Avadel Pharmaceuticals plc (AVDL) Earnings Call Transcript & Summary

Welcome to Morgan Stanley Global Healthcare Conference. I'm Sean Laaman, Head of U.S. mid-cap biotech Equity Research here at the firm. Before we begin, research disclosure website at www.morganstanley.com/researchdisclosures. And if you have any questions, please reach out to your Morgan Stanley sales representative. For this session, we have Avadel. We have CEO, Greg Divis; CFO, Tom McHugh; and COO, Susan Rodriguez. So welcome to the 3 of you. Before we commence the broader Q&A, maybe if we could get a high-level view of Avadel.

Yes. First of all, thanks for having us here and the opportunity to participate in your conference. It's much appreciated. Avadel is a growing biotech company that has really transformed itself in the last 5-plus years. We're now in our ninth quarter of our launch of LUMRYZ, a first and only once-at-bedtime oxybate for the treatment of narcolepsy for patients suffering from EDS and cataplexy, both adults and pediatrics. But it's a very dynamic and exciting time for us right now as we just -- we're in the middle of our ninth quarter of continuing adding more patients and growing our business and growing prescribers with over 3,100 patients on LUMRYZ. We've moved into the cash flow positive state as a commercial stage organization. We're in the back end of our pivotal Phase III trial for an indication expansion in idiopathic hypersomnia, which we expect to complete enrollment by the end of this year. And just last week, we announced an acquisition, a licensing deal for a new program to expand our oxybate portfolio with a development stage compound called [indiscernible] oxybate. So there's a lot of catalysts, a lot of milestones and a lot of great momentum going on with the business today.

Awesome. That's a great jumping off point. I've got some macro considerations for you. So with China's rise in biotech innovation, how are you thinking about the competitive position here for Avadel and will this influence your R&D and business development strategy?

Well, I think for us and the spaces where we're focused in the therapeutic areas and where we're of greatest interest, we search the globe for opportunities. And from that perspective, we look for places and opportunities and programs that could bolster our portfolio and address the unmet needs of patients who we're trying to serve every day. So for us, geographic location is less important than finding the right sort of novel innovative developments that can truly make a difference in patients and help continue to build our business much like the transaction we announced last week, which was with an Asian company. So we certainly are searching everywhere for those opportunities.

Wonderful. And are you leveraging AI as part of your business strategy? And how do you think about AI as a potential disruptive force?

Well, I think today, it's the price of entry in many ways, right? And for us, you're always looking for ways where we can deploy AI or breakthrough disruptive technologies to advance our business, in all aspects of our business, whether that's commercially from an analytics standpoint, we have reams of data within our ecosystem that enables us to deploy large language learning models to be more predictive in what may occur in the future to deploy the right intervention at the right time to serve the patient or whichever stakeholder in the best possible way. But it's really across all aspects of our business, be it clinical, commercial, manufacturing, quality, CMC. It's here to stay, and we're probably just scratching the surface.

And on the regulatory side, a lot of discussion in biotech on FDA, MFN tariffs. Anything that you'd like to call out there?

Yes, it's something we obviously pay close attention to taking those in some order. From an FDA perspective, our engagement has been quite productive and responsive and on time. We had an orphan drug designation for our idiopathic hypersomnia indication, which was on time. Our engagement with the FDA has been quite responsive and productive, both telephonically in writing and in-person meetings. So from an FDA perspective, we haven't seen any issues. From an MFN standpoint, our business is really in the U.S. So LUMRYZ is not available ex U.S. So there's real no issues for us relative to MFN. And from a tariff perspective, over 4 years ago, we began the process to onshore our manufacturing to the U.S. where we could serve all of our customers and all of our patients through a domestic -- solely domestic source, which gave us both the benefit of redundancy in our supply chain going back 4 years ago, but also the benefit to source all of our API from the domestic sources here in the U.S.

Great answer. Starting with LUMRYZ, can you give us an overview of the narcolepsy treatment landscape, gives the differentiation of pathologists between NT1, NT2 and IH and maybe how you size the patient populations in those baskets?

