Insmed Incorporated ($INSM)
Earnings Call Transcript · June 9, 2026
Earnings Call Speaker Segments
Unknown Analyst
AnalystsAll right. Perfect. Thank you, guys, all for joining us today. I'm Lyla Bibi, I run our Healthcare Equity Capital Markets, and I'm obviously thrilled to have Will Lewis here, CEO of Insmed. I've got a ton of Q&A in the 35 minutes we've got, but Will, maybe before I kick off anything upfront you want to say?
William Lewis
ExecutivesWell, for those that haven't noticed, there's been a bit of a disconnect in the market. And I would say just as a general point for everyone to take away while the narrative that is out there is sort of exploratory about whether there's something going on with the launch or this is happening or that metric is right or wrong. I would just draw your attention to what our statements have been and what I will reiterate today, which is that the launch continues to perform exceptionally well. We are steady as she goes. Everything is on track or ahead of our internal benchmarks. And that gives us great conviction in the guidance we provided, both for the year and for peak sales for BRINSUPRI and more broadly, for ARIKAYCE, for TPIP, everything continues to progress on track or ahead of schedule. So we feel very good about where we are. We're aware that there is some confusion in the market about messaging, but I want to just clear all that up and let everyone know things are going extremely well.
Unknown Analyst
AnalystsThat's a great segue. And I think maybe we'll start just with a $1 million question, right, as we think about the BRINSUPRI launch. And obviously, you've had a tremendous start as you think about the commercial sales, first quarter sales $208 million, over 5,000 cumulative prescribers, 7,800 new patient starts, like amazing. But despite that, obviously, the shares have underperformed. And so as you think about what's being misunderstood or underappreciated, what are you most focused on?
William Lewis
ExecutivesYes. I think if you just think about the arc of the launch itself, from the beginning till today, we are on track for having just an absolutely stellar launch in the sense that this is going to be top 25 of all time in the industry. And that we're going to end up doing $1 billion plus in sales in the first year of launch. So those are just remarkable and impressive statistics. Now within every launch, there are always things that you can do a little bit better or improve upon. And certainly, we remain focused on that across all of our metrics. But market access is good. The narrative around the medicine is good. We note right now that about 1/3 of the patients that go on this drug experience symptomatic benefit in the first 2 to 4 weeks. So that plays really well into the broader adoption of the medicine as that message gets distilled and understood. And ATS, which just took place was a big success for us with a lot of positive feedback from physicians about those experiences and the appetite for physicians to write for patients.
Unknown Analyst
AnalystsThat's really helpful, Will. Maybe just one -- maybe just drilling down on one of the thematics that we've seen, obviously, a lot of noise around, which is discontinuation. And as you think about the narrative in the market, as you think about what you're actually seeing in terms of commercial impact, how do you distill the main drivers of discontinuations? When are you seeing it happen? Is it early in the treatment course or a few months in? Anything contextualizing discontinuation rates?
William Lewis
ExecutivesYes. So what we often refer to as either the discontinuation rate or its shadow, which is the continuation rate. by all benchmarks, we are doing exceptionally well. We are ahead of the metrics we had internally when we set our guidance, both for revenue for the year and peak sales, and that continues to be the case. When we look at where discontinuations do occur, it is usually early in the use of the drug. And we know from their self-reporting to the specialty pharmacy why they are dropping out. For example, about 1/3 of them drop out because of adverse events, which is exactly consistent with what we expected would be the case based on our Phase III clinical trial experience. When we look at the balance of why they discontinue, it's often due to loss of patient follow-up or a patient just discontinues and does not report why. Now both of those are interesting because while they represent roughly 50% to 60% of discontinuations that take place, those are things we can address. We can reengage with these patients from Q4 to Q1, you always lose patients due to insurance coverage changes or resets. So there's opportunity there that we have focused on, where we've already seen progress and improving getting those patients back on medicine and understand that when patients drop off this medicine, they are going to have another exacerbation. That's the nature of this disease. And when that happens, they're going to return to the hospital or to the pulmonologist. And at that moment, the physician is going to say there's only one medicine you can take that will prevent these exacerbations. And you were taking it before and you dropped off, go take it again and stay on it for longer to see that benefit. And I think that narrative is going to support return to use of the medicine because the patient is going to be forced to face that choice every time they have an exacerbation.
