-promotion and marketing
agreement, cost of product samples of ZYFLO CR and ZYFLO,
promotional materials, market research and sales meetings.
Critical Therapeutics expects to continue to incur sales and
marketing costs associated with enhancing Critical
Therapeutics sales and marketing functions and maintaining
Critical Therapeutics increased sales force to support
ZYFLO CR. In addition, under its co-promotion agreement with
DEY, Critical Therapeutics has deferred the $12.0 million
in aggregate upfront and milestone payments that it received in
2007. Critical Therapeutics is amortizing these payments over
the term of the agreement. The amortization of the upfront and
milestone payments will offset some or all of the co-promotion
fees paid to DEY for promoting ZYFLO CR and ZYFLO in future
periods under the agreement. Critical Therapeutics records all
ZYFLO CR and ZYFLO sales generated by the combined sales force
and records any co-promotion fees paid to DEY and the
amortization of the upfront and milestone payments in sales and
marketing expenses.
General
and Administrative Expenses
General and administrative expenses consist primarily of
salaries and other related costs for personnel in executive,
finance, accounting, legal, business development, information
technology and human resource functions. Other costs included in
general and administrative expenses include certain facility and
insurance costs, including director and officer liability
insurance, as well as professional fees for legal, consulting
and accounting services.
Critical
Accounting Policies
The discussion and analysis of Critical Therapeutics
financial condition and results of operations are based on
Critical Therapeutics consolidated financial statements,
which have been prepared in accordance with accounting
principles generally accepted in the United States of America.
The preparation of these financial
240
statements requires Critical Therapeutics to make estimates and
judgments that affect its reported assets and liabilities,
revenues and expenses, and other financial information. Actual
results may differ significantly from these estimates under
different assumptions and conditions. In addition, Critical
Therapeutics reported financial condition and results of
operations could vary due to a change in the application of a
particular accounting standard.
Critical Therapeutics regards an accounting estimate or
assumption underlying Critical Therapeutics financial
statements as a critical accounting estimate where:
|
|
|
|
|
the nature of the estimate or assumption is material due to the
level of subjectivity and judgment necessary to account for
highly uncertain matters or the susceptibility of such matters
to change; and
|
|
|
|
the impact of the estimates and assumptions on financial
condition or operating performance is material.
|
Critical Therapeutics significant accounting policies are
more fully described in the notes to its consolidated financial
statements included in this proxy statement/prospectus. Not all
of these significant accounting policies, however, fit the
definition of critical accounting estimates.
Critical Therapeutics has discussed its accounting policies with
the audit committee of its board of directors, and believes that
its estimates relating to revenue recognition, product returns,
inventory, accrued and prepaid expenses, short-term investments,
stock-based compensation and income taxes described below fit
the definition of critical accounting estimates.
Revenue
Recognition
Revenue from Product Sales. Critical
Therapeutics sells ZYFLO CR and ZYFLO primarily to
pharmaceutical wholesalers, distributors and pharmacies, which
have the right to return purchased product. Critical
Therapeutics commercially launched ZYFLO in October 2005 and
ZYFLO CR in September 2007. Critical Therapeutics recognizes
revenue from product sales in accordance with
SFAS No. 48, Revenue Recognition When Right of
Return Exists, or SFAS 48, which requires the amount of
future returns to be reasonably estimated. Critical Therapeutics
recognizes product sales net of estimated allowances for product
returns, estimated rebates in connection with contracts relating
to managed care, Medicaid and estimated chargebacks from
distributors and prompt payment and other discounts. Calculating
these gross-to-net sales adjustments involves estimates and
judgments based primarily on sales or invoice data and
historical experience.
Prior to the first quarter of 2007, Critical Therapeutics
deferred the recognition of revenue on ZYFLO product shipments
to wholesale distributors until units were dispensed through
patient prescriptions as it was unable to reasonably estimate
the amount of future product returns. Units dispensed are not
generally subject to return. In the first quarter of 2007, based
on its product return experience since it launched ZYFLO in
October 2005, Critical Therapeutics began recording revenue upon
shipment to third parties, including wholesalers, distributors
and pharmacies, and providing a reserve for potential returns
from these third parties, as sufficient history existed to make
such estimates. In connection with this change in estimate,
Critical Therapeutics recorded an increase in net product sales
in 2007 related to the recognition of revenue from product sales
that had been previously deferred, net of an estimate for
remaining product returns. This change in estimate totaled
approximately $953,000 and was reported in Critical
Therapeutics results for the first quarter of 2007.
Critical Therapeutics anticipates that the rate of return for
ZYFLO CR will be comparable to the historical rate of return for
ZYFLO. As a result, Critical Therapeutics recognizes revenue for
sales of ZYFLO CR upon shipment to third parties and records a
reserve for potential returns from these third parties based on
its product returns experience with ZYFLO and other factors.
Product Returns. Consistent with industry
practice, Critical Therapeutics offers customers the ability to
return products during the six months prior to, and the
12 months after, the product expires. At the time of its
commercial launch in October 2005, Critical Therapeutics began
shipping ZYFLO with an expiration date of 12 months. Since
its launch of ZYFLO, Critical Therapeutics has extended
ZYFLOs expiration date from 12 months to
24 months. In September 2007, Critical Therapeutics
launched ZYFLO CR, which currently has an expiration date of
18 months. Critical Therapeutics anticipates that the rate
of return for ZYFLO CR will be comparable to the historical rate
of return for ZYFLO as the products are substantially similar.
241
Critical Therapeutics may adjust its estimate of product
returns if it becomes aware of other factors that it believes
could significantly impact its expected returns. These factors
include Critical Therapeutics estimate of inventory levels
of its products in the distribution channel, the shelf life of
the product shipped, competitive issues, such as new product
entrants, and other known changes in sales trends. Critical
Therapeutics evaluates this reserve on a quarterly basis,
assessing each of the factors described above, and adjusts the
reserve accordingly. As a result of this ongoing evaluation,
Critical Therapeutics product return reserve for
ZYFLO CR was $119,000 as of June 30, 2008. Critical
Therapeutics expects to resume supply of ZYFLO in September 2008.
Prompt Payment Discounts. Critical
Therapeutics offers wholesale distributors a 2% prompt payment
discount as an incentive to remit payment within the first
30 days after the date of its invoice. Because its
wholesale distributors typically take the prompt payment
discount, Critical Therapeutics accrues 100% of the prompt
payment discounts, based on the gross amount of each invoice, at
the time of its original sale to them, and Critical Therapeutics
applies earned discounts at the time of payment. Critical
Therapeutics adjusts the accrual quarterly to reflect actual
experience. Historically, these adjustments have not been
material. Critical Therapeutics does not anticipate that future
changes to its estimates will have a material impact on its net
revenue.
Medicaid Rebates. Critical Therapeutics
participates in state Medicaid programs. Critical Therapeutics
records an accrual for rebates to be provided through the
Medicaid Drug Rebate Program as a reduction of sales when the
product is sold. Critical Therapeutics rebates individual states
for all eligible units purchased under the Medicaid program
based on a rebate per unit calculation, which is derived from
its Average Manufacturer Price. By statute, states are required
to report quarterly drug utilization data to labelers
participating in the Medicare or Medicaid rebate program after
each reporting period. Critical Therapeutics determines its
estimate of the Medicaid rebates accrual primarily based on
historical experience regarding Medicaid rebates, legal
interpretations of the applicable laws related to the Medicaid
program and any new information regarding changes in the
Medicaid programs regulations and guidelines that would
impact the amount of the rebates. Critical Therapeutics adjusts
the accrual rate quarterly to reflect actual experience.
Critical Therapeutics does not anticipate that future changes to
its estimates will have a material impact on its net revenue.
Chargebacks. Although Critical Therapeutics
sells ZYFLO and ZYFLO CR primarily to wholesale distributors, as
a result of participating in the Medicaid Drug Rebate Program,
certain governmental entities, such as the Department of
Veterans Affairs or Department of Defense, can purchase product
from its wholesalers at a specified discounted price. Critical
Therapeutics provides a credit to the wholesale distributor, or
a chargeback, representing the difference between the wholesale
distributors acquisition list price and the discounted
price. As a result, at the time Critical Therapeutics ships the
product and records the related sale, Critical Therapeutics must
estimate the likelihood that its products sold to wholesale
distributors might ultimately be sold to federal government
entities. Critical Therapeutics determines its estimates based
on the historical chargeback data Critical Therapeutics receives
from wholesalers, which detail historical buying patterns and
the applicable chargeback rates. Critical Therapeutics adjusts
the accrual rate quarterly to reflect actual experience.
Critical Therapeutics does not anticipate that future changes to
its estimates will have a material impact on its net revenue.
242
The following table provides a summary of activity with respect
to Critical Therapeutics sales allowances.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prompt
|
|
|
|
|
|
|
|
|
|
Sales
|
|
|
Payment
|
|
|
Medicaid
|
|
|
|
|
|
|
Returns
|
|
|
Discounts
|
|
|
Discounts
|
|
|
Chargebacks
|
|
|
Balance at January 1, 2005
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Current provision
|
|
|
|
|
|
|
54
|
|
|
|
38
|
|
|
|
|
|
Payments and credits
|
|
|
|
|
|
|
(33
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
|
|
|
|
21
|
|
|
|
38
|
|
|
|
|
|
Current provision
|
|
|
|
|
|
|
148
|
|
|
|
153
|
|
|
|
91
|
|
Changes in prior year estimate
|
|
|
|
|
|
|
|
|
|
|
(27
|
)
|
|
|
|
|
Payments and credits
|
|
|
|
|
|
|
(153
|
)
|
|
|
(87
|
)
|
|
|
(81
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
|
|
|
|
16
|
|
|
|
77
|
|
|
|
10
|
|
Current provision
|
|
|
1,411
|
|
|
|
238
|
|
|
|
263
|
|
|
|
131
|
|
Changes in prior year estimate
|
|
|
|
|
|
|
|
|
|
|
17
|
|
|
|
|
|
Payments and credits
|
|
|
(538
|
)
|
|
|
(229
|
)
|
|
|
(262
|
)
|
|
|
(128
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
873
|
|
|
|
25
|
|
|
|
95
|
|
|
|
13
|
|
Current provision
|
|
|
4
|
|
|
|
141
|
|
|
|
99
|
|
|
|
49
|
|
Changes in prior year estimate
|
|
|
(440
|
)
|
|
|
|
|
|
|
(18
|
)
|
|
|
5
|
|
Payments and credits
|
|
|
(318
|
)
|
|
|
(136
|
)
|
|
|
(134
|
)
|
|
|
(59
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2008
|
|
$
|
119
|
|
|
$
|
30
|
|
|
$
|
42
|
|
|
$
|
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue under Collaboration and License
Agreements. Under its collaboration agreements
with MedImmune and Beckman Coulter, Critical Therapeutics is
entitled to receive non-refundable license fees, milestone
payments and other research and development payments. Payments
received are initially deferred from revenue and subsequently
recognized in Critical Therapeutics statements of
operations when earned. Critical Therapeutics must make
significant estimates in determining the performance period and
periodically review these estimates, based on joint management
committees and other information shared by its collaborators.
Critical Therapeutics recognizes revenues under its
collaboration agreements over the estimated performance period
as set forth in the contracts based on proportional performance
adjusted from time to time for any delays or acceleration in the
development of the product. Critical Therapeutics assesses
proportional performance based on the progress of its research
and development efforts, including employees salaries and
benefits, laboratory supplies and third-party research
consulting fees, during the term of its agreements. Critical
Therapeutics considers these to be the most reliable measure of
progress. Because MedImmune and Beckman Coulter can each cancel
its agreement with it, Critical Therapeutics does not recognize
revenues in excess of cumulative cash collections. It is
difficult to estimate the impact of the adjustments on the
results of Critical Therapeutics operations because, in
each case, the adjustment is limited to the cash received. In
estimating the progress of its research and development
activities for the research portion of the MedImmune agreement,
Critical Therapeutics utilized assumptions regarding the major
drivers of the program, including the proposed duration of the
research term, the estimated time to complete the research phase
of the program and the expected costs of personnel, laboratory
supplies and third-party consulting required to complete its
obligations under the research plan. As a result of a change in
estimate of the term during which services would be provided
from 41 months to 47 months covered by its research
plan with MedImmune, Critical Therapeutics decreased revenue
recognized of approximately $237,000 in 2005. In addition, in
2006, Critical Therapeutics revised its estimate of remaining
total research and development costs to be incurred under the
collaboration agreement with MedImmune as a result of lower than
expected research and development costs incurred due to more
rapid advancement of the program. This change in estimate
resulted in an increase in revenue recognized of approximately
$2.0 million in 2006. All of Critical Therapeutics
research activities under the research plan with MedImmune were
completed in 2007. Critical Therapeutics had no changes in
estimates related to its agreement with Beckman Coulter.
243
Under its agreement with MedImmune, Critical Therapeutics may
receive, subject to the terms and conditions of the agreement,
other payments upon the achievement of development and
commercialization milestones by MedImmune up to a maximum of
$124.0 million, after taking into account payments that
Critical Therapeutics is obligated to make to The Feinstein
Institute. Critical Therapeutics has not recorded and will not
record these future development and commercialization milestones
until they are achieved.
Under its license agreement with SetPoint, Critical Therapeutics
included in revenue from collaboration and license agreements in
the second quarter of 2007 a $1.0 million initial license
fee that it received from SetPoint and included in research and
development expenses a related $100,000 cash payment and
SetPoint preferred stock payment valued at $100,000 that it made
to The Feinstein Institute.
Inventory
Inventory is stated at the lower of cost or market value with
cost determined under the
first-in,
first-out, or FIFO, method. Critical Therapeutics estimate
of the net realizable value of its inventories is subject to
judgment and estimation. The actual net realizable value of
Critical Therapeutics inventories could vary significantly
from its estimates and could have a material effect on Critical
Therapeutics financial condition and results of operations
in any reporting period. Critical Therapeutics determines the
estimated useful life of its inventory based upon stability data
of the underlying product stored at different temperatures or in
different environments. As of June 30, 2008, inventory
consists of API, which is raw material in powder form,
work-in-process
and finished tablets to be used for commercial sale. On a
quarterly basis, Critical Therapeutics analyzes its inventory
levels and writes down inventory that has become obsolete,
inventory that has a cost basis in excess of Critical
Therapeutics expected net realizable value and inventory
that is in excess of expected requirements based upon
anticipated product revenues. At June 30, 2008, Critical
Therapeutics had an inventory reserve of $2.5 million. The
inventory reserve includes $571,000 recorded in the fourth
quarter of 2007, $622,000 recorded in the first quarter of 2008,
$160,000 recorded in the second quarter of 2008 relating to nine
batches that did not meet Critical Therapeutics product
release specifications for ZYFLO CR and $1.1 million recorded in
the second quarter of 2008 relating to seven additional batches
of the tablet cores of ZYFLO CR that were on quality assurance
hold and that could not complete manufacturing within the
NDA-specified
manufacturing timelines. As of June 30, 2008, Critical
Therapeutics had $7.8 million in inventory, net of the
inventory reserve. Critical Therapeutics expects its inventory
levels to increase in the second half of 2008 as a result of its
API purchase commitments in the fourth quarter of 2008.
Accrued
Expenses
As part of the process of preparing Critical Therapeutics
consolidated financial statements, Critical Therapeutics is
required to estimate certain expenses. This process involves
identifying services that have been performed on Critical
Therapeutics behalf and estimating the level of service
performed and the associated cost incurred for such service as
of each balance sheet date in Critical Therapeutics
consolidated financial statements. Examples of estimated
expenses for which Critical Therapeutics accrues include
professional service fees, such as fees paid to lawyers and
accountants, rebates to third parties, including government
programs such as Medicaid or private insurers, contract service
fees, such as amounts paid to clinical monitors, data management
organizations and investigators in connection with clinical
trials, fees paid to contract manufacturers in connection with
the production of clinical materials, license fees in connection
with the achievement of milestones and restructuring charges.
In connection with rebates, Critical Therapeutics
estimates are based on its estimated mix of sales to various
third-party payors, which are either contractually or
statutorily entitled to certain discounts off Critical
Therapeutics listed price of ZYFLO and ZYFLO CR. In the
event that Critical Therapeutics sales mix to certain
third-party payors is different from its estimates, Critical
Therapeutics may be required to pay higher or lower total
rebates than it has estimated. In connection with service fees,
Critical Therapeutics estimates are most affected by its
understanding of the status and timing of services provided
relative to the actual levels of services incurred by such
service providers. The majority of Critical Therapeutics
service providers invoice it monthly in arrears for services
performed; however, certain service providers invoice it based
upon milestones in its agreements with them. In the event that
it does not identify certain costs that it has begun to
244
incur, or, under or over-estimates the level of services
performed or the costs of such services, Critical
Therapeutics reported expenses for such period would be
too low or too high. The date on which certain services
commence, the level of services performed on or before a given
date and the cost of such services are often subject to
judgment. Critical Therapeutics makes these judgments based upon
the facts and circumstances known to it in accordance with
generally accepted accounting principles.
Investments
Investments consist primarily of U.S. government treasury
and agency notes, corporate debt obligations, municipal debt
obligations, auction rate securities and money market funds,
each of investment-grade quality, which have an original
maturity date greater than 90 days. These investments are
recorded at fair value and accounted for as available-for-sale
securities. Critical Therapeutics records any unrealized gain
(loss) during the year as an adjustment to stockholders
equity unless it determines that the unrealized gain (loss) is
not temporary. Critical Therapeutics adjusts the original cost
of debt securities for amortization of premiums and accretion of
discounts to maturity. Because Critical Therapeutics has
determined that the unrealized gain (loss) on its investments
has been temporary, it has not recorded any impairment losses
since inception.
It is Critical Therapeutics intent to hold its investments
until such time as it intends to use them to meet the ongoing
liquidity needs of its operations. However, if the circumstances
regarding an investment, such as a change in an
investments external credit rating, or its liquidity needs
were to change, Critical Therapeutics would consider a sale of
the related security prior to the maturity of the underlying
investment to minimize any losses. At June 30, 2008,
Critical Therapeutics held $284,000 in an auction rate security.
In the first and second quarters of 2008, Critical Therapeutics
was informed that there was insufficient demand at auction for
this security. As a result, this amount is currently not liquid
and may not become liquid unless the issuer is able to refinance
it. Critical Therapeutics has classified its investment in an
auction rate security as a long-term investment and has included
the amount in other assets on its balance sheet.
Stock-Based
Compensation
Critical Therapeutics applies the fair value recognition
provisions of SFAS No. 123 (revised 2004),
Share-Based Payment, or SFAS 123(R), using the
modified prospective application method, which requires it to
recognize compensation cost for granted, but unvested awards
(upon adoption), new awards and awards modified, repurchased, or
cancelled after adoption under the fair value method.
Critical Therapeutics accounts for transactions in which
services are received in exchange for equity instruments based
on the fair value of such services received from non-employees
or of the equity instruments issued, whichever is more reliably
measured, in accordance with SFAS 123(R). Critical
Therapeutics uses the Black-Scholes option-pricing model to
calculate the fair value of stock-based compensation under
SFAS 123(R). There are a number of assumptions used to
calculate the fair value of stock options or restricted stock
issued to employees under this pricing model.
The two factors that most affect charges or credits to
operations related to stock-based compensation are the fair
value of the common stock underlying stock options for which
stock-based compensation is recorded and the volatility of such
fair value. Accounting for equity instruments granted by
Critical Therapeutics under SFAS 123(R) and EITF Issue
No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services, or
EITF 96-18,
requires fair value estimates of the equity instrument granted.
If Critical Therapeutics estimates of the fair value of
these equity instruments are too high or too low, it would have
the effect of overstating or understating expenses. When equity
instruments are granted or sold in exchange for the receipt of
goods or services and the value of those goods or services can
be readily estimated, Critical Therapeutics uses the value of
such goods or services to determine the fair value of the equity
instruments. When equity instruments are granted or sold in
exchange for the receipt of goods or services and the value of
those goods or services cannot be readily estimated, as is true
in connection with most stock options and warrants granted to
employees or non-employees, Critical Therapeutics estimates the
fair value of the equity instruments based upon the
245
consideration of factors that it deems to be relevant at the
time using cost, market or income approaches to such valuations.
Income
Taxes
As part of the process of preparing its consolidated financial
statements, Critical Therapeutics is required to estimate its
income taxes in each of the jurisdictions in which it operates.
This process involves estimating Critical Therapeutics
actual current tax exposure together with assessing temporary
differences resulting from differing treatments of items for tax
and accounting purposes. These differences result in deferred
tax assets and liabilities.
At December 31, 2007, Critical Therapeutics had federal tax net
operating loss carryforwards of approximately $163 million,
which expire beginning in 2021, and state tax net operating loss
carryforwards of approximately $154 million, which expire
beginning in 2008. Critical Therapeutics also has research and
experimentation credit carryforwards of approximately
$1.9 million as of December 31, 2007, which expire
beginning in 2021. Critical Therapeutics has recorded a full
valuation allowance as an offset against these otherwise
recognizable net deferred tax assets due to the uncertainty
surrounding the timing of the realization of the tax benefit. In
the event that Critical Therapeutics determines in the future
that it will be able to realize all or a portion of a net
deferred tax benefit, an adjustment to the deferred tax
valuation allowance would increase net income or additional paid
in capital for deferred tax assets related to stock compensation
deductions in the period in which such a determination is made.
The Tax Reform Act of 1986 contains provisions that may limit
the utilization of net operating loss carryforwards and credits
available to be used in any given year in the event of
significant changes in ownership interest, as defined therein.
Critical Therapeutics did not recognize any accrued interest and
penalties related to unrecognized tax benefits, as no amounts
would be due as a result of its net tax loss carryforward.
Critical Therapeutics policy is to record interest and
penalties related to unrecognized tax benefits in income tax
expense. Tax years for 2000 to 2007 remain subject to
examination for federal and numerous state jurisdictions. The
primary state tax jurisdiction to which Critical Therapeutics is
subject is the Commonwealth of Massachusetts.
Results
of Operations
Six
Months Ended June 30, 2008 and 2007
Revenues
Revenue from Product Sales. Critical
Therapeutics recognized revenue from product sales of ZYFLO CR
and ZYFLO of $7.2 million in the six months ended
June 30, 2008, compared to revenue from product sales of
ZYFLO of $5.2 in the six months ended June 30, 2007. The
increase in product revenue is primarily attributable to a 66%
increase in prescription volume over the corresponding period in
2007, an 11% increase in the wholesale acquisition price of
products sold from the corresponding period in 2007 and a
$884,000 reduction in Critical Therapeutics product return
expense for ZYFLO CR and ZYFLO from the corresponding period in
2007. In addition, in the six months ended June 30, 2007,
Critical Therapeutics recorded a $953,000 increase in product
sales related to the recognition of revenue from product sales
that had been previously deferred, net of an estimate for
remaining product returns. On January 1, 2007, based on
Critical Therapeutics product return experience since the
launch of ZYFLO in October 2005, Critical Therapeutics began
recording revenue upon shipment to third parties, including
wholesalers, distributors and pharmacies, and providing a
reserve for potential returns from these third parties, as
Critical Therapeutics was now able to estimate product returns.
Revenue under Collaboration and License
Agreements. Critical Therapeutics did not
recognize any collaboration or license revenue in the
six months ended June 30, 2008, compared to
$1.7 million recognized in collaboration and license
revenue in the six months ended June 30, 2007.
Collaboration revenue in the six months ended June 30,
2007 was primarily due to $737,000 in collaboration revenue from
Critical Therapeutics collaboration with MedImmune and
$1.0 million in license revenue related to Critical
Therapeutics license agreement with SetPoint.
Collaboration revenue of $737,000 related to the collaboration
246
with MedImmune and Beckman Coulter in the six months ended June
30, 2007 was primarily attributable to the recognition of
$400,000 of deferred revenue recognized under Critical
Therapeutics collaboration agreement with Beckman Coulter
for a license fee paid to develop a diagnostic assay in
connection with Critical Therapeutics HMGB1 program.
Collaboration revenue in the six months ended June 30,
2007 also included approximately $337,000 related to a portion
of the $12.5 million of initial fees MedImmune paid to
Critical Therapeutics that Critical Therapeutics recognized over
the duration of the contract and the $5.3 million
cumulatively billed to MedImmune for milestone payments and
development support from the inception of the agreement through
March 31, 2007. At June 30, 2008, Critical
Therapeutics had no deferred collaboration revenue and had
completed the research term of its agreement with MedImmune.
Critical Therapeutics revenue recognized from existing
collaborations for the remainder of 2008 is likely to decline
substantially compared to corresponding periods in 2007 because
Critical Therapeutics has now recognized all of the revenue that
it previously deferred. Going forward, Critical
Therapeutics revenue from collaboration agreements will
fluctuate each quarter and will be highly dependent upon the
achievement of milestones under its existing agreements, or will
be dependent upon entering into new collaboration agreements.
Costs and
Expenses
Cost of Products Sold. Cost of products sold
was $4.7 million in the six months ended June 30, 2008, compared
to $1.4 million in the six months ended June 30, 2007, an
increase of $3.2 million, or 228%. Gross margin was 36% for the
six months ended June 30, 2008 and 73% for the six months ended
June 30, 2007.
Cost of products sold in the six months ended June 30, 2008
consisted primarily of the expenses associated with
manufacturing ZYFLO CR and distributing ZYFLO and ZYFLO CR,
royalties to Abbott and Jagotec related to ZYFLO and ZYFLO CR
and reserves established for excess or obsolete inventory. Cost
of products sold in the six months ended June 30, 2007
consisted primarily of the expenses associated with
manufacturing and distributing ZYFLO and royalty payments to
Abbott under the license agreement for ZYFLO. As a result of
Critical Therapeutics change in estimates relating to
recognition of ZYFLO sales, Critical Therapeutics recorded an
additional $166,000 in cost of products sold in the six months
ended June 30, 2007.
Critical Therapeutics recorded inventory reserves of
$1.9 million for the six months ended June 30, 2008.
The write-offs in the six months ended June 30, 2008
resulted from five batches of ZYFLO CR that did not meet
Critical Therapeutics product release specifications and
seven additional batches of the tablet cores of ZYFLO CR that
were on quality assurance hold and that did not complete
manufacturing within the NDA-specified manufacturing timelines.
Critical Therapeutics did not record any inventory reserves
during the six months ended June 30, 2007. As a result of
the commercial launch of ZYFLO CR in September 2007, Critical
Therapeutics gross margins, excluding write-offs, will
likely decrease further as a result of an increase in cost of
products sold related to ZYFLO CR due to the more complex
manufacturing process and supply chain for ZYFLO CR and
additional royalty obligations to Abbott and to Jagotec for
utilization of its controlled-release technology. This likely
decrease could be offset, in part, by an increase in Critical
Therapeutics wholesale acquisition price of ZYFLO CR and
Critical Therapeutics ability to spread some of its fixed
costs associated with managing its supply chain over a larger
revenue base in 2008.
Research and Development Expenses. Research
and development expenses in the six months ended June 30,
2008 were $6.9 million, compared to $13.0 million in
the six months ended June 30, 2007, a decrease of
approximately $6.1 million, or 47%. This decrease was
primarily due to lower expenses associated with Critical
Therapeutics ZYFLO CR milestone fees paid and accrued for,
its Phase IV clinical trial and its
alpha-7 and
HMGB1 preclinical programs. These lower expenses were offset, in
part, by an increase in expenses related to Critical
Therapeutics zileuton injection Phase II clinical
trial costs.
247
The following table summarizes the primary components of
Critical Therapeutics research and development expenses
for the six months ended June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(In thousands)
|
|
|
Zileuton (ZYFLO and ZYFLO CR)
|
|
$
|
3,539
|
|
|
$
|
9,872
|
|
Zileuton injection
|
|
|
1,441
|
|
|
|
315
|
|
CTI-01
|
|
|
|
|
|
|
(83
|
)
|
Alpha-7
|
|
|
1,046
|
|
|
|
1,847
|
|
HMGB1
|
|
|
3
|
|
|
|
210
|
|
General research and development expenses
|
|
|
408
|
|
|
|
322
|
|
Stock-based compensation expense
|
|
|
490
|
|
|
|
539
|
|
|
|
|
|
|
|
|
|
|
Total research and development expenses
|
|
$
|
6,927
|
|
|
$
|
13,022
|
|
|
|
|
|
|
|
|
|
|
The following summarizes the expenses associated with Critical
Therapeutics primary research and development programs:
|
|
|
|
|
Zileuton (ZYFLO and ZYFLO CR). During the six
months ended June 30, 2008, Critical Therapeutics incurred
$3.5 million in expenses related to its orally-dosed
zileuton programs, including ZYFLO and ZYFLO CR, compared
to $9.9 million during the six months ended June 30,
2007, a decrease of $6.3 million, or 64%. This decrease was
primarily due to the following:
|
|
|
|
|
|
$3.1 million in milestone fees paid to third parties as a
result of the FDAs approval of the NDA for ZYFLO CR in May
2007;
|
|
|
|
$3.5 million in accrued milestone payments to third parties as a
result of the FDAs approval of the NDA for ZYFLO CR in May
2007, which are due on the first and second anniversaries of the
FDAs approval;
|
|
|
|
$902,000 reduction in salaries and other personnel related costs
as a result of Critical Therapeutics December 2006 and May
2007 restructurings and a reduction in associated facilities and
overhead costs;
|
|
|
|
$426,000 decrease in manufacturing costs related to Critical
Therapeutics R(+) isomer program for zileuton; and
|
|
|
|
$102,000 reduction in clinical and manufacturing costs for ZYFLO.
|
The decreases in the costs described above were partially offset
by a $1.3 million increase in clinical and manufacturing costs
related to Critical Therapeutics Phase IV clinical trial
for ZYFLO CR, which was discontinued in March 2008, and a
$393,000 asset impairment charge related to Critical
Therapeutics second supplier program for ZYFLO CR.
Critical Therapeutics does not expect to continue to incur
substantial research and development expenses for the remainder
of 2008 in support of ZYFLO CR.
|
|
|
|
|
Zileuton Injection. During the six months
ended June 30, 2008, Critical Therapeutics incurred
$1.4 million in expenses related to its zileuton injection
program, compared to $315,000 during the six months ended
June 30, 2007, an increase of $1.1 million, or 357%. This
increase was primarily due to clinical trial expenses related to
Critical Therapeutics Phase II clinical trial for
zileuton injection, which began in October 2007. As Critical
Therapeutics has completed the analysis of the data and reported
the results of the Phase II clinical trial, it does not
expect to incur additional costs associated with the development
of zileuton injection during the remainder of 2008. Critical
Therapeutics currently expects to seek a collaborator to develop
and commercialize its zileuton injection product candidate.
|
248
|
|
|
|
|
CTI-01. During the six months ended
June 30, 2008, Critical Therapeutics did not incur any
costs related to its CTI-01 program. During the six months ended
June 30, 2007, Critical Therapeutics received a net credit
of $83,000 related to its CTI-01 program clinical trial costs.
Effective February 2007, Critical Therapeutics terminated its
license agreements with the University of Pittsburgh and Xanthus
Pharmaceuticals Inc. related to the development of CTI-01.
Critical Therapeutics does not plan to pursue further
development of CTI-01 or to incur additional costs related to
CTI-01.
|
|
|
|
Alpha-7. During the six months ended
June 30, 2008, Critical Therapeutics incurred $1.0 million
in expenses related to its alpha-7 program, compared to $1.8
million during the six months ended June 30, 2007, a 43%
decrease. This decrease was primarily due to a reduction in the
number of employees working on the program and a reduction in
associated facilities and overhead costs. Critical Therapeutics
anticipates that the research and development expenses for its
alpha-7 program will not grow substantially for the remainder of
2008, as it expects increased costs related to preclinical
studies conducted by third parties to advance the lead molecule
to be offset by a reduced number of employees working on this
program. Critical Therapeutics anticipates that significant
additional expenditures will be required to advance any product
candidate through preclinical and clinical development. Critical
Therapeutics currently expects to seek a collaborator for its
alpha-7 program to develop and commercialize possible product
candidates. However, because this project is at a very early
stage of development, the actual costs and timing of research,
preclinical development, clinical trials and associated
activities are highly uncertain, subject to risk, and will
change depending upon the product candidate Critical
Therapeutics chooses to develop, the clinical indications
developed, the development strategy adopted, and the terms of a
collaboration, if it is able to enter into one. As a result,
Critical Therapeutics is unable to estimate the costs or the
timing of advancing a small molecule from its alpha-7 program
through clinical development.
|
|
|
|
HMGB1. During the six months ended
June 30, 2008, Critical Therapeutics incurred $3,000 in
expenses related to its HMGB1 program, compared to $210,000
during the six months ended June 30, 2007, a decrease of
$207,000, or 99%. Since the end of the second quarter of 2007,
Critical Therapeutics has not conducted, and currently does not
anticipate conducting in the future, any research and
development activities relating to the HMGB1 program. In
addition, all of the research and development expenses of the
HMGB1 program will be assumed by MedImmune as the program
advances into later stages of preclinical development. The
expenses for the HMGB1 program previously borne by Critical
Therapeutics are reflected in the accompanying statements of
operations as part of research and development expenses, while
any funding received from MedImmune and Beckman Coulter to
support Critical Therapeutics previous research efforts is
included in revenue under collaboration agreements.
|
Critical Therapeutics general research and development
expenses, which are not allocated to any specific program, were
$408,000 in the six months ended June 30, 2008, compared to
$322,000 in the six months ended June 30, 2007, an increase
of $86,000, or 27%. Critical Therapeutics general research
and development expenses, which are incurred in support of all
of its research and development programs, are not easily
allocable to any individual program and, therefore, have been
included in general research and development expenses.
In addition, Critical Therapeutics stock-based
compensation expense was $490,000 in the six months ended
June 30, 2008, compared to $539,000 in the six months ended
June 30, 2007, a decrease of $49,000, or 9%. This decrease
was primarily due to a continued reduction in stock-based
compensation expense related to the reduction in the number of
consultants and employees performing research and development
functions.
Sales and Marketing. Sales and marketing
expenses for the six months ended June 30, 2008 were
$6.0 million, compared to $4.6 million for the six
months ended June 30, 2007. The $1.4 million increase
was primarily attributable to the following:
|
|
|
|
|
$990,000 increase in salary and other costs of employees
performing sales and marketing functions;
|
|
|
|
$1.5 million increase related to promotional materials,
advertising and other costs associated with ZYFLO CR that
Critical Therapeutics incurred to support its co-promotion
agreement with DEY; and
|
|
|
|
$626,000 increase in co-promotion fees owed to DEY.
|
249
These increases were partially offset by the following:
|
|
|
|
|
$626,000 decrease related to amortization of Critical
Therapeutics deferred sales and marketing expense;
|
|
|
|
$830,000 decrease related to expenses to be reimbursed by DEY
associated with ZYFLO CR that Critical Therapeutics incurred to
support its co-promotion agreement; and
|
|
|
|
$257,000 decrease in sample costs.
|
The number of employees performing sales and marketing functions
increased to 34 employees at June 30, 2008 from
26 employees at June 30, 2007. Critical Therapeutics
expects that its sales and marketing costs will decrease during
the remainder of 2008 as it focuses on conserving cash resources
and realizes the anticipated benefits of its May and June 2008
restructuring plans.
General and Administrative Expenses. General
and administrative expenses for the six months ended
June 30, 2008 were $6.0 million, compared to
$6.6 million for the six months ended June 30, 2007, a
decrease of $578,000, or 9%. This decrease was primarily due to
a decrease of $905,000 in advisory fees paid in connection with
the signing of Critical Therapeutics agreement with DEY in
the first quarter of 2007 and a decrease of $411,000 in
stock-based compensation expense. These decreases were offset,
in part, by an increase of $724,000 in legal fees primarily
related to Critical Therapeutics proposed merger with
Cornerstone. The number of employees performing general and
administrative functions was 12 employees at June 30,
2008 and 14 employees at June 30, 2007. Critical
Therapeutics expects that its general and administrative
expenses will increase during the remainder of 2008 compared to
corresponding periods in 2007 as it incurs additional
professional fees relating to the proposed merger with
Cornerstone.
Restructuring Charges. Restructuring
charges totaled $1.2 million in the second quarter of 2008
related to actions Critical Therapeutics took in May and June
2008. In May 2008, Critical Therapeutics announced that it had
eliminated six positions, or approximately 8% of its workforce.
The headcount reduction primarily affected the research and
development group. In addition, in June 2008, Critical
Therapeutics announced that it had eliminated an additional 15
positions, or approximately 23% of its remaining workforce. The
June 2008 headcount reductions primarily affected employees
performing sales and development functions. Critical
Therapeutics expects to consider further reductions in its
headcount in additional areas of its business in the future in
order to conserve cash and reduce expenses. The nature, extent
and timing of future reductions will be made based on Critical
Therapeutics business needs and financial resources. The
restructuring charges for 2008 were comprised of
$1.2 million in severance, benefit and other related
payments, and $41,000 in vehicle lease termination charges,
asset impairment charges and outplacement services.
Other Income. Interest income for the six
months ended June 30, 2008 was $289,000, compared to
$1.2 million for the six months ended June 30, 2007, a
decrease of $865,000, or 75%. The decrease was primarily
attributable to lower average cash and investment balances and
lower interest rates. Interest expense amounted to $85,000 for
the six months ended June 30, 2008 and $69,000 for the six
months ended June 30, 2007. Interest expense primarily
relates to the accretion of the discount on Critical
Therapeutics accrued first and second anniversary
milestone payments owed to Abbott and Jagotec as a result of the
FDA approval of the NDA for ZYFLO CR and borrowings under
Critical Therapeutics loan with Silicon Valley Bank for
capital expenditures.
Years
Ended December 31, 2007 and 2006
Revenues
Revenue from Product Sales. Critical
Therapeutics recognized revenue from net product sales related
to sales of ZYFLO and ZYFLO CR of $11.0 million in 2007
compared to $6.6 million in 2006, an increase of 66%. The
increase in product revenue is primarily attributable to an 11%
increase in ZYFLO prescription volume, an 11% increase in
ZYFLOs wholesale acquisition price and $2.3 million
in net product sales of ZYFLO CR after its launch in September
2007. In addition, in the first quarter of 2007 Critical
Therapeutics recorded a
250
$953,000 increase in product sales related to the recognition of
revenue from product sales that had been previously deferred,
net of an estimate for remaining product returns.
Revenue under Collaboration and License
Agreements. Critical Therapeutics recognized
collaboration and license revenues of $1.9 million in 2007
compared to $6.4 million in 2006, a decrease of
approximately $4.6 million, or 71%. This decrease was
primarily due to a $5.6 million decrease in collaboration
revenue from Critical Therapeutics collaborations with
MedImmune and Beckman Coulter, offset by $1.0 million in
license revenue related to its agreement with SetPoint. Critical
Therapeutics did not recognize any license revenue from SetPoint
in the year ended December 31, 2006. For 2007, Critical
Therapeutics recognized collaboration revenue of $800,000.
Critical Therapeutics 2007 collaboration revenue also
included:
|
|
|
|
|
$400,000 of previously deferred revenue recognized under its
collaboration agreement with Beckman Coulter for a license fee
paid to advance into formal product development a diagnostic
assay in connection with Critical Therapeutics HMGB1
program;
|
|
|
|
approximately $400,000 related to a portion of the
$12.5 million of initial fees MedImmune paid to Critical
Therapeutics that it recognized over the duration of the
agreement with MedImmune; and
|
|
|
|
the $5.4 million cumulatively billed to MedImmune for
milestone payments and development support from the inception of
the agreement with MedImmune through December 31, 2007.
|
Collaboration revenue for the year ended December 31, 2006
was primarily comprised of the portion of the initial fees
MedImmune paid to Critical Therapeutics that it recognized in
each period, and the portion of milestone payments and
development support billed to MedImmune.
Since it entered into the agreement with MedImmune in 2003,
Critical Therapeutics has billed a total of $17.9 million
to MedImmune, consisting of the $12.5 million initial
payment, a $1.3 million milestone payment and
$4.1 million of development support. As of
December 31, 2007, Critical Therapeutics has recognized
this entire amount as collaboration revenue. At
December 31, 2007, Critical Therapeutics had no deferred
collaboration revenue and had completed the research term of
Critical Therapeutics agreement with MedImmune. Under its
agreement with MedImmune, Critical Therapeutics may receive,
subject to the terms and conditions of the agreement, other
payments upon the achievement of development and
commercialization milestones by MedImmune up to a maximum of
$124.0 million, after taking into account payments that
Critical Therapeutics is obligated to make to The Feinstein
Institute. Critical Therapeutics has not recorded and will not
record these future development and commercialization milestones
until they are achieved. Critical Therapeutics revenue
recognized from existing collaborations in 2008 may decline
substantially because it has now recognized all of the revenue
that it had previously deferred. Going forward, Critical
Therapeutics revenue from collaboration agreements will
fluctuate each quarter and will be highly dependent upon the
achievement of milestones under its existing agreements, or will
be dependent upon its entering into new collaboration agreements.
Costs and
Expenses
Cost of Products Sold. Cost of products sold
in 2007 was $4.2 million, compared to $2.2 million in
2006. Gross margin was 62% for 2007 and 66% for 2006. Cost of
products sold in 2007 consisted of the expenses associated with
manufacturing and distributing ZYFLO and ZYFLO CR, royalties to
Abbott and Jagotec related to ZYFLO and ZYFLO CR and reserves
established for excess or obsolete inventory. As a result of its
change in estimates relating to recognition of ZYFLO sales,
Critical Therapeutics recorded an additional $166,000 in cost of
products sold for 2007. Cost of products sold in 2006 consisted
primarily of the expenses associated with manufacturing and
distributing ZYFLO and royalty payments to Abbott under the
license agreement for ZYFLO. Critical Therapeutics recorded
inventory write-offs of $821,000 for 2007 and $299,000 for 2006.
The write-offs in 2007 and 2006 resulted from excess or obsolete
inventory that could no longer be used for commercial sale.
Research and Development Expenses. Research
and development expenses in 2007 were $21.7 million
compared to $26.9 million in 2006, a decrease of
approximately $5.2 million, or 20%. This decrease was
primarily due to lower expenses associated with clinical trials,
as well as the reduction in the number of
251
employees performing research and development functions
following Critical Therapeutics 2006 restructurings,
offset, in part, by $6.6 million in milestone payments paid
and accrued for during 2007 as a result of the FDAs
approval of the NDA for ZYFLO CR in May 2007.
The following table summarizes the primary components of
Critical Therapeutics research and development expenses
for the years ended December 31, 2007 and 2006:
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
Zileuton (ZYFLO and ZYFLO CR)
|
|
$
|
14,479
|
|
|
$
|
11,975
|
|
Zileuton injection
|
|
|
1,373
|
|
|
|
2,336
|
|
CTI-01
|
|
|
(77
|
)
|
|
|
2,960
|
|
Alpha-7
|
|
|
3,239
|
|
|
|
3,903
|
|
HMGB1
|
|
|
343
|
|
|
|
1,829
|
|
General research and development expenses
|
|
|
1,275
|
|
|
|
2,600
|
|
Stock-based compensation expense
|
|
|
1,023
|
|
|
|
1,309
|
|
|
|
|
|
|
|
|
|
|
Total research and development expenses
|
|
$
|
21,655
|
|
|
$
|
26,912
|
|
|
|
|
|
|
|
|
|
|
The following summarizes the expenses associated with Critical
Therapeutics primary research and development programs:
|
|
|
|
|
Zileuton (ZYFLO and ZYFLO CR). During 2007,
Critical Therapeutics incurred $14.5 million in expenses
related to its orally-dosed zileuton programs, including ZYFLO
and ZYFLO CR, compared to $12.0 million during 2006, a 21%
increase. This increase was primarily due to the following:
|
|
|
|
|
|
$3.1 million in milestone fees paid to third parties as a
result of the FDAs approval of the NDA for ZYFLO CR
in May 2007;
|
|
|
|
$3.5 million in accrued milestone payments to third parties
as a result of the FDAs approval of the NDA for ZYFLO CR
in May 2007, which are due on the first and second year
anniversary of the FDAs approval;
|
|
|
|
$2.2 million increase in clinical and manufacturing costs
related to its Phase IV clinical trial for
ZYFLO CR; and
|
|
|
|
$863,000 increase in clinical and manufacturing costs related to
its R(+) isomer program for zileuton.
|
|
|
|
|
|
The increases in the costs described above were partially offset
by the following:
|
|
|
|
|
|
$2.6 million reduction in clinical and manufacturing costs
for ZYFLO and Critical Therapeutics NDA registration
batches for ZYFLO CR;
|
|
|
|
$1.9 million reduction in milestone fees paid to third
parties as a result of the filing of the ZYFLO CR NDA in July
2006;
|
|
|
|
$1.2 million reduction in operating expenses incurred by
its medical affairs and medical information functions, related
to its scientific support of ZYFLO, as a result of its 2006
restructurings;
|
|
|
|
$1.2 million reduction in salaries, other personnel related
costs and overhead related to its 2006 restructurings; and
|
|
|
|
$305,000 reduction in consulting and scientific advisor fees
related to the ZYFLO CR NDA registration batches.
|
Critical Therapeutics anticipates that its research and
development expenses related to its ZYFLO CR program for 2008
will consist primarily of costs related to its Phase IV
clinical trial for ZYFLO CR, which it discontinued in March 2008.
252
|
|
|
|
|
Zileuton Injection. During 2007, Critical
Therapeutics incurred $1.4 million in expenses related to
its zileuton injection program, compared to $2.3 million
during 2006, a decrease of $963,000, or 41%. This decrease was
primarily due to a reduction in clinical trial expenses related
to its Phase I/II clinical trial, which concluded in the first
half of 2006, offset by costs related to the preparation and
initiation of its Phase II clinical trial in October 2007.
|
|
|
|
CTI-01. During 2007, Critical Therapeutics
received a net credit of $77,000 related to clinical trial costs
associated with its CTI-01 program, compared to expenses of
$3.0 million in 2006. The costs incurred in 2006 related
primarily to the enrollment and conduct of a Phase II
clinical trial of CTI-01 in patients undergoing major cardiac
surgery including the use of a cardiopulmonary bypass machine.
Effective February 2007, Critical Therapeutics terminated its
license agreements with the University of Pittsburgh and Xanthus
Pharmaceuticals related to the development of CTI-01.
|
|
|
|
Alpha-7. During 2007, Critical Therapeutics
incurred $3.2 million in expenses related to its alpha-7
program, compared to $3.9 million during 2006, a 17%
decrease. This decrease was primarily due to a reduction in the
number of employees working on the program following Critical
Therapeutics October 2006 restructuring.
|
|
|
|
HMGB1. During 2007, Critical Therapeutics
incurred $343,000 in expenses related to its HMGB1 program,
compared to $1.8 million during 2006, an 81% decrease. This
decrease was primarily due to lower license fees, sponsored
research and laboratory supplies for Critical Therapeutics
continued testing under its collaboration agreement with
MedImmune, as well as lower personnel costs devoted to this
program.
|
Critical Therapeutics general research and development
expenses, which are not allocated to any specific program, were
$1.3 million in 2007 compared to $2.6 million in 2006,
a decrease of 51%. This decrease was primarily due to improved
methods of allocating Critical Therapeutics research and
development overhead expenses to its various programs, including
costs related to personnel, laboratory and other facility costs
offset, in part, by its impairment of certain laboratory
equipment as a result of its abandoning a substantial portion of
its current facility. Unallocated facility related costs were
$180,000 in 2007, compared to $635,000 in 2006. In addition,
unallocated fixed asset impairment and lease abandonment charges
were $664,000 in 2007. The remaining general research and
development expenses, which are incurred in support of all of
Critical Therapeutics research and development programs,
are not easily allocable to any individual program, and
therefore, have been included in general research and
development expenses.
Stock-based compensation expense that related to research and
development decreased $286,000 from $1.3 million in 2006 to
$1.0 million in 2007. This includes expenses under
SFAS 123(R) for employee grants as well as grants made to
non-employees who are primarily working on research and
development activities. The adjustment to stock-based
compensation expense for non-employees is calculated based on
the change in fair value of Critical Therapeutics common
stock during the period. The decrease in stock-based
compensation expense is related primarily to May 2006 and
October 2006 reductions in Critical Therapeutics research
and development personnel.
Sales and Marketing Expenses. Sales and
marketing expenses for 2007 were $12.2 million, compared to
$18.3 million for 2006. The $6.1 million, or 33%,
decrease in 2007 was primarily attributable to the following:
|
|
|
|
|
a decrease of approximately $4.3 million in salary and
other costs related to the May 2006 and October 2006 reductions
in Critical Therapeutics specialty sales force and sales
and customer management team;
|
|
|
|
a decrease of $1.3 million in employee travel and other
employee expenses following its personnel reductions in 2006;
|
|
|
|
a decrease of $903,000 in infrastructure costs to support the
sales force, including leased vehicle, computer and software
costs;
|
|
|
|
a decrease of $567,000 related to amortization of its deferred
sales and marketing expense;
|
253
|
|
|
|
|
a decrease of $302,000 in severance costs and $525,000 of lower
stock-based compensation expense related to the departure of its
former Senior Vice President of Sales and Marketing in
2006; and
|
|
|
|
a decrease of $222,000 in stock-based compensation expense
primarily related to its employee reductions in 2006.
|
The decreases were offset, in part, by the following:
|
|
|
|
|
an increase of approximately $1.5 million related to
promotional materials, advertising and other costs associated
with the launch of ZYFLO CR that Critical Therapeutics incurred
to support its co-promotion agreement with DEY; and
|
|
|
|
$680,000 in co-promotion fees paid to DEY in accordance Critical
Therapeutics co-promotion agreement.
|
In May and October 2006, Critical Therapeutics reduced the size
of its sales and marketing efforts substantially to bring its
cost structure more in-line with the expected future revenue for
ZYFLO. In connection with these two restructurings, Critical
Therapeutics reduced the size of its sales force promoting ZYFLO
from approximately 80 sales representatives at the beginning of
2006 to 18 sales representatives at December 31, 2006. In
addition, Critical Therapeutics reduced the size of the sales
management team, its customer management, sales operations and
marketing functions. In February 2008, Critical Therapeutics
ceased manufacturing and supplying ZYFLO. In connection with its
launch of ZYFLO CR in September of 2007, Critical Therapeutics
increased its sales force from 18 sales representatives at the
beginning of 2007 to approximately 41 sales representatives at
December 31, 2007.
General and Administrative Expenses. General
and administrative expenses for 2007 were $13.6 million
compared to $13.5 million for 2006. The $116,000, or 1%,
increase in 2007 was primarily attributable to the following:
|
|
|
|
|
an increase of $1.2 million in advisory fees paid in
connection with the upfront and milestones payments that DEY
paid Critical Therapeutics in 2007;
|
|
|
|
an increase of $529,000 in consulting and other expenses
primarily related to its review of strategic alternatives;
|
|
|
|
an increase of $503,000 in legal fees primarily related to its
review of strategic alternatives;
|
|
|
|
an increase of $417,000 related to the additional bonus accrued
at December 31, 2007 in accordance with its agreement with
its then-current President and Chief Executive Officer;
|
|
|
|
an increase of $199,000 in audit and accounting related fees
primarily related to its 2007 filing on
Form S-3,
its co-promotion agreement with DEY and its first 401(k)
audit; and
|
|
|
|
an increase of $196,000 in overhead and facility related charges
as a result of its facility abandonment that are allocated to
general and administrative expenses.
|
The increases were offset, in part, by the following:
|
|
|
|
|
$670,000 of severance costs and $1.3 million of stock-based
compensation expense related to the departure of its former
President and Chief Executive Officer in June 2006;
|
|
|
|
$370,000 related to stock-based compensation as a result of its
May 2006 and October 2006 restructurings; and
|
|
|
|
$351,000 in salary and other related costs as a result of the
May 2006 and October 2006 employee reductions.
|
Restructuring Charges. Restructuring charges
totaled $3.5 million in 2006 related to actions Critical
Therapeutics took in May and October 2006. In May 2006, Critical
Therapeutics recorded charges of $499,000 for a restructuring of
its operations that was intended to better align costs with
revenue and operating expectations. In October 2006, Critical
Therapeutics announced a second restructuring of its operations
to
254
focus its resources on the commercialization of ZYFLO CR and on
the clinical development of zileuton injection and to
significantly reduce its net cash expenditures through lower
spending on its existing sales force as well as on its discovery
and research programs. The restructuring charges for 2006 were
comprised of the following:
|
|
|
|
|
severance, benefit and related payments of approximately
$2.1 million;
|
|
|
|
asset impairment charges of $501,000 related to computer and
laboratory equipment with a net realizable value below its net
book value;
|
|
|
|
stock-based compensation expense of $622,000 related to the
acceleration of vesting of stock options from the departure of
Critical Therapeutics former Senior Vice President of
Research and Development and Chief Scientific Officer; and
|
|
|
|
approximately $335,000 related to the termination of leases on
vehicles used by its sales force and outplacement services.
|
The restructuring charges for 2006 do not include approximately
$972,000 of severance expenses and $1.8 million of
stock-based compensation related to the departures of Critical
Therapeutics former President and Chief Executive Officer
and its former Senior Vice President of Sales and Marketing.
These amounts have been included in general and administrative
expenses and sales and marketing expenses, as described
previously. As of December 31, 2007, Critical Therapeutics
had completed the implementation of these restructurings and
paid all restructuring costs.
Other
Other Income. Interest income in 2007 was
$2.0 million, compared to $2.7 million in 2006. The
decrease was primarily attributable to a lower average cash and
investment balance during 2007. Interest expense amounted to
$209,000 in 2007 and $214,000 in 2006. The interest expense
relates to borrowings under Critical Therapeutics loan
with Silicon Valley Bank for capital expenditures and the
accretion of the discount on its accrued first and second
anniversary milestone payments owed to Abbott and Jagotec as a
result of the FDA approval of the NDA for ZYFLO CR.
Years
Ended December 31, 2006 and 2005
Revenues
Revenue from Product Sales. Critical
Therapeutics recognized revenue from product sales related to
sales of ZYFLO of $6.6 million in 2006 compared to $387,000
in 2005. Product sales in 2005 reflect the period from launch in
October through the end of the year. Under SFAS 48,
Critical Therapeutics recognizes revenue from product shipments
when it has determined the right to return the product has
lapsed or when it can reasonably estimate returns relating to
the shipments to third parties. In accordance with SFAS 48,
in 2005 and 2006, Critical Therapeutics deferred recognition of
revenue on product shipments of ZYFLO to wholesalers,
distributors and pharmacies until the product was dispensed
through patient prescriptions. Shipments of ZYFLO to third
parties that had not been recognized as revenue totaled
$1.2 million as of December 31, 2006 and
$1.7 million as of December 31, 2005 and were included
in deferred product revenue on Critical Therapeutics
balance sheet. Critical Therapeutics deferred the cost of
product shipped to third parties that had not been recognized as
revenue in accordance with its revenue recognition policy until
the product was dispensed through patient prescriptions. This
deferred cost of products sold totaled $167,000 as of
December 31, 2006, compared to $266,000 as of
December 31, 2005, and was included in prepaid expenses and
other current assets on Critical Therapeutics balance
sheet.
Revenue under Collaboration
Agreements. Critical Therapeutics recognized
collaboration revenues of $6.4 million in 2006 compared to
$5.8 million in 2005. These revenues were primarily due to
the portion of the $12.5 million of initial fees MedImmune
paid Critical Therapeutics that Critical Therapeutics recognized
in each period, and the $5.25 million cumulatively billed
to MedImmune for milestone payments and development support from
the inception of the agreement through December 31, 2006.
255
Through December 31, 2006, Critical Therapeutics billed a
total of $17.9 million under its agreement with MedImmune,
consisting of the $12.5 million initial payment, a
$1.3 million milestone payment and $4.1 million of
development support. Critical Therapeutics recognized
$17.5 million of these amounts as collaboration revenue
through December 31, 2006. Critical Therapeutics reported
the balance of the payments, totaling $275,000, as deferred
collaboration revenue and recognized such amount over the
remaining estimated research term of its agreement with
MedImmune based on the proportion of cumulative costs incurred
as a percentage of the total costs estimated for the performance
period. In 2006, Critical Therapeutics revised its cost estimate
to reflect lower than expected costs to be incurred over the
remainder of the contract with MedImmune. The change in estimate
resulted in an increase in revenue recognized of approximately
$2.0 million in 2006. Critical Therapeutics recognized the
balance in deferred revenue during 2007. As of December 31,
2006, Critical Therapeutics also had $400,000 in deferred
collaboration revenue under its collaboration agreement with
Beckman Coulter, which it recognized as collaboration revenue in
the first quarter of 2007.
Costs and
Expenses
Effective January 1, 2006, Critical Therapeutics adopted
the fair value recognition provisions of SFAS 123(R), using
the modified prospective method, which allows it to recognize
compensation cost for shares granted, but unvested, stock
awards, new stock awards and stock awards modified, repurchased,
or cancelled after January 1, 2006. The discussion below is
impacted by the fact that 2005 amounts do not include the impact
of SFAS 123(R).
Cost of Products Sold. Cost of products sold
in 2006 was $2.2 million, compared to $514,000 in 2005.
Cost of products sold consisted primarily of the expenses
associated with manufacturing and distributing ZYFLO and royalty
payments to Abbott under the license agreement for ZYFLO. Cost
of products sold included charges for inventory write-offs of
$299,000 during 2006, compared to $280,000 during 2005. The
write-offs resulted from excess or obsolete inventory that no
longer can be used for commercial sale.
Research and Development Expenses. Research
and development expenses in 2006 were $26.9 million
compared to $30.0 million in 2005, a decrease of
approximately $3.0 million, or 10%. This decrease was
primarily due to lower expenses associated with the technology
transfer and manufacturing activities associated with ZYFLO and
ZYFLO CR, as well as the reduction in the number of employees
performing research and development functions following Critical
Therapeutics May and October 2006 restructurings. With the
commercial launch of ZYFLO in October 2005, the costs of
manufacturing ZYFLO were included in cost of products sold.
The following table summarizes the primary components of
Critical Therapeutics research and development expenses
for the years ended December 31, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2006
|
|
|
2005
|
|
|
|
(In thousands)
|
|
|
Zileuton (ZYFLO and ZYFLO CR)
|
|
$
|
11,975
|
|
|
$
|
12,670
|
|
Zileuton injection
|
|
|
2,336
|
|
|
|
1,656
|
|
CTI-01
|
|
|
2,960
|
|
|
|
3,045
|
|
Alpha-7
|
|
|
3,903
|
|
|
|
2,434
|
|
HMGB1
|
|
|
1,829
|
|
|
|
2,030
|
|
General research and development expenses
|
|
|
2,600
|
|
|
|
7,260
|
|
Stock-based compensation expense
|
|
|
1,309
|
|
|
|
864
|
|
|
|
|
|
|
|
|
|
|
Total research and development expenses
|
|
$
|
26,912
|
|
|
$
|
29,959
|
|
|
|
|
|
|
|
|
|
|
256
The following summarizes the expenses associated with Critical
Therapeutics primary research and development programs:
|
|
|
|
|
Zileuton (ZYFLO and ZYFLO CR). During 2006,
Critical Therapeutics incurred $12.0 million in expenses
related to its orally-dosed zileuton programs, including ZYFLO
and ZYFLO CR, compared to $12.7 million during 2005, a 5%
decrease. This decrease was primarily due to the following:
|
|
|
|
|
|
lower manufacturing costs related to the product registration of
ZYFLO, which was approved for commercial sale in September
2005; and
|
|
|
|
reduced costs related to clinical trials of zileuton in 2006
compared to 2005, when it conducted a Phase II clinical
trial in patients with moderate to severe inflammatory acne.
|
The decreases were offset, in part, by the following:
|
|
|
|
|
completion of certain clinical trials related to the
pharmacokinetic profile of ZYFLO CR in the bloodstream; and
|
|
|
|
initiation of the development of Critical Therapeutics
R(+) isomer program for zileuton.
|
|
|
|
|
|
Zileuton Injection. During 2006, Critical
Therapeutics incurred $2.3 million in expenses related to
its zileuton injection program, compared to $1.7 million
during 2005, a 41% increase. This increase was primarily due to
the completion of a Phase I/II clinical trial of zileuton
injection in 60 patients during 2006 as well as the costs
to manufacture and supply the drug in support of that clinical
trial. During 2005, Critical Therapeutics zileuton
injection program was still in a preclinical stage of development
|
|
|
|
CTI-01. During 2006, Critical Therapeutics
incurred $3.0 million in expenses related to its CTI-01
program, which was comparable to the expenses incurred in 2005.
The costs incurred in both 2006 and 2005 related primarily to
the enrollment and conduct of a Phase II clinical trial of
CTI-01 in patients undergoing major cardiac surgery including
the use of a cardiopulmonary bypass machine. This clinical trial
was initiated in 2005 and completed during 2006. Effective
February 2007, Critical Therapeutics terminated its license
agreement with the University of Pittsburgh related to the
development of CTI-01 and its license agreement with Xanthus
Pharmaceuticals related to the development of CTI-01.
|
|
|
|
Alpha-7. During 2006, Critical Therapeutics
incurred $3.9 million in expenses in connection with
research and development of its alpha-7 program, compared to
$2.4 million during 2005, a 60% increase. The increase was
primarily due to an increase in laboratory supplies and improved
methods of allocating Critical Therapeutics research and
development overhead expenses to its various programs, including
the costs related to facilities, such as its laboratory space,
and the depreciation expense on its laboratory equipment. In
2005, most of these expenses were included in Critical
Therapeutics general research and development expenses.
The number of employees working on alpha-7 during 2006, as
compared to 2005, was relatively consistent through most of the
year leading up to Critical Therapeutics October 2006
restructuring.
|
|
|
|
HMGB1. During 2006, Critical Therapeutics
incurred $1.8 million in expenses for its HMGB1 program,
compared to $2.0 million during 2005, a 10% decrease. This
decrease was primarily due to lower license fees, sponsored
research and laboratory supplies for continued testing under
Critical Therapeutics collaboration agreement with
MedImmune as well as lower personnel costs devoted to this
program. The decreased expenses were partially offset by
increases related to the allocation of Critical
Therapeutics research and development overhead expenses to
its various programs. These overhead expenses include the costs
related to facilities, including Critical Therapeutics
laboratory space, and the depreciation expense on its laboratory
equipment. In 2005, most of these expenses were included in
Critical Therapeutics general research and development
expenses. In addition, Critical Therapeutics paid a
$250,000 milestone payment in 2005 to the licensor of HMGB1
for establishing preclinical proof-of-concept. The collaboration
revenue recognized by Critical Therapeutics in 2006 for this
program totaled $6.4 million. The expenses for HMGB1 are
reflected in the accompanying statements of operations as part
of research and development expenses, while the funding received
from
|
257
|
|
|
|
|
MedImmune and Beckman Coulter to fund Critical
Therapeutics research efforts is included in revenue under
collaboration agreements.
|
Critical Therapeutics general research and development
expenses, which are not allocated to any specific program, were
$2.6 million in 2006 compared to $7.3 million in 2005,
a decrease of 64%. This decrease was primarily due to improved
methods of allocating Critical Therapeutics research and
development overhead expenses to its various programs, including
costs related to personnel, laboratory and other facility costs.
Unallocated facility and related costs were $635,000 in 2006,
compared to $1.7 million in 2005. Unallocated depreciation
expense declined to $59,000 in 2006, compared to $398,000 in
2005. The remaining general research and development expenses,
which are incurred in support of all of Critical
Therapeutics research and development programs, are not
easily allocable to any individual program, and therefore, have
been included in general research and development expenses.
Stock-based compensation expense related to research and
development increased by $445,000 from $864,000 in 2005 to
$1.3 million in 2006. The 2006 amount includes expenses for
employee grants under SFAS 123(R) as well as grants made to
non-employees who were primarily working on research and
development activities. The adjustment to stock-based
compensation expense for non-employees is calculated based on
the change in fair value of Critical Therapeutics common
stock during the period. The increase in stock-based
compensation expense is related primarily to Critical
Therapeutics adoption of SFAS 123(R), offset in part
by the change in the market price of its common stock for
unvested non-employee grants.
Sales and Marketing Expenses. Sales and
marketing expenses for 2006 were $18.3 million, compared to
$13.7 million for 2005. The $4.6 million, or 34%,
increase in 2006 was primarily attributable to the following:
|
|
|
|
|
an increase of approximately $2.2 million in salary costs
related to Critical Therapeutics specialty sales force and
its sales and customer management team, the majority of whom it
hired in August 2005;
|
|
|
|
$513,000 of additional stock-based compensation expense
primarily related to its adoption of SFAS 123(R) and the
increased number of employees during most of 2006;
|
|
|
|
higher infrastructure costs to support the sales force including
leased vehicle, computer and software costs;
|
|
|
|
severance costs of $302,000 and additional stock-based
compensation expense of $525,000 related to the departure of its
former Senior Vice President of Sales and Marketing; and
|
|
|
|
higher product samples, promotional materials and other costs
associated with ZYFLO that it incurred to support its sales
effort.
|
In May and October 2006, Critical Therapeutics reduced the size
of its sales and marketing efforts substantially to bring its
cost structure more in-line with the expected future revenue for
ZYFLO. In connection with these two restructurings, Critical
Therapeutics reduced the size of its sales force promoting ZYFLO
from approximately 80 sales representatives at the beginning of
2006 to 18 sales representatives at December 31, 2006. In
addition, Critical Therapeutics reduced the size of the sales
management team, its customer management, sales operations and
marketing functions for similar reasons.
General and Administrative Expenses. General
and administrative expenses for 2006 were $13.5 million
compared to $11.4 million for 2005. The $2.1 million,
or 18%, increase in 2006 was primarily attributable to the
following:
|
|
|
|
|
severance costs of $670,000 and additional stock-based
compensation expense of $1.3 million related to the
departure of Critical Therapeutics former President and
Chief Executive Officer Dr. Rubin; and
|
|
|
|
$1.7 million of additional stock-based compensation expense
primarily related to its adoption of SFAS 123(R).
|
These increases were offset, in part, by expenses related to
Critical Therapeutics June 2005 private placement, lower
personnel costs related to its May and October 2006
restructurings and a reduction in expenses related to its
compliance with the Sarbanes-Oxley Act.
258
Restructuring Charges. Restructuring charges
totaled $3.5 million in 2006 related to actions Critical
Therapeutics took in May and October 2006. In May 2006, Critical
Therapeutics recorded charges of $499,000 for a restructuring of
its operations that was intended to better align costs with
revenue and operating expectations. In October 2006, Critical
Therapeutics announced a second restructuring of its operations
to focus its resources on the commercialization of ZYFLO CR and
on the clinical development of zileuton injection and to
significantly reduce its net cash expenditures through lower
spending on its existing sales force as well as on its discovery
and research programs. The restructuring charges for 2006 do not
include approximately $972,000 of severance expenses and
$1.8 million of stock-based compensation related to the
departures of Critical Therapeutics President and Chief
Executive Officer and its Senior Vice President of Sales and
Marketing. These amounts have been included in general and
administrative expenses and sales and marketing expenses, as
described above. At December 31, 2006, Critical
Therapeutics had substantially completed the implementation of
these restructurings and approximately $212,000 of accrued
restructuring costs remaining on its balance sheet was paid in
2007.
Other
Other Income. Interest income in 2006 was
$2.7 million, compared to $2.4 million in 2005. The
increase was primarily attributable to higher interest rates and
higher cash and investment balances as a result of the
financings that Critical Therapeutics completed in 2005 and
2006. Interest expense amounted to $214,000 in 2006 and $191,000
in 2005. The interest expense relates to borrowings under
Critical Therapeutics loan with Silicon Valley Bank for
capital expenditures.
Liquidity
and Capital Resources
Sources
of Liquidity
Since its inception on July 14, 2000, Critical Therapeutics
has raised proceeds to fund its operations through public
offerings and private placements of equity securities, debt
financings, the receipt of interest income, payments from its
collaboration, license and co-promotion agreements, the exercise
of stock options, and revenues from sales of ZYFLO and ZYFLO CR.
As of June 30, 2008, Critical Therapeutics had
$11.2 million in cash, cash equivalents and investments.
Critical Therapeutics has invested its cash and cash equivalents
primarily in highly liquid, interest-bearing, investment grade
securities in accordance with its established corporate
investment policy.
In July 2003, Critical Therapeutics entered into an
exclusive license and collaboration agreement with MedImmune for
the discovery and development of novel drugs for the treatment
of acute and chronic inflammatory diseases associated with
HMGB1, a newly discovered cytokine. Under this collaboration,
MedImmune paid Critical Therapeutics initial fees of
$12.5 million and an additional $5.4 million through
June 30, 2008 for milestone payments and to fund certain
research expenses incurred by Critical Therapeutics for the
HMGB1 program. As of June 30, 2008, Critical Therapeutics
had completed the research portion of its agreement with
MedImmune and will not conduct any future research or
development activities under this agreement.
Under its collaboration with MedImmune, Critical Therapeutics
may receive additional payments upon the achievement of
research, development and commercialization milestones up to a
maximum of $124.0 million, after taking into account
payments it is obligated to make to The Feinstein Institute on
milestone payments it receives from MedImmune.
Under its co-promotion agreement with DEY, Critical Therapeutics
received a non-refundable upfront payment of $3.0 million
in March 2007, a milestone payment of $4.0 million in June
2007 following approval by the FDA of the NDA for ZYFLO CR in
May 2007 and a milestone payment of $5.0 million in
December 2007 following the commercial launch of ZYFLO CR.
Cash
Flow
Operating Activities. Net cash used in
operating activities was $23.2 million for the six months
ended June 30, 2008, compared to $8.5 million for the
six months ended June 30, 2007, an increase of
$14.7 million,
259
or 172%. Net cash used in operations for the six months ended
June 30, 2008 consisted of a net loss of
$17.4 million, depreciation and amortization expense, the
amortization of premiums on short-term investments, the loss on
the disposal of fixed assets and impairment charge on fixed
assets of $601,000, stock-based compensation expense of
$1.5 million and a $7.9 million decrease as a result
of changes in the working capital accounts. This
$7.9 million decrease was primarily due to a
$2.2 million increase in inventory, a $1.9 million
decrease in accrued license fees and a $2.8 million
reduction in its accounts payable and accrued expenses.
Investing Activities. Investing
activities provided $677,000 of net cash in the six months ended
June 30, 2008, compared to $212,000 in the six months ended
June 30, 2007. During the six months ended June 30,
2008, Critical Therapeutics made minimal capital expenditures.
Net cash provided by investing activities for the six months
ended June 30, 2008 primarily related to proceeds from
Critical Therapeutics sale of assets of $278,000 and its
sale of its SetPoint stock for $400,000. In addition, as
interest rates have gradually decreased, Critical Therapeutics
has maintained more of its investments as cash equivalents
rather than short-term investments.
Financing Activities. In the six months
ended June 30, 2008, Critical Therapeutics used $370,000 of
net cash in financing activities, compared to $261,000 in the
six months ended June 30, 2007. Net cash used in financing
activities for the six months ended June 30, 2008 primarily
related to the repayment of long-term debt.
Income
Taxes
Critical Therapeutics has accumulated net operating losses and
tax credits available to offset future taxable income for
federal and state income tax purposes as of June 30, 2008.
If not utilized, federal net operating loss carryforwards will
begin to expire in 2021. State net operating loss carryforwards
began to expire in 2006. The federal tax credits expire
beginning in 2021. To date, Critical Therapeutics has not
recognized the potential tax benefit of its net operating loss
carryforwards or credits on its balance sheet or statements of
operations. The future utilization of Critical
Therapeutics net operating loss carryforwards may be
limited based upon changes in ownership pursuant to regulations
promulgated under the Internal Revenue Code.
Funding
Requirements and Going Concern
Critical Therapeutics has experienced significant operating
losses in each year since its inception in 2000. Critical
Therapeutics had net losses of $37.0 million in the year
ended December 31, 2007 and $48.8 million in the year
ended December 31, 2006. Critical Therapeutics had net
losses of $17.4 million in the six months ended
June 30, 2008 and $17.6 million in the six months
ended June 30, 2007. As of June 30, 2008, Critical
Therapeutics had an accumulated deficit of approximately
$209 million. Critical Therapeutics expects that it will
continue to incur substantial losses for the foreseeable future
as it spends significant amounts to fund its development and
commercialization efforts. As a result, there is substantial
doubt about Critical Therapeutics ability to continue as a
going concern. Critical Therapeutics ability to continue
as a going concern will require it to obtain additional
financing to fund its operations. Critical Therapeutics has
prepared its financial statements on the assumption that it will
continue as a going concern, which contemplates the realization
of assets and discharge of liabilities in the normal course of
business. Doubt about Critical Therapeutics ability to
continue as a going concern may make it more difficult to obtain
financing for the continuation of operations and could result in
the loss of confidence by investors, creditors, suppliers and
employees.
Critical Therapeutics expects to devote substantial resources to
support the marketing of ZYFLO CR and to fund the development of
its product candidates. Critical Therapeutics has not made, and
does not expect to make, a significant investment in capital
expenditures in 2008. Critical Therapeutics expects to fund any
capital expenditures through cash received from product sales
and interest income from invested cash and cash equivalents and
short-term investments. Critical Therapeutics funding
requirements will depend on numerous factors, including:
|
|
|
|
|
the ongoing costs of the sales and marketing of ZYFLO CR;
|
|
|
|
the amount and timing of sales and returns of ZYFLO CR and ZYFLO;
|
260
|
|
|
|
|
the costs of ongoing manufacturing activities for ZYFLO CR and
ZYFLO;
|
|
|
|
the time and costs involved in preparing, submitting, obtaining
and maintaining regulatory approvals for Critical
Therapeutics other product candidates;
|
|
|
|
the timing, receipt and amount of milestone and other payments,
if any, from DEY, MedImmune, Beckman Coulter, SetPoint or
future collaborators or licensees;
|
|
|
|
the timing, receipt and amount of sales and royalties, if any,
from Critical Therapeutics product candidates;
|
|
|
|
continued progress in Critical Therapeutics research and
development programs, as well as the magnitude of these
programs, including milestone payments to third parties under
Critical Therapeutics license agreements;
|
|
|
|
the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims;
|
|
|
|
the cost of obtaining and maintaining licenses to use patented
technologies;
|
|
|
|
potential acquisition or in-licensing of other products or
technologies;
|
|
|
|
Critical Therapeutics ability to establish and maintain
additional collaborative or co-promotion arrangements; and
|
|
|
|
the ongoing time and costs involved in corporate governance
requirements, including work related to compliance with the
Sarbanes-Oxley Act.
|
Other than payments that Critical Therapeutics may receive from
its collaborations with MedImmune and Beckman Coulter, sales of
ZYFLO CR and ZYFLO represent Critical Therapeutics only
sources of cash flows and revenue. In addition to the foregoing
factors, Critical Therapeutics believes that its ability to
access external funds will depend upon market acceptance of
ZYFLO CR, the success of its other preclinical and clinical
development programs, the receptivity of the capital markets to
financings by biopharmaceutical companies, its ability to enter
into additional strategic collaborations with corporate and
academic collaborators and the success of such collaborations.
The extent of Critical Therapeutics future capital
requirements is difficult to assess and will depend largely on
its ability to successfully manufacture and commercialize ZYFLO
CR. Based on its operating plans, Critical Therapeutics believes
that its available cash and cash equivalents and anticipated
cash received from product sales will be sufficient to fund
anticipated levels of operations into the first quarter of 2009.
For the six months ended June 30, 2008, Critical
Therapeutics net cash used for operating activities was
$23.2 million, and Critical Therapeutics had minimal
capital expenditures. If Critical Therapeutics existing
resources are insufficient to satisfy its liquidity requirements
or if Critical Therapeutics acquires or licenses rights to
additional product candidates, it may need to raise additional
external funds through collaborative arrangements and public or
private financings. Under Critical Therapeutics merger
agreement with Cornerstone, any financing transaction would
require Cornerstones consent. Additional financing may not
be available to Critical Therapeutics on acceptable terms or at
all. In addition, the terms of the financing may adversely
affect the holdings or the rights of Critical Therapeutics
stockholders. For example, if Critical Therapeutics raises
additional funds by issuing equity securities, further dilution
to Critical Therapeutics then-existing stockholders will
result. Such equity securities may have rights and preferences
superior to those of the holders of Critical Therapeutics
common stock. If Critical Therapeutics is unable to obtain
funding on a timely basis, Critical Therapeutics may be required
to significantly delay, limit or eliminate one or more of its
development or commercialization programs, which could harm its
financial condition and operating results. Critical Therapeutics
also could be required to seek funds through arrangements with
collaborators or others that may require
Critical Therapeutics to relinquish rights to some of its
technologies, product candidates or products, which
Critical Therapeutics would otherwise pursue on its own.
261
Contractual
Obligations
Critical Therapeutics has summarized in the table below its
fixed contractual obligations as of June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
Less Than
|
|
|
One to
|
|
|
Three to
|
|
|
More Than
|
|
Contractual Obligations
|
|
Total
|
|
|
One Year
|
|
|
Three Years
|
|
|
Five Years
|
|
|
Five Years
|
|
|
|
(In thousands)
|
|
|
Manufacturing and clinical trial agreements
|
|
$
|
16,002
|
|
|
$
|
9,087
|
|
|
$
|
6,907
|
|
|
$
|
8
|
|
|
$
|
|
|
Research and license agreements
|
|
|
10,030
|
|
|
|
3,925
|
|
|
|
825
|
|
|
|
920
|
|
|
|
4,360
|
|
Marketing costs
|
|
|
6,737
|
|
|
|
2,237
|
|
|
|
4,500
|
|
|
|
|
|
|
|
|
|
Severance agreements
|
|
|
892
|
|
|
|
892
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lease obligations
|
|
|
277
|
|
|
|
277
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consulting agreement
|
|
|
36
|
|
|
|
36
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations
|
|
$
|
33,974
|
|
|
$
|
16,454
|
|
|
$
|
12,232
|
|
|
$
|
928
|
|
|
$
|
4,360
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The amounts listed for manufacturing and clinical trial
agreements represent amounts due to third parties for
manufacturing, clinical trials and preclinical studies. On
August 20, 2007, Critical Therapeutics entered into an
agreement with Jagotec, under which Jagotec agreed to
manufacture and supply bulk ZYFLO CR tablet cores for commercial
sale. Critical Therapeutics has agreed to purchase minimum
quantities of ZYFLO CR tablet cores during each
12-month
period for the first five years following marketing approval of
ZYFLO CR by the FDA. Critical Therapeutics has committed to
purchase a minimum of 20 million ZYFLO CR tablet cores from
Jagotec in each of the four
12-month
periods starting May 30, 2008. For the term of the
contract, Critical Therapeutics has agreed to purchase specified
amounts of its requirements for ZYFLO CR from Jagotec. The
commercial manufacturing agreement has an initial term of five
years beginning on May 22, 2007, and will automatically
continue thereafter, unless Critical Therapeutics provides
Jagotec with
24-months
prior written notice of termination or Jagotec provides Critical
Therapeutics with
36-months
prior written notice of termination. In addition, Critical
Therapeutics has the right to terminate the agreement upon
30-days
prior written notice in the event any governmental agency takes
any action, or raises any objection, that prevents it from
importing, exporting or selling ZYFLO CR. Critical Therapeutics
also may terminate the agreement upon six-months advance
notice in the event that an AB-rated generic pharmaceutical
product containing zileuton is introduced in the United States
and it determines to permanently cease commercialization of
ZYFLO CR. Likewise, Critical Therapeutics may terminate the
agreement upon
12-months
advance notice if it intends to discontinue commercializing
ZYFLO CR tablets. Furthermore, each party has the right to
terminate the agreement upon the occurrence of a material
uncured breach by the other party. In the event either party
terminates the agreement, Critical Therapeutics has agreed to
purchase quantities of ZYFLO CR tablets that are subject to
binding forecasts.
In addition, Critical Therapeutics entered into a manufacturing
and supply agreement with Shasun Pharma Solutions Ltd., or
Shasun, for commercial production of zileuton API, subject to
specified limitations, through December 31, 2009. Under
this agreement, Critical Therapeutics has agreed to purchase
specified quantities of API in 2008 and 2009 with a portion
subject to the right of cancellation. The API purchased from
Shasun currently has a minimum shelf-life of 36 months.
The amounts listed for research and license agreements represent
Critical Therapeutics fixed obligations payable to sponsor
research and minimum royalty payments and milestone payments for
licensed patents. These amounts do not include any additional
amounts that Critical Therapeutics may be required to pay under
its license agreements upon the achievement of scientific,
regulatory and commercial milestones that may become payable
depending on the progress of scientific development and
regulatory approvals, including milestones such as the
submission of an IND to the FDA, similar submissions to foreign
regulatory authorities and the first commercial sale of Critical
Therapeutics products in various countries.
Critical Therapeutics is party to a number of agreements that
require it to make milestone payments. In particular, under
Critical Therapeutics license agreement with Abbott for
zileuton, it agreed to make aggregate milestone payments of up
to $13.0 million to Abbott upon the achievement of various
development
262
and commercialization milestones relating to zileuton, including
the completion of the technology transfer from Abbott to
Critical Therapeutics, filing and approval of a product in the
United States and specified minimum net sales of licensed
products. Through June 30, 2008, Critical Therapeutics has
made aggregate milestone payments of $7.8 million to Abbott
under its license agreements related to ZYFLO and ZYFLO CR and,
as of June 30, 2008, has included $1.5 million in
accounts payable related to the achievement of the first
anniversary milestone. In addition, under its license agreement
with Jagotec, through its subsidiary Jagotec, for ZYFLO CR,
Critical Therapeutics agreed to make aggregate milestone
payments of up to $6.6 million upon the achievement of
various development and commercialization milestones. Through
June 30, 2008, Critical Therapeutics has made aggregate
milestone payments of $3.0 million to Jagotec under its
agreement and, as of June 30, 2008, has included $375,000
in accounts payable related to the achievement of the first
anniversary milestone. In May 2007, Critical Therapeutics
received FDA approval of the NDA for ZYFLO CR. Included in the
amounts listed for research and license agreements are the
combined first and second anniversary milestone payments related
to the FDAs approval of ZYFLO CR due to Abbott and Jagotec
totaling $3.8 million.
The amounts listed for marketing costs represent advertising and
promotional commitments under Critical Therapeutics
co-promotion agreement with DEY related to its marketing support
for ZYFLO CR.
The amounts listed for lease obligations represent the amounts
Critical Therapeutics owes under its facility, computer and
vehicle lease agreements under both operating and capital leases.
The amounts listed for consulting agreements are for fixed
payments due to Critical Therapeutics scientific and
business consultants.
The amounts shown in the table do not include royalties on net
sales of Critical Therapeutics products and payments on
sublicense income that it may owe as a result of receiving
payments under its collaboration or license agreements.
The amounts listed for research and license agreements,
consulting agreements and manufacturing and clinical trial
agreements include amounts that Critical Therapeutics owes under
agreements that are subject to cancellation or termination by it
under various circumstances, including a material uncured breach
by the other party, minimum notice to the other party or payment
of a termination fee.
The amounts listed in the table above do not include payment of
a termination fee of $1.0 million or the reimbursement of
expenses of up to $150,000 that Critical Therapeutics could be
obligated to pay to Cornerstone in specified circumstances in
connection with the termination of the merger agreement with
Cornerstone.
Critical Therapeutics evaluates the need to provide reserves for
contractually committed future purchases of inventory that may
be in excess of forecasted future demand. In making these
assessments, Critical Therapeutics is required to make judgments
as to the future demand for current or committed inventory
levels and as to the expiration dates of its products. While
Critical Therapeutics purchase commitment for API from
Shasun exceeds its current forecasted demand in 2008, Critical
Therapeutics expects that any excess API purchased in 2008 and
2009 under its agreement with Shasun will be used in commercial
production batches in 2008, 2009 and 2010 and sold before it
requires retesting. Therefore, no reserve for this purchase
commitment has been recorded as of June 30, 2008.
Effects
of Inflation
A substantial portion of Critical Therapeutics assets are
monetary, consisting primarily of cash, cash equivalents and
investments. Because of their liquidity, these assets are not
significantly affected by inflation. Critical Therapeutics also
believes that it has intangible assets in the value of its
technology. In accordance with generally accepted accounting
principles, Critical Therapeutics has not capitalized the value
of this intellectual property on its consolidated balance sheet.
Because Critical Therapeutics intends to retain and continue to
use its equipment, furniture and fixtures and leasehold
improvements, it believes that the incremental inflation related
to the replacement costs of such items will not materially
affect its operations. However, the rate of inflation affects
its expenses, such as those for employee compensation and
contract
263
services, which could increase Critical Therapeutics level
of expenses and the rate at which it uses its resources.
Recent
Accounting Pronouncements
In November 2007, the EITF issued EITF Issue
No. 07-01,
Accounting for Collaborative Arrangements, or
EITF 07-01.
EITF 07-01
requires collaborators to present the results of activities for
which they act as the principal on a gross basis and report any
payments received from or made to other collaborators based on
other applicable generally accepted accounting principles or, in
the absence of other applicable generally accepted accounting
principles, based on analogy to authoritative accounting
literature or a reasonable, rational and consistently applied
accounting policy election. Further,
EITF 07-01
clarified that the determination of whether transactions within
a collaborative arrangement are part of a vendor-customer or
analogous relationship subject to EITF Issue
No. 01-9,
Accounting for Consideration Given by a Vendor to a
Customer.
EITF 07-01
is effective for fiscal years beginning after December 15,
2008. Critical Therapeutics does not expect the adoption of
EITF 07-01
to have a material impact on its financial statements and
results of operations.
In June 2007, the EITF issued EITF Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development
Activities, or
EITF 07-3.
EITF 07-3
concludes that non-refundable advance payments for future
research and development activities should be deferred and
capitalized until the goods have been delivered or the related
services have been performed. If an entity does not expect the
goods to be delivered or the services to be rendered, the
capitalized advance payment should be charged to expense.
EITF 07-3
is effective for fiscal years beginning after December 15,
2007. The initial adjustment to reflect the effect of applying
this EITF as a change in accounting principle would be accounted
for as a cumulative-effect adjustment to retained earnings as of
the beginning of the year of adoption. The adoption of
EITF 07-03
did not have a material impact on Critical Therapeutics
financial statements and results of operations.
In May 2008, the FASB issued SFAS No. 162, The
Hierarchy of Generally Accepted
Accounting Principles, or SFAS 162.
SFAS 162 identifies the sources of accounting principles
and the framework for selecting the principles to be used in the
preparation of financial statements of nongovernmental entities
that are presented in conformity with GAAP, or the GAAP
hierarchy. SFAS 162 makes the GAAP hierarchy explicitly and
directly applicable to preparers of financial statements, a step
that recognizes preparers responsibilities for selecting
the accounting principles for their financial statements, and
sets the stage for making the framework of the FASB Concept
Statements fully authoritative. The effective date for
SFAS 162 is 60 days following the SECs approval
of the Public Company Accounting Oversight Boards related
amendments to remove the GAAP hierarchy from auditing standards,
where it has resided for some time. Critical Therapeutics does
not expect the adoption of SFAS 162 to have a material
impact on its financial statements and results of operations.
In April 2008, the FASB issued FASB Staff Position Financial
Accounting Standard
142-3,
Determination of the Useful
Life of Intangible Assets, or FSP
FAS 142-3.
FSP
FAS 142-3
amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful
life of a recognized intangible asset under SFAS 142,
Goodwill and Other Intangible
Assets. In developing assumptions about renewal or
extension, FSP
FAS 142-3
requires an entity to consider its own historical experience or,
if it has no experience, market participant assumptions,
adjusted for the entity-specific factors in paragraph 11 of
SFAS 142. FSP
FAS 142-3
expands the disclosure requirements of SFAS 142 and is
effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods
within those fiscal years, with early adoption prohibited. The
guidance for determining the useful life of a recognized
intangible asset must be applied prospectively to intangible
assets acquired after the effective date. The disclosure
requirements must be applied prospectively to all intangible
assets recognized as of, and subsequent to, the effective date.
Critical Therapeutics does not expect the adoption of FSP
FAS 142-3
to have a material impact on its financial statements and
results of operations.
264
In December 2007, the FASB issued SFAS No. 141(R),
Business Combinations, or SFAS 141(R).
SFAS 141(R) requires the acquiring entity in a business
combination to record all assets acquired and liabilities
assumed at their respective acquisition-date fair values and
changes other practices under SFAS No. 141,
Business Combinations, some of which could have a
material impact on how an entity accounts for its business
combinations. SFAS 141(R) also requires additional
disclosure of information surrounding a business combination,
such that users of the entitys financial statements can
fully understand the nature and financial impact of the business
combination. SFAS 141(R) is effective for fiscal years
beginning after December 15, 2008 and is applied
prospectively to business combinations for which the acquisition
date is on or after January 1, 2009. The provisions of
SFAS 141(R) will only impact Critical Therapeutics if it is
a party to a business combination after the pronouncement has
been adopted.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interest in Consolidated Financial
Statements an amendment of ARB No. 51, or
SFAS 160. SFAS 160 requires entities to report
non-controlling minority interests in subsidiaries as equity in
consolidated financial statements. SFAS 160 is effective
for fiscal years beginning on or after December 15, 2008.
SFAS 160 is applied prospectively as of the beginning of
the fiscal year in which it is initially applied, except for
presentation and disclosure requirements, which are applied
retrospectively for all periods presented. Critical Therapeutics
does not expect the adoption of SFAS 160 to have a material
impact on its financial statements and results of operations.
In February 2007, the FASB issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial
Liabilities, Including an Amendment of SFAS 115, or
SFAS 159. SFAS 159 permits companies to choose to
measure many financial instruments and certain other items at
fair value. It also establishes presentation and disclosure
requirements designed to facilitate comparisons between
companies that choose different measurement attributes for
similar types of assets and liabilities. SFAS 159 requires
companies to provide additional information that will help
investors and other users of financial statements to more easily
understand the effect of a companys choice to use fair
value on its earnings. It also requires entities to display the
fair value of those assets and liabilities for which a company
has chosen to use fair value on the face of the balance sheet.
SFAS 159 is effective for fiscal years beginning after
November 15, 2007 and interim periods within those fiscal
years. Critical Therapeutics was required to adopt SFAS 159
on January 1, 2008. The adoption of SFAS 159 did not
have a material impact on Critical Therapeutics financial
statements and results of operations, as it elected not to
measure any financial assets or liabilities at fair value.
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements, or SFAS 157. SFAS 157
defines fair value, establishes a framework for measuring fair
value in generally accepted accounting principles and expands
disclosures about fair value measurements. In February 2008, the
FASB issued Staff Position
No. FAS 157-2,
or
FSP 157-2,
that defers the effective date of applying the provisions of
SFAS 157 to the fair value measurement of nonfinancial
assets and nonfinancial liabilities until fiscal years beginning
after November 15, 2008. Critical Therapeutics was required
to adopt the provisions of SFAS 157 that pertain to
financial assets and liabilities on January 1, 2008.
Critical Therapeutics is currently evaluating the effect
FSP 157-2
will have on its financial statements and results of operations.
265
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT
CRITICAL THERAPEUTICS MARKET RISK
Critical Therapeutics is exposed to market risk related to
changes in interest rates. Critical Therapeutics current
investment policy is to maintain an investment portfolio
consisting of U.S. government treasury and agency notes,
corporate debt obligations, municipal debt obligations, auction
rate securities and money market funds, directly or through
managed funds, with maturities of two years or less. Critical
Therapeutics cash is deposited in and invested through
highly rated financial institutions in North America. Critical
Therapeutics investments are subject to interest rate risk
and will fall in value if market interest rates increase. If
market interest rates were to increase immediately and uniformly
by 10% from levels at June 30, 2008, Critical Therapeutics
estimates that the fair value of its investment portfolio would
not change by a material amount. Critical Therapeutics could be
exposed to losses related to these securities should one of its
counterparties default. Critical Therapeutics attempts to
mitigate this risk through credit monitoring procedures.
Critical Therapeutics has the ability to hold its fixed income
investments until maturity, and therefore Critical Therapeutics
would not expect its operating results or cash flows to be
affected to any significant degree by the effect of a change in
market interest rates on its investments. At June 30, 2008,
Critical Therapeutics held approximately $284,000 in an auction
rate security with a AAA credit rating upon purchase. In
February 2008, Critical Therapeutics was informed that there was
insufficient demand at auction for this security. As a result,
this amount is currently not liquid and may not become liquid
unless the issuer is able to refinance it. Critical Therapeutics
has classified its investment in the auction rate security as a
long-term investment and included the investment in other assets
on its balance sheet.
266
CORNERSTONES
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of
Cornerstones financial condition and results of operations
together with the Selected Historical Consolidated
Financial Data of Cornerstone section of this proxy
statement/prospectus and Cornerstones financial statements
and accompanying notes included in this proxy
statement/prospectus. In addition to historical information, the
following discussion contains forward-looking statements that
involve risks, uncertainties and assumptions. Cornerstones
actual results may differ materially from those anticipated in
these forward-looking statements as a result of many important
factors, including, but not limited to, those set forth in the
Risks Related to Cornerstone section of this proxy
statement/prospectus.
Overview
Cornerstone is a specialty pharmaceutical company focused on
acquiring, developing and commercializing prescription products
for the respiratory market. Cornerstones commercial
strategy is to acquire non-promoted or underperforming branded
pharmaceutical products and then maximize their potential value
by promoting the products using its sales and marketing
capabilities and applying various product life cycle management
techniques.
Since its inception in 2004, Cornerstone has acquired or
licensed the rights to seven marketed product lines. Cornerstone
began to market its first product in 2004. As of
September 15, 2008, Cornerstone promoted two product lines
with four marketed products in the United States to
respiratory-focused physicians and key retail pharmacies with
its 49 person specialty sales force. Cornerstone also
generates revenues from product sales and royalties from the
sale of seven marketed product lines that include products that
it does not promote. Two of these seven product lines include
products that are promoted by third parties, and six include
products that are not promoted by Cornerstone or any third
party. Four of these six product lines include generic products
that Cornerstone markets through its Aristos subsidiary.
Key
Marketed Products
Cornerstone currently promotes SPECTRACEF and the ALLERX Dose
Pack family of products. In addition, Cornerstone has entered
into co-promotion agreements with SJ Pharmaceuticals for the
co-promotion of these products. Under these agreements,
Cornerstone pays royalties to SJ Pharmaceuticals equal to a
percentage of the net profits on Cornerstones sales of
these products above a specified baseline based on prescriptions
by assigned, targeted prescribers within assigned sales
territories.
SPECTRACEF. SPECTRACEF is a third generation
cephalosporin with the API cefditoren pivoxil. SPECTRACEF is
indicated for the treatment of mild to moderate infections
caused by pathogens associated with particular respiratory tract
infections. In October 2006, Cornerstone acquired from Meiji the
exclusive U.S. rights to manufacture and sell SPECTRACEF
and additional cefditoren pivoxil products and to use the
SPECTRACEF trademark from Meiji pursuant to a license and supply
agreement, as amended and supplemented. In exchange for these
exclusive U.S. rights, Cornerstone agreed to pay Meiji a
$6.0 million non-refundable license fee in installments
over five years and quarterly royalties based on the net sales
of the cefditoren pivoxil products covered by the agreement.
Cornerstone paid $250,000 of the license fee in 2006 and
$1.0 million in 2007. Additional installments of the
license fee are due and payable as follows: $1.0 million in
October 2008, $1.0 million in October 2009,
$1.25 million in October 2010 and $1.5 million in
October 2011. Cornerstone is also required to purchase annual
minimum quantities of cefditoren pivoxil from Meiji during the
first five years of the agreement.
ALLERX Dose Pack Products. Cornerstone
currently markets three ALLERX Dose Pack products, each in
10-day and
30-day
regimens:
|
|
|
ALLERX 10 Dose Pack and ALLERX 30 Dose Pack, both of which
Cornerstone began marketing in February 2008;
|
267
|
|
|
ALLERX Dose Pack DF and ALLERX Dose Pack DF 30, which
Cornerstone began marketing in August 2006 and July 2007,
respectively; and
|
|
|
ALLERX Dose Pack PE and ALLERX Dose Pack PE 30, which
Cornerstone began marketing in September 2006 and October 2007,
respectively.
|
Each of these products is administered orally and is indicated
for the temporary relief of symptoms associated with allergic
rhinitis. In February 2005, Cornerstone acquired all of the
rights to the ALLERX products held by Adams in exchange for
Cornerstones rights to the Humibid family of products.
Cornerstone began marketing the first of its ALLERX Dose Pack
products in February 2005, which it has replaced with
ALLERX 10 Dose Pack and ALLERX 30 Dose Pack. Cornerstone
believes that ALLERX 10 Dose Pack, ALLERX 30 Dose Pack,
ALLERX Dose Pack PE and ALLERX Dose Pack PE 30 are protected
under claims in the 372 Patent, which Cornerstone licensed
directly from Pharmaceutical Innovations, in August 2006. Under
its license agreement with Pharmaceutical Innovations, as
amended, Cornerstone pays Pharmaceutical Innovations royalties
based on a percentage of the net sales per calendar year of each
product, subject to specified minimums.
Other
Products
Cornerstone currently generates revenues from product sales and
royalties from the sale of seven marketed product lines that
include products that it does not actively promote. Two of these
seven product lines are promoted by third parties, and six
include products that are not currently promoted by Cornerstone
or any third party. Cornerstones other products that have
generated the most net revenues to date are the BALACET 325,
APAP 500 and DECONSAL products.
BALACET 325, APAP 325 and APAP 500. BALACET
325, APAP 325 and APAP 500 are indicated for the relief of mild
to moderate pain. In July 2004, Cornerstone licensed the rights
to these products from Vintage for an upfront payment of
$5.0 million, a note payable of $3.0 million and
ongoing quarterly royalty payments equal to a percentage of the
products net sales. Cornerstone paid the note payable in
full in February 2006. Cornerstone began marketing
BALACET 325 in April 2005, but ceased all marketing efforts
for this product in January 2007 to concentrate its resources on
the respiratory market. In July 2008, Cornerstone began
marketing APAP 325 through its Aristos subsidiary as a
generic formulation of BALACET 325.
In September 2005, Cornerstone entered into a supply and
marketing agreement with Pliva relating to APAP 500. Under this
agreement, Pliva sells APAP 500 that is supplied to it by
Vintage and pays Cornerstone royalties based on the quarterly
net sales of APAP 500. Cornerstones agreement with Pliva
will terminate on December 31, 2008, at which time
Cornerstone expects that it will begin marketing APAP 500
through its Aristos subsidiary.
In April 2007, Cornerstone entered into a co-promotion agreement
with Atley Pharmaceuticals to co-promote BALACET 325. Under the
agreement, Cornerstone pays Atley Pharmaceuticals co-promotion
fees based on a percentage of the net profits from
Cornerstones sales of BALACET 325, and any generic
formulations thereof marketed by Cornerstone, above a specified
baseline based on prescriptions by all prescribers within
assigned sales territories.
DECONSAL. In July 2004, Cornerstone acquired
all rights related to prescription products marketed under the
DECONSAL brand name from Carolina Pharmaceuticals in exchange
for quarterly royalties equal to a percentage of the net sales
of DECONSAL products through December 31, 2006. In January
2005, Cornerstone launched DECONSAL II, an expectorant and nasal
decongestant combination tablet for oral administration with the
APIs guaifenesin and phenylephrine. In 2006, Cornerstone
launched the DECONSAL CT Tannate Chewable Tablets and DECONSAL
DM Tannate Chewable Tablets, which contain an antihistamine, a
nasal decongestant and, with respect to DECONSAL DM, an
antitussive. In May 2007, the FDA announced that manufacturers
must stop making products that contain guaifenesin in a timed
release dosage form by August 27, 2007 and stop shipping in
interstate commerce by November 25, 2007. As a result,
Cornerstone stopped selling DECONSAL II in November 2007.
268
HYOMAX. The HYOMAX line of products consists
of generic formulations of four antispasmodic medications
containing the API hyoscyamine sulfate, an anticholinergic,
which may be prescribed for various gastrointestinal disorders.
Aristos launched the first HYOMAX product, HYOMAX SL
0.125 mg tablets, in May 2008, followed by HYOMAX SR
0.375 mg tablets and HYOMAX FT 0.125 mg chewable melt
tablets in June 2008 and HYOMAX DT 0.125 mg immediate
release/0.25 mg sustained release biphasic tablets in
July 2008. In exchange for using commercially reasonable
efforts to market the HYOMAX line of products to wholesalers and
distributors in the United States, Cornerstone receives a share
of the net profits realized from the sale of these products.
ALLERX and RESPIVENT. In addition to
Cornerstones ALLERX Dose Pack family of products,
Cornerstone also markets ALLERX-D, which provides relief of the
symptoms of allergic rhinitis without an antihistamine, and
ALLERX Suspension, which is an oral, liquid decongestant and
antihistamine combination. Cornerstone also markets two
RESPIVENT products, RESPIVENT-D and RESPIVENT DF Dose Pack,
which it launched in July 2008. RESPIVENT-D is a generic
formulation of ALLERX-D. RESPIVENT DF Dose Pack is a generic
formulation of ALLERX Dose Pack DF, which, like ALLERX Dose Pack
DF, is available in
ten-day and
30-day
dosing regimens.
Extendryl®. In
January 2005, Cornerstone acquired the Extendryl family of
respiratory medication products through a sublicense agreement
with Tryon Laboratories, Inc. These prescription products are
indicated for the relief of respiratory congestion, allergic
rhinitis and vasomotor rhinitis. Cornerstones sales force
promoted the Extendryl products until May 2005. At that time,
Cornerstone granted Auriga Laboratories, Inc., or Auriga, an
exclusive sublicense to market the Extendryl products in
exchange for royalties on Aurigas net sales of Extendryl.
Auriga and Cornerstone amended the license agreement in
September 2006 to include Extendryl line extensions and lower
the royalty rate owed to Cornerstone in exchange for the
issuance of 200,000 shares of Auriga common stock to
Cornerstone.
Product
Candidates
Cornerstones product development pipeline includes three
SPECTRACEF line extensions, a methscopolamine and antihistamine
combination product candidate and two hydrocodone cough
suppressant candidates. The SPECTRACEF line extensions include:
|
|
|
SPECTRACEF 400 mg, a single 400 mg tablet, twice-daily
dosage of SPECTRACEF, for which Cornerstone received approval
from the FDA in July 2008;
|
|
|
SPECTRACEF Once Daily, a single tablet, once-daily dosage of
SPECTRACEF, for which Cornerstone expects to commence a clinical
trial in the fourth quarter of 2008 and additional clinical
trials in 2009, with an NDA submission targeted for
2010; and
|
|
|
SPECTRACEF Suspension, an oral, liquid suspension of SPECTRACEF,
for which Cornerstone expects to submit an NDA in 2009 for use
of this product candidate by children with pharyngitis or
tonsillitis and expects to conduct additional clinical trials in
2009 regarding acute otitis media and submit an sNDA for this
indication in 2010.
|
Cornerstone is developing the methscopolamine and antihistamine
combination product candidate for the treatment of symptoms of
allergic rhinitis. Cornerstone plans to file an IND for this
product candidate and to commence a clinical trial in the fourth
quarter of 2008, with an NDA submission targeted for 2010. The
hydrocodone cough suppressant product candidates are
extended-release antihistamine and antitussive, or cough
suppressant, combination products, for which Cornerstone plans
to submit applications for marketing approval in 2009 and, if
approved, to commercially launch these product candidates in
2010.
Collaboration
Agreement Revenues
In January 2005, Cornerstone entered into a co-promotion
agreement with Lupin Pharmaceuticals. Under this agreement,
Cornerstone agreed to co-promote Lupin Pharmaceuticals
Suprax, an oral suspension of cefixime, an anti-infective, in
exchange for the payment to Cornerstone of co-promotion fees
based on a percentage of specified levels of net sales.
Cornerstone earned approximately $1.1 million in
co-promotion revenue from
269
Lupin Pharmaceuticals for co-promoting Suprax in 2005. In May
2005, Cornerstone and Lupin Ltd. entered into a collaboration
and license agreement for the development and commercialization
of additional products. Under the terms of the agreement,
Cornerstone and Lupin Ltd. agreed to share development costs,
and Cornerstone agreed to make upfront and milestone payments to
Lupin Ltd. and issued a warrant to purchase
1,746,405 shares of its common stock to Lupin Ltd. In
February 2006, Lupin Pharmaceuticals notified Cornerstone that
it had terminated the co-promotion agreement due to
Cornerstones failure to meet certain requirements under
the agreement. In December 2006, Lupin Pharmaceuticals and Lupin
Ltd. entered into a settlement agreement providing, among other
things, for the cancellation of the warrant held by Lupin Ltd.
that was exercisable for shares of Cornerstones common
stock, for Cornerstone to release all of its interests in Suprax
and for Cornerstone to pay Lupin Ltd. $1.25 million. The
collaboration and license agreement was terminated in December
2006.
History
of Losses
From inception in 2004 through 2006, Cornerstone incurred
operating losses, including net losses of $305,000 in 2006 and
$11.4 million in 2005. Cornerstones net income was
$2.8 million in the six months ended June 30, 2008 and
$570,000 in the year ended December 31, 2007. As of
June 30, 2008, Cornerstones accumulated deficit was
$10.3 million. Cornerstone expects to continue to incur
significant development and commercialization expenses as it
seeks FDA approval for SPECTRACEF Once Daily and SPECTRACEF
Suspension; advances the development of its other product
candidates, including its methscopolamine and antihistamine
combination and hydrocodone cough suppressant product
candidates; seeks regulatory approvals for its product
candidates that successfully complete clinical testing; and
expands its sales team and marketing capabilities to prepare for
the commercial launch of future products, subject to FDA
approval. Cornerstone also expects to incur additional expenses
to add operational, financial and management information systems
and personnel, including personnel to support its product
development efforts. Accordingly, Cornerstone will need to
increase its revenues to be able to sustain and increase its
profitability. There is no assurance that Cornerstone will be
able to do so.
Financial
Operations Overview
Net
Revenues
Cornerstones net revenues are comprised of net product
sales, royalty agreement revenues and co-promotion fees.
Cornerstone recognizes product sales net of estimated allowances
for product returns; estimated rebates in connection with
contracts relating to managed care, Medicaid and Medicare;
estimated chargebacks; price adjustments; product vouchers;
co-pay vouchers; and prompt payment and other discounts. The
primary factors that determine Cornerstones net product
sales are the level of demand for Cornerstones products,
unit sales prices and the amount of sales adjustments that
Cornerstone recognizes. Royalty agreement revenues consist of
royalties Cornerstone receives under license agreements with
third parties that sell products to which Cornerstone has
rights. The primary factors that affect royalty agreement
revenues are the demand and sales prices for such products and
the royalty rates that Cornerstone receives on the sales of such
products by third parties. Co-promotion fees include royalties
Cornerstone earned in 2005 under its co-promotion agreement with
Lupin Pharmaceuticals.
Since Cornerstones inception in March 2004, approximately
94% of Cornerstones net revenues have been from product
sales, including sales of Cornerstones ALLERX Dose Pack
family of products, SPECTRACEF, BALACET 325 and its DECONSAL
products.
270
The following table sets forth a summary of Cornerstones
net revenues for the years ended December 31, 2007, 2006
and 2005 and for the six months ended June 30, 2008 and
2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Year Ended December 31,
|
|
|
Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2008
|
|
|
2007
|
|
|
|
(In thousands)
|
|
|
Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALLERX 10 Dose Pack/ALLERX 30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dose Pack(1)
|
|
$
|
11,103
|
|
|
$
|
11,349
|
|
|
$
|
10,141
|
|
|
$
|
6,015
|
|
|
$
|
7,483
|
|
ALLERX Dose Pack DF/ALLERX Dose
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pack DF 30
|
|
|
967
|
|
|
|
1,807
|
|
|
|
|
|
|
|
2,554
|
|
|
|
188
|
|
ALLERX Dose Pack PE/ALLERX Dose
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pack PE 30
|
|
|
1,439
|
|
|
|
1,342
|
|
|
|
|
|
|
|
3,935
|
|
|
|
232
|
|
SPECTRACEF
|
|
|
6,886
|
|
|
|
271
|
|
|
|
|
|
|
|
1,795
|
|
|
|
3,012
|
|
BALACET 325
|
|
|
4,403
|
|
|
|
2,943
|
|
|
|
1,667
|
|
|
|
3,103
|
|
|
|
1,470
|
|
DECONSAL CT and DECONSAL DM
|
|
|
99
|
|
|
|
1,146
|
|
|
|
|
|
|
|
457
|
|
|
|
62
|
|
Other currently marketed products
|
|
|
671
|
|
|
|
474
|
|
|
|
897
|
|
|
|
4,866
|
|
|
|
343
|
|
Discontinued products
|
|
|
679
|
|
|
|
1,107
|
|
|
|
2,913
|
|
|
|
|
|
|
|
690
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Net Product Sales
|
|
|
26,247
|
|
|
|
20,439
|
|
|
|
15,618
|
|
|
|
22,725
|
|
|
|
13,480
|
|
Royalty Agreement Revenues
|
|
|
1,824
|
|
|
|
1,678
|
|
|
|
753
|
|
|
|
787
|
|
|
|
723
|
|
Collaboration Agreement Revenues
|
|
|
|
|
|
|
|
|
|
|
1,099
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Revenues
|
|
$
|
28,071
|
|
|
$
|
22,117
|
|
|
$
|
17,470
|
|
|
$
|
23,512
|
|
|
$
|
14,203
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Net product sales amounts for ALLERX 10 Dose Pack/ALLERX 30 Dose
Pack include net product sales of the ALLERX Dose Pack product
prior to its reformulation as ALLERX 10 Dose Pack/ALLERX 30 Dose
Pack in February 2008. |
From time to time and, typically, at least once per year,
Cornerstone implements price increases on its branded products.
Cornerstones branded and generic products are subject to
rebates, chargebacks and other sales allowances that have the
effect of decreasing the net revenues that Cornerstone
ultimately realizes from product sales. Cornerstones
generic products may also be subject to substantial price
competition from equivalent generic products introduced by other
pharmaceutical companies. Such competition may also decrease
Cornerstones net revenues from the sale of its generic
products.
Cost
of Product Sales
Cornerstones cost of product sales is primarily comprised
of the costs of manufacturing and distributing
Cornerstones pharmaceutical products. In particular, cost
of product sales includes third-party manufacturing and
distribution costs, the cost of API, freight and shipping,
reserves for excess or obsolete inventory and labor, benefits
and related employee expenses for personnel involved with
overseeing the activities of Cornerstones third-party
manufacturers. Cost of product sales excludes amortization of
product rights.
Cornerstone contracts with third parties to manufacture all of
its products and product candidates. Changes in the price of raw
materials and manufacturing costs could adversely affect
Cornerstones gross margins on the sale of its products.
Changes in Cornerstones mix of products sold also affect
its cost of product sales. Accordingly, Cornerstones
management expects gross margins will change as its product mix
is altered by the launch of new products.
Sales
and Marketing Expenses
Cornerstones sales and marketing expenses consist of
labor, benefits and related employee expenses for personnel in
its sales, marketing and sales operations functions; advertising
and promotion costs, including the
271
costs of samples; and the fees it pays under its co-promotion
agreements to third parties to promote its products, which are
based on a percentage of net profits from product sales,
determined in accordance with the particular agreement. The most
significant component of Cornerstones sales and marketing
expenses is labor, benefits and related employee expenses for
its sales personnel.
In August 2004, shortly after its inception, Cornerstone hired
its first national sales director and its first four sales
managers, followed by its first class of 25 sales
representatives in January 2005. By December 31, 2005,
Cornerstone had grown its sales team to 74 sales professionals.
In January 2006, however, Cornerstone reduced the size of its
sales team to 30 sales professionals as part of a reduction in
force. Cornerstone implemented its January 2006 reduction in
force in connection with ceasing development of a product
candidate with the API cephalexin.
On July 10, 2007, Cornerstone and Meiji entered into a
letter agreement, which supplemented the SPECTRACEF license and
supply agreement. Under this letter agreement, Meiji agreed to
partially fund sales representative hiring expenses related to
the expansion of Cornerstones sales force that was
promoting SPECTRACEF from 35 sales representatives to 100 sales
representatives by the end of March 2008, with the amount of
Meiji funding dependent on Cornerstones aggregate gross
sales of SPECTRACEF during 2007. In September 2007, Cornerstone
added a commission-based sales force to complement its
pre-existing sales force, which continued to be compensated with
salaries, bonuses and related benefits. The addition of the
commission-based sales force included the hiring of 66 sales
representatives, as well as 5 sales managers and a second
national sales director, who was hired as a consultant. By
December 2007, Cornerstone had increased the size of its sales
force to 100 sales representatives. Pursuant to this letter
agreement, Meiji paid Cornerstone $1.5 million based on its
achievement of gross sales of SPECTRACEF in excess of
$8.0 million during 2007.
During the first part of 2008, through attrition and otherwise,
the number of Cornerstones sales professionals declined to
93 as of April 30, 2008. On May 1, 2008, Cornerstone
consolidated all of its sales functions under one national sales
director, reduced the size of its sales team to 59 sales
professionals and eliminated commission-based compensation for
the previous members of its commission-based sales team.
Following the reduction in force, Cornerstone began compensating
all of its sales professionals with salaries, bonuses and
related benefits.
Cornerstone expects that its sales and marketing expenses will
increase as it expands its sales and marketing infrastructure to
support additional products and product lines and as a result of
increased co-promotion fees due to greater product sales.
Royalty
Expenses
Royalty expenses include the contractual amounts Cornerstone is
required to pay the licensors from which it has acquired the
rights to its marketed products. Royalties are generally based
on a percentage of the products net sales. With respect to
the HYOMAX line of products, royalties are based on a percentage
of the net profits earned by Cornerstone on the sale of the
products. Additionally, as described in the section entitled
Cornerstones Business Legal
Proceedings of this proxy statement/prospectus,
Cornerstone has been engaged in litigation with several
companies that Cornerstone believes have infringed the 796
Patent by marketing pharmaceutical products intended as generic
equivalents of the former formulation of ALLERX 10 Dose
Pack and ALLERX 30 Dose Pack. In connection with the settlement
of such litigation, Cornerstone sometimes has agreed to pay
royalties with respect to future sales of ALLERX 10 Dose Pack
and ALLERX 30 Dose Pack, including their former formulation and
any new formulations. Cornerstone has agreed to pay these
royalties in exchange for the other party agreeing to withdraw
its challenges to the validity of the 796 Patent and to
cease marketing products that compete with the ALLERX Dose Pack
family of products. Any such payments pursuant to a settlement
agreement are also included in royalty expenses. Although
product mix affects Cornerstones royalties, Cornerstone
generally expects that its royalty expenses will increase as
total net product sales increase.
272
General
and Administrative Expenses
General and administrative expenses primarily include labor,
benefits and related employee expenses for personnel in
executive, finance, accounting, business development,
information technology, regulatory/medical affairs and human
resource functions. Other costs include facility costs not
otherwise included in sales and marketing or research and
development expenses and professional fees for legal and
accounting services. General and administrative expenses also
consist of the costs of maintaining and overseeing
Cornerstones intellectual property portfolio, which
include the cost of external legal counsel and the mandatory
fees of the U.S. Patent and Trademark Office. Beginning in
December 2006, Cornerstone has recorded the expenses of its
Aristos subsidiary in general and administrative expenses.
Cornerstone expects that general and administrative expenses
will increase as it continues to build the infrastructure
necessary to support its commercialization and research and
development activities and meeting its compliance obligations as
a public company. In addition, Cornerstone has incurred, and
expects to continue to incur, additional legal, accounting and
related costs relating to its proposed merger with Critical
Therapeutics.
Research
and Development Expenses
Research and development expenses consist of costs incurred in
identifying, developing and testing product candidates. These
expenses consist primarily of labor, benefits and related
employee expenses for personnel, fees paid to professional
service providers for monitoring and analyzing clinical trials,
expenses incurred under joint development agreements, regulatory
costs, costs of contract research and manufacturing and the cost
of facilities used by Cornerstones research and
development personnel. Cornerstone expenses research and
development costs as incurred. Cornerstone believes that
significant investment in research and development is important
to its competitive position and plans to increase its
expenditures for research and development to realize the
potential of the product candidates that it is developing or may
develop.
The following table summarizes Cornerstones research and
development expenses for each of the years ended
December 31, 2007, 2006 and 2005 and the six months ended
June 30, 2008 and 2007. The expenses summarized in the
following table reflect costs directly attributable to product
candidates currently in development and to product candidates
for which Cornerstone has discontinued development.
Additionally, research and development expenses include
Cornerstones costs of qualifying new cGMP third-party
manufacturers for its products, including expenses associated
with any related technology transfer. Cornerstone does not
allocate salaries, benefits or other indirect costs to the
research and development expenses associated
273
with individual product candidates. Rather, Cornerstone includes
these costs in general and administrative expenses.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
|
|
|
Ended June 30,
|
|
|
Year Ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(In thousands)
|
|
|
(In thousands)
|
|
|
In development:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SPECTRACEF 400 mg(1)
|
|
$
|
30
|
|
|
|
15
|
|
|
$
|
383
|
|
|
|
|
|
|
|
|
|
SPECTRACEF Once Daily
|
|
|
111
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SPECTRACEF Qualification of Backup Manufacturer
|
|
|
|
|
|
|
6
|
|
|
|
90
|
|
|
|
|
|
|
|
|
|
SPECTRACEF Suspension
|
|
|
63
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALLERX
|
|
|
57
|
|
|
|
83
|
|
|
|
402
|
|
|
|
231
|
|
|
|
|
|
DECONSAL
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
Methscopolamine/Antihistamine Product Candidate (CBP 058)
|
|
|
256
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hydrocodone Cough Suppressant Product Candidates (CBP 067 and
CBP 069)
|
|
|
77
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generic Product Development
|
|
|
5
|
|
|
|
|
|
|
|
73
|
|
|
|
|
|
|
|
|
|
Discontinued development:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cephalexin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
|
|
|
|
266
|
|
Other
|
|
|
6
|
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
605
|
|
|
$
|
113
|
|
|
$
|
948
|
|
|
$
|
249
|
|
|
$
|
266
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) The FDA approved SPECTACEF 400 mg in July 2008.
Research and development expenses for SPECTRACEF 400 mg of
$30,000 in the six months ended June 30, 2008 and of
$383,000 in 2007 are related to formulation work, a
bioequivalence study, the sNDA submission for SPECTRACEF
400 mg and related consulting costs.
Research and development expenses for ALLERX of $57,000 in the
six months ended June 30, 2008 consist of costs incurred for
ALLERX NDA studies and validation studies for the qualification
of new facilities to manufacture bulk tablets for the ALLERX
product line. Research and development expenses for ALLERX were
$402,000 in 2007 and were incurred for validation studies and
manufacturing methodology and technology transfer in connection
with a change in Cornerstones third-party manufacturing
site used to produce bulk tablets for the ALLERX product line.
Research and development expenses for ALLERX were $231,000 in
2006 and were incurred for life cycle product development of the
ALLERX family of products.
Amortization
and Depreciation Expenses
Cornerstone capitalizes its costs to license product rights from
third parties as such costs are incurred and amortizes these
amounts on a straight-line basis over the estimated useful life
of the product or the remaining trademark or patent life,
whichever is shorter. Cornerstone re-evaluates the useful life
of its products on an annual basis to determine whether the
value of its product rights assets have been impaired and
appropriately adjusts amortization to account for such
impairment. Amortization and depreciation expense also includes
depreciation expense for Cornerstones property and
equipment, which it depreciates over the estimated useful lives
of the assets using the straight-line method. Amortization and
depreciation expenses are expected to increase in the future as
Cornerstone begins amortizing product rights related to new
products.
274
Other
Charges
Other charges include miscellaneous expenses related to
settlements of litigation, costs incurred in 2006 related to a
merger that was not consummated and Cornerstones
forfeiture of product rights to market Suprax in connection with
the termination in 2006 of its co-promotion agreement with Lupin
Pharmaceuticals.
Basis
of Presentation
Cornerstones consolidated financial statements include the
accounts of Cornerstone BioPharma Holdings, Inc. and its wholly
owned subsidiaries Cornerstone BioPharma, Inc., Cornerstone
Biopharma, Ltd. and Aristos.
Critical
Accounting Estimates
Managements discussion and analysis of Cornerstones
financial condition and results of operations are based on
Cornerstones consolidated financial statements, which have
been prepared in accordance with accounting principles generally
accepted in the United States. The preparation of its financial
statements requires Cornerstones management to make
estimates and assumptions that affect Cornerstones
reported assets and liabilities, revenues and expenses and other
financial information. Actual results may differ significantly
from these estimates under different assumptions and conditions.
In addition, Cornerstones reported financial condition and
results of operations could vary due to a change in the
application of a particular accounting standard.
Cornerstone regards an accounting estimate or assumption
underlying its financial statements as a critical
accounting estimate where:
|
|
|
the nature of the estimate or assumption is material due to the
level of subjectivity and judgment necessary to account for
highly uncertain matters or the susceptibility of such matters
to change; and
|
|
|
the impact of the estimates and assumptions on its financial
condition or operating performance is material.
|
Cornerstones significant accounting policies are described
in the notes to Cornerstones consolidated financial
statements appearing elsewhere in this proxy
statement/prospectus. Not all of these significant accounting
policies, however, fit the definition of critical
accounting estimates. Cornerstone believes that its
estimates relating to revenue recognition, product rights,
inventory, accrued expenses and stock-based compensation
described below fit the definition of critical accounting
estimates.
Revenue
Recognition
Product Sales. Cornerstone recognizes revenue
from its product sales in accordance with SEC Staff Accounting
Bulletin No. 104, Revenue Recognition, and
SFAS 48, upon transfer of title, which occurs when product
is received by its customers. Cornerstone sells its products
primarily to pharmaceutical wholesalers, distributors and
pharmacies, which have the right to return the products they
purchase. Under SFAS 48, Cornerstone is required to
reasonably estimate the amount of future returns at the time of
revenue recognition. Cornerstone recognizes product sales net of
estimated allowances for product returns; estimated rebates in
connection with contracts relating to managed care, Medicaid and
Medicare; estimated chargebacks; price adjustments; product
vouchers; co-pay vouchers; and prompt payment and other
discounts.
Cornerstone establishes revenue reserves on a
product-by-product
basis as its best estimate at the time of sale based on
historical experience for each product adjusted to reflect known
changes in the factors that impact such reserves. Reserves for
chargebacks, rebates, vouchers and related allowances are
established based upon contractual terms with customers;
analysis of historical levels of discounts, chargebacks, rebates
and voucher redemptions; communications with customers;
purchased information about the rate of prescriptions being
written and the levels of inventory remaining in the
distribution channel; expectations about the market for each
product; and anticipated introduction of competitive products.
Cornerstones revenue reserves may prove insufficient for a
variety of reasons, including unanticipated competition,
regulatory actions or changes in one
275
or more of Cornerstones contractual relationships. The
reserves for returns, rebates and price adjustments are the most
significant estimates used in the recognition of revenue from
product sales.
Consistent with industry practice, Cornerstone offers customers
the ability to return products in the six months prior to, and
the 12 months after, the products expire. Cornerstone
adjusts its estimate of product returns if it becomes aware of
other factors that it believes could significantly impact its
expected returns. These factors include its estimate of
inventory levels of its products in the distribution channel,
the shelf life of the product shipped, competitive issues such
as new product entrants and other known changes in sales trends.
Cornerstone evaluates this reserve on a quarterly basis,
assessing each of the factors described above, and adjusts the
reserve accordingly.
Cornerstone typically requires customers of branded and generic
products to remit payments within 31 days and 61 days,
respectively. In addition, Cornerstone offers wholesale
distributors a prompt payment discount as an incentive to remit
payment within the first 30 days after the date of its
invoice for branded products and 60 days after the date of
its invoice for generic products. This discount is generally 2%,
but may be higher in some instances due to product launches or
customer and/or generic industry expectations. Because its
wholesale distributors typically take the prompt payment
discount, Cornerstone accrues 100% of the prompt payment
discounts, based on the gross amount of each invoice, at the
time of its original sale to them, and Cornerstone applies
earned discounts at the time of payment. Cornerstone adjusts the
accrual periodically to reflect actual experience. Historically,
these adjustments have not been material. Cornerstone does not
anticipate that future changes to its estimates will have a
material impact on its net revenue.
Cornerstones estimates of rebates, price adjustments and
chargebacks are based on its estimated mix of sales to various
third-party payors, which are entitled either contractually or
statutorily to discounts from Cornerstones listed prices
of its products. Cornerstone makes these judgments based upon
the facts and circumstances known to it in accordance with GAAP.
In the event that the sales mix to third-party payors is
different from its estimates, Cornerstone may be required to pay
higher or lower total rebates, price adjustments and/or
chargebacks than it has estimated.
The following table provides a summary of activity with respect
to Cornerstones sales allowances:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prompt
|
|
|
Rebates
|
|
|
|
|
|
|
|
|
|
Payment
|
|
|
and Price
|
|
|
|
|
|
Sales
|
|
|
|
Discounts
|
|
|
Adjustments
|
|
|
Chargebacks
|
|
|
Returns
|
|
|
Balance at January 1, 2005
|
|
$
|
75
|
|
|
$
|
120
|
|
|
|
|
|
|
$
|
282
|
|
Current provision
|
|
|
472
|
|
|
|
1,186
|
|
|
|
1,194
|
|
|
|
5,792
|
|
Payments and credits
|
|
|
(526
|
)
|
|
|
(814
|
)
|
|
|
(381
|
)
|
|
|
(156
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
21
|
|
|
|
492
|
|
|
|
813
|
|
|
|
5,918
|
|
Current provision
|
|
|
470
|
|
|
|
100
|
|
|
|
600
|
|
|
|
2,987
|
|
Payments and credits
|
|
|
(447
|
)
|
|
|
(155
|
)
|
|
|
(1,023
|
)
|
|
|
(3,124
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
44
|
|
|
|
437
|
|
|
|
390
|
|
|
|
5,781
|
|
Current provision
|
|
|
645
|
|
|
|
1,302
|
|
|
|
185
|
|
|
|
2,879
|
|
Payments and credits
|
|
|
(608
|
)
|
|
|
(795
|
)
|
|
|
(388
|
)
|
|
|
(3,747
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
81
|
|
|
|
944
|
|
|
|
187
|
|
|
|
4,913
|
|
Current provision
|
|
|
788
|
|
|
|
984
|
|
|
|
438
|
|
|
|
2,656
|
|
Changes in prior year estimate
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500
|
|
Payments and credits
|
|
|
(630
|
)
|
|
|
(739
|
)
|
|
|
(55
|
)
|
|
|
(3,916
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2008
|
|
$
|
239
|
|
|
$
|
1,189
|
|
|
$
|
570
|
|
|
$
|
4,153
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales returns are Cornerstones most significant category
of sales allowances. Sales returns related to current year
provisions were $2.7 million in the six months ended
June 30, 2008, or 9% of gross product sales. Sales returns
related to changes in prior year estimates in the six months
ended June 30, 2008 were $500,000 and related to product
returns of SPECTRACEF and DECONSAL. Sales returns were
$2.9 million, $3.0 million
276
and $5.8 million in 2007, 2006 and 2005, respectively,
representing 9%, 12% and 25% of gross product sales in 2007,
2006 and 2005, respectively. The higher rate of sales returns in
2005 is primarily due to the January 2006 reduction in force,
which resulted in Cornerstone having excess BALACET 325
inventory in the distribution channel as of December 31,
2005.
Rebates and price adjustments were $984,000 in the six months
ended June 30, 2008, or 4% of gross product sales. Rebates
and price adjustments were $1.3 million, $100,000 and
$1.2 million in 2007, 2006 and 2005, representing
approximately 4%, 1% and 5% of gross product sales in 2007, 2006
and 2005, respectively.
Chargebacks were $438,000 in the six months ended June 30, 2008,
or 2% of gross product sales. Chargebacks were $185,000,
$600,000 and $1.2 million in 2007, 2006 and 2005,
respectively, representing approximately 1%, 2% and 5% of gross
product sales in 2007, 2006 and 2005, respectively.
Prompt payment discounts were $788,000 in the six months ended
June 30, 2008, or approximately 3% of gross product sales.
Prompt payment discounts were $645,000, $470,000 and $472,000 in
2007, 2006 and 2005, respectively, representing approximately 2%
of gross product sales in each year.
Royalty Agreement Revenues. Cornerstone also
receives royalties under license agreements with a number of
third parties that sell products to which Cornerstone has
rights. The license agreements provide for the payment of
royalties based on sales of the licensed product. These revenues
are recorded based on estimates of the sales that occurred in
the relevant period. The relevant period estimates of sales are
based on interim data provided by the licensees and analysis of
historical royalties paid, adjusted for any changes in facts and
circumstances, as appropriate. Cornerstone maintains regular
communication with its licensees to gauge the reasonableness of
its estimates. Differences between actual royalty agreement
revenues and estimated royalty agreement revenues are
reconciled and adjusted for in the period in which they become
known, typically the following quarter.
Collaboration Agreement Revenues. Cornerstone
recognized collaboration agreement revenues as a result of a
co-promotion agreement with Lupin Pharmaceuticals. Revenues
associated with this agreement was recognized based on the
calculation of shared revenues using an
agreed-upon
average sales price that was applied to the sales volume
generated by Cornerstone. The sales volume was based on an
analysis of prescription-level data by assigned, targeted
prescribers within the United States.
Product
Rights
Product rights are capitalized as incurred and are amortized
over the estimated useful life of the product or the remaining
trademark or patent life, whichever is shorter, on a
straight-line or other basis to match the economic benefit
received. Amortization begins once FDA approval has been
obtained and commercialization of the product begins.
Cornerstone evaluates its product rights annually to determine
whether a revision to their useful lives should be made. This
evaluation is based on Cornerstones managements
projection of the future cash flows associated with the
products. At June 30, 2008, Cornerstone had an aggregate of
$14.4 million in capitalized products rights, which it
expects to amortize over a period of one to 15 years.
Inventory
Inventory consists of raw materials, work in process and
finished goods. Raw materials include the API for a product to
be manufactured, work in process includes the bulk inventory of
tablets that are in the process of being packaged for sale, and
finished goods include pharmaceutical products ready for
commercial sale or distribution as samples. Inventory is stated
at the lower of cost or market value with cost determined under
the
first-in,
first-out, or FIFO, method. Cornerstones estimate of the
net realizable value of its inventories is subject to judgment
and estimation. The actual net realizable value of its
inventories could vary significantly from its estimates and
could have a material effect on its financial condition and
results of operations in any reporting period. In evaluating
whether inventory is stated at the lower of cost or market,
Cornerstone considers such factors as the amount of inventory on
hand and in the distribution channel, estimated time required to
sell such inventory, remaining shelf life and current and
expected market conditions, including levels of competition. On
a quarterly basis, Cornerstone analyzes its inventory levels and
writes down
277
inventory that has become obsolete, inventory that has a cost
basis in excess of the expected net realizable value and
inventory that is in excess of expected requirements based upon
anticipated product revenues. At June 30, 2008, Cornerstone
had an inventory reserve of $97,000. The inventory reserve
includes provisions for inventory that management believes will
become short-dated before being sold. Short-dated inventory is
inventory that has not expired yet, but which wholesalers or
pharmacies refuse to purchase because of its near-term
expiration date. As of June 30, 2008, Cornerstone had
$3.7 million in inventory.
Accrued
Expenses
As part of the process of preparing its consolidated financial
statements, Cornerstone is required to estimate certain
expenses. This process involves identifying services that have
been performed on its behalf and estimating the level of service
performed and the associated cost incurred for such service as
of each balance sheet date in its consolidated financial
statements. Examples of estimated expenses for which Cornerstone
accrues include research and development expenses, reserves for
product returns, rebates to third parties, including government
programs such as Medicaid or private insurers, royalties owed to
third-parties on sales of products, interest owed on debt
instruments, and compensation and benefits for employees.
Stock-Based
Compensation
Effective January 1, 2006, Cornerstone adopted the fair
value recognition provisions of SFAS 123(R), using the
prospective application method, which requires Cornerstone to
recognize compensation cost for all awards and awards granted or
modified after January 1, 2006. Awards outstanding at
January 1, 2006 continue to be accounted for using the
accounting principles originally applied to the award. The
expense associated with stock-based compensation is recognized
on a straight-line basis over the service period of each award.
Prior to the adoption of SFAS 123(R), Cornerstone
recognized employee stock-based compensation expense using the
intrinsic value method, which measures stock-based compensation
expense as the amount at which the market price of the stock at
the date of grant exceeds the exercise price. Because the
exercise price for options awarded to employees is equal to the
fair value at the grant date, Cornerstone did not recognize
compensation expense for stock options granted to employees
prior to 2006.
