Edwards Lifesciences Corporation (EW) Earnings Call Transcript & Summary
January 10, 2022
Earnings Call Speaker Segments
Robert Marcus
analystWelcome back, everyone. I'm Robbie Marcus, the medtech analyst at JPMorgan. Very happy to introduce our next company, Edwards Lifesciences. We're going to have CEO, Mike Mussallem, do the presentation and joining us for Q&A afterwards is CFO, Scott Ullem. Just a little housekeeping, feel free to e-mail me any questions or submit through the conference website, and I'll do my best to ask them. With that, Mike, I'll turn it over to you and join you in a little bit.
Michael Mussallem
executiveAll right. Well, thanks a lot, Robbie, and hello, everybody. I can't believe this is the 40th Annual JPMorgan Healthcare Conference. I think I've been at a great number of these. So today, we'll be making some forward-looking statements that involves risks. You can find a list of those on our website and on file with the SEC. And we'll also be using some non-GAAP financial measures, which are helpful, and we have reconciliations from GAAP to non-GAAP, also on the edwards.com website. So I always like to start out with our credo. Our credo is prominently displayed in all of our facilities around the world. We talk about it all the time. We ask our employees to please live it and they do. A couple of noteworthy elements. We talk about being a trusted partner to everybody that we're involved with and that it's a multi-stakeholder model, and we were born that way. So we said, when we get it right, we help customers, patients, employees and shareholders. And we close with helping patients is our life's work, and life is now. And that's a powerful attractor of the best talent. People want to really have a career that's committed to helping people if they're going to put all this time and energy to it, and it's a powerful motivator for all of us. Just a snapshot of Edwards Lifesciences. We're a very global company. We've got manufacturing sites around the globe. I've been so proud of our supply chain that they have delivered during this very challenging time. As a matter of fact, our service levels are higher in 2021 than they have been in the past 3 years. We're fortunate to be in strong global positions, almost everything that we sell are in #1 global positions. And we've got a great base of employees. We've got a lot of very smart people that work in our organization and powerful R&D. And out of our group of 15,000 employees, we have many with deep experience at Edwards that have really developed expertise over the years. But we also have more than half of our organization that are new in their career and bring fresh thinking and it gives me a lot of optimism for the future. Our strategy, which we call the patient-focused innovation strategy is relatively unique in medtech. First, we talk about innovation. And then, we're talking about big pioneering breakthrough innovations, not small innovations. That's what we strive to do. Now of course, that involves risks. That's very difficult to get right. And we know that even when we get it right, we need to back it up with compelling evidence. So this tends to create long time frames in terms of us getting really value from the innovations. We also are believers in going first and being the leader. That also involves risk because you can always learn much from those that stumble and fall before you. But when you go first, you learn faster, and it also puts you in the room with policymakers when you're trying to craft what that new groundbreaking treatment might look like. And so we really value that leadership position. And finally, the way that we manage those risks, the risks that are associated with innovation and leadership is by staying singularly focused on the unmet needs of structural heart and critically ill patients. By staying focused on this group, it allows us to just know more about the patient journey and the treatment options. It puts us in a great position because even though it sounds narrow, just structural heart and critically ill, there are a lot of patients that need our help. And we know the big picture, when we create meaningful value by transforming care, that value pervades everything that we do. Now this strategy has paid off. We've had more than a decade of double-digit growth. And part of it is because this patient demand is so significant. What we always strive to do is what we call the triple win. What if we could have an innovation that extends life, improves the quality of life and is cost-effective for the health care system? When we get that right, we really ring the bell. It is long term in nature, and it means that we're actually living right now off those seeds that were planted years ago. And the seeds that we're planting now are the ones that are going to pay off in the future. But it's been a successful formula, and we are very focused and going to continue with our strategy. Now let me just give you a quick overview of our Edwards positions. We're fortunate to be in leading positions in each one of our businesses. The global Transcatheter Aortic Valve Replacement business is the biggest in the Edwards portfolio. That's today around $5 billion. We expect that to about double by 2028. What's going to drive that? Greater awareness in this really breakthrough therapy, continued advancements in technology and then indication expansion and geographic expansion, it's still not widely adopted around the world. And so increasing the diagnosis and treatment rates of AS is key for us. And part of making that happen is groundbreaking trials. Interestingly enough, today in TAVR, we're -- as a matter of fact, it's also true in surgery, we're only treating the disease when it gets severe. And not only that, it has to be severe and the indication says that it drives symptoms in the patients. It makes it a complicated indication. And it means that many patients aren't getting this progressive disease treated earlier. We've got 2 big groundbreaking trials, which we hope to expose this as flawed thinking. The thinking probably made sense back in an age 60 years ago when it was created, when surgery was the only option. But now that we have TAVR, we're doing the early TAVR trial, which randomized patients that supposedly have no symptoms. So one group gets watched and the other group gets TAVR, and we see how they look at the end of 2 years. We've completely enrolled that trial as of the end of this last year, and we're looking forward to this putting a spotlight on the importance of earlier treatment. Also aligned with that is the new progress trial, which we just kicked off at the end of last year, which is to really evaluate patients with moderate disease. And so I think rather than waiting to the disease is serious, what if you treated it while it was still moderate. And it's again randomized TAVR versus watchful waiting, which is what happens today. We believe that, that's going to be very enlightening in this idea of, oh, you should wait until the disease gets worse is a flawed notion. And we expect these trials to put a spotlight on that. Our portfolio has been an impressive one in the past. We're very proud of the SAPIEN 3 Ultra system. It's delivered a pretty spectacular procedure. These procedures routinely happened in about 45 minutes. We got next-day discharges at 80% of the patients. The paravalvular leak rate is quite low, less than 1% at 30 days. So a lot to feel good about. And we've been able to take that and parlay it into treatment of the pulmonic valve. And just recently, we just got an approval, which we're very excited about of Alterra, which is a preset system, which allows you to use the SAPIEN valve in the pulmonic position. Think of it in the right flow -- outflow tract that helps these patients that were born with congenital disease as a smaller group or a group in great need. And then what's going to come next? And as good as TAVR is today, we think it can be much better. We're excited about just launching the trial on SAPIEN X4. This trial is going to really take a hard look at the SAPIEN X4 valve, and we're excited about what that's going to mean for patients. And we're also committed to even longer-term research. And we always have next-generation systems that are going on -- that work is going on inside Edwards even as we speak in revolutionary new platforms. And so we think the advancement of this technology is another important element of developing the therapy. Now we're getting into a whole new area, which is the transcatheter treatment of mitral and tricuspid disease. We think the time is right to have catheter-based treatments for these complex valves. The way we've approached it is to come forward with a differentiated group of therapies to back it up with clinical trials and to really focus on getting great real-world clinical outcomes. And so this is a large group, it's undertreated, and it has a variety of etiologies. We think this could be quite large, that this could be a $5 billion opportunity, easy, by 2028 and growing significantly after that. It's a large group of patients. This more than 4 million is just in the U.S. And today, there's a very small group of those patients that actually get treated. And that's because we believe that the treatment options haven't demonstrated strong enough results to really back up treating them. And that is the opportunity. If we can develop great procedures for tricuspid patients and mitral patients, and that's why we developed this toolbox, we think that we can increase those treatment rates dramatically. We're involved in 5 big pivotal studies to back this up. These are highly scientific, rigorous, really designed to change guidelines and to drive adoption. And we've never had this much research going on in a field in the history of Edwards Lifesciences. And we're really looking forward to providing this strong evidence on the importance of this treatment. In Surgical Structural Heart, we actually believe that surgery is going to continue to grow and being a very important part of therapy as we move ahead. There are some patients that are just -- they're not going to be good candidates for catheter-based treatments, and we continue to partner with surgeons to address some of the unsolved challenges involved in surgery. We're pioneering some efforts, and we think this is going to continue to grow in