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):  03/12/2010
 
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 1.01.    Entry into a Material Definitive Agreement
 
On March 12, 2010, Dynavax Technologies Corporation ("Dynavax") and Merck Sharp & Dohme Corp. f/k/a Merck & Co., Inc. ("Merck"), entered into a Settlement Agreement under which the parties both agreed that Merck's delivery of a $4 million payment to Dynavax fully, finally and irrevocably satisfies Merck's contractual obligation to reimburse Dynavax for the costs of (a) the Wind Down Activities during the Wind Down Period and (b) any activities conducted by or on behalf of Dynavax under the Development Program pursuant to the License Agreement between Dynavax and Merck dated October 31, 2007 ("License Agreement") or pursuant to the Manufacturing Agreement between Dynavax and Merck dated October 31, 2007 ("Manufacturing Agreement"), including without limitation Merck's obligations under the License Agreement or the Manufacturing Agreement.
 
 
Item 2.02.    Results of Operations and Financial Condition
 
On March 16, 2010, Dynavax issued a press release announcing its financial results for the fourth quarter and year ended December 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, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 
 
Item 8.01.    Other Events
 
On March 15, 2010, Dynavax issued a press release titled "Dynavax and Merck Agree on Final Reimbursements." A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.

On March 16, 2010, Dynavax issued a press release titled "Dynavax Anticipates Earlier BLA Submission for HEPLISAV(TM)." A copy of the press release is attached as Exhibit 99.2 to this current report and is incorporated herein by reference.

 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibit
Exhibit No.        Description
10.51        Settlement Agreement, dated as of March 12, 2010 between Dynavax Technologies Corporation and Merck Sharp & Dohme Corp. f/k/a Merck & Co., Inc.

99.1        Press Release, dated March 15, 2010, titled "Dynavax and Merck Agree on Final Reimbursements"

99.2        Press Release, dated March 16, 2010, titled "Dynavax Anticipates Earlier BLA Submission for HEPLISAV(TM)"

 

 

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: March 16, 2010
     
By:
 
/s/    Michael S. Ostrach

               
Michael S. Ostrach
               
Vice President
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-10.51
  
Settlement Agreement, dated as of March 12, 2010 between Dynavax Technologies Corporation and Merck Sharp & Dohme Corp. f/k/a Merck & Co., Inc.
EX-99.1
  
Press Release, dated March 15, 2010, titled "Dynavax and Merck Agree on Final Reimbursements"
EX-99.2
  
Press Release, dated March 16, 2010, titled "Dynavax Anticipates Earlier BLA Submission for HEPLISAVTM"
DC8548.pdf -- Converted by SEC Publisher 4.2, created by BCL Technologies Inc., for SEC Filing

Exhibit 10.51

SETTLEMENT AGREEMENT

     This Settlement Agreement (the “Agreement”) is made and entered into as of March 12, 2010 (the “Effective Date”) by and between Merck Sharp & Dohme Corp. f/k/a Merck & Co., Inc. (“Merck”), a New Jersey corporation with its principal place of business at Whitehouse Station, New Jersey, and Dynavax Technologies Corporation (“Dynavax”), a Delaware corporation with its principal place of business at Berkeley, California (each individually a “Party” and, collectively, the “Parties”).

RECITALS

     WHEREAS, the Parties entered into an Exclusive License and Development Collaboration Agreement (the “License Agreement”) and a Manufacturing Agreement (the “Manufacturing Agreement”), each dated as of October 31, 2007, concerning the investigational hepatitis B vaccine known as HEPLISAV™; and WHEREAS, on March 17, 2008, the United States Food and Drug Administration (the “FDA”) placed a clinical hold on the Parties’ Investigational New Drug (“IND”) applications for HEPLISAV™; and WHEREAS, by letter dated December 18, 2008, Merck notified Dynavax that it was exercising its right to terminate the License Agreement pursuant to Section 10.2.1 thereof and the Manufacturing Agreement pursuant to Section 12.3 thereof; and WHEREAS, pursuant to Section 10.4.3(f) of the License Agreement, for the period from December 18, 2008 through June 18, 2009 (the “Wind Down Period”), Merck remained responsible for any Development Program (as that term is defined in the


