Avadel Pharmaceuticals at Leerink Conference: Strategic Growth Plans

On Wednesday, 12 March 2025, Avadel Pharmaceuticals (NASDAQ: AVDL) presented at the Leerink Global Biopharma Conference 2025. The company highlighted a strategic focus on launching LumRise and overcoming recent challenges, such as a Q4 slowdown. Avadel’s leadership expressed optimism about early Q1 improvements and a long-term goal of reaching $1 billion in revenue, despite facing some legal hurdles.

Key Takeaways

• Avadel launched LumRise, targeting new-to-oxybate patients and aiming to improve market performance.
• The company plans to expand its sales force and support teams to address patient discontinuation rates.
• Financial projections include a net increase of 900 patients on therapy by the end of 2025.
• The company aims to achieve $1 billion in revenue, requiring approximately 8,000 reimbursed patients.
• Legal issues, including patent litigation and antitrust lawsuits, were discussed with timelines and likelihoods.

Financial Results

• CFO Tom detailed financial expectations, projecting a net increase of 900 patients on therapy from end-2024 to end-2025.
• Growth is anticipated to be more significant in the latter half of 2025.
• Strategies to increase switch patients and manage the impact of generics were outlined.

Operational Updates

• CEO Greg emphasized the importance of LumRise’s launch, noting an initial strong foundation but acknowledging Q4 challenges.
• The company expanded its sales, field reimbursement, and nurse teams to improve patient metrics and persistency rates.
• Early Q1 trends show favorable improvements, addressing issues from the previous quarter.

Future Outlook

• Avadel targets switch patients and those who have previously discontinued oxybate, aiming for 8,000 reimbursed patients.
• The long-term goal is to reach $1 billion in revenue, leveraging multiple patient segments.
• The company is optimistic about future trends and the potential of the idiopathic hypersomnia application.

Q&A Highlights

• Analyst Mark inquired about sales strategies, new patient acquisition, and revenue generation.
• Management highlighted reinvestment in sales and support to boost growth.
• Legal matters, including idiopathic hypersomnia litigation, were addressed with timelines and strategies.

For a detailed understanding, readers are encouraged to refer to the full transcript below.

Full transcript - Leerink Global Biopharma Conference 2025:

Mark, Analyst: and Tom, CEO and CFO, for joining us. It’s been an interesting launch and obviously, there was a little bit of a reset. And maybe, Greg, just I’m going to give you a few minutes just to kind of make some opening comments and just give people a little bit of, here’s where we are right now, here’s what we’re talking about, here’s kind of the latest.

Greg, CEO: Yes. Thanks. And thanks for having us here and allowing us to participate in this great meeting. Here’s a little bit of a, you know, kind of where we see where we are today, right? I think if you go back to a little over eighteen months ago, we launched after an approval within approximately four weeks, which is really record setting in terms of time to launch and accesbate from that perspective.

And since then, we’ve systematically continued to grow and build our foundation of LumRise. And I think most importantly, as we exited December with over 2,500 patients on therapy, if you look at that in context of patient additions to our franchise vis a vis our competition, we’re nearly we started and have, more than almost three times as many patients on therapy added to LumRise than our next closest competitor during this same period of time. We think it’s representative of the clinical value proposition that LumRise has. We’re sourcing patients from all different patient types, whether it’s naive patients, previously treated, who discontinued and switched patients from that standpoint. So we really feel, the foundation we’ve built has been quite strong, and the launch has started off in a really good way.

I would also add that the thing we’re also proud of is the fact that we’ve added hundreds of physicians who have never written an oxibate before. So we really believe LumRise is actually expanding the oxybate market in terms of bringing more patients into the treatment mix for an oxybate. We clearly noted in the back half of last year and in particular as we got into and through Q4, some changes in our launch and some market dynamics. We’ve seen a shift toward new to oxybate patients. And as a result, we saw an increase in our discontinuation rates or a reduction in our persistency rates, which certainly affected our business in Q4.

