Attached files
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| 8-K - FORM 8-K - Pharmasset Inc | d8k.htm |
Exhibit 99.1
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Pharmasset, Inc. | |
| 303-A College Road East | ||
| Princeton, NJ 08540 U.S.A. | ||
| Phone: (609) 613-4100 | ||
| Fax: (609) 613-4150 | ||
| www.pharmasset.com | ||
| Nasdaq: VRUS |
Pharmasset Reports Fiscal Third Quarter 2011 Financial Results
PRINCETON, NJ – (July 25, 2011) – 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 quarter ended June 30, 2011.
Financial Results
Revenues were $0.2 million during the quarter ended June 30, 2011 compared to $0.2 million for the quarter ended June 30, 2010 and include amortization of up-front and subsequent collaborative and license payments received from Roche.
Net cash used in operating activities during the three months ended June 30, 2011 was $22.3 million. Pharmasset held $188.2 million in cash and cash equivalents as of June 30, 2011.
Total operating expenses for the quarter ended June 30, 2011 were $22.6 million as compared to $15.7 million for the same period in 2010.
Pharmasset reported a net loss of $22.6 million, or $0.60 per share, for the quarter ended June 30, 2011, as compared to a net loss of $16.0 million, or $0.50 per share, for the quarter ended June 30, 2010.
Recent Operational Highlights:
| • | Bristol-Myers Squibb initiated a combination trial with BMS-790052 and PSI-7977 |
| • | Completed enrollment of ELECTRON’s original four arms with PSI-7977 |
| • | Expanded the ELECTRON trial with the addition of three new treatment arms |
| • | We were granted a US patent (US patent 7,964,580) titled ‘Nucleoside Phosphoramidate Prodrugs’ covering PSI-7977. |
| • | Pharmasset and Tibotec announced a clinical collaboration to combine PSI-7977 and Tibotec’s TMC435, a protease inhibitor |
| • | Reported SVR24 data from PROTON trial with PSI-7977 in genotype 2 or 3 patients. |
| • | Roche disclosed that it expects to file, in 2014, an application for marketing approval of mericitabine |
“Pharmasset had a very successful first half of 2011 with a strong showing at the EASL meeting, the signing of a clinical collaboration with Tibotec and the issuance of a US patent for PSI-7977,” stated Schaefer Price, President and Chief Executive Officer. “The second half of 2011 holds a number of important clinical milestones for us, as we plan to report SVR12 data from both the PROTON and ELECTRON trials. In addition, we plan to initiate the QUANTUM study, our first SVR-focused, interferon free trial with PSI-7977 and PSI-938 in the third quarter.”
Calendar Year 2011 Anticipated Milestones:
| • | Report SVR12 data from PROTON trial with PSI-7977 in genotype 1 patients in second half 2011 |
| • | Report SVR12 data from ELECTRON trial with PSI-7977 in genotype 2 or 3 patients in second half 2011 |
| • | Initiate QUANTUM trial with PSI-7977 and PSI-938 in third quarter 2011. |
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 the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused 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 advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in four Phase 2b trials in patients with HCV genotypes 1 through 6, including abbreviated duration interferon and interferon-free regimens. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, recently reported safety and efficacy data from 14 days of monotherapy as well as 14 days in combination with the pyrimidine, PSI-7977. An SVR-endpoint study of the purine-pyrimidine combination is anticipated to begin in the third quarter of 2011. Mericitabine (RG7128) continues in three Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.
Contact
Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
Office+1 (609) 865-0693
Forward-Looking Statements
Pharmasset “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are “forward-looking statements,” that involve risks, uncertainties, and other important factors, including, without limitation, the risk of 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 risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.
PHARMASSET, INC.
