Insmed at Morgan Stanley Conference: Strategic Growth and Innovation

On Tuesday, 09 September 2025, Insmed Incorporated (NASDAQ:INSM) presented at the Morgan Stanley 23rd Annual Global Healthcare Conference. The company discussed its strategic advancements, highlighting significant market growth and new drug launches while addressing competitive pressures and expansion challenges.

Key Takeaways

• Insmed’s market value surged from $3 billion to $30 billion in 18 months.
• FDA-approved Bryn Supeyri launched for bronchiectasis, aiming for a smooth market entry.
• ARIKAYCE expansion could increase its market from 30,000 to 250,000 patients.
• TPIP shows promise in pulmonary hypertension, with potential for broader applications.
• Insmed is exploring collaborations in China and maintaining global pricing parity.

Financial Results

• Market value growth: $3 billion to $30 billion in 18 months.
• Cash reserves: Approximately $2 billion.
• Bryn Supeyri projected revenue: High double-digit millions for the first two quarters; $500 to $600 million for the next four quarters.

Operational Updates

• Bryn Supeyri Launch:

- First approved therapy for bronchiectasis, focusing on moderate to severe patients.

- Emphasizing disease state awareness and physician education.

- Aiming for a "frictionless launch" with strong market access and patient support.

• ARIKAYCE:

- Approved for refractory Mycobacterium avium complex lung disease.

- Expansion plans to include all NTM diagnosed patients, potentially increasing the addressable market significantly.

• TPIP:

- Positive data in PAH and PH-ILD, with expansion potential into IPF and PPF.

- Positioned as a best-in-class therapy with substantial market opportunities.

Future Outlook

• Strategic Goals:

- Aim to become a multi-billion dollar revenue company.

- Continue ARIKAYCE growth at double-digit rates.

- Positive clinical data readouts expected from various programs.

- Launch Bryn Supeyri in Europe and Japan.

• BD and R&D:

- Focus on novel, first or best-in-class mechanisms.

- Pursuing business development opportunities, including China collaborations.

• Potential Challenges:

- Navigating the bronchiectasis market and overcoming diagnosis hurdles.

- Addressing competition from China and the impact of MFN policies on pricing.

Q&A Highlights

• Bryn Supeyri Launch:

- Expectations set for a launch similar to successful drugs like Tezspire and Dupixent.

- Revenue projections align with market performance of comparable therapies.

• Competition:

- AstraZeneca previously developed Bryn Supeyri, now licensed to Insmed.

- Competitors like BI and Chinese firms are advancing similar programs.

• China:

- Recognized as a significant influence in biotech, with better performance of DPP-1 drugs in Asian populations.

For detailed insights and further information, refer to the full transcript below.

Full transcript - Morgan Stanley 23rd Annual Global Healthcare Conference:

Max Skor, Biotech Analyst, Morgan Stanley: I’m Max Skor, a biotech analyst with Morgan Stanley, and I’m honored to have Will Lewis here, CEO of Insmed Incorporated. Before we get started, I have to read some brief disclosures. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. With that, I’d like to just congratulate you and the Insmed team. It’s been an exceptional year so far. You secured FDA approval for Bryn Supeyri, delivered impressive CPIP data, and are building strong momentum going into year-end. With that, I’ll open up the floor if you have any opening remarks.

Will Lewis, CEO, Insmed Incorporated: I’ll just echo your commentary. I think we have had an extraordinary, really, last 18 months as we’ve seen our market value grow from roughly $3 billion to the current $30 billion. That value creation is all centered around three main franchises, is the way I would refer to them. One is ARIKAYCE, the approved drug for the treatment of refractory Mycobacterium avium complex lung disease. The second is Brensocatib, now known as Bryn Supeyri, for the treatment of bronchiectasis. The third is TPIP, which is for the treatment of pulmonary hypertension. Each of these can go after more than one indication, and that creates a diversified three-product, or as we like to say, three for three, a profile with multi-billion dollar compounds in each place. It’s a very enviable position to be in, and I couldn’t be more proud of what our collective team has been able to accomplish.

