Newsfilter article unlocker

Enter Newsfilter article ID in the field below.
Example: https://newsfilter.io/articles/39be1bef03e66cdc886c08a2a6319c47

Retrieved article
Well, thank you so much, everybody. Thank you for joining us, Thomas and Julie, from BridgeBio. It's really nice to have you here. And we'll kick it off first with you guys presenting some slides and giving an overview before we start with the Q&A. Great. Thank you so mucho for having us, Jeffrey, and thanks to the whole Bernstein team. Thomas from RK, President and CFO of BridgeBi, I'm joined by Julie Miller-Everett, our Chief Operating Officer of Osceola Displacials Business. Many of you will know Julie from her critical role in the Atribi launch and we've just moved her over to help with the InfraGratnib launch where she brings more than a decade of commercial experience particularly in the ultra rare and and skeletal dysplasia space so really privileged to have her with me here today. Maybe I'll start just by saying a few words and setting some context for hopefully a great dialogue here with you today Jeffrey. So BridgeBio Bio is a company that, at the highest level, we're here in this world to help as many patients living with genetic disease as we possibly can in the shortest amount of time that we can get that done. And we do that through creating first or best in class medicines and putting them out into the marketplace. Today the business late stage portfolio is incredibly unique, I would say. If you've studied the industry, you're certainly looking at it today, as I know you are. So first, we've got Atruby, which is our best-in-class, near-complete stabilizer for ATTR cardiomyopathy. We're about six quarters into that launch. The importance of that launch to our business cannot be overstated. So at once, I think that has proven us as a capable commercial organization, and I thinkthat is widely regarded as one of the better biotech launches we've seen in recent years, annualizing north of a billion today globally, on track to be on the full year basis blockbuster status globally by the end of this year. Really that's owed to a few things. First, this is a large and expanding marketplace. We're seeing something like 15, 16,000 patients come to the bottom of the funnel every year. So really, really attractive from a patient need standpoint. And I think we have clearly a differentiated and best-in-class stabilizer, which are, you know, post some of the recent data sets, I would say, solidified as the backbone of first-line therapy. So really, really exciting molecule there. And actually this morning, we had some incredibly important news come out. We published the first of its kind real-world data set comparing Atruvi directly to tefamidus, where we've seen about a third improvement in the composite of including all-cause mortality and CV hospitalization. So really important data set that has not really yet been disseminated into the marketplace and impacted prescribing behaviors, but that will take place over the coming year. So it really proves us out as a competent commercial organization and also I think gives us the confidence to launch the next three products, not only in the US but globally. So I think the truly unique thing about BridgeBio today is that still early days of one product launch and another three coming in the next year. So we've got LimbGirdle 2i, which is first in class molecule for a high-emit need for muscular dystrophy. There we've a product that can actually remarkably improve function on several fronts. One, patients are able to breathe better than when they started therapy. They're able to walk better and they're able to actually, through measure of general symptom scores like the North Star, restore overall function and in a statistically significant way against placebo. So really, really exciting molecule there that's gonna do a lot of good for patients. This is a clear billion dollar opportunity. ADH1 in calories, another small molecule that's read out phase three in the last year or so. Again, basically functionally cured about 76% of the patients in our phase three, so really important data set that's gonna change a lot of lives in this marketplace. And there again, we've got a billion dollar opportunity, no competition, looking forward to building that market. Finally, achondroplasia, which I hope we have plenty of time to speak about given we've had Julie with us. This is today, a billion-dollar marketplace where we're gonna come in with a clearly distinct, differentiated and unique molecule, first and only oral in the space, and a pivotal data set that really is giving the market exactly what it's been asking for for many years, which is really a profound effect on height, but more importantly, a compelling effect on the health of these children, whether it's proportionality or some of the things we've been able to demonstrate recently, including an effect on sleep apnea and ear infection. So overall, big picture, Atruby we see is on track deliver four billion plus in peak year sales and then we've got another four billion I would say de-risked and about to you know see see uptake into the marketplace next year with expansion available to us beyond that and there's some interesting opportunities including hypochondriplasia and other skeletal dysplasias as well as post-surgical hypoparathyroidism so that's