Hello, everyone. Thank you for joining us, and welcome to BridgeBio Third Quarter 2026 Earnings Call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. I will now hand the conference over to Chinmay Shukla, Chief Business Officer. Chinmay, please go ahead.

Good afternoon, everyone, and thank you for joining Bridge Bio Pharma's third quarter 2026 earnings call. I am Chinmay Shukla, Chief Business Officer. With me today are Neil Kumar, our CEO, Matt Outen, our Chief Commercial Officer, and Tom Trimarchi, our President and Chief Financial Officer. During today's call, we will cover another quarter of consistent growth for Atruby, along with new real-world evidence that continues to differentiate acramidus from tefamidus on outcomes that matter to patients, physicians, and payers. We will then turn to BBP418, where we are weeks away from potential launch. Finally, we will discuss the pipeline, where the PDUFA date for Infragratinib is now set for February 4th with priority review. and the PDUFA date for Encallerate is May 8th with priority review. We're also particularly excited to discuss updates from our chronic hypoparathyroidism program where we dose the first patient in our phase three trial. Following our prepared remarks, we will open the call for questions. For the Q&A session, we will be joined by the leaders of our Encallerate, BBP418 and Infragratinib programs. With that, I'll turn it over to Neil.

Thanks, Chinmay, and thanks everyone for joining today. As always, these calls are where we communicate relevant aspects of our business to investors, and so we welcome your questions and feedback. I'm excited to report updates from our TTR franchise and across the portfolio today as we enter into a new phase in our TTR launch, paired with three launches ahead of us in the next seven months. I will talk about that and further contextualize the numbers from this quarter in a moment. Before I do, I want to acknowledge that we are now annualizing to over $1 billion in the U.S. market and well over that globally with our Atruby Biontra franchise. This puts us ahead of the analogs we studied and used to guide our performance. This is coupled with an ever-evening playing field in the United States, a consequence of Atruby's growing size, its increasing evidentiary base, and the changing reimbursement environment, which we believe sets us up well in the quarters and years to come. It's interesting to remark that Atruby is the leading brand in Europe where rules around reimbursement and marketing are tighter. For today, we feel good about our continued revenue growth. We will have to wait for Pfizer's numbers later to accurately understand our share trajectory, but numbers from our other competitor this morning show that we are solidly in second place with respect to new patient starts and overwhelmingly so in the critical first-line setting. Obviously, we aspire for more and feel we have set a base to do so in the quarters and years to come. Before I comment further on our pipeline and revenue, I wanted to provide some brief context on how we think about the information we're sharing with you quarter to quarter. Obviously, the goal of these calls is to reduce information asymmetry between investors and managers so that the firm can be fairly valued over time. What this means is that we should be providing you information over time that informs your valuation model of the company. Although we meet in the context of these calls every quarter, it's a natural question to ask whether or not these updates provide salient information that allow you to revalue the firm. For instance, if a quarterly sampling is done on a system that only moves materially over the course of years, then all I'm providing you is noise. On the other hand, a quarterly sampling is inadequate for systems where salient differences are occurring on a weekly basis. Keeping that thought in mind, quarterly updates, as associated with our R&D activities, are generally too frequent. and we try to keep investors abreast of key R&D advances when they occur within our portfolio, generally through press releases, conference presentations and vitally publications. On today's call, I'll be summarizing a number of R&D items that we've already updated you on through these channels. However, in the commercial setting, quarterly updates contain real information content. In fact, our own modeling of some 1,040 launches suggests that the first quantum of time that contains predictive information for sales is the four-week rolling average. So from the perspective of frequency, quarterly updates on revenue contain real information, which I think we all know. But there's a second aspect of the information being provided, which is, what is the magnitude of change required to drive a change in your valuation of the firm, or critically, your peak year sales assumption? Put simply, how big do the changes need to be in order for the number to be a signal and not a reporting of noise? We asked this question as well of the 1,040 launches and more importantly drilled into the first couple years of launch to understand what the quarter-to-quarter variance in revenue growth looked like for brands that ended up doing over $3 billion in sales. Interestingly, there was on average a 20% variance quarter-to-quarter that did not meaningfully impact projected peak-year sales. If you go and look at brands like Eloquist, Tegresso, and others that we feel are of the size we believe the Atrubi Biantra franchise will be, A Truby's Performance This Quarter We observed continued commercial momentum this quarter. A Truby U.S. net product revenue was $253.2 million, an increase of approximately 14% quarter-on-quarter and approximately 134% year-over-year. Our growth now is predominantly coming from first-line new starts, which, as we've discussed, is our key focal area and predicts future total share in the marketplace. As I mentioned, we can't comment specifically on MBRX share on this call because we have not seen fires of quarterly numbers yet. But as we look over the marketplace as a whole, we continue to see strong performance amongst the approximately 2,900 physicians that have tried a TRUBY, mostly cardiologists at either academic medical centers or at high-volume heart failure practices. Where one big slice of the opportunity arises that is remaining is the over 60% of prescribers who have yet to try a TRUBY and who are primarily lower-volume, often non-cardiology specialists. Some of our competitors who are better resourced have begun reaching out to this longer tail of physicians, and you should expect us to pursue that opportunity as well as we build on our differentiated product profile and seek opportunities to educate a broader diaspora of prescribers. I'd like to take a few minutes on the tailwinds that define our differentiation so that you can share our excitement. I'll begin with the Truby's growing body of real-world evidence and then discuss the increasingly exciting kidney protective signal that we continue to elaborate on and then finally the readout from CardioTransform cementing stabilizers as the first line therapeutic backbone for ATTR cardiomyopathy. First, real-world evidence. I've said before that in the cardiovascular market where double-blind head-to-heads aren't immediately possible, real-world evidence set the bedrock of ultimate commercial performance. Since we last spoke, that bedrock has gotten considerably firmer with two large real-world comparisons of acramidus against tefamidus drawn from two different data types Pointing the same way and further reinforcing other real-world evidence studies that were published earlier this year. The first of these new studies was published in September in Cardiology and Therapy, the first peer-reviewed contemporary real-world comparative evidence study of TTR stabilizers. In Komodo U.S. claims data, acraminus significantly reduced the risk of early clinical worsening versus tefaminus with a 34% reduction in composite clinical worsening and a 43% reduction in in diuretic intensification. Separation in clinical outcomes emerged within weeks of treatment initiation and increased over time. The second came at HFSA just two weeks ago, where Dr. David Lanphier of Henry Ford presented an independent propensity score matched analysis of nearly 2,700 ATTR cardiomyopathy patients from Epic Cosmos, the largest electronic health record database in the United States. This is a contemporary cohort, patients from 2025, and it is the first EHR-based comparison of the two stabilizers. Acramidus was associated with an 18% lower risk of the composite of death, all-cause hospitalization, new-onset AFib, and diuretic intensification versus defamitis, with a hazard ratio of 0.82 and a p-value below 0.01. On the outcomes that matter most to patients and to payers, the effect was larger. A 27% lower risk of cardiovascular hospitalization, a 27% lower risk of heart failure hospitalization, and a 25% lower risk of all-cause hospitalization, all with p-values less than 0.001. The curve separated within the first month, and the result held across unadjusted, matched, and biomarker-adjusted analyses. Hospitalization isn't a soft endpoint. It is the disease. Second, the kidney. We've shared much of the detail before on what we've seen to date, so I'll be brief here. The kidney protective effect associated with acramidus does many things for us. It helps explain acramidus' early onset of action, the early EGFR dip, and the early separation and cumulative cardiovascular outcomes both occur about within a month. And our hypothesis that acramidus effectively rests the kidney to protect longer-term function Thank you for joining us today. And it generates a new hypothesis for future indications, namely whether acroaminus can benefit patients living with high proteinuric conditions. We are also beginning to see clues that kidney dysfunction may help indicate patients before ATTR cardiomyopathy is recognized clinically. Our statistical genetics team is engaged in further analysis and we look forward to sharing interesting findings from that research in the future. Finally, there were three key takeaways from ESC where the full cardio transform results were presented at the end of August. One, that adding a