BBIO

Image source: The Motley Fool. Monday, Aug. 10, 2026 at 4:30 p.m. ET Senior Vice President, Strategic Finance-Chinmay Shukla Chief Executive Officer-Neil Kumar Chief Commercial Officer-Matthew Outten President and Chief Financial Officer-Thomas Trimarchi Lead, Encaleret Program-Ananth Sridhar Lead, BBP-418 Program-Christine Siu Lead, Infigratinib Program-Justin To 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. 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 and uncertainties, which could cause actual results to differ materially from those expressed or implied in these forward looking statements. For a discussion of these risks and uncertainties, please refer to the disclosure in today's earnings release and BridgeBio's periodic reports and SEC filings. All statements made here are based on information available to BridgeBio as of today and the company undertakes no obligation to update any forward looking statements made during this call except as required by law. With that completed, BridgeBio, you may begin your conference. Chinmay Shukla: Good afternoon, everyone, and thank you for joining BridgeBio Pharma's second quarter 2026 earnings call. I'm Chinmay Shukla, senior vice president, strategic finance. With me today are Neil Kumar, our CEO who'll walk through our commercial pipeline and business updates, Matt Outten, our chief commercial officer, who'll provide additional detail on our 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, 2026. And we will review our financial position including the $1 billion preferred equity financing completed on July 1, 2026, 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, Christine Siu and Justin To, who lead our programs with encaleret, BBP-418, and infigratinib, respectively. 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. In sessions past, we've had occasion to marry comments on the portfolio with comments regarding financing and strategy. Today, however, I wanna 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. 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 6- to 9-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/R9, ADH1, and achondroplasia have been submitted. With LGMD2I/R9 and ADH1 garnering priority review and are hoping that achondroplasia might too. Our commercial readiness work is on track, even ahead of what we were able to do ATTR cardiomyopathy, given our relatively lean resourcing at the time. To deliver strong launches, Third, our chronic hypoparathyroid Phase 3, 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 this space. Finally, we anticipate novel trials in areas like Turner and hypochondroplasia for infigratinib, a new trial in a to be disclosed high proteinuria orphan kidney disease for acoramidis, and the advancement of a potentially best in class TTR antibody into the clinic in coming 12 to 18 months. All of this activity together provides the substrate for well over $10 billion in risk adjusted revenue with $8 billion of that being post Phase 3 today. In addition, our interest in earlier but still advanced genetic medicine R and D within our GondolaBio 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 cardiac 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. To that end, we were heartened 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 to 3 percentage points although it's hard to tell precisely given some of the inventory dynamics from our competitor, Pfizer. Our gross to net also remains within the 30% to 40% that we have indicated previously. 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 is 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. 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 down benefit. More specifically, comparing acoramidis versus placebo subgroups with acute eGFR dips greater than or equal to the median of 4.89 mL/min/1.73 m² 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. The observed effect compares favorably to what we see 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 have a kidney drug here. Building on that, as referred to above, we intend to further interrogate the 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 match analysis presented at SCAI since published, which continues to resonate with physicians. That analysis associated Attruby with a 37% reduction in composite cardiovascular events and a 34% reduction in hospitalizations at 6 months. Relative to tafamidis, with an effect deepening at 9 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 p<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. 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 that 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 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 of eplontersen in ATTR cardiomyopathy read out, and the study did not meet 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. The case for combination therapy seems today null from a trial data perspective. Given the similar degrees of knockdown between eplontersen and vutrisiran, we'll 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 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. And if the monotherapy benefit, again, lags in time, this is a 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'd 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/R9 program, the FDA accepted our NDA on May 27, 2026, with priority review. PDUFA date is November 27, 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 will be the first approved therapy for LGMD2I/R9, a devastating condition affecting a little more than 1,000 patients in The US alone with significant unmet need. There's 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'll 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 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. 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'll 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 preapproval information exchange. There are approximately 500 genetically confirmed patients today in The United States, with many who remain unidentified and misclassified within the broader LGMD or Becker muscular dystrophy space. Our goal is to find every patient who can benefit and be ready the moment we're able to reach them. Turning to encaleret for ADH1, FDA accepted our NDA on July 22, 2026, with a PDUFA target action date of May 8, 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 27, 2026, and it is under review. encaleret would be the first therapy approved for ADH1 in both The United States 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, That is an increase of about 300 since the first quarter, it's been driven by genetic testing, awareness education, use of the ICD-10 code, 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. But ADH1 approval is the beginning of encaleret's potential, not the end. Chronic hypoparathyroidism affects some 200,000 patients in The US 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's been overlooked significantly by investors. First, there may be a belief that PTH replacement is the beginning and end of the game here. With advances around dosing, for instance, going from daily to weekly, being the only salient dynamic for patients. But 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 chronic hypoparathyroidism patients, actually being hypercalcicuric. Two, there's 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. And 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. Recall first that the hypercalciuria in chronic hypoparathyroidism 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. And 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-16/19 complex which acts as a calciuria promoting pore blocking component. This mechanistic rationale helps to explain the observation from our proof of concept Phase 2 where 80% of postsurgical hypoparathyroidism patients administered with encaleret achieved both normal blood and urine calcium within 5 days. 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. But 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. And 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've seen and know and the stability of those endpoints statistically, that we have a high probability of technical success trial on our hands. 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. And as mentioned in our press release, we have already activated our first site for the RECLAIM trial, our global Phase 3. Have begun screening with FPI 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 3 PROPEL 3 results at the International Congress of Children's Bone Health on June 28. And simultaneously published them in the New England Journal of Medicine. The only achondroplasia program with Phase 3 results in the New England Journal. Following that publication, I'm excited to announce we submitted our NDA, and we are targeting an MAA submission in Q4 of this year. We hope to see NDA acceptance and ideally priority review in Q4 2026 with approval following in mid-2027. Approval would make infigratinib the first FGFR3 targeted oral therapeutic for achondroplasia. And 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 clean functional differentiator in our Phase 3 results with a statistically significant 0.37 standard deviation improvement on arm span with a p value of <0.0001. This is the first ever placebo controlled arm span benefit an achondroplasia trial. We look forward to presenting more data in the second half of this year and continuing to build infigratinib's scientific story through the preapproval period. 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 team. For meaningful share of voice in a market where two competitors are already present, and where we see a real gap especially in The US, 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 2a data in June. And following a productive End-of-Phase-2 meeting with the agency, we would be initiating a Phase 2b/3 study in Q3 of this year. Critically, given the over 80% magnitude of PPIX reduction with the quick onset of action and safety profile, the agency suggested that the Phase 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-one antitrypsin, neurofibromatosis type 1, and CMT1A. In total, the activity has potential to yield 5 additional INDs by the end of this year, with some 8 clinical proof-of-concept readouts to come in the 2027-2028 time frame. Of course, despite all of this, we continue to stay focused on delivering our important medicines to patients in the commercial setting. And for more information on that, I'll pass it over to Matt. Matthew Outten: 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 wanna spend a moment on the composition of that growth. Because that is the part that matters most 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. 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. So 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. And because much of that work was conducted independently of us, it carries the 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 block status in 2026. And we remain on track for that. 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 United States. It is not a forecast for The US Attruby net product revenue. For the balance of my time, I wanna 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. 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 9 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. We are also engaged with payers, through preapproval 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, 2027. And no advisory committee meetings 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. If approved, it would be the first therapy specifically indicated for adult and adolescent patients with ADH1. As with BBP-418, are engaged early with payers. So that the clinical rationale is well understood before a decision. Third, infigratinib and achondroplasia. We have submitted the NDA, and we anticipate approval in mid-2027. Unlike the other two launches, infigratinib enters the 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. 