Avadel Pharmaceuticals at Jefferies Conference: Strategic Growth and Challenges

On Thursday, 05 June 2025, Avadel Pharmaceuticals (NASDAQ:AVDL) presented at the Jefferies Global Healthcare Conference 2025, highlighting its strategic shift from a generic hospital business to a high-growth biopharmaceutical company. The company’s lead product, LUMRIZE, is driving significant market penetration in treating hypersomnia and narcolepsy. While Avadel reports positive financial trends, it faces challenges, including ongoing litigation.

Key Takeaways

• Avadel is focusing on LUMRIZE as its lead product, targeting market leadership in narcolepsy.
• The company achieved a 50% growth in net patient additions in Q1 2025 compared to Q4 2024.
• Positive financial indicators include three consecutive quarters of adjusted positive operating income.
• Avadel is pursuing an antitrust lawsuit seeking over $1 billion in damages.
• LUMRIZE has received orphan drug designation for idiopathic hypersomnia from the FDA.

Financial Results

• Positive Indicators:

- Avadel reported its third consecutive quarter of adjusted positive operating income.

- Operating expenses decreased by 3% year-over-year from Q1 2024 to Q1 2025.

- As of March 31, 2,800 total patients were on therapy, with over 2,000 reimbursed.

• Revenue Guidance:

- Q2 revenue is expected to be between $61 million and $63 million.

• Gross to Net:

- The company anticipates improvements in gross to net adjustments in Q2 and Q3.

• Inventory:

- Inventory levels stabilized at approximately three weeks in the channel at the end of Q1.

Operational Updates

• Launch Performance:

- Avadel describes its launch execution as "proud but not satisfied," with room for improvement.

- Consistent growth in new prescribers and patients, including those new to oxybates.

• Real-World Evidence:

- Data shows significant clinical benefits for patients switching from first-generation oxybates to LUMRIZE.

• Patient Segments:

- Avadel sources patients from those on twice-nightly oxybates, those who discontinued them, and new-to-oxybate patients.

- Switch patients experienced accelerated growth in Q1, reversing previous trends.

Future Outlook

• Key Milestones:

- Completion of enrollment in the Phase 3 trial for LUMRIZE in idiopathic hypersomnia by year-end.

- Trial results expected in early 2026, followed by an NDA filing.

• Orphan Drug Designation:

- LUMRIZE received orphan drug designation for idiopathic hypersomnia.

- The company aims for orphan exclusivity based on clinical superiority.

• Market Potential:

- Avadel estimates a total addressable market of 50,000 potential patients for LUMRIZE.

• Litigation:

- An antitrust jury trial is scheduled for November, seeking over $1 billion in damages.

Q&A Highlights

• Orphan Drug Designation:

- Avadel submitted data to the FDA emphasizing the importance of addressing difficulty waking up in idiopathic hypersomnia.

• Switch Patients:

- The number of switch patients increased in Q1 and Q2.

• Discontinuation Rates:

- LUMRIZE shows better discontinuation rates compared to first-generation oxybates.

• Litigation:

- Avadel won an appeal in the idiopathic hypersomnia case, allowing further clinical trials.

Readers are encouraged to refer to the full transcript for more detailed insights.

Full transcript - Jefferies Global Healthcare Conference 2025:

Andrew Tsai, Senior Biotech Analyst, Jefferies: Okay. Alright. We’re gonna get started in our next session. I’m Andrew Tsai, senior biotech analyst at Jefferies. Thanks for tuning in.

It’s my pleasure to have the AVID all team. To my direct right is Greg Divis, CEO. To his right, Tom McHugh, CFO, and to his right, Susan, I believe I’m sorry. I missed your last name.

Greg Divis, CEO, Avadel: Rodriguez.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Rodriguez. Yes. Chief Commercial Officer?

