BridgeBio Pharma, Inc. Common Stock 2026 Q2 Earnings Call

Good afternoon, everyone, and thank you for joining BridgeBio Pharma's second quarter 2026 earnings call. I am Chinmay Shukla, Senior Vice President, Strategic Finance. With me today are Neil Kumar, our CEO, who will walk through our commercial pipeline and business updates, Matt Outten, our Chief Commercial Officer, who will provide additional detail on Attruby and our launch readiness, and Tom Trimarchi, our President and CFO, who will review our financial results. During today's call, we will cover another quarter of consistent growth for Attruby, along with new data reinforcing its clinical differentiation, including the first evidence of direct kidney protection in ATTR-CM. We will then turn to the pipeline, where this quarter, all three of our late-stage programs moved from data into being with the FDA, with our first PDUFA date now set for November 27.

And we will review our financial position, including the $1 billion preferred equity financing completed on July 1, and how it supports the three launches ahead of us. Following our prepared remarks, we will open the call for questions. For the Q&A session, we will be joined by Ananth Sridhar, Christine Xu, and Justin To, who lead our programs with encaleret, BBP-418, and infigratinib respectively. 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. In sessions past, we've had occasion to marry comments on the portfolio with comments regarding financing and strategy. Today, however, I want to focus entirely on the portfolio itself and the progress being made across research, development, and commercial. I'm going to do so because I believe, as I hope you might appreciate at the end of my somewhat lengthy comments, that this is an important transition point for BridgeBio, one in which, if we continue executing at a high level, sets us up well for delivering substantial returns for patients and investors alike. Put more simply, it feels like we're at T equals zero in BridgeBio's next chapter.

I don't say this glibly, but rather due to the following and overlapping advances. First, as we will discuss, the combination of learnings from CARDIO-TTRansform, our own unique kidney-protective data, and extraordinary real-world evidentiary results come together to provide the basis of what I'm calling Launch 2.0 for Attruby. I believe we will start to see significant commercial fruit from this in the 6-9 month range and beyond, judging from analogs. We think the market is shaping up to be a stabilizer-first market with a constrained number of competitors and one in which we have increasing numbers of proof points that our near-complete stabilizer is superior to Pfizer's partial stabilizer. Second, all three NDAs for LGMD2I, ADH1, and achondroplasia have been submitted, with LGMD2I and ADH1 garnering priority review and are hoping that achondroplasia might too.

Our commercial readiness work is on track, even ahead of what we were able to do with ATTR cardiomyopathy, given our relatively lean resourcing at the time to deliver strong launches. Third, our chronic hypoparathyroid phase III, which we believe is overlooked, has commenced and will read out in the next 18 months with potential to provide a differentiated efficacy and safety profile as we will discuss, in addition to being the only oral in the space. Finally, we anticipate novel trials in areas like Turner and hypochondroplasia for infigratinib, a new trial in a to-be-disclosed hyputinuric orphan kidney disease for acoramidis, and the advancement of a potentially best-in-class TTR antibody into the clinic in the coming 12-18 months. All of this activity together provides a substrate for well over $10 billion in risk-adjusted revenue, with $8 billion of that being post phase III to date.

In addition, our interest in earlier but still advanced genetic medicine R&D within our GONDOLA pipeline continue to bear fruit, so this is a company with no dearth of pragmatic ideas that can drive a continued flux of important medicines on a risk-adjusted basis for the next decade or more to come. I'll begin my portfolio comments with Attruby. First and most importantly, we observed continued commercial momentum this quarter, with Attruby being the fastest-growing brand in the space at 23%, and this growth does not account for the impacts of CARDIO-TTRansform, our kidney data, and most of the real-world evidence data to date, since that occurred after the quarter end. We've always said that the most important thing commercially and medically in this whole space is diagnosing new patients.

To that end, we were heartened to see the substantial overall market growth of 19% this quarter, representing a 51% increase year-on-year and substantially outstripping the market growth observed in the last three quarters. Consistent with these numbers is the growth in frontline patients, where stabilizers have dominated share, a trend that we think will strengthen as we learn more from CARDIO-TTRansform's important results. Indeed, we observed a slight downtick in numbers of second-line patients in the second quarter. We believe our share in frontline has grown some 2-3 percentage points, although it's hard to tell precisely given some of the inventory dynamics from our competitor, Pfizer. Our gross profit also remains within the 30%-40% that we have indicated previously.