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 prespecified 3- to 8-year-old subgroup. Operationally, our commercial infrastructure continues to build. 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. Our partnership with the achondroplasia community over the past 7 years is under how we are approaching this launch. In short, are on track across all three programs. With that, I'll turn the call over to Tom. Thank you, Matt. Thomas Trimarchi: Good afternoon, everyone. I'll 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 $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. License and services revenue was $5.8 million compared to $37.4 million in the same period last year, which included a onetime $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 the Attruby preparations for three upcoming launches. It 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. As of June 30, 2026, our cash, cash equivalents, and marketable securities $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. Our cash balance at approximately $1.7 billion as of July 1, 2026. We believe our current cash position provides us with 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'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: 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 1 on If you would like to withdraw your question, simply press 1 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: Hey, guys. Good evening, and congratulations on another strong quarter. It's great to see the more than 35,000,000 sequential U. S. Revenue that Attruby added again this quarter. But as the release specifically calls out Attruby growth led by the treatment naive, segment as physicians increasingly start and keep patients on Atrubi, Can you discuss what is driving that consistency in the first line And perhaps most importantly, given competitive developments, why those drivers are durable? And perhaps could also layer that in with expectations for the potential impact that the CARDIO-TTRansform failure and upcoming data ESC could have on Attrubyus treatment naive share as well. Chinmay Shukla: I'm sorry. I'm gonna pass on to Matt. To comment on some of the commercial dynamics, and then I'll I'll pass on to Neil if he wants to add things on CARDIO-TTRansform expectations at ERC. Matthew Outten: 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, And 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 And this is going to add on to the earlier messaging and continue to push share forward in the future. And I'll let Neil add on with the CARDIO-TTRansform hubs. Neil Kumar: Yeah. Thanks, Tyler. I guess I'd just say, I mean, 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, you know, to Matt's point, we'll continue to differentiate and I think we're gonna see the fruit that I as I mentioned in my comments, of the real world evidence, kidney differentiation, up here, really, by kinda, like, half a year from now or so. If you 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 of the independent RWE analysis, but it everything continues to go the way of Attruby. I mean, you know, as you well know, it's sort of like yeah, as you start to as you start to connect all the dots from biochemistry to serum TTR, I mean, 1 mg/dL is a 5% decrease in mortality risk in 30 months. To, you know, all of the real world evidence against both survival. At least we'll see that at HFSA. And we saw some hints of that with the and independent more data around it. Time that we launched. Hospitalization and ODI as we mentioned today. I think all of that comes together to say, we have a superior stabilizer, and that's really the message we gotta continue to hit. I mean, my expectation would be that we really hit a positive second derivative here and continue to grow pretty aggressively in the frontline over the coming 12 to 18 months. So let's see. Operator: We'll go next to Cory Kasimov at Evercore ISI. Cory Kasimov: Hey. Good afternoon. Thanks for taking my question. Perhaps not surprisingly, I also wanna ask a question regarding CARDIO-TTRansform. Missing the primary endpoint. So know, at this point, we obviously know there was substantial background stabilizer use. And putting the silencer on top of it didn't improve outcomes. So I know you touched on some of this in your prepared remarks, but in your view, does this not only cement stabilizers kind of the first line backbone here in future treatments? 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: Yeah. Thanks for the question. I Maybe I'll start, and, Matt, you can add on. You know, I'd say it's a little early for us to get feedback from payers. On the KOL side, for sure, I mean, we've been hearing I think, a bit of surprise, honestly. And you know, 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. So do think Stabilizer will be an increasing increasingly large part They already are a large part, but an increasing large part of the frontline, and I think that's where the real action will be in this category. I'd say, you know, the three things that we're looking for with regard to CARDIO-TTRansform, I do think of eplontersen and vutrisiran have a very similar knockdown profile. We have to look at 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. And then within the context of the clinical data, you know, first and foremost, what's the thirty month data look like? Is anyone getting to three forty two fifty? And 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 you, you know, that basically Attruby will look superior at 30 months 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 and the early onset now well described by this kidney data that we put out and will continue to elaborate on I think the second super intriguing point will be to see whether or not monotherapy knockdown actually outperforms a partial stabilized You know, people sometimes know you and I have chatted about this, but, you know, people sometimes forget that in HELIOS-B, and that would tell us that all Jack favor that we 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. And I hear again, if eplontersen doesn't out outperform a partial stabilizer, recall, we've had a stabilizer to outperform tafamidis in every single part of the ATTRibute-CM trial that we looked at. In all major RWE studies And so, again, starts to establish, I think, Attruby is a superior efficacious agent as compared to both knockdowns and the partial stabilizer. Of Pfizer. So this will be the second big thing we're looking for Yeah. Is anything else you'd add? No. I mean, I've Matthew Outten: well said. I think we're interested in seeing the full data set at ESC, but certainly the results don't appear to support combination therapy. Which just then reinforces stabilization of the backbone of therapy. And, again, your comments, I think, on the partial stabilizer versus a near complete stabilizer, that's kind of kind of where we are, and I don't think anything would see it. ESC is gonna change that based on the initial results that were posted. Operator: We'll go next to Eliana Merle at Barclays. Eliana Merle: Guys. Thanks for taking the question, and congrats on all the progress. So the Pfizer release cited net price erosion from new payer contracts. While your gross to net has remained stable within the range you 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 a own? Thanks. Neil Kumar: Yeah. Thanks, Ali. It's an important question. I mean, I think we'd like clinical differentiation to continue to carry the day here. We there's no way that we could respond and meet Pfizer's rebates if they're gonna be aggressive and 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. And here's where the real world evidence really comes in handy. I mean, a 35% or 34% in an independent study reduction in hospitalizations as compared to tafamidis that's super meaningful. These are patients that are quite sick, quite expensive. And there's some unworthiness that can also happen when you favor one brand over the other. So I think long term, these brands will be a parity generally in terms of access. I think clinical differentiation will be where we where we win. So 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: 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. So, you know, obviously, you know, the better stabilizer, everybody knows that. All the real world the real world curves show that also Attruby is better than tafamidis. Just wondering how this adds into sort of 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, choosing a stabilizer, we kinda, like, drag that forward a little bit with the list price already being below TAF, what does this eventually mean for Attruby the market evolves and when tafamidis goes generic? Chinmay Shukla: Yeah. Salim, thanks for the question. I'm gonna let Matt handle all the data that's being received by KOLs, and then I'll send the back on Matthew Outten: the generic question. But not currently talk about differentiation on the kidney data. Yeah. I mean, I think first thing to note, this is new. So up to this point, it's been about the three forty two fifty as Neil mentioned. It's 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, So that's what's led us Through Q2. I think in terms of the kidney data, it's very important to physicians and you're 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 hasn't been out. It's it's brand new. So you're gonna see that impact now as we move forward over the next couple of quarters. Chinmay Shukla: Yeah. And just to but on that we might have discussed this. I'll I'll I'll I'll leave But on this, but we do expect the brand to keep growing even after Vyndamax goes generic. In mid-2031 in The US. And, really, there are five reasons for it. Right? I think the first is to be exponentially differentiated. You've heard a lot about that on the call today. That is driving the strength and treatment manual for us, and I think from the keep driving strength there. The second, which I think is less understood by folks is that stakeholder economics in this market, the SPs, they don't largely support a preference for genetics. And you can also see that Pfizer's been successful in the finding other franchises. And I think that there's a potential for some upside because if Pfizer stops promoting post ROE, that would increase relative share of voice for Attruby. If you look at all of this, and you look at all the analysis on analogs, which I know you and Ben and have done a retile on it. I think that we expect that even as opposed to market, less potent stabilized approach to net, a near complete stabilized and actually, we can't keep growing Neil Kumar: So can I just build on one point that Matt made? Because I think the kidney data is super fresh. So we're, you know, we're gonna have to see in the next six to nine months kinda how it changes prescribing behavior. But first and foremost, I think it's important because the actual mechanism of turning down toxic monomer, you wouldn't expect to pick up impact as early as 28 days or 1 month. So if you're now, you have a viable mechanism by which you have this early onset of efficacy And, you know, as I mentioned in my in my remarks where I hinted at, like, 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 cardiovascular hospitalization. And death. So that's also a profound suggestion here. That I that I think will be very important on a go forward basis. And you we gotta remember, like, 50% of the patients close to 50% of patients with ATTR cardiomyopathy have some sort of kidney involvement. So this is an important this protective signature is gonna be an important piece, we believe, of the emerging story here, you know, and potentially an interesting piece of 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: Congrats on the solid execution. So 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 5 months of the top line, two priority reviews, no adcoms planned. So 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 