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Goldman Sachs 45th Annual Global Healthcare Conference

Jun 10, 2024

William Lewis
CEO, Insmed

PH-ILD, which came out just prior to the ASPEN data, and then, of course, the ASPEN data itself, which was better than we expected. So the combination of all three of those things and our recent commercial day for just the indications we've talked about, we have said would drive peak sales in excess of $8 billion. Now, for a company that is sitting today with a forecast of $340 million-$360 million , that's obviously a sea change, but it is really one of the reasons why I think we're just at the beginning of our next growth cycle.

Speaker 2

Maybe before we get into your individual programs, you know that comment you just made about $340 million-$360 million is your revenue guide this year. You're talking about $8 billion in the future. What is your level of confidence that Insmed and the infrastructure you've built is capable of supporting that?

William Lewis
CEO, Insmed

Yeah, I mean, my short answer is my confidence is extremely high. The reason for that is not only have we done successful commercialization as a first-in-disease effort previously, but the call point here is the same. So when we talk about the majority of that revenue generation, it's coming from ARIKAYCE, going into a frontline indication. So the drug has been on the market for six years in the U.S. It's been on the market for several years in Europe and Japan. It's been very successful, continues to have double-digit growth at the moment. That's prior to its expansion into all MAC NTM patients. That would, again, be another first-in-disease indication. So that infrastructure is built. We know we've been successful there. We will then bring forward brensocatib and bronchiectasis. Bronchiectasis is the exact same call point.

So we're going up in patient numbers dramatically, but the infrastructure is the one that is already in place. So we're augmenting that. We're adding more people. But in many ways, the starting gun went off for Wall Street or some on Wall Street when the data came out. For us, it went off several years ago. We've been preparing for this moment for a long time on the assumption of success. And while it's been measured, we have had our expenditures that people observed have been very substantial. And that's because we've been getting ready for this blockbuster launch.

Speaker 2

Maybe let's jump to brensocatib. Obviously, the ASPEN data read had been a huge focus for investors prior to the data, now continues to be as they think about the forward path for Insmed. From the ASPEN data set, what surprised you most from those results, whether it's the primary, the secondary, pulmonary exacerbations, quality of life, lung function?

William Lewis
CEO, Insmed

Yeah, I think there were two things that really stood out to us. The first is seeing that statistically significant impact in slowing the rate of lung function decline. That was very unexpected, and it was very significant because that allows the physician to say to the patient, this will not only prevent you from having further damage, permanent damage from exacerbations, but it can actually improve or slow the rate of decline of lung function, which is common for these patients. So that's a big statement. And like I said, one we weren't expecting. I think the other thing that we weren't expecting is such a clean safety profile. To remind everybody, this study was one year in duration, and we saw comparability to placebo in terms of side effects, including side effects of special interest.

So for a chronic medicine to have a profile that is comparable to placebo with functional improvements like I just described and having such statistical significance on the primary endpoint, it really doesn't get a lot better than that. What we've heard from physicians is nothing short of just a celebration of these data. I think when we go to World Bronchiectasis in early July and share more when we are doing that at ERS in Austria in September, there's just going to continue to be a lot of examination of this and a real celebration of what this is going to mean for patients. Of course, for us, it's just the beginning. We are also with a trial already underway in CRS without nasal polyps.

When you have this kind of impact on a disease state that is this evident and with a drug this safe, it really unlocks the value of this so-called pipeline in a product. And that's what this moment is all about. That's why we invest in biotech for moments like this, where you unlock a complete mechanism that gives you access to potentially impacting diseases in a number of different places. So as big as bronchiectasis is, at 1 million patients in all the areas where we have commercial infrastructure, CRS without nasal polyps is another indication that has nothing approved to treat it. And the incidence rate is 400,000 patients a year. The prevalence is in the tens of millions, but we're talking about the incidence rate alone at the severe end of the spectrum.

As exciting as this development is for us and as much value as it has ascribed to the company in a short period of time, it really is just the beginning as these other opportunities come to fruition.

Speaker 2

How meaningful is 20% reduction in pulmonary exacerbations?

