Harmony Biosciences Holdings, Inc.

Performance in the court reflects the strong underlying demand for WCAG, partially offset by the seasonal market access headwinds the industry sees at the start of every year. Cost of goods or products sold was 20.7% of net sales in comparison with 17.3% one year ago. This year-over-year increase in cost of products sold as a percentage of net revenue was almost entirely driven by new royalties related to the Novidium License Agreement. providing new development opportunities in broader CNS indications. We reported total operating expenses for the first quarter of $133.6 million compared to $96.5 million in the same quarter in 2025. The growth in expenses reflects continued investment in R&D and ongoing investments in the commercialization of weight fixing and narcolepsy. These operating expenses also include the costs associated with upfront licensing fees of $32 million or $0.45 per share on a fully taxed basis related to the amorphous license agreements. Without these costs, operating expenses were up around 5%. Gap net income for the first quarter of 2026 was $32.5 million or $0.55 per share. This compares with $45.6 million, or $0.78 per share. Of course, that includes $0.45 in costs related to the in-license of the amorphous form of Pitocin and new development opportunities. We ended the first quarter with $870.5 million in cash and cash equivalents. Cash flow generation in the quarter was muted by the licensing fees and a large reduction in accrued expenses and a modest reduction of debt. We ended the quarter with $160 million in debt, cash flow generation will reaccelerate in the coming quarters. That said, it's our intent to deploy cash into business development with the objectives of enhancing revenues in the 2028 to 2032 timeframe, consistent with our four key pillars of value creation for shareholders. And with that, I'd like to turn the call over to Jeff for his closing remarks. Jeff?

Thank you, Glenn. And again, welcome to the team. In closing, I have shared with you our four pillars of value creation that we feel matter most to investors and will serve as the framework by which our performance will be measured. First, protect the Pitocin franchise into the 2030s. Second, continued growth of the Pitocin franchise in an evolving market. Third, drive value from our robust pipeline centered around BP205, our potential best-in-class orexin-2 agonist. And last, a renewed emphasis on business development with our goal to transact. We believe when we execute on these four strategic pillars, we will be well-positioned to bring innovative treatments to patients with unmet medical needs while driving sustained long-term value for our shareholders. Thank you for your attention. I will now turn the call back over to the operator for Q&A. Operator?

Thank you. At this time, I would like to remind everyone, in order to ask a question, press star then the number one on your telephone keypad. Again, that will be star one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. We have the first question comes on the line of David Anselm of Piper Sanders. Your line is now open. You may ask your question.

Hey, thanks. So I have a few questions on BP 205. Just give us a roadmap on how to think about data milestones as we move through 2027. um particularly um in healthy sleep deprived volunteers and then secondly why not just move right into uh actual narcolepsy one and narcolepsy two and ih patients in a phase one b just given that it's it's become a pretty crowded landscape just as a way to expedite development i wanted to get your thought process there and then lastly With other indications, mood, ADHD, cognition, fatigue, as you alluded to, can you talk about early stage work that you're going to be doing over the next 12 to 18 months that could help you decide what paths to take in terms of the non-sleep break indications? Thanks.

Good morning, David. Thank you for your question. With regards to BP205, first let me frame overall, you know, our excitement around, you know, the potential opportunity we have, you know, with our orexin-2 agonist. And it's really based on, you know, as you've heard us say, the novel chemical scaffold and really, you know, the highest potency of any orexin-2 agonist in the clinic. With that, it gives sort of the differentiated features with a product profile likely to be best in class. With regards to timing of the development program and other indications, first, the issue with indications outside sleep-wake and central disorders of hypersomnolence, the opportunity there is that those are not based on a state of erectile deficiency. In those conditions, potency matters where we think we would have a significant opportunity, not just with BP-205, but other compounds that we're working on with our partner, BioPregé. So now I'll ask Kumar to sort of provide, you know, what the timeline looks like on the current development program. Kumar?

