Okay, good morning, and thank you for joining us on day two of the 47th annual Goldman Sachs Global Healthcare Conference. I'm Paul Choi, and I cover the Smithcat biotech sector here at the firm. It's my pleasure to host the BridgeBio management team, but before we get started, I'm required to make certain disclosures. These disclosures relate to investment banking and other relationships that Goldman Sachs may have with the firm's companies discussed today. These disclosures are available to you as clients of the firm on the research portal. We are prepared to read them aloud, but they are available on our research portal. But otherwise, after that, I'd like to welcome Bridge Bio here. To my immediate left is Tom Tremarki, CFO. Next to him, Chime Shukla, SVP of Strategic Finance. Anna Wade with the neuromuscular business. And we're also, last but not least at the end, Julie Miller Everett, who runs largely a true business here, among other responsibilities here in the U.S. So maybe what we'll do is kick it off with Tom and maybe talk about what are BridgeBio's strategic priorities for the remainder of this year and going into 2027, and then we'll get into Q&A.
Sure. Yeah, well, thank you so much for having us, Paul. Wonderful to be with you in Miami once again. I would start by saying it's an incredibly exciting and energizing moment to be at BridgeBio. We're transitioning from a single product company with the Truby, which is continuing to show strong momentum and uptake in the first-line setting, which I'm sure we'll spend plenty of time talking about, transitioning to a for-product commercial business, global footprint. And I think one thing that's getting missed by Wall Street is really what that can do to the top line in the 27, 28, 29, and beyond timeframe. I think really just a unique growth profile enabled by that. And so our priorities today are to continue demonstrating with the Truby that we have a differentiated product, so we're 25% a share, north of 25% share of treatment-naive today and growing. We're also seeing good use in second-line setting, which is also important for patients because if they've not been well-managed on a first line, they need to get on a more potent stabilizer. And so our priority on that front is to continue driving that story, driving differentiation. We do it with data. We do it by being persistent out in the field. We do it with strong marketing messages that you've seen so far. Second, third, fourth priorities are to file our NDAs for the next product, get approved on time with great labels, and launch well. And hopefully we can spend plenty of time talking about BBP418 for Limb Girdle, thanks for having Anna here, and actually Infragratinib, which Julie is now mainly focused on. I meant to say skeletal dysplasia. Yeah, skeletal dysplasia is business. So really, if I step back and put all those things together, priorities are to continue delivering on a Truby and to continue scaling up to be really, I think, a generational and special multiproduct partner and commercial organization serving the rare community.
Maybe since it's top of mind with investors, let's start maybe with the ATTR market. It's been evolved in the last year from a single player in terms of Pfizer with Tefamidus to a multiplayer market in the past few quarters. And I think one of the key things investors are focusing on is, sort of what is the rate of market growth, how many more patients are being identified, and how has this changed versus, let's say, a year-plus ago when tefamidus was the only available option for patients?
Yeah, Paul, happy to take that one. So we're incredibly pleased to see the strong growth of the ATTRCM market. Maybe I'll just break about the market into the two segments, first line and second line. On the first line side or the treatment-naive side, you know, before we launched, we were saying that there are about 2,000 to 3,000 patients diagnosed every quarter in the U.S. Today, there are 3,000 to 4,000, probably closer to 4,000 than 3,000, if I'm being honest, new patients diagnosed every quarter starting therapy in ATTRCM. So, of course, that's a remarkable amount of growth in just a year. We're not seeing any slowdown. I think that we have heard a little bit of rumors about PIP tracer shortage, but so far it seems like being able to work through it, at least on the Atrubi side. What's also extremely encouraging to us is our treatment-naive share has continued to go up, and every single month of the launch, we have received more treatment-naive patients than the previous month. That really has been the engine which has propelled the Atrubi launch. It's been the key driver behind our momentum. Now let me turn for a second to the second-line treatment market, which is a very important market, too, here, right? So these are patients who are on tefamidus, which is a partial stabilizer and who have been progressing and then get put on either mono or true B, mono Ambucha, or a combination approach. And here what we have seen, you know, this market tends to be a bit more volatile quarter to quarter, but, you know, we continue to see strong, steady growth. I do think that Q425 and Q126, the switch market, was a little elevated than usual because Vindiquel was being pulled from the market, which allowed more potential switches. For us, I would say we split this market roughly 50-50 with the other players. And what we've also been very encouraged to see in the second-line setting is that our combo use has tripled from Q425 to Q126. And I think that's really because physicians are recognizing that the most important thing that you can do for your patient is to first put them on a near-complete stabilizer. And I think with all the data that's been generated on a TRUBI as well as the strong label, we've had a lot of receptivity to that message. So that's kind of how we're seeing both the overall growth as well as the two subgroups grow.
