UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
(Rule 14a101)
INFORMATION REQUIRED IN CONSENT STATEMENT
SCHEDULE 14A INFORMATION
Consent Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934
Filed by the Registrant ¨ Filed by a Party other than the Registrant x
Check the appropriate box:
¨ | Preliminary Consent Statement | |
¨ | Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) | |
¨ | Definitive Consent Statement | |
x | Definitive Additional Materials | |
¨ | Soliciting Material Under Rule 14a-12 |
PUMA BIOTECHNOLOGY, INC.
(Name of Registrant as Specified in Its Charter)
FREDRIC N. ESHELMAN, PHARM.D.
JAMES M. DALY
SETH A. RUDNICK, M.D.
KENNETH B. LEE, JR.
(Name of Persons(s) Filing Consent Statement, if Other Than the Registrant)
Payment of Filing Fee (Check the appropriate box):
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(4) | Date Filed:
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Dr. Fredric N. Eshelman, James M. Daly, Seth A. Rudnick, and Kenneth B. Lee, Jr. (collectively, the Participants), filed a definitive consent statement and accompanying form of consent card with the Securities and Exchange Commission to be used in the solicitation of written consents from the stockholders of Puma Biotechnology, Inc. (the Company) to increase the size of the Companys board of directors from five to nine members and elect four new directors.
On November 30, 2015, the Participants made a presentation to Institutional Shareholder Services Inc. A copy of the slides used in that presentation is provided below.
PUMA BIOTECHNOLOGY, INC. CONSENT SOLICITATION Information for Investors November 2015 |
Certain Disclosures DR. FREDRIC N. ESHELMAN (DR. ESHELMAN) DOES NOT ASSUME RESPONSIBILITY FOR INVESTMENT DECISIONS. THIS PRESENTATION
DOES NOT RECOMMEND THE PURCHASE
OR SALE OF ANY SECURITY. UNDER NO CIRCUMSTANCES IS THIS PRESENTATION TO BE USED OR CONSIDERED AS AN OFFER TO SELL OR A SOLICITATION OF AN OFFER TO BUY ANY SECURITY. IT IS POSSIBLE THAT THERE WILL BE DEVELOPMENTS IN THE FUTURE THAT CAUSE ONE OR MORE OF THE
PARTICIPANTS FROM TIME TO TIME TO SELL ALL OR A PORTION
OF THEIR SHARES IN OPEN MARKET TRANSACTIONS OR OTHERWISE INCLUDING VIA SHORT SALES), BUY ADDITIONAL SHARES (IN OPEN MARKET OR PRIVATELY NEGOTIATED TRANSACTIONS OR OTHERWISE) OR TRADE IN OPTIONS, PUTS, CALLS OR OTHER DERIVATIVE INSTRUMENTS RELATING TO
SUCH SHARES. DR.
ESHELMAN
RESERVES
THE
RIGHT
TO CHANGE ANY OF HIS OPINIONS EXPRESSED HEREIN AT ANY TIME AS HE DEEMS APPROPRIATE. DR. ESHELMAN DISCLAIMS ANY OBLIGATION TO UPDATE THE INFORMATION CONTAINED HEREIN. CERTAIN DATA AND INFORMATION USED IN THE ACCOMPANYING ANALYSES CONTAINED
HEREIN HAS BEEN OBTAINED FROM SOURCES THAT DR. ESHELMAN
BELIEVES TO BE RELIABLE, IS SUBJECT TO CHANGE WITHOUT NOTICE, IS NOT GUARANTEED TO BE ACCURATE, AND MAY NOT CONTAIN ALL MATERIAL INFORMATION CONCERNING THE SECURITIES WHICH MAY BE THE SUBJECT OF THE ANALYSES. DR. ESHELMAN HAS NOT SOUGHT OR OBTAINED CONSENT FROM ANY THIRD PARTY TO USE ANY STATEMENTS OR INFORMATION INDICATED IN THIS PRESENTATION AS HAVING BEEN
OBTAINED OR DERIVED FROM
STATEMENTS
MADE
OR PUBLISHED BY THIRD PARTIES. ANY SUCH STATEMENTS OR INFORMATION SHOULD NOT BE VIEWED AS INDICATING THE SUPPORT OF SUCH THIRD PARTY FOR THE VIEWS EXPRESSED HEREIN. DR. ESHELMAN MAY HAVE RELIED UPON CERTAIN QUANTITATIVE AND QUALITATIVE ASSUMPTIONS WHEN PREPARING THE ANALYSES HEREIN WHICH MAY
NOT BE ARTICULATED AS PART OF SUCH ANALYSES. THE
REALIZATION OF THE ASSUMPTIONS ON WHICH SUCH ANALYSES WERE BASED IS SUBJECT TO SIGNIFICANT UNCERTAINTIES, VARIABILITIES AND CONTINGENCIES AND MAY CHANGE MATERIALLY IN RESPONSE TO SMALL CHANGES IN THE ELEMENTS THAT COMPRISE THE
ASSUMPTIONS, INCLUDING THE
INTERACTION
OF SUCH ELEMENTS. FURTHERMORE, THE ASSUMPTIONS ON WHICH THE ANALYSES WERE BASED MAY BE NECESSARILY ARBITRARY, MAY BE MADE AS OF THE DATE OF THE ANALYSES, DO NOT NECESSARILY REFLECT HISTORICAL EXPERIENCE WITH RESPECT TO SECURITIES SIMILAR TO THOSE THAT MAY
BE CONTAINED IN THE ANALYSES, AND DO NOT CONSTITUTE A
PRECISE PREDICTION AS TO FUTURE EVENTS.
BECAUSE
OF THE UNCERTAINTIES AND SUBJECTIVE JUDGMENTS INHERENT IN SELECTING THE ASSUMPTIONS ON WHICH THE ANALYSES WERE BASED AND BECAUSE FUTURE EVENTS AND CIRCUMSTANCES CANNOT BE PREDICTED, THE ACTUAL RESULTS REALIZED MAY DIFFER MATERIALLY FROM THOSE PROJECTED IN THE
ANALYSES. NOTHING INCLUDED IN THESE ANALYSES CONSTITUTES
ANY REPRESENTATION OR WARRANTY BY DR. ESHELMAN AS TO FUTURE PERFORMANCE. NO REPRESENTATION OR WARRANTY IS MADE BY DR. ESHELMAN AS TO THE REASONABLENESS, ACCURACY OR SUFFICIENCY OF THE ASSUMPTIONS ON WHICH THE ANALYSES WERE BASED OR AS TO ANY OTHER FINANCIAL INFORMATION THAT IS CONTAINED IN THE ANALYSES, INCLUDING THE ASSUMPTIONS ON WHICH THEY WERE BASED.
