Good morning everyone and welcome to HC Wainwright at Home, our virtual Fireside Chat series. I'm Patrick Truccio, a Senior Healthcare Analyst at HC Wainwright. Today we're joined by Jeffrey M. Dayno, President and Chief Executive Officer, Kumar Budur, Chief Medical and Scientific Officer, Sandip Kapadia, Chief Financial Officer, and Adam Zaeske, Chief Commercial Officer of Harmony Biosciences. Harmony's commercial franchise is anchored by Wakix or Pitolisant, the first and only FDA-approved non-scheduled treatment for narcolepsy, which is on track to generate revenues of $714 million in 2024 and $870 million in 2025 by our estimates. With next generation pitolisant formulations, gastro-resistant and high-dose, advancing and franchise well positioned to surpass $1 billion in annual revenues by 2030. Harmony continues to execute commercially while investing in life cycle innovation.
In parallel, the company is developing ZYN002, cannabidiol gel in Fragile X syndrome or FXS, with pivotal Phase 3 RECONNECT data expected mid-year, and EPX100 in Dravet syndrome and Lennox-Gastaut syndrome, both in Phase 3 with top-line data anticipated in 2026. Harmony also recently presented preclinical data for BP115205, an investigational orexin-2 receptor agonist, at the SLEEP 2025 meeting, highlighting dose-dependent wake-promoting and cataplexy-suppressing activity in a mouse model of narcolepsy. We look forward to discussing these late-stage catalysts and the company's long-term growth strategy in more detail today. Maybe just to start, if you could walk us through the Harmony story, how the commercial and pipeline pieces come together and where you're focused in the near term.
Yeah. Good morning Patrick. On behalf of the Harmony team, thanks for the invitation this morning. I appreciate your opening remarks. I think you framed kind of the Harmony story really nicely. I think that top line sort of takeaway that Harmony continues to be a growth story is supported by the continued growth of Wakix in the market for patients with narcolepsy, really based on the strong underlying business fundamentals. It continues to grow, as you mentioned, on its way to a billion dollar plus opportunity in narcolepsy alone. From there, as you've highlighted, we have built out a robust late stage pipeline with multiple near term catalysts that we're very excited about. Let me just frame that pipeline as you were sharing. It now consists of three orphan rare CNS franchises with each of those franchises having potential peak sales opportunities of $1 billion to $2 billion each.
We now have, as Kumar will expand on, eight assets across 13 development programs and up to six of them in Phase 3 by year end. If we take a step back, we look across the industry, we feel we have one of the strongest pipelines across the industry for patients living with rare neurological disorders. With that, we've built a unique company profile. We are a profitable, self-funding biotech and really all of this activity is funded off of the balance sheet. Now over $600 million on the balance sheet. We are excited about continued growth of our commercial business, next gen formulations of pitolisant that we'll talk about, and across the pipeline and the near term catalysts that are coming. I'll highlight the one that's right around the corner, ZYN002 in Fragile X syndrome.
I think that's a high level view of continued growth and opportunities ahead for Harmony and towards long term value creation.
Great. A big catalyst this year is upcoming with this top line data readout for ZYN002. Maybe you could just sort of frame the timing for that readout and then as well what a successful trial would look like.
Sure, go ahead, Kumar.
Yeah, Patrick, thanks for the question. Good day everyone. Yes, ZYN002 top line data this quarter is a major catalyst for Harmony Biosciences. In fact, it's not a major catalyst just for Harmony Biosciences. I would go as far as and say it's a major catalyst for patients with Fragile X syndrome, the patients, the caregivers, and the providers in general. Because this will be, if the data is positive, this is going to be the first and only approved treatment for any symptom domains in patients with Fragile X syndrome. We are very excited about this, Patrick, mainly because we have a high level of confidence and conviction in this program.
