e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One) |
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2006
or
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OFTHE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission file number: 000-24647
Dynavax Technologies Corporation
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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33-0728374
(IRS Employer
Identification No.) |
2929 Seventh Street, Suite 100
Berkeley, CA 94710-2753
(510) 848-5100
(Address, including Zip Code, and telephone number, including area code, of the registrants
principal executive offices)
Indicate by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Act). Yes o No
þ
As of July 31, 2006, the registrant had outstanding 30,587,769 shares of common stock.
INDEX
DYNAVAX TECHNOLOGIES CORPORATION
2
FORWARD-LOOKING STATEMENTS
This Quarterly report on Form 10-Q contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934
which are subject to a number of risks and uncertainties. Our forward-looking statements include
discussions regarding our business and financing strategies, future research and development,
preclinical and clinical product development efforts, intellectual property right and, ability to
commercialize our product candidates as well as the timing of the introduction of our products,
uncertainty regarding our future operating results and prospects for profitability. Our actual
results may vary materially from those in such forward-looking statements as a result of various
factors that are identified in Item 1A Risk Factors and elsewhere in this document. All
forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. We
assume no obligation to update any forward-looking statements.
This Quarterly Report on Form 10-Q includes trademarks and registered trademarks of Dynavax
Technologies Corporation. Products or service names of other companies mentioned in this Quarterly
Report on Form 10-Q may be trademarks or registered trademarks of their respective owners.
3
PART I. FINANCIAL STATEMENTS
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Dynavax Technologies Corporation
Condensed Consolidated Balance Sheets
(In thousands, except per share amounts)
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June 30, |
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December 31, |
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2006 |
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2005 |
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(unaudited) |
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(Note 1) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
10,090 |
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$ |
8,725 |
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Marketable securities |
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31,613 |
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66,385 |
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Investments held by Symphony Dynamo, Inc. |
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19,044 |
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Restricted cash |
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408 |
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408 |
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Accounts receivable |
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710 |
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689 |
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Prepaid expenses and other current assets |
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1,275 |
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1,277 |
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Total current assets |
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63,140 |
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77,484 |
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Property and equipment, net |
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4,986 |
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2,197 |
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Goodwill |
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2,312 |
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Other intangible assets, net |
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4,884 |
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Other assets |
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1,302 |
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412 |
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Total assets |
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$ |
76,624 |
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$ |
80,093 |
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Liabilities, noncontrolling interest and stockholders equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,417 |
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$ |
952 |
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Accrued liabilities |
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6,195 |
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3,841 |
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Deferred revenues |
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829 |
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750 |
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Total current liabilities |
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8,441 |
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5,543 |
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Other long-term liabilities |
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152 |
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187 |
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Noncontrolling interest in Symphony Dynamo, Inc. |
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9,728 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock: $0.001 par value; 5,000 shares authorized and no
shares issued and outstanding at June 30, 2006 and December 31,
2005 |
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Common stock: $0.001 par value; 100,000 shares authorized at June
30, 2006 and December 31, 2005; 30,588 and 30,482 shares issued
and outstanding at June 30, 2006 and December 31, 2005,
respectively |
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31 |
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30 |
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Additional paid-in capital |
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197,620 |
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192,840 |
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Deferred stock compensation |
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(2,467 |
) |
Accumulated other comprehensive loss: |
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Unrealized loss on marketable securities available-for-sale |
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(72 |
) |
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(144 |
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Cumulative translation adjustment |
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60 |
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(5 |
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Accumulated other comprehensive loss |
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(12 |
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(149 |
) |
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Accumulated deficit |
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(139,336 |
) |
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(115,891 |
) |
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Total stockholders equity |
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58,303 |
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74,363 |
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Total liabilities, noncontrolling interest and stockholders equity |
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$ |
76,624 |
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$ |
80,093 |
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See accompanying notes.
4
Dynavax Technologies Corporation
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenues: |
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Collaboration revenue |
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$ |
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$ |
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$ |
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$ |
12,199 |
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Services and license revenue |
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224 |
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224 |
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Grant revenue |
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305 |
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953 |
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593 |
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1,452 |
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Total revenues |
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529 |
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953 |
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817 |
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13,651 |
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Operating expenses: |
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Research and development |
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10,762 |
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7,493 |
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17,354 |
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13,148 |
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General and administrative |
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3,380 |
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2,473 |
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5,983 |
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4,813 |
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Acquired in-process research and development |
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4,180 |
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4,180 |
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Amortization of intangible assets |
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196 |
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196 |
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Total operating expenses |
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18,518 |
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9,966 |
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27,713 |
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17,961 |
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Loss from operations |
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(17,989 |
) |
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(9,013 |
) |
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(26,896 |
) |
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(4,310 |
) |
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Interest and other income, net |
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685 |
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434 |
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1,420 |
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801 |
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Loss including noncontrolling interest in Symphony Dynamo, Inc. |
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(17,304 |
) |
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(8,579 |
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(25,476 |
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(3,509 |
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Loss attributed to noncontrolling interest in Symphony
Dynamo, Inc. |
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2,031 |
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2,031 |
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Net loss |
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$ |
(15,273 |
) |
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$ |
(8,579 |
) |
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$ |
(23,445 |
) |
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$ |
(3,509 |
) |
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Basic and diluted net loss per share |
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$ |
(0.50 |
) |
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$ |
(0.35 |
) |
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$ |
(0.77 |
) |
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$ |
(0.14 |
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Shares used to compute basic and diluted net loss per share |
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30,536 |
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24,745 |
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30,524 |
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24,734 |
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See accompanying notes.
5
Dynavax Technologies Corporation
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
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Six Months Ended |
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June 30, |
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2006 |
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2005 |
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Operating activities |
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Net loss |
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$ |
(23,445 |
) |
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$ |
(3,509 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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(827 |
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387 |
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Loss attributed to noncontrolling interest in Symphony Dynamo, Inc. |
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(2,031 |
) |
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Acquired in-process research and development |
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4,180 |
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Amortization of intangible assets |
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196 |
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Gain on disposal of property and equipment |
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(50 |
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Accretion and amortization on marketable securities |
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169 |
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640 |
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Realized loss on sale of marketable securities |
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23 |
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Interest accrued on notes receivable from stockholders |
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(12 |
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Stock-based compensation expense |
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1,396 |
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653 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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468 |
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2,387 |
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Prepaid expenses and other current assets |
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2 |
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(740 |
) |
Other assets |
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(505 |
) |
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(10 |
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Accounts payable |
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242 |
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229 |
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Accrued liabilities |
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2,354 |
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|
178 |
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Deferred revenues |
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(87 |
) |
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(6,952 |
) |
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Net cash used in operating activities |
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(17,915 |
) |
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(6,749 |
) |
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Investing activities |
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Purchases of investments held by Symphony Dynamo, Inc. |
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(19,044 |
) |
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Cash paid for acquisition, net of cash acquired |
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(14,045 |
) |
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Purchases of marketable securities |
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(7,653 |
) |
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(35,712 |
) |
Maturities and sales of marketable securities |
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42,305 |
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31,190 |
|
Disposal (purchases) of property and equipment |
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41 |
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(363 |
) |
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Net cash provided by (used in) investing activities |
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1,604 |
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(4,885 |
) |
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Financing activities |
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Proceeds from purchase of noncontrolling interest by preferred
shareholders in Symphony Dynamo, Inc., net of fees |
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17,405 |
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Proceeds from employee stock purchase plan |
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57 |
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66 |
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Exercise of stock options |
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149 |
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6 |
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Repayment of notes receivable from stockholders |
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92 |
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Net cash provided by financing activities |
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17,611 |
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164 |
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Effect of exchange rate on cash and cash equivalents |
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65 |
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(4 |
) |
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Net increase (decrease) increase in cash and cash equivalents |
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1,365 |
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(11,474 |
) |
Cash and cash equivalents at beginning of period |
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8,725 |
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16,590 |
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Cash and cash equivalents at end of period |
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$ |
10,090 |
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$ |
5,116 |
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Supplemental disclosure of non-cash investing and financing activities |
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Warrants issued in conjunction with the Symphony Dynamo, Inc. transaction |
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$ |
5,646 |
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$ |
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Change in unrealized loss on marketable securities |
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$ |
72 |
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$ |
(18 |
) |
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Change in cumulative translation adjustment |
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$ |
65 |
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$ |
(4 |
) |
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Exercise of stock options |
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$ |
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$ |
200 |
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Repurchase of common stock for exercise of stock options |
|
$ |
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$ |
(200 |
) |
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|
See accompanying notes.
6
Dynavax Technologies Corporation
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Organization and Summary of Significant Accounting Policies
Dynavax Technologies Corporation (Dynavax or the Company) is a biopharmaceutical company
that discovers, develops and intends to commercialize innovative products to treat and prevent
allergies, infectious diseases, cancer and chronic inflammatory diseases using versatile,
proprietary approaches that alter immune system responses in highly specific ways.
Basis of Presentation
Our accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial information and
pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In our opinion, these
unaudited condensed consolidated financial statements include all adjustments, consisting only of
normal recurring adjustments, which the Company considers necessary to fairly state our financial
position and the results of our operations and cash flows. Interim-period results are not
necessarily indicative of results of operations or cash flows for a full-year period. The condensed
consolidated balance sheet at December 31, 2005 has been derived from audited financial statements
at that date, but does not include all disclosures required by U.S. generally accepted accounting
principles for complete financial statements.
These unaudited condensed consolidated financial statements and the notes accompanying them
should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31,
2005 as filed with the Securities and Exchange Commission (SEC) on March 16, 2006.
The unaudited condensed consolidated financial statements include the accounts of Dynavax and
our wholly-owned subsidiaries as well as a variable interest entity, Symphony Dynamo, Inc., for
which we are the primary beneficiary as defined by Financial Accounting Standards Board (FASB)
Interpretation No. 46 (revised 2003), Consolidation of Variable Interest Entities (FIN 46R). All
significant intercompany accounts and transactions have been eliminated. The Company operates in
one business segment, which is the discovery and development of biopharmaceutical products.
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
amounts reported in the unaudited condensed consolidated financial statements and accompanying
notes. Actual results may differ from these estimates.
Critical Accounting Policies
The Company believes that there have been no significant changes in its critical accounting
policies during the six months ended June 30, 2006 as compared with those disclosed in its Annual
Report on Form 10-K for the year ended December 31, 2005, except as discussed below.
Revenue Recognition
We recognize revenue from collaborative agreements, the performance of research and
development and contract manufacturing services, royalty and license fees and grants. We recognize
revenue when there is persuasive evidence that an arrangement exists, delivery has occurred or
services have been rendered, the price is fixed or determinable and collectibility is reasonably
assured.
Revenues from collaboration and research and development service agreements are recognized as
work is performed. Any amounts received in advance of performance are recorded as deferred revenue
and recognized as earned over the estimated term of the performance obligation. Revenue from
milestones with substantive performance risk is recognized upon achievement of the milestone. All
revenue recognized to date under these collaborations and milestones has been nonrefundable.
Revenues from the manufacturing and sale of vaccine and other materials at the Dynavax Europe facility
are recognized upon meeting the criteria for substantial performance and acceptance by the customer. Revenues from license fees and royalty payments are
7
recognized when earned; up-front nonrefundable fees where the Company has no continuing
performance obligations are recognized as revenues when collection is reasonably assured.
Grant revenue from government and private agency grants are recognized as the related research
expenses are incurred and to the extent that funding is approved. Additionally, we recognize
revenue based on the facilities and administrative cost rate reimbursable per the terms of the
grant awards. Any amounts received in advance of performance are recorded as deferred revenue until
earned.
Stock-Based Compensation
On January 1, 2006, the Company adopted the fair value recognition provisions of Statement of
Financial Accounting Standards 123R, Share-Based Payment (FAS 123R) using the
modified-prospective transition method. Under this transition method, compensation cost includes:
(a) compensation cost for all share-based payments granted prior to, but not yet vested as of
January 1, 2006, based on the grant date fair value estimated in accordance with the original
provisions of FAS 123 and (b) compensation cost for all share-based payments granted subsequent to
January 1, 2006, based on the grant date fair value estimated in accordance with the provisions of
FAS 123R. Results for prior periods have not been restated.
Acquired In-process Research and Development
We allocate the purchase price of acquisitions based on the estimated fair value of the assets
acquired and liabilities assumed. To assist in determining the value of the acquired in-process
research and development (in-process R&D) and certain other intangibles associated
with the Rhein Biotech GmbH transaction discussed in Note 2, we
obtained a third party valuation as of the acquisition date. We used the
income approach and the cost approach to value in-process research and development. The income
approach is based on the premise that the value of an asset is the present value of the future
earning capacity that is available for distribution to the investors in the asset. We perform a
discounted cash flow analysis, utilizing anticipated revenues, expenses and net cash flow forecasts
related to the technology. The cost approach is based on the theory that a prudent investor would
pay no more than the cost of constructing a similar asset of like utility at prices applicable at
the time of the appraisal. We estimate the costs involved in re-creating the technology using the
historical cost and effort applied to the development of the technology prior to the valuation
date. Given the high risk associated with the development of new drugs, we adjust the revenue and
expense forecasts to reflect the probability and risk of advancement through the regulatory
approval process based on the stage of development in the regulatory process. Such a valuation
requires significant estimates and assumptions. We believe the estimated fair value assigned to the
in-process R&D and other intangibles is based on reasonable assumptions.
However, these assumptions may be incomplete or inaccurate, and unanticipated events and
circumstances may occur. Additionally, estimates for the purchase price allocation may change as
subsequent information becomes available.
Goodwill and Other Intangible Assets
Goodwill amounts are recorded as the excess purchase price over tangible assets, liabilities
and intangible assets acquired based on their estimated fair value, by applying the purchase method
of accounting. The valuation in connection with the initial purchase price allocation and the
ongoing evaluation for impairment of goodwill and intangible assets requires significant management
estimates and judgment. The purchase price allocation process requires management estimates and
judgment as to expectations for various products and business strategies. If any of the significant
assumptions differ from the estimates and judgments used in the purchase price allocation, this
could result in different valuations for goodwill and intangible assets. The Company evaluates
goodwill for impairment on an annual basis and on an interim basis if events or changes in
circumstances between annual impairment tests indicate that the asset might be impaired as required
by SFAS No. 142, Goodwill and Other Intangible Assets.