Unknown Analyst
AnalystsSo maybe building on that, as you think about the work that your field force is doing to promote treatment persistence, what's the feedback you're getting from the physician community? How are you thinking about the activation of the field force in terms of educating both the prescribers and then obviously, patients?
William Lewis
ExecutivesSo we have actually 6 different items and steps that we take to educate physicians, to motivate patients to stay on drug. It includes welcome packs. It includes when they opt into our patient support group, there are nurse practitioners that can reach out to them, to talk to them about what their experience is going to be like. There are lots of different tactical moves we've made to look for ways to improve upon what is already a very good continuation rate. And I think that's going to continue to be the case. When you talk to physicians in surveys, you'll often hear of numbers that are far, far lower than that. And I think for many physicians, that is the case. The experience is a very positive one. If we're going to be self-critical, we would probably say that we talked about the continuation rate a little too early in the launch. It was at the end of the first quarter after only 2 quarters of experience and that's a little early to be giving you a continuation picture that is accurate. So I think after a full year, we'd be in a better place to perhaps make more detailed commentary about that. But I want to be really clear, we are at or ahead of all the benchmarks we are looking for, for continuation. And that relative to benchmarks, continues to set a standard for excellence in our launch.
Unknown Analyst
AnalystsYou've noted, I think, previously about 80% of the patients on BRINSUPRI opt into the [ inline ] program. And so what support does that provide? What kind of interactions does it enable with patients that could drive this point further adoption penetration continuation?
William Lewis
ExecutivesYes. So there is an opportunity for there to be some nurse practitioner appropriately compliant, informed education to the patient about adverse events, what they can expect, we have the ability to engage with those patients, regular check-ins. Are they having any issues with their medicine? How can we be helpful the support is really white glove from start to finish. And the ambition here is to make sure the patient has the most success with the drug that they can. That is going extremely well. The opt-in percentage of north of 80% is extraordinarily high in our industry. Normally, you might hope for 50%, if you were in a good place. So we're way above that benchmark as well. That means we have a very good connection to a lot of these patients, and it gives us that opportunity for interaction. Notwithstanding that, the continuation rates that you've heard of, I think, as I mentioned before, are probably the subject of a little too much attention at this stage of the launch because things are going extremely well. We expect them to improve from here. And the evidence that we have for that is that some of these tactical adjustments we've made, we've already seen that.
Unknown Analyst
AnalystsThat's great. On the earnings call, you shared internet has already penetrated about 25% of prescribing physicians, over 5,000 prescribers. And of that, 20% of the prescribers have written scripts for at least 5 patients. For the remaining 80 of your active writers that are currently operating at lower volume, what is the typical feedback that you're getting from the clinicians that really require them to move to broader volume?
