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.
Dynavax reported the following recent developments:
- In June 2012, we reported that the FDA has established February 24, 2013, as the Prescription Drug User Fee Act (PDUFA) action date for our HEPLISAV Biologics License Application, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age. In August 2012, the FDA informed the Company that its Vaccines and Related Biological Advisory Committee is scheduled to discuss HEPLISAV at its meeting on November 15, 2012.
- In July 2012, the American Medical Association Current Procedural Terminology (CPT) Panel established a CPT code for an adult two dose hepatitis B vaccination schedule. CPT codes are designed to communicate uniform information about medical services and procedures among physicians and payers for administrative and financial purposes. If approved, HEPLISAV will be reported using the new two dose code, differentiating it from a three dose hepatitis B vaccine schedule.
- In July 2012, we filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for HEPLISAV for use in adults 18 through 70 years of age and in patients with chronic kidney disease. The Company was subsequently notified in August 2012 by the EMA that its MAA was accepted for review. The EMA is a European Union agency responsible for the evaluation of medicinal products that allows companies to submit a single application for marketing authorization in all European Union and European Economic Area European Free Trade Association states.
- In October 2012, we and AstraZeneca agreed to advance AZD1419, a proprietary second generation TLR-9 agonist for asthma, towards a Phase 1 clinical trial, which entitles us to a development milestone payment of $6 million.
HEPLISAV is an investigational adult hepatitis B vaccine for which U.S. and European licensure applications have been accepted for review by the FDA and EMA. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known to enhance the immune response.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.
- tables to follow -
|DYNAVAX TECHNOLOGIES CORPORATION|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three Months Ended |
|Nine Months Ended |
|Service and license revenue||605||147||1,118||652|
|Research and development||12,850||11,777||36,631||39,706|
|General and administrative||7,121||4,217||18,871||13,025|
|Amortization of intangible assets||-||-||-||299|
|Total operating expenses||19,971||15,994||55,502||53,030|
|Loss from operations||(17,097||)||(14,820||)||(47,594||)||(42,843||)|
|Other income (expense)||(196||)||58||(255||)||(99||)|
|Basic and diluted net loss per share||$||(0.10||)||$||(0.12||)||$||(0.30||)||$||(0.37||)|
|Shares used to compute basic and diluted net loss per share||177,870||124,069||167,039||119,244|
|DYNAVAX TECHNOLOGIES CORPORATION|
|SELECTED BALANCE SHEET DATA|
|September 30,||December 31,|
|Cash and cash equivalents and marketable securities||$||148,279||$||113,961|
|Property and equipment, net||6,948||6,163|
|Liabilities and stockholders' equity|
|Short-term note payable||14,452||12,810|
|Total liabilities and stockholders' equity||$||164,822||$||134,102|