Greetings and welcome to the Edwards Life Sciences second quarter, 2026 earnings conference call. At this time, all participants are in a listen-only mode. The question and answer session will follow a formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference call is being recorded. It is now my pleasure to introduce Jerry Ansarte, Head of Investor Relations. Thank you. You may begin.

Good afternoon, and thank you for joining us. With me on today's call is our CEO, Bernard Zavigian, and our CFO, Doretta Mistris. Also joining us for the Q&A portion of the call will be Dan Lippis, our global leader of TAVR, and Devine Chopra, who has global responsibility for TMTT, surgical, and IHSM. After the close of regular trading, Edwards Life Sciences released second quarter 2026 financial results during today's call management will discuss the results included in the press release and accompanying financial schedule and then use the remaining time for Q&A please note that management will be making forward-looking statements that are based on estimates assumptions and projections these statements speak only as of the date on which they are made and Edwards does not undertake any obligation to update them after today Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause these differences can be found in today's press release and Edwards' other SEC filings, all of which are available on the company's website at Edwards.com. Unless otherwise noted, our commentary on sales growth refers to underlying sales growth, which is defined in the financial results press release issued earlier today reconciliations between gap and non-gap numbers mentioned during this call are also included in today's press release quarterly and four-year growth rates refer to continuing operations with that I'll turn it over to Bernard for his comments Bernard thank you giant and welcome everyone before we begin I'd to welcome doretta to our first edward life sciences earnings call since joining in june doretta has quickly demonstrated her impact and valuable contribution as a member of the team

