All right. Good morning, everyone. Thanks for joining us today. Very, very pleased to host Edwards Lifesciences. This should be a fun event. I guess, to start off with, before we start asking questions, do you want to have any sort of opening statements, or should I just get right into this? No, let's get into it. Good morning, everyone. It's great to be here. I'm glad you have an interest in the company. We are very pleased about all what we do. We take care of patients in the best way possible. We are very proud of the impact we are having. The good words, it is evolving from basically predominantly a TAVR story for the last four decades into TMTT, which is increasingly being a bigger part of your growth algorithm. I guess, from a bigger picture, how should investors think about sort of the vision of the company, the change in composition, sort of in terms of TAVR, TMTT, PASCAL, EVOQUE, also U.S., OUS as we think about sort of your long-term growth rate in the next sort of three to five years? Yeah. Thanks, Pito. Let me start with a couple of comments. One is Doretta, our new CFO, has been with us two months now. She's an amazing partner. She gets the strategy of a company, and she's fully on board to enable this strategy and to accelerate this strategy. Let me talk about strategy very quickly. What I love about this company is we have strategic clarity. It is all about structural heart disease. It is a very large space. There is a lot of unmet patient need, and it is growing. As a company, we spend a lot of time on execution. The entire leadership team, which is a rather smaller leadership team. Everybody is deep into structural heart disease, and we deliver flawless execution. You have seen that. Finally, you have a culture of a company. There's 17,000 employees. They know that it is mission-driven. They know it is about their patients. Every day they wake up, and they are motivated to make a big impact. These three things together basically have resulted in what you have seen. Top-tier performance. Top line, bottom line, and us being predictable, having durable performance. Now to address specifically your questions, Pito, you are right. The way we are thinking about the company today is mainly five therapy areas. All of them in leadership position, all of them with many catalysts. You have TAVR AS, you have PASCAL, you have EVOQUE, you have SAPIEN M3, and you have surgical. This gives us this reach of scale to be confident short term, to be confident long term, and to be able to be confident about durable top-tier performance as a company. Since the second quarter results, the NCD has come out. You guys know I have been very excited about this NCD for quite some time. It has been a pretty good debate within the investor community over the last year and say three months as we have been talking about it. Some doctors at large volume centers had different views, the impact versus doctors at lower, small community centers that we have talked to in the last few weeks. I was wondering if you could help guide investors how we should think about the NCD now that we have it in hand. In terms of new centers, in terms of utilization within those centers, high volume, low volume, or any other areas of benefits that we should be thinking about. Thank you. The news last week was very positive news for patients, for the field, and for the company. CMS, after 15 years of a ton of evidence, physician experience, great patient outcome, and this technology being one of the most proven, one of the most studied, declared that basically it is now reasonable and necessary. Which is a big step, if you think about it. We look at the NCD along four key elements. The first one is about providing flexibility. Flexibility at two levels. One is around the patient access. In the past, the former NCD, the patients for an evaluation had to go twice to the hospital and see a surgeon and a cardiologist. Today, there is only one on-site, face-to-face physician visit. The other one could either be done through a remote kind of visit. That is providing the patient who are very sick, all patients, an easier access to being evaluated for TAVR. Also an additional flexibility at the point of treatment. In the past, it was mandatory to have a surgeon and a cardiologist in the room during a TAVR procedure. It is not anymore the case. One is mandatory. One operator. It could be a surgeon. It could be a cardiologist. What CMS has done very well in our mind is it provided the opportunity to the heart team to decide. If they want to be two in the room, they can, and both physician will be covered. In my mind, this is extremely well done in a sense that it will protect high quality of care. It is empowering the heart team to decide what is best for the patient, but also it is streamlining the processes where it is necessary. That is about flexibility. The second element is about volume requirement for a hospital to have a TAVR unit. In the past, for a hospital to have a TAVR unit, they had to have a certain number of procedure per year. It is not anymore the case. The operative requirements remain the same, which is very good, again, to maintain excellence in care. This will provide an opportunity for some cardiac surgery centers who do not have a TAVR unit to open a TAVR unit, and it will happen in cardiac surgery center only. It is mandatory in this NCD. Here an opportunity here to increase patient access across the U.S. The third one, also very important, is now asymptomatic, is covered with CED under this NCD, so it is an additional patient population will be able to receive this