Pharmasset, Inc. Reports Fiscal Third Quarter 2010 Financial Results

PRINCETON, N.J., Aug. 9 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS), a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the quarter ended June 30, 2010.

Financial Results

Revenues were $0.2 million during the quarter ended June 30, 2010 compared to $10.5 million for the quarter ended June 30, 2009 and include amortization of up-front and subsequent collaborative and license payments received from Roche. Revenues for the quarter ended June 30, 2009, also included a $10.0 million milestone payment received from Roche for initiating a Phase 2b study of RG7128.

Net cash used in operating activities during the three months ended June 30, 2010 was $15.5 million. Net cash used in operating activities was $42.9 million for the nine months ended June 30, 2010, as compared to $36.5 million for the nine months ended June 30, 2009. Pharmasset had $144.4 million in cash and cash equivalents as of June 30, 2010.

Total operating expenses for the quarter ended June 30, 2010 were $15.7 million as compared to $16.7 million for the same period in 2009. The decrease in operating expenses for the quarter ended June 30, 2010 was primarily the result of discontinuing our clevudine program in April 2009, partially offset by increases in development costs for PSI-7977, PSI-938 and PSI-661.

Pharmasset reported a net loss of $16.0 million, or $0.50 per share, for the quarter ended June 30, 2010, as compared to a net loss of $6.9 million, or $0.25 per share, for the quarter ended June 30, 2009.

Recent Operational Highlights:

-- In May 2010, Pharmasset completed an underwritten public offering that raised net proceeds of approximately $101.2 million.

-- On July 28, 2010, Pharmasset announced that it had completed a single ascending dose trial with PSI-938 and had begun dosing in a 7 day multiple ascending dose trial in hepatitis C infected patients.

-- In July 2010, Pharmasset received notice that multiple abstracts on PSI-7977 and PSI-938 had been accepted for presentation at the 61st American Association for the Study of Liver Diseases (AASLD) meeting in Boston, MA (October 29 to November 2) . In addition, two abstracts on RG7128, submitted by Roche, discussing interim 12-week safety and efficacy data and resistance data from the phase 2b PROPEL study, were accepted for presentation at AASLD.

“We continue to make substantial advancements in the clinic with our growing pipeline of nucleoside/tide analogs for HCV,” stated Schaefer Price, President and Chief Executive Officer. “Already in 2010, we have reported interim Phase 2b results on RG7128, Phase 2a results with PSI-7977 and Phase 1 results with PSI-938. With more data to come at AASLD and the planned initiation of a Phase 2b trial with PSI-7977 in the fourth quarter, Pharmasset continues to generate a steady flow of clinical news. As we look to develop all-oral combinations of direct acting antivirals, we believe the safety, high barrier to resistance and pan-genotype activity of nucleoside/tide analogs should help position them as the backbone of future HCV treatment regimens.”

Calendar Year 2010 Anticipated Milestones:

-- Pharmasset’s partner Roche will present interim 12 week results from its Phase 2b PROPEL study at AASLD

-- Pharmasset will present Phase 2a PSI-7977 and Phase 1 PSI-938 data at AASLD

-- Pharmasset expects to initiate a 12-week Phase 2b study of PSI-7977 in the fourth quarter of 2010

-- Pharmasset expects to present Phase 1 antiviral data for PSI-938 in the fourth quarter of 2010

-- Pharmasset expects to submit an IND or foreign regulatory equivalent for its second guanosine nucleotide, PSI-661, in the fourth quarter of 2010

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(TM) for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have four clinical-stage product candidates. RG7128, a cytosine nucleoside analog for chronic HCV infection, is in two Phase 2b clinical studies in combination with Pegasys(R) plus Copegus(R) and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage HCV candidates include PSI-7977, an unpartnered uracil nucleotide analog that has recently completed 28 days of dosing in a Phase 2a study, and PSI-938, an unpartnered guanine nucleotide analog in a Phase 1 study. We also have in our pipeline an additional purine nucleotide analog, PSI-661, in advanced preclinical development. Racivir, for the treatment of HIV, has completed a Phase 2 clinical study.

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Pegasys® and Copegus® 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 that are not historical facts are “forward-looking statements,” including, without limitation, statements that involve risks, uncertainties, and other important factors, including, without limitation, the risk of 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 risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2009 and our Quarterly Reports on Form 10-Q for the periods ended December 31, 2009, March 31, 2010 and June 30, 2010 filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.