BridgeBio Pharma, Inc.

the whistle blowing I can hear the mighty roar I can hear the horses prancing in the pastures of the Lord Oh the train is coming and I'm standing here with you and it's bringing my baby right back to me

Well, there's something that's hard to explain.

And my baby's coming home now on the 5th of May. ¶¶ The bright horses are broken free from the fields. They are horses of love, their manes full of fire. They are part in the city, those bright burning horses. And everyone is hiding, no one makes a sound. And I'm by your side and I'm holding your hand Bright horses of wonder springing from your burning hand And everyone has a heart that is calling to something. And we're all so sick and tired of seeing things as they are. Horses are just horses and their manes aren't full of fire. The fields are just fields and there ain't no Lord. And everyone is hidden and everyone is cruel. There's no shortage of time and no shortage of fools. A little white shade dancing at the end of the road. It's just a wish that time can't dissolve at all. Thank you. Well, this world is plain to see. It don't mean we can't believe in something in any way. My baby's coming back now on the next train. I can hear the whistle blowing. i can hear the mighty roar i can hear the horses prancing in the pastures of the lord oh the train is coming and i'm standing here and it's bringing my baby right back to me

Good afternoon.

I will be your conference operator today. All lines have been placed and mute 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 one 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 bridge bias, future operating and financial performance, business plans and prospects, and strategy. These statements are based on current expectations and assumptions that are subject to risk and uncertainties, 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 uncertainties, Please refer to the disclosure in today's earnings release and Bridge Bio's periodic reports and SEC filings. All statements made here are based on information available to Bridge Bio 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, Bridge Bio, you may begin your conference.

Good afternoon, everyone, and thank you for joining Bridge Bio Pharma's first quarter 2026 earnings call. I am Chidnai Shukla, Senior Vice President, Strategic Finance. With me are Neil Kumar, our CEO, Matt Alton, our Chief Commercial Officer, and Tom Tremarki, 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 call for questions. For the Q&A session, We will be joined by Anand Sridhar, Anna Wade, and Justin Doe, who will lead our program with Encaladec, BBP418, and Instagram, respectively. With that, I'll turn it over to Neil.

Thanks, Jermaine, 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 orphaned 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 ABH1, 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, BridgeVile has demonstrated across now three approved products, with hopefully three more to come, the ability to take on post-Phase III 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 Atruvi. As many of you have read in the press release, we've had $180.6 million of Atruvi sales and U.S. AtruviNet 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 PTR monomer deposition, provides impact more quickly, and is consistent with the pharmacokinetics of TTR stabilization and ultimately achieves all of this in a cost-efficient and easy-to-access manner. Parenthetically, our data suggests a tripling in combo use with a 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 frontline, 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 to 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 the serum TTR story began to evolve in the marketplace, with multiple papers suggesting that 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 acramidus versus defamidus in the real-world setting. There were only really two real-world evidence studies reported to date, survival studies done in Columbia and by Dr. Masri that showed outperformance of acramidus both But those were comparing our trial data, and 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 SCAI, an independent real-world evidence study presented by the Valley Health System of Nevada reveals statistically significant outcome improvements associated with acaramidus as compared to defamitis. Building on this, we have a study in MedArchive that we will publish shortly in a major journal showing that Atruvi reduces diuretic intensification by 43% as compared to defamitis. We intend to continue studying and publishing on Atruvi's differentiation in the real-world setting and are glad to see the cardiology community doing so independently. Interestingly, one of the benefits of acramidus 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 an observed rapid hemodynamically mediated renal protective effect, which is unique to Atruvi as opposed to the other stabilizers and knockdowns in the space. We continue to present and publish on acramidus in 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 acramidus at month 54. including a remarkable statistically significant risk reduction of 45% in all-cause mortality with a p-value of less than 0.0001 and a 49% reduction in cardiovascular mortality, again, with a similar p-value versus placebo-to-aproamidus. All right, let's 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 MBA 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 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, BridgeBio has been supporting via grant family genetic testing events in the United States that continue to identify new patients with relatively high yields. although we're 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 buttress our belief that we will be able to find ever more patients in need of this compelling drug product. Furthermore, our phase three in chronic hyperthyroidism will be commencing this summer, and it's bolstered by 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 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 III dataset at a medical conference in the second half of 2026. Early commercial research here suggests unaided awareness in excess of 40% amidst the prescribing physician community, which for those of you who are commercialized friends knows 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 BridgeVile'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 while we talk about MPV, while we anchor to intrinsic value, while 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 for the investors we serve given the large disconnect between our MPV per share and our firm's intrinsic value. Even with the revision of Indamax'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 have employed this technique in the past, 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 liability 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 Atruvi, 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, growth 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. Atrubee 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 Boyd. 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 TRUBY. Turning to our pipeline, we are encouraged by early indicators across our three anticipated near-term launches in LGMD2IR9, 8H1, 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. Find every patient who can benefit and be ready to serve them from day one of approval. In ADH-1, 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. Calorit 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 Bridge Bio, 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, the less 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 attributing net product revenue. Attributing net product revenue in a quarter was $180.6 million compared to $36.7 million for the same period of last year. Realty revenue increased by $9.3 million to $9.5 million, primarily earned from net 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 last year. The decline reflects the recognition of $1.75 million regulatory milestone from the prior year. Total operating expenses for the first quarter of 2096. were $290.5 million compared to $218.4 million the same period of last year. The $72.1 million increase reflects deliberate and disciplined investment in Truby and preparations for three upcoming launches. SG&A expenses were $163.9 million, an increase of $57.5 million compared to the same period of 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 three launches. Thirdly, the operating line. In the first quarter, we recorded a $106 million operating loss. For the last five quarters, our loss from operations has narrowed by more than 50% due to OPEX discipline and a strong execution on intruders. Looking at the quarterly trend, if we back out one time on health zone payments, we've seen an improvement in the operating line every quarter since the true 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, 2027, as we transition toward 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 runway to fund our operating activities, advance our three related programs towards approval and launch, and continue to invest in truly supportive growth, all while maintaining financial discipline we've demonstrated today. With that, I'll turn the call back over to Chairman.