very proven therapy. The fourth one, also very important, it is providing a pathway for upcoming FDA approvals, new indications. What we need you all to step back and think about is, NCDs are more of an exception and MAC coverage is more of a norm. There are only a few hundred of NCDs, 300 or so, and thousands of technologies are covered for MAC. What CMS has done here is clearly providing guidelines that for upcoming FDA approval, the MAC will be very well-positioned to cover these new indications. If you think about all together, it is empowering the heart team. It is maintaining excellence of care, at the same time, providing flexibility in term of access to care, in term of at the treatment, at the point of treatment. All of this very positive, very well done, all thinking about, at the end of the day, the patients that need the best care. Just to follow up there, on your second point, changes the point of treatment. How should we think about how many new centers exist out there today that have these sort of cardiac surgery centers? How many do you guys think will be opening because of this change of NCD? How do we think about the smaller volume centers today that exist, that have had issues with staffing, that only having one doctor in the room helps scale them up. If you can just help us quantify new centers and also increase capacity in the smaller centers as we think about how this could increase? Yes. The drain from the urban guys that are already slammed with a lot of things, helping basically spread out some of the demand. Let me start with potentially the new centers. There are about 1,100 cardiac surgery centers in the U.S. and about 850 TAVR centers in the U.S. The difference between these two numbers is the potential of this cardiac center opening a new TAVR unit. I do not believe all of them will do. My guess is some of them will do that. It will be a decision between the physician, the administration at these centers, also looking at the patient access gap or need happening in this region, in this town, in this city. So it could be 100, it could be 200. It will take time, though. This hospital will have to make their decision, get an approval. Our team will be ready to train them and do TAVR for sure. But our guess is it is going to take time, it will happen over time. It is also a positive if you think about it, because at the end of the day, what do we want? We have worked very hard in the last 15 years to build something very special with TAVR. And we want to make sure we maintain that. So excellence of care is very important, and we are ready to train all of these centers. That is the first part of your question. The second part of the question is about how much this flexibility is going to help low-volume centers. It is a good question. I say it is going to be team-dependent, hospital-dependent, but it has the potential to help. When now you have the flexibility. So let us take a few example. If it is a very easy TAVR case, one single operator is most likely going to be sufficient, and the heart team will decide. If it is a complex case and the heart team decide to have a surgeon and a cardiologist, they can do that. If it is not necessarily a well-experienced operator and they want to be two, they can do that also. So it is full flexibility to do what is best for patient care. So I believe it is going to help. Yeah. I think the beauty of everything that Bernard just talked about is these are all multi-year opportunities. You may see some impact more shorter term when we talk about flexibility. Some centers may adopt that flexibility right away. Others, it may take a little bit longer. Opening centers may take a little bit longer. You are not necessarily going to see a huge peak and then a valley, but what you really have is the pathway and the confidence in having a durable long-term TAVR growth rate that we have been talking about of that mid to high single digits. It is interesting. We talked to doctors, say, in Kansas City that were in the trials, and their volumes basically hit peak 10 years ago and have not changed since then. They said, "10 years ago, I was the only one there, and now there is six." This kind of will keep opening up more capacity where for those guys, we talked to other centers down in Dallas that have had issues staffing, and they have three TAVR centers and their volume is at flat because of issues staffing. I just think about capacity issues. This could be 20%, 30%, 40% increase of capacity of the simple cases because the complex cases you will keep sending in. But this has over the multi-year time period, especially as these doctors get more and more demand from mitral and TMTT. There is just demand, and you want to ship it out because these doctors take a long time to train. No, you are right. It is why this NCD, very well thought out. CMS has done an amazing job listening to all stakeholders, cardiologists, surgeons, industry, societies, patient group. In my mind, it is truly very well done because this is going to be the backbone of this TAVR therapy for the next 10 years. Basically, I am assuming that all of the heart team are going to look at this one and use it to their advantage. Whatever their opportunity and challenge are, they are going to use it to challenge themselves and make it better. They are empowered to do that. Yeah. The last point is where it goes into the innovation that you've done over decades. SAPIEN initially was incredibly hard, and now today it is simple, and that's what it's known for. This is going to expand capacity significantly as demand keeps on increasing. No. Think