Pharmasset Reports Fiscal First Quarter 2011 Financial Results

PRINCETON, N.J., Feb. 7, 2011 /PRNewswire/ -- 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 December 31, 2010.

Financial Results

Revenues were $0.2 million during the quarter ended December 31, 2010 compared to $0.3 million for the quarter ended December 31, 2009 and include amortization of up-front and subsequent collaborative and license payments received from Roche.

Net cash used in operating activities during the three months ended December 31, 2010 was $24.0 million. Pharmasset held $102.7 million in cash and cash equivalents as of December 31, 2010. On January 26, 2011, we completed a common stock offering raising an additional $123.4 million.

Total operating expenses for the quarter ended December 31, 2010 were $23.8 million as compared to $13.4 million for the same period in 2009. The increase in operating expenses for the quarter ended December 31, 2010 was primarily the result of preclinical and clinical trial costs for PSI-7977 and PSI-938 of which $5.9 million was related to API manufacturing (and related drug supply) costs and pegylated interferon and ribavirin costs for the studies of PSI-7977 and PSI-938.

Pharmasset reported a net loss of $23.5 million, or $0.69 per share, for the quarter ended December 31, 2010, as compared to a net loss of $13.9 million, or $0.49 per share, for the quarter ended December 31, 2009.

Recent Operational Highlights:

-- Presented final Phase 2a results with PSI-7977 at the American Association for the Study of Liver Diseases (AASLD) in October 2010

-- Initiated Part 2 of a Phase 1 study that includes combinations of PSI-7977 and PSI-938

-- Roche reported 12 week interim results from the PROPEL study at AASLD 2010

-- Initiated the exploratory interferon sparing ELECTRON trial with PSI-7977 in genotype 2 or 3 HCV infected patients

-- Reported positive 12 week safety and efficacy results from the PROTON trial in genotype 2 or 3 patients

-- Reported 7 and 14 day monotherapy results with PSI-938

-- Announced a clinical collaboration with Bristol-Myers Squibb to investigate the combination of PSI-7977 and BMY-790052 in genotype 1, 2 or 3 treatment naïve HCV patients.

-- Completed a common stock offering raising $123.4 million in net proceeds.

"We continue to make good progress with all of our nucleotide analog programs for HCV," stated Schaefer Price, President and Chief Executive Officer. "We have maintained the momentum of 2010 into 2011 by initiating the interferon sparing ELECTRON trial, as well as a 7977 and 938 combination trial. As we look to better define the role of nucleotide analogs in the future treatment of HCV, we and our partners are planning three interferon-free studies in the first half of 2011, including our own proprietary nucleotide analog combination trial with 7977 and 938. While other DAA combination trials have been impacted by the development of resistance, our nucleotide analog trials continue to demonstrate good antiviral activity, safety and a high barrier to resistance."

Calendar Year 2011 Anticipated Milestones:

-- Pharmasset expects to report SVR12 data from its ongoing Phase 2b PROTON trial with PSI-7977 in HCV genotype 2/3 patients in the second quarter of 2011

-- Pharmasset expects to report the 12 week interim analysis from its PROTON trial genotype 1 arms in the second quarter of 2011

-- Pharmasset expects to initiate a Phase 2b trial exploring up to 24 week durations of PSI-7977 and pegylated interferon and ribavirin in the second quarter of 2011

-- Pharmasset expects to initiate a Phase 2 combination study with PSI-7977 and PSI-938 in mid-2011

-- Bristol-Myers Squibb is anticipated to initiate a combination trial of PSI-7977 and BMY-790052 during the first half of 2011

-- Pharmasset plans to submit an IND for PSI-661 in the first quarter of 2011 and to initiate a phase 1 trial in the second quarter of 2011

-- Roche expects to initiate INFORM-SVR with RG7128 and RG7227 in the first quarter of 2011

-- Roche expects to initiate a Phase 2 study with RG7128 in HCV genotype 2/3 patients in the first half of 2011

-- Roche expects to initiate a Phase 3 program with RG7128 in 2011 and file in 2013

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). 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 three clinical-stage product candidates. RG7128, a cytosine nucleoside analog for chronic HCV infection, is in two Phase 2b clinical studies in combination with Pegasys® plus Copegus® and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys® and Copegus® 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 initiated dosing in two Phase 2b studies in patients with HCV genotypes 1, 2, or 3, and PSI-938, an unpartnered guanosine nucleotide analog which recently completed a 14-day monotherapy study and has recently initiated a 14-day combination study with PSI-7977. We also have in our pipeline an additional purine nucleotide analog, PSI-661, in advanced preclinical development.

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 that are not historical facts are "forward-looking 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, 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.

SOURCE Pharmasset, Inc.