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):  08/04/2009
 
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 August 4, 2009, Dynavax Technologies Corporation ("Dynavax"), issued a press release announcing its financial results for second quarter ended June 30, 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 August 4, 2009, Dynavax issued a press release titled "Dynavax Announces Path for HEPLISAV(TM)Hepatitis B Vaccine Development." 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) Exhibits

Exhibit No.    Description

99.1             Press Release, dated August 4, 2009 titled "Dynavax Announces Second Quarter 2009 Financial Results."

99.2             Press Release, dated August 4, 2009 titled "Dynavax Announces Path for HEPLISAV(TM) Hepatitis B Vaccine Development."

 

 

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: August 04, 2009
     
By:
 
/s/    Deborah A. Smeltzer

               
Deborah A. Smeltzer
               
Vice President, Operations & Chief Financial Officer
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-99.1
  
Press Release, dated August 4, 2009 titled "Dynavax Announces Second Quarter 2009 Financial Results."
EX-99.2
  
Press Release, dated August 4, 2009 titled "Dynavax Announces Path for HEPLISAV(TM) Hepatitis B Vaccine Development."
UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Exhibit 99.1

DYNAVAX

DYNAVAX TECHNOLOGIES

2929 Seventh Street, Suite 100 Berkeley, CA 94710

Contacts:

   

Deborah A. Smeltzer

 

Amy Figueroa

VP Operations &

Chief Financial Officer

Investor Relations & Corporate Communications

510-665-7222

510-665-7211

dsmeltzer@dynavax.com

afigueroa@dynavax.com

 

DYNAVAX ANNOUNCES SECOND QUARTER 2009 FINANCIAL RESULTS

BERKELEY, Calif. - August 4, 2009 - Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the second quarter and six months ended June 30, 2009.

Dynavax reported $53.0 million in cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc. (SDI), collectively referred to as total cash, at June 30, 2009. This compared to $60.5 million at March 31, 2009.

Total revenues for the second quarter 2009 were $15.9 million, compared to $10.0 million reported for the second quarter in 2008. Total revenues were $35.2 million for the six months ended June 30, 2009, compared to $16.3 million for the same period in 2008. The significant increase in revenues for the second quarter and six months ended June 30, 2009 was primarily attributable to the recognition of $12.9 million and $28.5 million, respectively, of non-cash deferred revenue that was accelerated following the announcement of the termination of the Merck & Co., Inc. collaboration for HEPLISAV(TM), Dynavax's investigational hepatitis B vaccine. The Company completed the recognition of the non-cash deferred revenue relating to the HEPLISAV collaboration in the second quarter 2009.

On a pro forma basis, including collaboration funding from SDI and excluding the non-cash deferred revenue from the Merck collaboration, revenues were $3.7 million and $8.3 million, respectively, for the second quarter and six months ended June 30, 2009, compared to $10.8 million and $18.0 million for the same period in 2008.

Total operating expenses were $13.0 million for the second quarter 2009, compared to $16.6 million for the second quarter 2008. Total operating expenses were $28.0 million for the six months ended June 30, 2009, compared to $36.5 million for the same period in 2008. The decrease in operating expenses for 2009 was primarily due to a reduction in clinical development costs associated with HEPLISAV and the discontinuation of development for the TOLAMBA(TM) ragweed allergy program in May 2008.

On a pro forma basis, excluding the non-cash charges for stock-based compensation and amortization of intangible assets, operating expenses were $12.1 million and $26.3 million, respectively, for the second quarter and six months ended June 30, 2009, compared to $15.6 million and $34.6 million for the same periods in 2008.

- more -

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.

The net income of $4.1 million, or $0.10 per share, reported for the second quarter 2009 improved from the net loss of $6.1 million, or $0.15 per share, for the same period in 2008. The net income of $9.2 million, or $0.23 per share, reported for the six months ended June 30, 2009 was also significantly improved compared to the net loss of $18.5 million, or $0.47 per share, for the same period in 2008. The improvement in net loss for 2009 is due to the recognition of non-cash deferred revenue and a decrease in total operating expenses.

Program Update

Phase 3 HEPLISAV Hepatitis B Vaccine - As reported in a separate press release today, Dynavax has met with the U.S. Food and Drug Administration (FDA) to discuss its plans to resume clinical development for HEPLISAV.

Clinical-Stage Programs - Dynavax's clinical-stage programs include Phase 1b hepatitis C and hepatitis B therapies.

Hepatitis C Therapy - SD-101 is a second generation TLR-9 agonist being developed for hepatitis C and is entirely funded through the SDI agreement. Phase 1 studies have demonstrated SD-101's safety, tolerability, and antiviral activity and Dynavax is reviewing future development options with Symphony Capital.