As we have said before, what we are trying to do in our Phase 3 RECONNECT study is essentially replicating the statistically significant and clinically meaningful data that we saw in patients with complete methylation in the large Phase 2/3 CONNECT study. In terms of your question regarding what does success look like, obviously statistically significant data on the primary endpoint, which is social avoidance, and it's the same endpoint that we used in our Phase 2/3 CONNECT study, and clinically meaningful data in general, a 3 point within-patient change is considered as clinically meaningful. That's what we saw in our CONNECT study, and we are confident that we'll be seeing that in our RECONNECT study as well. The product profile itself is another major differentiation, a very important attribute of this program.
ZYN002 applied as a topical gel provides a really nice alternative for the usual treatment options, which is basically off-label use of many drugs in these patients, to have something especially because these patients have swallowing difficulties. The topical application also negates a lot of the safety and tolerability issues that are often seen with oral administration of cannabidiol.
Right, can you walk us through the most important design changes that were made relative to the Connect Phase 2/3 trial?
Yeah, absolutely. The target population is patients with complete methylation. What happened in the Connect study? It was a large study, by the way, over 200 patients and about 80% of those patients had complete methylation. In those patients with complete methylation, the data was really strong. In fact, those were some of the strongest data sets ever generated in patients with Fragile X syndrome. It all makes scientific sense because patients with complete methylation have almost complete silencing of the FMR gene, which means that they hardly have any FMR protein, which causes endocannabinoid dysfunction. ZYN002, by working with CB1 receptors, resets the endocannabinoid homeostasis. That's one thing. The target population is patients with complete methylation. The primary endpoint is the same.
A couple of changes that we did make based on the learnings from the Connect study is we increased the duration of the study from 12 weeks to 16 weeks. That's mainly because patients continue to get better towards the last four weeks. Given the mechanism of action, it makes sense that the patients do continue to get better for a period of time. The other thing that we did, Patrick, is we increased the dose in patients who weigh more than 50 kg because based on the pop PK, we saw that there was room for us to go higher on the dose in patients who weigh more than 50 kg without compromising on safety and tolerability, because ZYN002 safety and tolerability profile is very benign. Lastly, we also made the study much more patient and caregiver friendly, mainly because we know how to run orphan disease trials.
That's all we do here at Harmony Biosciences. We definitely had a lot more resources here at Harmony compared to the previous sponsor of the study.
Right. In terms of the timing for the readout, do we have a sense of when we may have the data and then the path forward, once we have the data, what does that look like? Would you file for approval immediately? How does this look in terms of the approval and then the eventual launch, and maybe you could even talk through that a bit as well.
Yeah, sure.
The top line data will be available this quarter, Patrick, and if the data is positive, obviously we will immediately rush to submit an NDA. Given the nature of the disease, given the unmet need and the fact that there are no other approved treatments in this indication, I think it's fair to expect a priority review from the FDA. If things go well as planned, we should have a drug approved for these patients by the end of next year, end of 2026. In terms of the commercial launch and preparations, I will have Adam, my colleague, answer that question.
Apologies, can.
You repeat the question just in terms of the commercial expectations, preparations for commercial launch, and how we should think about the product profile? I mean clearly the unmet need is very, very high. Just how you're thinking about that commercial launch?
That's right. I mean it's a significant market opportunity as was mentioned, with 80,000 patients, and you know, these patients suffer from a variety of different symptoms, not only the behavioral, but also cognitive as well as physical. We believe that profile, our compound ZYN002, is uniquely positioned and has the potential, as was discussed, to be the first and only treatment approved. We believe that the studies that we're conducting will demonstrate the value, the risk benefit profile in a manner that will directly address unmet patient needs. We're really excited about the opportunity. The commercial organization right now is mobilizing in preparations for launch with a number of different activities, everything from formalizing our marketing strategy, developing our go to market model, building our sales force, planning our payer access and pricing strategy. We have great confidence that we'll be able to launch with success.
Right, terrific. Maybe just shifting gears here a bit to capital allocation. Harmony's built up this neuro rare disease pipeline over the last several years and has over $600 million on the balance sheet. I'm wondering what the capital allocation plan are for 2025.
