Good afternoon, everyone. Welcome to the next session with Harmony Biosciences. I'm Ami Fadia, Biotech Analyst here at Needham. Thank you so much for joining us today. It's my pleasure to be hosting the Harmony team led by Jeff Dayno, who's the CEO, Sandip Kapadia, CFO, and we also have Dr. Kumar Budur, who's the Chief Medical and Scientific Officer. Good afternoon, everyone. Thank you so much for joining. Perhaps if I could just ask Jeff to kick us off with a few opening comments, and we can dive straight into Q&A.
Yeah, sounds good, Ami. First of all, yeah, good afternoon, everyone. Ami, thank you for the invitation on behalf of the Harmony team for this fireside chat to kind of share our story and where we are. I think at a high level, we really, given Harmony's unique profile, Ami, we sort of like our profile, especially given the current market backdrop. I think, namely, and importantly, we're a profitable self-funding biotech company now with generating strong cash from our Wakix commercial business. We ended last year with over $576 million on the balance sheet with regards to, based on the strong cash generation, and also advancing our pipeline off of the balance sheet as well. In addition, I think, as we'll talk about today, we're really excited about the late-stage catalyst-rich pipeline that we built over the past couple of years.
Namely, we have three orphan rare CNS franchises in our pipeline, each with potential peak sales opportunities of $1 billion-$2 billion each. If you look at our pipeline, which we believe is one of the strongest pipelines in the industry currently for patients living with orphan rare neurological disorders. In our current programs, we have eight assets across 13 development programs, and up to six of them in phase III by the end of this year. With this pipeline, it really sets us up to deliver one or more new product or indication launches each year over the coming years.
In addition to our strong cash position, our profitability, our Wakix franchise that continues to grow, and basically on track to reaching a billion-dollar-plus opportunity in narcolepsy alone, and then the strength of our late-stage pipeline, we feel that we're well-positioned to continue to create long-term durable value creation for our shareholders and the potential to help hundreds of thousands of patients living with rare neurological disorders.
Okay, great. Thank you, Jeff. Perhaps if we could start by, I mean, you certainly have built a very nice and deep pipeline portfolio. What is the next most important catalyst in 2025? Acknowledging that we have several coming up.
Yeah. The next most important catalyst for us that we're very excited about is our top-line data readout in the phase III RECONNECT trial, ZYN002, for Fragile X syndrome. I'm going to turn it over to Kumar. Just yesterday, we shared some new data, presented new data at the American Academy of Neurology meetings at a podium presentation, hot topics in child neurology from some open-label extension data from the prior phase II CONNECT study. I think with that data showing kind of our conviction in the probability of success with the ongoing phase III RECONNECT trial. We're very excited about that upcoming milestone. Kumar can share some of the data that we presented yesterday and how we're tracking towards the next catalyst. Kumar?
Yeah, thank you, Jeff. Good day, Ami, and good day to everyone on the call. Yes, Ami, the next major milestone for Harmony is really the top-line data in third quarter of this year on ZYN002 and Fragile X syndrome. In fact, it's not just a major milestone just for Harmony, but the field in general, given that there are no approved treatments for any symptoms in patients with Fragile X syndrome. Jeff mentioned about the podium presentation that happened at American Academy of Neurology meeting yesterday. Just to provide some context, Ami, this podium presentation was under the hot sections, hot topics in child neurology. It was only one of the 10 presentations that was selected for podium presentation. If you put this in context, the American Academy of Neurology typically receives several hundreds of abstracts for presentations. This really underscores two things.
One is the unmet need in patients with Fragile X syndrome. The second thing is the data that was generated on ZYN002 and Fragile X syndrome. What we presented were two things. The first one is long-term efficacy, specifically as it relates to irritability in patients with Fragile X syndrome, which is another core symptom other than social avoidance. We showed that over 60% of the patients showed more than 9-point change in Fragile X syndrome irritability subscale that is considered as clinically meaningful. Over 70% of the patients showed clinically meaningful changes on caregiver global impression scale. Pretty impressive and also durable data, given that we showed this in 240 patients over a period of three years. Of course, the long-term safety and tolerability, where it continues to demonstrate a very favorable safety and tolerability profile.
With the only treatment emergent adverse event of note was application site pain that was reported in about 6%-7% of the patients. This includes irritation, itching, redness, and swelling. Overall, strong data sets, another supportive evidence for our conviction in the ongoing RECONNECT study with the top-line data anticipated in third quarter of this year.
