Progenics Pharmaceuticals Announces Third Quarter 2012 Financial Results
Net loss for the third quarter of 2012 was
Third quarter revenue totaled
Net sales reported by Progenics' Relistor collaborators (in millions):
|Three Months Ended||Nine Months Ended|
|U.S.||$ 3.8||$ 8.2||
||$ 25.1||$ 13.5|
|Global||$ 4.9||$ 9.7||
||$ 28.0||$ 18.2|
Third quarter and year-to-date research and development expenses decreased by
Third Quarter and Recent Events
As previously announced, on
July 27the FDAissued a Complete Response Letter (CRL) requesting additional clinical data for the supplemental New Drug Application (sNDA) for Relistor (methylnaltrexone bromide) injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. On October 5, an End-of-Review meeting was held with the FDA's Division of Gastroenterology and Inborn Errors Productsto better understand the contents of the letter. The Division has expressed a concern that there may be a risk associated with the chronic use of mu-opioid antagonists in patients who are taking opioids for chronic pain. In order to understand this potential risk, the FDA'sDivision has communicated that a very large, well-controlled, chronic administration trial will have to be conducted to assess the safety of any mu-opioid antagonist prior to market approval for the treatment of patients with OIC who are taking opioids for chronic, non-cancer pain. Salix has held discussions with the Division and has expressed the view that the post-marketing, clinical and preclinical data currently available for Relistor adequately demonstrate an appropriate and expected safety profile sufficient to permit the approval of the current Relistor sNDA.
Salix and Progenics plan to continue to work with the
FDAto generate a reasonable path forward for the further development and regulatory review of Relistor that can be agreed upon by the parties. While it is not possible to determine definitively the duration of discussions with the FDAregarding this matter, at this time Salix and Progenics anticipate a path forward could be reached with the FDAduring 2013.
Third quarter Relistor global net sales decreased 50% from third quarter 2011, and decreased 55% from the second quarter 2012. First nine months Relistor global net sales increased 53% over the same 2011 period.
Progenics opened enrollment in a phase 2 study of its PSMA ADC compound in prostate cancer patients. The trial is an open-label, multicenter study to assess the anti-tumor activity (measured by prostate specific antigen; circulating tumor cells; bone, visceral and nodal metastases; and pain), tolerability and safety of PSMA ADC in up to 75 subjects with metastatic castration-resistant prostate cancer.
In a companywide restructuring, the Company reduced its workforce and terminated several early stage research projects. Clinical development and manufacturing capabilities were unaffected by this restructuring.
In October, Progenics completed the divestment of the PRO 140 program, receiving
$3.5 millionin cash, together with rights to receive additional milestone and royalty payments.
Conference Call and Webcast
Progenics will review third 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 Nine Months Ended
|Research and development||7,551||12,406||26,417||44,887|
|License fees — research and development||510||114||660||566|
|General and administrative||4,007||4,064||11,753||14,213|
|Depreciation and amortization||291||520||1,063||1,581|
|Operating (loss) income||(11,315)||(11,447)||(35,150)||21,078|
|Total other income||14||15||43||49|
|Net (loss) income||
|Net (loss) income per share; basic||
|Weighted average shares outstanding; basic||33,848||33,710||33,803||33,501|
|Net (loss) income per share; diluted||
|Weighted average shares outstanding; diluted||33,848||33,710||33,803||33,664|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||
|Auction rate securities||3,240||3,332|
|Fixed assets, net||3,650||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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