Q4 2024 Earnings Call Transcript

[Starts Abruptly] included in the press release and accompanying financial schedules and then use the remaining time for Q&A. Please note that management will be making forward-looking statements that are based on estimates, assumptions and projections. These statements speak only as of the date on which they were made, and Edwards does not undertake any obligation to update them after today. Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially.

Information concerning factors that could cause these differences can be found in today's press release and on Edwards' other SEC filings, all of which are available on the company's website at edwards.com. Unless otherwise noted, our commentary on sales growth refers to constant currency sales growth, which is defined in the quarterly results press release issued earlier today. Reconciliations between GAAP and non-GAAP numbers mentioned during the call are also included in today's press release. Quarterly and full year growth rates refer to continuing operations and do not include contributions from Critical Care, which was sold in Q3 of 2024 and a small noncore product group that reduces the sales of Surgical.

With that, I'd like to turn the call over to Bernard for his comments. Bernard?

Thank you, Mark. Welcome, everyone, and thank you for joining us. We have a lot to cover today, including our Q4 and full year 2024 results as well as our vision for 2025 and beyond. You will recall at the December investor conference we talked about Edward's focused strategy and our vision to solve a large complex and growing unmet patient needs in structural heart.

We have a very unique strategy to create, define and build new categories, and this will position us for extended leadership and sustainable long-term growth. Now I want to reflect on the full year 2024. It was a year of strong growth and meaningful progress for Edwards as our 16,000 employees advanced life-saving structural heart technologies for patients around the world. We are pleased with our solid 2024 full year financial performance, where sales grew 9% to $5.4 billion, in line with our original total company sales growth guidance. While we got there in a different way than we originally anticipated, with TAVR growth lower than expected, we were pleased that TMTT overachieved the expectation.

We continue to focus on the substantial long-term prospects for TAVR. And we expect TMTT to become an even more important contributor to Edwards' growth as our unique and broadening portfolio of technologies addresses the unmet needs of more patients. We made a number of strategic decisions to strengthen our company. In Q3, we completed the sale of Critical Care, and we took action to optimize Edwards in order to increase agility and accelerate innovation.

We also invested significantly in internal research and development to augment our portfolio with new breakthrough technologies. In addition, we completed the strategic acquisition of JC Medical, JenaValve and Endotronix. These acquisitions provide an expanded opportunity in new therapeutic areas to address the unmet needs of aortic regurgitation, mitral disease and heart failure patients. Together, the strategic decision and investments reinforce our confidence in Edwards sustainable long-term growth.

Turning to the fourth quarter, our first full quarter focused solely on structural heart. Total company sales grew 9%. We were pleased with our sales performance that was ahead of expectation and drove higher-than-expected earnings per share. We exited the year in a strong position with three important growth drivers, TAVR, mitral and tricuspid and two emerging opportunities, structural heart failure and AR.

Our foundation fortified by our patient-focused culture is more solid than ever and the strategic decision we made in 2024 position us well for 2025 and beyond. Looking ahead to 2025, the results of early TAVR trial represent a catalyst for improved patient care that will begin to materialize after FDA approval in mid-2025 and set the stage for guideline and policy changes in the U.S. and globally, which present a multiyear growth opportunity. In TMTT, we are transforming care for the millions of patients suffering from mitral and tricuspid valve disease. We are pleased with the impressive trajectory of our business, which is now a meaningful contributor to Edward's growth.

TMTT is on track to deliver over $500 million in sales in 2025. In Surgical, our category-leading business is positioned to grow consistently and expand globally, driven by increasing adoption of our premium Resilia-based technology in INSPIRIS, MITRIS, and KONECT. As you can see, 2025 is set to be another meaningful year for Edwards with multiple catalysts across our businesses that will contribute to our 8% to 10% total company sales growth guidance this year. And beyond 2025, Edwards will be even better position to transform care and to have a positive impact on more lives with our pioneering innovations and expanded global leadership in structural heart.

Our plan is to grow total company sales 10% annually on average with some variability based on the timing of key catalysts, while strengthening profit margins to drive long-term value for shareholders. We expect that the actions our employees around the world have taken to advance our strategy will deliver significant value to payments and the health care ecosystem. Now I'll provide some additional detail by product group for Q4 and 2024. In TAVR, our full year 2024 global sales of $4.1 billion increased 6% year-over-year. Our U.S. and OUS sales growth rates were similar.

In the fourth quarter, our global sales of $1.04 billion increased 5.3% over the prior year. Growth was driven by the U.S. and Europe. Edwards strong competitive position and pricing remained stable globally, although we experienced a few instances of regional pressure. We remain confident in our differentiated technology high-quality evidence and the value we demonstrate to patients, clinicians and health care systems.