Cornerstone accounts for transactions in which services are
received in exchange for equity instruments based on the fair
value of such services received from non-employees or of the
equity instruments issued, whichever is more reliably measured,
in accordance with SFAS 123(R). Cornerstone uses the
Black-Scholes-Merton option-pricing model to calculate the fair
value of stock-based compensation under SFAS 123(R). There
are a number of assumptions used to calculate the fair value of
stock options or restricted stock issued to employees under this
pricing model.
The two factors that most affect stock-based compensation are
the estimate of the underlying fair value of the Companys
common stock and the estimate of the stock price volatility.
Accounting for equity instruments granted by Cornerstone under
SFAS 123(R) and EITF Issue
No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services, requires Cornerstone to estimate the fair
value of the equity instruments granted. If Cornerstones
estimates of the fair value of these equity instruments are too
high or too low, stock-based compensation expense will be
overstated or understated, respectively. When equity instruments
are granted or sold in exchange for the receipt of goods or
services and the value of those goods or services can be readily
estimated, Cornerstone uses the value of such goods or services
to determine the fair value of the equity instruments. When
equity instruments are granted or sold in exchange for the
receipt of goods or services and the value of those goods or
services cannot be readily estimated, as is true in connection
with most compensatory stock options and warrants granted to
employees and non-employees, Cornerstones board of
directors determines fair value contemporaneously with the
issuance or grant. In determining fair value for each issuance
or grant, the board considered Cornerstones results of
operations; the book value of its stock; its available cash,
assets and financial condition; its prospects for growth; the
economic outlook in general and the condition and outlook of the
pharmaceutical industry in particular; its competitive position
in the market; the market price of stocks of corporations
engaged in the same or similar line of business that are
actively traded in a free and open market,
278
either on an exchange or over-the-counter; positive or negative
business developments since the boards last determination
of fair value; and such additional factors that it deemed
relevant at the time of the grant or issuance.
For example, in addition to the factors enumerated above,
Cornerstones board of directors specifically considered
the following in making its determination of fair value. With
respect to the grants on May 15, 2005, June 15, 2005
and July 1, 2005, given Cornerstones portfolio of
product rights on such grant dates, Cornerstone was unable to
effectively leverage its existing sales force and its fixed
operating costs. With respect to the grants on January 17,
2006, February 1, 2006, February 8, 2006,
February 23, 2006 and April 25, 2006, although
Cornerstone had experienced significant erosion during fiscal
year 2005 in its financial condition, a restructuring plan was
in place and net income was expected to be positive in 2006.
With respect to the grants on March 16, 2007, May 24,
2007, September 14, 2007 and December 5, 2007,
Cornerstones financial performance was improving due to
growing product sales, relatively strong gross margins, and
leveraging of its sales force and fixed overhead.
Results
of Operations
Comparison
of the Six Months Ended June 30, 2008 and
2007
Net
Revenues
Net Product Sales. Net product sales were
$23.5 million in the six months ended June 30, 2008,
compared to $14.2 million in the six months ended
June 30, 2007, an increase of approximately
$9.3 million, or 65%.
Net product sales in the six months ended June 30, 2008 and June
30, 2007 consisted of revenues from sales of Cornerstones
ALLERX family of products and its SPECTRACEF, BALACET 325 and
DECONSAL products. Net product sales in the six months ended
June 30, 2008 also included the HYOMAX products Cornerstone
launched in May and June 2008. The increase in net revenues is
primarily due to the following:
|
|
|
$4.5 million of net revenues from Cornerstones HYOMAX line
of products;
|
|
|
a $1.6 million increase in net product sales of BALACET 325.
This increase is primarily due to wholesaler purchases that
occurred in January 2008 following a price increase. Cornerstone
gave wholesalers the opportunity to purchase product at a
discount off the new price; and
|
|
|
a $4.6 million increase in net product sales of the ALLERX Dose
Pack family of products. This increase is primarily due to a
combination of price and volume increases. Volume increases were
primarily due to the launch of ALLERX Dose Pack DF 30 and ALLERX
Dose Pack PE 30 in July 2007 and October 2007,
respectively, offset, in part, by a $1.5 million decrease in net
product sales of ALLERX 10 Dose Pack and ALLERX 30 Dose Pack as
a result of generic competition, which was mitigated, in part,
by price increases.
|
These increases were offset, in part, by a $1.2 million decrease
in net product sales of SPECTRACEF due to decreased wholesaler
purchasing activity in the first six months of 2008 as there was
sufficient supply of product in the distribution channel.
Royalty Agreement Revenues. Royalty agreement
revenues were $787,000 in the six months ended June 30,
2008, compared to $723,000 in the six months ended June 30,
2007, an increase of approximately $64,000, or 9%. This increase
was primarily due to a $92,000 increase in royalty
agreement revenues from APAP 500, offset, in part, by a
$25,000 decrease in Humibid royalty agreement revenues, as
royalties on this product ended in January 2008 in accordance
with the January 14, 2005 settlement agreement between Adams and
Cornerstone.
Costs and
Expenses
Cost of Product Sales. Cost of product sales
(exclusive of amortization of product rights of $848,000 and
$1.7 million in the six months ended June 30, 2008 and
2007, respectively) was $1.5 million in both the six months
ended June 30, 2008 and June 30, 2007. Gross margin (exclusive
of amortization of product rights of $848,000 and
$1.7 million in the six months ended June 30, 2008 and
2007, respectively) was approximately 93% in the six months
ended June 30, 2008 and 89% in the six months ended June 30,
2007. Cost of product
279
sales in the six months ended June 30, 2008 and June 30, 2007
consisted primarily of the expenses associated with
manufacturing and distributing the ALLERX family of products,
BALACET 325 and SPECTRACEF, reserves established for excess or
obsolete inventory and other direct costs of product sales, such
as package inserts and artwork. Cost of product sales in the six
months ended June 30, 2008 also included the expenses associated
with manufacturing and distributing the HYOMAX line of products.
Cornerstone reduced obsolescence reserves by $3,000 in the six
months ended June 30, 2008 and established additional inventory
obsolescence reserves of $93,000 in the six months ended June
30, 2007. These adjustments in the obsolescence reserves
resulted from changes in Cornerstones estimates related to
excess or obsolete inventory that could become short-dated prior
to being sold.
Sales and Marketing Expenses. Sales and
marketing expenses were $7.5 million in the six months
ended June 30, 2008, compared to $4.9 million in the
six months ended June 30, 2007, an increase of
approximately $2.6 million, or 55%. This increase was
primarily due to the following:
|
|
|
an $884,000 increase in co-promotion expenses related to
Cornerstones BALACET 325, SPECTRACEF and ALLERX Dose Pack
products;
|
|
|
an $827,000 increase in labor, benefits and related employee
expenses as a result of the expansion of Cornerstones
sales team in September 2007;
|
|
|
a $658,000 increase in advertising and promotion expenses,
primarily attributable to $624,000 increase in advertising and
promotion expenses for SPECTRACEF;
|
|
|
a $183,000 increase in consulting expenses primarily related to
market research and consulting fees; and
|
|
|
a $178,000 increase in travel-related expenses that was due to
the sales team expansion.
|
Royalty Expenses. Royalty expenses were $4.8
million in the six months ended June 30, 2008, compared to $1.6
million in the six months ended June 30, 2007, an increase of
approximately $3.2 million, or 195%. This increase was primarily
due to $2.4 million of royalty expenses related to sales of the
HYOMAX line of products in the six months ended June 30, 2008.
Cornerstone launched one HYOMAX product in May 2008 and two
HYOMAX products in June 2008. The remainder of this increase was
primarily due to increased sales of BALACET 325 and of the
ALLERX Dose Pack family of products, offset, in part, by
decreased sales of APAP 500.
General and Administrative Expenses. General
and administrative expenses were $3.8 million in the six
months ended June 30, 2008, compared to $2.1 million
in the six months ended June 30, 2007, an increase of
approximately $1.7 million, or 82%. This increase was
primarily due to a $138,000 increase in labor, benefits and
related employee expenses as a result of additional headcount;
$488,000 in expenses related to Aristos, which began operations
in November 2007; and $958,000 increase in legal and consulting
fees related to the proposed merger with Critical Therapeutics.
Research and Development Expenses. Research
and development expenses were $605,000 in the six months ended
June 30, 2008, compared to $113,000 in the six months ended
June 30, 2007. This increase was primarily due to the
following:
|
|
|
a $256,000 increase in the expenses relating to the development
of the methscopolamine/antihistamine product candidate, CBP 058;
|
|
|
a $77,000 increase in the research and development expenses
related to the hydrocodone cough suppressant product candidates,
CBP 067 and CBP 069; and
|
|
|
a $183,000 increase in expenses in connection with
Cornerstones SPECTRACEF life cycle extension programs,
including expenses incurred for development work related to the
approval of SPECTRACEF 400 mg and the formulation of
SPECTRACEF Once Daily.
|
Amortization and Depreciation
Expenses. Amortization and depreciation expenses
were $886,000 in the six months ended June 30, 2008, compared to
$1.7 million in the six months ended June 30, 2007, a decrease
of approximately $800,000, or 47%. This decrease was primarily
due to the following:
280
|
|
|
a $629,000 decrease in amortization expense associated with the
BALACET product rights due to these product rights being fully
amortized as of March 31, 2008; and
|
|
|
a $177,000 decrease in amortization expense associated with the
SPECTRACEF product rights due to the extension of the estimated
useful life of these rights as a result of the July 27, 2007
letter agreement with Meiji, offset, in part, by the
capitalization of additional SPECTRACEF product rights.
|
Other Charges. In the six months ended June
30, 2008, Cornerstone incurred other charges in the amount of
$27,000, a decrease of $104,000 compared to the six months ended
June 30, 2007. This decrease was primarily due to lower
litigation expenses during the six months ended June 30, 2008.
Other
Expenses
Interest expense, net, was $722,000 in the six months ended
June 30, 2008, compared to $657,000 in the six months ended
June 30, 2007, an increase of approximately $65,000, or
10%. This increase was primarily due to the increase in the
license agreement liability related to SPECTRACEF product
rights, offset, in part, by a $33,000 decrease in the interest
expense related to the Paragon line of credit.
Provision
for Income Taxes
The provision for income taxes from continuing operations was
$839,000 in the six months ended June 30, 2008, compared to
$534,000 in the six months ended June 30, 2007. This increase in
the provision for income taxes was due to the increase in income
before income taxes from $1.5 million in the six months ended
June 30, 2007 to $3.7 million in the six months ended June
30, 2008. The effective tax rate was 23.9% in the six months
ended June 30, 2008 and 34.7% in the six months ended June 30,
2007.
Comparison
of the Year Ended December 31, 2007 and 2006
Net
Revenues
Net Product Sales. Net product sales were
$26.2 million in 2007, compared to $20.4 million in
2006, an increase of approximately $5.8 million, or 28%.
Net product sales in 2007 and 2006 consisted of revenues from
sales of Cornerstones ALLERX family of products and its
SPECTRACEF, DECONSAL and BALACET 325 products. The increase
in 2007 is primarily due to:
|
|
|
a $6.6 million increase in net product sales of SPECTRACEF,
which was launched in November 2006; and
|
|
|
a $1.5 million increase in net product sales of
BALACET 325 that was primarily due to a 63% increase in the
products wholesale acquisition price.
|
These increases in net product sales were offset, in part, by:
|
|
|
a $1.3 million decrease in net product sales of DECONSAL
products as a result of the FDAs requirement that
DECONSAL II be removed from the market and the decline in
sales of the DECONSAL CT Tannate Chewable Tablets and DECONSAL
DM Tannate Chewable Tablets because initial sales in 2006 of the
chewable tablets to wholesalers for inventory in the
distribution channel were not repeated in 2007; and
|
|
|
a $791,000 decrease in net product sales of the ALLERX Dose Pack
family of products as a result of increased generic competition.
|
Royalty Agreement Revenues. Royalty agreement
revenues were $1.8 million in 2007, compared to
$1.7 million in 2006, an increase of approximately
$146,000, or 9%. This increase was primarily due to a $640,000
increase in royalty agreement revenues from APAP 500 and a
$332,000 increase in royalty agreement revenues received
pursuant to a settlement agreement with a competitor that had
infringed the 796 Patent by selling generic
equivalents of the former formulation of ALLERX 10 Dose
Pack and ALLERX 30 Dose Pack. These increases were offset,
in part, by a $826,000 decrease in royalty agreement
281
revenues relating to Extendryl as a result of an increase in
product returns experienced by the licensee, Auriga, in 2007.
Costs and
Expenses
Cost of Product Sales. Cost of product sales
(exclusive of amortization of product rights of
$3.2 million and $2.6 million in 2007 and 2006,
respectively) was $3.3 million in 2007, compared to
$2.2 million in 2006, an increase of approximately
$1.1 million, or 53%. Gross margin (exclusive of
amortization of product rights of $3.2 million and
$2.6 million in 2007 and 2006, respectively) was 87% in
2007 and 89% in 2006. Cost of product sales in 2007 and 2006
consisted primarily of the expenses associated with
manufacturing and distributing products, including the ALLERX
Dose Pack family of products and the SPECTRACEF, BALACET 325 and
DECONSAL products, and reserves established for excess or
obsolete inventory. Cornerstone recorded inventory write-offs of
$169,000 in 2007. The write-offs in 2007 resulted from excess or
obsolete inventory that, due to its expiration dating, would not
be sold. In 2006, Cornerstone reduced its inventory reserve by
$101,000 as a result of repackaging as samples commercial
product that had been reserved for in 2005 because management
believed that it had become unsalable because it was short-dated.
Sales and Marketing Expenses. Sales and
marketing expenses were $10.4 million in 2007, compared to
$7.1 million in 2006, an increase of approximately
$3.3 million, or 46%. This increase was primarily due to
the following:
|
|
|
a $1.3 million increase in advertising and promotional
expenses primarily due to samples and sample distribution;
|
|
|
a $1.8 million increase in labor, benefits and related
employee expenses as a result of the expansion of
Cornerstones sales team in 2007;
|
|
|
a $670,000 increase in the co-promotion fee paid for the
promotion of the ALLERX Dose Pack family of products, BALACET
325 and SPECTRACEF;
|
|
|
a $576,000 increase in stock-based compensation expense; and
|
|
|
a $618,000 increase in travel and other employee related
expenses due to the hiring of 78 additional sales
representatives in 2007.
|
These increases were offset, in part, by a $1.5 million
reimbursement of sales and marketing expenses by Meiji to
support Cornerstones sales force expansion in the third
quarter of 2007.
Royalty Expenses. Royalty expenses were
$3.4 million in 2007, compared to $1.7 million in
2006, an increase of approximately $1.7 million, or 105%.
This increase was primarily due to higher sales of BALACET 325
and SPECTRACEF, offset, in part, by lower sales of DECONSAL
products. In addition, royalty expenses related to the ALLERX
Dose Pack family of products increased in 2007 due to new
royalty obligations under settlement agreements entered into by
Cornerstone in 2007 with generic competitors in exchange for
such competitors agreement to withdraw their challenges to the
validity of the 796 Patent and to cease marketing products
that compete with the ALLERX Dose Pack family of products. These
additional royalty agreements increased royalty expenses
$475,000 as compared to 2006.
General and Administrative Expenses. General
and administrative expenses were $4.1 million in 2007,
compared to $3.7 million in 2006, an increase of
approximately $428,000, or 12%. This increase was primarily due
to a $519,000 increase in labor, benefits, related employee
expenses and stock-based compensation expense principally
related to Cornerstones executive, finance and regulatory
functions. This increase was offset, in part, by an $83,000
decrease in audit, legal and consulting expenses.
Research and Development Expenses. Research
and development expenses were $948,000 in 2007, compared to
$249,000 in 2006, an increase of approximately $699,000, or
280%. This increase was primarily due to:
|
|
|
a $474,000 increase in expenses in connection with
Cornerstones SPECTRACEF life cycle extension programs,
including expenses incurred for a bioequivalence study, the sNDA
submission for SPECTRACEF 400 mg and related consulting
costs; and
|
282
|
|
|
a $171,000 increase in expenses primarily related to validation
studies and manufacturing methodology and technology transfer in
connection with a change in Cornerstones third-party
manufacturing site used to produce bulk tablets for the ALLERX
product line.
|
Amortization and Depreciation
Expenses. Amortization and depreciation expenses
were $3.2 million in 2007, compared to $2.7 million in
2006, an increase of approximately $527,000, or 19%. This
increase was primarily due to Cornerstones acquisition of
the SPECTRACEF product rights in October 2006, which Cornerstone
began amortizing in November 2006.
Other Charges. Other charges were $245,000 in
2007, compared to $3.6 million in 2006, a decrease of
approximately $3.3 million, or 93%. In 2007, other charges
consisted of expenses related to the settlement of litigation.
In 2006, other charges consisted of $1.2 million of
expenses related to litigation with Lupin Pharmaceuticals and
Lupin Ltd., $1.7 million of expenses related to the
forfeiture of the Lupin Ltd. product rights, $472,000 of
expenses related to litigation with generic competitors and
$240,000 of foregone merger costs.
Other
Expenses
Interest Expense, net. Net interest expense
was $1.4 million in 2007, compared to $1.3 million in
2006, an increase of approximately $170,000, or 14%. This
increase was primarily due to a $283,000 increase in interest
expense related to the SPECTRACEF license agreement liability,
offset, in part, by a $135,000 decrease in interest expense
related to the Carolina Note and a $21,000 decrease in interest
expense related to the Paragon line of credit. In addition,
interest earned on related party notes decreased by $43,000.
Loss on Marketable Security. Also included in
other expense in 2007 was $324,000 related to losses on
marketable securities related to the Cornerstone investment in
Auriga. Cornerstone recorded this loss as the result of
managements determination that the decline in the value of
these securities was other than temporary. There were no losses
on marketable securities in 2006.
Provision
for Income Taxes
The provision for income taxes was $130,000 in 2007, compared to
$0 in 2006. This increase is due to income before income taxes
of $701,000 in 2007, compared to a loss before income taxes of
$305,000 in 2006. The effective tax rate was 18.6% in 2007 and
0% in 2006.
Comparison
of the Year Ended December 31, 2006 and 2005
Net
Revenues
Net Product Sales. Net product sales were
$20.4 million in 2006, compared to $15.6 million in
2005, an increase of approximately $4.8 million, or 31%.
Net product sales in 2006 and 2005 related to sales of its
marketed products, including its ALLERX Dose Pack family of
products and DECONSAL and BALACET 325 products. Net product
sales in 2006 also included initial sales of SPECTRACEF. The
increase in net product sales is primarily due to:
|
|
|
a $3.1 million increase in net product sales of ALLERX Dose
Pack family of products as a result of commercial launches of
ALLERX Dose Pack DF in August 2006 and ALLERX Dose Pack PE in
September 2006. In addition, Cornerstone increased the prices of
the ALLERX Dose Pack family of products, ALLERX D and
ALLERX Suspension an average of 16%, 26% and 14%, respectively,
in 2006 as compared to 2005, which offset decreases in unit
volume of these products and resulted in an increase in net
product sales of $750,000.
|
|
|
a $1.3 million increase in net product sales of BALACET 325
due to increased product demand and a full year of sales in
2006, as Cornerstone launched this product in April 2005;
|
|
|
$1.1 million in net product sales of its DECONSAL chewables
as a result of their commercial launch in October 2006; and
|
283
|
|
|
a $272,000 increase in net product sales of SPECTRACEF as a
result of its commercial launch in November 2006.
|
These increases were offset, in part, by a $909,000 decrease in
net product sales of DECONSAL II due to there being sufficient
quantities of product at wholesalers during 2006 due to
purchases by wholesalers that occurred in November 2005 as a
result of a price increase. Cornerstone gave wholesalers a
one-time opportunity to purchase product at the price in effect
prior to the increase. In addition, there was a $584,000
decrease in net product sales of Extendryl, which Cornerstone
licensed to Auriga in May 2005, and a $384,000 decrease in
net product sales of Humibid, which Cornerstone licensed to
Adams in February 2005.
Royalty Agreement Revenues. Royalty agreement
revenues were $1.7 million in 2006, compared to $753,000 in
2005, an increase of approximately $925,000, or 123%. Over
one-half of this increase was due to the royalty agreement
revenues related to APAP 500, which Cornerstone acquired from
Vintage in July 2004 and licensed to Pliva in September 2005. In
addition, Extendryl royalty agreement revenues increased
significantly as a result of increased sales by Auriga.
Collaboration Agreement
Revenues. Collaboration agreement revenues were
$0 in 2006, compared to $1.1 million in 2005. This decrease
results from the February 2006 termination of the co-promotion
agreement with Lupin Pharmaceuticals for Suprax.
Costs and
Expenses
Cost of Product Sales. Cost of product sales
(exclusive of amortization of product rights of
$2.6 million and $1.9 million in 2006 and 2005,
respectively) was $2.2 million in 2006, compared to
$3.4 million in 2005, a decrease of approximately
$1.2 million, or 37%. Gross margin (exclusive of
amortization of product rights of $2.6 million and
$1.9 million in 2006 and 2005, respectively) was 89% in
2006 and 80% in 2005. The profit margin improvement resulted
from effective negotiations with manufacturers regarding product
costs and utilization of bulk product manufacturing and
alternate packaging resources. Cornerstones cost of
product sales in 2006 consisted primarily of expenses associated
with manufacturing and distributing its ALLERX Dose Pack family
of products and its SPECTRACEF, DECONSAL II and BALACET 325
products, and reserves established for excess or obsolete
inventory. Cost of product sales in 2005 consisted primarily of
expenses associated with manufacturing and distributing its
ALLERX Dose Pack family of products and its DECONSAL, BALACET
325 and Extendryl products, and reserves established for excess
or obsolete inventory. In 2006, Cornerstone adjusted its
inventory reserve by $101,000 as a result of packaging as
samples inventory of its BALACET 325 commercial product that had
been reserved in 2005 because it was previously thought to be
unsalable. Cornerstone recorded inventory write-offs of $328,000
in 2005 for excess or obsolete inventory that due to its
expiration dating was not expected to be sold.
Sales and Marketing Expenses. Sales and
marketing expenses were $7.1 million in 2006, compared to
$13.9 million in 2005, a decrease of approximately
$6.8 million, or 49%. The decrease in sales and marketing
expenses in 2006 was primarily due to the January 2006 reduction
in force, which is categorized as follows:
|
|
|
a $1.8 million decrease in labor, benefits and related
employee expenses for sales and marketing personnel;
|
|
|
a $3.8 million decrease in advertising and promotional
expenses;
|
|
|
a $684,000 decrease in travel and related expenses as a result
of the smaller sales team in 2006;
|
|
|
a $300,000 decrease in consulting expenses due to less marketing
research being conducted in 2006; and
|
|
|
a $180,000 decrease in office supplies and related expenses as a
result of the smaller sales team in 2006.
|
Royalty Expenses. Royalty expenses were
$1.7 million in 2006, compared to $1.9 million in
2005, a decrease of approximately $270,000, or 14%. This
decrease was primarily due to lower sales of Cornerstones
BALACET 325, DECONSAL and Extendryl products, offset, in part,
by higher sales of Cornerstones ALLERX Dose Pack family of
products and APAP 500.
284
General and Administrative Expenses. General
and administrative expenses were $3.7 million in 2006,
compared to $4.9 million in 2005, a decrease of
approximately $1.2 million, or 25%. This decrease was
primarily due to a $594,000 decrease in legal and consulting
expenses, $390,000 of bad debt expense recorded in 2005 related
to accounts receivable due from Lupin Pharmaceuticals under the
co-promotion agreement that the parties terminated in 2006, a
$298,000 decrease in expenses related to Cornerstones
defined benefit plan as a result of Cornerstones
termination of the plan in March 2006 and a $104,000 decrease in
labor, benefits and related employee expenses. This decrease was
offset, in part, by a $94,000 increase in Cornerstones
incentive bonus and other compensation expenses and a $110,000
increase in travel expenses.
Research and Development Expenses. Research
and development expenses were $249,000 in 2006, compared to
$266,000 in 2005, a decrease of approximately $17,000, or 6%.
This decrease was primarily due to a $258,000 decrease in
expenses as a result of Cornerstone ceasing development of a
product candidate with the API cephalexin, offset, in part, by a
$231,000 increase primarily related to product development of
the ALLERX family of products.
Amortization and Depreciation
Expenses. Amortization and depreciation expenses
were $2.7 million in 2006, compared to $1.9 million in
2005, an increase of approximately $765,000, or 39%. The
increase in 2006 was primarily due to a full year of
amortization of the BALACET rights, which Cornerstone acquired
in July 2004 and began amortizing in April 2005, and the
acquisition of the SPECTRACEF rights, which Cornerstone acquired
in October 2006 and began amortizing in November 2006.
Other Charges. Other charges were
$3.6 million in 2006, compared to $1.0 million in
2005, an increase of approximately $2.6 million, or 258%.
In 2006, other charges consisted of legal and settlement
expenses of $1.7 million related to litigation with Lupin
Pharmaceuticals, Lupin Ltd. and generic competitors, foregone
merger costs of $240,000 and the forfeiture the Lupin Ltd.
product rights of $1.7 million. In 2005, other charges
consisted of the forfeiture of a standstill payment to Advancis.
The payment allowed Cornerstone to preserve and extend its
rights to purchase a trademark that was to be used upon the
launch of an extended-release cephalexin product. When this
project was abandoned by Cornerstones management at the
end of 2005, the trademark was no longer necessary, and
Cornerstone therefore forfeited the standstill payment.
Other
Expenses
Interest Expense, net. Net interest expense
was $1.2 million in 2006, compared to $1.6 million in 2005,
a decrease of approximately $317,000, or 20%. This decrease was
primarily due to a $224,000 decrease in interest expense related
to the Carolina Note and a decrease of $220,000 in interest
expense related to the Paragon line of credit, offset, in part,
by a $34,000 increase in interest expense related to the
SPECTRACEF license agreement and a $95,000 decrease in the
interest earned on the note receivable from Cornerstone
Biopharma Holdings, Ltd. The decrease in interest expense was
due to a $3.6 million reduction in the principal amount
outstanding under the Carolina Note as a result of a June 2006
agreement whereby Cornerstone and Carolina Pharmaceuticals
agreed to a net offset of $5.4 million in combined
principal and accrued interest outstanding under the Carolina
Note against equal amounts due to Cornerstone from Cornerstone
Biopharma Holdings, Ltd. and Carolina Pharmaceuticals. The
amounts due to Cornerstone primarily resulted from the 2005
Adams litigation settlement.
Liquidity
and Capital Resources
Sources
of Liquidity
From inception in 2004 through 2006, Cornerstone incurred
operating losses, including net losses of $305,000 in 2006 and
$11.4 million in 2005. Cornerstones net income was
approximately $2.5 million in the six months ended
June 30, 2008 and $570,000 in the year ended
December 31, 2007. Cornerstone requires cash to meet its
operating expenses and for capital expenditures, acquisitions
and in-licenses of rights to products and principal and interest
payments on its debt. To date, Cornerstone has funded its
operations primarily from product sales, royalty agreement
revenues and borrowings under the Carolina Note and the Paragon
line of credit. As of June 30, 2008, Cornerstone had
$19,000 in cash and cash equivalents.
285
Cash
Flows
The following table provides information regarding
Cornerstones cash flows for the years ended
December 31, 2007, 2006 and 2005 and the six months ended
June 30, 2008 and 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Year Ended December 31,
|
|
|
Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2008
|
|
|
2007
|
|
|
|
(Audited)
|
|
|
(Unaudited)
|
|
|
|
(In thousands)
|
|
|
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
$
|
1,563
|
|
|
$
|
950
|
|
|
$
|
610
|
|
|
$
|
3,790
|
|
|
|
335
|
|
Investing activities
|
|
|
(718
|
)
|
|
|
(714
|
)
|
|
|
(2,648
|
)
|
|
|
(1,802
|
)
|
|
$
|
(353
|
)
|
Financing activities
|
|
|
(720
|
)
|
|
|
(1,079
|
)
|
|
|
(1,011
|
)
|
|
|
(2,210
|
)
|
|
|
450
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash and cash equivalents
|
|
$
|
125
|
|
|
$
|
(843
|
)
|
|
$
|
(3,049
|
)
|
|
$
|
(222
|
)
|
|
$
|
432
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash
Provided By Operating Activities
Cornerstones primary sources of operating cash flows are
product sales and royalty agreement revenues. Cornerstones
primary uses of cash in its operations are for inventories and
other costs of product sales, sales and marketing expenses,
royalties, general and administrative expenses and interest.
Net cash provided by operating activities in the six months
ended June 30, 2008 primarily reflected Cornerstones
net income of $2.8 million, adjusted by non-cash expenses
totaling $1.1 million and changes in accounts receivable,
inventories, accounts payable accrued expenses and other
operating assets and liabilities. Non-cash items included
amortization and depreciation of $886,000 and stock-based
compensation expense of $169,000. Accounts receivable increased
$3.8 million from December 31, 2007, primarily due to
the launch of the HYOMAX products in May and June 2008.
Inventories increased $661,000 from December 31, 2007,
primarily due to increases in the amount of SPECTRACEF trade
product on hand at June 30, 2008. Accounts payable
increased by $1.1 million from December 31, 2007,
primarily due to increases in amounts payable for
development-related expenses, co-promotion expenses,
professional fees related to Cornerstones proposed merger
with Critical Therapeutics and Aristos inventory purchases.
Accrued expenses increased $2.8 million from
December 31, 2007, primarily due to increases in royalties
and interest payable. Income taxes payable increased $786,000
from December 31, 2007, primarily due to income recognized
during the six months ended June 30, 2008.
Net cash provided by operating activities in the six months
ended June 30, 2007 primarily reflected Cornerstones
net income of $1.0 million, adjusted by non-cash expenses
totaling $2.3 million and changes in accounts receivable,
inventories accrued expenses, income taxes payable and other
operating assets and liabilities. Non-cash items included
amortization and depreciation of $1.7 million and
stock-based compensation expense of $641,000. Accounts
receivable increased $3.0 million from December 31,
2006, primarily due to increased sales of the ALLERX Dose Pack
family of products in February and March 2007. Inventories
increased by $698,000 from December 31, 2006, primarily due
to increases in ALLERX, SPECTRACEF and Aristos trade product on
hand at June 30, 2007. Accrued expenses decreased $286,000
from December 31, 2006, primarily due to increases in sales
allowances and interest accruals, offset, in part, by decreases
in the accrual for litigation settlements due to payments that
occurred during the first quarter if 2007. Income taxes payable
increased $534,000 from December 31, 2006, primarily due to
income recognized during the six months ended June 30, 2007.
Net cash provided by operating activities in 2007 reflected
Cornerstones net income of $570,000, adjusted by non-cash
expenses totaling $4.4 million and changes in accounts
receivable, inventories, accrued expenses and other operating
assets and liabilities. Non-cash items included amortization and
depreciation of $3.2 million, issuance of a warrant for
services of $507,800, stock-based compensation expense of
$293,000 and loss on Cornerstones investment in Auriga
common stock of $324,000. Accounts receivable increased
$4.2 million from December 31, 2006, primarily due to
increased sales at the end of 2007. Inventories increased
$1.2 million from December 31, 2006, primarily due to
stocking and lead time requirements related to the
286
manufacturing of SPECTRACEF. Accrued expenses increased
$1.0 million from December 31, 2006, primarily due to
increased accruals for royalty expenses of $1.5 million and
interest expense of $941,000, offset, in part, by a decrease in
sales allowances of $475,000 and accrued settlement expenses of
$1.1 million.
Net cash provided by operating activities in 2006 reflected
Cornerstones net loss of $305,000, adjusted by non-cash
items totaling $4.1 million and changes in inventories,
accounts payable, accrued expenses and other operating assets
and liabilities. Non-cash items primarily included amortization
and depreciation of $2.7 million, forfeiture of product
rights of $1.7 million related to Cornerstones
settlement agreement with Lupin Pharmaceuticals and Lupin Ltd.
and receipt of shares of Auriga common stock for royalties of
$332,000.
Inventories increased $600,000 from December 31, 2005,
primarily due to stocking and lead time requirements related to
the manufacturing of SPECTRACEF. In addition, Cornerstone
shipped $1.0 million of inventory on behalf of Carolina
Pharmaceuticals in relation to a settlement with
AmerisourceBergen. Accounts payable decreased $1.1 million
from December 31, 2005, primarily due to timing of payments
to vendors. There was a $1.3 million decrease in accrued
expenses resulting from a $1.8 million decrease in accrued
interest outstanding under the Carolina Note, a $705,000
decrease in sales allowances, a $1.1 million decrease in
accrued royalties and a $751,000 decrease in accrued interest,
offset, in part, by a $1.1 million increase in arbitration
settlement accruals. The $1.8 million decrease in accrued
interest under the Carolina Note resulted from the June 2006
agreement between Cornerstone and Carolina Pharmaceuticals to
offset $3.6 million in principal and $1.8 million in
accrued interest outstanding under the Carolina Note against
equal amounts due to Cornerstone from a related party.
Net cash provided by operating activities in 2005 reflected
Cornerstones net loss of $11.4 million, adjusted by
non-cash expenses totaling $2.2 million and changes in
accounts receivable, inventories, accrued expenses and other
operating assets and liabilities. Non-cash items primarily
included amortization and depreciation of $1.9 million and
amortization of debt discount related to a loan with Vintage.
Accounts receivable decreased $1.8 million from
December 31, 2004, primarily due to lower levels of
year-end shipments as compared to the previous year. Inventories
decreased $690,000 from December 31, 2004, primarily due to
lower levels of Humibid inventory after rights to this product
were transferred to Adams in February 2005 as a result of the
January 2005 settlement of litigation. Accrued expenses
increased $7.6 million from December 31, 2004,
primarily due to increases in sales allowances.
Net Cash
Used in Investing Activities
Cornerstones primary sources of cash flows for investing
activities are cash flows from operations and borrowings under
the Paragon line of credit. Cornerstones primary uses of
cash in investing activities are the purchase of property and
equipment and the acquisition and licensing of product rights.
Net cash used in investing activities in the six months ended
June 30, 2008 primarily reflected the purchase of product
rights for $1.8 million.
Net cash used in investing activities in the six months ended
June 30, 2007 primarily reflected net advances to related
parties of $326,000 and the purchase of product rights for
$75,000, offset, in part by the net collection of deposits of
$45,000.
Net cash used in investing activities in 2007 primarily
reflected net advances to related parties of $613,000, purchases
of product rights for $75,000 and purchases of property and
equipment of $64,000, offset, in part, by net proceeds received
from the net collection of deposits of $35,000.
Net cash used in investing activities in 2006 primarily
reflected the purchase of Neos products rights for $500,000, net
advances to related parties of $140,000, the payment for
deposits of $55,000 and purchases of property and equipment of
$57,000.
Net cash used in investing activities in 2005 primarily
reflected payment for Lupin Ltd. product rights of
$1.5 million, net advances to related parties of
$1.1 million and purchases of property and equipment of
$124,000. These amounts were offset, in part, by proceeds from
the release of restricted cash of $68,000.
287
Net Cash
Used in Financing Activities
Cornerstones primary source of cash flows from financing
activities is the Paragon line of credit. Cornerstones
primary uses of cash in financing activities are principal
payments on the Paragon line of credit and the SPECTRACEF
license agreement liability. Uses of cash in financing
activities also included principal payments on a note payable to
Vintage in 2005 and 2006 and the repurchase of a warrant in
connection with a settlement agreement with Lupin
Pharmaceuticals and Lupin Ltd. in 2006.
Net cash used in financing activities in the six months ended
June 30, 2008 reflected net payments on the Paragon line of
credit of $1.8 million and principal payments on the
Carolina Note of $460,000.
Net cash provided by financing activities in the six months
ended June 30, 2007 reflected net proceeds from the Paragon
line of credit of $450,000.
Net cash used in financing activities in 2007 reflected
principal payments on the SPECTRACEF license agreement liability
of $720,000.
Net cash used in financing activities in 2006 primarily
reflected principal payments on the SPECTRACEF license agreement
liability of $250,000, net proceeds from the Paragon line of
credit of $1.3 million, a principal payment on a note
payable to Vintage of $1.5 million and $547,000 related to
the repurchase of a warrant in connection with
Cornerstones settlement agreement with Lupin
Pharmaceuticals and Lupin Ltd.
Net cash used in financing activities in 2005 primarily
reflected a principal payment on a note payable to Vintage of
$1.5 million, offset, in part, by net proceeds from the
Paragon line of credit of $500,000.
Funding
Requirements
Cornerstone expects to continue to incur significant development
and commercialization expenses as it seeks FDA approval for
SPECTRACEF line extensions; advances the development of its
other product candidates, including its methscopolamine and
antihistamine combination and hydrocodone cough suppressant
product candidates; seeks regulatory approvals for its product
candidates that successfully complete clinical testing; and
expands its sales team and marketing capabilities to prepare for
the commercial launch of future products, subject to FDA
approval. Cornerstone also expects to incur additional expenses
to add operational, financial and management information systems
and personnel, including personnel to support its product
development efforts. Accordingly, Cornerstone will need to
increase its revenues to be able to sustain and increase its
profitability on an annual and quarterly basis. There is no
assurance that Cornerstone will be able to do so.
Cornerstones failure to achieve consistent profitability
could impair its ability to raise capital, expand its business,
diversify its product offerings and continue its operations.
Cornerstones future capital requirements will depend on
many factors, including:
|
|
|
the level of product sales of its currently marketed products
and any additional products that Cornerstone may market in the
future;
|
|
|
the scope, progress, results and costs of development activities
for Cornerstones current product candidates;
|
|
|
the costs, timing and outcome of regulatory review of
Cornerstones product candidates;
|
|
|
the number of, and development requirements for, additional
product candidates that Cornerstone pursues;
|
|
|
the costs of commercialization activities, including product
marketing, sales and distribution;
|
|
|
the costs and timing of establishing manufacturing and supply
arrangements for clinical and commercial supplies of
Cornerstones product candidates and products;
|
|
|
the extent to which Cornerstone acquires or invests in products,
businesses and technologies;
|
|
|
the extent to which Cornerstone chooses to establish
collaboration, co-promotion, distribution or other similar
arrangements for its marketed products and product
candidates; and
|
288
|
|
|
the costs of preparing, filing and prosecuting patent
applications and maintaining, enforcing and defending claims
related to intellectual property owned by or licensed to
Cornerstone.
|
To the extent that Cornerstones capital resources are
insufficient to meet its future capital requirements,
Cornerstone will need to finance its cash needs through public
or private equity offerings, debt financings, corporate
collaboration and licensing arrangements or other financing
alternatives. Cornerstones only committed external source
of funds is borrowing availability under the Paragon line of
credit, which is personally guaranteed by Cornerstones
President and Chief Executive Officer and Carolina
Pharmaceuticals, Inc., a company under common control with
Cornerstone, as described in more detail below under
Debt Financing Paragon Line of
Credit. Cornerstones ability to borrow under the
Paragon line of credit is subject to its satisfaction of
specified conditions. Additional equity or debt financing, or
corporate collaboration and licensing arrangements, may not be
available on acceptable terms, if at all.
As of June 30, 2008, Cornerstone had approximately $19,000
of cash and cash equivalents on hand and borrowing availability
of $3.9 million under the Paragon line of credit. Based on
its current operating plans, Cornerstone believes that its
existing cash and cash equivalents, revenues from product sales
and borrowing availability under the Paragon line of credit are
sufficient to continue to fund its existing level of operating
expenses and capital expenditure requirements as a standalone
company for the foreseeable future.
Debt
Financing
Carolina Note. In April 2004, Cornerstone
entered into the Carolina Note with Carolina Pharmaceuticals to
borrow up to $15.0 million for five years with an annual
interest rate of 10%. Cornerstone borrowed $13.0 million
under the Carolina Note in April 2004. In June 2006, Cornerstone
and Carolina Pharmaceuticals agreed to offset $3.6 million
in principal and $1.8 million in accrued interest
outstanding under the Carolina Note against equal amounts due to
Cornerstone from a related party. As of June 30, 2008,
there was $9.0 million in principal and $2.0 million
in accrued interest outstanding under Carolina Note. In
connection with the merger agreement, Carolina Pharmaceuticals,
Cornerstone and Critical Therapeutics entered into a noteholder
agreement that provides, among other things, for the conversion
or exchange of the outstanding principal amount of the Carolina
Note into shares of Cornerstones common stock prior to the
effective time of the merger.
Paragon Line of Credit. In April 2005,
Cornerstone obtained financing under a bank line of credit for
up to $4.0 million with Paragon Commercial Bank.
Cornerstone has used the Paragon line of credit to fund its
general operations and product acquisitions. As amended and
renewed in June 2008, the Paragon line of credit is subject to a
monthly borrowing base equal to 75% of Cornerstones
accounts receivable balances outstanding 90 days or less
and 100% of the $500,000 assignment of deposits to Cornerstone
by Cornerstones President and Chief Executive Officer. As
of June 30, 2008, there were no amounts outstanding under
the Paragon line of credit and $3.9 million in available
borrowing capacity. Cornerstone is currently considering
financing alternatives to fund capital expenditures in the
future.
Amounts outstanding under the Paragon line of credit bear
interest at a variable rate equal to the Wall Street Journal
prime rate, which was 5.00% as of June 30, 2008. The
Paragon line of credit is collateralized by Cornerstones
accounts receivable, inventories, intangible assets, other
personal property, a $2.0 million deed of trust on the
personal residence of Cornerstones President and Chief
Executive Officer and an assignment of deposits in the amount of
$500,000 to Cornerstone by Cornerstones President and
Chief Executive Officer. Cornerstones President and Chief
Executive Officer and Carolina Pharmaceuticals, Inc., a company
under common control with Cornerstone, have jointly guaranteed
the Paragon line of credit. The Paragon line of credit requires,
among other requirements, that the Carolina Note be subordinated
to the Paragon line of credit, that Cornerstone not incur any
additional debt without Paragons consent and that
Cornerstones President and Chief Executive Officer
maintains a certain level of liquid assets and a majority
ownership in Cornerstone. Interest is due monthly with all
outstanding principal due on maturity in June 2009.
289
Contractual
Obligations
The following table summarizes Cornerstones known fixed
contractual obligations as of December 31, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
Less Than
|
|
|
1-3
|
|
|
3-5
|
|
|
More Than
|
|
Contractual Obligations
|
|
Total
|
|
|
1 Year
|
|
|
Years
|
|
|
Years
|
|
|
5 Years
|
|
|
|
(In thousands)
|
|
|
Long-term debt obligations(1)
|
|
$
|
12,653
|
|
|
|
1,750
|
|
|
|
10,903
|
|
|
|
|
|
|
|
|
|
Capital lease obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease obligations(2)
|
|
|
333
|
|
|
|
262
|
|
|
|
71
|
|
|
|
|
|
|
|
|
|
Purchase obligations(3)
|
|
|
6,704
|
|
|
|
3,302
|
|
|
|
2,202
|
|
|
|
1,200
|
|
|
|
|
|
Other long-term liabilities reflected on Cornerstones
balance sheet under GAAP(4)
|
|
|
4,750
|
|
|
|
1,000
|
|
|
|
2,250
|
|
|
|
1,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations
|
|
$
|
24,440
|
|
|
|
6,314
|
|
|
|
15,426
|
|
|
|
2,700
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Long-term debt obligations include principal and interest due
under the Paragon line of credit and the Carolina Note. See
Notes 4 and 5 to Cornerstones consolidated financial
statements beginning on
page F-71
of this proxy statement/prospectus for a description of the
amounts due under the Paragon line of credit and the Carolina
Note, respectively. In April 2008, Cornerstone paid down
$460,000 of principal under the Carolina Note. |
|
(2) |
|
Operating leases include minimum payments under leases for
Cornerstones facilities, automobiles and certain
equipment. In May 2008, Cornerstone entered into a lease
agreement for a new corporate headquarters. Cornerstones
minimum lease payments under the lease agreement are $259,000 in
2009, $295,000 in 2010, $302,000 in 2011, $310,000 in 2012 and
$1.2 million thereafter. |
|
(3) |
|
Purchase obligations include fixed or minimum payments under
manufacturing and supply agreements with third-party
manufacturers; clinical trial and research agreements with
contract research organizations and consultants; and agreements
with providers of marketing analytical services. Cornerstone and
Meiji entered into a verbal agreement to expand the scope of the
license and supply agreement in August 2008, and the parties are
currently negotiating a written addendum to the license and
supply agreement, which is expected to supercede the verbal
agreement in September 2008. Under the current draft of the
written addendum, Cornerstones aggregate annual combined
purchases of API, SPECTRACEF 200 mg, SPECTRACEF 400 mg
and sample packs of SPECTRACEF 400 mg must exceed
$15.0 million during the first year after either SPECTRACEF
200 mg or SPECTRACEF 400 mg manufactured by Meiji is
commercially launched, $20.0 million during the second
year, $25.0 million during the third year,
$30.0 million during the fourth year and $35.0 million
during the fifth year. In determining the purchase obligations
due to Meiji for purposes of the contractual obligations table,
Cornerstone used the price for cefditoren pivoxil in effect on
December 31, 2007. Purchase obligations do not include any
contingent contractual payments that Cornerstone may be required
to make that depend on the achievement of scientific, regulatory
or commercial milestones, or any contingent contractual royalty
payments. |
|
(4) |
|
Other long-term liabilities include principal and interest due
under Cornerstones license agreement liability with Meiji.
See Note 3 to Cornerstones consolidated financial
statements beginning on
page F-70
of this proxy statement/prospectus for a description of the
amounts due under the license agreement liability. |
In connection with a noteholder agreement entered into by
Cornerstone, Carolina Pharmaceuticals and Critical Therapeutics
in connection with Cornerstones merger with Critical
Therapeutics, Cornerstone is required to repay the Carolina Note
prior to the closing of the merger by converting the principal
amount outstanding under the Carolina Note into shares of
Cornerstone common stock. Cornerstone anticipates that all
accrued interest under the Carolina Note will be paid in cash at
or prior to the time the principal amount outstanding under the
Carolina Note is converted.
290
Off-Balance
Sheet Arrangements
Since inception, Cornerstone has not engaged in any off-balance
sheet arrangements, including structured finance, special
purpose entities or variable interest entities.
Effects
of Inflation
Cornerstone does not believe that inflation has had a
significant impact on its revenues or results of operations
since inception. Cornerstone expects its cost of product sales
and other operating expenses will change in the future in line
with periodic inflationary changes in price levels. Because
Cornerstone intends to retain and continue to use its property
and equipment, Cornerstone believes that the incremental
inflation related to the replacement costs of such items will
not materially affect its operations. However, the rate of
inflation affects Cornerstones expenses, such as those for
employee compensation and contract services, which could
increase its level of expenses and the rate at which it uses its
resources. While Cornerstones management generally
believes that Cornerstone will be able to offset the effect of
price-level changes by adjusting its product prices and
implementing operating efficiencies, any material unfavorable
changes in price levels could have a material adverse affect on
Cornerstones financial condition, results of operations
and cash flows.
Recent
Accounting Pronouncements
In May 2008, the FASB issued SFAS No. 162, The
Hierarchy of Generally Accepted Accounting Principles, or
SFAS 162. SFAS 162 identifies the sources of
accounting principles and the framework for selecting the
principles to be used in the preparation of financial statements
of nongovernmental entities that are presented in conformity
with GAAP, or the GAAP hierarchy. SFAS 162 makes the GAAP
hierarchy explicitly and directly applicable to preparers of
financial statements, a step that recognizes preparers
responsibilities for selecting the accounting principles for
their financial statements, and sets the stage for making the
framework of FASB Concept Statements fully authoritative. The
effective date for SFAS 162 is 60 days following the
SECs approval of the Public Company Accounting Oversight
Boards related amendments to remove the GAAP hierarchy
from auditing standards, where it has resided for some time.
Cornerstone does not expect the adoption of SFAS 162 to
have a material impact on its financial statements.
In April 2008, the FASB issued FASB Staff Position Financial
Accounting Standard
142-3,
Determination of the Useful Life of Intangible Assets, or
FSP
FAS 142-3.
FSP
FAS 142-3
amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful
life of a recognized intangible asset under SFAS 142,
Goodwill and Other Intangible Assets. In developing
assumptions about renewal or extension, FSP
FAS 142-3
requires an entity to consider its own historical experience or,
if it has no experience, market participant assumptions,
adjusted for the entity-specific factors in paragraph 11 of
SFAS 142. FSP
FAS 142-3
expands the disclosure requirements of SFAS 142 and is
effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods
within those fiscal years, with early adoption prohibited. The
guidance for determining the useful life of a recognized
intangible asset must be applied prospectively to intangible
assets acquired after the effective date. The disclosure
requirements must be applied prospectively to all intangible
assets recognized as of, and subsequent to, the effective date.
Cornerstone does not expect the adoption of FSP
FAS 142-3
to have a material impact on its financial statements.
In November 2007, the EITF issued
EITF 07-01,
which requires collaborators to present the results of
activities for which they act as the principal on a gross basis
and report any payments received from or made to other
collaborators based on other applicable generally accepted
accounting principles or, in the absence of other applicable
generally accepted accounting principles, based on analogy to
authoritative accounting literature or a reasonable, rational
and consistently applied accounting policy election.
EITF 07-01
is effective for fiscal years beginning after December 15,
2008. Cornerstone does not expect the adoption of
EITF 07-01
to have a material impact on its financial statements.
In June 2007, the EITF issued
EITF 07-3,
which concludes that non-refundable advance payments for future
research and development activities should be deferred and
capitalized until the goods have been delivered or the related
services have been performed. If an entity does not expect the
goods to be delivered or services to be rendered, the
capitalized advance payments should be charged to expense.
EITF 07-3
is effective for fiscal
291
years beginning after December 15, 2007. The initial
adjustment to reflect the effect of applying this EITF as a
change in accounting principle is accounted for as a
cumulative-effect adjustment to retained earnings as of the
beginning of the year of adoption. The adoption of
EITF 07-03
did not have a material impact on Cornerstones financial
statements.
In December 2007, the FASB issued SFAS 141(R), which
requires the acquiring entity in a business combination to
record all assets acquired and liabilities assumed at their
respective acquisition-date fair values and changes other
practices under SFAS 141, some of which could have a
material impact on how an entity accounts for its business
combinations. SFAS 141(R) also requires additional
disclosure of information surrounding a business combination so
that users of the entitys financial statements can fully
understand the nature and financial impact of the business
combination. SFAS 141(R) is effective for fiscal years
beginning after December 15, 2008 and is applied
prospectively to business combinations for which the acquisition
date is on or after January 1, 2009. The provisions of
SFAS 141(R) will only impact Cornerstones financial
statements if Cornerstone is a party to a business combination
after the effective date of the pronouncement.
In December 2007, the FASB issued SFAS 160, which requires
entities to report non-controlling minority interests in
subsidiaries as equity in consolidated financial statements.
SFAS 160 is effective for fiscal years beginning on or
after December 15, 2008. SFAS 160 is applied
prospectively as of the beginning of the fiscal year in which it
is initially applied, except for presentation and disclosure
requirements, which are applied retrospectively for all periods
presented. Cornerstone does not expect the adoption of
SFAS 160 to have a material impact on its financial
statements.
In February 2007, the FASB issued SFAS 159, which permits
companies to choose to measure many financial instruments and
certain other items at fair value. It also establishes
presentation and disclosure requirements designed to facilitate
comparisons between companies that choose different measurement
attributes for similar types of assets and liabilities.
SFAS 159 requires companies to provide additional
information that will help investors and other users of
financial statements to more easily understand the effect of a
companys choice to use fair value on its earnings. It also
requires companies to display the fair value of those assets and
liabilities for which they have chosen to use fair value on the
face of the balance sheet. SFAS 159 is effective for fiscal
years beginning after November 15, 2007 and interim periods
within those fiscal years. Cornerstone was required to adopt
SFAS 159 on January 1, 2008. The adoption of
SFAS 159 did not have a material impact on
Cornerstones financial statements.
In September 2006, the FASB issued SFAS 157, which defines
fair value, establishes a framework for measuring fair value in
GAAP and expands disclosures about fair value measurements. In
February 2008, the FASB issued
FSP 157-2,
which defers the effective date of applying the provisions of
SFAS 157 to the fair value measurement of nonfinancial
assets and nonfinancial liabilities until fiscal years beginning
after November 15, 2008. Cornerstone adopted the provisions
of SFAS 157 that pertain to financial assets and
liabilities on January 1, 2008. The adoption of
SFAS 157 did not have a material impact on
Cornerstones financial statements. Cornerstone is
currently evaluating the effect
FSP 157-2
will have on its financial statements.
In July 2006, the FASB issued Interpretation No. 48,
Accounting for Uncertainty in Income Taxes an
interpretation of FASB Statement No. 109, or
FIN 48. FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in an enterprises
financial statements in accordance with SFAS No. 109
and prescribes a recognition threshold and measurement attribute
for the financial statement recognition and measurement of a tax
position taken or expected to be taken in a tax return.
FIN 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim
periods, disclosure and transition. FIN 48 is effective for
fiscal years beginning after December 15, 2006. The
adoption of FIN 48 did not have a material impact on
Cornerstones financial statements.
292
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT
CORNERSTONES MARKET RISK
Cornerstones primary market risk exposure is related to
changes in interest rates. Cornerstone does not hedge its
interest rate exposure. As of June 30, 2008,
Cornerstones exposure to market risk for a change in
interest rates is related solely to debt outstanding under the
Paragon line of credit, which is used for working capital
purposes and which bears a variable interest rate equal to the
Wall Street Journal prime rate (5.00% as of June 30, 2008).
As of June 30, 2008, there was $3.9 million of
borrowing availability under the Paragon line of credit but no
outstanding balance. The extent of Cornerstones interest
rate risk under this term loan is not quantifiable or
predictable because of the variability of future interest rates
and business financing requirements. However, if Cornerstone
were to borrow the full $3.9 million available under the
Paragon line of credit as of June 30, 2008, an increase in
the Wall Street Journal prime rate of 100 basis points
would increase Cornerstones annualized interest expense by
less than $40,000.
293
MANAGEMENT
FOLLOWING THE MERGER
Executive
Officers and Directors
Upon consummation of the merger, the board of directors of the
combined company will be comprised of five members classified
into three classes. The following table lists the names, ages
and positions as of September 15, 2008 of individuals
currently expected to serve as directors and executive officers
of the combined company upon consummation of the merger.
Following the effective time of the merger, Critical
Therapeutics board of directors will remain divided into
three classes, with one class being elected each year and
members of each class holding office for a three-year term.
|
|
|
|
|
|
|
Name
|
|
Age
|
|
Position with the Combined Company
|
|
Craig A. Collard
|
|
|
42
|
|
|
President, Chief Executive Officer and Director(1)
|
Chenyqua Baldwin
|
|
|
42
|
|
|
Vice President, Finance, Chief Accounting Officer
and Controller
|
Christopher Codeanne
|
|
|
40
|
|
|
Director (2)
|
Brian Dickson, M.D.
|
|
|
57
|
|
|
Chief Medical Officer
|
Michael Enright
|
|
|
46
|
|
|
Director (2)
|
George Esgro
|
|
|
47
|
|
|
Vice President, Sales and Marketing
|
Michael Heffernan
|
|
|
44
|
|
|
Director (3)
|
Steven M. Lutz
|
|
|
41
|
|
|
Executive Vice President, Manufacturing and Trade
|
Alastair McEwan
|
|
|
53
|
|
|
Director (3)
|
David Price
|
|
|
46
|
|
|
Executive Vice President, Finance, and Chief Financial
Officer
|
Scott B. Townsend, Esq.
|
|
|
41
|
|
|
General Counsel, Executive Vice President of Legal
Affairs and Secretary
|
|
|
|
(1) |
|
Class I director, whose term will expire at the 2011 annual
meeting of stockholders. |
|
(2) |
|
Class II director, whose term will expire at the 2009
annual meeting of stockholders. |
|
(3) |
|
Class III director, whose term will expire at the 2010
annual meeting of stockholders. |
Executive
Officers
Craig A. Collard will serve as President and Chief
Executive Officer of the combined company. Mr. Collard
founded Cornerstone in March 2004 and has since served as its
President and Chief Executive Officer and a director. Prior to
Cornerstone, Mr. Collard served as the President and Chief
Executive Officer of Carolina Pharmaceuticals, Inc., a company
he founded in May 2003. Prior to founding Carolina
Pharmaceuticals, Inc., Mr. Collard served as Vice President
of Sales for Verum Pharmaceuticals Inc., or Verum, a specialty
pharmaceutical company in Research Triangle Park, North Carolina
from August 2002 to February 2003. From 1998 to 2002,
Mr. Collard worked as Director of National Accounts at DJ
Pharma, Inc., a company which was eventually purchased by
Biovail Pharmaceuticals, Inc., or Biovail. His pharmaceutical
career began in 1992 as a field sales representative at Dura
Pharmaceuticals, Inc., or Dura. He was later promoted to several
other sales and marketing positions within Dura.
Mr. Collard sits on the board of directors of Hilltop Home
Foundation, a Raleigh, North Carolina, non-profit corporation,
in addition to the board of directors of Cornerstone.
Mr. Collard holds a B.S. in Engineering from the Southern
College of Technology.
Chenyqua Baldwin will serve as Chief Accounting Officer,
Controller and Vice President of Finance of the combined
company. Ms. Baldwin is a founding stockholder of
Cornerstone and has served as the Vice President of Finance
since August 2004. Prior to Cornerstone, Ms. Baldwin served
as Vice President of Finance for Carolina Pharmaceuticals, Inc.
from January 2004 to August 2004. Ms. Baldwin also held the
positions of Director of Finance and Director of Accounting with
Biovail Pharmaceuticals Inc., the domestic sales and marketing
division of Biovail Corporation, from February 2001 to January
2004. Ms. Baldwin holds
294
a Masters of Accounting and B.S. in Business Administration from
the University of North Carolina at Chapel Hill.
Brian Dickson, M.D. will serve as Chief Medical
Officer of the combined company. Dr. Dickson has served as
the Chief Medical Officer of Cornerstone since May 2005. He
joined Cornerstone after serving as the Chief Medical Officer at
Inveresk Research Group Inc., or Inveresk, from May 2004 until
December 2004. Prior to Inveresk, he served as Chief Medical
Officer at the contract research organization, Covalent Group
Inc. (now Encorium) from 2001 to 2003. Dr. Dickson also has
worked in senior management with Smith, Kline & French
Laboratories Ltd. from 1978 to 1987, Searle from 1988 to 1991,
and Warner Lambert / Parke Davis from 1991 to 1994. In
addition to Dr. Dicksons industry experience, he is a
past
Editor-in-Chief
of the Journal of Pharmaceutical Medicine and is a member of the
Faculty of Pharmaceutical Medicine. Dr. Dickson received
his Doctor of Medicine from Adelaide University in South
Australia.
George Esgro will serve as Vice President of Sales and
Marketing of the combined company. Mr. Esgro has served as
Cornerstones Vice President of Sales and Marketing since
March 2008. Prior to Cornerstone, Mr. Esgro served as
Regional Director for Roche Biomedical Laboratories, Inc, a
network of clinical laboratories, from June 2006 to January
2008. From August 2005 to April 2006, Mr. Esgro served as
the Vice President of Sales and Training for Millenium
Pharmaceuticals, Inc., a biopharmaceutical company.
Mr. Esgro served as Senior National Sales Director for
Amgen, Inc., or Amgen, a biotechnology company, from December
2001 to August 2005. Before Amgen, Mr. Esgro held senior
management and executive roles with GlaxoSmithKline from May
1988 through September 2001. Mr. Esgro holds a B.A. in
Business from James Madison University.
Steven M. Lutz will serve as Executive Vice President of
Manufacturing and Trade of the combined company. Mr. Lutz
is a founding stockholder of Cornerstone and has served as
Executive Vice President of Commercial Operations since March
2004. Prior to Cornerstone, Mr. Lutz served as Vice
President of Corporate Accounts for Carolina Pharmaceuticals,
Inc. from July 2003 to August 2004. In previous positions,
Mr. Lutz was responsible for Trade Sales for Verum from
September 2002 to February 2003, was a National Account Manager
for Biovail from February 2001 to September 2002 and Roberts
Pharmaceuticals Inc. (later acquired by Shire U.S.) from January
1995 to February 2001. Mr. Lutz holds a B.A. in Political
Science and Sociology from Moravian College in Bethlehem,
Pennsylvania.
David Price will serve as Executive Vice President,
Finance, and Chief Financial Officer of the combined company.
Prior to his joining Cornerstone on September 8, 2008 in those
same positions, he served as a Managing Director for Jefferies
& Company, Inc, an investment banking firm, since April
2006 in the Specialty Pharmaceutical and Pharmaceutical Services
investment banking practice. From September 2000 to March 2006,
Mr. Price served as a Managing Director for Bear, Stearns &
Co. Inc., an investment banking firm, in London and in New York.
He worked for Arthur Andersen & Co., an accounting firm, as
an Audit Assistant from 1984 to 1987 and as an Audit Senior
Manager and Corporate Finance Manager for Price Waterhouse, an
accounting firm, in London and Los Angeles from 1987 to 1993.
From 1993 to 1997, Mr. Price served as Mergers and
Acquisitions Director for Lex Service PLC, an automotive
services provider, and he was the Director of the Merger
Integration Practice of PriceWaterhouseCoopers Consulting from
1997 to 2000. Mr. Price qualified as a Chartered Accountant in
1987 with the Institute of Chartered Accountants in England and
Wales and holds an Honours degree in Accounting and Financial
Management from Lancaster University, Lancaster,
United Kingdom.
Scott B. Townsend, Esq. will serve as General
Counsel, Executive Vice President of Legal Affairs and Secretary
of the combined company. He has served as Critical
Therapeutics Senior Vice President of Legal Affairs since
March 2007, as its General Counsel since June 2006 and as its
Secretary since September 2004. Mr. Townsend served as
Critical Therapeutics Vice President of Legal Affairs from
August 2004 to March 2007. From August 2000 to August 2004,
Mr. Townsend was employed by the law firm Wilmer Cutler
Pickering Hale and Dorr LLP (formerly known as Hale and Dorr
LLP) as a junior partner from May 2002 to August 2004 and as an
associate from August 2000 to May 2002. Mr. Townsend was an
associate with the law firm Kilpatrick Stockton LLP in
Charlotte, North Carolina from July 1999 to July 2000 and an
associate with the law firm Goodwin Procter LLP in Boston,
Massachusetts from September 1997 to July 1999.
295
Mr. Townsend holds an A.B. in Economics and Government from
Bowdoin College and a J.D. from The University of Virginia
School of Law.
Directors
Craig A. Collard will serve on the combined
companys board of directors immediately following
consummation of the merger. His biographical information is
included under the heading Executive Officers
immediately above in this proxy statement/prospectus.
Christopher Codeanne will serve on the combined
companys board of directors immediately following
consummation of the merger. Mr. Codeanne has served since
April 2008 as Chief Operating Officer and Chief Financial
Officer of Oncology Development Partners, LLC (d/b/a
Oncopartners), a specialized international oncology contract
research organization. Mr. Codeanne served as the Chief
Financial Officer of Averion International Corp., a
publicly-traded international contract research organization,
from December 2006 through April 2008. Prior to Averion, from
2002 through July 2006, Mr. Codeanne was the Chief
Financial Officer of SCIREX Corporation LLC, now Premier
Research Group plc, an international, full-service contract
research organization. From 1999 to 2002, Mr. Codeanne was
Director of Finance of SCIREX. Mr. Codeanne holds a B.A. in
Accounting from Fairfield University and an MBA from the
University of Connecticut. Mr. Codeanne is also a member of
the American Institute of Certified Public Accountants,
Connecticut Society of Certified Public Accountants and
Financial Executives International.
Michael Enright will serve on the combined companys
board of directors immediately following consummation of the
merger. Since 1995, Mr. Enright has served as Chief
Financial Officer for Atlantic Search Group, Inc., a staff
augmentation and functional outsourcing services organization
serving pharmaceutical companies and contract research
organizations in the United States and India. Prior to 1995,
Mr. Enright held positions in employee benefits
administration with Hauser Insurance Group and The Prudential
Insurance Company and in financial management with General
Electric Companys aerospace business group.
Mr. Enright holds a B.A. in Finance from Villanova
University and an M.B.A. from the Kenan Flagler School of
Business of University of North Carolina at Chapel Hill.
Michael Heffernan will serve on the combined
companys board of directors immediately following
consummation of the merger. Mr. Heffernan is a co-founder
and has served as President and Chief Executive Officer of
Collegium Pharmaceutical, Inc., or Collegium, since 2002.
Collegium Pharmaceutical is a specialty pharmaceutical company
that develops and commercializes products to treat central
nervous system, respiratory and skin-related disorders. Prior to
Collegium Mr. Heffernan served as President and Chief
Executive Officer of Clinical Studies Ltd., a pharmaceutical
clinical development company, from 1995 to 1999. In previous
positions, Mr. Heffernan served as President and Chief
Executive Officer of PhyMatrix Corp., an integrated health care
services company, from 1999 to 2001, and filled sales and
marketing positions with Eli Lilly & Company.
Mr. Heffernan also has served on the board of directors of
TyRx Pharma, Inc. since 2002. Mr. Heffernan holds a B.S. in
Pharmacy from the University of Connecticut and is a Registered
Pharmacist.
Alastair McEwan will serve on the combined companys
board of directors immediately following consummation of the
merger. Mr. McEwan joined Cornerstones board of
directors in August 2005 and has served as Chairman of the board
of directors since January 2006. From October 2005 through
December 2005, Mr. McEwan acted as Cornerstones
interim Chief Financial Officer. Prior to working with
Cornerstone, Mr. McEwan was a Group Executive Vice
President of Inveresk Research Group, Inc. and served as
President of Inveresk Global Clinical Operations beginning in
2003. He had previously been President of Inveresk Clinical
Americas operations beginning in April 2001. From January 2000
until March 2001, Mr. McEwan was Head of Corporate
Development of Inveresk Research Group focusing on mergers and
acquisitions, and served as General Manager, Clinical, of
Inveresk Research Group Limited from June 1996 until December
1999. Mr. McEwan served as a member of the Group Executive
Board of Inveresk Research Group, Inc. from 1999 to 2004.
Mr. McEwan sits on the board of Averion International
Corp., a publicly-traded international contract research
organization, in addition to the board of Cornerstone.
Mr. McEwan qualified as a Chartered
296
Accountant in 1979 with the Institute of Chartered Accountants
of Scotland and holds a Bachelor of Commerce from the University
of Edinburgh.
The Board
of Directors
Board
Composition
The combined companys board of directors will initially be
composed of five directors, three of whom will be independent of
management. The terms of office of the directors will be divided
into three classes:
|
|
|
|
|
Class I, whose term will expire at the 2011 annual meeting
of stockholders;
|
|
|
|
Class II, whose term will expire at the 2009 annual meeting
of stockholders; and
|
|
|
|
Class III, whose term will expire at the 2010 annual
meeting of stockholders.
|
Upon the consummation of the merger, Class I will consist
of Mr. Collard, Class II will consist of
Mr. Codeanne and Mr. Enright, and Class III will
consist of Mr. McEwan and Mr. Heffernan. Pursuant to
the bylaws of Critical Therapeutics, the board of directors may
appoint from its members a Chairman. Mr. Collard is
expected to be appointed as Chairman of the board of directors.
In that case, because the Chairman of the board of directors
will not be an independent director, Cornerstone expects that
the board of directors will designate a Lead Independent
Director at the first meeting of the board of directors. The
Lead Independent Director will be responsible for presiding over
the executive sessions of the independent directors, ensuring
proper information flow to all outside directors, and any other
functions that may be specified to the position.
Board
Committees
The combined company will have an audit committee, a
compensation committee and a nominating and corporate governance
committee. The members of each committee will be appointed by
the combined companys board of directors, upon
recommendation of the nominating and corporate governance
committee, and serve one-year terms. Each of these committees
will operate under a charter that has been approved by the board
of directors.
The Audit
Committee
The Audit Committees responsibilities will include:
|
|
|
|
|
appointing, approving the compensation of, and assessing the
independence of the combined companys registered public
accounting firm;
|
|
|
|
overseeing the work of the combined companys independent
registered public accounting firm, including through the receipt
and consideration of reports from the independent registered
public accounting firm;
|
|
|
|
reviewing and discussing with management and the independent
registered public accounting firm the combined companys
annual and quarterly financial statements and related
disclosures;
|
|
|
|
monitoring the combined companys internal control over
financial reporting, disclosure controls and procedures and code
of business conduct and ethics;
|
|
|
|
establishing policies regarding hiring employees from the
independent registered public accounting firm and procedures for
the receipt and retention of accounting-related complaints and
concerns;
|
|
|
|
meeting independently with the combined companys
independent registered public accounting firm and management to
discuss the combined companys financial statements, and
other financial reporting and audit matters;
|
|
|
|
preparing the audit committee report required by SEC
rules; and
|
|
|
|
reviewing and approving or ratifying related person transactions.
|
297
The members of the Audit Committee will be Mr. Codeanne,
Mr. Enright and Mr. Heffernan. Mr. Codeanne will
serve as chair of the Audit Committee. Cornerstone expects that
the combined company board of directors will determine that
Mr. Codeanne is an audit committee financial
expert as defined by applicable SEC rules.
The
Compensation Committee
The Compensation Committees responsibilities will include:
|
|
|
|
|
reviewing and making recommendations to the board of directors
regarding the compensation of the combined companys
executive officers;
|
|
|
|
overseeing the evaluation of the combined companys senior
executives;
|
|
|
|
reviewing and making recommendations to the board of directors
regarding incentive compensation and equity-based plans;
|
|
|
|
administering the combined companys stock incentive plans;
|
|
|
|
reviewing and making recommendations to the board of directors
regarding director compensation;
|
|
|
|
reviewing and discussing with management the combined
companys Compensation Discussion and Analysis; and
|
|
|
|
preparing the compensation committee report required by SEC
rules.
|
The members of the Compensation Committee will be
Mr. Heffernan and Mr. Enright. Mr. Heffernan will
serve as chair of the Compensation Committee.
The
Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committees
responsibilities will include:
|
|
|
|
|
identifying individuals qualified to become board members;
|
|
|
|
recommending to the board of directors the persons to be
nominated for election as directors and to each of the board of
directors committees;
|
|
|
|
reviewing and making recommendations to the board of directors
with respect to management succession planning;
|
|
|
|
developing and recommending to the board of directors corporate
governance principles; and
|
|
|
|
overseeing an annual evaluation of the board of directors.
|
The members of the Nominating and Corporate Governance Committee
will be Mr. Enright and Mr. Codeanne. Mr. Enright
will serve as chair of the Nominating and Corporate Governance
Committee.
Compensation
of Directors
The policy of the combined company with respect to the
compensation of directors is expected to be determined at the
first meeting of the board of directors following the
consummation of the merger.
Certain
Relationships and Related Transactions, and Director
Independence
Transactions
with Related Persons
Employment
and Related Agreements
Cornerstone and Critical Therapeutics have entered into
employment and related agreements with certain of their
executive officers who will become executive officers of the
combined company. For more information regarding these
employment agreements, please see the section Interests of
Cornerstones Directors and Executive Officers in the
Merger Employment and Related Agreements
beginning on page 128 of this proxy
statement/prospectus and the section Interests of Critical
Therapeutics Directors and Executive
298
Officers in the Merger Employment Agreements
beginning on page 120 of this proxy statement/prospectus.
Employment
Arrangement with Mr. McEwan
In addition to serving as a director, Mr. McEwan has served
as an employee of Cornerstone providing strategic, management,
financial and corporate governance advice to Cornerstone. In
connection with his service as an employee of Cornerstone in
2007, Mr. McEwan received $30,000 in cash compensation and
$12,813 in benefits including health insurance, life insurance
and long-term disability insurance.
Other
Related Party Transactions
In April 2004, Cornerstone entered into the Carolina Note, an
unsecured loan agreement with Carolina Pharmaceuticals, whereby
Cornerstone could borrow up to $15.0 million at 10%
interest for five years. Because Mr. Collard is the Chief
Executive Officer and Chairman of Carolina Pharmaceuticals, he
is a control person of Carolina Pharmaceuticals. In addition,
Ms. Baldwin and Mr. Lutz are each directors of Carolina
Pharmaceuticals. Cornerstone borrowed $13.0 million under
the Carolina Note in April 2004. In June 2006, Cornerstone
entered into a note amendment and waiver agreement that provided
for the offset of approximately $3.6 million in principal
and $1.8 million in accrued interest outstanding under the
Carolina Note against equal amounts due to Cornerstone from
Cornerstone Biopharma Holdings, Ltd. and Carolina
Pharmaceuticals. The amounts due to Cornerstone primarily
resulted from the 2005 Adams litigation settlement. As of
December 31, 2007 and 2006, approximately $9.4 million
in principal was outstanding under the Carolina Note plus
approximately $549,000 and $1.5 million in accrued
interest, respectively. On April 11, 2008, Cornerstone made
a principal payment of $460,000 on the Carolina Note. The
outstanding principal and accrued interest are due in 2009. As
of September 15, 2008, the outstanding principal amount of
the Carolina Note was approximately $9.0 million.
Carolina Pharmaceuticals, which is the holder of the Carolina
Note, has entered into an agreement that provides, among other
things, for the exchange or conversion of the outstanding
principal amount of the Carolina Note into shares of
Cornerstones common stock prior to the effective time of
the merger and for the same voting and
lock-up
provisions provided pursuant to the agreements entered into by
Cornerstones other stockholders.
From time to time, Mr. Collard has been provided with certain
salary advances from Cornerstone. Since January 1, 2005,
the total amount of such advances has been approximately
$2.65 million, comprised of approximately $10,000,
$615,000, $1.1 million and $946,000 in 2008, 2007, 2006 and
2005, respectively. Mr. Collard repaid all 2005 advances by
December 31, 2005. As of December 31, 2007 and 2006,
unpaid advances were approximately $648,000 and $35,000,
respectively. As of September 15, 2008, Mr. Collard
has no outstanding salary advances from Cornerstone, and
Cornerstone has adopted a policy prohibiting any such advances
in the future.
In May 2005, Cornerstone licensed certain product rights to
Auriga, which is owned in part by Mr. Collard,
Ms. Baldwin and Mr. Lutz. Mr. Collard,
Ms. Baldwin, and Mr. Lutz own approximately 3.0%,
0.1%, and 0.2%, respectively, of the outstanding common stock of
Auriga based on 79,536,557 total shares outstanding on
May 12, 2008, as disclosed in Aurigas Quarterly
Report on
Form 10-Q
for the quarterly period ended March 31, 2008. The
effective date of the agreement with Auriga is August 1,
2005. Cornerstone received a royalty ranging from 8% to 30% of
net sales, depending on the level of net sales.
Cornerstones royalty is not to exceed $1.7 million on
an annual basis. Auriga assumed responsibility for royalty
payments to the previous owner of the product rights as of the
effective date. In 2006, the royalty agreement with Auriga was
amended to reduce the royalty rates from 30% to 5% of net sales
in a specific calendar quarter. The amendment also provided for
Auriga to issue Cornerstone 200,000 shares of its common
stock. The fair value of the stock, determined as the trading
price on date of grant discounted 15% for lack of marketability
due to a one-year lock up period, was approximately $332,000.
Cornerstone included this amount in royalty agreement revenues.
299
Review,
Approval or Ratification of Transactions with Related
Persons
The policies and procedures of the combined company for the
review, approval, or ratification of related-person transactions
are expected to be determined at the first meeting of the board
of directors following the consummation of the merger.
Director
Independence
Under applicable NASDAQ rules, a director will only qualify as
an independent director if, in the opinion of
Critical Therapeutics board of directors, that person does
not have a relationship which would interfere with the exercise
of independent judgment in carrying out the responsibilities of
a director.
In connection with the consummation of the merger, the incumbent
directors of the Critical Therapeutics board of directors
will fix the size of the board at five directors, tender their
resignations effective as of the effective time of the merger
and simultaneously appoint Messrs. Collard, McEwan,
Codeanne, Enright and Heffernan to fill the vacancies created by
such resignations. Prior to appointing Messrs. Codeanne,
Enright and Heffernan to the Critical Therapeutics board of
directors, the incumbent directors will determine whether
Messrs. Codeanne, Enright and Heffernan are independent as
defined under NASDAQ rules. Additionally, the incumbent
directors of Critical Therapeutics will determine whether those
individuals meet the additional independence requirements of
Rule 10A-3
under the Securities Exchange Act of 1934. Finally, the
incumbent directors of Critical Therapeutics will determine
whether all of the members of each of the board of
directors three standing committees will be independent as
defined under NASDAQ rules. If Critical Therapeutics board
of directors determines that any of Messrs. Codeanne,
Enright and Heffernan is not independent as defined under NASDAQ
rules or does not meet the additional independence requirements
of
Rule 10A-3
under the Securities Act, Cornerstone would withdraw the
nomination of such individual and instead would nominate another
individual that is independent under those rules.
Executive
Compensation and Other Information
The following discussion and tables set forth information with
regard to compensation for services rendered in all capacities
to Cornerstone and its subsidiaries, and to Critical
Therapeutics, during the fiscal year ended December 31,
2007, by individuals who are expected to serve as executive
officers of the combined company following the consummation of
the merger.
Cornerstones
Compensation Discussion and Analysis
Following the consummation of the merger, Cornerstone
anticipates that each of Mr. Collard, Ms. Baldwin,
Dr. Dickson, Mr. Esgro, Mr. Lutz, Mr. Price and
Mr. Townsend will serve as an executive officer of the combined
company. Each of these individuals, except for Mr. Townsend,
currently serves as an executive officer of Cornerstone.
Compensation decisions with respect to Cornerstones
executive officers have historically been based on the objective
of attracting and retaining individuals who can help Cornerstone
meet and exceed its financial and operational goals. Cornerstone
generally considers the growth of the company, individual
performance and market trends in setting individual compensation
levels for its executive officers. Cornerstone provides both
cash and equity-based compensation, with the goal of the latter
being to align the interests of Cornerstones executive
officers with the interest of Cornerstones stockholders
and incentivize the executive officers to achieve long-term
growth for Cornerstone. Cornerstone currently awards
equity-based compensation to its executive officers on an
entirely discretionary basis.
Determination
of Compensation
For fiscal year 2007, Cornerstone did not have a compensation
committee and all compensation decisions regarding
Cornerstones executive officers were made by
Cornerstones board of directors. The board of directors
received compensation recommendations for the executive officers
from the Chief Executive Officer. These recommendations were
based on the executive officers achievement of individual
performance goals and the results of the individual performance
evaluation process. Cornerstones board of directors
reviewed these recommendations, proposed adjustments and,
subject to any reviews it deemed appropriate, approved the
300
compensation packages for its executive officers. The board of
directors also considered certain subjective factors in
determining an executives compensation, including, but not
limited to, the executives contribution to achievement of
Cornerstones financial goals, the executive officers
management ability and whether the executive officers
total compensation was competitive in the market given the
executive officers responsibilities.
Components
of Compensation for Fiscal Year 2007
For fiscal year 2007, the compensation provided to
Cornerstones executive officers who will become executive
officers of the combined company following the consummation of
the merger consisted of base salary, annual bonus and
equity-based compensation, each of which is described in more
detail below.
Base
Salary
The base salary payable to each of Cornerstones executive
officers is intended to provide a fixed component of
compensation reflecting the executive officers skill set,
experience, role and responsibilities. Additionally,
Cornerstones board of directors intended for the salary
paid to each of the executive officers to be competitive within
the Raleigh/Durham, North Carolina geographic area where
Cornerstone is headquartered, within the pharmaceutical industry
as a whole and with companies with a comparable volume of
general sales. Minimum base salaries are set forth in each of
the executive officers employment agreements, the terms of
which are set forth in the section Narrative Disclosure to
Summary Compensation Table and Grants of Plan-Based Awards
Table beginning on page 312 of this proxy
statement/prospectus. The determination of Cornerstones
board of directors as to whether an increase in base salary is
merited for any executive officer during any particular year
depends on the individuals performance during the prior
year, Cornerstones performance during the prior year and
on competitive market practices.
For fiscal 2007, base salaries generally accounted for 65% of
each executive officers total compensation. The following
table sets forth annual base salary rates in effect at the end
of fiscal 2006 and fiscal 2007 for each of the executive
officers, as well as percentage increases from 2006 to 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent
|
|
Name
|
|
Fiscal 2006
|
|
|
Fiscal 2007
|
|
|
Increase
|
|
|
Craig A. Collard
|
|
$
|
295,697
|
|
|
$
|
365,000
|
|
|
|
23
|
%
|
Chenyqua Baldwin
|
|
$
|
166,278
|
|
|
$
|
215,000
|
|
|
|
29
|
%
|
Brian Dickson, M.D.
|
|
$
|
239,787
|
|
|
$
|
260,000
|
|
|
|
8
|
%
|
George Esgro
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Steven M. Lutz
|
|
$
|
204,000
|
|
|
$
|
204,000
|
(1)
|
|
|
|
|
David Price
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
|
(1) |
|
On March 16, 2007, Cornerstones board of directors
approved a 2007 salary of $230,000 for Mr. Lutz, or an
increase of approximately 12.7% from his 2006 salary. However,
because Cornerstones board of directors placed an
administrative condition on Mr. Lutzs receipt of the
$230,000 salary amount, and that condition was not met,
Mr. Lutz received a base salary in 2007 equal to his 2006
annual salary, or $204,000. |
Mr. Collards base salary increase from fiscal 2006 to
fiscal 2007 was 23%. In determining this increase,
Cornerstones board of directors considered the percentage
salary increases received by all other Cornerstone employees
during the period. Mr. Collard was then provided with an
increase equivalent to the average percentage salary increase
received by all other employees.
Ms. Baldwins base salary increase from fiscal 2006 to
fiscal 2007 was 29%. In determining this increase,
Cornerstones board of directors considered
Ms. Baldwins salary in relation to her experience,
and her achievement of her 2006 performance goals which
included: achievement of Cornerstones gross revenue target
for 2006 of $26 million, maintaining the Finance
Departments 2006 budget within the targeted level of
$1.1 million, maintaining Cornerstones 2006
operational spending budget within the targeted level of
$11.9 million, effectively managing Cornerstones
relationship with its independent auditors, effectively
301
documenting Cornerstones policies and procedures,
effectively assisting Cornerstones legal team and
effectively completing the financial planning, analysis and
modeling related to investor presentations.
Dr. Dicksons base salary increase from fiscal 2006 to
fiscal 2007 was 8%. Cornerstones board of directors
considered Dr. Dicksons salary compared to similar
positions at peer companies, and his achievement of his 2006
performance goals, which included: preparing and submitting FDA
applications relating to Cornerstones products, directing
the negotiations to acquire additional products, effectively
assisting the legal team, effectively working with the
manufacturers of Cornerstones products, filing on time all
required reports related to Cornerstones products with the
FDA, and effectively developing Cornerstones product
portfolio.
Annual
Bonuses
Annual bonuses are intended to link Cornerstones strategic
and corporate operating plans with individual performance, and
to provide executive officers with incentives to achieve greater
corporate performance by focusing on the attainment of specific
goals. The target bonus awards for executive officers is based
on a percentage of the annual base salary approved by
Cornerstones board of directors, and is set at 50% of base
salary for the Chief Executive Officer, and 35% of base salary
for all other executive officers.
In determining the amount of the annual bonus for each executive
officer, Cornerstones board of directors considered the
executive officers achievement of individual goals
established on a quarterly basis. At the beginning of each
quarter, the Chief Executive Officer establishes individual
quarterly goals for each executive officer, and these goals are
provided to the executive officer in writing. These goals are
tailored to the specific duties and responsibilities of each
executive officer and are intended to focus the executive
officers on achieving short-term objectives within their
specific area of responsibility. Typically, the Chief Executive
Officer meets with each executive officer on a monthly basis to
track the progress of the individuals quarterly goals.
Cornerstones board of directors considered each executive
officers achievement of, or failure to achieve, individual
quarterly goals in determining whether that executive officer
received the full amount of his or her target bonus award, a
lesser amount of annual bonus, or no annual bonus. In 2007, all
of Cornerstones executive officers received the full
amount of their target bonus awards.
Bonuses are paid to executive officers on an annual basis
following completion of Cornerstones audit. In order to be
eligible to receive an annual bonus, the executive officer must
be an employee of Cornerstone at the time of the completion of
the audit. With the exception of Mr. Collard, executive
officers whose employment is terminated prior to the completion
of the audit will not receive any bonus payment for the prior
fiscal year, regardless of whether such executive officer was
employed by Cornerstone at the end of the fiscal year. Under his
Executive Retention Agreement, described in the section
Narrative Disclosure to Summary Compensation Table and
Grants of Plan-Based Awards Table Employment and
Related Agreements beginning on page 312 of this
proxy statement/prospectus, Mr. Collard would be entitled
to receive certain annual bonus payments for the fiscal year
under certain circumstances in the event his employment is
terminated in connection with a change in control prior to the
completion of Cornerstones audit.
The following chart shows bonuses received in fiscal 2006 and
fiscal 2007 for each of the executive officers, as well as
percentage increases from 2006 to 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent
|
|
Name
|
|
Fiscal 2006
|
|
|
Fiscal 2007
|
|
|
Increase
|
|
|
Craig A. Collard
|
|
$
|
147,849
|
|
|
$
|
182,500
|
|
|
|
23.4
|
%
|
Chenyqua Baldwin
|
|
$
|
58,197
|
|
|
$
|
75,250
|
|
|
|
29.3
|
%
|
Brian Dickson, M.D.
|
|
$
|
83,925
|
|
|
$
|
91,000
|
|
|
|
8.4
|
%
|
George Esgro
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Steven M. Lutz
|
|
$
|
71,400
|
|
|
$
|
87,500
|
|
|
|
22.5
|
%
|
David Price
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
302
Equity
Compensation
Cornerstones equity compensation awards are designed to
align the interests of Cornerstones executive officers
with the interests of Cornerstones stockholders by
providing the executive officers with equity ownership
opportunities and performance-based incentives. In fiscal 2007,
all equity awards by Cornerstone were in the form of stock
options.
While Cornerstone encourages its executive officers to own
substantial equity of the company, equity grants have
historically been made to the executive officer at the time the
officer joins Cornerstone, rather than as a component of annual
compensation. Any additional equity grants to executive officers
are made on an entirely discretionary basis by the board of
directors and are based on subjective factors including, but not
limited to, the individuals contribution to Cornerstone
and the individuals total holdings of the equity of
Cornerstone.
All of the equity compensation awards granted in fiscal 2007
were granted under Cornerstones 2005 Stock Incentive Plan.
The stock options awarded in fiscal 2007 will vest in 25%
increments on the anniversary of the date of the grant in 2008,
2009, 2010 and 2011.
Perquisites
and Other Benefits
Cornerstone has provided perquisites to its executive officers
as a means of providing additional compensation to the executive
officers, through the availability of benefits that are
convenient for the executives to use when faced with the demands
of their positions. These perquisites included the use of
company cars or automobile allowances, and in the case of
Cornerstones Chief Executive Officer, a country club
membership.
In addition, Cornerstones executive officers, like other
employees, are entitled to participate in Cornerstones
employee benefit plans including medical insurance, dental
insurance, vision insurance, life insurance, long-term
disability insurance and a 401(k) savings plan.
Cornerstones executive officers, unlike other employees,
are not required to make any payments or other contributions in
order to participate in the medical insurance, dental insurance
or vision insurance plans.
Severance
Benefits
Cornerstones executive officers are entitled to receive
severance benefits upon qualifying terminations of employment,
pursuant to provisions in each executives employment
agreement or executive retention agreement, and the terms of the
2005 Stock Incentive Plan. These severance arrangements are
primarily intended to retain the executive officers, as the
executive officers will forego the right to receive a
significant payment if they voluntarily terminate their
employment without good reason. For a more complete description
of these severance arrangements, please see the section
Narrative Disclosure to Summary Compensation Table and
Grants of Plan-Based Awards Table beginning on
page 312 of this proxy statement/prospectus, and the
section Potential Payments upon Termination or Change in
Control with Respect to Cornerstones Executive
Officers beginning on page 323 of this proxy
statement/prospectus.
Critical
Therapeutics Compensation Discussion and
Analysis
Mr. Townsend, the Senior Vice President of Legal Affairs,
General Counsel and Secretary of Critical Therapeutics, is
expected to serve as General Counsel, Executive Vice President
of Legal Affairs and Secretary for the combined company. This
compensation discussion and analysis relates to
Mr. Townsends service with Critical Therapeutics and
describes the material elements of compensation awarded to,
earned by, or paid to Mr. Townsend in connection with that
service identified in the Summary Compensation Table below. This
compensation discussion and analysis focuses on the information
contained in the following tables and related footnotes and
narrative for primarily the last completed fiscal year, but also
describes compensation actions taken before or after the last
completed fiscal year to the extent it enhances the
understanding of the executive compensation disclosure related
to Mr. Townsend.
The Compensation Committee of Critical Therapeutics board
of directors oversees its executive compensation program. In
this role, the Compensation Committee of Critical Therapeutics
annually reviews and approves, or recommends for approval, all
compensation decisions relating to its executive officers.
303
Objectives
and Philosophy of Critical Therapeutics Executive
Compensation Program
The objectives of Critical Therapeutics executive
compensation program are to align the interests of management
with the interests of stockholders through a system that relates
compensation to the achievement of business objectives and
individual performance. Critical Therapeutics executive
compensation philosophy is based on the following principles:
Competitive
and Fair Compensation
Critical Therapeutics is committed to providing an executive
compensation program that helps it to attract, motivate and
retain highly qualified and industrious executives. Its policy
is to provide total compensation that is competitive for
comparable work and comparable corporate performance. In
addition to providing competitive compensation packages,
Critical Therapeutics also seeks to achieve a balance of the
compensation paid to a particular individual and the
compensation paid to its other executives and employees.
Sustained
Performance
Executive officers are rewarded based upon an assessment of
corporate, business group and individual performance. Corporate
performance and business group performance are evaluated by
reviewing the extent to which strategic and business plan goals
are met, including such factors as achievement of operating
budgets, establishment of strategic development alliances with
third parties and timely accomplishment of strategic objectives.
Individual performance is evaluated by reviewing attainment of
specified individual objectives and the degree to which teamwork
and Critical Therapeutics other values are fostered.
Retention
Critical Therapeutics has placed significant emphasis on
retention of key executives in structuring its executive
compensation programs for 2007 and 2008. Critical
Therapeutics goal in doing so is to provide such
executives with an incentive to remain employed and engaged
notwithstanding the usual uncertainties attendant to the
examination of various strategic alternatives for its business.
Comparative
Compensation Review and Benchmarking
Critical Therapeutics does not believe that it is appropriate to
establish compensation levels primarily based on benchmarking.
It believes, however, that information regarding pay practices
at other companies is useful in two respects. First, Critical
Therapeutics recognizes that its compensation practices must be
competitive in the marketplace. Second, this marketplace
information is one of the many factors that are considered in
assessing the reasonableness of compensation. Accordingly,
Critical Therapeutics regularly compares its compensation
packages with those of other companies in the biotechnology and
pharmaceutical industry, through reviews of survey data and
information gleaned from filings of publicly traded companies
and through information compiled and analyzed by its
compensation consultants. However, while such information may be
a useful guide for comparative purposes, Critical Therapeutics
believes that a successful compensation program also requires
the application of judgment and subjective determinations of
individual performance. Critical Therapeutics review of
this information and these factors forms the basis of its
compensation recommendations.
In making compensation decisions, the Compensation Committee of
Critical Therapeutics compares Critical Therapeutics
executive compensation against that paid by a peer group of
publicly traded companies in the biotechnology and
pharmaceutical industry compiled by Nancy Arnosti, a
compensation consultant specializing in the compensation of
senior executives retained by the Compensation Committee in
2006. This peer group consists of the following companies, which
the Compensation Committee believed were generally comparable to
the company at the time and against which the committee believed
it competed for executive talent: Abgenix, Inc.; Anesiva, Inc.;
Anika Therapeutics, Inc.; Array BioPharma Inc.; Cell
Therapeutics, Inc.; Cepheid; Corixa Corporation; Cryolife, Inc.;
CV Therapeutics, Inc.; Dyax Corp.; Embrex, Inc.; Enzo Biochem,
Inc.; Eyetech Pharmaceuticals, Inc.; Icoria, Inc.; ImmunoGen,
Inc.; Indevus Pharmaceuticals, Inc.; InKine Pharmaceutical
Company, Inc.; Kosan Biosciences Incorporated; Lexicon
Pharmaceuticals, Inc.; LifeCell
304
Corporation; Lifecore Biomedical, Inc.; Maxygen, Inc.; Myriad
Genetics, Inc.; NitroMed, Inc.; North American Scientific, Inc.;
OraSure Technologies, Inc.; Orchid Cellmark Inc.; Sequenom,
Inc.; Tanox, Inc.; Third Wave Technologies, Inc.; Transgenomic,
Inc.; Verenium Corporation; ViroPharma Incorporated; Zila, Inc.;
and ZymoGenetics, Inc.
The Compensation Committees charter grants it the
authority to retain outside advisors, including compensation
consultants, and approve their compensation. Critical
Therapeutics is obligated to pay the Compensation
Committees advisors and consultants. These advisors and
consultants report directly to the Compensation Committee.
Pursuant to its authority, the Compensation Committee first
engaged Ms. Arnosti in late 2004 to assist the committee in
its review of Critical Therapeutics executive employment
arrangements and in formulating recommendations regarding such
arrangements for 2005. The Compensation Committee instructed
Ms. Arnosti to conduct a review of survey data and
information gleaned from filings of publicly traded companies
regarding executive officer base salary, target bonus and equity
ownership information. Ms. Arnosti produced a report for
Critical Therapeutics regarding executive employment
arrangements at biotechnology and pharmaceutical companies
comparable to Critical Therapeutics, and the Compensation
Committee discussed the results of this report with her in
detail in arriving at its recommendations regarding the
employment agreements entered into with its senior executives in
2004 and in setting the initial base salaries and bonus
opportunities reflected in such agreements. In addition,
Ms. Arnosti produced updated analyses of executive
compensation arrangements for Critical Therapeutics in October
2005, December 2006 and October 2007, which the Compensation
Committee considered in arriving at recommendations for the
market adjustment and merit increases in executive base salaries
and bonus opportunities for 2006, 2007 and 2008 that are
described in the section Narrative Disclosure to Summary
Compensation Table and Grants of Plan-Based Awards
Table Employment and Related Agreements
beginning on page 312 of this proxy
statement/prospectus. In December 2006, the Compensation
Committee reviewed a report from another compensation
consultant, Pearl Meyer & Partners, which had been
retained by the Compensation Committee to assist in the
development of an executive and key employee success bonus and
retention program for 2007. However, the Compensation Committee
determined at that time not to establish a retention program for
Critical Therapeutics executives and, therefore, did not
utilize the data from the Pearl Meyer & Partners
report.
Elements
of Executive Compensation
Compensation for Critical Therapeutics executives
generally consists of the following elements:
|
|
|
|
|
salary;
|
|
|
|
bonus;
|
|
|
|
stock-based awards;
|
|
|
|
health, dental, life and disability insurance and other
traditional employee benefits; and
|
|
|
|
severance and
change-in-control
arrangements.
|
Critical Therapeutics has not had any formal or informal policy
or target for allocating compensation between long-term and
short-term compensation, between cash and non-cash compensation
or among the different forms of non-cash compensation. Instead,
the Compensation Committee of Critical Therapeutics, after
reviewing information provided by its compensation consultants,
determines subjectively what it believes to be the appropriate
level and mix of the various compensation components.
Ultimately, the Compensation Committees objective in
allocating between long-term and currently paid compensation is
to ensure adequate base compensation to attract and retain
personnel, while providing incentives to maximize long-term
value for Critical Therapeutics and its stockholders. Therefore,
Critical Therapeutics provides cash compensation in the form of
base salary to meet competitive salary norms and reward good
performance on an annual basis and in the form of bonus
compensation to reward superior performance against specific
annual goals, as well as to create incentives to remain employed
with Critical Therapeutics through specified periods. Critical
Therapeutics provides non-cash compensation to reward superior
performance against specific objectives and long-term strategic
goals, as well as to create incentives to remain employed with
the company.
305
Salary
Salary for Critical Therapeutics executives is generally
set by reviewing compensation for comparable positions in the
market, as described above, and the historical compensation
levels of its executives. Salaries are then adjusted from time
to time, but at least once annually, based upon market changes,
actual corporate and individual performance and promotions or
changes in responsibilities.
On November 5, 2007, based on the recommendation of the
Compensation Committee, Critical Therapeutics independent
directors approved a market adjustment and merit increase in the
annual base salary for Mr. Townsend effective as of
January 1, 2008. Critical Therapeutics independent
directors approved a 2008 annual base salary of $275,000 for
Mr. Townsend.
Bonuses
Bonuses, as well as annual increases in salaries, generally are
based on actual corporate and individual performance compared to
targeted performance criteria and various subjective performance
criteria. The Compensation Committee of Critical Therapeutics
works with the companys President and Chief Executive
Officer to develop corporate and individual goals that they
believe can be reasonably achieved with an appropriate level of
effort over the course of the year. Targeted performance
criteria vary for each executive based on his or her business
group or area of responsibility, and may include:
|
|
|
|
|
achievement of the operating budget for Critical Therapeutics as
a whole and of the business group of Critical Therapeutics for
which the executive is responsible;
|
|
|
|
continued innovation in development and commercialization of
Critical Therapeutics technology;
|
|
|
|
timely development of new product candidates or processes;
|
|
|
|
development and implementation of successful marketing and
commercialization strategies; and
|
|
|
|
implementation of financing strategies and establishment of
strategic development alliances with third parties.
|
In March 2007, the Compensation Committee established the
following company goals to be considered in determining actual
bonus amounts for executive officers in respect of the 2007
fiscal year:
|
|
|
|
|
enhance the commercial value of ZYFLO CR by signing a
co-promotion arrangement for ZYFLO CR, launching ZYFLO CR
following FDA approval, initiating a Phase IIIb clinical trial
of ZYFLO CR, increasing ZYFLO prescriptions and achieving
specified business development goals;
|
|
|
|
progress the research and development pipeline by initiating a
Phase II clinical trial of zileuton injection, completing
specified preclinical work for the alpha-7 receptor program,
establishing a co-development collaboration arrangement for the
alpha-7 receptor program and supporting MedImmune in selecting a
lead candidate for the HMGB1 program;
|
|
|
|
establish a strong financial position by managing corporate cash
spending and ensuring adequate funding and communicate
effectively with investors; and
|
|
|
|
create an attractive organization by establishing employee
programs, recruiting key employees and developing a long-term
facility strategy.
|
In establishing these goals, the Compensation Committee
considered their importance to the overall success of the
company, as well as the relative difficulty of achieving them.
The Compensation Committee believed that these goals were clear
and would require significant efforts on the part of Critical
Therapeutics executive team, but were, ultimately,
achievable.
Subjective performance criteria include an executives
ability to motivate others, develop the skills necessary to grow
as Critical Therapeutics matures as a company, recognize and
pursue new business opportunities and initiate programs to
enhance Critical Therapeutics growth and success. The
Compensation Committee does not rely on a formula that assigns a
pre-determined value to each of the criteria, but instead
evaluates an
306
executive officers contribution in light of all criteria.
Although generally none of Critical Therapeutics executive
officers is guaranteed an annual cash bonus, the company paid
retention bonuses in lieu of cash bonuses based on performance
goals for 2006 and established minimum bonuses for 2007, as
described below.
In addition to targeted performance bonuses, Critical
Therapeutics employs bonuses designed to retain executives under
certain circumstances. These retention bonuses were used by
Critical Therapeutics to retain executives in an uncertain
business environment. Such bonuses have typically been payable
so long as the executive remains employed as of a particular
date or event. For example, in November 2006, the Compensation
Committee determined that, in lieu of a cash bonus for 2006
based on performance goals, its executive officers and other
employees, other than sales specialists and sales managers,
designated by Critical Therapeutics President and Chief
Executive Officer would be entitled to receive a bonus payment
equal to 50% of their potential or target bonus for 2006 if they
remained employed by Critical Therapeutics as of
January 15, 2007, and an additional 50% of their potential
or target bonus for 2006 if they remain employed by Critical
Therapeutics on the date it received an action letter from the
FDA on its NDA for ZYFLO CR. Critical Therapeutics paid cash
bonuses to Mr. Townsend in late January 2007 of $34,500 and
in June 2007 of $34,500. Pursuant to an amended and restated
employment agreement that Critical Therapeutics entered into
with Mr. Townsend in November 2007, he was entitled to a
minimum cash bonus of $73,500 for 2007 if he remained employed
with Critical Therapeutics through December 31, 2007.
Critical Therapeutics paid this bonus in January 2008.
Accordingly, the Compensation Committee did not formally
establish individual performance goals for Mr. Townsend for 2007.
On November 5, 2007, based on the recommendation of the
Compensation Committee, Critical Therapeutics independent
directors established the target annual cash bonus for
Mr. Townsend for 2008. The independent directors approved a
target annual cash bonus for 2008, as a percentage of 2008
annual base salary, of 30% for Mr. Townsend. The
Compensation Committee may make actual cash bonus awards that
may be greater or less than the target annual cash bonus based
on overall corporate performance and individual performance.
Mr. Townsend is not guaranteed any annual cash bonus.
Stock-Based
Awards
Compensation for executive officers also includes the long-term
incentives afforded by stock options and restricted stock
awards. Critical Therapeutics stock option and restricted
stock award program is designed to align the long-term interests
of its employees and its stockholders and assist in the
retention of executives. The size of stock-based awards is
generally intended to reflect the executives position with
Critical Therapeutics and his or her contributions to the
company, including his or her success in achieving the
individual performance criteria described above and his or her
contributions to Critical Therapeutics corporate goals.
Critical Therapeutics generally makes stock-based awards on an
annual basis in connection with its annual reviews of executive
performance and compensation, but will also make such awards in
connection with appropriate events, such as the promotion of the
executive, or as part of a retention program. Critical
Therapeutics generally grants annual stock-based awards at the
last regularly scheduled meeting of its board of directors and
the Compensation Committee for each calendar year. The
Compensation Committee may consider the value of stock-based
awards or other long-term compensation arrangements previously
granted or entered into with the executive in making grants of
stock-based awards, but a significant amount of value
represented by previous awards will not necessarily cause the
committee to forego making, or reduce the size of, a future
award. Critical Therapeutics generally grants stock options with
annual vesting schedules over a four-year period to encourage
key employees to continue their employment with the company.
Because of the direct relationship between the value of an
option and the market price of Critical Therapeutics
common stock, the Compensation Committee has always believed
that granting stock options is an effective method of motivating
the executive officers to manage the company in a manner that is
consistent with the interests of the company and its
stockholders. However, because of the evolution of regulatory,
tax and accounting treatment of equity incentive programs, and
because it is important to the company to retain Critical
Therapeutics executive officers and key employees, the
Compensation Committee realizes that it is important that the
company utilize other forms of equity awards as and when it may
deem necessary. In 2006, Critical Therapeutics granted
restricted stock awards to all of its employees, including its
executives in
307
December 2006, as it believed that this was a more efficient way
to reward them for and motivate them toward superior
performance. These restricted stock awards vest as to 50% of the
shares subject to the awards on each of the first and second
anniversaries of the grant date. In November 2007, Critical
Therapeutics made restricted stock awards of 25,000 shares
to Mr. Townsend in connection with its annual performance
review of its executives. This restricted stock award vests as
to 50% of the shares subject to the award on each of the
six-month and
24-month
anniversaries of the grant date. In February 2008, Critical
Therapeutics made a restricted stock award of 35,000 shares
to Mr. Townsend in connection with rewarding and retaining
this executive. This restricted stock award vests as to 50% of
the shares subject to the award on each of the six-month and
24-month
anniversaries of the grant date.
Insurance
and Other Employee Benefits
Critical Therapeutics maintains broad-based benefits and
perquisites that are provided to all employees, including health
insurance, life and disability insurance, dental insurance and a
401(k) plan. In November 2005, Critical Therapeutics board
of directors, based on the recommendation of the Compensation
Committee, approved, effective as of January 1, 2006, a
matching contribution for each 401(k) participant of 50% of the
participants elective deferrals for a plan year up to 6%
of the participants salary. Critical Therapeutics
matching contribution up to $3,000 per year is fully and
immediately vested. In particular circumstances, Critical
Therapeutics also utilizes cash signing bonuses and pay
relocation expenses when executives join the company. Such cash
signing bonuses and relocation expenses are typically repayable
in full to Critical Therapeutics if the executive voluntarily
terminates employment with the company, or Critical Therapeutics
terminates the executive for cause, prior to the first
anniversary of the date of hire. Whether a signing bonus and
relocation expenses are paid and the amount thereof is
determined on a
case-by-case
basis under the specific hiring circumstances. For example,
Critical Therapeutics will consider paying signing bonuses to
compensate for amounts forfeited by an executive upon
terminating prior employment or to create additional incentive
for an executive to join the company in a position for which
there is high market demand. Critical Therapeutics did not pay
any such signing bonuses or relocation expenses in 2007.
Severance
and
Change-in-Control
Arrangements
Compensation for executive officers also includes severance and
change-in-control
arrangements, which are generally reflected in the employment
agreements for such officers. These arrangements, like other
elements of executive compensation, are structured with regard
to practices at comparable companies for similarly-situated
officers and in a manner Critical Therapeutics believes is
likely to attract and retain high quality executive talent.
Changes to existing severance arrangements are also sometimes
negotiated with departing executives in exchange for transition
services
and/or
general releases. The severance and
change-in-control
arrangement currently in effect with respect to
Mr. Townsend is described in greater detail in the section
Narrative Disclosure to Summary Compensation Table and
Grants of Plan-Based Awards Table Employment and
Related Agreements with Mr. Townsend beginning on
page 314 of this proxy statement/prospectus. Because
these severance and
change-in-control
arrangements are designed primarily for retention purposes,
amounts payable in connection with such arrangements do not
generally affect other elements of compensation payable to
executive officers.
Change-in-control
arrangements in place for Mr. Townsend in 2007 were
structured with respect to cash compensation as double
trigger benefits. In other words, a change in control in
2007 would not have triggered the payment of cash benefits to
Mr. Townsend. Rather, these benefits would have been
payable only if Mr. Townsends employment was
terminated in specific circumstances during a specified period
in connection with a change in control. In addition, a change in
control would have triggered only partial accelerated vesting of
Mr. Townsends stock options and restricted stock,
whereas full accelerated vesting of these awards would have
occurred only if Mr. Townsends employment was
terminated in specific circumstances during a specified period
in connection with a change in control. The Compensation
Committee believed at that time that a double
trigger benefit would maximize stockholder value because,
in its view, the double trigger would prevent an unintended
windfall to executives in the event of a friendly change in
control, while still providing the executives appropriate
incentives to cooperate in negotiating any change in
308
control in which they believe they may lose their jobs. After
Critical Therapeutics entered into the merger agreement with
Cornerstone, in July 2008, it established a change in control
bonus program for its executives, including Mr. Townsend,
to ensure that the company would retain the services of its
executives through the closing of the transaction. This change
in control bonus program has a single trigger
mechanism that provides for the payment of a cash bonus to the
executives upon the closing of the merger.
Other
Corporate Policies Relating to Executive Compensation
Role
of Executive Officers in Determining or Recommending Executive
Compensation
The management of Critical Therapeutics plays a significant role
in the process of setting executive compensation. The most
significant aspects of managements role are:
|
|
|
|
|
evaluating employee performance;
|
|
|
|
establishing business performance targets and
objectives; and
|
|
|
|
recommending salary levels and stock-based awards.
|
Critical Therapeutics President and Chief Executive
Officer works with the chair of the Compensation Committee in
establishing the agenda for committee meetings. Management also
prepares meeting information for each Compensation Committee
meeting. Critical Therapeutics President and Chief
Executive Officer also participates in Compensation Committee
meetings at the Committees request to provide:
|
|
|
|
|
background information regarding Critical Therapeutics
companys strategic objectives and progress toward the
attainment of those objectives;
|
|
|
|
his evaluation of the performance of the senior executive
officers; and
|
|
|
|
compensation recommendations as to senior executive officers,
other than himself.
|
Ultimately, however, all compensation decisions are made, or
recommended to Critical Therapeutics board of directors,
by the Compensation Committee, which makes such decisions and
recommendations after considering managements
recommendations in light of those made by its compensation
consultant and engaging in deliberations in executive session
without the presence of any members of management.
Impact
of Tax Treatment on Compensation Decisions
Section 162(m) of the Internal Revenue Code of 1986, as
amended, generally disallows a tax deduction for compensation in
excess of $1.0 million paid to Critical Therapeutics
Chief Executive Officer and its other officers whose
compensation is required to be disclosed to its stockholders
pursuant to the Exchange Act by reason of being among its four
other most highly compensated officers. Qualifying
performance-based compensation is not subject to the deduction
limitation if specified requirements are met. Critical
Therapeutics periodically reviews the potential consequences of
Section 162(m) and it generally intends to structure the
performance-based portion of its executive compensation, where
feasible, to comply with exemptions in Section 162(m) so
that the compensation remains tax deductible to it. However, the
Compensation Committee may, in its judgment, authorize
compensation payments that do not comply with the exemptions in
Section 162(m) when it believes that such payments are
appropriate to attract and retain executive talent.
Security
Ownership Requirements or Guidelines
While Critical Therapeutics believes it is important for its
executives to have an equity stake in the company in order to
help align their interests with those of its stockholders, it
does not currently have any equity ownership guidelines for its
executive officers.
309
Summary
Compensation Table
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
|
|
|
Option
|
|
|
Incentive Plan
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
Salary
|
|
|
Bonus
|
|
|
Awards
|
|
|
Awards
|
|
|
Compensation
|
|
|
Compensation
|
|
|
Total
|
|
Name and Principal Position
|
|
Year
|
|
|
($)
|
|
|
($)(1)
|
|
|
($)(2)
|
|
|
($)(3)
|
|
|
($) (4)
|
|
|
($)
|
|
|
($)
|
|
|
Craig A. Collard
|
|
|
2007
|
|
|
|
365,000
|
|
|
|
|
|
|
|
|
|
|
|
53,968
|
|
|
|
182,500
|
|
|
|
59,469
|
(5)
|
|
|
660,937
|
|
President and Chief Executive Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chenyqua Baldwin
|
|
|
2007
|
|
|
|
215,000
|
|
|
|
|
|
|
|
|
|
|
|
41,262
|
|
|
|
75,250
|
|
|
|
26,411
|
(6)
|
|
|
357,923
|
|
Vice President, Finance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brian Dickson, M.D.
|
|
|
2007
|
|
|
|
260,000
|
|
|
|
|
|
|
|
|
|
|
|
52,261
|
|
|
|
91,000
|
|
|
|
25,238
|
(7)
|
|
|
428,499
|
|
Chief Medical Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
George Esgro(8)
|
|
|
2007
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Vice President, Sales and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven M. Lutz
|
|
|
2007
|
|
|
|
204,000
|
|
|
|
|
|
|
|
|
|
|
|
42,834
|
|
|
|
87,500
|
|
|
|
28,064
|
(9)
|
|
|
362,398
|
|
Executive Vice President, Manufacturing and Trade
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Price(10)
|
|
|
2007
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
|
|
N/A
|
|
Executive Vice President, Finance, and Chief Financial Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott B. Townsend, Esq.(11)
|
|
|
2007
|
|
|
|
245,000
|
(12)
|
|
|
73,500
|
|
|
|
28,367
|
|
|
|
185,468
|
|
|
|
|
|
|
|
1,648
|
(13)
|
|
|
533,983
|
|
General Counsel,
|
|
|
2006
|
|
|
|
225,000
|
(12)
|
|
|
69,000
|
|
|
|
105
|
|
|
|
146,499
|
|
|
|
|
|
|
|
3,000
|
(14)
|
|
|
443,604
|
|
Executive Vice President of Legal Affairs and Secretary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The amounts in the Bonus column represent retention
bonuses paid to Mr. Townsend as a Critical Therapeutics
executive officer in lieu of cash bonuses for 2006 and 2007
based on performance goals. For more information regarding these
retention bonuses, see Critical Therapeutics
Compensation Discussion and Analysis Bonuses. |
|
(2) |
|
The amounts in the Stock Awards column reflect the
dollar amounts recognized as compensation expense by Critical
Therapeutics for financial statement reporting purposes for
restricted stock awards to Mr. Townsend by Critical
Therapeutics for the fiscal year ended December 31, 2007 in
accordance with SFAS 123(R), disregarding the estimate of
forfeitures related to service-based vesting conditions. The
assumptions Critical Therapeutics used to calculate these
amounts are discussed in Note 2 to Critical
Therapeutics consolidated financial statements beginning
on page F-8 of this proxy statement/prospectus. |
|
(3) |
|
The amounts in this column reflect the dollar amounts recognized
as compensation expense for financial statement reporting
purposes for stock options for the fiscal year ended December
31, 2007 in accordance with SFAS 123(R). The assumptions
Cornerstone used to calculate these amounts are discussed in
Note 7 to Cornerstones consolidated financial statements
beginning on page
F-74 of this
proxy
statement/prospectus.
For Mr. Townsend, this amount disregards the estimate of
forfeitures related to service-based vesting conditions. The
assumptions Critical Therapeutics used to calculate the amounts
for Mr. Townsend are discussed in Note 2 to Critical
Therapeutics consolidated financial statements beginning
on page F-8 of this proxy statement/prospectus. |
|
(4) |
|
This column reflects annual bonuses for 2007 by Cornerstone as
described in the section Cornerstones Compensation
Discussion and Analysis Annual Bonuses
beginning on page 302 of this proxy statement/prospectus. |
|
(5) |
|
Represents $33,025 and $14,515 in automobile payments in 2007
for company cars for personal use by Mr. Collard and his
spouse, respectively, $8,726 in country club membership payments
in 2007 and $3,203 in additional payments for employee benefit
plans in 2007. |
310
|
|
|
(6) |
|
Represents $24,395 in automobile payments in 2007 and $2,016 in
additional payments for employee benefit plans in 2007. |
|
(7) |
|
Represents $22,035 in automobile payments in 2007 and $3,203 in
additional payments for employee benefit plans in 2007. |
|
(8) |
|
Mr. Esgro was not employed by Cornerstone during fiscal
2007. Mr. Esgros employment with Cornerstone began in
March 2008, and he has an annual base salary of $220,000. |
|
(9) |
|
Represents $24,995 in automobile payments in 2007 and $3,069 in
additional payments for employee benefit plans in 2007. |
|
(10) |
|
Mr. Price was not employed by Cornerstone during fiscal
2007. Mr. Prices employment with Cornerstone began on
September 8, 2008, and he has an annual base salary of
$285,000. |
|
(11) |
|
Mr. Townsend was employed by Critical Therapeutics during
fiscal 2006 and 2007. |
|
(12) |
|
Includes amounts deferred at the direction of Mr. Townsend
pursuant to Critical Therapeutics 401(k) plan. |
|
(13) |
|
Represents $1,648 in matching contributions to Critical
Therapeutics 401(k) plan that it paid on behalf of
Mr. Townsend in 2007. |
|
(14) |
|
Represents $3,000 in matching contributions to Critical
Therapeutics 401(k) plan that it paid on behalf of
Mr. Townsend in 2006. |
2007
Grants of Plan-Based Awards
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option
|
|
|
Exercise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All Other
|
|
|
Awards:
|
|
|
or Base
|
|
|
Grant Date
|
|
|
|
|
|
|
Estimated Future Payouts Under
|
|
|
Stock Awards;
|
|
|
Number of
|
|
|
Price of
|
|
|
Fair Value
|
|
|
|
|
|
|
Non-Equity Incentive Plan Awards(1)
|
|
|
Number of
|
|
|
Securities
|
|
|
Option
|
|
|
of Stock and
|
|
|
|
|
|
|
Threshold
|
|
|
Target
|
|
|
Maximum
|
|
|
Shares of Stock
|
|
|
Underlying
|
|
|
Awards
|
|
|
Option Awards
|
|
Name
|
|
Grant Date
|
|
|
($)
|
|
|
($)
|
|
|
($)
|
|
|
or Units (#)
|
|
|
Options (#)
|
|
|
($/Sh)
|
|
|
($)
|
|
|
Craig A. Collard
|
|
|
|
|
|
|
|
|
|
|
182,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3/16/2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000,000
|
|
|
|
0.42
|
|
|
|
270,000
|
|
Chenyqua Baldwin
|
|
|
|
|
|
|
|
|
|
|
72,250
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3/16/2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
750,000
|
|
|
|
0.42
|
|
|
|
202,500
|
|
Brian Dickson, M.D.
|
|
|
|
|
|
|
|
|
|
|
91,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3/16/2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
750,000
|
|
|
|
0.42
|
|
|
|
202,500
|
|
George Esgro
|
|
|
|
|
|
|
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven M. Lutz
|
|
|
|
|
|
|
|
|
|
|
80,500
|
(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3/16/2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
750,000
|
|
|
|
0.42
|
|
|
|
202,500
|
|
David Price
|
|
|
|
|
|
|
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott B. Townsend, Esq.
|
|
|
3/16/2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
|
|
|
2.15
|
|
|
|
55,824
|
|
|
|
|
11/5/2007
|
|
|
|
|
|
|
|
82,500
|
(3)
|
|
|
|
|
|
|
25,000
|
|
|
|
|
|
|
|
|
|
|
|
44,975
|
|
|
|
|
(1) |
|
These columns reflect the targeted amounts of the annual bonuses
for 2007 as described in the section Cornerstones
Compensation Discussion and Analysis Annual
Bonuses beginning on page 302 of this proxy
statement/prospectus. |
|
(2) |
|
Equal to 35% of $230,000, the 2007 salary that
Cornerstones board of directors approved for Mr. Lutz
on March 16, 2007. However, because Cornerstones
board of directors placed an administrative condition on Mr.
Lutzs receipt of the $230,000 salary amount, and that
condition was not met, Mr. Lutz received a base salary in
2007 equal to his 2006 annual salary, or $204,000. |
|
(3) |
|
Represents the amount determined by Critical Therapeutics
independent directors as the target annual cash bonus payable to
Mr. Townsend for 2008. Under his current employment
agreement, Mr. Townsend is eligible for an annual cash
bonus in an amount determined by the Compensation Committee of
Critical Therapeutics. On November 5, 2007, based on the
recommendation of the Compensation Committee of Critical
Therapeutics, the independent directors of Critical Therapeutics
established the 2008 annual base salary and the target annual
cash bonus for 2008, as a percentage of annual base salary, for
Mr. Townsend. |
311
|
|
|
|
|
The Compensation Committee of Critical Therapeutics may make
actual cash bonus awards that may be greater or less than the
target annual cash bonus based on overall corporate performance
and individual performance. Company goals of Critical
Therapeutics approved by its board of directors in February 2008
will be considered in determining the actual bonus amount for
Mr. Townsend in respect of the 2008 fiscal year. |
Narrative
Disclosure to Summary Compensation Table and Grants of
Plan-Based Awards Table
Employment
and Related Agreements
Chief
Executive Officer Employment and Related
Agreements
On March 1, 2006, Cornerstone entered into an employment
agreement with Mr. Collard, pursuant to which he serves as
the President and Chief Executive Officer of Cornerstone. The
initial term of the employment agreement continued until
December 31, 2006, with automatic renewal for additional
one-year terms unless the agreement is terminated or either
party gives notice of non-renewal at least 60 days prior to
the end of the then current term. The current renewal term of
the agreement continues until December 31, 2008. Under the
terms of the agreement, Mr. Collard is entitled to an
annual salary, which may be increased from time to time by the
board of directors. If Cornerstone terminates
Mr. Collards agreement other than because of his
death or disability, the liquidation, dissolution or
discontinuance of business by Cornerstone, or for
cause, and if Mr. Collard executes a release and
settlement agreement, he will be entitled to:
|
|
|
|
|
a lump sum payment in an amount equal to 12 months of base
salary, payable 30 days after the termination, and
|
|
|
|
continuation of benefits for the shorter of 12 months, or
until Mr. Collard obtains reasonably comparable benefits
coverage from another employer.
|
Upon termination of Mr. Collards employment,
Cornerstone will pay, or reimburse, Mr. Collard for the
balance of the remaining lease payments on the vehicle provided
by Cornerstone for his use, and will assign and transfer title
and other appropriate evidence of ownership of the vehicle to
Mr. Collard.
On February 8, 2006, Cornerstone and Mr. Collard
entered into an Executive Retention Agreement that provides for
severance benefits under specified circumstances following a
change in control. In the event that Mr. Collards
employment is terminated within 24 months following a
change in control either by Cornerstone without cause, or by
Mr. Collard for good reason, Mr. Collard would be
entitled to receive a lump sum payment consisting of:
|
|
|
|
|
accrued but unpaid base salary, bonus (calculated using
Mr. Collards annual bonus paid or payable for the
then most recently completed fiscal year) and vacation
days; and
|
|
|
|
an amount equal to two times the sum of
(1) Mr. Collards highest annual base salary
during the three-year period prior to the change in control and
(2) Mr. Collards highest annual bonus during the
three-year period prior to the change in control.
|
Any stock options then held by Mr. Collard will also become
immediately exercisable in full, and each outstanding restricted
stock award will become fully vested and no longer subject to a
right of repurchase by Cornerstone. The Executive Retention
Agreement also provides that, upon such a termination,
Mr. Collard will be entitled to 24 months of
continuing benefits, or until he receives comparable benefits
from another employer. In the event that Mr. Collard
resigns without good reason or is terminated due to his death or
disability, he would be entitled to receive accrued but unpaid
base salary, bonus and vacation days. In the event that
Mr. Collard is terminated by Cornerstone for cause, he
would be entitled to receive a lump sum payment consisting of
accrued but unpaid base salary.
On March 1, 2006, Mr. Collard and Cornerstone entered
into a Proprietary Information, Inventions, Non-Competition and
Non-Solicitation Agreement. Pursuant to this agreement,
Mr. Collard agreed not to compete with Cornerstone during
the term of his employment and for a period of one year
following his termination. Mr. Collard also agreed to a
provision that prohibits him from soliciting, among others,
Cornerstones
312
employees and customers during the term of his employment and
for one year following termination of employment. The agreement
also contains customary confidentiality provisions, and
provisions relating to the assignment of inventions.
Employment
and Related Agreements with Other Executive Officers of
Cornerstone Who Will Become Executive Officers of the Combined
Company
Cornerstone is currently a party to employment agreements with
Ms. Baldwin, Dr. Dickson, Mr. Esgro, Mr. Lutz and
Mr. Price.
Pursuant to their respective employment agreements, each of
Ms. Baldwin, Dr. Dickson and Mr. Lutz serves as
an executive officer of Cornerstone. The initial term of
Ms. Baldwins, Dr. Dicksons and
Mr. Lutzs employment agreements continued until
December 31, 2006, with automatic renewal for additional
one-year terms unless the agreement is terminated or either
party gives notice of non-renewal at least 60 days prior to
the end of the term. The current renewal term of each agreement
continues until December 31, 2008. Each executive officer
is entitled to a minimum base salary and is eligible to receive
an annual bonus as determined by Cornerstones board of
directors. If Cornerstone terminates Ms. Baldwins,
Mr. Dicksons or Mr. Lutzs agreement other
than because of the executive officers death or
disability, the liquidation, dissolution or discontinuance of
business by Cornerstone or for cause, and if the
executive officer executes a release and settlement agreement,
the executive officer will be entitled to:
|
|
|
|
|
a lump sum payment in an amount equal to three months of base
salary (six months in the case of Mr. Lutz), payable
30 days after the termination; and
|
|
|
|
continuation of benefits for the shorter of three months (six
months in the case of Mr. Lutz), or until the executive
officer obtains reasonably comparable benefits coverage from
another employer.
|
Upon termination of Mr. Lutzs employment, Cornerstone
will pay, or reimburse, Mr. Lutz for the balance of the
remaining lease payments on the vehicle provided by Cornerstone
for his use, and will assign and transfer title and other
appropriate evidence of ownership of the vehicle to
Mr. Lutz.
Ms. Baldwin, Dr. Dickson, and Mr. Lutz each
entered into Proprietary Information, Inventions,
Non-Competition and Non-Solicitation Agreements, which contain
non-compete, non-solicit, invention assignment, and
confidentiality provisions, which are identical to those
contained in Mr. Collards Proprietary Information,
Inventions, Non-Competition and Non-Solicitation Agreement.
Mr. Esgro has also entered into an employment agreement
with Cornerstone. Mr. Esgros agreement is for an
indefinite term, terminable either by Mr. Esgro or
Cornerstone at any time. Mr. Esgros agreement does
not provide for severance payment in the event of his
termination. In the event of a change in control of Cornerstone,
Mr. Esgros employment agreement provides that any
rights in Cornerstones stock, stock options, benefits or
otherwise that are unvested and would have become vested through
the passage of time will immediately vest. For purposes of
Mr. Esgros employment agreement only, a change in
control is defined as the transfer of greater than 50% of the
common ownership of Cornerstone to an unrelated third party.
Mr. Esgros employment agreement prohibits him from
competing with Cornerstone during the term of his employment and
for one year thereafter, and also contains standard non-solicit,
confidentiality and invention assignment provisions.
Mr. Price has entered into an employment agreement with
Cornerstone pursuant to which he became Executive Vice
President, Finance, and Chief Financial Officer of Cornerstone,
effective September 8, 2008. The initial term of
Mr. Prices employment agreement will continue until
September 8, 2009, with automatic renewal for additional
one-year terms unless the agreement is terminated or either
party gives notice of non-renewal at least 60 days prior to
the end of the term. The agreement provides for (i) an
annual salary of $285,000, subject to annual increases as
determined by the board of directors; (ii) an annual target
cash bonus of up to 35% of his then annual base salary;
(iii) an initial restricted stock grant under the 2005
Stock Incentive Plan of 1,301,776 shares of
Cornerstones common stock; and (iv) reimbursement of
up to $20,000 for reasonable moving expenses.
313
If Mr. Prices employment is terminated by Cornerstone
without cause or by Mr. Price for good reason, and he
executes and does not revoke a severance agreement and release
of all claims, he will be entitled to:
|
|
|
|
|
a lump sum payment in an amount equal to six months of base
salary, payable 30 days after the termination; and
|
|
|
|
COBRA premiums for health and dental insurance (if
Mr. Price continues health and dental insurance under
COBRA), and payments equal to the premiums paid by Cornerstone
for Mr. Prices life and disability insurance in the
month preceding the termination. Mr. Price will receive
these payments until the earlier of six months or until the last
day of the first month that Mr. Price is eligible for other
employer-sponsored health coverage.
|
Pursuant to his employment agreement, Mr. Price agreed not
to compete with Cornerstone during the term of his employment
and for a period of one year thereafter. Mr. Price also
agreed to a provision that prohibits him from soliciting, among
others, Cornerstones employees and customers during the
same period. The employment agreement also contains customary
confidentiality provisions and provisions relating to the
assignment of inventions.
Employment
and Related Agreements with Mr. Townsend
Agreements
Prior to Closing of the Merger
On December 21, 2004, Critical Therapeutics entered into an
employment agreement with Mr. Townsend, and in November
2007, Critical Therapeutics entered into an amended and restated
employment agreement with Mr. Townsend.
Mr. Townsends employment agreement has an initial
term that extends through December 31, 2009. The employment
agreement automatically extends for an additional one-year term
after the initial term unless either Critical Therapeutics or
the executive officer gives
90-days
prior notice.
Under his employment agreement, Mr. Townsend is paid a base
salary and is eligible for an annual cash bonus of a specified
percentage of his annual base salary and an annual equity award.
Mr. Townsends employment agreement in effect as of
December 31, 2007 provides for an initial annual base
salary of $245,000 and an annual target cash bonus as a
percentage of base salary of 30%.
The actual amount of any cash bonus or equity award is
determined by the Compensation Committee of Critical
Therapeutics. The Compensation Committee may make actual cash
bonus awards that may be greater or less than the annual target
cash bonus based on overall corporate performance and individual
performance. Although generally none of Critical
Therapeutics executive officers is guaranteed either an
annual cash bonus or an annual equity award, each of the
executive officers of Critical Therapeutics was entitled to a
minimum cash bonus for the year ended December 31, 2007 if
he remained employed with Critical Therapeutics through
December 31, 2007. Mr. Townsends employment
agreement in effect as of December 31, 2007 provides for a
minimum cash bonus for 2007 of $73,500.
For more information regarding Critical Therapeutics
executive compensation process and the elements of executive
compensation, see the section Critical Therapeutics
Compensation Discussion and Analysis beginning on
page 303 of this proxy statement/prospectus.
Mr. Townsends employment agreement with Critical
Therapeutics provides that if Critical Therapeutics terminates
his employment other than for cause or if he
terminates his employment for good reason, in each
case as those terms are defined in his employment agreement,
then Critical Therapeutics is obligated to provide the following
to Mr. Townsend, provided he executes and delivers to
Critical Therapeutics a severance agreement and release drafted
by and satisfactory to counsel to Critical Therapeutics:
|
|
|
|
|
a lump sum payment equal to his annual base salary in effect at
that time;
|
|
|
|
monthly payments in the amount of 100% of the monthly COBRA
premiums for continued health and dental coverage for
Mr. Townsend and his dependents, and 100% of the amount of
the monthly premiums paid by Critical Therapeutics for life
insurance and disability insurance for Mr. Townsend
|
314
|
|
|
|
|
until the earlier of one year after termination or the last day
of the first month when Mr. Townsend is eligible for
benefits through other employment;
|
|
|
|
|
|
a pro rata payment of his target cash bonus in effect in the
year of termination; and
|
|
|
|
accelerated vesting of 50% of his outstanding unvested stock
options and restricted stock.
|
Immediately upon a change of control of Critical
Therapeutics, as defined in his employment agreement,
Mr. Townsend is entitled to accelerated vesting of 50% of
all his outstanding unvested stock options and restricted stock.
If Critical Therapeutics terminates Mr. Townsends
employment other than for cause or if
Mr. Townsend terminates his employment for good
reason during the period from three months before until
one year after the occurrence of a change of control, then
Critical Therapeutics is obligated to provide the following to
Mr. Townsend, provided he executes and delivers to Critical
Therapeutics a severance agreement and release drafted by and
satisfactory to counsel to Critical Therapeutics:
|
|
|
|
|
a lump sum payment equal to his annual base salary in effect at
that time;
|
|
|
|
monthly payments in the amount of 100% of the monthly COBRA
premiums for continued health and dental coverage for
Mr. Townsend and his dependents, and 100% of the amount of
the monthly premiums paid by Critical Therapeutics for life
insurance and disability insurance for Mr. Townsend until
the earlier of one year after termination or the last day of the
first month when Mr. Townsend is eligible for benefits
through other employment;
|
|
|
|
a pro rata payment of his target cash bonus in effect in the
year of termination;
|
|
|
|
accelerated vesting of 100% of his outstanding unvested stock
options and restricted stock; and
|
|
|
|
up to three months of outplacement services.
|
Upon voluntary resignation, Mr. Townsend is entitled to a
pro rata payment of his annual bonus from the previous year
provided that he gives
90-days
prior written notice of resignation and executes a release of
Critical Therapeutics.
Mr. Townsend has agreed not to compete with Critical
Therapeutics during his employment with the company and for a
one-year period after termination of employment by Critical
Therapeutics for any reason or after a change of
control of Critical Therapeutics. In the event of a breach
of this non-competition obligation, Critical Therapeutics will
be entitled to injunctive relief in addition to any other
remedies it might have, and Mr. Townsend will continue to
be held to the obligation until the requisite time period has
passed without any violation. Mr. Townsend has also agreed
not to disclose any confidential information obtained during his
employment. The severance agreements and releases used by
Critical Therapeutics typically contain provisions, whereby a
departing executive reaffirms these obligations, and
non-disparagement clauses of perpetual duration, compliance with
which is a condition to the receipt of payments.
Agreements
Following the Closing of the Merger
In anticipation of Mr. Townsends service to the
combined company following the merger, on September 16,
2008, Critical Therapeutics entered into an amendment to the
amended and restated employment agreement between Critical
Therapeutics and Mr. Townsend. This amendment will be
effective from the effective time of the merger to
December 31, 2010 and will only become effective if the
merger is consummated. Under the terms of this amendment,
Mr. Townsend will serve as the General Counsel, Executive
Vice President of Legal Affairs and Secretary of the combined
company. Except as specifically described below, the material
terms of Mr. Townsends employment agreement described
above will continue to be in effect after the amendment to his
employment agreement becomes effective.
The amendment provides for an increase in
Mr. Townsends annual target cash bonus as a
percentage of base salary from 30% to 35% and an actual annual
cash bonus for Mr. Townsend for 2008 of not less than 35%
of his base salary if he remains an employee in good standing
through December 31, 2008. Mr. Townsend will
315
continue to receive an annual base salary of $275,000.
