Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its results of operations for the second quarter and six months ended June 30, 2010.
“We finalized the design prototype for a multi-dose pen, another more convenient means of administering RELISTOR and the next planned presentation of the product in its commercial life cycle. We also remain on track to begin pivotal testing of our oral RELISTOR candidate in the second half of 2010.”
Net loss for the second quarter of 2010 was $15.2 million or $0.47, basic and diluted, per share, compared to $15.2 million or $0.49, basic and diluted, per share in the second quarter of 2009. Net loss for the six months ended June 30th was $33.8 million or $1.05, basic and diluted, per share, compared to $17.0 million or $0.55, basic and diluted, per share for the first half of 2009.
Progenics ended the second quarter of 2010 with cash, cash equivalents and marketable securities of $73.6 million, reflecting use of cash of $11.1 million in the quarter, in line with use of cash for the first quarter of 2010, and $22.6 million for the first six months of 2010.
Second quarter revenue totaled $2.3 million, compared to $5.5 million for the same period of 2009, reflecting a decrease in research and development revenue from Wyeth, now a Pfizer Inc. (NYSE: PFE) subsidiary, resulting from the wind down of the Progenics-Wyeth RELISTOR® collaboration. For the first half of 2010, Progenics reported revenues of $3.8 million, compared to $26.4 million for the same period in 2009, reflecting decreased research and development revenue and recognition in the first quarter of 2009 of a $15.0 million upfront payment from Ono Pharmaceutical Co., Ltd. (OSE-TYO: 4528), Progenics' collaborator for subcutaneous RELISTOR® (methylnaltrexone bromide) in Japan.
Progenics receives royalties from its former collaborator Pfizer on all global net sales of RELISTOR. For the second quarter of 2010, global net sales of RELISTOR, the Company's drug approved for the treatment of opioid-induced constipation in advanced-illness patients, were $3.8 million compared to $4.2 million for the previous quarter and $3.2 million for the second quarter of 2009. U.S. net sales were $2.3 million compared to $2.4 million for the previous quarter and $2.0 million for the same period last year. Ex-U.S. RELISTOR net sales were $1.5 million compared to $1.8 million for the previous quarter and $1.2 million for the same period last year.
Global net sales of RELISTOR for the first half of 2010 were $8.0 million comprised of U.S. and ex-U.S. net sales of $4.7 million and $3.3 million, respectively.
Expenses for the second quarter of 2010 were $17.6 million, $3.8 million less than the $21.4 million for the same period in 2009. For the first half of 2010, expenses totaled $37.7 million, a decrease of $7.2 million from $44.9 million for the same period last year. These decreases in expenses were attributable primarily to lower compensation expenses resulting from a Company-wide decrease in average headcount, reduced manufacturing expenses for PRO 140 and completion of manufacturing for PSMA ADC phase 1 clinical trials, partially offset by an increase in subcutaneous RELISTOR contract manufacturing expenses for the multi-dose pen.
Progenics continues to pursue a range of strategic alternatives for RELISTOR, including licensing, collaboration and/or strategic alliances with worldwide or regional partners, U.S. commercialization of the currently-approved product on its own or with pharmaceutical detailing and sales organizations and/or co-promotion of the franchise with a partner using its own sales force.
"During the second quarter, we made good progress in our discussions with potential partners for the RELISTOR franchise," said Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive and Chief Science Officer. "We finalized the design prototype for a multi-dose pen, another more convenient means of administering RELISTOR and the next planned presentation of the product in its commercial life cycle. We also remain on track to begin pivotal testing of our oral RELISTOR candidate in the second half of 2010."
Second Quarter Highlights and Recent Updates
- Europe's CHMP Issues Positive Opinion for RELISTOR in Pre-filled Syringes
The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on marketing approval for RELISTOR in pre-filled syringes. Progenics awaits a final decision from the European Commission as well as FDA action on the related U.S. regulatory application, and expects that pre-filled syringe commercial launches would occur in the United States and European Union in the second quarter of 2011.
- Recent Company Presentations:
Preclinical data on novel monoclonal antibodies against toxins produced by the bacterium Clostridium difficile (C. difficile) was presented at the 110th General Meeting of the American Society for Microbiology in San Diego.
The design and rationale of an ongoing phase 1 trial of Progenics' prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) therapy was presented in the newly devised 'Trials in Progress' session at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Director Peter J. Crowley was elected Chairman of the Board at Progenics' Annual Meeting. Mr. Crowley has over two decades of finance and advisory experience as a senior investment banker in the healthcare and life sciences industry.
Thomas Boyd, Progenics' Senior Vice President of Product Development, has announced his retirement, effective later this month. Dr. Boyd will remain a consultant to the Company, providing support and guidance for key activities. "We are grateful for Tom's long tenure with Progenics, and wish him well in his retirement," said Dr. Maddon. "We are especially pleased that he will be continuing with us as a consultant, and in particular, will continue to provide support for the planned filing of the sNDA for RELISTOR in the non-cancer pain setting."
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