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Progenics Pharmaceuticals : Announces Second Quarter 2019 Financial Results and Business Update

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08/12/2019 | 09:53am EDT

NEW YORK - Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced financial results for the second quarter 2019 and provided a business update.

'We are excited to report significant progress across our entire portfolio, with commercial, clinical, and business development achievements forming a strong foundation for near-term growth,' said Mark Baker, Chief Executive Officer of Progenics. 'AZEDRA commercial dosing is underway and we are now focused on converting our growing number of treatment requests into treated patients. We are on our way to unlocking the significant value of this drug for both patients and our shareholders.'

Mr. Baker continued, 'We also continued to drive the development of our PSMA-targeted prostate cancer pipeline of diagnostics and therapeutics. Strong interest in our PyL imaging agent resulted in rapid enrollment in our Phase 3 CONDOR study, and we are now looking ahead to a topline data readout by year end. We commenced dosing in our Phase 2 trial of 1095 and, assuming early positive data from this open-label trial, see potential to advance 1095 into a pivotal trial in 2020 following agreement from the FDA. Our recent partnerships with ROTOP and FUJIFILM, together with our established partnerships with Bayer and Curium, provide additional validation for our PSMA-targeted approach and expand the reach of our pipeline across the globe. As we continue to grow our pipeline and operations, we remain focused on delivering our life-saving treatments for cancer to the patients who need them while creating significant value for our shareholders.'

Second Quarter and Recent Key Business Highlights

AZEDRA (iobenguane I 131) 555 MBq/mL injection for intravenous use, Ultra-orphan Radiotherapeutic

U.S. Launch of AZEDRA Advances with First Patients Dosed

AZEDRA is the first and only approved therapy in the U.S. for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. In June 2019, the Company recorded its first commercial sales and completed the first administrations of commercial AZEDRA. As of today, there are 13 multidisciplinary treatment centers across the U.S. activated for patient treatment. We have 32 treatment requests. Our commercial focus is on converting these requests to treated patients.

CMS Grants New Technology Add-On Payment for Inpatient Use of AZEDRA

Last week, Centers for Medicare & Medicaid Services (CMS) approved a new technology add-on payment (NTAP) for AZEDRA when administered in the hospital inpatient setting for Medicare beneficiaries in FY2020. The NTAP will cover the lesser of 65 percent of the average cost of AZEDRA, or 65 percent of the costs in excess of the Medicare Severity Diagnosis Related Groups (MS-DRG) payment for the case. As a result, the maximum NTAP for a case involving a therapeutic dose of AZEDRA is $98,150.

Initiation of Basket Trial by Year End to Support Expanded Label

The Company reached alignment with the U.S. Food and Drug Administration (FDA) on a clinical development plan to potentially support an expanded label for AZEDRA for the treatment of patients with advanced neuroendocrine tumors (NETs) who have MIBG-avid tumors. Progenics plans to conduct a tissue agnostic, basket study that will evaluate AZEDRA in patients with NETs that are MIBG-avid, including gastroenteropancreatic neuroendocrine tumors, as well as other NETs, and utilize a dosing regimen that enables outpatient administration. The basket study is expected to begin by the end of the year and enroll approximately 150 patients at sites in the U.S and Canada.

Updated Survival Data Presented at ASCO

Long-term follow up data from the pivotal Phase 2 study of AZEDRA were presented at the 2019 American Society of Clinical Oncology (ASCO) 2019 Annual Meeting. Notably, data showed a five-year long-term survival rate of 38.3% and a median survival time for all patients of 41.1 months (95% CI 31.1, 91.2).

PSMA-Targeted Prostate Cancer Pipeline

Enrollment Completed Ahead of Schedule in Phase 3 Trial of PyL (18F-DCFPyL); Topline Data Expected by Year End 2019

Patient enrollment for the Phase 3 CONDOR trial, evaluating the diagnostic performance and clinical impact of PyL was completed five months ahead of schedule. The Phase 3 CONDOR trial is a multi-center, open label trial that enrolled 208 male patients with biochemical recurrence of prostate cancer at 14 sites in the U.S. and Canada. Based on discussions with the FDA, Progenics believes that positive data from the CONDOR study and the previously reported OSPREY study could serve as the basis for a New Drug Application for PyL.

