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Pain Therapeutics Announces First Quarter 2009 Financial Results
Thursday, April 30, 2009 8:02 AM


SAN MATEO, Calif., April 30, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reported financial results for the quarter ended March 31, 2009. Net loss for the quarter ended March 31, 2009 was $1.8 million, or $0.04 per diluted share, compared to net income of $2.6 million, or $0.06 per diluted share, for the first quarter of 2008.

"We recognize the importance of managing our balance sheet very carefully in this difficult macroeconomic environment," said Remi Barbier, president & chief executive officer of Pain Therapeutics. "Our strategy is to spend carefully but to keep innovation at the top of our agenda. Our immediate goals are to maintain regulatory momentum for Remoxy and to significantly advance our hematology/oncology programs."

At March 31, 2009, Pain Therapeutics had $185.6 million in cash, no debt and approximately 42.1 million shares outstanding, or $4.41 of cash per share. Net cash requirements in 2009 are still expected to be approximately $10 million, which includes a significant investment in the growth of its biotech pipeline.

Q1 2009 Financial and Operating Update


 * We reiterate existing regulatory guidance for REMOXY.  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.
 * As previously disclosed, regulatory responsibility for FDA approval
   of REMOXY was recently shifted to King Pharmaceuticals, Inc.  King
   plans to meet with the FDA in mid-2009.  This FDA meeting should
   provide a more reliable context in which to make projections about
   REMOXY.
 * There are no changes to the economic terms of our strategic
   alliance with King.  Pursuant to the terms of a strategic alliance,
   King will continue to fund development expenses incurred by us for
   REMOXY and three other abuse-resistant pain medications.  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 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%.
 * We retain all commercial rights to our biotech pipeline, which
   includes a clinical-stage treatment for melanoma and a pre-clinical
   program to cure hemophilia.
 * In melanoma, we are developing a radio-labeled monoclonal antibody
   program for 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.
 * In hemophilia, we are developing a biological agent aimed at
   correcting an underlying genetic defect in patients with hemophilia.
   We expect to complete a significant pre-clinical study with this
   technology in 2009.
 * In order to focus on the growth of our biotech pipeline, in Q1 2009
   we discontinued the development of Oxytrex(tm) and reverted rights
   to this drug to Albert Einstein College of Medicine.
 * Collaboration revenue for Q1 2009 was $3.2 million, compared to
   $11.1 million for Q1 2008 and reflects reimbursement of our
   development expenses under our strategic alliance with King.
 * Research and development expenses for Q1 2009 decreased to $7.6
   million from $12.5 million for Q1 2008.  This decrease was mostly
   due to decreased spending for REMOXY and the other abuse-resistant
   product candidates under our strategic alliance with King.
   Research and development expenses included non-cash stock-related
   compensation costs of $1.1 million for Q1 2009 and $1.0 million for
   Q1 2008.
 * General and administrative expenses for Q1 2009 decreased to $1.7
   million from $1.8 million for Q1 2008.  This decrease was mostly
   due to lower operating costs.


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