and we are pleased to have her leadership as we deliver on our patient-centered innovation strategy and our commitments to sustainable distinguished performance let me begin with a high-level comment on our quarterly performance. We delivered stronger than expected second quarter self-growth of 12.5%. As Evers continues to invest in new structural health therapies and expand adoption globally, our results increasingly reflect the strength of our comprehensive portfolio, with growth supported by multiple therapies across TAVR, MITRE, trical speed and surgical as well as meaningful contribution from each of our regions today our company profile has evolved to include multiple strategic platforms across multiple regions that will support durable growth giving us confidence in our target of 10 percent total company sales growth on average over the long term for those most familiar with edwards you know that the long-term differentiation of our performance begins with our singular focus on transforming care in structural heart disease. These, combined with our commitment to early innovation and agile execution, enable us to create new categories and expand access for patients. Equally important is our culture. Our 16,000 employees around the world are aligned with our vision, inspired by their work, and dedicated to delivering exceptional innovation for patients in need. This dedication to developing safe and effective therapies requires unwavering focus, deep expertise, and a commitment to generating world-class evidence, both on our therapies and the diseases they address, capabilities that distinguish Edwell's as a trusted partner. Our history of innovation has transformed care for patients around the world and we know from this experience that establishing new therapeutic categories and changing the practice of medicine requires deep and sustained commitment. We believe this foundation positions Edwards to live the future of these therapies for many years to come. As a result of this strategy and focus, Edwards is able to make a differentiated impact and develop best-in-class technologies in TAVR, TMTT, and surgical. Speaking more specifically, in TAVR, years of technology advancement, development of world-class evidence, and partnership with clinicians have positioned Sapien as the standard of care for tether treatment setting the benchmark for valve performance and durability we are committed to continuing to raise the bar for both technology and clinical data while transforming the lives of aortic stenosis patients around the world in tnt our years of pioneering development and strategic investment have resulted in multiple unique therapies that enables physicians to offer options to the clinically diverse patients suffering from mitral and tricuspid disease. As we continue to build and expand, each of our therapies is advancing along its adoption curve, enabling us to extend these technologies to a broader population of patients. In surgical, building on 70 years of innovation and leadership, we are continuing to partner with surgeons around the needs of their complex patients by expanding our leadership in valves as well as over therapies to address the many patients best treated surgically at the same time we are executing our proven innovation strategy to extend our leadership into structural heart failure and aortic regitation which also present large unmet patient needs and longer term growth opportunities generating world-class evidence is a key element of our strategy we continue to demonstrate the company leadership in advancing high quality science and iterating for patients through several important clinical presentations at the recent new york valves conference these new data spanning aortic mitral and tricuspid therapies provide further understanding of a complexity of structural heart disease and the need for innovative treatment options across it once the result of a unique strategy and strong execution is reflected in the significant advancements that are building the foundation for continued long-term growth in TAVR this includes long-term sapient valve performance and the asymptomatic indication, both supported by differentiated evidence. In TNTT, PASCAL, EVOC, and SAPIEN M3 continue to scale globally, and in Surgical, this includes continued expansion of our portfolio. Ahead of us, in the remainder of the year, we anticipate the finalization of the updated U.S. tavern in city and the presentation of progress trial results, a new TR indication for Pascal in the U.S., the launch of next generation Pascal technology in the U.S. and Europe, and the introduction of surgical left atrial appendage with ecliptis in the U.S. Altogether, we believe these important advancements represent multi-year opportunities that will materialize gradually over time. This underpins our annual sales growth targeting 10% on average alongside operating margin expansion for the company, with further growing mid to high single digits. As we create and shape new therapeutic categories and achieve important clinical, regulatory, and commercial milestones, there may be some minor variability in growth rate within therapeutic areas. But the more meaningful takeaway is the long-term durability of our growth and distinguished performance. Combined with our financial strength, this gives us confidence. Confidence in both the short term and confidence in the long term. Then we now turn to our financial expectation for the rest of the year. Given our second quarter performance, we are increasing our full year 2026 sales growth guidance for TAVR, TMTT and Total Company and reaffirming our earnings guidance. Our updated 2026 sales guidance is 10 to 11% for the company with strong earnings leverage and operating margin expansion. as a reminder our second half performance in 2025 set a higher bar for the second half of 2026. in summary let me put our durable performance in perspective after delivering a strong 2025 we are on track to deliver on our increased company guidance of 10 to 11 person this year and remain confident in our longer-term outlook. Now, I will provide more detail about the performance of our product groups. Traverse second-quarter global sales of $1.3 billion were stronger than expected and increased 10.5% over the prior year. Globally, procedural growth benefited from sustained clinical momentum and data supporting proactive disease management of CVRS. At the same time, treatment decisions continue to be shaped by the long-term differentiation of our sapient platform. Edwards' growth rates were similar in the U.S. and outside of the U.S. Growth also benefited from the exit of a competitor in Q2 2025 and compelling long-term sapient durability data. Average selling prices were stable globally. At the recent New York valve conference, a new Parallel-Free sub-analysis of a Sapien platform at seven years reinforced the best-in-class valve performance and long-term durability of Edwards TAVR. Further, a five-year analysis from the early TAVR trial adds to the growing evidence supporting a shift toward treating aortic stenosis patients earlier in the disease pathway. Also, at New York Vals, the PROGRESS trial presentation on baseline characteristics provided you a new insight into the heterogeneous nature of moderate AS patients. Research has shown that approximately half of these