Conference Transcript - HRMY 2026-06-09

Speaker 1

All right. Welcome, everyone. Good morning, and thanks for joining us here at the Goldman Sachs Global Health Care Conference. We're thrilled to be joined by the team from Harmony Biosciences today, and maybe I will start by allowing you guys to give a brief introduction to yourself and just talk about the new strategic vision that you recently unveiled at the most recent earnings call.

Jeffrey M. Dayno, CEO

Good morning, Corinne. Good morning, everyone. Thank you for the invitation on behalf of the Harmony team. So with regards to, you know, where we are sort of at Harmony, it's really an evolution of the strategy, and we think that, you know, we are identifying sort of four main strategic pillars. We think that's how we'll be valued or judged in terms of the performance and drive long-term value. So the first is really, you know, protecting the Patolis and franchise, you know, to the 2030s, and we feel, you know, we have a strong position with our IP, you know, that we can sort of dive into, you know, in terms of where we are there. You know, the second main strategic pillar of value creation is really to continue to grow the Wakex franchise, you know, while, you know, protecting the IP out to 2030. So we're on track to a billion-dollar-plus opportunity this year, you know, in narcolepsy alone and continue to, you know, extend that with the next-gen formulations. You know, the third strategic pillar is really our pipeline and deriving, you know, more value from our pipeline with our late-stage programs, and now really it's, you know, all about, you know, the Erexin, sort of the Erexin opportunity. That's obviously a very large opportunity, a lot of excitement about that, and we feel we have a potential best-in-class Erexin, and we can spend a little time on that opportunity. And then last is sort of BD, business development, and with our strong balance sheet, a renewed emphasis and a conviction to really transact in BD to build out the pipeline and expand the commercial portfolio. So that's sort of the framework how we think we will be sort of valued and judged, and when we execute on those four pillars to drive long-term value for our shareholders. Great.

Speaker 1

Maybe we'll talk about the litigation quickly and get that one out of the way. I guess recently you had a lawsuit with NVIDIA that you filed against AET, and it helps to kind of map to that goal you said about protecting the WICU franchise to 2030. Could you just talk about that update and then the confidence that you derive from there in the IP?

Jeffrey M. Dayno, CEO

Absolutely. I think, again, we feel really strong and confident in the strength of our IP out to 2030. And I think Peter can sort of expand on, you know, the licensed Novidian patent and this multi-layered strategy with regards to protecting our IP.

Peter Nassasio, COO

Yeah, just real quickly to introduce myself, I'm Peter Nassasio. I'm the Chief Operating Officer. I was on the board for the last three years, so I've been an active participant in the Harmony story for the last three years, and I joined the management team about two months But just to clarify on the IP, we have two cases that are going on. One is the ANDA that had the court case in February. That continues, and we feel very strongly about our ability to prevail in that litigation. But in addition to that, during that trial, AET and Sandoz introduced a significant amount of evidence that they are infringing upon a polymorphous patent that we have exclusively licensed from Novidium. So at that time, we decided in April, together with Novidium, that we would file a lawsuit defending our rights from infringement. And so that is at the beginning of the trial. That has its own course of 24 to 30 months. Then you have to add appeals to it. It's another 18 months. So that's why we feel so confident, as Jeff said, that we will have IP through March of 2030. through March of 2030, and that is because if the court cases go to their full extreme, we feel very strongly in our ability to win, but also because of the strong hand we have, we believe it also enables a settlement to be reached. And so either way, the clear message is March of 2030 is our IP.

Jeffrey M. Dayno, CEO

Inclusive the six months of pediatric exclusivity.

Speaker 1

We're going to come back to the WakeX franchise, but I know that one of the key areas of focus for you guys right now is the orexin, so I wanted to start there in terms of products. Maybe on that front, you acquired the orexin-2 agonist a couple of years ago now. How are you thinking about a class of agents and their potential in narcolepsy, particularly given a relatively crowded set of therapies?