feel feeling about the review timelines from here. I'd also be curious about your ex US. Interactions too. Thank you. Neil Kumar: Sure. I'm I'm happy to take that. I mean, I think first and foremost, as you probably know in the in the rare disease setting, I think the gold standard is the ability to run an RCT a solid RCT with a placebo arm. We've been able to do that across all three indications here. And demonstrate profound functional benefits. So you know, I think one of the one of the senior administrators at the agency once said that we're kind of the poster child of what one tries to do at least in the rare disease setting. It's not obviously always gonna be the case. For instance, in, Kanavan 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. I mean, you know, people forget that with these small molecules, we've been able to provide an exquisite safety profile. So the risk benefit is pretty straightforward as well. So, yeah, based on all of that, we've we've had productive discussions with the agency to date, and, you know, we look forward to putting into engage them on that front. And similarly, I'd say, in Europe as well, there hasn't been a dichotomy between tenor of our conversations there yet. Operator: Our next question comes from Anupam Rama at JPM. Anupam Rama: Hey, guys. Thanks so much for taking the question. I'm just thinking a little bit about, the November 27, 2026, PDUFA for BBP-418 in limb girdle muscular dystrophy. Sounds like you guys have made a lot of progress here on the field team, the neuro 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: Yeah. Thanks, Anupam. We're gonna pass on Christine to talk about the BBP-418 launch. Christine Siu: Hi, Anupam. Just as a reminder, this is a opportunity where we think it's a $1 billion peak sales opportunity. We think there's 7,000 patients in The US and EU with 2,000 to 3,000 in The US. In The US, 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. So as we mentioned, we do have a dedicated sales force that's been fully hired if trained in the field now. Really focused on disease 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 awareness and increasing the awareness of genetic testing. And that's been key for driving increasing patient ID and genetic testing. On the patient side of things, we have identified over 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 9 months, and that is a that is key to increasing the number 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, that's also gonna help with tracking patients and just greater visibility as we commercialize BBP-418. On 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. They've been quite receptive to the strength of our data and the unmet need on the patient side. They view the closest price analog as the exon skipping D and D drug. As a comparable patient population for them. And I guess the ones having here they even acknowledge that we have much stronger data because we actually have the function data. It's not the base of biomarkers. And so that's an area of strength for us to launch. Operator: We'll go next to John Boyle at William Blair. John Boyle: Congrats on the strong quarter, and thanks for taking our question. So I wanted to ask on encaleret. Now that you have priority review, the MAA is submitted and diagnoses are increasing with each month with the ICD-10 code, Wondering if you could walk us through the launch setup into the May 2027 PDUFA date. And 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're viewing it as the next leg of growth for the franchise. Thanks. Chinmay Shukla: Thanks, John. Really appreciate your question. Gonna pass on to Ananth to talk about encaleret. Ananth Sridhar: Sure. John, thanks for the great question. On the on the setup in advance of our PDUFA date for encaleret in 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, it's 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, And between now and PDUFA, as one way expect, we're investing further in raising disease state awareness and have our medical team meeting with institutions and providers amplifying disease state awareness efforts, and growing familiarity with our evidence. And between now and PDUFA as well, we will continue to engage with our payer audience to date. The quite positive. The anticipation for a new in first modality directly targeted to treat ADH1 has been quite well received among the payer audience, we anticipate constructive dialogue as we approach people more closely. And then to your second question regarding reclaim, it's a really exciting update today as we shared that screening activities have started for that Phase 3 study. We anticipate to deliver top line results from that study in about 18 months or so. And 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 US and Europe be afflicted with chronic hypoparathyroidism If we're 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: Hey, good afternoon. Thanks for taking the questions. Just a quick one. So know in the past, you had mentioned like 30% to 40% peak share for Attruby assumed a four-player market with combo use expanding. So I guess, how does the failure of CARDIO-TTRansform raise that ceiling? And just curious if you plan to update that assumption anytime soon. Chinmay Shukla: Yeah. Thank you for the question. We're conducting research, and I think that we'll probably keep it off more after the CARDIO-TTRansform results come out more fully at ESC. And so at that point, we can more formally talk about what we expect to feature. I think as Neil mentioned in his prepared remarks, we do think that the case for combo therapy scientifically is quite dead now, and so I think that does benefit and I think the stabilizer shows the main front line as we just got. So 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 have a chance today to solve it. Really appreciate your question. Operator: Our next question comes from Luca Issi at RBC. Luca Issi: Great. Congrats on the progress. Maybe on achondroplasia, you know, obviously, BioMarin last week mentioned that 100 patients have switched from Voxzogo to YUVIWEL or less than 10% of all the Voxzogo patients. You know, they're obviously arguing that 10% such a low number to suggest that the market is very sticky and the patients are loyal to Voxzogo and know, so just kinda wondering what's your comment on that? What's your view on that number as we kinda think about the launch of infigratinib potentially next year? Thanks so much. Chinmay Shukla: Thanks, Luca. Appreciate the question. I'm gonna pass on to Justin talk about the infigratinib program. Justin To: Yeah. No. Thanks so much for the question. I think we've been really pleased by what we've heard the last few weeks from both BioMarin and Ascendis. I think there's a lot of favorable tailwinds for our upcoming launch. Now on the side of things, they continue to increase the treatment rate and build the market globally, really enlarging the pie for everyone. Across all markets. You know, because it's easier to get a get a switch than to get a patient who's never been on treatment before. Mean, that's been really great to see if they're launching a change already there. Now based on the recent Ascendis numbers, it really validates two of our key assumptions for launch. The first is that there's really not that much brand stickiness. Space. Families want their kids to switch the notion of being an option. And when we're on the market, not only will we have the notion of being an option, but by far the most efficacious. And so Ascendis having a strong launch here is good for us. If families and HCPs think about which think about new options. And ever since Ascendis's approval, we've noticed a huge uptick in outreach of ACT. Now the second key assumption that Ascendis's launch validates is that having a more convenient option will help expand the market Now I think that is being a good chunk of their treatment. I use scripts. From families who never won Voxzogo really. You kinda do some of the math based on that it's Mars. And we know from multiple analogs, from prior launches that the availability of the first oral tends to expand the market by two or three times. So we think in totality, some of the numbers we're seeing from BioMarin and Ascendis in their remarks is gonna be for our launch. Operator: Next, we'll go to Jason Zemansky at Bank of America. Jason Zemansky: Good afternoon. Congrats on the nice quarter, and thanks for squeezing us in. BEYONTTRA royalties just reached $15 million for the quarter. It looks like they're starting to scale quickly. So as encaleret, BBP-418, and now infigratinib have moved toward their respective European decisions, How are you weighing potential partnership structures like the BEYONTTRA agreement? Versus commercializing independently, ex US? And mean, is there anything you can extrapolate from your experiences about maximizing value abroad? Thanks. Chinmay Shukla: Hey, Jason. It's it's great from 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. We want to put the asset in the hands of the person that is the best owner. I think that we think for these next three launches, we feel very confident about being able to commercialize them globally on our own. I think we've learned a lot from the Attruby launch. And I think we're excited to grow our footprint internationally. Because I think actually serving those countries and KOLs is going to help us improve our development engine too. So that's how we are thinking about it. Obviously, with the fact that we have both $1.7 billion of cash on our balance sheet, we're very well capitalized. To fund those launches, and I think that the footprint is also going to be light as we've discussed before. So I think that's how we are thinking about it today, but, you know, we're always open to suggestions and ideas, and all we always evaluate is what is best for our shareholders and patients that we wish to serve. Neil Kumar: Well, also, as a important to your control price? Globally. In an MFN world. So that's what we intend to do. Operator: And next, we'll move to Danielle Brill at Truist Securities. Danielle Brill Bongero: Hi, guys. Good afternoon. Thanks for the question, and congrats on the really strong execution this quarter. So 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, So as Attruby continues to scale and the portfolio transitions to a multiproduct commercial business, how should investors think about incremental margins and operating leverage from here? What are the key milestones that ultimately drive Bridge to profitability and sustainable cash flow generation. Thank you. Thomas Trimarchi: Hey, Danielle. Thanks for the question. So I would say with another quarter behind us, we are increasingly confident in the evolution of the p and l toward a point where we'll start to see breakeven profitability and, ultimately, cash generation in the in the relative near term. Just to give you a sense for how we think of this. So 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. On quarter, though, we're we're pretty much stable. We expect to be stable on the operating lines for the several quarters before that starts to improve again. The end of the year into next year. To break this down a bit further, you've got two pieces really driving this. 