patients present with at least one at-risk feature. The PROGRESS trial is designed to evaluate whether this patient may benefit from TAVR earlier than current guidelines of surveillance suggest. We will learn more about the clinical relevance of treating this patient with TAVR when the PROGRESS trial results are presented at TCT later this year. We were also pleased to share an update on our next-generation Sapien platform Through our unwavering focus on innovation, we continue to elevate our best-in-class TAVR technology. And the first patients have now been treated with the updated Sechen X4S. We are excited about this innovative platform and look forward to sharing more when the Alliance trial is complete. Let me now turn to some commentary on US TAVR. In Q2, procedure growth continued to benefit from the heightened focus on the therapy as the clinical community further incorporates into practice the meaningful evidence supporting proactive disease management. A lot of competitive position in the U.S. increased modestly year over year, enabled by continued adoption of sapient-free ultra-resilia. We are also pleased that CMS continues to prioritize and progress the reconsideration of the NCD for TAVR, and we look forward to the final policy in September. Based on the draft coverage policy, we are encouraged that this update has the potential to advance TAVR therapy for Medicare beneficiaries with aortic stenosis. Outside of the U.S., we continue to see strong adoption of sapiens. In Europe, updated ESE and EACTS guidelines are helping shape clinical discussion around earlier intervention and proactive disease management, further reinforcing the role of TAVR across a broader patient population. Edwards' competitive position increased modestly year-over-year in Europe, which included what we believe to be the final quarter of benefit from a competitor exiting the market. In Japan, we are encouraged by the growth and continued adoption of Sapien-free ultra-resilia. We also received the asymptomatic indication approval in Japan. In summary, we are pleased with our TAVR performance, and given our two-two results, we are increasing our full-year sales growth guidance to 8% to 9% from 7% to 9%. Edward's leadership in TAVR, built on differentiated innovation, world-class clinical evidence, and continued education expansion, is increasing patient access and supporting a sustained adoption of a second platform, creating a durable, mid- to high-single-digit, long-term growth opportunity. With that, let me turn to two of our important growth drivers in Mitra and Frecaspid. Our differentiated TMTT repair and replacement therapies drove second quarter sales of $195.9 million, an increase of 44.8% year over year. Globally, mitral and freckless pill procedural growth remained in the double digits. Growth from our differentiated TMTT platforms, Pascal, Evoque, and Sepian Enfuy, exceeded our expectation in the quarter. Individually, each therapy delivers meaningful benefits for patients and health care systems. Collectively, they provide physicians with a comprehensive set of options to tailor treatment to a broader range of patients, with the goal of eliminating their hesitation, which indicates better outcomes for patients. Adoption of PASCAL continues to increase, reflecting strong physician interest for its differentiated design and clinical outcomes, as well as the significant unmanaged needs of mitral and requisite patients. At last month's New York VAL conference, Real World Outcome demonstrated sustained safety and effectiveness of the PASCAL precision system for one year in a broad population of more than 4,600 U.S. DMR patients. We continue to expect that our next generation PASCAL with Capture Clarity technology for both mitral and tricuspid patients in the U.S. and Europe will be approved in the fourth quarter. Also, in the fourth quarter, we continue to expect class 2-tier results to be presented at TCT and the launch of PASCAL in the U.S. for tricuspid patients. This launch expands the population of patients that can benefit from this impactful therapy and adds another layer of growth for TMTT. Evoke is a significant growth platform from TMTT and continues to scale in the US and Europe. We are increasing patient access to Evoke and driving further adoption by expanding into new centers, deepening utilization in existing centers, and streamlining patient screening processes. We believe the value of a growing body of clinical evidence will further increase with time, as demonstrated by recent reduction in all-cause mortality and heart failure hospitalization, and will support continued physician adoption and expansion of access for patients with TR. Turning to CPNM3, our early experience validates the significant need for mitral replacement solution for patients who are not well suited for mitral tear or surgery and demonstrate excellent clinical outcomes for patients. We continue to execute a major launch of CPNM3 in the US and in Europe, steadily opening new centers and supporting sites as they build procedural experience. During the quarter, results from the in-circle micelle annular classification, or MAC, were presented at New York Valve, demonstrating low 30D mortality, virtual illumination of regurgitation, and impactful quality-of-life improvements. In Q2, we also received CMARC for SAPIEN M3 Resilia and broadened our indication for SAPIEN M3 and SAPIEN M3 Resilia to include patients with MAC, increasing access to therapy for a patient population with a significant unmet need. In summary, we enter the second half of 2026 with both a strong foundation and multiple opportunities to further strengthen our position in TMTT. As a result of our continued sustainable performance, we are increasing TMTT self-guidance to $760 to $780 million from $740 to $780 million. Together, Pascal for Michael, Evoque, CPLM3, and Pascal for practice feed represent layers of durable growth that support our path to $2 billion in TMTT revenue in 2030 and position us for additional growth beyond. In surgical, second quarter global sales of $284 million increased 5% over the prior year. driven by continued adoption of our portfolio of Resilia therapies, including Inspiris, Mitris, and Connect, which provided extended durability for patients. At the recent AATS conference, 10-year data from our comments trial studying the long-term durability of our best-in-class Resilia tissue were presented. The results showed favorable 10-year freedom from structural valve deterioration, or SVD, and a very low rate of SVD-related re-operation regardless of age, even in a relatively young cohort. This defining 10-year clinical milestones adds to the growing body of clinical evidence supporting the long-term performance of Resilia as a differentiated tissue technology. We also received U.S. approval for eclipses of surgical left astral appendage technology and are planning for a measure rollout later this year, supported by a continued focus on procedural excellence and patient outcomes. In summary, our progress in the quarter reflects our long-term commitment to meaningful innovation, lifetime care, and expanded option for underserved surgical patients. And we continue to expect mid-single-digit sales growth in surgical in 2026. With that, pass it over to the director to cover the details of our financial results.

