BridgeBio Pharma, Inc. ($BBIO)

Good afternoon. I will be your conference operator today. [Operator Instructions] Before we begin, I would like to remind everyone that today's call may contain forward-looking statements within the meaning of the federal securities laws, including, but not limited to, statements about BridgeBio's future operating and financial performance, business plans and prospects and strategy. These statements are based on current expectations and assumptions that are subject to risks and uncertainties, which could cause actual results to differ materially from those expressed or implied in these forward-looking statements. For a discussion of these risks and uncertainties, please refer to the disclosure in today's earnings release in BridgeBio's periodic reports and SEC filings. All statements made here are based on information available to BridgeBio as of today, and the company undertakes no obligation to update any forward-looking statements made during this call, except as required by law. With that completed, BridgeBio, you may begin your conference.

Good afternoon, everyone, and thank you for joining BridgeBio Pharma's First Quarter 2026 Earnings Call. I'm Chinmay Shukla, Senior Vice President, Strategic Finance. With me are Neil Kumar, our CEO; Matt Outten, our Chief Commercial Officer; and Tom Trimarchi, our President and Chief Financial Officer. On today's call, Neil will walk through our commercial pipeline and business updates with Matt providing additional promotion detail and Tom covering financials. Following our prepared remarks, we will open the call for questions. For the Q&A session, we will be joined by Ananth Sridhar, Anna Wade and Justin To, who will lead our programs with encaleret, BBP-418 and in sorafenib, respectively. With that, I'll turn it over to Neil.

