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):  10/22/2009
 
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 October 22, 2009, Dynavax Technologies Corporation ("Dynavax"), issued a press release announcing its financial results for third quarter ended September 30, 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, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibits
Exhibit No.    Description
99.1             Press Release, dated October 22, 2009 titled "Dynavax Announces Third 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: October 22, 2009
     
By:
 
/s/    Jennifer Lew

               
Jennifer Lew
               
Vice President, Finance and Principal Accounting Officer
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-99.1
  
Press Release, dated October 22, 2009 titled "Dynavax Announces Third Quarter 2009 Financial Results."
DC7616.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:     
Jennifer Lew           Amy Figueroa 
Vice President, Finance           Investor Relations & Corporate 
           Communications 
510-665-7217           510-665-7211 
jlew@dynavax.com           afigueroa@dynavax.com 

DYNAVAX ANNOUNCES THIRD QUARTER 2009 FINANCIAL RESULTS

To Host Webcast of Conference Call Today at 4:30 pm EDT

BERKELEY, Calif. – October 22, 2009 – Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the third quarter and nine months ended September 30, 2009.

Dynavax reported $46.4 million in cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc. (SDI), collectively referred to as total cash, at September 30, 2009. This compared to $53.0 million at June 30, 2009.

“During the third quarter, we began the first of two planned Phase 3 registration trials for our lead product HEPLISAVTM and our goal is to complete these trials within 24 months,” commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. “With our commercialization strategy focused on directly serving high-value markets in the U.S. and a partnering strategy to expand into broader market segments and internationally, HEPLISAV can become a company-building product for Dynavax.”

Total revenues for the third quarter 2009 were $2.9 million, compared to $8.9 million reported for the third quarter in 2008. The decline in total revenues for the third quarter was primarily due to a decrease in collaboration revenue following the termination of the Merck & Co., Inc. collaboration for HEPLISAV. Total revenues were $38.1 million for the nine months ended September 30, 2009, compared to $25.1 million for the same period in 2008. The increase in revenues for the nine months ended September 30, 2009 was primarily attributable to the recognition of $28.5 million of non-cash deferred revenue that was accelerated upon the termination of the Merck collaboration.

On a pro forma basis, including collaboration funding from SDI and excluding the non-cash deferred revenue from the Merck collaboration, revenues were $3.9 million and $12.2 million, respectively, for the third quarter and nine months ended September 30, 2009, compared to $9.9 million and $27.9 million for the same period in 2008.

Total operating expenses were $13.6 million for the third quarter 2009, compared to $14.6 million for the third quarter 2008. Total operating expenses were $41.6 million for the nine months ended September 30, 2009, compared to $51.2 million for the same period in 2008. The decrease in operating expenses for 2009 was primarily due to a reduction in clinical development costs associated with HEPLISAV and the discontinuation of development for the TOLAMBA ragweed allergy program in May 2008.

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DYNAVAX ANNOUNCES THIRD QUARTER 2009 FINANCIAL RESULTS

October 22, 2009 Page 2 of 6

On a pro forma basis, excluding the non-cash charges for stock-based compensation and amortization of intangible assets, operating expenses were $12.5 million and $38.8 million, respectively, for the third quarter and nine months ended September 30, 2009, compared to $13.3 million and $47.9 million for the same periods in 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.

The net loss of $9.5 million, or $0.24 per share, reported for the third quarter 2009 increased from the net loss of $5.4 million, or $0.14 per share, for the same period in 2008. The increase in net loss for third quarter is due to a decrease in collaboration revenue partially offset by a decrease in total operating expenses. The net loss of $0.3 million, or $0.01 per share, reported for the nine months ended September 30, 2009 significantly improved compared to the net loss of $23.9 million, or $0.60 per share, for the same period in 2008. The improvement in net loss for the nine months ended September 30, 2009 is due to the recognition of non-cash deferred revenue and a decrease in total operating expenses.

HEPLISAV Phase 3 Hepatitis B Vaccine - In a previously completed pivotal Phase 3 trial, HEPLISAV provided increased, rapid protection with fewer doses than current licensed vaccines. To complete the registration trials for HEPLISAV, Dynavax has begun vaccinating chronic kidney disease patients in a Phase 3 trial and expects to begin a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010. Dynavax will present chronic kidney disease patient data for HEPLISAV at the Infectious Disease Society of America (IDSA) meeting in Philadelphia, Pennsylvania, October 29 through November 1, 2009.

Phase 1b Hepatitis C Therapy - SD-101 is a second generation TLR-9 agonist which is being developed in an ongoing Phase 1b trial funded through the SDI agreement. Dynavax and Symphony Capital are evaluating future development options for this hepatitis C therapy.

Phase 1b Hepatitis B Therapy - In 2009, Dynavax plans to begin a Phase 1b trial of DV-601, the first hepatitis B therapy to combine both surface and core HBV antigens.

Preclinical Programs – Dynavax’s preclinical programs include a unique Universal Flu vaccine and programs partnered with pharmaceutical partners AstraZeneca and GlaxoSmithKline.

Conference Call

Dynavax will webcast a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT). The live and archived webcast can be accessed by visiting the investor relations section of the Company's Web site at http://investors.dynavax.com/newsevents.cfm.

