Pain Therapeutics Reports 2013 Financial Results and Provides Guidance for 2014

Pain Therapeutics Reports 2013 Financial Results and Provides Guidance for 2014  Conference Call Today at 5:00 p.m. Eastern  AUSTIN, Texas, Feb. 4, 2014 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for 2013 and provided guidance for 2014. Net profit in 2013 was $31.5 million, or $0.70 per diluted share, compared to a net loss in 2012 of $3.4 million, or $0.08 per share.  "We are excited about what lies ahead for PTIE in 2014," said Remi Barbier, President & CEO. "We'll be watching the progress of REMOXY carefully over the next few quarters, as Pfizer has stated an intent to refile an NDA mid-2015. Any moves towards risk-reduction around this drug candidate may accelerate our corporate strategy to transition from purely an R&D company to a mix of R&D and product revenue. Based on the clinical and commercial profiles of REMOXY, and potential upside of our early-stage assets, I believe 2014 may be a pivotal year for us."  We expect net cash usage for 2014 may be approximately $12 million, reflecting increased investment in early-stage assets. At December 31, 2013, cash and investments were $49.8 million.  Financial Highlights for 2013    oTotal revenue increased to $41.1 million in 2013 from $10.6 million in     2012, reflecting a previously disclosed amendment in our strategic     alliance with Pfizer, Inc. In Q4 2013, we amended our strategic alliance     with Pfizer and, as a result, recognized all remaining non-cash deferred     revenue at the end of Q3 2013 as contract revenue during Q4 2013.        oWe do not expect to have taxable income in 2013 because the related     revenue was recognized for tax purposes in prior years.        oResearch and development expenses decreased to $4.9 million in 2013 from     $7.6 million in 2012, primarily due to lower cash compensation and     non-cash stock-related compensation.Research and development expenses     included non-cash stock-related compensation costs of $1.3 million in 2013     and $3.2 million in 2012.        oGeneral and administrative expenses decreased to $4.8 million in 2013 from     $7.2 million in 2012, primarily due to lower cash compensation and     non-cash stock-related compensation. General and administrative expenses     included non-cash stock-related compensation costs of $1.8 million in 2013     and $3.4 million in 2012.        oAt December 31, 2013, cash and investments were $49.8 million, compared to     $56.3 million at December 31, 2012.We have no debt.  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    *To date, we have received total cash payments of $185 million in program     fees and milestone payments under our strategic alliance with Pfizer.        *We are eligible to receive from Pfizer a $15.0 million payment upon FDA     approval of REMOXY.        *After the commercial launch of REMOXY by Pfizer, we will receive a royalty     of 20% of net sales in the United States, except as to the first $1.0     billion in cumulative net sales, which royalty is set at 15%. Outside the     United States, the royalty rate is 10%.        *We will also receive from Pfizer a supplemental payment of 6.0% to 11.5%     of net sales, depending on the range of total dollar sales in each year,     covered by the strategic alliance. This supplemental payment is tied to     the full amount of our financial obligations to Durect Corporation, our     exclusive supplier of certain excipients in REMOXY.        *In October 2013, Pfizer returned to us all rights with respect to     abuse-resistant formulations of three opioid drugs: hydrocodone,     hydromorphone and oxymorphone.These drug assets now vest exclusively in     us without any royalty or other obligation to Pfizer.We are free to     develop and commercialize these assets on our own or with a licensee of     our choice, and may do so without notice or approval from Pfizer.     Investigational New Drug (IND) applications for all three drug assets are     in place with FDA. We have not yet made a decision to develop or to     out-license these three drug assets.        *All development and commercialization expenses around REMOXY are     reimbursed or paid for by Pfizer.        *We retain commercial rights to REMOXY in Australia/New Zealand.We have     not yet announced a market entry strategy for these territories.  Conference Call  Pain Therapeutics will host a conference call today at 5:00 p.m. Eastern time to discuss 2013 financial results, provide guidance for 2014 and to respond to questions.  To participate in the conference call, please dial 1-877-407-9039 (within the U.S.) or 1-201-689-8470 (outside the U.S.) prior to the start of the call. Those interested in listening to the conference call live via the internet may do so by visiting the Company's website at www.paintrials.com. A playback of the call will be available for approximately 7 days after the live event. To access the playback, please dial 1-877-870-5176 (within the U.S.) or 1-858-384-5517 (outside the U.S.) and enter code 13575504.  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 use for 2014; the progress of REMOXY over the next few quarters, future growth of early stage assets, expectations related to taxable income for 2013; potential future milestone payments; reimbursement of development expenses for REMOXY and supplemental payments and royalties based on revenue from REMOXY.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 REMOXY; 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 (Unaudited, in thousands, except per share amounts)                                                                                          Three Months Ended      Years Ended                           December 31,            December 31,                           2013        2012^(1)    2013           2012^(1) Revenue:                                                      Program fee revenue      $ 35,244   $ 2,468   $ 41,119     $ 10,641 Collaboration revenue    —          —          —             249 Total revenue            35,244     2,468      41,119        10,890 Operating expenses:                                           Research and development 1,151      2,101      4,917         7,605 General and               1,190      2,209      4,837         7,182 administrative Total operating expenses 2,341      4,310      9,754         14,787 Operating income (loss)  32,903     (1,842)    31,365        (3,897) Interest and other        39         46         106           451 income, net Income (loss) before provision for (benefit     32,942     (1,796)    31,471        (3,446) from) income taxes Provision for (benefit    (73)       —          (73)          — from) income taxes Net income (loss)        $33,015   $(1,796)  $ 31,544     $ (3,446) Net income (loss) per                                          share Basic                    $ 0.73    $ (0.04)  $ 0.70       $ (0.08) Diluted                  $ 0.72    $ (0.04)  $ 0.70       $ (0.08) Weighted-average shares used in computing net                                           income (loss) per share Basic                    $ 45,059  $ 44,903  $ 45,007     $ 44,753 Diluted                  $ 45,862  $ 44,903  $ 45,208     $ 44,753                                                                CONDENSED BALANCE SHEETS                                                                                        December 31,                                                 2013           2012^(1)                                                 (Unaudited)   Assets                                                        Current assets                                                Cash, cash equivalents                          $ 49,838      $ 56,254 and marketable securities Other current assets                           265           253 Total current assets                           50,103        56,507 Other non-current assets                       —             352 Total assets                                   $ 50,103      $ 56,859 Liabilities and                                                stockholders' equity Current liabilities                                           Accounts payable and accrued development                              $ 1,086       $ 1,290 expenses Deferred program fee                            —             7,832 revenue - current portion Other accrued                                   715           877 liabilities Total current                                   1,801         9,999 liabilities Non-current liabilities                                       Deferred program fee revenue - non-current                            —             33,287 portion Other liabilities                              —             437 Total liabilities                              1,801         43,723 Stockholders' equity                                          Common stock                                   45            45 Additional                                      152,363       148,738 paid-in-capital Accumulated other                               1             4 comprehensive income Accumulated deficit                            (104,107)     (135,651) Total stockholders'                             48,302        13,136 equity Total liabilities and                           $ 50,103      $ 56,859 stockholders' equity                                                                (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                   Barbara Ryan          FTI Consulting          Barbara.ryan@fticonsulting.com          (212) 850-5679