Mr. Townsend also will be eligible to participate in all of
the combined companys benefit plans and programs,
including a car allowance, as provided to other vice president
or executive vice president level executives at Cornerstone.
Because it is expected that Mr. Townsend may, for some
period of time, continue to reside in Massachusetts following
the relocation of the combined company to North Carolina,
Mr. Townsend also will be reimbursed for related business
travel expenses and temporary lodging while in North Carolina
and expenses related to a home office in Massachusetts.
The amendment specifically recognizes that the relocation of the
combined company to North Carolina constitutes good
reason under Mr. Townsends current amended and
restated employment agreement. If, under the amendment to
Mr. Townsends employment agreement, his employment is
terminated at any time on or before December 31, 2009 by
the combined company without cause, by
Mr. Townsend for good reason or because of
Mr. Townsends death or disability, he or his estate,
as applicable, would be entitled to:
|
|
|
|
|
a lump sum payment equal to his annual base salary in effect at
that time;
|
|
|
|
monthly payments in the amount of 100% of the monthly COBRA
premiums for continued health and dental coverage for
Mr. Townsend and his dependents, and 100% of the amount of
the monthly premiums paid by the combined company for life
insurance and disability insurance for Mr. Townsend until
the earlier of one year after termination or the last day of the
first month when Mr. Townsend is eligible for benefits
through other employment;
|
|
|
|
a pro rata payment of his target cash bonus in effect in the
year of termination;
|
|
|
|
accelerated vesting of 100% of his outstanding unvested stock
options and restricted stock, provided that (i) if
Mr. Townsend resigns for good reason related to
the relocation of his place of business from Massachusetts to
North Carolina, then the accelerated vesting of his outstanding
unvested stock options and restricted stock will not include
restricted stock granted pursuant to the restricted stock
agreement dated September 16, 2008, as described below, and
(ii) if Mr. Townsends employment is terminated
by the combined company without cause, then vesting
will accelerate with respect to 35% of the restricted stock
granted pursuant to the restricted stock agreement dated
September 16, 2008, unless such termination is during a
change of control period relating to a transaction
other than the merger with Cornerstone, in which case, the
vesting will accelerate with respect to 100% of the restricted
stock granted pursuant to the restricted stock agreement entered
into dated September 16, 2008; and
|
|
|
|
up to three months of outplacement services, except in the event
of Mr. Townsends death.
|
In connection with such amendment, on September 16, 2008,
Critical Therapeutics also entered into a restricted stock
agreement with Mr. Townsend that provides for a restricted
stock grant to Mr. Townsend on the first business day after
the consummation of the merger of a number of shares of common
stock representing one percent of the combined companys
outstanding equity, on a fully diluted basis but excluding an
aggregate of 7,208,707 shares of Critical
Therapeutics common stock underlying warrants issued in
connection with a June 2005 private placement and an October
2006 registered offering, after giving effect to the reverse
stock split and the merger, subject to the terms of such
restricted stock agreement. The restricted stock agreement will
only become effective if the merger is consummated. It is
expected that approximately 1,489,789 shares will be issued
to Mr. Townsend pursuant to the restricted stock agreement,
subject to adjustment as a result of the reverse stock split.
This restricted stock award will vest as to 25% of the shares
subject to the award on May 1, 2009, 25% of the shares on
May 1, 2010, 25% of the shares on May 1, 2011 and 25%
of the shares on May 1, 2012.
Definitions
For purposes of Mr. Collards Executive Retention
Agreement and each of Ms. Baldwins,
Mr. Dicksons and Mr. Lutzs respective
employment agreements, the terms below have the following
meanings:
change in control means either one or more of the
events or occurrences set below:
|
|
|
|
|
an acquisition of ownership of stock of Cornerstone by any one
person or group that, together with stock previously held by
such person or group, constitutes more than 50% of the total
fair market
|
316
|
|
|
|
|
value or total voting power of the stock of Cornerstone;
provided however, that the following acquisitions are not a
change in control: (i) any acquisition of ownership of
stock of Cornerstone for the primary purpose of a debt or equity
financing of Cornerstone; or (ii) the acquisition of any
stock of Cornerstone by any person that is a stockholder of
Cornerstone on February 8, 2006; or (iii) any
acquisition in which Cornerstone becomes a subsidiary of another
corporation and in which the stockholders of Cornerstone
immediately prior to the transaction will own, immediately after
the transaction, shares entitling such stockholders to more than
50% of all votes to which all stockholders of the parent
corporation would be entitled in the election of directors; and
|
|
|
|
|
|
an acquisition by any one person, or more than one person acting
as a group, of assets of Cornerstone that have a total gross
fair market value equal to or more than 90% of the total gross
fair market value of all of the assets of Cornerstone
immediately prior to the acquisition; provided, however, that
any acquisition of any assets of Cornerstone by any person or
group that was a stockholder of Cornerstone on February 8,
2006 does not constitute a change in control.
|
cause or for cause means:
|
|
|
|
|
breach of the executive officers employment agreement or
failure to diligently and properly perform his or her duties;
|
|
|
|
misappropriation or unauthorized use of Cornerstones
property or breach of his or her Proprietary Information,
Inventions, Non-Competition and Non-Solicitation Agreement;
|
|
|
|
failure to company with Cornerstones policies
and/or
directives of the board of directors;
|
|
|
|
use of illegal drugs or any illegal substance, or the use of
alcohol in a manner detrimental to the performance of duties;
|
|
|
|
dishonest or illegal action that is detrimental to Cornerstone;
|
|
|
|
failure to fully disclose material conflicts of interest;
|
|
|
|
any adverse action or omission that would be required to be
disclosed pursuant to public securities laws or that would limit
the ability of Cornerstone or any entity affiliated with
Cornerstone to sell securities or cause Cornerstone to be
disqualified from an exemption otherwise available; or
|
|
|
|
violation of Cornerstones policies prohibiting harassment,
unlawful discrimination, retaliation or workplace violence.
|
good reason means the occurrence, without the
executive officers written consent, of any of the events
or circumstances below:
|
|
|
|
|
the assignment of duties inconsistent with the officers
position;
|
|
|
|
reduction in annual base salary;
|
|
|
|
failure to: (i) continue material compensation or benefit
plans or programs, (ii) continue the executive
officers participation in such plans, or (iii) award
bonuses to the executive officer substantially consistent with
past practice;
|
|
|
|
requiring the executive officer to be based more than
50 miles from his or her location immediately prior to the
change in control, or requiring the executive officer to travel
on business to a substantially greater extent than immediately
prior to the change in control;
|
|
|
|
Cornerstones failure to obtain a satisfactory agreement
from any successor to assume and agree to perform the agreement;
or
|
|
|
|
the failure of Cornerstone to pay or provide to the executive
officer any portion of his compensation or benefits due within
10 days of being due, or any material breach of the
executive officers employment agreement or Executive
Retention Agreement.
|
317
For purposes of Mr. Prices employment agreement only, the
terms below have the following meanings:
cause means:
|
|
|
|
|
failure to perform material responsibilities to Cornerstone;
|
|
|
|
misconduct that is materially injurious to Cornerstone;
|
|
|
|
a determination by Cornerstone within thirty days of
Mr. Prices resignation that discharge under either of
the above was warranted; or
|
|
|
|
a material breach of the employment agreement by Mr. Price.
|
good reason means:
|
|
|
|
|
any material reduction in the annual base compensation payable
to Mr. Price (but exclusive of any cash bonus, annual
equity award or other similar cash bonus or equity plans);
|
|
|
|
relocation of the Cornerstones place of business at which
Mr. Price is principally located to a location that is
greater than 50 miles from its current location;
|
|
|
|
failure of Cornerstone to comply with a material term of
Mr. Prices employment agreement; or
|
|
|
|
significant reduction in the Mr. Prices duties,
responsibilities or position.
|
For purposes of Mr. Townsends employment agreement
only, the terms below have the following meanings:
cause means:
|
|
|
|
|
failure to perform material responsibilities to Critical
Therapeutics;
|
|
|
|
misconduct that is materially injurious to Critical
Therapeutics, or a determination by Critical Therapeutics within
thirty days of Mr. Townsends resignation that
discharge for such misconduct was warranted; or
|
|
|
|
a material breach by Mr. Townsend of the non-competition or
the proprietary information and developments sections of the
employment agreement.
|
good reason means:
|
|
|
|
|
any material reduction in the annual base compensation payable
to Mr. Townsend (but exclusive of any cash bonus, annual
equity award or other similar cash bonus or equity plan);
|
|
|
|
relocation of the place of business at which Mr. Townsend
is principally located to a location that is greater than thirty
(30) miles from its current location;
|
|
|
|
failure of Critical Therapeutics to comply with a material term
of Mr. Townsends employment agreement; or
|
|
|
|
significant reduction in the Mr. Townsends duties,
responsibilities or position.
|
change of control means:
|
|
|
|
|
an acquisition of beneficial ownership of stock of Critical
Therapeutics by any individual, entity or group such that after
the acquisition such person(s) beneficially owns 50% or more of
the combined voting power of the then-outstanding securities of
Critical Therapeutics entitled to vote generally in the election
of directors; provided, however, that the following acquisitions
are not a change of control: (i) any acquisition directly
from Critical Therapeutics or (ii) acquisitions in
connection with certain mergers or consolidations;
|
|
|
|
a majority of Critical Therapeutics board is replaced by
directors who are not elected or recommended for election by a
majority of Critical Therapeutics board;
|
318
|
|
|
|
|
Critical Therapeutics consummates a merger, consolidation,
reorganization, recapitalization or share exchange, or a sale or
other disposition of all or substantially all of the assets of
Critical Therapeutics, unless certain conditions are met; or
|
|
|
|
the liquidation or dissolution of Critical Therapeutics.
|
change of control period means the period from
3 months before until 1 year after the date on which a
change of control occurs.
2005
Stock Incentive Plan
On December 23, 2005, Cornerstones board of directors
adopted the 2005 Stock Incentive Plan pursuant to which awards
may be made under the plan for up to 10,000,000 shares of
Cornerstones common stock. The plan permits
Cornerstones board of directors to grant awards, including
stock options and restricted stock, to participants.
Cornerstones board may establish vesting and performance
requirements for any grant. Cornerstones board of
directors may amend or terminate the 2005 Stock Incentive Plan
at any time. Historically, most grants of equity securities
under the 2005 Stock Incentive Plan have been in the form of
stock options.
Stock option grants awarded under the 2005 Stock Incentive Plan
are subject to adjustments in the event of a change in
Cornerstones capitalization, liquidation, dissolution,
reorganization or change in control.
In the event of a change in Cornerstones capitalization,
such as a stock split, reverse stock split, stock dividend,
recapitalization, combination of shares, reclassification of
shares, spin-off or other similar change in capitalization or
event, or any distribution to holders of Cornerstones
common stock other than an ordinary cash dividend, the board of
directors may adjust the terms of option grants, including the
number and class of securities and exercise price per share of
each outstanding option.
In the event of a proposed liquidation or dissolution of
Cornerstone, the plan requires the board of directors, upon
written notice to the plan participants, to provide that all
then unexercised options will become exercisable in full as of a
specified time at least 10 business days prior to the effective
date of such liquidation or dissolution and terminate effective
upon such liquidation or dissolution, except to the extent
exercised before such effective date.
Upon the occurrence of a reorganization event of Cornerstone,
the plan requires that the board of directors shall provide that
all outstanding options shall be assumed, or equivalent options
shall be substituted, by the acquiring or succeeding corporation
(or an affiliate thereof); provided that if such reorganization
event also constitutes a change in control event, such assumed
or substituted options shall become immediately exercisable in
full if, on or prior to the twelve-month anniversary of the date
of the consummation of the reorganization event, the plan
participants employment with Cornerstone or the acquiring
or succeeding corporation is terminated for good reason by the
plan participant or is terminated without cause by Cornerstone
or the acquiring or succeeding corporation.
Upon the occurrence of a change in control event that does not
also constitute a reorganization event, each then-outstanding
option shall continue to become vested in accordance with the
original vesting schedule set forth in such option; provided,
however, that each such option shall become immediately
exercisable in full if, on or prior to the twelve-month
anniversary of the date of the consummation of the change in
control event, the plan participants employment with
Cornerstone or the acquiring or succeeding corporation is
terminated for good reason by the Participant or is terminated
without cause by Cornerstone or the acquiring or succeeding
corporation.
319
Definitions
For purposes of the 2005 Stock Incentive Plan, the terms below
have the following meanings:
A reorganization event means:
|
|
|
|
|
any merger or consolidation of Cornerstone with or into another
entity as a result of which all of the common stock of
Cornerstone is converted into or exchanged for the right to
receive cash, securities or other property; or
|
|
|
|
any exchange of all of the common stock of Cornerstone for cash,
securities or other property pursuant to a share exchange
transaction.
|
A change in control event means:
|
|
|
|
|
the acquisition by any person (which could be an
individual, entity or group) of more than 50% of the outstanding
common stock or voting securities of Cornerstone, except for
acquisitions directly from Cornerstone or in connection with
certain mergers or consolidations;
|
|
|
|
a majority of Cornerstones board is replaced by directors
who are not elected or recommended for election by
Cornerstones board; or
|
|
|
|
Cornerstone consummates certain mergers or consolidations.
|
good reason means:
|
|
|
|
|
a significant diminution in the plan participants title,
authority or responsibilities;
|
|
|
|
reduction in annual cash compensation; or
|
|
|
|
relocation of the plan participants place of business more
than 50 miles from the current site.
|
cause means:
|
|
|
|
|
willful failure by the plan participant to perform his or her
material responsibilities; or
|
|
|
|
willful misconduct by the plan participant that affects the
business reputation of Cornerstone.
|
Stock
Option and Restricted Stock Grants
As reported in the section 2007 Grants of Plan-Based
Awards beginning on page 311 of this proxy
statement/prospectus, Cornerstone granted stock options to its
executive officers on March 16, 2007. These stock options
awards will vest in 25% increments on the anniversary of the
date of the grant in 2008, 2009, 2010 and 2011.
Also as reported in the section 2007 Grants of Plan-Based
Awards beginning on page 311 of this proxy
statement/prospectus, Critical Therapeutics has granted stock
options to Mr. Townsend during 2007. All stock options
granted during 2007 to Mr. Townsend vest as to 25% of the
shares on the first anniversary of the grant date and as to the
remaining shares in 36 approximately equal monthly installments
beginning one month thereafter. All stock options are granted
with an exercise price equal to the closing price per share of
Critical Therapeutics common stock reported by NASDAQ on
the grant date.
On September 16, 2008, Critical Therapeutics
independent directors approved the grant of restricted stock
awards for shares of Critical Therapeutics common stock
under Critical Therapeutics 2004 Stock Incentive Plan, as
amended, to Mr. Townsend, subject to the terms of a
restricted stock agreement that it entered into with
Mr. Townsend. The restricted stock agreement provides for a
restricted stock grant to Mr. Townsend on the first
business day after the consummation of the merger of a number of
shares of common stock representing one percent of the combined
companys outstanding equity, on a fully diluted basis but
excluding an aggregate of 7,208,707 shares of Critical
Therapeutics common stock underlying warrants issued in
connection with a June 2005 private placement and an October
2006 registered offering, after giving effect to the reverse
stock split and the merger, subject to the terms of such
restricted stock agreement. The restricted stock agreement will
only become effective if the merger is consummated. It is
expected that approximately
320
1,489,789 shares will be issued to Mr. Townsend
pursuant to the restricted stock agreement, subject to
adjustment as a result of the reverse stock split. This
restricted stock award will vest as to 25% of the shares subject
to the award on May 1, 2009, 25% of the shares on
May 1, 2010, 25% of the shares on May 1, 2011 and 25%
of the shares on May 1, 2012.
On November 5, 2007, based on the recommendation of the
Compensation Committee, Critical Therapeutics independent
directors approved the grant of restricted stock awards for
shares of Critical Therapeutics common stock under
Critical Therapeutics 2004 Stock Incentive Plan, as
amended, to Mr. Townsend for a purchase price of $0.001 per
share, subject to the terms of a restricted stock agreement that
it entered into with Mr. Townsend. Critical Therapeutics
granted 25,000 shares of common stock to Mr. Townsend,
effective as of November 5, 2007. The shares of common
stock subject to the awards vested as to 50% of the shares in
May 2008 and vest as to the balance on the second anniversary of
the grant date. Critical Therapeutics granted 35,000 shares
of common stock to Mr. Townsend, effective as of
February 14, 2008. The shares of common stock subject to
the award vested as to 50% of the shares in August 2008 and vest
as to the balance on the second anniversary of the grant date.
On December 19, 2006, based on the recommendation of the
Compensation Committee, Critical Therapeutics independent
directors approved the grant of restricted stock awards for
shares of Critical Therapeutics common stock to
Mr. Townsend for a purchase price of $0.001 per share,
subject to the terms of a restricted stock agreement that it
entered into with its executive officers. Critical Therapeutics
granted 26,700 shares of common stock to Mr. Townsend,
effective as of December 27, 2006. The shares of common
stock subject to the award vested as to 50% of the shares in
December 2007 and vest as to the balance on the second
anniversary of the grant date.
Critical Therapeutics board of directors has approved a
tax withholding right that allows employees to satisfy any tax
withholding obligations that occur upon the vesting of
restricted stock by means of a deemed disposition to Critical
Therapeutics of a portion of the restricted shares that are
scheduled to vest. Critical Therapeutics deducts and retains the
applicable number of shares from the number of restricted shares
that are scheduled to vest.
321
2007
Outstanding Equity Awards at Fiscal Year-End
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPTION AWARDS (1)
|
|
|
|
STOCK AWARDS
|
|
|
|
|
Number of
|
|
Number of
|
|
|
|
|
|
Number of
|
|
Market Value
|
|
|
|
|
Securities
|
|
Securities
|
|
|
|
|
|
Shares or
|
|
of Shares
|
|
|
|
|
Underlying
|
|
Underlying
|
|
|
|
|
|
Units of
|
|
or Units of
|
|
|
|
|
Unexercised
|
|
Unexercised
|
|
Option
|
|
|
|
Stock That
|
|
Stock That
|
|
|
|
|
Options
|
|
Options
|
|
Exercise
|
|
Option
|
|
Have Not
|
|
Have Not
|
|
|
|
|
(#)
|
|
(#)
|
|
Price
|
|
Expiration
|
|
Vested
|
|
Vested
|
|
|
Name
|
|
Exercisable
|
|
Unexercisable
|
|
($/Sh)
|
|
Date
|
|
(#)
|
|
($)
|
|
|
|
Craig A. Collard
|
|
|
50,000
|
(2)
|
|
|
|
|
|
$
|
0.10
|
|
|
|
8/1/2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,000,000
|
|
|
$
|
0.42
|
|
|
|
3/16/2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chenyqua Baldwin
|
|
|
12,500
|
|
|
|
37,500
|
|
|
$
|
0.10
|
|
|
|
2/23/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
750,000
|
|
|
$
|
0.42
|
|
|
|
3/16/2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
187,500
|
(3)
|
|
|
|
(4)
|
|
|
|
|
Brian Dickson, M.D.
|
|
|
206,250
|
(5)
|
|
|
68,750
|
|
|
$
|
0.10
|
|
|
|
5/9/2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75,000
|
(6)
|
|
|
75,000
|
|
|
$
|
0.10
|
|
|
|
8/1/2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
81,250
|
(7)
|
|
|
243,750
|
|
|
$
|
0.10
|
|
|
|
8/1/2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
750,000
|
|
|
$
|
0.42
|
|
|
|
3/16/2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
George Esgro(8)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven Lutz
|
|
|
18,750
|
|
|
|
6,250
|
(10)
|
|
$
|
0.25
|
|
|
|
7/1/2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37,500
|
|
|
|
112,500
|
|
|
$
|
0.10
|
|
|
|
2/23/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
750,000
|
|
|
$
|
0.42
|
|
|
|
3/16/2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Price(9)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott B. Townsend, Esq.(11)
|
|
|
61,500
|
|
|
|
12,500
|
(12)
|
|
|
4.84
|
|
|
|
8/19/2014
|
|
|
|
13,350
|
(13)
|
|
|
16,955
|
(15)
|
|
|
|
|
|
|
|
10,937
|
|
|
|
4,063
|
(12)
|
|
|
7.75
|
|
|
|
1/20/2015
|
|
|
|
25,000
|
(14)
|
|
|
31,750
|
(15)
|
|
|
|
|
|
|
|
19,166
|
|
|
|
20,834
|
(12)
|
|
|
7.12
|
|
|
|
1/2/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,750
|
|
|
|
31,250
|
(12)
|
|
|
3.80
|
|
|
|
6/24/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,250
|
|
|
|
18,750
|
(12)
|
|
|
1.88
|
|
|
|
12/26/2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
(12)
|
|
|
2.15
|
|
|
|
3/16/2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Except as otherwise noted, the option awards reflected in these
columns will vest in 25% increments on each of the first,
second, third, and fourth anniversary of the date of the
grant. The date of grant for each of these options is the date
10 years prior to the expiration date reflected in this
table. |
|
(2) |
|
Option award vested immediately on January 17, 2006, the
date of grant. |
|
(3) |
|
The vesting schedule for this restricted stock award is 25% on
July 13, 2005, 25% on July 13, 2006, 25% on
July 13, 2007 and 25% on July 13, 2008. |
|
(4) |
|
Cornerstone is a private company and no public market exists for
its common stock. |
|
(5) |
|
The vesting schedule for this option award is 25% on
December 1, 2005, 25% on December 1, 2006, 25% on
December 1, 2007, and 25% on December 1, 2008. The
date of grant for this award was January 17, 2006. |
|
(6) |
|
The vesting schedule for this option award is 25% on
August 1, 2006, 25% on August 1, 2007, 25% on
August 1, 2008 and 25% on August 1, 2009. The date of
grant for this award was January 17, 2006. |
|
(7) |
|
The vesting schedule for this option award is 25% on
February 9, 2007, 25% on February 9, 2008, 25% on
February 9, 2009, and 25% on February 9, 2010. The
date of grant for this award was February 8, 2006. |
|
(8) |
|
Mr. Esgro was not employed by Cornerstone on
December 31, 2007. Mr. Esgros employment with
Cornerstone began in March 2008. |
|
(9) |
|
Mr. Price was not employed by Cornerstone on
December 31, 2007. Mr. Prices employment with
Cornerstone began on September 8, 2008. |
322
|
|
|
(10) |
|
The vesting schedule for this option award is 25% on
December 1, 2005, 25% on December 1, 2006, 25% on
December 1, 2007 and 25% on December 1, 2008. The date
of grant for this award was July 1, 2005. |
|
(11) |
|
All references to options or shares held by Mr. Townsend
refer to options or shares of Critical Therapeutics. References
to options or shares held by all other executive officers in the
table refer to options or shares of Cornerstone. |
|
(12) |
|
Shares subject to these options vest as to 25% of such shares on
the first anniversary of the date of grant and as to the
remaining shares in 36 approximately equal monthly installments
beginning one month thereafter. The date of grant for each of
these options is the date 10 years prior to the expiration
date reflected in this table. Share numbers give effect to
shares already vested as of December 31, 2007, which are
reflected in the previous column. |
|
(13) |
|
The shares reflected represent restricted stock awards of
Critical Therapeutics that vest on December 27, 2008. |
|
(14) |
|
The shares reflected represent restricted stock awards of
Critical Therapeutics that vest as to 50% of the shares subject
thereto on May 5, 2008 and as to the remaining 50% of the
shares subject thereto on November 5, 2009. |
|
(15) |
|
These amounts are calculated based on a price per share of
$1.27, the closing market price per share of Critical
Therapeutics common stock on December 31, 2007, the
last business day of the year. |
2007
Option Exercises and Stock Vested
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPTION AWARDS
|
|
STOCK AWARDS
|
|
|
Number of Shares
|
|
Value Realized on
|
|
Number of Shares
|
|
Value Realized on
|
|
|
Acquired on Exercise
|
|
Exercise
|
|
Acquired on Vesting
|
|
Vesting
|
Name
|
|
(#)
|
|
($)
|
|
(#)
|
|
($)
|
|
Craig A. Collard
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chenyqua Baldwin
|
|
|
|
|
|
|
|
|
|
|
187,500
|
|
|
|
|
(1)
|
Brian Dickson, M.D.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
George Esgro(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven M. Lutz
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Price(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott B. Townsend, Esq.(4)
|
|
|
|
|
|
|
|
|
|
|
13,350
|
|
|
|
17,075(5
|
)
|
|
|
|
(1) |
|
Cornerstone is a private company and no public market exists for
its common stock. |
|
(2) |
|
Mr. Esgro was not employed by Cornerstone on
December 31, 2007. Mr. Esgros employment with
Cornerstone began in March 2008. |
|
(3) |
|
Mr. Price was not employed by Cornerstone on
December 31, 2007. Mr. Prices employment with
Cornerstone began on September 8, 2008. |
|
(4) |
|
All references to shares held by Mr. Townsend refer to
shares of Critical Therapeutics. References to shares held by
all other executive officers in the table refer to shares of
Cornerstone. |
|
(5) |
|
Calculated by multiplying the number of vested shares by the
closing market price per share of Critical Therapeutics
common stock on the vesting date or, if the vesting date is not
a business day, on the previous business day. |
Potential
Payments upon Termination or Change in Control with Respect to
Cornerstones Executive Officers
Cornerstone has entered into employment
and/or
retention agreements with each of its executive officers. These
agreements provide for payments and benefits to the executive
officer upon termination of employment or a change of control of
Cornerstone under specified circumstances. In addition, the 2005
Equity Incentive
323
Plan provides for accelerated vesting of equity awards under
specified circumstances following a change in control. For
information regarding the specific circumstances that would
trigger payments and the provision of benefits, the manner in
which payments and benefits would be provided and conditions
applicable to the receipt of payments and benefits, see
Narrative Disclosure to Summary Compensation Table and
Grants of Plan-Based Awards Table beginning on
page 312 of this proxy statement/prospectus.
The following tables set forth information regarding potential
payments and benefits that each executive officer would receive
upon termination of employment or a change of control of
Cornerstone under specified circumstances, assuming that the
triggering event in question occurred on December 31, 2007,
the last business day of the fiscal year.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Termination without Cause Prior to
|
|
|
|
|
Change in Control
|
|
Any Termination of Employment
|
Name
|
|
Cash Payments
|
|
Value of Benefits
|
|
Other
|
|
Craig A. Collard
|
|
$
|
365,000
|
|
|
$
|
12,813
|
|
|
$
|
87,277
|
(1)
|
Chenyqua Baldwin
|
|
$
|
53,750
|
|
|
$
|
2,016
|
|
|
|
|
|
Brian Dickson, M.D.
|
|
$
|
65,000
|
|
|
$
|
3,204
|
|
|
|
|
|
George Esgro(2)
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven M. Lutz
|
|
$
|
102,000
|
|
|
$
|
6,138
|
|
|
$
|
38,651
|
(1)
|
David Price(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Payment reflects that upon termination of the executive
officers employment, Cornerstone will pay, or reimburse,
the executive officer for the balance of the remaining lease
payments on the vehicle provided by Cornerstone for the
executive officers use, and will assign and transfer title
and other appropriate evidence of ownership of the vehicle to
the executive officer. These payments are in addition to any
other payments the executive officer would receive in connection
with a termination of employment. |
|
(2) |
|
Mr. Esgro was not employed by Cornerstone on
December 31, 2007. Mr. Esgros employment with
Cornerstone began in March 2008. |
|
(3) |
|
Mr. Price was not employed by Cornerstone on
December 31, 2007. Mr. Prices employment with
Cornerstone began on September 8, 2008. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Termination without Cause or
|
|
|
|
|
|
|
for Good Reason in Connection
|
|
|
|
|
|
|
with a Change in Control
|
|
Voluntary
|
|
|
|
|
|
|
|
|
Value of
|
|
Value of
|
|
Resignation
|
|
Death/Disability
|
|
|
|
|
|
|
Options with
|
|
Stock with
|
|
Following a Change
|
|
Following a Change
|
|
|
|
|
Value of
|
|
Accelerated
|
|
Accelerated
|
|
in Control
|
|
in Control
|
Name
|
|
Cash Payments
|
|
Benefits
|
|
Vesting
|
|
Vesting
|
|
Cash Payments
|
|
Cash Payments
|
|
Craig A. Collard
|
|
$
|
1,242,849
|
|
|
$
|
25,626
|
|
|
$
|
213,750
|
(1)(2)
|
|
|
|
|
|
$
|
147,849
|
|
|
$
|
147,849
|
|
Chenyqua Baldwin
|
|
$
|
53,750
|
|
|
$
|
2,016
|
|
|
$
|
160,313
|
(2)(3)
|
|
|
|
(4)
|
|
|
|
|
|
|
|
|
Brian Dickson, M.D.
|
|
$
|
65,000
|
|
|
$
|
3,204
|
|
|
$
|
170,469
|
(2)(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
George Esgro(5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven M. Lutz
|
|
$
|
102,000
|
|
|
$
|
6,138
|
|
|
$
|
165,001
|
(2)(3)
|
|
|
|
|
|
|
|
|
|
|
|
|
David Price(6)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Mr. Collards Executive Retention Agreement provides
that in the event that his employment is terminated within
24 months following a change in control either by
Cornerstone without cause, or by Mr. Collard for good
reason, any stock options then held by Mr. Collard will
also become immediately exercisable in full, and each
outstanding restricted stock award will become fully vested and
no longer subject to a right of repurchase by Cornerstone. |
|
(2) |
|
Reflects the fair value of the executive officers unvested
options at December 31, 2007. |
|
(3) |
|
The 2005 Equity Incentive Plan provides for accelerated vesting
of option awards under specified circumstances following a
change in control. For a more complete description of these
circumstances, |
324
|
|
|
|
|
please see the section Narrative Disclosure to Summary
Compensation Table and Grants of Plan-Based Awards Table
beginning on page 312 of this proxy statement/prospectus. |
|
(4) |
|
Cornerstone is a private company and no public market exists for
its common stock. |
|
(5) |
|
Mr. Esgro was not employed by Cornerstone on
December 31, 2007. Mr. Esgros employment with
Cornerstone began in March 2008. |
|
(6) |
|
Mr. Price was not employed by Cornerstone on
December 31, 2007. Mr. Prices employment with
Cornerstone began on September 8, 2008. |
Potential
Payments Upon Termination or Change of Control with Respect to
Mr. Townsend
The employment agreement between Critical Therapeutics and
Mr. Townsend provides for payments and benefits to
Mr. Townsend upon termination of employment or a change of
control of Critical Therapeutics under specified circumstances.
For information regarding the specific circumstances that would
trigger payments and the provision of benefits, the manner in
which payments and benefits would be provided and conditions
applicable to the receipt of payments and benefits, see the
section Narrative Disclosure to Summary Compensation Table
and Grants of Plan-Based Awards Table Employment and
Related Agreements with Mr. Townsend beginning on
page 314 of this proxy statement/prospectus.
The following tables set forth information regarding potential
payments and benefits Mr. Townsend would receive upon
termination of employment or a change of control of Critical
Therapeutics under specified circumstances, assuming that the
triggering event in question occurred on December 31, 2007,
the last business day of the fiscal year.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Termination without Cause or for Good Reason
|
|
|
|
|
|
|
|
|
Value of Stock with
|
|
Voluntary Resignation
|
Name
|
|
Cash Payments
|
|
Value of Benefits
|
|
Accelerated Vesting
|
|
Cash Payments
|
|
Scott B. Townsend, Esq.
|
|
$
|
318,500
|
(1)
|
|
$
|
16,432
|
(2)
|
|
$
|
24,333
|
(3)
|
|
$
|
69,000
|
(4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immediately
|
|
|
|
|
upon a Change
|
|
|
|
|
of Control
|
|
|
|
|
|
|
|
|
Value of Stock
|
|
|
|
|
|
|
|
|
with
|
|
Termination in Connection with a Change of Control
|
|
|
Accelerated
|
|
|
|
|
|
Value of Stock with
|
Name
|
|
Vesting
|
|
Cash Payments
|
|
Value of Benefits
|
|
Accelerated Vesting
|
|
Scott B. Townsend, Esq.
|
|
$
|
24,333
|
(3)
|
|
$
|
318,500
|
(1)
|
|
$
|
26,432
|
(5)
|
|
$
|
48,666
|
|
|
|
|
(1) |
|
Reflects (i) a lump sum payment equal to annual base salary
in effect on December 31, 2007 and (ii) a pro rata
payment of the target cash bonus for 2007 for Mr. Townsend. |
|
(2) |
|
Reflects 12 monthly payments in the amount of (i) 100%
of the monthly COBRA premiums for continued health and dental
coverage for Mr. Townsend and his dependents and
(ii) 100% of the amount of life insurance and disability
insurance for Mr. Townsend in the month prior to
termination for 12 months. |
|
(3) |
|
Calculated by multiplying the number of shares subject to
accelerated vesting by $1.27, the closing market price per share
of Critical Therapeutics common stock on December 31,
2007. |
|
(4) |
|
Reflects a lump sum pro rata payment of the actual annual cash
bonus paid to Mr. Townsend in the previous year. |
|
(5) |
|
Reflects 12 monthly payments in the amount of (i) 100%
of the monthly COBRA premiums for continued health and dental
coverage for Mr. Townsend and his dependents and
(ii) 100% of the amount of life insurance and disability
insurance for Mr. Townsend in the month prior to
termination for 12 months. In addition, this includes
$10,000 which is Critical Therapeutics estimate of the
fair market value of the up to three months of outplacement
services that would be provided to Mr. Townsend if Critical
Therapeutics terminates his employment other than for
cause or if he terminates his employment for
good reason during the change of control
period. |
325
2007 Director
Compensation
In 2007, Cornerstone used cash compensation and option awards to
attract and retain qualified candidates to serve on its board of
directors. In setting director compensation, Cornerstone
considered the significant amount of time directors expend in
fulfilling their duties to the company as well as the skill
level required. In connection with his service as a director in
2007, Mr. McEwan received $60,000 in cash compensation and
an option award of 500,000 shares of common stock.
The policy of the combined company with respect to the
compensation of directors is expected to be determined at the
first meeting of the board of directors following the
consummation of the merger.
The table below summarizes the compensation paid by Cornerstone
to its directors for the fiscal year ended December 31,
2007.
DIRECTOR
COMPENSATION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fees Earned
|
|
|
|
Non-Equity
|
|
|
|
|
|
|
or Paid
|
|
Option
|
|
Incentive Plan
|
|
All Other
|
|
|
|
|
in Cash
|
|
Awards
|
|
Compensation
|
|
Compensation
|
|
Total
|
Name (1)
|
|
($)
|
|
($)
|
|
($)
|
|
($)
|
|
($)
|
|
Alastair McEwan
|
|
|
60,000
|
|
|
|
48,982
|
(2)
|
|
|
|
|
|
|
42,813
|
(3)
|
|
|
151,795
|
|
|
|
|
(1) |
|
Craig A. Collard, Cornerstones President and Chief
Executive Officer, is a director but receives no additional
compensation for his services as a director. The compensation
received by Mr. Collard as a Cornerstone employee is shown
in the section Summary Compensation Table beginning
on page 310 of this proxy statement/prospectus. |
|
(2) |
|
The grant date fair value of this award was $135,000. At
December 31, 2007, the aggregate number of option awards
held by Mr. McEwan was 1,500,000. |
|
(3) |
|
In addition to compensation for his service as a director, in
2007 Mr. McEwan received $30,000 in cash compensation and
$12,813 in certain benefits as an employee of Cornerstone. For a
more complete description of Mr. McEwans employment
arrangement, please see the section Certain Relationships
and Related Transactions, and Director Independence
Employment Arrangement with Mr. McEwan beginning on
page 299 of this proxy
statement/prospectus. |
Compensation
Committee Interlocks and Insider Participation
The combined companys Compensation Committee of the board
of directors will consist of Mr. Heffernan and
Mr. Enright. Mr. Heffernan will be the chairman of the
compensation committee. No member of the Compensation Committee
will have been at any time an officer or employee of
Cornerstone. None of the combined companys executive
officers serves, or in the past year has served, as a member of
the board of directors or compensation committee of any entity
that has one or more executive officers serving on the
compensation committee of either Critical Therapeutics or
Cornerstone. None of the combined companys executive
officers serves, or in the past year has served, as a member of
the compensation committee of any entity that has one or more
executive officers serving on Cornerstones board of
directors.
326
UNAUDITED
PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION
The following unaudited pro forma condensed combined financial
statements give effect to the merger of a wholly owned
subsidiary of Critical Therapeutics and Cornerstone in a
transaction to be accounted for as a purchase with Cornerstone
treated as the acquirer even though Critical Therapeutics will
be the issuer of common stock and surviving legal entity in the
transaction (based in part on the fact that upon completion of
the merger Critical Therapeutics stockholders will retain
approximately 30% and the former Cornerstone stockholders will
own approximately 70% of the outstanding shares of Critical
Therapeutics, assuming the exchange or conversion prior to the
merger of the outstanding principal amount of the Carolina Note
into shares of Cornerstones common stock and after giving
effect to shares issuable pursuant to Cornerstones
outstanding options and warrants, but without giving effect to
any shares issuable pursuant to Critical Therapeutics
outstanding options and warrants). The unaudited pro forma
condensed balance sheet combines the historical consolidated
balance sheets of Critical Therapeutics and Cornerstone as of
June 30, 2008, giving effect to the combination as if it
occurred on June 30, 2008, reflecting only pro forma
adjustments expected to have a continuing impact on the combined
results. The unaudited pro forma condensed statements of
operations are based on the individual historical consolidated
statements of operations of Critical Therapeutics and
Cornerstone and combine the results of operations of Critical
Therapeutics and Cornerstone for the year ended
December 31, 2007 and the six months ended June 30,
2008, giving effect to the combination as if it occurred on
January 1, 2007, reflecting only pro forma adjustments
expected to have a continuing impact on the combined results.
The unaudited pro forma condensed combined financial information
does not give effect to the proposed reverse stock split as it
is currently unknown which ratio, if any, will be used.
These unaudited pro forma condensed combined financial
statements are for informational purposes only. They do not
purport to indicate the results that would have actually been
obtained had the merger been completed on the assumed date or
for the periods presented, or that may be realized in the
future. To produce the unaudited pro forma financial
information, Cornerstone, as the acquiring party, preliminarily
allocated the purchase price using its best estimates of fair
value. These estimates are based on the most recently available
information. To the extent there are significant changes to
Critical Therapeutics business, the assumptions and
estimates herein could change significantly. Furthermore, the
parties may have reorganization and restructuring expenses as
well as potential operating efficiencies as a result of
combining the companies. The pro forma financial information
does not reflect these potential expenses and efficiencies. Upon
completion of the merger, final valuations will be performed.
The unaudited pro forma condensed combined financial statements
should be read in conjunction with Critical
Therapeutics Managements Discussion and Analysis of
Financial Condition and Results of Operations and
Cornerstones Managements Discussion and
Analysis of Financial Condition and Results of Operations
and the historical consolidated financial statements, including
related notes of Critical Therapeutics and Cornerstone,
respectively, covering these periods, included in this proxy
statement/prospectus or incorporated herein by reference. Please
see the section entitled Where You Can Find More
Information on page 352 of this proxy
statement/prospectus for more information.
327
UNAUDITED
PRO FORMA CONDENSED COMBINED BALANCE SHEET
As of June 30, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
Critical
|
|
|
|
|
|
Pro Forma
|
|
|
See
|
|
|
Pro Forma
|
|
|
|
Therapeutics
|
|
|
Cornerstone
|
|
|
Adjustments
|
|
|
Note 3
|
|
|
Combined
|
|
|
|
(Amounts in thousands)
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
10,952
|
|
|
$
|
19
|
|
|
$
|
(1,951
|
)
|
|
|
H
|
|
|
$
|
9,020
|
|
Accounts receivable, net
|
|
|
1,520
|
|
|
|
10,300
|
|
|
|
|
|
|
|
|
|
|
|
11,820
|
|
Amounts due from related parties
|
|
|
|
|
|
|
713
|
|
|
|
|
|
|
|
|
|
|
|
713
|
|
Inventory
|
|
|
7,760
|
|
|
|
3,659
|
|
|
|
242
|
|
|
|
K
|
|
|
|
11,661
|
|
Prepaid expenses and other
|
|
|
2,490
|
|
|
|
517
|
|
|
|
|
|
|
|
|
|
|
|
3,007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
22,722
|
|
|
|
15,208
|
|
|
|
(1,709
|
)
|
|
|
|
|
|
|
36,221
|
|
Fixed assets, net
|
|
|
352
|
|
|
|
187
|
|
|
|
|
|
|
|
|
|
|
|
539
|
|
Intangible assets
|
|
|
|
|
|
|
|
|
|
|
10,000
|
|
|
|
B
|
|
|
|
10,000
|
|
Amounts due from related parties
|
|
|
|
|
|
|
38
|
|
|
|
|
|
|
|
|
|
|
|
38
|
|
Other assets
|
|
|
284
|
|
|
|
5,888
|
|
|
|
|
|
|
|
|
|
|
|
6,172
|
|
Goodwill
|
|
|
|
|
|
|
|
|
|
|
1,711
|
|
|
|
G
|
|
|
|
1,711
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
23,358
|
|
|
$
|
21,321
|
|
|
$
|
10,002
|
|
|
|
|
|
|
$
|
54,681
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Line of credit
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
Current portion of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued license fees
|
|
|
1,796
|
|
|
|
576
|
|
|
|
|
|
|
|
|
|
|
|
2,372
|
|
Deferred co-promotion fees
|
|
|
1,880
|
|
|
|
|
|
|
$
|
(1,880
|
)
|
|
|
E
|
|
|
|
|
|
Accounts payable
|
|
|
4,311
|
|
|
|
3,276
|
|
|
|
|
|
|
|
|
|
|
|
7,587
|
|
Accrued expenses
|
|
|
5,325
|
|
|
|
13,944
|
|
|
|
1,500
|
|
|
|
D
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,951
|
)
|
|
|
H
|
|
|
|
18,818
|
|
Income taxes payable
|
|
|
|
|
|
|
916
|
|
|
|
|
|
|
|
|
|
|
|
916
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
13,312
|
|
|
|
18,712
|
|
|
|
(2,331
|
)
|
|
|
|
|
|
|
29,693
|
|
Long-term portion of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued license fees
|
|
|
|
|
|
|
2,959
|
|
|
|
|
|
|
|
|
|
|
|
2,959
|
|
Deferred co-promotion fees
|
|
|
8,870
|
|
|
|
|
|
|
|
(8,870
|
)
|
|
|
E
|
|
|
|
|
|
Note payable, related party
|
|
|
|
|
|
|
8,952
|
|
|
|
(8,952
|
)
|
|
|
H
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
22,182
|
|
|
|
30,623
|
|
|
|
(20,153
|
)
|
|
|
|
|
|
|
32,652
|
|
Stockholders equity (deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
43
|
|
|
|
2
|
|
|
|
142
|
|
|
|
A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(43
|
)
|
|
|
F
|
|
|
|
144
|
|
Additional paid-in capital
|
|
|
209,919
|
|
|
|
970
|
|
|
|
23,337
|
|
|
|
A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(209,919
|
)
|
|
|
F
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,952
|
|
|
|
H
|
|
|
|
33,259
|
|
Accumulated deficit
|
|
|
(208,770
|
)
|
|
|
(10,274
|
)
|
|
|
208,770
|
|
|
|
F
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,100
|
)
|
|
|
C
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,374
|
)
|
Accumulated other comprehensive loss
|
|
|
(16
|
)
|
|
|
|
|
|
|
16
|
|
|
|
F
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity (deficit)
|
|
|
1,176
|
|
|
|
(9,302
|
)
|
|
|
30,155
|
|
|
|
|
|
|
|
22,029
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity (deficit)
|
|
$
|
23,358
|
|
|
$
|
21,321
|
|
|
$
|
10,002
|
|
|
|
|
|
|
$
|
54,681
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Amounts derived from the unaudited condensed consolidated
financial statements of Critical Therapeutics beginning on
page F-36 of this proxy statement/prospectus and from the
unaudited consolidated financial statements of Cornerstone
beginning on
page F-88
of this proxy statement/prospectus. |
328
UNAUDITED
PRO FORMA CONDENSED COMBINED
STATEMENT OF OPERATIONS
YEAR ENDED DECEMBER 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
Critical
|
|
|
|
|
|
Pro Forma
|
|
|
See
|
|
|
Pro Forma
|
|
|
|
Therapeutics
|
|
|
Cornerstone
|
|
|
Adjustments
|
|
|
Note 3
|
|
|
Combined
|
|
|
|
(Amounts in thousands, except share and per share data)
|
|
|
Net revenues
|
|
$
|
12,869
|
|
|
$
|
28,071
|
|
|
|
|
|
|
|
|
|
|
$
|
40,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
4,233
|
|
|
|
6,709
|
|
|
|
|
|
|
|
|
|
|
|
10,942
|
|
Research and development
|
|
|
21,655
|
|
|
|
948
|
|
|
|
|
|
|
|
|
|
|
|
22,603
|
|
Sales, general and administrative
|
|
|
25,765
|
|
|
|
17,973
|
|
|
$
|
1,413
|
|
|
|
I
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
567
|
|
|
|
E
|
|
|
|
45,718
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
51,653
|
|
|
|
25,630
|
|
|
|
1,980
|
|
|
|
|
|
|
|
79,263
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income
|
|
|
(38,784
|
)
|
|
|
2,441
|
|
|
|
(1,980
|
)
|
|
|
|
|
|
|
(38,323
|
)
|
Other income (expense)
|
|
|
1,811
|
|
|
|
(1,741
|
)
|
|
|
|
|
|
|
|
|
|
|
70
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before income taxes
|
|
|
(36,973
|
)
|
|
|
700
|
|
|
|
(1,980
|
)
|
|
|
|
|
|
|
(38,253
|
)
|
Provision for income taxes
|
|
|
|
|
|
|
130
|
|
|
|
|
|
|
|
J
|
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(36,973
|
)
|
|
$
|
570
|
|
|
$
|
(1,980
|
)
|
|
|
|
|
|
$
|
(38,383
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
$
|
(0.87
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(0.34
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding(2)(3)
|
|
|
42,580,884
|
|
|
|
24,926,150
|
|
|
|
45,009,125
|
|
|
|
L
|
|
|
|
112,516,159
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Amounts derived from the audited consolidated financial
statements of Critical Therapeutics beginning on page F-3
of this proxy statement/prospectus and from the audited
consolidated financial statements of Cornerstone beginning on
page F-54
of this proxy statement/prospectus. |
|
(2) |
|
Common stock equivalents are not considered in this calculation
because they are antidilutive to the combined earnings per share. |
|
(3) |
|
See Note 3 for a discussion of the impact of the proposed
reverse stock split on weighted-average common shares
outstanding and the related effect on net loss per share. |
329
UNAUDITED
PRO FORMA CONDENSED COMBINED
STATEMENT OF OPERATIONS
SIX MONTHS ENDED JUNE 30, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
Critical
|
|
|
|
|
|
Pro Forma
|
|
|
See
|
|
|
Pro Forma
|
|
|
|
Therapeutics
|
|
|
Cornerstone
|
|
|
Adjustments
|
|
|
Note 3
|
|
|
Combined
|
|
|
|
(Amounts in thousands, except share and per share data)
|
|
|
Net revenues
|
|
$
|
7,227
|
|
|
$
|
23,512
|
|
|
|
|
|
|
|
|
|
|
$
|
30,739
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
4,657
|
|
|
|
6,302
|
|
|
|
|
|
|
|
|
|
|
|
10,959
|
|
Research and development
|
|
|
6,927
|
|
|
|
605
|
|
|
|
|
|
|
|
|
|
|
|
7,532
|
|
Sales, general and administrative
|
|
|
12,041
|
|
|
|
12,220
|
|
|
$
|
769
|
|
|
|
I
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
683
|
|
|
|
E
|
|
|
|
25,713
|
|
Restructuring charges
|
|
|
1,204
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,204
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
24,829
|
|
|
|
19,127
|
|
|
|
1,452
|
|
|
|
|
|
|
|
45,408
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income
|
|
|
(17,602
|
)
|
|
|
4,385
|
|
|
|
(1,452
|
)
|
|
|
|
|
|
|
(14,669
|
)
|
Other income (expense)
|
|
|
204
|
|
|
|
(722
|
)
|
|
|
|
|
|
|
|
|
|
|
(518
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before income taxes
|
|
|
(17,398
|
)
|
|
|
3,663
|
|
|
|
(1,452
|
)
|
|
|
|
|
|
|
(15,187
|
)
|
Provision for income taxes
|
|
|
|
|
|
|
839
|
|
|
|
|
|
|
|
J
|
|
|
|
839
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(17,398
|
)
|
|
$
|
2,824
|
|
|
$
|
(1,452
|
)
|
|
|
|
|
|
$
|
(16,026
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
$
|
(0.41
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(0.13
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding(2)(3)
|
|
|
42,857,558
|
|
|
|
30,825,777
|
|
|
|
47,824,960
|
|
|
|
L
|
|
|
|
121,508,295
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Amounts derived from the unaudited consolidated financial
statements of Critical Therapeutics beginning on page F-36
of this proxy statement/prospectus and from the unaudited
consolidated financial statements of Cornerstone beginning on
page F-88
of this proxy statement/prospectus. |
|
(2) |
|
Common stock equivalents not considered in this calculation
because they are antidilutive to the combined earnings per share. |
|
(3) |
|
See Note 3 for a discussion of the impact of the proposed
reverse stock split on weighted-average common shares
outstanding and the related effect on net loss per share. |
330
NOTES TO
UNAUDITED PRO FORMA CONDENSED
COMBINED FINANCIAL STATEMENTS
|
|
(1)
|
Description
of Transaction and Basis of Presentation
|
On May 1, 2008, Critical Therapeutics, Cornerstone and a
wholly owned subsidiary of Critical Therapeutics, Neptune
Acquisition Corp., entered into a merger agreement, which
provides that Neptune Acquisition Corp. will merge with and into
Cornerstone. This transaction will be accounted for under the
purchase method of accounting. Under the purchase method of
accounting, the assets and liabilities of Critical Therapeutics,
including a total of $305,000 in cash bonuses payable to certain
executives of Critical Therapeutics following the completion of
the merger, will be recorded as of the acquisition date, at
their respective fair values, and consolidated with those of
Cornerstone. The reported consolidated financial condition and
results of operations after completion of the merger will
reflect these fair values. The purchase price, including the
acquiring companys merger-related fees, is expected to be
approximately $24,979,000.
Under the terms of the merger agreement, each share of
Cornerstones common stock will be converted into and
exchanged for the right to receive the number of shares of
Critical Therapeutics common stock equal to the product of
2.3333 multiplied by the quotient of 43,479,198, which was the
number of outstanding shares of Critical Therapeutics
common stock on April 30, 2008, divided by the number of
shares of Cornerstones common stock outstanding
immediately prior to the effective time of the merger, assuming
the exercise or conversion of all outstanding Cornerstone stock
options and warrants, subject to adjustment for the reverse
stock split of Critical Therapeutics common stock. Each
restricted stock unit and outstanding option, whether vested or
unvested, and all outstanding warrants to purchase
Cornerstones common stock will be assumed by Critical
Therapeutics and become options and warrants to purchase
Critical Therapeutics common stock. All stock option plans
or other stock or equity-related plans of Cornerstone and
warrants to purchase Cornerstones common stock shall be
assumed by Critical Therapeutics on the same terms and
conditions as were applicable under Cornerstones plans
immediately prior to the effective time of merger.
Cornerstones stockholders will not receive any fractional
shares of Critical Therapeutics common stock in the
merger. Instead, any stockholder who would otherwise be entitled
to a fractional share of Critical Therapeutics common
stock will be entitled to receive an amount of cash, without
interest, equal to the product of such fraction multiplied by
the average last reported sales price for Critical
Therapeutics common stock during the ten trading days
preceding the effective time of the merger.
The unaudited pro forma condensed combined balance sheet and
condensed combined statements of operations for all periods
presented assume that the Carolina Note was converted into
5,899,627 shares of Cornerstone common stock at immediately
prior to the effective time of the merger.
The transaction is expected to qualify as a reorganization
within the meaning of Section 368(a) of the Internal
Revenue Code.
The merger is subject to customary closing conditions, including
the approval of the merger by Critical Therapeutics and
Cornerstones stockholders and regulatory approvals.
A preliminary estimate of the purchase price is as follows
(amounts in thousands):
|
|
|
|
|
Estimated fair value of Critical Therapeutics shares outstanding
|
|
$
|
23,479
|
|
Estimated acquiring company transaction costs incurred
|
|
|
1,500
|
|
|
|
|
|
|
Estimated purchase price
|
|
$
|
24,979
|
|
|
|
|
|
|
In accordance with SFAS 141, the fair value of Critical
Therapeutics common stock used in determining the purchase
price was $0.54 per share based on the average of the
closing prices for a range of trading days (April 29, 2008
through May 6, 2008, inclusive) around and including the
announcement date of the transaction.
331
NOTES TO
UNAUDITED PRO FORMA CONDENSED
COMBINED FINANCIAL
STATEMENTS (Continued)
For purposes of this pro forma analysis, the estimated purchase
price has been allocated based on a preliminary estimate of the
fair value of the assets acquired and liabilities assumed as of
June 30, 2008 (amounts in thousands):
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
10,952
|
|
Accounts receivable
|
|
|
1,520
|
|
Inventory
|
|
|
8,002
|
|
Prepaid expenses and other current assets
|
|
|
2,490
|
|
Fixed assets
|
|
|
352
|
|
Other assets
|
|
|
284
|
|
Intangible assets:
|
|
|
|
|
Product rights
|
|
|
10,000
|
|
Acquired in-process research and development
|
|
|
1,100
|
|
Goodwill
|
|
|
1,711
|
|
Assumed liabilities
|
|
|
(11,432
|
)
|
|
|
|
|
|
Total
|
|
$
|
24,979
|
|
|
|
|
|
|
The purchase price allocation will remain preliminary until
Cornerstone completes a final valuation of the assets acquired
and liabilities assumed as of the date that the merger is
consummated. The final amounts allocated to assets and
liabilities acquired could differ significantly from the amounts
presented in the unaudited pro forma condensed combined
financial statements.
The amount allocated to acquired inventory has been attributed
to the following categories (amounts in thousands):
|
|
|
|
|
Raw materials
|
|
$
|
6,163
|
|
Work in process
|
|
|
1,741
|
|
Finished goods
|
|
|
98
|
|
|
|
|
|
|
Total
|
|
$
|
8,002
|
|
|
|
|
|
|
In accordance with SFAS 141, the estimated fair value of
raw materials was determined based on their replacement cost.
The estimated fair value of work in process and finished goods
were determined by estimating the selling prices of those goods
less the costs of disposal, a reasonable profit allowance and,
with respect to work in process, the costs of completion.
The amount allocated to acquired identifiable intangible assets
has been attributed to the following categories (amounts in
thousands):
|
|
|
|
|
ZYFLO CR Product Rights
|
|
$
|
10,000
|
|
alpha-7 program
|
|
|
1,100
|
|
|
|
|
|
|
Total
|
|
$
|
11,100
|
|
|
|
|
|
|
The estimated fair value attributed to the ZYFLO CR Product
Rights was determined based on a discounted forecast of the
estimated net future cash flows to be generated from the ZYFLO
CR Product Rights. The estimated fair value attributed to the
ZYFLO CR Product Rights is estimated to have a 6.5 year useful
life from the expected closing date of the merger. In the six
months ended June 30, 2008, Critical Therapeutics
experienced supply chain issues in manufacturing ZYFLO CR and
recorded an inventory reserve for an aggregate of 12 batches of
ZYFLO CR that could not be released into Critical
Therapeutics supply chain. In conjunction with Critical
Therapeutics three third-party manufacturers for zileuton
API, tablet cores and
332
NOTES TO
UNAUDITED PRO FORMA CONDENSED
COMBINED FINANCIAL
STATEMENTS (Continued)
coating and release, Critical Therapeutics has initiated an
investigation to determine the cause of this issue, but the
investigation is ongoing and is not yet complete. To date, the
investigation has not identified a clear source of the issue. In
August and September 2008, Critical Therapeutics released and
made available for shipment to wholesale distributors an
aggregate of six batches of finished ZYFLO CR tablets that met
its product release specifications. Critical Therapeutics is
currently unable to accurately assess the timing and quantity of
future batches of ZYFLO CR, if any, that may be released for
commercial supply. If not corrected, the ongoing supply chain
difficulties could prevent Critical Therapeutics from supplying
any further product to its wholesale distributors. Based on its
current level of sales and the release of the six batches of
ZYFLO CR in August and September 2008, Critical Therapeutics
estimates that wholesale distributors and retail pharmacies will
have a sufficient inventory of ZYFLO CR to continue to provide
product to patients through the fourth quarter of 2008. The
potential future financial impact of supply chain issues in
manufacturing ZYFLO CR is not reasonably capable of being
estimated. Accordingly, the fair value determination for the
ZYFLO CR Product Rights and the pro forma adjustments described
in Note 3 below assume that ZYFLO CR will continue to be
available for commercial supply.
The amount allocated to in-process research and development for
the alpha-7 program represents an estimate of the fair value of
purchased in-process technology for this research program that,
as of the expected closing date of the merger, will not have
reached technological feasibility and have no alternative future
use. The alpha-7 program is the only Critical Therapeutics
research program that had advanced to a stage of development
where management believed reasonable net future cash flow
forecasts could be prepared and a reasonable likelihood of
technical success existed.
The estimated fair value of the alpha-7 program was determined
based on a discounted forecast of the estimated net future
royalties from the anticipated out-licensing of the alpha-7
program considering the estimated probability of technical
success and FDA approval. In-process research and development
will be expensed immediately following consummation of the
merger.
|
|
(3)
|
Pro
Forma Adjustments
|
|
|
A. |
To record the fair value of Critical Therapeutics
outstanding common stock assumed in connection with the merger.
Cash paid in lieu of fractional shares will be from existing
cash balances and has not been reflected.
|
|
|
B.
|
To record the estimated fair value of an acquired identifiable
intangible asset (ZYFLO CR Product Rights) arising from the
merger.
|
|
C.
|
To record the estimated fair value of in-process research and
development acquired in the merger. Because this expense is
directly attributable to the acquisition and will not have a
continuing impact, it is not reflected in the pro forma
condensed combined statements of operations. However, this item
will be recorded as an expense immediately following
consummation of the merger.
|
|
|
D. |
To record estimated Cornerstone transaction costs of
$1.5 million; transaction costs incurred by Critical
Therapeutics will be expensed as incurred. These amounts are not
reflected in the pro forma statements of operations.
|
|
|
E. |
To eliminate deferred co-promotion fees for ZYFLO and ZYFLO CR
as Critical Therapeutics has no performance obligations or
continuing obligations to incur any significant costs in
connection with this agreement after the effective time of the
merger.
|
|
|
F. |
To eliminate and adjust the historical equity accounts of
Critical Therapeutics.
|
|
|
G. |
To record goodwill arising from the excess of the purchase price
over the fair value of the acquired net assets.
|
333
NOTES TO
UNAUDITED PRO FORMA CONDENSED
COMBINED FINANCIAL
STATEMENTS (Continued)
|
|
H. |
To reflect the issuance of common stock and payment in cash of
interest due in settlement of the Carolina Note.
|
|
|
I.
|
To record the amortization of the excess purchase price
allocated to an identifiable intangible asset (ZYFLO CR Product
Rights) of $10.0 million over an estimated life of
6.5 years.
|
|
J.
|
The tax effect of the pro forma adjustments was calculated at
the statutory rate and was determined to be zero because of the
availability of net operating loss (NOL) and R&D credit
carryforwards. Utilization of the NOL and R&D credit
carryforwards may be subject to a substantial annual limitation
due to ownership change limitations provided by Section 382
of the Internal Revenue Code of 1986, as well as similar state
provisions. It is expected that the combined company will
continue to provide a full valuation allowance on its deferred
tax assets.
|
|
|
K. |
To record the estimated fair value of raw materials, work in
process and finished goods arising from the merger. These
amounts are not reflected in the pro forma statements of
operations.
|
|
|
L. |
To reflect the weighted-average shares outstanding as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2007
|
|
|
|
Critical
|
|
|
|
|
|
Pro Forma
|
|
|
|
|
|
|
Therapeutics
|
|
|
Cornerstone
|
|
|
Adjustments
|
|
|
Total
|
|
|
Weighted-average basic and diluted shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preliminary shares outstanding
|
|
|
42,580,884
|
|
|
|
24,926,150
|
|
|
|
|
|
|
|
67,507,034
|
|
Number of shares common stock issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange ratio
|
|
|
|
|
|
|
2.805699
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued to Cornerstone stockholders, net
|
|
|
|
|
|
|
69,935,275
|
|
|
|
|
|
|
|
69,935,275
|
|
Pro forma adjustment
|
|
|
69,935,275
|
|
|
|
(69,935,275
|
)
|
|
|
(24,926,150
|
)
|
|
|
(24,926,150
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shares outstanding, post exchange
|
|
|
112,516,159
|
|
|
|
|
|
|
|
|
|
|
|
112,516,159
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2008
|
|
|
|
Critical
|
|
|
|
|
|
Pro Forma
|
|
|
|
|
|
|
Therapeutics
|
|
|
Cornerstone
|
|
|
Adjustments
|
|
|
Total
|
|
|
Weighted-average basic and diluted shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preliminary shares outstanding
|
|
|
42,857,558
|
|
|
|
24,926,150
|
|
|
|
|
|
|
|
67,783,708
|
|
Conversion of the Carolina Note
|
|
|
|
|
|
|
5,899,627
|
|
|
|
|
|
|
|
5,899,627
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,857,558
|
|
|
|
30,825,777
|
|
|
|
|
|
|
|
73,683,335
|
|
Number of shares common stock issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange ratio
|
|
|
|
|
|
|
2.551460
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued to Cornerstone stockholders, net
|
|
|
|
|
|
|
78,650,737
|
|
|
|
|
|
|
|
78,650,737
|
|
Pro forma adjustment
|
|
|
78,650,737
|
|
|
|
(78,650,737
|
)
|
|
|
(30,825,777
|
)
|
|
|
(30,825,777
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shares outstanding, post exchange
|
|
|
121,508,295
|
|
|
|
|
|
|
|
|
|
|
|
121,508,295
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
334
NOTES TO
UNAUDITED PRO FORMA CONDENSED
COMBINED FINANCIAL
STATEMENTS (Continued)
Reverse
Stock Split
Critical Therapeutics stockholders also are being asked to
approve an amendment to Critical Therapeutics certificate
of incorporation to effect a reverse stock split of the issued
and outstanding shares of Critical Therapeutics common
stock. Upon the effectiveness of the amendment to Critical
Therapeutics certificate of incorporation effecting the
reverse stock split, the outstanding shares of Critical
Therapeutics common stock will be reclassified and
combined into a lesser number of shares such that one share of
Critical Therapeutics common stock will be issued for a
specified number of shares, which shall be greater than one and
equal to or less than 50, of outstanding Critical
Therapeutics common stock, with the exact number within
the range to be determined by Critical Therapeutics board
of directors prior to the effective time of the amendment and
publicly announced by Critical Therapeutics. If the stockholders
approve the proposal to implement the reverse stock split, the
reverse stock split would become effective immediately prior to
the effective time of the merger. The reverse stock split will
be effected simultaneously for all outstanding shares of
Critical Therapeutics common stock. The reverse stock
split will affect all of Critical Therapeutics
stockholders uniformly and will not affect any
stockholders percentage ownership interests in Critical
Therapeutics, except to the extent that the reverse stock split
results in any of Critical Therapeutics stockholders
owning a fractional share. The reverse stock split will not
change the number of authorized shares, or the par value, of
Critical Therapeutics common stock. As of the effective
time of the reverse stock split, Critical Therapeutics will
adjust and proportionately decrease the number of shares of
Critical Therapeutics common stock reserved for issuance
upon exercise of, and adjust and proportionately increase the
exercise price of, all options and warrants and other rights to
acquire Critical Therapeutics common stock.
Assuming reverse stock split ratios of
one-for-fifty
and
one-for-two,
which are ratios based on whole numbers of shares at the high
end and low end of the range that Critical Therapeutics
stockholders are being asked to approve, the following table
sets forth estimates of the pro forma combined net loss per
share and weighted-average common shares outstanding for the
year ended December 31, 2007 and the six months ended
June 30, 2008, giving effect to the reverse stock split as
if it occurred on January 1, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reverse Stock Split Ratio of One-for-Fifty
|
|
Reverse Stock Split Ratio of One-for-Two
|
|
|
Year Ended
|
|
Six Months Ended
|
|
Year Ended
|
|
Six Months Ended
|
|
|
December 31, 2007
|
|
June 30, 2008
|
|
December 31, 2007
|
|
June 30, 2008
|
Net loss per share
|
|
$
|
(17.06
|
)
|
|
$
|
(6.60
|
)
|
|
$
|
(0.68
|
)
|
|
$
|
(0.26
|
)
|
Weighted-average common shares outstanding
|
|
|
2,250,323
|
|
|
|
2,430,166
|
|
|
|
56,258,080
|
|
|
|
60,754,148
|
|
The amounts in the table above do not give effect to any
potential impact of fractional shares.
335
DESCRIPTION
OF CRITICAL THERAPEUTICS CAPITAL STOCK
The following description of Critical Therapeutics capital
stock summarizes the material terms and provisions of the
capital stock. For the complete terms of Critical
Therapeutics capital stock, please refer to Critical
Therapeutics certificate of incorporation and bylaws. The
terms of Critical Therapeutics capital stock may also be
affected by Delaware law.
Authorized
Capital Stock
Critical Therapeutics authorized capital stock consists of
90,000,000 shares of common stock, $0.001 par value
per share, and 5,000,000 shares of preferred stock,
$0.001 par value per share. As of September 29, 2008,
there were 43,332,598 shares of common stock outstanding
and no shares of preferred stock outstanding. Upon the
consummation of the merger, without giving effect to the reverse
stock split, there will be approximately
125.3 million shares of Critical Therapeutics
common stock outstanding. Approximately
81.9 million shares of Critical Therapeutics
common stock will be issued to Cornerstones common
stockholders in connection with the merger, based on shares of
Cornerstones common stock outstanding as of
September 29, 2008, the last practicable date before the
printing of this proxy statement/prospectus. Each outstanding
option to purchase shares of Cornerstone common stock, whether
vested or unvested, and all stock option plans or other stock or
equity-related plans of Cornerstone themselves, insofar as they
relate to outstanding Cornerstone stock options, will be assumed
by Critical Therapeutics and will become an option to acquire,
on the same terms and conditions as were applicable under such
Cornerstone stock option immediately prior to the effective time
of the merger, such number of shares of Critical
Therapeutics common stock as is equal to the number of
shares of Cornerstones common stock subject to the
unexercised portion of such Cornerstone stock option immediately
prior to the effective time of the merger multiplied by the
exchange ratio (rounded down to the nearest whole share number),
at an exercise price per share equal to the exercise price per
share of such Cornerstone stock option immediately prior to the
effective time of the merger divided by the exchange ratio
(rounded up to the nearest whole cent). Each warrant to purchase
shares of Cornerstone common stock outstanding immediately prior
to the effective time of the merger shall be assumed by Critical
Therapeutics and will become a warrant to acquire, on the same
terms and conditions as were applicable under such warrant, such
number of shares of Critical Therapeutics common stock as
is equal to the number of shares of Cornerstones common
stock subject to the unexercised portion of such Cornerstone
warrant immediately prior to the effective time of the merger
multiplied by the exchange ratio (rounded down to the nearest
whole share number), at an exercise price per share equal to the
exercise price per share of such Cornerstone warrant immediately
prior to the effective time of the merger divided by the
exchange ratio (rounded up to the nearest whole cent).
Common
Stock
Voting
For all matters submitted to a vote of stockholders, each holder
of common stock is entitled to one vote for each share
registered in the stockholders name. Critical
Therapeutics common stock does not have cumulative voting
rights. Accordingly, holders of a majority of the shares of
common stock entitled to vote in any election of directors may
elect all of the directors standing for election. An election of
directors by Critical Therapeutics stockholders is
determined by a plurality of the votes cast by the stockholders
entitled to vote in the election.
Dividends
Holders of common stock are entitled to share ratably in any
dividends declared by Critical Therapeutics board of
directors, subject to any preferential dividend rights of any
outstanding preferred stock. Dividends consisting of shares of
common stock may be paid to holders of shares of common stock.
Critical Therapeutics has never declared or paid cash dividends
on Critical Therapeutics capital stock. Critical
Therapeutics does not intend to pay cash dividends in the
foreseeable future.
336
Liquidation
and Dissolution
If Critical Therapeutics is liquidated or dissolved, the holders
of its common stock will be entitled to share ratably in all the
assets that remain after Critical Therapeutics pays its
liabilities, subject to the prior rights of any outstanding
preferred stock.
Other
Rights and Restrictions
Holders of Critical Therapeutics common stock do not have
preemptive rights, and they have no right to convert their
common stock into any other securities. Critical
Therapeutics common stock is not subject to redemption.
Critical Therapeutics certificate of incorporation and
bylaws do not restrict the ability of a holder of common stock
to transfer the stockholders shares of common stock. When
Critical Therapeutics issues shares of common stock under this
prospectus, the shares will be fully paid and non-assessable and
will not have, or be subject to, any preemptive or similar
rights.
Listing
Critical Therapeutics common stock is listed on The NASDAQ
Capital Market under the symbol CRTX. On
September 15, 2008, the last reported sale price for
Critical Therapeutics common stock on The NASDAQ Capital
Market was $0.22 per share. As of September 15, 2008
Critical Therapeutics had approximately 76 stockholders of
record.
Transfer
Agent and Registrar
The transfer agent and registrar for Critical Therapeutics
common stock is BNY Mellon Shareowner Services.
Preferred
Stock
Critical Therapeutics board of directors is authorized,
subject to any limitations under its certificate of
incorporation or prescribed by law, without further stockholder
approval, to issue up to an aggregate of 5,000,000 shares
of preferred stock. Critical Therapeutics board of
directors may establish the applicable and relative
designations, number of authorized shares, dividend rates and
terms, redemption or sinking fund provisions, conversion or
exchange rates, anti-dilution provisions, voting rights,
liquidation preferences and other terms, preferences and
limitations of any series of preferred stock it determines to
issue.
Delaware
Law and Certificate of Incorporation and Bylaw
Provisions
Anti-Takeover
Provisions
Critical Therapeutics is subject to Section 203 of the
Delaware General Corporation Law. Subject to certain exceptions,
Section 203 prevents a publicly held Delaware corporation
from engaging in a business combination with any
interested stockholder for three years following the
date that the person became an interested stockholder, unless
the interested stockholder attained such status with the
approval of Critical Therapeutics board of directors or
unless the business combination is approved in a prescribed
manner. A business combination includes, among other
things, a merger or consolidation involving Critical
Therapeutics and the interested stockholder and the
sale of more than 10% of Critical Therapeutics assets. In
general, an interested stockholder is any entity or
person beneficially owning 15% or more of Critical
Therapeutics outstanding voting stock and any entity or
person affiliated with or controlling or controlled by such
entity or person. The restrictions contained in Section 203
of the Delaware General Corporation Law are not applicable to
any of Critical Therapeutics existing stockholders.
Staggered
Board
Critical Therapeutics certificate of incorporation and its
bylaws divide its board of directors into three classes with
staggered three-year terms. In addition, Critical
Therapeutics certificate of incorporation and its bylaws
provide that directors may be removed only for cause and only by
the affirmative vote of the holders of 75% of Critical
Therapeutics shares of capital stock present in person or
by proxy and entitled to vote. Under
337
Critical Therapeutics certificate of incorporation, any
vacancy on Critical Therapeutics board of directors,
including a vacancy resulting from an enlargement of its board
of directors, may be filled only by vote of a majority of
Critical Therapeutics directors then in office. The
classification of Critical Therapeutics board of directors
and the limitations on the removal of directors and filling of
vacancies could make it more difficult for a third party to
acquire, or discourage a third party from seeking to acquire,
control of Critical Therapeutics.
Stockholder
Action; Special Meeting of Stockholders; Advance Notice
Requirements for Stockholder Proposals and Director
Nominations
Critical Therapeutics certificate of incorporation and its
bylaws provide that any action required or permitted to be taken
by its stockholders at an annual meeting or special meeting of
stockholders may only be taken if it is properly brought before
the meeting and may not be taken by written action in lieu of a
meeting. Critical Therapeutics certificate of
incorporation also provides that, except as otherwise required
by law, a special meeting of the stockholders can only be called
by Critical Therapeutics chairman of the board, Critical
Therapeutics chief executive officer or Critical
Therapeutics board of directors. Critical
Therapeutics bylaws provide that, except as otherwise
required by law, a special meeting of the stockholders can only
be called by Critical Therapeutics chairman of the board,
Critical Therapeutics chief executive officer, Critical
Therapeutics board of directors or Critical
Therapeutics president (if the president is a different
individual than the chief executive officer). In addition,
Critical Therapeutics bylaws establish an advance notice
procedure for stockholder proposals to be brought before an
annual meeting of stockholders, including proposed nominations
of persons for election to the board of directors. Stockholders
at an annual meeting may only consider proposals or nominations
specified in the notice of meeting or brought before the meeting
by or at the direction of the board of directors or by a
stockholder of record on the record date for the meeting, who is
entitled to vote at the meeting and who has delivered timely
written notice in proper form to Critical Therapeutics
secretary of the stockholders intention to bring such
business before the meeting. These provisions could have the
effect of delaying until the next stockholder meeting
stockholder actions that are favored by the holders of a
majority of Critical Therapeutics outstanding voting
securities.
Super-Majority
Voting
The Delaware General Corporation Law provides generally that the
affirmative vote of a majority of the shares entitled to vote on
any matter is required to amend a corporations certificate
of incorporation or bylaws, unless a corporations
certificate of incorporation or bylaws, as the case may be,
requires a greater percentage. Critical Therapeutics
bylaws may be amended or repealed by a majority vote of its
board of directors or the affirmative vote of the holders of at
least 75% of the votes which all its stockholders would be
entitled to cast in any annual election of directors. In
addition, the affirmative vote of the holders of at least 75% of
the votes which all Critical Therapeutics stockholders
would be entitled to cast in any election of directors is
required to amend or repeal or to adopt any provisions
inconsistent with any of the provisions of Critical
Therapeutics certificate of incorporation described in the
prior two paragraphs.
Limitation
of Liability and Indemnification of Officers and
Directors
Critical Therapeutics certificate of incorporation
contains provisions permitted under the Delaware General
Corporation Law relating to the liability of directors. The
provisions eliminate a directors liability for monetary
damages for a breach of fiduciary duty, except to the extent
that the Delaware General Corporation Law prohibits the
elimination or limitation of liability of directors for breaches
of fiduciary duty. Further, Critical Therapeutics
certificate of incorporation contains provisions to indemnify
Critical Therapeutics directors and officers to the
fullest extent permitted by the Delaware General Corporation Law.
338
COMPARISON
OF RIGHTS OF HOLDERS OF CRITICAL THERAPEUTICS STOCK AND
CORNERSTONES COMMON STOCK
Both Critical Therapeutics and Cornerstone are incorporated
under the laws of the State of Delaware and, accordingly, the
rights of the stockholders of each are currently, and will
continue to be, governed by the Delaware General Corporation
Law. If the merger is completed, Cornerstones stockholders
will become stockholders of Critical Therapeutics, and their
rights will be governed by the Delaware General Corporation Law,
the certificate of incorporation of Critical Therapeutics, as
amended, including as described in Proposal 2 and
Proposal 3 to the extent applicable, and the bylaws of
Critical Therapeutics.
The following is a summary of the material differences between
the rights of Critical Therapeutics stockholders and the
rights of Cornerstones stockholders under each
companys respective certificate of incorporation and
bylaws. While Critical Therapeutics believes that this summary
covers the material differences between the two, this summary
may not contain all of the information that is important to you.
This summary is not intended to be a complete discussion of the
respective rights of Critical Therapeutics and
Cornerstones stockholders and is qualified in its entirety
by reference to the Delaware General Corporation Law and the
various documents of Critical Therapeutics and Cornerstone that
are referred to in this summary. You should carefully read this
entire proxy statement/prospectus and the other documents
referred to in this proxy statement/prospectus for a more
complete understanding of the differences between being a
stockholder of Critical Therapeutics and being a stockholder of
Cornerstone. Critical Therapeutics has filed copies of its
certificate of incorporation and bylaws with the SEC, which are
exhibits to the registration statement of which this proxy
statement/prospectus is a part, and will send copies of these
documents to you upon your request.
|
|
|
|
|
|
|
Critical Therapeutics
|
|
Cornerstone
|
|
Authorized Capital Stock
|
|
Critical Therapeutics amended and restated certificate of
incorporation authorizes the issuance of up to
90,000,000 shares of common stock, par value $0.001 per
share, and 5,000,000 shares of preferred stock, par value
$0.001 per share.
|
|
Cornerstones amended certificate of incorporation
authorizes the issuance of up to 50,000,000 shares of
common stock, par value $0.0001 per share.
|
Number of Directors
|
|
Critical Therapeutics amended and restated bylaws provide
that the number of directors be established by the board of
directors, subject to the rights of holders of any series of
preferred stock to elect directors. Critical Therapeutics
board of directors currently consists of four directors.
|
|
Cornerstones amended and restated bylaws provide that the
number of directors shall be determined from time to time by
resolution of the stockholders or the board of directors, but in
no event shall be less than one. Cornerstones board of
directors currently consists of two directors.
|
Stockholder Nominations
|
|
Critical Therapeutics amended and restated bylaws provide
that in order for a stockholder to make a director nomination or
propose business at an annual meeting of the stockholders, the
stockholder must give timely written notice to Critical
Therapeutics Secretary not less than the
90th
day nor later than the
120th
day prior to the first anniversary of the preceding
years annual meeting (with certain adjustments if the date
of the annual meeting is advanced by more than 20 days or
delayed by more than 60 days from the first anniversary of
the preceding years annual meeting, and in order for a
stockholder to make a director nomination at a special meeting
|
|
Cornerstones amended certificate of incorporation and
amended and restated bylaws do not contain provisions relating
to stockholder nominations and proposals.
|
339
|
|
|
|
|
|
|
Critical Therapeutics
|
|
Cornerstone
|
|
|
|
of the stockholders, the stockholder must give timely written
notice to Critical Therapeutics Secretary not less than
the 120th
day prior to such special meeting nor later than the
close of business on the later of (i) the
90th
day prior to such special meeting and (ii) the
10th
day following the day on which the notice of the
date of such special meeting was mailed or public disclosure of
such special meeting was made.
|
|
|
Classification of Directors
|
|
Critical Therapeutics amended and restated certificate of
incorporation and amended and restated bylaws provide that the
board of directors is divided into three classes: Class I,
Class II and Class III. Each director serves for a term
ending on the date of the third annual meeting following the
annual meeting at which such director was elected.
|
|
Cornerstones board of directors is not divided into
classes.
|
Removal of Directors
|
|
Under Critical Therapeutics amended and restated
certificate of incorporation and amended and restated bylaws, a
director may be removed from office only with cause by the
affirmative vote of the holders of 75% of the votes which all
the stockholders would be entitled to cast in any annual
election of directors or class of directors, subject to the
rights of holders of any series of preferred stock.
|
|
Under Cornerstones amended and restated bylaws, a director
may be removed from office with or without cause by a vote of
the holders of a majority of the outstanding shares entitled to
vote at an election of directors.
|
Filling Vacancies on the Board of Directors
|
|
Critical Therapeutics amended and restated certificate of
incorporation and amended and restated bylaws provide that any
vacancy or newly created directorships in the board of directors
shall be filled only by vote of a majority of the directors in
office, although less than a quorum, or by a sole remaining
director and shall not be filled by the stockholders, subject to
the rights of holders of any series of preferred stock. A
director elected to fill a vacancy shall hold office until the
next election of the class for which such director shall have
been chosen, subject to the election and qualification of a
successor and to such directors earlier death, resignation
or removal.
|
|
Cornerstones amended and restated bylaws provide that any
vacancy or newly created directorships in the board of directors
may be filled by vote of a majority of the directors in office,
or, if the directors remaining in office constitute less than a
quorum, by the affirmative vote of a majority of all remaining
directors, or by the sole remaining director. If the vacant
office was held by a director elected by a voting group, only
the remaining director or directors elected by that voting group
or the holders of shares of that voting group are entitled to
fill the vacancy. A director elected to fill a vacancy shall be
elected for the unexpired term of such directors
predecessor in office. The stockholders may elect a director at
any time to fill any vacancy not filled by the directors.
|
Stockholder Action by Written Consent
|
|
Critical Therapeutics amended and restated certificate of
incorporation and amended and restated bylaws specify
|
|
Cornerstones amended and restated bylaws permit any action
which is required or permitted to be taken at a
|
340
|
|
|
|
|
|
|
Critical Therapeutics
|
|
Cornerstone
|
|
|
|
that no action shall be taken by the stockholders by written
consent in lieu of a meeting.
|
|
meeting of the stockholders to be taken without a meeting,
without prior notice and without a vote, if a consent in
writing, setting forth the action so taken, is signed and dated
by the holders of outstanding stock having not less than the
minimum number of votes that would be necessary to authorize or
take such action at a meeting at which all shares entitled to
vote thereon were present and voted. Stockholders may act by
written consent to elect directors; provided, however, that, if
such consent is less than unanimous, such action by written
consent may be in lieu of holding an annual meeting only if all
of the directorships to which directors could be elected at an
annual meeting held at the effective time of such action are
vacant and are filled by such action.
|
Notice of Annual Meeting
|
|
Under Critical Therapeutics amended and restated bylaws,
written notice of the annual meeting must include the date, time
and place of such meeting and the means of remote
communications, if any, by which stockholders and proxyholders
may be deemed to be present in person and vote at such meeting.
Notice shall be given not less than 10 nor more than
60 days prior to the annual meeting to each stockholder
entitled to vote at such meeting.
|
|
Under Cornerstones amended and restated bylaws, written
notice of the annual meeting must include the time and place of
such meeting and the means of remote communications, if any, by
which stockholders and proxy holders may be deemed to be present
in person and vote at such meeting. Notice shall be given not
less than 10 nor more than 60 days prior to the annual
meeting to each stockholder of record entitled to vote at such
meeting.
|
Special Meeting of Stockholders
|
|
Critical Therapeutics amended and restated certificate of
incorporation provides that a special meeting of stockholders
may be called by the board of directors, the chairman of the
board or the chief executive officer, but such special meetings
may not be called by any other person or persons. Critical
Therapeutics amended and restated bylaws provides that a
special meeting of stockholders may be called by the board of
directors, the chairman of the board, the chief executive
officer or the president (if the president shall be a different
individual than the chief executive officer), but such special
meetings may not be called by any other person or persons.
Stockholders are not entitled to call special meetings of
stockholders unless permitted under the Delaware General
Corporation Law. Written notice of special meetings must
|
|
Cornerstones amended and restated bylaws provide that
special meetings of the stockholders may be called at any time
by the President, the Secretary, or the board of directors of
Cornerstone, but such special meetings may not be called by any
other person or persons.
|
341
|
|
|
|
|
|
|
Critical Therapeutics
|
|
Cornerstone
|
|
|
|
include the date, time, place and purpose of such meeting and
the means of remote communications, if any, by which
stockholders and proxyholders may be deemed to be present in
person and vote at such meeting. Notice shall be given not less
than 10 nor more than 60 days prior to the special meeting
to each stockholder entitled to vote at such meeting.
|
|
|
Amendment of Certificate of Incorporation
|
|
Critical Therapeutics amended and restated certificate of
incorporation provides that Critical Therapeutics reserves the
right to amend, alter, change or repeal any provision of the
certificate of incorporation.
|
|
Cornerstones amended certificate of incorporation provides
that Cornerstone reserves the right to amend or repeal any
provision of the certificate of incorporation.
|
Amendment of Bylaws
|
|
Critical Therapeutics amended and restated certificate of
incorporation provides that the affirmative vote of the holders
of at least 75% of the votes which all the stockholders would be
entitled to cast in any annual election of directors or class of
directors may adopt, amend, alter or repeal the bylaws, and the
board of directors also has the power to adopt, amend, alter or
repeal the bylaws by an affirmative vote of a majority of the
directors present at any regular or special meeting of the board
of directors at which a quorum is present, subject to the terms
of any series of preferred stock.
|
|
Cornerstones amended certificate of incorporation provides
that the board of directors is authorized to adopt, amend or
repeal the bylaws. Cornerstones amended and restated
bylaws provide that the bylaws may be amended or repealed and
new bylaws may be adopted by the affirmative vote of the holders
of a majority of the voting power of Cornerstone, or by the
affirmative vote of a majority of the directors then holding
office at any regular or special meeting of the board of
directors or by unanimous written consent.
|
Voting Stock
|
|
Under Critical Therapeutics amended and restated
certificate of incorporation, the holders of common stock are
entitled to vote at all meetings of the stockholders and shall
be entitled to one vote for each share of stock held by them
respectively; provided however, that the holders of common stock
are not entitled to vote on any amendment to the certificate of
incorporation that relates solely to the terms of one or more
outstanding series of preferred stock if the holders of such
affected stock are entitled, either separately or together as a
class with the holders of one or more other such series, to vote
thereon. The voting rights of the holders of common stock are
subject to and qualified by the rights of the holders of
preferred stock of any series as may be designated by the board
of directors upon any issuance of preferred stock of any series.
|
|
Under Cornerstones amended and restated bylaws, each
stockholder is entitled to one vote for each share of capital
stock of Cornerstone held by such stockholder on each matter
submitted to a vote at a meeting of stockholders.
|
342
|
|
|
|
|
|
|
Critical Therapeutics
|
|
Cornerstone
|
|
Conversion Rights and Protective Provisions
|
|
Under Critical Therapeutics amended and restated
certificate of incorporation, holders of Critical Therapeutics
stock have no preemptive or other rights.
|
|
Under Cornerstones amended certificate of incorporation,
holders of Cornerstone stock have no preemptive rights,
conversion rights, protective provisions, nor any other rights.
|
Dividends
|
|
Critical Therapeutics amended and restated certificate of
incorporation provides that dividends may be declared and paid
on the common stock from funds lawfully available therefor as
and when determined by the board of directors and subject to any
preferential dividend or other rights of any then outstanding
preferred stock.
|
|
Cornerstones amended and restated bylaws provide that the
board of directors may from time to time declare, and
Cornerstone may pay, dividends on outstanding shares.
|
Indemnification and Limitation of Liability
|
|
Critical Therapeutics amended and restated certificate of
incorporation provides that directors are not personally liable
to Critical Therapeutics or its stockholders for monetary
damages for any breach of fiduciary duty as a director, except
to the extent that the Delaware General Corporation Law
prohibits the elimination or limitation of liability of
directors for breaches of fiduciary duty. Critical
Therapeutics amended and restated certificate of
incorporation provides that Critical Therapeutics shall
indemnify each person who was or is a party or threatened to be
made a party to any threatened, pending or completed action,
suit or proceeding, whether civil, criminal, administrative or
investigative, by reason of the fact that he or she is or was,
or has agreed to become, a director or officer of Critical
Therapeutics, or is or was serving, or has agreed to serve, at
the request of Critical Therapeutics, as a director, officer,
partner, employee or trustee of, or in a similar capacity with,
another corporation, partnership, joint venture, trust or other
enterprise, against all expenses (including attorneys
fees), judgments, fines and amounts paid in settlement actually
and reasonably incurred by or on behalf of such person in
connection with such action, suit or proceeding and any appeal
therefrom.
|
|
Cornerstones amended certificate of incorporation provides
that directors are not personally liable to Cornerstone or its
stockholders for monetary damages for breach of fiduciary duty
as a director, except to the extent that the elimination or
limitation of liability is not permitted under the Delaware
General Corporation Law. Cornerstones amended and restated
bylaws provide that any person who at any time serves or has
served (i) as a director, officer, employee or agent of
Cornerstone, (ii) at the request of Cornerstone as a
director, officer, partner, trustee, employee or agent of
another foreign or domestic corporation, partnership, joint
venture, trust, or other enterprise, or (iii) at the
request of Cornerstone as a trustee or administrator under an
employee benefit plan, or is called as a witness at a time when
he or she has not been made a named defendant or respondent to
any proceeding, shall have a right to be indemnified by
Cornerstone to the fullest extent from time to time permitted by
law against liability and expenses in any proceeding (including
without limitation a proceeding brought by or on behalf of
Cornerstone itself), arising out of his or her status as such or
activities in any of the foregoing capacities.
|
343
PRINCIPAL
STOCKHOLDERS OF CRITICAL THERAPEUTICS
The following table sets forth information regarding beneficial
ownership of Critical Therapeutics common stock as of
September 15, 2008 by:
|
|
|
|
|
each person, entity or group of affiliated persons or entities
known to Critical Therapeutics to be the beneficial owner of
more than 5% of the outstanding shares of Critical Therapeutics
common stock;
|
|
|
|
each member of Critical Therapeutics board of directors;
|
|
|
|
Critical Therapeutics President and Chief Executive
Officer, Chief Financial Officer and two other executive
officers who were serving as executive officers on
December 31, 2007, Critical Therapeutics former
President and Chief Executive Officer and one additional former
executive officer who would have been among its most highly
compensated executive officers if he had been serving as an
executive officer on December 31, 2007; and
|
|
|
|
all of Critical Therapeutics directors and executive
officers as a group.
|
Beneficial ownership is determined in accordance with the
applicable rules of the SEC and includes voting or investment
power with respect to shares of Critical Therapeutics
common stock. Shares of common stock issuable under stock
options and warrants that are currently exercisable or
exercisable within 60 days of September 15, 2008 are
deemed to be beneficially owned by the person holding the option
or warrant for purposes of calculating the percentage ownership
of that person but are not deemed outstanding for purposes of
calculating the percentage ownership of any other person. The
information set forth below is not necessarily indicative of
beneficial ownership for any other purpose, and the inclusion of
any shares deemed beneficially owned in this table does not
constitute an admission of beneficial ownership of those shares.
Unless otherwise indicated, to Critical Therapeutics
knowledge, all persons named in the table have sole voting and
investment power with respect to the shares of common stock
beneficially owned by them, except, where applicable, to the
extent authority is shared by spouses under community property
laws.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
Shares
|
|
Shares
|
|
|
|
|
|
|
Outstanding
|
|
Underlying
|
|
Underlying
|
|
Total Number of
|
|
Percentage of
|
|
|
Shares
|
|
Warrants
|
|
Options
|
|
Shares
|
|
Common Stock
|
|
|
Beneficially
|
|
Currently
|
|
Exercisable
|
|
Beneficially
|
|
Beneficially
|
Name and Address of Beneficial Owner(1)
|
|
Owned
|
|
Exercisable(2)
|
|
within 60 Days
|
|
Owned
|
|
Owned
|
|
5% Stockholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Funds managed by Healthcare Ventures(3)
|
|
|
5,153,323
|
|
|
|
383,212
|
|
|
|
|
|
|
|
5,536,535
|
|
|
|
12.7
|
%
|
44 Nassau Street, Second Floor
Princeton, NJ 08542
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Funds managed by Advanced Technology Ventures(4)
|
|
|
3,182,132
|
|
|
|
447,081
|
|
|
|
|
|
|
|
3,629,213
|
|
|
|
8.3
|
%
|
Bay Colony Corporate Center
1000 Winter Street, Suite 3700
Waltham, MA 02541
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MedImmune Ventures, Inc.(5)
|
|
|
2,663,642
|
|
|
|
|
|
|
|
|
|
|
|
2,663,642
|
|
|
|
6.2
|
%
|
One MedImmune Way
Gaithersburg, MD 20878
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Directors and Named Executive Officers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trevor Phillips, Ph.D.(6)
|
|
|
85,824
|
|
|
|
|
|
|
|
565,088
|
|
|
|
650,912
|
|
|
|
1.5
|
%
|
President and Chief Executive Officer and Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Christopher Mirabelli, Ph.D.(7)
|
|
|
5,153,323
|
|
|
|
383,212
|
|
|
|
|
|
|
|
5,536,535
|
|
|
|
12.7
|
%
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jean George(8)
|
|
|
3,182,132
|
|
|
|
447,081
|
|
|
|
35,000
|
|
|
|
3,664,213
|
|
|
|
8.4
|
%
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Richard W. Dugan
|
|
|
|
|
|
|
|
|
|
|
60,000
|
|
|
|
60,000
|
|
|
|
*
|
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
344
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
Shares
|
|
Shares
|
|
|
|
|
|
|
Outstanding
|
|
Underlying
|
|
Underlying
|
|
Total Number of
|
|
Percentage of
|
|
|
Shares
|
|
Warrants
|
|
Options
|
|
Shares
|
|
Common Stock
|
|
|
Beneficially
|
|
Currently
|
|
Exercisable
|
|
Beneficially
|
|
Beneficially
|
Name and Address of Beneficial Owner(1)
|
|
Owned
|
|
Exercisable(2)
|
|
within 60 Days
|
|
Owned
|
|
Owned
|
|
Thomas P. Kelly(9)
|
|
|
90,700
|
|
|
|
|
|
|
|
43,749
|
|
|
|
134,449
|
|
|
|
*
|
|
Chief Financial Officer and Senior Vice President of Finance
and Corporate Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott B. Townsend, Esq.(10)
|
|
|
94,868
|
|
|
|
|
|
|
|
167,015
|
|
|
|
261,883
|
|
|
|
*
|
|
Senior Vice President of Legal Affairs, General Counsel and
Secretary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jeffrey E. Young(11)
|
|
|
52,469
|
|
|
|
|
|
|
|
90,254
|
|
|
|
142,723
|
|
|
|
*
|
|
Vice President of Finance, Chief Accounting Officer and
Treasurer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Frank E. Thomas(12)
|
|
|
52,033
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Former President and Chief Executive Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dana Hilt, M.D.(13)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Former Chief Medical Officer and Senior Vice President of
Clinical Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All executive officers and directors as a group (7 persons,
consisting of 4 officers and 3 non-employee directors)
|
|
|
8,659,316
|
|
|
|
830,293
|
|
|
|
961,106
|
|
|
|
10,450,715
|
|
|
|
23.2
|
%
|
|
|
|
* |
|
Represents beneficial ownership of less than one percent of
common stock. |
|
(1) |
|
Unless otherwise indicated, the address of each beneficial owner
is care of Critical Therapeutics, Inc., 60 Westview Street,
Lexington, MA 02421. |
|
(2) |
|
Consists of shares underlying warrants to purchase common stock
at $6.58 per share issued in connection with a private placement
of common stock and warrants in June 2005. |
|
(3) |
|
Consists of 4,058,432 shares of common stock held by
HealthCare Ventures VI, L.P. and 1,094,891 shares of common
stock and warrants to purchase 383,212 shares of common
stock held by HealthCare Ventures VII, L.P. Christopher
Mirabelli, a member of the board of directors, is a General
Partner of HealthCare Partners VI, L.P., the general partner of
HealthCare Ventures VI, L.P., and a General Partner of
HealthCare Partners VII, L.P., the general partner of HealthCare
Ventures VII, L.P. Dr. Mirabelli disclaims beneficial
ownership of the shares held by the funds managed by HealthCare
Ventures, except to the extent of his pecuniary interest therein. |
|
(4) |
|
Consists of 2,554,802 shares of common stock and warrants
to purchase 359,696 shares of common stock held by Advanced
Technology Ventures VII, L.P.; 102,522 shares of common
stock and warrants to purchase 14,434 shares of common
stock held by Advanced Technology Ventures VII (B), L.P.;
49,279 shares of common stock and warrants to purchase
6,938 shares of common stock held by Advanced Technology
Ventures VII (C), L.P.; 15,225 shares of common stock and
warrants to purchase 2,144 shares of common stock held by
ATV Entrepreneurs VII, L.P.; 5,714 shares of common stock
held by ATV Alliance 2003, L.P.; 427,315 shares of common
stock and warrants to purchase 60,037 shares of common
stock held by Advanced Technology Ventures VI, L.P.; and
27,275 shares of common stock and warrants to purchase
3,832 shares of common stock held by ATV Entrepreneurs VI,
L.P. Jean George, a member of the board of directors, is a
Managing Director of the general partner of certain of the funds
managed by Advanced Technology Ventures. Ms. George
disclaims beneficial ownership of the shares held by the funds
managed by Advanced Technology Ventures, except to the extent of
her pecuniary interest therein. |
345
|
|
|
(5) |
|
MedImmune Ventures, Inc. is a wholly owned, indirect subsidiary
of AstraZeneca PLC, a publicly traded company. |
|
(6) |
|
Includes 17,500 shares of restricted stock issued to
Dr. Phillips in December 2006 that will vest in December
2008 and 25,000 shares of restricted stock issued to
Dr. Phillips in November 2007 that will vest in November
2009. In addition, includes 3,200 shares of common stock
held by Dr. Phillips children. Dr. Phillips
disclaims beneficial ownership of the foregoing
3,200 shares held by his children except to the extent of
his pecuniary interest therein. Dr. Phillips was elected as
a director effective March 4, 2008 and appointed as
President and Chief Executive Officer effective April 1,
2008. |
|
(7) |
|
Consists of 5,153,323 shares of common stock and warrants
to purchase 383,212 shares of common stock held by funds
managed by HealthCare Ventures. Dr. Mirabelli is a general
partner of HealthCare Partners VI, L.P., the general partner of
HealthCare Ventures VI, L.P., and a General Partner of
HealthCare Partners VII, L.P., the general partner of HealthCare
Ventures VII, L.P. Dr. Mirabelli disclaims beneficial
ownership of the shares held by the funds managed by HealthCare
Ventures, except to the extent of his pecuniary interest therein. |
|
(8) |
|
Includes 3,182,132 shares of common stock and warrants to
purchase 447,081 shares of common stock held by funds
managed by Advanced Technology Ventures. Ms. George is a
Managing Director of the general partner of certain of the funds
managed by Advanced Technology Ventures. Ms. George
disclaims beneficial ownership of the shares held by the funds
managed by Advanced Technology Ventures, except to the extent of
her pecuniary interest therein. |
|
(9) |
|
Includes (i) 13,350 shares of restricted stock issued
to Mr. Kelly in August 2007 that will vest in August 2009,
(ii) 12,500 shares of restricted stock issued to
Mr. Kelly in November 2007 that will vest in November 2009
and (iii) 17,500 shares of restricted stock issued to
Mr. Kelly in February 2008 that will vest in February 2010. |
|
(10) |
|
Includes (i) 13,350 shares of restricted stock issued
to Mr. Townsend in December 2006 that will vest in December
2008, (ii) 12,500 shares of restricted stock issued to
Mr. Townsend in November 2007 that will vest in November
2009 and (iii) 17,500 shares of restricted stock
issued to Mr. Townsend in February 2008 that will vest in
February 2010. |
|
(11) |
|
Includes 13,350 shares of restricted stock issued to
Mr. Young in December 2006 that will vest in December 2008
and 12,500 shares of restricted stock issued to
Mr. Young in November 2007 that will vest in November 2009. |
|
(12) |
|
Mr. Thomas resigned as a director effective March 2,
2008 and as President and Chief Executive Officer effective
March 31, 2008. |
|
(13) |
|
Dr. Hilt resigned as Chief Medical Officer and Senior Vice
President of Clinical Development effective September 25,
2007. |
346
PRINCIPAL
STOCKHOLDERS OF CORNERSTONE
The following table sets forth information regarding beneficial
ownership of Cornerstones common stock as of
September 15, 2008 by:
|
|
|
|
|
each person, entity or group of affiliated persons or entities
known to Cornerstone to be the beneficial owner of more than 5%
of the outstanding shares of Cornerstones common stock;
|
|
|
|
each of member of Cornerstones board of directors;
|
|
|
|
Cornerstones (i) President and Chief Executive
Officer, (ii) Vice President Sales and Marketing,
(iii) Chief Medical Officer, (iv) Executive Vice
President Commercial Operations, (v) Vice President,
Finance and (vi) Executive Vice President, Finance, and
Chief Financial Officer; and
|
|
|
|
all of Cornerstones directors and executive officers as a
group.
|
Beneficial ownership is determined in accordance with the
applicable rules of the SEC and includes voting or investment
power with respect to shares of Cornerstones common stock.
Shares of common stock issuable under stock options and warrants
that are currently exercisable or exercisable within
60 days of September 15, 2008 are deemed to be
beneficially owned by the person holding the option or warrant
for purposes of calculating the percentage ownership of that
person but are not deemed outstanding for purposes of
calculating the percentage ownership of any other person. The
information set forth below is not necessarily indicative of
beneficial ownership for any other purpose, and the inclusion of
any shares deemed beneficially owned in this table does not
constitute an admission of beneficial ownership of those shares.
Unless otherwise indicated, to Cornerstones knowledge, all
persons named in the table have sole voting and investment power
with respect to the shares of common stock beneficially owned by
them, except, where applicable, to the extent authority is
shared by spouses under community property laws.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
Shares
|
|
Shares
|
|
|
|
|
|
|
Outstanding
|
|
Underlying
|
|
Underlying
|
|
Total Number
|
|
Percentage of
|
|
|
Shares
|
|
Warrants
|
|
Options
|
|
of Shares
|
|
Common Stock
|
Name and Address of
|
|
Beneficially
|
|
Currently
|
|
Exercisable
|
|
Beneficially
|
|
Beneficially
|
Beneficial Owner(1)
|
|
Owned
|
|
Exercisable(2)
|
|
within 60 Days
|
|
Owned
|
|
Owned
|
|
5% Stockholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Craig A. Collard(3)
|
|
|
13,450,000
|
|
|
|
|
|
|
|
300,000
|
|
|
|
13,750,000
|
|
|
|
54.5
|
%
|
President and Chief Executive Officer and Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cornerstone Biopharma Holdings, Ltd.(4)
|
|
|
13,450,000
|
|
|
|
|
|
|
|
|
|
|
|
13,450,000
|
|
|
|
54.0
|
%
|
Steven M. Lutz(5)
|
|
|
2,845,000
|
|
|
|
|
|
|
|
281,250
|
|
|
|
3,126,250
|
|
|
|
12.4
|
%
|
Executive Vice President, Commercial Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lutz Family Limited Partnership(6)
|
|
|
2,845,000
|
|
|
|
|
|
|
|
|
|
|
|
2,845,000
|
|
|
|
11.4
|
%
|
James V. Baker(7)
|
|
|
3,100,000
|
|
|
|
|
|
|
|
50,000
|
|
|
|
3,150,000
|
|
|
|
12.6
|
%
|
ProPharm Investments, LLC(8)
|
|
|
|
|
|
|
1,311,903
|
|
|
|
|
|
|
|
1,311,903
|
|
|
|
5.0
|
%
|
Other Directors and Named Executive Officers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chenyqua Baldwin(9)
|
|
|
750,000
|
|
|
|
|
|
|
|
242,500
|
|
|
|
992,500
|
|
|
|
3.9
|
%
|
Vice President, Finance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brian Dickson, M.D.(10)
|
|
|
|
|
|
|
|
|
|
|
668,750
|
|
|
|
668,750
|
|
|
|
2.6
|
%
|
Chief Medical Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
George Esgro(11)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Vice President Sales and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alastair McEwan(12)
|
|
|
|
|
|
|
|
|
|
|
1,125,000
|
|
|
|
1,125,000
|
|
|
|
4.3
|
%
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Price(13)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Executive Vice President, Finance, and Chief Financial
Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All directors and executive officers as a group (7 persons,
consisting of 6 officers and 1 employee director)
|
|
|
17,045,000
|
|
|
|
|
|
|
|
2,617,500
|
|
|
|
19,662,500
|
|
|
|
71.4
|
%
|
347
|
|
|
* |
|
Represents beneficial ownership of less than one percent of
common stock. |
|
(1) |
|
Unless otherwise indicated, the address of each beneficial owner
is care of Cornerstone BioPharma Holdings, Inc., 2000 Regency
Parkway, Suite 255 Cary, NC 27518. |
|
(2) |
|
Consists of shares underlying a warrant to purchase common stock
issued to ProPharm Investments, LLC in July 2006. The warrant
exercise price is $50,000 and the warrant is exercisable for a
number of shares such that after issuance of the warrant shares,
ProPharm Investments, LLC will own 5% of Cornerstones
outstanding common stock as of the date of the warrant is
surrendered to Cornerstone. The shares listed assume that the
number of shares of Cornerstone common stock outstanding on the
date of warrant exercise is the same as the number of shares of
Cornerstone common stock outstanding on September 15, 2008.
The right to exercise the warrant will terminate as of the
effective time of the merger. Cornerstone is required to give
ProPharm Investments, LLC advance notice of the proposed merger
so that ProPharm Investments, LLC can determine whether to
exercise its option to purchase shares under the warrant in
advance of the effective time. |
|
(3) |
|
Consists of 13,450,000 shares of common stock held by
Cornerstone Biopharma Holdings, Ltd. and options to purchase
300,000 shares of common stock pursuant to stock option
grants awarded to Mr. Collard under Cornerstones 2005
Stock Incentive Plan. Mr. Collard is the controlling
stockholder and a director of Cornerstone Biopharma Holdings,
Ltd. Mr. Collard disclaims beneficial ownership of the
shares held by Cornerstone Biopharma Holdings, Ltd., except to
the extent of his pecuniary interest therein. |
|
(4) |
|
Mr. Collard is the controlling shareholder and a director of
Cornerstone Biopharma Holdings, Ltd. and exercises voting and
investment power with respect to the shares of Cornerstone owned
by Cornerstone Biopharma Holdings, Ltd. |
|
(5) |
|
Consists of 2,845,000 shares of common stock held by the
Lutz Family Limited Partnership and options to purchase
256,250 shares and 25,000 shares of common stock
pursuant to stock option grants awarded to Mr. Lutz under
Cornerstones 2005 Stock Incentive Plan and 2005 Stock
Option Plan, respectively. Mr. Lutz has or shares voting
and investment power over the shares of Cornerstones
common stock held by the Lutz Family Limited Partnership by
virtue of his serving as general partner of the Lutz Family
Limited Partnership. Mr. Lutz disclaims beneficial
ownership of the shares held by the Lutz Family Limited
Partnership, except to the extent of his pecuniary interest
therein. |
|
(6) |
|
Mr. Lutz exercises voting and investment power with respect to
the shares of Cornerstone owned by the Lutz Family Limited
Partnership by virtue of his serving as general partner of the
Lutz Family Limited Partnership. |
|
(7) |
|
Consists of 3,100,000 shares of common stock and options to
purchase 50,000 shares of common stock pursuant to stock
option grants awarded to Mr. Baker under Cornerstones
2005 Stock Incentive Plan. |
|
(8) |
|
William S. Propst Jr. exercises voting and investment power
with respect to the shares of Cornerstone owned by ProPharm
Investments, LLC. |
|
(9) |
|
Consists of 750,000 shares of restricted stock and options
to purchase 202,500 shares and 40,000 shares of common
stock pursuant to stock option grants awarded to
Ms. Baldwin under Cornerstones 2005 Stock Incentive
Plan and 2005 Stock Option Plan, respectively. |
|
(10) |
|
Consists of options to purchase 668,750 shares of common
stock pursuant to stock option grants awarded to
Dr. Dickson under Cornerstones 2005 Stock Incentive
Plan. |
|
(11) |
|
Pursuant to the Employment Agreement, dated March 3, 2008,
between Cornerstone and Mr. Esgro, Cornerstone is obligated
to grant Mr. Esgro an option to purchase
300,000 shares of Cornerstone common stock. Cornerstone
expects that the option award to Mr. Esgro will be
completed immediately prior to the effective time of the merger. |
|
(12) |
|
Consists of options to purchase 1,125,000 shares of common
stock pursuant to stock option grants awarded to Mr. McEwan
under Cornerstones 2005 Stock Incentive Plan. |
|
(13) |
|
Mr. Price became the Executive Vice President, Finance, and
Chief Financial Officer of Cornerstone effective as of
September 8, 2008. Pursuant to the Executive Employment
Agreement, dated August 20, 2008, between Cornerstone and
Mr. Price, Cornerstone is obligated to issue to
Mr. Price 1,301,776 restricted shares of Cornerstone common
stock. Cornerstone expects that this restricted stock award to
Mr. Price will be completed immediately prior to the
effective time of the merger. |
348
PRINCIPAL
STOCKHOLDERS OF COMBINED COMPANY
The following table and the related notes present certain
information with respect to the beneficial ownership of the
combined company upon consummation of the merger, by
(1) each director and executive officer of the combined
company, (2) each person or group who is known to the
management of Critical Therapeutics and Cornerstone to become
the beneficial owner of more than 5% of the common stock of the
combined company upon the consummation of the merger and
(3) all directors and executive officers of the combined
company as a group. Unless otherwise indicated in the footnotes
to this table and subject to the voting agreements entered into
by directors and executive officers of Critical Therapeutics and
Cornerstone, Critical Therapeutics and Cornerstone believe that
each of the persons named in this table has sole voting and
investment power with respect to the shares indicated as
beneficially owned.
The percent of common stock of Critical Therapeutics is based on
43,332,598 shares of common stock outstanding as of
September 15, 2008. The percent of common stock of
Cornerstone is based on 24,926,150 shares of common stock
outstanding as of September 15, 2008. The percent of common
stock of the combined company is based on
125,258,151 shares of common stock of the combined company
outstanding upon the consummation of the merger and assumes,
among other things, that the merger is consummated on
September 15, 2008, that the exchange ratio of Cornerstone
common stock will be 2.449169 shares of Critical
Therapeutics stock for each share of Cornerstones common
stock, that ProPharm Investments, LLC exercises its warrant
rights in advance of the proposed merger to purchase all shares
of Cornerstones common stock it is entitled to purchase
under its warrant agreement with Cornerstone and that the
Carolina Note is converted into 5,895,525 shares of
Cornerstones common stock immediately before the effective
time of the merger. Shares of Critical Therapeutics common
stock subject to options and warrants that are currently
exercisable or are exercisable within 60 days after
September 15, 2008, are treated as outstanding and
beneficially owned by the person holding them for the purpose of
computing the percentage ownership of Critical
Therapeutics common stock of that person but are not
treated as outstanding for the purpose of computing the
percentage ownership of Critical Therapeutics common stock
of any other person. Shares of Cornerstones common stock
subject to options or warrants that are currently exercisable or
are exercisable within 60 days of September 15, 2008
will be automatically converted at the effective time of the
merger into the right to receive Critical Therapeutics
common stock in lieu of Cornerstones common stock and are
treated as outstanding and beneficially owned by the person
holding them for the purpose of computing the percentage
ownership of common stock of the combined company of that person
but are not treated as outstanding for the purpose of computing
the percentage ownership of common stock of the combined company
of any other stockholder. All share numbers in this table are
subject to adjustment to account for the reverse stock split.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
Shares
|
|
Shares
|
|
|
|
|
|
|
Outstanding
|
|
Underlying
|
|
Underlying
|
|
Total Number
|
|
Percentage of
|
|
|
Shares
|
|
Warrants
|
|
Options
|
|
of Shares
|
|
Common Stock
|
Name and Address of
|
|
Beneficially
|
|
Currently
|
|
Exercisable
|
|
Beneficially
|
|
Beneficially
|
Beneficial Owner(1)
|
|
Owned
|
|
Exercisable
|
|
within 60 Days
|
|
Owned
|
|
Owned
|
|
5% Stockholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Craig A. Collard(2)
|
|
|
47,380,451
|
|
|
|
|
|
|
|
734,750
|
|
|
|
48,115,201
|
|
|
|
38.2
|
%
|
President and Chief Executive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Officer and Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cornerstone Biopharma Holdings, Ltd.(3)
|
|
|
32,941,317
|
|
|
|
|
|
|
|
|
|
|
|
32,941,317
|
|
|
|
26.3
|
%
|
Carolina Pharmaceuticals Ltd.(4)
|
|
|
14,439,134
|
|
|
|
|
|
|
|
|
|
|
|
14,439,134
|
|
|
|
11.5
|
%
|
Steven M. Lutz(5)
|
|
|
6,967,884
|
|
|
|
|
|
|
|
688,828
|
|
|
|
7,656,712
|
|
|
|
6.1
|
%
|
Executive Vice President,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lutz Family Limited Partnership(6)
|
|
|
6,967,884
|
|
|
|
|
|
|
|
|
|
|
|
6,967,884
|
|
|
|
5.6
|
%
|
James V. Baker(7)
|
|
|
7,592,422
|
|
|
|
|
|
|
|
122,458
|
|
|
|
7,714,880
|
|
|
|
6.2
|
%
|
349
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
Shares
|
|
Shares
|
|
|
|
|
|
|
Outstanding
|
|
Underlying
|
|
Underlying
|
|
Total Number
|
|
Percentage of
|
|
|
Shares
|
|
Warrants
|
|
Options
|
|
of Shares
|
|
Common Stock
|
Name and Address of
|
|
Beneficially
|
|
Currently
|
|
Exercisable
|
|
Beneficially
|
|
Beneficially
|
Beneficial Owner(1)
|
|
Owned
|
|
Exercisable
|
|
within 60 Days
|
|
Owned
|
|
Owned
|
|
Other Directors and Named
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Executive Officers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chenyqua Baldwin(8)
|
|
|
1,836,876
|
|
|
|
|
|
|
|
593,923
|
|
|
|
2,430,799
|
|
|
|
1.9
|
%
|
Vice President, Finance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Christopher Codeanne
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brian Dickson, M.D.(9)
|
|
|
|
|
|
|
|
|
|
|
1,637,881
|
|
|
|
1,637,881
|
|
|
|
1.3
|
%
|
Chief Medical Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Enright
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
George Esgro(10)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Vice President Sales and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Heffernan
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alastair McEwan(11)
|
|
|
|
|
|
|
|
|
|
|
2,755,314
|
|
|
|
2,755,314
|
|
|
|
2.2
|
%
|
Director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David Price(12)
|
|
|
3,188,268
|
|
|
|
|
|
|
|
|
|
|
|
3,188,268
|
|
|
|
2.5
|
%
|
Executive Vice President, Finance, and Chief Financial
Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scott B. Townsend, Esq.(13)
|
|
|
1,584,657
|
|
|
|
|
|
|
|
167,015
|
|
|
|
1,751,672
|
|
|
|
1.4
|
%
|
General Counsel, Executive Vice President of Legal Affairs
and Secretary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All directors and executive officers as a group
(10 persons, consisting of 6 officers and 4 non-employee
directors)
|
|
|
60,958,136
|
|
|
|
|
|
|
|
6,577,711
|
|
|
|
67,535,847
|
|
|
|
51.2
|
|
|
|
|
* |
|
Represents beneficial ownership of less than one percent of
common stock. |
|
(1) |
|
Unless otherwise indicated, the address of each beneficial owner
is care of Cornerstone BioPharma Holdings, Inc., 2000 Regency
Parkway, Suite 255 Cary, NC 27518. |
|
(2) |
|
Consists of 32,941,317 shares of common stock held by
Cornerstone Biopharma Holdings, Ltd., 14,439,134 shares of
common stock held by Carolina Pharmaceuticals received in
connection with the conversion of the outstanding principal
amount under the Carolina Note and options to purchase
734,750 shares of common stock pursuant to stock option
grants awarded to Mr. Collard under Cornerstones 2005
Stock Incentive Plan. Mr. Collard is the controlling shareholder
and a director of Cornerstone Biopharma Holdings, Ltd. and by
virtue of such positions will exercise voting and investment
power with respect to the shares of the combined company to be
owned by Cornerstone Biopharma Holdings, Ltd. following the
merger. Mr. Collard is the chief executive officer and chairman
of the board of Carolina Pharmaceuticals and by virtue of such
positions will exercise voting and investment power with respect
to the shares of the combined company to be owned Carolina
Pharmaceuticals following the merger. Mr. Collard disclaims
beneficial ownership of the shares held by Cornerstone Biopharma
Holdings, Ltd. and Carolina Pharmaceuticals, except to the
extent of his pecuniary interest therein. |
350
|
|
|
(3) |
|
Mr. Collard is the controlling shareholder and a director of
Cornerstone Biopharma Holdings, Ltd. and by virtue of such
positions will exercise voting and investment power with respect
to the shares of the combined company to be owned by Cornerstone
Biopharma Holdings, Ltd. following the merger. |
|
(4) |
|
Mr. Collard is the chief executive officer and chairman of the
board of Carolina Pharmaceuticals and by virtue of such
positions will exercise voting and investment power with respect
to the shares of the combined company to be owned Carolina
Pharmaceuticals following the merger. |
|
(5) |
|
Consists of 6,967,884 shares of common stock held by the
Lutz Family Limited Partnership and options to purchase
642,907 shares and 45,921 shares of common stock
pursuant to stock option grants awarded to Mr. Lutz under
Cornerstones 2005 Stock Incentive Plan and 2005 Stock
Option Plan, respectively. Mr. Lutz has or shares voting
and investment power over the shares of Cornerstones
common stock held by the Lutz Family Limited Partnership by
virtue of his serving as general partner of the Lutz Family
Limited Partnership. Mr. Lutz disclaims beneficial
ownership of the shares held by the Lutz Family Limited
Partnership, except to the extent of his pecuniary interest
therein. |
|
(6) |
|
Mr. Lutz is the general partner of the Lutz Family Limited
Partnership and by virtue of such position will exercise voting
and investment power with respect to the shares of the combined
company to be owned by the Lutz Family Limited Partnership
following the merger. |
|
(7) |
|
Consists of 7,592,422 shares of common stock and options to
purchase 122,458 shares of common stock pursuant to stock
option grants awarded to Mr. Baker under Cornerstones
2005 Stock Incentive Plan. |
|
(8) |
|
Consists of 1,836,876 shares of restricted stock and
options to purchase 520,448 shares and 73,475 shares
of common stock pursuant to stock option grants awarded to
Ms. Baldwin under Cornerstones 2005 Stock Incentive
Plan and 2005 Stock Option Plan, respectively. |
|
(9) |
|
Consists of options to purchase 1,637,881 shares of common
stock pursuant to stock option grants awarded to
Dr. Dickson under Cornerstones 2005 Stock Incentive
Plan. |
|
(10) |
|
Pursuant to the Employment Agreement, dated March 3, 2008,
between Cornerstone and Mr. Esgro, Cornerstone is obligated
to grant Mr. Esgro an option to purchase
300,000 shares of Cornerstone common stock. Cornerstone
expects that the option award to Mr. Esgro will be
completed immediately prior to the effective time of the merger
but that none of the options will be currently exercisable or
exercisable within 60 days of the effective time of the
merger. |
|
(11) |
|
Consists of options to purchase 2,755,314 shares of common
stock pursuant to stock option grants awarded to Mr. McEwan
under Cornerstones 2005 Stock Incentive Plan. |
|
(12) |
|
Mr. Price became the Executive Vice President, Finance, and
Chief Financial Officer of Cornerstone effective as of
September 8, 2008. Pursuant to the Restricted Stock
Agreement, dated August 20, 2008, between Cornerstone and
Mr. Price, Cornerstone is obligated to issue to Mr. Price
1,301,776 restricted shares of Cornerstone common stock.
Cornerstone expects that this restricted stock award to Mr.
Price will be completed immediately prior to the effective time
of the merger. In connection with the merger,
Mr. Prices 1,301,776 restricted shares of Cornerstone
common stock will be converted into restricted shares of the
combined companys common stock. |
|
(13) |
|
In anticipation of Mr. Townsends service to the
combined company following the merger, on September 16,
2008, Critical Therapeutics entered into a restricted stock
agreement with Mr. Townsend that provides for a restricted
stock grant to Mr. Townsend on the first business day after
the consummation of the merger for a number of shares of common
stock representing one percent of the combined companys
outstanding equity, on a fully diluted basis but excluding an
aggregate of 7,208,707 shares of Critical
Therapeutics common stock underlying warrants issued in
connection with a June 2005 private placement and an October
2006 registered offering, after giving effect to the reverse
stock split and the merger, subject to the terms of such
restricted stock agreement. The restricted stock agreement will
only become effective if the merger is consummated. It is
expected that approximately 1,489,789 shares will be issued
to Mr. Townsend pursuant to the restricted stock agreement,
subject to adjustment as a result of the reverse stock split.
Also includes options to purchase 167,015 shares of common
stock pursuant to stock option grants awarded to
Mr. Townsend under Critical Therapeutics stock option
plans. Also includes (i) 13,350 shares of restricted
stock issued to Mr. Townsend in |
351
|
|
|
|
|
December 2006 that will vest in December 2008,
(ii) 12,500 shares of restricted stock issued to
Mr. Townsend in November 2007 that will vest in November
2009 and (iii) 17,500 shares of restricted stock
issued to Mr. Townsend in February 2008 that will vest in
February 2010. |
LEGAL
MATTERS
Wilmer Cutler Pickering Hale and Dorr LLP, New York, New York,
is passing upon the validity of the Critical Therapeutics
common stock offered by this proxy statement/prospectus.
Partners of Wilmer Cutler Pickering Hale and Dorr LLP
beneficially own 19,020 shares of Critical
Therapeutics common stock.
EXPERTS
The consolidated financial statements of Critical Therapeutics,
Inc. as of December 31, 2007 and 2006 and for each of the
three years in the period ended December 31, 2007, included
in this proxy statement/prospectus, and the related financial
statement schedule included elsewhere in the registration
statement of which this proxy statement/prospectus forms a part
have been audited by Deloitte & Touche LLP, an
independent registered public accounting firm, as stated in
their report appearing herein (which report expresses an
unqualified opinion on the financial statements and includes
explanatory paragraphs referring to Critical Therapeutics,
Inc.s adoption of Statement of Financial Accounting
Standards No. 123(R), Share-Based Payment, effective
January 1, 2006 and the uncertainty relating to Critical
Therapeutics, Inc.s ability to continue as a going
concern). Such consolidated financial statements and financial
statement schedule have been so included in reliance upon the
report of such firm given upon their authority as experts in
accounting and auditing.
The consolidated financial statements of Cornerstone Biopharma
Holdings, Inc. as of December 31, 2007 and 2006, and for
each of the years ended December 31, 2005, 2006 and 2007,
included in this proxy
statement/prospectus,
have been audited by Grant Thornton LLP, independent registered
public accountants, as indicated in their report with respect
thereto and such consolidated financial statements are included
herein in reliance upon the authority of said firm as experts in
giving said report.
WHERE YOU
CAN FIND MORE INFORMATION
Critical Therapeutics files reports, proxy statements and other
information with the SEC as required by the Exchange Act. You
can find, copy and inspect information Critical Therapeutics
files at the SECs public reference room at
100 F Street, N.E., Room 1580,
Washington, D.C. 20549. You can call the SEC
at 1-800-SEC-0330
for further information about the public reference room. You can
review Critical Therapeutics electronically filed reports,
proxy and information statements on the SECs web site at
http://www.sec.gov
or on Critical Therapeutics web site at
http://www.crtx.com.
Information included on Critical Therapeutics web site is
not a part of this proxy statement/prospectus.
You should rely only on the information contained in this proxy
statement/prospectus or on information to which Critical
Therapeutics has referred you. Critical Therapeutics has not
authorized anyone else to provide you with any information.
Critical Therapeutics provided the information concerning
Critical Therapeutics, and Cornerstone provided the information
concerning Cornerstone, appearing in this proxy
statement/prospectus.
This proxy statement/prospectus is part of a registration
statement that Critical Therapeutics filed with the SEC. The
registration statement contains more information than this proxy
statement/prospectus regarding Critical Therapeutics and the
securities, including exhibits and schedules. You can obtain a
copy of the registration statement from the SEC at any address
listed above or from the SECs web site.
352
INDEX TO
CRITICAL THERAPEUTICS CONSOLIDATED FINANCIAL
STATEMENTS
TABLE OF
CONTENTS
|
|
|
|
|
|
|
Page
|
|
CRITICAL THERAPEUTICS CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
Report of Independent Registered Public Accounting Firm
|
|
|
F-2
|
|
Consolidated Balance Sheets at December 31, 2007 and
December 31, 2006
|
|
|
F-3
|
|
Consolidated Statements of Operations for the Years ended at
December 31, 2007, December 31, 2006 and
December 31, 2005
|
|
|
F-4
|
|
Consolidated Statements of Stockholders Equity and
Comprehensive Loss for the Years ended at December 31,
2007, December 31, 2006 and December 31, 2005
|
|
|
F-5
|
|
Consolidated Statements of Cash Flows for the Years ended at
December 31, 2007, December 31, 2006 and
December 31, 2005
|
|
|
F-6
|
|
Notes to Consolidated Financial Statements
|
|
|
F-7
|
|
CRITICAL THERAPEUTICS CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (UNAUDITED)
|
|
|
|
|
Condensed Consolidated Balance Sheets at June 30, 2008 and
December 31, 2007 (Unaudited)
|
|
|
F-36
|
|
Condensed Consolidated Statements of Operations for the Six
Months ended June 30, 2008 and 2007 (Unaudited)
|
|
|
F-37
|
|
Condensed Consolidated Statements of Cash Flows for the Six
Months ended June 30, 2008 and 2007 (Unaudited)
|
|
|
F-38
|
|
Notes to Unaudited Condensed Consolidated Financial Statements
|
|
|
F-39
|
|
F-1
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Critical Therapeutics, Inc.
Lexington, Massachusetts
We have audited the accompanying consolidated balance sheets of
Critical Therapeutics, Inc. and subsidiary (the
Company) as of December 31, 2007 and 2006, and
the related consolidated statements of operations,
stockholders equity and comprehensive loss, and cash flows
for each of the three years in the period ended
December 31, 2007. Our audits also included the financial
statement schedule listed in the Index at Item 21. These
financial statements and financial statement schedule are the
responsibility of the Companys management. Our
responsibility is to express an opinion on the financial
statements and financial statement schedule based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, such consolidated financial statements present
fairly, in all material respects, the financial position of
Critical Therapeutics, Inc. and subsidiary as of
December 31, 2007 and 2006, and the results of their
operations and their cash flows for each of the three years in
the period ended December 31, 2007, in conformity with
accounting principles generally accepted in the United States.
Also, in our opinion, such financial statement schedule, when
considered in relation to the basic consolidated financial
statements taken as a whole, present fairly, in all material
respects, the information set forth therein.
The accompanying consolidated financial statements have been
prepared assuming that the Company will continue as a going
concern. As discussed in Note 1 to the consolidated
financial statements, the Company has incurred recurring losses
from operations, recurring negative cash flows from operations
and had an accumulated deficit of $191.4 million as of
December 31, 2007. The Company expects to incur substantial
losses for the foreseeable future as a result of research,
development and commercial expenditures. These matters raise
substantial doubt about the Companys ability to continue
as a going concern. Managements plans in regard to these
matters are also described in Note 1. The consolidated
financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
As discussed in Note 2 to the consolidated financial
statements, the Company changed its method of accounting for
stock-based compensation on January 1, 2006 as required by
Statement of Financial Accounting Standards No. 123(R),
Share-Based Payment.