William Lewis
CEO, Insmed

It's extremely meaningful. It was statistically highly significant, but also clinically, as you heard from James Chalmers, who's a thought leader in the field on our data review call, he described it as a highly clinically meaningful reduction. You also have to remember that these patients have two or more exacerbations coming into the study. And this is a nonlinear variable, so it can move up and down. That's why seeing statistical significance and a 20% reduction in both doses was so exciting to the community. Equally important is within the secondary variables, you saw a meaningful improvement in the probability that they would go a year without having a single exacerbation. And that was also statistically significant, 40% improvement in the probability of not having an exacerbation at all.

So you look at the data from many different angles, and you come away with the belief that you're going to slow the patient's experience of having exacerbations, which do permanent damage to the lung. You're going to slow the rate of decline of lung function. You're going to increase the probability that they go a year without having any exacerbations. And you've got a nominally statistically significant improvement on quality of life benefit. The patients feel better, and the side effect profile matches placebo. It just doesn't get any better.

Speaker 2

Maybe in that context, as you think about the totality of brensocatib's profile here that you've seen, is it fair to assume or maybe speculate that 25 mg will be the dose moving forward, given the benefit on lung function and quality of life?

William Lewis
CEO, Insmed

The short answer is we haven't made that decision yet. We want to continue to complete our analysis of the more detailed data to see if there's any sort of concept of trade-off contained between the 10 mg and 25 mg dose. There are other strategic reasons why we might want to bring forward two doses. It's clear that the 25 mg dose with the safety profile comparable to placebo and those benefits I talked about on QOL-B and FEV1 decline really stood out to the physicians we've spoken to, and they're very excited about that.

Speaker 2

Now, on your commercial day, one new update was your thinking around potential pricing. We've always talked about Fasenra-like pricing as a floor at $40,000, but now you've kind of provided an upper range. Help us think through maybe the work that you've done that gives you the confidence that that range is sustainable here?

William Lewis
CEO, Insmed

Look, I think the reality was prior to the ASPEN data, people had a very difficult time building financial models that could conceptualize the enormity of the opportunity of this drug. We've said that this is now a $5 billion, in excess of $5 billion in peak sales drug just for the bronchiectasis indication alone. We are very comfortable with that estimate. I can tell you that is driven off of a penetration rate that is not aggressive and a price point that sits comfortably within that range we just described. And that would be the price that we would carry forward into the subsequent indications we're targeting, which are not contemplated in that $5 billion peak sales number. There's a long way for this drug to run, assuming that it continues to perform the way it has to date.

And so I think this moment where people reflect on, well, how high could the price be and how big could the market be and so on and so forth will really begin to unlock the value here. So I feel very comfortable with that price point range that we've given. We've done a lot of price work already. We'll do more right before we launch, which will be in the middle of next year. And I would tell you that the market access work we've already done, the medical education work we've already done, the groundwork here has been laid for several years, and we are in a very strong position to have a very good launch.

Speaker 2

When you think about the 500,000 approximate patients that are currently diagnosed with bronchiectasis, that's with primary bronchiectasis, and you've also talked about potentially expanding even beyond that within the bronchiectasis population, how do you meaningfully grow that population? How do you access them? How do you diagnose them to bring them onto treatment?

William Lewis
CEO, Insmed

Well, that work is actually already underway. If you look at what is going on in the community and you saw this even at the American Thoracic Society, there's a lot of dialogue about misdiagnosis of COPD or patients who have COPD who probably also have bronchiectasis. This population of the 20 million patients in the U.S. that have COPD, it's thought that somewhere in the 20%-30% range probably also have bronchiectasis. They haven't been diagnosed as such because there's nothing to treat them. So the arrival of brensocatib, assuming that it is approved, would be the catalyst for that diagnosis. So when we talk about the 500,000 patients in the U.S., those are patients who are already diagnosed with the J- code today with bronchiectasis. They're probably the more symptomatic patient. That's why they've been diagnosed as such.