Things that required us to take, an urgent action on, which we’ve done, we’ve made a number of really important changes as we’ve navigated through Q4 and entered Q1 of twenty twenty five. Changes, including some people changes, but also most importantly, we’ve really focused our investments on a few areas to, you know, course correct the things that were emerging in the marketplace to really improve the launch trajectory. And, you know, those things include expanding our sales force to get more reach into the prescriber universe, expanding our field reimbursement teams who really provide support to get patients on therapy faster, and then expanding our nurse our nurse team who really are are responsible for helping the patients stay on therapy. And those three things have gone really live full on as of January 1. And we’re pleased, you know, where we are today is we’re pleased with the trends we’ve seen inside the quarter.

All of our primary launch metrics that we look at from a patient perspective are all trending and favorable to where we were in Q4. And all of them are at or above our internal expectations. So it gives us a lot of confidence that what we’re focused on is the right things to drive the improvement in the launch. And our expectation is that those improvements will continue on through the balance of this year, become more durable and sustainable, which should result in us adding more patients to therapy and obviously more revenue to the LumRise launch from that standpoint. So from a launch perspective, that’s the update.

We’re also very focused on extending our franchise through our lifecycle management initiatives. We’re well into our Phase three, revitalized trial for idiopathic hypersomnia, which we expect to complete enrollment later this year and top line data at the beginning of next year. And we’re continuing our work on a once nightly no or low sodium formulation as well. So a lot going on, a lot of focus and really pleased with the progress we’ve made as we turn the year and made these investments to drive the performance of the business.

Mark, Analyst: So just to back up and make sure everybody is level set. The number of OxoVATE patients are sixteen thousand, seventeen thousand, is that a fair number, somewhere in that range in total for all of OxoVATE?

Greg, CEO: Yes. I think historically, it’s been about fifteen thousand to sixteen thousand. And when you look at the addition of Lumerise to that, I think your estimation is not

Mark, Analyst: The market’s grown a little bit as you come in. Okay.

Tom, CFO: Yes. I mean, I’ll just add to that. Our view is that it’s been consistent since we launched that there’s 50,000 OXIBATE eligible patients is what we think about this population.

Mark, Analyst: And what makes them OXIBATE eligible? Because there’s probably more narcolepsy patients than that, right?

Tom, CFO: Yes. Across The U. S, rough estimate, one hundred and sixty five thousand diagnosed patients. The fifty thousand is our estimate based on three patient segments, some of whom are already treated with twice nightly, some are treated with Lumerize. But then a very large patient population for patients who have never been exposed to an OxoBate as well as patients who had previously tried one of the Twice Nelly products and discontinued a number of months ago.

And we see some of those coming back into the market and trying Lumerise.

Mark, Analyst: How many new patients do we get a year coming into Oxipate? You think three thousand?

Greg, CEO: If you look at historical, it’s been as low as 3,000 and high as five thousand over the last number of years. So we look at it really in the kind of 4,000 to 5,000 range is what we’ve seen more recently as in terms of truly new to OXIBATE patients annually.

Mark, Analyst: And of those new patients, what do you estimate that you grabbed over the past twelve months?

Greg, CEO: Yes. It’s hard to really determine that exactly relative because we don’t see what’s happening inside of the business with the other products, and we’ve lost visibility to the authorized generic and the original twice nightly formulation from that standpoint. But I think when we think about market share or market penetration, we’re seeing our new to oxybate continue to grow. And from our view, we’re rapidly gaining ground on the mixed salts product.

Tom, CFO: Right.

Mark, Analyst: So after discontinuations, the number of patients on therapy moves from two thousand five hundred at the end of twenty twenty four to three thousand four hundred at the end of twenty twenty five, right. Is that basically kind of the guidance? So just walk us through how you get there, like how we should think about that, Tom?

Tom, CFO: Yes. It’s a, I’d say it starts at the top, right, with patients and prescribers who initially just expressed an interest in Lumerise. So we refer to that as an enrollment. That’s the start of the process. From there, we have a team internally who works on getting that patient onto therapy.

And then persistency is a factor that comes into play or discontinuations in the reverse of that, which ultimately leads to patients continuing on therapy.