William Lewis
ExecutivesYes. And this is the biggest opportunity we have with this launch. Notwithstanding the performance we've shown in terms of revenue production, patients reached, physicians reached, we have good depth and breadth of prescribing already. But the opportunity here is to continue to ramp that up, and there are a lot of physicians and a lot of patients left for us to go after. Those physicians who had experience during the Phase III trial are the most active writers that are in our physician group. Those that are trying it for the first time are following what we call sort of the trialist playbook, which means that they'll put between 1 and 5 patients on the drug, see how they do. And when those patients come back into their office for the next checkup, which could be in 2 quarters, it could be in 3 quarters, one quarter, it varies by patient and severity, but when they come back in, that feedback loop back to the physician is what motivates the physician to write the prescription again. And that's why events like ATS and [ Chest ] where their academic gatherings of these physicians are really powerful because they give them an opportunity to trade stories about what it's like to use the medicine and having just come from ATS at the end of May, I can tell you that those stories are almost universally positive. We hear very good things about the drug from physicians and patients, and I think that just bodes well for the launch to continue. You mentioned the 80% of physicians who have written fewer than 5 prescriptions, to give you a sense of where we are, our Tier 1 physicians have more than 100 patients in their practice. So if we have some of those physicians who have written 5 or even 10 prescriptions, we have a huge amount of additional depth that we can go after. In the mid-tier, Tiers 3 through 7, it's largely -- you get into the community level physician. And what is important about the launch so far there is that we have already reached more than 5,000 physicians. That means if there are that many that are writing prescriptions that the mid-cycle of the launch is going to be strong because those are the physicians you need to be writing 1, 2, 3 years into the launch. And it's important that everyone understand, we're talking about an addressable market of 500,000 patients as we identified 3 years ago. This market continues to grow. It is not static. So the 500,000 patients are growing every year because of population growth, increased diagnosis, increased number of exacerbations, shifting them into the 2 or more exacerbating patients and importantly, these patients do not have a high mortality rate. That means that they are on drug, they stay on drug longer, and you do not lose the prevalence population to a high mortality rate like you do in PAH or the incidence population gets added to the prevalence population every year, and it continues to expand. And this is all before we go after what we refer to as the second launch, which is targeting the comorbid COPD and asthma patients in getting the physicians to do CT scans, diagnose the bronchiectasis and put them on label for our drug. That is a second wave of patients that we think is going to be very significant in '27, '28 and beyond.
Unknown Analyst
AnalystsI'm going to touch on that. I want to come back to that topic in a moment. Maybe just one question, just even as you were just walking through sales force framework prioritization, as you think about second half of '26, how are you prioritizing or shifting resourcing between existing prescriber depth and penetration versus new prescriber reach?
William Lewis
ExecutivesYes. So the clear statement to our sales force is for Tier 1 or Tier 2, it's about depth. And for Tier 3 through 7, it's about breadth. And that's how they're focusing and deploying their time. And all of our calling efforts are centered around those 2 themes. And that so far is doing very well. I will say that I think what I'm going to be watching very closely in the second half of the year is to what degree does this begin to self-actualize, without input from us. What do I mean by that? When a physician decides that this is the drug for a symptomatic bronchiectatic patients without a therapeutic specialist pushing that agenda, that's when this medicine will begin to really take off because it means that the physicians are just looking for the patients where this drug can be used and it's not responding to the encouragement of a therapeutic specialist. And you see that sometimes happen earlier, sometimes a little bit later, but when it does, that's when the launch really starts to take off. And I'm excited about what we're hearing because that positive feedback loop suggests to me that we may be able to see that in the course of '26 or '27. And I'll just drop a quote that I heard from a physician at ATS that I've been sort of hesitant to mention, but I'll share it here. He said -- he goes, congratulations, you have the statin for the lungs. And I think the reason they said that was because the ability to impact the inflammatory cascade of -- in the pulmonary setting, using DPP1 inhibition is relevant for COPD, asthma, bronchiectasis, bronchitis, any form of lung ailment that is -- includes inflammation. This may be able to have a role to play. Now for them to be on label, they have to be diagnosed with bronchiectasis, and 2 or more exacerbations is the market access standard. But from all of those different types of disease, I think there's a perception that this drug could really become a cornerstone of treatment for ailments. And as long as they have bronchiectasis, that's a compliant and appropriate way for us to target patients.
Unknown Analyst
AnalystsAnd what are you guys doing to that point as you think about just the significant commercial opportunity that asthma, COPD patient populations represent in terms of educating, in terms of broadening engagement and understanding -- having the physicians really understand the need really to drive increased diagnosis of comorbid bronchiectasis in that patient population because it is an enormous opportunity.
