Okay, great. Good morning, everyone. I think it's still morning. It's my pleasure to welcome Will Lewis on stage, CEO and Chair of Insmed. Will, thanks very much for coming. Thanks for having us. Excellent. I do have one point of admin for everyone, though. You should have had an app when you registered. If you have any questions you want to ask Will, please send me over those questions on the app. I will receive them on this iPad here, and that should help me ask your questions on your behalf. So, with that said, it's been a transformational year. Stock up nearly 150%. It's not many stocks you can say that would in biopharma today. I realize everyone here may not know about this performance, but maybe a good place to start and get everyone on the same page is, perhaps, can you give an introduction to the company? And we've just had your 3Q results. Perhaps just to set the stage of where the company sits today. Sure. So, the way to think about Insmed is as a company that has essentially four pillars. One, which is Arikayce, that's our approved commercial product for the treatment of NTM. That's commercialized in the U.S., Europe, and Japan by our sales force, which is important because it feeds into the second pillar, which is Brensocatib, the DPP1 inhibitor. That's the one that had phase three data this year that was very compelling and, as a consequence, really drove the stock to new levels. And that one is getting ready for, we publicly said, we'll file that in the fourth quarter and be launching around the middle of next year. Same call point as the first pillar, commercial infrastructure. And we'll have much more to say about those two and how they interact. Third pillar is TPIP. That's a treatment for pulmonary arterial hypertension. And we have the fourth pillar, which is our research arm. So, between those four pillars, we have an awful lot going on at the moment. And I guess if there's one thought I would leave everybody with, it's this idea that both are going to be reading out. It's not just what's happened this year. It's what is about to unfold in the next 12 to 18 months. We're going to have multiple clinical data readouts in late stage leading to commercial products. And we also have the very significant commercial launch of Brensocatib, which I already mentioned. Excellent. Good. So, one of the things that emerged from 3Q was your decision to call your 2025 convertible debt. You also restructured the existing term loan that you have. Just your motivations in doing this at 3Q and how does that lowering of your debt to equity help influence your strategic decisions going forward? Yeah, the way people have characterized, I think, fairly our approach to our balance sheet up to the phase 3 data for brensocatib was that we were really taking a levered bet on the positive outcome there, with the benefit for our shareholders because by issuing convertible debt, obviously the amount of dilution is less than it would have been if we had issued straight equity. Our convertible debt got up to $800 million-$900 million. We retired the first portion of that, which was due in January of 2025. That's now done. We have another substantial amount of convertible debt, which is well in the money and will be eligible for calling in the middle of next year. We've already said publicly that that would probably be our likely path to follow. One never knows, et cetera. Certainly that will enable us to take that convertible debt, turn it into equity to the benefit of our shareholders because it would be less diluted than it would have been if we had issued equity at the time. Alongside that, we have a term loan, which we have just restructured to lower the interest rate. We've also added another $150 million to that term loan, which will come into the fourth quarter. We also accessed our ATM in the third quarter. The consequence of all of this is that we have a brand new balance sheet. We have $1.5 billion, roughly, in cash as of the end of the third quarter. That puts us in a very strong position to be able to affect all of the different programs I described across the four pillars, which we're very excited about. It's sort of a rare thing to have a company that has one commercial product that has launched successfully, the opportunity to expand the label in that product, then add a second and third product in close proximity that will represent very substantial revenue generation. We've said publicly the first pillar would get in excess of $1 billion in peak revenue. The second pillar will exceed $5 billion in peak revenue. The third pillar will exceed $2 billion in peak revenue. That's our current thought. Excellent. And one of the things that's been quite striking to me for a company your size, and you touched upon it here, is the size of the pipeline, the number of catalysts you've got on the horizon. You've been particularly successful in your R&D productivity. Can you talk about the approach that you have here and what metrics do you have in-house that guide your decision-making on what you push forward? This, like the commercial success at the company, is really a byproduct of the strength of the team we have. We have created a group of people and a culture that allows everyone to bring their best selves to work. I think the consequence of that is you get smart people in the room, you give them the freedom to do the analytics, and they're going to come forward with some ideas that are going to be pretty exciting. If we can build a consensus around that, then I think you probably tip yourself into the category of serious