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. So we're scaling up all the activities around field medical marketing as well as expensing precommercial inventory right now. So as we get to toward steady state on those activities toward the end of next year, we'll start to see, again, a trend toward improving the operating line. Ultimate breakeven on a on the on the horizon as we look into 2027. Operator: And that concludes our Q&A session. I will now turn the call back over to Chinmay for closing remarks. Chinmay Shukla: 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: And this concludes today's conference call. Thank you for your participation. You may now disconnect. Before you buy stock in BridgeBio Pharma, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and BridgeBio Pharma wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool recommends BridgeBio Pharma. The Motley Fool has a disclosure policy. BridgeBio (BBIO) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Total Revenues: $243.7 million for Q2 2026, compared to $110.6 million in Q2 2025. Attruby Net Product Revenue: $222.4 million, up from $71.5 million in the same period last year. Royalty Revenue: Increased to $15.4 million from $1.6 million year-over-year, primarily from Beyonttra sales in the EU and Japan. License and Services Revenue: $5.8 million, compared to $37.4 million in Q2 2025, which included a one-time $30 million regulatory milestone. Total Operating Expenses: $335.7 million for Q2 2026, up from $241.2 million in Q2 2025. Loss from Operations: $107.1 million in Q2 2026, an improvement from a $134.3 million loss in Q2 2025. Cash Position: $720.2 million in cash, equivalents, and marketable securities as of June 30, 2026; approximately $1.7 billion after closing a $1 billion preferred equity financing on July 1, 2026. Warning! GuruFocus has detected 8 Warning Signs with BBIO. Is BBIO fairly valued? Test your thesis with our free DCF calculator. Release Date: August 10, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Attruby continues to show strong commercial momentum, with Q2 2026 net product revenue of $222.4 million, a $35 million+ sequential increase, and the brand being the fastest-growing in the ATTR-CM space at 23%. New data from the Circulation: Heart Failure publication demonstrates Attruby's first-ever early and sustained direct kidney protective effects in ATTR-CM, including improved eGFR slope and reduced albuminuria, which could differentiate it from competitors. All three late-stage pipeline programs (BBP-418 for LGMD2I, encaleret for ADH1, and infigratinib for achondroplasia) have had their NDAs accepted by the FDA, with BBP-418 and encaleret receiving priority review and no advisory committee meetings planned. The failure of CARDIO-TTRansform, which studied eplontersen in combination with stabilizers, reinforces the case for stabilizer-first therapy, potentially benefiting Attruby's market position as the only near-complete stabilizer. The company closed a $1 billion preferred equity financing on July 1, 2026, bringing cash to approximately $1.7 billion, providing a strong runway to fund three upcoming launches and ongoing operations. Encaleret's potential is expanding beyond ADH1, with the RECLAIM-HP phase III trial in chronic hypoparathyroidism now screening, targeting a 200,000-patient market in the US and EU, which could be a blockbuster opportunity. Infigratinib's phase III PROPEL 3 results, published in NEJM, show the first-ever placebo-controlled arm span benefit in achondroplasia, and the oral dosing advantage could expand the market, with peak share potential above 65%. The company's financial position is improving, with operating loss narrowing by 20% year-over-year, and management expects to reach breakeven profitability by 2027. Real-world evidence, including an independent propensity score-matched analysis, shows Attruby associated with a 37% reduction in composite cardiovascular events and 34% reduction in hospitalizations versus tafamidis, with no outcome favoring the competitor. The company's commercial readiness for upcoming launches is ahead of schedule, with field teams hired and trained, and payer engagement underway for BBP-418, encaleret, and infigratinib. The CARDIO-TTRansform trial failure is a setback for the ATTR-CM community, and while it may benefit stabilizers, it also highlights the uncertainty in the competitive landscape, with potential for knockdown therapies to still compete in the future. Attruby's second-line or switch segment is settling into a lower, normalized steady state, with the forced Vyndaqel switching pool largely worked through, which could limit near-term growth from that segment. The company faces intense competition in the first-line ATTR-CM market, with Pfizer's tafamidis and other players, and management acknowledges the need to keep earning share quarter by quarter. Operating expenses increased significantly, up $94.5 million year-over-year, driven by investments in Attruby and launch preparations, which could pressure margins in the near term. The company's guidance for Attruby to reach blockbuster status in 2026 is based on worldwide sales including partner-recorded Beyonttra, not just US net product revenue, which may not meet investor expectations for US-only growth. There is uncertainty regarding the impact of the kidney protection data on prescribing behavior, with management noting it will take six to nine months to see commercial fruit, indicating a lag in realizing benefits. The company has not updated its peak share assumptions for Attruby following CARDIO-TTRansform, and management is waiting for more data from ESC and market research, leaving investors without clear guidance on upside. Infigratinib enters a market with established competitors (BioMarin's VOXZOGO and Ascendis's UVOOWL), and while the oral advantage is a differentiator, the market may be sticky, as evidenced by BioMarin's claim of only 10% switching from VOXZOGO. The company's reliance on real-world evidence and independent analyses, while growing, may not be sufficient to sway all physicians and payers, especially as tafamidis approaches generic entry in 2031, which could alter market dynamics. The company's financial runway, while strong, is dependent on successful execution of multiple launches and continued Attruby growth, and any delays or setbacks could strain cash resources. Q: Given the failure of CARDIO-TTRansform, does this cement stabilizers as the first-line backbone, and what feedback have you received from KOLs and payers regarding the evolution of combination therapy prescribing and reimbursement?A: Neil Kumar (CEO) stated it is too early for payer feedback, but KOLs have expressed surprise, and the trial likely reinforces stabilizers as the frontline standard. He highlighted three key points to watch: whether eplontersen's knockdown profile matches vutrisiran's, whether monotherapy knockdown outperforms a partial stabilizer (noting vutrisiran didn't significantly outperform tafamidis in HELIOS-B), and the potential for Attruby's superior efficacy and early separation to strengthen its case in the switch setting. Matt Alten (CCO) added that the results don't support combination therapy, reinforcing stabilization as the backbone, and Attruby's position as the only near-complete stabilizer. Q: What is driving the consistent growth in the treatment-naive segment for Attruby, and how durable are these drivers given competitive developments and the upcoming ESC data?A: Matt Alten (CCO) attributed the growth to Attruby's rapid separation from placebo and significant hospitalization reductions, which are now supplemented by new real-world evidence, kidney data, and CARDIO-TTRansform results. Neil Kumar (CEO) added that the stabilizer frontline market should expand following CARDIO-TTRansform, and he expects the real-world evidence and kidney differentiation to drive a positive second derivative in growth over the next 12-18 months, with effects materializing in six to nine months. Q: How important is the kidney protection data from the Circulation: Heart Failure publication in physician prescribing decisions, and what does it mean for Attruby as the market evolves and tafamidis goes generic?A: Matt Alten (CCO) noted the kidney data is new and very important to physicians, with its impact expected to grow over the coming quarters. Chinmay Shukla (SVP, Strategic Finance) added that Attruby should keep growing even after Vyndaqel goes generic in mid-2031 due to clinical differentiation, stakeholder economics that don't favor generics, and potential increased share of voice if Pfizer stops promoting. Neil Kumar (CEO) highlighted that the kidney data provides a mechanism for early efficacy onset, and with nearly 50% of ATTR-CM patients having kidney involvement, this protective signature is a key differentiator. Q: With the Pfizer release citing net price erosion from new payer contracts, does BridgeBio see a need to respond on price, or is clinical differentiation carrying access and share?A: Neil Kumar (CEO) stated BridgeBio will not chase Pfizer's aggressive rebates, relying instead on clinical differentiation, particularly the 34-37% reduction in hospitalizations from real-world evidence. He expects brands to reach parity in access long-term, with clinical differentiation being the deciding factor, and the company will not engage in near-term price dynamics. Q: Can you walk us through the launch readiness for BBP-418 ahead of the November 27 PDUFA, and how you plan to identify more patients beyond the 500 genetically confirmed?A: Christine Xu (Senior Associate, Strategic Finance & Operations) detailed that the sales force and MSLs are fully hired, trained, and in the field focusing on disease state awareness and genetic testing. The company has identified over 1,500 genetically confirmed patients, with genetic testing rates increasing. A new dedicated ICD-10 code for LGMD2I/R9 will aid patient tracking. Payer feedback has been positive, with payers viewing the data as stronger than exon-skipping DMD drugs due to functional outcomes. Q: What is the launch setup for encaleret into the May 2027 PDUFA date, and how do you view the RECLAIM-HP opportunity as the next growth leg?A: Ananth Sridhar (CEO, BridgeBio Endocrinology) noted over 2,200 patients have been identified under the ICD-10 code, with about 70 new patients per month. The company is investing in disease state awareness and payer engagement, which has been positive. For RECLAIM-HP, screening has started, with top-line results expected in about 18 months. The chronic hypoparathyroidism market includes around 200,000 patients in the US and Europe, representing a potential blockbuster opportunity. Q: How does the failure of CARDIO-TTRansform raise the peak share ceiling for Attruby, and do you plan to update your assumptions?A: Chinmay Shukla (SVP, Strategic Finance) stated that market research will be conducted after the full CARDIO-TTRansform results are presented at ESC. He noted the case for combination therapy is scientifically dead, which benefits stabilizers, but it would be premature to update peak share assumptions before physicians have digested the data. Q: BioMarin mentioned only 100 patients switched from VOXZOGO to UVOOWL, suggesting market stickiness. What is your view on this as you prepare for infigratinib's launch?A: Justin To (Program Lead, infigratinib) expressed optimism, noting BioMarin's launch is enlarging the market. Ascendis's launch validated two key assumptions: there is not much brand stickiness, as families want convenient options, and a more convenient option expands the market. He noted a huge uptick in HCP outreach since Ascendis's approval, and analogs suggest the first oral option can expand the market 2-3 times. Q: With Beyonttra royalties reaching $15 million, how are you weighing partnership structures versus independent commercialization for encaleret and infigratinib ex-US?A: Chinmay Shukla (SVP, Strategic Finance) stated the framework is to put assets in the hands of the best owner. For the next three launches, BridgeBio is confident in commercializing globally on its own, leveraging learnings from Attruby and its $1.7 billion cash position. Neil Kumar (CEO) added that controlling price globally in an MFN world is important. Q: How should investors think about incremental margins and operating leverage as Attruby scales and the portfolio transitions to a multi-product commercial business?A: Thomas Trimarchi (President, CFO) noted the operating line improved ~20% year-over-year, with stability expected for the next several quarters before For the complete transcript of the earnings call, please refer to the full earnings call transcript.