the opportunity in the next 18 months I would Say beyond that our hope is that we can create many many new meaningful medicines for patients beyond the four that I talked about and have a durable business that can grow for many decades and so beyond the four products that hopefully we'll spend most time on today we've got had we've had a very prolific productive discovery engine that's continued to put molecules in the clinic so I think when the time is right we can access some of that pipeline growth it's housed today in our sister company called Gondola bio, which is private. So with that long-winded, perhaps, context setting, maybe we can get right into the Q&A. It was a great context setting. And yes, we'll definitely touch on a lot of these drugs as we're doing our conversation and excited to hear more. So maybe even maybe taking just a step back just as an introduction. Love to hear what both of you think is sort of the DNA of the company. You know, what makes BridgeBio tick and why are you so successful? You know thank you for saying that I would say two things in my mind are different and special about this company first and this comes back to the patient impact mission we really try and work on diseases where there's both a tremendous unmet need out of the community either either there's no available therapy today or existing therapies are inadequate and we try to work on disease is where we can ask how How do we drive a large magnitude of impact for patients? And for us, that usually brings us to conditions where we can take a complicated biological problem and convert it to something much more like an engineering issue where we kind of connect all the dots between genetics and what we need to do to the target and how we affect it to translate to symptoms and outcomes for patients. And when you do that, I think you can, A, drive probability of technical success even beyond the all-comer kind of genetic disease levels and I think we've demonstrated for the first 10 years that we can do that and be it lets you really have a clear thesis on what your therapeutic hypothesis is that when it's not working and it's no longer intact you can kill it and reallocate resources elsewhere so that's I think one thing in terms of the operating system that is unique is a lot of space accessible to from a business standpoint you know I I think we catch a little bit of flack from time to time from investors for spending too much time talking about MPV, but it actually does matter if you wanna create a business that is gonna be durable for generations to come. You really have to be focused on, am I investing in a way that's gonna allow me to be sustainable from an economic standpoint? I think clearly, if you look at the opportunity for us to transition our P&L over the next 18 months, I think that clearly has benefited us to date. So those are two things that pop into the top of my mind. But Julia? Well said. I would just add one more, which is that we have truly differentiated clinical science and outcomes. And when you look at kind of the two pillars that we're building as an organization right now for commercial execution, we have hyper-competitive markets like amyloidosis and achondroplasia, where we have best-in-class products that are truly differentiated if you follow the science and the literature. And then we have Pillar 2, which is these traditional rare disease markets where we're building a market based on clinically defined conditions, well-articulated science, high unmet needs. So I think that's really what differentiates us, is having a scientific but also commercial organization that's able to develop drugs and then execute across both pillars. That's excellent. And maybe kicking it off, you gave a really nice overview that highlighted some of your four key drugs in the near term and on market now. I'd love to maybe just start with Atruby. Give us an overview, any additional information you want to share beyond your nice introduction up front and how important it is for patients and for the company. Yeah, absolutely. So Atruvi, yeah, as I mentioned, that's annualizing today at north of a billion, just six quarters into launch. And it's a really interesting moment for this product where we see a large and continuously expanding market. As I mentioned 15,000, 16,000 new patients a year right now today is our estimate. Just two years ago that was more like 8,000. Last year it was something like 10,000 to 12,000 was our estimate, so we continue to see strong momentum for the market overall and at the same time we continue to grow our share of the market and and i think we're really entering i would say kind of a second chapter of the attribute launch the first six quarters were really about getting out there getting into the centers of excellence establishing ourselves as the new player the differentiated player and really grabbing market share with our initial marketing message that were really anchored around the primary analysis from our phase three study, so three, 42, 50, three month separation, 42% reduction in hospitalizations and mortality, and a 50% reduction hospitalizations, which by the way, giving a shifting patient population most events that occur in this population today are hospitalizations. So really important that we have strong data there. So I think that has gotten us where we are today, which