Progenics Pharmaceuticals reports financial results for the third quarter of 2009

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its results of operations for the third quarter and nine months ended September 30, 2009.

Financial Results

Net loss for the third quarter of 2009 was $13.0 million or $0.41, basic and diluted, per share, compared to $12.2 million or $0.40, basic and diluted, per share in the third quarter of 2008. Net loss for the nine months ended September 30, 2009 was $30.0 million or $0.97, basic and diluted, per share, compared to a net loss of $30.1 million or $1.00, basic and diluted, per share for the first nine months of 2008.

Revenues for the third quarter of 2009 totaled $5.4 million, compared to $17.5 million for the same period of 2008, reflecting a decrease in reimbursement revenue from Wyeth (NYSE: WYE) for RELISTOR^® research and development under the recently terminated 2005 collaboration between Wyeth and Progenics. For the first nine months of 2009, Progenics reported revenues of $31.8 million compared to $60.8 million for the comparable period of 2008. Revenues for nine months also reflect a decrease in reimbursement and milestone revenue from Wyeth, offset by recognition in the first quarter of a $15.0 million upfront payment received in 2008 from Ono Pharmaceutical Co., Ltd. (OSE-TYO: 4528), Progenics’ collaborator for subcutaneous RELISTOR in Japan.

Expenses for the third quarter of 2009 were $18.6 million, compared to $31.2 million for the same period in the previous year. For the nine months ended September 30, 2009, expenses totaled $63.5 million, compared to $95.9 million for the same period of 2008.

Progenics ended the quarter with cash, cash equivalents and marketable securities of $106.8 million, a reduction of $10.7 million from $117.5 million at June 30, 2009.

The decreases in expenses for the third quarter and nine months ended September 30, 2009 compared to 2008 were attributable primarily to decreases of $10.3 million and $29.9 million, respectively, in research and development expenses. The overall decreases, which reflect increases in PSMA-related clinical activities, resulted primarily from:

• Reduced RELISTOR development expenses following completion of Progenics-conducted clinical trials and other development work; and
• Reduced manufacturing activities for PRO 140 clinical trials.

Global net sales of RELISTOR for the third quarter of 2009 were $3.3 million, as compared to $3.2 million in sales for the previous quarter and $0.8 million for the third quarter of 2008 when RELISTOR had only been partially launched by Wyeth. Of the current period’s global net sales, U.S. net sales comprised $1.8 million, as compared with $2.0 million in the previous quarter.

“During the third quarter, we worked diligently to regain worldwide rights to RELISTOR, the only approved drug for opioid-induced constipation, and our announcement just after the closing of this quarter was a significant event,” said Paul J. Maddon, Founder, Chief Executive Officer and Chief Science Officer of Progenics Pharmaceuticals. “We are excited about the future of the RELISTOR franchise, including our plans to submit an sNDA by early 2011 for approval of subcutaneous RELISTOR for the treatment of opioid-induced constipation in the broader chronic-pain market and to take immediate responsibility for development of oral RELISTOR. We believe that RELISTOR is just beginning to realize its potential in the opioid-induced constipation marketplace.”

Third Quarter Highlights

• Applications for a new RELISTOR pre-filled syringe delivery system were submitted to the U.S. Food and Drug Administration and the European Union European Medicines Agency. Pre-filled syringes are designed to ease preparation and administration for patients and caregivers and, if approved, could be available to advanced-illness patients in the U.S. and Europe as early as the first half of 2010.
• Mark R. Baker, formerly Executive Vice President – Corporate, was appointed President and a member of the Board of Directors. He continues to report to Dr. Maddon. In his new role, Mr. Baker oversees business and commercial development, strategic planning, investor relations, corporate communications, finance and accounting, operations and legal affairs.

October Highlights

• Progenics and Wyeth terminated their 2005 collaboration, and Progenics is regaining all worldwide rights to the RELISTOR franchise. Progenics will assume full control of future development and commercialization of subcutaneous RELISTOR after a transition period, and is taking over clinical and non-clinical development of the oral form of the drug. Wyeth has agreed to pay Progenics a total of $10.0 million in installments through January 2011, and to provide support by continuing manufacturing, marketing, sales, distribution, ongoing clinical studies and regulatory activities for subcutaneous RELISTOR over the transitional period. Wyeth is also committing up to $14.5 million of funding for development of RELISTOR in a multi-dose pen delivery system for the chronic-pain patient population and for pediatric clinical trials. Progenics’ out-license of subcutaneous RELISTOR to Ono Pharmaceutical in Japan is not affected by the Wyeth collaboration termination.
• Positive data from a phase 2 study of methylnaltrexone treatment during rehabilitation following orthopedic procedures was presented at the annual meeting of the American Academy of Physical Medicine and Rehabilitation. The hypothesis-generating study was conducted by Progenics in 33 patients and served to evaluate methylnaltrexone in a new patient setting. Significantly more patients on study drug experienced laxation within two and four hours compared to those on placebo (39% versus 7%, [p<0.05] and 33% versus 0%, [p<0.05], respectively). In addition, the median time to laxation in the methylnaltrexone group was nearly one day earlier than the placebo group. Incidences of adverse events were comparable between the two treatment groups, and no serious adverse events were reported. Data from this study will support the safety portion of the chronic-pain sNDA planned for FDA submission by early 2011.