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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
 
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES AND EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): July 31, 2007
DYNAVAX TECHNOLOGIES
CORPORATION
(Exact name of registrant as specified in charter)
         
Delaware
(State or other jurisdiction of
incorporation)
  000-50577
(Commission File Number)
  33-0728374
(I.R.S. Employer Identification
No.)
2929 Seventh Street, Suite 100
Berkeley, California 94710

(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (510) 848-5100
 
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:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   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 July 31, 2007, Dynavax Technologies Corporation issued a press release announcing its fiscal 2007 second quarter financial results. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
The information in this current report and in the 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.
(d) Exhibits.
     
Exhibit No.   Description
99.1
  Press release, dated July 31, 2007 entitled “Dynavax Announces Second Quarter 2007 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
 
 
Dated: August 1, 2007  By:   /s/ Michael Ostrach  
    Michael Ostrach, Vice President, Chief Business  
    Officer and General Counsel   

 


 

         
INDEX TO EXHIBITS
     
Exhibit    
Number   Description
 
   
99.1
  Press release, dated July 31, 2007 entitled “Dynavax Announces Second Quarter 2007 Financial Results.”

 

exv99w1
 

Exhibit 99.1
     
 
  (DYNAVAX LOGO)
 
  2929 Seventh Street, Suite 100
 
  Berkeley, CA 94710
Contact:
Dynavax Technologies Corporation
Deborah A. Smeltzer
VP Operations & Chief Financial Officer
Phone (510) 665-7222
Email: dsmeltzer@dynavax.com
DYNAVAX ANNOUNCES SECOND QUARTER 2007 FINANCIAL RESULTS
BERKELEY, Calif. — July 31, 2007 — Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the second quarter and six months ended June 30, 2007.
As of June 30, 2007, Dynavax reported cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc. (SDI) totaling $82.6 million. This compares to $86.2 million at December 31, 2006.
“Both of Dynavax’s advanced product candidates, HEPLISAV for the prevention of hepatitis B and TOLAMBA for the treatment of ragweed allergy, have progressed. With the expected completion of the pivotal HEPLISAV trial in Canada and in Europe, we have an opportunity to submit a BLA in 2008. The recently announced project financing from Deerfield Management for TOLAMBA provides us with the tools to design and implement studies that could, if successful, lead to a BLA submission. Clearly, these are accomplishments that underscore the broadly enabling product potential of our TLR9 agonist approach,” said Dino Dina, MD, president and chief executive officer.
Total revenues were $1.8 million and $3.8 million for the three and six months ended June 30, 2007, respectively, compared to $0.5 million and $0.8 million for the same periods in 2006. The increase in revenues resulted from our collaboration with AstraZeneca, service and license revenue from customers of Dynavax Europe, and grant revenue primarily from the NIH. The reported revenues do not include collaboration funding from SDI. Including the collaboration funding from SDI, pro forma revenues were $4.9 million and $10.4 million, respectively, for the three and six months ended June 30, 2007, compared to $2.5 million and $2.8 million for the same periods in 2006.
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Dynavax 2Q 2007 Results
July 31, 2007
Page 2 of 6
Total operating expenses were $23.6 million and $41.7 million for the three and six months ended June 30, 2007, respectively, compared to $18.5 million and $27.7 million for the same periods in 2006. The increase in operating expenses resulted primarily from increased clinical development and licensing activities related to the Company’s product candidate HEPLISAV™, the expansion of the Company’s operations to include Dynavax Europe, and reimbursable expenses related to SDI programs. Operating expenses include a one-time $5 million license payment for the commercialization of HEPLISAV™, and non-cash charges for stock-based compensation, acquired in-process research and development and amortization of intangible assets resulting from the April 2006 acquisition of Rhein Biotech GmbH (Dynavax Europe). Excluding one-time and non-cash charges, pro forma operating expenses were $17.7 million and $34.7 million, respectively, for the three and six months ended June 30, 2007, compared to $13.4 million and $21.9 million for the same periods in 2006.
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 loss for the second quarter 2007 was $17.7 million, or $0.45 per share, compared to a net loss of $15.3 million, or $0.50 per share, for the same period in 2006. Net loss for the six months of 2007 was $30.8 million, or $0.78 per share, compared to a net loss of $23.4 million, or $0.77 per share, for the same period in 2006. The increase in net loss was due primarily to increased clinical development expenditures on the Company’s product candidates and overall organizational growth. The increase in shares used to compute net loss per share resulted from the Company’s equity financing activities completed in the fourth quarter 2006.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Our product candidates include: HEPLISAV, a hepatitis B vaccine in Phase 3; TOLAMBA, a clinical ragweed allergy immunotherapy; a therapy for non-Hodgkin’s lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. Our preclinical work on a vaccine for influenza is partially funded by the NIH. Our colorectal cancer trial and our preclinical hepatitis C therapeutic program are funded by Symphony Dynamo, Inc. While the NIH and SDI provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit http://www.dynavax.com.
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Dynavax 2Q 2007 Results
July 31, 2007
Page 3 of 6
This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about planned clinical trials and BLA submissions for our product candidates HEPLISAV and TOLAMBA and our financial position. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in development and achieving our related timelines; achieving the objectives of our collaborative and licensing agreements such as our SDI and AstraZeneca arrangements; and obtaining regulatory approval for our products; the scope and validity of patent protection for our products; possible claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the “Risk Factors” section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
— Tables to follow —

