Avadel Pharmaceuticals plc

Greetings, and welcome to Avidel Pharmaceuticals' fourth quarter and full year 2022 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. Thank you. You may begin.

Good morning, and thank you for joining us on our conference call to discuss fourth quarter 2022 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. 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 that products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market entry and acceptance of products, and the impact of competitive products and pricing. These and other risks are described more fully in AVIDAO'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 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, Jennifer Goodeman, Senior Vice President of Medical and Clinical Affairs, Richard Kim, Chief Commercial Officer, and Tom McHugh, Chief Financial Officer. At this time, I will 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 our fourth quarter and full year 2022 results. 2023 is proving, as we expect it to be, a pivotal year for Avidel. We've already executed on a number of significant milestones, including the recent completion of multiple strategic financings that paved the way for growth and value creation as we enter the final stages to bring LoomRise, are investigational once-at-bedtime oxibate therapy for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy to the market. With an oxibate-eligible patient community of 30 to 35,000 strong and the opportunity to address the most important unmet need, which requires patients to forcibly awaken in the middle of the night during a precise 90-minute window, LumeRise offers the potential to provide OxyBait patients the opportunity to have an uninterrupted night's sleep while commanding a meaningful share of the estimated $3 to $3.5 billion once at bedtime OxyBait market. I am proud of all that our team has recently accomplished, which has put us in a very strong position ahead of a potential final approval and the commercial launch of LumeRise. As announced yesterday, significant progress has been made in strengthening the company's balance sheet, providing us with the financial flexibility and a clean 10K ahead of the potential launch of Lumerize to the execution of a series of strategic financings, which in total provides the company with approximately $200 million of committed capital to support a potential Lumerize launch and a new April 2027 maturity date for 96.2 million of our convertible notes. The total capital includes $125 million from an equity raise and up to an additional $75 million in royalty financing with RTW investments. RTW, our largest equity holder, continues to be incredibly supportive of Avidot and Loomrise, and this additional royalty financing, along with the convert exchange and equity raise, provides us with the necessary resources and balance sheet to fully support the commercialization of Loomrise for people living with narcolepsy. Tom will provide further details a little later in this call, but it is important to state emphatically that the completion of these financing actions puts us in a strong financial position to execute on our launch priorities and deliver on our mission to transform Avidel into a commercial organization and a major player in the narcolepsy space. I want to thank everyone and especially all of our investors. who have supported us during this process and your continued belief in the promise and future of Avidel and Lumerize. Turning to our progress on the regulatory front, earlier this month we submitted a minor amendment to our Lumerize NDA requesting final FDA approval. This came shortly after the REMS patent was delisted from the FDA's Orange Book in response to the unanimous three to zero panel decision of the United States Court of Appeals for the federal circuit on February 24th, affirming the previous district court ruling ordering that delisting. Based on recent interactions with the FDA and the March 1st submission date for our minor amendment requesting final approval, FDA guidance to us would suggest timing to a decision could be around two months or approximately early May. Please note, actual timing is not in our control. However, we remain committed to continuing to do all we can to try to accelerate this. If or when we learn anything more specific, we will certainly share that information as appropriate. We also recently announced that the FDA approved our pre-launch activities importation request or player for Lumerize. This has allowed us to import Lumerize into the U.S. ahead of a final approval decision and puts us in a position to potentially shorten the time to product availability. With this, we expect to be in a position to have Lumerize available in about four weeks after a potential final approval. For the near-term final approval decision and the potential for product availability shortly thereafter, we have been focused on building and preparing our organization for the potential launch of Lumerize. Richard will join us shortly to provide a further update on our launch preparations and progress. And lastly, and certainly not least, we continue to expand the patent exclusivity for Lumerize, as we've recently been granted five additional U.S. patents for a current total of 13. These 13 U.S. patents provide Orange Book listable patent protection into early 2042, with many more applications pending at the U.S. Patent Office. We have a lot to cover today, so with that, I'll turn the call over to Jennifer for details on our recent scientific data presentation. Jennifer?