Thank you, Jeff. Good morning, David. You asked several questions, so let me try and answer one by one. In terms of data milestones, we are on track to receive single ascending dose clinical PK data in the middle of this year. We also continue to dose patients in multiple ascending dose study, the food effect study, things like that that are important before we go to the later clinical stage of development. In terms of your question, why not go straight into clinical proof of concept rather than sleep-deprived healthy volunteer study? Great question, David. One thing to remember is PP205 is the most potent orexin receptor agonist in clinical development. So it's good to get a nice bracket around the dose range before we go into clinical proof-of-concept studies. And also another thing to remember is this is not going to add to the timeline. This is done in parallel with the multiple ascending dose study, and the data we need that before we go into clinical proof-of-concept studies. You also talked about the other indications, since we are very excited about the profile of BP205. Most potent Oryxin receptor agonist, and Jeff alluded to some extent in his response, it's very important that potency translates into efficacy, and we saw that in our preclinical animal models and in other indications. it becomes all the more important because we'll be depending on some of the downstream effects of the RxR receptor agonist in conditions like mood, fatigue, cognition, ADHD. We are conducting several preclinical experiments right now, and as the data becomes available, we'll be able to disclose. Hope that answers all of your questions. Thanks, David.

And David, final comment on that. I think as I've discussed with the team, given the potential value of this class of compounds, it's our intent to invest in this program with regards to where we are now, additional compounds, and look at the broad opportunity with not just BP205, but other compounds that we're working on. Thanks, David.

Thank you. Again, if anyone would like to ask a question, please press star 1 on your telephone keypad, and we kindly ask each participant to limit their question to one question and one follow-up. Next question comes from the line of Ami Fadia from NIDAM. Your line is now open.

Good morning. Thanks for taking my question. Maybe one main question and a follow-up. You gave some sense about the litigation versus AAT Sanders, and then there seem to be two trials here. Can you talk about kind of what we can expect in terms of next steps with regards to how the litigation might proceed over the course of the next couple of months. And then a follow-up on the orexin question from earlier. With the sort of higher potency that you've highlighted, how do you see it being differentiated in the sleep-wake area relative to the other orexins that are in development? And then can you elaborate a little bit more on the other indications? Do you see that, you know, other indications such as ADHD, mood, fatigue, etc., being ones where you would study it as a combination treatment with other assets, or do you see it being developed both as a monotherapy and then also explore other combinations? Thank you.

Morning, Ami. Let me address your first question and then I'll have Kumar address the follow up on BP205. So I want to take a minute or two to provide clarity with regards to the IP situation and around the WCAGs and the Tulsa IP estate. Before I provide some detail, I first want to be clear about our position. We believe in the strength of our IP and we continue to vigorously protect it. And it's based on a multi-pronged strategy On with the tolls and IP estate, which is also multi-layered So with regard to some of the detail of the detail to provide clarity So recall we settled with six of the seven and the filers AET was the one remaining party who went to trial in in February That legal process continues. It's currently in post-trial briefs. And that part of the process will be completed towards the end of May. So during the trial in February, AET and Sandoz stated that, you know, the product will contain an amorphous form of a tolsen hydrochloride rather than a crystalline form, which is covered by our 197 polymorph patents. and they did that sort of in an effort to work around that IP. So we believe that AET and Sandoz infringed our 197 patent and during the trial, they also admitted to the facts that they infringed the 920 amorphous patent that we licensed from Novidium. Based on that, when we learned of that at the trial, that is when Harmony and Novidium recently filed the patent infringement lawsuit against AET Sandoz, alleging infringement of the 920 patent, covering an amorphous form of the Tolleson hydrochloride. So that suit is a new and separate action, different from the legal proceedings of the ANDA litigation that took place in February, which is ongoing. And that new suit is also being presided over by the same judge. That is a new legal proceeding which is just getting started. So based on this multi-pronged strategy, the different factors that I just mentioned, we remain confident in the strength of the IP estate, again, which is multi-layered with multiple components, enabling exclusivity into 2030, inclusive of six months of pediatric exclusivity. Kumar, over to you.

Thank you, Jeff. Good morning, Ami. So in terms of potency, you may have heard me talk about it many, many times in the past as well, why potency matters with RxN2 receptor agonists. It matters because it gives us the ability or the flexibility to use low doses to target all three central disorders of hyposomal lens, how it could potentially manifest itself in a clinical setting, Well, with low doses, we'll be able to avoid the off-target AEs. That's number one. The number two is having a high-potent drug. As we know, the doses required for NT2 and IH are relatively larger based on the data that we have. So it provides us an opportunity to use the same compound to treat all three central disorders of hypersomnolence, NT1, NT2, and IH, rather than use different compounds. or go to high doses, which may actually result in some AAs. In terms of the combination, that's a great question, Ami. There is a scientific rationale to potentially realize synergistic effect by combining pitolacent, which is a histaminergic drug, with an orexin agonist, because the neurocircuitry is such that orexin acts at a higher level, and the Neuronal connections between the anorexic neurons and histaminergic neurons in tubular mammary nucleus is very well established. So this is something that we are very interested in and we are looking into.

