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)
February 9, 2012
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.) |
512-501-2444
(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 February 9, 2012 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 February 9, 2012
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: February 9, 2012 | /s/ PETER S. RODDY Peter S. Roddy Vice President & Chief Financial Officer |
EXHIBIT 99.1
– Balance Sheet Remains Strong –
– Disciplined Spending Expected in 2012 –
AUSTIN, Texas, Feb. 9, 2012 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the full year ended December 31, 2011. Net loss was $2.6 million in 2011, or $0.06 per share, compared to a net loss of $12.0 million in 2010, or $0.28 per share.
Cash and equivalents stood at $98.1 million at December 31, 2011. Net cash usage for the first half of 2012 is expected to be under $5.0 million. The Company has no debt.
"2012 may be an important year for Pain Therapeutics," said Remi Barbier, President & CEO. "We have a strong balance sheet, a history of disciplined spending and a late-stage drug asset under development by Pfizer. We also have a highly focused research and development strategy and significant management ownership of the Company. With these strengths, I think we have the potential to build a major business in biotechnology."
2011 Financial Detail
About REMOXY
Our lead drug is called REMOXY®. It is an investigational extended-release oral formulation of oxycodone for the relief of moderate to severe pain requiring continuous, around-the-clock opioid treatment. We developed REMOXY to discourage common methods of drug tampering.
On June 24, 2011, we and partner Pfizer, Inc. (NYSE:PFE) announced that a Complete Response Letter was received from the U.S. Food and Drug Administration (FDA) on the resubmission to the new drug application (NDA) for REMOXY (oxycodone) Extended-Release Capsules CII. Pfizer is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with the FDA around them. Pfizer has full control of the development and funding of REMOXY.
In 2005, we entered into a strategic alliance with King Pharmaceuticals, Inc. (King) to develop and commercialize REMOXY. We filed the initial NDA for REMOXY in June 2008 and received a Complete Response Letter in December 2008. King assumed full control of the development of REMOXY in March 2009; filed a resubmission to the REMOXY NDA in December 2010; and received a Complete Response Letter for such resubmission in June 2011. Pfizer obtained rights to REMOXY upon the close of its acquisition of King in February 2011.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. The FDA has not approved any of our drug candidates for commercial sale. For more information, please visit www.paintrials.com.
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 projected cash requirements for the first half of 2012, our potential to build a major business in biotechnology; potential future milestone payments and royalties based on revenue from REMOXY, the potential development of other abuse resistant drug candidates, and funding obligations of Pfizer. 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 obtaining regulatory approval of REMOXY and in development, testing and pursuit of regulatory approval of our other 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 Pfizer, potential diversion of resources from the pursuit of development and commercialization of drug candidates subject to our strategic alliance with Pfizer as a result of the acquisition of King by Pfizer, and 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 December 31, | Year Ended December 31, | |||
2011 | 2010 | 2011 | 2010(1) | |
Revenue | ||||
Program fee revenue | $ 2,724 | $ 2,724 | $ 10,897 | $ 10,496 |
Collaboration revenue | 23 | 285 | 587 | 1,313 |
Milestone revenue | -- | 5,000 | -- | 5,000 |
Total revenue | 2,747 | 8,009 | 11,484 | 16,809 |
Operating expenses | ||||
Research and development | 1,711 | 8,010 | 8,300 | 15,746 |
General and administrative | 1,620 | 9,510 | 6,698 | 14,766 |
Total operating expenses | 3,331 | 17,520 | 14,998 | 30,512 |
Operating loss | (584) | (9,511) | (3,514) | (13,703) |
Interest income | 193 | 340 | 901 | 1,680 |
Net loss | $ (391) | $ (9,171) | $ (2,613) | $ (12,023) |
Net loss per share - basic and diluted | $ (0.01) | $ (0.21) | $ (0.06) | $ (0.28) |
Weighted-average shares used in computing net loss per share - basic and diluted | 44,671 | 42,797 | 44,160 | 42,644 |
CONDENSED BALANCE SHEETS | ||||
December 31, | ||||
2011 | 2010(1) | |||
(Unaudited) | ||||
Assets | ||||
Current assets | ||||
Cash, cash equivalents and marketable securities | $ 98,131 | $ 91,226 | ||
Receivables | -- | 7,114 | ||
Other current assets | 358 | 144 | ||
Total current assets | 98,489 | 98,484 | ||
Non-current assets | ||||
Property and equipment, net | 122 | 285 | ||
Other assets | 352 | 426 | ||
Total assets | $ 98,963 | $ 99,195 | ||
Liabilities and stockholders' equity | ||||
Current liabilities | ||||
Accounts payable and accrued development expenses | $ 1,378 | $ 1,365 | ||
Deferred program fee revenue - current portion | 10,897 | 10,897 | ||
Other accrued liabilities | 997 | 1,809 | ||
Total current liabilities | 13,272 | 14,071 | ||
Non-current liabilities | ||||
Deferred program fee revenue - non-current portion | 40,863 | 51,760 | ||
Other liabilities | 435 | 431 | ||
Total liabilities | 54,570 | 66,262 | ||
Stockholders' equity | ||||
Common stock | 45 | 43 | ||
Additional paid-in-capital | 176,425 | 161,957 | ||
Accumulated other comprehensive income | 128 | 525 | ||
Accumulated deficit | (132,205) | (129,592) | ||
Total stockholders' equity | 44,393 | 32,933 | ||
Total liabilities and stockholders' equity | $ 98,963 | $ 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: Peter S. Roddy Vice President and Chief Financial Officer Pain Therapeutics, Inc. proddy@paintrials.com (512) 501-2450