silencer on top of background stabilization does not improve outcomes. This effectively closes the door on combination therapy as the end state of this market. Two, knockdowns are interchangeable. Placebo-adjusted depth of serum TTR reduction was approximately the same between both observed knockdowns. and there was no differentiated impact of knockdown. Recall that both agents take many months to reach maximum knockdown, which is reflected in how long it takes for their event curves to separate from placebo in contrast to the early separation we observe with acramidus, which is as early as the first month. Three, there's plenty of room to improve on tofamidus. Within the placebo arm of Helios B, for instance, patients on background tofamidus showed a relative risk reduction of just 21.7% on all-cause death and recurrent cardiovascular events compared to those on no therapy at all. But simply, this is a stabilizer-first market, the bar set by tefamidus, and acramidus is the first and only near-complete stabilizer. ESC was also where we presented our own data and provided evidence of potential reversal of cardiac structural disease progression in ATTR cardiomyopathy. Serial CMR imaging from the Attributes CM study and its open-label extension showed clinically meaningful improvement in left ventricular systolic function in 54% of acroamnidus-treated participants versus 20% of placebo-treated participants at month 30, and in 53% of continuous acroamnidus participants at month 42 in a completer analysis. Participants treated with acroamnidus gained an unprecedented 65 additional days alive and out of the hospital by month 36, and month 54 data published simultaneously in the European Journal of Heart Failure showed a more than two-fold mortality difference favoring continuous acriamidus within the V122I subgroup. Building on that, we have dosed the first participant in Ascend ATTR, a phase 3B4 study of cardiac structure, function, and amyloid burden by cardiac MRI and echo over 36 months. And because we think the question of what comes after stabilization is still worth asking, We nominated BBP717, a next-generation monoclonal antibody depleter for ATTR cardiomyopathy, as a development candidate this quarter with an IND planned for 2027. Now to the three programs in regulatory review, beginning with BBP418 for LGMD2I, where the PDUFA date is November 27th, roughly four weeks from today. There is no advisory committee planned. This is in line to be the next approval in our portfolio, and if approved, The first therapy for any limb girdle muscular dystrophy. In the US, we have already identified more than 500 unique LGMD2I patients through claims, genetic testing, and account profiling. Globally, Europe has the highest prevalence of LGMD2I with more than 4,000 patients due to a founder mutation most often seen in people of North European ancestry. There, we have had multiple positive and high collaborative interactions with national health authorities and we intend to submit an MAA to the EMA in the first half of 2028. That submission will be based on the Fortify month 36 final analysis with top line results expected in late 27 or early 28. On the data, I'll remind everyone that Fortify met every primary and secondary endpoint at the 12 month interim with treated individuals improving while placebo declined across every key measure. At World Muscle Society earlier this month, we extended that story to the heart. which is among these patients' greatest concerns. Among participants with elevated high sensitivity troponin I at baseline, 100% on BBP418 returned to normal range by month 12 versus 40% on placebo. And 54% of treated participants had stable or improved ejection fraction versus 25% on placebo. Separately, the laboratory of Dr. John Vissing in Denmark, one of the foremost KOLs in the field, showed that BBP418 increased glycosylated alpha-dystroglycan above levels seen in asymptomatic FKRP carriers, i.e., people who carry a single copy of the mutation and don't get the disease. People sometimes forget that most therapies in progressive neuromuscular disease aim to slow decline. This one restores the underlying biology to unaffected levels, and patients get better. That is the type of transformative effect we seek to have with disease-modifying treatments. In order to have that effective course, we will need to deliver the drug to patients. So let me say a few words about our launch readiness. About 70% of LGMD2I patients receive care through the MDA Care Center Network. And since entering the field in August, our neuromuscular account managers have reached more than 70% of MDA centers and are expected to reach at least 90% by PDUFA. To find the patients who are still misclassified within the broader LGMD population, we launched Type Hype. A patient-facing campaign that encourages people with suspected LGMD to ask their doctor about genetic testing. The drug is manufactured and ready to go and channel. We are poised to deliver for a patient community that has waited far too long. Turning next to infogratinib for achondroplasia, we're heartened that the FDA accepted our NDA and granted priority review with a remarkable PDUFA date of February 4, 2027, meaning if all goes well, We have also submitted an MAA to the EMA and anticipate EU approval in the second half of 2027. Recall that Propel 3 is the only achondroplasia phase 3 study published in the New England Journal of Medicine. and remains the only program with placebo-controlled efficacy beyond annualized high velocity at 52 weeks, including statistically significant improvements on both proportionality and arm span. At ESPE in September, we presented additional benefits beyond height. Over 52 weeks, children on oral infi had a 38% lower rate of ear infections than placebo and their sleep apnea measures stayed stable compared to a 49% increase on placebo. We are also the only program in this space with an obstructive sleep apnea and otitis media data set. On the commercial side, our U.S. field team for oral infi is fully staffed with deep experience across growth disorders, including achondroplasia, rare genetic conditions, and competitive launches. Finally, in Caloret for ADH1, the NDA is under priority review with the BDUFA target action date of May 8, 2027, with no advisory committee planned. and our MAA has been submitted to the EMA with potential EU approval in the second half of 2027. NCALRA would be the first approved therapy specifically indicated for ADH1 in both the United States and Europe. The US field team dedicated to NCALRA has been trained and deployed and we have identified greater than 600 genetically confirmed patients up from approximately 500 last quarter. Since we last spoke, We have seen three further pieces of the story told by our phase three in study in ADH1, Calibrate. First, kidney. At ASN Kidney Week, we have shown that in addition to normalizing blood and urine calcium, incalorate was associated with a significant increase in kidney function at week 24 compared with conventional therapy with an EGFR change of plus 11 versus plus 3 mil per minute per 1.73 meters squared. Given that long-term complications of conventional therapy are nephrocalcinosis, kidney stones, and chronic kidney disease, that is not an incidental finding. Second, in the bone. At ASBMR, Incalorate demonstrated bone turnover by restoring the bone's own PTH production, which says that the drug is addressing the underlying biology of the disease rather than simply influencing symptoms. Third, how patients feel. 100% of participants on Incalorate reported improvement in at least one ADH symptom versus 46% on standard of care with the largest deltas in fatigue, muscle spasms, tingling, and brain fog, the things that people with this condition live with every day, even on preventional therapy. Our Calibrate Peds trial, our registrational phase 2-3 study in pediatric ADH1, has completed enrollment of the first of four cohorts, adolescents 12 to 17. and as I said last quarter, ADH1 approval is the beginning of incalorates potential, not the end. In October, we dosed the first participant in Reclaim HP, our global registrational phase three in chronic hyperparathyroidism condition affecting approximately 200,000 patients in the US and EU and a substantial expansion of the incalorate opportunity beyond ADH1. The study will enroll approximately 160 individuals with a primary endpoint, a proportion of participants achieving both blood and urine calcium normalization at week 24. I won't repeat the full mechanistic argument from last quarter, but I'd simply reiterate that endpoints are reliable, the drug's onset is rapid, and in our proof of concept, 80% of post-surgical patients normalized both blood and urine calcium within five days. We continue to see this as a relatively quick trial with a high probability of technical success, and we anticipate top-line results in the next 15 months. So put simply, we are a company with three launches in the next seven months. I'm not aware of many companies our size that have been handed that type of opportunity, and we don't intend to waste it. From the standpoint of operations, that means both focused execution against these three launches and taking advantage of our Silicon Valley roots to continue to pioneer a commercial model fit for today's technologies, where an AI is redefining how physicians are having conversations with themselves, patients with themselves, and physicians with their patients. Those conversations are being buttressed by new devices and technologies that allow us to measure ever more signals of health, from functional endpoints all the way back to genetics. We anticipate elaborating on how we intend to operate within this modern commercial concept on future calls, but needless to say, the parallel introduction of a genome that costs $250 coupled with AI's ability to identify and educate patients and physicians opens up new avenues that we are aggressively exploring. Finally, our strategic and financial posture continues to focus on taking advantage of our disconnect from intrinsic value through our previously discussed share buyback program and judicious use of resources to capture the full opportunity from each of our launches. With that, I'll turn it over to Matt.

