Q3 2026 BridgeBio Pharma Inc Earnings Call

October 29, 2026

Operator: Hello, everyone. Thank you for joining us, and welcome to BridgeBio’s Q3 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 one to raise your hand. To withdraw your question, press star one again. I will now hand the conference over to Chinmay Shukla, Chief Business Officer. Chinmay, please go ahead.

Speaker #1: Hello everyone, thank you for joining us, and welcome to BridgeBio's Q3 2026 earnings call. After today's prepared remarks, we will host a question-and-answer session.

Speaker #1: If you would like to ask a question, please press *1 to raise your hand. To withdraw your question, press *1 again. I will now hand the conference over to Chinmay Shukla, Chief Business Officer.

Speaker #1: Chinmay, please go ahead.

Chinmay Shukla: Good afternoon, everyone, and thank you for joining BridgeBio Pharma's Q3 2026 earnings call. I am Chinmay Shukla, Chief Business Officer. With me today are Neil Kumar, our CEO, Matt Outten, 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 Attruby, along with new real-world evidence that continues to differentiate acoramidis from tafamidis on outcomes that matter to patients, physicians, and payers. We will then turn to BBP-418, where we are weeks away from potential launch. Finally, we will discuss the pipeline, where the PDUFA date for infigratinib is now set for 4 February with priority review, and the PDUFA date for encaleret is 8 May with priority review. We are also particularly excited to discuss updates from our chronic hypoparathyroidism program, where we dosed the first patient in our phase III trial.

Speaker #2: Good afternoon, everyone, and thank you for joining BridgeBio Pharma's Q3 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.

Speaker #2: During today's call, we will cover another quarter of consistent growth for Atrubi, along with new real-world evidence that continues to differentiate Acramidus from Tefamidus on outcomes that matter to patients, physicians, and payers.

Speaker #2: We will then turn to BBP-418, where we are weeks away from potential launch. Finally, we will discuss the pipeline, where the PDUFA date for Infogradnib is now set for February 4, with priority review, and the PDUFA date for Encalirit is May 8, with priority review.

Speaker #2: We're also particularly excited to discuss updates from our chronic hyperparathyroidism program, where we dosed the first patient in our phase-3 trial. Following our prepared remarks, we will open the call for questions.

Chinmay Shukla: 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 encaleret, BBP-418, and infigratinib programs. With that, I will turn it over to Neil.

Speaker #2: For the Q&A session, we will be joined by the leaders of our Encalirit, BBP 418, and Infogradnib programs. With that, I'll turn it over to Neil.

Neil Kumar: 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 am 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 US market and well over that globally with our Attruby/BEYONTTRA franchise. This puts us ahead of the analogs we studied and use to guide our performance.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: Market and well over that globally with our Atrubi Beyontra franchise. This puts us ahead of the analogs we studied and used to guide our performance.

Speaker #3: This is coupled with an ever-evening playing field in the United States, a consequence of Atrubi'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.

Neil Kumar: This is coupled with an ever-evening playing field in the United States, a consequence of Attruby's growing size, its increasing evidentiary base, and a changing reimbursement environment, which we believe sets us up well in the quarters and years to come. It is interesting to remark that Attruby 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.

Speaker #3: It's interesting to remark that Atrubi is the leading brand in Europe, where rules around reimbursement and marketing are tighter. For today, we feel good about our continued revenue growth.

Speaker #3: 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 sell in the critical first-line setting.

Speaker #3: 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.

Neil Kumar: Before I comment further on our pipeline and revenue, I wanted to provide some brief context on how we think about the information we are 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 is 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 am providing you is noise.

Speaker #3: 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.

Speaker #3: What this means is that we should be providing you with 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 allows you to revalue the firm.

Speaker #3: 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.

Speaker #3: 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.

Neil Kumar: 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 will be summarizing a number of R&D items that we have 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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 to 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 just a reporting of noise?

Neil Kumar: But there is 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 of 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.

Speaker #3: We asked this question as well—of the 1,040 launches, and more importantly, drilled into the first couple of 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.

Speaker #3: 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 Eliquis, Tigresso, and others that we feel are of the size we believe the Atrubi Beyontra franchise will be, you can see a very meaningful quarter-to-quarter change, but ultimately a trajectory that obviously supported multi-billion-dollar sales.

Neil Kumar: If you go and look at brands like ELIQUIS, TAGRISSO, and others that we feel are of the size we believe the Attruby BEYONTTRA franchise will be, you can see a very meaningful quarter-to-quarter change, but ultimately a trajectory that obviously supported multibillion-dollar sales. So adding this lens, in addition to our current quarter's data, we continue to believe that Attruby is tracking to meet or beat our $4 billion peak year sales assumption, and we believe that we have $4 billion in peak year sales across the other three brands that we will discuss in today's call as well. Let me now delve into Attruby's performance this quarter. We observed continued commercial momentum this quarter. Attruby U.S. net product revenue was $253.2 million, an increase of approximately 14% quarter on quarter and approximately 134% year over year.

Speaker #3: So adding this lens, in addition to our current quarter's data, we continue to believe that Atrubi is tracking to meet or beat our $4 billion peak-year sales assumption, and we believe that we have $4 billion in peak-year sales across the other three brands that we'll discuss in today's call as well.

Speaker #3: So let me now delve into Atrubi's performance this quarter. We observed continued commercial momentum this quarter. Atrubi U.S. net product revenue was $253.2 million, an increase of approximately 14% quarter on quarter, and approximately $134% year over year.

Neil Kumar: Our growth now is predominantly coming from first-line new starts, which as we have discussed, is our key focal area and predicts future total share in the marketplace. As I mentioned, we cannot comment specifically on NBRx share on this call because we have not seen Pfizer's 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 Attruby, 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 Attruby and who are primarily lower volume, often non-cardiology specialists.

Speaker #3: 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.

Speaker #3: As I mentioned, we can't comment specifically on MBRX share on this call because we have not seen Pfizer's 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 Atrubi, mostly cardiologists at either academic medical centers or at high-volume heart failure practices.

Speaker #3: One big slice of the opportunity that remains is the over 60% of prescribers who have yet to try Atrubi and who are primarily lower-volume, often non-cardiology specialists.

Neil Kumar: 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 would like to take a few minutes on the tailwinds that define our differentiation so that you can share our excitement. I will begin with Attruby'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 CARDIO-TTRansform cementing stabilizers as the first-line therapeutic backbone for ATTR cardiomyopathy. First, real-world evidence. I have said before that in the cardiovascular market where double-blind head-to-heads are not immediately possible, real-world evidence sets the bedrock of ultimate commercial performance.

Speaker #3: 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.

Speaker #3: 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 Atrubi'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.

Speaker #3: 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 sets the bedrock of ultimate commercial performance.

Neil Kumar: Since we last spoke, that bedrock has gotten considerably firmer with two large real-world comparisons of acoramidis against tafamidis 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 US claims data, acoramidis significantly reduced the risk of early clinical worsening versus tafamidis, with a 34% reduction in composite clinical worsening and a 43% reduction in diuretic intensification. Separation in clinical outcomes emerged within weeks of treatment initiation and increased over time.

Speaker #3: Since we last spoke, that bedrock has gotten considerably firmer, with two large real-world comparisons of Akeramidus against Tafamidus drawn from two different data types, pointing the same way and further reinforcing other real-world evidence studies that were published earlier this year.

Speaker #3: The first of these new studies was published in September in Cardiology and Therapy. It is the first peer-reviewed, contemporary, real-world comparative evidence study of TTR stabilizers.

Speaker #3: In Komodo U.S. Claims data, Akeramidus significantly reduced the risk of early clinical worsening versus Tafamidus, with a 34% reduction in composite clinical worsening and a 43% reduction in diuretic intensification.

Speaker #3: Separation and clinical outcomes emerged within weeks of treatment initiation and increased over time. The second came at HFSA, just two weeks ago, where Dr. David Lanfierre of Henry Ford presented an independent propensity score matched analysis of nearly 2,700 ATTR cardiomyopathy patients from Epic Cosmos to largest electronic health record database in the United States.

Neil Kumar: The second came at HFSA just 2 weeks ago, where Dr. David Lanfear 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 2 stabilizers. Acoramidis was associated with an 18% lower risk of the composite of death, all-cause hospitalization, new onset AFib, and diuretic intensification versus tafamidis, 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.

