Biotech Values

[DewDiligence]

VRUS Reports FY2Q09 Results

[VRUS is well capitalized: cash on hand at 3/31/09 was $79.3M, thanks to the $43.5M proceeds from a financing in Jan 2009 (#msg-35234913). News-flow guidance for 2H09 includes: i) the selection of one or more HCV purine analogs to complement R7128 or PSI-7851 in a Truvada-like oral backbone for HCV (note: R7128 a pyrimidine analog); and ii) reporting data from the phase-1 trial of PSI-7851 that started in March 2009 (#msg-36685948). VRUS does not hold quarterly CC’s. Please see actual PR for financial tables.]

http://finance.yahoo.com/news/Pharmasset-Reports-Fiscal-prnews-15206925.html

›Monday May 11, 2009, 4:43 pm EDT

PRINCETON, N.J., May 11 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS ), 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:

* On April 25, 2009, Pharmasset, Roche, and InterMune reported results from the INFORM-1 trial as an oral late breaker at the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark. This is the first study to investigate the activity of a combination of two oral antiviral molecules to treat HCV in the absence of interferon. The study is investigating the combination of Pharmasset's R7128, a nucleoside inhibitor, with InterMune's R7227, a protease inhibitor;

* On April 24, 2009, Pharmasset announced that its development partner, Roche, had initiated dosing of patients in the phase 2b trial of R7128 in combination with the standard of care in genotype 1 and 4 HCV infected patients. The start of the trial triggered a $10.0 million milestone payment to Pharmasset that is expected to be received in the quarter ending June 30, 2009;

* On April 20, 2009, Pharmasset announced that it had voluntarily halted its phase 3 registration studies of clevudine for the treatment of chronic hepatitis B infection;

* On March 31, 2009, Pharmasset announced the dosing of the first healthy volunteer in the phase 1 trial with PSI-7851, a second generation nucleotide inhibitor of HCV.

"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:

* Announce selection of candidate(s) from our purine series of nucleos(t)ide analog for HCV in second half of 2009;

* Provide update on safety from first 100 patients in the Phase 2b with Roche in second half of 2009;

* Report phase 1 antiviral data with PSI-7851 in second half of 2009;

* Report further data from INFORM-1 trial in fourth quarter of 2009.

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® 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.‹