Thank you, Bernard. I'm pleased to join you all today to cover our second quarter results. Before I begin, I want to say how excited I am to be part of Edwards and supporting the important work we are doing to meaningfully impact patient lives over the past several weeks I've had the opportunity to spend time across the organization meeting many of our employees and getting to know many of our analysts and investors I look forward to continuing to build upon these relationships going forward now turning to our financial results we are pleased with our financial performance in the quarter, including strong top-line growth and earnings leverage. Total sales of $1.74 billion grew 12.5% year-over-year, reflecting strength across all product groups and regions. Adjusted EPS in the quarter was $0.78. Based on our second quarter performance we are increasing our full year sales guidance for a total company to 10 to 11 percent from 9 to 11 percent TAVR sales guidance to 8 to 9 percent from 7 to 9 percent and TMTT guidance to 760 to 780 million dollars from 740 to 780 million dollars Edwards now expects total company sales of 6.6 to $6.9 billion and TAVR sales of $4.75 to $5 billion at current exchange rates. As a reminder, our second-half performance in 2025 set a higher bar for the second half of 2026, particularly in the third quarter when we experienced unusually low impact from seasonality last year. Moving to EPS, we have confidence in delivering our previously increased full-year adjusted EPS guidance of $2.95 to $3.05, despite now assuming our effective tax rate will be at the high end of our original 16% to 19% range, driven by Pillar 2 impact and changes to California law restricting the usage of R&D credits. I'll now cover additional details of our Q2 results, starting with EPS. Adjusted EPS of 78 cents in the quarter benefited from our better than expected top line performance, as well as our planned phasing of strategic investments in R&D and SG&A throughout the year. Our gap EPS for the quarter was 42 cents, primarily driven by the California R&D tax credit impact. A full reconciliation between our GAAP and non-GAAP measures, including adjusted EPS and other items, is included with today's release. Moving on to other elements of the P&L. For the second quarter, our adjusted gross profit margin was 77.6 percent, flat compared to the same period last year, driven by foreign exchange headwinds offset by lower manufacturing expenses foreign exchange reduced our second quarter gross profit margin by 70 basis points compared to the prior year we now expect gross profit margin to be at the lower end of our full year 78 to 79 percent gross margin guidance driven by the impacts of foreign exchange through our hedging program SG&A expense Expense in the quarter was $561 million, or 32% of sales, compared to $502 million in the prior year. This was in line with our expectations and reflects continued investment in resources to support patient care, as well as a higher translation of our OUS expense base from the weakening dollar. R&D expense was $279 million in the second quarter, or 16% of sales, compared to $276 million, or 18% of sales, in the same period last year. This decrease in R&D as a percentage of sales and increase in total expense reflects our growing revenue and strategic prioritization of investments in our expanding Structural Heart portfolio. We continue to expect R&D expense as a percentage of sales to be approximately 17% in 2026. Second quarter adjusted operating profit margin was 30%. Our first task operating margin benefited from the planned phasing of strategic investments in SG&A and R&D during the course of the year. We continue to expect full year operating margin to be at the high end of the original 28% to 29% guidance, resulting in approximately 150 basis points of constant currency operating margin expansion for the full year. Going forward, we continue to plan for 50 to 100 basis points of underlying operating margin expansion while continuing to invest in the business. Turning to our tax rate, we now expect our 2026 effective tax rate, excluding special items, to be at the high end of our previous range of 16 to 19 percent. This reflects an expectation that side-by-side safe harbor taxation legislation alongside Pillar 2 does not come into effect before the end of the year. Our tax rate is also impacted by changes to California law permanently limiting the usage of R&D credits. Despite these incremental tax headwinds, we remain on track to deliver operating margin expansion and leveraged EPS growth. If legislation is passed before year-end related to Pillar 2, we would expect to see a benefit to this rate. Foreign exchange rate changes in the second quarter increased reported sales by approximately $15 million, or 110 basis points versus a prior year which was six million dollars higher than our expectation on a constant currency basis sales in the second quarter were near the top end of our guidance range if foreign exchange rates were to hold at current levels we estimate foreign exchange to be a second-half headwind of approximately 35 million dollars compared to the prior year turning to the balance sheet, we continue to maintain a strong and flexible balance sheet with approximately $2.9 billion in cash and cash equivalents as of June 30, 2026. Edwards' disciplined approach to capital allocation remains unchanged as we continue to support growth and create long-term value for patients and shareholders. Our highest priority remains investing in organic growth opportunities and strengthening our manufacturing network. Next, we look for external opportunities within Structural Heart where we can create value by applying our unique innovation strategy to address large, unmet patient needs. Finally, we will continue to be active in returning capital to shareholders through opportunistic share repurchases. Edwards has approximately $1.5 billion remaining under our share repurchase authorization. Average diluted shares outstanding during the quarter were $578 million. We continue to expect average diluted shares outstanding for 2026 to be between $575 and $580 million. Now let's turn to our Q3 guidance. For the third quarter, we're projecting sales of $1.63 to $1.71 billion. From a modeling standpoint, as expected, Q3 underlying sales growth will be artificially lower than our first half performance, given the high bar that our 2025 performance set for the second half. On a sequential basis, we expect normalized seasonality in Q3 this year. We are expecting adjusted EPS in Q3 of $0.71 to $0.77. The strength of our first-half performance and the strong fundamentals across TAVR, mitral, tricuspid, surgical, and our regions gives us confidence in delivering on our increased outlook for the rest of the year and targeting 10% sales growth on average longer term. And with that, I'll hand it back to Bernard.

