News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Dynavax Technologies Corporation (DVAX) Reports Fourth Quarter and Year End 2012 Financial Results



3/4/2013 9:16:40 AM

BERKELEY, CA--(Marketwire - March 01, 2013) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2012. The Company had $125.1 million in cash, cash equivalents and marketable securities as of December 31, 2012, following the fourth quarter repayment of a $15 million note at its maturity and receipt of $6 million from AstraZeneca, Dynavax's collaboration partner for its asthma program.

For the quarter ended December 31, 2012, Dynavax reported total revenues of $1.8 million compared to $11.4 million for the quarter ended December 31, 2011. Collaboration revenue in the fourth quarter of 2011 was higher due to the recognition of certain milestones achieved under Dynavax's partnership with GlaxoSmithKline.

Research and development expenses for the quarter ended December 31, 2012 of $12.5 million increased by $0.9 million from the fourth quarter of 2011 resulting from growth in the organization associated with manufacturing and regulatory activities for HEPLISAV™.

General and administrative expenses for the quarter ended December 31, 2012 of $9.3 million increased by $4.7 million primarily due to higher non-cash stock-based compensation charges of $2.4 million, as well as increased administrative headcount and market research costs supporting HEPLISAV.

For the year ended December 31, 2012, total revenues were $9.7 million compared to $21.6 million in 2011. Research and development expenses for the year ended December 31, 2012 of $49.1 million decreased by $2.2 million from the prior year resulting from lower HEPLISAV clinical trial expenses. General and administrative expenses for the year ended December 31, 2012 of $28.2 million increased by $10.6 million primarily due to market research expenses and other corporate development activities supporting HEPLISAV, growth in the organization, and increased non-cash stock-based compensation charges.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine for which U.S. and European licensure applications have been accepted for review by the FDA and the EMA. In February 2013, Dynavax received a Complete Response Letter from the FDA. Dynavax plans to meet with the FDA in the near term to discuss the steps necessary for potential approval of HEPLISAV. Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.

Forward-Looking Statements

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 our ability to meet with the FDA in the near term; whether successful clinical and regulatory development and review and approval of HEPLISAV and our process for its manufacture can occur without significant delay or additional studies; whether our studies and manufacturing efforts can support registration for commercialization of HEPLISAV; 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 the BLA and the European licensure application will be approved; our ability to obtain additional financing to support the development and commercialization of HEPLISAV and our other operations; possible claims against us, including enjoining sales of HEPLISAV, based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

- tables to follow -

DYNAVAX TECHNOLOGIES CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) Three Months Ended Years Ended December 31, December 31, -------------------- -------------------- 2012 2011 2012 2011 --------- --------- --------- --------- Revenues: Collaboration revenue $ 1,008 $ 10,092 $ 4,610 $ 17,190 Grant revenue 751 673 3,939 3,110 Services and license revenue 47 662 1,165 1,314 --------- --------- --------- --------- Total revenues 1,806 11,427 9,714 21,614 Operating expenses: Research and development 12,515 11,616 49,146 51,322 General and administrative 9,293 4,545 28,164 17,570 Amortization of intangible assets - - - 299 --------- --------- --------- --------- Total operating expenses 21,808 16,161 77,310 69,191 --------- --------- --------- --------- Loss from operations (20,002) (4,734) (67,596) (47,577) Interest income 83 29 291 103 Interest expense (586) (495) (2,351) (1,957) Other income (expense) (38) 933 (293) 834 --------- --------- --------- --------- Net loss $ (20,543) $ (4,267) $ (69,949) $ (48,597) ========= ========= ========= ========= Basic and diluted net loss per share $ (0.11) $ (0.03) $ (0.41) $ (0.39) Shares used to compute basic and diluted net loss per share 180,685 142,482 170,469 125,101 ========= ========= ========= ========= DYNAVAX TECHNOLOGIES CORPORATION SELECTED BALANCE SHEET DATA (In thousands) (Unaudited) December 31, December 31, 2012 2011 ------------- ------------- Assets Cash, cash equivalents and marketable securities $ 125,130 $ 113,961 Property and equipment, net 7,965 6,163 Goodwill 2,475 2,312 Other assets 4,182 11,666 ------------- ------------- Total assets $ 139,752 $ 134,102 ============= ============= Liabilities and stockholders'equity Deferred revenues $ 12,068 $ 10,596 Short-term note payable - 12,810 Other liabilities 12,858 10,816 ------------- ------------- Total liabilities 24,926 34,222 Stockholders' equity 114,826 99,880 ------------- ------------- Total liabilities and stockholders' equity $ 139,752 $ 134,102 ============= =============


Contacts:
Jennifer Lew
Vice President, Finance
510-665-7217
Email Contact

Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact


Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES