Avadel Pharmaceuticals plc

Greetings, and welcome to Avidel Pharmaceutical's second 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 Murtaugh with PrecisionAQ. Thank you. You may begin.

Good morning, and thank you for joining us on our conference call to discuss Avidel's second quarter 2024 results. 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 Avidel'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, 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, Richard Kim, Chief Commercial Officer, Dr. Jennifer Goodman, Senior Vice President of Medical and Clinical Affairs, 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 this quarterly update. Following my opening remarks, Richard will provide an update on our launch progress. Jennifer will walk through our phase three idiopathic hypersomnia, or IH, clinical trial. Tom will then review our second quarter financial results, and we will conclude with a question and answer session. The second quarter marked the one-year anniversary of introducing Lumerize to the market, and I'm immensely proud of the work done by our team and the impact we have made within the narcolepsy community. From the start, we recognized that OxyBait-eligible patients deserved a once-at-bedtime treatment option that addressed their needs where first-generation OxyBaits fell short. Our team's relentless determination in serving people with narcolepsy has been the driving force behind our tremendous progress. Since launch last year, we have seen our pre-approval market insights materialize in real time, which when combined with the strong foundation we have built only reinforces our confidence in the significant opportunity that Loom Rights offers in our pursuit of its potential billion-dollar-plus opportunity. Specifically, we point to the following. We have seen consistent, strong uptake from patients switching from the twice-nightly, first-generation OxyBait products, the majority coming from the mixed salts formulation. Demand is growing from both naive patients and patients who have previously tried and discontinued twice-nightly OxyBaits, a patient segment many had discounted. And the launch of Lumrise has resulted in the expansion of new OxyBait prescribers who had previously never written an OxyBait script And additionally, physicians who are now treating more patients with OxyBase, specifically with Lumerize, than prior to our launch, resulting in new patients coming into the OxyBase market that prior to Lumerize were not accessible or potentially interested. These important data points only confirm what our research informed us, that the OxyBase market opportunity for Lumerize is both significantly larger than that of the first-generation OxyBase and is unique primarily to Lumerize alone. With that, we are pleased to report that there were more than 1,900 patients on therapy at June 30th, and we generated $41.5 million in net revenue during the second quarter of 2024. Additionally, as Tom will cover during his review, based upon how we exited Q2, we currently expect that we will generate operating income in Q3, an important financial milestone we will have achieved during the first full calendar year of launch. As announced last week, we dosed our first patient in our phase three revitalized trial, evaluating Lumerize's potential benefit in the adult IH population. Based on feedback from physicians and experts in the field, we believe Lumerize has strong potential to improve care for those living with IH through its unique extended release formulations. In addition, we are expecting a potential approval decision by the FDA for our supplemental new drug application for Lumerize's use in the pediatric narcolepsy population. The target action date is set for September 7th. If approved, we believe Lumerize has the potential to address the needs of both pediatric narcolepsy patients who could benefit from a full therapeutic dose of inoxibate given in a once-at-bedtime formulation and the caregivers who currently have to awaken in the middle of the night, night after night, to administer a second dose of a first-generation Oxibate to their children. Lastly, we continue our development work on a potential no or low sodium once-at-bedtime Oxibate formulation with a target profile that is bioequivalent to Lumerys. As previously stated, we expect to have an update by the end of 2024. In summary, after one year of launch and with an eye on the future, we believe LumeRise is well-positioned in its pursuit to become the preferred oxibate among patients and providers as we continue to positively impact the multibillion-dollar oxibate market opportunity. I'll now turn the call over to Richard for details on our commercial developments. Richard.