Thank you, Neil, Mike, and Tom. Operator, 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 withdraw 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 Buren 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 Atruvi 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 Atruvi. 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 in ACTR-CM, and near-complete stabilization, along with the TRUBY speed and showing separation from placebo, is attractive to patients and HCPs. They want something that's going to work quickly, and TRUBY 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 the switch patients, and that's helping to drive our share upwards.

Yeah, maybe the only thing I'd add there is the serum TTR story, I think, you know, you saw a bevy of papers, both from us, but then importantly from others, suggesting the numbers that I put forth, the mid-for-desolator increase associating with pretty remarkable decreases in mortality downstream. And, you know, obviously, as a reminder, when we put patients on agramidus following administration of tisamidus coming out of our phase three trial, you saw a 3.4 big 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. The question outstanding was never, I don't know, Matt, if you'd agree with this, whether or not agramidus 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 serum TTR work was just the first part of that. I think 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 enough duration that we can start to ask and answer those questions.

Our next question comes from the line of Manny Furuhara with Lyric Partners. Please go ahead.

Hey, guys. Thanks for the question. Congrats on the results. In the aftermath, of the Tassamidis IP evolution and some clarity on genericization of TAS, not of Acker Amidus. Walk us through operationally how you think about the development and commercial strategy for Acker Amidus in the 2031-32 and beyond.

Yeah. Hey, Manny. Thanks for the question. So the clarity on randomized IP is clearly a meaningful positive for Dredge and Atruby. 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 will have to the NPV program. I don't think the resolution really changes our commercial strategy. We've always been focused on establishing a Truby as the treatment of choice in ATTRCM, given its differentiated profile, and we're executing against that. I think you heard both Neil and Max talk about the value of literature that you're producing as well as all the commercial activities which we are undertaking to really reinforce that differentiation and try to 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, Truby is likely to keep growing even after going 32, given the ecosystem and channel dynamics that exist 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 introduce the error bars on our valuation.

