BridgeBio Pharma Q2 2026 Earnings Call Transcript

Quartr
Provided by Quartr
August 10, 2026

Key Takeaways

  • Positive Sentiment: Attruby net product revenue reached $222.4 million, up $150.9 million year over year and more than $35 million sequentially. Growth was led by treatment-naive, first-line patients, while the company expects additional support from kidney-protection data and real-world evidence.
  • Positive Sentiment: BridgeBio said Attruby is positioned to benefit from the failed CARDIO-TTRansform combination-therapy study, which it believes reinforces stabilizers as the first-line treatment backbone. Management expects clinical differentiation, including early outcomes and renal benefits, to support further share gains over the next 12–18 months.
  • Positive Sentiment: All three major pipeline programs advanced into regulatory review: BBP-418 for LGMD2I received priority review with a November 27, 2026 PDUFA date, encaleret for ADH1 received priority review with a May 8, 2027 target date, and infigratinib’s achondroplasia NDA was submitted. The company is building commercial infrastructure for potential launches over the next 12–18 months.
  • Neutral Sentiment: Operating expenses rose to $335.7 million as BridgeBio invested in Attruby and preparations for three launches, though the operating loss improved 20% year over year to $107.1 million. Following a $1 billion preferred-equity financing, management expects operating results to remain roughly stable for several quarters before moving toward breakeven and cash generation in 2027.
AI Generated. May Contain Errors.
Earnings Conference Call
BridgeBio Pharma Q2 2026
00:00 / 00:00

Transcript Sections

Skip to Participants
Operator

Good afternoon. I will be your conference operator today. All lines have been placed on mute to prevent any background noise. After the company's remarks, there will be a question and answer session. If you would like to ask a question, press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. 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.

Operator

For a discussion of these risks and uncertainties, please refer to the disclosure in today's earnings release and BridgeBio's periodic reports and SEC filings. All statements made here are based on information available to BridgeBio as of today, and the company undertakes no obligation to update any forward-looking statements made during this call, except as required by law. With that completed, BridgeBio, you may begin your conference.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Good afternoon, everyone, and thank you for joining BridgeBio Pharma's second quarter 2026 earnings call. I am Chinmay Shukla, Senior Vice President, Strategic Finance. With me today are Neil Kumar, our CEO, who will walk through our commercial pipeline and business updates, Matt Outten, our Chief Commercial Officer, who will provide additional detail on Attruby and our launch readiness, and Tom Trimarchi, our President and CFO, who will review our financial results. During today's call, we will cover another quarter of consistent growth for Attruby, along with new data reinforcing its clinical differentiation, including the first evidence of direct kidney protection in ATTR-CM. We will then turn to the pipeline, where this quarter, all three of our late-stage programs moved from data into being with the FDA, with our first PDUFA date now set for November 27.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

And we will review our financial position, including the $1 billion preferred equity financing completed on July 1, and how it supports the three launches ahead of us. Following our prepared remarks, we will open the call for questions. For the Q&A session, we will be joined by Ananth Sridhar, Christina Xu, and Justin To, who lead our programs with encaleret, BBP-418, and infigratinib respectively. With that, I will turn it over to Neil.

Neil Kumar
Neil Kumar
CEO at BridgeBio

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. In sessions past, we've had occasion to marry comments on the portfolio with comments regarding financing and strategy. Today, however, I want to focus entirely on the portfolio itself and the progress being made across research, development, and commercial. I'm going to do so because I believe, as I hope you might appreciate at the end of my somewhat lengthy comments, that this is an important transition point for BridgeBio, one in which, if we continue executing at a high level, sets us up well for delivering substantial returns for patients and investors alike. Put more simply, it feels like we're at T equals zero in BridgeBio's next chapter.

Neil Kumar
Neil Kumar
CEO at BridgeBio

I don't say this glibly, but rather due to the following and overlapping advances. First, as we will discuss, the combination of learnings from CARDIO-TTRansform, our own unique kidney-protective data, and extraordinary real-world evidentiary results come together to provide the basis of what I'm calling Launch 2.0 for Attruby. I believe we will start to see significant commercial fruit from this in the six to nine month range and beyond, judging from analogs. We think the market is shaping up to be a stabilizer-first market with a constrained number of competitors and one in which we have increasing numbers of proof points that our near-complete stabilizer is superior to Pfizer's partial stabilizer. Second, all three NDAs for LGMD2I, ADH1, and achondroplasia have been submitted, with LGMD2I and ADH1 garnering priority review and are hoping that achondroplasia might too.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Our commercial readiness work is on track, even ahead of what we were able to do with ATTR cardiomyopathy, given our relatively lean resourcing at the time to deliver strong launches. Third, our chronic hypoparathyroid phase III, which we believe is overlooked, has commenced and will read out in the next 18 months with potential to provide a differentiated efficacy and safety profile as we will discuss, in addition to being the only oral in the space. Finally, we anticipate novel trials in areas like Turner and hypochondroplasia for infigratinib, a new trial in a to-be-disclosed hyposthenuric orphan kidney disease for acoramidis, and the advancement of a potentially best-in-class TTR antibody into the clinic in the coming 12-18 months. All of this activity together provides a substrate for well over $10 billion in risk-adjusted revenue, with $8 billion of that being post phase III to date.

Neil Kumar
Neil Kumar
CEO at BridgeBio

In addition, our interest in earlier but still advanced genetic medicine R&D within our GONDOLA pipeline continue to bear fruit, so this is a company with no dearth of pragmatic ideas that can drive a continued flux of important medicines on a risk-adjusted basis for the next decade or more to come. I'll begin my portfolio comments with Attruby. First and most importantly, we observed continued commercial momentum this quarter, with Attruby being the fastest-growing brand in the space at 23%, and this growth does not account for the impacts of CARDIO-TTRansform, our kidney data, and most of the real-world evidence data to date, since that occurred after the quarter end. We've always said that the most important thing commercially and medically in this whole space is diagnosing new patients.