the mid-single digits between now and 2028 and even more. One of the reasons is, it's dramatically undertreated in many geographies around the world. And as these countries actually gain wealth, they start with surgery programs first and foremost. One of the things that we're most proud of is the tissue technology within Edwards Lifesciences. We have a long history and heart valves goes very back -- go back to the very first heart valve in a mechanical valve that happened over 60 years ago. And our latest advancement, which we call RESILIA, which is a tissue treatment that we've been working on for more than a decade, we think, really demonstrates best-in-class performance and durability. It's really encouraged patients to engage at a higher level than we've ever seen them before because patients reason that if I'm going to go through a surgery, I want a very durable valve. And RESILIA has that tremendous kind of promise that patients have the opportunity to maybe live longer with a higher quality of life and not have the risk of that next surgery. We have a number of products now that have RESILIA tissue, the flagship of which is the INSPIRIS valve. The INSPIRIS valve not only uses RESILIA tissue, but it has a feature called VFit, which makes it ideal for a future valve and valve procedure using TAVR. The INSPIRIS valve has become the #1 heart valve in the world in this short period of time, and we're very pleased with the amount of data that's now available that backs this up as a durable option and look forward to collecting more in the future. We introduced a product last year that's been very popular with surgeons. Often, there will be a patient that presents not only with valve disease but also some of the disease that goes into the aorta above the valve. And with the Connect system, we actually have created a valve conduit that they can use to very -- not very easily, but more easily treat these patients. And it's been quite popular and again, has the feature of having RESILIA tissue. And then just last year, we introduced the MITRIS valve for the first time. It also features RESILIA. It has an easier to implant geography. It's been introduced first in Japan, and we expect it to be approved in the U.S. in 2022, and we're very anxious to bring this tissue technology to the mitral position. In the past, there's many of these valves that have been mechanical valves, which means that the patient lives with a lifetime of anticoagulation and the promise of this mitral valve is impressive. In Critical Care, we've always had a reputation of being excellent and really the best in monitoring the hemodynamics of patients that are going through a big surgery or in an ICU. The future of this is really shifting the product mix towards smart recovery. And I'll tell you what that means. There are sort of some key building blocks around that, that means that we're going to be able to help clinicians make better decisions so they can help their patients recover faster by the use of technology. We think this is also a big opportunity, which is going to allow for growth into the future. The building blocks are this. One is a modern monitoring platform. This is HemoSphere today, and we'll be moving into new systems beyond that. These are intuitive systems that use the latest technology and can connect seamlessly with the hospital systems. We also are noted for great sensors that are able to very accurately gather information and do it less invasively than ever in the past. And finally, and what I'm most proud of, is our new algorithms, which allow us to be smart and analyze data and be predictive in terms of what kind of bad event might happen in the future, which allows the clinician, let's say, in this case, an anesthesiologist, to adjust care before the problem occurs. We're at the early stage of this, the evidence that's been created is powerful, and we're about to create even more evidence. And we think that the adoption of this is going to be an important driver for Critical Care into the future. Now to just give you a sense for the growth outlook and to talk a little bit more about numbers. 2021 was a year of driving value. We feel like we entered -- that we exited the year even stronger in each one of our businesses than when we entered the year. We continue to stay focused on innovations, achieving milestones. We spent 17% to 18% of our sales in R&D and made really important progress on milestones. At the same time, trying to deliver some impressive sales results. Again, I'm very proud of our global supply chain and of the investments we made in '21 that will pay off into the future. We estimate that our sales growth will be in the high teens and the EPS growth will be slightly faster. Now you'll recall at the Investor Conference on December 8th, we said we're expecting a gradual COVID recovery and no significant impact from new variants. Since that time, Omicron has obviously spiked, it impacted the health care system and procedures negatively. But considering the range of our sales guidance, we are not updating our sales guidance. So with that -- well, this is the same slide that I shared at the Investor Conference about a month ago, is that 