Prepared By R.R. Donnelley Financial -- Form 8-K
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 8-K
 
Current Report
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  04/28/2009
 
Dynavax Technologies Corporation
(Exact name of registrant as specified in its charter)
 
Commission File Number:  001-34207
 
Delaware
  
33-0728374
(State or other jurisdiction of
  
(IRS Employer
incorporation)
  
Identification No.)
 
2929 Seventh Street, Suite 100
Berkeley, CA 94710-2753
(Address of principal executive offices, including zip code)
 
(510) 848-5100
(Registrant’s telephone number, including area code)
 
(Former name or former address, if changed since last report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 
Item 2.02.    Results of Operations and Financial Condition
 
On April 28, 2009, Dynavax Technologies Corporation issued a press release announcing its financial results for first quarter ended March 31, 2009. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.

The information with respect to item 2.02 in this current report and its accompanying exhibit shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this current report and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax Technologies Corporation, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 
 
Item 9.01.    Financial Statements and Exhibits
 
99.1             Press Release, dated April 28, 2009 titled "Dynavax Announces First Quarter 2009 Financial Results."
 

 

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
     
 
Dynavax Technologies Corporation
 
 
Date: April 28, 2009
     
By:
 
/s/    Deborah A. Smeltzer

               
Deborah A. Smeltzer
               
Vice President, Operations and Chief Financial Officer
 
 


 

Exhibit Index
 
Exhibit No.

  
Description

EX-99.1
  
Press Release, dated April 28, 2009 titled "Dynavax Announces First Quarter 2009 Financial Results."
DC6634.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 
Contacts:     
Deborah A. Smeltzer                 Amy Figueroa 
VP Operations &                 Investor Relations & 
Chief Financial Officer                 Corporate Communications 
510-665-7222                 510-665-7211 
dsmeltzer@dynavax.com                 afigueroa@dynavax.com 

DYNAVAX ANNOUNCES FIRST QUARTER 2009 FINANCIAL RESULTS

BERKELEY, Calif. – April 28, 2009 – Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the first quarter ended March 31, 2009.

Over the coming year, Dynavax intends to advance the development of its diversified pipeline of products to meaningful value inflection points while stringently managing its cash and the resources from partnerships and funding agreements. The Company is in active discussions with regulatory agencies to resolve the U.S. Food and Drug Administration’s clinical hold on HEPLISAV(TM) hepatitis B vaccine and identify an appropriate path for its approval in the United States, Europe, and the rest of the world. The Company continues to work towards clarifying the remaining regulatory and development requirements in the first half of 2009.

Dynavax reported $60.5 million in cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc. (SDI), collectively referred to as total cash, at March 31, 2009. This compared to $68.5 million at December 31, 2008.

Total revenues were $19.3 million for the first quarter 2009, compared to $6.3 million for the first quarter 2008. The significant increase in revenues for the first quarter 2009 was primarily attributable to the recognition of $15.5 million of non-cash deferred revenue following the announcement of the termination of the Merck & Co., Inc. collaboration for HEPLISAV. The Company expects to recognize the remaining $12.9 million of non-cash deferred revenue from this collaboration agreement in the second quarter 2009.

On a pro forma basis, including collaboration funding from SDI, revenues were $20.1 million for the first quarter 2009, compared to $7.8 million for the first quarter 2008.

Total operating expenses were $15.0 million for the first quarter 2009, compared to $19.9 million for the first quarter 2008. The decrease in operating expenses for the first quarter 2009 was primarily due to a reduction in clinical development costs associated with HEPLISAV and the discontinuation of development for the TOLAMBATM ragweed allergy program in May 2008.

On a pro forma basis, excluding the one-time and other non-cash charges for stock-based compensation and amortization of intangible assets, operating expenses were

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DYNAVAX ANNOUNCES FIRST QUARTER 2009 FINANCIAL RESULTS

April 28, 2009 Page 2 of 6

$14.2 million for the first quarter 2009, compared to $19.0 million for the first quarter 2008.

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.