William Lewis
ExecutivesYes. So let's talk about the scale of the opportunity and then talk about how we're approaching it. When we talk about the addressable market, we identified it 3 years ago at 500,000 patients. As I said a moment ago, that's dynamic. It is growing every year. We talk about the asthma and COPD population. Let's just take COPD. There are 20 million patients in the U.S. with COPD. They're out there are sort of all over the place right now, but my best guess is somewhere around 20% of COPD patients are also comorbid with bronchiectasis. Now we're doing work right now as our other groups to validate that number. There are some that put it much, much higher, some that put it a little bit lower. But let's just say it's 20%. That's 4 million patients or 8x the size of the addressable market we are targeting out of the gate. That's why we are approaching this comorbid population as a second launch. And in that sense, we are aware this is going to take time to get those patients into the top of the funnel. It's going to require a CT scan and a diagnosis by a pulmonologists. But once those are completed, if the patient is symptomatic, they are absolutely appropriate for treatment. And that, we think, will [indiscernible] benefit to years '27 and beyond as we think about where this drug could go. By the way, the $5 billion in peak sales does not include the contribution from those 2 comorbid populations. So this is substantial potential upside that we're going to be tracking very carefully and resourcing very deliberately to go after.
Unknown Analyst
AnalystsIt's an amazing undertaking for these patients. Maybe the last question before we shift gears to talk about ARIKAYCE. You've noted in the scripts for April, I think this is part of the earnings call, it's tracking with what Symphony is reporting, which is a metric you don't typically provide. How are you thinking strategically about the extent of information to share on the progress of the launch versus, I think, candidly, what can be misinterpreted, broadly speaking, by the Street, and so how do you expect to really continue to point investors to the direction of -- Symphony went in line with your own projections? How do you think about that balance?
William Lewis
ExecutivesYes. So today, because we're at a public forum, I can update you. We are continuing to track the [ Symphony TRx ] number. it is proportionately right on top of where we are internally. So if you want a good proxy for how we're doing, look at the Symphony TRx number on a proportionate basis, and that will give you a guidance about where we're headed. And what you'll see there is that things continue to be positive and up to the right. So we're very encouraged by that. As we think about what data provide, I think we've learned a lot in terms of communication and what works and what doesn't. And what is clear is that when we try to provide additional anchor points or references of additional data, that tends to confuse more than clarify. Consequently, we are going to stick to new patient adds, which we have told everybody for guidance purposes, they should model as organic demand at 6,300 patients every quarter throughout the rest of this year, and that will get you above our guidance of $1 billion in revenue. Beyond that, we'll be providing revenue. We'll provide qualitative description of what's happening relative to our internal benchmarks and our dashboards, but we're not going to go into detail beyond that. It tends to be confusing, and it ends up raising more questions than answers despite our best intentions to be transparent and give more insight, that's kind of backfired and everyone has seen that in the marketplace. But the unfortunate part about that is every data point we've been putting out and every message we've been trying to convey is that the launch is going extremely well. And so the market correction to us is at odds with the performance of what's happening internally. And even as we pursue that messaging, we continue to improve upon our launch. So it's not just that we're in a static good launch mode, we're working every single day to try and make it even better, and I think making some real progress there.
Unknown Analyst
AnalystsNo, that's very helpful, Will. So maybe with that, we'll turn to ARIKAYCE. You've had obviously impressive ENCORE data earlier this year, which positions ARIKAYCE for a significant commercial expansion. Maybe spend a few minutes on the regulatory front alongside the sNDA filing in the second half of this year, you've noted plans to request conversion of ARIKAYCE's current conditional label in the U.S. to traditional approval. Can you speak to the progress made to the regulators, any refinements around timing, assumptions for first-line launch?
William Lewis
ExecutivesYes. So you should model next year for first-line launch, both in the U.S. and in Japan. And we feel very good about both of those, the progress we're making with regard to that. By the way, the same is true for BRINSUPRI. BRINSUPRI will be launched in Japan starting next year. And so your model should include Japanese revenue for BRINSUPRI and for ARIKAYCE in frontline. Why is that important? In the case of Japan, we're talking about 150,000 patients with diagnosed with bronchiectasis. And remember that the Asian population are hyper responders to DPP1 inhibition. So whereas in the U.S., it's a 20% reduction in pulmonary exacerbations that BRINSUPRI is documented in Phase III. For Japanese patients, it's 65%, more than threefold better reduction in exacerbations. So the uptake, we expect to be very good in Japan. And in addition, there are more diagnosed NTM patients in Japan than there are in the U.S. So being able to expand the market over there for both of these and launch both at the same time with a proven commercial sales force we think is very encouraging and will [indiscernible] benefit to, obviously, our numbers next year. I think ARIKAYCE in the U.S. is going to do very well. We're still trying to figure out what the shape of that launch curve is going to look like. The target product profile, which we now have, makes a very strong case for early adoption, but we'll have to see what the picture looks like and whether it will be a slow adoption or a more rapid adoption. We'll have some more guidance about that as we get closer to the launch. But clearly, if you can get an 80% of the patients to culture convert in 6 months versus once they become refractory at 30%, it makes a strong case for intervening earlier. And our expectation is that, that's what we will see.