DR. ESHELMAN SHALL NOT BE LIABLE FOR EITHER (I) ANY
ERRORS OR OMISSIONS MADE IN DISSEMINATING THE DATA OR ANALYSES CONTAINED HEREIN OR (II) DAMAGES (INCIDENTAL, CONSEQUENTIAL OR OTHERWISE) WHICH MAY ARISE FROM YOUR OR ANY OTHER PARTYS USE OF THE DATA OR ANALYSES CONTAINED HEREIN. THE INFORMATION THAT IS CONTAINED HEREIN SHOULD NOT BE CONSTRUED AS FINANCIAL, LEGAL, INVESTMENT, TAX, OR OTHER ADVICE. YOU
ULTIMATELY MUST RELY UPON YOUR OWN EXAMINATION AND THAT
OF YOUR PROFESSIONAL ADVISORS, INCLUDING LEGAL COUNSEL AND ACCOUNTANTS AS TO THE LEGAL, ECONOMIC, TAX, REGULATORY, OR ACCOUNTING TREATMENT, SUITABILITY, AND OTHER ASPECTS OF THE ANALYSES HEREIN.
ON NOVEMBER 18, 2015, DR. ESHELMAN, JAMES M. DALY, SETH A. RUDNICK AND KENNETH B. LEE, JR. (TOGETHER WITH DR. ESHELMAN, THE "PARTICIPANTS") FILED A DEFINITIVE CONSENT STATEMENT AND ACCOMPANYING FORM OF CONSENT CARD WITH THE SECURITIES AND EXCHANGE COMMISSION (THE SEC) ON SCHEDULE 14A TO BE USED IN CONNECTION WITH THE SOLICITATION OF CONSENTS (THE CONSENT SOLICITATION) FROM THE STOCKHOLDERS OF PUMA
BIOTECHNOLOGY, INC. (THE
"COMPANY")
TO INCREASE THE SIZE OF THE COMPANYS BOARD OF DIRECTORS FROM FIVE TO NINE MEMBERS AND ELECT FOUR NEW DIRECTORS. ALL STOCKHOLDERS OF THE COMPANY ARE ADVISED TO READ THE DEFINITIVE CONSENT STATEMENT AND OTHER DOCUMENTS RELATED TO THE CONSENT
SOLICITATION BY THE
PARTICIPANTS
BECAUSE
THEY
CONTAIN
IMPORTANT
INFORMATION,
INCLUDING
ADDITIONAL
INFORMATION
RELATED
TO THE PARTICIPANTS AND A DESCRIPTION OF THEIR DIRECT OR INDIRECT INTERESTS BY SECURITY HOLDINGS. THE DEFINITIVE CONSENT STATEMENT AND ACCOMPANYING CONSENT CARD HAVE BEEN FURNISHED TO SOME OR ALL OF THE COMPANY'S STOCKHOLDERS AND ARE, ALONG WITH OTHER RELEVANT DOCUMENTS, AVAILABLE AT NO CHARGE ON THE
INTERNET AT
WWW.OKAPIVOTE.COM/PUMABIOTECHNOLOGY
OR ON THE SEC'S WEBSITE AT HTTP://WWW.SEC.GOV/. IN ADDITION, OKAPI PARTNERS LLC, DR. ESHELMAN'S CONSENT SOLICITOR, WILL PROVIDE COPIES OF THE DEFINITIVE CONSENT STATEMENT AND ACCOMPANYING CONSENT CARD WITHOUT CHARGE UPON REQUEST BY
CALLING (877) 869-0171 OR BY EMAILING
INFO@OKAPIPARTNERS.COM. 2
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Fredric N. Eshelman, Pharm.D. Founder of Eshelman Ventures, LLC, an investment company primarily focused on healthcare companies. Non-Executive Chairman of The Medicines Company, a global
biopharmaceutical company focused on saving lives, alleviating
suffering and contributing to the economics of
healthcare by focusing on the leading acute and
intensive care hospitals worldwide. Founder and former
CEO and Executive Chairman of Pharmaceutical Product
Development, Inc. (PPDI), a global contract pharmaceutical research organization. Founding Chairman of Furiex Pharmaceuticals, Inc. (Furiex), a company that licensed and rapidly developed new medicines. Former director and Senior Vice President, Development of Glaxo, Inc.,
predecessor to GlaxoSmithKline plc.
Education: Pharm.D., University of Cincinnati; B.S., UNC-Chapel
Hill. PPDI: Total Shareholder Return
Furiex: Total Shareholder Return
421% 495% 3 |
Background Of Investment 4 Between May 18, 2015 and June 4, 2015, I purchased a total of 150,000 shares of Pumas common stock. Between October 22, 2015 and November 3, 2015, I acquired options to purchase 150,000 shares of Pumas common stock. As a result of these transactions, I am the beneficial owner of 300,000 shares, representing approximately 1% of Pumas common stock. Meanwhile, over the last 2 years, current directors and officers have collectively engaged in net aggregate sales of stock valued at a total of approximately $18,761,916.57. 1 1. Source: Transactions listed in Participant Transaction Chart on page 43 of the
Preliminary Consent Revocation Statement. Calculations based on
closing price for the date of sale listed.
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Company Overview Puma Biotechnology, Inc. (NYSE: PBYI) (Puma or the Company), a Delaware corporation and
development stage biopharmaceutical company, focuses on the
acquisition, development and commercialization of
products for the treatment of various forms of cancer.