8
Valuation of Long-lived Assets
Long-lived assets to be held and used, including property and equipment and identified
intangible assets, are reviewed for impairment in accordance with SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets whenever events or changes in circumstances indicate
that the carrying value of such assets may not be recoverable. Factors we consider important that
could indicate the need for an impairment review include the following:
|
|
|
significant changes in the strategy for our overall business; |
|
|
|
|
significant underperformance relative to expected historical or projected future operating results; |
|
|
|
|
significant changes in the manner of our use of acquired assets; |
|
|
|
|
significant negative industry or economic trends; |
|
|
|
|
significant decline in our stock price for a sustained period; and |
|
|
|
|
our market capitalization relative to net book value. |
Determination of recoverability is based on an estimate of undiscounted cash flows resulting
from the use of the asset and its eventual disposition. Measurement of impairment charges for
long-lived assets that management expects to hold and use are based on the fair value of such
assets.
Consolidation of Variable Interest Entities
Under FIN 46R, Consolidation of
Variable Interest Entities, arrangements that are not controlled through voting or similar rights are accounted for as
variable interest entities (VIEs). An enterprise is required to consolidate a VIE if it is the primary beneficiary of the VIE.
The enterprise that is deemed to absorb a majority of the expected losses or receive a majority of expected residual returns of
the VIE is considered the primary beneficiary.
Based on the provisions of FIN 46R,
we have concluded that under certain circumstances when we enter into agreements that contain an option to purchase assets
or equity securities from an entity, or enter into an arrangement with a financial partner for the formation of joint
ventures which engage in research and development projects, a VIE may be created. For each VIE created, we compute expected
losses and residual returns based on the probability of future cash flows. If we are determined to be the primary beneficiary
of the VIE, the assets, liabilities and operations of the VIE will be consolidated with our financial statements. Our
consolidated financial statements include the accounts of Symphony Dynamo, Inc. discussed in Note 4.
2. Acquisition of Rhein Biotech GmbH
On April 21, 2006, the Company completed the acquisition of Rhein Biotech GmbH (Rhein) from
Rhein Biotech NV, a subsidiary of Berna Biotech AG (Berna). As a result, the financial position and
results of operations of Rhein have been included in our condensed consolidated financial
statements as of June 30, 2006 and for the period from April 22, 2006 through June 30, 2006. Rhein,
located in Düsseldorf, Germany, became a wholly-owned subsidiary which the Company refers to as
Dynavax Europe. Through this acquisition, Dynavax gained ownership of a current Good Manufacturing
Practice (GMP)-certified vaccine manufacturing facility in the European Union, control over the
production and supply of its hepatitis B surface antigen and potentially other antigens to support
clinical and commercial programs, management and personnel with expertise in biopharmaceutical
product development and production and a complementary pipeline of vaccine and antiviral products.
Upon closing of the transaction, Dynavaxs license and supply agreement with Berna for the supply
of hepatitis B surface antigen used in the Companys HEPLISAV vaccine was terminated, eliminating
Bernas option to commercialize HEPLISAV.
Under the terms of the transaction, the Company purchased all of the outstanding capital stock
of Rhein, which included the satisfaction of outstanding debt and certain employee and acquisition
costs for an aggregate purchase price of approximately $14.6 million. The components of the
purchase price are summarized in the following table (in thousands):
|
|
|
|
|
Consideration and acquisition costs: |
|
|
|
|
Cash paid for common stock |
|
$ |
7,925 |
|
Cash paid to satisfy outstanding debt |
|
|
4,550 |
|
Employee costs |
|
|
745 |
|
Acquisition costs |
|
|
1,338 |
|
|
|
|
|
Total purchase price |
|
$ |
14,558 |
|
|
|
|
|
Under the purchase method of accounting, the total purchase price is allocated to the tangible
and identifiable intangible assets acquired and liabilities assumed based on their estimated fair
values as of the date of the acquisition. Certain purchase accounting adjustments were made in
order to state the tangible assets acquired and liabilities assumed at their estimated fair values
and in accordance with the Companys accounting policies and U.S. generally accepted accounting
principles. These adjustments primarily impacted deferred revenue and acquired property and
equipment. The Company utilized a third party valuation expert to assess the fair value of the
identifiable intangible assets acquired, as well as in-process
research and development. The purchase price was allocated using
information available at the time of acquisition. The Company may
adjust the preliminary purchase price relating to good will, intangible assets and in-process R&D after obtaining more
information regarding, among other things, asset valuations,
liabilities assumed and revisions of preliminary estimates. The excess
of purchase price over the aggregate fair values was recorded as goodwill.
9
The preliminary allocation of the total purchase price is as follows (in thousands):
|
|
|
|
|
Allocation of purchase price: |
|
|
|
|
Cash and cash equivalents |
|
$ |
513 |
|
Accounts receivable |
|
|
489 |
|
Other current assets |
|
|
385 |
|
Property, plant and equipment |
|
|
3,092 |
|
Goodwill |
|
|
2,312 |
|
Intangible assets |
|
|
5,080 |
|
In-process research and development |
|
|
4,180 |
|
Accounts payable |
|
|
(273 |
) |
Deferred revenue |
|
|
(166 |
) |
Other current liabilities |
|
|
(1,054 |
) |
|
|
|
|
Total purchase price |
|
$ |
14,558 |
|
|
|
|
|
Intangible assets consist primarily of manufacturing process, customer relationships, and
developed technology. The manufacturing process derives from the methods for making proteins in Hansenula
yeast, which is a key component in the production of hepatitis B vaccine. The customer
relationships derive from Rheins ability to sell existing, in-process and future products to its
existing customers. The developed technology derives from a licensed
hepatitis B vaccine product. Purchased intangible assets other than goodwill are amortized on a
straight-line basis over their respective useful lives. The following table presents details of the
purchased intangible assets acquired as part of the acquisition (in thousands, except years):
|
|
|
|
|
|
|
|
|
Estimated Useful Life |
|
|
|
Intangible Assets |
|
(in Years) |
|
Amount |
|
Manufacturing process |
|
5 |
|
$ |
3,670 |
|
Customer relationships |
|
5 |
|
|
1,230 |
|
Developed technology |
|
7 |
|
|
180 |
|
|
|
|
|
|
|
Total |
|
|
|
$ |
5,080 |
|
|
|
|
|
|
|
The following tables present details of the Companys total purchased intangible assets (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
June 30, 2006 |
|
Gross |
|
|
Amortization |
|
|
Net |
|
Manufacturing process |
|
$ |
3,670 |
|
|
$ |
143 |
|
|
$ |
3,527 |
|
Customer relationships |
|
|
1,230 |
|
|
|
48 |
|
|
|
1,182 |
|
Developed technology |
|
|
180 |
|
|
|
5 |
|
|
|
175 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
5,080 |
|
|
$ |
196 |
|
|
$ |
4,884 |
|
|
|
|
|
|
|
|
|
|
|
The estimated future amortization expense of purchased intangible assets is as follows (in
thousands):
|
|
|
|
|
Year ending December 31, |
|
|
|
|
2006 (remaining six months) |
|
$ |
503 |
|
2007 |
|
|
1,006 |
|
2008 |
|
|
1,006 |
|
2009 |
|
|
1,005 |
|
2010 |
|
|
1,005 |
|
Thereafter |
|
|
359 |
|
|
|
|
|
Total |
|
$ |
4,884 |
|
|
|
|
|
The Companys methodology for allocating the purchase price to in-process R&D is determined through established valuation techniques in the
biotechnology industry. In-process R&D is expensed upon acquisition because technological
feasibility has not been established at that date and no future alternative uses exist. Total
in-process R&D expense was $4.2 million for both the three and six months ended June 30, 2006.
The unaudited financial information in the table below summarizes the combined results of
operations of Dynavax and Rhein, on a pro forma basis, as though the companies had been combined as
of January 1, 2006 and 2005. The pro forma financial information is
10
presented for informational purposes only and is not indicative of the results of operations
that would have been achieved if the acquisition had taken place at the beginning of each of the
periods presented. The pro forma financial information for the three and six months ended June 30,
2006 includes a charge for the write off of in-process R&D. The pro forma financial information for
all periods presented also includes the purchase accounting adjustments on Rheins revenue,
adjustments to depreciation on acquired property and equipment, and amortization charges from
acquired intangible assets.
The following table summarizes the unaudited pro forma financial information (in thousands,
except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Revenues |
|
$ |
571 |
|
|
$ |
1,702 |
|
|
$ |
1,503 |
|
|
$ |
15,182 |
|
Net loss |
|
$ |
(15,794 |
) |
|
$ |
(9,764 |
) |
|
$ |
(25,733 |
) |
|
$ |
(5,907 |
) |
Basic and diluted earnings per share |
|
$ |
(0.52 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.84 |
) |
|
$ |
(0.24 |
) |
3. Collaborative Research and Development Agreements
In March 2005, the Company agreed to end its collaboration with UCB Farchim, S.A. (UCB) and
regained full rights to its allergy program. During the second quarter of 2005, the Company
received cash payments in satisfaction of outstanding receivables due from UCB and obligations owed
by UCB under the collaboration. Collaboration revenue for the six months ended June 30, 2005
included accelerated recognition of $7.0 million in deferred revenue as the Company had no ongoing
obligations under the collaboration. Collaboration revenue from UCB amounted to $12.2 million
during the six months ended June 30, 2005.
In 2003, the Company was awarded government grants totaling $8.3 million to be received over
as long as three and one-half years, assuming annual review criteria are met, to fund research and
development of certain biodefense programs. Revenue associated with these grants is recognized as
the related expenses are incurred. For the six months ended June 30, 2006 and 2005, the Company
recognized revenue of approximately $0.5 million and $1.4 million, respectively, associated with
government grants for biodefense programs.
In the fourth quarter of 2004, the Company was awarded $0.5 million from the Alliance for
Lupus Research to be received during 2005 and 2006 to fund research and development of new
treatment approaches for lupus. For each of the six months ended June 30, 2006 and 2005, the
Company recognized revenue of approximately $0.1 million associated with the lupus grant.
4. Symphony Dynamo, Inc.
On April 18, 2006, the Company entered into a series of related agreements with Symphony
Capital Partners, LP to advance specific Dynavax ISS-based programs for cancer, hepatitis B therapy
and hepatitis C therapy through certain stages of clinical development. Pursuant to the agreements,
Symphony Dynamo, Inc. (SDI) has agreed to invest $50.0 million to fund the clinical development of
these programs and we have licensed to SDI our intellectual property rights related to these
programs. SDI is a wholly-owned subsidiary of Symphony Dynamo Holdings LLC (Holdings), which
provided $20.0 million in funding to SDI at closing, and which is obligated to fund an additional
$30.0 million in one year following closing. We continue to be primarily responsible for the
development of these programs.
In accordance with FIN 46R, we have determined that SDI is a variable interest entity for
which we are the primary beneficiary. As a result, the financial position and results of operations
of SDI have been included in our condensed consolidated financial
statements as of June 30, 2006 and for the
period from April 18, 2006 through June 30, 2006. Accordingly, the investments held by SDI and noncontrolling interest in
SDI in the condensed consolidated balance sheet include the initial $20.0 million of funding, less
funds spent to date on the development of the programs. The noncontrolling interest in SDI, which
will continue to be reduced by SDIs losses, was also reduced initially by (i) the structuring fee
and other closing costs of $2.6 million, and (ii) the value assigned to the warrants issued to
Holdings upon closing of $5.6 million.
Reimbursable
expenses related to the SDI programs were $2.0 million for the
period from April 18, 2006 through June 30, 2006, as reflected in the loss attributed to the noncontrolling interest in
SDI.
Pursuant to the agreements, we issued to Holdings a five-year warrant to purchase 2,000,000
shares of Dynavax common stock at
11
$7.32 per share, representing a 25% premium over the applicable 60-day trading range average
of $5.86 per share. The warrant exercise price is subject to reduction to $5.86 per share under
certain circumstances. The warrant may be exercised or surrendered
for a cash payment upon consummation of an all cash merger or
acquisition of Dynavax, the obligation for which would be settled by
the surviving entity. The warrant issued upon closing was assigned a value of $5.6 million using
the Black-Scholes valuation model, which has been recorded as a reduction in the noncontrolling
interest in SDI and an increase in additional paid in capital.
In consideration for the warrant, Dynavax received an exclusive purchase option (Purchase
Option) to acquire all of the programs through the purchase of all of the equity in SDI during the
five-year term at specified prices. The Purchase Option exercise price is payable in cash or a
combination of cash and shares of Dynavax common stock, at Dynavaxs sole discretion. Dynavax also
has an option to purchase either the hepatitis B or hepatitis C program (Program Option) during the
first year of the agreement. The Program Option is exercisable at our sole discretion at a price
which is payable in cash only and will be fully creditable against the exercise price for any
subsequent exercise of the Purchase Option. If the Company does not exercise its exclusive right to
purchase some or all of the programs licensed under the agreement, the intellectual property rights
to the programs at the end of the development period will remain with SDI.
5. Commitments
The Company leases its facilities in Berkeley, California and Düsseldorf, Germany under
operating leases that expire in September 2014 (Berkeley Lease) and August 2009 (Düsseldorf Lease),
respectively. The Berkeley Lease can be terminated at no cost to the Company in September 2009 but
otherwise extends automatically until September 2014. The Berkeley Lease provides for periods of
escalating rent. The total cash payments over the life of the lease were divided by the total
number of months in the lease period and the average rent is charged to expense each month during
the lease period. In addition, our Berkeley Lease provided a tenant improvement allowance of $0.4
million, which is considered a lease incentive and accordingly, has been included in accrued
liabilities and other long-term liabilities in the condensed consolidated balance sheets as of June
30, 2006 and December 31, 2005. The Berkeley Lease incentive is amortized as an offset to rent
expense over the estimated initial lease term, through September 2009. Total net rent expense
related to our operating leases for the six months ended June 30, 2006 and 2005, was $0.8 million
and $0.7 million, respectively. Deferred rent was $0.2 million as of June 30, 2006.
We have entered into a sublease agreement under the Berkeley Lease for a certain portion of
the leased space with scheduled payments to the Company totaling $0.4 million annually through
2007. This sublease agreement includes an option for early termination by the Company in August
2006 but otherwise extends automatically until August 2007.
