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8-K - 8-K - DYNAVAX TECHNOLOGIES CORPrrd324623.htm
EX-99 - PRESS RELEASE, DATED OCTOBER 27, 2011, TITLED "DYNAVAX CONFIRMS HEPLISAV(TM) SUBMISSION STRATEGIES WITH U.S. FDA AND EMA." - DYNAVAX TECHNOLOGIES CORPrrd324623_36314.htm
EX-99 - PRESS RELEASE, DATED OCTOBER 27, 2011, TITLED "DYNAVAX PHASE 3 DATA IN CHRONIC KIDNEY DISEASE DEMONSTRATES SUPERIORITY OF HEPLISAV(TM) VS ENGERIX-B(R)." - DYNAVAX TECHNOLOGIES CORPrrd324623_36313.htm
                                                                                           Exhibit 99.1 
 
                                                                 DYNAVAX 

               DYNAVAX TECHNOLOGIES 
    2929 Seventh Street, Suite 100 
    Berkeley, CA 94710 
 
 
Contacts:     
Jennifer Lew    Michael Ostrach 
Vice President, Finance    Vice President and Chief Business Officer 
510-665-7217    510-665-7257 
jlew@dynavax.com    mostrach@dynavax.com 

DYNAVAX REPORTS THIRD QUARTER 2011 FINANCIAL RESULTS

BERKELEY, CA – October 27, 2011 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2011, including $53.2 million in cash, cash equivalents and marketable securities at September 30, 2011. This amount does not include a total of $8.6 million, consisting of $6 million in previously announced payments from Dynavax’s collaborations with AstraZeneca and GlaxoSmithKline to be made after the close of the quarter and proceeds of $2.6 million from the sale of common stock to Aspire Capital received after the close of the third quarter.

Dynavax said that, based on developments to date and additional potential payments anticipated to be received or earned by year end under existing arrangements, it expects to end 2011 with approximately $50 million in cash, cash equivalents and marketable securities.

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 HEPLISAVTM, 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 net cash usage and cash position. 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

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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.

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DYNAVAX TECHNOLOGIES CORPORATION             
CONSOLIDATED STATEMENTS OF OPERATIONS             
(In thousands, except per share amounts)             
(Unaudited)                         
 
    Three Months Ended    Nine Months Ended 
            September 30,           September 30, 
        2011       2010    2011           2010 
Revenues:                                 
     Collaboration revenue        $    369     $    10,402    $ 7,098    $    19,164 
     Grant revenue            658        1,218    2,437        2,697 
     Service and license revenue            147        29    652        323 


Total revenues            1,174        11,649    10,187        22,184 
 
Operating expenses:                                 
     Research and development            11,777        14,204    39,706        40,729 
     General and administrative            4,217        3,951    13,025        12,694 
     Amortization of intangible assets                    245    299        735 






Total operating expenses            15,994        18,400    53,030        54,158 






 
Loss from operations        (14,820)        (6,751)    (42,843)        (31,974) 
 
Interest income            18        12    74        53 
Interest expense            (485)        (399)    (1,462)        (1,229) 
Other income (expense)            58        2,140    (99)        (9,036) 






 
Net loss    $    (15,229)    $    (4,998)    $ (44,330)        $ (42,186) 
 
Basic and diluted net loss per share    $        (0.12)    $    (0.06)    $ (0.37)        $ (0.57) 
 
Shares used to compute basic net loss per share            124,069        86,826    119,244        74,519 
 
 
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                                                                 DYNAVAX TECHNOLOGIES CORPORATION                 
                             RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES         
    (In thousands)                             
    (Unaudited)                             
 
    Three Months Ended    Nine Months Ended 
        September 30,         September 30, 
        2011        2010        2011        2010 
 
GAAP revenues                                       $    1,174    $    11,649    $     10,187    $     22,184 
 
LESS:                                 
Deferred revenue from collaborations                10,000                              10,000 
Pro forma revenues (1)    $    1,174    $    1,649    $     10,187    $     12,184 





(1)      These pro forma amounts are intended to illustrate the Company’s revenues excluding certain items for which cash was received in a prior period. 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 Ended    Nine Months Ended 
    September 30,    September 30, 
    2011    2010       2011    2010 
 
GAAP operating expenses    $ 15,994    $ 18,400    $ 53,030    $ 54,158 
LESS:                 
Stock-based compensation expense    1,287    586    3,934    1,552 
Amortization of intangible assets        245    299    735 




Pro forma operating expenses (2)    $ 14,707    $ 17,569    $ 48,797    $ 51,871 

(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.
 

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DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
 
    September 30,    December 31, 
        2011        2010 
Assets                 
 Cash and cash equivalents and marketable securities         $    53,221    $    72,154 
 Property and equipment, net        6,127        6,404 
 Goodwill        2,312        2,312 
 Other intangible assets, net                299 
 Other assets        3,059        3,080 




Total assets         $    64,719    $    84,249 




 
Liabilities and stockholders’ equity                 
 Accounts payable         $    1,313    $    2,329 
 Accrued and other liabilities        8,823        11,786 
 Current portion of deferred revenue        1,429        1,429 
 Noncurrent portion of deferred revenue        4,583        5,655 
 Long-term note payable to Holdings        12,342        10,939 
 Stockholders’ equity        36,229        52,111 




Total liabilities and stockholders’ equity         $    64,719    $    84,249 





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