Dynavax Announces Second Quarter 2009 Financial Results
BERKELEY, Calif., Aug 04, 2009 (BUSINESS WIRE) -- 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 HEPLISAVTM, 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 TOLAMBATM 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.
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.
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.
DYNAVAX TECHNOLOGIES CORPORATION | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
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. | |||||||||||||||||
DYNAVAX TECHNOLOGIES CORPORATION | ||||||||||||
Three Months Ended | Six Months Ended | |||||||||||
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. | ||||||||||||
DYNAVAX TECHNOLOGIES CORPORATION | ||||||||||||
Three Months Ended | Six Months Ended | |||||||||||
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 | ||||
(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 | ||||||
| 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. | ||||||
SOURCE: Dynavax Technologies Corporation
Dynavax Technologies Corporation
Deborah A. Smeltzer, 510-665-7222
VP Operations &
Chief Financial Officer
dsmeltzer@dynavax.com
Amy Figueroa, 510-665-7211
Investor Relations &
Corporate Communications
afigueroa@dynavax.com
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