Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its results of operations for the quarter ended March 31, 2010.
“The first quarter has been an active one at Progenics”
Financial Results
Net loss for the first quarter of 2010 was $18.6 million or $0.58, basic and diluted, per share, compared to $1.8 million or $0.06, basic and diluted, per share in the first quarter of 2009. Progenics ended the quarter with cash, cash equivalents and marketable securities of $84.7 million, reflecting use of cash of $11.5 million in the quarter.
First quarter revenue of $1.5 million reflected a decrease in research and development revenue from Wyeth, now a Pfizer, Inc. (NYSE: PFE) subsidiary, from the same period of 2009, in which the Company also recognized a $15.0 million upfront payment from Ono Pharmaceutical Co., Ltd. (OSE-TYO: 4528), Progenics' collaborator for subcutaneous RELISTOR® (methylnaltrexone bromide) in Japan. The decreased research and development revenue resulted from termination of the 2005 Progenics-Wyeth collaboration pursuant to the 2009 transition agreement. Revenue for the 2009 period was $20.9 million.
Expenses for the first quarter of 2010 were $20.1 million compared to $23.5 million for the same period in the previous year. The decrease was attributable primarily to lower compensation expenses resulting from a decrease in average headcount Company-wide, reduced manufacturing expenses for PRO 140, completion of manufacturing for PSMA ADC phase 1 clinical supplies and reduced expenses for PSMA raw material-related research supplies, partially offset by increases in PSMA-related clinical activities and RELISTOR manufacturing expenses for the multi-dose pen.
Global net sales of RELISTOR for the first quarter of 2010 were $4.2 million, a 6% increase over the $3.9 million for the previous quarter and a 123% increase over the $1.9 million for the first quarter of 2009. U.S. net sales were $2.4 million, a 15% increase over the $2.1 million for the previous quarter and a 103% increase over the $1.2 million for the first quarter of 2009. Ex-U.S. RELISTOR net sales were $1.8 million in both the first quarter of 2010 and the previous quarter, an increase of 158% over the $0.7 million for the first quarter of 2009.
"The first quarter has been an active one at Progenics," said Paul J. Maddon, Founder, Chief Executive and Chief Science Officer. "We continue discussions with potential partners for the RELISTOR franchise while we plan for the entry of oral RELISTOR into pivotal clinical testing. We are also assessing the safety and activity of our lead development candidate PSMA ADC in a phase 1 clinical trial and this will allow us to determine a maximum tolerated dose. We will continue to keep shareholders apprised of these initiatives in the coming quarters."
First Quarter 2010 Highlights
- Progenics announced plans to commence a phase 2b/3 clinical trial of oral methylnaltrexone in chronic-pain patients during the second half of 2010 using tablets manufactured by Wyeth under the 2009 transition agreement. This followed an analysis of complete data from the previously reported pilot clinical trial in chronic, non-cancer pain patients, in which 48% of the 25 patients receiving one of the oral methylnaltrexone doses after an overnight fast laxated within four hours of treatment.
- The Company presented data from preclinical studies of novel multiplex PI3-Kinase inhibitors at the American Association for Cancer Research's Conference on Protein Translation and Cancer. In laboratory studies, these synthetic small-molecule compounds identified by Progenics blocked both phosphoinositide 3-kinase, a key regulator of one molecular signaling pathway, and MNK, an oncogenic kinase in the Ras pathway. Progenics believes simultaneously blocking these interlinked cellular pathways with a single agent may provide a strategy to combat some of the most aggressive forms of cancer.
- Progenics is awaiting FDA and EMEA action for RELISTOR in pre-filled syringes and, if approved, plans to coordinate the launch with a new commercialization partner.