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

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DYNAVAX ANNOUNCES THIRD QUARTER 2009 FINANCIAL RESULTS

October 22, 2009 Page 3 of 6

Forward Looking Statements

This press release contains “forward-looking statements,” that are subject to a number of risks and uncertainties, including statements relating to planned clinical trials and our commercialization strategy for HEPLISAV. 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, whether the studies can support registration for commercialization of HEPLISAV, 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 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.

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DYNAVAX ANNOUNCES THIRD QUARTER 2009 FINANCIAL RESULTS                     
October 22, 2009                                 
Page 4 of 6                                 
 
                                                             DYNAVAX TECHNOLOGIES CORPORATION                 
CONSOLIDATED STATEMENTS OF OPERATIONS             
(In thousands, except per share amounts)                 
    (Unaudited)                             
 
            Three Months Ended        Nine Months Ended 
            September 30,             September 30, 
            2009        2008        2009       2008 
Revenues:                                 
     Collaboration revenue    $        1,791    $    7,960    $    34,079    $ 21,435 
     Grant revenue            887        581        2,921    2,027 
     Service and license revenue            223        316        1,129    1,687 





Total revenues            2,901        8,857        38,129    25,149 
 
Operating expenses:                                 
     Research and development (1)            9,631        10,456        29,202    38,522 
     General and administrative (2)            3,736        3,913        11,693    11,904 
     Amortization of intangible assets            245        245        735    735 







Total operating expenses (3)            13,612        14,614        41,630    51,161 







 
Loss from operations            (10,711)        (5,757)        (3,501)    (26,012) 
 
Interest income            18        313        174    1,461 
Loan Forgiveness                    5,000            5,000 
Interest expense            (93)        (6,457)        (120)    (9,141) 
Other income (expense)            80        (232)        (40)    (4) 







 
Net loss            (10,706)        (7,133)        (3,487)    (28,696) 
 
Add: Losses attributed to noncontrolling interest in                             
 SDI            1,200        1,713        3,192    4,768 







 
Net loss attributable to Dynavax        $    (9,506)    $    (5,420)    $    (295)    $ (23,928) 


 
Basic and diluted net loss per share        $    (0.24)    $    (0.14)    $    (0.01)    $ (0.60) 
 
Shares used to compute basic and diluted net loss                             
 per share            40,153        39,831        39,990    39,807 


(1)      Research and development expenses included non-cash stock-based compensation charges of $0.4 million and $0.8 million for the three and nine months ended September 30, 2009, respectively. Research and development expenses included non-cash stock-based compensation charges of $0.5 million and $1.0 million for the three and nine months ended September 30, 2008, respectively.
 
(2)      General and administrative expenses included non-cash stock-based compensation charges of $0.5 million and $1.3 million for the three and nine months ended September 30, 2009, respectively. General and administrative expenses included non-cash stock-based compensation charges of $0.6 million and $1.4 million for the three and nine months ended September 30, 2008, respectively.
 
(3)      Total operating expenses excluding non-cash stock-based compensation charges were $12.7 million and $39.5 million for the three and nine months ended September 30, 2009, respectively. Total operating expenses excluding non-cash stock-based compensation charges were $13.6 million and $48.7 million for the three and nine months ended September 30, 2008, respectively.
 

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DYNAVAX ANNOUNCES THIRD QUARTER 2009 FINANCIAL RESULTS                         
October 22, 2009                                 
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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, 
        2009     2008       2009     2008 
 
GAAP revenues    $    2,901    $    8,857    $    38,129    $    25,149 
 
ADD:                                 
Collaboration funding incurred under SDI programs        1,009        1,642        2,551        4,605 
LESS:                                 
Non-cash deferred revenue from Merck                                 
collaboration                596        28,485        1,879 








Pro forma revenues (1)    $    3,910    $    9,903    $    12,195    $    27,875 





(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, 
    2009    2008    2009    2008 
 
GAAP operating expenses    $ 13,612    $ 14,614    $ 41,630    $ 51,161 
LESS:                 
Stock-based compensation expense    916    1,052    2,102    2,488 
Amortization of intangible assets    245    245    735    735 




Pro forma operating expenses (2)    $ 12,451    $ 13,317    $ 38,793    $ 47,938 

(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 THIRD QUARTER 2009 FINANCIAL RESULTS             
October 22, 2009                 
Page 6 of 6                 
 
DYNAVAX TECHNOLOGIES CORPORATION         
SELECTED BALANCE SHEET DATA
(In thousands)
 
 
    September 30,    December 31, 
        2009        2008 
Assets        (unaudited)         
 Cash and cash equivalents and marketable securities (1)    $    46,432    $    68,476 
 Property and equipment, net        8,507        9,510 
 Goodwill        2,312        2,312 
 Other intangible assets, net        1,524        2,259 
 Other assets        2,869        8,066 




Total assets    $    61,644    $    90,623 




 
Liabilities and stockholders’ equity                 
 Accounts payable    $    1,037    $    905 
 Accrued liabilities        7,356        6,816 
 Current portion of deferred revenue        3,127        33,133 
 Noncurrent portion of deferred revenue        17,440        18,512 
 Liability from Program Option exercised under the SDI                 
   collaboration        15,000        15,000 
 Other long-term liabilities        160        101 
 Stockholders’ equity        17,524        16,156 




Total liabilities and stockholders’ equity    $    61,644    $    90,623 





(1)      These amounts also included investments held by SDI of $21.7 million and $25.1 million as of September 30, 2009 and December 31, 2008, respectively.
 

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