But we think there are many more in the COPD or asthma populations that are probably also bronchiectatic. They're either misdiagnosed or not yet diagnosed. The definitive diagnosis of bronchiectasis is accomplished with a CT scan. In contrast, in COPD, it's a spirometry. So it's a simple test to give the patient to be able to diagnose the bronchiectasis, but it hasn't been underway because there's nothing to give on the other end of that rainbow. Now we change that dynamic with the arrival of our drug, assuming it's approved, and put ourselves in a very enviable position to be able to help those patients.

Speaker 2

What is the understanding that for those COPD or asthma patients who are also bronchiectatic, what is the understanding that that is actually neutrophil-driven since there are 30% of patients that it's eosinophilic-driven?

William Lewis
CEO, Insmed

Yeah, I think what we've seen so far from physicians that we've spoken to and we've been hearing in the dialogue is if the patients are on max dose LABA/LAMAs or what have you in terms of the profile of treatment they're getting for their condition and they're still experiencing exacerbations, then it's a simple CT scan and a visit to the pulmonologist to be able to give a definitive diagnosis of bronchiectasis. And we know we didn't separate from eosinophilic, non-eosinophilic patients in our ASPEN study. So this is a neutrophil-mediated disease. If they're experiencing that profile, they probably are going to be eligible and will benefit from the drug. And that's really what we're excited to explore.

Speaker 2

As you think forward, you mentioned potential approval, hopeful approval in 2025 next year. Speak to your launch preparation plans now. What is picked up on the back of the ASPEN data? What still needs to be done? And remind us on the incremental add to your infrastructure to support this launch.

William Lewis
CEO, Insmed

Yeah, so we today have about 60 or 70 therapeutic specialists in the US to cover the ARIKAYCE refractory population. That was designed to be a little bit broader than would otherwise be necessary if we treated it like an ultra-orphan drug. Even though we were targeting 12,000-15,000 patients, we wanted a call point that included the community-level physician, both for frontline ARIKAYCE contemplation and brensocatib in bronchiectasis. So we will add roughly another 180 therapeutic specialists and the leadership above them. So we'll have just north of 200 folks that are ready to help. That hiring has kicked off in earnest in the aftermath of ASPEN. The leadership was already in place prior to, and we invested a lot prior to in things like medical education, market access, the leadership around those functions, building out that calling capability to educate about disease state.

The therapeutic specialists will now be brought on board. Many have observed that we have 110 job postings that just went up on LinkedIn. The volume that we're getting for those is overwhelming. I would just say that we kick off now with that last mile of infrastructure needed to supplement what was done last year. I think collectively, given that that is going to benefit not only the bronchiectasis launch, but also ARIKAYCE in refractory and ARIKAYCE going into frontline, there's a lot of synergy we're getting from this investment. That is going to inherently benefit to both of those franchises.

Speaker 2

So you've mentioned the $5 billion in peak sales, but maybe talk about the cadence that you would expect given the feedback you've heard from physicians based off of the totality of the data that you've seen. How should we think about the pace of adoption and what the early, mid, and longer-term launch could look like?

William Lewis
CEO, Insmed

Yeah, I think this will be a rapid adoption. We'll know more when we get closer. I don't want to overcommit at this point, but I can just tell you the enthusiasm we're getting from physicians and their indications of how quickly they'll write this script for their patients has been very positive. In addition, we've done a lot of preparation work for that moment when we do launch. And I think people ask, well, what does your market access work look like? We've done two separate pricing studies and uptake studies with two separate firms, and both came back with comps of Humira and Dupixent to be thinking about in terms of launch trajectory. Now, those are incredibly successful programs. We're not making that statement today, but I would say that the arrows are pointing in that direction for a very strong launch.

And of course, probably the most important driver of that is the safety profile of the drug. That is usually the biggest impediment to rapid uptake. And the fact that this is as clean as it is really should lay the groundwork for a rapid uptake.

Speaker 2

As you think about potential expansion, obviously you have a lot right here with bronchiectasis, but you've talked about potential expansion, as you mentioned, to CRS without nasal polyps. HS, what other indications would make sense here?