Neil Kumar
Neil Kumar
CEO at BridgeBio

To that end, we were heartened to see the substantial overall market growth of 19% this quarter, representing a 51% increase year-on-year and substantially outstripping the market growth observed in the last three quarters. Consistent with these numbers is the growth in frontline patients, where stabilizers have dominated share, a trend that we think will strengthen as we learn more from CARDIO-TTRansform's important results. Indeed, we observed a slight downtick in numbers of second-line patients in the second quarter. We believe our share in frontline has grown some 2-3 percentage points, although it's hard to tell precisely given some of the inventory dynamics from our competitor, Pfizer. Our gross profit also remains within the 30%-40% that we have indicated previously.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Going forward, we expect that the first-line market will continue to grow, and we intend to continue growing our share in it, which should translate into continued steady sales growth. Attruby's strongest tailwind, however, is its continually growing clinical differentiation story, driven for the most part by the expanding body of real-world evidence, as well as the now documented renal protective effect. In July of this year, we published in Circulation: Heart Failure on acoramidis, driving the first ever early and sustained direct kidney protective effects in ATTR cardiomyopathy, including chronic eGFR slope improvement and urinary albumin to creatinine ratio reduction. The upshot of this is that Attruby may protect the heart and the kidney simultaneously in ATTR patients, a hemodynamically mediated effect which we do not observe with other ATTR cardiomyopathy medicines, either knockdowns or other stabilizers.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Critically, as pointed out in the paper, the dynamics of this effect mirror the early separation uniquely observed with Attruby in terms of clinical outcomes, helping to explain this early impact. Furthermore, and intriguingly, the magnitude of the acute dip in eGFR on Attruby is actually important and suggestive of downstream benefit. More specifically, comparing acoramidis versus placebo subgroups with acute eGFR dips greater than or equal to the median of 4.89 mil per meter per 1.73 m sq favored acoramidis for all-cause mortality or cardiovascular-related hospitalization with a whopping hazard ratio of 0.42 with an associated P value of 0.006 and cardiovascular-related hospitalization alone with a similarly impressive hazard ratio of 0.34 with an associated P value of 0.002. Intriguingly, within the placebo arm, eGFR dips portended worse outcomes. So something initially thought to be a crutch has now been shown to be an important differentiator for our product.

Neil Kumar
Neil Kumar
CEO at BridgeBio

The observed effect compares favorably to what we see in other kidney protective cardiac treatments like SGLT2 inhibitors. In a recently held meeting of nephrologists and cardiologists, one KOL explained to me, "It looks like you have a kidney drug here." Building on that, as referred to above, we intend to further interrogate this signal by conducting clinical studies in an orphan kidney indication. More information on that in the weeks to come. Meanwhile, the generation of real-world evidence continues apace. When one looks at analogs in the cardiovascular space where double-blind head-to-heads were not immediately possible, real-world evidence sets the bedrock of ultimate commercial outperformance. The most storied of these analogs is likely the ELIQUIS/Xarelto marketplace. Calling back to last quarter, there was an independent propensity score-matched analysis presented at SCAI and since published, which continues to resonate with physicians.

Neil Kumar
Neil Kumar
CEO at BridgeBio

That analysis associated Attruby with a 37% reduction in composite cardiovascular events and a 34% reduction in hospitalizations at six months relative to tafamidis, with an effect deepening at nine months. Remarkably, there was no observed clinical outcome that did not favor Attruby versus Vyndamax in all measures except for dizziness and syncope, reached statistical significance of less than 0.01 with an N just shy of 600 patients. Building on this data, we have our own now soon to be published and available online today preprint analysis that parenthetically has been downloaded more than 400 times now, showing again Attruby outperformance as compared to Vyndamax. Importantly, in this study, a 34% reduction in diuretic intensification, heart failure hospitalization, and mortality was observed, again, statistically significantly, and separation is again observed as early as 30 days and continues to improve over time.

Neil Kumar
Neil Kumar
CEO at BridgeBio

These types of analyses are what the community has been asking for. Importantly, a large-scale independent EHR-based analysis will be coming at HFSA. Our hope is Attruby continues to perform well there, and that then these several RWE studies will form the basis for decision-making and guideline updates. The growing body of research supporting Attruby's clinical differentiation will take place alongside evidence from other studies in this rapidly evolving field of ATTR cardiomyopathy. Last month, as you all know, the top-line results for CARDIO-TTRansform studying eplontersen in ATTR cardiomyopathy read out, and the study did not meet its primary efficacy endpoint with no benefit observed with combination therapy. At this point, we mostly want to acknowledge that this is a blow to the patients who participated in the trial and their families and the investigators, and we feel for them as part of the ATTR cardiomyopathy community.

Neil Kumar
Neil Kumar
CEO at BridgeBio

The case for combination therapy seems today null from a trial data perspective. Given the similar degrees of knockdown between eplontersen and patisiran, we will be interested to see how the knockdown performs in two settings. Number one, does the monotherapy relative risk reduction continue to underperform what we observed from Attruby at 30 months? And two, does monotherapy knockdown actually not outperform a partial stabilizer in tafamidis, as we actually observed in HELIOS-B? Recall, of course, that in addition to the real-world evidence I just cited, everywhere we looked in our ATTRibute-CM trial, acoramidis outperformed tafamidis. The conclusions of this important study run by AstraZeneca and Ionis, we believe, will likely reinforce the case for stabilizers first.

Neil Kumar
Neil Kumar
CEO at BridgeBio

If the monotherapy benefit, again, lags in time, as was observed with vutrisiran, and in magnitude of effect as compared with Attruby, we believe this begins to make an even stronger case for using Attruby first in the second-line setting. Now I would like to discuss the three pipeline programs that have moved into regulatory review this quarter and which we are preparing to launch. For BBP-418, our LGMD2I program, the FDA accepted our NDA on May 27th with priority review. The PDUFA date is November 27th, 2026, and there is no advisory committee planned. We continue to have positive interactions with the agency. This is in line to be the next approval in our portfolio, and it would be the first approved therapy for LGMD2I, a devastating condition affecting a little more than 1,000 patients in the U.S. alone with significant unmet need.

Neil Kumar
Neil Kumar
CEO at BridgeBio

There is really no displacing credible competition in this space, with gene therapy really the only other pipeline approach, and it suffers from safety and efficacy issues, coupled with the fact that too much FKRP is toxic, so dosing might well be an issue. I will remind everyone as well that the data generated by our program are easily the most profound ever in the LGMD space and perhaps the broader muscular dystrophy space, given that biochemical improvements tied strongly to functional and statistically significant improvements in ambulation, breathing, and other outcomes, and that the drug promoted improvements as opposed to the ever-worsening observations on placebo. From a clinical perspective, our goals are, number one, to educate broadly on already established data, and two, to reinforce our observations in the non-ambulatory and severe patient population that may initially be reluctant to try anything.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Recall, we observed remarkably consistent benefit in our trial across ages, degree of severity, and the homozygous and compound heterozygous populations. Building on that, we will be analyzing whether our established functional impacts also marry with some cardiovascular benefit, which affects many patients on the severe end of the spectrum. Our plan is to cut that data and present the results at World Muscle Society in late September, early October, so we are hopeful for a good outcome for the patients we serve there. As we prepare for launch, our neuromuscular commercial and medical field teams are hired, trained, and in the field, and market access is engaging with payers in a pre-approval information exchange. There are approximately 500 genetically confirmed patients today in the U.S., with many who remain unidentified and misclassified within the broader LGMD or Becker muscular dystrophy space.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Our goal is to find every patient who can benefit and be ready the moment we are able to reach them. Turning to encaleret for ADH1, the FDA accepted our NDA on July 22nd with a PDUFA target action date of May 8th, 2027, and no advisory committee planned. At the end of July, the agency granted priority review, and we have announced that today. We have also submitted our MAA to the EMA on July 27th, and it is under review. Encaleret would be the first therapy approved for ADH1 in both the U.S. and EU, and we are excited to serve this patient population. Speaking of that population, our patient finding efforts continue, and more than 2,200 patients have been identified in the ICD-10 claims between October 2023 and June 2026.

