Harmony Biosciences at Leerink Conference: Expanding Horizons in Rare Disorders

On Wednesday, 12 March 2025, Harmony Biosciences (NASDAQ: HRMY) presented at Leerink’s Global Healthcare Conference 2025, outlining its strategic shift from a single-product company to a diversified biopharmaceutical entity. The company is focusing on expanding its pipeline in rare neurological disorders while leveraging its existing commercial infrastructure. Despite some challenges, the company remains optimistic about its growth prospects.

Key Takeaways

• Harmony Biosciences is transitioning from reliance on Wakix to a broader pipeline strategy.
• The company aims to launch new products or indications annually, with up to six programs entering Phase III trials by year-end.
• Financially strong, Harmony expects sales between $820 million and $860 million this year, with a goal of reaching $1 billion.
• The RECONNECT Phase III trial for ZYN002 in Fragile X Syndrome is progressing, with data expected in Q3.
• The company is actively exploring business development opportunities to expand its pipeline.

Financial Results

• 2023 sales were approximately $715 million.
• 2024 sales guidance is set between $820 million and $860 million.
• Harmony aims for a $1 billion opportunity with Wakix in narcolepsy.
• The company ended the last quarter with over $576 million in cash reserves.

Operational Updates

• Harmony has eight assets in the clinic across 13 development programs.
• Up to six programs may enter Phase III trials by the end of the year.
• The RECONNECT Phase III trial for ZYN002 is on track for data readout in Q3.
• EPX100 trials for Dravet syndrome and LGS are ongoing, with data expected in 2026.
• New formulations of Wakix, including pitolisant GR and HD, are in development with PDUFA targets in 2026 and 2028, respectively.

Future Outlook

• Harmony seeks to expand beyond Wakix, focusing on rare neurological disorders.
• The company plans to leverage its commercial infrastructure and explore additional indications for existing assets.
• Business development efforts are underway to identify new pipeline opportunities.

Q&A Highlights

• The RECONNECT trial aims to replicate positive results in Fragile X Syndrome, with potential for a broader label.
• The novel Orexin II agonist program shows promise for a best-in-class profile.
• EPX100 addresses unmet needs in Dravet syndrome and LGS with a simple dosing regimen.
• Wakix’s growth is driven by its broad clinical utility and non-controlled substance status.

For a detailed understanding, readers are encouraged to refer to the full transcript provided below.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Madhu Yannawar, Equity Research Team, Leerink: Hi, everyone. Thanks for joining us today. I’m Madhu Yannawar. I’m on the equity research team at Leerink and really happy to welcome Harmony to be with us today. We have Jeff Dano, CEO, Kumar Budur, CMO, and Sandeep Kapadia, CFO, on the stage with us today.

So, would you like to begin by making some opening statements?

Jeff Dano, CEO, Harmony Biosciences: Yeah, sure. Yeah. Thank you for the invitation. Yeah. Good afternoon, everyone.

So I think Harmony Biosciences, we are very excited about, I think, the growth of the fundamental business in terms of Wakeix and narcolepsy and now year six in the market and on our way to $1,000,000,000 plus opportunity. But more importantly, I think we’re excited about the robust late stage catalyst rich pipeline that we built over the past one point five years, two years. So with that and the acquisitions of Zynerva Therapeutics, bringing in ZYN002 and our lead program in Fragile X Syndrome, which we’ll talk about, and Orexin II agonists, obviously a discussion next door about the potential of that class and then a rare epilepsy pipeline with the acquisition of Epigenics Therapeutics, really the most advanced five HT2 agonist program in the clinic that Kumar will share with you. So really that rolls up to in terms of the narrative has shifted from just the Wake X commercial business to the excitement of the pipeline and those catalysts. And we’ve got three orphan rare CNS franchises, each with potential peak sales opportunities of $1,000,000,000 to $2,000,000,000 each.

And we now have eight assets in the clinic across 13 development programs, and up to six in Phase III by the end of the year. So we feel we have one of the most robust and deep pipelines in the industry for patients living with rare neurological disorders. And we’re on track potentially if we’re successful to deliver one or more new product or indication launches each year over the next several years. So we’re very excited about that opportunity and really potential for helping thousands of additional patients living with rare diseases and value creation for our investors.

Madhu Yannawar, Equity Research Team, Leerink: Great. So maybe let’s start with ZYN002 since you brought that up. I believe that’s your next big catalyst that we’re all looking forward to. So can you just remind us what’s been shown already from the CONNECT study and what you are hoping to see in the upcoming results?

