SOURCE: Dynavax Technologies

Dynavax Technologies

March 08, 2011 09:00 ET

Dynavax Reports Fourth Quarter and Year End 2010 Financial Results

BERKELEY, CA--(Marketwire - March 8, 2011) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2010.

Dynavax reported $72.2 million in cash, cash equivalents and marketable securities at December 31, 2010. This compared to $36.7 million at December 31, 2009. Total cash at the 2010 year end included approximately $83 million in net proceeds from public offerings completed during the year.

Total revenues were $1.8 million for the fourth quarter 2010, compared to $2.2 million for the fourth quarter 2009. Total revenues were $24.0 million for the year ended December 31, 2010, compared to $40.3 million for 2009. The decline in total revenues for the year was primarily due to the recognition of collaboration revenue in June 2009 from our terminated collaboration with Merck.

Total operating expenses were $17.4 million for the fourth quarter 2010, compared to $13.8 million for the fourth quarter 2009. Total operating expenses were $71.5 million for the year ended December 31, 2010, compared to $55.4 million for 2009. The increase in total operating expenses for the year was due to continued clinical and manufacturing activities to support HEPLISAV™. The Company expects total operating expenses in 2011 to be consistent with 2010.

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.

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 designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.

Forward Looking Statements

This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including statements regarding our projected 2011 operating expenses. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies 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; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company 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 the Company's 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   Twelve Months Ended
                                   December 31,           December 31,
                                --------------------  --------------------
                                  2010       2009       2010       2009
                                ---------  ---------  ---------  ---------
Revenues:
  Collaboration revenue         $     371  $   1,455  $  19,535  $  35,534
  Grant revenue                     1,243        556      3,940      3,477
  Service and license revenue         152        178        475      1,307
                                ---------  ---------  ---------  ---------
Total revenues                      1,766      2,189     23,950     40,318

Operating expenses:
  Research and development         12,951      9,506     53,680     38,708
  General and administrative        4,185      4,052     16,879     15,745
  Amortization of intangible
   assets                             245        245        980        980
                                ---------  ---------  ---------  ---------
Total operating expenses           17,381     13,803     71,539     55,433
                                ---------  ---------  ---------  ---------

Loss from operations              (15,615)   (11,614)   (47,589)   (15,115)

Interest income                        32          4         85        178
Interest expense                     (425)        (4)    (1,654)      (124)
Other income (expense)                886        (26)    (8,150)       (66)
                                ---------  ---------  ---------  ---------

Net loss                         (15,122)   (11,640)   (57,308)   (15,127)

Consideration paid in excess of
 carrying value of the
 noncontrolling interest in
 SDI(1)                                --    (19,671)        --    (19,671)
Add: Losses attributed to
 noncontrolling interest in
 SDI                                   --      1,041         --      4,233
                                ---------  ---------  ---------  ---------

Net loss attributable to
 Dynavax                        $ (15,122) $ (30,270) $ (57,308) $ (30,565)
                                =========  =========  =========  =========

Basic and diluted net loss per
 share attributable to Dynavax
 common stockholders            $   (0.14) $   (0.73) $   (0.69) $   (0.76)
                                =========  =========  =========  =========

Shares used to compute basic
 and diluted net loss per share
 attributable to Dynavax common
 stockholders                     106,035     41,420     82,463     40,350
                                =========  =========  =========  =========


     (1) Symphony Dynamo, Inc.



                     DYNAVAX TECHNOLOGIES CORPORATION
          RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
                              (In thousands)
                                (Unaudited)



                                          Three Months      Twelve Months
                                             Ended              Ended
                                           December 31,      December 31,
                                        ----------------- -----------------
                                          2010     2009     2010     2009
                                        -------- -------- -------- --------

GAAP total revenues                     $  1,766 $  2,189 $ 23,950 $ 40,318
ADD:
Collaboration funding for SDI
 programs                                     --      813       --    3,364
LESS:
Recognition of deferred revenue
 from collaborations                          --       --   10,000   28,485
                                        ======== ======== ======== ========
Pro forma total revenues(1)             $  1,766 $  3,002 $ 13,950 $ 15,197
                                        ======== ======== ======== ========


     (1) These pro forma amounts are intended to illustrate the Company's
     revenues including collaboration funding provided for the SDI programs
     and excluding certain other items. The collaboration funding is the
     amount attributed to the noncontrolling interest in SDI in the
     Company's consolidated statement of operations that would have been
     reported as revenue if SDI's results of operations were not
     consolidated with those of the Company. Management of the Company
     believes the pro forma results are a more useful measure of the
     Company's revenues because it provides investors the ability to
     evaluate the Company's operations in the manner that management uses
     to assess the continued progress of operating programs. These pro
     forma results are not in accordance with, or an alternative for,
     generally accepted accounting principles and may be different from pro
     forma measures used by other companies.



                     DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES
                              (In thousands)
                                (Unaudited)



                                          Three Months      Twelve Months
                                             Ended              Ended
                                           December 31,     December 31,
                                        ----------------- -----------------
                                          2010     2009     2010     2009
                                        -------- -------- -------- --------

GAAP total operating expenses           $ 17,381 $ 13,803 $ 71,539 $ 55,433
LESS:
Stock-based compensation expense             858      933    2,410    3,035
Amortization of intangible assets            245      245      980      980
                                        -------- -------- -------- --------
Pro forma total operating expenses(2)   $ 16,278 $ 12,625 $ 68,149 $ 51,418
                                        ======== ======== ======== ========


     (2)  These pro forma amounts are intended to illustrate the Company's
     operating expenses excluding certain non-cash charges in accordance
     with the financial statements that management uses to evaluate the
     Company's operations. These pro forma results are not in accordance
     with, or an alternative for, generally accepted accounting principles
     and may be different from pro forma measures used by other companies.



                     DYNAVAX TECHNOLOGIES CORPORATION
                        SELECTED BALANCE SHEET DATA
                              (In thousands)
                                (Unaudited)



                                                  December 31, December 31,
                                                      2010         2009
                                                  ------------ ------------
Assets
  Cash, cash equivalents and marketable
   securities                                     $     72,154 $     36,720
  Property and equipment, net                            6,404        7,997
  Goodwill                                               2,312        2,312
  Other intangible assets, net                             299        1,279
  Other assets                                           3,080        2,162
                                                  ------------ ------------
Total assets                                      $     84,249 $     50,470
                                                  ============ ============

Liabilities and stockholders' equity
  Accounts payable                                $      2,329 $      1,686
  Accrued liabilities                                   10,943        7,507
  Warrant liability to Holdings                             --        2,567
  Current portion of deferred revenue                    1,429        2,718
  Noncurrent portion of deferred revenue                 5,655       17,083
  Long-term note payable to Holdings                    10,939        9,342
  Long-term contingent liability to Holdings               843        3,040
  Other long-term liabilities                               --          151
  Total stockholders' equity                            52,111        6,376
                                                  ------------ ------------
Total liabilities and stockholders' equity        $     84,249 $     50,470
                                                  ============ ============


Contact Information

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

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