Dynavax Reports Third Quarter 2012 Financial Results

Marketwired

BERKELEY, CA--(Marketwire - Nov 1, 2012) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2012. The Company had $148.3 million in cash, cash equivalents and marketable securities as of September 30, 2012.

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:

  • 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.

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.

- tables to follow -

   
DYNAVAX TECHNOLOGIES CORPORATION  
CONSOLIDATED STATEMENTS OF OPERATIONS  
(In thousands, except per share amounts)  
(Unaudited)  
   
    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    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:

Cris Larson
Chief Financial Officer
510-665-7222
Email Contact

Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
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