Jeff Dano, CEO, Harmony Biosciences: Yes. We’re actually very excited about that. And I think as our pipeline comes more focus, so our next major clinical milestone ZYN002, a very interesting innovative product. I don’t want to steal Kumar’s thunder, but a purely synthetic pharmaceutically manufactured cannabidiol gel through transdermal delivery, devoid of THC, which has certain advantages that Kumar can describe, with regards cannabidiol and that mechanism in patients with Fragile X. I think importantly, and then Kumar will expand, the Phase III RECONNECT trial is really designed to replicate the key findings from a pre specified analysis of the Phase twothree CONNECT study, which demonstrated in patients with full complete methylation a statistically significant and clinically relevant outcome on the primary endpoint in the social avoidance scale, subscale of the ABC checklist.

With that, Kumar, can you kind of give an update of where we are and why we have strong conviction in the Phase III trial and on track, you know, for the data readout in third quarter?

Kumar Budur, CMO, Harmony Biosciences: Thanks, Geoff. Thanks for the question, Madhu. So FasoLex Syndrome, here we really have an opportunity to bring the first and the only approved treatment in patients with Fasler X syndrome. First, a quick word about the disease state itself, very well known Fasler X syndrome, approximately eighty thousand patients in The U. S.

Alone, And for ZYN002, it’s a global opportunity for us caused by mutation in FMR gene, which dysregulates the endocannabinoid system, and ZYN002, by interacting with CB1 receptors, restores the homeostasis of the endocannabinoid system. The product itself, it’s a patent protected, permeation enhanced gel that has significant advantages because cannabidiol, if it’s given orally, can cause significant nausea, vomiting, and diarrhea, and also because of the first pass metabolism, could cause some liver function test abnormalities. And we do not see that with Z1-two. In fact, one of the features that we are really happy about Z1-two is the long term safety and tolerability data. Some of the patients who use Z1-two for Fasolet Syndrome are now continuing to take the drug eight years out.

And thus far, the only clinically meaningful or relevant treatment emergency adverse event that is seen is application site reaction in about seven percent of the patients. Finally, in terms of efficacy, as Jeff was mentioning, what we are trying to do in RECONNECT study is essentially trying to replicate the positive data that we saw in patients with complete methylation. So the target population is the same, patients with complete methylation. The primary endpoint is the same, and we are increasing the probability of success by making some enhancements, like increasing the duration of the study to sixteen weeks because we saw patients continue to get better from twelve weeks to sixteen weeks, and increase the dose in patients who weigh greater than fifty kilograms. Overall, a very well designed study based on the positive data from the CONNECT study, essentially trying to replicate the positive findings from CONNECT study.

Madhu Yannawar, Equity Research Team, Leerink: Great. And could you remind us if there’s any connection between the complete methylation and the mechanism of this?

Kumar Budur, CMO, Harmony Biosciences: Yeah. Great question, Madhu. Yes. What happens is in full mutation, it’s basically a triplet nucleotide repeat disorder. If the CGT triplets exceed more than 200, then there is complete methylation of the gene.

What it does is it essentially silences the gene, which means that there is hardly any production of FMR protein, and that results in the increased severity of symptoms. So full mutation, complete methylation, larger symptom burden, and the more likely for Z1 and two to show efficacy. What we saw from the CONNECT study is about eighty percent of the patient had complete methylation. And in those patients, we not only saw statistically significant improvement, but also clinically meaningful difference. So it doesn’t mean that Z1002 doesn’t work in patients with partial methylation.

It still does, but the response is a bit unpredictable, creating some heterogeneity in the signal detection. So that’s why, you know, RECONNECT study, the target population is complete methylation.

Madhu Yannawar, Equity Research Team, Leerink: Does this have any label implications or do you think it would be used in the broader population? Yeah.

Kumar Budur, CMO, Harmony Biosciences: Actually, it just reminded me about one thing that I forgot to mention, which is during the discussions with the FDA, at the request of the FDA, we are enrolling nominal number of partial methylation patients as well. So if the primary endpoint is positive and if the data in partial methylation patients is supportive or is it trending in the same direction, there is a possibility of a much broader label.

Sandeep Kapadia, CFO, Harmony Biosciences: Yes. And I think also just if we’re obviously successful with, in fragile X, we also have a follow on indication of 22 Q that the team is also working on as well. So really an opportunity to really expand it beyond Fragile X.