Going forward, we expect that the first-line market will continue to grow, and we intend to continue growing our share in it, which should translate into continued steady sales growth. Attruby's strongest tailwind, however, is its continually growing clinical differentiation story, driven for the most part by the expanding body of real-world evidence, as well as the now documented renal protective effect. In July of this year, we published in Circulation: Heart Failure on acoramidis, driving the first ever early and sustained direct kidney protective effects in ATTR cardiomyopathy, including chronic eGFR slope improvement and urinary albumin to creatinine ratio reduction. The upshot of this is that Attruby may protect the heart and the kidney simultaneously in ATTR patients, a hemodynamically mediated effect which we do not observe with other ATTR cardiomyopathy medicines, either knockdowns or other stabilizers.

Critically, as pointed out in the paper, the dynamics of this effect mirror the early separation uniquely observed with Attruby in terms of clinical outcomes, helping to explain this early impact. Furthermore, and intriguingly, the magnitude of the acute dip in eGFR on Attruby is actually important and suggestive of downstream benefit. More specifically, comparing acoramidis versus placebo subgroups with acute eGFR dips greater than or equal to the median of 4.89 mil per meter per 1.73 meters squared favored acoramidis for all-cause mortality or cardiovascular-related hospitalization with a whopping hazard ratio of 0.42 with an associated P value of 0.006 and cardiovascular-related hospitalization alone with a similarly impressive hazard ratio of 0.34 with an associated P value of 0.002. Intriguingly, within the placebo arm, eGFR dips portended worse outcomes. So something initially thought to be a crutch has now been shown to be an important differentiator for our product.

The observed effect compares favorably to what we see in other kidney protective cardiac treatments like SGLT2 inhibitors. In a recently held meeting of nephrologists and cardiologists, one KOL explained to me, "It looks like you have a kidney drug here." Building on that, as referred to above, we intend to further interrogate this signal by conducting clinical studies in an orphan kidney indication. More information on that in the weeks to come. Meanwhile, the generation of real-world evidence continues apace. When one looks at analogs in the cardiovascular space where double-blind head-to-heads were not immediately possible, real-world evidence sets the bedrock of ultimate commercial outperformance. The most storied of these analogs is likely the ELIQUIS/Xarelto marketplace. Calling back to last quarter, there was an independent propensity score-matched analysis presented at SCAI and since published, which continues to resonate with physicians.

That analysis associated Attruby with a 37% reduction in composite cardiovascular events and a 34% reduction in hospitalizations at six months relative to tafamidis, with an effect deepening at nine months. Remarkably, there was no observed clinical outcome that did not favor Attruby versus Vyndamax in all measures except for dizziness and syncope, reached statistical significance of less than 0.01 with an N just shy of 600 patients. Building on this data, we have our own now soon to be published and available online today preprint analysis that parenthetically has been downloaded more than 400 times now, showing again Attruby outperformance as compared to Vyndamax. Importantly, in this study, a 34% reduction in diuretic intensification, heart failure hospitalization, and mortality was observed, again, statistically significantly, and separation is again observed as early as 30 days and continues to improve over time.

These types of analyses are what the community has been asking for. Importantly, a large-scale independent EHR-based analysis will be coming at HFSA. Our hope is Attruby continues to perform well there, and that then these several RWE studies will form the basis for decision-making and guideline updates. The growing body of research supporting Attruby's clinical differentiation will take place alongside evidence from other studies in this rapidly evolving field of ATTR cardiomyopathy. Last month, as you all know, the top-line results for CARDIO-TTRansform studying eplontersen in ATTR cardiomyopathy read out, and the study did not meet its primary efficacy endpoint with no benefit observed with combination therapy. At this point, we mostly want to acknowledge that this is a blow to the patients who participated in the trial and their families and the investigators, and we feel for them as part of the ATTR cardiomyopathy community.