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Progenics Pharmaceuticals Announces Fourth Quarter And Year-End 2010 Financial Results

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.”

Recent Highlights
  • 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,
2010       2009 2010       2009
Revenues:
Research and development $ 238 $ 15,145 $ 1,413 $ 44,351
Royalty income - 1,396 1,826 2,372
Research grants 1,906 547 4,573 1,968
Other revenues 13 67 140 256
Total revenues 2,157 17,155 7,952 48,947
 
Expenses:
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
Royalty expense 59 139 241 237
Depreciation and amortization 570 1,445 2,853 5,078
Total expenses 21,068 17,818 77,836 81,277
 
Operating loss (18,911 ) (663 ) (69,884 ) (32,330 )
 
Other income:
Interest income 16 24 64 1,481
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 $ (18,800 ) $ (639 ) $ (69,725 ) $ (30,612 )
 
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
Accounts receivable 2,283 7,522
Marketable and auction rate securities 3,608 5,293
Fixed assets, net 5,878 6,560
Other assets 3,051 3,335
Total assets $ 62,738 $ 113,613
 
Liabilities $ 11,430 $ 6,006
Stockholders’ equity 51,308 107,607
Total liabilities and stockholders’ equity $ 62,738 $ 113,613

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 50 countries worldwide, including the European Union, Canada and Australia. Applications in additional countries are pending.

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