 


 

Dynavax 2Q 2007 Results
July 31, 2007
Page 4 of 6
DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2007     2006     2007     2006  
 
                               
Revenues:
                               
Collaboration revenue
  $ 752     $     $ 1,499     $  
Service and license revenue
    461       224       570       224  
Grant revenue
    587       305       1,715       593  
 
                       
Total revenues
    1,800       529       3,784       817  
 
                               
Operating expenses:
                               
Research and development (2)
    19,164       10,762       32,796       17,354  
General and administrative (3)
    4,206       3,380       8,386       5,983  
Acquired in-process research and development
          4,180             4,180  
Amortization of intangible assets
    252       196       503       196  
 
                       
Total operating expenses (1)
    23,622       18,518       41,685       27,713  
 
                       
 
                               
Loss from operations
    (21,822 )     (17,989 )     (37,901 )     (26,896 )
 
                               
Interest and other income, net
    1,081       685       2,054       1,420  
 
                       
 
                               
Loss including noncontrolling interest in Symphony Dynamo, Inc
    (20,741 )     (17,304 )     (35,847 )     (25,476 )
 
                               
Amount attributed to noncontrolling interest in Symphony Dynamo, Inc
    3,037       2,031       5,053       2,031  
 
                       
 
                               
Net loss
  $ (17,704 )   $ (15,273 )   $ (30,794 )   $ (23,445 )
 
                       
 
                               
Basic and diluted net loss per share
  $ (0.45 )   $ (0.50 )   $ (0.78 )   $ (0.77 )
 
                       
Shares used to compute basic and diluted net loss per share
    39,741       30,536       39,734       30,524  
 
                       
 
(1)   Total operating expenses excluding non-cash stock-based compensation charges are $22.9 million and $40.2 million for the three and six months ended June 30, 2007, respectively. Total operating expenses excluding non-cash stock-based compensation charges are $17.8 million and $26.3 million for the three and six months ended June 30, 2006, respectively.
 
(2)   Research and development expenses included non-cash stock-based compensation charges of $0.3 million and $0.5 million for the three and six months ended June 30, 2007, respectively. Research and development expenses included non-cash stock-based compensation charges of $0.3 million and $0.6 million for the three and six months ended June 30, 2006, respectively.
 
(3)   General and administrative expenses included non-cash stock-based compensation charges of $0.4 million and $1.0 million for the three and six months ended June 30, 2007, respectively. General and administrative expenses included non-cash stock-based compensation charges of $0.5 million and $0.8 million for the three and six months ended June 30, 2006, respectively.
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Dynavax 2Q 2007 Results
July 31, 2007
Page 5 of 6
DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
(In thousands)
(Unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2007     2006     2007     2006  
GAAP revenues
  $ 1,800     $ 529     $ 3,784     $ 817  
 
                               
ADD:
                               
Collaboration funding incurred under SDI programs
    3,136       1,998       6,632       1,998  
 
                       
Pro forma revenues (1)
  $ 4,936     $ 2,527     $ 10,416     $ 2,815  
 
                       
 
(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     Six Months Ended  
    June 30,     June 30,  
    2007     2006     2007     2006  
GAAP operating expenses
  $ 23,622     $ 18,518     $ 41,685     $ 27,713  
LESS:
                               
Licensing fee
    5,000             5,000        
Stock-based compensation expense
    698       730       1,497       1,396  
Acquired in-process research and development
          4,180             4,180  
Amortization of intangible assets
    252       196       503       196  
 
                       
Pro forma operating expenses (2)
  $ 17,681     $ 13,412     $ 34,685     $ 21,941  
 
                       
 
(2)   These pro forma amounts are intended to illustrate the company’s operating expenses excluding certain non-cash charges in accordance with the financials 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 2Q 2007 Results
July 31, 2007
Page 6 of 6
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
                 
    June 30,     December 31,  
    2007     2006  
Assets
  (unaudited)        
Cash and cash equivalents and marketable securities (1)
  $ 82,578     $ 86,194  
Property and equipment, net
    6,040       5,200  
Goodwill
    2,312       2,312  
Other intangible assets, net
    3,879       4,382  
Other assets
    3,673       4,802  
 
           
Total assets
  $ 98,482     $ 102,890  
 
           
 
               
Liabilities, noncontrolling interest and stockholders’ equity
               
Current liabilities
  $ 13,589     $ 13,701  
Noncurrent portion of deferred revenue
    10,000       10,000  
Other long-term liabilities
    9,531       117  
Noncontrolling interest in Symphony Dynamo, Inc
    17,514       2,016  
Stockholders’ equity
    47,848       77,056  
 
           
Total liabilities, noncontrolling interest and stockholders’ equity
  $ 98,482     $ 102,890  
 
           
 
(1)   These amounts also include investments held by Symphony Dynamo, Inc. of $35.1 million as of June 30, 2007.
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