Insmed Incorporated (INSM) Earnings Call Transcript & Summary

I'm Max Skor, a biotech analyst with Morgan Stanley, and I'm honored to have Will Lewis here, CEO of Insmed. Before we get started, though, 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. So with that, I'd like to just congratulate you and the Insmed team on what's been an exceptional year so far. You secured FDA approval for Brinsupri, delivered impressive TPIP data and are building strong momentum going into year-end. With that, I'll open up the floor if you have any opening remarks.

Well, I'll just say I 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, and 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 MAC lung disease. The second is brensocatib, now known as Brinsupri for the treatment of bronchiectasis. And 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 3 product or as we like to say, 3 for 3 profile with multibillion-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.

Okay. So before we dig into Brinsupri and the launch, I'd like to zoom out for a second. Insmed has done an exceptional job identifying unmet need and delivering first-in-class therapies. So setting life cycle 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?

So 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. So regardless of what the competitive landscape is, if there is a competitive landscape, then we need to be best-in-class, and 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, the best of our knowledge, that's ever been done, and that really sets us up to be that best-in-class prostanoid therapy for the treatment of that condition, and we would expect to keep that profile for any drug we bring forward. You've 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.

Okay. And then in the same breath, how do you frame Insmed's intrinsic value today? And what are the most meaningful drivers of value creation going forward?

So 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, and those tend to spiderweb into adjacencies, other indications. If we take ARIKAYCE, this is a liposomal formulation of the inhaled antibiotic -- 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 nontuberculous mycobacteria avium complex infection that is very, very difficult to get rid of. We then expand that to all NTM diagnosed patients and the ENCORE study that will read out the beginning of 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, and 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. So it's a very substantial expansion. This is an indication where there is nothing else approved. So it puts us in a very strong position for a very long franchise, and we replicate that across all that we're doing. Most of the Street is very focused on Brinsupri and its launch in bronchiectasis, and 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 Brinsupri came along. So this is a major advance in that arena, and that really motivates everybody at Insmed. But 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. And 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 DPP1 inhibition as a kind of skeleton key for treating any neutrophil-mediated disease. And we can go on as we talk about TPIP and the other compounds. They all have this profile to them. So the intrinsic value is a byproduct of all of those things running in parallel in three different commercial territories, U.S., Europe and Japan.

Okay. That's very helpful. And then let's transition to Brinsupri. And in light of your ARIKAYCE success, potentially moving the first line, but being the first mover in that indication, what are the learnings from that experience? How does that translate to your Brinsupri launch?

Yes. 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, and we had our therapeutic specialists in the field doing compliant disease state awareness and education. We have replicated that with Brinsupri. So we had our entire expanded sales force out in the field fully trained as of October 1 of last year, and so 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.

Okay. So we have MAC patients, ARIKAYCE identifying that, and then we have bronchiectasis and Brinsupri, excuse me. How -- could 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.

Well, the interesting thing about these two diseases that they share a common call point in the pulmonologist, and so all of the infrastructure and learnings we've had over the last 8 years that we've launched ARIKAYCE in the U.S. are now brought to bear in that same population of physicians for Brinsupri in the 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, and until we arrived, there's really nothing the physician can do about it, and the consequence of that is, frustrated patient, frustrated physician, and so along comes a therapy that can really make a material impact in our judgment on what these patients experience. In the case of Brinsupri 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. So we use DPP1 inhibition to inactivate the neutrophil serine proteases that are recruited by -- that are part of neutrophils and recruited to sites of inflammation in the body. So this is an I&I play in that sense, and by breaking that inflammatory cascade, we have the ability to reduce the pulmonary exacerbations that are experienced. A pulmonary exacerbation, I liken into sort of a heart attack for the lung does permanent damage and it, again, further complicates the mucociliary clearance and challenges that these patients face. So the drug has a novel biological pathway for impacting that outcome, and in this sense, it's very exciting for the patients who have bronchiectasis, but it also implies that wherever there's a neutrophil-mediated disease, we may have a role to play, and that's what really unlocks a whole other enormous universe in our mind of potential because behind brensocatib, we also have some 850 DPP1 compounds that we've formulated in our library after our Phase II data was so successful, and we are now thinking about bringing those forward starting next year in new additional indications where each compound is dedicated to a separate indication.

Okay. And then can you just comment on the Brinsupri 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.

So we think the label is -- 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. So 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, and it suggests that we have the opportunity to have a really big blockbuster in this space.

Okay. Without asking for specific guidance or numbers, but just more qualitatively, what are the bigger choke points in regards to diagnosis and potential treatment of patients with bronchiectasis? Is it CT scan, prior authorization? Anything you'd call out there?

