Full Press Release Details
BERKELEY, CA--(Marketwire - May 5, 2011) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the first quarter ended March 31, 2011, including $53.2 million in cash, cash equivalents and marketable securities at March 31, 2011. A $6 million milestone payment from GlaxoSmithKline earned after the close of the quarter from the initiation of a Phase 1 trial in the partnered lupus program was not included in the reported cash balance of $53.2 million. At December 31, 2010, Dynavax reported $72.2 million in total cash.
Total operating expenses for the quarter were in line with earlier expense guidance that full year 2011 expenses will be consistent with 2010. Net cash usage for the first quarter 2011 was higher than the average quarterly net cash usage during 2010, due to significant payments for the large-scale Phase 3 study of HEPLISAV™ which completes this month. The Company anticipates a reduction in ongoing quarterly spend through the remainder of 2011 such that its average quarterly net cash usage should approximate $13 million for 2011.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection 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 regarding our projected net cash usage and operating expenses. 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.
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| DYNAVAX TECHNOLOGIES CORPORATION | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (In thousands, except per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2011 | 2010 | |||||||
| Revenues: | ||||||||
| Collaboration revenue | $ | 366 | $ | 7,421 | ||||
| Grant revenue | 889 | 862 | ||||||
| Service and license revenue | 489 | 61 | ||||||
| Total revenues | 1,744 | 8,344 | ||||||
| Operating expenses: | ||||||||
| Research and development | 14,672 | 12,480 | ||||||
| General and administrative | 4,754 | 4,570 | ||||||
| Amortization of intangible assets | 245 | 245 | ||||||
| Total operating expenses | 19,671 | 17,295 | ||||||
| Loss from operations | (17,927 | ) | (8,951 | ) | ||||
| Interest income | 33 | 2 | ||||||
| Interest expense | (490 | ) | (399 | ) | ||||
| Other income (expense) | (82 | ) | 164 | |||||
| Net loss | $ | (18,466 | ) | $ | (9,184 | ) | ||
| Basic and diluted net loss per share | $ | (0.16 | ) | $ | (0.17 | ) | ||
| Shares used to compute basic net loss per share | 115,726 | 54,364 |
| DYNAVAX TECHNOLOGIES CORPORATION | |||||
| RECONCILIATION OF GAAP OPERATING EXPENSES TO PRO FORMA OPERATING EXPENSES | |||||
| (In thousands) | |||||
| (Unaudited) | |||||
| Three Months Ended March 31, | |||||
| 2011 | 2010 | ||||
| GAAP operating expenses | $ | 19,671 | $ | 17,295 | |
| LESS: Stock-based compensation expense | 1,480 | 541 | |||
| Amortization of intangible assets | 245 | 245 | |||
| Pro forma operating expenses (1) | $ | 17,946 | $ | 16,509 |
| DYNAVAX TECHNOLOGIES CORPORATION | ||||||
| SELECTED BALANCE SHEET DATA | ||||||
| (In thousands) | ||||||
| (Unaudited) | ||||||
| March 31, | December 31, | |||||
| 2011 | 2010 | |||||
| Assets | ||||||
| Cash and cash equivalents and marketable securities | $ | 53,203 | $ | 72,154 | ||
| Property and equipment, net | 6,516 | 6,404 | ||||
| Goodwill | 2,312 | 2,312 | ||||
| Other intangible assets, net | 54 | 299 | ||||
| Other assets | 3,422 | 3,080 | ||||
| Total assets | $ | 65,507 | $ | 84,249 | ||
| Liabilities and stockholders' equity | ||||||
| Accounts payable | $ | 1,880 | $ | 2,329 | ||
| Accrued liabilities | 8,158 | 10,943 | ||||
| Current portion of deferred revenue | 1,429 | 1,429 | ||||
| Noncurrent portion of deferred revenue | 5,298 | 5,655 | ||||
| Long-term note payable to Holdings | 11,407 | 10,939 | ||||
| Long-term contingent liability to Holdings | 840 | 843 | ||||
| Stockholders' equity | 36,495 | 52,111 | ||||
| Total liabilities and stockholders' equity | $ | 65,507 | $ | 84,249 |
Contact Information: Contacts:
Vice President, Finance