Jeffrey M. Dayno, CEO

Yeah, so obviously the orexin space is a really exciting one, and as I said, you know, we feel in BP-205 we have a potential best-in-class. So maybe to take a step back, you know, the reasons why we're excited about that, And then I think, you know, the team can expand on, you know, where we see that class going and our opportunity. So BP-205, what is unique, you know, it has a unique chemical structure and chemical scaffold, which differentiates from the other orexin-2 compounds in the clinic. And based on that, it drives the attributes, you know, of this compound. So the first is potency and being the most potent Erexin-2 agonist in the clinic right now. And potency matters with regards to the ability to have lower doses and drive greater efficacy, but also acceptable safety tolerability profile. So a lot of it comes down to sort of a risk-benefit assessment in terms of what that profile will be. In addition to potency, there's excellent selectivity of the orexin-2 receptor over orexin-1, and as the preclinical data have shown, and we're now in the clinic in terms of, you know, to bear that out, potential for once-daily dosing and a very, you know, clean in terms of the safety tox data, you know, that we've demonstrated there. So I think with that, the potential, not only for sleep-wake disorders, but again, beyond NT1, which is a disorder of erection deficiency, when you move into NT2 and IH, and then these broader CNS targets where there's a lot of discussion around, potency really matters to be able to have enough potency to drive efficacy with acceptable safety tolerability.

Speaker 1

Obviously, this is a key piece of why you guys acquired that asset. And maybe you could just put a bit of a finer point on exactly how you think that could play out in terms of clinical differentiation and meaningfulness with respect to the specific side effect profile that you could see here.

Jeffrey M. Dayno, CEO

So, you know, I think that it's the ability to dose lower and drive strong efficacy. And based on the preclinical data that we've seen and we're now in the clinic, with regards to sort of side effects that are on target in terms of lower percentages of those side effects and minimizing and avoiding the off-target effects. And I think that where we're seeing the class, Peter, from a commercial perspective, where we see those opportunities.

Peter Nassasio, COO

Yeah, just that rarely in a new class does the first entrant, is it the best entrant? And so we believe we have the best entrant And for all the reasons that Jeff mentioned, I would add one more, and that is the once a day. One of the things that we hear is split dosing is a challenge for some of these patients, especially in the open-label phases of the clinical trials. So we believe pretty strongly that we're going to be once a day. And so we believe we're going to be bringing into the market the best offering among the orexins, and it does give us the chance to take advantage of all the opportunities that exist in the space, not just in narcolepsy, but also in those other broader indications because of the features of the drug, particularly the potency.

Speaker 1

As we approach these are actually entering the market here. Do you anticipate any impact to your Wakex franchise in narcolepsy?

Peter Nassasio, COO

I can answer that. The short answer is no. And I can point to a couple of things. So when we were the first new mechanism to come out about seven years ago, we had incredible growth and still do, but it didn't impact the growth of the oxabates. And that's because this market has a high degree of unmet need. Doctors use polypharmacy as more the norm than the exception. These patients are highly heterogeneous. And so having multiple mechanisms to treat these patients is really kind of the standard. And so we expect that we'll continue. Wakix has been on the market now seven years It has an established efficacy and safety profile. Doctors are comfortable with it. They know the value that it brings. And so we expect it to be resilient in the marketplace and continue to grow, even with the orexins coming.

Speaker 1

And you're planning to share Phase 1 data in healthy volunteers this year. As you think about the hypothesis you just laid out, what kind of results would kind of advance that kind of hypothesis?

Jeffrey M. Dayno, CEO

So where we are in the clinic. So we are, you know, in the clinic with healthy volunteer, you know, phase one PK data. So we're right around the corner from the single ascending dose data, you know, that we'll be sharing the first opportunity we have. And really that will confirm sort of the profile and the potential for once daily dosing that we saw kind of from the preclinical PK data. And we want to, you know, confirm that in the clinic with healthy volunteers. And then later this year, the multiple ascending dose data in healthy volunteers, you know, we'll be sharing those data. And importantly, we'll be submitting an IND shortly, and then we'll be doing the sleep-deprived healthy volunteer study this year early next year. And that'll be the first sort of signal in terms of signals of efficacy in that model, potentially at lower doses and once-a-day doses, you know, with BP-205 compared to some of the other orexin programs, you know, in the clinic where they started, you know, with once-daily dosing and except for Takeda, which is BID and NT1, and then other programs went to, you know, sort of the split dosing paradigm. So we feel we have the potential, once daily dosing, at lower doses to drive strong efficacy, and those sets of data will bear that out.