Hepatitis B Therapy - DV-601 combines both surface and core HBV antigens and Dynavax is planning to initiate a Phase 1b clinical trial.

Preclinical Programs - Dynavax's preclinical programs include programs partnered with pharmaceutical partners AstraZeneca and GlaxoSmithKline and the Company's Universal Flu vaccine. The vaccine has demonstrated its biological mechanism in a flu model.

2009 Financial Outlook

Dynavax plans to provide its updated financial outlook for 2009 after determining the timing, scope, and funding for HEPLISAV's future development.

Conference Call

Dynavax will webcast a conference call today at 5:00 p.m. ET (2:00 p.m. PT). 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 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, a Phase 3 vaccine targeted for individuals who are less responsive to current licensed hepatitis B vaccines. For more information visit www.dynavax.com.

- more -

Forward Looking Statements

This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties. 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 and when the FDA will remove the clinical hold for HEPLISAV, whether HEPLISAV can be further developed, financed or commercialized, or even if further development is permitted, that successful clinical development and regulatory approval can occur in a timely manner or without significant additional studies and difficulties or delays in development; initiation and completion of clinical trials of the Company's other product candidates; 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 its operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of the Company's current periodic reports with the SEC. The Company undertakes 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

June 30,

Six Months Ended

June 30,

2009

2008

2009

2008

Revenues:

Collaboration revenue

$ 14,596

$ 7,701

$ 32,288

$ 13,475

Grant revenue

895

1,122

2,034

1,446

Service and license revenue

393

1,155

906

1,371

Total revenues

15,884

9,978

35,228

16,292

Operating expenses:

Research and development (1)

9,239

12,946

19,571

28,066

General and administrative (2)

3,533

3,420

7,957

7,991

Amortization of intangible assets

245

245

490

490

Total operating expenses (3)

13,017

16,611

28,018

36,547

Income (loss) from operations

2,867

(6,633)

7,210

(20,255)

Interest income

46

439

156

1,148

Interest expense

(12)

(1,340)

(27)

(2,684)

Other income (expense)

226

(34)

(120)

228

Net income (loss).

3,127

(7,568)

7,219

(21,563)

Add: Losses attributed to noncontrolling interest in SDI

983

1,489

1,992

3,055

Net income (loss) attributable to Dynavax

$ 4,110

$ (6,079)

$ 9,211

$ (18,508)

Basic net income (loss) per share

$ 0.10

$ (0.15)

$ 0.23

$ (0.47)

Shares used to compute basic net income (loss) per share

39,923

39,806

39,906

39,795

Diluted net income (loss) per share

$ 0.10

$ (0.15)

$ 0.23

$ (0.47)

Shares used to compute diluted net income (loss) per share

40,064

39,806

39,906

39,795

  1. Research and development expenses included non-cash stock-based compensation charges of $0.3 million and $0.4 million for the three and six months ended June 30, 2009, respectively. Research and development expenses included non-cash stock-based compensation charges of $0.4 million and $0.6 million for the three and six months ended June 30, 2008, respectively.
  2. General and administrative expenses included non-cash stock-based compensation charges of $0.3 million and $0.8 million for the three and six months ended June 30, 2009, respectively. General and administrative expenses included non-cash stock-based compensation charges of $0.4 million and $0.9 million for the three and six months ended June 30, 2008, respectively.
  3. Total operating expenses excluding non-cash stock-based compensation charges are $12.4 million and $26.8 million for the three and six months ended June 30, 2009, respectively. Total operating expenses excluding non-cash stock-based compensation charges are $15.8 million and $35.1 million for the three and six months ended June 30, 2008, respectively.

- more -

DYNAVAX TECHNOLOGIES CORPORATION

RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES

(In thousands)

(Unaudited)

Three Months Ended

June 30,

Six Months Ended

June 30,

2009

2008

2009

2008

GAAP revenues

$ 15,884

$ 9,978

$ 35,228

$ 16,292

ADD:

Collaboration funding incurred under SDI programs

795

1,432

1,542

2,963

LESS:

Non-cash deferred revenue from Merck collaboration

12,948

619

28,485

1,283

Pro forma revenues (1)

$ 3,731

$ 10,791

$ 8,285

$ 17,972

  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.
  2.  

