BridgeBio Pharma, Inc. (BBIO) Earnings Call Transcript & Summary

All right. Well, thanks for joining the webcast. I've been waiting to say these words for a very long time. I'm pleased to announce today the approval of Attruby or as many of you have known it, acoramidis for the treatment of patients with ATTR cardiomyopathy. I want to begin my comments today where I always begin my comments on acoramidis, which is with a profound and sincere thank you. A thank you to the patients who bravely and courageously entered our clinical trials with the belief in the potential for better clinical care. You made it possible for us to deliver on the promise of Attruby. And in turn, we understand our responsibility spans much further than the science and medicine of ATTR cardiomyopathy. Importantly, you'll be hearing later today from Matt Outten, our Chief Commercial Officer, on the many programs that we have put in place to take this already least expensive drug product and make sure that anyone who needs access to it can gain access to it. Furthermore, as a small thank you to the patient community, any patient that was involved in our Phase III clinical trial will receive free drug for life. Secondly, I'd like to thank the physicians and KOLs that partnered with us on this journey that was at times turbulent. Your belief in the thesis that ever better levels of stabilization can lead to ever better clinical outcomes was what allowed us to bring Attruby to the starting line today. In turn, we also understand that our responsibility to you expands even beyond that which we were doing for patients and includes furthering the science and medicine of this field. Our trial, at early, our primary prevention study is just one example of what we hope to partner with you on in the years to come as we learn more about for which patients, at what time these therapies are best taken. Finally, I want to thank the scientists and academics that really pioneered this field and broke open the path of mechanism and blueprint of this condition. It was your understanding of genotype, phenotype, your identification of the trans-allelic trans-suppressor and your identification of chemistries that phenocopied that rescue mutation that allowed BridgeBio to get started in its therapeutic adventures in this space. All of that early science has paid off beautifully in today's approval of Attruby. Finally, I'd like to thank my partners here at BridgeBio, who have worked tirelessly on this program for almost a decade. I look forward to continuing to work with you shoulder to shoulder as we advance Attruby into the marketplace and make many more advances in this field and others in the years to come. Before I pass it over to Matt, I wanted to take a moment and discuss some of the salient features of the label that Attruby has received. First and foremost, this is the only oral stabilizer with the verbiage near complete stabilization in the label. Almost all the benefits that are described downstream in the label stem from this near complete stabilization. As early as 3 months, the earliest time point that we know of, this medicine begins to take action against the composite point of cardiovascular hospitalization and death. At 30 months, we observed a 42% relative risk reduction against hospitalization and death. And that is associated with a 50% reduction in cardiovascular hospitalization alone. This impact, against these key clinical outcomes is profound and couples nicely with our understanding that ever better stabilization which leads to ever lower levels of toxic monomer deposit in the heart, greatly reduce or actually improve elements like anti-proBNP or serum TTR and that those in turn are predictive and result in benefits that you can see in mortality, that you can see in hospitalization and you can see in key measures of quality of life such as Kansas City Questionnaire and 6-minute walk distance. BridgeBio was founded almost 9 years ago as a new type of biopharmaceutical company, one that could bridge the gap between early science and medicines that matter for patients suffering with genetic conditions, a new type of company that could serve both large markets and small markets together. Today, with our third approval, the first large market approval that we've had, we hope we've taken another step in validating our model. With that, I'd like to turn it over to Matt Outten, our Chief Commercial Officer, who will tell you more about the programs we have designed to improve access for the patients that we serve. Thank you.

Thanks, Neil. I want to echo your comments and thank the patients, caregivers, health care providers and scientists who made the approval of Attruby possible. There is tremendous unmet need in the ATTR amyloidosis space for newly diagnosed patients as well as for those patients progressing on current medications. The approval of Attruby will help patients in the U.S. reach their treatment goals. When we started planning for the approval of Attruby, we had 2 goals at BridgeBio. Number one, help doctors and patients get started on Attruby. They needed to do it quickly and easily. And number two, make Attruby more affordable for all patients. Today, we are excited to share some of our many new patient programs and our all-new forgingbridges.com website. While I won't be going into all of the programs we are initiating on today's video, I did want to touch on a few. Fast delivery. Any patient who is new to Attruby can now receive Attruby within 48 hours. This includes newly diagnosed patients or patients who wish to switch from their current medication. Examples of patients who may benefit from this program include a patient who has recently been diagnosed with ATTR-CM, patients whose disease is progressing on their current medication. We know that as many as 20% to 40% of currently treated patients may be progressing on their current ATTR cardiomyopathy treatment, patients who have seen their diuretic use increasing over time, patients whose lab work is going in a negative direction, that could be someone whose serum TTR levels, for instance, were not where they'd like them to be, patients who have been admitted to the hospital for heart problems while on their current medication and patients taking Crestor. In addition to the above, we are proud to share that for uninsured or underinsured patients, BridgeBio is announcing today the most generous free goods program available in ATTR-CM, which will help eligible patients obtain Attruby for a cost of $0. In addition to the most financially generous qualifications currently offered, the Attruby program allows for appeals due to life changes and other circumstances, the only program to do so in ATTR-CM. Our patient assistance program is also open to commercially insured patients, the only program to do so in ATTR-CM. Finally, with today's approval, Attruby is the least expensive approved drug on the market, treating the underlying causes of ATTR-CM. And because Attruby is the only approved medication that reduces cardiovascular-related hospitalizations by 50% at 30 months, it, in effect, should reduce the expense of treating these patients. And while that is important, the list price of a medication is not what patients pay. Let's talk about what a patient's out-of-pocket cost will be for Attruby. Many patients will pay $0 per month. This includes commercially insured patients who use the BridgeBio $0 co-pay card and for Medicare patients who have reached their out-of-pocket maximum. In general, Medicare Part D patients will pay a maximum of $167 per month. This is the maximum amount of out-of-pocket costs regardless of how many Part D or oral medications the patient is taking. This is important because the average patient with ATTR-CM is on 8 to 9 medications. Approximately 30% of the ATTR-CM population is known as dual eligible Medicare Medicaid, and they will pay no more than $12 per month. I wanted to list out the above as it can be confusing for patients when it comes to out-of-pocket costs and how much the true cost of a medication is for patients and the health care system. That is before we add in the additional costs of hospitalization, not to mention the impact on a patient's quality of life. BridgeBio has information and live representatives available to help patients on Attruby understand these topics and individuals can go to the following locations to get information. You can go to attruby.com, forgingbridges.com or you can call 88855Bridge. We look forward to being able to serve patients after many years of planning and hard work. We're happy to celebrate today's approval of Attruby with you, and we will speak again soon. Thank you.