is about 25% share of new patients starts and growing. and really the next leg up of growth is going to come from a bunch of new data sets that we've just put out into the market or have been shared with the marketplace through competitive updates. So on our end, we've seen two really important new pieces of data come out very recently. First, we published an effect that shows a TRUBY actually can have a kidney protective effect in these patients, right? And actually, the mechanism is something we're still working on, and I think we're going to have dedicated studies to actually demonstrate this in a prospective way. But I think that could explain why we see separation on outcomes as early as one month or within weeks of treatment. That's really important. I thinkthat is just starting to be disseminated to the marketplace, and we could see an effect on prescribing behaviors there in the year to come. Second, as I mentioned this morning, real-world data set. I mean, one of the big questions we've had from prescribers that are more on the fence in terms of preference for Atruvi versus anything else has been, okay, I can see scientifically that you've got a much more potent molecule, but it's very difficult for me to compare across clinical studies. They were run in different eras. The population's been shifting rapidly. How do I really know that it's going to deliver a differential outcome for patients? and actually sometimes they ask the patient which medicine they want to be on, which is not great if you ask me. So I think the real-world data set we've published this morning is going to be very impactful in answering that question of does more stabilization truly matter in terms of outcomes? And so, again, what we've seen there is a 34% improvement on the composite of diuretic intensification, CV hospitalizations, and all-cause mortality for Atruvi as compared to defamitis. And again, that effect is seen in weeks, not months or years. So hopefully we can create some urgency to start using Atruvian in new patients or even switch more of your TAF patients onto Atruvy. And there's going to be more to come, right? I think there is, you know, when you see a study coming from a sponsor, there's sometimes appropriate skepticism as to, you Know, the methodology there. But there's an independent real-world data set coming out in, what is it, two weeks or three weeks at HFSA, which hopefully can provide additional validation of what we've published this morning in our study. So, you know, I see Chapter 2 of this launch being driven by some of these newer data sets and leading to really a reacceleration of growth as we look into the second half of next year. That's great. And more data, especially real-World data sets, are very helpful. And so it's great to see, you know, talk, speaking of recent data, a bit of a different mechanism, but, you know, CardioTransform was presented at ESC last month. Just curious, you know, what you think of that data set and how it could be impacting the stabilizer class. I realize it's a silencer, but it was a very impactful presentation last month at ESG. Yeah, and Julie, feel free to chime in here. But I think the, a little feedback here, sorry. I think the most important takeaway from that data set was this whole concept of combining a stabilizer and a knockdown is really without any merit. I mean, we've seen no treatment effect of adding a knock down on top of even a weak stabilizer. And so for the prescribers that were thinking that might be a good idea scientifically and could lead to a good outcome for patients, I think we have just too much evidence today to continue with that. And you saw from multiple major KOLs at the podium say this is practice-changing, meaning that it's no longer an approach that we should be thinking about for our patients. And that really suggests that the frontline backbone of standard of care ought to be a stabilizer. And I think, as we just discussed, all of the data sets coming out here continue to suggest that a TRUBY ought to be your treatment of choice and where you start. It's going to take some time. It's gonna take some effort. It won't happen. We'll have a lot of fighting and repetition and educating the marketplace, but we're optimistic that the data is all on our side and we can continue growing share over the next year and beyond. I think, yeah, well said. The only thing I would add to that is I think one of the other things that clarified is this concept of like, how do you define efficacy in cardiac amyloidosis? And mechanistically speaking, we discuss a lot this concept of the TTR tetramer, and ultimately what's disease-causing is the toxic monomer. And when CardioTransform read out, a lot of folks started digging into what is what we call like mean max efficacy. And when you look at the stabilizers, you have tefamidus. It's about a 60% stabilizer, meaning 40% monomer still forming disease. You have acramidus that's a greater than 90% stabilizers. So less than 10% toxic monomer disease forming. And then when you looked at the knockdowns, it's the inverse, right? It's like, how much do you knock down and then toxic monomers remaining? And we saw that with, you know, with E. plantarism as well as Amvutra, they were in the 60s to 80s, right. So scientifically speaking, I think a lot of dots were connected on an outcomes basis that prior to