William Lewis
CEO, Insmed

So we started several years ago after the phase II data got published in the New England Journal in our chemistry labs building subsequent DPP-1s. So one of the things we're conscious of is IRA and the impact that that could have on this development path. But also, this is a small molecule. So our intellectual property composition of matter goes to 2035. Hatch-Waxman should get us to 2039. That's a very good runway for a small molecule, but it will eventually come to its end. What we have in our labs are DPP-1 successors, so 2.0, 3.0, call it. And those we intend to bring forward. We'll look at other indications like rheumatoid arthritis, lupus nephritis. And we'll leave brensocatib to focus on bronchiectasis, CRS without nasal polyps, and hidradenitis suppurativa.

Speaker 2

I guess maybe what is your level of confidence that the read-through that you see from the ASPEN study with brensocatib and bronchiectasis to these other indications?

William Lewis
CEO, Insmed

So very importantly, one of the most encouraging readouts from ASPEN was the 25 mg Quality of Life-Bronchiectasis questionnaire score. That was nominally statistically significant. In the hierarchy, it wasn't stat-sig because something above it had failed. But the p-value there was like less than 0.0004 or something like that. It was very, very low. So there's something going on there, symptomatic benefit for patients who were taking the drug. That is what we heard anecdotally during the trial that the physicians thought they knew who was on drug and who was not. And that is very important to be able to see that this mechanism of action can create a symptomatic benefit because that is what we're measuring in CRS without nasal polyps. It is a symptom score.

As we've shared so far, of the 50 patients that are in the study, taking a look at the blended blinded data, you're already seeing patients respond with improvement in those symptom scores. So it's an early read. It's a small number read. But given the symptomatic benefit seen in ASPEN, we find it to be very compelling. That raises the possibility that we could be successful in CRS without nasal polyps, which, as I say, is not included in any of those forecast revenue numbers and is as big as bronchiectasis, if not bigger.

Speaker 2

We'll jump to an audience question.

Two questions.

William Lewis
CEO, Insmed

You got it. Yeah, there you go.

Speaker 2

Two questions. First, you acquired this drug from AstraZeneca, and they want to negotiate with you for asthma COPD. Bronchiectasis is one of the symptoms in asthma COPD. So that's your indication. That's your $5 billion drug. If they come in on asthma COPD, how do we make sure you get paid for bronchiectasis versus how's the terms of that deal going to be structured? And second, DPP-1 successors, 2.0, 3.0, are they yours or did you get them from AstraZeneca as well?

William Lewis
CEO, Insmed

Yeah. So the successor DPP-1 molecules are ours. They're not covered by the agreement. And the AstraZeneca option is their right to ask to negotiate commercial terms to take the drug into COPD or asthma. We will negotiate in good faith in a time-limited way around that. And then at the conclusion of that time, they can put forward an offer. But it's our right to accept or reject that. If we reject it, then nobody develops in COPD or asthma. In my mind, as I've shared with them, it's hard for me to understand with all humility what they really bring to the table at this moment for COPD and asthma. If they were to go off and develop there, they'd have to do twin phase III studies in each of those indications for a small molecule, the time-limited IP expiration.

And then what do they have on the other end of that rainbow, assuming it's successful? They have the ability to treat patients who are a subset of those populations. They would be step-edited in terms of what they would get paid and how the patients would gain access to the medication. And very likely what they're really treating are patients who probably have bronchiectasis. So the easier way for us to capture that value is to simply get those patients diagnosed as bronchiectatic and then they're on label for the ASPEN study we've just completed. No additional work would be required. So if you have COPD or asthma and you are showing exacerbations and you're on max dose therapy for those indications and you go get a CT scan, lo and behold, you have bronchiectasis, you're on label for our drug right now. Yeah. Yeah.

We have to enter this in good faith. That's part of this arrangement, which we will do. But I have been very vocal, and I think correctly so, the intrinsic value of this asset far exceeds the value of the company even at its current trading value.

Speaker 2

Great. Well, maybe we can jump to TPIP, which I think you've laid out thoughts that this could also be a $2 billion+ peak sales opportunity. Help us understand what underpins your confidence there. You've had some recent data. Walk us through that and why you're so excited about this asset.

