BridgeBio Pharma (BBIO) Q3 2026 Earnings Call: Attruby Revenue Up 134%, Three Launches Ahead

Key Takeaways

• Q3 2026 total revenue rose to $353.2 million from $120.7 million a year earlier, driven by Attruby growth, higher Beyonttra royalties and a one-time $75 million Bayer sales milestone.
• U.S. Attruby net product revenue reached $253.2 million, up approximately 14% quarter over quarter and 134% year over year. Management expects near-term sequential growth of roughly $25 million to $30 million.
• BridgeBio reported a Q3 operating loss of $11.6 million, improving from $145.2 million in Q3 2025. Cash, cash equivalents and marketable securities totaled $1.5 billion at September 30, 2026.
• Three FDA decisions are scheduled within seven months: BBP-418 on November 27, 2026; infigratinib on February 4, 2027; and encaleret on May 8, 2027. All three applications received priority review.
• Management continues to believe the Attruby-Beyonttra franchise can meet or exceed its $4 billion peak-year sales assumption. The company also sees a combined $4 billion peak-year sales opportunity across BBP-418, infigratinib and encaleret.
• BridgeBio expects Q4 operating expenses to rise as launch spending catches up, followed by more modest expense growth and an improving operating line through 2027 and beyond.

Core Financial Data

Business and Operating Performance

Attruby maintains first-line momentum

Attruby remained BridgeBio’s primary growth driver. Management said growth is now predominantly coming from first-line new patient starts, which it views as an important indicator of future market share.

Approximately 2,900 physicians have prescribed Attruby, while more than 60% of potential prescribers have yet to try the drug. BridgeBio plans to broaden outreach beyond high-volume cardiology centers to lower-volume and non-cardiology specialists.

The company highlighted two recent real-world comparisons with tafamidis. A Komodo claims analysis associated acoramidis with a 34% reduction in composite clinical worsening and a 43% reduction in diuretic intensification. An Epic COSMOS analysis of nearly 2,700 matched ATTR-CM patients found an 18% lower risk of a composite including death, hospitalization, new-onset atrial fibrillation and diuretic intensification. Cardiovascular, heart-failure and all-cause hospitalization risks were reported as 25% to 27% lower.

Management also emphasized a potential kidney-protective signal and said further analysis is underway. BridgeBio has dosed the first participant in ASCEND ATTR, a Phase IIIb/IV cardiac imaging study, and nominated BBP-717 as a next-generation monoclonal antibody development candidate, with an IND planned for 2027.

BBP-418 approaches FDA decision

The BBP-418 PDUFA date for LGMD2i/R9 is November 27, 2026, with no advisory committee planned. Management said it remains confident in a traditional full approval, based on its interactions with the FDA.

BridgeBio has identified more than 500 unique U.S. patients through claims, genetic testing and account profiling. Around 70% receive care through the Muscular Dystrophy Association care-center network. The company’s account managers had reached more than 70% of those centers and expected to reach at least 90% by the PDUFA date.

For Europe, BridgeBio plans to submit an MAA in the first half of 2028 using the final 36-month FORTIFY analysis. Management estimates more than 4,000 LGMD2i/R9 patients in Europe, where regulators have requested the longer-term dataset.

Infigratinib receives priority review

The FDA set a February 4, 2027 PDUFA date for infigratinib in achondroplasia. The treatment would be the first oral option for the condition if approved. BridgeBio has also submitted an MAA to the EMA and anticipates a potential EU decision in the second half of 2027.

The company said its U.S. commercial field team is fully staffed. Additional 52-week data presented during the quarter showed a 38% lower rate of ear infections versus placebo, while sleep-apnea measures remained stable compared with a 49% increase on placebo.

Encaleret expands beyond ADH1

Encaleret’s PDUFA date for ADH1 is May 8, 2027, with no advisory committee planned. BridgeBio has identified more than 600 genetically confirmed U.S. patients, up from approximately 500 in the prior quarter. An EMA application is also under review, with a potential European decision in the second half of 2027.

BridgeBio also dosed the first participant in RECLAIM-HP, a global Phase III study in chronic hypoparathyroidism. The study is expected to enroll approximately 160 patients and assess simultaneous normalization of blood and urine calcium at week 24. Management estimates roughly 200,000 chronic hypoparathyroidism patients across the U.S. and Europe, compared with about 25,000 prevalent ADH1 patients in those regions.

Management Guidance

• Management expects Attruby’s near-term sequential revenue increase to remain around $25 million to $30 million, with potential to increase over time.
• Q4 2026 operating expenses are expected to catch up after favorable expense timing in Q3. BridgeBio then expects more modest, steady expense growth and improvement in the operating line during 2027 and beyond.
• The CFO expects BridgeBio to average an operating loss of approximately $90 million to $100 million per quarter in 2026, compared with about $130 million per quarter in 2025.
• Management said the current $1.5 billion cash position is sufficient to support Attruby investment, three planned launches and ongoing pipeline development.
• Top-line results from the RECLAIM-HP Phase III trial are anticipated within 15 months, according to management.

Risks and Points to Watch

• The three planned launches remain subject to FDA approval on their respective PDUFA dates.
• Attruby’s growth strategy depends partly on expanding prescribing among the more than 60% of potential physicians who have not yet used the product.
• A major payer continues to prefer VYNDAMAX following a policy change made in 2025. BridgeBio said Attruby appeal approval rates exceed 90%, but payer access remains an important launch variable.
• Proposed reimbursement changes could potentially benefit Attruby by leveling the competitive environment, but management stressed that the final legislation and its effects remain uncertain.
• A competitor citizen petition raised questions about infigratinib. BridgeBio said it does not expect an impact on the review timeline or label, but the FDA’s decision remains pending.
• European filing for BBP-418 will require the 36-month FORTIFY dataset, delaying the planned MAA submission until the first half of 2028.

Analyst Q&A Highlights

Attruby growth: Management reaffirmed near-term sequential revenue growth of approximately $25 million to $30 million. It cited first-line adoption, new prescribers, strong persistence and compliance, and dissemination of real-world evidence as the main growth drivers.

Launch funding: The company said its $1.5 billion cash balance covers anticipated operating needs. Management expects increasing Attruby operating leverage to help fund the three planned launches.

Capital allocation: BridgeBio identified three priorities for excess capital: retaining cash for optionality, expanding the pipeline through transactions or related-company integration, and repurchasing shares. Operating investment remains the first priority.

BBP-418 launch metrics: The company expects to provide more quantitative launch indicators around its Q4 earnings call in early 2027. It intends to target the more than 500 genetically identified U.S. patients over the course of the launch.

