SOURCE: Dynavax Technologies

Dynavax Technologies

August 07, 2015 16:01 ET

Dynavax Reports Second Quarter 2015 Financial Results

BERKELEY, CA--(Marketwired - Aug 7, 2015) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the second quarter ended June 30, 2015.

The Company had $93.4 million in cash, cash equivalents and marketable securities as of June 30, 2015, compared to $97.6 million at March 31, 2015. The cash, cash equivalents and marketable securities balance as of June 30, 2015 includes net proceeds of approximately $20.2 million as a result of stock sales under an at the market sales agreement (ATM). In July 2015, the Company received additional cash of approximately $29 million resulting from stock sales under the ATM and also completed an underwritten public offering of common stock resulting in net proceeds of approximately $135 million.

Operating expenses of $24.8 million for the quarter ended June 30, 2015 decreased by $2.3 million compared to the quarter ended March 31, 2015 as clinical costs associated with HBV-23, the ongoing Phase 3 clinical study of HEPLISAV-B™, Dynavax's investigational adult hepatitis B vaccine, began to decline as it progressed towards its expected completion in October 2015. 

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. The net loss allocable to common stockholders for the quarter ended March 31, 2015 was $26.2 million, or $0.97 per basic and diluted share.

"With the completion of our recent financing we are well positioned to support the ongoing development of HEPLISAV-B and SD-101, our investigational cancer immunotherapeutic product, and to continue preparations for the anticipated commercial launch of HEPLISAV-B in the United States, subject to approval by the Food and Drug Administration," said Eddie Gray, Chief Executive Officer of Dynavax.

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 our development and commercialization plans for our product candidates, including HEPLISAV-B and SD-101 and financial projections. 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 release. 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
June 30,
    Six Months Ended
June 30,
 
  2015     2014     2015     2014  
Revenues:                              
  Collaboration revenue $ 930     $ 2,031     $ 1,401     $ 4,404  
  Grant revenue   101       1,007       249       2,132  
  Service and license revenue   519       10       527       10  
Total revenues   1,550       3,048       2,177       6,546  
                               
Operating expenses:                              
  Research and development   19,686       23,639       41,906       36,870  
  General and administrative   5,098       4,085       9,957       8,242  
  Unoccupied facility expense   -       178       -       255  
Total operating expenses   24,784       27,902       51,863       45,367  
                               
Loss from operations   (23,234 )     (24,854 )     (49,686 )     (38,821 )
                               
Interest income   18       55       45       120  
Interest expense   (263 )     -       (510 )     -  
Other (loss) income   (112 )     22       343       84  
                               
Net loss $ (23,591 )   $ (24,777 )   $ (49,808 )   $ (38,617 )
                               
Basic and diluted net loss per share $ (0.80 )   $ (0.94 )   $ (1.70 )   $ (1.47 )
                               
Shares used to compute basic and diluted net loss per share   29,335       26,286       29,230       26,286  
                               
 
 
DYNAVAX TECHNOLOGIES CORPORATION
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
 
  June 30,   December 31,
  2015   2014
Assets          
  Cash, cash equivalents and marketable securities $ 93,381   $ 122,652
  Property and equipment, net   8,887     7,924
  Goodwill   2,078     2,277
  Other assets   5,148     5,437
Total assets $ 109,494   $ 138,290
           
Liabilities and stockholders'equity          
  Deferred revenues $ 11,364   $ 12,765
  Other liabilities   15,641     15,484
  Long-term debt   7,961     9,559
  Total liabilities   34,966     37,808
  Stockholders' equity   74,528     100,482
Total liabilities and stockholders' equity $ 109,494   $ 138,290
           

Contact Information

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