William Lewis
CEO, Insmed

So TPIP is treprostinil palmitil inhalation powder. It is actually treprostinil with a 16-carbon chain appended to it by an ester bond. It's in dry powder form, and the patient then is breathing in inert molecules. So one of the problems with treprostinil is it has a side effect profile if you breathe it in. Patients cough. They have other side effects. So this delivery allows us to get treprostinil in inert form into the patient's lung in far greater quantity than what is possible today. When I say far greater, I mean at the max tolerated dose of our phase II program, we are 60%+ greater in quantity over a 24-hour period than what Tyvaso or other inhaled treprostinil can accomplish. Once it's in the body, the ester bond is cleaved by esterases in the lung, and you effectively get a slow-release treprostinil in the local environment.

That has, as we've seen in the PH-ILD study, and I'm sure we will see in the PAH study, very significant benefit to the patients who are taking the drug, which should not be surprising. This is a known molecule, a known moiety with a dose-response curve. All we're effectively doing is lowering the peak and extending the trough of that PKPD profile. And that increases the area under the curve that the patient gets the benefit from. And we've seen that in the PH-ILD study. We saw a nominally statistically significant improvement in the time to clinical worsening, which for these sick patients was remarkable. It was a 39-patient study. So to see that kind of performance and to see directionally things going the right way on 6-minute walk test, that tells us everything we need to know, which is that greater quantities of this drug should benefit patients.

They appear to be doing so, and it's giving these patients 24 hours of coverage. So you get easier administration, 24 hours of coverage, and hopefully superior clinical results in both PAH and PH-ILD. Now, the data still needs to come out to validate all of that, but so far, so good. And it really shouldn't be a surprise because of the actual underlying molecule we're working with here, which is well understood. So when you think about all of that, it sets us up for a best-in-class prostacyclin in a market that we all expect is going to be dominated by sotatercept, but it's going to be a combination market. So sotatercept will be used, and a prostacyclin may also be used. And if it is, ours is going to be the one of choice.

We think we will be best in class in this disease state, and we think that gets us comfortably to $2 billion + in peak sales without a lot of risk between here and there.

Speaker 2

When you think about that blinded-blended data that you had for your PAH patients, what do you think that could imply on the profile that you're seeing emerge for TPIP? And when you think about that world that you've just spoken about, that you think that it'll be a combination play, is there a scenario where TPIP could actually be superior to sotatercept and be used preferentially?

William Lewis
CEO, Insmed

So here's where I get excited about this asset as being underappreciated. Sotatercept was bought after its phase II data for $11.5 billion, I think, give or take a billion. That was largely based on the profile of the drug and the fact that it was a novel mechanism, and it was showing a PVR reduction of around 33%-34% at its best level. On the blended blinded data we've seen, and we have to be cautious about this because of that, but it's not typical that you see patients have spontaneous pulmonary vascular resistance reductions. So if they are seeing significant reductions, it's not unreasonable to attribute that to drug. When we look at the responder analysis, we are seeing very attractive levels of PVR reduction, including some individual patients who are up in the 60+% PVR reduction levels. That is really exciting stuff.

If we see that in the PAH phase II data at the end next year when we put that data out, that will not be the end of this story because that's at 640 micrograms. The key opinion leaders for this study have now asked us to double again the max dose that we are taking these patients to based on the safety profile. So at our 640 dose, they're already 60+% greater than what you get with Tyvaso. You go to 1280, and it's pretty exciting to think about what that might do. So in the world where you think about sotatercept, could we unblind PAH phase II data next year and have PVR reduction that is equivalent to sotatercept? Yep. Could it be a little bit better? It might. We'll see.

But it will certainly, in our expectations, and we always do this with our data, I want to tell you right now, I expect it to be the best in class in prostacyclins in terms of PVR reduction. Six-minute walk is a little bit more variable just because it's such a variable measure. But PVR, I feel really good about. And I'm anxious to see what that data looks like.

Speaker 2

Great. Well, let's turn to ARIKAYCE, which has historically always been where we've started the conversation. Now it has taken a bit of a backseat to your pipeline here. But remind us where you stand in terms of development and the regulatory discussions you're having in advancing this into the frontline setting.

