Matt Miksic: Hey. Thanks so much for taking the questions. So just one question on sort of TAVR and transcatheter valve growth, and I’ll just keep it to one. If you could maybe talk a little bit about the launch of EVOQUE and the activity that, that drives in some of your major centers. And I guess how you’re — you and the team in the field is kind of managing those activity levels or the bandwidth of those centers versus the continuing volumes that they perform in TAVR. Just maybe any color or thoughts on how that might play into the total transcatheter business? And then Scott, I don’t know if you’d be willing to do this, but if you can possibly quantify the impact on SG&A that you’ve mentioned about the field resources and sort of patient activation resources that you’ve planned and are executing on this year? Thanks.
Larry Wood: Yeah. So I’ll start, Matt, and then I’ll hand it over to Daveen. This is kind of like what Daveen and I do every day. We partner very closely on these sorts of things. And clearly, as we roll out these new therapies, we want to make sure that people do it with the right volume. And so it’s a key part of when we start centers, making sure that they have a whole program that encompasses their entire structural heart patient population. And so our teams work closely together. We have this unique environment where we have very dedicated teams because we want to bring that detailed procedural knowledge and the knowledge of all things related to it. But it still requires a lot of coordination between Daveen and I, and we’ve been doing this for a while. This is true with PASCAL and the launch is there, and it remains true of a boat. Daveen?
Daveen Chopra: Yeah. I mean, I’ll just add maybe some comments about the — maybe the capacity question that you kind of asked, right? The rally is in mitral repair, right, in cure technology that’s been around for several years and continues to grow with more and more patients being treated. The number of patients being treated and kind of minds me EVOQUE is relatively small in quarter one and for the future just based on these very large, more established numbers of procedures. So for us, overall, I don’t necessarily believe that the EVOQUE procedures for any time in the near future are going to affect overall capacity. But I do also — and to put — carry on to Larry’s point, we collaborate very well together to ensure that when we’re opening up a center or working with center for the first time, we’re working with that center to ensure that they do have the capacity to then add in these incremental procedures.
Bernard Zovighian: What it is fair to say is that so far, we have not faced a big challenge in terms of center having a lack of capacity to be able to treat the patients, whether TAVR patients or EVOQUE patients.
Daveen Chopra: EVOQUE patients.
Bernard Zovighian: EVOQUE patients, yes.
Scott Ullem: And Matt, it’s Scott, your question about SG&A. You heard us say in the opening remarks that we’re expecting SG&A as a percentage of sales to be around the top end of our original range of 29% to 30%. And that move up a little bit was largely based upon the increased investments that we’re making in field resources and patient access initiatives. And it also kind of gets to Larry Biegelsen’s earlier question about why we didn’t move EPS guidance range up yet. We’ve been waiting to see how sales trended here at the beginning of the year before deciding how aggressively we wanted to go after some of these investment initiatives. And based upon first quarter sales, we’re going to move forward with some of those, and that’s the reason we’re moving up our spending outlook.
Matt Miksic: Thanks so much.
Operator: And our next question comes from Shagun Singh with RBC Capital Markets. Please state your question.
Shagun Singh: Great. Thank you so much and sorry about earlier. It just sounds like U.S. TAVR growth was high-single digits. Is that fair? Was it about 10%? And other drivers that can get you to consistent double-digit growth in the foreseeable future? Just what’s your confidence there? And then I wanted to get your take on AHA’s aortic stenosis initiatives. It seems like they’re expanding that to additional centers. And some of our checks have suggested that, that has a positive impact on TAVR volumes. So just anything you can share on that program, the scope of expansion and potential volume impact to TAVR. Thank you for taking the questions.
Scott Ullem: Yeah. I’ll take the first part of that about U.S. TAVR growth. We try not to be too specific about breaking down every region. But what we can say is that TAVR in the U.S. grew faster than our global underlying growth rate for TAVR in the first quarter. Larry, do you want to talk about the other pieces?