Thanks, Doretta. So, in summary, our second quarter performance underscores the strength of our focus strategy and reinforces our confidence that the investments we are making today will drive sustainable growth and meaningful value creation over the long term. before we move to q a i also like to highlight two upcoming opportunities to engage with our team we will host an event at the tct conference in san diego this fall and we will also host an annual investor conference on december 4th at the new york stock exchange additional details for both events will be provided and we hope you can join us with that i will turn it back over to GRN to facilitate Q&A.

Thank you, Bernard. We're ready to take your questions. As a reminder, please limit the number of questions to one plus one follow-up to allow for broad participation. If you have additional questions, please re-enter the queue and management will answer as many participants as possible during the remainder of the call. Diego?

Thank you. And to ask a question, press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Please stand by while we pull for questions. And your first question comes from Robbie Marcus with J.P. Morgan. Please say your question.

Oh, great. Thanks for taking the questions. Congrats on a great quarter. And two for me, I'll just ask them both up front, both revenue driven, TAVR and PMTT focused. First on TAVR, clearly a very strong quarter, it appears you're getting the benefits of market expansion from asymptomatic and some competitive wins from your main competitor. The share seems to be shifting over. I'd love if you could dive into those two and talk to the trends you're seeing on competitive share shift, market expansion, and, you know, if you want to throw in how different U.S. and outside U.S. growth was considering the focus there. And then on TMTT, my guess is it's all the products, Pascal and Evoke, that's driving the upside. But if there's any one that contributed more aggressively to the 7% sales fee versus consensus, I appreciate it in color.

Thanks, Robbie. And great to be with all of you. So allow me to start with a very brief comment about, you know, the company performance. We are, you know, very excited about it, very pleased, you know, better than expected. and this is reflecting in our strategy. Our strategy in structural art is working very well. I want also to recognize our team who is having flawless execution globally. We have seen in Q2 and even in Q1 this year great performance by therapy and in each of our regions. So again, all of this give us confidence. So back to your question about TAVR. I would say on TAVR, a little bit of the same, better than expected. And these results are not happening by chance. They are the result of years of technology advancement, you know, about 20 years, you know, building world-class evidence, all of these together as, you know, position Sapien as the benchmark TAVR platform, you know, globally, with regards to value performance and value durability. So it is why, you know, it is important, you know, for us to always, you know, step back and look at, you know, why the results. And we believe that because of this, our results are durable. Now, if you want to compare, you know, U.S. to U.S., our growth rate in TAVR were very similar between U.S. and U.S. and they were the result of this renewed focus on TAVR given all of the clinical data we have produced in the last 12 months and many years. So that's probably what I want to say about TAVR. I'm sure Dan later will be able to provide more details. On TNTT yes, I think the value of the portfolio is now clearly in action. We have seen Pascal doing very well with an increased adoption also in U.S. and in Europe because of its differentiated feature. Evoke also have seen an acceleration and is doing very well. And then three is also having some, even though it is early, it's going very well. We got very good feedback from European physicians and U.S. physicians. So the beauty of this quarter is it is all together. And again, here I'm sure, you know, Devine, you know, later today, you know, we provide, you know, more detail about EMTT. So thanks very much for the question, Robbie.

And your next question comes from Larry Beigelson with Wells Fargo. Please take your question.

Good afternoon. Thanks for taking the question. I'll echo my congratulations on the really strong quarter here. Bernard, just, you know, one on progress and one high-level question for me. So, Bernard, on progress, can you talk about why you highlighted the heterogeneity of the progress population in the press release and in your prepared remarks? And, you know, if progress is positive, how would you frame the impact to your TAVR business, you know, relative to earlier new indications like asymptomatic?

Thank you, Larry. And let me start about, you know, first, you know, why we decided, you know, this time to split, you know, the progress presentation in two. The baseline characteristic at New York Valve and the full presentation of the result at TCT. We did that because a little bit of a learning from early TAVR. When you study a disease in eight minutes of a presentation, it is very difficult for a physician to provide everything. What the study design is, you know, why we did it, you know, the baseline characteristic and then the results and so here you know given the importance and given the learning from early time where we say it was probably important to speak it in two so we went a little bit deeper into hey you know one is potentially the size and what we have you know presented in your valley that moderate is at least as big as severe some analysis issuing even bigger this population is very diverse, very complex, and so we thought it was important, you know, in advance so people understood, you know, this disease. We also, you know, talk about the fact that there is no difference in age, you know, between the severe and moderate AS. But ask a little bit about, you know, what we wanted to achieve here. Maybe Dan, you want to add, you know, a couple of things on that?

Yeah, I think you covered it largely. I mean, it's the first randomized trial looking at the treatment of moderate AS patients and the heterogeneous nature of this population is not well understood and I think, you know, understanding the baseline characteristics a little bit better give us a greater insight into that and just help us understand when we get to digest the results of TCT later this year, just help us focus on what those results really mean. And so, you know, as you well know, Larry, this is a trial studying moderate AS patients with at least one at-risk feature, and I think it was important to describe what they are. And that population is, you know, at least in the literature anyway, suggests that it's representative of about 50% of the total moderate population, so it's still a large population And so, you know, this is, you know, we shouldn't be surprised by it, but, you know, maybe some people were. Maybe some people don't understand that the severe AS patient population and the moderate AS population are very similar in terms of their age. In fact, there's, you know, again, the literature on prevalence suggests there's only a one-year gap between severe and moderate. And so all those sort of details come out in the baseline characteristics. and then, you know, again, it allows us to sort of answer those questions and then focus on the results when they drop at TCT.

Yeah, and with regards to impact, you know, Larry, you know, think about, you know, that the practice of medicine is moving, you know, slowly. So we expect, you know, minimal impact in 2026, and our long-term guidance for TAVR, you know, mid to high single digit, is here to accommodate, you know, all of these kind of scenarios. What we will do at Investor Conference is provide, you know, a more, you know, detailed guidance, obviously, you know, for 2027. Thanks for the question.

