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

Chase Knickerbocker: Makes sense, Richard. Thank you.

Richard Kim: All right. No problem. Thanks, Chase.

Operator: One moment for the next question. Next question comes from Marc Goodman with Leerink. Your line is open.

RudyLi: Thanks for taking my question. This is Rudy on the line for Marc. Congrats on the strong results. So, I have question regarding the market dynamics. Do you see the total oxy market continue to expand in the coming years? I’m also curious about your thoughts on the opportunity of the oxy products. And do you see any potential impact in the oxybate in NT1 versus NT2, and IH? Thanks.

Gregory Divis: Thanks, Rudy. Richard, do you want to take that as well?

Richard Kim: Yes. No. Thanks, Rudy. Yes. So, as far as the market dynamics is concerned, yes, prior to launch, we had done six different quant market research studies that really showed with the introduction of LUMRYZ that the oxybate market could expand with the new patient starts somewhere in the neighborhood of 30% to 50%. It’s hard for us to sort of say right now, because some of the other data from other companies is no longer as visible as it used to be. So, we’re — what we’re definitely seeing right now is a few things. One is, we’re getting more people who had never prescribed an oxybate previously into the mix who prescribed. And we’re seeing obviously strong penetration within existing oxybate prescribers. So, we definitely believe we’re sort of seeing some of the dynamics of patients going beyond using LUMRYZ, where they maybe were more limited with twice on the oxybates.

And as far as I think your question around orexins are concerned, for us, we’re very excited to see any new treatment modalities that could potentially come to the marketplace. Obviously, those companies still have to go through the clinical and regulatory process as well. The first one that we sort of see is focusing more on NT1. I guess, a couple of things that we sort of see when it comes to orexins, they look to be really fabulous weight promoting agents, maybe a little less certain around their impact on sleep. And, clearly, there’s a lot of questions around the overall benefit risk profile between efficacy and tolerability as well. But the one thing we do know overall is this tends to be a polypharmacy marketplace. It has been in the past, and it likely will be in the future as well.

So, we believe that LUMRYZ is well positioned not only in NT2, but clearly because of the benefit that it has in NT1 as well. So, I think, we’re still early on there as well. But one thing that we always consider, oxybates are used today in about less than 10% of patients who are diagnosed and under care for narcolepsy. So, we still see there’s lots of room for oxybates to grow, as Greg had mentioned previously. And we believe we’re well positioned today and also as new therapies come out in the future as well.

RudyLi: Thanks.

Gregory Divis: Thanks, Rudy.

Operator: One moment for the next question. Next question comes from Matt Kaplan with Ladenburg Thalmann. Your line is open.

Matt Kaplan: Hi, good morning, guys. Thanks for taking the questions. I guess, maybe, can you provide some more color in terms of what you’re hearing with respect to how important the low sodium formulation is in the marketplace right now and your strategy there as you move forward your formulation?

Gregory Divis: Richard, do you want to talk about that?

Richard Kim: Yes, I’ll take the first part there, Matt. Thanks. So, yes, candidly, from our field, we hear a lot less objections about sort of sodium content overall. I’d say, a couple of things. First, there’s — we now have sort of our team out there as well. Secondarily, one of the key publications that our team uses is a publication that came out in 2020, where sleep experts from Stanford and UCLA looked at sort of the history of twice nightly sodium oxybate. And their conclusion was that there was really no difference in cardiovascular outcomes on patients on twice nightly sodium oxybate products at that time. So, I think, candidly, what’s happened is science is sort of being focused on here, and there’s good published data that’s able to be used.

And there’s also — there is another company out there talking about the benefits of what a once bedtime therapy can do overall. So, we really haven’t sort of heard as much of that in the field. There is — there clearly are still some HCPs focusing on that. But I think now as patients are — HCPs are getting experience with LUMRYZ and seeing the benefit of what it can offer to their patients, I think that’s held a lot of weight with those offices as well. And I know, Greg, if you want to talk about our lower sodium as well.

Gregory Divis: Yes. I think, in that regard, Matt, I think our view is that there are patients who have sodium sensitivities or other comorbidities that may require them to accommodate for that in their oxybate treatment choice, and we want to make sure all those patients have an opportunity to be on a once at bedtime therapy option. So, that’s why we continue to proceed with it. And from that perspective, we think everyone should have that option.

Matt Kaplan: Okay. That’s helpful. And then a second question. In terms of the IH opportunity, you stated that you plan to launch your study second half of this year. Can you give us more detail in terms of the potential timeline there — and — of that program?

Gregory Divis: Yes. I think, it’s a little bit premature to guide specifically on when we think enrollment will be completed or whatnot. We clearly will initiate in the second half of this year and have every incentive to do that as early as we possibly can. There’s just a lot of work that has to go in in terms of starting up a trial, and we’re well into that now, whether that’s CRO selection or site selection and feasibility assessments at the site level, clinical supply, placebo manufacturing, all those sorts of things. So, all of that is happening now. So, we’re well on track from that perspective. And so, we’ll cover more. We’ll provide more context as we get into it, for sure. But the team has done an excellent job to kind of ramp that up relatively quickly since the back end of last year, and we’ll have more to talk about in the near future, for sure.