Fubotv earnings beat by $0.10, revenue topped estimates
BridgeBio Pharma reported its second-quarter 2025 earnings, showcasing a significant increase in revenue but missing earnings expectations. The company recorded a revenue of $110.6 million, surpassing the forecast of $99.72 million by 10.87%. However, the earnings per share (EPS) fell short, posting a loss of $0.95 compared to the expected loss of $0.75. According to InvestingPro analysis, the stock appears overvalued at current levels, with a FAIR overall financial health rating. Despite the mixed results, BridgeBio’s stock saw a 3.06% increase in after-hours trading, closing at $47.75.
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Key Takeaways
- BridgeBio Pharma’s Q2 2025 revenue increased dramatically from the previous year.
- EPS missed forecasts, with a larger-than-expected loss.
- Stock price rose by 3.06% in after-hours trading.
- The company maintains a strong cash position with $756.9 million.
- Atruvi product launch shows significant growth potential.
Company Performance
BridgeBio Pharma demonstrated robust performance in the second quarter of 2025, largely driven by the success of its Atruvi product. The company’s revenue surged to $110.6 million from a mere $2.2 million in the same period last year, reflecting its strategic focus on expanding its product offerings. InvestingPro data shows an impressive gross profit margin of 95.35% and analysts expect 86% revenue growth for fiscal year 2025. This growth is set against the backdrop of an expanding market for ATTR cardiomyopathy, which is expected to reach $15-20 billion at its peak.
Financial Highlights
- Revenue: $110.6 million, up from $2.2 million YoY.
- EPS: -$0.95, missing the forecast of -$0.75.
- Operating expenses: $244.8 million, an increase from $177.7 million YoY.
- Cash and equivalents: $756.9 million.
Earnings vs. Forecast
BridgeBio’s revenue exceeded expectations by 10.87%, marking a positive surprise for investors. However, the EPS of -$0.95 was below the forecasted -$0.75, resulting in a 26.67% negative surprise. This discrepancy highlights the company’s ongoing investments and operational expenses as it scales its business.
Market Reaction
In response to the earnings report, BridgeBio’s stock price increased by 3.06% in after-hours trading, reaching $47.75. This rise reflects investor optimism about the company’s revenue growth and future potential, despite the EPS miss. The stock has delivered remarkable returns, with a 79.34% gain year-to-date and nearly 93% over the past year according to InvestingPro data. Trading near its 52-week high of $49.77, the stock has shown strong momentum, with analyst targets ranging from $41 to $95 per share.
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Outlook & Guidance
Looking ahead, BridgeBio is preparing for three potential product launches in 2026-2027, each with a market opportunity exceeding $1 billion in the U.S. The company maintains strong liquidity with a current ratio of 4.57, as reported by InvestingPro, providing financial flexibility for its expansion plans. The company is focused on expanding its Atruvi market presence and is anticipating top-line results for its ADH1 and LGMD2I programs in the fall of 2025 and early 2026, respectively. Analysts maintain a strong buy consensus, reflecting confidence in the company’s growth trajectory.
Executive Commentary
Neil Kumar, CEO, expressed excitement about BridgeBio’s transformation into a fully integrated biopharma company, emphasizing the strategic importance of making Atruvi accessible to all patients. Matt Houghton, Chief Commercial Officer, reiterated the company’s commitment to ensuring Atruvi’s availability to everyone who needs it.
Risks and Challenges
- Continued high operating expenses could impact profitability.
- Market competition in the ATTR cardiomyopathy space could affect market share.
- Regulatory hurdles for upcoming product launches could delay market entry.
- Economic conditions may influence healthcare spending and drug pricing.
Q&A
During the earnings call, analysts inquired about the dynamics of patient additions and the competitive landscape. Discussions also centered around the potential of BridgeBio’s pipeline, particularly for Incalorate in ADH1 and hypoparathyroidism, and the company’s strategy for generating real-world data.
Full transcript - BridgeBio Pharma Inc (BBIO) Q2 2025:
Conference Operator: Good afternoon. I will be your conference operator today. Before we begin, I would like to remind everyone that today’s call may contain forward looking statements within the meaning of the federal securities laws, including but not limited to statements about BridgeBio’s future operating and financial performance, business plans and prospects and strategy. These statements are based on current expectations and assumptions that are subject to risks and uncertainties, which could cause actual results to differ materially from those expressed or implied in these forward looking statements. For a discussion of these risks and uncertainties, please refer to the disclosure in today’s earnings release and BridgeBio’s periodic reports and SEC filings.
All statements made here are based on information available to BridgeBio as of today, and the company undertakes no obligation to update any forward looking statements made during this call except as required by law. With that completed, BridgeBio, you may begin your conference.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Good afternoon, everyone, and thank you for joining BridgeBio Pharma’s second quarter twenty twenty five earnings call. I’m Chilmai Shukla, Senior Vice President of Strategic Finance at BridgeBio. With me today are Neil Kumar, our CEO Matt Houghton, our Chief Commercial Officer and Tom Tremarchi, our President and Chief Financial Officer. During today’s call, we will cover our strong and accelerating launch of Etruevi. We will provide updates on our late stage pipeline, including the three key Phase three trials in ADH1, LGMD2I and achondroplasia.
Following our prepared remarks, we will open the call for questions. For the Q and A session, we will also be joined by Anand Sreedhar, Justin To and Christine Shu, who lead our Phase III programs. Before we begin, I would like to remind you that this call will include forward looking statements based on current expectations. These statements represent our judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially. With that, I’ll turn it over to Neil.
Neil Kumar, CEO, BridgeBio Pharma: Thanks to everyone on the line for the time. Welcome to our Q2 earnings call. As always, this is a forum whereby we can communicate to you both on salient results and business strategy. A key aspect of that is ensuring we are communicating the data you feel is important and that we’re doing it in a way that’s clear. On our last call, we spent a lot of time talking about how we make decisions internally and focused on an NPV led characterization of our business.