Speaker #3: This is a contemporary cohort—patients from 2025—and it is the first EHR-based comparison of the two stabilizers. Akeramidus was associated with an 18% lower risk of the composite of death, all-cause hospitalization, new-onset AFib, and diuretic intensification versus Tafamidus, with a hazard ratio of 0.82 and a p-value below 0.01.

Speaker #3: 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 health across unadjusted matched and biomarker-adjusted analyses.

Neil Kumar: 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 acoramidis does many things for us. It helps explain acoramidis' early onset of action, the early eGFR dip, and the early separation in cumulative cardiovascular outcomes both occur about within a month. Our hypothesis that acoramidis effectively rests the kidney to protect longer-term function, as evidenced by the sustained reduction in eGFR slope decline over 30 months. It strengthens the evidence of long-term benefit.

Speaker #3: 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.

Speaker #3: The kidney protective effect associated with Akeramidus does many things for us. It helps explain Akeramidus's early onset of action, the early eGFR dip, and the early separation and cumulative cardiovascular outcomes, both occur about within a month.

Speaker #3: And our hypothesis that Akeramidus effectively rests the kidney to protect longer-term function has evidenced by the sustained reduction in eGFR slope decline over 30 months.

Speaker #3: It strengthens the evidence of long-term benefit. The association of the eGFR dip with improved clinical outcomes shows this effect is good for the patients we serve, including those with renal complications, through a mechanism that appears to be similar to SGLT2 inhibitors.

Neil Kumar: The association of the eGFR dip with improved clinical outcomes shows this effect is good for the patients we serve, including those with renal complications, through a mechanism that appears to be similar to SGLT2 inhibitors. It generates a new hypothesis for future indications, namely whether acoramidis can benefit patients living with polyneuropathic 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 3 key takeaways from ESC where the full CARDIO-TTRansform 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.

Speaker #3: And it generates a new hypothesis for future indications, namely whether Akeramidus 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.

Speaker #3: 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 Cardiotransform results were presented at the end of August.

Speaker #3: 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.

Neil Kumar: 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 acoramidis, which is as early as the first month. Three, there's plenty of room to improve on tafamidis. Within the placebo arm of HELIOS-B, for instance, patients on background tafamidis 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. Put simply, this is a stabilizer-first market, the bar set by tafamidis, and acoramidis is the first and only near complete stabilizer.

Speaker #3: 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.

Speaker #3: 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 Akeramidus, which is as early as the first month.

Speaker #3: Three, there's plenty of room to improve on Tafamidus. Within the placebo arm of Helios B, for instance, patients on background Tafamidus 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.

Speaker #3: Put simply, this is a stabilizer-first market. The bar set by Tafamidus and Akeramidus 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.

Neil Kumar: 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 ATTRibute-CM study and its open label extension showed clinically meaningful improvement in left ventricular systolic function in 54% of acoramidis-treated participants, versus 20% of placebo-treated participants at month 30, and in 53% of continuous acoramidis participants at month 42 in a completer analysis. Participants treated with acoramidis 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 twofold mortality difference favoring continuous acoramidis within the V122I subgroup. Building on that, we have dosed the first participant in ASCEND-ATTR, a phase III/IV study of cardiac structure, function, and amyloid burden by cardiac MRI and echo over 36 months.

Speaker #3: 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 Akeramidus treated participants, versus 20% of placebo treated participants at month 30.

Speaker #3: And in 53% of continuous Akeramidus participants at month 42 in a completer analysis, participants treated with Akeramidus gained an unprecedented 65 additional days alive and out of the hospital by month 36.

Speaker #3: And month 54 data published simultaneously in the European Journal of Heart Failure showed a more than twofold mortality difference, favoring continuous Akeramidus within the V122i subgroup.

Speaker #3: Building on that, we have dosed the first participant in Ascend ATTR, a phase III V4 study of cardiac structure, function, and amyloid burden by Cardiac MRI and echo over 36 months.

Neil Kumar: Because we think the question of what comes after stabilization is still worth asking, we nominated BBP-717, 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 BBP-418 for LGMD2I, where the PDUFA date is 27 November, 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.

Speaker #3: And because we think the question of what comes after stabilization is still worth asking, we nominated BBP-717, a next-generation monoclonal antibody depleter for ATTR cardiomyopathy, as a development candidate this quarter with an IND planned for 2027.

Speaker #3: Now, to the three programs in regulatory review, beginning with BBP-418 for LGMD2i, where the PDUFA date is November 27, roughly four weeks from today.

Speaker #3: 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.

Speaker #3: In the U.S., 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.

Neil Kumar: 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 H1 2028. That submission will be based on the FORTIFY month 36 final analysis with top-line results expected in late 2027 or early 2028. On the data, I will 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 BBP-418 returned to normal range by month 12 versus 40% on placebo. 54% of treated participants had stable or improved ejection fraction versus 25% on placebo.

Speaker #3: We have had multiple positive and highly collaborative interactions with national health authorities, and we intend to submit an MAA to the EMA in the first half of 2028.

Speaker #3: That submission will be based on the 4 to 5-month 36 final analysis, with top-line results expected in late '27 or early '28. On the data, I'll remind everyone that 4 to 5 met every primary and secondary endpoint at the 12-month interim, with treated individuals improving while placebo declined across every key measure.

Speaker #3: 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 BBP 418 returned to normal range by month 12, versus 40% on placebo.

Speaker #3: 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 BBP-418 increased glycosylated alpha-dystroglycan above levels seen in asymptomatic FKRP carriers—that is, people who carry a single copy of the mutation and don't get the disease.

Neil Kumar: Separately, the laboratory of Dr. John Vissing in Denmark, one of the foremost KOLs in the field, showed that BBP-418 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 effect, of 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Neil Kumar: 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 in channel. We are poised to deliver for a patient community that has waited far too long. Turning next to infigratinib for achondroplasia, we are heartened that the FDA accepted our NDA and granted priority review with a remarkable PDUFA date of 4 February 2027, meaning if all goes well, we will launch the only oral product for achondroplasia in less than 12 months since the entry of the latest commercial injectable.

Speaker #3: 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.

Speaker #3: The drug is manufactured and ready to go in channel. We are poised to deliver for a patient community that has waited far too long. Turning next to Infragatinib for achondroplasia, we're heartened that the FDA accepted our NDA and granted priority review.

Speaker #3: With a remarkable PDUFA date of February 4, 2027, meaning if all goes well, we will launch the only oral product for a chondroplasia less than 12 months since the entry of the latest commercial injectable.

Neil Kumar: Infigratinib holds Breakthrough Therapy, Fast Track, and rare pediatric disease designations, and is the only therapeutic option in development for achondroplasia with BTD. We have also submitted an MAA to the EMA and anticipate EU approval in H2 2027. Recall that PROPEL 3 is the only achondroplasia phase III study published in the New England Journal of Medicine and remains the only program with placebo-controlled efficacy beyond annualized height 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 infigratinib 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.

Speaker #3: Infragatinib holds Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations, and is the only therapeutic option in development for achondroplasia with BTD. We have also submitted an MAA to the EMA, and anticipate EU approval in the second half of 2027.

Speaker #3: Recall that PROPEL3 is the only a chondroplasia phase III 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.

Speaker #3: At ESPE in September, we presented additional benefits beyond height. Over 52 weeks, children on oral IMFI had a 38% lower rate of ear infections than placebo, and their sleep apnea measures stayed stable compared to a 49% increase on placebo.

Speaker #3: We are also the only program in this space with an obstructive sleep apnea and otitis media dataset. On the commercial side, our U.S. field team for oral IMFI is fully staffed with deep experience across growth disorders, including a chondroplasia, rare genetic conditions, and competitive launches.

Neil Kumar: On the commercial side, our US field team for oral infigratinib is fully staffed with deep experience across growth disorders, including achondroplasia, rare genetic conditions, and competitive launches. Finally, encaleret for ADH1. The NDA is under priority review with the PDUFA target action date of 8 May 2027, with no advisory committee planned, and our MAA has been submitted to the EMA with potential EU approval in H2 2027. Encaleret would be the first approved therapy specifically indicated for ADH1 in both the United States and Europe. The US field team dedicated to encaleret 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 III study in ADH1, CALIBRATE. First, kidney.