Chronic hypoparathyroidism opportunity: Management identified patients with persistent hypercalciuria, low bone mineral density and injection-site reactions to existing therapies as groups showing strong interest in RECLAIM-HP. The study uses a more stringent endpoint requiring normalization of both blood and urine calcium.

Full Earnings Call Transcript

Complete Earnings Call Transcript

Management Remarks

Operator

Hello, everyone. Thank you for joining us, and welcome to BridgeBio Third Quarter 2026 Earnings Call. [Operator Instructions]

I will now hand the conference over to Chinmay Shukla, Chief Business Officer. Chinmay, please go ahead.

Chinmay Shukla

Good afternoon, everyone, and thank you for joining BridgeBio Pharma's third quarter 2026 earnings call. I am Chinmay Shukla, Chief Business Officer. With me today are Neil Kumar, our CEO; Matt Outen, our Chief Commercial Officer; and Tom Trimarchi, our President and Chief Financial Officer.

During today's call, we will cover another quarter of consistent growth for Attruby, along with new real-world evidence that continues to differentiate acoramidis from tafamidis on outcomes that matter to patients, physicians and payers. We will then turn to BBB-418 where we are weeks away from potential launch. Finally, we will discuss the pipeline where the PDUFA date for infigratinib is now set for February 4 with priority review, and the PDUFA date for encaleret is May 8 with priority review. We're also particularly excited to discuss updates from our chronic hypoparathyroidism program, where we dosed the first patient in our Phase III trial. Following our prepared remarks, we will open the call for questions. For the Q&A session, we will be joined by the leaders of our encaleret BBP-418 and infigratinib programs.

With that, I'll turn it over to Neil.

Neil Kumar

Thanks, Chinmay, and thanks, everyone, for joining today. As always, these calls are where we communicate relevant aspects of our business to investors, and so we welcome your questions and feedback. I'm excited to report updates from our TTR franchise and across the portfolio today as we enter into a new phase in our TTR launch, paired with three launches ahead of us in the next 7 months. I will talk about that and further contextualize the numbers from this quarter in a moment. Before I do, I want to acknowledge that we are now annualizing to over $1 billion in the U.S. market and well over that globally with our Attruby-Beyonttra franchise. This puts us ahead of the analogs we studied and used to guide our performance. This is coupled with an ever evening playing field in the United States, a consequence of Attruby's growing size, it's increasing evidentiary base and the changing reimbursement environment, which we believe sets us up well in the quarters and years to come.

It's interesting to remark that Attruby is the leading brand in Europe where rules around reimbursement and marketing are tighter. For today, we feel good about our continued revenue growth. We will have to wait for Pfizer's numbers later to accurately understand our share trajectory, but numbers from our other competitor this morning show that we are solidly in second place with respect to new patient starts and overwhelmingly sell in the critical first-line setting. Obviously, we aspire for more and feel we have set a base to do so in the quarters and years to come.

Before I comment further on our pipeline and revenue, I wanted to provide some brief context on how we think about the information we're sharing with you quarter-to-quarter. Obviously, the goal of these calls is to reduce information asymmetry between investors and managers so that the firm can be fairly valued over time. What this means is that we should be providing you information over time that informs your valuation model of the company. Although we meet in the context of these calls every quarter, it's a natural question to ask whether or not these updates provide salient information that allow you to revalue the firm. For instance, if a quarterly sampling is done on a system that only moves materially over the course of years, then all I'm providing you is noise. On the other hand, a quarterly sampling is inadequate for systems where salient differences are occurring on a weekly basis. Keeping that thought in mind, quarterly updates as associated with our R&D activities are generally too frequent. And we try to keep investors abreast of key R&D advances when they occur within our portfolio, generally through press releases, conference presentations and vitally publications.

On today's call, I'll be summarizing a number of R&D items that we've already updated you on through these channels. However, in the commercial setting, quarterly updates contain real information content. In fact, our own modeling of some 1,040 launches suggests that the first quantum of time that contains predictive information for sales is the 4-week rolling average. So from the perspective of frequency, quarterly updates on revenue contain real information, which I think we all know. But there's a second aspect of the information being provided, which is what is the magnitude of change required to drive a change in your valuation of the firm or critically your peak year sales assumption, but simply, how big do the changes need to be in order for the number to be a signal and not a reporting of noise? We asked this question as well of the 1,040 launches and more importantly, drilled into the first couple of years of launch to understand what the quarter-to-quarter variance in revenue growth looked like for brands that ended up doing over $3 billion in sales.

Interestingly, there was on average a 20% variance quarter-to-quarter that did not meaningfully impact projected peak year sales. If you go and look at brands like Eliquis, Tagrisso and others that we feel are of the size, we believe the Attruby-Beyonttra franchise will be, you can see a very meaningful quarter-to-quarter change, but ultimately, a trajectory that obviously supported multibillion-dollar sales. So adding this lens, in addition to our current quarter's data, we continue to believe that Attruby is tracking to meet or beat our $4 billion peak year sales assumption. And we believe that we have $4 billion in peak year sales across the other three brands that we'll discuss in today's call as well.

So let me now delve into Attruby's performance this quarter. We observed continued commercial momentum this quarter. Attruby U.S. net product revenue was $253.2 million, an increase of approximately 14% quarter-on-quarter and approximately 134% year-over-year. Our growth now is predominantly coming from first-line new starts, which as we've discussed is our key focal area and predicts future total share in the marketplace. As I mentioned, we can't comment specifically on NBRx share on this call because we have not seen fires in quarterly numbers yet. But as we look over the marketplace as a whole, we continue to see strong performance amongst the approximately 2,900 physicians that have tried Attruby, mostly cardiologists at either academic medical centers or at high-volume heart failure practices.

Where one big slice of the opportunity arises that is remaining is the over 60% of prescribers who have yet to try Attruby, and who are primarily lower volume often non-cardiology specialists. Some of our competitors who are better resourced that begin reaching out to this longer tail of physicians, and you should expect us to pursue that opportunity as well as we build on our differentiated product profile and seek opportunities to educate a broader diaspora of prescribers.