Your feedback which is important suggested that we spend less time on that and more time on the commercial medical and scientific performance of the business. We’re excited to do that today because there’s much to talk about as the business continues to deliver with the performance of Atruvi and as it positions itself for three Phase three readouts in the coming months across ADH1, LGMV2I and achondroplasia. The continued star of the show was Atruvi. The first and most important way we’ve monitored this launch to date is by the number of unique patient prescriptions, which now sits at an absolute number of 3,751 coupled with ten seventy four unique prescribers. We’re seeing growth in both the number of new prescribers as well as the depth of prescribing at their practices.
For those following week by week status, we’ve seen over 30% growth in weekly scripts. That acceleration is even greater than our internal projections given that this was the first full quarter with three players in the ATTR cardiomyopathy market. This prescribing ties to about one hundred percent revenue growth that we’ve seen in Q2, around $78,000,000 in global sales and $71,500,000 in U. S. Net sales.
And of course all of these numbers connect to the most important set of facts here. First, Atruvi is now positively impacting thousands of patient lives. Second, given the fact that all three bands in this space are growing, we are collectively doing a better job of identifying patients. And third, we offer what we feel is a best in class clinical and data package in the ATTR cardiomyopathy space. As discussed before, we have the responsibility to distribute etrubi as widely as possible so it can be used by any patient that needs it.
And to that end, we continue to have the most generous access programs in this space and are proud that the programs we pioneered are now being rolled out across the industry to improve access for patients. A second key aspect of our responsibility is to further investigate the existing data and perform novel clinical studies to better understand how Etruevi can maximally help specific patient profiles. In any disease category, it is precisely this type of subpopulation analysis that allows physicians to deploy the right drug for the right patient. In the case of Etruevi over the last quarter we published three seminal results, one of which deals with the scientific underpinnings of the disease and two of which touch on important subpopulations. The first of these publications further strengthens the connection between ever better stabilization and ever better clinical outcomes.
Recall that prior to the ATTRIBUTE Centimeters study, this connection had already been observed in three ways. First, by looking at the discrepant outcomes between eighty mg calf, which is a 50% stabilizer and twenty mg defamidis which is a 35% stabilizer. Second, by looking at the genotype phenotype of the disease and the associated rescue mutations. And third, through a small study that had been conducted by academics at BU suggesting that ever higher tetramerit stabilization as measured by serum TTR levels correlates to better clinical outcomes. A broad analysis of the ATTRIBUE dataset for the first time isolates the connection between ever higher levels of stabilization as measured by serum TTR levels which in turn are easily measurable in the clinical context and downstream clinical outcomes in both the wild type and variant context.
Importantly, as Moore et al. Show in a published paper recently, every one mg per deciliter increase in serum TTR leads to a five percent decrease in risk of mortality. Recent work published by authors in Europe, Menorvini et al, also observes this correlation at a quantitative level and they extend from it the recommendation that certain TTR be used to stage patients with cardiomyopathy. All of this is especially important given that patients who switch from tafamidis to apparatus in the context of the ATTRIBUE OLE all experienced significant increases in serum TTR with an average rise of 3.4. Moving to key subpopulation analyses, the first subpopulation we wanted to look at was the variant subtype.
As KOLs have been asked and published patients with the most common cardiomyopathy variant V122I have a fifty percent probability of survival as compared to even wild type ATTR cardiomyopathy patients. As some of you on the call may remember, Acoramidis has a superior bonding profile compared to other stabilizers not only in wild type patients but also in the variant population as suggested by two prior publications and reinforced by an upcoming paper that has been submitted for publication that details both biochemical and clinical outcome advantages of Etruevi as compared to other stabilizers in the variant population. Once again, we’ve been able to establish the advantage of that greater stabilization in this subpopulation and we’re able to publish a fifty nine percent hazard reduction in time to first event CVH or ACM that is associated with a p value of 0.011. To our knowledge, this is the greatest degree of risk reduction that has been observed at the varying population with the highest degree of statistical significance in the field. Finally, we published on another important subpopulation, namely patients with cardiac arrhythmia involvement.
It turns out that this population is likely more common than certainly I would have thought at the outside of our studies in ATTR cardiomyopathy. Indeed more than fifty percent of the population within ATTRIVUE had AFib allowing us to ask the following questions. Does treatment with ATTRIVUE reduce the consequences of AFib and might it even stave off the occurrence of AFib? It turns out importantly that it is able to do both. We observed a forty three percent reduction in risk of CDH associated with cardiac arrhythmia and a seventeen percent reduction in the onset of Afib.
Again, we believe this is the best data in the AFib subpopulation published where other stabilizers appear to have had some effect and where knockdowns to our knowledge based on published AE tables appear not to have had benefit on AFib occurrence. All of this research is complemented by our ACT early trial. In discussions with clinicians and healthcare policy leaders alike, I’ve been struck by the enthusiasm associated with this CORAIGOUS trial that seeks to marry what’s known about the path and mechanism of this mass action disease with a bold strategy that extends service to patients beyond the acute phase of disease to potential prevention. What ACT early reinforces is that the earlier we find patients and the more quickly we can act on disease, the better off patients are. That’s why we also believe that the rapid onset of stabilization and the associated escalation of serum TTR associated with Atruby and the three month separation on CVH and ACM has been demonstrated is a critical aspect of our drugs differentiation.
We’ll continue to publish on this, Atruebis rapid action, and we’ll have more to say about it at this year’s ESC conference. The sum of this ever evolving corpus of clinical research coupled with our efforts in the field should be increasing scientific share of voice which in turn should drive treatment in naive share growth. With treatment in naive populations being the most important battle we believe to win for patients, Matt will have more to say on the specifics of our launch in some moments. As I mentioned in my opening comments, beyond all of the activity around the Truvy, BridgeBio is now poised to become a diversified fully integrated biopharma company with the delivery of up to three novel best of first in class assets in high unmet need areas. Each of these high unmet needs represent the potential for our drugs to serve additional tens of thousands of patients and each individually represents billion plus dollar opportunities.