Thanks, Chinmay, and thanks, everyone, for joining us today. As always, this is a form in which we communicate sale and aspects of our business center of interest to investors, and we welcome your questions and feedback along the way. I want to spend the bulk of my time today talking about 3 things. The first is the Attruby franchise, and I want to talk about our continued commercial momentum there and how we think about clinical differentiation. Importantly, these 2 things plus the economics associated with the RD orphan drug channel underpin our confidence that Attruby will continue to grow even past 2032. The second thing I want to discuss is launch readiness against the 3 exciting first-in-class or best-in-class brands we have in AV H1, LGMD2I and achondroplasia. Although there are no major near-term clinical catalysts for any of these brands, there is a tremendous amount of activity going towards ensuring expeditious and high-quality approvals and launches. In its history, BridgeBio is demonstrated across now 3 approved products with hopefully 3 more to come, the ability to take on post Phase III regulatory submission activities at very high quality, and we intend to build on the tradition for these new brands. I'll end my comments by addressing the current gap between our intrinsic value and where our shares trade today. I've heard from investors in the past that too much NPV talk. It's not what people tune into these calls to hear. But at this point, it is my responsibility to discuss matters related to capturing the value that investors who have been in our stock for a long time have helped create. Our focus on BridgeBio has always been a long-term value creation and on reliably being able to take in money to do more work over time. And by the way, our activities across the BridgeBio ecosystem show that there are many more of these R&D opportunities out there. but this model is reliant on capturing the value of the work for investors, which is why today, I'll be discussing a share buyback program that will commence immediately. Let me begin my comments by talking about Attruby. As many of you have read in the press release, we've had 186 -- we've got $180.6 million sales in U.S. Attruby net product revenue this quarter, which represents a 24% growth from the last quarter and a 392% growth year-on-year and is consistent with the brand globally becoming a blockbuster in 2026. Our focus continues to be on winning in the front line, where we believe the 95% stabilizer that preserves the native tetramer is not only the optimal solution but even against combinations is the only solution 1 you start with as it provides the highest degree of management of TTR monitor deposition provides impact more quickly and is consistent -- which is consistent with the pharmacokinetics of TTR stabilization and ultimately achieves all of this in a cost-efficient and easy-to-access manner. Trenthetically, our data suggests a tripling in combo use with Attruby with the various knockdowns, suggesting that the message that once you reach for a better stabilizer even in combination is resonating. As it relates to the front line, our major competition continues to be Poser and our best understanding of our share is that it has grown from the NBRx share I quoted at the JPM to even further more, but still remains behind what Poser has been able to accomplish in the front line. We believe that in this quarter, total new patient starts in the category were in excess of 6,100 new patients, and we believe that for the first time, we are convincingly the second brand by volume in this space. There's more work to be done, but all of these trends continue to be in the right direction for us. So how do we port some gasoline on these growing sales? The obvious way to do that in normalized is through clinical differentiation. We began to see reasonable inclines in the second derivative of our growth as the serum TTR story began to evolve in the marketplace with multiple papers adjusting the iron levels of serum TTR associated with lower levels of mortality at 30 months. As a reminder, every made per deciliter of incremental increase in serum TTR seems to lead to a 5% decrease in mortality risk at 30 months, meaning a more potent stabilizer and we do not hear from any physicians equivalent with the fact that Attruby is a more potent stabilizer it is, should lead to better outcomes for the patients that we serve. Building on that, we are now beginning to explore and are confident in the outperformance of acoramidis versus diamides in the real-world setting. There were only really 2 real-world evidence studies reported to date, survival studies done in Colombia and by Dr. Masri that showed outperformance of acoramidis both but those were comparing our trial data and not at that point -- we didn't have enough time at that point to be in the market long enough to demonstrate anything in the plastic real-world evidence setting. That is now changing. At SCAI, an independent wheel world evidence study presented by the Valley Health System of Nevada revealed statistically significant outcome improvements associated with acoramidis as compared to tafamidis. Building on this, we have a study in Med Archive that we will publish shortly in a major journal, showing that Attruby reduces diabetic intensification by 43% as compared to tafamidis. We intend to continue studying and publishing on Attruby's differentiation in the real-world setting and are glad to see the cardiology community doing so independently. Interestingly, 1 of the benefits of acoramidis that was identified in the independent real-world evidence study was a lower incidence of acute kidney injury. As I mentioned in my JPMorgan talk, we are driving towards what we believe will be a seminal publication with potential impact for patients, physicians and even on our label as it discusses an observed rapid hemodynamically mediated renal protective effect, which is unique to Attruby as opposed to the other stabilizers and knockdowns in the space. We continue to present and publish on a parameters and major medical meetings as well. At ACC recently, we've presented long-term efficacy and safety data from our Phase III open-label extension showing sustained clinical benefit from acoramidis at Monty 54, including a remarkable statistically significant risk reduction of 45% in all cost mortality with a p-value of less than 0.0001 and a 49% reduction in cardiovascular mortality, again with a similar fee value versus placebo tuspamidis or acoramidis. All right. I'd like to turn to the rest of the pipeline now. On LGMD2I as I alluded to in my earlier comments, our team was able to go from top line unit to NDA submission in 155 days, consistent with our ethos at every many counts and the fast pace that we have previously set with regard to our TTR regulatory submissions. We continue to work closely with the agency and foreign regulators to bring this medicine as expeditiously as possible to the patients who need it. I had the opportunity to attend the top line result presentation recently in Orlando at the FDA meeting. It was a trip I won't soon forget. I was struck by the excitement that our data generated, not only within the LGMD2I community, but more broadly, given the striking results associated with BBP 418 suggests that functional improvement is possible when targeting well-described conditions at their source. Given the already 500 or so genetically confirmed patients in the United States today, the highly engaged patient community and physician education being conducted by the team, all of this augurs well for a positive launch dynamic. Moving to ADH1, I'll be leaving from here to a very similar gathering on top line presentation of our calibrate Phase III data at the European Congress of Endocrinology in just a matter of days. Here again, we'll be looking to drive segment the broader physician community and to educate the patient community and establish a base of data that together with our publication of our Phase II data can ensure the market building exercises can continue with high fidelity. Importantly, BridgeBio has been supporting via grant family genetic testing events in the United States that continue to identify new patients with relatively high yield, although we have been launching at a time when a vast majority of patients with ADH1 have not been identified yet. The combo and genetic testing, ICD 10 cos and broad disease awareness education such our belief that we will be able to find ever more patients in need of this compelling drug products. Furthermore, our Phase III and choice thyroidism will be commencing this summer and is bolstered by a recent published work that illuminates the central role of the calcium sensing is after in the kidney plays in regulating calcium metabolism. Finally, moving to achondroplasia. The results from this trial came after LGMD2I and ADH1, but I suspect given the strength of the results prominence of the condition and the remarkable KOLs we're privileged to partner with that the Phase III manuscript will be forthcoming in a major medical publication, and we anticipate presenting the full PROPEL 3 data set and a medical conference in the second half of 2026. Early commercial research shares suggest unaided awareness in excess of 40% from this the prescribing physician community, which for those of you who are commercialized know is a very high starting point and certainly higher than what we've seen before in our own portfolio. Finally, I want to touch on the share repurchase program that we announced today. To do so, I'd like to go back to BridgeBio's founding principles. The company was built on a few things to help as many patients as possible and to establish a corporate and financial model that creates and captures value in predictable responsible ways. That value capture has always been part of the mission when we talk about NPV, while we anchor to intrinsic value while we try to make the right economic decision at every part. The reason for that is because of the capture value, more capital flows into drug development over time and more patients get served by us and others employing our decentralized diversified model. Unfortunately, at this moment, we have not adequately captured value for the investors we serve given the large distinct between our NPV per share and our firm's intrinsic value. Even with the revision of Vinda Max's entry from 2035 to mid-2031 or early 2032, our in intrinsic value remains markedly higher than where we've been able to get the shares to trade to today for investors. To that end, the Board has authorized a $500 million share repurchase program. These repurchases should allow our shareholders to concentrate their ownership in our portfolio whose risk profile has fundamentally improved. Of note, we have employed this technique in the past some 6x. In aggregate, even accounting for the free part day buyback, we have driven substantial returns for investors with our share repurchases. While we have this lever, we still believe in putting capital into our launches and advancing our clinical trials, repurchases are additive and opportunistic, not substitutive and are a direct result of our strong balance sheet. On the balance sheet point, we will always size deployment such that we preserve full flexibility to finance every critical program and activity in our portfolio. Plenty of liquidity and the ability to easily service our liabilities is a requirement before we deploy dollars into the buyback. Okay. With that, I'll turn the call over to Matt to talk more about our commercial leverage.