Okay, great. Can you maybe speak to where you're seeing the most utilization of a Truby? Is it more academic centers or centers, hospitals, heart failure centers of excellence versus community prescribers? Are you seeing preference for, you know, one modality or approach? And is that what is driving your NIRX share or Nudibrand share?
Yeah, happy to talk about all of that. So we have seen really strong, broad-based growth in a Truby amongst all HCP segments. So academic medical centers, high-volume heart failure clinics, regional academic centers, community doctors. We've seen strong growth throughout. I think one thing which we've been excited about is that we've been able to unlock a lot of high-volume heart failure practices. You know, a couple of key reasons for that, right? The first reason is that we have a safe oral small molecule, which is what these physicians are used to prescribing. The second key reason is the fact that we've been able to generate really strong data on our Truby. Now, I would like to highlight specifically a couple of pieces of data which have been generated, right? The first is, you know, 40 to 50% of ATTRCM patients have some component of AFib, and these patients are traditionally considered to be difficult to manage patients, and a TRUBI we've shown that is able to reduce AFib-related events by 43%, which is, you know, the strongest data that any agent in this space has been able to show. So we've been able to go out and educate physicians on this data. That has given them a lot of confidence to keep the patient in their practice and just put them on a Truby as opposed to refer them out somewhere else. That's been a big driver for us. I think another big driver for us has been the fact that we have very, very strong variant data. We're the only agent which has shown a static effect on proportionality, on hospitalization and mortality. We've been static on so many different things across our programs that I sometimes confuse it, so apologies for that. But static on mortality and hospitalization in the variant subpopulation with the strongest hazard ratio, which has been seen to date in this category, right? And that's also a segment which is extremely underserved today. And as we build on this with real-world evidence and other pieces of literature, I think our strength is only going to get amplified. So those are some of the things which have driven the impact more than other kind of things that we have done. But the growth really has been quite broad-based, which is encouraging.
As we think about where the stock is, I think probably one of the things that's top of mind with investors is how to think about maybe the intermediate-term outlook for the Truby franchise once the Tefaminis generics become available following the recent use of the settlement. And so I guess from your perspective, Have you seen any, you know, first, changes in the field in terms of physician behavior now that this news has sort of become more public and they know 2031 to 2032 will be the sort of launch timeline for a generic? And then second, with this revised timeline versus sort of what Pfizer had previously been guiding, you know, how are you thinking about the growth outlook as Truby and the ATTR market evolves in the early to mid-2030s?
