Morning, and welcome to the final day of the 2024 Jefferies London Healthcare Conference. It's my pleasure to now introduce Will Lewis, the Chair and Chief Executive Officer at Insmed. Thank you.
Good morning, everyone. Thank you. Before I begin, please read this forward-looking statement, disclaimer, and make reference to our public filings. Insmed is in a very interesting place at the moment because we are, as we like to say, at three for three. We have three of our four pillars that are in late or commercial stage development, each of which represents, in our view, at least $1 billion in potential peak sales revenue. Between Arikayce, Brensocatib, and TPIP, that means we're totaling north of $8 billion in peak sales in our best estimate. And each one of these is, to our mind, de-risked. So if you look at Arikayce, that's our product for the treatment of nontuberculosis mycobacterial lung disease. That is approved in the U.S., Europe, and Japan, conditionally in the U.S. for refractory MAC patients.
We are in the process, through a trial called ENCORE, of looking to expand that to frontline NTM, all MAC NTM patients, and that's how we get to north of a billion in revenue. This year, we have estimated we'll be doing between $340-$360 million in revenue, and we're on track to hit that forecast. The second drug is Brensocatib. That's a DPP-1 inhibitor that we licensed from AstraZeneca back in 2016, and that is certainly the cornerstone of the story for this year. That is the drug that gave us the ASPEN study that read out earlier this year in May and sent the stock up quite dramatically. That's for the treatment of bronchiectasis.
We'll talk more about that, but bronchiectasis, like NTM MAC lung disease, is a disease that has nothing approved to treat it, and our Aspen study showed a very clean win, both from a safety and an efficacy point of view as it relates to that disease, but it's important to understand that the real value of the DPP-1 inhibitor is that it is involved in any neutrophil-mediated disease. It has a role to play by impacting the body's response in that setting, so while we have the data definitively from bronchiectasis and the Aspen study, we also have another study ongoing on CRS without nasal polyps, and another one that's just kicking off on hidradenitis suppurativa, a dermatologic condition, and then finally, in our late-stage pipeline, TPIP, that's Treprostinil Palmitil Inhalation Powder.
That is a prodrug of treprostinil, which is going to be used for the treatment of pulmonary arterial hypertension or pulmonary hypertension associated with interstitial lung disease. That phase 2 data from PH-ILD read out earlier this year, right around the time of ASPEN, and PAH reads out next year. It's a very exciting time for the company because it's taken a long time to assemble this portfolio and get it into this position. We're very excited about what 2025 has in store for us. What we're talking about, and we see it on this slide, is a dramatic change in the addressable patients we'll be able to influence with our medicines. Today, on the far left, you see we treat a population globally of around 30,000 patients.
By the end of this decade, we anticipate that will exceed 2.5 million patients across the three products I just mentioned: Arikayce, Brensocatib, and TPIP. This is the slide I want you to walk away with in your mind today. 2025 and beyond really represents the harvest of all the work that Insmed has done for the last decade. And on the left-hand side, we see revenue generation that comes from both the expansion of NTM in Arikayce, but also the launch of Brensocatib, which should be a blockbuster product that will launch roughly in the middle of next year. And a huge part of the 2025 story for Insmed is this revenue launch that we expect will take place in the middle of next year.
But equally important, on the right-hand side of this slide, we document the different clinical data readouts that will happen in 2025 and the early part of 2026. The CEDAR trial, the BIRCH trial in CRS without nasal polyps, the CEDAR trial is in hidradenitis suppurativa, as I mentioned. Both BIRCH and CEDAR are successor indications to Brensocatib in bronchiectasis. As you look at Arikayce, that expansion I mentioned before, the ENCORE trial that reads out in the early part of 2026, that was paired with another phase 3 trial called ARISE, which gave us a read on what will happen in ENCORE. So we have a high degree of confidence that ENCORE will read out the right way because ARISE did, and this is a longer and more robust version of ARISE. TPIP and PH-ILD, as I already mentioned, we had phase 2 readout this year.
