Dynavax Reports Fourth Quarter and Year End 2012 Financial Results

Marketwired

BERKELEY, CA--(Marketwire - Mar 1, 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
Contact:

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

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

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