Welcome, everyone. I'm Sanjibita with J.P. Morgan Healthcare, and we are pleased to have with us Dr. Jeffrey M. Dayno, President and CEO of Harmony Biosciences. For logistical purposes, please reserve any questions you may have till the end of the presentation. With that, I will let Jeffrey take over.
Thank you, Sanjibita. Good afternoon, everyone, and thank you for attending our session late on a Wednesday afternoon. Appreciate your interest in Harmony. And on behalf of the Harmony team, our thanks to J.P. Morgan for the invitation to present again, this year. Our forward-looking statements, please refer to our SEC filings for the latest information. So for those of you newer to the story, excited to share with you today, Harmony Biosciences and, and who we are. So we are now, 260 members strong, sort of industry veterans, and we specialize in developing and commercializing innovative treatments for patients living with rare neurological diseases and other, disorders with unmet medical needs. We're 7 years into our journey, our journey of growth, and, and we've been busy, and that's why this slide looks so busy.
Let me just share a few highlights along our past seven years. We were established in October 2017, based on securing an exclusive license, U.S. license for WAKIX from our partner, Bioprojet, the innovator of WAKIX or pitolisant. And I'm pleased, actually, the CEO of Bioprojet, Jean-Guillaume Lecomte, is here with us today, and we've had a great partnership over the years. Thank you, Jean-Guillaume. From there, we basically opened the IND in 2018. Refer to 2018 as the year of the NDA, and we also received both Fast Track and Breakthrough Therapy designation for pitolisant that year.
2019 was our first approval, the FDA approval of Wakix for the treatment of excessive daytime sleepiness in narcolepsy in August 2019, and then we launched Wakix into the market in November that year. In 2020, we received our second indication for the treatment of cataplexy in adult patients with narcolepsy. We also started working on our lifecycle management programs and opening INDs for follow-on indications. In 2021, Wakix was added to the American Academy of Sleep Medicine treatment guidelines for central disorders of hypersomnolence, receiving a strong recommendation for the treatment of both excessive daytime sleepiness, or EDS, and cataplexy. The importance of that, the only other treatments approved for both of the indications were sodium oxybate, the oxybates, and then Wakix got the approval for both indications.
In 2022, we reported top-line positive signals from a phase II proof of concept study in patients with Prader-Willi syndrome, a rare neurodevelopmental disorder, demonstrating improvement and clinically relevant improvement in both excessive daytime sleepiness and behavioral symptoms. Then turning to 2023, let me share with you some of the accomplishments last year that we achieved. As we reported, a full year 2023 WAKIX net revenue of $582 million, representing 33% growth year-over-year, ending the year at 66,150 average number of patients on WAKIX. We were also really active advancing our clinical development programs and expanding and building out our pipeline.
We announced the acquisition of Zynerba Pharmaceuticals last October and brought in ZYN002, an interesting, innovative synthetic cannabidiol, in phase III for Fragile X syndrome and another phase III-ready program in a related disorder, 22q deletion syndrome. We reported our top-line results from our phase III INTUNE study in IH. We advanced our Prader-Willi syndrome program and are ready to initiate a pivotal phase III study later this quarter. And then last month, late last year, another phase II proof of concept study in another rare neurological disorder, type 1 myotonic dystrophy. We re-reported positive signals from this proof of concept study in improvement in both excessive daytime sleepiness and fatigue, two key symptoms in that patient population, in addition to the neuromuscular symptoms. Also, last month, we submitted an sNDA for pediatric narcolepsy.
And importantly, we're working with our partner, Bioprojet, on next gen new formulations of pitolisant, and I'll provide a little more color on that. So we are, you know, profitable, cash generating. The end of Q3 last year, $438 million on the balance sheet, and it also initiated a share repurchase program. Repurchased 3.2 million shares at a cost of $100 million over the course of last year, and we have a remaining authorization for another $150 million. So that brings us to Harmony today, 2024. So we're a profitable and rapidly growing CNS-focused company. Obviously, strong commercial success for WAKIX in adult narcolepsy.
I shared that with you in terms of the performance last year, and importantly, the potential of a billion-dollar-plus net revenue in adult narcolepsy alone, and we're well on our way there. We have an expanding late-stage pipeline with multiple three phase III assets, and if successful in those, that represents another about a 100,000 diagnosed patient opportunity, an additional billion-dollar revenue opportunity there. The new next-gen pitolisant-based formulations are designed to generate new IP. So taking the franchise now from 2030, potentially out beyond 2040 and beyond. So our priorities for this year are really to continue to drive the commercial success and the strong growth for WAKIX in narcolepsy.