Thank you, Neil, and good afternoon, everyone. Q1 was another strong quarter for Attruby, delivering an impressive a 24% increase in net sales from Q4 and a 392% year-over-year increase from Q1 2025. Growth was driven by our existing and expanded sales teams, accelerating new patient starts and first-line share gains. There are several factors which contributed to these results. Market momentum has remained strong new-to-brand market share hit its fastest quarter-over-quarter growth since Q1 2025 and first-line patients have increased each and every month of the launch. Fill rates, cap rates gross to net, compliance and persistency all continued to remain in line with expectations. Insurance reauthorization dynamics has been a topic of industry discussion this quarter, and I want to address them directly. Attruby did not experience reauthorization disruptions for 2 reasons. Part D as in David is a continuous plan-based model, which avoids the annual renewal friction of Part B as in Boy. That structural advantage matters. In addition, in 2025, the average co-pay for Attruby patients was only $190 for the entire year, making many patients pay only $0 out pocket as well. Our field teams executed with exceptional discipline to keep patients on therapy with valve interruption. We hire exceptional people and those people make sure that any patient who wants a near complete stabilizer can get a truly and importantly, and stay on Attruby. Turning to our pipeline. We are encouraged by early indicators across our 3 anticipated near-term launches in LGMD2IR9 ADH1 and achondroplasia. In LGMD2IR9, we are entering a disease area where no approved therapy exists. We've onboarded a commercial leadership team and have set up a specialized patient identification and field reimbursement infrastructure. Our goal is simple, to find every patient who can benefit and be ready to serve them from day 1 of approval. In ADH1, our claims analysis has already identified nearly 2,000 patients in the U.S., and that number continues to grow. We've built a dedicated sales leadership team and patient infrastructure tailored to this community. Encaleret would be the first medication to target the disease mechanism directly and it's orally administrated Position excitement is high, and we are ready to move immediately at approval. In achondroplasia, we are preparing for a global launch with a truly differentiated clinical profile infigratinib is the first medication to demonstrate statistically significant improvement in body proportionality, not just improvements in average high velocity and the only oral auction in the category. For family seeking an alternative to injectables or returning to treatment after a negative experience, the clinical profile and route of administration of infigratinib is very compelling. To summarize, Q1 continues to reflect a durable growth trajectory for Attruby and proof of the commercial capability we've built at BridgeBio, an organization that knows how to launch, scale and build franchises. We remain focused on execution for patients, for families, for prescribers and for long-term value creation. I'll now turn the call over to Tom.

Thank you, Matt, and good afternoon, everyone. I'll now walk through our financial results for the first quarter of 2026. Our commentary will focus on GAAP financials unless otherwise noted. Total revenues for the first quarter of 2026 were $194.5 million compared to $116.6 million for the same period in 2025. The $77.9 million increase was primarily driven by a $143.9 million increase in Attruby net product revenue. Attruby product revenue in the quarter was $180.6 million compared to $36.7 million the same period last year. Royalty revenue increased by $9.3 million to $9.5 million, primarily earned from net product sales of Bandra in Europe and Japan. License and services revenue was $4.4 million compared to $79.7 million for the same great last year. The decline reflects the recognition of onetime $75 million regulatory milestone for the prior year. Total operating expenses for the first quarter of 2026 were $290.5 million compared to $218.4 million for the same period last year. The $72.1 million increase reflects deliberate and disciplined investment in Attruby and preparations for our 3 upcoming launches. SG&A expenses were $163.9 million an increase of $57.5 million compared to the same period last year, reflecting measured investment in our core activities. R&D expenses were $126.6 million an increase of $15.2 million driven by investments in medical affairs and CMC in support of our next launches. Turning to the operating line. In the first quarter, we recorded a $106 million operating loss. For the last 5 quarters, our loss from operations has narrowed by more than 50% due to OpEx discipline here with strong execution on Attruby. Looking at the quarterly trend, if we back out onetime milestone payments, we've seen an improvement in the operating line every quarter since it truly launch. Looking ahead, we expect the trend new loss from operations to flat over the next 2 quarters as we ramp up launch trading activities for the next few products and continue narrowing towards the end of this year to 2027, we transitioned to a P&L breakeven followed by cash flow positivity, which we expect to be sustainable for that going on. Turning to the balance sheet. We ended the first quarter with $940.2 million in cash, cash equivalents and marketable securities compared to $587.5 million at the end of last year. We believe our current cash position provides us with significant runway to fund our operating activities advance our programs for the approval launch and continue to invest in truly portion growth, all while maintaining financial discipline we demonstrated to date. With that, I'll turn the call back over to Chinmay.