Neil Kumar
Neil Kumar
CEO at BridgeBio

That is an increase of about 300 since the first quarter, and it has been driven by genetic testing, awareness education, use of the ICD-10 code, and BridgeBio-supported family testing events. We have also completed enrollment in the first of four cohorts in our pediatric ADH1 study and are preparing to open cohort two. ADH1 approval is the beginning of encaleret's potential, not the end. Chronic hypoparathyroidism affects some 200,000 patients in the U.S. and EU, a blockbuster opportunity in and of itself, where, as discussed last quarter, we see a real appetite for an oral option that corrects both hypocalcemia and hypercalciuria. I want to spend a minute on this opportunity because I think it has been overlooked significantly by investors. First, there may be a belief that PTH replacement is the beginning and end of the game here.

Neil Kumar
Neil Kumar
CEO at BridgeBio

With advances around dosing, for instance, going from daily to weekly, being the only salient dynamic for patients. That overlooks a couple key facts. First, the benefits of existing therapy do not importantly extend to normalization of urine calcium, with some 40% of patients not normalizing and some 50% of CHP patients actually being hypercalciuric. Second, there is a well-documented decrease in efficacy of PTH replacement over time, suggesting that other approaches may be important here. Third, perhaps most importantly, there is a need for a drug that spares the impact of PTH-mediated bone issues, especially considering that in a recent survey of 160 patients, 48% of them had osteoporosis or osteopenia. Fourth, that many individuals would prefer an oral medicine. I think some may have discounted this opportunity based on likely probability of technical success. That, I believe, is a mistake. First, the pathomechanism here is well described.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Recall first that the hypercalciuria in chronic HP arises from three independent contributors. One, loss of calcium reabsorption at the distal nephron that's PTH-driven. Second, decreased calcium reabsorption in the thick ascending limb that's calcium sensing receptor-driven. Third, obviously exacerbation by conventional therapy. Analogous to PTH activity in the kidney to mediate reabsorption of calcium, encaleret's action on the calcium sensing receptor has been shown to increase paracellular reabsorption of calcium in the thick ascending limb by reducing claudin-14 expression, which in turn decreases the amount that integrates into the claudin-16/claudin-19 complex, which acts as a calcuria promoting poor blocking component. This mechanistic rationale helps to explain the observation from our proof of concept phase II, where 80% of post-surgical hypoparathyroid patients administered with encaleret achieved both normal blood and urine calcium within five days.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Okay, so we understand how negative allosteric modulation of the calcium sensing receptor can mechanistically raise serum and lower urine calcium even in a wild-type setting. For those of you who don't want to bet on mechanism, recall also there's clinical evidence in the wild-type setting that exists for these drugs, namely the extensive data from the Legacy Clinical Development Program of encaleret in osteoporosis participants expressing wild-type calcium sensing receptor like the chronic hypoparathyroidism population that we intend to study in the RECLAIM-HP trial. Recall that in that osteoporosis study, the drug demonstrated dose proportional increases in serum calcium at daily doses of 15 mg or above. So we believe, given the endpoints of serum and urine calcium normalization, with all that we seem to know and the stability of those endpoints statistically, that we have a high probability of technical success trial on our hands.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Secondly, investors may believe that the opportunity is not near term, but this is a relatively quick trial given the aforementioned endpoints and the rapidity of onset of our drug. As mentioned in our press release, we have already activated our first sites for the RECLAIM trial, our global phase III, and have begun screening with FTI imminent and a trial readout expected in the next 18 months. Okay. Finally, I'll come to infigratinib, our oral treatment for achondroplasia, where we presented our phase III PROPEL 3 results at the International Conference on Children's Bone Health on June 30th, and simultaneously published them in The New England Journal of Medicine, the only achondroplasia program with phase III results in The New England Journal of Medicine. Following that publication, I'm excited to announce we've submitted our NDA, and we are targeting an NDA submission in Q4 of this year.

Neil Kumar
Neil Kumar
CEO at BridgeBio

We hope to see NDA acceptance and ideally priority review in Q4 of 2026, with approval following in mid-2027. Approval would make infigratinib the first FGFR3 targeted oral therapeutic for achondroplasia. On top of its oral dosing advantage, it remains the only therapy with efficacy measures beyond annualized high velocity demonstrated in a placebo-controlled setting at 52 weeks, including proportionality. Adding to this, we demonstrated a clear functional differentiator in our phase III results with a statistically significant 0.37 standard deviation improvement on arm span with a p-value of less than 0.0001. This is the first ever placebo-controlled arm span benefit in an achondroplasia trial. We look forward to presenting more data in the second half of this year and continuing to build infigratinib scientific story through the pre-approval period.

Neil Kumar
Neil Kumar
CEO at BridgeBio

On the commercial front, our regional sales directors and medical affairs personnel are onboarded and the field medical team is fully built. Our RSDs are building teams for meaningful share of voice in a market where two competitors are already present and where we see a real gap, especially in the U.S., between kids confirmed to have achondroplasia and those on treatment. We continue to think our peak achievable share in this space is above 65%. Finally, I also want to make mention of the critical work occurring off our balance sheet at GondolaBio, where BridgeBio shareholders retain exposure via our ownership stake and ongoing operational support. Our program in EPP announced positive phase II-A data in June, and following a productive EOP2 meeting with the agency, we will be initiating a phase II-B/III study in Q3 of this year.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Critically, given the 80% plus magnitude of PPIX reduction, coupled with the quick onset of action and safe profile, the agency suggested that the 2B could form the basis of registration if PPIX lowering was met statistically and other functional trends lined up with it from the point estimate standpoint. Meanwhile, the rest of the pipeline continues to progress with some 17 programs and indications including ADPKD, alpha-1 antitrypsin, neurofibromatosis type one, and CMT1A. In total, the activity has potential to yield five additional INDs by the end of this year, with some eight clinical proof of concept readouts to come in the 2027, 2028 timeframe. Of course, despite all of this, we continue to stay focused on delivering our important medicines to patients in the commercial setting. For more information on that, I will pass it over to Matt.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