Tom McHugh, CFO, Avadel: Chief Operating Officer.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Chief Operating Officer. Thank you for joining us today. So maybe spend the next couple minutes talking about the Avadel story and walk us through milestones. That’d be great.

Greg Divis, CEO, Avadel: Yeah. First of all, thanks, Andrew, for the opportunity to be here and to participate in the conference. We really, really, really appreciate it. Avadel is a really Loomrise is a transformational story. Over the last five years, the company has really transformed itself from what was once a generic hospital business to now a high growth biopharmaceutical company with a lead program with LUMRIZE as our first commercially launched product, a next generation, highly positively disruptive standard of care for patients who suffer from hypersomnia, and specifically narcolepsy.

We’ve been in the market now for two years and have made tremendous progress, which I’m sure we’ll talk about from that perspective, and are working on what’s next for us as well from a lifecycle management and pipeline expansion standpoint off the back of Lumerize and the innovation of our next generation oxybate. From a milestone perspective, I would say over the next for the balance of this year, there’s a couple of things for sure that are really, really important. Number one is obviously our launch and the continued growth in adding NET patients and building our revenue and continuing our pursuit to market leadership over the next number of years in narcolepsy, obviously first and foremost as our priority in terms of measuring our results quarter in and quarter out from that perspective. In addition to that, we’re in deep into our phase three trial for LUMRIZE in idiopathic hypersomnia. So we do expect this year, by the end of this year, to complete enrollment in that trial, to have readout of that trial in the first part of next year, and begin our process and progress toward filing an NDA.

In this regard, just last night, we received from FDA notification that LUMRIZE for idiopathic hypersomnia has been granted orphan drug designation, which is an important first step, in the regulatory and potential approval process to be granted eventually orphan exclusivity, much like we’ve had already occur on two different occasions in narcolepsy, for for for lumirides in patients, in adult patients with narcolepsy, and subsequently pediatric patients in narcolepsy. So this is the third time that the FDA has weighed in, recognizing the novel and innovation of LUMRIZE, as a a a as awarding it orphan drug, in this case, designation under the basis that it’s a major contribution to patient care and under the consideration of granting it clinical superiority.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Congratulations. Thank you. On that front, I’m actually curious before we dig into the launch actually, how what did you give the FDA in terms of the data for them to even give you an ODD?

Greg Divis, CEO, Avadel: Well, we obviously have a number of different data points and data sets that have been supportive both in narcolepsy additional data and research that we conducted subsequent to that relative specifically to IH and the importance of a condition where, unlike narcolepsy that is primarily characterized by patients and people with narcolepsy having trouble staying awake. Idiopathic hypersomnia is one where patients have a hard time waking up. Right? And the notion of having to forcibly awaken to take a middle of the night dose can be challenging for sure, at least what we hear from clinicians. And the value proposition from a clinical clinician’s perspective for lumirides is quite high for idiopathic hypersomnia and they’re quite interested in it.

We’ve taken a lot of those insights and a lot of the research and compiled our requisite submission for the basis of granting, Lumeri’s orphan drug designation, and we’ll continue to build that body of evidence between now and our approval when we submit for full approval in orphan exclusivity. And, again, I think we feel really good about the fact that we have two of those. We’ve been through this process now twice with FDA, and and in both times, we’ve ended up with with full orphan exclusivity.

Andrew Tsai, Senior Biotech Analyst, Jefferies: I see. I’m debating whether to ask more or go back to the launch. Maybe one more question is, do you then foresee Jazz to try to block you somehow with this new designation or, you know, litigate against the FDA actually? I think that’s what happened last time.

Greg Divis, CEO, Avadel: Well, that’s a better question for them.

Andrew Tsai, Senior Biotech Analyst, Jefferies: I see. But ultimately, the goal is generate your phase three data with this with Lumerize in early twenty twenty six, file, get it approved. And with this ODD, it is it’s my understanding that maybe the FDA gives you an orphan drug exclusivity and removes it from Xywav potentially for IH?

