All right, I'm Tiago Fauth. I'm a biotech analyst here at Wells Fargo, joined today by Harmony Biosciences. We have Jeff and Sandip. Thank you so much for making the time. Appreciate it.
Thank you, Thiago. Thanks for the invitation.
Of course. We're gonna do a fireside chat, walk through some questions. I generally like to give you guys some couple minutes early on, intro remarks, company setup, main drivers, what you're excited about, and then we'll pivot to investor day expectations, debates, so on and so forth. But, yeah, if you can kick things off.
Yeah, sure, Thiago. So excited to be here. Good morning, everyone. So yeah, at Harmony Biosciences, we are seven years into our journey and, really excited, you know, about the opportunity in building out our pipeline. It started, you know, with our initial product, WAKIX, approved in narcolepsy, with a really successful commercial launch and now five years in the market, you know, on our way to a billion-dollar plus, you know, opportunity in this novel product. You know, the first and only non-scheduled, you know, treatment, you know, for narcolepsy. And based on on that and strong sort of profitable, strong cash position, we've been building out our pipeline. And really excited about that, you know, which we'll be sharing at our upcoming Investor Day in October 1st in New York.
With regards to, you know, in past year, we've been sort of building out the pipeline very strategically, and now, you know, that involves three orphan rare CNS franchises. And in addition to our leadership position in the sleep/wake space, we've also added a neurobehavioral franchise and a rare epilepsy franchise. The importance of those is that each of those franchises have potential peak sales opportunities of $1-$2 billion. And this is a late-stage pipeline, and we're looking at eight assets across 13 development programs, three of which are in phase 3, and we about to start a fourth phase 3 program later this year. And what that sort of the pipeline is poised to deliver one new product or indication launch each year over the next five years.
So we are really excited about this late-stage pipeline, the potential for, you know, long-term, you know, revenue generation, and that's what we'll be highlighting at our Investor Day, on October 1st.
Got it. No, perfect. That makes a lot of sense. And in terms of new data for some of the assets that you recently acquired a license, like, is there anything more specific? And also, I do wanna talk a little bit about IH as an indication. It seems like you're still on track for a supplemental submission by the end of the year. Wondering, what's the background on that, right? Like, well, can you just remind us what happened with the phase three primary, and what have been the interactions with regulatory agencies so far?
Sure. Yeah, so IH is an important idiopathic hypersomnia, which is another central disorder of hypersomnolence and an adjacency to narcolepsy. So it sort of starts there, you know, WAKIX, you know, and the indication in narcolepsy. Also, as a reminder, we recently received our approval for the pediatric narcolepsy indication in June, so kind of, you know, expanding the opportunity there. So with regards to IH, we conducted a phase three trial, and it was a randomized withdrawal design. There was a regulatory precedent with regards to the only product that is approved for idiopathic hypersomnia being Xywav, one of the oxybate, you know, formulations.
In the phase three trial, we had, in the open-label dose optimization phase, we had a very strong response, at over an 80% response rate, and a high magnitude of response, over a nine-point improvement in what's called the Epworth Sleepiness Scale. Within the four-week randomized withdrawal phase, we did not hit on the primary outcome of improvement on the Epworth, possibly, you know, related to the placebo response. We didn't see the decay that was anticipated.
After that, over 90% of patients elected to go into the open-label extension, and we have, you know, many patients that have continued in the open-label extension and generating more data on effectiveness as well as long-term safety data.
It's that data that we are excited about, and we'll be sharing some of that data at the Investor Day, why we think the totality of the evidence that we have to work with in idiopathic hypersomnia, you know, leads us in terms of sort of the, you know, our conviction to pursue an sNDA. So we-
Yeah.
Yeah, so we're-
No, please.
Yeah. So we're on track in terms of the sNDA submission for IH in Q4, and we're looking at, sort of as I mentioned, the totality of the evidence from the phase three INTUNE study in IH, the long-term extension data that adds to that database, and we also have some real-world evidence from the use of WAKIX in Europe for idiopathic hypersomnia. We've had interactions with FDA, you know, around this program, this submission, and it sort of signaled the potential for, you know, regulatory flexibility with regards to the unmet medical need. And the reason that's important, as I alluded to, there's only one approved product in the market for idiopathic hypersomnia that, you know, that being Xywav.
