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 with respect to Item 2.02 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
99.2 Press Release, dated August 5, 2008 entitled "Dynavax and Merck & Co., Inc. Announce Phase 3 Trial with Investigational Hepatitis B Vaccine (HEPLISAV) Met its Primary Endpoint"
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Dynavax Technologies Corporation
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Date: August 05, 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 August 5, 2008 entitled "Dynavax Announces Second Quarter 2008 Financial Results."
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EX-99.2
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Press release, dated August 5, 2008 entitled "Dynavax and Merck & Co., Inc. Announce Phase 3 Trial with Investigational Hepatitis B Vaccine (HEPLISAV) Met its Primary Endpoint"
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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 SECOND QUARTER 2008 FINANCIAL RESULTS
Revenues Increase for Quarter, Per Share Net Loss Narrows
BERKELEY, Calif. - August 5, 2008 - Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the second quarter and six months ended June 30, 2008.
As of June 30, 2008, Dynavax reported cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc. (SDI) totaling $63.1 million. This compares to $88.2 million at December 31, 2007.
For the second quarter 2008, total revenues were $10.0 million, compared to $1.8 million reported for the second quarter in 2007. Revenues for the six months ended 2008 were $16.3 million, compared to $3.8 million for the same period in 2007. The increase in revenues for the second quarter and year-to-date reflects research and development funding under our collaboration with Merck & Co. Inc. (Merck) for HEPLISAVTM, our hepatitis B vaccine product candidate. The reported revenues do not include collaboration funding from Symphony Dynamo Inc. (SDI) for cancer and HCV clinical activities. On a pro forma basis, including the collaboration funding from SDI, revenues were $11.4 million and $19.3 million for the three and six months ended June 30, 2008, respectively, compared to $4.9 million and $10.4 million for the same periods in 2007.
For the second quarter 2008, total operating expenses were $16.6 million, compared to $23.6 million for the second quarter in 2007. Operating expenses for the six months ended 2008 were $36.5 million, compared to $41.7 million for the same period in 2007. The decline in operating expenses for the second quarter and year-to-date resulted primarily from a reduction in clinical development costs. The operating expenses in 2007 also included a one-time license payment for the commercialization of HEPLISAV. Excluding the one-time and other non-cash charges for stock-based compensation and amortization of intangible assets, pro forma operating expenses were $15.6 million and $34.6 million for the three and six months ended June 30, 2008, respectively, compared to $17.7 million and $34.7 million for the same periods in 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.
- more -
The net loss of $6.1 million, or $0.15 per share, reported for the second quarter 2008 improved from the net loss of $17.7 million, or $0.45 per share, for the same period in 2007. The net loss of $18.5 million, or $0.47 per share, reported for the six months ended 2008 was also significantly less than the net loss of $30.8 million, or $0.78 per share, for the same period in 2007. For the second quarter and year-to-date, the improvement in net loss reflected the increase in revenues, in particular, revenue associated with the Merck collaboration.
Webcast Today
Dynavax will webcast a discussion of the HEPLISAV Phase 3 data announced today along with the company's second quarter 2008 financial results on Tuesday, August 5, 2008 at 4:30 p.m. Eastern Daylight Time / 1:30 p.m. Pacific Daylight Time. The webcast can be accessed on Dynavax's website at
http://investors.dynavax.com/events.cfm. A telephonic replay of the discussion will be available through August 19, 2008 by dialing 1-888-203-1112, access code: 4643391. International callers can dial 1-719-457-0820, access code: 4643391.About Dynavax
http://www.dynavax.com.Forward-looking Statements
This press release contains forward-looking statements 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; achieving our Merck collaborative agreement objectives, resuming development and obtaining regulatory approval for HEPLISAV; continuation of our 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 obliga tion 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 June 30, |
Six Months Ended June 30, |
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2008 |
2007 |
2008 |
2007 |
Revenues: |
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Collaboration revenue |
$ 7,701 |
$ 752 |
$ 13,475 |
$ 1,499 |
Grant revenue |
1,122 |
587 |
1,446 |
1,715 |
Service and license revenue |
1,155 |
461 |
1,371 |
570 |
Total revenues |
9,978 |
1,800 |
16,292 |
3,784 |
Operating expenses: |
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Research and development (2) |
12,946 |
19,164 |
28,066 |
32,796 |
General and administrative (3) |
3,420 |
4,206 |
7,991 |
8,386 |
Amortization of intangible assets |
245 |
252 |
490 |
503 |
Total operating expenses (1) |
16,611 |
23,622 |
36,547 |
41,685 |
Loss from operations |
(6,633) |
(21,822) |
(20,255) |
(37,901) |
Interest and other income, net |
405 |
1,118 |
1,376 |
2,119 |
Interest expense |
(1,340) |
(37) |
(2,684) |
(65) |
Loss including noncontrolling interest in Symphony Dynamo, Inc. (SDI). |
(7,568) |
(20,741) |
(21,563) |
(35,847) |
Amount attributed to noncontrolling interest in SDI |
1,489 |
3,037 |
3,055 |
5,053 |
Net loss |
$ (6,079) |
$ (17,704) |
$ (18,508) |
$ (30,794) |
Basic and diluted net loss per share |
$ (0.15) |
$ (0.45) |
$ (0.47) |
$ (0.78) |
Shares used to compute basic and diluted net loss per share |
39,806 |
39,741 |
39,795 |
39,734 |
- more -
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
(In thousands)
(Unaudited)
Three Months Ended June 30, |
Six Months Ended June 30, |
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2008 |
2007 |
2008 |
2007 |
GAAP revenues |