/s/ DELOITTE &
TOUCHE LLP
Boston, Massachusetts
March 27, 2008
F-2
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
|
(In thousands, except share and per share data)
|
|
|
ASSETS:
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
33,828
|
|
|
$
|
48,388
|
|
Accounts receivable, net
|
|
|
1,273
|
|
|
|
877
|
|
Amount due under collaboration agreements
|
|
|
31
|
|
|
|
650
|
|
Short-term investments
|
|
|
|
|
|
|
650
|
|
Inventory
|
|
|
5,599
|
|
|
|
4,048
|
|
Prepaid expenses and other
|
|
|
2,174
|
|
|
|
980
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
42,905
|
|
|
|
55,593
|
|
|
|
|
|
|
|
|
|
|
Fixed assets, net
|
|
|
1,151
|
|
|
|
2,421
|
|
Other assets
|
|
|
868
|
|
|
|
168
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
44,924
|
|
|
$
|
58,182
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY:
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Current portion of long-term debt and capital lease obligations
|
|
$
|
370
|
|
|
$
|
1,012
|
|
Accounts payable
|
|
|
5,283
|
|
|
|
1,049
|
|
Accrued compensation
|
|
|
2,051
|
|
|
|
1,865
|
|
Accrued expenses
|
|
|
5,103
|
|
|
|
2,076
|
|
Current portion of accrued license fees
|
|
|
1,838
|
|
|
|
|
|
Current portion of deferred co-promotion fees
|
|
|
1,880
|
|
|
|
|
|
Deferred collaboration revenue
|
|
|
|
|
|
|
675
|
|
Deferred product revenue
|
|
|
|
|
|
|
1,178
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
16,525
|
|
|
|
7,855
|
|
|
|
|
|
|
|
|
|
|
Long-term debt and capital lease obligations, less current
portion
|
|
|
|
|
|
|
421
|
|
Long-term portion of accrued license fees, less current portion
|
|
|
1,754
|
|
|
|
|
|
Long-term portion of deferred co-promotion fees
|
|
|
9,554
|
|
|
|
|
|
Commitments and contingencies (Note 13)
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Preferred stock, par value $0.001; authorized
5,000,000 shares; no shares issued and outstanding
|
|
|
|
|
|
|
|
|
Common stock, par value $0.001; authorized
90,000,000 shares; issued and outstanding
42,805,348 shares and 42,345,642 shares at
December 31, 2007 and 2006, respectively
|
|
|
43
|
|
|
|
43
|
|
Additional paid-in capital
|
|
|
208,420
|
|
|
|
204,378
|
|
Deferred stock-based compensation
|
|
|
|
|
|
|
(99
|
)
|
Accumulated deficit
|
|
|
(191,372
|
)
|
|
|
(154,399
|
)
|
Accumulated other comprehensive loss
|
|
|
|
|
|
|
(17
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
17,091
|
|
|
|
49,906
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
44,924
|
|
|
$
|
58,182
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-3
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(In thousands, except share and per share data)
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
11,008
|
|
|
$
|
6,647
|
|
|
$
|
387
|
|
Revenue under collaboration and license agreements
|
|
|
1,861
|
|
|
|
6,431
|
|
|
|
5,837
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
12,869
|
|
|
|
13,078
|
|
|
|
6,224
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
4,233
|
|
|
|
2,222
|
|
|
|
514
|
|
Research and development
|
|
|
21,655
|
|
|
|
26,912
|
|
|
|
29,959
|
|
Sales and marketing
|
|
|
12,193
|
|
|
|
18,284
|
|
|
|
13,671
|
|
General and administrative
|
|
|
13,572
|
|
|
|
13,456
|
|
|
|
11,406
|
|
Restructuring charges
|
|
|
|
|
|
|
3,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
51,653
|
|
|
|
64,372
|
|
|
|
55,550
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(38,784
|
)
|
|
|
(51,294
|
)
|
|
|
(49,326
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
2,020
|
|
|
|
2,726
|
|
|
|
2,427
|
|
Interest expense
|
|
|
(209
|
)
|
|
|
(214
|
)
|
|
|
(191
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
1,811
|
|
|
|
2,512
|
|
|
|
2,236
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(36,973
|
)
|
|
$
|
(48,782
|
)
|
|
$
|
(47,090
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
$
|
(0.87
|
)
|
|
$
|
(1.37
|
)
|
|
$
|
(1.61
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted-average common shares outstanding
|
|
|
42,580,884
|
|
|
|
35,529,048
|
|
|
|
29,276,243
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-4
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS EQUITY AND COMPREHENSIVE
LOSS
YEARS ENDED DECEMBER 31, 2007, 2006 AND 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Deferred Stock-
|
|
|
|
|
|
Other
|
|
|
Total
|
|
|
|
|
|
|
Common
|
|
|
Paid-In
|
|
|
Based
|
|
|
Accumulated
|
|
|
Comprehensive
|
|
|
Stockholders
|
|
|
Comprehensive
|
|
|
|
Stock
|
|
|
Capital
|
|
|
Compensation
|
|
|
Deficit
|
|
|
Loss
|
|
|
Equity
|
|
|
Loss
|
|
|
|
(In thousands, except share data)
|
|
|
BALANCE January 1, 2005
|
|
$
|
24
|
|
|
$
|
130,374
|
|
|
$
|
(6,101
|
)
|
|
$
|
(58,527
|
)
|
|
$
|
(362
|
)
|
|
$
|
65,408
|
|
|
|
|
|
Issuance of 96,235 shares of common stock, upon exercise of
options under stock purchase plan
|
|
|
|
|
|
|
158
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
158
|
|
|
|
|
|
Deferred stock-based compensation to non-employees
|
|
|
|
|
|
|
(458
|
)
|
|
|
458
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
2,141
|
|
|
|
|
|
|
|
|
|
|
|
2,141
|
|
|
|
|
|
Reversal of deferred stock based compensation
|
|
|
|
|
|
|
(221
|
)
|
|
|
221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of 9,945,261 shares of common stock and warrants
to purchase 3,480,842 shares of common stock in private
placement, net of $3.1 million in placement fees
|
|
|
10
|
|
|
|
51,352
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51,362
|
|
|
|
|
|
Grant of stock options to non-employees
|
|
|
|
|
|
|
513
|
|
|
|
(513
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(47,090
|
)
|
|
|
|
|
|
|
(47,090
|
)
|
|
$
|
(47,090
|
)
|
Unrealized gain on investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
268
|
|
|
|
268
|
|
|
|
268
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(46,822
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE December 31, 2005
|
|
|
34
|
|
|
|
181,718
|
|
|
|
(3,794
|
)
|
|
|
(105,617
|
)
|
|
|
(94
|
)
|
|
|
72,247
|
|
|
|
|
|
Issuance of 752,241 shares of common stock, upon exercise
of options under stock purchase plan
|
|
|
1
|
|
|
|
613
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
614
|
|
|
|
|
|
Issuance of common stock to employees under stock purchase plan
|
|
|
|
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22
|
|
|
|
|
|
Deferred stock-based compensation to non-employees
|
|
|
|
|
|
|
(904
|
)
|
|
|
904
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
105
|
|
|
|
|
|
|
|
|
|
|
|
105
|
|
|
|
|
|
Reversal of deferred stock based compensation in adopting
SFAS No. 123(R)
|
|
|
|
|
|
|
(2,686
|
)
|
|
|
2,686
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of 7,455,731 shares of common stock and warrants
to purchase 3,727,865 of common stock in a registered offering,
net of $1.5 million in issuance costs
|
|
|
7
|
|
|
|
18,479
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,486
|
|
|
|
|
|
Restricted stock buyback
|
|
|
|
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1
|
)
|
|
|
|
|
Issuance of restricted stock
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
|
|
Stock-based compensation to employees
|
|
|
|
|
|
|
7,137
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,137
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,782
|
)
|
|
|
|
|
|
|
(48,782
|
)
|
|
$
|
(48,782
|
)
|
Unrealized gain on investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
77
|
|
|
|
77
|
|
|
|
77
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(48,705
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE December 31, 2006
|
|
|
43
|
|
|
|
204,378
|
|
|
|
(99
|
)
|
|
|
(154,399
|
)
|
|
|
(17
|
)
|
|
|
49,906
|
|
|
|
|
|
Issuance of 419,557 shares of common stock, upon exercise
of options and vested restricted stock
|
|
|
|
|
|
|
147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
147
|
|
|
|
|
|
Deferred stock-based compensation to non-employees
|
|
|
|
|
|
|
(74
|
)
|
|
|
74
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
|
22
|
|
|
|
|
|
Reversal of deferred stock-based compensation
|
|
|
|
|
|
|
(3
|
)
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock to employees under stock-purchase plan
|
|
|
|
|
|
|
63
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63
|
|
|
|
|
|
Stock-based compensation to employees and non-employees
|
|
|
|
|
|
|
3,909
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,909
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36,973
|
)
|
|
|
|
|
|
|
(36,973
|
)
|
|
$
|
(36,973
|
)
|
Unrealized gain on investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
|
|
|
|
17
|
|
|
|
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(36,956
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE December 31, 2007
|
|
$
|
43
|
|
|
$
|
208,420
|
|
|
$
|
|
|
|
$
|
(191,372
|
)
|
|
$
|
|
|
|
$
|
17,091
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-5
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(In thousands)
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(36,973
|
)
|
|
$
|
(48,782
|
)
|
|
$
|
(47,090
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense
|
|
|
531
|
|
|
|
939
|
|
|
|
800
|
|
Accretion (amortization) of premiums on short-term investments
and other
|
|
|
114
|
|
|
|
(69
|
)
|
|
|
903
|
|
Loss on disposal of fixed assets and other
|
|
|
385
|
|
|
|
86
|
|
|
|
149
|
|
Non-cash restructuring charge
|
|
|
|
|
|
|
1,109
|
|
|
|
|
|
Lease abandonment charge
|
|
|
426
|
|
|
|
|
|
|
|
|
|
Preferred stock received in license agreement, net
|
|
|
(400
|
)
|
|
|
|
|
|
|
|
|
Stock-based compensation expense
|
|
|
3,931
|
|
|
|
6,620
|
|
|
|
2,141
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(396
|
)
|
|
|
140
|
|
|
|
(1,024
|
)
|
Amount due under collaboration agreements
|
|
|
619
|
|
|
|
(445
|
)
|
|
|
(189
|
)
|
Inventory
|
|
|
(1,551
|
)
|
|
|
(2,179
|
)
|
|
|
(1,869
|
)
|
Prepaid expenses and other
|
|
|
(1,194
|
)
|
|
|
1,199
|
|
|
|
(283
|
)
|
Accounts payable
|
|
|
4,234
|
|
|
|
(3,566
|
)
|
|
|
397
|
|
Accrued expenses
|
|
|
2,787
|
|
|
|
(935
|
)
|
|
|
2,135
|
|
Accrued license fees
|
|
|
3,495
|
|
|
|
|
|
|
|
|
|
Deferred collaboration revenue
|
|
|
(675
|
)
|
|
|
(5,031
|
)
|
|
|
(2,837
|
)
|
Deferred product revenue
|
|
|
(1,178
|
)
|
|
|
(529
|
)
|
|
|
1,707
|
|
Deferred co-promotion fees
|
|
|
11,434
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(14,411
|
)
|
|
|
(51,443
|
)
|
|
|
(45,060
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of fixed assets
|
|
|
371
|
|
|
|
|
|
|
|
|
|
Purchases of fixed assets
|
|
|
(17
|
)
|
|
|
(370
|
)
|
|
|
(2,182
|
)
|
Proceeds from sales and maturities of short-term investments
|
|
|
650
|
|
|
|
36,859
|
|
|
|
72,915
|
|
Purchases of investments
|
|
|
(300
|
)
|
|
|
(11,802
|
)
|
|
|
(32,255
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
704
|
|
|
|
24,687
|
|
|
|
38,478
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net proceeds from private placement of common stock
|
|
|
|
|
|
|
18,486
|
|
|
|
51,362
|
|
Proceeds from the issuance of common stock and other
|
|
|
210
|
|
|
|
636
|
|
|
|
158
|
|
Proceeds from long-term debt
|
|
|
|
|
|
|
|
|
|
|
1,300
|
|
Repayments of long-term debt and capital lease obligation
|
|
|
(1,063
|
)
|
|
|
(1,235
|
)
|
|
|
(961
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities
|
|
|
(853
|
)
|
|
|
17,887
|
|
|
|
51,859
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(14,560
|
)
|
|
|
(8,869
|
)
|
|
|
45,277
|
|
Cash and cash equivalents at beginning of year
|
|
|
48,388
|
|
|
|
57,257
|
|
|
|
11,980
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year
|
|
$
|
33,828
|
|
|
$
|
48,388
|
|
|
$
|
57,257
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
120
|
|
|
$
|
221
|
|
|
$
|
172
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed assets acquired under capital lease obligation
|
|
$
|
|
|
|
$
|
|
|
|
$
|
125
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
F-6
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
|
|
(1)
|
Basis of
Presentation
|
Critical Therapeutics, Inc. (the Company) is a
biopharmaceutical company focused on the development and
commercialization of products designed to treat respiratory,
inflammatory and critical care diseases linked to the
bodys inflammatory response. The Company was incorporated
in the state of Delaware on July 14, 2000 under the name
Medicept, Inc. On March 12, 2001, the Company changed its
name from Medicept, Inc. to Critical Therapeutics, Inc. The
Company formed a wholly-owned subsidiary, CTI Securities
Corporation, a Massachusetts corporation, in 2003.
The Company is subject to a number of risks similar to other
companies in the biopharmaceutical industry, including, but not
limited to, risks and uncertainties related to the progress,
timing and success of the Companys regulatory filings,
regulatory approvals and product launches, including ZYFLO
CR®
(zileuton) extended-release tablets (ZYFLO CR); the
Companys ability to develop and maintain the necessary
sales, marketing, distribution and manufacturing capabilities to
commercialize ZYFLO CR; the market acceptance and future sales
of ZYFLO CR; the progress and timing of the Companys drug
development programs and related clinical trials, including
difficulties or delays in the completion of patient enrollment,
data collection or data analysis; the Companys ability to
obtain, maintain and enforce patent and other intellectual
property protection for ZYFLO CR,
ZYFLO®
(zileuton) tablets (ZYFLO), its discoveries and drug
candidates; the Companys ability to successfully enter
into additional strategic co-promotion, collaboration or
licensing transactions on favorable terms, if at all; the
Companys ability to obtain additional financing to conduct
research, development and commercialization activities; and the
Companys compliance with governmental and other
regulations.
Managements
Plans
Since the Companys inception, it has incurred significant
losses each year. As of December 31, 2007, the Company had
an accumulated deficit of $191.4 million. The Company
expects to incur significant losses for the foreseeable future
and it may never achieve profitability. Although the size and
timing of its future operating losses are subject to significant
uncertainty, the Company expects its operating losses to
continue over the next several years as it funds its development
programs, markets and sells ZYFLO CR and prepares for the
potential commercial launch of its product candidates. Since the
Companys inception, it has raised proceeds to fund its
operations through public offerings of common stock, private
placements of equity securities, debt financings, the receipt of
interest income, payments from its collaborators MedImmune and
Beckman Coulter license fees from SetPoint Medical Corporation
(formerly known as Innovative Metabolics, Inc.)
(SetPoint), payments from DEY under its zileuton
co-promotion agreement and revenue from sales of ZYFLO and ZYFLO
CR.
In November 2007, the Companys board of directors
announced that it is in the process of reviewing a range of
strategic alternatives that could result in potential changes to
the Companys current business strategy and future
operations. As part of this process, the Company is considering
alternatives to its current business strategy, and it has
engaged an investment bank to advise it in considering its
potential strategic alternatives. After concluding this review,
it is possible that the Company could determine to pursue one or
more of the strategic alternatives that it is considering or a
variation of one of these alternatives. Pending any decision to
change strategic direction, the Company is continuing its
commercial and development activities in accordance with its
existing business strategy with an increased focus on its cash
position. As a result of this review, the extent of the
Companys future capital requirements is difficult to
assess.
For the year ended December 31, 2007, the Companys
net cash used in operating activities was $14.4 million. If
the Companys existing resources are insufficient to
satisfy its liquidity requirements, either under its current
operating plan or any new operating plan it may adopt, it may
need to raise additional external funds through collaborative
arrangements and public or private financings. Additional
financing may not be available to the Company on acceptable
terms or at all.
F-7
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Going
Concern Assumption
The Company has experienced significant operating losses in each
year since its inception in 2000 and had net losses of
$37.0 million in the year ended December 31, 2007 and
$48.8 million in the year ended December 31, 2006. As
of December 31, 2007, the Company had an accumulated
deficit of approximately $191.4 million. For the year ended
December 31, 2007, it recorded $11.0 million of
revenue from the sale of ZYFLO and ZYFLO CR and has not recorded
revenue from any other product. Management expects that the
Company will continue to incur substantial losses for the
foreseeable future from spending significant amounts to fund the
Companys research, development and commercialization
efforts. These matters raise substantial doubt about the
Companys ability to continue as a going concern and,
therefore, the Company may be unable to realize its assets and
discharge its liabilities in the normal course of business. The
financial statements do not include any adjustments relating to
the recoverability and classification of recorded asset amounts
nor to amounts and classification of liabilities that may be
necessary should the Company be unable to continue as a going
concern.
|
|
(2)
|
Summary
of Significant Accounting Policies
|
Basis
of Presentation
The consolidated financial statements reflect the operations of
the Company and its wholly-owned subsidiary, CTI Securities
Corporation. All intercompany balances and transactions have
been eliminated.
Use of
Estimates
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of
the financial statements, and the reported amounts of revenues
and expenses during the reporting period. Actual results could
differ from those estimates or assumptions. The more significant
estimates reflected in these financial statements include
certain judgments regarding revenue recognition, product
returns, inventory valuation, accrued and prepaid expenses and
valuation of stock-based compensation.
Cash
Equivalents
The Company considers all highly-liquid investments with
original maturities of three months or less when purchased to be
cash equivalents.
Investments
Short-term investments consist primarily of U.S. government
treasury and agency notes, commercial paper, corporate debt
obligations, municipal debt obligations, auction rate securities
and money market funds, each of investment-grade quality, which
have an original maturity date greater than 90 days that
can be sold within one year. These securities are held until
such time as the Company intends to use them to meet the ongoing
liquidity needs to support its operations. These investments are
recorded at fair value and accounted for as available-for-sale
securities. The unrealized gain (loss) during the period is
recorded within accumulated other comprehensive loss unless it
is determined to be other-than-temporary. During the years ended
December 31, 2007, 2006 and 2005, the Company recorded a
net unrealized gain on short-term investments of $17,000,
$77,000 and $268,000, respectively. The original cost of debt
securities is adjusted for amortization of premiums and
accretion of discounts to maturity. The amortization or
accretion is included in interest income (expense).
The unrealized losses as of December 31, 2006 were
primarily caused by interest rate increases. The following table
shows, for the years ended December 31, 2007 and 2006, the
gross unrealized gains and losses and the
F-8
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
fair value of the Companys investments with unrealized
gains and losses that are not deemed to be other-than-temporary,
aggregated by investment category. There were no
available-for-sale securities held as of December 31, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2006
|
|
|
|
Amortized
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Fair
|
|
|
|
Cost
|
|
|
Gains
|
|
|
Losses
|
|
|
Value
|
|
|
|
(In thousands)
|
|
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
12,840
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
12,840
|
|
Commercial paper
|
|
|
32,678
|
|
|
|
1
|
|
|
|
(18
|
)
|
|
|
32,661
|
|
Money market mutual funds
|
|
|
2,887
|
|
|
|
|
|
|
|
|
|
|
|
2,887
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
48,405
|
|
|
|
1
|
|
|
|
(18
|
)
|
|
|
48,388
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities
|
|
|
650
|
|
|
|
|
|
|
|
|
|
|
|
650
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments
|
|
|
650
|
|
|
|
|
|
|
|
|
|
|
|
650
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents and short-term investments
|
|
$
|
49,055
|
|
|
$
|
1
|
|
|
$
|
(18
|
)
|
|
$
|
49,038
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2007, the Company held $300,000 in auction
rate securities with a AAA credit rating upon purchase. In
February 2008, the Company was informed that there was
insufficient demand at auction for these securities. As a
result, this amount is currently not liquid and may not become
liquid unless the Company is able to refinance it. The Company
has classified its $300,000 in auction rate securities as a
long-term
investment and has included the amount in other assets on the
Companys accompanying balance sheet.
Inventory
Inventory is stated at the lower of cost or market with cost
determined under the
first-in,
first-out (FIFO) method. The Company analyzes its inventory
levels quarterly and reserves for inventory that has become
obsolete, inventory that has a cost basis in excess of its
expected net realizable value and inventory in excess of
expected requirements. Expired inventory is disposed of and the
related costs are expensed in the period.
Fixed
Assets
Fixed assets are stated at cost, net of accumulated depreciation
and amortization. Depreciation is computed on a straight-line
basis over estimated useful lives commencing upon the date the
assets are placed in service. Upon retirement or sale, the cost
of the assets disposed of and the related accumulated
depreciation are removed from the accounts and any resulting
gain or loss is included in operating income. Repairs and
maintenance costs are expensed as incurred. The useful lives for
our major asset categories are as follows:
|
|
|
|
|
Asset Description
|
|
Useful Life (Years)
|
|
Furniture and fixtures
|
|
|
7
|
|
Office equipment
|
|
|
5
|
|
Lab equipment
|
|
|
5
|
|
Computer hardware and software
|
|
|
3
|
|
Leasehold improvements are amortized over the shorter of the
useful life of the asset or the lease term.
F-9
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Impairment
of Long-Lived Assets
Long-lived assets and, if and when applicable, certain
identifiable intangibles held and used are reviewed for
impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable. In
performing the review for recoverability, the Company will
estimate the future cash flows expected to result from the use
of the asset and its eventual disposition. If the sum of the
expected future cash flows (undiscounted and without interest
charges) is less than the carrying amount of the asset, an
impairment loss is recognized. Measurement of an impairment loss
for long-lived assets and identifiable intangibles that the
Company expects to hold and use is based on the fair value of
the asset. Assets that are being held for sale are recorded at
the lower of carrying value or fair value less cost to sell. At
December 31, 2007, assets held-for-sale had a fair value of
approximately $167,000 and are included in fixed assets in the
accompanying consolidated balance sheet. In 2007, the Company
accelerated depreciation and recorded an impairment charge of
$275,000 resulting from the Companys decision to cease its
in-house research activities (see Note 16). In 2006, the
Company recorded an impairment charge of approximately $488,000
related to computer and laboratory equipment as a result of its
2006 restructurings (See Note 15).
Research
and Development
Research and development expenses consist of costs incurred in
identifying, developing and testing product candidates. These
expenses consist primarily of salaries and related expenses for
personnel, fees paid to professional service providers for
monitoring and analyzing clinical trials, regulatory costs,
including user fees paid to the FDA, milestone payments to third
parties, costs related to the development of the Companys
NDA for ZYFLO CR, costs of contract research and manufacturing
and the cost of facilities. In addition, research and
development expenses include the cost of the Companys
medical affairs and medical information functions, which educate
physicians on the scientific aspects of its commercial products
and the approved indications, labeling and the costs of
monitoring adverse events. The Company expenses research and
development costs and patent related costs as incurred. Because
of the Companys ability to utilize resources across
several projects, many of its research and development costs are
not tied to any particular project and are allocated among
multiple projects. The Company records direct costs on a
project-by-project
basis. The Company records indirect costs in the aggregate in
support of all research and development. Development costs for
clinical development stage programs tend to be higher than
earlier stage programs due to the costs associated with
conducting clinical trials and large-scale manufacturing. After
FDA approval of a product candidate, manufacturing expenses
associated with a product will be recorded as cost of products
sold rather than as research and development expenses.
Revenue
Recognition and Deferred Revenue
The Company recognizes revenue in accordance with the SEC Staff
Accounting Bulletin No. 101, Revenue Recognition in
Financial Statements (SAB 101) as amended
by SEC Staff Accounting Bulletin No. 104, Revenue
Recognition (SAB 104). Specifically,
revenue is recognized when persuasive evidence of an arrangement
exists, delivery has occurred or services have been rendered,
the price is fixed and determinable and collectibility is
reasonably assured. The Companys revenue is currently
derived from product sales of its commercially marketed
products, ZYFLO and ZYFLO CR and its collaboration and license
agreements. The collaboration and license agreements provide for
various payments, including research and development funding,
license fees, milestone payments and royalties. In addition, the
Companys product sales are subject to various rebates,
discounts and incentives that are customary in the
pharmaceutical industry.
Net
product sales
The Company sells ZYFLO CR and ZYFLO primarily to pharmaceutical
wholesalers, distributors and pharmacies. The Company
commercially launched ZYFLO in October 2005 and ZYFLO CR in
September
F-10
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
2007. The Company authorizes returns for damaged products and
exchanges for expired products in accordance with its return
goods policy and procedures, and has established allowances for
such amounts at the time of sale. The Company is obligated to
accept from customers the return of products that are within six
months of their expiration date or up to 12 months beyond
their expiration date. The Company recognizes revenue from
product sales in accordance with Statement of Financial
Accounting Standards No. 48, Revenue Recognition When
Right of Return Exists, which requires the amount of future
returns to be reasonably estimated at the time of revenue
recognition. The Company recognizes product sales net of
estimated allowances for product returns, estimated rebates in
connection with contracts relating to managed care, Medicaid,
Medicare, and estimated chargebacks from distributors and prompt
payment and other discounts.
The Company establishes allowances for estimated product
returns, rebates and chargebacks primarily based on several
factors, including the actual historical product returns, the
Companys estimate of inventory levels of products in the
distribution channel, the shelf-life of the product shipped,
competitive issues such as new product entrants and other known
changes in sales trends. The Company evaluates this reserve on a
quarterly basis, assessing each of the factors described above,
and adjusts the reserve accordingly.
Prior to the first quarter of 2007, the Company deferred the
recognition of revenue on ZYFLO product shipments to wholesale
distributors until units were dispensed through patient
prescriptions as the Company was unable to reasonably estimate
the amount of future product returns. Units dispensed are not
generally subject to return. In the first quarter of 2007, the
Company began recording revenue upon shipment to third parties,
including wholesalers, distributors and pharmacies, and
providing a reserve for potential returns from these third
parties as sufficient history exists to make such estimates. In
connection with this change in estimate, the Company recorded an
increase in net product sales in the year ended
December 31, 2007 related to the recognition of revenue
from product sales that had been previously deferred, net of an
estimate for remaining product returns. This change in estimate
totaled approximately $953,000 and was reported in the
Companys results for the first quarter of 2007. In
September 2007, the Company launched ZYFLO CR and recorded
$2.3 million in product sales of ZYFLO CR in the second
half of 2007 as a result of the launch. The Company anticipates
that the rate of return for ZYFLO CR will be comparable to the
rate of return used for ZYFLO. As a result, the Company
recognizes revenue for sales of ZYFLO CR upon shipment to third
parties and records a reserve for estimated returns. As of
December 31, 2007, the Companys allowances for ZYFLO
CR and ZYFLO product returns were $177,000 and $696,000,
respectively. Included in the ZYFLO allowance was $605,000
related to product the Company does not expect to be dispensed
by third parties through patient prescriptions in the first
quarter of 2008 as a result of its conversion to ZYFLO CR.
At December 31, 2007, the Companys accounts
receivable balance of $1.3 million was net of allowances of
$29,000. At December 31, 2006, the Companys accounts
receivable balance of $877,000 was net of allowances of $24,000.
Revenue
under collaboration and license agreements
Under the Companys collaboration agreements with MedImmune
and Beckman Coulter, the Company is entitled to receive
non-refundable license fees, milestone payments and other
research and development payments. Payments received are
initially deferred from revenue and subsequently recognized in
the Companys statements of operations when earned. The
Company must make significant estimates in determining the
performance period and periodically review these estimates,
based on joint management committees and other information
shared by the Companys collaborators. The Company
recognizes these revenues over the estimated performance period
as set forth in the contracts based on proportional performance
adjusted from time to time for any delays or acceleration in the
development of the product. For example, a delay or acceleration
of the performance period by the Companys collaborator may
result in further deferral of revenue or the acceleration of
revenue previously deferred. Because MedImmune and
F-11
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Beckman Coulter can each cancel its agreement with the Company,
the Company does not recognize revenues in excess of cumulative
cash collections.
Under the Companys license agreement with SetPoint, the
Company licensed to SetPoint patent rights and know-how relating
to the mechanical and electrical stimulation of the vagus nerve.
Under the agreement with SetPoint, the Company received an
initial license fee of $500,000 in cash junior and SetPoint
preferred stock valued at $500,000 in connection with
SetPoints first financing. However, under its license
agreement with The Feinstein Institute for Medical Research
(formerly known as The North Shore-Long Island Jewish Research
Institute) (The Feinstein Institute), the Company
was obligated to pay to The Feinstein Institute $100,000 of this
cash payment and SetPoint junior preferred stock valued at
$100,000. The Company included in revenue under collaboration
and license agreements for the year ended December 31,
2007, the $1.0 million total initial license fee that the
Company received from SetPoint and included the payments of
$100,000 in cash and SetPoint junior preferred stock valued at
$100,000 that the Company made to The Feinstein Institute in
research and development expenses. These amounts were recorded
in the second quarter of 2007. Under the license agreement,
SetPoint also has agreed to pay the Company $1.0 million,
excluding a $200,000 payment that the Company would be obligated
to pay to The Feinstein Institute, upon full regulatory approval
of a licensed product by the FDA or a foreign counterpart agency
and royalties based on net sales of licensed products and
methods by SetPoint and its affiliates.
Fair
Value of Financial Instruments
The carrying amounts of the Companys financial
instruments, which include cash equivalents, short-term
investments, accounts receivable, accounts payable, long-term
debt, capital lease obligations, and auction rate securities
included in other assets approximate their fair values.
Concentrations
of Credit Risk and Limited Suppliers
SFAS No. 105, Disclosure of Information about
Financial Instruments with Off-Balance-Sheet Risk and Financial
Instruments with Concentrations of Credit Risk, requires
disclosure of any significant off-balance-sheet and credit risk
concentrations. The Company has no off-balance-sheet or
concentrations of credit risk related to foreign exchange
contracts, options contracts or other foreign hedging
arrangements.
The financial instruments that potentially subject the Company
to concentrations of credit risk are cash, cash equivalents,
short-term investments and accounts receivable. The
Companys cash and cash equivalents are maintained with
highly-rated commercial banks and are monitored against the
Companys investment policy, which limits concentrations of
investments in individual securities and issuers.
The Company relies on certain materials used in its development
and manufacturing processes, some of which are procured from a
single source. The Company purchases the zileuton active
pharmaceutical ingredient pursuant to a long-term supply
agreement with one supplier. The failure of a supplier,
including a subcontractor, to deliver on schedule could delay or
interrupt the development or commercialization process and
thereby adversely affect the Companys operating results.
In addition, a disruption in the commercial supply of ZYFLO CR
or a significant increase in the cost of the active
pharmaceutical ingredient from these sources could have a
material adverse effect on the Companys business,
financial position and results of operations.
The Company sells primarily to large national wholesalers, which
in turn, may resell the product to smaller or regional
wholesalers, retail pharmacies or chain drug stores. The
following tables summarize the number of customers that
individually comprise greater than 10% of total billings, some
of which have been recognized as revenue in 2007 and 2006, and
their aggregate percentage of the Companys total billings
for the years ended December 31, 2007, 2006 and 2005 and
the number of customers that comprise more than 10% of total
F-12
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
accounts receivable and their aggregate percentage of the
Companys total accounts receivable at December 31,
2007 and 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31
|
|
|
2007 Billings
|
|
2006 Billings
|
|
2005 Billings
|
|
Company A
|
|
|
39
|
%
|
|
|
40
|
%
|
|
|
26
|
%
|
Company B
|
|
|
37
|
%
|
|
|
37
|
%
|
|
|
29
|
%
|
Company C
|
|
|
19
|
%
|
|
|
18
|
%
|
|
|
30
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
95
|
%
|
|
|
95
|
%
|
|
|
85
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
2007 Accounts
|
|
2006 Accounts
|
|
|
Receivable
|
|
Receivable
|
|
Company A
|
|
|
65
|
%
|
|
|
42
|
%
|
Company B
|
|
|
15
|
%
|
|
|
19
|
%
|
Company C
|
|
|
15
|
%
|
|
|
37
|
%
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
95
|
%
|
|
|
98
|
%
|
|
|
|
|
|
|
|
|
|
Income
Taxes
The Company recognizes deferred tax assets and liabilities for
the expected future tax consequences of events that have
previously been included in either the Companys
consolidated financial statements or tax returns. Deferred tax
assets and liabilities are determined based on the differences
between the financial accounting and tax bases of assets and
liabilities using tax rates expected to be in effect for the
year in which the differences are expected to reverse. A
valuation allowance is provided against net deferred tax assets
where management believes it is more likely than not that the
asset will not be realized. In 2007, the Company adopted FASB
Interpretation No. 48, Accounting for Uncertainty in
Income Taxes an interpretation of FASB Statement
No. 109 (FIN 48), which clarifies the
accounting for uncertainty in income taxes recognized in an
enterprises financial statements in accordance with
FAS 109 and prescribes a recognition threshold and
measurement attribute for the financial statement recognition
and measurement of a tax position taken or expected to be taken
in a tax return. The adoption of FIN 48 did not impact the
Companys financial condition, results of operations, or
cash flows.
Stock-Based
Compensation
Prior to January 1, 2006, the Company accounted for
stock-based awards to employees using the intrinsic-value method
as prescribed by Accounting Principles Board (APB)
Opinion No. 25, Accounting for Stock Issued to Employees
(APB No. 25), and related interpretations
and the disclosure provisions of SFAS 123. Accordingly, no
compensation expense was recorded for options issued to
employees in fixed amounts and with fixed exercise prices at
least equal to the fair market value of the Companys
common stock at the date of grant. Conversely, when the exercise
price for accounting purposes was below fair value of the
Companys common stock on the date of grant, a non-cash
charge to compensation expense was recorded ratably over the
term of the option vesting period in an amount equal to the
difference between the value calculated using the exercise price
and the fair value. The Company issued options prior to
March 19, 2004, the date it filed its initial registration
statement on
Form S-1
(Form S-1),
with the SEC, at values less than deemed fair market value. This
resulted in recording deferred compensation, which has been
recognized into operating expenses over the respective vesting
periods.
F-13
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Effective January 1, 2006, the Company adopted the fair
value recognition provisions of Statement of Financial
Accounting Standards No. 123 (revised 2004), Share-Based
Payments (SFAS No. 123(R)), using the
modified prospective application method, which allows the
Company to recognize compensation cost for granted, but
unvested, awards, new awards and awards modified, repurchased,
or cancelled after the required effective date. In addition, the
Company elected the simplified method of calculating the
Companys APIC Pool as prescribed by
SFAS No. 123(R). Options granted to employees prior to
the date of the initial
Form S-1
filing continue to be accounted for under APB No. 25.
For the year ended December 31, 2005, had employee
compensation expense been determined based on the fair value at
the date of grant consistent with SFAS No. 123, the
Companys pro forma net loss and pro forma net loss per
share would have been as follows:
|
|
|
|
|
|
|
Year Ended
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
|
(In thousands,
|
|
|
|
except loss
|
|
|
|
per share
|
|
|
|
data)
|
|
|
Net loss as reported
|
|
$
|
(47,090
|
)
|
Add: Stock-based compensation expense included in reported net
loss
|
|
|
1,757
|
|
Deduct: Stock-based compensation expense determined under fair
value method
|
|
|
(3,398
|
)
|
|
|
|
|
|
Net loss pro forma
|
|
$
|
(48,731
|
)
|
|
|
|
|
|
Net loss per share (basic and diluted):
|
|
|
|
|
As reported
|
|
$
|
(1.61
|
)
|
Pro forma
|
|
$
|
(1.67
|
)
|
Estimates of the fair value of equity awards will be affected by
the market price of the Companys common stock, as well as
certain assumptions used to value the equity awards. These
assumptions include, but are not limited to, the expected
volatility of the common stock risk free interest rate and the
expected term of options granted. The Company has computed the
impact under SFAS No. 123(R) for options granted and
restricted stock issued using the Black-Scholes option-pricing
model for the years ended December 31, 2007 and 2006. The
Company increased its assumption for the year ended
December 31, 2007 regarding expected volatility to 72%,
from 61% in 2006 based on the Companys actual historical
volatility since its initial public offering. In addition, the
Company decreased its assumption for the year ended
December 31, 2007 regarding the expected life of options to
6.1 years from 6.25 years in prior years. The expected
life of options granted was estimated using the simplified
method calculation as prescribed by SFAS No. 123(R).
The assumptions used and weighted-average information are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Risk-free interest rate
|
|
|
4.4
|
%
|
|
|
4.8
|
%
|
|
|
4.1
|
%
|
Expected dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Expected life
|
|
|
6.1 years
|
|
|
|
6.25 years
|
|
|
|
4 years
|
|
Expected volatility
|
|
|
72
|
%
|
|
|
61
|
%
|
|
|
59
|
%
|
Weighted-average fair value of options granted with exercise
prices equal to fair value
|
|
$
|
1.43
|
|
|
$
|
2.58
|
|
|
$
|
3.26
|
|
All stock-based awards to non-employees are accounted for at
their fair market value in accordance with
SFAS No. 123(R) and Emerging Issues Task Force
No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services,
(EITF No. 96-18).
The Company periodically remeasures the fair value of the
unvested portion of stock-
F-14
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
based awards to non-employees, resulting in charges or credits
to operations in periods when such remeasurement occurs.
Because the Company has accumulated net operating losses as of
December 31, 2007, option exercises may result in a tax
deduction prior to the actual realization of the related tax
benefit. As such, a tax benefit and a credit to additional
paid-in capital for any tax deduction amount in excess of book
compensation expense would not be recognized until the deduction
reduces taxes payable.
Basic
and Diluted Loss per Share
Basic and diluted net loss per common share is calculated by
dividing the net loss by the weighted-average number of common
shares outstanding during the period. Diluted net loss per
common share is the same as basic net loss per common share,
because the effects of potentially dilutive securities are
antidilutive for all periods presented. Antidilutive securities
that are not included in the diluted net loss per share
calculation aggregated 12,838,860, 12,992,960 and 9,809,751 as
of December 31, 2007, 2006 and 2005, respectively. These
antidilutive securities consist of outstanding stock options,
warrants and unvested restricted common stock as of
December 31, 2007, 2006 and 2005.
Comprehensive
Loss
Comprehensive loss is the total of net loss and all other
non-owner changes in equity. The difference between net loss, as
reported in the accompanying consolidated statements of
operations for the years ended December 31, 2007, 2006 and
2005, respectively, and comprehensive loss is the unrealized
gain (loss) on available-for-sale investments for the period.
Total comprehensive loss was $37.0 million,
$48.7 million and $46.8 million for the years ended
December 31, 2007, 2006 and 2005, respectively. The
unrealized gain (loss) on investments is the only component of
accumulated other comprehensive loss in the accompanying
consolidated balance sheets as of December 31, 2006.
Disclosure
about Segments of an Enterprise
The Company follows the provisions of SFAS No. 131,
Disclosures about Segments of an Enterprise and Related
Information. SFAS No. 131 establishes standards
for reporting information regarding operating segments in annual
financial statements and requires selected information for those
segments to be presented in interim financial reports issued to
stockholders. SFAS No. 131 also establishes standards
for related disclosures about products and services and
geographic areas. Operating segments are identified as
components of an enterprise about which separate discrete
financial information is available for evaluation by the chief
operating decision maker, or decision making group, in making
decisions as to how to allocate resources and assess
performance. The Companys chief operating decision maker,
as defined under SFAS No. 131, is the chief executive
officer. The Company believes it operates in one segment. All of
the Companys revenues are generated in the United States
and all assets are located in the United States.
Recent
Accounting Pronouncements
In November 2007, the Financial Accounting Standards
Boards (FASB) Emerging Issues Task Force
(EITF) issued EITF Issue
07-01,
Accounting for Collaborative Arrangements.
EITF 07-01
requires collaborators to present the results of activities for
which they act as the principal on a gross basis and report any
payments received from (made to) other collaborators based on
other applicable GAAP or, in the absence of other applicable
GAAP, based on analogy to authoritative accounting literature or
a reasonable, rational, and consistently applied accounting
policy election. Further, EITF
No. 07-01
clarified that the determination of whether transactions within
a collaborative arrangement are part of a vendor-customer (or
analogous) relationship subject to Issue
01-9,
Accounting for Consideration Given by a Vendor to a
Customer. EITF
F-15
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
No. 07-01
is effective for fiscal years beginning after December 15,
2008. The Company does not expect the adoption of EITF
No. 07-01
to have a material impact on its financial statements and
results of operations.
In June 2007, the EITF issued EITF
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development
Activities
(EITF 07-3).
EITF 07-3
concludes that non-refundable advance payments for future
research and development activities should be deferred and
capitalized until the goods have been delivered or the related
services have been performed. If an entity does not expect the
goods to be delivered or services to be rendered, the
capitalized advance payment should be charged to expense.
EITF 07-3
is effective for fiscal years beginning after December 15,
2007. The initial adjustment to reflect the effect of applying
this EITF as a change in accounting principle would be accounted
for as a cumulative-effect adjustment to retained earnings as of
the beginning of the year of adoption. The Company does not
expect the adoption of EITF
No. 07-03
to have a material impact on its financial statements and
results of operations.
In December 2007, the FASB issued SFAS No. 141(R),
Business Combinations, (SFAS 141(R)).
SFAS 141(R) requires the acquiring entity in a business
combination to record all assets acquired and liabilities
assumed at their respective acquisition-date fair values and
changes other practices under SFAS No. 141,
Business Combinations, some of which could have a
material impact on how an entity accounts for its business
combinations. SFAS 141(R) also requires additional
disclosure of information surrounding a business combination,
such that users of the entitys financial statements can
fully understand the nature and financial impact of the business
combination. SFAS 141(R) is effective for fiscal years
beginning after December 15, 2008 and should be applied
prospectively to business combinations for which the acquisition
date is on or after January 1, 2009. The provisions of
SFAS 141(R) will only impact the Company if it is party to
a business combination after the pronouncement has been adopted.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interest in Consolidated Financial
Statements an amendment of ARB No. 51
(SFAS 160). SFAS 160 requires entities
to report non-controlling minority interests in subsidiaries as
equity in consolidated financial statements. SFAS 160 is
effective for fiscal years beginning on or after
December 15, 2008. SFAS 160 shall be applied
prospectively as of the beginning of the fiscal year in which it
is initially applied, except for presentation and disclosure
requirements, which shall be applied retrospectively for all
periods presented. The Company does not expect the adoption of
SFAS 160 to have a material impact on its financial
statements and results of operations.
In February 2007, the FASB issued Statement No. 159, The
Fair Value Option for Financial Assets and Financial
Liabilities, Including an Amendment of SFAS 115
(FAS 159). FAS 159 permits companies to
choose to measure many financial instruments and certain other
items at fair value. It also establishes presentation and
disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes
for similar types of assets and liabilities. FAS 159
requires companies to provide additional information that will
help investors and other users of financial statements to more
easily understand the effect of a companys choice to use
fair value on its earnings. It also requires entities to display
the fair value of those assets and liabilities for which a
company has chosen to use fair value on the face of the balance
sheet. FAS 159 is effective for fiscal years beginning
after November 15, 2007 and interim periods within those
fiscal years. The Company was required to adopt SFAS 159 on
January 1, 2008. We do not expect the adoption of
SFAS 159 will have a material effect on its consolidated
financial position or results of operations.
In September 2006, the FASB issued Statement No. 157,
Fair Value Measurements (FAS 157).
FAS 157 defines fair value, establishes a framework for
measuring fair value in generally accepted accounting principles
and expands disclosures about fair value measurements. In
February 2008, the FASB issued Staff Position
No. FAS 157-2
(FSP 157-2)
that defers the effective date of applying the provisions of
SFAS 157 to the fair value measurement of nonfinancial
assets and nonfinancial liabilities until fiscal years beginning
after November 15, 2008. The Company was required to adopt
the provisions of SFAS 157 that pertain to
F-16
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
financial assets and liabilities on January 1, 2008. We do
not expect the adoption of SFAS 157 will have a material
impact on its consolidated financial position or results of
operations. The Company is currently evaluating the effect
FSP 157-2
will have on its consolidated financial position and results of
operations.
|
|
(3)
|
Collaboration
Agreements
|
MedImmune
In July 2003, the Company entered into an exclusive license and
collaboration agreement with MedImmune to jointly develop
therapeutic products. Under the agreement, the Company has
granted MedImmune an exclusive, worldwide royalty bearing
license in exchange for a license fee, research funding,
research and development milestone payments and royalties on
product sales. The Company is required to perform certain
research activities under an agreed upon research plan. The
original term of the research plan was expected to be
approximately 41 months, which began on July 30, 2003.
In 2005, the Company changed its estimate of the term covered by
the research plan to 47 months, which resulted in a
decrease in revenue recognized of approximately $237,000 in
2005. During the term of the research plan, the Company has
received research funding from MedImmune based on the number of
full-time equivalents employed by the Company for the purposes
of executing the research plan. No performance is required of
the Company subsequent to the research period. MedImmune will be
responsible for subsequent product development and
commercialization. All payments made to the Company under the
agreement are non-refundable. In 2006, the Company revised its
estimate of remaining total costs to be incurred under the
collaboration agreement with MedImmune. The change in estimate
resulted in an increase in revenue recognized of approximately
$2.0 million in 2006.
In connection with this agreement, the Company received
$12.5 million in upfront license fees and research funding,
which was paid in two installments: $10.0 million in late
2003 and $2.5 million in early 2004. In 2005, the Company
reached a specified milestone and received $1.25 million
from MedImmune. In the event that specified research and
development and commercialization milestones are achieved,
MedImmune will be obligated to make further payments to the
Company. In addition, the Company received approximately
$125,000, $1.0 million and $1.5 million in research
funding from MedImmune in each of the years ended
December 31, 2007, 2006 and 2005, respectively.
Revenue under this arrangement was being recognized under a
proportional performance model. During 2007, 2006 and 2005, the
Company recognized revenue of approximately $400,000,
$6.3 million and $5.7 million, respectively. In 2007,
the Company completed the research term of its agreement with
MedImmune resulting in the full recognition of all revenue that
had been previously deferred from the prior year. As of
December 31, 2006, the Company had deferred revenue of
approximately $275,000 related to this agreement. The deferred
revenue consisted of a portion of the up-front payments,
milestone and research funding received in advance of revenue
recognized under the agreement.
Beckman
Coulter
In January 2005, the Company entered into a license agreement
with Beckman Coulter, under which the Company granted to Beckman
Coulter and its affiliates an exclusive worldwide license to
patent rights and know-how controlled by the Company relating to
the use of high mobility group box protein 1 (HMGB1)
and its antibodies in diagnostics, to evaluate, develop, make,
use and sell a kit or assemblage of reagents for measuring HMGB1
that utilizes one or more monoclonal antibodies to HMGB1
developed by or on behalf of the Company.
In consideration for the license, Beckman Coulter paid the
Company a product evaluation license fee of $250,000 in February
2005. Beckman Coulter also agreed to pay the Company additional
license fees of $400,000 upon the occurrence of the exercise by
Beckman Coulter of its option to undertake formal product
development and $450,000 upon the achievement of the first
commercial sale of a licensed product. Beckman
F-17
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Coulter also agreed to pay the Company royalties based on net
sales of licensed products by Beckman Coulter and its
affiliates. Beckman Coulter has the right to grant sublicenses
under the license subject to the Companys written consent,
which the Company has agreed not to unreasonably withhold.
Beckman Coulter agreed to pay the Company a percentage of any
license fees, milestone payments or royalties actually received
by Beckman Coulter from its sublicensees. Beckman Coulter
exercised its development option under the license agreement in
December 2006 and paid the Company $400,000 in January 2007.
This amount was recognized as revenue under collaboration and
license agreements in 2007. The $400,000 was included in amounts
due under collaboration agreements and revenue deferred under
collaboration agreements at December 31, 2006. No amount
was due under the agreement as of December 31, 2007.
SetPoint
Medical Corporation
In January 2007, the Company entered into an exclusive license
agreement with SetPoint under which the Company licensed to
SetPoint patent rights and know-how relating to the mechanical
and electrical stimulation of the vagus nerve. In May 2007,
under the agreement with SetPoint, the Company received an
initial license fee of $500,000 in cash and SetPoint junior
preferred stock valued at $500,000 in connection with
SetPoints first financing. However, under its license
agreement with The Feinstein Institute, the Company was
obligated to pay The Feinstein Institute $100,000 of this cash
payment and SetPoint junior preferred stock valued at $100,000.
The Company included in revenue under collaboration and license
agreements in 2007 the $1.0 million total license fee that
the Company received from SetPoint and included the payments of
$100,000 in cash and SetPoint junior preferred stock valued at
$100,000 that the Company made to The Feinstein Institute in
research and development expenses. These amounts were recorded
in the second quarter of 2007. Under the license agreement,
SetPoint also has agreed to pay the Company $1.0 million,
excluding a $200,000 payment that the Company would be obligated
to pay The Feinstein Institute, upon full regulatory approval of
a licensed product by the FDA or a foreign counterpart agency
and royalties based on a net sales of licensed products and
methods by SetPoint and its affiliates.
On March 14, 2008, the Company sold 400,000 shares of
junior preferred stock issued to it by SetPoint in May 2007 in
connection with SetPoints first financing for an aggregate
purchase price of $400,000. The Company sold these shares of
junior preferred stock to two investors which had previously
participated in SetPoints first financing. The purchase
price is subject to adjustments if these investors sell or
receive consideration for these shares of junior preferred stock
pursuant to an acquisition of SetPoint prior to February 1,
2009 at a price per share greater than they paid the Company.
Inventory consisted of the following at December 31 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Raw material
|
|
$
|
2,587
|
|
|
$
|
3,662
|
|
Work-in-process
|
|
|
3,062
|
|
|
|
83
|
|
Finished goods
|
|
|
766
|
|
|
|
422
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
6,415
|
|
|
|
4,167
|
|
Less reserve
|
|
|
(816
|
)
|
|
|
(119
|
)
|
|
|
|
|
|
|
|
|
|
Inventory
|
|
$
|
5,599
|
|
|
$
|
4,048
|
|
|
|
|
|
|
|
|
|
|
F-18
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Fixed assets consisted of the following at December 31 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Laboratory equipment
|
|
$
|
759
|
|
|
$
|
1,219
|
|
Computer and office equipment
|
|
|
685
|
|
|
|
689
|
|
Equipment-in-process
|
|
|
2
|
|
|
|
686
|
|
Furniture and fixtures
|
|
|
332
|
|
|
|
488
|
|
Software
|
|
|
464
|
|
|
|
484
|
|
Leasehold improvements
|
|
|
186
|
|
|
|
280
|
|
Assets held under capital lease
|
|
|
32
|
|
|
|
32
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
2,460
|
|
|
|
3,878
|
|
Less accumulated depreciation and amortization
|
|
|
(1,309
|
)
|
|
|
(1,457
|
)
|
|
|
|
|
|
|
|
|
|
Fixed assets net
|
|
$
|
1,151
|
|
|
$
|
2,421
|
|
|
|
|
|
|
|
|
|
|
In 2005, the Company entered into a capital lease arrangement
primarily for computers for its sales force totaling $125,000.
Assets acquired under capital lease agreements were initially
recorded at the present value of the future minimum rental
payments using interest rates appropriate at the inception of
the lease. Property and equipment subject to capital lease
agreements are amortized over the shorter of the life of the
lease or the estimated useful life of the asset. At
December 31, 2007 the Companys net book value related
to its capital leases was $1,000. Included in laboratory
equipment are assets held for sale valued at $167,000.
Depreciation and amortization expense on fixed assets for the
years ended December 31, 2007, 2006 and 2005 was
approximately $531,000, $939,000 and $800,000, respectively. In
2006, the Company adjusted accumulated depreciation by
approximately $750,000 related to assets with a net book value
of $872,000 that the Company deemed impaired as part of its 2006
restructuring and assets retired during the year ended
December 31, 2006. In addition in 2007, the Company
accelerated depreciation and recorded an impairment charge on
fixed assets of $275,000 as a result of its 2007 facility
abandonment.
Accrued expenses consisted of the following at December 31 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Research and development contracts
|
|
$
|
973
|
|
|
$
|
363
|
|
Product returns
|
|
|
873
|
|
|
|
|
|
Marketing and promotion costs
|
|
|
784
|
|
|
|
|
|
Professional fees
|
|
|
624
|
|
|
|
365
|
|
Other
|
|
|
1,849
|
|
|
|
1,348
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
5,103
|
|
|
$
|
2,076
|
|
|
|
|
|
|
|
|
|
|
In June 2002, the Company entered into a loan and security
agreement (the Agreement) with a lender that allowed
the Company to borrow up to $2.25 million to finance the
purchase of equipment and $750,000 to finance leasehold
improvements through June 30, 2003.
F-19
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In June 2004, the Company entered into a modification to the
Agreement. The modification gave the Company the ability to
borrow up to an additional $3.0 million under the Agreement
from July 1, 2004 to December 31, 2004. In 2005, the
Company had additional borrowing capacity up to an amount equal
to the lesser of (i) $3.0 million minus the principal
amount of advances made in 2004 or (ii) $1.3 million.
During 2005, the Company borrowed $1.3 million under the
modified Agreement. No advances were made in 2006 under the
modified Agreement. At December 31, 2007, the Company had
no borrowing capacity available under the modified Agreement or
any other credit agreement. Advances made under the modified
Agreement accrue interest at a rate equal to the prime rate plus
2% per year and are required to be repaid in equal monthly
installments of principal plus interest accrued through the date
of repayment. The repayment terms for advances made under this
modification are between 36 and 42 months. In connection
with the original Agreement, the Company granted the lender a
first priority security interest in substantially all of the
Companys assets, excluding intellectual property, to
secure the Companys obligations under the Agreement.
As of December 31, 2007, there was $369,000 in debt
outstanding under the modified Agreement. The outstanding
borrowings bear interest at a rate of approximately 9.3%.
The repayments of principal and interest are scheduled to be
made as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal
|
|
|
Interest
|
|
|
Total
|
|
|
2008
|
|
$
|
369
|
|
|
$
|
4
|
|
|
$
|
373
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
369
|
|
|
$
|
4
|
|
|
$
|
373
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In January 2008, all outstanding debt under the modified
Agreement was paid in full.
2006
Registered Offering
In October 2006, the Company sold 7,455,731 shares of its
common stock at a price of $2.68 per share, together with
warrants to purchase an additional 3,727,865 shares of
common stock, for a total purchase price of $20.0 million.
The sales were made in a registered offering conducted as a
direct placement through a placement agent. The net proceeds
from the offering were approximately $18.5 million, after
deducting placement agents fees and other offering costs of
approximately $1.5 million.
The warrants issued in connection with the offering have an
exercise price per share of $2.62 per share, with a five-year
life and are fully vested and exercisable from October 26,
2006. The warrants have been included in equity at their fair
value of $5.7 million. The fair value of the warrants was
determined using the Black-Scholes model with the following
assumptions: dividend yield of 0%; estimated volatility of 64%;
risk-free interest rate of 4.51% and a contractual life of five
years. As of December 31, 2007, none of these warrants had
been exercised.
2005
Private Placement
In June 2005, the Company sold 9,945,261 shares of its
common stock at a price of $5.48 per share, together with
warrants to purchase an additional 3,480,842 shares of
common stock, for a total purchase price of $54.5 million
in a private placement. The sales were made to institutional and
other accredited investors. The net proceeds from the private
placement were approximately $51.4 million, after deducting
placement agents fees and other offering costs of approximately
$3.1 million.
In connection with this private placement, the Company issued
and sold an aggregate of 5,200,732 shares of common stock
and warrants to purchase 1,820,257 shares of common stock
to existing stockholders and affiliated entities associated with
four members of the Companys Board of Directors. These
holders paid an
F-20
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
aggregate consideration of $28.5 million and participated
on the same terms as the other purchasers in the private
placement.
The warrants issued in connection with the private placement
have an exercise price per share of $6.58, with a five-year life
and are fully vested and exercisable from June 20, 2005.
The warrants may also be exercised on a cashless basis at the
option of the warrant holder. The warrants have been included in
permanent equity at their fair value of $9.2 million. The
fair value of the warrants was determined using the
Black-Scholes model with the following assumptions: dividend
yield of 0%; estimated volatility of 58%; risk-free interest
rate of 3.65% and a contractual life of five years. As of
December 31, 2007, none of these warrants had been
exercised.
Authorized
Capital
As of December 31, 2007, the authorized capital stock of
the Company consists of 90,000,000 shares of voting common
stock (common stock) with a par value of $0.001 per
share, and 5,000,000 shares of undesignated preferred stock
(preferred stock) with a par value of $0.001 per
share. The common stock holders are entitled to one vote per
share. The rights and preferences of the preferred stock may be
established from time to time by the Companys Board of
Directors.
Restricted
Common Stock Issuances to Non-Employees
The Company has made several grants of restricted common stock
to non-employees since its inception. Many of these restrictions
have lapsed, and therefore, no longer require periodic
remeasurement in our financial statements.
During 2001, the Company issued 27,259 shares of common
stock subject to restrictions and vesting, as partial
consideration for a sponsored research and licensing agreement
with The Feinstein Institute (see Note 12). 25% of the
shares vested immediately, 25% vested in 2001, 25% vested on
July 1, 2006, and the remaining 25%, or 6,815 shares
vested on July 1, 2007.
In 2007, the Company issued 26,700 shares of restricted
stock to a consultant. The fair value at the date of grant was
$24,000. The Company is recording stock-based compensation
ratably over the 24 month vesting period. The Company did
not issue restricted stock to non-employees in 2006 or 2005.
Compensation to date associated with the restricted stock issued
to non-employees has been measured as the difference between the
fair value of the shares and the amount paid by the holder.
Final measurement occurs when performance is complete, which is
assumed to be when the restrictions lapse. The Company recorded
approximately $11,000 in stock-based compensation expense for
the year ended December 31, 2007 related to these shares.
In addition, the Company reduced by approximately $62,000 and
$137,000 its previously recorded deferred stock-based
compensation for years ended December 31, 2006 and 2005,
respectively, related to these shares. These amounts are
included in operating expenses in the accompanying consolidated
statement of operations.
The Company has reserved 12,229,610 shares as of
December 31, 2007 for options outstanding under the
Companys 2004 Stock Incentive Plan and outstanding
warrants.
|
|
(9)
|
Equity
Incentive Plans
|
2006
Stock Purchase Plan
On February 23, 2006, the Companys Board of Directors
adopted, and on April 25, 2006, the Companys
stockholders approved, the Companys 2006 Employee Stock
Purchase Plan (the 2006 Stock Purchase Plan) for the
issuance of up to 400,000 shares of the Companys
common stock to participating employees. The
F-21
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
2006 Stock Purchase Plan is implemented by offering periods with
a duration of six months. Offerings begin each June 1 and
December 1, or the first business day thereafter, and first
commenced June 1, 2006.
On the first day of an offering period, the Company grants to
each eligible employee who has elected to participate in this
plan a purchase right for shares of common stock. The employee
may authorize up to 15% of his or her compensation to be
deducted during the offering period. On the last business day of
the offering period, the employee will be deemed to have
exercised the purchase right, at the applicable purchase price
per share, to the extent of accumulated payroll deductions. The
purchase price per share under this plan is 85% of the lesser of
the closing price per share of the common stock on the NASDAQ
Global Market on the first day of the offering period or the
last business day of the offering period. The 2006 Stock
Purchase Plan may be terminated at any time by the
Companys Board of Directors.
For the years ended December 31, 2007 and 2006, the Company
issued 40,149 and 13,360 shares, respectively, of the
Companys common stock to participating employees.
2004
Stock Incentive Plan
On April 7, 2004, the Companys Board of Directors
adopted, and on May 6, 2004 the Companys stockholders
approved, the 2004 Stock Incentive Plan (the 2004 Stock
Plan) for the issuance of up to 3,680,000 shares of
common stock to be granted through incentive stock options,
nonqualified stock options, and restricted common stock to key
employees, directors, consultants, and vendors of the Company
and its affiliates.
On March 15, 2005, the Companys Board of Directors
adopted, and on June 17, 2005 the Companys
stockholders approved, an amendment to the 2004 Stock Plan to
increase the total number of shares available by 860,000.
On January 1, 2006, the Companys Board of Directors
amended the 2004 Stock Plan to increase the total number of
shares authorized for issuance by an additional 1,333,333,
bringing the total authorized under the 2004 Stock Plan to
5,873,333 shares. At December 31, 2007, the Company
had 1,045,486 shares of common stock available for award
under the 2004 Stock Plan.
The exercise price of stock options is determined by the
compensation committee of the Board of Directors, and may be
equal to or greater than the fair market value of the
Companys common stock on the date the option is granted.
Options generally become exercisable over a period of four years
from the date of grant, and expire 10 years after the grant
date.
2003
Stock Incentive Plan
On September 29, 2003, the Companys Board of
Directors and stockholders adopted the 2003 Stock Incentive Plan
(the 2003 Stock Plan) for the issuance of incentive
stock options, nonqualified stock options, and restricted common
stock to key employees, directors, consultants, and vendors of
the Company and its affiliates. On December 9, 2003, the
Companys Board of Directors amended the 2003 Stock Plan to
increase the total number of shares available to 1,590,666 from
524,000, plus the 284,739 shares available from the 2000
Equity Plan. On June 2, 2004, in connection with the
adoption of the 2004 Stock Plan, the Company transferred the
132,561 remaining shares of common stock available for award in
the 2003 Stock Plan to the 2004 Stock Plan, subject to future
adjustment based upon further cancellations in the 2003 Stock
Plan or the 2000 Equity Plan. Accordingly, there are no shares
of common stock available for award under the 2003 Stock Plan at
December 31, 2007.
Under the terms of the 2003 Stock Plan, the exercise price of
incentive stock options granted was established by the Board of
Directors. The vesting provisions for stock options and
restricted stock were established by the Board of Directors.
F-22
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
2000
Equity Incentive Plan
On July 14, 2000, the Companys Board of Directors and
Company stockholders adopted the 2000 Equity Incentive Plan (the
2000 Equity Plan) for the issuance of incentive
stock options, nonqualified stock options, and restricted common
stock to key employees, directors, consultants, and vendors of
the Company and its affiliates. On October 24, 2002, the
Companys Board of Directors amended the 2000 Equity Plan
to increase the total number of shares available to 4,000,000
from 2,000,000. On September 29, 2003, in connection with
the adoption of the 2003 Stock Plan, the Company transferred the
284,739 remaining shares of common stock available for award in
the 2000 Equity Plan to the 2003 Stock Plan, subject to future
adjustments. Accordingly, there are no shares of common stock
available for award under the 2000 Equity Plan at
December 31, 2007.
Under the terms of the 2000 Equity Plan, the exercise price of
incentive stock options granted must not be less than the fair
market value of the common stock on the date of grant, as
determined by the Board of Directors. The exercise price of
nonqualified stock options and the purchase price of restricted
common stock may be less than the fair market value of the
common stock on the date of grant, as determined by the Board of
Directors, but in no case may the exercise price or purchase
price be less than the statutory minimum. The vesting provisions
for stock options and restricted stock were established by the
Board of Directors.
The following table summarizes stock option activity under all
of the plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
Average
|
|
|
|
Number of
|
|
|
Exercise
|
|
|
|
Shares
|
|
|
Price
|
|
|
Outstanding January 1, 2005
|
|
|
4,500,270
|
|
|
$
|
4.23
|
|
Granted
|
|
|
2,025,900
|
|
|
|
6.70
|
|
Exercised
|
|
|
(96,235
|
)
|
|
|
1.64
|
|
Cancelled
|
|
|
(229,829
|
)
|
|
|
5.54
|
|
|
|
|
|
|
|
|
|
|
Outstanding December 31, 2005
|
|
|
6,200,106
|
|
|
|
5.03
|
|
Granted
|
|
|
3,428,000
|
|
|
|
4.10
|
|
Exercised
|
|
|
(752,241
|
)
|
|
|
0.82
|
|
Cancelled
|
|
|
(3,169,600
|
)
|
|
|
5.81
|
|
|
|
|
|
|
|
|
|
|
Outstanding December 31, 2006
|
|
|
5,706,265
|
|
|
|
4.60
|
|
Granted
|
|
|
1,011,800
|
|
|
|
2.12
|
|
Exercised
|
|
|
(247,386
|
)
|
|
|
1.04
|
|
Cancelled
|
|
|
(1,449,776
|
)
|
|
|
4.84
|
|
|
|
|
|
|
|
|
|
|
Outstanding December 31, 2007
|
|
|
5,020,903
|
|
|
$
|
4.20
|
|
|
|
|
|
|
|
|
|
|
Vested or expected to vest December 31, 2007
|
|
|
4,387,001
|
|
|
$
|
4.25
|
|
|
|
|
|
|
|
|
|
|
Exercisable December 31, 2005
|
|
|
1,809,920
|
|
|
$
|
3.42
|
|
|
|
|
|
|
|
|
|
|
Exercisable December 31, 2006
|
|
|
2,047,280
|
|
|
$
|
4.91
|
|
|
|
|
|
|
|
|
|
|
Exercisable December 31, 2007
|
|
|
2,379,213
|
|
|
$
|
4.85
|
|
|
|
|
|
|
|
|
|
|
F-23
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The options outstanding and exercisable at December 31,
2007 under the plans are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
Exercisable
|
|
|
|
|
|
|
Average
|
|
|
Weighted-
|
|
|
|
|
|
Weighted-
|
|
|
|
Number of
|
|
|
Contractual Life
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
Options
|
|
|
Outstanding
|
|
|
Exercise
|
|
|
Options
|
|
|
Exercise
|
|
Exercise Price
|
|
Outstanding
|
|
|
(In Years)
|
|
|
Price
|
|
|
Exercisable
|
|
|
Price
|
|
|
$0.38-$1.80
|
|
|
617,992
|
|
|
|
7.7
|
|
|
$
|
1.38
|
|
|
|
353,251
|
|
|
$
|
1.09
|
|
$1.88
|
|
|
644,159
|
|
|
|
9.0
|
|
|
$
|
1.88
|
|
|
|
164,049
|
|
|
$
|
1.88
|
|
$1.93-$2.33
|
|
|
503,400
|
|
|
|
9.1
|
|
|
$
|
2.14
|
|
|
|
14,166
|
|
|
$
|
2.11
|
|
$2.38-$3.71
|
|
|
188,900
|
|
|
|
9.2
|
|
|
$
|
2.87
|
|
|
|
23,324
|
|
|
$
|
3.03
|
|
$3.80
|
|
|
817,196
|
|
|
|
8.4
|
|
|
$
|
3.80
|
|
|
|
310,318
|
|
|
$
|
3.80
|
|
$4.31-$5.63
|
|
|
507,144
|
|
|
|
6.5
|
|
|
$
|
5.35
|
|
|
|
419,374
|
|
|
$
|
5.39
|
|
$5.75-5.99
|
|
|
548,750
|
|
|
|
6.5
|
|
|
$
|
5.97
|
|
|
|
348,292
|
|
|
$
|
5.97
|
|
$6.00-$6.83
|
|
|
592,781
|
|
|
|
6.9
|
|
|
$
|
6.55
|
|
|
|
367,636
|
|
|
$
|
6.58
|
|
$6.85-$7.75
|
|
|
528,081
|
|
|
|
7.3
|
|
|
$
|
7.27
|
|
|
|
318,783
|
|
|
$
|
7.31
|
|
$7.78-$8.96
|
|
|
72,500
|
|
|
|
7.2
|
|
|
$
|
8.14
|
|
|
|
60,020
|
|
|
$
|
8.05
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,020,903
|
|
|
|
7.8
|
|
|
$
|
4.20
|
|
|
|
2,379,213
|
|
|
$
|
4.85
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average fair value of stock option grants using the
Black-Scholes option pricing model were $1.43, $2.58 and $3.26
per share in 2007, 2006 and 2005, respectively.
The weighted average remaining contractual term and the
aggregate intrinsic value for options outstanding at
December 31, 2007 were 7.8 years and $84,000,
respectively. The weighted average remaining contractual term
and the aggregate intrinsic value for options vested or expected
to vest at December 31, 2007 were 7.7 years and
$84,000, respectively. The weighted average remaining
contractual term and the aggregate intrinsic value for options
exercisable at December 31, 2007 were 6.9 years and
$83,000, respectively. The total intrinsic value of the options
exercised during the years ended December 31, 2007, 2006
and 2005 was approximately $221,000, $1.4 million and
$567,000, respectively.
During 2007, the Company issued 442,600 shares of
restricted common stock to employees. These shares vest 50% on
the sixth-month anniversary of the grant date and 50% on the
second anniversary of the grant date. During 2006, the Company
issued 556,100 shares of restricted common stock to
employees. These shares vest 50% on the first anniversary of the
grant date and 50% on the second anniversary of the grant date.
In addition, under the restricted stock agreements granted in
2007 and 2006, 50% of all unvested restricted common stock vests
upon a change-of-control event, as defined in the Companys
2004 Stock Incentive Plan. In August 2007, the Companys
Board of Directors approved a share surrender plan in connection
with the employee restricted stock vesting in November and
December 2007. As a result, the Company allowed employees to
surrender 67,929 shares in lieu of their tax obligation.
During 2007 the Company paid $111,000 to various tax authorities
on behalf of its employees who surrendered shares.
F-24
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes the restricted stock activity for
the years ended December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
Grant-
|
|
|
|
|
|
Grant-
|
|
|
|
|
|
Grant-
|
|
|
|
Number of
|
|
|
Date Fair
|
|
|
Number of
|
|
|
Date Fair
|
|
|
Number of
|
|
|
Date Fair
|
|
|
|
Shares
|
|
|
Value
|
|
|
Shares
|
|
|
Value
|
|
|
Shares
|
|
|
Value
|
|
|
Nonvested at beginning of year
|
|
|
556,100
|
|
|
$
|
2.00
|
|
|
|
40,803
|
|
|
$
|
0.38
|
|
|
|
103,613
|
|
|
$
|
0.38
|
|
Granted
|
|
|
442,600
|
|
|
|
1.86
|
|
|
|
556,100
|
|
|
|
2.00
|
|
|
|
|
|
|
|
|
|
Vested
|
|
|
(240,100
|
)
|
|
|
1.47
|
|
|
|
(38,536
|
)
|
|
|
0.38
|
|
|
|
(62,810
|
)
|
|
|
0.38
|
|
Forfeited
|
|
|
(149,350
|
)
|
|
|
1.97
|
|
|
|
(2,267
|
)
|
|
|
0.38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at end of year
|
|
|
609,250
|
|
|
$
|
1.90
|
|
|
|
556,100
|
|
|
$
|
2.00
|
|
|
|
40,803
|
|
|
$
|
0.38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the years ended December 31, 2007, 2006 and 2005 the
Company recorded stock-based compensation of $3.9 million,
$7.2 million and $2.1 million, respectively.
The following table summarizes deferred stock-based compensation
activity for the years ended December 31 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Deferred Compensation Balance Beginning
|
|
$
|
(99
|
)
|
|
$
|
(3,794
|
)
|
|
$
|
(6,101
|
)
|
Employees
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock-based compensation
|
|
|
61
|
|
|
|
500
|
|
|
|
1,757
|
|
Reversal of deferred stock-based compensation
|
|
|
3
|
|
|
|
2,686
|
|
|
|
221
|
|
Non-employees
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
384
|
|
Deferred stock-based compensation
|
|
$
|
(39
|
)
|
|
|
(395
|
)
|
|
|
(513
|
)
|
Re-measure deferred stock-based compensation
|
|
|
74
|
|
|
|
904
|
|
|
|
458
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred Compensation Balance Ending
|
|
$
|
|
|
|
$
|
(99
|
)
|
|
$
|
(3,794
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense for 2007 related to options and restricted
stock issued to employees is included in the accompanying
consolidated statement of operations as research and
development, sales and marketing and general and administrative
expense in the amounts of $1.0 million, $424,000 and
$2.5 million, respectively. Compensation expense for 2006
related to options issued to employees is included in the
accompanying consolidated statement of operations as research
and development, sales and marketing, general and administrative
and restructuring expense in the amounts of $1.7 million,
$1.1 million, $4.2 million and $622,000, respectively.
Compensation expense for 2005 related to these options is
included in the accompanying consolidated statement of
operations as research and development, sales and marketing and
general and administrative expense in the amounts of $489,000,
$119,000 and $1.2 million, respectively.
During 2007, 2006 and 2005, all options issued to employees were
granted at exercise prices equal to fair market value on the
date of grant.
F-25
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes the Companys stock-based
compensation for the years ended December 31 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
Employees
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation adoption of 123(R)
|
|
$
|
3,714
|
|
|
$
|
7,137
|
|
|
$
|
|
|
Stock compensation Intrinsic value awards
|
|
|
61
|
|
|
|
500
|
|
|
|
1,757
|
|
Non-employees
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation adoption of 123(R)
|
|
|
195
|
|
|
|
|
|
|
|
|
|
Stock-based compensation (reversals)
|
|
|
(39
|
)
|
|
|
(395
|
)
|
|
|
384
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,931
|
|
|
$
|
7,242
|
|
|
$
|
2,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2007, 2006 and 2005, the Company granted 50,000, 230,000
and 161,000 options, respectively, to non-employees that are
accounted for in accordance with SFAS No. 123(R) and
the measurement guidance of EITF
No. 96-18.
The fair value of these awards was estimated using the
Black-Scholes option-pricing methodology and was deemed to be
$69,000 for 2007, $369,000 for 2006 and $513,000 for 2005. The
Company adjusted its compensation expense by approximately
$319,000 for the year ended December 31, 2006 and recorded
compensation expense of approximately $145,000 and $520,000
related to these options for the years ended December 31,
2007, and 2005, respectively. Compensation expense in 2007
related to these options is included in the accompanying
consolidated statement of operations as sales and marketing and
general and administrative expense in the amounts of $5,000 and
$154,000, respectively, offset by an adjustment of $14,000 in
research and development expense. The compensation adjustment in
2006 related to these options is included in the accompanying
consolidated statement of operations as an adjustment of
$330,000 in research and development expense offset by
stock-based compensation expense of $11,000 in general and
administrative expense. Compensation expense in 2005 related to
these options is included in the accompanying consolidated
statement of operations as research and development and general
and administrative expense in the amounts of $512,000 and
$8,000, respectively.
As of December 31, 2007, there was $7.3 million of
total unrecognized compensation expense (including the pre Form
S-1 options)
related to unvested share-based compensation awards granted
under the Companys stock incentive plans, which is
expected to be recognized over a weighted-average period of
1.2 years.
The Company anticipates recording additional stock-based
compensation expense of $3.4 million in 2008,
$2.7 million in 2009 and $1.1 million thereafter
relating to the amortization of unrecognized compensation
expense as of December 31, 2007. These anticipated
compensation expenses do not include any adjustment for new or
additional options to purchase common stock granted to employees.
The Company entered into employment agreements with its
officers. These agreements provide for, among other things,
certain severance benefits and acceleration of vesting for stock
options and restricted stock contingent upon future events such
as a change-of-control of the Company. Because the terms in the
employment agreements modified certain provisions of each
officers existing stock awards, a new measurement date was
created for the awards. If a change-of- control occurs, the
Company would be required to record the intrinsic value of any
options or restricted stock that vest on the date of a
change-of-control. The intrinsic value is calculated as the
difference between the fair value of common stock on the date of
remeasurement and the exercise price of the underlying stock
option or the purchase price of restricted stock. As of
December 31, 2007, there were 1.8 million unvested
stock options and restricted stock subject to the modification.
If a change-of-control were to occur and all of these securities
were to vest, $3.6 million would be recorded as stock-based
compensation expense.
F-26
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
(10)
|
Employee
Benefit Plan
|
During 2003, the Company adopted a 401(k) profit sharing plan
(the 401(k) Plan) covering all employees of the
Company who meet certain eligibility requirements. Under the
terms of the 401(k) Plan, the employees may elect to make
tax-deferred contributions through payroll deductions within
statutory and plan limits and the Company may elect to make
matching or voluntary contributions. During 2005, the Company
matched 100% of employee contributions up to a maximum of $1,000
per employee resulting in expense of $122,000. In November 2005,
the Companys Board of Directors amended the 401(k) Plan,
effective January 1, 2006, to provide a matching
contribution to each participant of 50% of the
participants elective deferrals for a plan year up to 6%
of the participants salary up to a maximum of $3,000,
which resulted in expense of $177,000 and $303,000 in 2007 and
2006, respectively.
In July 2006, the FASB issued FIN 48, which clarifies the
accounting for uncertainty in income taxes recognized in an
enterprises financial statements in accordance with
FAS 109 and prescribes a recognition threshold and
measurement attribute for the financial statement recognition
and measurement of a tax position taken or expected to be taken
in a tax return. FIN 48 also provides guidance on
derecognition, classification, interest and penalties,
accounting in interim periods, disclosure, and transition.
The adoption of FIN 48 did not impact the Companys
financial condition, results of operations, or cash flows. At
December 31, 2007, the Company had net deferred tax assets
of $70.5 million. Because of the Companys limited
operating history and the uncertainties surrounding the
Companys ability to generate future taxable income to
realize these assets, management has provided a 100% valuation
allowance against the Companys net deferred tax assets. As
a result, the Company increased its valuation allowance by
$13.4 million for the year ended December 31, 2007.
This change was primarily the result of the increase in the
Companys net operating loss carryforward.
Net operating losses and credits are subject to review and
possible adjustments by the Internal Revenue Service and may be
limited in the event of certain cumulative changes in ownership.
The Tax Reform Act of 1986 contains provisions that may limit
the utilization of net operating loss carryforwards and credits
available to be used in any given year in the event of
significant changes in ownership interest, as defined. The
Company has recorded a full valuation allowance as an offset
against these otherwise recognizable net deferred tax assets due
to the uncertainty surrounding the timing of the realization of
the tax benefit. In the event that the Company determines in the
future that it will be able to realize all or a portion of its
net deferred tax benefit, an adjustment to deferred tax
valuation allowance would increase earnings in the period in
which such a determination is made.
F-27
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Companys deferred tax accounts consisted of the
following at December 31 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating loss carryforward
|
|
$
|
65,007
|
|
|
$
|
52,396
|
|
Research and experimentation credits
|
|
|
1,898
|
|
|
|
2,110
|
|
Depreciation and amortization
|
|
|
1,602
|
|
|
|
673
|
|
Stock-based compensation
|
|
|
1,513
|
|
|
|
822
|
|
Deferred revenue
|
|
|
|
|
|
|
756
|
|
Other
|
|
|
480
|
|
|
|
385
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
70,500
|
|
|
|
57,142
|
|
Less valuation allowance
|
|
|
(70,500
|
)
|
|
|
(57,142
|
)
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
A portion of the net operating loss carry forwards as of
December 31, 2007 include amounts related to stock option
deductions. Under SFAS 123(R), any excess tax benefits from
stock-based compensation are only realized when income taxes
payable is reduced, with the corresponding credit posted to
additional paid-in capital.
As of December 31, 2007, the Company had federal tax net
operating loss carryforwards of approximately $163 million
which expire beginning in 2021 and had state tax net operating
loss carryforwards of approximately $154 million which
expire beginning in 2008. The Company also has research and
experimentation credit carryforwards of approximately
$1.9 million, which begin to expire in 2021. The Company is
subject to taxation by the IRS and by The Commonwealth of
Massachusetts. All years are currently open for examination for
federal return purposes and for years 2002 through 2007 for The
Commonwealth of Massachusetts.
As of December 31, 2007, the total amount of net
unrecognized tax benefit was $202,000, which has been recorded
as a reduction to the deferred tax asset with an offsetting
adjustment to the Companys valuation allowance. Included
in the balance of unrecognized tax benefits at December 31,
2007, are $179,000 of tax benefits that, if recognized, would
affect the effective tax rate.
The Company recognizes interest accrued related to unrecognized
tax benefits and penalties as income tax expense. Related to the
uncertain tax benefits noted above, the Company had no accrual
for interest or penalties on the Companys balance sheets
at December 31, 2006 and at December 31, 2007, and has
not recognized interest
and/or
penalties in the statement of operations for the year ended
December 31, 2007.
|
|
(12)
|
Research
and License Agreements
|
The following is a summary of the Companys significant
research and license agreements:
Abbott
In December 2003, the Company entered into an agreement to
in-license the controlled-release formulation and the injectable
formulation of zileuton from Abbott Laboratories
(Abbott). The Company has the right to commercialize
this product for all clinical indications except for research,
diagnostics, therapeutics and services to humans under age seven
and for cardiovascular and vascular devices. The Company is
obligated to make milestone payments to Abbott for successful
completion of the technology transfer, filing and approval of
the product in the United States and commercialization of the
product. In addition, the Company will make royalty payments to
Abbott based upon sales of the product. The agreement may be
terminated by either party
F-28
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
for cause. The Company may also terminate the agreement at any
time upon 60- days notice to Abbott and payment of a
termination fee. In May 2007, the Company received approval by
the FDA of the new drug application (NDA) for ZYFLO
CR. As a result of the FDA approval, the Company paid
$2.5 million under this agreement in June 2007 and accrued
an additional $2.8 million of which $1.5 million will
be due on each of the first and second anniversary,
respectively, of the FDAs approval of ZYFLO CR. The
amounts due on the first and second anniversary of the
FDAs approval were accrued at the present value of the
total $3.0 million owed, and the accretion of the discount
is included in interest expense. The $2.5 million paid and
the $2.8 million accrued as a result of the FDAs
approval of ZYFLO CR were included in the Companys
research and development expenses in 2007. For the year ended
December 31, 2007, the Company recorded interest expense of
$78,000 related to the accretion of the discount. During 2004,
the Company paid milestone payments of $2.5 million to
Abbott under this agreement. No payments were made during 2005
under the agreement. During 2006, the Company paid milestone
payments of $1.5 million to Abbott related to the filing of
the Companys NDA for ZYFLO CR.
In March 2004, the Company entered into an agreement to
in-license an immediate-release formulation of zileuton from
Abbott. The Company agreed to pay a license fee of $500,000, a
milestone payment and royalties to Abbott based upon sales of
the product. The agreement may be terminated by either party for
cause. The Company may also terminate the agreement at any time
upon
60-days
notice to Abbott. During 2004, the Company paid the $500,000
license fee, and did not pay any milestones under this
agreement. During 2005, the Company paid milestone payments of
$750,000 to Abbott related to the filing of the Companys
supplemental new drug application (sNDA) for the
immediate-release formulation of zileuton. No payments were made
during 2006 and 2007 under the agreement.
SkyePharma
In December 2003, the Company entered into an agreement with a
subsidiary of SkyePharma PLC (SkyePharma), to
in-license the controlled-release technology relating to
zileuton. The Company is required to make milestone payments to
SkyePharma for successful completion of the technology transfer,
filing and approval of the product in the United States and
commercialization of the product. In addition, the Company will
make royalty payments to SkyePharma based upon sales of the
product. The agreement may be terminated by either party for
cause. As a result of the FDAs May 2007 approval of the
Companys NDA for ZYFLO CR, the Company paid $625,000 under
this agreement in June 2007 and accrued an additional $699,000
of which $375,000 will be due on each of the first and second
anniversary, respectively, of the FDAs approval. The
amounts due on the first and second anniversary of the
FDAs approval were accrued at the present value of the
total $750,000 owed, and the accretion of the discount is
included in interest expense. The $625,000 paid and the $699,000
accrued as a result of the FDAs approval were included in
the Companys research and development expenses in 2007.
For the year ended December 31, 2007, the Company recorded
interest expense of $20,000 related to the accretion of the
discount. No payments were made to SkyePharma during 2004 under
the agreement. The Company paid $375,000 and $1.3 million
in 2006 and 2005, respectively, to SkyePharma under this
agreement.
The
Feinstein Institute
In July 2001, the Company entered into a license agreement with
The Feinstein Institute whereby the Company has agreed to
utilize certain of The Feinstein Institutes technology in
its research effort in connection with one of its research
targets, HMGB1. The Company paid and expensed $100,000 to The
Feinstein Institute for the license and may be required to pay
an additional $412,500 if certain research milestones are
achieved. As of December 31, 2007, none of these milestones
had been achieved. In addition, the Company is obligated to pay
royalties to The Feinstein Institute based on product sales. In
the event of no product sales, the Company will be required to
pay minimum annual royalties of $15,000 in years 2008 through
2011 and $75,000 in years 2012 through the expiration of the
patent in 2023. The Company paid the
F-29
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
minimum annual royalty of $15,000 in 2007. The Company also
agreed to pay all patent maintenance costs incurred after
July 1, 2001 and to reimburse The Feinstein Institute up to
$50,000 in patent costs incurred prior to July 1, 2001.
In December 2003, this agreement was amended to redefine the
sublicense fees payable to The Feinstein Institute. In
connection with the amendment, the Company agreed to issue
66,666 shares of common stock having a value of $485,000 to
The Feinstein Institute (see Note 8). As a result of the
collaboration agreement with MedImmune (see Note 3), the
Company incurred an obligation to pay a sublicense fee to The
Feinstein Institute. The Company paid sublicense fees in the
amounts of $100,000, $250,000 and $0 in 2007, 2006, and 2005,
respectively, to The Feinstein Institute. At December 31,
2007 and 2006, $13,000 and $100,000, respectively, was included
in accrued liabilities related to the agreement. As a result of
our collaboration agreement with Beckman Coulter (see
Note 3), the Company paid a sublicense fee of $80,000 to
The Feinstein Institute in 2007.
Also in July 2001, the Company entered into a sponsored research
and license agreement with The Feinstein Institute whereby the
Company committed to $400,000 of research funding over a period
of two years in connection with efforts to identify HMGB1
inhibitors. In July 2003, the Company amended the Agreement to
provide for the Companys contribution of an additional
$600,000 of research funding. During 2006 and 2005, the Company
contributed a total of $100,000 and $200,000, respectively, in
research funding. The Company contributed no research funding in
2007. In connection with obtaining certain licenses from The
Feinstein Institute, the Company issued 27,259 shares of
its common stock (see Note 8), subject to repurchase
restrictions, and may pay up to an additional $300,000 if
certain research milestones are achieved. As of
December 31, 2007, none of these milestones had been
achieved. In addition, the Company is obligated to pay royalties
to The Feinstein Institute based on product sales.
In January 2003, the Company entered into a second sponsored
research and license agreement with The Feinstein Institute
whereby the Company committed to $600,000 of research funding in
the field of alpha-7 cholinergic anti-inflammatory technology
over a period of three years and paid a $175,000 license fee
during 2003. In January 2007, the agreement was amended
resulting in the Company committing an additional $120,000 of
research funding in 2007. During 2007, 2006, and 2005, the
Company contributed a total of $120,000, $150,000, and $250,000,
respectively, in research funding. The Company may be required
to pay an additional $1.5 million in cash and common stock
if certain milestones are achieved as well as royalty payments
based on product sales. In the event of no product sales, the
Company will be required to pay minimum annual royalties of
$100,000 in 2008, which will increase by $50,000 annually to a
maximum of $400,000 in 2014 through the expiration of the patent
in 2023. As of December 31, 2007, none of these milestones
had been achieved.
Patheon
Pharmaceuticals Inc.
In June 2005, the Company entered into a commercial
manufacturing agreement with Patheon Pharmaceuticals Inc.
(Patheon) for the manufacture of commercial supplies
of ZYFLO immediate-release tablets. The Company had previously
contracted with Patheon for the manufacture of ZYFLO for
clinical trials and regulatory review. Under the agreement, the
Company is responsible for supplying the active pharmaceutical
ingredient for ZYFLO to Patheon and Patheon is responsible for
manufacturing the ZYFLO immediate-release tablets and conducting
stability testing. The Company has agreed to purchase at least
50% of its commercial supplies of ZYFLO immediate-release
tablets for sale in the United States from Patheon each year for
the term of the agreement.
The commercial manufacturing agreement has an initial term of
three years beginning on the date that commercial manufacturing
of the ZYFLO immediate-release tablets commences and will
automatically continue for successive one-year periods
thereafter, unless the Company provides Patheon
12-months
prior written notice of termination or Patheon provides the
Company
18-months
prior written notice of termination.
F-30
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
If the Company provides six-months advance notice that it
intends to discontinue commercializing ZYFLO, the Company will
not be required to purchase any additional quantities of ZYFLO
immediate-release tablets, provided that the Company pays
Patheon for a portion of specified fees and expenses associated
with orders previously placed by the Company.
Shasun
Pharma Solutions Ltd.
In February 2005, the Company entered into an agreement with
Rhodia Pharma Solutions Ltd (Rhodia) for the
manufacture of commercial supplies of the zileuton active
pharmaceutical ingredient (API). The Company had
previously contracted with Rhodia to establish and validate a
manufacturing process for the zileuton API and to manufacture
supplies of the zileuton API sufficient for the Companys
clinical trials. Under the new commercial supply agreement,
Rhodia has agreed to complete its validation process at sites
operated by Rhodia and to manufacture the Companys
required commercial supplies of the zileuton API, subject to
specified limitations, through December 31, 2009. In June
2006, Rhodia SA, the parent company of Rhodia, sold the European
assets of its pharmaceutical custom synthesis business to Shasun
Chemicals and Drugs Ltd. As part of this transaction, Rhodia SA
assigned the Companys contract with Rhodia to Shasun.
The agreement will automatically extend for successive one-year
periods after December 31, 2009, unless Shasun provides the
Company with
18-months
prior written notice of cancellation. The Company has the right
to terminate the agreement upon
12-months
prior written notice for any reason, provided that the Company
may not cancel prior to January 1, 2008 for the purpose of
retaining any other company to act as its exclusive supplier of
the API.
Under this agreement, the Company committed to purchase a
minimum amount of API in the fourth quarter of 2006, the first
quarter of 2007 and in the first quarter of 2008. In addition,
we have agreed to purchase certain quantities in 2008 and 2009
with a portion subject to the right of cancellation, with a
termination fee. The API purchased from Shasun currently has a
shelf-life of 36 months and a retest schedule every
24 months. The Company evaluates the need to provide
reserves for contractually committed future purchases of
inventory that may be in excess of forecasted future demand. In
making these assessments, the Company is required to make
judgments as to the future demand for current or committed
inventory levels and as to the expiration dates of its product.
While the purchase commitment for API from Shasun exceeds the
Companys current forecasted demand in 2008, the Company
expects that any excess API purchased in 2007 under its
agreement with Shasun will be used in commercial production
batches in 2008 and 2009 and sold before it requires retesting.
Therefore no reserve for this purchase commitment has been
recorded as of December 31, 2007.
Unless otherwise noted all milestone and other payments are
included in research and development.
|
|
(13)
|
Commitments
and Contingencies
|
From time to time, the Company may have certain contingent
liabilities that arise in the ordinary course of business. The
Company accrues for liabilities when it is probable that future
expenditures will be made and such expenditures can be
reasonably estimated. For all periods presented, the Company is
not a party to any pending material litigation or other material
legal proceedings.
Lease
Obligations
In the third quarter of 2007, the Company ceased its in-house
research activities to focus on the clinical development and
commercialization aspects of its business. The Company recorded
a liability of $360,000 related to a portion of the remaining
obligations under its then operating lease that would expire in
March 2009 at its facility in Lexington, Massachusetts that the
Company ceased to use. The liability recorded was reduced by an
estimated sublease rental income that the Company estimated
could be reasonably obtained for the unused portion of the
facility. In December 2007, the Company adjusted this estimated
sublease income to
F-31
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
reflect the negotiated termination of the Companys
operating lease and the Companys sublease for the
11,298 square feet the Company currently occupies. This
adjustment resulted in a $140,000 reduction to the abandonment
charges. The Company recorded the abandonment charges in the
third and fourth quarter of 2007 in its research and development
expenses. As of December 31, 2007, the remaining obligation
under the operating lease was $214,000, which is included in
accrued expenses.
On January 16, 2008, the Company entered into a sublease
with Microbia. The sublease was entered into in connection with
the Companys negotiated termination of its lease, dated as
of November 18, 2003, between the Company and ARE and the
negotiation of a new lease between ARE and Microbia for the same
premises. Pursuant to the terms of the sublease, the Company is
subleasing from Microbia a portion of the current premises at
60 Westview Street, Lexington, Massachusetts totaling
approximately 11,298 square feet effective March 1,
2008. The sublease has an initial term of 12 months and the
Company has the right to extend this initial term by an
additional six months by giving Microbia written notice of its
intention to do so at least 120 days before the expiration
of the initial term. The sublease provides for rent of $372,834
per year, payable in equal monthly installments of $31,069.50,
and a cash security deposit of $40,000. In addition, the Company
agreed to sell to Microbia specified laboratory equipment and
furniture located at 60 Westview Street.
At December 31, 2007, the Companys then existing
facility lease contained a rent escalation clause that requires
the Company to pay additional rental amounts in the later years
of the lease term. Rent expense for this lease is recognized on
a straight-line basis over the minimum lease term. As such, the
Company has recorded a liability for rent expense in excess of
payments made-to-date. As of December 31, 2007, this
liability totaled $48,000. As a result of the termination of its
existing lease, the Company will record the rent expense in
excess of payments made to date ratably over the remaining two
months of the existing lease.
In addition to its facility, the Company also leases vehicles
and certain computer equipment under operating leases. Rent
expense under its operating leases for the years ended
December 31, 2007, 2006 and 2005 was $1.2 million,
$1.8 million and $1.6 million, respectively. In
addition, in 2005, the Company entered into a capital lease
arrangement primarily for computers for its sales force totaling
$125,000.
The minimum aggregate future obligations under non-cancelable
lease obligations as of December 31, 2007 are as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
Operating
|
|
|
Capital
|
|
Year Ending
|
|
Leases
|
|
|
Leases
|
|
|
2008
|
|
|
668
|
|
|
|
5
|
|
2009
|
|
|
62
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments
|
|
$
|
730
|
|
|
$
|
5
|
|
|
|
|
|
|
|
|
|
|
Less amount representing interest
|
|
|
|
|
|
|
(0
|
)
|
|
|
|
|
|
|
|
|
|
Present value of future minimum lease payments
|
|
|
|
|
|
|
5
|
|
Less current portion
|
|
|
|
|
|
|
(5
|
)
|
|
|
|
|
|
|
|
|
|
Long-term portion
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Founders
Consulting Agreements
In January 2001, as amended in January 2003, each of the
Companys three founders, one of whom was a member of the
Companys Board of Directors, entered into a separate
consulting agreement with the Company in which they contracted
to provide consulting services to the Company. In January 2008,
one of the agreements was extended through December 31,
2009. For the years ended December 31, 2007, 2006 and 2005,
amounts paid under these agreements totaled $36,000, $320,000
and $313,000, respectively.
F-32
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Company has entered into various agreements with third
parties and certain related parties in connection with the
research and development activities of its existing product
candidates as well as discovery efforts on potential new product
candidates. These agreements include costs for research and
development and license agreements that represent the
Companys fixed obligations payable to sponsor research and
minimum royalty payments for licensed patents. These agreements
include costs related to manufacturing, clinical trials and
preclinical studies performed by third parties. The estimated
amount that may be incurred in the future under these agreements
totals approximately $10.1 million as of December 31,
2007. The amount and timing of these commitments may change, as
they are largely dependent on the rate of enrollment in and
timing of the development of the Companys product
candidates. Some of these agreements have been described in more
detail in Note 12.
Consulting
Agreement with Director
On October 25, 2006, the Company entered into a consulting
agreement with a former member of its Board of Directors, under
which the director agreed to provide the Company services
related to commercial sales, marketing and business development
initiatives and other such related projects. Under the
consulting agreement, the Company agreed to pay $1,800 per day
and granted the director an option to purchase
200,000 shares of common stock under the 2004 Stock Plan.
This option had an exercise price of $2.63 per share and would
vest in 36 equal monthly installments commencing on
November 25, 2006. In addition, 50% of the then unvested
options would vest upon a change-of-control or specified
transactions as set forth in the consulting agreement. The fair
value of these stock options on the date of grant using the
Black-Scholes valuation model was $330,000. The fair value of
the stock option was expensed over the vesting period. The
Company periodically remeasured the fair value of the unvested
portion of the stock option, resulting in charges or credits to
operations. During 2007 and 2006, the Company recorded $141,000
and $13,000, respectively, in stock-based compensation expense
related to this option grant. The consulting agreement had a
term of 12 months and automatically renewed on a
month-to-month basis. The Company terminated the consulting
agreement on June 22, 2007. The directors option to
exercise his vested shares of common stock granted under the
agreement expired on September 30, 2007 with no options
being exercised. Through December 31, 2007 and 2006 the
Company paid $14,000 and $65,000, respectively, for consulting
performed under the agreement.
|
|
(14)
|
DEY
Co-Promotion and Marketing Services Agreements
|
On March 13, 2007, the Company entered into an agreement
with DEY, under which the Company and DEY agreed to jointly
promote ZYFLO and ZYFLO CR. Under the co-promotion and marketing
services agreement, the Company granted DEY an exclusive right
and license to promote and detail ZYFLO and ZYFLO CR in the
United States, together with the Company.
Under the co-promotion agreement, DEY paid the Company a
non-refundable upfront payment of $3.0 million in March
2007, a milestone payment of $4.0 million in June 2007
following approval by the FDA of the NDA for ZYFLO CR in May
2007 and a milestone payment of $5.0 million in December
2007 following the commercial launch of ZYFLO CR. Under the
co-promotion agreement, the Company will pay DEY a commission on
quarterly net sales of ZYFLO and ZYFLO CR, after third-party
royalties, in excess of $1.95 million. From the date DEY
begins detailing ZYFLO through the commercial launch of ZYFLO
CR, the commission rate was 70%, following the commercial launch
of ZYFLO CR in September 2007 through December 31, 2010,
the commission rate is 35% and from January 1, 2011 through
December 31, 2013, the commission rate is 20%. The
co-promotion agreement expires on December 31, 2013 and may
be extended upon mutual agreement by the parties.
The Company has deferred the $12.0 million in aggregate
payments received to date and is amortizing these payments over
the term of the agreement. The amortization of the upfront and
milestone payments will be
F-33
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
offset by the co-promotion fees paid to DEY for promoting ZYFLO
and ZYFLO CR. The Company records all ZYFLO and ZYFLO CR sales
generated by the combined sales force and records any
co-promotion fees paid to DEY and the amortization of the
upfront and milestone payments as sales and marketing expenses.
For the year ended December 31, 2007, approximately
$567,000 was amortized from the deferred co-promotion fees
representing the amount earned by DEY during the periods.
On June 25, 2007, the Company entered into a definitive
agreement with DEY to jointly promote DEYs product
PERFOROMISTtm
(formoterol fumarate) Inhalation Solution
(PERFOROMIST), for the treatment of chronic
obstructive pulmonary disease, or COPD. In October 2007, the
Company announced that it commercially launched PERFOROMIST with
DEY. Under the agreement, DEY agreed to pay the Company a
commission on retail sales of PERFOROMIST. The agreement has a
term expiring on December 31, 2013, which may be extended
upon mutual agreement by the parties.
|
|
(15)
|
Restructurings
Charges
|
In May 2006, the Company recorded charges of $499,000 for a
restructuring of its operations that was intended to better
align costs with revenue and operating expectations. The
restructuring charges included $95,000 in general and
administrative expense, $231,000 in research and development
expense and $173,000 in sales and marketing expense.
In connection with the May 2006 restructuring plan, the Company
terminated 27 employees, or approximately 16% of the
Companys workforce at the time, resulting in severance
benefits of $383,000, which were accrued in May 2006. As a
result of terminating these employees, the Company recorded
automobile lease termination fees of $54,000, outplacement
service fees of $39,000 and an impairment charge of $23,000 for
computer equipment for which the future use was currently
uncertain. At December 31, 2006, the Company had $9,000
remaining in accrued expenses related to the May restructuring.
At December 31, 2007, there no remaining accrued expenses
related to the May restructuring.
In October 2006, the Company announced its plan to focus its
resources on the commercialization of ZYFLO CR, for the chronic
treatment of asthma and on the clinical development of the
injectable formulation of zileuton and to significantly reduce
its net cash expenditures through lower spending on its existing
sales force as well as on its discovery and research programs,
resulting in a second restructuring. As part of this new
business strategy, the Company eliminated 60 positions, or
approximately 50% of the Companys workforce at the time.
The headcount reduction included 38 sales and marketing
employees, 17 research and development employees and
5 employees performing general and administrative
functions. The Company substantially completed this
restructuring by December 31, 2006.
In connection with the implementation of its October 2006
restructuring, the Company recorded a charge of
$3.0 million in the fourth quarter of 2006, consisting of
severance benefits of $2.3 million, automobile lease
termination fees of $216,000, outplacement service fees of
$26,000 and an impairment charge and other related charges of
$478,000 for laboratory equipment and computer equipment for
which the future use was currently uncertain. At
December 31, 2006, the Company had $204,000 remaining in
accrued expenses related to the October 2006 restructuring. At
December 31, 2007, there are no remaining accrued expenses
related to the October restructuring.
In addition, in 2006, the Company had $972,000 of severance and
bonus expenses related to the resignation of its former
President and Chief Executive Officer and its former Senior Vice
President of Sales and Marketing, which are not included in the
restructuring charges above. These amounts were paid in December
2006 in accordance with the contractual terms of the severance
and release agreements signed by the individuals.
F-34
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARY
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
(16)
|
Quarterly
Financial Data (Unaudited)
|
The following table summarizes selected unaudited condensed
quarterly financial information for 2007 and 2006. The Company
believes that all adjustments, consisting of normal recurring
adjustments considered necessary for a fair presentation, have
been included in the selected quarterly information (in
thousands, except per share data).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
Quarter Ended
|
|
|
|
December 31,
|
|
|
September 30,
|
|
|
June 30,
|
|
|
March 31,
|
|
|
|
(Unaudited) (In thousands except per share data)
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
2,697
|
|
|
$
|
3,126
|
|
|
$
|
2,291
|
|
|
$
|
2,894
|
|
Revenue under collaboration agreements
|
|
|
31
|
|
|
|
93
|
|
|
|
1,136
|
|
|
|
601
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
2,728
|
|
|
|
3,219
|
|
|
|
3,427
|
|
|
|
3,495
|
|
Cost of goods sold
|
|
|
(1,580
|
)
|
|
|
(1,232
|
)
|
|
|
(680
|
)
|
|
|
(741
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
1,148
|
|
|
|
1,987
|
|
|
|
2,747
|
|
|
|
2,754
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
(13,062
|
)
|
|
|
(10,166
|
)
|
|
|
(16,237
|
)
|
|
|
(7,955
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(11,914
|
)
|
|
|
(8,179
|
)
|
|
|
(13,490
|
)
|
|
|
(5,201
|
)
|
Other income, net
|
|
|
333
|
|
|
|
393
|
|
|
|
534
|
|
|
|
551
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(11,581
|
)
|
|
$
|
(7,786
|
)
|
|
$
|
(12,956
|
)
|
|
$
|
(4,650
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic and diluted
|
|
$
|
(0.27
|
)
|
|
$
|
(0.18
|
)
|
|
$
|
(0.30
|
)
|
|
$
|
(0.11
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
1,937
|
|
|
$
|
1,879
|
|
|
$
|
1,809
|
|
|
$
|
1,022
|
|
Revenue under collaboration agreements
|
|
|
985
|
|
|
|
2,499
|
|
|
|
1,696
|
|
|
|
1,251
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
2,922
|
|
|
|
4,378
|
|
|
|
3,505
|
|
|
|
2,273
|
|
Cost of goods sold
|
|
|
(561
|
)
|
|
|
(267
|
)
|
|
|
(890
|
)
|
|
|
(504
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
2,361
|
|
|
|
4,111
|
|
|
|
2,615
|
|
|
|
1,769
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
(11,694
|
)
|
|
|
(13,549
|
)
|
|
|
(17,679
|
)
|
|
|
(19,228
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(9,333
|
)
|
|
|
(9,438
|
)
|
|
|
(15,064
|
)
|
|
|
(17,459
|
)
|
Other income, net
|
|
|
581
|
|
|
|
558
|
|
|
|
661
|
|
|
|
712
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,752
|
)
|
|
$
|
(8,880
|
)
|
|
$
|
(14,403
|
)
|
|
$
|
(16,747
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic and diluted
|
|
$
|
(0.22
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.42
|
)
|
|
$
|
(0.49
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Because of the method used in calculating per share data, the
quarterly per share data will not necessarily add to the per
share data as computed for the year.
F-35
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
(In thousands)
|
|
|
ASSETS:
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
10,952
|
|
|
$
|
33,828
|
|
Accounts receivable, net
|
|
|
1,520
|
|
|
|
1,273
|
|
Amount due under collaboration agreements
|
|
|
|
|
|
|
31
|
|
Inventory, net
|
|
|
7,760
|
|
|
|
5,599
|
|
Prepaid expenses and other
|
|
|
2,490
|
|
|
|
2,174
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
22,722
|
|
|
|
42,905
|
|
|
|
|
|
|
|
|
|
|
Fixed assets, net
|
|
|
352
|
|
|
|
1,151
|
|
Other assets
|
|
|
284
|
|
|
|
868
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
23,358
|
|
|
$
|
44,924
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY:
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Current portion of long-term debt
|
|
$
|
|
|
|
$
|
370
|
|
Current portion of accrued license fees
|
|
|
1,796
|
|
|
|
1,838
|
|
Current portion of deferred co-promotion fees
|
|
|
1,880
|
|
|
|
1,880
|
|
Accounts payable
|
|
|
4,311
|
|
|
|
5,283
|
|
Accrued expenses
|
|
|
5,325
|
|
|
|
7,154
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
13,312
|
|
|
|
16,525
|
|
|
|
|
|
|
|
|
|
|
Long-term portion of accrued license fees, less current portion
|
|
|
|
|
|
|
1,754
|
|
Long-term portion of deferred co-promotion fees, less current
portion
|
|
|
8,870
|
|
|
|
9,554
|
|
Commitments and contingencies (Note 9)
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Preferred stock, par value $0.001; authorized
5,000,000 shares; no shares issued and outstanding
|
|
|
|
|
|
|
|
|
Common stock, par value $0.001; authorized
90,000,000 shares; issued and outstanding 42,987,848 and
42,805,348 shares at June 30, 2008 and
December 31, 2007, respectively
|
|
|
43
|
|
|
|
43
|
|
Additional paid-in capital
|
|
|
209,919
|
|
|
|
208,420
|
|
Accumulated deficit
|
|
|
(208,770
|
)
|
|
|
(191,372
|
)
|
Accumulated other comprehensive loss
|
|
|
(16
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
1,176
|
|
|
|
17,091
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
23,358
|
|
|
$
|
44,924
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
F-36
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
(In thousands except share and per share data)
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
7,227
|
|
|
$
|
5,185
|
|
Revenue under collaboration and license agreements
|
|
|
|
|
|
|
1,737
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
7,227
|
|
|
|
6,922
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
4,657
|
|
|
|
1,421
|
|
Research and development
|
|
|
6,927
|
|
|
|
13,022
|
|
Sales and marketing
|
|
|
6,031
|
|
|
|
4,582
|
|
General and administrative
|
|
|
6,010
|
|
|
|
6,588
|
|
Restructuring charges
|
|
|
1,204
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
24,829
|
|
|
|
25,613
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(17,602
|
)
|
|
|
(18,691
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
289
|
|
|
|
1,154
|
|
Interest expense
|
|
|
(85
|
)
|
|
|
(69
|
)
|
|
|
|
|
|
|
|
|
|
Total other income
|
|
|
204
|
|
|
|
1,085
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(17,398
|
)
|
|
$
|
(17,606
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
$
|
(0.41
|
)
|
|
$
|
(0.41
|
)
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted-average common shares outstanding
|
|
|
42,857,558
|
|
|
|
42,513,852
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
F-37
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
(In thousands)
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(17,398
|
)
|
|
$
|
(17,606
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense
|
|
|
235
|
|
|
|
335
|
|
Amortization of premiums on short-term investments and other
|
|
|
79
|
|
|
|
4
|
|
(Gain) loss on sale of fixed assets
|
|
|
(106
|
)
|
|
|
18
|
|
Impairment charge on fixed asset
|
|
|
393
|
|
|
|
|
|
Preferred stock received in license agreement, net
|
|
|
|
|
|
|
(400
|
)
|
Stock-based compensation expense
|
|
|
1,499
|
|
|
|
2,038
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(247
|
)
|
|
|
(137
|
)
|
Amount due under collaboration agreements
|
|
|
31
|
|
|
|
619
|
|
Inventory
|
|
|
(2,161
|
)
|
|
|
(337
|
)
|
Prepaid expenses and other assets
|
|
|
(148
|
)
|
|
|
(1,211
|
)
|
Accounts payable
|
|
|
(972
|
)
|
|
|
342
|
|
Accrued expenses
|
|
|
(1,829
|
)
|
|
|
(776
|
)
|
Accrued license fees
|
|
|
(1,875
|
)
|
|
|
3,495
|
|
Deferred collaboration revenue and fees
|
|
|
|
|
|
|
(675
|
)
|
Deferred product revenue
|
|
|
|
|
|
|
(1,178
|
)
|
Deferred co-promotion fees
|
|
|
(684
|
)
|
|
|
6,943
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(23,183
|
)
|
|
|
(8,526
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Proceeds from sale of investment
|
|
|
400
|
|
|
|
|
|
Proceeds from sale of fixed assets
|
|
|
278
|
|
|
|
212
|
|
Purchases of fixed assets
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
677
|
|
|
|
212
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options and other
|
|
|
|
|
|
|
295
|
|
Repayments of long-term debt and capital lease obligations
|
|
|
(370
|
)
|
|
|
(556
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in financing activities
|
|
|
(370
|
)
|
|
|
(261
|
)
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents
|
|
|
(22,876
|
)
|
|
|
(8,575
|
)
|
Cash and cash equivalents at beginning of period
|
|
|
33,828
|
|
|
|
48,388
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
10,952
|
|
|
$
|
39,813
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
Cash paid during the period for:
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
10
|
|
|
$
|
74
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
F-38
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
(Unaudited)
|
|
(1)
|
Basis of
Presentation
|
The accompanying unaudited condensed consolidated financial
statements include the accounts of Critical Therapeutics, Inc.
and its subsidiaries (collectively, the Company),
and have been prepared in accordance with accounting principles
generally accepted in the United States of America for interim
financial information and with Article 10 of
Regulation S-X.
Accordingly, they do not include all of the information and
footnotes required by accounting principles generally accepted
in the United States of America for complete financial
statements. The Company believes that all adjustments,
consisting of normal recurring adjustments, considered necessary
for a fair presentation, have been included.
Operating results for the six-month periods ended June 30,
2008 and 2007 are not necessarily indicative of the results for
the full year.
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States of
America requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of
the financial statements, and the reported amounts of revenues
and expenses during the reporting period. Actual results could
differ from those estimates or assumptions. The more significant
estimates reflected in these financial statements include
certain judgments regarding revenue recognition, product
returns, inventory, accrued and prepaid expenses, short-term
investments, stock-based compensation and income taxes.
Managements
Plans and Proposed Transaction
In November 2007, the Companys board of directors
announced that it was reviewing a range of strategic
alternatives that could result in potential changes to the
Companys current business strategy and future operations.
As a result of its strategic alternatives process, on
May 1, 2008, the Company and Neptune Acquisition Corp., a
wholly owned subsidiary of the Company (the Transitory
Subsidiary), entered into an Agreement and Plan of Merger
(the Merger Agreement) with Cornerstone BioPharma
Holdings, Inc. (Cornerstone). Under the Merger
Agreement, the Transitory Subsidiary will be merged with and
into Cornerstone (the Merger), with Cornerstone
continuing after the Merger as the surviving corporation and a
wholly owned subsidiary of the Company. If the Merger is
completed, at the effective time of the Merger, all outstanding
shares of Cornerstones common stock will be converted into
and exchanged for shares of the Companys common stock, and
all outstanding options, whether vested or unvested, and all
outstanding warrants to purchase Cornerstones common stock
will be assumed by the Company and become options and warrants
to purchase the Companys common stock. The Merger
Agreement provides that in the Merger the Company will issue to
Cornerstone stockholders, and assume Cornerstone options and
warrants that will represent, an aggregate of approximately
101.5 million shares of the Companys common stock,
subject to adjustment as a result of a contemplated reverse
stock split of the Companys common stock to occur in
connection with the Merger. Immediately following the effective
time of the Merger, Cornerstones stockholders will own
approximately 70 percent, and the Companys current
stockholders will own approximately 30 percent, of the
Companys common stock, after giving effect to shares
issuable pursuant to Cornerstones outstanding options and
warrants, but without giving effect to any shares issuable
pursuant to the Companys outstanding options and warrants.
The exact exchange ratio per share of Cornerstones common
stock will be based in part on the number of shares of
Cornerstones common stock outstanding immediately prior to
the effective time of the Merger and will not be calculated
until that time.
The consummation of the Merger is subject to a number of closing
conditions, including the approval of the Companys
stockholders, approval by NASDAQ of the Companys
application for re-listing of its common stock in connection
with the Merger, the continued availability of the
Companys products and other customary closing conditions.
The Company is targeting a closing of the transaction in the
fourth quarter of 2008.
F-39
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Immediately prior to the effective time of the Merger, the
Company has agreed to effect a reverse stock split of its common
stock whereby each issued and outstanding share of its common
stock will be reclassified and combined into a fractional number
of shares of common stock. The reverse stock split ratio is to
be mutually agreed upon by the Company and Cornerstone. The
reverse stock split is necessary so that, as of the effective
time of the Merger, the Company will satisfy the minimum bid
price requirement pursuant to NASDAQs initial listing
standards.
The Merger Agreement provides for the payment of a termination
fee of $1.0 million by each of the Company and Cornerstone
to the other party in specified circumstances in connection with
the termination of the Merger Agreement. In addition, in
specified circumstances in connection with termination of the
Merger Agreement, the Company has agreed to reimburse
Cornerstone for up to $150,000 in expenses and Cornerstone has
agreed to reimburse the Company for up to $100,000 in expenses.
Going
Concern Assumption
The Company has experienced significant operating losses in each
year since its inception in 2000, including net losses of
$37.0 million in the year ended December 31, 2007 and
$48.8 million in the year ended December 31, 2006. The
Company had net losses of $17.4 million in the six months
ended June 30, 2008 and $17.6 million in the six
months ended June 30, 2007. As of June 30, 2008, the
Company had an accumulated deficit of approximately
$209 million. For the year ended December 31, 2007 and
the six months ended June 30, 2008, the Company recorded
$11.0 million and $7.2 million, respectively, of
revenue from the sale of
ZYFLO®
(zileuton) tablets (ZYFLO) and ZYFLO
CR®
(zileuton) extended-release tablets (ZYFLO CR) and
has not recorded revenue from any other product.
Although the size and timing of its future operating losses are
subject to significant uncertainty, the Company expects its
operating losses to continue over the next several years as it
funds its development programs, markets and sells ZYFLO CR and
prepares for the potential commercial launch of its product
candidates and may never achieve profitability. Since the
Companys inception, it has raised proceeds to fund its
operations through public offerings of common stock, private
placements of equity securities, debt financings, the receipt of
interest income, payments from its collaborators, MedImmune,
Inc. (MedImmune) and Beckman Coulter, Inc.
(Beckman Coulter), license fees from SetPoint
Medical Corporation (formerly known as Innovative Metabolics,
Inc.) (SetPoint), payments from Dey, L.P., a wholly
owned subsidiary of Mylan, Inc. (DEY), under its
zileuton co-promotion agreement and revenue from sales of ZYFLO
CR and ZYFLO.
For the six months ended June 30, 2008, the Companys
net cash used in operating activities was $23.2 million.
Based on its current operating plans, the Company believes that
its available cash and cash equivalents and anticipated cash
received from product sales will not be sufficient to fund the
Companys operations for the next twelve months. If the
Companys existing resources are insufficient to satisfy
its liquidity requirements, either under its current operating
plan or any new operating plan it may adopt, it may need to
raise additional external funds through collaborative
arrangements and public or private financings. Additional
financing may not be available to the Company on acceptable
terms or at all.
These matters raise substantial doubt about the Companys
ability to continue as a going concern and, therefore, the
Company may be unable to realize its assets and discharge its
liabilities in the normal course of business. The financial
statements do not include any adjustments relating to the
recoverability and classification of recorded asset amounts nor
to amounts and classification of liabilities that may be
necessary should the Company be unable to continue as a going
concern.
F-40
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Recent
Accounting Pronouncements
In November 2007, the Financial Accounting Standards
Boards (FASB) Emerging Issues Task Force
(EITF) issued EITF Issue
No. 07-01,
Accounting for Collaborative Arrangements
(EITF 07-01).
EITF 07-01
requires collaborators to present the results of activities for
which they act as the principal on a gross basis and report any
payments received from (made to) other collaborators based on
other applicable generally accepted accounting principles in the
United States of America (GAAP) or, in the absence
of other applicable GAAP, based on analogy to authoritative
accounting literature or a reasonable, rational and consistently
applied accounting policy election. Further,
EITF 07-01
clarified that the determination of whether transactions within
a collaborative arrangement are part of a vendor-customer or
analogous relationship subject to EITF Issue
No. 01-9,
Accounting for Consideration Given by a Vendor to a
Customer.
EITF 07-01
is effective for fiscal years beginning after December 15,
2008. The Company does not expect the adoption of
EITF 07-01
to have a material impact on its financial statements and
results of operations.
In June 2007, the EITF issued EITF Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development
Activities
(EITF 07-3).
EITF 07-3
concludes that non-refundable advance payments for future
research and development activities should be deferred and
capitalized until the goods have been delivered or the related
services have been performed. If an entity does not expect the
goods to be delivered or the services to be rendered, the
capitalized advance payment should be charged to expense.
EITF 07-3
is effective for fiscal years beginning after December 15,
2007. The initial adjustment to reflect the effect of applying
this EITF as a change in accounting principle would be accounted
for as a cumulative-effect adjustment to retained earnings as of
the beginning of the year of adoption. The adoption of
EITF 07-03
did not have a material impact on the Companys financial
statements and results of operations.
In May 2008, the FASB issued Statement of Financial Accounting
Standards (SFAS) No. 162, The
Hierarchy of Generally Accepted
Accounting Principles (SFAS 162).
SFAS 162 identifies the sources of accounting principles
and the framework for selecting the principles to be used in the
preparation of financial statements of nongovernmental entities
that are presented in conformity with GAAP (the GAAP
hierarchy). SFAS 162 makes the GAAP hierarchy
explicitly and directly applicable to preparers of financial
statements, a step that recognizes preparers
responsibilities for selecting the accounting principles for
their financial statements, and sets the stage for making the
framework of the FASB Concept Statements fully authoritative.
The effective date for SFAS 162 is 60 days following
the SECs approval of the Public Company Accounting
Oversight Boards related amendments to remove the GAAP
hierarchy from auditing standards, where it has resided for some
time. The Company does not expect the adoption of SFAS 162
to have a material impact on its financial statements and
results of operations.
In April 2008, the FASB issued FASB Staff Position Financial
Accounting Standard
142-3,
Determination of the Useful
Life of Intangible Assets (FSP
FAS 142-3).
FSP
FAS 142-3
amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful
life of a recognized intangible asset under
SFAS No. 142, Goodwill and Other
Intangible Assets (SFAS 142). In
developing assumptions about renewal or extension, FSP
FAS 142-3
requires an entity to consider its own historical experience or,
if it has no experience, market participant assumptions,
adjusted for the entity-specific factors in paragraph 11 of
SFAS 142. FSP
FAS 142-3
expands the disclosure requirements of SFAS 142 and is
effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods
within those fiscal years, with early adoption prohibited. The
guidance for determining the useful life of a recognized
intangible asset must be applied prospectively to intangible
assets acquired after the effective date. The disclosure
requirements must be applied prospectively to all intangible
assets recognized as of, and subsequent to, the effective date.
The Company does not expect the adoption of FSP
FAS 142-3
to have a material impact on its financial statements and
results of operations.
F-41
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
In December 2007, the FASB issued SFAS No. 141(R),
Business Combinations (SFAS 141(R)).
SFAS 141(R) requires the acquiring entity in a business
combination to record all assets acquired and liabilities
assumed at their respective acquisition-date fair values and
changes other practices under SFAS No. 141,
Business Combinations, some of which could have a
material impact on how an entity accounts for its business
combinations. SFAS 141(R) also requires additional
disclosure of information surrounding a business combination,
such that users of the entitys financial statements can
fully understand the nature and financial impact of the business
combination. SFAS 141(R) is effective for fiscal years
beginning after December 15, 2008 and is applied
prospectively to business combinations for which the acquisition
date is on or after January 1, 2009. The provisions of
SFAS 141(R) will only impact the Company if it is party to
a business combination after the pronouncement has been adopted.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interest in Consolidated Financial
Statements an amendment of ARB No. 51
(SFAS 160). SFAS 160 requires entities
to report non-controlling minority interests in subsidiaries as
equity in consolidated financial statements. SFAS 160 is
effective for fiscal years beginning on or after
December 15, 2008. SFAS 160 is applied prospectively
as of the beginning of the fiscal year in which it is initially
applied, except for presentation and disclosure requirements,
which are applied retrospectively for all periods presented. The
Company does not expect the adoption of SFAS 160 to have a
material impact on its financial statements and results of
operations.
In February 2007, the FASB issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial
Liabilities, Including an Amendment of SFAS 115
(SFAS 159). SFAS 159 permits companies to
choose to measure many financial instruments and certain other
items at fair value. It also establishes presentation and
disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes
for similar types of assets and liabilities. SFAS 159
requires companies to provide additional information that will
help investors and other users of financial statements to more
easily understand the effect of a companys choice to use
fair value on its earnings. It also requires entities to display
the fair value of those assets and liabilities for which a
company has chosen to use fair value on the face of the balance
sheet. SFAS 159 is effective for fiscal years beginning
after November 15, 2007 and interim periods within those
fiscal years. The Company was required to adopt SFAS 159 on
January 1, 2008. The adoption of SFAS 159 did not have
a material impact on the Companys financial statements and
results of operations, as it elected not to measure any
financial assets or liabilities at fair value.
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements (SFAS 157).
SFAS 157 defines fair value, establishes a framework for
measuring fair value in generally accepted accounting principles
and expands disclosures about fair value measurements. In
February 2008, the FASB issued Staff Position
No. FAS 157-2
(FSP 157-2)
that defers the effective date of applying the provisions of
SFAS 157 to the fair value measurement of nonfinancial
assets and nonfinancial liabilities until fiscal years beginning
after November 15, 2008. The Company was required to adopt
the provisions of SFAS 157 that pertain to financial assets
and liabilities on January 1, 2008 and has included the now
expanded disclosures in Note 3. The Company is currently
evaluating the effect
FSP 157-2
will have on its financial statements and results of operations.
Revenue
Recognition
The Company recognizes revenue in accordance with the SEC Staff
Accounting Bulletin No. 101, Revenue Recognition in
Financial Statements (SAB 101), as amended
by SEC Staff Accounting Bulletin No. 104, Revenue
Recognition (SAB 104). Specifically,
revenue is recognized when persuasive evidence of an arrangement
exists, delivery has occurred or services have been rendered,
the price is fixed and determinable and collectibility is
reasonably assured. The Companys revenue is currently
derived from product sales of its commercially marketed
products, ZYFLO CR and ZYFLO, and its collaboration and license
agreements. The
F-42
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
collaboration and license agreements provide for various
payments, including research and development funding, license
fees, milestone payments and royalties. In addition, the
Companys product sales are subject to various rebates,
discounts and incentives that are customary in the
pharmaceutical industry.
Net
product sales
The Company sells ZYFLO CR and ZYFLO primarily to pharmaceutical
wholesalers, distributors and pharmacies. The Company
commercially launched ZYFLO in October 2005 and ZYFLO CR in
September 2007. The Company authorizes returns for damaged
products and exchanges for expired products in accordance with
its return goods policy and procedures, and has established
allowances for such amounts at the time of sale. The Company is
obligated to accept from customers the return of products that
are within six months of their expiration date or up to
12 months beyond their expiration date. The Company
recognizes revenue from product sales in accordance with
SFAS No. 48, Revenue Recognition When Right of
Return Exists, which requires the amount of future returns
to be reasonably estimated at the time of revenue recognition.
The Company recognizes product sales net of estimated allowances
for product returns, estimated rebates in connection with
contracts relating to managed care, Medicaid, Medicare, and
estimated chargebacks from distributors and prompt payment and
other discounts.
The Company establishes allowances for estimated product
returns, rebates and chargebacks primarily based on several
factors, including the actual historical product returns, the
Companys estimate of inventory levels of the
Companys products in the distribution channel, the
shelf-life of the product shipped, competitive issues such as
new product entrants and other known changes in sales trends.
The Company evaluates this reserve on a quarterly basis,
assessing each of the factors described above, and adjusts the
reserve accordingly.
The Companys estimates of product returns, rebates and
chargebacks require managements subjective and complex
judgment due to the need to make estimates about matters that
are inherently uncertain. If actual future payments for returns,
rebates, chargebacks and other discounts exceed the estimates
the Company made at the time of sale, its financial position,
results of operations and cash flows would be negatively
impacted.
As of June 30, 2008 and 2007, the Companys allowances
for ZYFLO CR and ZYFLO product returns were $119,000 and
$153,000, respectively. Prior to the first quarter of 2007, the
Company deferred the recognition of revenue on ZYFLO product
shipments to wholesale distributors and pharmacies until units
were dispensed through patient prescriptions, as the Company was
unable to reasonably estimate the amount of future product
returns. Units dispensed are not generally subject to return. In
the first quarter of 2007, the Company began recording revenue
upon shipment to third parties, including wholesalers,
distributors and pharmacies, and providing a reserve for
potential returns from these third parties as sufficient history
existed to make such estimates. In connection with this change
in estimate, the Company recorded an increase in net product
sales in the first quarter of 2007 related to the recognition of
revenue from product sales that had been previously deferred,
net of an estimate for remaining product returns. This change in
estimate totaled approximately $953,000. The Company anticipates
that the rate of return for ZYFLO CR will be comparable to the
historical rate of return used for ZYFLO. As a result, the
Company recognizes revenue for sales of ZYFLO CR upon shipment
to third parties and records a reserve for potential returns.
Revenue
under collaboration and license agreements
Under the Companys collaboration agreements with MedImmune
and Beckman Coulter, the Company is entitled to receive
non-refundable license fees, milestone payments and other
research and development payments. Payments received are
initially deferred from revenue and subsequently recognized in
the Companys statements of operations when earned. The
Company must make significant estimates in determining the
performance period and periodically review these estimates,
based on joint management committees and other information
shared by the Companys collaborators. The Company
recognizes these revenues over the estimated performance period
as set forth in the contracts based on proportional performance
adjusted from time to time for any delays or acceleration in the
development of the product. For
F-43
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
example, a delay or acceleration of the performance period by
the Companys collaborator may result in further deferral
of revenue or the acceleration of revenue previously deferred.
Because MedImmune and Beckman Coulter can each cancel its
agreement with the Company, the Company does not recognize
revenues in excess of cumulative cash collections.
Under the Companys license agreement with SetPoint, the
Company licensed to SetPoint patent rights and know-how relating
to the mechanical and electrical stimulation of the vagus nerve.
Under the agreement with SetPoint , the Company received an
initial license fee of $500,000 in cash and SetPoint junior
preferred stock valued at $500,000 in connection with
SetPoints first financing. However, under its license
agreement with The Feinstein Institute for Medical Research
(formerly known as The North Shore-Long Island Jewish Research
Institute (The Feinstein Institute), the Company was
obligated to pay The Feinstein Institute $100,000 of this cash
payment and SetPoint junior preferred stock valued at $100,000.
The Company included in revenue under collaboration and license
agreements in 2007 the $1.0 million total license fee that
the Company received from SetPoint and included the payments of
$100,000 in cash and SetPoint junior preferred stock valued at
$100,000 that the Company made to The Feinstein Institute in
research and development expenses. These amounts were recorded
in the second quarter of 2007. Under the license agreement,
SetPoint also has agreed to pay the Company $1.0 million,
excluding a $200,000 payment that the Company would be obligated
to pay The Feinstein Institute, upon full regulatory approval of
a licensed product by the U.S. Food and Drug Administration (the
FDA) or a foreign counterpart agency and royalties
based on a net sales of licensed products and methods by
SetPoint and its affiliates.
On March 14, 2008, the Company sold the 400,000 shares
of junior preferred stock issued to it by SetPoint in May 2007
in connection with SetPoints first financing for an
aggregate purchase price of $400,000. The Company sold these
shares of junior preferred stock to two investors which had
previously participated in SetPoints first financing. The
purchase price is subject to adjustments if these investors sell
or receive consideration for these shares of junior preferred
stock pursuant to an acquisition of SetPoint prior to
February 1, 2009 at a price per share greater than the
price they paid the Company.
At June 30, 2008, the Companys accounts receivable
balance of $1.5 million was net of allowances of $34,000.
At December 31, 2007, the Companys accounts
receivable balance of $1.3 million was net of allowances of
$29,000.
|
|
(3)
|
Cash
Equivalents and Investments
|
The Company considers all highly-liquid investments with
original maturities of three months or less when purchased to be
cash equivalents.
At June 30, 2008, the Company held $284,000 in an auction
rate security with a AAA credit rating upon purchase. The
Company has been informed that there is insufficient demand at
auction for this security. As a result, this amount is currently
not liquid and may not become liquid unless the issuer is able
to refinance it. The Company has classified its $284,000 auction
rate security as a long-term investment and has included the
amount in other assets on the Companys accompanying
balance sheet. The unrealized gain (loss) during the period is
recorded as an adjustment to stockholders equity. The cost
of the debt securities, if any, is adjusted for amortization of
premiums and accretion of discounts to maturity. The
amortization or accretion is included in interest income
(expense) in the corresponding period.
As a result of the adoption of SFAS 157 as of
January 1, 2008, the Company is now required to provide
additional disclosures as part of its financial statements.
SFAS 157 establishes a valuation hierarchy for disclosure
of the inputs to valuation used to measure fair value. This
hierarchy prioritizes the inputs into three broad levels as
follows. Level 1 inputs are quoted prices (unadjusted) in
active markets for identical assets or liabilities. Level 2
inputs are quoted prices for similar assets and liabilities in
active markets or inputs that are observable for the asset or
liability, either directly or indirectly through market
corroboration, for substantially the full term of the financial
instrument. Level 3 inputs are unobservable inputs based on
the Companys own
F-44
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
assumptions used to measure assets and liabilities at fair
value. A financial asset or liabilitys classification
within the hierarchy is determined based on the lowest level
input that is significant to the fair value measurement.
The following table provides the assets and liabilities carried
at fair value measured on a recurring basis as of June 30,
2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at June 30, 2008 Using
|
|
|
|
|
|
|
|
|
|
Significant Other
|
|
|
Significant
|
|
|
|
Total Carrying
|
|
|
Quoted Prices in
|
|
|
Observable
|
|
|
Unobservable
|
|
|
|
Value at June 30,
|
|
|
Active Markets
|
|
|
Inputs
|
|
|
Inputs
|
|
|
|
2008
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Available for sale securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government-backed securities
|
|
$
|
1,048
|
|
|
$
|
|
|
|
$
|
1,048
|
|
|
$
|
|
|
Auction rate security
|
|
|
284
|
|
|
|
|
|
|
|
|
|
|
|
284
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value
|
|
$
|
1,332
|
|
|
$
|
|
|
|
$
|
1,048
|
|
|
$
|
284
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table provides a rollforward of the Companys
assets and liabilities whose fair value measurements were
Level 3 (in thousands):
|
|
|
|
|
|
|
Auction Rate
|
|
|
|
Security
|
|
|
|
(Level 3)
|
|
|
Total carrying value at January 1, 2008
|
|
$
|
300
|
|
Unrealized loss
|
|
|
(13
|
)
|
Total carrying value at March 31, 2008
|
|
$
|
287
|
|
Unrealized loss
|
|
|
(3
|
)
|
|
|
|
|
|
Total carrying value at June 30, 2008
|
|
$
|
284
|
|
|
|
|
|
|
U.S. government-backed securities are valued using a market
approach based upon the quoted market prices of identical
instruments when available or other observable inputs such as
trading prices of identical instruments in inactive markets.
Scheduled maturity dates of U.S. government-backed
securities as of June 30, 2008, had original maturities of
less than 90 days and therefore investments were classified
as cash equivalents.
The Companys auction rate security instrument is
classified as an available-for-sale security and recorded at
fair value. However, due to recent events in credit markets,
auctions for this security failed during the first and second
quarters of 2008. Therefore, the fair value of this security is
estimated utilizing a discounted cash flow analysis or other
type of valuation model as of June 30, 2008. This analysis
considers, among other items, the collateralization underlying
the security investments, the creditworthiness of the
counterparty, the timing of expected future cash flows and the
expectation of the next time the security is expected to have a
successful auction.
As a result of the temporary decline in the fair value of the
Companys auction rate security, which the Company
attributes to liquidity issues rather than credit issues, the
Company has recorded an unrealized loss of $16,000 to
accumulated other comprehensive loss.
|
|
(4)
|
Research
and License Agreements
|
In December 2003, the Company entered into an agreement to
in-license the controlled-release formulation and the injectable
formulation of zileuton from Abbott Laboratories
(Abbott) and entered into an agreement with Jagotec
AG, a subsidiary of SkyePharma PLC (Jagotec), to
in-license the controlled-release technology
F-45
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
relating to zileuton from Jagotec. Under these agreements, the
Company is required to make milestone payments for successful
completion of the technology transfer, filing and approval of
the product in the United States and commercialization of the
product. In May 2007, the Company received approval by the FDA
of the new drug application (NDA) for ZYFLO CR. As a
result of the FDA approval, the Company paid $3.1 million
under these agreements in June 2007, and accrued an additional
$1.8 million and $1.7 million due on the first and
second anniversary, respectively, of the FDAs approval of
ZYFLO CR. The amounts due on the first and second anniversary of
the FDAs approval were accrued at the present value of the
total $3.8 million owed, and the accretion of the discount
is included in interest expense. The $3.1 million paid as a
result of the FDAs approval of ZYFLO CR and the accrued
$1.8 million and $1.7 million that will be due on the
first and second anniversary, respectively, of the FDAs
approval of ZYFLO CR were included in the Companys
research and development expenses in the second quarter of 2007.
The Company included the $1.9 million that was due on the
first anniversary in accounts payable at June 30, 2008 and
paid the amount in July 2008. For the three and six months ended
June 30, 2008, the Company recorded interest expense of
$36,000 and $79,000, respectively, related to the accretion of
the discount.
Inventory is stated at the lower of cost or market, with cost
determined under the
first-in,
first-out (FIFO) method. As of June 30, 2008,
the Company held $7.8 million in inventory to be used for
commercial sales related to its commercial product, ZYFLO CR.
The Company analyzes its inventory levels quarterly and records
reserves for inventory that has become obsolete, inventory that
has a cost basis in excess of its expected net realizable value
and inventory in excess of expected requirements. Expired
inventory is disposed of and the related costs are written off.
At June 30, 2008, the Company had an inventory reserve of
$2.5 million. The inventory reserve relates to product that
did not meet the Companys product release specifications
for ZYFLO CR and to tablet cores of ZYFLO CR that were on
quality assurance hold and that could not complete manufacturing
within the NDA-specified manufacturing timelines.
Inventory consisted of the following at June 30, 2008 and
December 31, 2007, respectively (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Raw material
|
|
$
|
6,172
|
|
|
$
|
2,587
|
|
Work in process
|
|
|
4,021
|
|
|
|
3,062
|
|
Finished goods
|
|
|
71
|
|
|
|
766
|
|
|
|
|
|
|
|
|
|
|
Total inventory
|
|
|
10,264
|
|
|
|
6,415
|
|
Less: reserve
|
|
|
(2,504
|
)
|
|
|
(816
|
)
|
|
|
|
|
|
|
|
|
|
Inventory, net
|
|
$
|
7,760
|
|
|
$
|
5,599
|
|
|
|
|
|
|
|
|
|
|
Risk
and uncertainties
The Company currently purchases zileuton active pharmaceutical
ingredient (API) for its commercial requirements for
ZYFLO CR and ZYFLO from a single source. In addition, the
Company currently contracts with single parties for the
manufacture of tablet cores of ZYFLO CR and the coating and
packaging of ZYFLO CR tablets and the manufacture of ZYFLO. The
disruption or termination of the supply of the API, a
significant increase in the cost of the API from this single
source or the disruption or termination of the manufacturing of
the commercial product would have a material adverse effect on
the Companys business, financial position and results of
operations. In addition, as discussed in Note 9, the
Company has agreed to purchase specified quantities of API in
2008 and 2009.
F-46
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Comprehensive loss is the total of net loss and all other
non-owner changes in equity. The difference between net loss, as
reported in the accompanying condensed consolidated statements
of operations for the three and six months ended June 30,
2008 and 2007, and comprehensive loss is the unrealized gain
(loss) on investments for the period. Total comprehensive loss
was $6.6 million and $13.0 million for the three
months ended June 30, 2008 and 2007, respectively, and
$17.4 million and $17.6 million for the six months
ended June 30, 2008 and 2007, respectively. The unrealized
gain (loss) on investments is the only component of accumulated
other comprehensive loss in the accompanying condensed
consolidated balance sheet.
|
|
(7)
|
Stock-Based
Compensation
|
All stock-based awards are accounted for at their fair market
value in accordance with SFAS No. 123 (revised 2004),
Share-Based Payment (SFAS 123(R)) and
EITF
No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services.
Stock option activity for the six-month period ended
June 30, 2008 was as follows:
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
|
|
|
Weighted-Average
|
|
|
|
Number of
|
|
|
Exercise Price
|
|
|
|
Shares
|
|
|
per Share
|
|
|
Outstanding January 1
|
|
|
5,020,903
|
|
|
$
|
4.20
|
|
Granted
|
|
|
12,000
|
|
|
|
0.90
|
|
Exercised
|
|
|
|
|
|
|
|
|
Cancelled
|
|
|
(1,985,565
|
)
|
|
|
4.06
|
|
|
|
|
|
|
|
|
|
|
Outstanding June 30
|
|
|
3,047,338
|
|
|
$
|
4.28
|
|
|
|
|
|
|
|
|
|
|
Vested and Expected to Vest June 30
|
|
|
2,776,753
|
|
|
$
|
4.34
|
|
|
|
|
|
|
|
|
|
|
Exercisable June 30
|
|
|
1,973,525
|
|
|
$
|
4.77
|
|
|
|
|
|
|
|
|
|
|
The weighted-average remaining contractual term and the
aggregate intrinsic value for options outstanding at
June 30, 2008 were 6.3 years and zero, respectively.