5 Name % Outstanding Adage Capital Management LP 17.5% Fidelity Management & Research Co. 14.9% Alan H. Auerbach 12.5%* The Vanguard Group, Inc. 5.5% Capital Research & Management Co. (Global Investors) 5.4% T. Rowe Price Associates, Inc. 5.3% Grantham, Mayo, Van Otterloo & Co. LLC 5.2% Orbimed Advisors LLC 3.7% Franklin Advisers, Inc. 3.0% Frank Zavrl 2.8% Alan H. Auerbach CEO and President Richard Bryce SVP, Clinical Research and Development Charles R. Eyler SVP, Finance and Administration and Treasurer Alan H. Auerbach Chairman Jay M. Moyes Adrian M. Senderowicz Troy E. Wilson Frank E. Zavrl Headquarters: Los Angeles, CA Full-time Employees (12/31/14): 120 Market Cap (11/27/15): $2.426 billion Closing price (11/27/15): $74.78 per share * Excludes 2,116,250 shares exercisable pursuant to anti-dilutive
warrant and options to purchase 399,999 shares exercisable within
60 days of April 17, 2015.
Sources: Capital IQ; SEC Filings; Bloomberg; NASDAQ. Amounts as of
September 30, 2015 unless otherwise indicated.
Calculation of percentage outstanding assumes 32,435,748
shares outstanding as of November 2, 2015, as reported
in Form 10-Q filed on November 9,
2015. |
Single Drug Candidate Neratinib/PB272 (oral): treatment of breast cancer patients, non- small cell lung cancer patients, and patients with HER2 mutation- positive solid tumors. Puma is scheduled to present three-year data from the ExteNET trial of neratinib on December 11, 2015 at the San Antonio Breast Cancer Symposium (SABCS). This data will form the basis of the Companys new drug application (NDA) to be filed with the FDA in Q1 2016. NDA filings are an onerous and complicated process that require significant expertise and experience. Previous data releases from the ExteNET trial have been the main driver of Pumas stock value. According to Company CEO Alan H. Auerbach, they expect widening of curve separation (more survival effect) with three- year data. Company Overview 6 Source: SEC filings Source: Puma website. |
Why Am I Soliciting Consents? 7 Board and management practices are reducing stockholder value. o Stock price underperformance relative to the biotechnology industry and the Companys
closest peers over the most recent six-month and one-year
periods. Stockholders have been whipsawed in both
directions by management; we have seen significant stock volatility over the last six to nine months. o History of mismanaging market expectations, including making problematic statements and
not meeting announced targets or milestones relating to clinical
trials. o
Stockholder unfriendly executive compensation practices.
o Board and management unresponsive and not transparent - my requests for Company documents, including board minutes, through 220 demands under Delaware Corporate
Law, were denied after repeated requests. Recently I had to
file suit in Delaware to obtain requested stockholder
information that is readily available to companies and that I am entitled to as a shareholder. Nominees would add unique expertise and bring a more stockholder-friendly
perspective.
o Highly qualified and experienced slate of nominees will add value to the board without replacing current directors. o Improved oversight of management in executing Pumas value proposition and in
navigating assets through the regulatory process.
o Initiatives to improve transparency for Pumas investors. |
Consent Solicitation Overview 8 |
Consent Solicitation Goals Increase the size of Pumas board from five to nine directors. Elect four highly qualified and experienced directors. No incumbent directors will be replaced. The Nominees will each add unique expertise and experience to ensure a successful strategy for navigating the development and regulatory process, and ultimately, a strategy for bringing valuable drugs to market. 9 |
Consent Solicitation Proposals Proposal 1: Repeal Amendments to the Bylaws o Adoption of Proposal 1 will ensure that the current board cannot (i) prevent or
impair the stockholders ability to add the Nominees to the
Board or (ii) limit the Nominees ability to take
actions in the best interests of the Company and its
stockholders, if elected.
Proposal 2: Removal of Directors o Adoption of Proposal 2 will remove any additional directors appointed after
September 9, 2015 and prior to the effectiveness of Proposal 2, but
will not remove any current directors.
Proposal 3: Increase the Size of the Board o Adoption of Proposal 3 will increase the size of Pumas board from five to nine
directors.
Proposal 4: Election of the Nominees o Adoption of Proposal 4 will elect the Nominees to serve as directors of the
Company.
o Stockholders may consent to the election of all or some of the Nominees.
10 |
Dramatic Stock Price Underperformance Puma shares have significantly underperformed the S&P 500 and NYSE
Arca Biotechnology Index. 11 Source: Capital IQ Dr. Eshelman Initial Investment Preliminary Consent Solicitation Filed While the Company has performed generally in line with peers since its IPO in 2012
and outperformed last year due to early trial results and heightened
expectations, since the disappointing data was released
the Company has underperformed and we believe that value
will continue to be destroyed if there is no change in the status quo. |
Dramatic Stock Price Underperformance Puma has also significantly underperformed its closest peer companies.
12 Source: Capital IQ |
13 History of Problematic Statements: Background ExteNET Trial Description Started by Pfizer Inc. in April 2009. Enrolled 2,821 patients in 41 countries. Double-blind, placebo-controlled, Phase III trial of neratinib vs. placebo
after adjuvant treatment with trastuzumab (Herceptin) in
women with early stage HER2+ breast cancer.
After one year of adjuvant treatment with Herceptin, patients were
randomized 1:1 to receive extended adjuvant therapy with neratinib or
placebo for one year.
Patients were then followed for recurrent disease, ductal carcinoma in
situ or death for a period of two years after randomization into
ExteNET, or three years since the initial start of
Herceptin. Primary Trial in Support of
Q116 NDA |
14 ExteNET Results Presented to Date Two-year disease free survival (DFS) 93.9% neratinib, 91.6%
placebo.
In approximately 60.0% of patients for whom there was a centrally-confirmed HER2 result available, the numbers were
94.7% and 90.6% respectively.
In centrally-confirmed HER2+ patients with hormone receptor
positive disease (HR+) the results were approximately 97.0%
and 88.4% respectively.
Grade 3 or higher diarrhea 39.9% of neratinib treated patients (no loparemide prophylaxis). History of Problematic Statements: Background Absolute DFS difference: 2.3% at 2 years. |
We continue to expect the Extenet data in Chicago to show the 3+% difference between the two arms
We see a low probability of any negative data surprises
- RBC Capital Markets, May 11 2015 History of Problematic Statements: Optimistic Statements by Puma 15 The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. Puma Press Release, July 22, 2014 We saw a 33% improvement in invasive disease-free survival. - Puma Conference call, May 7, 2015 Most importantly, a number of those subgroups are extremely differentiating from the other HER2 agents that are commercially available. So, I think there is certainly the opportunity for the drug to be used in all patients directly after treatment in year one with Herceptin. Puma Conference Call, July 22, 2014 Beginning on July 22, 2014, and continuing until as late as May 7, 2015, Puma claimed that the ExteNET
data would show that neratinib significantly improves results in breast
cancer patients over a placebo. We spoke to Puma about
the upcoming abstracts
In addition
to what is already known, the
abstract from the ph3 ExteNET trial
will include the actual 2yr DFS
values, and key subset analyses
that will show neratinib forms well in
populations typically challenging
for Perjeta and Kadcyla.