Max Skor, Biotech Analyst, Morgan Stanley: OK. Before we dig into Bryn Supeyri and the launch, I’d like to zoom out for a second. Insmed’s done an exceptional job identifying unmet need and delivering first-in-class therapies. Setting lifecycle management work aside for a moment, is it fair to say the road ahead is a bit more competitive in TPIP and potentially higher risk in, let’s say, your gene therapy programs like DMD and ALS?

Will Lewis, CEO, Insmed Incorporated: It’s an interesting way to think about the profile of what we are up against. In our view, we only bring forward drugs that are first or best in class. Regardless of what the competitive landscape is, if there is a competitive landscape, then we need to be best in class. I think TPIP is a good example of that. We had data where the PVR reduction, just to highlight on one data point in that PAH study, was a reduction of 35.5%, which is better than any other study, to the best of our knowledge, that’s ever been done. That really sets us up to be that best-in-class prostenoid therapy for the treatment of that condition. We would expect to keep that profile for any drug we bring forward. You made reference to our so-called fourth pillar. One aspect of that is gene therapy.

We are bringing forward DMD, ALS treatments. Those need to be best in class in a competitive landscape, and that’s the best way to bring value because we know in that circumstance we’re bringing that value to patients.

Max Skor, Biotech Analyst, Morgan Stanley: OK. In the same breath, how do you frame Insmed’s intrinsic value today? What are the most meaningful drivers of value creation going forward?

Will Lewis, CEO, Insmed Incorporated: The best way we can talk about intrinsic value creation is to look for novel mechanisms of action that are first or best in class. Those tend to spiderweb into adjacencies, other indications. If we take ARIKAYCE, this is a liposomal formulation of the antibiotic amikacin, which is inhaled and paired with an ultrasonic nebulizer, specifically targeting the macrophage within the lung so that we can eradicate, hopefully, the non-tuberculous Mycobacterium avium complex infection that is very, very difficult to get rid of. We then expand that to all NTM diagnosed patients. The Encore study that we’ll read out at the VMU next year, which is a complement to the RISE study that has already read out and was successful, should give us a clear pathway, we hope, to full approval of that drug in all MAC NTM patients.

Just to drill down on that, that takes the addressable market from 30,000 addressable patients to roughly 250,000 in the U.S., Europe, and Japan. It is a very substantial expansion. This is an indication where there is nothing else approved. It puts us in a very strong position for a very long franchise. We replicate that across all that we’re doing. Most of the Street is very focused on Bryn Supeyri and its launch in bronchiectasis. While we aren’t commenting today on the specifics of that launch because it’s just started, I can tell you that behind bronchiectasis, where we are the first ever approved therapy for that condition, and in a little footnote, that’s a condition that’s been around since 1819. For hundreds of years, companies have tried to develop therapies, and every one of them has failed until Bryn Supeyri came along.

This is a major advance in that arena, and that really motivates everybody at Insmed. Behind that, we’re looking also at CRS without nasal polyps and HS, both conditions that the clear unmet medical need exists. In CRS, there’s only an inhaled generic steroid that’s approved for treatment. In HS, there are many compounds, biologics that are primarily targeting that disease. If we can have impact in those as well, I think we really will have put our finger on DPP-1 inhibition as a kind of skeleton key for treating any neutrophil-mediated disease. We can go on as we talk about TPIP and the other compounds. They all have this profile to them. The intrinsic value is a byproduct of all of those things running in parallel in three different commercial territories, U.S., Europe, and Japan.

Max Skor, Biotech Analyst, Morgan Stanley: OK. That’s very helpful. Let’s transition to Bryn Supeyri. In light of your ARIKAYCE success, potentially moving to first line, but being the first mover in that indication, what are the learnings from that experience? How does that translate to your Bryn Supeyri launch?