Our commitment to advancing clinical evidence and expanding indication for patients was highlighted by results from the early TAVR trial, which were presented at the annual TCT Conference in October. Early TAVR is the first and largest randomized controlled trial to date, studying asymptomatic severe AS patient and the impact of early intervention with SAPIEN. The trial results demonstrated superior outcome for asymptomatic severe AS patients, receiving the SAPIEN platform compared with guideline recommended clinical surveillance, or simply, watchful waiting. Even patient without symptoms of severe artic stenosis have a deadly disease that can progress rapidly and in an in predictable way and require urgent treatment.

This data is compelling and should drive changes to the standard of care to streamline patient flow, improve outcomes and reduce costs to the system. In the U.S., we continue to be pleased with the performance of our market-leading SAPIEN free Ultra RESILIA platform. Capacity remains the focus as we continue to see rapid growth in structural heart procedures. In the near term, new technologies and education put pressure on the system, but in the longer term, it provides a hospital the clarity and incentive to make investments to expand their ability to treat structural heart patients.

Outside of the U.S., in the fourth quarter, sales growth was supported by the continued launch of SAPIEN 3 Ultra RESILIA in Europe. We are pleased with the exceptional patient outcomes delivered with this best-in-class platform and we expect this momentum to continue as more centers adopt the technology. Sales in Japan grew at a slower pace than in other major regions, but still increased sequentially and year-over-year. We remain dedicated to expanding this therapy to address significant undertreatment of aortic stenosis among the substantial elderly population in Japan.

Long term, outside of the U.S., we foresee excellent opportunities for growth as international adoption of TAVR therapy remains quite low in many regions. Turning to TMTT. Our unique portfolio of repair and replacement technologies for both Mitral and Tricuspid valves continues to deliver strong growth with an increasing contribution to overall company performance. The PASCAL repair system, the EVOQUE tricuspid replacement system, and the forthcoming SAPIEN M3 mitral replacement system provide the broadest set of treatment options to the many patients with varying mitral and tricuspid valve disease.

We are pleased with both our fourth quarter and full year sales result. In Q4, we reported $105 million in sales. Full year sales of $352 million increased 77% year-over-year. Sales of the PASCAL repair system and the EVOQUE tricuspid replacement system, both contributed meaningfully to growth.

PASCAL adoption is strong in both the U.S. and globally and the EVOQUE launch is expanding in the U.S. and Europe. PASCAL continues to demonstrate its value for patient care. It's differentiated features are driving excellent clinical outcome leading to increased adoption at existing centers and encouraging new centers to use the technology. The base of compelling clinical evidence is strengthening with longer-term follow-up data from randomized trials as well as new real-world evidence.

Physicians appreciate the Edwards high-touch clinical support model, which improve the efficiency of planning and performing procedures, while ensuring optimal outcome for patients. The EVOQUE commercial launch continues to progress well in the U.S. and Europe. We are investing in our field-based teams to have deep expertise and remain committed to our disciplined approach to launching the therapy, prioritizing excellent patient outcomes. We are observing strong growing in price in EVOQUE from both providers and patients, which reinforces the significant unmet needs of these patients.

We are pleased that CMS continues to develop a final national coverage determination or NCD for transcatheter Tricuspid valve replacement. We believe the policy as proposed, provides a pathway for Medicare patient access to EVOQUE. We look forward to the final NCD which we expect by the end of Q1 2025. In Mitral replacement, we continue to look forward to European approval of SAPIEN M3 by midyear 2025 with U.S. approval expected to follow in 2026. We expect the result of ENCIRCLE study, our U.S. pivotal trial studying SAPIEN M3 to be presented at this year TCT Conference in October. In summary, our bold vision for TMTT has become a reality.

We are confident in our unique portfolio strategy with repair and replacement options to treat patients suffering from Mitral and Tricuspid disease. Our full year 2025 TMTT guidance remains consistent with the expectation we laid out at our Analyst Day with sales between $500 million and $530 million, driven by our two differentiated commercial technologies, PASCAL and EVOQUE. In our Surgical product group, full year 2024 global sales of $981 million increased 6% versus the prior year. Fourth quarter global sales of $244 million increased 5% over the prior year, with healthy global adoption of Edwards premium RESILIA portfolio with MITRIS, INSPIRIS, and KONECT.

