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):  03/02/2009
 
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 March 2, 2009, Dynavax Technologies Corporation (Dynavax) issued a press release announcing its financial results for fourth quarter and year ended December 31, 2008, and provided its 2009 financial outlook. 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 Technologies Corporation, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 
 
Item 8.01.    Other Events
 
On March 2, 2009, Dynavax provided a corporate update on certain clinical development programs as follows:

Corporate Update

Phase 3 HEPLISAVTM hepatitis B vaccine - Dynavax is seeking clarification of the remaining regulatory requirements for development and licensure of HEPLISAV in the United States and Europe and expects to have sufficient information in the first half of 2009 to determine a path forward, if any. Concurrently, Dynavax is pursing potential pharmaceutical partnerships and financing arrangements to complete clinical development if the regulatory feedback is positive. Dynavax also expects to report complete Phase 3 PHAST clinical study data from healthy adults in the second quarter of 2009.

Phase 1b SD-101 hepatitis C therapy - In mid-year 2009, Dynavax expects to report top-line data from an ongoing Phase 1b trial for SD-101 therapy for hepatitis C virus (HCV). This trial is being funded entirely under the Symphony Dynamo Inc. (SDI) arrangement.

Phase 1b DV-601 hepatitis B therapy - In mid-year 2009, Dynavax expects to begin enrolling patients in a Phase 1b trial for DV-601 therapy for hepatitis B virus (HBV).

Phase 1a studies - In the second half of 2009, Dynavax expects phase 1a studies will be initiated for AZD1419 for asthma, under a partnership with AstraZeneca, and DV1079 for autoimmune and inflammatory diseases, under a partnership with GlaxoSmithKline. In the first half of 2010, the Company plans to initiate a Phase 1a study for its Universal Flu vaccine, which is under a supply and option agreement with Novartis.

The foregoing "forward looking statements", are subject to a number of risks and uncertainties, including statements related to the nature and timing of communications with the FDA regarding the current HEPLISAV clinical hold and the potential for further development of this product, and planned initiation and completion of other clinical trials. Actual results may differ materially from those set forth in this r eport due to the risks and uncertainties inherent in our business and we undertake no obligation to update this information.
 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibits
Exhibit No.    Description
99.1             Press Release, dated March 2, 2009 titled "Dynavax Announces Fourth Quarter and Year-End 2008 Financial Results."
 

 

Signature(s)
 
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 02, 2009
     
By:
 
/s/    Deborah A. Smeltzer

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


 

Exhibit Index
 
Exhibit No.

  
Description

EX-99.1
  
Press Release, dated March 2, 2009 titled "Dynavax Announces Fourth Quarter and Year-End 2008 Financial Results."
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 FOURTH QUARTER AND YEAR-END 2008 FINANCIAL RESULTS

- Provides Corporate Update and 2009 Financial Outlook -

BERKELEY, Calif. - March 2, 2009 - Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2008 and provided a corporate update and financial outlook for 2009.

"We are making progress in our discussions with the regulatory authorities in the United States and Europe regarding the development of HEPLISAV(TM), our Phase 3 hepatitis B vaccine that has demonstrated significant clinical benefits based on our trials," commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "Our pharmaceutical partnerships, funding agreements, and stringent management of our cash provide Dynavax with the resources to reach several value inflection points for our diversified pipeline of products over the next 12 to 24 months."

Dynavax reported $68.5 million in cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc. (SDI), cumulatively referred to as total cash, at December 31, 2008. This compared to $64.3 million at September 30, 2008 and $88.2 million at December 31, 2007. Total cash at December 31, 2008 included an initial payment of $10 million from GlaxoSmithKline as part of a worldwide strategic alliance.

Total revenues were $11.9 million for the fourth quarter 2008, compared to $9.3 million for the fourth quarter 2007. Total revenues were $37.1 million for the year ended December 31, 2008, compared to $14.1 million for the same period of 2007. The significant increase in revenues for the fourth quarter and full year 2008 primarily was attributable to research and development funding for HEPLISAV and to a lesser extent the recognition of non-cash deferred revenue following the December 2008 termination of the Merck & Co., Inc. collaboration for HEPLISAV.

On a pro forma basis, including collaboration funding from SDI, revenues were $12.7 million for the fourth quarter 2008, compared to $11.4 million for the fourth quarter 2007, and $42.4 million for the full year 2008, compared to $24.7 million for the full year 2007.

