NASDAQ:BBIO BridgeBio Pharma Q1 2025 Earnings Report $38.12 -0.45 (-1.15%) As of 10:45 AM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings HistoryForecast BridgeBio Pharma EPS ResultsActual EPS-$0.88Consensus EPS -$1.00Beat/MissBeat by +$0.12One Year Ago EPS-$0.20BridgeBio Pharma Revenue ResultsActual Revenue$36.74 millionExpected Revenue$57.14 millionBeat/MissMissed by -$20.41 millionYoY Revenue Growth-44.80%BridgeBio Pharma Announcement DetailsQuarterQ1 2025Date4/29/2025TimeAfter Market ClosesConference Call DateTuesday, April 29, 2025Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by BridgeBio Pharma Q1 2025 Earnings Call TranscriptProvided by QuartrApril 29, 2025 ShareLink copied to clipboard.PresentationSkip to Participants Operator00:00:00Afternoon. 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. Thank you. Operator00:00:21Before 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. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:01:38Good afternoon, and thank you for joining BridgeBio's q one twenty twenty five earnings conference call. This is Chinmay Shukla, VP of Strategic Finance at BridgeBio. Today, we will discuss our financial results for the first quarter of twenty twenty five and provide an overview of how we measure success in our business. We'll provide insight into the early results from the launch of Atruby as well as provide an update on our pipeline, which has three Phase three readouts expected in the next year, including our efforts in expansion indications such as in chronic hypoparathyroidism. Today's call will feature Neil Kumar, Chief Executive Officer Matt Houghton, Chief Commercial Officer and Tom Tremarki, President and Chief Financial Officer. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:02:22For the Q and A portion of the call, Anant Shreedhar, Chief Operating Officer of BridgeBio Cardio Renal and Justin Toh, Chief Executive Officer of BridgeBio Scheduled Dysplasia will also join. Following the remarks by our team, we will open up the call for Q and A. With that, I'll turn the call over to Neil. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:02:42Thanks to everyone on the line for the time and welcome to our first earnings call. We're grateful to open up another dimension of our dialogue with our investor partners. You collectively allowed us to deliver for the patients we serve and we look forward to your feedback on how to continually improve our discussion in this setting. Today, we know the star of the show is the Atruvio launch and the good news is that the brand is delivering for patients and the business. Dollars 36,700,000.0 in revenue this past quarter suggests that clinicians and patients are resonating with our differentiated clinical efficacy, safety and accessibility. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:03:18We continue to educate on our therapeutic impact, which comes as early as three months with a forty two percent relative risk reduction on cardiovascular hospitalization and mortality at thirty months, including a fifty percent reduction in cardiovascular hospitalization at that same time point. All these best in class point estimates are available at the lowest price point in the marketplace. There is much to like there. And we're aware that there is much work yet to be done. You'll hear about some of that work today as it pertains both to commercial tactics and further development work. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:03:51We add to Atrubia's good news the continued progress across our pipeline of three additional blockbuster products. Our trials in Limb Girdle Muscular Dystrophy Tab II, achondroplasia and ADH1 remain on track with low dropout rates, frequent data collection and positive site audits, all in preparation for an efficient NDA submission should the data be positive. Furthermore, key additional markets are being opened up. Our hypochondroplasia trial enrolled with incredible speed and we now have first patient in there. Our work with Incalorate in the hypothyroid setting positions it well for registrational trial, which if successful could pave the way for the first oral compelling solution in that space. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:04:33Before we move to discussion into further specifics regarding the business and since this is our first time hosting this type of call, I wanted to briefly address how we measure the performance of our business on an ongoing basis. It's nice that this quarter was a success, but there will be harder quarters I am sure. And through it all, you should expect for us to communicate consistently and in terms of net gains or losses in NPV. For instance, in this last quarter, our NPV increased by 9% given changes in the following variables: number one, the time factor of money, especially given the late stage of our portfolio number anticipated revenue driven by faster uptake of Atruvio than we anticipated and likely a slightly higher peak year share by volume than our market research had projected third, the success of our small study in HP and other sponsor setbacks in the space of oral HP medicines fourth, the early enrollment of our run-in of our hypochondroplasia study moving our timelines in for that program And fifth, a slight decrease in our model cost of capital given our recent convertible offering. There were NPV drags most prominently including tariffs. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:05:46However, these have a close to negligible effect at less than 1% of our overall NPV. Stepping back from NPV and as a reminder, our overall objective here at BridgeBio is simple, to maximize the positive change we can have in terms of quality adjusted life years for the patients that we serve as quickly as possible. We do so by creating as many meaningful medicines as possible as quickly as possible within three constraints. The first is that each program must have beautiful science, which in our vernacular means a high POTS driven by understanding a mechanism of disease optimally paired with a therapeutic mechanism of action that targets a well described genetic condition at its source. These types of programs historically have a three to four times higher probability of technical success than all comer drug R and D efforts. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:06:35Over time, in many programs, this elevated probability of technical success moves us from being a speculative lottery ticket to being something akin to an engineering company. The second constraint is that we strive for each medicine that we make to be first in class or best in class. Determining best in class can be tricky in the absence of double blind head to heads, but we approach this using a straightforward Bayesian approach. For instance, in TTR, if faced with decision as to what drug to use, a logical person would first interrogate the salient endpoint, death and hospitalization at a common time point. In this case, at thirty months, a relative risk reduction of forty two percent is a better point estimate as compared with any of the other products in this marketplace. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:07:20You would then ask how quickly does each drug take action? And you would find that the three month beginning of separation between placebo and active is the earliest point estimate of timing of impact in this field. So logically, BETRUVY is at worst no worse than other medicines. You would then look at safety. Here you would find little difference between small molecules but would observe that they do not have the safety signals some knockdowns have. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:07:47Vitamin A deficit, which by the way turns knockdowns into a once daily pill regimen, injection site reactions, the absence of impact on AFib, whereas both small molecules had meaningful reductions there, The imbalance of cardiac SAEs is observed in the INPATRO study and the as of yet unexplained imbalance in death on the rivusiran trial. You couple that with the overall finding that across multiple studies, TTR is a cross species conserved protein and that ever higher levels of TTR lead to ever longer lives and less disease over time. So logically, small molecule stabilization from these data is the safest approach. Finally, the logician might look at price only to discover that Etruevi has the lowest price point. We believe, given all of that, the choice is clear. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:08:39We apply similar reasoning in other competitive spaces like achondroplasia. Our final constraint is that each program we work on should be NPV positive to ensure firm level sustainability. We use all available levers during the R and D stage to optimize NPV, including time, cost, cost of capital and probability of technical success. The better our model is at generating economic value from projects, the further we can push into markets where others cannot extract adequate value in addition to being a better owner of obviously NPV positive projects. The fact that we will spend well under $100,000,000 per program to get each one of our potential blockbusters from the preclinical stage through proof of concept sets us up well for future growth that is economically attractive. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:09:28Okay. So that's our overall objective function with its intended constraints. And you heard the first and most important frame that we use to think about the business, which is NPV. There are other frameworks that we also use to look at the business, understanding the business by stage and capability, research, development and commercial, understanding the business in the context of the overall ecosystem, and understanding the business program by program. Using the by stage framework first, and as I mentioned earlier, we are pleased with the ongoing progress of our commercial launch and the building of a sustainable competitive advantage there, which means of course that our group is able to extract more profit from the asset than another would be able to. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:10:11I've also touched already on our ongoing development wins. On Discovery, our bread and butter, we continue to advance programs in genetic dilated cardiomyopathy and ADPKD. We also hold significant stakes in BridgeBio Oncology Therapeutics and Gondola Bio. In the latter, Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:10:29we expect Phase two data in Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:10:30our EPP program later this year, and we expect to generate up to six development candidates in 2025. From an ecosystem framing, the substrate for making genetic medicines remains incredible. We see that in the progress Gondola is making and more broadly with the depth of genetic disease starting points being produced and accessible at low price points. Finally, at a program level, Matt will have more to say about our commercial launch of Atruby. Our goal there, as a reminder, is 4,300,000,000 in peak year sales or about 30% of a $15,000,000,000 marketplace. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:11:07That gets delivered against approximately $380,000,000 of spend on the brand per year. Almost 25% of current spend is on further research and development activities like Act Early, which we think could continue to improve our medicines positioning and its ability to help patients in later years. The product of this spend also includes salient results like our variant data, where we obtained a hazard ratio of 0.41 with a p value of less than 0.02 in the sickest of patients, and new work we are doing regarding AFib, which is an emerging marker of disease progression, the first results of which we plan to present at ESC later this year. For Impregratinib, a first in class oral FGFR3 inhibitor in development for both achondroplasia and hypochondroplasia, the pivotal PROPEL3 Phase three is fully enrolled and we expect last participant last visit by the end of this year. We have also reached regulatory alignment with the FDA on our clinical development plan for Imfibratinib in children with achondroplasia from ages zero to three and we expect to initiate clinical development in this important age range by the end of the year. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:12:21Excitingly, we have also enrolled the run-in for our Phase two hypochondroplasia trial well ahead of benchmarks. For INCALARIT, a negative allosteric modulator of the calcium sensing receptor, our Phase three CALIBRATE study is fully enrolled. We expect last patient, last visit and top line results in the second half of this year. In parallel, CALIBRATE is also being studied in hyperparathyroidism and we announced today positive POC data for CALIBRATE in this key expansion indication. Preliminary evidence in the ongoing POC study has demonstrated that seventy eight percent of the first nine study participants were able to achieve normal blood and urine calcium levels within five days of ANCALARA administration. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:13:07Moving to BVP-four eighteen, an oral first in class disease modifying therapy in Phase III development for treatment of individuals living with Limb girdle muscular dystrophy type 2I. We have fully enrolled FORTIFY, a Phase three registrational placebo controlled study evaluating the safety and efficacy of BBP-four eighteen. The study includes a planned interim analysis to twelve months focused on assessing a surrogate endpoint biomarker glycosylated alpha dystroglycan to support accelerated approval in The United States. We anticipate top line readout from that Phase three interim analysis second half of this year as well. Finally, BVP-eight twelve is an AAV9 gene therapy in development for Canavan disease, an ultra rare neurodegenerative disease that usually leads to death in the first two decades of life. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:14:00Here, we are pursuing an accelerated approval approach using a single seamless registrational trial to bring this potential therapy to children with Canavan as quickly as possible. A meeting this month with the FDA reinforced the validity of our approach which centers around the use of urine NAA in tandem with other clinical measures and the suggested BLA filing that we have laid out by end of twenty twenty six. While this is not a very prevalent disease, we believe it's a great example of our model, targeting disease at its source and operating leanly to enable us to go after a well validated condition in an NPV positive manner. Okay, that's the final framing. To wrap up my comments, BridgeBio is executing well and importantly possessed a tremendously strong foundation for the future. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:14:47Number one, an unmatched collection of late stage genetic disease businesses with favorable economic prospects. Number two, a cadre of outstanding managers that are dedicated to their specific assets business and to BridgeBio number three, a diversity of stakes, including wholly owned assets and significant stakes in Gondola Bio and BridgeBio Oncology Therapeutics number four, first choice ranking with many academics when seeking a partner to discover and develop new medicines. And number five, a culture that is distinctive from most biotechs I have seen and that is decentralized independent thinking and lives the value that every minute counts for the patients we serve. We're excited to work with you, our investors to continue to build this company and to keep you up to date on our progress for patients. With that, I'll hand it over to Matt to walk through Atruby's commercial performance in more detail. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:15:42Thanks, Neil. To add to your comments, the launch of Etruevi is off to a strong and encouraging start. Let me walk through some of the highlights in terms of what we are seeing out in the marketplace and what we think is driving the rapid momentum we've built in just a few short months. The first highlight is the early uptake across all major prescriber and patient segments. As shared in our press release, two thousand and seventy two unique patients have received a prescription for Etrube through April 25, and seven fifty six unique health care providers have written at least one prescription. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:16:17This early adoption spans all physician segments, including large academic centers, regional amyloid clinics, high volume heart failure specialists, and community cardiologists. Importantly, we're seeing attributed use across the full spectrum of patients, wild type invariant, newly diagnosed, as well as switches from partial stabilizers. The fact that these different patient types are all gaining timely access and that prescribers are already writing for multiple patients gives us confidence that we're building a strong foundation for Atruvio. So let's discuss what is driving the uptake. It comes down to strong clinical endpoints paired with our transparent patient first support programs. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:17:00Starting with the clinical data, Atruvio is the only therapy for ATTR Centimeters that has demonstrated a separation from placebo in as early as three months. No other medicine has demonstrated that, and it's not just about efficacy. ATRUVY also positively impacts KCCQ scores, which directly correlate with better quality of life for patients. That's resonating deeply with physicians who want to make a meaningful impact on their patients' daily lives and patients who want to keep their functional activity levels. Second, let's look at hospitalization rates. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:17:35Atruvio is the only ATTR Centimeters therapy to demonstrate fifty percent relative risk reduction in cardiovascular hospitalization rates. This includes a statistically significant reduction in composite of mortality and hospitalization in the variant ATTR Centimeters population, a subgroup widely regarded as among the most difficult to treat. This was highlighted in the recent variant subgroup data presented at ACC. And third, affordability. Atruti is the most cost effective therapy in ATTR Centimeters available, 10% less expensive than Tafamidis and 50% less expensive than Vutrisiran. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:18:16It's not just about the WAC price, though. Atruevi has a free trial program for all patients regardless of insurance status and lifetime free drug for patients who participated in our pivotal trials. That matters to physicians, patients and payers, especially when coupled with the three month onset of treatment effect and fifty percent reduction in cardiovascular hospitalization at thirty months. No other ATTR Centimeters therapy checks all of these boxes. BridgeBio has a commercial model that is different, and it's working. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:18:50ATTRIVUE will be followed by three additional commercial launches in 2026 and 'twenty seven. What really differentiates BridgeBio, though, is how we bring products to market. There are no convoluted value based contracts, no vague promises of future rebates contingent on volume thresholds. What we offer is simple, transparent, and built around the people who matter most, patients and their care teams. And we're hearing from the field that this clarity, paired with strong clinical data, is helping accelerate adoption. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:19:22And once an HCP decides to prescribe Atruvi, we make it easy to get the medication to patients. Patients can receive Atruvi within forty eight hours. We have two world class specialty pharmacies in the Atruvi network and also allow physicians to fill prescriptions in their own in house pharmacies. All of this investment is paid off. We are gaining share in the crucial first line setting and our conversion to paid rate and time to paid prescription is well ahead of industry benchmarks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:19:52Looking towards the future, our focus heading into the rest of the year is as follows: continue marching towards our long term goal of 30% to 40% share of the ATTR Centimeters market and increase share in the critical first line setting, which is a leading indicator of launch success. While these early signs are encouraging and they reflect not just the strength of the product, but the preparation and the commitment of the broader BridgeBio team, we are also excited about what's ahead and remain focused on reaching as many patients as possible as quickly as possible. With that, I'll turn it over to Tom for a review of the financials. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:20:31Thank you, Matt, and good afternoon, everyone. Q1 twenty twenty five marked BridgeBio's first full quarter of net product revenue from the Attribute U. S. Commercial launch, major milestone for the company and a significant step forward in our evolution into a fully integrated genetic medicine business. I'll now walk through the financial highlights for the first quarter of twenty twenty five. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:20:50Please note that our commentary on today's call will focus on GAAP financial measures unless otherwise indicated. Total revenues were $116,600,000 for Q1 twenty twenty five and consist of attributed net product revenue and license and services revenue. Attributing net product revenue was $36,700,000 driven by strong demand across all major prescribers and patient segments. License and services revenue was $79,900,000 in the quarter, primarily driven by the recognition of the $75,000,000 regulatory milestone related to BEYONDRA's EU approval. Also in Q1, we received BEYONDRA approval in Japan for which we expect to recognize a $30,000,000 milestone in the second quarter. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:21:32Total operating expenses for the first quarter of twenty twenty five were $218,400,000 compared to $210,200,000 in the same period last year. This increase reflects our continued investment in the Atruity brand and our advancing late stage pipeline. Included in our total operating expenses was $29,400,000 of stock based compensation expense compared to $28,900,000 in the first quarter of twenty twenty four. Looking forward, we expect only modest growth in quarterly operating expenses for the remainder of the year with an offset to total cash burn provided by Atruvio sales in The U. S. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:22:04And BEYONDRA ex U. S. R and D expense for the first quarter of twenty twenty five was $111,400,000 compared to $141,000,000 in the same period last year. This decrease was largely due to the strategic carve out of our oncology business and early stage research programs, allowing us to focus resources on the Atruvian launch and late stage pipeline. SG and A expense for the first quarter of twenty twenty five was $106,400,000 compared to $65,800,000 in the same period last year. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:22:33This increase was driven by the full scale commercial rollout of Atruby, including field team deployment, payer engagement and patient support infrastructure. Restructuring expense for the first quarter of twenty twenty five was $600,000 compared to $3,400,000 in the same period last year. We ended the quarter with 5 and $40,600,000 in cash and cash equivalents, which does not include $105,000,000 in regulatory milestone payments anticipated in Q2 for ex U. Approvals of BEYONDRA. We believe we are well financed towards the continued execution of Atruvio launch and deliver on key milestones from the pipeline this year. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:23:10We look forward to sharing additional commercial updates throughout the year with the top line data from our three Phase III programs over the next year with ADH1 and LGMD2I in the second half of twenty twenty five and achondroplasia in early twenty twenty six. With that, I'll turn the call back to Chimai. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:23:26Thank you, Neil, Matt and Tom. I'll now hand it back to the moderator to open the line for questions. I would like to request our analysts to limit themselves to one question each so that more people get a chance to ask their questions. Operator00:24:06Your first question comes from the line of Salim Syed of Mizuho. Please go ahead. Salim SyedManaging Director, Equity Research at Mizuho Securities00:24:12Great. Congrats on the quarter guys and congrats also on your first earnings call. Maybe just one for Neil or Matt here. Obviously, the quarter came in healthier than I think people had thought going into the print. And I appreciate the commentary that you provided, Matt, on some of the dynamics there. Salim SyedManaging Director, Equity Research at Mizuho Securities00:24:33But any sort of granularity you could provide on the tailwind and what you really deem that's working well for you here? Thank you. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:24:40Yes. Maybe I'll kick it off. Thanks, Salim. It's probably too early for some of the higher cost commercial tactics that we've invested in to show ROI right now. So hearteningly, I think a lot of the demand we're seeing to date really is a product number one of the differentiated clinical efficacy. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:24:58We have as a reminder and you know this, the earliest separation and point estimate that we've seen in the field at three months, forty two percent relative risk reduction against ACM and CVH at thirty months. Again, the best point estimate we've seen at thirty months coupled with that fifty percent reduction in hospitalization, which turns out to be a hugely meaningful measure for patients who both want to live longer, but also live healthier. So I'd say that's point number one. Point number two, as you saw as well from the Pfizer call this morning, continued market growth, right? We're one fifth diagnosed in this space, some 50,000 or so patients diagnosed. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:25:34We think there's 250,000 to 300,000 in The U. S. Alone. And so physician education coupled with there being a variety of therapeutic interventions now available, I think is driving that growth. That I think is another tailwind. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:25:48And then the third is the access programs that Matt talked about. The team, think, done a terrific job of ensuring that patients, when they are prescribed Vitruvi, can get the medicine and stay on the medicine as long as they need to. So those would be the three salient drivers. I'd say the final thing is a little bit of what a physician described to us the other day as Karma. Obviously, we're the only sponsor in this space that gave free drug for life for their trial participants. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:26:15Unfortunately, others decided not to. We're also the only sponsor in this space running a primary prevention study, which I think many physicians view as the ultimate in trying to catch patients in this mass action condition as early as possible to do as much as we can for their condition. So those types of things, I think, over a long period of time will stand us in good stead as sponsor here in competitive space. I don't know, Matt, if you'd add anything. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:26:40No. I think to miss the people. We've spent a lot of time putting the team together, both internally in the field, to make it as easy as we can for both prescribers and for patients, and I think you're seeing the good results of that. Salim SyedManaging Director, Equity Research at Mizuho Securities00:26:55Great. Thanks, guys. Congrats again. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:26:58Thanks, Wayne. Operator00:27:00Your next question comes from the line of Tyler Van Buren of TD Cowen. Please go ahead. Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:27:07Hey guys. My congrats on the stellar Atruvu result as well and the ongoing progress of the pipeline. So again the $37,000,000 of Atruvu sales far exceeded expectations. So when you say that the paid conversion rate is well ahead, can you help quantify that? Was the time to pay quicker than a month for some patients? Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:27:26And how much stocking was there in the quarter? Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:27:30Hey, Tyler. Great to hear from you, and thanks for the question. I'm going to pass it on to Matt to comment more on conversion. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:27:37Yeah. Thanks for the question. You know, we're really happy with how conversion is tracking, and that's for both free trial to paid and also commercial prescriptions to paid. Everything regarding conversion is consistent or better than historical launches that we've studied. I will just point out a free trial acts like a normal prescription. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:27:58A HCP writes it, the pharmacy processes it, and the patient gets it. And we designed our network specifically with conversion in mind, and that's what makes the access so easy. Our goal remains the same, 30 to 40% peak share. It takes about three to six years usually to hit. We're hoping we can do that a little bit faster. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:28:21In regards to your channel and inventory question, I mentioned we do have a limited distribution network that allows for very frequent ordering, and it allows our customers, our distributors to have just in time inventory. So there's no need for them to really hold large quantities. And so typically, I would say that this small group of distributors holds about one to two weeks of inventory. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:28:45Hey, Tyler. This is Tom. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:28:46Let me just put a finer point on the inventory question. As I mentioned in Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:28:49the prepared remarks, the sales in the Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:28:51quarter were primarily driven by demand. So we've seen only a minor impact of inventory on total sales in the quarter. So real really demand driven here. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:28:59Yes. Thanks, Tyler. I know you had another question. Happy to answer more about this or go to your next question. Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:29:08No. That's great. Thank you. Operator00:29:13Your next question comes from the line of Manu Foroohar of Leerink Partners. Mani ForooharSenior Managing Director at Leerink Partners00:29:17Congrats Mani ForooharSenior Managing Director at Leerink Partners00:29:21on the quarter. Clearly, it blew out expectations despite having shown pretty good scripts repeatedly. I wanna dive in on the script numbers. I'm looking at the incremental scripts on a weekly basis through that first update on January 10, was in the sixties per week, and then through the update you gave on on incremental basis on February 17, that was running north of a hundred scripts a week and, again, running through from twelve and four four weeks into launch and twenty two weeks into launch, I e, from February 17 to April 25, you're still running at about a 10, hundred nine scripts per week as reported. I know it's just math, and there's a lot of nuance that goes into script reporting. Mani ForooharSenior Managing Director at Leerink Partners00:30:03Could you give us a sense of what the the character and velocity of new of new patient scripts you're seeing right now, and so what is the but what is the kind of direction of travel that's there? And I have a follow-up question. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:30:19Great. I can take that. Thank you for the question. I mean, I think starting out, the thesis really, again, it remains unchanged. TTR levels go up with the Truvy, and it's the only near complete stabilizer on the market. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:30:32When we sort of take that thesis and then dive into, okay. Well, what's happening, and then how do we think that's gonna impact things going forward? The month over month growth rate in the treatment naive section has been very strong, and that's been across all segments. So this is in the large centers. This is in the community. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:30:50It's across all types of patients, variant, wild type. There hasn't been a sort of one area or another that's done better. We've sort of seen this across the board. And so then when we look at sort of Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:31:04the two groups, we have Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:31:05the treatment naive patients. That's our focus, and that will continue, we believe, to grow over time as it has been. Then you have the switch patients. Of course, when we launched, we had a % of the switch share because we were the only option you could switch to. As new now with new entrants in the market, that's going to evolve over time because there are now more choices. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:31:28And so I think that the data and how we report will evolve over time as well based on that, but that's kind of where we are and how we see it moving forward. Mani ForooharSenior Managing Director at Leerink Partners00:31:40Great. That's helpful. And I have sort of a non TTR question to everyone's surprise. When you think about limb girdle data coming later on this year, which obviously have we've we've been discussing a number of calls. This is not the first time you guys have brought it up. Mani ForooharSenior Managing Director at Leerink Partners00:31:58We talked about it at my conference a couple years running, about the filability of that dataset or whether a later dataset from the same study will be required. Do any of the changes of FDA concern you around your ability to file on a biomarker? Do you think you have to show a distinct level of clear clinical improvement on a on a non biomarker slash functional basis? Like, where where are we in terms of the filability on that biomarker for limb girdle? Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:32:29Yeah. I can I can take that, Mani? You know, we haven't met with the agency of late on the LGMD2I program, but we have had some close to 10 meetings now over the course of the last month as it pertains to either pipeline at Gondola or pipeline here at Bridge, probably the latest meeting was in and around the Canavan program. And I have seen nothing but I would say a positive inclination toward trying to get first in class medicines that target path of mechanism like our drug for LGMD2I onto the marketplace as quickly as possible to benefit the children that are suffering from these conditions. And so I don't think the rather clear guidance that we've gotten from the agency to date in and around fallibility around glycosylation of ADG is going to change. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:33:23I really don't. I have been on the record saying, I think it's going to be a problem if we go the right way and hit our primary endpoint on ADG, but we go the wrong way on all clinical measures. Obviously, don't think that's going to be the case based on what we observed in Phase two, which was albeit an open label study against natural history where we saw improvements in measures of ambulation and other clinical outcomes. So I do believe these things will move toward the positive or at least a few will move toward the positive. Obviously, modified North Star, North Star, which is historically been the gold standard in these conditions, it's all noise over the course of the first twelve months. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:34:03So whether the point estimate goes one way or the other, I think natural history has made that very clear. And that is why we're running the confirmatory trial. This is effectively a nested trial design that goes on for another two point five years post the readout later this year. So I mean, long story short, yeah, we continue to believe that this is going to be an approval endpoint in terms of ADG glycosylation increase. Mani ForooharSenior Managing Director at Leerink Partners00:34:31Awesome. Thanks, guys. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:34:34Thanks, Mike. Operator00:34:35Your Operator00:34:39next question comes from the line of Tyler Van Buren of TD Cowen. Please go ahead. Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:34:48Hey guys. Yes, just had a second question that I meant to ask. But just the ADH-one and Limb girdle Phase III is reading out during the second half of the year, clearly have a high probability of success. So can you it would be great to hear you elaborate on why investors should be excited about and more importantly focus on those opportunities beyond the ongoing Atruvio launch. What do Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:35:05you think the magnitude of those opportunities could be? Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:35:10Yes. Good question, Tyler. As I was suggesting, continue to be heartened by both the clinical operational positioning of LGMD2I, ADH1 and our achondroplasia trials as well as the potential to help a broad swath of patients. And I think from an investor standpoint, one has to consider the sheer size of these marketplaces, LGMD2I, as we've discussed, some seven thousand to eight thousand patients between The U. S. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:35:36And EU. That's a substantial market size as compared to many of the other muscular dystrophy programs that you see out there at the price points that are attended in the space. And with ADH1, a rather much more prevalent condition maybe ten thousand to twelve thousand patients in The United States alone, as suggested by statistical genetics methodology, some four thousand or so already identified to date. That's going to be really a program associated with the market build and finding new patients. And we've already shown that we can do that in some of the sequencing efforts we've undertaken within the non surgical hypoparic community where we're reliably finding something twenty percent to twenty five percent of patients actually harbor the gain of function mutations in the calcium sensing receptor. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:36:24So I think two very exciting commercial opportunities, two very exciting opportunities for first in class medicines for patients there. And then I don't think I need to belabor the achondroplasia hypothesis where we feel we have an exciting oral best in class potentially best in class option that could provide differential safety, differential efficacy because it targets this well described condition at its source driving differential both changes in growth and then also importantly impact on parameters that this community cares a great deal about like proportionality and the like. And you know the size of that market from the Box of the launch that's ongoing. I think all three very exciting opportunities. Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:37:10Thank you. Operator00:37:15Your next question comes from the line of Biren Amin of Equity Research Healthcare. Please go ahead. Biren AminManaging Director & Senior Research Analyst at Piper Sandler Companies00:37:22Yes. Hi. Thanks for taking my questions. Congrats on the quarter and really good launch out of the gate. I guess my question is what's resonating with health care professionals as it relates to the Truvy launch? Biren AminManaging Director & Senior Research Analyst at Piper Sandler Companies00:37:34And what are the biggest hurdles that you're seeing for adoption? And then maybe a second question. What was the gross to net for the quarter? And any impact that you've seen from the Part D redesign? Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:37:45Hey, Viren. Thanks for the question. I'm going to pass it on to Matt to discuss the HCP piece and then also to Tom to discuss the gross to net piece. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:37:56Yeah. Thanks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:37:57And I guess there's sort Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:37:58of two parts to this. You know, the feedback from the physician segments has been positive as we've discussed. Our messaging around, you know, we call it the three forty two fifty, but that ability to separate as early as three months and getting results around the hospitalization, all cause mortality, that we've described. Physicians wanna see a drug work really fast, and they wanna be able to tie it to hard hard outcomes. Of course, patients do too, but this is what gives people confidence. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:38:31And so those messages have been resonating extremely well, and I think that's resulted in physicians trying Atruvite, but then also then repeating it. Right? Those are the reasons that you sort of try a medication, and then you when you see how well people are doing on it, then that encourages you to try it again. So we've seen a lot of repeat prescribers across a lot of the different segments as well. And I don't think our expectations were otherwise or are are going to change anytime soon. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:39:01We have very strong data package, and we also have very strong programs to help patients get on the medication once that prescription has been written. And then I'll pass it to Neil to add on that. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:39:11Yeah. Maybe I'll just elaborate on that for a second before I throw it over to Tom. You know, I think the the, ever increasing, availability of data, like most recently, Varun, I think we've talked about the variant data. The fact that you could achieve a hazard ratio of 0.41 with statistical significance in that relatively small sub population and as someone mentioned earlier, the sickest of sub populations continues to reinforce that differential levels of stabilization can lead to ever better outcomes. And we're starting to find that that's resonating. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:39:44We've got a bevy of serum TTR associated literature coming out suggesting that ever higher levels of serum TTR correlate with ever lower levels of downstream hospitalization and mortality. The connecting of the dots between ever better stabilization and all of these downstream outcomes, think is what's starting to resonate with the physician community on top of what Matt suggested the backbone, which is the three forty two fifty. Tom, you want talk about GTN? Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:40:12Yes. Sure. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:40:12On gross to net specifically, so as we've said before, the way to think about this is the floor is going be the mandatory IRA rebate of 20%. And on top of that, you're gonna add something something like you'd see in other con categories where contracting is not really happening. So that's what we're seeing here. I would say, given where we are in the launch early innings, we should expect some variability here quarter to quarter. This quarter, gross to net trended slightly favorable versus what we were expecting. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:40:41We also saw a slightly lower use of our first month free program versus what we were expecting, and we saw a slightly lower use of our patient assistance program than what we're expecting. These three things together actually converged and caused slightly better net revenue per per unit than than what we were expecting, but we expect all of this to normalize over the course of the year. Biren AminManaging Director & Senior Research Analyst at Piper Sandler Companies00:41:03Great. Thank just Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:41:04to add that, you know, the results are reflective of strong strong underlying demand for a true b and and the execution of our commercial team. As Matt mentioned, not a lot of inventory or anything like that. Biren AminManaging Director & Senior Research Analyst at Piper Sandler Companies00:41:18Thanks. Perfect. Operator00:41:22Next question comes from the line of Cory Kasimov of Evercore. Please go ahead. Cory KasimovSenior Managing Director at Evercore00:41:29Good afternoon guys. Thanks for taking the question. So it's great to see that Ruby is off to such an impressive start, you kind of alluded to this in a prior response. But now that you're on the market for over a quarter, how are you thinking about new patient starts for the category going forward? I know previously, you've talked about numbers like 2,000 to 3,000 restarts per quarter, but that's already looking pretty conservative. Cory KasimovSenior Managing Director at Evercore00:41:50So any, kind of new color there would be appreciated. Thank you. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:41:55Yeah. Hey, Corey. Thanks for the question. I I think you're kind of thinking about it like we're thinking about it. It it does seem to keep going up every quarter. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:42:03And if you look historically, you know, that's no different. I think it is ramping a bit faster, but that also makes sense because you're getting new products in the market. So the more companies that launch a product into a space, that creates a higher share of voice, and I think that gets people educated either to go get screened or for physicians to think to themselves I mean, if you're a cardiologist and you have PSPF patients and you're not thinking to yourself, hey, some of these must be ATTR Centimeters patients, all of these companies are discussing it, educating, talking about it. It gets people looking, and if you look, you find it. It's it's not that uncommon. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:42:43You know, most cardiologists have some patients that need to be treated. So I think that, you know, we don't see that stopping anytime soon. The market could easily be a $20,000,000,000 market, and we're not there yet. So there's still a lot of patients who are out there who have not been diagnosed, but I think you're going to see continued high numbers of people being diagnosed now that that interest is just continuing to grow. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:43:08Yeah. And, Corey, just to add one last thing. You know, a lot of the new diagnosis is coming from the high volume heart failure clinics that Matt mentioned in his remarks, and, obviously, an oral small molecule stabilizer is is a great fit for those patients. Cory KasimovSenior Managing Director at Evercore00:43:23Absolutely. Very helpful. Thank you. Operator00:43:29Your next question comes from the line of Greg Harrison of Scotiabank. Please go ahead. Greg HarrisonDirector - Biotechnology at Scotiabank00:43:35Hey, good afternoon, guys. Congrats on the huge start to the launch, and thanks for taking our questions. So in our initial modeling conversations, with you guys, our takeaway was that your expectation was for initial uptake to come, you know, primarily or almost exclusively from newly diagnosed patients. But to get to the revenue number you've reported, you have to get most of them by our math. So assuming that's not the case, you know, is this a a function of, much larger market growth than you expected, or, are you getting a large percentage or or maybe even most of your patients as tafamidis switches? Greg HarrisonDirector - Biotechnology at Scotiabank00:44:18And if that's the case, how do you expect, this trend to evolve from here? Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:44:23Hey, Greg. Thank you so much for the question. So I think as we have said consistently, our focus at launch has been the treatment naive market. Very early on, we got a few more switch patients than we expected, but, you know, that started to normalize. Focus continues to be new treatment naive patients, and I think Matt mentioned in his remarks that there we are seeing consistent monthly growth, you know, gradually. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:44:50In terms of what's driving the the number, I think it's it's sort of all of the above. Right? I think it's a little bit of the market growth, you know, obviously, strong demand and and strong conversion. Maybe I'll throw it on to Matt, and and he can talk a little bit more about the factors, you know, driving conversion and and the market size. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:45:09Yeah. No. I think you I think you hit it well, Chinmay. I don't know that I would add that much. You know, it's a little tricky when you try to figure out who a switch patient is. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:45:19You know, they can they look like a new patient, most of the time. So I think it's a little you have to be a little careful trying to determine who's a switch and who's new. Our focus is on the newly diagnosed. We do see switch patients come in, and sometimes we can tell that they're a switch patient. Other times, it's not clear. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:45:38But I think as you think about the rest of '25 moving into '26, I think the market continues to grow. It's been growing double digits now for quite a long time, and this past quarter, one of the best we've seen. I would not expect that to disappear anytime soon. There will be switch patients who want a Truvy, and there will be a lot of newly diagnosed patients that want a Truvy for all the reasons we've discussed, whether it's the the data itself, the programs we offer. You know, I I I think we're very optimistic about all of that. Operator00:46:11Your Operator00:46:16next question comes from the line of Paul Choi with Goldman Sachs. Paul ChoiAnalyst at Goldman Sachs00:46:25And congratulations on knocking it out of the park in your first quarter here on the launch. I want to just shift gears for a minute, maybe just ask a policy question, which is to think about as a true regrowth in scale over the coming years here or this year and next year, as well as you start to get sales from Europe from Bayer and on BIANTRA and AstraZeneca in Japan. Could you maybe just help us think through where your IP is domiciled and just sort of the tariff implications and just sort of the royalty streams that you'll be getting from your ex U. S. Partners and just sort of how that ultimately affects your margin and your sort of profitability profile? Paul ChoiAnalyst at Goldman Sachs00:47:06Any color there or directional guidance would be helpful. Thanks. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:47:11Hey, Paul. Thanks for the question. This is Tom. Yes. So as Neil indicated in his prepared remarks, we're fortunate to have very little impact from any of the tariff discussions that are ongoing. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:47:22We've done a pretty deep dive on this. As you know, the pharmaceutical has been exempt from the reciprocal tariffs, but we've also looked at the IEP or IEPA and what's been said in public around the potential two thirty two tariffs affecting the industry. When we put all that together based on our supply chain, we see very, very minor impact. That's because Etruvia is made here in The USA. And then we're, of course, an American company, and we have all our IP domiciled here in The US. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:47:48So overall, very minor impact to the business. I'm not sure I understood the question on the royalties and how that relates, but that's off the top line revenue number. So obviously, we're getting money coming to us as before any any implication on tariffs that would be on Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:48:06their end, but maybe I didn't understand the question. Paul ChoiAnalyst at Goldman Sachs00:48:09No. That that that that makes sense on the ex US business. Operator00:48:19Your next question comes from the line of Anupam Rama of JPMorgan. Anupam RamaAnalyst at JP Morgan00:48:23Congrats Anupam RamaAnalyst at JP Morgan00:48:29on the quarter with Atruby. I wanted to just pop in with a very quick pipeline question. So you shared some data today on the chronic hypoparathyroidism, indication. So what gets you excited about this opportunity, particularly from you talked about Neil from an NPV perspective? How does that all fit in? Anupam RamaAnalyst at JP Morgan00:48:45Thanks so much. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:48:47Hey, Anupam. Thanks for the question. We're gonna drive it to Neil to talk about the NPV, then Anand can talk more about the data and our exciting plans for the phase three in HP. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:48:57Yeah. I mean, from an NPV standpoint, Noop, I think you know that this is an exciting extension population, quite a bit larger than ADH1 itself with actually a pretty reasonable price point as well given where Ascendis ended up pricing their medicines. So there's a variety of different ways for us to take advantage of the opportunity now that many of the oral competitors have fallen by the wayside. I'm going to actually pass it over to Anant to talk a little bit about the exciting data that we just posted. Ananth SridharCOO - Cardiorenal at BridgeBio Pharma00:49:26Hey, Anantam. Great question. Ananth SridharCOO - Cardiorenal at BridgeBio Pharma00:49:28Thanks for your interest in this program. We so as you mentioned, we we reported data from the first nine participants with postsurgical hypoparathyroidism that were treated with Incalarat. It normalized blood and urine calcium concomitantly in seventy eight of these participants and serves to be the, important oral option for these patients seeking to resolve calcium homeostasis. So we think that this could be a treatment changing or a paradigm changing treatment, and we will advance development towards registration for this program. And in terms of the NPV or the market opportunity, Neil mentioned, this is about a seven to eight times larger marketplace than the ADHD market alone, so it could grow and expand the the presence of Incalorate as as we continue to investigate molecule. Anupam RamaAnalyst at JP Morgan00:50:22Thanks so much, guys. Operator00:50:28Your next question comes from the line of Ellie Merle of UBS. Please go ahead. Eliana MerleAnalyst at UBS Group00:50:33Hey, guys. Thanks for taking the question and congrats on the quarter. What you're seeing so far in terms of commercial trends since Ambutra's approval. You have a few weeks of experience now with this so far. So, I mean, I guess, specifically, was the rate of unique patient prescriptions consistent with what you saw in February and March? Eliana MerleAnalyst at UBS Group00:50:53Did you see an increase by an April associate of the broader prescriber base? Or have you maybe seen a dip in the rate of new unique patient starts just with the launch of a competitor? And any sort of high level commentary on how you're thinking about positioning? Are there certain segments where you see potential greater uptake or advantages in terms of your use? Thanks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:51:18Sure. This is Matt. Thank you. For the second half of your question, the audio was a little garbled. So let me answer the first one, and then if you want to repeat the second one, I'm happy to address that as well. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:51:30Your your first one regarding Ambutra, you know, I there's definitely a place for lots of choices in this market, and I think as a company, we're obviously happy when patients have additional choices. In terms of where Ambutra is going to be placed, you know, they seem to be earmarked for mixed phenotype at the moment. That's probably ten percent of the overall market. You know, their variant data wasn't stat sig, and they're very expensive. So it's twice as expensive as a Truevi right now. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:52:05And they have to compete, obviously, with our three forty two fifty, which has been pretty successful. So I don't I don't know where that's going to land for them. I I think they have to figure out their pricing. You know, if you're gonna charge double, you you need to have better results. And, you know, I think you can ask them to to talk about that. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:52:26I'm sure they they'll have opinions on that. But right now, it's early, but we're not seeing a lot of uptake outside of the mixed phenotype. Eliana MerleAnalyst at UBS Group00:52:36Got it. And then just maybe this was the part of the question that broke off. Let me know if you can't hear me. But just in terms of the rate of unique patient prescriptions, I guess, you seen any change in that, since the approval of Ambutra? So, you know, for instance, if you saw a dip in the rate of new unique, patient prescriptions in April, or let's say now that you have a broader prescriber base, you've seen a similar rate in new patient prescriptions or even higher. Eliana MerleAnalyst at UBS Group00:53:07Thanks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:53:09Yeah. So the April data, I probably wouldn't be able to comment on. I mean, you know, they were sort of out two weeks in q one, and now, you know, we we've picked up some data. We see some of the same stuff that you guys see. The trouble is, you know, even you know, it's buy and bill, and so, you know, they're they're trying to convince a community physician to put out over a hundred thousand dollars per injection. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:53:35You know, the vitamin a part's cheap. So, you know, from a cost perspective, that's fine. You still have to take that every day. But the that out of pocket for the doctor, they have to cash flow that. So they have to put that money out, and then they have to wait to get reimbursed. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:53:49Well, if you start stacking up a lot of patients, that's a lot of money, and, it gets pretty expensive. So we haven't seen it yet. It doesn't necessarily mean it is or isn't happening. You know, I I think you'd have to ask them. Maybe they can do what we did and throw out some early numbers on what the first month of launch looks like. Eliana MerleAnalyst at UBS Group00:54:12Got it. Thanks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:54:16No. Thank you. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:54:17Appreciate your question. Operator00:54:18Comes from the line of Jason Zemanski of Bank of America. Please go ahead. Jason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:54:23Great. Good afternoon. Congratulations on the quarter and thanks for taking our questions. I wanted to return to the question of segment growth for Atruby, if I may. It sounds like you expect the contribution from switches to slow at some point. Jason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:54:38But what does that look like over the near term? I mean, do you have a sense of how quickly you may be going through a bolus of, I don't know, refractory patients versus those as you mentioned, you know, are looking for a stronger stabilizer because they believe in the the better outcomes over time? Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:54:55Hey, Jason. Thanks for the question. I think that high level, I can I can say a couple of things and then Matt Matt's gonna add more details? But as we have said all along, you know, we're not seeing any bolus or anything like that. I do think that the focus of our launch is treatment naive, and there we're seeing consistent monthly share growth, and we expect that to continue. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:55:18We had a % share in the switch population, and and, obviously, that's going to evolve now that there's a competitor. So that's sort of how we are thinking about it. Obviously, it's very early to say, and and we look forward to seeing how the next quarter goes. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:55:33Yeah. And I'll just add. I mean, I agree. We didn't see a bolus. I mentioned earlier, it's a little tricky to absolutely know if someone is a switch or a newly diagnosed. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:55:44We we don't spend a lot of time sort of thinking about it from that perspective. If patients wanna get a Truvy, we try to make sure they can get it for, you know, whoever they are, newly diagnosed or switched. In terms of what that looks like over time, I I think that's hard to predict. You can take the number of patients on to Famidis. You can add on a progression rate of whatever you think is correct and then kind of model that out over time. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:56:11I think that's probably the best approach of any. Operator00:56:16There are no further questions at this time, and that concludes our q and a for today. I will now hand this call back over to the company. Please go ahead. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:56:25Thanks everyone for your questions today. We appreciate your interest in BridgeBio and look forward to updating you again next quarter.Read moreParticipantsExecutivesChinmay ShuklaVP - Strategic FinanceNeil KumarCo-Founder, CEO & DirectorMatthew OuttenChief Commercial OfficerThomas TrimarchiPresident & CFOAnanth SridharCOO - CardiorenalAnalystsSalim SyedManaging Director, Equity Research at Mizuho SecuritiesTyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD CowenMani ForooharSenior Managing Director at Leerink PartnersBiren AminManaging Director & Senior Research Analyst at Piper Sandler CompaniesCory KasimovSenior Managing Director at EvercoreGreg HarrisonDirector - Biotechnology at ScotiabankPaul ChoiAnalyst at Goldman SachsAnupam RamaAnalyst at JP MorganEliana MerleAnalyst at UBS GroupJason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill LynchPowered by Conference Call Audio Live Call not available Earnings Conference CallBridgeBio Pharma Q1 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipants Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) BridgeBio Pharma Earnings HeadlinesCantor Fitzgerald Issues Positive Estimate for BBIO EarningsMay 4 at 2:11 AM | americanbankingnews.comBridgeBio Pharma (NASDAQ:BBIO) Price Target Raised to $72.00May 3 at 2:45 AM | americanbankingnews.com5 Stocks Poised to Soar Under Trump's PresidencyWith the next presidential cycle heating up and Trump leading the charge, major market shifts are already taking shape. For investors who position early, the opportunities could be significant. That’s why we’ve just released a brand-new report: 📈 “5 Best Stocks to Buy Under Trump’s Presidency.”May 5, 2025 | Darwin (Ad)Piper Sandler Issues Positive Forecast for BridgeBio Pharma (NASDAQ:BBIO) Stock PriceMay 3 at 2:45 AM | americanbankingnews.comScotiabank Raises BridgeBio Pharma (NASDAQ:BBIO) Price Target to $55.00May 2 at 2:49 AM | americanbankingnews.comBridgeBio Pharma (NASDAQ:BBIO) Reaches New 1-Year High After Better-Than-Expected EarningsMay 2 at 1:09 AM | americanbankingnews.comSee More BridgeBio Pharma Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like BridgeBio Pharma? Sign up for Earnings360's daily newsletter to receive timely earnings updates on BridgeBio Pharma and other key companies, straight to your email. Email Address About BridgeBio PharmaBridgeBio Pharma (NASDAQ:BBIO), a commercial-stage biopharmaceutical company, discovers, creates, tests, and delivers transformative medicines to treat patients who suffer from genetic diseases and cancers. Its products in development programs include AG10, a next-generation oral small molecule near-complete TTR stabilizer that is in Phase 3 clinical trial for the treatment of TTR amyloidosis, or transthyretin amyloid cardiomyopathy (ATTR-CM); low-dose infigratinib, an oral FGFR1-3 selective tyrosine kinase inhibitor, which is in Phase 3 double-blinded, placebo-controlled pivotal study for the treatment option for children with achondroplasia; and BBP-631, an AAV5 gene transfer product candidate that is in Phase 1/2 clinical trial for the treatment of congenital adrenal hyperplasia, or CAH, driven by 21-hydroxylase deficiency, or 21OHD. The company also develops Encaleret, a small molecule antagonist of the calcium sensing receptor, or CaSR, which is in phase 3 clinical trial for treating autosomal dominant hypocalcemia type 1, or ADH1; and BBP-418, a glycosylation substrate pro-drug that is in Phase 3 clinical trial for treating limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). In addition, it engages in developing products for mendelian, oncology, and gene therapy diseases. BridgeBio Pharma, Inc. has license and collaboration agreements with the Leland Stanford Junior University; and Leidos Biomedical Research, Inc. The company was founded in 2015 and is headquartered in Palo Alto, California.View BridgeBio Pharma ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Is Reddit Stock a Buy, Sell, or Hold After Earnings Release?Warning or Opportunity After Super Micro Computer's EarningsAmazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousRocket Lab Braces for Q1 Earnings Amid Soaring ExpectationsMeta Takes A Bow With Q1 Earnings - Watch For Tariff Impact in Q2Palantir Earnings: 1 Bullish Signal and 1 Area of ConcernVisa Q2 Earnings Top Forecasts, Adds $30B Buyback Plan Upcoming Earnings Advanced Micro Devices (5/6/2025)American Electric Power (5/6/2025)Constellation Energy (5/6/2025)Marriott International (5/6/2025)Energy Transfer (5/6/2025)Mplx (5/6/2025)Brookfield Asset Management (5/6/2025)Arista Networks (5/6/2025)Duke Energy (5/6/2025)Zoetis (5/6/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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PresentationSkip to Participants Operator00:00:00Afternoon. 