Phase 3 will kick off next year, and in PAH, the phase 2 trial results. So a lot going on on the clinical side as well as on the revenue generation side. This documents it a little bit more temporally, looking at when these events are going to hit in the first and second half of 2025 and the early part of 2026. But you can see from this slide there is activity across our entire portfolio, including the preclinical so-called Pillar Four. Pillar Four is an assembly of technology platform companies, and we believe we'll continue to throw off between one and two INDs a year over the next several years. The goal of Pillar Four in the preclinical category here is to answer the question, what's next after these first three programs? Let's dig deeper into Brensocatib and the launch in bronchiectasis.
We are very excited about where we are positioned with regard to this launch. We have done a lot of work with physicians, patients, and payors. We started this work on the assumption of success that ASPEN would read out positively. Indeed, it did. But what this has done is it's enabled us to be in a position to talk confidently about what that launch trajectory looks like. And what you see in each of these three critical categories is that it is a very positive picture for us. From the U.S. physician point of view, which is where we'll launch first, we have, in our research, found that 60% of physicians intend to prescribe this drug, and 80% are likely to prescribe it to their patients.
So this is going to be something where they're going to call their patients into the office to put them on our drug for the treatment of bronchiectasis. Patients are extremely motivated by this arrival of this medicine. There is nothing approved to treat bronchiectasis today. We'll talk more about the condition later. But we've had almost 40,000 patients come to our website and download information, which is stockpiling these patients at the time of launch. So we're very excited about that. And most important for any commercial launch is the impact of payors and the dialogue we've had there. That's been ongoing for over a year, and I can tell you it's extremely positive, what we are hearing in terms of the pricing, the perception of the drug, and its potential impact on patients.
The picture at the time of Brensocatib's launch in the middle of next year for bronchiectasis is extremely positive. As we look at the addressable market, this top line here indicates what we think is going to be available in terms of patients at the time of launch. These are patients with an ICD-10 code. We know where they are. They are already diagnosed with bronchiectasis. This is 500,000 patients in the U.S., more than that in the E.U., 500,000, and then in Japan, 150,000. Critically, for our launch, we already have the commercial infrastructure for each of these regions. We launched Arikayce, extremely successful launch, top 10 non-oncology rare disease launch of all time. And that same infrastructure is being supported and supplemented with additional human resources to be able to position us for the bronchiectasis launch.
We are scaled right now to have enough calling effort in the U.S. to be able to reach every pulmonologist in the United States. As you look at these lines here, the undiagnosed bronchiectasis is a subpopulation of asthma or COPD patients. So while we talk about 500,000 patients at the time of launch in the U.S., we actually think the market is bigger than that. And that is because patients who are on max dose LABA/LAMAs or otherwise treated for asthma or COPD, who are experiencing exacerbations, we believe are very likely bronchiectatic. And they are one CT scan away from being diagnosed as such and therefore on label. So while the initial target population is 500,000, we think the undiagnosed number is several million beyond that.
So this puts us in a position to be able to say to you today, we think this is north of $5 billion in peak sales. That's based on the 500,000 number. So this is a very big drug, potentially a blockbuster. As we look at subsequent indications, we're running the BIRCH trial for CRS without nasal polyps. There are 29 million people in the United States that suffer from this condition. There is one drug approved to treat it. It's an inhaled steroid. Steroid non-responders and patients eligible for surgery are the patients we're targeting for this indication, and that includes the first and second lines indicated here. You can see from the number of patients, 200,000 in the U.S. that are new surgical patients. This is annual incidence rate, so that's replenished every year, coupled with those steroid non-responders, the prevalence population in excess of 3 million patients.
What this means is that the CRS without nasal polyps indication is bigger than the bronchiectasis indication. And remember that bronchiectasis, we think, just with the indicated population is 500,000 patients at the time of launch and north of $5 billion in peak revenue. So we're looking at a very substantial drug and subsequent indication should the CRS without nasal polyps trial read out positively. That data comes out next year. Beyond that, we have the HS or hidradenitis suppurativa trial, and here we indicate both the target population and then the global diagnosed prevalence. Once again, it's hundreds of thousands of additional patients should that trial read out positively. Switching back to Arikayce, which is our approved drug, what's remarkable about this drug is that we are in our seventh year of launch, and we are still seeing double-digit year-over-year growth in revenue.