Well, I just – thanks for that comprehensive answer. But I wanted to ask about your comments about 10% total company growth on average, because you didn't highlight that on the Q1 call. And, you know, the implied second half underlying growth is about 9%, you know, which is slightly below 10%. So, I know it's really early, but, you know, do you believe you can grow 10% underlying next year, and if so, what are the drivers?

Just to be clear, Larry, my comments on 10% is about the company, and it is a guidance comment long-term about the company with TAVR growing between mid to high single digit. I think, you know, this was our comment that we did at Investor Conference, and it was the same comment that we did at the end of the Q1, and the same, you know, I did, you know, today.

I got it. I meant the total company, Bernard. Sorry if there's any confusion. I was asking about total company, not CAPR, but I'll leave it there. Thank you.

Thank you.

Thank you, and your next question comes from Travis Steed with Bank of America. Please state your question.

Hey, congrats on a good quarter. This maybe was a follow-up somewhat to Larry's question. Given the tough comps in the second half, you mentioned you still expect normalized seasonality in Q3 this year. I just want to make sure I understand what normal Q3 seasonality means. Looking back at the model in worldwide tavern, kind of down anywhere between 15 to $30 million sequentially from Q2 to Q3, which to me, my math puts that at kind of 5% to 6% worldwide I'm curious if that's kind of the math that we should be doing or you'd say anything on the seasonality.

So maybe, you know, let me try, you know, to put in perspective of how we think about the guidance for 2026. First, you know, we had a better than expected, you know, first half, you know, Q1 and Q2. So we took this sustained performance into consideration in rising our full year guidance. In addition, you know, what we talk about, you know, in Q1 and today is the fact that we expect, you know, the second half growth rate to be artificially low because of the high comps, you know, from last year. I don't know if you remember, but last year, you know, the summer was, you know, very high, you know, from the growth rate. So we have a very high comp 2H of 2026. And we took all of that in consideration, you know, to give you the guidance you know, 10 to 11 for the total company. So is it good enough here, or do you want more detail on this guidance and 1H and 2H dynamic?

Yeah, there was a comment in the prepared remarks about normalized seasonality in Q3, and just wanted to make sure we had that down.

Yeah, so this year we didn't expect, you know, like last year, You have a very strong summer, you know, basically. And what you are going to see is basically, you know, Q2 to Q3. You are going to have some incremental dollars, you know, Q2 to Q3.

Thank you. And then kind of the second question is more on the NCD. I don't know how big of a deal you think NCD is on kind of TAVR growth next year or how to quantify how many centers this opens up or does it open up capacity for TMTT as well as TAVR just anymore on the NCD? now that it's kind of more finalized.

Maybe I'm going to ask you to Dan to comment on the NCD itself and then we can discuss about TMTT.

Yeah, thanks for the question and it's an important one. First of all, we're really pleased, right, that CMS is running this process and the good news is as we get nearer to the end of it, you know, we've just seen a draft policy position and the second comment period, the second public comment period is now closed. And so final policy memo is expected in September. And so this is where we are in the process. When you look at that draft, there are a couple of opportunities there. We're encouraged by it, number one. I think that's really important to say. And I look at it in three different ways. right, you know, the big reasons to sort of like open this up and revisit it, the first one is, you know, we're encouraged, at least in the draft, it says that there's a pathway for asymptomatic, you know, indications to be covered, that's really important, that's one opportunity. The second is that there's a recognition that after all these years that symptomatic severe aortic stenosis is a reasonable and necessary procedure for Medicare beneficiaries and that it can be covered without, you know, evidence development and that's super important. And then the third is modernization of the policy around empowering heart teams to give timely access to care for patients in need. And so these are the big ones that, you know, present what we would say tailwind or potential catalyst as far as future opportunity in 2027 and beyond. Your comments specifically about new centres, if you think about it, the current draft policy states that cardiac surgery programs still need to be in play and exist for a TAVA program to be covered or TAVA procedure to be covered. And so if you think about that, where we are, about 850 odd plus centres and how many surgical centers, you know, there's room for some expansion, but that's not the big, you know, the big ad. The big ad will be, you know, how efficiently patients can be processed, referred, diagnosed, referred and treated, and what that means from a program efficiency perspective, and that will be very, very important as demand we anticipate to continue to increase based on indications and evidence.

Great.

Do you have a follow-up question?

No, that was it for me.

Okay, thank you.

Thank you. And your next question comes from Joanne Wuench with Citibank. Please state your question.

Good evening, and thank you so much for taking that question and for delivering the quarter. So we're getting a lot more questions on progress, and I was curious if you could sort of level set, assuming that the clinical data looks good, how you think the adoption rate might be and how do you think the steps would be towards having that contribute to revenue? Thank you.

Yes, I'm going to let down, you know, take this one.

