BridgeBio Pharma, Inc. Common Stock 2026 Q3 Earnings Call

Chinmay, please go ahead. Good afternoon, everyone, and thank you for joining BridgeBio Pharma's third quarter 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 February 4, with priority review, and the PDUFA date for encaleret is May 8, 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.

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.

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 U.S. 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.

This is coupled with an ever-evening playing field in the U.S., a consequence of Attruby'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 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.

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.

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.

There is 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 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.

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.

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.

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 set the bedrock of ultimate commercial performance.

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 U.S. 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.

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 U.S. This is a contemporary cohort, patients from 2025, and it is the first EHR-based comparison of the two 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.