Thank you. We have the next question. It comes from the line of Greg from Missoula. Your line is now open. You may ask your question.

Okay, thank you for taking my questions. I've got two. My first, if we could just talk about the WCAG ramp right now. My apologies, I'm a bit late on the call. I know that you're reiterating the guidance for this year and that you added 100 in that patients. Should we expect the balance of the year to pretty much reflect what we've seen in the past in terms of second quarter, third quarter, and fourth quarter dynamics, or is there anything this year as the product matures that we need to be aware of? And then just secondly, going back to the ongoing litigations that are ongoing, I was curious if you could provide a sense of, in terms of the timing of when you decided to sue on the second lawsuit on the potential Novidium IP that you licensed in. I was curious as to why you chose to sue when you did versus perhaps waiting for the outcome of the original A&D litigation on a view that, at least based on our work, I think there's still a potential chance that you would win. So thanks for my questions.

Good morning, Greg. With regards to WCAG's performance, let me just sort of frame and then over to Adam for more commentary. So I think we're off to a strong start, you know, with good, strong demand that continues for the WCAG franchise. And as well as through the quarter, we saw good momentum, you know, coming out of the first quarter, exiting with about 8,600 average patients. So with that, we're on track to achieve full-year guidance of over a billion dollars, and I think Adam can provide more color on the continued growth of the Waco franchise.

Thanks, Jeff, and good morning, Greg. Thanks for the question. So in the first quarter, we achieved 215.4 million in net sales. That represents about 17% growth year over year, and that is exactly the growth level that we need to achieve in order to hit our full-year guidance of $1 billion to $1.04 billion for the full year. Greg, as you know, and we talked about this before, we typically see seasonal headwinds in the first quarter as we start the year related to market access and payer changes. And we saw that again this year, no surprise. So, plan changes, consumer switching plans, increases in premiums, you know, these are factors that can delay some patient starts as we start the new calendar year. And we saw that again this year. That said, underlying demand remains very strong. You know, we're just coming off three consecutive quarters of record growth, and we saw the same level of demand in terms of new prescriptions and new patient starts consistent with that recent performance. And actually, first quarter demand this year was even higher than it was a year ago. And in March, we saw the highest demand that we've seen in all but two months in 2025. So, the momentum is there. To answer your question directly, yes, we would expect the remainder of the year to play out similarly as we've seen really in the last six years in terms of WCAG's performance. And that this first quarter is just down to the typical, you know, start of the year market access headwinds. Thanks for the question.

And Greg, with regard to the second question on the timing of our lawsuit with Novidium with regard to the amorphous patent, I want to take the opportunity to welcome Peter Anastasiou to the Harmony team, our Chief Operating Officer who is working very closely with me on all the matters related to IP and ANDA litigation.

Peter? Yeah. Hello, everyone. It's a pleasure to be on the call with you. Look forward to meeting those of you I don't know in the very near future. To answer your question in terms of timing, first let me just say we agree with you that we believe we will prevail in the ANDA case. And so this filing of this lawsuit in no way reflects any other belief than that. It's an effort to make sure that we're asserting our full rights. So we believe that evidence was introduced that there is infringement on our polymorph patent, and we believe that our method of use patent is absolutely valid. Having said that, during that trial, AET and Sandoz also introduced very clear evidence that they are violating the amorphous patent, the 920 amorphous patent that we licensed from Novidium. So when you asked about timing, it was after those facts were entered into evidence in the trial that we, along with our partner Novidium, decided that we were going to fully assert our rights to defend the IP for Pitolisant. And as Jeff has said many times, this is a multi-layered approach. so that's why we filed suit in April and again these are two different cases with two different time courses and we believe that we will prevail in both cases and that's why we have strong confidence in our exclusivity going into 2030 inclusive of the six-month exclusivity thank you Peter thanks great

Thank you. Next question, we have the line of Pete Sabropoulos from Cantor Fitzgerald. Your line is now open. You may ask your question.

Good morning, Jeff and team. Congrats to Glenn and Peter on joining the team, and thank you for taking our questions. You know, can you touch on EPX100 for Dravet? The clinical data disclosed at AAN. Can you comment on baseline seizure rates and baseline anti-seizure med use? Sort of how do they compare to the real-world patients and patients enrolled in other Dravet clinical trials? And with interim OLE efficacy data and safety data in hand, what's your view on the emerging benefit-risk profile? How competitive do you believe the profile is, and where do you see it fitting into the current landscape? Thank you.

