Good afternoon, I will be your conference operator today. All lines have been placed in me to prevent any background noise. After the company's remarks, there will be a question-and-answer session. If you would like to ask a question, please press star followed by the number one on your telephone keypad. And if you would like to withdraw your question, press star when again. Thank you. 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 Law, including but not limited to statements about Breach Bios' future operating and financial performance, business plans and prospects, and strategies. These statements are based on current expectations and assumptions that are subject to risk and uncertainty, which could cause actual results to differ materially from those expressed or implied in this forward-looking statement. For a discussion of this risk and uncertainty, please refer to the disclosure in today's earnings release and Breach Bios periodic reports and SEC filing. All statements made here are based on information available to BridgeVio 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, BridgeVio, you may begin your conference.

Good afternoon, everyone, and thank you for joining BridgeVio Parma's first quarter 2026 earnings call. I'm Chinmay Shukla, Senior Vice President, Strategic Finance. With me are Neil Kumar, our CEO, Matt Alton, our Chief Commercial Officer, and Tom Tramarki, our President and Chief Financial Officer. On today's call, Neil will walk through our commercial pipeline and business updates, with Matt providing additional commercial detail and Tom covering financials. Following our prepared remarks, we will open the calls for questions. For the Q&A session, we will be joined by Anand Schreeder, Anna Wade, and Justin Toe, who will lead our programs with NCALITIC, BVP418, and Ensogratinib, respectively. With that, I'll turn it over to Neil.

Thanks, Jimmy, and thanks, everyone, for joining us today. As always, this is a forum in which we communicate salient aspects of our business that are 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 three things. The first is the Atruvi franchise, and I want to talk about our continued commercial momentum there and how we think about clinical differentiation. Importantly, these two things, plus the economics associated with the Part D orphan drug channel, underpin our confidence that Atruvi will continue to grow even past 2032. The second thing I want to discuss is launch readiness against the three exciting first-in-class or best-in-class brands we have in ADH1, 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 toward ensuring expeditious and high-quality approvals and launches. In its history, Rich Vial has demonstrated across now three approved products, with hopefully three more to come, the ability to take on post-Phase 3 regulatory submission activities at very high quality. And we intend to build on this tradition with 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 is 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 at Bridge Bio has always been on 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 Atrube. As many of you have read in the press release, we've had $180.6 million of Atrube sales in U.S. Atrube 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 a 95% stabilizer that preserves the native tetramer is not only the optimal solution, but even against combinations is the only solution one should start with, as it provides the highest degree of management of CTR monomer deposition, provides impact more quickly and is consistent which is consistent with the pharmacokinetics of tpr stabilization and ultimately achieves all of this in a cost-efficient and easy to access manner parenthetically our data suggests a trickling in combo use with the truby with the various knockdowns suggesting that the message that one should reach for a better stabilizer even in combination is resonating as it relates to the front line our major competition continues to be Pfizer, and our best understanding of our share is that it has grown from the MBRX share I quoted at the JPM talk of 25% even furthermore, but still remains behind what Pfizer has been able to accomplish in the front line. We believe that in this quarter, total new patients starts in the category where 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 be done but all of these trends continue to be in the right direction for us so how do we pour some gasoline on these growing sales the obvious way to do that in our mind is through clinical differentiation we began to see reasonable inclines in the second derivative of our growth as serum as the serum ttr story began to evolve in the marketplace with multiple papers suggesting the higher levels of serum ttr associated with lower levels of mortality at 30 months as a reminder every mg 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 many physicians quibbling with the fact that Truby 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 acroamidus versus decaminus in the real-world setting. There were only really two real-world evidence studies reported to date, survival studies done in Colombia and by Dr. Mazri that showed outperformance of acoramidus 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 classic real-world evidence setting. That is now changing. At FCAI, an independent real-world evidence study presented by the Valley Health System of Nevada, revealed statistically significant outcome improvements associated with acoramitus as compared to defamitus. Building on this, we have a study in MedArchive that we will publish shortly in a major journal showing that Atrube reduces diuretic intensification by 43% as compared to defamitus. We intend to continue studying and publishing on Atrube's differentiation in the real-world setting and are glad to see the cardiology community doing so independently. Interestingly, one of the benefits of acoramitus that was identified in the independent real world evidence study was a lower incidence of acute kidney injury as i mentioned in my jp morgan talk we are driving toward what we believe will be a seminal publication with potential impact for patients physicians and even on our label as it discusses if an observed rapid hemodynamically mediated renal protective effect which is unique to a truby as opposed to the other stabilizers and knockdowns in the space we continue to present and publish on acroamitus and major medical meetings as well at ACC recently we presented long-term efficacy and safety data from our phase three open label extension showing sustained clinical benefit from acroamitus at month 54 including a remarkable statistically significant risk reduction of 45 percent in all-cause mortality with a p-value of less than 0.0001 and a 49 percent reduction in cardiovascular mortality again with a similar p-value versus placebo to spaminis or to apparatus uh 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 data to nda submission in 155 days consistent with our ethos that every minute 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 a top-line result presentation recently in Orlando at the MDA meeting. It was a trip I won't soon forget. I was struck by the excitement of our data that our data generated not only within the LGMD2I community but more broadly given the striking results associated with BBP418 suggest 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 to date, 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, a top-line presentation of our Calibrate Phase 3 data at the European Congress of Endocrinology in just a matter of days. Here again, we'll be looking to drive excitement into the broader physician community and to educate the patient community and establish a base of data that together with our publication of our phase three data can ensure market building exercises can continue with high fidelity. Importantly, Bridge Bio 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 of genetic testing, ICD-10 codes, and broad disease awareness education helps butchers our belief that we will be able to find ever more patients in need of this compelling drug drug products furthermore our phase three and chronic hyperthyroidism will be commencing this summer and is bolstered by a recent published work that illuminates the central role that the calcium sensing receptor in the kidney plays in regulating calcium metabolism finally moving to achondroplasia the results from this trial came after lgmb2i 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 3 manuscript will be forthcoming in a major medical publication and we anticipate presenting the full propel 3 data set at a medical conference in the second half of 2026. early commercial research here suggests unaided awareness in excess of 40 percent amidst the prescribing physician community which those of you who are commercialized friends know is a very high starting point and certainly higher than 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 bridge bio's founding principles the company was built on two 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 why we talk about mpv why we anchor to intrinsic value, why we try to make the right economic decision at every fork. The reason for that is because if we 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 from the investors we serve given the large disconnect between our NPP per share and our firm's intrinsic value. Even with the revision of Vindamax's entry from 2035 to mid-2031 or early 2032, our intrinsic value remains markedly higher than what 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 a portfolio whose risk profile has fundamentally improved. Of note, we've employed this technique in the past some six times some six times in aggregate even accounting for the pre-part a 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 credible 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 efforts.