Thank you, Neil, Matt and Tom. Operator, please open the line for questions now.

[Operator Instructions] Our first question comes from the line of Tyler Van Buren with TD Cowen.

Hello. This is Sam on for Tyler. And congrats on another strong quarter. I was just wondering, can you guys talk about what's driving the continued Attruby acceleration and specifically what you're seeing in those treatment-naive patients?

This is Matt. I'll take that one, and thanks for the question. We're definitely excited about the continued performance of Attruby. I think the acceleration you're referring to is being driven by a few things. The first is physicians' desire to use the only near-complete stabilizer on the market. Stabilization is the backbone therapy in ATTR-CM and near complete stabilization along with the truly speed and showing separation from placebo is attractive to patients and HCPs. They want something that's going to work quickly and it truly has shown that it can do that. And recently, as you heard from Neil in his original remarks, the real-world evidence has backed all of these points up for both the treatment naive patients and switch patients, and that's helping to drive our share upwards.

Yes. Maybe the only thing I'd add there is the serum TTR story, I think you saw a bevy of papers both from us, but then importantly from others, using the numbers that I put forth the projector increase associated with pretty remarkable decreases in mortality, downstream. And obviously, as a reminder, when we put patients on a Ramatis following administration of tafamidis coming out of our Phase III trial, you saw 3.4 per deciliter increase and everyone increased their serum TTR level. So it doesn't really matter how you measure it. You're just getting increases in serum TTR. And the question outstanding was never, I don't know, Matt, if you'd agree with this, whether or not at amass a better stabilized or I think most people can understand that even if they can't understand a specific in vitro assay. And the bigger question was how much more is that buying me in terms of downstream results and these TTR work was just the first part of that you're going to see a lot more of that in the coming 12 to 24 months really just because we have enough patients now with not duration that we can start to ask and answer those questions.

Our next question comes from the line of Mani Foroohar Leerink Partners.

Congrats on the results. In the aftermath, the tafamidis IP evolution and some clarity on genericization of gas, not of acoramidis. Walk us through operationally how you think about the development and commercial strategy for revenue in the 2031, '32 and beyond.

Mani, thanks for the question. So the clarity on Redman's idea is clearly a meaningful positive for Bridge and Attruby. We now have at least 6 years of runway before generics, which is more than enough time to reach peak share. And obviously, this all materially reduces any tail risk we will have to the NPD program. I don't think the resolution really changes our commercial strategy. We've always been focused on establishing a true the treatment of choice in RCM, given its differentiated profile, and we're executing against that. I think you heard both Neil and Matt talk about the value of literature that we are producing as well as all the commercial activities which we are undertaking to really reinforce that differentiation and drive share. I guess what I'll say at the end is just -- we've shared our belief that Attruby will be a $4 billion drug last year in our Q1 25 earnings call, I don't think you've ever been more confident in that estimate. I actually think if anything, there might be some room for potential upside. I think as Neil mentioned in his prepared remarks, Attruby likely to keep growing even after 2032, given the ecosystem and channel dynamics that exist here with Part B. And so that's kind of what's driving our confidence. So yes, I think it's working for us. We've reduced the area on our valuation.

Yes, maybe I'll add to that. I mean, I personally did think Mani and we talked about it that it would be 2035. So obviously, I was wrong on that. That is a little bit of a discount, but not material, as I mentioned in my comments, and the bigger thing is like all of these differentiating studies that we're running, it is really starting to resonate with clinicians in addition to the fact that the access programs are superior. So I guess what your question is really alluding to is like will we run a double line head-to-head. We still might Were the option to do that. Certainly, we've been excited to do that in the context of either TTR levels or NT-proBNP. But how we size like a hospitalization study is difficult if you look at the number of events. We're going to have a strong look at the placebo arm of the upcoming poison trial to really understand what those event rates look like in the context of clinical trials to see if there are some double-blind headed opportunities. But there's nothing obvious right now. So let's continue on the real even studies, which I think are the best honestly, characterization of sort of differential competitive dynamics.

Our next question comes from the line of Biren Amin with Piper Sandler.

Can you walk us through the Board's decision to authorize the $500 million share repurchase program and how you're thinking about balancing that against your investment in new launches and pipeline? And I guess what, if any considerations are there for additional business strategic initiatives with this share repurchase program now being announced.