Yes. So overall, we estimate there are about 160,000 patients suffering from narcolepsy, of which about 80% of them are on treatment. Majority of them are on wake-promoting agents for the daytime symptoms that they're experiencing, excessive sleepiness. About 2/3 of the patients actually also suffer from nighttime symptoms, and that's where these patients then need additional therapy. We estimate that around 50,000 patients are eligible for oxybate therapy, of which within that context, so that would be our total available market at this time for LUMRYZ, which around 15,000 are currently on an older oxybate on therapy, around 15,000 are previously discontinued. And the remainder are potential new to oxybate patients, which is about 25,000 patients, which we see, on average, 4,000 to 5,000 new patients starting oxybate therapy every year. So this is the total available market for LUMRYZ. And what we're finding in terms of the opportunity for LUMRYZ is that as we grow our writer base and they advance through the adoption cycle, we're sourcing from all of those patient segments.

And I guess just to hone in on oxybate and promotion of the healthy sleep architecture. Can you talk through that and how it compares to other therapies?

Yes. So as I mentioned, 2/3 of narcolepsy patients experience nighttime symptoms, and this is disruptive nighttime sleep, hallucinations. The big promoting agents really do not address these nighttime symptoms. And that's where, as a 24-hour condition, narcolepsy, what you see with oxybate, which is highly differentiated is that not only do they address those nighttime symptoms and promote healthy sleep architecture, but they also are associated with very high levels of daytime efficacy. So 24-hour condition, nighttime and daytime effects of oxybate.

I think it's one of the things that makes LUMRYZ so unique is that it's really the only treatment today that doesn't disrupt the night. It actually improves the night. Wake-promoting agents or twice-nightly oxybate either insomnia or forcibly awaken someone to take a dose in the middle of the night, but LUMRYZ doesn't require that to happen. So in a 24-hour condition, as Susan noted, between daytime and nighttime, the LUMRYZ value proposition and in the future, the low oxybate value proposition is quite compelling.

Sure, sure. It sounds like it. Maybe just to move on to the XWPharma series of questions. So you recently announced the pipeline vision with valiloxybate. Can you walk us through your decision to add to your pipeline and how this is aligned with your overall vision for the sleep space?

Yes. I think first and foremost, it is very strategic for us in terms of where we are today and the incredibly strong foundation we have built in the rare sleep disorder space with LUMRYZ and what we've been able to do. We are very bullish and believe that the future of oxybate use is migrating to extended-release oxybate. And that's what LUMRYZ is the real first extended-release innovation to the oxybate category from that standpoint. So being able to add to that foundation with oxybate is something that was quite attractive to us. And when you think about it, we're not doing this at the end of the life of our product where I'm trying to extend -- we're trying to extend the tail to kind of an end-of-life life cycle management strategy. This is a portfolio strategy that's happening at the beginning of the life of LUMRYZ to build a portfolio of extended-release oxybate that can address all the needs for all patients and provide the opportunity to treat more patients with an Avadel oxybate. So strategically, it makes great sense from that standpoint. And then if you then think about the development pathway forward, it's highly capital efficient from a development standpoint. It's highly time efficient from a clinical standpoint and from a regulatory standpoint. So it really checks all the boxes for us in terms of a strategic fit and really works well in terms of where the company is today and provides a significant opportunity for patients as well as for our company and, of course, our shareholders.

Sure. Can you talk a little bit about working with XWPharma, a bit of familiarity with the business, how you came across this opportunity, give investors a bit of a sense about the genesis of the relationship.

Yes. To cover that, I kind of go back maybe 4.5-plus years ago, when we first reached out to them to talk about a potential collaboration, and there was a different management team at that time with the company, and there wasn't interest to want to collaborate at that point. So we proceeded forward with our business, including beginning to do our own development work on our own in-house novel formulations to potentially develop a once -- extended release, once-at-bedtime, low or no sodium oxybate. And as we went through that process, and I would describe it in 2 phases, we did a lot of development in terms of trying -- starting with sodium oxybate, the original API and modifying it inside of our manufacturing process. And over time, we decided to add a different pathway, which was to start developing a novel API. So starting with a novel stable API gave us a lot more of an ability to modify that API from a release profile over time. So as we began that pathway, it took us back to XW. There were some new people there. And that is really where the genesis of the discussion picked up. And I would say the best thing about the last number of months of our due diligence is that we've been able to spend some time not only looking at all of the data they've generated in-house and get very comfortable with what they've developed, but also all of their interactions with the FDA. And we even had, for the last couple of months, an opportunity to get our hands on their product and do a little work with it and see how it's made and see how it works, which the combination of all those things gave us a lot of conviction in terms of the high probability of success by entering into this partnership that now we're entered into and we're off and running.

Great. Great. And what are the next steps for the asset? What's the next steps for the regulatory piece and open up the market?

