Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q4 2023 Earnings Call Transcript

Gregory Divis: Richard, do you want to?

Richard Kim: Yes, no problem. Thanks for the questions, Ash. So, yes, as far as switch patients are concerned, we do see more coming from the mixed salts or Xywav than we do from the twice nightly sodium oxybate segments overall as well. Just a couple perspectives there. When we did market research early on in the mixed salts launch, we saw that a lot of patients there tended to be earlier adopters of newer therapies. And maybe we’re seeing some of this here as well. There are some — there are more patients in the marketplace on the mixed salts version right now as well. But, fundamentally, what we also hear is the amount of wet salts that are associated with the GHB really had no impact on the narcolepsy outcome. So, it’s really not much surprise to us that we’re seeing more patients switching from the twice — from the mixed salts version than the twice nightly sodium oxybate versions as well.

And to answer your question about off-label usage, clearly, first and foremost, we don’t promote any off-label usage, but we have seen requests for off-label usage for both pediatrics and for IH patients as well.

Ashwani Verma: Thank you.

Gregory Divis: Thanks, Ash.

Operator: One moment for the next question. The next question comes from Myriam Belghiti with LifeSci Capital. Your line is open.

Myriam Belghiti: Thank you. Good morning. Just a quick question for me. Can you comment on patient type signing up to the RYZUP program and if you see any differentiation than those that ultimately receive therapy? Is it a similar process for naive patients, discontinued patients and such patients going through the RYZUP program?

Gregory Divis: Richard, do you want to take that?

Richard Kim: Yes. Sure. Thanks, Myriam. So, yes. Yes, the process is quite similar, because the way I describe the RYZUP enrollment, it’s almost like a prescription. And the only reason it isn’t is because we have the three different specialty pharmacies within our network. So, the process is generally initiated by the provider. And the amount of information that’s required depending on what type of patient you are is generally the same if you are a switch, with the exception of a box which indicates if you had former usage of an oxybate. So, yes, we seem to be generally consistent across the board there as well. And we’re clearly very pleased to sort of see strong demand coming in through RYZUP as well.

Myriam Belghiti: Okay, got it. And then you spoke of a KOL led speaker program today. Can you provide a bit more detail on what that entails?

Richard Kim: Yes. We — one of the things that’s very important, if you think about it, beyond the terrific work that our medical team has done with publications and presentations at scientific medical congresses, it’s pretty much been our voice carrying the word for LUMRYZ. So, we now have a speaker bureau. We have trained experts in narcolepsy across the country who are now doing speaker programs on our behalf. We’re generally speaking to other super providers and some of their colleagues within their offices, and it’s been really great to sort of see we did quite a few of these programs as we exited Q4 of last year. We have executed many more of those programs in Q1 of this year. And we’re also doing things such as like national programs as broadcast programs as well.

So, it’s really a great opportunity to get a fair and balanced sort of perspective out on LUMRYZ and the narcolepsy marketplace. And the reception and the turnout has been really positive to, sort of, see that many sort of sleep specialists that have come out to these programs. So, getting that peer-to-peer education out for HCPs we think is quite critical. And these speaker programs are a very important tactic for us to execute that.

Myriam Belghiti: Okay. Got it. Congrats again on the great year.

Richard Kim: Thank you.

Operator: One moment for the next question. Our next question is from Chase Knickerbocker with Craig-Hallum. Your line is open.

Chase Knickerbocker: Good morning, guys. Yes. Great update. Share my congrats as well. So, I just want to maybe better characterize those patients that sit in the RYZUP program for longer. In some instances, it looks like much longer than the one month average you kind of mentioned. So, just kind of generally, what are the characteristics of these patients that sit on the program? And do they not just meet the — do they just not meet the PA criteria? And then should we still think of kind conversion rate there reaching very high numbers, or some of these patients just going to sit on the program? Thanks.

Gregory Divis: Richard, do you want to take that?

Richard Kim: Yes, sure. Thanks, Chase. Yes. So, it’s a great observation as far as some of these patients who have been in the process for longer. To your point, the general characterization is they may not have met the prior authorization criteria or in some cases they weren’t covered live. What we’ve sort of seen with the process is then it’s a medical necessity or it’s going through an appeal and a denial process. Now, one of the things we’re very proud of, what we built with our RYZUP team as well, is the tenacity of the team there to not give up on these cases. So, while on one hand we’re very focused on sort of faster turnaround time, especially for patients who meet all the criteria, to your point, we’re also not giving up on these longer standing cases.

So — and generally what we have seen is a pretty good success rate oftentimes after many rounds of appeals and denials going through where we still can get a large portion of these patients initiated onto reimbursed therapy as well. So, to that point where we see sometimes enrollments that started back six months ago who can ultimately get onto therapy as well. So, it’s still relatively early to sort us for us to figure out what those success rates should look like. But we are still seeing on a monthly basis, sort of what we would call more aged RYZUP cases who are successfully able to get the therapy sometime several months later.