Greg Divis, CEO, Avadel: Yeah. It’s not necessarily removing it from from an existing orphan exclusivity. It’s it’s it’s demonstrating clinical superiority through the guidance of what orphan the Orphan Drug Act requires to demonstrate, you you know, clinical superiority. And we’ve demonstrated that enough in our submission to be granted designation. Mhmm.

And and that will have to be evaluated, confirmed upon the full approval, much like that happened in narcolepsy, right, both in adults and pediatrics. We got designation, and then subsequent with our NDA filing and and approval, we were granted orphan exclusivity on the basis that Lumeri’s deemed was deemed to be clinically superior on its major contribution to patient care.

Andrew Tsai, Senior Biotech Analyst, Jefferies: I see. So somewhat of a tried and true pathway in a sense. Okay. And so going back to the launch, again, congratulations on that. You’ve launched Loomerais since June of twenty twenty three.

How would you rate your execution over the past two years? And what would you say are the key drivers for continued uptake in 2025?

Greg Divis, CEO, Avadel: Yeah. I mean, we’re two years into the launch now. There’s been a tremendous amount of learnings, and there’s a lot of different ways we can characterize the execution. We’re very proud of the progress we’ve made going from a few years ago just having 25 or 30 employees to now having a fully launched and commercial organization that has made really significant inroads into the market with a lot more opportunity to be had. So we’re proud but not satisfied.

That’s kind of how I would describe it, with a lot more to be done for sure. You can measure progress in a lot of different ways, but there hasn’t been a quarter, a month, a quarter, or a year that has gone by where we haven’t gained new prescribers, added more patients, brought in new physicians who’ve never written an oxybate before. All of these are very promising indicators to the interest in Lumerize as the next generation oxybate and really elevating the standard of care for patients who are eligible and need to be on oxybate. We’re the only oxybate that can assure that that patient every night is getting its full treatment every single night consistently delivered night after night after night. And we believe over time that will ultimately portend to patient benefits in terms of not just having to wake up in the middle of the night, but ideally, in terms of improving their treatment, experience from that standpoint.

We’re presenting data next week at the sleep meeting that we’ve completed a real world evidence study where we switch patients from first generation oxybates to Lumerize. And and as what what has been reported and will be reported next week was patients experience a significant clinical benefit in terms of improving their daytime sleepiness and improving their ESS scores. So again, in the real world, which what matters now is we’re seeing really good results from that perspective. And so we’ve continued to execute with a lot more to go from that standpoint. The drivers of that are really straightforward.

And we think about that in three buckets. We think about it as how do you drive demand kind of at the top of the funnel? How do you pull through those patients faster and at a higher reimbursed rate you know, once they’re going through the process, and then how do you keep them on therapy. We’ve talked ad nauseam about the investments we’ve made effective January 1 to positively impact all three of those steps along the journey, and we’ve seen progress in all three of those areas. In Q1, as we’ve noted, we saw more patient starts.

We saw an improvement and an acceleration of switch patients. So all very positive signs. We saw patients start faster. We saw higher reimbursed rate patients go on therapy. And the net effect of that, you know, with the positive trends in our persistency efforts, we we added we had a 50% growth in net patient adds in q one over over q four of twenty twenty four.

So again, these are the major drivers. These are the areas where we continue to focus on. We continue to learn and improve and and make the right adjustments, and we’ll continue to do that as we go forward as we’re very as we’re still very early in the launch.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Great. Thanks. And remind us what is the total addressable market in terms of number of patients for an oxidate like LUMRIZE? And also remind us how many patients do you need to break even? Are you there yet?

Greg Divis, CEO, Avadel: Yeah. It’s it’s one of the very unique opportunities for Lumerize and and and and the innovation that is Lumerize in that where we are sourcing patients and the market opportunity for which we can draw patients into our program is very different than that of the other oxybates. Because we have what we think upwards of 50,000 potential patients who could be on lumrise that come from three primary sources. About 14,000 patients based on the data we can analyze who are currently on a twice nightly oxybate of some sort. And then you’ve got another excuse me, 14 thousand to 15,000 patients based on historical, claims data who have been on an oxybate and previously discontinued.

