SOURCE: Dynavax Technologies

Dynavax Technologies

November 05, 2015 07:00 ET

Dynavax Reports Third Quarter 2015 Financial Results

BERKELEY, CA--(Marketwired - Nov 5, 2015) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2015.

The Company had $220.7 million in cash, cash equivalents and marketable securities as of September 30, 2015, compared to $93.4 million at June 30, 2015. The balance at September 30, 2015 includes approximately $164 million of net proceeds from sales of common stock in the third quarter and reflects payment of all principal and accrued interest, prepayment charges and other fees totaling approximately $11 million under a loan agreement.

Operating expenses of $29.6 million for the quarter ended September 30, 2015 increased by $4.8 million compared to the quarter ended June 30, 2015 primarily due to production, clinical trial and commercial preparation costs.

We recently initiated a clinical trial to evaluate the combination of our cancer immunotherapeutic product candidate SD-101 and Merck's KEYTRUDA® (pembrolizumab) in patients with metastatic melanoma. All study visits for HBV-23, the Phase 3 clinical study of HEPLISAV-B™, were completed in October 2015. Top line results of this study are expected to be released in early 2016. 

The net loss allocable to common stockholders for the quarter ended September 30, 2015 was $30.1 million, or $0.82 per basic and diluted share. The net loss allocable to common stockholders for the quarter ended June 30, 2015 was $23.6 million, or $0.80 per basic and diluted share.

About Dynavax

Dynavax, a clinical-stage biopharmaceutical company, uses TLR biology to discover and develop novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax's lead product candidates are HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine, and SD-101, an investigational cancer immunotherapeutic currently in several Phase 1/2 studies. For more information visit www.dynavax.com.

Forward Looking Statements

This release contains forward-looking statements, including statements regarding expected timing of results from HBV-23. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether HBV-23 can be completed as expected, whether the endpoints of the study will be achieved and the final results otherwise be satisfactory, whether successful development and approval of HEPLISAV-B and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays; whether clinical studies for our products can be enrolled, supplied and completed in a timely manner and will be sufficient for further development or for marketing approval; the potential size and value of approved indications addressable with HEPLISAV-B and the commercial potential for HEPLISAV-B; initiation and completion of pre-clinical studies and clinical trials of our other product candidates; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; achieving the objectives of and maintaining our collaborative and licensing agreements; our ability to execute on our commercial strategies; whether our financial resources will be adequate without the need to obtain additional financing and other risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this presentation. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available.

- 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,
 
  2015     2014     2015     2014  
Revenues:                              
  Collaboration revenue $ 829     $ 1,795     $ 2,230     $ 6,199  
  Grant revenue   359       414       608       2,546  
  Service and license revenue   -       -       527       10  
Total revenues   1,188       2,209       3,365       8,755  
                               
Operating expenses:                              
  Research and development   24,105       28,072       66,011       64,942  
  General and administrative   5,524       4,083       15,481       12,325  
  Unoccupied facility expense   -       131       -_       386  
Total operating expenses   29,629       32,286       81,492       77,653  
                               
Loss from operations   (28,441 )     (30,077 )     (78,127 )     (68,898 )
                               
Interest income   33       42       78       162  
Interest expense   (62 )     -       (572 )     -  
Other income, net   17       216       360       300  
Loss on extinguishment of debt   (1,671 )     -       (1,671 )     -  
                               
Net loss $ (30,124 )   $ (29,819 )   $ (79,932 )   $ (68,436 )
                               
Basic and diluted net loss per share $ (0.82 )   $ (1.13 )   $ (2.43 )   $ (2.60 )
                               
Shares used to compute basic and diluted net loss per share   36,532       26,291       32,880       26,288  
                               
                               
                               
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
 
  September 30,   December 31,
  2015   2014
  (unaudited)    
Assets          
  Cash, cash equivalents and marketable securities $ 220,697   $ 122,652
  Property and equipment, net   11,606     7,924
  Goodwill   2,106     2,277
  Other assets   4,498     5,437
Total assets $ 238,907   $ 138,290
           
Liabilities and stockholders'equity          
  Deferred revenues $ 10,546   $ 12,765
  Other liabilities   17,173     15,484
  Long-term debt   -     9,559
  Total liabilities   27,719     37,808
  Stockholders' equity   211,188     100,482
Total liabilities and stockholders' equity $ 238,907   $ 138,290
           

Contact Information

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