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):  05/06/2013
 
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, 2013, Dynavax Technologies Corporation ("Dynavax") issued a press release announcing its financial results for the first quarter ended March 31, 2013. 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 "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. The following exhibit is furnished herewith:

99.1 Press Release, dated May 6, 2013 titled "Dynavax Reports First Quarter 2013 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, 2013
     
By:
 
/s/    Michael S. Ostrach

               
Michael S. Ostrach
               
Vice President and Chief Business Officer
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-99.1
  
DYNAVAX REPORTS FIRST QUARTER 2013 FINANCIAL RESULTS
Contacts:

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 REPORTS FIRST QUARTER 2013 FINANCIAL RESULTS

BERKELEY, CA - May 6, 2013 - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the first quarter ended March 31, 2013. The Company had $105.4 million in cash, cash equivalents and marketable securities as of March 31, 2013. This compared to $125.1 million at December 31, 2012.

For the quarter ended March 31, 2013, Dynavax reported total revenues of $2.1 million compared to $2.4 million for the quarter ended March 31, 2012. Grant revenue from the Company's contract for adjuvant development awarded by the National Institutes of Health declined by $0.4 million from the prior year.

Research and development expenses for the quarter ended March 31, 2013 of $14.2 million increased by $1.8 million from the first quarter of 2012. This increase was due primarily to the purchase of a HEPLISAVTM component as well as severance expenses, including non-cash stock-based compensation charges.

General and administrative expenses for the quarter ended March 31, 2013 of $8.8 million increased by $3.0 million from the first quarter of 2012. This increase resulted primarily from incremental severance expenses, including non-cash stock-based compensation charges.

 

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine for which US and European licensure applications have been accepted for review by the FDA and the EMA. Dynavax plans to meet with the FDA in June to discuss the most expeditious path to approval for HEPLISAV, following the Complete Response Letter issued in February 2013. Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.

Forward-Looking Statements

This press release contains "forward-looking" statements. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including our meeting and plans for discussions with the FDA; whether successful clinical and regulatory development and review and approval of HEPLISAV and our process for its manufacture can occur without significant delay or additional studies; whether our studies and manufacturing efforts 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, including whether the BLA and the European licensure application will be approved; our ability to obtain additional financing to support the development and commercialization of HEPLISAV and our other operations; possible claims against us, including enjoining sales of HEPLISAV, 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 our 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,

2013

2012

Revenues:

Collaboration revenue

$ 883

$ 929

Grant revenue

760

1,087

Service and license revenue

442

334

Total revenues

2,085

2,350

Operating expenses:

Research and development

14,164

12,405

General and administrative

8,800

5,793

Total operating expenses

22,964

18,198

Loss from operations

(20,879)

(15,848)

Interest income

72

52

Interest expense

(32)

(587)

Other income (expense)

14

(122)

Net loss

$ (20,825)

$ (16,505)

Basic and diluted net loss per share

$ (0.11)

$ (0.11)

Shares used to compute basic and diluted net loss per share

182,847

155,431

 

 

DYNAVAX TECHNOLOGIES CORPORATION

SELECTED CONSOLIDATED BALANCE SHEET DATA

(In thousands)

(Unaudited)

March 31,

December 31,

2013

2012

Assets

   

Cash, cash equivalents and marketable securities

$ 105,373

$ 125,130

Property and equipment, net

7,972

7,965

Goodwill

2,400

2,475

Other assets

3,876

4,182

Total assets

$ 119,621

$ 139,752

     

Liabilities and stockholders' equity

Deferred revenues

$ 11,180

$ 12,068

Other liabilities

10,514

12,858

Total liabilities

21,694

24,926

Stockholders' equity

97,927

114,826

Total liabilities and stockholders' equity

$ 119,621

$ 139,752

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