Speaker #3: Finally, in Calorate for ADH1, the NDA is under priority review with a PDUFA target action date of May 8, 2027, and no advisory committee planned.

Speaker #3: And our MAA has been submitted to the EMA with potential EU approval in the second half of 2027. In calorate, it would be the first approved therapy specifically indicated for ADH1 in both the United States and Europe.

Speaker #3: The U.S. field team dedicated to in Calorate has been trained and deployed, and we have identified more than 600 genetically confirmed patients, up from approximately 500 last quarter.

Speaker #3: Since we last spoke, we have seen three further pieces of the story told by our Phase III study in ADH1, Calibrate. First, kidney.

Neil Kumar: At ASN Kidney Week, we have shown that in addition to normalizing blood and urine calcium, encaleret was associated with a significant increase in kidney function at week 24 compared with conventional therapy, with an eGFR change of +11 versus +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, encaleret 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.

Speaker #3: At ASN Kidney Week, we have shown that, in addition to normalizing blood and urine calcium, in calorate it was associated with a significant increase in kidney function at week 24 compared with conventional therapy.

Speaker #3: With an eGFR change of plus 11 versus plus 3 mL per minute per 1.73 meters squared. Given that the long-term complications of conventional therapy are nephrocalcinosis, kidney stones, and chronic kidney disease, that is not an incidental finding.

Speaker #3: Second, in the bone. At ASBMR, in Calorate, 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.

Speaker #3: Third, how patients feel. 100% of participants on in calorate 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 with this condition, the things that people with this condition live with every day, even on conventional therapy.

Neil Kumar: 100% of participants on encaleret 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 conventional therapy. Our CALIBRATE-PEDS trial, our registrational phase II/III study in pediatric ADH1, has completed enrollment of the first of four cohorts, adolescents 12 to 17. As I said last quarter, ADH1 approval is the beginning of encaleret's potential, not the end. in October, we dosed the first participant in RECLAIM-HP, our global registrational phase III in chronic hypoparathyroidism, a condition affecting approximately 200,000 patients in the US and EU, and a substantial expansion of the encaleret opportunity beyond ADH1.

Speaker #3: Our CALIBRATE-PEDS trial, our registrational Phase II/III study in pediatric ADH1, has completed enrollment of the first four of the first of four cohorts—adolescents ages 12 to 17.

Speaker #3: And as I said last quarter, ADH1 approval is the beginning of in calorate's potential, not the end. In October, we dosed the first participant in reclaim HP, our global registrational phase III in chronic hypoparathyroidism, condition affecting approximately 200,000 patients in the U.S.

Speaker #3: and EU, and a substantial expansion of the in-calorate opportunity beyond ADH1. The study will enroll approximately 160 individuals, with a primary endpoint of the proportion of participants achieving both blood and urine calcium normalization at week 24.

Neil Kumar: 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 5 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. We are a company with three launches in the next 7 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.

Speaker #3: 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 normalize both blood and urine calcium within five days.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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, wherein AI is redefining how physicians are having conversations with themselves, patients with themselves, and physicians with their patients.

Neil Kumar: 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, wherein 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. 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.

Speaker #3: 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.

Speaker #3: 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.

Neil Kumar: 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.

Speaker #3: 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.

Speaker #3: With that, I'll turn it over to Matt.

Matt Outten: Thanks, Neil. This is an exciting and pivotal moment for BridgeBio. Attruby is continuing its growth trajectory. The PDUFA date for infigratinib has been assigned as 4 February. We have a PDUFA date for encaleret for ADH1 of 8 May. Of course, the imminent approval and launch of BBP-418, which is just a few weeks away. This represents 3 unique NDAs, all assigned priority review by the FDA. I will take you through updates for each of our programs, starting with Attruby. Attruby delivered another strong quarter. Net product revenue was $253 million, up 134% from Q3 of last year, driven by continued share gains in the first line. The reason is the evidence, and it has become impossible to ignore. Across real-world data sets, the pattern is consistent. Patients on Attruby are doing better than patients on tafamidis.

Speaker #1: Thanks, Neil. This is an exciting and pivotal moment for BridgeBio. A true B is continuing its growth trajectory, the PDUFA date for infogradinib has been assigned as February 4th.

Speaker #1: We have a PDUFA date for in-calorate for ADH1 of May 8th. And, of course, the imminent approval and launch of BBP-418, which is just a few weeks away.

Speaker #1: 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 the true B.

Speaker #1: Acor B delivered another strong quarter. Net product revenue was $253 million, up 134% from Q3 of last year, driven by continued share gains in the first line.

Speaker #1: The reason is the evidence, and it has become impossible to ignore. Across real-world datasets, the pattern is consistent. Patients on a true B are doing better than patients on tefamatous.

Matt Outten: At HFSA, we presented an independent analysis of 2,684 propensity score-matched patients with ATTR-CM from Epic Cosmos. Compared with tafamidis, acoramidis was associated with an 18% lower risk of death, hospitalization, new onset of atrial fibrillation or diuretic intensification, and 25% to 27% 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. This is also exactly what you would expect. In our phase III trial, Attruby separated from placebo in just 3 months with a 50% reduction in cardiovascular hospitalization. At ESC, we show the survival benefit holds through 54 months, including in variant 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 Attruby is a stabilizer of choice. We are also investing in finding patients.

Speaker #1: At HFSA, we presented an independent analysis of 2,684 propensity score-matched patients with ATTR-CM from Epic Cosmos. Compared with tefamidus, acoramidus was associated with an 18% lower risk of death, hospitalization, new onset of atrial fibrillation, or diuretic intensification, and a 25% to 27% lower risk of all-cause cardiovascular and heart failure hospitalization.

Speaker #1: This builds on the Komodo analysis published in September. Different datasets, comparative contemporary populations, same answer. This is also exactly what you would expect. In our phase III trial, a true B separated from placebo in just three months, with a 50% reduction in cardiovascular hospitalization.

Speaker #1: At ESC, we showed the survival benefit holds through 54 months, including in variant 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 a true B is the stabilizer of choice.

Speaker #1: We are also investing in finding patients. In recognition of World Amyloidosis Day, we launched a nationwide ATTR-CM education effort with community partners, because too many patients remain undiagnosed.

Matt Outten: In recognition of World Amyloidosis Day, we launched a nationwide ATTR-CM education effort with community partners because too many patients remain undiagnosed. For the rest of my time, I want to focus on the 3 upcoming launches in order of PDUFA date. First, I will start with BBP-418. I am really excited that we are mere weeks away from potentially launching the first and only treatment in LGMD2I/R9. This represents a huge milestone for patients. In October, at the World Muscle Society Congress, we presented additional FORTIFY 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 BBP-418 in LGMD2I/R9. Our field teams are hired and deployed with field medical engaging centers since May and our commercial team in the field since August.

Speaker #1: 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 BBP-418.

Speaker #1: I'm really excited that we're mere weeks away from potentially launching the first and only treatment in LGMD2i R9. This represents a huge milestone for patients.

Speaker #1: 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 BBP-418 in LGMD2iR9.

Speaker #1: Our field teams are hired and deployed with field medical engaging centers since May, and our commercial team in the field since August. Ahead of approval, their work is focused on readiness on the ground, including disease state education and genetic testing awareness.

Matt Outten: Ahead of approval, their work is focused on readiness on the ground, including disease state education and genetic testing awareness. Through a combination of claims, genetic testing, and account profiling, we have identified more than 500 patients living with LGMD2I/R9 in the US, and about 70% of them receive care through the MDA Care Center Network. Our account managers have already introduced themselves to more than 70% of those centers and expect to reach more than 90% by launch. On awareness around LGMD Awareness Day in September, we launched Type Hype, a patient-facing awareness campaign encouraging people with suspected LGMD to talk with their doctor about genetic testing because many people living with LGMD2I/R9 remain undiagnosed. Patient support programs modeled on our prior launches will be in place at launch.

Speaker #1: Through a combination of claims, genetic testing, and account profiling, we have identified more than 500 patients living with LGMD2iR9 in the US. And about 70% of them receive care through the MDA Care Center network.

Speaker #1: Our account managers have already introduced themselves to more than 70% of those centers and expect to reach more than 90% by launch. On awareness, around LGMD awareness day in September, we launched TypeHype, a patient-facing awareness campaign encouraging people with suspected LGMD to talk with their doctor about genetic testing, because many people living with LGMD2iR9 remain undiagnosed.