Mark, Analyst: How does the quarters play out throughout the year? I think that’s important to kind of make sure we talk about because it is it’s not just linear, right?

Tom, CFO: That’s right. What you referred to earlier, Mark, it’s at the midpoint about what we’d estimated was about nine hundred net increase about net 900 patients on therapy from the end of twenty twenty four to the end of twenty twenty five. The way we thought about our guidance and our expectations is that we build during the year, starting with Q1, coming off of Q4, and then getting incrementally better into Q2, but really see more significant growth happening in the second half of the year. Some of the programs that Greg mentioned and investments we made in the launch, they went into effect on a hard day, oneonetwenty five. And as those things become more effective and more operational through the course of the year, we expect to see more benefit throughout the year in terms of revenue.

Greg, CEO: Yes. And I think the thing for us that’s positive as the year has started is that our early launch underlying metrics that we’ve seen as a result of these investments are really pacing at or ahead of our expectations. So it doesn’t change the fact that we think the cumulative effect over time will be we’ll see greater impact in the future on these things we’re doing today. But those things the things we’re working on today, we’re seeing improvements already, which we think is very favorable

Mark, Analyst: for us. So just to talk through the new patient starts in the first quarter will be the least number of new patient starts on a quarter than the four quarters and then second quarter should be bigger than the first and third and fourth should be bigger than the second. Is that how to think about this?

Tom, CFO: Yes. Thinking about Top of

Mark, Analyst: the funnel.

Tom, CFO: Yes. Thinking about from the top of the funnel to the patient starts, that is our expectation is that we continue to build throughout the year and increase those very key important patient metrics throughout the year.

Greg, CEO: Yes. And I think the most important patient metric, at the end of the day, the metric that matters most besides revenue is net patients on therapy. Net patients on therapy is a representation of patients at the top of the funnel, reimbursed patients going through the funnel and then obviously our efforts to positively impact persistency.

Mark, Analyst: Let’s talk about persistency a little bit. What did you think persistency was going to be before you launched? Where are we today? How are you thinking about it over the next year?

Greg, CEO: Yes. I think when you think about where we are today, I think the best way to think about persistency in terms of how we’ve performed, let’s just go back to Q4 for a minute, if we can. And if you look at our business in Q4, we started Q4 with 2,300 patients on therapy, right? We added another 600 patient starts. So we have 2,900 patients inside the quarter who had been on LumRise.

As we exited the quarter, we exited at 2,500. So we had 400 patients who discontinued. So you think about that in a percentage basis, that percent is about fourteen percent, right? So when you think about what happened in Q4, that’s where our discontinuation rate are. Our persistency rate, the opposite of that is from that standpoint.

Our expectation is through the investments and initiatives we’re deploying, we will see that improve throughout the balance of Q4. Our original expectations, in part driven by the patient mix in Q4, we thought maybe that number would go up a little bit in Q1. But we’ve seen really nice reaction to our initiatives and progress in our initiatives. So we’re pleased with what we’ve seen at least through the first nine or ten weeks of launch of the quarter in terms of persistency and the actions we’ve been taking to try to improve persistency in that regard. So again, I think that’s the way to think about the metric and the performance.

And our expectation is we will improve that as we go throughout the course of the year. Year.

Tom, CFO: Yes. It’s certainly an important metric and we’re working at it. To Greg’s point, we’re pleased with the trends we’re seeing so far in Q1. And as that metric continues to improve, of course, it improves our revenue outlook.

Mark, Analyst: So the biggest surprise that you probably had was that there were less patients who were switching from other oxibates and there was just mostly new patients coming on. And new patients are not used to the OXIBATE in general, so they’re just more likely to stop, right? And so how do we get more switches this year?

Greg, CEO: Yes. I think the one thing that’s very clear is we’ve continued to generate switches quarter after quarter over quarter. We’ve seen that ratio in the back half of last year trend down as a percentage of total patients starts decline with a growth in new to oxybate patients. There’s two things from our perspective that really drove that, that we needed to address. Number one was we needed to expand our commercial focus and our, if you will, our selling efforts beyond what we’ll characterize as our initial original targets.