Unknown Analyst
AnalystsFantastic. Maybe we'll move to TPIP. And so you have 4 Phase III TPIP trials, 2 of which are underway already in PH-ILD and PAH. You plan to share the open-label data for the Phase IIb trial in PAH in the third quarter, where 7 patients have up titrated. And -- can you level set maybe for the group expectations into the data, what is the average duration patients have been on treatment? What are you expecting to see more patients reach the max dose at this time point?
William Lewis
ExecutivesYes. So I'm very excited about Q3 for the TPIP data update. I think that's going to be significant. Why am I excited? Because this is one year in the open label on drug. So for patients who've been on drug for the initial time of the trial, this looks at their performance one year later. Have they stayed with good performance and as the adverse event profile remain benign. For those patients who have titrated higher, do we see continued improvement in performance. For those patients who were on placebo and went on drug, how did they perform? The data we're going to provide are things like NT-proBNP, 6-minute walk, a functional class change and improvements, those things will all be available for the population of just under 100 patients. Let's dig a little deeper into those patient profiles and what we're going to expect to see. While we did not encourage up titration in the open-label study, it was available to physicians at their discretion. And we were pleased to see that 25% of the patients actually increased the dose above 640 micrograms, which was the max tolerated target dose in the original Phase IIb study. In addition, 7 of the 91 patients went all the way up to the 1,280 max dose of the drug. So we will have data that looks at a group of patients that have gone all the way to the top. What is the safety profile? What's the efficacy profile? For those patients that increase their dose, do we see continued improvement because that will lay the groundwork for a very strong case that this is going to be a drug that's going to dominate in each of these 4 indications. And I'll remind everybody that for all Phase III 4 -- all 4 of the Phase III trials, 1,280 is the target dose, and we have expanded the time for patients to be able to get higher in dose. We believe that going higher will always provide better efficacy for these patients. And so we want to make sure that, that window is available. And so far, so good. This is a 1-year look. We'll have another 1-year look a year after. So we're going to continue to get data from this trial. We obviously won't have PVR data, pulmonary vascular resistance data, because we don't -- we are not doing the direct measurement, that's so invasive. But it's important to ground ourselves in the understanding of the baseline profile of this drug. This drug had a 35% reduction in pulmonary vascular resistance compared to sotatercept, which was just under that, 33%, 34%. So the best available drug right now we beat on this most important measure. Relative to other prostanoids, we're 15% to 20% better. And I don't mean relative. I'm talking absolute better. They are in the teens. We were at 35%. There really is not a close competitor in the prostanoid class based on the available data today. I welcome the introduction of other medicines and their clinical data to make the case as to what is going to be the drug that's going to dominate in this area. Right now, we look at sotatercept with peak target sales of $8 billion and a very strong launch, targeting only PAH. We are targeting PH-ILD, IPF and PPF. If we have a best-in-class drug in those 4 indications, you can expect TPIP to be a very important commercial driver of this company's future. And so that's what gets us so excited about today. We sit here with ARIKAYCE, BRINSUPRI and TPIP. The next 5 to 10 years of this company's existence, are going to be revenue growth up and to the right from all 3 of these franchises. Two of them are first in disease, the other is best-in-class, and all 3 of them are the same call point. So the leverage we're going to get at the EPS line is going to be significant starting next year when we go cash flow positive. And we have said publicly, we do not intend to raise capital between now and then. So it is a very bright picture for us from here, and that's why it's so frustrating for all of us, including our shareholders who've watched the volatility in the stock recently because from our point of view, performance is steady as she goes, is very, very good, nothing new to take us off that track and we see the future of the addition of ARIKAYCE. We see the future of the addition of Japan with BRINSUPRI and the future of the addition of 4 Phase III trials for TPIP, creating another blockbuster drug in our franchise. And that's just what we're sitting on today.