CardioTransform were more of a theoretical basis. So it's nice for us now to see that narrative evolve. And final point is that even with tefamidus, more is that background therapy in Cardio Transform and still seeing no benefit. Now doctors are also, to Tom's point, taking into account what we've seen with the stabilization data, acramidus being a more complete stabilizer. You now see the real-world evidence. you see the kidney protection data, and it just takes it to the next level, that even with tefamidus, the trial was not successful. With acramidus as the backbone of care, I think it's even further differentiated from the knockdowns. I would say two more things that kind of struck me. We like this topic. Really important from ESE. One, you've continued to see event rates go down with the shifting population, better care. That's really important because I think we can say almost definitively now, a head-to-head study is not possible. So that puts increased importance on real-world data sets like we just reported this morning in terms of providing evidence for treatment decisions. Two, you know, really, I think, related, it means that most of the events happening today are hospitalizations, and so it makes it that much more important to have really, really compelling hospitalization data around your molecule, and we have market-leading data there as well. So 50% reduction in hospitalizations in just 30 months. So I think we're positioned extremely well to continue growing this brand over the next few years to come. It's not going to happen overnight. But with, you know, I think the right team, the right resourcing, and a little bit of luck, you know, I think this can be a massive product for us and a huge impact for patients. Absolutely. Well, you know, just asking a sales question, how should we be thinking about about the quarter-by-quarter dynamics for Chuby sales? Yeah, so I think for the next several quarters, I'd say till we get into really the end of 2027, we'd be thinking about, you know, kind of a 25 to 30 million quarter-on-quarter absolute delta, and that's driven by a few things, really. First would be the dynamic around second line, the Tefaminis switch, so we saw a pretty significant kind of bolus pool of patients early in our launch that were coming off of Tefaminis onto new products, ours and Vujer, the knockdown, which makes sense, right? This was a market where there was one player in town for a long time that was Tefeminis. It was a huge step up in terms of care for patients, but clearly inadequate in terms of the level of efficacy and stabilization. So we knew there was a big pool of patience that were progressing and worsening but had nothing to switch to, so it had just been hanging on to Feminist. So we saw early in our launch, I would say, a larger-than-expected contribution to Faminist switchers. Certainly what we can ascertain from dynamics around the knockdowns is they were benefiting significantly from switch early on in the launch too. And I think at this point we've kind of worked through that initial pool, and that's normalized. So second line is growing, and I would a steady state now which is lower than it was a year ago and so that's one thing that's I think influencing kind of like the near-term quarter-on-quarter dynamics. Two is related which is duration related to patient mix so as I said early in the launch contribution from second line was bigger than we would have expected and that has shifted towards a greater and greater frontline contribution over every quarter since launch to the point where today new starts volume is vast majority is is treatment a frontline share but we're we're dealing with duration from the cohort that came on drug six quarters ago so so that's another thing that I think you should be mindful of as you think about quarter on quarter dynamics near term and then I think you know come wait 2027 all of these new data sets that we've been talking about should begin to get reflected in treatment behavior and and share, and we'll start to see a re-acceleration of sales growth at that point. That's great. In terms, you sort of highlighted, you know, at Truby launch, great data that's just being released just now, the real world studies, and now maybe looking even beyond that, life cycle management. Is there anything you would like to highlight or you're thinking through when you wanna speak to what the potential life cycle management of the drug could be? I'll start. Julie, chime in. I think there's at least three important studies that we're thinking about right now. One is the ACT Early Study, which is the first of its kind. This is a primary prevention study in variant patients where, based on high risk of progression from being asymptomatic to having heart failure based on family history and various other factors, you were randomizing patients to placebo or a TRUBY, and the goal there would be to prevent patients from progressing to heart failure. This is analogous to what we've seen in the statin class with some of those seminal studies there. Practice changing, basically, you know, disease prevention is always kind of the goal if you can figure out a way to do it. So that's key, and I think that also has the effect today of helping drive the narrative around early diagnosis, early intervention, even for patients that do show up to the clinic with