Speaker 1

Okay. So as you think about the metrics you'll be sharing with these updates near term, what should investors be paying attention to, and how would we think about the right benchmarks as we assess those results relative to the broader class?

Jeffrey M. Dayno, CEO

So I think it's looking for a favorable PK profile of short T-max in terms of time to onset and then a half-life that can support once daily dosing and minimize in terms of the on-target effect of insomnia.

Peter Nassasio, COO

It's also worth noting that as far as we know, the competition hasn't shown some of those early PK data, so they're not out there. And so we intend to share ours. and so I think it'll be viewed positively and really shows that the potential we're talking about is starting to bear itself out in the clinic.

Speaker 1

In terms of safety and tolerability, I guess, when would you expect those sort of events to emerge and so at what point can we say pretty definitively this does have the better tolerability profile you're guiding to?

Jeffrey M. Dayno, CEO

So obviously the more patients that you accrue in the clinic and the clinical trials, so I think we'll get initial signals with regards to you know, what we're seeing, especially in the sleep-deprived healthy volunteer study, the phase 1b study. And then when we move into sort of phase 2 and accruing more patients, we'll get a pretty good read, you know, with regards to what we believe will be a, you know, a favorable safety tolerability profile.

Speaker 1

Okay. So once you get past that, maybe you could speak to the broader development strategy that your communications are you planning to prioritize guys here.

Jeffrey M. Dayno, CEO

You know, Peter and Glenn, I think we all have a lot of thoughts on this. So obviously the initial targets in the sleep-wake space, you know, which started, you know, this whole opportunity. And remember, beyond NT1, these are, you know, not disorders of erection deficiency, which is where we think, you know, a more potent compound can be beneficial. So I think that, you know, we have that opportunity, and then these broader CNS targets, you know, the potential in cognition um you know in adhd in mood disorders fatigue and and really where we are now so we're working with our partner bioproge beyond bp205 for additional uh compounds the rex and two agonists because you know you'll need if you're going into sleep wake and orphan rare um you'll need other compounds follow-ons if you go to broader cns indications you know different commercial model different price point so we are assessing all those opportunities and

Peter Nassasio, COO

i think we said you know later this year we'll be providing kind of an update of the development strategy if you want to add anything no i would just emphasize that we are committed with our partner buyer appreciate to aggressively develop this and to take advantage of the variety of indications that this asset could be targeted for and and as jeff said later this year we'll give a substantive update on some of those specifics.

Speaker 1

Okay. We'll look forward to that. Maybe in terms of the ability to look at other people's providing proof of concept in different indications versus doing it yourself, how are you going to prioritize which indications you kind of take a lead on? Yeah.

Jeffrey M. Dayno, CEO

So I think, you know, being a little behind, we've always said, you know, we're learning from some of those other programs. But in addition, we're also working with our partner BioPriget at the bench in terms of preclinical models in some of these broader cns targets you know that i mentioned so we will also have those data to inform you know our strategy and the other opportunity that um out there is you know there's a potential for synergistic mechanism you know between an erexin 2 agonist you know and pitocin and a histamine 3 um you know antagonist so we are also looking at preclinical models of the potential for synergy between pitolocin and an orexin agonist and that could afford an opportunity sort of down the road for fixed dose you know combination drug development and we're also working on that opportunity with our partner BioProject.

Peter Nassasio, COO

The only thing I just wanted to put in some perspective that while we can concede that we won't be first in NT1 because of the aggressive development approach that we plan to take, there's a real chance we could be first or second in some of these other indications. And so that's, I think, one of the other areas of differentiation with a compound.

Speaker 1

Yeah, it's a good point. So how do you think about balancing where you're going to invest dollars in and how important is being kind of first to market in some of those other indications versus kind of following in more established indications for the category?

