Progenics Pharmaceuticals Announces Second Quarter 2014 Financial Results
Net loss for the quarter was
Second quarter revenue totaled
|Net Relistor Sales|
|Three Months Ended||Six Months Ended|
Second quarter research and development expenses decreased by
Second Quarter and Upcoming Events
The U.S. Food and Drug Administrationsaid on July 10that the sNDA expanding Relistor's indication to include chronic non-cancer pain patients with OIC can be approved on the data previously submitted in that filing. The decision follows Salix's appeal of the agency's Complete Response Letter on the filing two years ago and an Advisory Committee convened by the FDAlast month. Salix submitted to the agency on July 25information required for final approval, and we expect a two-month review.
Salix has said it intends to meet with the
FDAas soon as possible to discuss a path forward for oral Relistor for the treatment of OIC in patients with chronic, non-cancer pain.
Results from two trials of the Company's small molecule PSMA imaging agent for prostate cancer, 1404, are scheduled to be presented at a featured oral session during the annual meeting of the
European Association of Nuclear Medicine(EANM) in Gothenburg, Swedenon in October.
The phase 2 complete study results involving 104 patients are to be presented by Dr.
Gabriella Dabasiof Semmelweis University.
Shankar Vallabhajosulaof Cornell University's Medical Collegeis to present phase 1 pilot study results on nine patients.
- The phase 2 complete study results involving 104 patients are to be presented by Dr.
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 per share)|
|For the Three Months Ended||For the Six Months Ended|
|Royalty income||$ 1,367||$ 1,176||$ 2,102||$ 2,333|
|Research and development||7,848||9,585||14,767||18,300|
|License fees - research and development||180||153||270||223|
|General and administrative||4,256||3,899||8,161||8,219|
|Depreciation and amortization||133||318||277||595|
|Total other income||13||10||25||24|
|Net loss before income tax benefit||(11,074)||(12,263)||(20,387)||(23,521)|
|Income tax benefit||1||--||1||--|
|Net loss||$ (11,073)||$ (12,263)||$ (20,386)||$ (23,521)|
|Net loss per share; basic and diluted||$ (0.17)||$ (0.24)||$ (0.31)||$ (0.46)|
|Weighted average shares outstanding; basic and diluted||63,743||51,481||66,775||50,802|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$ 85,347||$ 65,860|
|Accounts receivable, net||1,468||2,879|
|Auction rate securities||2,208||2,208|
|Fixed assets, net||2,203||2,413|
|Intangible assets, net and goodwill||39,079||39,081|
|Total assets||$ 132,405||$ 114,541|
|Current liabilities||$ 4,352||$ 6,627|
|Contingent consideration liability||16,600||15,700|
|Deferred tax and other liabilities||13,232||13,235|
|Total liabilities and stockholders' equity||$ 132,405||$ 114,541|
Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor, to Salix Pharmaceuticals, Ltd. Relistor (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness.
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 or social media sites is not included in the company's
For more information, please visit www.progenics.com. Please follow us on LinkedIn®.
For more information about Relistor, please visit www.relistor.com.
Melissa DownsInvestor Relations (914) 789-2801 firstname.lastname@example.org
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