Larry Wood: Sure. So the AHA program, we’re very excited to partner with the AHA on this. And you’re looking for an analog years and years ago, the whole door-to-balloon drive where they created a quality metric that was based on time. And because we know the faster when a patient is having an MI, they get a balloon across that lesion, the survival rate rises dramatically, and it’s critical that they do that. But for AS, we really don’t have any quality initiatives around the time from diagnosis to treatment. And I will say most centers sort of start the clock when the patient ends up with the heart team, and they think they do it pretty quickly. But the part of the story that they miss is the upstream component. From the time that patients got that first echo that they have severe disease, sometimes there’s a long journey before the patient actually gets referred to the heart team.
And we’re trying to do is work on a time metric like door-to-balloon where every patient has to get treated within 90 days of diagnosis. And one of the first things that it does is centers have to go back and look at what their own data say. And most centers think they’re doing a good job and when they actually dig deep and find their own data, they find out they’re not gearing near as well as they thought they were. But if we can get this quality metric implemented, then it would completely change the urgency around patients move through the system. It would be a quality metric they would have to report on. So we continue to expand this initiative but the real goal is to make a guideline or quality metric be part of the system where centers would have to report on it.
And we think we do that, it could dramatically improve patient care because we know these AS patients do not wait well. They have very high mortality rates. If you go all the way back to Part 1, which was the higher risk patients, they had a 50% mortality rated a year when left untreated, and that mortality rate starts very quickly in the process. So we’re very excited to partner with AHA, and they’re a great partner for us because they have demonstrated expertise in getting these sorts of things put in place.
Shagun Singh: Thank you so much.
Operator: Our next question comes from Chris Pasquale with Nephron Research. Please state your question.
Chris Pasquale: Thanks. First on EVOQUE, you’re launching a pretty meaningful price premium to the other technology out there. Do you see the implementation of the NTAP in October is a gating factor for commercialization or do you think you can make significant progress over the next six months prior to that incremental reimbursement kicking in?
Daveen Chopra: Yeah. Thanks for the question, Chris. Appreciate it. Yeah. So first, just a couple of comments. We really believe that EVOQUE offers exceptional clinical and economic benefit to both patients and health care systems. We think that’s a key factor. And we’ve seen a great increasing interest and demand from physicians to help have this technology treat their patients. So the results, I think we’re going to see continued centers opening up and continued kind of patient grow each quarter. If you think about the NTAP, what you mentioned with NTAP, that were psyched that CMS is actually proposing to move forward with NTAP. And then we hope that expects, as you said, to start October 1. And that helps make up any incremental cost between the cost of EVOQUE procedure versus the existing DRG, which is that DRG for TAVR and TEER.
So we think that will continue to add to it. But between now and that we continue to see a lot of interest from physicians as well transcatheter system because we think this technology does so much for patients.
Bernard Zovighian: Probably fair to say that NTAP will have a big impact next year and the year after, but not necessarily this year. Thank you.
Chris Pasquale: Okay. And then it sounded like there was a purposeful mention of the commitment is fielding both replacement and repair technologies for both tricuspid and mitral and tricuspid, the early consensus from physicians seems to be the replacement is going to lead the way. How are you thinking about which patients might be best served by each technology. And what that means for EVOQUE today and then longer term, how PASCAL could deal in tricuspid as Class TR gets closer to completing enrollment.
Daveen Chopra: Yeah. This is Daveen again on a couple of comments on this one. Generally, yes, we are believers that both repair and replacement technology for each valve really helps treat the maximum number of patients. These patients and these disease states are heterogeneous. There’s no one magic bullet. There are a lot of patients that continue to need different types of technologies. I think all of us, the physician community, the medical committee ourselves, we’re all continuing to work and figure out which product repair replacement is right for what patient. Do we have a clean answer today? No, but we continue to work on it and have some ideas, definitely so. With technologies like EVOQUE, we see like this unique elimination of TR, right, big quality of life improvement.
