Avadel Pharmaceuticals plc (NASDAQ:AVDL) Q3 2023 Earnings Call Transcript

And then as we think about going forward, the really nice thing about our execution is when we think about our narcolepsy treaters and prescribers, it’s a very concentrated physician base, 4,500 make up the entire universe, 1,600 80% of the volume. So those naive and discontinued patients generally are in the same offices the people that we’re seeing where these switch opportunities are as well. So I think what we’ve seen is it sort of depends where the patient the physician is on their journey, but we’ve also sort of seen a nice uptick in both the previously discontinued and the patients as well. So we’re just very pleased to sort of see the pull-through of our strategy and growth coming from all 3 patient segments.

Gregory Divis: Yes. I think, Rudy, to some extent, it’s also a bit of a math equation as well because there are just meaningfully more patients in offices who are on existing therapies today than those who are truly newly diagnosed, that the average annual newly diagnosed rate is around 3,000 patients per year, and 80% of those are in our primary targets. The average target has 1 or 1.5 patients per year. So again, those will continue to come in the ordinary course. As they come in, and we certainly are messaging around the importance of LUMRYZ for new starts as well. But I think also you’re seeing just a manifestation of, early in the launch, kind of the math equation of more intervention opportunities for those who are on therapy than those who are coming in as potential new starts.

Rudy Li: Got it. That’s very helpful. Can you also talk about the gross to net? Any color would be helpful.

Gregory Divis: On the gross to net?

Rudy Li: Yes.

Thomas McHugh: Yes. So listen, at this stage of the launch, we’re early, and we haven’t quite reached a steady state on gross net. There’s more payer contracting to be done. — payer mix is certainly going to affect the gross to nets. But as we’re looking forward, we think continues to be a reasonable target to assume really on a net revenue per patient basis, is about $120,000 per year. We’re not there today, just to be clear. We have patients that are starting therapy going through a titration schedule on lower doses. But ultimately, as we move forward to a steady state we think that $120,000 per year per patient is a reasonable assumption.

Operator: Our next question comes from Matt Kaplan with Ladenburg Thalmann.

Matthew Kaplan: I think we’re as in a nice quarter. Just wanted to dig a little bit more into the process of patients passing through or working their way through the RYZUP system. And can you give us a little bit more detail in terms of the percentage of patients that start in RYZUP that actually initiate therapy?

Richard Kim: Matt, thanks for the question. As far as process is concerned, it’s really sort of broken up into 3 key steps. The first is really the enrollment form, which is almost synonymous with the prescription really beginning the process. And that really getting is going, where then the next phase is really the benefits investigation, where they sort of checking out the insurance that the patient has. And including that amount of time is going to be very depending on whether or not there’s coverage or not. . But then the third step is in the process is when the specialty pharmacies get to be involved and they begin to triage the patients to ultimately confirm the shipment date with the patients. So those are what we call are really placenta processes, maybe one that’s a little bit unique to us is one last requirement that is aligned to our REMS process as well as specialty pharmacies for LUMRYZ have to confirm whether or not there’s an overlay of treatment with another oxybate.

So that does take a little bit longer, adds a little bit to the process, but those are really the 3 key steps that go forward. And what we can say is our processes are working very well. We’re seeing that with the fulfillment today. And we do expect the time lines for fill rates to continue to improve as well. And your second question again, Matt?

Matthew Kaplan: And kind of the percentage of patients that actually that enter the RYZUP and then initiate therapy at this point?

Richard Kim: Yes. I mean, the way we can sort of maybe do the math right now sort of go through where we are thus far is like, we announced over 1,000 enrollments through September, 400 initiated. And I think Greg also had some commentary also on the 600 patients were in the process. What we see first is we’ve seen very few of those drop out, and we do expect going forward that the majority of these remaining 600 or patients to be initiated onto LUMRYZ. So the numbers are some of the math is somewhere between those numbers there as well. We also expect the majority of those to be initiated on to reimbursed product as well. So once again, like it’s — these are probably the parts that are the most focal point for us early on the launch, but we’re really pleased with the progress that we’ve made. We’re pleased that we’re actually getting patients on to LUMRYZ. And as we said, we believe that our conversion rates will just improve as time goes on as well.

Matthew Kaplan: And in terms of the time to move through the RYZUP process, do you expect that to improve as similarly with getting the preferred position with CVS starting at the beginning of the year, with other payers coming online as well and moving to a preferred position? Or do you think it would kind of still remain the same in terms of kind of 1 month to treatment for prior auth patients?

Richard Kim: Yes. It’s a great comment, Matt. Yes, I think you sort of nailed it. First is sort of that mix, the sort of patients coming through with coverage versus those who don’t. And obviously, we sort of see the covered lives continue to improve as we go forward here as well. So yes, that should actually improve our overall time lines. And then what happens as well, as the offices just get more experienced and more familiar with our process. So both of those are occurring, it’s very dynamic, but we see both of those as drivers for us to improve our efficiency going forward.

Matthew Kaplan: And then maybe last question. One of the goals you have is expanding the existing oxybate prescriber base. Obviously, that’s a longer-term goal, we are very early in the launch. But can you tell us a little bit about what you’re seeing so far early in the launch in terms of expanding the prescriber base to new prescribers?

Richard Kim: Yes. Sure, Matt. Right now, at the beginning of the launch, we’re much more hyper-focused on those with oxybate experience and the 1,600 who have — who manage 80% of total prescription volume. But here’s what’s been going on. First, you go into office, there may be someone who had previously never prescribed, that now you want to come in the mix when we’ve been going in to see one of the more highly experienced oxybate prescriber. But the other thing that’s been going on is we’ve just sort of seen spontaneous people coming to our REMS certification that we hadn’t called on, who have put their hand up and have begun the enrollment process as well. So although it’s not been a focal point for us, it’s been nice for us to sort of see people coming out of the woodwork that maybe weren’t really in our intention to call on as well.