Yes. The way we see that moving forward is the next step for us is what we'll characterize as our initial PK study and our initial PK work. which will begin a little later this year. There's some steps we have to take, make some clinical trial supply and whatnot. But that should begin by the end of this year and carry on into Q1 of next year. And our expectation is -- and our goal and our target is to have our final formulation by the end of Q1, which will then put us on really 2 paths. The first path is then to take that formulation and make our registration batches, which will both supply our registration pivotal PK trial as well as begin to prepare for our NDA. And then in parallel, we'll engage with the FDA, looking at all the previous correspondence between FDA and XW to then map out our course to run our registrational pivotal PK trial, which will take us a bit of time. And by the time that product comes off at 12 months of stability, our target is to be in a position sometime in 2027 to file this NDA.

Wonderful. And maybe finish this line of question just by talking through some of the deal economics.

Yes. It's -- not only was the product and where it fit in this development and how synergistic it was and strategic it was for our business, the deal structure was equally as compelling for us because the team at XW is firmly believes of the potential of oxybate longer term. And our goal was to want to do this deal off our balance sheet. So it is -- we'll pay what amounts to $20 million in upfront investments to acquire the rights. There is $30 million in success-based clinical development milestones that tied to key milestones heading toward a potential NDA approval. And then everything else is commercially post-approval commercial back-end milestones that are obviously highly attractive as the more successful the product can become. But we believe in all of our research with physicians since we just finished a large project, researching this with physicians and the possibility of LUMRYZ and valiloxybate certainly should be the oxybate portfolio of choice and valiloxybate's product profile in and of itself is quite compelling for prescribers.

Interesting. Maybe on to LUMRYZ. So you've recently raised guidance $265 million to $275 million for the year. I think you had 3,100 patients on drug at the end of 2Q. So maybe talk through some of the planks of the raised guidance and what underpins your confidence that you're going to hit that number.

Well, I think let's start with just what's happening inside the business and from a demand and all the key attributes and maybe Susan, you can cover that.

Yes, sure. So it's really our confidence in the underlying growth drivers that have propelled us to that 3,100 patient number. First, we have significant penetration across the writer base. 1,600 writers account for 80% of total oxybate use, and we actually have them writing LUMRYZ very early in the launch. Now that we're 9 quarters post launch, we have an opportunity to track their writing longitudinally. And what we see is quite consistent that they adopt LUMRYZ for what they see as their problem patients early on, and we're waiting for a better solution for the patients who are not doing well on the older therapies based on the results that they saw in that first bolus of patients where they switch them to LUMRYZ, they rapidly expand their use to previously discontinued patients to new to oxybate patients. So we're sourcing patients from all patient types across all writers, growing the depth of writing. And in addition, the end of that adoption cycle, they revisit patients who are on the older therapies that they thought were doing well, and they actually now see that better is possible given their LUMRYZ experience. So we continue to fill that funnel with switch patients. So broad writer base, growing depth of writing across all patient types in parallel with the investments we've made in our sales force capacity, we can maintain that intensity of coverage on those high writers and at the same time, continue to add writers and capture the rest of the opportunity in the oxybate space. And what we see is that these lower volume offices that only have -- they only treat a small number of patients are actually quite receptive to the LUMRYZ message, the LUMRYZ profile. They see it as an easier drug to use. They really appreciate the service from Avadel and the time they spend in their office. So our growth is being driven not only from depth of writing across the writer base, but also continuing to bring on new writers persistently. That's the demand side. On the other side, the presence that we have in the office to actually drive those enrollments through to a conversion, so a conversion to a reimbursed patient. So working hand-in-hand with the office to make sure they submit the documentation they need as quickly as possible so that, that patient gets approved and becomes a reimbursed mainline patient. Then the engagement with the patient when you're initiating therapy, our specialty pharmacy engagement, our nursing engagement with that patient through the initiation process, all of these fulfillment services that we provide the office and the patient drive this percent to reimbursed conversion rate, drive increased persistency, not just in new to oxybate patients, but actually all of our patient types. So the growth that we've been seeing quarter-over-quarter is being driven by that continued productivity of expanding use of LUMRYZ across all patients. And then at the same time, really these revenue drivers, which are around percent to reimbursed patients, increased persistency. And we see all of that continuing with the investments we've made really paying off even earlier than we expected. And much of this was accomplished at the end of the fourth quarter. We saw an immediate result in the first quarter, and then we saw even better results in the second quarter, and we anticipate that persisting. I'd like to just make one more comment, if that's not enough to drive growth momentum. What we're seeing is increasing requests for LUMRYZ. So patients are coming in and requesting LUMRYZ. And because we have that presence across the broad writer base, they're familiar with the drug. They're happy to put them on LUMRYZ upon request. And that's the result of our direct-to-patient efforts, which we've also recently last quarter, even further expanded our investment there. So that's another lever that clearly another growth driver for LUMRYZ.