Peter Nassasio, COO

I think the most important thing is the profile. And a strong profile can succeed in any market, even if you're fourth, fifth, sixth. We won't be. But that's the most important part. But if you concede that all these drugs will be good in NT1, where we think we can really shine is in these other areas, and that's where we intend and believe we can be first or second, with also the best profile.

Jeffrey M. Dayno, CEO

Yeah, and in terms of the investment, you know, we now, you know, we see the opportunity and have talked about investing, you know, in a broader, you know, EREX and development program. You know, we're also looking at, you know, the rest of our pipeline and, you know, reassessing in terms of where can we drive the greatest value from the pipeline programs and a broader, you know, EREX and program.

Speaker 1

Great. So you mentioned the development learnings that you can take away from leaders in the class. but maybe we could talk about the commercial launches that we start to expect over the course of the next couple of years. What will you be watching in terms of their commercial progress and how are you going to take that learning into account as you think about your own?

Peter Nassasio, COO

Do you want to do this? Yeah, let's go ahead and go ahead. I think several things, several things. First and foremost is what does the profile look like in the real world? We all know that for all drugs, the clinical environment is not the same as the real-world environment. clinical environment, patients are very homogenous, there's no comorbidities, there's very strict rules around what concomitant meds you can take and not take. So the real world profile, I think, for any drug is critically important. So some of the long-term efficacy that is unknown about these competitive products will remain to be seen. The long-term tolerability when you get into broader populations. So those are clearly some of the things that we're looking for, but also things like price. So it's, you know, depending, there's a lot of rumors out there about what Takeda will price that, that makes a big impact on, you know, the payer access situation and patient's ability to get those. So those are a number of things that we'll be watching. But at the end of the day, all we can control is what we do with Wakings. And so we're continuing to be focused on driving that long-term efficacy, short and long-term efficacy, short and long-term tolerability. It's the only unique mechanism that's in the market beyond the oxabates and has its own place carved out because of its unique mechanism, even in the face of orexins, and it's also still the only non-scheduled product. So that's where we'll be focusing, but, of course, we'll be paying attention to some of these other factors.

Glenn Reicin, CFO

With respect to figuring out indications on the orexins, I think what you're going to see is a process. You see a pretty broad effort on Phase II, and then we'll have the data dictate, but the selection of the targets will really be determined by our strengths, right? So we're looking for areas with great pricing, kind of niche-y where we can address it with our sales force and add value with respect to our hub and the way we get reimbursement for patients and treat patients.

Jeffrey M. Dayno, CEO

Yeah, I think, you know, the opportunity for WACAX for me, we still believe that it will continue to be a polypharmacy market. I know there's a lot of debate, you know, around that, But chronic CNS disorder, you know, difficult to treat symptoms, often you need multiple mechanisms to really control these patients. So, you know, as Peter said, Wakex has been in the market seven years, you know, well-established, our commercial model. So I think there continues to be, you know, that opportunity. Pricing, obviously, in terms of place in therapy will have an impact. And, you know, while that's happening, we'll be aggressively advancing our erexin to agonist programs, sleep-wake, looking at, you know, phase two proof of concepts in these other targets, and, you know, sort of guide, let the data drive us and guide us in terms of, you know, what the best opportunities will be.

Glenn Reicin, CFO

In terms of prioritizing R&D, what we're going through over the next couple of months is just looking at our entire portfolio of products and figuring out where we're getting our best return. The last thing we want to do is not have enough money to fund the most exciting opportunities in front of us. So we're going through that process. We're going to really test the P&L pretty hard just to make sure we're fully funding everything into 2030.

Speaker 1

Can I ask a follow-up on that point, which is that as you're doing this, I imagine you're also taking into consideration what Harmony's real strengths are. So if you think about the core competencies of the business, what are those and how do they inform the development strategy and prioritization that you're undertaking as well?