As we guided to $700-$720 million net revenue for the year, growing to about 7,000 patients by year-end, and advancing the clinical development programs. We look forward to reporting the initial pharmacokinetic or PK data on the next-gen pitolisant formulations the first half of this year. We're driving patient enrollment in the phase III pivotal RECONNECT trial of ZYN002 in Fragile X syndrome. We are initiating the phase III TEMPO study in patients with Prader-Willi syndrome later this quarter. We submitted a request to the FDA to meet to discuss our program in idiopathic hypersomnia or IH, and we anticipate meeting with the agency later this quarter, and then we'll provide an update to the market on a path forward.
And then we're completing the review of the full dataset after we reported top-line readout from the DM1 phase 2 proof of concept study and strong and robust signals that we saw an improvement in EDS, and fatigue. We'll assess that opportunity going forward with regards to, you know, how we advance the program. And we're looking in terms of, you know, disciplined capital allocation to maximize shareholder value. That's sort of been part of our, our culture at Harmony from the beginning. Actively pursuing business development to expand our pipeline and diversify our portfolio, and we'll continue to be opportunistic on the execution of the share repurchase program as well.
So in our first four years in the market, this slide shows you we've demonstrated a strong track record of commercial performance, leading up to how we guided this year, as I said, you know, $700 million-$720 million in WAKIX annual net revenue. This is based on really solid underlying business fundamentals driving our growth, and you see this continued growth while we've been in the market. And just to highlight a few things, in the second quarter last year, we had our highest number of new patient starts in year four in an orphan rare launch and commercialization, you know, which is not typical. And then last quarter, we had our highest quarter of net sales in our history at $168 million.
We have more unique prescribers of WAKIX than sodium oxybate, obviously a leader in the class, in the field, you know, that's been in the market for over 20 years. And despite the entrance of generic oxybate products, a once-nightly formulation, we've maintained strong market access coverage in about 84% of covered lives. And this slide demonstrates, I think, you know, one of the reasons for the growth of WAKIX in adult narcolepsy, and it speaks to a differentiated product profile. And also a first-in-class molecule with a novel mechanism of action coming from the innovation of Bioprojet, and where the principal scientist, Jean-Charles Schwartz, is the one who discovered the histamine H3 receptor in the brain, which is the target mechanism of action for WAKIX.
But we also, from the beginning, when we were established as a company, we listened to patients. We deeply listened, and as you see on the left of this slide, to the unmet needs in terms of the current treatment options back before we launched. And then if you look to the right in terms of the product profile, you see it's well-aligned and leading off with, you know, probably the strongest differentiator. It's the first and only FDA product approved for narcolepsy that's not scheduled as a controlled substance. And I'll, I'll share with you the relevance of that in a few minutes. It's approved for both excessive daytime sleepiness and cataplexy. And importantly, it fits into patients' lives.
It's taken once daily in the morning upon awakening, as opposed to some of the other dosing regimens for, you know, some of the other products to treat narcolepsy. It can be used as monotherapy, but more often in this polypharmacy market, where most patients are on multiple agents, it can be easily added on patients on a traditional stimulant, on a wake-promoting agent such as modafinil, easily added on without stopping that treatment to treat the residual symptoms of either EDS or cataplexy. So although this is a rare disease, it's a sizable market opportunity and continues to be. It's about 80,000 patients in the U.S. diagnosed with narcolepsy, which is sort of the current, you know, WAKIX opportunity. And even if it doesn't grow, the market doesn't grow, we keep tapping into that potential.
In 2022, it was estimated to be the narcolepsy market, about $2.5 billion, expected to grow to about $5 billion by 2030. And we have a unique product profile, tapping into the market. So this slide really describes, you know, why this is happening, why we're confident in WAKIX being a billion-dollar-plus opportunity in terms of the broad clinical utility of this product profile. So we're calling on 9,000 HCPs. That really covers almost 100% of the narcolepsy market. 4,000 of these HCPs are enrolled in an oxybate REMS. They are the KOLs or the early adopters. They have more patients in their clinic, came on early, but we continue to see depth of prescribing in that segment of HCPs.
