Avadel Pharmaceuticals plc

Greetings and welcome to the Avidel Pharmaceuticals Third 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 Turiano. 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 September 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, Avidel 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, and Tom McHugh, Chief Financial Officer. Dr. Jennifer Goodman, our VP of Medical and Clinical Affairs, and Richard Kim, Chief Commercial Officer, 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 third quarter 2021 conference call. I will begin by providing an update on our business, highlighting the progress we continue to make towards the potential approval and commercialization of FT218. are once-at-bedtime treatment for managing cataplexy or excessive daytime sleepiness, or EDS, in adults with narcolepsy. I will then turn the call over to Tom to review the financial results for the quarter, and we will conclude with a Q&A session, where we will be joined by Richard and Jennifer. I'll start with an update on the status of our FP218 NDA, which undoubtedly is top of mind for everyone. As a reminder, in mid-October, we received notice from the FDA that the review of our NDA for FT218 was still ongoing, and they would be unable to complete the review by the previously assigned target action date of October 15th. The agency also informed us that there were no information requests at that time. Over the last three weeks, we have had interactions with the agency which have been confirmatory with what was communicated October 15th. and that the review of our NDA is ongoing and it is progressing. As an example, we have had exchanges on review matters which are consistent and ordinary course in terms of substance and topics for a company like ours in the late stages of regulatory review. Although we don't believe it is appropriate to discuss specifics, we are pleased the review has continued to progress and look forward to continuing to work with the agency throughout the remainder of our review process. Furthermore, Consistent with what we have said for the past 10 months, to date, we still have not been asked by the agency to certify paragraph 4 against any Orange Book listed patents. And we continue to believe, based on the data we have generated and our regulatory filing strategy, there is no basis to request such a certification. Additionally, in October, we filed an 8K regarding a U.S. patent application that published on October 21st. The question of a drug-drug interaction, or DDI, is a question that has often been asked over the past few years, and that published patent application clearly discloses there is no material PK drug interaction between FT218 and divalproxodine. In particular, in the disclosed studies, the systemic exposure ratios of sodium oxidate measured after administration of FT218 with and without dalvopraxodium, stayed within the 80 to 125% no-effect boundary. This is not meant to imply what will or will not be included in the label for FT218, but simply put, our PK studies indicate there is no material drug-drug interaction. We remain confident in the approvability of FT218 and look forward to continuing to work with the agency to bring this important therapy to patients as quickly as possible. We're motivated and excited by the tremendous potential of FT218, if approved, to offer a meaningful treatment option for patients living with narcolepsy, which is supported by a strong and growing body of clinical evidence. In this regard, under the leadership of Jennifer, along with her medical team, we have now published our primary manuscript in the leading peer-reviewed journal, Sleep, describing the unmet need for a single bedtime dose, and the data supporting the clinical effectiveness and tolerability of FT218. Additionally, this quarter, we presented new clinical data from our pivotal Phase III rest-on clinical trial just last month at CHEST 2021. These data presented further confirmed the potential benefits that FT218, if approved, can offer patients and continues to demonstrate that FT218 has a compelling clinical profile. Specifically, when treated with FT218, a significantly greater proportion of participants experienced 25%, 50%, and 75% reductions in the number of weekly cataplexy episodes with once-at-bedtime FT218 at all doses and at all time periods studied compared to placebo. We also presented the results of a discrete choice experiment, or a DCE. which are increasingly used in healthcare decisions, including regulatory submissions, to understand the specific attributes that drive a patient's treatment preference. For this IRB-approved study, 75 participants with narcolepsy, including 50 current twice-nightly sodium oxidate patients and 25 past users of twice-nightly sodium oxidate, were evaluated to understand the drivers of patient treatment preference for sodium oxidate. The results of this study demonstrate that dosing frequency is the single most important attribute of an OxyBait treatment, with once nightly dosing being significantly more preferred than twice nightly dosing. In addition, the DCE also asked participants to consider the likelihood of taking the medication exactly as directed and which regimen could reduce anxiety or stress associated with their OxyBait treatment. For both questions, once-nightly dosing was again identified as the most important driver of a preferred sodium oxibate treatment. These data continue to underscore the importance of once-at-bedtime dosing supported by the proven clinical efficacy of FT218 to improve both cataplexy attacks and measurements of excessive daytime sleepiness. Our vision at Avidel has always been centered around patients and to improve the treatment of their narcolepsy. and we are confident that FT218, if approved, will not only be effective, but also preferred by patients and healthcare professionals. As the review of the FT218 NDA continues, our launch preparation readiness plans also are progressing to support the commercialization of FT218. Over the past six-plus months, the progress Richard and his team have made is both significant and exceptional. They continue to build a strong team of highly experienced orphan drug launch leaders, and key operational team members who, in short order, have really accelerated our launch readiness across all critical commercial functions. As we have stated previously, the largest addition to our growing commercial team will be our field sales team, which we are prepared to complete following potential FDA approval of FT2 and 8. We also continue to advance work with our external partners to build out our distribution strategy as we are now finalizing our specialty pharmacy network following the selection of our REMS and patient services partners, respectively. We recently launched our disease education website, narcolepsydisrupts.com, and continue to build out other patient, provider, and payer engagement tools and programs to support our launch and launch readiness. On the payer front, we continue to make strong progress and are pleased with the level of engagement payers have had with our team to date. Our market access team was well represented at the PCMA annual meeting for the PBMs and their GPOs, as well as at the recent Asymbia meeting for specialty pharmacy. I personally was able to join our team at PCMA and saw firsthand the high level of interest in the potential future collaboration with us to help serve the narcolepsy patient community. Our launch strategy and preparations are supported by our ongoing market research, customer insights, and data analytics, all of which continue to demonstrate that the FT218 value proposition is clearly understood and is highly valued across patients, prescribers, and payers. We believe that once-at-bedtime FT218, if approved, has the potential to not only help patients manage their EDS and their cataplexy, but also potentially enable patients to do this while enjoying a more natural sleep-wake cycle, which includes the possibility of a desperately needed uninterrupted night's sleep that current twice-nightly OxyBait simply cannot offer. Overall, from a launch readiness perspective, we continue to make great progress and plan to provide more details of our launch plans, including our views on the market and the subsequent commercial opportunity following the potential approval of FT218. I'm extremely proud of the dedication of our team, getting us to where we are today. And we're excited about the future for Avidel, the future for our shareholders, and as importantly, the future for patients living with narcolepsy, as we continue to advance our vision of bringing once-at-bedtime FT218 to market. With that, I will turn the call over to Tom to review our financials for the quarter. Tom?