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License Agreement) costs, including non-cancellable costs, incurred by Dynavax in accordance with Section 2.3 of the License Agreement; and WHEREAS, pursuant to Section 10.4.3(f) of the License Agreement, Dynavax was required to cooperate with Merck and take commercially reasonable steps to terminate all planned Development Program activities being conducted by, or on behalf of, Dynavax and to minimize any further Development Program costs (the “Wind Down Activities”); and WHEREAS, the Parties dispute the extent to which Merck is contractually obligated to reimburse Dynavax for the Wind Down Activities during the Wind Down Period; and WHEREAS, without any admission on the part of either Party, the Parties wish to fully and finally settle their dispute concerning the extent to which Merck is contractually obligated to reimburse Dynavax for the Wind Down Activities during the Wind Down Period; NOW, THEREFORE, in consideration of the foregoing and the mutual promises, covenants and agreements contained in this Agreement, and for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1. Settlement Payment

Within fifteen days of Merck’s receipt of a copy of this Agreement duly executed

by Dynavax, Merck will make a one-time, lump-sum payment (the “Settlement


3

Payment”) to Dynavax of Four Million Dollars ($4,000,000.00), by wire transfer to the

following account:

State Street Bank & Trust Company 1200 Crown Colony Quincy, MA 02169

ABA Routing # 011000028 Account # 17039843 For credit to: DE0575

Account Name: DYNAVAX TECHNOLOGIES CORPORATION Attention: Jim Hall Phone: 617-537-3007

     2. Merck’s delivery of the Settlement Payment to Dynavax fully, finally and irrevocably satisfies Merck’s contractual obligation to reimburse Dynavax for the costs of (a) the Wind Down Activities during the Wind Down Period (b) and any activities conducted by or on behalf of Dynavax under the Development Program or pursuant to the Manufacturing Agreement, including without limitation Merck’s obligations under the License Agreement or the Manufacturing Agreement.

     3. Each Party (on behalf of itself and its parent, affiliates, subsidiaries, successors and assigns, past and present officers, directors, employees, agents and representatives) releases, relinquishes and forever discharges the other Party and its parent, affiliates, subsidiaries, successors and assigns, past and present officers, directors, employees, agents and representatives, from and against any and all claims, demands, causes of action, costs, fees, liabilities and expenses of any kind or nature, whether known or unknown, disclosed or undisclosed, arising out of or related in any way to costs of (a) the Wind Down Activities and (b) any activities conducted by or on


4

behalf of a Party under the Development Program or pursuant to the Manufacturing Agreement, including without limitation Merck’s obligations under the License Agreement or the Manufacturing Agreement. Notwithstanding anything to the contrary in this Agreement, nothing in this Agreement shall be construed as the granting of a license, or covenant not to sue, by Merck under Merck’s patent rights, Merck Know-How (as that term is defined in the License Agreement) or other intellectual property controlled by Merck or its affiliates.

     4. Authority. By executing this Agreement, each Party represents and warrants that the person signing the Agreement on its behalf is authorized to do so.

     5. Construction/Severability. This Agreement has been jointly negotiated and drafted by the Parties, and shall not be construed for or against any Party hereto. If any term or other provision of this Agreement is determined to be invalid, illegal or incapable of being enforced by any rule of law or public policy, all other terms and provisions of this Agreement shall remain in full force and effect.

6. Waiver of Unknown Claims. In giving the releases set forth in this

Agreement, which include claims that may be unknown to a Party at present, each Party acknowledges that it has read and understand Section 1542 of the California Civil Code which reads as follows: “A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her must have materially affected his or her settlement with the debtor.” Each Party hereby expressly waives and relinquishes all


5

rights and benefits under that section and any law or legal principle of similar effect in

any jurisdiction with respect to the releases granted herein.

