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):  05/06/2010
 
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 2.02.    Results of Operations and Financial Condition
 
On May 6, 2010, Dynavax Technologies Corporation ("Dynavax"), issued a press release announcing its financial results for first quarter ended March 31, 2010. 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 May 6, 2010, Cooley LLP, counsel to Dynavax, issued an opinion relating to the sale by Dynavax of 800,860 shares of common stock under that certain Equity Distribution Agreement dated as of August 17, 2009 by and between Dynavax and Wedbush Morgan Securities, Inc. for the period beginning January 1, 2010 through March 31, 2010. A copy of the opinion is attached as Exhibit 5.1 to this current report and is incorporated herein by reference.
 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibit
Exhibit No.        Description
5.1        Opinion of Cooley LLP.
99.1        Press Release, dated May 6, 2010 titled "Dynavax Reports 2010 First Quarter 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: May 06, 2010
     
By:
 
/s/    Michael S. Ostrach

               
Michael S. Ostrach
               
Vice President
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-99.1
  
Press Release, dated May 6, 2010 titled "Dynavax Reports 2010 First Quarter Financial Results."
EX-5.1
  
Opinion of Cooley LLP.
DC8792.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 FIRST QUARTER FINANCIAL RESULTS

Conference Call and Webcast Today at 4:30 pm EDT

BERKELEY, CA – May 6, 2010 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the first quarter ended March 31, 2010, including $30.1 million in cash and cash equivalents. Total cash for the first quarter 2010 does not include $41 million in net proceeds from the public offering completed on April 16, 2010.

“With the completion of the recent financing, we are poised to achieve our most critical goals, including completion of the Phase 3 study required for submitting our BLA for HEPLISAVTM, initiating clinical development for our Universal Flu and TLR autoimmune products, and positioning hepatitis B and C therapeutics for out-licensing,” noted Dino Dina, M.D., President and CEO.

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.

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 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.

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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 trials and BLA submission. 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.

– tables to follow –


DYNAVAX TECHNOLOGIES CORPORATION         
CONSOLIDATED STATEMENTS OF OPERATIONS         
(In thousands, except per share amounts)         
(Unaudited)                 
 
        Three Months Ended 
            March 31, 
         2010        2009 
Revenues:                 
     Collaboration revenue    $    7,421    $    17,692 
     Grant revenue        862        1,139 
     Service and license revenue        61        513 
Total revenues        8,344        19,344 
 
Operating expenses:                 
     Research and development        12,480        10,332 
     General and administrative        4,570        4,424 
     Amortization of intangible assets        245        245 




Total operating expenses        17,295        15,001 




 
Loss from operations        (8,951)        4,343 
 
Interest income        2        110 
Interest expense        (399)        (15) 
Other income (expense)        164        (346) 




 
Net income (loss)        (9,184)        4,092 
 
Add: Losses attributed to noncontrolling interest in SDI                1,009 




 
Net income (loss) attributable to Dynavax       $    (9,184)                   $    5,101 


 
Basic and diluted net income (loss) per share attributable to                 
Dynavax common stockholders       $    (0.17)                   $    0.13 
 
Shares used to compute basic net income (loss) per share                 
 attributable to Dynavax common stockholders        54,364        39,889 
 
 
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DYNAVAX TECHNOLOGIES CORPORATION

RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES (In thousands) (Unaudited)

        Three Months Ended 
        March 31,     
        2010        2009 
 
GAAP revenues    $    8,344    $    19,344 
ADD:                 
Collaboration funding incurred under SDI programs                747 
LESS:                 
Non-cash deferred revenue from Merck collaboration                15,537 


Pro forma revenues (1)    $    8,344    $    4,554 





(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 
        March 31, 
    2010    2009 
 
GAAP operating expenses    $ 17,295    $ 15,001 
LESS:         
Stock-based compensation expense    541    519 
Amortization of intangible assets    245    245 


Pro forma operating expenses (2)    $ 16,509    $ 14,237 

(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)
 
        March 31,    December 31, 
             2010        2009 
Assets                 
 Cash and cash equivalents and marketable securities    $    30,080    $    36,720 
 Property and equipment, net        7,199        7,997 
 Goodwill        2,312        2,312 
 Other intangible assets, net        1,034        1,279 
 Other assets        3,659        2,162 




Total assets    $    44,284    $    50,470 




 
Liabilities and stockholders’ equity                 
 Accounts payable    $    1,091    $    1,686 
 Accrued liabilities        10,571        7,507 
 Warrant liability to Holdings        2,315        2,567 
 Current portion of deferred revenue        2,384        2,718 
 Noncurrent portion of deferred revenue        16,726        17,083 
 Long-term note payable to Holdings        9,741        9,342 
 Long-term contingent liability to Holdings        3,109        3,040 
 Other long-term liabilities        146        151 
 Stockholders’ equity (deficit)        (1,799)        6,376 




Total liabilities and stockholders’ equity    $    44,284    $    50,470 





# # #


August __, 2009

May 6, 2010

Dynavax Technologies Corporation

2929 Seventh Street, Suite 100

Berkeley, CA 94710

RE: Dynavax Technologies Corporation

Ladies and Gentlemen:

You have requested our opinion with respect to certain matters in connection with the sale by Dynavax Technologies Corporation (the "Company") of 800,860 shares of the Company's Common Stock (the "Shares") under the Equity Distribution Agreement dated as of August 17, 2009 by and between the Company and Wedbush Morgan Securities, Inc. (the "Agreement").

In connection with this opinion, we have examined and relied upon the representations and warranties as to factual matters contained in and made pursuant to the Agreement by the various parties and originals or copies certified to our satisfaction, of such records, documents, certificates, opinions, memoranda and other instruments as in our judgment are necessary or appropriate to enable us to render the opinion expressed below.

In rendering this opinion, we have assumed: the genuineness and authenticity of all signatures on original documents; the authenticity of all documents submitted to us as originals; the conformity to originals of all documents submitted to us as copies; the accuracy, completeness and authenticity of certificates of public officials; and the due authorization, execution and delivery of all documents, where authorization, execution and delivery are prerequisites to the effectiveness of such documents. We have also assumed that all individuals executing and delivering documents had the legal capacity to so execute and deliver.

On the basis of the foregoing, in reliance thereon and with the foregoing qualification, we are of the opinion that the Shares have been duly authorized and validly issued and are outstanding, fully paid and nonassessable.

Very truly yours,

 

Cooley llp

By: /s/ Glen Y. Sato

Glen Y. Sato