PRINCETON, N.J., May 11 /PRNewswire-FirstCall/ -- Pharmasset, Inc. , a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, reported financial results and operational highlights for the fiscal quarter ended March 31, 2009.
Financial Results
Revenues were $1.9 million during the quarter ended March 31, 2009 compared to $0.5 million for the quarter ended March 31, 2008 and reflect the receipt of $1.4 million of research and development payments and the amortization of up-front and subsequent collaborative and license payments received from Roche.
Net cash used in operating activities was $15.5 million for the quarter ended March 31, 2009 as compared to $9.4 million for the quarter ended March 31, 2008. Pharmasset held $79.3 million in cash and cash equivalents at the end of the fiscal second quarter.
Total operating expenses for the quarter ended March 31, 2009 were $16.6 million as compared to $12.8 million for the same period in 2008. The increase in operating expenses for the quarter ended March 31, 2009 was primarily the result of an increase in phase 3 registration study expenses for clevudine for the treatment of chronic hepatitis B infection, as well as increased preclinical development expenses for our second generation hepatitis C virus (HCV) product candidate, PSI-7851, and the purine series of compounds.
Pharmasset reported a net loss of $15.5 million, or $0.59 per share for the quarter ended March 31, 2009, as compared to a net loss of $12.1 million, or $0.57 per share for the quarter ended March 31, 2008.
Recent Highlights:
“Our HCV pipeline continues to make solid progress,” stated Schaefer Price, President and Chief Executive Officer. “In April, we announced exciting data from the INFORM-1 trial at EASL and the initiation of the phase 2b trial with R7128. We are now able to increase our focus on further strengthening our portfolio of HCV nucleos(t)ides with the decision to halt registration studies with clevudine. We look forward to providing the first antiviral data on PSI-7851 in the second half of 2009.”
Calendar Year 2009 Anticipated Milestones:
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 C virus (HCV) and, secondarily, on the development of Racivir(R) for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleos(t)ide analogs, a class of compounds which act to inhibit the enzymes required for viral replication. We currently have three clinical-stage product candidates: R7128, a nucleoside analog for chronic HCV infections, has initiated a Phase 2b clinical trial in combination with Pegasys plus Copegus through a strategic collaboration with Roche; PSI-7851, an unpartnered, next generation HCV nucleotide analog, which recently began Phase 1 clinical studies and Racivir, for the treatment of HIV that has completed a Phase 2 clinical trial.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
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 the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, 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, 2008 and our Quarterly Report on Form 10-Q for the period ended March 31, 2009 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: Richard E. T. Smith, Ph.D., VP, Investor Relations and Corporate
Communications of Pharmasset, Inc., Office, +1-609-613-4181,
richard.smith@pharmasset.com
Web site: http://www.pharmasset.com/