Okay. Yeah, no, I think that this data is certainly very compelling given the long-term follow-up here. Perhaps maybe just remind us with regards to the RECONNECT study, what is sort of the study size? What is it powered to demonstrate in terms of the endpoint? How does it compare to kind of what we had seen previously in the CONNECT study?
Yeah. The RECONNECT study, Ami, this is a phase III pivotal registrational study that is ongoing. As mentioned earlier, top-line data anticipated in third quarter of this year. This study design is something that was aligned not just with FDA, but EMA as well. If the study is positive, we have an opportunity to get approval not just from the FDA, but also from EMA as well. It is a prospective parallel study design, approximately 180 subjects. About 80% of them are patients with complete methylation, and 20% of them are with partial methylation. The primary target population is patients with complete methylation. These are also the patients who have more severe symptoms.
These are the patients where the FMR protein production is virtually absent, which means that their endocannabinoid system is significantly dysfunctional, where ZYN002 acts in a mechanistically synergistic way in the sense it resets the endocannabinoid system and helps these patients with neurobehavioral symptoms. About 65% of the patients with Fragile X syndrome have complete methylation. We are recruiting about 20% of patients with partial methylation with the understanding that if the primary endpoint is positive in complete methylation, and if we see supportive data in patients with partial methylation, then we have an opportunity for a much broader indication for patients both with complete and partial methylation. Eighteen-week treatment, the primary endpoint is Aberrant Behavior Checklist, Fragile X syndrome, social avoidance subscale. We are also looking at several other endpoints, including irritability that we just talked about before.
In terms of your question about the previous phase II -III study, CONNECT study, the learnings from that study, the CONNECT study was one of the largest phase II -III studies that was done in patients with Fragile X syndrome. That study showed both clinically significant and clinically meaningful improvement in several core symptoms in patients with Fragile X syndrome, including social avoidance and irritability in patients with complete methylation. Essentially, what we're doing in RECONNECT study is replicating the clinically meaningful and statistically significant results in patients with complete methylation from the CONNECT study to RECONNECT study. Just looking at the pathophysiology in patients with Fragile X syndrome, the intervention, which basically helps to correct the dysfunctional endocannabinoid system, and the positive data from the CONNECT study in patients with complete methylation, we have a high degree of confidence and conviction in the RECONNECT study.
Yeah. Ami, I think if I sort of pull us back at the higher level of the relevance of this, with no FDA-approved treatments for patients living with Fragile X, and obviously many programs that have failed in the past, this is an opportunity, if we're successful, of bringing the first approved treatment for patients living with Fragile X to patients not only in the U.S., for which there are about 80,000 patients in the U.S. living with Fragile X. For an orphan rare disorder, a significant kind of market opportunity, but also with global rights to ZYN002 and a study design that has been discussed with EMA, as Kumar alluded to, that we could also register in Europe, an opportunity to partner this out in markets outside the U.S. as well.
If we are successful with positive data, then Kumar and the team has also been working on a follow-up indication in 22q deletion syndrome, so another related neurobehavioral disorder, and has already had interactions with the agency in terms of initiating a pivotal phase III trial in 22q deletion syndrome on the heels of positive data in Fragile X.
Yeah. No, that's very helpful, Jeff. Maybe just a quick follow-up on the data that we have from the CONNECT study. Now, the primary endpoint in the RECONNECT study is sort of the social avoidance subscale. Can you talk about what has been the experience in the open-label portion around the social avoidance subscale and then sort of the intertwining of irritability and social avoidance? I guess you guys reported on the irritability sort of subscale. So maybe kind of if you can talk about that, and then also from a clinically meaningful standpoint, how much of a change, whether it's on an absolute basis or relative to the placebo that the physicians would consider clinically meaningful?
Yeah. I mean, social avoidance, social isolation, irritability, these are some of the core symptoms in patients with Fragile X syndrome. In the long-term study, we saw a similar trend with social avoidance as well. These data were presented in the middle of last year at National Fragile X Foundation. The data are very similar and compelling, just like what we saw with irritability. In terms of clinical meaningfulness, a three-point change in the social avoidance subscale is considered as clinically meaningful, and that is well established. The data from the CONNECT study also in patients with complete methylation showed a clinically meaningful change. When I say clinically meaningful change, it's a three-point change from baseline to the end of treatment on social avoidance.
We also saw a clinically meaningful change in the irritability component as well, which is a nine-point change from baseline to the end of the study.