Speaker #1: Patient support programs modeled on our prior launches will be in place at launch. Turning to Europe, based on multiple positive highly collaborative interactions with national health authorities in the EU, we intend to submit a marketing authorization application to the EMA in the first half of 2028, based on the fortified final analysis at the 36-month time point.

Matt Outten: Turning to Europe, based on multiple positive, highly collaborative interactions with national health authorities in the EU, we intend to submit a Marketing Authorisation Application to the EMA in H1 2028 based on the FORTIFY final analysis at the 36-month time point. Due to a founder mutation most often found in people of Northern European ancestry, Europe represents the highest density of LGMD2I/R9 prevalence globally, with up to 4,500 patients. All launch work streams are on schedule, and we are ready for the FDA’s decision in November and the opportunity to bring BBP-418 to the patients who need it. Second, I’d like to discuss infigratinib in achondroplasia, which is the biggest update since last quarter. On 6 October, the FDA accepted our NDA with priority review and set a PDUFA date of 4 February 2027, ahead of the mid-2027 launch timing we described last quarter.

Speaker #1: Due to a founder mutation, most often found in people of Northern European ancestry, Europe represents the highest density of LGMD2iR9 prevalence globally, with up to 4,500 patients.

Speaker #1: All launch workstreams are on schedule, and we are ready for the FDA's decision in November and the opportunity to bring BBP-418 to the patients who need it.

Speaker #1: Second, I'd like to discuss infogradinib and echondroplasia, 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.

Matt Outten: Our field team is hired, trained, and in the field profiling accounts and providing disease state education. The team is sized to compete effectively and to capture the market opportunity. They bring deep experience in rare disease, achondroplasia, and pediatric endocrinology. 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 achondroplasia community for over seven years. We continue to hear from HCPs and families that the anticipation of infigratinib continues to build. We are ready and excited for the 4 February PDUFA date and to bring the first and only oral option to families living with achondroplasia. Third, let me turn to encaleret in ADH1, which has a PDUFA date of 8 May 2027.

Speaker #1: Our field team is hired, trained, and in the field profiling accounts and providing disease state education. The team is sized to compete effectively and to capture the market opportunity.

Speaker #1: They bring deep experience in rare disease, achondroplasia, and pediatric endocrinology. Our sales team is building on a foundation that has been in place for some time.

Speaker #1: 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 achondroplasia community for over seven years.

Speaker #1: We continue to hear from HCPs and families that the anticipation for infigradinib continues to build. We're ready and excited for the February 4 PDUFA date and to bring the first and only oral option to families living with achondroplasia.

Speaker #1: Third, let me turn to encounter it in ADH1, which has a PDUFA date of May 8th, 2027. Of note, encounter it also received priority review, encounter it would be the first and only therapy specifically indicated for ADH1.

Matt Outten: Of note, encaleret also received priority review. Encaleret would be the first and only therapy specifically indicated for ADH1. The team we described last quarter is now on board and deployed in the field, with nearly 90% bringing rare disease experience to the team. We have also added field medical and field reimbursement roles this quarter. Most of our efforts have gone into finding patients. ADH1 is genetically distinct, but it presents like hypoparathyroidism, and most people living with it are carried under that diagnosis for years before anyone thinks to test for the mutation. So the work ahead of launch is disease state education, including diagnosis. Our primary call points are endocrinologists and nephrologists, and this quarter, we expanded sponsored genetic testing utilization and deepened the disease education across both specialties. The effect is that patients are being identified who would be eligible for treatment upon approval.

Speaker #1: The team we described last quarter is now on board and deployed in the field. With nearly 90% bringing rare disease experience to the team, we have also added field medical and field reimbursement roles this quarter.

Speaker #1: Most of our efforts have gone into finding patients. ADH1 is genetically distinct, but it presents like hypoparathyroidism, and most people living with it are carried under that diagnosis for years, before anyone thinks to test for the mutation.

Speaker #1: So, the work ahead of launch is disease state education, including diagnosis. Our primary call points are endocrinologists and nephrologists, and this quarter we expanded sponsor genetic testing utilization and deepened the disease education across both specialties.

Speaker #1: 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.

Matt Outten: 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 US, we have also submitted MAAs to the EMA for both infigratinib and encaleret, positioning both for potential approvals in Europe in H2 2027. In summary, while we continue to grow with Attruby, we also have three additional programs that are on track to launch at their respective PDUFA dates. With that, I will turn the call over to Tom.

Speaker #1: Up from approximately 500 last quarter and that number continues to grow. Looking beyond the US, we have also submitted MAAs to the EMA for both infogradinib and encounter it, positioning both for potential approvals in Europe in the second half of 2027.

Speaker #1: In summary, while we continue to grow Atruvi, we also have three additional programs that are on track to launch at their respective PDUFA dates.

Speaker #1: With that, I'll turn the call over to Tom.

Tom Trimarchi: Thank you, Matt. Good afternoon, everyone. I will now walk through our financial results for Q3 2026. Our commentary will focus on GAAP financials unless otherwise noted. Total revenues for Q3 2026 were $353.2 million, compared to $120.7 million for the same period in 2025. The increase was primarily driven by growth in Attruby net product revenue and $75 million in license revenue from a one-time sales milestone for BEYONTTRA, reflecting strong uptake in Europe due to our differentiated product profile and excellent commercial execution by our partner, Bayer. US Attruby 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 BEYONTTRA in the EU and Japan.

Speaker #2: 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.

Speaker #2: 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 Atruvi net product revenue and $75 million in license revenue from a one-time sales milestone for Beyontra.

Speaker #2: Reflecting strong uptake in Europe, due to our differentiated product profile and excellent commercial execution by our partner Bayer. US Atruvi net product revenue in the quarter was $253.2 million, compared to $108.1 million in the same period last year.

Speaker #2: Royalty revenue was $20.5 million, compared to $4.3 million in the same period last year, primarily earned from net product sales of Beyontra in the EU and Japan.

Tom Trimarchi: Total operating expenses for Q3 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 Attruby and preparations for our three upcoming launches. Turning to the operating line. In Q3, 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 Attruby net product revenue, higher BEYONTTRA 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 in Q3 due to timing of expenses related to our three upcoming launches.

Speaker #2: 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 Atruvi and preparations for a three upcoming launches.

Speaker #2: 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.

Speaker #2: The improvement was driven by growth in Atruvi net product revenue, higher Beyontra royalties, and a $75 million Bayer sales milestone, partially offset by a disciplined increase in OPEX.

Speaker #2: Aside from the one-time impact of this milestone, the operating line was particularly strong in 3Q due to timing of expenses related to our three upcoming launches.

Tom Trimarchi: We anticipate OpEx will catch up in Q4 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 30 September 2026, our 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 Attruby, while also investing in label expansion and lifecycle management. With that, I will turn the call back over to Chinmay.

Speaker #2: 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.

Speaker #2: Now onto 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.

Speaker #2: Our strong cash position, together with our improvement in financial trajectory, allows us to fully resource our next phase of growth, including our upcoming launches and continued investment in Atruvi, while also investing in label expansion and lifecycle management.

Speaker #2: With that, I'll turn the call back over to Jimmy.

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

Speaker #3: Thank you, Neil, Matt, and Tom. Operator, please open the line for questions now.

Operator: 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 *1 to raise your hand. To withdraw your question, *1 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 Cory Kasimov with Evercore ISI. Your line is now open. Please go ahead.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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 Casimov with Evercore ISI.

Speaker #4: Your line is now open. Please go ahead.

Cory Kasimov: Hey, guys. Good afternoon. Thanks for taking the question. Wanted to ask about Attruby. Obviously, there has 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 is first-line share, market growth, broader recognition of the compelling real-world evidence you have been building or something else for that number to step up from here? Thank you.

Speaker #5: Hey guys, good afternoon. Thanks for taking the question. I wanted to ask about Atruvi. Obviously, you've been a lot of debate around how to think about quarter over quarter growth.

Speaker #5: 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 and into next year?

Speaker #5: 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?

Speaker #5: Thank you.

Chinmay Shukla: Hey, Cory. Thank you for the question. We do think that that $25 million 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 Outten, our Chief Commercial Officer, to expand more upon that.

Speaker #3: 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.

Speaker #3: But let me pass it on to Matt, our Chief Commercial Officer, to expand more upon that.

