Novavax’s (NVAX) fourth quarter net loss per share came in at 15 cents, wider than the Zacks Consensus Estimate of a loss of 5 cents. The year-ago loss was 16 cents. For 2009, the company reported a loss per share of 45 cents compared to a loss of 53 cents in 2008.
The decline in net loss per share was primarily due to an increase in the number of shares. Total net loss increased to $13.95 million during the reported quarter compared to $11.08 million in the year ago period.
Novavax, a vaccine developer, does not have any marketed products at present. A 34.8% increase in operating expenses led to the increased loss for the company. With the progress made by the company in the development process of its vaccines, research and development (R&D) expenses increased 87% year-over-year to $10.96 million.
Year 2009 has been quite significant for Novavax. In Sep 2009, the company made a major breakthrough in a phase II clinical trial of its trivalent seasonal influenza virus-like particle (VLP) vaccine candidate.
While the trial carried out on 221 people (aged 18 to 49 years) showed strong immune system responses against three flu strains (H3N2, H1N1, and B), no major adverse events were reported. The company expects to begin a phase III study this year.
Novavax has launched a large clinical study for its H1N1 vaccine in Mexico in collaboration with Avimex Laboratories and GE Healthcare. Final results from this study are expected in 2010. If the results are encouraging, the company expects to get the vaccine approved in Mexico.
Novavax has also identified a vaccine candidate for the prevention of respiratory syncytial virus (RSV). The company plans to complete preparations for its Investigational New Drug (IND) filing for the vaccine in 2010.
Spurred by the advancement of several of its clinical development programs, Novavax raised $45 million from equity offerings. The company exited 2009 with $43 million in cash, cash equivalents and short-term investments, up from $33.9 at the end of 2008. We are pleased to note that Novavax has retired $22 million of convertible debt.
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