Travis Steed: A quick clarification and was on FX. I think the revenue guidance stayed the same, but FX was $100 million better. Just wanted to make sure I understood the moving parts on that? And then the question was also on U.S. TAVR. It’s hard to tell exactly, but it looks like U.S. TAVR was down versus Q3. So I don’t know if there’s anything to call specific headwinds in Q4 that maybe weren’t in Q3 and if it was actually down in Q3 versus Q4? And then how to think about Q1 in the U.S., can that still be up sequentially and grow kind of year-over-year in that 9% to 12% range?
Scott Ullem: Sure. So on the first question about FX, yes, you’re right. We originally anticipated about $100 million headwind to sales based upon recent currency moves, we now think it’s about flat. We do think there will be a headwind to sales in the first half. There will be a tailwind to the sales in second half of 2023, but it averages out to flat for the full year.
Michael Mussallem: If the rates stays though.
Scott Ullem: At the current rate. Regarding TAVR, no, there was actual growth in TAVR in the U.S. over Q3, and we’re expecting more growth in Q1 over Q4. So we’re seeing sequential growth and year-over-year growth expansion in U.S. TAVR and global TAVR.
Travis Steed: Okay. Great. I’ll recheck the model on that. And then on SAPIEN 3 RESILIA. You mentioned a little bit of color on the launch. Curious how it’s gone like price uplift versus volume discounts, you’re actually getting all the price? Because I think the guidance is assuming stable pricing. So I just want to make sure I’m clear on how to think about pricing impact this year and maybe the pricing comes more in 2024?
Michael Mussallem: Yes. So we are going for a price increase and we’re going for a price increase across the board. What ends up happening with pricing is as volume goes up, we have rebates and those were built in, whether it was SAPIEN 3 pricing or whether it’s SAPIEN 3 UR pricing but we are going for a net increase on every SAPIEN 3 UR valve that we have. Again, it’s about $1,500 less than 5%, but we are going for that across the board.
Operator: Our next question comes from Josh Jennings with Cowen.
Joshua Jennings: I want to just start with a question on the surgical valve business. It grew at a higher clip than the TAVR franchise in the fourth quarter. And just wanted to maybe get some — a better understanding on this prioritization of heart surgeries that you called out. Do you expect that to continue and maybe be beneficial to understand price versus volume growth for the surgical valve business in 4Q? And then I just have 1 follow-up.
Larry Wood: Sure. Well, I’ll start and then if I have rent trouble on call my buddy to mean to help me out here. But overall, the thing with surgical patients is they don’t require the same amount of work up as a TAVR patients. So they can move through the system faster because they don’t require things such as the CT for valve sizing where that’s been intraprocedural for the surgeon and so there’s just much workup that has to be done for those patients. So maybe it’s a little less impacted. I think there’s also a mindset that when a patient needs open heart surgery, that, that just is more urgency in the system and those patients can move through a little bit quicker. We’ll see how that continues over time. But we continue to drive RESILIA on the surgical side as well. We have the MITRIS launch, which is going, and we continue to advance RESILIA on the aortic side as well with INSPIRIS and those continue. I don’t know if you have anything to add, Daveen.
Daveen Chopra: Yes. The only other comment I’ll make is we talk about heart valve surgery being prioritized within hospitals. We see a bit that, as Larry said, in the food chain of kind of surgeries, we see that people generally if they’re short in cardiac surgery resources help start moving resources to these really high acuity really important patients from other parts, other surgery departments. So you actually see a little bit of resource moving, which I think has helped cardiac surgery keep its volumes overall. That being said, the macro picture, right, we always expect that TAVR is going to increase in aortic valve replacement. But we also expect, at the same time, the AVR market is going to continue to grow, and there’ll always be these patients with complex disease that need surgery.
Joshua Jennings: And just a follow-up on the early TAVR results are not in the very near term, but thinking about the asymptomatic severe aortic stenosis bucket and just the percentage of total severe aortic stenosis patients in the United States. You guys have any new kind of estimates in terms of is that a 30% of total, 40% of total or lower? I just wanted to better understand what early TAVR could unlock?