I'd like to take a few minutes on the tailwinds that define our differentiation so that you can share our excitement. I'll begin with the Attruby's growing body of real-world evidence and then discuss the increasingly exciting kitty protective signal that we continue to elaborate on, and then finally, the readout from cardio transform cementing stabilizers as the first-line therapeutic backbone for ATTR cardiomyopathy. First, real-world evidence. I've said before that in the cardiovascular market, where double-blind head-to-head are immediately possible, real-world evidence set the bedrock of ultimate commercial performance. Since we last spoke, that bedrock has gotten considerably firmer with two large real-world comparisons of acoramidis against tafamidis, drawn from two different data types pointing the same way and further reinforcing other real world evidence studies that were published earlier this year. The first of these new studies was published in September in cardiology and therapy. The first peer-reviewed contemporary real-world comparative evidence study of TTR stabilizers. In Komodo U.S. claims data, acoramidis significantly reduced the risk of early clinical worsening versus tafamidis with a 34% reduction in composite clinical worsening and a 43% reduction in diuretic intensification.

Separation and clinical outcomes emerged within weeks of treatment initiation and increased over time. The second came at HFSA just 2 weeks ago, where Dr. David Lanfear of Henry Ford presented an independent propensity score matched analysis of nearly 2,700 ATTR cardiomyopathy patients from Epic COSMOS, the largest electronic health record database in the United States. This is a contemporary cohort patients from 2025, and it is the first EHR-based comparison of the two stabilizers. Acoramidis was associated with an 18% lower risk of the composite of death, all-cause hospitalization, new onset Afib and diuretic intensification versus tafamidis with a hazard ratio of 0.82 and a p-value below 0.01.

On the outcomes that matter most to patients and to payers, the effect was larger, a 27% lower risk of cardiovascular hospitalization, a 27% lower risk of heart failure hospitalization and a 25% lower risk of all-cause hospitalization, all with p-values less than 0.001. The curve separated within the first month and the result held across unadjusted matched and biomarker adjusted analyses. Hospitalization isn't a soft endpoint. It is the disease.

Second, the kidney. We've shared much of the detail before on what we've seen today, so I'll be brief here. The kidney protective effect associated with acoramidis does many things for us. It helps explain acoramidis' early onset of action, the early eGFR dip and the early separation and cumulative cardiovascular outcomes both occur about within a month. And our hypothesis that acoramidis effectively rests the kidney to protect longer-term function as evidenced by the sustained reduction in eGFR slope decline over 30 months. It strengthens the evidence of long-term benefit. The association of the eGFR dip with improved clinical outcomes shows this effect is good for the patients we serve, including those with renal complications through a mechanism that appears to be similar to SGLT2 inhibitors. And it generates a new hypothesis for future indications, namely whether acoramidis can benefit patients living with high proteinuric conditions. We are also beginning to see clues that kidney dysfunction may help indicate patients before ATTR cardiomyopathy is recognized clinically. Our statistical genetics team is engaged in further analysis, and we look forward to sharing interesting findings from that research in the future.

Finally, there were three key takeaways from ESC, where the full cardio transform results were presented at the end of August. One that adding a silencer on top of background stabilization does not improve outcomes. This effectively closes the door on combination therapy as the end state of this market. Two, knockdowns are interchangeable. Placebo-adjusted depth of serum TTR reduction was approximately the same between both observed knockdowns and there was no differentiated impact of knockdown. Recall that both agents take many months to reach maximum knockdown, which is reflected in how long it takes for their event curves to separate from placebo in contrast to the early separation we observed with acoramidis, which is as early as the first month. Three, there is plenty of room to improve on tafamidis. Within the placebo arm of HELIOS-B, for instance, patients on background tafamidis showed a relative risk reduction of just 21.7% and on all-cause death and recurrent cardiovascular events compared to those on no therapy at all. But simply, this is a stabilizer first market, the bar set by tafamidis and acoramidis is the first and only near complete stabilizer. ESC was also where we presented our own data and provided evidence of potential reversal of cardiac structural disease progression in ATTR cardiomyopathy. Serial -- CMR imaging from the ATTRibute-CM study and its open-label extension showed clinically meaningful improvement in left ventricular systolic function in 54% of acoramidis-treated participants versus 20% of placebo-treated participants at month 30. And in 53% of continuous acoramidis participants at month 42 in a completer analysis. Participants treated with acoramidis gained an unprecedented 65 additional days alive and out of the hospital by month 6. And month 54 data published simultaneously in the European Journal of heart failure showed a more than twofold mortality difference favoring continuous acoramidis within the V122I subgroup.

Building on that, we have dosed the first participant in ASCEND ATTR, a Phase IIIb/IV study of cardiac structure, function and amyloid burden by cardiac MRI and echo over 36 months. And because we think the question of what comes after stabilization is still worth asking we nominated BBP 717, a next-generation monoclonal antibody depleter for ATTR cardiomyopathy as a development candidate this quarter with an IND planned for 2027.

Now to the three programs in regulatory review, beginning with BBP-418 for LGMD2i, where the PDUFA date is November 27, roughly 4 weeks from today. There is no advisory committee planned. This is in line to be the next approval in our portfolio and if approved, the first therapy for any limb-girdle muscular dystrophy.

In the U.S., we have already identified more than 500 unique LGMD2i patients through claims, genetic testing and account profiling. Globally, Europe has the highest prevalence of LGMD2i with more than 4,000 patients due to a founder mutation most often seen in people of North European ancestry. There, we have had multiple positive high collaborative interactions with national health authorities and we intend to submit an MAA to the EMA in the first half of 2028. That submission will be based on the FORTIFY month 36 final analysis with top line results expected in late '27 or early '28.

On the data, I'll remind everyone that 45 every primary and secondary endpoint at the 12-month interim with treated individuals improving while placebo declined across every key measure. At World Muscle Society earlier this month, we extended that story to the heart, which is among these patients' greatest concerns. Among participants with elevated high-sensitivity troponin I at baseline, 100% on BBP-418 returned to normal range by month 12 versus 40% on placebo. And 54% of treated participants had stable or improved ejection fraction versus 25% on placebo.

Separately, the laboratory of Dr. John Vissing in Denmark, one of the foremost KOLs in the field showed that BBP-418 increased glycosylated alpha-dystroglycan above levels seen in asymptomatic FKRP carriers, i.e., people who carry a single copy of the mutation and don't get the disease.

People sometimes forget that most therapies in progressive neuromuscular disease aimed to slow decline. This one restores the underlying biology to unaffected levels and patients get better. That is the type of transformative effect we seek to have with disease-modifying treatments. In order to have that effect, of course, we will need to deliver the drug to patients.