-
UBS, May 4, 2015
We see upside potential at ASCO, where
we think ExteNET data will show well.
-
UBS, May 5 2015
Given prior comments from PBYI,
investors had expectation of at least a
3% absolute benefit, and perhaps a
benefit as high as 4-5%.
-
Cowen and Company, May 13, 2015
Analysts high expectations followed:
|
Most investors and oncologists had approximated the minimum delta between the two arms
to be about 3% in order to achieve meaningful clinical significance.
On its face, the 2.3% IDFS difference falls below
expectations
it is not surprising why the stock is down 25%... RBC Capital Markets, May 14, 2015 History of Problematic Statements: Clinical Trial Data Inconsistent With Expectations 16 [T]he absolute magnitude of difference in DFS was trivial. Neratanibs use
is likely to be limited to a small subset
-Cowen and Company, May 21, 2015
Between May 13, 2015 and June 1, 2015, Puma released additional ExteNET
data, which was presented at the American Society of
Clinical Onocology (ASCO) annual meeting. The
newly released ExteNET data did not meet analysts high expectations. [T]he point estimate at the 2yr landmark is below the 3pp delta set by investors
One
can debate the expectation management
We recognize anger about
expectations coming in.
UBS, May 13, 2015 |
17 While the Company continued to tout the success of the ExteNET Trial at the June
2015 ASCO meeting, significant portions of the analyst, investor, and
medical communities saw the data and clearly
disagreed. Pumas stock price plummeted.
[W]e view the sell off as
more of a reaction to falling
short of misguided
expectations rather than a
fatal flaw in neratinibs clinical
profile.
The absolute
treatment benefit over
placebo (2.3%) was materially
below where management
had implied when topline
data were first released in July
2014.
-J.P. Morgan, August 27, 2015
ASCO
Presentation
History of Problematic Statements:
Clinical Trial Data Inconsistent With Expectations
We believe that the market reacted primarily to results that did not
meet management-driven expectations for the data
that were not realized when detailed data was released;
however, there is still potential for significant value
in developing neratinib. |
History of Problematic Statements: Regulatory Plan and Cancer Indication 18 Source: Capital IQ Yes, we are still planning to file the NDA for the ExteNET Study in the first half of 2015. - Alan Auerbach, Conference Call, November 13, 2014 Since the Companys initial NDA filing will now be for the extended
adjuvant HER2-positive early stage breast cancer indication
Puma intends to delay its proposed timeline for filing
the NDA until the first quarter of 2016.
-
Puma Press Release,
December 2, 2014
Management has a history of mismanaging market
expectations.
For example, Puma stated on several occasions, including as late as November 13, 2014, that it would file a new drug application (NDA) for neratinib during the first quarter of 2015.
Less than three weeks later, on December 2, 2014, Puma pushed the projected date of its
NDA filing to the first quarter of 2016.
12%
Decline
Puma may claim that the delay was due to the FDAs requirement that the Company file carcinogenicity data, and that it had no control. But we believe that the company should have known that this data would be required because filing for a long-term indication always requires this data. We believe that Puma mismanaged the regulatory process. |
History of Problematic Statements: Other Trials 19 The Company held a conference call on December 23, 2013 to discuss HER2
mutation trials.
We have tried to locate the transcript but have been unable to do so.
As far as we can tell, the transcript seems to be missing and
unavailable.
However, according to reports written by at least two analysts about
the call:
With respect to the refractory NSCLC trial, Mr. Auerbach stated that
response rates in both arms of the trial were in the
40-49% range.
Data released on September 9, 2014 was not consistent with the
earlier statement (N=27).
NERAT NERAT + TORISEL Partial Response 0 3 (21%) Stable Disease 7 (54%) 11 (79%) Clinical benefit 4 (31%) 9 (64%) |
History of Problematic Statements: Public Disclosures & Drug Development Process 20 Clinical Trials Diarrhea problem evident in early PFE datawhy no protocol amendments for loparemide
prophylaxis?
Equivocating on the extent of data to be presented in December 2015 on ExteNET and other trials.
Public Filings
In its S-1/A filed on October 17, 2012, the Company outlined its business strategy:
S-1/A Strategy
Current
Status
An Investigational
New Drug Application
(IND)
would
be filed for the IV form of neratinib in 2013.
The Company has not filed an IND for the IV form of
neratinib.
The Company would in-license additional compounds.
The Company has not licensed any additional
compounds.
ExteNET
trial would be wound down.
Important data
from the ExteNET
trial
has not yet been
released.
Compound PB357
would be evaluated for further
development in 2013.
2013 10-K: We are evaluating PB357 and considering options relative to its development in 2013.
2014 10-K: We are evaluating PB357 and considering options relative to its development in 2014.
2015 10-K: We are evaluating PB357 and considering options relative to its development in 2015. |
M&A Speculation 21 There has been speculation regarding M&A for quite some time. Analysts have also commented: Cowen 5/5/15: ..[F]uture stock performance appears increasingly dependent on M&A, an outcome we
have little visibility on.
Puma management has acknowledged that a sale of the company may
be the optimal way
to maximize shareholder value and allow neratinib to realize its full potential
In our view, Puma is likely to generate significant acquisition interest...
[O]ur
optimism
for
an M&A exit is somewhat tempered by the fact that [Puma] has been investigating a potential sale for several months... UBS 5/4/15: We reiterate our Buy rating and see Puma as a prime acquisition candidate.
Interestingly,
right
around
the
early
May
timeframe,
the
SVP
of BD left the Company. UBS 5/20/15: Will Puma be acquired We have felt that there isnt a rush to acquire until the calendar flips to 2016 so that its
dilutive only for one year and carc/filing is
de-risked. That said, one reason to move sooner
rather
than
later
is to execute on the long-duration trials to max out the tail potential. CVRs may be acceptable to reflect upside sales optionality. |
Stockholder Discontent 22 Auerbach and Eyler received nearly $22.3 million in salary and
incentive-based annual compensation in 2014 alone, all materially
enhanced as a result of deceiving the investing
public... -Stockholder Consolidated Complaint,
October 16, 2015
A stockholder class action complaint was filed on June 3, 2015 in the
U.S. District Court for the Central District of
California against Puma, Alan Auerbach and Charles
Eyler.
