BridgeBio Pharma, Inc.

Good afternoon. I will be your conference operator today. All lines have been placed on mute to prevent any background noise. After the company's remarks, there will be a question and answer session. If you would like to ask a question, press star followed by the number one on your telephone keypad. If you'd like to withdraw your question, press star one a second time. Before we begin, I would like to remind everyone that today's call may contain forward-looking statements within the meaning of the federal securities laws, including, but not limited to, statements about BridgeBio's future operating and financial performance, business plans and prospects, and strategy. These statements are based on current expectations and assumptions that are subject to risks and uncertainties, which could cause actual results to differ materially from those expressed or implied in these forward-looking statements. For a discussion of these risks and uncertainties, please refer to the disclosure in today's earnings release and BridgeBio's periodic reports and SEC filings. All statements made here are based on information available to BridgeBio as of today, and the company undertakes no obligation to update any forward-looking statements made during this call, except as required by law. With that completed, BridgeBio, you may begin your conference.

Good afternoon, everyone, and thank you for joining BridgeBio Pharma's third quarter 2025 earnings call. I am Chidmay Shukla, Senior Vice President of Strategic Finance at BridgeBio. With me today are Neil Kumar, our CEO, who will provide opening remarks and discuss overall corporate performance, Matt Outen, our chief commercial officer, who will provide more details about our commercial performance, particularly the continued success of Atruby, and Tom Tremarcki, our president and CFO, who will review our financial results. During today's call, we'll cover our strong commercial execution in Atruby's third quarter on the market We'll provide updates on our late stage pipeline, including the phase three readouts of Encallerate and BBP418, which were announced this week, as well as discuss Infragratinib and achondroplasia, which we expect to read out in early 26. We will end with a discussion of our robust financial position. Following our prepared remarks, we will open the call for Q&A. For the question and answer session, we will also be joined by Anant Sridhar, Anna Wade, and Justin To, who lead NCALRET, BBP418, and Infogratnib, respectively. With that, I'll turn it over to Neil for his remarks.