So let me say a few words about our launch readiness. About 70% of LGMD2i patients receive care through the MDA care center network. And since entering the field in August, our neuromuscular account managers have reached more than 70% of MDA centers and are expected to reach at least 90% by PDUFA. To find the patients who are still misclassified within the broader LGMD population, we launched type hype, a patient-facing campaign that encourages people with suspected LGMD to ask their doctor about genetic testing. The drug is manufactured and ready to go in channel. We are poised to deliver for a patient community that is waited far too long.

Turning next to infigratinib for achondroplasia. We're heartened that the FDA accepted our NDA and granted priority review with a remarkable PDUFA date of February 4, 2027, meaning if all goes well, we will launch the only oral product for achondroplasia less than 12 months since the entry of the latest commercial injectable. Infigratinib holds breakthrough therapy, fast track and rare pediatric disease designations and is the only therapeutic option in development for achondroplasia with BTD. We have also submitted an MAA to the EMA and anticipate EU approval in the second half of 2027. Recall that PROPEL 3 is the only achondroplasia Phase III study published the New England Journal of Medicine and remains the only program with placebo-controlled efficacy beyond annualized high velocity of 52 weeks, including statistically significant improvements on both proportionality and arm span.

At ESPE in September, we presented additional benefits beyond height. Over 52 weeks, children on oral infi had a 38% lower rate of ear infections than placebo, and their sleep apnea measures stayed stable compared to a 49% increase on placebo. We are also the only program in this space with in obstructive sleep apnea and otitis media data set. On the commercial side, our U.S. field team for oral infi is fully staffed with deep experience across growth disorders, including achondroplasia, rare genetic conditions and competitive launches.

Finally, encaleret for ADH1. The NDA is under priority review with the PDUFA target action date of May 8, 2027, with no advisory committee planned, and our MAA has been submitted to the EMA with potential EU approval in the second half of 2027. Encaleret would be the first approved therapy specifically indicated for ADH1 in both the United States and Europe. The U.S. field team dedicated to encaleret has been trained and deployed and we have identified greater than 600 genetically confirmed patients, up from approximately 500 last quarter. Since we last spoke, we have seen three further pieces of the story told by our Phase III in study in ADH1 calibrate. First, kidney at ASN Kidney Week, we have shown that in addition to normalizing blood and urine calcium, encaleret was associated with a significant increase in kidney function at week 24 compared with conventional therapy. With an EGFR change of plus 11% versus plus 3 ml per minute per 1.73 meters squared. Given that long-term complications of conventional therapy are nephrocalcinosis, kidney stones and chronic kidney disease, that is not an incidental finding.

Second, in the bone, at ASBMR, encaleret demonstrated bone turnover by restoring the bone's own PTH production, which says that the drug is addressing the underlying biology of the disease rather than simply influencing symptoms. Third, how patients feel 100% of participants on encaleret reported an improvement in at least 188 symptom versus 46% on standard of care with the largest deltas in fatigue, muscle spasms, tingling and brain fog, the things with this condition -- the things that people will this condition live with every day even on preventional therapy.

Our CALIBRATE-PEDS trial, our registrational Phase II/III study in pediatric ADH1 has completed enrollment of the first 4 -- of the first of 4 cohorts adolescence 12 to 17. And as I have said last quarter, ADH1 approval is the beginning of encaleret's potential, not the end. In October, we dosed the first participant in reclaim HP, our global registrational Phase III in chronic hypoparathyroidism, condition affecting approximately 200,000 patients in the U.S. and EU and a substantial expansion of the intolerant opportunity beyond ADH1. The study will enroll approximately 160 individuals with the primary end point a proportion of participants achieving both blood and urine calcium normalization at week 24. I won't repeat the full mechanistic argument from last quarter, but I'd simply reiterate that endpoints are reliable. The drug's onset is rapid, and in our proof of concept, 80% of postsurgical patients normalize both blood and urine calcium within 5 days. We continue to see this as a relatively quick trial with a high probability of technical success, and we anticipate top line results in the next 15 months.

So put simply, we are a company with three launches in the next 7 months. I'm not aware of many companies our size that have been handed that type of opportunity, and we don't intend to waste it. From the standpoint of operations, that means both focused execution against these three launches and taking advantage of our Silicon Valley routes to continue to pioneer our commercial model fit for today's technologies where an AI is redefining how physicians are having conversations with themselves, patients with themselves and physicians with their patients. Those conversations are being buttressed by new devices and technologies that allow us to measure ever more signals of health from functional endpoints all the way back to genetics. We anticipate elaborating on how we intend to operate within this modern commercial concept on future calls. But needless to say, the parallel introduction of a genome that cost $250, coupled with AI's ability to identify and educate patients and physicians opens up new avenues that we are aggressively exploring.

Finally, our strategic and financial posture continues to focus on taking advantage of our disconnect from intrinsic value through our previously discussed share buyback program and judicious use of resources to capture the full opportunity from each of our launches.

With that, I'll turn it over to Matt.

Matthew Outten

Thanks, Neil. This is an exciting and pivotal moment for BridgeBio. Attruby is continuing its growth trajectory. The PDUFA date for infigratinib has been assigned as February 4, we have a PDUFA date for encaleret for ADH1 of May 8, and of course, the imminent approval and launch of BBP-418, which is just a few weeks away. This represents three unique NDAs on all assigned priority review by the FDA. I'll take you through updates for each of our programs, starting with Attruby. Attruby delivered another strong quarter. Net product revenue was $253 million, up 134% from Q3 of last year driven by continued share gains in the first line. The reason is the evidence and it has become impossible to ignore. Across real-world data sets, the pattern is consistent, patients on Attruby are doing better than patients on tafamidis. At HFSA, we presented an independent analysis of 2,684 propensity score matched patients with ATTR-CM from Epic COSMOS. Compared with tafamidis, acromidis was associated with an 18% lower risk of death hospitalization, new onset of atrial fibrillation or diuretic intensification and 25% to 27% lower risk of all-cause cardiovascular and heart failure hospitalization. This builds on the Komodo analysis published in September, different data sets, comparative contemporary populations same answer. This is also exactly what you would expect. In our Phase III trial, Attruby separated from placebo in just 3 months was a 50% reduction in cardiovascular hospitalization.

At ESC, we show the survival benefit holds through 54 months including in variant disease, V142i, also known as V122i. These results are what we have come to expect from the only near-complete stabilizer and is why we believe Attruby is a stabilizer of choice. We are also investing in finding patients. In recognition of World and Lotus Day, we launched a nationwide ATTR-CM education effort with community partners because too many patients remain undiagnosed.