2022, we expect to be a year of significant milestone achievements and a lot of investments in our future. We're going to be advancing these big TAVR trials. We expect to have a DMR, so a degenerative micro regurgitation approval for PASCAL. By the end of '22, we expect to have our EVOQUE valve for the tricuspid position approved by the end of '22. We expect to have a MITRIS approval for surgical in the U.S. and continued adoption of RESILIA, and we'll be advancing our Critical Care technologies as well. So we expect our sales growth to be in the low double digits and earnings growth to be a little faster than that. So what's more important when you think about Edwards Lifesciences is the long-term future. We think that the market that we serve today is going to nearly double between now and 2028, with impressive growth in TAVR and TMTT, but it will cross our whole portfolio. The TMTT, in particular, we think, is going to enjoy a significant growth rate because of the new innovations that are being introduced within that area. So I'll just sum it up by saying I have a lot of confidence in our future. It's based on the centerpiece of our patient-focused culture. We did a -- we do surveys with our employees. One of the questions that we asked is, at Edwards Lifesciences, we think about patients when making decisions and over 90% of our employees around the world said yes. And this gives me great confidence that we're on a bedrock of strong culture. There are large populations that are undertreated and really need the treatments that Edwards are developing. That gives me confidence. We have tried to operate in a way that we've developed credibility and trust with our patient communities, with physicians, with regulators, that gives us the privilege of further innovating in the future. We have a heck of an R&D team while with a tremendous amount of talent and a tremendous amount of drive that we think have the opportunity to really create these big life-changing therapies for the future. And when we get that right, we think it leads to sustainable organic long-term growth. So I really feel good about where we are and feel like we are just getting started. So with that, that wraps up my formal presentation. And Robbie, I'll turn it back to you.
Robert Marcus
analystYes, great. So maybe we could start with your comments on 2019. And I want to just parse out, how much of this is repetition from the Analyst Day? Or how much of this is the final result and -- with -- you had guided...
Michael Mussallem
executiveOne second, Robbie. Why don't I introduce Scott Ullem? Scott is our CFO, is going to join us. I just want everybody to know that we've both been vaccinated and boosted and we tested ourselves, so we're in a safe environment, but we thought it would be better to have Q&A where we're both in the studio. So again, would you mind repeating?
Robert Marcus
analystYes, sorry. I just want to make sure, you made comments about high teens growth for the year. That was right in the middle of your guidance range on an organic basis for the company. Just want to parse out, is that an update as where you ended up for the year? Or just repeating the comments from the analyst event?
Michael Mussallem
executiveYes. Really, it's just repeating the comments from the analysts event. We are not updating our guidance. So what we're saying, hey, we live in the real world. Everybody knows what's going on with Omicron. And clearly, that's impacted the health care system and it's impacted procedures negatively versus what we thought when -- earlier when we made the forecast. But having said that, considering the range of our sales guidance, we're not updating guidance.
Robert Marcus
analystGreat. And as we think about 2022, you made the comments as well, you contemplated a range and so you're safe within that range as you sit today. Anything changed versus your prior thinking about the cadence throughout the year? Is perhaps maybe the back half a little better or...
Michael Mussallem
executiveYou're on a key point, Robbie. I mean, I think we'd all acknowledge that clearly, January is starting slower than we originally planned. There's no doubt about it. But we don't think that there's enough evidence for us to change anything about where we are for our guidance for 2022. You'll recall back in '21, we had a similar tough start to the year because of what was going on at the time and then a very strong Q2, which seemed to do some compensating. So we don't have great visibility into exactly how this might roll out across 2022. But at this point, we're not changing any guidance for 2022.
Scott Ullem
executiveYes. And of course, we'll give details on this, Robbie, in a few weeks when we do our fourth quarter earnings call, and we'll talk about what our expectations are for Q1 and for the rest of 2022.
Robert Marcus
analystMaybe last question here on COVID-related trends. As I think about -- 2 years ago when this first hit, TAVR was pushed out completely, and it negatively impacted a lot of patients. Where in the treatment paradigm of hospitals, fast forward to today, is it falling? Are they getting priority for beds in surgery? And does it vary from location to location?