Thanks, Neil. Q2 was another strong quarter that demonstrated consistent growth in the treatment-naive segment for Attruby, as physicians are increasingly starting and keeping patients on Attruby. Net product revenue was $222.4 million, marking another quarter of $35 million or more of sequential sales increase. I want to spend a moment on the composition of that growth, because that is the part that matters most for how we think about the franchise from here. The engine is the first-line. Our first-line share stepped up again in Q2 on a first-line market that held roughly steady quarter-over-quarter, and new patient starts were consistent with the first quarter. That is the durable driver of this franchise, and it is what we are building against. The second line or switch segment is behaving differently, and I want to be clear about it.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

The forced Vyndaqel switching that inflated that pool in the fourth and first quarters has now largely been worked through. At roughly 18 months post-launch, the switch opportunity is settling into a lower and more normalized steady state. What changed there is the size of the pool, not our performance within it. The shape of our growth is evolving. Continued first-line strength partially offset by a smaller switch market. That is the mix we would expect going forward, and it is the mix we are planning around. Neil covered the clinical differentiation data, so I want to speak to what it is doing commercially because this was a meaningful quarter on that front. The endpoints Neil walked through are the ones practicing cardiologists manage week to week, such as hospitalizations, diuretic escalation, and kidney function.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

Because much of that work was conducted independently of us, it carries a credibility with physicians and with payers that sponsor-generated data does not. We expect additional independent real-world work to read out over the balance of the year. On CARDIO-TTRansform, the outcome was disappointing for patients who had hoped combination therapy would improve on stabilizer monotherapy. What it did do is reinforce stabilization as the first-line standard of care. As the only near-complete stabilizer available, we believe Attruby is well-positioned in that setting. That said, the first line remains competitive, and we expect it to stay that way. Our job is to keep earning share on the strength of the data quarter by quarter. Neil noted last quarter that we expected acoramidis to reach blockbuster status in 2026, and we remain on track for that.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

To be precise about what sits inside of that number, we are referring to worldwide sales of acoramidis, which includes Beyonttra sales recorded by our partners outside of the U.S. It is not a forecast for the U.S. Attruby net product revenue. For the balance of my time, I want to focus on the three approvals ahead of us. The Attruby launch gave us much of the infrastructure any future launch requires, and we have been hard at work making sure each of these goes as well as that one did. These would be the fourth, fifth, and sixth launches in BridgeBio's history. Let me take them in expected order of approval. First, BBP-418. LGMD2I/R9 has never had an approved therapy. Approval would mark the first for LGMD2I/R9 and the first for any form of limb-girdle muscular dystrophy.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

We have submitted a brand name and have conditional acceptance of a proposed proprietary name from the FDA, which we will announce at approval. Our field medical team, sales leadership, and sales team are hired and in field. More than 95% of the sales team has prior neurology experience, with an average of nine years in rare disease. These patients are diagnosed and managed by neurologists and neuromuscular specialists working with a multidisciplinary team, so our target universe is concentrated. Roughly 700 institutions and 5,300 target specialists with priority reach against approximately 150 parent MDA centers. Ahead of any approval, the team is focused on disease state education and genetic testing awareness, and we continue to build a scalable patient identification engine that has already identified eligible patients.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

We are also engaged with payers through pre-approval information exchange so they understand the value story ahead of the decision, and we will bring the same patient support programs that have supported our prior launches. Second, encaleret in ADH1. At the end of July, the FDA granted priority review for encaleret. The PDUFA target action date is May 8, 202, and no advisory committee meeting is currently planned. We have built an equally strong field team here with nearly 90% bringing rare disease experience. ADH1 is a genetically distinct condition driven by gain-of-function mutations in the calcium sensor receptor, which causes low serum calcium, low or inappropriately normal PTH, and a more pronounced increase in urine calcium than hypoparathyroidism generally. Encaleret is designed to target that receptor directly with the potential to address both serum and urine calcium.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

If approved, it would be the first therapy specifically indicated for adult and adolescent patients with ADH1. As with BBP-418, we are engaged early with payers so that the clinical rationale is well understood before a decision. Third, infigratinib in achondroplasia. We have submitted the NDA, and we anticipate approval in mid-2027. Unlike the other two launches, infigratinib enters a market where competitors are already established. We have delivered against that kind of setup before. What we hear consistently from families, from our HCP and community steering committees, and from market research is that there is real anticipation for an oral option and awareness of infigratinib is high. The ability to give this medicine as a small once-daily capsule is about considerably more than convenience.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

Aversion to injections is one of the primary barriers keeping families from starting treatment at all, one of the leading reasons they discontinue, and a persistent burden on daily routines and family dynamics. Infigratinib can be swallowed, or the capsule can be twisted open and sprinkled over food. No refrigeration, no reconstitution, no working out how to travel with it, no injection site reactions, and no shots. Families and physicians also see the differentiation as more than the capsule. They consistently point to the efficacy in the PROPEL 3 program and, in particular, the proportionality data in the pre-specified three to eight-year-old subgroup. Operationally, our commercial infrastructure continues to build, and we are being deliberate here because this community is unique and requires a different kind of support when families are weighing whether to start therapy.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

Our partnership with the achondroplasia community over the past seven years is underpinning how we are approaching this launch. In short, we are on track across all three programs. With that, I'll turn the call over to Tom.

Tom Trimarchi
Tom Trimarchi
President and CFO at BridgeBio

Thank you, Matt. Good afternoon, everyone. I will now walk through our financial results for the second quarter of 2026. Our commentary will focus on GAAP financials unless otherwise noted. Total revenues for the second quarter of 2026 were $243.7 million, compared to $110.6 million for the same period in 2025. The $133.1 million increase was primarily driven by a $150.9 million increase in Attruby net product revenue. Attruby net product revenue in the quarter was $222.4 million, compared to $71.5 million in the same period last year. Royalty revenue increased to $15.4 million compared to $1.6 million in the same period last year, primarily earned from net product sales of Beyonttra in the EU and Japan.