Yeah, so we haven't seen any changes from physicians in terms of prescribing behaviors or anything like that, and that's to be expected. You know, the potential genericization is still almost five years away, probably a little more than that away in terms of the price actually coming down. So we've seen no changes on that front. And in terms of our own perspective, of course, we agree with you that the settlement was a bit of an upside, right, because I think initially everyone had assumed that the brand goes away in 20, the Windermax brand goes away in 28. Now I think it's at least here until mid-2031, more likely until early 32, and more generics can actually come in. So that's been a bit of an upside. For a Truby, though, it doesn't change anything. We've always maintained that Truby is a differentiated molecule that starts with the label. It's the only near-complete stabilizer. It's the only stabilizer which works as quickly as one month. Those elements of differentiation really are the core driver of the strength of the molecule today and in the future. In terms of how we think about it sort of in the intermediate term, I don't think that, you know, Vindamax genetics are going to have any meaningful impact on a TRUBI. I think that by the time this event happens, a TRUBI will be at peak share both in terms of patients and likely also in terms of revenue. There's no defined marker of progression in this disease, so it's very hard to kind of forcibly switch patients, especially given the fact that the molecule is differentiated. So I don't think that we expect to see any impact from that. We were, you know, encouraged because it reduced the error bars of our NPV and it took out some tail risk, so we felt good about where things landed. And then the last thing which I would say is actually something that investors have told me. I see some of the ones who have told me here in this room. So, you know, when you look at other markets like this, right, the prostate cancer market is one which frequently gets brought up to us. When the first-to-market goes genetic, you know, the differentiated second-to-market molecule does not have any impact on its sales. In fact, its sales continue to go up. So that's kind of what we expect to see here, and so we continue to build on that. You're talking about the Zytiga X-Sandy analogy here, right?
Great. Great. Maybe just a couple more, and then we'll bring Ana and Julie into the conversation. First, where is the market in terms of combination therapy penetration based on your field research? And what pushback, if any, are you seeing from insurers on this for either combined use with your drug or competitors' drugs?
Yes. So maybe I can take that and add on here. So what we're seeing today is fairly low rate of combination use in the second-line setting. We're not hearing really any use in the first-line setting. And as Jim, I mentioned, although we're not primarily out there with message around combination use, our story around differentiation is leading to growth in this segment, which may continue to grow, by the way. So we're positioned well in case that does happen. And I would say, from an insurance standpoint, certainly the commercial plans are trying to manage that and avoid that. But for Medicare, right now, it seems not to be much of an issue at all. I don't know if you'd add anything to that. No, I think that that's well said.
I guess, sorry, the one thing which I would add is the combination is not recommended by guidelines, which I think is a key point. So there's no real benefit of combination, which has been shown thus far. I do expect CardioTransform will change that, but that's a weak stabilizer and a weak knockdown, so it's a little different, and so that's just a few more ones to keep in mind there.
That's right. We have a limited subset from the Helios B study, at least currently undergirding combination use, but on the subject of CardioTransform, I think this is the other thing that's top of mind with investors in this category, at least over the near term, and if the study is positive, which I think is sort of the consensus expectation, the real question being what does the combination arm look like given that it will be a more substantial portion of patients versus Helios B, how does that affect the market dynamic post the potential approval of that combination regimen or therapy for ATTR-CM?
Yeah, so happy to talk about that. So I think we agree with you that the study, including all the subgroups, including the combo, are, you know, likely to be static and positive given the size of the trial and also given the fact that you're using a weak stabilizer in the background so it's, you know, possible to show these kinds of effects. So that's kind of our expectation. That's always been our expectation and when we have said that a true B peak share will be between 30 to 40%, it considers a four-player market with this kind of properties for a plot person. I think that the way this will evolve is combo could be used by more physicians. But again, I think the physicians are going to recognize, as they already do recognize, that you want to start the patient on the best stabilizer and then put them on the best knockdown also. And so I think our job is to win the argument to be the best stabilizer. That's kind of where we're focused on. And so I do think that it's not really going to affect a Truby in any meaningful way. I think it's going to make physicians realize that the more you are able to reduce the toxic monomer, the better you do, and that helps a Truby. As a scientific matter, I'm personally very keen to see some of the relative risk reduction. I think we were able to see a 50% reduction in hospitalization at 30 months. We were also able to see a one-month time to separation on heart outcomes. I'm curious to see what this trial is able to show for the other agents. I think that's going to be informative. And then the last thing which I'm, again, scientifically interested is just on the safety side, because there have now been many studies which talk about the long-term safety aspects of having the tetramer around. Here you're going to see this in a larger population of knocking down the tetramer. So what effects do they have? Let us see that. and some of that also then pertains to the AFib data and other things that we've seen in Helios-B. So those are some of the things that I'm scientifically interested in, but commercially I don't really think it's going to affect a Truby in any way. I think the two stabilizers will compete with each other and the two knockdowns are going to compete with each other. Just a high level to add,
the reminder that this is primarily a second-line study. We think the impact on the market is going to be felt primarily in the second-line setting, certainly over the next several years, which is an important and growing segment of the market but much smaller relative to the opportunity in Treatment IE Frontline where we continue to focus our resources and continue to see nice share growth.