But in addition, and based on strong commercial analytics, there's another 5,000 HCPs that we call on that do not participate in an oxybate REMS program and can't write, you know, any of the choices now, the different oxybate products. They don't like scheduled products, you know. They don't have as many patients in their clinic, but it's still a sizable opportunity, and we continue to grow in the breadth of prescribing across that segment of HCPs. So last October, we conducted market research to, you know, take the pulse of what's happening in the HCP community, and the results here: 100% of the HCPs that had experience with WAKIX stated that they would write the same or increase prescribing over the next six months. So their clinical experience, obviously favorable, and intend to continue prescribing new patients when they come in.
In those that were not experienced prescribing WAKIX, over 40% said that they intend to start prescribing over the next 6 months. As I highlighted before, one of the most unique features, you know, driving this outcome was the non-scheduled status of WAKIX compared to the other options in the market: Schedule II stimulants, Schedule III oxybate products, and Schedule IV wake-promoting agents. Turning to our development pipeline. This a snapshot of our pipeline. I think the takeaway is continues to grow, and we've started to diversify it with the acquisition of ZYN002 or the cannabidiol gel. I'm gonna walk you through the highlights of these programs and where we are and what's to come.
So, as I mentioned, we continue to advance the pipeline programs and make good progress, representing about over 100,000 diagnosed patient opportunity if successful. Starting with idiopathic hypersomnia or IH, we announced our top-line data, and importantly, the proof point was in the open-label treatment phase, a high response rate of 83% of patients with a significant reduction, a robust improvement in EDS as measured by the Epworth Sleepiness Scale. So, during the randomized withdrawal phase, you know, did not hit on the primary outcome, but the totality of the evidence and the data, we feel that, you know, there's a strong case to be made, the overall benefit-risk proposition, and there's only one approved product for IH in the market being Xywav.
So, as I mentioned, we submitted a meeting request, and we'll be meeting with the agency later this quarter. Prader-Willi syndrome. Clinically meaningful improvements seen in both EDS and behavioral symptoms in the phase II proof of concept study. Good interactions with the agency, agreement on a design of a pivotal phase III trial that we are on track to initiate later this quarter. Myotonic dystrophy, as I said in December, top-line data readout, strong signals in not just EDS, but fatigue, which is an important sort of symptom in many neurologic disorders, which opens up another path of you know, investigation for pitolisant or importantly, the next generation, next-gen pitolisant formulation. So we continue to review all the data and, you know, make decisions about how to optimize that program.
Pediatric narcolepsy, based on the good work of our partner, Bioprojet, they conducted a pivotal phase III trial in patients with pediatric patients with narcolepsy. It was a positive study, and it led to the approval of WAKIX in the E.U. last March for EDS and cataplexy down to age six. We've worked with our partner, submitted an sNDA late last year, and we'll be engaging with the agency on the potential pediatric indication. Switching gears to how do we extend this franchise of a very innovative molecule with a novel mechanism of action and a successful product in the market, and how can we optimize the life cycle? So we've been working with our partner, Bioprojet, on new formulations to achieve that, and just very at high level. So I'm gonna start with formulation 2 in this slide.
This is a very opportunistic approach, fast-to-market strategy during the WAKIX life cycle, modify the formulation, some opportunity with new data for clinical differentiation in an abbreviated development program, in a bioequivalence approach in narcolepsy, and come to market during the WAKIX life cycle. We're in the clinic, and first half this year, we'll have data readout. But more importantly, in terms of the value driver, is this formulation one on this slide. And this is really the opportunity to extend the franchise beyond 2030, out beyond 2040, with a truly novel, enhanced formulation of pitolisant to optimize the PK profile, generate new IP, and then look at higher dosage strengths, which can improve upon the efficacy signal in a product that has a very well-tolerated and safety profile.
This is a full development program to come to market at the end of the WAKIX life cycle, and then really to explore not just narcolepsy indication, but additional indications. You know, and one example is our program in DM1, where we could pivot that to a new formulation and then have a lot more runway and a lot more value, if successful there. And again, we'll have pilot PK looking at several different formulations to identify the optimal formulation and take that forward. Turning to our acquisition of Zynerba Pharmaceuticals last October, really excited about this opportunity. So potential new therapy for rare neuropsychiatric disorders. So with regards to our experience in orphan rare neuro, this is sort of an adjacency, a very good strategic fit, favorable deal terms, and bringing in two late-stage products. So what is ZYN002?