Will Lewis, CEO, Insmed Incorporated: Yeah, the two are very much in parallel. ARIKAYCE was a first-in-disease indication, as I mentioned, and therefore one where there needed to be some education to physicians about the disease state itself. We took an at-risk posture and began that education process prior to approval. We had our therapeutic specialists in the field doing compliant disease state awareness and education. We have replicated that with Bryn Supeyri. We had our entire expanded sales force out in the field fully trained as of October 1 of last year, and they’ve had almost an entire calendar year to both detail ARIKAYCE in the refractory NTM setting, but also to talk about disease state awareness for this very substantial patient population of bronchiectatic patients.

Max Skor, Biotech Analyst, Morgan Stanley: OK. We have MAC patients, ARIKAYCE identifying that, and then we have bronchiectasis in Bryn Supeyri. Excuse me. Can you talk to the patient journey, how similar or different that is, patient diagnosis, the process overall of how patients go from diagnosis to potential treatment?

Will Lewis, CEO, Insmed Incorporated: The interesting thing about these two diseases is that they share a common call point in the pulmonologist. All of the infrastructure and learnings we’ve had over the last eight years that we’ve launched ARIKAYCE in the U.S. are now brought to bear in that same population of physicians for Bryn Supeyri in treatment of bronchiectasis. The patient journey is somewhat parallel in the sense that both are heavily frustrated by finally getting to a point where they have a diagnosis. Until we arrived, there’s really nothing the physician can do about it. The consequence of that is frustrated patient, frustrated physician. Along comes a therapy that can really make a material impact on our judgment on what these patients experience. In the case of Bryn Supeyri and bronchiectasis, these are so-called pulmonary exacerbations.

The field, not us, but the field talks about a vicious vortex where you have inflammation that results in poor mucociliary clearance that can result in an infection that further complicates mucociliary clearance and promotes inflammation. We use DPP-1 inhibition to inactivate the neutrophil serine proteases that are part of neutrophils and recruited to sites of inflammation in the body. This is an INI play in that sense. By breaking that inflammatory cascade, we have the ability to reduce the pulmonary exacerbations that are experienced. Pulmonary exacerbation, I liken to sort of a heart attack for the lung, does permanent damage. It, again, further complicates the mucociliary clearance and challenges that these patients face. The drug has a novel biological pathway for impacting that outcome. In this sense, it’s very exciting for the patients who have bronchiectasis.

It also implies that wherever there’s a neutrophil-mediated disease, we may have a role to play. That’s what really unlocks a whole other enormous universe in our mind of potential because behind Bryn Supeyri, we also have some 850 DPP-1 compounds that we’ve formulated in our library after our phase two data was so successful. We are now thinking about bringing those forward starting next year in new additional indications where each compound is dedicated to a separate indication.

Max Skor, Biotech Analyst, Morgan Stanley: OK. Could you just comment on the Bryn Supeyri label? It’s fairly broad. I know you’ve commented that two exacerbations may be the threshold for payers, but any color around that would be helpful.

Will Lewis, CEO, Insmed Incorporated: We think the label is, you know, we refer to it as very clean. That’s partially because the data itself was. It was a very clear statistical win on the primary endpoint and multiple secondary endpoints. We saw preservation of lung function at the 25 milligram dose as measured by FEV1. We saw trends in patients having improved symptom scores. Couple that with a safety profile that’s comparable to placebo in our estimation, and that gives you a once-a-day pill for the last substantial major pulmonary indication that has nothing to treat it where the adverse event rate is comparable to placebo. It’s just a very compelling profile for patients who want a treatment for this condition. It suggests that we have the opportunity to have a really big blockbuster in this space.

Max Skor, Biotech Analyst, Morgan Stanley: OK. Without asking for specific guidance or numbers, but just more qualitatively, what are the bigger choke points in regards to the diagnosis and potential treatment of patients with bronchiectasis? Is it CT scan, prior authorization, anything you’d call out there?

