Progenics Pharmaceuticals Announces Second Quarter 2012 Financial Results
Net loss for the quarter was
Second quarter revenue totaled
Net sales reported by Progenics' Relistor collaborators were:
|Relistor Net Sales Reported by Collaborators (millions)|
|Three Months Ended||Six Months Ended|
||$ 21.3||$ 5.3|
||$ 23.1||$ 8.5|
Second quarter and year-to-date research and development expenses decreased by
Recent and Second Quarter Events
July 27, Progenics and Salix announced that the FDAissued a Complete Response Letter (CRL) following its review of a supplemental New Drug Application for subcutaneous Relistor in adult patients with chronic, non-cancer pain. Salix has requested an End-of-Review meeting with the FDAto better understand the contents of the CRL.
Second quarter 2012 Relistor global net sales increased 109% over second quarter 2011, and decreased 12% from the first quarter 2012. First half 2012 Relistor global net sales increased 173% over the same period in the prior year.
The company presented at the
American Society of Clinical Oncology(ASCO) 2012 meeting a summary of interim results from its phase 1 study of PSMA ADC.
Conference Call and Webcast
Progenics will review second quarter financial results in a conference call today at
- Financial Tables follow -
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except net (loss) income per share)|
For the Three Months Ended
For the Six Months Ended
|Research and development||7,957||13,302||18,866||32,481|
|License fees — research and development||110||88||150||452|
|General and administrative||4,025||4,952||7,746||10,149|
|Depreciation and amortization||300||525||772||1,061|
|Operating (loss) income||(10,734)||55,470||(23,835)||32,525|
|Total other income||14||16||29||34|
|Net (loss) income||$ (10,720)||
|Net (loss) income per share; basic||$ (0.32)||
|Weighted average shares outstanding; basic||33,798||33,510||33,779||33,397|
|Net (loss) income per share; diluted||$ (0.32)||
|Weighted average shares outstanding; diluted||33,798||33,787||33,779||33,567|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||
|Auction rate securities||3,240||3,332|
|Fixed assets, net||3,915||4,038|
|Total liabilities and stockholders' equity||
Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor, to Salix Pharmaceuticals, Ltd. for markets worldwide other than
Important Safety Information for subcutaneous Relistor
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 four months has not been studied.
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. Use of Relistor has not been studied in patients with peritoneal catheters.
Safety and efficacy of Relistor have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).
Use Relistor with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with Relistor and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.
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%).
Relistor full Prescribing Information for the U.S. is available at www.relistor.com.
This press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its
website, and in its press releases and reports it files with the
Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release.
For more information, please visit www.progenics.com.
For more information about Relistor, please visit www.relistor.com.
Amy MartiniCorporate Affairs (914) 789-2816 firstname.lastname@example.org
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