The weighted-average remaining contractual term and the
aggregate intrinsic value for options exercisable at
June 30, 2008 were 5.3 years and zero, respectively.
The weighted-average remaining contractual term and the
aggregate intrinsic value for options vested and expected to
vest at June 30, 2008 were 6.2 years and zero,
respectively. There were no options exercised during the six
months ended June 30, 2008.
The total fair value of the shares vested and unexercised during
the three and six months ended June 30, 2008 was $90,000
and $147,000, respectively. As of June 30, 2008, there was
$3.3 million of total unrecognized compensation expense
related to unvested share-based compensation awards granted
under the Companys stock plans, which is expected to be
recognized over a weighted-average period of 1.9 years.
The Company anticipates recording additional stock-based
compensation expense of $900,000 in the remaining two quarters
of 2008, $1.6 million in 2009 and $742,000 thereafter
relating to the amortization of unrecognized compensation
expense as of June 30, 2008. These anticipated compensation
expenses do not include any adjustment for new or additional
options to purchase common stock granted to employees.
Option valuation models require the input of highly subjective
assumptions. The Company has computed the impact under the fair
value method for options granted using the Black-Scholes
option-pricing model for the six months ended June 30, 2008
and 2007. The Company did not grant options during the three
months ended June 30, 2008. The Company increased its
expected volatility assumption for the six months ended
June 30, 2008 to 73% from 70% in the corresponding period
of 2007. The rate is based on the Companys actual
F-47
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
historical volatility since its initial public offering. The
expected life of options granted was estimated using the
simplified method calculation as prescribed by SEC Staff
Accounting Bulletin No. 110. The assumptions used and
weighted-average information are as follows:
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Risk free interest rate
|
|
|
2.8
|
%
|
|
|
4.8
|
%
|
Expected dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Expected forfeiture rate
|
|
|
10.6
|
%
|
|
|
10.2
|
%
|
Expected life
|
|
|
6.25
|
years
|
|
|
6.20
|
years
|
Expected volatility
|
|
|
73
|
%
|
|
|
70
|
%
|
Weighted-average fair value of options granted equal to fair
value
|
|
$
|
0.60
|
|
|
$
|
1.52
|
|
|
|
(8)
|
Basic and
Diluted Loss per Share
|
Basic and diluted net loss per common share is calculated by
dividing the net loss by the weighted-average number of
unrestricted common shares outstanding during the period.
Diluted net loss per common share is the same as basic net loss
per common share because the effects of potentially dilutive
securities are anti-dilutive for all periods presented.
Anti-dilutive securities that are not included in the diluted
net loss per share calculation aggregated 10,638,645 and
12,835,478 as of June 30, 2008 and 2007, respectively.
These anti-dilutive securities consist of outstanding stock
options, warrants, and unvested restricted common stock as of
June 30, 2008 and 2007.
|
|
(9)
|
Commitments
and Contingencies
|
The Company has entered into various agreements with third
parties and certain related parties in connection with research
and development activities relating to its existing product
candidates as well as discovery efforts relating to potential
new product candidates. These agreements include costs for
research and development and license agreements that represent
the Companys fixed obligations payable to sponsor research
and minimum royalty payments for licensed patents. These amounts
do not include any additional amounts that the Company may be
required to pay under its license agreements upon the
achievement of scientific, regulatory and commercial milestones
that may become payable depending on the progress of scientific
development and regulatory approvals, including milestones such
as the submission of an investigational new drug application to
the FDA, similar submissions to foreign regulatory authorities
and the first commercial sale of the Companys products in
various countries. These agreements include costs related to
manufacturing, clinical trials and preclinical studies performed
by third parties. The estimated amount that may be incurred in
the future under these agreements totals approximately
$26.0 million as of June 30, 2008. The amount and
timing of these commitments may change, as they are largely
dependent on the rate of enrollment in the Companys
clinical trials and timing of the development of the
Companys product candidates. As of June 30, 2008, the
Company had $93,000 and $864,000 included in prepaid expenses
and accrued expenses, respectively, related to its research and
development agreements. These research and development expenses
are accounted for as such costs are incurred. In addition, as of
June 30, 2008, the Company had $1.9 million in license
fees in accounts payable and $1.8 million in accrued
license fees representing the net present value of the
Companys milestone obligations due on the first and second
anniversary, respectively, of the FDAs approval of ZYFLO
CR. In addition, during the quarter ended March 31, 2008,
the Company accrued approximately $1.1 million in
contractual costs as a result of the Companys termination
of a Phase IV clinical trial for ZYFLO CR. At June 30,
2008, $768,000 remains in accrued expenses related to these
termination costs.
In addition, on August 20, 2007, the Company entered into
an agreement with Jagotec under which Jagotec agreed to
manufacture and supply bulk uncoated tablets of ZYFLO CR to the
Company for commercial sale. The Company previously had
contracted with Jagotec for the manufacture of ZYFLO CR for
clinical trials
F-48
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
and regulatory review. Under the terms of the prior agreement,
the Company and Jagotec had agreed to negotiate a commercial
manufacturing agreement for ZYFLO CR. SkyePharma PLC has
guaranteed the performance by Jagotec of all obligations under
the commercial manufacturing agreement. The Company has agreed
to purchase minimum quantities of ZYFLO CR during each
12-month
period for the first five years following marketing approval of
ZYFLO CR by the FDA. For the term of the contract, the Company
has agreed to purchase specified amounts of its requirements for
ZYFLO CR from Jagotec. The commercial manufacturing agreement
has an initial term of five years beginning on May 22,
2007, and will automatically continue thereafter, unless the
Company provides Jagotec with
24-months
prior written notice of termination or Jagotec provides the
Company with
36-months
prior written notice of termination.
In February 2005, the Company entered into a manufacturing
and supply agreement with Rhodia Pharma Solutions, which was
assigned to Pharma Solutions Ltd. (Shasun), for
commercial production of the API for ZYFLO and ZYFLO CR, subject
to specified limitations, through December 31, 2009. Under
this agreement, the Company committed to purchase minimum
amounts of API in the first quarter of 2008. In addition, the
Company has agreed to purchase specified quantities of API in
2008 and 2009, in the amount of $2.0 million and
$2.0 million, respectively, with approximately
$1.3 million in 2009 subject to the right of cancellation.
The API purchased from Shasun currently has a shelf-life of
36 months. The Company evaluates the need to provide
reserves for contractually committed future purchases of
inventory that may be in excess of forecasted future demand. In
making these assessments, the Company is required to make
judgments as to the future demand for current or committed
inventory levels and as to the expiration dates of its product.
As of June 30, 2008, no reserves have been recorded for
purchase commitments.
In May 2007, the Company entered into a three year manufacturing
services agreement with Patheon Pharmaceuticals Inc.
(Patheon), under which Patheon agreed to coat,
conduct quality control and quality assurance and stability
testing and package commercial supplies of ZYFLO CR in tablet
form. Under this agreement, the Company is responsible for
supplying uncoated ZYFLO CR tablet cores to Patheon. The Company
has agreed to purchase at least 50% of its requirements for such
manufacturing services for ZYFLO CR for sale in the United
States from Patheon each year for the term of the agreement.
In addition, in accordance with its co-promotion agreement with
DEY, the Company has entered into advertising and promotional
contracts related to its marketing support for ZYFLO CR. The
estimated amount that may be incurred in the future under these
agreements totals approximately $6.7 million as of
June 30, 2008.
The Company is also party to a number of agreements that require
it to make milestone payments, royalty payments on net sales of
the Companys products and payments on sublicense income
received by the Company. In addition, from time to time, the
Company may have certain contingent liabilities that arise in
the ordinary course of business. The Company accrues for
liabilities when it is probable that future expenditures will be
made and such expenditures can be reasonably estimated. The
Company is not a party to any pending material litigation or
other material legal proceedings and was not a party to any such
litigation or proceedings during any of the periods presented.
|
|
(10)
|
DEY
Co-Promotion and Marketing Services Agreements
|
On March 13, 2007, the Company entered into an agreement
with DEY under which the Company and DEY agreed to jointly
promote ZYFLO and ZYFLO CR. Under the co-promotion and marketing
services agreement, the Company granted DEY an exclusive right
and license to promote and detail ZYFLO and ZYFLO CR in the
United States, together with the Company. Under the co-promotion
agreement, DEY paid the Company a non-refundable upfront payment
of $3.0 million in March 2007, a milestone payment of
$4.0 million in June 2007 following approval by the FDA of
the NDA for ZYFLO CR in May 2007 and a milestone payment of
$5.0 million in December 2007 following the commercial
launch of ZYFLO CR. Under the co-promotion agreement, the
Company will pay DEY a commission on quarterly net sales of
ZYFLO and ZYFLO CR, after third-party royalties, in excess of
$1.95 million. From the date DEY began detailing
F-49
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
ZYFLO through the commercial launch of ZYFLO CR, the commission
rate was 70%, following the commercial launch of ZYFLO CR in
September 2007 through December 31, 2010, the commission
rate is 35% and from January 1, 2011 through
December 31, 2013, the commission rate is 20%. The
co-promotion agreement expires on December 31, 2013 and may
be extended upon mutual agreement by the parties.
The Company deferred the $12 million in aggregate payments
received and is amortizing these payments over the term of the
agreement. The amortization of the upfront and milestone
payments will be offset by the co-promotion fees paid to DEY for
promoting ZYFLO and ZYFLO CR. The Company records all ZYFLO and
ZYFLO CR sales generated by the combined sales force and records
any co-promotion fees paid to DEY and the amortization of the
upfront and milestone payments as sales and marketing expenses.
For the three and six months ended June 30, 2008,
approximately $483,000 and $684,000, respectively, were
amortized from the deferred
co-promotion
fees representing the amount earned by DEY during this period.
On June 25, 2007, the Company entered into a definitive
agreement with DEY to jointly promote DEYs product
PERFOROMISTtm
(formoterol fumarate) Inhalation Solution
(PERFOROMIST), for the treatment of chronic
obstructive pulmonary disease (COPD). In October
2007, the Company announced that it commercially launched
PERFOROMIST with DEY. Under the agreement, DEY agreed to pay the
Company a commission on retail sales of PERFOROMIST above a
specified baseline. On July 2, 2008, the Company provided
notice to DEY that it had exercised its contractual right to
terminate the co-promotion agreement for PERFOROMIST. The
termination is effective September 30, 2008.
|
|
(11)
|
Restructuring
Plans and Impairment of Asset
|
In the second quarter of 2008, the Company recorded
restructuring charges of $1.2 million in its efforts to
reduce its operating expenses in order to better align its
operating cost structure with the current economic environment,
the current business strategy and to improve operating margins.
The business units affected included sales and marketing and
research and development.
In connection with these restructuring charges, the Company
terminated 21 employees, or approximately 28% of the
Companys workforce, in May and June 2008, resulting in
severance benefits of $1.2 million, which were accrued
during the second quarter. As a result of terminating these
employees, the Company recorded automobile lease termination
fees, outplacement service fees and an impairment charge for
software and lab equipment for which the future use was
currently uncertain totaling $41,000. At June 30, 2008, the
Company had $928,000 remaining in accrued expenses related to
the restructuring, which it expects to pay in full by the end of
the fourth quarter. The Company may consider further reductions
in its headcount in additional areas of its business in the
future in order to conserve cash and reduce expenses. The
nature, extent and timing of future reductions will be made
based on the Companys business needs and financial
resources.
During the second quarter of 2008, the Company concluded that
the estimated undiscounted cash flows associated with a fixed
asset would not recover the carrying amount. Accordingly, the
Company adjusted this asset to its current fair market value
estimated to be $100,000. The Company recorded a $393,000
impairment charge for the asset and included the impairment
charge in research and development expenses.
|
|
(12)
|
Subsequent
Event Legal Proceedings
|
On September 17, 2008, a purported shareholder class action
lawsuit was filed by a single plaintiff against the Company and
each of its directors in the Court of Chancery of The State of
Delaware. The action is captioned Jeffrey Benison IRA v.
Critical Therapeutics, Inc., Trevor Phillips, Richard W. Dugan,
Christopher Mirabelli, and Jean George (Case No. 4039,
Court of Chancery, State of Delaware). The plaintiff, which
claims to be a stockholder of the Company, brought the lawsuit
on its own behalf, and is seeking certification of the lawsuit
as a class action on behalf of all stockholders of the Company,
except the defendants and their affiliates. The complaint
alleges, among other things, that the defendants breached
fiduciary duties of loyalty and good faith, including a
fiduciary duty of candor, by failing to provide the
Companys stockholders with a proxy statement/
F-50
CRITICAL
THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
prospectus adequate to enable them to cast an informed vote on
the proposed Merger, and by possibly failing to maximize
stockholder value by entering into an agreement that effectively
discourages competing offers. The complaint seeks, among other
things, an order (i) enjoining the defendants from
proceeding with or implementing the proposed Merger on the terms
and under the circumstances as they presently exist,
(ii) invalidating the provisions of the proposed Merger
that purportedly improperly limit the effective exercise of the
defendants continuing fiduciary duties;
(iii) ordering defendants to explore alternatives and to
negotiate in good faith with all bona fide interested
parties; (iv) in the event the proposed Merger is
consummated, rescinding it and setting it aside or awarding
rescissory damages; (v) awarding compensatory damages
against defendants, jointly and severally; and
(vi) awarding the plaintiff and the purported class their
costs and fees.
The Company intends to defend against the lawsuit vigorously.
However, the Company is currently unable to determine the
financial impact of this lawsuit, if any, and whether this
matter will have a material adverse effect on its consolidated
financial statements.
F-51
INDEX TO
CORNERSTONES CONSOLIDATED FINANCIAL STATEMENTS
TABLE OF
CONTENTS
|
|
|
|
|
|
|
Page
|
|
CORNERSTONE CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
Report of Independent Registered Public Accounting Firm
|
|
|
F-53
|
|
Consolidated Balance Sheets at December 31, 2007 and
December 31, 2006
|
|
|
F-54
|
|
Consolidated Statements of Operations for the Years ended at
December 31, 2007, December 31, 2006 and
December 31, 2005
|
|
|
F-55
|
|
Consolidated Statements of Stockholders Deficit and
Comprehensive Income (Loss) for the Years ended at
December 31, 2007, December 31, 2006 and
December 31, 2005
|
|
|
F-56
|
|
Consolidated Statements of Cash Flows for the Years ended at
December 31, 2007, December 31, 2006 and
December 31, 2005
|
|
|
F-57
|
|
Notes to Consolidated Financial Statements
|
|
|
F-59
|
|
CORNERSTONE CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
|
|
|
|
|
Consolidated Balance Sheets at June 30, 2008 (Unaudited)
and December 31, 2007
|
|
|
F-88
|
|
Consolidated Statements of Operations for the Six Months ended
at June 30, 2008 and June 30, 2007 (Unaudited)
|
|
|
F-89
|
|
Consolidated Statements of Cash Flows for the Six Months ended
at June 30, 2008 and at June 30, 2007 (Unaudited)
|
|
|
F-90
|
|
Notes to Consolidated Financial Statements
|
|
|
F-91
|
|
F-52
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Stockholders
Cornerstone BioPharma Holdings, Inc. and Subsidiaries
We have audited the accompanying consolidated balance sheets of
Cornerstone BioPharma Holdings, Inc. and Subsidiaries (a
Delaware corporation) as of December 31, 2007 and 2006, and
the related consolidated statements of operations,
stockholders deficit and comprehensive income (loss), and
cash flows for each of the three years in the period ended
December 31, 2007. These financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audit included
consideration of internal control over financial reporting as a
basis for designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion
on the effectiveness of the Companys internal control over
financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the financial
position of Cornerstone BioPharma Holdings, Inc. as of
December 31, 2007 and 2006, and the results of its
operations and its cash flows for each of the three years in the
period ended December 31, 2007 in conformity with
accounting principles generally accepted in the United States of
America.
/s/ GRANT THORNTON LLP
Raleigh, North Carolina
July 11, 2008
F-53
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
|
(In thousands, except share and per share data)
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
241
|
|
|
$
|
116
|
|
Marketable security (restricted in 2006)
|
|
|
8
|
|
|
|
153
|
|
Accounts receivable, net
|
|
|
6,529
|
|
|
|
2,280
|
|
Amounts due from related parties
|
|
|
648
|
|
|
|
152
|
|
Inventories, net
|
|
|
2,998
|
|
|
|
1,847
|
|
Prepaid expenses
|
|
|
278
|
|
|
|
266
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
10,702
|
|
|
|
4,814
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
209
|
|
|
|
217
|
|
|
|
|
|
|
|
|
|
|
Other assets:
|
|
|
|
|
|
|
|
|
Product rights, net
|
|
|
4,936
|
|
|
|
5,456
|
|
Amounts due from related parties
|
|
|
29
|
|
|
|
28
|
|
Deposits
|
|
|
33
|
|
|
|
67
|
|
|
|
|
|
|
|
|
|
|
Total other assets
|
|
|
4,998
|
|
|
|
5,551
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
15,909
|
|
|
$
|
10,582
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
2,214
|
|
|
$
|
1,432
|
|
Accrued expenses
|
|
|
11,163
|
|
|
|
10,142
|
|
Current portion of license agreement liability
|
|
|
576
|
|
|
|
720
|
|
Line of credit
|
|
|
1,750
|
|
|
|
1,750
|
|
Income taxes payable
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
15,833
|
|
|
|
14,044
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
License agreement liability, less current portion
|
|
|
2,959
|
|
|
|
970
|
|
Note payable, related party
|
|
|
9,412
|
|
|
|
9,412
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities
|
|
|
12,371
|
|
|
|
10,382
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
28,204
|
|
|
|
24,426
|
|
|
|
|
|
|
|
|
|
|
Stockholders deficit
|
|
|
|
|
|
|
|
|
Common stock $0.0001 par value,
50,000,000 shares authorized, 24,926,150 shares issued
and outstanding
|
|
|
2
|
|
|
|
2
|
|
Additional paid-in capital
|
|
|
801
|
|
|
|
|
|
Accumulated other comprehensive loss
|
|
|
|
|
|
|
(178
|
)
|
Accumulated deficit
|
|
|
(13,098
|
)
|
|
|
(13,668
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders deficit
|
|
|
(12,295
|
)
|
|
|
(13,844
|
)
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders deficit
|
|
$
|
15,909
|
|
|
$
|
10,582
|
|
|
|
|
|
|
|
|
|
|
F-54
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(In thousands, except share and per share data)
|
|
|
Net revenues
|
|
$
|
28,071
|
|
|
$
|
22,117
|
|
|
$
|
17,470
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales (exclusive of amortization of product
rights of $3,160, $2,646 and $1,887 in the years ended
December 31, 2007, 2006 and 2005, respectively)
|
|
|
3,300
|
|
|
|
2,151
|
|
|
|
3,437
|
|
Sales and marketing
|
|
|
10,391
|
|
|
|
7,120
|
|
|
|
13,889
|
|
Royalties
|
|
|
3,409
|
|
|
|
1,663
|
|
|
|
1,933
|
|
General and administrative
|
|
|
4,106
|
|
|
|
3,679
|
|
|
|
4,881
|
|
Research and development
|
|
|
948
|
|
|
|
249
|
|
|
|
266
|
|
Amortization and depreciation
|
|
|
3,231
|
|
|
|
2,704
|
|
|
|
1,939
|
|
Other charges
|
|
|
245
|
|
|
|
3,581
|
|
|
|
1,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
25,630
|
|
|
|
21,147
|
|
|
|
27,345
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
2,441
|
|
|
|
970
|
|
|
|
(9,875
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net
|
|
|
(1,410
|
)
|
|
|
(1,240
|
)
|
|
|
(1,557
|
)
|
Loss on marketable security
|
|
|
(324
|
)
|
|
|
|
|
|
|
|
|
Other expenses
|
|
|
(7
|
)
|
|
|
(35
|
)
|
|
|
(6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expenses
|
|
|
(1,741
|
)
|
|
|
(1,275
|
)
|
|
|
(1,563
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes
|
|
|
700
|
|
|
|
(305
|
)
|
|
|
(11,438
|
)
|
Provision for income taxes
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
570
|
|
|
$
|
(305
|
)
|
|
$
|
(11,438
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share, basic
|
|
$
|
0.02
|
|
|
$
|
(0.01
|
)
|
|
$
|
(0.46
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share, diluted
|
|
$
|
0.02
|
|
|
$
|
(0.01
|
)
|
|
$
|
(0.46
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares, basic
|
|
|
24,926,150
|
|
|
|
25,022,594
|
|
|
|
25,126,027
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares, diluted
|
|
|
28,356,133
|
|
|
|
25,022,594
|
|
|
|
25,126,027
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-55
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
DEFICIT AND COMPREHENSIVE INCOME (LOSS)
YEARS ENDED DECEMBER 31, 2007, 2006 AND 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
Stock
|
|
|
Additional
|
|
|
Other
|
|
|
|
|
|
Total
|
|
|
Comprehensive
|
|
|
|
Common Stock
|
|
|
Subscription
|
|
|
Paid-in
|
|
|
Comprehensive
|
|
|
Accumulated
|
|
|
Stockholders
|
|
|
Income
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Receivable
|
|
|
Capital
|
|
|
Loss
|
|
|
Deficit
|
|
|
Deficit
|
|
|
(Loss)
|
|
|
|
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2004
|
|
|
25,000,000
|
|
|
$
|
2
|
|
|
$
|
(1
|
)
|
|
$
|
47
|
|
|
|
|
|
|
$
|
(1,702
|
)
|
|
$
|
(1,654
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares of common stock to directors
|
|
|
200,000
|
|
|
|
|
|
|
|
|
|
|
|
20
|
|
|
|
|
|
|
|
|
|
|
|
20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants to purchase common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
164
|
|
|
|
|
|
|
|
|
|
|
|
164
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collection of stock subscription receivable
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,438
|
)
|
|
|
(11,438
|
)
|
|
$
|
(11,438
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(11,438
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2005
|
|
|
25,200,000
|
|
|
|
2
|
|
|
|
|
|
|
|
235
|
|
|
|
|
|
|
|
(13,140
|
)
|
|
|
(12,903
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options to purchase common stock
|
|
|
101,150
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redemption of restricted common stock
|
|
|
(375,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
78
|
|
|
|
|
|
|
|
|
|
|
|
78
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants to purchase common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(178
|
)
|
|
|
|
|
|
|
(178
|
)
|
|
$
|
(178
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repurchase of warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(324
|
)
|
|
|
|
|
|
|
(223
|
)
|
|
|
(547
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(305
|
)
|
|
|
(305
|
)
|
|
|
(305
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(483
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2006
|
|
|
24,926,150
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
(178
|
)
|
|
|
(13,668
|
)
|
|
|
(13,844
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
293
|
|
|
|
|
|
|
|
|
|
|
|
293
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants to purchase common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
508
|
|
|
|
|
|
|
|
|
|
|
|
508
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(145
|
)
|
|
|
|
|
|
|
(145
|
)
|
|
$
|
(145
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification adjustment for losses on investments included
in net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
323
|
|
|
|
|
|
|
|
323
|
|
|
|
323
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
570
|
|
|
|
570
|
|
|
|
570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
748
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2007
|
|
|
24,926,150
|
|
|
$
|
2
|
|
|
$
|
|
|
|
$
|
801
|
|
|
$
|
|
|
|
$
|
(13,098
|
)
|
|
$
|
(12,295
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-56
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(In thousands)
|
|
|
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
|
570
|
|
|
|
(305
|
)
|
|
|
(11,438
|
)
|
Adjustments to reconcile net income (loss) to net cash provided
by (used in) operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization and depreciation
|
|
|
3,231
|
|
|
|
2,704
|
|
|
|
1,939
|
|
Amortization of debt discount
|
|
|
|
|
|
|
|
|
|
|
241
|
|
Issuance of common stock warrants and options for services
|
|
|
801
|
|
|
|
79
|
|
|
|
26
|
|
Loss on marketable security
|
|
|
323
|
|
|
|
|
|
|
|
|
|
Forfeiture of product rights
|
|
|
|
|
|
|
1,663
|
|
|
|
|
|
Stock received for royalties
|
|
|
|
|
|
|
(332
|
)
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
(4,249
|
)
|
|
|
(299
|
)
|
|
|
1,844
|
|
Amounts due from related parties
|
|
|
117
|
|
|
|
(186
|
)
|
|
|
(100
|
)
|
Inventories, net
|
|
|
(1,151
|
)
|
|
|
(1,629
|
)
|
|
|
690
|
|
Prepaid expenses
|
|
|
(12
|
)
|
|
|
(153
|
)
|
|
|
229
|
|
Accounts payable
|
|
|
783
|
|
|
|
(1,117
|
)
|
|
|
(432
|
)
|
Accrued expenses
|
|
|
1,020
|
|
|
|
525
|
|
|
|
7,611
|
|
Income taxes payable
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
1,563
|
|
|
|
950
|
|
|
|
610
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Advances to related parties
|
|
|
(876
|
)
|
|
|
(1,193
|
)
|
|
|
(2,567
|
)
|
Proceeds from collection of advances to related parties
|
|
|
262
|
|
|
|
1,053
|
|
|
|
1,480
|
|
Purchase of property and equipment
|
|
|
(64
|
)
|
|
|
(57
|
)
|
|
|
(125
|
)
|
Purchase of product rights
|
|
|
(75
|
)
|
|
|
(500
|
)
|
|
|
(1,500
|
)
|
Collection of deposits
|
|
|
50
|
|
|
|
|
|
|
|
|
|
Release of restricted cash
|
|
|
|
|
|
|
|
|
|
|
68
|
|
Payment of deposits
|
|
|
(15
|
)
|
|
|
(55
|
)
|
|
|
(4
|
)
|
Proceeds from sale of property and equipment
|
|
|
|
|
|
|
38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(718
|
)
|
|
|
(714
|
)
|
|
|
(2,648
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal payments on license agreement liability
|
|
$
|
(720
|
)
|
|
$
|
(250
|
)
|
|
$
|
|
|
Proceeds from line of credit
|
|
|
9,000
|
|
|
|
8,100
|
|
|
|
3,500
|
|
Principal payments on line of credit
|
|
|
(9,000
|
)
|
|
|
(6,850
|
)
|
|
|
(3,000
|
)
|
Principal payments on notes payable
|
|
|
|
|
|
|
(1,542
|
)
|
|
|
(1,512
|
)
|
Repurchase of warrants
|
|
|
|
|
|
|
(547
|
)
|
|
|
|
|
Exercise of common stock options
|
|
|
|
|
|
|
10
|
|
|
|
|
|
Proceeds from collection of stock subscription receivable
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in financing activities
|
|
|
(720
|
)
|
|
|
(1,079
|
)
|
|
|
(1,011
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
125
|
|
|
|
(843
|
)
|
|
|
(3,049
|
)
|
F-57
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
|
(In thousands)
|
|
|
Cash and cash equivalents as of beginning of year
|
|
|
116
|
|
|
|
959
|
|
|
|
4,008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents as of end of year
|
|
$
|
241
|
|
|
$
|
116
|
|
|
$
|
959
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for interest
|
|
$
|
433
|
|
|
$
|
187
|
|
|
$
|
703
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and financing
activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Product rights acquired through issuance of a license agreement
|
|
$
|
2,565
|
|
|
$
|
1,940
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note payable plus accrued interest exchanged for inventory, note
receivable and advances due from related party
|
|
$
|
|
|
|
$
|
5,429
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of a common stock warrant for product license rights
|
|
$
|
|
|
|
$
|
|
|
|
$
|
164
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-58
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
NOTE 1:
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
Nature of
Operations
Cornerstone BioPharma Holdings, Inc., together with its
subsidiaries (collectively, the Company), is a
specialty pharmaceutical company focused on acquiring,
developing and commercializing prescription products for the
respiratory market. The Companys commercial strategy is to
acquire non-promoted or underperforming branded pharmaceutical
products and then maximize their potential value by promoting
the products using its sales and marketing capabilities and
applying various product life cycle management techniques.
Business
Risk and Liquidity
The Companys consolidated financial statements have been
prepared on a basis which assumes that the Company will continue
as a going concern and which contemplates the realization of
assets and the satisfaction of liabilities and commitments in
the normal course of business. From inception in 2004 through
2006, the Company incurred operating losses, including net
losses of $305,000 in 2006 and $11.4 million in 2005. The
Companys net income was $570,000 in the year ended
December 31, 2007. As of December 31, 2007, the
Companys accumulated deficit was $13.1 million.
The Company expects to continue to incur significant development
and commercialization expenses as it advances the development of
its product candidates; seeks regulatory approvals for its
product candidates that successfully complete clinical testing;
and expands its sales team and marketing capabilities to prepare
for the commercial launch of future products, subject to
approval by the U.S. Food and Drug Administration
(FDA). The Company also expects to incur additional
expenses to add operational, financial and management
information systems and personnel, including personnel to
support its product development efforts. Accordingly, the
Company will need to increase its revenues to be able to sustain
and increase its profitability on an annual and quarterly basis.
There is no assurance that the Company will be able to do so.
The Companys failure to achieve consistent profitability
could impair its ability to raise capital, expand its business,
diversify its product offerings and continue its operations.
To the extent that the Companys capital resources are
insufficient to meet its future capital requirements, the
Company will need to finance its cash needs through public or
private equity offerings, debt financings, corporate
collaboration and licensing arrangements or other financing
alternatives. The Companys only committed external source
of funds is borrowing availability under its line of credit. The
Companys ability to borrow under the line of credit is
subject to its satisfaction of specified conditions. Additional
equity or debt financing, or corporate collaboration and
licensing arrangements, may not be available on acceptable
terms, if at all.
As of December 31, 2007, the Company had approximately
$241,000 of cash and cash equivalents on hand and borrowing
availability of approximately $2.25 million under its line
of credit. Based on its current operating plans, the Company
believes that its existing cash and cash equivalents, revenues
from product sales and borrowing availability under the line of
credit are sufficient to continue to fund its existing level of
operating expenses and capital expenditure requirements as a
standalone company for the foreseeable future. However, lower
than projected cash flows as a result of reduced net product
sales or increased expenses could require the Company to raise
additional capital in order to sustain its operations. There can
be no assurance that managements plan will be executed as
anticipated.
Principles
of Consolidation
The Companys consolidated financial statements include the
accounts of Cornerstone BioPharma Holdings, Inc., a Delaware
corporation, Cornerstone BioPharma, Inc., a Nevada corporation,
Cornerstone Biopharma, Ltd., an Anguilla international business
company and Aristos Pharmaceuticals, Inc., a Delaware
corporation.
F-59
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Cornerstone Biopharma, Ltd. was dissolved in September 2007. All
significant intercompany accounts and transactions have been
eliminated.
Use of
Estimates
The preparation of financial statements in conformity with
accounting principles generally accepted in the United States of
America (GAAP) requires management to make estimates
and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities
at the date of the financial statements, and the reported
amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates or assumptions.
The more significant estimates reflected in the Companys
consolidated financial statements include certain judgments
regarding revenue recognition, product rights, inventory
valuation, accrued expenses and stock-based compensation.
Segment
and Geographic Information
The Company follows the provisions of Statement of Financial
Accounting Standards (SFAS) No. 131,
Disclosures about Segments of an Enterprise and Related
Information (SFAS 131). SFAS 131
establishes standards for reporting financial and descriptive
information regarding operating segments. SFAS 131 also
establishes standards for related disclosures about products and
services and geographic areas. Operating segments are identified
as components of an enterprise about which separate discrete
financial information is available for evaluation by the chief
operating decision maker, or decision-making group, in making
decisions as to how to allocate resources and assess
performance. The Companys chief operating decision maker,
as defined under SFAS No. 131, is the chief executive
officer. The Company believes it operates in one segment. All of
the Companys revenues are generated in the United States
and all of its assets are located in the United States.
Significant
Concentrations
Two customers accounted for 92% and 67% of the total outstanding
trade accounts receivable as of December 31, 2007 and 2006,
respectively. Three customers accounted for approximately 91%,
83% and 86% of gross product sales during the years ended
December 31, 2007, 2006 and 2005, respectively.
Cash and
Cash Equivalents
The Company considers all highly liquid investments with
maturities of three months or less when purchased to be cash
equivalents.
The Company maintains cash deposits with federally insured banks
that may at times exceed federally insured limits. As of
December 31, 2007 and 2006, the Company had balances of
approximately $130,000 and $5,000, respectively, in excess of
federally insured limits.
Marketable
Security
The Company recorded its investment in a marketable security in
accordance with SFAS No. 115, Accounting for Certain
Investments in Debt and Equity Securities
(SFAS 115). The classification of
securities is generally determined at the date of purchase. The
marketable security of the Company is classified as
available-for-sale and reported at fair value with unrealized
losses recognized net of tax in other comprehensive loss. Gains
and losses on sales of investments in marketable securities,
which are computed based on specific identification of the
adjusted cost of each security, are included in investment
income at the time of the sale.
The investment is in common stock of a U.S. publicly traded
company owned by the Company that is classified as
available-for-sale, included in current assets and reported at
fair value with unrealized loss reported in 2006. The investment
was received under the terms of an agreement and restricted from
trading for one year from the acquisition date of
September 8, 2006. The initial value of the investment was
determined
F-60
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
by taking a 15% discount from the market value to reflect
trading restrictions. During 2007, the restriction on the
investment in common stock was removed. As of December 31,
2007, a loss of approximately $323,000 was recorded for the
other-than-temporary impairment of the investment in accordance
with SFAS 115, as management does not believe the value of
these securities will be recovered.
Accounts
Receivable
Accounts receivable are stated less an allowance for discounts
of approximately $81,000 as of December 31, 2007 and
$44,000 as of December 31, 2006. The Companys policy
is to give its customers an early payment discount of 2%. The
allowance for discounts is calculated as approximately 2% of
outstanding invoices as of December 31, 2007 and 2006
because nearly all customers take advantage of these discounts.
The Company sells its products to pharmaceutical distribution
companies and retail organizations throughout the United States.
The Company performs ongoing credit evaluations and does not
require collateral. As appropriate, the Company establishes
provisions for potential credit losses. In the opinion of
management, no allowance for doubtful accounts is necessary as
of December 31, 2007 or 2006. The Company writes off
accounts receivable when management determines they are
uncollectible and credits payments subsequently received on such
receivables to bad debt expense in the period received.
Inventories
Inventories consist of raw materials, work in process and
finished goods. Raw materials include the active pharmaceutical
ingredient (API) for a product to be manufactured,
work in process includes the bulk inventory of tablets that are
in the process of being packaged for sale and finished goods
include pharmaceutical products ready for commercial sale or
distribution as samples. Inventories are stated at the lower of
cost or market value with cost determined under the
first-in,
first-out method. The Companys estimate of the net
realizable value of its inventories is subject to judgment and
estimation. The actual net realizable value of the
Companys inventories could vary significantly from the
Companys estimates and could have a material effect on the
Companys financial condition and results of operations in
any reporting period. In evaluating whether inventory is stated
at the lower of cost or market, the Company considers such
factors as the amount of inventory on hand and in the
distribution channel, estimated time required to sell such
inventory, remaining shelf life and current and expected market
conditions, including levels of competition. On a quarterly
basis, the Company analyzes its inventory levels and writes down
inventory that has become obsolete, inventory that has a cost
basis in excess of the expected net realizable value and
inventory that is in excess of expected requirements based upon
anticipated product revenues. As of December 31, 2007 and
2006, the Company established an allowance for obsolete
inventory of approximately $201,000 and $100,000, respectively.
Property
and Equipment
Property and equipment, stated at cost, are depreciated over the
estimated useful lives of the assets ranging from three to seven
years using the straight-line method. Leasehold improvements are
amortized over the lesser of their estimated useful lives or the
lives of the leases. Amortization expense for leasehold
improvements has been included in depreciation expense in these
consolidated financial statements. The useful lives of the
assets are generally as follows:
|
|
|
|
|
Furniture and fixtures
|
|
|
5 to 7 years
|
|
Machinery and equipment
|
|
|
3 to 7 years
|
|
Computers and software
|
|
|
3 to 5 years
|
|
Leasehold improvements
|
|
|
5 to 7 years
|
|
F-61
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Maintenance and repairs that are not considered renewals or
betterments are charged to expense as incurred. Upon sale or
retirement, the cost of the assets and the related accumulated
depreciation are removed from the respective property accounts
and the resulting gain or loss, if any, is reflected in the
consolidated statements of operations.
Product
Rights
Product rights are capitalized as incurred and are amortized
over the estimated useful life of the product or the remaining
trademark or patent life, whichever is shorter, on a
straight-line or other basis to match the economic benefit
received. Amortization begins once FDA approval has been
obtained and commercialization of the product begins. The
Company evaluates its product rights annually to determine
whether a revision to their useful lives should be made. This
evaluation is based on managements projection of the
future cash flows associated with the products.
Impairment
of Long-Lived Assets
The Company evaluates the recoverability of its long-lived
assets, including property and equipment and identifiable
intangible assets, in accordance with SFAS No. 144,
Accounting for the Impairment or Disposal of Long-Lived
Assets (SFAS 144). SFAS 144 requires
companies to perform impairment testing on an exception basis
whenever events or changes in circumstances suggest that the
carrying value of an asset or group of assets is not
recoverable. Recoverability of assets to be held and used is
measured by a comparison of the carrying amount of an asset to
future net cash flows expected to be generated by the asset. If
such assets are considered to be impaired, the impairment
recognized is measured by the amount by which the carrying
amount of the assets exceeds the fair value of the assets. The
Company did not record any impairment losses on long-lived
assets in 2007, 2006 or 2005.
Intellectual
Property
The Companys policy is to file patent and trademark
applications to protect technology, inventions and improvements
that are considered important to the development of its
business. The patent and trademark positions of technology
companies are uncertain and involve complex legal and factual
questions for which important legal principles are largely
unresolved. The Company accounts for its intellectual property
under the guidance of SFAS No. 142, Goodwill and
Other Intangible Assets. The costs associated with
internally developed intellectual property, such as trademarks,
are expensed as incurred.
Revenue
Recognition
The Companys consolidated net revenues represent the
Companys net product sales, royalty agreement revenues and
collaboration agreement revenues. The following table sets forth
the categories of the Companys net revenues (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Gross product sales
|
|
$
|
31,258
|
|
|
$
|
24,596
|
|
|
$
|
23,521
|
|
Sales allowances
|
|
|
(5,011
|
)
|
|
|
(4,157
|
)
|
|
|
(7,903
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
|
26,247
|
|
|
|
20,439
|
|
|
|
15,618
|
|
Royalty agreement revenues
|
|
|
1,824
|
|
|
|
1,678
|
|
|
|
753
|
|
Collaboration agreement revenues
|
|
|
|
|
|
|
|
|
|
|
1,099
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
28,071
|
|
|
$
|
22,117
|
|
|
$
|
17,470
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-62
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Product
Sales
The Company recognizes revenue from its product sales in
accordance with Securities and Exchange Commission Staff
Accounting Bulletin (SAB) No. 104, Revenue
Recognition, and SFAS No. 48, Revenue
Recognition When Right of Return Exists
(SFAS 48), upon transfer of title, which
occurs when product is received by its customers. The Company
sells its products primarily to pharmaceutical wholesalers,
distributors and pharmacies, which have the right to return the
products they purchase. Under SFAS 48, the Company is
required to reasonably estimate the amount of future returns at
the time of revenue recognition. The Company recognizes product
sales net of estimated allowances for product returns; estimated
rebates in connection with contracts relating to managed care,
Medicaid and Medicare; estimated chargebacks; price adjustments;
product vouchers; co-pay vouchers; and prompt payment and other
discounts.
The Company establishes revenue reserves on a
product-by-product
basis as its best estimate at the time of sale based on
historical experience for each product adjusted to reflect known
changes in the factors that impact such reserves. Reserves for
chargebacks, rebates, vouchers and related allowances are
established based upon contractual terms with customers;
analysis of historical levels of discounts, chargebacks, rebates
and voucher redemptions; communications with customers;
purchased information about the rate of prescriptions being
written and the levels of inventory remaining in the
distribution channel; expectations about the market for each
product; and anticipated introduction of competitive products.
Consistent with industry practice, the Company offers customers
the ability to return products in the six months prior to, and
the 12 months after, the products expire. The Company
adjusts its estimate of product returns if it becomes aware of
other factors that it believes could significantly impact its
expected returns. These factors include its estimate of
inventory levels of its products in the distribution channel,
the shelf life of the product shipped, competitive issues such
as new product entrants and other known changes in sales trends.
The Company evaluates this reserve on a quarterly basis,
assessing each of the factors described above, and adjusts the
reserve accordingly.
The Companys estimates of product rebates and price
adjustments are based on its estimated mix of sales to various
third-party payors, which are entitled either contractually or
statutorily to discounts from the Companys listed prices
of its products. The Company makes these judgments based upon
the facts and circumstances known to it in accordance with GAAP.
In the event that the sales mix to third-party payors is
different from its estimates, the Company may be required to pay
higher or lower total rebates than it has estimated.
Royalty
Agreement Revenues
The Company also receives royalties under license agreements
with a number of third parties that sell products to which the
Company has rights. The license agreements provide for the
payment of royalties based on sales of the licensed product.
These revenues are recorded based on estimates of the sales that
occurred in the relevant period. The relevant period estimates
of sales are based on interim data provided by the licensees and
analysis of historical royalties paid, adjusted for any changes
in facts and circumstances, as appropriate. The Company
maintains regular communication with its licensees to gauge the
reasonableness of its estimates. Differences between actual
royalty agreement revenues and estimated royalty agreement
revenues are reconciled and adjusted for in the period in which
they become known, typically the following quarter.
Collaboration
Agreement Revenues
The Company recognized collaboration agreement revenues as a
result of a co-promotion agreement with Lupin Pharmaceuticals,
Inc. (Lupin Pharmaceuticals). Revenues associated
with this agreement were recognized based on the calculation of
shared revenues using an
agreed-upon
average sales price that was
F-63
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
applied to the sales volume generated by the Company. The sales
volume was based on an analysis of prescription-level data by
assigned, targeted prescribers within the United States.
Advertising
Advertising expenses, which include promotional expenses and the
cost of samples, are generally expensed as incurred. Advertising
expenses related to new products are expensed upon the first
public showing of the product. Advertising expenses were
approximately $2.2 million, $967,000 and $4.7 million
for the years ended December 31, 2007, 2006 and 2005,
respectively.
Shipping
and Handling Costs
The Company includes shipping and handling costs within cost of
product sales. Shipping and handling costs were approximately
$352,000, $184,000 and $271,000 for the years ended December 31,
2007, 2006 and 2005, respectively.
Stock-Based
Compensation
Prior to January 1, 2006, the Company accounted for
stock-based awards to employees under the intrinsic value method
in accordance with Accounting Principles Board Opinion
No. 25, Accounting for Stock Issued to Employees,
and adopted the disclosure-only alternative of
SFAS No. 123, Accounting for Stock-Based
Compensation (SFAS 123). Under the
intrinsic-value method, stock-based compensation expense is
measured as the amount at which the fair value of the underlying
stock at the date of grant exceeds the exercise price. Because
the exercise price for options awarded to employees is equal to
the fair value at the grant date, the Company did not recognize
compensation expense for stock options granted to employees
prior to 2006.
Effective January 1, 2006, the Company adopted the fair
value recognition provisions of SFAS No. 123(R)
(revised 2004), Share-Based Payment
(SFAS 123(R)), using the prospective
application method, which requires the Company to recognize
compensation cost for new awards and awards modified,
repurchased or cancelled on or after January 1, 2006.
Awards outstanding at January 1, 2006 continue to be
accounted for using the accounting principles originally applied
to the award. The expense associated with stock-based
compensation is recognized on a straight-line basis over the
service period of each award.
For the year ended December 31, 2005, if the Company had
determined employee compensation expense based on the fair value
at the date of grant consistent with SFAS 123, the
Companys pro forma net loss would have been as follows (in
thousands):
|
|
|
|
|
Net loss, as reported
|
|
$
|
(11,438
|
)
|
Deduct: Total compensation expense for employee stock options,
as determined under the fair value based method for all awards
|
|
|
(2
|
)
|
|
|
|
|
|
Net loss, pro forma
|
|
$
|
(11,440
|
)
|
|
|
|
|
|
Stock-based compensation granted to non-employees is accounted
for in accordance with SFAS 123(R) and Emerging Issues Task
Force (EITF) Issue
No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services, which requires that compensation be
recorded each reporting period for changes in the fair value of
the Companys stock until the measurement date. The
measurement date is generally considered to be the date when all
services have been rendered or the date that options are fully
vested.
During 2007, 2006 and 2005, the Company recorded approximately
$290,000, $76,000 and $0 in employee stock-based compensation
expense and $3,000, $1,200 and $4,000 in non-employee
stock-based compensation expense, respectively.
F-64
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Determining the appropriate fair value model and the related
assumptions requires judgment. The fair value of each option
grant is estimated using the Black-Scholes-Merton option-pricing
model on the date of grant as follows:
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
2007
|
|
2006
|
|
2005
|
|
Estimated dividend yield
|
|
0.00%
|
|
0.00%
|
|
0.00%
|
Expected stock price volatility
|
|
68.00%
|
|
67.00%
|
|
75.00%
|
Risk-free interest rate
|
|
3.52 - 4.79
|
|
4.28 - 4.30
|
|
3.84 - 4.06
|
Expected life of option (in years)
|
|
6.04
|
|
5
|
|
10
|
Weighted-average fair value per share
|
|
$0.30
|
|
$0.06
|
|
$0.07
|
The computation of expected stock price volatility was based on
the historical volatility of a representative peer group of
three comparable companies selected based on publicly available
industry and market capitalization data. These companies were
Aspreva Pharamceuticals, Inc., Critical Therapeutics, Inc.
(Critical Therapeutics) and Oscient Pharmaceuticals
Corporation. The expected life represents the average time that
options that vest are expected to be outstanding. The expected
life of employee stock options is based on the mid-point between
the vesting date and the contractual term in accordance with the
simplified method prescribed in SAB No. 107,
Share-Based Payment, and the expected life for
stock-based compensation granted to non-employees is the
contractual life. The risk-free rate is based on the
U.S. Treasury yield curve during the expected life of the
option.
The Companys Board of Directors determines the fair value
at the time of issuance or grant of the Companys equity
instruments to employees and non-employees based upon the
consideration of factors that it deems to be relevant at the
time, including the Companys results of operations; its
available cash, assets and financial condition; its prospects
for growth; and positive or negative business developments since
the Board of Directors last determination of fair value.
Other
Charges
Other charges consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Settlement expenses (see Note 13)
|
|
$
|
245
|
|
|
$
|
1,679
|
|
|
|
|
|
Foregone merger costs (see Note 13)
|
|
|
|
|
|
|
240
|
|
|
|
|
|
Forfeiture of product rights (see Note 2
Product Rights)
|
|
|
|
|
|
|
1,662
|
|
|
$
|
1,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other charges
|
|
$
|
245
|
|
|
$
|
3,581
|
|
|
$
|
1,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
Taxes
Deferred income tax assets and liabilities are computed annually
for differences between the financial statement and tax bases of
assets and liabilities that will result in taxable or deductible
amounts in the future based on enacted tax laws and rates
applicable to the periods in which the differences are expected
to affect taxable income. Valuation allowances are established
when necessary to reduce deferred tax assets to the amounts
expected to be realized. Income tax expense is the tax payable
or refundable for the period plus or minus the change during the
period in deferred tax assets and liabilities.
F-65
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Fair
Value of Financial Instruments
The carrying amount of the Companys cash and cash
equivalents, receivables, accounts payable, line of credit and
license agreement liability approximate their fair values at
December 31, 2007 and 2006.
New
Accounting Pronouncements
In May 2008, the FASB issued SFAS No. 162, The
Hierarchy of Generally Accepted Accounting Principles
(SFAS 162). SFAS 162 identifies the
sources of accounting principles and the framework for selecting
the principles to be used in the preparation of financial
statements of nongovernmental entities that are presented in
conformity with GAAP (the GAAP hierarchy).
SFAS 162 makes the GAAP hierarchy explicitly and directly
applicable to preparers of financial statements, a step that
recognizes preparers responsibilities for selecting the
accounting principles for their financial statements, and sets
the stage for making the framework of FASB Concept Statements
fully authoritative. The effective date for SFAS 162 is
60 days following the SECs approval of the Public
Company Accounting Oversight Boards related amendments to
remove the GAAP hierarchy from auditing standards, where it has
resided for some time. The Company does not expect the adoption
of SFAS 162 to have a material impact on its financial
statements.
In April 2008, the FASB issued FASB Staff Position Financial
Accounting Standard
142-3,
Determination of the Useful Life of Intangible Assets
(FSP
FAS 142-3).
FSP
FAS 142-3
amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful
life of a recognized intangible asset under SFAS 142,
Goodwill and Other Intangible Assets. In developing
assumptions about renewal or extension, FSP
FAS 142-3
requires an entity to consider its own historical experience or,
if it has no experience, market participant assumptions,
adjusted for the entity-specific factors in paragraph 11 of
SFAS 142. FSP
FAS 142-3
expands the disclosure requirements of SFAS 142 and is
effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods
within those fiscal years, with early adoption prohibited. The
guidance for determining the useful life of a recognized
intangible asset must be applied prospectively to intangible
assets acquired after the effective date. The disclosure
requirements must be applied prospectively to all intangible
assets recognized as of, and subsequent to, the effective date.
The Company does not expect the adoption of FSP
FAS 142-3
to have a material impact on its financial statements.
In November 2007, the EITF issued EITF Issue
No. 07-01,
Accounting for Collaborative Arrangements
(EITF 07-01).
EITF 07-01
requires collaborators to present the results of activities for
which they act as the principal on a gross basis and report any
payments received from or made to other collaborators based on
other applicable generally accepted accounting principles or, in
the absence of other applicable generally accepted accounting
principles, based on analogy to authoritative accounting
literature or a reasonable, rational and consistently applied
accounting policy election.
EITF 07-01
is effective for fiscal years beginning after December 15,
2008. The Company does not expect the adoption of
EITF 07-01
to have a material impact on its financial statements.
In June 2007, the EITF issued EITF Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development
Activities
(EITF 07-3).
EITF 07-03
concludes that non-refundable advance payments for future
research and development activities should be deferred and
capitalized until the goods have been delivered or the related
services have been performed. If an entity does not expect the
goods to be delivered or services to be rendered, the
capitalized advance payments should be charged to expense.
EITF 07-3
is effective for fiscal years beginning after December 15,
2007. The initial adjustment to reflect the effect of applying
this EITF as a change in accounting principle is accounted for
as a cumulative-effect adjustment to retained earnings as of the
beginning of the year of adoption. The adoption of
EITF 07-03
did not have a material impact on the Companys financial
statements.
F-66
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In December 2007, the FASB issued SFAS No. 141(R),
Business Combinations (SFAS 141(R)).
SFAS 141(R) requires the acquiring entity in a business
combination to record all assets acquired and liabilities
assumed at their respective acquisition-date fair values and
changes other practices under SFAS No. 141, Business
Combinations, some of which could have a material impact on
how an entity accounts for its business combinations.
SFAS 141(R) also requires additional disclosure of
information surrounding a business combination so that users of
the entitys financial statements can fully understand the
nature and financial impact of the business combination.
SFAS 141(R) is effective for fiscal years beginning after
December 15, 2008 and is applied prospectively to business
combinations for which the acquisition date is on or after
January 1, 2009. The provisions of SFAS 141(R) will
only impact the Companys financial statements if the
Company is a party to a business combination after the effective
date of the pronouncement.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interest in Consolidated Financial
Statements an amendment of ARB No. 51
(SFAS 160). SFAS 160 requires entities
to report non-controlling minority interests in subsidiaries as
equity in consolidated financial statements. SFAS 160 is
effective for fiscal years beginning on or after
December 15, 2008. SFAS 160 is applied prospectively
as of the beginning of the fiscal year in which it is initially
applied, except for presentation and disclosure requirements,
which are applied retrospectively for all periods presented. The
Company does not expect the adoption of SFAS 160 to have a
material impact on its financial statements.
In February 2007, the FASB issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial
Liabilities, Including an Amendment of SFAS 115
(SFAS 159). SFAS 159 permits companies to
choose to measure many financial instruments and certain other
items at fair value. It also establishes presentation and
disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes
for similar types of assets and liabilities. SFAS 159
requires companies to provide additional information that will
help investors and other users of financial statements to more
easily understand the effect of a companys choice to use
fair value on its earnings. It also requires companies to
display the fair value of those assets and liabilities for which
they have chosen to use fair value on the face of the balance
sheet. SFAS 159 is effective for fiscal years beginning
after November 15, 2007 and interim periods within those
fiscal years. The Company was required to adopt SFAS 159 on
January 1, 2008. The adoption of SFAS 159 did not have
a material impact on the Companys financial statements.
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements (SFAS 157).
SFAS 157 defines fair value, establishes a framework for
measuring fair value in GAAP and expands disclosures about fair
value measurements. In February 2008, the FASB issued
FSP 157-2,
which defers the effective date of applying the provisions of
SFAS 157 to the fair value measurement of nonfinancial
assets and nonfinancial liabilities until fiscal years beginning
after November 15, 2008. The Company adopted the provisions
of SFAS 157 that pertain to financial assets and
liabilities on January 1, 2008. The adoption of
SFAS 157 did not have a material impact on the
Companys financial statements. The Company is currently
evaluating the effect
FSP 157-2
will have on its financial statements.
In July 2006, the FASB issued Interpretation No. 48,
Accounting for Uncertainty in Income Taxes an
interpretation of FASB Statement No. 109
(FIN 48). FIN 48 clarifies the
accounting for uncertainty in income taxes recognized in an
enterprises financial statements in accordance with
SFAS No. 109 and prescribes a recognition threshold
and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected
to be taken in a tax return. FIN 48 also provides guidance
on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition.
FIN 48 is effective for fiscal years beginning after
December 15, 2006. The adoption of FIN 48 did not have
a material impact on the Companys financial statements.
F-67
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
NOTE 2:
|
BALANCE
SHEET DATA
|
Accounts
Receivable
Accounts receivable consisted of the following as of December 31
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Trade accounts receivable
|
|
$
|
3,585
|
|
|
$
|
1,843
|
|
Royalties receivable
|
|
|
998
|
|
|
|
175
|
|
Other receivables
|
|
|
2,027
|
|
|
|
306
|
|
|
|
|
|
|
|
|
|
|
Total accounts receivable
|
|
|
6,610
|
|
|
|
2,324
|
|
|
|
|
|
|
|
|
|
|
Less allowance for discounts
|
|
|
(81
|
)
|
|
|
(44
|
)
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
$
|
6,529
|
|
|
$
|
2,280
|
|
|
|
|
|
|
|
|
|
|
Inventories
Inventories consisted of the following as of December 31
(thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Raw materials
|
|
$
|
1,564
|
|
|
$
|
468
|
|
Work in process
|
|
|
287
|
|
|
|
352
|
|
Finished goods:
|
|
|
|
|
|
|
|
|
Pharmaceutical products trade
|
|
|
625
|
|
|
|
569
|
|
Pharmaceutical products samples
|
|
|
723
|
|
|
|
558
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
3,199
|
|
|
|
1,947
|
|
|
|
|
|
|
|
|
|
|
Inventory allowances
|
|
|
(201
|
)
|
|
|
(100
|
)
|
|
|
|
|
|
|
|
|
|
Inventories, net
|
|
$
|
2,998
|
|
|
$
|
1,847
|
|
|
|
|
|
|
|
|
|
|
Property
and Equipment
Property and equipment consisted of the following as of December
31 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Computers and software
|
|
$
|
244
|
|
|
$
|
183
|
|
Machinery and equipment
|
|
|
6
|
|
|
|
6
|
|
Furniture and fixtures
|
|
|
114
|
|
|
|
112
|
|
Leasehold improvements
|
|
|
15
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
379
|
|
|
|
316
|
|
Less accumulated depreciation
|
|
|
(170
|
)
|
|
|
(99
|
)
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$
|
209
|
|
|
$
|
217
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for the years ended December 31, 2007,
2006 and 2005 was approximately $71,000, $58,000 and $52,000,
respectively.
F-68
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Product
Rights
Product rights consisted of the following as of December 31 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
BALACET®
product rights acquired from Vintage Pharmaceuticals, LLC
(Vintage)
|
|
$
|
7,549
|
|
|
$
|
7,549
|
|
SPECTRACEF®
product rights acquired through entry into a license agreement
with Meiji Seika Kaisha, Ltd. (Meiji)
|
|
|
4,505
|
|
|
|
1,940
|
|
Technology rights acquired from Neos Therapeutics, L.P.
(Neos)
|
|
|
500
|
|
|
|
500
|
|
ALLERX®
trademark acquired from Everton Pharmaceuticals, LLC
(Everton)
|
|
|
75
|
|
|
|
|
|
Total
|
|
|
12,629
|
|
|
|
9,989
|
|
Less accumulated amortization
|
|
|
(7,693
|
)
|
|
|
(4,533
|
)
|
|
|
|
|
|
|
|
|
|
Product rights, net
|
|
$
|
4,936
|
|
|
$
|
5,456
|
|
|
|
|
|
|
|
|
|
|
Amortization expense for the years ended December 31, 2007,
2006 and 2005 was approximately $3.2 million,
$2.6 million and $1.9 million, respectively. The
Company is amortizing the BALACET product rights over an
estimated useful life of three years, the SPECTRACEF product
rights over an estimated useful life of nine years and the
ALLERX trademark over an estimated useful life of four years.
The Company expects to begin amortizing the rights acquired from
Neos upon commercialization of the first product using these
rights, expected to be in 2009, over an estimated useful life of
15 years.
Future estimated amortization expense (excluding the rights
acquired from Neos) subsequent to December 31, 2007 is as
follows (in thousands):
|
|
|
|
|
2008
|
|
$
|
1,067
|
|
2009
|
|
|
438
|
|
2010
|
|
|
437
|
|
2011
|
|
|
426
|
|
2012
|
|
|
420
|
|
Thereafter
|
|
|
1,648
|
|
|
|
|
|
|
|
|
$
|
4,436
|
|
|
|
|
|
|
During the year ended December 31, 2006, the Company
entered into a settlement with Lupin Ltd. (see
Note 13) agreeing, among other things, to relinquish
all rights to a product license acquired from Lupin Ltd. The
forfeiture of the product rights of approximately
$1.7 million is included in other charges in the
accompanying consolidated statements of operations.
During the year ended December 31, 2005, the Company
entered into negotiations to purchase certain additional
U.S. pharmaceutical product rights by signing a term sheet
and making a $1.0 million nonrefundable standstill payment.
The payment allowed the Company to preserve and extend its
rights to purchase a trademark that was to be used upon the
launch of an extended-release cephalexin product. When this
project was abandoned by the Companys management at the
end of 2005, the trademark was no longer necessary, and the
Company therefore forfeited the standstill payment. The
forfeiture of the standstill payment is included in other
charges in the accompanying consolidated statements of
operations.
F-69
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Accrued
Expenses
Accrued expenses consisted of the following as of December 31
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Accrued returns
|
|
$
|
4,913
|
|
|
$
|
5,781
|
|
Accrued rebates
|
|
|
303
|
|
|
|
140
|
|
Accrued other sales allowances
|
|
|
828
|
|
|
|
687
|
|
Accrued compensation and benefits
|
|
|
1,596
|
|
|
|
1,318
|
|
Accrued royalties
|
|
|
1,940
|
|
|
|
484
|
|
Accrued interest, affiliate
|
|
|
1,490
|
|
|
|
549
|
|
Accrued interest
|
|
|
71
|
|
|
|
34
|
|
Accrued expenses, other
|
|
|
22
|
|
|
|
9
|
|
Accrued arbitration settlement expenses (see Note 13)
|
|
|
|
|
|
|
1,140
|
|
|
|
|
|
|
|
|
|
|
Total accrued expenses
|
|
$
|
11,163
|
|
|
$
|
10,142
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 3:
|
LICENSE
AGREEMENT LIABILITY
|
On October 12, 2006, the Company entered into a license and
supply agreement with Meiji granting the Company an exclusive,
nonassignable U.S. license to manufacture and sell a
200 mg dosage of SPECTRACEF, using cefditoren pivoxil
supplied by Meiji. In consideration for the license, the Company
agreed to pay Meiji a nonrefundable license fee of
$6.0 million in six installments over a period of five
years from the date of the agreement. The agreement provided
that if a generic cefditoren product was launched in the United
States prior to October 12, 2011, the Company would be
released from its obligation to make any further license fee
payments due after the date of launch. In 2006, the Company
estimated that a generic active agreement would be available in
two and a half years, which would limit the total installment
payments to $2.25 million.
On July 27, 2007, the Company entered into an amendment to
the license and supply agreement and a letter agreement
supplementing the license and supply agreement. The amendment to
the license and supply agreement extended the Companys
rights under the agreement to additional products and additional
therapeutic indications of products containing cefditoren
pivoxil supplied by Meiji that are jointly developed by Meiji
and the Company and which Meiji and the Company agree to have
covered by the agreement. The letter agreement provides that if
the Company successfully launches a 400 mg product (SPECTRACEF
400 mg), a once-daily product (SPECTRACEF Once Daily)
and/or a
pediatric product (SPECTRACEF Suspension) and sales of these
products substantially lessen the generic products adverse
effect on SPECTRACEF sales, the Company will be required to
continue paying Meiji a reasonable amount of the license fee as
mutually agreed by the parties. Therefore, in 2007, the Company
revised its estimate of payments to include the full
$6.0 million in installments over five years since October
2006.
The license and supply agreement also requires the Company to
make quarterly royalty payments based on the net sales of the
cefditoren pivoxil products covered by the agreement. The
Company is required to make these payments for a period of ten
years from the date it launches a particular product.
The license agreement liability consists of the following as of
December 31 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
License agreement liability to Meiji; imputed interest at 12%
per annum; principal and interest payable for the remaining four
years
|
|
$
|
3,535
|
|
|
$
|
1,690
|
|
Less current portion
|
|
|
(576
|
)
|
|
|
(720
|
)
|
|
|
|
|
|
|
|
|
|
Long-term
|
|
$
|
2,959
|
|
|
$
|
970
|
|
|
|
|
|
|
|
|
|
|
F-70
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Principal maturities of the license agreement liability
subsequent to December 31, 2007 are as follows
(in thousands):
|
|
|
|
|
2008
|
|
$
|
576
|
|
2009
|
|
|
645
|
|
2010
|
|
|
972
|
|
2011
|
|
|
1,342
|
|
|
|
|
|
|
Total
|
|
$
|
3,535
|
|
|
|
|
|
|
In April 2005, the Company obtained financing under a bank line
of credit for up to $4.0 million, subject to a monthly
borrowing base equal to 75% of accounts receivable balances
outstanding 90 days or less and 50% of inventories.
Interest is due monthly with all outstanding principal and
interest due on maturity. The initial maturity of the line of
credit was April 2006. The line of credit was modified in April
2006 to, among other things, extend its maturity to April 2007.
The line of credit was modified again in July 2007 to, among
other things, extend its maturity to June 2008.
The line of credit requires the Carolina Note (as defined in
Note 5) to be subordinated to the line of credit; the
Company to not incur any additional debt without the
lenders consent; the Companys President and Chief
Executive Officer to maintain a certain level of liquid assets
in the Company; and the Companys President and Chief
Executive Officer and Carolina Pharmaceuticals, Inc., an entity
under common control with the Company, to jointly guarantee the
line of credit. Amounts outstanding under the line of credit
bear interest at a variable rate equal to the Wall Street
Journal prime rate, which was 7.25% as of December 31,
2007. There was a $1.75 million outstanding balance on and
$2.25 million of borrowing availability under the line of
credit as of December 31, 2007 and 2006.
As of December 31, 2007, the line of credit was
collateralized by the Companys accounts receivable,
inventories, intangible assets and other personal property; a
$2.0 million deed of trust on the personal residence of the
Companys President and Chief Executive Officer; and an
assignment of deposits in the amount of $1.0 million to the
Company by the Companys President and Chief Executive
Officer. The line of credit also required the Companys
President and Chief Executive Officer to maintain at least a 48%
ownership interest in the Company.
The Company was in violation of one of the covenants under the
line of credit in 2005 and 2006. The bank waived these
violations, and this covenant was removed from the line of
credit in July 2007.
In June 2008, the Company modified the line of credit. The
modification agreement extended the line of credits
maturity date to June 2009, required the Companys
President and Chief Executive Officer to maintain a majority
ownership in the Company and added Cornerstone BioPharma, Inc.
and Aristos Pharmaceuticals, Inc. as joint guarantors of the
line of credit. The modification agreement also revised the
collateral for the line of credit to include assets held by
Cornerstone BioPharma, Inc. and Aristos Pharmaceuticals, Inc.
and reduced the $1.0 million assignment of deposits from
the Companys President and Chief Executive Officer to a
$500,000 assignment of deposits. Finally, the modification
agreement revised the monthly borrowing base by eliminating the
inventory component of the borrowing base and including in the
borrowing base accounts receivable held by Cornerstone
BioPharma, Inc. and Aristos Pharmaceuticals, Inc. and the
$500,000 cash deposited by the Companys President and
Chief Executive Officer.
F-71
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Carolina
Note
In April 2004, the Company executed a promissory note with
Carolina Pharmaceuticals Ltd. (Carolina
Pharmaceuticals), an entity under common control with the
Company, to borrow up to $15.0 million for five years with
an annual interest rate of 10% (Carolina Note). The
Company borrowed $13.0 million under the Carolina Note in
April 2004. In June 2006, the Company and Carolina
Pharmaceuticals agreed to offset approximately $3.6 million
in principal and $1.8 million in accrued interest
outstanding under the Carolina Note against equal amounts due to
the Company from a related party.
As of December 31, 2007 and 2006, approximately
$9.4 million in principal was outstanding under this
agreement plus approximately $1.5 million and $549,000 in
accrued interest, respectively. The outstanding principal and
accrued interest are due in 2009.
Vintage
Note
In July 2004, the Company purchased the rights to two products
from Vintage for an upfront payment of $5.0 million, a note
payable of $3.0 million and ongoing quarterly royalty
payments equal to a percentage of the products net sales.
The note, which was collateralized by the product rights
purchased, had an interest rate of 2.5% and was to be paid in
two installments of $1.5 million on January 15, 2005
and July 15, 2005. The Company imputed interest at a rate
of 18%, which yielded an original issue discount of
approximately $450,000. This discount was amortized over the
life of the note, beginning in July 2004. Amortization of the
discount in 2005 was approximately $330,000. The discount was
fully amortized as of December 31, 2005.
In May 2005, the note was amended to extend the maturity date
for the January 15, 2005 installment to August 1, 2005
and the July 15, 2005 maturity date to November 1,
2005. In November 2005, the note was further amended to extend
the payment date for the November 1, 2005 installment of
$1.5 million to February 1, 2006 and to change the
interest rate to 5.0% beginning November 1, 2005. The
Company paid the note payable in full in February 2006.
|
|
NOTE 6:
|
STOCKHOLDERS
DEFICIT
|
As of December 31, 2007, 2006 and 2005, Cornerstone
BioPharma Holdings, Inc. was authorized to issue
50,000,000 shares of common stock, par value $0.0001. As of
December 31, 2007, the Company had outstanding
24,926,150 shares of $0.0001 par value common stock.
In May 2005, in connection with the corporate restructuring (the
Restructuring) of Cornerstone BioPharma Holdings,
Inc., the common stockholders and the common stock option
holders of an affiliated company, Cornerstone Biopharma
Holdings, Ltd., with the exception of its chief executive
officer, cancelled their shares of stock and stock options in
that company. Cornerstone Biopharma Holdings, Ltd. cancelled the
outstanding shares of its common stock except for the
13,450,000 shares held by its chief executive officer.
Cornerstone Biopharma Holdings, Ltd. does not currently engage
in any operating activities; it only engages in investment
activities.
In connection with the Restructuring, on May 15, 2005,
Cornerstone BioPharma Holdings, Inc. sold and issued
11,750,000 shares of its common stock, at a price of
$0.0001 per share, to those individuals and entities whose
common shares of Cornerstone Biopharma Holdings, Ltd. had
previously been cancelled. Persons whose shares in Cornerstone
Biopharma Holdings, Ltd. were cancelled received an equal number
of shares of common stock of Cornerstone BioPharma Holdings,
Inc. In addition, Cornerstone Biopharma Holdings, Ltd. exchanged
all of its shares of Cornerstone Biopharma, Ltd. and Cornerstone
BioPharma, Inc. for 13,450,000 shares of Cornerstone
BioPharma Holdings, Inc.
F-72
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Stock
Issued to Directors
Also in connection with the Restructuring in 2005, Cornerstone
BioPharma Holdings, Inc. sold and issued 200,000 additional
shares of its common stock at a price of $0.0001 to two of its
directors as compensation for their service on its board. The
Company has included compensation expense of approximately
$20,000 for the value of these shares in excess of their
purchase price.
Restricted
Common Stock
The Company required certain employees to enter into employment
agreements and stock purchase agreements, as subsequently
amended, that would allow them to vest in their stock over time.
The stock vests 25% annually. The Company has the right to
purchase the unvested portion of the restricted common stock on
termination of employment for the original purchase price per
share.
The following summarizes the restricted stock activity for the
years ended December 31, 2007, 2006 and 2005:
|
|
|
|
|
|
|
Number of
|
|
|
Restricted Shares
|
|
|
Outstanding
|
|
Nonvested as of December 31, 2004
|
|
|
1,607,500
|
|
Vested
|
|
|
(401,875
|
)
|
Redeemed
|
|
|
|
|
|
|
|
|
|
Nonvested as of December 31, 2005
|
|
|
1,205,625
|
|
Vested
|
|
|
(401,875
|
)
|
Redeemed
|
|
|
(375,000
|
)
|
|
|
|
|
|
Nonvested as of December 31, 2006
|
|
|
428,750
|
|
Vested
|
|
|
(214,375
|
)
|
Redeemed
|
|
|
|
|
|
|
|
|
|
Nonvested as of December 31, 2007
|
|
|
214,375
|
|
|
|
|
|
|
Warrants
to Purchase Common Stock
In February 2006, the Company issued a warrant to purchase
15,000 shares of common stock at $0.10 per share in
exchange for services. The warrant was valued at $2,000 and is
exercisable for a ten-year period from the date of grant. The
fair value of the warrant granted was estimated on the date of
grant using the Black-Scholes-Merton pricing model with the
following assumptions: dividend yield of 0%, expected volatility
of 157%, risk-free interest rate of 4.51% and expected life of
ten years.
In July 2004, Cornerstone Biopharma Holdings, Ltd. issued an
option to purchase 5% of its common shares to a company owned by
a former stockholder of an affiliated company in connection with
a license agreement. The option had an exercise price of
$100,000, had an exercise period that extended through
December 31, 2009 and was exercisable for such number of
shares that would give the optionholder a 5% ownership interest
in Cornerstone Biopharma Holdings, Ltd.s issued and
outstanding shares following the exercise. The fair value of the
option was approximately $48,000. In connection with the
Restructuring, in July 2006, the option was cancelled and
replaced with a warrant exercisable on the same terms but for
shares in the Company. The Company did not record any additional
compensation expense in 2006 when it issued the warrant because
the fair value of the warrant was the same as the fair value of
the option that it replaced. In April 2007, the Company amended
the warrant to, among other things, decrease its exercise price
to $50,000 and extend its
F-73
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
exercise period through December 31, 2010. In 2007, the
Company recorded approximately $508,000 of compensation expense
due to the amendment of the warrant.
In June 2005, the Company issued two warrants to purchase
10,000 shares each of common stock of at $0.10 per share in
exchange for services. The warrants were valued at $2,000 and
are exercisable for a ten-year period from the date of grant.
The fair value of the warrants granted was estimated on the date
of grant using the Black-Scholes-Merton pricing model with the
following assumptions: dividend yield of 0%, expected volatility
of 75%, risk-free interest rate of 3.91% and expected life of
ten years.
In May 2005, the Company adopted the Cornerstone BioPharma
Holdings, Inc. 2005 Stock Option Plan (the Old Stock
Plan), which provided for the award of stock options to
purchase up to 10,000,000 shares of the Companys
common stock to employees, directors and consultants of the
Company. Initial awards were made under the Old Stock Plan that
were not properly authorized by the Companys Board of
Directors, which determined to ratify the awards and replace
them with awards under the Cornerstone BioPharma Holdings, Inc.
2005 Stock Incentive Plan (the New Stock Plan),
which had been established by the Board of Directors and which
provided for the granting of up to 10,000,000 stock options to
employees, directors and consultants of the Company. At its
December 23, 2005 meeting, the Board of Directors directed
the officers of the Company to seek the agreement of awardees to
cancel the grants under the Old Stock Plan and to replace such
grants with stock options under the New Stock Plan. Thus, the
Board of Directors intended to replace the Old Stock Plan with
the New Stock Plan and to eliminate the available option pool
under the Old Stock Plan. Despite the Board of Directors
intention to replace the Old Stock Plan, the Company did not
secure the consent of all optionees to terminate the awards
under the Old Stock Plan and stock options exercisable for an
aggregate of 272,500 shares of common stock remained
outstanding under the Old Stock Plan as of December 31,
2007. All stock option awards subsequent to the adoption of the
New Stock Plan have been awarded under the New Stock Plan.
The Board of Directors shall determine the exercise price, term
and dates of the exercise of all options at their grant date.
The Board of Directors determines the fair market value of the
common stock. Under the Old Stock Plan and the New Stock Plan,
options become vested over variable periods and expire not more
than ten years after the date of grant.
The following table summarizes the stock option activity for the
years ended December 31, 2005, 2006 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available
|
|
Granted
|
|
Weighted-
|
|
|
Option
|
|
Options
|
|
Average
|
|
|
Shares
|
|
Outstanding
|
|
Exercise Price
|
|
Exchanged in the Restructuring
|
|
|
|
(1)
|
|
|
602,500
|
(1)
|
|
$
|
0.16
|
|
Adoption of 2005 Stock Incentive Plan
|
|
|
10,000,000
|
|
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2005
|
|
|
10,000,000
|
|
|
|
602,500
|
|
|
|
0.16
|
|
Granted
|
|
|
(2,855,531
|
)
|
|
|
2,855,531
|
|
|
|
0.10
|
|
Exercised
|
|
|
|
|
|
|
(101,150
|
)
|
|
|
0.10
|
|
Cancelled
|
|
|
488,659
|
|
|
|
(488,659
|
)
|
|
|
0.12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2006
|
|
|
7,633,128
|
|
|
|
2,868,222
|
|
|
|
0.11
|
|
Granted
|
|
|
(4,767,500
|
)
|
|
|
4,767,500
|
|
|
|
0.43
|
|
Cancelled
|
|
|
30,884
|
|
|
|
(30,884
|
)
|
|
|
0.15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2007
|
|
|
2,896,512
|
|
|
|
7,604,838
|
|
|
$
|
0.31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-74
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
(1) |
|
Option pool reduced from 10,000,000 shares to
602,500 shares which is the aggregate number of shares that
had been granted under the Old Stock Plan prior to the Board of
Directors action creating the New Stock Plan on
December 23, 2005. |
The following table summarizes by grant date the Companys
grants of equity instruments issued during the years ended
December 31, 2005, 2006 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
|
|
|
|
|
|
|
|
|
Intrinsic Value
|
|
|
|
|
Equity
|
|
of Equity
|
|
|
|
|
|
Fair Value of
|
|
|
of Equity
|
|
Grant
|
|
|
Instruments
|
|
Instruments
|
|
|
Exercise
|
|
|
Common Stock at
|
|
|
Instruments
|
|
Date
|
|
|
Granted
|
|
Granted
|
|
|
Price
|
|
|
Grant Date
|
|
|
at Grant Date
|
|
|
|
7/1/2005
|
|
|
Stock Options
|
|
|
367,500
|
|
|
$
|
0.10
|
|
|
$
|
0.10
|
|
|
$
|
|
|
|
7/1/2005
|
|
|
Stock Options
|
|
|
235,000
|
|
|
|
0.25
|
|
|
|
0.25
|
|
|
|
|
|
|
1/17/2006
|
|
|
Stock Options
|
|
|
1,477,700
|
|
|
|
0.10
|
|
|
|
0.10
|
|
|
|
|
|
|
2/1/2006
|
|
|
Stock Options
|
|
|
30,000
|
|
|
|
0.10
|
|
|
|
0.10
|
|
|
|
|
|
|
2/8/2006
|
|
|
Stock Options
|
|
|
825,000
|
|
|
|
0.10
|
|
|
|
0.10
|
|
|
|
|
|
|
2/23/2006
|
|
|
Stock Options
|
|
|
522,831
|
|
|
|
0.10
|
|
|
|
0.10
|
|
|
|
|
|
|
3/16/2007
|
|
|
Stock Options
|
|
|
4,475,000
|
|
|
|
0.42
|
|
|
|
0.42
|
|
|
|
|
|
|
5/24/2007
|
|
|
Stock Options
|
|
|
66,500
|
|
|
|
0.42
|
|
|
|
0.42
|
|
|
|
|
|
|
9/14/2007
|
|
|
Stock Options
|
|
|
126,000
|
|
|
|
0.48
|
|
|
|
0.48
|
|
|
|
|
|
|
12/5/2007
|
|
|
Stock Options
|
|
|
100,000
|
|
|
|
0.48
|
|
|
|
0.48
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Stock Options
|
|
|
8,225,531
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5/15/2005
|
|
|
Warrants
|
|
|
1,746,405
|
|
|
$
|
0.01
|
|
|
$
|
0.10
|
|
|
$
|
157,000
|
|
|
6/15/2005
|
|
|
Warrants
|
|
|
20,000
|
|
|
|
0.10
|
|
|
|
0.10
|
|
|
|
|
|
|
2/1/2006
|
|
|
Warrants
|
|
|
15,000
|
|
|
|
0.10
|
|
|
|
0.10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Warrants
|
|
|
1,781,405
|
|
|
|
|
|
|
|
|
|
|
$
|
157,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2007, the aggregate intrinsic value of
options outstanding was $1,327,528 and the aggregate intrinsic
value of options exercisable was $627,890. The intrinsic value
of options exercised during the year ended December 31,
2006 was $0. There were no options exercised during the years
ended December 31, 2005 and 2007.
The following table summarizes the stock options vested and
expected to vest as of December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average
|
|
|
|
|
|
|
Remaining
|
|
|
|
|
Number
|
|
Contractual Life
|
|
Weighted-Average
|
|
|
of Options
|
|
(In Years)
|
|
Exercise Price
|
|
Outstanding
|
|
|
7,604,838
|
|
|
|
8.79
|
|
|
$
|
0.31
|
|
Exercisable
|
|
|
1,707,387
|
|
|
|
8.02
|
|
|
|
0.11
|
|
F-75
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes information about the
Companys stock options as of December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
Average
|
|
|
|
|
Options
|
|
Contractual Life
|
|
Options
|
Exercise Price
|
|
Outstanding
|
|
(Years)
|
|
Exercisable
|
|
$
|
0.10
|
|
|
|
2,677,338
|
|
|
|
8.06
|
|
|
|
1,569,637
|
|
|
0.25
|
|
|
|
165,000
|
|
|
|
7.50
|
|
|
|
136,250
|
|
|
0.42
|
|
|
|
4,536,500
|
|
|
|
9.21
|
|
|
|
1,500
|
|
|
0.48
|
|
|
|
226,000
|
|
|
|
9.80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,604,838
|
|
|
|
|
|
|
|
1,707,387
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2007 and 2006, there was approximately
$1,077,000 and $96,000 of total unrecognized compensation cost
related to nonvested stock-based compensation arrangements,
which is expected to be recognized over a weighted-average
period of 3.06 and 2.92 years, respectively.
|
|
NOTE 8:
|
NET
INCOME (LOSS) PER SHARE
|
The Company computes net income (loss) per share in accordance
with SFAS No. 128, Earnings Per Share
(SFAS 128). Under the provisions of
SFAS 128, basic net income (loss) per share is computed by
dividing net income (loss) by the weighted-average number of
common shares outstanding. Diluted net income (loss) per share
is computed by dividing net income (loss) by the
weighted-average number of common shares and dilutive common
share equivalents then outstanding. Common share equivalents
consist of the incremental common shares issuable upon the
exercise of stock options and the impact of vested restricted
stock grants.
The following table reconciles the numerator and denominator
used to calculate diluted net income (loss) per share (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
570
|
|
|
$
|
(305
|
)
|
|
$
|
(11,438
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares, basic
|
|
|
24,926,150
|
|
|
|
25,022,594
|
|
|
|
25,126,027
|
|
Dilutive effect of stock options and warrants
|
|
|
3,429,983
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares, diluted
|
|
|
28,356,133
|
|
|
|
25,022,594
|
|
|
|
25,126,027
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended 2007, 2006 and 2005, there were zero,
3,662,790 and 2,507,219, respectively, potential common shares
outstanding that were excluded from the diluted net income
(loss) per share calculation because their effect would have
been anti-dilutive.
Operating
Leases
The Company leases its facilities and certain equipment and
automobiles under noncancelable operating leases expiring at
various dates through 2010. Rent expense was approximately
$466,000, $559,000 and $486,000 for the years ended
December 31, 2007, 2006 and 2005, respectively.
F-76
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Future minimum payments under non-cancelable operating leases
with initial terms of one year or more consist of the following
as of December 31, 2007 (in thousands):
|
|
|
|
|
2008
|
|
$
|
262
|
|
2009
|
|
|
60
|
|
2010
|
|
|
11
|
|
|
|
|
|
|
Total minimum lease payments
|
|
$
|
333
|
|
|
|
|
|
|
|
|
NOTE 10:
|
EMPLOYEE
BENEFIT PLANS
|
In 2004, the Company implemented a defined benefit pension plan
for certain employees. The plan required the Company to pay
premiums on individual insurance contracts to fund the benefits
provided by the plan. The plan assets were invested in life
insurance policies in the names of each of the participants. The
Company contributed approximately $52,000 and
$194,000 to the plan for the years ended December 31,
2006 and 2005. In 2006, the plan was terminated and all of its
assets were distributed.
In 2004, the Company implemented a profit-sharing plan that was
subject to the provisions of the Employee Retirement Income
Security Act of 1974. Participants of the defined benefit
pension plan were not eligible to participate in the
profit-sharing plan. The Company was required to fund the plan
in an amount equal to 7.5% of the participants
compensation for the plan year. For the years ended
December 31, 2006 and 2005, there were funding requirements
of approximately $82,000 and $41,000, respectively. The Company
terminated the profit-sharing plan in 2006. As of
December 31, 2006, the Company had not made any
contributions to this plan. The Company accrued a liability of
$138,000 and $23,000 as of December 31, 2006 and 2005,
respectively, for the contributions. The Company paid $138,000
in 2007 to settle the liability.
The Company established a qualified 401(k) plan, effective
January 1, 2005, covering all employees who are least
21 years of age. The Companys employees may elect to
make contributions to the plan within statutory and plan limits,
and the Company may elect to make matching or voluntary
contributions. As of December 31, 2007, the Company had not
made any contributions to the 401(k) plan. The Company incurred
approximately $4,000, $8,000 and $2,000 of expenses related to
the plan for the years ended December 31, 2007, 2006 and
2005, respectively.
As discussed in Note 1, the Companys consolidated
financial statements include the accounts of Cornerstone
BioPharma Holdings, Inc., Cornerstone BioPharma, Inc.,
Cornerstone Biopharma, Ltd., and Aristos Pharmaceuticals, Inc.
Cornerstone Biopharma, Ltd. is an Anguilla international
business company and was taxed as a foreign corporation for
U.S. tax purposes in 2007 and 2006. Because Cornerstone
Biopharma, Ltd. is not subject to income tax in Anguilla, the
Companys consolidated financial statements do not include
a provision for income taxes for this entity. Cornerstone
Biopharma, Ltd.s income would have been taxed to the owner
of Cornerstone BioPharma Holdings, Inc. if Cornerstone
Biopharma, Ltd. had issued dividends to Cornerstone BioPharma
Holdings, Inc. or if Cornerstone BioPharma Holdings, Inc. had
sold the stock of this subsidiary.
F-77
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The provision for income taxes includes the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
Current:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
62
|
|
|
$
|
|
|
|
$
|
|
|
State
|
|
|
68
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
|
|
|
|
|
|
|
|
|
|
State
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total tax provision
|
|
$
|
130
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income taxes reflect the net tax effects of temporary
differences between the carrying amounts of assets and
liabilities for financial reporting purposes and the amounts
used for income tax purposes. Significant components of the
Companys deferred tax assets as of December 31 are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Current:
|
|
|
|
|
|
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
$
|
31
|
|
|
$
|
16
|
|
Allowance for doubtful accounts
|
|
|
|
|
|
|
|
|
Inventories, net
|
|
|
177
|
|
|
|
38
|
|
Accrued expenses
|
|
|
2,881
|
|
|
|
2,830
|
|
Valuation allowance
|
|
|
(3,089
|
)
|
|
|
(2,884
|
)
|
|
|
|
|
|
|
|
|
|
Total current deferred tax assets
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
F-78
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
Noncurrent:
|
|
|
|
|
|
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Tax loss carryforwards
|
|
$
|
656
|
|
|
$
|
1,548
|
|
Contribution carryforwards
|
|
|
|
|
|
|
36
|
|
Deferred compensation
|
|
|
203
|
|
|
|
12
|
|
Warrants
|
|
|
|
|
|
|
1
|
|
Product license rights, net
|
|
|
244
|
|
|
|
115
|
|
Organizational costs, net
|
|
|
2
|
|
|
|
4
|
|
Tax credits
|
|
|
62
|
|
|
|
|
|
Valuation allowance
|
|
|
(1,143
|
)
|
|
|
(1,691
|
)
|
|
|
|
|
|
|
|
|
|
Total noncurrent deferred tax assets
|
|
|
24
|
|
|
|
25
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
24
|
|
|
|
25
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax asset noncurrent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net deferred tax asset
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes computed at the statutory federal income tax rate
of 34% are reconciled to the provision for income taxes as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
United States federal tax at statutory rate
|
|
$
|
238
|
|
|
$
|
(177
|
)
|
|
$
|
(3,880
|
)
|
State taxes (net of federal benefit)
|
|
|
30
|
|
|
|
(19
|
)
|
|
|
(428
|
)
|
Nondeductible expenses
|
|
|
237
|
|
|
|
84
|
|
|
|
109
|
|
Carryback net operating losses to 2004
|
|
|
|
|
|
|
|
|
|
|
75
|
|
Other
|
|
|
(32
|
)
|
|
|
(4
|
)
|
|
|
|
|
Increase in valuation allowance
|
|
|
(343
|
)
|
|
|
116
|
|
|
|
4,124
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes
|
|
$
|
130
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company has established a valuation allowance against its
deferred tax assets due to the uncertainty surrounding the
realization of such assets.
As of December 31, 2007, the Company has federal net
operating loss carryforwards of approximately $1.7 million
that expire beginning in the year 2025 as well as state tax net
economic loss carryforwards of approximately $1.9 million
that expire beginning in 2020. The Company recognized
approximately $820,000 in tax benefits in 2007 related to net
operating loss carryforwards.
The Tax Reform Act of 1986 contains provisions that limit the
Companys ability to utilize the net operating loss
carryforwards in the case of certain events, including
significant changes in ownership interests. If the
Companys net operating loss carryforwards are limited and
the Company has taxable income that exceeds the permissible
yearly net operating loss carryforwards, the Company would incur
a federal income tax liability even though net operating loss
carryforwards would be available in future years.
F-79
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
NOTE 12:
|
RELATED
PARTY TRANSACTIONS
|
Stockholders
In 2005, the Company obtained legal services from a stockholder
and former director of the Company in the amount of
approximately $88,000. No such services were obtained in 2006 or
2007.
During 2007, 2006 and 2005, the Company made advances to its
President and Chief Executive Officer, who is also the
Companys majority stockholder, of approximately $615,000,
$1.1 million and $946,000, respectively. The President and
Chief Executive Officer repaid all 2005 advances by
December 31, 2005. As of December 31, 2007 and 2006,
unpaid advances were approximately $648,000 and $35,000,
respectively, and are included in amounts due from related
parties as of those dates.
The Company has certain agreements with its President and Chief
Executive Officer that provide certain benefits related to a
qualified termination or change of control, as defined by the
agreements.
Other
Related Parties
As of December 31, 2007 and 2006, the Company owes Carolina
Pharmaceuticals approximately $260,000 in accrued royalties
related to the sale of
Humibid®
and
DECONSAL®.
This amount is included in accrued royalties as disclosed in
Note 2. The Company paid $750,000 to Carolina
Pharmaceuticals for royalties in 2006. The Company did not pay
any royalties to Carolina Pharmaceuticals in 2005 or 2007. The
Companys President and Chief Executive Officer is the
Chief Executive Officer and Chairman of the Board of Carolina
Pharmaceuticals and certain other executive officers of the
Company are directors of Carolina Pharmaceuticals.
In 2005, the Company purchased DECONSAL II inventory samples
from Carolina Pharmaceuticals for approximately $109,000.
Accounts payable of $0 and approximately $49,000 related to this
purchase were outstanding as of December 31, 2007 and 2006,
respectively.
In May 2005, the Company licensed certain product rights to
Auriga Laboratories, Inc. (Auriga), which is also
owned in part
and/or
directed by some of the Companys stockholders. The
effective date of the agreement is August 1, 2005. The
Company received a royalty ranging from 8% to 30% of net sales,
depending on the level of net sales. The Companys royalty
is not to exceed $1.7 million on an annual basis. Auriga
assumed responsibility for royalty payments to the previous
owner of the product rights as of the effective date. In 2006,
the royalty agreement with Auriga was amended to reduce the
royalty rates from 30% to 5% of net sales in a specific calendar
quarter. The amendment also provided for Auriga to issue the
Company 200,000 shares of its common stock. The fair value
of the stock, determined as the trading price on date of grant
discounted 15% for lack of marketability due to a one-year lock
up period, was approximately $332,000. As discussed in
Note 1, the Company included this amount in royalty
agreement revenues.
The Company recognized royalty agreement revenues under the
agreements with Auriga of approximately $58,000, $552,000 and
$511,000 for the years ended December 31. 2007, 2006 and
2005, respectively. The Company recorded approximately $56,000
in accounts payable as of December 31, 2007 due to returns
processed against royalties in 2007. The Company recorded a
royalty receivable under the agreement of approximately $117,000
as of December 31, 2006, which is included in amounts due
from related parties.
|
|
NOTE 13:
|
CONTRACTUAL
AGREEMENTS AND OBLIGATIONS
|
Royalties
The Company has contractual obligations to pay royalties to the
former owners of certain product rights that have been acquired
by or licensed to the Company. These royalties are based on a
percentage of net sales of the particular licensed product.
F-80
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In August 2006, the Company entered into an agreement with
Pharmaceutical Innovations, LLC (Pharmaceutical
Innovations) for an exclusive license to a
U.S. patent and know-how to manufacture, package, market
and distribute various day-night products. In exchange for these
rights, the Company was required to pay Pharmaceutical
Innovations a special royalty of 8.5% of initial net sales of
day-night products up to a total of $250,000. The Company paid
this special royalty in 2006 and 2007. In addition, the Company
is obligated to pay royalties based on a percentage of the
products annual net sales. The royalty rate increases as
the annual net sales increase. Minimum annual royalties are
$300,000 per year under this agreement during the life of the
licensed patent based on the products currently marketed by the
Company.
Inventory
Purchases
The Company purchases inventory from pharmaceutical
manufacturers. During the year ended December 31, 2007, one
vendor accounted for 23% of the Companys inventory
purchases. During the years ended December 31, 2006, and
2005, two vendors accounted for 22% and 25%, respectively, of
the Companys inventory purchases. Three vendors accounted
for 37% of the Companys accounts payable as of
December 31, 2007. Two vendors accounted for 42% of the
Companys accounts payable as of December 31, 2006.
The Company has entered into an agreement with Vintage to
exclusively manufacture two prescription pain products acquired
from Vintage for prices established by the agreement, subject to
renegotiation at each anniversary date. The agreement expires in
July 2009 and may be renewed for subsequent one-year terms.
In connection with the license agreement with Meiji as described
in Note 3, the Company also entered into a supply agreement
with Meiji to purchase minimum quantities of cefditoren pivoxil,
the API in SPECTRACEF, exclusively from Meiji. Under this
agreement, Cornerstone is required to purchase the minimum
quantities of cefditoren pivoxil necessary to support targeted
gross sales of SPECTRACEF after the SPECTRACEF product launch of
$8.0 million for year one, $11.0 million for year two,
$13.0 million for year three, $17.0 million for year
four and $24.0 million for year five. If the Company does
not meet its minimum purchase requirement in a given year, the
Company must pay Meiji an amount equal to 50% of the shortfall
in that year. The Company expects to exceed the minimum purchase
requirements.
In July 2007, the Company entered into a supply agreement with
Bayer HealthCare, LLC (Bayer) to purchase minimum
quantities of the bulk tablets for the ALLERX Dose Pack family
of products from Bayer during calendar years 2008 and 2009. An
additional one-time cost of up to $135,000 will be due on
December 31, 2009 if the Company fails to meet the minimum
annual purchase requirement of 27.0 million tablets per
year for 2008 and 2009. The Company expects to exceed the
minimum purchase requirements.
As of December 31, 2007 and 2006, the Company had
outstanding purchase commitments related to inventory totaling
approximately $2.8 million and $392,000, respectively.
Co-promotion
Agreements
In February 2006, the Company signed a co-promotion agreement
with Ascend Therapeutics, Inc. (Ascend) to provide
detailing of a product to a specific physician population. As
compensation, the Company paid a fee for detailing the product
equal to 50% of net sales. This agreement was terminated in
March 2008.
In March 2007 and June 2007, the Company entered into
co-promotion agreements with SJ Pharmaceuticals, LLC (SJ
Pharmaceuticals) to co-promote two of the Companys
product lines. Under these agreements, the Company pays SJ
Pharmaceuticals fees based on a percentage of the net profits of
the products sold above a specified baseline based upon
prescriptions by assigned, targeted prescribers within assigned
sales territories. These targeted prescribers are mutually
agreed upon by the Company and SJ Pharmaceuticals prior to the
start of each quarter.
F-81
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In April 2007, the Company entered into a co-promotion agreement
with Atley Pharmaceuticals, Inc. (Atley
Pharmaceuticals) to co-promote a prescription pain product
beginning July 1, 2007. Under the agreement, the Company
pays Atley Pharmaceuticals fees based on a percentage of the net
profits from sales of the product above a specified baseline
within assigned sales territories.
Each of these co-promotion agreements is subject to
sunset fees that require the Company to pay
additional fees for up to one year in the event of certain
defined terminations of the agreements.
Sales and
Marketing Agreement
In September 2005, the Company entered into a sales and
marketing agreement with Pliva, Inc. (Pliva). Under
this agreement, the Company receives all revenues, less usual
and customary discounts and a distribution fee to Pliva
calculated as a percentage of net revenues that Pliva generates
on sales of Propoxyphene-APAP
100-500. The
current term of the agreement expires December 31, 2008.
The Company has given Pliva notice that at the end of the
current term the Company will terminate the agreement.
Settlements
Lupin
Pharmaceuticals, Inc. and Lupin Ltd.
In January 2005, the Company entered into a co-promotion
agreement with Lupin Pharmaceuticals. Under this agreement, the
Company co-promoted
Suprax®,
an oral suspension of cefixime, an anti-infective, with a focus
on primary care physicians. The term of this agreement was
January 1, 2005 through December 31, 2005, unless
terminated earlier.
In May 2005, the Company entered into a collaboration and
license agreement with Lupin Ltd. Under the terms of the
agreement, the Company was to license a cephalexin product for
sale and distribution in the United States and Puerto Rico. The
Company and Lupin Ltd. were to collaborate to direct regulatory
development to seek approval of the product. All development
expenses were to be shared between the parties up to an
aggregate amount of $6.0 million.
Upon obtaining FDA approval, Lupin Ltd. would manufacture and
supply product to the Company at a specified price and would
receive a royalty based on a percentage of revenues generated
from sales. The Company was contractually obligated to maintain
a sales force of at least 200 people at the time of the
launch. In addition, Lupin Ltd. had the right, but not the
obligation, to co-promote the product within the pediatric
market.
The Company was required to make payments in relation to the
product license rights as follows: $1.5 million paid in May
2005; $1.5 million due by May 2006; $1.5 million
within 10 days after submission of an NDA for the product;
$6.0 million within ten days after FDA approval of the
product. In addition, the Company issued Lupin Ltd. a warrant to
purchase 1,746,405 shares of Cornerstone BioPharma
Holdings, Inc. common stock for $0.01 per share. The warrant was
valued at approximately $163,000 and was exercisable anytime
from the grant date for a period of ten years.
In February 2006, Lupin Pharmaceuticals notified the Company
that it had terminated the co-promotion agreement due to the
Companys failure to meet certain requirements under the
agreement.
In May 2006 and July 2006 the Company filed requests for
arbitration related to the collaboration and license agreement
and the co-promotion agreement, respectively.
In December 2006, the Company settled these disputes with Lupin
Ltd. and Lupin Pharmaceuticals. The settlement agreement
required the Company to release all of its interests in Suprax,
return any Lupin Ltd. work product or intellectual property
relating to cephalexin and pay the sum of $1.25 million to
Lupin Ltd. in three installments within 180 days of the
settlement. The Lupin Ltd. warrant was placed in escrow and was
cancelled upon completion of the payments. Upon receipt of each
payment, Lupin Ltd. released a portion of
F-82
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
the total warrants issued. In 2007 and 2006, 1,164,270 and
582,135, respectively, common stock shares of this warrant were
deemed to have been cancelled. The Company has valued the
warrants repurchased under the settlement at $547,000 and
recorded that amount as a reduction of equity. The additional
payment required of $703,000 and legal fees of approximately
$505,000 have been included in costs and expenses in 2006 as
other charges. As of December 31, 2006, $800,000 remained
to be paid. As discussed in Note 2, this amount is included
in accrued expenses on the consolidated balance sheet as accrued
arbitration settlement expenses. The Company paid this amount in
full in 2007.
Adams
Respiratory Therapeutics, Inc.
In October 2004, the Company was included as a defendant in
litigation with a related party, Carolina Pharmaceuticals, Inc.,
by Adams Respiratory Therapeutics, Inc. (Adams) that
alleged trademark infringement, false advertising and unfair
competition claims and sought damages and injunctive relief. The
Company vigorously defended these allegations and filed various
counterclaims. In January 2005, Adams and the Company entered
into an agreement under which in February 2005 the Company
received all of the rights to the ALLERX products held by Adams
and Adams received all of the rights to the Humibid family of
products held by the Company. Additionally, the parties released
each other from all claims and damages in the above mentioned
lawsuit. The agreement required the Company to assume the
financial responsibility for the first $1.0 million of
returned Humibid product that was sold by the Company prior to
February 15, 2005 and returned to Adams during the
18-month
period beginning February 15, 2005. The Company recorded
$1.0 million in accrued expenses in the consolidated
balance sheets as of December 31, 2007 and 2006 for this
Humibid liability.
The Company also had $746,000 in accrued royalty expenses
related to ALLERX sales as of December 31, 2007.
Conversely, Adams was financially responsible for the first
$1.0 million of ALLERX product returns for the same
18-month
period. The Company recorded approximately $355,000 and $331,000
in accounts receivable in the consolidated balance sheets as of
December 31, 2007 and 2006, respectively. After the
18-month
period or the $1.0 million threshold is met, the agreement
provided that the Company would have the responsibility for all
ALLERX product returns whether sold by the Company or Adams and
Adams would bear the same liability for Humibid products. In
connection with this agreement, Adams is obligated to pay the
Company a royalty ranging from 1% to 2% of net Humibid
sales for a period of three years after February 15, 2005
with a minimum annual royalty of $50,000. The Company has
recorded $100,000 and $50,000 in accounts receivable in the
consolidated balance sheets as of December 31, 2007 and
2006, respectively, related to the minimum royalty.
In 2006, a major wholesaler indicated that it was in possession
of a significant amount of Humibid prescription inventory. Adams
filed a complaint alleging that the Company and Carolina
Pharmaceuticals, Inc. did not disclose the outstanding inventory
in accordance with the prior agreement and are therefore
financially responsible for the returns. The Company and
Carolina Pharmaceuticals, Inc. believed they were not liable for
these returns under the agreement and filed a counterclaim.
Since all Humibid prescription products were sold by Carolina
Pharmaceuticals, Inc., the Company did not accrue any amounts
related to this claim.
In May 2008, the Company settled the dispute with Adams. The
agreement provides that all parties to the settlement are to be
released from all legal claims made prior to January 2008 and
that the Company and Carolina Pharmaceuticals, Inc. shall pay to
Reckitt Benckiser, Inc., the parent of Adams, $1.5 million
in three installments to be paid as follows: $500,000 by
June 20, 2008; $500,000 by June 30, 2008; and $500,000
by September 30, 2008. In exchange, the Company is released
from all liabilities. The total net amount accrued on the
Companys consolidated balance sheet as of
December 31, 2007 was approximately $1.3 million. As
of June 30, 2008, the Company has paid $1.0 million
related to the settlement agreement. The Company expects to pay
$291,000 on September 30, 2008. Carolina Pharmaceuticals,
Inc. will make the remaining payment of $209,000.
F-83
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Others
In November 2006, the Company filed a legal complaint against a
pharmaceutical company, certain affiliates of the pharmaceutical
company and the manufacturer of a product launched by the
pharmaceutical company that the Company believed infringed upon
the patent of one of its products. By January 2007, the disputes
with all involved parties were settled. The terms of the
settlements required the parties to admit and acknowledge that
the claims of the patent are valid and enforceable and covenant
that the parties will not infringe on the claims of the patent
by making, using, selling or offering for sale any product that
would infringe on the patent. The settlements provided that the
Company pay the parties for the value of certain inventory on
hand, which was destroyed. The Company accrued approximately
$256,000 in 2006 related to these potential inventory purchases.
These amounts, in addition to the legal fees related to the
settlement of approximately $215,000, are included in the
accompanying consolidated statements of operations as other
charges in 2006. The total actual inventory payments made
related to the settlement in 2007 amounted to approximately
$236,000, and the excess accrual of $20,000 was reversed as of
December 31, 2007.
In addition, as part of the settlement, the Company also
committed to pay $75,000 for trademark rights. The Company also
made this payment in 2007.
In response to a claim of infringement filed by the Company in
early 2008, a pharmaceutical company has filed a counterclaim
that the patent, which is licensed to the Company, is invalid
and moved to stay the litigation pending the re-examination of
the Companys patent. No monetary relief has been requested
in the counterclaim. The court granted defendants motion
and stayed the litigation pending the re-examination of the
Companys patent in February 2008. Separately, the
U.S. Patent and Trademark Office ordered a re-examination
of the patent. Additionally, in June 2008, the pharmaceutical
company requested that the U.S. Patent and Trademark Office
re-examine a related second patent licensed to the Company by an
affiliate of the licensor of the first patent, which is not at
issue in the litigation. In concert with the licensor of the
patents, the Company intends to vigorously pursue its claims and
defend the counterclaim. The Companys intellectual
property counsel has concluded that valid arguments exist for
distinguishing the claims of the Companys patents over the
references cited in the requests for re-examination. If the
United States Patent and Trademark Office invalidates some or
all of the claims under these patents, the Company could be
exposed to increased generic competition relating to its various
day-night products, and its future operating and financial
results could be adversely affected. Because no monetary relief
has been requested in the counterclaim, no amount has been
accrued in these consolidated financial statements.
Product
Agreements
In August 2006, the Company loaned Neos $500,000 under a secured
subordinated promissory note agreement. In December 2006, the
Company entered into a product development agreement with Neos
providing the Company with an exclusive license to certain
products under development utilizing Neoss time release
suspension technology. Under the terms of the agreement, the
note with Neos was forgiven. The Company has recorded the
$500,000 consideration as product rights related to the time
release suspension technology. The agreement requires Neos to
develop each product at its own expense up to a defined
milestone. After that milestone is achieved, the Company is
required to reimburse Neos 110% of all direct costs incurred and
pay $150 per hour for personnel time incurred in the development
of the products. The Company will also make milestone payments
up to $1.0 million for each product based on specific
events. No development costs or milestone payments have been
made or accrued as of December 31, 2007. Upon
commercialization, the Company would also pay Neos royalties
based on a percentage of net sales.
During 2007, the Company entered various research and
development agreements. As of December 31, 2007, the
Company had outstanding commitments related to ongoing research
and development contracts totaling approximately $312,000.
F-84
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Severance
Selected executive employees of the Company have employment
agreements which provide for severance payments ranging from
three to 12 months of salary and benefits upon termination,
depending on the reasons for the termination. The executive
would also be required to execute a release and settlement
agreement. No amount has been accrued for severance as of
December 31, 2007 or 2006.
Foregone
Merger
In June 2006, the Company was approached by a public company
listed on the London Stock Exchange and offered the opportunity
to merge with the public company. The Company pursued this
opportunity until it was informed that the public company had
been purchased, which resulted in the abandonment of the
potential merger. Legal costs incurred in 2006 related to this
opportunity of approximately $240,000 have been included in the
accompanying consolidated statement of operations.
|
|
NOTE 14:
|
SUBSEQUENT
EVENTS
|
Development
Agreements
In February 2008, the Company entered into a development and
manufacturing agreement requiring payment of $250,000 to Neos
and $250,000 to Coating Place, Inc. (Coating Place)
in relation to the development of a new product. The agreement
includes licenses by Neos and Coating Place of their respective
patent-pending technologies that are being used to develop the
new product. After the product is launched, the parties will
share net profits from sales of the product in equal parts.
In March 2008, the Company entered into a development, license
and services agreement with Neos to license certain Neos
patent-pending technology. Under the agreement, Neos will
perform development work on a new product. The Company will pay
hourly fees for the development work in addition to an aggregate
of $1.75 million in monthly fees from January 2008 through
August 2008.
Lease
Agreement
In May 2008, the Company entered into a lease agreement for a
new corporate headquarters, which will occupy approximately
14,900 square feet of office space and is located in the
Crescent Lakeside office complex, in Cary, North Carolina. The
lease has an initial term that commences in December 2008 and
expires in March 2016. Initial annual base rent under the lease
is approximately $350,000 with annual rent increases of
approximately 3%. The Company also has an option to renew the
lease for an additional
five-year
term through March 2021.
Proposed
Merger with Critical Therapeutics
On May 1, 2008, the Company and Critical Therapeutics
entered into a merger agreement pursuant to which Neptune
Acquisition Corp., a wholly owned subsidiary of Critical
Therapeutics, will merge with and into the Company (the
Merger), with the Company continuing after the
merger as the surviving company and a wholly owned subsidiary of
Critical Therapeutics (the Merger Agreement). If the
Merger is completed, at the effective time of the Merger, all
outstanding shares of the Companys common stock will be
converted into and exchanged for shares of Critical
Therapeutics common stock, and all outstanding options,
whether vested or unvested, and all outstanding warrants to
purchase the Companys common stock will be assumed by
Critical Therapeutics and become options and warrants to
purchase Critical Therapeutics common stock. The Merger
Agreement provides that, at the effective time of the Merger,
Critical Therapeutics will issue to the Companys
stockholders, and assume the Companys options and warrants
that will represent, an aggregate of approximately
101.5 million shares of Critical Therapeutics common
stock, subject to adjustment as a result of a contemplated
reverse stock split of Critical Therapeutics common stock
to occur in connection with the
F-85
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Merger. Immediately following the effective time of the Merger,
the Companys stockholders will own approximately 70%, and
Critical Therapeutics stockholders will own approximately
30%, of Critical Therapeutics common stock, assuming the
exchange or conversion prior to the merger of the outstanding
principal amount of the Carolina Note into shares of
Cornerstones common stock and after giving effect to
shares issuable pursuant to the Companys outstanding
options and warrants, but without giving effect to any shares
issuable pursuant to Critical Therapeutics outstanding
options and warrants. The exchange ratio per share of the
Companys common stock will be based on the number of
shares of the Companys common stock outstanding on a fully
diluted basis immediately prior to the effective time of the
Merger and will not be determined until that time.
The consummation of the Merger is subject to a number of closing
conditions, including the approval of both the Companys
stockholders and Critical Therapeutics stockholders,
approval by The NASDAQ Stock Market LLC of Critical
Therapeutics application for re-listing of its common
stock in connection with the Merger, the continued availability
of its products and other customary closing conditions. As a
condition to the Merger, Carolina Pharmaceuticals has entered
into an agreement that provides, among other things, for the
exchange or conversion of the outstanding principal amount of
the Carolina Note into shares of the Companys common stock
prior to the effective time of the merger. The Company is
targeting a closing of the transaction in the fourth quarter of
2008.
Immediately prior to the effective time of the Merger, Critical
Therapeutics has agreed to effect a reverse stock split of its
common stock whereby each issued and outstanding share of its
common stock will be reclassified and combined into a fractional
number of shares of common stock. The reverse stock split ratio
is to be mutually agreed upon by the Company and Critical
Therapeutics. The reverse stock split is necessary so that as of
the effective time of the Merger Critical Therapeutics will
satisfy the minimum bid price requirement pursuant to the
initial listing standards for The NASDAQ Capital Market.
The Merger Agreement provides for the payment of a termination
fee of $1.0 million by each of the Company and Critical
Therapeutics to the other party in specified circumstances in
connection with the termination of the Merger Agreement. In
addition, in specified circumstances in connection with
termination of the Merger Agreement, Critical Therapeutics has
agreed to reimburse the Company for up to $150,000 in expenses
and the Company has agreed to reimburse Critical Therapeutics
for up to $100,000 in expenses.
F-86
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
NOTE 15:
|
QUARTERLY
FINANCIAL DATA (UNAUDITED)
|
Quarterly
Financial Data (Unaudited)
The following table summarizes selected unaudited condensed
quarterly financial information for 2007 and 2006. The Company
believes that all adjustments, consisting of normal recurring
adjustments considered necessary for a fair presentation, have
been included in the selected quarterly information (in
thousands).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
Quarter
|
|
|
|
Ended
|
|
|
Ended
|
|
|
Ended
|
|
|
Ended
|
|
|
|
December 31,
|
|
|
September 30,
|
|
|
June 30,
|
|
|
March 31,
|
|
|
|
(In thousands, except per share data)
|
|
|
|
(Unaudited)
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
5,966
|
|
|
$
|
7,902
|
|
|
$
|
5,515
|
|
|
$
|
8,688
|
|
Total operating expenses
|
|
|
6,853
|
|
|
|
6,770
|
|
|
|
6,168
|
|
|
|
5,839
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income
|
|
|
(887
|
)
|
|
|
1,132
|
|
|
|
(653
|
)
|
|
|
2,849
|
|
Other expenses
|
|
|
(716
|
)
|
|
|
(368
|
)
|
|
|
(317
|
)
|
|
|
(340
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before income taxes
|
|
|
(1,603
|
)
|
|
|
764
|
|
|
|
(970
|
)
|
|
|
2,509
|
|
Income taxes
|
|
|
551
|
|
|
|
(147
|
)
|
|
|
98
|
|
|
|
(632
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(1,052
|
)
|
|
$
|
617
|
|
|
$
|
(872
|
)
|
|
$
|
1,877
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share, basic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share, diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$
|
3,963
|
|
|
$
|
8,571
|
|
|
$
|
3,535
|
|
|
$
|
6,048
|
|
Total operating expenses
|
|
|
7,200
|
|
|
|
5,015
|
|
|
|
4,368
|
|
|
|
4,564
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income
|
|
|
(3,237
|
)
|
|
|
3,556
|
|
|
|
(833
|
)
|
|
|
1,484
|
|
Other expenses
|
|
|
(321
|
)
|
|
|
(291
|
)
|
|
|
(290
|
)
|
|
|
(373
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(3,558
|
)
|
|
$
|
3,265
|
|
|
$
|
(1,123
|
)
|
|
$
|
1,111
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share, basic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share, diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-87
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
|
|
(In thousands, except share and per share data)
|
|
|
Assets
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
19
|
|
|
$
|
241
|
|
Marketable security
|
|
|
8
|
|
|
|
8
|
|
Accounts receivable, net
|
|
|
10,300
|
|
|
|
6,529
|
|
Amounts due from related parties
|
|
|
713
|
|
|
|
648
|
|
Inventories, net
|
|
|
3,659
|
|
|
|
2,998
|
|
Prepaid expenses
|
|
|
509
|
|
|
|
278
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
15,208
|
|
|
|
10,702
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
187
|
|
|
|
209
|
|
|
|
|
|
|
|
|
|
|
Other assets:
|
|
|
|
|
|
|
|
|
Product rights, net
|
|
|
5,838
|
|
|
|
4,936
|
|
Amounts due from related parties
|
|
|
38
|
|
|
|
29
|
|
Deposits
|
|
|
50
|
|
|
|
33
|
|
|
|
|
|
|
|
|
|
|
Total other assets
|
|
|
5,926
|
|
|
|
4,998
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
21,321
|
|
|
$
|
15,909
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
3,276
|
|
|
$
|
2,214
|
|
Accrued expenses
|
|
|
13,944
|
|
|
|
11,163
|
|
Current portion of license agreement liability
|
|
|
576
|
|
|
|
576
|
|
Line of credit
|
|
|
|
|
|
|
1,750
|
|
Income taxes payable
|
|
|
916
|
|
|
|
130
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
18,712
|
|
|
|
15,833
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
License agreement liability, less current portion
|
|
|
2,959
|
|
|
|
2,959
|
|
Note payable, related party
|
|
|
8,952
|
|
|
|
9,412
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities
|
|
|
11,911
|
|
|
|
12,371
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
30,623
|
|
|
|
28,204
|
|
|
|
|
|
|
|
|
|
|
Stockholders deficit
|
|
|
|
|
|
|
|
|
Common stock $0.0001 par value,
50,000,000 shares authorized 24,926,150 shares issued
and outstanding
|
|
|
2
|
|
|
|
2
|
|
Additional paid-in capital
|
|
|
970
|
|
|
|
801
|
|
Accumulated deficit
|
|
|
(10,274
|
)
|
|
|
(13,098
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders deficit
|
|
|
(9,302
|
)
|
|
|
(12,295
|
)
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders deficit
|
|
$
|
21,321
|
|
|
$
|
15,909
|
|
|
|
|
|
|
|
|
|
|
F-88
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
(In thousands, except share and per share data)
|
|
|
Net revenues
|
|
$
|
23,512
|
|
|
$
|
14,203
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of product sales (exclusive of amortization of product
rights of $848 and $1,653 in the six months ended June 30,
2008 and 2007, respectively)
|
|
|
1,498
|
|
|
|
1,516
|
|
Sales and marketing
|
|
|
7,534
|
|
|
|
4,852
|
|
Royalties
|
|
|
4,804
|
|
|
|
1,631
|
|
General and administrative
|
|
|
3,773
|
|
|
|
2,078
|
|
Research and development
|
|
|
605
|
|
|
|
113
|
|
Amortization and depreciation
|
|
|
886
|
|
|
|
1,686
|
|
Other charges
|
|
|
27
|
|
|
|
131
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
19,127
|
|
|
|
12,007
|
|
|
|
|
|
|
|
|
|
|
Income from operations
|
|
|
4,385
|
|
|
|
2,196
|
|
|
|
|
|
|
|
|
|
|
Other expenses:
|
|
|
|
|
|
|
|
|
Interest expense, net
|
|
|
(722
|
)
|
|
|
(657
|
)
|
|
|
|
|
|
|
|
|
|
Total other expenses
|
|
|
(722
|
)
|
|
|
(657
|
)
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
3,663
|
|
|
|
1,539
|
|
Provision for income taxes
|
|
|
839
|
|
|
|
534
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
2,824
|
|
|
$
|
1,005
|
|
|
|
|
|
|
|
|
|
|
Net income per share, basic
|
|
$
|
0.11
|
|
|
$
|
0.04
|
|
|
|
|
|
|
|
|
|
|
Net income per share, diluted
|
|
$
|
0.10
|
|
|
$
|
0.04
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares, basic
|
|
|
24,926,150
|
|
|
|
24,926,150
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares, diluted
|
|
|
28,776,045
|
|
|
|
27,697,832
|
|
|
|
|
|
|
|
|
|
|
F-89
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
(Unaudited)
|
|
|
|
(In thousands)
|
|
|
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
Net income
|
|
|
2,824
|
|
|
|
1,005
|
|
Adjustments to reconcile net income to net cash provided by
operating activities:
|
|
|
|
|
|
|
|
|
Amortization and depreciation
|
|
|
886
|
|
|
|
1,686
|
|
Stock-based compensation
|
|
|
169
|
|
|
|
641
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
(3,771
|
)
|
|
|
(3,000
|
)
|
Amounts due from related parties
|
|
|
(55
|
)
|
|
|
117
|
|
Inventories, net
|
|
|
(661
|
)
|
|
|
(698
|
)
|
Prepaid expenses
|
|
|
(231
|
)
|
|
|
17
|
|
Accounts payable
|
|
|
1,062
|
|
|
|
(253
|
)
|
Accrued expenses
|
|
|
2,781
|
|
|
|
286
|
|
Income taxes payable
|
|
|
786
|
|
|
|
534
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
3,790
|
|
|
|
335
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
Advances to related parties
|
|
|
(19
|
)
|
|
|
(526
|
)
|
Proceeds from collection of advances to related parties
|
|
|
|
|
|
|
203
|
|
Purchase of property and equipment
|
|
|
(16
|
)
|
|
|
|
|
Purchase of product rights
|
|
|
(1,750
|
)
|
|
|
(75
|
)
|
Collection of deposits
|
|
|
15
|
|
|
|
50
|
|
Payment of deposits
|
|
|
(32
|
)
|
|
|
(5
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(1,802
|
)
|
|
|
(353
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
Proceeds from line of credit
|
|
$
|
5,500
|
|
|
$
|
5,500
|
|
Principal payments on line of credit
|
|
|
(7,250
|
)
|
|
|
(5,050
|
)
|
Principal payments on notes payable
|
|
|
(460
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities
|
|
|
(2,210
|
)
|
|
|
450
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(222
|
)
|
|
|
432
|
|
Cash and cash equivalents as of beginning of period
|
|
|
241
|
|
|
|
116
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents as of end of period
|
|
$
|
19
|
|
|
$
|
548
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information
|
|
|
|
|
|
|
|
|
Cash paid during the period for interest
|
|
$
|
52
|
|
|
$
|
85
|
|
|
|
|
|
|
|
|
|
|
F-90
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
(Unaudited)
|
|
NOTE 1:
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
Nature of
Operations
Cornerstone BioPharma Holdings, Inc., together with its
subsidiaries (collectively, the Company), is a
specialty pharmaceutical company focused on acquiring,
developing and commercializing prescription products for the
respiratory market. The Companys commercial strategy is to
acquire non-promoted or underperforming branded pharmaceutical
products and then maximize their potential value by promoting
the products using its sales and marketing capabilities and
applying various product life cycle management techniques.
Business
Risk and Liquidity
The Companys consolidated financial statements have been
prepared on a basis which assumes that the Company will continue
as a going concern and which contemplates the realization of
assets and the satisfaction of liabilities and commitments in
the normal course of business. From inception in 2004 through
2006, the Company incurred operating losses, including net
losses of $305,000 in 2006 and $11.4 million in 2005. The
Companys net income was $2.8 million in the six
months ended June 30, 2008 and $570,000 in the year ended
December 31, 2007. As of June 30, 2008,
Cornerstones accumulated deficit was $10.3 million.
The Company expects to continue to incur significant development
and commercialization expenses as it advances the development of
its product candidates; seeks regulatory approvals for its
product candidates that successfully complete clinical testing;
and expands its sales team and marketing capabilities to prepare
for the commercial launch of future products, subject to
approval by the U.S. Food and Drug Administration
(FDA). The Company also expects to incur additional
expenses to add operational, financial and management
information systems and personnel, including personnel to
support its product development efforts. Accordingly, the
Company will need to increase its revenues to be able to sustain
and increase its profitability on an annual and quarterly basis.
There is no assurance that the Company will be able to do so.
The Companys failure to achieve consistent profitability
could impair its ability to raise capital, expand its business,
diversify its product offerings and continue its operations.
To the extent that the Companys capital resources are
insufficient to meet its future capital requirements, the
Company will need to finance its cash needs through public or
private equity offerings, debt financings, corporate
collaboration and licensing arrangements or other financing
alternatives. The Companys only committed external source
of funds is borrowing availability under its line of credit. The
Companys ability to borrow under the line of credit is
subject to its satisfaction of specified conditions. Additional
equity or debt financing, or corporate collaboration and
licensing arrangements, may not be available on acceptable
terms, if at all.
As of June 30, 2008, the Company had $19,000 of cash and
cash equivalents on hand and borrowing availability of
$3.9 million under its line of credit. Based on its current
operating plans, the Company believes that its existing cash and
cash equivalents, revenues from product sales and borrowing
availability under the line of credit are sufficient to continue
to fund its existing level of operating expenses and capital
expenditure requirements as a standalone company for the
foreseeable future. However, lower than projected cash flows as
a result of reduced net product sales or increased expenses
could require the Company to raise additional capital in order
to sustain its operations. There can be no assurance that
managements plan will be executed as anticipated.
Basis of
Presentation
The accompanying unaudited consolidated financial statements
include the accounts of Cornerstone BioPharma Holdings, Inc. and
its wholly owned subsidiaries and have been prepared in
accordance with
F-91
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
accounting principles generally accepted in the United States of
America (GAAP) for interim financial information and
with Article 10 of
Regulation S-X.
Accordingly, they do not include all of the information and
footnotes required by GAAP for complete financial statements.
The Company believes that all adjustments, consisting of normal
recurring adjustments, considered necessary for a fair
presentation, have been included. The unaudited consolidated
financial statements should be read in conjunction with
Cornerstones Managements Discussion and
Analysis of Financial Condition and Results of Operations
and the Companys consolidated audited financial
statements, including related notes, which are included in this
proxy statement/prospectus.
Operating results for the six-month periods ended June 30,
2008 and 2007 are not necessarily indicative of the results for
the full year.
The preparation of financial statements in conformity with GAAP
requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of
the financial statements, and the reported amounts of revenues
and expenses during the reporting period. Actual results could
differ from those estimates or assumptions. The more significant
estimates reflected in the Companys consolidated financial
statements include certain judgments regarding revenue
recognition, product rights, inventory valuation, accrued
expenses and stock-based compensation.
Revenue
Recognition
The Companys consolidated net revenues include net product
sales and royalty agreement revenues. The following table sets
forth the categories of the Companys net revenues for the
six months ended June 30, 2008 and 2007, respectively (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Gross product sales
|
|
$
|
28,091
|
|
|
$
|
16,755
|
|
Sales allowances
|
|
|
(5,366
|
)
|
|
|
(3,275
|
)
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
|
22,725
|
|
|
|
13,480
|
|
Royalty agreement revenues
|
|
|
787
|
|
|
|
723
|
|
Net revenues
|
|
$
|
23,512
|
|
|
$
|
14,203
|
|
|
|
|
|
|
|
|
|
|
Product
Sales
The Company recognizes revenue from its product sales in
accordance with Securities and Exchange Commission Staff
Accounting Bulletin (SAB) No. 104, Revenue
Recognition, and SFAS No. 48, Revenue
Recognition When Right of Return Exists
(SFAS 48), upon transfer of title, which
occurs when product is received by its customers. The Company
sells its products primarily to pharmaceutical wholesalers,
distributors and pharmacies, which have the right to return the
products they purchase. Under SFAS 48, the Company is
required to reasonably estimate the amount of future returns at
the time of revenue recognition. The Company recognizes product
sales net of estimated allowances for product returns; estimated
rebates in connection with contracts relating to managed care,
Medicaid and Medicare; estimated chargebacks; price adjustments;
product vouchers; co-pay vouchers; and prompt payment and other
discounts.
The Company establishes revenue reserves on a
product-by-product
basis as its best estimate at the time of sale based on
historical experience for each product adjusted to reflect known
changes in the factors that impact such reserves. Reserves for
chargebacks, rebates, vouchers and related allowances are
established based upon contractual terms with customers;
analysis of historical levels of discounts, chargebacks, rebates
and
F-92
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
voucher redemptions; communications with customers; purchased
information about the rate of prescriptions being written and
the levels of inventory remaining in the distribution channel;
expectations about the market for each product; and anticipated
introduction of competitive products.
Consistent with industry practice, the Company offers customers
the ability to return products in the six months prior to, and
the 12 months after, the products expire. The Company
adjusts its estimate of product returns if it becomes aware of
other factors that it believes could significantly impact its
expected returns. These factors include its estimate of
inventory levels of its products in the distribution channel,
the shelf life of the product shipped, competitive issues such
as new product entrants and other known changes in sales trends.
The Company evaluates this reserve on a quarterly basis,
assessing each of the factors described above, and adjusts the
reserve accordingly.
The Companys estimates of product rebates and price
adjustments are based on its estimated mix of sales to various
third-party payors, which are entitled either contractually or
statutorily to discounts from the Companys listed prices
of its products. The Company makes these judgments based upon
the facts and circumstances known to it in accordance with GAAP.
In the event that the sales mix to third-party payors is
different from its estimates, the Company may be required to pay
higher or lower total rebates than it has estimated.
Royalty
Agreement Revenues
The Company also receives royalties under license agreements
with a number of third parties that sell products to which the
Company has rights. The license agreements provide for the
payment of royalties based on sales of the licensed product.
These revenues are recorded based on estimates of the sales that
occurred in the relevant period. The relevant period estimates
of sales are based on interim data provided by the licensees and
analysis of historical royalties paid, adjusted for any changes
in facts and circumstances, as appropriate. The Company
maintains regular communication with its licensees to gauge the
reasonableness of its estimates. Differences between actual
royalty agreement revenues and estimated royalty agreement
revenues are reconciled and adjusted for in the period in which
they become known, typically the following quarter.
New
Accounting Pronouncements
In May 2008, the FASB issued SFAS No. 162, The
Hierarchy of Generally Accepted Accounting Principles
(SFAS 162). SFAS 162 identifies the
sources of accounting principles and the framework for selecting
the principles to be used in the preparation of financial
statements of nongovernmental entities that are presented in
conformity with GAAP (the GAAP hierarchy).
SFAS 162 makes the GAAP hierarchy explicitly and directly
applicable to preparers of financial statements, a step that
recognizes preparers responsibilities for selecting the
accounting principles for their financial statements, and sets
the stage for making the framework of FASB Concept Statements
fully authoritative. The effective date for SFAS 162 is
60 days following the SECs approval of the Public
Company Accounting Oversight Boards related amendments to
remove the GAAP hierarchy from auditing standards, where it has
resided for some time. The Company does not expect the adoption
of SFAS 162 to have a material impact on its financial
statements.
In April 2008, the FASB issued FASB Staff Position Financial
Accounting Standard
142-3,
Determination of the Useful Life of Intangible Assets
(FSP
FAS 142-3).
FSP
FAS 142-3
amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful
life of a recognized intangible asset under SFAS 142,
Goodwill and Other Intangible Assets. In developing
assumptions about renewal or extension, FSP
FAS 142-3
requires an entity to consider its own historical experience or,
if it has no experience, market participant assumptions,
adjusted for the entity-specific factors in paragraph 11 of
SFAS 142. FSP
FAS 142-3
expands the disclosure requirements of SFAS 142 and is
effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods
within those fiscal
F-93
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
years, with early adoption prohibited. The guidance for
determining the useful life of a recognized intangible asset
must be applied prospectively to intangible assets acquired
after the effective date. The disclosure requirements must be
applied prospectively to all intangible assets recognized as of,
and subsequent to, the effective date. The Company does not
expect the adoption of FSP
FAS 142-3
to have a material impact on its financial statements.
In November 2007, the FASBs Emerging Issues Task Force
(EITF) issued EITF Issue
No. 07-01,
Accounting for Collaborative Arrangements
(EITF 07-01).
EITF 07-01
requires collaborators to present the results of activities for
which they act as the principal on a gross basis and report any
payments received from or made to other collaborators based on
other applicable generally accepted accounting principles or, in
the absence of other applicable generally accepted accounting
principles, based on analogy to authoritative accounting
literature or a reasonable, rational and consistently applied
accounting policy election.
EITF 07-01
is effective for fiscal years beginning after December 15,
2008. The Company does not expect the adoption of
EITF 07-01
to have a material impact on its financial statements.
In June 2007, the EITF issued EITF Issue
No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development
Activities
(EITF 07-3).
EITF 07-03
concludes that non-refundable advance payments for future
research and development activities should be deferred and
capitalized until the goods have been delivered or the related
services have been performed. If an entity does not expect the
goods to be delivered or services to be rendered, the
capitalized advance payments should be charged to expense.
EITF 07-3
is effective for fiscal years beginning after December 15,
2007. The initial adjustment to reflect the effect of applying
this EITF as a change in accounting principle is accounted for
as a cumulative-effect adjustment to retained earnings as of the
beginning of the year of adoption. The adoption of
EITF 07-03
did not have a material impact on the Companys financial
statements.
In December 2007, the FASB issued SFAS No. 141(R),
Business Combinations (SFAS 141(R)).
SFAS 141(R) requires the acquiring entity in a business
combination to record all assets acquired and liabilities
assumed at their respective acquisition-date fair values and
changes other practices under SFAS No. 141,
Business Combinations, some of which could have a
material impact on how an entity accounts for its business
combinations. SFAS 141(R) also requires additional
disclosure of information surrounding a business combination so
that users of the entitys financial statements can fully
understand the nature and financial impact of the business
combination. SFAS 141(R) is effective for fiscal years
beginning after December 15, 2008 and is applied
prospectively to business combinations for which the acquisition
date is on or after January 1, 2009. The provisions of
SFAS 141(R) will only impact the Companys financial
statements if the Company is a party to a business combination
after the effective date of the pronouncement.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interest in Consolidated Financial
Statements an amendment of ARB No. 51
(SFAS 160). SFAS 160 requires entities
to report non-controlling minority interests in subsidiaries as
equity in consolidated financial statements. SFAS 160 is
effective for fiscal years beginning on or after
December 15, 2008. SFAS 160 is applied prospectively
as of the beginning of the fiscal year in which it is initially
applied, except for presentation and disclosure requirements,
which are applied retrospectively for all periods presented. The
Company does not expect the adoption of SFAS 160 to have a
material impact on its financial statements.
In February 2007, the FASB issued SFAS No. 159, The
Fair Value Option for Financial Assets and Financial
Liabilities, Including an Amendment of SFAS 115
(SFAS 159). SFAS 159 permits companies to
choose to measure many financial instruments and certain other
items at fair value. It also establishes presentation and
disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes
for similar types of assets and liabilities. SFAS 159
requires companies to provide additional information that will
help investors and other users of financial statements to more
easily understand the effect of a companys choice to use
fair value on its earnings. It also requires companies to
F-94
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
display the fair value of those assets and liabilities for which
they have chosen to use fair value on the face of the balance
sheet. SFAS 159 is effective for fiscal years beginning
after November 15, 2007 and interim periods within those
fiscal years. The Company was required to adopt SFAS 159 on
January 1, 2008. The adoption of SFAS 159 did not have
a material impact on the Companys financial statements.
In September 2006, the FASB issued SFAS No. 157,
Fair Value Measurements (SFAS 157).
SFAS 157 defines fair value, establishes a framework for
measuring fair value in GAAP and expands disclosures about fair
value measurements. In February 2008, the FASB issued
FSP 157-2,
which defers the effective date of applying the provisions of
SFAS 157 to the fair value measurement of nonfinancial
assets and nonfinancial liabilities until fiscal years beginning
after November 15, 2008. The Company adopted the provisions
of SFAS 157 that pertain to financial assets and
liabilities on January 1, 2008. The adoption of
SFAS 157 did not have a material impact on the
Companys financial statements. The Company is currently
evaluating the effect
FSP 157-2
will have on its financial statements.
In July 2006, the FASB issued Interpretation No. 48,
Accounting for Uncertainty in Income Taxes an
interpretation of FASB Statement No. 109
(FIN 48). FIN 48 clarifies the
accounting for uncertainty in income taxes recognized in an
enterprises financial statements in accordance with
SFAS No. 109 and prescribes a recognition threshold
and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected
to be taken in a tax return. FIN 48 also provides guidance
on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition.
