PRINCETON, N.J., Dec. 31 /PRNewswire-FirstCall/ -- Pharmasset, Inc. , a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported audited financial results for the fiscal year ended September 30, 2007. Pharmasset reported a net loss attributable to common stockholders of $6.8 million, or $0.46 per share, as compared to a net loss attributable to common stockholders of $12.4 million, or $1.19 per share for the same period in 2006.
Revenues were $22.0 million during the fiscal year 2007, primarily consisting of development milestones and the amortization of payments received from Roche from the hepatitis C virus (HCV) collaboration agreement that were previously recorded as deferred revenue. Revenues for the same period in 2006 were $5.4 million. This $16.6 million increase from the year ago period was primarily due to the receipt of milestone payments from Roche totaling $20.0 million during fiscal year 2007. Investment income was $2.5 million during fiscal year 2007 compared to $1.7 million during fiscal year 2006. This $0.8 million increase was due to higher average invested cash balances during 2007.
Total costs and expenses for the fiscal year ended September 30, 2007 were $29.5 million as compared to $18.4 million for the same period in 2006. The increased operating expenses for fiscal year 2007 were primarily the result of an increase in Phase 3 registration clinical trial expenses for clevudine for the treatment of chronic hepatitis B virus (HBV) infection, as well as drug discovery, non-cash stock compensation and depreciation expenses.
At September 30, 2007, Pharmasset held $68.7 million in cash and cash equivalents and approximately $1.3 million of short-term investments. In September 2007, Pharmasset entered into a $30 million working capital loan agreement, of which $10 million was funded in October 2007.
“Pharmasset achieved significant clinical development and financial progress in 2007,” stated Schaefer Price, Pharmasset’s President & CEO. “We remain focused on building our hepatitis and HIV franchises with novel drug candidates that could significantly improve therapeutic standards of care. We hope to maintain the momentum in 2008 by completing HBV patient enrollment of the clevudine Phase 3 clinical trials for registration in the Americas and Europe. In addition, since the first two cohorts were fully enrolled earlier this month, we plan to report preliminary safety and efficacy data following 4 weeks of combination therapy with R7128 and Pegasys(R) plus Copegus(R) in the first calendar quarter of 2008.”
About Pharmasset
Pharmasset is a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset’s primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is enrolling Phase 3 clinical trials for registration in North, Central and South America and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an orally administered treatment for chronic HCV infection, is in a 4-week Phase 1 clinical trial in combination with Pegasys(R) and Copegus(R) through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.
alan.roemer@pharmasset.com
Forward-Looking Statements
Pharmasset “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are “forward-looking statements” that involve risks and uncertainties, including without limitation the risk that adverse events could cause the cessation of the Phase 3 registration studies and/or our development of clevudine, the risk that adverse events could cause the cessation of the Phase 1 combination study and/or our development of R7128, including the risk that we will fail to release preliminary or final safety and efficacy data from a Phase 1, Part 3 multiple ascending dose study and the risk that we will fail to initiate a Phase 2b combination study of R7128 with Pegasys plus Copegus in the second calendar half of 2008, the risk that our collaboration with Roche will not continue or will not be successful and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Annual Report on Form 10-K for the fiscal year ended September 30, 2007 filed with the Securities and Exchange Commission entitled “Risk Factors” and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.
CONTACT: Alan Roemer, Vice President, Investor Relations & Corporate
Communications, Pharmasset, Inc., +1-609-613-4125,
alan.roemer@pharmasset.com
Web site: http://www.pharmasset.com/
