NOVAVAX Reports Third Quarter 2011 Financial Results


ROCKVILLE, Md., Nov. 4, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced financial results for the third quarter ended September 30, 2011.

Novavax reported a net loss of $3.2 million, or $0.03 per share, for the third quarter of 2011 compared to a net loss of $10.2 million, or $0.10 per share, for the third quarter of 2010. For the nine months ended September 30, 2011, the net loss was $15.7 million, or $0.14 per share, compared to a net loss of $29.4 million, or $0.29 per share, for the same period in 2010.  The primary reason for the decreased loss for the third quarter of 2011 as compared to the same period in 2010 was due to revenue recognized under the contract with the Office of Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS), awarded in February 2011, as well as lower research and development spending to support the company's clinical trials related to its vaccine candidates.

Research and development (R&D) expenses for the third quarter of 2011 were $6.2 million as compared to $7.9 million in the same period in 2010. The decrease in R&D expenses was due primarily to lower outside-testing costs, partially offset by higher employee-related costs. General and administrative expenses were $2.7 million for the third quarter of 2011 as compared to $2.8 million in the same period in 2010.

As of September 30, 2011, the company had $19.6 million in cash, cash equivalents and short-term investments compared to $31.7 million as of December 31, 2010.

Recent Business Highlights:

  • Reported positive top-line results from Phase 1 study of vaccine to prevent respiratory syncytial virus (RSV), the most important viral cause of lower respiratory tract infection in infants and children worldwide. Vaccine candidate was well-tolerated with no vaccine-related serious adverse events. A significant dose response pattern to the RSV-F antibody was observed and high rates of sero-conversion were seen in all doses, with 100% at the highest dose adjuvant group;
  • Received $1.3 million contract award from the U.S. Department of Homeland Security to develop a virus-like-particle (VLP) vaccine to prevent foot-and-mouth disease, a highly contagious viral disease of livestock and a potential threat to U.S. agriculture; and
  • Published positive safety and immunogenicity results from H1N1 influenza vaccine trial in Mexico, the first peer-reviewed publication of clinical data generated using Novavax's influenza VLPs.

Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: "With the recent impressive results from our Phase 1 RSV vaccine study, we now have three promising vaccine candidates in clinical testing to address urgent public health needs. We look forward to advancing our RSV vaccine candidate into later-stage testing and to initiating new clinical testing of our vaccine candidates to prevent seasonal and pandemic influenza under the HHS BARDA contract. In addition, our recent contract award to develop a vaccine to prevent foot-and-mouth disease in livestock opens up an important new avenue of vaccine research and development for our company."

Conference Call

Novavax's management will host its quarterly conference call today at 10:00 a.m. Eastern time today.  The live conference call will be accessible on Novavax's website at www.novavax.com under "Investor/Events" or by telephone at 1 (877) 212-6076 (domestic) or 1 (707) 287-9331 (international).  A replay of the webcast will be available on the Novavax website for 90 days after the call and a replay of the conference call will be available beginning today at 1:00 pm.  To access the replay of the conference call, dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and enter pass code 23074432.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide.  Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections.  Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea.  Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field.  Additional information about Novavax is available on the company's website: www.novavax.com.

Forward Looking Statements

Statements herein relating to the future of Novavax and its ongoing development of its vaccine products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2010, and filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

NOVAVAX, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
         
         
  Three Months Ended Nine Months Ended
  September 30, September 30,
  2011 2010 2011 2010
  (unaudited) (unaudited)
Revenue  $ 5,008  $ 175  $ 8,843  $ 292
         
Operating expenses:        
Research and development 6,239 7,870 17,237 23,226
General and administrative 2,737 2,844 8,926 8,528
Total operating expenses 8,976 10,714 26,163 31,754
Loss from operations (3,968) (10,539) (17,320) (31,462)
Interest income (expense), net 20 48 100 132
Change in fair value of warrant liability 736 133 1,973 1,771
Loss from operations before income tax (3,212) (10,358) (15,247) (29,559)
Income tax (benefit) expense (136) 412 (136)
Net loss  $ (3,212)  $ (10,222)  $ (15,659)  $ (29,423)
         
Basic and diluted net loss per share  $ (0.03)  $ (0.10)  $ (0.14)  $ (0.29)
Basic and diluted weighted average number of common shares outstanding 115,107 107,092 113,053 102,683
         
SELECTED BALANCE SHEET DATA
(in thousands)
 
   
  September 30,  
2011
December 31, 2010
  (unaudited)  
Cash and cash equivalents $ 14,318 $ 8,061
Short-term investments  5,286  23,615
Total current assets  26,253  33,337
Working capital  19,512  23,071
Total assets  67,085  74,844
Total notes payable  340  400
Total stockholders' equity  54,597  59,050


            

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