FIN 48 is effective for fiscal years beginning after
December 15, 2006. The adoption of FIN 48 did not have
a material impact on the Companys financial statements.
Inventories
Inventories are stated at the lower of cost or market value with
cost determined under the
first-in,
first-out method. The Company held $3.7 million and
$3.0 million of inventory as of June 30, 2008 and
December 31, 2007, respectively. On a quarterly basis, the
Company analyzes its inventory levels and writes down inventory
that has become obsolete, inventory that has a cost basis in
excess of the expected net realizable value and inventory that
is in excess of expected requirements based upon anticipated
product revenues. As of June 30, 2008 and December 31,
2007, the Company established an allowance for obsolete
inventory of $97,000 and $201,000, respectively.
Inventories consisted of the following as of June 30, 2008
and December 31, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Raw materials
|
|
$
|
1,504
|
|
|
$
|
1,564
|
|
Work in process
|
|
|
|
|
|
|
287
|
|
Finished goods:
|
|
|
|
|
|
|
|
|
Pharmaceutical products trade
|
|
|
1,489
|
|
|
|
625
|
|
Pharmaceutical products samples
|
|
|
763
|
|
|
|
723
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
3,756
|
|
|
|
3,199
|
|
|
|
|
|
|
|
|
|
|
Inventory allowances
|
|
|
(97
|
)
|
|
|
(201
|
)
|
|
|
|
|
|
|
|
|
|
Inventories, net
|
|
$
|
3,659
|
|
|
$
|
2,998
|
|
|
|
|
|
|
|
|
|
|
F-95
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Property
and Equipment
Property and equipment consisted of the following as of
June 30, 2008 and December 31, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Computers and software
|
|
$
|
250
|
|
|
$
|
244
|
|
Machinery and equipment
|
|
|
6
|
|
|
|
6
|
|
Furniture and fixtures
|
|
|
124
|
|
|
|
114
|
|
Leasehold improvements
|
|
|
15
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
395
|
|
|
|
379
|
|
Less accumulated depreciation
|
|
|
(208
|
)
|
|
|
(170
|
)
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$
|
187
|
|
|
$
|
209
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense for the six months ended June 30, 2008
and 2007 was $38,000 and $32,000, respectively.
Product
Rights
Product rights consisted of the following as of June 30,
2008 and December 31, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
BALACET®
product rights acquired from Vintage Pharmaceuticals, LLC
(Vintage)
|
|
$
|
7,549
|
|
|
$
|
7,549
|
|
SPECTRACEF®
product rights acquired through entry into a license agreement
with Meiji Seika Kaisha, Ltd. (Meiji)
|
|
|
4,505
|
|
|
|
4,505
|
|
Technology rights acquired from Neos Therapeutics, L.P.
(Neos)
|
|
|
500
|
|
|
|
500
|
|
Product rights acquired from Coating Place, Inc. (Coating
Place) and Neos
|
|
|
1,750
|
|
|
|
|
|
ALLERX®
trademark acquired from Everton Pharmaceuticals, LLC
(Everton)
|
|
|
75
|
|
|
|
75
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
14,379
|
|
|
|
12,629
|
|
Less accumulated amortization
|
|
|
(8,541
|
)
|
|
|
(7,693
|
)
|
|
|
|
|
|
|
|
|
|
Product rights, net
|
|
$
|
5,838
|
|
|
$
|
4,936
|
|
|
|
|
|
|
|
|
|
|
Amortization expense for the six months ended June 30, 2008
and 2007 was $848,000 and $1.7 million, respectively. The
Company is amortizing the BALACET product rights over an
estimated useful life of three years, the SPECTRACEF product
rights over an estimated useful life of nine years and the
ALLERX trademark over an estimated useful life of four years.
The Company expects to begin amortizing the rights acquired from
Neos and Coating Place upon commercialization of the first
product using these rights, expected to be in 2009, over an
estimated useful life of 15 years.
F-96
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Future estimated amortization expense (excluding the rights
acquired from Neos and Coating Place) subsequent to
June 30, 2008 is as follows (in thousands):
|
|
|
|
|
2008
|
|
$
|
219
|
|
2009
|
|
|
438
|
|
2010
|
|
|
437
|
|
2011
|
|
|
426
|
|
2012
|
|
|
420
|
|
Thereafter
|
|
|
1,648
|
|
|
|
|
|
|
|
|
$
|
3,588
|
|
|
|
|
|
|
Accrued
Expenses
Accrued expenses consisted of the following as of June 30,
2008 and December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Accrued returns
|
|
$
|
4,153
|
|
|
$
|
4,913
|
|
Accrued rebates
|
|
|
1,189
|
|
|
|
303
|
|
Accrued other sales allowances
|
|
|
570
|
|
|
|
828
|
|
Accrued compensation and benefits
|
|
|
1,232
|
|
|
|
1,596
|
|
Accrued royalties
|
|
|
4,256
|
|
|
|
1,940
|
|
Accrued interest, affiliate
|
|
|
1,951
|
|
|
|
1,490
|
|
Accrued interest
|
|
|
281
|
|
|
|
71
|
|
Accrued expenses, other
|
|
|
312
|
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
Total accrued expenses
|
|
$
|
13,944
|
|
|
$
|
11,163
|
|
|
|
|
|
|
|
|
|
|
The Company has financing under a bank line of credit for up to
$4.0 million, subject to a monthly borrowing base equal to
75% of accounts receivable balances outstanding 90 days or
less and, until June 2008, 50% of inventories. Interest is due
monthly with all outstanding principal and interest due on
maturity. Amounts outstanding under the line of credit bear
interest at a variable rate equal to the Wall Street Journal
prime rate, which was 5.00% as of June 30, 2008.
In June 2008, the Company amended the line of credit. The
amendment extended the line of credits maturity date to
June 2009, required the Companys President and Chief
Executive Officer to maintain a majority ownership in the
Company and added Cornerstone BioPharma, Inc. and Aristos
Pharmaceuticals, Inc. as joint guarantors of the line of credit.
The amendment also revised the collateral for the line of credit
to include assets held by Cornerstone BioPharma, Inc. and
Aristos Pharmaceuticals, Inc. and reduced the $1.0 million
assignment of deposits from the Companys President and
Chief Executive Officer to a $500,000 assignment of deposits.
Finally, the amendment revised the monthly borrowing base by
eliminating the inventory component of the borrowing base and
including in the borrowing base accounts receivable held by
Cornerstone BioPharma, Inc. and Aristos Pharmaceuticals, Inc.
and the $500,000 cash deposited by the Companys President
and Chief Executive Officer.
As of June 30, 2008, there was no outstanding balance on
and $3.9 million of borrowing availability under the line
of credit.
F-97
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Carolina
Note
In April 2004, the Company executed a promissory note with
Carolina Pharmaceuticals Ltd. (Carolina
Pharmaceuticals), an entity under common control with the
Company, to borrow up to $15.0 million for five years with
an annual interest rate of 10% (Carolina Note). The
Company borrowed $13.0 million under the Carolina Note in
April 2004. In June 2006, the Company and Carolina
Pharmaceuticals agreed to offset $3.6 million in principal
and $1.8 million in accrued interest outstanding under the
Carolina Note against equal amounts due to the Company from a
related party.
As of June 30, 2008, $9.0 million of principal and
$2.0 million of accrued interest was outstanding under the
Carolina Note. As of December 31, 2007, $9.4 million
in principal and $1.5 million of accrued interest was
outstanding under the Carolina Note. The outstanding principal
and accrued interest are due in 2009. As of June 30, 2008,
the fair value of the Carolina Note was approximately
$8.2 million.
|
|
NOTE 5:
|
STOCKHOLDERS
DEFICIT AND COMPREHENSIVE INCOME
|
As of June 30, 2008 and December 31, 2007 Cornerstone
BioPharma Holdings, Inc. was authorized to issue
50,000,000 shares of common stock par value $0.0001. As of
June 30, 2008, the Company had outstanding
24,926,150 shares of $0.0001 par value common stock.
Restricted
Common Stock
The Company required certain employees to enter into employment
agreements and stock purchase agreements, as subsequently
amended, that would allow them to vest in their stock over time.
The stock vests 25% annually. The Company has the right to
purchase the unvested portion of the restricted common stock on
termination of employment for the original purchase price per
share, which in managements opinion approximated fair
value on the date of issuance. No restricted stock vested during
the six months ended June 30, 2008.
The changes in the Companys components of
stockholders deficit and comprehensive income during the
six months ended June 30, 2008 were as follows (in
thousands, except share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Total
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Paid-in
|
|
|
Accumulated
|
|
|
Stockholders
|
|
|
Comprehensive
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Deficit
|
|
|
Income
|
|
|
Balance as of December 31, 2007
|
|
|
24,926,150
|
|
|
$
|
2
|
|
|
$
|
801
|
|
|
$
|
(13,098
|
)
|
|
$
|
(12,295
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
169
|
|
|
|
|
|
|
|
169
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,824
|
|
|
|
2,824
|
|
|
$
|
2,824
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
2,824
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of June 30, 2008
|
|
|
24,926,150
|
|
|
$
|
2
|
|
|
$
|
970
|
|
|
$
|
(10,274
|
)
|
|
$
|
(9,302
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All stock-based awards are accounted for at their fair market
value in accordance with SFAS No. 123 (revised 2004),
Share-Based Payment (SFAS 123(R)) and
EITF Issue
No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services.
F-98
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
The following table summarizes the stock option activity for the
period of January 1, 2008 through June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
Available
|
|
Granted
|
|
Average
|
|
|
Option
|
|
Options
|
|
Exercise
|
|
|
Shares
|
|
Outstanding
|
|
Price
|
|
Balance as of January 1, 2008
|
|
|
2,896,512
|
|
|
|
7,604,838
|
|
|
$
|
0.31
|
|
Cancelled
|
|
|
15,967
|
|
|
|
(15,967
|
)
|
|
|
0.12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of June 30, 2008
|
|
|
2,912,479
|
|
|
|
7,588,871
|
|
|
$
|
0.31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no options granted or exercised in the six months
ended June 30, 2008.
The Company granted 4,475,000 stock options on March 16,
2007 and 66,500 stock options on May 24, 2007. The exercise
prices of these stock options and the fair value of the
Companys stock on both grant dates were $0.42 per share.
Therefore, the intrinsic value of the stock options on the grant
dates was $0.
As of June 30, 2008, the aggregate intrinsic value of
options outstanding was $1,777,113 and the aggregate intrinsic
value of options exercisable was $1,066,700.
The following table summarizes the stock options vested and
expected to vest as of June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average
|
|
|
|
|
|
|
Remaining
|
|
|
|
|
|
|
Contractual Life
|
|
Weighted-Average
|
|
|
Number of Options
|
|
(In Years)
|
|
Exercise Price
|
|
Outstanding
|
|
|
7,588,871
|
|
|
|
8.29
|
|
|
$
|
0.31
|
|
Exercisable
|
|
|
3,296,312
|
|
|
|
7.93
|
|
|
$
|
0.22
|
|
The following table summarizes information about the
Companys stock options as of June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average
|
|
|
|
|
|
|
Contractual Life
|
|
|
Exercise Price
|
|
Options Outstanding
|
|
(Years)
|
|
Options Exercisable
|
|
$0.10
|
|
|
2,662,371
|
|
|
|
7.56
|
|
|
|
2,024,937
|
|
0.25
|
|
|
165,000
|
|
|
|
7.00
|
|
|
|
136,250
|
|
0.42
|
|
|
4,535,500
|
|
|
|
8.71
|
|
|
|
1,135,125
|
|
$0.48
|
|
|
226,000
|
|
|
|
9.30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,588,871
|
|
|
|
|
|
|
|
3,296,312
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2008, there was $910,000 of total
unrecognized compensation cost related to nonvested stock-based
compensation arrangements, which is expected to be recognized
over a weighted-average period of 2.59 years.
During the six months ended June 30, 2008, the Company
recorded $164,000 in employee stock-based compensation expense
and $5,000 in non-employee stock-based compensation expense.
During the six months ended June 30, 2007, the Company
recorded $130,000 in employee stock-based compensation expense
and $3,000 in non-employee stock-based compensation expense.
F-99
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Determining the appropriate fair value model and the related
assumptions requires judgment. The fair value of each option
grant is estimated using the Black-Scholes-Merton option-pricing
model on the date of grant as follows:
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
June 30, 2007
|
|
Estimated dividend yield
|
|
|
0.00
|
%
|
Expected stock price volatility
|
|
|
68.00
|
%
|
Risk-free interest rate
|
|
|
4.79
|
|
Expected life of option (in years)
|
|
|
6.04
|
|
Weighted-average fair value per share
|
|
$
|
0.27
|
|
The computation of expected stock price volatility was based on
the historical volatility of a representative peer group of
three comparable companies selected based on publicly available
industry and market capitalization data. These companies were
Aspreva Pharamceuticals, Inc., Critical Therapeutics, Inc.
(Critical Therapeutics) and Oscient Pharmaceuticals
Corporation. The expected life represents the average time that
options that vest are expected to be outstanding. The expected
life of employee stock options is based on the mid-point between
the vesting date and the contractual term in accordance with the
simplified method prescribed in SAB No. 107,
Share-Based Payment, and the expected life for
stock-based compensation granted to non-employees is the
contractual life. The risk-free rate is based on the U.S.
Treasury yield curve during the expected life of the option.
The Companys Board of Directors determines the fair value
at the time of issuance or grant of the Companys equity
instruments to employees and non-employees based upon the
consideration of factors that it deems to be relevant at the
time, including the Companys results of operations; its
available cash, assets and financial condition; its prospects
for growth; and positive or negative business developments since
the Board of Directors last determination of fair value.
|
|
NOTE 7:
|
NET
INCOME PER SHARE
|
The Company computes net income per share in accordance with
SFAS No. 128, Earnings Per Share
(SFAS 128). Under the provisions of
SFAS 128, basic net income per share is computed by
dividing net income by the weighted-average number of common
shares outstanding. Diluted net income per share is computed by
dividing net income by the weighted-average number of common
shares and dilutive common share equivalents then outstanding.
Common share equivalents consist of the incremental common
shares issuable upon the exercise of stock options and the
impact of vested restricted stock grants.
The following table reconciles the numerator and denominator
used to calculate diluted net income per share (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
2,824
|
|
|
$
|
1,005
|
|
Denominator:
|
|
|
|
|
|
|
|
|
Weighted-average common shares, basic
|
|
|
24,926,150
|
|
|
|
24,926,150
|
|
Dilutive effect of stock options and warrants
|
|
|
3,849,895
|
|
|
|
2,771,682
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares, diluted
|
|
|
28,776,045
|
|
|
|
27,697,832
|
|
|
|
|
|
|
|
|
|
|
F-100
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Operating
Leases
The Company leases its facilities and certain equipment and
automobiles under noncancelable operating leases expiring at
various dates through 2016. Rent expense was $249,000 and
235,000 during the six months ended June 30, 2008 and 2007,
respectively.
Future minimum payments under non-cancelable operating leases
with initial terms of one year or more consist of the following
as of March 31, 2008 (in thousands):
|
|
|
|
|
2008
|
|
$
|
121
|
|
2009
|
|
|
339
|
|
2010
|
|
|
325
|
|
2011
|
|
|
303
|
|
2012
|
|
|
310
|
|
2013 and thereafter
|
|
|
1,239
|
|
|
|
|
|
|
Total minimum lease payments
|
|
$
|
2,637
|
|
|
|
|
|
|
Deferred income tax assets and liabilities are computed annually
for differences between the financial statement and tax bases of
assets and liabilities that will result in taxable or deductible
amounts in the future based on enacted tax laws and rates
applicable to the periods in which the differences are expected
to affect taxable income. Valuation allowances are established
when necessary to reduce deferred tax assets to the amounts
expected to be realized. Income tax expense is the tax payable
or refundable for the period plus or minus the change during the
period in deferred tax assets and liabilities.
The Companys consolidated financial statements include the
accounts of Cornerstone BioPharma Holdings, Inc., Cornerstone
BioPharma, Inc., Cornerstone Biopharma, Ltd., and Aristos
Pharmaceuticals, Inc. Cornerstone Biopharma, Ltd. is an Anguilla
international business company and was taxed as a foreign
corporation for U.S. tax purposes in 2007 and 2006. Because
Cornerstone Biopharma, Ltd. is not subject to income tax in
Anguilla, the Companys consolidated financial statements
do not include a provision for income taxes for this entity.
Cornerstone Biopharma, Ltd.s income would have been taxed
to the owner of Cornerstone BioPharma Holdings, Inc. if
Cornerstone Biopharma, Ltd. had issued dividends to Cornerstone
BioPharma Holdings, Inc. or if Cornerstone BioPharma Holdings,
Inc. had sold the stock of this subsidiary.
F-101
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
The provision for income taxes includes the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Current:
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
688
|
|
|
$
|
403
|
|
State
|
|
|
151
|
|
|
|
131
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
839
|
|
|
|
534
|
|
|
|
|
|
|
|
|
|
|
Deferred:
|
|
|
|
|
|
|
|
|
Federal
|
|
|
|
|
|
|
|
|
State
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total tax provision
|
|
$
|
839
|
|
|
$
|
534
|
|
|
|
|
|
|
|
|
|
|
Deferred income taxes reflect the net tax effects of temporary
differences between the carrying amounts of assets and
liabilities for financial reporting purposes and the amounts
used for income tax purposes. Significant components of the
Companys deferred tax assets as of June 30, 2008 and
December 31, 2007 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Current:
|
|
|
|
|
|
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
$
|
|
|
|
$
|
31
|
|
Inventories, net
|
|
|
195
|
|
|
|
177
|
|
Accrued expenses
|
|
|
2,802
|
|
|
|
2,881
|
|
Valuation allowance
|
|
|
(2,997
|
)
|
|
|
(3,089
|
)
|
|
|
|
|
|
|
|
|
|
Total current deferred tax assets
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
F-102
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Noncurrent:
|
|
|
|
|
|
|
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Tax loss carryforwards
|
|
$
|
9
|
|
|
$
|
656
|
|
Deferred compensation
|
|
|
206
|
|
|
|
203
|
|
Product license rights, net
|
|
|
233
|
|
|
|
244
|
|
Organizational costs, net
|
|
|
1
|
|
|
|
2
|
|
Tax credits
|
|
|
|
|
|
|
62
|
|
Valuation allowance
|
|
|
(425
|
)
|
|
|
(1,143
|
)
|
|
|
|
|
|
|
|
|
|
Total noncurrent deferred tax assets
|
|
|
24
|
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
24
|
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax asset noncurrent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net deferred tax asset
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes computed at the statutory federal income tax rate
of 34% are reconciled to the provision for income taxes as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
United States federal tax at statutory rate
|
|
$
|
1,245
|
|
|
$
|
524
|
|
State taxes (net of federal benefit)
|
|
|
160
|
|
|
|
65
|
|
Nondeductible expenses
|
|
|
134
|
|
|
|
143
|
|
Other
|
|
|
109
|
|
|
|
82
|
|
Increase in valuation allowance
|
|
|
(809
|
)
|
|
|
(280
|
)
|
|
|
|
|
|
|
|
|
|
Provision for income taxes
|
|
$
|
839
|
|
|
$
|
534
|
|
|
|
|
|
|
|
|
|
|
The Company has established a valuation allowance against its
deferred tax assets due to the uncertainty surrounding the
realization of such assets. The valuation allowance decreased by
$809,000 for the period ended June 30, 2008.
As of June 30, 2008, the Company has state tax net
operating loss carryforwards of $268,000 that expire beginning
in the year 2020.
The Tax Reform Act of 1986 contains provisions that limit the
Companys ability to utilize the net operating loss
carryforwards in the case of certain events, including
significant changes in ownership interests. If the
Companys net operating loss carryforwards are limited and
the Company has taxable income that exceeds the permissible
yearly net operating loss carryforwards, the Company would incur
a federal income tax liability even though net operating loss
carryforwards would be available in future years.
F-103
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
|
|
NOTE 10:
|
RELATED
PARTY TRANSACTIONS
|
Stockholders
During the six months ended June 30, 2008 and 2007, the
Company made advances to its President and Chief Executive
Officer, who is also the Companys majority stockholder, of
$10,000 and $314,000, respectively. As of June 30, 2008 and
December 31, 2007, unpaid advances were $658,000 and
$648,000, respectively, and are included in amounts due from
related parties as of those dates.
The Company has certain agreements with its President and Chief
Executive Officer that provide certain benefits related to a
qualified termination or change of control, as defined by the
agreements.
Other
Related Parties
As of June 30, 2008, the Company owes Carolina
Pharmaceuticals $260,000 in accrued royalties related to the
sale of
Humibid®
and
DECONSAL®.
This amount is included in accrued royalties as disclosed in
Note 2. The Company paid $750,000 to Carolina
Pharmaceuticals for royalties in 2006. The Company did not pay
any royalties to Carolina Pharmaceuticals in 2005 or 2007. The
Companys President and Chief Executive Officer is the
Chief Executive Officer and Chairman of the Board of Carolina
Pharmaceuticals and certain other executive officers of the
Company are directors of Carolina Pharmaceutical.
In May 2005, the Company licensed certain product rights to
Auriga Laboratories, Inc. (Auriga), which is also
owned in part
and/or
directed by some of the Companys stockholders. The
effective date of the agreement is August 1, 2005. The
Company received a royalty ranging from 8% to 30% of net sales,
depending on the level of net sales. The Companys royalty
is not to exceed $1.7 million on an annual basis. Auriga
assumed responsibility for royalty payments to the previous
owner of the product rights as of the effective date. In 2006,
the royalty agreement with Auriga was amended to reduce the
royalty rates from 30% to 5% of net sales in a specific calendar
quarter. The amendment also provided for Auriga to issue the
Company 200,000 shares of its common stock. The fair value
of the stock, determined as the trading price on date of grant
discounted 15% for lack of marketability due to a one-year lock
up period, was approximately $332,000. The Company included this
amount in royalty agreement revenues.
The Company recognized royalty agreement revenues under the
agreements with Auriga of $113,000 and $114,000 for the six
months ended June 30, 2008 and 2007, respectively.
|
|
NOTE 11:
|
CONTRACTUAL
AGREEMENTS AND OBLIGATIONS
|
Royalties
The Company has contractual obligations to pay royalties to the
former owners of certain product rights that have been acquired
by or licensed to the Company. These royalties are based on a
percentage of net sales of the particular licensed product.
In August 2006, the Company entered into an agreement with
Pharmaceutical Innovations, LLC (Pharmaceutical
Innovations) for an exclusive license to a
U.S. patent and know-how to manufacture, package, market
and distribute various day-night products. In exchange for these
rights, the Company was required to pay Pharmaceutical
Innovations a special royalty of 8.5% of initial net sales of
day-night products up to a total of $250,000. The Company paid
this special royalty in 2006 and 2007. In addition, the Company
is obligated to pay royalties based on a percentage of the
products annual net sales. The royalty rate increases as
the annual net sales increase. Minimum annual royalties are
$300,000 per year under this agreement during the life of the
licensed patent based on the products currently marketed by the
Company.
F-104
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Inventory
Purchases
The Company purchases inventory from pharmaceutical
manufacturers. During the six months ended June 30, 2008
and 2007, two vendors accounted for 17% and 27% of Company
purchases, respectively.
The Company has entered into an agreement with Vintage to
exclusively manufacture two prescription pain products acquired
from Vintage for prices established by the agreement, subject to
renegotiation at each anniversary date. The agreement expires in
July 2009 and may be renewed for subsequent one-year terms.
In connection with the Companys license agreement with
Meiji, the Company also entered into a supply agreement with
Meiji to purchase minimum quantities of cefditoren pivoxil, the
API in SPECTRACEF, exclusively from Meiji. Under this agreement,
Cornerstone is required to purchase the minimum quantities of
cefditoren pivoxil necessary to support targeted gross sales of
SPECTRACEF after the SPECTRACEF product launch of
$8.0 million for year one, $11.0 million for year two,
$13.0 million for year three, $17.0 million for year
four and $24.0 million for year five. The Company and Meiji
entered into a verbal agreement to expand the scope of the
license and supply agreement in August 2008, and the
parties are currently negotiating a written addendum to the
license and supply agreement, which is expected to supercede the
verbal agreement in September 2008. The current draft of
the written addendum replaces the minimum purchase requirement
for API with a minimum purchase requirement for API, SPECTRACEF
200 mg, SPECTRACEF 400 mg and sample packs of SPECTRACEF
400 mg. Under the current draft of the written addendum,
the Companys aggregate annual combined purchases of API,
SPECTRACEF 200 mg, SPECTRACEF 400 mg and sample packs of
SPECTRACEF 400 mg must exceed $15.0 million during the
first year after either SPECTRACEF 200 mg or SPECTRACEF 400
mg manufactured by Meiji is commercially launched,
$20.0 million during the second year, $25.0 million
during the third year, $30.0 million during the fourth year
and $35.0 million during the fifth year. If the Company
does not meet its minimum purchase requirement in a given year,
the Company must pay Meiji an amount equal to 50% of the
shortfall in that year. The Company expects to exceed the
minimum purchase requirements.
In July 2007, the Company entered into a supply agreement with
Bayer HealthCare, LLC (Bayer) to purchase minimum
quantities of the bulk tablets for the ALLERX Dose Pack family
of products from Bayer during calendar years 2008 and 2009. An
additional one-time cost of up to $135,000 will be due on
December 31, 2009 if the Company fails to meet the minimum
annual purchase requirement of 27.0 million tablets per
year for 2008 and 2009. The Company expects to exceed the
minimum purchase requirements.
As of June 30, 2008, the Company had outstanding purchase
commitments related to inventory totaling approximately
$3.5 million.
Co-promotion
Agreements
In February 2006, the Company signed a co-promotion agreement
with Ascend Therapeutics, Inc. (Ascend) to provide
detailing of a product to a specific physician population. As
compensation, the Company paid a fee for detailing the product
equal to 50% of net sales. This agreement was terminated in
March 2008.
In March 2007 and June 2007, the Company entered into
co-promotion agreements with SJ Pharmaceuticals, LLC (SJ
Pharmaceuticals) to co-promote two of the Companys
product lines. Under these agreements, the Company pays SJ
Pharmaceuticals fees based on a percentage of the net profits of
the products sold above a specified baseline based upon
prescriptions by assigned, targeted prescribers within assigned
sales territories. These targeted prescribers are mutually
agreed upon by the Company and SJ Pharmaceuticals prior to the
start of each quarter.
In April 2007, the Company entered into a co-promotion agreement
with Atley Pharmaceuticals, Inc. (Atley
Pharmaceuticals) as subsequently amended, to co-promote a
prescription pain product beginning July 1, 2007.
F-105
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Under this agreement, the Company pays Atley Pharmaceuticals
fees based on a percentage of the net profits from sales of the
product above a specified baseline within assigned sales
territories.
Each of these co-promotion agreements is subject to
sunset fees that require the Company to pay
additional fees for up to one year in the event of certain
defined terminations of the agreements.
Sales and
Marketing Agreement
In September 2005, the Company entered into a sales and
marketing agreement with Pliva, Inc. (Pliva). Under
this agreement, the Company receives all revenues, less usual
and customary discounts and a distribution fee to Pliva
calculated as a percentage of net revenues that Pliva generates
on sales of Propoxyphene-APAP
100-500. The
current term of the agreement expires December 31, 2008.
The Company has given Pliva notice that at the end of the
current term the Company will terminate the agreement.
Settlements
Adams
Respiratory Therapeutics, Inc.
In October 2004, the Company was included as a defendant in
litigation with a related party, Carolina Pharmaceuticals, Inc.,
by Adams Respiratory Therapeutics, Inc. (Adams) that
alleged trademark infringement, false advertising and unfair
competition claims and sought damages and injunctive relief. The
Company vigorously defended these allegations and filed various
counterclaims. In January 2005, Adams and the Company entered
into an agreement under which in February 2005 the Company
received all of the rights to the ALLERX products held by Adams
and Adams received all of the rights to the Humibid family of
products held by the Company. Additionally, the parties released
each other from all claims and damages in the above mentioned
lawsuit. The agreement required the Company to assume the
financial responsibility for the first $1.0 million of
returned Humibid product that was sold by the Company prior to
February 15, 2005 and returned to Adams during the
18-month
period beginning February 15, 2005. Conversely, Adams was
financially responsible for the first $1.0 million of
ALLERX product returns for the same
18-month
period. After the
18-month
period or the $1.0 million threshold is met, the agreement
provided that the Company would have the responsibility for all
ALLERX product returns whether sold by the Company or Adams and
Adams would bear the same liability for Humibid products. In
connection with this agreement, Adams is obligated to pay the
Company a royalty ranging from 1% to 2% of net Humibid
sales for a period of three years after February 15, 2005
with a minimum annual royalty of $50,000.
In 2006, a major wholesaler indicated that it was in possession
of a significant amount of Humibid prescription inventory. Adams
filed a complaint alleging that the Company and Carolina
Pharmaceuticals, Inc. did not disclose the outstanding inventory
in accordance with the prior agreement and are therefore
financially responsible for the returns. The Company and
Carolina Pharmaceuticals, Inc. believed they were not liable for
these returns under the agreement and filed a counterclaim.
Since all Humibid prescription products were sold by Carolina
Pharmaceuticals, Inc., the Company did not accrue any amounts
related to this claim.
In May 2008, the Company settled the dispute with Adams. The
agreement provides that all parties to the settlement are to be
released from all legal claims made prior to January 2008 and
that the Company and Carolina Pharmaceuticals, Inc. shall pay to
Reckitt Benckiser, Inc., the parent of Adams, $1.5 million
in three installments to be paid as follows: $500,000 by
June 20, 2008; $500,000 by June 30, 2008; and $500,000
by September 30, 2008. In exchange, the Company is released
from all liabilities. The total net amount accrued on the
Companys consolidated balance sheet as of June 30,
2008 was $290,000, which the Company expects to pay on
September 30, 2008. Carolina Pharmaceuticals, Inc. will
make the remaining payment of $210,000.
F-106
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Others
In November 2006, the Company filed a legal complaint against a
pharmaceutical company, certain affiliates of the pharmaceutical
company and the manufacturer of a product launched by the
pharmaceutical company that the Company believed infringed upon
the patent of one of its products. By January 2007, the disputes
with all involved parties were settled. The terms of the
settlements required the parties to admit and acknowledge that
the claims of the patent are valid and enforceable and covenant
that the parties will not infringe on the claims of the patent
by making, using, selling or offering for sale any product that
would infringe on the patent. The settlements provided that the
Company pay the parties for the value of certain inventory on
hand, which was destroyed. The Company accrued approximately
$256,000 in 2006 related to these potential inventory purchases.
The total actual inventory payments made related to the
settlement in 2007 amounted to $236,000, and the excess accrual
of $20,000 was reversed as of December 31, 2007.
In addition, as part of the settlement, the Company also
committed to pay $75,000 for trademark rights. The Company also
made this payment in 2007.
In response to a claim of infringement filed by the Company in
early 2008, a pharmaceutical company has filed a counterclaim
that the patent, which is licensed to the Company, is invalid
and moved to stay the litigation pending the re-examination of
the Companys patent. No monetary relief has been requested
in the counterclaim. The court granted defendants motion
and stayed the litigation pending the re-examination of the
Companys patent in February 2008. Separately, the
U.S. Patent and Trademark Office ordered a re-examination
of the patent. Additionally, in June 2008, the pharmaceutical
company requested that the U.S. Patent and Trademark Office
re-examine a related second patent licensed to the Company by an
affiliate of the licensor of the first patent, which is not at
issue in the litigation. In concert with the licensor of the
patents, the Company intends to vigorously pursue its claims and
defend the counterclaim. The Companys intellectual
property counsel has concluded that valid arguments exist for
distinguishing the claims of the Companys patents over the
references cited in the requests for re-examination. If the
United States Patent and Trademark Office invalidates some or
all of the claims under these patents, the Company could be
exposed to increased generic competition relating to its various
day-night products, and its future operating and financial
results could be adversely affected. Because no monetary relief
has been requested in the counterclaim, no amount has been
accrued in these consolidated financial statements.
Product
Agreements
In August 2006, the Company loaned Neos $500,000 under a secured
subordinated promissory note agreement. In December 2006, the
Company entered into a product development agreement with Neos
providing the Company with an exclusive license to certain
products under development utilizing Neoss time release
suspension technology. Under the terms of the agreement, the
note with Neos was forgiven. The Company has recorded the
$500,000 consideration as product rights related to the time
release suspension technology. The agreement requires Neos to
develop each product at its own expense up to a defined
milestone. After that milestone is achieved, the Company is
required to reimburse Neos 110% of all direct costs incurred and
pay $150 per hour for personnel time incurred in the development
of the products. The Company will also make milestone payments
up to $1.0 million for each product based on specific
events. As of June 30, 2008, Cornerstone had accrued
$69,000 in development costs and had not made any milestone
payments. Upon commercialization, the Company would also pay
Neos royalties based on a percentage of net sales.
During 2007, the Company entered various research and
development agreements. As of June 30, 2008, the Company
had outstanding commitments related to ongoing research and
development contracts totaling $805,000.
F-107
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Severance
Selected executive employees of the Company have employment
agreements which provide for severance payments ranging from
three to 12 months of salary and benefits upon termination,
depending on the reasons for the termination. The executive
would also be required to execute a release and settlement
agreement. No amount has been accrued for severance as of
June 30, 2008.
|
|
NOTE 12:
|
PROPOSED
MERGER WITH CRITICAL THERAPEUTICS
|
On May 1, 2008, the Company and Critical Therapeutics
entered into a merger agreement pursuant to which Neptune
Acquisition Corp., a wholly owned subsidiary of Critical
Therapeutics, will merge with and into the Company (the
Merger), with the Company continuing after the
merger as the surviving company and a wholly owned subsidiary of
Critical Therapeutics (the Merger Agreement). If the
Merger is completed, at the effective time of the Merger, all
outstanding shares of the Companys common stock will be
converted into and exchanged for shares of Critical
Therapeutics common stock, and all outstanding options,
whether vested or unvested, and all outstanding warrants to
purchase the Companys common stock will be assumed by
Critical Therapeutics and become options and warrants to
purchase Critical Therapeutics common stock. The Merger
Agreement provides that, at the effective time of the Merger,
Critical Therapeutics will issue to the Companys
stockholders, and assume the Companys options and warrants
that will represent, an aggregate of approximately
101.5 million shares of Critical Therapeutics common
stock, subject to adjustment as a result of a contemplated
reverse stock split of Critical Therapeutics common stock
to occur in connection with the Merger. Immediately following
the effective time of the Merger, the Companys
stockholders will own approximately 70%, and Critical
Therapeutics stockholders will own approximately 30%, of
Critical Therapeutics common stock, assuming the exchange
or conversion prior to the merger of the outstanding principal
amount of the Carolina Note into shares of Cornerstones
common stock and after giving effect to shares issuable pursuant
to the Companys outstanding options and warrants, but
without giving effect to any shares issuable pursuant to
Critical Therapeutics outstanding options and warrants.
The exchange ratio per share of the Companys common stock
will be based on the number of shares of the Companys
common stock outstanding on a fully diluted basis immediately
prior to the effective time of the Merger and will not be
determined until that time.
The consummation of the Merger is subject to a number of closing
conditions, including the approval of both the Companys
stockholders and Critical Therapeutics stockholders,
approval by The NASDAQ Stock Market LLC of Critical
Therapeutics application for re-listing of its common
stock in connection with the Merger, the continued availability
of its products and other customary closing conditions. As a
condition to the Merger, Carolina Pharmaceuticals has entered
into an agreement that provides, among other things, for the
exchange or conversion of the outstanding principal amount of
the Carolina Note into shares of the Companys common stock
prior to the effective time of the merger. The Company is
targeting a closing of the transaction in the fourth quarter of
2008.
F-108
CORNERSTONE
BIOPHARMA HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
(Unaudited)
Immediately prior to the effective time of the Merger, Critical
Therapeutics has agreed to effect a reverse stock split of its
common stock whereby each issued and outstanding share of its
common stock will be reclassified and combined into a fractional
number of shares of common stock. The reverse stock split ratio
is to be mutually agreed upon by the Company and Critical
Therapeutics. The reverse stock split is necessary so that as of
the effective time of the Merger Critical Therapeutics will
satisfy the minimum bid price requirement pursuant to the
initial listing standards for The NASDAQ Capital Market.
The Merger Agreement provides for the payment of a termination
fee of $1.0 million by each of the Company and Critical
Therapeutics to the other party in specified circumstances in
connection with the termination of the Merger Agreement. In
addition, in specified circumstances in connection with
termination of the Merger Agreement, Critical Therapeutics has
agreed to reimburse the Company for up to $150,000 in expenses
and the Company has agreed to reimburse Critical Therapeutics
for up to $100,000 in expenses.
|
|
NOTE 13:
|
SUBSEQUENT
EVENTS
|
On August 20, 2008, the Company entered into an employment
agreement and a restricted stock agreement with its newly hired
Executive Vice President, Finance, and Chief Financial Officer
(CFO). The CFOs employment with the Company
will commence on September 8, 2008. Pursuant to the
restricted stock agreement, the Company agreed to issue the CFO
1,301,776 shares of restricted stock in the Company. The
Company plans to issue the restricted stock immediately prior to
the consummation of the proposed merger with Critical
Therapeutics. The restricted stock will vest 25% on each of the
first four anniversaries of August 20, 2008.
F-109
TABLE OF
CONTENTS
|
|
|
|
|
|
|
|
|
|
|
Page
|
|
ARTICLE I THE MERGER
|
|
|
A-9
|
|
1.1
|
|
Effective Time of the Merger
|
|
|
A-9
|
|
1.2
|
|
Closing
|
|
|
A-9
|
|
1.3
|
|
Effects of the Merger
|
|
|
A-9
|
|
1.4
|
|
Certificate of Incorporation; Bylaws
|
|
|
A-9
|
|
1.5
|
|
Directors and Officers of the Surviving Corporation
|
|
|
A-9
|
|
|
|
|
|
|
ARTICLE II CONVERSION OF SECURITIES
|
|
|
A-10
|
|
2.1
|
|
Reverse Split of Public Company Common Stock
|
|
|
A-10
|
|
2.2
|
|
Conversion of Capital Stock
|
|
|
A-10
|
|
2.3
|
|
Exchange of Certificates
|
|
|
A-11
|
|
2.4
|
|
Merger Partner Stock Plans and Merger Partner Warrants
|
|
|
A-13
|
|
2.5
|
|
Dissenting Shares
|
|
|
A-14
|
|
|
|
|
|
|
ARTICLE III REPRESENTATIONS AND
WARRANTIES OF MERGER PARTNER
|
|
|
A-14
|
|
3.1
|
|
Organization, Standing and Power
|
|
|
A-15
|
|
3.2
|
|
Capitalization
|
|
|
A-15
|
|
3.3
|
|
Subsidiaries
|
|
|
A-17
|
|
3.4
|
|
Authority; No Conflict; Required Filings and Consents
|
|
|
A-18
|
|
3.5
|
|
Merger Partner Financial Statements; Information Provided
|
|
|
A-19
|
|
3.6
|
|
No Undisclosed Liabilities
|
|
|
A-20
|
|
3.7
|
|
Absence of Certain Changes or Events
|
|
|
A-20
|
|
3.8
|
|
Taxes
|
|
|
A-20
|
|
3.9
|
|
Owned and Leased Real Properties
|
|
|
A-22
|
|
3.10
|
|
Intellectual Property
|
|
|
A-22
|
|
3.11
|
|
Contracts
|
|
|
A-24
|
|
3.12
|
|
Litigation
|
|
|
A-25
|
|
3.13
|
|
Environmental Matters
|
|
|
A-25
|
|
3.14
|
|
Employee Benefit Plans
|
|
|
A-26
|
|
3.15
|
|
Compliance With Laws
|
|
|
A-28
|
|
3.16
|
|
Permits and Regulatory Matters
|
|
|
A-28
|
|
3.17
|
|
Employees
|
|
|
A-29
|
|
3.18
|
|
Insurance
|
|
|
A-30
|
|
3.19
|
|
No Existing Discussions
|
|
|
A-30
|
|
3.20
|
|
Brokers; Fees and Expenses
|
|
|
A-30
|
|
3.21
|
|
Controls and Procedures, Certifications and Other Matters
Relating to the Sarbanes Act
|
|
|
A-30
|
|
3.22
|
|
Certain Business Relationships With Affiliates
|
|
|
A-31
|
|
3.23
|
|
Books and Records
|
|
|
A-31
|
|
|
|
|
|
|
ARTICLE IV REPRESENTATIONS AND
WARRANTIES OF PUBLIC COMPANY AND THE TRANSITORY SUBSIDIARY
|
|
|
A-31
|
|
4.1
|
|
Organization, Standing and Power
|
|
|
A-31
|
|
4.2
|
|
Capitalization
|
|
|
A-32
|
|
4.3
|
|
Subsidiaries
|
|
|
A-33
|
|
4.4
|
|
Authority; No Conflict; Required Filings and Consents
|
|
|
A-34
|
|
4.5
|
|
SEC Filings; Financial Statements; Information Provided
|
|
|
A-35
|
|
4.6
|
|
No Undisclosed Liabilities
|
|
|
A-37
|
|
4.7
|
|
Absence of Certain Changes or Events
|
|
|
A-37
|
|
4.8
|
|
Taxes
|
|
|
A-37
|
|
A-2
|
|
|
|
|
|
|
4.9
|
|
Owned and Leased Real Properties
|
|
|
A-38
|
|
4.10
|
|
Intellectual Property
|
|
|
A-39
|
|
4.11
|
|
Agreements, Contracts and Commitments
|
|
|
A-39
|
|
4.12
|
|
Litigation
|
|
|
A-40
|
|
4.13
|
|
Environmental Matters
|
|
|
A-41
|
|
4.14
|
|
Employee Benefit Plans
|
|
|
A-41
|
|
4.15
|
|
Compliance With Laws
|
|
|
A-43
|
|
4.16
|
|
Permits and Regulatory Matters
|
|
|
A-43
|
|
4.17
|
|
Employees
|
|
|
A-44
|
|
4.18
|
|
Insurance
|
|
|
A-44
|
|
4.19
|
|
No Existing Discussions
|
|
|
A-45
|
|
4.20
|
|
Opinion of Financial Advisor
|
|
|
A-45
|
|
4.21
|
|
Section 203 of the DGCL Not Applicable
|
|
|
A-45
|
|
4.22
|
|
Brokers; Fees and Expenses
|
|
|
A-45
|
|
4.23
|
|
Operations of the Transitory Subsidiary
|
|
|
A-45
|
|
4.24
|
|
Controls and Procedures, Certifications and Other Matters
Relating to the Sarbanes Act
|
|
|
A-45
|
|
|
|
|
|
|
ARTICLE V CONDUCT OF BUSINESS
|
|
|
A-46
|
|
5.1
|
|
Covenants of Merger Partner
|
|
|
A-46
|
|
5.2
|
|
Covenants of Public Company
|
|
|
A-48
|
|
5.3
|
|
Confidentiality
|
|
|
A-51
|
|
|
|
|
|
|
ARTICLE VI ADDITIONAL AGREEMENTS
|
|
|
A-51
|
|
6.1
|
|
No Solicitation
|
|
|
A-51
|
|
6.2
|
|
Proxy Statement/Prospectus; Registration Statement
|
|
|
A-53
|
|
6.3
|
|
NASDAQ Listing
|
|
|
A-54
|
|
6.4
|
|
Access to Information
|
|
|
A-54
|
|
6.5
|
|
Stockholder Approval
|
|
|
A-54
|
|
6.6
|
|
Legal Conditions to Merger
|
|
|
A-55
|
|
6.7
|
|
Public Disclosure
|
|
|
A-56
|
|
6.8
|
|
Section 368(a) Reorganization
|
|
|
A-56
|
|
6.9
|
|
D&O Insurance; Indemnification
|
|
|
A-57
|
|
6.10
|
|
Notification of Certain Matters
|
|
|
A-57
|
|
6.11
|
|
Headquarters of Public Company
|
|
|
A-58
|
|
6.12
|
|
Corporate Identity
|
|
|
A-58
|
|
6.13
|
|
Succession
|
|
|
A-58
|
|
6.14
|
|
Board of Directors of Public Company
|
|
|
A-58
|
|
6.15
|
|
Employee Communications
|
|
|
A-58
|
|
6.16
|
|
FIRPTA Tax Certificates
|
|
|
A-58
|
|
|
|
|
|
|
ARTICLE VII CONDITIONS TO MERGER
|
|
|
A-58
|
|
7.1
|
|
Conditions to Each Partys Obligation To Effect the
Merger
|
|
|
A-58
|
|
7.2
|
|
Additional Conditions to the Obligations of Public Company
and the Transitory Subsidiary
|
|
|
A-59
|
|
7.3
|
|
Additional Conditions to the Obligations of Merger Partner
|
|
|
A-60
|
|
|
|
|
|
|
ARTICLE VIII TERMINATION AND AMENDMENT
|
|
|
A-62
|
|
8.1
|
|
Termination
|
|
|
A-62
|
|
8.2
|
|
Effect of Termination
|
|
|
A-63
|
|
8.3
|
|
Fees and Expenses
|
|
|
A-64
|
|
8.4
|
|
Amendment
|
|
|
A-65
|
|
8.5
|
|
Extension; Waiver
|
|
|
A-65
|
|
A-3
|
|
|
|
|
|
|
ARTICLE IX MISCELLANEOUS
|
|
|
A-65
|
|
9.1
|
|
Nonsurvival of Representations, Warranties and Agreements
|
|
|
A-65
|
|
9.2
|
|
Notices
|
|
|
A-65
|
|
9.3
|
|
Entire Agreement
|
|
|
A-66
|
|
9.4
|
|
No Third Party Beneficiaries
|
|
|
A-66
|
|
9.5
|
|
Assignment
|
|
|
A-66
|
|
9.6
|
|
Severability
|
|
|
A-66
|
|
9.7
|
|
Counterparts and Signature
|
|
|
A-67
|
|
9.8
|
|
Interpretation
|
|
|
A-67
|
|
9.9
|
|
Governing Law
|
|
|
A-67
|
|
9.10
|
|
Remedies
|
|
|
A-67
|
|
9.11
|
|
Submission to Jurisdiction
|
|
|
A-67
|
|
9.12
|
|
WAIVER OF JURY TRIAL
|
|
|
A-68
|
|
9.13
|
|
Operating Company Guarantee
|
|
|
A-68
|
|
|
|
|
|
|
|
|
Schedule A-1
|
|
Merger Partner Key Stockholders
|
|
|
A-70
|
|
Schedule A-2
|
|
Public Company Key Stockholders
|
|
|
A-71
|
|
Schedule 6.13
|
|
Officer Appointments
|
|
|
A-72
|
|
Schedule 6.14(a)
|
|
Director Appointments
|
|
|
A-73
|
|
Schedule 6.14(b)
|
|
Director Resignations
|
|
|
A-74
|
|
Exhibit A-1
|
|
Form of Merger Partner Stockholder Agreement
|
|
|
A-75
|
|
Exhibit A-2
|
|
Form of Merger Partner Noteholder Agreement
|
|
|
A-84
|
|
Exhibit A-3
|
|
Form of Public Company Stockholder Agreement
|
|
|
A-94
|
|
Exhibit B
|
|
Form of Certificate of Incorporation of the Surviving Corporation
|
|
|
A-102
|
|
A-4
TABLE OF
DEFINED TERMS
|
|
|
|
|
|
|
Cross Reference
|
Terms
|
|
in Agreement
|
|
Acquisition Proposal
|
|
|
Section 6.1(f)
|
|
Adjusted Warrant
|
|
|
Section 2.4(e)
|
|
Affiliate
|
|
|
Section 3.2(e)
|
|
Agreement
|
|
|
Preamble
|
|
Antitrust Laws
|
|
|
Section 6.6(b)
|
|
Bankruptcy and Equity Exception
|
|
|
Section 3.4(a)
|
|
Carolina Note
|
|
|
Preamble
|
|
Carolina Pharmaceuticals Bermuda
|
|
|
Preamble
|
|
Certificate of Merger
|
|
|
Section 1.1
|
|
Certificates
|
|
|
Section 2.3(a)
|
|
Closing
|
|
|
Section 1.2
|
|
Closing Date
|
|
|
Section 1.2
|
|
Code
|
|
|
Preamble
|
|
Comparable Product
|
|
|
Section 3.16(e)
|
|
Confidentiality Agreement
|
|
|
Section 5.3
|
|
DGCL
|
|
|
Preamble
|
|
Dissenting Shares
|
|
|
Section 2.2(c)
|
|
Effective Time
|
|
|
Section 1.1
|
|
Employee Benefit Plan
|
|
|
Section 3.14(l)(i)
|
|
Environmental Law
|
|
|
Section 3.13(b)
|
|
ERISA
|
|
|
Section 3.14(l)(ii)
|
|
ERISA Affiliate
|
|
|
Section 3.14(l)(iii)
|
|
Exchange Act
|
|
|
Section 3.4(c)
|
|
Exchange Agent
|
|
|
Section 2.3(a)
|
|
Exchange Fund
|
|
|
Section 2.3(a)
|
|
Exchange Ratio
|
|
|
Section 2.2(c)
|
|
FDA
|
|
|
Section 3.16(a)
|
|
GAAP
|
|
|
Section 3.5(a)
|
|
Governmental Entity
|
|
|
Section 3.4(c)
|
|
Hazardous Substance
|
|
|
Section 3.13(c)
|
|
HSR Act
|
|
|
Section 6.6(a)
|
|
Indemnified Parties
|
|
|
Section 6.9(b)
|
|
Intellectual Property
|
|
|
Section 3.10(e)(i)
|
|
IRS
|
|
|
Section 3.8(b)
|
|
Lazard
|
|
|
Section 4.20
|
|
Lien
|
|
|
Section 3.4(b)
|
|
Merger
|
|
|
Preamble
|
|
Merger Partner
|
|
|
Preamble
|
|
Merger Partner Authorizations
|
|
|
Section 3.16(a)
|
|
Merger Partner Balance Sheet
|
|
|
Section 3.5(a)
|
|
Merger Partner Balance Sheet Date
|
|
|
Section 3.5(a)
|
|
Merger Partner Board
|
|
|
Preamble
|
|
Merger Partner Common Stock
|
|
|
Preamble
|
|
Merger Partner Counsel
|
|
|
Section 7.3(d)
|
|
Merger Partner Disclosure Schedule
|
|
|
Article III
|
|
Merger Partner Employee Plans
|
|
|
Section 3.14(a)
|
|
Merger Partner Financial Statements
|
|
|
Section 3.5(a)
|
|
Merger Partner Insurance Policies
|
|
|
Section 3.18
|
|
A-5
|
|
|
|
|
|
|
Cross Reference
|
Terms
|
|
in Agreement
|
|
Merger Partner Intellectual Property
|
|
|
Section 3.10(b)
|
|
Merger Partner Leases
|
|
|
Section 3.9(b)
|
|
Merger Partner Material Adverse Effect
|
|
|
Section 3.1
|
|
Merger Partner Noteholder Agreement
|
|
|
Preamble
|
|
Merger Partner Stock Options
|
|
|
Section 2.4(a)
|
|
Merger Partner Stock Plans
|
|
|
Section 2.4(a)
|
|
Merger Partner Stockholder Agreements
|
|
|
Preamble
|
|
Merger Partner Stockholder Approval
|
|
|
Section 3.4(a)
|
|
Merger Partner Third Party Intellectual Property
|
|
|
Section 3.10(b)
|
|
Merger Partner Voting Proposal
|
|
|
Section 3.4(a)
|
|
Merger Partner Warrants
|
|
|
Section 3.2(d)
|
|
NASDAQ
|
|
|
Section 2.1(b)
|
|
New Merger Partner Audit Firm
|
|
|
Section 3.5(b)
|
|
Operating Company
|
|
|
Preamble
|
|
Ordinary Course of Business
|
|
|
Section 3.3(d)
|
|
Outside Date
|
|
|
Section 8.1(b)
|
|
Patent Rights
|
|
|
Section 3.10(e)(ii)
|
|
Proxy Statement/Prospectus
|
|
|
Section 3.5(c)
|
|
Public Company
|
|
|
Preamble
|
|
Public Company Authorizations
|
|
|
Section 4.16(a)
|
|
Public Company Balance Sheet
|
|
|
Section 4.5(b)
|
|
Public Company Board
|
|
|
Preamble
|
|
Public Company Charter Amendment
|
|
|
Section 2.1(a)
|
|
Public Company Common Stock
|
|
|
Section 2.1(a)(i)
|
|
Public Company Disclosure Schedule
|
|
|
Article IV
|
|
Public Company Employee Plans
|
|
|
Section 4.14(a)
|
|
Public Company
Form 10-K
|
|
|
Section 4.5(b)
|
|
Public Company Insurance Policies
|
|
|
Section 4.18
|
|
Public Company Intellectual Property
|
|
|
Section 4.10(b)
|
|
Public Company Leases
|
|
|
Section 4.9(b)
|
|
Public Company Material Adverse Effect
|
|
|
Section 4.1
|
|
Public Company Material Contracts
|
|
|
Section 4.11(a)
|
|
Public Company Meeting
|
|
|
Section 3.5(c)
|
|
Public Company Preferred Stock
|
|
|
Section 4.2(a)
|
|
Public Company Recent SEC Documents
|
|
|
Section 4.6
|
|
Public Company SEC Documents
|
|
|
Section 4.5(a)
|
|
Public Company Stock Options
|
|
|
Section 4.2(c)
|
|
Public Company Stock Plans
|
|
|
Section 4.2(c)
|
|
Public Company Stockholder Agreements
|
|
|
Preamble
|
|
Public Company Stockholder Approval
|
|
|
Section 3.5(c)
|
|
Public Company Third Party Intellectual Property
|
|
|
Section 4.10(b)
|
|
Public Company Voting Proposals
|
|
|
Section 3.5(c)
|
|
Public Company Warrants
|
|
|
Section 4.2(c)
|
|
Registration Statement
|
|
|
Section 3.5(d)
|
|
Regulation M-A
Filing
|
|
|
Section 3.5(c)
|
|
Representatives
|
|
|
Section 6.1(a)
|
|
Reverse Stock Split
|
|
|
Section 2.1(a)(i)
|
|
Sarbanes Act
|
|
|
Section 4.5(a)
|
|
SEC
|
|
|
Section 3.4(c)
|
|
Securities Act
|
|
|
Section 3.2(e)
|
|
A-6
|
|
|
|
|
|
|
Cross Reference
|
Terms
|
|
in Agreement
|
|
Specified Time
|
|
|
Section 6.1(a)(ii)
|
|
Subsidiary
|
|
|
Section 3.3(a)
|
|
Superior Proposal
|
|
|
Section 6.1(f)
|
|
Surviving Corporation
|
|
|
Section 1.3
|
|
Tax Returns
|
|
|
Section 3.8(a)
|
|
Taxes
|
|
|
Section 3.8(a)
|
|
Trademarks
|
|
|
Section 3.10(e)(iii)
|
|
Transitory Subsidiary
|
|
|
Preamble
|
|
WilmerHale
|
|
|
Section 7.2(d)
|
|
Written Consents
|
|
|
Section 3.4(d)
|
|
A-7
AGREEMENT
AND PLAN OF MERGER
THIS AGREEMENT AND PLAN OF MERGER (this
Agreement), dated as of May 1, 2008, is
by and among Critical Therapeutics, Inc., a Delaware corporation
(Public Company), Neptune Acquisition Corp.,
a Delaware corporation and a wholly owned subsidiary of Public
Company (the Transitory Subsidiary), and
Cornerstone BioPharma Holdings, Inc., a Delaware corporation
(Merger Partner).
WHEREAS, the Board of Directors of Public Company (the
Public Company Board) and the Board of
Directors of Merger Partner (the Merger Partner
Board) each deem it advisable and in the best
interests of their respective corporation and its stockholders
that Public Company and Merger Partner combine in order to
advance the long-term business interests of Public Company and
Merger Partner;
WHEREAS, the combination of Public Company and Merger Partner
shall be effected through a merger (the
Merger) of the Transitory Subsidiary into
Merger Partner in accordance with the terms of this Agreement
and the General Corporation Law of the State of Delaware (the
DGCL), as a result of which Merger Partner
will become a wholly owned subsidiary of Public Company;
WHEREAS, concurrently with the execution and delivery of this
Agreement and as a condition and inducement to Public
Companys willingness to enter into this Agreement, the
stockholders of Merger Partner listed on
Schedule A-1
to this Agreement have entered into Stockholder Agreements,
dated as of the date of this Agreement, in the form attached
hereto as
Exhibit A-1
(the Merger Partner Stockholder Agreements),
pursuant to which such stockholders have, among other things,
agreed (i) to give Public Company a proxy to vote all of
the shares of capital stock of Merger Partner that such
stockholders own and (ii) not to transfer or otherwise
dispose of any shares of capital stock of Merger Partner that
such stockholders own or, for 180 days after the Effective
Time, any Public Company Common Stock received in exchange
therefor pursuant to the Merger;
WHEREAS, concurrently with the execution and delivery of this
Agreement and as a condition and inducement to Public
Companys willingness to enter into this Agreement,
Carolina Pharmaceuticals Ltd., a Bermuda Exempted Company
(Carolina Pharmaceuticals Bermuda), the
holder of that certain Promissory Note, dated April 19,
2004, with Cornerstone BioPharma, Inc., a Nevada corporation and
a wholly owned subsidiary of Merger Partner (Operating
Company), as amended by that certain Promissory Note
Amendment and Waiver Agreement, dated June 6, 2006 (as
amended, the Carolina Note), has entered into
a Noteholder Agreement, dated as of the date of this Agreement,
in the form attached hereto as
Exhibit A-2
(the Merger Partner Noteholder Agreement),
pursuant to which Carolina Pharmaceuticals Bermuda, among other
things, has agreed (i) to exchange or convert the Carolina
Note into the common stock, $0.0001 par value per share, of
Merger Partner (the Merger Partner Common
Stock) prior to the Effective Time in accordance with
the terms of the Merger Partner Noteholder Agreement,
(ii) to give Public Company a proxy to vote all of the
shares of capital stock of Merger Partner that Carolina
Pharmaceuticals Bermuda owns and (iii) not to transfer or
otherwise dispose of any shares of Merger Partner Common Stock
that Carolina Pharmaceuticals Bermuda owns or, for 180 days
after the Effective Time, any Public Company Common Stock
received in exchange therefor pursuant to the Merger;
WHEREAS, concurrently with the execution and delivery of this
Agreement and as a condition and inducement to Merger
Partners willingness to enter into this Agreement, the
stockholders of Public Company listed on
Schedule A-2
to this Agreement have entered into Stockholder Agreements,
dated as of the date of this Agreement, in the form attached
hereto as
Exhibit A-3
(the Public Company Stockholder Agreements),
pursuant to which such stockholders have, among other things,
agreed to give Merger Partner a proxy to vote all of the shares
of capital stock of Public Company that such stockholders own;
WHEREAS, for United States federal income tax purposes, it is
intended that the Merger shall qualify as a reorganization
within the meaning of Section 368(a) of the Internal
Revenue Code of 1986, as amended (the Code);
A-8
NOW, THEREFORE, in consideration of the foregoing and the
respective representations, warranties, covenants and agreements
set forth below, Public Company, the Transitory Subsidiary and
Merger Partner agree as follows:
ARTICLE I
THE
MERGER
1.1 Effective Time of the
Merger. Subject to the provisions of this
Agreement, prior to the Closing, Public Company shall prepare
(in a form reasonably acceptable to Merger Partner), and on the
Closing Date or as soon as practicable thereafter Public Company
and Merger Partner shall cause to be filed with the Secretary of
State of the State of Delaware, a certificate of merger (the
Certificate of Merger) in such form as is
required by, and executed by the Surviving Corporation in
accordance with, the relevant provisions of the DGCL and shall
make all other filings or recordings required under the DGCL.
The Merger shall become effective upon the filing of the
Certificate of Merger with the Secretary of State of the State
of Delaware or at such later time as is established by Public
Company and Merger Partner and set forth in the Certificate of
Merger (the Effective Time). The Certificate
of Merger shall provide that the name of the Surviving
Corporation as of and after the Effective Time shall be
Cornerstone BioPharma Holdings, Inc.
1.2 Closing. The
closing of the Merger (the Closing) will take
place at 10:00 a.m., Eastern time, on a date to be
specified by Public Company and Merger Partner (the
Closing Date), which shall be no later than
the second business day after satisfaction or waiver of the
conditions set forth in Article VII (other than delivery of
items to be delivered at the Closing and other than satisfaction
of those conditions that by their nature are to be satisfied at
the Closing, it being understood that the occurrence of the
Closing shall remain subject to the delivery of such items and
the satisfaction or waiver of such conditions at the Closing),
at the offices of Smith, Anderson, Blount, Dorsett,
Mitchell & Jernigan, L.L.P., 2500 Wachovia Capitol
Center, Raleigh, NC 27601, unless another date, place or time is
agreed to in writing by Public Company and Merger Partner. It is
the intention of the parties that the Closing shall occur as
soon as practicable after the Public Company Meeting.
1.3 Effects of the
Merger. At the Effective Time, the separate
existence of the Transitory Subsidiary shall cease and the
Transitory Subsidiary shall be merged with and into Merger
Partner (Merger Partner following the Merger is sometimes
referred to herein as the Surviving
Corporation), and the Merger shall have the effects
set forth in the DGCL.
1.4 Certificate of Incorporation;
Bylaws.
(a) The Certificate of Incorporation of
the Surviving Corporation shall be amended at the Effective Time
in its entirety to read in the form attached hereto as
Exhibit B.
(b) The Bylaws of the Surviving
Corporation immediately following the Effective Time shall be
the same as the Bylaws of the Transitory Subsidiary immediately
prior to the Effective Time, except that the name of the
corporation set forth therein shall be changed to
Cornerstone BioPharma Holdings, Inc.
1.5 Directors and Officers of the
Surviving Corporation.
(a) The directors of Merger Partner
immediately prior to the Effective Time shall be the initial
directors of the Surviving Corporation, each to hold office in
accordance with the Certificate of Incorporation and Bylaws of
the Surviving Corporation.
(b) The officers of Merger Partner
immediately prior to the Effective Time shall be the initial
officers of the Surviving Corporation, each to hold office in
accordance with the Certificate of Incorporation and Bylaws of
the Surviving Corporation.
A-9
ARTICLE II
CONVERSION
OF SECURITIES
2.1 Reverse Split of Public Company
Common Stock.
(a) Immediately prior to the Effective
Time, and subject to receipt of the Public Company Stockholder
Approval, Public Company shall cause to be filed a Certificate
of Amendment to its Certificate of Incorporation (the
Public Company Charter Amendment), whereby,
upon the effectiveness of filing of the Public Company Charter
Amendment, without any further action on the part of Public
Company, Merger Partner or any stockholder of Public Company:
(i) Each share of common stock,
$0.001 par value per share, of Public Company
(Public Company Common Stock) issued and
outstanding immediately prior to the effective time specified in
the Public Company Charter Amendment shall be reclassified and
combined into and become a fractional number of fully paid and
nonassessable shares of Public Company Common Stock to be
mutually agreed upon by Public Company and Merger Partner (the
Reverse Stock Split).
(ii) Any shares of Public Company Common
Stock held as treasury stock or owned by Public Company
immediately prior to the filing of the Public Company Charter
Amendment shall each be reclassified and combined into and
become an identical fractional number of shares of Public
Company Common Stock as determined by the Board of Directors of
Public Company in connection with Section 2.1(a)(i).
(b) No certificates or scrip representing
fractional shares of Public Company Common Stock shall be issued
in connection with the Reverse Stock Split. Each holder of
shares of Public Company Common Stock who would otherwise have
been entitled to receive a fraction of a share of Public Company
Common Stock (after taking into account all fractional shares of
Public Company Common Stock otherwise issuable to such holder)
shall be entitled to receive, in lieu thereof, upon surrender of
such holders certificate(s) representing such fractional
shares of Public Company Common Stock, cash (without interest)
in an amount equal to such fractional part of a share of Public
Company Common Stock multiplied by the average last reported
sales prices of Public Company Common Stock at the
4:00 p.m., Eastern time, end of regular trading hours on
The NASDAQ Stock Market LLC (NASDAQ) during
the ten consecutive trading days ending on the last trading day
prior to the Effective Time.
(c) To give effect to, and as of the
effective time of, the Reverse Stock Split, Public Company shall
adjust and proportionately decrease the number of shares of
Public Company Common Stock reserved for issuance upon exercise
of, and adjust and proportionately increase the exercise price
of, all options, warrants and other rights to acquire Public
Company Common Stock.
(d) The Exchange Ratio shall be
appropriately adjusted at the Effective Time to reflect fully
the effect of the Reverse Stock Split.
2.2 Conversion of Capital
Stock. As of the Effective Time, by virtue of the
Merger and without any action on the part of the holder of any
shares of the capital stock of Merger Partner or the holder of
any shares of the capital stock of the Transitory Subsidiary:
(a) Capital Stock of the Transitory
Subsidiary. Each share of the common stock of the
Transitory Subsidiary issued and outstanding immediately prior
to the Effective Time shall be converted into and become one
fully paid and nonassessable share of common stock,
$0.001 par value per share, of the Surviving Corporation.
(b) Cancellation of Treasury Stock and
Public Company Owned Stock. All shares of Merger
Partner Common Stock that are owned by Merger Partner as
treasury stock or by any wholly owned Subsidiary of Merger
Partner and any shares of Merger Partner Common Stock owned by
Public Company, the Transitory Subsidiary or any other wholly
owned Subsidiary of Public Company immediately prior to the
Effective Time shall be cancelled and shall cease to exist and
no stock of Public Company or other consideration shall be
delivered in exchange therefor.
A-10
(c) Exchange Ratio for Merger Partner
Common Stock. Upon surrender of the certificate
representing such share of Merger Partner Common Stock in the
manner provided in Section 2.3 and subject to the
provisions thereof, each share of Merger Partner Common Stock
(other than shares to be cancelled in accordance with
Section 2.2(b) and Dissenting Shares) shall be converted
into and exchanged for the right to receive a number of shares
of Public Company Common Stock equal to the product of
(i) 2.3333 multiplied by (ii) the quotient of (A)
43,479,198 divided by (B) the sum of (x) the number of
shares of Merger Partner Common Stock outstanding immediately
prior to the Effective Time plus (y) the number of shares
of Merger Partner Common Stock issuable upon exercise of Merger
Partner Stock Options and Merger Partner Warrants outstanding
immediately prior to the Effective Time, subject to adjustment
as provided in Section 2.1(d) (the Exchange
Ratio). As of the Effective Time, all such shares of
Merger Partner Common Stock shall no longer be outstanding and
shall automatically be cancelled and shall cease to exist, and
each holder of a certificate representing any such shares of
Merger Partner Common Stock shall cease to have any rights with
respect thereto, except the right to receive the shares of
Public Company Common Stock pursuant to this Section 2.2(c)
and any cash in lieu of fractional shares of Public Company
Common Stock to be issued or paid in consideration therefor upon
the surrender of such certificate in accordance with
Section 2.3, without interest. For purposes of this
Agreement, Dissenting Shares shall mean
Merger Partner Common Stock held as of the Effective Time that
has not been voted in favor of the adoption of this Agreement
and with respect to which appraisal shall have been duly
demanded and perfected in accordance with the DGCL and not
effectively withdrawn or forfeited prior to the Effective Time.
(d) Unvested Stock. At
the Effective Time, any shares of Public Company Common Stock
issued in accordance with Section 2.2(c) with respect to
any unvested shares of Merger Partner Common Stock awarded to
employees, directors or consultants pursuant to any of Merger
Partners plans or arrangements and outstanding immediately
prior to the Effective Time shall remain subject to the same
terms, restrictions and vesting schedule as in effect
immediately prior to the Effective Time, except to the extent by
their terms such unvested shares of Merger Partner Common Stock
vest at the Effective Time. Copies of the relevant agreements
governing such shares and the vesting thereof have been provided
or made available to Public Company. All outstanding rights that
Merger Partner may hold immediately prior to the Effective Time
to repurchase unvested shares of Merger Partner Common Stock
shall be assigned to Public Company in the Merger and shall
thereafter be exercisable by Public Company upon the same terms
and conditions in effect immediately prior to the Effective
Time, except that the shares purchasable pursuant to such rights
and the purchase price payable per share shall be appropriately
adjusted to reflect the Exchange Ratio. Merger Partner shall
take all steps necessary to cause the foregoing provisions of
this Section 2.2(d) to occur.
2.3 Exchange of
Certificates. The procedures for exchanging
outstanding shares of Merger Partner Common Stock for Public
Company Common Stock pursuant to the Merger are as follows:
(a) Exchange Agent. As
of the Effective Time, Public Company shall deposit with BNY
Mellon Shareowner Services or another bank or trust company
designated by Public Company and reasonably acceptable to Merger
Partner (the Exchange Agent), for the benefit
of the holders of shares of Merger Partner Common Stock, for
exchange in accordance with this Section 2.3, through the
Exchange Agent, (i) certificates representing the shares of
Public Company Common Stock (such shares of Public Company
Common Stock, together with any dividends or distributions with
respect thereto with a record date after the Effective Time,
being hereinafter referred to as the Exchange
Fund) issuable pursuant to Section 2.2 in
exchange for outstanding shares of Merger Partner Common Stock,
(ii) cash in an amount sufficient to make payments for
fractional shares required pursuant to Section 2.3(c) and
(iii) any dividends or distributions to which holders of
certificates that immediately prior to the Effective Time
represented outstanding shares of Merger Partner Common Stock
(the Certificates) whose shares were
converted pursuant to Section 2.2 into the right to receive
shares of Public Company Common Stock may be entitled pursuant
to Section 2.3(d).
(b) Exchange
Procedures. As soon as reasonably practicable
after the Effective Time, the Exchange Agent shall mail to each
holder of record of a Certificate (i) a letter of
transmittal in customary form (which shall specify that delivery
shall be effected, and risk of loss and title to the
Certificates shall pass, only upon delivery of the Certificates
to the Exchange Agent) and (ii) instructions for effecting
the surrender of the Certificates in exchange for certificates
representing shares of Public Company Common Stock (plus
A-11
cash in lieu of fractional shares, if any, of Public Company
Common Stock and any dividends or distributions as provided
below). Upon surrender of a Certificate for cancellation to the
Exchange Agent or to such other agent or agents as may be
appointed by Public Company, together with such letter of
transmittal, duly executed, and such other documents as may
reasonably be required by the Exchange Agent, the holder of such
Certificate shall be entitled to receive in exchange therefor a
certificate representing that number of whole shares of Public
Company Common Stock which such holder has the right to receive
pursuant to the provisions of this Article II plus cash in
lieu of fractional shares pursuant to Section 2.3(c) and
any dividends or distributions then payable pursuant to
Section 2.3(d), and the Certificate so surrendered shall
immediately be cancelled. In the event of a transfer of
ownership of Merger Partner Common Stock which is not registered
in the transfer records of Merger Partner, a certificate
representing the proper number of shares of Public Company
Common Stock plus cash in lieu of fractional shares pursuant to
Section 2.3(c) and any dividends or distributions pursuant
to Section 2.3(d) may be issued or paid to a person other
than the person in whose name the Certificate so surrendered is
registered, if such Certificate is presented to the Exchange
Agent, accompanied by all documents required to evidence and
effect such transfer and by evidence that any applicable stock
transfer taxes have been paid. Until surrendered as contemplated
by this Section 2.3, each Certificate shall be deemed at
any time after the Effective Time to represent only the right to
receive upon such surrender the certificate representing shares
of Public Company Common Stock plus cash in lieu of fractional
shares pursuant to Section 2.3(c) and any dividends or
distributions then payable pursuant to Section 2.3(d), as
contemplated by this Section 2.3.
(c) No Fractional
Shares. No certificate or scrip representing
fractional shares of Public Company Common Stock shall be issued
upon the surrender for exchange of Certificates, and such
fractional share interests shall not entitle the owner thereof
to vote or to any other rights of a stockholder of Public
Company. Notwithstanding any other provision of this Agreement,
each holder of shares of Merger Partner Common Stock converted
pursuant to the Merger who would otherwise have been entitled to
receive a fraction of a share of Public Company Common Stock
(after taking into account all Certificates delivered by such
holder and the aggregate number of shares of Merger Partner
Common Stock represented thereby) shall receive, in lieu
thereof, cash (without interest) in an amount equal to such
fractional part of a share of Public Company Common Stock
multiplied by the average of the last reported sales prices of
Public Company Common Stock at the 4:00 p.m., Eastern time,
end of regular trading hours on NASDAQ during the ten
consecutive trading days ending on the last trading day prior to
the Effective Time.
(d) Distributions with Respect to
Unexchanged Shares. No dividends or other
distributions declared or made after the Effective Time with
respect to Public Company Common Stock with a record date after
the Effective Time shall be paid to the holder of any
unsurrendered Certificate until such Certificate is surrendered
as described in Section 2.3(b), subject to
Section 2.3(i). Subject to the effect of applicable laws,
following surrender of any such Certificate, there shall be
issued and paid to the record holder of the Certificate, at the
time of such surrender the amount of dividends or other
distributions with a record date after the Effective Time
previously paid with respect to such whole shares of Public
Company Common Stock, without interest, and at the appropriate
payment date, the amount of dividends or other distributions
having a record date after the Effective Time but prior to
surrender and a payment date subsequent to surrender that are
payable with respect to such whole shares of Public Company
Common Stock.
(e) No Further Ownership Rights in
Merger Partner Common Stock. All shares of Public
Company Common Stock issued upon the surrender for exchange of
Certificates in accordance with the terms hereof (including any
cash or dividends or other distributions paid pursuant to
Section 2.3(c) or 2.3(d)) shall be deemed to have been
issued (and paid) in full satisfaction of all rights pertaining
to such shares of Merger Partner Common Stock, and from and
after the Effective Time there shall be no further registration
of transfers on the stock transfer books of the Surviving
Corporation of the shares of Merger Partner Common Stock that
were outstanding immediately prior to the Effective Time. If,
after the Effective Time, Certificates are presented to the
Surviving Corporation or the Exchange Agent for any reason, they
shall be cancelled and exchanged as provided in this
Article II, subject to applicable law in the case of
Dissenting Shares.
(f) Termination of Exchange
Fund. Any portion of the Exchange Fund that
remains undistributed to the holders of Merger Partner Common
Stock for 180 days after the Effective Time shall be
A-12
delivered to Public Company, upon demand, and any holder of
Merger Partner Common Stock who has not previously complied with
this Section 2.3 shall thereafter look only to Public
Company, as a general unsecured creditor, for payment of its
claim for Public Company Common Stock, any cash in lieu of
fractional shares of Public Company Common Stock and any
dividends or distributions with respect to Public Company Common
Stock.
(g) No Liability. To
the extent permitted by applicable law, none of Public Company,
the Transitory Subsidiary, Merger Partner, the Surviving
Corporation or the Exchange Agent shall be liable to any holder
of shares of Merger Partner Common Stock or Public Company
Common Stock, as the case may be, for such shares (or dividends
or distributions with respect thereto) delivered to a public
official pursuant to any applicable abandoned property, escheat
or similar law. If any Certificate shall not have been
surrendered immediately prior to such date on which any shares
of Public Company Common Stock, and any cash payable to the
holder of such Certificate or any dividends or distributions
payable to the holder of such Certificate pursuant to this
Article II would otherwise escheat to or become the
property of any Governmental Entity, any such shares of Public
Company Common Stock or cash, dividends or distributions in
respect of such Certificate shall, to the extent permitted by
applicable law, become the property of the Surviving
Corporation, free and clear of all claims or interest of any
person previously entitled thereto.
(h) Withholding
Rights. Each of Public Company, the Surviving
Corporation and the Exchange Agent shall be entitled to deduct
and withhold from the consideration otherwise payable pursuant
to this Agreement to any holder of shares of Merger Partner
Common Stock and any other recipient of payments hereunder such
amounts as it reasonably determines that it is required to
deduct and withhold with respect to the making of such payment
under the Code, or any other applicable provision of law. To the
extent that amounts are so withheld by the Surviving
Corporation, Public Company or the Exchange Agent, as the case
may be, such withheld amounts shall be treated for all purposes
of this Agreement as having been paid to the holder of the
shares of Merger Partner Common Stock or other recipient of
payments hereunder in respect of which such deduction and
withholding was made by the Surviving Corporation, Public
Company or the Exchange Agent, as the case may be.
(i) Lost
Certificates. If any Certificate shall have been
lost, stolen or destroyed, upon the making of an affidavit of
that fact by the person claiming such Certificate to be lost,
stolen or destroyed and, if required by the Surviving
Corporation, the posting by such person of a bond in such
reasonable amount as the Surviving Corporation may direct as
indemnity against any claim that may be made against it with
respect to such Certificate, the Exchange Agent shall issue in
exchange for such lost, stolen or destroyed Certificate the
shares of Public Company Common Stock and any cash in lieu of
fractional shares, and unpaid dividends and distributions on
shares of Public Company Common Stock deliverable in respect
thereof pursuant to this Agreement.
2.4 Merger Partner Stock Plans and
Merger Partner Warrants.
(a) At the Effective Time, each
outstanding option to purchase Merger Partner Common Stock
(Merger Partner Stock Options), whether
vested or unvested, and all stock option plans or other stock or
equity-related plans of Merger Partner (the Merger
Partner Stock Plans) themselves, insofar as they
relate to outstanding Merger Partner Stock Options, shall be
assumed by Public Company and shall become an option to acquire,
on the same terms and conditions as were applicable under such
Merger Partner Stock Option immediately prior to the Effective
Time, such number of shares of Public Company Common Stock as is
equal to the number of shares of Merger Partner Common Stock
subject to the unexercised portion of such Merger Partner Stock
Option immediately prior to the Effective Time multiplied by the
Exchange Ratio (rounded down to the nearest whole share number),
at an exercise price per share equal to the exercise price per
share of such Merger Partner Stock Option immediately prior to
the Effective Time divided by the Exchange Ratio (rounded up to
the nearest whole cent); provided that the assumption of
each Merger Partner Stock Option pursuant to this
Section 2.4(a) shall comply with all requirements of
Sections 424 and 409A of the Code and the final Treasury
regulations issued thereunder. Such Merger Partner Stock Options
shall continue in effect on the same terms and conditions to
which they are currently subject (subject to the adjustments
required by this Section 2.4 after giving effect to the
Merger).
A-13
(b) As soon as practicable after the
Effective Time, Public Company shall deliver to the participants
in the Merger Partner Stock Plans appropriate notice setting
forth such participants rights pursuant to the Merger
Partner Stock Options, as provided in this Section 2.4.
(c) Public Company shall take all
corporate action necessary to reserve for issuance a sufficient
number of shares of Public Company Common Stock for delivery
upon exercise of the Merger Partner Stock Options assumed in
accordance with this Section 2.4. As promptly as
practicable after the Effective Time, Public Company shall file
a registration statement on
Form S-8
(or any successor form) or another appropriate form with respect
to the shares of Public Company Common Stock subject to such
options and shall use commercially reasonable efforts to
maintain the effectiveness of such registration statement or
registration statements (and maintain the current status of the
prospectus or prospectuses contained therein) for so long as
such options remain outstanding.
(d) Merger Partner shall terminate any
employee stock purchase plans in accordance with their terms as
of or prior to the Effective Time.
(e) At the Effective Time, each Merger
Partner Warrant outstanding immediately prior to the Effective
Time shall be assumed by Public Company and shall become a
warrant to acquire, on the same terms and conditions as were
applicable under such Merger Partner Warrant, such number of
shares of Public Company Common Stock as is equal to the number
of shares of Merger Partner Common Stock subject to the
unexercised portion of such Merger Partner Warrant immediately
prior to the Effective Time multiplied by the Exchange Ratio
(rounded down to the nearest whole share number), at an exercise
price per share equal to the exercise price per share of such
Merger Partner Warrant immediately prior to the Effective Time
divided by the Exchange Ratio (rounded up to the nearest whole
cent) (each, as so adjusted, an Adjusted
Warrant). Prior to the Effective Time, Public Company
shall take all necessary actions for the assumption of Merger
Partner Warrants and their conversion into Adjusted Warrants,
including the reservation and listing of Public Company Common
Stock in a number at least equal to the number of shares of
Public Company Common Stock that will be subject to the Adjusted
Warrants.
2.5 Dissenting Shares.
(a) Dissenting Shares shall not be
converted into or represent the right to receive Public Company
Common Stock unless the stockholder holding such Dissenting
Shares shall have forfeited his, her or its right to appraisal
under the DGCL or properly withdrawn his, her or its demand for
appraisal. If such stockholder has so forfeited or withdrawn
his, her or its right to appraisal of Dissenting Shares, then
(i) as of the occurrence of such event, such holders
Dissenting Shares shall cease to be Dissenting Shares and shall
be converted into and represent the right to receive the Public
Company Common Stock issuable in respect of such Merger Partner
Common Stock pursuant to Section 2.2(c), and
(ii) promptly following the occurrence of such event,
Public Company shall deliver to the Exchange Agent a certificate
representing the Public Company Common Stock to which such
stockholder is entitled pursuant to Section 2.2(c).
(b) Merger Partner shall give Public
Company (i) prompt notice of any written demands for
appraisal of any Merger Partner Common Stock, withdrawals of
such demands and any other instruments that relate to such
demands received by Merger Partner and (ii) the opportunity
to direct all negotiations and proceedings with respect to
demands for appraisal under the DGCL. Merger Partner shall not,
except with the prior written consent of Public Company, make
any payment with respect to any demands for appraisal of Merger
Partner Common Stock or offer to settle or settle any such
demands.
ARTICLE III
REPRESENTATIONS
AND WARRANTIES OF MERGER PARTNER
Merger Partner represents and warrants to Public Company and the
Transitory Subsidiary that the statements contained in this
Article III are true and correct, except as expressly set
forth herein or in the disclosure schedule delivered by Merger
Partner to Public Company and the Transitory Subsidiary on the
date of this Agreement (the Merger Partner Disclosure
Schedule). The Merger Partner Disclosure Schedule
shall
A-14
be arranged in sections corresponding to the numbered and
lettered sections contained in this Article III and the
disclosure in any section shall qualify (1) the
corresponding section in this Article III and (2) the
other sections in this Article III only to the extent that
it is reasonably apparent from a reading of such disclosure that
it also qualifies or applies to such other sections. For
purposes hereof, to the knowledge of Merger Partner
and similar expressions mean the knowledge of the persons
identified on the Merger Partner Disclosure Schedule for this
purpose, as well as any other knowledge which such persons would
have possessed had they made reasonable inquiry with respect to
the matter in question.
3.1 Organization, Standing and
Power. Merger Partner is a corporation duly
organized, validly existing and in good standing under the laws
of the jurisdiction of its incorporation, has all requisite
corporate power and authority to own, lease and operate its
properties and assets and to carry on its business as currently
conducted and as currently proposed to be conducted, and is duly
qualified to do business and is in good standing as a foreign
corporation in each jurisdiction listed on Section 3.1 of
the Merger Partner Disclosure Schedule, which jurisdictions
constitute the only jurisdictions in which the character of the
properties it owns, operates or leases or the nature of its
activities makes such qualification necessary, except for such
failures to be so organized, qualified or in good standing,
individually or in the aggregate, that have not had, and are not
reasonably likely to have, a Merger Partner Material Adverse
Effect. For purposes of this Agreement, the term Merger
Partner Material Adverse Effect means any material
adverse change, event, circumstance or development with respect
to, or material adverse effect on, (i) the business,
assets, liabilities, condition (financial or other), or results
of operations of Merger Partner and its Subsidiaries, taken as a
whole, or (ii) the ability of Merger Partner and its
Subsidiaries to consummate the transactions contemplated by this
Agreement; provided, however, that the following
shall not be deemed to be a Merger Partner Material Adverse
Effect: any change or event caused by or resulting from
(A) changes in prevailing economic or market conditions in
the United States or any other jurisdiction in which such entity
has substantial business operations (except to the extent those
changes have a materially disproportionate effect on Merger
Partner and its Subsidiaries as compared to other similarly
situated participants in the industries or markets in which
Merger Partner and its Subsidiaries operate), (B) changes
or events, after the date hereof, affecting the industries in
which they operate generally (except to the extent those changes
or events have a materially disproportionate effect on Merger
Partner and its Subsidiaries as compared to other similarly
situated participants in the industries or markets in which
Merger Partner and its Subsidiaries operate), (C) changes,
after the date hereof, in generally accepted accounting
principles or requirements applicable to Merger Partner and its
Subsidiaries (except to the extent those changes have a
materially disproportionate effect on Merger Partner and its
Subsidiaries as compared to other similarly situated
participants in the industries or markets in which Merger
Partner and its Subsidiaries operate), (D) changes, after
the date hereof, in laws, rules or regulations of general
applicability or interpretations thereof by any Governmental
Entity (except to the extent those changes have a materially
disproportionate effect on Merger Partner and its Subsidiaries
as compared to other similarly situated participants in the
industries or markets in which Merger Partner and its
Subsidiaries operate), (E) the execution, delivery and
performance of this Agreement or the consummation of the
transactions contemplated hereby or thereby or the announcement
thereof, or (F) any outbreak of major hostilities in which
the United States is involved or any act of terrorism within the
United States or directed against its facilities or citizens
wherever located. For the avoidance of doubt, the parties agree
that the terms material, materially and
materiality as used in this Agreement with an
initial lower case m shall have their respective
customary and ordinary meanings, without regard to the meanings
ascribed to Merger Partner Material Adverse Effect in the prior
sentence of this paragraph or Public Company Material Adverse
Effect in Section 4.1. Merger Partner has provided or made
available to Public Company complete and accurate copies of its
Certificate of Incorporation and Bylaws and is not in default
under or in violation of any provision of either such document.
3.2 Capitalization.
(a) The authorized capital stock of
Merger Partner consists of 50,000,000 shares of Merger
Partner Common Stock. The rights and privileges of each class of
Merger Partners capital stock are as set forth in Merger
Partners Certificate of Incorporation. As of the close of
business on the business day prior to the date of this
Agreement, (i) 24,926,150 shares of Merger Partner
Common Stock were issued and
A-15
outstanding and (ii) no shares of Merger Partner Common
Stock were held in the treasury of Merger Partner or by
Subsidiaries of Merger Partner.
(b) Section 3.2(b) of the Merger
Partner Disclosure Schedule sets forth a complete and accurate
list, as of the close of business on the business day prior to
the date of this Agreement, of the holders of Merger Partner
Common Stock, showing the number of shares held by each
stockholder. Section 3.2(b) of the Merger Partner
Disclosure Schedule also sets forth a complete and accurate list
of all issued and outstanding shares of Merger Partner Common
Stock that constitute restricted stock or that are otherwise
subject to a repurchase or redemption right or right of first
refusal in favor of Merger Partner, indicating the name of the
applicable stockholder, the vesting schedule for any such
shares, including the extent to which any such repurchase or
redemption right or right of first refusal has lapsed as of the
date of this Agreement, whether (and to what extent) the vesting
will be accelerated in any way by the transactions contemplated
by this Agreement or by termination of employment or change in
position following consummation of the Merger, and whether such
holder has the sole power to vote and dispose of such shares.
(c) Section 3.2(c) of the Merger
Partner Disclosure Schedule sets forth a complete and accurate
list, as of the date of this Agreement, of: (i) all Merger
Partner Stock Plans, indicating for each Merger Partner Stock
Plan, as of the close of business on the business day prior to
the date of this Agreement, the number of shares of Merger
Partner Common Stock issued to date under such Plan, the number
of shares of Merger Partner Common Stock subject to outstanding
options under such Plan and the number of shares of Merger
Partner Common Stock reserved for future issuance under such
Plan; and (ii) all outstanding Merger Partner Stock
Options, indicating with respect to each such Merger Partner
Stock Option the name of the holder thereof, the Merger Partner
Stock Plan under which it was granted, the number of shares of
Merger Partner Common Stock subject to such Merger Partner Stock
Option, the exercise price, the date of grant and the vesting
schedule, including whether (and to what extent) the vesting
will be accelerated in any way by the transactions contemplated
by this Agreement or by termination of employment or change in
position following consummation of the Merger. Merger Partner
has provided or made available to Public Company complete and
accurate copies of all Merger Partner Stock Plans and the forms
of all stock option agreements evidencing Merger Partner Stock
Options.
(d) Section 3.2(d) of the Merger
Partner Disclosure Schedule sets forth the number of shares of
Merger Partner Common Stock reserved for future issuance
pursuant to warrants or other outstanding rights (other than
Merger Partner Stock Options) to purchase shares of Merger
Partner Common Stock outstanding as of the date of this
Agreement (such outstanding warrants or other rights, the
Merger Partner Warrants) and the agreement or
other document under which such Merger Partner Warrants were
granted and sets forth a complete and accurate list of all
holders of Merger Partner Warrants indicating the number and
type of shares of Merger Partner Common Stock subject to each
Merger Partner Warrant, and the exercise price, the date of
grant and the expiration date thereof. Merger Partner has
provided or made available to Public Company complete and
accurate copies of the forms of agreements evidencing all Merger
Partner Warrants.
(e) Except (i) as set forth in this
Section 3.2 and (ii) as reserved for future grants
under Merger Partner Stock Plans, (A) there are no equity
securities of any class of Merger Partner, or any security
exchangeable into or exercisable for such equity securities,
issued, reserved for issuance or outstanding and (B) there
are no options, warrants, equity securities, calls, rights,
commitments or agreements of any character to which Merger
Partner or any of its Subsidiaries is a party or by which Merger
Partner or any of its Subsidiaries is bound obligating Merger
Partner or any of its Subsidiaries to issue, exchange, transfer,
deliver or sell, or cause to be issued, exchanged, transferred,
delivered or sold, additional shares of capital stock or other
equity interests of Merger Partner or any security or rights
convertible into or exchangeable or exercisable for any such
shares or other equity interests, or obligating Merger Partner
or any of its Subsidiaries to grant, extend, accelerate the
vesting of, otherwise modify or amend or enter into any such
option, warrant, equity security, call, right, commitment or
agreement. Merger Partner does not have any outstanding stock
appreciation rights, phantom stock, performance based rights or
similar rights or obligations. Other than the Merger Partner
Stockholder Agreements and the Merger Partner Noteholder
Agreement, neither Merger Partner nor any of its Affiliates is a
party to or is bound by any, and to the knowledge of Merger
Partner, there
A-16
are no, agreements or understandings with respect to the voting
(including voting trusts and proxies) or sale or transfer
(including agreements imposing transfer restrictions) of any
shares of capital stock or other equity interests of Merger
Partner. For purposes of this Agreement, the term
Affiliate when used with respect to any party
shall mean any person who is an affiliate of that
party within the meaning of Rule 405 promulgated under the
Securities Act of 1933, as amended (the Securities
Act). Except as contemplated by this Agreement or
described in this Section 3.2(e), there are no registration
rights, and there is no rights agreement, poison
pill anti-takeover plan or other agreement or
understanding to which Merger Partner or any of its Subsidiaries
is a party or by which it or they are bound with respect to any
equity security of any class of Merger Partner.
(f) All outstanding shares of Merger
Partner Common Stock are, and all shares of Merger Partner
Common Stock subject to issuance as specified in
Sections 3.2(c) and 3.2(d), upon issuance on the terms and
conditions specified in the instruments pursuant to which they
are issuable, will be, duly authorized, validly issued, fully
paid and nonassessable and not subject to or issued in violation
of any purchase option, call option, right of first refusal,
preemptive right, subscription right or any similar right under
any provision of the DGCL, Merger Partners Certificate of
Incorporation or Bylaws or any agreement to which Merger Partner
is a party or is otherwise bound. There are no obligations,
contingent or otherwise, of Merger Partner or any of its
Subsidiaries to repurchase, redeem or otherwise acquire any
shares of Merger Partner Common Stock. All outstanding shares of
Merger Partner Common Stock have been offered, issued and sold
by Merger Partner in compliance with all applicable federal and
state securities laws.
(g) No consent of the holders of Merger
Partner Stock Options or Merger Partner Warrants is required in
connection with the actions contemplated by Section 2.4.
3.3 Subsidiaries.
(a) Section 3.3(a) of the Merger
Partner Disclosure Schedule sets forth, for each Subsidiary of
Merger Partner: (i) its name; (ii) the number and type
of outstanding equity securities and a list of the holders
thereof; and (iii) the jurisdiction of organization. For
purposes of this Agreement, the term
Subsidiary means, with respect to any party,
any corporation, partnership, trust, limited liability company
or other non-corporate business enterprise in which such party
(or another Subsidiary of such party) holds stock or other
ownership interests representing (A) more that 50% of the
voting power of all outstanding stock or ownership interests of
such entity or (B) the right to receive more than 50% of
the net assets of such entity available for distribution to the
holders of outstanding stock or ownership interests upon a
liquidation or dissolution of such entity.
(b) Each Subsidiary of Merger Partner is
a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction of its
incorporation, has all requisite corporate power and authority
to own, lease and operate its properties and assets and to carry
on its business as currently conducted and as currently proposed
to be conducted, and is duly qualified to do business and is in
good standing as a foreign corporation in each jurisdiction
where the character of its properties owned, operated or leased
or the nature of its activities makes such qualification
necessary, except for such failures to be so organized,
qualified or in good standing, individually or in the aggregate,
that have not had, and are not reasonably likely to have, a
Merger Partner Material Adverse Effect. All of the outstanding
shares of capital stock and other equity securities or interests
of each Subsidiary of Merger Partner are duly authorized,
validly issued, fully paid, nonassessable and free of preemptive
rights and all such shares are owned, of record and
beneficially, by Merger Partner or another of its Subsidiaries
free and clear of all security interests, liens, claims,
pledges, agreements, limitations in Merger Partners voting
rights, charges or other encumbrances of any nature. There are
no outstanding or authorized options, warrants, rights,
agreements or commitments to which Merger Partner or any of its
Subsidiaries is a party or which are binding on any of them
providing for the issuance, disposition or acquisition of any
capital stock of any Subsidiary of Merger Partner. There are no
outstanding stock appreciation, phantom stock or similar rights
with respect to any Subsidiary of Merger Partner. There are no
voting trusts, proxies or other agreements or understandings
with respect to the voting of any capital stock of any
Subsidiary of Merger Partner.
A-17
(c) Merger Partner has provided or made
available to Public Company complete and accurate copies of the
charter, bylaws or other organizational documents of each
Subsidiary of Merger Partner.
(d) Merger Partner does not control
directly or indirectly or have any direct or indirect equity
participation or similar interest in any corporation,
partnership, limited liability company, joint venture, trust or
other business association or entity which is not a Subsidiary
of Merger Partner. There are no obligations, contingent or
otherwise, of Merger Partner or any of its Subsidiaries to
repurchase, redeem or otherwise acquire any shares of capital
stock of any Subsidiary of Merger Partner or to provide funds to
or make any material investment (in the form of a loan, capital
contribution or otherwise) in any Subsidiary of Merger Partner
or any other entity, other than guarantees of bank obligations
of Subsidiaries of Merger Partner entered into in the ordinary
course of business consistent with past practice (the
Ordinary Course of Business).
3.4 Authority; No Conflict; Required
Filings and Consents.
(a) Merger Partner has all requisite
corporate power and authority to enter into this Agreement,
subject only to the adoption of this Agreement (the
Merger Partner Voting Proposal) by Merger
Partners stockholders under the DGCL (the Merger
Partner Stockholder Approval), to consummate the
transactions contemplated by this Agreement. Without limiting
the generality of the foregoing, the Merger Partner Board, at a
meeting duly called and held, by the unanimous vote of all
directors, or by unanimous written consent in lieu of a meeting,
(i) determined that the Merger is advisable, fair and in
the best interests of Merger Partner and its stockholders,
(ii) approved this Agreement and declared its advisability
in accordance with the provisions of the DGCL,
(iii) directed that this Agreement be submitted to the
stockholders of Merger Partner for their adoption and resolved
to recommend that the stockholders of Merger Partner vote in
favor of the adoption of this Agreement and (iv) to the
extent necessary, adopted a resolution having the effect of
causing Merger Partner not to be subject to any state takeover
law or similar law that might otherwise apply to the Merger and
any other transactions contemplated by this Agreement. The
execution and delivery of this Agreement and the consummation of
the transactions contemplated by this Agreement by Merger
Partner have been duly authorized by all necessary corporate
action on the part of Merger Partner, subject only to the
required receipt of the Merger Partner Stockholder Approval.
This Agreement has been duly executed and delivered by Merger
Partner and constitutes the valid and binding obligation of
Merger Partner, enforceable in accordance with its terms,
subject to bankruptcy, insolvency, fraudulent transfer,
reorganization, moratorium and similar laws of general
applicability relating to or affecting creditors rights
and to general equity principles (the Bankruptcy and
Equity Exception).
(b) The execution and delivery of this
Agreement by Merger Partner do not, and the consummation by
Merger Partner of the transactions contemplated by this
Agreement shall not, (i) conflict with, or result in any
violation or breach of, any provision of the Certificate of
Incorporation or Bylaws of Merger Partner or of the charter,
bylaws or other organizational document of any Subsidiary of
Merger Partner, (ii) conflict with, or result in any
violation or breach of, or constitute (with or without notice or
lapse of time, or both) a default (or give rise to a right of
termination, cancellation or acceleration of any obligation or
loss of any material benefit) under, or require a consent or
waiver under, constitute a change in control under, require the
payment of a penalty under or result in the imposition of any
mortgage, security interest, pledge, lien, charge or encumbrance
of any nature (each, a Lien) on Merger
Partners or any of its Subsidiaries assets under any
of the terms, conditions or provisions of any note, bond,
mortgage, indenture, lease, license, contract or other
agreement, instrument or obligation to which Merger Partner or
any of its Subsidiaries is a party or by which any of them or
any of their properties or assets may be bound, or
(iii) subject to obtaining the Merger Partner Stockholder
Approval and compliance with the requirements specified in
clauses (i) through (iv) of Section 3.4(c),
conflict with or violate any permit, concession, franchise,
license, judgment, injunction, order, decree, statute, law,
ordinance, rule or regulation applicable to Merger Partner or
any of its Subsidiaries or any of its or their properties or
assets, except in the case of clauses (ii) and
(iii) of this Section 3.4(b) for any such conflicts,
violations, breaches, defaults, terminations, cancellations,
accelerations or losses that, individually or in the aggregate,
have not had, and are not reasonably likely to have, a Merger
Partner Material Adverse Effect. Section 3.4(b) of the
Merger Partner Disclosure Schedule lists all consents, waivers
and approvals under any of Merger Partners or any of its
A-18
Subsidiaries agreements, licenses or leases required to be
obtained in connection with the consummation of the transactions
contemplated by this Agreement, which, if individually or in the
aggregate were not obtained, would result in a material loss of
benefits to Merger Partner, Public Company or the Surviving
Corporation as a result of the Merger.
(c) No consent, approval, license,
permit, order or authorization of, or registration, declaration,
notice or filing with, any court, arbitrational tribunal,
administrative agency or commission or other governmental or
regulatory authority, agency or instrumentality (a
Governmental Entity) is required by or with
respect to Merger Partner or any of its Subsidiaries in
connection with the execution and delivery of this Agreement by
Merger Partner or the consummation by Merger Partner of the
transactions contemplated by this Agreement, except for
(i) the filing of the Certificate of Merger with the
Delaware Secretary of State and appropriate corresponding
documents with the appropriate authorities of other states in
which Merger Partner is qualified as a foreign corporation to
transact business, (ii) the filing of the Proxy
Statement/Prospectus with the U.S. Securities and Exchange
Commission (the SEC) in accordance with the
Securities Exchange Act of 1934, as amended (the
Exchange Act), (iii) such consents,
approvals, orders, authorizations, registrations, declarations
and filings as may be required under applicable state securities
laws and (iv) such other consents, authorizations, orders,
filings, approvals and registrations that, individually or in
the aggregate, if not obtained or made, would not be reasonably
likely to have a Merger Partner Material Adverse Effect.
(d) The affirmative vote in favor of the
Merger Partner Voting Proposal by the holders of a majority of
the votes represented by the outstanding shares of Merger
Partner Common Stock, which is to be delivered pursuant to
written consents of stockholders in lieu of a meeting
(collectively, the Written Consents), is the
only vote of the holders of any class or series of Merger
Partners capital stock or other securities necessary to
adopt this Agreement and for consummation by Merger Partner of
the other transactions contemplated by this Agreement. There are
no bonds, debentures, notes or other indebtedness of Merger
Partner having the right to vote (or convertible into, or
exchangeable for, securities having the right to vote) on any
matters on which stockholders of Merger Partner may vote.
3.5 Merger Partner Financial
Statements; Information Provided.
(a) Merger Partner has provided to Public
Company the Merger Partner Financial Statements prior to the
date of this Agreement. The Merger Partner Financial Statements
(i) comply as to form in all material respects with
applicable accounting requirements, (ii) were prepared in
accordance with United States generally accepted accounting
principles (GAAP) applied on a consistent
basis throughout the periods covered thereby (except as may be
indicated in the notes to such financial statements) and
(iii) fairly present the consolidated financial position of
Merger Partner and its Subsidiaries as of the dates thereof and
the consolidated results of its operations and cash flows for
the periods indicated, consistent with the books and records of
Merger Partner and its Subsidiaries, except that the unaudited
interim financial statements are subject to normal and recurring
year-end adjustments which will not be material in amount or
effect and do not include footnotes. For purposes of this
Agreement, Merger Partner Financial
Statements means the audited consolidated balance
sheets and statements of income, changes in stockholders
equity and cash flows of Merger Partner as of the end of and for
each of the last three fiscal years, including the audited
consolidated balance sheet of Merger Partner (the
Merger Partner Balance Sheet) as of
December 31, 2007 (the Merger Partner Balance
Sheet Date).
(b) Merger Partner shall engage as
promptly as practicable, but in any event within 15 business
days, following the date of this Agreement an independent
registered public accounting firm to be mutually agreed upon by
Merger Partner and Public Company (the New Merger
Partner Audit Firm) to perform a new audit of the
consolidated balance sheets and statements of income, changes in
stockholders equity and cash flows of Merger Partner as of
the end of and for each of the last three fiscal years and a
review in accordance with Statement on Auditing Standards
No. 100 of the unaudited consolidated balance sheets and
statements of income and cash flows as of and for any applicable
interim period required to be included in or filed as an exhibit
or attached to the Registration Statement or the Proxy
Statement/Prospectus. The New Merger Partner Audit Firm shall be
at all times following its engagement by Merger Partner
(i) independent with respect to Merger Partner
within the meaning of
Regulation S-X
and (ii) in compliance
A-19
with subsections (g) through (l) of Section 10A
of the Exchange Act (to the extent applicable) and the related
rules of the SEC and the Public Company Accounting Oversight
Board. Notwithstanding anything to the contrary in this
Section 3.5(b), the audit committee (or equivalent body) of
Merger Partner need not be comprised of members who are
independent within the meaning of Section 10A
of the Exchange Act and
Rule 10A-3
promulgated thereunder.
(c) The information to be supplied by or
on behalf of Merger Partner for inclusion or incorporation by
reference in the registration statement on
Form S-4
to be filed by Public Company pursuant to which shares of Public
Company Common Stock issued in connection with the Merger shall
be registered under the Securities Act (the
Registration Statement), or to be included or
supplied by or on behalf of Merger Partner for inclusion in any
filing pursuant to Rule 165 and Rule 425 under the
Securities Act or
Rule 14a-12
under the Exchange Act (each a
Regulation M-A
Filing), shall not at the time the Registration
Statement or any such
Regulation M-A
Filing is filed with the SEC, at any time it is amended or
supplemented or at the time the Registration Statement is
declared effective by the SEC, as applicable, contain any untrue
statement of a material fact or omit to state any material fact
required to be stated therein or necessary in order to make the
statements therein not misleading. The information to be
supplied by or on behalf of Merger Partner for inclusion in the
proxy statement/prospectus (the Proxy
Statement/Prospectus) to be sent to (i) the
stockholders of Public Company in connection with the meeting of
Public Companys stockholders (the Public Company
Meeting) to consider (A) the issuance of shares
of Public Company Common Stock in the Merger, (B) the
Reverse Stock Split and (C) changing the name of Public
Company to Cornerstone Therapeutics Inc. effective
immediately after the Effective Time (collectively, the
Public Company Voting Proposals) under NASDAQ
rules and the DGCL, as applicable (the Public Company
Stockholder Approval), and (ii) to the
stockholders of Merger Partner, which information shall be
deemed to include all information about or relating to Merger
Partner and its Subsidiaries and the statutory appraisal rights
of the stockholders of Merger Partner under Section 262 of
the DGCL (the Appraisal Rights), shall not,
on the date the Proxy Statement/Prospectus is first mailed to
stockholders of Public Company or Merger Partner, or at the time
of the Public Company Meeting or at the Effective Time, contain
any statement that, at such time and in light of the
circumstances under which it shall be made, is false or
misleading with respect to any material fact, or omit to state
any material fact necessary in order to make the statements made
in the Proxy Statement/Prospectus not false or misleading; or
omit to state any material fact necessary to correct any
statement in any earlier communication with respect to the
solicitation of proxies for the Public Company Meeting that has
become false or misleading. If at any time prior to the
Effective Time any fact or event relating to Merger Partner or
any of its Affiliates which should be set forth in an amendment
to the Registration Statement or a supplement to the Proxy
Statement/Prospectus should be discovered by Merger Partner or
should occur, Merger Partner shall promptly inform Public
Company of such fact or event.
3.6 No Undisclosed
Liabilities. Except as reflected or reserved
against on the Merger Partner Financial Statements (including
the notes thereto), and except for normal and recurring
liabilities incurred since the date of the Merger Partner
Balance Sheet in the Ordinary Course of Business, Merger Partner
and its Subsidiaries do not have any liabilities (whether known
or unknown, whether absolute or contingent, whether liquidated
or unliquidated, whether due or to become due, and whether or
not required to be reflected in financial statements (including
the notes thereto) in accordance with GAAP), that, individually
or in the aggregate, are reasonably likely to have a Merger
Partner Material Adverse Effect.
3.7 Absence of Certain Changes or
Events. Since the Merger Partner Balance Sheet
Date, Merger Partner and its Subsidiaries have conducted their
respective businesses only in the Ordinary Course of Business
and, since such date, there has not been (i) any change,
event, circumstance, development or effect that, individually or
in the aggregate, has had, or is reasonably likely to have, a
Merger Partner Material Adverse Effect; or (ii) any other
action or event that would have required the consent of Public
Company pursuant to Section 5.1 of this Agreement had such
action or event occurred after the date of this Agreement.
3.8 Taxes.
(a) Each of Merger Partner and its
Subsidiaries has properly filed on a timely basis all material
Tax Returns that it was required to file, and all such Tax
Returns were true, correct and complete in
A-20
all material respects. Each of Merger Partner and its
Subsidiaries has paid on a timely basis all Taxes that were due
and payable. The unpaid Taxes of Merger Partner and each of its
Subsidiaries for Tax periods through the date of the Merger
Partner Balance Sheet do not exceed the accruals and reserves
for Taxes (excluding accruals and reserves for deferred Taxes
established to reflect timing differences between book and Tax
income) set forth on the Merger Partner Balance Sheet and all
unpaid Taxes of Merger Partner and each of its Subsidiaries for
all Tax periods commencing after the date of the Merger Partner
Balance Sheet arose in the Ordinary Course of Business and are
of a type and amount commensurate with Taxes attributable to
prior similar periods. Neither Merger Partner nor any of its
Subsidiaries is or has ever been a member of a group of
corporations with which it has filed (or been required to file)
consolidated, combined or unitary Tax Returns, other than a
group of which the common parent is Merger Partner. Neither
Merger Partner nor any of its Subsidiaries (i) has any
liability under Treasury Regulations
Section 1.1502-6
(or any comparable or similar provision of federal, state, local
or foreign law), as a transferee or successor, pursuant to any
contractual obligation, or otherwise for any Taxes of any person
other than Merger Partner or any of its Subsidiaries, or
(ii) is a party to or bound by any Tax indemnity, Tax
sharing, Tax allocation or similar agreement. All material Taxes
that Merger Partner or any of its Subsidiaries was required by
law to withhold or collect have been duly withheld or collected
and, to the extent required, have been properly paid to the
appropriate Governmental Entity. For purposes of this Agreement,
(i) Taxes shall mean any and all taxes,
charges, fees, duties, contributions, levies or other similar
assessments or liabilities in the nature of a tax, including,
without limitation, income, gross receipts, corporation, ad
valorem, premium, value-added, net worth, capital stock, capital
gains, documentary, recapture, alternative or add-on minimum,
disability, estimated, registration, recording, excise, real
property, personal property, sales, use, license, lease,
service, service use, transfer, withholding, employment,
unemployment, insurance, social security, national insurance,
business license, business organization, environmental, workers
compensation, payroll, profits, severance, stamp, occupation,
windfall profits, customs duties, franchise and other taxes of
any kind whatsoever imposed by the United States of America or
any state, local or foreign government, or any agency or
political subdivision thereof, and any interest, fines,
penalties, assessments or additions to tax imposed with respect
to such items or any contest or dispute thereof, and
(ii) Tax Returns shall mean any and all
reports, returns, declarations, or statements relating to Taxes
supplied to a Governmental Entity, including any schedule or
attachment thereto and any related or supporting work papers or
information with respect to any of the foregoing, including any
amendment thereof.
(b) Merger Partner has delivered or made
available to Public Company (i) complete and correct copies
of all Tax Returns of Merger Partner and any of its Subsidiaries
relating to Taxes for all taxable periods for which the
applicable statute of limitations has not yet expired, and
(ii) complete and correct copies of all private letter
rulings, revenue agent reports, information document requests,
notices of proposed deficiencies, deficiency notices, protests,
petitions, closing agreements, settlement agreements, pending
ruling requests and any similar documents submitted by, received
by, or agreed to by or on behalf of Merger Partner or any of its
Subsidiaries relating to Taxes for all taxable periods for which
the statute of limitations has not yet expired. The federal
income Tax Returns of Merger Partner and each of its
Subsidiaries have been audited by the Internal Revenue Service
(the IRS) or are closed by the
applicable statute of limitations for all taxable years through
the taxable year specified in Section 3.8(b) of the Merger
Partner Disclosure Schedule. No examination or audit of any Tax
Return of Merger Partner or any of its Subsidiaries by any
Governmental Entity is currently in progress or, to the
knowledge of Merger Partner, threatened or contemplated. Neither
Merger Partner nor any of its Subsidiaries has been informed by
any jurisdiction that the jurisdiction believes that Merger
Partner or any of its Subsidiaries was required to file any Tax
Return that was not filed. Neither Merger Partner nor any of its
Subsidiaries has (i) waived any statute of limitations with
respect to Taxes or agreed to extend the period for assessment
or collection of any Taxes, (ii) requested any extension of
time within which to file any Tax Return, which Tax Return has
not yet been filed, or (iii) executed or filed any power of
attorney with any taxing authority.
(c) Neither Merger Partner nor any of its
Subsidiaries has made any payment, is obligated to make any
payment, or is a party to any agreement that could obligate it
to make any payment that may be treated as an excess
parachute payment under Section 280G of the Code
(without regard to Sections 280G(b)(4) and 280G(b)(5) of
the Code).
A-21
(d) There are no adjustments under
Section 481 of the Code (or any similar adjustments under
any provision of the Code or the corresponding foreign, state or
local Tax laws) that are required to be taken into account by
Merger Partner or any of its Subsidiaries in any period ending
after the Closing Date by reason of a change in method of
accounting in any taxable period ending on or before the Closing
Date or as a result of the consummation of the transactions
contemplated by this Agreement.
(e) Neither Merger Partner nor any of its
Subsidiaries has been a United States real property holding
corporation within the meaning of Section 897(c)(2) of the
Code during the applicable period specified in
Section 897(c)(l)(A)(ii) of the Code.
(f) Neither Merger Partner nor any of its
Subsidiaries has distributed to its stockholders or security
holders stock or securities of a controlled corporation, nor has
stock or securities of Merger Partner or any of its Subsidiaries
been distributed, in a transaction to which Section 355 of
the Code applies (i) in the two years prior to the date of
this Agreement or (ii) in a distribution that could
otherwise constitute part of a plan or series
of related transactions (within the meaning of
Section 355(e) of the Code) that includes the transactions
contemplated by this Agreement.
(g) There are no liens or other
encumbrances with respect to Taxes upon any of the assets or
properties of Merger Partner or any of its Subsidiaries, other
than with respect to Taxes not yet due and payable or being
contested in good faith by appropriate proceedings.
(h) Neither Merger Partner nor any of its
Subsidiaries will be required to include any item of income in,
or exclude any item of deduction from, taxable income for any
period (or any portion thereof) ending after the Closing Date as
a result of any (i) deferred intercompany gain or any
excess loss account described in Treasury Regulations under
Section 1502 of the Code (or any corresponding provision of
state, local or foreign Tax law), (ii) closing agreement as
described in Section 7121 of the Code (or any corresponding
or similar provision of state, local or foreign Tax law)
executed on or prior to the Closing Date, (iii) installment
sale or other open transaction disposition made on or prior to
the Closing Date, or (iv) prepaid amount received on or
prior to the Closing Date.
(i) Neither Merger Partner nor any of its
Subsidiaries has participated in any reportable
transaction as defined in
section 1.6011-4(b)
of the Treasury Regulations or any analogous provision of state
or local law.
3.9 Owned and Leased Real
Properties.
(a) Neither Merger Partner nor any of its
Subsidiaries owns or has ever owned any real property.
(b) Section 3.9(b) of the Merger
Partner Disclosure Schedule sets forth a complete and accurate
list of all real property leased, subleased or licensed by
Merger Partner or any of its Subsidiaries (collectively, the
Merger Partner Leases) and the location of
the premises. Neither Merger Partner, nor any of its
Subsidiaries nor, to the knowledge of Merger Partner, any other
party is in default under any of the Merger Partner Leases,
except where the existence of such defaults, individually or in
the aggregate, has not had, and is not reasonably likely to
have, a Merger Partner Material Adverse Effect. Neither Merger
Partner nor any of its Subsidiaries leases, subleases or
licenses any real property to any person other than Merger
Partner and its Subsidiaries. Merger Partner has provided or
made available to Public Company complete and accurate copies of
all Merger Partner Leases.
3.10 Intellectual Property.
(a) Merger Partner and its Subsidiaries
own, license or otherwise possess legally enforceable rights to
use all Intellectual Property used or necessary to conduct the
business of Merger Partner and its Subsidiaries as currently
conducted, or that would be used or necessary as such business
is currently proposed to be conducted (excluding
currently-available, off-the-shelf software programs that are
licensed by Merger Partner pursuant to shrink wrap
licenses under which aggregate fees and royalties paid to the
licensor do not exceed $50,000 annually), the absence of which,
individually or in the aggregate, is reasonably likely to have a
Merger Partner Material Adverse Effect.
A-22
(b) The execution and delivery of this
Agreement and consummation of the Merger will not result in the
breach of, or create on behalf of any third party the right to
terminate or modify, (i) any license, sublicense or other
agreement relating to any Intellectual Property owned by Merger
Partner or any of its Subsidiaries that is material to the
business of Merger Partner and its Subsidiaries, taken as a
whole, including software that is used in the development or
manufacture of or forms a part of any product or service sold by
or expected to be sold by Merger Partner or any of its
Subsidiaries (the Merger Partner Intellectual
Property) or (ii) any license, sublicense and
other agreement as to which Merger Partner or any of its
Subsidiaries is a party and pursuant to which Merger Partner or
any of its Subsidiaries is authorized to use any third party
Intellectual Property that is material to the business of Merger
Partner and its Subsidiaries, taken as a whole, including
software that is used in the development or manufacture of or
forms a part of any product or service sold by or expected to be
sold by Merger Partner or any of its Subsidiaries (the
Merger Partner Third Party Intellectual
Property). Section 3.10(b)(i) of the Merger
Partner Disclosure Schedule sets forth a complete and accurate
list of Merger Partner Intellectual Property (other than
unregistered copyrights, trade secrets and confidential
information) and Section 3.10(b)(ii) sets forth a complete
and accurate list of all Merger Partner Third Party Intellectual
Property.
(c) All patents and registrations and
applications for Trademarks, service marks and copyrights which
are held by Merger Partner or any of its Subsidiaries and that
are material to the business of Merger Partner and its
Subsidiaries, taken as a whole, are valid and subsisting. Merger
Partner and its Subsidiaries have taken reasonable measures to
protect the proprietary nature of the Merger Partner
Intellectual Property. To the knowledge of Merger Partner, no
other person or entity is infringing, violating or
misappropriating any of the Merger Partner Intellectual Property
or Merger Partner Third Party Intellectual Property, except for
infringements, violations or misappropriations that,
individually or in the aggregate, are not reasonably likely to
have a Merger Partner Material Adverse Effect.
(d) To the knowledge of Merger Partner,
none of the (i) products previously or currently sold by
Merger Partner or any of its Subsidiaries or (ii) business
or activities previously or currently conducted by Merger
Partner or any of its Subsidiaries infringes, violates or
constitutes a misappropriation of, any Intellectual Property of
any third party, except for such infringements, violations and
misappropriations that, individually or in the aggregate, have
not had, and are not reasonably likely to have, a Merger Partner
Material Adverse Effect. Neither Merger Partner nor any of its
Subsidiaries has received any complaint, claim or notice
alleging any such infringement, violation or misappropriation.
(e) For purposes of this Agreement, the
following terms shall have the following meanings:
(i) Intellectual
Property means the following subsisting throughout the
world:
(A) Patent Rights;
(B) Trademarks and all goodwill in the
Trademarks;
(C) copyrights, designs, data and
database rights and registrations and applications for
registration thereof, including moral rights of authors;
(D) mask works and registrations and
applications for registration thereof under the laws of any
jurisdiction;
(E) inventions, invention disclosures,
statutory invention registrations, trade secrets and
confidential business information, know-how, manufacturing and
product processes and techniques, research and development
information, financial, marketing and business data, pricing and
cost information, business and marketing plans and customer and
supplier lists and information, whether patentable or
nonpatentable, whether copyrightable or non-copyrightable and
whether or not reduced to practice; and
(F) other proprietary rights relating to
any of the foregoing (including remedies against infringement
thereof and rights of protection of interest therein under the
laws of all jurisdictions).
A-23
(ii) Patent Rights
means all patents, patent applications, utility models, design
registrations and certificates of invention and other
governmental grants for the protection of inventions or
industrial designs (including all related continuations,
continuations-in-part,
divisionals, reissues and reexaminations).
(iii) Trademarks means
all registered trademarks and service marks, logos, Internet
domain names, corporate names and doing business designations
and all registrations and applications for registration of the
foregoing, common law trademarks and service marks and trade
dress.
3.11 Contracts.
(a) Section 3.11(a) of the Merger
Partner Disclosure Schedule lists the following agreements
(written or oral) to which Merger Partner or any of its
Subsidiaries is a party as of the date of this Agreement:
(i) any agreement (or group of related
agreements) for the lease of personal property from or to third
parties providing for lease payments in excess of $150,000 per
annum or having a remaining term longer than six months;
(ii) any agreement (or group of related
agreements) that is not terminable without cause by Merger
Partner with less than 120 days notice without penalty,
including the payment of any termination fee or refund of
amounts previously received, and that is for the purchase or
sale of products or for the furnishing or receipt of services
(A) which calls for performance over a period of more than
one year, (B) which involves an aggregate of more than
$150,000 or (C) in which Merger Partner or any of its
Subsidiaries has granted manufacturing rights, most
favored nation pricing provisions or marketing or
distribution rights relating to any products or territory or has
agreed to purchase a minimum quantity of goods or services or
has agreed to purchase goods or services exclusively from a
particular party;
(iii) any agreement concerning the
establishment or operation of a partnership, joint venture or
limited liability company;
(iv) any agreement (or group of related
agreements) under which it has created, incurred, assumed or
guaranteed (or may create, incur, assume or guarantee)
indebtedness (including capitalized lease obligations) involving
more than $150,000 or under which it has imposed (or may impose)
a Lien on any of its assets, tangible or intangible;
(v) any agreement for the disposition of
any significant portion of the assets or business of Merger
Partner or any of its Subsidiaries (other than sales of products
in the Ordinary Course of Business) or any agreement for the
acquisition of the assets or business of any other entity (other
than purchases of inventory or components in the Ordinary Course
of Business);
(vi) any employment or consulting
agreement;
(vii) any agreement involving any current
or former officer, director or stockholder of Merger Partner or
an Affiliate thereof;
(viii) any agreement under which the
consequences of a default or termination would reasonably be
likely to have a Merger Partner Material Adverse Effect;
(ix) any agreement which contains any
provisions requiring Merger Partner or any of its Subsidiaries
to indemnify any other party (excluding indemnities contained in
agreements for the purchase, sale or license of products entered
into in the Ordinary Course of Business);
(x) any agreement that could reasonably
be expected to have the effect of prohibiting or impairing the
conduct of the business of Merger Partner or any of its
Subsidiaries or Public Company or any of its Subsidiaries as
currently conducted and as currently proposed to be conducted;
(xi) any agreement under which Merger
Partner or any of its Subsidiaries is restricted from selling,
licensing or otherwise distributing any of its technology or
products, or providing
A-24
services to, customers or potential customers or any class of
customers, in any geographic area, during any period of time or
any segment of the market or line of business;
(xii) any agreement under which Merger
Partner or any of its Subsidiaries has licensed any material
Intellectual Property to or from any third party (excluding
currently-available, off-the-shelf software programs that are
licensed by Merger Partner or any of its Subsidiaries pursuant
to shrink wrap licenses under which aggregate fees
and royalties paid to the licensor do not exceed $50,000
annually);
(xiii) any agreement that would entitle
any third party to receive a license or any other right to
intellectual property of Public Company or any of Public
Companys Affiliates following the Closing; and
(xiv) any other agreement (or group of
related agreements) (A) involving more than $150,000 or
(B) not entered into in the Ordinary Course of Business.
(b) Merger Partner has provided or made
available to Public Company a complete and accurate copy of each
agreement listed in Section 3.10 or Section 3.11 of
the Merger Partner Disclosure Schedule. With respect to each
agreement so listed: (i) the agreement is legal, valid,
binding and enforceable and in full force and effect;
(ii) the agreement will continue to be legal, valid,
binding and enforceable and in full force and effect immediately
following the Closing in accordance with the terms thereof as in
effect immediately prior to the Closing; and (iii) neither
Merger Partner nor any of its Subsidiaries nor, to the knowledge
of Merger Partner, any other party, is in breach or violation
of, or default under, any such agreement, and no event has
occurred, is pending or, to the knowledge of Merger Partner, is
threatened, which, with or without notice or lapse of time, or
both, would constitute a breach, violation or default by Merger
Partner or any of its Subsidiaries or, to the knowledge of
Merger Partner, any other party under such agreement, except for
breaches, violations or defaults that, individually or in the
aggregate, have not had, and are not reasonably likely to have,
a Merger Partner Material Adverse Effect. Neither Merger Partner
nor any of its Subsidiaries has received any notice in writing
from any other party, and, to the knowledge of Merger Partner,
no party has threatened, to terminate, cancel, fail to renew or
otherwise materially modify any such agreements the loss of
which, individually or in the aggregate, is reasonably likely to
have a Merger Partner Material Adverse Effect.
3.12 Litigation. There is no
action, suit, proceeding, claim, arbitration or investigation
before any Governmental Entity or before any arbitrator that is
pending or, to the knowledge of Merger Partner, has been
threatened in writing against Merger Partner or any of its
Subsidiaries that (a) seeks either damages in excess of
$150,000 or equitable relief or (b) in any manner
challenges or seeks to prevent, enjoin, alter or delay the
transactions contemplated by this Agreement. There are no
material judgments, orders or decrees outstanding against Merger
Partner or any of its Subsidiaries.
3.13 Environmental Matters.
(a) Except for such matters that,
individually or in the aggregate, have not had, and are not
reasonably likely to have, a Merger Partner Material Adverse
Effect:
(i) Merger Partner and its Subsidiaries
have complied with all applicable Environmental Laws;
(ii) to the actual knowledge of Merger
Partner, and without independent investigation, the properties
currently owned, leased or operated by Merger Partner and its
Subsidiaries (including soils, groundwater, surface water,
buildings or other structures) are not contaminated with any
Hazardous Substances at levels or in a condition that would
violate applicable Environmental Laws;
(iii) to the actual knowledge of Merger
Partner, and without independent investigation, the properties
formerly owned, leased or operated by Merger Partner or any of
its Subsidiaries were not, during the period of ownership, use
or operation by Merger Partner or any of its Subsidiaries,
contaminated with Hazardous Substances at levels or in a
condition that would violate applicable Environmental Laws;
A-25
(iv) neither Merger Partner nor any of
its Subsidiaries are subject to liability for any Hazardous
Substance disposal or contamination on the property of any third
party;
(v) neither Merger Partner nor any of its
Subsidiaries have released any Hazardous Substance into the
environment;
(vi) neither Merger Partner nor any of
its Subsidiaries has received any notice, demand, letter, claim
or request for information alleging that Merger Partner or any
of its Subsidiaries may be in violation of, liable under or have
obligations under any Environmental Law;
(vii) neither Merger Partner nor any of
its Subsidiaries is subject to any orders, decrees, injunctions
or other arrangements with any Governmental Entity or is subject
to any indemnity or other agreement with any third party
relating to liability under any Environmental Law or relating to
Hazardous Substances; and
(viii) there are no circumstances or
conditions involving Merger Partner, any of its Subsidiaries or
any of their respective properties that could reasonably be
expected to result in any claims, liability, obligations,
investigations, costs or restrictions on the ownership, use or
transfer of any property of Merger Partner or any of its
Subsidiaries pursuant to any Environmental Law.
(b) For purposes of this Agreement, the
term Environmental Law means any law,
regulation, order, decree, permit, authorization, opinion,
common law or agency requirement of any jurisdiction relating
to: (i) the protection, investigation or restoration of the
environment, human health and safety or natural resources,
(ii) the handling, use, storage, treatment, presence,
disposal, release or threatened release of any Hazardous
Substance or (iii) noise, odor, wetlands, pollution,
contamination or any injury or threat of injury to persons or
property.
(c) For purposes of this Agreement, the
term Hazardous Substance means any substance
that is: (i) listed, classified, regulated or which falls
within the definition of a hazardous substance,
hazardous waste or hazardous material
pursuant to any Environmental Law; (ii) any petroleum
product or by-product, asbestos-containing material,
lead-containing paint or plumbing, polychlorinated biphenyls,
radioactive materials or radon; or (iii) any other
substance that is the subject of regulatory action by any
Governmental Entity pursuant to any Environmental Law.
3.14 Employee Benefit Plans.
(a) Section 3.14(a) of the Merger
Partner Disclosure Schedule sets forth a complete and accurate
list of all Employee Benefit Plans maintained, or contributed
to, by Merger Partner or any of its Subsidiaries or any of their
respective ERISA Affiliates (collectively, the Merger
Partner Employee Plans).
(b) With respect to each Merger Partner
Employee Plan, Merger Partner has provided or made available to
Public Company, a complete and accurate copy of (i) such
plan (or a written summary of any unwritten plan), (ii) the
most recent annual report (Form 5500) filed with the
IRS, (iii) each trust agreement, group annuity contract and
summary plan description, if any, relating to such Merger
Partner Employee Plan, (iv) the most recent financial
statements for each Merger Partner Employee Plan that is funded,
(v) all personnel, payroll and employment manuals and
policies, (vi) all employee handbooks and (vii) all
reports regarding the satisfaction of the nondiscrimination
requirements of Sections 410(b), 401(k) and 401(m) of the
Code.
(c) Each Merger Partner Employee Plan has
been administered in all material respects in accordance with
ERISA, the Code and all other applicable laws and the
regulations thereunder and in accordance with its terms and each
of Merger Partner and its Subsidiaries and their respective
ERISA Affiliates has in all material respects met its
obligations with respect to such Merger Partner Employee Plan
and has made all required contributions thereto (or reserved
such contributions on the Merger Partner Balance Sheet). Merger
Partner and its Subsidiaries and each of their respective ERISA
Affiliates and each Merger Partner Employee Plan are in
compliance in all material respects with the currently
applicable provisions of ERISA and the Code and the regulations
thereunder (including Section 4980B of the Code, Subtitle
K, Chapter 100 of the Code and Sections 601 through
608 and Section 701 et seq. of ERISA). All filings and
A-26
reports as to each Merger Partner Employee Plan required to have
been submitted to the IRS or to the United States Department of
Labor have been timely submitted. With respect to Merger Partner
Employee Plans, no event has occurred, and to the knowledge of
Merger Partner, there exists no condition or set of
circumstances in connection with which Merger Partner or any of
its Subsidiaries could be subject to any liability that is
reasonably likely, individually or in the aggregate, to have a
Merger Partner Material Adverse Effect under ERISA, the Code or
any other applicable law.
(d) With respect to Merger Partner
Employee Plans, there are no benefit obligations for which
contributions have not been made or properly accrued and there
are no benefit obligations that have not been accounted for by
reserves, or otherwise properly footnoted in accordance with
GAAP, on the financial statements of Merger Partner, which
obligations are reasonably likely, individually or in the
aggregate, to have a Merger Partner Material Adverse Effect. The
assets of each Merger Partner Employee Plan that is funded are
reported at their fair market value on the books and records of
such Merger Partner Employee Plan.
(e) All Merger Partner Employee Plans
that are intended to be qualified under Section 401(a) of
the Code have received determination letters from the IRS to the
effect that such Merger Partner Employee Plans are qualified and
the plans and trusts related thereto are exempt from federal
income taxes under Sections 401(a) and 501(a),
respectively, of the Code, no such determination letter has been
revoked and revocation has not been threatened, and no such
Employee Benefit Plan has been amended or operated since the
date of its most recent determination letter or application
therefor in any respect, and no act or omission has occurred,
that would adversely affect its qualification or materially
increase its cost. Each Merger Partner Employee Plan that is
required to satisfy Section 401(k)(3) or
Section 401(m)(2) of the Code has been tested for
compliance with, and satisfies the requirements of,
Section 401(k)(3) and Section 401(m)(2) of the Code,
as the case may be, for each plan year ending prior to the
Closing Date.
(f) Neither Merger Partner nor any of its
Subsidiaries nor any of their respective ERISA Affiliates has
(i) ever maintained a Merger Partner Employee Benefit Plan
that was ever subject to Section 412 of the Code or
Title IV of ERISA or (ii) ever been obligated to
contribute to a multiemployer plan (as defined in
Section 4001(a)(3) of ERISA). No Merger Partner Employee
Plan is funded by, associated with or related to a
voluntary employees beneficiary association
within the meaning of Section 501(c)(9) of the Code. No
Merger Partner Employee Plan holds securities issued by Merger
Partner or any of its Subsidiaries or any of their respective
ERISA Affiliates.
(g) Each Merger Partner Employee Plan is
amendable and terminable unilaterally by Merger Partner and any
of Merger Partners Subsidiaries that are a party thereto
or covered thereby at any time without liability to Merger
Partner or any of its Subsidiaries as a result thereof (other
than for benefits accrued through the date of termination or
amendment and reasonable administrative expenses related
thereto), and no Merger Partner Employee Plan, plan
documentation or agreement, summary plan description or other
written communication distributed generally to employees by its
terms prohibits Merger Partner or any of its Subsidiaries from
amending or terminating any such Merger Partner Employee Plan.
The investment vehicles used to fund Merger Partner
Employee Plans may be changed at any time without incurring a
sales charge, surrender fee or other similar expense.
(h) Neither Merger Partner nor any of its
Subsidiaries is a party to any oral or written
(i) agreement with any stockholders, director, executive
officer or other employee of Merger Partner or any of its
Subsidiaries (A) the benefits of which are contingent, or
the terms of which are materially altered, upon the occurrence
of a transaction involving Merger Partner or any of its
Subsidiaries of the nature of any of the transactions
contemplated by this Agreement, (B) providing any term of
employment or compensation guarantee or (C) providing
severance benefits or other benefits after the termination of
employment of such director, executive officer or employee;
(ii) agreement, plan or arrangement under which any person
may receive payments from Merger Partner or any of its
Subsidiaries that may be subject to the tax imposed by
Section 4999 of the Code or included in the determination
of such persons parachute payment under
Section 280G of the Code, without regard to
Section 280G(b)(4); or (iii) agreement or plan binding
Merger Partner or any of its Subsidiaries, including any stock
option plan, stock appreciation right plan, restricted stock
plan, stock purchase plan or severance benefit plan, any of the
benefits of which shall be increased, or
A-27
the vesting of the benefits of which shall be accelerated, by
the occurrence of any of the transactions contemplated by this
Agreement or the value of any of the benefits of which shall be
calculated on the basis of any of the transactions contemplated
by this Agreement.