In the complaint, the stockholder plaintiffs alleged violations of
federal securities laws, including claims under
Sections 10(b) and 20(a) of the Exchange Act, stemming
from Defendants allegedly problematic statements and failure to disclose material adverse facts regarding the results of the ExteNET trial and the
efficacy of neratinib.
The plaintiffs allege that the defendants, including Auerbach and Eyler, engaged
in a scheme to deceive investors and the market and a course of
conduct that artificially inflated the price of Puma
stock and operated as a fraud or deceit on Class Period
purchasers of Puma stock by misrepresenting and omitting material information about neratinib
The outcome of the stockholder litigation is currently pending.
The Companys problematic statements have already led some
stockholders to take legal action.
|
History of Problematic Statements: Impact On Pumas Stock Price July 22, 2014 closing price: $59.03. Following market close the Company issued a press
release and held a conference call announcing
two-year results from the ExteNET
trial.
July 23, 2014 closing price: $233.43. Stock reached its historical high of $270.83 per share on September 12, 2014.
23 Puma Biotechnology Inc. soared after the company yesterday reported positive trial
results for its breast cancer drug
Puma shares almost quadrupled
-Bloomberg, July 23, 2014 Source: Capital IQ Jul. 22 Release of Positive ExteNET Results Jul. 23 closing price- $233.43 Sept. 12 All-time High June 1 ASCO Presentation |
History of Problematic Statements: Soaring Stock Price & Effect On Executive Compensation Chairman, President and CEO Alan Auerbach and SVP Finance and Administration and
Treasurer Charles Eyler were each rewarded with generous cash and
stock bonuses for 2014.
24 In its Proxy statement, filed in April 2015, the Company justified its 2014 executive
compensation program on the following factors:
Price of the common stock increased approximately 1,302% between the
Companys initial OTC listing in April 2012 and the end of its
2014 fiscal year.
Price of the common stock increased approximately 83% during the
Companys 2014 fiscal year.
Positive ExteNET results announced by the Company in July 2014.
Eyler:
$117,610 cash bonus 31,500 shares Total Value: $4,499,559 Auerbach: $300,000 cash bonus Options to purchase150,000 shares Total Value: $17,797,606 Sources: SEC Filings. |
Stockholder Unfriendly Executive Compensation The Companys overall executive compensation program is excessive, is
not aligned with shareholder interests, and does not reflect best
practices.
Pumas executive and director compensation levels are
excessive.
Alan Auerbachs total annual compensation for 2014 was almost 8x
the ISS peer group median and included an outsized
equity award equal to more than 26x his base
salary.
Pumas outside directors each received compensation in excess of
$1.175 million for 2014.
Failure to implement formula-based incentive plans with objective
metrics and goals.
Puma has a discretionary executive cash bonus program and does not use
any performance-vesting equity awards for its
executives.
Both ISS and Glass Lewis have identified Pumas executive
compensation program as not being linked to performance
and concerns with the structure of long-term
incentive pay. 25 |
Stockholder Unfriendly Executive Compensation Executive compensation practices that are not consistent with best practices and
investor expectations.
Puma only provides its stockholders with an opportunity to vote on its executive
compensation program once every three years (triennial
say-on-pay). In 2014, only 15.4% of
Russell 3000 companies provided triennial votes.
1 Puma discloses no clawback, anti-hedging or anti-pledging policies.
CEO Auerbach has 280G gross-up protection. Pumas equity incentive plan is dilutive and expensive. More than 1/3 of Pumas stockholders voted against the 2015 and 2014 equity plan
proposals to approve additional shares to increase plan capacity.
According to Glass Lewis, the total potential dilution from the plan is 31.97%, while peer
average total dilution is 20.41% and the peer median is 18.67%, and
the three-year burn rate is more than 2x the peer
median rate (5.64% v. 2.80%). ISS calculated the one-year 2014 burn rate at 6.62%. Glass Lewis calculated the projected annual cost of the plan per employee at more than
22x the peer average, with an annual per employee cost of over $2.5
million. 1. Source: Towers Watson.
26 Pumas compensation practices reflect a board that is not responsive to
shareholder concerns. |
Failure to Respond to 220 Demand Pumas current board and management are not sufficiently committed to
transparent disclosure or responsive to legitimate stockholder
concerns.
In July 2015, I exercised my right as a stockholder under DGCL
Section 220 to request copies of the Companys
board minutes. o
My request was narrowly tailored for the purpose of enabling me to
analyze and value my ownership stake.
o The Company engaged in a pattern of delays and requested additional time to
respond.
o Eventually, the Company claimed that it is under no obligation to comply based on its
belief that I did not have a legal basis for the request.
o
I strongly disagree with their position and I provided a valid
purpose for the requested materials.
On October 29, 2015 and concurrent with the launch of this consent solicitation, I delivered
a second request to inspect the Companys stockholder lists
pursuant to DGCL Section 220. o
Initially, the Company provided limited information purportedly in
satisfaction of the request, and only committed to
provide all of the legally required documents after I
filed suit in the Delaware Courts.
27 The Companys response reflect the boards lack of transparency and an unwillingness to respond to the legitimate concerns of stockholders. |
Value Proposition |
Value Proposition Puma shares still offer investors a value proposition. ExteNET Trial results: Supposed to present three-year (and hopefully four-year) data in
December 2015. According to Company CEO they expect widening of
curve separation (more survival effect) with
three-four-year data. Drugs previously approved in adjuvant setting with 2-3% separation according to management. UBS analyst rates as good
chance. Basis for Q1 16 NDA.
Carcinogenecity studies required by FDA: Late-2015 data expected to support Q1 16
NDA. Previous in vitro studies (ag genotox, Ames, etc.) were
negative.
Diarrhea: 40% Grade 3 in ExteNET trial without
loperamide. Historically 30-40% in other
trials; some evidence of 0-17% with high dose loparemide
prophylaxis for one-two weeks. Specific trial
data due to be released December 2015.
NDA: Submission for Q1 16 or sooner for
extended adjuvant indication.