Jeffrey M. Dayno, CEO

No, it's a great question. So I think our core competencies are really a lot of expertise in the CNS arena, I think, and not just sleep-wake, but epilepsy and other target indications, including some of the broader ones based our R&D team and their sort of backgrounds and their experience. So I think that is an important part, along with, obviously, the commercial prowess and the strong commercial engine that we've developed, the unique commercial model. So we would be able to apply that to other orphan rare CNS indications, other rare indications outside CNS. So I think that will all inform as we move forward with the Erexen program. Jeff, maybe talk a little bit about a partner as well. I appreciate it. That's a key advantage as well. So that's a good point. So, you know, Bio4J, our partner who were the innovators of Wakex, of Pitolocin, actually the principal scientist, John Charles Schwartz, discovered the histamine 3 receptor. So the seed of the science sits there. So they're really strong, you know, at the bench in terms of their, you know, basic R&D and preclinical models. And that's who we are collaborating with in terms of advancing the Erexin program. So they have a lot of strength there. And it provides kind of our research arm. you know, working with them closely on the Erexin opportunity.

Peter Nassasio, COO

I would just add, I think at this point we've established ourselves as the leader in the sleep-wake market across all facets, commercial certainly, but also R&D, advocacy. We know the KOLs, we know the advocacy groups, they know us. We've been obviously successful in the market and expect that that's one of our superpowers and will continue to be as we introduce GR and HD, but also the orexin as well.

Speaker 1

So one of the things you mentioned in that list was the commercial prowess. That's a good segue to WAKEX. You've guided to reaching blockbuster status this year. I guess, what does that embed with respect to patient growth? And how are you guys continuing to deliver such good kind of patient growth this well into the commercialization of the product?

Jeffrey M. Dayno, CEO

I'll let Peter expand on that as a long history with his commercial expertise.

Peter Nassasio, COO

Yeah, I mean, it all starts with the product. Again, I know we keep repeating it, but it is the only unique mechanism relative to the Oxabates. It has its own place carved out. It's a known efficacy and safety profile. And then, of course, we have demonstrated strength in commercial. And so we don't take anything for granted. There's a strong growth trajectory, but we are constantly innovating and sometimes incrementally, sometimes more so. So we recently expanded our footprint, both in the sales force, but also in specialty pharmacy and hub, our field reimbursement managers, getting to more prescribers, helping more patients get through the process from a prescription to a paid Rx. For rare disorders, especially at this type of price point and higher, there's a lot of support that's needed. And so we're constantly innovating and tweaking our model to be able to help with that. And it's paying dividends. We had strong growth last year. We're on track to get the billion dollars, and we're seeing some very strong growth this year as well. And so we expect that to continue.

Jeffrey M. Dayno, CEO

Yeah, so, you know, you've followed this story for a while, and we've always said, you know, it's a unique profile. You know, it's the first and only non-scheduled product, and, you know, when I saw those data from the abuse liability study, you know, read out, you know, I realized, you know, this could be something special. And remember, it's still a large market for an orphan rare condition. It's still a sizable market. We continue to sort of tap into that.

Peter Nassasio, COO

Yeah, there are 90,000 patients that are undiagnosed and untreated.

Jeffrey M. Dayno, CEO

So, you know, it continues to grow. Top-line demand is strong, and, you know, we believe we can continue to drive that and then into the, you know, the next-gen new formulations of the Tolson.

Speaker 1

Thank you for the segue. I wanted to talk about lifecycle management. So at a high level, maybe you could just talk about where you see the gastric-resistant and high-dose formulations fitting within the context of the broader franchise.

Jeffrey M. Dayno, CEO

So latest update on that, and then I can, you know, turn to Peter in terms of strategy, the commercial strategy. So as we've said, you know, that we were going to be submitting the NDA for Patulsan GR in the second quarter. So we submitted the NDA, and we are on track for Target to do the first quarter next year. We see that as a significant opportunity right around the corner to extend the Patulsan franchise, you know, out to March of 2030, which is our base case LOE. Also, Pitocin GR and HD have utility patents filed to 2044 as well. In terms of the commercial opportunity, I think Peter can expand on that.