Good morning, Pete. Thanks for your question. Two more.

Yeah. Good morning, Pete. EPX100 clinical data that was presented at the recent AAN meeting, that's on-call data that we had already presented at the AAS meeting in December last year. Just to refresh, the data is from the open-label extension part of the ARGUS study, the Phase 3 Pivotal Registration Study in Drube Syndrome. What the data showed is that in patients who had at least six months of exposure to EPX100. We saw a median reduction of 50% in seizures as measured by CMS28. And we also saw 50% of patients experiencing 50% reduction in seizures. Both of these measures are considered clinically meaningful. Now the other side of the coin is safety and tolerability, which is extremely important in this patient population. Given many of these patients are on four to six anti-seizure medications and still have residual seizures. And that's exactly how EPX100 was used in this study as adjunctive therapy. And on average, patients were on about four different anti-seizure medications. It doesn't require any special monitoring, which is very important. No echocardiograms, for example. The lab values were really fine, so there is no need to monitor liver function tests as necessary. is often the case with some of the anti-seizure medications. And more importantly, the tolerability, because a lot of these medicines do cause nausea, vomiting, abdominal cramps, diarrhea in patients up to 20% to 30% in some instances. What we saw with EPX100, the only AE of note was actually diarrhea in about 2% of the patients. So the combination of clinically meaningful efficacy, favorable safety and tolerability profile, as an adjunctive therapy in a patient population known for refractory seizures position CPX100 very well from a clinician, from a prescribing algorithm perspective. I hope I answered all of your questions.

Thank you. Thank you. Next question comes from the line of Patrick Treacher from HC Wainwright. Your line is now open. You may ask your question.

Thanks. Good morning. I was hoping to get a little bit more detail on the DD strategy, just in terms of the size and the disease areas that you would be most interested in, particularly as we think about TNS adjacencies beyond rare disease. And then separately, as we approach the BP205 data in the middle of this year, I'm wondering if you can tell us what specific PK parameters and tolerability bar would validate, you know, the best-in-class claim.

Good morning, Patrick. Thank you for your questions. Let me first address the question around our VD strategies and turn it over to Kumar for your second question. So I first want to, with regards to the renew emphasis on business development, Just take a minute on the strategy and our thinking there. So it's important to note, I think we have a renewed organizational commitment to Transact with regards to business development. And this is from the management team to our board, and then obviously the two members of the management team, Peter and Glenn, that bring very relevant experience doing deals and really strengthens the overall ability for us to move this forward and execute on this key priority Obviously, it's one of BD and the renewed emphasis is one of our four key pillars of value creation as we see, you know, the urgency and conviction to deploy our capital, put it to work, to generate sustained value. So I want to ask, you know, Glenn to comment on thoughts on capacity, where we are there, and Peter with regards to what's the strategic focus of, you know, what we are considering.

I mean, capacity, we actually have quite a bit, given our cash balance and our ability to borrow as well. And obviously, not preferred, but we can always use stocks. So we have quite a bit of capacity. And size deals, I think, are not a limiting factor.

And with regard to strategic focus, it's really an evolution. It's an evolution of our strategy. It's a refinement. it's not a major pivot sort of in the road. And Peter, if you want to sort of highlight what we're thinking in that area.

Yeah, absolutely. So there's a number of criteria that we're looking at, but I also want to say we're also willing to be opportunistic and keep an open mind to other opportunities as well. But in terms of the areas of focus, it is, of course, revenue potential, especially near-term revenue potential, especially in the 2020 to 32 timeframe. So that implies something that's in the phase three or registrational phase or even on market, quite frankly. And then, you know, we're big believers that the types of things we should look at are things that are related to our core competencies. And we feel we have many core competencies. But clearly in the sleep-wake space, we've demonstrated a lot of success. and we'll continue to demonstrate success in that space. Also, because narcolepsy is in the rare orphan CNS space, we believe that capability can be applied there. We've also been building an epilepsy presence, and so that's an area of focus for us. in a variety of different epilepsies. And then certainly other things that are adjacencies to all of those within the CNS space that we believe we could leverage our core competencies. And we are agnostic to deal type. We're looking at M&A, we're looking at licensing, we're looking at collaborations. So we have kind of a broad aperture in the way we're thinking about accessing and sourcing some of these deals. And then I will also say while our focus is very heavily on near-term revenue, We are also in parallel looking at bolt-on opportunities that fit nicely within our current construct. And so that hopefully gives you some color. And I'll also just end by saying we have a really strong BD team and really strong capabilities that we plan to mobilize and put into action with this renewed focus and commitment from not just this management team, but also the board.