Got it. Okay. Maybe if you could shift gears and talk about one of the other kind of data points that you're going to share with us in June of this year, and that's around the Orexin agonist asset. Can you talk about how it may be differentiated from the ones that are currently in the clinic? You have one of the lowest EC50s compared to some of the others. Maybe kind of talk about, based on some of the preclinical data, how do you see that potentially manifesting in the clinic?
Yeah. We are presenting comprehensive preclinical safety and efficacy data at the annual sleep meeting in the month of June. Really excited about it. Based on the preclinical data, potentially, this could be a best-in-class Orexin-2 receptor agonist . Now, why do I say that? Based on several things. First and foremost is the novel chemical structure. This is not a me-too chemical structure compared to other Orexin-2 receptor agonists . We moved away from the typical pyrrolidone, sulfonamide, bicyclic moiety. The second thing is the potency. As you mentioned, Ami, it has one of the lowest EC50. I mean, we are talking about one-one hundredth of a nanomolar here, 0.05 nanomolar EC50 at Orexin-2 receptors .
This high potency gives us the dosing flexibility and therefore the ability to target all the three central disorders of hypersomnolence at a very low dose, which is NT1, NT2, and idiopathic hypersomnia. It has an excellent selectivity of over 600-fold. This, taken in the context of a potency, really high potency, offers greater than 140-fold margins for Orexin-1 receptors or Orexin-1 receptors at the anticipated maximum human therapeutic dose. That is a lot of selectivity, over 100-fold margin. Not only that, we also showed over 1,000-fold selectivity over at least another 1,500 targets of interest in humans. Also the preclinical data is supportive of once-a-day dosing. The combination of all these factors makes us believe that we potentially have the best-in-class Orexin-2 receptor agonist .
We are on track to submit IMPD in the middle of this year, followed immediately by first-in-human studies. We should anticipate discussing the clinical data sometime in 2026.
Okay. Now, there are a couple of players that are in the clinic and swiftly moving towards generating data that can support pivotal studies. As you sort of watch how they're developing their programs, how does that influence how you might develop your own clinical development plan in terms of either identifying the indications, which I presume you're thinking about the three lead ones, or also the endpoints that you intend to study as you develop your asset?
Thank you, Ami. Look, we see the other Orexin receptor agonists. Everyone is still in early stages of clinical development in phase I-B, phase II-A, with the possible exception of Takeda, where they are in the pivotal registration studies for NT1 only. Everyone is doing good work in a novel class of drugs, which is good for patients with narcolepsy. We are also very excited about our own Orexin receptor agonist as well. We will certainly leverage some of the learnings from others who are already in the clinic. We will be pursuing an accelerated clinical development path, but making sure that we have the right data sets as we move from one phase of development to the next.
Okay. I want to talk about sort of the Wakix franchise or the Pitolisant franchise. Obviously, Wakix is rapidly progressing towards becoming a billion-dollar blockbuster asset. Can you talk about your next-generation program, the rationale behind it? You sort of have generated some clinical data there. What is the next step towards bringing that to fruition and the pivotal data?
Yeah, sure. I mean, let me just sort of set up the strategy then. Kumar can kind of give an update on the progress of the programs. Obviously, Wakix as a novel, Pitolisant is a novel first-in-class molecule that's been a very successful product in the market. What we're looking to do is to take a very good drug and make it even better. In the context of patient-focused drug development, where we're looking at ongoing unmet medical needs in patients living with narcolepsy, namely residual symptoms in over 75% of patients, the need for greater efficacy, especially around excessive daytime sleepiness, is really kind of paramount to drive greater efficacy.
Through our learnings in the market and in the literature, the predisposition to GI symptoms in patients with narcolepsy, not related to Wakix, related to some other medications like oxybates, that 15%-20% of patients with GI side effects, but having a product that could sort of mitigate against some of that predisposition to some of the GI side effects in our Pitolisant GR program.
The thinking is, with these two formulations, Pitolisant GR as a quick-to-market strategy that Kumar will comment on with a target PDUFA in 2026, to sort of expand the base of patients that are on both Wakix and a Pitolisant GR, to set up transitioning the franchise in the 2028 timeframe, the target PDUFA for Pitolisant high dose or Pitolisant HD, which is sort of the main value driver, obviously out ahead of LOE of Wakix in 2030, and with utility patents now filed to 2044 for both Pitolisant GR and HD, which gives us a long runway in terms of completing the development programs, getting in the market, transitioning the franchise, and then really expanding on further development opportunities for Pitolisant HD. I'll turn it over to Kumar on an update of our progress in both of those programs. Kumar?