consideration for whatever the asset is. That's how we built the company. We started with Arikayce. It came from our labs. TPIP, the third pillar, also came from our labs. Both of those are important clinical improvements in our mind through reformulation of the underlying moieties. The consequence of that has been real impact on patients, as we've seen in our clinical trials. To complement that and to reach into the realm of sort of traditional biotechnology, we in-licensed the second pillar from a large pharmaceutical company at an early stage of development and took it down a path that we thought made sense. And I have to say that in-licensing effort was deliberate. It was done right after the Arikayce path was clear on its way to commercialization. And at the time, there was a lot of skepticism, "Why are you in-licensing this asset that big pharma is willing to get rid of?" We felt very good about it. The entire team had a consensus view that it could work. It turned out they were right in a big way. And so, I mention that because right now, those three assets, all of which have the same sort of characteristics and asymmetric return profile to them, are now complemented by our fourth pillar, which there's some skepticism around. Why are we investing in the fourth pillar? Why do we have these developmental programs going on? It's the same strategy we put behind Brensocatib that worked out so well. And I expect the fourth pillar to deliver in a similar kind of way when we begin to turn over clinical data cards from that in 2025 and 2026. But for now, the key characteristics for any program we bring in or develop in-house is that it has to be first or best in class, and it has to have a clear impact on the patient outcome. Great. Well, let's run down these pillars. Obviously, the most exciting one in the near term is brensocatib and bronchiectasis. Perhaps can you just outline this disease for the people in the room that don't know and perhaps summarize what we saw in the ASPEN data, including some recently published data with the subgroups? Yeah. So, what we have in our second pillar is what's called the DPP1 inhibitor, which acts to inactivate neutrophil serine proteases that are recruited from the bone marrow and the neutrophil into neutrophil-mediated diseases. In the case of bronchiectasis, the lung. The clinical community refers to the disease pathology of bronchiectasis as a vicious vortex, which is a complement of poor mucociliary clearance, inflammation, the arrival of infection, and the consequence of all of that is this experience called an exacerbation. Exacerbation, I like to sort of liken it to a heart attack for the lung. It does permanent damage to the lung, and it makes that process I just described even worse. So, all-cause mortality goes up. Patients have a debilitating experience. These exacerbations can last up to 30 days. They're very impactful on patients. And right now, there's nothing approved to treat bronchiectasis anywhere. So, our ability to bring forward the first drug that cleared phase III with very positive data is a very exciting development for this community. At the World Bronchiectasis Conference this year, shortly after we came out with our data, one of the KOLs stood up to the room of other physicians and said, "This is our Vertex moment," referring to the CFTR modulator class that was introduced to the treatment of cystic fibrosis. And feeling like the DPP1 inhibition pathway that we have unearthed is really going to have the similar kind of impact on bronchiectasis patients. So, this is a once-a-day pill, small molecule. And the data that we saw, we hit our primary endpoint with high statistical significance, which is a reduction in pulmonary exacerbations. We saw improvements in lung. We saw the preservation of lung function at a statistically significant level at 25 mg dose. We saw quality of life measures that were in favor of the treatment arms. We saw the delay in onset of the first exacerbation. We saw the higher probability of having no exacerbation. So, really, across the board, clinically, very compelling data, creating all this excitement around the class. But equally important is the safety. We saw comparability to placebo in terms of the profile of this drug and what it does to patients. So, you're looking at a low treatment burden, a very low level of friction for uptake. And that's consequently why we think this is so interesting, because you're talking about a million patients diagnosed at the time of launch between the U.S., Europe, and Japan for a product of that profile. These are pretty exciting times. Excellent. And I want to touch upon the KOL feedback that you've had so far. How has that been from the physician side? We've got statistical significance. Is this clinical significance? Yeah, it is very important that all the KOLs that you've heard speak at venues like the World Bronchiectasis Conference, the CHEST Conference, the European Respiratory Society meeting. At every one of these, you'll see the KOLs get up and talk about how clinically meaningful our data are and how excited they are. We've done some survey work in the aftermath of that and found that 80% of the respondents to the survey indicate that they intend to prescribe this drug for their patients. So, that's a pretty astonishing level of enthusiasm from the thought leadership community. You touched upon filing with FDA later this year, before year-end. Do we know that that's going to be a six-month review time yet? So, we have Breakthrough Therapy designation in the U.S., and we also have a PRIME designation