BridgeBio Pharma BBIO reported a second-quarter 2026 loss of 78 cents per share, wider than the Zacks Consensus Estimate of a loss of 64 cents. Despite the miss, the figure improved compared to the year-ago loss of 95 cents. Revenues surged 120% year over year to $243.7 million, beating the Zacks Consensus Estimate of $222.6 million. This growth was primarily driven by its sole marketed drug, Attruby. Year to date, BridgeBio’s shares have gained 11% compared with the industry’s 7% growth. Image Source: Zacks Investment Research Attruby, which is approved for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM), generated $222.4 million from product sales in the United States. The figure more than tripled from the $71.5 million recorded in the year-ago period. Per BridgeBio, Attruby continued to gain share among treatment-naive patients, which management views as the key long-term growth driver for the franchise. Meanwhile, the pool of patients switching from Pfizer’s PFE Vyndaqel/Vyndamax, a key competing ATTR-CM therapy, has begun to normalize after elevated switching activity in prior quarters. Management expects continued first-line share gains to support sales growth going forward. Royalty revenues increased to $15.4 million from $1.6 million, primarily reflecting Attruby sales in the EU and Japan, where it is marketed as Beyonttra. License and services revenues fell 84% year over year to $5.8 million, as the prior-year period benefited from a $30 million regulatory milestone. Research and development expenses increased 34% year over year to $149.4 million, reflecting continued investment in late-stage programs. Selling, general and administrative expenses climbed 44% to $186.3 million as the company supported Attruby commercialization and pre-commercial work for upcoming launches. As of June 30, 2026, cash, cash equivalents and marketable securities totaled $720.2 million, down from $940.2 million in the previous quarter. The figure excludes the $1 billion preferred equity financing that closed July 1, which lifted the company's cash balance to about $1.7 billion. Alongside the earnings results, BridgeBio announced that it has submitted a regulatory filing with the FDA for oral infigratinib in achondroplasia. If approved, the company expects a commercial launch in mid-2027. This marks the third regulatory filing submitted to the FDA. BridgeBio already has two filings under review — BBP-418 for limb-girdle muscular dystrophy (LGMD) type 2I/R9 (LGMD2I/R9) and encaleret for autosomal dominant hypocalcemia type 1 (ADH1). A final decision on BBP-418 is expected by Nov. 27, 2026, and on encaleret by May 8, 2027. Commercial and medical teams are being built across the programs. More than 2,200 ADH patients had been identified under the dedicated ICD-10 code through June 2026, with about 70 new diagnoses per month. Beyond ADH1, the company has begun screening patients in the phase III RECLAIM-HP study on encaleret for chronic hypoparathyroidism, a condition that affects roughly 200,000 patients across the United States and Europe. Top-line data from the study are expected in late 2027 or early 2028. Infigratinib development is also extending into hypochondroplasia, with a phase II update expected in the second half of 2026. BridgeBio also plans to advance a transthyretin depleter, with an investigational new drug (IND) filing targeted for next year. BridgeBio currently carries a Zacks Rank #3 (Hold). BridgeBio Pharma, Inc. price | BridgeBio Pharma, Inc. Quote Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings per share (EPS) estimates for Harmony Biosciences have risen from $3.20 to $3.65 for 2026. Over the same period, EPS estimates have increased from $3.64 to $4.04 for 2027. HRMY shares have risen about 4% year to date. Harmony Biosciences missed on earnings in three of the trailing four quarters and met on one occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen from $4.81 to $5.31. LQDA shares have skyrocketed 164% so far this year. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BridgeBio Pharma, Inc. (BBIO) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management characterizes the current period as 'Launch 2.0' for Attruby, driven by new clinical data demonstrating direct kidney protection and superior real-world evidence compared to competitors. Attruby observed 23% sequential growth, outperforming the broader ATTR-CM market's 19% growth, primarily fueled by gains in the treatment-naive (first-line) patient segment. The failure of a competitor's combination therapy trial (CARDIO-TTRansform) is viewed by management as a strategic validation of stabilizers as the definitive first-line standard of care. The company has successfully transitioned three late-stage programs (LGMD2I/R9, ADH1, and achondroplasia) from clinical development into formal FDA regulatory review within a single quarter. Management attributes Attruby's early clinical separation from placebo to a newly documented hemodynamic effect that protects both heart and kidney function simultaneously. Strategic focus is shifting toward maximizing the 'stabilizer-first' market dynamic, where BridgeBio believes its near-complete stabilizer holds a biological advantage over partial stabilizers. The first of three potential launches is set for BBP-418 with a PDUFA date of November 27, 2026, targeting the first-ever approval for LGMD2I/R9. Management expects significant commercial pull-through from recent kidney and real-world data to materialize in the 6- to 9-month range as prescribing behaviors adjust. The Phase 3 RECLAIM-HP trial for chronic hypoparathyroidism has commenced, with a top-line readout expected within the next 18 months. Achondroplasia launch strategy for infigratinib assumes a mid-2027 approval, with management targeting a peak market share above 65% due to its oral dosing advantage. Financial guidance suggests the operating line will remain stable for several quarters before trending toward breakeven and profitability in 2027. Closed a $1 billion preferred equity financing on July 1, 2026, bringing the total cash balance to approximately $1.7 billion to fund three simultaneous global launches. The 'switch' market for ATTR-CM (patients moving from Vyndaqel) has normalized to a lower steady state now that the initial post-launch bolus has been processed. Management explicitly stated they do not intend to match competitor rebates or engage in 'price games,' relying instead on clinical differentiation to maintain access. The company is maintaining a 30% to 40% gross-to-net range for Attruby despite reported price erosion from competitors in the same space. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management believes the trial failure 'kills' the scientific case for combination therapy, cementing stabilizers as the permanent backbone of treatment. They anticipate that if silencers (knockdowns) do not show early separation or superior 30-month data, the case for using Attruby in both first and second-line settings strengthens. BridgeBio argues that recent competitor data validates a lack of 'brand stickiness,' as families are actively seeking alternatives to daily injections. Management expects the introduction of an oral option to expand the total treated market by two to three times based on historical analogs. Management expects Attruby to continue growing even after competitor tafamidis goes generic in 2031 due to superior potency and kidney-protective differentiation. They noted that specialty pharmacy economics in this space do not typically favor a rapid shift to generics over highly differentiated branded therapies. The absence of planned Advisory Committees for the LGMD2I/R9 and ADH1 filings is viewed as a sign of a healthy regulatory relationship and robust Phase 3 data packages. Management emphasized that their ability to run randomized, placebo-controlled trials with functional endpoints is the 'gold standard' for the FDA's rare disease division.

Interested in BridgeBio Pharma, Inc.? Here are five stocks we like better. Attruby sales continued to accelerate: Second-quarter net product revenue rose to $222.4 million from $71.5 million a year earlier, driven primarily by first-line patients. BridgeBio said the treatment remains on track for worldwide blockbuster sales in 2026. Three late-stage programs advanced toward approval: BBP-418 for LGMD2I and encaleret for ADH1 received FDA priority review, while infigratinib for achondroplasia is targeting FDA acceptance by the fourth quarter of 2026. BridgeBio strengthened its financial position: Total Q2 revenue increased to $243.7 million, and cash, equivalents and marketable securities reached approximately $1.7 billion after a $1 billion preferred equity investment, supporting potential launches and continued development spending. The Phase 3 Failure That Sent Biotech Winners and Losers in Opposite Directions BridgeBio Pharma (NASDAQ:BBIO) reported continued growth for its ATTR cardiomyopathy treatment Attruby in the second quarter of 2026, while advancing three late-stage programs into regulatory review and expanding commercial preparations for potential launches over the next year. Chief Executive Officer Neil Kumar described the period as a transition point for the company, citing the commercial progress of Attruby, regulatory submissions for programs in limb-girdle muscular dystrophy type 2I, autosomal dominant hypocalcemia type 1 and achondroplasia, and the start of a Phase III trial in chronic hypoparathyroidism. → MarketBeat Week in Review – 08/03 - 08/07 BridgeBio's Volatile Week Puts Biotech Stocks Under a Microscope Attruby generated $222.4 million in net product revenue during the second quarter, up from $71.5 million a year earlier and representing another sequential increase of more than $35 million. Chief Commercial Officer Matt Outten said growth was led by treatment-naive, first-line patients, while the pool of patients switching from Pfizer’s Vyndaqel had normalized after a period of elevated switching activity. “The engine is the first-line,” Outten said, adding that BridgeBio’s first-line share increased in a market that was broadly stable sequentially. Kumar said Attruby was the fastest-growing brand in the category, with 23% growth during the quarter, while the overall market grew 19%. → Quantum Earnings Week: Winners and Losers Are Finally Emerging Management said it expects clinical differentiation to remain central to Attruby’s commercialization. Kumar highlighted data published in Circulation: Heart Failure that BridgeBio said showed early and sustained kidney-protective effects for acoramidis, the active ingredient in Attruby, in patients with ATTR cardiomyopathy. The company said the analysis included improvement in chronic eGFR slope and reductions in urinary albumin-to-creatinine ratio. BridgeBio also cited real-world analyses comparing Attruby with tafamidis. Kumar said an independent propensity score-matched study associated Attruby with a 37% reduction in composite cardiovascular events and a 34% reduction in hospitalizations at six months versus tafamidis. A separate company analysis showed a 34% reduction in diuretic intensification, heart-failure hospitalization and mortality, according to Kumar. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War Management said the failure of the CARDIO-TTRansform study’s primary endpoint, which evaluated eplontersen in ATTR cardiomyopathy, could reinforce stabilization therapy as a first-line standard. However, executives said they were awaiting fuller data from the study before updating expectations for Attruby’s long-term market share. BridgeBio said it remains on track for acoramidis to reach blockbuster worldwide sales in 2026, including sales of Beyonttra outside the U.S. recorded by its partners. Outten emphasized that this target was not a forecast specifically for U.S. Attruby net product revenue. BridgeBio said all three of its late-stage programs moved into regulatory review during the quarter. BBP-418 for LGMD2I/R9: The FDA accepted the new drug application on May 27 with priority review. The PDUFA target action date is Nov. 27, 2026, and no advisory committee meeting is planned. Kumar said the treatment could become the first approved therapy for LGMD2I, which the company said affects more than 1,000 patients in the U.S. BridgeBio’s commercial team is already in the field, and the company said it has identified more than 1,500 genetically confirmed patients. Encaleret for ADH1: The FDA accepted the NDA on July 22 and granted priority review. The PDUFA target action date is May 8, 2027, with no advisory committee currently planned. BridgeBio also submitted a marketing authorization application to the European Medicines Agency. The company said more than 2,200 patients had been identified through ICD-10 claims data between October 2023 and June 2026. Infigratinib for achondroplasia: BridgeBio said it has submitted its NDA and is targeting FDA acceptance, potentially including priority review, in the fourth quarter of 2026, with a potential approval in mid-2027. The company said infigratinib could be the first oral FGFR3-targeted treatment for achondroplasia if approved. Kumar said infigratinib demonstrated a statistically significant improvement in arm span in the Phase III PROPEL 3 study, which was published in The New England Journal of Medicine. The company is building its commercial field organization for a market where injectable competitors are already available. BridgeBio also began screening patients in RECLAIM-HP, its global Phase III trial of encaleret in chronic hypoparathyroidism. The company expects top-line results within approximately 18 months. Management said chronic hypoparathyroidism affects about 200,000 people in the U.S. and Europe. Kumar argued that encaleret could offer an oral alternative designed to address both low serum calcium and excess urinary calcium. He cited a Phase II proof-of-concept study in which 80% of postsurgical hypoparathyroidism patients receiving encaleret achieved normal blood and urine calcium levels within five days. Total second-quarter revenue was $243.7 million, compared with $110.6 million in the year-earlier period. The increase was driven primarily by higher Attruby revenue. Royalty revenue rose to $15.4 million from $1.6 million, largely reflecting Beyonttra sales in Europe and Japan. Operating expenses increased to $335.7 million from $241.2 million as BridgeBio expanded sales, marketing, medical affairs and pre-commercial supply activities. The company recorded a loss from operations of $107.1 million, an improvement from a $134.3 million operating loss a year earlier. BridgeBio ended June with $720.2 million in cash, cash equivalents and marketable securities. After closing a $1 billion preferred equity investment led by Sixth Street on July 1, with participation from HealthCare Royalty Partners, the company said its cash balance was approximately $1.7 billion. President and Chief Financial Officer Tom Trimarchi said the capital position is intended to support operating activities, continued Attruby investment and three potential launches over the next 12 months. Management said it expects operating results to remain relatively stable over the next several quarters before improving toward break-even as launch investments reach a steadier level and revenue grows. BridgeBio Pharma, Inc is a clinical-stage biopharmaceutical company headquartered in Palo Alto, California. Founded in 2015 by Neil Kumar, the company is dedicated to discovering, developing and delivering transformative medicines for patients with genetic diseases and cancers. BridgeBio operates an integrated model that spans target identification, preclinical research, clinical development and commercialization, aiming to streamline the process from bench to bedside. BridgeBio's pipeline comprises multiple therapeutic modalities, including small molecules, biologics and genetic therapies. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "BridgeBio Pharma Q2 Earnings Call Highlights" was originally published by MarketBeat. 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- $243.7 million in total second quarter revenues, primarily comprised of $222.4 million of U.S. Attruby® net product revenue, with growth led by the treatment-naïve segment as physicians increasingly start and keep patients on Attruby - Attruby is the first ATTR-CM therapy associated with direct kidney protection, with post-hoc analyses published in Circulation: Heart Failure showing a profile consistent with ACE inhibitors, ARBs, and SGLT2s including an early, reversible eGFR dip, an improved chronic eGFR slope relative to placebo, and a 13.7% reduction in urinary albumin-to-creatinine ratio through Month 30; the magnitude of the acute eGFR dip was positively associated with greater early cardiovascular benefit; BridgeBio will explore the potential for Attruby to treat other orphan kidney indications - Real-world evidence continues to differentiate Attruby from tafamidis, with an independent propensity score-matched analysis of 286 patient pairs from the TriNetX network published in JSCAI associating acoramidis with a 37% reduction in composite cardiovascular events (p=0.002) and a 34% reduction in hospitalizations (p=0.002) at six months; further independent RWE using electronic health records are expected, and we are confident Attruby will consistently demonstrate clinical superiority over tafamidis to the benefit of patients and healthcare delivery systems for which heart failure remains a top concern - All three planned NDAs are now submitted to the FDA: BBP-418 for LGMD2I/R9 was accepted with Priority Review (PDUFA November 27, 2026); encaleret for ADH1 was accepted with Priority Review (PDUFA May 8, 2027), with no advisory committee planned for either; oral infigratinib for achondroplasia has been submitted, with U.S. launch expected mid-2027 - Diagnosis and awareness continue to accelerate ahead of the launches: in ADH, more than 2,200 unique patients are now identified under the dedicated ICD-10 code, at approximately 70 new diagnoses per month; in LGMD2I/R9, BridgeBio is investing in awareness and multidisciplinary care at MDA Care Center Network sites, where we expect 85% of target physicians to be familiar with the BBP-418 profile and data by launch - The oral encaleret and oral infigratinib franchises continue to expand beyond their first indications: RECLAIM-HP in chronic hypoparathyroidism has begun screening patients with topline data anticipated in late 2027 or early 2028, CALIBRATE-PEDS in pediatric ADH1 has completed enrollment in its first cohort, and a Phase 2 update in hypochondroplasia is expected in the second half of 2026 - $720.2 million in cash, cash equivalents, and marketable securities as of June 30, 2026, which does not include the $1 billion preferred equity financing that closed on July 1, 2026 - BridgeBio will host a Commercial Day in New York City on October 8, 2026, to discuss commercial readiness and launch strategy across its three upcoming launches PALO ALTO, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today its financial results for the second quarter ended June 30, 2026, and provided an update on Attruby’s commercial progress. Pipeline Overview: “I'm excited by the growing body of evidence continuing to demonstrate Attruby is the drug of choice for all ATTR-CM patients, and particularly for those who are treatment-naïve, including the first-ever demonstration of early, sustained kidney-protective effects in ATTR-CM alongside the cardiac benefit we've established. Furthermore, this was the quarter all three of our pipeline programs, BBP-418, encaleret, and infigratinib, moved from data into active regulatory review, with our first PDUFA date now set for November 27, 2026, which is a level of strategic execution and discipline I'm proud of. Finally, with the $1 billion preferred equity financing we completed, we have a balance sheet sized to run all three launches at full strength, without diverting resources from the development engine that produced them,” said Neil Kumar, Ph.D., Co-Founder and CEO of BridgeBio. Commercial Updates:The second quarter total revenues, net totaled $243.7 million, comprised of $222.4 million of U.S. Attruby net product revenue, $15.4 million from royalty revenue, and $5.8 million in license and services revenue. “We continue to see strong growth this quarter for Attruby with our first-line share climbing again,” said Matt Outten, Chief Commercial Officer of BridgeBio. “What comes next will continue to shape BridgeBio’s next chapter as we prepare for three potential approvals in three different diseases, all with best-in-class potential, each backed by the same commercial engine that made Attruby a success. We look forward to continuing to deliver for patients and addressing the gaps within the treatment paradigm for rare disease.” Pipeline Updates:Attruby (acoramidis) – First and only near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM): New post-hoc analyses published in Circulation: Heart Failure showed acoramidis was associated with a rapid, reversible estimated glomerular filtration rate (eGFR) dip alongside a placebo-corrected 15.5% reduction in urinary albumin-to-creatinine ratio (UACR) by Day 28, followed by a sustained improvement in chronic eGFR slope (+2.47 mL/min/1.73m²/year) and a 13.7% UACR reduction through Month 30. This profile resembles that of direct-acting kidney medicines such as ACE inhibitors, ARBs, and SGLT2 inhibitors, and has not previously been observed with any approved ATTR-CM therapy. Participants with larger eGFR dips had a 58% lower risk of death or cardiovascular hospitalization in year one, suggesting the kidney effect may contribute to acoramidis' early cardiovascular benefit. New data from ATTRibute-CM presented in two late-breaking oral presentations at Heart Failure 2026 further demonstrated acoramidis’ differentiated clinical profile. The first showed a reduction in the risk of outpatient worsening heart failure by 41% versus placebo with separation of curves seen within 30 days and sustained through Month 30. The second showed a significant reduction in serum transthyretin variability, which is associated with lower mortality. Real-world evidence continues to demonstrate that Attruby is differentiated from other therapies in the speed and strength of benefit. An independent propensity score-matched analysis of 286 patient pairs from the TriNetX network, presented at SCAI 2026 Scientific Sessions and published in JSCAI, associated acoramidis with a 37% reduction in composite cardiovascular events (HR 0.63; p=0.002) and a 34% reduction in hospitalizations (HR 0.67; p=0.002) at six months, with effects deepening at nine months and significant reductions across heart failure exacerbation, arrhythmia, and acute kidney injury. A separate propensity score-weighted analysis observed a 43% reduction in outpatient diuretic intensification (HR 0.57; p=0.021) versus tafamidis. A third independent study conducted in EPIC COSMOS and to be published later in 2026 validated the comparative effectiveness of acoramidis over tafamidis. These three real-world datasets converge on consistent, statistically significant benefit in contemporary patients on modern background therapy, reinforcing that Attruby's stabilization advantage is showing up in outcomes that matter to physicians, patients, and payers. BridgeBio initiated ASCEND-ATTR, a Phase 4 study using cardiac MRI and echocardiography to characterize the long-term effects of acoramidis on disease reversal as measured by cardiac structure, function, and amyloid burden over 36 months. This builds on the evidence of regression observed in ATTRibute-CM and the open-label extension. Additional data will be shared in two oral presentations and six moderated posters at the European Society of Cardiology (ESC) Congress 2026. BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9): BridgeBio believes BBP-418 is positioned to become the first approved therapy for individuals living with LGMD2I/R9, addressing a significant unmet need in this disease and potentially representing the first approval of a therapy for any form of LGMD. On May 27, 2026, the FDA accepted the Company's New Drug Application (NDA) for BBP-418 and granted Priority Review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. No advisory committee