Will Lewis, CEO, Insmed Incorporated: Yeah, I think what we’ve seen is that to date there are roughly 500,000 patients in the U.S. who have an ICD-10 coded diagnosis of bronchiectasis. We estimate of those, roughly half have two or more exacerbations in the last 12 months, which is what we are centering on and targeting in our initial launch. These would be described as moderate to severe patients. By targeting those patients, we think we’re going to have a very significant impact and consequently some real benefit. We think about choke points bringing those patients in. Behind those patients, there are some 20 million patients in the U.S. that have COPD. I don’t know what the latest estimate is for asthma, but it’s another additional sizable population. Those patients are probably also including some who also have bronchiectasis.

Because the disease has nothing approved to treat it, there’s really very little motivation for the physician to come forward with a definitive diagnosis, which you can do with a CT scan and a single meeting with a pulmonologist. If you can diagnose that, now there’s a therapy to treat it. We suspect that you will see patients, as people often say, come out of the woodwork as this medicine arrives and physicians can turn and say, OK, my COPD patients who are in max dose lavalamas and are still experiencing exacerbations, I’m going to get them CT scanned, and I’m going to have them talk to a pulmonologist to make sure that this isn’t bronchiectasis that we’re seeing here. In our phase three study, about almost 20% of the patients were comorbid with COPD and bronchiectasis or asthma and bronchiectasis.

There’s quite a substantial population, we think, out there that is comorbid or misdiagnosed. That unlocks a whole new raft of patients that we think we can benefit.

Max Skor, Biotech Analyst, Morgan Stanley: From the 250,000 patients you noted with two or more exacerbations, what % of these patients have had a CT scan or have all of them?

Will Lewis, CEO, Insmed Incorporated: All of those patients that we just described have a definitive diagnosis of bronchiectasis, which requires a CT scan and a pulmonologist visit.

Max Skor, Biotech Analyst, Morgan Stanley: OK. That’s interesting. What specific levers are you using to potentially compress time to therapy and sustained adherence at scale?

Will Lewis, CEO, Insmed Incorporated: It begins with disease state awareness. We want to make sure that people are asking their patients who have symptoms that are consistent with bronchiectasis, have they had the CT scan. Now that there’s a therapy out there to treat it, it will really motivate, we think, both patients and physicians to take a closer look. As that process unfolds, I think you’re going to not only see more patients diagnosed, more documentation of exacerbations, but we’re really going to be able to unlock, and very much like in other therapeutic areas, start to slice up the pulmonology patient populations along the lines of those who have COPD exclusively, COPD with bronchiectasis, just bronchiectasis, asthma, and shades of gray around that.

That specialization of identification and treatment of those patient populations is the way that most major disease states ultimately go once there’s an ability to really refine and define in an understandable way what is the specific challenge that each patient faces.

Max Skor, Biotech Analyst, Morgan Stanley: OK. That’s helpful. If you can outline potential guardrails or milestones over the next 12 to 16 months so we can better understand the launch progression, I know you’re not going to be providing script data or anything. We shouldn’t be watching that. Overall, how can we get an understanding of penetration in the bronchiectasis patients? Are you pulling patients from COPD and asthma? What could you comment there?

Will Lewis, CEO, Insmed Incorporated: Yeah, so we’re going to watch this unfold. We have an absolutely first-rate commercial effectiveness team at Insmed that is very focused on collecting more data than you could possibly imagine to be sure that we understand exactly what is happening with these various patient journeys and where are their friction points, where are their opportunities to intervene to try to help patients even more in a compliant way. I feel very good about the way this launch should go. We’re not commenting on the launch itself, but coming into the launch, we’d had extensive dialogue with market access. We wanted what we referred to as a frictionless launch. That means ensuring that when a patient is given a prescription, they can get it fulfilled and get access to the medicine quickly. Once on the medicine, we want to provide the option to have a patient support capability for them.

