PRINCETON, N.J., June 11 /PRNewswire-FirstCall/ -- Pharmasset, Inc. , a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, announced today the unaudited financial results for the second fiscal quarter ended March 31, 2007. For the three months ended March 31, 2007, Pharmasset reported a net loss attributable to common shareholders of $1.7 million, or $0.16 per share, as compared to a net loss attributable to common shareholders of $0.9 million, or $0.09 per share for the same period in 2006.
Revenues were $5.5 million during the second fiscal quarter ended March 31, 2007, of which $5.0 million was from our hepatitis C virus (HCV) collaboration agreement with Roche for the initiation of our multiple ascending dose study of R7128 in HCV-infected patients. Revenues for the same period in 2006 were $3.5 million. Total costs and expenses for the second fiscal quarter ended March 31, 2007 were $7.3 million as compared to $4.8 million for the same period in 2006. The increased operating expenses in the second fiscal quarter of 2007 were primarily the result of a $2.5 million increase in research and development costs associated with registration study preparation activities and clinical drug supply for Clevudine, our Phase 3 clinical candidate for the treatment of hepatitis B virus (HBV).
As of March 31, 2007, Pharmasset held cash, cash equivalents and short- term investments of $31.3 million. On May 2, 2007, Pharmasset completed its initial public offering (IPO) of 5,000,000 shares of its common stock at price of $9.00 per share. Net cash proceeds were approximately $39.1 million, after deducting underwriting discounts, commissions and estimated offering expenses.
"Pharmasset's IPO was an important financial milestone for the company, allowing us to access the public capital required to advance our clinical development programs and build shareholder value," stated Schaefer Price, Pharmasset's President & CEO. "We look forward to initiating enrollment for our US, European and South American Phase 3 registration studies for Clevudine in the third calendar quarter of 2007. In previous clinical studies, Clevudine demonstrated sustained virologic response (SVR) for HBV, or undetectable virus 24 weeks after stopping therapy. In addition, we anticipate preliminary 14-day safety, pharmacokinetic and antiviral efficacy data for R7128, a potent HCV inhibitor being developed through our collaboration with Roche, in the second half of 2007."
Recent Highlights
-- Pharmasset began trading on the NASDAQ Global Market under the symbol
"VRUS" on April 27, 2007.
-- Pharmasset initiated a Phase 1 multiple ascending dose study of R7128
in 40 patients chronically infected with HCV genotype 1 who previously
failed interferon therapy.
-- Pharmasset completed a Phase 2 study of Racivir(R) for the treatment of
human immunodeficiency virus (HIV). Racivir demonstrated efficacy in
patients who were failing their HIV treatment regimen and had HIV with
the M184V mutation.
Anticipated Highlights
-- Racivir drug resistance profile to be presented at the 16th
International HIV Drug Resistance Workshop in June 2007.
-- Clevudine in vitro anti-HIV profile to be presented at the 16th
International HIV Drug Resistance Workshop in June 2007.
-- Clevudine Phase 3 registration study enrollment in the third calendar
quarter of 2007.
-- R7128 preliminary 14-day safety, pharmacokinetic and antiviral efficacy
data in the second calendar half of 2007.
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, which is entering US, European and South American Phase 3 registration clinical trials and is already approved for HBV in Korea and marketed by Bukwang Pharmaceuticals under the brand name Levovir; R7128, an oral treatment for HCV, in a Phase 1 clinical trial through a strategic collaboration with Hoffmann-LaRoche; and Racivir for the treatment of HIV in combination with other approved HIV drugs, which has completed a Phase 2 clinical trial.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
In addition to historical financial information, this press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performances or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward- looking statements. We describe in greater detail many of the risks that may impact management's expectations under the caption "Risk Factors" in the company's registration statement on Form S-1 filed with the Securities and Exchange Commission, as well as other filings that the company makes with the Securities and Exchange Commission.