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. Thank you. Operator00:00:21Before 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. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:01:38Good afternoon, and thank you for joining BridgeBio's q one twenty twenty five earnings conference call. This is Chinmay Shukla, VP of Strategic Finance at BridgeBio. Today, we will discuss our financial results for the first quarter of twenty twenty five and provide an overview of how we measure success in our business. We'll provide insight into the early results from the launch of Atruby as well as provide an update on our pipeline, which has three Phase three readouts expected in the next year, including our efforts in expansion indications such as in chronic hypoparathyroidism. Today's call will feature Neil Kumar, Chief Executive Officer Matt Houghton, Chief Commercial Officer and Tom Tremarki, President and Chief Financial Officer. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:02:22For the Q and A portion of the call, Anant Shreedhar, Chief Operating Officer of BridgeBio Cardio Renal and Justin Toh, Chief Executive Officer of BridgeBio Scheduled Dysplasia will also join. Following the remarks by our team, we will open up the call for Q and A. With that, I'll turn the call over to Neil. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:02:42Thanks to everyone on the line for the time and welcome to our first earnings call. We're grateful to open up another dimension of our dialogue with our investor partners. You collectively allowed us to deliver for the patients we serve and we look forward to your feedback on how to continually improve our discussion in this setting. Today, we know the star of the show is the Atruvio launch and the good news is that the brand is delivering for patients and the business. Dollars 36,700,000.0 in revenue this past quarter suggests that clinicians and patients are resonating with our differentiated clinical efficacy, safety and accessibility. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:03:18We continue to educate on our therapeutic impact, which comes as early as three months with a forty two percent relative risk reduction on cardiovascular hospitalization and mortality at thirty months, including a fifty percent reduction in cardiovascular hospitalization at that same time point. All these best in class point estimates are available at the lowest price point in the marketplace. There is much to like there. And we're aware that there is much work yet to be done. You'll hear about some of that work today as it pertains both to commercial tactics and further development work. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:03:51We add to Atrubia's good news the continued progress across our pipeline of three additional blockbuster products. Our trials in Limb Girdle Muscular Dystrophy Tab II, achondroplasia and ADH1 remain on track with low dropout rates, frequent data collection and positive site audits, all in preparation for an efficient NDA submission should the data be positive. Furthermore, key additional markets are being opened up. Our hypochondroplasia trial enrolled with incredible speed and we now have first patient in there. Our work with Incalorate in the hypothyroid setting positions it well for registrational trial, which if successful could pave the way for the first oral compelling solution in that space. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:04:33Before we move to discussion into further specifics regarding the business and since this is our first time hosting this type of call, I wanted to briefly address how we measure the performance of our business on an ongoing basis. It's nice that this quarter was a success, but there will be harder quarters I am sure. And through it all, you should expect for us to communicate consistently and in terms of net gains or losses in NPV. For instance, in this last quarter, our NPV increased by 9% given changes in the following variables: number one, the time factor of money, especially given the late stage of our portfolio number anticipated revenue driven by faster uptake of Atruvio than we anticipated and likely a slightly higher peak year share by volume than our market research had projected third, the success of our small study in HP and other sponsor setbacks in the space of oral HP medicines fourth, the early enrollment of our run-in of our hypochondroplasia study moving our timelines in for that program And fifth, a slight decrease in our model cost of capital given our recent convertible offering. There were NPV drags most prominently including tariffs. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:05:46However, these have a close to negligible effect at less than 1% of our overall NPV. Stepping back from NPV and as a reminder, our overall objective here at BridgeBio is simple, to maximize the positive change we can have in terms of quality adjusted life years for the patients that we serve as quickly as possible. We do so by creating as many meaningful medicines as possible as quickly as possible within three constraints. The first is that each program must have beautiful science, which in our vernacular means a high POTS driven by understanding a mechanism of disease optimally paired with a therapeutic mechanism of action that targets a well described genetic condition at its source. These types of programs historically have a three to four times higher probability of technical success than all comer drug R and D efforts. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:06:35Over time, in many programs, this elevated probability of technical success moves us from being a speculative lottery ticket to being something akin to an engineering company. The second constraint is that we strive for each medicine that we make to be first in class or best in class. Determining best in class can be tricky in the absence of double blind head to heads, but we approach this using a straightforward Bayesian approach. For instance, in TTR, if faced with decision as to what drug to use, a logical person would first interrogate the salient endpoint, death and hospitalization at a common time point. In this case, at thirty months, a relative risk reduction of forty two percent is a better point estimate as compared with any of the other products in this marketplace. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:07:20You would then ask how quickly does each drug take action? And you would find that the three month beginning of separation between placebo and active is the earliest point estimate of timing of impact in this field. So logically, BETRUVY is at worst no worse than other medicines. You would then look at safety. Here you would find little difference between small molecules but would observe that they do not have the safety signals some knockdowns have. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:07:47Vitamin A deficit, which by the way turns knockdowns into a once daily pill regimen, injection site reactions, the absence of impact on AFib, whereas both small molecules had meaningful reductions there, The imbalance of cardiac SAEs is observed in the INPATRO study and the as of yet unexplained imbalance in death on the rivusiran trial. You couple that with the overall finding that across multiple studies, TTR is a cross species conserved protein and that ever higher levels of TTR lead to ever longer lives and less disease over time. So logically, small molecule stabilization from these data is the safest approach. Finally, the logician might look at price only to discover that Etruevi has the lowest price point. We believe, given all of that, the choice is clear. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:08:39We apply similar reasoning in other competitive spaces like achondroplasia. Our final constraint is that each program we work on should be NPV positive to ensure firm level sustainability. We use all available levers during the R and D stage to optimize NPV, including time, cost, cost of capital and probability of technical success. The better our model is at generating economic value from projects, the further we can push into markets where others cannot extract adequate value in addition to being a better owner of obviously NPV positive projects. The fact that we will spend well under $100,000,000 per program to get each one of our potential blockbusters from the preclinical stage through proof of concept sets us up well for future growth that is economically attractive. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:09:28Okay. So that's our overall objective function with its intended constraints. And you heard the first and most important frame that we use to think about the business, which is NPV. There are other frameworks that we also use to look at the business, understanding the business by stage and capability, research, development and commercial, understanding the business in the context of the overall ecosystem, and understanding the business program by program. Using the by stage framework first, and as I mentioned earlier, we are pleased with the ongoing progress of our commercial launch and the building of a sustainable competitive advantage there, which means of course that our group is able to extract more profit from the asset than another would be able to. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:10:11I've also touched already on our ongoing development wins. On Discovery, our bread and butter, we continue to advance programs in genetic dilated cardiomyopathy and ADPKD. We also hold significant stakes in BridgeBio Oncology Therapeutics and Gondola Bio. In the latter, Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:10:29we expect Phase two data in Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:10:30our EPP program later this year, and we expect to generate up to six development candidates in 2025. From an ecosystem framing, the substrate for making genetic medicines remains incredible. We see that in the progress Gondola is making and more broadly with the depth of genetic disease starting points being produced and accessible at low price points. Finally, at a program level, Matt will have more to say about our commercial launch of Atruby. Our goal there, as a reminder, is 4,300,000,000 in peak year sales or about 30% of a $15,000,000,000 marketplace. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:11:07That gets delivered against approximately $380,000,000 of spend on the brand per year. Almost 25% of current spend is on further research and development activities like Act Early, which we think could continue to improve our medicines positioning and its ability to help patients in later years. The product of this spend also includes salient results like our variant data, where we obtained a hazard ratio of 0.41 with a p value of less than 0.02 in the sickest of patients, and new work we are doing regarding AFib, which is an emerging marker of disease progression, the first results of which we plan to present at ESC later this year. For Impregratinib, a first in class oral FGFR3 inhibitor in development for both achondroplasia and hypochondroplasia, the pivotal PROPEL3 Phase three is fully enrolled and we expect last participant last visit by the end of this year. We have also reached regulatory alignment with the FDA on our clinical development plan for Imfibratinib in children with achondroplasia from ages zero to three and we expect to initiate clinical development in this important age range by the end of the year. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:12:21Excitingly, we have also enrolled the run-in for our Phase two hypochondroplasia trial well ahead of benchmarks. For INCALARIT, a negative allosteric modulator of the calcium sensing receptor, our Phase three CALIBRATE study is fully enrolled. We expect last patient, last visit and top line results in the second half of this year. In parallel, CALIBRATE is also being studied in hyperparathyroidism and we announced today positive POC data for CALIBRATE in this key expansion indication. Preliminary evidence in the ongoing POC study has demonstrated that seventy eight percent of the first nine study participants were able to achieve normal blood and urine calcium levels within five days of ANCALARA administration. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:13:07Moving to BVP-four eighteen, an oral first in class disease modifying therapy in Phase III development for treatment of individuals living with Limb girdle muscular dystrophy type 2I. We have fully enrolled FORTIFY, a Phase three registrational placebo controlled study evaluating the safety and efficacy of BBP-four eighteen. The study includes a planned interim analysis to twelve months focused on assessing a surrogate endpoint biomarker glycosylated alpha dystroglycan to support accelerated approval in The United States. We anticipate top line readout from that Phase three interim analysis second half of this year as well. Finally, BVP-eight twelve is an AAV9 gene therapy in development for Canavan disease, an ultra rare neurodegenerative disease that usually leads to death in the first two decades of life. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:14:00Here, we are pursuing an accelerated approval approach using a single seamless registrational trial to bring this potential therapy to children with Canavan as quickly as possible. A meeting this month with the FDA reinforced the validity of our approach which centers around the use of urine NAA in tandem with other clinical measures and the suggested BLA filing that we have laid out by end of twenty twenty six. While this is not a very prevalent disease, we believe it's a great example of our model, targeting disease at its source and operating leanly to enable us to go after a well validated condition in an NPV positive manner. Okay, that's the final framing. To wrap up my comments, BridgeBio is executing well and importantly possessed a tremendously strong foundation for the future. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:14:47Number one, an unmatched collection of late stage genetic disease businesses with favorable economic prospects. Number two, a cadre of outstanding managers that are dedicated to their specific assets business and to BridgeBio number three, a diversity of stakes, including wholly owned assets and significant stakes in Gondola Bio and BridgeBio Oncology Therapeutics number four, first choice ranking with many academics when seeking a partner to discover and develop new medicines. And number five, a culture that is distinctive from most biotechs I have seen and that is decentralized independent thinking and lives the value that every minute counts for the patients we serve. We're excited to work with you, our investors to continue to build this company and to keep you up to date on our progress for patients. With that, I'll hand it over to Matt to walk through Atruby's commercial performance in more detail. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:15:42Thanks, Neil. To add to your comments, the launch of Etruevi is off to a strong and encouraging start. Let me walk through some of the highlights in terms of what we are seeing out in the marketplace and what we think is driving the rapid momentum we've built in just a few short months. The first highlight is the early uptake across all major prescriber and patient segments. As shared in our press release, two thousand and seventy two unique patients have received a prescription for Etrube through April 25, and seven fifty six unique health care providers have written at least one prescription. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:16:17This early adoption spans all physician segments, including large academic centers, regional amyloid clinics, high volume heart failure specialists, and community cardiologists. Importantly, we're seeing attributed use across the full spectrum of patients, wild type invariant, newly diagnosed, as well as switches from partial stabilizers. The fact that these different patient types are all gaining timely access and that prescribers are already writing for multiple patients gives us confidence that we're building a strong foundation for Atruvio. So let's discuss what is driving the uptake. It comes down to strong clinical endpoints paired with our transparent patient first support programs. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:17:00Starting with the clinical data, Atruvio is the only therapy for ATTR Centimeters that has demonstrated a separation from placebo in as early as three months. No other medicine has demonstrated that, and it's not just about efficacy. ATRUVY also positively impacts KCCQ scores, which directly correlate with better quality of life for patients. That's resonating deeply with physicians who want to make a meaningful impact on their patients' daily lives and patients who want to keep their functional activity levels. Second, let's look at hospitalization rates. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:17:35Atruvio is the only ATTR Centimeters therapy to demonstrate fifty percent relative risk reduction in cardiovascular hospitalization rates. This includes a statistically significant reduction in composite of mortality and hospitalization in the variant ATTR Centimeters population, a subgroup widely regarded as among the most difficult to treat. This was highlighted in the recent variant subgroup data presented at ACC. And third, affordability. Atruti is the most cost effective therapy in ATTR Centimeters available, 10% less expensive than Tafamidis and 50% less expensive than Vutrisiran. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:18:16It's not just about the WAC price, though. Atruevi has a free trial program for all patients regardless of insurance status and lifetime free drug for patients who participated in our pivotal trials. That matters to physicians, patients and payers, especially when coupled with the three month onset of treatment effect and fifty percent reduction in cardiovascular hospitalization at thirty months. No other ATTR Centimeters therapy checks all of these boxes. BridgeBio has a commercial model that is different, and it's working. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:18:50ATTRIVUE will be followed by three additional commercial launches in 2026 and 'twenty seven. What really differentiates BridgeBio, though, is how we bring products to market. There are no convoluted value based contracts, no vague promises of future rebates contingent on volume thresholds. What we offer is simple, transparent, and built around the people who matter most, patients and their care teams. And we're hearing from the field that this clarity, paired with strong clinical data, is helping accelerate adoption. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:19:22And once an HCP decides to prescribe Atruvi, we make it easy to get the medication to patients. Patients can receive Atruvi within forty eight hours. We have two world class specialty pharmacies in the Atruvi network and also allow physicians to fill prescriptions in their own in house pharmacies. All of this investment is paid off. We are gaining share in the crucial first line setting and our conversion to paid rate and time to paid prescription is well ahead of industry benchmarks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:19:52Looking towards the future, our focus heading into the rest of the year is as follows: continue marching towards our long term goal of 30% to 40% share of the ATTR Centimeters market and increase share in the critical first line setting, which is a leading indicator of launch success. While these early signs are encouraging and they reflect not just the strength of the product, but the preparation and the commitment of the broader BridgeBio team, we are also excited about what's ahead and remain focused on reaching as many patients as possible as quickly as possible. With that, I'll turn it over to Tom for a review of the financials. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:20:31Thank you, Matt, and good afternoon, everyone. Q1 twenty twenty five marked BridgeBio's first full quarter of net product revenue from the Attribute U. S. Commercial launch, major milestone for the company and a significant step forward in our evolution into a fully integrated genetic medicine business. I'll now walk through the financial highlights for the first quarter of twenty twenty five. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:20:50Please note that our commentary on today's call will focus on GAAP financial measures unless otherwise indicated. Total revenues were $116,600,000 for Q1 twenty twenty five and consist of attributed net product revenue and license and services revenue. Attributing net product revenue was $36,700,000 driven by strong demand across all major prescribers and patient segments. License and services revenue was $79,900,000 in the quarter, primarily driven by the recognition of the $75,000,000 regulatory milestone related to BEYONDRA's EU approval. Also in Q1, we received BEYONDRA approval in Japan for which we expect to recognize a $30,000,000 milestone in the second quarter. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:21:32Total operating expenses for the first quarter of twenty twenty five were $218,400,000 compared to $210,200,000 in the same period last year. This increase reflects our continued investment in the Atruity brand and our advancing late stage pipeline. Included in our total operating expenses was $29,400,000 of stock based compensation expense compared to $28,900,000 in the first quarter of twenty twenty four. Looking forward, we expect only modest growth in quarterly operating expenses for the remainder of the year with an offset to total cash burn provided by Atruvio sales in The U. S. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:22:04And BEYONDRA ex U. S. R and D expense for the first quarter of twenty twenty five was $111,400,000 compared to $141,000,000 in the same period last year. This decrease was largely due to the strategic carve out of our oncology business and early stage research programs, allowing us to focus resources on the Atruvian launch and late stage pipeline. SG and A expense for the first quarter of twenty twenty five was $106,400,000 compared to $65,800,000 in the same period last year. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:22:33This increase was driven by the full scale commercial rollout of Atruby, including field team deployment, payer engagement and patient support infrastructure. Restructuring expense for the first quarter of twenty twenty five was $600,000 compared to $3,400,000 in the same period last year. We ended the quarter with 5 and $40,600,000 in cash and cash equivalents, which does not include $105,000,000 in regulatory milestone payments anticipated in Q2 for ex U. Approvals of BEYONDRA. We believe we are well financed towards the continued execution of Atruvio launch and deliver on key milestones from the pipeline this year. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:23:10We look forward to sharing additional commercial updates throughout the year with the top line data from our three Phase III programs over the next year with ADH1 and LGMD2I in the second half of twenty twenty five and achondroplasia in early twenty twenty six. With that, I'll turn the call back to Chimai. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:23:26Thank you, Neil, Matt and Tom. I'll now hand it back to the moderator to open the line for questions. I would like to request our analysts to limit themselves to one question each so that more people get a chance to ask their questions. Operator00:24:06Your first question comes from the line of Salim Syed of Mizuho. Please go ahead. Salim SyedManaging Director, Equity Research at Mizuho Securities00:24:12Great. Congrats on the quarter guys and congrats also on your first earnings call. Maybe just one for Neil or Matt here. Obviously, the quarter came in healthier than I think people had thought going into the print. And I appreciate the commentary that you provided, Matt, on some of the dynamics there. Salim SyedManaging Director, Equity Research at Mizuho Securities00:24:33But any sort of granularity you could provide on the tailwind and what you really deem that's working well for you here? Thank you. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:24:40Yes. Maybe I'll kick it off. Thanks, Salim. It's probably too early for some of the higher cost commercial tactics that we've invested in to show ROI right now. So hearteningly, I think a lot of the demand we're seeing to date really is a product number one of the differentiated clinical efficacy. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:24:58We have as a reminder and you know this, the earliest separation and point estimate that we've seen in the field at three months, forty two percent relative risk reduction against ACM and CVH at thirty months. Again, the best point estimate we've seen at thirty months coupled with that fifty percent reduction in hospitalization, which turns out to be a hugely meaningful measure for patients who both want to live longer, but also live healthier. So I'd say that's point number one. Point number two, as you saw as well from the Pfizer call this morning, continued market growth, right? We're one fifth diagnosed in this space, some 50,000 or so patients diagnosed. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:25:34We think there's 250,000 to 300,000 in The U. S. Alone. And so physician education coupled with there being a variety of therapeutic interventions now available, I think is driving that growth. That I think is another tailwind. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:25:48And then the third is the access programs that Matt talked about. The team, think, done a terrific job of ensuring that patients, when they are prescribed Vitruvi, can get the medicine and stay on the medicine as long as they need to. So those would be the three salient drivers. I'd say the final thing is a little bit of what a physician described to us the other day as Karma. Obviously, we're the only sponsor in this space that gave free drug for life for their trial participants. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:26:15Unfortunately, others decided not to. We're also the only sponsor in this space running a primary prevention study, which I think many physicians view as the ultimate in trying to catch patients in this mass action condition as early as possible to do as much as we can for their condition. So those types of things, I think, over a long period of time will stand us in good stead as sponsor here in competitive space. I don't know, Matt, if you'd add anything. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:26:40No. I think to miss the people. We've spent a lot of time putting the team together, both internally in the field, to make it as easy as we can for both prescribers and for patients, and I think you're seeing the good results of that. Salim SyedManaging Director, Equity Research at Mizuho Securities00:26:55Great. Thanks, guys. Congrats again. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:26:58Thanks, Wayne. Operator00:27:00Your next question comes from the line of Tyler Van Buren of TD Cowen. Please go ahead. Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:27:07Hey guys. My congrats on the stellar Atruvu result as well and the ongoing progress of the pipeline. So again the $37,000,000 of Atruvu sales far exceeded expectations. So when you say that the paid conversion rate is well ahead, can you help quantify that? Was the time to pay quicker than a month for some patients? Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:27:26And how much stocking was there in the quarter? Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:27:30Hey, Tyler. Great to hear from you, and thanks for the question. I'm going to pass it on to Matt to comment more on conversion. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:27:37Yeah. Thanks for the question. You know, we're really happy with how conversion is tracking, and that's for both free trial to paid and also commercial prescriptions to paid. Everything regarding conversion is consistent or better than historical launches that we've studied. I will just point out a free trial acts like a normal prescription. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:27:58A HCP writes it, the pharmacy processes it, and the patient gets it. And we designed our network specifically with conversion in mind, and that's what makes the access so easy. Our goal remains the same, 30 to 40% peak share. It takes about three to six years usually to hit. We're hoping we can do that a little bit faster. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:28:21In regards to your channel and inventory question, I mentioned we do have a limited distribution network that allows for very frequent ordering, and it allows our customers, our distributors to have just in time inventory. So there's no need for them to really hold large quantities. And so typically, I would say that this small group of distributors holds about one to two weeks of inventory. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:28:45Hey, Tyler. This is Tom. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:28:46Let me just put a finer point on the inventory question. As I mentioned in Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:28:49the prepared remarks, the sales in the Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:28:51quarter were primarily driven by demand. So we've seen only a minor impact of inventory on total sales in the quarter. So real really demand driven here. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:28:59Yes. Thanks, Tyler. I know you had another question. Happy to answer more about this or go to your next question. Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:29:08No. That's great. Thank you. Operator00:29:13Your next question comes from the line of Manu Foroohar of Leerink Partners. Mani ForooharSenior Managing Director at Leerink Partners00:29:17Congrats Mani ForooharSenior Managing Director at Leerink Partners00:29:21on the quarter. Clearly, it blew out expectations despite having shown pretty good scripts repeatedly. I wanna dive in on the script numbers. I'm looking at the incremental scripts on a weekly basis through that first update on January 10, was in the sixties per week, and then through the update you gave on on incremental basis on February 17, that was running north of a hundred scripts a week and, again, running through from twelve and four four weeks into launch and twenty two weeks into launch, I e, from February 17 to April 25, you're still running at about a 10, hundred nine scripts per week as reported. I know it's just math, and there's a lot of nuance that goes into script reporting. Mani ForooharSenior Managing Director at Leerink Partners00:30:03Could you give us a sense of what the the character and velocity of new of new patient scripts you're seeing right now, and so what is the but what is the kind of direction of travel that's there? And I have a follow-up question. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:30:19Great. I can take that. Thank you for the question. I mean, I think starting out, the thesis really, again, it remains unchanged. TTR levels go up with the Truvy, and it's the only near complete stabilizer on the market. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:30:32When we sort of take that thesis and then dive into, okay. Well, what's happening, and then how do we think that's gonna impact things going forward? The month over month growth rate in the treatment naive section has been very strong, and that's been across all segments. So this is in the large centers. This is in the community. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:30:50It's across all types of patients, variant, wild type. There hasn't been a sort of one area or another that's done better. We've sort of seen this across the board. And so then when we look at sort of Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:31:04the two groups, we have Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:31:05the treatment naive patients. That's our focus, and that will continue, we believe, to grow over time as it has been. Then you have the switch patients. Of course, when we launched, we had a % of the switch share because we were the only option you could switch to. As new now with new entrants in the market, that's going to evolve over time because there are now more choices. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:31:28And so I think that the data and how we report will evolve over time as well based on that, but that's kind of where we are and how we see it moving forward. Mani ForooharSenior Managing Director at Leerink Partners00:31:40Great. That's helpful. And I have sort of a non TTR question to everyone's surprise. When you think about limb girdle data coming later on this year, which obviously have we've we've been discussing a number of calls. This is not the first time you guys have brought it up. Mani ForooharSenior Managing Director at Leerink Partners00:31:58We talked about it at my conference a couple years running, about the filability of that dataset or whether a later dataset from the same study will be required. Do any of the changes of FDA concern you around your ability to file on a biomarker? Do you think you have to show a distinct level of clear clinical improvement on a on a non biomarker slash functional basis? Like, where where are we in terms of the filability on that biomarker for limb girdle? Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:32:29Yeah. I can I can take that, Mani? You know, we haven't met with the agency of late on the LGMD2I program, but we have had some close to 10 meetings now over the course of the last month as it pertains to either pipeline at Gondola or pipeline here at Bridge, probably the latest meeting was in and around the Canavan program. And I have seen nothing but I would say a positive inclination toward trying to get first in class medicines that target path of mechanism like our drug for LGMD2I onto the marketplace as quickly as possible to benefit the children that are suffering from these conditions. And so I don't think the rather clear guidance that we've gotten from the agency to date in and around fallibility around glycosylation of ADG is going to change. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:33:23I really don't. I have been on the record saying, I think it's going to be a problem if we go the right way and hit our primary endpoint on ADG, but we go the wrong way on all clinical measures. Obviously, don't think that's going to be the case based on what we observed in Phase two, which was albeit an open label study against natural history where we saw improvements in measures of ambulation and other clinical outcomes. So I do believe these things will move toward the positive or at least a few will move toward the positive. Obviously, modified North Star, North Star, which is historically been the gold standard in these conditions, it's all noise over the course of the first twelve months. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:34:03So whether the point estimate goes one way or the other, I think natural history has made that very clear. And that is why we're running the confirmatory trial. This is effectively a nested trial design that goes on for another two point five years post the readout later this year. So I mean, long story short, yeah, we continue to believe that this is going to be an approval endpoint in terms of ADG glycosylation increase. Mani ForooharSenior Managing Director at Leerink Partners00:34:31Awesome. Thanks, guys. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:34:34Thanks, Mike. Operator00:34:35Your Operator00:34:39next question comes from the line of Tyler Van Buren of TD Cowen. Please go ahead. Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:34:48Hey guys. Yes, just had a second question that I meant to ask. But just the ADH-one and Limb girdle Phase III is reading out during the second half of the year, clearly have a high probability of success. So can you it would be great to hear you elaborate on why investors should be excited about and more importantly focus on those opportunities beyond the ongoing Atruvio launch. What do Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:35:05you think the magnitude of those opportunities could be? Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:35:10Yes. Good question, Tyler. As I was suggesting, continue to be heartened by both the clinical operational positioning of LGMD2I, ADH1 and our achondroplasia trials as well as the potential to help a broad swath of patients. And I think from an investor standpoint, one has to consider the sheer size of these marketplaces, LGMD2I, as we've discussed, some seven thousand to eight thousand patients between The U. S. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:35:36And EU. That's a substantial market size as compared to many of the other muscular dystrophy programs that you see out there at the price points that are attended in the space. And with ADH1, a rather much more prevalent condition maybe ten thousand to twelve thousand patients in The United States alone, as suggested by statistical genetics methodology, some four thousand or so already identified to date. That's going to be really a program associated with the market build and finding new patients. And we've already shown that we can do that in some of the sequencing efforts we've undertaken within the non surgical hypoparic community where we're reliably finding something twenty percent to twenty five percent of patients actually harbor the gain of function mutations in the calcium sensing receptor. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:36:24So I think two very exciting commercial opportunities, two very exciting opportunities for first in class medicines for patients there. And then I don't think I need to belabor the achondroplasia hypothesis where we feel we have an exciting oral best in class potentially best in class option that could provide differential safety, differential efficacy because it targets this well described condition at its source driving differential both changes in growth and then also importantly impact on parameters that this community cares a great deal about like proportionality and the like. And you know the size of that market from the Box of the launch that's ongoing. I think all three very exciting opportunities. Tyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD Cowen00:37:10Thank you. Operator00:37:15Your next question comes from the line of Biren Amin of Equity Research Healthcare. Please go ahead. Biren AminManaging Director & Senior Research Analyst at Piper Sandler Companies00:37:22Yes. Hi. Thanks for taking my questions. Congrats on the quarter and really good launch out of the gate. I guess my question is what's resonating with health care professionals as it relates to the Truvy launch? Biren AminManaging Director & Senior Research Analyst at Piper Sandler Companies00:37:34And what are the biggest hurdles that you're seeing for adoption? And then maybe a second question. What was the gross to net for the quarter? And any impact that you've seen from the Part D redesign? Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:37:45Hey, Viren. Thanks for the question. I'm going to pass it on to Matt to discuss the HCP piece and then also to Tom to discuss the gross to net piece. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:37:56Yeah. Thanks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:37:57And I guess there's sort Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:37:58of two parts to this. You know, the feedback from the physician segments has been positive as we've discussed. Our messaging around, you know, we call it the three forty two fifty, but that ability to separate as early as three months and getting results around the hospitalization, all cause mortality, that we've described. Physicians wanna see a drug work really fast, and they wanna be able to tie it to hard hard outcomes. Of course, patients do too, but this is what gives people confidence. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:38:31And so those messages have been resonating extremely well, and I think that's resulted in physicians trying Atruvite, but then also then repeating it. Right? Those are the reasons that you sort of try a medication, and then you when you see how well people are doing on it, then that encourages you to try it again. So we've seen a lot of repeat prescribers across a lot of the different segments as well. And I don't think our expectations were otherwise or are are going to change anytime soon. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:39:01We have very strong data package, and we also have very strong programs to help patients get on the medication once that prescription has been written. And then I'll pass it to Neil to add on that. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:39:11Yeah. Maybe I'll just elaborate on that for a second before I throw it over to Tom. You know, I think the the, ever increasing, availability of data, like most recently, Varun, I think we've talked about the variant data. The fact that you could achieve a hazard ratio of 0.41 with statistical significance in that relatively small sub population and as someone mentioned earlier, the sickest of sub populations continues to reinforce that differential levels of stabilization can lead to ever better outcomes. And we're starting to find that that's resonating. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:39:44We've got a bevy of serum TTR associated literature coming out suggesting that ever higher levels of serum TTR correlate with ever lower levels of downstream hospitalization and mortality. The connecting of the dots between ever better stabilization and all of these downstream outcomes, think is what's starting to resonate with the physician community on top of what Matt suggested the backbone, which is the three forty two fifty. Tom, you want talk about GTN? Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:40:12Yes. Sure. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:40:12On gross to net specifically, so as we've said before, the way to think about this is the floor is going be the mandatory IRA rebate of 20%. And on top of that, you're gonna add something something like you'd see in other con categories where contracting is not really happening. So that's what we're seeing here. I would say, given where we are in the launch early innings, we should expect some variability here quarter to quarter. This quarter, gross to net trended slightly favorable versus what we were expecting. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:40:41We also saw a slightly lower use of our first month free program versus what we were expecting, and we saw a slightly lower use of our patient assistance program than what we're expecting. These three things together actually converged and caused slightly better net revenue per per unit than than what we were expecting, but we expect all of this to normalize over the course of the year. Biren AminManaging Director & Senior Research Analyst at Piper Sandler Companies00:41:03Great. Thank just Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:41:04to add that, you know, the results are reflective of strong strong underlying demand for a true b and and the execution of our commercial team. As Matt mentioned, not a lot of inventory or anything like that. Biren AminManaging Director & Senior Research Analyst at Piper Sandler Companies00:41:18Thanks. Perfect. Operator00:41:22Next question comes from the line of Cory Kasimov of Evercore. Please go ahead. Cory KasimovSenior Managing Director at Evercore00:41:29Good afternoon guys. Thanks for taking the question. So it's great to see that Ruby is off to such an impressive start, you kind of alluded to this in a prior response. But now that you're on the market for over a quarter, how are you thinking about new patient starts for the category going forward? I know previously, you've talked about numbers like 2,000 to 3,000 restarts per quarter, but that's already looking pretty conservative. Cory KasimovSenior Managing Director at Evercore00:41:50So any, kind of new color there would be appreciated. Thank you. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:41:55Yeah. Hey, Corey. Thanks for the question. I I think you're kind of thinking about it like we're thinking about it. It it does seem to keep going up every quarter. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:42:03And if you look historically, you know, that's no different. I think it is ramping a bit faster, but that also makes sense because you're getting new products in the market. So the more companies that launch a product into a space, that creates a higher share of voice, and I think that gets people educated either to go get screened or for physicians to think to themselves I mean, if you're a cardiologist and you have PSPF patients and you're not thinking to yourself, hey, some of these must be ATTR Centimeters patients, all of these companies are discussing it, educating, talking about it. It gets people looking, and if you look, you find it. It's it's not that uncommon. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:42:43You know, most cardiologists have some patients that need to be treated. So I think that, you know, we don't see that stopping anytime soon. The market could easily be a $20,000,000,000 market, and we're not there yet. So there's still a lot of patients who are out there who have not been diagnosed, but I think you're going to see continued high numbers of people being diagnosed now that that interest is just continuing to grow. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:43:08Yeah. And, Corey, just to add one last thing. You know, a lot of the new diagnosis is coming from the high volume heart failure clinics that Matt mentioned in his remarks, and, obviously, an oral small molecule stabilizer is is a great fit for those patients. Cory KasimovSenior Managing Director at Evercore00:43:23Absolutely. Very helpful. Thank you. Operator00:43:29Your next question comes from the line of Greg Harrison of Scotiabank. Please go ahead. Greg HarrisonDirector - Biotechnology at Scotiabank00:43:35Hey, good afternoon, guys. Congrats on the huge start to the launch, and thanks for taking our questions. So in our initial modeling conversations, with you guys, our takeaway was that your expectation was for initial uptake to come, you know, primarily or almost exclusively from newly diagnosed patients. But to get to the revenue number you've reported, you have to get most of them by our math. So assuming that's not the case, you know, is this a a function of, much larger market growth than you expected, or, are you getting a large percentage or or maybe even most of your patients as tafamidis switches? Greg HarrisonDirector - Biotechnology at Scotiabank00:44:18And if that's the case, how do you expect, this trend to evolve from here? Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:44:23Hey, Greg. Thank you so much for the question. So I think as we have said consistently, our focus at launch has been the treatment naive market. Very early on, we got a few more switch patients than we expected, but, you know, that started to normalize. Focus continues to be new treatment naive patients, and I think Matt mentioned in his remarks that there we are seeing consistent monthly growth, you know, gradually. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:44:50In terms of what's driving the the number, I think it's it's sort of all of the above. Right? I think it's a little bit of the market growth, you know, obviously, strong demand and and strong conversion. Maybe I'll throw it on to Matt, and and he can talk a little bit more about the factors, you know, driving conversion and and the market size. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:45:09Yeah. No. I think you I think you hit it well, Chinmay. I don't know that I would add that much. You know, it's a little tricky when you try to figure out who a switch patient is. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:45:19You know, they can they look like a new patient, most of the time. So I think it's a little you have to be a little careful trying to determine who's a switch and who's new. Our focus is on the newly diagnosed. We do see switch patients come in, and sometimes we can tell that they're a switch patient. Other times, it's not clear. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:45:38But I think as you think about the rest of '25 moving into '26, I think the market continues to grow. It's been growing double digits now for quite a long time, and this past quarter, one of the best we've seen. I would not expect that to disappear anytime soon. There will be switch patients who want a Truvy, and there will be a lot of newly diagnosed patients that want a Truvy for all the reasons we've discussed, whether it's the the data itself, the programs we offer. You know, I I I think we're very optimistic about all of that. Operator00:46:11Your Operator00:46:16next question comes from the line of Paul Choi with Goldman Sachs. Paul ChoiAnalyst at Goldman Sachs00:46:25And congratulations on knocking it out of the park in your first quarter here on the launch. I want to just shift gears for a minute, maybe just ask a policy question, which is to think about as a true regrowth in scale over the coming years here or this year and next year, as well as you start to get sales from Europe from Bayer and on BIANTRA and AstraZeneca in Japan. Could you maybe just help us think through where your IP is domiciled and just sort of the tariff implications and just sort of the royalty streams that you'll be getting from your ex U. S. Partners and just sort of how that ultimately affects your margin and your sort of profitability profile? Paul ChoiAnalyst at Goldman Sachs00:47:06Any color there or directional guidance would be helpful. Thanks. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:47:11Hey, Paul. Thanks for the question. This is Tom. Yes. So as Neil indicated in his prepared remarks, we're fortunate to have very little impact from any of the tariff discussions that are ongoing. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:47:22We've done a pretty deep dive on this. As you know, the pharmaceutical has been exempt from the reciprocal tariffs, but we've also looked at the IEP or IEPA and what's been said in public around the potential two thirty two tariffs affecting the industry. When we put all that together based on our supply chain, we see very, very minor impact. That's because Etruvia is made here in The USA. And then we're, of course, an American company, and we have all our IP domiciled here in The US. Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:47:48So overall, very minor impact to the business. I'm not sure I understood the question on the royalties and how that relates, but that's off the top line revenue number. So obviously, we're getting money coming to us as before any any implication on tariffs that would be on Thomas TrimarchiPresident & CFO at BridgeBio Pharma00:48:06their end, but maybe I didn't understand the question. Paul ChoiAnalyst at Goldman Sachs00:48:09No. That that that that makes sense on the ex US business. Operator00:48:19Your next question comes from the line of Anupam Rama of JPMorgan. Anupam RamaAnalyst at JP Morgan00:48:23Congrats Anupam RamaAnalyst at JP Morgan00:48:29on the quarter with Atruby. I wanted to just pop in with a very quick pipeline question. So you shared some data today on the chronic hypoparathyroidism, indication. So what gets you excited about this opportunity, particularly from you talked about Neil from an NPV perspective? How does that all fit in? Anupam RamaAnalyst at JP Morgan00:48:45Thanks so much. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:48:47Hey, Anupam. Thanks for the question. We're gonna drive it to Neil to talk about the NPV, then Anand can talk more about the data and our exciting plans for the phase three in HP. Neil KumarCo-Founder, CEO & Director at BridgeBio Pharma00:48:57Yeah. I mean, from an NPV standpoint, Noop, I think you know that this is an exciting extension population, quite a bit larger than ADH1 itself with actually a pretty reasonable price point as well given where Ascendis ended up pricing their medicines. So there's a variety of different ways for us to take advantage of the opportunity now that many of the oral competitors have fallen by the wayside. I'm going to actually pass it over to Anant to talk a little bit about the exciting data that we just posted. Ananth SridharCOO - Cardiorenal at BridgeBio Pharma00:49:26Hey, Anantam. Great question. Ananth SridharCOO - Cardiorenal at BridgeBio Pharma00:49:28Thanks for your interest in this program. We so as you mentioned, we we reported data from the first nine participants with postsurgical hypoparathyroidism that were treated with Incalarat. It normalized blood and urine calcium concomitantly in seventy eight of these participants and serves to be the, important oral option for these patients seeking to resolve calcium homeostasis. So we think that this could be a treatment changing or a paradigm changing treatment, and we will advance development towards registration for this program. And in terms of the NPV or the market opportunity, Neil mentioned, this is about a seven to eight times larger marketplace than the ADHD market alone, so it could grow and expand the the presence of Incalorate as as we continue to investigate molecule. Anupam RamaAnalyst at JP Morgan00:50:22Thanks so much, guys. Operator00:50:28Your next question comes from the line of Ellie Merle of UBS. Please go ahead. Eliana MerleAnalyst at UBS Group00:50:33Hey, guys. Thanks for taking the question and congrats on the quarter. What you're seeing so far in terms of commercial trends since Ambutra's approval. You have a few weeks of experience now with this so far. So, I mean, I guess, specifically, was the rate of unique patient prescriptions consistent with what you saw in February and March? Eliana MerleAnalyst at UBS Group00:50:53Did you see an increase by an April associate of the broader prescriber base? Or have you maybe seen a dip in the rate of new unique patient starts just with the launch of a competitor? And any sort of high level commentary on how you're thinking about positioning? Are there certain segments where you see potential greater uptake or advantages in terms of your use? Thanks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:51:18Sure. This is Matt. Thank you. For the second half of your question, the audio was a little garbled. So let me answer the first one, and then if you want to repeat the second one, I'm happy to address that as well. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:51:30Your your first one regarding Ambutra, you know, I there's definitely a place for lots of choices in this market, and I think as a company, we're obviously happy when patients have additional choices. In terms of where Ambutra is going to be placed, you know, they seem to be earmarked for mixed phenotype at the moment. That's probably ten percent of the overall market. You know, their variant data wasn't stat sig, and they're very expensive. So it's twice as expensive as a Truevi right now. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:52:05And they have to compete, obviously, with our three forty two fifty, which has been pretty successful. So I don't I don't know where that's going to land for them. I I think they have to figure out their pricing. You know, if you're gonna charge double, you you need to have better results. And, you know, I think you can ask them to to talk about that. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:52:26I'm sure they they'll have opinions on that. But right now, it's early, but we're not seeing a lot of uptake outside of the mixed phenotype. Eliana MerleAnalyst at UBS Group00:52:36Got it. And then just maybe this was the part of the question that broke off. Let me know if you can't hear me. But just in terms of the rate of unique patient prescriptions, I guess, you seen any change in that, since the approval of Ambutra? So, you know, for instance, if you saw a dip in the rate of new unique, patient prescriptions in April, or let's say now that you have a broader prescriber base, you've seen a similar rate in new patient prescriptions or even higher. Eliana MerleAnalyst at UBS Group00:53:07Thanks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:53:09Yeah. So the April data, I probably wouldn't be able to comment on. I mean, you know, they were sort of out two weeks in q one, and now, you know, we we've picked up some data. We see some of the same stuff that you guys see. The trouble is, you know, even you know, it's buy and bill, and so, you know, they're they're trying to convince a community physician to put out over a hundred thousand dollars per injection. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:53:35You know, the vitamin a part's cheap. So, you know, from a cost perspective, that's fine. You still have to take that every day. But the that out of pocket for the doctor, they have to cash flow that. So they have to put that money out, and then they have to wait to get reimbursed. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:53:49Well, if you start stacking up a lot of patients, that's a lot of money, and, it gets pretty expensive. So we haven't seen it yet. It doesn't necessarily mean it is or isn't happening. You know, I I think you'd have to ask them. Maybe they can do what we did and throw out some early numbers on what the first month of launch looks like. Eliana MerleAnalyst at UBS Group00:54:12Got it. Thanks. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:54:16No. Thank you. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:54:17Appreciate your question. Operator00:54:18Comes from the line of Jason Zemanski of Bank of America. Please go ahead. Jason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:54:23Great. Good afternoon. Congratulations on the quarter and thanks for taking our questions. I wanted to return to the question of segment growth for Atruby, if I may. It sounds like you expect the contribution from switches to slow at some point. Jason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill Lynch00:54:38But what does that look like over the near term? I mean, do you have a sense of how quickly you may be going through a bolus of, I don't know, refractory patients versus those as you mentioned, you know, are looking for a stronger stabilizer because they believe in the the better outcomes over time? Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:54:55Hey, Jason. Thanks for the question. I think that high level, I can I can say a couple of things and then Matt Matt's gonna add more details? But as we have said all along, you know, we're not seeing any bolus or anything like that. I do think that the focus of our launch is treatment naive, and there we're seeing consistent monthly share growth, and we expect that to continue. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:55:18We had a % share in the switch population, and and, obviously, that's going to evolve now that there's a competitor. So that's sort of how we are thinking about it. Obviously, it's very early to say, and and we look forward to seeing how the next quarter goes. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:55:33Yeah. And I'll just add. I mean, I agree. We didn't see a bolus. I mentioned earlier, it's a little tricky to absolutely know if someone is a switch or a newly diagnosed. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:55:44We we don't spend a lot of time sort of thinking about it from that perspective. If patients wanna get a Truvy, we try to make sure they can get it for, you know, whoever they are, newly diagnosed or switched. In terms of what that looks like over time, I I think that's hard to predict. You can take the number of patients on to Famidis. You can add on a progression rate of whatever you think is correct and then kind of model that out over time. Matthew OuttenChief Commercial Officer at BridgeBio Pharma00:56:11I think that's probably the best approach of any. Operator00:56:16There are no further questions at this time, and that concludes our q and a for today. I will now hand this call back over to the company. Please go ahead. Chinmay ShuklaVP - Strategic Finance at BridgeBio Pharma00:56:25Thanks everyone for your questions today. We appreciate your interest in BridgeBio and look forward to updating you again next quarter.Read moreParticipantsExecutivesChinmay ShuklaVP - Strategic FinanceNeil KumarCo-Founder, CEO & DirectorMatthew OuttenChief Commercial OfficerThomas TrimarchiPresident & CFOAnanth SridharCOO - CardiorenalAnalystsSalim SyedManaging Director, Equity Research at Mizuho SecuritiesTyler Van BurenManaging Director, Senior Biotech Equity Research Analyst at TD CowenMani ForooharSenior Managing Director at Leerink PartnersBiren AminManaging Director & Senior Research Analyst at Piper Sandler CompaniesCory KasimovSenior Managing Director at EvercoreGreg HarrisonDirector - Biotechnology at ScotiabankPaul ChoiAnalyst at Goldman SachsAnupam RamaAnalyst at JP MorganEliana MerleAnalyst at UBS GroupJason ZemanskyVice President, Equity Research, Biotechnology and Pharmaceuticals at Bank of America Merrill LynchPowered by