Michael Mussallem
executiveYes. I think you said it right, Robbie. There's a great deal of variability. There's a great deal of variability around the world. And so it feels like it's hit quite hard in the U.S. It started hitting hard in Europe, less impacted Asia. So highly variable around the world. And even within the United States, there are regions in the United States, whether it's the Midwest or Northeast that are feeling it far more acutely than other regions. So again, highly variable. What we end up seeing is something that's very different by hospitals. A small hospital might say, you know what, we're overwhelmed right now. We're almost going to do no procedures in January, whereas a more significant one might bump it up to the Chief Medical Officer, where they actually triage and decide which ones they're going to do and which ones they're going to postpone. So it's just highly variable right now.
Robert Marcus
analystShifting gears a little bit. I want to start with the TMTT pipeline. This is clearly the most exciting future growth driver here. I don't know if you disagree. But the one thing that really hit home for me was the tricuspid, the TRISCEND data. This is tricuspid replacement. We saw the data at TCT. This is really, in my view, one of the first closer to real-world trials and less of a cherry-picked patient population. And it had fantastic results for a very difficult to treat disease. So maybe talk about your view on tricuspid, you're way ahead in replacement there, replacement versus repair? And then we could go touch on mitral afterwards.
Michael Mussallem
executiveYes. We are very excited about the TMTT portfolio, and we think it does have an incredible opportunity for growth. And one of the elements of that is treating the tricuspid valve. Remember, this valve was always considered the forgotten valve. People didn't really think about treating this. It was almost a byproduct of heart failure. And there were really no great options. Maybe somebody would treat the tricuspid valve while they were already doing surgery for the mitral, et cetera. And that was it, full stop. But now that we've developed some technologies, and we've got ways of repairing the tricuspid valve using an edge-to-edge technique and also an annular reduction technique. And we also have a full replacement. The one that you were referring to is the data related to the EVOQUE valve in the tricuspid position, and it is very exciting. Again, it's -- we don't have lots of patients at this point and the amount of data, I think we're at 6 months with a cohort of patients. So it's too early to declare victory, but it is very encouraging what we're seeing. And what we hear from physicians is they just don't have options for these patients. They're really suffering. They have a horrible quality of life and that they seem to get relief from this therapy. Now backing that up with really hard-core clinical data is going to be key, but we're excited about this and very focused on it.
Robert Marcus
analystSo this is obviously in the lead in tricuspid. We're going to get approval in Europe, hopefully, later this year with the launch more meaningfully next year. U.S. pivotal is ongoing. What about in mitral? When should we think about the EVOQUE Eos in mitral starting to move more meaningfully into the clinic?
Michael Mussallem
executiveYes. So the -- we're also excited about the EVOQUE Eos, and it is in the clinic right now. It's in an early feasibility study. And at the same time, we have the M3 system, which is actually using a docking system and SAPIEN 3 in the mitral position. That's actually in a pivotal trial that's going on right now. So if there is -- Edwards actually has 2 shots on goal for mitral replacement. And we're excited about both. And actually, we would like to gain a little bit more experience before we decide exactly how to play that. But boy, if we had a really great mitral replacement system, and we have consistent said it's not about getting there fast with a large system, but more important to be transfemoral and be able to really introduce this with a reasonable sized catheter. So think about something sub-30 French. But that's going to be the key because you don't want to subject these patients to these very large systems. And both of our systems meet that criteria. So we're excited about what that can mean. You're going to see a lot more visibility during 2022, just you'll hear anecdotal reports at various meetings. But that's kind of the picture, if you will.
Robert Marcus
analystSo, Mike, one of the biggest or the most common questions I get, whether it's tricuspid or mitral, is on the role repair versus replacement has. Which patients are right for repair, which are right for replacement? Is there a step order? Is it once you get one done, you can't get the other done? And so I would say, how do you think about that? And is it different for mitral and tricuspid?