Turning to the first of these important readouts in autosomal dominant hypocalcemia type one or ADH1. As a reminder, this condition which has no available pharmaceutical therapies to date is one that arises uniformly from gain of function mutations in the calcium sensing receptor and leads to low serum calcium and high urine calcium levels which
Tom Tremarchi, President and Chief Financial Officer, BridgeBio Pharma: in turn drive all of
Neil Kumar, CEO, BridgeBio Pharma: the downstream morbidity associated with this condition. BridgeBio is developing in its Phase III a negative allosteric modulator of the calcium sensing receptor with the goal to show statistically significant normalization of urinary and serum calcium levels as compared to current standard of care. Given the lack of available pharmaceutical therapy or really anything reasonable for these patients, our base case expectation for the trial is simply to deliver statistically significant normalization as compared to standard of care with a safe, easy to take oral drug. The upside expectation, is certainly consistent with both the biology and what we’ve seen in the clinic to date, would be response rate at fifty percent or greater for the patients that we serve. That would be a truly disruptive result.
And who are these patients? How many are there? As with many conditions, a lack of pharmaceutical therapy means that this is a poorly characterized and under diagnosed condition. Today, we believe that there are some three thousand diagnosed patients in The U. S.
Alone, but a recent paper we have released and that’s consistent with observations others have made in large genetic databases indicates that the genetic prevalence is up to twelve thousand patients in The U. S. Alone. The good news here is that we know where to look to find these patients. As we’ve discussed before, sequencing efforts in the nonsurgical hyperparathyroidism space have consistently identified missing ADH1 patients to the tune of twenty percent to twenty five percent.
Further, our experience in TTR where the overall marketplace was also about one fifth diagnosed suggests tactics around education and awareness that we believe are applicable to this launch. The results of this Phase three are anticipated this fall. Importantly, and by the way, this is the case for all of our three late stage medicines, there is substantial promise in follow on indications for Calyret, specifically in this case in hypoparathyroidism. We plan to present an ASBMR compelling data suggesting the promise of Incalorate in chronic hypoparathyroidism. In a cohort of 10 patients, Incalorate normalized urine and serum calcium levels in eighty percent of patients within five days of dosing.
Importantly, this drug brings differentiated promise to the HP community across at least three potential dimensions. First, it’s oral. Second, it potentially normalizes urine calcium, the cause of downstream kidney conditions. And third, it might avoid potential downstream bone associated resorption issues that could require bisphosphonates. Turning now to Limb girdle muscular dystrophy type 2i.
This is the second of our first in class products addressed to a deleterious condition that has no available pharmaceutical therapies. Here again we focused at the intersection of being both safe and highly efficacious employing again a small molecule approach to target this well described condition at its source. This condition uniformly arises from loss of function mutations in an end up called FKRP, salient HP opportunity for Intalarate based on data published and the time value of money. In summary, BridgeBio stands at the doorstep of transforming itself from a company that is predominantly defined by one asset to a company that is serving a multiplicity of important genetic disease markets and with the capabilities in place across its ecosystem to do even more.
Matt Houghton, Chief Commercial Officer, BridgeBio Pharma: Thanks, Neil. I’m pleased to report that Atruby has achieved exceptional performance in the 2025, generating $71,500,000 in net product revenue, representing 100% growth over quarter one, essentially a doubling of net product revenue. The launch of Atruby has accelerated with new patient adds now at around 120 patients per week versus 100 patients per week previously. The uptick has been driven by momentum in treatment naive patients. This strong launch trajectory is driven by more patients starting therapy along with an increasing number of prescribers choosing Intruevi for their patients.
We are operating in a large and fast growing market. The ATTR Centimeters category is expanding rapidly and is expected to reach 15,000,000,000 to $20,000,000,000 at peak. This strong tailwind provides a significant runway for continued growth and reinforces our conviction in Atruvio becoming a category defining therapy. In addition to the significant unmet need in ATTR Centimeters and the compelling value proposition of Atruvio versus our competitors, our clinical data continues to demonstrate Atruvio’s remarkable efficacy. As Neil outlined, we are continuing to generate evidence reinforcing Atruvio’s position as standard of care for ATTR Centimeters patients, especially in the treatment naive setting.
Let me touch on a few key highlights underlying our commercial performance in the second quarter. Atruvi has a strong and expanding prescriber base. COEs and community HCPs continue to prescribe Atruvi at steady rates with new prescribers initiating therapy each week. Those who have written in the past continue to do so, and new adopters continue to expand. Atruby has strong momentum with new starts, capturing share from patients initiating ATTR Centimeters therapy for the first time and shows strong momentum against peak market share expectations of 30% to 40%.
This is leading to increased demonstrated demand across segments. Sale rates remain robust, well above industry averages, with the TrueView’s white glove patient support programs pulling through the increased prescriptions. Further, days of inventory on hand declined from Q1 to Q2, consistent with increasing familiarity and comfort among specialty pharmacies and distributors with our just in time supply model. So why are new prescribers writing and why do current prescribers write more Entruby? The number one reason is differentiated efficacy.
Entruby stands out as the only medication with near complete stabilization in the label. Having a near complete stabilizer has been a welcome addition to the market versus a partial stabilizer and a partial knockdown. Beyond choosing efficacy as a primary reason to start Atruvi, HCPs are worried about affordability. Atruvio continues to be the least expensive medication in the ATTR Centimeters category with most patients paying $0 out of pocket reinforcing Bridge Bio’s commitment to accessibility. In fact, in Q2, almost ninety percent of all Atruvio patients paid $0 for Atruvio.
Additionally, we have seen that patients on Atruvio tend to stay on Atruvio and refill prescriptions on time each month. This is likely due to two factors. First, our access and support programs. Our generous assistance programs continue to make Atruvi accessible, seamless, and simple for patients and providers. Secondly, favorable IRA policies have significantly improved out of pocket costs for oral medications.