And then, of course, you have, every year, anywhere from three, four, five thousand patients who are starting new, truly new de novo to oxybate each and every every year. And those three, over the next number of years, creates a large patient population for us to draw patients from. And and every quarter since launch, just like we’ve added more prescribers, more patients, and prescribers who’ve never written oxybate, we are adding patients from each one of those segments every single quarter since launch. Again, all very positive signs and all reflection of what we think is the innovation and, you know, that is the next generation oxybate in Loom in Loomrise. Mhmm.

In terms of your question about breakeven, you know, Tom can maybe provide more specifics. But in short, yes, we’ve reached a critical mass of patients on therapy that every patient we add from this point going forward get, you know, and obviously, the more that are reimbursed, the better, should ultimately drop to the bottom line. Our cost structure is is for all practical purposes built, and any changes to that, you know, up or down would be, you know, relatively immaterial on a percentage basis. So we feel we’re well built from an infrastructure standpoint. We’ll always look for ways to invest to grow the launch and improve our performance from that standpoint.

But we’re really pleased that where we’re at at this point and the and the efficiency of our cost structure to drive, you know, free cash flow.

Tom McHugh, CFO, Avadel: Yeah. In fact, Andrew, when we reported our q one results just a few weeks ago, it represented our third consecutive quarter of adjusted operating income and adjusted positive operating income, which is simply a function of just backing off non cash operating expenses. So to Greg’s point, it’s a high leverage of cost structure, you know, as a reference point, year over year, q one of twenty four versus q one of twenty twenty five, our operating expenses actually went down 3% at the same time while we’re driving patient growth and revenue growth. So it’s a really, really highly leverageable cost structure and every patient is important. Greg just described the, you know, the patient segments, you know, the sources of business for for Lumerize And every patient is important.

So but every patient we’re adding at this point only drives us further and further above and beyond break even.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And how many patients do you think you need to hit to maintain break even? What is that range?

Tom McHugh, CFO, Avadel: So we’re effectively there. So we reported two thousand eight hundred patients, total patients on therapy, you know, as of March 31, over two thousand of whom were reimbursed.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Got it. Got it. Thanks. And what is your percentage mix between the three, amongst the three sub segments today? And how do you foresee that mix to evolve over time?

Greg Divis, CEO, Avadel: Well, I think this is an important point. As we reported, yeah, you know, some of the q four results where we saw this the percentage of patients between the switch return to oxybate and naive new to oxybate patients, you saw over the course of 2024, the the the percentage of switch patients trend down, and the the the percentage of the other two categories go up, in particular, new to oxybate. In q four in ’1 this year, we’ve seen that trend reverse. Right? We not only grew patient starts, we actually accelerated the pace of switch patients, And switch patients have grown up grown from that that those percentages and are at a higher percentage in q one.

And and those that trend generally has continued through q two. So, again, I think through the the changes we’ve made, the the team members we’ve added, the programs we’ve initiated, and the focus we’ve we’ve we’ve had, we’ve been able to, you know, see positive trends and momentum in that regard.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Great. And I I guess I to me, the switch in naive patient populations seem to drive much of your mix. The former oxybate users, there’s a big population. I think you mentioned maybe 15,000 or more out there, but they don’t seem to be a greater percentage of your mix. So at its core, why is that the case?

Is it because fundamentally, they’ve already it is a I mean, both of your drugs, yours and Jazz, are oxybate. So hence, maybe they dropped out due to lack of efficacy safety. But then what I can think of is maybe they dropped out due to once nightly dosing. So my question is, what proportion of that fifteen thousand truly did drop out because of the once nightly factor that would be truly amenable to your pro your drug?