And we see these favorable trends that all-cause mortality and heart failure hospitalizations, along with a very predictable procedure, very clean kind of times. In Europe now, we’re starting to have a little — we already have PASCAL for now a couple of years in Europe PASCAL tricuspid, where people really love PASCAL where it has some really great features for the tricuspid valve, really a atraumatic clasping, etc. But physicians there are starting to see how EVOQUE makes a lot of sense for certain segments of their patients. So no, we haven’t quite figured out the exact mix of these patients, but we know both are really important for treating the most patients.
Bernard Zovighian: That’s great, Daveen. Maybe I will add something about six, seven years ago, we believe that having repair and replacement for both mitral and tricuspid was going to be important. Today, we are confident that indeed it is the case. And this will provide a physician options to treat many patients and to best select what therapy for what patient. So if you’re asking what exactly technology for what patient, I think it is still early. We still — we need probably more times, more research to do that. But for sure, I think this portfolio put basically a physician in a driver seat to make the best decision for their patient, which is what we wanted initially. And as a result, this is going to unlock this very large opportunity and we are going to see a sustainable growth from TMTT in the years to come.
Daveen Chopra: And I’ll leave it up on your comment about kind of the clinical data, right? And that’s why it’s so important that we continue to enroll in trials like Class II TR. So that’s our tricuspid trial, right? It’s a randomized study where getting more data in understanding how these different technologies can really help patients. It’s super important for ourselves. So not only post-market studies for EVOQUE, but also these other randomized studies, pre-market that are so important to collect this data to continue to understand where these technologies can work best for patients.
Chris Pasquale: Great. Thanks.
Operator: Our next question comes from Pito Chickering with Deutsche Bank. Please state your question.
Philip Chickering: A follow-up to Chris’ question. I just want to make sure that I heard that you expect limited EVOQUE sales until the NTAP kicks in October 1. And with G&A, at the high end of your previous guidance to 3%, how many centers do you think will be ready to perform the procedure by that date?
Daveen Chopra: So this is Daveen. On the NTAP comment, we believe right now, each quarter, we continue to open up new centers. We continue to train physicians on it, and it’s a steady state, nice growth in providing the technology to more patients. And we’ve seen a lot of demand from physicians for this technology for these patients. I think to Bernard’s point, NTAP adds a continued allowance of growth as it gets to more scale, that will really help support 2025 and 2026 growth. And then the second question was — I missed the second part of your question.
Scott Ullem: I mean, I think the question was how many centers do you think we’ll be ready to do procedures once the NTAP is active. And I think what we can say is, certainly, the sites that have been involved in clinical trialing are going to be ready to activate beyond that. We’re just going to be strategic and deliberate about where we activate.
Daveen Chopra: And we’re going to focus on centers that are already the higher volume tricuspid centers that have their infrastructure set up, have their right side imaging set up. So it’s going to be just a steady kind of both of [indiscernible] centers and moving to other high-volume tricuspid centers.
Philip Chickering: Okay. And on the asymptomatic in the indication, if that trial is positive to get FDA approval, is that going to be exclusive to SAPIEN? And any color on how much creep you’ve seen, if any, for docs treating asymptomatic patients today?
Larry Wood: Yeah. Thanks. Well, none of us know the trial results as yet, that won’t happen until later this year. So if the trial is positive. And obviously, the more positive trial is, the more benefit that you get from it. But I think it’s really about how patients get referred for therapy. And I think that, that’s going to be the key thing. So I think it speaks to the treatment in referral for aortic stenosis and the timeframe we should do that more than a specific therapy. Now that being said, it is a randomized trial against the SAPIEN platform. And so if you’re going to think about treating patients earlier, you’re going to have a platform delivers outstanding clinical outcomes, right? You’re going to have to have those low mortality rates.
And this is where we think our platform really shines because if you look at, again, our PARTNER III low risk data, we had 99% survival at a year. We had 90% survival rate at five years and very low complication rates. And that’s probably more in line with the patient population that would be asymptomatic, is really more towards a lower-risk patient population. And we’re the only one to make the investments in that trial at this point. So — but I do think it speaks to the deadliness of the disease broadly.