Future minimum payments under the non-cancelable portion of our operating leases at June 30,
2006, excluding payments from the sublease agreement, are as follows (in thousands):
|
|
|
|
|
Year ending December 31, |
|
|
|
|
2006 |
|
$ |
1,051 |
|
2007 |
|
|
2,139 |
|
2008 |
|
|
2,192 |
|
2009 |
|
|
1,487 |
|
|
|
|
|
|
|
$ |
6,869 |
|
|
|
|
|
During the fourth quarter of 2004, we established a letter of credit with Silicon Valley Bank
as security for our Berkeley Lease in the amount of $0.4 million. The letter of credit remained
outstanding as of June 30, 2006 and is collateralized by a certificate of deposit which has been
included in restricted cash in the condensed consolidated balance sheets as of June 30, 2006 and
December 31, 2005. Under the terms of the Berkeley Lease, if the total amount of our cash, cash
equivalents and marketable securities falls below $20.0 million for a period of more than 30
consecutive days during the lease term, the amount of the required security deposit will increase
to $1.1 million, until such time as our projected cash and cash equivalents will exceed $20.0
million for the remainder of the lease term, or until our actual cash and cash equivalents remains
above $20.0 million for a period of 12 consecutive months.
In addition to the non-cancelable commitments included above, we have entered into contractual
arrangements that obligate us to make payments to the contractual counterparties upon the
occurrence of future events. In the normal course of operations, we have entered into license and
other agreements and intend to continue to seek additional rights relating to compounds or
technologies in connection with our discovery, manufacturing and development programs. Under the
terms of the agreements, the Company may be required to pay future up-front fees, milestones and
royalties on net sales of products originating from the licensed technologies. We consider these
potential obligations to be contingent and have summarized all significant arrangements below.
12
We rely on research institutions, contract research organizations (CRO), clinical
investigators and clinical manufacturers. As of June 30, 2006, under the terms of our agreements,
we are obligated to make future payments as services are provided of approximately $33 million
through 2008. These agreements are terminable by us upon written notice. We are generally only
liable for actual effort expended by the organizations at any point in time during the contract,
subject to certain termination fees and penalties.
The Company entered into a series of exclusive license agreements with the Regents of the
University of California in March 1997 and October 1998. These agreements provide the Company with
certain technology and related patent rights and materials related to ISS, TNF-alpha inhibitors,
vaccines using DNA and immunoregulatory sequences. Under the terms of the agreements, the Company
pays annual license or maintenance fees and will be required to pay milestones and royalties on net
sales of products originating from the licensed technologies.
On April 21, 2006, Rhein and Green Cross Vaccine
Corp. entered into an exclusive license agreement whereby Green Cross granted Rhein an exclusive
license relating to a hepatitis B vaccine. In exchange, Rhein will be required to pay Green Cross a
certain profit share until Green Crosss development costs for the product are recouped and a
certain profit share for a specified period of time after the hepatitis B product is launched in
Europe and Asia.
In December 2004, Rhein entered into a joint venture agreement under which it is obligated to
perform research and development services up to a maximum of 1.5 million Euro, or approximately
$2.0 million, related to the development of a vaccine for cytomegalovirus. As of June 30, 2006, the
remaining obligation was approximately $1.0 million.
6. Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number
of common shares outstanding during the period. Diluted net loss per share is computed by dividing
the net loss by the weighted-average number of common shares outstanding during the period and
potentially dilutive common shares using the treasury-stock method. For purposes of this
calculation, common stock subject to repurchase and incremental common shares issuable upon the
exercise of stock options and warrants are considered to be potentially dilutive common shares and
are not included in the calculation of diluted net loss per share attributable to common
stockholders because their effect is dilutive.
The following is a reconciliation of the numerator and denominator used in the basic and
diluted net loss per share computations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(15,273 |
) |
|
|
(8,579 |
) |
|
|
(23,445 |
) |
|
|
(3,509 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
common shares
outstanding used
for basic and
diluted net loss
per share |
|
|
30,536 |
|
|
|
24,745 |
|
|
|
30,524 |
|
|
|
24,734 |
|
7. Stockholders Equity
As of June 30, 2006, the Company had three share-based compensation plans: the 1997 Equity
Incentive Plan; the 2004 Stock Incentive Plan, which includes the 2004 Non-Employee Director Option
Program; and the 2004 Employee Stock Purchase Plan.
Prior to January 1, 2006, the Company accounted for its share-based compensation plans under
the recognition and measurement provisions of APB Opinion No. 25, Accounting for Stock Issued to
Employees (APB 25), and related interpretations, as permitted by FASB Statement No. 123,
Accounting for Stock-Based Compensation (FAS 123). On January 1, 2006, the Company adopted the
fair value recognition provisions of FAS 123R using the modified-prospective transition method.
Under this transition method, compensation cost includes: (a) compensation cost for all share-based
payments granted prior to, but not yet vested as of January 1, 2006, based on the grant date fair
value estimated in accordance with the original provisions of FAS 123, and (b) compensation cost
for all share-based payments granted subsequent to January 1, 2006, based on the grant date fair
value estimated in accordance with the provisions of FAS 123R. Results for prior periods have not
been restated.
13
As a result of the adoption of FAS 123R, the Company reduced its deferred stock compensation
balance and additional paid in capital previously associated with APB 25 accounting by $2.5 million
as of January 1, 2006. Also as a result of adopting FAS123R, the Companys loss before income taxes and net loss for the three and six months ended June 30, 2006
are higher by $0.5 million and $0.8 million, respectively, than if the Company had continued to account for share-based compensation under APB 25. Basic and diluted net
loss per share for the three and six months ended June 30, 2006 are higher by $0.02 and $0.03, respectively, than if the Company had continued to account for share-based compensation under APB 25.
The following table illustrates the effect on net loss and net loss per share if the Company
had applied the fair value recognition provisions of FAS 123 to options granted under the Companys
share-based compensation plans during the three and six months ended June 30, 2005 (in thousands,
except per share amounts). For purposes of this pro forma disclosure, the fair value of the options
is estimated using the Black-Scholes option valuation model and amortized to expense on a
straight-line basis over the vesting periods of the options.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2005 |
|
|
2005 |
|
Net loss, as reported |
|
$ |
(8,579 |
) |
|
$ |
(3,509 |
) |
Add: Stock-based employee compensation expense included in net loss |
|
|
336 |
|
|
|
668 |
|
Less: Stock-based employee compensation expense determined under
the fair value based method |
|
|
(716 |
) |
|
|
(1,410 |
) |
|
|
|
|
|
|
|
Net loss, pro forma |
|
$ |
(8,959 |
) |
|
$ |
(4,251 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted net loss, as reported |
|
$ |
(0.35 |
) |
|
$ |
(0.14 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss, pro forma |
|
$ |
(0.36 |
) |
|
$ |
(0.17 |
) |
|
|
|
|
|
|
|
Under the Companys stock-based compensation plans, option awards generally vest over a 4-year
period contingent upon continuous service and expire 10 years from the date of grant (or earlier
upon termination of continuous service). The fair value of each option is estimated on the date of
grant using the Black-Scholes option valuation model and the following weighted-average
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Stock |
|
|
|
Employee Stock Options |
|
|
Purchase Plan |
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Weighted-average fair value |
|
$ |
3.79 |
|
|
$ |
2.28 |
|
|
$ |
3.99 |
|
|
$ |
3.85 |
|
|
$ |
2.65 |
|
|
$ |
3.68 |
|
Risk-free interest rate |
|
|
5.1 |
% |
|
|
3.9 |
% |
|
|
4.8 |
% |
|
|
3.5 |
% |
|
|
4.7 |
% |
|
|
3.2 |
% |
Expected life (in years) |
|
|
5.8 |
|
|
|
4 |
|
|
|
5.7 |
|
|
|
4 |
|
|
|
1.2 |
|
|
|
1.7 |
|
Volatility |
|
|
0.8 |
|
|
|
0.7 |
|
|
|
0.8 |
|
|
|
0.7 |
|
|
|
0.7 |
|
|
|
0.7 |
|
Expected dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected volatility is based on historical volatility of the Companys stock and comparable
peer data. The expected life of options granted is estimated based on historical option exercise
and employee termination data. Executive level employees, who hold a majority of the options
outstanding, and non-executive level employees were each found to have similar historical option
exercise and termination behavior and thus were grouped and considered separately for valuation
purposes. The risk-free rate for periods within the contractual life of the option is based on the
U.S. Treasury yield curve in effect at the time of grant.
The Company recognized the following amounts of stock-based compensation expense (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Employee and director stock-based compensation expense |
|
$ |
731 |
|
|
$ |
336 |
|
|
$ |
1,388 |
|
|
$ |
668 |
|
Non-employee stock-based compensation expense |
|
|
(1 |
) |
|
|
|
|
|
|
8 |
|
|
|
(15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
730 |
|
|
$ |
336 |
|
|
$ |
1,396 |
|
|
$ |
653 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair value of the options is amortized to expense on a straight-line basis over the
vesting periods of the options. Compensation expense recognized for the three and six months ended
June 30, 2006 was based on awards ultimately expected to vest and reflects estimated forfeitures at
an annual rate of 11%. As of June 30, 2006, the total unrecognized compensation cost related to
non-vested
14
options granted amounted to $7.7 million, which is expected to be recognized over the options
remaining weighted-average vesting period of 1.7 years.
Activity under the our stock option plans was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average |
|
|
|
Options Available |
|
|
Number of Options |
|
|
Exercise Price Per |
|
|
|
for Grant |
|
|
Outstanding |
|
|
Share |
|
Balance at December 31, 2005 |
|
|
2,831,668 |
|
|
|
2,598,797 |
|
|
$ |
4.43 |
|
Options authorized |
|
|
400,000 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
(1,271,600 |
) |
|
|
1,271,600 |
|
|
$ |
5.72 |
|
Options exercised |
|
|
|
|
|
|
(94,268 |
) |
|
$ |
1.56 |
|
Options cancelled: |
|
|
|
|
|
|
|
|
|
|
|
|
Options forfeited (unvested) |
|
|
195,077 |
|
|
|
(195,077 |
) |
|
$ |
5.20 |
|
Options expired (vested) |
|
|
59,459 |
|
|
|
(59,459 |
) |
|
$ |
3.27 |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 |
|
|
2,214,604 |
|
|
|
3,521,593 |
|
|
$ |
4.95 |
|
|
|
|
|
|
|
|
|
|
|
|
Total options exercised during the six months ended June 30, 2006 and June 30, 2005 was 94,268
and 136,114, respectively. The total intrinsic value of the options exercised during the six months
ended June 30, 2006 and June 30, 2005 was approximately $0.4 million and $0.8 million,
respectively. No income tax benefits were realized by the Company in the six months ended June 30,
2006 or June 30, 2005, as the Company reported an operating loss.
The following table summarizes outstanding options that are vested and expected to vest, and
options exercisable under our stock option plans as of June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- Average |
|
|
|
|
|
|
|
|
|
|
Weighted-Average |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Exercise Price Per |
|
|
Contractual Term |
|
|
Aggregate Intrinsic |
|
|
|
Number of Shares |
|
|
Share |
|
|
(in years) |
|
|
Value |
|
Outstanding options (vested and expected to vest) |
|
|
3,124,807 |
|
|
$ |
4.86 |
|
|
|
8.3 |
|
|
$ |
1,696,121 |
|
Options exercisable |
|
|
1,241,250 |
|
|
$ |
3.98 |
|
|
|
7.2 |
|
|
$ |
1,291,032 |
|
Employee Stock Purchase Plan
As of June 30, 2006, 496,000 shares were reserved and approved for issuance under the Purchase
Plan, subject to adjustment for a stock split, or any future stock dividend or other similar change
in the Companys common stock or capital structure. During the six months ended June 30, 2006,
employees acquired 11,352 shares of our common stock under the Purchase Plan. At June 30, 2006,
449,956 shares of our common stock remained available for future purchases.
15
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following Managements Discussion and Analysis of Financial Condition and Results of
Operations contains forward-looking statements that involve a number of risks and uncertainties.
Our actual results could differ materially from those indicated by forward-looking statements as a
result of various factors, including but not limited to those set forth below and in Risk Factors
as well as elsewhere in this document.
This discussion should be read in conjunction with the unaudited Condensed Consolidated
Financial Statements and related Notes included in Item 1 of this quarterly report and the
Consolidated Financial Statements and related Notes and Managements Discussion and Analysis of
Financial Condition and Results of Operations contained in our Annual Report on Form 10-K as filed
with the Securities and Exchange Commission on March 16, 2006.
Overview
Dynavax Technologies Corporation (the Company) discovers, develops and intends to
commercialize innovative products to treat and prevent allergies, infectious diseases, cancer and
chronic inflammatory diseases using versatile, proprietary approaches that alter immune system
responses in highly specific ways. Our clinical development programs are based on immunostimulatory
sequences, or ISS, which are short DNA sequences designed to enhance the ability of the immune
system to fight disease and control chronic inflammation. Our most advanced ISS-based clinical
pipeline programs are a ragweed allergy immunotherapeutic and a hepatitis B vaccine.
Our clinical development pipeline currently includes: TOLAMBA, a ragweed allergy
immunotherapeutic, for which a major safety and efficacy trial is currently underway, and that is
in a supportive clinical trial in ragweed allergic children; HEPLISAV, a hepatitis B vaccine that
is currently in a Phase 3 clinical trial; SUPERVAX, a hepatitis B vaccine; a cancer therapy
currently in a Phase 2 clinical trial and anticipated to enter clinical trials in solid tumors; and
an asthma immunotherapeutic that has shown preliminary safety and pharmacology in a Phase 2a
clinical trial. We also have preclinical programs in hepatitis B therapy and hepatitis C therapy
that are funded by Symphony Dynamo, Inc. (SDI) and preclinical programs focused on chronic
inflammation, antiviral therapies and improved, next-generation vaccines using ISS and other
technologies.
Recent Developments
TOLAMBA
TOLAMBA (formerly, Amb a 1 ISS Conjugate or AIC) is a novel injectable product candidate to
treat ragweed allergy. In early 2006, we announced results from a two-year Phase 2/3 clinical trial
of TOLAMBA showing that patients treated with a single six-week course of TOLAMBA prior to the 2004
season experienced a statistically significant reduction in total nasal symptom scores and other
efficacy endpoints compared to placebo-treated patients in the second year of the trial. The safety
profile of TOLAMBA was favorable. Systemic side effects were indistinguishable from placebo and
local injection site tenderness was minor and transient.
