Avadel Pharmaceuticals plc

Greetings and welcome to Avidel Pharmaceuticals' fourth quarter and full year 2023 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 Murtaugh with Stern Investor Relations. You may begin.

Good morning, and thank you for joining us on our conference call to discuss Avidel's fourth quarter and full year 2023 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. This includes statements related to expectations regarding revenue, operating expenses, and operating break-even. 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 31, 2023, which was filed on February 29, 2024, 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. For purposes of this conference call, the company made the decision to provide certain leading launch indicators as of January 31st, 2024, in order to provide a more current snapshot of its launch progress and in consideration of the update the company provided in early January. Avidel undertakes no obligation to provide intra-quarter results in future quarters. 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 for a company update and to review Avidel's fourth quarter and full year 2023 results. Following my brief opening remarks, Richard will provide an update on our launch progress, including our key metrics through January 31st. Tom will then review our Q4 financial results and provide some commentary regarding 2024. We will conclude with a question and answer session. As most of you are likely aware, it's been a busy several days for Avidel, especially last week with the ongoing patent trial in Delaware, where closing arguments were heard this past Friday, and we are now awaiting the jury's decisions. So before we dive into the commercial and business updates announced in our press release this morning, I would like to take a moment to provide some general commentary as it relates to the current and still active patent dispute. Regardless of the outcome, we don't expect the pending jury decision in the patent trial to impact our ongoing commercial launch or our belief in the potential of Loom Runs. Given this is an act of litigation, we will not provide any further commentary or answer any questions on the trial, the underlying dispute, or the pending decision at this time. However, as we have with all key matters, we will provide an update when the trial concludes, and we appreciate your understanding on this point. 2023 was truly a monumental year for Avidel. With final FDA approval, we were able to bring Lumerize to the narcolepsy community and execute our initial launch plan. both of which have been transformational for the company and that we have worked towards for many years. In addition to the unmatched achievement of launching Lumerize within approximately one month of final FDA approval, since launch last June, Lumerize has seen strong uptake among patients and prescribers, which has been supported by the positive feedback we've received from the broader narcolepsy community. Our early launch momentum throughout 2023 has continued into this year as demonstrated by progress being made across physicians, patients, and payers, all of which Richard will provide further details on shortly. Our team's nearly decade-long dedication to advancing Lumerise and to the sleep medicine space overall has allowed us to build a foundation for continued growth and the potential expansion of Lumerise. And as such, our priorities as a company remain very crystal clear. First and foremost continues to be our focus on executing our launch strategy and delivering on the promise and the potential of LumeRise across the multi-billion dollar Oxibate market opportunity. We are proud of the momentum we are building and all we have accomplished thus far. And this is evidenced by the $19.5 million in LumeRise net revenue in the fourth quarter and the $28 million for the seven months ended December 31st, 2023. Our second and near-term opportunity is our potential expansion into the pediatric narcolepsy population. The FDA accepted our supplemental new drug application for Lumerize for the treatment of cataplexy or excessive daytime sleepiness in patients between the ages of seven to 17 with narcolepsy and provided us an action date of September 7th, 2024. We believe approval in the pediatric population will allow Lumerize to provide further positive impact to the narcolepsy community and caregivers at large. We have heard directly from parents about the challenges associated with the middle-of-the-night dosing and the burden a twice-nightly dosing regimen may create for the entire family. We believe Lumrise, if approved for the pediatric population, can offer the potential of reducing that treatment burden while also providing an effective treatment for children living with narcolepsy. We look forward to the potential approval and launch later this year. The next growth opportunity we're pursuing is LumeRise for the treatment of idiopathic hypersomnia, or IH. When speaking with key opinion leaders in the field, there is a significant need for the use of once-at-bedtime LumeRise for many suffering from the deep sleep inertia associated with IH. With a current estimated uniquely diagnosed IH patient population of greater than 30,000, We believe Lumerize, if approved for the IH indication, will be an important addition to the treatment options for those suffering from this rare sleep disorder, while also providing potentially meaningful upside to the future value of Lumerize. We are currently well advanced in the planning stages to initiate a multicenter randomized controlled trial for IH in the second half of this calendar year. And we intend to provide updates as we reach various important milestones, including when our first patient is enrolled. And lastly, we're continuing the preclinical development work of a potential no or low sodium once at bedtime oxybate formulation with a target product profile that is bioequivalent to Lumerize. And we intend to provide those updates as appropriate as well. In closing, we ended this year in a strong position with a healthy balance sheet to support our operations and our continued growth. Coupled with the progress already made this year, we believe we are well positioned to expand our reach and impact within the sleep medicine space, and most importantly, continue executing the launch of LUMRA. I am proud of the significant accomplishments and progress our team has delivered over the past year and remain highly confident that we will continue that during the year ahead. We believe we're well-positioned to advance Lumerize to command a meaningful share of the multi-billion dollar oxalate market and maintain our view that Lumerize offers a greater than $1 billion potential market opportunity. With that, I'll turn the call over to Richard for details on our commercial progress. Richard?