Thank you, Neil, and good afternoon, everyone. Q1 was another strong quarter for a Truby, delivering an impressive 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. Bill rates, cap rates, gross to net, compliance, and persistency all continue 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, but TRUBI did not experience reauthorization disruptions for two reasons. Part D, as in David, is a continuous plan-based model which avoids the annual renewal friction of Part B, as in void. That structural advantage matters. In addition, in 2025, the average copay for a Truby patient was only $190 for the entire year, making many patients pay only $0 out of pocket as well. Our field team is executed with exceptional discipline to keep patients on therapy without interruption. We hire exceptional people, and those people make sure that any patient who wants a near complete stabilizer can get a Truby, and importantly, can stay on a Truby. Turning to our pipeline, we are encouraged by early indicators across our three anticipated near-term launches, an LGMD2IR9, ADH1, and a chondroplasia. An 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, find every patient who can benefit and be ready to serve them from day one 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. And Calerit would be the first medication to target the disease mechanism correctly, and it's orally administrated. Physician excitement is high, and we're ready to move immediately at approval. In achondroplasia, we are preparing for a global launch with a truly differentiated clinical profile. Infragratinib is the first medication to demonstrate statistically significant improvement in body proportionality, not just improvements in average height velocity, and the only oral option in the category. For families seeking an alternative to injectables or returning to treatment after a negative experience, the clinical profile and route of administration of infragratinib is very compelling. To summarize, Q1 continues to reflect a durable growth trajectory for Truby 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 of 2025. The $77.9 million increase was primarily driven by a $143.9 million increase in a Truvy net product revenue. A Truvy net product revenue in the quarter was $180.6 million, compared to $36.7 million in the same period of last year. Royalty revenue increased by $9.3 million to $9.5 million, primarily earned for MET product sales of Biantra in Europe and Japan. License and services revenue was $4.4 million compared to $79.7 million for the same period of last year. The decline reflects the recognition of one-time $75 million regulatory amount earned the prior year. Total operating expenses for the first quarter of 2026 for $290.5 million, compared to $218.4 million for the same period last year. The $72.1 million increase reflects deliberate and disciplined investment at Truby and preparations for three upcoming watches. 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 commercial 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 three launches. Turning to the operating line, in the first quarter, we recorded a $106 million operating For the last five quarters, our loss from operations is narrowed by more than 50% due to OPEX discipline, there was a strong execution on intrusion. Looking at the quarterly trend, if we back out one-time milestone payments, we've seen an improvement in the operating line every quarter since the truly launch. Looking ahead, we expect the trend in loss from operations to flatten over the next two quarters as we ramp up launch readiness activities for the next three products and continue narrowing toward the end of this year to 20.67 as we transition to a P&L break-even, followed by cash flow positivity, which we expect to be sustainable from that point on. Starting with the balance sheet, we ended the first quarter with $940.2 million. in cash, cash report loans, and marketable securities, compared to $587.5 million at the end of last year. We believe our current cash position provides us with significant runaway to fund our operating activities, advance our three late stage programs towards approval and launch, and continue to invest in truly commercial growth, all while maintaining financial discipline we've demonstrated today. With that, I'll do a call back to Orichima.