I'll tick that off. I mean I think right now, the focus is on focused execution against the pipeline that we have right now. We've got in discussions with investors ample growth that has not been valued in the context of this company to date. I mean the LGMD2I launch that I referred to, the AH launch, the AECOM launch even as totality, I think we're projecting market share numbers well in excess of what typically a third mover gets in that space. And then you think about the consequential additional indications, both in terms of hypo and importantly, in terms of chronic hyperthyroidism that we're kicking off. And then we've got the Canada program. So that constellation of activities is more than enough to drive long-term growth for any company, and that's kind of what we're focused on. Can we fully finance all of that comfortably, and we feel like we can. And therefore, beyond that, what all we do with excess capital and we think the best relative in terms of relative return way that we can deploy capital right now is into our own chairs just given the disconnect between intrinsic value and where we're trading. So that's really what the discussion came down to. It's hard to -- I know the normal way that biotech will grow and say, well, who carries share price is low, let's go ahead and dilute everyone and just keep going after science that we believe in. But that is not a reliable, sustainable long-term model in my belief, and nor is the 1 that we intend to employ here at BridgeBio.

Our next question comes from the line of Cory Kasimov with Evercore ISI.

Great to see all the ongoing progress. So I want to follow up on this real-world evidence that was referenced in both the press release and the prepared comments that reinforces Attruby's differentiation versus TAF. Can you kind of unpack what this real-world data that you're seeing, how it compares with what was demonstrated in the clinical trial setting? Is anything different now than it was or just more of it?

Yes, it's pretty different because recall that we had a significant less shift in our clinical trial, like those placebo outperformed the on-drug arm of ATTRACT. There's kind of no way for us to actually apple-apple go across like diuretic kind of case. Oh, and by the way, like even the use of diuresis and [indiscernible] and SGLT2s and so all of that stuff has changed pretty markedly. So it almost made it impossible accepting the in-trial comparisons we can make between tafamidis and acoramidis with all of the available caveats there, where, just as a reminder, acoramidis just outperformed examines in all aspects, which you did not see in HELIOS. But I think real will levies the right way to do this within systems or across a constellation of systems that we know have a lot of integrity in terms of clinical studies. And here, you're seeing things like what we mentioned in terms of diabetic intensification, we certainly didn't look at the downstream kidney effects like the Nevada system did, but it's all resident, I suppose with the advantages that we think Attruby has versus amis in terms of mortality and hospitalization. It's just nice to see actually play out in the real world.

Our next question comes from the line of Salim Syed with Mizuho.

Congrats on another great quarter. Just 1 from us maybe on infigratinib and PROPEL 3. So since you guys have had that read, I'm sure you must have done some market share work or at least spoken to additional folks in the Aecon community, both on the clinician side and family. So just curious what the feedback has been there? How the additional feedback informed your expectations for the commercial opportunity. I believe you said previously you sort of think about AECON being a $2.5 billion TAM and maybe hypocon, the same. Just curious if you have any other color there to offer on the commercial opportunity.

Yes. Good question, Syed. I think the feedback to the credit here hears me overall only positive. HCPs are telling us that they're constantly being a family when the oral is coming, both on families are on treatment today, but more importantly, those that stayed on the sidelines, which as a reminder, makes up out 70% to 80% of the U.S. market. The consistent best-in-class profile is continuing to resonate with the clinicians. They understand that AHP is best in class, the IT scores best in class. We have the most attractive safety profile and importantly, on proportionality right? Personality data point is the 1 that's resonating most the clinicians because this is the only product that has that day result in portionality, in a 3 to 8 age group population, and which is a demonstration of how directly targeting FGFR3 impacts more than just higher is about health. And on that note, we will be releasing more data on how infigratinib benefiting more than just hike in medical homes later this year, some of which has been seen before in 52 weeks geocontrolled pilots there. ultimately, all this is to show that it really reinforces our belief that we will have a peak market share actually more than 60% market share as valued by our market research here.

Our next question comes from the line of Ellie Merle with Barclays.

Two from me. First on limb-girdle. So you submitted the limb-girdle very quickly. So our math about 150 days from top line, which is a very fast compared to average. Can you walk us through where you stand on readiness and how you're preparing to get this drug into the hands of the limb-girdle community from day 1? And then a second question on the ATR space. How are you thinking about what we will see from cardio transform specifically prostate and the trial is very well powered, but what's the hazard ratio that you think could be competitive? And how are you thinking about that?

limb-girdle, this is Tom. So I'm going to pass, so I'm going to Anna Wade here and then [indiscernible] to be able, first of all, to say I'm really proud of our team for the quick turnaround on the NDA, and you expect that level of efficiency from the next 2 as well. But over to Anna, and [indiscernible].