Wonderful. Very full answer. So in sort of penetration levels, I guess, so maybe I'm jumping too far ahead. But where do you think you'll be at the end of the year on that $265 million, $275 million number, whether it's sort of market share, patient share, give us a sense of the runway beyond that point.

Yes. Well, first of all, from a run rate, we just -- we think it's quite long and quite high from a run rate perspective. We haven't guided specifically to patients. We have obviously guided to revenue. And I think all the things that Susan talked about that have transposed into really durable improvements in our business is what gives us a lot of confidence in terms of being able to achieve our uplift in guidance that we provided at the end of Q2. So from that standpoint, we're -- the business is growing, the improvements are sustainable and every patient now that gets added is really just dropping to free cash flow.

Well, fantastic. And can you give us any sort of sense of what the discontinuation or persistency rates are in terms of numbers and how much sort of headroom you've got to go to improve upon that and how that dosing frequency might feed into that?

Well, I can say, as an innovator in the space, it's been fascinating to see now 9 quarters post launch, like once-at-bedtime -- the extended release technology enables once-at-bedtime, delivery of a full therapeutic dose and it's released aligned to the patient's natural sleep cycle and affords the patient the opportunity for uninterrupted sleep and daytime efficacy. So this whole profile of LUMRYZ is really driving the uptake. And what we're actually seeing is that the extended release profile and the benefits it affords is increasingly seen as an efficacy benefit. When we talk about persistency then if you think about the favorable profile of the drug, how well the patient is feeling on the drug, that clearly contributes to forward momentum on persistency. The level of sophistication on our patient engagement. So not only did we expand nursing capacity, but we've really elevated the level of service with credentialed nurses experiencing chronic conditions, behavioral health, predictive analytics on more customized engagement with each patient. And all of these things are continuing to move the persistency in a good direction. The last time we spoke about it was at the end of the fourth quarter, we mentioned a 14% discontinuation rate. Since then, we haven't been specific on what the rates are, but I can tell you that in the first quarter, we saw better than 14%. In the second quarter, we continue to see improvement. So -- and we are continuing to execute this in a market-leading manner where we'll hope to get -- drive that persistency to a level the market has never seen before. We'll see, but we certainly have every indication that it will continue.

A couple of questions I have on the IH degradation. So in May, you announced a favorable ruling for lifting the injection on the FDA review of LUMRYZ outside of narcolepsy. Can you provide more color here? And any updates on what the next steps are?

Yes, sure. I'll take that. So it was an important outcome, a good outcome for that decision. It allows us to pursue clinical studies, open-label extension study, study other indications for LUMRYZ and important ability to get FDA approval for any of those. Other things are happening on the litigation front. There's 2 decisions we would expect this year. One is a decision around the ongoing royalty rate on LUMRYZ. This relates to patent litigation from last year. That decision we expected any time now. The other, which is more near term and much more focused is the antitrust suit, where we've sued our competitor for being delayed for approval and entry into the market. This relates to a REMS patent that was improperly listed in the Orange Book. That patent is -- the trial is scheduled to begin November 3. We expect a decision very soon thereafter, maybe within a few days of that trial concluding. In that case, we're seeking over $1 billion of damages. So it's very important to us. It's certainly an area of shareholder focus.

And moving to LUMRYZ NIH, the clinical trial. So I think you're expected to complete enrollment this year. And can you give us a sense on maybe future time lines or the construct and design of the clinical trial?

Yes. Taking those in reverse order, Sean. So it's a -- the concept of the clinical trial design is really exactly the same as it was for the mixed salt oxybate, which has -- which demonstrated a statistically significant improvement and was the basis of their approval in idiopathic hypersomnia. And so that the trial design is well established and strong precedent at the FDA. And as you noted, we expect to complete enrollment by the end of this year. If you just forward that out from a time line standpoint, we would expect if last patient in comes in before the end of the year, last patient out will come in before the end of Q1. we should have top line data by the end of Q2 and be heading towards an NDA submission in the back half of 2026 and then a subsequent action date in 2027.