Yeah, Sandip, yeah, I think, look, we continue to be relatively active on the business development front. I think one of the things that we've always talked about is looking to continue to build out our pipeline. As you know, we're in a very unique position as a company with positive cash flow generating, you know, as you mentioned, over $600 million on the balance sheet. We really have a lot of flexibility as well as given our profitability, we have more flexibility to continue to add to our portfolio. We're looking at our assets, both early stage as well as potentially on market, all in the neurospace overall. Either it's going to be to help broaden out our Sleep Wake franchise or to continue to grow the neurobehavioral or epilepsy franchise as well. Maybe Jeff, do you want to talk a bit more about the opportunities?
Yeah, no, I think Patrick, as Sandip mentioned, we feel like from a business development perspective, we're just getting started with the opportunity we have based on the strong balance sheet. I think what we've demonstrated is thoughtful strategic build out of the pipeline with our foundational Sleep Wake franchise, the neurobehavioral franchise, and a late stage rare epilepsy assets from the Epigenix acquisition. We look to either go deeper, as Sandip alluded to, in either of those three franchises, or if there's something compelling, potentially an adjacent orphan rare sort of neuro opportunity or possibly go even larger. I think as we grow we have the capacity to do that.
The opportunity, Patrick, is with our unique commercial model, you know, we're positioned where we could leverage that, such as with Fragile X and Adam was saying the go to market strategy, we could leverage, you know, the internal, the infrastructure, our single, our patient hub, closed specialty pharmacy distribution system. These indications, you know, are kind of a centers of excellence model. It's not a big incremental spend to sort of go to market with, you know, either of these opportunities. We continue to be very active and in fact, you know, we recently entered into a small research collaboration with another company called Cirq Biosciences, which is actually a very interesting and exciting opportunity. This is a regenerative medicine company that's developing novel therapies based on reprogramming cells, cellular reprogramming, and has the potential to replace lost cells and restore function. We are focused on serious neurological disorders.
The platform is based on chemically reprogramming cells and it's using allogeneic off the shelf readily sourced GMP cell lines rather than using stem cells with this application. This could enable a significant competitive manufacturing advantage if this platform proves to be successful. This research collaboration is strategically aligned with Harmony Biosciences' pipeline because we're focusing on kind of a novel regenerative cellular therapies for either refractory epilepsy, that's one of the programs in terms of GABAergic cells, or potentially treatment resistant narcolepsy and looking to generate orexigenic cells. The collaboration with Cirq Biosciences would expand our pipeline programs, obviously add to an earlier phase discovery program focused on either epilepsy or Sleep Wake, and this could represent the next generation of innovative disease modifying therapies to address conditions with high unmet medical needs. Early discovery phase, very strategically aligned with our pipeline and another unique opportunity for us.
Let me have Sandip, in terms of the economics. He can share some of the economics of this research collaboration.
Yeah, it was a relatively low upfront overall, as Jeff mentioned, fairly early in development. We paid a $15 million upfront for research to begin the research collaboration. We'll recognize a portion of that as an IP, R&D charge in the second quarter as we signed it a couple of weeks back. Obviously, as the programs move forward, we'll have the option to acquire the programs and take them into the clinic. If successful, that'll be about $10 million each for each of the programs. If we decide to do so, we'll have some customary downstream milestones and royalties. We'll share a bit more about it at our next earnings call. I think overall just stepping up in terms of, you know, we have a very strong balance sheet, over $600 million as I mentioned.
We're well positioned to continue to look for opportunities both early phase as well as mid stage, late stage as well. We have, as Jeff mentioned, a dedicated business development team that's very much focused on looking for some of those opportunities. This one is just one step along the journey.
Right, that's really interesting. Is there an expected timing as far as moving programs forward, or would you have more to say on this at a later date?
Yeah.
