Avadel Pharmaceuticals plc

greetings and welcome to the avidel pharmaceutical second quarter 2023 earnings call at this time all participants are on 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 murtaugh with stern investor relations thank you you may begin good morning and thank you for joining us on our conference call to discuss second quarter 2023 earnings as a reminder before 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 include risks regarding the success of commercialization efforts for Lumerize, expectations regarding the potential market impact anticipated market availability and sales opportunities of Lumerize, and the impact of competitive products and pricing. These and other risks are described more fully 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 any 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 Divis, Chief Executive Officer, Dr. Jennifer Goodman, Senior Vice President of Medical and Clinical Affairs, 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 today to review our second quarter 2023 results. 2023 continues to be a transformational year for Avidel, which has only accelerated with the significant progress our team has delivered in the second quarter alone. And this all starts with our transition to a commercial stage organization and the launch of Lumerize, our once-at-bedtime oxybate therapy for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. Following Lumerize's approval in May, along with the concurrent receipt of orphan drug exclusivity, we swiftly executed our launch strategy and since launch in June have seen impressive interest and initial uptake from physicians and a broad mix of patients. We recorded our first sales for Lumerize in June and based on our initial launch progress, we are trending well against our expectations at this very early stage in the launch. With clear and unwavering focus, we are honored to be able to bring forward our transformational once-at-bedtime therapy the narcolepsy community has long been waiting for. On today's call, I'm joined by Richard, who will be providing updates on our commercial launch progress. Following Richard, Jen will be discussing our robust clinical presence at the Sleep Conference and our recent publications. We will then turn the call over to Tom to update on the financial results. And lastly, we will close the call with a question-and-answer session. Before commenting on our launch progress, I want to take a moment to highlight the receipt of orphan drug exclusivity in May. At the same time, the FDA granted Lumerize final approval, as this is an important validation of the benefit of Lumerize. The FDA found Lumerize to be clinically superior to all twice-nightly OxyVe products in that Lumerize makes a major contribution to patient care by providing a once-nightly dosing regimen that avoids nocturnal arousal, which disrupts sleep architecture, when required to be forcibly awakened in the middle of the night to take a second dose. As many of you know, at the end of June, we held a widely attended Loon Rise commercial day, where we highlighted the significant opportunity of Loon Rise, demonstrated our history of resilience, showcased our talented team, reported initial launch metrics, and discussed how we were well positioned for future growth. In addition, we hosted two renowned sleep specialists who spoke about their extensive experience with treating narcolepsy patients and how they believe Lumerize will positively impact the treatment landscape for people with narcolepsy. We were also honored to have a person with narcolepsy in attendance who gave a firsthand account of her experience living with narcolepsy, first-generation oxybates, and how Lumerize positively transformed her life. Today, we are updating initial metrics previously reported. Specifically, the three most important early launch KPIs that we reviewed at our commercial day and are now reporting data through the first two months of launch. The significant progress we have seen across these important KPIs during these early weeks of launch are as follows. First, REMS certifications, which is the first step before a prescription can be written, are now greater than 1,000 targeted prescribers who are certified. That's up from 625, as previously reported. Second, new patient enrollments into Rise Up, our patient services center, which is the first step to a potential future dispense of Lumerize, are now greater than 400 patient enrollments, up from 140 as previously reported. And third, progress on the reimbursement front, which is also performing ahead of expectations. which now includes the addition of Loomrise to the Express Scripts National Formulary, and now, hot off the press, CVS Health has removed the new-to-market block for Loomrise on its commercial formularies in a non-preferred position. This decision now allows a pathway to coverage for more than 30 million additional commercial lines. In summary, from a leading KPI perspective, while recognizing we are only in the first full quarter of launch right now with significant work ahead of us, We are pleased with these early indicators of our launch progress. Looking at future quarters as our launch progresses, we expect the KPIs that provide a current picture of launch to evolve. And our goal, as it always has been, is to be transparent as we report metrics that capture our launch progress. Further, we expect to give all launch KPI updates on our quarterly earnings calls, where all data provided will be as of quarter end. Looking toward the future in the continued growth of Avidel, our strategy is to target opportunities that allow us to expand our patient reach in the rare sleep space with the goal to provide innovative therapies like Lumerize to more eligible patients. In this regard, our team is on track to submit a supplemental new drug application for potential FDA approval of Lumerize in the pediatric narcolepsy population before the end of the 2023 calendar year. Additionally, we are progressing the clinical planning to initiate a multicenter randomized controlled trial in idiopathic hypersomnia. And lastly, we continue our preclinical stage formulation work of a potential no or low sodium once-at-bedtime oxibate formulation for the small subset of sodium-sensitive oxibate-eligible patients who could potentially benefit from this type of innovation. We look forward to providing updates as appropriate as physicians and patients have expressed significant interest in Avidel developing these needed treatment options. Although it's very early with much more to accomplish during the first few full quarters of launch, we are very pleased based on our early launch KPIs with our initial execution and continued pursuit of greater than the $1 billion peak sales potential opportunity that is there for Luma. I will now turn the call over to Richard to provide an update on our launch progress. Richard. Hey, thanks, Greg, and good morning, everyone.