Larry Wood: Yes, it’s a difficult question because the literature is all over the place on this topic, and there’s not great studies on this in terms of how it gets looked at. There’s a lot of studies out there that say for every asymptomatic — or for every symptomatic patient, there’s an asymptomatic patient, so that’s probably on probably the higher end. There’s other studies that says that it’s a little bit lower. But I think regardless, it’s significant, but I think the bigger issue here is it impacts how patients flow through the system because patients come and the doctor says, how are you feeling? And maybe that day the patient feels fine, but two weeks ago, they were struggling and that doesn’t necessarily get picked up.
I think if we could take the symptom assertation just out of the equation for patients and if your echo says that you have severe AS, you move directly to therapy. I think it would just be a game changer for how patients flow through the system. And it’s one of the reasons we took on EARLY TAVR is we think we need to have the definitive data that shows what happens when you really stress echo these people, what happens when you really follow patients that are asymptomatic, and that’s really the purpose of the trial, but we think it’s a significant opportunity to change how aortic stenosis is treated.
Operator: Our next question comes from Adam Maeder with Piper Sandler.
Adam Maeder: The first question is on ACC, which is coming up in a couple of weeks. I’m wondering if there’s anything that you’d call out from an Edwards standpoint in terms of notable clinical data. And then there’s a competitor study in the tricuspid space with TRILUMINATE. Do you think that study could potentially catalyze the transcatheter tricuspid market, both repair and replacement? And then I had one follow-up.
Daveen Chopra: Yes, this is Daveen. I’ll hit a little bit on the — obviously, the tricuspid trial, specifically the TRILUMINATE study. We actually wouldn’t be surprised if TRILUMINATE shows positive results and gets approved by ACC or around ACC. To me, this would be an amazing opportunity and great opportunity for patients to continue to get more data and have better patient treatment. But that being said, we see actually in Europe right now that clinicians are actually very positive about the performance of our differentiated PASCAL Precision device there and seem to really like it for tricuspid patients. So we look forward to that to obviously bring that technology to the U.S. in the future. But we think for the therapy overall, obviously, more data is helping patient care.
Michael Mussallem: And then a high level, we’ll be at ACC in full force. It’s a chance for us to be close to customers. But we don’t have any real groundbreaking trials that are going to be introduced at that time.
Adam Maeder: Okay. And then just for a quick follow-up. One actually on capital. allocation. And clearly, you’re going to remain focused within structural heart. But I also think you’ve talked recently about having interest in a potential new adjacency. And I think referring to heart failure, you have an internal atrial shunt program, and you also have some investments in external assets. So when should we expect to learn more here about these initiatives and just the broader path forward?
Michael Mussallem: Yes. Thanks for that, Adam. We don’t end up talking about these until some of the risk has been taken out. At these early stages, these are big transformative therapies that have big potential, but they also have pretty big risk at the early stage of the program. And we feel like it’s more appropriate to share it with investors when we have more uncertainty. So for example, like we’re already in human trials. So we’re not likely to talk about this for competitive reasons, but it is something that’s very much a priority for our company. We think the kind of skill sets that Edwards has could be applied really, really well to this big group of patients that’s the #1 health care burden and cost and mortality both. Operator Our next question comes from Richard Newitter with Truist Securities.
Richard Newitter: And thank you for the color on the quarter-over-quarter growth, U.S. TAVR expectation in 1Q. But I’m hoping to just parse out the expectation around cadence for improvement U.S. versus international in three seems like international, a little bit more kind of COVID surge impacted maybe a little more visibility into the turning of the tide there. U.S. more hospital staffing it feels more gradual. A, is that correct? And do you think it’s right for us to be modeling a little bit faster recovery and acceleration perhaps in 1Q and the first part of the year internationally and then maybe a little bit more of an acceleration for the U.S. in the back half and keep it more gradual in the first half? Is that a good way to think about it? And do we have the pieces right around your visibility?
Scott Ullem: So Rick, first, on the sequential growth. I want to go back to something Travis asked about before. Q3 to Q4 and 2022, there are sequential growth globally. I said U.S., it was true globally. Q4 through Q1 and 2023, sequential growth in the U.S. and globally. As it relates to the full year 2023 I’ll start and then others chime in. We’re expecting contributions both in the U.S. and outside of the U.S. It’s tough to pin down exactly which regions are going to grow what rates. But we think that we’re going to get contributions from all of our major regions to that 9% to 12% underlying growth in ’23.