Multiple Data Presentations at SNMMI 2019 Annual Meeting Highlight Potential of PyL

Data from the Company's Phase 2/3 OSPREY trial of PyL in men with high risk and metastatic prostate cancer and three investigator-sponsored studies conducted under the Company's PyL Research Access Program that evaluated PyL in men with biochemically recurrent prostate cancer were presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2019 Annual Meeting. The data presented highlighted the high diagnostic potential of PyL to detect high risk primary prostate cancer, biochemically recurrent prostate cancer, and metastatic disease, as well as importantly alter physician treatment decision-making.

Initiation of Patient Dosing in Phase 2 Trial of 1095

The Company announced that the first patient was dosed in the ongoing Phase 2 trial of 1095 in combination with enzalutamide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (mCRPC). 1095 is a small molecule radiotherapeutic designed to selectively bind to the extracellular domain of prostate specific membrane antigen (PSMA), a protein that is highly expressed on prostate cancer cells. Based on the early data emerging from this open-label trial and dialogue with the FDA, the Company plans to evaluate initiating a pivotal trial of 1095 in 2020.

Partner Bayer Initiates Phase 1 Trial of PSMA TTC, Triggering $2.0 Million Milestone Payment

Bayer dosed the first patient in its Phase 1 trial of PSMA TTC, a PSMA-targeted monoclonal antibody thorium conjugate in the development for the treatment of metastatic castration resistant prostate cancer. Under the terms of the companies' 2016 collaboration, the achievement of this clinical milestone triggered a $2.0 million payment to Progenics.

Progenics Pharmaceuticals Provides Update on PSMA-617 Intellectual Property Ownership Assertion

On August 6, the District Court of Mannheim in Germany held the first oral hearing in the case. The Court considered procedural matters and granted the parties the right to make further submissions.

European Collaboration with ROTOP for 1404

The Company entered into an exclusive license agreement with ROTOP Pharmaka GmbH (ROTOP), a leading radiopharmaceuticals company focused on diagnostics and therapeutics, to develop and commercialize 1404 in Europe. Under the terms of the collaboration, ROTOP will be responsible for the development, regulatory approvals, and commercialization of 1404 in Europe, while Progenics is entitled to double-digit, tiered royalties on net sales in the territory. ROTOP plans to request a meeting with European regulators to discuss a clinical development plan for 1404 and start a clinical trial in early 2020.

Digital Technology

FDA 510(k) Clearance Granted for Cloud-Based Version of Automated Bone Scan Index (aBSI)

The aBSI automatically segments the anatomical regions of the skeleton and detects and classifies lesions in the bone scan of prostate cancer patients. The aBSI has been shown to be an objective measure of the quantitative change in disease burden and is a prognostic biomarker in patients with metastatic prostate cancer. Earlier this week, the Company received 510(k) clearance from the FDA to market its cloud-based version of aBSI product in the U.S. This clearance of our cloud-based software as a medical device is an essential step towards the further development of PSMA AI.

Validating PSMA AI Data Presented at SNMMI

The Company presented results from its PSMA AI technology at the SNMMI 2019 Annual Meeting during an oral session. The prospective study evaluated the diagnostic performance of PSMA AI using SPECT/CT scans from the Company's Phase 3 study of 1404. Independent readers using Progenics' PSMA AI demonstrated a statistically significant improvement of accuracy, speed, and reproducibility over readers without PSMA AI.

Collaboration with VA on Progenics' AI Research Plan

Progenics initiated a collaboration that provides the VA Greater Los Angeles Healthcare System (VAGLAHS) with access to the Company's AI platform for investigational use. In the project, the VAGLAHS network will gain access to Progenics' machine learning platforms, which includes the aBSI and the PSMA AI platforms. The collaboration will explore novel predictive machine learning algorithms from the digital medical images and associated clinical outcomes. These novel algorithms will be prospectively validated at VAGLAHS for effective healthcare management of veterans with prostate cancer. This project is the nation's first collaborative effort to validate cutting-edge machine learning tools for improving treatment management of veterans with prostate cancer and provides additional validation to Progenics' AI platform.

FUJIFILM Toyama Chemical Co. Acquires Japanese Rights to aBSI

Progenics entered into a transfer agreement with FUJIFILM Toyama Chemical Co, Ltd. (FUJIFILM) for the rights to the Company's aBSI product in Japan for use under the name BONENAVI. Under the terms of the agreement, FUJIFILM acquired, by a combination of purchase and license, the Japanese software, source code, supporting data, and all Japanese patents associated with the aBSI product from Progenics for use in Japan. In exchange, Progenics received $4.0 million in an upfront payment and will receive service fees for aBSI and other AI products over three years in Japan. BONENAVI has been licensed to FUJIFILM for use in Japan since 2011.