It's the first and only pharmaceutically manufactured synthetic cannabidiol, devoid of THC, so has the opportunity to be a non-scheduled product like WAKIX is. You know, we view this similar to pitolisant as another portfolio and a product opportunity with multiple indications. And as I said, it's in phase III for Fragile X syndrome and a phase III-ready program in 22q. This is a patent-protected permeation-enhanced gel for transdermal delivery, so offering benefit over oral cannabidiol products, mainly around the GI tolerability challenges of those oral products. Large safety database for an orphan rare disorder, over 700 patients that Zynerba had been, you know, investigating in the various trials, some of whom have been on the product for over 6 years. And this has patent protection through at least 2040 for the treatment of Fragile X syndrome.
So as we diversify, let me just some highlights of these conditions. Namely, as you see, both of them represent 80,000 patient market... diagnosed patient market opportunity, each one, which is the same size as the diagnosed narcolepsy market opportunity. So Fragile X, a rare neuropsychiatric disorder, which is, you know, the leading known cause of inherited intellectual disability and autism spectrum disorder. It's caused by a mutation, the FMR1 gene, and that causes dysregulation, dysfunction of the endocannabinoid system, which is where the mechanistic fit with CBD working at CB1 receptors is the sort of the rationale for this treatment approach. It results in cognitive and social behavioral symptoms, and the focus on the behavioral symptoms and improvement in the phase III program, and there are no FDA-approved treatments.
It's sort of a similar opportunity on the right in 22q, another rare genetic disorder. There's midline sort of anatomic abnormalities, but mainly the behavioral symptoms and learning disabilities early onset in this patient population. This is on the heels of a phase II trial that Zynerba conducted, open-label data, but positive signals that they started working with FDA. You know, we have stepped in and discussing the trial design and primary outcomes for a single pivotal phase III trial in that opportunity. So as I mentioned before, you know, part of sort of the fabric of Harmony has always been, you know, disciplined capital allocation, looking to maximize shareholder value. Sort of summarized on this slide, so our profitability and cash generation, you know, gives us the financial strength and flexibility, how to deploy the capital.
And it's not either/or, and fortunate, you know, to, to be in this position. So first, business development, a high priority for us, to drive long-term growth and value, and also, you know, to build out the pipeline. We have a dedicated business development team that's been at the meeting, has been very busy, meeting with, you know, lots of, different parties as we are active in the space and, you know, looking to, really grow the pipeline. Our focus is on, you know, rare neurologic diseases, neuropsych disorders, adjacencies with unmet medical needs. Our, our preference, given our current profile, is, you know, late-stage assets, mid to late stage, but we look at all stages, and for the right opportunity, would consider an earlier stage asset.... something potentially on market, or more transformational.
So we sort of, you know, we look at all of them. Return of capital. As I mentioned, the share repurchase program last year, 3.2 million shares, $100 million, with remaining authorization of $150 million in that program. We'll take an opportunistic approach of how to maximize shareholder value. Again, the takeaway message is, it's not either/or, but we have the financial strength and the ability to execute on both of these strategies. So with that, I think just in closing, looking at Harmony in 2024, I think the takeaway is that we continue to be a growth story. Growth in our core business of WAKIX in adult narcolepsy, advancing and diversifying our pipeline, and growing those programs towards new indications.
And then, you know, actively pursuing business development to expand the pipeline, diversify the portfolio, and obviously, continued opportunistic execution on the share repurchase program. We're excited for these opportunities, and I'm glad I had the opportunity to share that with you. And with that, thank you for your attention and your interest in Harmony. I'll now introduce our CFO, Sandip Kapadia, and Chief Medical Officer, Kumar Budur, to join me for the Q&A. Thank you.
Thank you, Jeffrey. Maybe I'll start off with, like, a few questions. What would be some of the key milestones that we should look forward to in 2024?
You know, so I think, as I mentioned, the key milestones starting off with the next gen, you know, new formulations of pitolisant, you know, with the opportunity of extending, you know, the pitolisant franchise, you know, as something that we're looking forward to and, you know, and excited about. You know, also initiation of a Prader-Willi, you know, pivotal Phase III program there. And another important event and milestone for that. We have the meeting with the FDA around the IH development program. Important readout there. And I think also the sNDA for pediatric narcolepsy that we'll be engaging, you know, with the agency on.
Great. Just going back to the different formulations for pitolisant, so, what could we expect in terms of expansion opportunities there?
Sure. Kumar, would you like to answer that?