William Lewis
CEO, Insmed

Yeah. So again, when I think about what is most attractive about this company and where we sit today with the validation of these data sets that we've just been talking about, we started with ARIKAYCE in refractory MAC lung disease, and that was a first-in-disease drug. It's strongly recommended for use in the international guidelines. It's logical to take that drug into the broader population. The data we saw last fall showed that we could culture convert patients, 80% of them, within six months. Compare that to refractory patient population where you get about 1/3 , a little bit less than 1/3 converted after six months. So if you're a treating physician, what that data tells you is you don't want to wait. You want to treat these patients upfront with this drug as aggressively as you can.

So it's laying the groundwork for the uptake of this drug in the frontline setting. The frontline setting is comfortably over 100,000 patients in the U.S. Compare that to the refractory setting, which is 12,000-15,000 patients. Note that with just the refractory setting, we're estimating $340 million-$360 million in revenue in year six. So there's quite a bit of space here and a meaningful patient population we can benefit if we secure that approval. How do we get there? The ARISE data laid the first step on that journey. The next one will be when the ENCORE data comes out. That will be next year, and that will empower us to go after the patient population. The ENCORE data, just to remind everybody, is simply a longer version of the ARISE data. Patients were recruited with the same profile at the same time.

So ARISE was a canary in the coal mine. It was almost like unblinding the ENCORE data early and seeing how it performed. And it performed extremely well. So with all that said, we're in a very strong position. We will be talking to the FDA at the end of this month in a meeting about the patient-reported outcome measure we're using to secure their agreement with that for the primary endpoint of the ENCORE study. Once that is done, we will approach the FDA and ask them whether they believe that it is appropriate to file under Subpart H for accelerated approval on the basis of the ARISE data. While we think that is a proverbial long shot, it's absolutely a reasonable question to ask. And we'll report on the update of that once we've had that discussion. But we first need to get the PRO done.

Once they're at the end of this month, we'll have a meeting. Within a couple of months of that, I would think we'd be able to clarify everything that's going on with ENCORE.

Speaker 2

That $1 billion in peak sales, assuming in terms of the breakdown between refractory and now.

William Lewis
CEO, Insmed

So the two biggest markets for ARIKAYCE are the U.S. and Japan. There's about 145,000 patients in the U.S. Compare that with the refractory levels. In Japan, it's around 15,000-17,000 patients, and the U.S., 12,000-15,000 refractory patients. So these are very substantial increases in populations where we have our commercial infrastructure and calling effort already in place. Our assumption is that we would be taken up rapidly in both locations. And as we think about the ability to connect those patients, there was recently an announcement by the COPD Foundation that they're going to be establishing 100 centers across the United States focused on best-in-class care for bronchiectasis and NTM, those two together. It speaks to the medical community's mental picture of the important overlap of these two indications.

So the fact that those centers of excellence are going to be out there should facilitate better education, better patient treatment. These centers will get qualified. And the two drugs that are going to be available, if everything goes as expected for each of these centers, are going to be ARIKAYCE and brensocatib. It couldn't be a more perfect picture for us to be able to go in and make a real difference in these patients' lives by aligning with the medical community. So I expect it'll go smoothly. We're almost there. But this sort of highlights the next chapter of Insmed. We have brensocatib and bronchiectasis, but we're going to have CRS without nasal polyps next year. We're going to kick off HS at the end of this year. We're going to have ENCORE data next year. We're going to have PAH phase II data next year.

There's a lot coming as we get ready for the launch of brensocatib and bronchiectasis that's going to continue to make this interesting. I'll just make one quick mention because we're past the ASPEN data. Pillar Four is going to start to pull its weight. We've set as an objective for Pillar Four 1-2 INDs a year. We're going to start to hit that target this year. We'll have 1 IND this year. We expect to have at least 2 next year and 2 the year after. It's my expectation that those will be very impactful medicines, but the cost burden of those will hit as we are ramping up on bronchiectasis. I want everyone in the room to understand and listen that we have as a compass point profitability in our mind.

We're not pushing for that to be as fast as possible, but it is not out of the realm of our consideration now. We are angling toward that as an important strategic objective in the coming years.