Michael Mussallem
executiveYes. So let me talk about that a little bit. And I might disappoint you, but there aren't clear answers yet, but with all the data that's being generated...
Robert Marcus
analystWhich is why I'm asking you the tough questions.
Michael Mussallem
executiveBut we're going to have answers before too long. Well, over the next couple of years, there's going to be incredible amount of data that's going to help clinicians make that decision. If you think about it from a surgical perspective, there's always been a notion that if you could repair the mitral valve rather than replace it that you get a better outcome. But repairing a mitral valve is very complex. And in the hands of experts, they get great results. But if you're not necessarily an expert, the results aren't so good. And so the advantages of replacement is it became something that was easier to be more broadly introduced. The same may turn out to be true with catheter-based systems. And we're generating data now on what is that edge-to-edge repair look like? What does that annular reduction repair look like? And what does the replacement look like? I would say, in general, what you would have found in the past is that repair was safer, but that replacement was more efficacious. So the bid ask is, can you create truly safe replacement systems, or can you make your repair systems highly efficacious, meaning no leak when they're done. And so that's what it will play out over time.
Robert Marcus
analystDo you think there might be a role for one technology, especially mitral, in functional versus degenerative where one is really a valvular disease, the other is more heart failure disease? We saw so many of the patients in the early experience pass away when the valve was fixed but the heart was too weak. So do you think there could be this dual role depending on the different patient etymology?
Michael Mussallem
executiveYes. I should have mentioned that, thanks for bringing that up, Robbie. Absolutely. We believe there is going to be a difference. There is a clear difference between degenerative patients and functional patients. And that's why we believe that there needs to be a toolbox. We see such different etiology across this range of patients that it's unlikely that a single solution is going to be right for all patients, which is why we've kind of approached this with the toolbox. Not only will the toolbox obviously get us questions on what system excels with a certain group of patients, but it also puts us on a pretty steep learning curve to really understand what's best for these patients. And so we feel good about this broad approach. We don't have clear answers of who's going to respond best. But there's so much data going on. As I mentioned, we've got 5 big pivotal trials going on right now just in the TMTT space, which should provide quite a spotlight on this exact question.
Robert Marcus
analystSo we touched on replacement. You do have both PASCAL and PASCAL TR for mitral and tricuspid repair. And I was impressed with the guidance you provided at the analyst event for $140 million to $170 million. I think The Street was more approaching $150 million. Walk us through where you see optimism around this? Is it on new centers? Is it more adoption within new centers? Are there a lot of geographies this can move into outside the U.S. this year? Just maybe some of the nuts and bolts of it.
Michael Mussallem
executiveYes. Thanks, Robbie. So as you note, that sales guidance is probably quite driven but almost exclusively out of sales in Europe for 2022. We don't expect to get the approval to move to the U.S. for the first time until the end of '22, and that will really impact '23 results. But the reason that we have some confidence to have that aggressive sales forecast is because of the trajectory that we've been on. I'll just remind you, we've really focused on making sure we do great procedures and get great results every time. When we started 2021, we were almost exclusively in Germany. By the time we exited 2021, we had now brought this through about 10 countries across Europe. So we are on a path to be able to make that happen. And so it's primarily going to become from this expansion to more centers and more countries, which will help drive that number. Rob, you're frozen. I don't know if we lost you.
Robert Marcus
analystHere I am. Sorry about that.
Michael Mussallem
executiveSure.
Robert Marcus
analystI want to get Scott in here a little. I don't want him standing up there for nothing. And maybe you guys can both address this, but you have a lot of cash on the balance sheet, you generate a lot of cash. I think investors would love to see M&A going forward. How do you think about the environment for M&A and not just within your existing wheelhouse, but also are there other areas that might make sense to move into and in your adjacency that could benefit Edwards?