Yeah. Thank you, Jeff. I mean, Pitolisant GR, fast-to-market strategy showing bioequivalence to Wakix and offering two distinct features. One is patients who have upper GI symptoms. It has a gastro-resistant coating and also the ability to start at the therapeutic dose range. The pivotal bioequivalence study was started in the first quarter, and we anticipate top line from that study in the third quarter of this year. The dosing optimization study will also begin soon. The target PDUFA date is 2026. With the Pitolisant HD formulation, as Jeff was mentioning, the key value driver for the Pitolisant program, here we are going with an optimized formulation of Pitolisant. The data we discussed in the middle of last year, where we showed increase in relative bioavailability and decrease in interindividual variability, both of which have clinical implications.
An optimized Pitolisant formulation with a dose that is up to 2x the highest label dose of Wakix, along with the gastro-resistant coating, to target larger efficacy on excessive daytime sleepiness, which continues to be the most unmet need in patients with narcolepsy, and also target some unique symptoms like fatigue in narcolepsy that is experienced by about 60%-70% of the patients, for which there are no approved treatments. Providing all of these benefits without compromising on the safety or tolerability profile of Pitolisant. Again, we have discussed in the past about the safety and tolerability profile of Pitolisant up to 180 mg in healthy volunteers in multiple ascending dose study, where the safety and tolerability profile was consistent with the established safety and tolerability profile of Wakix formulation.
Two really patient-centric drug development programs, two very differentiated products, both of them launching one in 2026, the other one in 2028, well before the loss of exclusivity for Wakix, which is Q1 2030. With pediatric exclusivity, it will be Q3 2030.
Okay. Maybe just a couple of quick follow-ups on that. With regards to the bioequivalence study for the GR formulation, can you sort of share a little bit more detail around how many patients you need to evaluate it and what is the risk going into that study, just based on the work that you've already done? In other words, what gives you, talk about the level of confidence you have going into the study because you've already formulated it.
Right. I mean, the level of confidence, Ami, obviously high because we did a pilot PK study, pilot bioequivalence study. The data were discussed in the early part of 2024, where the pilot B study showed bioequivalence. Based on that, we designed the pivotal bioequivalence study. In terms of number of patients, just over 50 healthy volunteers participating in the pivotal bioequivalence study. As I mentioned earlier, we initiated the study in the first quarter and anticipating top line in the third quarter.
Okay. With regards to the high-dose program, this is sort of a question that also emerges from some of the on-target efficacy that we've seen with the Orexins, where at a higher dose, you start to see insomnia and some of the other on-target. Of course, this is a completely different mechanism. I guess the question that I'm trying to get at is, at a higher dose, as you have tested up to 180 mg dose, were there any on-target side effects that are worth noting or thinking about, like insomnia and such? Perhaps maybe talk a little bit about that. You mentioned fatigue as another endpoint that's being evaluated. What has been the experience with Wakix with regards to helping with fatigue?
All right. Great questions, Ami. Let's start with the safety and tolerability profile. The common AEs reported by patients on Pitolisant in general. And we have studied Pitolisant extensively, not just in narcolepsy, but as you know, in idiopathic hypersomnia, pediatric narcolepsy, Prader-Willi syndrome, OSA, and many other disorders. The AE profile tends to be consistent, which is the three most common side effects are nausea, insomnia, headaches, and anxiety. This is what we saw with the higher doses of Wakix as well when we studied it in up to 180 mg in a repeat dose study. There might be a slight worsening of some of these symptoms, but up to 5x what we studied, the AE profile was relatively consistent.
With the high-dose formulation, we are not talking about going up to 5x the dose of the highest label dose of Wakix, but we are talking only about going up to 2x the highest label dose of Wakix with an optimized formulation, of course. We anticipate the safety and tolerability profile to be very similar to what we are seeing with our Wakix formulation. That's that.
Fatigue.
Yeah. Yes, fatigue. Thank you for reminding me. I was thinking about that.
Sorry for putting two questions in one.
No, no, that's fine. Fatigue has actually, I'm thinking that maybe I'm having.
The question was.
No, no.
The question was, have you yeah.
Right. No, I was just saying that maybe I'm having some mental fatigue. Fatigue, of course, right? We actually have generated data on fatigue in a couple of contexts. One is myotonic dystrophy. It was an indication that we chose very deliberately because patients with myotonic dystrophy, the primary core symptom is progressive muscle weakness. But about 90% of these patients also experience significant fatigue. In these patients, and we disclosed this data in December of 2023, in these patients, we showed pretty significant impact, clinically meaningful impact on fatigue on fatigue severity scale. We also saw positive impact on fatigue in patients with sleep apnea. This was a study that Bioprojet did, where they were treating residual excessive daytime sleepiness in patients with sleep apnea. We also saw a positive benefit from Pitolisant on fatigue.