about it. I love what you said, Pito. Think about what it is today. For most of the cases, you have a patient getting to the hospital the night before, getting a TAVR in the morning, leaving the hospital that night, being able to have a normal dinner that night, with family, kids, grandkids. The complication rate with the SAPIEN platform is very low. The performance is best in class, and the durability best in class, is the most durable one at seven years. We know that now. So think about the impact to these patients. We'll get into that durability in a second. The second-biggest question I'm getting the last few weeks, and we've done a lot of doc calls, and we're hosting an event next week to try to figure this out, is obviously the PROGRESS trial. Which is one of the most exciting catalysts, I think, in MedTech sort of in 2026 and in 2027 and probably beyond. I guess one of the questions that I'm getting a lot is how do we think about the impact of the [catro], like the identity versus the TAVR unload in terms of the trial designs and how clinicians think about a positive outcome with that aspect of the trial? What's a home run for you guys on this trial? What is a good trial result? How do we think about the sort of the TAM implications within both home run, good results, sort of with this aspect to sort of trial design? I get this question a lot, as you can imagine. No. Almost multiple times a day. Let me give you a few points that are very important. One is the study you mentioned. It is a different study. It is a heart failure study with some moderate patients, so very different than MODERATE and PROGRESS. When we started the trial five, six years ago now, we started the trial because we know well aortic stenosis. We know it is a deadly disease. We know it is a progressive disease. We had a belief then, and it is still the case today, that treating this patient earlier, before the progression happened, makes sense. This was the belief, this is how we designed the trial. We were pleased to see how fast the trial enrolled, which is always a good indicator when physicians see that it is in their own patients. Again, it is a small sample size that yeah, no, it is working not too bad. Having said that, I do not want to speculate. We are very close. We are six weeks from an important trial result at TCT. I do not want to speculate on what it could be, what are the risks, how big it is. We know that it is a big patient population, the moderate patient population. At least as big as the severe patient population. Yes, this was our belief. It is still our belief. I encourage all of us to be patient for six more weeks. It is going to happen fast. The good news is all of that is also part now of the new NCD. I do not want necessarily to be back to the new NCD, but I think it is important. The new NCD is going to help with severe symptomatic patients, with all of the flexibility we talk about and all of this. The new NCD is also now covering asymptomatic, which is a patient population, also large and uncovered until last week. There is a pathway for moderate if we get an FDA approval. If I can ask it differently. How should I think about the TAM between the symptomatic and asymptomatic moderate AS? I ask because some calls we have been doing in the last month have been talking, some clinicians have been actively treating moderate symptomatic patients because there is some fuzziness within the guidelines with very good results. I am curious if I think about from, depending on how the trial results go, that will be a very easy population to turn on. As I think about the moderate size, what percent of the population is symptomatic versus asymptomatic are you seeing? It is very difficult to know. I know everybody wants detail. It is very difficult to know because I use this example all the time. When we started the TAVR journey 20 years ago, we thought, everybody was telling us at the time, we are treating all patients, all AS patients. This TAVR opportunity is going to be, at best, very small. Then we said, "Maybe it could be a $1 billion opportunity." To date, it is a $7 billion opportunity. When you do not see the patient, when you do not treat the patients, it is tough to assess and understand. I know everybody have some prediction, some belief. They are usually wrong. The study is going to help us. Again, what you need to think about, it is why we presented the patient characteristic, is that this study is studying only the most severe moderate patients with one at-risk factor. This is what we will know out of this study. The only other thing I would add is, it has been so many years, right? Still penetration within our existing population is still only in the low teens. Even the market opportunity, asymptomatic, moderate, could be additive, but there is still so much opportunity within the market itself. Switching to international markets for a bit, both developed countries like Europe and then emerging countries. What is your view of the balance between deep clinical research that you guys have had for decades at a premium price point, versus sort of lower cost products that have been coming out kind of with less clinical data? What are you seeing in terms of market share, market growth within both the developed and underdeveloped as you think about those sort of different ways of selling these devices? Yeah, that is a good way to think about it. I would say the opportunity is probably even bigger outside of the U.S. To Doretta's point, if the adoption in the U.S. is in the low teens, outside of the U.S., it is even lower. So we have an even