Each of these statements is based only on current information, estimates and expectations that are inherently subject to change and involve a number of risks and uncertainties. Forward-looking statements include, but are not limited to: statements about our financial performance; anticipated operating losses, future revenues, research and development expenses; the need for additional financing or our use of proceeds from our initial public offering; product development efforts, in particular with respect to the clinical trial results and regulatory approval of Clevudine, Racivir, R7128 and dexelvucitabine; the initiation, completion or success of preclinical studies and clinical trials; clinical trial initiation and completion dates, anticipated regulatory filing dates and regulatory approval for our product candidates; the commercialization of our product candidates by our collaborators; our collaboration agreement with Roche, including potential milestone or royalty payments thereunder; our intentions regarding the establishment of collaborations or the licensing of product candidates or intellectual property; and our intentions to expand our capabilities and hire additional employees.
Any statement in this press release that is not a statement of historical fact should be considered a forward-looking statement. In some cases, you can identify forward-looking statements by terms such as "project," "believe," "anticipate," "plan," "expect," "estimate," "intend," "potential" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update or revise them.
Pharmasset, Inc.
Statement of Operations and
Comprehensive Net Loss
(Unaudited)
Three Months Ended
March 31,
2007 2006
REVENUES: $ 5,464,291 $ 3,537,894
COSTS AND EXPENSES:
Research and development 5,109,224 2,546,971
General and administrative 2,197,014 2,253,517
Total costs and expenses 7,306,238 4,800,488
OPERATING LOSS (1,841,947) (1,262,594)
INVESTMENT INCOME 390,093 605,488
INTEREST EXPENSE (5,092) -
LOSS BEFORE INCOME TAXES (1,456,946) (657,106)
PROVISION FOR INCOME TAXES - -
NET LOSS (1,456,946) (657,106)
REDEEMABLE PREFERRED
STOCK ACCRETION 286,834 276,403
NET LOSS ATTRIBUTABLE
TO COMMON STOCKHOLDERS $ (1,743,780) $ (933,509)
COMPREHENSIVE NET LOSS:
NET LOSS $ (1,456,946) $ (657,106)
UNREALIZED GAIN (LOSS) ON
AVAILABLE-FOR-SALE INVESTMENTS 230 (100,213)
COMPREHENSIVE NET LOSS $ (1,456,716) $ (757,319)
NET LOSS ATTRIBUTABLE TO
COMMON STOCKHOLDERS PER SHARE:
BASIC $ (0.16) $ (0.09)
DILUTED $ (0.16) $ (0.09)
WEIGHTED-AVERAGE
SHARES OUTSTANDING:
BASIC 10,697,702 10,475,517
DILUTED 10,697,702 10,475,517
Pharmasset, Inc.
Balance Sheet
(Unaudited)
As of
March 31,
2007
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 30,058,697
Short-term investments 1,252,438
Amounts due under collaborative agreements 464,899
Prepaid expenses and other assets 543,891
Deferred offering costs 2,443,288
Total current assets 34,763,213
EQUIPMENT AND LEASEHOLD IMPROVEMENTS:
Laboratory and office furniture and equipment 2,240,577
Leasehold improvements 1,836,553
4,077,130
Less accumulated depreciation and amortization (982,510)
Total equipment and leasehold
improvements, net 3,094,620
OTHER ASSETS 145,343
TOTAL $ 38,003,176
LIABILITIES, REDEEMABLE STOCK AND
WARRANTS AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 726,216
Accrued expenses 3,022,537
Deferred rent 124,462
Current portion of capital lease obligation 153,936
Deferred revenue 1,857,136
Total current liabilities 5,884,287
DEFERRED RENT 266,657
CAPITAL LEASE OBLIGATION 122,761
DEFERRED REVENUE 6,654,714
Total liabilities 12,928,419
REDEEMABLE STOCK AND WARRANTS:
Series B redeemable convertible preferred stock 624,977
Series C redeemable convertible preferred stock 1,996,715
Series D redeemable convertible preferred stock 13,493,722
Series R redeemable convertible preferred stock 3,832,296
Redeemable common stock 2,284,514
Total redeemable stock and warrants 22,232,224
STOCKHOLDERS' EQUITY:
Series A convertible preferred stock 2,640
Series D-1 warrants 5,411,932
Common stock 10,601
Additional paid-in capital 46,754,948
Accumulated other comprehensive income 4,730
Accumulated deficit (49,342,318)
Total stockholders' equity 2,842,533
TOTAL $ 38,003,176
