Novavax Reports Fourth Quarter and Year-End 2012 Financial Results

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| Source: Novavax, Inc.

ROCKVILLE, Md., March 1, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced financial results for the fourth quarter and year-ended December 31, 2012.

For the fourth quarter of 2012, Novavax reported a net loss of $8.0 million, or $0.06 per share, compared to a net loss of $3.7 million, or $0.03 per share, in the fourth quarter of 2011. For 2012, the company reported a net loss of $28.5 million, or $0.22 per share, compared to a net loss of $19.4 million, or $0.17 per share, for 2011. The increase in the net loss in 2012 compared to 2011 was primarily a result of higher research and development spending, including increased costs related to respiratory syncytial virus (RSV) clinical trials, higher employee-related costs and expenses associated with the company's new manufacturing facility.

At December 31, 2012, Novavax had cash, cash equivalents and investments totaling $50.3 million compared to $18.3 million at December 31, 2011. Net cash used in operating activities for 2012 was $18.2 million compared to $23.6 million for 2011, a 23% reduction from the prior year. Working capital at December 31, 2012 was $38.7 million compared to $18.5 million at December 31, 2011, which represents a 109% increase.

Stanley C. Erck, President and Chief Executive Officer of Novavax, stated, "In 2012 we made significant progress across our complete pipeline of vaccine candidates, with positive clinical data announced for our RSV vaccine candidate, as well as our seasonal and pandemic (H5N1) influenza vaccines. Of particular note are results we announced last October from two Phase I pandemic (H5N1) influenza vaccine trials, which showed highly robust immunogenicity at multiple dose levels both with and without two separate adjuvants, and evidence of cross protection against a mismatched strain. This positive influenza data has undergone inter-governmental-agency panel review, and the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) is continuing support of our vaccine advanced development contract.

Mr. Erck continued, "In addition, we signed a $2 million clinical development agreement with PATH to support the Phase II clinical trial of our RSV vaccine candidate in women of childbearing age. We expect to report top-line data from this study in April and, as a result, we believe our program is currently the most advanced RSV vaccine development effort in the pharmaceutical industry."

Key Highlights of 2012:

In 2012, we initiated five clinical trials, enrolling approximately 1,700 subjects in three separate clinical development programs, while enhancing our existing development alliances and adding a new development alliance.

Pandemic (H5N1) Influenza Vaccine Program:

  • In October 2012, we reported on two Phase I clinical trials that demonstrated the safety and immunogenicity of varying dose-levels of this vaccine, with and without two separate adjuvants, as well as statistically significant effects on immune response. The data suggested that our vaccine may be protective even when the vaccine strain does not perfectly match a pandemic virus strain, which is an important consideration in the emergent response to a pandemic. We believe that the data generated for our pandemic influenza vaccine are as good as or better than any published pandemic influenza clinical trial results.

Seasonal Influenza Vaccine Program:

  • In July 2012, we reported that a Phase II dose-ranging clinical trial of our quadrivalent seasonal influenza vaccine met the U.S. Food and Drug Administration's seroprotection requirements for all four viral strains that were included in the vaccine, as well as the agency's required seroconversion levels for three out of the four strains. The vaccine was well-tolerated and produced no vaccine-related serious adverse events.

RSV Vaccine Program:

  • In October 2012, we initiated two clinical trials for our RSV vaccine candidate: a Phase II clinical trial in women of child bearing age and a Phase I clinical trial in the elderly.
     
  • In September 2012, we presented findings from our RSV vaccine development program at the 8th Annual International Respiratory Virus Symposium (RSV 2012) meeting. Poster presentations described the functional activity of our vaccine candidate and reported both pre-clinical and Phase I clinical trial results demonstrating induction of functional, neutralizing antibodies to multiple sites on the F protein that have a high binding affinity.

Corporate and Alliance Developments:

  • During 2012, we recognized approximately $20 million in revenue from BARDA to fund the advanced development research contract for our influenza vaccine program.
     