First, we can make a whole bunch of assumptions. I think, like, you know, the first thing is we have to see the results, and those results will be, as you know, presented, published at TCT this year. But if I, you know, taking a step back I think we need to think about this patient population in a very similar way as the asymptomatic patient population. These are new indications that don't have a predicate, right? We spent 15 years doing a lot of evidence generation on TAVA as an alternative to surgery. And whether it be an asymptomatic patient population or a moderate disease patient population, the guidelines are not in, you know, are not...surveillance is the recommendation for these particular indications, not surgical intervention. And so there's an element of change management and human behavior change and education, et cetera, that has to go along, you know, with any of these new indications or new data sets. And so I think that, you know, we can look at that very similarly. I think it's going to be important data, there's going to be a lot of learning, but we can think about those two things in a similar way relative to say, you know, high risk, intermediate risk, low risk, where it's just a, you know, against an existing predicate. Does that make sense, Joanne?

It does. Thank you so much.

Thank you, Anne. Your next question comes from with Deutsche Bank. Please see your question.

Hey, good afternoon, guys. It's interesting to take the questions in a great quarter. I'll ask you questions up front, looking at Pascal Tricuspid with the approval expected in the fourth quarter and receiving the data at TTT in the fall. Is it safe to say that the trial is any color there? And then the follow-up is with market share gains you've seen in my actual with Pascal. Can you talk about how you think you're positioned to enter the Tricuspid market with Pascal?

I can tell you, you know, we are very pleased about, you know, the Pascal performance. But I'm going to let, you know, Devin, you know, provide, you know, more detail. It's very close to it.

Yeah, thanks, Bernard. Thanks for the question, Pito. Yeah, as you said, exactly, you know, right now we're expecting both the data to be released at TCT this year. I think we'll all look at the data together, and our expectation is for a Q4 approval in the U.S. is our current planning right now. If you look at Pascal Tricuspid, however, so far, you know, we've had this technology now in Europe for a few years, And we see that some of those differentiated features with the Pascal device on the mitral side come off even more so in the tricuspid side. So physicians can see that some of those cool features about independent grasping, et cetera, they really make a difference in treating their tricuspid patient. And as a result, we see that physicians want to use Pascal more and more often in the tricuspid situation in Europe. So I think it's on the back of that as we think about the U.S. tricuspid approval and launch as that next layer of growth, as that next wave of potential growth for the TMPT business where we think that those differentiated features should be able to come over to the U.S. We've got a large number of physicians who were in the trial, were in the continued access for the trial as well. And I think there is that kind of, you know, looking forward to this technology coming and helping their patients here in the U.S.

You know, what we like with this, you know, Pascal Freight Speed, you know, upcoming approval in the U.S., this is adding a layer of growth, you know, for TMTT. So we have today Pascal Meichel, you know, we have Evox still scaling, we have M3 at the beginning, and we are going to add, you know, this fourth, you know, layer of growth, you know, for TMTT. So these give us confidence. One is that physicians will have all of the tools they need, best-in-class tools they need to treat their patients, but also, you know, confidence in TMTT achieving $2 billion in 2030.

Your next question comes from Vijay Kumar with Evercore ISI. Please state your question.

Hi, Bernard. Thank you for taking my question, and congrats on a nice sprint here. Bernard, it looks like in the press release, you've caught up e-book. I'm curious on this PMTD performance. Have you seen an inflection in e-book, and is that what's driving the strength, or is this more broad-based when you look at the PMTD portfolio?

Let me make a brief comment about it, and then I will ask you, Devine, to add, you know, additional color here. I would say, you know, we have seen an inflection in e-book since the beginning. The demand is very high, and, you know, so it's like, you know, it's growing, you know, very well. And, you know, what we have seen in the quarter is, you know, great adoption. But I'm going to let, you know, Devin, we're very close to this action.

You know, I think I'll speak first a little bit more broadly. As Vera mentioned up front in the call to Ravi's question, you know, we've seen a growth coming across all of the platforms in TMTT and, to be honest, all the regions for TMTT. It's been great to see that all the technologies are adopted. As you can imagine, you know, right, Pascal was our first technology, so it's actually our largest technology by revenue. And Evoke, though, is second in size but growing very quickly. There's a lot of excitement for the technology. We see the continued new data coming out, people adding to the overall clinics portfolio that makes people want to use Evoke. And then we've got the new kid on the block, obviously, with safety in M3, which is the newest high growth rate but the smallest because it's just the newest in terms of its timing. And what we're seeing overall is that it was specifically, if you dive a little into the Vogue, we see a couple different factors. We see a kind of deepening overall adoption coming from, you know, we have new centers opening up every week, every month across the world. So new centers are getting exposed to Vogue. We see that in existing centers. Over time, we're continuing to work closely with them to streamline the whole process of an Vogue patient, from the pre-case plan to getting ready for that patient, to actually executing the case. And that then enables those centers to actually do more cases and actually increase that kind of amount of usage in each case. So I think those together are helping keep the momentum going in a boat, but I don't want to underscore the momentum we see today both in Pascal and the initial momentum we're seeing with M3.

