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): February 13, 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 February 13, 2007, Dynavax Technologies Corporation issued a press release announcing its fiscal 2006 fourth quarter and year end 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 February 13, 2007 entitled “Dynavax Announces Fourth Quarter and Year End 2006 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.

INDEX TO EXHIBITS

Exhibit
Number		Description
99.1		Press release, dated February 13, 2007 entitled “Dynavax Announces Fourth Quarter and Year End 2006 Financial Results.”

Exhibit 99.1

		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 FOURTH QUARTER AND YEAR END
2006 FINANCIAL RESULTS

BERKELEY, Calif. — February 13, 2007 — Dynavax Technologies Corporation (Nasdaq: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2006.

As of December 31, 2006, Dynavax reported cash, cash equivalents, marketable securities and investments held by Symphony Dynamo, Inc. (SDI) totaling $86.2 million. This compares to $75.1 million at December 31, 2005.

“As we enter 2007, Dynavax has a strong cash position that together with our funds from existing partnerships and grants will allow us to advance our late-stage clinical product candidates as well as several important preclinical programs, including our universal influenza vaccine. Our fourth quarter cash represents a significantly strengthened position, primarily attributable to the approximately $44 million in net proceeds received from public offerings in the fourth quarter of 2006 that brought in a number of new well-known investors. In addition, we received a $10 million upfront payment in September 2006 from AstraZeneca, as part of the worldwide research and development collaboration in asthma and COPD. We also expect to add another $30 million in April 2007 representing the remaining funding commitment by SDI for Dynavax’s programs in cancer, hepatitis B and hepatitis C therapies,” said Dino Dina, MD, president and chief executive officer.

Total revenues were $2.4 million and $4.8 million, respectively, for the fourth quarter and year ended December 31, 2006, compared to $0.6 million and $14.7 million for the same periods in 2005. The reported revenues do not include collaboration funding from SDI of $4.4 million and $9.7 million, respectively, for the fourth quarter and year ended December 31, 2006. Revenues for the fourth quarter and full year 2006 include collaboration revenue from AstraZeneca, service and license revenue from customers of Dynavax Europe, and grant revenue primarily from the NIH. Revenues for full year 2005 reflected accelerated recognition of deferred revenue following the end of Dynavax’s collaboration with UCB Farchim.

- — more — -

Dynavax 4Q & YE 2006 Results
February 13, 2007
Page 2 of 5

Total operating expenses were $24.4 million and $69.8 million, respectively, for the fourth quarter and year ended December 31, 2006 compared to $10.1 million and $37.1 million for the same periods in 2005. Operating expenses included non-cash charges for stock-based compensation, as well as acquired in-process research and development and amortization of intangible assets resulting from the April 2006 Rhein acquisition. Excluding non-cash charges, pro forma operating expenses were $23.3 million and $61.7 million, respectively, for the fourth quarter and year ended December 31, 2006. The higher operating expenses for 2006 resulted primarily from increased clinical development activities related to the Company’s product candidates TOLAMBA™ and HEPLISAV™, the expansion of the Company’s operations to include Dynavax Europe, and reimbursable expenses related to SDI programs.

Net loss for the fourth quarter 2006 was $16.5 million, or $0.44 per share, compared to a net loss of $8.8 million, or $0.30 per share for the same period in 2005. Net loss for the year ended December 31, 2006 was $52.1 million, or $1.61 per share, compared to a net loss of $20.6 million, or $0.79 per share for the same period in 2005. The increase in net loss for 2006 was due primarily to increased clinical development expenditures on the Company’s lead product candidates as well as lower revenues following the termination of the UCB Farchim collaboration in 2005. 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.

Guidance for 2007 will be communicated after the company’s assessment of the recently reported one-year data analysis from its DARTT ragweed allergy trial is completed.