ATTR Centimeters patients are on average on seven to eight other medications with a typical out of pocket for oral drugs being between 0 to $2,000 max annually. This often means that patients add a Trevy for no additional cost as I had already mentioned. To close, I want to note that the success of this launch reflects our ability to effectively translate strong science into real world impact and commercial success. This performance not only reinforces confidence in Intruby’s future, but also gives us conviction in our ability to execute future rare disease launches with similar excellence across BridgeBio’s portfolio. As we’ve discussed, BridgeBio has three additional potential launches coming over 2026 and 2027.
The launch of Atruby has allowed Bridge to build a strong commercial infrastructure. This includes top industry talent, but also the basis for the programs and launch plans that we will use to execute these launches. Each of these launches has peak sales potential of more than $1,000,000,000 in The U. S. Market alone.
We look forward to updating you on our commercial readiness in future calls. Now I’ll turn it over to discuss our corporate strategy and give an update on our pipeline programs. Thank you, Matt,
Tom Tremarchi, President and Chief Financial Officer, BridgeBio Pharma: and good afternoon, everyone. I’ll now discuss our financial results for the 2025. Please note that our commentary on today’s call will focus on GAAP financials unless otherwise indicated. Total revenues were $110,600,000 in Q2 twenty twenty five, consisting of the Tribune net product revenue, royalty revenue, and license and services revenue compared to $2,200,000 for the same period last year. The $108,400,000 increase in total revenues was primarily due to a 71,500,000 increase in net product revenue from our commercial product in Tribune, driven by strong demand across all major prescribers and patient segments.
We also recorded $1,600,000 in royalty revenue from ex U. S. Net sales of Meantra in Europe and Japan. License and services revenue increased by $35,300,000 largely due to the $30,000,000 regulatory milestone recognized under the license agreement with Lyceum upon a pricing approval of Piantra by the National Health Insurance in Japan in May 2025. Total operating costs and expenses for the 2025 were $244,800,000 compared to $177,700,000 in the same period in the prior year.
The $67,100,000 increase in operating costs and expenses is primarily driven by $69,600,000 increase in SG and A expenses, partially offset by a $3,500,000 decline in R and D expenses. This reflects our continued investment in the Intruby brand awareness and ongoing investments in our late stage clinical programs. Included in our total operating costs and expenses was $37,700,000 of stock based compensation expense compared to $21,500,000 in the 2024. We expect operating expenses to remain stable through year end with continued revenue growth driven by Intramute. Turning to our balance sheet.
We ended the second quarter with a strong cash position of $756,900,000 in cash, cash equivalents and marketable securities. This includes proceeds from our strategic monetization of Bianchi European royalties for $300,000,000 which has significantly strengthened our financial flexibility together with our proceeds from Atruby sales. Looking ahead, we expect our cash flow runway to extend through multiple value creating milestones. In closing, our commercial launch of Atribi is accelerating and our pipeline has never been stronger. We look forward to the data rich months ahead with top line results from ADH1 and LGMD2i R9 in the 2025, any contemplated in early twenty twenty six and to continue our mission to serve patients and create lasting value for our stakeholders.
With that, I’ll turn the call back over to Shimai.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Thank you, Neil, Matt and Tom. Operator, please open the line for questions. Thank you.
Conference Operator: Thank you. At this time, I would like to remind everyone in order to ask a question, press star then the number one on your telephone keypad. We’ll go first to Salim Syed at Mizuho.
Salim Syed, Analyst, Mizuho: Hey guys. Thanks for the question and congrats on the quarter. I guess one from us on the one hundred and twenty patient adds. So obviously per week, so obviously that’s faster than the one hundred and nine patient adds if we use the April and February numbers that you guys provided. I’m just curious if you can just break that down a little bit more, what you think is driving that patient add number?
And specifically, if you can, how you would envision that number changing in the third and fourth quarter of this year? And also, Neil, I don’t know if you can comment on this, but I think it’s or Matt, I think it’s one of the more important metrics, if you can provide it, just what percentage of Naive’s coming into the marketplace you think you got in the second quarter? Thank you.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Hey, Salim. Thanks for the question. I’m gonna pass it on to Matt to talk about the first piece and then Neil to comment about the second piece.
Matt Houghton, Chief Commercial Officer, BridgeBio Pharma: So Sure. And thanks for the question. I guess to respond to the the first half of your question, we’re seeing strength in treatment naive starts and continued switch activity. The market itself is expanding driven by increased screening and awareness. We’re seeing that quarter over quarter.
Unique patient starts and prescriber counts are both increasing, and this has resulted in BridgeBio becoming the partner of choice for our health care professionals. In addition, the attribute profile really resonates. Both patients and doctors are drawn to it. Benefits as soon as three months and a fifty percent reduction in hospitalization rates, and that’s across subgroups and across patients switching from other therapies, as Neil mentioned in his opening comments. So I think it’s a combination of excellent data, an ever expanding market, and the best team in the industry.
Neil, if you wanna address the second part.
Neil Kumar, CEO, BridgeBio Pharma: Yeah. It’s hard to tell, Salim, exactly what the MBRF share is just because we don’t precisely know where the knockdown stand in terms of that. But, you know, best guess, it’s somewhere in the 18 to 20% range, and it’s been growing pretty pretty healthily. And just to add to Matt Matt’s point, I mean, I think just from being out in the field, a couple of things are starting to drive, I would say, our commercial momentum. But the first is better and better access.
The the second, and I think, critically, is increasing scientific share of voice. I think that serum PPR paper actually did a lot of work for us this quarter, and we can build on that. The fact that ever increasing amounts of stabilization or, in this case, with every additional MIG per deciliter increase in serum PPR, you’re getting that five percent decrease in mortality. And the fact that that just got confirmed by European group, I think, two days ago, the the Minervini paper came out as well. That that’s starting to become a a really salient feature of both staging patients and deciding which therapy to put them on.