Got you. Moving on to the competitive landscape. So well, just over the weekend, a couple of data releases from Takeda and Al on the orexin 2 front. Just give us a sense of how you see the competitive position of LUMRYZ with the potential new drug class like orexin 2 agonist coming to market.

Yes. So overall, we think that the excitement around the novel mechanism of the orexin as a wakefulness agent is excellent. We were the first innovator in this space with our extended-release LUMRYZ after decades of just one single player in the space. And as a part of this innovation moving forward, we could see the durability of oxybate. I mean their proven efficacy and safety on the 24-hour condition. And as I mentioned to you before, there's a subset of patients, 2/3 of patients have nighttime symptoms. So the orexins are really being studied for their daytime effects. Today, we have patients that are -- most patients are on some kind of wake-promoting agent and then a subset are put on oxybate. And that -- so where the orexins play in this space is a novel mechanism for another wake-promoting agent, one that seems to be very effective. We'll see how things continue to pan out. But we have persistently heard in working with our physicians that we talk to every day are treating physicians who are increasingly adopting LUMRYZ, our opinion leaders. We heard panels yesterday post the orexin data releases, where it's really quite consistent that these 2 classes of therapy are complementary. So therapeutically, they're used for different intended purposes. And while orexins may be an excellent advancement for daytime symptoms and rate-promoting effects that the role of oxybate therapies and the efficacy they bring on the 24-hour condition will remain a very critical part of the whole therapeutic picture.

And that's on the orexin 2 agonist. What about competitive position does this oxybates like Xywav or even branded generic high sodium competitors?

Yes. So really, Sean, we are an innovator in this space. So introducing our proprietary extended-release technology allows for this once-at-bedtime delivery of a full therapeutic dose with uninterrupted sleep and proven daytime efficacy. And as I mentioned, what we're seeing in the marketplace as evidenced by the wider uptake and the increased depth of use across all patient types, they're seeing that patients who are put on LUMRYZ are actually doing better. And just at the SLEEP conference this week, we actually had a poster presentation with a real-world study that was conducted post approval looking at switch patients and the baseline of those patients showed them to be within somewhat of a normal ESS range. When they were switched to LUMRYZ, they got better. So that study actually proves what we're hearing from physicians in the real world in terms of LUMRYZ now being an advance in how you can deliver oxybate therapy to patients. So we are really very strongly positioned advancing the care for these patients. And when we -- in our research and we ask physicians to project their use of LUMRYZ 12 months from now, the projections are quite healthy and continuing to expand use given the way the drug has delivered in the real world with their patients and the extent to which Avadel supports them in their office for fulfillment services as well as the patient services that we deliver. So all of these things are driving the landscape towards extended release, LUMRYZ use and then ultimately, our oxybate portfolio of extended release module.

So how much of your growth do you think is coming from at the moment from taking share from Xywav, Xyrem versus naive starts?

So I mean physicians are increasingly selecting LUMRYZ over the older agents. So obviously, as the switch patients are directly coming from those agents, but previously discontinued patients. So they exhausted their opportunity on the older therapies. Now there's a new option and they're being put on LUMRYZ. And what we're -- and then [ inminooxybate ] patients, increasingly, we are the drug selected for those patients instead of the older therapies. And we're also seeing that writers who actually never used oxybate before who are now prescribing LUMRYZ. And that's because of it's an easier product to initiate with patients. And as a result, we're getting new oxybate writers as well. So we are becoming the increasingly preferred agent as well as growing the marketplace.

And just maybe one point on top of that. If you look at our mix of business today, right? The 3,100 you referenced earlier, half of those patients are switched and the other half are somewhat split between the other 2 patient segments of the oxybate and [indiscernible].

How are you thinking about net price generic alternatives become more available in the coming years?

Yes. I mean it's something we have looked at and have studied what potentially could happen with Xyrem generics full stop potentially coming into the market and what impact it may have on both the demand and on the pricing side of things. And I think from our viewpoint, we've got a great proxy of -- from a demand perspective of what may or may not occur, which is from a demand perspective, we've seen an authorized generic in the market before we ever launch. But we launched into a market with a generic in it already, and it has really had no impact on our business at all. And furthermore, there are some plans today that require a patient to step through an authorized generic for a new patient before they can get to a branded oxybate, LUMRYZ or the mixed salt product as examples. And in those plans, we perform as well, if not better, than in plans where we have a co-preferred position with. So we're quite confident that in the presence of Xyrem generics, LUMRYZ's growth and potential will continue to be there from that perspective. And from a net pricing standpoint, there's no doubt that payers will use every opportunity to try to increase their discounts and reduce their net cost. But we feel quite confident in the value proposition of LUMRYZ. It's not substitutable and that what that may mean if a Xyrem generic is preferred for new patient starts, the switch market just gets bigger, right? And when it comes to the switch landscape, if you will, for patients coming off of a to oxybate, LUMRYZ is well positioned to capture the substantial majority of that.