We continue to expect positive procedural growth globally for the many patients best treated surgically, including complex and concomitant procedures. We are generating evidence on the RESILIA portfolio to expand access globally, the excellent outcome of our one year multi-center real-world KONECT study were shared at the recent STS conference. In summary, before I turn the call over to Scott, we continue to expect that our full year 2025 surgical sales growth will be in the mid-single digits, driven by continued adoption of our RESILIA portfolio and growth in overall heart valve surgeries globally.

And now Scott will cover the details of the company's financial performance.

All right. Thanks a lot, Bernard. Today, I'm going to provide a wrap-up of 2024, including detailed results of our fourth quarter and guidance for the first quarter and full year of 2025. We were pleased with our better-than-expected Q4 sales performance with strength across all product groups. Total sales of $1.39 billion grew 9% on a year-over-year basis.

Adjusted earnings per share was $0.59, led by strong top line performance. GAAP earnings per share was $0.58. A full reconciliation between our GAAP and adjusted earnings per share is included with today's press release. I'll now cover additional details of our P&L. For the fourth quarter, our adjusted gross profit margin was 79% compared to 80% in the same period last year.

We continue to expect our full year 2025 adjusted gross profit margin to be between 78% and 79%. Selling, general and administrative expenses in the quarter were $492 million or 35.5% of sales compared to $417 million in the prior year. This increase in spending reflects growth in our TMTT field-based teams, transition expenses following the sale of Critical Care and strategic growth acquisitions. We plan to hold operational SG&A spending approximately flat at these levels throughout 2025 and expect a lower SG&A ratio over time.

Research and development expenses in the fourth quarter grew 12% over the prior year to $271 million or 19.6% of sales. This increase was primarily the result of a full quarter of R&D spend from previously announced acquisitions that closed in 2024. We expect to maintain R&D spending at these levels during 2025 and to moderate R&D as a percentage of sales over time. Adjusted operating profit margin in Q4 of 25.6% was in line with our expectation for the quarter. Our guidance for 2025 operating margins continues to be 27% to 28% with annual operating profit margin expansion thereafter as we outlined at the company's investor conference back in December.

Turning to taxes. Our reported tax rate this quarter was 11.6% or 13.3%, excluding the impact of special items, in line with our expectation for the quarter. For the full year 2024, our reported tax rate was 9.8% or 11.0%, excluding the impact of special items. As a reminder, our original 2024 adjusted tax rate guidance range was 14% to 17%.

And we benefited last year from several onetime tax events, resulting in a lower than originally expected rate. We continue to expect our 2025 tax rate, excluding special items, to be between 15% and 18%. Regarding tariffs, based on what we know today, our guidance ranges could accommodate any potential impact of tariffs, which we expect to be immaterial for Edwards. Foreign exchange rates increased fourth quarter reported sales growth by 60 basis points or $7 million compared to the prior year.

FX rates negatively impacted our fourth quarter gross profit margin by 30 basis points compared to the prior year. Relative to our October guidance, FX rates had a nominal impact on fourth quarter earnings per share. At current rates, we now expect FX to have an approximately $130 million or 2.5 percentage points downside to sales in 2025 compared to prior year. Turning to the balance sheet.

We continue to maintain a strong and flexible balance sheet with approximately $3 billion in cash and cash equivalents as of December 31, 2024. Average diluted shares outstanding during the quarter were $591 million. We continue to expect average diluted shares outstanding for 2025 to be between $585 million and $595 million. We have approximately $1.4 billion remaining under our current share repurchase authorization. Our healthy balance sheet gives us the flexibility to advance our growth strategy, and we look forward to a year of robust financial performance in 2025. I'll finish with comments related to guidance.

We are maintaining the financial guidance for 2025 that we provided at our December investor conference. Absent additional moves in foreign exchange, we expect total company sales of $5.6 billion to $6 billion, TAVR sales of $4.1 billion to $4.4 billion, TMTT sales of $500 million to $530 million and Surgical sales of $970 million to $1.05 billion. We expect a sequential increase in first quarter sales. We also expect Q1 total company and TAVR year-over-year growth rates to be below the low end of our full year guidance ranges of 8% to 10% and 5% to 7%, respectively.

We expect some benefit from the asymptomatic TAVR approval in the U.S. and even more support for growth when guidelines and policy change in the future. For the first quarter, we're projecting sales of $1.35 billion to $1.43 billion and adjusted earnings per share of $0.58 to $0.64. And with that, back to you, Bernard.

Thank you, Scott. In conclusion, we are proud of our employees and their significant achievement in transforming care for structural heart patients around the world. As we enter 2025, solely focused on structural heart disease, we are stronger than ever before with significant growth driver in TAVR and TMTT and emerging opportunities in other areas of structural heart. I am optimistic about the tremendous opportunities in front of us.