That is very much in place. We saw that work extremely well with ARIKAYCE and that program. We’re doing that again here for bronchiectasis. As we move forward on a quarterly basis, we’ll certainly report what’s going on with the launch. We’ve set our bar for where we want to go across a spectrum of other drugs that have performed exceptionally well. Think of Tezspire, think of Ofev, think of Fasenra, think of Dupixent. When you look at the average of those drugs, that gives you a ballpark of what we think good in this space looks like. We would be disappointed if we didn’t approach those kinds of results. Specifically, what that means, in the first two full quarters, we would expect those group of drugs to produce roughly high double-digit million revenue combined. For quarters three through six, combined somewhere in the $500 to $600 million revenue range.

That’s not guidance. That’s what good looks like in this space. We would like to be within reach of that if we could be.

Max Skor, Biotech Analyst, Morgan Stanley: OK. Based on your market research, talking to KOLs, where do you think pulmonologists fall on the first batch of patients they’d like to put on therapy initially?

Will Lewis, CEO, Insmed Incorporated: We think of this broadly as the community pulmonologist and then the sort of KOL specialist at the academic center. They’re very different profiles. The KOLs are probably seeing dozens of patients. The community pulmonologists may be just a handful or one or two. I think their approach is going to be slightly different. Almost to a person, the KOLs we’ve known over the last eight years that we’ve been bringing ARIKAYCE to the market have been enthusiastic supporters of Bryn Supeyri’s potential role, Bryn Supeyri’s role in the treatment of bronchiectasis. Consequently, now that it’s approved, I think you’ll hear them vocally supporting and advising its use in the appropriate patient population. I think the community-level physician will respond to that and take some of that guidance on board. There will ultimately be consideration of things like guidelines.

The COPD Foundation, as an example, is running a program to qualify up to 150 different centers across the United States that are particularly qualified to treat NTM and bronchiectasis. As those come online, those centers of excellence will also be folks that’ll be pretty prominently involved in identifying and treating their patients. We know coming into this, we had north of 90% of physicians saying they were inclined to use this drug to treat the condition in their patients. We had more than, I don’t know, it was close to 70,000 self-identified patients sign up on our website to get more information. The patient demand is there. The physician appetite is there. We just need to put these folks together and make sure that that process goes smoothly in a compliant way.

Max Skor, Biotech Analyst, Morgan Stanley: You clearly have a first-to-market advantage, but success often defines a category and attracts competition. Can you comment on the competitive landscape here and your thoughts going forward?

Will Lewis, CEO, Insmed Incorporated: Yeah, if we start and take a look at who else is out there with a DPP-1 inhibitor, this class was originally pursued by GlaxoSmithKline, AstraZeneca, BI, and all three of them dropped their programs. In fact, it was AstraZeneca that called us and said, look, we’re going to drop this program, but you may be able to find a use for it in a rare condition like bronchiectasis. Going back in time to 2016 when we did this transaction, first of all, bronchiectasis was thought to be an orphan disease. Secondly, the definitive paper published by James Chalmers out of Scotland that correlated reduction in neutrophil elastase with reduction in pulmonary exacerbations had not yet been published. People sometimes go and pick on AstraZeneca for having outlicensed this drug to us. At the time, they were being pursued by a larger company called Pfizer.

They had some things on their mind, and they were getting rid of some things that they weren’t developing. The data was not there to support the drug’s use in the way that we have seen it evolve. In their defense, that was not clear. It was about two or three months after we enlicensed it that the paper was published, and the FDA changed bronchiectasis into being a non-orphan condition, in which case they came back and knocked on the door and said, any chance we can get that drug back? Of course, we said, no, sorry, but thank you very much. We look forward to working with you, and we have collaboratively since then. I give them high marks.

They took a drug that was going to sit on the shelf, and they put it in the hands of somebody that was going to take a chance in developing it. Today, we sit here with the first ever approved therapy for bronchiectasis. I think that’s a victory we share with AstraZeneca.

Max Skor, Biotech Analyst, Morgan Stanley: OK. Just briefly on Verona, Merck’s product and COPD, do you see any risk to them, let’s say, expanding into bronchiectasis? Granted, you’re trying to go from bronchiectasis to COPD, but how do you think about that dynamic?