For the rest of my time, I want to focus on the three upcoming launches in order of PDUFA date. First, I'll start with BBP-418. I'm really excited that we're mere weeks away from potentially launching the first and only treatment in LGMD2i/R9. This represents a huge milestone for patients. In October, at the World Muscle Society Congress, we presented additional FORTIFY data, including exploratory cardiac data, adding to an already strong profile Cardiac involvement is a top concern for patients and HCPs. So this is a meaningful addition to the body of evidence on the impact of BBP-418 in LGMD2i/R9. Our field teams are hired and deployed with field medical engaging centers since May and our commercial team in the field since August. Ahead of approval, their work is focused on readiness on the ground, including disease state education and genetic testing awareness. Through a combination of claims, genetic testing and account profiling, we have identified more than 500 patients living with LGMD2i/R9 in the U.S. and about 70% of them receive care through the MDA care center network. Our account managers have already introduced themselves to more than 70% of those centers and expect to reach more than 90% by launch. On awareness around LGMD awareness Day in September, we launched Type Hype, a patient-facing awareness campaign, encouraging people with suspected LGMD to talk with their doctor about genetic testing because many people living with LGMD2i/R9 remain undiagnosed. Patient support programs modeled on our prior launches will be in place at launch.

Turning to Europe based on multiple positive, highly collaborative interactions with national health authorities in the EU, we intend to submit a marketing authorization application to the EMA in the first half of 2028 based on the fortified file analysis at the 36-month time point. Due to a founder mutation most often found in people of Northern European ancestry, Europe represents the highest density of LGMD2i/R9 prevalence globally with up to 4,500 patients. All launch work streams are on schedule, and we are ready for the FDA's decision in November and the opportunity to bring BBP-418 to the patients who need it. Second, I'd like to discuss infigratinib in achondroplasia, which is the biggest update since last quarter. On October 6, the FDA accepted our NDA with priority review and set a PDUFA date of February 4, 2027, ahead of the mid-2027 launch timing we described last quarter. Our field team is hired, trained and in the field, profiling accounts and providing disease state education, the team is sized to compete effectively and to capture the market opportunity. They bring deep experience in rare disease, achondroplasia and pediatric endocrinology.

Our sales team is building on a foundation that has been in place for some time, our field medical team has been meeting centers of excellence and key opinion leaders for 14 months, and our advocacy team has been engaged with the achondroplasia community for over 7 years. We continue to hear from HCPs and families that the anticipation of infigratinib continues to build. We're ready and excited for the February 4 PDUFA date and to bring the first and only oral option to families living with achondroplasia. Third, let me turn to encaleret in ADH1, which has a PDUFA date of May 8, 2027. Of note, encaleret also received priority review and caliber, it would be the first and only therapy specifically indicated for ADH1. The team we described last quarter is now on board and deployed in the field with nearly 90% bringing rare disease experience to the team. We have also added field medical and field reimbursement roles this quarter. Most of our efforts have gone into finding patients. ADH1 is genetically distinct, but it presents like hypoparathyroidism and most people living with it are carried under that diagnosis for years before anyone thinks to test for the mutation. So the work ahead of launch is disease state education, including diagnosis.

Our primary call points are endocrinologists and nephrologists, and this quarter, we expanded sponsored genetic testing utilization and deepen the disease education across both specialties. The effect is that patients are being identified who would be eligible for treatment upon approval. We have now identified more than 600 genetically confirmed patients, up from approximately 500 last quarter, and that number continues to grow. Looking beyond the U.S., we have also submitted MAA to the EMA for both infigratinib and encaleret, positioning both for potential approvals in Europe in the second half of 2027.

In summary, while we continue to grow with Attruby, we also have three additional programs that are on track to launch at their respective PDUFA dates.

With that, I'll turn the call over to Tom.

Thomas Trimarchi

Thank you, Matt. Good afternoon, everyone. I'll now walk through our financial results for the third quarter of 2026. Our commentary will focus on GAAP financials unless otherwise noted. Total revenues for the third quarter of 2026 were $353.2 million compared to $120.7 million for the same period in 2025. The increase was primarily driven by growth in Attruby net product revenue and $75 million in license revenue from a onetime sales milestone for Beyonttra, reflecting strong uptake in Europe due to our differentiated product profile and excellent commercial execution by our partner, Bayer.

U.S. Attruby net product revenue in the quarter was $253.2 million compared to $108.1 million in the same period last year. Royalty revenue was $20.5 million compared to $4.3 million in the same period last year, primarily earned from net product sales of Beyonttra in the EU and Japan. Total operating expenses for the third quarter of 2026 was $344.4 million compared to $259.3 million for the same period last year. The $85.1 million increase reflects continued investment in tube and preparations for our three upcoming launches.

Turning to the operating line. In the third quarter, we recorded an $11.6 million loss from operations compared to $145.2 million loss in the same period last year. The improvement was driven by growth in Attruby net product revenue, higher Beyonttra royalties and a $75 million Bayer sales milestone, partially offset by a disciplined increase in OpEx. Aside from the onetime impact of this milestone, the operating line was particularly strong in 3Q due to timing of expenses related to our three upcoming launches. We anticipate OpEx will catch up in the fourth quarter of this year, followed by a more modest steady growth paired with improvement of the operating line throughout 2027 and beyond.

Now on to the balance sheet. As of September 30, 2026, our cash, cash equivalents and marketable securities were $1.5 billion, representing our strongest reported cash position in the company's history. Our strong cash position, together with our improved financial trajectory allows us to fully resource our next phase of growth, including our upcoming launches and continued investment in Attruby, while also investing in label expansion of life cycle management.

With that, I'll turn the call back over to Chinmay.

Chinmay Shukla

Thank you, Neil, Matt and Tom. Operator, please open the line for questions now.

Operator

[Operator Instructions] Your first question comes from the line of Cory Kasimov with Evercore ISI.

Question-and-Answer Session

Cory Kasimov

I wanted to ask about Attruby. Obviously, there's been a lot of debate around how to think about quarter-over-quarter growth. So you put up a sequential increase of $31 million this quarter. Is that still the right base to build off of as we think about Q4 and into next year? Or maybe asking it another way, what would need to happen, whether it's first-line share market growth broader recognition of the compelling real-world evidence you've been building or something else for that number to step up from here?

Chinmay Shukla

Hi, Cory, thank you for the question. We do think that, that $25 million to $30 million is the right number near term. And eventually, it will go up more from there. But let me pass it on to Matt, our Chief Commercial Officer, to expand more upon that.

