NOVAVAX Reports Second Quarter 2012 Financial Results

GlobeNewswire

Friday, August 3rd 2012

ROCKVILLE, Md., Aug. 3, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced its financial results for the second quarter and six months ended June 30, 2012.

Second Quarter 2012 and Subsequent Highlights:

Reported positive safety and immunogenicity top-line results from the company's Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate. The vaccine candidate was well tolerated and demonstrated immunogenicity against all four viral strains studied. Novavax plans to initiate further Phase II testing next year under the company's vaccine development contract with Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority (HHS BARDA).
Launched two Phase I clinical trials of Novavax's A/H5N1avian influenza vaccine candidate also under the company's contract with HHS BARDA. The trials are fully enrolled, and randomized healthy subjects in six treatment groups are being evaluated to determine the vaccine candidate's safety and immunogenicity. Results are expected in the fourth quarter of this year.
Announced collaboration with PATH along with an initial award of approximately $2 million in funding to support clinical testing of the company's respiratory syncytial virus (RSV) vaccine candidate. These funds will be used to support a Phase II dose-ranging study in women of child-bearing age which is scheduled to begin during the second half of this year.
Launched a new collaboration with CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology to develop a new VLP-based malaria vaccine in India. The project is funded by the government of India and will be managed by India's non-profit Malaria Vaccine Development Program.
Reported progress under the company's RSV vaccine program at the first Modern Vaccines, Adjuvants and Delivery Systems conference in Copenhagen. Dr. Gregory Glenn discussed new insights regarding the immune responses to the company's RSV F vaccine candidate versus natural infections that indicate that only the RSV F nanoparticle induces palivizumab-like antibodies.
Strengthened the Company's balance sheet by completing a $12.1 million equity offering.

"In the second quarter we made solid progress in our vaccine programs and laid a strong foundation for what should be a very eventful year to come. We continued to advance our vaccine programs by launching new partnerships, generating positive new data for vaccine candidates, and raising incremental capital," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Our seasonal and pandemic influenza vaccine candidates will move into later-stage testing next year providing insight and validation into their clinical and commercial potential. We are excited about our new collaboration with PATH which will allow us to launch a Phase II clinical trial of our RSV vaccine candidate in women of childbearing age in the fourth quarter. In the meantime, we are working diligently to complete our ongoing Phase I clinical trials for our A/H5N1avian influenza vaccine candidate and anticipate releasing top-line data in the fourth quarter."

Second Quarter and First Half 2012 Financial Results

The company reported a net loss of $5.9 million, or $0.05 per share, for the second quarter of 2012, compared to a net loss of $5.0 million, or $0.04 per share, for the second quarter of 2011. For the six months ended June 30, 2012, the net loss was $13.3 million, or $0.11 per share, compared to a net loss of $12.4 million, or $0.11 per share, for the same period in 2011.

Revenue in the second quarter of 2012 increased to $7.1 million as compared to $3.0 million for the same period in 2011, which represents a 137% increase, as a result of the Company's contract with the HHS BARDA. In conjunction with this increased HHS BARDA revenue, cost of revenue increased to $5.1 million in the second quarter of 2012 as compared to $1.2 million for the same period in 2011. Research and development expenses increased to $5.2 million in the second quarter of 2012 as compared to $4.4 million for the same period in 2011, primarily due to higher employee-related costs and expenses associated with our new manufacturing facility. General and administrative expenses decreased to $2.7 million in the second quarter of 2012 as compared to $3.3 million for the same period in 2011 primarily resulting from lower employee-related costs, including severance expenses, partially offset by non-cash expenses associated with our new office facility.