Right? We needed to go broader to more physicians and deliver a consistent commercial execution across a wider, group of oxibate prescribers or potential oxibate prescribers from that standpoint. We’ve done that. And in Q1, we’ve already seen that group begin to be a big reason why our growth, our improvement in some of our underlying patient metrics have emerged because we’ve seen those physicians begin to write more or write for the first time with some consistent commercial execution. So that’s that’s a key aspect of it.

And another key component of it, which may sound very simple and fundamental, but it is, is we needed to build the right sort of incentive structure for our teams to drive the right sort of behavior, to drive the right sort of efforts, to deliver the right sort of patient mix that we want to have to build LumRise during this phase of the launch.

Mark, Analyst: So basically what you’re saying is you changed the bonus structure to move more towards switch patients. Is that what you’re saying?

Greg, CEO: Yes. It’s we evolved and changed the bonus structure to provide greater opportunities for our colleagues and our sales teams depending on patient mix and prescriber mix, right? So it’s both an opportunity to drive more switch patients, but also to expand their prescriber base at the same time.

Mark, Analyst: Did you notice Jazz do anything different last year just in defense that, you know, now you can play offense against their defense, like, you know, differently or

Tom, CFO: Yes.

Greg, CEO: I can’t say that, you know, the competitive tactics have changed dramatically from that standpoint, from what we can tell, from that perspective. It’s really important that when it comes to switch patients, obviously, the value proposition for a new to oxygenate patient is quite obvious from that standpoint with Lumerise’s benefit as a once nightly, once at bedtime dosing option for patients. For switch patients, you have to continue to sell through it. You have to continue to talk physicians through it. We need to give our teams the right sort of incentives to for them to go through that effort to both drive more switches and expand the breadth of prescribing.

Mark, Analyst: What have you noticed from just the whole generics coming on board, the authorized generics? Like how has that changed anything about your business?

Greg, CEO: For us, it really hasn’t, in terms of our focus at this early stage of the launch, only six full quarters in at this point. You know, we certainly have to, you know, plan for what may come in terms of generics in 2026. The authorized generic that’s been in the market for, you know, since before we came to the market has really had nominal impact on, from my view, on the branded oxivate marketplace and on Lumri specifically. It’s been much more of a conversion from the original twice nightly sodium oxivate product. The when we think about the future and we think about potentially a multisource generic market, for us, we don’t think it precludes us from having opportunity to continue to grow.

And the reason why we believe that is because, as Tom talked about, the patient segments we target, the new to OXIBATE patient, which is where likely payers will favor, potentially a multi source generic or a low price generic to the original twice nightly formulation, is the smallest segment for which we’re capturing patients from potentially. Right? We still have switch. We still have previously treated. And if for some reason, which we’re not sure if this will play out, but if every new to OXO BATE patient has to you have to step through that to get to a brand that OXIBATE, it in essence becomes predominantly a switch market.

And we see the switch data today across all the products. And LumRise is by far gathering by far the most switches. So to us, it still creates the same opportunity for us and creates an opportunity to continue to grow, even in the face of, generics.

Mark, Analyst: Well, maybe to tag on to that, is it easier to switch a patient who was on the original Oxipate or the low sodium Oxipate, you know? Zywave, Ziverem, you know what I mean? Like, is it easier?

Greg, CEO: Yeah. For us, they’ve come from both, right? Since launch, we’ve gotten a lot from both of them and the authorized generic as well. So I can’t say one is easier or or than the other because we’ve sourced it from all of them.

Mark, Analyst: I mean, but you would think that it would be easier for to take from Ziram, I would think, just because their whole spiel is low sodium, right? That’s basically what they’re saying. So, you know

Greg, CEO: Yes. Again, from a patient perspective, you know, we certainly have seen patients on the mix salts product opt in for Lumerise because they value the benefits of what once nightly administration, once a bedtime dosing means for them vis a vis their benefits. And clearly, the FDA made it very clear that they think that dosing of LumRise constituted a major contribution to patient care and granted us orphan drug and clinical superiority.