Thank you, Neil, Mike, and Tom.

Operators, please open the line for questions now. thank you ladies and gentlemen we will now begin the question and answer session and at this time I would like to remind everyone in order to ask a question please press star followed by the number one on your telephone keypad and if you would like to enjoy your question press star one again in the interest of time we kindly ask everyone to limit themselves to one question only we'll pause for a moment to compile the q a roster thank you our first question comes from the line of Tyler Van Byrne with TD Calvin. Please go ahead.

Hello, this is Sam on for Tyler. Thanks very much for taking our questions and congrats on another strong quarter. I was just wondering, can you guys talk about what's driving the continued Truby acceleration and specifically what you're seeing in those treatment-naive patients? Thank you very much.

Hey, this is Matt. I'll take that one and thanks for the question. We're definitely excited about the continued performance of a Truby. 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 of therapy and ATTR-CM, and near-complete stabilization, along with the Truby's speed and showing separation from placebo, is attractive to patients and HTPs.

They want something that's going to work quickly, and a Truby has shown that can do that and recently as you heard from neil in his uh original remarks the real world evidence has backed all of these points up for both the treatment naive patients and the switch patients and that's helping to drive our share upwards yeah maybe the only thing i'd add there is um the serum tqr story i think you know you saw a bevy of papers both from us but that importantly from others uh suggesting the numbers that i that i put forth the midper deciliter increase associating with with pretty remarkable decreases in mortality downstream and you know obviously as a reminder we when we put patients on um agramidus following administration of tefaminis coming out of our phase three trial you saw 3.4 big per deciliter increase and everyone increased their serum ttr level so it doesn't really matter how you measure it um you're just getting increases in serum ttr the question outstanding was never i don't know matt if you'd agree with at whether or not is a better stabilizer. 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 the CRM-TDR work was just the first part of that. I think you can see a lot more of that in the coming 12 to 24 months. Really, it's just because we have enough patients now with enough duration that we can start to ask and answer those questions.

Our next question comes from the Lanif Manny Furuhar with Lyric Parkers. Please go ahead.

Hey, guys. Thanks for the question. Congrats on results. In the aftermath of the Tafaminist IP evolution and some clarity on genericization of TAS, not of Acoraminis, walk us through operationally how you think about the development and commercial strategy for Acoraminis into 2031, 32, and beyond.

Yeah. Hey, Manny. Thanks for the question. So, the clarity on randomized IT is clearly a meaningful positive for Bridge and a TRUBI. You know, we now have at least six years of runway before genetics, which is more than enough time to reach peak share. And obviously, this all materially reduces any tail risk we would have to the NPV of the program. I don't think the resolution really changes our commercial strategy. We've always been focused on establishing a TRUBI as the treatment of choice in ATTRCM, given its differentiated profile, and we're executing against that. I think you heard both Neil and Matt talk about the vevy of literature that we're producing as well as all the commercial activities that we're undertaking to really reinforce that differentiation and drive share. I guess what I'll say at the end is just, you know, we've shared our beliefs that a Truby will be a $4 billion drug last year in our Q125 earnings call. I don't think we'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, but Truby is likely to keep growing even after 2032, given the ecosystem and channel dynamics that exists here with Part B. And so that's kind of what's driving our confidence. So, yeah, I think it's a good thing for us to reduce the error bars on our valuation.