greater opportunity outside of the U.S. Like you have seen lately in our results, we are doing equally well in the U.S. and outside of the U.S., despite having way more competition outside of the U.S. Some of the technologies are not, for sure not, at the same level than our SAPIEN platform. I like our position. Having a valve like SAPIEN, proven best-in-class performance. Very, very low complication rates, pacemaker stroke, and now benchmark durability. I like our chance here. It will be very tough. We are not talking about a commodity technology. We are talking about a valve in someone's heart who needs to beat for a long time. If I am a patient, I know which one I want. I trust the clinical community, in them making the best choices. It is why we are doing well, and it is why we believe that we are in front of a durable top-tier performance. Can we talk about the durability for a second? Obviously, the trial came out that was pretty favorable for SAPIEN versus one of your largest competitors. Doctors are often stubborn sometimes in terms of changing behaviors with sort of these type of studies. I guess, what have you seen from, what have you heard from your sales reps? What have you seen with the physicians in terms of speed of change, willingness to change because of sort of this study and frankly, some of the studies that have come out beforehand? Does it move the needle? Are they just going to stick to what they know? Are they open to hearing it? Does it take time? What is the speed at which this evolves, if at all? I will make three points. The first one is it's not going to go fast because nothing goes fast in medicine. The second one is we were pleased with our results, and it is not a surprise. We have been doing valves for 70 years. I think it is important to remind everybody the first mechanical valve 70 years ago, the first tissue valve 10 years later, the first TAVR 20 years ago, the first tricuspid valve EVOQUE three years ago, and the first mitral transcatheter valve this year. This is our domain knowledge. We do that for a living. No surprise here. It is not easy. It's very complex. The third one is we have seen in the last 70 years, many valve technologies coming and going. Companies were super excited by it at the time they launched it. It didn't last too long though. Just to give you the full framework, I think physicians are, I trust the clinical community. They are smart people. They go deep. Some of them are embracing the change faster than others, but they always do the right thing for patients. Okay. I trust them. Back to your TAVR penetration comment a few minutes ago. It was $1 billion not that long ago, and now it's $7 billion. What are the biggest constraints to patient identification and treatment that we're seeing today? How do we help evolve this? How does the NCD help within that aspect? I also ask because we had an interesting call the other day that this large system is now using CT scans. If the echo doesn't give a complete answer, they're using CT scans to scan, and that's increased the volumes of the center by 20%. There is still a lot to do, given where we are today, low TMTT penetration in the U.S. for TAVR. There is still a lot to do, and we are doing a lot. There are things that we do at the society level in term of education, in term of quality metrics, but also technology can help. I give you an example just to illustrate. It is not a TAVR example, but you can easily translate this example to TAVR. For each of the mitral and tricuspid patients, the heart team submit echo and CT scan of a patient to our team. We look at it, we analyze it, and we tell them what technology is best. PASCAL or EVOQUE, or PASCAL and SAPIEN M3, depending if it is a mitral or tricuspid patient. We used to do that very manually. More and more, we are embracing technology and AI. The turnaround is amazing, and we might have even better results. We can imagine a world where this could be part of our processes here, to analyze imaging and to provide the best care options to treat these patients. That's another example. Also, sometimes people in the hospital have an echo for a different surgery, and through this echo, they are detected having a severe AS, but they could be lost because they didn't come for this, all of that. AI can help look across the hospital to detect better these patients. I do believe that in the next five years, or even faster than that, we are going to see technology and AI helping with awareness, helping with diagnostic, helping with treatments. Switching to TMTT for a little bit. Your target's about $2 billion revenues by 2030. Can you just sort of bridge how we should think about sort of that $2 billion revenue between PASCAL, EVOQUE, SAPIEN M3, and what are the catalysts that we should be looking for within those product lines the next 18 months to help give us confidence in terms of achieving those targets? It's good. I will more and more internally, at least, we are thinking at TMTT having three therapy focus: PASCAL, EVOQUE and SAPIEN M3, and four growth drivers. PASCAL MR, PASCAL TR, because as you know, we are on track to get an approval for the tricuspid PASCAL in a tricuspid position before the end of the year, and then SAPIEN M3 and EVOQUE. All of them today are contributing to the excellent performance we are having, where we are on track to achieve about quarter of a billion, growing about 40% in 2026. When we gave the $2 billion in 2030, we gave this number a long time ago. I remember I did it. I was running TMTT. You know why? Because I was at the time getting a lot of question. TMTT is a tiny