Pharmasset third-quarter net loss increases to $16.0 million

Aug 10 2010

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