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Pain Therapeutics Reports 2013 Financial Results And Provides Guidance For 2014

AUSTIN, Texas, Feb. 4, 2014 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for 2013 and provided guidance for 2014. Net profit in 2013 was $31.5 million, or $0.70 per diluted share, compared to a net loss in 2012 of $3.4 million, or $0.08 per share.

"We are excited about what lies ahead for PTIE in 2014," said Remi Barbier, President & CEO. "We'll be watching the progress of REMOXY carefully over the next few quarters, as Pfizer has stated an intent to refile an NDA mid-2015. Any moves towards risk-reduction around this drug candidate may accelerate our corporate strategy to transition from purely an R&D company to a mix of R&D and product revenue. Based on the clinical and commercial profiles of REMOXY, and potential upside of our early-stage assets, I believe 2014 may be a pivotal year for us."

We expect net cash usage for 2014 may be approximately $12 million, reflecting increased investment in early-stage assets. At December 31, 2013, cash and investments were $49.8 million.

Financial Highlights for 2013

  • Total revenue increased to $41.1 million in 2013 from $10.6 million in 2012, reflecting a previously disclosed amendment in our strategic alliance with Pfizer, Inc. In Q4 2013, we amended our strategic alliance with Pfizer and, as a result, recognized all remaining non-cash deferred revenue at the end of Q3 2013 as contract revenue during Q4 2013.  
  • We do not expect to have taxable income in 2013 because the related revenue was recognized for tax purposes in prior years.  
  • Research and development expenses decreased to $4.9 million in 2013 from $7.6 million in 2012, primarily due to lower cash compensation and non-cash stock-related compensation. Research and development expenses included non-cash stock-related compensation costs of $1.3 million in 2013 and $3.2 million in 2012.  
  • General and administrative expenses decreased to $4.8 million in 2013 from $7.2 million in 2012, primarily due to lower cash compensation and non-cash stock-related compensation. General and administrative expenses included non-cash stock-related compensation costs of $1.8 million in 2013 and $3.4 million in 2012.  
  • At December 31, 2013, cash and investments were $49.8 million, compared to $56.3 million at December 31, 2012. We have no debt.

ABOUT REMOXY

Our lead drug candidate, REMOXY ®, is an extended-release oral formulation of oxycodone for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. We designed REMOXY to discourage common methods of tampering and misuse. Pfizer, Inc. (NYSE:PFE) is our exclusive, worldwide commercial partner for REMOXY (oxycodone) Extended-Release Capsules CII, except as to Australia and New Zealand.

REMOXY Deal Economics

  • To date, we have received total cash payments of $185 million in program fees and milestone payments under our strategic alliance with Pfizer.  
  • We are eligible to receive from Pfizer a $15.0 million payment upon FDA approval of REMOXY.  
  • After the commercial launch of REMOXY by Pfizer, we will receive a royalty of 20% of net sales in the United States, 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 10%.  
  • We will also receive from Pfizer a supplemental payment of 6.0% to 11.5% of net sales, depending on the range of total dollar sales in each year, covered by the strategic alliance. This supplemental payment is tied to the full amount of our financial obligations to Durect Corporation, our exclusive supplier of certain excipients in REMOXY.  
  • In October 2013, Pfizer returned to us all rights with respect to abuse-resistant formulations of three opioid drugs: hydrocodone, hydromorphone and oxymorphone. These drug assets now vest exclusively in us without any royalty or other obligation to Pfizer. We are free to develop and commercialize these assets on our own or with a licensee of our choice, and may do so without notice or approval from Pfizer.  Investigational New Drug (IND) applications for all three drug assets are in place with FDA.  We have not yet made a decision to develop or to out-license these three drug assets.  
  • All development and commercialization expenses around REMOXY are reimbursed or paid for by Pfizer.  
  • We retain commercial rights to REMOXY in Australia/New Zealand. We have not yet announced a market entry strategy for these territories.

Conference Call

Pain Therapeutics will host a conference call today at 5:00 p.m. Eastern time to discuss 2013 financial results, provide guidance for 2014 and to respond to questions. 

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