Patrick, it's still early. It's still early and we'll provide more color on the upcoming earnings call, and then, you know, as this platform moves forward. Kumar, obviously, you know, leading on our end with the team at Cirq Biosciences, but it's novel, it's interesting, it's a different approach to cellular replacement therapy using chemically, sort of reprogrammed fibroblasts. We will, you know, we'll share more as this opportunity moves forward.
Terrific. Maybe just shifting gears onto Wakix. Wakix grew 20% in the fifth year on the market in 2024, and in 2025 the guidance calls for $820 million to $860 million in revenues. Can you describe the commercial trends and market dynamics that are driving this continued growth in what is now the sixth year of the launch?
Yes. Thanks, Jeff. Thanks for the question. You know, we've seen Wakix deliver remarkably strong and steady results actually since launch and continuing to add patients quarter on quarter in a steady drumbeat. That's quite impressive. We're very pleased with the Q1 results that we announced, achieving $184.7 million in net sales and as you mentioned that's a 20% increase from the prior year first quarter in the sixth year of launch. Really strong steady growth and that is based on the fact that Wakix is a highly differentiated product as the first and only non-scheduled treatment option for patients with narcolepsy. Wakix, having been on the market now several years, we have high awareness with physicians and that includes all 9,000 physicians that are the prescribing universe for narcolepsy patients.
4,000 of those are oxybate REMS-enrolled HCPs, but there's another 5,000 that are not enrolled in an oxybate REMS program and that's a unique opportunity for us and for Wakix that we continue to penetrate. We've seen consistent steady growth. We achieved 7,200 average patients on therapy as of the first quarter, again another solid increase from prior quarters. We have broad payer coverage with 80% of lives covered. We have a very experienced team with many of our commercial folks having been part of the Harmony Biosciences story since its inception. We have a very unique commercial model with a single patient hub, three specialty pharmacies, closed distribution, white glove service that we believe provides a lot of value for HCPs and for patients. Yes, we remain highly confident in our guidance of $820 million to $860 million for the year.
We're also confident that we are well on our way to achieving $1 billion in narcolepsy revenue alone prior to LOE.
Right. Can you tell us what does the guidance embed with respect to patient growth for the full year, and how does that compare to prior years?
It's very consistent with prior years in terms of patient growth. We expect to continue to see the types of additions in patients, average patients that we've seen in previous years actually since inception, and we expect to approach nearly 8,000 patients by the end of the year. This is a large market with significant unmet need. 80,000 patients diagnosed, potentially another 80,000 undiagnosed. With Wakix at 7,200 average patients in Q1, there's still a tremendous opportunity to continue that growth. Wakix is, as I said, physicians are highly aware, highly comfortable with Wakix. They view it as well tolerated, as low drug-drug interactions. We see continued potential for penetration and the addition of new prescribers as we continue to grow and move forward.
Great.
When we think about the lifecycle management strategies under development, I'm wondering if, at a high level, you can discuss where you see both the gastro-resistant and high-dose formulations fitting into the Wakix franchise?
Jeff, would you like me to take that?
Yes, go ahead, Adam, please.
That's great. All right, Patrick, thank you for the question. We have two Wakix or pitolisant life cycle formulations that we're really excited about. The first is the GR, the gastro-resistant coated formulation of pitolisant. This is a fast to market strategy with PDUFA expected in 2026 and also utility patents filed through 2044. It really allows us to expand and extend the franchise. The gastro-resistant coating, it's important to note that 80% of narcolepsy patients continue to struggle with GI symptoms. The GR coated pitolisant formulation, we believe, will help mitigate that need for patients. Not necessarily Wakix GI issues, which are relatively low, but actually the comorbid GI issues are a function of the disease. It's also a formulation that will require no titration. Patients will start immediately at the 17.8 milligram therapeutic dose, which we think is important for patients and securing faster outcomes.
