Biotech Values

[DewDiligence]

VRUS Reports FY2Q08 Results

[For archival purposes—no new info other than the financials.]

http://biz.yahoo.com/prnews/080515/clth054a.html

>>
Thursday May 15, 4:15 pm ET

PRINCETON, N.J., May 15 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS ), a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported unaudited financial results for the second fiscal quarter ended March 31, 2008. Pharmasset reported a net loss attributable to common stockholders of $12.1 million, or ($0.57) per share for the quarter ended March 31, 2008, as compared to a net loss attributable to common stockholders of $1.7 million, or ($0.16) per share for the same period in 2007.

Revenues were $0.5 million and $5.5 million during the quarters ended March 31, 2008 and 2007, respectively. Revenues during each period reflect amortization of up-front and subsequent collaborative and license payments received from Roche previously recorded as deferred revenue of $0.5 million. Revenues from the year ago quarter also include a milestone payment of $5.0 million received pursuant to the Roche collaboration.

Total costs and expenses for the quarter ended March 31, 2008 were $12.8 million as compared to $7.3 million for the same period in 2007. The $5.5 million increase in total costs and expenses during the quarter ended March 31, 2008 was primarily due to a $2.9 million increase in Phase 3 registration clinical trial expenses for clevudine for the treatment of chronic hepatitis B virus (HBV) infection, a $1.2 million increase in compensation expense resulting from increased headcount and a $1.4 million increase in legal, insurance, audit and marketing expenses. Interest expense increased to $0.4 million during the quarter ended March 31, 2008 from $0.0 million in the quarter ended March 31, 2007. The increase was due to interest on the $10.0 million of debt incurred during October 2007.

As of March 31, 2008, Pharmasset had approximately $63.0 million of cash and cash equivalents and approximately $1.2 million of short-term investments.

"R7128 for the treatment of hepatitis C virus (HCV) continues to demonstrate best-in-class potential based on its safety, efficacy and high barrier to resistance as demonstrated in 4-week Phase 1 clinical trials," stated Schaefer Price, Pharmasset's Chief Executive Officer. "We look forward to continuing the advancement and broadening the scope of this program by exploring additional Phase 1 cohorts, including an R7128 1000mg dose in patients with HCV genotype 1 and an R7128 1500mg dose in patients with HCV genotypes 2 and 3 who have not responded to prior therapy. We and Roche are currently focused on planning a global 12-week Phase 2b combination study of R7128 with Pegasys plus Copegus."

Highlights of the Quarter Ended March 31, 2008

-- Announced preliminary safety and efficacy results of two cohorts (500mg and 1500mg) in a 4-week combination study of R7128 with Pegasys plus Copegus for the treatment of HCV.

-- Appointed Herbert J. Conrad as a member of our Board of Directors and the Nominating and Corporate Governance Committee.

-- Advanced a new series of proprietary nucleoside analogs that have demonstrated potent anti-HCV activity.

Anticipated Highlights

-- Initiating dosing and announcing preliminary results of Cohorts 3 and 4 in a 4-week combination study of R7128 with Pegasys plus Copegus for the treatment of HCV in the third calendar quarter of 2008.

-- Completing HBV patient enrollment for clevudine Phase 3 registration studies in the second calendar half of 2008. -- Initiating trial activities for a global 12-week Phase 2b combination study of R7128 with Pegasys plus Copegus in the fourth calendar quarter of 2008, assuming successful completion of the ongoing R7128 Phase 1 study, transfer of Pharmasset's IND to Roche, timely progress on agreed development timelines, completion of all required Phase 2b study preclinical and clinical preparation activities, manufacture of clinical trial drug supply and agreement on the trial design from the FDA and foreign regulatory authorities. An update will be provided as soon as additional information is available. -- Nominating a lead product candidate from a new series of potent anti HCV molecules for IND or foreign regulatory equivalent filing and first-in-human clinical trials.
<<