Matthew Outten

Yes. Thanks, Cory. So I mean, we're really pleased with our Q3 results and the continuation of what's been a very strong launch for Attruby. As we've discussed previously, we're really focused on the first-line setting. I think that's where everyone is sort of looking and we believe this is where the most growth can be found, and this is where we've been growing the most with Attruby. It's pretty clear that stabilizers are the therapy of choice in the first line and as the only near-complete stabilizer in ATTR-CM, we feel that Attruby is very well positioned for continued growth. There's still a lot of opportunity to diagnose and treat patients just due to the really high number of undiagnosed patients. And as you heard Neil discuss in his initial comments, that incredible real-world evidence and renal protective data for Attruby, we've just started getting that out into the market. And we believe that this type of data is going to continue to drive share for Attruby in Q4 and also beyond.

Operator

Your next question comes from the line of Tyler Van Buren with TD Cowen.

Unknown Analyst

This is Nick on for Tyler. So you mentioned Q4 and moving forward. But as you think about next year and the new 340B plan going into effect, how could this possibly or positively impact the Attruby sales and potentially increase some new accounts coming online or increased prescribing patterns. Any thoughts on that would be very helpful as well as anything that you guys are seeing in Q3 in terms of new patient starts, breadth of prescribers and persistence of treatment that could be leading indicators moving forward would be really helpful.

Chinmay Shukla

Hi, Nick. Thank you for the question. I'm going to pass it again to Matt to discuss this.

Matthew Outten

Sure. Let me break it up into the two sections that you sort of described. So as I was just discussing, Attruby really growing well in the front line, but I can elaborate a little bit with some of the metrics that we look at when we think about how we're doing and what to consider in the future. Our gross to net remains and has been very stable for a Attruby. And our persistency and compliance rates are extremely strong and high. So I think those two things in particular, something we watch closely and they've been very consistent for us. We may have seen our recent marketing campaign of speed, strength and stability, which highlights how quickly Attruby works and how well it keeps patients out of the hospital. Those two things have been since launch and continue to be two of the main reasons that physicians reach for a specific medication. We have the best team in the industry, so I have to throw out that, of course. And then one last thing to consider, too. The number of new prescribers who use Attruby in the first line continues to expand with consistent growth every single quarter. And as we've reported previously, when someone uses Attruby, they tend to keep doing it over time, which is going to lead to long-term increase in prescription and share for attribute prescriptions. And then on your second point, regarding ASP, I think much like the IRA change with Part D, the proposed ASP change really helps level the playing field. I need to stress, there's no way to know if the change will pass and what it will look like. But if it does, it's important to know that it impacts Part B, as in boy, medications, not Part D, as in David, medications like Attruby. So there is no negative impact on Attruby regardless of what passes. We could see a positive impact, but we really have to wait and see what that final legislation looks like. So I would say stay tuned. The expectation is that we're going to hear on that fairly soon.

Chinmay Shukla

Yes. And just to build on what Matt said, I think I wanted to just highlight what Neil mentioned in his prepared remarks in terms of trying to go after the long tail of prescribers and really expanding the prescriber base, I do think that, that is going to be one source of growth in the future for Attruby in the U.S. And then just the other thing we wanted to highlight here, Nick, is in terms of leveling the playing field, Europe is a very good example of what a market with a level playing field looks like. We're extremely excited to see Bayer's very strong launch of Beyonttra in Europe. I think the Beyonttra is now the leading brand in Europe. And you can see that even in our third quarter, we had a little more than $20 million of priority revenue. And of course, we received the $75 million sales milestone slightly ahead of expectations. So we feel good about where things are, and we feel good about where things are going to be even better if the playing field gets levered.

Operator

Your next question comes from the line of Josh Schimmer with Cantor Fitzgerald.

Joshua Schimmer

A question on capital allocation, but maybe in two parts. As you expand the Attruby sales force to address the long tail of subscribers, how do you think about the importance of acquiring another product to improve the efficiency of the calling efforts. And then of course, there's a lot of chatter around the prospects of acquiring the outstanding ownership of Gondola to reintegrate that pipeline. So how do you think about the -- both of those potential opportunities?

Chinmay Shukla

Yes, Josh. Thank you for the question. So maybe I'll try and unpack some of this. So yes, I think we're very excited about Gondola's progress. They have a deep and exciting pipeline, and they have some very talented leaders running the company and James Morgan and Peter. Having said that, I think as Neil mentioned in his prepared remarks, for BridgeBio, we're focused on execution here because we have a broad opportunity in front of us with Attruby first of all, as you mentioned, trying to go after the long tail. Our field force is rightsized, but I think that it is going to require some investment. I think where we think we can innovate here is using AI and other tools to really think about what a modern commercial organization looks like and obviously being here in the valley is very helpful for that. So I think that is our big focus. I think we are also extremely focused on launching these next three products. I think that we have the opportunity to help a very large number of patients and really significantly grow our top line revenues. And then finally, I think that there's a lot of exciting pipeline activity at Dredge both with the hypopara Phase III trial, which I think will read out in early '28 as well as the antibody program, which we just announced today, we've nominated a discovery candidate and which we think could be in the clinic, not too distant of the future. So that's what we are focused on today. And maybe just taking a step back since you asked us our thoughts more broadly on capital allocation. First, use of capital is operations and fully funding the operations so that, that comes first before anything else. For any excess capital, we think about three options. The first is just retaining the cash on our balance sheet and getting optionality value. Second is to grow our pipeline, whether it's through M&A or through like integrating our sister company, things like that. Third is buying back shares, which obviously, as you guys saw in our Q, we bought back a few shares in September. The way we decide about it is we look at what the IRR is on all these opportunities, and we think about what our long-term shareholders will reward the most. So we really do think about shareholders before we make any of these capital allocation decisions. And my hope is that this color helps you guys understand how the company will invest its capital.

Operator

Your next question comes from the line of Biren Amin with Piper Sandler.

Biren Amin

Maybe another on the balance sheet. You've got about $1.5 billion of cash and three product launches in the near term. How should we think about funding needs of Attruby and the new launches? And do you have what you need to get the profitability with the current balance sheet?

