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

So, we are seeing our rate of discontinuation rates below the historical twice nightly claims historically. So, to your point, we see a sort of a nice build up getting more new patients on, and clearly we have a lot of efforts to appropriately keep patients on persistently over time as well. Greg, I’ll maybe pass a last question over back to you.

Gregory Divis: Yes. Just a couple of comments. First, I think, when it — as it relates to conversions and discontinuation rates, I think, with two full quarters into the launch, I think we’ve done incredibly well in both conversion to initiating on therapy and how we’ve effectively managed the discontinuation rates through all of our programs and services. So, Richard’s right. We’re really pleased where we sit, and certainly we believe are beating the benchmark relative to the existing therapies in the marketplace. As it relates to your comment about when should we guide the Street to change an expectation around the slope of the curve, right, from that standpoint? Listen, we’re not going to guide specifically around that, Andrew.

I appreciate the question, but I’ll just remind everyone that, like, there is a large number of patients who have — who are in our oxybate market opportunity. That’s upwards of 50,000 potential patients when you take in the currently existing treated patients across all forms of twice nightly oxybates, previously discontinued and new starts. We certainly expect to see us to continue to drive demand from those — all sources of those patients at this point in time. So, there’s a large pie out there, and our view is that we haven’t hit the flattening of our slope at this point.

Andrew Tsai: Great. Thanks, again, and looking forward to seeing more good news.

Operator: One moment for the next question. The next question comes from David Amsellem with Piper Sandler. Your line is open.

David Amsellem: Hi, thanks. So, on the pediatric opportunity, can you talk about realistically how many patients you could capture or percentage of the market you think you can capture with a once nightly modality? So, that’s number one. And then in IH, how are you thinking about that opportunity in terms of your ability to either expand the market, or do you think you get a lot of capture from patients who are on the low sodium, twice nightly oxybate product? Just how you’re thinking about those commercial dynamics in IH? Thank you.

Gregory Divis: Yes. Thanks, David. On pediatrics, depending upon your data source, and there’s different, if you will, claims data sources, we would — it would tell us that the actual oxybate utilization of pediatric patients relative to the total pie is anywhere from 3% to 5%. So, it’s a relatively small patient population in the context of the full pie. And part of that is because although onset of symptoms occurs between the ages, normally between the ages of 7 and 17, the diagnosis, actually the proper diagnosis, doesn’t occur to somewhere between 8 to 15 years later, which is something that certainly everyone hopes improves over time. So, from us, it really has been — it’s much less about the total patient population that are pediatrics who are being treated, and much more about really meeting the needs of that patient population and their families, right.

We’ve heard extensively from them about how disruptive waking up in the middle of the night is for parents, for the children and for their families. And so, for us, it’s a really straightforward opportunity for us to advance to this patient segment and seek approval for it. Again — so we do think there’s an opportunity to potentially expand that treated patient pool at this stage, but it’s much more about just serving a community within the total narcolepsy patient community who really is looking for the opportunity to not wake up. With regards to IH, again, with over 30,000 uniquely diagnosed patients, and an upwards of another greater than 10,000 to 12,000 patients who we would describe as diagnosed with IH and narcolepsy. And then you look at, there’s only one FDA approved drug, and you look at the penetration in that diagnosed patient population at under 10%.

We think there is a significant opportunity in IH to help more patients that are being treated. And, again, when we hear from key opinion leaders and physicians at large, the first two things we hear from them after we talk about LUMRYZ and narcolepsy is when are you going to get pediatrics, and when are you going to get IH, when are you going to study in IH? And for IH, it really is about the fact that these patients suffer from really deep sleep inertia to the extent where they’re sleeping 14, 15, 16 plus hours a day, and it’s hard for them to wake up, right. It’s hard for them to wake up. And the opportunity to not be forced to do that in the middle of the night just offers a value proposition that is — that I would say the community is very interested in with LUMRYZ.

So, we’re excited to initiate that study and update everyone on as we progress it and try to help those patients as well. And we think it’s another meaningful upside for the long term value of LUMRYZ, for sure.

David Amsellem: Okay. Thanks, Greg.

Gregory Divis: Thanks, David.

Operator: One moment for the next question. The next question comes from Ash Verma with UBS. Your line is open.

Ashwani Verma: Thanks. Good morning. Congrats from my side as well. So, I have two questions. In terms of the switch patients, can you provide some color on how much of the use is coming from Xyrem versus Xywav? A lot of us were surprised to see that Xywav narcolepsy patients are starting to flatten out in the most recent quarter. And then secondly, if you can briefly mention if you’re seeing any off-label use on the IH side? Thanks.