Mark, Analyst: You started to talk about this one. I’ll make sure we come back and quantify it. The number of prescribers oxibates. So how many prescribers of oxibates are out there? How many are prescribing your product versus Jazz’s product?

You know, like what and how much are you changing and where are they coming from and how much are they, you know, are the writers deepening the number of prescriptions for you? Just give us a sense of what’s going on there.

Greg, CEO: Yes. There’s approximately historically, about 4,000 approximately 4,000, Oxivate writers in a year, maybe a little bit more than that some years, from that standpoint, but 4,000, of which really 1,600 of them make up 80% of the prescriptions, right? So heavily indexed on the top end of the funnel, so to speak. Today, Lumrise has generated well in excess of 2,200 unique prescribers. We’ve had a few hundred actual docs in that call group in that universe who have never written an oxibate before, who have not written Lumerise, have become some have become regular writers of oxibates as a result.

So for us, there’s clear indications that, you know, not knowing what’s happening with all of the other products in the category because we don’t have a lot of visibility to their volume that isn’t reported, we are certainly adding prescribers to the prescriber universe who’ve never written oxibates before and therefore patients who are not in the, if you will, the denominator of the oxibate market. So from that perspective, I think Lumerise, we feel quite confident that we’re doing our part to try to grow the oxibate market.

Mark, Analyst: 1,600 basically. So and you’re saying a few hundred of those. So Luminarize has 2,700 of the 4,000.

Greg, CEO: Right now, Luminarize has over 2,200 riders uniquely to So

Mark, Analyst: 2,200. Yeah.

Greg, CEO: That’s right. That’s right. That’s right. And we’ve added a few hundred kind of new OxoBate riders to the category. Interesting.

Mark, Analyst: Okay. We haven’t talked about the pricing at all. Tom, maybe you can help us with how is the product priced? How is it getting used gross to nets, the average? Just give us a sense of how to think about it.

Where were we going?

Tom, CFO: Yes. So I think maybe the easiest way to think about it is how we reported in 2024. And simple math, we take our revenue and divide it by the patients on therapy. And our average revenue per patient was about $95,000 annualized per year per patient. As we’ve moved into 2025, we took an increase on WACC.

We go through the usual contracted cycle with payers. We’ve always managed to track another point or two out of companies in terms of rebates. But as I think about pricing heading into 2025, I quite frankly expect it to be stable off of 2024 with the potential for some improvement.

Mark, Analyst: But just to be clear, the gross to net will obviously be much higher in the first quarter because they always are for companies, right? So just help us understand that.

Tom, CFO: No, it’s a fair point, and thanks for bringing that up. So it’s yes, we’re certainly not unique in this regard. First quarter for any company like ours, particularly impacted by gross to nets, almost exclusively due to the level of patient assistance we provide to patients who are starting on the product. For the insurance companies that cover them, deductibles are reset to zero. We offset the deductibles.

So it’s a really, really heavy impact on the first quarter. So when you think about the trend, Q1 will always be heavily impacted, which will, of course, impact the calculation of net revenue per patient and then it improves throughout the course of the rest of the year.

Mark, Analyst: I mean, that number could be below 80, for instance, in the first quarter, right?

Tom, CFO: Yes, it’s a really heavy impact. That’s absolutely correct, Mark.

Mark, Analyst: I mean, when you look at the math, it just seems like that’s the only way

Greg, CEO: you get

Mark, Analyst: there, right? And then as the year progresses, you’re saying that you’ll end up on average probably about 95% or you’re saying that the next three quarters will be 95% ish?

Tom, CFO: Yes. I think on average 95 or better.

Mark, Analyst: For the full year? You’ve been including the

Tom, CFO: first quarter? Yes. Excluding the first quarter.

Mark, Analyst: So what was the price increase that you took?

Tom, CFO: We took an 8% increase on WACC, effect oneone.