Following a discussion with the U.S. Food & Drug Administration (FDA) in the first quarter
2006, we decided to conduct an additional major safety and efficacy trial with the goal of
determining whether a more intensive, single-course dosing regimen can elicit a greater treatment
effect than prior regimens. In the second quarter of 2006, we initiated the Dynavax Allergic
Rhinitis TOLAMBA Trial, or DARTT, and announced that enrollment in the DARTT exceeded expectations
relative to the speed and number of study subjects. DARTT is a two-year, multi-center,
well-controlled study in 738 ragweed allergic subjects, aged 18 to 55 years, randomized into three
arms: prior dosing regimen, higher total dose regimen, and placebo. Subjects receive six injections
over six weeks prior to the start of the 2006 ragweed season. Ragweed symptoms will be followed
over the 2006 and 2007 ragweed seasons. The primary endpoint is reduction in total nasal symptom
scores (TNSS) in the higher total dose arm compared to placebo during the second (2007) ragweed
season. The trial design includes an interim analysis to be conducted in early 2007 following
completion of the 2006 ragweed season. We anticipate that data from the DARTT interim analysis, if
positive, combined with the safety and efficacy data from the recently completed two year Phase 2/3
trial, and from an ongoing trial in ragweed allergic children, could provide sufficient patient
data for determining the potential timeline to registration.
16
HEPLISAV
HEPLISAV, our product candidate for hepatitis B prophylaxis, completed a Phase 2/3 trial
conducted in Singapore in adults (40 years of age and older) who are more difficult to immunize
with conventional vaccines. Results from the final analysis of this trial showed statistically
significant superiority in protective antibody response and robustness of protective effect after
three vaccinations when compared to GlaxoSmithKlines Engerix-B®. We intend to focus our
development activities and resources on maximizing the potential of HEPLISAVs demonstrated
superiority over conventional hepatitis B vaccine in both the younger (under 40 years of age) and
older adult populations, and its potential in the worldwide dialysis market.
The pivotal Phase 3 trial in the older, more difficult to immunize population in Asia and the
U.S.-based Phase 1 trial in patients with end-stage renal disease (pre-hemodialysis) are ongoing.
We are in the process of planning additional trials designed to support registration activities. In
the second half of 2006, we plan to initiate pivotal Phase 3 safety and efficacy trials for
HEPLISAV in the younger adult population in the U.S., Europe and Canada. Also in the second half of
2006, we anticipate initiating a Phase 2 trial in the dialysis population that would be conducted
in Europe and/or Canada.
SUPERVAX
In April 2006, we announced the acquisition of Rhein Biotech GmbH, which we refer to as
Dynavax Europe. As a result, we acquired a hepatitis B vaccine product called SUPERVAX that has
been tested in more than 600 subjects and has demonstrated safety and 99% seroprotection compared
to conventional vaccine when administered on a convenient, 0, 1-month two-dose schedule. We intend
to continue development of and registration activities for SUPERVAX as a two-dose vaccine for
commercialization in developing countries.
Symphony Dynamo, Inc.
In April 2006, we entered into a series of related agreements with Symphony Capital Partners,
LP to advance specific Dynavax ISS-based programs for cancer, hepatitis B therapy and hepatitis C
therapy through certain stages of clinical development. Pursuant to the agreements, Symphony
Dynamo, Inc. (SDI) has agreed to invest $50.0 million to fund the clinical development of these
programs and we have licensed to SDI our intellectual property rights related to these programs.
SDI is a wholly-owned subsidiary of Symphony Dynamo Holdings LLC (Holdings), which provided $20.0
million in funding to SDI at closing, and which is obligated to fund an additional $30.0 million in
one year following closing. We continue to be primarily responsible for the development of these
programs.
Pursuant to the agreements, we issued to Holdings a five-year warrant to purchase 2,000,000
shares of Dynavax common stock at $7.32 per share, representing a 25% premium over the recent
60-day trading range average of $5.86 per share. The warrant exercise price is subject to reduction
to $5.86 per share under certain circumstances. The warrant may be
exercised or surrendered for a cash payment upon consummation of an
all cash merger or acquisition of Dynavax, the obligation for which
would be settled by the surviving entity. In consideration for the warrant, Dynavax received
an exclusive purchase option (Purchase Option) to acquire all of the programs through the purchase
of all of the equity in Symphony Dynamo during the five-year term at specified prices. The Purchase
Option exercise price is payable in cash or a combination of cash and shares of Dynavax common
stock, at Dynavaxs sole discretion. Dynavax also has an option to purchase either the hepatitis B
or hepatitis C program (Program Option) during the first year of the agreement. The Program Option
is exercisable at our sole discretion at a price which is payable in cash only and will be fully
creditable against the exercise price for any subsequent exercise of the Purchase Option. If the
Company does not exercise its exclusive right to purchase some or all of the programs licensed
under the agreement, the intellectual property rights to the programs at the end of the development
period will remain with SDI.
In cancer, we believe that the potent and multifaceted biological activities of ISS offer a
number of distinct approaches to cancer therapy in a wide range of tumor types. We are evaluating
the potential of ISS to enhance the effect of monoclonal antibodies in cancer therapies. We have
conducted an open-label Phase I, dose-escalation trial of ISS in combination with Rituxan®
(rituximab) in 20 patients with non-Hodgkins lymphoma (NHL). Results of this study showed
dose-dependent pharmacological activity without significant toxicity. A follow-up Phase 2 trial of
ISS with Rituxan in NHL is currently underway in 30 patients with histologically confirmed CD20+,
B-cell follicular NHL who have received at least one previous treatment regimen for lymphoma. The
primary objective is to assess the proportion of patients who are alive and without disease
progression one year after initiating Rituxan therapy. Mechanistic studies will be performed to
characterize the enhancement of antitumor activity by ISS.
We anticipate that our cancer product candidate will advance into clinical trials in solid
tumors in 2006, and our hepatitis B and hepatitis C therapeutic product candidates are currently
planned to enter the clinic in 2007.
17
Critical Accounting Policies and the Use of Estimates
We believe that there have been no significant changes in its critical accounting policies
during the six months ended June 30, 2006 as compared with those disclosed in its Annual Report on
Form 10-K for the year ended December 31, 2005, except as discussed below.
Revenue Recognition
We recognize revenue from collaborative agreements, the performance of research and
development and contract manufacturing services, royalty and license fees and grants. We recognize
revenue when there is persuasive evidence that an arrangement exists, delivery has occurred or
services have been rendered, the price is fixed or determinable and collectibility is reasonably
assured.
Revenues from collaboration and research and development service agreements are recognized as
work is performed. Any amounts received in advance of performance are recorded as deferred revenue
and recognized as earned over the estimated term of the performance obligation. Revenue from
milestones with substantive performance risk is recognized upon achievement of the milestone. All
revenue recognized to date under these collaborations and milestones has been nonrefundable.
Revenues from the manufacturing and sale of vaccine and other materials at the Dynavax Europe facility
are recognized upon meeting the criteria for substantial performance and acceptance by the customer. Revenues from license fees and royalty payments are recognized when earned; up-front
nonrefundable fees where the Company has no continuing performance obligations are recognized as
revenues when collection is reasonably assured.
Grant revenue from government and private agency grants are recognized as the related research
expenses are incurred and to the extent that funding is approved. Additionally, we recognize
revenue based on the facilities and administrative cost rate reimbursable per the terms of the
grant awards. Any amounts received in advance of performance are recorded as deferred revenue until
earned.
Stock-Based Compensation
On January 1, 2006, the Company adopted the fair value recognition provisions of Statement of
Financial Accounting Standards 123R, Share-Based Payment (FAS 123R) using the
modified-prospective transition method. Under this transition method, compensation cost includes:
(a) compensation cost for all share-based payments granted prior to, but not yet vested as of
January 1, 2006, based on the grant date fair value estimated in accordance with the original
provisions of FAS 123 and (b) compensation cost for all share-based payments granted subsequent to
January 1, 2006, based on the grant date fair value estimated in accordance with the provisions of
FAS 123R. Results for prior periods have not been restated.
As
a result of the adoption of FAS 123R, the Company reduced its
deferred stock compensation balance and additional paid in capital by
$2.5 million as of January 1, 2006. As of June 30,
2006, the total unrecognized compensation cost related to non-vested
options granted amounted to $7.7 million, which is expected to
be recognized over the options remaining weighted-average vesting
period of 1.7 years.
Determining the appropriate fair value model and calculating the fair value of stock-based
awards at the grant date requires judgment, including estimating forfeiture rates, stock price
volatility and expected option life. The fair value of each option is amortized on a straight-line
basis over the options vesting period, assuming an annual forfeiture rate of 11%. The fair value
of each option is estimated on the date of grant using the Black-Scholes option valuation model,
which requires the input of highly subjective assumptions including the expected life of the option
and expected stock price volatility. The expected life of options granted is estimated based on
historical option exercise and employee termination data. Executive level employees, who hold a
majority of the options outstanding, were grouped and considered separately for valuation purposes,
which resulted in an expected life of 6.25 years. Non-executive level employees were found to have
similar historical option exercise and termination behavior resulting in an expected life of 4
years. Expected volatility is based on historical volatility of the Companys stock and comparable
peer data over the life of the options granted to executive and non-executive level employees.
Acquired In-process Research and Development
We allocate the purchase price of acquisitions based on the estimated fair
value of the assets
acquired and liabilities assumed. To assist in determining the value
of the acquired in-process research and development and certain
other intangibles associated with the Rhein Biotech GmbH transaction
discussed in Note 2 to the condensed consolidated financial
statements, we obtained a third party valuation as of the acquisition
date. We used the income approach and the cost approach to value
in-process research and development. The income approach is based on the premise
that the value of an asset is the present value of the future earning capacity that is available
for distribution to the investors in the asset. We perform a discounted cash flow analysis,
utilizing anticipated revenues, expenses and net cash flow forecasts related to the technology.
Given the high risk associated with the development of new drugs, we adjust the revenue and expense
forecasts to reflect the probability and risk of advancement
18
through the regulatory approval process based on the stage of development in the regulatory
process. Such a valuation requires significant estimates and assumptions. We believe the estimated
fair value assigned to the in-process research and development and other intangibles is based on
reasonable assumptions. However, these assumptions may be incomplete or inaccurate, and
unanticipated events and circumstances may occur. Additionally, estimates for the purchase price
allocation may change as subsequent information becomes available.
Goodwill and Other Intangible Assets
Goodwill amounts are recorded as the excess purchase price over tangible assets, liabilities
and intangible assets acquired based on their estimated fair value, by applying the purchase method
of accounting. The valuation in connection with the initial purchase price allocation and the
ongoing evaluation for impairment of goodwill and intangible assets requires significant management
estimates and judgment. The purchase price allocation process requires management estimates and
judgment as to expectations for various products and business strategies. If any of the significant
assumptions differ from the estimates and judgments used in the purchase price allocation, this
could result in different valuations for goodwill and intangible assets. We evaluate goodwill for
impairment on an annual basis and on an interim basis if events or changes in circumstances between
annual impairment tests indicate that the asset might be impaired as required by SFAS No. 142,
Goodwill and Other Intangible Assets.
Valuation of Long-lived Assets
Long-lived assets to be held and used, including property and equipment and identified
intangible assets, are reviewed for impairment in accordance with SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets whenever events or changes in circumstances indicate
that the carrying value of such assets may not be recoverable. Factors we consider important that
could indicate the need for an impairment review include the following:
|
|
|
significant changes in the strategy for our overall business; |
|
|
|
|
significant underperformance relative to expected historical or projected future operating results; |
|
|
|
|
significant changes in the manner of our use of acquired assets; |
|
|
|
|
significant negative industry or economic trends; |
|
|
|
|
significant decline in our stock price for a sustained period; and |
|
|
|
|
our market capitalization relative to net book value. |
Determination of recoverability is based on an estimate of undiscounted cash flows resulting
from the use of the asset and its eventual disposition. Measurement of impairment charges for
long-lived assets that management expects to hold and use are based on the fair value of such
assets.
Consolidation of Variable Interest Entities
Under FIN 46R, Consolidation of
Variable Interest Entities, arrangements that are not controlled through voting or similar rights are accounted for as
variable interest entities (VIEs). An enterprise is required to consolidate a VIE if it is the primary beneficiary of the VIE.
The enterprise that is deemed to absorb a majority of the expected losses or receive a majority of expected residual returns of
the VIE is considered the primary beneficiary.
Based on the provisions of FIN 46R,
we have concluded that under certain circumstances when we enter into agreements that contain an option to purchase assets
or equity securities from an entity, or enter into an arrangement with a financial partner for the formation of joint
ventures which engage in research and development projects, a VIE may be created. For each VIE created, we compute expected
losses and residual returns based on the probability of future cash flows. If we are determined to be the primary beneficiary
of the VIE, the assets, liabilities and operations of the VIE will be consolidated with our financial statements. Our
consolidated financial statements include the accounts of Symphony Dynamo, Inc. discussed in Note 4.
Results of Operations
Revenues
The following is a summary of our revenues (in thousands, except percentages):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Increase (Decrease) |
|
|
Six Months Ended |
|
|
Increase (Decrease) |
|
|
|
June 30, |
|
|
from 2006 to 2005 |
|
|
June 30, |
|
|
from 2006 to 2005 |
|
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
% |
|
$ |
|
|
|
$ |
12,199 |
|
|
$ |
(12,199 |
) |
|
|
(100 |
)% |
Services and license
revenue |
|
|
224 |
|
|
|
|
|
|
|
224 |
|
|
|
100 |
% |
|
|
224 |
|
|
|
|
|
|
|
224 |
|
|
|
100 |
% |
Grant revenue |
|
|
305 |
|
|
|
953 |
|
|
|
(648 |
) |
|
|
(68 |
)% |
|
|
593 |
|
|
|
1,452 |
|
|
|
(859 |
) |
|
|
(59 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
529 |
|
|
$ |
953 |
|
|
$ |
(424 |
) |
|
|
(44 |
)% |
|
$ |
817 |
|
|
$ |
13,651 |
|
|
$ |
(12,834 |
) |
|
|
(94 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues for the six months ended June 30, 2006 were $0.8 million, compared to $13.7
million for the same period in 2005. Total revenues in the second quarter 2006 consisted of
services and license fees from Dynavax Europe for the first time and grants awarded by the National
Institute of Allergy and Infectious Diseases and by the Alliance for Lupus Research. Collaboration
revenue for the six months ended June 30, 2005 included accelerated recognition of $7.0 million in
deferred revenue following the end of our collaboration with UCB in March 2005. Our ability to
generate future collaboration revenue in 2006 and beyond will be dependent on our ability to enter
into new collaborative relationships. Until we enter into new collaboration arrangements, we expect
our future
19
revenues will be limited to grants and services and license revenue from Dynavax Europe.