It's a Schedule III, SSS attestation, you know, REMS product, and you have to take it at night, around, you know, 10, 11 at night, and then wake up and take it again. So for patients with IH, it's a difficult sort of dosing regimen. You know, WAKIX is dosed once daily in the morning, and has a very different mechanism.
... secondly, there's also a lot of off-label use of Schedule II stimulants.
In terms of IH. So WAKIX offers, you know, the opportunity for a non-scheduled treatment option in this patient population. It you know, as it relates to regulatory flexibility and interactions with the FDA, I've actually served as the industry representative on FDA advisory committee panels, and I've seen opportunities and for when the agency looks at the need for regulatory flexibility, where there's unmet medical need. So I've sort of been on the front lines. I've seen that, and I think with all those opportunities, we are on track to submit the sNDA and, you know, look forward to engaging with the agency.
Got it. And I guess the skepticism also comes, you only have this one regulatory precedent, right? And I think that's kind of what informed your design and expectations around that. So it sounds like the bigger data addition to what you already have is gonna be the open label extension data, right? And any hints on what are you seeing that gets you so excited? So again, I feel like the safety profile has been fairly well established.
Yeah.
But what should we expect to see as patients remain on drug, and a lot of them opted to go into the open label extension data?
Yeah. I think the best way to answer that is, you know, come to our Investor Day or stay tuned for our Investor Day. Either live in New York or it'll, you know, be webcasted as well. So you know, it's that evidence, you know, with what we are seeing in terms of, you know, durability of effect that gives us some more confidence with regards to the totality of the data and a strong case that we can make there.
Got it. And again, just on the narcolepsy side, you're on track to do over $1 billion in revenues. How would IH, if you get visibility on the regulatory pathway, and that starts to get assigned some value by the market? Like, what the market opportunity is there?
Yeah. So the market opportunity, great question. So, for narcolepsy, maybe you know start there. So, about 80,000 patients, you know, diagnosed with narcolepsy in the U.S. So for an orphan rare condition, it's a sizable opportunity. We're tapping into that, and a lot of opportunity for growth for WAKIX in narcolepsy alone, you know, and as we said, well on our way to a $1 billion-plus opportunity there.
Yeah.
IH, about eighty thousand patients living with IH in the U.S. based on epidemiologic data, about forty thousand diagnosed based on claims data. So, market opportunity, north of $500 million, you know, with regards to the IH indication. And we are-
Potential upside from p for better.
Exactly
... patient outcome, and so on, so far.
Exactly.
Okay, so again, could move the needle substantially, given that you probably receive zero value for that program right now. Is that fair, based on investor inbound?
I think that's a fair assessment, Sandip. So-
Yeah, no, I think, I think that's a fair way to look at it.
Got it. Okay, so let's talk a little bit more about the narcolepsy franchise because, so far, again, fairly steady new patient adds. Has been a very good launch by almost any metric. Can you just kind of talk about some of the puts and takes? What are some of the drivers of the success so far, and how should we think about that going forward? At some point, I'm assuming growth is gonna slow down. But, but again, like, the value inflection curve can look in a couple of different ways. What are some of the drivers that can dictate that?
Mm-hmm.
Yeah, look, we've had another strong quarter, as it... You mentioned, continued strong performance, about $172.8 million this past quarter. In terms of sales, almost 30% growth, quarter over quarter versus last year. Expect continued growth for the balance of the year, quarter over quarter. We're added about 250 new patients this past quarter, approaching 7,000 patients by the end of the year, and we also recently had the pediatric launch, and we're seeing good indication from their interest as well, which will help contribute to our growth for the period.
You have access to the whole pediatric market.
Yeah, now we have that.
The whole debate about the actual labels-
Correct
- doesn't-
Absolutely
practice doesn't matter as much. Is that fair?
Correct. Correct.
Mm-hmm.
Yeah.
Got it.
Good, good access there. We expect good, strong, continued quarter-over-quarter growth, both in terms of revenue and net patient adds. And that's what gives us the confidence, and we reiterated our guidance for this year of $700 million-$720 million in sales. Again, really strong performance, if you think about it, year five of commercialization. You don't often see that for most products, and we have good, steady progress, and we expect that to continue. And that's why it gives us even more confidence in the billion-plus opportunity, just in narcolepsy alone for WAKIX. And then this is prior to even, obviously, our next-gen formulations that we're also working on, which will help extend the pitolisant franchise for many more years.