Topline NSABP FB7 study results in press release December 2015
(neoadjuvant). Previous neoadjuvant trial
I-SPY-2.
HER2 mutated breast cancer results to be released December
2015.
Analyst expectations for ExteNET (e.g., restricted population, etc)
and valuation; valuations of other potential
claims/timing such as mutated HER2 BC, metastatic HER2+
BC, Neoadjuvant BC, NSCLC/other tumors from basket study;
prevention of brain mets. 29
Puma needs enhanced boardroom dynamics to ensure assets are fully
understood and valued by investors.
|
Potential Downside That Needs to Be Addressed Questions about the approvability of neratinib for extended adjuvant: o Clinical effect not large in light of high incidence of diarrhea.
o Protocol modified several times. o 40% diarrhea in treatment group raises issue of ascertainment bias.
o Only 61% of neratinib treated patients actually received the full year
treatment
(effect
on followup ). Even if neratinib looks more effective in subgroup analysis (e.g.
ER+), would likely require a separate trial for a label indication.
Other indications (mBC, neoadjuvant, etc.) may not present large commercial opportunities according to analysts. MDs may not prescribe neratinib and there may be better alternatives. 30 |
Our Plan to Improve Transparency The Nominees will work with management to improve transparency and manage street and investor
expectations, specifically by providing greater clarity with respect
to the following issues:
Assure full disclosure of ExteNET data (safety/efficacy, primary and
subgroup analyses), three and four year in December,
2015.
Confirm Q1 16 NDA for extended adjuvant and possible neoadjuvant
indication.
Address carcinogenicity data if problematic.
Events triggering payments of $187 million milestones due to PFE; cash flow to support R&D going forward,
and potential needs for additional financing.
Regulatory and other plans in place for either positive or negative ExteNET results, other claims, etc.
Correct any previous problematic statements and improve expectations provided by management going
forward.
Make management (as appropriate) other than CEO available on conference calls, meetings, etc.
Give complete outline of ongoing/planned studies, with firm reporting times.
Give complete report of all trial results (or topline at least) ready but heretofore unreleased (Pfizer and
Puma).
Show how all of the above line up with commercial expectations and valuations for various indications.
Update on Perjeta and other competitive threats. PR with oncology community in order to promote better understanding of drug effects and
prevention/management of side effects.
Disclose firm, detailed business plan and value enhancing strategy.
31 In this uncertain environment, transparency is especially important for
investors. Unfortunately, Puma has lacked transparency in the
past. We
seek to increase transparency and achieve full value for
stockholders. |
Business Initiatives Nominees Plan to Pursue The Nominees have outlined a set of business initiatives that address the following areas that they
have identified as critical to their oversight function and a
value-maximizing strategy: 32
While it is difficult to know precisely what actions should be taken without full data access, it is
quite clear that an overall comprehensive plan must be adopted and
executed expeditiously.
Unfortunately, the current board has not been fully transparent, and
has not engaged in public discussion of important issues
including: integrating/launching commercial planning,
manufacturing/finishing launch stocks of drug, looking at cash flow to
support this activity.
The current board has given no indication that such comprehensive
planning/implementation has been done.
The Nominees are committed to helping Puma develop a comprehensive
plan. 1.
Regulatory, Clinical and R&D Plan
2. Commercial/Competitive Situation, Label Indications and Valuations, Marketing and Sales Plan Preparatory
Activities
3. Manufacturing Considerations 4. Finance and Business Development 5. Investor Relations and Corporate Communications 6. Governance, Management Evaluation, Board Self-Study |
Minority Slate of Highly Qualified Nominees 33 |
Highly Qualified Slate of Nominees The Nominees have the experience and expertise to help guide Puma
down the complicated path to a successful launch of
neratinib: 34
Dr. Eshelman invested in Puma, undertook this consent solicitation,
and assembled an outstanding nominee slate because he
believes in the opportunity neratinib presents and is
committed to bringing this valuable drug to the market,
with the ultimate goal of improving cancer care for patients.
Highly qualified with excellent, relevant track records and significant
experience, comparing favorably with current directors.
Proven commitment to enhancing stockholder value and to patient care.
Addition of four new directors brings breadth and depth to the current
board of directors.
No incumbent directors will be removed. Each of the Nominees is independent of Dr. Eshelman and will fulfill their
fiduciary duties to act in the best interest of all Company
stockholders. |
Optimal Board Size: Nine is Fine Of 31 peer companies identified by either ISS, Capital IQ, or
Bloomberg:
Seven peers have boards with 9 directors. Notably, CEO Alan Auerbach sits on the board of Radius Health Inc., which has 9 members. Radius Healths market cap and product pipeline are similar to Pumas. 13 peer boards have nine or more members. NONE of Pumas peers has a board with fewer than 6 members. 35 ISS: A board of between nine and 12 members is considered ideal. Glass Lewis: [F]ive directors is almost always a minimum for an effective and properly functioning board. (2015 Puma Biotechnology Proxy Paper) Council of Institutional Investors Corporate Governance Policies: [A] board should have no fewer than five and no more than 15 members. Pumas current board would have you believe that a five member board is appropriate
for effectively governing the Company and that the boards
current size provides for efficient
decision-making. Pumas
claims
contradict
best practices and industry norms: Best Practices Industry Norms Numerous companies, including Fortune 500 companies, have boards with nine directors: United Natural Foods Inc., Windstream Holdings, Inc., Dr. Pepper Snapple Group, Inc., Lennar Corporation, Laboratory Corp of America Holdings, Cliffs
Natural Resources, PulteGroup Inc, Graybar Electric
Company Inc. Wynn Resorts, Limited, St. Jude Medical, Inc., Asbury Automotive Group, Big Lots, Inc., Tractor Supply Company, Insight Enterprises Inc., Quintiles Transnational Holdings Inc., Joy Global Inc., Lorillard, Inc., Sanmina, First American Financial
Corporation, Avery Dennison Corporation, Allergan Inc.,
Omnicare Inc., Dicks Sporting Goods, NCR Corporation, Waste Management, Inc., PPG Industries Inc., Marathon Oil Corporation, Caseys General Stores, Inc., Agilent Technologies Inc., Symantec Corporation, HollyFrontier Corporation, PBF Energy Inc., Kohls
Corporation, AbbVie Inc, Vertex Pharmaceuticals
Incorporated, Clovis Oncology, Inc., Tesoro Corporation, ARIAD
Pharmaceuticals, Inc., Dynavax Technologies Corporation, Lexicon Pharmaceuticals, Inc., Seattle Genetics, Inc., Tesaro, Inc., World Fuel Services Corporation, INTL FCStone Inc., Best Buy Co. Inc, Reliance Steel &
Aluminum Co., Stryker Corporation, Cognizant Technology
Solutions, Ball Corporation, Broadcom Corporation, CenterPoint Energy, Franklin Resources, Inc., Oaktree Capital Group LLC, Jarden Corporation, Mohawk Industries, Inc., UGI Corporation, The Pantry, Inc., Tyson Foods Inc., Jabil Circuit, Inc., AutoNation
Inc., Lear Corporation, Automatic Data Processing Inc.,
Liberty Interactive Corporation, Ameriprise Financial, Inc., Centene Corporation, Huntsman Corporation, Devon Energy Corporation, Publix Super Markets, Inc., Tech Data Corporation, RiteAid Corporation, National Oilwell Varco, Inc., Xerox Corporation, Arrow Electronics, Gentherm
Inc., Cree,
Inc, Belden Inc., Eastgroup Properties Inc., La-Z-Boy Inc.,
Amphenol Corporation, CVR Energy Corp, International
Bancshares Corp. 1-800-Flowers.com Inc. |
Current Boards Lack Of Experience Puma claims that the current board members posses a well diversified range of
experience and the current board has the experience
necessary to guide the Company through the next stages
of its development.
