Avadel Pharmaceuticals plc

The Avondale Pharmaceuticals fourth quarter and full year 2020 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I'll now turn the conference over to your host, Tom McHugh. You may begin.

Good morning, and thank you for joining us on our conference call. This morning, we shoot our full year and fourth quarter financial results news release. The release can be accessed on our website, www.avidel.com. As a reminder, before we begin, the following presentation includes several 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 in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market entry and acceptance of products, and the impact of competitive products and pricing. These and other risks are described more fully in AVIDEL's public filings under the Exchange Act, included in Form 10-K for the year ended December 31, 2019, which was filed on March 16, 2020, and subsequent SEC filings. Except as required by law, Abidell undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events, or otherwise. On the call with me today are Greg Divis, our Chief Executive Officer, Richard Kim, our Chief Commercial Officer, and Dr. Jennifer Goodeman, our VP of Medical and Clinical Affairs. At this time, I'll turn the call over to Greg.

Thank you, Tom. Good morning, everyone, and thank you for joining us on our fourth quarter 2020 conference call. I will begin with several updates on our business outlook, highlighting the significant progress made and key milestones achieved over the past several months. Jennifer will then offer an overview of the progress we've made with our scientific communications for FT218, including the upcoming presentation of secondary and post hoc data from Reston, which we are all excited for as it builds upon the primary endpoint data presented last year. Richard, who just recently joined as our Chief Commercial Officer, will provide his early views on where we are from a launch readiness perspective, including his initial insights into our commercialization and launch planning for FT218 and his near-term priorities as we move closer to the PDUFA date and a potential FDA approval. Finally, Tom will provide a review of the financial results for the quarter, and we will conclude with a Q&A session. With that as an outline for the call, let's get started. Overall, I am very proud of and pleased with the progress we have made over the last 12 months. We continue the transformation of Avidel while successfully executing the clinical development and the regulatory filing strategy for our lead program, FT218, an extended release, a once-nightly formulation of sodium oxibate, for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy. It was just a year ago that we were completing our pivotal phase three rest on study of ST218, just prior to the pandemic taking hold. Since then, and despite the COVID-19 challenges we have all faced, we announced in late April the positive top line results from the rest on study, including that ST218 met all three co-primary efficacy endpoints at all three doses, demonstrating highly significant clinically meaningful improvements compared to placebo, and was well tolerated with low rates of commonly known sodium-oxibate adverse reactions. We completed the additional work for and preparation of the NDA filing for FT218, including a successful pre-NDA meeting in Q3 that was followed up with the full NDA submission to the FDA in December. and just last week announced that the FDA notified us in a day 74 letter that the NDA for FT218 was accepted and assigned a PDUFA target action date of October 15, 2021. We are pleased with the overall response and the limited comments that the agency has provided to date. The acceptance of the submission supports our confidence in our NDA and overall regulatory filing strategy. In addition, Through this stage of the review, we have not been asked to provide a paragraph four certification against any orange book listed patents. Furthermore, based on the proposed label and data package we've submitted as part of the NDA for FD218, we have no reason to believe we should be asked to do so. As we advance and execute our business plan and priorities, the same success brief success is beginning to ring true for Avidel. The full promise of FT218's profile is now coming into view as we deliver the positive rest on data. Confirm the significant commercial opportunity with our market insights, including the clear patient and physician preference for once nightly FT218. And now on the heels of FDA acceptance of our NDA, with our strong conviction and our regulatory filing strategy, we are positioned to deliver on our mission of liberating patients with narcolepsy from middle-of-the-night dosing and creating significant and deserved value for our shareholders. The momentum we are experiencing in the market is real and it is profound, from key opinion leaders to patient groups to our newest team members. The growing level of interest in once-nightly FT218 and Avidel is rapidly accelerating and is attracting the best of the best as we prepare to disrupt this 18-year-old multi-billion dollar market to the potential benefits of patients, healthcare providers, and our shareholders. With that setting of the stage, let's get into a little bit more detail on some of these highlights. To begin, I'm pleased to turn the call over to Dr. Jennifer Goodeman, who joined our team at the end of last year and is overseeing all medical and clinical affairs activities and is already making a tremendous impact. Jennifer, the floor is yours.