Thanks, Neil. This is an exciting and pivotal moment for BridgeBio. Atruby is continuing its growth trajectory. The Padrufa date for infogradinib has been assigned as February 4th. We have a PDUFA date for NCALRET for ADH1 of May 8th, and of course, the imminent approval and launch of BBP418, which is just a few weeks away. This represents three unique NDAs, all assigned priority review by the FDA. I'll take you through updates for each of our programs, starting with Atruby. Atruby delivered another strong quarter. Net product revenue was $253 million, Patients on Atrubi are doing better than patients on tefamidus. At HFSA, we presented an independent analysis of 2,684 propensity score-matched patients with ATTR-CM from Epicosmos. Compared with tefamidus, acaramidus was associated with an 18% lower risk of death, hospitalization, new onset of atrial fibrillation or diuretic intensification, and 25 to 27 percent lower risk of all-cause cardiovascular and heart failure hospitalization. This builds on the Komodo analysis published in September. Different data sets, comparative contemporary populations, same answer. Thank you for watching. including invariant disease, V142I, also known as V122I. These results are what we have come to expect from the only near-complete stabilizer and is why we believe Atruvi is the stabilizer of choice. We are also investing in finding patients. In recognition of World Amyloidosis Day, we launched a nationwide ATTRCM education effort with community partners because too many patients remain undiagnosed. For the rest of my time, I want to focus on the three upcoming launches in order of PDUFA date. First, I'll start with BBP418. I'm really excited that we're mere weeks away from potentially launching the first and only treatment in LGMD2IR9. This represents a huge milestone for patients. In October, at the World Muscle Society Congress, we presented additional fortified data, including exploratory cardiac data, adding to an already strong profile. Cardiac involvement is a top concern for patients and HCPs, so this is a meaningful addition to the body of evidence on the impact of BBP418 in LGMD2IR9. Our field teams are hired and deployed with field medical engaging centers since May and our commercial team in the field since August. Thank you so much for joining us. Thank you for joining us. will be in place at launch. Thank you for watching. Second, I'd like to discuss infragratinib and achondroplasia, which is the biggest update since last quarter. On October 6th, the FDA accepted our NDA with priority review and set a PDUFA date of February 4th, 2027, ahead of the mid-2027 launch timing we described last quarter. Thank you for joining us. Our sales team is building on a foundation that has been in place for some time. Our field medical team has been meeting with centers of excellence and key opinion leaders for 14 months, and our advocacy team has been engaged with the chondroplasia community for over seven years. We continue to hear from HCPs and families that the anticipation of infragratinib continues to build. We're ready and excited for the February 4th PDUFA date. Thank you for joining us. Thank you for joining us. Our primary call points are endocrinologists and nephrologists, and this quarter we expanded sponsored genetic testing utilization and deepened disease education across both specialties. The effect is that patients are being identified who would be eligible for treatment upon approval. We have now identified more than 600 genetically confirmed patients, up from approximately 500 last quarter, and that number continues to grow. Looking beyond the U.S., we have also submitted MAAs to the EMA for both infragratinib and incalerate, positioning both for potential approvals in Europe in the second half of 2027. In summary, while we continue to grow with Truby, we also have three additional programs that are on track to launch at their respective PDUFA dates. With that, I'll turn the call over to Tom.

