TARRYTOWN, N.Y., Mar 13, 2009 (BUSINESS WIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its results of operations for the fourth quarter and year ended December 31, 2008.
Revenues for the fourth quarter totaled $6.8 million, compared to $15.5 million for the same period of 2007. For the year ended December 31, 2008, the Company reported revenues of $67.7 million compared to $75.6 million for the comparable period of 2007.
Progenics ended the year 2008 with cash, cash equivalents and marketable securities of $141.4 million, compared to $170.4 million at December 31, 2007.
"Progenics had a pivotal year in 2008 - most significantly with the approval of RELISTOR(R), our first commercial product, by the U.S. Food and Drug Administration," said Paul J. Maddon, M.D., Ph.D., Progenics' Founder, Chief Executive Officer and Chief Science Officer. "RELISTOR is now approved in over 30 countries including the U.S., Canada, Australia and all member states of the European Union, and we are receiving royalties on worldwide sales. In addition, we made significant progress in advancing product candidates in our pipeline, completing two phase 2 trials of PRO 140 for the treatment of HIV infection, initiating the first clinical study of our PSMA antibody-drug conjugate for prostate cancer, and selecting PRO 206, a novel viral-entry inhibitor for the treatment of hepatitis C infection, for clinical development."
"Progenics has historically been efficient in managing its capital and has not incurred debt," Dr. Maddon continued. "In these challenging economic times, we will continue controlling expenses while carefully deploying existing cash, government funding and royalty proceeds for product development. We are guided by a conservative fiscal strategy in seeking non-dilutive sources of funding, including alliances to help us support our development programs."
Revenues for the three months and years ended December 31, 2008 and 2007 reflect:
Expenses for the fourth quarter of 2008 were $22.6 million, compared to $33.2 million for the fourth quarter of 2007. For the year ended December 31, 2008, expenses totaled $118.6 million, compared to $127.1 million for the same period of 2007.
Research and development expenses, including license fees and royalty expense, decreased $11.0 million, both for the fourth quarter of 2008 and the year ended December 31, 2008, compared to the same periods of 2007. The fourth quarter 2008 decrease in research and development expenses resulted primarily from a decrease in activity related to the RELISTOR, PRO 140 and PSMA clinical programs, partially offset by an increase in license fees. For the year ended December 31, 2008, research and development expenses decreased, primarily from a decrease in activity related to the PSMA clinical program, and to a lesser extent, activity related to the HCV research program, partially offset by increased activity in the PRO 140 clinical program and increased headcount.
General and administrative expenses increased for the three months and for the year ended December 31, 2008, compared to the same periods of 2007. The fourth quarter 2008 increase in general and administrative expenses was primarily due to an increase in consulting expenses, partially offset by decreases in operating expenses and share-based compensation. For the year ended December 31, 2008, general and administrative expenses increased primarily due to increased headcount, consulting and professional fees, partially offset by decreases in operating expenses and share-based compensation.
Fourth quarter 2008 net loss was $14.6 million, compared to a net loss of $15.3 million for the same period of 2007. Net loss per share was $0.49, basic and diluted, for the fourth quarter of 2008, compared to net loss per share of $0.53, basic and diluted, for the same period of 2007. The net loss for the year ended December 31, 2008 was $44.7 million, compared to a $43.7 million net loss for the same period of 2007. Net loss per share for the year ended December 31, 2008 was $1.51, basic and diluted, compared to net loss per share of $1.60, basic and diluted, for the same period of 2007.
In April 2008, Progenics' Board of Directors approved a share repurchase program to acquire up to $15.0 million of the Company's outstanding common stock, funding for which came from the $15.0 million milestone payment from Wyeth for receipt of U.S. marketing approval for subcutaneous RELISTOR. Progenics repurchased 200,000 shares during the year ended December 31, 2008 for a total purchase price of $2.7 million.
2008 Company Highlights
RELISTOR Program Developments
Expected Developments in Proprietary Programs
About Progenics' Collaboration with Wyeth
In December 2005, Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals, Inc. entered into an exclusive, worldwide agreement for the joint development and commercialization of methylnaltrexone for the treatment of opioid-induced side effects.
In January 2009, Wyeth and Pfizer Inc. executed a definitive agreement under which Pfizer is to acquire Wyeth. The proposed acquisition of Wyeth by Pfizer, which is subject to closing conditions, does not trigger any change-of-control provisions in our collaboration with Wyeth, and we believe that if the acquisition occurs, the combined Pfizer/Wyeth organization will continue to have the same rights and responsibilities under the collaboration agreement following the acquisition as Wyeth had before.
About Progenics' Collaboration with Ono
In October 2008, Ono Pharmaceutical Co., Ltd. and Progenics Pharmaceuticals, Inc. entered into an exclusive license agreement under which Ono has acquired the rights to subcutaneous RELISTOR in Japan, where it plans to develop and commercialize the U.S.-approved drug for the treatment of opioid-induced constipation. RELISTOR is being developed and commercialized in the rest of the world by Progenics and Wyeth Pharmaceuticals, a division of Wyeth, and is approved in over 30 countries.