Matt Outten: Yeah. Thanks, Cory. So we are really pleased with our Q3 results and the continuation of what has been a very strong launch for Attruby. As we have discussed previously, we are really focused on the first-line setting. I think that is where everyone is sort of looking, and we believe this is where the most growth can be found, and this is where we have been growing the most with Attruby. It is pretty clear that stabilizers are the therapy of choice in the first line, and as the only near complete stabilizer in ATTR-CM, we feel that Attruby is very well positioned for continued growth. There is still a lot of opportunity to diagnose and treat patients just due to the really high number of undiagnosed patients. And as you heard Neil Kumar discuss in his initial comments, that incredible real-world evidence and renal protective data for Attruby, we have just started getting that out into the market.

Speaker #6: 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 Atruvi.

Speaker #6: 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 we believe this is where the most growth can be found.

Speaker #6: And this is where we've been growing the most with Atruvi. It's pretty clear that stabilizers are the therapy of choice in the first line.

Speaker #6: And as the only near-complete stabilizer in ATTR-CM, we feel that Atruvi is very well positioned for continued growth. There's still a lot of opportunity to diagnose and treat patients.

Speaker #6: Just due to the really high number of undiagnosed patients. And as you heard Neil discuss in his initial comments, that incredible real-world evidence and renal protective data for Atruvi, we've just started getting that out into the market.

Matt Outten: We believe that this type of data is going to continue to drive share for Attruby in Q4 and also beyond.

Speaker #6: We believe that this type of data is going to continue to drive share for Atruvi in Q4 and beyond.

Cory Kasimov: Perfect. Thank you very much.

Speaker #5: Perfect. Thank you very much.

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

Speaker #4: Your next question comes from the line of Tyler Van Buren with PD Callan. Your line is now open. Please go ahead.

[Analyst] (TD Cowen): Hey, guys. This is Nick on for Tyler. Thanks very much for taking our question. 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 Attruby sales 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, breadth of prescribers, and persistence of treatment that could be leading indicators moving forward would be really helpful. Thanks.

Nick Lorusso: Hey, guys. This is Nick on for Tyler. Thanks very much for taking our question. 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 Attruby sales 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, breadth of prescribers, and persistence of treatment that could be leading indicators moving forward would be really helpful. Thanks.

Speaker #7: 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 Atruvi sales and potentially increase some new accounts coming online or increase prescribing patterns?

Speaker #7: 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, breadth of prescribers, and persistence of treatment that could be leading indicators moving forward would be really helpful.

Speaker #7: Thanks.

Chinmay Shukla: Hey, Nick. Thank you for the question. I am going to pass it again to Matt to discuss this.

Speaker #3: Hey Nick, thank you for the question. I'm going to pass it again to Matt to discuss this.

Matt Outten: Sure. Let me break it up into the 2 sections that you described. As I was just discussing, Attruby 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 are doing and what to consider in the future. Our gross to net remains and has been very stable for Attruby, and our persistency and compliance rates are extremely strong and high. I think those 2 things in particular are something we watch closely, and they have been very consistent for us. You may have seen our recent marketing campaign of speed, strength, and stability, which highlights how quickly Attruby works and how well it keeps patients out of the hospital.

Speaker #6: Sure. Let me break it up into the two sections that you sort of described. So as I was just discussing, Atruvi 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.

Speaker #6: Our gross to net remains and has been very stable for Atruvi. And our persistency and compliance rates are extremely strong and high. So I think those two things in particular, something we watch closely, and they've been very consistent for us.

Speaker #6: You may have seen our recent marketing campaign of speed, strength, and stability, which highlights how quickly Atruvi works and how well it keeps patients out of the hospital.

Matt Outten: Those 2 things have been since launch and continue to be 2 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. One last thing to consider, too. The number of new prescribers who use Attruby in the first line continues to expand with consistent growth every single quarter. As we have reported previously, when someone uses Attruby, they tend to keep doing it over time, which is going to lead to long-term increase in prescription and share for Attruby prescriptions. On your second point 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 is no way to know if the change will pass and what it will look like.

Speaker #6: 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.

Speaker #6: And then one last thing to consider too, the number of new prescribers who use Atruvi in the first line continues to expand. With consistent growth every single quarter.

Speaker #6: And as we've reported previously, when someone uses Atruvi, they tend to keep doing it over time, which is going to lead to long-term increase in prescription and share.

Speaker #6: For Atruvi prescriptions. And then on your second point, regarding ASP, I think much like the IRA change with Part D, the proposed ASP change really helps level the playing field.

Speaker #6: 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 note that it impacts Part B as in boy medications, not Part B as in David medications, like Atruvi.

Matt Outten: If it does, it is important to note that it impacts Part B as in boy medications, not Part D as in David medications like Attruby. So there is no negative impact on Attruby regardless of what passes. We could see a positive impact, but we really have to wait and see what that final legislation looks like. I would say stay tuned. The expectation is that we are going to hear on that fairly soon.

Speaker #6: So there is no negative impact on Atruvi regardless of what passes. We could see a positive impact, but we really have to wait and see what that final legislation looks like.

Speaker #6: So I would say stay tuned. The expectation is that we're going to hear on that fairly soon.

Chinmay Shukla: Yeah. Just to build on what Matt said, I wanted to highlight what Neil mentioned in his prepared remarks in terms of trying to go after the long tail of prescribers and really expanding the prescriber base. I do think that that is going to be one source of growth in the future for Attruby in the US. The other thing we wanted to highlight here, Nick, is 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 are extremely excited to see Bayer's very strong launch of BEYONTTRA in Europe. I think BEYONTTRA is now the leading brand in Europe, and you can see that even in our Q3, we had a little more than $20 million of royalty revenue.

Speaker #3: Yeah, and just to build on what Matt said, I think I wanted to just highlight what Neil mentioned in his prepared remarks. In terms of trying to go after the long tail of prescribers and really expanding the prescriber base, I do think that that is going to be one source of growth in the future for Atruvi in the US.

Speaker #3: And then just the other thing we wanted to highlight here, Nick, is in terms of leveling the playing field, Europe is a very good example of what a market with a level playing field looks like.

Speaker #3: We're extremely excited to see bears very strong launch of Beyontra in Europe. I think Beyontra is now the leading brand in Europe, and you can see that even in our third-quarter we had a little more than $20 million of royalty revenue.

Chinmay Shukla: Of course, we received the $75 million sales milestone slightly ahead of expectations. So we feel good about where things are, and we feel good about where things can be even better if the playing field gets leveled.

Speaker #3: And of course, we received the $75 million sales milestone slightly ahead of expectations. So we feel good about where things are, and we feel good about where things can be even better if the playing field gets leveled.

[Analyst] (TD Cowen): That is very helpful. Thank you very much for the call.

Nick Lorusso: That is very helpful. Thank you very much for the call.

Speaker #7: That's very helpful. Thank you very much for the call.

Operator: Your next question comes from the line of Josh Schimmer with Cantor Fitzgerald. Your line is now open. Please go ahead.

Speaker #4: Your next question comes from the line of Josh Shimmer with Cantor Fitzgerald. Your line is now open. Please go ahead.

Josh Schimmer: Great. Thanks for taking the questions. A question on capital allocation, but maybe in two parts. As you expand the Attruby sales force to address the long tail of subscribers, how do you think about the importance of acquiring another product to improve the efficiency of their calling efforts? Then, of course, there is a lot of chatter around the prospects of acquiring the outstanding ownership of GondolaBio to reintegrate that pipeline. How do you think about both of those potential opportunities?

Speaker #1: Great, thanks for taking the questions. I have a question on capital allocation, but maybe in two parts. As you expand the Atruvi sales force 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?

Speaker #1: And 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?

Chinmay Shukla: Yeah, Josh, thank you for the question. I will try and unpack some of this. I think we are very excited about GondolaBio's progress. They have a deep and exciting pipeline, and they have some very talented leaders running the company in James Morgan and Peter. Having said that, I think as Neil mentioned in his prepared remarks for BridgeBio, we are focused on execution here because we have a broad opportunity in front of us with Attruby, first of all, as you mentioned, 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. Obviously, being here in the Valley is very helpful for that.

Speaker #3: 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.

Speaker #3: They have a deep and exciting pipeline, and they have some very talented leaders running the company—James Morgan and Peter. Having said that, I think, as Neil mentioned in his prepared remarks for BridgeBio, we're focused on execution here.