Thanks for the question, Ellie, and thanks for the kind words, Tom. So yes, we're really excited. We have our commercial and sellership on board. We're getting ready to have the sale for higher at least this year. We also now have our medical leadership in place as well as the seasoned MSL team with neuromuscular and Reese experience. In Q1, our major catalyst is the NDA conference, as Neil mentioned, in March, where [indiscernible], a leading KOL and Cal presented our Phase III and term analysis data. And we have incredibly positive feedback at the meeting about the Impella package. Since NDA, we've heard about significant patient outreach to neuromuscul and intendedly we have received many inbound inquiries from both patients and physicians. Abacus right now is driving wins at the Phase III data as well as emphasizing the importance of genetic diagnostics leveraging responsive testing programs that are currently available. So that they want at lunch, we can be ready to get patient about the therapy.

I think let me address your second question there, he was on the cardio transform. Yes, we agree with you. It's a super well-powered trial. I mean, obviously, against the primary it was good and even in the subpopulation. Like if you take the same point estimate from Helios B on combo and you just think disease for and then you say how many more patients would you need like 2.5x more to hit a p-value 0.05 or less and they're pretty well powered for that. So I actually expect that they'll hit on almost everything that they're in carrying and so then it comes back to how do I cross [indiscernible]. how do I understand this? [indiscernible] technology, part of that will be how much knockdown they get and are they able to improve on the PK profile because I think the reason that Pat performed similarly to Ambua or in the HELIOS-B trial has to do with the timing it takes for good to get to me match knockdown. So take a lot longer than I would have expected. So we'll see if that's the case with their drug. I think overall, obviously, cardio transform has more to do with the commercial dynamics without Mylan than it does with us, especially given the combo data that I just told you about it. I think people are going to reach for stabilizer first line anyway, number one. Number two, I think when they're failing stabilizers, they're going to want a better stabilizer on board in combination. So if that come alarm does hit, I don't see it having a meaningful -- super meaningful effect for us. Again, I mean, from a biochemical standpoint, you always want to preserve the native tetramer. We're seeing more and more information about that. I'm surprised people haven't been looking at the publicly available fares database and what do things look like when you're knocking things down versus actually stabilizing and all consistent with the 2 25,000-plus patient studies that we've seen out there suggested a higher level of better for you, but I understand that in a short trial, those signals aren't necessarily resolvable. But I think over a longer period of time, stabilizers will continue to be frontline and in combination. I think we'll have a we'll have a pretty good start. But that's kind of -- that's how we're thinking about it. We do think Cardiopet will be positive, just given the patient numbers. On your hazard ratio question, I mean, obviously, we think the bar is relative risk reduction of 42% and risk reduction of 50% upon hospitalization, which I suspect if this study is consistent with the rest of the modern studies are going to be a vast majority of the events will be hospitalization, not mortality. So I think that far 50% reduction in holding is kind of what I'll be looking for.

Our next question comes from the line of Anupam Rama with JPMorgan.

Congrats on the quarter. Quick on [indiscernible] 1 here. I know the NT NDA is on track here for the first half of this year. And then the press release highlighted nearly 2,000 now identified identifiable patients with ICD-10 code. Can you give us an update about further patient identification efforts? And how this sets up how we should all be thinking about the initial launch curve?

[indiscernible]. Yes. So I would say that the foundation of everything that we're doing around Visia identification is really awareness, awareness of the disease that's an important distinct subset within hypopara. And then, of course, awareness of our driving power and a wonderful effect can have for these patients. I think a major catalyst for awareness is going to be the upcoming presentation that you see next week followed by U.S. presentations later in the year and then hopefully a very high impact obligation as well. But in the background, I think there is some important tactics and strategy that we continue to employ. First, as you mentioned, IC 10 code is a huge advantage to us here. Many rare diseases don't have an ID in golf. They have 1 that's been in place for a couple of years already. So there's a good amount of data in that lets us take our analytics capabilities, put them on top of this and really deploy our field-based medical and commercial leadership in a more surgical way to go to the offices spread awareness and also make sure that the patients they think they have appropriately diagnosed with our sponsor genetic tests, whether commercially double genetic tests. And then third, and I think this has been a bigger driver of identification that I would have thought is just family tracing, makes sense when you consider this isonomic conditions. So there's a 50% chance of passing on. So when we tend to find 1 person with this condition. If they look in good to a family event, we find out that many of them, in brothers, cousins, antidotal site conditions. So that's been a real valuable source of patient identification as well. So we'll continue all these efforts and accelerate them as we approach launch.

Our next question comes from the line of Derek Archila with Wells Fargo.

congrats on the progress. Just a follow-up on infigratinib. Some recent commentary on some of the early KPIs from the UV well launch seem positive and maybe early validation of kind of this market expansion pieces. So just curious how you think about infigratinib's profile versus the injectables and how this could further accelerate this market expansion potential?