Net income was $5.1 million, or $0.13 per share, for the first quarter 2009, compared to a net loss of $12.4 million, or $0.31 per share, for the first quarter 2008. The net income for the first quarter 2009 is due to the recognition of non-cash deferred revenue and a decrease in total operating expenses.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax’s proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. 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 related to the nature and timing of communications with regulatory agencies regarding HEPLISAV and the Company’s projected cash position and operating results. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in its business, including whether the FDA will remove the clinical hold for HEPLISAV, whether HEPLISAV can be further developed, financed or commercialized, or even if further development is permitted, that successful clinical development and regulatory approval can occur in a timely manner or without significant additional studies and difficulties or delays in development; initiation and completion of clinical trials of the Company’s other product candidates; 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 its operations; and other risks detailed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K. The Company undertakes no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

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DYNAVAX ANNOUNCES FIRST QUARTER 2009 FINANCIAL RESULTS             
April 28, 2009             
Page 3 of 6             
 
DYNAVAX TECHNOLOGIES CORPORATION             
CONSOLIDATED STATEMENTS OF OPERATIONS             
(In thousands, except per share amounts)             
(Unaudited)             
 
        Three Months Ended 
        March 31, 
        2009    2008 
Revenues:             
     Collaboration revenue    $    17,692    $ 5,774 
     Grant revenue        1,139    324 
     Service and license revenue        513    216 



Total revenues        19,344    6,314 
 
Operating expenses:             
     Research and development (1)        10,332    15,120 
     General and administrative (2)        4,424    4,571 
     Amortization of intangible assets        245    245 



Total operating expenses (3)        15,001    19,936 



 
Income (loss) from operations        4,343    (13,622) 
 
Interest income        110    709 
Interest expense        (15)    (1,344) 
Other income (expense)        (346)    262 



 
Net income (loss)        4,092    (13,995) 
 
Add: Losses attributable to noncontrolling interest in SDI        1,009    1,566 



 
Net income (loss) attributable to Dynavax    $    5,101    $(12,429) 


 
Basic and diluted net income (loss) per share attributable to Dynavax             
 common stockholders    $    0.13    $ (0.31) 
Shares used to compute basic and diluted net income (loss) per share             
 attributable to Dynavax common stockholders        39,889    39,785 




(1)      Research and development expenses included non-cash stock-based compensation expense of $19 thousand and $0.2 million for the first quarter ended March 31, 2009 and 2008, respectively.
 
(2)      General and administrative expenses included non-cash stock-based compensation charges of $0.5 million for both the first quarter ended March 31, 2009 and 2008, respectively.
 
(3)      Total operating expenses excluding non-cash stock-based compensation charges were $14.5 million and $19.3 million for the first quarter ended March 31, 2009 and 2008, respectively.
 

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April 28, 2009                 
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DYNAVAX TECHNOLOGIES CORPORATION                 
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES         
(In thousands)                 
(Unaudited)                 
 
    Three Months Ended 
        March 31,     
        2009     2008 
 
GAAP revenues    $    19,344    $    6,314 
 
ADD:                 
Collaboration funding incurred under SDI programs        747        1,531 




Pro forma revenues (1)    $    20,091    $    7,845 





(1)      These pro forma amounts are intended to illustrate the Company’s revenues to be inclusive of collaboration funding provided for the SDI programs. 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 programs funded under the SDI arrangement. 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 
                 March 31, 
    2009    2008 
 
GAAP operating expenses    $15,001    $ 19,936 
LESS:         
Stock-based compensation expense    519    661 
Amortization of intangible assets    245    245 


Pro forma operating expenses (2)    $ 14,237    $ 19,030 

(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 ANNOUNCES FIRST QUARTER 2009 FINANCIAL RESULTS             
April 28, 2009                 
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DYNAVAX TECHNOLOGIES CORPORATION         
SELECTED BALANCE SHEET DATA
(In thousands)
 
 
        March 31,    December 31, 
        2009        2008 
Assets        (unaudited)         
 Cash and cash equivalents and marketable securities (1)    $    60,491    $    68,476 
 Property and equipment, net        8,600        9,510 
 Goodwill        2,312        2,312 
 Other intangible assets, net        2,014        2,259 
 Other assets        4,727        8,066 




Total assets    $    78,144    $    90,623 




 
Liabilities and stockholders’ equity                 
 Accounts payable    $    1,088    $    905 
 Accrued liabilities        6,878        6,816 
 Current portion of deferred revenue        16,154        33,133 
 Noncurrent portion of deferred revenue        18,543        18,512 
 Liability from Program Option exercised under the SDI                 
   collaboration        15,000        15,000 
 Other long-term liabilities        117        101 
 Stockholders’ equity        20,364        16,156 




Total liabilities and stockholders’ equity    $    78,144    $    90,623 





(1)      These amounts also included investments held by SDI of $23.8 million and $25.1 million as of March 31, 2009 and December 31, 2008, respectively.
 

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