Progenics Pharmaceuticals Announces Third Quarter 2014 Financial Results
The Company also announced that following interactions with the
Net income for the quarter was
Progenics ended the quarter with cash, cash equivalents and securities of
"Recent months have brought extraordinary progress for RELISTOR, first with the
Third quarter revenue totaled
Current year nine months revenues were
|Net Relistor Sales|
|Three Months Ended||Nine Months Ended|
Third quarter research and development expenses decreased by
Other Recent Events
Positive long-term follow-up data from the pivotal Phase 2 trial of AZEDRA™ (Ultratrace® Iobenguane I 131) Injection was presented at the International Symposium of Pheochromocytoma and Paraganglioma held in
Kyoto, Japanin September. This trial is planned to be restarted in the first quarter of 2015.
Complete results from a Phase 2 Study of MIP-1404 were presented at the 27th Annual
European Association of Nuclear Medicine (EANM) Congressheld in Gothenburg, Swedenin October, in which MIP-1404 showed higher sensitivity as compared to MRI in detecting primary and metastatic prostate cancer.
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 income (loss) per share)|
|For the Three Months Ended||For the Nine Months Ended|
|Research and development||6,728||7,905||21,495||26,205|
|License fees - research and development||10||91||280||314|
|General and administrative||3,895||3,131||11,156||11,350|
|Depreciation and amortization||142||179||419||774|
|Intangible impairment charges||576||--||576||--|
|Change in contingent consideration liability||500||--||1,400||--|
|Other operating income||7,250||--||7,250||--|
|Operating income (loss)||36,736||(10,512)||16,324||(34,057)|
|Total other income||12||12||37||36|
|Net income (loss) before income tax benefit||36,748||(10,500)||16,361||(34,021)|
|Income tax benefit||227||--||228||--|
|Net income (loss)||
|Net income (loss) per share; basic||
|Weighted average shares outstanding; basic||69,556||60,599||67,712||54,104|
|Net income (loss) per share; diluted||
|Weighted average shares outstanding; diluted||72,879||60,599||67,727||54,104|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||
|Accounts receivable, net||41,667||2,879|
|Auction rate securities||2,208||2,208|
|Fixed assets, net||2,321||2,413|
|Intangible assets, net and goodwill||38,502||39,081|
|Contingent consideration liability||17,100||15,700|
|Deferred tax and other liabilities||13,005||13,235|
|Total liabilities and stockholders' equity||
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
About Opioids, Constipation and RELISTOR (methylnaltrexone bromide)
Opioid analgesics are frequently prescribed for patients with chronic pain, including patients with advanced illness. An estimated 27 million patients in the US are on opioids for chronic pain. Constipation is one of the most common and distressing side effects in patients receiving chronic opioid therapy. Approximately 40% of chronic pain patients, or nearly 11 million patients, on opioid therapy will experience OIC. RELISTOR is the first approved medication that specifically targets the underlying cause of OIC.
RELISTOR is a Peripherally Acting Mu Opioid Receptor Antagonist (PAMORA) specifically designed to block the constipating effects of opioids in the gastrointestinal tract. The unique molecular structure of RELISTOR restricts it from crossing the blood brain barrier and interfering with the analgesic effect of opioids. In clinical trials, approximately 50% of patients with advanced illness experienced relief of OIC in as little as 4 hours. In a study of patients with OIC and non-cancer pain, a significantly greater portion of patients taking RELISTOR 12mg daily reported having three or more spontaneous bowel movements (SBM) per week during the four week double blind period compared to placebo (59% vs. 38%). Following the first dose, 33% of patients in the RELISTOR 12 mg once daily treatment group had a SBM within 4 hours and approximately half of patients had a SBM prior to the second dose of RELISTOR. RELISTOR is the only PAMORA currently available for the treatment of OIC in patients with advanced illness receiving palliative care when the response to laxatives has been insufficient and for the treatment of OIC in patients taking opioids for chronic non-cancer pain.
RELISTOR Subcutaneous Injection was approved in
For more information about RELISTOR, please visit www.RELISTOR.com
Important Safety Information about RELISTOR
RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and at increased risk of recurrent obstruction.
Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom. Discontinue if severe or persistent diarrhea occurs during treatment.
If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia. Take into account the overall risk-benefit profile when using RELISTOR in such patients. Monitor for adequacy of analgesia and symptoms of opioid withdrawal in such patients.
The most common adverse reactions (≥ 1%) in adult patients with opioid-induced constipation and chronic non-cancer pain are abdominal pain, nausea, diarrhea, hyperhidrosis, hot flush, tremor, and chills.
The most common adverse reactions (≥ 5%) in adult patients with opioid-induced constipation and advanced illness are abdominal pain, flatulence, nausea, dizziness, and diarrhea.
Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
There are no adequate and well-controlled studies with RELISTOR in pregnant women. The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier. RELISTOR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether RELISTOR is present in human milk. However, methylnaltrexone bromide is present in rat milk. Because of the potential for serious adverse reactions, including opioid withdrawal, in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness of RELISTOR have not been established in pediatric patients.
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. Please follow us on LinkedIn®.
Information on or accessed through our website or social media sites is not included in the company's
For more information about Relistor, please visit www.relistor.com.
Melissa DownsInvestor Relations (914) 789-2801 firstname.lastname@example.org
News Provided by Acquire Media