So I think that coupled with the variant data coupled with the, ASM data, that they’ll continue to drive momentum here. We just gotta, you know, continue to educate.
Conference Operator: We’ll move next to Tyler Van Buren at TD Cowen.
Salim Syed, Analyst, Mizuho: Hey, guys. Thanks and congratulations on the progress. So last quarter, you all noted the lower than expected utilization of the twenty eight day free trial and the patient assistance programs, while gross to net modestly boosted net revenue per patient. So could you discuss those kind of three components and how the trends evolved in the second quarter compared to the first quarter? And how you expect them to trend moving forward as we head into the second half of the year?
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Hey, Tyler. Thanks for the question. We did indeed see normalization on all of those three fronts, the twenty eight day free trial, the path utilization and the gross to net. But let me turn it over to Neil to give more commentary on on what we saw and what we expect to see going forward.
Neil Kumar, CEO, BridgeBio Pharma: Yeah. I don’t have much to add. As as Jim had said, we did see normalization there. They you know, maybe I’ll talk a little bit about why this is so important to us, obviously, with the variant data, the highest risk reduction shown in the v one twenty two population and the broad variant population, and we’ll we’ll have another publication out on that in in the coming months coupled with statistical significance, is the first we’ve we’ve seen of that. It’s really important for us to be able to serve the under penetrated populations here with ATTR cardiomyopathy, and these programs are a really important feature of that.
So maybe less important than the COEs, which is probably where we had, you know, initial momentum and much more important as we drive out into the community and drive out into communities that have historically been underserved. And I I you know, I I’m aware of kind of some of the narrative around, oh, man, you guys, you know, look at look at the Alnylam launch. It’s at double the cost. Like, why do you price where you price? Why do you guys have a generous access program and suite, etcetera, etcetera?
Look. I think long term, when you look at any category, I’ve honestly never seen a drug with better point estimates and a lower price, not ultimately do really well in terms of end market share. So we’re in this for the long game. Honestly, these generous access programs where we price the product, the continued education, And I think the price and these access programs will stand us in good stead long term. But, yeah, I think you should expect to see the GTM stay normalized over the over the longer course of time and not go back to what we saw initially.
Conference Operator: We’ll move next to Barron Aman at Piper Sandler.
Tyler Van Buren, Analyst, TD Cowen: Yeah. Hi, guys. Thanks for taking my questions. So it seems, you know, I guess, gross per day in the third quarter accelerated compared to the prior period while you guys faced a new competitor. Can you just maybe talk about community versus academic market share for Atribee?
And then maybe a question on the pipeline. What are your thoughts on ifragatinib’s potential market share in Aecon? And how are you positioning the hypochondroplasia program given the recent preclinical data? Thanks.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Hey, Ben. Thank you for your question. I’m gonna pass on to Matt to talk about what’s driving the acceleration and the launch and specifically in the treatment naive segment, both in the COEs and and in
Matt Houghton, Chief Commercial Officer, BridgeBio Pharma: the community setting. And then I’ll pass on to Justin to talk about the MP program. Yeah. I mean, I think it’s the, you know, the overall data package combined with the unmet need. You know, patients either are not being treated effectively and are looking for something else, and so that’s one patient profile.
There’s also patients who are newly diagnosed and are seeking something that can work very fast and hit all the endpoints that they’re they’re trying to hit. So I think regardless of the type of patients coming in and then that can be even then split into more subgroups. We have variant populations. You have patients with Afib. Everybody’s looking for something that can work quickly and for a long time.
And I think that that is what has gotten us off to such a fast start. And the question is, how do you keep that momentum going? Well, the market itself keeps growing every quarter, and that’s because more and more people now are looking for the disease and finding it. So more patients sort of show up even without us doing anything in that regard. But then when they do show up and they find the information that we have, whether it’s online or, you know, from their physician themselves, I think then they’re impressed and wanna want to try a Truvy.
Neil Kumar, CEO, BridgeBio Pharma: And maybe just to build on that and and addressing this specifically to your question. It’s still a majority in the COE or COE capitated practices. Recall that 65% of cardiovascular practices are capitated or JV in some way with a major provider in their space. But we are seeing a pickup in the community, and I think that has to do with, a lot of the awareness stuff that that we and others, are doing. So it’s still a majority in in COE or COE capitated practices, but I expect it’ll continue to disperse over time.
I don’t know. Justin or Lindsay?
Justin To, Program Lead, BridgeBio Pharma: Yeah. And for Gratniv, you know, just as a reminder, when we started this program, we have two key criteria. Right? The first was to have a daily oral treatment option for families who are tired of injections. And the second is to have deeper levels of efficacy by not only taking the MAPK pathway, but also stat one.
And our best in class AHP data and proportionality data from our phase two validated our hypothesis and most importantly with the convenience factor of a daily oral. Now what we’ve consistently done market research that shows an oral with similar efficacy as CMPs would take about 60% of the market in a three way market. Why? Because clinicians and families all view an oral as better than either a daily or weekly injectable. And this market research has been done by others across indications as well as back to that up.
Now we know BioMarin shared some data yesterday on its long acting CMP, which doesn’t change our expectations here. You know, we actually know from their existing phase two data that efficacy on HV and CGMP at the extent plateau above their go ahead commercial dose. So program that achieves higher levels of CMP here won’t really matter. And if anything, it makes it even more important to have a therapy that impacts STAT1 since it looks like it affects the MAPK or max STAT here. Now on hypochondriplasia, we’re really excited about our recent data that we just published in the Journal of Mineral and Bone Research that shows infogratinib has low single digit in vitro potency against the most common hypochondriacplasia mutations and similar efficacy across hypochondriacplasia mouse models as it did compared to achondroplasia mouse models.
So given that, we expect similar best in class efficacy profile in our achontroplasia program as well. So more to come there.
Conference Operator: We’ll take our next question from Cory Kasimov at Evercore.