That's helpful to me. And maybe Bernard, one on progress. I know there were a lot of, you know, heterogeneous populations, and you guys did a good job trying to balance out the different factors. Most of these patients had, you know, heart failure symptoms. Were the baseline drugs in this trial, was it a consideration when randomizing? I don't know if you can answer that, but if you could talk about how drug arms in both arms, how the drugs in both arms were, whether they were randomized or was that a criteria?

You know, thanks, VJ. I'm going to ask, you know, Dan to reply to this way. It is a technical question, VJ, so Dan is with the best position here.

I think it's, you know, and I think this is one of the reasons why we presented the baseline characteristics and perhaps, you know, it's important for everyone to understand this is not a heart failure trial, right? This is a trial on moderate AS patients with at-risk features. UNLOAD was a heart failure trial where the patient happened to have moderate AS and so these are two very, very different patient populations. And you could see, you could see from the baseline characteristics what's interesting about them is, you know, perhaps clinically not benign, we'll see, like, you know, these patients did have symptoms, they did have at risk features as the trial design was intended but they also had very healthy left ventricular function. And so, you know, this is the type of patient that we're dealing with, they're not a heart failure patient. They're a moderate AS patient with certain characteristics that may predispose them to greater risk clinically than what current guidelines suggest, which is active surveillance. And so, again, a lot of learning here, understanding the patients, you know, so, you know, drug regimes don't play into a big factor here because these patients don't have heart failure symptoms, although the primary endpoint is going to include hospitalization and heart failure events, obviously when you're doing a surveillance trial like this, a comparator against surveillance like this. So a lot to learn, and we'll learn more when the results are presented at TCT. Thanks for the question.

That's helpful, thank you. Your next question comes from Josh Jennings with TD Cowan. Please state your question.

Good evening. Thanks for the questions. First, I just wanted to talk about Tavern Market Growth Trivers and the CMS NCD update and the Modern Indication are two clear ones. Tavern and Tavern is kind of going to pump in on the back burner, but the worst indication was approved in 2019, so next year will be the eighth year post-approval. Edwards hasn't been very vocal about Tavern and Tavern as a potential driver with shaping his well-positioned for that procedure. Maybe can you help provide some insights on Edwards' internal expectations for the Tavern and Tavern opportunity and when these procedures could potentially contribute at a meaningful level to volume growth?

Maybe, Josh, maybe I answer that question. You're absolutely right when you talk about some of the more obvious sort of milestones ahead of us with NCD progress, et cetera, and lifetime management, I think we've talked a lot about this. This is something that is becoming absolutely more important and more critical, particularly as the evidence suggests that you get benefit by treating earlier in the disease pathway, not just younger. I mean, earlier in the disease pathway, as we learn, can mean different things to different patients at different age groups, but the reality is is that we anticipate as more as the therapy penetrates is that there are going to be patients who outlive the durability of their valve, and we're seeing that in various trials, et cetera, in various patient populations. And so lifetime management comes a thing in the planning of when to treat with what option and how to treat the second option, and there's a lot of complexity in there. So we have modeled that in to our market model. You know, we look at that. Right now, it represents a relatively small part of the market, relatively. We anticipate that to grow. And that's all factored into the TAVR market.

You know, if you put all of this in perspective, we are, in my mind, sitting in front of an amazing opportunity. If you look at TAVR, you have – it is still underpenetrated. It is still underadopted. We have, you know, the asymptomatic indication to unlock with the NCD. The NCD has the potential, if the trust remains like it is, to streamline timely access, you know, for patients. You have, you know, if a study is positive, a progress study is positive, another, you know, indication for this patient population. So we look at TAVR as a very durable growth engine, you know, for the company. You add, you know, all of the catalysts we are having on TMTT, Pascal, M3, Evoque, and you look at surgical also, you know, we didn't discuss about surgical today, but, you know, we have also, you know, many opportunities in surgical. So all together, you know, for TAVR and all together for the company, we feel very confident. You look at, you know, what we did last year, you know, what we are doing this year, the kind of execution we are having also, all of this together in my mind, And it was going to give us confidence in about achieving long-term about 10% EPS leverage and operating margin improvement, you know, 50 to 100 points. So, again, excited, confident. I like, you know, what the team is doing, and it's great to be able to report to this kind of quarter.

And, ladies and gentlemen, that's all the time we have for questions today. I'll now hand the floor back to Bernard Zorvigian for closing remarks.

Yeah, so thank you all for your interest in the company. You know that we are available for any call, you know, the director, Jair and Sine and myself are available and I know that you are going to have, you know, phone call with the Thank you so much and have a great day.

Thank you. And with that, we conclude today's call. All parties may disconnect. Have a good day.