Peter Nassasio, COO

As good of a product as Wakix is, as we've said, there are ways, and back to the point about constantly innovating and adding additional value, we believe that GR can be an incremental step forward, even already on a great profile with Wakix. And the main area is because of the GR coding, we believe it's going to be very helpful for narcolepsy patients because narcolepsy patients have a high degree, 80 to 90 percent of them, this is irrespective of Wacix, just as part of their disease, they have a high degree of GI symptoms that kind of co-travel with their disease. So they're always very sensitive to GI side effects. So having the GR formulation will certainly help that. But also what that enables us to do is right now there's a two-step titration with Wacix. And so by having the GR formulation, it should help us avoid the first step in the titration and get right to a therapeutic dose from the very first day of treatment. And so these are incremental advancements on an already good profile, very strong profile. And so we plan to launch it in Q1, and we think it'll be helpful to patients. And also, as Jeff said, because of its IP, be helpful long-term beyond 2030.

Speaker 1

On the high dose, could you speak to what you view as clinically meaningful in terms of incremental efficacy you could achieve at a higher dose? And I know one of the areas you've spoken to is kind of showing benefit on fatigue. So maybe you could embed that in the answer to this question.

Jeffrey M. Dayno, CEO

So I think that, you know, I think the bar is demonstrating, you know, what's clinically meaningful in terms of the two- to three-point improvement, you know, over WACIX, you know, the labeled data on the F4 sleepiness scale. So we have data from the development program in terms of dose response, and we feel at about, you know, two times the current maximum labeled dose with Pitulsin HD, which is also, it's also a unique formulation. So it's not bioequivalent. It's got greater bioavailability, milligram for milligram, and we're at about two times the highest labeled dose currently for WACIX. So we feel we can drive clinically meaningful benefit, you know, improvement, two to three point, you know, at a minimum on the Epworth reduction in cataplexy. And then the phase three trial in narcolepsy is also including fatigue as a secondary endpoint. And in terms of demonstrating improvement in fatigue, so differentiated labeling, and about 60% to 70% of patients with narcolepsy also experience fatigue as another sort of debilitating symptom.

Speaker 1

So how do you think about what portion of patients are going to be good candidates for a switch if you deliver on that kind of profile?

Peter Nassasio, COO

If I can add just one thing before we answer that question is the idiopathic hypersomnia program that we're pursuing, which is not an indication that Wacix has, but it will be an indication that HD has. So that's even additional differentiation. And even in the face of generics post-2030, we think that, in addition to all the things that Jeff said, will help Wacix HD continue to be a thriving formulation because it has an indication generic Wacix won't.

Speaker 1

Sure. Okay. So maybe on that, the percentage of patients that are currently on Wakex that you think would be good candidates to switch to high dose, assuming the profile you described?

Peter Nassasio, COO

Yeah, well, we certainly haven't guided a specific, but I think we point to pretty frequently the Xyrem, Xywave analog as something that we believe we can achieve or do better with a switch. And so we believe that there's more benefits to both the GR and the HD than XyWave gave over XyRum. So I think with more differentiation in those two formulations, we think we can do that and possibly better.

Jeffrey M. Dayno, CEO

And maybe some comments on the commercial model, so the opportunity we have starting with GR.

Peter Nassasio, COO

Yeah, so again, this product is not distributed in retail pharmacies. It's a closed distribution network of specialty pharmacies and a hub that manages all this data. And so we have data on all the patients, all the prescribers for WAKIX. And so that's also something that we can leverage to be able to share the benefits of both GR and HD with patients that are currently on the product as a potential switch opportunity. but just as important, patients who maybe have tried Wacix in the past and have left Wacix for some reason to bring them back with one of these two new formulations.

Jeffrey M. Dayno, CEO

Yes, I think the opportunity to extend the Patulsan franchise is right around the corner with the NDA submission for GR and the target Bidufa in first quarter next year, really starting in terms of to extend the franchise and then the HD program. You know, currently phase three, as Peter mentioned, both narcolepsy and the IH study. And then for IH, we're also looking at, in addition to excessive daytime sleepiness, sleep inertia as a unique sort of endpoint to get data in the label and have differentiated labeling for the IH program as well.