Speaker #3: Because we have a broad opportunity in front of us with Atruvi, first of all, as you mentioned, trying to go after the long tail.

Speaker #3: 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.

Speaker #3: 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.

Chinmay Shukla: I think that is our big focus. I think we are also extremely focused on launching these next three products. I think that we have the opportunity to help a very large number of patients and really significantly grow our top-line revenues. Finally, I think that there is a lot of exciting pipeline activity at BridgeBio, both with the hypoPara phase III trial, which I think will read out in early 2028, as well as the antibody program, which we just announced today. We have just nominated a discovery candidate in which we think could be in the clinic not too distant of the future. So that is what we are focused on today. Maybe just taking a step back since you asked us our thoughts more broadly on capital allocation. First use of capital is operations and fully funding the operations.

Speaker #3: So I think that is our big focus. I think we are also extremely focused on launching these next three products. I think that we have the opportunity to help a very large number of patients and really significantly grow our top line revenues.

Speaker #3: And then finally, I think that there is a lot of exciting pipeline activity at Bridge, both with the hypopara phase three trial, which I think we'll read out in early '28, as well as the antibody program, which we just announced today.

Speaker #3: We've nominated a discovery candidate in which we think could be in the clinic not too distant of the future. So that's what we are focused on today.

Speaker #3: And maybe just taking a step back since you asked us our thoughts more broadly on capital allocation, first use of capital is operations and fully funding the operations.

Chinmay Shukla: 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. Second is to grow our pipeline, whether it is through M&A or through integrating our sister company, things like that. Third is buying back shares, which obviously, as the US saw in our Q, we bought back a few shares in September. The way we decide about it is, we look at what the IRR is on all these opportunities, 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. My hope is that this color helps you guys understand how the company will invest its capital.

Speaker #3: So 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.

Speaker #3: Second is to grow our pipeline, whether it's through M&A or through integrating our sister companies, things like that. Third is buying back shares, which obviously as you guys saw in our Q, we bought back a few shares in September.

Speaker #3: The way we decide about it is, we look at what the IRR is on all these opportunities, and we think about what our long-term shareholders will reward the most.

Speaker #3: 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.

Josh Schimmer: Great. Thank you.

Speaker #1: Great. Thank you.

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

Speaker #4: Your next question comes from the line of Beren Amin with Piper Sandler, your line is now open. Please go ahead.

Biren Amin: Yeah. Hi, guys. Thanks for taking my questions. Maybe another on the balance sheet. You have about $1.5 billion of cash and three product launches in the near term. How should we think about funding needs of Attruby and the new launches? Do you have what you need to get to profitability with the current balance sheet? Thank you.

Speaker #7: Yeah, hi guys. Thanks for taking my questions. Maybe another on the balance sheet. You've got about one and a half billion of cash. And three product launches.

Speaker #7: In the near term, how should we think about funding needs of Atruvi and the new launches? And do you have what you need to get the profitability with the current balance sheet?

Speaker #7: Thank you.

Tom Trimarchi: Hey, Biren, this is Tom. Good to hear from you. So, yeah, very strong balance sheet, as you mentioned, with $1.5 billion of cash today. I feel very comfortable with the cash that we need to continue executing on Attruby and to launch the next three products in a way that is disciplined, but a resource to win, certainly in these critical markets and these communities that we are trying to serve here. So, just piggybacking on Chinmay's earlier comment, I feel like operational cash needs are well covered by that $1.5 billion of cash. 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 are three quarters of the way through 2026.

Speaker #6: Hey Beren, this is Tom. Good to hear from you. So yeah, very strong balance sheet, as you mentioned, with 1.5 billion of cash today.

Speaker #6: 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.

Speaker #6: So just piggybacking on Chimai's earlier comment, I feel like operational cash needs are well covered by that 1.5 billion dollars of cash. And you can see that our cash flow from operations generally spent on a downward trajectory.

Speaker #6: Maybe to connect that a little bit with how we see the P&L evolving as well. So we're three quarters of the way through 2026.

Tom Trimarchi: I'm fairly confident that we'll average operating loss of around $90 million to $100 million a quarter this year. That's a big improvement from where we were at last year. That was about a $130 million loss a quarter last year. We were able to achieve this while ramping up sales and marketing spend for our coming three launches, really due to the fact that we're starting to see operating leverage show up in the Attruby brand. As we look forward to next year, I see a continued margin expansion from Attruby, and an improving operating line throughout the course of the year in terms of break-even point.

Speaker #6: I'm fairly confident that we'll average operating loss around $90 to $100 million a quarter this year. That's a big improvement from where we were at last year.

Speaker #6: 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 coming through launches, really due to the fact that we're starting to see operating leverage show up from the Atruvi brand.

Speaker #6: So as we look forward to next year, I see that continued market margin expansion from Atruvi and improving operating line throughout the course of the year towards a break-even point.

Tom Trimarchi: This is really going to take us into 2028, where we get to the place where all four of the brands have a chance to be profitable on an annual basis, and the P&L can really take a unique shape where we've got a very interesting and dynamic top line there with a very strong and evolving bottom line as well.

Speaker #6: 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 annual basis in the P&L can really kind of take a unique shape where you've got a very interesting and dynamic top line there with a very strong and evolving bottom line as well.

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

Speaker #4: Your next question comes from the line of Ellie Merle with Barclays, your line is now open. Please go ahead.

Ellie Merle: Hey, guys. Thanks so much for taking the question. I just wanted to ask about the Ascendis citizen petition on infigratinib. Can you address how you're thinking about that, and do you see any impact on the review timeline or on the label? 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.

Speaker #5: Hey guys, thanks so much for taking the question. Just wanted to ask about the Ascendus Citizens petition on Instagram. Can you address how you're thinking about that?

Speaker #5: 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?

Speaker #5: Thanks so much.

Chinmay Shukla: Hey, Ellie. Thank you for the question. It's great to hear from you. I'm going to pass this one on to Justin To, who leads the infigratinib franchise.

Speaker #6: Hey Ellie, thank you for the question. It's great to hear from you. I'm going to pass this one on to Justin To, who leads the Instagram franchise.

Justin To: Yeah. Thanks so much. 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 this citizen petition, 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 citizen petition mechanism, especially since they were just complaining about BioMarin 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 BioMarin and Ascendis saga that advocacy groups here and clinicians in this space care a lot about having choice. Ultimately, we believe that their hypocrisy will come back to hurt them here.

Speaker #1: Yeah, thanks so much. So first, we do not anticipate that this will impact the review timeline or label. I think there were a lot of false assertions and assumptions in the citizens position.

Speaker #1: And candidly, we think this tactic reflects how concerned they are about our independent launch. It's unfortunate they have to resort to a clear misuse of the citizens petition mechanism, especially since they were just complaining about Biomar doing the exact same thing to them about a year ago.

Speaker #1: We know the agency historically does not look favorably on petitions being used for competitive purposes. And we also know from the previous Biomar Incentive Saga that advocacy groups here and clinicians in this space care a lot about having choice.

Speaker #1: 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.

Justin To: Now, the concerns that they raised 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 inhibition of the target. Non-clinically, we conducted all the required tox studies with detailed CNS assessments, and this is required really for any program before you start a phase II study, let alone a phase III. In addition, we now have data out beyond 3 years showing that there are no CNS effects or really any AEs indicative of peripheral or CNS FGFR1 or FGFR2 inhibition. Remember, the agency has cleared us to go even younger in the infant and toddler program.

Speaker #1: First, the studies that they cite reflect full genetic knockout in mice, which everyone knows is very different than partial pharmacological inhibition of the target.

Speaker #1: Non-clinically, we've conducted all the required tox 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.

Speaker #1: 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.

Speaker #1: 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 spend the same amount of time and energy on generating data for their program.

Justin To: Really, at the end of the day, I think they and the physicians maybe would be better served if they spent the same amount of time and energy on generating data for their program. 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. I think this hasn't been a concern for us commercially.

Speaker #1: And when we speak to clinicians, they don't really kind of see this as a concern because they see the data that we have on hand.

Speaker #1: They understand really kind of the fallacy of the argument that's being made here. And so I think this hasn't been a concern for us commercially.

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

Speaker #4: Your next question comes from the line of Salim Sayed with Mizuho, your line is now open. Please go ahead.

