BERKELEY, CA--(Marketwire - Nov 1, 2012) - Dynavax Technologies Corporation (
Total revenues for the quarter ended September 30, 2012 were $2.9 million compared to $1.2 million for the quarter ended September 30, 2011, due primarily to higher collaboration and grant revenue recognized as a result of research and development reimbursable under Dynavax's partnerships with AstraZeneca and the National Institute of Allergy and Infectious Diseases.
Research and development expenses for the quarter ended September 30, 2012 were $12.9 million compared to $11.8 million for the quarter ended September 30, 2011. Increased research and development expenses in the third quarter of 2012 were primarily attributed to manufacturing and regulatory activities for HEPLISAV™.
General and administrative expenses for the quarter ended September 30, 2012 were $7.1 million compared to $4.2 million for the quarter ended September 30, 2011. General and administrative expenses increased primarily due to growth in the organization and activities to prepare for and support the commercial launch of HEPLISAV in the United States.
Recent Developments
Dynavax reported the following recent developments:
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine for which U.S. and European licensure applications have been accepted for review by the FDA and EMA. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.
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DYNAVAX TECHNOLOGIES CORPORATION | |||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(In thousands, except per share amounts) | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
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2012 | 2011 | 2012 | 2011 | ||||||||||||||
Revenues: | |||||||||||||||||
Collaboration revenue | $ | 1,050 | $ | 369 | $ | 3,602 | $ | 7,098 | |||||||||
Grant revenue | 1,219 | 658 | 3,188 | 2,437 | |||||||||||||
Service and license revenue | 605 | 147 | 1,118 | 652 | |||||||||||||
Total revenues | 2,874 | 1,174 | 7,908 | 10,187 | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | 12,850 | 11,777 | 36,631 | 39,706 | |||||||||||||
General and administrative | 7,121 | 4,217 | 18,871 | 13,025 | |||||||||||||
Amortization of intangible assets | - | - | - | 299 | |||||||||||||
Total operating expenses | 19,971 | 15,994 | 55,502 | 53,030 | |||||||||||||
Loss from operations | (17,097 | ) | (14,820 | ) | (47,594 | ) | (42,843 | ) | |||||||||
Interest income | 91 | 18 | 208 | 74 | |||||||||||||
Interest expense | (589 | ) | (485 | ) | (1,765 | ) | (1,462 | ) | |||||||||
Other income (expense) | (196 | ) | 58 | (255 | ) | (99 | ) | ||||||||||
Net loss | $ | (17,791 | ) | $ | (15,229 | ) | $ | (49,406 | ) | $ | (44,330 | ) | |||||
Basic and diluted net loss per share | $ | (0.10 | ) | $ | (0.12 | ) | $ | (0.30 | ) | $ | (0.37 | ) | |||||
Shares used to compute basic and diluted net loss per share | 177,870 | 124,069 | 167,039 | 119,244 | |||||||||||||
DYNAVAX TECHNOLOGIES CORPORATION | |||||||
SELECTED BALANCE SHEET DATA | |||||||
(In thousands) | |||||||
(Unaudited) | |||||||
September 30, | December 31, | ||||||
2012 | 2011 | ||||||
Assets | |||||||
Cash and cash equivalents and marketable securities | $ | 148,279 | $ | 113,961 | |||
Property and equipment, net | 6,948 | 6,163 | |||||
Goodwill | 2,408 | 2,312 | |||||
Other assets | 7,187 | 11,666 | |||||
Total assets | $ | 164,822 | $ | 134,102 | |||
Liabilities and stockholders' equity | |||||||
Deferred revenues | $ | 8,947 | $ | 10,596 | |||
Short-term note payable | 14,452 | 12,810 | |||||
Other liabilities | 11,365 | 10,816 | |||||
Total liabilities | 34,764 | 34,222 | |||||
Stockholders' equity | 130,058 | 99,880 | |||||
Total liabilities and stockholders' equity | $ | 164,822 | $ | 134,102 | |||
Contact Information:
Contacts:
Cris Larson
Chief Financial Officer
510-665-7222
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257