Yeah, we've been really fortunate, you know, in terms of. It was a major unmet medical need when we launched, you know, five years ago, and sort of, you know, novel mechanism, first in class, the first and only non-scheduled, you know, treatment, sizable market opportunity of about 80,000 diagnosed patients. And also, narcolepsy is a polypharmacy market, so it's not necessarily one, you know, treatment or the other decision. You know, polypharmacy it is sort of the usual management approach. So there's also, you know, sort of, you know, that opportunity driving that as well. We have a really strong commercial model. We have a strong, you know, commercial team. The data analytics, you know, that we've been able to, you know, pursue and find, continue to sort of find new opportunities and additional levers.
But as Sandip said, you know, year five in the market in an orphan rare condition, you know, this trajectory is a bit unusual. And we continue to have the, you know, that market opportunity that we tap into to drive that growth. And I think it starts with the very unique product profile, the overall, you know, benefit-risk proposition, that sort of feeds into what we refer to as broad clinical utility. Nonscheduled, in addition to the KOLs and the sleep experts, there's a broader prescriber base, you know. And we, we've said this before, we call in about nine thousand HCPs. That's the full opportunity, the market opportunity in narcolepsy. Only four thousand of whom participate in an oxybate REMS, with regards to, you know, able to write that.
So an additional five thousand HCPs tapping into that broad clinical utility. So we've got, you know, depth of prescribing in those HCPs in the oxybate REMS, and then broad, you know, sort of the breadth of prescribing across the other five thousand HCPs. I think that continues to sort of, you know, drive our growth in narcolepsy.
Got it. And again, you're touching on, I think, one of the key debates here, which is the durability of the franchise, right? So there seems to be some room for label expansion, which is upside to where the street is, it sounds like, and just organic growth in the narcolepsy space alone. Like, I guess one of the things folks are always concerned is IP status and the ANDA filers, things like that. Can you give us a broad update? I know companies are generally limited in what they can say publicly, but so far, how do you feel about the status of that?
Yeah, so let me, let me unpack that a bit. So IP status, durability of the franchise. So with regards to the IP, I think, you know, we are very confident in the strength of our IP, and I think the base case, for those not as familiar, IP, you know, the WAKIX patent, it's based on the polymorph patent out to March of 2030. And we are pursuing pediatric exclusivity, an additional six months of regulatory exclusivity on the back end, which is a sizable commercial opportunity that would take it to September of 2030. I think importantly, the strongest commentary on the IP is we announced, you know, on Q2, that the U.S. Patent Office, there were challenges to the WAKIX IP.
Sure.
The USPTO announced the second attempt to challenge the WAKIX patents were denied. Were denied outright, and they said the decision's final and, quote, "non-appealable," giving us renewed confidence in the strength, you know, of the IP. You know, in terms of the situation with ANDA filers, just sort of overview, seven ANDA filers that came in, three of which do not claim non-infringement from the start.
Yeah.
So with that, we obviously filed suit. You know, we're in the midst of the thirty-month stay. Kind of that long process is playing out. But in the meantime, turn back to the durability of the pitolisant franchise, you know, we're working on new formulations. So, you know, life cycle management, new formulations. We have this, you know, novel first-in-class molecule that's been a very successful product in the market. So we're looking to, you know, optimize the formulations and extend the pitolisant franchise. You know, for those, we have provisional patents that have been filed and potential IP out to 2044. So, you know, that-
Yeah. Oh, sorry.
That's where we see, you know, the durability of the franchise beyond 2030 and into the mid-2040s.
Yeah, and again, you have the GR formulation and the higher dose formulation. So, yeah, what's the product. Let's start with GR, because that's a little bit more imminent there. Like, what would be the potential upside, either in terms of IP or in terms of product profile, net revenue per patient? How should we think about the impact to that, to the revenues?
Yeah. So the pitolisant GR or gastroresistant formulation, so within the lifecycle management program and the strategy. So we know that about 90% of patients with narcolepsy have, you know, things like GI comorbidity. They have nausea, they have dyspepsia, possibly related to underlying mechanism with regards to orexin hypocretin drives sort of the vagus nerve. The vagus nerve in the brain kind of controls gut motility. So there's an underlying sort of predisposition to sort of GI symptomatology. And we know that it's not really about WAKIX, because WAKIX only has about 5%-6% in terms of GI AEs, but it's more the predisposition to GI symptoms and other medications for narcolepsy. So this is a gastroresistant formulation of pitolisant to address some of that unmet need.