7. Arbitration. Any dispute, controversy or claim between or among the

Parties arising out of or relating to this Agreement, or the breach thereof, shall be

resolved by arbitration as provided in Section 12.6 of the License Agreement.

     8. Applicable Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York without reference to any rules of conflict of laws.

     9. Binding Effect. The provisions of this Agreement shall be binding on and inure to the benefit of the Parties and their respective successors, assigns, administrators and trustees.

     10. Entire Agreement; Amendment. This Agreement constitutes the full and entire understanding and agreement among the Parties with regard to the subject matter hereof. This Agreement is executed without reliance on any promise, warranty or representation by any Party or any representative of any Party other than those representations expressly set forth herein. Neither this Agreement nor any term hereof may be amended, waived, discharged or terminated other than by a written instrument signed by the Party against whom enforcement of any such amendment, waiver, discharge or termination is sought.

     11. Counterparts. This Agreement may be executed in one or more counterparts (including via facsimile transmission), all of which shall be considered one and the same agreement and shall become effective when one or more counterparts


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have been signed by each Party and received by the other Party, it being understood

that the Parties need not sign the same counterpart.

IN WITNESS WHEREOF, Parties have duly executed this Agreement as of the

Effective Date set forth above.

MERCK SHARP & DOHME CORP. f/k/a/
MERCK & CO., INC.

By: /s/ Richard Kender
____________________
Print Name: Richard Kender________________
Title:
Senior Vice President, Business Development and Corporate Licensing
_______

DYNAVAX TECHNOLOGIES

By: /s/Dino Dina, M.D.____________________
Print Name:
Dino Dina, M.D.
_______________
Title: President and Chief Executive Officer ___


DC8549.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:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
mostrach@dynavax.com

DYNAVAX AND MERCK AGREE ON FINAL REIMBURSEMENTS

Merck to Make $4 million Payment to Dynavax

BERKELEY, CA, March 15, 2010 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the successful completion of negotiations relating to Merck’s reimbursement obligations under the former partnership agreements covering the clinical development and commercialization of HEPLISAV™, Dynavax’s enhanced hepatitis B vaccine. Merck has agreed to make a $4.0 million payment to Dynavax covering expenses for the wind down period that followed its December 2008 written notification of the collaboration’s conclusion.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.

About Hepatitis B Vaccines

Currently available hepatitis B vaccines require three doses over six months to achieve full immunogenicity in healthy patient populations. Because compliance with this vaccine regimen is low, new vaccines are needed to provide increased protection in a shorter timeframe.

Furthermore, currently available vaccines do not fully address the needs of several patient populations, including those with chronic kidney disease, HIV or chronic liver disease. In particular, patients with comprised immune systems require both rapid and enhanced protection, either because they are less responsive to conventional vaccine regimens or because they are at high risk of infection.

– more –


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, an 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.

Forward-looking Statements

This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including expectations of clinical trial regulatory requirements 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 or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV, the commercial potential for HEPLISAV and 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.

# # #


DC8550.pdf -- Converted by SEC Publisher 4.2, created by BCL Technologies Inc., for SEC Filing
                                                                                           Exhibit 99.2 
 
                                                                 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 ANTICIPATES EARLIER BLA SUBMISSION FOR HEPLISAV™

2009 Financial Results Reviewed

BERKELEY, CA – March 16, 2010 – Dynavax Technologies Corporation (NASDAQ: DVAX) today said that its large-scale Phase 3 study of HEPLISAVis fully enrolled, with immunization of subjects proceeding in accordance with the pre-specified safety monitoring plan. Dynavax indicated that it expects immunization of all 2,000 subjects with HEPLISAV in the lot-to-lot consistency study will be completed in the near future, an achievement that creates the opportunity to submit a BLA in the third quarter of 2011, approximately six months earlier than previously projected.

