SAN MATEO, Calif., May 7, 2008 (PrimeNewswire via COMTEX News Network) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for the three months ended March 31, 2008. Net income for the quarter ended March 31, 2008 was $2.6 million, or $0.06 per share, compared to net income of $12.6 million, or $0.28 per share, in the first quarter of 2007.
Cash, cash equivalents and marketable securities were $190.1 million at March 31, 2008.
"I'm confident our business model is poised to show long-term growth" said Remi Barbier, Pain Therapeutics' president and chief executive officer. "The fundamentals of our business are on-track. We have significant cash on hand and are debt-free. We continue to buy back our stock in the open market and drive innovation in our early-stage pipeline."
Based on productive meetings with the U.S. Food and Drug Administration (FDA), Pain Therapeutics is on-track to submit a New Drug Application (NDA) for Remoxy(tm) in the second quarter of 2008. Remoxy is an abuse-resistant, long-acting formulation of oxycodone. The Company believes its NDA for Remoxy benefits from years of rigorous and independent scientific and clinical testing. In addition, the Company believes its Special Protocol Assessment for Remoxy remains in full-force without modification.
Q1 2008 Financial Highlights
* On March 31, 2008, we announced that we increased the size of our stock buyback plan to $30.0 million, through March 2009. As of March 31, 2008, we had purchased $20.6 million of our stock in the open market. * Collaboration revenue of $11.1 million in the first quarter of 2008 reflects reimbursement of our development expenses under our strategic alliance with King Pharmaceuticals, Inc. (King). * Research and development expenses for the first quarter of 2008 increased to $12.5 million from $9.9 million for the first quarter of 2007. The increase in research and development expenses was primarily due to planned increases in development activities for our abuse-resistant product candidates. Research and development expenses included $0.9 million and $0.7 million of non-cash stock related compensation costs in the first quarters of 2008 and 2007, respectively. * General and administrative expenses were $1.8 million in each of the first quarters of 2008 and 2007. General and administrative expenses included $0.5 million of non-cash stock related compensation costs in each of the first quarters of 2008 and 2007.
2008 Financial Guidance - No Changes
* We anticipate being cash flow positive in 2008, before using cash for our stock buyback plan. * We anticipate receiving $20.0 million of cash milestone payments in 2008 under our strategic alliance with King as follows: o We expect to file an NDA for Remoxy in Q2 2008; acceptance of this NDA by the FDA triggers a $15.0 million cash milestone payment from King. o We expect to file an Investigational New Drug application (IND) for a new abuse-resistant opioid in 2008; acceptance of this IND by the FDA triggers a $5.0 million cash milestone payment from King. * We anticipate spending up to $15.0 million developing biopharmaceutical products for metastatic melanoma, hemophilia and other important disease areas. We hold all commercial rights to these biopharmaceutical drug candidates.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In December 2007, we announced that Remoxy met the primary endpoint (p less than 0.01) of a pivotal Phase III study in over 400 patients with osteoarthritis; as a result, we plan to file an NDA for Remoxy in Q2 2008. We also have other drug candidates in clinical programs, including a novel radio-labeled monoclonal antibody to treat metastatic melanoma, as well as PTI-202 and Oxytrex(tm). In addition, we are working on a new treatment for patients with hemophilia. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. 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, Inc. 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, scope or expected outcome of the Company's clinical development of its drug candidates, including filing an NDA for Remoxy in the second quarter of 2008 and filing an IND for a new abuse-resistant opioid, the Company's confidence in its business model to show long-term growth, the Company's belief that its Special Protocol Assessment for Remoxy remains without modification, the Company's belief that the NDA for Remoxy benefits from years of rigorous and independent scientific and clinical testing, the Company's early-stage pipeline, the Company's expected spending in 2008, including with respect to its business model development efforts, the potential milestone and other payments from King, including with respect to the expected NDA filing for Remoxy and the potential benefits of the Company's drug candidates. 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, regulatory approval, production and marketing of the Company's drug candidates and potential drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates and potential drug candidates that could slow or prevent regulatory filings, product approval or market acceptance (including the risk that current and past results of clinical trials and testing are not necessarily indicative of future results of clinical trials and testing), the uncertainty of patent protection for the Company's intellectual property or trade secrets, the Company's ability to obtain additional financing if necessary, unanticipated research and development and other costs, and the timing or receipt of payments from King. 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 March 31, -------------------- 2008 2007 -------- -------- Revenue Collaboration revenue $ 11,052 $ 15,504 Program fee revenue 3,587 6,550 -------- -------- Total revenue 14,639 22,054 Operating expenses Research and development 12,484 9,860 General and administrative 1,819 1,838 -------- -------- Total operating expenses 14,303 11,698 -------- -------- Operating income 336 10,356 Interest income 2,234 2,280 -------- -------- Net income $ 2,570 $ 12,636 ======== ======== Net income per share Basic $ 0.06 $ 0.28 ======== ======== Diluted $ 0.06 $ 0.28 ======== ======== Weighted-average shares used in computing net income per share Basic 43,848 44,341 ======== ======== Diluted 45,388 45,591 ======== ======== PAIN THERAPEUTICS, INC. CONDENSED BALANCE SHEETS March 31, Dec. 31, 2008 2007(1) -------- -------- (Unaudited) Assets Current assets Cash, cash equivalents and marketable securities $190,052 $205,071 Other current assets 311 303 -------- -------- Total current assets 190,363 205,374 Non-current assets Property and equipment, net 1,490 1,607 Other assets 644 644 -------- -------- Total assets $192,497 $207,625 ======== ======== Liabilities and stockholders' equity Current liabilities Accounts payable $ 2,962 $ 3,624 Accrued development expense 973 817 Deferred program fee revenue - current portion 14,348 14,348 Other accrued liabilities 2,423 1,868 -------- -------- Total current liabilities 20,706 20,657 Non-current liabilities Deferred program fee revenue - non-current portion 78,915 82,501 Other liabilities 553 553 -------- -------- Total liabilities 100,174 103,711 -------- -------- Stockholders' equity Common stock 42 44 Additional paid-in-capital 214,238 221,415 Accumulated other comprehensive income 905 584 Accumulated deficit (122,862) (118,129) -------- -------- Total stockholders' equity 92,323 103,914 -------- -------- Total liabilities and stockholders' equity $192,497 $207,625 ======== ======== (1) Derived from audited financial statements.
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SOURCE: Pain Therapeutics, Inc.
Pain Therapeutics, Inc. Christi Waarich, Senior Manager of Investor Relations 650-645-1924 email@example.com
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