The strategy for GR will be to launch it as an inline extension and we'll be seeking to start new patients that would have been prescribed Wakix on pitolisant GR. We also have the ability, because of our unique commercial model, to look at patients that may have previously been on Wakix therapy but have discontinued and to communicate with them to ask if pitolisant GR might be an appropriate option for them as well. It's really new patient adds as well as potentially previous patients. Now, the HD, that's the high-dose. This is also really exciting. We have a formulation that will also have the GR coat, will also have the no titration schedule. It'll be up to a two times dose and we're pursuing a unique indication in terms of fatigue. We know that 60% of narcolepsy patients continue to struggle with fatigue as a symptom.
We also know that 75% of patients continue to struggle with residual symptoms in general. We believe the HD can deliver a better therapeutic outcome. The PDUFA is 2028 and this formulation also has utility patents filed through 2044. The high-level strategy on the HD is all new Wakix patients starting on this formulation as well as previous patients and also transitioning current Wakix patients to this new formulation. We've tested this in market research. We have very favorable response from both HCPs and payers. HCP is indicating they would start all new Wakix patients on pitolisant and high-dose as well as transition the majority of current Wakix patients to this new formulation from a payer perspective. Also a very positive response prior to LOE. No step required through Wakix even post LOE.
The only potential step might be patients that have never had any Wakix experience in the last six or by the time we launch eight years. As we know, even though we're at 7,200 average patients in the first quarter, there's many more patients that have been on Wakix therapy before. That look back for the step, the potential step edit probably is a relatively small population.
Right. Just a follow up on the high-dose formulation in particular. What would you see as a potentially clinically meaningful benefit versus Wakix?
Yeah, Patrick. The high-dose formulation is designed based on what we know about pitolisant. We have talked about this in the past. The dose range was never really fully interrogated when it came to pitolisant original pivotal clinical trials in narcolepsy. We have a body of evidence to show that there is dose response, exposure response evidence for pitolisant. We here have an opportunity to extract larger efficacy on the core symptoms like excessive daytime sleepiness and also target symptoms like fatigue that Adam was just mentioning without compromising on the safety and tolerability of pitolisant. In fact, we actually completed a Phase 1B study where we looked at pitolisant all the way up to 180 mg in a repeat dose study. The safety and tolerability profile in general was consistent with the established safety and tolerability profile of pitolisant.
Larger efficacy, target unique indications, and no compromise on the safety and tolerability. This is the kind of target product profile we are looking with our pitolisant HD.
Right. When you speak with payers in the high-dose profile, what are they looking for to support moving to the higher dose? Is there a specific magnitude of benefit or endpoint that they're focused on?
Yeah, thanks for the question. As I mentioned, we did do some extensive payer market research and we're updating that now. We did test different profiles based on the profile that we expect for the HD. That's where the response was very clear that there'd be favorable access for the HD formulation. As I mentioned, no step edits through Wakix prior to LOE and even after LOE, a potential step edit, but only for patients that have never had any experience on Wakix, which, as I said, is a relatively smaller population.
Right.
Last year, you know, acquired an orexin-2 receptor agonist. I'm curious, just following Takeda's positive Phase 3 readout, how you see your program positioned relative to others and what aspects of its profile could offer meaningful differentiation.
Timur, do you want to comment?
Yeah, sure. Patrick? Yes, we are aware of Takeda's top line data readout from both of their Phase 3 studies, which is good. We are happy about it. It's a new class of innovation for patients with narcolepsy. This will provide another treatment option if the drug gets approved by the regulatory agencies for patients with NT1. We look forward for additional data at the future congresses from Takeda's compound. In the meantime, Patrick, we are making all efforts to advance our own orexin-2 receptor agonist. We presented the full comprehensive preclinical safety and efficacy data at the recently concluded sleep meeting last month in Seattle. We are on track to initiate first in human studies later this year and share some clinical data next year. What we are excited about with our orexin-2 receptor agonist is the product profile based on the data that we have generated thus far.
