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)
October 31, 2013
Pain Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
000-29959 |
91-1911336 |
||
(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 October 31, 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 October 31, 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. |
||
Dated: October 31, 2013 | /s/ PETER S. RODDY Peter S. Roddy Vice President & Chief Financial Officer |
EXHIBIT 99.1
AUSTIN, Texas, Oct. 31, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the quarter and nine months ended September 30, 2013. Net loss was $762,000, or $0.02 per share in Q3 2013, compared to a net loss of $1,550,000, or $0.03 per share in Q3 2012. Cash and investments were $51.0 million at September 30, 2013.
"We still expect our net cash usage to be under $10 million in CY2013," said Remi Barbier, Chairman, President & CEO. "Based on recent developments, we also believe Pfizer has a robust plan to resubmit the REMOXY® NDA. Key elements of this plan include doing a bioequivalence study and an abuse-potential study using REMOXY, all of which we believe may result in a stream of technical milestones now through 2015."
Q3 2013 Financial Detail
About REMOXY
Our lead drug candidate, REMOXY, is an extended-release oral formulation of oxycodone for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. We designed REMOXY to discourage common methods of tampering and misuse.
Pfizer, Inc. (NYSE:PFE) is our exclusive, worldwide commercial partner for REMOXY® (oxycodone) Extended-Release Capsules CII, except as to Australia and New Zealand.
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 the company's projected cash usage for 2013; Pfizer's development plan, including expected studies, and the timing of any complete response submission for REMOXY; potential future milestone payments and royalties under the strategic alliance with Pfizer based on milestones and on revenue from REMOXY; the potential development of other abuse-resistant drug candidates; and funding obligations of Pfizer under the strategic alliance. 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 carrying out additional studies relating to, and 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; possible decisions by Pfizer to delay or not continue, or to devote less resources to, the development of REMOXY; 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; 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 September 30, | Nine Months Ended September 30, | |||
2013 | 2012 | 2013 | 2012 | |
Revenue | ||||
Program fee revenue | $ 1,958 | $ 2,725 | $ 5,875 | $ 8,173 |
Collaboration revenue | -- | -- | -- | 249 |
Total revenue | 1,958 | 2,725 | 5,875 | 8,422 |
Operating expenses | ||||
Research and development | 1,444 | 2,379 | 3,766 | 5,504 |
General and administrative | 1,290 | 2,001 | 3,647 | 4,975 |
Total operating expenses | 2,734 | 4,380 | 7,413 | 10,479 |
Operating loss | (776) | (1,655) | (1,538) | (2,057) |
Interest income | 14 | 105 | 67 | 405 |
Net loss | $ (762) | $ (1,550) | $ (1,471) | $ (1,652) |
Net loss per share, basic and diluted | $ (0.02) | $ (0.03) | $ (0.03) | $ (0.04) |
Weighted-average shares used in computing net loss per share, basic and diluted | 45,037 | 44,601 | 44,990 | 44,703 |
CONDENSED BALANCE SHEETS | ||||
(in thousands) | ||||
September 30, 2013 |
December 31, 2012(1) |
|||
(Unaudited) | ||||
Assets | ||||
Current assets | ||||
Cash, cash equivalents and marketable securities | $ 51,027 | $ 56,254 | ||
Other current assets | 389 | 253 | ||
Total current assets | 51,416 | 56,507 | ||
Non-current assets | ||||
Other assets | 340 | 352 | ||
Total assets | $ 51,756 | $ 56,859 | ||
Liabilities and stockholders' equity | ||||
Current liabilities | ||||
Accounts payable and accrued development expenses | $ 1,273 | $ 1,290 | ||
Deferred program fee revenue - current portion | 7,832 | 7,832 | ||
Other accrued liabilities | 550 | 877 | ||
Total current liabilities | 9,655 | 9,999 | ||
Non-current liabilities | ||||
Deferred program fee revenue - non-current portion | 27,412 | 33,287 | ||
Other liabilities | 437 | 437 | ||
Total liabilities | 37,504 | 43,723 | ||
Stockholders' equity | ||||
Common Stock and additional paid-in-capital | 151,373 | 148,783 | ||
Accumulated other comprehensive income | 1 | 4 | ||
Accumulated deficit | (137,122) | (135,651) | ||
Total stockholders' equity | 14,252 | 13,136 | ||
Total liabilities and stockholders' equity | $ 51,756 | $ 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: For More Information Contact: Peter S. Roddy Vice President and Chief Financial Officer Pain Therapeutics, Inc. proddy@paintrials.com (512) 501-2450