Mark, Analyst: And Jazz, what did they do 8% to? I can’t remember. Six percent? I can’t remember what they were

Tom, CFO: Yes, they did. I don’t recall exactly.

Mark, Analyst: Yes, it was somewhere in that range though. And so 8%, but you’re basically saying, but all that 8% will be eliminated through

Tom, CFO: It’ll be eliminated. A lot of it will be eliminated through the again, through the deductible resets. And I would say a quick rule of thumb is for every point increase you take on WACC, about half of that probably drops to the bottom line excluding this gross net impact you experienced in Q1.

Mark, Analyst: Right. Talk about inventories. There’s been some movement lately. Just to make sure everybody is level set on that.

Tom, CFO: Yes. I would characterize that during the course of 2024, inventory levels probably moved up and down a little bit as we came out of 2024. And from what we’ve seen so far in the first few months of 2025, inventory levels have remained stable in terms of what we would estimate to be weeks in the channel. So really no impact is what we’re expecting in Q1 from inventory levels.

Mark, Analyst: And for the rest of this year, okay. So we’ve done that. And just as a tag on to the pricing, let’s talk about access and how much you’re working on, where are we on coverage and where do you think we’ll be in a year?

Greg, CEO: Yes. I think from a stepping back and thinking about the mix of patients who are on OXIBATE in any given month or quarter, it’s 82% to 85% commercial. So it’s predominantly commercially insured. I would say most of the next kind of two buckets are split evenly between Medicare and Medicaid, and then a little bit of kind of all other, from that perspective or other government. So predominantly commercial.

Our commercial covered lives now are north of 90%. So we have good coverage policies in place at parity to really all the oxibates from that standpoint, which has been our coverage strategy all along is to not be advantaged or disadvantaged from that matter, but be a parity. On the Medicare side, which again is a smaller piece of it, of the business overall, we’ve seen some improvement in Medicare this year. We’ve had a couple contracts come online in 2025, and I think we’re generally at parity on the Medicare side of the business. And on the Medicaid, which is, again, a smaller percent, we have generally, we have very little coverage only because of the what I’ll describe as the penny pricing of the twice nightly original sodium oxybate.

Mark, Analyst: Let’s talk about your long term goal of this becoming a $1,000,000,000 drug. Walk us through metrics that make perfect sense to everybody. This is how we’re going to get to $1,000,000,000

Greg, CEO: Yes. I think it starts with going back to the patient segments and understanding that you’ve got 14,000 potential switch patients. You’ve got another 14,000 to 15,000 previously treated and discontinued oxoVate patients. And that segment actually grows every year, right, because there are patients discontinuing from the twice nightly oxoVates. And then you’ve got 4,000 to 5,000 patients a year who are starting new.

So if you look at that and say, okay, over the next five years, you know, there’s fifty thousand patients who are potentially in play, of which ninety percent of them are a part of the market that we feel is almost exclusively ours, right, which is Swiss patients and those who have previously treated on it with an oxybate and have discontinued. And we’re sourcing from both of those segments today as well as obviously new to oxybate patients. So from our if you think where we need to be in five years or whatever time frame you think about, we need to be at about 8,000 patients, 8,000 reimbursed patients on therapy, to be able to get to a billion dollars in narcolepsy. Right? And we’re nearly we’re over 20% of the way there now and nearly a quarter of the way there eighteen months into launch.

So for us, there’s a multiple ways for us to get there because we’ve got multiple patient segments to draw from. We could get only all new to oxybate patients and get there. We can get new to oxybate and previously treated and discontinued and get there and never get a single switch. But we’re getting them from all three sources. So we believe there’s ample patient opportunity and ample intervention opportunities for us to continue to grow Loomrise for, for the foreseeable future, with the different patient segments we have to go after.

So I’ll let you add any comments if you have any.

Tom, CFO: No, that’s a very fair summary. Well, let me

Mark, Analyst: just say, if you have over 4,000 if there’s 4,000 new patients that are coming into the market each year, I mean, how are you not getting half of those at least, right? I mean, I would think. So that’s 2,000 a year.

Tom, CFO: That’s right.

