EX-99.1 3 e17581ex99_1.txt PRESS RELEASE Exhibit 99.1 Pain Therapeutics Announces First Quarter 2004 Financial Results SOUTH SAN FRANCISCO, Calif., April 22 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE), a biopharmaceutical company, today reported financial results for the three months ended March 31, 2004. The net loss for the quarter ended March 31, 2004 was $10.2 million, or $0.29 per share, compared to a net loss of $4.6 million, or $0.17 per share in the first quarter of 2003. Cash, cash equivalents and marketable securities were $70.2 million at March 31, 2004. The Company continues to expect its cash requirements for 2004 to be approximately $37 million, plus or minus ten percent. "We are pleased with our clinical and financial results for the first quarter of 2004," said Remi Barbier, president and chief executive officer. "We met 100 percent of our written milestones on-time, on-budget." Research and development expenses for the first quarter of 2004 increased to $9.5 million from $3.8 million in the first quarter of 2003 primarily due to clinical trial related expenses for Oxytrex(TM), PTI-901 and Remoxy(TM), including the costs associated with the recent initiation of a second Phase III study with Oxytrex. General and administrative expenses decreased to $0.9 million in the first quarter of 2004 from $1.0 million in the first quarter of 2003 primarily due to lower non-cash equity related expenses. No Changes to Financial Outlook Cash, cash equivalents and marketable securities were $70.2 million at March 31, 2004. We continue to expect our cash requirements for 2004 to be approximately $37 million, plus or minus ten percent. We continue to expect our net loss for 2004 to be approximately $39 million, plus or minus 10 percent. The net loss for 2004 is expected to be higher than the cash requirements primarily due to non-cash expenses included in the net loss. Our cash spending and expenses will continue to fluctuate on a quarter-to-quarter basis depending on the timing of our clinical studies and related expenses. Expected Announcements Q2 2004 -- Remoxy Study Results: Phase I/pharmacokinetics and Anti-abuse Data in Humans -- Technical Presentation at American Pain Society Meeting (May 6-9, Vancouver, Canada) -- Clinical Progress Conference Call (Oxytrex, Remoxy, PTI-901) About Pain Therapeutics, Inc. We are a biopharmaceutical company that develops novel drugs. Our drugs target severe chronic pain, such as pain associated with osteoarthritis, low-back pain or irritable bowel syndrome. We have three unique drug candidates in clinical development: Oxytrex, Remoxy and PTI-901. Our two most advanced drugs, Oxytrex and PTI-901, are in Phase III clinical trials. Remoxy is in Phase I clinical trials in the United Kingdom. We believe the target market for our three drug candidates exceeds $3 billion per year. We currently retain commercial rights to our drug candidates. For more information, please visit our website at 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"). PTI 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, the Company's expected cash requirements in 2004 and through late-stage development of its drug candidates, the Company's net loss for 2004, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. 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, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (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 the Company's intellectual property or trade secrets, the Company's ability to obtain additional financing if necessary and unanticipated research and development and other costs. 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, including its Form 10-K for the year ended December 31, 2003 and its subsequent periodic filings. PAIN THERAPEUTICS, INC. (A Development Stage Enterprise) CONDENSED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended March 31, 2004 2003 Operating expenses (1): Research and development $9,496 $3,788 General and administrative 937 970 Total operating expenses 10,433 4,758 Operating loss (10,433) (4,758) Other income: Interest income 270 141 Net loss $(10,163) $(4,617) Basic and diluted loss per share $(0.29) $(0.17) Weighted-average shares used in computing basic and diluted loss per share 35,426 27,157 (1) Included in research and development and general and administrative expenses are stock-based compensation expenses of $52 and $103 for the quarters ended March 31, 2004 and 2003, respectively. PAIN THERAPEUTICS, INC. (A Development Stage Enterprise) BALANCE SHEETS (Unaudited) (in thousands) March 31, December 31, 2004 2003(2) Assets Current assets: Cash, cash equivalents and marketable securities $70,185 $77,429 Prepaid expenses 355 1,321 Total current assets 70,540 78,750 Property and equipment, net 1,810 1,688 Other assets 75 75 Total assets $72,425 $80,513 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $5,105 $3,441 Accrued compensation and benefits 580 369 Other accrued liabilities 135 141 Total liabilities 5,820 3,951 Stockholders' equity Common stock 35 35 Additional paid-in-capital 150,824 150,725 Accumulated other comprehensive income 157 50 Deficit accumulated during the development stage (84,411) (74,248) Total stockholders' equity 66,605 76,562 Total liabilities and stockholders' equity $72,425 $80,513 (2) Derived from audited financial statements. SOURCE Pain Therapeutics, Inc. -0- 04/22/2004 /CONTACT: Christi Waarich, Senior Manager of Investor Relations of Pain Therapeutics, Inc., +1-650-825-3324; or media, Kathy Jones, Ph.D. of Burns McClellan, +1-212-213-0006, or cwaarich@paintrials.com, for Pain Therapeutics, Inc./ /Web site: http://www.paintrials.com / (PTIE) CO: Pain Therapeutics, Inc. ST: California IN: BIO MTC HEA SU: ERN ERP CCA