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):  03/01/2013
 
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 March 1, 2013, Dynavax Technologies Corporation ("Dynavax") issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2012. 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 March 1, 2013 titled "Dynavax Reports Fourth Quarter and Year End 2012 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: March 01, 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 FOURTH QUARTER AND YEAR END 2012 FINANCIAL RESULTS

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 FOURTH QUARTER AND YEAR END 2012

FINANCIAL RESULTS

BERKELEY, CA - March 1, 2013 - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2012. The Company had $125.1 million in cash, cash equivalents and marketable securities as of December 31, 2012, following the fourth quarter repayment of a $15 million note at its maturity and receipt of $6 million from AstraZeneca, Dynavax's collaboration partner for its asthma program.

For the quarter ended December 31, 2012, Dynavax reported total revenues of $1.8 million compared to $11.4 million for the quarter ended December 31, 2011. Collaboration revenue in the fourth quarter of 2011 was higher due to the recognition of certain milestones achieved under Dynavax's partnership with GlaxoSmithKline.

Research and development expenses for the quarter ended December 31, 2012 of $12.5 million increased by $0.9 million from the fourth quarter of 2011 resulting from growth in the organization associated with manufacturing and regulatory activities for HEPLISAVTM.

General and administrative expenses for the quarter ended December 31, 2012 of $9.3 million increased by $4.7 million primarily due to higher non-cash stock-based compensation charges of $2.4 million, as well as increased administrative headcount and market research costs supporting HEPLISAV.

For the year ended December 31, 2012, total revenues were $9.7 million compared to $21.6 million in 2011. Research and development expenses for the year ended December 31, 2012 of $49.1 million decreased by $2.2 million from the prior year resulting from lower HEPLISAV clinical trial expenses. General and administrative expenses for the year ended December 31, 2012 of $28.2 million increased by $10.6 million primarily due to market research expenses and other corporate development activities supporting HEPLISAV, growth in the organization, and increased non-cash stock-based compensation charges.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine for which U.S. and European licensure applications have been accepted for review by the FDA and the EMA. In February 2013, Dynavax received a Complete Response Letter from the FDA. Dynavax plans to meet with the FDA in the near term to discuss the steps necessary for potential approval of HEPLISAV. 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 ability to meet with the FDA in the near term; 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

December 31,

Years Ended

December 31,

2012

2011

2012

2011

Revenues:

Collaboration revenue

$ 1,008

$ 10,092

$ 4,610

$ 17,190

Grant revenue

751

673

3,939

3,110

Service and license revenue

47

662

1,165

1,314

Total revenues

1,806

11,427

9,714

21,614

Operating expenses:

Research and development

12,515

11,616

49,146

51,322

General and administrative

9,293

4,545

28,164

17,570

Amortization of intangible assets

-

-

-

299

Total operating expenses

21,808

16,161

77,310

69,191

Loss from operations

(20,002)

(4,734)

(67,596)

(47,577)

Interest income

83

29

291

103

Interest expense

(586)

(495)

(2,351)

(1,957)

Other income (expense)

(38)

933

(293)

834

Net loss

$ (20,543)

$ (4,267)

$ (69,949)

$ (48,597)

Basic and diluted net loss per share

$ (0.11)

$ (0.03)

$ (0.41)

$ (0.39)

Shares used to compute basic and diluted net loss per share

180,685

142,482

170,469

125,101

 

DYNAVAX TECHNOLOGIES CORPORATION

SELECTED BALANCE SHEET DATA

(In thousands)

(Unaudited)

December 31,

December 31,

2012

2011

Assets

   

Cash, cash equivalents and marketable securities

$ 125,130

$ 113,961

Property and equipment, net

7,965

6,163

Goodwill

2,475

2,312

Other assets

4,182

11,666

Total assets

$ 139,752

$ 134,102

     

Liabilities and stockholders' equity

Deferred revenues

$ 12,068

$ 10,596

Short-term note payable

-

12,810

Other liabilities

12,858

10,816

Total liabilities

24,926

34,222

Stockholders' equity

114,826

99,880

Total liabilities and stockholders' equity

$ 139,752

$ 134,102

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