heart failure, don't wait, right? Act early. Two, we've just kicked off a cardiac imaging study. The goal there is going to be to show, basically to elaborate and validate a signal that we saw in our phase three study and a sub-study that we had with cardiac imaging. We want to see actual cardiac MRI-based disease reversal. We think it's possible based on the signal we've seen and based on a potency of a Truvi. But I think if we can show that in a prospective study, dedicated study, that again would have the opportunity to be practice changing. And third, as we talked about, we're looking for ways to elaborate on and again validate this renal protective effect that we've seen from our phase three in a dedicated prospective study that really just allows physicians to understand this effect and understand that it is distinct and unique from other approaches that are out there today and really can explain some of the compelling data we've seen on the early separation of outcomes, whether compared to placebo or, again, in a real-world setting, compared to defambas, where you see separation within weeks. Well, before moving on to the next drug, any last comments on that should be? I feel like we haven't had a chance to discuss yet. Anything else? No, I would just say based on new evidence that's emerging across the category, including real-world evidence, seamless execution at the commercial level, differentiated outcomes in terms of science and commercial delivery, we feel more confident than ever in our ability to execute on $4 billion peak or more. I would say one last life cycle thing that I didn't mention is we should have a once daily form coming into the clinic in the next year, 18 months, which, you know, I think there's a minority of prescribers and patients that are choosing to famine is due to once daily forum. But so we want to be able to provide the competitive offering on that front has the, I would say, additional business benefit of giving us a whole new, you know, 20-year patent that should protect exclusivity for many, many years to come. Great. Well, then, you highlighted three other great drugs that are in the process of making their way to patients. Maybe start with the first one, BBP418. Yeah. Maybe, you know, give us an overview of that drug and maybe dive a little deeper and beyond what you gave in your intro. Yeah, so 418 is, will be the first ever therapy for a disease called limb girdle muscular dystrophy type 2IR9. This is, I would say, most phenotypically similar to Becker muscular dystophy where, you know, really bad disease where patients experience loss of ambulation, loss of physical function, around a third experience loss, loss, loss of pulmonary function, cardiac issues. So really bad, progressive disease that is kind of like Chinese water torture is what our patients tell us it's like, where every day there's something you can do less well than you could do the day before, and you're just constantly every day losing function. So really terrible condition, nothing available today. Significant unmet need in terms of prevalence. There's around 2,000, 2,500 patients, we believe, in the U.S. today that have this condition, and another 5,000 or so in Europe, and another 2,000 in Japan with a related condition called Fukuyama muscular dystrophy. 418 is basically targeting the disease directly at its source. So basically the genetics of 2I are basically loss of function, partial loss of funtion in an enzyme called FKRP, which is glycosylating or adding a sugar moiety to a structural protein called alpha-dysruglycan. If you're not adding the sugar, it doesn't function properly. If you destroy FKRP, not getting that sugar, not Getting proper muscle function, and then you get all the symptoms and phenotypes that we see in these patients. So what our drug does is basically provides high levels of a key substrate upstream of FKLP and drives additional flux through the residual enzyme activity that these patients do have to restore that ADG glycosylation. So what we saw in our phase three was basically, you know, our initial approach was to go for kind of a surrogate-based, biopsy-based biomarker kind of approval, accelerated approval, and we developed this very elegant biomarkER assay that actually is able to measure the amount of glycosylation that you're putting on alpha-DG. And we had a phase three that read out one-year endpoint, and we thought we were going to be able to see an improvement in that biopsy-based biomarker and follow the FDA and try and convince them that this was reasonably likely to predict the future clinical benefit. What we were, frankly, blown away to see at 12 months was a profound and consistent impact on every single endpoint we measured in the study. You know, what was to be the confirmatory functional endpoint, which is the North Star Composite, that we saw a stat-sig benefit, an improvement from baseline. FVC, we saw stat- sig benefit improvement from baseline. 