Thomas Trimarchi

Hi, Biren, this is Tom. Good to hear from you. So yes, a very strong balance sheet, as you mentioned, with $1.5 billion of cash today. I feel very comfortable with the cash that we need to continue executing on Attruby and to launch three products in a way that's disciplined, but a resource to win certainly in these critical markets and these communities that they're trying to serve here. So just piggyback on Chinmay's earlier comments, I feel like operational cash needs are well covered by the $1.5 billion of cash. And you can see that our cash flow from operations generally has been on a downward trajectory. Maybe to connect that a little bit with how we see the P&L evolving as well. So we're three quarters of the way through 2026. I'm fairly confident that we'll average operating loss of around $90 million to $100 million a quarter this year. That's a big improvement from where we were at last year. That was about $130 million loss a quarter last year. And we were able to achieve this while ramping up sales and marketing expense were coming through the launch is really due to the fact that we're starting to see operating leverage from the Attruby brand. So as we look forward to next year, I see a continued margin expansion from Attruby, an improving operating line throughout the course of the year in terms of breakeven point. And this is really going to take us into 2028 where you get to the place where all four of the brands have a chance to be probably on a last stand-alone basis and then [ infi ] can really kind of take a unique shape where you got a very interesting and dynamic top line there, that was very strong and evolve the bottom line as well.

Operator

Your next question comes from the line of Eli Merle with Barclays.

Eliana Merle

Just wanted to ask about the [ Ascendas ] citizens petition on infigratinib. Can you address how you're thinking about that? And do you see any impact on the review time line or on the label? And second, I guess even if it's just from a perception perspective for physicians and families. How are you thinking about the commercial implications of this and how you're addressing the perception with education and awareness around the safety and neurocognitive profile.

Chinmay Shukla

Hi, Eli. Thank you for the question. It's great to hear from you. I'm going to pass this one on to Justin To who leads the infigratinib franchise.

Justin To

Yes, thanks so much. So first, we do not anticipate that this will impact our review timeline or label. I think there were a lot of false assertions and assumptions in this business position. And candidly, we think this tactic reflects how concerned they are at our [indiscernible] launch. It's unfortunate to have resort to a clear misuse of the citizens petition mechanism, especially since they were just complaining about Barmer doing the exact same thing to them about a year ago. We know the agency historically does not look favorably competitions being used for competitive purposes. And we also know from the previous Barmer in Sentosaga that advocacy groups here and clinicians in this space care a lot about having choice. And ultimately, we believe that or will come back to in here. Now the concerns that they raised have been disputing time and time again. First, the studies at this site reflect full genetic knockout in mice, which everyone knows is very different than partial pharmacological [ impedition ] of a target. Non-clinically, we conducted all the required tox studies with detailed CNS assessments. And this is required really for any program before you start a Phase II study, well in Phase III. In addition, we now have data out beyond 3 years, showing that there are no CNS effects are really any AEs indicative for peripheral or CNS FGF1 FGFR2 inhibition. And remember, the agency has cleared us to go even younger [indiscernible] program. And really, at the end of the day, I think they and the physician maybe would be better served. They're base spend the same amount of time and energy on entering data for their program. And when we speak to clinicians, they don't really kind of see this as a concern because they see the data that we have on hand, they understand really the balance of the argument that's being made here. And so I think this hasn't been a concern for us commercially.

Operator

Your next question comes from the line of Salim Syed with Mizuho.

Salim Syed

Just one from us on 418, if possible. So obviously, it's a holiday PDUFA here. Can you just give us sort of like the logistics around that what should we keep in mind as we head into the PDUFA just given the holiday timing? And then also just remind us, if you can, just given this was on the interim analysis. Is base case here currently full approval or accelerated?

Chinmay Shukla

Hi, Salim. Thank you for your question. I'm going to pass this one on to Anna Wade, who leads the neurovascular franchise.

Anna Wade

Hi, Salim. Thanks very much for your question. I'm pleased to say that we continue to have very positive interactions with the agency as they've been conducting their review and given that continued engagement and feedback to date, we're confident that this will be a traditional Val approval and everything is looking on track for the November 27 PDUFA action date. We're excited about the potential. Obviously, it's going to be [ 0.8 ] to save this [ LGBT2i ] community in the relatively imminent.

Operator

Your next question comes from the line of Andrew Tsai with Jefferies.

Lin Tsai

Congrats on the continued execution. In encaleret, now that the RECLAIM study has started dosing patients, can you talk about how you guys are thinking about the market opportunity for the bigger hypo-PTH market? And how should we size that relative to ADH1? And then as for the Phase III study itself, what do you guys think is the fundamental kind of efficacy bar for you to ultimately take meaningful share over your competitor?

Chinmay Shukla

Andrew, thank you for the question. I'm going to pass it to Ananth Sridhar, who leads ADH1 and hypopara for us to answer that.

Ananth Sridhar

Yes. It's a great question. And it's exciting to advance in color into this registrational study to RECLAIM HP study of encaleret in chronic hypoparathyroidism especially at a point where it is under registrational review enables us to further interrogate its clinical profile in advance this potential clinical utility for a broader population. To directly respond to your question, we estimate around 200,000 prevalent chronic hypopara patients in the U.S. and Europe. Relative to ADH1, we estimate about 25,000 prevalent ADH1 patients in those same geographies. In terms of some of our early observations from the study, where we're seeing demand to be the most strongest. It's amongst three cohorts. And Chinmay actually had touched on these in our Q1 earnings call earlier this year, those three populations are patients with persistent hypercalciuria. This is about 50% of the chronic hypopara population. Secondly, it's coming from patients with low bone mineral densities or osteopenic or osteoporotic individuals who may not be great candidates for PTH analogs given the potential iatrogenic risk of compression vertebral fractures that have been observed on those therapies. And then finally, the third population is patients with injection site reactions for [ new ] abrasion. This represents about 40% of the population based on our estimates. And these are the three cohorts that have expressed the strongest interest in our study. And then to your second question, what's the bar for success? We have a more stringent primary endpoint for this study have been seen in present studies and the indication as we're evaluating the concomitant normalization of both blood and urine, calcium of encaleret relative to placebo. Robust clinical effect first placebo paired with a consistent safety profile would meet our threshold for success. And I think with substantial a new option for patients in the community with chronic hypoparathyroidism.

Operator

Your next question comes from the line of Anupam Rama with JPMorgan.

Anupam Rama

On 418 in Europe, you noted today that you're now planning on submitting an MMA in the first half of '28 based on your interactions with health authorities. Can you give us some color on what came out in those conversations, and what's driving that timing? How should we think about the EU opportunity in limb-girdle versus the U.S.

Chinmay Shukla

Yes. Hi, Anu, thanks for the question. I'll pass it on to Anna to talk about it.

