-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MjnpqsxpIHwxiDeqRbfdWk/v+UTDyg89gM0tB/swgRsP4QkB5KM9I87usedgIzk7 lzswuQ/FIURByVc/OpF4Iw== 0001171843-10-002188.txt : 20101028 0001171843-10-002188.hdr.sgml : 20101028 20101028083027 ACCESSION NUMBER: 0001171843-10-002188 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20101028 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101028 DATE AS OF CHANGE: 20101028 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PAIN THERAPEUTICS INC CENTRAL INDEX KEY: 0001069530 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 911911336 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29959 FILM NUMBER: 101146419 BUSINESS ADDRESS: STREET 1: 2211 BRIDGEPOINTE PARKWAY STREET 2: SUITE 500 CITY: SAN MATEO STATE: CA ZIP: 94404 BUSINESS PHONE: 6506248200 MAIL ADDRESS: STREET 1: 2211 BRIDGEPOINTE PARKWAY STREET 2: SUITE 500 CITY: SAN MATEO STATE: CA ZIP: 94404 8-K 1 document.htm FORM 8-K FILING DOCUMENT 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)

October 28, 2010


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.)



2211 Bridgepointe Parkway, Suite 500, San Mateo, CA 94404
(Address of principal executive offices, including zip code)

(650) 624-8200
(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 28, 2010 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 28, 2010


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 28, 2010   /s/   PETER S. RODDY
Peter S. Roddy
Vice President & Chief Financial Officer
EX-99.1 2 newsrelease.htm PRESS RELEASE Pain Therapeutics Reports Third Quarter 2010 Financial Results

EXHIBIT 99.1

Pain Therapeutics Reports Third Quarter 2010 Financial Results

- REMOXY® NDA Resubmission Still Anticipated Q4 2010 -

- Cash Distribution of $2.00 Per Share Payable to Shareholders in December 2010 -

SAN MATEO, Calif., Oct. 28, 2010 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for its third quarter of fiscal year 2010.

Financial Highlights

  • Our net loss for the quarter ending September 30, 2010 was $1.0 million, or $0.02 per share, compared to net loss of $1.3 million or $0.03 per share, for the third quarter of 2009.
  • In July 2010, King Pharmaceuticals, Inc. (NYSE:KG) paid us a $5.0 million program fee related to previously disclosed modifications of our strategic alliance.
  • We maintained our strong financial position, with cash and total investments of $180 million, or about $4.21 cash per share, and no debt, before giving effect to a previously announced and pending nondividend distribution.
  • No change to previous guidance - cash requirements in 2010 still expected to be under $5 million, before giving effect to a previously announced and pending nondividend distribution.

"We reported today another solid quarter as we prepare for our next phase of growth", said Remi Barbier, Chairman, President & CEO of Pain Therapeutics. "We continue to believe REMOXY represents the rare combination of a well-partnered, late-stage drug asset with a unique profile, and whose clinical efficacy has been substantially de-risked."

Additional Highlights

  • On October 27, 2010, we declared a cash distribution of $2.00 per share to shareholders, or an aggregate of about $85 million. This nondividend distribution will be paid to shareholders of record as of the close of business on December 1, 2010. We expect to pay shareholders on or around December 10, 2010. The nondividend distribution will be paid entirely from cash reserves.
  • King is our commercial partner for REMOXY, our lead drug candidate. To date, we have received from King total cash payments of $180.0 million in various program fees and milestone payments in connection with our strategic alliance. We could receive from King up to $125.0 million in additional milestone payments over the course of the clinical and regulatory development of REMOXY and three other abuse-resistant pain medications.
  • On October 12, 2010, Pfizer Inc. (NYSE:PFE) and King announced that they had entered into a definitive merger agreement. Pfizer is the world's largest research-based pharmaceutical company. We believe Pfizer's acquisition of King, if consummated, may facilitate REMOXY's commercial success if this drug is approved.
  • King plans to resubmit an NDA for REMOXY in Q4 2010. Upon FDA approval of REMOXY, we will receive a $15.0 million cash milestone payment and a running royalty equal to 20% of net sales in the U.S. of all drugs developed under this strategic alliance, 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 set at 10%.
  • We intend to relocate our principal place of business to Austin, TX. In order to minimize potential disruptions to our on-going operations, this relocation will take place gradually now through the end of 2011. Our intentions are to shift the Company's permanent headquarters and the entire actual direction, control, and coordination of our operations, from California to Austin, TX.
  • Recently, our executive officers have elected to cease personal stock trading plans that were in effect under Rule 10b5-1 of the Securities Exchange Act of 1934 and our policies regarding stock transactions. 

Third Quarter Financial Results

  • In Q3 2010, King paid us a $5.0 million program fee in connection with the June 2010 modification of our strategic alliance.
  • Collaboration revenue for Q3 2010 was $0.2 million and reflects reimbursement of our development expenses under our strategic alliance with King.
  • Research and development expenses for Q3 2010 decreased to $2.4 million from $4.5 million for Q3 2009. This decrease was mostly due to decreased activities for our product candidates and lower operating costs. Research and development expenses included non-cash stock-related compensation costs of $0.6 million for Q3 2010 and $0.9 million for Q3 2009. 
  • General and administrative expenses for Q3 2010 increased to $2.1 million from $1.5 million for Q3 2009. This increase was mostly due to fluctuations in and timing of operating costs. General and administrative expenses included non-cash stock-related compensation costs of $0.5 million for Q3 2010 and $0.7 million for Q3 2009. 