10-meter walk tests, we saw stat sig benefit improved from baseline, basically everywhere you look, the patients are getting better, and we've seen a highly stat- benefit from as compared to placebo. So really compelling data set. I think really unique even you know amongst broadly amongst neuromuscular clinical development where you just don't see that many well-controlled, well-designed, placebo-controlled trials deliver this kind of benefit. So we're really excited to get this out into the marketplace and to hopefully change a lot of lives that's great um you know assuming positive outcome with the fda what do you what is sort of your view on the potential for the drug launch and its value proposition yeah uh so just with that the prevalence numbers i just walked you through i mean this is a clear billion dollar plus opportunity in the u.s alone even um and i think there are analogs in similar markets with much weaker data sets suggest price point could be very, very compelling here. I mean, think about the Exxon Skippers for DMD around 700K price point. So I think we're going to have a lot of flexibility to price well. With the FDA, it's been a very constructive dialogue, so expect we'll get approved on or before our November 27th, 2026 PDUFA date. The question there really is will we get full or accelerated approval? And I think, you know, hopeful that we could get a full approval here. And then I think around uptake, so where do we stand today in terms of market building, market development? So today we have around 500 of the 2,000 or 2,500 patients that we think exist in the U.S. identified, confirmed with the correct genotype, and basically mapped to a prescriber. So that's our initial pool of patients that were going to be targeting early days of launch. The way to think about the cadence there is we ought to be able to work through that initial pool of patients within the first three years of launch, so maybe 100 year one, another 200 year two, and then perhaps 300 year three. And at the same time, we'll be growing that pool through all of our marketing efforts out there in the field with our medical affairs and sales force to drive awareness, genotyping, referrals into the centers of excellence where genotyming is standard of care, and really to drive hopefully brought up take over the several years following launch great well before we switch over to 305 any last comments questions as kind of comments on 418 no exciting product I think first of its kind and muster distribute space so really really excited to be out there make big patient impact well then moving switching gears to BBP 305 maybe you could once again Again, give us a nice overview where it stands, you know, and how it looks. Yeah, so this is in Calorin, which is a calcium-sensing receptor for, first indication is a form of genetic hypoparathyroidism where the disease is caused by an activating mutation in the calcium-S receptor. So as we typically like to do, there's a genetic defect, and we like to hit it directly with a small molecule. so this is actually the first indication of a broad set of indications we'll be going after with this molecule including post-surgical or hypoparathyroidism broadly but for ADH1 this is a again a high emit need where patients actually you know there's a case report that just came out of England, I think, following a family where two of the children in the family actually died in their 30s from some of the terrible symptoms, heart failure and just general tendon seizures. So it is a very serious condition. If you talk to specialists that treat this, that treat hypoparathyroidism, their ADH1 patients are usually their most difficult to manage where they see very low serum calcium driving all the symptoms, they try to manage it with supplements which just makes the elevated urinary calcium that much worse, and it's basically creating a ticking time down the path of renal destruction. So the need here was for a therapy that could basically fix the aberrant signaling in the calcium-sensing receptor and hopefully alleviate the low blood calcium and the high urinary potassium. And so what we saw in phase three was in six months of therapy, we were able to completely withdraw conventional therapy, which is calcium supplements and vitamin D, and put more than 75% of our patient population into the normal range on both of those aspects, urine and blood calcium. Incredibly compelling, that's a functional cure for more than three quarters of our study population. More than 90% had parathyroid hormone into the norm range almost instantly. And so really, really profound effect in this population, which is incredibly exciting for this population that desperately needs care. So excited to get out there in the marketplace. Again, this is similar to limb girdle 2i. This is a condition where there's nothing really available. There's no sponsor out there marketing driving awareness, so that's on us to do. We're out there today with field medical and sales leadership of working on driving urgency to test. Here, it's a dominant condition, so meaning families that have this condition have about 50% chance of passing it on, so family testing has actually been incredibly helpful here. We actually have a mobile testing lab van that we bring to advocacy and family events, and actually it's been surprisingly productive to date, So we'll keep driving that along with more conventional, I would say, market development tactics. That product has a May 8th PDUFA date, so under FDA review. And I think the overlooked aspect of the calendar is actually the expansion opportunity into a broader suite of hypoparathyroidism conditions, including the biggest bucket, which is post-surgical hyperparathyroidism where we've just kicked off a phase three