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Dynavax Technologies Corporation (DVAX) Reports Third Quarter 2012 Financial Results


11/1/2012 12:45:12 PM

BERKELEY, CA--(Marketwire - November 01, 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     Nine Months Ended  
                                     September 30,         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
                                                 ============= =============
                                                                            
                                                                            

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

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


Read at BioSpace.com


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