Tom Trimarchi
Tom Trimarchi
President and CFO at BridgeBio

License and services revenue was $5.8 million compared to $37.4 million in the same period last year, which included a one-time $30 million regulatory milestone recognized under the Alexion agreement following pricing approval in Japan. Total operating expenses for the second quarter of 2026 were $335.7 million compared to $241.2 million for the same period last year. A $94.5 million increase reflects deliberate and disciplined investment in Attruby and preparations for our three upcoming launches, and was primarily driven by scale-up of sales, marketing, medical affairs, and pre-commercial product supply-related activities. Turning to the operating line. In the second quarter, we recorded a $107.1 million loss from operations, compared to a $134.3 million loss in the same period last year, an improvement of $27.2 million, or approximately 20% year-over-year. Now on to the balance sheet.

Tom Trimarchi
Tom Trimarchi
President and CFO at BridgeBio

As of June 30, 2026, our cash equivalents, and marketable securities were $720.2 million. Subsequent to the quarter end, on July 1, 2026, we closed a $1 billion preferred equity investment led by Sixth Street, with participation from HealthCare Royalty Partners, putting our cash balance at approximately $1.7 billion as of July 1, 2026. We believe our current cash position provides us with a significant runway to fund our operating activities, execute on three potential launches over the next 12 months, and continue to invest in Attruby's commercial growth, all while maintaining the financial discipline we have demonstrated to date. With that, I will turn the call back over to Chinmay.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

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

Operator

Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. We ask that you please limit yourself to one question to allow everyone an opportunity to ask a question. We'll go first to Tyler Van Buren at TD Cowen.

Tyler Van Buren
Tyler Van Buren
Analyst at TD Cowen

Hey, guys. Good evening, and congratulations on another strong quarter. It's great to see the more than $35 million in sequential U.S. revenue that Attruby added again this quarter. As the release specifically calls out Attruby growth led by the treatment-naive segment as physicians increasingly start and keep patients on Attruby, can you discuss what is driving that consistency in the first line? Perhaps most importantly, given competitive developments, why those drivers are durable? Perhaps you could also layer that in with expectations for the potential impact that the CARDIO-TTRansform failure and upcoming data at ESC could have on Attruby's treatment-naive share as well.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Thanks, Tyler. I'm going to pass it on to Matt to comment on some of the commercial dynamics. Then I'll pass it on to Neil if he wants to add things on CARDIO-TTRansform expectations at ESC.

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

Okay. Thanks for the question, Tyler. I think there's two interesting components here. There's the reason that Attruby has done so well to date, namely how quickly Attruby separates from placebo, along with the incredible reduction in hospitalization rates. Then there's the new data that Neil discussed today. The performance you've seen to date has been rooted in the clinical differentiation story. Now we can add to that with compelling insights from the real-world evidence, kidney data, and CARDIO-TTRansform. This is going to add on to the earlier messaging and continue to push share forward in the future. I'll let Neil add on with the CARDIO-TTRansform thoughts.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Yeah. Thanks, Tyler. I guess I would just say, we have to see what the data looks like. But by and large, I would expect that stabilizer frontline will do nothing but gain from the CARDIO-TTRansform dataset, so just be a larger pool. And in that pool, I think to Matt's point, we continue to differentiate, and I think we are going to see the fruit, as I mentioned in my comments, of the real-world evidence kidney differentiation appear really half a year from now or so. If you look at analogs, it generally takes about six to nine months to pull through some of this data. Obviously, also dependent on what HFSA looks like in terms of the independent RWE analysis. But if everything continues to go the way of Attruby, as you well know, it is sort of like

Neil Kumar
Neil Kumar
CEO at BridgeBio

Yeah. As you start to connect all the dots from biochemistry to serum TTR, every mg per deciliter is a 5% decrease in mortality risk at 30 months to all of the real-world evidence against both survival. At least we will see that at HFSA, and we saw some hints of that with the Ahmad and independent Moore data around the time that we launched and hospitalization and ODI as we mentioned today. I think all of that comes together to say we have a superior stabilizer, and that is really the message we have got to continue to hit. My expectation would be that we really hit a positive second derivative here and continue to grow pretty aggressively in the front line over the coming 12 to 18 months. But we will have to see.

Operator

We will go next to Cory Kasimov at Evercore ISI.

Cory Kasimov
Cory Kasimov
Analyst at Evercore ISI

Hey, good afternoon. Thanks for taking my question. Perhaps not surprisingly, I also want to ask a question regarding CARDIO-TTRansform missing the primary endpoint. At this point, we obviously know there was substantial background stabilizer use, and putting the silencer on top of it did not improve outcomes. I know you touched on some of this in your prepared remarks, but in your view, does this not only cement stabilizers as kind of the first-line backbone here in future treatment, but also do you have any feedback at this point from your KOLs and payer discussions as to how prescribing and reimbursement of any combination therapy may evolve from here? Thank you.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Yeah, thanks for the question. Maybe I'll start, and Matt, you can add on. I'd say it's a little early for us to get feedback from payers. On the KOL side for sure, we've been hearing, I think, a bit of surprise, honestly. There are folks that can be convinced with biochemistry and biophysics, but I think a large trial like this convinces a lot of folks and might be changing folks' minds. I do think stabilizer will be an increasingly large part. They already are a large part, but an increasing large part of the front line, and I think that's where the real action will be in this category. I'd say the three things that we're looking for with regard to CARDIO-TTRansform, I do think eplontersen and vutrisiran have a very similar knockdown profile.

Neil Kumar
Neil Kumar
CEO at BridgeBio

We have to look at the pharmacokinetics and see whether eplontersen is slightly superior to vutrisiran because vutrisiran obviously took a long time to get to its mean max knockdown. But that'll be the first thing that will be intriguing to look at. Then within the context of the clinical data, first and foremost, what's the 30-month data look like? Is anyone getting to 340, 250? To Matt's point, how quickly are folks separating in terms of effect? Because I think if you look at the totality of evidence, my suspicion will be that not only do you get the magnitude of relative risk reduction that basically Attruby will look superior at 30 months.

Neil Kumar
Neil Kumar
CEO at BridgeBio

But if there's no early separation, it really starts to suggest that you ought to be using Attruby in that switch setting, just given both its magnitude of benefit and the early onset, now well-described by this kidney data that we've put out and we'll continue to elaborate on. I think the second super intriguing point will be to see whether or not monotherapy knockdown actually outperforms a partial stabilizer. I know you and I have chatted about this, but people sometimes forget that in HELIOS-B, in that Lotella et al. Journal of the American College of Cardiology paper, that vutrisiran didn't significantly outperform tafamidis, which was a bit of a head scratcher to me based on the toxic monomer hypothesis until you look at the pharmacokinetics.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Here again, if a knockdown doesn't outperform a partial stabilizer, recall we've got a stabilizer that outperformed tafamidis in every single part of the ATTRibute-CM trial that we looked at in all major RWE studies. So again, it starts to establish, I think Attruby is a superior efficacious agent as compared to both knockdowns and the partial stabilizer of Pfizer. So that'll be the second big thing we're looking for. Matt, is there anything else you'd add?

