Pain Therapeutics Announces Year-End 2008 Financial Results, Outlines 2009 Business Priorities

Thursday, February 05, 2009 8:31 AM


             Net income of $0.35 Per Share for 2008
              $190 Million of Cash on Hand, No Debt
     Cash Requirements in 2009 Expected to be Under $10 Million

SAN MATEO, Calif., Feb. 5, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for the year ended December 31, 2008. The Company also provided an update on its cash position and outlined its business strategy for maintaining financial strength in 2009.

Net income for the year ended December 31, 2008 was $15.3 million, or $0.35 per diluted share, compared to net income of $20.3 million, or $0.44 per diluted share, for 2007. Net loss for the quarter ended December 31, 2008 was $1.4 million, or $0.03 per diluted share, compared to net income of $1.1 million, or $0.02 per diluted share for the fourth quarter of 2007.

At December 31, 2008, Pain Therapeutics had cash, cash equivalents and marketable securities of $190.1 million, no debt and approximately 42 million shares outstanding. The Company expects its cash requirements in 2009 will be under $10.0 million.

"We're bracing for a vital 2009," said Remi Barbier, Pain Therapeutics' chairman, president and chief executive officer. "We believe core strength in 2009 will be based on regulatory momentum with REMOXY(r) and clinical progress with the biotech side of Pain Therapeutics. We also recognize that financial wreckage has sent shock waves through every industry, ours included. In this environment, it's imperative to protect the strength of our balance sheet while supporting key science objectives in 2009."

2009 Financial and Operating Guidance


  *  Pain Therapeutics started 2009 with $190.1 million of cash
     and investments and no debt.
  *  We expect cash requirements in 2009 will be under $10.0
     million, which includes a significant investment in the
     growth of our biotech pipeline.  We retain commercial rights
     to our entire biotech pipeline.
  *  Pursuant to the terms of a strategic alliance, our commercial
     partner, King Pharmaceuticals, Inc., is obligated to fund
     development expenses incurred by us for REMOXY and three
     other abuse-resistant pain medications.  Upon approval,
     Pain Therapeutics will receive a running royalty equal to
     20% of net sales of drugs developed under this strategic
     alliance, except as to the first $1.0 billion in cumulative
     net sales, which royalty is set at 15%.
  *  The U.S. Food and Drug Administration (FDA) believes
     additional non-clinical data will be required to support the
     approval of REMOXY.  The FDA has not requested or recommended
     additional clinical efficacy studies prior to approval. We
     plan to meet with the FDA in Q2 2009.  We believe this FDA
     meeting will provide us with a more reliable context in which
     to make projections about REMOXY.
  *  A monoclonal antibody program, developed at Albert Einstein
     College of Medicine, is aimed at treating patients with
     late-stage melanoma.  We expect to complete a second Phase
     I study with this technology in 2009.  We are also exploring
     the use of similar technology to treat other important
     disease areas.  This drug asset is unpartnered.
  *  A gene transfer program, developed at Stanford University,
     is aimed at correcting an underlying genetic defect in
     patients with hemophilia.  We expect to complete a significant
     animal study with this technology in 2009.  We are also
     planning a first-in-human clinical study with this
     technology in 2009.  This drug asset is unpartnered.
  *  In general, our R&D goals in 2009 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 unpartnered biotech assets.

2008 Financial Highlights


  *  Milestone revenue of $20.0 million for 2008 included a
     $15.0 million milestone payment from King related to the
     acceptance by the FDA of the New Drug Application for REMOXY
     and a $5.0 million milestone payment from King related to
     the acceptance by the FDA of an investigational new drug
     application for PTI-721.
  *  Collaboration revenue for 2008 was $29.4 million, compared
     to $42.7 million for 2007 and reflects reimbursement of our
     development expenses under our strategic alliance with King.
  *  Research and development expenses for 2008 decreased to
     $45.8 million from $47.7 million for 2007.  Research and
     development expenses for the fourth quarter of 2008 decreased
     to $9.2 million from $13.6 million for the fourth quarter of
     2007.  These decreases were mostly due to decreased spending
     for REMOXY and the other abuse-resistant product candidates
     under our strategic alliance with King.

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