Yeah, sure. Hope everyone is able to hear me. Thank you for the question. Yeah, we have been working very closely with our partner, Bioprojet, on the development of the next-gen formulations. Good news is, we have made a lot of progress, and both of these formulations are in the clinic, and we anticipate data within the first half of this year. With the first formulation, it's really a fast-to-market strategy to have one more option for patients, adult patients with narcolepsy. This is an abbreviated development program, a modified formulation utilizing a 505(b)(2) pathway. But the real opportunity is with the next formulation, which is an enhanced formulation of pitolisant, with an opportunity to go to a higher dose strength.
This provides us an opportunity to have a new IP and therefore a long runway, and gives us an opportunity to pursue certain indications that we may not be able to pursue because of limited patent runway with WAKIX. For example, myotonic dystrophy. We announced top-line data last month. Very pleased with the strong signals in excessive daytime sleepiness and fatigue. And we'll also look at exploring other indications, potentially like fatigue in narcolepsy, which is an indication with high unmet need.
Great. And then in terms of time to market, what timeline are you looking at for the new formulation to be available?
Yeah, the first formulation will be within the life cycle of WAKIX. So this is an additional opportunity for patients, adult patients with narcolepsy. With the second formulation, we anticipate it to be towards the end of life cycle of WAKIX.
Great. In terms of DM1, you briefly touched on it during the presentation. Could you maybe highlight the next steps for the program?
Yeah, sure. I mean, Myotonic dystrophy, as you know, 40,000 patients, a disease with high unmet need. Whenever people think about Myotonic dystrophy, they almost always think about the myotonia, that is the inability to relax the muscles. But what is important is these patients have excessive daytime sleepiness and fatigue. In fact, 80% of the patients have excessive daytime sleepiness and fatigue, and clearly, they mention that these two symptoms are the symptoms that are im-- that adversely impact their life. From the phase II study perspective, as we mentioned earlier, really excited to see that pitolisant improved both excessive daytime sleepiness and fatigue. We are still evaluating the data. We just reported the top line. We, the other important aspect is the safety profile of pitolisant in Myotonic dystrophy.
Despite the fact that these patients have significant comorbidities, the safety profile of pitolisant was consistent with the established safety profile of pitolisant. At the appropriate time, we will interact with the regulatory agency, but also, as I mentioned earlier, we might pivot this program towards one of the next-gen pitolisant formulation.
Great. And then one last question maybe on the pipeline would be, you did mention that there is a pending FDA meeting request for IH. What is your level of confidence in finding a path forward for that program?
Yes. Yeah. For idiopathic hypersomnia, we are optimistic that we will be able to find the most efficient pathway to bring pitolisant for patients with idiopathic hypersomnia. And the reason I say this is that's based on the totality of the data, what is available for patients with idiopathic hypersomnia, and the current treatment paradigm. If you look at the totality of the data, Jeff touched upon this quite a bit in his presentation. In the open-label part of the study, 83% of the patients, that's almost eight out of ten patients, responded to pitolisant with a decrease in ESS score of greater than or equal to 3, which is 50% higher than what AASM considers as a response. Not only that, the magnitude of efficacy was also pretty significant.
A drop by 9.4 points, which means that most of the patients who entered into this study had moderate or severe excessive daytime sleepiness. But by the time, the end of the open-label period, most of these patients had an ESS score of less than 10, which is considered as normal. Within the randomized withdrawal period, granted that the primary endpoint did not meet statistical significance, there were several other key endpoints, such as Idiopathic Hypersomnia Severity Scale, which actually looks at the gestalt of the idiopathic hypersomnia. The other scale, such as Sleep Inertia Questionnaire, which is a very important symptom in patients with idiopathic hypersomnia, and PROMIS-SRI, they reached statistical significance.
In the long-term extension study, almost 9 out of 10 patients who completed the randomized withdrawal period elected to participate in the long-term extension study, and about 86% of those patients are still in the long-term extension study. We are collecting not just the safety data, but also the effectiveness data from those patients. The totality of the data strongly supports pitolisant, and on top of it, the safety profile, again, was consistent with the established safety profile of pitolisant, and we did not see any new safety signals. This, in the context of what is available, which is Xywav is the only drug that is approved for idiopathic hypersomnia. The dosing regimen is suboptimal. It is Schedule III drug with REMS.
And other than Xywav, more often, clinicians utilize Class II scheduled drugs, such as, amphetamines and methylphenidate, which themselves have their own issues like abuse, tolerance, misuse, diversion, and cardiovascular risks associated with it. So based on the benefit-risk analysis, we are very optimistic that we will be able to have a meaningful dialogue with the FDA and able to identify an efficient pathway to bring pitolisant to patients with idiopathic hypersomnia as soon as possible.
