Delaware
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33-0728374
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(State or other jurisdiction of
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(IRS Employer
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incorporation)
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Identification No.)
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The information in this current report and its accompanying exhibit shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this current report and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax Technologies Corporation, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Exhibit No. Description
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Dynavax Technologies Corporation
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Date: November 03, 2008
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By:
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/s/ Deborah A. Smeltzer
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Deborah A. Smeltzer
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Vice President, Operations and Chief Financial Officer
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Exhibit No.
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Description
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EX-99.1
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Press Release, dated November 3, 2008 entitled "Dynavax Announces Third Quarter 2008 Financial Results."
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Exhibit 99.1
Dynavax Technologies
2929 Seventh Street, Suite 100 Berkeley, CA 94710
Contact
Deborah A. Smeltzer
VP Operations & Chief Financial Officer
Phone: (510) 665-7222
Email:
dsmeltzer@dynavax.com
DYNAVAX ANNOUNCES THIRD QUARTER 2008 FINANCIAL RESULTS
Revenues and Cash Increase for Quarter, Per Share Net Loss Narrows
BERKELEY, Calif. - November 3, 2008 - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter and nine months ended September 30, 2008.
Dynavax's cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc. (SDI) totaled $64.3 million at September 30, 2008. This compared to $63.1 million at June 30, 2008 and $88.2 million at December 31, 2007.
"Our increase in cash reflects the achievement of a $4.5 million milestone payment from AstraZeneca, increased revenues from our collaboration and funding agreements, and a commitment to aggressively manage our cash burn rate," said Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "We expect to end this year with over $50 million in total cash, which gives us the flexibility to advance the development of our diversified pipeline of products for at least two years. For HEPLISAVTM, we are working with our global partner Merck and expect to define our next steps by the end of this year, which may include the worldwide end-stage renal disease and adult markets outside of the U.S., representing a significant portion of the total opportunity for this investigational hepatitis B vaccine."
For the third quarter 2008, total revenues were $8.9 million, compared to $1.0 million reported for the third quarter of 2007. Revenues for the nine months ended September 30, 2008 were $25.1 million, compared to $4.8 million for the same period of 2007. The increase in revenues for the third quarter and nine months reflects research and development funding under the company's collaboration with Merck & Co. Inc. (Merck) for HEPLISAV. The reported revenues do not include collaboration funding from SDI for cancer and HCV clinical development. On a pro forma basis, including the collaboration funding from SDI, revenues were $10.5 million and $29.8 million for the three and nine months ended September 30, 2008, respectively, compared to $2.9 million and $13.3 million for the same periods of 2007.
For the third quarter 2008, total operating expenses were $14.6 million, compared to $20.2 million for the third quarter of 2007. Operating expenses for the nine months ended September 30, 2008 were $51.2 million, compared to $61.9 million for the same period of 2007. The decline in operating expenses for the third quarter and nine months
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resulted primarily from a reduction in clinical development costs. The operating expenses for the nine month period of 2007 also included a one-time license payment for the commercialization rights to HEPLISAV. Excluding the one-time and other non-cash charges for stock-based compensation and amortization of intangible assets, pro forma operating expenses were $13.3 million and $47.9 million for the three and nine months ended September 30, 2008, respectively, compared to $19.0 million and $53.6 million for the same periods of 2007.
The tables included as part of this press release provide a reconciliation of GAAP revenues and operating expenses to pro forma revenues and operating expenses.
The net loss of $5.4 million, or $0.14 per share, reported for the third quarter 2008 improved from the net loss of $17.1 million, or $0.43 per share, for the same period of 2007. The net loss of $23.9 million, or $0.60 per share, reported for the nine months ended September 30, 2008 was also significantly less than the net loss of $47.9 million, or $1.21 per share, for the same period of 2007. For the third quarter and nine months, the improvement in net loss reflected the increase in revenues, in particular, revenue associated with the Merck collaboration for HEPLISAV.