Salim Syed, Analyst, Mizuho: Good afternoon, guys. Question for you on INCALIORET. I’m curious kind of what your market research is suggesting would be considered a meaningful win in the upcoming Phase III CALIBRATE trial. Thank you.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Hey, Corey. Thanks for the question. I’m gonna pass it on to Anant who leads the program to talk about it.
Anand Sreedhar, Program Lead, BridgeBio Pharma: Yeah. Thanks, Corey. For for this program and ADH one in particular, we we see any successful study as a win, really a home run for this community. As we’ve discussed in the past and as the investor community is familiar, the available conventional therapy or standard of care to our knowledge offers pretty meager benefit on the composite endpoint which we are evaluating in our phase three which is concomitant normalization of both blood and urine calcium which are both important biomarkers and serum biochemistries for the condition. So what we see as as a step change for this community is really we can see a majority of patients achieving those criteria on INCALARA.
We see as both clinically meaningful and statistically significant likely statistically significant benefit achieved for the study and for the patient population. And as a reminder, Corey, if we looked at our phase two cohort at the on these same criteria at the same time point we saw nine out of thirteen around sixty nine percent of our study participants able to achieve that on CALARA. In that same group none or zero percent were able to achieve that criteria of standard of care.
Conference Operator: We’ll take our next question from Manny Faroohar at Leerink Partners.
Tom Tremarchi, President and Chief Financial Officer, BridgeBio Pharma: Hey, guys. Thanks for taking the question, and congrats on
Manny Faroohar, Analyst, Leerink Partners: the quarter. I’ve got a couple, and I’m gonna follow Biren’s lead by starting on a pipeline and going to commercial. For Limb girdle MDQI, can you lay out based perhaps on your table conversations and your interactions with regulators, what the bar is in terms of TFC and biomarker thresholds for potential approval based on the upcoming interim data? And then I have a commercial question to follow-up.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Sure. I’ll pass on to Christine to talk about LGMD two y.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma0: Oh, hi, Manny. So for the top line data that we’re expecting later this fall, we’re gonna look for a few different things in the data that would kind of represent a win for us, both in terms of being clinically meaningful as well as supporting a regulatory approval on the accelerated basis. So first, we’re gonna look for really a robust effect on the biomarkers. The primary endpoint is glycosylated alpha dystroglycan. And what we’re hoping to see there would be consistent with our safety results where we saw an elevation in glycosylated osteoscalcogen, and we think anything kind of 5% or more there would be clinically meaningful.
In addition, we’re gonna look to see a robust reduction in CK of about 40% or more. On the functional endpoint, what would be considered a win there is a trend in one or more of those outcome measurements. It’s important to note that we do not expect both significance at the twelve month time point. The trial wasn’t powered to show it, and the FDA has indicated that it is not a requirement for accelerated approval to see statistical considered the outcome. So, again, just looking for trends in one or more of the functional outcomes.
And then the third thing we’d like to see is a well tolerated safety profile consistent with our phase two results. And I think if we saw all of those, we’d be quite encouraged. Keep in mind, there’s really no available treatments today for this indication, so we’re pretty excited about the opportunity to have a first to market, you know, safe and oral therapy for this indication.
Manny Faroohar, Analyst, Leerink Partners: Great. And hopping over to commercial, I guess a little bit of a composite question. Alnylam talked a lot about on their call about, you know, adding patient volume for Butra in both switch and and and new to market there, a new patient, new to therapy patients. Pfizer talked on pricing, how net price had evolved, and they had been doing more contracting to maintain share. So for each
Tom Tremarchi, President and Chief Financial Officer, BridgeBio Pharma: of these
Manny Faroohar, Analyst, Leerink Partners: competitors, what are you seeing in terms of impact on your own contracting and pricing? And also in terms of volume, are you seeing more impact more impact than more competitive and sort of more active competition on the switch side? Is it primarily competitive competitive intensity for new to new to new to therapy patients? Like, how how should we interpret both of those commentaries from those separate calls and how they inform how we think about the competitive dynamic in what is now a multiplayer market.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Hey, Mani. Thanks for the question. As we noted in our PR, most of our growth came from the treatment naive section and increasing share there where we’ve seen it grow month over month. But let me pass on to Neil to talk in more detail about these things as he’s been out of
Neil Kumar, CEO, BridgeBio Pharma: the field. Yeah. Thanks, Mani. I mean, I guess I’d say, first and foremost, where we’re seeing more pressure from the part of lockdown is in the switch category, obviously, for us. We were a 100% in the switch here prior to you, so, obviously, you’re gonna be under pressure there.
Recall there’s a couple other modes by which they’re getting patients on drug initially. One is combination. And actually, hardly, we’re seeing a lot of combo where where people do reach for the combo. We are seeing people try to use the best stabilizer coupled with the knockdown agents. So we’ve got, you know, we’ve got some combo stuff there and and as does obviously the group plus tab combo.
Then they had the bolus. Right? They had their patients that rolled over. We didn’t we didn’t have that because we we obviously gave away free drugs for life. And then they’ve got what they’ve got in the naive population.
Honestly, we’re not seeing a
Tyler Van Buren, Analyst, TD Cowen: ton
Neil Kumar, CEO, BridgeBio Pharma: of competition there from Alnylam. We’re seeing much more of it from Pfizer. So then turning into what Pfizer’s doing, you know, we’re also not seeing, like, a ton of race to the bottom, GPN contracting type activity in this space. We’ve made it very clear that we stand on this price. You know, we we came in when we came in.
We think it’s the right thing and the ethical thing for, the patient population, but there’s not a whole lot of that backdoor games that we’re playing at all. And we’re not seeing it from a competition either. So outside of the buy and build dynamic associated with the knockdowns, we’re not seeing, a whole lot of, of competition in that vein. The competition is much more so around clinical differentiation and and efficacy.
Anand Sreedhar, Program Lead, BridgeBio Pharma: Did I answer your question?
Manny Faroohar, Analyst, Leerink Partners: Yeah. Thanks. That’s very helpful.