  • In July 2012, we signed a $2 million clinical development agreement with PATH to support a Phase II clinical trial of our RSV vaccine in women of childbearing age.
     
  • In July 2012, CPL Biologicals (CPLB), our joint venture with Cadila Pharmaceuticals in India, announced a new collaboration with the International Centre for Genetic Engineering and Biotechnology to develop a new malaria vaccine candidate. The program is funded by the government of India and managed by the Malaria Vaccine Development Program, a New Delhi-based not-for-profit organization established to support the development of malaria vaccines.
     
  • CPLB also initiated two Phase I clinical trials in India: one in its trivalent seasonal influenza vaccine candidate and the other in its pandemic (H1N1) influenza vaccine candidate. Both vaccine candidates were manufactured in India using Novavax' gene sequences and VLP platform technology.
     
  • In 2012, we raised net proceeds of approximately $54 million, completing two equity offerings which generated net proceeds of approximately $39 million and raising approximately $15 million through our at-market sales facility.

Anticipated Events in 2013:

  • Following the January 2013 inter-governmental-agency panel review of our vaccine-development contract with BARDA, we will continue our research activities and ultimately advance our seasonal influenza and pandemic (H5N1) influenza vaccine candidates into later-stage clinical trials under the BARDA program.
     
  • Top-line data from our two on-going RSV clinical trials are expected to be reported during the second quarter of 2013, and the design and timing of subsequent clinical trials will be determined after these data are analyzed.
     
  • CPLB is expected to initiate a clinical trial for a recombinant nanoparticle rabies vaccine candidate in India.
     
  • We expect to continue to advance the company's research collaborations with CPLB in India, LG Life Sciences in South Korea and PATH.
     
  • We are completing our expansion into new manufacturing and office facilities in Gaithersburg, Maryland and are scheduling GMP manufacturing of product for later-stage clinical trials. This facility is designed to allow us to produce vaccines for all stages of clinical development through to commercialization.

Conference Call

Novavax' management will host the company's quarterly conference call today at 10:00 a.m. Eastern time. The conference call will be accessible at that time on Novavax' website at www.novavax.com under "Investor Info/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 60 days after the call and a replay of the conference call will be available beginning today at 1:00 pm through April 29, 2013. To access the replay of the conference call, dial 1 (855) 859-2056 (Domestic) or 1 (404) 537-3406 (International) and enter passcode 13572606.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces 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, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have 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 VLP 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, 2011, and filed with the Securities and Exchange Commission (SEC). 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 Twelve Months Ended
  December 31, December 31,
  2012 2011 2012 2011
  (unaudited)    
Revenue  $ 4,567  $ 5,845  $ 22,076  $ 14,688
         
Costs and expenses:      
Cost of revenue 1,953 3,206 14,692 7,003
Research and development 9,411 4,446 26,061 17,885
General and administrative 2,697 2,453 10,988 11,379
Total costs and expenses 14,061 10,105 51,741 36,267
Loss from operations (9,494) (4,260) (29,665) (21,579)
Interest income (expense), net 33 28 133 127
Other income 45 26 45 26
Realized gains on short-term investments 879 879
Change in fair value of warrant liability 502 501 101 2,474
Loss from operations before income tax (8,035) (3,705) (28,507) (18,952)
Income tax expense 412
Net loss  $ (8,035)  $ (3,705)  $ (28,507)  $ (19,364)
         
Basic and diluted net loss per share  $ (0.06)  $ (0.03)  $ (0.22)  $ (0.17)
Basic and diluted weighted average    
number of common shares outstanding 145,069 115,263 131,726 113,610

 

 
SELECTED BALANCE SHEET DATA
(in thousands)
 
  December 31,  
2012
December 31,
 2011
     
Cash and cash equivalents $ 17,399 $ 14,104
Investments  32,945  4,205
Total current assets  50,408  26,109
Working capital  38,733  18,530
Total assets  102,345  66,576
Total notes payable and capital lease obligation  1,205  320
Total stockholders' equity  80,240  53,849
Frederick W. Driscoll
VP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000