| Exhibit 99.1 |
| DYNAVAX |
| DYNAVAX TECHNOLOGIES 2929 Seventh Street, Suite 100 Berkeley, CA 94710 |
| Contact: Jennifer Lew Vice President, Finance 510-665-7217 jlew@dynavax.com |
DYNAVAX REPORTS 2010 FIRST QUARTER FINANCIAL RESULTS
Conference Call and Webcast Today at 4:30 pm EDT
BERKELEY, CA – May 6, 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 HEPLISAVTM, 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 topro 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 athttp://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.
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| 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 visitwww.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 | ||||||
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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 formarevenues(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 formaoperating 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. |
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| 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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