meeting is currently planned. FORTIFY, the Phase 3 clinical trial of BBP-418, successfully met all pre-specified primary and secondary endpoints of its 12-month interim analysis, supporting its potential as a disease-modifying therapy. The topline results can be found here. Additional positive results demonstrating the rapid and consistent treatment effect and favorable safety profile of BBP-418 were presented in March at the 2026 MDA Clinical and Scientific Conference in a late-breaking oral presentation.1 At the 19th International Congress on Neuromuscular Diseases in July 2026, BridgeBio presented interim FORTIFY data showing favorable patient-reported outcomes for BBP-418-treated individuals compared to placebo, demonstrating that the improvements observed on functional outcomes and biomarkers translate to how patients feel and function. BridgeBio invested $100,000 to strengthen multidisciplinary LGMD care through a Muscular Dystrophy Association (MDA) Care Advance Grant supporting initiatives at Stanford Health Care and the University of Minnesota and engaged the LGMD2I/R9 community at the 2026 European LGMD2I/R9 Conference and the 2026 Iowa Wellstone Dystroglycanopathy Patient & Family Conference. BridgeBio's neuromuscular U.S. field teams are hired, trained, and deployed across medical, commercial, and market access, engaging in scientific exchange, disease state education, and account profiling as appropriate in the pre-approval setting. Promotional activity will commence only upon FDA approval, consistent with regulatory requirements. Based on the FORTIFY interim analysis results, BridgeBio is also engaging regulatory agencies to identify an expedited path to approval for BBP-418 in Europe. The Company intends to initiate clinical studies of BBP-418 in LGMD2I/R9 for individuals less than 12 years of age in the first half of 2027, and in LGMD2M/R13 and LGMD2U/R20 in the near future. Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism: BridgeBio believes encaleret is positioned to become the first approved therapy specifically indicated for individuals living with ADH1, in both the U.S. and the EU. The FDA re-considered its review designation of the Company's NDA filing for encaleret in ADH1 and has granted Priority Review, with a PDUFA target action date of May 8, 2027. No advisory committee meeting is currently planned. BridgeBio submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of encaleret in ADH1. Diagnosis of ADH1 in the U.S. continues to accelerate, with more than 2,200 unique patients identified under the dedicated ICD-10 code for ADH (E20.810) from its introduction in October 2023 through June 2026, a rate of approximately 70 new diagnoses per month. CALIBRATE-PEDS, the registrational Phase 2/3 study of encaleret in pediatric ADH1, completed enrollment in the first of four cohorts (adolescents 12 to 17 years of age). RECLAIM-HP, the Phase 3 study of encaleret in chronic hypoparathyroidism, has activated its first investigational sites and screening has initiated. Chronic hypoparathyroidism affects approximately 200,000 patients in the U.S. and EU, and represents a substantial expansion of the encaleret opportunity beyond ADH1. Oral infigratinib – FGFR3 inhibitor for achondroplasia and hypochondroplasia: BridgeBio believes oral infigratinib is positioned to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia. The Company submitted an NDA to the FDA for oral infigratinib in achondroplasia and is on track to submit an MAA to the EMA in the fourth quarter of 2026. BridgeBio anticipates a U.S. launch in mid-2027 and an EU approval in the second half of 2027. Oral infigratinib has received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations from the FDA, and Orphan Drug designation from both the FDA and the EMA. Results from PROPEL 3, the Phase 3 trial of oral infigratinib in achondroplasia, were published in the New England Journal of Medicine2 and simultaneously presented at the International Congress of Children's Bone Health 2026. Oral infigratinib is the only achondroplasia program with Phase 3 results published in the New England Journal of Medicine. In these results3, oral infigratinib significantly improved arm span Z-score versus placebo (LS mean +0.37 SD; p<0.0001) at 52 weeks, the first statistically significant placebo-controlled arm span improvement reported in an achondroplasia trial. PROPEL 3 achieved its pre-specified primary efficacy endpoint of change from baseline in absolute height velocity at Week 52 (phere. U.S. commercial and medical affairs leadership are in place, with the field medical team fully onboarded and regional sales directors building field teams aligned to the diagnosed and treatable population living with achondroplasia. The Company has initiated development of the achondroplasia program from birth to under 3 years of age and is actively enrolling participants. The Company is enrolling participants in the observational run-in study for the Phase 3 trial in hypochondroplasia. An update of the Phase 2 program in hypochondroplasia is expected in the second half of 2026. _______________1 https://investor.bridgebio.com/news/news-details/2026/BBP-418-Demonstrates-Consistent-Efficacy-and-Favorable-Safety-Profile-in-Phase-3-FORTIFY-Interim-Analysis-in-LGMD2IR9/default.aspx2 https://www.nejm.org/doi/10.1056/NEJMoa26045653 https://investor.bridgebio.com/news/news-details/2026/BridgeBio-Announces-Publication-in-the-New-England-Journal-of-Medicine-of-Phase-3-PROPEL-3-Trial-of-Oral-Infigratinib-in-Children-Living-with-Achondroplasia/default.aspx Corporate Updates: On July 1, 2026, BridgeBio closed $1 billion in preferred equity led by Sixth Street with participation from HealthCare Royalty, an affiliate of KKR. The financing enables BridgeBio to fund three potential upcoming launches while continuing to invest in indication expansion across the pipeline. Financial Updates: Cash, Cash Equivalents and Marketable Securities Cash, cash equivalents and marketable securities totaled $720.2 million and $587.5 million as of June 30, 2026 and December 31, 2025, respectively. Total Revenues, Net Total revenues, net for the three months ended June 30, 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 net product revenue from Attruby, and a $13.8 million increase in royalty revenue primarily earned from net product sales of BEYONTTRA in the EU and Japan. These increases were partially offset by a decrease in license and services revenue primarily due to recognition of $30.0 million of regulatory milestone-related revenue during the three months ended June 30, 2025. Total revenues, net for the six months ended June 30, 2026 were $438.2 million compared to $227.2 million for the same period in 2025. The $211.0 million increase was primarily driven by a $294.8 million increase in net product revenue from Attruby, and a $23.1 million increase in royalty revenue primarily earned from net product sales of BEYONTTRA in the EU and Japan. These increases were partially offset by a decrease in license and services revenue primarily due to recognition of $105.0 million of regulatory milestone-related revenues during the six months ended June 30, 2025. Total Operating Costs and Expenses Total operating costs and expenses for the three months ended June 30, 2026 were $350.8 million, compared to $244.8 million for the same period in 2025. The $106.0 million increase was primarily driven by a $57.1 million increase in selling, general and administrative (SG&A) expenses, reflecting continued investment in both the ongoing commercialization of Attruby and the pre-commercial activities for BridgeBio's Phase 3 product candidates, a $38.2 million increase in research and development (R&D) expenses to support the development of late-stage product candidates, and an $11.4 million increase in total cost of revenues primarily due to higher sales volume of Attruby. Total operating costs and expenses for the six months ended June 30, 2026 were $651.2 million, compared to $465.8 million for the same period in 2025. The $185.4 million increase was primarily driven by a $114.6 million increase in SG&A expenses, reflecting continued investment in both the ongoing commercialization of Attruby and the pre-commercial activities for BridgeBio's Phase 3 product candidates, an $18.7 million increase in total cost of revenues primarily due to higher sales volume of Attruby, and a $53.4 million increase in R&D expenses to support headcount growth and the development of late-stage product candidates. Stock-based compensation expenses included in operating costs and expenses for the three months ended June 30, 2026 were $44.5 million, of which $28.4 million, $15.4 million, and $0.7 million were included in SG&A expenses, R&D expenses, and cost of goods sold, respectively. Stock-based compensation expenses included in operating costs and expenses for the same period in 2025 were $37.3 million, of which $23.2 million, $14.0 million, and $0.1 million were included in SG&A expenses, R&D expenses, and cost of goods sold, respectively. Stock-based compensation expenses included in operating costs and expenses for the six months ended June 30, 2026 were $77.9 million, of which $48.6 million, $27.6 million, and $1.7 million were included in SG&A expenses, R&D expenses, and cost of goods sold, respectively. Stock-based compensation expenses included in operating costs and expenses for the same period in 2025 were $66.7 million, of which $41.2 million, $25.3 million, and $0.2 million were included in SG&A expenses, R&D expenses, and cost of goods sold, respectively. Total Other Expense, Net Total other expense, net for the three and six months ended June 30, 2026, was $(48.8) million and $(109.4) million, respectively, compared to $(47.4) million and $(112.6) million, respectively, for the same periods in 2025. The increase in total other expense, net of $1.4 million for the three months ended June 30, 2026, compared to the same period in 2025 was primarily driven by a $15.3 million increase in noncash interest expense related to deferred royalty obligations, and was partially offset by a $13.8 million decrease in net loss from equity method investments. The decrease in total other expense, net of $3.2 million for the six months ended June 30, 2026, compared to the same period in 2025 was primarily driven by a $21.2 million decrease in loss on extinguishment of debt recognized in 2025, and an $11.0 million decrease in net loss from equity method investments. These decreases were partially offset by a $31.2 million increase in noncash interest expense related to deferred royalty obligations. Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share For the three and six months ended June 30, 2026, the Company recorded a net loss attributable to common stockholders of BridgeBio of $152.2 million and $316.3 million, respectively, compared to $181.9 million and $349.3 million, respectively, for the same periods in 2025. For the three and six months ended June 30, 2026, the Company reported a net loss per share of $0.78 and $1.62, respectively, compared to $0.95 and $1.84, respectively, for the same periods in 2025. (1) Including related party amounts of $(5,575) and $(10,936), respectively, for the three and six months ended June 30, 2026. (1) The condensed consolidated balance sheet as of December 31, 2025 is derived from the audited consolidated financial statements as of that date.(2) Including related party amounts of $5,626 and $2,003 as of June 30, 2026 and December 31, 2025, respectively.(3) Including related party amounts of $206,208 and $204,650 as of June 30, 2026 and December 31, 2025, respectively. (1) Including a related party amount of $10,936 for the six months ended June 30, 2026.(2) Including a related party amount of $5,626 for the six months ended June 30, 2026.