About the Company
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-including human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections-and oncology. Progenics, in collaboration with Wyeth, is developing RELISTOR(R) (methylnaltrexone bromide) for the treatment of opioid-induced side effects. Wyeth has worldwide rights to develop and commercialize all forms of RELISTOR, except in Japan where Progenics has granted Ono Pharmaceutical Co., Ltd. an exclusive license to the subcutaneous form of RELISTOR for development and commercialization in that country. RELISTOR is currently approved in over 30 countries, including the U.S., Canada, Australia and all European Union member states. In the U.S., RELISTOR (methylnaltrexone bromide) subcutaneous injection is indicated 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. Marketing applications are pending for RELISTOR in other countries. In the area of virology, Progenics is developing the HIV entry inhibitor PRO 140, a humanized monoclonal antibody targeting the entry co-receptor CCR5, which is currently in phase 2 clinical testing. The Company is also developing a novel HCV entry inhibitor, PRO 206. For the treatment of prostate cancer, Progenics is conducting a phase 1 clinical trial of a human monoclonal antibody-drug conjugate (ADC) designed to selectively target prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells as well as in blood vessels supplying non-prostatic solid tumors. Progenics is also conducting phase 1 clinical trials with vaccines designed to treat prostate cancer by stimulating an immune response to PSMA.
(Financial Tables Follow)
PROGENICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except net loss per share)
For the Three Months Ended
For the Year Ended
|Research and development from collaborator||$||4,989||$||12,468||$|
|Research grants and contract||1,771||2,999||7,460||10,075|
|Research and development||14,099||26,068||82,290||95,234|
|License fees - research and development||1,042||109||2,830||942|
|General and administrative||6,304||6,154||28,834||27,901|
|Depreciation and amortization||1,182||883||4,609||3,027|
|Net loss per share; basic and diluted||$||(0.49||)||$||(0.53||)||$||(1.51||)||$||(1.60||)|
|Weighted average shares outstanding; basic and diluted||29,953||29,570||29,654||27,378|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|December 31, 2008||December 31, 2007|
|Cash, cash equivalents and marketable securities||$||141,374||$||170,370|
|Fixed assets, net||11,071||13,511|
|Total liabilities and stockholders' equity||$||157,833||$||189,539|
This document contains statements that do not relate strictly to historical fact, any of which may be forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. When we use the words "anticipates," "plans," "expects" and similar expressions, we are identifying forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. While it is impossible to identify or predict all such matters, these differences may result from, among other things, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and product candidates, including the risks that clinical trials will not commence or proceed as planned; products appearing promising in early trials will not demonstrate efficacy or safety in larger-scale trials; clinical trial data on our products and product candidates will be unfavorable; our products will not receive marketing approval from regulators or, if approved, do not gain sufficient market acceptance to justify development and commercialization costs; we, our collaborators or others might identify side effects after the product is on the market; or efficacy or safety concerns regarding marketed products, whether or not originating from subsequent testing or other activities by us, governmental regulators, other entities or organizations or otherwise, and whether or not scientifically justified, may lead to product recalls, withdrawals of marketing approval, reformulation of the product, additional pre-clinical testing or clinical trials, changes in labeling of the product, the need for additional marketing applications, declining sales or other adverse events.
We are also subject to risks and uncertainties associated with the actions of our corporate, academic and other collaborators and government regulatory agencies, including risks from market forces and trends, such as those relating to the recently-announced acquisition of our RELISTOR(R) collaborator, Wyeth Pharmaceuticals, by Pfizer, Inc.; potential product liability; intellectual property, litigation, environmental and other risks; the risk that licenses to intellectual property may be terminated for our failure to satisfy performance milestones; the risk of difficulties in, and regulatory compliance relating to, manufacturing products; and the uncertainty of our future profitability.
Risks and uncertainties also include general economic conditions, including interest and currency exchange-rate fluctuations and the availability of capital; changes in generally accepted accounting principles; the impact of legislation and regulatory compliance; the highly regulated nature of our business, including government cost-containment initiatives and restrictions on third-party payments for our products; trade buying patterns; the competitive climate of our industry; and other factors set forth in our Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission. In particular, we cannot assure you that RELISTOR will be commercially successful or be approved in the future in other formulations, indications or jurisdictions, or that any of our other programs will result in a commercial product.
We do not have a policy of updating or revising forward-looking statements, and we assume no obligation to update any statements as a result of new information or future events or developments. Thus, it should not be assumed that our silence over time means that actual events are bearing out as expressed or implied in forward-looking statements.
For more information about Progenics Pharmaceuticals, Inc., please visit www.progenics.com.
SOURCE: Progenics Pharmaceuticals, Inc.
Progenics Pharmaceuticals, Inc.
Richard W. Krawiec, Ph.D., 914-789-2814
Vice President, Corporate Affairs
Dory A. Lombardo, 914-789-2818
Associate Director, Corporate Affairs
Aline Schimmel, 312-646-6295
Barri Winiarski, 914-584-7468
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