Form 8-K Filing

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)

August 2, 2012


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.)



7801 N Capital of Texas Highway, Suite 260, Austin, TX 78731
(Address of principal executive offices, including zip code)

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 August 2, 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 August 2, 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.


Dated: August 2, 2012   /s/   PETER S. RODDY
Peter S. Roddy
Vice President & Chief Financial Officer
Pain Therapeutics Reports Q2 2012 Financial Results

EXHIBIT 99.1

Pain Therapeutics Reports Q2 2012 Financial Results

No Change to Financial Guidance for 2012

AUSTIN, Texas, Aug. 2, 2012 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the quarter and six months ended June 30, 2012. Net loss for Q2 2012 was $0.1 million, or $0.00 per share, as compared to the net loss in Q2 2011 of $1.2 million, or $0.03 per share. Net loss for the first half of 2012 was $0.1 million, or $0.00 per share, as compared to net loss for the first half of 2011 of $1.4 million, or $0.03 per share.

Cash and investments were $93.9 million at June 30, 2012. Actual net cash usage for the first half of 2012 was $4.2 million, versus guidance of $5.0 million.  The Company has no debt.

Management continues to believe net cash usage for 2012 will be under $10.0 million.

"Financial results reflect our goal to maintain tight financial discipline while waiting for the regulatory resubmission of REMOXY by our partner, Pfizer," said Remi Barbier, Chairman, President & CEO of Pain Therapeutics. "We remain excited by the prospect of having a potential first-in-class oxycodone drug in a $3+ billion market."

Q2 2012 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 analgesic misuse and abuse.

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. 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. 

In December 2011, we were served notice of two civil lawsuits filed in the District Court of the Western District of Texas, Austin Division.  Both relate to the attempt to obtain FDA approval for REMOXY.  One complaint is a shareholder derivative suit and alleges breach of fiduciary duty.  The District Court dismissed this complaint in April 2012. The other complaint alleges various violations of the Securities Exchange Act.  We believe the remaining lawsuit is without merit and intend to vigorously contest it.

About Pain Therapeutics, Inc.

Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In July 2012, we announced the publication of preclinical data that demonstrate a promising new approach to treat Alzheimer's disease. 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 net cash usage for 2012, Pfizer's plans with respect to development of REMOXY, potential future milestone payments and royalties based on revenue from REMOXY, the potential development of other abuse resistant drug candidates, funding obligations of Pfizer, the benefits of REMOXY, currently ongoing litigation and the Company's new approach to treat Alzheimer's disease. 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, 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, the potential for abuse resistant pain medications or other competing products or therapies to be developed by competitors and potential competitors or others and difficulties resulting from, or risks associated with, pending litigation, including diversion of resources and potential adverse judgments. 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.

PAIN THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
       
  Three months ended Six months ended
  June 30, 2012 June 30, 2012
Revenue         
Program fee revenue   $ 2,724  $ 2,724  $ 5,448  $ 5,448
Collaboration revenue   --   28  249  540
Total revenue   2,724  2,752  5,697  5,988
Operating expenses         
Research and development   1,516  2,392  3,125  4,571
General and administrative   1,461  1,788  2,973  3,324
Total operating expenses   2,977  4,180  6,098  7,895
Operating loss   (253)  (1,428)  (401)  (1,907)
Interest income   123  228  300  500
Net loss  $ (130)  $ (1,200)  $ (101)  $ (1,407)
         
Net loss per share, basic and diluted  $ (0.00)  $ (0.03)  $ (0.00)  $ (0.03)
Weighted-average shares used in computing net loss per share, basic and diluted  44,777  44,190  44,754  43,660
         
CONDENSED BALANCE SHEETS
(in thousands)
      June 30,
2012
December 31,
2011(1)
      (Unaudited)  
Assets         
Current assets         
Cash, cash equivalents and marketable securities     $ 93,942  $ 98,131
Other current assets       95  358
Total current assets       94,037  98,489
Non-current assets         
Property and equipment, net and other assets       403  474
Total assets       $ 94,440  $ 98,963
Liabilities and stockholders' equity         
Current liabilities         
Accounts payable and accrued development expenses     $ 1,106  $ 1,378
Deferred program fee revenue - current portion     10,897  10,897
Other accrued liabilities       418  997
Total current liabilities       12,421  13,272
Non-current liabilities         
Deferred program fee revenue - non-current portion     35,415  40,863
Other liabilities       435  435
Total liabilities       48,271  54,570
Stockholders' equity         
Common stock and additional paid-in-capital       178,432  176,470
Accumulated other comprehensive income       43  128
Accumulated deficit       (132,306)  (132,205)
Total stockholders' equity       46,169  44,393
Total liabilities and stockholders' equity       $ 94,440  $ 98,963
         
(1) Derived from the Company's annual financial statements as of December 31, 2011, 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