Conference Operator: We’ll move next to Greg Harrison at Scotiabank.
Neil Kumar, CEO, BridgeBio Pharma: Hey. Thanks for taking the question, and congrats on another quarter of success with the launch and uptake of Atruvio. I wanted to ask, where you have identified areas for growth within the Atruvio launch? And separately, what is BridgeBio excited about executing on for the remainder of the year?
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Hey, Greg. Thanks for the question. Maybe I’ll first pass on to Neil and then to Matt to talk about, what we’re excited about in terms of Atruvio and the company. Neil?
Neil Kumar, CEO, BridgeBio Pharma: I think as it pertains to Etruevi, I’m excited about a lot of different things, but, I’d start with the continued clinical and efficacy differentiation that we’ve been working on. I really like the way that we’ve started to port the story from overall, how does this work in the population to specific subpopulations. I think the AFib story or the cardiac arrhythmia story is a really powerful one and certainly opened my eyes, to the power of these types of things, be it a variant story, be it a, you know, cardiac arrhythmic story, be it someone who has renal involvement story, on and on, etcetera, etcetera. So I think that’s that’s thing number one that gets me excited. Thing number two that gets me excited, is the concept of early impact and efficacy.
I think for the longest time, we sort of regarded this as a as kind of a static picture as soon as things were, diagnosed. But, obviously, the earlier we go, the better we do, in terms of all all of the clinical trials. And now we’re running this prevention study, And we have drugs that I think leave patients either unprotected for long periods of time, like you see knockdown go from sixty percent to eighty two percent over the course of twenty two months, or you have prompt resolution of destabilization like you do in the case of acoramidis where you’re almost immediately stabilizing that protein and getting the serum TTR levels up by day 28. So we look forward to continue to elaborate on that early action through publications on a go forward basis. So I I’d say that’s one thing.
Second thing, has to do with access. Obviously, you know, given the fact that the knockdowns were already there in polyneuropathy, given the fact that TAP was already out there, our new to market ads are just coming off. We’re working really hard with local ISPs to make sure that it’s as easy to prescribe a true via as it is anything else. We’re working with new technologies that allow us to work through forms that are provider centric, and we’re working carefully with with Panther and Norsini, to have this sort of white glove service for patients. So, again, I think if that revs up over a long period of time, this is gonna be, a a really nice suite of of of programs support for for patients.
I don’t know, Matt, if you’d add anything.
Matt Houghton, Chief Commercial Officer, BridgeBio Pharma: I’ll just echo maybe one of the comments that you made. You know, making sure that anyone who wants a Truvy can get it is sort of our primary driver right now, and how do we work through any access challenge that might might appear. So the new market edit’s coming off. We’ve been on the market, I guess, a
Neil Kumar, CEO, BridgeBio Pharma: little over seven months now, so it’s right in
Matt Houghton, Chief Commercial Officer, BridgeBio Pharma: that sweet spot when you start to see all of those things happening, and we are seeing that now. That’s going to continue. We keep talking about how we believe in ACP choice, and I think we’ve set ourselves up, as you can see from many programs and different things that we’re doing, try to to make sure that it truly is one of those choices and making sure that the physicians have access to the right therapy for each patient without any unnecessary barriers.
Conference Operator: We’ll go next to Anupam Rama at JPM.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma1: Hey, guys. Thanks so much for taking the question. For Atruby, just thinking about prescribing metrics here, it looks like you grew 300 plus unique docs quarter over quarter. Just wondering what’s resonating with both new prescribers as well as repeat prescribing dynamics and where you’re seeing the most growth in terms of academic versus community centers? So much.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Hey, Anupam. Thank you for the question. I’m gonna pass it on to Mac to talk about it.
Matt Houghton, Chief Commercial Officer, BridgeBio Pharma: Sure. And thanks for the question. First, I think when HCPs try a Truvide and they see how quickly it works, it reinforces the decision that they made to prescribe Atruvib. So one prescription just naturally turns to two and so on. Patients and HCPs talk about their experience, not just with a doctor patient relationship, but also within the patient and physician communities.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma0: And, you know, their experience with
Matt Houghton, Chief Commercial Officer, BridgeBio Pharma: the efficacy of TruVee but also with all of our support programs that we’ve made available, I think it makes a tremendous impact. You mentioned, you know, community versus COEs, but I think the this kind of an impact is equally important in both settings, maybe for different potentially different reasons. And so HCPs who haven’t written, they they write. They they see this. You know, we’re out there with our field teams, and they go ahead and and make that decision.
And then once they’ve written and those who have written, they continue to write more in Truvy while we do our best to make it easy each and every time. So I would expect that you’ll see these numbers continue to grow both in the academic and the community centers every quarter.
Conference Operator: We’ll take our next question from Paul Choi at Goldman Sachs.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma2: Hi, good afternoon and congratulations on all the progress. I want to turn maybe back to the pipeline for a moment and talk about Ncalorate and ADH1 and the potential lateral to hypoparathyroidism. Can you maybe speak to your level of conviction as to how success in ADH1 could translate to hypoparathyroidism? And maybe a little more specifically, how you’re thinking about responder rates might compare to some of the existing or or pipe clinical stage, therapies with regard to use of, supplements or decreasing use of supplements specifically. Thanks for taking the question.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Hey, Paul. Thank you for the question. I’m gonna pass it on to Anant to talk about this.
Anand Sreedhar, Program Lead, BridgeBio Pharma: Sure. Paul, it’s a really good question, especially thinking as ADH one is the most common genetic subset of hypoparas. So there there really is a strong read through that you’re alluding to. A positive study in 80 h one would technically derisk a lot of the further evaluation that we can and then will endeavor to do in chronic hypoparathyroidism broadly. I think the the key aspects that I think would be important on the read through is that, one importantly, the a rapid and durable benefit of blood and urine calcium.