Jeff Dano, CEO, Harmony Biosciences: Yes. So really excited about this program. I think sort of all those factors with regards to no approved treatments for Fragile X. And I think looking at the data and some of the skepticism, I think that the Phase II, Phase II, III CONNECT study was kind of a negative study on the primary outcome. We acknowledge that.

But if you look at the eighty percent of that cohort that had complete methylation, it was a strong, statistically significant, clinically meaningful signal that the Phase three RECONNECT trial is designed to replicate. So with that sizable market opportunity, as Kumar mentioned, about eighty thousand patients in The U. S, plus we have global rights to ZYN002. We could partner that out in other territories. So I think and with positive data, Kumar and the team are ready.

We have another follow on indication in 22q deletion syndrome lined up right behind that with interactions with the FDA about a pivotal Phase three design. So lots of opportunity there in an area of high unmet medical need that we’re excited about.

Madhu Yannawar, Equity Research Team, Leerink: Got it. Great. And last question on this product was, just in terms of physician feedback on the data that you’ve shown so far, like how meaningful are these endpoints to physicians and caregivers? Just curious on that.

Kumar Budur, CMO, Harmony Biosciences: Yeah. I mean, from a clinically meaningful perspective, a change in three points in social avoidance subscale is considered clinically meaningful and that’s what we saw in the CONNECT study. From a clinician perspective, they’re very excited, especially in the context that there are no approved treatments for this particular indication. So if Z1 two were to be successful as I made that statement initially, it will be the first and only approved treatment for any symptoms in patients with Faso

Jeff Dano, CEO, Harmony Biosciences: Yeah. I think the other is the anecdote you often share in terms of, I guess patients on ZYN002, you know, going on eight years now. And when they started, you know, they were young children and now some of them are still on, you know, the product seven, eight years.

Kumar Budur, CMO, Harmony Biosciences: Yeah. I mean, the very first study in Faso Alex syndrome was started with Z1002. Some of these kids were in middle school and now they are in college continuing to use Z1 two eight years out. It’s just the persistence of efficacy in a neuropsychiatric indication is pretty unprecedented. You don’t see this level of persistence of efficacy and maintenance of treatment in neuropsychiatric conditions.

Madhu Yannawar, Equity Research Team, Leerink: Great. All right. So maybe moving on to your Orexin program. I’m sure you’re really excited to talk about that. Could you tell us how this may be differentiated from other products that are in the class right now?

Jeff Dano, CEO, Harmony Biosciences: Sure. Kumar, do you want to

Kumar Budur, CMO, Harmony Biosciences: Sure. I mean, yeah, several things, Madhu. I mean, to start with, look, OraxSense clearly the next phase of innovation. We’re excited about Orax interceptor agonists for patients with narcolepsy. Coming to our specific Rx interceptor agonist, first of all, it’s a novel chemical structure.

It’s not a me too, pyrrolidone, sulfonamide, bicyclic moiety. We decided to leverage the learnings from the other orexone receptor agonists, came up with this novel structure, and that clearly has some implications. In terms of potency, this continues to be the most potent orexone receptor agonist based on all the publicly available data, excellent selectivity, potential for one-sided osync, and relatively clean preclinical safety profile. So the combination of all of these factors could potentially make this asset a potential best in class or acceptance of the antagonist. Obviously, that has to pan out in the clinical data, and we are on track for IAPD submission in the middle of this year, first in human studies in the second half of this year.

Madhu Yannawar, Equity Research Team, Leerink: Great. And, so can we expect to see any additional preclinical data this year at all?

Kumar Budur, CMO, Harmony Biosciences: Yes. We plan to present a comprehensive preclinical safety and efficacy data at the annual sleep meeting that’s in June in Seattle this year.

Madhu Yannawar, Equity Research Team, Leerink: So maybe moving to the EPX100 program, that’s the rare epilepsy drug that you have. Maybe just some of your initial thoughts on that product and how that could be differentiated as well.

Jeff Dano, CEO, Harmony Biosciences: Yes, sure. So in terms of the rare epilepsy sort of pipeline that we brought in with the acquisition of Epigenix Therapeutics, I guess, last April, so we were busy on the BD front over the past year and a half, two years. So really, EPX100, clamsol hydrochloride, a first generation antihistamine that was in the market for about twenty years, I think, with a good safety tolerability profile and a mechanism of action, you know, kind of proven in the zebrafish model for the rare developmental epileptic encephalopathies. And also, EPX200, a liquid formulation of larcasarin, that is in the early sort of development stage. And Kumar can give an update on really the important thing is the most advanced of the five HT2 agonist compounds in the clinic with EPX100 in Phase III for Dravet syndrome and we initiated a pivotal Phase III trial for LGS the end of last year.