Tom, you began earlier with talking about your late-stage pipeline and NDAs that you're planning to file. Yes, maybe at a high level, can you maybe explain to the audience why you think each of these assets could be blockbuster opportunities in and of themselves?
Okay, we have 18 minutes left, So I'm going to monologue on that question. No, I mean, it's a great question. So, I mean, I make a few general statements that are consistent across the three. These are three areas where you've got a tremendous unmet medical need. So in the case of limb girdle or ADH1, there is literally no medicine today, a population that is experiencing serious debilitating symptoms or, as we'll get to, I'm sure, limb girdle, consistent decline of function over time. So there's a real need there. in the case of infagratinib and achondroplasia, we have a couple of approved agents, but I think there's a huge unmet need still to address some of the burdens of injecting small children, but importantly, to really deliver in a more meaningful way on efficacy in the way we have with our phase three data. So first of all, there's a huge unmet need for us to solve. Second, these are all three conditions that, while they're considered rare and orphan, are on the higher end, I would say, in terms of epi. You've got, you know, about 2,000 for limb girdle in the U.S. alone. You've got probably 3,000 to 4,000 in ADH1 diagnosed today, potentially up to 10,000, 12,000 in the U.S. And infogratinib, you've got 3,000 to 4,000 actionable children in the U.S. All of these have also expansion indications that we're looking at to grow the opportunity for us. And so when I put that together with the unmet need and I put that together with the likely ability to price very competitively here, given the overall value proposition, I think it is a clear path to meaningful peak year sales for all three of these products.
Great. Anna, maybe on the subject of limb girdle, can you maybe help us understand, you know, how many patients are being, you know, actively tracked based on claims data here, and how does that stand relative to the prevalence pool that Tom was just talking about?
Yeah, absolutely. So, as Tom mentioned, we estimate there are around 2,000 patients in the U.S. with limb girdle musculotistry type 2I. Currently, we have around just over 500 genetically confirmed patients that we currently are tracking, and then we currently have ongoing efforts on patient finding, so that is leveraging the data and analytics that supported the Atrubi launch, as well as sort of deep account profiling with the field teams currently, and we anticipate here that there is a very engaged patient community already, so the phase three trial actually over-enrolled by around 20% and also eight months early, so we know that there as a very engaged patient pool. And I think we really anticipate that that 500 is going to grow relatively quickly. This week, actually, there is a patient conference that is the patient conference in the U.S. this weekend called the Wellstone Conference. And there we are doing, we have a strong presence, and we are educating on three key things. So one is, obviously, genetically diagnosing patients. So what is your genetic subtype? The second piece is ICD-10 code. So a new ICD-10 code came in last October. We are seeing that being taken up right now, but we're really encouraging patients to go into their physicians and getting coded correctly to the specific ICD-10 code to the subtype. And then thirdly, ensuring that patients are engaged with their physicians so that really on day one of launch, everyone is sort of the patient community is ready for a potential available therapy.
You mentioned earlier genetic identification of some patients, but broadly, how is this in terms of either U.S. or European or other sort of clinical guidelines for identifying patients? Is this something that just becomes emergent as the child gets older, or are there sort of active guidelines from MDA and other relevant societies here?
Good question. So basically, in the neuromuscular space, patients can be quite nonspecific. Sorry, symptoms are quite nonspecific. So basically, genetic diagnosis is pretty common. is a step in the diagnostic pathway. At limb girdle, 2I is included in most of these neuromuscular panels, or actually all of the neuromuscular panels. So as long as patients are getting into that stream, they will be getting genetically confirmed. I'd say right now it is definitely standard of care to be genetically diagnosing patients within these specialized care centers. So in the U.S., there are around 150 MDA centers, which would be driving a lot of the diagnoses. but we are trying to educate to actually increase that outside of just the specialized care centers. So, yeah, I'd say it's a standard of care to be genetically diagnosing right now.
