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 24, 2013
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): |
||
| [ ] | 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 24, 2013 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 24, 2013
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 24, 2013 | /s/ PETER S. RODDY Peter S. Roddy Vice President & Chief Financial Officer |
| Exhibit Index | ||
| 99.1 | Press release dated April 24, 2013 | |
EXHIBIT 99.1
AUSTIN, Texas, April 24, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the quarter ended March 31, 2013. Net loss for Q1 2013 was $408,000, or $0.01 per share in Q1 2013, compared to a net profit of $30,000, or $0.00 per share in Q1 2012.
Cash and investments were $54.4 million at March 31, 2013. We continue to expect net cash usage for the first half of 2013 to be under $5.0 million. We have no debt.
"Pfizer met with the FDA on March 28, 2013, to discuss REMOXY," said Remi Barbier, Chairman, President & CEO. "Shortly, we expect to receive written information from Pfizer regarding the outcome of this meeting. I expect this information may guide a timetable for the future of REMOXY."
Q1 2013 Financial Detail
About REMOXY
Our lead drug candidate is called REMOXY® (oxycodone) Extended-Release Capsules CII. REMOXY is an investigational drug with a unique, controlled release formulation of oxycodone for patients with moderate-to-severe chronic pain. REMOXY is designed to discourage common methods of tampering associated with prescription drug misuse and abuse.
REMOXY Deal Economics
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 receipt of feedback from Pfizer about its meeting with the FDA regarding REMOXY; the expected benefits and uses of such feedback; the potential for Pfizer to address the issues outlined in the June 2011 Complete Response Letter to the REMOXY NDA; the company's projected cash requirements for the first half of 2013; 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, litigation 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; 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 March 31, | ||
| 2013 | 2012 | |
| Revenue | ||
| Program fee revenue | $ 1,958 | $ 2,724 |
| Collaboration revenue | -- | 249 |
| Total revenue | 1,958 | 2,973 |
| Operating expenses | ||
| Research and development | 1,183 | 1,609 |
| General and administrative | 1,218 | 1,512 |
| Total operating expenses | 2,401 | 3,121 |
| Operating loss | (443) | (148) |
| Interest income | 35 | 178 |
| Net income (loss) | $ (408) | $ 30 |
| Net income (loss) per share, basic and diluted | $ (0.01) | $ 0.00 |
| Weighted-average shares used in computing net income (loss) per share | ||
| Basic | 44,932 | 44,732 |
| Diluted | 44,932 | 44,756 |
| CONDENSED BALANCE SHEETS | ||
| (in thousands) | ||
|
March 31, 2013 |
December 31, 2012(1) |
|
| (Unaudited) | ||
| Assets | ||
| Current assets | ||
| Cash, cash equivalents and marketable securities | $ 54,391 | $ 56,254 |
| Other current assets | 127 | 253 |
| Total current assets | 54,518 | 56,507 |
| Non-current assets | ||
| Other assets | 352 | 352 |
| Total assets | $ 54,870 | $ 56,859 |
| Liabilities and stockholders' equity | ||
| Current liabilities | ||
| Accounts payable and accrued development expenses | $ 748 | $ 1,290 |
| Deferred program fee revenue - current portion | 7,832 | 7,832 |
| Other accrued liabilities | 1,114 | 877 |
| Total current liabilities | 9,694 | 9,999 |
| Non-current liabilities | ||
| Deferred program fee revenue - non-current portion | 31,329 | 33,287 |
| Other liabilities | 437 | 437 |
| Total liabilities | 41,460 | 43,723 |
| Stockholders' equity | ||
| Common Stock and additional paid-in-capital | 149,468 | 148,783 |
| Accumulated other comprehensive income | 1 | 4 |
| Accumulated deficit | (136,059) | (135,651) |
| Total stockholders' equity | 13,410 | 13,136 |
| Total liabilities and stockholders' equity | $ 54,870 | $ 56,859 |
| (1) Derived from the Company's annual financial statements as of December 31, 2012, 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