Dynavax Technologies Corporation Reports 2010 First Quarter Financial Results

BERKELEY, CA--(Marketwire - May 06, 2010) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the first quarter ended March 31, 2010, including $30.1 million in cash and cash equivalents. Total cash for the first quarter 2010 does not include $41 million in net proceeds from the public offering completed on April 16, 2010.

“With the completion of the recent financing, we are poised to achieve our most critical goals, including completion of the Phase 3 study required for submitting our BLA for HEPLISAV™, initiating clinical development for our Universal Flu and TLR autoimmune products, and positioning hepatitis B and C therapeutics for out-licensing,” noted Dino Dina, M.D., President and CEO.

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.

Conference Call

Dynavax will webcast a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT). 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 HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS 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 diseases. The Company’s lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed 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 relating to clinical trials and BLA submission. 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 successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies 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; the Company’s ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, 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. 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 March 31, -------------------- 2010 2009 --------- --------- Revenues: Collaboration revenue $ 7,421 $ 17,692 Grant revenue 862 1,139 Service and license revenue 61 513 --------- --------- Total revenues 8,344 19,344 Operating expenses: Research and development 12,480 10,332 General and administrative 4,570 4,424 Amortization of intangible assets 245 245 --------- --------- Total operating expenses 17,295 15,001 --------- --------- Loss from operations (8,951) 4,343 Interest income 2 110 Interest expense (399) (15) Other income (expense) 164 (346) --------- --------- Net income (loss) (9,184) 4,092 Add: Losses attributed to noncontrolling interest in SDI -- 1,009 --------- --------- Net income (loss) attributable to Dynavax $ (9,184) $ 5,101 ========= ========= Basic and diluted net income (loss) per share attributable to Dynavax common stockholders $ (0.17) $ 0.13 ========= ========= Shares used to compute basic net income (loss) per share attributable to Dynavax common stockholders 54,364 39,889 ========= ========= DYNAVAX TECHNOLOGIES CORPORATION RECONCILIATION OF GAAP REVENUES TO PRO FORMA REVENUES (In thousands) (Unaudited) Three Months Ended March 31, --------------------- 2010 2009 ---------- ---------- GAAP revenues $ 8,344 $ 19,344 ADD: Collaboration funding incurred under SDI programs -- 747 LESS: Non-cash deferred revenue from Merck collaboration -- 15,537 ---------- ---------- Pro forma revenues(1) $ 8,344 $ 4,554 ========== ========== (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. DYNAVAX TECHNOLOGIES CORPORATION RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES (In thousands) (Unaudited) Three Months Ended March 31, --------------------- 2010 2009 ---------- ---------- GAAP operating expenses $ 17,295 $ 15,001 LESS: Stock-based compensation expense 541 519 Amortization of intangible assets 245 245 ---------- ---------- Pro forma operating expenses(2) $ 16,509 $ 14,237 ========== ========== (2) 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. DYNAVAX TECHNOLOGIES CORPORATION SELECTED BALANCE SHEET DATA (In thousands) (Unaudited) March 31, December 31, 2010 2009 ----------- ------------ Assets Cash and cash equivalents and marketable securities $ 30,080 $ 36,720 Property and equipment, net 7,199 7,997 Goodwill 2,312 2,312 Other intangible assets, net 1,034 1,279 Other assets 3,659 2,162 ----------- ------------ Total assets $ 44,284 $ 50,470 =========== ============ Liabilities and stockholders’ equity Accounts payable $ 1,091 $ 1,686 Accrued liabilities 10,571 7,507 Warrant liability to Holdings 2,315 2,567 Current portion of deferred revenue 2,384 2,718 Noncurrent portion of deferred revenue 16,726 17,083 Long-term note payable to Holdings 9,741 9,342 Long-term contingent liability to Holdings 3,109 3,040 Other long-term liabilities 146 151 Stockholders’ equity (deficit) (1,799) 6,376 ----------- ------------ Total liabilities and stockholders’ equity $ 44,284 $ 50,470 =========== ============ 


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Jennifer Lew
Vice President, Finance
510-665-7217
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