in Europe. And so, for the U.S., that should afford us priority review. But we'll see what the FDA decides. This is a first-in-class, first-in-mechanism, first-in-disease product. So, we want to give them their due. But we are on track to meet those timelines and feel pretty good about where we are. Your discussions with FDA here, I'm aware you can't say everything on dose, but between the 10 and 20 mgs, how's that discussion progressed? Yeah. So, for everyone's edification, we did a 10 mg dose, a 25 mg dose, and a placebo dose in the ASPEN study. And some of our other studies were actually going up even higher than that 25 mg dose. There were some things about the 25 mg dose that looked a little more interesting. But I think the important message is both of them worked. Both of them are compelling for the treatment of patients. And so, we're going to include the data for both in our package to the FDA. And the result of that will be the FDA's evaluation that we will read off of. We'd be happy taking forward both of them or either one of them. I think 25 has some features that I think are a little more interesting, but let's see how it unfolds. Okay. Excellent. And then access. How have your access? Well, let's talk about pricing first. So, you've given a range in pricing. I think it was $40,000-$96,000. Perhaps can you talk about the pushes and pulls which get you towards either the bottom end or the top end of that range? Yeah. I mean, whenever we think about pricing in this sense, we always look at the impact of the product on the patient. And so, when we bookended those prices, it was to give people some sense of where we might end up. At the low end is a product that is like Fasenra, which is a specialty treatment for asthma, eosinophilic asthma, to be specific. And then, as you think about the upper end of that range, that's sort of like the idiopathic pulmonary fibrosis products. And so, anywhere in there, we are comfortable thinking that our product is as impactful, if not more so than those programs. We think that range is appropriate for a population of this size. And we obviously won't make any final decisions until we're right upon launch. But clearly, the market access work we've done has made it evident to us that this will be a medicine that is supported both in the Medicare and in the commercial setting. So, we're pretty excited about bringing it forward. The work to educate the market access community started about a year ago, and it continues in earnest now. So, that's something we're pretty excited about in terms of what we're hearing back. But I just would mention, of all the things that a company focuses on during a commercial launch these days, the single most important is market access. And so, for us to have a very positive experience with Arikayce, our first product, gives us a lot of insight. This product, all the feedback we've gotten is very strong. Okay. Excellent. And on those access discussions for Medicaid, you're going to use the Medicare exception pathway. You've got experience here with this with Arikayce. Perhaps can you talk about using this for 2025 when it comes out, potentially at mid-year? And do you think that could be the same for 2026? Yeah, so we'll see how it unfolds, but I would expect that we'll go through the medical exception process in both settings. That's fine. That's quite common as drugs get launched. Eventually, they will decide where they want to put us on formulary and what that looks like, depending on where we set price and how we set, if any, discount to facilitate some of that uptake and to create what I like to describe as a frictionless process for a patient to get access to medicine. Those are all forces that bear on how we think about actual list price from the WAC and so on and so forth and what we might do to work with some of the market access world to ensure a smooth uptake. As you say, we did this with Arikayce. We still do it with Arikayce six years into launch. It's been a very effective interaction, and I think our access for Arikayce is second to none. Okay. And then on the commercial side, is sampling going to be a strategy that you're going to use going forward? It's not something we're currently contemplating. We don't think it's going to be necessary. We think we can move forward without that. Okay. And then compliance in this population of patients. If you're taking this product, do patients feel a difference, do you think? And is that going to help the compliance for taking it? Yeah. You know, that's one of the most interesting things about the phase three data is that we saw very directionally significant improvements on Quality of Life-Bronchiectasis and other measures that were taken to understand whether patients feel better on the medicine, and the only reason it wasn't statistically significant is because it was a hierarchical analysis. We had it at the bottom, and there was something that did not clear above that. I can't remember what it was, but the p-value, nominally statistically significant, it was several zeros for both QOL-B and the other measure. That's very important because for patients that are feeling these exacerbations or flare-ups for their quality of life, which is so severely impacted, for them to say that they are clearly feeling better after treatment is noteworthy. It will help us tremendously with compliance and with interest in patients not only taking it, but continuing to do so. I can tell you an anecdote. We had a patient after phase II that showed up at the front door of the company and said, "I'm not leaving