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
(in thousands, except share and per share amounts)
| Three Months
Ended June 30, |
Nine Months
Ended June 30, |
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| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Revenues |
$ | 246 | $ | 249 | $ | 739 | $ | 769 | ||||||||
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| COSTS AND EXPENSES: |
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| Research and development |
18,917 | 11,505 | 54,680 | 32,731 | ||||||||||||
| General and administrative |
3,719 | 4,200 | 12,567 | 12,086 | ||||||||||||
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| Total costs and expenses |
22,636 | 15,705 | 67,247 | 44,817 | ||||||||||||
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| Operating loss |
(22,390 | ) | (15,456 | ) | (66,508 | ) | (44,048 | ) | ||||||||
| Investment income |
4 | 1 | 8 | 6 | ||||||||||||
| Other income |
— | — | 489 | — | ||||||||||||
| Interest expense |
(219 | ) | (565 | ) | (927 | ) | (1,909 | ) | ||||||||
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| Loss before income taxes |
(22,605 | ) | (16,020 | ) | (66,938 | ) | (45,951 | ) | ||||||||
| Provision (benefit) for income taxes |
— | — | (973 | ) | — | |||||||||||
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| Net loss |
$ | (22,605 | ) | $ | (16,020 | ) | $ | (65,965 | ) | $ | (45,951 | ) | ||||
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| Net loss per share: basic and diluted |
$ | (0.60 | ) | $ | (0.50 | ) | $ | (1.84 | ) | $ | (1.54 | ) | ||||
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| Weighed average shares outstanding: |
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| basic and diluted |
37,435,614 | 32,000,528 | 35,937,456 | 29,932,398 | ||||||||||||
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PHARMASSET, INC.
BALANCE SHEETS
(in thousands, except par value, share and per share amounts)
| As of June 30, 2011 |
As of September 30, 2010 |
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| (unaudited) | ||||||||
| ASSETS |
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| CURRENT ASSETS: |
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| Cash and cash equivalents |
$ | 188,226 | $ | 127,081 | ||||
| Amounts due from collaboration partner |
— | 6 | ||||||
| Prepaid expenses and other current assets |
2,078 | 718 | ||||||
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| Total current assets |
190,304 | 127,805 | ||||||
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| EQUIPMENT AND LEASEHOLD IMPROVEMENTS: |
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| Equipment |
4,767 | 4,060 | ||||||
| Leasehold improvements |
1,836 | 1,837 | ||||||
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| 6,603 | 5,897 | |||||||
| Less accumulated depreciation and amortization |
(4,547 | ) | (4,184 | ) | ||||
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| Total equipment and leasehold improvements, net |
2,056 | 1,713 | ||||||
| Restricted cash |
100 | 100 | ||||||
| Other assets |
139 | 143 | ||||||
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| Total |
$ | 192,599 | $ | 129,761 | ||||
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| LIABILITIES AND STOCKHOLDERS’ EQUITY |
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| CURRENT LIABILITIES: |
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| Current portion of long-term debt |
$ | 3,919 | $ | 8,705 | ||||
| Accounts payable |
3,353 | 5,037 | ||||||
| Accrued expenses |
6,174 | 5,863 | ||||||
| Deferred rent |
27 | 25 | ||||||
| Deferred revenue |
985 | 985 | ||||||
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| Total current liabilities |
14,458 | 20,615 | ||||||
| Deferred rent |
98 | 93 | ||||||
| Deferred revenue |
1,232 | 1,971 | ||||||
| Long-term debt, net of discount of $29 and $150 as of June 30, 2011 and September 30, 2010, respectively |
477 | 2,934 | ||||||
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| Total liabilities |
16,265 | 25,613 | ||||||
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| Commitments and contingencies |
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| STOCKHOLDERS’ EQUITY: |
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| Common stock, $0.001 par value, 100,000,000 shares authorized, 37,624,362 and 34,043,898 shares issued and outstanding at June 30, 2011 and September 30, 2010, respectively |
38 | 34 | ||||||
| Warrants to purchase 38,727 shares of common stock for $12.05 per share at June 30, 2011, and 127,248 shares of common stock for $12.05 per share at September 30, 2010 |
380 | 1,230 | ||||||
| Additional paid-in capital |
475,348 | 336,351 | ||||||
| Accumulated deficit |
(299,432 | ) | (233,467 | ) | ||||
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| Total stockholders’ equity |
176,334 | 104,148 | ||||||
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| Total |
$ | 192,599 | $ | 129,761 | ||||
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