United States
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
April 27, 2011
Pain Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
000-29959 |
91-1911336 |
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(State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
(650) 624-8200
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): |
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[ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
[ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On April 27, 2011 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Exhibit 99.1. Press release dated April 27, 2011
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Pain Therapeutics, Inc. |
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Dated: April 27, 2011 | /s/ PETER S. RODDY Peter S. Roddy Vice President & Chief Financial Officer |
EXHIBIT 99.1
- REMOXY Still On-Track for June 23 PDUFA Date -
- Cash Position Increased to $98.5 Million -
- No Change to Financial Guidance for 2011 -
SAN MATEO, Calif., April 27, 2011 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the first quarter of 2011, which ended March 31, 2011.
Quarterly financial highlights included:
"We are pleased to report another quarter that reflects strong internal fiscal discipline," commented Pete Roddy, Vice President and Chief Financial Officer.
Pain Therapeutics believes that its flagship drug candidate, REMOXY®, can generate meaningful revenue after its commercial launch by Pfizer, Inc. (NYSE:PFE) based on the sheer size of the market, Pfizer's marketing heft and strong presence in pain management, the potential advantages of REMOXY over existing products and the Company's 15-20% royalty on net sales in the U.S.
"We remain deeply committed to combat the ever-growing problem of prescription drug abuse," said Remi Barbier, Chairman, President & CEO. "I think prospects are good that abuse-resistant formulations can become an integral part of a broad set of solutions that address drug abuse."
Additional Highlights:
Q1 2011 Financial Detail
REMOXY
Our lead drug candidate, REMOXY, is a twice daily, long-acting formulation of oral oxycodone for moderate to severe pain requiring continuous, around-the-clock opioid treatment for an extended period of time. We developed this drug candidate to help address the growing problem of non-medical use of prescription opioids. REMOXY is designed to provide steady, around-the-clock pain relief, while resisting common methods of tampering intended to result in the rapid release of oxycodone.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, we have three drug candidates in clinical programs, including abuse-resistant formulations of hydromorphone, hydrocodone and oxymorphone. We are also developing a monoclonal antibody to treat metastatic melanoma and are working on a new treatment for patients with hemophilia, a genetic disorder in which patients are unable to stop bleeding.
For more information, please visit www.paintrials.com.
The term "abuse-resistant" as used in this announcement is not intended to designate an indication or a medical claim but rather a general description of agents designed to address the misuse, abuse and diversion of opioids. The FDA has not approved any of our drug candidates for commercial sale.
REMOXY® is a registered trademark of Pain Therapeutics, Inc.
Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Pain Therapeutics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to our cash usage in 2011, the completion of the regulatory review and potential approval of REMOXY, the potential for revenue from REMOXY (including statements relating to the expected market size, marketing capabilities of Pfizer and advantages of REMOXY over existing products), the use and market acceptance of abuse resistant formulations, our spending on our pipeline of drug candidates, funding obligations of our partners, and presentation of results of at future conferences. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing and pursuit of regulatory approval of our drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of our drug candidates, difficulties or delays in commercialization efforts with respect to our products, if any are approved for marketing, or failure of such products to gain market acceptance, the uncertainty of patent protection for our intellectual property or trade secrets, unanticipated additional research and development and other costs, the timing and receipt of funds from King, potential diversion of resources from the pursuit of development and commercialization of drug candidates subject to our strategic alliance with King as a result of the acquisition of King by Pfizer, the potential for abuse resistant pain medications or other competing products or therapies to be developed by competitors and potential competitors or others. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the Securities and Exchange Commission.
- Financial Tables Follow -
PAIN THERAPEUTICS, INC. | ||
CONDENSED STATEMENTS OF OPERATIONS | ||
(in thousands, except per share amounts) | ||
(Unaudited) | ||
Three Months Ended March 31, | ||
2011 | 2010 | |
Revenue | ||
Program fee revenue | $ 2,724 | $ 2,524 |
Collaboration revenue | 512 | 725 |
Total revenue | 3,236 | 3,249 |
Operating expenses | ||
Research and development | 2,178 | 3,127 |
General and administrative | 1,537 | 1,486 |
Total operating expenses | 3,715 | 4,613 |
Operating loss | (479) | (1,364) |
Interest income | 272 | 344 |
Net loss | $ (207) | $ (1,020) |
Net loss per share - basic and diluted | $ (0.00) | $ (0.02) |
Weighted-average shares used in computing net loss per share - basic and diluted |
43,124 | 42,410 |
CONDENSED BALANCE SHEETS | ||
March 31, | December 31, | |
2011 | 2010(1) | |
Assets | (Unaudited) | |
Current assets | ||
Cash, cash equivalents and marketable securities | $ 98,477 | $ 91,226 |
Receivables | 1,996 | 7,114 |
Other current assets | 84 | 144 |
Total current assets | 100,557 | 98,484 |
Non-current assets | ||
Property and equipment, net | 232 | 285 |
Other assets | 437 | 426 |
Total assets | $ 101,226 | 99,195 |
Liabilities and stockholders' equity | ||
Current liabilities | ||
Accounts payable and accrued development expenses | $ 871 | $ 1,365 |
Deferred program fee revenue - current portion | 10,897 | 10,897 |
Other accrued liabilities | 1,593 | 1,809 |
Total current liabilities | 13,361 | 14,071 |
Non-current liabilities | ||
Deferred program fee revenue - non-current portion | 49,036 | 51,760 |
Other liabilities | 432 | 431 |
Total liabilities | 62,829 | 66,262 |
Stockholders' equity | ||
Common stock | 44 | 43 |
Additional paid-in-capital | 167,684 | 161,957 |
Accumulated other comprehensive income | 468 | 525 |
Accumulated deficit | (129,799) | (129,592) |
Total stockholders' equity | 38,397 | 32,933 |
Total liabilities and stockholders' equity | $ 101,226 | $ 99,195 |
(1) Derived from the Company's annual financial statements as of December 31, 2010, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission. |
CONTACT: Judy Ishida Administrative Manager Pain Therapeutics, Inc. IR@paintrials.com 650-645-1924