(i) None of the Merger Partner Employee
Plans promises or provides retiree medical or other retiree
welfare benefits to any person, except as required by applicable
law.
(j) Each Merger Partner Employee Plan
that is a nonqualified deferred compensation plan
(as defined in Code Section 409A(d)(1)) has been operated
since January 1, 2005 in good faith reasonable compliance
with Code Section 409A and IRS Notice
2005-1. No
Merger Partner Employee Plan that is a nonqualified
deferred compensation plan has been materially modified
(as determined under Notice
2005-1)
after October 3, 2004. No event has occurred that would be
treated by Code Section 409A(b) as a transfer of property
for purposes of Code Section 83. No stock option or equity
unit option granted under any Merger Partner Employee Plan has
an exercise price that has been or may be less than the fair
market value of the underlying stock or equity units (as the
case may be) as of the date such option was granted or has any
feature for the deferral of compensation other than the deferral
of recognition of income until the later of exercise or
disposition of such option.
(k) Section 3.14(k) of the Merger
Partner Disclosure Schedule sets forth the policy of Merger
Partner and each of its Subsidiaries with respect to accrued
vacation, accrued sick time and earned time off and the amount
of such liabilities as of April 15, 2008.
(l) For purposes of this Agreement, the
following terms shall have the following meanings:
(i) Employee Benefit
Plan means any employee pension benefit
plan (as defined in Section 3(2) of ERISA), any
employee welfare benefit plan (as defined in
Section 3(1) of ERISA) and any other written or oral plan,
agreement or arrangement involving direct or indirect
compensation, including insurance coverage, severance benefits,
disability benefits, deferred compensation, bonuses, stock
options, stock purchase, phantom stock, stock appreciation or
other forms of incentive compensation or post-retirement
compensation and all unexpired severance agreements, written or
otherwise, for the benefit of, or relating to, any current or
former employee of the entity in question or any of its
Subsidiaries or ERISA Affiliates.
(ii) ERISA means the
Employee Retirement Income Security Act of 1974, as amended.
(iii) ERISA Affiliate
means any entity that is, or at any applicable time was, a
member of (A) a controlled group of corporations (as
defined in Section 414(b) of the Code), (B) a group of
trades or businesses under common control (as defined in
Section 414(c) of the Code), or (C) an affiliated
service group (as defined under Section 414(m) of the Code
or the regulations under Section 414(o) of the Code), any
of which includes or included the entity in question or any of
its Subsidiaries.
3.15 Compliance With Laws. Merger
Partner and each of its Subsidiaries has complied with, is not
in violation of, and has not received any notice alleging any
violation with respect to, any applicable provisions of any
statute, law or regulation with respect to the conduct of its
business, or the ownership or operation of its properties or
assets, except for failures to comply or violations that,
individually or in the aggregate, have not had, and are not
reasonably likely to have, a Merger Partner Material Adverse
Effect.
3.16 Permits and Regulatory Matters.
(a) Merger Partner and each of its
Subsidiaries have all permits, licenses, registrations,
authorizations and franchises from Governmental Entities
required to conduct their businesses as currently conducted or
as currently proposed to be conducted, including without
limitation all such permits, licenses, registrations,
authorizations and franchises required by the U.S. Food and
Drug Administration (the FDA) or any other
Governmental Entity exercising comparable authority (the
Merger Partner Authorizations), except for
such permits, licenses, registrations, authorizations and
franchises the lack of which, individually or in the aggregate,
has not had, and is not reasonably likely to have, a Merger
Partner Material Adverse Effect. Merger Partner and its
Subsidiaries are in compliance with the terms of the Merger
Partner Authorizations, except where the failure to so comply,
individually or in the aggregate, has not had, and is not
reasonably likely to
A-28
have, a Merger Partner Material Adverse Effect. No Merger
Partner Authorization shall cease to be effective as a result of
the consummation of the transactions contemplated by this
Agreement.
(b) All manufacturing, processing,
distribution, labeling, storage, testing, specifications,
sampling, sale or marketing of products performed by or on
behalf of Merger Partner or any of its Subsidiaries are in
compliance with all applicable laws, rules, regulations or
orders administered or issued by the FDA or any other
Governmental Entity exercising comparable authority, except
where the failure to so comply, individually or in the
aggregate, has not had, and is not reasonably likely to have, a
Merger Partner Material Adverse Effect. Neither Merger Partner
nor any of its Subsidiaries has received any notices or
correspondence from the FDA or any other Governmental Entity
exercising comparable authority, and to the knowledge of Merger
Partner there is no action or proceeding pending or threatened
(including any prosecution, injunction, seizure, civil fine,
suspension or recall), in each case alleging that Merger Partner
or any of its Subsidiaries is not currently in compliance with
any and all applicable laws, regulations or orders implemented
by the FDA or any other Governmental Entity exercising
comparable authority, except where the failure to so comply,
individually or in the aggregate, has not had, and is not
reasonably likely to have, a Merger Partner Material Adverse
Effect.
(c) There are no seizures, recalls,
market withdrawals, field notifications or corrective actions,
notifications of misbranding or adulteration, destruction
orders, safety alerts or similar actions relating to the safety
or efficacy of any products marketed or sold by Merger Partner
or any of its Subsidiaries being conducted, requested in writing
or, to the knowledge of Merger Partner, threatened by the FDA or
any other Governmental Entity exercising comparable authority.
Merger Partner has not, either voluntarily or involuntarily,
initiated, conducted or issued or caused to be initiated,
conducted or issued any recall, market withdrawal, safety alert
or other similar notice or action relating to the alleged lack
of safety or efficacy of any products marketed or sold by Merger
Partner or any of its Subsidiaries.
(d) The studies, tests and preclinical
and clinical trials conducted by or on behalf of Merger Partner
or any of its Subsidiaries were and, if still pending, are being
conducted in all material respects in accordance with
experimental protocols, procedures and controls pursuant to,
where applicable, accepted professional and scientific
standards; and neither Merger Partner nor any of its
Subsidiaries has received any notices or correspondence from the
FDA or any other Governmental Entity exercising comparable
authority requiring the termination, suspension or material
modification of any studies, tests or preclinical or clinical
trials conducted by or on behalf of Merger Partner or any of its
Subsidiaries, except for such terminations, suspensions or
material modifications that, individually or in the aggregate,
have not had, and are not reasonably likely to have, a Merger
Partner Material Adverse Effect.
(e) With respect to each unapproved drug
product marketed by or on behalf of Merger Partner or any of its
Subsidiaries, there currently is no Comparable Product that has
received FDA approval of a New Drug Application, and to the
knowledge of Merger Partner no other person is developing or has
developed, or is seeking or has sought FDA approval of a New
Drug Application for, a Comparable Product. For purposes hereof,
the term Comparable Product means a product
with the same or functionally similar active pharmaceutical
ingredient for use for the same or substantially similar
indication as any unapproved drug product marketed by or on
behalf of Merger Partner or any of its Subsidiaries.
(f) With respect to Merger Partners
product Tussionex, to the knowledge of Merger Partner no other
person is developing or has developed, or is seeking or has
sought FDA approval of an Abbreviated New Drug Application or a
Supplemental New Drug Application for, a product with the same
or functionally similar active pharmaceutical ingredient for use
for the same or substantially similar indication.
3.17 Employees.
(a) Substantially all current or past key
employees of Merger Partner or any of its Subsidiaries have
entered into confidentiality and assignment of inventions
agreements with Merger Partner or such Subsidiary, a copy or
form of which has previously been provided or made available to
Public Company. To the knowledge of Merger Partner, no employee
of Merger Partner or any Subsidiary of Merger Partner is in
violation of any term of any patent disclosure agreement,
non-competition agreement, or any restrictive
A-29
covenant to a former employer relating to the right of any such
employee to be employed by Merger Partner or any of its
Subsidiaries because of the nature of the business currently
conducted or currently proposed to be conducted by Merger
Partner or any of its Subsidiaries or to the use of trade
secrets or proprietary information of others, the consequences
of which, individually or in the aggregate, are reasonably
likely to have a Merger Partner Material Adverse Effect. To the
knowledge of Merger Partner, no key employee or group of
employees has any plans to terminate employment with Merger
Partner or its Subsidiaries.
(b) Neither Merger Partner nor any of its
Subsidiaries is a party to or otherwise bound by any collective
bargaining agreement, contract or other agreement or
understanding with a labor union or labor organization. Neither
Merger Partner nor any of its Subsidiaries is the subject of any
proceeding asserting that Merger Partner or any of its
Subsidiaries has committed an unfair labor practice or is
seeking to compel it to bargain with any labor union or labor
organization that, individually or in the aggregate, is
reasonably likely to have a Merger Partner Material Adverse
Effect, nor is there pending or, to the knowledge of Merger
Partner, threatened, any labor strike, dispute, walkout, work
stoppage, slow-down or lockout involving Merger Partner or any
of its Subsidiaries.
3.18 Insurance. Section 3.18
of the Merger Partner Disclosure Schedule sets forth a complete
and accurate list as of the date of this Agreement of all
insurance policies maintained by Merger Partner or any of its
Subsidiaries (the Merger Partner Insurance
Policies). Each Merger Partner Insurance Policy is in
full force and effect as of the date of this Agreement. As of
the date of this Agreement, there is no material claim by Merger
Partner or any of its Subsidiaries pending under any Merger
Partner Insurance Policy as to which coverage has been
questioned, denied or disputed by the underwriters of such
policy.
3.19 No Existing Discussions. As of
the date of this Agreement, neither Merger Partner nor any of
its Subsidiaries is engaged, directly or indirectly, in any
discussions or negotiations with any other party with respect to
an Acquisition Proposal.
3.20 Brokers; Fees and Expenses. No
agent, broker, investment banker, financial advisor or other
firm or person is or shall be entitled, as a result of any
action, agreement or commitment of Merger Partner or any of its
Affiliates, to any brokers, finders, financial
advisors or other similar fee or commission in connection
with any of the transactions contemplated by this Agreement,
except Jefferies & Company, Inc. whose fees and
expenses shall be paid by Merger Partner. Merger Partner has
provided or made available to Public Company a complete and
accurate copy of all agreements pursuant to which
Jefferies & Company, Inc. is entitled to any fees and
expenses in connection with any of the transactions contemplated
by this Agreement.
3.21 Controls and Procedures, Certifications and
Other Matters Relating to the Sarbanes Act.
(a) Merger Partner and each of its
Subsidiaries maintains accurate books and records reflecting its
assets and liabilities and maintains proper and adequate
internal control over financial reporting that provide
reasonable assurance that (i) transactions are executed
with managements authorization, (ii) transactions are
recorded as necessary to permit preparation of the consolidated
financial statements of Merger Partner and to maintain
accountability for Merger Partners consolidated assets,
(iii) access to assets of Merger Partner and its
Subsidiaries is permitted only in accordance with
managements authorization, (iv) the reporting of
assets of Merger Partner and its Subsidiaries is compared with
existing assets at regular intervals and (v) accounts,
notes and other receivables and inventory were recorded
accurately, and proper and adequate procedures are implemented
to effect the collection thereof on a current and timely basis.
(b) Neither Merger Partner nor any of its
officers has received notice from any Governmental Entity
questioning or challenging the accuracy, completeness or manner
of filing or submission of any filing with the SEC.
(c) Neither Merger Partner nor any of its
Subsidiaries has extended or maintained credit, arranged for the
extension of credit, modified or renewed an extension of credit,
in the form of a personal loan or otherwise, to or for any
director or executive officer of Merger Partner.
A-30
3.22 Certain Business Relationships With
Affiliates. No Affiliate of Merger Partner or of
any of its Subsidiaries (a) owns any property or right,
tangible or intangible, which is used in the business of Merger
Partner or any of its Subsidiaries, (b) has any claim or
cause of action against Merger Partner or any of its
Subsidiaries or (c) owes any money to, or is owed any money
by, Merger Partner or any of its Subsidiaries. Section 3.22
of the Merger Partner Disclosure Schedule describes any
commercial transactions or relationships between Merger Partner
or any of its Subsidiaries and any Affiliate thereof as of the
date of this Agreement.
3.23 Books and Records. The minute
books and other similar records of Merger Partner and each of
its Subsidiaries contain complete and accurate records of all
actions taken at any meetings of Merger Partners or such
Subsidiarys stockholders, Board of Directors or any
committee thereof and of all written consents executed in lieu
of the holding of any such meeting. The books and records of
Merger Partner and each of its Subsidiaries accurately reflect
in all material respects the assets, liabilities, business,
financial condition and results of operations of Merger Partner
or such Subsidiary and have been maintained in accordance with
good business and bookkeeping practices. Section 3.23 of
the Merger Partner Disclosure Schedule sets forth a list of all
bank accounts and safe deposit boxes of Merger Partner and its
Subsidiaries and the names of persons having signature authority
with respect thereto or access thereto.
ARTICLE IV
REPRESENTATIONS
AND WARRANTIES OF PUBLIC COMPANY AND THE
TRANSITORY
SUBSIDIARY
Public Company and the Transitory Subsidiary represent and
warrant to Merger Partner that the statements contained in this
Article IV are true and correct, except as expressly set
forth herein or in the disclosure schedule delivered by Public
Company and the Transitory Subsidiary to Merger Partner on the
date of this Agreement (the Public Company Disclosure
Schedule). The Public Company Disclosure Schedule
shall be arranged in sections corresponding to the numbered and
lettered sections contained in this Article IV and the
disclosure in any section shall qualify (1) the
corresponding section in this Article IV and (2) the
other sections in this Article IV only to the extent that
it is reasonably apparent from a reading of such disclosure that
it also qualifies or applies to such other sections. For
purposes hereof, to the knowledge of Public Company
and similar expressions mean the knowledge of the persons
identified on the Public Company Disclosure Schedule for this
purpose, as well as any other knowledge which such persons would
have possessed had they made reasonable inquiry with respect to
the matter in question.
4.1 Organization, Standing and
Power. Each of Public Company and the Transitory
Subsidiary is a corporation duly organized, validly existing and
in good standing under the laws of the jurisdiction of its
incorporation, has all requisite corporate power and authority
to own, lease and operate its properties and assets and to carry
on its business as currently conducted and as currently proposed
to be conducted, and is duly qualified to do business and is in
good standing as a foreign corporation in each jurisdiction
listed on Section 4.1(i) of the Public Company Disclosure
Schedule, which jurisdictions constitute the only jurisdictions
in which the character of the properties it owns, operates or
leases or the nature of its activities makes such qualification
necessary, except for such failures to be so organized,
qualified or in good standing, individually or in the aggregate,
that have not had, and are not reasonably likely to have, a
Public Company Material Adverse Effect. For purposes of this
Agreement, the term Public Company Material Adverse
Effect means any material adverse change, event,
circumstance or development with respect to, or material adverse
effect on, (i) the business, assets, liabilities, condition
(financial or other), or results of operations of Public Company
and its Subsidiaries, taken as a whole, or (ii) the ability
of Public Company and its Subsidiaries to consummate the
transactions contemplated by this Agreement; provided,
however, that the following shall not be deemed to be a
Public Company Material Adverse Effect: any change or event
caused by or resulting from (A) changes in prevailing
economic or market conditions in the United States or any other
jurisdiction in which Public Company has substantial business
operations (except to the extent those changes have a materially
disproportionate effect on Public Company and its Subsidiaries
as compared to other similarly situated participants in the
industries or markets in which Public Company and its
Subsidiaries operate), (B) changes or events, after the
date hereof, affecting the industries in which they operate
generally (except to
A-31
the extent those changes or events have a materially
disproportionate effect on Public Company and its Subsidiaries
as compared to other similarly situated participants in the
industries or markets in which Public Company and its
Subsidiaries operate), (C) changes, after the date hereof,
in generally accepted accounting principles or requirements
applicable to Public Company and its Subsidiaries (except to the
extent those changes have a materially disproportionate effect
on Merger Partner and its Subsidiaries as compared to other
similarly situated participants in the industries or markets in
which Public Company and its Subsidiaries operate),
(D) changes, after the date hereof, in laws, rules or
regulations of general applicability or interpretations thereof
by any Governmental Entity (except to the extent those changes
have a materially disproportionate effect on Public Company and
its Subsidiaries as compared to other similarly situated
participants in the industries or markets in which Public
Company and its Subsidiaries operate), (E) the execution,
delivery and performance of this Agreement or the consummation
of the transactions contemplated hereby or thereby or the
announcement thereof, (F) any outbreak of major hostilities
in which the United States is involved or any act of terrorism
within the United States or directed against its facilities or
citizens wherever located, or (G) the matters described on
Section 4.1(ii) of the Public Company Disclosure Schedule;
and provided, further, that in no event shall a
change in the public trading price of Public Company Common
Stock, by itself, be considered material or constitute a Public
Company Material Adverse Effect, although the underlying cause
of any change in the public trading price of Public Company
Common Stock may nonetheless be considered in determining the
occurrence of a Public Company Material Adverse Effect. For the
avoidance of doubt, the parties agree that the terms
material, materially and
materiality as used in this Agreement with an
initial lower case m shall have their respective
customary and ordinary meanings, without regard to the meanings
ascribed to Public Company Material Adverse Effect in the prior
sentence of this paragraph or Merger Partner Material Adverse
Effect in Section 3.1. Public Company has provided or made
available to Merger Partner complete and accurate copies of its
Certificate of Incorporation and Bylaws.
4.2 Capitalization.
(a) The authorized capital stock of
Public Company consists of 90,000,000 shares of Public
Company Common Stock and 5,000,000 shares of preferred
stock, $0.001 par value per share (Public Company
Preferred Stock). The rights and privileges of each
class of Public Companys capital stock are as set forth in
Public Companys Certificate of Incorporation. As of the
close of business on the business day prior to the date of this
Agreement, (i) 43,479,198 shares of Public Company
Common Stock were issued and outstanding, (ii) no shares of
Public Company Common Stock were held in the treasury of Public
Company or by Subsidiaries of Public Company, and (iii) no
shares of Public Company Preferred Stock were issued and
outstanding.
(b) Section 4.2(b) of the Public
Company Disclosure Schedule sets forth a complete and accurate
list of the number of issued and outstanding shares of Public
Company Common Stock that constitute restricted stock or that
are otherwise subject to a repurchase or redemption right or
right of first refusal in favor of Public Company.
(c) Section 4.2(c) of the Public
Company Disclosure Schedule sets forth a complete and accurate
list, as of the date of this Agreement, of: (i) all plans
under which outstanding options to purchase shares of Public
Company Common Stock (Public Company Stock
Options) were granted (collectively, Public
Company Stock Plans), indicating for each Public
Company Stock Plan, as of the close of business on the business
day prior to the date of this Agreement, the number of shares of
Public Company Common Stock subject to outstanding options under
such Plan and the number of shares of Public Company Common
Stock reserved for future issuance under such Plan; and
(ii) all outstanding Public Company Stock Options,
indicating with respect to each such Public Company Stock Option
the Public Company Stock Plan under which it was granted, the
number of shares of Public Company Common Stock subject to such
Public Company Stock Option and the exercise price. Public
Company has provided or made available to Merger Partner
complete and accurate copies of all Public Company Stock Plans
and the forms of all stock option agreements evidencing Public
Company Stock Options.
(d) Section 4.2(d) of the Public
Company Disclosure Schedule sets forth the number of shares of
Public Company Common Stock reserved for future issuance
pursuant to warrants or other
A-32
outstanding rights (other than Public Company Stock Options) to
purchase shares of Public Company Common Stock outstanding as of
the date of this Agreement (such outstanding warrants or other
rights, the Public Company Warrants) and the
agreement or other document under which such Public Company
Warrants were granted and sets forth a complete and accurate
list of all holders of Public Company Warrants indicating the
number and type of shares of Public Company Common Stock subject
to each Public Company Warrant, and the exercise price, the date
of grant and the expiration date thereof. Public Company has
provided or made available to Merger Partner complete and
accurate copies of the forms of agreements evidencing all Public
Company Warrants.
(e) Except (i) as set forth in this
Section 4.2 or in Article II and (ii) as reserved
for future grants under Public Company Stock Plans,
(A) there are no equity securities of any class of Public
Company, or any security exchangeable into or exercisable for
such equity securities, issued, reserved for issuance or
outstanding and (B) there are no options, warrants, equity
securities, calls, rights, commitments or agreements of any
character to which Public Company or any of its Subsidiaries is
a party or by which Public Company or any of its Subsidiaries is
bound obligating Public Company or any of its Subsidiaries to
issue, exchange, transfer, deliver or sell, or cause to be
issued, exchanged, transferred, delivered or sold, additional
shares of capital stock or other equity interests of Public
Company or any security or rights convertible into or
exchangeable or exercisable for any such shares or other equity
interests, or obligating Public Company or any of its
Subsidiaries to grant, extend, accelerate the vesting of,
otherwise modify or amend or enter into any such option,
warrant, equity security, call, right, commitment or agreement.
Public Company does not have any outstanding stock appreciation
rights, phantom stock, performance based rights or similar
rights or obligations. Other than the Public Company Stockholder
Agreements, neither Public Company nor any of its Affiliates is
a party to or is bound by any, and to the knowledge of Public
Company, there are no, agreements or understandings with respect
to the voting (including voting trusts and proxies) or sale or
transfer (including agreements imposing transfer restrictions)
of any shares of capital stock or other equity interests of
Public Company. Except as contemplated by this Agreement or
described in this Section 4.2(e), there are no registration
rights, and there is no rights agreement, poison
pill anti-takeover plan or other agreement or
understanding to which Public Company or any of its Subsidiaries
is a party or by which it or they are bound with respect to any
equity security of any class of Public Company. Stockholders of
Public Company are not entitled to dissenters or appraisal
rights under applicable state law in connection with the Merger.
(f) All outstanding shares of Public
Company Common Stock are, and all shares of Public Company
Common Stock subject to issuance as specified in
Sections 4.2(c) and 4.2(d) or pursuant to Article II,
upon issuance on the terms and conditions specified in the
instruments pursuant to which they are issuable, will be, duly
authorized, validly issued, fully paid and nonassessable and not
subject to or issued in violation of any purchase option, call
option, right of first refusal, preemptive right, subscription
right or any similar right under any provision of the DGCL,
Public Companys Certificate of Incorporation or Bylaws or
any agreement to which Public Company is a party or is otherwise
bound. There are no obligations, contingent or otherwise, of
Public Company or any of its Subsidiaries to repurchase, redeem
or otherwise acquire any shares of Public Company Common Stock.
4.3 Subsidiaries.
(a) Section 4.3(a) of the Public
Company Disclosure Schedule sets forth, for each Subsidiary of
Public Company: (i) its name; (ii) the number and type
of outstanding equity securities and a list of the holders
thereof; and (iii) the jurisdiction of organization.
(b) Each Subsidiary of Public Company is
a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction of its
incorporation, has all requisite corporate power and authority
to own, lease and operate its properties and assets and to carry
on its business as currently conducted and as currently proposed
to be conducted, and is duly qualified to do business and is in
good standing as a foreign corporation in each jurisdiction
where the character of its properties owned, operated or leased
or the nature of its activities makes such qualification
necessary, except for such failures to be so organized,
qualified or in good standing, individually or in the aggregate,
that have not had, and are not reasonably likely to have, a
Public Company Material Adverse Effect. All of the outstanding
shares of capital
A-33
stock and other equity securities or interests of each
Subsidiary of Public Company are duly authorized, validly
issued, fully paid, nonassessable and free of preemptive rights
and all such shares (other than directors qualifying
shares in the case of
non-U.S. Subsidiaries,
all of which Public Company has the power to cause to be
transferred for no or nominal consideration to Public Company or
Public Companys designee) are owned, of record and
beneficially, by Public Company or another of its Subsidiaries
free and clear of all security interests, liens, claims,
pledges, agreements, limitations in Public Companys voting
rights, charges or other encumbrances of any nature. There are
no outstanding or authorized options, warrants, rights,
agreements or commitments to which Public Company or any of its
Subsidiaries is a party or which are binding on any of them
providing for the issuance, disposition or acquisition of any
capital stock of any Subsidiary of Public Company. There are no
outstanding stock appreciation, phantom stock or similar rights
with respect to any Subsidiary of Public Company. There are no
voting trusts, proxies or other agreements or understandings
with respect to the voting of any capital stock of any
Subsidiary of Public Company.
(c) Public Company has provided or made
available to Merger Partner complete and accurate copies of the
charter, bylaws or other organizational documents of each
Subsidiary of Public Company.
(d) Public Company does not control
directly or indirectly or have any direct or indirect equity
participation or similar interest in any corporation,
partnership, limited liability company, joint venture, trust or
other business association or entity which is not a Subsidiary
of Public Company. There are no obligations, contingent or
otherwise, of Public Company or any of its Subsidiaries to
repurchase, redeem or otherwise acquire any shares of capital
stock of any Subsidiary of Public Company or to provide funds to
or make any material investment (in the form of a loan, capital
contribution or otherwise) in any Subsidiary of Public Company
or any other entity, other than guarantees of bank obligations
of Subsidiaries of Public Company entered into in the Ordinary
Course of Business.
4.4 Authority; No Conflict; Required
Filings and Consents.
(a) Each of Public Company and the
Transitory Subsidiary has all requisite corporate power and
authority to enter into this Agreement and, subject only to the
Public Company Stockholder Approval, to consummate the
transactions contemplated by this Agreement. Without limiting
the generality of the foregoing, the Public Company Board, at a
meeting duly called and held, by the unanimous vote of all
directors, (i) determined that the Merger is fair to and in
the best interests of Public Company and its stockholders,
(ii) directed that the Public Company Voting Proposals be
submitted to the stockholders of Public Company for their
approval and resolved to recommend that the stockholders of
Public Company vote in favor of the approval of the Public
Company Voting Proposals and (iii) to the extent necessary,
adopted a resolution having the effect of causing Public Company
not to be subject to any state takeover law or similar law that
might otherwise apply to the Merger and any other transactions
contemplated by this Agreement. The Board of Directors of the
Transitory Subsidiary, by unanimous written consent in lieu of a
meeting, adopted a resolution approving the Merger Agreement and
declaring its advisability. The execution and delivery of this
Agreement and the consummation of the transactions contemplated
by this Agreement by Public Company and the Transitory
Subsidiary have been duly authorized by all necessary corporate
action on the part of each of Public Company and the Transitory
Subsidiary, subject only to the required receipt of the Public
Company Stockholder Approval and the adoption of this Agreement
by Public Company in its capacity as the sole stockholder of the
Transitory Subsidiary. Public Company agrees to take the
appropriate action to so adopt this Agreement promptly following
the date hereof. This Agreement has been duly executed and
delivered by each of Public Company and the Transitory
Subsidiary and constitutes the valid and binding obligation of
each of Public Company and the Transitory Subsidiary,
enforceable in accordance with its terms, subject to the
Bankruptcy and Equity Exception.
(b) The execution and delivery of this
Agreement by each of Public Company and the Transitory
Subsidiary do not, and the consummation by Public Company and
the Transitory Subsidiary of the transactions contemplated by
this Agreement shall not, (i) conflict with, or result in
any violation or breach of, any provision of the Certificate of
Incorporation or Bylaws of Public Company or the Transitory
Subsidiary or of the charter, bylaws or other organizational
document of any other Subsidiary of Public Company,
A-34
(ii) conflict with, or result in any violation or breach
of, or constitute (with or without notice or lapse of time, or
both) a default (or give rise to a right of termination,
cancellation or acceleration of any obligation or loss of any
material benefit) under, or require a consent or waiver under,
constitute a change in control under, require the payment of a
penalty under or result in the imposition of any Lien on Public
Companys or any of its Subsidiaries assets under any
of the terms, conditions or provisions of any note, bond,
mortgage, indenture, lease, license, contract or other
agreement, instrument or obligation to which Public Company or
any of its Subsidiaries is a party or by which any of them or
any of their properties or assets may be bound, or
(iii) subject to obtaining the Public Company Stockholder
Approval and compliance with the requirements specified in
clauses (i) through (viii) of Section 4.4(c),
conflict with or violate any permit, concession, franchise,
license, judgment, injunction, order, decree, statute, law,
ordinance, rule or regulation applicable to Public Company or
any of its Subsidiaries or any of its or their properties or
assets, except in the case of clauses (ii) and
(iii) of this Section 4.4(b) for any such conflicts,
violations, breaches, defaults, terminations, cancellations,
accelerations or losses that, individually or in the aggregate,
have not had, and are not reasonably likely to have, a Public
Company Material Adverse Effect. Section 4.4(b) of the
Public Company Disclosure Schedule lists all consents, waivers
and approvals under any of Public Companys or any of its
Subsidiaries agreements, licenses or leases required to be
obtained in connection with the consummation of the transactions
contemplated by this Agreement, which, if individually or in the
aggregate were not obtained, would result in a material loss of
benefits to Public Company, Merger Partner or the Surviving
Corporation as a result of the Merger.
(c) No consent, approval, license,
permit, order or authorization of, or registration, declaration,
notice or filing with, any Governmental Entity or any stock
market or stock exchange on which shares of Public Company
Common Stock are listed for trading is required by or with
respect to Public Company or any of its Subsidiaries in
connection with the execution and delivery of this Agreement or
the consummation by Public Company or the Transitory Subsidiary
of the transactions contemplated by this Agreement, except for
(i) the filing of the Certificate of Merger with the
Delaware Secretary of State, (ii) the filing of the
Registration Statement with the SEC in accordance with the
Securities Act, (iii) the filing of the Proxy
Statement/Prospectus with the SEC in accordance with the
Exchange Act, (iv) the filing of such reports, schedules or
materials under Section 13 or Section 15(d) of or
Rule 14a-12
under the Exchange Act and materials under Rule 165 and
Rule 425 under the Securities Act as may be required in
connection with this Agreement and the transactions contemplated
hereby and thereby, (v) such consents, approvals, orders,
authorizations, registrations, declarations and filings as may
be required under applicable state securities laws and the laws
of any foreign country, (vi) the filing of a Notification
Form: Listing of Additional Shares with NASDAQ, (vii) an
application for re-listing by listed issuer under NASDAQ
Marketplace Rule 4340 and (viii) such other consents,
authorizations, orders, filings, approvals and registrations
that, individually or in the aggregate, if not obtained or made,
would not be reasonably likely to have a Public Company Material
Adverse Effect.
(d) The affirmative vote in favor of the
Public Company Voting Proposals by the holders of a majority of
the votes represented by the outstanding shares of Public
Company Common Stock at the Public Company Meeting is the only
vote of the holders of any class or series of Public
Companys capital stock or other securities necessary to
approve the Public Company Voting Proposals. There are no bonds,
debentures, notes or other indebtedness of Public Company having
the right to vote (or convertible into, or exchangeable for,
securities having the right to vote) on any matters on which
stockholders of Public Company may vote.
4.5 SEC Filings; Financial Statements;
Information Provided.
(a) Public Company has filed all
registration statements, forms, reports, certifications and
other documents required to be filed by Public Company with the
SEC since January 1, 2006 and has made available to Merger
Partner copies of all registration statements, forms, reports,
certifications and other documents filed by Public Company with
the SEC since January 1, 2006, including all certifications
and statements required by
(i) Rule 13a-14
or 15d-14
under the Exchange Act or (ii) 18 U.S. C. §1350
(Section 906 of the Sarbanes-Oxley Act of 2002 (the
Sarbanes Act)). All such registration
statements, forms, reports, certifications and other documents
(including those that Public Company may file after the date
hereof until the Closing) are referred to herein as the
Public Company SEC Documents. All Public
Company SEC
A-35
Documents are publicly available on the SECs EDGAR system.
Public Company has made available to Merger Partner copies of
all comment letters received by Public Company from the staff of
the SEC since January 1, 2006 and all responses to such
comment letters by or on behalf of Public Company. All Public
Company SEC Documents (A) were or will be filed or deemed
filed on a timely basis, (B) at the time filed, were or
will be prepared in compliance in all material respects with the
applicable requirements of the Securities Act and the Exchange
Act, as the case may be, and the rules and regulations of the
SEC thereunder applicable to such Public Company SEC Documents
and (C) did not or will not at the time they were or are
filed contain any untrue statement of a material fact or omit to
state a material fact required to be stated in such Public
Company SEC Documents or necessary in order to make the
statements in such Public Company SEC Documents, in the light of
the circumstances under which they were made, not misleading. No
Subsidiary of Public Company is subject to the reporting
requirements of Section 13 or Section 15(d) of the
Exchange Act. As used in this Section 4.5, the term
file shall be broadly construed to include any
manner in which a document or information is furnished, supplied
or otherwise made available to the SEC.
(b) Each of the consolidated financial
statements (including, in each case, any related notes and
schedules) contained or to be contained in Public Company SEC
Documents at the time filed (i) complied or will comply as
to form in all material respects with applicable accounting
requirements and the published rules and regulations of the SEC
with respect thereto (including, without limitation,
Regulation S-X),
(ii) were or will be prepared in accordance with GAAP
applied on a consistent basis throughout the periods involved
and at the dates involved (except as may be indicated in the
notes to such financial statements or, in the case of unaudited
interim financial statements, as permitted by the SEC on
Form 10-Q
under the Exchange Act) and (iii) fairly presented or will
fairly present the consolidated financial position of Public
Company and its Subsidiaries as of the dates thereof and the
consolidated results of its operations and cash flows for the
periods indicated, consistent with the books and records of
Public Company and its Subsidiaries, except that the unaudited
interim financial statements were or are subject to normal and
recurring year-end adjustments which were not or will not be
material in amount or effect. The consolidated balance sheet of
Public Company as of December 31, 2007 contained in Public
Companys Annual Report on
Form 10-K,
as amended, for the period ended December 31, 2007 (the
Public Company
Form 10-K)
filed with the SEC is referred to herein as the Public
Company Balance Sheet.
(c) Deloitte & Touche LLP,
Public Companys current auditors, is and has been at all
times since its engagement by Public Company
(i) independent with respect to Public Company
within the meaning of
Regulation S-X
and (ii) in compliance with subsections (g) through
(l) of Section 10A of the Exchange Act (to the extent
applicable) and the related rules of the SEC and the Public
Company Accounting Oversight Board.
(d) The information in the Registration
Statement to be supplied by or on behalf of Public Company for
inclusion or incorporation by reference in the Registration
Statement, or to be included or supplied by or on behalf of
Public Company for inclusion in any
Regulation M-A
Filing, shall not at the time the Registration Statement or any
such
Regulation M-A
Filing is filed with the SEC, at any time it is amended or
supplemented or at the time the Registration Statement is
declared effective by the SEC, as applicable, contain any untrue
statement of a material fact or omit to state any material fact
required to be stated therein or necessary in order to make the
statements therein not misleading. The information to be
supplied by or on behalf of Public Company for inclusion in the
Proxy Statement/Prospectus to be sent to (i) the
stockholders of Public Company in connection with the Public
Company Meeting and (ii) the stockholders of Merger
Partner, which information shall be deemed to include all
information about or relating to Public Company, the Public
Company Voting Proposals or the Public Company Meeting, shall
not, on the date the Proxy Statement/Prospectus is first mailed
to stockholders of Public Company or Merger Partner, or at the
time of the Public Company Meeting or at the Effective Time,
contain any statement that, at such time and in light of the
circumstances under which it shall be made, is false or
misleading with respect to any material fact, or omit to state
any material fact necessary in order to make the statements made
in the Proxy Statement/Prospectus not false or misleading; or
omit to state any material fact necessary to correct any
statement in any earlier communication with respect to the
solicitation of proxies for the Public Company Meeting that has
become false or misleading. If at any time prior to the
Effective Time any fact or event relating to Public Company or
A-36
any of its Affiliates which should be set forth in an amendment
to the Registration Statement or a supplement to the Proxy
Statement/Prospectus should be discovered by Public Company or
should occur, Public Company shall promptly inform Merger
Partner of such fact or event.
4.6 No Undisclosed
Liabilities. Except as disclosed in the Public
Company
Form 10-K
or any Public Company SEC Documents filed after the filing of
the Public Company
Form 10-K
and prior to the date of this Agreement (together with the
Public Company
Form 10-K,
the Public Company Recent SEC Documents), and
except for normal and recurring liabilities incurred since the
date of the Public Company Balance Sheet in the Ordinary Course
of Business, Public Company and its Subsidiaries do not have any
liabilities (whether known or unknown, whether absolute or
contingent, whether liquidated or unliquidated, whether due or
to become due, and whether or not required to be reflected in
financial statements (including the notes thereto) in accordance
with GAAP), that, individually or in the aggregate, are
reasonably likely to have a Public Company Material Adverse
Effect.
4.7 Absence of Certain Changes or
Events. Except as disclosed in the Public Company
Recent SEC Documents, since the date of the Public Company
Balance Sheet, Public Company and its Subsidiaries have
conducted their respective businesses only in the Ordinary
Course of Business and, since such date, there has not been
(i) any change, event, circumstance, development or effect
that, individually or in the aggregate, has had, or is
reasonably likely to have, a Public Company Material Adverse
Effect; or (ii) any other action or event that would have
required the consent of Merger Partner pursuant to
Section 5.2 of this Agreement had such action or event
occurred after the date of this Agreement.
4.8 Taxes.
(a) Each of Public Company and its
Subsidiaries has properly filed on a timely basis all material
Tax Returns that it was required to file, and all such Tax
Returns were true, correct and complete in all material
respects. Each of Public Company and its Subsidiaries has paid
on a timely basis all Taxes that were due and payable. The
unpaid Taxes of Public Company and each of its Subsidiaries for
Tax periods through the date of the Public Company Balance Sheet
do not exceed the accruals and reserves for Taxes (excluding
accruals and reserves for deferred Taxes established to reflect
timing differences between book and Tax income) set forth on the
Public Company Balance Sheet and all unpaid Taxes of Public
Company and each of its Subsidiaries for all Tax periods
commencing after the date of the Public Company Balance Sheet
arose in the Ordinary Course of Business and are of a type and
amount commensurate with Taxes attributable to prior similar
periods. Neither Public Company nor any of its Subsidiaries is
or has ever been a member of a group of corporations with which
it has filed (or been required to file) consolidated, combined
or unitary Tax Returns, other than a group of which the common
parent is Public Company. Neither Public Company nor any of its
Subsidiaries (i) has any liability under Treasury
Regulations
Section 1.1502-6
(or any comparable or similar provision of federal, state, local
or foreign law), as a transferee or successor, pursuant to any
contractual obligation, or otherwise for any Taxes of any person
other than Public Company or any of its Subsidiaries, or
(ii) is a party to or bound by any Tax indemnity, Tax
sharing, Tax allocation or similar agreement. All material Taxes
that Public Company or any of its Subsidiaries was required by
law to withhold or collect have been duly withheld or collected
and, to the extent required, have been properly paid to the
appropriate Governmental Entity.
(b) Public Company has delivered or made
available to Merger Partner (i) complete and correct copies
of all Tax Returns of Public Company and any of its Subsidiaries
relating to Taxes for all taxable periods for which the
applicable statute of limitations has not yet expired, and
(ii) complete and correct copies of all private letter
rulings, revenue agent reports, information document requests,
notices of proposed deficiencies, deficiency notices, protests,
petitions, closing agreements, settlement agreements, pending
ruling requests and any similar documents submitted by, received
by, or agreed to by or on behalf of Public Company or any of its
Subsidiaries relating to Taxes for all taxable periods for which
the statute of limitations has not yet expired. The federal
income Tax Returns of Public Company and each of its
Subsidiaries have been audited by the Internal Revenue Service
or are closed by the applicable statute of limitations for all
taxable years through the taxable year specified in
Section 4.8(b) of the Public Company Disclosure Schedule.
No examination or audit of any Tax Return of Public Company or
any of its Subsidiaries
A-37
by any Governmental Entity is currently in progress or, to the
knowledge of Public Company, threatened or contemplated. Neither
Public Company nor any of its Subsidiaries has been informed by
any jurisdiction that the jurisdiction believes that Public
Company or any of its Subsidiaries was required to file any Tax
Return that was not filed. Neither Public Company nor any of its
Subsidiaries has (i) waived any statute of limitations with
respect to Taxes or agreed to extend the period for assessment
or collection of any Taxes, (ii) requested any extension of
time within which to file any Tax Return, which Tax Return has
not yet been filed, or (iii) executed or filed any power of
attorney with any taxing authority.
(c) Neither Public Company nor any of its
Subsidiaries has made any payment, is obligated to make any
payment, or is a party to any agreement that could obligate it
to make any payment that may be treated as an excess
parachute payment under Section 280G of the Code
(without regard to Sections 280G(b)(4) and 280G(b)(5) of
the Code).
(d) There are no adjustments under
Section 481 of the Code (or any similar adjustments under
any provision of the Code or the corresponding foreign, state or
local Tax laws) that are required to be taken into account by
Public Company or any of its Subsidiaries in any period ending
after the Closing Date by reason of a change in method of
accounting in any taxable period ending on or before the Closing
Date or as a result of the consummation of the transactions
contemplated by this Agreement.
(e) Neither Public Company nor any of its
Subsidiaries has been a United States real property holding
corporation within the meaning of Section 897(c)(2) of the
Code during the applicable period specified in
Section 897(c)(l)(A)(ii) of the Code.
(f) Neither Public Company nor any of its
Subsidiaries has distributed to its stockholders or security
holders stock or securities of a controlled corporation, nor has
stock or securities of Public Company or any of its Subsidiaries
been distributed, in a transaction to which Section 355 of
the Code applies (i) in the two years prior to the date of
this Agreement or (ii) in a distribution that could
otherwise constitute part of a plan or series
of related transactions (within the meaning of
Section 355(e) of the Code) that includes the transactions
contemplated by this Agreement.
(g) There are no liens or other
encumbrances with respect to Taxes upon any of the assets or
properties of Public Company or any of its Subsidiaries, other
than with respect to Taxes not yet due and payable or being
contested in good faith by appropriate proceedings.
(h) Neither Public Company nor any of its
Subsidiaries will be required to include any item of income in,
or exclude any item of deduction from, taxable income for any
period (or any portion thereof) ending after the Closing Date as
a result of any (i) deferred intercompany gain or any
excess loss account described in Treasury Regulations under
Section 1502 of the Code (or any corresponding provision of
state, local or foreign Tax law), (ii) closing agreement as
described in Section 7121 of the Code (or any corresponding
or similar provision of state, local or foreign Tax law)
executed on or prior to the Closing Date, (iii) installment
sale or other open transaction disposition made on or prior to
the Closing Date, or (iv) prepaid amount received on or
prior to the Closing Date.
(i) Neither Public Company nor any of its
Subsidiaries has participated in any reportable
transaction as defined in
section 1.6011-4(b)
of the Treasury Regulations or any analogous provision of state
or local law.
4.9 Owned and Leased Real
Properties.
(a) Neither Public Company nor any of its
Subsidiaries owns or has ever owned any real property.
(b) Section 4.9(b) of the Public
Company Disclosure Schedule sets forth a complete and accurate
list of all real property leased, subleased or licensed by
Public Company or any of its Subsidiaries (collectively, the
Public Company Leases) and the location of
the premises. Neither Public Company, nor any of its
Subsidiaries nor, to the knowledge of Public Company, any other
party is in default under any of the Public Company Leases,
except where the existence of such defaults, individually or in
the aggregate, has not had, and is not reasonably likely to
have, a Public Company Material Adverse Effect. Neither Public
Company
A-38
nor any of its Subsidiaries leases, subleases or licenses any
real property to any person other than Public Company and its
Subsidiaries. Public Company has provided or made available to
Merger Partner complete and accurate copies of all Public
Company Leases.
4.10 Intellectual Property.
(a) Public Company and its Subsidiaries
own, license or otherwise possess legally enforceable rights to
use all Intellectual Property used or necessary to conduct the
business of Public Company and its Subsidiaries as currently
conducted, or that would be used or necessary as such business
is currently proposed to be conducted (excluding
currently-available, off-the-shelf software programs that are
licensed by Public Company pursuant to shrink wrap
licenses under which aggregate fees and royalties paid to the
licensor do not exceed $50,000 annually), the absence of which,
individually or in the aggregate, is reasonably likely to have a
Public Company Material Adverse Effect.
(b) The execution and delivery of this
Agreement and consummation of the Merger will not result in the
breach of, or create on behalf of any third party the right to
terminate or modify, (i) any license, sublicense or other
agreement relating to any Intellectual Property owned by Public
Company or any of its Subsidiaries that is material to the
business of Public Company and its Subsidiaries, taken as a
whole, including software that is used in the development or
manufacture of or forms a part of any product or service sold by
or expected to be sold by Public Company or any of its
Subsidiaries (the Public Company Intellectual
Property) or (ii) any license, sublicense and
other agreement as to which Public Company or any of its
Subsidiaries is a party and pursuant to which Public Company or
any of its Subsidiaries is authorized to use any third party
Intellectual Property that is material to the business of Public
Company and its Subsidiaries, taken as a whole, including
software that is used in the development or manufacture of or
forms a part of any product or service sold by or expected to be
sold by Public Company or any of its Subsidiaries (the
Public Company Third Party Intellectual
Property). Section 4.10(b)(i) of the Public
Company Disclosure Schedule sets forth a complete and accurate
list of Public Company Intellectual Property (other than
unregistered copyrights, trade secrets and confidential
information) and Section 4.10(b)(ii) sets forth a complete
and accurate list of all Public Company Third Party Intellectual
Property.
(c) All patents and registrations and
applications for Trademarks, service marks and copyrights which
are held by Public Company or any of its Subsidiaries and that
are material to the business of Public Company and its
Subsidiaries, taken as a whole, are valid and subsisting. Public
Company and its Subsidiaries have taken reasonable measures to
protect the proprietary nature of the Public Company
Intellectual Property. To the knowledge of Public Company, no
other person or entity is infringing, violating or
misappropriating any of the Public Company Intellectual Property
or Public Company Third Party Intellectual Property, except for
infringements, violations or misappropriations that,
individually or in the aggregate, are not reasonably likely to
have a Public Company Material Adverse Effect.
(d) To the knowledge of Public Company,
none of the (i) products previously or currently sold by
Public Company or any of its Subsidiaries or (ii) business
or activities previously or currently conducted by Public
Company or any of its Subsidiaries infringes, violates or
constitutes a misappropriation of, any Intellectual Property of
any third party, except for such infringements, violations and
misappropriations that, individually or in the aggregate, have
not had, and are not reasonably likely to have, a Public Company
Material Adverse Effect. Neither Public Company nor any of its
Subsidiaries has received any complaint, claim or notice
alleging any such infringement, violation or misappropriation.
4.11 Agreements, Contracts and Commitments.
(a) Section 4.11(a) of the Public
Company Disclosure Schedule sets forth a complete and accurate
list of (i) each contract or agreement (or group of related
agreements) that is a material contract (as defined in
Item 601(b)(10) of
Regulation S-K
but without regard to the exceptions contained therein for
ordinary course agreements) with respect to Public Company and
its Subsidiaries and (ii) any other contract or agreement
(or group of related agreements) that gives any right to or
imposes any liability on Public Company or any Subsidiary that
is reasonably expected to involve, after the date of this
Agreement, more than $150,000 (including, without limitation,
leases, indebtedness, guarantees, Liens and employment
agreements)
A-39
(collectively, the Public Company Material
Contracts), other than those Public Company Material
Contracts identified on the exhibit index of any Public Company
Recent SEC Document. Notwithstanding the foregoing, the term
Public Company Material Contracts shall not include any contract
or agreement (or group of related agreements) that (i) is
terminable without cause by Public Company or its Subsidiaries
with less than 120 days notice without penalty, including
the payment of any termination fee or refund of amounts
previously received, or (ii) is for the purchase or sale of
products or for the furnishing or receipt of services
(A) which calls for performance over a period of less than
one year or (B) which involves an aggregate of less than
$150,000.
(b) Section 4.11(b) of the Public
Company Disclosure Schedule sets forth a complete and accurate
list of each contract or agreement to which Public Company or
any of its Subsidiaries is a party or bound with any Affiliate
of Public Company (other than any Subsidiary that is a direct or
indirect wholly owned subsidiary of Public Company). Except as
disclosed in the Public Company Recent SEC Documents, neither
Public Company nor any of its Subsidiaries has entered into any
transaction with any Affiliate of Public Company or any of its
Subsidiaries or any transaction that would be subject to proxy
statement disclosure pursuant to Item 404 of
Regulation S-K.
(c) There is no non-competition or other
similar agreement, commitment, judgment, injunction or order to
which Public Company or any of its Subsidiaries is a party or is
subject that has or could reasonably be expected to have the
effect of prohibiting or impairing in any material respect the
conduct of the business of Public Company or any of its
Subsidiaries or Merger Partner or any of its Subsidiaries as
currently conducted and as currently proposed to be conducted in
any material respect. Neither Public Company nor any of its
Subsidiaries has entered into (or is otherwise bound by) any
agreement under which it is restricted in any material respect
from selling, licensing or otherwise distributing any of its
technology or products, or providing services to, customers or
potential customers or any class of customers, in any geographic
area, during any period of time or any segment of the market or
line of business.
(d) Except as identified on the exhibit
index of any Public Company Recent SEC Document, neither Public
Company nor any of its Subsidiaries is a party to any agreement
under which is licensed any material Intellectual Property to or
from any third party (excluding currently-available,
off-the-shelf software programs that are licensed by Public
Company or any of its Subsidiaries pursuant to shrink
wrap licenses under which aggregate fees and royalties
paid to the licensor do not exceed $50,000 annually).
(e) Public Company has provided or made
available to Merger Partner a complete and accurate copy of each
agreement listed in Section 4.10 or Section 4.11 of
the Merger Partner Disclosure Schedule or identified on the
exhibit index of any Public Company Recent SEC Document. With
respect to each agreement so listed or identified: (i) the
agreement is legal, valid, binding and enforceable and in full
force and effect; (ii) the agreement will continue to be
legal, valid, binding and enforceable and in full force and
effect immediately following the Closing in accordance with the
terms thereof as in effect immediately prior to the Closing; and
(iii) neither Public Company nor any of its Subsidiaries
nor, to the knowledge of Public Company, any other party, is in
breach or violation of, or default under, any such agreement,
and no event has occurred, is pending or, to the knowledge of
Public Company, is threatened, which, with or without notice or
lapse of time, or both, would constitute a breach, violation or
default by Public Company or any of its Subsidiaries or, to the
knowledge of Public Company, any other party under such
agreement, except for breaches, violations or defaults that,
individually or in the aggregate, have not had, and are not
reasonably likely to have, a Public Company Material Adverse
Effect. Neither Public Company nor any of its Subsidiaries has
received any notice in writing from any other party, and, to the
knowledge of Public Company, no party has threatened, to
terminate, cancel, fail to renew or otherwise materially modify
any such agreements the loss of which, individually or in the
aggregate, is reasonably likely to have a Public Company
Material Adverse Effect.
4.12 Litigation. Except as
disclosed in the Public Company Recent SEC Documents, there is
no action, suit, proceeding, claim, arbitration or investigation
before any Governmental Entity or before any arbitrator that is
pending or, to the knowledge of Public Company, has been
threatened in writing against Public Company or any of its
Subsidiaries that (a) seeks either damages in excess of
$150,000 or equitable relief or (b) in any manner
challenges or seeks to prevent, enjoin, alter or delay the
transactions contemplated
A-40
by this Agreement. There are no material judgments, orders or
decrees outstanding against Public Company or any of its
Subsidiaries.
4.13 Environmental Matters. Except
as disclosed in the Public Company Recent SEC Documents and
except for such matters that, individually or in the aggregate,
have not had, and are not reasonably likely to have, a Public
Company Material Adverse Effect:
(i) Public Company and its Subsidiaries
have complied with all applicable Environmental Laws;
(ii) to the actual knowledge of Public
Company, and without independent investigation, the properties
currently owned, leased or operated by Public Company and its
Subsidiaries (including soils, groundwater, surface water,
buildings or other structures) are not contaminated with any
Hazardous Substances at levels or in a condition that would
violate applicable Environmental Laws;
(iii) to the actual knowledge of Public
Company, and without independent investigation, the properties
formerly owned, leased or operated by Public Company or any of
its Subsidiaries were not, during the period of ownership, use
or operation by Public Company or any of its Subsidiaries,
contaminated with Hazardous Substances at levels or in a
condition that would violate applicable Environmental Laws;
(iv) neither Public Company nor any of
its Subsidiaries are subject to liability for any Hazardous
Substance disposal or contamination on the property of any third
party;
(v) neither Public Company nor any of its
Subsidiaries have released any Hazardous Substance into the
environment;
(vi) neither Public Company nor any of
its Subsidiaries has received any notice, demand, letter, claim
or request for information alleging that Public Company or any
of its Subsidiaries may be in violation of, liable under or have
obligations under any Environmental Law;
(vii) neither Public Company nor any of
its Subsidiaries is subject to any orders, decrees, injunctions
or other arrangements with any Governmental Entity or is subject
to any indemnity or other agreement with any third party
relating to liability under any Environmental Law or relating to
Hazardous Substances; and
(viii) there are no circumstances or
conditions involving Public Company, any of its Subsidiaries or
any of their respective properties that could reasonably be
expected to result in any claims, liability, obligations,
investigations, costs or restrictions on the ownership, use or
transfer of any property of Public Company or any of its
Subsidiaries pursuant to any Environmental Law.
4.14 Employee Benefit Plans.
(a) Section 4.14(a) of the Public
Company Disclosure Schedule sets forth a complete and accurate
list of all Employee Benefit Plans maintained, or contributed
to, by Public Company or any of its Subsidiaries or any of their
respective ERISA Affiliates (collectively, the Public
Company Employee Plans).
(b) With respect to each Public Company
Employee Plan, Public Company has provided or made available to
Merger Partner, a complete and accurate copy of (i) such
plan (or a written summary of any unwritten plan), (ii) the
most recent annual report (Form 5500) filed with the
IRS, (iii) each trust agreement, group annuity contract and
summary plan description, if any, relating to such Public
Company Employee Plan, (iv) the most recent financial
statements for each Public Company Employee Plan that is funded,
(v) all personnel, payroll and employment manuals and
policies, (vi) all employee handbooks and (vii) all
reports regarding the satisfaction of the nondiscrimination
requirements of Sections 410(b), 401(k) and 401(m) of the
Code.
(c) Each Public Company Employee Plan has
been administered in all material respects in accordance with
ERISA, the Code and all other applicable laws and the
regulations thereunder and in accordance with its terms and each
of Public Company and its Subsidiaries and their respective
ERISA
A-41
Affiliates has in all material respects met its obligations with
respect to such Public Company Employee Plan and has made all
required contributions thereto (or reserved such contributions
on the Public Company Balance Sheet). Public Company and its
Subsidiaries and each of their respective ERISA Affiliates and
each Public Company Employee Plan are in compliance in all
material respects with the currently applicable provisions of
ERISA and the Code and the regulations thereunder (including
Section 4980B of the Code, Subtitle K, Chapter 100 of
the Code and Sections 601 through 608 and Section 701
et seq. of ERISA). All filings and reports as to each Public
Company Employee Plan required to have been submitted to the IRS
or to the United States Department of Labor have been timely
submitted. With respect to Public Company Employee Plans, no
event has occurred, and to the knowledge of Public Company,
there exists no condition or set of circumstances in connection
with which Public Company or any of its Subsidiaries could be
subject to any liability that is reasonably likely, individually
or in the aggregate, to have a Public Company Material Adverse
Effect under ERISA, the Code or any other applicable law.
(d) With respect to Public Company
Employee Plans, there are no benefit obligations for which
contributions have not been made or properly accrued and there
are no benefit obligations that have not been accounted for by
reserves, or otherwise properly footnoted in accordance with
GAAP, on the financial statements of Public Company, which
obligations are reasonably likely, individually or in the
aggregate, to have a Public Company Material Adverse Effect. The
assets of each Public Company Employee Plan that is funded are
reported at their fair market value on the books and records of
such Public Company Employee Plan.
(e) All Public Company Employee Plans
that are intended to be qualified under Section 401(a) of
the Code have received determination letters from the IRS to the
effect that such Public Company Employee Plans are qualified and
the plans and trusts related thereto are exempt from federal
income taxes under Sections 401(a) and 501(a),
respectively, of the Code, no such determination letter has been
revoked and revocation has not been threatened, and no such
Employee Benefit Plan has been amended or operated since the
date of its most recent determination letter or application
therefor in any respect, and no act or omission has occurred,
that would adversely affect its qualification or materially
increase its cost. Each Public Company Employee Plan that is
required to satisfy Section 401(k)(3) or
Section 401(m)(2) of the Code has been tested for
compliance with, and satisfies the requirements of,
Section 401(k)(3) and Section 401(m)(2) of the Code,
as the case may be, for each plan year ending prior to the
Closing Date.
(f) Neither Public Company nor any of its
Subsidiaries nor any of their respective ERISA Affiliates has
(i) ever maintained a Public Company Employee Benefit Plan
that was ever subject to Section 412 of the Code or
Title IV of ERISA or (ii) ever been obligated to
contribute to a multiemployer plan (as defined in
Section 4001(a)(3) of ERISA). No Public Company Employee
Plan is funded by, associated with or related to a
voluntary employees beneficiary association
within the meaning of Section 501(c)(9) of the Code. No
Public Company Employee Plan holds securities issued by Public
Company or any of its Subsidiaries or any of their respective
ERISA Affiliates.
(g) Each Public Company Employee Plan is
amendable and terminable unilaterally by Public Company and any
of Public Companys Subsidiaries that are a party thereto
or covered thereby at any time without liability to Public
Company or any of its Subsidiaries as a result thereof (other
than for benefits accrued through the date of termination or
amendment and reasonable administrative expenses related
thereto), and no Public Company Employee Plan, plan
documentation or agreement, summary plan description or other
written communication distributed generally to employees by its
terms prohibits Public Company or any of its Subsidiaries from
amending or terminating any such Public Company Employee Plan.
The investment vehicles used to fund Public Company
Employee Plans may be changed at any time without incurring a
material sales charge, surrender fee or other similar expense.
(h) Except as identified on the exhibit
index of any Public Company Recent SEC Document, neither Public
Company nor any of its Subsidiaries is a party to any oral or
written (i) agreement with any stockholders, director,
executive officer or other employee of Public Company or any of
its Subsidiaries (A) the benefits of which are contingent,
or the terms of which are materially altered, upon the
occurrence of a transaction involving Public Company or any of
its Subsidiaries of the nature of any of the
A-42
transactions contemplated by this Agreement, (B) providing
any term of employment or compensation guarantee or
(C) providing severance benefits or other benefits after
the termination of employment of such director, executive
officer or employee; (ii) agreement, plan or arrangement
under which any person may receive payments from Public Company
or any of its Subsidiaries that may be subject to the tax
imposed by Section 4999 of the Code or included in the
determination of such persons parachute
payment under Section 280G of the Code, without
regard to Section 280G(b)(4); or (iii) agreement or
plan binding Public Company or any of its Subsidiaries,
including any stock option plan, stock appreciation right plan,
restricted stock plan, stock purchase plan or severance benefit
plan, any of the benefits of which shall be increased, or the
vesting of the benefits of which shall be accelerated, by the
occurrence of any of the transactions contemplated by this
Agreement or the value of any of the benefits of which shall be
calculated on the basis of any of the transactions contemplated
by this Agreement.
(i) None of the Public Company Employee
Plans promises or provides retiree medical or other retiree
welfare benefits to any person, except as required by applicable
law.
(j) Each Public Company Employee Plan
that is a nonqualified deferred compensation plan
(as defined in Code Section 409A(d)(1)) has been operated
since January 1, 2005 in good faith reasonable compliance
with Code Section 409A and IRS Notice
2005-1. No
Public Company Employee Plan that is a nonqualified
deferred compensation plan has been materially modified
(as determined under Notice
2005-1)
after October 3, 2004. No event has occurred that would be
treated by Code Section 409A(b) as a transfer of property
for purposes of Code Section 83. Since Public Company
became subject to the reporting requirements of Section 13
or Section 15(d) of the Exchange Act, no stock option or
equity unit option granted under any Public Company Employee
Plan has an exercise price that has been or may be less than the
fair market value of the underlying stock or equity units (as
the case may be) as of the date such option was granted or has
any feature for the deferral of compensation other than the
deferral of recognition of income until the later of exercise or
disposition of such option.
4.15 Compliance With Laws. Public
Company and each of its Subsidiaries has complied with, is not
in violation of, and has not received any notice alleging any
violation with respect to, any applicable provisions of any
statute, law or regulation with respect to the conduct of its
business, or the ownership or operation of its properties or
assets, except for failures to comply or violations that,
individually or in the aggregate, have not had, and are not
reasonably likely to have, a Public Company Material Adverse
Effect.
4.16 Permits and Regulatory Matters.
(a) Public Company and each of its
Subsidiaries have all permits, licenses, registrations,
authorizations and franchises from Governmental Entities
required to conduct their businesses as currently conducted or
as currently proposed to be conducted, including without
limitation all such permits, licenses, registrations,
authorizations and franchises required by the FDA or any other
Governmental Entity exercising comparable authority (the
Public Company Authorizations), except for
such permits, licenses, registrations, authorizations and
franchises the lack of which, individually or in the aggregate,
has not had, and is not reasonably likely to have, a Public
Company Material Adverse Effect. Public Company and its
Subsidiaries are in compliance with the terms of the Public
Company Authorizations, except where the failure to so comply,
individually or in the aggregate, has not had, and is not
reasonably likely to have, a Public Company Material Adverse
Effect. No Public Company Authorization shall cease to be
effective as a result of the consummation of the transactions
contemplated by this Agreement.
(b) All manufacturing, processing,
distribution, labeling, storage, testing, specifications,
sampling, sale or marketing of products performed by or on
behalf of Public Company or any of its Subsidiaries are in
compliance with all applicable laws, rules, regulations or
orders administered or issued by the FDA or any other
Governmental Entity exercising comparable authority, except
where the failure to so comply, individually or in the
aggregate, has not had, and is not reasonably likely to have, a
Public Company Material Adverse Effect. Neither Public Company
nor any of its Subsidiaries has received any notices or
correspondence from the FDA or any other Governmental Entity
exercising comparable authority, and to the knowledge of Public
Company there is no action or proceeding pending or threatened
(including any prosecution, injunction, seizure, civil fine,
suspension or recall), in each case alleging that Public Company
or
A-43
any of its Subsidiaries is not currently in compliance with any
and all applicable laws, regulations or orders implemented by
the FDA or any other Governmental Entity exercising comparable
authority, except where the failure to so comply, individually
or in the aggregate, has not had, and is not reasonably likely
to have, a Public Company Material Adverse Effect.
(c) There are no seizures, recalls,
market withdrawals, field notifications or corrective actions,
notifications of misbranding or adulteration, destruction
orders, safety alerts or similar actions relating to the safety
or efficacy of any products marketed or sold by Public Company
or any of its Subsidiaries being conducted, requested in writing
or, to the knowledge of Public Company, threatened by the FDA or
any other Governmental Entity exercising comparable authority.
Public Company has not, either voluntarily or involuntarily,
initiated, conducted or issued or caused to be initiated,
conducted or issued any recall, market withdrawal, safety alert
or other similar notice or action relating to the alleged lack
of safety or efficacy of any products marketed or sold by Public
Company or any of its Subsidiaries.
(d) The studies, tests and preclinical
and clinical trials conducted by or on behalf of Public Company
or any of its Subsidiaries were and, if still pending, are being
conducted in all material respects in accordance with
experimental protocols, procedures and controls pursuant to,
where applicable, accepted professional and scientific
standards; and neither Public Company nor any of its
Subsidiaries has received any notices or correspondence from the
FDA or any other Governmental Entity exercising comparable
authority requiring the termination, suspension or material
modification of any studies, tests or preclinical or clinical
trials conducted by or on behalf of Public Company or any of its
Subsidiaries, except for such terminations, suspensions or
material modifications that, individually or in the aggregate,
have not had, and are not reasonably likely to have, a Public
Company Material Adverse Effect.
4.17 Employees.
(a) Substantially all current or past key
employees of Public Company or any of its Subsidiaries have
entered into confidentiality and assignment of inventions
agreements with Public Company, a copy or form of which has
previously been provided or made available to Merger Partner. To
the knowledge of Public Company, no employee of Public Company
or any Subsidiary of Public Company is in violation of any term
of any patent disclosure agreement, non-competition agreement,
or any restrictive covenant to a former employer relating to the
right of any such employee to be employed by Public Company or
any of its Subsidiaries because of the nature of the business
currently conducted or currently proposed to be conducted by
Public Company or any of its Subsidiaries or to the use of trade
secrets or proprietary information of others, the consequences
of which, individually or in the aggregate, are reasonably
likely to have a Public Company Material Adverse Effect. To the
knowledge of Public Company, no key employee or group of
employees has any plans to terminate employment with Public
Company or its Subsidiaries.
(b) Neither Public Company nor any of its
Subsidiaries is a party to or otherwise bound by any collective
bargaining agreement, contract or other agreement or
understanding with a labor union or labor organization. Neither
Public Company nor any of its Subsidiaries is the subject of any
proceeding asserting that Public Company or any of its
Subsidiaries has committed an unfair labor practice or is
seeking to compel it to bargain with any labor union or labor
organization that, individually or in the aggregate, is
reasonably likely to have a Public Company Material Adverse
Effect, nor is there pending or, to the knowledge of Public
Company, threatened, any labor strike, dispute, walkout, work
stoppage, slow-down or lockout involving Public Company or any
of its Subsidiaries.
4.18 Insurance. Section 4.18
of the Public Company Disclosure Schedule sets forth a complete
and accurate list as of the date of this Agreement of all
insurance policies maintained by Public Company or any of its
Subsidiaries (the Public Company Insurance
Policies). Each Public Company Insurance Policy is in
full force and effect as of the date of this Agreement. As of
the date of this Agreement, there is no material claim by Public
Company or any of its Subsidiaries pending under any Public
Company Insurance Policy as to which coverage has been
questioned, denied or disputed by the underwriters of such
policy.
A-44
4.19 No Existing Discussions. As of
the date of this Agreement, neither Public Company nor any of
its Subsidiaries is engaged, directly or indirectly, in any
discussions or negotiations with any other party with respect to
an Acquisition Proposal.
4.20 Opinion of Financial
Advisor. The financial advisor of Public Company,
Lazard Freres & Co. LLC (Lazard),
has delivered to the Public Company Board an opinion dated the
date of this Agreement to the effect that, as of such date, the
Exchange Ratio is fair, from a financial point of view, to
Public Company, a signed copy of which opinion will be delivered
to Merger Partner solely for informational purposes promptly
after receipt thereof by Public Company.
4.21 Section 203 of the DGCL Not
Applicable. The Public Company Board has taken
all actions so that the restrictions contained in
Section 203 of the DGCL applicable to a business
combination (as defined in Section 203) shall
not apply to the execution, delivery or performance of this
Agreement, the Public Company Stockholder Agreements or the
consummation of the Merger or the other transactions
contemplated by this Agreement or the Public Company Stockholder
Agreements.
4.22 Brokers; Fees and Expenses. No
agent, broker, investment banker, financial advisor or other
firm or person is or shall be entitled, as a result of any
action, agreement or commitment of Public Company or any of its
Affiliates, to any brokers, finders, financial
advisors or other similar fee or commission in connection
with any of the transactions contemplated by this Agreement,
except Lazard, whose fees and expenses shall be paid by Public
Company. Public Company has provided or made available to Merger
Partner a complete and accurate copy of all agreements pursuant
to which Lazard is entitled to any fees and expenses in
connection with any of the transactions contemplated by this
Agreement.
4.23 Operations of the Transitory
Subsidiary. The Transitory Subsidiary was formed
solely for the purpose of engaging in the transactions
contemplated by this Agreement, has engaged in no other business
activities and has conducted its operations only as contemplated
by this Agreement.
4.24 Controls and Procedures, Certifications and
Other Matters Relating to the Sarbanes Act.
(a) Public Company and each of its
Subsidiaries maintains accurate books and records reflecting its
assets and liabilities and maintains proper and adequate
internal control over financial reporting that provide
reasonable assurance that (i) transactions are executed
with managements authorization, (ii) transactions are
recorded as necessary to permit preparation of the consolidated
financial statements of Public Company and to maintain
accountability for Public Companys consolidated assets,
(iii) access to assets of Public Company and its
Subsidiaries is permitted only in accordance with
managements authorization, (iv) the reporting of
assets of Public Company and its Subsidiaries is compared with
existing assets at regular intervals and (v) accounts,
notes and other receivables and inventory were recorded
accurately, and proper and adequate procedures are implemented
to effect the collection thereof on a current and timely basis.
(b) Public Company maintains disclosure
controls and procedures required by
Rules 13a-15
or 15d-15
under the Exchange Act, and such controls and procedures are
effective to ensure that all material information concerning
Public Company and its Subsidiaries is made known on a timely
basis to the individuals responsible for the preparation of
Public Companys filings with the SEC and other public
disclosure documents.
(c) Neither Public Company nor any of its
officers has received notice from any Governmental Entity
questioning or challenging the accuracy, completeness or manner
of filing or submission of any filing with the SEC, including
without limitation any certifications required by
Section 906 of the Sarbanes Act.
(d) Neither Public Company nor any of its
Subsidiaries has, since Public Company became subject to the
reporting requirements of Section 13 or Section 15(d)
of the Exchange Act, extended or maintained credit, arranged for
the extension of credit, modified or renewed an extension of
credit, in the form of a personal loan or otherwise, to or for
any director or executive officer of Public Company.
Section 4.24(d) of the Public Company Disclosure Schedule
identifies any loan or extension of credit maintained by Public
Company to which the second sentence of Section 13(k)(1) of
the Exchange Act applies.
A-45
ARTICLE V
CONDUCT
OF BUSINESS
5.1 Covenants of Merger
Partner. Except as set forth on Section 5.1
of the Merger Partner Disclosure Schedule or as expressly
provided herein or as consented to in writing by Public Company,
from and after the date of this Agreement until the earlier of
the termination of this Agreement in accordance with its terms
and the Effective Time, Merger Partner shall, and shall cause
each of its Subsidiaries to, act and carry on its business in
the usual, regular and ordinary course in substantially the same
manner as previously conducted, pay its debts and Taxes and
perform its other obligations when due (subject to good faith
disputes over such debts, Taxes or obligations), comply with
applicable laws, rules and regulations, and use commercially
reasonable efforts, consistent with past practices, to maintain
and preserve its and each of its Subsidiaries business
organization, assets and properties, keep available the services
of its present officers and key employees and preserve its
advantageous business relationships with customers, strategic
partners, suppliers, distributors and others having business
dealings with it. Without limiting the generality of the
foregoing, from and after the date of this Agreement until the
earlier of the termination of this Agreement in accordance with
its terms and the Effective Time, Merger Partner shall not, and
shall not permit any of its Subsidiaries to, directly or
indirectly, do any of the following without the prior written
consent of Public Company:
(a) (i) declare, set aside or pay
any dividends on, or make any other distributions (whether in
cash, securities or other property) in respect of, any of its
capital stock (other than dividends and distributions by a
direct or indirect wholly owned Subsidiary of Merger Partner to
its parent); (ii) split, combine or reclassify any of its
capital stock or issue or authorize the issuance of any other
securities in respect of, in lieu of or in substitution for
shares of its capital stock or any of its other securities; or
(iii) purchase, redeem or otherwise acquire any shares of
its capital stock or any other of its securities or any rights,
warrants or options to acquire any such shares or other
securities, other than, in the case of this clause (iii), from
former employees, directors and consultants in accordance with
agreements providing for the repurchase of shares in connection
with any termination of services to Merger Partner or any of its
Subsidiaries;
(b) except as permitted by
Section 5.1(n), issue, deliver, sell, grant, pledge or
otherwise dispose of or encumber any shares of its capital
stock, any other voting securities or any securities convertible
into or exchangeable for, or any rights, warrants or options to
acquire, any such shares, voting securities or convertible or
exchangeable securities (other than the issuance of shares of
Merger Partner Common Stock upon the exercise of Merger Partner
Stock Options or Merger Partner Warrants outstanding on the date
of this Agreement in accordance with their present terms
(including cashless exercises) or Merger Partner Stock Options
granted as contemplated by Section 5.2(n));
(c) amend its certificate of
incorporation, bylaws or other comparable charter or
organizational documents, except as expressly provided by this
Agreement;
(d) except for purchases of inventory in
the Ordinary Course of Business, acquire (i) by merging or
consolidating with, or by purchasing all or a substantial
portion of the assets or any stock of, or by any other manner,
any business or any corporation, partnership, joint venture,
limited liability company, association or other business
organization or division thereof or (ii) any assets that
are material, in the aggregate, to Merger Partner and its
Subsidiaries, taken as a whole;
(e) except in the Ordinary Course of
Business, sell, lease, license, pledge, or otherwise dispose of
or encumber any properties or assets of Merger Partner or of any
of its Subsidiaries;
(f) whether or not in the Ordinary Course
of Business, sell, dispose of or otherwise transfer any assets
material to Merger Partner and its Subsidiaries, taken as a
whole (including any accounts, leases, contracts or intellectual
property or any assets or the stock of any of its Subsidiaries,
but excluding the sale or license of products in the Ordinary
Course of Business);
(g) adopt or implement any stockholder
rights plan;
A-46
(h) enter into an agreement with respect
to any merger, consolidation, liquidation or business
combination, or any acquisition or disposition of all or
substantially all of the assets or securities of Merger Partner
or any of its Subsidiaries;
(i) (i) incur or suffer to exist any
indebtedness for borrowed money other than such indebtedness
that existed as of December 31, 2007 as reflected on the
Merger Partner Balance Sheet (provided that this clause (i)
shall not preclude Merger Partner from drawing on its $4,000,000
line of credit with Paragon Commercial Bank in the Ordinary
Course of Business) or guarantee any such indebtedness of
another person, (ii) issue, sell or amend any debt
securities or warrants or other rights to acquire any debt
securities of Merger Partner or any of its Subsidiaries,
guarantee any debt securities of another person, enter into any
keep well or other agreement to maintain any
financial statement condition of another person or enter into
any arrangement having the economic effect of any of the
foregoing, (iii) make any loans, advances (other than
routine advances to employees of Merger Partner in the Ordinary
Course of Business) or capital contributions to, or investment
in, any other person, other than Merger Partner or any of its
direct or indirect wholly owned Subsidiaries or (iv) enter
into any hedging agreement or other financial agreement or
arrangement designed to protect Merger Partner or its
Subsidiaries against fluctuations in commodities prices or
exchange rates;
(j) make any capital expenditures or
other expenditures with respect to property, plant or equipment
in excess of $50,000 in the aggregate for Merger Partner and its
Subsidiaries, taken as a whole;
(k) make any changes in accounting
methods, principles or practices, except insofar as may have
been required by the SEC or a change in GAAP or, except as so
required, change any assumption underlying, or method of
calculating, any bad debt, contingency or other reserve;
(l) modify, amend or terminate any
material contract or agreement to which Merger Partner or any of
its Subsidiaries is party, or knowingly waive, release or assign
any material rights or claims (including any write-off or other
compromise of any accounts receivable of Merger Partner of any
of its Subsidiaries), except in the Ordinary Course of Business
or, to the extent subject to reserves reflected on the Merger
Partner Balance Sheet, in accordance with GAAP;
(m) (i) except in the Ordinary
Course of Business, enter into any material contract or
agreement relating to the rendering of services or the
distribution, sale or marketing by third parties of the products
of, or products licensed by, Merger Partner or any of its
Subsidiaries or (ii) license any material Intellectual
Property to or from any third party;
(n) except as required to comply with
applicable law or agreements, plans or arrangements existing on
the date hereof, (i) take any action with respect to,
adopt, enter into, terminate or amend any employment, severance
or similar agreement or benefit plan for the benefit or welfare
of any current or former director, officer, employee or
consultant or any collective bargaining agreement,
(ii) increase in any material respect the compensation or
fringe benefits of, or pay any bonus to, any director, officer,
employee or consultant (except for annual increases of the
salaries of non-officer employees in the Ordinary Course of
Business), (iii) amend or accelerate the payment, right to
payment or vesting of any compensation or benefits, including
any outstanding Merger Partner Stock Options or restricted stock
awards, (iv) pay any material benefit not provided for as
of the date of this Agreement under any benefit plan,
(v) grant any awards under any bonus, incentive,
performance or other compensation plan or arrangement or benefit
plan (including the grant of stock options, stock appreciation
rights, stock based or stock related awards, performance units
or restricted stock, or the removal of existing restrictions in
any benefit plans or agreements or awards made thereunder),
except for the grant of options to purchase Merger Partner
Common Stock to new hires, which grants shall not exceed
100,000 shares in the aggregate and 5,000 shares to
any one person, and which option grants shall have an exercise
price equal to the fair market value of Merger Partner Common
Stock on the date of grant (determined in a manner consistent
with Merger Partners existing practice for establishing
fair market value for option grants and which option grants
shall otherwise be upon Merger Partners customary terms)
or (vi) take any action other than in the Ordinary Course
of Business to fund or in any other way secure the payment of
compensation or benefits under any employee plan, agreement,
contract or arrangement or benefit plan;
A-47
(o) make or rescind any material Tax
election, settle or compromise any material Tax liability or
amend any Tax return except as required by applicable law;
(p) commence any offering of shares of
Merger Partner Common Stock pursuant to any employee stock
purchase plan, permit any employee to enroll in any employee
stock purchase plan or allow any participant in an employee
stock purchase plan to increase the current level of such
participants payroll deductions thereunder;
(q) initiate, compromise or settle any
material litigation or arbitration proceeding;
(r) open or close any facility or office;
(s) fail to use commercially reasonable
efforts to maintain insurance at levels substantially comparable
to levels existing as of the date of this Agreement;
(t) fail to pay accounts payable and
other obligations in the Ordinary Course of Business;
(u) fail to use commercially reasonable
efforts to maintain inventory levels in the sales channel to
ensure product availability to meet expected patient demand;
provided, however, that the inventory level of any
individual product in the sales channel shall not exceed
aggregate sales for the preceding three months for such product,
as measured by industry standard third party data sources, such
as IMS Health, National Prescription Audit or the like; or
(v) authorize any of, or commit or agree,
in writing or otherwise, to take any of, the foregoing actions
or any action that would make any representation or warranty of
Merger Partner in this Agreement untrue or incorrect in any
material respect, or would materially impair or prevent the
satisfaction of any conditions in Article VII hereof.
5.2 Covenants of Public
Company. Except as set forth on Section 5.2
of the Public Company Disclosure Schedule or as expressly
provided herein or as consented to in writing by Merger Partner,
from and after the date of this Agreement until the earlier of
the termination of this Agreement in accordance with its terms
and the Effective Time, Public Company shall, and shall cause
each of its Subsidiaries to, act and carry on its business in
the usual, regular and ordinary course in substantially the same
manner as previously conducted, pay its debts and Taxes and
perform its other obligations when due (subject to good faith
disputes over such debts, Taxes or obligations), comply with
applicable laws, rules and regulations, and use commercially
reasonable efforts, consistent with past practices, to maintain
and preserve its and each of its Subsidiaries business
organization, assets and properties, keep available the services
of its present officers and key employees and preserve its
advantageous business relationships with customers, strategic
partners, suppliers, distributors and others having business
dealings with it. Without limiting the generality of the
foregoing, from and after the date of this Agreement until the
earlier of the termination of this Agreement in accordance with
its terms and the Effective Time, Public Company shall not, and
shall not permit any of its Subsidiaries to, directly or
indirectly, do any of the following without the prior written
consent of Merger Partner:
(a) (i) declare, set aside or pay
any dividends on, or make any other distributions (whether in
cash, securities or other property) in respect of, any of its
capital stock (other than dividends and distributions by a
direct or indirect wholly owned Subsidiary of Public Company to
its parent); (ii) with the exception of the Reverse Stock
Split, split, combine or reclassify any of its capital stock or
issue or authorize the issuance of any other securities in
respect of, in lieu of or in substitution for shares of its
capital stock or any of its other securities; or
(iii) purchase, redeem or otherwise acquire any shares of
its capital stock or any other of its securities or any rights,
warrants or options to acquire any such shares or other
securities, other than, in the case of this clause (iii), from
former employees, directors and consultants in accordance with
agreements providing for the repurchase of shares in connection
with any termination of services to Public Company or any of its
Subsidiaries;
(b) except as permitted by
Section 5.2(n), issue, deliver, sell, grant, pledge or
otherwise dispose of or encumber any shares of its capital
stock, any other voting securities or any securities convertible
into or exchangeable for, or any rights, warrants or options to
acquire, any such shares, voting securities or
A-48
convertible or exchangeable securities (other than the issuance
of shares of Public Company Common Stock upon the exercise of
Public Company Stock Options or Public Company Warrants
outstanding on the date of this Agreement in accordance with
their present terms (including cashless exercises) or Public
Company Stock Options granted as contemplated by
Section 5.2(n));
(c) amend its certificate of
incorporation, bylaws or other comparable charter or
organizational documents, except to the extent necessary to
carry into effect the provisions of Section 6.12 or as
otherwise expressly provided by this Agreement;
(d) except for purchases of inventory in
the Ordinary Course of Business, acquire (i) by merging or
consolidating with, or by purchasing all or a substantial
portion of the assets or any stock of, or by any other manner,
any business or any corporation, partnership, joint venture,
limited liability company, association or other business
organization or division thereof or (ii) any assets that
are material, in the aggregate, to Public Company and its
Subsidiaries, taken as a whole;
(e) except in the Ordinary Course of
Business, sell, lease, license, pledge, or otherwise dispose of
or encumber any properties or assets of Public Company or of any
of its Subsidiaries;
(f) whether or not in the Ordinary Course
of Business, sell, dispose of or otherwise transfer any assets
material to Public Company and its Subsidiaries, taken as a
whole (including any accounts, leases, contracts or intellectual
property or any assets or the stock of any of its Subsidiaries,
but excluding the sale or license of products in the Ordinary
Course of Business);
(g) adopt or implement any stockholder
rights plan;
(h) except for a confidentiality
agreement as permitted by Section 6.1, enter into an
agreement with respect to any merger, consolidation, liquidation
or business combination, or any acquisition or disposition of
all or substantially all of the assets or securities of Public
Company or any of its Subsidiaries;
(i) (i) incur or suffer to exist any
indebtedness for borrowed money or guarantee any such
indebtedness of another person, (ii) issue, sell or amend
any debt securities or warrants or other rights to acquire any
debt securities of Public Company or any of its Subsidiaries,
guarantee any debt securities of another person, enter into any
keep well or other agreement to maintain any
financial statement condition of another person or enter into
any arrangement having the economic effect of any of the
foregoing, (iii) make any loans, advances (other than
routine advances to employees of Public Company in the Ordinary
Course of Business) or capital contributions to, or investment
in, any other person, other than Public Company or any of its
direct or indirect wholly owned Subsidiaries or (iv) enter
into any hedging agreement or other financial agreement or
arrangement designed to protect Public Company or its
Subsidiaries against fluctuations in commodities prices or
exchange rates;
(j) make any capital expenditures or
other expenditures with respect to property, plant or equipment
in excess of $50,000 in the aggregate for Public Company and its
Subsidiaries, taken as a whole, other than as set forth in
Public Companys budget for capital expenditures previously
made available to Merger Partner or the specific capital
expenditures disclosed and set forth in Section 4.7 of the
Public Company Disclosure Schedule;
(k) make any changes in accounting
methods, principles or practices, except insofar as may have
been required by the SEC or a change in GAAP or, except as so
required, change any assumption underlying, or method of
calculating, any bad debt, contingency or other reserve;
(l) modify, amend or terminate any
material contract or agreement to which Public Company or any of
its Subsidiaries is party, or knowingly waive, release or assign
any material rights or claims (including any write-off or other
compromise of any accounts receivable of Public Company of any
of its Subsidiaries), except in the Ordinary Course of Business
or, to the extent subject to reserves reflected on the Public
Company Balance Sheet, in accordance with GAAP;
(m) (i) except in the Ordinary
Course of Business, enter into any material contract or
agreement relating to the rendering of services or the
distribution, sale or marketing by third parties of the
A-49
products of, or products licensed by, Public Company or any of
its Subsidiaries or (ii) license any material Intellectual
Property to or from any third party;
(n) except as required to comply with
applicable law or agreements, plans or arrangements existing on
the date hereof, (i) take any action with respect to,
adopt, enter into, terminate or amend any employment, severance
or similar agreement or benefit plan for the benefit or welfare
of any current or former director, officer, employee or
consultant or any collective bargaining agreement,
(ii) increase in any material respect the compensation or
fringe benefits of, or pay any bonus to, any director, officer,
employee or consultant (except for annual increases of the
salaries of non-officer employees in the Ordinary Course of
Business), (iii) amend or accelerate the payment, right to
payment or vesting of any compensation or benefits, including
any outstanding Public Company Stock Options or restricted stock
awards, (iv) pay any material benefit not provided for as
of the date of this Agreement under any benefit plan,
(v) grant any awards under any bonus, incentive,
performance or other compensation plan or arrangement or benefit
plan (including the grant of stock options, stock appreciation
rights, stock based or stock related awards, performance units
or restricted stock, or the removal of existing restrictions in
any benefit plans or agreements or awards made thereunder),
except for the grant of options to purchase Public Company
Common Stock to new hires, which grants shall not exceed
100,000 shares in the aggregate and 5,000 shares to
any one person, and which option grants shall have an exercise
price equal to the fair market value of Public Company Common
Stock on the date of grant (determined in a manner consistent
with Public Companys existing practice for establishing
fair market value for option grants and which option grants
shall otherwise be upon Public Companys customary terms)
or (vi) take any action other than in the Ordinary Course
of Business to fund or in any other way secure the payment of
compensation or benefits under any employee plan, agreement,
contract or arrangement or benefit plan;
(o) make or rescind any material Tax
election, settle or compromise any material Tax liability or
amend any Tax return except as required by applicable law;
(p) commence any offering of shares of
Public Company Common Stock pursuant to any employee stock
purchase plan, permit any employee to enroll in any employee
stock purchase plan or allow any participant in an employee
stock purchase plan to increase the current level of such
participants payroll deductions thereunder;
(q) initiate, compromise or settle any
material litigation or arbitration proceeding;
(r) open or close any facility or office;
(s) fail to use commercially reasonable
efforts to maintain insurance at levels substantially comparable
to levels existing as of the date of this Agreement;
(t) fail to pay accounts payable and
other obligations in the Ordinary Course of Business;
(u) fail to use commercially reasonable
efforts to maintain inventory levels in the sales channel to
ensure product availability to meet expected patient demand;
provided, however, that the inventory level of any
individual product in the sales channel shall not exceed
aggregate sales for the preceding three months for such product,
as measured by industry standard third party data sources, such
as IMS Health, National Prescription Audit or the like;
(v) fail to appropriately adjust any
Public Company Stock Options or Public Company Warrants so that
the exercise prices and number of shares issuable upon exercise
provide the holder the same economic benefit as existed
immediately prior to the Reverse Stock Split; or
(w) authorize any of, or commit or agree,
in writing or otherwise, to take any of, the foregoing actions
or any action that would make any representation or warranty of
Public Company in this Agreement untrue or incorrect in any
material respect, or would materially impair or prevent the
satisfaction of any conditions in Article VII hereof.
A-50
5.3 Confidentiality. The
parties acknowledge that Public Company and Operating Company
have previously executed a confidentiality agreement, dated as
of February 20, 2008 (the Confidentiality
Agreement), which Confidentiality Agreement shall
continue in full force and effect in accordance with its terms,
except as expressly modified by this Agreement. Merger Partner
hereby acknowledges that it is bound by the terms and conditions
of the Confidentiality Agreement to the same extent as if it
were an original party thereto.
ARTICLE VI
ADDITIONAL
AGREEMENTS
6.1 No Solicitation
(a) No Solicitation or
Negotiation. Except as set forth in this
Section 6.1, Merger Partner and Public Company shall not,
nor shall either of them authorize or permit any of their or
their Subsidiaries respective Subsidiaries or any of their
or their Subsidiaries respective directors, officers,
employees, investment bankers, attorneys, accountants or other
advisors or representatives (such directors, officers,
employees, investment bankers, attorneys, accountants, other
advisors and representatives, collectively,
Representatives) to directly or indirectly:
(i) solicit, initiate, encourage or take
any other action designed to facilitate any inquiries or the
making of any proposal or offer that constitutes, or could
reasonably be expected to lead to, any Acquisition Proposal,
including without limitation (A) approving any transaction
under Section 203 of the DGCL, (B) approving any
person becoming an interested stockholder under
Section 203 of the DGCL and (C) amending or granting
any waiver or release under any standstill or similar agreement
with respect to any Merger Partner Common Stock or Public
Company Common Stock, respectively; or
(ii) enter into, continue or otherwise
participate in any discussions or negotiations regarding,
furnish to any person any information with respect to, assist or
participate in any effort or attempt by any person with respect
to, or otherwise cooperate in any way with, any Acquisition
Proposal.
Notwithstanding the foregoing, if at any time prior to the
approval of the issuance of the shares of Public Company Common
Stock in the Merger at the Public Company Meeting (the
Specified Time) Public Company receives a
written Acquisition Proposal from any person or group of persons
that did not result from a breach by Public Company of this
Section 6.1, (A) Public Company may contact such
person or group of persons to clarify the terms and conditions
thereof and (B) if the Public Company Board, or any
committee thereof, determines in good faith, after consultation
with outside legal counsel and a nationally recognized financial
advisor, that such Acquisition Proposal constitutes or could
reasonably be expected to lead to a Superior Proposal, then
Public Company and its Representatives may, subject to
compliance with Section 6.1(c), (x) furnish
information with respect to Public Company to the person making
such Acquisition Proposal and its Representatives pursuant to a
customary confidentiality agreement not less restrictive of the
other party than the Confidentiality Agreement and
(y) participate in discussions or negotiations with such
person and its Representatives regarding any Superior Proposal.
Without limiting the foregoing, it is agreed that any violation
of the restrictions set forth in this Section 6.1(a) or the
taking of any actions inconsistent with the restrictions set
forth in this Section 6.1(a) by any Representative of
Public Company or any of its Subsidiaries, whether or not such
person is purporting to act on behalf of Public Company or
otherwise, shall be deemed to be a breach of this
Section 6.1(a) by Public Company.
(b) No Change in Recommendation or
Alternative Acquisition Agreement. Neither the
Merger Partner Board nor the Public Company Board nor any
committee thereof shall:
(i) except as set forth in this
Section 6.1, withdraw or modify, or publicly (or in a
manner designed to become public) propose to withdraw or modify,
in a manner adverse to the other party, its approval or
recommendation with respect to the Merger Partner Voting
Proposal or the Public Company Voting Proposals, as the case may
be;
A-51
(ii) cause or permit Merger Partner or
Public Company to enter into any letter of intent, memorandum of
understanding, agreement in principle, acquisition agreement,
merger agreement or similar agreement constituting or relating
to any Acquisition Proposal (other than, with respect to Public
Company, a confidentiality agreement referred to in
Section 6.1(a) entered into in the circumstances referred
to in Section 6.1(a)); or
(iii) adopt, approve or recommend, or
propose to adopt, approve or recommend, any Acquisition Proposal.
Notwithstanding the foregoing, the Public Company Board may
withdraw or modify its recommendation with respect to the Public
Company Voting Proposals if the Public Company Board determines
in good faith after consultation with outside counsel that its
fiduciary obligations require it to do so, but only at a time
that is prior to the Specified Time and after the fifth business
day following receipt by Merger Partner of written notice
advising it that the Public Company Board desires to withdraw or
modify the recommendation and, if such withdrawal is due to the
existence of an Acquisition Proposal, specifying the material
terms and conditions of such Acquisition Proposal and
identifying the person making such Acquisition Proposal. Nothing
in this Section 6.1 shall be deemed to (A) permit
Public Company to take any action described in clauses (ii)
or (iii) of the first sentence of this Section 6.1(b),
(B) affect any obligation of Public Company under this
Agreement or (C) limit Public Companys obligation to
call, give notice of, convene and hold the Public Company
Meeting, regardless of whether the Public Company Board has
withdrawn or modified its recommendation.
(c) Notices; Additional
Negotiations. Each party shall immediately advise
the other party orally, with written confirmation to follow
promptly (and in any event within 24 hours), of any
Acquisition Proposal or any request for nonpublic information in
connection with any Acquisition Proposal, or of any inquiry with
respect to, or that could reasonably be expected to lead to, any
Acquisition Proposal, the material terms and conditions of any
such Acquisition Proposal or inquiry and the identity of the
person making any such Acquisition Proposal or inquiry. Public
Company shall not provide any information to or participate in
discussions or negotiations with the person or entity making any
Superior Proposal until five business days after it has first
notified Merger Partner of such Acquisition Proposal as required
by the preceding sentence. Merger Partner shall not provide any
information to or participate in discussions or negotiations
with any such person or entity under any circumstances. Public
Company shall (i) keep Merger Partner fully informed, on a
current basis, of the status and details (including any change
to the terms) of any such Acquisition Proposal or inquiry,
(ii) provide to Merger Partner as soon as practicable after
receipt or delivery thereof copies of all correspondence and
other written material sent or provided Public Company from any
third party in connection with any Acquisition Proposal or sent
or provided by Public Company to any third party in connection
with any Superior Proposal, and (iii) if Merger Partner
shall make a counterproposal, consider and cause its financial
and legal advisors to negotiate on its behalf in good faith with
respect to the terms of such counterproposal. Contemporaneously
with providing any information to a third party in connection
with any such Superior Proposal or inquiry, Public Company shall
furnish a copy of such information to Merger Partner.
(d) Certain Permitted
Disclosure. Nothing contained in this
Section 6.1 or in Section 6.5 shall be deemed to
prohibit either party from taking and disclosing to its
stockholders a position with respect to a tender offer
contemplated by
Rule 14e-2(a)
promulgated under the Exchange Act if, in the good faith
judgment of the Merger Partner Board or the Public Company
Board, as the case may be, after consultation with outside
counsel, failure to so disclose would be inconsistent with its
obligations under applicable law.
(e) Cessation of Ongoing
Discussions. Each party shall, and shall cause
its Subsidiaries and its and their Representatives to, cease
immediately all discussions and negotiations regarding any
proposal that constitutes, or could reasonably be expected to
lead to, an Acquisition Proposal.
A-52
(f) Definitions. For
purposes of this Agreement, the following terms shall have the
following meanings:
Acquisition Proposal means, with respect to
any party hereto, any inquiry, proposal or offer from any person
relating to, in a single transaction or series of related
transactions, any (i) acquisition of assets of such party
and its Subsidiaries (including securities of Subsidiaries, but
excluding sales of assets in the Ordinary Course of Business)
equal to 10% or more of such partys consolidated assets or
to which 10% or more of such partys revenues or earnings
on a consolidated basis are attributable, (ii) acquisition
of 10% or more of such partys outstanding common stock,
(iii) tender offer or exchange offer that if consummated
would result in any person beneficially owning 10% or more of
such partys outstanding common stock, (iv) merger,
consolidation, share exchange, business combination,
recapitalization, liquidation, dissolution or similar
transaction involving such party or any of its Subsidiaries or
(v) any combination of the foregoing types of transactions
if the sum of the percentage of consolidated assets,
consolidated revenues or earnings and common stock involved is
10% or more, in each case, other than the Merger contemplated by
this Agreement.
Superior Proposal means, with respect to
Public Company, any unsolicited, bona fide written Acquisition
Proposal on terms that the Public Company Board determines in
its good faith judgment to be (i) materially more favorable
to the stockholders of Public Company than the transactions
contemplated by this Agreement, taking into account all the
terms and conditions of such proposal (including the likelihood
and timing of consummation thereof) and this Agreement
(including any written proposal by either party to amend the
terms of this Agreement in response to such Acquisition Proposal
or otherwise) and after consultation with outside legal counsel
and a nationally recognized financial advisor, and
(ii) reasonably capable of being completed on the terms
proposed, taking into account all financial, regulatory, legal
and other aspects of such proposal; provided,
however, that no Acquisition Proposal shall be deemed to
be a Superior Proposal if any financing required to consummate
the Acquisition Proposal is not fully and irrevocably committed;
and provided, further, that for purposes of the
definition of Superior Proposal, the references to
10% in the definition of Acquisition Proposal shall
be deemed to be references to 50%.
6.2 Proxy Statement/Prospectus;
Registration Statement.
(a) As promptly as practical after the
execution of this Agreement, Public Company, in cooperation with
Merger Partner, shall prepare and file with the SEC the
Registration Statement, in which the Proxy Statement/Prospectus
will be included as a prospectus. Merger Partner shall use
commercially reasonable efforts to cause the timely cooperation
of its independent public accountants in connection with the
preparation and filing of the Proxy Statement/Prospectus. Each
of Public Company and Merger Partner shall respond to any
comments of the SEC and shall use its respective commercially
reasonable efforts to have the Registration Statement declared
effective under the Securities Act as promptly as practicable
after such filings, and Public Company and Merger Partner shall
cause the Proxy Statement/Prospectus to be mailed to their
respective stockholders at the earliest practicable time after
the Registration Statement is declared effective under the
Securities Act. Each of Public Company and Merger Partner shall
notify the other promptly upon the receipt of any comments from
the SEC or its staff or any other government officials and of
any request by the SEC or its staff or any other government
officials for amendments or supplements to the Registration
Statement, the Proxy Statement/Prospectus or any filing pursuant
to Section 6.2(b) or for additional information and shall
supply the other with copies of all correspondence between such
party or any of its representatives, on the one hand, and the
SEC, or its staff or any other government officials, on the
other hand, with respect to the Registration Statement, the
Proxy Statement/Prospectus, the Merger or any filing pursuant to
Section 6.2(b). Each of Public Company and Merger Partner
shall use commercially reasonable efforts to cause all documents
that it is responsible for filing with the SEC or other
regulatory authorities under this Section 6.2 to comply in
all material respects with all applicable requirements of law
and the rules and regulations promulgated thereunder. Whenever
any event occurs which is required to be set forth in an
amendment or supplement to the Proxy Statement/Prospectus, the
Registration Statement or any filing pursuant to
Section 6.2(b), Public Company or Merger Partner, as the
case may be, shall promptly inform the other of such occurrence
and cooperate in filing with the SEC or its staff or any other
Governmental Entity or government officials,
and/or
mailing to stockholders of Public Company and Merger Partner,
such amendment or supplement. No filing of, or amendment or
supplement to, the Registration Statement or the Proxy
A-53
Statement/Prospectus will be made by Public Company without
providing Merger Partner the opportunity to review and comment
thereon.
(b) Public Company and Merger Partner
shall promptly make all necessary filings with respect to the
Merger under the Securities Act, the Exchange Act, applicable
state blue sky laws and the rules and regulations thereunder.
(c) Public Company and Merger Partner
shall include in the Proxy Statement/Prospectus such information
as Merger Partner reasonably determines is required to be
provided to its stockholders under Section 262 of the DGCL,
including, without limitation, a copy of Section 262 of the
DGCL and language to the effect that the Proxy
Statement/Prospectus constitutes notice concerning the
availability of appraisal rights under Section 262 of the
DGCL.
6.3 NASDAQ
Listing. Public Company agrees to use its
commercially reasonable efforts to continue the listing of
Public Company Common Stock on the NASDAQ Global Market during
the term of this Agreement. Public Company, in consultation with
Merger Partner, shall file (i) an application for initial
inclusion on the NASDAQ Global Market or, if appropriate, the
NASDAQ Capital Market in connection with the re-listing of the
Public Company Common Stock pursuant to NASDAQ Marketplace
Rule 4340 at an appropriate time mutually agreed upon by
Public Company and Merger Partner and (ii) a Notification
Form: Listing of Additional Shares with respect to the shares of
Public Company Common Stock issuable in connection with the
Merger or upon exercise of Merger Partner Stock Options or
Merger Partner Warrants no later than 15 days prior to the
Closing Date.
6.4 Access to
Information. Each of Public Company and Merger
Partner shall (and shall cause each of its Subsidiaries to)
afford to the other partys officers, employees,
accountants, counsel and other representatives, reasonable
access, during normal business hours during the period prior to
the Effective Time, to all its properties, books, contracts,
commitments, personnel and records and, during such period, each
of Public Company and Merger Partner shall (and shall cause each
of its Subsidiaries to) furnish promptly to the other party
(a) a copy of each report, schedule, registration statement
and other document filed or received by it during such period
pursuant to the requirements of federal or state securities laws
and (b) all other information concerning its business,
properties, assets and personnel as the other party may
reasonably request. Each of Public Company and Merger Partner
will hold any such information which is nonpublic in confidence
in accordance with the Confidentiality Agreement. No information
or knowledge obtained in any investigation pursuant to this
Section 6.4 or otherwise shall affect or be deemed to
modify any representation or warranty contained in this
Agreement or the conditions to the obligations of the parties to
consummate the Merger.
6.5 Stockholder Approval.
(a) On or before 5:00 p.m., New York
City time, on the first business day after execution of this
Agreement, Merger Partner shall seek the Merger Partner
Stockholder Approval by the Written Consents to be executed and
delivered by Merger Partners stockholders evidencing the
adoption of this Agreement and the approval of the Merger. In
connection with the Merger Partner Stockholder Approval, Merger
Partner shall comply with all disclosure and other obligations
to its stockholders under the DGCL and any other applicable
laws. Without limiting the generality of the foregoing, Merger
Partner agrees that its obligations under this
Section 6.5(a) shall not be affected by the commencement,
public proposal, public disclosure or communication to Merger
Partner of any Acquisition Proposal. Within five business days
after the date of the Merger Partner Stockholder Approval,
Merger Partner shall send, pursuant to Section 228 of the
DGCL, a written notice to all of its stockholders that did not
execute a Written Consent informing them that this Agreement and
the Merger were adopted and approved by the stockholders of
Merger Partner and that Merger Partner will provide such
stockholders information at a later date regarding their
Appraisal Rights. Any solicitation or similar disclosure
circulated to Merger Partners stockholders shall be in
form and substance reasonably satisfactory to Public Company
and, if the Merger Partner Stockholder Approval has not already
been obtained, shall include the recommendation of the Merger
Partner Board that Merger Partners stockholders vote in
favor of adoption of this Agreement and approval of the Merger.
Notwithstanding the foregoing, nothing herein shall limit a
partys right to terminate this Agreement pursuant to
Section 8.1.
A-54
(b) Public Company, acting through the
Public Company Board, shall take all actions in accordance with
applicable law, its Certificate of Incorporation and Bylaws and
NASDAQ rules promptly and duly to call, give notice of, convene
and hold as promptly as practicable after the declaration of
effectiveness of the Registration Statement, the Public Company
Meeting for the purpose of considering and voting upon the
Public Company Voting Proposals. Subject to Section 6.1(b),
to the fullest extent permitted by applicable law, (i) the
Public Company Board shall recommend approval of the Public
Company Voting Proposals by the stockholders of Public Company
and include such recommendation in the Proxy
Statement/Prospectus, and (ii) neither Public Company Board
nor any committee thereof shall withdraw or modify, or propose
or resolve to withdraw or modify in a manner adverse to Merger
Partner, the recommendation of the Public Company Board that
Public Companys stockholders vote in favor of the Public
Company Voting Proposals. Public Company shall take all action
that is both reasonable and lawful (including the retention of a
professional proxy solicitation firm, the scope and types of
services of which shall be mutually agreed upon by the parties
with a view towards securing stockholder approval of the Public
Company Voting Proposals) to solicit from its stockholders
proxies in favor of the Public Company Voting Proposals and
shall take all other action necessary or advisable to secure the
vote or consent of the stockholders of Public Company required
by NASDAQ rules and the DGCL, as applicable, to obtain such
approvals. Notwithstanding anything to the contrary contained in
this Agreement, Public Company, after consultation with Merger
Partner, may adjourn or postpone the Public Company Meeting to
the extent necessary to ensure that any required supplement or
amendment to the Proxy Statement/Prospectus is provided to
Public Companys stockholders or, if as of the time for
which the Public Company Meeting is originally scheduled (as set
forth in the Proxy Statement/Prospectus) there are insufficient
shares of Public Company Common Stock represented (either in
person or by proxy) to constitute a quorum necessary to conduct
the business of the Public Company Meeting.
(c) Public Company shall call, give
notice of, convene and hold the Public Company Meeting in
accordance with this Section 6.5, and shall submit the
Public Company Voting Proposals to its stockholders for the
purpose of acting upon such proposal whether or not (i) the
Public Company Board at any time subsequent to the date hereof
determines, in the manner permitted by Section 6.1(b), that
this Agreement is no longer advisable or recommends that the
stockholders of Public Company reject such proposal, or
(ii) any actual, potential or purported Acquisition
Proposal or Superior Proposal has been commenced, disclosed,
announced or submitted to Public Company.
6.6 Legal Conditions to Merger.
(a) Subject to the terms hereof,
including Section 6.6(b), Merger Partner and Public Company
shall each use commercially reasonable efforts to (i) take,
or cause to be taken, all actions, and do, or cause to be done,
and to assist and cooperate with the other parties in doing, all
things necessary, proper or advisable to consummate and make
effective the transactions contemplated hereby as promptly as
practicable, (ii) as promptly as practicable, obtain from
any Governmental Entity or any other third party any consents,
licenses, permits, waivers, approvals, authorizations, or orders
required to be obtained or made by Merger Partner or Public
Company or any of their Subsidiaries in connection with the
authorization, execution and delivery of this Agreement and the
consummation of the transactions contemplated hereby,
(iii) as promptly as practicable, make all necessary
filings, and thereafter make any other required submissions,
with respect to this Agreement and the Merger required under
(A) the Securities Act and the Exchange Act, and any other
applicable federal or state securities laws, (B) the
Hart-Scott-Rodino
Antitrust Improvements Act of 1976, as amended (the HSR
Act), and any related governmental request thereunder
and (C) any other applicable law and (iv) execute or
deliver any additional instruments necessary to consummate the
transactions contemplated by, and to fully carry out the
purposes of, this Agreement. Merger Partner and Public Company
shall cooperate with each other in connection with the making of
all such filings, including providing copies of all such
documents to the non-filing party and its advisors prior to
filing and, if requested, accepting all reasonable additions,
deletions or changes suggested in connection therewith. Merger
Partner and Public Company shall use their respective
commercially reasonable efforts to furnish to each other all
information required for any application or other filing to be
made pursuant to the rules and regulations of any applicable law
(including all information required to be included in the Proxy
Statement/Prospectus and the Registration Statement) in
connection with the transactions contemplated by this Agreement.
For the avoidance of doubt,
A-55
Public Company and Merger Partner agree that nothing contained
in this Section 6.6(a) shall modify or affect their
respective rights and responsibilities under Section 6.6(b).
(b) Subject to the terms hereof, Public
Company and Merger Partner agree, and shall cause each of their
respective Subsidiaries, to cooperate and to use their
respective commercially reasonable efforts to obtain any
government clearances or approvals required for Closing under
the HSR Act, the Sherman Act, as amended, the Clayton Act, as
amended, the Federal Trade Commission Act, as amended, and any
other federal, state or foreign law or, regulation or decree
designed to prohibit, restrict or regulate actions for the
purpose or effect of monopolization or restraint of trade
(collectively, Antitrust Laws), to respond to
any government requests for information under any Antitrust Law,
and to contest and resist any action, including any legislative,
administrative or judicial action, and to have vacated, lifted,
reversed or overturned any decree, judgment, injunction or other
order (whether temporary, preliminary or permanent) that
restricts, prevents or prohibits the consummation of the Merger
or any other transactions contemplated by this Agreement under
any Antitrust Law. The parties hereto will consult and cooperate
with one another, and consider in good faith the views of one
another, in connection with any analyses, appearances,
presentations, memoranda, briefs, arguments, opinions and
proposals made or submitted by or on behalf of any party hereto
in connection with proceedings under or relating to any
Antitrust Law. Public Company shall be entitled to direct any
proceedings or negotiations with any Governmental Entity
relating to any of the foregoing, provided that it shall afford
Merger Partner a reasonable opportunity to participate therein.
Notwithstanding anything to the contrary in this
Section 6.6, neither Public Company nor any of its
Subsidiaries shall be under any obligation to (i) make
proposals, execute or carry out agreements or submit to orders
providing for the sale or other disposition or holding separate
(through the establishment of a trust or otherwise) of any
material assets or categories of assets of Public Company, any
of its Affiliates or Merger Partner or any of its Subsidiaries
or the holding separate of the shares of Merger Partner Common
Stock (or shares of stock of the Surviving Corporation) or
imposing or seeking to impose any material limitation on the
ability of Public Company or any of its subsidiaries or
Affiliates to conduct their business or own such assets or to
acquire, hold or exercise full rights of ownership of the shares
of Merger Partner Common Stock (or shares of stock of the
Surviving Corporation) or (ii) take any action under this
Section 6.6 if the United States Department of Justice or
the United States Federal Trade Commission authorizes its staff
to seek a preliminary injunction or restraining order to enjoin
consummation of the Merger.
(c) Each of Merger Partner and Public
Company shall give (or shall cause their respective Subsidiaries
to give) any notices to third parties, and use, and cause their
respective Subsidiaries to use, their commercially reasonable
efforts to obtain any third party consents related to or
required in connection with the Merger that are
(i) necessary to consummate the transactions contemplated
hereby, (ii) disclosed or required to be disclosed in
Merger Partner Disclosure Schedule or Public Company Disclosure
Schedule, as the case may be or (iii) required to prevent
the occurrence of an event that may have a Merger Partner
Material Adverse Effect or a Public Company Material Adverse
Effect from occurring prior to or after the Effective Time.
6.7 Public
Disclosure. Except as may be required by law or
stock market regulations, (i) the press release announcing
the execution of this Agreement shall be issued only in such
form as shall be mutually agreed upon by Public Company and
Merger Partner, (ii) Public Company shall use commercially
reasonable efforts to consult with Merger Partner before issuing
any press release or otherwise making any public statement with
respect to the Merger or this Agreement and shall not issue any
such press release or make any such public statement prior to
using such efforts and (iii) Merger Partner shall not issue
any press release or otherwise make any public statement with
respect to the Merger or this Agreement without the prior
written consent of Public Company, which shall not be
unreasonably withheld.
6.8 Section 368(a)
Reorganization. Each of Public Company,
Transitory Subsidiary and Merger Partner shall use commercially
reasonable efforts to cause the Merger to qualify, and agree not
to take any action which to its knowledge could reasonably be
expected to cause the merger to fail to qualify, as a
reorganization within the meaning of Section 368(a) of the
Code. This Agreement is intended to constitute, and the parties
hereto hereby adopt this Agreement as, a plan of
reorganization within the meaning of Treasury
Regulation Sections 1.368-2(g)
and 1.368-3(a). Each of Public Company, Transitory Subsidiary
and
A-56
Merger Partner shall report the merger as a reorganization
within the meaning of Section 368(a) of the Code unless
otherwise required pursuant to a determination
within the meaning of Section 1313(a) of the Code.
6.9 D&O Insurance;
Indemnification.
(a) For a period of six years after the
Effective Time, Public Company shall maintain in effect the
current level and scope of directors and officers
liability insurance as in effect immediately prior to the
Effective Time (a copy of which has heretofore been delivered to
Merger Partner) covering those persons who are covered by Public
Companys directors and officers liability
insurance policy immediately prior to the Effective Time;
provided, however, that if the aggregate annual
premiums for such insurance at any time during such period
exceed 150% of the per annum rate of premium currently paid by
Public Company for such insurance on the date hereof, then
Public Company will provide the maximum coverage that will then
be available at an annual premium equal to 150% of such rate.
Notwithstanding the foregoing, Public Company may satisfy its
obligations under this Section 6.9(a) by procuring an
equivalent six-year tail policy under Public
Companys existing directors and officers
liability insurance policy, the equivalent annual premium for
which tail policy shall not exceed 150% of the per
annum rate of premium currently paid by Public Company for
directors and officers liability insurance;
provided that if the equivalent annual premium for such
tail policy exceeds 150% of the per annum rate of
premium currently paid by Public Company for directors and
officers liability insurance, then Public Company will
provide the maximum coverage that will then be available at an
equivalent annual premium equal to 150% of such rate and in
doing so will be deemed to have satisfied its obligations
pursuant to this Section 6.9(a).
(b) For a period of six years after the
Effective Time, Public Company shall, to the fullest extent
permitted by law indemnify and hold harmless each present and
former director and officer of Public Company or any of its
Subsidiaries (the Indemnified Parties),
against any costs or expenses (including attorneys fees),
judgments, fines, losses, claims, damages, liabilities or
amounts paid in settlement incurred in connection with any
claim, action, suit, proceeding or investigation, whether civil,
criminal, administrative or investigative, arising out of or
pertaining to matters existing or occurring at or prior to the
Effective Time, whether asserted or claimed prior to, at or
after the Effective Time, to the fullest extent that Public
Company or one of its Subsidiaries, as the case may be, would
have been permitted under Delaware law and its Certificate of
Incorporation or Bylaws in effect on the date of this Agreement
to indemnify an Indemnified Party (and Public Company shall also
advance expenses as incurred to the fullest extent permitted
under applicable law, provided the Indemnified Party to whom
expenses are advanced provides an undertaking to repay such
advances if it is ultimately determined that such Indemnified
Party is not entitled to indemnification).
(c) If Public Company or any of its
successors or assigns (i) consolidates with or merges into
any other person and shall not be the continuing or surviving
corporation or entity of such consolidation or merger or
(ii) transfers all or substantially all of its properties
and assets to any person, then, and in each such case, proper
provision shall be made so that the successors and assigns of
Public Company shall assume the obligations set forth in this
Section 6.9.
(d) The obligations of Public Company
under this Section 6.9 shall survive the consummation of
the Merger and shall not be terminated or modified in such a
manner as to adversely affect any Indemnified Party to whom this
Section 6.9 applies without the written consent of such
affected Indemnified Party. Public Company shall pay all
expenses, including reasonable attorneys fees, that may be
incurred by any Indemnified Party in connection with enforcement
of such persons rights provided in this Section 6.9.
(e) The provisions of this
Section 6.9 are intended to be in addition to the rights
otherwise available to the officers and directors of Public
Company and its Subsidiaries by law, charter, statute, bylaw or
agreement, and shall operate for the benefit of, and shall be
enforceable by, each of the Indemnified Parties, their heirs and
their representatives as third party beneficiaries.
6.10 Notification of Certain
Matters. Public Company shall give prompt notice
to Merger Partner, and Merger Partner shall give prompt notice
to Public Company, of the occurrence, or failure to occur,
A-57
of any event, which occurrence or failure to occur would be
reasonably likely to cause (a) (i) any representation or
warranty of such party contained in this Agreement that is
qualified as to materiality to be untrue or inaccurate in any
respect or (ii) any other representation or warranty of
such party contained in this Agreement to be untrue or
inaccurate in any material respect, in each case, at any time
from and after the date of this Agreement until the Effective
Time, or (b) any material failure of Public Company and the
Transitory Subsidiary or Merger Partner, as the case may be, or
of any officer, director, employee or agent thereof, to comply
with or satisfy any covenant, condition or agreement to be
complied with or satisfied by it under this Agreement.
Notwithstanding the above, the delivery of any notice pursuant
to this Section 6.10 will not limit or otherwise affect the
remedies available hereunder to the party receiving such notice
or the conditions to such partys obligation to consummate
the Merger.
6.11 Headquarters of Public
Company. Immediately following the Effective
Time, the headquarters of Public Company shall be located at
Merger Partners headquarters.
6.12 Corporate
Identity. Immediately following the Effective
Time, the corporate name of Public Company shall be
Cornerstone Therapeutics Inc.
6.13 Succession. Promptly
after the Effective Time, Public Company shall take all action
necessary to cause the persons identified on
Schedule 6.13 hereto to be appointed as executive
officers of Public Company.
6.14 Board of Directors of Public
Company. Promptly after the Effective Time,
Public Company shall take all action necessary (including,
without limitation, increasing or decreasing the size of the
Board of Directors) to (a) cause to be appointed to the
Public Company Board (i) the persons identified on
Schedule 6.14(a) hereto (unless prohibited by
applicable NASDAQ listing requirements or SEC regulations) and
(ii) such other directors as Public Company and Merger
Partner mutually agree are required to comply with applicable
NASDAQ listing requirements and SEC regulations and
(b) obtain the resignations of the directors identified on
Schedule 6.14(b) hereto effective at the time of
such appointment.
6.15 Employee
Communications. Public Company and Merger Partner
will use reasonable efforts to consult with each other, and will
consider in good faith each others advice, prior to
sending any notices or other communication materials to its
employees regarding this Agreement, the Merger or the effects
thereof on the employment, compensation or benefits of its
employees.
6.16 FIRPTA Tax
Certificates. On or prior to the Closing, Merger
Partner shall deliver to Public Company a certificate that the
Merger Partner Common Stock is not a U.S. real
property interest in accordance with the Treasury
Regulations under Sections 897 and 1445 of the Code,
together with evidence reasonably satisfactory to Public Company
that Merger Partner delivered notice to the Internal Revenue
Service in accordance with the provisions of
Section 1.897-2(h)(2)
of the Treasury Regulations. If Public Company does not receive
the certificate described above on or before the Closing Date,
Public Company shall be permitted to withhold from the payments
to be made pursuant to this Agreement any required withholding
tax under Section 1445 of the Code.
ARTICLE VII
CONDITIONS
TO MERGER
7.1 Conditions to Each Partys
Obligation To Effect the Merger. The respective
obligations of each party to this Agreement to effect the Merger
shall be subject to the satisfaction prior to the Closing Date
of the following conditions:
(a) Stockholder
Approvals. The Merger Partner Voting Proposal
shall have been approved by means of the Written Consents by the
requisite vote of the stockholders of Merger Partner under
applicable law and Merger Partners Certificate of
Incorporation. The Public Company Voting Proposals shall have
been approved at the Public Company Meeting, at which a quorum
is present, by the requisite vote of the stockholders of Public
Company under applicable law and stock market regulations.
A-58
(b) HSR Act. The
waiting period (and any extensions thereof) applicable to the
consummation of the Merger under the HSR Act and any other
applicable law shall have expired or been terminated.
(c) Governmental
Approvals. Other than the filing of the
Certificate of Merger, all authorizations, consents, orders or
approvals of, or declarations or filings with, or expirations of
waiting periods imposed by, any Governmental Entity in
connection with the Merger and the consummation of the other
transactions contemplated by this Agreement, the failure of
which to file, obtain or occur is reasonably likely to have a
Public Company Material Adverse Effect or a Merger Partner
Material Adverse Effect shall have been filed, been obtained or
occurred on terms and conditions that could not reasonably be
likely to have a Public Company Material Adverse Effect or a
Merger Partner Material Adverse Effect.
(d) Registration Statement; Proxy
Statement/Prospectus. The Registration Statement
shall have become effective under the Securities Act and no stop
order suspending the effectiveness of the Registration Statement
shall have been issued and no proceeding for that purpose, and
no similar proceeding with respect to the Proxy
Statement/Prospectus, shall have been initiated or threatened in
writing by the SEC or its staff.
(e) No Injunctions. No
Governmental Entity of competent jurisdiction shall have
enacted, issued, promulgated, enforced or entered any order,
executive order, stay, decree, judgment or injunction
(preliminary or permanent) or statute, rule or regulation which
is in effect and which has the effect of making the Merger
illegal or otherwise prohibiting consummation of the Merger or
the other transactions contemplated by this Agreement.
(f) No
Restraints. There shall not be instituted or
pending any action or proceeding by any Governmental Entity
(i) seeking to restrain, prohibit or otherwise interfere
with the ownership or operation by Public Company or any of its
Subsidiaries of all or any portion of the business of Merger
Partner or any of its Subsidiaries or of Public Company or any
of its Subsidiaries or to compel Public Company or any of its
Subsidiaries to dispose of or hold separate all or any portion
of the business or assets of Merger Partner or any of its
Subsidiaries or of Public Company or any of its Subsidiaries,
(ii) seeking to impose or confirm limitations on the
ability of Public Company or any of its Subsidiaries effectively
to exercise full rights of ownership of the shares of Merger
Partner Common Stock (or shares of stock of the Surviving
Corporation) including the right to vote any such shares on any
matters properly presented to stockholders or (iii) seeking
to require divestiture by Public Company or any of its
Subsidiaries of any such shares.
7.2 Additional Conditions to the
Obligations of Public Company and the Transitory
Subsidiary. The obligations of Public Company and
the Transitory Subsidiary to effect the Merger shall be subject
to the satisfaction on or prior to the Closing Date of each of
the following additional conditions, any of which may be waived
in writing exclusively by Public Company and the Transitory
Subsidiary:
(a) Representations and
Warranties. The representations and warranties of
Merger Partner set forth in Sections 3.2(a) and 3.4(d)
shall be true and correct as of the date of this Agreement and
as of the Closing Date, as if made on and as of the Closing Date
(other than such representations and warranties made as of a
specific date, which shall remain true and correct as of such
specific date), and all other representations and warranties of
Merger Partner set forth in this Agreement, without giving
effect to any qualification or limitation as to
materiality or Merger Partner Material Adverse
Effect, shall be true and correct as of the date of this
Agreement and as of the Closing Date, as if made on and as of
the Closing Date (other than such representations and warranties
made as of a specific date, which shall remain true and correct
as of such specific date), except where failure of such other
representations or warranties to be so true and correct,
individually or in the aggregate with all such failures, has not
had and is not reasonably likely to have a Merger Partner
Material Adverse Effect.
(b) Performance of Obligations of
Merger Partner. Merger Partner shall have
performed in all material respects all obligations required to
be performed by it under this Agreement on or prior to the
Closing Date, and Public Company shall have received a
certificate signed on behalf of Merger Partner by the chief
executive officer and the chief financial officer of Merger
Partner to such effect.
A-59
(c) No Merger Partner Material Adverse
Effect. No Merger Partner Material Adverse Effect
shall have occurred since the date of this Agreement and be
continuing.
(d) Tax Opinion. Public
Company shall have received a written opinion from Wilmer Cutler
Pickering Hale and Dorr LLP (WilmerHale),
counsel to Public Company, to the effect that the Merger will be
treated for federal income tax purposes as a reorganization
within the meaning of Section 368(a) of the Code;
provided that if WilmerHale does not render such opinion,
this condition shall nonetheless be deemed satisfied if counsel
to Merger Partner renders such opinion to Public Company (it
being understood and agreed that Public Company and Merger
Partner shall each provide reasonable cooperation, including
making reasonable and customary representations, to WilmerHale
or counsel to Merger Partner, as the case may be, to enable them
to render such opinion and that counsel shall be entitled to
rely on such representations and such assumptions as they deem
appropriate in rendering such opinion).
(e) Third Party
Consents. Merger Partner shall have obtained
(i) all consents and approvals of third parties listed in
Section 7.2(e)(i) of the Merger Partner Disclosure Schedule
and (ii) any other required consent or approval of any
third party (other than a Governmental Entity) the failure of
which to obtain, individually or in the aggregate, is reasonably
likely to have a Merger Partner Material Adverse Effect (it
being understood and agreed that the failure to obtain or effect
any or all of the consents and approvals listed in
Section 7.2(e)(ii) of the Merger Partner Disclosure
Schedule will not be reasonably likely to have a Merger Partner
Material Adverse Effect).
(f) Dissenting
Shares. The number of Dissenting Shares shall not
exceed 5% of the number of outstanding shares of Merger Partner
Common Stock as of the Effective Time.
(g) Exchange or Conversion of Carolina
Note. The Carolina Note shall have been exchanged
or converted into Merger Partner Common Stock in accordance with
the terms of the Merger Partner Noteholder Agreement.
(h) Merger Partner Stockholder
Agreements and Noteholder Agreement. Merger
Partner shall have delivered fully executed copies of the Merger
Partner Stockholder Agreements from the stockholders of Merger
Partner listed on
Schedule A-1
and a fully executed copy of the Merger Partner Noteholder
Agreement from Carolina Pharmaceuticals Bermuda.
(i) Officers
Certificate. Public Company shall have received
an officers certificate duly executed by each of the
President and Chief Executive Officer and the Vice President,
Finance of Merger Partner to the effect that the conditions of
Sections 7.2(a), (b) and (c) have been satisfied.
(j) Actions to Effect the
Transactions. All actions taken by Merger Partner
in connection with the consummation of the transactions
contemplated hereby and all certificates, opinions, instruments
and other documents required to effect the transactions
contemplated hereby will be reasonably satisfactory in form and
substance to Public Company.
7.3 Additional Conditions to the
Obligations of Merger Partner. The obligation of
Merger Partner to effect the Merger shall be subject to the
satisfaction on or prior to the Closing Date of each of the
following additional conditions, any of which may be waived, in
writing, exclusively by Merger Partner:
(a) Representations and
Warranties. The representations and warranties of
Public Company and Transitory Subsidiary set forth in
Sections 4.2(a) and 4.4(d) shall be true and correct as of
the date of this Agreement and as of the Closing Date, as if
made on and as of the Closing Date (other than such
representations and warranties made as of a specific date, which
shall remain true and correct as of such specific date), and all
other representations and warranties of Public Company and
Transitory Subsidiary set forth in this Agreement, without
giving effect to any qualification or limitation as to
materiality or Public Company Material Adverse
Effect, shall be true and correct as of the date of this
Agreement and as of the Closing Date, as if made on and as of
the Closing Date (other than such representations and warranties
made as of a specific date, which shall remain true and correct
as of such specific date), except where failure of such other
representations or warranties to be so true and correct,
individually or in the aggregate with all such failures, has not
had and is not reasonably likely to have a Public Company
Material Adverse Effect.
A-60
(b) Performance of Obligations of
Public Company and Sub. Public Company and the
Transitory Subsidiary shall have performed in all material
respects all obligations required to be performed by them under
this Agreement on or prior to the Closing Date, and Merger
Partner shall have received a certificate signed on behalf of
Public Company by the chief executive officer or the chief
financial officer of Public Company to such effect.
(c) No Public Company Material Adverse
Effect. No Public Company Material Adverse Effect
shall have occurred since the date of this Agreement and be
continuing.
(d) Tax Opinion. Merger
Partner shall have received the opinion of Smith, Anderson,
Blount, Dorsett, Mitchell & Jernigan, L.L.P.
(Merger Partner Counsel), counsel to Merger
Partner, to the effect that the Merger will be treated for
federal income tax purposes as a reorganization within the
meaning of Section 368(a) of the Code; provided that
if Merger Partner Counsel does not render such opinion, this
condition shall nonetheless be deemed satisfied if counsel to
Public Company renders such opinion to Merger Partner (it being
understood and agreed that Public Company and Merger Partner
shall each provide reasonable cooperation, including making
reasonable and customary representations, to Merger Partner
Counsel or counsel to Public Company, as the case may be, to
enable them to render such opinion and that counsel shall be
entitled to rely on such representations and such assumptions as
they deem appropriate in rendering such opinion).
(e) Third Party
Consents. Public Company shall have obtained
(i) all consents and approvals of third parties listed in
Section 7.3(e)(i) of the Public Company Disclosure Schedule
and (ii) any other consent or approval of any third party
(other than a Governmental Entity) the failure of which to
obtain, individually or in the aggregate, is reasonably likely
to have an Public Company Material Adverse Effect (it being
understood and agreed that the failure to obtain or effect any
or all of the consents and approvals listed in
Section 7.3(e)(ii) of the Public Company Disclosure
Schedule will not be reasonably likely to have a Public Company
Material Adverse Effect).
(f) Public Company Stockholder
Agreements. Public Company shall have delivered
fully executed copies of the Public Company Stockholder
Agreements from the stockholders of Public Company listed on
Schedule A-2.
(g) NASDAQ
Notification. NASDAQ shall have approved Public
Companys application for initial inclusion on the NASDAQ
Global Market or the NASDAQ Capital Market, as applicable, in
connection with the re-listing of the Public Company Common
Stock pursuant to NASDAQ Marketplace Rule 4340 and the
listing of shares of Public Company Common Stock issuable in
connection with the Merger or upon exercise of Merger Partner
Stock Options or Merger Partner Warrants.
(h) Availability of Public Company
Product. At least one of Public Companys
products, ZYFLO CR or ZYFLO, shall be available and ready for
purchase by third party wholesalers or retailers at all times
from the date of the Agreement through the Closing Date, other
than during any period that has not exceeded, and, as of the
Closing Date, is not reasonably expected to exceed, 30
consecutive days.
(i) Officers
Certificate. Merger Partner shall have received
an officers certificate duly executed by each of the
President and Chief Executive Officer and the Chief Financial
Officer of Public Company to the effect that the conditions of
Sections 7.3(a), (b) and (c) have been satisfied.
(j) Actions to Effect the
Transactions. All actions taken by Public Company
in connection with the consummation of the transactions
contemplated hereby and all certificates, opinions, instruments
and other documents required to effect the transactions
contemplated hereby will be reasonably satisfactory in form and
substance to Merger Partner.
A-61
ARTICLE VIII
TERMINATION
AND AMENDMENT
8.1 Termination. This
Agreement may be terminated at any time prior to the Effective
Time (with respect to Sections 8.1(b) through 8.1(j), by
written notice by the terminating party to the other party),
whether before or after approval of the Merger by the
stockholders of Merger Partner:
(a) by mutual written consent of Public
Company and Merger Partner;
(b) by either Public Company or Merger
Partner if the Merger shall not have been consummated by
November 30, 2008 (the Outside Date)
(provided that the right to terminate this Agreement under this
Section 8.1(b) shall not be available to any party whose
failure to fulfill any obligation under this Agreement has been
a principal cause of or resulted in the failure of the Merger to
occur on or before the Outside Date);
(c) by either Public Company or Merger
Partner if a Governmental Entity of competent jurisdiction shall
have issued a nonappealable final order, decree or ruling or
taken any other nonappealable final action, in each case having
the effect of permanently restraining, enjoining or otherwise
prohibiting the Merger;
(d) by either Public Company or Merger
Partner if at the Public Company Meeting (including any
adjournment or postponement permitted by this Agreement), at
which a vote on the Public Company Voting Proposals is taken,
the requisite vote of the stockholders of Public Company in
favor of the Public Company Voting Proposals shall not have been
obtained (provided that the right to terminate this Agreement
under this Section 8.1(d) shall not be available
(i) to any party seeking termination if at such time such
party is in breach of or has failed to fulfill its obligations
under this Agreement or (ii) to Public Company, if the
failure to obtain the requisite vote has been caused by a breach
of a Public Company Stockholder Agreement by any party thereto
other than Merger Partner);
(e) by Public Company, if: (i) the
Merger Partner Board shall have failed to give its
recommendation to the approval of the Merger Partner Voting
Proposal or shall have withdrawn or modified its recommendation
of the Merger Partner Voting Proposal; (ii) after the
receipt by Merger Partner of an Acquisition Proposal, Public
Company requests in writing that the Merger Partner Board
reconfirm its recommendation of this Agreement or the Merger and
the Merger Partner Board fails to do so within five business
days after its receipt of Public Companys request;
(iii) the Merger Partner Board (or any committee thereof)
shall have approved or recommended to the stockholders of Merger
Partner an Acquisition Proposal; (iv) a tender offer or
exchange offer for outstanding shares of Merger Partner Common
Stock is commenced (other than by Public Company or an Affiliate
of Public Company), and the Merger Partner Board (or any
committee thereof) recommends that the stockholders of Merger
Partner tender their shares in such tender or exchange offer or,
within 10 business days after the commencement of such tender
offer or exchange offer, the Merger Partner Board fails to
recommend against acceptance of such offer; or (v) Merger
Partner shall have breached its obligations under
Section 6.1 or Section 6.5(a) of this Agreement;
(f) by Merger Partner, if: (i) the
Public Company Board shall have failed to give its
recommendation to the approval of the Public Company Voting
Proposals in the Proxy Statement/Prospectus or shall have
withdrawn or modified its recommendation of the Public Company
Voting Proposals; (ii) after the receipt by Public Company
of an Acquisition Proposal, Merger Partner requests in writing
that the Public Company Board reconfirm its recommendation of
this Agreement or the Merger and the Public Company Board fails
to do so within five business days after its receipt of Merger
Partners request; (iii) the Public Company Board (or
any committee thereof) shall have approved or recommended to the
stockholders of Public Company an Acquisition Proposal;
(iv) a tender offer or exchange offer for outstanding
shares of Public Company Common Stock is commenced (other than
by Merger Partner or an Affiliate of Merger Partner), and the
Public Company Board (or any committee thereof) recommends that
the stockholders of Public Company tender their shares in such
tender or exchange offer or, within 10 business days after the
commencement of such tender offer or exchange offer, the Public
Company Board fails to recommend against acceptance of such
offer; (v) Public Company shall have breached its
obligations under Section 6.1, Section 6.5(b) or
A-62
Section 6.5(c) of this Agreement; or (vi) Public
Company shall have failed to hold the Public Company Meeting and
submit the Public Company Voting Proposals to Public
Companys stockholders by the date which is one business
day prior to the Outside Date;
(g) by Public Company, if there has been
a breach of or failure to perform any representation, warranty,
covenant or agreement set forth in this Agreement (other than
those referred to elsewhere in this Section 8.1) on the
part of Merger Partner, which breach would cause the conditions
set forth in Section 7.2(a) or (b) not to be
satisfied, and such failure or breach with respect to any such
representation, warranty, covenant or agreement cannot be cured
or, if curable, shall continue unremedied for a period of
30 days after Merger Partner has received written notice
from Public Company of the occurrence of such failure or breach
(provided that in no event shall such 30 day period extend
beyond the second business day immediately preceding the Outside
Date), which written notice must be provided promptly following
such time as Public Company obtains actual knowledge of such
failure or breach;
(h) by Merger Partner, if there has been
a breach of or failure to perform any representation, warranty,
covenant or agreement set forth in this Agreement (other than
those referred to elsewhere in this Section 8.1) on the
part of Public Company, which breach would cause the conditions
set forth in Section 7.3(a) or (b) not to be
satisfied, and such failure or breach with respect to any such
representation, warranty, covenant or agreement cannot be cured
or, if curable, shall continue unremedied for a period of
30 days after Public Company has received written notice
from Merger Partner of the occurrence of such failure or breach
(provided that in no event shall such 30 day period extend
beyond the second business day immediately preceding the Outside
Date), which written notice must be provided promptly following
such time as Merger Partner obtains actual knowledge of such
failure or breach;
(i) by Public Company, if the Merger
Partner Stockholder Approval is not obtained by delivery of the
Written Consents by 5:00 p.m., New York City time, on the
first business day after execution of this Agreement;
provided, however, that Public Company shall not
have any right to terminate this Agreement under this
Section 8.1(i) at any time after the Merger Partner
Stockholder Approval shall have been obtained and written notice
thereof shall have been provided to Public Company; or
(j) by Public Company, if (i) within
15 business days following the date of this Agreement Merger
Partner has not engaged the New Merger Partner Audit Firm
pursuant to a definitive and customary written agreement,
(ii) by August 31, 2008 the New Merger Partner Audit
Firm has not completed an audit and delivered its related
opinion with respect to the consolidated balance sheets and
statements of income, changes in stockholders equity and
cash flows of Merger Partner as of the end of and for each of
last three fiscal years and a review in accordance with
Statement on Auditing Standards No. 100 of the unaudited
consolidated balance sheets and statements of income and cash
flows of Merger Partner required to be included in or filed as
an exhibit or attached to the Registration Statement or the
Proxy Statement/Prospectus or (iii) the audited financial
statements referred to in clause (ii) above reflect any
material adverse change with respect to the assets, liabilities,
capitalization, financial condition or results of operations of
Merger Partner and its Subsidiaries, taken as a whole, as
compared to the Merger Partner Financial Statements provided by
Merger Partner to Public Company prior to the date of this
Agreement.