Research and Development
Research and development expense consists primarily of outside services related to our
preclinical experiments and clinical trials, regulatory filings, manufacturing our product
candidates for our preclinical experiments and clinical trials; compensation and related personnel
costs which include benefits, recruitment, travel and supply costs; allocated facility costs and
non-cash stock-based compensation. We expense our research and development costs as they are
incurred.
The following is a summary of our research and development expense (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Increase (Decrease) |
|
|
Six Months Ended |
|
|
Increase (Decrease) |
|
|
|
June 30, |
|
|
from 2006 to 2005 |
|
|
June 30, |
|
|
from 2006 to 2005 |
|
Research and development: |
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Compensation and
related personnel costs |
|
$ |
3,069 |
|
|
$ |
2,131 |
|
|
$ |
938 |
|
|
|
44 |
% |
|
$ |
5,544 |
|
|
$ |
4,284 |
|
|
$ |
1,260 |
|
|
|
29 |
% |
Outside services |
|
|
6,180 |
|
|
|
4,334 |
|
|
|
1,846 |
|
|
|
43 |
% |
|
|
9,046 |
|
|
|
6,826 |
|
|
|
2,220 |
|
|
|
33 |
% |
Facility costs |
|
|
1,241 |
|
|
|
885 |
|
|
|
356 |
|
|
|
40 |
% |
|
|
2,208 |
|
|
|
1,756 |
|
|
|
452 |
|
|
|
26 |
% |
Non-cash stock-based
compensation |
|
|
272 |
|
|
|
143 |
|
|
|
129 |
|
|
|
90 |
% |
|
|
556 |
|
|
|
282 |
|
|
|
274 |
|
|
|
97 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and
development |
|
$ |
10,762 |
|
|
$ |
7,493 |
|
|
$ |
3,269 |
|
|
|
44 |
% |
|
$ |
17,354 |
|
|
$ |
13,148 |
|
|
$ |
4,206 |
|
|
|
32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses of $17.4 million for the six months ended June 30, 2006
increased by $4.2 million, or 32%, from the same period in 2005. The increase over the prior year
was primarily due to increased clinical trial and clinical manufacturing activities related to our
lead product candidates TOLAMBA and HEPLISAV, $1.4 million related to Dynavax Europe operations,
and programs funded by SDI. Compensation and related personnel costs also increased in 2006
attributed to continued organizational growth to support further development of our clinical
candidates. We incurred additional stock-based compensation charges resulting from our adoption of
FAS 123R effective January 1, 2006.
We anticipate that our research and development expenses will increase significantly during
2006 primarily in connection with the advancement of our clinical development programs in the areas
of allergy and hepatitis B, as well as additional expenses associated with Dynavax Europe and SDI.
General and Administrative
General and administrative expense consists primarily of compensation and related personnel
costs, outside services such as accounting, consulting, business development, investor relations
and insurance, legal and patent costs, allocated facility costs and non-cash stock-based
compensation.
The following is a summary of our general and administrative expense (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Increase (Decrease) |
|
|
Six Months Ended |
|
|
Increase (Decrease) |
|
|
|
June 30, |
|
|
from 2006 to 2005 |
|
|
June 30, |
|
|
From 2006 to 2005 |
|
General and administrative: |
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Compensation and related
personnel costs |
|
$ |
1,641 |
|
|
$ |
1,095 |
|
|
$ |
546 |
|
|
|
50 |
% |
|
$ |
2,805 |
|
|
$ |
2,188 |
|
|
$ |
617 |
|
|
|
28 |
% |
Outside services |
|
|
784 |
|
|
|
720 |
|
|
|
64 |
|
|
|
9 |
% |
|
|
1,464 |
|
|
|
1,329 |
|
|
|
135 |
|
|
|
10 |
% |
Legal and patent costs, net |
|
|
348 |
|
|
|
342 |
|
|
|
6 |
|
|
|
2 |
% |
|
|
632 |
|
|
|
677 |
|
|
|
(45 |
) |
|
|
(7 |
)% |
Facility costs |
|
|
149 |
|
|
|
122 |
|
|
|
27 |
|
|
|
21 |
% |
|
|
293 |
|
|
|
248 |
|
|
|
45 |
|
|
|
17 |
% |
Gain on disposal of property and
equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% |
|
|
(50 |
) |
|
|
|
|
|
|
(50 |
) |
|
|
(100 |
)% |
Non-cash stock-based compensation |
|
|
458 |
|
|
|
193 |
|
|
|
265 |
|
|
|
138 |
% |
|
|
839 |
|
|
|
371 |
|
|
|
468 |
|
|
|
126 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total general and administrative |
|
$ |
3,380 |
|
|
$ |
2,473 |
|
|
$ |
908 |
|
|
|
37 |
% |
|
$ |
5,983 |
|
|
$ |
4,813 |
|
|
$ |
1,170 |
|
|
|
24 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses of $6.0 million for the six months ended June 30, 2006
increased by $1.2 million, or 24%, from the same period in 2005. The increase over the prior year
primarily reflects the additional compensation and related personnel
20
costs associated with overall organizational growth, including the impact of Dynavax Europe
operations which accounted for approximately $0.4 million of the increase in general and
administrative expenses. In addition, we incurred higher stock-based compensation charges resulting
from our adoption of FAS 123R effective January 1, 2006.
We expect general and administrative expenses to increase during 2006, resulting from
continued organizational growth and expenses incurred to support the advancement of our clinical
development programs as well as additional expenses associated with Dynavax Europe, SDI and
preparation for integration and compliance of those operations with our public reporting
obligations.
Acquired In-process Research and Development
Following our acquisition of Dynavax Europe in April 2006, we recorded the assets acquired and
liabilities assumed based on their estimated fair values at the date of acquisition. As a result,
we recorded net tangible assets of $3.0 million, goodwill and other intangible assets of $7.4
million, and expense associated with the acquired in-process research and development of $4.2
million, representing the fair value of research projects that had not yet reached technological
feasibility and that have no alternative future use.
Amortization of Intangible Assets
Intangible assets resulting from our acquisition of Dynavax Europe consist primarily of
manufacturing process, customer relationships, and developed technology. Amortization of intangible assets
was $0.2 million for the three and six months ended June 30, 2006.
Interest and Other Income, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Increase (Decrease) |
|
|
Six Months Ended |
|
|
Increase (Decrease) |
|
|
|
June 30, |
|
|
from 2006 to 2005 |
|
|
June 30, |
|
|
from 2006 to 2005 |
|
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
|
2006 |
|
|
2005 |
|
|
$ |
|
|
% |
|
Interest and other income, net |
|
$ |
685 |
|
|
$ |
434 |
|
|
$ |
251 |
|
|
|
58 |
% |
|
$ |
1,420 |
|
|
$ |
801 |
|
|
$ |
619 |
|
|
|
77 |
% |
Interest and other income, net is comprised of interest income; amortization on marketable
securities; and realized gains and losses on investments, disposals of property and equipment and
foreign currency translation. Interest and other income, net of $1.4 million for the six months
ended June 30, 2006 compared to $0.8 million reported for the same period in 2005. The increase was
primarily due to the investment of proceeds from our follow-on equity offering in the fourth
quarter of 2005, as well as interest earned on the investments held by SDI.
Non-controlling Interest in Symphony Dynamo, Inc.
Pursuant to the agreements that we entered into with SDI in April 2006, the results of operations of SDI have been included in our condensed consolidated financial
statements from the date of formation. Reimbursable expenses related
to the SDI programs were $2.0 million for the period from
April 18, 2006 through June 30, 2006, as reflected in the
loss attributed to the noncontrolling interest in SDI.
Liquidity and Capital Resources
We have financed our operations since inception primarily through the sale of shares of our
common stock, shares of our convertible preferred stock, and ordinary shares in a subsidiary, which
have yielded a total of approximately $177.9 million in net cash proceeds and, to a lesser extent,
through amounts received under collaborative agreements and government grants for biodefense
programs. We have also financed certain of our research and development activities under our
agreements with SDI. We completed an initial public offering in February 2004, raising net proceeds
during fiscal 2004 of approximately $46.5 million from the sale of 6,900,000 shares of common
stock. In the fourth quarter of 2005, we completed an underwritten public offering that resulted in
net proceeds to the Company of approximately $33.1 million from the sale of 5,720,000 shares of our
common stock. As of June 30, 2006, we had $41.7 million in cash, cash equivalents and marketable
securities and $19.0 million in investments held by SDI. Our funds are currently invested in a
variety of securities, including highly liquid institutional money market funds, commercial paper,
government and non-government debt securities and corporate obligations.
Cash used in operating activities of $17.9 million during the six months ended June 30, 2006
compared to $6.7 million for the same period in 2005. The increase in cash usage over the prior
year was due primarily to the increase in our net loss from operations and the increase in working
capital. Cash provided by investing activities of $1.6 million during the six months ended June 30,
2006
21
compared to usage of cash of $4.9 million for the same period in 2005. The increase was
attributed to sales of marketable securities, net of $14.0 million in cash paid to acquire Dynavax
Europe and $19.0 million in purchases of investments held by SDI. Cash provided by financing
activities was $17.6 million during the six months ended June 30, 2006 compared to $0.2 million for
the same period in 2005, resulting primarily from proceeds from investments in SDI.
Excluding the potential impact of any equity offerings, business collaborations or other
transactions that may be entered into, we expect our cash and cash equivalents, marketable
securities and investments held by SDI to decline by December 31, 2006, primarily due to cash used
for operations. We expect net cash used in operating activities to increase significantly in 2006
as compared to prior years related to the advancement of our clinical development programs.
We currently anticipate that our cash and cash equivalents, marketable securities, and
investments in and expected to be made by SDI will enable us to maintain our operations for at
least the next twelve months. Because of the significant time it will take for any of our product
candidates to complete the clinical trials process, be approved by regulatory authorities and
successfully commercialized, we may require substantial additional capital resources. We may raise
additional funds through public or private equity offerings, debt financings, capital lease
transactions, corporate collaborations or other means. We may attempt to raise additional capital
due to favorable market conditions or strategic considerations even if we have sufficient funds for
planned operations.
Additional financing may not be available on acceptable terms, if at all. Capital may become
difficult or impossible to obtain due to poor market or other conditions that are outside of our
control. If at any time sufficient capital is not available, either through existing capital
resources or through raising additional funds, we may be required to delay, scale back or eliminate
some or all of our research or development programs, to lose rights under existing licenses or to
relinquish greater or all rights to product candidates at an earlier stage of development or on
less favorable terms than we would otherwise choose or may adversely affect our ability to operate
as a going concern.
Contractual Obligations
The following summarizes our significant contractual obligations as of June 30, 2006 and the
effect those obligations are expected to have on our liquidity and cash flow in future periods (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
Contractual Obligations: |
|
Total |
|
|
Less than 1 Year |
|
|
1-3 Years |
|
|
4-5 Years |
|
Future minimum payments under our operating lease |
|
$ |
6,869 |
|
|
$ |
1,051 |
|
|
$ |
4,331 |
|
|
$ |
1,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
6,869 |
|
|
$ |
1,051 |
|
|
$ |
4,331 |
|
|
$ |
1,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We lease our facilities in Berkeley, California and Düsseldorf, Germany under operating
leases that expire in September 2014 (Berkeley Lease) and August 2009 (Düsseldorf Lease),
respectively. The Berkeley Lease can be terminated at no cost to the Company in September 2009 but
otherwise extends automatically until September 2014. We have entered into a sublease agreement
under the Berkeley Lease for a certain portion of the leased space with scheduled payments to us
totaling $0.4 million annually through 2007. This sublease agreement includes an option for early
termination by the Company in August 2006 but otherwise extends automatically until August 2007.
During the fourth quarter of 2004, we established a letter of credit with Silicon Valley Bank as
security for our Berkeley Lease in
the amount of $0.4 million. The letter of credit remained outstanding as of June 30, 2006 and is
collateralized by a certificate of deposit which has been included in restricted cash in the
consolidated balance sheets as of June 30, 2006 and December 31, 2005. Under the terms of the
Berkeley Lease, if the total amount of our cash, cash equivalents and marketable securities falls
below $20.0 million for a period of more than 30 consecutive days during the lease term, the amount
of the required security deposit will increase to $1.1 million, until such time as our projected
cash and cash equivalents will exceed $20.0 million for the remainder of the lease term, or until
our actual cash and cash equivalents remains above $20.0 million for a period of 12 consecutive
months.
In addition to the non-cancelable commitments included above, we have entered into contractual
arrangements that obligate us to make payments to the contractual counterparties upon the
occurrence of future events. In the normal course of operations, we have entered into license and
other agreements and intend to continue to seek additional rights relating to compounds or
technologies in connection with our discovery, manufacturing and development programs. Under the
terms of the agreements, the Company may be required to pay future up-front fees, milestones and
royalties on net sales of products originating from the licensed technologies. We consider these
potential obligations to be contingent and have summarized all significant arrangements below.
22
We rely on research institutions, contract research organizations (CRO), clinical
investigators and clinical manufacturers. As of June 30, 2006, under the terms of our agreements,
we are obligated to make future payments as services are provided of approximately $33 million
through 2008. These agreements are terminable by us upon written notice. We are generally only
liable for actual effort expended by the organizations at any point in time during the contract,
subject to certain termination fees and penalties.
We entered into a series of exclusive license agreements with the Regents of the University of
California in March 1997 and October 1998. These agreements provide us with certain technology and
related patent rights and materials related to ISS, TNF-alpha inhibitors, vaccines using DNA and
immunoregulatory sequences. Under the terms of the agreements, we pay annual license or maintenance
fees and will be required to pay milestones and royalties on net sales of products originating from
the licensed technologies.
On April 21, 2006, Rhein and Green Cross Vaccine
Corp. entered into an exclusive license agreement whereby Green Cross granted Rhein an exclusive
license relating to a hepatitis B vaccine. In exchange, Rhein will be required to pay Green Cross a
certain profit share until Green Crosss development costs for the product are recouped and a
certain profit share for a specified period of time after the hepatitis B product is launched in
Europe and Asia.