Yes. Thanks, Derek. I think post not physicians and families are set about the total package of the grain, right, not just 1 thing. It starts with a 2.1-centimeter change of baseline HP, the largest effects shown across any of the I which was remarkable we use across the age groups. That, of course, has meant earlier, we always attempt on personality, a demonstration of the importance to directly engaging [indiscernible]. And then you have a differentiated safety profile, right, with no injection site reactions, no symptomatic extension, no hepatosis. And I think the safety differentiation is further playing out given the increasing and concerning signals of SKIPPY and demarcates which are both looking like potential Conplast. That go on top of this for us is being the daily oral. Based on historical benchmarks, we know that when oral enters a only injectables, it expands the market on average by 3 to 4x at [indiscernible] after launch. So ultimately, the pot here will have a choice of either 365 injections a year, but the 2 injections a year or 0, and I know which 1 not [indiscernible].

Our next question comes from the line of Paul Choi with Goldman Sachs.

Sticking with the infigratinib, I want to ask with regard to the PROPEL infant and toddler study in patients who are newborns are up to 2 years old. Can you comment on your updated thoughts on enrollment timing and when that might potentially be completed in the wake of your positive results from the PROPEL study and just how you think about timing for that potentially being completed and being added to the label?

Yes. Thanks for the question, Paul. Definitely, I think there's a lot of expansion from sites and proponents in the Phase III AI data just kind of -- what we know from the field showed that earlier intervening more likely your impact likely to impact clinical outlooks. I think we've seen that be averse there. So we'll provide an update on timing and probably later on once we have some more clarity on this program progresses.

Our next question comes from the line of Andrew Tsai with Jefferies.

Congrats on execution. I have a bigger extra question for you guys on your broader pipeline. Now that you have succeeded across 4 major programs all the way through Phase III. As investors think about the sustainability of your R&D engine, maybe talk about how you're currently thinking about the next wave of development beyond your portfolio? And how much you're open to adding more to the pipeline in the near term? And what indication areas you could be interested in?

Yes. Thanks for the question. I think right now, as I think a lot of our comments and actions have been consistent with, we're very focused on executing the opportunity in front of us. It's not often in a biotech will launch, 3 different products and 3 different indication setting alongside a pretty competitive market. at the same time. And that's going to take certainly against our lean back on all of the focus that we have I also mentioned earlier that we have pretty significant additional opportunities associated with leveraging 1 of our drug products, including some that we haven't talked about vis-a-vis Attruby. So I actually think that there's some pretty interesting stuff to do. We have an internal pipeline, obviously, prosecuting programs in ADPKD, leading cardiomyopathy and in delete antibody program in ATTR cardiomyopathy. So that's additionally programs that are very, very capitally efficient but programs that we have an eye on today. And then we bought back our programs against all of our current pipeline programs so that we can do what's right for the patient and physician community to continue to serve that as long as possible. So all those things put together, I would say, represent the menu of activities that we're interested in, in the near term. Obviously, we're students of the genetic disease space. BridgeBio has a significant stake in another company called Bandola Bio, which is really kind of 1 of our sister companies, and that has 17 programs. I think we've gone through ranging from Phase all the way back to the preclinical setting and a very, very exciting slate of small molecules, ASOs, antibodies, all targeting well-described genetic conditions at their source. And so I would say that we're happy for that to be sort of an off-balance sheet R&D exercise for now as is BridgeBio oncology therapeutics and really to focus on what we need to focus on here. which is continued prosecution of our pipeline programs and delivery of these important medicines to patients and ultimately, the capturing of the value that we have created for the investors and in fact just for many years.

Our next question comes from the line of Danielle Brill with Truist.

Congrats on the great quarter. Neil, I believe you mentioned in your prepared remarks that there were 6,100 new patient starts across the class in the quarter. As I recall, correctly, this represents a pretty meaningful step-up from prior quarters where I think it was more in the 4,000 new patients range. Just curious what's driving the step up here? And moving forward, how should we think about the size of the quarterly patient pool that you're actively competing for?