Thank you, Matt. Good afternoon, everyone. I'll now walk through our financial results for the third quarter of 2026. Our commentary will focus on GAAP financials unless otherwise noted. Total revenues for the third quarter of 2026 were $353.2 million compared to $120.7 million for the same period in 2025. The increase was primarily driven by growth in attributing net product revenue and $75 million in license revenue from a one-time sales milestone for BeyondTrust. reflecting strong uptake in Europe due to our differentiated product profile and excellent commercial execution by our partner Bayer. U.S. attribute net product revenue in the quarter was $253.2 million compared to $108.1 million in the same period last year. Royalty revenue was $20.5 million compared to $4.3 million in the same period last year, primarily earned from net product sales of Biantra in the EU and Japan. Total operating expenses for the third quarter of 2026 were $344.4 million, compared to $259.3 million for the same period last year. The $85.1 million increase reflects continued investment in Truby and preparations for our three upcoming launches. Turning to the operating line, in the third quarter, we recorded an $11.6 million loss from operations, compared to a $145.2 million loss in the same period last year. The improvement was driven by growth in a truly net product revenue, higher Biotra royalties, and a $75 million Bayer sales milestone, partially offset by a disciplined increase in OpEx. Aside from the one-time impact of this milestone, the operating line was particularly strong with 3Q due to timing of expenses related to our three upcoming launches. We anticipate OpEx will catch up in the fourth quarter of this year, followed by a more modest, steady growth paired with improvement of the operating line throughout 2027 and beyond.