In December 2004, Rhein entered into a joint venture agreement under which it is obligated to
perform research and development services up to a maximum of 1.5 million Euro, or approximately
$2.0 million, related to the development of a vaccine for cytomegalovirus. As of June 30, 2006, the
remaining obligation was approximately $1.0 million.
23
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The primary objective of our investment activities is to preserve principal while at the same
time maximize the income we receive from our investments without significantly increasing risk.
Some of the securities that we invest in may have market risk. This means that a change in
prevailing interest rates may cause the principal amount of the investment to fluctuate. To
minimize this risk, we maintain our portfolio of cash equivalents and investments in a variety of
securities, including commercial paper, money market funds, government and non-government debt
securities and corporate obligations. Because of the short-term maturities of our cash equivalents
and marketable securities, we do not believe that an increase in market rates would have any
significant negative impact on the realized value of our investments.
Interest Rate Risk. We do not use derivative financial instruments in our investment
portfolio. Due to the short duration and conservative nature of our cash equivalents and marketable
securities, we do not expect any material loss with respect to our investment portfolio.
Foreign Currency Risk. We have certain investments outside the U.S. for the operations of
Dynavax Europe and have minimal exposure to foreign exchange rate fluctuations.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures
The Companys management, under the supervision and with the participation of the Companys
Chief Executive Officer (CEO) and Chief Financial Officer (CFO), performed an evaluation of the
effectiveness of the design and operation of the Companys disclosure controls and procedures as of
the end of the period covered by this report. Based on that evaluation, the CEO and CFO concluded
that the Companys disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934 (the Exchange Act)) as of the end of period covered by
this report have been designed and are functioning effectively to provide reasonable assurance that
the information required to be disclosed by us in reports filed under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in SEC rules and forms. We
believe that a control system, no matter how well designed and operated, cannot provide absolute
assurance that the objectives of the control system are met, and no evaluation of controls can
provide absolute assurance that all control issues and instances of fraud, if any, within a company
have been detected.
(b) Changes in internal controls
Since our acquisition of Dynavax Europe, we have expanded our internal control over financial
reporting to include consolidation of Dynavax Europes results of operations, as well as
acquisition-related accounting and disclosures. No other changes in the Companys internal control
over financial reporting occurred during the Companys last fiscal quarter that have materially
affected, or are reasonably likely to materially affect, the Companys internal control over
financial reporting.
24
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS.
Various statements in this Quarterly Report on Form 10-Q are forward-looking statements
concerning our future products, expenses, revenues, liquidity and cash needs, as well as our plans
and strategies. These forward-looking statements are based on current expectations and we assume no
obligation to update this information. Numerous factors could cause our actual results to differ
significantly from the results described in these forward-looking statements, including the
following risk factors.
We have incurred substantial losses since inception and do not have any commercial products that
generate revenue.
We have experienced significant operating losses in each year since our inception in August
1996. To date, our revenue has resulted from a collaboration agreement with UCB Farchim, S.A.
(UCB), services and license fees from Dynavax Europe, and government and private agency grants. The
UCB collaboration agreement ended in March 2005. The grants are subject to annual review based on
the achievement of milestones and other factors and will terminate in January 2007 at the latest.
Our accumulated deficit was $139.3 million as of June 30, 2006, and we anticipate that we will
incur substantial additional operating losses for the foreseeable future. These losses have been,
and will continue to be, principally the result of the various costs associated with our research
and development activities. We expect our losses to increase primarily as a consequence of our
continuing product development efforts.
We do not have any products that generate revenue. In April 2006, we initiated the Dynavax
Allergic Rhinitis TOLAMBA Trial, or DARTT, which is designed to complement data derived from the
recently completed Phase 2/3 clinical trial and our ongoing trial in ragweed allergic children. The
HEPLISAV pivotal Phase 3 trial in Asia and the U.S.-based Phase 1 trial in patients with
pre-hemodialysis are ongoing. These and our other product candidates may never be commercialized,
and we may never generate product-related revenue. Our ability to generate product revenue depends
upon:
|
|
|
demonstrating in clinical trials that our product candidates are safe and
effective, in particular, in the current and planned trials for TOLAMBA and HEPLISAV; |
|
|
|
|
obtaining regulatory approvals for our product candidates; |
|
|
|
|
entering into collaborative relationships on commercially reasonable terms for
the development, manufacturing, sales and marketing of our product candidates, and then
successfully managing these relationships; and |
|
|
|
|
obtaining commercial acceptance of our products, in particular TOLAMBA and
HEPLISAV. |
If we are unable to generate revenues or achieve profitability, we may be required to
significantly reduce or discontinue our operations or raise additional capital under adverse
circumstances.
If we are unable to secure additional funding, we will have to reduce or discontinue operations.
We believe our existing capital resources will be adequate to satisfy our capital needs for at
least the next twelve months. Because of the significant time and resources it will take to develop
our product candidates, potentially commercialize them and generate revenues, we will require
substantial additional capital resources in order to continue our operations, and any such funding
may not allow us to continue operations as currently planned. We expect capital outlays and
operating expenditures to increase over the next several years as we expand our operations, and any
change in plans may increase these outlays and expenditures. We may be unable to obtain additional
capital from financing sources or from agreements with collaborators on acceptable terms, or at
all. If at any time sufficient capital is not available, we may be required to delay, reduce the
scope of, or eliminate some or all of our research, preclinical or clinical programs or discontinue
our operations.
25
All of our product candidates are unproven, and our success depends on our product candidates being
approved through uncertain and time-consuming regulatory processes. Failure to prove our products
safe and effective in clinical trials and obtain regulatory approvals could require us to
discontinue operations.
None of our product candidates has been approved for sale. Any product candidate we develop is
subject to extensive regulation by federal, state and local governmental authorities in the United
States, including the FDA, and by foreign regulatory agencies. Our success is primarily dependent
on our ability to obtain regulatory approval for TOLAMBA, our ragweed allergy product candidate,
and HEPLISAV, our hepatitis B vaccine product candidate. Approval processes in the United States
and in other countries are uncertain, take many years and require the expenditure of substantial
resources. Product development failure can occur at any stage of clinical trials and as a result of
many factors, many of which are not under our control.
We will need to demonstrate in clinical trials that a product candidate is safe and effective
before we can obtain the necessary approvals from the FDA and foreign regulatory agencies. In early
2006, we announced results from a two-year Phase 2/3 clinical trial of TOLAMBA in which the safety
profile was favorable. In April 2006, we initiated the DARTT study, which broadens the TOLAMBA
clinical program and is designed to complement data derived from the recently completed Phase 2/3
clinical trial and our ongoing trial in ragweed allergic children initiated in 2005. If we identify
any safety issues associated with TOLAMBA, we may be restricted from initiating further trials for
TOLAMBA. Moreover, we may not see sufficient signs of efficacy in those studies. We have initiated
a pivotal Phase 3 trial for HEPLISAV in Asia. We are in the process of planning additional trials
designed to support registration activities. The FDA or foreign regulatory agencies may require us
to conduct additional clinical trials prior to approval in their jurisdictions.
Many new drug candidates, including many drug candidates that have completed Phase 3 clinical
trials, have shown promising results in early clinical trials and subsequently failed to establish
sufficient safety and efficacy to obtain regulatory approval. Despite the time and money expended,
regulatory approvals are uncertain. Failure to successfully complete clinical trials and show that
our products are safe and effective would have a material adverse effect on our ability to
eventually generate revenues and could require us to reduce the scope of or discontinue our
operations.
Our clinical trials may be extended, suspended, delayed or terminated at any time. Even short
delays in the commencement and progress of our trials may lead to substantial delays in the
regulatory approval process for our product candidates, which will impair our ability to generate
revenues.
We may extend, suspend or terminate clinical trials at any time for various reasons, including
regulatory actions by the FDA or foreign regulatory agencies, actions by institutional review
boards, failure to comply with good clinical practice requirements, concerns regarding health risks
to test subjects or inadequate supply of the product candidate. In addition, our ability to conduct
clinical trials for some of our product candidates, notably TOLAMBA, is limited due to the seasonal
nature of ragweed allergy. Even a small delay in a trial for any product candidate could require us
to delay commencement of the trial until the target population is available for testing, which
could result in a delay of an entire year. Our registration and commercial timelines will depend on
results of the current and planned clinical trials and further discussions with the FDA.
Consequently, we may experience additional delays in obtaining regulatory approval for these
product candidates.
In particular for TOLAMBA or HEPLISAV, any extension, suspension, termination or unanticipated
delays of our clinical trials could:
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adversely affect our ability to timely and successfully commercialize or market these product candidates; |
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result in significant additional costs; |
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potentially diminish any competitive advantages for those products; |
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adversely affect our ability to enter into collaborations, receive milestone
payments or royalties from potential collaborators; |
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cause us to abandon the development of the affected product candidate; or |
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limit our ability to obtain additional financing on acceptable terms, if at all. |
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If third parties successfully assert that we have infringed their patents and proprietary rights or
challenge the validity of our patents and proprietary rights, we may become involved in
intellectual property disputes and litigation that would be costly, time consuming, and delay or
prevent development or commercialization of our product candidates.
We may be exposed to future litigation by third parties based on claims that our product
candidates, proprietary technologies or the licenses on which we rely, infringe their intellectual
property rights, or we may be required to enter into litigation to enforce patents issued or
licensed to us or to determine the scope or validity of our or another partys proprietary rights,
including a challenge as to the validity of our issued and pending claims. If we become involved in
any litigation, interference or other administrative proceedings related to our intellectual
property or the intellectual property of others, we will incur substantial additional expenses and
it will divert the efforts of our technical and management personnel.
Two of our potential competitors relative to HEPLISAV, Merck & Co., Inc., or Merck, and
GlaxoSmithKline Plc, or GSK, are exclusive licensees of broad patents covering hepatitis B surface
antigen. In addition, the Institute Pasteur also owns or has exclusive licenses to patents covering
hepatitis B surface antigen. While some of these patents have expired or will soon expire outside
of the United States, they remain in force in the United States and are likely to be in force when
we commercialize HEPLISAV or a similar product in the United States. To the extent we were to
commercialize HEPLISAV in the United States, Merck and/or GSK or the Institute Pasteur may bring
claims against us.
If we are unsuccessful in defending or prosecuting our issued and pending claims or in
defending potential claims against us, for example, as may arise to the extent we were to
commercialize HEPLISAV or any similar product candidate in the United States, we could be required
to pay substantial damages and we may be unable to commercialize our product candidates or use our
proprietary technologies unless we obtain a license from these or other third parties. A license
may require us to pay substantial royalties, require us to grant a cross-license to our technology
or may not be available to us on acceptable terms or on any terms. In addition, we may be required
to redesign our technology so it does not infringe a third partys patents, which may not be
possible or could require substantial funds and time. Any of these outcomes may require us to
change our business strategy and could reduce the value of our business.
Another of our potential competitors, Coley Pharmaceutical Group, or Coley, has issued U.S.
patent claims, as well as patent claims pending with the U.S. Patent and Trademark Office, or PTO.
If these claims are held to be valid, Coley may seek to enforce its rights under these claims,
including, for example, by suing us for patent infringement. Consequently, we may need to obtain a
license to one or more of these claims held by Coley by paying cash, granting royalties on sales of
our products or offering rights to our own proprietary technologies in order to commercialize one
or more of our formulations of ISS in the U.S., including TOLAMBA and HEPLISAV. Such a license may
not be available to us on acceptable terms, if at all, which could preclude or limit out ability to
commercialize products.
In December 2003, the PTO declared an interference to resolve first-to-invent disputes between
a patent application filed by the Regents of the University of California, which is exclusively
licensed to us, and an issued U.S. patent owned by Coley relating to immunostimulatory DNA
sequences. The declaration of interference named the Regents of the University of California as
senior party, indicating that a patent application filed by the Regents of the University of
California and licensed to us was filed prior to a patent application owned by Coley that led to an
issued U.S. patent. The interference provides the first forum to challenge the validity and
priority of certain of Coleys patents. On March 10, 2005, the PTO issued a decision in the
interference which did not address the merits of the case, but dismissed it on technical legal
grounds based on the timing of Dynavaxs filing of its claims and request for interference. Dynavax
appealed this decision to the U.S. Federal Circuit court which on July 17, 2006, upheld the
decision of the PTO. Dynavax plans to file a motion for reconsideration and rehearing en banc.
If we receive regulatory approval for our product candidates, we will be subject to ongoing FDA and
foreign regulatory obligations and continued regulatory review, which may be costly and subject us
to various enforcement actions.
Any regulatory approvals that we receive for our product candidates are likely to contain
requirements for post-marketing follow-up studies, which may be costly. Product approvals, once
granted, may be modified, resulting in limitations on our labeling indications or marketing claims,
or withdrawn completely if problems occur after commercialization. Thus, even if we receive FDA and
other regulatory approvals, our product candidates may later exhibit qualities that limit or
prevent their widespread use or that force us to withdraw those products from the market.
In addition, we or our contract manufacturers will be required to adhere to federal
regulations setting forth current good manufacturing practice. The regulations require that our
product candidates be manufactured and our records maintained in a
27
prescribed manner with respect to manufacturing, testing and quality control activities.
Furthermore, we or our contract manufacturers must pass a pre-approval inspection of manufacturing
facilities by the FDA and foreign regulatory agencies before obtaining marketing approval and will
be subject to periodic inspection by the FDA and corresponding foreign regulatory agencies under
reciprocal agreements with the FDA. Further, to the extent that we contract with third parties for
the manufacture of our products, our ability to control third-party compliance with FDA
requirements will be limited to contractual remedies and rights of inspection.
Failure to comply with regulatory requirements could prevent or delay marketing approval or
require the expenditure of money or other resources to correct. Failure to comply with applicable
requirements may also result in warning letters, fines, injunctions, civil penalties, recall or
seizure of products, total or partial suspension of production, refusal of the government to renew
marketing applications and criminal prosecution, any of which could be harmful to our ability to
generate revenues and our stock price.
Our product candidates in clinical trials rely on a single lead ISS compound, 1018 ISS, and most of
our earlier stage programs rely on ISS-based technology. Serious adverse safety data relating to
either 1018 ISS or other ISS-based technology may require us to reduce the scope of or discontinue
our operations.
Our product candidates in clinical trials are based on our 1018 ISS compound, and
substantially all of our research and development programs use ISS-based technology. If any of our
product candidates in clinical trials produce serious adverse safety data, we may be required to
delay or discontinue all of our clinical trials. In addition, as all of our clinical product
candidates contain 1018 ISS, a common safety risk across therapeutic areas may hinder our ability
to enter into potential collaborations and if adverse safety data are found to apply to our
ISS-based technology as a whole, we may be required to significantly reduce or discontinue our
operations.
