Avadel Pharmaceuticals plc

Greetings and welcome to the Avidale Pharmaceuticals Third Quarter 2023 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 Austin Murthoff with Stern Investor Relations. You may begin.

Good morning, and thank you for joining us on our conference call to discuss Avidel's third quarter 2023 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 risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks and uncertainties are described in AVIDEL's public filings under the Exchange Act included in the Form 10-K for the year ended December 31, 2022, which was filed on March 29, 2023, 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 Givis, Chief Executive Officer, Richard Kim, Chief Commercial Officer, and Tom McHugh, Chief Financial Officer. Dr. Jennifer Goodman, Senior Vice President of Medical and Clinical Affairs, will join us for Q&A. At this time, I'll turn the call over to Greg.

Thank you, Austin. Good morning, everyone. And thank you for joining us to review Avidel's third quarter 2023 results. We're excited to share the progress we have made with the launch of LUMRA. Following my opening remarks, Richard will provide an update on our launch progress, Tom will provide a review of our Q3 financial results, and we will conclude with a question and answer session. The third quarter was transformational for Avidel, as we fully transitioned to a commercial stage company and are very pleased with the robust early demand generated and important emerging launch trends we are seeing. There is a tremendous opportunity for Loonrise and Avidel that lies ahead as we execute our launch. We believe the foundation we are building during these early months positions us incredibly well for continued success building on the momentum built during this first full quarter of launch. During Q3, this momentum resulted in growth across all key launch metrics, representing strong demand across all three patient segments of the eligible narcolepsy patient population, and generated $7 million in Lunarize net revenue. There's no better evidence of this than the early launch KPIs we announced this morning. Greater than 1,000 patients enrolled in Rise Up and more than 400 patients who initiated therapy during the quarter, the majority of which are fully reimbursed. Expanded luminized payer coverage with key health plans representing approximately 60% of all commercial lives, and this progress on the payer front continues to create even greater access for the 600 patients enrolled in our Rise Up patient services program and in process of obtaining coverage and getting on Lumerize as of September 30th. Additionally, there are nearly 1,400 healthcare providers who have now completed the Lumerize REM certification process, including providers who have never previously prescribed inoxibate. We're very encouraged by these early KPIs and believe they are indicators of the strong interest and positive engagement we have had with all stakeholders as we've advanced the launch of Lumer. Furthermore, to support the robust clinical data of Loonrise, our team recently attended World Sleep in Rio de Janeiro, Brazil, where we shared 15 poster presentations and two oral presentations detailing new and encore data, further demonstrating the clinical profile and clear benefit of Loonrise for potential eligible patients. Looking forward to the future, Our team is also advancing our lifecycle management opportunities as we believe this has the potential to expand the patient population who could benefit from LumeRise and provide long-term value to the company and our stakeholders. We are pleased to announce that yesterday we submitted a supplemental new drug application to the FDA for LumeRise in the pediatric narcolepsy population for the treatment of cataplexy or EDS. and currently expect an approval decision in the second half of 2024. Comprising approximately 4% to 5% of the current total activated treated narcolepsy population, expanding availability into the pediatric population not only increases the total addressable market for luminescence, but also has the potential to greatly alleviate the burden on families and caregivers who support children living with narcolepsy. We believe these families and caregivers will welcome a once-at-bedtime oxibate treatment option, as the twice-nightly dosing regimen of first-generation oxibates inevitably requires potentially multiple people in the household to chronically wake up night after night to administer the second dose for their children. Additionally, we're making progress with our clinical planning to initiate a multi-center randomized controlled trial for idiopathic hypersomnia, or IH. And we believe, based upon our interactions with key opinion leaders, that the value proposition of once-at-bedtime lumerize could be very compelling for those suffering from the deep sleep inertia associated with IH. And lastly, on the life cycle management front, we are continuing our preclinical development of our potential no or low-sodium once-at-bedtime oxibate formulation for the small subset of sodium-sensitive oxibate-eligible patients. As always, we intend to provide updates on these programs as appropriate. With a strong balance sheet to support ongoing operations and the significant progress achieved in the initial month of the launch, we remain hyper-focused on the Lumerise launch and expanding our reach and our impact. We are committed to and remain relentless in delivering on the promise of Lumerise for all stakeholders. And with this positive momentum coming out of Q3, we believe we are on track to command a meaningful share of the multi-billion dollar activate market and maintain our view that Lumerize is a greater than $1 billion annual revenue opportunity. With that, I'll turn the call over to Richard for details on our recent commercial progress. Richard.