business. $100 million, I believe it was. How big are you going to be? We gave this number in our mind near term, $2 billion by 2030, just to give you a sense. But the vision is not $2 billion by 2030. Our vision is clearly to unlock the potential of mitral and tricuspid. There are millions of patients in need with no solutions. It is why we build a full portfolio to help physicians treat their patient in the best way possible. Even though everybody remember the over $2 billion, believe me, internally, it is not the number I have, because it's a way bigger number to be able to impact way more patients across these mitral and tricuspid segments. So way bigger over time. Over time. 2x, 3x, 4x. Way bigger over time. I am not going to speculate on the number. Let him go. Okay. I guess, any color on the $2 billion split between the product categories when you initially gave it versus where you are today. Obviously when you are planning, things happen, things evolve. Yes. Pascal has obviously had a fairly phenomenal rise versus the first few years. As you think about the $2 billion number you had before, what is the split between those three products in 2030, and how has that evolved in the last couple of years? The second question is, as you think about the $2 billion between U.S., OUS, is it still? How should we think about that evolution as well? I would say all of them, the four platforms that we discussed, are the four growth drivers, and U.S., OUS are performing very well. There is no one lagging, no one leading. They are performing very well. I can give you a little bit of flavor on each one of them, and see, Doretta, if you want to add anything. On PASCAL, for instance, this one is the most established one, where we started earlier, and it is seen as very differentiated, and it is impacting the space itself, where there is more and more patients now treated with TEER. So we are growing the market, and it is what we care the most about. For EVOQUE, it is a new therapy. So we are creating a new space, a new category, and it is going very well. We are opening new centers, and we are also increasing the utilization in existing centers. Both are contributing to the performance of EVOQUE. SAPIEN M3 is the very beginning, but it is following the same trend. There is a high demand in the U.S. There is a high demand outside of the U.S. So we look at all of this. These give us confidence. But the way we are, why are we confident and why are we pleased? It is not about selling a technology. We are not going to a physician and say, "You know what? With this technology, trust us, you can treat everybody." We are saying, "No, we are here to help you, and we have all of the solution you need to treat your patients." That is a different kind of a way of thinking. It is a different kind of partnership with physicians. This is what give us confidence. It is not necessarily, we are not looking at them in isolation here. But Doretta, you want to add anything? I think you said it very well. PASCAL, your OUS tends to be more established than here in the U.S., but I think the important thing is each of these drivers provide incremental layers of growth to our overall TMTT franchise. They're just in different stages of launches, different stages of development. Now to be more specifics about your question between three quarter of a billion now to $2 billion in 2030. Think about what's happening. You have PASCAL tricuspid approval before the end of the year. This is going to add incremental opportunity here. Then you have SAPIEN M3 being at the absolute beginning. The approval was earlier this year. These two by itself are things that we didn't benefit so far. Thinking about TR, there's obviously a question around mortality. Quality of life is obviously phenomenal. That's why this got approvals faster than anyone was expecting. How much interest do you see from physicians in terms of solving for quality of life? So much of what we solve for is mortality, and all of a sudden now we're solving for quality of life. How much interest do you see around that aspect? Within the TR, there's lots of debate on repair versus replace. You can punt on that. Finally, as you think about hospital economics for EVOQUE, what's your views around hospital economics, and is that maybe a constraint in order for future adoption within that class? Yeah, no, there is a lot to unpack here. It's a good question, both. I would say first, I'm sure you know, many of you have looked at the preview study last year. Clearly, the opportunity between tricuspid, mitral, and AS are equally important and probably equally in size. So big opportunity. Now, tricuspid, up to two years ago, physicians didn't have any options. So it is yet a disease to be better understood and a category to be developed. I compare it to tricuspid like TAVR AS 15 years ago, where we were discovering with the first PARTNER study. So it is probably the same in term of cycle and maturity, very early. One, so big opportunity, very early in the cycle. We have now two promising technologies, EVOQUE and PASCAL, and we have a competitive technology also. So you have three technologies as an offering to physicians. The beginning of some studies. What we see also is an evolution in the understanding of a disease. For instance, in Europe, the centers have started earlier. So you have larger centers who have done a lot of tricuspid cases, way more than in the U.S. as of now. And we have seen the latest study from Europe presented at ESC TRIC-I-HF, mostly German centers. No, all German centers. They were able to show a mortality benefit. So