EX-99.1 2 rrd290428_33326.htm PRESS RELEASE, DATED NOVEMBER 4, 2010 TITLED "DYNAVAX REPORTS 2010 THIRD QUARTER FINANCIAL RESULTS." DC9591.pdf -- Converted by SEC Publisher 4.2, created by BCL Technologies Inc., for SEC Filing

Exhibit 99.1

DYNAVAX

DYNAVAX TECHNOLOGIES
2929 Seventh Street, Suite 100
Berkeley, CA 94710

  Contact:
Jennifer Lew
Vice President, Finance
510-665-7217
jlew@dynavax.com

DYNAVAX REPORTS 2010 THIRD QUARTER FINANCIAL RESULTS

BERKELEY, CA – November 4, 2010 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2010, including $47.2 million in cash, cash equivalents and marketable securities. This compared to $57.4 million at June 30, 2010. In November 2010, the Company received $42.7 million from the successful completion of a public offering and a grant covering certain research costs, resulting in current cash, cash equivalents and marketable securities in excess of $83 million as of the date of this release.

In particular, the $47.2 million in reported cash at September 30, 2010 does not reflect the net proceeds of $42.0 million from the Company’s public offering and $0.7 million in grants under The Patient Protection and Affordable Care Act of 2010 covering research and development costs from 2009 and 2010 for three of the Company’s qualified therapeutic discovery projects including HEPLISAVTM. The $10.2 million net cash usage reported for the third quarter 2010 included a $2.0 million initial purchase of the Company’s common stock by Aspire Capital Fund, LLC that the Company received upon executing its September 2010 financing arrangement.

Total revenues of $11.6 million for the third quarter 2010 included recognition of the $10.0 million upfront payment received from AstraZeneca in 2006 following the recent amendment of our collaboration agreement. This compared to $2.9 million reported for the third quarter in 2009.

Total operating expenses of $18.4 million for the third quarter 2010, driven by continued clinical and manufacturing activities for HEPLISAV, were consistent with the $18.5 million reported for the second quarter 2010. Total operating expenses for the third quarter 2009 of $13.6 million were lower prior to restarting the HEPLISAV clinical program in September 2009.

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 diseases. The company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.

– tables to follow –


                                                                 DYNAVAX TECHNOLOGIES CORPORATION             
CONSOLIDATED STATEMENTS OF OPERATIONS             
                                                                   (In thousands, except per share amounts)             
(Unaudited)                         
 
        Three Months Ended    Nine Months Ended 
        September 30,             September 30, 
        2010         2009       2010        2009 
Revenues:                             
     Collaboration revenue    $    10,402    $    1,791    $ 19,164    $    34,079 
     Grant revenue        1,218        887    2,697        2,921 
     Service and license revenue        29        223    323        1,129 







Total revenues        11,649        2,901    22,184        38,129 
 
Operating expenses:                             
     Research and development        14,204        9,631    40,729        29,202 
     General and administrative        3,951        3,736    12,694        11,693 
     Amortization of intangible assets        245        245    735        735 







Total operating expenses        18,400        13,612    54,158        41,630 







 
Loss from operations        (6,751)        (10,711)    (31,974)        (3,501) 
 
Interest income        12        18    53        174 
Interest expense        (399)        (93)    (1,229)        (120) 
Other income (expense)        2,140        80    (9,036)        (40) 







 
Net loss        (4,998)        (10,706)    (42,186)        (3,487) 
 
Add: Losses attributed to noncontrolling interest in                             
 SDI                1,200            3,192 




 
Net loss attributable to Dynavax    $    (4,998)    $    (9,506)    $ (42,186)    $    (295) 


 
Basic and diluted net loss per share attributable to                             
 Dynavax stockholders    $    (0.06)    $    (0.24)    $ (0.57)    $    (0.01) 
Shares used to compute basic and diluted net loss                             
per share attributable to Dynavax stockholders        86,826        40,153    74,519        39,990 
 
– more –                             


                                                                 DYNAVAX TECHNOLOGIES CORPORATION                 
                             RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES         
(In thousands)                             
(Unaudited)                                 
 
    Three Months Ended    Nine Months Ended 
         September 30,         September 30, 
        2010        2009        2010        2009 
 
GAAP revenues    $     11,649    $    2,901    $     22,184    $    38,129 
 
ADD:                                 
Collaboration funding incurred under SDI programs                         1,009                             2,551 
 
LESS:                                 
Non-cash deferred revenue from collaborations         10,000                 10,000        28,485 




Pro forma revenues (1)    $    1,649    $    3,910    $     12,184    $    12,195 





(1)      These pro forma amounts are intended to illustrate the Company’s revenues including collaboration funding provided for the SDI programs and excluding certain non-cash items. The collaboration funding is reflected in the amount attributed to the noncontrolling interest in SDI in the Company’s consolidated statement of operations, but 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 Ended    Nine Months Ended 
    September 30,    September 30, 
    2010    2009    2010    2009 
 
GAAP operating expenses    $ 18,400    $ 13,612    $ 54,158    $ 41,630 
LESS:                 
Stock-based compensation expense    586    916    1,552    2,102 
Amortization of intangible assets    245    245    735    735 




Pro forma operating expenses (2)    $ 17,569    $ 12,451    $ 51,871    $ 38,793 

(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.
 

– more –


DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
 
    September 30,    December 31, 
        2010        2009 
Assets                 
 Cash and cash equivalents and marketable securities    $    47,231    $    36,720 
 Property and equipment, net        6,634        7,997 
 Goodwill        2,312        2,312 
 Other intangible assets, net        544        1,279 
 Other assets        5,069        2,162 




Total assets    $    61,790    $    50,470 




 
Liabilities and stockholders’ equity                 
 Accounts payable    $    2,067    $    1,686 
 Accrued liabilities        17,530        7,507 
 Warrant liability to Holdings                2,567 
 Current portion of deferred revenue        1,429        2,718 
 Noncurrent portion of deferred revenue        6,012        17,083 
 Long-term note payable to Holdings        10,540        9,342 
 Long-term contingent liability to Holdings        944        3,040 
 Other long-term liabilities        60        151 
 Stockholders’ equity        23,208        6,376 




Total liabilities and stockholders’ equity    $    61,790    $    50,470 





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