Yeah, maybe I'd add to that. I mean, you know, I personally did think, Mania, 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 not material as i mentioned in my comments and the bigger thing is like you know all of these differentiating studies that we're running it is really starting to resonate um with clinicians in addition to the fact that the access programs are are superior so you know i guess what your question is really leading to is like will we run a double line head-to-head we still might we reserve the we reserve the option to do that certainly we've been excited to do that in the context of either TPR levels or anti-pro BMP, 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 Apontosyn trial to really understand what those event rates look like in the context of clinical trials to see if there are some double-blind head-to-head opportunities, you know, but there's nothing obvious right now, so let's continue doing the role of evidence studies which I think are the best honestly characterization of sort of differential competitive dynamic our next question comes from the line of fear and eminemid piper sandler please go ahead yeah hi guys thanks for taking my questions can you walk us through the board's decision to authorize the 500 million dollar 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 thanks yeah i can take that off i mean i think right now the focus is uh on focus execution against the pipeline that we have right now but 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 lgm dpi launch that i referred to the adh1 launch the acon launch even is totality i think you know we're projecting uh market share numbers well in excess of what typically a third mover gets um in that space and then you think about the consequential additional indications both in terms of hypocon and importantly in terms of chronic hypothyroidism that we're kicking off and then we've got the canavan program so like that constellation of activities is more than more than enough to drive long-term growth for any company and that's kind of what we're focused on do we can we fully finance all of that comfortably um and we feel like we can and therefore beyond that what ought we do with excess capital um and we think the best uh relative um you know in terms of relative return uh way that we can deploy capital right now is into our own chairs just given the disconnect between intrinsic value and uh and where we're trading so that's really what the discussion came down to it's hard to you know i know that i know the normal way that a biotech would grow is say well who cares 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 it one that we we intend to employ uh here at bridgebots our next question comes from the line of core casimo with evercore isis hey good afternoon guys thanks for taking the question.

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 attributes differentiation versus TAS. Can you kind of unpack, you know, what this real-world data that you're seeing and how it compares with what was demonstrated in the clinical trial setting? Is anything different now than it was or just more of it? Thank you.

Yes, it's pretty different because recall that we had a significant left shift in our clinical trial. Like there was, you know, our placebo outperformed the on-drug arm of a tract. So there's kind of no way for us to actually, apples to apples, go across like diuretic intensive care. Oh, and by the way, like even the use of diuresis and rhythm control meds and, you know, SGLT2I use in this population, all of that stuff has changed pretty markedly. So it almost made it impossible accepting the in-trial comparisons we can make between defaminus and acrohamidus with all of the available caveats there, where, I mean, this is a reminder, acrohamidus outperformed defaminus in all aspects, which you did not see in Helios B. But I think real-world evidence is 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, you know, what we mentioned in terms of diuretic intensification. We certainly didn't look at, you know, downstream kidney effects like the, you know, the Nevada system did, but it's all resonant, I suppose, with the advantages that we think a TRUBI has versus in terms of mortality and hospitalization. It's just nice to see it actually play out in the real world.

Our next question comes from the line is Salim Syed with Mizuho. Please go ahead.

Hey, guys. Thanks for the question, and congrats on another great quarter. Just one from us, maybe, on Infragratinib and Propel3. 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 ACON community, both on the clinician side and family side. I'm just curious what the feedback has been there. how how the additional feedback informed your um expectations for the commercial opportunity i believe you said previously you sort of think about a con as being a two and a half billion dollar tam and maybe hypo con the same um just curious if you have any other color there to offer in the commercial opportunity thank you yeah thanks for the question i think the feedback from the clinician here here to me has been overwhelmingly positive you know acps are telling us that that they're constantly being asked by families when the oral is coming.

Both families are on treatment today, but more importantly, those that stay on the sidelines, which, as a reminder, makes up about 70 to 80 percent of the U.S. market. The consistent best-in-class profile is continuing to resonate with clinicians. They understand that AHP is best-in-class, the IT scores is best-in-class. We have the most attractive safety profile. And importantly, personality data points is the one that's resonating most with clinicians, because this is the only product.

Our next question comes from the line of Elimer with Barclays. Please go ahead.