Unknown Analyst
AnalystsMaybe on that point, just think about how the competitive landscape has obviously evolved, right, as you think about IPF, recent approval of [indiscernible]. How do you think about that? Could that potentially impact enrollment in the trial? How do you think about that in terms of background therapy to your trial, anything that you're seeing sort of evolved in the treatment paradigm?
William Lewis
ExecutivesYes. I think what's interesting about IPF as an example, a fatal disease, the available drugs are impactful, but there's a lot of opportunities and a lot of unmet medical need that still remains. This is a disease that's been targeted for a long time by a lot of different companies, the [ TETON ] data that came out from [ Uther ] was very exciting because it showed that prostanoids, the higher you go in dose, the more effective you are at treating the IPF condition. We can get more drug into these patients' lungs than anybody and that we have established with clinical data already. As we go into IPF, which we have not tested our drug in, we know that if we can get higher doses, we should see better performance. And that's why we're excited about the Phase III trial that allows us to go up to 1,280 micrograms, which is multiples of what the competition is able to do. In the end, the enemy here is the disease, not the other companies. So we welcome the other drugs and their clinical data, and we look forward to the comparison of what we were able to do versus others because we have a lot of conviction that this drug is going to really deliver. And one of the important things to remember for this profile of patients is that the safety is just as important. So it's not just about pushing the dose and getting a lot of drug in there. It's how do they respond. Do they have serious issues with cough. Are they adherent to the use of the medicine. There is a competitive drug out there just to [indiscernible] the TETON study. That drug, you have to get in 7 to 10 breadths each time, each of those 4 times during the day. That means 28 to 40x every day, you're breathing in their drug. We do it once, and it covers the patient for 24 hours. And because the drug is inert when it is inhaled, the AE profile so far has been better. And the reason we say that is because what really triggers that cough reflex is the active drug in the upper airway. And because our drug is inert, they don't have that experience. So we're excited to continue to look at safety in the open-label extension. We're excited to look at the Phase III trial. I can tell you the enrollment, which was a question we get, are you going to have concerns about enrolling? We don't think so. What we're hearing right now is that physicians are very excited about using this drug and putting patients on it in clinical trials. And what we note from the PAH and PH-ILD studies, is that physicians, even in the U.S., are putting patients on drug. Why is that relevant? Because there's already an approved medicine that is a prostanoid in the U.S. available for those patients. and physicians for this fatal disease are still willing to put them on our drug where they may be on placebo for 6 months before they get our active drug. That should tell you the level of enthusiasm they have for what that drug will ultimately do to that patient when they finally get it.
Unknown Analyst
AnalystsIt's amazing just to think about how much you guys are executing against commercially as you think about your late clinical stage trials. And then on top of it, we should spend a few minutes on your early-stage pipeline, which is pretty remarkable as you think about yet another pillar of growth. We know you're running 2 Phase I trials evaluating gene therapy in DMD and ALS, where you've indicated updates in '26 and '27. Share a little bit about what gets you excited about these programs, particularly as it relates to intrathecal delivery? And really, to the extent you can share perspectives around what data we might see in those updates?
