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Pain Therapeutics Announces 2010 Financial Results and Outlines Business Goals for 2011

REMOXY NDA: PDUFA Date in June
LIKEABILITY STUDY RESULTS: APS Meeting in May
MELANOMA SURVIVAL DATA: ASCO Meeting in June

$91 Million in Cash, No Debt, Cash Requirements in 2011 under $5 Million

SAN MATEO, Calif., Feb. 3, 2011 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for the year ended December 31, 2010, provided an update on its cash position and outlined its business strategy for 2011.

Net loss for 2010 was $12.0 million, or $0.28 per share, (including a one-time, non-cash expense of $14.8 million related to our special cash distribution to shareholders), compared to net loss for 2009 of $3.5 million, or $0.08 per share. At December 31, 2010, we had $91 million of cash and no debt. We believe our cash requirements in 2011 will be under $5 million, before giving effect to the approval and commercial launch of REMOXY®, our lead drug candidate.

Key expectations for 2011 include the regulatory review of REMOXY and its commercial launch by King Pharmaceuticals, Inc. ("King"), a wholly owned subsidiary of Pfizer, Inc. (NYSE:PFE), and the release of new clinical data on certain of our drug candidates.

"I see 2011 as a landmark year for Pain Therapeutics," said Remi Barbier, Chairman, President & CEO. "We have established a reputation as a leader in drug development for breakthrough products and we think this is the year when some of our key innovations come to fruition."

About REMOXY

Our lead drug candidate, REMOXY (controlled-release oxycodone), is a strong painkiller with a unique abuse-resistant formulation designed to reduce potential risks of intentional abuse or accidental misuse. 

REMOXY Related Milestone Payments and Royalty

Science Strategy Our science strategy in 2011 is to spend carefully while keeping innovation at the top of our agenda. In general, we prefer to partner with academic groups to explore new scientific ideas, with reduced emphasis on internal discovery efforts that might create high fixed costs. Our R&D goals in 2011 will be to continue to focus on clinical stage drugs that can benefit from our core expertise in drug development, to outsource certain functions that permit the efficient deployment of our resources and to develop promising but un-partnered biotech assets. 

In 2010, we made disciplined investments in two important disease areas — hemophilia and melanoma. We own commercial rights to all of our drug candidates in hematology/oncology.

Our biotechnology pipeline includes:

2010 Financial Results

About Pain Therapeutics, Inc.

Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, a unique abuse-resistant controlled-release oxycodone, we have three drug candidates in clinical programs, including abuse-resistant formulations of hydromorphone, hydrocodone and oxymorphone, as well as a novel radio-labeled monoclonal antibody to treat metastatic melanoma. Pain Therapeutics is also 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 the timing of the FDA's review of the NDA for REMOXY; our anticipation that there will be no advisory committee meeting around REMOXY prior to the June PDUFA date; the timing associated with the completion of Pfizer's acquisition of King; expected cash requirements for 2011; potential milestone payments or other payments from King or Pfizer under the terms of our strategic alliance with King; the benefits of our lead drug candidate, REMOXY, including statements concerning its clinical efficacy; research and development and scientific goals; the presentation of clinical and other data at future scientific meetings; and our plans to relocate our corporate offices to Austin, Texas. 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 (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for our intellectual property or trade secrets, unanticipated additional research and development and other costs; potential delay or prevention of the completion of the acquisition of King by Pfizer; the timing and receipt of funds from our commercial partner, the potential for abuse resistant pain medications to be developed by competitors and potential competitors. For further information regarding these and other risks related to our business, investors should consult our filings with the Securities and Exchange Commission.

 
PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
       
  Three Months Ended December 31, Year Ended December 31,
  2010 2009 2010 2009(1)
Revenue         
Program fee revenue   $ 2,724  $ 3,587  $ 10,496  $ 14,348
Collaboration revenue   285  142  1,313  6,215
Milestone revenue   5,000  --   5,000  -- 
Total revenue   8,009  3,729  16,809  20,563
Operating expenses         
Research and development   8,010  3,811  15,746  21,059
General and administrative   9,510  1,584  14,766  6,258
Total operating expenses   17,520  5,395  30,512  27,317
Operating loss   (9,511)  (1,666)  (13,703)  (6,754)
Interest income   340  544  1,680  1,777
Loss before benefit from income taxes   (9,171)  (1,122)  (12,023)  (4,977)
Benefit from income taxes   --   (825)  --   (1,510)
Net loss   $ (9,171)  $ (297)  $ (12,023)  $ (3,467)
         
Net loss per share - basic and diluted   $ (0.21)  $ (0.01)  $ (0.28)  $ (0.08)
         
Weighted-average shares used in computing net income loss per share - basic and diluted   42,797  42,275  42,644  42,165
         
 
CONDENSED BALANCE SHEETS
      December 31,
      2010 2009(1)
      (Unaudited)  
Assets         
Current assets         
Cash, cash equivalents and marketable securities       $ 91,226  $ 175,759
Receivables       7,114  2,302
Other current assets       144  410
Total current assets       98,484  178,471
Non-current assets         
Property and equipment, net       285  517
Other assets       426  3,017
Total assets       $ 99,195  $ 182,005
         
Liabilities and stockholders' equity         
Current liabilities         
Accounts payable and accrued development expenses     $ 1,365  $ 2,538
Deferred program fee revenue - current portion       10,897  14,348
Other accrued liabilities       1,809  1,625
Total current liabilities       14,071  18,511
Non-current liabilities         
Deferred program fee revenue - non-current portion       51,760  53,805
Other liabilities       431  1,437
Total liabilities       66,262  73,753
Stockholders' equity         
Common stock       43  42
Additional paid-in-capital       161,957  225,432
Accumulated other comprehensive income       525  347
Accumulated deficit       (129,592)  (117,569)
Total stockholders' equity       32,933  108,252
Total liabilities and stockholders' equity       $ 99,195  $ 182,005
         
(1) Derived from the Company's annual financial statements as of December 31, 2009, 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

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