About Dynavax

Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent allergies, infectious diseases, 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 pipeline includes: HEPLISAV™, a hepatitis B vaccine in Phase 3; TOLAMBA™, a ragweed allergy immunotherapy; a therapy for non-Hodgkin’s lymphoma (NHL) in Phase 2; and a therapy for metastatic colorectal cancer in Phase 1. Our preclinical asthma and COPD programs are partnered with AstraZeneca. NIH funds our preclinical work on a vaccine for influenza; Symphony Dynamo, Inc., funds our colorectal cancer trial and our preclinical programs in hepatitis B and C therapies. While the NIH and Symphony 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.

This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about our product candidates and 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; 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 Annual Report on Form 10-K and 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.

— more —

Dynavax 4Q & YE 2006 Results
February 13, 2007
Page 3 of 5

DYNAVAX TECHNOLOGIES CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)

		Three Months Ended								Years Ended
		December 31,								December 31,
		2006				2005				2006				2005
Revenues:
Collaboration revenue		$	1,391			$	—			$	1,557			$	12,199
Service and license revenue			825				—				1,741				—
Grant revenue			222				600				1,549				2,456
Total revenues			2,438				600				4,847				14,655
Operating expenses:
Research and development (2)			19,981				7,942				50,116				27,887
General and administrative (3)			4,197				2,126				14,836				9,258
Acquired in-process research and development			—				—				4,180				—
Amortization of intangible assets			251				—				698				—
Total operating expenses (1)			24,429				10,068				69,830				37,145
Loss from operations			(21,991	)			(9,468	)			(64,983	)			(22,490	)
Interest and other income, net			1,095				706				3,188				1,935
Loss including noncontrolling interest in Symphony Dynamo, Inc.			(20,896	)			(8,762	)			(61,795	)			(20,555	)
Amount attributed to noncontrolling interest in Symphony Dynamo, Inc.			4,441				—				9,743				—
Net loss		$	(16,455	)		$	(8,762	)		$	(52,052	)		$	(20,555	)
Basic and diluted net loss per share		$	(0.44	)		$	(0.30	)		$	(1.61	)		$	(0.79	)
Shares used to compute basic and diluted net loss per share			37,645				29,398				32,339				25,914

— more —

Dynavax 4Q & YE 2006 Results
February 13, 2007
Page 4 of 5

DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES
(In thousands)
(Unaudited)

		Three Months Ended								Years Ended
		December 31,								December 31,
		2006				2005				2006				2005
GAAP revenues		$	2,438			$	600			$	4,847			$	14,655
ADD:
Collaboration funding incurred under SDI programs			4,414				—				9,702				—
Pro forma revenues (1)		$	6,852			$	600			$	14,549			$	14,655

DYNAVAX TECHNOLOGIES CORPORATION
RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES
(In thousands)
(Unaudited)

		Three Months Ended								Years Ended
		December 31,								December 31,
		2006				2005				2006				2005
GAAP operating expenses		$	24,429			$	10,068			$	69,830			$	37,145
LESS:
Stock-based compensation expense			917				439				3,283				1,400
Acquired in-process research and development			—				—				4,180				—
Amortization of intangible assets			251				—				698				—
Pro forma operating expenses		$	23,261			$	9,629			$	61,669			$	35,745

— more —

Dynavax 4Q & YE 2006 Results
February 13, 2007
Page 5 of 5

DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)

		December 31,
		2006				2005
Assets
Cash and cash equivalents and marketable securities (1)		$	86,194			$	75,110
Property and equipment, net			5,200				2,197
Goodwill			2,312				—
Other intangible assets, net			4,382				—
Other assets			4,802				2,786
Total assets		$	102,890			$	80,093
Liabilities, noncontrolling interest and stockholders’ equity
Current liabilities		$	13,701			$	5,543
Deferred revenue and other long-term liabilities			10,117				187
Noncontrolling interest in Symphony Dynamo, Inc.			2,016				—
Stockholders’ equity			77,056				74,363
Total liabilities, noncontrolling interest and stockholders’ equity		$	102,890			$	80,093

# # #