Our program is a fast-to-market strategy based on the demonstration of bioequivalence and with a target PDUFA in 2026. So the strategy is those patients that have been on WAKIX and maybe have discontinued, you know, there's an opportunity to sort of expand the base-
Yep.
-of patients on WAKIX in the mid-WAKIX life cycle. The other thing that we're working on is with this type of formulation, rather than having a titration dose, we're doing a dosing optimization study that we'll be starting later this year to remove the titration dose. So patients can start right at the therapeutic dose that's currently in the label and possibly get clinical benefit quicker. Rather than some patients that may have dropped off therapy because, you know, they sort of impatient-
Took a little while.
Didn't see clinical benefit. That is the strategy around Pitolisant GR.
So GR, again, on the margin, could help a little bit with some adherence early on and maybe incrementally higher revenues, perhaps. But I guess getting to a therapeutic level sooner-
Mm-hmm.
That's the better, like, that's the value proposition. Is that fair?
I think that getting to therapeutic level sooner benefits sooner, as well as those that are predisposed to GI symptomatology, it'll be better tolerated.
It's a real opportunity to expand the base of WAKIX prescribers. So this is not for those patients that are currently on WAKIX and doing well. This is really for, you know, new patients, patients that have, as Jeff mentioned, come off, or patients that have, you know, have GI symptoms, and maybe this is the right thing for them. So this is really an opportunity to add incremental patients.
Yeah
... to our overall franchise.
Let me add, I think the ability for us to do this speaks to our commercial model. So we have a patient hub, so a singular patient hub. So all the prescriptions come in to the patient hub and then a system of three specialty pharmacies. So we have patients opt in, so, you know, we have data in terms of opting in. So we have access to those patients that were on WAKIX and discontinued, and we'll be able to sort of go out in terms of the new product offering. And in, you know, those patients that have discontinued for various reasons. So as Sandip said, this is an opportunity to expand the base in the mid-WAKIX life cycle, and then we look ahead to Pitolisant HD-
I see. Yeah.
The other formulation.
Again, that sounds like it, you're gonna run not just a bioequivalence trial. That is a brand-new development program, right?
Correct.
What's the target product profile, and what gives you confidence that you can get there so far based on what you've seen?
Yeah. So the target product profile, Pitolisant HD, is the unmet need in the narcolepsy market continues to be around efficacy, the need for greater efficacy. We know that about 75% of patients or more have residual symptoms, you know, on therapy, and oftentimes on polypharmacy, on multiple therapies. So in terms of Pitolisant HD is an optimized formulation, a sort of a new formulation to generate an optimized PK profile, you know, greater exposure, milligram for milligram. And we plan to study up to two times the highest labeled dose of WAKIX.
And the goal there is generating, you know, greater efficacy, along with the gastro-resistant coating, as we said, you know, before, to address the GI potential symptoms, and also be able to start at a therapeutic dose and then take it up to a higher dosage level. So that is a full development program, targeted, you know, to PDUFA date in 2028, you know, out ahead of the WAKIX LOE. And that is really meant to extend the entire pitolisant franchise, you know, as I mentioned, out beyond 2030 to the mid-2040s, with provisional patents, you know, that we have filed, you know, potentially to 2044.
Got it. And assuming you can deliver on that, the product profile, how should we think about conversion, right? Because, again, the few comps that we have were from, I would argue, more similar product profiles than what you're proposing here. So what are some good comps, just thinking about how quickly we can convert patients to this new formulation, perhaps have even greater visibility on the tail value?
Yeah, well, I think, you know, one of the obvious sort of comps is, you know, the Xyrem to Xywav conversion, with regards to the low sodium formulation of oxybate. And, you know, Xyrem, very successful product on the market over twenty years, working through a very different mechanism of action, consolidates nighttime sleep, versus WAKIX, which is a wake-promoting agent that you take once daily in the morning. But I think, you know, the that kind of comp and about 50-60%, you know, I think conversion thus far, is, you know, something to look at with regards to... We feel we can possibly do better given the commercial model that I mentioned, and we're also looking to address the unmet medical need of even, you know, greater efficacy with the Pitolisant HD formulation.
Got it.
I think the other thing is just it also will allow us to study other areas as well, with that we don't have necessarily the runway right now to. So, for example, myotonic dystrophy is one that, you know, we had a great phase two results with something that we could pivot, as well as other, and then also expand and look at fatigue as a-
Yeah
... as another indicator. You know, so we really think HD can offer significant value beyond, beyond what we do with the current-
Yeah
-pitolisant formulation.
