Progenics Pharmaceuticals Announces Third Quarter 2010 Financial Results
Net loss for the third quarter of 2010 was
Progenics ended the third quarter of 2010 with cash, cash equivalents
and marketable securities of
Third quarter revenue totaled
Progenics receives royalties from its former collaborator Pfizer on all
global net sales of RELISTOR, the Company's drug approved for the
treatment of opioid-induced constipation in advanced-illness patients.
For the third quarter of 2010, global net sales of RELISTOR were
Global net sales of RELISTOR for the first nine months of 2010 were
Expenses for the third quarter of 2010 were
For the first nine months of 2010, expenses totaled
Progenics continues to pursue a range of strategic options 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. The Company is also pursuing strategic collaborations with biopharmaceutical companies for development of PSMA ADC.
"The RELISTOR brand lifecycle advanced significantly in the third
Third Quarter Highlights
|The study is evaluating the safety and efficacy of oral methylnaltrexone in patients with chronic, non-cancer pain who are experiencing constipation as a result of their opioid-pain medications.|
|The one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection enrolled 1,034 patients with chronic, non-malignant pain and opioid-induced constipation. Progenics plans to include results from this study in a supplemental New Drug Application to be submitted to the FDA in the first half of 2011.|
|Wyeth is now continuing to market and sell RELISTOR in the U.S. through December 31, 2010 and ex-U.S. through March 31, 2010, subject to extension and early termination options available to us. During these extension periods, royalties will not be payable to us.|
|The pre-filled syringes, available in 8 mg and 12 mg doses, will provide a simplified dosing option for the treatment of opioid-induced constipation in palliative-care patients with advanced illness. RELISTOR in single-use vials will continue to be available primarily for institutional use.|
Progenics presented preclinical data on novel monoclonal antibodies against toxins produced by the bacterium Clostridium difficile (C. difficile) at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston.
|Vivien Wong, Ph.D. was promoted to Vice President, Product Development, with responsibility for preclinical development, clinical pharmacology, and project management.|
Progenics has been awarded a three-year NIH grant totaling $4.1 million in support of research and pre-clinical development of its humanized monoclonal antibodies against the disease-causing toxins produced by C. difficile. The Company also has been awarded $730,000 as part of the U.S. Government's Qualifying Therapeutic Discovery Project, which provides grants or tax credits for 2009 and 2010 research aimed at creating new therapies, reducing long-term healthcare costs, and/or significantly advancing the goal of curing cancer within the next 30 years.
PROGENICS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except net loss per share)
For the Three Months Ended
For the Nine Months Ended
|Research and development||$||82||$||4,431||$||1,175||$||29,206|
|Research and development||12,967||11,318||35,518||39,009|
|License fees — research and development||110||136||1,217||961|
|General and administrative||5,414||5,844||17,568||19,758|
|Depreciation and amortization||532||1,207||2,283||3,633|
|Gain on sale of marketable securities||-||-||-||237|
|Total other income||17||123||48||1,694|
|Net loss per share; basic and diluted||$||(0.52)||$||(0.41)||$||(1.57)||$||(0.97)|
|Weighted average shares outstanding;|
|basic and diluted||32,814||31,428||32,444||31,060|
CONDENSED CONSOLIDATED BALANCE SHEETS
|September 30, 2010||December 31, 2009|
|Cash and cash equivalents||$||58,394||$||90,903|
|Fixed assets, net||6,404||6,560|
|Total liabilities and stockholders' equity||$||75,946||$||113,613|
About Subcutaneous RELISTOR
RELISTOR subcutaneous injection is approved in
Important Safety Information for RELISTOR
- RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction
- If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician
- Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients. Use RELISTOR with caution in patients with known or suspected lesions of the GI tract
- Use of RELISTOR has not been studied in patients with peritoneal catheters
- The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs. 5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%)
- Safety and efficacy of RELISTOR have not been established in pediatric patients
RELISTOR full Prescribing Information for the U.S. is available at www.relistor.com.
RELISTOR 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. Use of RELISTOR beyond 4 months has not been studied.
PROGENICS DISCLOSURE NOTICE: 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; competing products currently on the market or in development might reduce the commercial potential of our products; 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; potential product liability; intellectual property, litigation, environmental and other risks; the risk that we may not be able to enter into favorable collaboration or other relationships or that existing or future relationships may not proceed as planned; the risk that current and pending patent protection for our products may be invalid, unenforceable or challenged, or fail to provide adequate market exclusivity, or that our rights to in-licensed 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
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. 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, please visit www.progenics.com.
For more information about RELISTOR, please visit www.RELISTOR.com.
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