Will Lewis, CEO, Insmed Incorporated: We’re not going to go into COPD with our drug, just to be clear. There are some COPD patients who may have bronchiectasis, and that nuance is important just for understanding. The Verona drug is an exciting addition to the armamentarium of the treatment of COPD patients. As I was describing earlier, if you look at the COPD category, it’s 20 million patients in the U.S. There are subtleties of profile of COPD patients that are going to be more suitable for the Verona drug or, if they have bronchiectasis, for our drug. That nuance will get teased out. We don’t see them as a competitive threat. You asked earlier who the other competitive programs are. BI reactivated their program after our phase two data came out, and they are right now kicking off a phase three study in bronchiectasis.

There’s another compound that, not surprisingly, came out of China and is being developed. The data in that population look interesting. I don’t think either one of those are necessarily competitive with ours because we’re now approved. They’re going to have to explain why it’s substantially better or additive to what we have. It is good to see attention turned to the class. I think there are a lot of places where there are neutrophil-mediated diseases where DPP-1 inhibition may be applicable. That is why we went off and developed another 850 of these compounds so that we can target these diseases systematically, one at a time.

Max Skor, Biotech Analyst, Morgan Stanley: OK. You have two additional readouts, HS, CRS without nasal polyps. Could you level set expectations going into those readouts? How should we think about them and benchmark expectations a bit?

Will Lewis, CEO, Insmed Incorporated: We looked, when we were first developing the drug, at what other indications we might want to target. That list is very long. There are a number of neutrophil-mediated diseases. We picked CRS without nasal polyps because that’s a condition that some people, in a simplistic sense, often refer to as sort of bronchiectasis for the nasal passage. There’s some comparability there, neutrophil-driven. There isn’t a clear unmet medical need. There’s only a generic inhaled steroid that’s available for treatment. That condition numbers 32 million people in the United States. It is massive. We’re going to be targeting the severe end of that spectrum, and we’re very excited about the possibility of having a dent there. If we can make an impact there, we’ve just added a disease indication where we would be the first truly novel biology in that indication, meeting our first or best-in-class definition.

It is one that is larger than the bronchiectasis opportunity. Another very significant milestone will lead out for us between now and the end of the year in that indication. HS follows behind that next year. HS is a more complex disease etiology, and I think from that perspective, while we’re excited about the potential, we’re a little more cautious about the possibility of DPP-1 having impact there. We are going to look at the first 100 patients and do a kind of futility analysis, have that read by an outside group of experts, and they’ll give us a thumbs up, thumbs down, the study should continue or not. That data will be available in the early part of next year. We don’t want to waste time on behalf of patients with a drug that we don’t think will work.

There aren’t great animal models in this, so this is really the only way to find that balance. If that’s a thumbs up and that trial continues, that would be a very exciting development.

Max Skor, Biotech Analyst, Morgan Stanley: OK. Maybe in the last 10 minutes or so, we pivot to TPIP. Impressive readout in PAH. The Teton trial recently read out. How are you thinking about the opportunities there and the cadence of readouts to come?

Will Lewis, CEO, Insmed Incorporated: Yeah, here we go. TPIP had great data in PAH. It had great data in PH-ILD. Now it has the possibility of going after two additional indications, IPF and PPF. Those were somewhat validated by the United Therapeutics study that just came out that showed Tyvaso having a benefit in IPF patients. I think collectively, most people felt that it was non-obvious that our drug would work in those indications. Given what was seen with the Tyvaso, we’re now very encouraged by that. We intend to go after both of those indications. We actually had the protocol written before the data came out, just in the off chance that it was going to be good or close enough. We know our drug does better than Tyvaso in PAH. We’ve already established that with our data. We think here the same will be true.