Anna Wade

Thanks for the question, Anupam. And so yes, if we -- these are based on multiple productive meetings we've had with EU national authorities. In those meetings, the feedback we're getting is they reiterate the compelling nature of the data that we were showing with improvements from baseline and by population full-cycle capacity. However, the main difference there is that these authorities indicated that they wanted to see the 36-month data as originally consulates in the protocol. And that's basically because they don't have the same regulatory flexibility in Europe as we do in the U.S. So what we're planning on doing is waiting -- completing the ongoing 36-month study in the second half of next year. And that data will be used to support the MAA filing, as we mentioned in the first half '28. In terms of the opportunity, we see this as a very meaningful opportunity considering that this is a larger population in Europe than in the U.S., and we're estimating over 4,000 patients currently in Europe with LGMD2i.

Operator

Your next question comes from the line of Derek Archila with Wells Fargo.

Unknown Analyst

Maybe just staying on the limb girdle taken care. As we think about the limb-girdle launch, how should we be thinking about modeling these first couple of quarters? I know it's early, but how should we frame that ramp? And what sort of KPIs are you willing to share as soon as -- or soon after the launch starts?

Chinmay Shukla

Hi, Derek. Thank you for the question. I'm going to pass it on to Anna to talk about this.

Anna Wade

Thanks, Chinmay, and thanks, Derek. So as you heard today, we're really excited about the LGMD2i launch and the potential benefits of BB-418 that can provide this community. We're feeling really good about the ongoing preparations to launch interactions in the field continue to be very positive and every medical meeting as well. The most requested data we hear from UCP. It has been the cardiac data based on the fact that it is such a key driver of morbidity and mortality in this disease and that day has recently shared at WMS as both Neil and Matt discussed. And so we're really feeling very good about the launch of physicians who've actually been contacting our medical team, letting us know that they're already in waiting for the potential therapy from for LGMD2i. As has also been mentioned, we've identified 500 unique genetically diagnosed patients to date, and we expect to fully penetrate that identified patient pool by as we go through the launch, we'll be sharing what we're hearing from the field, and you can expect the more quantitative metrics will further later, probably around the Q4 earnings call in early next year.

Chinmay Shukla

Yes. I think just to build on that, Derek, we always communicate very transparently on launches. And as you know, we did the same thing with Attruby. So we're going to think about what are the right metrics which investors should look at. And then as Neil mentioned in his prepared remarks, importantly, what is the right frequency at which we give those updates. So as we make those determinations, we will announce it. And but you can expect us to talk about it and to talk about how things are going once we are out in the field. We're very excited for this opportunity to potentially help patients with limb-girdle muscular dystrophy type 2I.

Operator

Your next question comes from the line of Danielle Brill with Truist.

Danielle Brill Bongero

On infigratinib, I wanted to ask about hypochondroplasia. You mentioned the Phase II/III as cell study is expanding to higher doses to find the optimal dose. Can you walk us through the rationale for going higher, what the safety data is telling you there, and how it affects the time line to pivotal data?

Chinmay Shukla

Yes, Daniel, thanks for the question. I'll pass it on to Justin.

Justin To

Yes. Thanks so much for the question. So as a reminder, the purpose of our Phase II study was to do a dose escalation 25 optimal dose. Now in achondroplasia, we stopped at 0.25 milligrams per kilogram, not because of safety reasons, but because we hit the optimal efficacy level for that indication, bringing HP back to wilted levels and show in that stage proportionality and urban. In hypochondroplasia, which is a different indication, the optimal dose might be different given the heterogeneity of mutations here in the different phenotype that's seen. And really, given the clean safety profile that we've now seen in cobalt long-term extension study as well, of course, in our hypochondroplatic a program and the fact that we don't see any FGFR1 or 2 inhibition at these doses. We feel really comfortable traditional doses and the agency has supported that decision as well. Ultimately, we're confident that we saw some distance from the [indiscernible] therapeutic index.

Operator

Your next question comes from the line of Jason Zemansky with Bank of America.

Jason Zemansky

Congrats on the great progress. I guess moving to the payer side, we're hearing a large player has started restricting first-line use of a competing silencer. Does this apply to a Attruby? And I guess, if so, which patients are affected and what does the path to access look like? I guess how should we be thinking about the impact on first-line starts and the risk of similar restrictions with other payers?

Chinmay Shukla

Yes, I'm going to pass it on to Matt to answer, Jason. And it's great to hear from you.

Matthew Outten

Yes. Hi, Jason. I think we're probably talking about United here. United hasn't made any changes to Attruby in 2026. It made a change back in mid-2025 to prefer VYNDAMAX. But Attruby's been able to continue to grow since then, since launch through all of this up until now. Our approval rates to appeal are over 90%, and attribute continues to grow quarter-over-quarter. So there's really nothing new here for Attruby. It always and especially in the Medicare market, comes down to HCP and patient preference. And if an HCP wants Attruby, they can get it for their patients, and we've shown it since launch.

Operator

Your next question comes from the line of June Lee with UBS.

Unknown Analyst

We're really intrigued by the opportunity of encaleret in chronic hypoparathyroidism as you enroll these postsurgical patients, are you tracking who has partial versus hey versus total thyroidectomies our understanding is that different postsurgical patients may present the varying degrees of severity even may have a different responsiveness to encaleret. And related to that, what is your powering assumptions for the Phase III we claim HP? And what is that based on?

Chinmay Shukla

Yes. June, thanks for the question, and thanks for the deep work, which you've done on our hypopara program. Let me pass it on to Ananth to talk more about these questions.

Ananth Sridhar

Yes. And thanks for your interest in the program. We share it. On your first question on whether we're monitoring for or assessing the extent of parathyroid tissue loss as a result of surgery or interior net injury. It's really hard to assess that. Sometimes tissue is left in C2, but it loses vascularization and enhance function. What we are going to be measuring at baseline similar to other analog studies the extent of PTH concentrations in blood calcium and urine calcium at baseline. And we'll obviously us longitudinal changes on or off treatment. In terms of powering assumptions, we are powered -- so we have randomized the study 3:1. We power the study to assess for a differential clinical benefit on achieving concomitant normal blood and urine calcium. As a reminder, we informed these estimates based on what we saw in our proof of principle Phase II with some more conservative estimates. In that study, we saw that none of the patients achieved that primary endpoint on conventional therapy, whereas 80% achieved that profile on encaleret within 5 days. So we've obviously taken some steps to be more conservative in our powering assumptions, but those signals from that study helped inform our powering estimates.

Operator

We have reached the end of the Q&A session. I will now turn the call back to Pablo Alvera for closing remarks.

Unknown Executive

Thank you, operator. Thank you, everyone, for joining us for our third quarter earnings call today. We appreciate your interest, and we look forward to updating you again next quarter.

Operator

This concludes today's call. Thank you for attending. You may now disconnect.