Greg Divis, CEO, Avadel: Yeah. You can get macro commentary and macro research to help give you some general guidance. But at the end at the most what’s most important is what happens between the physician and the patient. And this is a large patient population. And the most important, you know, thing for us in this regard is that over ninety plus percent of those patients are still under care by the same physicians we’re targeting today.

So we have seen, like all of our other metrics, every month, every quarter, you know, twenty, twenty five percent and some months higher of our patients starts coming from this segment. Right? So this is a real segment for us it’s a segment we’ll continue to target. And with the discontinuations that occur with the twice nightly patients, it’s a segment that continues to repopulate itself from that perspective. So we think it’s going to be there for quite some time, and that opportunity will only continue to grow as we amass more patients and there’s more patient experience and more patient commentary about coming back in.

Some of those have come back in who had problems with the middle of night dosing. Some have come back in who had adverse event or efficacy related matters. So we’ve gotten all sorts from that perspective, but what’s most important is that they’re still under care by the same clinicians, and we’re targeting them and believe over time we can continue to build this group of potential LUMRIZE patients who can benefit from our innovation.

Tom McHugh, CFO, Avadel: Yeah. And maybe I’ll just add to that, Andrew. It’s a patient segment that we would view as exclusively to the benefit of Lumerize since they have previously tried and discontinued on a twice nightly for whatever reason it may be. The logical choice, of course, is a once nightly option that and the benefits Lumerize ops offers. So it’s it’s a it’s a large segment.

We continuously size it about 15,000 patients. But again, exclusively to the benefit of Lumerize.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Good point. And within the naive patient population for, let’s just say, every 10 new patients that go to an oxybate, what’s the proportion of those patients going to LUMRIZE versus Jazz’s products right now?

Greg Divis, CEO, Avadel: Yeah, think it’s hard to really understand that because the data’s just not available by and large. But what we can say from what we can see, we continue to grow our share penetration in that segment. And in particular, when we look at our penetration of new to brand, in particular to our early adopters, we’ve gathered or garnered a significant amount of share in the new to brand patient population while our total total share has grown quite nicely in our early adopters. But that that represents a, you know, a large portion of our volume launch to date, and now we’re expanding that to the to the broader universe, which is really propelling some of our positive trends here in the first part of twenty twenty five.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Got it. And then one more within this subpopulation because it is ultimately one of the key drivers of your growth is to blunt dropout rates Mhmm. For de novo patients. My understanding is even for your pay set of patients new to oxybate, the discontinuation rates can trend closer to what Jazz had been seeing, which is maybe closer to fifty percent. But you are doing market education efforts.

So where do you think with with improved marketing or education efforts, where do you think the discontinuation rates can ultimately go to?

Greg Divis, CEO, Avadel: Yeah. Well, to be really clear, so to to to to state something that at all time points on patients, LUMRI’s shows a better discontinuation rate versus first generation oxybates. Right? And a lot of that was occurring before we implemented all of our interventions, which went effect in January first of this year, where we’ve expanded our field support teams. We expanded our nurse teams.

We’ve developed and are delivering a much more comprehensive patient support initiative, not just getting patients on therapy, but helping them navigate through the treatment experience, especially those early in the treatment experience, and especially those who are new to oxybate, because those are the patients who have the largest jump from having zero oxybate exposure to four and a half grams as the starting dose. And that’s where you see the most adverse events. We’re very, very pleased and and really excited about the progress we’ve made on that front just in the first four or five months of this year. And and what we thought may take us a little while to have an impact, we saw that impact immediately in q one, and we saw a decrease in our, a pretty meaningful decrease in our discontinuation rates, in particular, new to oxybate patients, and in particular, in the first thirty, sixty, ninety days of therapy during the first during the first, quarter of this year. And that momentum has carried on in Q2 where we saw our how we calculate discontinuation rate inside of a quarter, we saw it improve in Q1, and it’s continued to improve in Q2.