RELISTOR, Treatment for Opioid-Induced Constipation (partnered with Bausch Health Companies Inc.)

Second Quarter 2019 RELISTOR Net Sales of $24.0 Million

The second quarter 2019 net sales of RELISTOR, as reported by its partner Bausch Health Companies, Inc., translated to $3.6 million in royalty revenue for Progenics for the quarter.

RELISTOR Tablets Protected Until 2031 Following Federal Court Patent Decision

U.S. District Court of New Jersey upheld the validity and determined Actavis' infringement of a patent protecting RELISTOR tablets, expiring March 2031. Defendant, Actavis Laboratories FL, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd, had challenged the validity of and had alleged non-infringement of Claims 2 and 5 of U.S. Patent No. 8,524,276, which protects the formulation of RELISTOR tablets.


Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Bausch Health Companies, Inc. RELISTOR Tablets (450 mg once daily) are approved in the United States for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for OIC approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.


RELISTOR (methylnaltrexone bromide) tablets, for oral use and RELISTOR (methylnaltrexone bromide) injection, for subcutaneous use

RELISTOR tablets and injection are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

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.

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 and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.

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.

The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.

A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions.


Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer, including: therapeutic agents designed to treat cancer (AZEDRA, 1095, and PSMA TTC); prostate-specific membrane antigen ('PSMA') targeted imaging agents for prostate cancer (PyL and 1404) and imaging analysis technology (aBSI and PSMA AI). Progenics has two commercial products, AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy and RELISTOR (methylnaltrexone bromide) for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies Inc.

Forward Looking Statements

This press release contains projections and other 'forward-looking statements' regarding future events. Statements contained in this communication that refer to Progenics' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics' current perspective of existing trends and information as of the date of this communication and include statements regarding Progenics' strategic and operational plans and delivering value for shareholders. Forward looking statements generally will be accompanied by words such as 'anticipate,' 'believe,' 'plan,' 'could,' 'should,' 'estimate,' 'expect,' 'forecast,' 'outlook,' 'guidance,' 'intend,' 'may,' 'might,' 'will,' 'possible,' 'potential,' 'predict,' 'project,' or other similar words, phrases or expressions. 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: market acceptance for approved products; the risk that the commercial launch of AZEDRA may not meet revenue and income expectations; the cost, timing and unpredictability of results of clinical trials and other development activities and collaborations; the unpredictability of the duration and results of regulatory review of New Drug Applications (NDA) and Investigational NDAs; the inherent uncertainty of outcomes in the intellectual property disputes such as the dispute with the University of Heidelberg regarding PSMA-617; our ability to successfully develop and commercialize products that incorporate licensed intellectual property; the effectiveness of the efforts of our partners to market and sell products on which we collaborate and the royalty revenue generated thereby; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; possible product safety or efficacy concerns, general business, financial, regulatory and accounting matters, litigation and other risks ; the costs and management distraction attendant to activist shareholder campaigns and risks related to changes in the composition of our Board of Directors following our 2019 Annual Meeting of Shareholders. 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 Securities and Exchange Commission (the 'SEC'), including those risk factors included in its Annual Report on Form 10-K for the year ended December 31, 2018, as updated in its subsequent Quarterly Reports on Form 10-Q. Progenics is providing the information in this press release as of its date and, except as expressly required by law, Progenics disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.


Melissa Downs

Tel: (646) 975-2533

Email: mdowns@progenics.com

(C) 2019 Electronic News Publishing, source ENP Newswire

Stocks mentioned in the article
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FUJIFILM HOLDINGS CORP -0.57% 4566 End-of-day quote.8.30%
PROGENICS PHARMACEUTICALS, INC. 10.10% 4.33 Delayed Quote.-8.10%
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Financials (USD)
Sales 2019 33,8 M
EBIT 2019 -76,6 M
Net income 2019 -83,2 M
Finance 2019 9,00 M
Yield 2019 -
P/E ratio 2019 -3,89x
P/E ratio 2020 -9,97x
EV / Sales2019 9,61x
EV / Sales2020 4,61x
Capitalization 334 M
Duration : Period :
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Mean consensus BUY
Number of Analysts 5
Average target price 9,10  $
Last Close Price 3,86  $
Spread / Highest target 263%
Spread / Average Target 136%
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Mark Robert Baker Chief Executive Officer & Director
Peter J. Crowley Chairman
Patrick Fabbio CFO, Principal Accounting Officer & Senior VP
Syed Mahmood Vice President-Medical Affairs
Asha Das Chief Medical Officer
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