Sure. And how do you think about oxybate fitting into a polypharmacy approach for narcolepsy, particularly orexin 2 agents are indeed successful? And do you think will it require studies? What will potentially happen there, one at a late agent, one to knock you out?

As I mentioned, if you look at the continuum of narcolepsy patients, 80% of them are on some kind of promoting agent. So -- and then placed on oxybate. Sometimes they're taking off the weight promoting agent depending on the results for the patient, but in many cases, they're not. So polypharmacy is not unusual because of the 24-hour nature of the condition and the fact that there is a possibility for patients that aren't well managed on their daytime agents to actually be able to be treated with oxybate with very, very, very strong results. So that clearly is what happens today, and we anticipate that happening going forward. And with the innovation of extended-release oxybate like LUMRYZ, valiloxybate and then orexins for the daytime, it will just be an innovative space that will continue to offer patients options, both for monotherapy and polypharmacy.

What I would add to that is that if you research it with physicians, whether it's with a single key opinion leader or 200 physicians in a panel of research, which we've done both, -- they all want to use them together. They want to use LUMRYZ or oxybate with an orexin. They believe they're complementary and should be the standard of care in the future. And it's something we're interested and certainly wanting to explore and see how we can establish that both in terms of data generation and collaboration.

Right. Okay. So you've just recently done a deal. But if you look at maybe remind investors your cash flow and your balance sheet position? And how do you think about going beyond the potential oxybate franchise?

Yes. So maybe I'll start with where we were. We reported Q2, we had about $82 million of cash on the balance sheet. Cash flow positive for the quarter. It was a good quarter for us, profitable almost any measure, cash flow, operating income, net income. And for the year, we expect to be cash flow positive for the year. That takes into account the upfront payment we have for valiloxybate as well as any additional development costs we may incur. As we're looking -- again, as we look ahead and we think about profitability in the future, as we think about capital deployment in the future, we're focused on revenue growth, driving patient demand. We'll always be disciplined about our operating expenses, but always with an eye towards maximizing operating leverage. And then on capital deployment in the future, as we think about this, it's always through the lens of what's going to maximize shareholder value. The good news for us is we're cash flow positive. We have no debt on the balance sheet. We have a lot of different optionality for us and expectation of continued strong cash flow from LUMRYZ to support our activities.

Sure. And how do you think about geographic expansion?

Yes. There's been a lot of inbound interest in LUMRYZ ex U.S. from that standpoint by third parties. And as we announced in our valiloxybate deal, except for a few countries in Asia, we have global rights to valiloxybate as well. We do that. We'll continue to evaluate those opportunities through the lens of what I would describe as, first, do no harm to our opportunity in the U.S. from that perspective. The active pharmaceutical ingredient for LUMRYZ or for valiloxybate in the future potentially is DEA regulated. So you get quota. You only have so much product you can get. So we need to make sure that there's enough adequate product to more than meet the demands in the U.S. market. from that perspective. So that's really the lens at which we look at it. But we'll continue to evaluate those opportunities to make sure we can serve patients globally as appropriate with, of course, through the lens of what we're doing here in the U.S. now.

Fantastic. And we've got just over a minute left. But is there anything I haven't asked that I should have asked or any message that you'd like to leave investors today to wrap up the session?

No, comprehensive on the questions. I think if we think about where we are today in the next 12 to 15 months, we're in a very unique position, not only to continue to deliver on the launch and build the foundation of LUMRYZ that we've been building, but there's a number of other key catalysts and milestones coming up, whether it's completing the IH trial by the end of this year, completing final formulation work on oxybate by Q1, reading out the IH trial mid next year, filing the IH NDA second half of next year. And of course, conducting a potential registration pivotal PK study for valiloxybate. So a lot of catalysts, a lot of milestones and a lot of opportunities for us to serve more patients and build more value.

We might close the call or close proceedings there, but thank you, Greg, Susan and Tom.

Thank you, Sean.

Appreciate you coming.

Yes. Thank you, Sean.

Welcome.