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Pharmasset Reports First Fiscal Quarter 2008 Financial Results

PRINCETON, N.J., Feb. 14 /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 first fiscal quarter of 2008 ended December 31, 2007. Pharmasset reported a net loss attributable to common stockholders of $12.2 million, or ($0.57) per share for the first fiscal quarter of 2008, as compared to net income attributable to common stockholders of $3.6 million, or $0.33 per diluted share for the same period in fiscal 2007.

Revenues were $0.5 million during the first fiscal quarter of 2008, which consisted 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 fiscal 2007 were $8.1 million, which included a $7.5 million milestone payment received from Roche. Investment income was $0.9 million during the first fiscal quarter of 2008 compared to $0.4 million during the same period in 2007. The $0.5 million increase in the first fiscal quarter of 2008 was due to higher average invested cash balances.

Total costs and expenses for the first fiscal quarter of 2008 were $13.2 million as compared to $4.6 million for the same period in fiscal 2007. The $8.6 million increase in operating expenses for the first fiscal quarter of 2008 was primarily due to a $7.0 million increase in Phase 3 registration clinical trial expenses for clevudine for the treatment of chronic hepatitis B virus (HBV) infection, as well as approximately $1.6 million in drug discovery, compensation, insurance, audit and non-cash stock compensation expenses. Interest expense was $0.4 million during the first fiscal quarter of 2008 compared to $1,800 during the same period in fiscal 2007. The increase was primarily due to interest paid on the $10.0 million of long-term debt we incurred during October 2007.

At December 31, 2007, Pharmasset held $61.5 million in cash and cash equivalents and approximately $1.3 million of short-term investments.

"We collected preliminary results of the R7128 combination study for the treatment of HCV in the first fiscal quarter of 2008, and we look forward to orally presenting the final results of these two cohorts at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) in April 2008," stated Schaefer Price, Pharmasset's Chief Executive Officer. "The rapid advancement of the R7128 program is a tribute to the productivity of our HCV collaboration with Roche and our communications with the FDA. We are currently focused on planning a 12-week Phase 2b combination study of R7128 with Pegasys plus Copegus, continuing clevudine HBV patient enrollment and nominating a lead preclinical candidate from our proprietary HCV discovery efforts."

First Fiscal Quarter 2008 Highlights

-- Commenced and subsequently completed dosing two cohorts in 4-week

combination study of R7128 with Pegasys(R) plus Copegus(R) for the

treatment of HCV.

-- Received fast track designation from the FDA for R7128 for the

treatment of HCV.

-- Entered antiviral research collaboration with the University of

Cincinnati's Genome Research Institute.

-- Appointed Michael Rogers as Chief Development Officer and Patrick T.

Higgins as Executive Vice President, Marketing & Sales.

-- Presented R7128 Phase 1 single ascending dose and 14-day monotherapy

study results for the treatment of HCV.

-- Discovered a new series of proprietary nucleoside analogs that have

demonstrated potent anti-HCV activity.

Anticipated Highlights

-- Oral presentation of the final safety and efficacy data from two

cohorts from the third part of a Phase 1 study of R7128 following 4

weeks of combination therapy with Pegasys plus Copegus at the 43rd

Annual Meeting of the European Association for the Study of the Liver

(EASL) being held from April 23-27, 2008 in Milan, Italy.

-- Complete HBV patient enrollment for clevudine Phase 3 registration

clinical trials in the second calendar half of 2008.

-- Initiate HCV patient screening for a 12-week Phase 2b combination

study of R7128 with Pegasys plus Copegus in the fourth calendar

quarter of 2008, assuming the successful completion of the on-going

R7128 Phase 1 study, transfer of our IND for R7128 to Roche, consent

from the FDA and timely completion of all required Phase 2b study

preparation activities.

-- Conducting preclinical studies of a proprietary anti-HCV nucleoside

analog to support first-in-human clinical trials, once a lead compound

has been nominated from the series.

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 enrolling Phase 3 clinical trials for registration in North, Central and South America and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, is in a 4-week Phase 1 clinical trial in combination with Pegasys plus Copegus 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.


Alan Roemer, Vice President

Investor Relations & Corporate Communications

Office: (609) 613-4125

Pegasys(R) and Copegus(R) are registered trademarks of Roche.

Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that we will fail to present final safety and efficacy data from a Phase 1, Part 3 multiple ascending dose study, the risk that we cannot enroll enough patients for the Phase 3 registration clinical trial for clevudine, the risk that we will fail to initiate a Phase 2b combination study of R7128 with Pegasys plus Copegus in the fourth calendar quarter of 2008, the risk that our collaboration with Roche will not continue or will not be successful and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Annual Report on Form 10-K for the fiscal year ended September 30, 2007 filed with the Securities and Exchange Commission entitled "Risk Factors" and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.




Three Months Ended

December 31,


2007 2006


REVENUES $464,291 $8,116,584



Research and development 10,550,371 2,561,485

General and administrative 2,619,745 2,055,038


Total costs and expenses 13,170,116 4,616,523


OPERATING INCOME (LOSS) (12,705,825) 3,500,061

INVESTMENT INCOME 896,402 408,986

INTEREST EXPENSE (363,176) (1,841)


INCOME (LOSS) BEFORE INCOME TAXES (12,172,599) 3,907,206



NET INCOME (LOSS) (12,172,599) 3,907,206


ACCRETION - 284,197



TO COMMON STOCKHOLDERS $(12,172,599) $3,623,009



NET INCOME (LOSS) $(12,172,599) $3,907,206




COMPREHENSIVE NET INCOME (LOSS): $(12,172,599) $3,909,401




BASIC $(0.57) $0.35

DILUTED $(0.57) $0.33



BASIC 21,263,668 10,504,693

DILUTED 21,263,668 11,009,257



As of

December 31, As of

2007 September 30,

(unaudited) 2007




Cash and cash equivalents $61,464,961 $68,745,694

Short-term investments 1,252,113 1,252,113

Amounts due under collaborative

agreements 1,764,828 919,110

Prepaid expenses and other assets 1,700,240 783,311


Total current assets 66,182,142 71,700,228



Laboratory, office furniture and

equipment 2,863,244 2,462,647

Leasehold improvements 1,836,553 1,836,553


4,699,797 4,299,200

Less accumulated depreciation and

amortization (1,674,095) (1,437,080)


Total equipment and

leasehold improvements, net 3,025,702 2,862,120

OTHER ASSETS 487,793 1,282,051


TOTAL $69,695,637 $75,844,399




Accounts payable $1,709,847 $3,281,600

Accrued expenses 3,007,366 5,513,407

Deferred rent 124,462 124,462

Current portion of capital lease

obligation 162,265 159,440

Deferred revenue 1,857,136 1,857,136


Total current liabilities 6,861,076 10,936,045

DEFERRED RENT 172,883 204,256



DEFERRED REVENUE 5,261,840 5,726,131

LONG-TERM DEBT 9,520,800 -


Total liabilities 21,816,599 16,908,073




Common Stock, $0.001 par value,

100,000,000 shares authorized,

21,288,614 and 21,232,991 shares

issued and outstanding at

December 31, 2007 and

September 30, 2007, respectively 21,289 21,233

Warrants to purchase 66,390 shares of

common stock for $12.05 per share,

exercisable starting

September 30, 2007 526,720 526,720

Additional paid-in capital 116,633,456 115,518,201

Accumulated other comprehensive

income 4,405 4,405

Accumulated deficit (69,306,832) (57,134,233)


Total stockholders' equity 47,879,038 58,936,326


TOTAL $69,695,637 $75,844,399


SOURCE Pharmasset, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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