Expenses for the fourth quarter of 2010 were $21.1 million, up $3.3 million over the same period in 2009. The increase resulted from clinical trial expenses incurred in the oral methylnaltrexone phase 3 study and consultants’ expenses and contract manufacturing costs for new delivery system development for subcutaneous RELISTOR. This increase was partially offset by lower compensation expenses resulting from a decrease in Company-wide average headcount and lower contract manufacturing and product testing expenses for PSMA ADC. For the full year, expenses totaled $77.8 million, down $3.4 million from 2009, as a result of lower compensation expenses, manufacturing, laboratory and product testing costs for PSMA ADC and PRO 140, and PRO 140 clinical trial expenses, partially offset by clinical trial, consulting and contract manufacturing expenses.
“Year-end 2010 and early 2011 marked an important inflection point in Progenics’ evolution,” said Mark R. Baker, Progenics’ Chief Executive Officer. “Our first commercial product, RELISTOR, is now licensed to two outstanding partners for continued development and commercialization in markets worldwide. In May, we will present safety data from a phase 3 trial of subcutaneous RELISTOR in chronic pain, and we are on track to submit a supplemental NDA for this indication in the second quarter of this year. We also presented preliminary positive data from our ongoing phase 1 study of PSMA ADC for prostate cancer at the recent ASCO Genitourinary Cancers Symposium.”
- Progenics licenses RELISTOR to Salix Pharmaceuticals
Salix Pharmaceuticals (Nasdaq: SLXP) will now further develop and commercialize subcutaneous RELISTOR worldwide, other than Japan, directly through its specialty sales force in the U.S. and with sublicenses to regional companies ex-U.S. Salix is responsible for completing clinical development necessary to support regulatory marketing approvals for potential new indications and formulations, and marketing and selling the product. Progenics received a $60.0 million upfront payment from Salix in February and is eligible to receive potential U.S. development and sales based milestones up to $290.0 million, royalties on net sales by Salix and 60% of net revenue received from ex-U.S. sublicensees. Wyeth is continuing to distribute RELISTOR in the U.S. through March 31, 2011 and the parties are discussing ex-U.S. transition on a country-by-country basis, as responsibility for the franchise is transferred to Salix.
|PROGENICS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except net loss per share)|
|For the Three Months Ended December 31,||For the Year Ended December 31,|
|Research and development||$||238||$||15,145||$||1,413||$||44,351|
|Research and development||15,122||10,775||50,640||49,798|
|License fees – research and development||53||97||1,270||1,058|
|General and administrative||5,264||5,362||22,832||25,106|
|Depreciation and amortization||570||1,445||2,853||5,078|
|Gain on sale of marketable securities||-||-||-||237|
|Total other income||16||24||64||1,718|
|Net loss before income taxes||(18,895||)||(639||)||(69,820||)||(30,612||)|
|Income tax benefit||95||-||95||-|
|Net loss per share; basic and diluted||$||(0.57||)||$||(0.02||)||$||(2.14||)||$||(0.98||)|
|Weighted-average shares outstanding; basic and diluted||33,031||31,688||32,590||31,219|
|CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands)|
|December 31, 2010||December 31, 2009|
|Cash and cash equivalents||$||47,918||$||90,903|
|Marketable and auction rate securities||3,608||5,293|
|Fixed assets, net||5,878||6,560|
|Total liabilities and stockholders’ equity||$||62,738||$||113,613|
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