I think when Wall Street saw the BBP418 data, it was a surprise to the upside. I think that's fair to say. But can you maybe share what physicians or KOLs have said in sort of the MD muscular dystrophy community on the data? Specifically, what are they focusing most on? Is it distroglycans, any other particular measure, and what has stood out most to KOLs that you might think drive adoption here in the future?
Yeah, absolutely. So we presented our data at the NCA conference in March, and it was incredibly well received. So I'd say overall the entire data package is overwhelmingly positive and very consistent and is pretty much unprecedented in the neuromuscular space. So typically what people are expecting here is you have a progressive decline, and people are hoping to sort of slow decline. And what we're actually seeing is improvement from baseline and then decline in placebo consistent with the natural history, which is pretty much, like, unheard of. And so we saw that across all of the primary and secondary endpoints in the interim analysis, as well as across all subgroups. So it's not even being driven by just one particular sort of subsegment of the population. It's actually seen across all patients that are in the study. And we're seeing that across the biomarkers, as you mentioned, So there's glycosylated alpha-distroglycene, CK, which is a marker of muscle breakdown. But we're also seeing it across the functional outcomes, so breathing and walking, which is pretty much – which is really incredible. So the KOLs at the conference and since and also in just HCPs we've spoken to are really kind of blown away by the data. If you ask a HCP in the space sort of what would you want to see in a theoretical TPP, they actually just don't even describe something that is as good as what we're seeing. and it is anticipated to be driving sort of high adoption rates across really all eligible patients. So, yeah, I think overall it's been very, very positive. And since the data has been published, we've been hearing from centers that there has been significant patient outreach.
So I had the pleasure of attending MGA with the team. I can tell you it was easily the most important data at the conference. And really just to step back and put it in perspective, you have a well-designed, well-controlled trial. that delivered stat-sig on every endpoint and not only significant effect versus placebo, an improvement from baseline on drug is just something that these prescribers, families, patients have never seen in the muscular dystrophy space full stop. And so to say there's excitement is a large understatement, I would say.
Given what you've just said, what analogy or guidance would you provide to the street in terms of what the launch trajectory might look like? As we as analysts think about things like in the DMD space or SMA space, do you anticipate a bolus? And then how quick is that bolus if there is one? And does it become growth more based on the incidence of rate of patients? Or are you thinking about more penetration of the prevalence pool over the near to intermediate?
Yeah, maybe I can say a couple lines and then pass it on to Anna to add more colors. So we are incredibly excited about the data, and we are extremely excited about the launch. I think just as a reminder, Purdue for here is towards the end of November, so we're actually going to very, very quickly come up to that. The program is also eligible for a priority review voucher, which, of course, also has some monetary value to it, so just wanted to make sure that was on everyone's radar. In terms of the launch, we expect a very strong launch. I think that it's not going to be a bullish-driven launch. It's going to be more of a sustained long-term launch, And I think that the initial target is going to be the 500 or so patients that Anna mentioned we are tracking. So it's going to take us some time to penetrate into those. And then while that's going on, we're going to be trying to expand that base and grow it out further from there. So I think that's kind of what I would say in terms of that. And, you know, it's a little too early for us to provide super specific analogs or guidance. But look for us to do that, you know, in a month or two once we sharpen our pencils on that. But, Dana, I don't know if you want to add anything.
So, yeah, basically I agree. I think there's going to be a strong, sustained launch here. We mentioned that there is this, like, very engaged patient community, and we know where a lot of physicians and patients are because they have these concentrated – they're concentrated at the MDA centers in the U.S. I think the sort of what's tempering maybe sort of an incredibly fast sort of bolus-type launch would be that typically these patients are going into their positions maybe once or twice a year. And so really we are trying to drive urgency to treat, but that's something that I think the physicians, like that's more of a change in clinical practice than right now. So typically right now physicians are seeing their patients about once a year. So to change that dynamic will take probably a little bit longer.