Yeah, that's a good reminder. Let me expand on that. So with regards to, with the runway, in terms of the, you know, the patent runway-
Yeah
... that, that's the other strategy, expanding, you know, the pitolisant franchise and lifecycle management. So, Sandip mentioned myotonic dystrophy. We did, you know, a phase two proof of concept study in patients with myotonic dystrophy and showed positive signals, not just on excessive daytime sleepiness, but a related symptom of fatigue, which is really important because a lot of chronic neurologic diseases, you know, fatigue is a common symptom. And we showed positive signals on both EDS and fatigue... but realizing that with WAKIX, we sort of don't have the runway in terms of doing that development program and getting in the market.
The combination of having the patent runway and a higher dose, because we also know there is a dose response, not just around EDS, but fatigue, gives us an opportunity to pursue additional indications, such as, you know, myotonic dystrophy and others, with the Pitolisant HD. Back in the day, I was at Cephalon back in the day, involved with Modafinil and Provigil and Armodafinil. There was a lot of interest in that target, fatigue, such as in patients with MS, patients with Parkinson's disease. This could open up a whole new opportunity for the Pitolisant franchise with IP, you know, into the twenty forties.
Got it. No, perfect. That makes sense. And again, we talked about label expansion, we talked about life cycle management. Let's talk about competition. And again, I feel like a lot of focus on orexin programs. I feel like mechanistically, everyone assumed that that would be a home run. There is a lot of value being assigned there by the market. How are you thinking about that? Either as a mechanism or just for the drug that we've seen so far, how the product profile stacks up, and how much of an impact could there really be from that?
Yeah. So orexin two agonist, I think, you know, very exciting. So very exciting. It's the next new target, you know, mechanism of action, obviously, for narcolepsy. I think directed, you know, right at the underlying pathophysiology as an orexin two agonist and the deficiency of orexin hypocretin. So we've obviously, as leaders in sleep/wake, you know, we've been following that space very closely. We've diligenced several of, you know, of those opportunities and are excited about kind of where we landed, you know, with regards to... So with our partner, Bioprojet, you know, the innovator of WAKIX, you know, we in-licensed what we think could be a best-in-class orexin two agonist.
We realize it's still early, but based on some of the things that, you know, we saw in diligence with regards to being a novel, unique kind of chemical scaffolding compared to some of the other orexin two agonists, you know, where there were some safety signals in some of those programs. We see, you know, a very potent molecule, you know, that we're working with, you know, highly selective, and some of the preclinical PK data show the opportunity for once daily dosing. So while it's early, we see a profile that could potentially, you know, be best in class. We know this space very well, and I think at our Investor Day, you know, we'll be sharing some, you know, some more data, some things that we've seen of why we're excited about that opportunity.
Yeah. And again, since you've mentioned the Investor Day again, let's talk about the broader pipeline. You briefly mentioned some of those products, but can you go into a little bit more detail, asset, commercial opportunity, why you're excited about that specific program that you're running for folks that are a little less familiar? Because, again, it sounds like all the focus is on the commercial business. Understandably so, but-
Yeah.
Hopefully, that's when we'll pivot at some point, right?
Yeah. So let's pivot now. No, we're really excited about, you know, about our pipeline, and I think the opportunity at Investor Day is to really finally give us, you know, the time and focus to share, you know, the value of this late-stage pipeline. So in addition to sort of our sleep/wake franchise that we've been talking about, the other two, you know, orphan rare sort of neuro franchises. So starting with the neurobehavioral franchise, based on our acquisition of Zynerba Pharmaceuticals, you know, we brought in what's called ZYN002. So it is a novel purely synthetic, you know, cannabidiol, devoid of THC, that we are in phase III, you know, pivotal study for Fragile X syndrome. And it's really exciting. So the behavioral symptoms of Fragile X, there's mechanistic rationale, and there are no approved treatments.
There are about eighty thousand patients living with Fragile X in the U.S. So again, a sizable... about sixty thousand diagnosed based on claims data, but a sizable market opportunity.
Between that age and our collective data profile.