Now, on to the balance sheet.

As of September 30th, 2026, our cash, cash equivalents and marketable securities were $1.5 billion, representing our strongest reported cash position in the company's history. Our strong cash position, together with our improving financial trajectory, allows us to fully resource our next phase of growth, including our upcoming launches and continued investment in Truby, while also investing in label expansion and lifecycle management. With that, I'll turn the call back over to Chimay.

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

We will now begin the question and answer session. Please limit yourself to one question. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Corey Kazimov with Evercore ISI. Your line is now open. Please go ahead.

Hey, guys. Good afternoon. Thanks for taking the question. Wanted to ask about Atrubiz. Obviously, there's been a lot of debate around how to think about quarter-over-quarter growth. So you put up a sequential increase of $31 million this quarter. Is that still... The right base to build off of as we think about Q4 into next year, or maybe asking it another way, what would need to happen, whether it's first line share, market growth, broader recognition of the compelling real world evidence you've been building or something else for that number to step up from here. Thank you.

Hey, Corey, thank you for the question. We do think that that 25 to 30 million is the right number near term. and eventually it will go up more from there. But let me pass it on to Matt, our chief commercial officer, to expand more upon that.

Yeah, thanks, Corey. So, I mean, we're really pleased with our Q3 results and the continuation of what's been a very strong launch for Atruby. As we've discussed previously, we're really focused on the first line setting. I think that's where everyone is sort of looking. And, you know, we believe this is where the most growth can be found. And this is where we've been growing the most with Atruby. Thank you so much for joining us. We've just started getting that out into the market. We believe that this type of data is going to continue to drive share for Truby in Q4 and also beyond.

Perfect. Thank you very much.

Your next question comes from the line of Tyler Van Buren with TD Cowen. Your line is now open. Please go ahead.

Hey, guys. This is Nick on for Tyler. Thanks very much for taking our question. So you mentioned Q4 and moving forward, but as you think about next year and the new 340B plan going into effect, how could this possibly or positively impact the true resales and potentially increase some new accounts coming online or increase prescribing patterns? Any thoughts on that would be very helpful, as well as anything that you guys are seeing in Q3 in terms of New Patient Starts, Breath of Prescribers, and Persistence of Treatment that could be leading indicators moving forward would be really helpful. Thanks.

Hey, Nick. Thank you for the question. I'm going to pass it again to Matt to discuss this.

Sure. Let me break it up into the two sections that you sort of described. So, you know, as I was just discussing, Atribi really growing well in the front line, but I can elaborate a little bit with some of the metrics that we look at when we think about how we're doing and what to consider in the future. Our gross-to-net remains and has been very stable for Atruby, and our persistency and compliance rates are extremely strong and high. So I think those two things in particular are something we watch closely, and they've been very consistent for us. You may have seen our recent marketing campaign of speed, strength, and stability, which highlights how quickly Atruby works and how well it keeps patients out of the hospital safe. Those two things have been since launch and continue to be two of the main reasons that physicians reach for a specific medication. We have the best team in the industry, so I have to throw out that, of course. And then one last thing to consider, too. The number of new prescribers who use a Truby in the first line continues to expand with consistent growth every single quarter. And as we've reported previously, When someone uses a Truby, they tend to keep doing it over time, which is going to lead to long-term increase in prescription and share for a Truby prescriptions. And then on your second point, you know, regarding ASP, I think much like the IRA change with Part D, the proposed ASP change really helps level the playing field. I need to stress, there's no way to know if the change will pass and what it will look like. But if it does, it's important to know that it impacts Part B as in boy medications, not Part D as in David medications like a true B. So there is no negative impact on a true B regardless of what passes. We could see a positive impact, but we really have to wait and see what that final legislation looks like. So I would say stay tuned. The expectation is that we're going to hear on that fairly soon.

Yeah, and just to build on what Matt said, I think I want to just highlight what Neil mentioned in his prepared remarks. Thank you for having me. In terms of leveling the playing field, Europe is a very good example of what a market with a level playing field looks like. We're extremely excited to see Bayer's very strong launch of Piantra in Europe. I think Piantra is now the leading brand in Europe, and you can see that even in our third quarter we had It's very helpful. Thank you very much for the call. Your next question comes from the line of Josh Shimmer with Cantor Fitzgerald. Your line is now open. Please go ahead.