So these are all positive signs that demonstrate that the the the decisions we made, the investments we made, the initiatives we’re deploying were all the right ones. We just have to continue to execute. To your question is where’s the floor? I don’t have an answer to that right now because we haven’t hit it, but we’re gonna try to make it as low as it possibly can be, and we’re working on things we can do to make it even better as we go forward.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Great. Thank you. And for first quarter, you didn’t necessarily provide color on the number of patients who had initiated therapy, although you previously have guided to where you want to be by year end. Can you confirm that the pace of additions in Q1 were similar to fourth quarter? There was no deceleration, but rather continued growth.

Greg Divis, CEO, Avadel: Yeah. We can confirm that we we started more patients in q one than we did in q four, and we had growth from all patient types, all patient segments with the acceleration in switch the greatest.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And we’re two months in into q two. Can you then also confirm you’re getting continued growth, if not more?

Greg Divis, CEO, Avadel: Yeah. I think the momentum and the initiatives we deployed in q one that began to take effect, we’re seeing that carry on in q two.

Tom McHugh, CFO, Avadel: Yes, specifically Andrew, we were provided guidance for Q2 revenue in the range of $6,163,000,000 dollars We’re very confident in that of course, we have very clear line of sight to achieving that. And as Greg has noted, you know, the metrics that, you know, drive whether it be patient growth, drive revenue, we continue to see improvement across metrics.

Greg Divis, CEO, Avadel: And ultimately, I’m sorry, but ultimately the most important metric is net patient adds, Net patient adds and reimbursed net patient adds are really most important.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And speaking of net patient adds, we did hit a low point in fourth quarter and seemed to bounce back to your point about blunt and discontinuations. It did bounce back a little bit about Q1. You know, one, two, three, four, five years down the road, is it fair to assume Q4 was the trough quarter for Loom Rice?

Greg Divis, CEO, Avadel: Well, q four was a growth quarter. Our versus, you know, a, we added more patients than what we had before. But but at the end of the day, our goal is to add as many as we can. Right? So we wanna keep growing where we are from where we are today, and that is ultimately the goal.

And and what makes Lumerize unique from a market opportunity perspective and a and a share perspective and a and a and and a penetration perspective is we’re sourcing patients from a much larger patient population than the other oxybates. They’re primarily competing in the new to oxybate segment only, which is three, four, five thousand patients in a given year, depending upon the year. We that’s 10% of the market opportunity that we’re pursuing right now. So we think the avenues to continue to grow now and into the future is quite robust.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Great. And gross to net inventory for Q2, how should we think about that?

Tom McHugh, CFO, Avadel: Well, Q1 is always impacted by gross to net. It’s always the highest quarter that gets impacted with gross to net. What we’re expect to see is an improvement in gross to net as we’re into Q2 and then certainly into Q3 as well. Inventory levels, I would say have stabilized, right? It’s our expect we ended with about three weeks of inventory in the channel at at the end of q one.

We’re seeing those continuing levels as we go through, you know, continue through q two.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Great. And then Orexin’s, we’re going to have a lot of data sets this year. And what is your latest stance on Orexens? Why LuminRise ultimately will not be affected by quote unquote competition?

Greg Divis, CEO, Avadel: Yeah. I mean, clearly, the investment community is very excited about the prospects of of orexins and the wakefulness aspects of what those drugs can do. What we’re most concerned about is what physicians and clinicians think. So we spend a lot of time and invest a lot of energy with not only key opinion leaders who are the experts in this space, but also the clinicians in the field who see a lot of patients trying to understand where they view orexins, how they view oxybates, and in particular how they view lumirize, and how that may all come together over the next number of years. And I think most importantly, lumirize is setting a new standard of care for oxybates and the benefits that oxybates can deliver, which is not just a daytime benefit, right?