until I talk to the CEO because I want to remain on this medicine." This woman had been told to get her affairs in order, had been randomized during the phase II study, and had, as a consequence of going on the medicine, improved dramatically in her mind to the point where this was, for her, a life-altering medicine. Now, obviously, one patient is not necessarily indicative of everyone's experience. I put all those caveats out there. But I will also just mention, it's a rare thing to have a patient feel that compelled about a medicine they're taking. It was an early sign that we had something really special. Excellent. And turning to something you touched upon was your sales force. So, perhaps can you just give us an update on where we are with that for getting the launch ready and then how you're ensuring your team is ready for this successful launch? Yeah. Let me back up a minute, because one of the things that we have been thinking about for a long time is this launch and preparation for it. The team has had literally a Gantt chart down to the day for well over a year for what it's going to take to launch this medicine in a first-class way. We did the same thing for Arikayce. And just for history, people were thinking Arikayce would do about $40-$60 million in the first year of launch. We did about $133 million. And that was because of the same approach. So, we resourced on the assumption of success. We didn't get the data until May of this year. And at that point, a lot of people felt like the starting gun had gone off. For us, it had gone off about a year and a half earlier. As a consequence, on the market access front, on the medical education front, through the use of medical science liaisons, we've deployed into the field to educate about the disease and answer questions. Most recently, through the addition of therapeutic specialists. With Arikayce, where we're commercially launched in the U.S., Europe, and Japan, in the U.S., we had about 64 reps in the U.S. to cover all of Arikayce. Our strategy there was to cover both the centers of excellence and the community-level pulmonologists. We've added 120 additional sales reps to those 64. We now have 184 reps. That is sized so that we can call on every pulmonologist in the United States. We know where the pulmonologists are, and we know who's treating this disease because there is an ICD-10 code for it. This is a situation where we are resourcing for a strong launch. That's our intention. And with these people now trained and in the field as of October 1st, we're off and running both promoting Arikayce appropriately to appropriate patients who are refractory and as well, or rather to their physicians, and as well to educate about the bronchiectasis disease and build those relationships so that when the drug is approved, assuming that goes forward as expected, we'll be in a place to launch day one. What percentage of your bronchiectasis patients are treated at these large academic or specialist centers? It'd be hard to estimate because it depends who you include in and out, and that landscape is changing. Perhaps most important is that concept of the shifting landscape. Let me explain a little bit what I mean by that. The COPD Foundation has recently launched an initiative to certify roughly 150 new centers of excellence for the treatment of NTM and bronchiectasis across the United States. That process is well underway now. Those centers of excellence, like National Jewish, which are universally known as excellent pulmonology centers, and there are many others in the country, are about to be complemented by another 150-odd centers where folks won't have to travel to the more remote places to get treatment. And for something like Brensocatib or Arikayce, there will be places that have specific guidelines and training that they have to accomplish in order to be declared a center of excellence. And that will make them uniquely able to treat these patients. Okay. Understood, and we're all going to be watching this launch very intently. Is there going to be a way we can measure this, so could we just look on IQVIA? Could we track prescriptions through that? Or is this going to be a bit more unknown? Yeah. I'm not a huge fan of the script tracking. So, I don't know how we're going to handle that. I suspect we won't support that. But no final decision is made there yet. I think the reason for that is, look, it's really not about any week or month or even quarter. It's the trend and it's the strength of the effort behind the commercial launch. If the product is impactful on the patient and the physician understands the disease and has appropriate patients, the drug, in my opinion, should sell itself, and the therapeutic specialist is there to facilitate greater understanding and better success in the ultimate outcome for the patient. And in this way, they really have an important role to play that is clinical as well as promotional, in my mind, much more clinical than promotional. With this in mind, I would say that the metrics we're going to look for are best-in-class launches. So, what does that look like? What we've tried to say to folks is, if you look at the best launches that are out there, Dupixent, something like that at the high end, that really set the bar with quarters three through six getting to about $700 million in revenue. Not the low end, but at a lower bookend, you would expect maybe $400,000 or $500,000. So, anywhere in that $500,000 up range in quarters three through six, to me, would be a fantastically solid launch. In the first two quarters, you would see