Speaker 2

I guess maybe given everything you have going on with your late-stage portfolio, why this continued commitment to Pillar Four, and how do you decide which programs to bring forward?

William Lewis
CEO, Insmed

So we look at this the same way we looked at brensocatib. When we were getting ready to launch ARIKAYCE, we had this idea that we're going to go out and in-license a phase II ready asset for MAC presentation. At the time, the board had some hesitation about the wisdom of that, concentrate on ARIKAYCE MAC launch correct. Our belief, and they supported it, was that you want to have this asset ready to go obviously in the time between when you bring it on board and when it finally realizes value. And so we've seen ARIKAYCE come on board, and it reached its value for refractory. We're going to do the same thing in frontline. Brensocatib obviously was a success in bronchiectasis, but CRS was also underway before we knew the answer to the ASPEN study.

These acquisitions that we did with these different platforms that will bring forward the next generation of medicines to Insmed are going to be highly impactful, best in or first-in-class drugs for some of the most intractable diseases out there. I think we're pretty good at picking winning drugs and at executing clinical trials to bring about the value realization there by patient impact. And so every one of these that's coming out of Pillar Four had better be best or first-in-class.

Speaker 2

Remind us again, when will data start to emerge from these programs?

William Lewis
CEO, Insmed

Next year. You can look forward to data next year.

Speaker 2

Then maybe finally on the path to profitability that you've talked about here, what does that path look like? What does it assume in terms of which programs you will be still developing, commercializing, your OpEx spend?

William Lewis
CEO, Insmed

Yeah. I mean, right now, we've been observed as a company that spends a lot of money. We like to think that we're a company that invests a lot of money. We've been investing a lot of money, and it's so far so good. Our first three programs have all been winners. We hope that continues. We think the subsequent programs we're going to be pursuing are going to be winners. We are looking at the puts and takes in a very different way today than we have been in the past. We want to make sure that we're not constantly returning to the markets to say we need capital to pursue all these different ideas.

We want there to be a balance between the ideas we're pursuing, their proof of success, which will begin next year in dramatic form with bronchiectasis launch, but also an answer to what's next. Because if you end up just supporting a program or two, then history is pretty clear that you'll stall out as a company. We don't want to wait until we have to do an acquisition to build revenue for the future because when that's happened in the past, most of the precedents don't end up working. They spend a lot of money on a big acquisition, and it ends up being overpaid for something that doesn't perform. By building it internally over the last several years, we think we can bring forward best-in-class drugs at a very reasonable amount of money and still achieve our path to profitability.

Speaker 2

Maybe on the back of the recent financing round that closed, just remind us what is the pro forma cash runway here and the activities that that's designed to support?

William Lewis
CEO, Insmed

So we have a reinvented balance sheet is the way I would describe it. We were a levered bet going into ASPEN. We had $800 million of convertible debt, all of which is deeply in the money right now. So that converts into equity. The reason we did that was to be less dilutive to our shareholders. And I think it's probably fairly rare in biotech that it actually worked, but it did. And so that's a benefit that we like to celebrate. In addition, we had $600 million as of our last reported cash position, and we've just added gross proceeds of $750 million through this. So we not only augmented our balance sheet, but we also reduced our debt exposure pretty dramatically. So we're sort of reborn as a company with a very strong financial position and an awful lot to invest in.

Speaker 2

Maybe in the last minute, Will, any last remarks you'd like to share with us?

William Lewis
CEO, Insmed

I'd just like to say that I think we are really just at the beginning as we unlock what DPP-1 can do. This is a really important moment for, I think, investors who haven't been familiar with the story to take note of. Bronchiectasis is a massive market opportunity without competition. We are a first-in-disease drug. If you look at where we're going next, CRS without nasal polyps, again, no competition, first-in-disease drug. A small molecule once-a-day pill like this comes along very, very rarely where it unlocks a franchise and happens to sit in a crown with a couple of other jewels that are already working. So it's rare to be three for three, but that's where we sit today with the resources to pursue that and to grow the value. So very happy about that.

Speaker 2

Thank you, Will, and congratulations.

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