Hey, guys. Thanks for taking the question. Two from me. First on limb girdle. So you submitted the limb girdle NDA very quickly from our math, about 150 days from top line, which is very fast compared to average. Can you walk us through where you stand on launch readiness and how you're preparing to get this drug into the hands of the limb girdle community from day one? And then a second question on the ATTR space, how are you thinking about what we will see from CardioTransform, specifically trial is DAP-SIG, and, you know, 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?

Hey, Allie. This is Tom. Good to hear from you. So I'm going to pass the one to Anna Wade here, and then the CardioTransform, Danielle, but first I want to say I'm really proud of our team for the quick turnaround on the NDA and you can expect that level of efficiency from the next two as well but over to Anna and Danielle.

Thanks for the question Ellie and thanks for the kind words Tom. So yeah we're really excited we have our commercial and sales leadership on board and we're getting ready to have the sale for us hired later this year. We also now have our medical leadership in place as well as a seasoned MSL team with neuromuscular and rare disease experience. In Q1 our major catalyst was the MDA conference as Neil mentioned in March where Dr. Kathy Matthews, a leading KOL in the field, presented our phase three interim analysis data and we had incredibly positive feedback at the meeting about the compelling data package. Since MDA we've heard about significant patient outreach to neuromuscular centres and internally we have received many inbound inquiries from both patients and physicians.

Our focus right now is driving awareness of the phase three data as well as emphasizing the importance of genetic diagnoses leveraging responses testing programs that are currently available so that day one of lunch we can be ready to get patients with therapy i think let me address her second question jeffy goes on cardio transform so yeah we we agree with you it's a super well-powered trial i mean obviously against the against the primary it looks good and even in the cell populations like if you take the same point estimate um from from helios b on combo and you and you just take the z score and then you say how many more pages would you need it's like you know two and a half times 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 interrogating um and so then it comes back to how do i cross route compare you know how do i understand this knockdown technology part of that will be how much knockdown they get and are they able to improve on the pk profile because you know i think that the reason that um that taft um you know performed similarly to ambutra or boot in the helios b trial has to do with the timing it takes for boot to get to mean max knockdown so you know take a lot longer than i would have expected so we'll see if that's the case with with their drug i think overall honestly cardio transform has more to do with the commercial dynamics without malum 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 stabilizers first line anyway uh number one number two i think when they're failing stabilizers they're going to want a better stabilizer on board in in combination so if that combo arm does it i don't see it having a meaningful super meaningful effect um for us again i mean you know i think from a biochemical standpoint you always want to preserve the native tetramer we're seeing more and more information about that you know i'm surprised people haven't been looking at the publicly available affairs database and what do things look like when you're knocking things down versus actually stabilizing and all consistent with the two 25 000 plus patient studies that we've seen out there suggesting that higher levels of serum tpr are better for you but um but i understand that in a short trial those those signals aren't necessarily resolvable but i think over the longer period of time stabilizers will continue to be frontline and then in combination i think we'll have a we'll have a pretty good um say there too but that's kind of that's how we're thinking about it we do think cardio transform 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 and risk reduction of 50 on hospitalization which i suspect if this study is consistent with the rest of the modern studies um are going to be a vast majority of the events will be hospitalization not not mortality um so i think that that bar our 50% reduction in hospitalization is kind of what I'll be looking for.

Our next question comes from Dilanus Anupam-Ramu with J.P. Morgan. Please go ahead.

Hey, guys. Thanks so much for taking the question, and congrats on the quarter. Quick encounter one here. I know the NDA is on track here for the first half of this year. And then the press release highlighted nearly 2,000 now 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? Thanks so much.

Daniel, good to hear from you. Yes, I would say that the foundation of everything that we're doing around patient identification is really awareness, awareness of the disease as an important distinct subset within hypopara. And then of course, awareness of hard drug and calories and the wonderful effect you can have for these patients. I think a major catalyst for awareness is gonna be the upcoming presentation at ECE next week, followed by US presentations later in the year and then hopefully a very high impact publication as well. But in the background, I think there's some important tactics and strategies that we continue to employ. First, as you mentioned, the ICD-10 code is a huge advantage to us here. Many rare diseases don't have an ICD-10 code. We're lucky to have one that's been in place for a couple years already, so there's a good amount of data in that. 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 into the offices, is spread awareness and also make sure that the patients they think they have are appropriately diagnosed with our sponsor genetic tests or other commercially available 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 is a dominant condition so there's 50 chance of passing on so when we tend to find one person with this condition if they look and go to a family event we find out that many of them uh brothers cousins aunts and uncles also