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

No, that's well said. I think we're interested in seeing this full data set at ESC, but certainly the results don't appear to support combination therapy, which then reinforces stabilization as the backbone of therapy. Again, your comments, I think on the partial stabilizer versus a near complete stabilizer, that's where we are, and I don't think anything we see at ESC is going to change that based on the initial results that were posted.

Operator

We'll go next to Ellie Merle at Barclays.

Ellie Merle
Ellie Merle
Analyst at Barclays

Hey, guys. Thanks for taking the question, and congrats on all the progress. The Pfizer release cited net price erosion from new payer contracts while your gross to net has remained stable within the range you've guided to. Given Attruby launched at a list price below tafamidis, do you see any need to respond on price, or is clinical differentiation carrying access and share on its own? Thanks.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Yeah, thanks, Ellie. That's an important question. I think we'd like clinical differentiation to continue to carry the day here. There's no way that we could respond and meet Pfizer's rebates if they're going to be aggressive in that channel. Nor do I think we need to. I think we've had productive discussions with our partners all the way through basically the channel. They understand what we're trying to accomplish in terms of clinical differentiation, in terms of the added reduction in hospitalizations. Here's where the real-world evidence really comes in handy. The 35% or 34% in an independent study reduction in hospitalizations as compared to TAP, that's super meaningful. These are patients that are quite sick, quite expensive, and there's some untoward things that can also happen when you favor one brand over the other.

Neil Kumar
Neil Kumar
CEO at BridgeBio

I think long term, these brands will be at parity generally in terms of access, and then I think clinical differentiation will be where we win. We do not intend to chase anyone down the rabbit hole of trying to play near-term price dynamic games.

Operator

Our next question comes from Salim Syed at Mizuho.

Salim Syed
Salim Syed
Analyst at Mizuho

Great. Congrats on the quarter, guys, and thanks for the question. Just one from us on this heart failure publication data on the kidney protection. Obviously, the better stabilizer, everybody knows that all the real world curves show that also Attruby is better than tafamidis. Just wondering how this adds into that thinking here, like when you guys are talking to physicians, how important is this kidney protection? How meaningful is it in terms of how they're prescribing a stabilizer or choosing a stabilizer? If we drag that forward a little bit with the list price already being below tafamidis, what does this eventually mean for Attruby as the market evolves and when tafamidis goes generic? Thanks so much.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Yeah. Salim, thanks for the question. I am going to let Matt handle how the kidney data is being received by KOLs, and then I will also go back on the generic question. Matt, why don't you talk about differentiation and the kidney data?

Matt Outten
Matt Outten
Chief Commercial Officer at BridgeBio

Yeah, I think first things to note, this is new. Up to this point, it has been about the 342.50, as Neil mentioned. It is about early separation and not only how fast Attruby works, but how well it works, how many people it keeps out of the hospital, how soon you see the curves separate. That is what has led us through Q2. I think in terms of the kidney data, it is very important to physicians. You are going to see that impact moving forward, which I think is. That to me is probably one of the most exciting things about the call today because the kidney data has not been out. It is brand new. You are going to see that impact now as we move forward over the next couple of quarters.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Yeah. Just to build on that, Salim, I know we have discussed this, so I will be pretty quick on this, but we do expect the brand to keep growing even after when Vyndaqel goes generic in mid-2031 in the U.S. Really, there are five reasons for it. I think the first is Attruby is clinically differentiated. You heard a lot about that on the call today. That is driving the strength and treatment naive for us, and I think it is going to keep driving strength there. The second, which I think is less understood by folks, is that stakeholder economics in this market, especially DSPs, they do not largely support a preference for generics. I think you can also see that Pfizer has been successful in defending other franchises.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

I think that there is a potential for some upside because if Pfizer stops promoting post-LOE, that could increase relative share of voice for Attruby. I think if you look at all of this and you look at all the analysis on analogs, which I know you and Bennett have done a deep dive on it, I think that we expect that even as the post to market less potent stabilizer goes generic, the near-complete stabilizer in Attruby is going to keep growing.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Can I just build on one point that Matt made? Because I think the kidney data is super fresh. We are going to have to see in the next six to nine months how it changes prescribing behavior. But first and foremost, I think it is important because the actual mechanism of turning down toxic monomer, you would not expect to pick up impact as early as 28 days or one month. Here now you have a viable mechanism by which you have this early onset of efficacy. As I mentioned in my remarks, or I hinted at, it was previously sort of considered a harmful piece of our label. But I think now what you see is the greater that ammunition early, the better off you are later in terms of both cardiovascular hospitalization and death.

Neil Kumar
Neil Kumar
CEO at BridgeBio

That's also a profound suggestion here that I think will be very important on a go-forward basis. We've got to remember, close to 50% of patients with ATTR cardiomyopathy have some sort of kidney involvement. This protective signature is going to be an important piece, we believe, of the emerging story here and potentially an interesting piece in the story as if we can move Attruby into novel indications.

Operator

We'll move to our next question from Andrew Tsai at Jefferies.

Andrew Tsai
Andrew Tsai
Analyst at Jefferies

Hey, congrats on the solid execution. Thanks for taking my question. I think this was a quarter where all three of your pipeline programs moved from the clinic into the regulatory phases. You got LGMD submitted within five months of the top line, two priority reviews, no ad coms planned. It seems like your relationship with the FDA is quite healthy, but maybe talk to us in detail what your regulatory engagement has been like and how you're feeling about the review timelines from here. I'd also be curious about your ex-U.S. interactions, too. Thank you.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Sure. I'm happy to take that. I think first and foremost, as you probably know in the rare disease setting, the gold standard is the ability to run an RCT, a solid RCT with a placebo arm, and we've been able to do that across all three indications here and demonstrate profound functional benefits. I think one of the senior administrators at the agency once said that we're the poster child of what one tries to do, at least in the rare disease setting. It's not obviously always going to be the case. For instance, in Canavan disease, we may not be able to run an analogous trial. But certainly for these three data sets with the P values where they are, with the safety where it is. People forget that with these small molecules, we've been able to provide an exquisite safety profile.