It continues to be the most potent orexin-2 receptor agonist compared to anything else out there, based on the data that is disclosed in the public domain. We always focused on potency and we said potency is important because that gives us the dosing flexibility to target all three central disorders of hypersomnolence, NT1, NT2, and IH. The reason for this statement is based on the data that we have seen so far, patients with NT2 seem like they need a slightly higher dose than NT1 and patients with IH need a larger dose compared to NT2. Having one of the most important orexin-2 receptor agonists gives us the ability to tolerate all these three indications without going too high on the dose.
Not only that, good selectivity, a relatively clean preclinical safety profile, and the ability to dose once a day is what we are excited about with our orexin-2 receptor agonist. Of course, when it comes to clinical trials, we know the sites, we know the principal investigators, we have been working with them for almost a decade now. For us to go ahead and run these clinical trials will be a lot easier and we are very excited to get this compound to our sites and investigators.
Yes. I think, Patrick, also in addition, knowing that the clinical trial sites and investigators are known in the market, I'd like Adam, with all his commercial experience, to comment on the dynamic, the prescribing dynamics when a new class of therapy, the excitement, and it is a very exciting kind of new target for the treatment of narcolepsy, other essential disorders of hypersomnolence. Commentary of when those agents come to market and how that plays out, our position around that. Adam.
Yeah, so we've seen, and I've seen personally, a lot of examples of new mechanisms of action entering a therapeutic area with significant options already available with high excitement around efficacy. I think we still need to wait and understand the full clinical detail, see the full details of the larger studies as they come out, and also weigh the long-term impact and therapeutic impact, the risk-benefit profile, and, you know, safety and tolerability in the longer term. I think that's how HCPs will typically think of this. Probably see the KOLs and HCPs with larger patient populations selectively trying these compounds as they are introduced and then maybe gradual growth over time. We're excited about the opportunity with orexins as a new treatment option for patients.
We're confident that our own orexin molecule has potential to be best in class, and we believe the impact on Wakix for the introduction of orexins will be limited, at least in the short term after launch. Wakix is highly differentiated. As I mentioned, it's the only non-scheduled treatment option. HCPs will have eight-plus years of clinical experience with Wakix at the time of the launch of these new compounds, so very familiar, high awareness, perceived as well tolerated for a very broad set of patients, low drug-drug interactions. What's also important to note, in narcolepsy there is definitely a polypharmacy approach to treatment, so the majority of patients are on two or more therapies, and we expect that approach to continue. We also know and have evidence that orexin and histamine have a synergistic effect.
We remain confident in the continued growth potential of Wakix even in the light of a new class entering. That's actually what we've seen in the six years since launch. With new brands and generics entering the market, Wakix continues its very steady and consistent growth profile.
Right, that makes sense. You've also acquired an epilepsy asset, EPX100. I'm wondering if you can just provide some background on this compound, why it was attractive, where you see the unmet need in epilepsy, and then we'll have a few follow ups. Sure.
Yeah, go ahead, Kumar. We are very excited about the late-stage epilepsy pipeline, and Kumar can share what we saw in that and where the programs are.
Yeah, thanks, Jeff. Patrick, if we take a step back, a lot of thought and strategy went into our decision to move into epilepsy space because as you know, epilepsy continues to be one of the highest unmet medical needs despite so many medicines approved. Because patients who are currently on various combination of medicines, they either continue to have seizures or they have some safety and tolerability issues. That requires regular monitoring of liver function tests, regularly checking the therapeutic levels of the drugs, because many of these drugs have narrow therapeutic window. What we see in field of epilepsy is even if there is a small incremental improvement in efficacy, safety, or tolerability, this is embraced by patients and the providers alike.
With Epigenix acquisition we saw a really nice opportunity to make an impact in developmental and epileptic encephalopathies, which actually has the highest unmet need compared to epilepsy in general. With Epigenix acquisition we got two compounds, EPX100 which is clemizole hydrochloride, the lead compound, and EPX200 which is liquid locamide formulation which is in the IND enabling stage. With EPX100, clemizole hydrochloride, established mechanism of action when it comes to treating developmental and epileptic encephalopathies. It's a 5HT2 serotonin agonist and the data is very clear that if we increase the serotonergic tone, it helps with seizures in patients with developmental and epileptic encephalopathies. Good preclinical proof of concept data. Currently we are running two pivotal Phase 3 registration studies, one in Dravet syndrome and one in Lennox-Gastaut syndrome. We are making good progress, anticipate top line data in 2026.