have the conditions so that's been a real uh valuable source to station 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 archulow with wolf fargo please go ahead uh hey there thanks for taking my questions and congrats on the progress uh just just a follow-up on infragratnib you know some recent commentary and some of the early kpis from the uv well launch seem positive and maybe you know early validation of kind of this market expansion pieces so just curious how you think about infragraphinib's profile versus the injectables and how this could further accelerate you know this market expansion and potential things yeah no thanks there you know i think

ultimately physicians and families are excited about the total package of infragraphinib right not just one thing it starts with a 2.1 centimeter change of baseline hb you know the largest effects shown across any of the three phase three which was remarkable ways consistent across the age groups And of course, as I mentioned earlier, the only statistic proven on proportionality is a demonstration of the importance of directly engaging SCFR3s. And then you have a differentiated safety profile, right, with no injection-flight reactions, no symptomatic extension, no hypotroposis. And I think the safety differentiation system is further playing out given the increasing and concerning signals of SCIFI and femur fractures, which are both looking like the top, you know, that go on.

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

Thank you, and good afternoon, and thanks for taking the question. Sticking with Infragratinib, I want to ask, with regard to the PROPEL infant and toddler study in patients who are newborns or up to two 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, you know, how you think about timing for that potentially being completed and being added to the label. Thank you.

Thanks for the question, Paul. Definitely, I think there's a lot of excitement from sites and from families after seeing the Phase 3 PROPEL 3 data, right, just kind of what we know from the field shows that the earlier intervening, the more likely your impact likely to impact clinical outcomes. I think we've seen definitely a burst of excitement there. So we'll provide an update on timing probably later on once this program progresses.

Our next question comes from the line of Andrew Taluate Jeffries. Please go ahead.

Hey, thanks for all the updates. Congrats on the execution. I have a bigger picture question for you guys on your broader pipeline. Now that you have succeeded across four major programs all the way through phase three, 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. Thank you.

Yeah, 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 that a biotech will launch three different products in three different indication settings alongside a pretty competitive market at the same time and that's going to take uh certainly against our lean backbone um all all of the uh all of the focus that that we have um you know i i also mentioned earlier that we have pretty significant um additional opportunities associated with every single one of our drug products um including some that we haven't talked about going to be a truby so i actually think that there's there's some pretty interesting stuff uh to do we have an internal pipeline um obviously prosecuting programs at adpkd lm and adality cardiomyopathy and um and uh the depleter antibody program in a ptr cardiomyopathy so that's additionally um you know programs that are very very capitally efficient but uh programs that we have an eye on uh today and then we've about backup programs against all of our current pipeline programs so that we can do what's right for the patient and physician community that continue to serve them as long as possible. So all of 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. French Bio has a significant stake in another company called Gondola Bio, which is really kind of one of our sister companies. And that has 17 programs that I think we've gone through ranging from phase two uh all the way back to the pre-clinical setting and it's a very very exciting slate of small molecules uh asos antibodies all targeting well-described genetic conditions at their source and so um i would say that but we're we're happy for that to be sort of an off balance sheet um r d uh exercise for now uh as is uh bridge bio-oncology therapeutics and really to focus on what we need to focus on here um which is continued prosecution of our pipeline programs, delivery of these important medicines to patients, and ultimately the capturing of the value that we have created for the investors that have backed us for many years.

Our next question comes from the line of Daniel Brill with Truist. Please go ahead.

Hey guys, thanks for the question and congrats on the 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. If 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 this step up here and moving forward. How should we think about the size of the quarterly patient pool that you're actively competing for? Thank you.