best launches getting to perhaps double-digit millions when you combine the first and second quarter. So, the upper double-digit million sort of range. We're not giving guidance yet at this point. But if you look at those benchmarks, that's what you'll find. Quarter one and two getting you to sort of the upper end of double digits when combined, and then quarters three through six getting somewhere between $400,000 or $500,000 and on the extreme end, on the upper upside, $700,000. So, that's how we think about what excellence looks like. And certainly, that's what we are shooting for. Understood. If I look at Visible Alpha Consensus for 2025, you'll be on the market, we hope, for two quarters. That's at $98 million. That seems on the lower side versus your expectation. Well, if it's the first two quarters, that would be at the very, very upper end, right, adding those two together. I would say I'm not going to comment on whether I think they're on or not. We won't know, frankly, a lot more until we've set price and we've gotten our final marketing work done right before launch. What I can say is that this drug, the physicians want to prescribe it. The clinical data is out. It's been understood. It's really unequivocal in terms of being effective and safe. And when I say effective, it's across a range of measures. So, this is a very exciting development. And I think it's very important at this point to just pivot a little bit and mention that we are talking about DPP1, not Dupixent, DPP1 for bronchiectasis. But what it really does is it impacts neutrophil-mediated diseases. Behind bronchiectasis, we already have a phase II trial running in CRS without nasal polyps. We have another phase II trial that's about to kick off in Hidradenitis suppurativa or HS. That trial will kick off by the end of this year and is on track. We think about DPP1 as making its first impact in bronchiectasis. We've said that that alone would get us to north of $5 billion in revenue, peak sales. We think about CRS without nasal polyps, which will read out in the second half of next year. If that data is positive, that's another patient population that numbers in the hundreds of thousands or even low-digit millions. It is a population every bit as big and exciting as bronchiectasis. That means that this drug is really on its way. Assuming all those data are good and regulatory approvals fall in line, this is a blockbuster, and that's why I would keep an eye on it. Excellent. Well, let's pivot to the next pillar of growth, TPIP, PH-ILD. We're going to see some data presented at Rio. Are you going to Rio? No, look, I don't get to go to Rio de Janeiro. But there will be data there, and the team will be there, more importantly. They're the ones that actually know this drug inside and out. What I can tell you overall, and you saw this when we put out the top-line results in May of this year, is that these data are very compelling. It's a small study, just under 40 patients, randomized three to one using our drug versus placebo. But the outcomes were really quite striking. You saw a six-minute walk improvement. You saw time to clinical worsening benefit. There's just a lot in this data set to like. And it suggests that we may have on our hands really a best-in-class therapy, prostanoid, for the treatment of PH-ILD. And hopefully, if the data in PAH, when it comes out next year, is good, a superior treatment for PAH as well. Excellent. And have you discussed phase three with FDA yet? How are we thinking about those? We haven't commented on that other than to say that we are in the process of getting ready for PH-ILD phase three. That would be toward the end of next year. In the interim time frame, we're going to be optimizing the actual manufacturing to ensure that we can have the highest dose in one capsule. One of the things that's important to understand here is this would be a treatment administered with a single capsule. You would breathe it in, dry powder inhaler, very convenient. You're breathing in an inactive drug in contrast to the others that are on the market. And importantly, the amount of drug you're able to breathe in is far greater as a result of the way this is designed. So, to be very specific, when you're building these trials, you go up to max tolerated dose, in our case, 640 micrograms, which is much, much more than you can get after a full day of administration of something like a Tyvazo. So, this is a big deal for patients who have this condition. It would be a once-a-day with 24 hours of coverage, getting up to doses far in excess of what's available and possible now. Excellent. And similar to Brensocatib, can you summarize your other indications for TPIP? So, we've got PAH, PH-ILD, we've got IPF. Yeah. So, IPF is another interesting indication. That's one that UT is going after at the moment with Tyvazo. We'll see what that data looks like. I am on the skeptical side that that's really going to have an impact on this fibrotic process in these patients. But we'll see. And if there is good data there, then we'll go after it. We want to be prudent with the deployment of capital. So, that one, we'll wait to see what they do and then be a fast follower if it looks like it is effective. But I am very excited about PAH and PH-ILD. And those are very substantial populations, as people are well aware from the success of other drugs. I'll remind everyone that Sotatercept, after its phase II data was taken out for just over $11 billion by Merck, widely considered to be a smart acquisition. When you look at that, that was based on their ability to