Avadel Pharmaceuticals plc

Greetings and welcome to Avidel Pharmaceuticals' second quarter 2021 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Courtney Tariano. Thank you. You may begin.

Good morning, and thank you for joining us on our conference call. This morning, we issued our press release providing a corporate update and financial results for the quarter ended June 30th, 2021. The release can be accessed on our website, www.avadel.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 the Form 10-K for the year ended December 31, 2020, which was filed on March 9, 2021, and subsequent SEC filings. Except as required by law, Abadel 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 today are Greg Divis, Chief Executive Officer, Tom McHugh, Chief Financial Officer, and Richard Kim, Chief Commercial Officer. Dr. Jennifer Goodman, our VP of Medical and Clinical Affairs will additionally join us for Q&A following the call. At this time, I'll turn the call over to Greg.

Thank you, Courtney. Good morning, everyone, and thank you for joining us on our second quarter 2021 conference call. I will begin by providing an update on our business, highlighting the significant progress we continue to make towards the potential approval and commercialization of FP218, our once-at-bedtime treatment for managing the symptoms of narcolepsy. I will then turn the call over to Richard, who will provide an update on our commercialization and launch planning as we move closer to our October 15th PDUFA date. Lastly, Tom will review the financial results for the quarter, and we will conclude with a Q&A session where we will be joined by Jennifer. This has been an important quarter of progress for Avidel, particularly as we enter the final stages of NDA review and look toward our assigned PDUFA date of October 15th. If approved, FT218 will be the first and only once-at-bedtime option for managing excessive daytime sleepiness, or EDS, and cataplexy in adults suffering from narcolepsy. We are excited that we are only just two months away from October 15th, and I am incredibly pleased to report we remain on track across all of our business priorities, all aspects of our NDA progress, legal and regulatory planning and execution, organizational and capabilities expansion, and, of course, our launch preparation and readiness continue to advance to support the future potential commercialization of FT218. As a company and a team, we have consistently delivered against our key business objectives for the last 30-plus months to ensure we would be exactly where we are today. 60-plus days until our PDUFA date, and we are excited for what the next two-plus months and beyond have in store for Avidel, for patients living with narcolepsy, and for our shareholders as we continue to advance our vision of bringing once-at-bedtime FT218 to the market. This, of course, starts with our FT218 NDA and related regulatory filing strategy. As we have stated before, we have developed and strategically executed our FT-218 regulatory filing such to effectively navigate any potential barriers or regulatory issues related to this 505 filing. To date, and to be clear, we have not been asked by the agency to certify paragraph four against any Orange Book listed patents, and we don't believe, based on the data we have generated, and the regulatory filing strategy we have deployed with our NDA submission, there is any basis to request such a certification. Said differently, as we have stated previously, on this matter specifically, no news is indeed good news, and I am pleased to share we have nothing new to report. To date, our exchanges with the FDA continue to advance forward and are pleased with the progress and how the review has gone to date. Based on this, we remain confident in our regulatory filing strategy. In parallel, in anticipation of a potential FDA approval, we are diligently preparing to bring FT-218 to market, and we remain on track with launch and commercialization plans. We continue to be energized by the feedback and insights we are gathering on the importance of FT-218 as a potential treatment option for people living with narcolepsy. As such, we remain confident in the market potential for FT-218 if approved, and based upon our extensive research, the opportunity for FT218 to command a meaningful share of the narcolepsy treatment market. On the clinical front, during Q2, we announced new data from the pivotal Phase III Reston trial at Sleep 2021, all of which continues to support the clinical benefit of FT218 at all doses evaluated. As a reminder, we have previously shared the overwhelmingly positive top-line data from the pivotal Phase III Reston trial, which demonstrated the unequivocal, statistically significant, and clinically meaningful benefit of FT218. FT218 met all three co-primary efficacy endpoints compared to placebo for all three doses evaluated, was generally well-tolerated, and delivered clinical benefit as early as week three of treatment. The strength of these positive co-primary results are further bolstered by additional secondary endpoints as well as post hoc analysis presented at sleep 2021, showing a consistent positive effect of FT218, regardless of whether participants had narcolepsy type 1 or type 2, or if they were receiving a stable dose of stimulants or not. Additionally, patients' dose with FT218 experienced a significantly greater decrease in weight and body mass index from baseline to study end compared to placebo. These additional data strengthen the body of evidence that, if approved, FT218 has the potential to be a transformative treatment option. As we proceed to the remainder of 2021, we expect our pivotal Phase III data to be published in a leading peer-reviewed journal and expect additional FT218 clinical data to be presented at future scientific meetings in 2021 and 2022. To sum up, I'm extremely proud of the tremendous progress we have made as we seek to establish our investigational once-at-bedtime FT218 as a treatment of choice for healthcare practitioners treating and for patients living with narcolepsy. All plans to date remain on track, including our regulatory filing strategy, and we look forward to the next 60-plus days as we head toward the October 15th PDUFA date in our pursuit of FDA approval and a potential commercial launch. With that, I will turn the call over to Richard. Richard?