Pitolisant is uniquely positioned, Ami, to impact fatigue compared to anything else because if you look at modafinil or stimulants, when they increase the dose, to a certain extent, it causes alertness and wakefulness. After that, patients start getting anxious, irritable, but it does not necessarily impact fatigue because fatigue is somehow uniquely related to the histaminergic mechanism of action. This histaminergic mechanism of action positions Pitolisant to treat fatigue. We have shown that in two different indications. Based on that, we have a high level of confidence that Pitolisant will be impactful in fatigue in patients with narcolepsy.
Yeah. Ami, fatigue has been an area of interest, given sort of the mechanistic fit, as Kumar alluded to, working through the histaminergic system and how fatigue is sort of mediated in terms of the CNS. If we look out sort of longer term with a Pitolisant HD product and with the long runway, we see the potential for additional opportunity beyond narcolepsy, beyond IH, beyond myotonic dystrophy. In chronic neurologic disorders where fatigue is a prominent symptom, such as multiple sclerosis, such as patients with Parkinson's disease, we could take the development of Pitolisant HD potentially to broader populations targeting fatigue as a prominent symptom in these patient populations with a chronic neurologic disorder. We are excited about exploring that component in the Pitolisant HD program for narcolepsy.
Okay. Thanks. I wanted to switch gears to EPX-100. Can you talk about the mechanistic rationale for that drug and maybe how transferable is the zebrafish model into the clinic?
Right. EPX-100, clemizole hydrochloride, it's an established serotonergic 5-HT2 mechanism of action. If you look at the pathophysiology in developmental epileptic encephalopathies, it's really because of the interneuronal serotonergic dystrophy that is seen. That's why serotonergic drugs, the drugs that increase the serotonergic tone in the central nervous system, are efficacious. We see this with fenfluramine. The other serotonergic mechanism of action drugs have also established proof of concept. We saw similar things in our zebrafish model as well. The translatability of what we see in the preclinical to the clinical model, if you look at the zebrafish model, is actually pretty high. In fact, there is 100% positive predictive value based on that particular model. In the clinical setting itself, we have a phase III study ongoing in Dravet syndrome. A lot of these patients have rolled into the open label extension study.
The data that we are seeing, we haven't disclosed this yet in public domain, is very promising and encouraging. We started the phase III registration study in Lennox-Gastaut syndrome as well. We are making good progress on both of these pivotal registration studies and anticipate top line in 2026. We also disclosed some emerging safety and tolerability data at the last investors' day meeting. What we saw is, again, very promising and very encouraging. From a tolerability perspective, we did not see any suppression of appetite, which is a big problem with the drugs that are approved to treat this condition, especially the two drugs that are used extensively, which are fenfluramine and Epidiolex. We did not see that. We did not see any significant incidence of diarrhea, abdominal cramping, or vomiting that is often seen with some of these drugs.
More importantly, the safety profile, we did not see any abnormalities in liver function tests that is often seen with Epidiolex. There is no need to do regular echocardiogram that is a requirement for fenfluramine, including the REMS program. We are looking at a very differentiated target product profile with efficacy similar or better than the established serotonergic mechanism of action drugs and a safety and tolerability profile that is much, much better compared to what we have in the market or in the development currently for patients with Dravet and Lennox-Gastaut syndrome.
Thank you. I want to talk a little bit, kind of just, I want to kind of take a step back and talk about kind of just your broader strategy around building out this pipeline. You certainly have a very strong balance sheet with the performance of Wakix over the years. You have executed on several business development opportunities to build out that pipeline. Maybe if you could sort of talk to how you went about picking the right assets, right? It is getting more shots on goal, but also picking the shots on goal that make sense, right, in a financially prudent manner. How did you sort of think about that? Also, going forward, how are you thinking about leveraging your capital to continue to sort of build those shots on goal? Kind of a two-part question there, but if you could address that.