Salim Syed: Great. Thanks for the question, guys. Congrats on the quarter. Just one from us on BBP-418, if possible. Obviously, it is a holiday PDUFA here. Can you just give us the logistics around it? What should we keep in mind as we head into the PDUFA, just given the holiday timing? 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.

Speaker #7: Great. Thanks for the question, guys. Congrats on the quarter. Just one from us on 418, if possible. So obviously, it's a holiday Padufa here.

Speaker #7: Can you just give us sort of like the logistics around that? What should we keep in mind as we head into the Padufa just given the holiday timing?

Speaker #7: 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?

Speaker #7: Thanks so much.

Chinmay Shukla: Hey, Salim. Thank you for your question. I am going to pass this one on to Anna Wade, who leads the neuromuscular franchise.

Speaker #6: Hey Salim, thanks for your question. I'm going to pass this one on to Anna Wade, who leads the neuromuscular franchise.

Anna Wade: Hi, Salim. Thanks so much for your question. I am pleased to say that we continue to have very positive interactions with the agency as they have been conducting their review. Given that continued engagement and feedback to date, we are confident that this will be a traditional full approval, and everything is looking on track for the 27 November PDUFA action date. We are excited about the potential, obviously, of BBP-418 to serve this LGMD2I community in a relatively major attempt.

Speaker #8: 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 I'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 Padufa action date.

Speaker #8: We're excited about the potential, obviously, for the 418 to serve as LGBTI community in the relatively near term.

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

Speaker #4: Your next question comes from the line of Andrew Sai with Jefferies, your line is now open. Please go ahead.

Andrew Tsai: Thank you. Congrats on the continued execution. On encaleret, 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 III study itself, what do you guys think is the fundamental efficacy bar for you to ultimately take meaningful share over your competitor? Thank you.

Speaker #9: Thank you. Congrats on the continued execution. On Calorips, 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?

Speaker #9: And then, as for the Phase 3 study itself, what do you guys think is the fundamental kind of efficacy bar for you to ultimately take meaningful share over your competitor?

Speaker #9: Thank you.

Chinmay Shukla: Hey, Andrew. Thank you for the question. I am going to pass it to Ananth Sridhar, who leads ADH1 and hypoparath for us to answer it.

Speaker #6: Hey Andrew, thank you for the question. I'm going to pass it to Anant Sridhar, who leads ADH1 and hypoparapharost to answer it.

Ananth Sridhar: Yes. It is a great question, and it is exciting to advance encaleret into this registrational study, the RECLAIM-HP study of encaleret in 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 hypoparath patients in the US 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 are seeing demand to be the strongest, it is amongst three cohorts. Chinmay actually had touched on these in our Q1 earnings call earlier this year. Those three populations are patients with persistent hypercalcemia. This is about 50% of the chronic hypoparath population.

Speaker #10: Yes, it's a great question. And it's exciting to advance in Calorip into this registrational study, the reclaim HP study of in Calorip 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.

Speaker #10: To directly respond to your question, we estimate around 200,000 prevalent chronic hypoparat patients in the US and Europe. Relative to ADH1, we estimate about 25,000 prevalent ADH1 patients in those same geographies.

Speaker #10: 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. In Chinmaya, actually I touched on these in our Q1 earnings call earlier this year.

Speaker #10: Those three populations are patients with persistent hypercalciuria. This is about 50% of the chronic hypoparat population. 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.

Ananth Sridhar: Secondly, it is 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. Finally, the third population is patients with injection site reactions or needle aversion. This represents about 40% of the population based on our estimates. These are the three cohorts that have expressed the strongest interest in our study. To your second question, what is the bar for success? We have a more stringent primary endpoint for this study, as has been seen in precedent studies and indications, as we are evaluating the concomitant normalization of both blood and urine calcium of encaleret relative to placebo.

Speaker #10: And then finally, the third population is patients with injection site reactions or neoaversion. This represents about 40% of the population based on our estimates.

Speaker #10: 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?

Speaker #10: We have a more stringent primary endpoint for this study as has been seen in precedent studies and the indication. As we're evaluating the concomitant normalization of both blood and urine calcium, of 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 hypoparathyroidism.

Ananth Sridhar: A 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 hypoparathyroidism.

Andrew Tsai: Very good. Thank you.

Speaker #9: Very good. Thank you.

Operator: Your next question comes from the line of Anupam Rama with JPMorgan. Your line is now open. Please go ahead.

Speaker #4: Your next question comes from the line of Anupam Rama with JP Morgan, your line is now open. Please go ahead.

Anupam Rama: Hey, guys. Thanks so much for taking the question. On 418 in Europe. Hold on. That is Kasimov messing with me. On 418 in Europe, you noted today that you are now planning on submitting an MAA in H1 2028 based on your interactions with health authorities. Can you give us some color on what came out in those conversations and what is driving that timing? How should we think about the EU opportunity in limb-girdle versus the US?

Speaker #11: Hey guys, thanks so much for taking the question. On 418 in Europe—hold on, that's Kazimov messing with me. 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.

Speaker #11: 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 Limgirdle versus the US?

Chinmay Shukla: Yeah. Hey, Anup. Thanks for the question. I will pass it on to Anna to talk about it.

Speaker #6: Yeah. Hey Anil, thanks for the question. I'll pass it on to Anna to talk about it.

Anna Wade: Thanks for the question, Anupam. Yes, these are based on multiple productive meetings we have 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 improvement from baseline in both ambulation and forced 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 is basically because they do not have the same regulatory flexibility in Europe as we do in the US. So what we are planning on doing is completing the ongoing 36-month study in H2 next year, and that data will be used to support the MAA filing, as you mentioned, in H1 2028.

Speaker #8: Thanks for the question, Anupam. So yeah, we these are based on multiple productive meetings we've had with EU national authorities. In those meetings, the feedback we're getting was they reiterated the compelling nature of the data that we were showing, with improvement from baseline in both ambulation and post-vital capacity.

Speaker #8: 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 US.

Speaker #8: So what we're planning on doing is waiting, 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.

Anna Wade: 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 US, and we are estimating over 4,000 patients currently in Europe with LGMD2I.

Speaker #8: 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 US, and we're estimating over 4,000 patients currently in Europe with LGBTQI.

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

Speaker #4: Your next question comes from the line of Derek Archilla with Wells Fargo, your line is now open. Please go ahead.

Derek Archila: 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 is early, but how should we frame that ramp, and what sort of KPIs are you willing to share as soon as, or soon after the launch starts? Thanks.

Speaker #11: Hey, good evening, and thanks for taking the questions. Maybe just staying on the Limgirdle theme here. As we think about the Limgirdle launch, how should we be thinking about modeling these first couple of quarters?

Speaker #11: 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 or soon after the launch starts?

Speaker #11: Thanks.

Chinmay Shukla: Yeah. Hey, Derek. Thank you for the question. I am going to pass it on to Anna to talk about this.

Speaker #6: Yeah, hey Derek, thank you for the question. I'm going to pass it on to Anna to talk about this.

Anna Wade: Thanks, Jumayn. Thanks, Derek. As we heard today, we are really excited about the LGMD2I launch and the potential benefit of BBP-418 that can provide this community. What is 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 hear from HCPs has been the cardiac data based on the fact that it is just 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. We are really feeling very good about the launch, and physicians have actually been contacting our medical team, letting us know that they are ready and waiting for the potential new therapy for LGMD2I.

Speaker #8: Thanks, Chinmaya. Thanks, Derek. So as you heard today, we're really excited about the LGBTQI launch and the potential benefits of these new 408s that can provide to this community.

Speaker #8: We're feeling really good about the ongoing preparations for launch. Interactions in the field continue to be very positive, and a recent medical meeting as well.

Speaker #8: The most requested data we'd hear from HCPs has been the cardiac data based on the fact that it's just such a key driver of morbidity and mortality in this disease.

Speaker #8: 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 from that four LGBTQI.

Anna Wade: As has also been mentioned, we have identified 500 unique genetically diagnosed patients to date, and we expect to fully penetrate that identified patient pool by year 3. As we go through the launch, we will be sharing what we are hearing from the field, and you can expect some more quantitative metrics to follow later, probably around the Q4 earnings call in early next year.

Speaker #8: As has also been mentioned, we've identified 500 unique genetically diagnosed patients to date, and we expect a fully penetrate that identified patient pool by year three.