Neil Kumar
Neil Kumar
CEO at BridgeBio

The risk-benefit is pretty straightforward as well. Based on all of that, we've had productive discussions with the agency to date, and we look forward to continuing to engage them on that front. Similarly, I'd say in Europe as well, there hasn't been a dichotomy between the tenor of our conversations there yet.

Operator

Our next question comes from Anupam Rama at JPMorgan.

Anupam Rama
Anupam Rama
Analyst at JPMorgan

Hey, guys. Thanks so much for taking the question. Just thinking a little bit about the November 27 PDUFA for BBP-418 and limb-girdle muscular dystrophy. Sounds like you guys have made a lot of progress here on the field team, the neuromuscular field team being hired, trained, deployed. Can you walk us through what the near-term focus here to be ready on your launch readiness, and then how you're going about identifying more patients heading into PDUFA to go beyond that, I think, 500 patients you talked about being identified today. Thanks so much.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Yeah. Thanks. We're going to pass it on to Christina Xu to talk about the limb-girdle launch.

Christina Xu
Christina Xu
Senior Associate of Strategic Finance and Operations at BridgeBio

Hi, Anupam. Just as a reminder, this is an opportunity where we think it's a $1 billion peak sales opportunity. We think there are 7,000 patients in the U.S. and E.U., with 2,000 to 3,000 in the U.S. In the U.S., in terms of launch readiness, we do benefit from having a concentrated prescriber base, with the majority of patients treated at about 150 MDA centers. As we mentioned, we do have a dedicated sales force that's been fully hired and trained. They're in the field now, really focused on disease state awareness and site profiling before the launch. Our MSLs are also fully trained. They've been in the field for over a month. They're also focused on disease state awareness and increasing the awareness of genetic testing. That's been key for driving increasing patient ID and genetic testing.

Christina Xu
Christina Xu
Senior Associate of Strategic Finance and Operations at BridgeBio

On the patient side of things, we have identified the over 1,500 patients who are genetically confirmed. That's actually grown over the course of the year, and we would expect it to actually continue growing. We have seen that genetic testing rates have also increased over the past nine months, and that is key to increasing the number of patients that are identified, including the fact that we now have dedicated sales force as well as MSLs in the field driving awareness. There's also a new dedicated ICD-10 code specific for LGMD2I/R9, and that's also going to help with tracking patients and just greater visibility as we commercialize BBP-418. On the payer side of things, this is an area of strength for this launch where we can really maximize access and price. The market research with payers has been consistently positive.

Christina Xu
Christina Xu
Senior Associate of Strategic Finance and Operations at BridgeBio

They've been quite receptive to the strength of our data and the unmet need on the patient side. They view the closest priced analog as the exon-skipping DMD drug as a comparable patient population for them. I guess the ones have it here, they even acknowledge that we have much stronger data because we actually have the functional data. It's not just based on biomarkers. That's an area of strength for us this launch.

Operator

We'll go next to John Boyle at William Blair.

John Boyle
John Boyle
Analyst at William Blair

Hi, team. Congrats on the strong quarter, and thanks for taking our question. I wanted to ask on encaleret. Now that you have priority review, the MAAs submitted and diagnoses are increasing each month with the ICD-10 code. Wondering if you could walk us through the launch setup into the May 2027 PDUFA date. As a follow-up with RECLAIM-HP now screening, hoping you could walk us through how you view the size of that opportunity and how you are viewing it as the next leg of growth for the franchise. Thanks.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Thanks, John. Really appreciate your question. I am going to pass it on to Ananth to talk about encaleret.

Ananth Sridhar
Ananth Sridhar
COO of BridgeBio Cardiorenal at BridgeBio

Sure. John, thanks for the great question. On the setup in advance of our PDUFA date for encaleret ADH1, as we shared today, we see about over 2,200 patients uniquely coded under the dedicated ICD-10 code, which is E20.810 for autosomal dominant hypocalcemia. What we see is about 70 patients per month have been diagnosed and coded according to that code in the claims databases, and it is suggestive of what we would have anticipated, which is the availability of promising and positive clinical data driving awareness and suspicion to test for ADH1 in the clinic. Between now and PDUFA, as one might expect, we are investing further in raising disease state awareness, and we have our medical team meeting with institutions and providers, amplifying disease state awareness efforts and growing familiarity with our evidence. Between now and PDUFA as well, we will continue to engage with our payer audience.

Ananth Sridhar
Ananth Sridhar
COO of BridgeBio Cardiorenal at BridgeBio

To date, the interactions have been quite positive. The anticipation for a new and first modality directly targeted to treat ADH1 has been quite well received amongst the payer audience. We anticipate a constructive dialogue as we approach PDUFA more closely. To your second question regarding RECLAIM. It is a really exciting update today as we shared that screening activities have started for that phase III study. We anticipate to deliver top-line results from that study in about 18 months or so. It might be a great opportunity for us to grow the clinical utility of encaleret into the broader chronic hypoparathyroid population. We see around 200,000 individuals in the U.S. and Europe to be afflicted with chronic hypoparathyroidism. If we are successful in this indication, we see another blockbuster opportunity for us to grow into.

Operator

We'll move to our next question from Derek Archila at Wells Fargo.

Derek Archila
Derek Archila
Analyst at Wells Fargo

Hey, good afternoon. Thanks for taking the questions. Just a quick one. I know in the past you had mentioned like 30%-40% peak share for Attruby, assumed a four-player market with combo use expanding. I guess, how does the failure of CARDIO-TTRansform raise that ceiling? Just curious if you plan to update that assumption anytime soon. Thanks.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Yeah, Derek, thank you for the question. We're conducting market research, and I think that we'll probably kick it off more after the CARDIO-TTRansform results come out more fully at ESC. At that point, we can more formally talk about what we expect as peak share. I think as Neil mentioned in his prepared remarks, we do think that the case for combo therapy scientifically is quite dead now. I think that does benefit, and I think the stabilizer should also remain front line as we discussed. We expect those things to be positive, but we don't have new market research to share at this point. It would be a bit preliminary to do it before the medical conference has happened and physicians haven't had a chance to digest all of it. Really appreciate your question.

Operator

Our next question comes from Luca Issi at RBC.

Luca Issi
Luca Issi
Analyst at RBC

Oh, great. Thanks so much for taking my question. Congrats on the progress. Maybe on achondroplasia, BioMarin last week mentioned that 100 patients have switched from VOXZOGO to Yuviwel, or less than 10% of all the VOXZOGO patients. They are arguing that 10% is such a low number. This suggests that the market is very sticky and the patients are loyal to VOXZOGO. Just wondering, what is your comment on that? What is your view on that number as we think about the launch of infigratinib potentially next year? Thanks so much.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Thanks, Luca. Appreciate the question. I am going to pass it on to Justin To to talk about the infigratinib program.