Those are advancing and excited on track for top line data in ’twenty six.

Kumar Budur, CMO, Harmony Biosciences: Right. I mean, established serotonergic mechanism of action, reason to believe. There is a history of safety and tolerability data. Clemensol hydrochloride was in the market for almost two decades in 1950s and 60s, and it was sunsetted with the introduction of second generation antihistamines, no safety signal, And we pursued this as a new chemical entity, did a complete battery of non clinical tox studies, again no safety signal. We are in Tuva Center for Phase three, actively recruiting in U.

S. And outside of U. S. We initiated the study in LGS in the last quarter of twenty twenty four, so we are actively recruiting for LGS as well. A simple dosing regimen, a BID dosing regimen, which is clinically meaningful for this particular patient population.

And at our last, the only investor meeting, October, we shared the emerging safety and tolerability profile from the ongoing Phase III 2B syndrome. The tolerability was good and there was no need for any special monitoring like liver function tags or cardiac monitoring. So the overall benefit risk profile is pretty promising for patients with developmental epileptic encephalopathies leading with Dravet syndrome and LGS. And as Jeff was mentioning, we are on track for top line in 2026 for both indications.

Jeff Dano, CEO, Harmony Biosciences: Yes. And we see where we are kind of as a starting point, you know, with regards to the Phase III interphase and LGS. But we also have the opportunity to go broader in terms of broader type of basket trial approach in the DEEs as well as the opportunity. We have a lot of expertise in the epilepsy field, where we could build off of these assets and build out a broader pipeline in epilepsy.

Madhu Yannawar, Equity Research Team, Leerink: Got it. And then, could you just give us your thoughts on what the unmet need is for Dravet and LGS? There’s several other agents that are approved right now for those indications. So, what are you hoping to fill in terms of efficacy or safety kind of need?

Kumar Budur, CMO, Harmony Biosciences: Yeah. I mean, if you look, both of these indications, despite several medications approved, the patients continue to suffer from intractable seizures. When we did our market research and market analytics, it was not really surprising, but what was really that caught our attention is there about seventy eight thousand patients with Duverest Syndrome in The US. Almost six thousand of them continue to suffer from seizures. Very similar in LGS as well.

So clearly there is need for medications with better efficacy and also better safety and tolerability. And with cleanser hydrochloride, that’s exactly what we are trying to achieve. Good efficacy, non serotonergic mechanism of action, but more importantly, good safety and tolerability as well so that these patients can continue to take these medicines long term.

Madhu Yannawar, Equity Research Team, Leerink: Great. Shall we go to Wakeix?

Jeff Dano, CEO, Harmony Biosciences: Sure.

Madhu Yannawar, Equity Research Team, Leerink: Was there anything else that you wanted to mention regarding the pipeline?

Jeff Dano, CEO, Harmony Biosciences: No, I think we hit the highlights. I think we hit the highlights of the three orphan rare sort of neurologic disorders, the next major clinical milestone in the Phase three trial Fragile X. I guess I would say that with regards to if we’re successful in those new indications, we have a commercial model coming to Wake. So a proven commercial model with a single patient hub, closed pharmacy distribution system. So we have the ability to sort of utilize that infrastructure.

And these are not sort of large sales forces. A lot of this is a centers of excellence model. So we could potentially go to market with these new indications in a very cost effective manner, utilizing our commercial model, the infrastructure and then be able to sort of optimize those commercial opportunities. And again, both ZYN002 and EPX100, we also have global rights, not just in The U. S.

And we also have Phase III trials that have been discussed with EMA as well. So we could file both in The U. S. As well as in Europe.

Kumar Budur, CMO, Harmony Biosciences: I mean, just to add on, sorry, Tien. Both CYN-twenty ATX100, the clinical trial designs meet the requirement of FDA, EMA and other parts of the world as well. And that goes along with the fact that we have global rights for both of these, all of these assets.

Madhu Yannawar, Equity Research Team, Leerink: Looking forward to that data. Okay. So for Wakeix, you have a couple of next generation products in the pipeline. Maybe you could start by talking with your, about your plans for those.