Yeah, thanks, Peter. Thanks, Glenn. And in addition to the strong business development team, we also have a very strong commercial engine. So, you know, any of these potential bolt-ons or on-market opportunities, we've always wanted to utilize that commercial engine and put it to work in terms of generating, you know, more revenue. So, Patrick, I said Kumar to BP205?

Yeah. Good morning, Patrick. Great question on the broader CNS indications. All the central disorders of hypersomnolence are the logical, natural choice for RxN2 receptor agonists. We are also excited at the potential for RxN2 receptor agonists in broader CNS indications. And to a large extent, LILI's acquisition of centers have validated the potential for this class of compounds. We are looking at mood disorders, cognition, fatigue, and ADHD in a preclinical setting. In terms of your question regarding what kind of SAD clinical PK data we would like to see, as we have mentioned earlier, BP205 has demonstrated a potential best-in-class in the preclinical setting. High potency, great selectivity, favorable preclinical safety pharmacology and toxicology and potential for one-stage dosing. So in the clinical PK setting, we'll be looking at TMAX, CMAX, AUC, half-life, safety and tolerability to the extent we can infer based on a single-dose study. Thank you.

Thanks, Kumar.

Thank you. Next question comes from the line of Corinne Johnson of Goldman Sachs. Your line is now open. You may ask your question.

Good morning and thank you. Maybe as you look at business development, you've been highlighting the importance of relatively near-term revenues, but I'm curious where the path to earnings accretion factors in for deals that you might consider. And then separately, could you just expand a little bit on the newest Patolisin formulation and the types of delivery models that that formulation could enable? Thanks.

Good morning, Corinne. Thanks for your question. Glenn? Yeah.

In terms of earnings accretion, I think what you should It's hard to answer that one. What I will represent is obviously you have to be looking at returns and invested capital that are quite substantial, which would obviously have to be loaded into teams. So that would be the main criteria over time. So we wouldn't be just doing a deal for the purpose of growth. We obviously have to have financial returns. Hope that answers your question. Thanks, Glenn.

And Karim, with regard to the new amorphous form of Pitocin, and so that was part of the value of the Novidium license. And we saw, you know, really an opportunity. We always talked about adjacencies beyond orphan rare, with obviously this very strong product, you know, this differentiated, you know, molecule weight that's being very successful in the market in narcolepsy and opportunities to go abroad. So with that, you know, we saw... new form and potential new formulations, new modes of delivery to develop, you know, with the Novidium license, the amorphous form. And Kumar, additional thoughts on, you know, directionally where we're headed there.

Yeah, thanks, Jeff. Karim, to answer your question, good morning, by the way. The physiochemical properties of our amorphous formulation could potentially lend itself to a different mode of oral delivery. resulting in a PK profile that may be more favorable to some of the indications that we plan to target within the broader CNS space. That's all I can say at this stage of development. Right now, we are optimizing the formulation towards the phase one PK study. Thanks, Kamal. Thanks, Karan.

Thank you. Next question comes from the line of David Hong from Deutsche Bank. Your line is now open. You may now ask your question.

Hey, this is Sam on for David. Thanks for taking the question. Just a quick one on the OpEx front. Can you help us to think about the trajectory for OpEx for the rest of the year, given the slight uptick in cost of products sold from the innovating license and the step up in R&D from the amorphous formulation license as well?

Thanks. Yeah. In terms of gross markets, obviously, they're going to be impacted by the Novidium contract. And then we obviously also have step-up royalties related to Prejet. But nothing abnormal beyond that year-over-year gross-to-net. We don't anticipate anything dramatic changing there. With respect to R&D, we would, in fact, expect a ramp-up in R&D expense as we move forward on on these trials and accelerate these trials. And then with respect to, you know, the rest of the P&L, I would not see, you know, substantial increase in run rates in terms of .

Hope that helps. Yep. Thanks. Thanks, Brian.

Thank you. We have the next question. Comes from the line of of UBS. Your line is now open.

Good morning. Thank you for taking my question. In one cue, it seems like you saw more friction than usual in terms of access, which may have led to the softness in the patient's numbers. I'm curious if you saw any changes in the discontinuation rate. And as a follow-up on the orexin agonist program, so now there are several orexin agonists that are either approaching approval or in late-stage trials in narcolepsy and IH. So for BP205 or DOE, It has the most potency among the competitor orexin compounds based on preclinical data. It seems like the sleep-wake space may be very crowded with a number of orexin agonists by the time 205 launches. So just curious here, instead of going head-to-head in those core indications, could it make more sense to just prioritize other indication first where you might have a clearer differentiation or even a first-in-class opportunity? Thank you.