Great. Thanks for taking the questions. A question on capital allocation, but maybe in two parts. As you expand the Truby Salesforce to address the long tail of prescribers, how do you think about the importance of acquiring another product to improve the efficiency of their calling efforts? And then, of course, there's a lot of chatter around the prospects of acquiring the outstanding ownership of Gondola to reintegrate that pipeline. So how do you think about both of those potential opportunities?

Yeah, Josh, thank you for the question. So maybe I'll try and unpack some of this. So yeah, I think we're very excited about Gondola's progress. They have a deep and exciting pipeline and they have some very talented leaders running the company and James Morgan and Peter. Having said that, I think as Neil mentioned in his prepared remarks for BridgeBio, We're focused on execution here because we have a broad opportunity in front of us with a true B, first of all, as you mentioned, you know, trying to go after the long tail. Our field force is right sized, but I think that it is going to require some investment. I think where we think we can innovate here is using AI and other tools to really think about what a modern commercial organization looks like. And obviously being here in the Valley is very helpful for that. Thank you so much for joining us. as well as the antibody program, which we just announced today. We have nominated a discovery candidate in which we think could be in the clinic, you know, not too distant of the future. So that's what we are focused on today. And maybe just taking a step back since you asked us our thoughts more broadly on capital allocation, you know, First use of capital is operations and fully funding the operations so that that comes first before anything else. For any excess capital, we think about three options. The first is just retaining the cash on our balance sheet and getting optionality value. Thank you for joining us. and we think about what our long-term shareholders will reward the most. So we really do think about shareholders before we make any of these capital allocation decisions and my hope is that this color helps you guys understand how the company will invest its capital. Thank you.

Your next question comes from the line of Biran Amin with Piper Sandler. Your line is now open. Please go ahead.

Hi, guys. Thanks for taking my questions. Maybe another on the balance sheet. You've got about $1.5 billion of cash and three product launches in the near term. How should we think about funding needs of a Truby and the new launches? And do you have what you need to get the profitability with the current balance sheet? Thank you.

Hey, Barron. This is Tom. Good to hear from you. So, yeah, very strong balance sheet, as you mentioned, with $1.5 billion of cash today. feel very comfortable with the cash that we need to continue executing on Atruvi and to launch the next three products in a way that's disciplined, but a resource to win, certainly in these critical markets and these communities that we're trying to serve here. So, you know, just piggybacking on Chimai's earlier comments, I feel like operational cash needs are well covered by that $1.5 billion of cash. And you can see that our cash flow from operations generally has been on a downward trajectory. Maybe to connect that a little bit with how we see the P&L evolving as well. So, We're three quarters away through 2026. I'm fairly confident that we'll average operating loss around $9,200 million a quarter this year. That's a big improvement from where we were at last year. That was about $130 million loss a quarter last year. And we were able to achieve this while ramping up sales and marketing spend for our coming through launches, really due to the fact that we're starting to see operating leverage show up from the attribute brand. So as we look forward to next year, I see a continued margin expansion for Matrubi, an improving operating line throughout the course of the year in terms of breakeven point. And this is really going to take us into 2028, where you get to the place where all four of the brands have a chance to be profitable on a standalone basis, and the P&L can really kind of take a unique shape, where you've got a very interesting and dynamic top line paired with a very strong and evolving bottom line as well.

Your next question comes from the line of Ellie Merle with Barclays. Your line is now open. Please go ahead.

Hey, guys. Thanks so much for taking the question. Just wanted to ask about the Ascendant Citizens Petition on infogratinib. Can you address how you're thinking about that, and do you see any impact on the review timeline or on the label? And second, I guess even if it's just from a perception perspective for physicians and families, How are you thinking about the commercial implications of this and how you're addressing the perception with education and awareness around the safety and neurocognitive profile? Thanks so much.

Hey, Ali. Thank you for the question. It's great to hear from you. I'm going to pass this one on to Justin Doe, who leads the Infogratnive franchise.

Yeah, thanks so much. So first, we do not anticipate that this will impact our review timeline or label. I think there were a lot of false assertions and assumptions in their citizens' position, and candidly, we think this tactic reflects how concerned they are about our impending launch. It's unfortunate they have to resort to a clear misuse of the citizens' petition mechanism, especially since they were just complaining about BioMirror doing the exact same thing to them about a year ago. We know the agency historically does not look favorably on petitions being used for competitive purposes. And we also know from the previous Bomber and Senda saga that advocacy groups here and clinicians in this space care a lot about having choice. And ultimately, we believe that their hypocrisy will come back to hurt them here. Now, the concerns that they raise have been disproven time and time again. First, the studies that they cite reflect full genetic knockout in mice, which everyone knows is very different than partial pharmacological impedition of the target. Non-clinically, we conducted all the required talk studies with detailed CNS assessments. And this is required really for any program before you start a phase two study, let alone a phase three. In addition, we now have data out beyond three years showing that there are no CNS effects or really any AEs indicative of peripheral or CNS FGFR1 or FGFR2 inhibition. And remember, the agency has cleared us to go even younger in the infant intolerant program. And really, at the end of the day, I think they and the physician community would be better served if they spent the same amount of time and energy on generating data for their program. And when we speak to clinicians, they don't really see this as a concern because they see the data that we have on hand. They understand really the fallacy of the argument that's being made here. And so I think this hasn't been a concern for us commercially.