The differentiation here, Patrick, is really more on the safety and tolerability perspective. Unlike other serotonergic drug that is approved which requires regular monitoring with echocardiogram, we don't need that with clemizole hydrochloride. There is a body of safety and tolerability data from clemizole hydrochloride which was originally approved as an antihistamine in 1960s and 1970s. We did complete preclinical tox studies where we did not see any issues for concern. The other thing is it also doesn't require regular monitoring of liver function tests, for example like Epidiolex which is also approved for developmental and epileptic encephalopathies for Dravet and LGS. We are looking forward to bring a drug to patients with good efficacy, very good safety and tolerability with no need for any special laboratory monitoring or any special medical monitoring.
Great.
Just a few follow up questions then. Clearly the differentiation should be on the safety and tolerability side. Epilepsy though is also a polypharmacy market. I'm wondering how we should think about potential for combination of EPX100 with other treatments as well. The indications, LGS and Dravet, where are the, what you need to demonstrate in terms of seizure reduction to have a place in those, with those indications and then the potential actually to broaden the label to include additional subtypes of epilepsy and how you're viewing that possibility. I know there's a couple of questions in there, but as we get this phase 3 data, would we start to have some answers to this or how are you thinking about the program going forward?
Yeah, I mean the trial. Great questions, Patrick, because this all have implications on how the drug will be prescribed by the prescribers to the patients. Right. In terms of the polypharmacy, you are absolutely right. I mean any patient currently who has described on average are on about four different medicines, sometimes up to six different medicines, sometimes on label and many a times off label. That's what we are seeing in our clinical trials as well. The clinical trial design itself, Patrick, is very well established. The same design, the same endpoint is accepted not just by FDA and EMA, but other regulatory agencies across the world. In terms of the concomitant medications, we haven't seen any significant drug, drug interactions to the point where we will have to exclude some of the commonly prescribed medicines for Dravet syndrome.
In fact, many patients who come into the trials are actually on these medicines and they still have uncontrolled seizures meeting the severity that is required for the inclusion criteria. It's fair to assume that this will be another option for prescribers to prescribe on top of everything else that the patients are already taking. This again, speaks to the high unmet need in this particular area.
Right, terrific. Maybe just one last one to bring it all together here. I think 2025 has been referred to as a transformational year. I'm wondering what you would like investors to understand or revisit about the Harmony Biosciences story at this point in time.
Yeah, Patrick, I think, as you heard from the team this morning, I think Harmony continues to be a growth story not only in Wakix and narcolepsy, but the advancement of the pipeline. I think that the main takeaway is kind of the value, the potential value of our pipeline programs that are late stage with near term catalysts. In fact, if we look at our existing pipeline, it's poised to deliver one or more new product or indication launches each year over the next four to five years. That's significant. These are late stage programs, as Kumar mentioned, often replicating positive findings from Phase 2 programs designed into Phase 3. I think that is the main takeaway and I think the time is now. We are focused on advancing these late stage development programs.
We are very excited about the Fragile X opportunity with ZYN002 and I think our goal, bringing new products to market, helping these rare disease patient communities with new innovative treatment options while driving long term value creation for our shareholders. That is the story and the time is now with these late stage programs moving forward and on the verge of multiple NDA submissions over the next year or two.
All right, terrific. We look forward to continued stellar growth and late stage readouts as well. It sounds like some very interesting early stage programs as we get this detail going forward. I'd like to thank the leadership team at Harmony Biosciences for joining us this morning and thank everyone for also joining us for this very interesting discussion. Everyone have a great rest of your day and great rest of your week.
Great.
Thank you, Patrick. Thanks, everyone.