Yes, sure. I mean I think this market continues to grow somewhere between like, I think our internal numbers are somewhere between 5,000 and 6,000 in that range. a quarter in terms of the new patient starts or new patients to brands. So actually, I don't think we have 4,500 for the last quarter. I think it was about $5,000. But a little bit of this math has to do with like us guessing for our competitors, what the inventory hold that was or what the inventory buys were and things of that nature. So can never get it only [indiscernible] obviously, our own base number is fully right. But that does suggest continued growth. I mean will it continue to grow? I think so. Obviously, there's 250,000 patients with cardiomyopathy at the low end in the U.S., and I think we're doing a better job with 3 things. One is making sure that the algorithms are in EMR so that people think they look for these patients. there's all the tracer AI stuff that we've been doing, other algorithms that we make a little health care systems have been pointing for us to just get people that think maybe this is a TTR patients. That's one. Something that's driving genetic testing into variant heavy populations, that's been helpful as well. And there, probably the best is just broad traditional awareness and education through speaker bureaus really getting out into the capitated practices of the community practices to educate them more. So all of that is positive. I'd say on the negative side, we've heard quite a bit about this PYP shortage that technician can 1 of the ways that you can do the scans to get debt a definitive diagnosis or [indiscernible]. So that we have to keep an eye on. We've heard about that before. Like in 2025, we heard about that, I think, in the second or third quarter. So 1 of the new quarters and end market continue to grow. But what's keeping eye on that. That's resolvable. There's 3 major suppliers of that. And I think I expect in the years going forward, we shouldn't see much more of this sort of supply chain iteration around IP availability. Yes, long story short, I believe that you should see -- like I think Evercore put out a nice analysis of this 3, 3 years ago or so was like you should see simple linear growth in identification given the number of patients that we believe have HTL cardiomyopathy coupled with the number of sponsors in the playing field and the availability of reasonable testing. I would expect that trend -- that positive trend can continue with some errors quarter-to-quarter.

Our next question comes from the line of Jason Zemansky with Bank of America.

Congrats on the great progress. Maybe 1 more on Encaleret if we may. As you look beyond the ADH1 opportunities, sort of the broader chronic hypoparathyroidism opportunity. How are you thinking about in encaleret positioning, I guess, relative to the parathyroid hormone replacement therapies. Is there a particularly attractive subgroup to target? Or are you looking at sort of the broader opportunity as a whole? And then maybe if you could talk about some of the pricing implications of pursuing a market that maybe looks a little bit like 25,000 patients in the U.S. and EU versus 200,000?

Jason, it's great to hear from you, and thank you for the question. We look forward to seeing you next week at the conference. So in terms of encaleret in chronic hypoparathyroidism, when we did our market research, it's really 3 things which drove our excitement about the opportunity. The first is that this will be the first oral option available in this chronic setting. And so the ability to give patients freedom from injection-type reactions and all the pain that comes with it, it's something that resonates very well, I would say. The second thing is, if you look at the current options available, use an effect in terms of vortalcium normalization, but you don't really see that effect on during calcium normalization. And I think with encaleret, we have a very unique profile where we could normalize potentially both blood and calcium and we saw that in our all small Phase II trial, where we had around 80% of the patients modalizing both blood and urine calcium. And these are patients who are very sick and did not have the at our plan or any amount of the hormone. And then really the third thing is that there is any potential safety risk in terms of board resorption from giving PDH at high levels for the word. And so I think we would completely avoid that. And I think actually, we get on read out significantly [indiscernible] profile for encaleret. And so I think that those 3 things or urine causing normalization and potential benefit on safety is really why we think we can compete and get a reasonable share even in the chronic agitate market, obviously, assuming that the trial works.

Our next question comes from the line of Sean Laaman with Morgan Stanley.

This is Morgan on for Sean. Can you just remind us specifically for infigratinib and achondroplasia, what kind of, if any, commercial preparations are taking place from BridgeBio?

Thanks for the question. I think we've done a lot to build strong commercial and medical leadership here, right, bringing on for both sides of the business experience in both set in the tire market with superior to data, especially with experience at [indiscernible]. We've also had a lot of experience with being groups with scale this play experience as well. Ultimately, I think right now, we're trying to make sure and we get the word out, not just leading in edited AMC, but also to a broader kind of new pediatric endocrinologists who are really excited about having an oral option, especially for validate if they're not seeing how the super specialized centers of care, more interested in happening, something that's easier for family minister as well. So a lot of exploration going on that front.

I think to remember we have a lot of the teams in place from the Attruby launch that can also help with the future launches for all of the indications. Think about market access with the payers, the pharmacies, these are all the same individuals, and we have relationships with all those people and are able to launch quickly, I think, as a result of that and get access and coverage.

Our next question comes from the line of John Boyle with William Blair.

Congrats on a strong quarter. So patient advocacy groups for achondroplasia seem to have a pretty big voice in the indication. So wondering if you had any interactions with them and if you could speak to how the integration profile is resonating there?

Yes, thanks for the question. I think that's been a core tenet of how we can develop the drug since ever. We've been working alongside acute groups, both United States and internationally on making sure that their input and voice is implemented in our development burden and how we think employs. And for us, being able to target FGFR3 directly, address the concerns of being able to look at not just height outcomes but health at as well, which is something we expect to play out in the longer strand of full extension program. And I think the really wonderful partners with us, and we anticipate that persisting through commercialization and launch as well.

Thank you. And ladies and gentlemen, that concludes our Q&A session. I will now turn the call back over to the BridgeBio team for closing remarks.

Thank you, everyone, for your questions today. We really appreciate your interest and look forward to updating you again next quarter.

Ladies and gentlemen, that concludes our conference call. You may now disconnect your lines. Have a pleasant day.