Julie, one of the things I think investors are trying to figure out
is sort of what the U.S. market dynamic look like versus the ex-U.S. market dynamic. Historically, we know about three-quarters of Biomarens Voxoco sales have come from the ex-US markets. And so as you think about infant gratinib, more steady state down the road, how does that U.S. versus ex-US split look like for bridge biome? Great question.
So I think for us, we anticipate it being a little bit more even moving forward between U.S. and ex-US. And part of that, if you take a look at the U.S. market specifically, We know that there's about 3,400 patients that are eligible, pediatric patients eligible with open epithesis for therapy. And what we know with Voxogo is that the product profile of Voxogo has really maximized its potential in terms of treatment penetration in the U.S. today as a daily injectable. We believe there's about 700 patients on therapy out of that 3,400. We firmly believe that infagratinum has the potential to grow the treated population in the United States. At launch, we're going to be looking at three key patient segments. So first and most importantly, it's those that are not on treatment today. There's a variety of reasons. It could be that the benefits that Voxogo showed were not in line with their treatment goals. This is what we're so excited about. Chinmay actually said it earlier because he's so excited about it, is our STAT-SIG proportionality. We are the first product to demonstrate statistical significant proportionality benefit within a placebo-controlled study in 52 weeks. So we show benefits beyond height, which can help us unlock those who have chosen no treatment Our second segment is those who have potentially tried Voxogo but stopped. And then our third segment is those who are currently on Voxogo. We do believe that we will see uptake within all three segments in the United States. But similar to what Anna just said, looking at the practice dynamics in the U.S., we're also coming in to see their treater about one to two times per year. So really we anticipate a wonderful launch through the first couple of years here with a very high peak. I think we've said to you before, Paul, we think it's about $2 billion peak global sales eventually, and we do believe about split evenly between U.S. and ex-U.S., which is a different dynamic.
Just on that sort of $2 billion aspirational peak sales or goal for peak sales, is that inclusive of hypochondroplasia or is that just achondroplasia?
That's just achondroplasia. Yes, so that's just our primary indication. I'm glad you brought that up. So we do have a very rigorous life cycle plan for the molecule, which we actually started hypochondroplasia in the works right now. And it's funny you'll hear me say, as many of you I spoke to, I was a Truby lead for a long time and recently have moved to take all that learning and apply it now to infagratinib. But one of the things that we learned a lot when we were launching a Truby was that being second to market also has its advantages because you can deeply interrogate everything that the first to market product did learn from their experience. We are actually really excited to see now Biomarin go out and build the hypochondroplasia market so that when we launch a more convenient option, we'll be able to leverage all those learnings from the achondroplasia launch that's upcoming and apply that to the hypochondroplasia space as well.
I think investors are generally comfortable with the notion of an oral therapy versus a daily or even a weekly injectable probably likely to perform in terms of market share. But on the subject of hypochondroplasia, Julie, We saw numerical outperformance from Vesoratide based on their recent top-line data. Do you expect sort of a similar result here for Infragratinib as you prosecute this indication or opportunity, and maybe just how do you think about the data that might be coming out in terms of your pending update?
Maybe I'll take a couple minutes, and then I'll pass it on to Julie to add more color. So, Paul, just to set the stage on this, so obviously incredibly excited, as Julie was mentioning to see the bio-marine data. I think that it's going to help us, you know, it's going to make sure that there is a market built, which we can then penetrate and do really well. So that's been a big source of excitement for us. We have seen a lot of excitement in our HypoCon study. Recall, we enrolled this trial even before Propel 3 read out, and it enrolled extremely quickly, significantly ahead of our expectations. Just as a reminder, the team actually has come up with a very innovative clinical design. It's a seamless phase-two phase 3 trials, so once we find the right dose in phase 2, we can immediately start the baseline portion of the phase 3 and not waste any time in terms of getting this important medication to the children who really deserve it. Currently, we're in the phase 2 portion. We're testing two doses, the ACON phase 3 dose and a dose lower than that, so I think we're going to have an update on what that looks like sometime this year in the second half. I do think that, you know, ACON and HYPOCON are caused by different mutations, and so it's going to be key for us to find the right dose here, and we will make sure we optimize that, similar to how we did in the ACON phase two study back in 2023. And so, you know, that might involve actually going upper dose also. So we're exploring all of that, just coming from our clinical development team as well as KOLs, given the safety profile which we showed in Propel 3, we didn't know that when we started the study. So that's kind of where we are at right now, and I think, you know, work's ongoing. But Julie, do you want to talk more about how convenience is going to be a big factor in HypoCon and how we're looking to just see StatTig here as the bar?