Your next question comes from the line of Salim Syed with Mizuho. Your line is now open. Please go ahead.

Great. Thanks for the question, guys. Congrats on the quarter. Just one from us on 418, if possible. So obviously it's a holiday Hidufa here. Can you give us sort of like the logistics around that? What should we keep in mind as we head into the PDUFA, just given the holiday timing? And then also just remind us if you can, just given this was on an interim analysis, is base case here currently full approval or accelerated? Thanks so much.

Hey, Salim. Thank you for your question. I'm going to pass this one on to Anna Wade, who leads the neuromuscular franchise.

Hi, Salim. Thanks so much for your question. I'm pleased to say that we continue to have very positive interactions with the agency as they've been conducting their review. And given their continued engagement and feedback to date, we're confident that this will be a traditional full approval and everything is looking on track for the November 27th PDUFA action date. We're excited about the potential, obviously, for BB48 to serve this LGBTI community in the relatively near term.

Your next question comes from the line of Andrew Tsai with Jefferies. Your line is now open. Please go ahead.

Thank you. Congrats on the continued execution. On calories, now that the Reclaim study has started dosing patients, can you talk about how you guys are thinking about the market opportunity for the bigger hypo PTH market and how should we size that relative to ADH1? As for the phase three study itself, what do you guys think is the fundamental kind of efficacy bar for you to ultimately take meaningful share over your competitor? Thank you.

Hey, Andrew, thank you for the question. I'm going to pass it to Anant Sridhar, who leads ADH1 and Hypopata for us to answer it.

Yes, it's a great question, and it's exciting to advance Incalerate into to reclaim HP study of incalorate and chronic hypoparathyroidism, especially at a point where it is under registrational review, enables us to further interrogate its clinical profile and advance its potential clinical utility for a broader population. To directly respond to your question, we estimate around 200,000 prevalent chronic hypoparathyroid patients in the U.S. and Europe. Relative to ADH1, we estimate about 25,000 prevalent ADH1 patients in those same geographies. In terms of some of our early observations from the study, where we're seeing demand to be the most strongest, it's amongst three cohorts. And Chinmay actually had touched on these in our Q1 earnings call earlier this year. Those three populations are patients with persistent hypercalciuria. This is about 50%. of the chronic hypoperipopulation. Secondly, it's coming from patients with low bone mineral densities or osteopenic or osteoporotic individuals who may not be great candidates for PTH analogs given the potential iatrogenic risk of compression vertebral fractures that have been observed on those therapies. And then finally, the third population is patients with injection site reactions or needle aversions. This represents about 40% of the population based on our estimates. And these are the three cohorts that have expressed the strongest interest in our study. And then to your second question, what's the bar for success? We have a more stringent primary endpoint for this study as may have been seen in precedent studies and indication as we're evaluating the concomitant normalization of both blood and urine calcium relative to placebo. Robust clinical effect versus placebo paired with a consistent safety profile would meet our threshold for success and I think would substantiate a new option for patients in the community with chronic hyperparathyroidism.

Very good. Thank you.

Your next question comes from the line of Anupam Rama with JP Morgan. Your line is now open. Please go ahead.

Hey, guys. Thanks so much for taking the question. On 418 in Europe, you noted today that you're now planning on submitting an MMA in the first half of 28 based on your interactions with health authorities. Can you give us some color on what came out in those conversations and what's driving that timing? And how can we think about the EU opportunity in limb girdle versus

Thanks for the question. I'll pass it on to Anna to talk about it.

Thanks for the question. These are based on multiple productive meetings we've had with EU national authorities. In those meetings, the feedback we were getting was They reiterated the compelling nature of the data that we were showing with improvements from baseline in both ambulation and post-vital capacity. However, the main difference there is that these authorities indicated that they wanted to see the 36-month data as originally contemplated in the protocol. And that's basically because they don't have the same regulatory flexibility in Europe as we do in the U.S., So what we're planning on doing is completing the ongoing 36-month study in the second half of next year, and that data will be used to support the MAA filing, as you mentioned, in the first half of 28. In terms of the opportunity, we see this as a very meaningful opportunity, considering that this is a larger population in Europe than in the U.S., and we're estimating over 4,000 patients currently in Europe with LG and D2I.

Your next question comes from the line of Derek Archila with Wells Fargo. Your line is now open. Please go ahead.

Hey, good evening, and thanks for taking the questions. Maybe just staying on the limb girdle theme here, as we think about the limb girdle launch, how should we be thinking about modeling these first couple quarters? I know it's early, but how should we frame that ramp, and what sort of KPIs are you willing to share as soon as, you know, or soon after the launch starts? Thanks.

Yeah, hey Derek, thank you for the question. I'm going to pass it on to Anna to talk about this.