Thank you everyone for joining us today. As always, this is a forum in which we communicate salient aspects of our business that are of interest to investors, and we welcome your questions and feedback along the way. On the first two of these calls we've done, I focused my early comments on Atruvi, which continues to be the core of our business. As both Matt and I will elaborate on, we see continued momentum both scientifically and commercially in this franchise and are ever more confident today that we will achieve our goal of 30 plus percent market share by volume in the years to come. But I wanted to start today by talking about our recent R&D progress. As you all know, we had the distinct privilege of announcing two stellar phase three top line results over the last three days. It is quite the coincidence that these readouts happen to stack on top of one another after six plus years of working on these programs. But these few days serve as a testament to the longer term productivity of the R&D engine we've created. Slide 10 of our updated corporate presentation shows the industry leading timelines that we've been able to achieve. And slide 11 shows the remarkably high probability of technical success across our programs, across the nearly 10 years that we've been operating. Probabilities of technical success north of 70% start to move us from a lottery ticket like entity to an engineering company like entity. One that will undoubtedly face failure, but that can reliably produce medicines that matter with reasonable cadence. The speed and efficiency of the Bridge Bioengine is only possible because we target well-described genetic diseases at their source. It's also the product of our decentralized hub-and-spoke model that is fueled by our tireless employees that are dedicated to making an impact to the patient communities that we serve. I'd now like to highlight some of the most remarkable aspects of the data we have shared over the last few days and encourage those seeking to learn more to access our webcasts on each readout. On Monday, we read out our Phase III Fortify trial of BBP418 in limb girdle muscular dystrophy type IIi. The study exceeded all of our expectations, meeting all primary and secondary interim analysis endpoints. The primary endpoint, glycosylated alpha-dystroglycan, was successful to a high degree of statistical significance. Though even small changes in ADG have been shown to be clinically meaningful, it is remarkable to see some patients attaining normalized levels of ADG. And the 80% increase in glycosylation meaningfully moved patients to healthier levels of muscle function. Across the key clinical endpoints studied, ambulatory function and pulmonary function BBP418 not only stopped the decline that was seen in the placebo, but showed a statistically significant incline in function. Patients are walking better and breathing better than when they started. In addition, this small molecule is distributed systemically, and we look forward to sharing additional data associated with its impact on other tissues, including, importantly, the heart muscle. Earlier today, we shared the top line data from our phase three Calibrate trial of incalorate in autosomal dominant hypocalcemia type one. We saw profound and highly statistically significant normalization across blood and urine calcium, as well as highly statistically significant normalization of PTH. Just to reiterate, a vast majority of patients fully normalized urine, serum, and PTH levels. As I mentioned on the webcast, when we speak of cures in therapeutic medicine, this is the type of impact we seek. And as I mentioned on our last earnings call, we are moving expeditiously not only to launch this drug, but also to initiate its phase three in chronic hyperparathyroidism. Here, Incalora and a cohort of 10 patients normalized urine and serum calcium in 80% of subjects within five days of dosing. Importantly, this drug brings differentiated promise to the hyperparathyroidism community across at least three potential dimensions. First, it's oral. Second, it potentially normalizes urine calcium, the cause of downstream kidney conditions. And third, it might avoid potential downstream bone-associated resorption issues that could require bisphosphonates. Finally, and importantly, for both small molecules in LGMD2I and ADH1, we saw a safe profile, supporting their ability to provide lifelong improvement for patients who have no disease-modifying therapies available today. Of course, these data are only interesting to the extent that we can get the therapies into the hands of patients. This is where the ongoing success of Atruby gives me confidence that we can distribute at scale. We have been in the marketplace for nearly a year, and I feel our message is just beginning to resonate. The numbers to support that include the fact that we have delivered 5,259 unique patient prescriptions to 1,355 unique HCPs, generating this quarter 108.1 million in net product sales In the long term, although our goal is 30% to 35% share by volume, I believe we have the potential to be a market leader. The best point estimates to date on key endpoints at the lowest price point backed by an aggressive research plan support that future. Early performance of BioNTech in Europe, where physicians have been quick to recognize the strength of our data, also supports that future. Our partners at Bayer have done a wonderful job prosecuting the Akaramidis hypothesis in Europe, closing in on market leadership in Germany with an MBRX of nearly 50 percent just six months into launch. In that geography, among other tailwinds, regulators have also been quick to shut down Pfizer's inaccurate claims of, quote, near complete stabilization. On that topic, as I was putting together my comments, I stumbled upon an old email that Dr. Jeff Kelly, the inventor of tefamidus, had sent to Dr. Isabella Graif, one of the inventors of acarambis. In it, and I directly quote him, he says, given the variability in stoichiometry and the experiments between tefamidus and AG10 and TTR, the data always tell the same story, that AG10 is better than tefamidus, as would be expected from the determined binding constants. I have to say, I agree with him. Moving on from competing, we are also asking ourselves, what is unique about our product? As many of you know, in patients with cardiac arrhythmic involvement, we observed a 43% reduction in risk of CVH associated with cardiac arrhythmia and a 17% reduction in TEAEs related to new onset AFib. That is unique. In patients with the most common variant, V122I, we published a 59% hazard reduction, which to our knowledge is the largest point estimate in terms of reduction demonstrated in the field. We expect to further elaborate on these data at the upcoming AHA conference, so please stay tuned for that later this weekend. Additionally, we've continued to interrogate what in my mind is an incredibly unique factor, our early time to separation. In a recent Jack paper, We published that the effect of acramidus on recurrent and cumulative cardiovascular outcomes was observed as early as one month. One question is, why is this prompt effect occurring? One hypothesis is that the answers may reside in the cardiorenal axis, similar to what has been described for SGLT2 inhibitors, and we intend to explore this further in the clinic. In addition, we intend to bring a new clinical CMR study to the field to further interrogate Atrupe's impact on disease regression as measured by cardiac function and structure. Some of you may have seen another single-site CMR study recently published by Zlibet et al., in which they suggest the, quote, potentially superior effect of acaramidus, end quote, versus defamidus on important parameters like LVEF and LVMAS. These new research areas marry nicely with the continued execution of our ACT early trial, a potentially profound study that explores the effect of acaramis in pre-symptomatic variant patients and in the context of this mass action disease. Finally, we'll continue to study the efficaciousness of the drug in the context of real-world evidence studies. We've been proponents of leveraging RWE as early as the survival studies done by Drs. Masri, Moore, and others. Given that in the modern marketplace, it is an exceptionally difficult thing to conduct double-blind head-to-head studies, RWE will serve as an important tool in identifying the right patients for the right drug. And we'll have more to publish on this front in the months to come. These research efforts tie together with the continued strengthening of our access profile and increasing diagnosis rates of patients with ATTR cardiomyopathy. Matt will have more to say about our access program but we continue to offer best-in-class programs and are improving with every month the ability to, quote, make it easy for those patients and physicians that desire access to a Truby. I'll end with a brief comment on future growth. The obvious growth in our portfolio today sits with the expansion programs of hypochondriplasia and in chronic hyperparathyroidism, branching from our achondroplasia and ADH1 programs, respectively. But shareholders should not overlook the deep ownership and close oversight we have with our sister companies. At Gondola Bio in particular, we now have 17 programs across the Mendelian landscape, including what we believe to be a potentially best-in-class asset in EPP in phase two and buttressed by exciting programs in alpha-1A trypsin deficiency, hereditary pancreatitis, ADPKD, and many other areas. As these programs move forward and we continue to solidify Bridge Bio, we can access new growth opportunities at the right time to increase the scope of work we are doing for patients. With that, I'll turn it over to Matt, our Chief Commercial Officer.