Avadel Pharmaceuticals plc

Good day, everyone, and welcome to today's Avidel Pharmaceuticals 3Q24 earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing the star and 1 on your telephone keypad. You may withdraw yourself from the queue by pressing star 2. Please note this call is being recorded, and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Austin Murtaugh with PrecisionAQ.

Good morning, and thank you for joining us on our conference call to discuss AVIDEL's third quarter 2024 results. 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, 2023, which was filed on February 29, 2024, and subsequent SEC filings. Except as required by law, ABIDEL 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 Davis, 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 additionally join us for the Q&A portion of the call. At this time, I'll turn the call over to Greg.

Thank you, Austin. Good morning, everyone, and thank you for joining us. Following my opening remarks, Richard will provide an update on our commercial progress, and Tom will then review our third quarter financial results. We will then conclude with a question and answer session. As we begin today's call, let me start by summarizing our Q3 results, another quarter where, once again, we delivered consistent patient growth in our LUMARISE launch while making progress across a number of additional important fronts. As we detail our launch results today, including our key metrics and how our source of new Lumerize patients continue to advance, it is clear that we have begun to make a real impact on the patients we are serving with the full recognition that we are moving to the next phase of our launch. And as such, there remains much work to be executed to deliver on the full promise and potential of Lumerize for all stakeholders. Turning to the launch metrics that Richard will cover in more detail shortly, we reported there were 2,300 active patients on therapy as of September 30th, and 700 patients who initiated lumenized therapy in Q3, resulting in $50 million in net revenue during the third quarter. More specifically during Q3, we saw the following trends. First, we see continued strong representation from all three patient segments, switch due to oxidase, and previously treated and discontinued patients. Switch patients continue to make up the largest portion of new patient starts in Q3, with most switches coming from the mixed salts oxibate product, a trend that has continued since the beginning of launch. Second, patients who are new to oxibates represent the fastest growing segment of lumerized patient starts, which is coming from both existing oxibate prescribers as well as prescribers who have never written an OXYBATE prior to Lumerize's availability. And lastly, we believe these data points are important leading indicators of the potential emerging signs of expansion in the overall market, which despite not being a core focus of our initial launch, is happening even earlier than we had previously anticipated. With this emerging expansion of new to OXYBATE patient demand, it's important to note that based on historical twice-nightly OXYBATE trends, and our early Lumerize launch data, we can expect to see lower persistency rates in this new-to-observate patient population. Richard will provide more detail on this and the actions we are taking in this regard, as we are making additional investments to support all patients transitioning onto Lumerize. Furthermore, in October, we were pleased to announce receipt of FDA approval and orphan drug exclusivity for Lumerize in treating cataplexy or excessive daytime sleepiness in pediatric patients seven years and older with narcolepsy. As with adult patients, Lumise is determined to be clinically superior to the twice-nightly products in the pediatric patient population based on its major contribution to patient care. Specifically, FDA stated Lumise's dosing provides an opportunity to minimize sleep fragmentation and disruption of sleep architecture in a way that is not possible for a patient on a twice-nightly dosing regimen of an oxfate. FDA went on to say, this is medically relevant because the goal for treating patients with sleep disorders is to restore a normal sleep pattern and a healthier sleep physiology. We've always recognized, based on direct feedback from providers, patients, and their families, the burden and limitations that first-generation oxytocin have on children with narcolepsy and their caregivers. We're proud to be able to offer Lumeise to all eligible people with narcolepsy. And in this regard, Lumeise is commercially available and is currently being prescribed to and used by children with narcolepsy. Lastly, turning to our indication and portfolio expansion efforts, enrollment is ongoing in our phase three revitalized study, where we are evaluating Lumeise's potential clinical benefit in adults with idiopathic hypersomnia, or IH. We often hear from clinicians that IH patients have difficulties physically waking up for their second dose, given the deep sleep inertia associated with IH. So, potentially having moon lines available for IH patients is not only important, but also very much needed. In addition to our IH phase three study, we continue the preclinical development of our no or low sodium morphine bedtime oxibate formulations. seeking a target product profile that is bioequivalent to Lumai and meets all FDA required standards. As this program remains in early preclinical formulation development stages, we will plan to provide future updates as and when these programs advance. Beyond our commercial and clinical progress, we recently announced the District of Columbia Court's favorable ruling affirming the FDA's approval and clinical superiority decision for Lumai based on its unique once-nightly dosing profile. We are pleased with this ruling for a number of reasons as we continue executing our launch while mitigating an important legal and business risk for the company. In summary, the third quarter represented another consistent quarter of Lumerize's launch execution bolstered by additional key developments, the pediatric approval along with the second Orphan Drug Exclusivity Award granted by FDA for Lumerize, the initiation of our IH Phase III trial, and the affirmative court decision in the District of Columbia APA litigation. As we look toward 2025 with a clear vision for growth, we remain focused on executing the near-term value drivers, including the continued launch of Lumerise and our lifecycle management efforts, all in our pursuit of realizing the full potential of Lumerise for all stakeholders. I'll turn the call over to Richard for details on our launch progress. Richard.