(3) Including a related party amount of $(5,784) for the six months ended June 30, 2026. Webcast InformationBridgeBio will host a conference call and webcast to discuss second quarter financial results today, August 10, 2026, at 4:30 pm ET. This event can be accessed at https://events.q4inc.com/attendee/919782907 or by visiting the “Events & Presentations” page within the Investors section of the BridgeBio website at http://investor.bridgebio.com. A replay of the webcast will be available on the BridgeBio website for 30 days following the event. About Attruby® (acoramidis)INDICATIONAttruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. IMPORTANT SAFETY INFORMATIONAdverse ReactionsDiarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively). About BridgeBio Pharma, Inc.BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok. BridgeBio Pharma, Inc. Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including express and implied statements relating to the continued commercial success and market potential of Attruby/Beyonttra (acoramidis); the Company’s expectations regarding timing of regulatory submissions and target action dates, approvals and commercial launches in the U.S. and Europe, including for BBP-418 in LGMD2I/R9, encaleret in ADH1, and infigratinib in achondroplasia; the Company’s expectations regarding the timing and outcome of pre-commercial activities, including activities designed to support three potential launches; the timing of the Company’s clinical trials, milestones and expected updates for its various programs and pipeline; the safety and the potential benefits of the Company’s product and product candidates; the Company’s anticipated presentations of data; and the Company’s belief that its recent financing will enable the Company to fund its potential launches and expansion across its pipeline. Such statements reflect the Company’s current views about the Company’s plans, intentions, expectations and strategies, which are based on the information currently available to it and on assumptions the Company has made. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, initial and ongoing data from the Company’s preclinical studies and clinical trials not being indicative of final data, the potential size of the target patient populations the Company’s product candidates are designed to treat not being as large as anticipated, the design and success of ongoing and planned clinical trials, future regulatory filings, approvals and/or sales, despite having ongoing and future interactions with the FDA or other regulatory agencies to discuss potential paths to registration for the Company’s product candidates, the FDA or such other regulatory agencies not agreeing with the Company’s regulatory approval strategies, components of the Company’s filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted, the Company’s pre-commercial activities, commercial launches or operational execution not occurring on anticipated timelines or not supporting planned launches as expected, real-world experience with Attruby/Beyonttra not being consistent with observed biochemical differentiation or not translating into differentiated clinical, commercial or market outcomes, the continuing success of the Company’s collaborations, the Company’s ability to obtain additional funding, including through less dilutive sources of capital than equity financings, potential volatility in the Company’s share price, the Company’s share repurchase program being modified, suspended or discontinued, or share repurchases not delivering the anticipated benefits or proving to be a more attractive use of capital than other alternatives, the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Media Contact:Bubba Murarka, Executive Vice [email protected](650)-789-8220 BridgeBio Investor Contact:Kristen Kelleher, Director of Investor [email protected]

Viatris VTRS, a global healthcare company, is scheduled to report second-quarter 2026 results on Aug. 6, before the opening bell. The Zacks Consensus Estimate for second-quarter revenues is pegged at $3.68 billion, while the same for earnings is pinned at 62 cents per share. The company reports under four segments based on geography — Developed Markets, Emerging Markets, Japan, Australia and New Zealand (“JANZ”) and Greater China. Developed Markets sales are expected to rise, though growth in North America may be tempered by the Indore manufacturing facility import alert. Solid growth in EpiPen, Creon and Viatris’ thrombosis portfolio is likely to have enabled it to partially absorb the anticipated competition for Dymista. Incremental revenues from new products, such as iron sucrose, are likely to have boosted the quarterly top line. Following an inspection of Viatris' oral finished dose manufacturing facility in Indore, India, in June 2024, the company received a warning letter and import alert from the FDA in December 2024. The import alert affected 11 actively distributed products, including lenalidomide and everolimus. The Zacks Consensus Estimate for revenues from Developed Markets is pinned at $2.18 billion. Sales from Emerging Markets are expected to have experienced growth, driven by branded business in Turkey, Mexico and certain Asian markets. The generic business is likely to have seen growth due to the stabilization of supply for certain lower-margin ARB products. The Zacks Consensus Estimate for revenues from this geography is pegged at $558.5 million. Viatris shares have surged 41.6% year to date against the industry’s 1.1% decline. Image Source: Zacks Investment Research Sales in JANZ are likely to have been adversely impacted by lower net sales of existing products in Japan and Australia due to government price reductions and additional competition. The Zacks Consensus Estimate for revenues from the JANZ markets is pinned at $285.1 million. Sales in Greater China might have increased due to strong growth across multiple channels, including e-commerce, retail and private hospitals, as a result of higher marketing and selling efforts. The Zacks Consensus Estimate for revenues from this geography is pegged at $631.7 million. Viatris also reports revenues under two divisions (in terms of product category) — brands and generics. The brand business comprises the majority of the company’s portfolio. Brand performance is likely to have benefited from strong performance in Greater China and Emerging Markets, in addition to growth in certain key brands in Developed Markets. However, the generics business is likely to have been negatively impacted by inspection at the Indore facility and competition for Wixela, partially offset by continued growth in Yupelri and Breyna in North America, strong performance across key European markets, and slight volume growth in JANZ. On the profitability front, gross margin is likely to have been stable. Total operating expenses in the second quarter of 2026 are likely to have declined as a result of the planned cost-saving initiatives. Viatris’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 10.04%. In the last reported quarter, VTRS beat on earnings by 13.46%. Our proven model does not conclusively predict an earnings beat for VTRS this time around.  The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. Earnings ESP:Viatris has an Earnings ESP of -0.81% as the Most Accurate Estimate of 61 cents per share is just shy of the Zacks Consensus Estimate of 62 cents. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter. Zacks Rank:VTRS currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank stocks here. Viatris Inc. price-consensus-eps-surprise-chart | Viatris Inc. Quote Here are some stocks worth considering from the healthcare space, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle. ACADIA Pharmaceuticals ACAD has an Earnings ESP of +25.00% and a Zacks Rank #2 at present. Shares of ACAD have lost 4.1% year to date. The company’s earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average surprise of 20.83%. Acadia is scheduled to report second-quarter results on Aug. 4, after market close. Arcutis Biotherapeutics ARQT has an Earnings ESP of +52.94% and a Zacks Rank #2 at present. Shares of ARQT have lost 10.7% year to date. The company’s earnings beat estimates in three of the trailing four quarters but missed in the remaining quarter, delivering an average surprise of 42.78%. ARQT is scheduled to report second-quarter results on Aug. 5. BridgeBio Pharma BBIO has an Earnings ESP of +13.69% and a Zacks Rank #3 at present. Shares of BBIO have risen 4.5% year to date. BridgeBio Pharma’s earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 18.94%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Viatris Inc. (VTRS) : Free Stock Analysis Report ACADIA Pharmaceuticals Inc. (ACAD) : Free Stock Analysis Report BridgeBio Pharma, Inc. (BBIO) : Free Stock Analysis Report Arcutis Biotherapeutics, Inc. (ARQT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Alnylam Pharmaceuticals lost nearly 30% — or close to $12 billion — of its market value after the company surprised investors by lowering financial forecasts for its most important drug franchise by $200 million. The RNA-focused biotechnology company had previously predicted those drugs, the transthyretin amyloidosis medications Amvuttra and Onpattro, would bring in $4.4 billion to $4.7 billion. But in an earnings report Thursday, it dropped that estimate to between $4.2 billion and $4.5 billion, revealing that Amvuttra’s early launch spike benefitted from “pent-up demand” that’s since “normalized.” Alnylam has been in a high-stakes battle over the last year to carve out a share of the multibillion-dollar “TTR cardiomyopathy” market, which has become increasingly competitive thanks to drugs like Pfizer’s Vyndamax, BridgeBio’s Attruby and, potentially, AstraZeneca and Ionis Pharmaceuticals’ eplontersen. Alnylam had already seen its share price slide by a double-digit percentage after a study setback for eplontersen in July raised thorny questions about how useful drugs like Amvuttra are in patients on other treatment. The latest news, then, represented a “one-two punch” for Alnylam that may hang over the company until the presentation of that failed study at a medical meeting in late August, wrote Cantor Fitzgerald analyst Olivia Brayer Saunders. “We knew expectations for 2026 were ambitious, but we weren’t expecting a guidance cut,” she wrote. Oppenheimer analyst Kostas Biliouris echoed that sentiment in his own note. While some investors may have been expecting a guidance reduction, “it comes as a surprise to us” for one to come this early in the year, especially since prescription rates tracked by healthcare data specialist Iqvia suggest the company could meet its original predictions. Amvuttra sales totaled $1.01 billion for the quarter, or 3% below the average analyst estimate of $1.05 billion, according to Biliouris. Alnylam shares traded around $200 apiece by late Thursday afternoon, down from a $286 close the previous day. The earnings miss and guidance cut invites “major” questions on the outlook of Alnylam’s TTR business, wrote Jefferies analyst Faisal Khurshid. The “bull/bear debate ... is real, and today’s update underscores the complexity.” Khurshid added that his team doesn’t envision “the overhang passing easily,” and is “not convinced there’s enough investor interest” in Alnylam’s pipeline to “make up for TTR uncertainty.” Recommended Reading Alnylam reaches new highs on strong sales of closely watched rare disease drug

BridgeBio Pharma (BBIO) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This rare disease drug developer is expected to post quarterly loss of $0.63 per share in its upcoming report, which represents a year-over-year change of +33.7%. Revenues are expected to be $223.36 million, up 102% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 0.53% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For BridgeBio Pharma, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +13.69%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that BridgeBio Pharma will most likely beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that BridgeBio Pharma would post a loss of$0.7 per share when it actually produced a loss of -$0.84, delivering a surprise of -20.00%. The company has not been able to beat consensus EPS estimates in any of the last four quarters. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. BridgeBio Pharma appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BridgeBio Pharma, Inc. (BBIO) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research