Speaker #8: 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 early next year.

Chinmay Shukla: Yeah, I think just to build on that, Derek, we always communicate very transparently on launches. As you know, we did the same thing with acoramidis. So we are going to think about what are the right metrics which investors should look at. Then, as Neil mentioned in his prepared remarks, importantly, what is the right frequency at which we give those updates? 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 once we are out in the field. We are very excited for this opportunity to potentially help patients with limb-girdle muscular dystrophy type 2I.

Speaker #6: 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 our Truby.

Speaker #6: 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?

Speaker #6: So as we make those determinations, we will announce it. And but you can expect us to talk about it and to talk about how things are going once we are out in the field.

Speaker #6: We're very excited for this opportunity to potentially help patients with Limgirdle muscular dystrophy type II.

Derek Archila: Thank you.

Speaker #11: Thank you.

Operator: Your next question comes from the line of Danielle Brill with Truist. Your line is now open. Please go ahead.

Speaker #4: Your next question comes from the line of Danielle Brill with Truist, your line is now open. Please go ahead.

Danielle Brill: Hey, guys. Thanks for taking my questions. On infigratinib, I wanted to ask about hypochondroplasia. You mentioned the phase II/III ACCEL 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.

Speaker #12: Hey guys, thanks for taking my questions. On Instagram, I wanted to ask about hypochondroplasia. You mentioned phase two and phase three of cell studies, expanding to higher doses to find the optimal dose.

Speaker #12: 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?

Speaker #12: Thank you.

Speaker #6: Yeah, Danielle, thanks for the question. I'll pass it on to Justin.

Chinmay Shukla: Yeah. Danielle, thanks for the question. I will pass it on to Justin.

Justin To: Yeah. Thanks so much for the question. As a reminder, the purpose of our phase II study was to do a dose escalation to find the optimal dose. 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 AHV back to offset levels and showing stat sig or proportionality on ARM span. In hypochondroplasia, which is a different indication, the optimal dose may be different given the heterogeneity of mutations here and the different phenotypes that is seen.

Speaker #11: 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.

Speaker #11: Now, in a chondroplasia, we stopped at 0.25 milligrams per kilogram, not because of safety reasons, but because we hit the optimal efficacy level for that indication.

Speaker #11: For an AHV back-to-wild type levels, ensuring static and proportionality and arm span. In hypocondroplasia, which is a different indication, the optimal dose may be different given the heterogeneity of mutations here in the different phenotype that's seen.

Justin To: Given the clean safety profile that we have now seen in phase III long-term extension study, as well, of course, in our hypochondroplasia program, and the fact that we do not see any FGFR1 or 2 inhibition at these doses, we feel really comfortable exploring additional doses, and the agency has supported that decision as well. Ultimately, we are confident that we still have some distance from the top of the therapeutic index.

Speaker #11: And really, given the clean safety profile that we've now seen in Propeltary, long-term extension study, as well as, of course, in our hypocondroplasia 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.

Speaker #11: Ultimately, we're confident that we still have some distance from the top of the therapeutic index.

Speaker #4: Your next question. Your next question comes from the line of Jason Zamansky with Bank of America, your line is now open. Please go ahead.

Danielle Brill: Thank you.

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

Jason Zemansky: Good afternoon. Congrats on the great progress, and thanks for taking our question. Moving to the payer side, we are hearing a large player has started restricting first-line use of a competing silencer. Does this apply to Attruby? If so, which patients are affected, and what does the path to access look like? How should we be thinking about the impact on first-line starts and the risk of similar restrictions with other payers? Thanks.

Speaker #11: 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.

Speaker #11: 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?

Speaker #11: Thanks.

Chinmay Shukla: Yeah, I am going to pass it on to Mike to answer, Jason, and it is great to hear from you.

Speaker #6: Yeah, I'm going to pass it on to Matt to answer Jason as it's great to hear from you.

[Company Representative] (BridgeBio Pharma): Yeah. Hey, Jason Zemansky. I think we're probably talking about United here. United hasn't made any changes to Attruby in 2026. It made a change back in mid-2025 to prefer VYNDAMAX. But Attruby's been able to continue to grow since launch through all of this up till now. Our approval rates through appeal are over 90%, and Attruby continues to grow quarter over quarter. So there's really nothing new here for Attruby. It always, especially in the Medicare market, comes down to HCP and patient preference. And if an HCP wants Attruby, they can get it for their patients, and we've seen this since launch.

Speaker #11: Yeah. Hey Jason, I think we're probably talking about United here. United hasn't made any changes to a Truby in 2026. It made a change back in mid-2025 to prefer Venomax.

Speaker #11: But a Truby has been able to continue to grow since then, since launch through all of this up till now. Our approval rates through appeal are over 90%.

Speaker #11: And a Truby continues to grow quarter over quarter. So there's really nothing new here for a Truby. It always and especially in a Medicare market comes down to HCP and patient preference.

Speaker #11: And if an HCP wants a Truby, they can get it for their patients. And we've shown this since launch.

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

Speaker #4: Your next question. Your next question comes from the line of June Lee with UBS, your line is now open. Please go ahead.

Joon Lee: Hi. Thanks for taking our questions. We're really intrigued by the opportunity of encaleret in chronic hypoparathyroidism. As you enroll these postsurgical patients, are you tracking who has partial versus hemi versus total thyroidectomy? Our understanding is that different postsurgical patients may present with varying degrees of severity and may have a different responsiveness to encaleret. And related to that, what is your powering assumptions for the phase III RECLAIM-HP, and what is that based on? Thank you.

Speaker #11: Hi, thanks for taking our questions. We're really intrigued by the opportunity of in Colorado in chronic hyperparathyroidism. As you enroll these post-surgical patients, are you tracking who has partial versus hemiversus total thyroidectomies?

Speaker #11: Our understanding is that different post-surgical patients may present with varying degrees of severity that may have different responsiveness to encountering it. And related to that, what are your powering assumptions for the Phase 3 Reclaim HP, and what is that based on?

Speaker #11: Thank you.

Speaker #6: Yeah, hey June, thanks for the question and thanks for the deep work that you've done on our hypopatho program. Let me pass it on to Ananth to talk more about these questions.

Chinmay Shukla: Yeah. Hey, Joon. Thanks for the question and thanks for the deep work that you've done on our hypoPara program. Let me pass it on to Ananth Sridhar to talk more about these questions.

Ananth Sridhar: Yes. Thanks for your interest in the program. We share it. On your first question on whether we are monitoring for or assessing the extent of parathyroid tissue loss as a result of surgery or anterior neck injury, it is really hard to assess that. Sometimes tissue is left in situ, but it loses vascularization and hence function. What we are going to be measuring at baseline, similar to other analog studies, is the extent of PTH concentrations in blood calcium and urine calcium at baseline, and we will obviously assess longitudinal changes on or off treatment. In terms of powering assumptions, we have randomized the study 3 to 1. We powered the study to assess for a differential clinical benefit on achieving concomitant normal blood and urine calcium.

Speaker #11: 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 surgery or anterior neck injury, it's really hard to assess that.

Speaker #11: Sometimes tissue is left in situ, but it loses vascularization and hence function. What we are going to be measuring at baseline, similar to other analog studies, is the extent of PTH concentrations in blood calcium and urine calcium at baseline.

Speaker #11: And we'll obviously assess longitudinal changes on or off treatment. In terms of powering assumptions, we are powered so we have randomized a study of three to one.

Speaker #11: We power the study to assess for a differential clinical benefit on achieving concomitant normal blood and urine calcium. And as a reminder, we inform these estimates based on what we saw in our proof of principle phase two with some more conservative estimates.

Ananth Sridhar: As a reminder, we informed these estimates based on what we saw in our proof of principle phase II 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 encaleret within 5 days. So we have obviously taken some steps to be more conservative in our powering assumptions, but those signals from that study helped inform our powering estimates.

Speaker #11: And that study, we saw that none of the patients achieved that primary endpoint on conventional therapy. Whereas 80% achieved that profile on encounter it within five days.

Speaker #11: 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.

Speaker #4: We have reached the end of the Q&A session. I will now turn the call back to Pablo Elvira for closing remarks.

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

Pablo Elvira: Thank you everyone for joining us for our Q3 earnings call today. We appreciate your interest, and we look forward to updating you again next quarter.

Speaker #11: 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.

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