Yes. 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, and by targeting those patients, we think we're going to have a very significant impact and consequently, some real benefit. We think about chokepoints bringing those patients in, behind those patients, there are some 20 million patients in the U.S. that have COPD, and 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, but 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, and if you can diagnose that, now there is a therapy to treat it. So 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, okay, my COPD patients who are max dose LABA/LAMAs 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 III study, about almost 20% of the patients were comorbid with COPD and bronchiectasis or asthma and bronchiectasis. So there's quite a substantial population, we think, out there that is comorbid or misdiagnosed, and that unlocks a whole new raft of patients that we think we can benefit.

And from the 250,000 patients you noted with two or more exacerbations, what percentage of these patients have had a CT scan or have all of them?

All of those patients that we just described have a definitive diagnosis of bronchiectasis which requires a CT scan and a pulmonologist visit.

Okay. That's interesting. So what specific levers are you using to potentially compress time to therapy and sustained adherence at scale?

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, and 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.

Okay. That's helpful, and I guess 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. But overall, how could we get an understanding of penetration in the bronchiectasis patients? Are you pulling patients from COPD and asthma? What could you comment there?

Yes. 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 there friction points where there are 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've had extensive dialogue with market access. We wanted what we refer 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, and that is very much in place. We saw that work extremely well with ARIKAYCE and that program. So we're doing that again here for bronchiectasis, and as we move forward, on a quarterly basis, we'll certainly report what's going on with the launch, but 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, and 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, and then for quarters 3 through 6, combined somewhere in the $500 million to $600 million revenue range, that's not guidance. That's what good looks like in this space. So we would like to be within reach of that if we could be.

Okay, and 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?

So we think of this broadly as the community pulmonologist and then the sort of KOL specialist at the academic center. They are very different profiles. The KOLs are probably seeing dozens of patients. The community pulmonologists may be just a handful or 1 or 2, and so I think their approach is going to be slightly different. Almost to a person, the KOLs we've known over the last 8 years that we've been bringing ARIKAYCE to the market have been enthusiastic supporters of brensocatib's potential role, Brinsupri role in the treatment of bronchiectasis, and 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 and 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, and as those come online, those centers of excellence will also be folks that will 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, and we had more than, I don't know, it's close to 70,000 patients, self-identified patients sign up on our website to get more information. So 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.

Okay. So 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?

Yes. If we start and take a look at who else is out there with a DPP1 inhibitor, this class was originally pursued by GlaxoSmithKline, AstraZeneca, BI and all three of them dropped their programs. In fact, it was AZ 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, and 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. So people sometimes go and pick on AZ for having out-licensed this drug to us. At the time, they were being pursued by a larger company called Pfizer, so 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, and so in their defense, that was not clear. It was about 2 or 3 months after we in-licensed 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. And of course, we said, no, sorry, but thank you very much, and 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. And today, we sit here with the first ever approved therapy for bronchiectasis. And I think that's a victory we share with AstraZeneca.

Okay. And then just briefly on Verona Merck's product in 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?

So we're not going to go into COPD with our drug, just to be clear, but 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, and 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, and that nuance will get teased out. But we don't see them as a competitive threat. You asked earlier who are the other competitive programs. BI reactivated their program after our Phase II data came out, and they are right now kicking off a Phase III study in bronchiectasis. There's another compound that not surprisingly came out of China and is being developed and the data in that population look interesting. I don't think it's -- either one of those are necessarily competitive with ours because we're now approved. So they're going to have to explain why it's substantially better or additive to what we have. But it is good to see attention turning to the class. And I think there are a lot of places where there are neutrophil-mediated diseases where DPP1 inhibition may be applicable, and 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.

Okay. So you have two additional readouts, HS, CRS with nasal polyps. Could you level set expectations going into those readouts? How should we think about them and benchmark expectations a bit?

So we looked when we were first developing the drug at what other indications we might want to target, and 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. So 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, and 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. So again, meeting our first or best-in-class definition, and it is one that is larger than the bronchiectasis opportunity. So another very significant milestone will read 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 DPP1 having impact there, but 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, and 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.

Okay. So 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?

Yes, here we go. So TPIP had great data in PAH. It had great data in PH-ILD. And now it has the possibility of going after 2 additional indications, IPF and TPF, and 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 nonobvious that our drug would work in those indications. But given the -- what was seen with Tyvaso, we're now very encouraged by that, and 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. So we think here, the same will be true, and that gives us access to four indications from this one compound, and 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 II 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, and 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 PFF. So this is a very substantial drug. As much as people pay attention to Brinsupri and how exciting that could be, I think TPIP is every bit as exciting.