I think if we see that in the ADH one population, it’ll certainly be encouraging as that is a critical unmet need and a and a clinical need for the hypoparathyroidism community. And then the the other is gonna be on the safety aspect. So the broad exposure of the doses we’re evaluating in a d h one will will also be an important derisking signal for the chronic hypoparathyroidism development program. In terms of the the response rates, think I’ll point the community to our presentation of our sentinel study of IncalaRed in chronic hypoparathyroidism, which we intend to present at the American Society of Bone Mineral Research meeting, is taking place next month. In that cohort, we we resolved that within five days of dosing initiation with IncalaRed, eighty percent of study participants were able to normalize both blood and urine calcium concomitantly.
This study did not evaluate whether patients can come off standard of care that will be evaluated in a longer term study. But importantly, this is a key differentiating element which Neil touched on in in the earlier remarks, ENCOLURA could differentiate in this in this patient population with three critical elements. One is oral. Two, it it may have a benefit on urine calcium on on twenty four hour urine urinary calcium excretion to the extent that other therapies have not yet shown to date. And three, it could avoid long term bone resorptive effects that may have been have been seen and may may continue to be seen with, long term PTH replacement therapy.
Conference Operator: And we’ll take our final question today from Andrew Tsai at Jefferies.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma3: Team, congrats on the launch execution. Thanks for taking my question. So I think one of the thematic discussion points is that Atruvio could be differentiated based on a lot of data you’ve generated over the past few months. So operationally speaking, how do you exactly leverage the data to convince payers and doctors to use Atruvio more in the first line setting over the coming years? And can you summarize all the additional data sets that you plan to generate over the next, let’s just say, to twenty four months?
Can we get a glimpse of the real world data on like NT proBNP troponin all the way to hard outcomes data? And then really quickly, can you quantify the inventory changes in Q2 relative to Q1? Thank you.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Sure. Andy, thank you for your questions. I’m gonna pass on to Neil to talk about the Atruvian data, and then Matt and I can talk a little bit about inventory at the end. But let me pass on to Neil to talk about the differentiation.
Neil Kumar, CEO, BridgeBio Pharma: Yeah. Thanks, Andy. I guess your first question was what are the tactics we’re using to educate in and around the data that we have produced? Obviously, they’re the obvious aspects of this at conferences, publications, etcetera. I think our medical affairs team has done a nice job of increasing our scientific share of voice.
And, obviously, I think we have the highest velocity of of publication in this sector so far, so that’s given us an opportunity to share something new with the physicians that that we do see. You know, the
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: sec the second piece of
Neil Kumar, CEO, BridgeBio Pharma: it, honestly, has been conversations. This is a put some fraction of your patients on a Truvy to Matt’s earlier point and, you know, see what the experience is. And then I think we feel very comfortable, obviously, with the two real world evidence studies that have been posted to date out of doctor Mazri’s lab and doctor Moore’s lab that continued outperformance in the real world setting. And we’re doing a lot more of this now on the health economic and real world setting side, just what do hospitalizations look like with one stabilizer versus the next? What do overall expenses look like with various SPs, etcetera, etcetera.
So we so we’re doing a lot of, that type of work, and I think that’s another way that we can allow the data to resonate. A summary of the data, you know, I think of the of the new data that we just put out has to be the variant data, the 59% relative risk reduction with the stat sig, the, AFib data, the the 70% reduction along with the the 43 reduction in in in CVH associated hospitalization. And then, the third, and I think, honestly, the most important, was the connection once again between ever higher levels of stabilization as measured by certain TTR and better outcomes as measured by, mortality. But I think those were the new salient data pieces, to date. And then on a go forward basis, you can expect that we you know, as I mentioned earlier, that we’re gonna publish on all of those fronts plus more.
One thing we’re definitely gonna be looking at is the rapidity of response, because I think that well, now that we’ve got the PK data from the knockdowns, I think that actually is a huge differentiator of the rapidity of response. So you should see a lot more publications coming out on that front. I think the second is the real world experience with these products, both from the standpoint of of biomarkers. I think NT pro, yes. Definitely.
I think serum TTR, yes. Definitely. And then quality of life and hospitalization measures, and then health economic, you know, parameters as well. You know, it’s interesting, you know, if you go over to Europe, like, we there’s there are countries where we’re the only brand. Like, we won the national bid, and there are major hospitals in areas like Germany where Atruvio is is frontline.
And I think we’re we’re we’re sort of looking at those types of very dispassionate, but yet still trying to make a choice between these various datasets analogs and saying what really resonated with them in that data and how do we bring some of those messages over to The US market. So, yeah, I don’t know, Matt or anyone. Anant, if had anything.
Matt Houghton, Chief Commercial Officer, BridgeBio Pharma: No. I can touch on the inventory question, though, if that works. I just wanna make a couple of comments. One, the held inventory is lower in q two versus q one as suppliers get used to our just in time model. And so why?
Well, you can get a Truvy in less than forty eight hours. We talk about that for patients all the time, but it’s not just patients. Our suppliers can also get a Truvy in less than forty eight hours as well. So the sort of old way of doing the supply and demand model, which is, hey. I have to hold multiple weeks of inventory or more because I’m worried about running out or not being able to get some.
I think we’ve we’ve sort of changed the game a bit in that. So now that people realize that that’s true, they don’t have to hold these sort of historical larger levels, and so you’re seeing that, play out in the market now. And I think that’s just due to the confidence that our distributors have in us.
Neil Kumar, CEO, BridgeBio Pharma: Yeah. Thank you.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: And, like, mine said, you know, the days went down because of the accelerating patient demand and and the model being more familiar to our suppliers. So appreciate your question.
Conference Operator: And that concludes our Q and A for today. I will now hand it back to the company.
Chilmai Shukla, Senior Vice President of Strategic Finance, BridgeBio Pharma: Thank you all for joining us on our Q2 earnings call. We look forward to updating you again in our next earnings call. Thank you. Bye.
Conference Operator: And this concludes today’s conference. Thank you for your participation. You may now disconnect.
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