Justin To
Justin To
CEO of Skeletal Dysplasias at BridgeBio

Yeah. No, thanks so much for the question. Yeah, I think we have been really pleased by what we have heard the last few weeks from both BioMarin and Ascendis. I think there is a lot of favorable tailwinds for our upcoming launch. On the BioMarin side of things, they continue to increase the treatment rate and build the market globally, really enlarging the pie for everyone across all markets. Because it is easier to get a switch than to get a patient who has never been on a treatment before. I think that has been really great to see their launch continue to accelerate there. Based on the recent Ascendis numbers, they really validated two of our key assumptions for launch. The first is that there is really not that much brand stickiness in the space. Families want their kids to switch to the most convenient option.

Justin To
Justin To
CEO of Skeletal Dysplasias at BridgeBio

When we are on the market, not only will we have the most convenient option, but by far the most efficacious. Ascendis having a strong launch here is good for us if families and HCPs think about switch and think about a new option. Ever since Ascendis' approval, we have noticed a huge uptick in outreach from HCPs. The second key assumption that Ascendis' launch validates is that having a more convenient option also expands the market. I think Ascendis is seeing a good chunk of their treatment IE scripts from families who never went on VOXZOGO, or you kind of just do some of the math based on BioMarin and Ascendis' remarks. We know from multiple analogs from prior launches that availability of the first oral tends to expand the market by 2x-3x.

Justin To
Justin To
CEO of Skeletal Dysplasias at BridgeBio

We think in totality, some of the numbers we are seeing from both BioMarin and Ascendis in their remarks is going to portend well for our launch.

Operator

Next, we will go to Jason Zemansky at Bank of America.

Jason Zemansky
Jason Zemansky
Analyst at Bank of America

Good afternoon. Congrats on the nice quarter, and thanks for squeezing us in. Beyonttra royalties just reached $15 million for the quarter, looked like they are starting to scale quickly. As encaleret for ADH1 and now infigratinib move towards their respective European decisions, how are you weighing potential partnership structures like the Beyonttra agreement versus commercializing independently ex-U.S.? Is there anything you can extrapolate from your experiences about maximizing value abroad? Thanks.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Hey, Jason. It is great to hear from you, and thank you for the question. Our framework for any partnership decision always remains, we want to do what is going to be best for patients and shareholders alike, and we want to put the asset in the hands of the person that is the best owner. I think that for these next three launches, we feel very confident about being able to commercialize them globally on our own. I think we have learned a lot from the Attruby launch, and I think we are excited to grow our footprint internationally as I think actually serving those countries and KOLs is going to help us improve our drug development engine, too. That is how we are thinking about it.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Obviously, with the fact that we have about $1.7 billion of cash on our balance sheet, we are very well capitalized to fund those launches. I think that the footprint is also going to be light as we've discussed before. I think that's how we are thinking about it today, but we're always open to interesting suggestions and ideas, and we always evaluate what is best for our shareholders and patients that we wish to serve.

Neil Kumar
Neil Kumar
CEO at BridgeBio

Well, also, it's important to control price globally in an MFN world, that's what we intend to do.

Operator

Next, we'll move to Danielle Brill at Truist Securities.

Danielle Brill
Danielle Brill
Analyst at Truist Securities

Hi, guys. Good afternoon. Thanks for the question and congrats on the really strong execution this quarter. It looks like operating loss improved roughly 20% year-over-year, despite the added investment required to support potentially three new launches over the next 12 months. As Attruby continues to scale and the portfolio transitions to a multi-product commercial business, how should investors think about incremental margins and operating leverage from here? What are the key milestones that ultimately drive BridgeBio to profitability and sustainable cash flow generation? Thank you.

Tom Trimarchi
Tom Trimarchi
President and CFO at BridgeBio

Hey, Danielle. Thanks for the question. I would say with another quarter behind us, we're increasingly confident in the evolution of the P&L towards a point where we'll start to see breakeven profitability and ultimately cash generation in the relative near term. Just to give you a sense for how we think of this, we look year-on-year, we're seeing an improvement on the operating line, which has been pretty consistent year-on-year for the last few quarters. Quarter-on-quarter, though, we're pretty much stable, and we expect to be stable on the operating line for the next several quarters before that starts to improve again towards the end of the year into next year. To break that down a bit further, you've got two pieces really driving this.

Tom Trimarchi
Tom Trimarchi
President and CFO at BridgeBio

One is Attruby, which is in basically, I would say, margin expansion mode, where Opex is relatively stable, but we're seeing obviously sales growth continue to improve the margin. That's pretty much offsetting the investment we're making into the upcoming launches. We're scaling up all the activities around field medical marketing as well as expensing pre-commercial inventory right now. As we get towards steady state on those activities towards the end of next year, we'll start to see again, a trend toward improving the operating line, ultimately breakeven on the horizon as we look into 2027.

Operator

That concludes our Q&A session. I will now turn the conference back over to Chinmay for closing remarks.

Chinmay Shukla
Chinmay Shukla
SVP of Strategic Finance at BridgeBio

Thank you, everyone, for joining us for our second quarter earnings call today. We appreciate your interest, and we look forward to seeing many of you at our Commercial Day in New York on October 8, where we will go deeper on commercial readiness and launch strategy across our three upcoming launches. Thank you.

Operator

This concludes today's conference call. Thank you for your participation. You may now disconnect.

Executives
Analysts
    • Chinmay Shukla
      SVP of Strategic Finance at BridgeBio
    • Matt Outten
      Chief Commercial Officer at BridgeBio
    • Tom Trimarchi
      President and CFO at BridgeBio
    • Tyler Van Buren
      Analyst at TD Cowen
    • Cory Kasimov
      Analyst at Evercore ISI
    • Ellie Merle
      Analyst at Barclays
    • Salim Syed
      Analyst at Mizuho
    • Andrew Tsai
      Analyst at Jefferies
    • Anupam Rama
      Analyst at JPMorgan
    • Christina Xu
      Senior Associate of Strategic Finance and Operations at BridgeBio
    • John Boyle
      Analyst at William Blair
    • Ananth Sridhar
      COO of BridgeBio Cardiorenal at BridgeBio
    • Derek Archila
      Analyst at Wells Fargo
    • Luca Issi
      Analyst at RBC
    • Justin To
      CEO of Skeletal Dysplasias at BridgeBio
    • Jason Zemansky
      Analyst at Bank of America
    • Danielle Brill
      Analyst at Truist Securities
Powered by Quartr