PRINCETON, N.J., May 15 /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 second fiscal quarter ended March 31, 2008. Pharmasset reported a net loss attributable to common stockholders of $12.1 million, or ($0.57) per share for the quarter ended March 31, 2008, as compared to a net loss attributable to common stockholders of $1.7 million, or ($0.16) per share for the same period in 2007.
Revenues were $0.5 million and $5.5 million during the quarters ended March 31, 2008 and 2007, respectively. Revenues during each period reflect amortization of up-front and subsequent collaborative and license payments received from Roche previously recorded as deferred revenue of $0.5 million. Revenues from the year ago quarter also include a milestone payment of $5.0 million received pursuant to the Roche collaboration.
Total costs and expenses for the quarter ended March 31, 2008 were $12.8 million as compared to $7.3 million for the same period in 2007. The $5.5 million increase in total costs and expenses during the quarter ended March 31, 2008 was primarily due to a $2.9 million increase in Phase 3 registration clinical trial expenses for clevudine for the treatment of chronic hepatitis B virus (HBV) infection, a $1.2 million increase in compensation expense resulting from increased headcount and a $1.4 million increase in legal, insurance, audit and marketing expenses. Interest expense increased to $0.4 million during the quarter ended March 31, 2008 from $0.0 million in the quarter ended March 31, 2007. The increase was due to interest on the $10.0 million of debt incurred during October 2007.
As of March 31, 2008, Pharmasset had approximately $63.0 million of cash and cash equivalents and approximately $1.2 million of short-term investments.
“R7128 for the treatment of hepatitis C virus (HCV) continues to demonstrate best-in-class potential based on its safety, efficacy and high barrier to resistance as demonstrated in 4-week Phase 1 clinical trials,” stated Schaefer Price, Pharmasset’s Chief Executive Officer. “We look forward to continuing the advancement and broadening the scope of this program by exploring additional Phase 1 cohorts, including an R7128 1000mg dose in patients with HCV genotype 1 and an R7128 1500mg dose in patients with HCV genotypes 2 and 3 who have not responded to prior therapy. We and Roche are currently focused on planning a global 12-week Phase 2b combination study of R7128 with Pegasys plus Copegus.”
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(R) plus 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.
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 cannot enroll enough patients for the Phase 3 registration studies for clevudine, the risk that our collaboration with Roche will not continue or will not be successful, the risk that any one or more of our product candidates will not be successfully developed and commercialized and the risk that we will not be able to further develop any of the compounds from the new series of anti-HCV molecules currently being investigated by us. 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/