Jeff Dano, CEO, Harmony Biosciences: Yes. So I think at a high level, we’ve got obviously Wakeix and Pitulcet, a first in class molecule, novel mechanism of action, very innovative, was the first new MOA in the narcolepsy market in over a decade, working through histamine, which has importance in terms of other some unique systems and symptoms working through histamine circuits. And so now a successful product in the market and the opportunity to enhance and improve upon that product. And I think the next generation formulations we’re working on represent kind of patient focused drug development. What are the ongoing unmet medical needs with regards to predisposition to GI symptoms in nausea and vomiting in about eighty percent to ninety percent of patients with narcolepsy, as well as the main sort of unmet need of residual symptoms and the need for enhanced efficacy with regards to what the Pitulosin HD or high dose program is designed to deliver.

So briefly, we’ve got two programs. Petyllacent GR, the gastrointestinal formulation is meant to it’s a quick to market strategy with a target PDUFA in 2026, which we’re on track for and designed to expand the base of patients on both Wakeix and the Petyllusin GR product. And then really the more novel unique formulation in Petyllusin HD, which with a target PDUFA in 2028, designed to really extend the pitalacin franchise not just beyond 02/1930, but into the mid-2040s with provisional patents filed to 02/1944. So I think with that, Kumar can give an update on where we are in those programs.

Kumar Budur, CMO, Harmony Biosciences: Yes. I mean, pituloscent GR, abbreviated clinical development path showing bioequivalence to break eggs to address the GI symptoms that are widely prevalent in patients with narcolepsy. About eighty percent of the patients have some kind of upper GI symptoms that’s because of the orexin dysfunction leading to vagus nerve instability causing upper GI symptoms. So the Pitulosin GR formulation is designed to address some of those symptoms. And the other distinguishing feature will be the ability to start at the therapeutic dose.

If you look at any other narcolepsy medications, they involve some kind of titration. And with Pituloscent GR, we aim to give the patients an ability to start at the therapeutic dose. Clinical development itself, we are initiating pivotal bioequivalence study this quarter. Top line data will be available in third quarter and we are on track for PDUFA in 2026. Pituloscent HD formation, Jeff mentioned the distinguishing features, very excited about pituloscent HD because in narcolepsy with the pitolloscent HD optimized formulation, and we discussed this data last year, we are showing an increase in relative bioavailability, decrease in inter individual variability, which has significant clinical implications, and also go up to two times the dose, the maximum level dose of Wake X.

So all of these features we anticipate or we hope to show increased efficacy with excessive daytime sleepiness, efficacy in cataplexy and also target fatigue in narcolepsy for which there are no two treatments. And the histaminergic mechanism of action of pyrtolycent uniquely suits to treat fatigue because of the nature of the symptoms. And we showed this already in a couple of our studies, one in myotonic dystrophy and some of the studies our partnered bio presented in sleep apnea. So that study is on target to start on the in the fourth quarter with PDUFA in 2028. And similarly, idiopathic hypersomnia, we are on track to start Phase three in the fourth quarter with PDUFA in 2028.

And, with idiopathic hypersomnia, apart from sleepiness and idiopathic hypersomnia symptoms, we’ll also be targeting sleep inertia as well.

Jeff Dano, CEO, Harmony Biosciences: Yeah. So I think the opportunity, you know, through the, sort of the mechanism of action working through histamine, the ability in addition to sort of the usual symptoms where fatigue is another important symptom in about sixty percent to seventy percent of patients with narcolepsy. We had strong data in a Phase II proof of concept study in patients with myotonic dystrophy. But it’s really a separate construct than EDS. There were some discussions earlier with orexin agonists and whether that mechanism would actually affect fatigue or not.

But clearly, different construct, you know, working kind of through histamine circuits. And we feel that with pitulosin HD that could help further differentiate the label, and really help, you know, patients also with fatigue as part of the symptom complex.

Madhu Yannawar, Equity Research Team, Leerink: So for idiopathic hypersomnia, I understand that the actual trial won’t start until later this year, but curious if you’re thinking about trial design and, what you might do differently from the INTUNE study, what might, what you might keep the same?

Kumar Budur, CMO, Harmony Biosciences: Right. I mean, with the, the study design for idiopathic hypersomnia, we have disclosed this. It will be a prospective parallel randomized double blind placebo controlled study, different from the randomized withdrawal study that we used in the INTUNE study. With the randomized withdrawal study design, there’s some challenges with the data interpretation and other things. The trial design that we will be employing going forward is something that we have discussed with the FDA.