$ 9,978 |
$ 1,800 |
$ 16,292 |
$ 3,784 |
ADD: Collaboration funding incurred under SDI programs |
1,432 |
3,136 |
2,963 |
6,632 |
Pro forma revenues (1) |
$ 11,410 |
$ 4,936 |
$ 19,255 |
$ 10,416 |
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES
(In thousands)
(Unaudited)
Three Months Ended June 30, |
Six Months Ended June 30, |
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2008 |
2007 |
2008 |
2007 |
GAAP operating expenses |
$ 16,611 |
$ 23,622 |
$ 36,547 |
$ 41,685 |
LESS: Stock-based compensation expense |
775 |
689 |
1,436 |
1,497 |
Licensing fee |
- |
5,000 |
- |
5,000 |
Amortization of intangible assets |
245 |
252 |
490 |
503 |
Pro forma operating expenses (2) |
$ 15,591 |
$ 17,681 |
$34,621 |
$ 34,685 |
- more -
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
June 30, |
December 31, |
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2008 |
2007 |
Assets |
(unaudited) |
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Cash and cash equivalents and marketable securities (1) |
$ 63,115 |
$ 88,248 |
Property and equipment, net |
11,165 |
7,314 |
Goodwill |
2,312 |
2,312 |
Other intangible assets, net |
2,749 |
3,239 |
Other assets |
17,597 |
19,336 |
Total assets |
$ 96,938 |
$ 120,449 |
Liabilities, noncontrolling interest and stockholders' equity |
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Current liabilities |
$ 15,442 |
$ 19,904 |
Noncurrent portion of deferred revenue |
39,785 |
40,792 |
Liability from Program Option exercised under the SDI collaboration |
15,000 |
15,000 |
Other long-term liabilities |
7,611 |
5,622 |
Noncontrolling interest in SDI. |
5,286 |
8,341 |
Stockholders' equity |
13,814 |
30,790 |
Total liabilities, noncontrolling interest and stockholders' equity |
$ 96,938 |
$ 120,449 |
# # #
News Release
Dynavax Contact: |
Merck Contacts: |
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Shari Annes |
Eva Boratto |
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Investor Relations |
Investor Relations |
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Media |
1-908-423-5185 |
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1-650-888-0902 |
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1-510-665-7210 |
Tracy Ogden |
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sannes@dynavax .com |
Global Communications |
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1-215-652-0344 |
Dynavax and Merck & Co., Inc. Announce Phase 3 Trial with Investigational Hepatitis B Vaccine (HEPLISAV™) Met its Primary Endpoint
BERKELEY, CA and WHITEHOUSE STATION, NJ - August 5, 2008 - Dynavax Technologies Corporation (Nasdaq: DVAX) and Merck & Co., Inc. announced today top-line immunogenicity results from a Phase 3 clinical trial comparing HEPLISAV™, an investigational hepatitis B virus (HBV) vaccine, to a currently marketed HBV vaccine, Engerix-B® *. The study achieved its primary endpoint. HEPLISAV is being jointly developed by Dynavax and Merck for use in adults and in patients with end stage renal disease.
This study, called PHAST (Phase 3 HeplisAv Short-regimen Trial), evaluated a two-dose regimen of HEPLISAV administered at 0 and 1 month compared to a three-dose regimen of Engerix-B® administered at 0, 1 and 6 months. The primary endpoint was the proportion of subjects who developed protective antibodies to hepatitis B after administration. In PHAST, 95.1 percent of subjects who received two doses of HEPLISAV (n=1,819) developed protective antibodies to hepatitis B when measured at 12 weeks versus 81.1 percent of subjects who received three doses of Engerix-B® (n=608) when measured at 28 weeks. The multi-center study evaluated 2,427 subjects from 11 to 55 years of age in Canada and Germany. Results of additional analyses from this trial will be presented in the future.
As previously disclosed, the U.S. Food and Drug Administration (FDA) placed a clinical hold on the two Investigational New Drug (IND) Applications for HEPLISAV that is still in effect. In issuing the clinical hold, the FDA requested a review of clinical and preclinical safety data for HEPLISAV. Additionally, the FDA requested all available information about a single case of Wegener's granulomatosis reported in this Phase 3 trial.
HEPLISAV is based on Dynavax's proprietary immunostimulatory sequence (ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to stimulate an innate immune response. HEPLISAV combines ISS with HBV surface antigen (HBsAg) and is designed to enhance the speed of protection.
- more -
Webcast Today
Dynavax will webcast a discussion of the HEPLISAV Phase 3 data along with the company's second quarter 2008 financial results on Tuesday, August 5, 2008 at 4:30 p.m. Eastern Daylight Time / 1:30 p.m. Pacific Daylight Time. The webcast can be accessed on Dynavax's website at
http://investors.dynavax.com/events.cfm. A telephonic replay of the discussion will be available through August 19, 2008 by dialing 1-888-203-1112, access code: 4643391. International callers can dial 1-719-457-0820, access code: 4643391.About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergy, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Our clinical product candidates include: HEPLISAV, a hepatitis B vaccine partnered with Merck & Co., Inc.; a therapy for metastatic colorectal cancer; and therapies for hepatitis B and C. Our preclinical asthma and COPD program is partnered with AstraZeneca. The NIH partially funds our preclinical universal influenza vaccine program that is being coordinated with Novartis. Symphony Dynamo Inc. (SDI) funds our colorectal cancer and hepatitis C therapeutic programs. While the NIH and SDI provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit
http://www.dynavax.com.DYNAVAX Forward-Looking Statement
This press release contains "forward-looking statements." 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; achieving our Merck collaborative agreement objectives and obtaining regulatory approval for HEPLISAV; 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.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit
www.merck.com.- more -
Merck Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk facto rs or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
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