    DYNAVAX TECHNOLOGIES CORPORATION

    RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES

    (In thousands)

    (Unaudited)

    Three Months Ended

    June 30,

    Six Months Ended

    June 30,

    2009

    2008

    2009

    2008

    GAAP operating expenses

    $ 13,017

    $ 16,611

    $ 28,018

    $ 36,547

    LESS:

    Stock-based compensation expense

    667

    775

    1,186

    1,436

    Amortization of intangible assets

    245

    245

    490

    490

    Pro forma operating expenses (2)

    $ 12,105

    $ 15,591

    $ 26,342

    $ 34,621

  3. 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)

June 30,

December 31,

2009

2008

Assets

(unaudited)

Cash and cash equivalents and marketable securities (1)

$ 53,040

$ 68,476

Property and equipment, net

8,610

9,510

Goodwill

2,312

2,312

Other intangible assets, net

1,769

2,259

Other assets

3,417

8,066

Total assets

$ 69,148

$ 90,623

     

Liabilities and stockholders' equity

Accounts payable

$ 1,222

$ 905

Accrued liabilities

6,682

6,816

Current portion of deferred revenue

3,672

33,133

Noncurrent portion of deferred revenue

17,798

18,512

Liability from Program Option exercised under the SDI collaboration

15,000

15,000

Other long-term liabilities

166

101

Stockholders' equity

24,608

16,156

Total liabilities and stockholders' equity

$ 69,148

$ 90,623

  1. These amounts also included investments held by SDI of $22.8 million and $25.1 million as of June 30, 2009 and December 31, 2008, respectively.

 

 

 

 

 

# # #

Exhibit 99.2

DYNAVAX

DYNAVAX TECHNOLOGIES

2929 Seventh Street, Suite 100 Berkeley, CA 94710

Amy Figueroa

Investor Relations and Corporate Communications

Phone: (510) 665-7211

Email: afigueroa@dynavax.com

DYNAVAX ANNOUNCES PATH FOR

HEPLISAVTM HEPATITIS B VACCINE DEVELOPMENT

BERKELEY, CA - August 4, 2009 - Dynavax Technologies Corporation (Nasdaq: DVAX) today announced it has met with the U.S. Food and Drug Administration (FDA) to discuss its plans to resume development of HEPLISAV(TM), the Company's Phase 3 investigational hepatitis B vaccine.

Dynavax proposed the continued clinical development of HEPLISAV in populations that are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and other groups such as individuals infected with HIV or diagnosed with chronic liver disease. The FDA expressed a general agreement that these populations are appropriate for further clinical development, pending the review of the study protocols and additional supportive data.

Dynavax plans to submit this information to the FDA in August 2009 with a goal of having the agency remove the clinical hold in September 2009. The Company is prepared to restart clinical trials in individuals with chronic kidney disease upon removal of the clinical hold.

About HEPLISAV

HEPLISAV is a Phase 3 investigational hepatitis B vaccine targeted for adults who are less responsive to current licensed hepatitis B vaccines, including adults over 40 years of age, individuals with chronic kidney disease (including end-stage renal disease, or ESRD, patients), and individuals infected with HIV or diagnosed with chronic liver disease (including hepatitis C virus).

Phase 3 data from the PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of HEPLISAV over one month achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six months. Over 2,500 individuals have been vaccinated with HEPLISAV to date.

Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

Hepatitis B Vaccines and Market Opportunity

Hepatitis B is a chronic disease which can lead to cirrhosis of the liver and hepatocellular carcinoma. There is no cure for hepatitis B and disease prevention through effective vaccination is critical to reducing the spread of the disease. The total worldwide market for adult hepatitis B vaccines is estimated at over $500 million annually.

- more -

ESRD Market - The ESRD market is large and growing rapidly. In the United States alone, there are approximately 500,000 ESRD patients and 100,000 new patients annually, with similar numbers in Europe. CDC recommends universal vaccination of ESRD patients. Since ESRD patients are less responsive to current vaccines, hepatitis B vaccination regimens for ESRD consist of 8 doses of Engerix-B(R) over six months (versus 3 doses for the general population). Many ESRD patients do not respond to vaccination and boosters or revaccination is recommended. As ESRD patients are vaccinated regularly at dialysis centers, this is a highly concentrated, renewable market that can be served by cost-effective, targeted sales distribution networks.

Other Markets - In addition to ESRD patients, other populations such as individuals infected with HIV or diagnosed with chronic liver disease are also less responsive to current hepatitis B vaccines and represent a large, poorly served market opportunity.

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, a Phase 3 vaccine targeted for individuals who are less responsive to current licensed hepatitis B 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 related to the nature and timing of communications with the FDA regarding HEPLISAV, submissions of documents, and potential clinical trials. 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 and when the FDA will remove the clinical hold on HEPLISAV, whether HEPLISAV can be further developed, financed or commercialized, or even if further development is permitted, that successful clinical development and regulatory approval can occur in a timely manner or without significant additional studies or difficulties or delays in development, the Company's ability to obtain additional financing to support its op erations, 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.

 

# # #

 

 

 

 

 

 

Engerix-B(R) is a licensed trademark of GlaxoSmithKline.