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Dynavax Reports Fourth Quarter and Year End 2012 Financial Results

Companies mentioned in this article: Dynavax Technologies

BERKELEY, CA -- (Marketwire) -- 03/01/13 -- 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:

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

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