This is an acute treatment for a lung infection, and we're indicating $340 million-$360 million in full-year revenue guidance. That would be more than 15% growth over the prior year. We continue to be very bullish about our opportunity to continue to grow this brand in the upcoming years, and that is before we talk about the expansion into the all MAC NTM population. Right now, globally, this is about 30,000 patients. As we move into the all MAC NTM population, that's several hundred thousand patients. So this is going to scale up roughly five to seven-fold with the success of ENCORE, should it read out that way, by the beginning part of 2026.
Alongside bronchiectasis and Brensocatib and its subsequent indications, our first approved product, which is also pulmonology call point, has had very good double-digit year-over-year growth into the seventh year of launch, which I think speaks to the commercial capability of the company. As we look at this, I mentioned this a moment ago. The expansion from refractory MAC into MAC lung disease. What's noteworthy in this indication is that there have been several companies that have tried to also develop drugs in this space. We were the first and only approved therapy to treat this indication. We are the only drug that is indicated, strongly recommended for use in the guidelines internationally for the treatment of this indication. The other drugs that have come along have struggled to get success in the treatment in clinical trials, and that really speaks to how difficult it is to treat this indication.
Once this infection gets in your lung, it's extremely difficult to eradicate. Through our liposomal technology that utilizes amikacin and a proprietary nebulizer, we're able to get the drug into the distal portions of the lung, including the macrophage, which is where this infection is resident. And that is why we're able to be so effective in eradicating it. We see this as a market where we will be the dominant player for many years to come. So while our patents extend comfortably into the 2030s, we think it's unlikely we're going to see generic competition anytime soon. Our third pillar, as we refer to it, is TPIP, Treprostinil Palmitil Inhalation Powder. This is the sleeper drug in the company. We have had very good data to date in this indication.
I think because Brensocatib and bronchiectasis represents such a startling innovation and data set, it's hard for people to turn their attention and try to give us credit for TPIP. I always like to remind people that when sotatercept had its phase two data, it was bought for about $11.5 billion by Merck, very successful drug, very important innovation in the field of PAH. We think we're going to be able to treat type 1 and type 3 patients, so PAH and PH-ILD patients. This is a once-a-day dry powder. It's a 16-carbon chain appended to the treprostinil molecule, cleaved off by esterases in the lung when the inner molecule is breathed into the lung. That's incredibly important because what it does is it lowers the peak and extends the trough of this drug's PK/PD profile.
That gives the patient once-a-day coverage, daytime and nighttime, for the treatment of this disease. We are able to get to a level of treprostinil that is far in excess of what is available through Tyvaso or any other knockoff molecule that's out there. And as a consequence, we're super excited about this. We have seen PVR reduction in the blended blinded data in excess of 65% in some of our patients. We don't know if they're on drug, but I would say it's extremely unlikely that a patient is going to have spontaneous reductions in their pulmonary vascular resistance. And so consequently, we're very encouraged by that data that we've seen to date. We believe this will be the cornerstone molecule used as a prostanoid for the treatment of pulmonary hypertension, and our expectation is that it will be complementary to sotatercept, not in competition with it.
We know the population because this is a crowded space, but again, we expect to be the cornerstone choice for prostanoids in this area. PAH has a number of drugs that are approved to treat it. It is a fatal disease, so innovation there is still needed. What we have done with our molecule, we think, is to be able to add substantially to the ability to improve patients by them and really reach the intended goal of prostanoids when they were first innovated. The problem with treprostinil is a great molecule, but it passes through tissue very quickly. So it has to be readministered constantly throughout the day to ensure that it stays above a threshold level in the lung. Our formulation keeps it above that threshold for an extended 24-hour period. That's its innovation, and that's why we think it's going to be the molecule of choice.