The current board has limited public company corporate governance and
oversight experience:
o The current board has collectively only served on 6 public boards other than Puma.
Of these companies, the five that remain public have a current combined market cap of $3.21B 1 , only slightly larger than Puma itself, of which Radius Health, Inc. accounts for $2.63 B. Their average market
cap was only $642.9M.
Only one of the other public companies is involved in cancer treatment.
Mr. Wilson serves on the board of Zosano, Inc. which since becoming public in 2015 is down
approximately 75%.
The stock price of Radius Health, Inc., where Mr. Auerbach is a director, fell 11% after the company
delayed an NDA filing for work health balance, and was
down 23% from its peak in July 2015. In
fact, the Nominees are far more experienced than the current board: The four Nominees have served on at least 20 public company boards more than 3x the five current board members. The four Nominees have served as Chairman or Lead Director on at least 10 public and private
company boards
10x
the five current board members.
The four Nominees have at least 110 years of combined relevant industry experience in the
pharmaceutical
and
biotechnology
industry
as officers and directors nearly double the five current board members purported 60 years of experience.
36 1. All calculations as of November 24, 2015. |
Nominee Experience 37 Puma claims that the Nominees provide no additional experience or expertise.
In fact, the Nominees will add extensive expertise that the current
board lacks: Drug Development and Regulatory
Current
Board Nominees Auerbachs experience at Cougar was limited to an in-licensed drug - early development was completed by PFE; Cougar was sold before any NDA filing. Three Nominees have extensive development experience: Dr. Seth A. Rudnick was responsible for the development and approval of two significant biologicals -
alpha interferon and erythopoietin, at Schering Plough/Biogen and
Johnson & Johnson, respectively.
Dr. Eshelman has supervised drug development and approvals in many
therapeutic areas.
Mr.
James M. Daly worked closely on clinical development, regulatory, and
oncology pipeline strategy at both Amgen Inc. and
Incyte Corporation. M&A
Current
Board Nominees No one on the current board has M&A experience other than Auerbach, who was involved in the sale of Cougar for $1.1B. Three Nominees have played key roles in large strategic transactions:
Dr. Eshelmans previous companies combined have sold for approximately $5 billion-
more than 5x
the
value of Auerbachs previous transaction that Puma touted in its
Revocation Statement.
Mr. Kenneth B. Lee, Jr. served as a director for three companies that
were sold in transactions with a combined value of
approximately $7.8B, and served on the Transaction Committee and Audit Committee of Pozen Inc. during its acquisition of Tribute Pharmaceuticals Canada Inc.
o Lee also founded the Center for Strategic Transactions at Ernst & Young LLP.
Mr. Daly played a key role in Amgens acquisitions of Micromet and BioVex, both oncology products.
Oncology
Current
Board Nominees No current board members have an advanced oncology background. All Nominees have significant oncology experience: Dr. Rudnick is a medical oncologist and completed an oncology fellowship at Yale University.
Daly served as head of Amgens oncology business. He oversaw the successful launches of five
oncology products and played a key role in two oncology product
acquisitions.
Dr.
Eshelman
has
served
on the boards of numerous companies that developed oncology products. Mr. Lee served on the board of an oncology company, OSI Pharmaceuticals, Inc., that had a marketed product and was acquired by Astellas Pharma, Inc. |
Nominee Experience 38 Investment Current Board Nominees Only one current board member has significant investment experience. Three Nominees have significant investment experience focused on breakthrough and early stage
companies, at funds with a venture capital model.
Dr. Eshelman: Founder of Eshelman Ventures LLC., a fund managing investments in numerous
healthcare companies.
Dr. Rudnick: 15 years of investment experience. Venture Partner at Canaan Partners, led investments in several breakthrough companies, including CombinatoRX, Esperion, Genaiisance
Pharmaceuticals and Pozen.
Mr. Lee: General Partner of Hatteras BioCapital Fund., L.P., where he managed portfolios valued at over $200M. Accounting Current Board Nominees No current board members have accounting experience except for Jay M. Moyes, who spent 12 years at KPMG LLP. Mr. Lee spent 28 years at Ernst & Young LLP. Titles included: Managing Director of Health Sciences Investment Banking Group & Co-Chairman
of International Life Sciences Practice.
Strong understanding of GAP and GAAP as applied to life sciences.
Unique experience structuring transactions at ALZA Corporation.
Marketing
Current
Board
Nominees
No current board
members have
significant marketing
experience.
Mr. Daly was responsible for marketing in his role as Chief
Commercial Officer at Incyte and during his time at
Amgen, where he served as SVP North America Commercial Operations and SVP Global Marketing and Commercial Development. During Dalys tenure at Incyte, annual oncology sales increased from $130M to $600M per year, and during his tenure as head of the oncology business at Amgen sales increased from $1B to
$4B. |
CAREER HIGHLIGHTS Age: 66 Founder of Eshelman Ventures, LLC, an investment company primarily focused on
healthcare companies.