Speaker 1

Okay, great. I wanted to quickly talk about business development. You've got quite a bit of cash on the balance sheet, and you have talked about business development as being a key pillar. So maybe you could just talk about the areas of focus with respect to indication, size of the asset, stage of development, and I'll let you guys kind of go from there.

Jeffrey M. Dayno, CEO

Yeah. So from a BD perspective, I think, you know, the strategy continues to evolve. And as I mentioned up front, you know, renewed emphasis and conviction to transact, especially with a very strong balance sheet, continue, you know, strategic and thoughtful. You know, we've gone deep in several opportunities, but I think for the right reason, you know, have not pulled the trigger yet. Glenn can expand on the current thinking and where we are in business development.

Glenn Reicin, CFO

Yeah, obviously I like a big balance sheet, so you have the optionality of doing transformative, something transformative. I think that term scares a lot of people, so that's not really our inclination to do something that's transformative. What will most likely happen here is we're going to do a series of smaller transactions, all playing into our strengths in terms of niche neuroscience opportunities. Our biggest emphasis are on those products that are complementary to what we're selling right now that would contribute to revenues in the 2028 to 2032 timeframe. And the reason we kind of picked that timeframe is obviously we have to deal with the threat of orexins between now and 2030, and then post-2030, you have an LOE to deal with. And at that point in time, we're just beginning, hopefully, for the takeoff of the orexins for our own orexin program. So that seems to be the sweet spot in terms of revenues.

Speaker 1

Okay. In terms of capital allocation priorities, how does shareholder returns kind of rank relative to…

Glenn Reicin, CFO

I heard that question last time that you asked in terms of shareholder returns. We're very cognizant of shareholder returns because we're all shareholders, and I certainly want our employees to think of it that way. And so it has to make sense, obviously, from a return on investment perspective. I think it would help if it was obvious to investors. But in terms of share repurchase, it continues to be my strong belief that we can do better for shareholders investing in the business, either our EREXM program or with BD than it would be to return cash to shareholders today. I'm not ruling that out, but that's where the priority is right now.

Jeffrey M. Dayno, CEO

Yeah, and we don't think it's either or. We think the opportunities are both, you know, in investing in good BD opportunities as well as this broader EREXM program that, you know, we're really starting to accelerate and focus on. and maybe some of the other strategic filters in BD in terms of what the types of deals, you know.

Glenn Reicin, CFO

Well, I mean, the Sintessa deal was a blessing in some ways because we're able to really show folks what a transformation to a biotech entity really would look like. So here we are, a company that is fighting it out to generate a billion dollars of revenue, and we're sitting on close to a billion dollars of cash, and we sell at a market cap of $1.7 billion, we are undervalued. But then you look at Syntessa being bought in a range of $68 billion, you can see how transformative one molecule that's unique can be to an organization. So obviously if we can identify that molecule either through a BD deal or our own portfolio, we can create tremendous value for folks, particularly with 205, the RRX and Agnes.

Speaker 1

Yeah, of course. Maybe in the last minute we have here, I just want to give you a chance to talk about the epilepsy data we'll expect later next year and just what should we be looking for there.

Jeffrey M. Dayno, CEO

Yeah, so EPX100, you know, currently in Phase 3 for both Trave and LGS. I, you know, on target for top-line data next year in 2027. It's really similar to some of the long-term extension data that we shared last year at the AES meeting showing, I think, the profile of efficacy, about 50% responder rate in terms of kind of the bar of entry for showing good efficacy, but more importantly, with a very good safety tolerability profile. The profile of EPX100, clemozol hydrochloride, is very similar to another product in a polypharmacy market, strong efficacy with very favorable safety tolerability profile. And that product is called Wakex with regards to the broad clinical utility and the overall benefit-risk proposition in a polypharmacy market. We know there's a lot of competition in that space, but we feel with EPX100 we can have a very strong product profile and strong offering for both Gervais and the opportunity and LGS.

Speaker 1

With that, I think we're at time this morning, and thanks to everyone who joined us here on Online.