Okay. And so the first readout to come will be PH-ILD, then PAH. Is there any opportunity to potentially compress time lines? And how have interactions been going with regulators?

Internally, I think everybody loves when I show up and ask, is there any way we can compress time lines because that is the clearing 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, and our team did a first-class, world-class job in getting that enrolled in less than 2 years. So I'm very optimistic that we can bring that same innovative approach to PAH, PH-ILD and get those done sooner rather than later and then turn our attention, of course, to IPF and PFF, and 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.

Okay. So now moving to, I guess, financials or just the path ahead overall. How do you balance commercial scale up for Brinsupri, late-stage development, TPIP, early research velocity and BD while also protecting your P&L on a path to profitability?

Yes. I think most people who are investors know that we go for it. I've been at this company for 13 years. And when I joined, there were roughly 30 people, and our market value at the time was $75 million, and we had $75 million in the bank. So basically, Wall Street thought the drugs were 0. It turns out that the one drug, ARIKAYCE, did have a role to play in refractory NTM, and with that conditional approval in the U.S., we were off to the races, and on the basis of that, we have laddered in other opportunities and 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. So 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, and those are now getting ready to start to read out, and that has created a company composition which has, I think, in many ways, a very enviable profile. We're 3 for 3 with our late-stage, very substantial multibillion-dollar opportunities, and we have another 30 compounds that are in preclinical development now just entering the clinic across those different platforms, and these technologies are unrelated to one another in many ways, synthetic rescue out of Cambridge, England. We have deimmunized therapeutic proteins out of New Hampshire. We have gene therapy out of San Diego, and we have next-gen DPP1s and novel MOAs to complement DPP1 coming out of New Jersey, and 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 4 years ago, and they're just now starting to show around the corner to provide clinical data. So just as ARIKAYCE expands, brenso goes into bronchiectasis and we read out CRS and HS and TPIP goes after four separate indications with promising data, we'll begin to add new clinical compounds at the rate of 1 to 2 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 3 to 5 years for value creation from where we are today, which has been a substantial growth, but is really just the beginning.

Okay. And then near term or relatively near term, the next 6 to 12 months, I mean, hopefully, we're sitting down again next year, but what 3 outcomes would you want to point to as proof that Insmed is tracking towards a multibillion-dollar portfolio?

Well, we better start to put up a multibillion-dollar revenue line. I think the honest answer is, we need to see the performance of brensocatib in bronchiectasis. We need to see ARIKAYCE now in its eighth year in the U.S. continue to grow at double-digit rates, and we've seen that consistently. We want to see these clinical data readouts from CRS, HS, ALS, DMD, ENCORE, DPP1 next generation, all of that while we're launching in Europe and Japan for Brinsupri 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, and 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.

Okay. So Brinsupri is launching in the third quarter, but the fourth quarter is going to be the full -- first full quarter. So 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?

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, and then shortly thereafter, we'll be looking for ENCORE and HS, we'll begin to see the news flowing from the next-generation DPP1s as they enter the clinic and the multiple gene therapy programs that we've already described.

Okay. And 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? And will this influence your R&D or BD strategy?

In my opinion, China is the single biggest influence and impact on our sector. I think not all, but many people woefully 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 and resources and talent and first-class facilities are just second to none, and if you are not -- if you're in this sector and you don't have a China strategy, you're behind.

So do you think BD could come from China next?

Absolutely. I would be thrilled to bring in additional compounds from China into the West, just as China is developing them for the East, and 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 DPP1 coming out of Boehringer Ingelheim that I talked about. It's also one from a company called Haisco over in China, and just to refine the point, in DPP1, the performance of that drug in people with Asian descent is dramatically better than it is in Caucasians. So when we look at our data, we had a 20% reduction in exacerbations. In our Asian population, it was north of 60%. It's 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.

Okay. Last question. What has been most impactful from a regulatory side? Would you say FDA, MFN or tariffs?

In terms of impactful, I would have to say the FDA's interaction because it was by the numbers straight down the line, we didn't have any difficulty. And 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. And I don't know that, that's going to be a successful storyline, which is unfortunate. But 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, and that would be our intention with the drugs that we bring forward. Discounting that happens in other countries as a part of their system, we can't control that. But we can certainly show up and say we think everybody should be paying the same price for the same drug.

Okay. So with that, Will, thank you very much. I really appreciate it and look forward to seeing how the launch goes.

My great pleasure. Thank you.