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11/10/09 - Progenics Reports Q3 2009 Financial Results

TARRYTOWN, N.Y. - Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) 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.

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 (33% versus 0%, [p<0.05] and 39% versus 7%, [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.

About Subcutaneous RELISTOR: RELISTOR subcutaneous injection is approved in the United States for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The use of RELISTOR beyond four months has not been studied. The drug is also approved for use in over 30 countries worldwide, including the European Union, Canada, Australia and Brazil. Applications in additional countries are pending.

Important Safety Information for RELISTOR

RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician.

Use of RELISTOR has not been studied in patients with peritoneal catheters.

The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs. 5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%).

RELISTOR full Prescribing Information for the U.S. is available at www.relistor.com.

About Subcutaneous RELISTOR for OIC in the Chronic-pain Setting: In May 2009, Progenics and Wyeth reported a positive outcome from a 470-patient, phase 3 efficacy clinical trial in patients with chronic, non-cancer pain. This study showed statistically significant improvements in the occurrence of bowel movements with the use of RELISTOR. Adverse events observed in this study were similar to those seen in prior studies. Enrollment was also recently completed for phase 3 safety study of over 1,000 patients, with results expected by the end of 2010. Results from these two studies are expected to be included in an sNDA submission by early 2011. If FDA approval of the application is granted, Progenics plans to launch subcutaneous RELISTOR in a multi-dose pen for the chronic-pain OIC market thereafter.

About Progenics: Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward supportive care, virology and oncology. Progenics is developing RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced side effects. RELISTOR is currently approved in over 30 countries, including the U.S., E.U. member countries, Canada, Australia and Brazil; marketing applications are pending elsewhere throughout the world. Progenics is pursuing strategic alternatives for RELISTOR, including licensing, collaboration, strategic alliances and U.S. commercialization or co-promotion, following termination of its 2005 collaboration with Wyeth Pharmaceuticals, which is continuing manufacturing, sales, marketing, and certain development and regulatory activities for RELISTOR during the transition. Ono Pharmaceutical Co., Ltd. has an exclusive license from Progenics for development and commercialization of subcutaneous RELISTOR in Japan. In the area of virology, Progenics is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody which binds to co-receptor CCR5 to inhibit human immunodeficiency virus (HIV) infection. PRO 140 is currently in phase 2 clinical testing. The Company’s hepatitis C virus discovery program seeks to identify novel inhibitors of HCV entry. In oncology, the Company is conducting a phase 1 clinical trial of a human monoclonal antibody-drug conjugate (ADC) for the treatment of prostate cancer—a selectively targeted chemotherapeutic antibody directed against prostate-specific membrane antigen. PSMA is a protein found on the surface of prostate cancer cells as well as in blood vessels supplying other solid tumors. Progenics is also conducting phase 1 clinical trials with vaccines designed to treat prostate cancer by stimulating an immune response to PSMA.

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