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VRUS Reports FY3Q07 Results

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http://biz.yahoo.com/prnews/070809/clth101.html?.v=40

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Thursday August 9, 4:30 pm ET

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, reported its unaudited financial results for the third fiscal quarter and nine months ended June 30, 2007. For the three months ended June 30, 2007, Pharmasset reported a net loss attributable to common stockholders of $7.1 million, or $0.40 per share, as compared to a net loss attributable to common stockholders of $4.4 million, or $0.42 per share for the same period in 2006. For the nine months ended June 30, 2007, Pharmasset reported a net loss attributable to common stockholders of $5.2 million, or $0.40 per share, as compared to a net loss attributable to common stockholders of $8.7 million, or $0.83 per share for the same period in 2006.

Revenues were $0.5 million during the third fiscal quarter ended June 30, 2007, primarily consisting of the amortization of payments received from Roche from the hepatitis C virus (HCV) collaboration agreement that were previously recorded as deferred revenue. Revenues for the same period in 2006 were also $0.5 million. Revenues increased to $14.0 million during the nine months ended June 30, 2007 from $4.9 million during the same period in 2006. This $9.1 million increase from the year ago period was primarily due to the receipt of milestone payments from Roche totaling $12.5 million during the first half of fiscal 2007.

Total costs and expenses for the third fiscal quarter ended June 30, 2007 were $7.1 million as compared to $5.0 million for the same period in 2006. Total costs and expenses for the nine months ended June 30, 2007 were $19.0 million as compared to $14.0 million for the same period in 2006. The increased operating expenses for both the three months and nine months ended June 30, 2007 were primarily the result of an increase in registration clinical trial expenses for clevudine, a Phase 3 clinical candidate for the treatment of chronic hepatitis B virus (HBV) infection, as well as depreciation, non-cash stock compensation and drug discovery expenses.

At June 30, 2007, Pharmasset held $65.3 million in cash and cash equivalents and approximately $1.3 million of short-term investments. In July 2007, Pharmasset received a $7.5 million milestone payment from Roche upon their initiation of long-term chronic toxicology studies in two animal species as part of a collaboration for the development of R7128 for the treatment of chronic HCV infection.

"Pharmasset continues to make progress toward our clinical program objectives with a focus on building shareholder value," stated Schaefer Price, Pharmasset's President & CEO. "In the near future, we look forward to initiating enrollment for the clevudine Phase 3 clinical trials for registration in the Americas and Europe and to reporting preliminary safety and efficacy data following 14 days of monotherapy with R7128, a potent HCV inhibitor being developed through our collaboration with Roche."

Recent Highlights

-- Completed an initial public offering (IPO) of 5,050,000 shares of its common stock at a price of $9.00 per share. Net cash proceeds from the IPO were $39.0 million.

-- Received a $7.5 million milestone payment from Roche as part of a collaboration for the development of R7128 for the treatment of chronic HCV infection.

-- Completed patient enrollment of a Phase 1 multiple ascending dose study of R7128 in 40 patients chronically infected with HCV.

-- Demonstrated in vitro that clevudine does not inhibit human immunodeficiency virus (HIV), does not result in new resistance mutations and thus may be useful for the treatment of HIV/HBV co- infected patients.

-- Confirmed Racivir's antiviral activity in treatment-experienced HIV patients with the M184V resistance mutation and less than three thymidine analog mutations.

Anticipated Highlights

-- Initiation of clevudine Phase 3 registration clinical trial enrollment in the third calendar quarter of 2007.

-- Release of R7128 preliminary safety and efficacy data from a Phase 1 multiple ascending dose study following 14 days of monotherapy in September 2007.

-- Presentation of R7128 safety and pharmacokinetic data from a Phase 1 single ascending dose study at the 14th International Symposium on Hepatitis C Virus and Related Viruses being held from September 9-13, 2007.

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 expected to enter Phase 3 clinical trials for registration in the Americas and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, is in a Phase 1 clinical trial 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.
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