About Dynavax
Dynavax Technologies Corporation is a clinical-stage biopharmaceutical company that develops innovative products for the treatment of infectious diseases, respiratory diseases and cancer. The company's novel Toll-like Receptor 9 (TLR9) agonist products are based on its proprietary immunostimulatory sequences (ISS), which are short DNA sequences that stimulate the innate immune response. Dynavax's clinical product candidates include: HEPLISAV, a hepatitis B vaccine partnered with Merck & Co., Inc.; a therapy for hepatitis B; and therapies for cancer and hepatitis C funded by Symphony Dynamo, Inc. The company's preclinical pipeline includes an asthma and COPD drug candidate partnered with AstraZeneca AB and a Universal Flu vaccine. For more information, visit
www.dynavax.com.Forward-looking Statements
This press release contains "forward-looking statements", including statements about our projected cash position and usage and the timing of the definition of our next steps and clarification of the opportunity for HEPLISAV in certain markets, that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in development, initiation and completion of clinical trials, the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process, including whether and under what conditions the FDA clinical hold on HEPLISAV may be removed; maintaining our Merck collaborative agreement; potential for resuming development and obtaining regulatory approval for HEPLISAV; continuation of our other third party collaboration and funding arrangements; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available
- tables to follow -
DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended September 30, |
Nine Months Ended September 30, |
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2008 |
2007 |
2008 |
2007 |
Revenues: |
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Collaboration revenue |
$ 7,960 |
$ 719 |
$ 21,435 |
$ 2,218 |
Grant revenue |
581 |
133 |
2,027 |
1,848 |
Service and license revenue |
316 |
162 |
1,687 |
732 |
Total revenues |
8,857 |
1,014 |
25,149 |
4,798 |
Operating expenses: |
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Research and development (2) |
10,456 |
14,909 |
38,522 |
47,705 |
General and administrative (3) |
3,913 |
5,029 |
11,904 |
13,414 |
Amortization of intangible assets |
245 |
251 |
735 |
754 |
Total operating expenses (1) |
14,614 |
20,189 |
51,161 |
61,873 |
Loss from operations |
(5,757) |
(19,175) |
(26,012) |
(57,075) |
Interest and other income |
81 |
476 |
1,457 |
2,594 |
Loan forgiveness |
5,000 |
- |
5,000 |
- |
Interest expense |
(6,457) |
(23) |
(9,141) |
(88) |
Loss including noncontrolling interest in SDI. |
(7,133) |
(18,722) |
(28,696) |
(54,569) |
Amount attributed to noncontrolling interest in SDI |
1,713 |
1,621 |
4,768 |
6,674 |
Net loss |
$ (5,420) |
$ (17,101) |
$ (23,928) |
$ (47,895) |
Basic and diluted net loss per share |
$ (0.14) |
$ (0.43) |
$ (0.60) |
$ (1.21) |
Shares used to compute basic and diluted net loss per share |
39,831 |
39,753 |
39,807 |
39,740 |
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DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
(In thousands)
(Unaudited)
Three Months Ended September 30, |
Nine Months Ended September 30, |
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2008 |
2007 |
2008 |
2007 |
GAAP revenues |
$ 8,857 |
$ 1,014 |
$ 25,149 |
$ 4,798 |
ADD: Collaboration funding incurred under SDI programs |
1,642 |
1,855 |
4,605 |
8,487 |
Pro forma revenues (1) |
$ 10,499 |
$ 2,869 |
$ 29,754 |
$ 13,285 |
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES
(In thousands)
(Unaudited)
Three Months Ended September 30, |
Nine Months Ended September 30, |
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2008 |
2007 |
2008 |
2007 |
GAAP operating expenses |
$ 14,614 |
$ 20,189 |
$ 51,161 |
$ 61,873 |
LESS: Stock-based compensation expense |
1,052 |
984 |
2,488 |
2,481 |
Licensing fee |
- |
- |
- |
5,000 |
Amortization of intangible assets |
245 |
251 |
735 |
754 |
Pro forma operating expenses (2) |
$ 13,317 |
$ 18,954 |
$47,938 |
$ 53,638 |
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DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
September 30, |
December 31, |
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2008 |
2007 |
Assets |
(unaudited) |
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Cash and cash equivalents and marketable securities (1) |
$ 64,261 |
$ 88,248 |
Property and equipment, net |
10,241 |
7,314 |
Goodwill |
2,312 |
2,312 |
Other intangible assets, net |
2,504 |
3,239 |
Other assets |
8,241 |
19,336 |
Total assets |
$ 87,559 |
$ 120,449 |
Liabilities, noncontrolling interest and stockholders' equity |
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Current liabilities |
$ 19,890 |
$ 19,904 |
Noncurrent portion of deferred revenue |
39,188 |
40,792 |
Liability from Program Option exercised under the SDI collaboration |
15,000 |
15,000 |
Other long-term liabilities |
106 |
5,622 |
Noncontrolling interest in SDI. |
3,573 |
8,341 |
Stockholders' equity |
9,802 |
30,790 |
Total liabilities, noncontrolling interest and stockholders' equity |
$ 87,559 |
$ 120,449 |
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