About REMOXY

Our lead drug candidate, REMOXY, is a strong painkiller with a unique abuse-resistant formulation designed to reduce potential risks of intentional abuse or accidental misuse. REMOXY and three other abuse-resistant pain medications are being developed pursuant to our strategic alliance with King. King has sole responsibility for the commercialization of REMOXY worldwide, except for Australia and New Zealand. 

Hematology/Oncology

Our corporate strategy is to spend carefully but to keep innovation at the top of our agenda. In Q3 2010, we continued to make disciplined investments in two important disease areas - melanoma and hemophilia. We own commercial rights to all of our drug candidates in hematology/oncology.

  • A radio-labeled monoclonal antibody program, developed at Albert Einstein College of Medicine, is aimed at treating patients with late-stage (metastatic) melanoma. This drug candidate is called PTI-188. We've previously reported positive Phase I clinical data with PTI-188 in metastatic melanoma. Although efficacy was not a primary endpoint, PTI and its clinical investigators were encouraged by the number of melanoma tumors that had either stabilized or decreased in size after a single dose of PTI-188. Preliminary analysis, combining two Phase I studies, indicated a median overall survival time of 13 months (n=19).
  • We have a gene transfer program, developed at Stanford University, aimed at correcting an underlying genetic defect in patients with hemophilia. Importantly, no viral vector is utilized. Preclinical studies remain on-going.

About Pain Therapeutics, Inc.

Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, we have three other drug candidates in clinical programs. This includes a novel monoclonal antibody-based treatment against metastatic melanoma. We are also developing a new treatment for patients with hemophilia, a genetic disorder in which patients are unable to stop bleeding. For more information about us, 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.

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 King's resubmission of the NDA for REMOXY in Q4 2010; the benefits to the commercialization of REMOXY, if approved, that may result from the completion of the Pfizer's announced acquisition of King; our expected receipt of milestone payments or other revenue under our collaboration with King; our expected net cash burn rate for 2010; the tax treatment of the special nondividend distribution; and the benefits of REMOXY. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements in volve 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 the Company's drug candidates; unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates; the uncertainty of delay or abandonment of the announced acquisition of King by Pfizer; the uncertainty of patent protection for the Company's intellectual property or trade secrets; unanticipated additional research and development and other costs; the timing and receipt of funds from King; the potential for abuse resistant pain medications to be developed by competitors and potential competitors to the Company; and the potential for Pfizer, if the acquisition of King is completed, to hold rights to products or product candidates that may be competitive to REMOXY. 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 September 30, Nine Months Ended September 30,
  2010 2009 2010 2009
 Revenue        
 Program fee revenue  $  2,724  $ 3,587  $ 7,772  $ 10,761
 Collaboration revenue  171  176  1,028  6,073
 Total revenue  2,895  3,763  8,800  16,834
 Operating expenses        
 Research and development   2,360  4,521  7,736  17,247
 General and administrative   2,107   1,530  5,256  4,675
 Total operating expenses  4,467  6,051  12,992  21,922
 Operating loss  (1,572)  (2,288)   (4,192)  (5,088)
 Interest income  544  613  1,340  1,233
 Loss before benefit from income taxes   (1,028)  (1,675)  (2,852)   (3,855)
 Benefit from income taxes  --   (363)  --   (685)
 Net loss  $ (1,028)  $ (1,312)  $ (2,852)  $ (3,170)
         
 Net loss per share - basic and diluted  $ (0.02)  $ (0.03)  $ (0.07)  $ (0.08)
 Weighted-average shares used in computing        
 net loss per share - basic and diluted  42,703   42,201  42,593  42,143
 
CONDENSED BALANCE SHEETS
 
      September 30, December 31,
      2010 2009(1)
 Assets     (Unaudited)  
 Current assets        
 Cash, cash equivalents and marketable securities      $ 179,742  $ 175,759
 Other current assets      286  $ 2,712
 Total current assets      180,028 178,471
 Non-current assets        
 Property and equipment, net       340  517
 Other assets      426  3,017
 Total assets      $ 180,794  $ 182,005
         
 Liabilities and stockholders' equity        
 Current liabilities        
 Accounts payable and accrued development expenses      $ 1,361  $ 2,538
 Deferred program fee revenue - current portion      10,897  14,348
 Other accrued liabilities      2,431   1,625
 Total current liabilities      14,689  18,511
 Non-current liabilities        
 Deferred program fee revenue - non-current portion      54,484  53,805
 Other liabilities      430  1,437
 Total liabilities      69,603  73,753
 Stockholders' equity        
 Common stock      43  42
 Additional paid-in-capital      230,876  225,432
 Accumulated other comprehensive income       693  347
 Accumulated deficit      (120,421)  (117,569)
 Total stockholders' equity        111,191  108,252
 Total liabilities and stockholders' equity      $ 180,794  $ 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:  Pain Therapeutics, Inc.
          Judy Ishida, Administrative Manager
          650-645-1924
          IR@paintrials.com
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