Non-Executive Chairman of The
Medicines Company, a global biopharmaceutical
company focused on saving lives, alleviating suffering and
contributing to the economics of healthcare by focusing
on the leading acute and intensive care hospitals
worldwide Founded and served as CEO and Executive
Chairman of Pharmaceutical Product Development, Inc., a global contract pharmaceutical research organization. In 2008,
PPD was selected by Forbes for its Platinum 400 list of the best big
companies in America and as best-managed company in
health care equipment and services. PPD was sold to a
private equity consortium for $3.9 billion in December 2011. Served as Founding Chairman and largest shareholder of Furiex Pharmaceuticals,
Inc., which licensed and rapidly developed new medicines. Furiex was separated from PPD in a tax-free spin-off in June 2010 and sold to Forest Labs/Actavis for $1.1
billion in July 2014.
Served as Senior Vice President, Development of Glaxo, Inc., predecessor to GlaxoSmithKline plc, as well as in various management positions with Beecham
Laboratories and Boehringer Mannheim Pharmaceuticals.
Served on the executive committee of the Medical Foundation of North
Carolina and the Board of Trustees for
UNC-Wilmington. In 2011, Dr. Eshelman was appointed by the North Carolina General Assembly to serve on the Board of Governors for the state's
multi-campus university system as well as the North Carolina
Biotechnology Center. In addition, he chairs the board
of visitors for the School of Pharmacy at UNC-Chapel
Hill, which was named the UNC Eshelman School of Pharmacy in
recognition of his many contributions to the school and
the profession. Awards received by Dr. Eshelman include
the Davie and Distinguished Service Awards from UNC and
Outstanding Alumnus from both the UNC and University of
Cincinnati schools of pharmacy, as well as the North Carolina
Entrepreneur Hall of Fame Award.
FREDRIC N. ESHELMAN, PHARM.D.
39 NOMINEE EDUCATION Received Pharm.D. from the University of Cincinnati, and completed a residency at Cincinnati General Hospital and a B.S. in pharmacy from UNC- Chapel Hill. Dr. Eshelman is a graduate of the Owner/President Management program at Harvard Business School. |
CAREER HIGHLIGHTS Age: 53 Mr. Daly served as Executive Vice President and Chief Commercial Officer at Incyte Corporation, a biopharmaceutical company, from October 2012 until June 2015. Mr. Daly has served as one of Chimerix Incs directors since 2014. Prior to joining Incyte, Mr. Daly served as Senior Vice President of North America Commercial Operations and Global Marketing/Commercial Development at Amgen Inc.,
a
global
pharmaceutical
company,
where
he was employed from January 2002 to December 2011. Prior to his employment with Amgen, Mr. Daly was Senior Vice President and General Manager of the Respiratory/Anti-infective business unit at GlaxoSmithKline, where he was employed from June 1985 to December 2001. JAMES M. DALY 40 NOMINEE EDUCATION Received a B.S. and an M.B.A. degree from the University of Buffalo, The State University of New York. |
CAREER HIGHLIGHTS Age: 66 Dr. Seth Rudnick has been venture partner and previously general
partner at Canaan Partners, a
venture capital firm, since 1998, from which he is now
retired. Formerly, Dr. Rudnick was the Chief Executive
Officer and Chairman of CytoTherapeutics Inc., a company developing stem cell-based therapies. He helped found and served as the Head of Research and
Development for Ortho Biotech,
a division of Johnson & Johnson focusing on cancer and chronic illnesses. Dr. Rudnick currently serves on the boards of directors of the following
privately held biotechnology companies:
Envisia Therapeutics, LQ3 Therapeutics, Meryx Pharmaceuticals, for which he serves as Chairman, Liquidia Technologies, Inc., for which he serves as Chairman, and G1 Therapeutics, for which he serves as Executive Chairman. Dr. Rudnick also served on the board of Square 1, a public company
until its October 2015 acquisition by Pacific Western Bank.
Currently Dr. Rudnick
is a Clinical Adjunct Professor of Medicine at University of North
Carolina, Chapel Hill.
SETH A. RUDNICK, M.D.
41 NOMINEE EDUCATION Received M.D. from the University of Virginia. Completed a residency at Washington University Barnes Hospital and a fellowship in medical oncology at Yale University. Holds a B.A. in history from the University of Pennsylvania. |
CAREER HIGHLIGHTS Age: 67 Managing member of Hatteras BioCapital, LLC
and the general
partner of Hatteras BioCapital Fund,
L.P., a venture capital fund focusing on life
sciences companies. Mr. Lee most recently served as
managing director of the firms Health Sciences
Corporate Finance Group. Currently, Mr. Lee serves on
the boards of directors of the following publicly held
biotechnology companies: Biocryst Pharmaceuticals, Inc. and Pozen Inc., for which he serves as Lead Director, Chairman of the compensation committee and as a member of the audit committee. Mr. Lee also serves on the boards of directors of two private
companies,
Clinverse, Inc., and Clinipace Worldwide Inc., for which he serves as Chairman, and is a co-founder of the National
Conference on Biotechnology Venture.
Between 2002 and 2013, Mr. Lee served on the Boards of several
public companies:
Maxygen, Inc.; OSI Pharmaceuticals, Inc.; CV Therapeutics, Inc.; Abgenix, Inc. and Inspire Pharmaceuticals, Inc. Mr. Lee was formerly national director of the life science practice at
Ernst and Young LLP, where he advised biotechnology and pharmaceutical companies throughout the world on a wide range
of financial and strategic planning issues.
KENNETH B. LEE, JR.
42 NOMINEE EDUCATION Received a B.A. in from Lenoir-Rhyne College and an M.B.A. from the University of North Carolina at Chapel Hill. |
Contact 43 Legal Inquiries: Cadwalader, Wickersham & Taft LLP Richard Brand (212) 504-5757 richard.brand@cwt.com Investor Inquiries: Okapi Partners LLC Bruce Goldfarb/ Pat McHugh/ Lydia Mulyk (212) 297-0720 or (877) 869-0171 info@okapipartners.com Media Inquiries: Finsbury Kal Goldberg/ Chuck Nathan / Chris Ryall (646) 805-2000 kal.goldberg@finsbury.com charles.nathan@finsbury.com chris.ryall@finsbury.com |