Avadel Pharmaceuticals plc

Welcome to the Epidel Pharmaceutical Second Quarter 2025 earnings call. At this time, all participants are in a listen-only mode. Accompanying slides for this call can be found on Epidel Investor Relations website. The question and answer session will follow the formal presentation. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your first speaker, Austin Murtaugh, with Precision AQ. You may begin.

Good morning, and thank you for joining us on our conference call to discuss Epidel's Second 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 Epidel'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, Epidel 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 Divis, Chief Executive Officer, Susan Rodriguez, Chief Operating Officer, and Tom McHugh, Chief Financial Officer. I'll turn the call over to Greg.

Welcome everyone, and thank you for joining us to discuss Epidel's Second Quarter 2025 results. Following my opening remarks, Susan will provide an update on our continued commercial progress, Tom will review our financial results, and I will conclude with a Q&A session. We are incredibly pleased with the results we achieved in the second quarter, including growing patient demand with 3,100 active patients on Loom Rise as of June 30, a 63% increase compared to the second quarter of last year, generating 68.1 million in Loom Rise net revenue, a 64% -over-year increase, and delivering -over-quarter improvement in key patient metrics, including persistency, percent of reimbursed patients on therapy, and patient mix. Additionally, the second quarter marked our eighth consecutive quarter where we added new patients from all three patient segments, we expanded use from repeat Loom Rise prescribers, and added new prescribers, both OxyBate experienced and those who previously never prescribed an OxyBate, which underscores how Loom Rise is not only competing in the OxyBate market, it is also expanding it. We also achieved important financial milestones in the second quarter, as we generated $15 million in cash, and for the first time since launch, net income of nearly $10 million resulting in earnings per share of 10 cents. Given the positive momentum and improving trends in the first half of 2025, we are raising our full year 2025 revenue guidance to $265 to $275 million, reflecting our confidence and our continued commercial execution, combined with the positive impact the investments we've made are having. Additionally, to further support Loom Rise's future growth opportunity, based on the positive return we have seen to date with our incremental investments, coupled with Susan's leadership and insights, we continue to identify new areas for targeted investments we believe can further propel patient demand for Loom Rise and expand patients on therapy. Susan will discuss these dynamics shortly. We are pleased our 2025 launch investments are yielding tangible improvements as Loom Rise uptake remains robust, patient persistence continues to improve, while new patient starts are occurring more efficiently and being reimbursed at a higher rate. Furthermore, Loom Rise's novel extended release profile provides additional significant growth opportunities with potential expanded indications across other hypersomnia disorders. Specifically, based on physician and patient insights, we continue to be excited about Loom Rise's significant potential in idiopathic hypersomnia, or IH, and view this, if successful, as a meaningful opportunity to amplify Loom Rise's potential positive impact on even more patients. To recap our progress on IH, in June we received orphan drug designation from the FDA for Loom Rise's use in IH on the hypothesis that Loom Rise may be clinically superior to current approved therapies and provide a major contribution to patient care due to its once nightly dosing regimen. Specifically, FDA stated for the third time, Loom Rise may provide a major contribution to patient care due to its once nightly dosing for patients with IH, a chronic sleep disorder that requires potentially lifelong treatment. This is an important milestone for us, as the unmet medical need in IH remains high with approximately 42,000 diagnosed patients, limited to a single FDA approved first generation oxybate therapy that is currently only reaching approximately 11% of that population. If approved for use in IH, Loom Rise could potentially enable eligible patients to experience an extended release oxybate treatment for the first time, providing an important benefit for this population that struggles so significantly with sleep inertia. By offering an innovative novel therapeutic option that is specifically designed for the patient to receive a full therapeutic dose night after night with the added benefit of no forced awakenings, we believe could elevate the standard of care in IH and potentially unlock a significant expanded oxybate market opportunity for Loom Rise. That said, enrollment in our phase three revitalized trial evaluating Loom Rise and IH is ongoing and enrolling patients at approximately 40 leading US sleep centers. We are well on our way to completing enrollment in revitalized by the end of 2025, followed by data readout in 2026 to support a potential future supplemental NDA filing during the second half of 2026. If approved, we believe Loom Rise could transform the treatment of IH, improve care for patients and further demonstrate its clinical and commercial potential in idiopathic hypersomnia. In addition to the pursuit of the IH indication, we continue to advance our efforts on the potential to expand our oxybate portfolio to include an extended release formulation, providing a once at bedtime dosing regimen with a low or no sodium profile. The target product profile for this formulation program continues to be bioequivalence to Loom Rise. We believe that offering this expanded oxybate portfolio option could serve as an additional complementary treatment option that addresses the potential needs of all eligible patients suffering from our approved indications, who deserve the proven efficacy of a consistent full therapeutic oxybate treatment night after night with a once at bedtime dosing regimen providing the potential added benefit of uninterrupted sleep. Our continued investment in this strategy is reflected in part by our increase in operating expenses and related guidance for the second half of 2025. We currently expect to provide an update on this program by year end. Now, touching briefly on our litigation, in June we were pleased that the U.S. Court of Appeals unanimously affirmed a prior decision in favor of the FDA in a suit brought by Jazz Pharmaceuticals. The appeals court ruling removes any doubt that Loom Rise will remain available for narcolepsy patients and affirmed the FDA's determination that extended release Loom Rise is clinically superior to all first generation immediate release oxybates and that its once at bedtime dosing provides a major contribution to patient care. In addition to this important court victory, we're actively pursuing additional legal actions against Jazz to protect our rights and intellectual property, including, but not limited to, our antitrust case, which is currently scheduled for a jury trial beginning on November 3rd of this year, whereby we are seeking total potential recovery in excess of $1 billion. To wrap up my opening remarks, we are encouraged by the progress made across all aspects of our business and in particular the execution of our commercial team, which is driving the strong performance of our Loom Rise narcolepsy franchise. This, combined with the work we are doing to expand potential future patient populations who could possibly benefit from Loom Rise, along with our continued progress on the litigation front, sets us up for a strong second half of 2025 and continued positive momentum and growth into the future. With that, I'll now turn to call over Susan for details on our commercial developments. Susan.