Yeah, maybe I'll add to that. I mean, you know, I personally did think, My 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 with clinicians, in addition to the fact that access programs are. are superior, so you know I guess what your question is really leading to is like will we run a double blind head to head. We still might. We reserve the option to do that. Certainly, we've been excited to do that in the context of either TPR levels or antipro PMP. 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 upon trial to really understand what those evaporates 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 real-world evidence studies, which I think are the best, honestly, characterization of sort of differential competitive dynamics.

Our next question comes from the line of spirit. I'm in with 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 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.

I can take that off. I mean, I think right now the focus is on focus 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 today. I mean, the LGMD2I launch that I referred to, the ADH1 launch, the ACON launch, even its totality, I think, you know, we're projecting market share number as 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-con 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 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 ought 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 shares, just given the disconnect between intrinsic value and where we're trading. That's really what the discussion came down to. It's hard to, you know, 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 intend to employ here at Bridgewater.

Our next question comes from the line of Corey Casimo with Evercore ISI.

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 the Truby's differentiation versus Taft. Can you kind of unpack, you know, 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? 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 ATTRACT. So there's kind of no way for us to actually apple to apples go across like diuretic intensive care. Oh, and by the way, like even the use of diuresis and resident patrol meds and, you know, SGLT2I use in this population, all of that stuff has changed pretty markedly. So it almost made it impossible excepting the in-trial comparisons we can make between defamitis and acrohamidus with all of the available caveats there, where, I mean, just as a reminder, acrohamidus outperformed defamitis 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 what we mentioned in terms of diuretic intensification. We certainly didn't look at downstream kidney effects like the Nevada system did, but it's all resonant, I suppose, with the advantages that we think Atruvi has versus Amaris 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 of 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, you know, 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. Just curious what the feedback has been there How has the additional feedback informed your expectations for the commercial opportunity? I believe you said previously you sort of think about ACON as being a $2.5 billion TAM and maybe HypoCon the same. I'm just curious if you have any other color there to offer in the commercial opportunity. Thank you.

Yeah, thanks a bunch for the question. I think the feedback from the clinician and caregivers may have been overwhelmingly positive. You know, ACPs are telling us that they're constantly being asked by families, when the oral is coming. Both from families who are on treatment today, but more importantly, those that stayed on the sidelines, which, just as a reminder, makes up about 70% to 80% of the U.S. market. The consistent best-in-class profile is continuing to resonate with clinicians. They understand that the AHP is best-in-class, the IT score is best-in-class, we have the most attractive safety profile, and, importantly, proportionality. The proportionality data point is the one that's resonating most with clinicians, because this is the only product that has a stat sig result in proportionality in a three to eight age group population. And this was just a demonstration of how directly targeting FGFR3 impacts more than just height here is about health. And on that note, we will be releasing more data on how Infragram is benefiting more than just height in some medical conferences later this year, some of which has never been seen before in a 52-week placebo-controlled trial, so stay tuned there. Now, ultimately, all this is to show that it really reinforces our belief that we will have a peak market share, potentially more than 65% market share, as valued by our market research here.

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

Hey, guys. Thanks for taking my question. Two from me. First on limb girdle. So you submitted the limb girdle NDA very quickly from our mouth 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. How are you thinking about what we will see from CardioTransform, specifically 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, Ellie. This is Tom. Good to hear from you. So, I'm going to pass, so I'm going to want to add a weight here, and then the CardioTransform to Neil, 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 then 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. We're getting ready to have the sales rep hired later this year. We also now have our medical leadership in place, as well as the 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. Katherine Matthews, a leading KOL in the field, presented our Phase III interim analysis data, and we got incredibly positive feedback at the meeting about the compelling data package. Since MDA, we've heard about significant patient outreach to neuromuscular centers, and internally, we have received many inbound inquiries from both patients and physicians. Our focus right now is driving awareness of the Phase III data, as well as emphasizing the importance of genetic diagnoses, leveraging responsive testing programs that are currently available, so that day one of launch, we can be ready to get patients on therapy.