We have licensed some of our development and commercialization rights to certain of our development
programs in connection with the Symphony Dynamo funding arrangement and will not receive any future
royalties or revenues with respect to this intellectual property unless we exercise an option to
repurchase the programs in the future. We may not obtain sufficient clinical data in order to
determine whether we should exercise this option prior to the expiration of the development period,
and even if we decide to exercise, we may not have the financial resources to exercise this option
in a timely manner.
We have granted an exclusive license to the intellectual property for certain ISS compounds
for cancer, hepatitis B and hepatitis C therapeutics to Symphony Dynamo, Inc., or SDI, in
consideration for a commitment from Symphony Capital Partners, LP and its co-investors to provide
$50 million of committed capital to advance these programs. The funding is to be provided in two
tranches, $30 million of which remains to be provided by the first anniversary of the agreement. As
part of the arrangement, we received an option granting us the exclusive right, but not the
obligation, to acquire certain or all of the programs at specified points in time at specified
prices during the term of the five-year development period. The development programs under the
arrangement will be jointly managed by SDI and us, and there can be no assurance that we will agree
on various decisions that will enable us to successfully develop the potential products, or even if
we are in agreement on the development plans, that the development efforts will result in
sufficient clinical data to make a fully informed decision with respect to the exercise of our
option. If we do not exercise the purchase option prior to its expiration, then our rights in and
with respect to the SDI programs will terminate and we will no longer have rights to any of the
programs licensed to SDI under the arrangement.
If we elect to exercise the purchase option, we will be required to make a substantial
payment, which at our election may be paid partially in shares of our common stock. As a result, in
order to exercise the option, we will be required to make a substantial payment of cash and
possibly issue a substantial number of shares of our common stock. We do not currently have the
resources to exercise the option and we may be required to enter into a financing arrangement or
license arrangement with one or more third parties, or some combination of these in order to
exercise the option, even if we paid a portion of the purchase price with our common stock. There
can be no assurance that any financing or licensing arrangement will be available or even if
available, that the terms would be favorable to us and our stockholders. In addition, the exercise
of the purchase option will likely require us to record a significant charge to earnings and may
adversely impact future operating results.
A key part of our business strategy is to establish collaborative relationships to commercialize
and fund development of our product candidates. We may be unsuccessful in establishing and managing
collaborative relationships, which may significantly limit our ability to develop and commercialize
our products successfully, if at all.
We will need to establish collaborative relationships to obtain domestic and international
sales, marketing and distribution capabilities for our product candidates. We also intend to enter
into collaborative relationships to provide funding to support our
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research and development programs. Our collaboration agreement with UCB for TOLAMBA and for
grass allergy immunotherapy ended in March 2005. Future collaboration revenue will depend on our
ability to enter into new collaborative relationships.
The process of establishing collaborative relationships is difficult, time-consuming and
involves significant uncertainty. Moreover, even if we do establish collaborative relationships,
our collaborators may seek to renegotiate or terminate their relationships with us due to
unsatisfactory clinical results, a change in business strategy, a change of control or other
reasons. If any collaborator fails to fulfill its responsibilities in a timely manner, or at all,
our research, clinical development or commercialization efforts related to that collaboration could
be delayed or terminated, or it may be necessary for us to assume responsibility for expenses or
activities that would otherwise have been the responsibility of our collaborator. If we are unable
to establish and maintain collaborative relationships on acceptable terms, we may have to delay or
discontinue further development of one or more of our product candidates, undertake development and
commercialization activities at our own expense or find alternative sources of capital.
We rely on third parties to supply materials and perform functions necessary to manufacture our
clinical product candidates for our clinical trials. Loss of these suppliers or manufacturers, or
failure to replace them may delay our clinical trials and research and development efforts and may
result in additional costs, which would preclude us from producing our product candidates on
commercially reasonable terms.
We rely on a number of third parties for the multiple steps involved in the manufacturing
process of our product candidates, including, for example, the manufacture of the antigens and ISS,
the component materials that are necessary for our product candidates, the combination of the
antigens and ISS, and the fill and finish. Termination or interruption of these relationships may
occur due to circumstances that are outside our control, resulting in higher cost or delays in our
product development efforts.
We and these third parties are required to comply with applicable current FDA good
manufacturing practice regulations and similar requirements in Canada and other foreign countries.
If one of these parties fails to maintain compliance with these regulations, the production of our
product candidates could be interrupted, resulting in delays and additional costs. Additionally,
these third parties must pass a pre-approval inspection before we can obtain regulatory approval
for any of our product candidates.
In particular, we have relied on a single supplier to produce our ISS for clinical trials. ISS
is a critical component of both of TOLAMBA and HEPLISAV. To date, we have manufactured only small
quantities of ISS ourselves for research purposes. If we were unable to maintain or replace our
existing source for ISS, we would have to establish an in-house ISS manufacturing capability,
incurring increased capital and operating costs and delays in developing and commercializing our
product candidates. We or other third parties may not be able to produce ISS at a cost, quantity
and quality that are available from our current third-party supplier.
In addition, we do not currently have a contract manufacturer for TOLAMBA or sufficient
TOLAMBA to supply our potential commercial needs. We are currently manufacturing supplies of
TOLAMBA for the second year of our current clinical trial in ragweed allergic children. We intend
to enter into manufacturing agreements with one or more commercial-scale contract manufacturers to
produce additional supplies of TOLAMBA as required for new clinical trials and commercialization.
If we are unable to complete such agreements, we may be unable to commence and complete our
clinical trials in a timely fashion, and we would have to establish an internal commercial scale
manufacturing capability for TOLAMBA, incurring increased capital and operating costs, delays in
the commercial development of TOLAMBA and higher manufacturing costs than we have experienced to
date.
We have or intend to contract with one or more third parties to conduct our clinical trials for
TOLAMBA and HEPLISAV. If these third parties do not carry out their contractual obligations or meet
expected deadlines, our planned clinical trials may be delayed and we may fail to obtain the
regulatory approvals necessary to commercialize TOLAMBA or HEPLISAV.
We rely on third parties to conduct our planned clinical trials for TOLAMBA or HEPLISAV. If
these third parties do not carry out their contractual duties or obligations or meet expected
deadlines, if the third parties need to be replaced or if the quality or accuracy of the clinical
data they obtain is compromised due to failure to adhere to our clinical protocols or for other
reasons, our planned clinical trials may be extended, delayed or terminated. Any extension, delay
or termination of our trials would delay our ability to commercialize TOLAMBA or HEPLISAV and
generate revenues.
If any products we develop are not accepted by the market or if regulatory agencies limit our
labeling indications or marketing claims, we may be unable to generate significant revenues, if
any.
If we obtain regulatory approval for our product candidates and are able to successfully
commercialize them, our product candidates may not gain market acceptance among physicians,
patients, health care payors and the medical community. The FDA or
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other regulatory agencies could limit the labeling indication for which our product candidates
may be marketed or could otherwise constrain our marketing claims, reducing our or our
collaborators ability to market the benefits of our products to particular patient populations. If
we are unable to successfully market any approved product candidates, or are limited in our
marketing efforts by regulatory limits on labeling indications or marketing claims, our ability to
generate revenues could be significantly impaired.
In particular, treatment with TOLAMBA, if approved, will require a series of injections, and
we expect that some of the patients that currently take oral or inhaled pharmaceutical products to
treat their allergies would not consider using our product. We believe that market acceptance of
TOLAMBA will also depend on our ability to offer competitive pricing, increased efficacy and
improved ease of use as compared to existing or potential new allergy treatments.
We may seek partners for purposes of commercialization of HEPLISAV in selected markets
worldwide. Marketing challenges vary by market and could limit or delay acceptance in any
particular country. We believe that market acceptance of HEPLISAV will depend on our ability to
offer increased efficacy and improved ease of use as compared to existing or potential new
hepatitis B vaccine products.
We face uncertainty related to coverage, pricing and reimbursement and the practices of third party
payors, which may make it difficult or impossible to sell our product candidates on commercially
reasonable terms.
In both domestic and foreign markets, our ability to generate revenues from the sales of any
approved product candidates in excess of the costs of producing the product candidates will depend
in part on the availability of reimbursement from third party payors. Existing laws affecting the
pricing and coverage of pharmaceuticals and other medical products by government programs and other
third party payors may change before any of our product candidates are approved for marketing. In
addition, third party payors are increasingly challenging the price and cost-effectiveness of
medical products and services. Significant uncertainty therefore exists as to coverage and
reimbursement levels for newly approved health care products, including pharmaceuticals. Because we
intend to offer products, if approved, that involve new technologies and new approaches to treating
disease, the willingness of third party payors to reimburse for our products is particularly
uncertain. We will have to charge a price for our products that is sufficiently high to enable us
to recover the considerable capital resources we have spent and will continue to spend on product
development. Adequate third-party reimbursement may not be available to enable us to maintain price
levels sufficient to realize a return on our investment in product development. If it becomes
apparent, due to changes in coverage or pricing of pharmaceuticals in our market or a lack of
reimbursement, that it will be difficult, if not impossible, for us to generate revenues in excess
of costs, we will need to alter our business strategy significantly. This could result in
significant unanticipated costs, harm our future prospects and reduce our stock price.
Many of our competitors have greater financial resources and expertise than we do. If we are unable
to successfully compete with existing or potential competitors despite these disadvantages we may
be unable to generate revenues and our business will be harmed.
We compete with many companies and institutions, including pharmaceutical companies,
biotechnology companies, academic institutions and research organizations, in developing
alternative therapies to treat or prevent allergy, infectious diseases, asthma and cancer, as well
as those focusing more generally on the immune system. Competitors may develop more effective, more
affordable or more convenient products or may achieve earlier patent protection or
commercialization of their products. These competitive products may render our product candidates
obsolete or limit our ability to generate revenues from our product candidates. Many of the
companies developing competing technologies and products have significantly greater financial
resources and expertise in research and development, manufacturing, preclinical and clinical
testing, obtaining regulatory approvals and marketing than we do.
TOLAMBA, if approved, will compete directly with conventional allergy shots and indirectly
with antihistamines, corticosteroids and anti-leukotriene agents, used to treat seasonal allergy
symptoms, including those produced by GSK, Merck, Novartis, Schering-Plough and AstraZeneca Plc.
Since our TOLAMBA ragweed allergy treatment would require a series of injections, we expect that
some patients that currently take oral or inhaled pharmaceutical products to treat their allergies
would not consider our product.
HEPLISAV, if approved, will compete with existing vaccines produced by GSK and Merck, among
others.
Existing and potential competitors may also compete with us for qualified scientific and
management personnel, as well as for technology that would be advantageous to our business. If we
are unable to compete with existing and potential competitors we may not be able to obtain
financing, sell our product candidates or generate revenues.
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We depend on key employees in a competitive market for skilled personnel, and the loss of the
services of any of our key employees would affect our ability to develop and commercialize our
product candidates and achieve our objectives.
We are highly dependent on the principal members of our management, operations and scientific
staff, including our Chief Executive Officer, Dr. Dino Dina. We experience intense competition for
qualified personnel. Our future success also depends in part on the continued service of our
executive management team, key scientific and management personnel and our ability to recruit,
train and retain essential scientific personnel for our drug discovery and development programs,
including those who will be responsible for overseeing our preclinical testing and clinical trials
as well as for the establishment of collaborations with other companies. If we lose the services of
any of these people, our research and product development goals, including the identification and
establishment of key collaborations, operations and marketing efforts could be delayed or
curtailed.
We intend to develop, seek regulatory approval for and market our product candidates outside the
United States, requiring a significant commitment of resources. Failure to successfully manage our
international operations could result in significant unanticipated costs and delays in regulatory
approval or commercialization of HEPLISAV and therapeutic product candidates.
We plan to introduce HEPLISAV initially in various markets outside the United States.
Developing, seeking regulatory approval for and marketing our product candidates outside the United
States could impose substantial burdens on our resources and divert managements attention from
domestic operations. We may also conduct operations in other foreign jurisdictions.
International operations are subject to risk, including:
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the difficulty of managing geographically distant operations, including
recruiting and retaining qualified employees, locating adequate facilities and establishing
useful business support relationships in the local community; |
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compliance with varying international regulatory requirements; |
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securing international distribution, marketing and sales capabilities; |
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adequate protection of our intellectual property rights; |
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difficulties and costs associated with complying with a wide variety of complex international laws and treaties; |
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legal uncertainties and potential timing delays associated with tariffs, export licenses and other trade barriers; |
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adverse tax consequences; |
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the fluctuation of conversion rates between foreign currencies and the U.S. dollar; and |
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geopolitical risks. |
If we are unable to successfully manage our international operations, we may incur significant
unanticipated costs and delays in regulatory approval or commercialization of HEPLISAV and
therapeutic product candidates, as well as other product candidates that we may choose to
commercialize internationally, which would impair our ability to generate revenues.
We recently acquired Rhein Biotech GmbH and any difficulties from integrating the Rheins business
into ours could disrupt our business and harm our financial condition.
On April 21, 2006, we acquired Rhein Biotech GmbH in a cash transaction of approximately $12.5
million, excluding certain employee and transaction related costs and expenses. Through this
acquisition, Dynavax gained ownership of a European Union (EU) GMP-certified vaccine manufacturing
facility in Düsseldorf, Germany, certain vaccine and other commercial programs, a management team
and personnel with specialized expertise in process development and vaccine manufacturing.
Integrating Rheins operations, technology and personnel with our operations and personnel is
a complex process. The successful integration of Dynavax and Rhein will require, among other
things, ongoing coordination of various integration efforts, relating to our personnel system,
technologies and commercial programs. We may not be able to rapidly or efficiently integrate
Rheins business and
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technology into ours and the expected benefits of the combination may not materialize.
