Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q4 2022 Earnings Call Transcript

Greg Divis: Yes. Thanks, Adam. Richard, do you want to comment on that?

Richard Kim: Yes. Hey, Adam. Thanks for the question today. So, yes, we €“ as far as our operational perspective, as far as REMS distribution, we’re €“ the REMS is in essence programming is done. We’ll be hired €“ fully staffed for both our REMS program and our patient services center within the next couple of weeks. So that first phase we’re ready, we could be flipped to switch in just a couple weeks here as well. To your point, as Greg had mentioned, supply should be available approximately four weeks after a final approval and our team is coming on board as well. So we are ready to be able to deliver this. And yes, so all of our key components are ready to go in the next couple of weeks.

Adam Evertts: Fantastic. And then one quick one for Tom. Tom, you mentioned the second tranche on the royalty side that was triggered by a regulatory milestone or a sales milestone.

Tom McHugh: The second tranche of $45 million is on a quarterly revenue milestone.

Adam Evertts: Fantastic, thank you.

Operator: Our next question comes from the line of Francois Brisebois with Oppenheimer.

Unidentified Analyst: Hi, this is on for Franc. Congrats on all the progress and thanks for taking our questions. Just a quick one from me. In terms of the payer discussions, just wondering how useful or important are these real world outcome studies that you have been doing? And is this coming up in these payer discussions from a payer’s perspective in terms of reimbursement? Thanks.

Greg Divis: Richard, you want to go or?

Richard Kim: Yes.

Greg Divis: Sure.

Richard Kim: Yes. Hey, Dan, thanks for the questions. So I think the really great thing is with the recent regulatory and legal events have come on, the payer engagement has definitely stepped up to that next level overall here as well. And on €“ I think holistically, the good news is we’re really focusing on really strengthening the conversations around the clinical value proposition. So the team has been doing clinical presentations and I think going for, I mean, the payers are always interested in the real world evidence. So those questions do come up and I think we plan on sharing more of that as more of the data continues to be published as well. So overall, the conversation has definitely been a lot more shifted towards the clinical value proposition of LUMRYZ.

Unidentified Analyst: Great, thanks for that. And just a quick one, I believe you already talked about it, just to be clear, in terms of the REMS build out. So at this point is the €“ on the technology infrastructure standpoint, is that already completed and now staffing is the next thing.

Greg Divis: In short, Dan, that exactly correct. And staffing is ongoing now. So as Richard noted, within a matter of just a couple weeks that will be fully operational. And Jen, I know this goes under your purview, so if you have any comments you want to add, please do.

Jennifer Gudeman: You described it perfectly. So programming is complete. The staffing is taking place right now, and we’re just a few short weeks away from being ready to go.

Unidentified Analyst: Awesome. Thanks for all the updates and congrats again on the year. Thanks.

Greg Divis: Thanks, Dan.

Operator: Our next question comes from David Amsellem with Piper Sandler.

David Amsellem: Thanks. So just had a couple you talked through the challenges with middle of the night dosing. But I wanted to get your thoughts on potential counter detailing messages from your competitor, things that we’ve heard anecdotally from KOLs, like taking LUMRYZ too late at night, potential interfering morning functionality or even bedwetting. So how do you respond to that kind €“ those kinds of concerns and particularly as it relates to competition and messaging, what is your counter to those kinds of concerns? So I’ll stop there.