That gives us access to four indications from this one compound. That is a very substantial opportunity. Just to put this in context, people know the drug sotatercept, which was at Acceleron, purchased by Merck for about $11.5 billion after their phase two data. The peak sales estimate when that was done was about $1.5 billion. Today, approved, it sits at a peak sales estimate of around $8 billion. That’s just for PAH. We’re talking about our drug being best-in-class for the treatment of PAH, PH-ILD, potentially IPF, and PPF. This is a very substantial drug. As much as people pay attention to Bryn Supeyri and how exciting that could be, I think TPIP is every bit as exciting.

Max Skor, Biotech Analyst, Morgan Stanley: OK. The first readouts to come will be PH-ILD, then PAH. Is there any opportunity to potentially compress timelines? How have interactions been going with regulators?

Will Lewis, CEO, Insmed Incorporated: Internally, I think everybody loves when I show up and ask, is there any way we can compress timelines? That is the clarion call of everybody inside biotech. Happily, we have some precedent here when we look at the Aspen data. That study was 450 centers around the world, 1,700 patients conducted during COVID. Our team did a first-class, world-class job in getting that enrolled in less than two years. I am very optimistic that we can bring that same innovative approach to PAH, PH-ILD, and get those done sooner rather than later, then turn our attention, of course, to IPF and PFF. If we can get those completed and the data is as consistent as it has been to date, boy, we have another whole series of launches that we can expect to be forthcoming.

Max Skor, Biotech Analyst, Morgan Stanley: OK. Now moving to, I guess, financials or just the path ahead overall, how do you balance commercial scale-up for Bryn Supeyri, late-stage development, TPIP, early research velocity, and BD while also protecting your P&L on a path to profitability?

Will Lewis, CEO, Insmed Incorporated: Yeah, I think most people who are investors know that we go for it. I’ve been at this company for 13 years. When I joined, there were roughly 30 people, and our market value at the time was $75 million. We had $75 million in the bank. Basically, Wall Street thought the drugs were worth zero. It turns out that the one drug, ARIKAYCE, did have a role to play in refractory NTM. With that conditional approval in the U.S., we were off to the races. On the basis of that, we have laddered in other opportunities. At every turn that we have made a major advance, we’ve taken that moment to both capitalize ourselves and to go out and look for modest additional business development opportunities. When ARIKAYCE looked good, we went out and bought Brensocatib.

When Brensocatib looked good, we went out and did about half a dozen different platform technology acquisitions, which were all very modest upfront, success-based milestones. Those are now getting ready to start to read out. That has created a company composition which has, I think, in many ways, a very enviable profile. We’re three for three with our late-stage, very substantial multi-billion dollar opportunities. We have another 30 compounds that are in preclinical development now just entering the clinic across those different platforms. These technologies are unrelated to one another in many ways. Synthetic rescue out of Cambridge, England. We have DNA-therapeutic proteins out of New Hampshire. We have gene therapy out of San Diego. We have next-gen DPP-1 and novel MOAs to complement DPP-1 coming out of New Jersey.

All of that research we say will keep below 20% of overall spend, but it sort of ticks away in the background. Those acquisitions, for example, we did about four years ago, and they’re just now starting to round the corner to provide clinical data. Just as ARIKAYCE expands, Brensocatib goes into bronchiectasis, and we read out CRS and HS, TPIP goes after four separate indications with promising data. We’ll begin to add new clinical compounds at the rate of one to two INDs a year with clinical data that we think will, again, meet the criteria of first or best-in-class. That gives us a very clear line of sight for the next three to five years for value creation from where we are today, which has been a substantial growth, but is really just the beginning.

Max Skor, Biotech Analyst, Morgan Stanley: OK. In the near term, or relatively near term, the next 6 to 12 months, I mean, hopefully, we’re sitting down again next year. What three outcomes would you want to point to as proof that Insmed’s tracking towards a multi-billion dollar portfolio?