Yeah, thanks for your question. With regards to the Q1 dynamics, let Adam share thoughts on that, as well as in terms of the commercial perspective on the continued opportunity with BP205.

Okay, sure. Thanks, Jeff. Yeah, so in one queue, we typically see these market access-related headwinds, but to be clear, you know, our coverage has not changed. We enjoy very broad coverage, over 80% of lives in the U.S. And actually that coverage was strengthened in 2025 with some improvements in some of our key payer accounts. So that remains the same. What happens is as consumers enter the new calendar year, sometimes they've got to go through copay resets. They've got to reestablish coverage or prior authorizations. Sometimes they switch plans. And that dynamic can simply just delay everything. some of the patient starts, which is gonna affect your average patients for the quarter. That's something that we see every year. It's really no surprise. And I think you asked specifically around DC rate and persistency. Persistency on WAKIX has remained very, very steady for many years, and we have not seen any meaningful change in that dynamic for a very long time. So it's really just these delays and patient starts as we start the new calendar year. And then from an orexin standpoint, kind of a commercial perspective around BP205, I think we're excited that there still is an opportunity to deliver an orexin that can deliver on the promise of orexin level efficacy, but potentially with a better safety and tolerability profile and once a day dosing across all three domains, NT1, NT2, NIH, with a single compound. That's really where we're excited and where we're focused.

Sure. Thanks, Adam. And a final comment on BP205 and the question. It's not sort of either or. We see this opportunity in terms of the development program, you know, both looking at central disorders of hypersomnolence with BP205 as well as the broader program, you know, that we are working on in addition to some of the broader CNS indications, as Kumar alluded to earlier. So not either or. we will look to invest in this significant opportunity across the erection to agonist program.

Thank you. We have the next question. It comes from the line of Jason Gerberry of Bank of America. Your line is now open.

Hey, guys. Thanks for taking my questions. Just a question and a follow-up just on the WACIX IP situation. So, If AET does get a non-infringement, the decision in the second half, just wondering about thinking about scenarios and what actually are barriers to an at-risk launch in second half 27. And then as a follow-up, just can you talk a little bit about the diligence that you did just to ensure that the, I guess, this arrangement survives any FTC scrutiny? If you can describe a little bit of the history of the license with Novichim versus the settlement agreement that you reached with them during ANDA litigation? Thanks.

Yeah, so first on your question with regard to AET and various scenarios, just as a reminder, the 30-month stay ends in February, and so we would expect February of 27 to be clear. So we would expect that the judge will issue her ruling on the ANDA case somewhere around there. And then of course there's appeal opportunities that both parties have for adverse outcomes for either party. So fully expect that there would be appeals. Certainly we would appeal if there was an issue there. But then also please keep in mind that this second trial just started and it could take 24 to 30 months in and of itself plus an appeals process. And so that kind of gives you a sense of the timelines and in our view in almost every scenario we end up with exclusivity that gets us into 2030 again inclusive of the six-month exclusivity and so hopefully that gives you some sense of the timelines and the impact and again we're going to vigorously defend and use every every right that we have to defend our multi-layer IP strategy, and that's what we're putting in place.

Thanks, Peter. And Jason, I would just add that in terms of AET and an at-risk launch, we really can't comment on other parties and what their decisions would be in that regard. And with regards to your question about the antitrust aspect, we obviously always consider that very closely. But most important to remember, when we saw the NVIDIA license and the amorphous form, the original opportunity we saw was a bona fide development program, which we've already initiated. And that was the opportunity when we did that license in January before what we learned at trial in February. And we continue to pursue that business and development opportunity with the NVIDIA amorphous license.

If I may just add to Jeff's point just on the at-risk launch, of course, there are legal remedies that we have access to that we would fully implement in that. See how vigorously we are defending our intellectual property and we would use every tool available.

Thank you. That will conclude our question and answer session. I will now turn the call back over to Dr. Jeff Dano, CEO, for closing remarks.

Thank you, operator. And thanks, everyone, for your interest in Harmony Biosciences. And have a great rest of your day.

Thank you, ladies and gentlemen. That concludes today's call. Thank you all for joining. You may now disconnect.