We remind everyone that narcolepsy has a pentad of symptoms, right? Excessive daytime sleepiness is one of them, but so is hallucinations, so is sleep paralysis, so is disturbed, disrupted nocturnal sleep that affects a lot of patients. These are things that oxybates do very, very well, and very few people, if any, go on oxybates who are already on a weight promoting agent because it’s a polypharmacy situation. I think our view and our research talking to hundreds of physicians is that there’s excitement about what the wakefulness aspects of it, of an orexin, and what that may do to not only benefit patients but expand the treated patient population. But in no case have we heard from anyone that the role of oxybates in the world they play in terms of treating, you know, both the daytime and the nighttime is going to go away.

They’re gonna play an important role. And the ideal the ideal combination therapy in the eyes of of clinicians is can they be on an orexin and on an oxybate? Because you deal with you get the profound weight promoting aspects as well as, obviously, the benefits of the nighttime that an oxybates that oxybates, and in in our case, Lumerize Lumerize delivers. But I think there’s also equally just general excitement about the the wakefulness aspects and cautious about, like, what will it how will it play out? What will be the adverse events over time?

What will be what will what will an orexin look like in the real world from that standpoint? And what impact, if any, will that have on the nighttime? Right? Good or bad. But we do think that that, based upon our research with physicians, there’s an important role for oxybates.

There will continue to be, and we’re proud to bring the next generation and continue to work to bring innovation to this to this category for oxybates to really help patients both address the daytime and the nighttime.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Great. And maybe the last few minutes, maybe to spend some time on the litigations, many litigations you’ve had because it is another piece to the story. But you’ve actually, you know, prevailed in many of these cases along the way. Long story short is what can we expect in 2025 in terms of news flow across these cases?

Greg Divis, CEO, Avadel: Well, I think the most important no. Not the most important, but one one important thing to highlight was a decision last week. And we’ll talk about the the the antitrust case here in a minute. But, you know, there’s been efforts made to try to, you know, stay that decision or get it dismissed. And last week, the court again determined that that that that hearing that that that jury trial will occur, will go forward.

Avadel was is due its day in court the November in a jury trial where we are asserting that we were wrongfully delayed into the market because of a wrongfully listed patent in the Orange Book. And as we said on our last call, that we will be seeking total recovery in excess of $1,000,000,000 because of that delay. So that is on track. That is a November 4 or fifth or third or the first week, right, when that five day jury trial commences. In addition to that, there will continue to be the follow on outcomes of past litigations that have had some decisions in this regard.

There will, at some point, be a decision what a future royalty rate will be. There will be post trial motions on the patent litigation, which we’ll continue to pursue our opportunities to invalidate the one patent that we think the jury got wrong. But nonetheless, I would characterize where we are today as a lot of the pivotal decisions have been made. We’re moving forward. Loomrise is in the market.

Loomrise is advancing in IH from a clinical trial perspective. And we’re now for us, we’re now, I would say, going more on the offense. Right? Whether it’s the antitrust case or the four patents cases, suits that we filed this year against Jazz, noting that they’re infringing our intellectual property with their IH label. Those are the things that we’ll continue to proceed.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And you recently won an appeal in IH. And what is the latest status on that? Can you remind me?

Greg Divis, CEO, Avadel: Yeah. That decision, which came down a little while ago, a few weeks ago, basically overturned the decision to preclude us from doing any more clinical trials and vacated the decision to allow us to proceed and seek seek approval. Right? So that’s where that is at this stage. I’m sure there’ll be additional follow-up and litigation in the district court around this matter.

But it’s also one of the reasons why the decision yesterday to grant this orphan drug designation is another important you know, step in the process where the FDA is saying, you know, based on what we see right now, it’s plausible that LUMRIZE could be granted orphan exclusivity on the basis of its major contribution to patient care just like they’ve done on two previous occasions.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Right. Okay. I think that’s all the time we have, but thanks for the updates. Look look forward to more.

Tom McHugh, CFO, Avadel: Thank you. Thank you, Andrew.

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