Avadel Pharmaceuticals plc

Greetings and welcome to Avidel Pharmaceutical's second quarter 2022 earnings call. At this time, all participants are in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, then two. It is now my pleasure to introduce Brandy Robinson. Thank you. You may begin.

Good morning, and thank you for joining us on our conference call to discuss second quarter 2022 earnings. 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 risk 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 31st, 2021, which was filed on March 16, 2022, in 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 Divitz, Chief Executive Officer, Dr. Jennifer Goodman, Vice President and Medical and Chief, excuse me, Vice President of Medical and Clinical Affairs Richard Kim, Chief Commercial Officer, and Tom McHugh, Chief Financial Officer. At this time, I'll turn the call over to Greg.

Good morning, everyone, and thank you for joining us to discuss our second quarter 2022 results. This was an important quarter for Avidel where we continued to make progress in our mission to bring LumeRise to all once-at-bedtime eligible patients living with narcolepsy. which included the receipt of a notable and important regulatory milestone for LUMRISE in the form of a tentative approval, the active pursuit of additional legal and regulatory strategies to accelerate a final FDA decision for LUMRISE prior to June of 2023, or when the REMS patent we certified on will expire, and the continued execution of our commercial preparations with a focus on shortening the time between final approval and launch while we took the necessary actions to ensure, as required, we have the liquidity to carry us to the potential outer date of a final FDA approval decision. With that, I will start by commenting on our most recent company update. On July 19th, we announced that the FDA granted tentative approval of Lumerize, formerly known as FT218, our investigational once-at-bedtime oxibate therapy for the treatment of cataplexy or excessive daytime sleepiness in people with narcolepsy. Receiving tentative approval is an important step toward a final approval. By granting tentative approval, the FDA has validated the clinical and safety profile of LumeRise and confirms that LumeRise is approvable as a once-at-bedtime therapy for eligible patients living with narcolepsy, which we believe is a meaningful, de-risking regulatory event for the company. LumeRise has a demonstrably strong clinical profile with an improved dosing regimen and that per our extensive research, is preferred by patients and sleep specialists. This, along with our comprehensive launch strategy, gives us the confidence in the potential significant role Lumerize can play in the $3 billion-plus market opportunity. Further, and perhaps most importantly, receiving tentative approval confirms that the potential latest date we could receive a final approval decision for Lumerize is after expiry of the REMS patents. which is June 17, 2023, or just 10 months and eight days from today. As previously stated, we are and will continue to aggressively pursue legal and regulatory strategies with the clear objective of potentially leading to a final approval decision prior to June 2023, and depending on timing and results of these legal actions, possibly by the end of this year. In this regard, we filed a motion in the U.S. District Court for the District of Delaware to delist the REMS patent from the FDA's Orange Book on June 23rd, as we do not believe the substance of the REMS patent qualifies as an eligible Orange Book listable patent. A court order requiring the patent holder to delist the REMS patent from the Orange Book could provide a pathway for a final approval of Lumerize prior to June 2023. As the court previously stated that a claim construction hearing is required before ruling on the motion to delist. The next step in this process is the Markman or claim construction hearing, which is scheduled for August 31st. Additionally, we recently announced that we filed an administrative procedure act lawsuit against FDA alleging that their decision requiring us to file a patent certification on the rents patent was arbitrary, capricious, and contrary to applicable law. In this lawsuit, we are asking the court to vacate the FDA's patent certification decision and order FDA to take final action on the Lumerise NDA within 14 days after vacating their decision. A successful outcome in this APA suit could also lead to a potential final approval of Lumerise prior to June of 2023. An accelerated briefing schedule order has been approved by the court, and we currently expect this case to be heard at the end of September 2022. In addition to these opportunities to accelerate a potential final approval, we are also focusing on launch preparation activities that will shorten the time to launch following final approval. This includes completion of manufacturing and primary packaging for our commercial supply, in operationalizing our REMS program, both in advance of a final approval and before the end of this calendar year. In summary, we are well-positioned to execute on all of these priorities to potentially accelerate bringing LoomRISE to a final approval prior to June 2023 and subsequent launch as soon as possible thereafter. As you will hear next, Jennifer will provide details on the data we presented this quarter at SLEEP 2022. And following Richard, we'll give an update on our launch readiness actions now with the tentative approval in hand. With that, I'll turn the call over to Jennifer.