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Pharmasset Reports Financial Results for Quarter Ended March 31, 2008

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.

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


Alan Roemer, Vice President

Investor Relations & Corporate Communications

Office: (609) 613-4125

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 cannot enroll enough patients for the Phase 3 registration studies for clevudine, the risk that our collaboration with Roche will not continue or will not be successful, the risk that any one or more of our product candidates will not be successfully developed and commercialized and the risk that we will not be able to further develop any of the compounds from the new series of anti-HCV molecules currently being investigated by us. 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

March 31,


2008 2007


REVENUES: $464,292 $5,464,291



Research and development 8,990,469 5,109,224

General and administrative 3,809,073 2,197,014


Total costs and expenses 12,799,542 7,306,238


OPERATING (LOSS) INCOME (12,335,250) (1,841,947)

INVESTMENT INCOME 585,048 390,093

INTEREST EXPENSE (386,161) (5,092)


(LOSS) INCOME BEFORE INCOME TAXES (12,136,363) (1,456,946)



NET (LOSS) INCOME (12,136,363) (1,456,946)




COMMON STOCKHOLDERS $(12,136,363) $(1,743,780)



NET (LOSS) INCOME $(12,136,363) $(1,456,946)




COMPREHENSIVE NET (LOSS) INCOME: $(12,165,935) $(1,456,716)




BASIC $(0.57) $(0.16)

DILUTED $(0.57) $(0.16)


BASIC 21,379,638 10,697,702

DILUTED 21,379,638 10,697,702



As of As of

March 31, September 30,

2008 2007





Cash and cash equivalents $62,961,991 $68,745,694

Short-term investments 1,224,489 1,252,113

Amounts due under collaborative

agreements 1,477,434 919,110

Prepaid expenses and other assets 954,977 783,311


Total current assets 66,618,891 71,700,228



Laboratory, office furniture and

equipment 3,074,611 2,462,647

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


4,911,164 4,299,200

Less accumulated depreciation and

amortization (1,924,661) (1,437,080)


Total equipment and leasehold

improvements, net 2,986,503 2,862,120

OTHER ASSETS 267,163 1,282,051


TOTAL $69,872,557 $75,844,399




Current portion of long-term debt $287,481 $ -

Current portion of capital lease

obligation 122,762 159,440

Accounts payable 1,709,112 3,281,600

Accrued expenses 3,845,332 5,513,407

Deferred rent 124,462 124,462

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


Total current liabilities 7,946,285 10,936,045

DEFERRED RENT 142,194 204,256



DEFERRED REVENUE 4,797,548 5,726,131

LONG-TERM DEBT, net 18,671,040 -


Total liabilities 31,557,067 16,908,073




Common Stock, $0.001 par value,

100,000,000 shares authorized,

21,531,980 and 21,232,991 shares issued and

outstanding at March 31, 2008 (unaudited)

and September 30, 2007,

respectively 21,532 21,233

Warrants to purchase 116,183 shares

of common stock for $12.05 per share,

with 66,390 exercisable starting

September 30, 2007, and 49,793 shares

exercisable starting March 28, 2008

(unaudited) 1,140,114 526,720

Additional paid-in capital 118,622,206 115,518,201

Accumulated other comprehensive

(loss) income (25,167) 4,405

Accumulated deficit (81,443,195) (57,134,233)


Total stockholders' equity 38,315,490 58,936,326


TOTAL $69,872,557 $75,844,399


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

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