Our next question comes from Cardio. I think, let me address her second question, which I think was on CardioTransform. So, yeah, we agree with you. It's a super well-powered trial. I mean, obviously, against the primary, it was good. And even in the cell populations, like if you take the same point estimate from Helios B on combo, and you just take the Z-score, and then you say how many more patients would you need, it's like two and a half times more to hit a p-value of 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. And so then it comes back to how do I cross-trop compare? How do I understand this? Now that 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. That path you know perform similarly to and future or good in the helios be trial has to do with the timing, it takes for good to get to me 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 with their drug. I think overall, honestly, CardioTransform has more to do with the commercial dynamics with L-Myelom than it does with us, especially given the combo data that I just told you about. I think people are going to reach for stabilizers 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 combo alarm does it, I don't see it having a meaningful, super meaningful effect for us. Again, I mean, you know, 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 cmtpr 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 a longer period of time, stabilizers will continue to be frontline, and then in combination, I think we'll have a pretty good stay there too. But that's how we're thinking about it. We do think cardiotransform 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 that bar 50% reduction in hospitalization is kind of what I'll be looking for.

Our next question comes from the line with JP Morgan. Please go ahead.

Hey, guys. Thanks so much for taking the question, and congrats on the quarter. Quick and tolerant one here. 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. Yeah, so 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 our drug and calorie and the wonderful effect it can have for these patients. I think a major catalyst for awareness is going to be the upcoming presentation at ECE next week, followed by U.S. 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 leadership in a more surgical way to go into the offices spread awareness, and also make sure 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 than I would have thought, is just family tracing. Makes sense when you consider this is a dominant condition, so there's a 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 brothers, cousins, aunts and uncles also have the condition. 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 Archulow with Wells Fargo. Please go ahead.

Hey there. Thanks for taking my questions, and congrats on the progress. Just a follow-up on infragratinib. You know, some recent commentary and some of the early KPIs from the UB Well launch seem positive, you know, early validation of kind of this market expansion pieces. So, just curious how you think about infographic profile versus the injectables and how this could further accelerate, you know, this market expansion potential. Thanks.

Yeah, no, thanks, Eric. You know, I think, ultimately, physicians and families are excited about the total package of infographic, right, not just one thing. It starts with a 2.1 centimeter change in baseline HP, you know, the largest effects shown across any of the three phase briefs, which was remarkable across the age group. And of course, as I mentioned earlier, the only statistic proven on proportionality, a demonstration of the importance of directly engaging FGFR3. And then you have our differentiated safety profile, right, with no ejection side reaction, no symptomatic extension, no hypertrichosis. And I think the safety differentiation is further playing out given the increasing and concerning signals of SCIFI and femur fractures, which are both looking like potential CMV collapse effects. You know, the bow on top of this for us being the daily oral based on historical benchmarks we know that when oil enters a market with only injectables it expands the market on average by three to four times at year five after launch so ultimately the families here will have a choice of either 365 injections a year 52 injections a year or zero and i know which one those families prefer our next question comes from the line of ball toy with goldman fax please go ahead

Hi, thank you, and good afternoon, and thanks for taking the question. Speaking with the infogratnib, 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 how you think about timing for that potentially being completed and being added to the label? Thank you.

Yeah, thanks for the question, Paul. Yeah, definitely, I think there's a lot of excitement from sites and from families after seeing the phase three, what's called three-gator, right? Just kind of what we know from the field shows that the earlier you intervene, the more likely your impact, likely to impact central affluence. I think we've seen definitely a burst of excitement there. So, you know, we'll provide updates on timing probably later on once we have some more clarity once this program progresses.

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

Hey, thanks for all the updates and 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, you know, a lot of our comments and actions have probably 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 certainly against our lean backbone all of the focus that we have. You know, I also mentioned earlier that we have pretty significant additional opportunities associated with every single one of our drug products, including some that we haven't talked about. We have to be a . So I actually think that there's some pretty interesting stuff to do. We have an internal pipeline. obviously prosecuting programs in ADPKD, LNN-Aidality cardiomyopathy, and the Depleter 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've got backup 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 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 phase. 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 all the way back to the preclinical setting. And it's 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 BRIC bio-oncology therapeutics, and really to focus on what we need to focus on here, which is continued prosecution of our pipeline program and 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.

Hi, guys. Thanks for the question, and 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. 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 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? Thank you.