Scott Ullem
executiveSo you've asked a couple of questions. One, all the cash on our balance sheet; two, M&A. And we sort of think about those differently. We're not going to change our strategy because we have cash right now on the balance sheet. And our focus on M&A is really limited to and encompasses structural heart. And the reason that's the case is because we think there's such a huge opportunity to treat patients who suffer from multiple different structural heart diseases that staying focused, deploying our resources internally and supplementing that with external investments is really going to be a path to growth for a long, long time to come. Now the problem of cash on the balance sheet is a good problem to have. And we're going to continue to prioritize use of that cash based on funding internal investments, funding expansion of our production facilities around the world and improving our global footprint. We are going to continue to make investments externally and buying options to buy companies, acquiring companies generally early stage and then using cash on the balance sheet to buy back stock to reduce dilution and ultimately buy down the share count as well. Mike, anything...
Michael Mussallem
executiveI'll just add that we're very proud of our internal R&D capabilities and that's turned out to be quite productive. But at the same time, we keep our eyes open around the world to find those exciting new ideas. And when we find them, we love to be able to create some kind of a deal or a partnership so that those can be part of the Edwards portfolio and we can learn fast related to that. In terms of would we ever go beyond structural heart? No, we're really focused on that. But structural heart is a pretty broad definition if you allow yourself to think about it. So we feel pretty comfortable that we have plenty of places to look for growth.
Robert Marcus
analystMaybe staying on financials. 2022, based on the guidance you gave at the analyst event, looks like it's going to be another heavy investment year into both SG&A and R&D, and you put out some longer-term guidance targets. And I think the R&D component is self-explanatory. We see exactly where it's going. But where is the SG&A going? Where are the areas of investment that still need to be supported and built out? And I would imagine a lot of the new product launches have a high degree of synergy with the existing infrastructure.
Scott Ullem
executiveSure. To a certain extent, yes, there is synergy. I'd say, probably I would characterize it more as a normalized appropriate year in terms of SG&A and R&D investment, not necessarily something heavy because this business is growing quickly enough that we need to fund SG&A and R&D. So let's just talk about SG&A. We've got a budding business in Europe with TMTT. And Mike mentioned before, we're now expanding just PASCAL to over 10 countries in Europe. That requires a pretty significant footprint of full-time employees who are supporting cases, providing training to hospital personnel and really helping to grow this business from what it is today to something much, much bigger. Similarly, in the U.S., we do not have any TMTT infrastructure. We've got a TAVR field force, but we've intentionally made a decision that we're going to have a dedicated, focused, concentrated team of Edwards employees first supporting the launch of PASCAL in 2023. And then beyond that, supporting the introduction of other TMTT therapies as they come along. So that's a lot of where the incremental growth in SG&A is being directed.
Michael Mussallem
executiveYes, I'll just add to that and just pile on. I think Scott said the thing that was most important there, remember the way that we've approached TMTT. We could do this purely leveraging our surgical and our TAVR platform. We decided this is such a big opportunity. And the TAVR opportunity continues to be large as does the surgical that we're better off having specialists in each of these fields. It's really different therapy. We think ultimately, as it gets large, it will be different treaters. And so this idea of having a dedicated team is part of what's driving that. We think there's a great return on that because we believe that the sales will come, but that's a bit of what underpins it.
Robert Marcus
analystThe good news is, I imagine, while your infrastructure may be different, the physician base and the relationships are all the same. Same doctors doing 1 procedure as well as TMTT.
Michael Mussallem
executiveWell, we think that this is going to change over time. So I think it's very accurate to say the physicians that are doing TAVR today, many are also becoming pioneers within mitral and tricuspid. But as that grows, and we expect it to grow substantially, we expect there to be a group of specialists. We already see it occurring in places like Germany and places where it's more mature, where specialists just focus on mitral and tricuspid disease. We expect that to emerge over time as this gets to be a larger and larger opportunity.
Robert Marcus
analystGreat. Well, unfortunately, we're out of time. There's a lot more we could touch on, but we're going to have to leave it there. Mike, Scott, thanks so much for the time and hope you have a great rest of the day.
Michael Mussallem
executiveYes. Thanks, Robbie. Take good care.
Robert Marcus
analystBye.
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