Will Lewis, CEO, Insmed Incorporated: We better start to put up a multi-billion dollar revenue line. I think the honest answer is we need to see the performance of Bryn Supeyri in bronchiectasis. We need to see ARIKAYCE, now in its eighth year in the U.S., continue to grow at double-digit rates. We’ve seen that consistently. We want to see these clinical data readouts from CRS, HS, ALS, DMD, Encore, DPP-1 next generation, all of that while we’re launching in Europe and Japan for Bryn Supeyri in the treatment of bronchiectasis. If all that comes to fruition within the next roughly 12 months, which is what we’re on track for, we should see substantial, in our opinion, value creation from where we are today.

This is almost like a freight train that has gotten going, and we’re building that momentum around these positive readouts to get us to a place where we can continue to bring benefit for patients. We’re doing it with a balance sheet that’s close to $2 billion right now in terms of cash and equivalents on our balance sheet.

Max Skor, Biotech Analyst, Morgan Stanley: Bryn Supeyri is launching in the third quarter, but the fourth quarter is going to be the first full quarter. Can we expect, let’s say, a competitor conference in early January being a key catalyst for investors to get a sense of how the launch is going?

Will Lewis, CEO, Insmed Incorporated: I think that’s a fair guess in terms of when we might put out that first full quarter of data. We will also, by then or just before then, have our CRS data as well. Shortly thereafter, we’ll be looking for Encore and HS. We’ll begin to see the news flowing from the next-generation DPP-1 inhibitors as they enter the clinic and the multiple gene therapy programs that we’ve already described.

Max Skor, Biotech Analyst, Morgan Stanley: OK. We’ve been asking some of our companies some survey questions. With China on the rise in regards to biotech innovation, how are you thinking about your competitive position there? Will this influence your R&D or BD strategy?

Will Lewis, CEO, Insmed Incorporated: In my opinion, China is the single biggest influence and impact on our sector. I think not all, but many people willfully underestimate how advanced they are and what a profound impact they’re going to have on our industry. People make a distinction between whether or not what they’re doing is truly innovative versus copycat. I think that is going to be lost in the shuffle. The volume that they bring to bear, resources, talent, and first-class facilities are just second to none. If you’re in this sector and you don’t have a China strategy, you’re behind.

Max Skor, Biotech Analyst, Morgan Stanley: Do you think BD could come from China next?

Will Lewis, CEO, Insmed Incorporated: Absolutely. I would be thrilled to bring in additional compounds from China into the West, just as China is developing them for the East. I think that is very likely to be a way a lot of people pursue business development. If you look at what’s going on right now, many companies have announced programs that they’ve in-licensed as fast followers from China. There’s a DPP-1 coming out of BI that I talked about. There’s also one from a company called Hysco over in China. Just to refine the point, in DPP-1, the performance of that drug in people of Asian descent is dramatically better than it is in Caucasians. When we look at our data, we had a 20% reduction in exacerbations. In our Asian population, it was north of 60%.

Not clear why that is, but it’s an example of why the nuance of where you’re developing the drug and how you’re doing your research can be quite important.

Max Skor, Biotech Analyst, Morgan Stanley: OK. Last question. What has been most impactful from a regulatory side? Would you say FDA, MFN, or tariffs?

Will Lewis, CEO, Insmed Incorporated: In terms of impactful, I would have to say the FDA’s interaction because it was, you know, by the numbers, straight down the line. We didn’t have any difficulty. Obviously, with the recent approval, that came to a wonderful conclusion for patients and for us. We didn’t see any of the difficulties that we’ve been reading about perhaps in the news. In terms of potential threat, I think the intention behind MFN is right on the money. The problem is enforcing that and the way it’s being handled is probably going to backfire. I don’t know that that’s going to be a successful storyline, which is unfortunate. For us, we’re in a good position because when we launched our last drug, we did it at list price parity around the world. That would be our intention with drugs that we bring forward.

Discounting that happens in other countries is a part of their system. We can’t control that. We can certainly show up and say we think everybody should be paying the same price for the same drug.

Max Skor, Biotech Analyst, Morgan Stanley: OK. With that, Will, thank you very much. I really appreciate it and look forward to seeing how the launch goes.

Will Lewis, CEO, Insmed Incorporated: My great pleasure. Thank you.

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