Yeah, absolutely. So as we all know, there's a large portion of the achondroplasia market that is not able to handle injections, and it's definitely not preferred. All the market research points to that being even furthermore the case in the hypochondroplasia population because it tends to be a slightly attenuated symptomatology. So we do believe that the oral option will be even more strongly preferred in the hypochondroplasia space as opposed to achon.
Maybe last one, just both for as it applies to limb girdle and achondroplasia. Can you maybe talk about how you're going to or what you have in place already in terms of your ex-U.S. commercial infrastructure, how much, you know, is going to be direct versus partner or distributor programs for your two assets here?
I love this question. So we are very excited to launch this outside of the U.S. So we have built a very appropriate infrastructure. So really what's beautiful about the achondroplasia market, and this is different from our first asset, right, from Acromitus where we did partner this, is that the medical home, the treatment home is very centralized in Europe and other parts of the world. So you're able to launch this asset with a very highly targeted specialized team that's much, much easier to do than if you're looking at a broader, like, cardiology space product. So we've hired the right people. We've looked at, like, a regional structure with also country-specific resources. And to your very specific question about doing it ourselves versus partnering with, like, a distributor model, we're taking it on a region-by-region, country-by-country basis. But right now we have the people, the process, the systems, and the asset to do this on our own.
And I guess just to add to that, so for LimGoodle, we're going to leverage whatever is getting built out for InfoGraphNib. But our timelines are a bit more uncertain. So, as a reminder, our strategy here was accelerated approval in the U.S., but because we saw such profound and incredible benefits at the interim analysis, we're now targeting a traditional approval in the U.S. this year with the PDUFA in November. With the EU, we're currently engaging regulators there to see what our timeline could look like to really bring in our European timeline. So, our European launch is a little bit more uncertain, yeah.
I know we're almost out of time, but I will just say very briefly, too, that what we're really focusing on is bringing on the right team. So we're hiring people who have launched either other skeletal dysplasia products globally or other rare disease products globally or those who have launched second or third to market products and very quickly cannibalized the existing market. So we're putting the right global leaders in place for outside of the U.S.
Great. We're coming up on time, and so I want to maybe ask one more for Tom here to close out, which is you recently announced a share repurchase program. You haven't necessarily utilized all of it yet, of course, but just sort of basically think about the opportunities internally versus repurchasing your stock. How did that decision come about?
Yeah, great question. So I would start by saying with every dollar is to fund the business so we can grow and reach patients in the right way. So nothing gets done on the repurchase side if that's not taken care of, and we feel very comfortable with the level of resourcing and the balance sheet today to take care of all of that. I would say, you know, just a bit about the rationale there. So we feel our job is to create value by making drugs that matter for patients. I think we've done a fantastic job doing that. A Truby is out there growing. Next three, we're very confident are going to be important products out in the marketplace. Beyond that, we think given where we are as a firm, given where we see the P&L shaping up over the next year or two, we wanted to have access to an additional tool to capture value when we see an opportunity. And just quite frankly, like when we see the stock go $65 a share, there's an opportunity to capture some value. So we wanted to have access to that tool when the time is right in a disciplined and intelligent way.
Thanks, Tom, and thanks to the BridgeBio team for joining us. We'll end it on that note. Thank you, Paul. Thank you, Paul.