pivotal study. Those are first patients there in the next couple of weeks. That could add, I would say, a couple billion in opportunity to this product. And we'll enroll this study next year and hopefully read it out late next year. It's early 2028. So large expansion opportunity on the horizon there. That's great. Well, then, last but not least, the last drug you highlighted earlier, infragratinib. I'd love to hear, you know, your overview there, what you're thinking in terms of long-term perspective of that drug. Yeah, absolutely. So similar to what you heard Tom say about our other molecules, so infogratinib also directly targets the mechanism of the condition at its source, the genetic mutation for FGFR3, whereas some of the other products in the market today are more indirect treatment mechanisms. So scientifically speaking, we feel very good about mechanism. As many of you know about the achondroplasia space, so there are two treatments available available today, CNP analog products that have really shaped the market and provided an option where nothing was available today. What we feel very encouraged about, starting with the U.S., when you look at the market, severely under-penetrated, so only about 20 to 30 percent of families have opted into treatment today, and that's due to some very, very good reasons. The first is that the only currently available products are injections, whether that be a a daily injection or a weekly injection, very, very difficult and limiting for families. Second is that this community has been very vocal that they want to see benefits beyond height, right? So we want to seek benefits on complications, functionality, comorbidities of the condition. And infagratinib is the first product to show statistical significant benefit within 52 weeks on benefits beyond height, so specifically proportionality. So not only did we demonstrate that largest annualized height velocity across the category, but it's these benefits beyond height that are really meaningful for physicians and the community. So just two weeks ago at Espe, we also released new data. Previously we had shared in the primary data readout as well as our New England Journal manuscript the height velocity and the proportionality data, but we just also included data on otitis media, which ear infections, as well with sleep apnea. two common and difficult complications of this condition. Also within 52 weeks, infogratinib demonstrated benefit on both of those outcomes, the only product to do soar. So as we are preparing for launch here in the U.S., there's really three distinct categories for source of business. The first is that large portion of the market that has not opted for treatment today that we believe an oral therapy that demonstrates benefit beyond height can unlock. The second source of business is those who are on an injectable therapy but might be seeking more in terms of convenience and efficacy that's being left on the table. And the third category of source of business are those who were previously treated and have discontinued. Our evidence points resonate well across all three categories. Go-to-market in the U.S., we have our medical team sized and deployed facilitating scientific exchange today. We're building out our commercial infrastructure to really call on where we know patients are being managed and families are seeking care today, as well as where some families who are not seeking care today are interacting with mostly their primary care. So we have a team that's ready to educate and inform the community so that they are ready to make an informed choice about therapy. XUS, it's a very different environment. So ex-US treatment penetration is much higher. It's only about 20 to 30 percent in the U.S. Outside of the U-S, it's more 7 to 80 percent. So we've created a global international commercial organization that has developed a bespoke go-to-market model based on country. So, we've looked at all the primary markets across Europe, Latin America, Asia Pacific, and we've been able to design a commercial infrastructure kind of ranging on one end of spectrum from a direct presence the other end of the spectrum to more the distributor or partner market strategy each unique market we've been able to design our commercial infrastructure to maximize rate of speed uptake as well as price potential it's all about demonstrating value in these markets and we feel we have the clinical evidence to do so as well as the medical team and the commercial team to support the launch that's excellent and a Really nice overview of the key programs in your company. In the last minute here, any last things you'd like to share about BridgeBio before we wrap it up? Yeah, no, I mean, I think 2027 really is going to be a transformative year for the company where we're going to go from one product, R&D, you know, excellence in the last year to four products launched globally. And I think when the time is right, There's a huge amount of pipeline we could bring back in to develop a very unique and generational integrated biopharmaceutical company that can do a lot of good in this world. So yeah, I think it's a tremendously exciting 18 months to come and hopefully beyond that as well for many, many years. Excellent. Well, thank you both for your time today. It was great to discuss the company together. Thank you. Thank you, sir.

...