Total operating expenses were $10.1 million for the fourth quarter 2008, compared to $23.3 million for the fourth quarter 2007. Total operating expenses were $61.2 million for the year ended December 31, 2008, compared to $85.2 million for the same period of

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2007. The decrease in operating expenses for the fourth quarter and full year 2008 was

primarily due to a reduction in clinical development costs associated with HEPLISAV and the discontinuation of clinical development for the TOLAMBA ragweed allergy program.

Total operating expenses for 2007 also included a one-time payment for a license to certain patent rights for the commercialization of HEPLISAV.

On a pro forma basis, excluding the one-time and other non-cash charges for stock-based compensation and amortization of intangible assets, operating expenses were $9.1 million for the fourth quarter 2008, compared to $22.0 million for the fourth quarter 2007, and $57.0 million for the full year 2008, compared to $75.7 million for the full year 2007.

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 income was $3.1 million, or $0.08 per share, for the fourth quarter 2008, compared to a net loss of $12.1 million, or $0.30 per share, for the fourth quarter 2007. Net loss for the year ended December 31, 2008 was $20.8 million, or $0.52 per share, compared to a net loss of $60.0 million, or $1.51 per share, for the same period of 2007. The net income for the fourth quarter and improvement in net loss for the full year 2008 reflected the increase in revenues from the Company's collaboration agreements and decrease in operating expenses. The net income for the fourth quarter 2008 is due to revenue recognized from non-recurring events and Dynavax does not expect to report quarterly net income during 2009.

Corporate Update

Phase 3 HEPLISAV hepatitis B vaccine - Dynavax is seeking clarification of the remaining regulatory requirements for development and licensure of HEPLISAV in the United States and Europe and expects to have sufficient information in the first half of 2009 to determine a path forward, if any. Concurrently, Dynavax is pursing potential pharmaceutical partnerships and financing arrangements to complete clinical development if the regulatory feedback is positive. Dynavax also expects to report complete Phase 3 PHAST clinical study data from healthy adults in the second quarter of 2009.

Phase 1b SD-101 hepatitis C therapy - In mid-year 2009, Dynavax expects to report top-line data from an ongoing Phase 1b trial for SD-101 therapy for hepatitis C virus (HCV). This trial is being funded entirely under the SDI arrangement.

Phase 1b DV-601 hepatitis B therapy - In mid-year 2009, Dynavax expects to begin enrolling patients in a Phase 1b trial for DV-601 therapy for hepatitis B virus (HBV).

Phase 1a studies - In the second half of 2009, Dynavax expects phase 1a studies will be initiated for AZD1419 for asthma, under a partnership with AstraZeneca, and DV1079 for autoimmune and inflammatory diseases, under a partnership with GlaxoSmithKline. In the first half of 2010, the Company plans to initiate a Phase 1a study for its Universal Flu vaccine, which is under a supply and option agreement with Novartis.

 

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2009 Financial Outlook

The following statements are forward-looking and are based on current expectations as of the date of this press release. Actual results may differ materially and Dynavax undertakes no duty to update these statements.

The Company's total cash is projected to be approximately $50 million at December 31, 2009, compared to $68.5 million at December 31, 2008. These projections do not include the potential impact of any new collaborations or other transactions that may be closed or entered into after March 2, 2009.

Total pro forma revenues for 2009 are expected to be in the range of $48 to $56 million, compared to $42.6 million for 2008. The pro forma revenues for 2009 include approximately $28 million of non-cash deferred revenue to be recognized following the termination of the HEPLISAV collaboration.

Total pro forma operating expenses for 2009 are projected to be in the range of $52 to $60 million, compared to $57.0 million for 2008.

About Dynavax

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax's proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca AB, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. 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 the current HEPLISAV clinical hold, planned initiation and completion of other clinical trials, and our projected cash position and operating results. 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 the provision of additional information requested by the FDA is found to be satisfactory, whether HEPLISAV can be further developed, or even if further development is permitted, that successful clinical development can occur in a timely manner or without significant additional studies and difficulties or delays in development, initiation and completion of clinical trials of our 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; obtaining regulatory approval for HEPLISAV; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K and 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 TECHNOLOGIES CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

Three Months Ended

December 31,

Year Ended

December 31,

2008

2007

2008

2007

Revenues:

Collaboration revenue

$ 10,231

$ 7,097

$ 31,666

$ 9,315

Grant revenue

972

1,198

2,999

3,046

Service and license revenue

742

1,000

2,429

1,732

Total revenues

11,945

9,295

37,094

14,093

Operating expenses:

Research and development (1)

6,249

18,183

44,771

65,888

General and administrative (2)

3,559

4,879

15,463

18,293

Amortization of intangible assets

245

250

980

1,004

Total operating expenses (3)

10,053

23,312

61,214

85,185

Income (loss) from operations

1,892

(14,017)

(24,120)

(71,092)

Interest and other income, net

284

1,571

1,741

4,165

Loan forgiveness

-

-

5,000

-

Interest expense

(16)

(1,631)

(9,157)

(1,719)

Income (loss) including noncontrolling interest in SDI.