According to Dino Dina, M.D., President and CEO, “The accelerated enrollment and immunization of subjects for the safety and consistency study of HEPLISAV is an important accomplishment that we expect will facilitate the successful conclusion of several ongoing financing discussions. Clearly, this is our highest priority to ensure the success of the program.”

Dynavax separately reported $36.7 million in unrestricted cash and cash equivalents at December 31, 2009. This compares to $46.4 million at September 30, 2009, of which $21.7 million were investments held by Symphony Dynamo, Inc. (SDI). The $9.7 million burn for the fourth quarter primarily reflected intensified activities relating to the initiation of the two Phase 3 multi-center trials for HEPLISAV in the U.S., Canada and Germany. The year-end 2009 results do not include a $4.0 million payment due from Merck as announced this week. The results do not reflect a separate $1.8 million payment from AstraZeneca representing a reimbursement adjustment for 2009 and prior periods.

Today Dynavax filed its annual report on Form 10-K for the fiscal year ended December 31, 2009 with the Securities and Exchange Commission (SEC). As a result of the Company’s current financial position, Dynavax’s independent registered public accounting firm has included a statement regarding the Company’s ability to continue as a going concern in its unqualified opinion contained in the Form 10-K. This announcement is being made in compliance with NASDAQ Marketplace Rule 4350(b)(1)(B), which requires separate disclosure of a recent audit opinion that contains “going concern” explanatory language. Management’s plan to address the Company’s liquidity requirements and a more detailed discussion of the financial results is provided in the Form 10-K.

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.

– more –


About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.

About Hepatitis B Vaccines

Currently available hepatitis B vaccines require three doses over six months to achieve full immunogenicity in healthy patient populations. Because compliance with this vaccine regimen is low, new vaccines are needed to provide increased protection in a shorter timeframe. Furthermore, currently available vaccines do not fully address the needs of several patient populations, including those with chronic kidney disease, HIV or chronic liver disease. In particular, patients with comprised immune systems require both rapid and enhanced protection, either because they are less responsive to conventional vaccine regimens or because they are at high risk of infection.

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, an 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.

Forward Looking Statements

This press release contains “forward-looking statements,” that are subject to a number of risks and uncertainties, including statements relating to clinical trial status, BLA submission and financing. 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.

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                                                                 DYNAVAX TECHNOLOGIES CORPORATION                     
CONSOLIDATED STATEMENTS OF OPERATIONS                 
(In thousands, except per share amounts)                     
(Unaudited)                                 
 
            Three Months Ended    Twelve Months Ended 
            December 31,             December 31, 
            2009        2008        2009        2008 
Revenues:                                     
     Collaboration revenue    $        1,455    $    10,231    $    35,534    $    31,666 
     Grant revenue            556        972        3,477        2,999 
     Service and license revenue            178        742        1,307        2,429 




Total revenues            2,189        11,945        40,318        37,094 
 
Operating expenses:                                     
     Research and development (1)            9,506        6,249        38,708        44,771 
     General and administrative (2)            4,052        3,559        15,745        15,463 
     Amortization of intangible assets            245        245        980        980 








Total operating expenses (3)            13,803        10,053        55,433        61,214 








 
Loss from operations            (11,614)        1,892        (15,115)        (24,120) 
 
Interest income            4        170        178        1,631 
Loan forgiveness                                    5,000 
Interest expense            (4)        (16)        (124)        (9,157) 
Other income (expense)            (26)        114        (66)        110 








 
Net income (loss)            (11,640)        2,160        (15,127)        (26,536) 
 
Consideration paid in excess of carrying value of the                                 
 noncontrolling interest in SDI            (19,671)                (19,671)         
Add: Losses attributed to noncontrolling interest in                                     
 SDI            1,041        939        4,233        5,707 