Greg, CEO: That’s right.

Mark, Analyst: So if we just went over five

Greg, CEO: years, there’s 10,000 patients.

Mark, Analyst: So how much of those 10,000 can we hold? Like if half of them decide to go off, we’ve kept 5,000.

Greg, CEO: That’s right.

Mark, Analyst: So 5,000 plus the 2,200 we are worth 7,000 right there.

Greg, CEO: You’re close already. Yeah. That’s right.

Mark, Analyst: So it’s fascinating. Let’s talk about in our last few minutes, just the litigation stuff and how you think this is going to play out and the timing. Just remind everybody what’s going on.

Tom, CFO: Yes. Maybe I’ll summarize it this way. There’s really three decisions that we would expect to come out this year. The first is, I’ll say, related idiopathic hypersomnia, where there’s an injunction against us seeking approval from the FDA for that indication. There was an appeals hearing held in February.

Our best guess, if you will, is a decision coming out during Q2. We expect that decision will go in our favor and that injunction will be lifted. Meanwhile, we’re in the midst of a Phase III trial, which we would expect to finish enrollment later this year, second half of this year and get a data readout early next year. So that’s one of the key decisions we expect to come out in 2025. The second key decision relates back to patent litigation ongoing between us and a competitor.

The decision we’re waiting from the judge in that one is just a future royalty rate that may be applied to sales of LumRise. That decision could come any day now. All the briefings and everything were done last year. It’s really just waiting for the judge to decide. So that’s the second decision we’re expecting this year.

And the third decision relates to a lawsuit that we’ve initiated against one of our competitors, an antitrust lawsuit. It’s a jury trial. It’s scheduled to begin November 3. It will go for five days. We would expect a decision pretty quickly after the trial concludes from the jury.

You know, if not the day that the trial concludes, then very shortly thereafter. But maybe I’ll just characterize that as a decision we expect, you know, by mid November of this year.

Mark, Analyst: And just back on the royalty conversation, what just talk about where we are right now and what you think is the most likely scenario?

Tom, CFO: Yes. Where we are right now is I have to refer back to a decision by the jury last year where a 3.5% royalty was determined to be appropriate related to past damages on sales of Luminarize. We view that as a starting point. This is where the judge now has to pick up from where the jury left off. So 3.5% we would view as a starting point.

It’s up to the judge to decide what the ongoing royalty rate may be. The expectation is he may start there, he may end there, he may go a little higher than that.

Mark, Analyst: So should we have 3.5% just in the model right now? Is that a fair

Tom, CFO: Yes, that’s the most recent best information at 3.5%. It’s our operating assumption at the moment.

Mark, Analyst: Yes. And on IH, when are we going to get the data on the IH trial?

Greg, CEO: Yes. I mean the timing is still stays on is still on track to complete enrollment in the second half of this year. And then we would expect data readout top line early part of next year. And then we would be prosecuting toward an NDA filing as soon as possible thereafter, obviously pending this, the court decision that

Mark, Analyst: Right, presuming that that goes well. So if all goes well, you would have that indication in 2027, I suppose.

Greg, CEO: That’s a fair estimation right now.

Mark, Analyst: And just lastly, help us understand how much that changes your thought process of the product and the opportunity.

Greg, CEO: Well, it adds another forty thousand potential plus eligible patients who are diagnosed with, with idiopathic hypersomnia in the marketplace. It’s a very unique patient population from what we hear from physicians, primarily because where narcolepsy is a condition where people suffering from it have a hard time staying awake, people who suffer from idiopathic hypersomnia have a hard time waking up. And we hear all the time from physicians that as much as they like our value proposition of LumRise and narcolepsy, many feel it’s even more compelling in idiopathic hypersomnia because of the inability for patients to potentially wake up to take the second dose. So we’re excited about those prospects and continuing to grow the launch and build on the momentum we’ve created in the first quarter.

Mark, Analyst: Thank you. Thanks, guys, for joining.

Greg, CEO: Thank you.

Mark, Analyst: Good luck this year. Yes. Thank you.

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