PRINCETON, N.J., Feb. 14 /PRNewswire-FirstCall/ -- Pharmasset, Inc. , a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported unaudited financial results for the first fiscal quarter of 2008 ended December 31, 2007. Pharmasset reported a net loss attributable to common stockholders of $12.2 million, or ($0.57) per share for the first fiscal quarter of 2008, as compared to net income attributable to common stockholders of $3.6 million, or $0.33 per diluted share for the same period in fiscal 2007.
Revenues were $0.5 million during the first fiscal quarter of 2008, which consisted of 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 fiscal 2007 were $8.1 million, which included a $7.5 million milestone payment received from Roche. Investment income was $0.9 million during the first fiscal quarter of 2008 compared to $0.4 million during the same period in 2007. The $0.5 million increase in the first fiscal quarter of 2008 was due to higher average invested cash balances.
Total costs and expenses for the first fiscal quarter of 2008 were $13.2 million as compared to $4.6 million for the same period in fiscal 2007. The $8.6 million increase in operating expenses for the first fiscal quarter of 2008 was primarily due to a $7.0 million increase in Phase 3 registration clinical trial expenses for clevudine for the treatment of chronic hepatitis B virus (HBV) infection, as well as approximately $1.6 million in drug discovery, compensation, insurance, audit and non-cash stock compensation expenses. Interest expense was $0.4 million during the first fiscal quarter of 2008 compared to $1,800 during the same period in fiscal 2007. The increase was primarily due to interest paid on the $10.0 million of long-term debt we incurred during October 2007.
At December 31, 2007, Pharmasset held $61.5 million in cash and cash equivalents and approximately $1.3 million of short-term investments.
“We collected preliminary results of the R7128 combination study for the treatment of HCV in the first fiscal quarter of 2008, and we look forward to orally presenting the final results of these two cohorts at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) in April 2008,” stated Schaefer Price, Pharmasset’s Chief Executive Officer. “The rapid advancement of the R7128 program is a tribute to the productivity of our HCV collaboration with Roche and our communications with the FDA. We are currently focused on planning a 12-week Phase 2b combination study of R7128 with Pegasys plus Copegus, continuing clevudine HBV patient enrollment and nominating a lead preclinical candidate from our proprietary HCV discovery efforts.”
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 oral treatment for chronic HCV infection, is in a 4-week Phase 1 clinical trial in combination with Pegasys plus Copegus 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 or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that we will fail to present final safety and efficacy data from a Phase 1, Part 3 multiple ascending dose study, the risk that we cannot enroll enough patients for the Phase 3 registration clinical trial for clevudine, the risk that we will fail to initiate a Phase 2b combination study of R7128 with Pegasys plus Copegus in the fourth calendar quarter 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 of Pharmasset, Inc., +1-609-613-4125,
alan.roemer@pharmasset.com
Web site: http://www.pharmasset.com/