The trial design and the endpoints is something that we are already aligned with the FDA.

Madhu Yannawar, Equity Research Team, Leerink: Great. Maybe moving to the base business of Wakeix. Maybe you could describe some of the commercial trends and market dynamics around the continued growth of this product?

Jeff Dano, CEO, Harmony Biosciences: Sure. Yes, let me start it and Sandeep can sort of also weigh in. So I think that in year six on the market, in an orphan rare disorder, we continue to see growth. I think we continue to see growth of Wakeix in narcolepsy really reflective of the broad clinical utility given the overall benefit risk proposition, and namely, the first and only approved product for narcolepsy that’s not scheduled as a controlled substance. With that reflects kind of the prescriber base.

So we call on 9,000 HCPs, which is the full market opportunity, and only 4,000 of them participate in an OxoBate REMS. So we continue to grow the business in the depth of prescribing in those HEPs. They have bigger, larger clinics and more patients, but also the 5,000 HEPs that don’t participate in OxoBATE RIMs. And we’re growing across the breadth of prescribing there. About 60% penetrated in that segment and continuing to grow.

So I think all this reflective of the product profile, continued growth, and I think we’ve guided this year to $820,000,000 to $860,000,000 on our way to $1,000,000,000 plus opportunity in narcolepsy alone in year six on the market. And I think that the patterns have been pretty similar kind of year over year. There’s some seasonal dynamics, but steady growth in terms of patient adds and how the product has performed, a lot of patient support in our patient hub in that unique commercial model. Sandeep, anything to add?

Sandeep Kapadia, CFO, Harmony Biosciences: No, I think you covered most of it. I mean, we have obviously great momentum from last year. We did almost $715,000,000 in sales, great going into this year with our guidance of $820,000,000 to $8.60 We’d be we closed the year about fourth quarter about 7,100 patients on therapy. And we need to get to the billion, we would need to get to about 9,000. So we’re not that far away from achieving blockbuster potential for the product.

So we’re very excited about the year ahead. Good continued growth quarter over quarter in terms of net patient adds is what we expect.

Jeff Dano, CEO, Harmony Biosciences: Yes. And I think going forward, even if the market doesn’t grow, which is narcolepsy as a rare disease, about eighty thousand diagnosed patients. So even if the market doesn’t grow, there’s plenty of opportunity there. It’s a polypharmacy market. I think it’ll continue to be a polypharmacy market.

The evolving orexin two agonist programs are we’re learning from them. It is the next novel target, in chronic neurological disorders, you know, with a lot, you know, symptoms that are difficult to treat. It’s rare that monotherapy wins the day. Oftentimes you need multiple agents. And I think that’s our position where we are.

And the other longer term opportunity potentially is our partner BioPerge generated some preclinical data showing synergistic mechanisms between orexin and histamine. They’re both in the hypothalamus near one another and the circuitry is very similar. So, you know, as we work on an orexin two agonist program and we have pitulosin HD going forward, you know, the potential opportunity, to consider combination, you know, drug development with two complementary synergistic mechanisms, you know, in the future. So we are we’re in sleep wake, you know, to stay for the long term. We’re well established both with the treating medical community, with the clinical investigative sites because we’re gonna have multiple programs in the clinic and we’re excited about those opportunities.

Madhu Yannawar, Equity Research Team, Leerink: Seconds or so, any additional plans for BD or anything that you think is really interesting out there that you’re looking at?

Jeff Dano, CEO, Harmony Biosciences: Yes, yes and yes, I would say. I think strong balance sheet. We feel like we’re just getting started in terms of building the pipeline, expanding the pipeline. Given the current market, there are interesting opportunities out there either going deeper in one of our three franchises or possibly an adjacent orphan rare neuro opportunity. And we have the ability to transact.

We have a dedicated business development team that kind of looks across the market. So yes, we plan to continue to build out and grow the pipeline, and I think we have the capacity and the expertise to do so.

Sandeep Kapadia, CFO, Harmony Biosciences: Yes. Just to add, obviously, we’re also a very profitable, positive cash flow generating company, very differentiated in that way. So it really gives us the flexibility. Everything that you heard today in terms of programs were well funded, you know, just from our existing balance sheet and with close over $576,000,000 as at the end of last quarter really positioned us as well to execute on not only the late stage program that we have, but also with respect to the

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