2,160

(14,077)

(26,536)

(68,646)

Amount attributed to noncontrolling interest in SDI

939

2,001

5,707

8,675

Net income (loss)

$ 3,099

$ (12,076)

$ (20,829)

$ (59,971)

Basic and diluted net income (loss) per share

$ 0.08

$ (0.30)

$ (0.52)

$ (1.51)

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

39,854

39,765

39,819

39,746

  1. Research and development expenses included non-cash stock-based compensation charges of $0.4 million and $1.4 million for the fourth quarter and year ended December 31, 2008, respectively. Research and development expenses included non-cash stock-based compensation charges of $0.3 million and $1.1 million for the fourth quarter and year ended December 31, 2007, respectively.
  2. General and administrative expenses included non-cash stock-based compensation charges of $0.4 million and $1.8 million for the fourth quarter and year ended December 31, 2008, respectively. General and administrative expenses included non-cash stock-based compensation charges of $0.7 million and $2.4 million for the fourth quarter and year ended December 31, 2007, respectively.
  3. Total operating expenses excluding non-cash stock-based compensation charges were $9.3 million and $58.0 million for the fourth quarter and year ended December 31, 2008, respectively. Total operating expenses excluding non-cash stock-based compensation charges were $22.3 million and $81.7 million for the fourth quarter and year ended December 31, 2007, respectively.

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DYNAVAX TECHNOLOGIES CORPORATION

RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES

(In thousands)

(Unaudited)

Three Months Ended

December 31,

Year Ended

December 31,

2008

2007

2008

2007

GAAP revenues

$ 11,945

$ 9,295

$ 37,094

$ 14,093

ADD:

Collaboration funding incurred under SDI programs

744

2,115

5,349

10,602

Pro forma revenues (1)

$ 12,689

$ 11,410

$ 42,443

$ 24,695

  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.
  2.  

    DYNAVAX TECHNOLOGIES CORPORATION

    RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES

    (In thousands)

    (Unaudited)

    Three Months Ended

    December 31,

    Year Ended

    December 31,

    2008

    2007

    2008

    2007

    GAAP operating expenses

    $ 10,053

    $ 23,312

    $61,214

    $85,185

    LESS:

    Licensing fee

    -

    -

    -

    5,000

    Stock-based compensation expense

    717

    1,050

    3,205

    3,531

    Amortization of intangible assets

    245

    250

    980

    1,004

    Pro forma operating expenses (2)

    $ 9,091

    $ 22,012

    $ 57,029

    $ 75,650

  3. These pro forma amounts are intended to illustrate the company's operating expenses excluding certain one-time and 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.

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DYNAVAX TECHNOLOGIES CORPORATION

SELECTED BALANCE SHEET DATA

(In thousands)

December 31,

December 31,

2008

2007

Assets

(unaudited)

(audited)

Cash and cash equivalents and marketable securities (1)

$ 68,476

$ 88,248

Property and equipment, net

9,510

7,314

Goodwill

2,312

2,312

Other intangible assets, net

2,259

3,239

Other assets

8,066

19,336

Total assets

$ 90,623

$ 120,449

     

Liabilities, noncontrolling interest and stockholders' equity

Accounts payable

$ 905

$ 4,418

Accrued liabilities

6,816

12,059

Current portion of deferred revenue

33,133

3,427

Noncurrent portion of deferred revenue

18,512

40,792

Liability from Program Option exercised under the SDI collaboration

15,000

15,000

Other long-term liabilities

101

5,622

Noncontrolling interest in SDI

2,634

8,341

Stockholders' equity

13,522

30,790

Total liabilities, noncontrolling interest and stockholders' equity

$ 90,623

$ 120,449

  1. These amounts also include investments held by SDI of $25.1 million and $31.6 million as of December 31, 2008 and 2007, respectively.

 

 

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