Thanks Chinmay and thanks Derek. So as you heard today, we're really excited about the LGMD2I launch and the potential benefits of B2B4 and 8 that can provide this community. We're feeling really good about the ongoing preparations for launch. Interactions in the field continue to be very positive and at recent medical meetings as well. The most requested data we've had from HCPs has been the cardiac data based on the fact that it is such a key driver of morbidity and mortality in this disease. And that data was recently shared at WMS as both Neil and Matt discussed. And so we're really feeling very good about the launch and physicians have actually been contacting our medical team, letting us know that they're ready and waiting for the potential new therapy for LG and D2I. As has also been mentioned, we've identified 500 unique genetically diagnosed patients to date, and we expect to fully penetrate that identified patient pool by year three. As we go through the launch, we'll be sharing what we're hearing from the field, and you can expect that more quantitative metrics will follow later, probably around the Q4 earnings call in early next year.

Yeah, I think just to build on that, Derek, We always communicate very transparently on launches. And as you know, we did the same thing with Atruvi. So we're going to think about what are the right metrics which investors should look at. And then as Neil mentioned in his prepared remarks, importantly, what is the right frequency at which we give those updates? So as we make those determinations, we will announce it. But you can expect us to talk about it and to talk about how things are going Thank you. Your next question comes from the line of Danielle Brill with Truist. Your line is now open. Please go ahead. Hi, guys. Thanks for taking my questions. On infogratinib, I wanted to ask about hypochondriplasia.

You mentioned the phase two, three, a cell study is expanding to higher doses to find the optimal dose. Can you walk us through the rationale for going higher? What the safety data is telling you there and how it affects the timeline to pivotal data? Thank you.

Yeah, Danielle, thanks for the question. I'll pass it on to Justin.

Yeah, thanks so much for the question. So as a reminder, the purpose of our phase two study was to do a dose escalation to find the optimal dose. Now, in achondroplasia, we stopped at 0.25 milligrams per kilogram, not because of safety reasons, but because we hit the optimal efficacy level for that indication, bringing AHP back to wild-type levels and showing STAT, SIG, and proportionality in arm span. In hypochondroplasia, which is a different indication, the optimal dose might be different, given the heterogeneity of mutations here and the different phenotype that's seen. And really, given the clean safety profile that we've now seen in Propel 3, long-term extension study, as well, of course, in our hypochondriplasia program, and the fact that we don't see any FGFR1 or 2 inhibition at these doses, we feel really comfortable exploring additional doses, and the agency is supportive of that decision as well. Ultimately, we're confident that we still have some distance from the top of the orthopedic index.

Your next question is... Your next question comes from the line of Jason Zemanski with Bank of America. Your line is now open. Please go ahead.

Good afternoon. Congrats on the great progress and thanks for taking our question. I guess moving to the payer side, we're hearing a large player has started restricting first-line use of a competing silencer. Does this apply to a truby? And I guess if so, which patients are affected and what does the path to access look like? I guess how should we be thinking about the impact on first-line starts and the risk of similar restrictions at other payers? Thanks.

Yeah, I'm going to pass it on to Matt to answer Jason, and it's great to hear from you.

Yeah. Hey, Jason. I think we're probably talking about United here. United hasn't made any changes to Atruby in 2026. It made a change back in mid-2025 to prefer Vindamax. But Atruby has been able to continue to grow since then, you know, since launch through all of this up till now. Our approval rates through appeal are over 90% and a TRUBY continues to grow quarter over quarter. So there's really nothing new here for a TRUBY. It always, especially in a Medicare market, comes down to HCP and patient preference. And if an HCP wants a TRUBY, they can get it for their patients. And we've shown this since launch.

Your next question. Your next question comes from the line of Joon Lee with UBS. Your line is now open. Please go ahead. Hi.

Thanks for taking our questions. We're really intrigued by the opportunity of in chronic hyperthyroidism. As you enroll these post-surgical patients, are you tracking who has partial versus hemi versus total thyroidectomies? Our understanding is that different post-surgical patients may present with varying degrees of severity and may have different responsiveness to intolerance. And related to that, what is your powering assumptions for the phase three reclaimed HP, and what is that based on? Thank you.

Hey June, thanks for the question and thanks for the deep work which you've done on our hypopara program. Let me pass it on to Anant to talk more about these questions.

Yes, and thanks for your interest in the program. We share it. On your first question on whether we're monitoring for or assessing the extent of parathyroid tissue loss as a result of Thank you for joining us today. In terms of powering assumptions, we have randomized the study three to one. We power the study to assess for a differential clinical benefit on achieving concomitant normal blood and urine calcium. And as a reminder, we informed these estimates based on what we saw in our proof of principle phase two with some more conservative estimates. In that study, we saw that none of the patients achieved that primary endpoint on conventional therapy, whereas 80% achieved that profile on incalorate within five days. So we've obviously taken some steps to be more conservative in our powering assumptions, but those signals from that study helped inform our powering estimates.

We have reached the end of the Q&A session. I will now turn the call back to Pablo Alvira for closing remarks.

Thank you everyone for joining us for our third quarter earnings call today. We appreciate your interest and we look forward to updating you again next quarter.

This concludes today's call. Thank you for attending. You may now disconnect.