Progenics Pharmaceuticals Announces Third Quarter Financial Results
Net loss for the quarter was
Third quarter revenue totaled
|Three Months Ended||Nine Months Ended|
Third quarter research and development expenses totaled
Third Quarter and Recent Events
The company completed enrollment in its phase 2 study of MP-1404, a PSMA imaging agent.
The company presented data on two of its PSMA-focused technologies, at the European Association of Nuclear Medicine (EANM) Annual Congress in
Lyon, France( October 21), and at the AACR-NCI-EORTC International Conference on Molecular Targetsand Cancer Therapeutics in Boston( October 19— 23).
The U.S. Food and Drug Administrationplans to convene on March 10-11, 2014an Advisory Committee to consider Salix's supplemental New Drug Application (sNDA) for Relistor (methylnaltrexone bromide) Subcutaneous Injection for opioid-induced constipation in patients with chronic pain.
Relistor global net sales decreased 39% from the second quarter and 1% from the third quarter of 2012. Global gross sales were nearly flat as compared to the second quarter and increased more than 80% versus third quarter 2012.
Progenics completed the sale of an additional 1.275 million shares from the underwriters' overallotment option in its June follow-on financing, yielding
$5.2 millionadditional net proceeds.
Michael D. Kishbauchwas elected to the company's board of directors and Stephen P. Goff, a director since 1993, retired.
Conference Call and Webcast
Progenics will review third quarter financial results in a conference call today at 8:30 a.m. EST. To participate, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 92604931. A live webcast will be available in the Media Center of the Progenics website, www.progenics.com, and a replay will be available there for two weeks.
- Financial Tables follow -
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except net loss per share)|
|For the Three Months Ended||For the Nine Months Ended|
|Royalty income||$ 719||$ 728||$ 3,052||$ 4,181|
|Research and development||7,913||7,551||26,702||26,417|
|License fees — research and development||91||510||314||660|
|General and administrative||3,123||4,007||10,853||11,753|
|Depreciation and amortization||179||291||774||1,063|
|Total other income||12||14||36||43|
|Net loss||$ (10,500)||$ (11,301)||$ (34,021)||$ (35,107)|
|Net loss per share; basic and diluted||$ (0.17)||$ (0.33)||$ (0.63)||$ (1.04)|
|Weighted average shares outstanding; basic and diluted||60,599||33,848||54,104||33,803|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$ 75,597||$ 58,838|
|Auction rate securities||2,208||3,240|
|Fixed assets, net||2,526||3,399|
|Intangible assets and goodwill||40,002||--|
|Total assets||$ 122,458||$ 76,308|
|Current liabilities||$ 6,072||$ 8,662|
|Acquisition-related contingent consideration liability||15,900||--|
|Deferred tax and other liabilities||13,598||1,078|
|Total liabilities and stockholders' equity||$ 122,458||$ 76,308|
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.
Information on or accessed through our website is not included in the company's
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 Kathleen FredriksenCorporate Development (914) 789-2871 email@example.com
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