Avadel Pharmaceuticals plc

first quarter 2025 earnings call. At this time, all participants are in a listen-only mode. Accompanying slides for this call can be found on Avidel's investor relations website. 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 Murtaugh with PrecisionAQ. Thank you. You may begin.

Good morning, and thank you for joining us on our conference call to discuss Avidel's first quarter 2025 earnings. As a reminder, 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, 2024, which was filed March 3, 2025, 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 Dennis, Chief Executive Officer, and Tom McHugh, Chief Financial Officer. I'll now turn the call over to Greg.

Welcome, everyone, and thank you for joining us to discuss Avidel's first quarter 2025 results. On today's call, I will provide insights and commentary on the drivers of our performance during Q1 and the outlook for the remainder of this year. I'll conclude my opening remarks with additional company updates that we believe will further strengthen and accelerate our business in the future. Tom will then provide an overview of our financial performance and guidance, and we'll wrap up with a Q&A session. To start, let me underscore our continued confidence in Loom Runs, which saw accelerated patient adoption and expanded physician prescribing throughout the first quarter of 2025, further building on our early launch momentum. We are pleased with the strong progress we made during the first quarter of the year and remain confident in our ability to continue to deliver on our growth plan. Accordingly, as noted on a press release, we raised our full year guidance. We are equally pleased with yesterday's favorable decision from the Federal Circuit Court of Appeals regarding Avidel's ability to pursue indications for lumerize beyond narcolepsy. The Court of Appeals rejected key elements of the Delaware trial court's injunction that had prohibited us from applying for FDA approval for Lumerize for any indication beyond narcolepsy, from offering open-label extensions to trial participants using Lumerize, and from initiating new clinical trials or studies with Lumerize. This is a clear win for Avidel and for patients, as we are now able to proceed with the development of Lumerize for additional indications, conducting clinical studies, and seeking FDA approval for those indications, including IH. Since the beginning of 2025, we have seen improvements across our key launch metrics for Lumerize, including patient enrollments, new patient starts, persistency rates, and most importantly, the accelerated growth of net new patients on therapy. This progress reflects the investments we have made in strengthening our leadership team, refining our commercial strategy, providing additional patient support, expanding our customer-facing roles, and as such, expanding our provider and patient engagement. While we are pleased with these promising early results, we're not remotely satisfied and expect to build on this momentum through the remainder of this year and beyond. We ended the first quarter with 2,800 patients on Lumerize, reflecting 100% growth over the same period last year. Additionally, we re-accelerated the growth of net new patients during Q1, delivering an increase of 300 patients, which is a 50% increase compared to the fourth quarter of 2024. Lastly, despite the typical Q1 seasonality headwinds, we generated $52.5 million in net revenue, which represented greater than 90% growth versus Q1 of 2024. Our commercial performance underscores the strong clinical value proposition of Lumerize and its unmatched advantage as a one-set bedtime oxidizer. Given the positive momentum year to date, we are raising our revenue guidance to $255 to $265 million for the full year. Tom will provide additional details related to this later in the call. As you may recall, effective January 1st, we increased our sales force by 15%, expanding our target focus and our sales team capabilities. The execution of this and related initiatives resulted in positive patient demand growth across all patient segments during Q1 versus Q4, including growth in switch patients, starts, and an expansion of our Lumerize prescriber base. We are encouraged by the continued expansion of new riders who previously, according to currently available data, had not prescribed an Oxibate, but who are now beginning to prescribe Lumerize. We believe this is another strong data point highlighting how Lumerize is both competing in the Oxibate market and growing it. Complementing our sales force, we doubled the size of our field reimbursement team. This expansion, which also took effect January 1st, has rapidly demonstrated the ability to drive additional patient starts faster while enabling this team to spend more time in the field directly engaging with targeted prescribers and their office staff, all of which has resulted in an improvement in new patient starts across all patient segments in Q1 when compared to Q4. And lastly, we turn our attention to the expansion of our nursing support team, which also doubled in size effective January 1st. This is our team who is directly engaging with patients prior to, at the start of, and during their lumen rice treatment. In Q1, we saw an improvement in persistency, or in other words, a decrease in our discontinuation rate when compared to Q4. Importantly, that improvement occurred across all patient segments, including new to OxyBait patients. and in particular, during the first 90 days of treatment. This positive impact is a result of both the expansion of the team and the implemented training that is designed to both assist patients getting onto therapy and also provide ongoing support during their lumerize treatment. The cumulative impact of these positive trends has resulted in a reacceleration in the growth of the most important patient metric, which is net new patient ads, where we delivered 50% growth in Q1 versus Q4. Furthermore, the additions of our new commercial leaders in sales and patient services have been positive catalysts to our recent performance. We expect this will be further enhanced by the impending appointment of our next executive commercial leader. From a timing perspective, we are in the very final stages of this process and expect to announce the appointment of a highly accomplished and experienced rare disease leader who we believe will elevate our capabilities and accelerate our performance. Now, moving beyond Lumerize's launch in narcolepsy, a few additional updates that are key to Avidel's future growth and value creation. First, enrollment is progressing and on track in our Phase 3 revitalized trial evaluating Lumerize and idiopathic hypersomnia. As previously communicated, we expect to complete enrollment in the trial before the end of 2025 and are targeting top-line data in the first part of 2026, followed by an NDA filing thereafter. To give you a sense of the size of the IH opportunity, there are approximately 42,000 patients diagnosed and only one FDA-approved treatment available today, which has reached approximately 10% of that population. If approved for use in IH, we believe Lumirise has the potential to unlock a significant additional unrealized market opportunity. Prescribers regularly express their excitement about the future prospect of being able to prescribe Lumirise for indications beyond narcolepsy and specifically IH. We consistently hear that having an uninterrupted, predictable, consistent, and fully prescribed oxybate dose night after night is important to patients and physicians. Luminize currently offers that potential for narcolepsy patients who have difficulty staying awake and believe it is only an intuitive to extend that potential possibility to IH patients who struggle with waking up. With clear market potential and vocal community support, we believe Lumerize, if approved, is well-positioned to potentially transform the IH patient experience. Beyond Lumerize, we are advancing efforts around a once-nightly no or low sodium oxibate program aligned with the target product profile that is bioequivalent to Lumerize. We believe this alternative formulation could serve as an additional compelling treatment option to serve patients dealing with hypersomnia-related disorders who could also benefit from the opportunity of an uninterrupted, predictable, consistent, and fully prescribed OxyBait treatment night after night. Now, moving briefly on to our litigation, we remain confident in our comprehensive legal strategy. And while we're waiting for decisions on certain prior matters, we are actively pursuing the following actions against Jazz to protect and further build our business. First, our ongoing defense in the initial patent lawsuit, where, as noted, we won an important appeal yesterday. Next, the antitrust case against Jazz, currently scheduled for a jury trial in early November, in which we are seeking total potential recovery well in excess of a billion dollars. And finally, our recently initiated offensive patent suits, in which we are asserting the once-nightly use of their mixed salts product in IH, as described in its label, infringes five Avidel patents, and which reflects our unwavering commitment to protect our intellectual property. Wrapping up my opening remarks, we're encouraged by the progress made across all aspects of our business, and in particular, the reacceleration of our Lumerize Narcolepsy franchise and yesterday's court decision. We remain focused on sustaining this momentum as we continue working toward a long-term goal of a billion dollars in lumerized narcolepsy revenue while expanding our impact to potential patient populations in the future who may also benefit from a once-at-bedtime lumerize, leveraging our innovative technology platform. With that, let me turn the call over to Tom to walk through our financial results. Thanks, Greg.