SOURCE: Dynavax Technologies

Dynavax Technologies

March 05, 2015 06:00 ET

Dynavax Reports Fourth Quarter and Year End 2014 Financial Results

BERKELEY, CA--(Marketwired - Mar 5, 2015) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2014.

The Company had $122.7 million in cash, cash equivalents and marketable securities as of December 31, 2014. Loss from operations of $91.3 million for the year ended December 31, 2014 increased by $24.8 million compared to the year ended December 31, 2013 primarily as a result of expenses relating to conduct of clinical trials. A Phase 3 clinical trial of hepatitis B vaccine HEPLISAV-B™ (known as HBV-23) was initiated in the second quarter of 2014 and an independent Data and Safety Monitoring Board (DSMB) reviewed available data in early November 2014 and late February 2015 and recommended continuation of the trial without change. A Phase 1/2 study of SD-101 in combination with local radiation for the treatment of indolent lymphoma was initiated in the fourth quarter.

The net loss allocable to common stockholders for the twelve months ended December 31, 2014 was $90.7 million, or $3.45 per basic and diluted share. The net loss allocable to common stockholders for the twelve months ended December 31, 2013 was $75.2 million, or $3.83 per basic and diluted share, which includes a one-time non-cash deemed dividend of $8.5 million related to the beneficial conversion feature of the Series B Convertible Preferred Stock.

About HEPLISAV-B

HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

About SD-101

SD-101 is a proprietary, second-generation, TLR 9 agonist CpG oligodeoxynucleotide (CPG ODN). In preclinical studies, TLR 9 agonists have shown activity as monotherapy or in combination with various interventions, including immunotherapeutic and tumor-specific antibodies. SD-101 has been evaluated in two Phase 1 studies to assess its preliminary safety and tolerability.

About Dynavax

Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.

   
DYNAVAX TECHNOLOGIES CORPORATION  
CONSOLIDATED STATEMENTS OF OPERATIONS  
(In thousands, except per share amounts)  
(Unaudited)  
   
    Three Months Ended
December 31,
    Years Ended
December 31,
 
    2014     2013     2014     2013  
Revenues:                                
  Collaboration revenue   $ 1,734     $ 1,580     $ 7,933     $ 4,929  
  Grant revenue     142       1,283       2,688       5,138  
  Service and license revenue     401       (16 )     411       1,184  
Total revenues     2,277       2,847       11,032       11,251  
                                 
Operating expenses:                                
  Research and development     19,638       12,131       84,580       50,870  
  General and administrative     5,052       3,700       17,377       25,943  
  Unoccupied facility expense     --       8       386       926  
Total operating expenses     24,690       15,839       102,343       77,739  
                                 
Loss from operations     (22,413 )     (12,992 )     (91,311 )     (66,488 )
                                 
Interest income     29       (47 )     191       116  
Interest expense     (35 )     83       (35 )     --  
Other income (expense), net     133       (100 )     433       (348 )
                                 
Net loss     (22,286 )     (13,056 )     (90,722 )     (66,720 )
                                 
Preferred stock deemed dividend     --       (8,469 )     --       (8,469 )
                                 
Net loss allocable to common stockholders   $ (22,286 )   $ (21,525 )   $ (90,722 )   $ (75,189 )
                                 
Basic and diluted net loss per share allocable to common stockholders   $ (0.85 )   $ (0.91 )   $ (3.45 )   $ (3.83 )
                                 
Shares used to compute basic and diluted net loss per share allocable to common stockholders     26,298       23,588       26,289       19,628  
                                 
 
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
 
    December 31,   December 31,
    2014   2013
Assets            
  Cash, cash equivalents and marketable securities   $ 122,652   $ 189,376
  Property and equipment, net     7,924     8,706
  Goodwill     2,277     2,579
  Other assets     5,437     3,961
Total assets   $ 138,290   $ 204,622
             
Liabilities and stockholders'equity            
  Deferred revenues   $ 12,765   $ 7,298
  Other liabilities     15,484     11,030
  Long-term debt     9,559     --
  Total liabilities     37,808     18,328
  Stockholders' equity     100,482     186,294
Total liabilities and stockholders' equity   $ 138,290   $ 204,622
             

Contact Information

  • Contact:
    Michael Ostrach
    Chief Financial Officer
    510-665-7257
    Email Contact