Avadel Pharmaceuticals plc

Greetings and welcome to Avidil Pharmaceuticals' first quarter 2024 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 Morton with Stern Investor Relations. Thank you. You may begin.

Good morning. and thank you for joining us on our conference call to discuss Avidel's first quarter 2024 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 Abadel's public filings under the Exchange Act, included in the Form 10-K for the year ended December 31st, 2023, which was filed on February 29th, 2024, and subsequent SEC filings. Except as required by law, Abadel undertakes no obligation to update or revise any forward-looking statement contained in this presentation to reflect new information, future events, or otherwise. On the call today are Greg Divis, Chief Executive Officer, Richard Kim, Chief Commercial Officer, and Tom McHugh, Chief Financial Officer. 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 our first quarter 2024 results. Following my opening remarks, Richard will provide an update on our launch progress, including our key metrics through March 31st. Tom will then review our Q1 financial results, and we will conclude with a question and answer session. I'm pleased to report another quarter of strong execution and results of our Loom Rise launch. We continue to deliver on our ability to reach the narcolepsy community and drive significant quarter over quarter growth across our early launch metrics. Metrics we believe are critical to building a strong foundation for Loom Rise, both in the near term and in the long term. While our top business priority and focus remain on the launch of Loom Rise, during Q1, we also made important progress in our efforts to expand our reach into those living with idiopathic hypersomnia, or IH, as well as pediatric patients with narcolepsy, both of whom can possibly benefit from LumeRise, and if approved for those uses, offers potentially significant incremental value and future growth opportunities for LumeRise beyond narcolepsy. Since launch last summer, our team has begun to deliver on the promise of LumeRise in our pursuit of becoming the market leader and achieving preferred OxyBait status among patients and providers. Our early robust uptake among patients and physicians provides unequivocal evidence of this progress and of the opportunity based on the clear, unmet needs of OxyBate-eligible patients, evidence that has been further solidified by the consistent and compelling patient, caregiver, and provider feedback we routinely hear. As we now approach our first full year in the market with Loom Rise, I continue to be impressed by the relentlessness and the results being delivered by the entire Avidel team. It is their collective efforts, contributions, and achievements that have established the initial foundation for Loom Rise, which we believe positions us very well to achieve our future aspiration and expectation of achieving market leadership. Underscoring the results we announced this morning, Since the launch of Lumerize, greater than 2,800 patients have enrolled into Avidel's Rise Up patient support services program, and greater than 1,700 cumulative patients have initiated Lumerize therapy. In addition, in Q1 of this year, we generated $27.2 million of net revenue. The results we achieved continue to show the strength and the opportunity of Lumerize's position in the evolving narcolepsy treatment landscape. And as a team, we are laser focused on the launch of Luminize and ensuring we continue to deliver on the promise of Luminize to the narcolepsy community. And we are well positioned to continue advancing the launch and driving growth for Luminize and narcolepsy and beyond. In this regard, while our launch focus and priorities are very clear, we are also in parallel beginning to make real progress on specific future growth opportunities we believe can deliver additional long-term value for patients, for the company and our shareholders. Our first near-term opportunity is our potential expansion into the pediatric narcolepsy population, which represents approximately 5% of all OxyBait-treated narcolepsy patients. Our supplemental new drug application for Lumerize has been accepted by the FDA, and a target action date is set for September 7th. We believe Lumerize, if approved for this use, has the potential to address both patient and caregiver's unmet needs. while potentially offering a transformational treatment option for pediatric patients and their families. We look forward to hearing the FDA's decision later this year. Next, as we have previously shared, we are evaluating Lumerizer's use for the treatment of IH. During Q1, we've made significant progress in our readiness to initiate a pivotal phase three trial for IH in the second half of this calendar year. Similar to pediatric narcolepsy, we have heard from many experts in the field that there is a clear and compelling need for once-at-bedtime lumerize for those suffering from IH due to the associated deep sleep inertia making it extremely difficult for some patients to even wake up for their second dose of an immediate release oxidant. We are currently on track to dose our first patient in the second half of this year and plan to provide additional details at that time. Additionally, we are progressing the preclinical development of a potential no or low sodium once-at-bedtime oxibate formulation with a target product profile that is bioequivalent to Lumerize. For this program, we currently expect to provide updates by the end of 2024. In summary, we have a number of opportunities to continue to build our leadership in the sleep space and, most importantly, positively impact even more patients. These opportunities will continue to be supported by our launch execution for Luminize and Narcolepsy, which has created a strong foundation for continued growth. And with that, I'll turn the call over to Richard for details on our commercial progress. Richard?