William Lewis
ExecutivesYes. And I would take a strategic step back at this moment and remind everybody that about 5 years ago, we did half a dozen acquisitions. These are different platform companies. They were not very expensive at the time we acquired them. And the thinking has always dominated our business development efforts that you want to do business development when you don't need it. And so we had good ASPEN data. We had good ARIKAYCE data and performance. And at that time, we went out and did a number of acquisitions. They have been percolating inside the company for the last 4 to 5 years. And next year, you're really going to see the benefit of those efforts. So there are 4 different geographies that have independent platforms that are being pursued. One is synthetic rescue, and that's in Cambridge, England. That one is probably the furthest away from entering the clinic, but has some of the most profound science, cutting-edge technology that we are bringing to bear for diseases like ataxia telangiectasia, another neurologic condition that is devastating. And we're very excited about what that could be. In New Jersey, where we have our original scientists, we have successor DPP1s. So one of the things that's going to enter the clinic this year is a next-generation DPP1, what we call INS-1035 -- 33, sorry, 1033, we have over 1,000 of them. So give me a break. INS-1033, which is going to target rheumatoid arthritis and irritable bowel disease. So we're going into the clinic this year with that drug, that's our intention, and that will be the next generation of DPP1 targeting those significant opportunities. The third area is deimmunized therapeutic proteins where we're using, yes, here comes the buzzword, artificial intelligence to do B and T cell epitope deletion to make functional proteins not trigger the immune system and still have efficacy. The first area we're targeting there is uricase. So that's going to be for gout. Right now, there is a very effective drug out there. Uricase for the treatment of gout, but it only works in about 20% of the population. So this would be a way to bring that medicine to all patients who suffer from that condition. No one has really been able to de-immunize a therapeutic protein successfully to the best of our knowledge, we believe we've done it. We believe we've cleared the hardest hurdle there. And so we look forward to that entering the clinic in the next year to -- and then finally, the gene therapy operation, which is out in San Diego, that has 2 medicines that are currently in the clinic, one for DMD and one for ALS. As you mentioned, we will have data from those. We know the internal data that we're looking at between now and the end of the year, but really, we will feature that next year. What we are looking for there is clearly best-in-class performance. Matching the existing performance is not enough. So if we're bringing a medicine forward there, it is because it is materially better than everything else that we've seen out in the market, should be better safety, better efficacy. And so far, having dosed all but the last patients in the final cohort I would say, so far, so good with those ambitions. ALS, we are starting in sporadic patients. This is important because the ALS market, as you know, for SOD1 patients, it's about 2% to 3% of the overall ALS market. But because we saw in our early neuronal cell assays, performance in sporadic patient samples, the FDA agreed that we should be launching this in a clinical setting first in sporadic patients than in SOD1 patients. So if we see performance in sporadic patients, we're going to have another blockbuster on our hands, and that data will be available next year. So we're very excited about those. There are a number of other programs behind it. I would just say that I think we have found our rhythm in terms of the research operations in the company, and you can expect 1 to 2 INDs a year, every year from here going forward without any additional business development externally.
Unknown Analyst
AnalystsIt's amazing. And so maybe just in closing, there's obviously so much that you guys are prosecuting, both in the context of BRINSUPRI, ARIKAYCE expansion, a number of early-stage TPIP and early-stage pipeline. What are you most excited about?
William Lewis
ExecutivesI would say just the regular way performance of the BRINSUPRI launch, I mean that just continues to impress me relative to our own ambitions, which were pretty lofty when we started. And the team has just done a fantastic job. That excites me the most because it lays the groundwork for the expansion of ARIKAYCE, the arrival of TPIP. These physicians we call on and the medicines we provide are having a material impact on their patients for the better. And every time we do that successfully, we make a positive impression. And because all 3 of our late-stage franchises have the same call point, we have the ability to have a really positive influence there and continue to build on our reputation.
Unknown Analyst
AnalystsIt's amazing. You've obviously done transformational work in the context of your clinical development and obviously delivering transformational medicine for patients. So thank you for all that you do. We're super excited for the future for Insmed.
William Lewis
ExecutivesIt's our pleasure. And I would just say, I hope everyone understands how enthusiastic we are about where we are as a company. I think there's a major dislocation right now in value versus operational performance, and we hope to continue to educate about that.
Unknown Analyst
AnalystsYes. Well, execution through value. So, yes, thank you.
William Lewis
ExecutivesThank you very much.
Unknown Analyst
AnalystsThanks, everyone.
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