Avadel Pharmaceuticals PLC at Needham Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Ami Fadia - Needham & Company, LLC - Analyst : Perfect. So let's dive straight into the topic that's top of mind for everybody, which is what's going on with FT218 and when might we hear of an update. So in your last conference call and also some other conferences that you've been at in March, you talked about some interactions with the FDA that you've been having. Can you provide us with an update on where those interactions have -- what direction they've taken? Sounds like last time, you were waiting to hear back some feedback from the FDA on label. So if you could start with updating us on that.

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. Is there anything with regards to the back-and-forth on the labeling changes that you think are worth notable or anything that you can share with us on that? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 11, 2022 / 6:15PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Needham Healthcare Conference

Question: Ami Fadia - Needham & Company, LLC - Analyst : So just to be clear with regards to that patent given that its nature is -- with regard -- it's around drug-drug interaction, given your studies did not show an interaction with valproic acid. You're basically carving that out in your label. Is that okay?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Got it. I wanted to just go back to the one area which most investors are focused on, which is orphan drug exclusivity, and whether that might be a reason for FDA taking time to make its final decision. You indicated in your last update that in a meeting or a discussion with the FDA, you'd had the opportunity to ask some questions about that and you felt comfortable that that wouldn't be a hurdle to approval. Can you update us on any new interactions with the FDA perhaps since January that may have thrown any new light on that topic?

Question: Ami Fadia - Needham & Company, LLC - Analyst : So it sounds like you're talking about the case of the Aquestive. Are there any parallels that you can draw between your situation and theirs that make you feel comfortable around your ability to get approval for FT218?

Question: Ami Fadia - Needham & Company, LLC - Analyst : And have there been any questions from the FDA with regards to data supporting an orphan drug exclusivity for FT218 in the last couple of months?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. Perhaps moving onto kind of the litigation aspect of it, that would be the next area of focus post a FDA decision, if that's an approval. Do you still anticipate a preliminary injunction motion from Jazz? And what would be your latest expectation around a timeline to address that and get a decision from the judge?

Question: Ami Fadia - Needham & Company, LLC - Analyst : And I would imagine that -- so when would we hear of when exactly or which specific claim Jazz intends to research in a PI motion?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Understood. Okay. So let's move on to commercial launch prep. Once you receive approval from the FDA, what are some of the items in the critical path between approval and launch of the product? Can you lay that out for us? Of course, we talked about the PI, which is obviously the big next step. But in terms of other operational readiness, what should we be focused on?

Question: Ami Fadia - Needham & Company, LLC - Analyst : So with regards to the REMS program, of course, you've defined the REMS. And then the next step is for you to get physicians trained and enrolled in the REMS program. Typically, what -- how much time do you anticipate that to take?

Question: Ami Fadia - Needham & Company, LLC - Analyst : And so in my mind, REMS is one piece, and the other is really getting the launch quantities approved by the DEA and then manufactured and ready to go. Can you talk about how these two -- well, can we talk about the timeline and the steps required to get that part done? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 11, 2022 / 6:15PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Needham Healthcare Conference

Question: Ami Fadia - Needham & Company, LLC - Analyst : So two follow-ups here. One, can you give us a sense of the DEA quota for this year? And then secondly, how long would it take post -- once you receive the label to really get up to completing the packaging?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Got it. And just as a reminder to the audience, the primary packaging is -- could you just describe it? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. APRIL 11, 2022 / 6:15PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Needham Healthcare Conference

Question: Ami Fadia - Needham & Company, LLC - Analyst :

Question: Ami Fadia - Needham & Company, LLC - Analyst : Got it. Okay. Can you talk about your distribution strategy for FT218 and how that may be different from what has been used for the existing sodium oxybate product?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Understood. Okay. Can you talk about your salesforce hiring efforts and where you are with regards to identifying and putting offers out versus your target?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Can we talk about the payer coverage? You've talked about some preliminary discussions that you've been able to have with payers in the past months and maybe more than a year. But once you receive approval, then how long would it take to get clarity on or get these contracts signed with payers, so that there's a line of sight or sort of visibility into how patients get approved for their coverage?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Got it. Okay. I'd want to just get a little bit of a preview into how you think about the launch dynamics. Just given where we are in the year and the expectation for a generic Xyrem to launch sometime at the turn of the middle of the year, you will be launching in the face of generic Xyrem. And how do you anticipate the dynamics to play out with that from a pricing perspective and also where would your sales reps target in terms of where some of the early patients on FT218 could come from?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Now with the sales reps size that you're going to launch with, do you think that that would be adequate to tap into the market beyond the existing sodium oxybate users? Or do you think down the line, you would need to consider expanding that?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Understood. Okay. Perhaps I'll take audience questions here. I guess the question is really around trying to understand -- and there are a couple of questions on this topic. It's really trying to understand the timeline of when you might be able to get that decision from the FDA. It seems like we've been closed for a very long time. And so is there better visibility that you have on the timeline today than you did maybe a month or two ago? And if you've had further interactions with some of the senior management at the FDA to be able to give you that visibility?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Got it. The other question is can you frame for us the alternatives that you may pursue should the FDA decision gets delayed significantly from here? And what drives that? We can always debate, but what is the plan B or C that the company is thinking about should FT218's approval get significantly delayed even off of where we stand today?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. Perhaps maybe I'll end with the last question. I'm being told we are almost at the end of our time, but as you think about the balance sheets, where would you invest your capital with regards to research and development? In terms of pipeline, you've talked about couple of different directions you would take, but what would be the one that would be the low-hanging fruit that you would try to pursue?

Question: Ami Fadia - Needham & Company, LLC - Analyst : Okay. With that, I think we are almost out of time. So let me close our conversation here. Greg, always good to speak with you. And thanks to the audience for joining and listening in.