Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q1 2019 Earnings Conference Call Transcript

May 08, 2019 • 08:30 am ET


Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q1 2019 Earnings Conference Call Transcript


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Good morning, ladies and gentlemen, thank you for standing by. And welcome to the Avadel Pharmaceuticals' First Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. (Operator Instructions)

I will now turn the call over to Mr. Mike Kanan, Chief Financial Officer of Avadel. You may now begin.

Michael F. Kanan

Good morning, and thank you for joining us on our conference call. This morning, we issued our first quarter 2019 financial results news release. The release can be accessed on our website at www.avadel.com. As a reminder, before we begin, the following presentation includes a number of matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements.

These risks include risks that products and the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products and the impact of competitive products and pricing. These and other risks are described more fully in Avadel's public filings under the Exchange Act, including the Form 10-K for the year ended December 31, 2018, which was filed on March 15, 2019.

Except as required by law, Avadel undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise. After the prepared remarks, we will be opening the call for Q&A. On the call with me today are Greg Divis, our Interim Chief Executive Officer; Dr. Jordon Dubow, our new Chief Medical Officer; and Geoff Glass, Chairman of our Board of Directors.

At this time, I will turn the call over to Greg Divis, Greg?

Gregory J. Divis

Thank you, Mike and good morning, everyone, and thank you for joining us on our call this morning. As most of you are aware this past quarter Avadel initiated a major restructuring of the company to preserve our financial health and strengthen our operational focus by directing the majority of our resources toward the successful development of FT218, our novel once nightly formulation of sodium oxybate for the treatment of narcolepsy. To accomplish this, we have taken a series of urgent and critical actions with the overall objective of not only strengthening our financial health, but also providing clarity and focus to our strategy. And thus positioning the company for potential longer term sustainable growth and value creation. These actions include, one, stopping the substantial cash burn by rapidly ceasing spend on Noctiva. Two, conducting a comprehensive independent assessment of the FT218 program to identify opportunities to strengthen our position in the market, the clinical development timing and the probability of success. Three, increasing our transparency with investors on the status and progress of FT218. Four, enhancing our internal clinical and medical expertise deployed and dedicated to FT218. And five, maximizing the cash flow and profitability of our declining hospital business. I'm pleased to communicate