Pharmasset Reports Financial Results for Quarter Ended June 30, 2008
Thursday August 14, 4:01 pm ET
PRINCETON, N.J., Aug. 14 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News), a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported unaudited financial results for the third fiscal quarter ended June 30, 2008. Pharmasset reported a net loss attributable to common stockholders of $15.0 million, or a loss per share of $0.69 for the quarter ended June 30, 2008, as compared to a net loss attributable to common stockholders of $7.1 million, or a loss per share of $0.40 per share for the same period in 2007.
Revenues were $0.5 million during the quarters ended June 30, 2008 and 2007 and reflect amortization of up-front and subsequent collaborative and license payments received from Roche previously recorded as deferred revenue. Total costs and expenses for the quarter ended June 30, 2008 were $15.0 million, as compared to $7.1 million for the same period in 2007. The $7.9 million increase in total costs and expenses during the quarter ended June 30, 2008 was primarily due to a $5.8 million increase in Phase 3 clinical trial expenses to support registration of clevudine for the treatment of chronic hepatitis B virus (HBV) infection, a $1.0 million increase in compensation expense resulting from increased headcount, a $0.4 million increase in new drug discovery expenses, and a $0.7 million increase in marketing and other administrative expenses. Investment income decreased to $0.2 million during the quarter ended June 30, 2008 from $0.7 million in the quarter ended June 30, 2007, primarily on lower rates of return on invested balances. Interest expense increased to $0.7 million during the quarter ended June 30, 2008 from $0.0 million in the year-ago quarter. The increase was due to interest on the $20.0 million of debt incurred during October 2007 and March 2008.
As of June 30, 2008, Pharmasset had approximately $51.0 million of cash and cash equivalents and approximately $1.0 million of short-term investments.
"We have made solid progress across all aspects of our business in this last quarter. The ANRS sponsored study investigating clevudine in combination with Viread® in HBV is a very exciting study for us and reflects the potential movement of the marketplace toward combination therapy," stated Schaefer Price, Pharmasset's Chief Executive Officer. "In addition, we have made substantial progress in our HCV programs with the recent clinical data from R7128 and our nomination of PSI-7851 as a next-generation lead product candidate to be advanced into clinical development. This progress allows us to maintain a well-balanced and growing portfolio of hepatology product candidates", added Mr. Price. "We look forward to the unblinding of our R7128 genotype 2/3 patient data and hope to see data that is consistent with the antiviral activity we see in genotype 1 patients."
Highlights of the Quarter Ended June 30, 2008
-- Commenced dosing two additional cohorts of a 4-week Phase 1 study of
R7128 in combination with Pegasys® (peginterferon alfa-2a) plus
Copegus® (ribavirin) in both genotype 1 treatment-naive patients and
genotypes 2 and 3 treatment-experienced HCV patients.
-- Nominated PSI-7851 as a lead product candidate for the treatment of
HCV. PSI-7851 is a proprietary nucleotide analogue polymerase inhibitor
of HCV that is being advanced into Good Laboratory Practice (GLP)
toxicology studies.
-- Announced receipt of a Notice of Allowance from the United States
Patent and Trademark Office covering the anti-HCV drug PSI-6130 and its
active metabolites.
-- Joined the NASDAQ Biotechnology Index and the broad-market Russell 3000
Index.
Highlights since the Quarter Ended June 30, 2008
-- Announced preliminary safety and efficacy results of Cohort 3 of a 4-
week Phase 1 study of R7128 1000mg twice daily (BID) in combination
with Pegasys® plus Copegus® for the treatment of HCV, in which
patients achieved a mean 5.0 log10 IU/mL decrease in HCV RNA and 88%
(22 of 25) of patients achieved undetectable HCV RNA levels following
4 weeks of treatment with blinded safety and tolerability similar to
the safety profile observed with the standard of care alone (Pegasys®
and Copegus®).
-- Raised $24.2 million in net proceeds after deducting placement agent
fees and estimated offering expenses by selling 1,450,000 shares of
common stock to a select group of institutional investors in a
"registered direct" public offering. The net proceeds from this
offering will be used for general corporate purposes.
-- Announced initiation of a combination study of clevudine and Viread®
for HBV by the French National Agency for Research on AIDS and Viral
Hepatitis (ANRS).
Anticipated Highlights
-- Announcing preliminary results of a 4-week combination study of R7128
1500 mg BID with Pegasys® plus Copegus® in treatment-experienced
patients with HCV genotypes 2 and 3 by the end of the third calendar
quarter of 2008.
-- Completing HBV patient enrollment for clevudine Phase 3 registration
studies in the second calendar half of 2008.
-- Submitting the draft protocol and supporting documentation for our 12-
week Phase 2b combination study of R7128 with Pegasys® plus
Copegus® to the FDA during November 2008.
surf's up......crikey