Great. Thank you. Just going back to the overall business. The business has grown quite well in the past five years. Can you maybe break down where you're seeing that growth come from?
Yeah, sure. I'll start, Sandip, if you want to comment. I think, you know, highlighted by one of the slides I showed, you know, the growth. It starts with a big market opportunity in terms of even though it's an orphan rare disorder and then the differentiated, you know, product profile and the broad clinical utility. So growth is, you know, coming from the different segments of prescribers on that slide, 4,000 HCPs in the oxybate REMS, and we continue to see the depth of prescribing new prescriptions coming there, and the breadth in the 5,000 HCPs who don't participate in the REMS and new patients coming, you know, there. So I think it's the broad clinical utility, the opportunity that remains in the narcolepsy market. Sandip, anything to add?
No. No, I think, I think you kind of covered it.
Okay.
Great. Then just going back to the acquisition of Zynerba, you brought in Zygel. Could you please highlight what was interesting about this asset, and the broader opportunity?
It was interesting in a lot of ways. I think it was, you know, deal terms, and Sandip can, you know, share those, really favorable. Strategic fit for our pipeline and our expertise, you know, a lot of expertise in-house in rare neuro, neuropsych. And bringing in two late-stage clinical programs, you know, in terms of diversifying the portfolio. And we have been watching Zynerba for about two years, you know, with regards to the progress they were making, and then saw the right time. You know, from a deal perspective, Sandip, you wanna-
Yeah, no, I think it was a very good deal. We had an upfront of about $60 million for, again, like two advanced phase programs. You know, and the rest of the terms were more back-ended based on success. So we feel, you know, it was a good transaction for us as a company, and we'll certainly provide further color, you know, in terms of enrollment and, you know, potential readout, in the, you know, potentially at the next quarterly earnings call.
Yep.
Great. Then just, like, trying to understand, given your financial strength, how should we think about your capital deployment priorities in the coming years?
Sure. Sandip?
Yeah, no, I think, look, we have as a—you know, we have a strong underlying business, as Jeff showed. We have great top-line performance. We have highly profitable and generating significant cash and robust cash overall, and we're always looking for ways to, you know, provide shareholder returns. And two of the ways is sort of Jeff shared. You know, one is clearly through business development and looking for opportunities that can help leverage the great capabilities that we've built up, both from a commercial perspective, as well as R&D perspective. But another way that we've also executed on is through share repurchase. This past year, you know, this past quarter is actually a good example. We completed the Zynerba transaction. We spent $60 million for that.
We completed $50 million in share repurchase just during the quarter and, you know, and still ended the quarter with north of $400 million in cash. So we are in a solid position to continue to and look for opportunities to provide return for shareholders.
Great. We have just a minute left, and maybe for the last question. This is the first time that you are providing guidance. Can you help characterize that for investors?
Sure. I think, you know, the way we look at it is, it is our first time that we provide a revenue guidance. As Jeff mentioned, $700 million-$720 million. You know, we looked at it as a very thoughtful and balanced approach in terms of guidance. It was our first time out. You know, we took into account, we had very strong momentum coming out of last year with almost 33% sales growth. And, you know, the $700-$720, in terms of the guidance, would represent another year, basically fifth year on the market and more than double-digit top-line growth and performance. So we're very pleased with the opportunity to provide at least investors with, you know, our initial thinking on there.
Having said that, guidance is an ongoing process, and certainly every quarter, as we have success in our business, we'll continue to provide an update there. And, you know, certainly our opportunity is to continue to exceed overall. But I think importantly for investors, I think the guidance also represents what we've been saying for quite some time, that WAKIX is a $1 billion+ opportunity in narcolepsy alone, and we are well on our way to achieving that. And in addition, if as we have success in our pipeline programs, you know, we have the potential to add potentially another $1 billion in terms of top-line revenue potential through some of these opportunities.
So, you know, we're very pleased to provide the guidance, but generally, we're even more pleased with certainly the long-term outlook for the business.
Yeah, and I would just add, it also signaled our continued confidence in the business, you know, from the management team and the organization. You know, the other reason. But I think Sandip captured that well.
Yeah.
Great. Thank you so much.
Thank you, Sanjibita.
Thank you.
Thanks, everyone.
Thanks, everyone. Thank you.