Yeah, sure. I mean, I think this market continues to grow somewhere between like, you know, I think our internal numbers are somewhere between 5,000 and 6,000, you know, in that range, a quarter in terms of these new patient starts or new patients to brand. So actually, I don't think we have 4,500 for the last quarter. I think it was above 5,000. But a little bit of this math has to do with us guessing for our competitors what the inventory holdback was or what the inventory buys were and things of that nature. So we can never get it fully right. We can get, obviously, our own patient numbers fully right. But that does suggest, yeah, continued growth. I mean, will it continue to grow? I think so. Obviously, there's 250,000 patients with ACPR cardiomyopathy at the low end. In the US, and I think we're doing a better job of three things, one is making sure that the algorithms are are in easy a Mars, so that people think a look for these patients. You know the there's all the tracer AI stuff that we've been doing other algorithms that individual health care systems have been putting forth to just get people to think maybe this is a TTR patients that's one second is driving genetic testing into. very heavy populations that's been that's been helpful as well, and certainly probably best is just broad position awareness and education through speaker bureaus really getting out into the. capacity of practices and the Community practices to educate them more so all that's positive i'd say on the negative side we've heard quite a bit about this PYP shortage that technicians can. You know, one of the ways that you can do the scans to get a definitive diagnosis alongside the ELISA assay. So that, we have to keep an eye on. And, you know, we've heard about that before. Like in 2025, we heard about that, I think, in the second or third quarter. So, you know, one of the mid-quarters, and the market continues to grow. But keep an eye on that. That's resolvable. There's three major suppliers of that, and I think I expect in years going forward, we shouldn't see much more of this sort of supply chain iteration around PYP availability. 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's like you should see super linear growth in identification given the number of patients that we believe have ATK cardiomyopathy coupled with number of sponsors in the playing field and and you know the the availability of reasonable testing i would expect i would expect that trend to that positive trend to continue with some you know with some error bars quarter to quarter our next question comes from the lot of jason demansky with bank of america please go ahead

Good afternoon. Congrats on the great progress and thanks for taking our question. Maybe one more on Encalaret, if we may. As you look beyond the ADH1 opportunity to sort of the broader chronic hypoparathyroidism opportunity, how are you thinking about Encalaret'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. So, in terms of incalorated and chronic hypoglycemia, When we did our market research, it's really three things which drove our excitement about the opportunity. The first is that this will be the first oral option available in the chronic setting. And so the ability to give patients freedom from injection site 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 Calirix, we have a very unique profile where we could normalize potentially both blood and urine calcium. And we saw that in our LB small phase two trial, where we had, you know, around 80% of the patients normalizing both blood and urine calcium. And these were patients who were very sick and did not have the thyroid gland or any amount of the hormones. 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 ADH-1 readout significantly reduced the tox profile for Encaliris. And so I think that those three things, oral urine calcium normalization and potential benefit on safety is really why we think we can compete and get a reasonable share, even in the chronic hepatopathy market, obviously assuming that the trials work.

Our next question comes from the line of Shannon LeMann with Morgan Stanley. Please go ahead.

Hi. This is Morgan. I'm for Sean. Thanks for taking your question. Can you just remind us specifically for infagradinib and achondroplasia what

kind of if any commercial preparations are taking place from bridge bio thank you oh thanks for the question i think we've done a lot to build strong commercial and medical leadership here right bringing on uh for both sides of the business uh leadership has experience in both second to third market with security data especially with experience and launching world we've also had a lot of experience with from groups with skills of displacement experience as well. So ultimately, I think right now we're trying to make sure that we get the word out, not just to the leading geneticists and AMCs, but also to the broader kind of community pediatric endocrinologists who are really excited about having an oral option, especially for families who have, you know, if they're not seeing kind of these super specialized centers of care, more interested in having something that's easier for families to administer as well. So a lot of exploration going on at that front.

Yeah, I think to remember, we have a lot of the teams in place from the Atruvi 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 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 line. It's 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 infogratinib profile is resonating there.

Yeah, again, thanks for the question. I think that's been a core tenet of how we've been developing interruptions at the very beginning. You know, we've been working alongside advocacy 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 endpoints. And for us, being able to target FGFR3 directly, you know, 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 in our full-time legal extension program. 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, that concludes our conference call. You may now disconnect your lines. Have a pleasant day.