What's remarkable about this space is that as crowded as it is and as difficult it is to find patients that are in this, once the physicians who treat these patients have seen our data, they are lining up to put their patients on this drug in our trial, and we've seen that in the form of accelerated enrollment in our phase two study, so very excited for this data to come out next year, and in PH-ILD, there is only one other molecule approved to treat it. It is treprostinil, Tyvaso. We think we're going to be much more effective than they are, then there's the fourth pillar. Not everyone's favorite sometimes. Sometimes their favorite depends on who you are, but this is really the answer to the question of what's next. It's a modest amount of investment now for true innovation.
These are platform technologies that look at things like synthetic rescue, deimmunized therapeutic proteins using artificial intelligence, gene therapies that are at or will be the cutting edge in the space. Our first one will be in Duchenne muscular dystrophy, which is an area we're particularly excited about. We're using intrathecal delivery for the treatment of Duchenne muscular dystrophy with gene therapy. That may seem counterintuitive, but the preclinical data we've seen is exceptionally good in terms of the ability to transduce tissues that are in the musculoskeletal system. We also have some other technologies that we've harvested that are looking at diseases like Stargardt and ALS, both of which we expect to file next year. This includes what's referenced here as the RNA end joining. As you know, in gene therapy, oftentimes the capsid limits your ability to create larger transgenes that can address bigger proteins in the body.
What we've done is we've actually created an ability to do two capsids and rejoin them inside the body so that you can create longer-length proteins. For example, mid or even full-length dystrophin for the treatment of Duchenne muscular dystrophy, which we think could be really profoundly impactful to these patients. We look at all kinds of innovation for the cost related to this. We're currently working on algae-based manufacturing of therapeutic proteins. This would obviously lower the cost dramatically, and that's another area where we'll be sharing more information next year. This is the key to what allows us to have a three-for-three win, and it is our culture. At the company, we have enjoyed a lot of real enthusiasm for the 12-year journey I've been on.
I always like to say when I joined Insmed, there were less than 30 people, fewer than are in the room right now, and we had a zero enterprise value, $75 million of cash and a $75 million market cap. So I felt like I could step into that role because there was really very little damage I could do at the moment. In the last 12 years, we've now grown to 1,200 employees, and we enjoy some of these accolades that you see on this slide, the most significant of which, in my mind, is the Science Award for the best employer. The only other company to get four years in a row was Genentech, and so we're very pleased to be in that place that they were many, many years ago.
I think the single greatest thing about Insmed, for those who are thinking about an investment in it, is that we are at the very beginning of our race. If you think about where we were a year ago, there was huge uncertainty around whether ASPEN was going to work or not and then what that data would look like. The ASPEN trial read out as perfectly as we could hope that it would. It was safe, it was effective, and it sets us up to prove that neutrophil-mediated diseases can be influenced by DPP-1 inhibition. And that opens not just bronchiectasis, which is a massive market opportunity, but also the other indications that we're doing the clinical trials in CRS without nasal polyps and HS. So it's a very exciting time.
We'll have both revenue generation next year and clinical data, and so 2025 should be a pretty exciting time at Insmed. With that, I'll stop and open it up to questions if there are any in the audience. On TPIP, do you have any read on IPF? Oh, so the question is, for TPIP, are we looking at IPF or idiopathic pulmonary fibrosis? That question comes often because there's a company called United Therapeutics who is running Tyvaso in a trial for idiopathic pulmonary fibrosis. We're believers that this is a pretty hard hurdle to clear. Fibrotic disease is, while theoretically one can understand why prostanoids, which are involved in vasodilation, would be beneficial in that setting, we're a little more skeptical. So I think our plan is to frankly see what their results are. If they are successful, then we will go after it.
I would leave you with this thought: anywhere Tyvaso works, we should work better, and materially so. And so if they are successful in IPF, you can expect us to launch a trial in that rapidly thereafter. Other questions? If not, I have 17 one-on-ones to go to for the rest of the day. So I'll thank you all very much for your time and attention.