Avadel Pharmaceuticals plc

Ladies and gentlemen, thank you for standing by, and welcome to the Avidel Pharmaceuticals first quarter 2022 earnings call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star, then 0. I would now like to hand the conference over to your speaker, Ms. Brandi Robinson, Senior Vice President of Corporate Affairs. Please go ahead.

Good morning, and thank you for joining us on our conference call. This morning, we issued our press release providing a corporate update and financial results for the first quarter ended March 31, 2022. The release can be found on our website, www.avidel.com. 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. The 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 information regarding products in the development stage that 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 Avidel's public filings under the Exchange Act included in the Form 10-K for the year ended December 31st, 2021, which was filed on March 16th, 2022, as well as subsequent SEC filing. 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 Divitz, Chief Executive Officer, Dr. Doug Williamson, Chief Medical Officer, Tom Nehue, Chief Financial Officer, and Richard Kim, Chief Commercial Officer. Dr. Jennifer Guteman, our Vice President of Medical and Clinical Affairs, will be available for Q&A following the call. At this time, I'll turn the call over to Greg.

Thank you, Brandi. Good morning, everyone, and thank you for joining us for our call. I'll start off by providing an update on our business and specifically providing additional commentary on the process and current status of the potential FDA approval and launch of FT218. I'll then turn the call over to Doug to give an overview of the data we have recently presented. Tom will review the financial results for the quarter, and Richard will share updates regarding our launch readiness plans. We will conclude with a Q&A session when we will be joined by Jennifer. Since the beginning of 2022, across many critical areas of the company, we have made significant and important progress. Our launch readiness has been exceptional. Our customer insights have informed us that the commercial opportunity for FT218 is significantly larger than the current OxyBait-treated narcolepsy patient population, and the clinical data we have presented continues to be incredibly well-received and confirmatory of the benefits of a once-at-bedtime OxyBait treatment. With that said, we fully appreciate the progress that everyone is most interested in is with the status of our NDA review and the potential FDA approval for FT218. Although we'll cover launch readiness and clinical data during our call today, we will begin with providing an update on the status of the FDA's ongoing review. We detailed in March 2022, on our call in March of 2022, the actions we had taken as of mid-March, including escalating the matter to more senior FDA staff, and as a result, we learned a number of important things, including the There were not any additional questions or information requests for us, and as such, we believe that the substantive review of the NDA is complete. But the remaining matter under review were communicated to us by FDA as administrative and internal to the agency, and we've been assured by FDA officials that work was occurring on our application and that we should expect to hear from them soon, including providing us further updates to our label and any associated questions they may have. Since our public commentary in March, we have had consistent communication and additional follow-up with the FDA, which has included further edits to and harmonization of the current draft FT218 label and associated medication guide. Based on where we are today, if the label comes back to us from the FDA in its most recent form or even close, we would be very pleased with that result. Furthermore, as a result of our ongoing efforts and persistent engagement, we now have clarity on who we believe are involved with the remaining administrative and internal matter to complete the review of FT2 and 8. This includes not only senior members of the review division, but also FDA leadership and staff from the Office of Regulatory Policy and the Office of Chief Counsel. We are engaging directly with these staff, and based on very recent interactions, we expect further follow-up within this month in response to our repeated outreach regarding specificity on the remaining administrative review and timing to a final decision. Once again, the FDA has continued to inform us that at this time, there are no additional questions, information requests, or data needed from us to help them complete the review. My final commentary on the status of the NDA before we move on to the other company updates is very straightforward. We've worked directly with the review team, we've escalated to more senior FDA staff, and have worked very urgently, diligently, proactively, and professionally to advance FP218. As we have moved forward, we've not only escalated our direct engagement with the FDA, we've also escalated our related actions. This includes our expanded advocacy support and activation, broader key FDA stakeholder outreach and engagement, and all potential regulatory and legal actions as well. We are using all available options to advance FT218 and address the current unmet needs of all eligible patients seeking a new treatment option within the narcolepsy community. We understand and live the frustration all stakeholders have regarding the status of our NDA as we continue our efforts to bring FT218 to a full approval. As we have shared with the FDA, every day we disappoint patients who are contacting us wanting to know when FT218 will be approved and available. The significant interest in once-at-bedtime FT-218 continues to remind us every day of how important and how valuable FT-218 is for patients, the company, and our shareholders. And to be clear, we will not relent in our pursuit to bring FT-218 to a full approval, nor will we relent upon approval in our commercialization efforts to build a blockbuster treatment for those we serve. First, the opportunity for all OxyBait-eligible patients, treated or untreated, is too important in helping them potentially live a more normal life. And second, the opportunity to build significant shareholder value is also too important to not use every internal and external resource available to us in our pursuit of approval and launch. Before I turn it over to Doug, I would like to extend my sincerest gratitude to our employees. I am extremely proud of their dedication, their resilience, and their tenacity during this period of time. I'm excited for what is to come for Avidel, and as importantly, excited about the prospect of providing a one-step bedtime FT-218 to people living with narcolepsy. With that, I will now turn the call over to Doug. Doug?