Avadel Pharmaceuticals plc

Greetings and welcome to the Avidel Pharmaceuticals fourth quarter and full year 2021 earnings call. At this time, our participants are in a listen-only mode. A question-and-answer session will follow the formal remarks. As a reminder, this call is being recorded. It is now my pleasure to introduce Brandi Robinson. Thank you. You may begin.

Good morning, and thank you for joining us on our conference call. This morning, we've issued our press release providing a corporate update and financial results for the quarter and full year ended December 31st, 2021. 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. Forward-looking statements are subject to risk 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 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 yesterday, as well as 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. Doug Williamson, Chief Medical Officer, and Tom McHugh, Chief Financial Officer. Richard Kim, Chief Commercial Officer, and Dr. Jennifer Guteman, our Vice President of Medical and Clinical Affairs, will additionally 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 highlighting the progress made toward potential FDA approval and commercialization of FC-218, including a brief update on our commercial readiness activities. Dr. Williamson will then provide a summary of the new data recently presented at World Sleep 2022. Tom will then review the financial results for the quarter, including an update on our recent convertible maturity extension, We will conclude with a Q&A session when we will be joined by Richard and Jennifer. As we head toward what we believe will be a full approval and launch for FT218, there are four priorities for the company that are mission critical to ensure we realize the full potential and value that FT218 can create for patients, for shareholders, and for Avidel at large. Number one, and most importantly, is the FDA taking a formal action on our FT218 NDA and granting our full approval. Number two, continuing our deep understanding of the market opportunity and the clear, unmet need for OxyBait-eligible patients that goes well beyond the current OxyBait-treated patient population. Number three, the significant progress we are making in preparing the company and the narcolepsy community for the potential future launch of FT218, including launch readiness and data generation. And finally, number four, the strengthening of our balance sheet to ensure maximum flexibility to achieve our business objectives. So let's begin our update with priority number one, the one topic on everyone's mind, which is the status of our NDA review for FD218. Earlier this year, we sent in additional edits to the draft label, and we confirmed with the agency at that time there were no additional questions or information requests pending. We were given no specifics on the timing of the completion of our review, and subsequently requested a meeting with more senior officials from the FDA to clarify timing and any remaining review items. Based on these and subsequent exchanges, let me share with you what we have been told directly by the FDA. First, we have reconfirmed that there are currently no outstanding questions or information requests and that the last and final remaining matters are as communicated to us administrative, and internal to the FDA. Furthermore, within the past week, the agency confirmed to us that they are working on the FT218 label and expect to send it along with any potential follow-up comments back to us soon, which is the language used in writing to us by the FDA. We share this detail so our stakeholders know we are continuing to take action to move this forward with all means at our disposal. And we have always expected that the next step upon completion of the FDA's internal and administrative process is for us to receive an updated, proposed, and potentially final label. And now, based on this very recent and direct feedback, we have been informed that it is currently being worked on and is expected to happen soon per the FDA. Completing this next step on the label, we believe, is an important step forward toward the potential full approval of FT218, which takes us to priority number two. As it relates to the market opportunity and unmet need of OxyBate eligible patients, we have continued to conduct extensive patient and healthcare professional research, research which continues to inform and confirm that FT218, if approved, can command a meaningful share of the narcolepsy treatment market among OxyBate eligible patients including the potential to expand the treated oxibate patient pool. We believe this is important to understand because, despite the introduction of an additional twice-nightly oxibate formulation over the last 15-plus months, there has not been a meaningful increase in the number of narcolepsy patients being treated with any form of the twice-nightly oxibates. And through our extensive research, we have learned that the introduction of once-at-bedtime FT218 will be well-received by current high-volume oxibate prescribers and can expand the utilization of oxibates with physicians who currently prescribe at low volumes or even not at all. Physicians we have surveyed indicated their intent to switch patients as well as increase their oxibate utilization upon the potential approval and launch of FT218, including those who currently do not prescribe any twice-nightly oxibates. Furthermore, very recent patient research informs us that the majority of oxibate-eligible patients, whether naive to therapy, previously treated with oxibates, or currently on either of the twice-nightly formulations, have self-reported as being interested or significantly interested in learning more about once-at-bedtime FP218 and, if approved, interested or significantly interested in initiating therapy with FP218. and this includes those who have recently switched to the twice-nightly mixed salts formulation as well. All of this only confirms what we have seen in our past research, that there is a clear need for a once-at-bedtime option like FT218 for OxyBait-eligible patients, whether on therapy currently or not, due to the challenges associated with having to wake up in the middle of the night, thus providing Avidel a significant opportunity to positively expand the OxyBait-treated pool almost exclusively to our benefit. The potential full approval and launch of FT2 and 8, combined with a market opportunity that is meaningfully larger than the current approximately 16,000 patients and nearly $2 billion, requires significant market preparation and launch readiness actions, for which over the last year and specifically the last few months, we have made tremendous progress and leads us to priority number three, Under the leadership of Richard and his experienced team, they have significantly progressed our overall launch readiness across all commercial and launch-related functions. This includes but is not limited to the selection and setup of our specialty pharmacy distribution partners, the continued development of our patient services center and REMS, which are prepared to advance upon FDA approval, meaningful engagement with payers with a focus on the three large PBMs representing approximately 85% of commercially insured lives, the identification and selection of nearly 90% of our sales team with offers accepted pending FDA approval, and lastly, customer-facing activity generating significant interest from healthcare providers at live medical congresses, including most recently at the World Sleep Congress in Rome that just finished yesterday. Another key component of our launch readiness is to highlight the publication of key data to continue to scientifically demonstrate the potential clinical benefits of once-at-bedtime FT218. Before we hand it over to Tom to conclude with our fourth priority, which is our financial performance and balance sheet-related actions, I am pleased to introduce to you Dr. Doug Williamson, our newly appointed Chief Medical Officer, to review the highlights of the most recently published clinical data from WorldSleep 2022. Doug, the floor is yours.