Yes, and so, you know, phase III pivotal, we are on track for top-line data readout mid-next year in the Fragile X program, and you know, I think that the phase III, what's called the Reconnect Study, was informed by a phase II Connect trial, which showed, you know, positive data in those patients were called fully methylated, you know, where the symptoms are more severe, so a very informed phase III design in the Reconnect Study, on track for top-line data mid-next year, you know, and excited about what could be a sizable market opportunity.
You already hinted on it, but again, any key differences in patient population, dosing, and things like that when we're thinking about translatability, what you saw in the phase II to the phase III?
Yeah. So I think mainly in terms of dose response, so studying a higher dose, you know, in the phase III, you know, driven by what we saw in phase II, as well as what I mentioned, the fully methylated in terms of the deficiency in what's called the FMR1 gene, the fully methylated versus partially. So 80% of the study population in the phase III will be fully methylated. That'll drive this, the bigger effect size and the, you know, the, what we feel the higher probability of success. And, and then right behind this is the opportunity for a related disorder called 22q deletion syndrome, another kind of disease along the spectrum. Similar market opportunity, about 80,000 patients, positive phase two open label data in patients with 22q.
Ongoing interactions with FDA about a phase three pivotal design, so that is another opportunity with ZYN002.
Got it. But again, potentially registrational data in Fragile X by middle of next year?
Correct. Correct.
And then the rare epilepsy, can you give us the quick rundown as well? It's similar to what we've done with neurobehavioral.
Yeah, really excited about... So our acquisition of Epygenix, you know, Therapeutics brought in EPX-100, which is, it's clemizole hydrochloride. Clemizole was a first-generation antihistamine that had been in the market for about twenty years, from the late fifties to the late seventies. But a proven mechanism of action through what's called the zebrafish model for the rare epilepsies. It's a group of conditions called developmental epileptic encephalopathies. And so really excited. We are in a registrational study that we brought in from Epygenix in Dravet syndrome. And we are on track to initiate a bigger opportunity in Lennox-Gastaut syndrome, a pivotal phase three trial before the end of the year.
So I think that, you know, in the rare epilepsies, there's still significant unmet medical need from both the efficacy perspective and especially from, you know, safety perspective. The products in the market, I think, that people are aware of, you know, is Epidiolex that Jazz brought in from GW Pharma, that is a plant-based cannabidiol, with, you know, some sort of challenges around GI symptoms, have to follow LFTs. And then the other is Fintepla. You know, both good products with good efficacy. Fintepla is more challenging. It has a REMS around the issue of cardiac valvulopathy, so you need to get an echocardiogram prior to starting treatment every six months, and the risk of pulmonary arterial hypertension, so some challenges there. You know, we feel that EPX-100, the overall risk-benefit proposition could be favorable in these rare epilepsies.
Got it. And again, both of those came from recent acquisitions. I ran out the clock. I need to manage time a little bit better, but let me get one last one. Just related to that business strategy, acquisitions, capital allocation, current cash balance, how are you thinking about building the pipeline or even expanding the program that you currently have?
Yeah.
Pretty, pretty full plate, but yeah.
Yeah, no, I think, you know, the key thing is, like, we have a strong balance sheet, continue to have $434 million, just as at the end of last quarter. We're profitable, we're generating positive cash flow. We're looking at opportunities. We're continuing, even though we've had some, you know, three acquisitions in the last year, you know, we're not stopping there. We're gonna continue to look for opportunities, you know, to build within the franchise opportunities that we have currently, right now. And, you know, we certainly have access to the public markets if needed, but generally, we feel good about our position that we can continue to do this. And I think the other thing is we've done it in a thoughtful, responsible manner overall, from a capital perspective, right?
We have relatively low upfront transactions, really focusing our investments on advancing the program so we can reach value inflection points, right? And then milestones for success. You know, so that's how we've sort of structured most of these, again, in a capital efficient manner.
Yeah. And I would just add that we like our profile. We like, you know, our unique profile in terms of, you know, being profitable, you know, cash generating while we build out, you know, I think a deep late stage pipeline that we're really excited about, for more durable long-term, you know, value generation. While we are focused also helping, you know, hundreds of thousands of patients, you know, living with these rare neurologic disorders. So it's a unique profile. We're mindful of that as we go forward in terms of, you know, investing in this pipeline, and look forward to sharing more at our Investor Day on October first.
Perfect. So yeah, we'll stay tuned for that. Also, we've run out of time, but again, I really appreciate you guys making the time.
Yeah.
Very helpful.
Again, thanks for the invitation.
Thank you.
Thank you.
Take care.