you see that the first experience, it was only quality of life for EVOQUE. Removing it of a crossover, we were able to show some mortality benefit, hard endpoint benefit also. But the TRIC-I-HF was able to show a mortality benefit in addition of quality of life. So there is a progression of understanding happening in the field. There is still a lot to do. There is still a lot to do in term of technology innovation, more understanding of the disease, more evidence and we are clearly going to be behind it, investing, and being very close to the physician community. Sort of regarding on that, when we talked to docs that were in the EVOQUE trials, they talked about how late they are getting into replacing the valves in many of the patients, and the speculation that they got there early, then the disease progression, that their mortality benefit would have been very clear. Is that what you guys are focusing on is basically by the time you are replacing these valves, the heart was already sort of in its final stages and therefore, it is hard to change mortality whereas get it early, it would be a much easier time period in order to show the mortality benefit. The field is learning a lot as we go, and I am pretty sure that in a few years from now. It is the same comment, I believe you made, Pito, earlier in this conversation. Remember TAVR where it was a few years ago. And here it is the same, and we started from a better base with EVOQUE and with PASCAL tricuspid, all of this. So, for sure we apply the learning from TAVR and from the past, but this is still Gen 1. This is still the beginning. Yes, it is going to evolve. These patients, when you look at them, and I meet a lot of them, they are in a terrible condition. Their quality of life is terrible, and I have met so many of them who received or a PASCAL or an EVOQUE, and they have a different life today. No, there is promise, yeah. Doretta, I am going to drag you in here now and talk about some exciting balance sheet capabilities. How do you rank internal R&D, tuck in M&A, large strategic transactions, share repo? What therapeutic apps do you guys think that you are missing for, to take those investments externally? Almost most importantly, as you guys sort of return to this company with substantial cash flows, what is the right leverage ratio that Edwards should be running at as larger and larger transactions become, frankly, harder to do? Should you guys be bringing leverage up and increasing share repo to investors? Yeah. We are in a very fortunate position to have a flexible balance sheet. That being said, we want to continue to be disciplined with how we think about capital allocation. Our first priority, very consistent with what it has been historically, is to continue to invest in our own internal capabilities, including our manufacturing network and how do we bolster our internal business. Secondly, it is about how do we find additional opportunities. But we want to be thoughtful about that. We have said we have a clear strategic focus, which is in structural heart, and what makes us successful is being able to get involved early and really shape the development, be leaders in the space, and have growth opportunity. That is the lens by which we look at external opportunities. But because we get in early, it is important to have these bets to be able to place. Then third, it is being opportunistic with our share repurchases. We have bought back over $500 million year to date, and we are going to continue to opportunistically buy back shares, and return capital to shareholders. And then probably last question here. Bernard, as CEO, it has obviously been a great opportunity. What has changed the most in terms of how you allocate your time and your focus today versus in your previous role? What organizational cultural changes do you think are needed to be made in order to operate many different growth platforms and keep this company, which has been so dominant in a single category, expanding into multiple categories. I announced I was going to become CEO about four years ago. It was December 2022, and it has been an amazing journey leading this great company. I say one is the decision about selling a non-core business was very important. This gave us clarity on strategy. This gave us agility in our execution. Also, I pay a lot of attention at the leadership team. What I like about this company, I have a very experienced, dedicated group of leaders, and all of us are deep in structural heart. When you think about when we meet on a regular basis, everybody understands valves. Everybody understands Aortic Stenosis. Everybody understands mitral tricuspid heart failure. It is not the leadership conversation where you have to discuss about the world and be deep, which is impossible. I believe these things together is something that I pay very much attention and building upon. Also the culture of a company where it is very mission-driven. All of this, in my mind, is what has resulted in the performance so far of the team in MedTech. But even more important, all of the catalysts across the five therapy areas. To give us confidence that we are going to maintain this kind of top-tier performance with durability, EPS leverage, despite the company growing almost $7 billion in revenue this year. What we said long term is, the target is to grow the top line about 10%. I would say inspiring goal, inspiring way to bring things together, impacting patient care, and delivering top-tier performance. Okay. With that, we are actually out of time. Thank you so much. Pito, thank you very much, everyone. Thank you.