Our ability to successfully integrate Rhein involves numerous risks, including:
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difficulties in integrating the operations, technologies, products and
personnel of Rhein; |
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difficulties in successfully utilizing Rheins manufacturing capabilities to
produce materials for our existing product candidates in lieu of purchasing such materials
from third party vendors; |
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diversion of managements attention from normal daily operations of the business; |
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potential difficulties in integrating different projects; |
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difficulties in entering markets in which we have no or limited direct prior
experience and where competitors in such markets have stronger market positions; |
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insufficient revenues to offset increased expenses associated with the acquisition; and |
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potential loss of key employees of Rhein. |
The Rhein acquisition may also cause us to:
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assume liabilities some of which may be unknown at the time of such acquisitions; |
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record certain intangible assets in conjunction with our accounting for the
transaction in the second quarter of 2006 that may be subject to immediate write-off,
ongoing impairment testing, or potential periodic impairment charges, or may cause us to
incur future amortization expenses; or |
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become subject to unknown litigation. |
Moreover, we will be required to include Rhein as part our Sarbanes-Oxley compliance
requirements beginning in 2007. There can be no assurance that we will be able to successfully
integrate Rhein and its technology and personnel into our business.
We use hazardous materials in our business. Any claims or liabilities relating to improper
handling, storage or disposal of these materials could be time consuming and costly to resolve.
Our research and product development activities involve the controlled storage, use and
disposal of hazardous and radioactive materials and biological waste. We are subject to federal,
state and local laws and regulations governing the use, manufacture, storage, handling and disposal
of these materials and certain waste products. We are currently in compliance with all government
permits that are required for the storage, use and disposal of these materials. However, we cannot
eliminate the risk of accidental contamination or injury to persons or property from these
materials. In the event of an accident related to hazardous materials, we could be held liable for
damages, cleanup costs or penalized with fines, and this liability could exceed the limits of our
insurance policies and exhaust our internal resources. We may have to incur significant costs to
comply with future environmental laws and regulations.
We face product liability exposure, which, if not covered by insurance, could result in significant
financial liability.
While we have not experienced any product liability claims to date, the use of any of our
product candidates in clinical trials and the sale of any approved products will subject us to
potential product liability claims and may raise questions about a products safety and efficacy.
As a result, we could experience a delay in our ability to commercialize one or more of our product
candidates or reduced sales of any approved product candidates. In addition, a product liability
claim may exceed the limits of our insurance policies and exhaust our internal resources. We have
obtained limited product liability insurance coverage in the amount of $1 million for each
occurrence for clinical trials with umbrella coverage of an additional $4 million. This coverage
may not be adequate or may not continue to be available in sufficient amounts, at an acceptable
cost or at all. We also may not be able to obtain commercially reasonable product liability
insurance for any product approved for marketing in the future. A product liability claim, product
recalls or other claims, as well as any claims for uninsured liabilities or in excess of insured
liabilities, would divert our managements attention from our business and could result in
significant financial liability.
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If the combination of patents, trade secrets and contractual provisions that we rely on to protect
our intellectual property is inadequate, the value of our product candidates will decrease.
Our success depends on our ability to:
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obtain and protect commercially valuable patents or the rights to patents both domestically and abroad; |
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operate without infringing upon the proprietary rights of others; and |
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prevent others from successfully challenging or infringing our proprietary rights. |
We will be able to protect our proprietary rights from unauthorized use only to the extent
that these rights are covered by valid and enforceable patents or are effectively maintained as
trade secrets. We try to protect our proprietary rights by filing and prosecuting United States and
foreign patent applications. However, in certain cases such protection may be limited, depending in
part on existing patents held by third parties, which may only allow us to obtain relatively narrow
patent protection. In the United States, legal standards relating to the validity and scope of
patent claims in the biopharmaceutical field can be highly uncertain, are still evolving and
involve complex legal and factual questions for which important legal principles remain unresolved.
The biopharmaceutical patent environment outside the United States is even more uncertain. We
may be particularly affected by this uncertainty, given that several of our product candidates may
initially address market opportunities outside the United States. For example, we expect to market
HEPLISAV, if approved, in various foreign countries with high incidences of hepatitis B, including
Canada, Europe and selected markets in Asia, where we may only be able to obtain limited patent
protection.
The risks and uncertainties that we face with respect to our patents and other proprietary
rights include the following:
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we might not have been the first to make the inventions covered by each of our
pending patent applications and issued patents; |
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we might not have been the first to file patent applications for these
inventions; |
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the pending patent applications we have filed or to which we have exclusive
rights may not result in issued patents or may take longer than we expect to result in
issued patents; |
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the claims of any patents that are issued may not provide meaningful protection; |
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our issued patents may not provide a basis for commercially viable products or may not be valid or enforceable; |
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we might not be able to develop additional proprietary technologies that are patentable; |
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the patents licensed or issued to us or our collaborators may not provide a competitive advantage; |
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patents issued to other companies, universities or research institutions may harm our ability to do business; |
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other companies, universities or research institutions may independently
develop similar or alternative technologies or duplicate our technologies and commercialize
discoveries that we attempt to patent; and |
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other companies, universities or research institutions may design around
technologies we have licensed, patented or developed. |
We also rely on trade secret protection and confidentiality agreements to protect our
interests in proprietary know-how that is not patentable and for processes for which patents are
difficult to enforce. We cannot be certain that we will be able to protect our trade secrets
adequately. Any leak of confidential data into the public domain or to third parties could allow
our competitors to learn our trade secrets. If we are unable to adequately obtain or enforce
proprietary rights we may be unable to commercialize our products, enter into collaborations,
generate revenues or maintain any advantage we may have with respect to existing or potential
competitors.
33
We rely on our licenses from the Regents of the University of California. Impairment of these
licenses or our inability to maintain them would severely harm our business.
Our success depends upon our license arrangements with the Regents of the University of
California, or UC. These licenses are critical to our research and product development efforts. Our
dependence on these licenses subjects us to numerous risks, such as disputes regarding the
invention and corresponding ownership rights in inventions and know-how resulting from the joint
creation or use of intellectual property by us and UC, or scientific collaborators. Additionally,
our agreements with UC generally contain diligence or milestone-based termination provisions. Our
failure to meet any obligations pursuant to these provisions could allow UC to terminate any of
these licensing agreements or convert them to non-exclusive licenses. In addition, our license
agreements with UC may be terminated or may expire by their terms, and we may not be able to
maintain the exclusivity of these licenses. If we cannot maintain licenses that are advantageous or
necessary to the development or the commercialization of our product candidates, we may be required
to expend significant time and resources to develop or license similar technology.
Our stock price is subject to volatility, and your investment may suffer a decline in value.
The market prices for securities of biopharmaceutical companies have in the past been, and are
likely to continue in the future to be, very volatile. The market price of our common stock is
subject to substantial volatility depending upon many factors, many of which are beyond our
control, including:
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progress or results of any of our clinical trials, in particular any
announcements regarding the progress or results of our planned trials for TOLAMBA and
HEPLISAV; |
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progress of regulatory approval of our product candidates, in particular
TOLAMBA and HEPLISAV, and compliance with ongoing regulatory requirements; |
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our ability to establish collaborations for the development and commercialization of our product candidates; |
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market acceptance of our product candidates; |
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our ability to raise additional capital to fund our operations, whether through the issuance of equity securities or debt; |
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technological innovations, new commercial products or drug discovery efforts
and preclinical and clinical activities by us or our competitors; |
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changes in our intellectual property portfolio or developments or disputes
concerning the proprietary rights of our products or product candidates; |
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our ability to obtain component materials and successfully enter into
manufacturing relationships for our product candidates or establish manufacturing capacity
on our own; |
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our ability to form strategic partnerships or joint ventures; |
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maintenance of our existing licensing agreements with the Regents of the University of California; |
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changes in government regulations; |
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issuance of new or changed securities analysts reports or recommendations; |
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general economic conditions and other external factors; |
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actual or anticipated fluctuations in our quarterly financial and operating results; and |
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volume of trading liquidity in our common stock |
One or more of these factors could cause a decline in the price of our common stock. In
addition, securities class action litigation has often been brought against a company following a
decline in the market price of its securities. This risk is especially relevant for
34
us because we have experienced greater than average stock price volatility, as have other
biotechnology companies in recent years. We may in the future be the target of similar litigation.
Securities litigation could result in substantial costs, and divert managements attention and
resources, which could harm our business, operating results and financial conditions.
Anti-takeover provisions of our certificate of incorporation, bylaws and Delaware law may prevent
or frustrate a change in control, even if an acquisition would be beneficial to our stockholders,
which could affect our stock price adversely and prevent attempts by our stockholders to replace or
remove our current management.
Provisions of our certificate of incorporation and bylaws may delay or prevent a change in
control, discourage bids at a premium over the market price of our common stock and adversely
affect the market price of our common stock and the voting or other rights of the holders of our
common stock. These provisions include:
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authorizing our Board of Directors to issue additional preferred stock with
voting rights to be determined by the Board of Directors; |
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limiting the persons who can call special meetings of stockholders; |
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prohibiting stockholder actions by written consent; |
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creating a classified board of directors pursuant to which our directors are elected for staggered three year terms; |
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providing that a supermajority vote of our stockholders is required for
amendment to certain provisions of our certificate of incorporation and bylaws; and |
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establishing advance notice requirements for nominations for election to our
Board of Directors or for proposing matters that can be acted on by stockholders at
stockholder meetings. |
In addition, we are subject to the provisions of the Delaware corporation law that, in
general, prohibit any business combination with a beneficial owner of 15% or more of our common
stock for five years unless the holders acquisition of our stock was approved in advance by our
Board of Directors.
We will continue to implement additional finance and accounting systems, procedures or controls as
we grow our business and organization and to satisfy new reporting requirements.
As a public company, we are required to comply with the Sarbanes-Oxley Act of 2002 and the
related rules and regulations of the SEC, including expanded disclosures and accelerated reporting
requirements and more complex accounting rules. Compliance with Section 404 of the Sarbanes-Oxley
Act of 2002 and other requirements may increase our costs and require additional management
resources. We may need to continue to implement additional finance and accounting systems,
procedures and controls as we grow our business and organization and to comply with new reporting
requirements. Specifically, with the Rhein acquisition, we now have foreign operations that will
not later than 2007 be required to meet the Section 404 requirements as part of our operations.
There can be no assurance that we will be able to maintain a favorable assessment as to the
adequacy of our internal control reporting. If we are unable to maintain an unqualified report as
to the effectiveness of our internal controls over financial reporting, investors could lose
confidence in the reliability of our internal controls over financial reporting and the reliability
of our financial statements, which could harm our business and could impact the market price of our
common stock.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On April 18, 2006, pursuant to agreements with Symphony Capital LP discussed in Note 4 to the
Condensed Consolidated Financial Statements included in this Form 10-Q, we issued to Symphony
Holdings LLC a five-year warrant to purchase 2,000,000 shares of our common stock at $7.32 per
share, representing a 25% premium over the applicable 60-day trading range average of $5.86 per
share. The warrant exercise price is subject to reduction to $5.86 per share under certain
circumstances. We filed a registration statement on Form S-3 (File No. 333-134688) on June 1, 2006
covering the resale of share of common stock subject to purchase pursuant to the warrants, and the
warrants were issued pursuant to Rule 506 promulgated under Regulation D.
35
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The Company held its Annual Meeting of Shareholders on June 14, 2006. The proposals voted on
by the Company shareholders and the voting results were as follows:
Proposal 1: Election of Class III Directors
The election of directors was approved as follows:
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For |
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Withhold |
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Daniel S. Janney |
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25,986,718 |
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226,048 |
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Arnold L. Oronsky |
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26,102,663 |
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110,103 |
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Proposal 2: Ratification of Appointment of Independent Registered Public Accounting Firm
Ernst & Young LLP was ratified as the Companys independent registered public accounting firm
for fiscal year 2006 as follows:
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For |
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Against |
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Abstain |
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26,180,441 |
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24,810 |
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7,515 |
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ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
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Exhibit |
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Number |
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Document |
10.19
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2004 Non-employee Director Option Program (Revised) and 2005 Non-employee Director Cash Compensation
Program, effective April 14, 2005 and amended February 23, 2006. |
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10.20*
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Summary of Düsseldorf Lease Agreement as of August 14, 1990, as amended |
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10.21*
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Definitive Commercial Agreement, dated April 21, 2006, among Dynavax Technologies Corporation, Rhein
Biotech NV and Rhein Biotech GmbH |
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10.22*
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Exclusive License Agreement, dated
April 21, 2006, between Green Cross Vaccine Corp. and Rhein
Biotech GmbH |
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10.23*
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Share Sale and Purchase Agreement, dated March 27, 2006, between Dynavax Technologies Corporation and
Rhein Biotech N.V. |
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10.24*
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License and Supply Agreement, dated
February 28, 2002, between Corixa Corporation and Rhein Biotech N.V. |
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10.25*
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Purchase Option Agreement, dated as of April 18, 2006, among Dynavax Technologies Corporation, Symphony
Dynamo Holdings LLC and Symphony Dynamo, Inc. |
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10.26*
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Registration Rights Agreement, dated as of April 18, 2006, between Dynavax Technologies Corporation and
Symphony Dynamo Holdings LLC |
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10.27*
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Warrant Purchase Agreement, dated as of April 18, 2006, between Dynavax Technologies Corporation and
Symphony Dynamo Holdings LLC |
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10.28*
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Amended and Restated Research and Development Agreement, dated as of April 18, 2006, among Dynavax
Technologies Corporation, Symphony Dynamo Holdings LLC and Symphony Dynamo, Inc. |
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10.29*
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Novated and Restated Technology License Agreement, dated as of April 18, 2006, among Dynavax
Technologies Corporation, Symphony Dynamo Holdings LLC and Symphony Dynamo, Inc. |
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21.1*
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List of Subsidiaries |
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31.1*
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Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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31.2*
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Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
36
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Exhibit |
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Number |
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Document |
32.1*
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Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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32.2*
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Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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* |
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Filed herewith |
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We have been granted confidential treatment with respect to certain portions of this
agreement. Omitted portions have been filed separately with the Securities and Exchange Commission. |
37
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto due
authorized, in the City of Berkeley, State of California.
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DYNAVAX TECHNOLOGIES CORPORATION
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By: |
/s/ DINO DINA, M.D.
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Dino Dina, M.D. |
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President, Chief Executive Officer and Director
(Principal Executive Officer) |
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Date: August 4, 2006
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By: |
/s/ DEBORAH A. SMELTZER
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Deborah A. Smeltzer |
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Vice President, Operations and
Chief Financial Officer
(Principal Financial Officer) |
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Date: August 4, 2006
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By: |
/s/ TIMOTHY G. HENN
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Timothy G. Henn |
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Vice President, Finance and Administration and
Chief Accounting Officer
(Principal Accounting Officer) |
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Date: August 4, 2006
38