8.2 Effect of
Termination. In the event of termination of this
Agreement as provided in Section 8.1, this Agreement shall
immediately become void and there shall be no liability or
obligation on the part of Public Company, Merger Partner, the
Transitory Subsidiary or their respective officers, directors,
stockholders or Affiliates; provided that (a) any
such termination shall not relieve any party from liability for
any willful breach of this Agreement (which includes without
limitation the making of any representation or warranty by a
party in this Agreement that the party knew was not true and
accurate when made) and (b) the provisions of
Section 5.3 (Confidentiality), Section 8.2 (Effect of
Termination), Section 8.3 (Fees and Expenses) and
Article IX (Miscellaneous) of this Agreement and the
Confidentiality Agreement shall remain in full force and effect
and survive any termination of this Agreement.
A-63
8.3 Fees and Expenses.
(a) Except as set forth in this
Section 8.3, all fees and expenses incurred in connection
with this Agreement and the transactions contemplated hereby
shall be paid by the party incurring such expenses, whether or
not the Merger is consummated.
(b) Merger Partner and Operating Company
hereby agree, jointly and severally, to pay Public Company up to
$100,000 as reimbursement for expenses of Public Company
actually incurred relating to the transactions contemplated by
this Agreement prior to termination (including, but not limited
to, fees and expenses of Public Companys counsel,
accountants and financial advisors, but excluding any
discretionary fees paid to such financial advisors), upon the
termination of this Agreement (i) by Public Company or
Merger Partner pursuant to Section 8.1(b) if the failure to
satisfy the conditions set forth in the first sentence of
Section 7.1(a) or Section 7.2(a), (b), (g) or
(h) by the Outside Date shall have resulted in the Closing
not occurring; or (ii) by Public Company pursuant to
Section 8.1(e), (g), (i) or (j).
(c) Merger Partner and Operating Company
hereby agree, jointly and severally, to pay Public Company a
termination fee of $1,000,000 in the event of the termination of
this Agreement:
(i) by Public Company pursuant to
Section 8.1(b) (if the failure to satisfy the conditions
set forth in the first sentence of Section 7.1(a) or in
Section 7.2(b), (g) or (h) by the Outside Date
shall have resulted in the Closing not occurring); or
(ii) by Public Company pursuant to
Section 8.1(e), Section 8.1(g) (as a result of Merger
Partners failure to perform any covenant or agreement
described therein), Section 8.1(i) (provided that Public
Company shall not have provided its notice of termination under
such Section on or before the second business day immediately
following the date of this Agreement) or Section 8.1(j)(ii)
or (j)(iii).
(d) Public Company hereby agrees to pay
Merger Partner up to $150,000 as reimbursement for expenses of
Public Company actually incurred relating to the transactions
contemplated by this Agreement prior to termination (including,
but not limited to, fees and expenses of Merger Partners
counsel, accountants and financial advisors, but excluding any
discretionary fees paid to such financial advisors), upon the
termination of this Agreement by (i) Merger Partner or
Public Company pursuant to Section 8.1(b) if the failure to
satisfy the conditions set forth in the second sentence of
Section 7.1(a) or Section 7.3(a), (b), or (f) by
the Outside Date shall have resulted in the Closing not
occurring; (ii) by Merger Partner or Public Company
pursuant to Section 8.1(d), or (iii) by Merger Partner
pursuant to Section 8.1(f) or (h).
(e) Public Company hereby agrees to pay
Merger Partner a termination fee of $1,000,000 in the event of
the termination of this Agreement:
(i) by Merger Partner pursuant to
Section 8.1(b) (if the failure to satisfy the conditions
set forth in the second sentence of Section 7.1(a) or in
Section 7.3(b) or (f) by the Outside Date shall have
resulted in the Closing not occurring);
(ii) by Merger Partner or Public Company
pursuant to Section 8.1(d) as a result of the failure to
receive the requisite vote for approval of the Public Company
Voting Proposals by the stockholders of Public Company at the
Public Company Meeting if, at or prior to the time of such
failure, there shall have been announced an Acquisition Proposal
relating to Public Company that shall not have been absolutely
and unconditionally withdrawn and abandoned; or
(iii) by Merger Partner pursuant to
Section 8.1(f) or Section 8.1(h) (as a result of
Public Companys failure to perform any covenant or
agreement described therein).
(f) The expenses and fees, if applicable,
payable pursuant to Section 8.3(b), 8.3(c), 8.3(d) and
8.3(e) shall be paid by wire transfer of
same-day
funds within one business day after demand therefor following
the first to occur of the events giving rise to the payment
obligation described in Section 8.3(b), 8.3(c), 8.3(d) or
8.3(e); provided that in no event shall Public Company or
Merger Partner and Operating Company, as the case may be, be
required to pay the expenses and fees, if applicable, to the
other, if, immediately prior to the termination of this
Agreement, the party to receive the expenses and fees, if
applicable, was in material breach of its obligations under this
Agreement. If one party fails to promptly pay to the other any
expense reimbursement or fee due hereunder, the defaulting party
shall pay the costs and
A-64
expenses (including legal fees and expenses) in connection with
any action, including the filing of any lawsuit or other legal
action, taken to collect payment, together with interest on the
amount of any unpaid fee at the publicly announced prime rate of
Bank of America, N.A. plus five percent per annum, compounded
quarterly, from the date such expense reimbursement or fee was
required to be paid.
(g) Payment of any termination fee
described in this Section 8.3 shall not be in lieu of
damages incurred in the event of a breach of this Agreement
described in clause (a) of Section 8.2.
8.4 Amendment. This
Agreement may be amended by the parties hereto, by action taken
or authorized by their respective Boards of Directors, at any
time before or after approval of the matters presented in
connection with the Merger by the stockholders of any of the
parties, but, after any such approval, no amendment shall be
made which by law requires further approval by such stockholders
without such further approval. This Agreement may not be amended
except by an instrument in writing signed on behalf of each of
the parties hereto.
8.5 Extension;
Waiver. At any time prior to the Effective Time,
the parties hereto, by action taken or authorized by their
respective Boards of Directors, may, to the extent legally
allowed, (a) extend the time for the performance of any of
the obligations or other acts of the other parties hereto,
(b) waive any inaccuracies in the representations and
warranties contained herein or in any document delivered
pursuant hereto and (c) waive compliance with any of the
agreements or conditions contained herein. Any agreement on the
part of a party hereto to any such extension or waiver shall be
valid only if set forth in a written instrument signed on behalf
of such party. Such extension or waiver shall not be deemed to
apply to any time for performance, inaccuracy in any
representation or warranty, or noncompliance with any agreement
or condition, as the case may be, other than that which is
specified in the extension or waiver. The failure of any party
to this Agreement to assert any of its rights under this
Agreement or otherwise shall not constitute a waiver of such
rights.
ARTICLE IX
MISCELLANEOUS
9.1 Nonsurvival of Representations,
Warranties and Agreements. The respective
representations and warranties of Merger Partner, Public Company
and the Transitory Subsidiary contained in this Agreement or in
any instrument delivered pursuant to this Agreement shall expire
with, and be terminated and extinguished upon, the Effective
Time. This Section 9.1 shall have no effect upon any other
obligations of the parties hereto, whether to be performed
before or after the consummation of the Merger.
9.2 Notices. All
notices and other communications hereunder shall be in writing
and shall be deemed duly delivered (i) four business days
after being sent by registered or certified mail, return receipt
requested, postage prepaid, or (ii) one business day after
being sent for next business day delivery, fees prepaid, via a
reputable nationwide overnight courier service, in each case to
the intended recipient as set forth below:
(a) if to Public Company or the
Transitory Subsidiary, to:
Critical Therapeutics, Inc.
60 Westview Street
Lexington, MA 02421
Attn: President and Chief Executive Officer
Telecopy:
(781) 862-5691
with copies (which shall not constitute notice) to:
Wilmer Cutler Pickering Hale and Dorr LLP
399 Park Avenue
New York, NY 10022
Attn: Steven D. Singer
Telecopy:
(212) 230-8888
A-65
and
Critical Therapeutics, Inc.
60 Westview Street
Lexington, MA 02421
Attn: General Counsel
Telecopy:
(781) 862-5691
(b) if to Merger Partner, to:
Cornerstone BioPharma Holdings, Inc.
2000 Regency Parkway, Suite 255
Cary, North Carolina 27511
Attn: President and Chief Executive Officer
Telecopy:
(919) 678-6599
with a copy (which shall not constitute notice) to:
Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan,
L.L.P.
2500 Wachovia Capitol Center
Post Office Box 2611
Raleigh, NC
27602-2611
Attn: Merrill M. Mason
Telecopy:
(919) 821-6800
Any party to this Agreement may give any notice or other
communication hereunder using any other means (including
personal delivery, messenger service, telecopy, ordinary mail or
electronic mail), but no such notice or other communication
shall be deemed to have been duly given unless and until it
actually is received by the party for whom it is intended. Any
party to this Agreement may change the address to which notices
and other communications hereunder are to be delivered by giving
the other parties to this Agreement notice in the manner herein
set forth.
9.3 Entire
Agreement. This Agreement (including the
Schedules and Exhibits hereto and the documents and instruments
referred to herein that are to be delivered at the Closing)
constitutes the entire agreement among the parties to this
Agreement and supersedes any prior understandings, agreements or
representations by or among the parties hereto, or any of them,
written or oral, with respect to the subject matter hereof;
provided that the Confidentiality Agreement shall remain
in effect in accordance with its terms.
9.4 No Third Party
Beneficiaries. Except as provided in
Section 6.9, and subject to Section 9.5, this
Agreement is not intended, and shall not be deemed, to confer
any rights or remedies upon any person other than the parties
hereto and their respective successors and permitted assigns, to
create any agreement of employment with any person or to
otherwise create any third-party beneficiary hereto.
9.5 Assignment. No
party may assign any of its rights or delegate any of its
performance obligations under this Agreement, in whole or in
part, by operation of law or otherwise without the prior written
consent of the other parties. Subject to the preceding sentence,
this Agreement shall be binding upon, inure to the benefit of,
and be enforceable by, the parties hereto and their respective
successors and permitted assigns. Any purported assignment of
rights or delegation of performance obligations in violation of
this Section 9.5 shall be null and void.
9.6 Severability. Any
term or provision of this Agreement that is invalid or
unenforceable in any situation in any jurisdiction shall not
affect the validity or enforceability of the remaining terms and
provisions hereof or the validity or enforceability of the
offending term or provision in any other situation or in any
other jurisdiction. If the final judgment of a court of
competent jurisdiction declares that any term or provision
hereof is invalid or unenforceable, the parties hereto agree
that the court making such determination shall have the power to
limit the term or provision, to delete specific words or
phrases, or to replace any invalid or unenforceable term or
provision with a term or provision that is valid and enforceable
and that comes closest to expressing the intention of the
invalid or unenforceable term or provision, and this Agreement
shall be enforceable as so modified. In the event such court
does not exercise the power granted to it in the prior
A-66
sentence, the parties hereto agree to replace such invalid or
unenforceable term or provision with a valid and enforceable
term or provision that will achieve, to the extent possible, the
economic, business and other purposes of such invalid or
unenforceable term.
9.7 Counterparts and
Signature. This Agreement may be executed in two
or more counterparts, each of which shall be deemed an original
but all of which together shall be considered one and the same
agreement and shall become effective when counterparts have been
signed by each of the parties hereto and delivered to the other
parties, it being understood that all parties need not sign the
same counterpart. The exchange of copies of this Agreement or
amendments thereto and of signature pages by facsimile
transmission or by email transmission in portable document
format, or similar format, shall constitute effective execution
and delivery of such instrument(s) as to the parties and may be
used in lieu of the original Agreement or amendment for all
purposes. Signatures of the parties transmitted by facsimile or
by email transmission in portable document format, or similar
format, shall be deemed to be their original signatures for all
purposes.
9.8 Interpretation. When
reference is made in this Agreement to an Article or a Section,
such reference shall be to an Article or Section of this
Agreement, unless otherwise indicated. The table of contents,
table of defined terms and headings contained in this Agreement
are for convenience of reference only and shall not affect in
any way the meaning or interpretation of this Agreement. The
language used in this Agreement shall be deemed to be the
language chosen by the parties hereto to express their mutual
intent, and no rule of strict construction shall be applied
against any party. Whenever the context may require, any
pronouns used in this Agreement shall include the corresponding
masculine, feminine or neuter forms, and the singular form of
nouns and pronouns shall include the plural, and vice versa. Any
reference to any federal, state, local or foreign statute or law
shall be deemed also to refer to all rules and regulations
promulgated thereunder, unless the context requires otherwise.
Whenever the words include, includes or
including are used in this Agreement, they shall be
deemed to be followed by the words without
limitation. No summary of this Agreement prepared by any
party shall affect the meaning or interpretation of this
Agreement.
9.9 Governing Law. All
matters arising out of or relating to this Agreement and the
transactions contemplated hereby (including without limitation
its interpretation, construction, performance and enforcement)
shall be governed by and construed in accordance with the
internal laws of the State of Delaware without giving effect to
any choice or conflict of law provision or rule (whether of the
State of Delaware or any other jurisdiction) that would cause
the application of laws of any jurisdictions other than those of
the State of Delaware.
9.10 Remedies. Except
as otherwise provided herein, any and all remedies herein
expressly conferred upon a party will be deemed cumulative with
and not exclusive of any other remedy conferred hereby, or by
law or equity upon such party, and the exercise by a party of
any one remedy will not preclude the exercise of any other
remedy. The parties hereto agree that irreparable damage would
occur in the event that any of the provisions of this Agreement
were not performed in accordance with their specific terms or
were otherwise breached and that monetary damages would not be a
sufficient remedy for a breach of this Agreement. It is
accordingly agreed that the parties shall be entitled to an
injunction or injunctions to prevent breaches of this Agreement
and to enforce specifically the terms and provisions of this
Agreement, this being in addition to any other remedy to which
they are entitled at law or in equity.
9.11 Submission to
Jurisdiction. Each of the parties to this
Agreement (a) consents to submit itself to the exclusive
personal jurisdiction of the Court of Chancery of the State of
Delaware in any action or proceeding arising out of or relating
to this Agreement or any of the transactions contemplated by
this Agreement, (b) agrees that all claims in respect of
such action or proceeding may be heard and determined in such
court, (c) agrees that it shall not attempt to deny or
defeat such personal jurisdiction by motion or other request for
leave from any court and (d) agrees not to bring any action
or proceeding arising out of or relating to this Agreement or
any of the transaction contemplated by this Agreement in any
other court. Each of the parties hereto waives any defense of
inconvenient forum to the maintenance of any action or
proceeding so brought and waives any bond, surety or other
security that might be required of any other party with respect
thereto. Any party may make service on another party by sending
or delivering a copy of the process to the party to be served at
the address and in the manner provided for the giving of notices
in Section 9.2. Nothing in this Section 9.11, however,
shall affect the right of any party to serve legal process in
any other manner permitted by law.
A-67
9.12 WAIVER OF JURY
TRIAL. EACH OF PUBLIC COMPANY, THE TRANSITORY
SUBSIDIARY AND MERGER PARTNER HEREBY IRREVOCABLY WAIVES ALL
RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM
(WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR
RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED
HEREBY OR THE ACTIONS OF PUBLIC COMPANY, THE TRANSITORY
SUBSIDIARY OR MERGER PARTNER IN THE NEGOTIATION, ADMINISTRATION,
PERFORMANCE AND ENFORCEMENT OF THIS AGREEMENT.
9.13 Operating Company
Guarantee. Operating Company unconditionally
guarantees to Public Company the full and complete performance
by Merger Partner or the Surviving Corporation, as applicable,
of its respective obligations under this Agreement and shall be
liable for any breach of any representation, warranty, covenant
or obligation of Merger Partner or the Surviving Corporation, as
applicable, under this Agreement. This is a guarantee of payment
and performance and not collectibility. Operating Company hereby
waives diligence, presentment, demand of performance, filing of
any claim, any right to require any proceeding first against
Merger Partner or the Surviving Corporation, as applicable,
protest, notice and all demands whatsoever in connection with
the performance of its obligations set forth in this
Section 9.13. Prior to the Effective Time, Operating
Company shall not have any right of subrogation, reimbursement
or indemnity whatsoever, nor any right of recourse to security
for any of the agreements, covenants and obligations of Merger
Partner or the Surviving Corporation under this Agreement.
[Remainder
of Page Intentionally Left Blank]
A-68
IN WITNESS WHEREOF, Public Company, the Transitory Subsidiary
and Merger Partner have caused this Agreement to be signed by
their respective officers thereunto duly authorized as of the
date first written above.
CRITICAL THERAPEUTICS, INC.
Name: Trevor Phillips
Title: President and Chief Executive Officer
NEPTUNE ACQUISITION CORP.
Name: Trevor Phillips
Title: President
CORNERSTONE BIOPHARMA HOLDINGS, INC.
Name: Craig A. Collard
Operating Company has caused this Agreement to be signed by its
duly authorized officer for purposes of agreeing to be bound by
the provisions of Sections 8.3 and 9.13 hereof.
CORNERSTONE BIOPHARMA, INC.
Name: Craig A. Collard
Title: CEO
[Signature
Page to Agreement and Plan of Merger]
A-69
Schedule A-1
Merger
Partner Key Stockholders
Cornerstone Biopharma Holdings, Ltd.
Craig Collard Irrevocable Trust
James V. Baker
Chenyqua Baldwin
Lutz Family Limited Partnership
Craig A. Collard
Alastair McEwan
George Esgro
Brian Dickson
Steven Lutz
A-70
Schedule A-2
Public
Company Key Stockholders
Funds managed by Healthcare Ventures:
|
|
|
|
|
HealthCare Ventures VI, L.P.
|
|
|
|
HealthCare Ventures VII, L.P.
|
Funds managed by Advanced Technology Ventures:
|
|
|
|
|
Advanced Technology Ventures VII, L.P.
|
|
|
|
Advanced Technology Ventures VII (B), L.P.
|
|
|
|
Advanced Technology Ventures VII (C), L.P.
|
|
|
|
ATV Entrepreneurs VII, L.P.
|
|
|
|
ATV Alliance 2003, L.P.
|
|
|
|
Advanced Technology Ventures VI, L.P.
|
|
|
|
ATV Entrepreneurs VI, L.P.
|
A-71
Schedule 6.13
Officer
Appointments
|
|
|
Name
|
|
Title
|
|
Craig A. Collard
|
|
President and Chief Executive Officer
|
George Esgro
|
|
Vice President, Sales and Marketing
|
Brian Dickson
|
|
Chief Medical Officer
|
Steven Lutz
|
|
Executive Vice President, Manufacturing and Trade
|
A-72
Schedule 6.14(a)
Director
Appointments
Craig A. Collard
Alastair McEwan
A-73
Schedule 6.14(b)
Director
Resignations
Jean George
Christopher Mirabelli, Ph.D.
Trevor Phillips, Ph.D.
Richard W. Dugan (unless Merger Partner determines in its
discretion that he should continue, and he is willing to
continue, as a director of Public Company after the Effective
Time)
A-74
EXHIBIT A-1
MERGER
PARTNER
STOCKHOLDER
AGREEMENT
THIS STOCKHOLDER AGREEMENT (this Agreement),
dated as of May , 2008, is by and among
Critical Therapeutics, Inc., a Delaware corporation
(Public Company), Cornerstone BioPharma
Holdings, Inc., a Delaware corporation (Merger
Partner) (only with respect to Section 2(b)
hereof), and the undersigned stockholder
(Stockholder) of Merger Partner.
WHEREAS, concurrently with the execution and delivery of this
Agreement, Public Company, Neptune Acquisition Corp., a Delaware
corporation and a wholly owned subsidiary of Public Company (the
Transitory Subsidiary), and Merger Partner
have entered into an Agreement and Plan of Merger, dated as of
the date hereof (as it may be amended or supplemented from time
to time pursuant to the terms thereof, the Merger
Agreement), which provides for the merger (the
Merger) of the Transitory Subsidiary into
Merger Partner in accordance with the terms of the Merger
Agreement;
WHEREAS, Stockholder is the beneficial owner (as defined in
Rule 13d-3
under the Exchange Act) of such number of shares of each class
of capital stock of Merger Partner as is indicated on the
signature page of this Agreement; and
WHEREAS, in consideration of the execution and delivery of the
Merger Agreement by Public Company and the Transitory
Subsidiary, Stockholder desires to agree to vote the Shares (as
defined herein) over which Stockholder has voting power so as to
facilitate the consummation of the Merger;
NOW, THEREFORE, in consideration of the foregoing, intending to
be legally bound, the parties hereto hereby agree as follows:
1. Certain Definitions.
(a) Capitalized terms used but not
otherwise defined herein shall have the meanings ascribed
thereto in the Merger Agreement. For purposes of this Agreement,
the following terms shall have the following meanings:
Constructive Sale means with respect to any
security, a short sale with respect to such security, entering
into or acquiring an offsetting derivative contract with respect
to such security, entering into or acquiring a futures or
forward contract to deliver such security or entering into any
other hedging or other derivative transaction that has the
effect of either directly or indirectly materially changing the
economic benefits or risks of ownership.
Shares means (i) all shares of capital
stock of Merger Partner owned, beneficially or of record, by
Stockholder as of the date hereof, and (ii) all additional
shares of capital stock of Merger Partner acquired by
Stockholder, beneficially or of record, during the period
commencing with the execution and delivery of this Agreement and
expiring on the Expiration Date (as such term is defined in
Section 11 below).
Transfer means, with respect to any security,
the direct or indirect assignment, sale, transfer, tender,
exchange, pledge, hypothecation, or the grant, creation or
suffrage of a lien, security interest or encumbrance in or upon,
or the gift, placement in trust, or the Constructive Sale or
other disposition of such security (including transfers by
testamentary or intestate succession or otherwise by operation
of law) or any right, title or interest therein (including, but
not limited to, any right or power to vote to which the holder
thereof may be entitled, whether such right or power is granted
by proxy or otherwise), or the record or beneficial ownership
thereof, the offer to make such a sale, transfer, Constructive
Sale or other disposition, and each agreement, arrangement or
understanding, whether or not in writing, to effect any of the
foregoing.
A-75
2. Transfer and Voting
Restrictions With Respect to the Shares.
(a) At all times during the period
commencing with the execution and delivery of this Agreement and
expiring on the Expiration Date, Stockholder shall not, except
in connection with the Merger or as the result of the death of
Stockholder, Transfer any of the Shares, or discuss, negotiate,
make an offer or enter into an agreement, commitment or other
arrangement with respect thereto, unless the person to which
such Shares are being Transferred shall have executed and
delivered a counterpart of this Agreement and agreed pursuant
thereto, for the benefit of Public Company and Transitory
Subsidiary, to hold such Shares subject to all terms and
conditions of this Agreement.
(b) Stockholder understands and agrees
that if Stockholder attempts to Transfer, vote or provide any
other person with the authority to vote any of the Shares other
than in compliance with this Agreement, Merger Partner shall
not, and Stockholder hereby unconditionally and irrevocably
instructs Merger Partner to not, (i) permit any such
Transfer on its books and records, (ii) issue a new
certificate representing any of the Shares or (iii) record
such vote, in each case, unless and until Stockholder shall have
complied with the terms of this Agreement.
(c) Except as otherwise permitted by this
Agreement or by order of a court of competent jurisdiction,
Stockholder will not commit any act that could restrict or
affect Stockholders legal power, authority and right to
vote all of the Shares then owned of record or beneficially by
Stockholder or otherwise prevent or disable Stockholder from
performing any of his, her or its obligations under this
Agreement. Without limiting the generality of the foregoing,
except for this Agreement and as otherwise permitted by this
Agreement, Stockholder will not enter into any voting agreement
with any person or entity with respect to any of the Shares,
grant any person or entity any proxy (revocable or irrevocable)
or power of attorney with respect to any of the Shares, deposit
any of the Shares in a voting trust or otherwise enter into any
agreement or arrangement with any person or entity limiting or
affecting Stockholders legal power, authority or right to
vote the Shares in favor of the approval of the Proposed
Transaction.
3. Agreement to Vote Shares.
(a) Prior to the Expiration Date, at
every meeting of the stockholders of Merger Partner called, and
at every adjournment or postponement thereof, and on every
action or approval by written consent of the stockholders of
Merger Partner, Stockholder (in Stockholders capacity as
such) shall appear at the meeting or otherwise cause the Shares
to be present thereat for purposes of establishing a quorum and,
to the extent not voted by the persons appointed as proxies
pursuant to this Agreement, vote (i) in favor of adoption
of the Merger Agreement and approval of the transactions
contemplated thereby (collectively, the Proposed
Transaction), (ii) against the approval or
adoption of any proposal made in opposition to, or in
competition with, the Proposed Transaction, and
(iii) against any of the following (to the extent unrelated
to the Proposed Transaction): (A) any merger, consolidation
or business combination involving Merger Partner or any of its
subsidiaries other than the Proposed Transaction; (B) any
sale, lease or transfer of all or substantially all of the
assets of Merger Partner or any of its subsidiaries;
(C) any reorganization, recapitalization, dissolution,
liquidation or winding up of Merger Partner or any of its
subsidiaries; or (D) any other action that is intended, or
could reasonably be expected, to result in a breach of any
covenant, representation or warranty or any other obligation or
agreement of Merger Partner under the Merger Agreement or of
Stockholder under this Agreement or otherwise impede, interfere
with, delay, postpone, discourage or adversely affect the
consummation of the Proposed Transaction (each of (ii) and
(iii), a Competing Transaction).
(b) If Stockholder is the beneficial
owner, but not the record holder, of the Shares, Stockholder
agrees to take all actions necessary to cause the record holder
and any nominees to vote all of the Shares in accordance with
Section 3(a).
4. Grant of Irrevocable
Proxy.
(a) Stockholder hereby irrevocably (to
the fullest extent permitted by law) grants to, and appoints,
Public Company and each of its executive officers and any of
them, in their capacities as officers of Public Company (the
Grantees), as Stockholders proxy and
attorney-in-fact (with full power of substitution and
re-substitution), for and in the name, place and stead of
Stockholder, to vote the Shares, to instruct
A-76
nominees or record holders to vote the Shares, or grant a
consent or approval in respect of such Shares in accordance with
Section 3 hereof and, in the discretion of the Grantees
with respect to any proposed adjournments or postponements of
any meeting of stockholders at which any of the matters
described in Section 3 hereof is to be considered.
(b) Stockholder represents that any
proxies heretofore given in respect of the Shares that may still
be in effect are not irrevocable, and such proxies are hereby
revoked.
(c) Stockholder hereby affirms that the
irrevocable proxy set forth in this Section 4 is given in
connection with the execution of the Merger Agreement, and that
such irrevocable proxy is given to secure the performance of the
duties of Stockholder under this Agreement. Stockholder hereby
further affirms that the irrevocable proxy is coupled with an
interest and may under no circumstances be revoked. Stockholder
hereby ratifies and confirms all that such irrevocable proxy may
lawfully do or cause to be done by virtue hereof. Such
irrevocable proxy is executed and intended to be irrevocable in
accordance with the provisions of Section 212 of the
Delaware General Corporation Law.
(d) The Grantees may not exercise this
irrevocable proxy on any other matter except as provided above.
Stockholder may vote the Shares on all other matters.
(e) Public Company may terminate this
proxy with respect to Stockholder at any time at its sole
election by written notice provided to Stockholder.
5. No
Solicitation. Stockholder, in his, her or its
capacity as a Stockholder, shall not directly or indirectly,
(a) solicit, initiate, encourage, induce or facilitate the
making, submission or announcement of any Acquisition Proposal
or take any action that could reasonably be expected to lead to
an Acquisition Proposal, (b) furnish any information with
respect to or in connection with or in response to an
Acquisition Proposal or an inquiry or indication of interest
that could reasonably be expected to lead to an Acquisition
Proposal, (c) engage in discussions or negotiations with
any person with respect to any Acquisition Proposal,
(d) approve, endorse or recommend any Acquisition Proposal
or (e) enter into any letter of intent or similar document
or any contract contemplating or otherwise relating to any
Acquisition Proposal.
6. Lock-Up
With Respect to Public Company Common
Stock. Stockholder shall not during the period
commencing upon the Effective Time and ending 180 days
after the date on which the Effective Time occurs, Transfer any
shares of Public Company Common Stock or any securities
convertible into or exercisable or exchangeable for Public
Company Common Stock. The foregoing sentence shall not apply to
(a) transactions relating to shares of Public Company
Common Stock or other securities acquired in open market
transactions after the Effective Time; provided that no
filing under Section 16(a) of the Exchange Act shall be
required or shall be voluntarily made in connection with
subsequent sales of shares of Public Company Common Stock
acquired in such open market transactions; (b) transfers of
shares of Public Company Common Stock as a bona fide gift;
(c) distributions of shares of Public Company Common Stock
to limited partners, members or shareholders of the Stockholder;
(d) transfers to any family limited partnership or family
limited liability company whose partnership or equity interests
are owned by, or a trust for the direct or indirect benefit of,
or controlled by, the Stockholder or the immediate family of the
Stockholder; (e) transfers to the Stockholders
Affiliates or to any investment fund or other entity controlled
or managed by the Stockholder; provided that in the case
of any transfer or distribution pursuant to clause (b), (c),
(d) or (e), (i) each donee, distributee or transferee
shall sign and deliver a
lock-up
letter containing substantially similar provisions as are set
forth in this Section 6 and (ii) no filing under
Section 16(a) of the Exchange Act, reporting a reduction in
beneficial ownership of shares of Public Company Common Stock,
shall be required or shall be voluntarily made during the
restricted period referred to in the foregoing sentence; or
(f) transfers to any beneficiary of the Stockholder
pursuant to will, intestacy or other testamentary document or
applicable laws of descent. In addition, the Stockholder agrees
that, without the prior written consent of Public Company, it
will not, during the period commencing on the Effective Time and
ending 180 days after the date on which the Effective Time
occurs, make any demand for or exercise any right with respect
to, the registration of any shares of Public Company Common
Stock or any securities convertible into or exercisable or
exchangeable for Public Company Common Stock. The Stockholder
also agrees and consents to the entry of stop transfer
instructions with Public Companys transfer agent and
registrar against the transfer of the undersigneds shares
A-77
of Public Company Common Stock or any securities convertible
into or exercisable or exchangeable for Public Company Common
Stock except in compliance with the foregoing restrictions.
7. Action in Stockholder
Capacity Only. Stockholder makes no agreement or
understanding herein as a director or officer of Merger Partner.
Stockholder signs solely in Stockholders capacity as a
record holder and beneficial owner, as applicable, of Shares,
and nothing herein shall limit or affect any actions taken in
Stockholders capacity as an officer or director of Merger
Partner.
8. Representations and
Warranties of Stockholder.
(a) Stockholder hereby represents and
warrants to Public Company as follows: (i) Stockholder is
the beneficial or record owner of the shares of capital stock of
Merger Partner indicated on the signature page of this Agreement
free and clear of any and all pledges, liens, security
interests, mortgage, claims, charges, restrictions, options,
title defects or encumbrances; (ii) Stockholder does not
beneficially own any securities of Merger Partner other than the
shares of capital stock and rights to purchase shares of capital
stock of Merger Partner set forth on the signature page of this
Agreement; (iii) Stockholder has full power and authority
to make, enter into and carry out the terms of this Agreement
and to grant the irrevocable proxy as set forth in
Section 4; and (iv) this Agreement has been duly and
validly executed and delivered by Stockholder and constitutes a
valid and binding agreement of Stockholder enforceable against
Stockholder in accordance with its terms. Stockholder agrees to
notify Public Company promptly of any additional shares of
capital stock of Merger Partner of which Stockholder becomes the
beneficial owner after the date of this Agreement.
(b) As of the date hereof and for so long
as this Agreement remains in effect, except for this Agreement
or as otherwise permitted by this Agreement, Stockholder has
full legal power, authority and right to vote all of the Shares
then owned of record or beneficially by Stockholder, in favor of
the approval and authorization of the Proposed Transaction
without the consent or approval of, or any other action on the
part of, any other person or entity (including, without
limitation, any governmental entity). Without limiting the
generality of the foregoing, Stockholder has not entered into
any voting agreement (other than this Agreement) with any person
with respect to any of the Shares, granted any person any proxy
(revocable or irrevocable) or power of attorney with respect to
any of the Shares, deposited any of the Shares in a voting trust
or entered into any arrangement or agreement with any person
limiting or affecting Stockholders legal power, authority
or right to vote the Shares on any matter.
(c) The execution and delivery of this
Agreement and the performance by Stockholder of his, her or its
agreements and obligations hereunder will not result in any
breach or violation of or be in conflict with or constitute a
default under any term of any agreement, judgment, injunction,
order, decree, law, regulation or arrangement to which
Stockholder is a party or by which Stockholder (or any of his,
her or its assets) is bound, except for any such breach,
violation, conflict or default which, individually or in the
aggregate, would not impair or adversely affect
Stockholders ability to perform his, her or its
obligations under this Agreement or render inaccurate any of the
representations made by Stockholder herein.
(d) Except as disclosed pursuant to the
Merger Agreement, no investment banker, broker, finder or other
intermediary is entitled to a fee or commission from Public
Company, the Transitory Subsidiary or Merger Partner in respect
of this Agreement based upon any arrangement or agreement made
by or on behalf of Stockholder.
(e) Stockholder understands and
acknowledges that Public Company, the Transitory Subsidiary and
Merger Partner are entering into the Merger Agreement in
reliance upon Stockholders execution and delivery of this
Agreement and the representations and warranties of Stockholder
contained herein.
9. Exchange of Shares; Waiver of
Rights of Appraisal. If the Merger is
consummated, the Shares shall, pursuant to the terms of the
Merger Agreement, be exchanged for the consideration provided in
the Merger Agreement. Stockholder hereby waives, and agrees to
prevent the exercise of, any rights of appraisal with respect to
the Merger, or rights to dissent from the Merger, that such
Stockholder may have by virtue of his, her or its beneficial
ownership of the Shares.
A-78
10. Confidentiality. Stockholder
recognizes that successful consummation of the Proposed
Transaction may be dependent upon confidentiality with respect
to the matters referred to herein. In this connection, pending
public disclosure thereof, and so that Public Company may rely
on the safe harbor provisions of Rule 100(b)(2)(ii) of
Regulation FD promulgated under the Exchange Act,
Stockholder hereby agrees not to disclose or discuss such
matters with anyone not a party to this Agreement (other than
its counsel and advisors, if any) without the prior written
consent of Public Company and Merger Partner, except for
disclosures Stockholders counsel advises are required by
applicable law, in which case Stockholder shall give notice of
such disclosure to Public Company and Merger Partner as promptly
as practicable so as to enable Public Company and Merger Partner
to seek a protective order from a court of competent
jurisdiction with respect thereto.
11. Termination. This
Agreement, other than Sections 6 and 12 hereof, shall
terminate and be of no further force or effect whatsoever as of
the earlier of (a) such date and time as the Merger
Agreement shall have been validly terminated pursuant to the
terms of Article 8 thereof or (b) the Effective Time
(the Expiration Date). Notwithstanding
anything in this Agreement to the contrary, Sections 6 and
12 hereof shall remain in full force and effect following the
Effective Time for the time period provided in Section 6.
12. Miscellaneous Provisions.
(a) Amendments, Modifications and
Waivers. This Agreement may not be amended or
modified except by an instrument in writing signed on behalf of
each of the parties hereto. Any agreement on the part of a party
hereto to any waiver of any term or condition hereof shall be
valid only if set forth in a written instrument signed on behalf
of such party. Such waiver shall not be deemed to apply to any
term or condition other than that which is specified in such
waiver. The failure of any party to this Agreement to assert any
of its rights under this Agreement or otherwise shall not
constitute a waiver of such rights.
(b) Entire
Agreement. This Agreement constitutes the entire
agreement among the parties to this Agreement and supersedes any
prior understandings, agreements or representations by or among
the parties hereto, or any of them, written or oral, with
respect to the subject matter hereof.
(c) Governing Law. All
matters arising out of or relating to this Agreement and the
transactions contemplated hereby (including without limitation
its interpretation, construction, performance and enforcement)
shall be governed by and construed in accordance with the
internal laws of the State of Delaware without giving effect to
any choice or conflict of law provision or rule (whether of the
State of Delaware or any other jurisdiction) that would cause
the application of laws of any jurisdictions other than those of
the State of Delaware.
(d) Submission to
Jurisdiction. Each of the parties to this
Agreement (i) consents to submit itself to the exclusive
personal jurisdiction of the Court of Chancery of the State of
Delaware in any action or proceeding arising out of or relating
to this Agreement or any of the transactions contemplated by
this Agreement, (ii) agrees that all claims in respect of
such action or proceeding may be heard and determined in such
court, (iii) agrees that it shall not attempt to deny or
defeat such personal jurisdiction by motion or other request for
leave from such court and (d) agrees not to bring any
action or proceeding arising out of or relating to this
Agreement or any of the transaction contemplated by this
Agreement in any other court. Each of the parties hereto waives
any defense of inconvenient forum to the maintenance of any
action or proceeding so brought and waives any bond, surety or
other security that might be required of any other party with
respect thereto. Any party may make service on another party by
sending or delivering a copy of the process to the party to be
served at the address and in the manner provided for the giving
of notices in Section 12(m) hereof. Nothing in this
Section 12(d), however, shall affect the right of any party
to serve legal process in any other manner permitted by law.
(e) WAIVER OF JURY
TRIAL. EACH OF THE PARTIES HERETO HEREBY
IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION,
PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR
OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE
TRANSACTIONS CONTEMPLATED HEREBY OR THE
A-79
ACTIONS OF ANY PARTY IN THE NEGOTIATION, ADMINISTRATION,
PERFORMANCE AND ENFORCEMENT OF THIS AGREEMENT.
(f) Attorneys
Fees. In any action at law or suit in equity to
enforce this Agreement or the rights of any of the parties
hereunder, the prevailing party in such action or suit shall be
entitled to receive its reasonable attorneys fees and all
other reasonable costs and expenses incurred in such action or
suit.
(g) Assignment and
Successors. No party may assign any of its rights
or delegate any of its performance obligations under this
Agreement, in whole or in part, by operation of law or otherwise
without the prior written consent of the other parties, except
that Public Company, without obtaining the consent of any other
parties hereto, shall be entitled to assign this Agreement or
all or any of its rights or obligations hereunder to any one or
more of its Affiliates. No assignment by Public Company under
this Section 12(g) shall relieve Public Company of its
obligations under this Agreement. Subject to the foregoing, this
Agreement shall be binding upon, inure to the benefit of, and be
enforceable by, the parties hereto and their respective
successors and permitted assigns, including, without limitation,
Stockholders estate and heirs upon the death of
Stockholder. Any purported assignment of rights or delegation of
performance obligations in violation of this Section 12(g)
shall be null and void.
(h) No Third Party
Beneficiaries. This Agreement is not intended,
and shall not be deemed, to confer any rights or remedies upon
any person other than the parties hereto and their respective
successors and permitted assigns, or to otherwise create any
third-party beneficiary hereto.
(i) Cooperation. Stockholder
agrees to cooperate fully with Public Company and to execute and
deliver such further documents, certificates, agreements and
instruments and to take such other actions as may be reasonably
requested by Public Company to evidence or reflect the
transactions contemplated by this Agreement and to carry out the
intent and purpose of this Agreement. Stockholder hereby agrees
that Public Company and Merger Partner may publish and disclose
in the Registration Statement and any resale registration
statement relating thereto (including all documents and
schedules filed with the SEC) and the Proxy
Statement/Prospectus, such Stockholders identity and
ownership of Shares and the nature of such Stockholders
commitments, arrangements and understandings under this
Agreement and may further file this Agreement as an exhibit to
the Registration Statement or in any other filing made by Public
Company or Merger Partner with the SEC relating to the Proposed
Transaction.
(j) Severability. Any
term or provision of this Agreement that is invalid or
unenforceable in any situation in any jurisdiction shall not
affect the validity or enforceability of the remaining terms and
provisions hereof or the validity or enforceability of the
offending term or provision in any other situation or in any
other jurisdiction. If the final judgment of a court of
competent jurisdiction declares that any term or provision
hereof is invalid or unenforceable, the parties hereto agree
that the court making such determination shall have the power to
limit the term or provision, to delete specific words or
phrases, or to replace any invalid or unenforceable term or
provision with a term or provision that is valid and enforceable
and that comes closest to expressing the intention of the
invalid or unenforceable term or provision, and this Agreement
shall be enforceable as so modified. In the event such court
does not exercise the power granted to it in the prior sentence,
the parties hereto agree to replace such invalid or
unenforceable term or provision with a valid and enforceable
term or provision that will achieve, to the extent possible, the
economic, business and other purposes of such invalid or
unenforceable term.
(k) Time of
Essence. With regard to all dates and time
periods set forth or referred to in this Agreement, time is of
the essence.
(l) Specific Performance; Injunctive
Relief. The parties hereto acknowledge that
Public Company and Merger Partner shall be irreparably harmed
and that there shall be no adequate remedy at law for a
violation of any of the covenants or agreements of Stockholder
set forth in this Agreement. Stockholder accordingly agrees
that, in addition to any other remedies that may be available to
Public Company or Merger Partner, as applicable upon any such
violation, such party shall have the right to enforce such
covenants and agreements by specific performance, injunctive
relief or by any other means available to such party at law or
in equity without posting any bond or other undertaking.
A-80
(m) Notices. All
notices and other communications hereunder shall be in writing
and shall be deemed duly delivered (i) four business days
after being sent by registered or certified mail, return receipt
requested, postage prepaid, or (ii) one business day after
being sent for next business day delivery, fees prepaid, via a
reputable nationwide overnight courier service, in each case to
the intended recipient as follows: (A) if to Public Company
or Merger Partner, to the address provided in the Merger
Agreement, including to the persons designated therein to
receive copies, and (B) if to Stockholder, to
Stockholders address shown below Stockholders
signature on the signature page hereof.
(n) Counterparts and
Signature. This Agreement may be executed in two
or more counterparts, each of which shall be deemed an original
but all of which together shall be considered one and the same
agreement and shall become effective when counterparts have been
signed by each of the parties hereto and delivered to the other
parties, it being understood that all parties need not sign the
same counterpart. The exchange of copies of this Agreement of
amendments thereto and of signature pages by facsimile
transmission or by email transmission in portable document
format, or similar format, shall constitute effective execution
and delivery of such instrument(s) as to the parties and may be
used in lieu of the original Agreement for all purposes.
Signatures of the parties transmitted by facsimile or by email
transmission in portable document format, or similar format,
shall be deemed to be their original signatures for all purposes.
(o) Headings. The
headings contained in this Agreement are for convenience of
reference only and shall not affect in any way the meaning or
interpretation of this Agreement.
(p) Legal
Representation. This Agreement was negotiated by
the parties with the benefit of legal representation and any
rule of construction or interpretation otherwise requiring this
Agreement to be construed or interpreted against any party shall
not apply to any construction or interpretation thereof.
A-81
IN WITNESS WHEREOF, the undersigned have caused this Agreement
to be duly executed as of the date first written above.
|
|
|
CRITICAL THERAPEUTICS, INC.: |
|
STOCKHOLDER: |
|
|
|
|
|
|
|
|
|
Name:
|
|
Name:
|
Title:
|
|
[Title:]
|
|
|
|
|
|
Address:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Telephone: ( ) -
|
|
|
Facsimile: ( ) -
|
|
|
E-Mail
Address:
|
Shares Beneficially Owned by Stockholder:
shares
of Merger Partner Common Stock
Merger
Partner Stock Options
Merger
Partner Warrants
[Signature
Page to Merger Partner Stockholder Agreement]
A-82
With respect to Section 2(b) only:
CORNERSTONE BIOPHARMA
HOLDINGS, INC.:
Name:
[Signature
Page to Merger Partner Stockholder Agreement]
A-83
EXHIBIT A-2
MERGER
PARTNER
NOTEHOLDER
AGREEMENT
THIS MERGER PARTNER NOTEHOLDER AGREEMENT (this
Agreement), dated as of
May , 2008, is by and among Critical
Therapeutics, Inc., a Delaware corporation (Public
Company), Cornerstone BioPharma Holdings, Inc., a
Delaware corporation (Merger Partner),
Cornerstone BioPharma, Inc., a Nevada corporation and a wholly
owned subsidiary of Merger Partner (Operating
Company), and Carolina Pharmaceuticals Ltd., a Bermuda
Exempted Company (Noteholder).
WHEREAS, concurrently with the execution and delivery of this
Agreement, Public Company, Neptune Acquisition Corp., a Delaware
corporation and a wholly owned subsidiary of Public Company (the
Transitory Subsidiary), and Merger Partner
have entered into an Agreement and Plan of Merger, dated as of
the date hereof (as it may be amended or supplemented from time
to time pursuant to the terms thereof, the Merger
Agreement), which provides for the merger (the
Merger) of the Transitory Subsidiary into
Merger Partner in accordance with the terms of the Merger
Agreement;
WHEREAS, the Noteholder is the holder of that certain Promissory
Note, dated April 19, 2004, with Operating Company, as
amended by that certain Promissory Note Amendment and Waiver
Agreement, dated June 6, 2006 (as amended, the
Carolina Note);
WHEREAS, as a condition and inducement to Public Companys
willingness to enter into the Merger Agreement, Public Company
requires that Noteholder enter into this Agreement, (i) to
covenant that Noteholder will exchange or convert the Carolina
Note into the common stock, $0.0001 par value per share, of
Merger Partner (the Merger Partner Common
Stock) prior to the Effective Time in accordance with
the terms hereof, (ii) to give Public Company a proxy to
vote all of the shares of capital stock of Merger Partner that
Noteholder owns and (iii) not to transfer or otherwise
dispose of any shares of Merger Partner Common Stock that
Noteholder owns or, for 180 days after the Effective Time,
any Public Company Common Stock received in exchange therefor
pursuant to the Merger; and
WHEREAS, in consideration of the execution and delivery of the
Merger Agreement by Public Company and the Transitory
Subsidiary, Noteholder is willing to take such actions to
facilitate the consummation of the Merger;
NOW, THEREFORE, in consideration of the foregoing, intending to
be legally bound, the parties hereto hereby agree as follows:
1. Certain Definitions.
(a) Capitalized terms used but not
otherwise defined herein shall have the meanings ascribed
thereto in the Merger Agreement. For purposes of this Agreement,
the following terms shall have the following meanings:
Constructive Sale means with respect to any
security, a short sale with respect to such security, entering
into or acquiring an offsetting derivative contract with respect
to such security, entering into or acquiring a futures or
forward contract to deliver such security or entering into any
other hedging or other derivative transaction that has the
effect of either directly or indirectly materially changing the
economic benefits or risks of ownership.
Shares means (i) all shares of capital
stock of Merger Partner owned, beneficially or of record, by
Noteholder as of the date hereof, and (ii) all additional
shares of capital stock of Merger Partner acquired by
Noteholder, beneficially or of record, during the period
commencing with the execution and delivery of this Agreement and
expiring on the Expiration Date (as such term is defined in
Section 11 below), including shares of Merger Partner
Common Stock issued to Noteholder pursuant to Section 2
hereof.
A-84
Transfer means, with respect to any security,
the direct or indirect assignment, sale, transfer, tender,
exchange, pledge, hypothecation, or the grant, creation or
suffrage of a lien, security interest or encumbrance in or upon,
or the gift, placement in trust, or the Constructive Sale or
other disposition of such security (including transfers by
testamentary or intestate succession or otherwise by operation
of law) or any right, title or interest therein (including, but
not limited to, any right or power to vote to which the holder
thereof may be entitled, whether such right or power is granted
by proxy or otherwise), or the record or beneficial ownership
thereof, the offer to make such a sale, transfer, Constructive
Sale or other disposition, and each agreement, arrangement or
understanding, whether or not in writing, to effect any of the
foregoing.
2. Conversion or Exchange of
Carolina Note.
(a) Prior to the date Public Company
first files the Registration Statement with the SEC, Noteholder
shall surrender for cancellation the Carolina Note to Operating
Company along with written instructions to Operating Company and
Merger Partner to cancel the Carolina Note and issue shares of
Merger Partner Common Stock in exchange for, at
Noteholders option, all or a portion of the Carolina Note
(but in an amount not less than the principal amount outstanding
under the Carolina Note on the date of exchange) (such amount to
be converted or exchanged, the Purchase
Amount). Upon receipt of the surrendered Carolina Note
by Operating Company, Noteholder will be deemed to be the holder
of record of the shares of Merger Partner Common Stock issuable
with respect to the Purchase Amount (as calculated under
Section 2(b)) as of the close of business on the date the
Carolina Note is surrendered to Operating Company, and Merger
Partner will promptly execute or cause to be executed and
delivered to Noteholder a certificate or certificates
representing such number of shares. If Noteholder chooses not to
convert or exchange the entire amount of principal and accrued
interest then outstanding under the Carolina Note, Operating
Company will, concurrently with Merger Partners delivery
of said stock certificate or certificates, deliver to Noteholder
a new promissory note of like tenor evidencing the remaining
outstanding amount of the Carolina Note not so converted or
exchanged for shares of Merger Partner Common Stock. Upon
surrender of the Carolina Note to Operating Company by
Noteholder, all shares of Merger Partner Common Stock
deliverable and issued hereunder will be duly authorized, duly
and validly issued and outstanding, fully paid and
nonassessable, and free from taxes, liens or charges.
(b) Upon receipt of the written
instructions from Noteholder pursuant to Section 2(a),
Merger Partner shall issue to Noteholder in respect of the
Purchase Amount a number of shares of Merger Partner Common
Stock equal to (i) the quotient of (A) the Purchase
Amount, divided by (B) the fair market value of Merger
Partner on the conversion or exchange date as determined in good
faith by the Merger Partner Board, multiplied by (ii) the
sum of (A) the number of shares of Merger Partner Common
Stock outstanding immediately prior to the conversion or
exchange plus (B) the number of shares of Merger Partner
Common Stock issuable upon exercise of Merger Partner Stock
Options and Merger Partner Warrants outstanding immediately
prior to the conversion or exchange.
3. Transfer and Voting
Restrictions With Respect to the Shares.
(a) At all times during the period
commencing with the execution and delivery of this Agreement and
expiring on the Expiration Date, Noteholder shall not, except in
connection with the Merger or as the result of the death of
Noteholder, Transfer any of the Shares, or discuss, negotiate,
make an offer or enter into an agreement, commitment or other
arrangement with respect thereto, unless the person to which
such Shares are being Transferred shall have executed and
delivered a counterpart of this Agreement and agreed pursuant
thereto, for the benefit of Public Company and Transitory
Subsidiary, to hold such Shares subject to all terms and
conditions of this Agreement.
(b) Noteholder understands and agrees
that if Noteholder attempts to Transfer, vote or provide any
other person with the authority to vote any of the Shares other
than in compliance with this Agreement, Merger Partner shall
not, and Noteholder hereby unconditionally and irrevocably
instructs Merger Partner to not, (i) permit any such
Transfer on its books and records, (ii) issue a new
certificate representing
A-85
any of the Shares or (iii) record such vote, in each case,
unless and until Noteholder shall have complied with the terms
of this Agreement.
(c) Except as otherwise permitted by this
Agreement or by order of a court of competent jurisdiction,
Noteholder will not commit any act that could restrict or affect
Noteholders legal power, authority and right to vote all
of the Shares then owned of record or beneficially by Noteholder
or otherwise prevent or disable Noteholder from performing any
of his, her or its obligations under this Agreement. Without
limiting the generality of the foregoing, except for this
Agreement and as otherwise permitted by this Agreement,
Noteholder will not enter into any voting agreement with any
person or entity with respect to any of the Shares, grant any
person or entity any proxy (revocable or irrevocable) or power
of attorney with respect to any of the Shares, deposit any of
the Shares in a voting trust or otherwise enter into any
agreement or arrangement with any person or entity limiting or
affecting Noteholders legal power, authority or right to
vote the Shares in favor of the approval of the Proposed
Transaction.
4. Agreement to Vote Shares.
(a) Prior to the Expiration Date, at
every meeting of the stockholders of Merger Partner called, and
at every adjournment or postponement thereof, and on every
action or approval by written consent of the stockholders of
Merger Partner, Noteholder (in Noteholders capacity as
such) shall appear at the meeting or otherwise cause the Shares
to be present thereat for purposes of establishing a quorum and,
to the extent not voted by the persons appointed as proxies
pursuant to this Agreement, vote (i) in favor of adoption
of the Merger Agreement and approval of the transactions
contemplated thereby (collectively, the Proposed
Transaction), (ii) against the approval or
adoption of any proposal made in opposition to, or in
competition with, the Proposed Transaction, and
(iii) against any of the following (to the extent unrelated
to the Proposed Transaction): (A) any merger, consolidation
or business combination involving Merger Partner or any of its
subsidiaries other than the Proposed Transaction; (B) any
sale, lease or transfer of all or substantially all of the
assets of Merger Partner or any of its subsidiaries;
(C) any reorganization, recapitalization, dissolution,
liquidation or winding up of Merger Partner or any of its
subsidiaries; or (D) any other action that is intended, or
could reasonably be expected, to result in a breach of any
covenant, representation or warranty or any other obligation or
agreement of Merger Partner under the Merger Agreement or of
Noteholder under this Agreement or otherwise impede, interfere
with, delay, postpone, discourage or adversely affect the
consummation of the Proposed Transaction (each of (ii) and
(iii), a Competing Transaction).
(b) If Noteholder is the beneficial
owner, but not the record holder, of the Shares, Noteholder
agrees to take all actions necessary to cause the record holder
and any nominees to vote all of the Shares in accordance with
Section 4(a).
5. Grant of Irrevocable
Proxy.
(a) Noteholder hereby irrevocably (to the
fullest extent permitted by law) grants to, and appoints, Public
Company and each of its executive officers and any of them, in
their capacities as officers of Public Company (the
Grantees), as Noteholders proxy and
attorney-in-fact (with full power of substitution and
re-substitution), for and in the name, place and stead of
Noteholder, to vote the Shares, to instruct nominees or record
holders to vote the Shares, or grant a consent or approval in
respect of such Shares in accordance with Section 4 hereof
and, in the discretion of the Grantees with respect to any
proposed adjournments or postponements of any meeting of
Noteholders at which any of the matters described in
Section 4 hereof is to be considered.
(b) Noteholder represents that any
proxies heretofore given in respect of the Shares that may still
be in effect are not irrevocable, and such proxies are hereby
revoked.
(c) Noteholder hereby affirms that the
irrevocable proxy set forth in this Section 5 is given in
connection with the execution of the Merger Agreement, and that
such irrevocable proxy is given to secure the performance of the
duties of Noteholder under this Agreement. Noteholder hereby
further affirms that the irrevocable proxy is coupled with an
interest and may under no circumstances be revoked. Noteholder
hereby ratifies and confirms all that such irrevocable proxy may
lawfully do or cause to be done by virtue hereof.
A-86
Such irrevocable proxy is executed and intended to be
irrevocable in accordance with the provisions of
Section 212 of the Delaware General Corporation Law.
(d) The Grantees may not exercise this
irrevocable proxy on any other matter except as provided above.
Noteholder may vote the Shares on all other matters.
(e) Public Company may terminate this
proxy with respect to Noteholder at any time at its sole
election by written notice provided to Noteholder.
6. No
Solicitation. Noteholder, in his, her or its
capacity as a Noteholder, shall not directly or indirectly,
(a) solicit, initiate, encourage, induce or facilitate the
making, submission or announcement of any Acquisition Proposal
or take any action that could reasonably be expected to lead to
an Acquisition Proposal, (b) furnish any information with
respect to or in connection with or in response to an
Acquisition Proposal or an inquiry or indication of interest
that could reasonably be expected to lead to an Acquisition
Proposal, (c) engage in discussions or negotiations with
any person with respect to any Acquisition Proposal,
(d) approve, endorse or recommend any Acquisition Proposal
or (e) enter into any letter of intent or similar document
or any contract contemplating or otherwise relating to any
Acquisition Proposal.
7. Lock-Up
With Respect to Public Company Common Stock.
Noteholder shall not during the period commencing upon the
Effective Time and ending 180 days after the date on which
the Effective Time occurs, Transfer any shares of Public Company
Common Stock or any securities convertible into or exercisable
or exchangeable for Public Company Common Stock. The foregoing
sentence shall not apply to (a) transactions relating to
shares of Public Company Common Stock or other securities
acquired in open market transactions after the Effective Time;
provided that no filing under Section 16(a) of the
Exchange Act shall be required or shall be voluntarily made in
connection with subsequent sales of shares of Public Company
Common Stock acquired in such open market transactions;
(b) transfers of shares of Public Company Common Stock as a
bona fide gift; (c) distributions of shares of Public
Company Common Stock to limited partners, members or
shareholders of the Noteholder; (d) transfers to any family
limited partnership or family limited liability company whose
partnership or equity interests are owned by, or a trust for the
direct or indirect benefit of, or controlled by, the Noteholder
or the immediate family of the Noteholder; (e) transfers to
the Noteholders Affiliates or to any investment fund or
other entity controlled or managed by the Noteholder;
provided that in the case of any transfer or distribution
pursuant to clause (b), (c), (d) or (e), (i) each
donee, distributee or transferee shall sign and deliver a
lock-up
letter containing substantially similar provisions as are set
forth in this Section 7 and (ii) no filing under
Section 16(a) of the Exchange Act, reporting a reduction in
beneficial ownership of shares of Public Company Common Stock,
shall be required or shall be voluntarily made during the
restricted period referred to in the foregoing sentence; or
(f) transfers to any beneficiary of the Noteholder pursuant
to will, intestacy or other testamentary document or applicable
laws of descent. In addition, the Noteholder agrees that,
without the prior written consent of Public Company, it will
not, during the period commencing on the Effective Time and
ending 180 days after the date on which the Effective Time
occurs, make any demand for or exercise any right with respect
to, the registration of any shares of Public Company Common
Stock or any securities convertible into or exercisable or
exchangeable for Public Company Common Stock. The Noteholder
also agrees and consents to the entry of stop transfer
instructions with Public Companys transfer agent and
registrar against the transfer of the undersigneds shares
of Public Company Common Stock or any securities convertible
into or exercisable or exchangeable for Public Company Common
Stock except in compliance with the foregoing restrictions.
8. Action in Noteholder Capacity
Only. Noteholder makes no agreement or
understanding herein as a director or officer of Merger Partner.
Noteholder signs solely in Noteholders capacity as a
record holder and beneficial owner, as applicable, of Shares,
and nothing herein shall limit or affect any actions taken in
Noteholders capacity as an officer or director of Merger
Partner.
9. Representations and
Warranties of Noteholder.
(a) Noteholder hereby represents and
warrants to Public Company as follows: (i) Noteholder is
the beneficial or record owner of the shares of capital stock of
Merger Partner indicated on
A-87
the signature page of this Agreement free and clear of any and
all pledges, liens, security interests, mortgage, claims,
charges, restrictions, options, title defects or encumbrances;
(ii) Noteholder does not beneficially own any securities of
Merger Partner other than the shares of capital stock and rights
to purchase shares of capital stock of Merger Partner set forth
on the signature page of this Agreement; (iii) Noteholder
has full power and authority to make, enter into and carry out
the terms of this Agreement and to grant the irrevocable proxy
as set forth in Section 5; and (iv) this Agreement has
been duly and validly executed and delivered by Noteholder and
constitutes a valid and binding agreement of Noteholder
enforceable against Noteholder in accordance with its terms.
Noteholder agrees to notify Public Company promptly of any
additional shares of capital stock of Merger Partner of which
Noteholder becomes the beneficial owner after the date of this
Agreement.
(b) As of the date hereof and for so long
as this Agreement remains in effect, except for this Agreement
or as otherwise permitted by this Agreement, Noteholder has full
legal power, authority and right to vote all of the Shares then
owned of record or beneficially by Noteholder, in favor of the
approval and authorization of the Proposed Transaction without
the consent or approval of, or any other action on the part of,
any other person or entity (including, without limitation, any
governmental entity). Without limiting the generality of the
foregoing, Noteholder has not entered into any voting agreement
(other than this Agreement) with any person with respect to any
of the Shares, granted any person any proxy (revocable or
irrevocable) or power of attorney with respect to any of the
Shares, deposited any of the Shares in a voting trust or entered
into any arrangement or agreement with any person limiting or
affecting Noteholders legal power, authority or right to
vote the Shares on any matter.
(c) The execution and delivery of this
Agreement and the performance by Noteholder of his, her or its
agreements and obligations hereunder will not result in any
breach or violation of or be in conflict with or constitute a
default under any term of any agreement, judgment, injunction,
order, decree, law, regulation or arrangement to which
Noteholder is a party or by which Noteholder (or any of his, her
or its assets) is bound, except for any such breach, violation,
conflict or default which, individually or in the aggregate,
would not impair or adversely affect Noteholders ability
to perform his, her or its obligations under this Agreement or
render inaccurate any of the representations made by Noteholder
herein.
(d) Except as disclosed pursuant to the
Merger Agreement, no investment banker, broker, finder or other
intermediary is entitled to a fee or commission from Public
Company, the Transitory Subsidiary or Merger Partner in respect
of this Agreement based upon any arrangement or agreement made
by or on behalf of Noteholder.
(e) Noteholder understands and
acknowledges that Public Company, the Transitory Subsidiary and
Merger Partner are entering into the Merger Agreement in
reliance upon Noteholders execution and delivery of this
Agreement and the representations and warranties of Noteholder
contained herein.
10. Exchange of Shares; Waiver of
Rights of Appraisal. If the Merger is
consummated, the Shares shall, pursuant to the terms of the
Merger Agreement, be exchanged for the consideration provided in
the Merger Agreement. Noteholder hereby waives, and agrees to
prevent the exercise of, any rights of appraisal with respect to
the Merger, or rights to dissent from the Merger, that such
Noteholder may have by virtue of his, her or its beneficial
ownership of the Shares.
11. Confidentiality.
Noteholder recognizes that successful consummation of the
Proposed Transaction may be dependent upon confidentiality with
respect to the matters referred to herein. In this connection,
pending public disclosure thereof, and so that Public Company
may rely on the safe harbor provisions of
Rule 100(b)(2)(ii) of Regulation FD promulgated under
the Exchange Act, Noteholder hereby agrees not to disclose or
discuss such matters with anyone not a party to this Agreement
(other than its counsel and advisors, if any) without the prior
written consent of Public Company and Merger Partner, except for
disclosures Noteholders counsel advises are required by
applicable law, in which case Noteholder shall give notice of
such disclosure to Public Company and Merger Partner as promptly
as practicable so as to
A-88
enable Public Company and Merger Partner to seek a protective
order from a court of competent jurisdiction with respect
thereto.
12. Termination. This
Agreement, other than Sections 7 and 13 hereof, shall
terminate and be of no further force or effect whatsoever as of
the earlier of (a) such date and time as the Merger
Agreement shall have been validly terminated pursuant to the
terms of Article 8 thereof or (b) the Effective Time
(the Expiration Date). Notwithstanding
anything in this Agreement to the contrary, Sections 7 and
13 hereof shall remain in full force and effect following the
Effective Time for the time period provided in Section 7.
13. Miscellaneous
Provisions.
(a) Amendments, Modifications and
Waivers. This Agreement may not be amended or
modified except by an instrument in writing signed on behalf of
each of the parties hereto. Any agreement on the part of a party
hereto to any waiver of any term or condition hereof shall be
valid only if set forth in a written instrument signed on behalf
of such party. Such waiver shall not be deemed to apply to any
term or condition other than that which is specified in such
waiver. The failure of any party to this Agreement to assert any
of its rights under this Agreement or otherwise shall not
constitute a waiver of such rights.
(b) Entire Agreement.
This Agreement constitutes the entire agreement among the
parties to this Agreement and supersedes any prior
understandings, agreements or representations by or among the
parties hereto, or any of them, written or oral, with respect to
the subject matter hereof.
(c) Governing Law. All
matters arising out of or relating to this Agreement and the
transactions contemplated hereby (including without limitation
its interpretation, construction, performance and enforcement)
shall be governed by and construed in accordance with the
internal laws of the State of Delaware without giving effect to
any choice or conflict of law provision or rule (whether of the
State of Delaware or any other jurisdiction) that would cause
the application of laws of any jurisdictions other than those of
the State of Delaware.
(d) Submission to
Jurisdiction. Each of the parties to this
Agreement (i) consents to submit itself to the exclusive
personal jurisdiction of the Court of Chancery of the State of
Delaware in any action or proceeding arising out of or relating
to this Agreement or any of the transactions contemplated by
this Agreement, (ii) agrees that all claims in respect of
such action or proceeding may be heard and determined in such
court, (iii) agrees that it shall not attempt to deny or
defeat such personal jurisdiction by motion or other request for
leave from such court and (d) agrees not to bring any
action or proceeding arising out of or relating to this
Agreement or any of the transaction contemplated by this
Agreement in any other court. Each of the parties hereto waives
any defense of inconvenient forum to the maintenance of any
action or proceeding so brought and waives any bond, surety or
other security that might be required of any other party with
respect thereto. Any party may make service on another party by
sending or delivering a copy of the process to the party to be
served at the address and in the manner provided for the giving
of notices in Section 13(m) hereof. Nothing in this
Section 13(d), however, shall affect the right of any party
to serve legal process in any other manner permitted by law.
(e) WAIVER OF JURY
TRIAL. EACH OF THE PARTIES HERETO HEREBY
IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION,
PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR
OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE
TRANSACTIONS CONTEMPLATED HEREBY OR THE ACTIONS OF ANY PARTY IN
THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT OF
THIS AGREEMENT.
(f) Attorneys
Fees. In any action at law or suit in equity to
enforce this Agreement or the rights of any of the parties
hereunder, the prevailing party in such action or suit shall be
entitled to receive its reasonable attorneys fees and all
other reasonable costs and expenses incurred in such action or
suit.
(g) Assignment and
Successors. No party may assign any of its
rights or delegate any of its performance obligations under this
Agreement, in whole or in part, by operation of law or otherwise
without the prior written consent of the other parties, except
that Public Company, without obtaining the consent of any other
parties hereto, shall be entitled to assign this Agreement or
all or any of its rights or
A-89
obligations hereunder to any one or more of its Affiliates. No
assignment by Public Company under this Section 13(g) shall
relieve Public Company of its obligations under this Agreement.
Subject to the foregoing, this Agreement shall be binding upon,
inure to the benefit of, and be enforceable by, the parties
hereto and their respective successors and permitted assigns,
including, without limitation, Noteholders estate and
heirs upon the death of Noteholder. Any purported assignment of
rights or delegation of performance obligations in violation of
this Section 13(g) shall be null and void.
(h) No Third Party
Beneficiaries. This Agreement is not intended,
and shall not be deemed, to confer any rights or remedies upon
any person other than the parties hereto and their respective
successors and permitted assigns, or to otherwise create any
third-party beneficiary hereto.
(i) Cooperation.
Noteholder agrees to cooperate fully with Public Company and to
execute and deliver such further documents, certificates,
agreements and instruments and to take such other actions as may
be reasonably requested by Public Company to evidence or reflect
the transactions contemplated by this Agreement and to carry out
the intent and purpose of this Agreement. Noteholder hereby
agrees that Public Company and Merger Partner may publish and
disclose in the Registration Statement and any resale
registration statement relating thereto (including all documents
and schedules filed with the SEC) and the Proxy
Statement/Prospectus, such Noteholders identity and
ownership of Shares and the nature of such Noteholders
commitments, arrangements and understandings under this
Agreement and may further file this Agreement as an exhibit to
the Registration Statement or in any other filing made by Public
Company or Merger Partner with the SEC relating to the Proposed
Transaction.
(j) Severability. Any
term or provision of this Agreement that is invalid or
unenforceable in any situation in any jurisdiction shall not
affect the validity or enforceability of the remaining terms and
provisions hereof or the validity or enforceability of the
offending term or provision in any other situation or in any
other jurisdiction. If the final judgment of a court of
competent jurisdiction declares that any term or provision
hereof is invalid or unenforceable, the parties hereto agree
that the court making such determination shall have the power to
limit the term or provision, to delete specific words or
phrases, or to replace any invalid or unenforceable term or
provision with a term or provision that is valid and enforceable
and that comes closest to expressing the intention of the
invalid or unenforceable term or provision, and this Agreement
shall be enforceable as so modified. In the event such court
does not exercise the power granted to it in the prior sentence,
the parties hereto agree to replace such invalid or
unenforceable term or provision with a valid and enforceable
term or provision that will achieve, to the extent possible, the
economic, business and other purposes of such invalid or
unenforceable term.
(k) Time of Essence.
With regard to all dates and time periods set forth or referred
to in this Agreement, time is of the essence.
(l) Specific Performance; Injunctive
Relief. The parties hereto acknowledge that
Public Company and Merger Partner shall be irreparably harmed
and that there shall be no adequate remedy at law for a
violation of any of the covenants or agreements of Noteholder
set forth in this Agreement. Noteholder accordingly agrees that,
in addition to any other remedies that may be available to
Public Company or Merger Partner, as applicable upon any such
violation, such party shall have the right to enforce such
covenants and agreements by specific performance, injunctive
relief or by any other means available to such party at law or
in equity without posting any bond or other undertaking.
(m) Notices. All
notices and other communications hereunder shall be in writing
and shall be deemed duly delivered (i) four business days
after being sent by registered or certified mail, return receipt
requested, postage prepaid, or (ii) one business day after
being sent for next business day delivery, fees prepaid, via a
reputable nationwide overnight courier service, in each case to
the intended recipient as follows: (A) if to Public Company
or Merger Partner, to the address provided in the Merger
Agreement, including to the persons designated therein to
receive copies, and (B) if to Noteholder, to
Noteholders address shown below Noteholders
signature on the signature page hereof.
(n) Counterparts and
Signature. This Agreement may be executed in two
or more counterparts, each of which shall be deemed an original
but all of which together shall be considered one and
A-90
the same agreement and shall become effective when counterparts
have been signed by each of the parties hereto and delivered to
the other parties, it being understood that all parties need not
sign the same counterpart. The exchange of copies of this
Agreement of amendments thereto and of signature pages by
facsimile transmission or by email transmission in portable
document format, or similar format, shall constitute effective
execution and delivery of such instrument(s) as to the parties
and may be used in lieu of the original Agreement for all
purposes. Signatures of the parties transmitted by facsimile or
by email transmission in portable document format, or similar
format, shall be deemed to be their original signatures for all
purposes.
(o) Headings. The
headings contained in this Agreement are for convenience of
reference only and shall not affect in any way the meaning or
interpretation of this Agreement.
(p) Legal
Representation. This Agreement was negotiated by
the parties with the benefit of legal representation and any
rule of construction or interpretation otherwise requiring this
Agreement to be construed or interpreted against any party shall
not apply to any construction or interpretation thereof.
A-91
IN WITNESS WHEREOF, the undersigned have caused this Agreement
to be duly executed as of the date first written above.
|
|
|
CRITICAL THERAPEUTICS, INC.:
|
|
NOTEHOLDER:
|
|
|
|
|
|
CAROLINA PHARMACEUTICALS LTD.
|
|
|
|
|
|
|
Name:
|
|
Name: Craig A. Collard
|
Title:
|
|
Title:
|
|
|
|
|
|
Address:
|
|
|
|
|
|
2000 Regency Parkway, Suite 255
Cary, NC 27518
|
|
|
|
|
|
Telephone: (919) 678-6611
|
|
|
Facsimile: (919) 678-6537
|
|
|
E-Mail Address: ccollard@cornerstonebiopharma.com
|
|
|
|
|
|
Shares Beneficially Owned by Noteholder:
|
|
|
|
|
|
shares
of Merger Partner Common Stock
|
|
|
|
|
|
Merger
Partner Stock Options
|
|
|
|
|
|
Merger
Partner Warrants
|
[Signature
Page to Merger Partner Noteholder Agreement]
A-92
CORNERSTONE BIOPHARMA HOLDINGS, INC.:
Name: Craig A. Collard
|
|
Title: |
President and Chief Executive Officer
|
CORNERSTONE BIOPHARMA, INC.:
Name: Craig A. Collard
|
|
Title: |
President and Chief Executive Officer
|
[Signature
Page to Merger Partner Noteholder Agreement]
A-93
EXHIBIT A-3
PUBLIC
COMPANY
STOCKHOLDER
AGREEMENT
THIS STOCKHOLDER AGREEMENT (this Agreement),
dated as of May , 2008, is by and among
Cornerstone BioPharma Holdings, Inc., a Delaware corporation
(Merger Partner), Critical Therapeutics,
Inc., a Delaware corporation (Public Company)
(only with respect to Section 2(b) hereof), and the
undersigned stockholders (each, a Stockholder
and, together, the Stockholders) of Public
Company.
WHEREAS, concurrently with the execution and delivery of this
Agreement, Public Company, Neptune Acquisition Corp., a Delaware
corporation and a wholly owned subsidiary of Public Company (the
Transitory Subsidiary), and Merger Partner
have entered into an Agreement and Plan of Merger, dated as of
the date hereof (as it may be amended or supplemented from time
to time pursuant to the terms thereof, the Merger
Agreement), which provides for the merger (the
Merger) of the Transitory Subsidiary into
Merger Partner in accordance with the terms of the Merger
Agreement;
WHEREAS, the Stockholders are the beneficial owners (as defined
in
Rule 13d-3
under the Exchange Act) of such number of shares of each class
of capital stock of Public Company as is indicated on the
signature page of this Agreement; and
WHEREAS, in consideration of the execution and delivery of the
Merger Agreement by Merger Partner, each Stockholder desires to
agree to vote the Shares (as defined herein) over which
Stockholder has voting power so as to facilitate the
consummation of the Merger;
NOW, THEREFORE, in consideration of the foregoing, intending to
be legally bound, the parties hereto hereby agree as follows:
1. Certain
Definitions.
(a) Capitalized terms used but not
otherwise defined herein shall have the meanings ascribed
thereto in the Merger Agreement. For purposes of this Agreement,
the following terms shall have the following meanings:
Constructive Sale means with respect to any
security, a short sale with respect to such security, entering
into or acquiring an offsetting derivative contract with respect
to such security, entering into or acquiring a futures or
forward contract to deliver such security or entering into any
other hedging or other derivative transaction that has the
effect of either directly or indirectly materially changing the
economic benefits or risks of ownership.
Shares means (i) all shares of capital
stock of Public Company owned, beneficially or of record, by
each Stockholder as of the date hereof, and (ii) all
additional shares of capital stock of Public Company acquired by
each Stockholder, beneficially or of record, during the period
commencing with the execution and delivery of this Agreement and
expiring on the Expiration Date (as such term is defined in
Section 9 below).
Transfer means, with respect to any security,
the direct or indirect assignment, sale, transfer, tender,
exchange, pledge, hypothecation, or the grant, creation or
suffrage of a lien, security interest or encumbrance in or upon,
or the gift, placement in trust, or the Constructive Sale or
other disposition of such security (including transfers by
testamentary or intestate succession or otherwise by operation
of law) or any right, title or interest therein (including, but
not limited to, any right or power to vote to which the holder
thereof may be entitled, whether such right or power is granted
by proxy or otherwise), or the record or beneficial ownership
thereof, the offer to make such a sale, transfer, Constructive
Sale or other disposition, and each agreement, arrangement or
understanding, whether or not in writing, to effect any of the
foregoing.
A-94
2. Transfer and Voting
Restrictions With Respect to the Shares.
(a) At all times during the period
commencing with the execution and delivery of this Agreement and
expiring on the Expiration Date, no Stockholder shall, except in
connection with the Merger or as the result of the death of
Stockholder, Transfer any of the Shares, or discuss, negotiate,
make an offer or enter into an agreement, commitment or other
arrangement with respect thereto, unless the person to which
such Shares are being Transferred shall have executed and
delivered a counterpart of this Agreement and agreed pursuant
thereto, for the benefit of Merger Partner, to hold such Shares
subject to all terms and conditions of this Agreement.
(b) Each Stockholder understands and
agrees that if Stockholder attempts to Transfer, vote or provide
any other person with the authority to vote any of the Shares
other than in compliance with this Agreement, Public Company
shall not, and Stockholder hereby unconditionally and
irrevocably instructs Public Company to not, (i) permit any
such Transfer on its books and records, (ii) issue a new
certificate representing any of the Shares or (iii) record
such vote, in each case, unless and until Stockholder shall have
complied with the terms of this Agreement.
(c) Except as otherwise permitted by this
Agreement or by order of a court of competent jurisdiction, no
Stockholder will commit any act that could restrict or affect
Stockholders legal power, authority and right to vote all
of the Shares then owned of record or beneficially by
Stockholder or otherwise prevent or disable Stockholder from
performing any of his, her or its obligations under this
Agreement. Without limiting the generality of the foregoing,
except for this Agreement and as otherwise permitted by this
Agreement, no Stockholder will enter into any voting agreement
with any person or entity with respect to any of the Shares,
grant any person or entity any proxy (revocable or irrevocable)
or power of attorney with respect to any of the Shares, deposit
any of the Shares in a voting trust or otherwise enter into any
agreement or arrangement with any person or entity limiting or
affecting Stockholders legal power, authority or right to
vote the Shares in favor of the approval of the Proposed
Transaction.
3. Agreement to Vote
Shares.
(a) Prior to the Expiration Date, at
every meeting of the stockholders of Public Company called, and
at every adjournment or postponement thereof, and on every
action or approval by written consent of the stockholders of
Public Company, each Stockholder (in Stockholders capacity
as such) shall appear at the meeting or otherwise cause the
Shares to be present thereat for purposes of establishing a
quorum and, to the extent not voted by the persons appointed as
proxies pursuant to this Agreement, vote (i) in favor of
the issuance of shares of Public Company Common Stock in the
Merger (the Proposed Transaction),
(ii) against the approval or adoption of any proposal made
in opposition to, or in competition with, the Proposed
Transaction, and (iii) against any of the following (to the
extent unrelated to the Proposed Transaction): (A) any
merger, consolidation or business combination involving Public
Company or any of its subsidiaries other than the Proposed
Transaction; (B) any sale, lease or transfer of all or
substantially all of the assets of Public Company or any of its
subsidiaries; (C) any reorganization, recapitalization,
dissolution, liquidation or winding up of Public Company or any
of its subsidiaries; or (D) any other action that is
intended, or could reasonably be expected, to result in a breach
of any covenant, representation or warranty or any other
obligation or agreement of Public Company under the Merger
Agreement or of Stockholder under this Agreement or otherwise
impede, interfere with, delay, postpone, discourage or adversely
affect the consummation of the Proposed Transaction (each of
(ii) and (iii), a Competing Transaction).
(b) If a Stockholder is the beneficial
owner, but not the record holder, of the Shares, such
Stockholder agrees to take all actions necessary to cause the
record holder and any nominees to vote all of the Shares in
accordance with Section 3(a).
4. Grant of Irrevocable
Proxy.
(a) Each Stockholder hereby irrevocably
(to the fullest extent permitted by law) grants to, and
appoints, Merger Partner and each of its executive officers and
any of them, in their capacities as officers of Merger Partner
(the Grantees), as Stockholders proxy
and attorney-in-fact (with full power of substitution and
re-substitution), for and in the name, place and stead of
Stockholder, to vote the Shares, to
A-95
instruct nominees or record holders to vote the Shares, or grant
a consent or approval in respect of such Shares in accordance
with Section 3 hereof and, in the discretion of the
Grantees with respect to any proposed adjournments or
postponements of any meeting of stockholders at which any of the
matters described in Section 3 hereof is to be considered.
(b) Each Stockholder represents that any
proxies heretofore given in respect of the Shares that may still
be in effect are not irrevocable, and such proxies are hereby
revoked.
(c) Each Stockholder hereby affirms that
the irrevocable proxy set forth in this Section 4 is given
in connection with the execution of the Merger Agreement, and
that such irrevocable proxy is given to secure the performance
of the duties of Stockholder under this Agreement. Each
Stockholder hereby further affirms that the irrevocable proxy is
coupled with an interest and may under no circumstances be
revoked. Each Stockholder hereby ratifies and confirms all that
such irrevocable proxy may lawfully do or cause to be done by
virtue hereof. Such irrevocable proxy is executed and intended
to be irrevocable in accordance with the provisions of
Section 212 of the Delaware General Corporation Law.
(d) The Grantees may not exercise this
irrevocable proxy on any other matter except as provided above.
Stockholders may vote the Shares on all other matters.
(e) Merger Partner may terminate this
proxy with respect to any Stockholder at any time at its sole
election by written notice provided to such Stockholder.
5. No
Solicitation. No Stockholder, in his, her or its
capacity as a Stockholder, shall directly or indirectly,
(a) solicit, initiate, encourage, induce or facilitate the
making, submission or announcement of any Acquisition Proposal
or take any action that could reasonably be expected to lead to
an Acquisition Proposal, (b) furnish any information with
respect to or in connection with or in response to an
Acquisition Proposal or an inquiry or indication of interest
that could reasonably be expected to lead to an Acquisition
Proposal, (c) engage in discussions or negotiations with
any person with respect to any Acquisition Proposal,
(d) approve, endorse or recommend any Acquisition Proposal
or (e) enter into any letter of intent or similar document
or any contract contemplating or otherwise relating to any
Acquisition Proposal.
6. Action in Stockholder
Capacity Only. No Stockholder makes any
agreement or understanding herein as a director or officer of
Public Company. Each Stockholder signs solely in
Stockholders capacity as a record holder and beneficial
owner, as applicable, of Shares, and nothing herein shall limit
or affect any actions taken in Stockholders capacity as an
officer or director of Public Company.
7. Representations and
Warranties of Stockholder.
(a) Each Stockholder hereby represents
and warrants to Merger Partner as follows: (i) Stockholder
is the beneficial or record owner of the shares of capital stock
of Public Company indicated on the signature page of this
Agreement free and clear of any and all pledges, liens, security
interests, mortgage, claims, charges, restrictions, options,
title defects or encumbrances; (ii) Stockholder does not
beneficially own any securities of Public Company other than the
shares of capital stock and rights to purchase shares of capital
stock of Public Company set forth on the signature page of this
Agreement; (iii) Stockholder has full power and authority
to make, enter into and carry out the terms of this Agreement
and to grant the irrevocable proxy as set forth in
Section 4; and (iv) this Agreement has been duly and
validly executed and delivered by Stockholder and constitutes a
valid and binding agreement of Stockholder enforceable against
Stockholder in accordance with its terms. Each Stockholder
agrees to notify Merger Partner promptly of any additional
shares of capital stock of Public Company of which Stockholder
becomes the beneficial owner after the date of this Agreement.
(b) As of the date hereof and for so long
as this Agreement remains in effect, except for this Agreement
or as otherwise permitted by this Agreement, each Stockholder
has full legal power, authority and right to vote all of the
Shares then owned of record or beneficially by Stockholder, in
favor of the approval and authorization of the Proposed
Transaction without the consent or approval of, or any other
action on the part of, any other person or entity (including,
without limitation, any governmental entity). Without limiting
the generality of the foregoing, no Stockholder has entered into
any voting agreement (other than this
A-96
Agreement) with any person with respect to any of the Shares,
granted any person any proxy (revocable or irrevocable) or power
of attorney with respect to any of the Shares, deposited any of
the Shares in a voting trust or entered into any arrangement or
agreement with any person limiting or affecting
Stockholders legal power, authority or right to vote the
Shares on any matter.
(c) The execution and delivery of this
Agreement and the performance by each Stockholder of his, her or
its agreements and obligations hereunder will not result in any
breach or violation of or be in conflict with or constitute a
default under any term of any agreement, judgment, injunction,
order, decree, law, regulation or arrangement to which
Stockholder is a party or by which Stockholder (or any of his,
her or its assets) is bound, except for any such breach,
violation, conflict or default which, individually or in the
aggregate, would not impair or adversely affect
Stockholders ability to perform his, her or its
obligations under this Agreement or render inaccurate any of the
representations made by Stockholder herein.
(d) Except as disclosed pursuant to the
Merger Agreement, no investment banker, broker, finder or other
intermediary is entitled to a fee or commission from Public
Company, the Transitory Subsidiary or Merger Partner in respect
of this Agreement based upon any arrangement or agreement made
by or on behalf of any Stockholder.
(e) Each Stockholder understands and
acknowledges that Public Company, the Transitory Subsidiary and
Merger Partner are entering into the Merger Agreement in
reliance upon Stockholders execution and delivery of this
Agreement and the representations and warranties of Stockholder
contained herein.
8. Confidentiality.
Each Stockholder recognizes that successful consummation of the
Proposed Transaction may be dependent upon confidentiality with
respect to the matters referred to herein. In this connection,
pending public disclosure thereof, and so that Public Company
may rely on the safe harbor provisions of
Rule 100(b)(2)(ii) of Regulation FD promulgated under
the Exchange Act, each Stockholder hereby agrees not to disclose
or discuss such matters with anyone not a party to this
Agreement (other than its counsel and advisors, if any) without
the prior written consent of Public Company and Merger Partner,
except for disclosures Stockholders counsel advises are
required by applicable law, in which case Stockholder shall give
notice of such disclosure to Public Company and Merger Partner
as promptly as practicable so as to enable Public Company and
Merger Partner to seek a protective order from a court of
competent jurisdiction with respect thereto.
9. Termination.
This Agreement shall terminate and be of no further force or
effect whatsoever as of the earlier of (a) such date and
time as the Merger Agreement shall have been validly terminated
pursuant to the terms of Article 8 thereof or (b) the
Effective Time (the Expiration Date).
10. Miscellaneous
Provisions.
(a) Amendments, Modifications and
Waivers. This Agreement may not be amended or
modified except by an instrument in writing signed on behalf of
each of the parties hereto. Any agreement on the part of a party
hereto to any waiver of any term or condition hereof shall be
valid only if set forth in a written instrument signed on behalf
of such party. Such waiver shall not be deemed to apply to any
term or condition other than that which is specified in such
waiver. The failure of any party to this Agreement to assert any
of its rights under this Agreement or otherwise shall not
constitute a waiver of such rights.
(b) Entire Agreement.
This Agreement constitutes the entire agreement among the
parties to this Agreement and supersedes any prior
understandings, agreements or representations by or among the
parties hereto, or any of them, written or oral, with respect to
the subject matter hereof.
(c) Governing Law. All
matters arising out of or relating to this Agreement and the
transactions contemplated hereby (including without limitation
its interpretation, construction, performance and enforcement)
shall be governed by and construed in accordance with the
internal laws of the State of Delaware without giving effect to
any choice or conflict of law provision or rule (whether of the
State of Delaware or any other jurisdiction) that would cause
the application of laws of any jurisdictions other than those of
the State of Delaware.
A-97
(d) Submission to
Jurisdiction. Each of the parties to this
Agreement (i) consents to submit itself to the exclusive
personal jurisdiction of the Chancery Court of the State of
Delaware in any action or proceeding arising out of or relating
to this Agreement or any of the transactions contemplated by
this Agreement, (ii) agrees that all claims in respect of
such action or proceeding may be heard and determined in such
court, (iii) agrees that it shall not attempt to deny or
defeat such personal jurisdiction by motion or other request for
leave from such court and (d) agrees not to bring any
action or proceeding arising out of or relating to this
Agreement or any of the transaction contemplated by this
Agreement in any other court. Each of the parties hereto waives
any defense of inconvenient forum to the maintenance of any
action or proceeding so brought and waives any bond, surety or
other security that might be required of any other party with
respect thereto. Any party may make service on another party by
sending or delivering a copy of the process to the party to be
served at the address and in the manner provided for the giving
of notices in Section 10(m) hereof. Nothing in this
Section 10(d), however, shall affect the right of any party
to serve legal process in any other manner permitted by law.
(e) WAIVER OF JURY
TRIAL. EACH OF THE PARTIES HERETO HEREBY
IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION,
PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR
OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE
TRANSACTIONS CONTEMPLATED HEREBY OR THE ACTIONS OF ANY PARTY IN
THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT OF
THIS AGREEMENT.
(f) Attorneys
Fees. In any action at law or suit in equity to
enforce this Agreement or the rights of any of the parties
hereunder, the prevailing party in such action or suit shall be
entitled to receive its reasonable attorneys fees and all
other reasonable costs and expenses incurred in such action or
suit.
(g) Assignment and
Successors. No party may assign any of its
rights or delegate any of its performance obligations under this
Agreement, in whole or in part, by operation of law or otherwise
without the prior written consent of the other parties, except
that Merger Partner, without obtaining the consent of any other
parties hereto, shall be entitled to assign this Agreement or
all or any of its rights or obligations hereunder to any one or
more of its Affiliates. No assignment by Merger Partner under
this Section 10(g) shall relieve Merger Partner of its
obligations under this Agreement. Subject to the foregoing, this
Agreement shall be binding upon, inure to the benefit of, and be
enforceable by, the parties hereto and their respective
successors and permitted assigns, including, without limitation,
Stockholders estate and heirs upon the death of
Stockholder. Any purported assignment of rights or delegation of
performance obligations in violation of this Section 10(g)
shall be null and void.
(h) No Third Party
Beneficiaries. This Agreement is not intended,
and shall not be deemed, to confer any rights or remedies upon
any person other than the parties hereto and their respective
successors and permitted assigns, or to otherwise create any
third-party beneficiary hereto.
(i) Cooperation. Each
Stockholder agrees to cooperate fully with Merger Partner and to
execute and deliver such further documents, certificates,
agreements and instruments and to take such other actions as may
be reasonably requested by Merger Partner to evidence or reflect
the transactions contemplated by this Agreement and to carry out
the intent and purpose of this Agreement. Each Stockholder
hereby agrees that Public Company and Merger Partner may publish
and disclose in the Registration Statement and any resale
registration statement relating thereto (including all documents
and schedules filed with the SEC) and the Proxy
Statement/Prospectus, each such Stockholders identity and
ownership of Shares and the nature of such Stockholders
commitments, arrangements and understandings under this
Agreement and may further file this Agreement as an exhibit to
the Registration Statement or in any other filing made by Public
Company or Merger Partner with the SEC relating to the Proposed
Transaction.
(j) Severability. Any
term or provision of this Agreement that is invalid or
unenforceable in any situation in any jurisdiction shall not
affect the validity or enforceability of the remaining terms and
provisions hereof or the validity or enforceability of the
offending term or provision in any other situation or in any
other jurisdiction. If the final judgment of a court of
competent jurisdiction declares that any term or provision
hereof is invalid or unenforceable, the parties hereto agree
that the court making such determination
A-98
shall have the power to limit the term or provision, to delete
specific words or phrases, or to replace any invalid or
unenforceable term or provision with a term or provision that is
valid and enforceable and that comes closest to expressing the
intention of the invalid or unenforceable term or provision, and
this Agreement shall be enforceable as so modified. In the event
such court does not exercise the power granted to it in the
prior sentence, the parties hereto agree to replace such invalid
or unenforceable term or provision with a valid and enforceable
term or provision that will achieve, to the extent possible, the
economic, business and other purposes of such invalid or
unenforceable term.
(k) Time of Essence.
With regard to all dates and time periods set forth or referred
to in this Agreement, time is of the essence.
(l) Specific Performance; Injunctive
Relief. The parties hereto acknowledge that
Public Company and Merger Partner shall be irreparably harmed
and that there shall be no adequate remedy at law for a
violation of any of the covenants or agreements of each
Stockholder set forth in this Agreement. Each Stockholder
accordingly agrees that, in addition to any other remedies that
may be available to Public Company or Merger Partner, as
applicable upon any such violation, such party shall have the
right to enforce such covenants and agreements by specific
performance, injunctive relief or by any other means available
to such party at law or in equity without posting any bond or
other undertaking.
(m) Notices. All
notices and other communications hereunder shall be in writing
and shall be deemed duly delivered (i) four business days
after being sent by registered or certified mail, return receipt
requested, postage prepaid, or (ii) one business day after
being sent for next business day delivery, fees prepaid, via a
reputable nationwide overnight courier service, in each case to
the intended recipient as follows: (A) if to Public Company
or Merger Partner, to the address provided in the Merger
Agreement, including to the persons designated therein to
receive copies, and (B) if to any Stockholder, to such
Stockholders address shown below Stockholders
signature on the signature page hereof.
(n) Counterparts and
Signature. This Agreement may be executed in two
or more counterparts, each of which shall be deemed an original
but all of which together shall be considered one and the same
agreement and shall become effective when counterparts have been
signed by each of the parties hereto and delivered to the other
parties, it being understood that all parties need not sign the
same counterpart. The exchange of copies of this Agreement of
amendments thereto and of signature pages by facsimile
transmission or by email transmission in portable document
format, or similar format, shall constitute effective execution
and delivery of such instrument(s) as to the parties and may be
used in lieu of the original Agreement for all purposes.
Signatures of the parties transmitted by facsimile or by email
transmission in portable document format, or similar format,
shall be deemed to be their original signatures for all purposes.
(o) Headings. The
headings contained in this Agreement are for convenience of
reference only and shall not affect in any way the meaning or
interpretation of this Agreement.
(p) Legal
Representation. This Agreement was negotiated by
the parties with the benefit of legal representation and any
rule of construction or interpretation otherwise requiring this
Agreement to be construed or interpreted against any party shall
not apply to any construction or interpretation thereof.
A-99
IN WITNESS WHEREOF, the undersigned have caused this Agreement
to be duly executed as of the date first written above.
|
|
|
CORNERSTONE BIOPHARMA HOLDINGS, INC.:
|
|
STOCKHOLDER:
|
|
|
|
|
|
|
Name:
|
|
Name:
|
Title:
|
|
[Title:]
|
|
|
|
|
|
Address:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Telephone: ( ) -
|
|
|
Facsimile: ( ) -
|
|
|
E-Mail
Address:
|
|
|
|
|
|
Shares Beneficially Owned by Stockholder:
|
|
|
shares
of Public Company Common Stock
|
|
|
|
|
|
Warrants to acquire
shares of Public Company Common Stock
|
|
|
|
|
|
Options to acquire
shares of Public Company Common Stock
|
[Signature
Page to Public Company Stockholder Agreement]
A-100
With respect to Section 2(b) only:
CRITICAL THERAPEUTICS, INC.:
Name:
[Signature
Page to Public Company Stockholder Agreement]
A-101
EXHIBIT B
CERTIFICATE
OF INCORPORATION
OF
CORNERSTONE
BIOPHARMA HOLDINGS, INC.
FIRST: The name of the Corporation is: Cornerstone
BioPharma Holdings, Inc.
SECOND: The address of the Corporations
registered office in the State of Delaware is Corporation
Trust Center, 1209 Orange Street, in the City of
Wilmington, County of New Castle. The name of its registered
agent at such address is The Corporation Trust Company.
THIRD: The nature of the business or purposes to be
conducted or promoted by the Corporation is to engage in any
lawful act or activity for which corporations may be organized
under the General Corporation Law of the State of Delaware.
FOURTH: The total number of shares of stock which the
Corporation shall have authority to issue is 1,000 shares
of Common Stock, $0.001 par value per share.
The number of authorized shares of Common Stock may be increased
or decreased (but not below the number of shares thereof then
outstanding) by the affirmative vote of the holders of a
majority of the stock of the Corporation entitled to vote,
irrespective of the provisions of Section 242(b)(2) of the
General Corporation Law of the State of Delaware.
FIFTH: In furtherance of and not in limitation of
powers conferred by statute, it is further provided:
1. The business and affairs of the
Corporation shall be managed by or under the direction of the
Board of Directors.
2. Election of directors need not be by
written ballot.
3. The Board of Directors is expressly
authorized to adopt, amend, alter or repeal the Bylaws of the
Corporation.
SIXTH: Except to the extent that the General
Corporation Law of the State of Delaware prohibits the
elimination or limitation of liability of directors for breaches
of fiduciary duty, no director of the Corporation shall be
personally liable to the Corporation or its stockholders for
monetary damages for any breach of fiduciary duty as a director,
notwithstanding any provision of law imposing such liability. No
amendment to or repeal of this provision shall apply to or have
any effect on the liability or alleged liability of any director
of the Corporation for or with respect to any acts or omissions
of such director occurring prior to such amendment.
SEVENTH: The Corporation shall, to the fullest extent
permitted by Section 145 of the General Corporation Law of
the State of Delaware, as amended from time to time, indemnify
each person who was or is a party or is threatened to be made a
party to any threatened, pending or completed action, suit or
proceeding, whether civil, criminal, administrative or
investigative, by reason of the fact that he or she is or was,
or has agreed to become, a director or officer of the
Corporation, or is or was serving, or has agreed to serve, at
the request of the Corporation, as a director, officer, partner,
employee or trustee of, or in a similar capacity with, another
corporation, partnership, joint venture, trust or other
enterprise (including any employee benefit plan) (all such
persons being referred to hereafter as an
Indemnitee), or by reason of any action alleged to
have been taken or omitted in such capacity, against all
expenses (including attorneys fees), judgments, fines and
amounts paid in settlement actually and reasonably incurred by
or on behalf of an Indemnitee in connection with such action,
suit or proceeding and any appeal therefrom.
As a condition precedent to an Indemnitees right to be
indemnified, the Indemnitee must notify the Corporation in
writing as soon as practicable of any action, suit, proceeding
or investigation involving such Indemnitee for which indemnity
will or could be sought. With respect to any action, suit,
proceeding or investigation of which the Corporation is so
notified, the Corporation will be entitled to participate
therein at
A-102
its own expense
and/or to
assume the defense thereof at its own expense, with legal
counsel reasonably acceptable to the Indemnitee.
In the event that the Corporation does not assume the defense of
any action, suit, proceeding or investigation of which the
Corporation receives notice under this Article, the Corporation
shall pay in advance of the final disposition of such matter any
expenses (including attorneys fees) incurred by an
Indemnitee in defending a civil or criminal action, suit,
proceeding or investigation or any appeal therefrom;
provided, however, that the payment of such
expenses incurred by an Indemnitee in advance of the final
disposition of such matter shall be made only upon receipt of an
undertaking by or on behalf of the Indemnitee to repay all
amounts so advanced in the event that it shall ultimately be
determined that the Indemnitee is not entitled to be indemnified
by the Corporation as authorized in this Article, which
undertaking shall be accepted without reference to the financial
ability of the Indemnitee to make such repayment; and
provided, further, that no such advancement of
expenses shall be made under this Article if it is determined
that (i) the Indemnitee did not act in good faith and in a
manner he reasonably believed to be in, or not opposed to, the
best interests of the Corporation, or (ii) with respect to
any criminal action or proceeding, the Indemnitee had reasonable
cause to believe his conduct was unlawful.
The Corporation shall not indemnify an Indemnitee pursuant to
this Article in connection with a proceeding (or part thereof)
initiated by such Indemnitee unless the initiation thereof was
approved by the Board of Directors of the Corporation. In
addition, the Corporation shall not indemnify an Indemnitee to
the extent such Indemnitee is reimbursed from the proceeds of
insurance, and in the event the Corporation makes any
indemnification payments to an Indemnitee and such Indemnitee is
subsequently reimbursed from the proceeds of insurance, such
Indemnitee shall promptly refund such indemnification payments
to the Corporation to the extent of such insurance reimbursement.
All determinations hereunder as to the entitlement of an
Indemnitee to indemnification or advancement of expenses shall
be made in each instance (a) by a majority vote of the
directors of the Corporation consisting of persons who are not
at that time parties to the action, suit or proceeding in
question (disinterested directors), whether or not a
quorum, (b) by a committee of disinterested directors
designated by majority vote of disinterested directors, whether
or not a quorum, (c) if there are no disinterested
directors, or if the disinterested directors so direct, by
independent legal counsel (who may, to the extent permitted by
law, be regular legal counsel to the Corporation) in a written
opinion, or (d) by the stockholders of the Corporation.
The rights provided in this Article (i) shall not be deemed
exclusive of any other rights to which an Indemnitee may be
entitled under any law, agreement or vote of stockholders or
disinterested directors or otherwise, and (ii) shall inure
to the benefit of the heirs, executors and administrators of the
Indemnitees. The Corporation may, to the extent authorized from
time to time by its Board of Directors, grant indemnification
rights to other employees or agents of the Corporation or other
persons serving the Corporation and such rights may be
equivalent to, or greater or less than, those set forth in this
Article.
EIGHTH: The Corporation reserves the right to amend,
alter, change or repeal any provision contained in this
Certificate of Incorporation, in the manner now or hereafter
prescribed by statute and this Certificate of Incorporation, and
all rights conferred upon stockholders herein are granted
subject to this reservation.
A-103
AMENDMENT
NO. 1 TO
AGREEMENT AND PLAN OF MERGER
This Amendment No. 1 (this Amendment
No. 1) to Agreement and Plan of Merger (the
Merger Agreement), dated as of May 1,
2008, among Critical Therapeutics, Inc., a Delaware corporation
(Public Company), Neptune Acquisition Corp.,
a Delaware corporation and a wholly owned subsidiary of Public
Company (the Transitory Subsidiary),
Cornerstone BioPharma Holdings, Inc., a Delaware corporation
(Merger Partner) and, for purposes of
Section 8.3 and 9.13 of the Merger Agreement, Cornerstone
Biopharma, Inc., shall be effective August 7, 2008 (the
Effective Date). Terms that are used herein with
initial capital letters and that are not otherwise defined shall
have the meanings given to them in the Merger Agreement.
BACKGROUND
Public Company, Transitory Subsidiary, Merger Partner, and
Cornerstone Biopharma, Inc. (collectively, the
Parties) previously entered into the Merger
Agreement on May 1, 2008.
Section 3.16(f) of the Merger Agreement erroneously refers
to the product
Tussionex®,
which is owned by UCB Pharma, as being owned by Merger Partner.
The reference in Section 3.16(f) of the Merger Agreement to
Tussionex®
instead should have referred to Merger Partners
extended-release antihistamine and hydrocodone cough suppressant
product candidates that, if approved, will compete with
Tussionex®
in the hydrocodone cough suppressant market.
The Parties desire to amend the Merger Agreement as described
herein.
AGREEMENT
NOW THEREFORE, in consideration of the mutual covenants
contained herein, the Parties agree as follows:
1. Section 3.16(f) of the Merger Agreement is hereby
deleted in its entirety and replaced with a new
Section 3.16(f) that reads as follows:
With respect to each of Merger Partners extended-release
antihistamine and hydrocodone cough suppressant product
candidates, to the knowledge of Merger Partner, no other person
is developing or has developed, or is seeking or has sought FDA
approval of an Abbreviated New Drug Application or a
Supplemental New Drug Application for, a product with the same
or functionally similar active pharmaceutical ingredients for
use for the same or substantially similar indication.
2. The terms and conditions of the Merger Agreement shall
continue in full force and effect except as modified by this
Amendment No. 1.
[signature
page follows]
A-104
[Signature
Page to Amendment No. 1 to Agreement and Plan of
Merger]
IN WITNESS WHEREOF, Public Company, the Transitory Subsidiary,
Merger Partner, and Cornerstone Biopharma, Inc. have caused this
Amendment No. 1 to be signed by their respective officers
thereunto duly authorized as of the Effective Date.
CRITICAL THERAPEUTICS, INC.
Name: Trevor Phillips, Ph.D.
|
|
|
|
Title:
|
President and Chief Executive Officer
|
NEPTUNE ACQUISITION CORP.
Name: Trevor Phillips, Ph.D.
CORNERSTONE BIOPHARMA HOLDINGS, INC.
Name: Craig A. Collard
|
|
|
|
Title:
|
President and Chief Executive Officer
|
CORNERSTONE BIOPHARMA, INC.
Name: Craig A. Collard
|
|
|
|
Title:
|
President and Chief Executive Officer
|
A-105
FOURTH. That, at
5:00 p.m., Eastern time, on the date of filing of this
Certificate of Amendment of the Certificate of Incorporation
with the Secretary of State of the State of Delaware (the
Effective Time), a
one-for- 1
reverse stock split of the Corporations Common Stock shall
become effective, pursuant to which
each 1 shares
of Common Stock issued or outstanding (including treasury
shares) immediately prior to the Effective Time shall be
reclassified and combined into one validly issued, fully paid
and nonassessable share of Common Stock automatically and
without any action by the holder thereof upon the Effective Time
and shall represent one share of Common Stock from and after the
Effective Time (such reclassification and combination of shares
designated as the Reverse Stock Split). The par
value of the Common Stock following the Reverse Stock Split
shall remain at $0.001 per share. No fractional shares of Common
Stock shall be issued as a result of the Reverse Stock Split. In
lieu of any fractional shares to which a stockholder would
otherwise be entitled (after taking into account all fractional
shares of Common Stock otherwise issuable to such holder), the
Corporation shall, upon surrender of such holders
certificate(s) representing such fractional shares of Common
Stock, pay cash in an amount equal to such fractional share of
Common Stock multiplied by the then fair value of the Common
Stock as determined by the Board of Directors.
1 Shall
be a number greater than one and equal to or less than 50 and
shall include not more than three decimal digits. By approving
the Reverse Stock Split, the stockholders of the Corporation are
approving individual amendments to the Certificate of
Incorporation for each number in such range. After the Board of
Directors has selected the number in such range to effect the
Reverse Stock Split, the Corporation will abandon all amendments
to the Certificate of Incorporation except the amendment with
respect to the number selected by the Board of Directors.
B-1
Each stock certificate that,
immediately prior to the Effective Time, represented shares of
Common Stock that were issued and outstanding immediately prior
to the Effective Time shall, from and after the Effective Time,
automatically and without the necessity of presenting the same
for exchange, represent that number of whole shares of Common
Stock after the Effective Time into which the shares formerly
represented by such certificate have been reclassified (as well
as the right to receive cash in lieu of fractional shares of
Common Stock after the Effective Time); provided, however, that
each person of record holding a certificate that represented
shares of Common Stock that were issued and outstanding
immediately prior to the Effective Time shall receive, upon
surrender of such certificate, a new certificate evidencing and
representing the number of whole shares of Common Stock after
the Effective Time into which the shares of Common Stock
formerly represented by such certificate shall have been
reclassified.
The total number of shares of all
classes of stock which the Corporation shall have authority to
issue is Ninety-Five Million (95,000,000) shares, consisting of
(i) Ninety Million (90,000,000) shares of Common Stock, par
value $0.001 per share (the Common Stock), and
(ii) Five Million (5,000,000) shares of Preferred Stock,
par value $0.001 per share (the Preferred
Stock).
Annex C
CERTIFICATE
OF AMENDMENT OF
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF CRITICAL THERAPEUTICS, INC.
PURSUANT
TO SECTION 242 OF THE
GENERAL CORPORATION LAW OF THE STATE OF DELAWARE
Critical Therapeutics, Inc. (the Corporation), a
corporation organized and existing under and by virtue of the
provisions of the General Corporation Law of the State of
Delaware (the General Corporation Law), hereby
certifies as follows:
The Board of Directors of the Corporation pursuant to
Section 242 of the General Corporation Law duly adopted a
resolution setting forth a proposed amendment to the
Corporations Amended and Restated Certificate of
Incorporation (the Certificate of Incorporation) and
declaring such amendment advisable. The stockholders of the
Corporation pursuant to Section 242 of the General
Corporation Law duly approved and adopted such proposed
amendment at a special meeting of stockholders called and held
upon notice in accordance with Section 222 of the General
Corporation Law. Accordingly, to effect such proposed amendment:
Article FIRST of the Certificate of Incorporation is hereby
amended and restated in its entirety to read as follows:
FIRST. The name of the Corporation is Cornerstone
Therapeutics Inc.
Annex D
OPINION
OF LAZARD FRÈRES & CO. LLC
[LETTERHEAD
OF LAZARD FRÈRES & CO. LLC]
May 1,
2008
The Board of Directors
Critical Therapeutics, Inc.
60 Westview Street
Lexington, Massachusetts 02421
Dear Members of the Board:
We understand that Critical Therapeutics, Inc., a Delaware
corporation (Critical Therapeutics), Neptune
Acquisition Corp., a Delaware corporation and wholly owned
subsidiary of Critical Therapeutics (Sub), and
Cornerstone BioPharma Holdings, Inc., a Delaware corporation
(Cornerstone), propose to enter into an Agreement
and Plan of Merger, dated as of May 1, 2008 (the
Agreement), pursuant to which Sub will be merged
with and into Cornerstone (the Transaction).
Pursuant to the Agreement, each outstanding share of the common
stock, par value $0.0001 per share, of Cornerstone
(Cornerstone Common Stock) will be converted into
the right to receive a number of shares of the common stock, par
value $0.001 per share, of Critical Therapeutics (Critical
Therapeutics Common Stock) equal to the product of
(a) 2.3333 multiplied by (b) the quotient of
(i) 43,479,198 divided by (ii) the number of shares of
Cornerstone Common Stock outstanding (or issuable upon exercise
of options and warrants outstanding) immediately prior to the
effective time of the Transaction (the Exchange
Ratio), which Exchange Ratio representatives of Critical
Therapeutics have advised us will result in the stockholders of
Critical Therapeutics and Cornerstone owning 30% and 70%,
respectively, of Critical Therapeutics Common Stock immediately
upon consummation of the Transaction. The Agreement further
provides that, immediately prior to the effective time of the
Transaction, Critical Therapeutics will effect a reverse stock
split of Critical Therapeutics Common Stock pursuant to which
each share of Critical Therapeutics Common Stock then
outstanding will be reclassified and combined into a fractional
number of shares of Critical Therapeutics Common Stock to be
mutually agreed upon by Critical Therapeutics and Cornerstone
(the Reverse Stock Split) and further provides that
the Exchange Ratio will be adjusted to reflect fully the effect
of the Reverse Stock Split. The terms and conditions of the
Transaction are more fully set forth in the Agreement.
You have requested our opinion as of the date hereof as to the
fairness, from a financial point of view, to Critical
Therapeutics of the Exchange Ratio provided for pursuant to the
Agreement.
In connection with this opinion, we have:
|
|
|
|
(i)
|
Reviewed the financial terms and conditions of the Agreement;
|
|
|
(ii)
|
Analyzed certain publicly available historical business and
financial information relating to Critical Therapeutics and
certain historical business and financial information relating
to Cornerstone;
|
|
|
(iii)
|
Reviewed various financial forecasts and other data provided to
us by Critical Therapeutics relating to the business of Critical
Therapeutics and financial forecasts and other data provided to
us by Cornerstone, as adjusted by Critical Therapeutics,
relating to the business of Cornerstone;
|
|
|
(iv)
|
Held discussions with members of the senior managements of
Critical Therapeutics and Cornerstone with respect to the
businesses and prospects of Critical Therapeutics and
Cornerstone, respectively;
|
|
|
(v)
|
Reviewed public information with respect to certain other
companies in lines of business we believe to be generally
relevant in evaluating the businesses of Critical Therapeutics
and Cornerstone, respectively;
|
|
|
(vi)
|
Reviewed historical stock prices and trading volumes of Critical
Therapeutics Common Stock; and
|
|
|
(vii)
|
Conducted such other financial studies, analyses and
investigations as we deemed appropriate.
|
D-1
The Board of Directors
Critical Therapeutics, Inc.
May 1, 2008
Page 2
We have assumed and relied upon the accuracy and completeness of
the foregoing information, without independent verification of
such information. We have not conducted any independent
valuation or appraisal of any of the assets or liabilities
(contingent or otherwise) of Critical Therapeutics or
Cornerstone or concerning the solvency or fair value of Critical
Therapeutics or Cornerstone, and we have not been furnished with
such valuation or appraisal. With respect to the financial
forecasts that we have reviewed (including, in the case of
Cornerstone, adjustments to such forecasts by Critical
Therapeutics), we have assumed, with the consent of Critical
Therapeutics, that they have been reasonably prepared on bases
reflecting the best currently available estimates and judgments
of the managements of Critical Therapeutics and Cornerstone, as
the case may be, as to the future financial performance of
Critical Therapeutics and Cornerstone. We assume no
responsibility for and express no view as to such forecasts or
the assumptions on which they are based. We have relied on the
assessments of the management of Critical Therapeutics as to the
validity of, and risks associated with, the products and product
candidates of Critical Therapeutics and Cornerstone (including,
without limitation, the timing and probability of successful
development, testing and marketing, and of approval by
appropriate governmental authorities, of such products and
product candidates). We have been advised by representatives of
Critical Therapeutics and Cornerstone that a new audit of the
historical financial statements of Cornerstone will be performed
and we have assumed, with the consent of Critical Therapeutics,
that such audited historical financial statements, when
completed, will not vary materially from the audited historical
financial statements of Cornerstone reviewed by us.
Further, our opinion is necessarily based on economic, monetary,
market and other conditions as in effect on, and the information
made available to us as of, the date hereof. We assume no
responsibility for updating or revising our opinion based on
circumstances or events occurring after the date hereof. We do
not express any opinion as to the price at which shares of
Critical Therapeutics Common Stock may trade at any time
subsequent to the announcement of the Transaction.
In rendering our opinion, we have assumed, with the consent of
Critical Therapeutics, that the Transaction and related
transactions (including, without limitation, the Reverse Stock
Split and the contemplated exchange or conversion of certain
indebtedness of a wholly owned subsidiary of Cornerstone into
shares of Cornerstone Common Stock as a condition to the closing
of the Transaction) will be consummated on the terms described
in the Agreement, without any waiver or modification of any
material terms or conditions. We also have assumed, with the
consent of Critical Therapeutics, that obtaining the necessary
regulatory or third party approvals and consents for the
Transaction or any related transaction will not have an adverse
effect on Critical Therapeutics, Cornerstone or the Transaction.
We further have assumed, with the consent of Critical
Therapeutics, that the representations and warranties of
Critical Therapeutics and Cornerstone contained in the Agreement
are true and complete and that the Transaction will qualify for
U.S. federal income tax purposes as a reorganization within
the meaning of Section 368(a) of the Internal Revenue Code
of 1986, as amended. We do not express any opinion as to any tax
or other consequences that might result from the Transaction or
any related transaction, nor does our opinion address any legal,
tax, regulatory or accounting matters, as to which we understand
that Critical Therapeutics obtained such advice as it deemed
necessary from qualified professionals. We express no view or
opinion as to any terms or other aspects or implications of the
Transaction (other than the Exchange Ratio to the extent
expressly specified herein) or any related transaction,
including, without limitation, the form or structure of the
Transaction, any adjustment to the Exchange Ratio resulting from
the Reverse Stock Split, any other aspect or implication of the
Reverse Stock Split or any agreements or arrangements entered
into in connection with, or otherwise contemplated by, the
Transaction. In addition, we express no view or opinion as to
the fairness of the amount or nature of, or any other aspects
relating to, the compensation to any officers, directors or
employees of any parties to the Transaction, or class of such
persons, relative to the Exchange Ratio or otherwise.
Lazard Frères & Co. LLC is acting as financial
advisor to Critical Therapeutics in connection with the
Transaction and will receive a fee for our services, a portion
of which is payable upon the rendering of this
D-2
The Board of Directors
Critical Therapeutics, Inc.
May 1, 2008
Page 3
opinion and a substantial portion of which is contingent upon
the closing of the Transaction. We in the past have provided and
in the future may provide investment banking services to
Critical Therapeutics, for which we have received and may
receive compensation, including having acted as exclusive
financial advisor to Critical Therapeutics in connection with a
licensing transaction in 2007. In addition, Lazard Capital
Markets LLC (LCM), an entity indirectly owned in
large part by managing directors of Lazard
Frères & Co. LLC, acted as sole placement agent
in connection with an equity offering of Critical Therapeutics
in 2006, for which LCM was paid a customary fee, a portion of
which was paid by LCM to Lazard Frères & Co. LLC
as a referral fee. In the ordinary course of their respective
businesses, affiliates of Lazard Frères & Co. LLC
and LCM may actively trade securities of Critical Therapeutics
for their own accounts and for the accounts of their customers
and, accordingly, may at any time hold a long or short position
in such securities. The issuance of this opinion was approved by
an authorized committee of Lazard Frères & Co.
LLC.
Our engagement and the opinion expressed herein are for the
benefit of the Board of Directors of Critical Therapeutics and
our opinion is rendered to the Board of Directors of Critical
Therapeutics in connection with its evaluation of the
Transaction. Our opinion does not address the merits of the
underlying decision by Critical Therapeutics to engage in the
Transaction or any related transaction or the relative merits of
the Transaction or any related transaction as compared to any
other transaction or business strategy in which Critical
Therapeutics might engage. Our opinion is not intended to and
does not constitute a recommendation to any stockholder as to
how such stockholder should vote or act with respect to the
Transaction or any matter relating thereto.
Based on and subject to the foregoing, we are of the opinion
that, as of the date hereof, the Exchange Ratio provided for
pursuant to the Agreement is fair, from a financial point of
view, to Critical Therapeutics.
Very truly yours,
LAZARD FRÈRES & CO. LLC
|
|
|
|
By:
|
/s/ Jason
R. Bernhard
|
Jason R. Bernhard
Managing Director
D-3
Annex E
GENERAL
CORPORATION LAW OF THE STATE OF DELAWARE
§
262 APPRAISAL RIGHTS.
(a) Any stockholder of a corporation of this State who
holds shares of stock on the date of the making of a demand
pursuant to subsection (d) of this section with respect to
such shares, who continuously holds such shares through the
effective date of the merger or consolidation, who has otherwise
complied with subsection (d) of this section and who has
neither voted in favor of the merger or consolidation nor
consented thereto in writing pursuant to § 228 of this
title shall be entitled to an appraisal by the Court of Chancery
of the fair value of the stockholders shares of stock
under the circumstances described in subsections (b) and
(c) of this section. As used in this section, the word
stockholder means a holder of record of stock in a
stock corporation and also a member of record of a nonstock
corporation; the words stock and share
mean and include what is ordinarily meant by those words and
also membership or membership interest of a member of a nonstock
corporation; and the words depository receipt mean a
receipt or other instrument issued by a depository representing
an interest in one or more shares, or fractions thereof, solely
of stock of a corporation, which stock is deposited with the
depository.
(b) Appraisal rights shall be available for the shares of
any class or series of stock of a constituent corporation in a
merger or consolidation to be effected pursuant to
§ 251 (other than a merger effected pursuant to
§ 251(g) of this title), § 252,
§ 254, § 257, § 258,
§ 263 or § 264 of this title:
|
|
|
|
(1)
|
Provided, however, that no appraisal rights under this section
shall be available for the shares of any class or series of
stock, which stock, or depository receipts in respect thereof,
at the record date fixed to determine the stockholders entitled
to receive notice of and to vote at the meeting of stockholders
to act upon the agreement of merger or consolidation, were
either (i) listed on a national securities exchange, or
(ii) held of record by more than 2,000 holders; and further
provided that no appraisal rights shall be available for any
shares of stock of the constituent corporation surviving a
merger if the merger did not require for its approval the vote
of the stockholders of the surviving corporation as provided in
subsection (f) of § 251 of this title.
|
|
|
(2)
|
Notwithstanding paragraph (1) of this subsection, appraisal
rights under this section shall be available for the shares of
any class or series of stock of a constituent corporation if the
holders thereof are required by the terms of an agreement of
merger or consolidation pursuant to §§ 251, 252,
254, 257, 258, 263 and 264 of this title to accept for such
stock anything except:
|
|
|
|
|
a.
|
Shares of stock of the corporation surviving or resulting from
such merger or consolidation, or depository receipts in respect
thereof;
|
|
|
b.
|
Shares of stock of any other corporation, or depository receipts
in respect thereof, which shares of stock (or depository
receipts in respect thereof) or depository receipts at the
effective date of the merger or consolidation will be either
listed on a national securities exchange or held of record by
more than 2,000 holders;
|
|
|
c.
|
Cash in lieu of fractional shares or fractional depository
receipts described in the foregoing subparagraphs a. and b. of
this paragraph; or
|
|
|
d.
|
Any combination of the shares of stock, depository receipts and
cash in lieu of fractional shares or fractional depository
receipts described in the foregoing subparagraphs a., b. and c.
of this paragraph.
|
|
|
|
|
(3)
|
In the event all of the stock of a subsidiary Delaware
corporation party to a merger effected under § 253 of
this title is not owned by the parent corporation immediately
prior to the merger, appraisal rights shall be available for the
shares of the subsidiary Delaware corporation.
|
(c) Any corporation may provide in its certificate of
incorporation that appraisal rights under this section shall be
available for the shares of any class or series of its stock as
a result of an amendment to its certificate of
E-1
incorporation, any merger or consolidation in which the
corporation is a constituent corporation or the sale of all or
substantially all of the assets of the corporation. If the
certificate of incorporation contains such a provision, the
procedures of this section, including those set forth in
subsections (d) and (e) of this section, shall apply
as nearly as is practicable.
(d) Appraisal rights shall be perfected as follows:
(1) If a proposed merger or consolidation for which
appraisal rights are provided under this section is to be
submitted for approval at a meeting of stockholders, the
corporation, not less than 20 days prior to the meeting,
shall notify each of its stockholders who was such on the record
date for such meeting with respect to shares for which appraisal
rights are available pursuant to subsection (b) or
(c) hereof that appraisal rights are available for any or
all of the shares of the constituent corporations, and shall
include in such notice a copy of this section. Each stockholder
electing to demand the appraisal of such stockholders
shares shall deliver to the corporation, before the taking of
the vote on the merger or consolidation, a written demand for
appraisal of such stockholders shares. Such demand will be
sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends
thereby to demand the appraisal of such stockholders
shares. A proxy or vote against the merger or consolidation
shall not constitute such a demand. A stockholder electing to
take such action must do so by a separate written demand as
herein provided. Within 10 days after the effective date of
such merger or consolidation, the surviving or resulting
corporation shall notify each stockholder of each constituent
corporation who has complied with this subsection and has not
voted in favor of or consented to the merger or consolidation of
the date that the merger or consolidation has become effective;
or
(2) If the merger or consolidation was approved pursuant to
§ 228 or § 253 of this title, then either a
constituent corporation before the effective date of the merger
or consolidation or the surviving or resulting corporation
within 10 days thereafter shall notify each of the holders
of any class or series of stock of such constituent corporation
who are entitled to appraisal rights of the approval of the
merger or consolidation and that appraisal rights are available
for any or all shares of such class or series of stock of such
constituent corporation, and shall include in such notice a copy
of this section. Such notice may, and, if given on or after the
effective date of the merger or consolidation, shall, also
notify such stockholders of the effective date of the merger or
consolidation. Any stockholder entitled to appraisal rights may,
within 20 days after the date of mailing of such notice,
demand in writing from the surviving or resulting corporation
the appraisal of such holders shares. Such demand will be
sufficient if it reasonably informs the corporation of the
identity of the stockholder and that the stockholder intends
thereby to demand the appraisal of such holders shares. If
such notice did not notify stockholders of the effective date of
the merger or consolidation, either (i) each such
constituent corporation shall send a second notice before the
effective date of the merger or consolidation notifying each of
the holders of any class or series of stock of such constituent
corporation that are entitled to appraisal rights of the
effective date of the merger or consolidation or (ii) the
surviving or resulting corporation shall send such a second
notice to all such holders on or within 10 days after such
effective date; provided, however, that if such second notice is
sent more than 20 days following the sending of the first
notice, such second notice need only be sent to each stockholder
who is entitled to appraisal rights and who has demanded
appraisal of such holders shares in accordance with this
subsection. An affidavit of the secretary or assistant secretary
or of the transfer agent of the corporation that is required to
give either notice that such notice has been given shall, in the
absence of fraud, be prima facie evidence of the facts stated
therein. For purposes of determining the stockholders entitled
to receive either notice, each constituent corporation may fix,
in advance, a record date that shall be not more than
10 days prior to the date the notice is given, provided,
that if the notice is given on or after the effective date of
the merger or consolidation, the record date shall be such
effective date. If no record date is fixed and the notice is
given prior to the effective date, the record date shall be the
close of business on the day next preceding the day on which the
notice is given.
(e) Within 120 days after the effective date of the
merger or consolidation, the surviving or resulting corporation
or any stockholder who has complied with subsections (a)
and (d) of this section hereof and who
E-2
is otherwise entitled to appraisal rights, may commence an
appraisal proceeding by filing a petition in the Court of
Chancery demanding a determination of the value of the stock of
all such stockholders. Notwithstanding the foregoing, at any
time within 60 days after the effective date of the merger
or consolidation, any stockholder who has not commenced an
appraisal proceeding or joined that proceeding as a named party
shall have the right to withdraw such stockholders demand
for appraisal and to accept the terms offered upon the merger or
consolidation. Within 120 days after the effective date of
the merger or consolidation, any stockholder who has complied
with the requirements of subsections (a) and (d) of
this section hereof, upon written request, shall be entitled to
receive from the corporation surviving the merger or resulting
from the consolidation a statement setting forth the aggregate
number of shares not voted in favor of the merger or
consolidation and with respect to which demands for appraisal
have been received and the aggregate number of holders of such
shares. Such written statement shall be mailed to the
stockholder within 10 days after such stockholders
written request for such a statement is received by the
surviving or resulting corporation or within 10 days after
expiration of the period for delivery of demands for appraisal
under subsection (d) hereof, whichever is later.
Notwithstanding subsection (a) of this section, a person
who is the beneficial owner of shares of such stock held either
in a voting trust or by a nominee on behalf of such person may,
in such persons own name, file a petition or request from
the corporation the statement described in this subsection.
(f) Upon the filing of any such petition by a stockholder,
service of a copy thereof shall be made upon the surviving or
resulting corporation, which shall within 20 days after
such service file in the office of the Register in Chancery in
which the petition was filed a duly verified list containing the
names and addresses of all stockholders who have demanded
payment for their shares and with whom agreements as to the
value of their shares have not been reached by the surviving or
resulting corporation. If the petition shall be filed by the
surviving or resulting corporation, the petition shall be
accompanied by such a duly verified list. The Register in
Chancery, if so ordered by the Court, shall give notice of the
time and place fixed for the hearing of such petition by
registered or certified mail to the surviving or resulting
corporation and to the stockholders shown on the list at the
addresses therein stated. Such notice shall also be given by 1
or more publications at least 1 week before the day of the
hearing, in a newspaper of general circulation published in the
City of Wilmington, Delaware or such publication as the Court
deems advisable. The forms of the notices by mail and by
publication shall be approved by the Court, and the costs
thereof shall be borne by the surviving or resulting corporation.
(g) At the hearing on such petition, the Court shall
determine the stockholders who have complied with this section
and who have become entitled to appraisal rights. The Court may
require the stockholders who have demanded an appraisal for
their shares and who hold stock represented by certificates to
submit their certificates of stock to the Register in Chancery
for notation thereon of the pendency of the appraisal
proceedings; and if any stockholder fails to comply with such
direction, the Court may dismiss the proceedings as to such
stockholder.
(h) After the Court determines the stockholders entitled to
an appraisal, the appraisal proceeding shall be conducted in
accordance with the rules of the Court of Chancery, including
any rules specifically governing appraisal proceedings. Through
such proceeding the Court shall determine the fair value of the
shares exclusive of any element of value arising from the
accomplishment or expectation of the merger or consolidation,
together with interest, if any, to be paid upon the amount
determined to be the fair value. In determining such fair value,
the Court shall take into account all relevant factors. Unless
the Court in its discretion determines otherwise for good cause
shown, interest from the effective date of the merger through
the date of payment of the judgment shall be compounded
quarterly and shall accrue at 5% over the Federal Reserve
discount rate (including any surcharge) as established from time
to time during the period between the effective date of the
merger and the date of payment of the judgment. Upon application
by the surviving or resulting corporation or by any stockholder
entitled to participate in the appraisal proceeding, the Court
may, in its discretion, proceed to trial upon the appraisal
prior to the final determination of the stockholders entitled to
an appraisal. Any stockholder whose name appears on the list
filed by the surviving or resulting corporation pursuant to
subsection (f) of this section and who has submitted such
stockholders certificates of
E-3
stock to the Register in Chancery, if such is required, may
participate fully in all proceedings until it is finally
determined that such stockholder is not entitled to appraisal
rights under this section.
(i) The Court shall direct the payment of the fair value of
the shares, together with interest, if any, by the surviving or
resulting corporation to the stockholders entitled thereto.
Payment shall be so made to each such stockholder, in the case
of holders of uncertificated stock forthwith, and the case of
holders of shares represented by certificates upon the surrender
to the corporation of the certificates representing such stock.
The Courts decree may be enforced as other decrees in the
Court of Chancery may be enforced, whether such surviving or
resulting corporation be a corporation of this State or of any
state.
(j) The costs of the proceeding may be determined by the
Court and taxed upon the parties as the Court deems equitable in
the circumstances. Upon application of a stockholder, the Court
may order all or a portion of the expenses incurred by any
stockholder in connection with the appraisal proceeding,
including, without limitation, reasonable attorneys fees
and the fees and expenses of experts, to be charged pro rata
against the value of all the shares entitled to an appraisal.
(k) From and after the effective date of the merger or
consolidation, no stockholder who has demanded appraisal rights
as provided in subsection (d) of this section shall be
entitled to vote such stock for any purpose or to receive
payment of dividends or other distributions on the stock (except
dividends or other distributions payable to stockholders of
record at a date which is prior to the effective date of the
merger or consolidation); provided, however, that if no petition
for an appraisal shall be filed within the time provided in
subsection (e) of this section, or if such stockholder
shall deliver to the surviving or resulting corporation a
written withdrawal of such stockholders demand for an
appraisal and an acceptance of the merger or consolidation,
either within 60 days after the effective date of the
merger or consolidation as provided in subsection (e) of
this section or thereafter with the written approval of the
corporation, then the right of such stockholder to an appraisal
shall cease. Notwithstanding the foregoing, no appraisal
proceeding in the Court of Chancery shall be dismissed as to any
stockholder without the approval of the Court, and such approval
may be conditioned upon such terms as the Court deems just;
provided, however that this provision shall not affect the right
of any stockholder who has not commenced an appraisal proceeding
or joined that proceeding as a named party to withdraw such
stockholders demand for appraisal and to accept the terms
offered upon the merger or consolidation within 60 days
after the effective date of the merger or consolidation, as set
forth in subsection (e) of this section.
(l) The shares of the surviving or resulting corporation
to which the shares of such objecting stockholders would have
been converted had they assented to the merger or consolidation
shall have the status of authorized and unissued shares of the
surviving or resulting corporation.
E-4