Pharmasset Reports Fiscal First Quarter 2010 Financial Results
PRINCETON, N.J., Feb. 9 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS), a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the fiscal quarter ended December 31, 2009.
Financial Results
Revenues were $0.3 million during the quarter ended December 31, 2009 compared to $0.5 million for the quarter ended December 31, 2008 and reflect the amortization of up-front and subsequent collaborative and license payments received from Roche.
Net cash used in operating activities was $14.5 million for the quarter ended December 31, 2009 as compared to $15.3 million for the quarter ended December 31, 2008. Pharmasset held $42.3 million in cash and cash equivalents at the end of the fiscal first quarter.
Total operating expenses for the quarter ended December 31, 2009 were $13.4 million as compared to $18.1 million for the same period in 2008. The decrease in operating expenses for the quarter ended December 31, 2009 was primarily the result of a decrease in clinical development expenses for clevudine, our discontinued hepatitis B virus (HBV) product candidate.
Pharmasset reported a net loss of $13.9 million, or $0.49 per share, for the quarter ended December 31, 2009, as compared to a net loss of $18.3 million, or $0.78 per share, for the quarter ended December 31, 2008.
Recent Highlights:
-- On November 23, 2009, Pharmasset announced the continued enrollment of the RG7128 Phase 2b trial in treatment-naive HCV genotype 1 and 4 patients following a scheduled safety and efficacy review by an independent data monitoring committee
-- On January 21, 2010, Pharmasset announced the initiation of a phase 2a trial with PSI-7977, an isomer of PSI-7851
-- On February 2, 2010, Pharmasset completed a public offering that raised net proceeds of approximately $32.7 million.
"Pharmasset continues to make solid progress across all of its clinical programs." stated Schaefer Price, President and Chief Executive Officer. "2010 is shaping up to be an important year for the company with phase 2a data from our proprietary PSI-7977 program and phase 1 data with our first purine analog, PSI-938, coming in the third quarter. We believe nucleoside/tide analogs have the potential to become the backbone of treatment regimens, not only for genotype 1, but also across a broad range of HCV genotypes. We look forward to reporting data from all our programs throughout 2010."
Calendar Year 2010 Anticipated Milestones:
-- Roche has initiated a 24 week Phase 2b study with RG7128 in combination with pegylated interferon and ribavirin
-- Roche anticipates completion of enrollment of the RG7128 Phase 2b trial by the end of the first quarter of 2010
-- Roche expects to initiate INFORM-2 in the first quarter of 2010
-- Roche expects to initiate longer duration INFORM studies to investigate SVR in the first half of 2010
-- Roche expects to initiate an RG7128 Phase 2 study in HCV GT2 and GT3 patients in the second half of 2010
-- Pharmasset anticipates reporting topline data from its 28-day Phase 2a study with PSI-7977 in the third quarter of 2010
-- Pharmasset expects to initiate a PSI-7977 Phase 2b program in the second half of 2010
-- Pharmasset expects to submit an IND or foreign regulatory equivalent for PSI-938 in the first quarter of 2010 with topline phase 1 data available in the third quarter of 2010
-- Pharmasset expect to submit an IND or foreign regulatory equivalent for its next purine nucleotide, PSI-879 in the fourth quarter of 2010
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 C virus (HCV) and, secondarily, on the development of Racivir™ for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates. RG7128, a nucleoside analog for chronic HCV infection, is in two Phase 2b clinical trials in combination with Pegasys® plus Copegus® and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys® and Copegus® to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage candidates include PSI-7977, an isomer of PSI-7851, an unpartnered, next generation HCV nucleotide analog that is in a Phase 2a trial, and Racivir, for the treatment of HIV, which has completed a Phase 2 clinical trial. We also have two purine nucleotide analogs, PSI-938 and PSI-879, in advanced preclinical development.
Pegasys® and Copegus® are registered trademarks of Roche.
Contact |
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Richard E. T. Smith, Ph.D. |
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VP, Investor Relations and Corporate Communications |
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Office: +1 (609) 613-4181 |
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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 the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, 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 and other 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, 2009 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.
PHARMASSET, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE NET LOSS
(UNAUDITED)
Three Months Ended
December 31,
------------
2009 2008
---- ----
Revenues $269 $464
---- ----
COSTS AND EXPENSES:
Research and development 9,197 14,023
General and administrative 4,239 4,069
----- -----
Total costs and expenses 13,436 18,092
------ ------
Operating Loss (13,167) (17,628)
Investment Income 4 110
Interest Expense (706) (757)
---- ----
Loss before income taxes (13,869) (18,275)
Provision for income taxes - -
---- ----
Net loss $(13,869) $(18,275)
======== ========
COMPREHENSIVE NET LOSS:
Net loss $(13,869) $(18,275)
Unrealized gain (loss) on available-for-
sale investments - 1
---- ----
Comprehensive net loss $(13,869) $(18,274)
======== ========
NET LOSS PER SHARE:
Basic $(0.49) $(0.78)
Diluted $(0.49) $(0.78)
WEIGHTED AVERAGE SHARES OUTSTANDING:
Basic 28,287,609 23,369,487
Diluted 28,287,609 23,369,487
PHARMASSET, INC.
CONDENSED BALANCE SHEETS
As of As of
December 31, September 30,
2009 2009
---- ----
(unaudited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $42,273 $58,408
Amounts due from collaboration partner 52 369
Prepaid expenses and other assets 564 1,656
--- -----
Total current assets 42,889 60,433
------ ------
EQUIPMENT AND LEASEHOLD IMPROVEMENTS:
Equipment 3,638 3,613
Leasehold improvements 1,837 1,837
----- -----
5,475 5,450
Less accumulated depreciation and
amortization (3,669) (3,419)
------ ------
Total equipment and leasehold
improvements, net 1,806 2,031
Restricted cash 100 100
Other assets 160 172
--- ---
Total $44,955 $62,736
======= =======
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Current portion of long-term debt $8,030 $7,513
Accounts payable 2,445 2,533
Accrued expenses 3,813 7,675
Deferred rent 48 80
Deferred revenue 985 985
--- ---
Total current liabilities 15,321 18,786
Deferred revenue 2,710 2,956
Long-term debt, net of discount of $376 and
$472 as of December 31, 2009 and September
31, 2009, respectively 9,834 12,096
----- ------
Total liabilities 27,865 33,838
------ ------
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Common stock, $0.001 par value, 100,000,000 shares
authorized, 28,318,573 and 28,268,004 shares issued
and outstanding at December 31, 2009, and September
30, 2009, respectively 28 28
Warrants to purchase 127,248 shares of common stock
for $12.05 per share as of December 31, 2009
and September 30, 2009, respectively 1,230 1,230
Additional paid-in capital 197,086 195,025
Accumulated deficit (181,254) (167,385)
-------- --------
Total stockholders' equity 17,090 28,898
------ ------
Total $44,955 $62,736
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SOURCE Pharmasset, Inc.
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