reduce pulmonary vascular resistance, among other measures, roughly 34%. Most prostanoids are in the low 20s in terms of their PVR reduction. I can tell you on the blended blinded data basis, we have, including all patients, both those on placebo and treatment, we're already in the low 20s. So, if you remove the placebo patients and assume there's treatment effect in the treated population, we're trending toward what could be a very exciting data set next year that could look interestingly competitive to sotatercept. I can also share that we have individual patients that have seen PVR reductions well in excess of 65%. PVR does not go down spontaneously in these patient populations. So, that is a remarkable change. And one might imagine a day when TPIP and Sotatercept could be used together to treat these patients and get them back to a state of basically normalcy. So, big changes coming in the PAH, PH-ILD market. And we're going to be right there with what we think will be a first, pardon me, a best-in-class therapy. The phase two data next year, is there any other update on timelines we should? No, just that it's next year. So, second half of next year is, I think, what we said. Okay. Arikayce? Arikayce. We ought to talk about that. ENCORE, first line. Yes. How's that progressing? Data in 1 Q 2026, I think you said. Yep. Is there going to be any interim looks before that? So, there won't be any interim looks. What we know is that based on ARISE, which was the sister trial to this one, which is called ENCORE, ARISE worked. It showed 80% of patients were culture converted within the first six months, which is a shockingly high percentage. And what that also means is that physicians are going to be very inclined to treat these patients earlier with these data, better to treat them and culture convert them than to wait until they become refractory to treatment. And probability of success gets much, much lower at that point, as we know from the data we've generated. So, we're very excited about the ENCORE data proving out what was seen in ARISE. That will be, as you say, first quarter of 2026. And that continues to be our target. I feel very good about that. We're fully enrolled in that trial. I think what's important for people to understand is our revenue estimate for this year is $340-$360 million, which we just reiterated on our third quarter. The addressable market, if we were to be able to secure using ENCORE frontline approval, that would go up about five to seven-fold. That is a very substantial increase. Again, no competition in that space now. A pretty exciting base case from which to build the value in this company. Excellent. And the last one on Arikayce is we do have Part D reform coming in next year, January the 1st. Any impact on Arikayce from that? Yeah. So, I think when people think of the Inflation Reduction Act, one of the most important aspects of that is the Medicare Part D impact. And that is that they cap the out-of-pocket spend for all patients at $2,000 starting in the first quarter of 2025. That applies to all drugs that could benefit from that, including Arikayce, which it certainly will, but also Brensocatib. So, if you think about these two drugs, a patient might be taking both of them, and their out-of-pocket would still be capped out at $2,000. In the case of Brensocatib, we will be included in being responsible for a portion of that catastrophic amount, the 20%. But we still feel extremely good about the profile of this drug, what it can do, and the ease of burden that gives to patients to get the medicines that they need. In the end, that's what this is all about. Sure, and your pricing will obviously take that into account because you're going to be paying this portion within catastrophic coverage. Exactly. Okay. We're approaching the last few minutes here. Thank you very much for your time. We obviously want to have you here again next year. One of the things I'm doing for the companies that I'm hosting is asking them this time next year, what are the three things that you hope to have achieved with Insmed? And then I'm going to put you on the hook for those three things this time next year. I love those kinds of challenges. So, I will tell you straight out of the gate, the first and most important thing we need is an effective launch of Brensocatib in the treatment of bronchiectasis. And I feel highly confident we'll be able to deliver that. The second thing I would tell you we want to focus on is advancing all of the clinical trials that we've been describing here. There's close to half a dozen. They may not all read out by this time next year, but some of them will have. And I want that data to be as compelling as the data we've seen from Aspen, from the PH-ILD study, because that sets us up for still further opportunities of commercialization that are going to be quite compelling. And I think the final thing I would say is I want the company to continue to advance in terms of its development in a focused way. So, we're in the U.S., Europe, and Japan. We do not have ambition to build out beyond that in dramatic ways. We may use distributor relationships or what have you. But we're not going to build an empire. We know we can commercialize in those territories. We're going to stay focused there. The next hurdle in this third goal is to ensure we do that by bringing forward compelling medicines that we can commercialize. Excellent. Well, there's no more questions on the iPad. So, thank you very much, will Lewis. Thank you. We'll talk to you later. Look forward to it. Thank you. Bye-bye. Bye-bye.