BridgeBio Pharma, Inc.

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

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

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