Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) Q4 2017 Earnings Conference Call - Preliminary Transcript

Mar 08, 2018 • 08:30 am ET


Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) Q4 2017 Earnings Conference Call - Preliminary Transcript


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Good day ladies and gentlemen and welcome to the Progenics Fourth Quarter and Year End 2017 Earnings Conference Call. At this time all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to hand the floor over to Melissa Downs, Senior Manager of Investor Relations. Please go ahead.

Melissa Downs

Thank you, Karen. On behalf of Progenics management team, thank you for joining our conference call to review our fourth quarter and full year 2017 financial results and provide a business update.Joining the call today are Mark Baker, Chief Executive Officer; and Pat Fabbio, Senior Vice President and Chief Financial Officer. Before we begin, I'll remind you that remarks made on this call that are not historical in nature may be forward-looking statements and are subject to a number of risks and uncertainties. Our actual results may differ materially. Such remarks may include, but are not limited to, those involving regulatory actions, clinical development, and other matters related to our prostate cancer pipeline, AZEDRA, RELISTOR, and our other product candidates; our business and commercialization strategies and expectations of future growth; revenues and assessments of our competitive position.

Please see our most recent forms 10-Q and 10-K, which we'll -- we will be filing later today and other filings with the US Securities and Exchange Commission for additional information on the risks that could cause our actual results to differ. As a reminder, statements we make today are as of March 8th, 2018, only.

I will now turn the call over to Chief Executive Officer, Mark Baker. Mark?

Mark Baker

Thank you, Melissa and good morning to everybody joining us today. 2017 was a year of strong progress for Progenics' targeted oncology pipeline programs capped by the FDA's acceptance for review of our new drug application for AZEDRA at the end of December. This represents some major milestone for our growing company and the AZEDRA program.

We are working to prepare for a launch, following a potential approval as we approach the FDA's PDUFA action date, which is April 30th. AZEDRA has the potential to be a breakthrough treatment option for patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, or pheo and para, which are rare and life-threatening neuroendocrine tumors, for which there are no approved therapies in the United States.

Pheo and para tumors produce catecholamines, which can damage the cardiovascular system and other organ systems. Therefore, morbidity among patients is driven not only by tumor burden, but also by the harm these hormones cause to their surrounding environment. AZEDRA is designed to deliver highly targeted therapy directly to the site of these tumors, while also minimizing the acute cardiovascular symptoms associated with them.

Our innovative, rationally designed treatment has demonstrated efficacy in addressing the multiple challenges associated with these cancers. Our NDA is supported by positive data from our pivotal Phase 2b open-label multicenter trial conducted under a