Yeah, sure. sure I mean I think I think this market continues to grow uh somewhere between like you know oh I think our internal numbers are somewhere between um 5,000 and 6,000 you know in that range uh a quarter in terms of these uh new patient uh new patient starts uh or new patients to to brand so I actually I don't think we have 4,500 for the last quarter I think it was it was it was above 5,000 but a little bit of this math has to do with like us guessing for our competitors what the inventory holdback was or what the inventory buys were and things of that nature so can never get it fully right we can get obviously our own patient numbers fully right um but that but that does suggest yeah 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 of three things one is making sure that the um the algorithms are are in easy mr so that people think a look for these patients. You know, there's all the tracer AI stuff that we've been doing, other algorithms that individual healthcare systems have been putting forth to just get people to think, ah, maybe this is a TDR patient. So that's one. Second is driving genetic testing into varying heavy populations. That's been helpful as well. And the third, probably the best, is just broad physician awareness and education through speaker bureaus really getting out into the um cafeteria practices and the community practices uh to educate them more so although that's positive i'd say on the negative side um we've heard quite a bit about this pyp shortage the technicians can um you know one of one of the um one of the ways that you can do the scans to get you know a definitive diagnosis alongside the eliza assay so that we have to keep an eye on um And, you know, we've heard about that before, like in 2025, we heard about that, I think, in the second or third quarter, you know, one of the big quarters, and the market continues to grow. But what, keep an eye on that. That's resolvable. There's three 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 TYP availability. But yeah, I guess, long story short, I believe that you should see, like, I think Evercore put out a nice analysis of this three years ago or so, it was like, you should see super linear growth in identification given the number of patients that we believe have ATTR cardiomyopathy coupled with the number of sponsors in the playing field and, you know, the availability of reasonable testing. I would expect that trend, that positive trend to continue with some, you know, with some mayor of ours quarter to quarter.

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

Good afternoon. Congrats on the great progress and thanks for taking our question. Maybe one more on InCaloret, if we may. As you look beyond the ADH1 opportunities, sort of the broader chronic hypoparathyroidism opportunity, how are you thinking about InCaloret's 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, you know, maybe looks a little bit like 25,000 patients in the U.S. and EU to, you know, versus 200,000. Thanks.

Yeah. Hey, 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 uh so in terms of intolerant and chronic hypopalachyroidism when we did our market research it's really three things which drove our excitement about the opportunity the first is that this would be the first oral option available in in this chronic setting and so the ability to give patients freedom from injection type reactions and all the pain that comes with it is something that resonates very well i would say the second thing is, if you look at the current options available, you do see an effect in terms of blood calcium normalization, but you don't really see that effect on urine calcium normalization. And I think within CalRIT, we have a very unique profile where we could normalize potentially both blood and urine calcium. And we saw that in our CalVe small phase 2 trial, where we had around 80% of the patients normalizing both blood and urine calcium. And these are patients who are very sick and and did not have the thyroid gland or any amount of the hormone. And then really the third thing is that there is a potential safety risk in terms of bone resorption from giving TTH at high levels for the whole day. And so I think we could completely avoid that. And I think actually the ADH1 readout significantly re-risk the toxopil for an caloric. And so I think that those three things, oral, urine calcium normalization, and potential benefit on safety is really what why we think we can compete and and get a reasonable share even in the chronic ibupata market obviously assuming that the trials work our next question comes from the line of shan liman with morgan stanley please go ahead hi this is morgan on for sean thanks for taking your question can you just remind us specifically for infagradinib and acontroplasia what kind of if any commercial preparations are taking place from bridge bio Thank you.

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, leadership has experience in both second to third market with security data, especially with experience and launching the world. We've also had a lot of experience from groups with skeletal displacement experience as well. So ultimately, I think right now we're trying to make sure that we get the word out, not just leading geneticists and AMCs, but also the broader community pediatric endocrinologists who are really excited about having an oral option, especially for families who have, you know, if they're not seeing these super specialized centers for care, I'm more interested in having something that's easier for families to administer. I just found that front.

Yeah, I think, too, remember we have a lot of the teams in place from the Atrube 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 the same individuals and we have relationships with all of 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 Linus John Boyle with William Blair. Please go ahead.

Hi team. Thanks so much for taking our question and congrats on a strong quarter. So patient advocacy groups for achondroplasia seem to have a pretty big voice in the indication. So, I'm wondering if you've had any interactions with them, and if you could speak to how the InfraGratinib profile is resonating there.

Yeah. Again, thanks for the question. I think that's just a core tenet of how we've been developing drugs since the very beginning. You know, we've been working alongside AXE groups, both in the United States and internationally, on making sure that their input and voice is implemented in our development program and how we think about influence. And for us, being able to target FGFR3 directly addresses their concerns of being able to look at not just height outcomes, but health outcomes as well, which is something we expect to play out in the longer term. And I think they've been 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 Bridge Bio 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, the Cuckoo is over conference call. You may now disconnect your lines. Have a pleasant day.