 
Net income (loss) attributable to Dynavax        $ (30,270)    $    3,099    $ (30,565)    $ (20,829) 


 
Basic net income (loss) per share attributable to                                     
 Dynavax common stockholders        $    (0.73)    $    0.08    $    (0.76)    $    (0.52) 
 
Shares used to compute basic net income (loss) per                                 
 share attributable to Dynavax common                                     
 stockholders            41,420        39,854        40,350        39,819 


 
Diluted net income (loss) per share attributable to                                     
 Dynavax common stockholders        $    (0.73)    $    0.08    $    (0.76)    $    (0.52) 
 
Shares used to compute diluted net income (loss)                                     
 per share attributable to Dynavax common                                     
 stockholders            41,420        39,854        40,350        39,819 



(1)      Research and development expenses included non-cash stock-based compensation charges of $0.3 million and $1.1 million for the fourth quarter and year ended December 31, 2009, respectively. Research and development expenses included non-cash stock-based compensation charges of $0.4 million and $1.4 million for the fourth quarter and year ended December 31, 2008, respectively.
 
(2)      General and administrative expenses included non-cash stock-based compensation charges of $0.6 million and $1.9 million for the fourth quarter and year ended December 31, 2009, respectively. General and administrative expenses included non-cash stock-based compensation charges of $0.4 million and $1.8 million for the fourth quarter and year ended December 31, 2008, respectively.
 
(3)      Total operating expenses excluding non-cash stock-based compensation charges were $12.9 million and $52.4 million for the fourth quarter and year ended December 31, 2009, respectively. Total operating expenses excluding non-cash stock-based compensation charges were $9.3 million and $58.0 million for the fourth quarter and year ended December 31, 2008, respectively.
 

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                                                                 DYNAVAX TECHNOLOGIES CORPORATION                 
                             RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES         
(In thousands)                             
(Unaudited)                                 
 
    Three Months Ended    Twelve Months Ended 
        December 31,         December 31, 
        2009        2008        2009        2008 
 
GAAP revenues    $       2,189    $    11,945     $     40,318    $    37,094 
 
ADD:                                 
Collaboration funding incurred under SDI programs        813        744        3,364        5,349 
LESS:                                 
Non-cash deferred revenue from Merck                                 
collaboration                3,086         28,485        4,965 








Pro forma revenues (1)    $       3,002    $    9,603     $     15,197    $    37,478 







(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    Twelve Months Ended 
    December 31,    December 31, 
    2009    2008    2009    2008 
 
GAAP operating expenses    $ 13,803    $ 10,053    $ 55,433    $ 61,214 
LESS:                 
Stock-based compensation expense    933    717    3,035    3,205 
Amortization of intangible assets    245    245    980    980 




Pro forma operating expenses (2)    $ 12,625    $ 9,091    $ 51,418    $ 57,029 

(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)
 
    December 31,    December 31, 
        2009        2008 
Assets                 
 Cash and cash equivalents and marketable securities (1)    $    36,720    $    68,476 
 Property and equipment, net        7,997        9,510 
 Goodwill        2,312        2,312 
 Other intangible assets, net        1,279        2,259 
 Other assets        2,162        8,066 




Total assets    $    50,470    $    90,623 




 
Liabilities and stockholders’ equity                 
 Accounts payable    $    1,686    $    905 
 Accrued liabilities        7,507        6,816 
 Warrant liability to Holdings        2,567         
 Current portion of deferred revenue        2,718        33,133 
 Noncurrent portion of deferred revenue        17,083        18,512 
 Liability from program option exercised under the SDI                 
   collaboration                15,000 
 Long-term note payable to Holdings        9,342         
 Long-term contingent liability to Holdings        3,040         
 Other long-term liabilities        151        101 
 Stockholders’ equity        6,376        16,156 




Total liabilities and stockholders’ equity    $    50,470    $    90,623 





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

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