Yeah. Ami, let me start with this strategic framework, and then I'll turn it over to Sandip to sort of talk about how deployment of capital or thinking there. In terms of when we went about building out kind of our pipeline, and when I stepped into the CEO role, I think I've shared this before, the mandate from our Board was with the strong commercial business with Wakix, go sort of build the pipeline. We approached it very strategically and very thoughtfully with regards to looking at staying within kind of orphan rare neurological kind of neuropsych neurobehavioral conditions based on the BD opportunities that we saw out there. We really leveraged the internal kind of expertise with regards to you talk about how did we pick the assets and the shots on goal and our confidence in what we were bringing in.
A lot of it, Kumar and his team and our experienced regulatory team in terms of regulatory pathways to success, I think that it was really data-driven. The data that we saw from the phase II-III CONNECT study for ZYN002 giving us confidence of pulling it through in the phase III pivotal trial. Kumar just talked about in terms of EPX-100 and what we saw in some of the preclinical models that are very transferable to the clinic. A data-driven approach with regards to assets with a strategic fit that we could kind of bring in and build out the pipeline that has now resulted in three orphan rare CNS franchises with significant market opportunity. We also looked at deal terms that were sort of smart.
The way we went about that with regards to being able to really bring in these assets to drive value with sort of minimal investment upfront and then de-risk with kind of milestones on the back end. We continue to take a similar approach with regards to either going deeper in any of the three franchises that we're in, sleep, wake, neurobehavioral, or in the epilepsy space. If we see something that's really compelling in an adjacent orphan rare CNS condition, we would also contemplate that for the right deal terms. In terms of as we look ahead, I think Sandip can kind of share some of our thinking about deploying capital in terms of in a kind of thoughtful strategic way. Sandip?
Yeah, sure, Jeff. I mean, look, as was mentioned earlier, I mean, we have a very unique business model in the biotech space, right? We have a growing top line. We're profitable, positive cash flow generating. Just in last year, I think we generated over $200 million in cash, closing the year at about $576 million of cash. I think this is a real important distinction, especially in the current market environment where investors are looking at companies with strong fundamentals. I think that's been our model right from the start, achieving profitability, leveraging good margin expansion, and using that capital to actually do three. We've done three transactions in the last two years. As Jeff mentioned, relatively low upfront, success-driven milestones, focusing the capital on advancing these programs in the clinic as we're doing with the Fragile X program, which hopefully will have top line later this year.
Again, we're going to continue with our recipe, continue to keep strong fundamentals in the company, and deploy capital where it can really help drive value for shareholders through additional opportunities. What I'd say is we obviously continue to have a dedicated business development team. They're very active in this space. I think the current equity environment actually makes it even more attractive for our team. We continue to be focused out there and really looking for opportunities to drive value for shareholders.
Thank you, Sandip. I'm being told that we're almost out of time, but I would be remiss if I didn't ask you about the tariff question, which I think everybody's interested in. With what's gone on in the last couple of days, there's a very real possibility that there will be tariffs levied on imports relating to the pharmaceutical industry as well. I think investors are curious to just understand, as you think about your supply chain, sort of where are kind of the pieces of supply chain based? Anything kind of related to that that you can comment on?
Yeah. Yeah. Go ahead, Sandip.
Yeah. No, I think with respect to tariffs, I mean, like everyone else, we're following the situation closely. We have a dedicated team in government affairs as well that actually follows what's happening legislatively as well and following the landscape. I think at this point, as you know, there's not been any tariffs announced on pharmaceutical products, but that's really currently hard to say, predict the future on that. However, what I would say is from a Wakix supply chain perspective, most of our supply is from France. We bring in materials made there, and we import it into the U.S. We also have been looking over the last couple of years and looking at local providers as well to qualify secondary suppliers as well. That's been a project that we initiated several years ago that we're currently in the process of going there.
Again, we follow the space. We'll continue to monitor the situation as well. We are, I think, in a strong fundamental financial position as a company, as we discussed, and we'll react accordingly.
Maybe just quickly, where is the IP based for Wakix?
The IP is based here in the U.S. We're a U.S. company. We're primarily focused in the U.S. We don't have any, we don't have our IP offshore like many other companies. We're a U.S. company registered here and housing the IP here as well.
Okay. All right. Looks like we are a little bit out of time here. I would like to close our conversation and thank all of you for taking the time to do this chat with me. Thanks to all our listeners as well for joining.
Yeah. Ami, thanks again for the opportunity. Always enjoyable to speak with you. It was a great opportunity to provide an update on the Harmony business going forward and excitement we have in our pipeline programs. Thank you.
Yes, indeed. We have a lot of things to look forward to on the Harmony story. We will stay tuned. Thank you.
All right. Bye now.
Thank you.
Thank you, Ami.
Bye-bye.