With that, I'll turn it back to Mark.

Thank you very much, Bernard. We're ready to take your questions. As a reminder, please limit the number of questions to one plus one follow-up to allow for broad participation. If you have additional questions, please reenter the queue and management will answer as many participants as possible during the reminder of the call. Alicia, I'll turn it back over to you

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of David Roman with Goldman Sachs. Please proceed.

Thank you, and good afternoon, everybody. I wanted just to start on the TMTT side. Maybe you could for my first question. Just help us reflect a little bit on some of the dynamics that drove the performance here in 2024 that ended above your expectations.

And then what needs to unfold operationally still to see an acceleration from kind of the $420 million where you're annualizing in Q4 up to the $500 million plus over -- that's reflected in your guidance here.

Thank you, David. Good question. So I'm going to start. If you remember, we started the year in 2024, where it was mainly PASCAL and Europe was a big contributor.

And throughout the year, EVOQUE became a growth contributor also in U.S. also for PASCAL. So if you see that this TMTT portfolio contribution is evolving. But as you can see, we are very excited. We are very pleased.

You remember, we had a vision a long time ago, and we were the only company having this vision. And this vision has become a reality. But I'm going to ask Daveen to add some color commentary here.

Yes. I'll add a little bit to that. Thanks, David for the question. As Bernard said, over the course of 2024, I think we saw the creation of a new therapy with EVOQUE, and we started treating patients, and we're starting to see that start is journey where we're still in launch mode, and we're still growing.

So as you can imagine, in 2025, EVOQUE will continue to grow. Additionally, on the PASCAL side of things, the U.S. has been -- it was probably only in the second full year of launch. And for PASCAL, we continue to open centers, both the U.S. and Europe and throughout the world and grow as physicians see the differentiation of PASCAL, they continue to use it more in their existing practice. So for us throughout 2025, PASCAL will also grow.

So we see both PASCAL and EVOQUE as two key growth drivers for us and growth also continued to come with a huge emphasis both on Europe and the U.S.

And then maybe just for my follow-up here. I'm trying to piece some of this together between how you exited Q4 and then the Q1 guidance calling for revenue growth, both in TAVR and total company below the low end of the ranges here. Because when I just reflect on Q4, you had the hurricane dynamic early in the quarter, but you also had the exit of Boston Scientific pressures in Europe, not the exit, but the pressure on their business that they described. You're seeing EVOQUE and PASCAL launch.

So just as I think about the business here, Q4 versus the dynamics that you're calling here in Q1, maybe you could just help us piece together the sequential deceleration and then correspondingly, the acceleration reflected in the full year outlook?

Thank you, David. So let me try maybe high level at the company level, then we can ask either Daveen and Larry to add some comments here. So we expect -- so first, we finished the year strong in Q4, and we are very pleased about it across the board, across the other company. We see -- we expect a sequential increase in Q1 sales, but from a growth rate standpoint, for TAVR and for the full company to be maybe below the low end of our full year ranges.

There are a few things we know in 2025. The first one is that TMTT, so PASCAL, EVOQUE are going to continue to scale throughout the year. The second one is that asymptomatic, approval midyear will represent a catalyst here later. But I'm going to add maybe Daveen to start first about TMTT scaling and then Larry.

Yes, sure. Thanks, Bernard, on that. As you imagine, over the course of 2024, you saw TMTT almost sequentially grow in a linear rate, right? We continue to add and grow each time as we got that increased adoption and entered new markets.

And for us, we see that continuing in 2025, where we expect over the course of the year, our revenue growth to just kind of linearly continue up and that will kind of lead us to our guidance.

Yes. Thanks, David. On TAVR, I think we had a good Q4, and we felt good about it. And I think it was indicative that perhaps we're starting to see a little bit of improvement in some of the capacity stuff, although it's still very much a work in progress.

I think what typically happens is, the last couple of weeks in December tend to really slow down for patient screening and those things, and that usually gives us a slow start to January. But all of that is factored into our guidance. And I think as Daveen -- sorry, as Bernard described the year, I think that's how we planned it.

Great. Thanks for all the color.

Thank you. Our next question comes from the line of Robbie Marcus with JPMorgan. Please proceed.

Great. Congrats on a nice quarter and thank for taking the questions. First for me, maybe a P&L question as we think about 2025. Scott, the mix of operating expense came in a bit different than the Street was thinking. Any color you could give us now with the rebased business ex critical care, how we should be thinking about SG&A and R&D each separately to get to the guidance you provided?

Sure. Thanks for the question. We provided guidance at the investor conference for operating profit, and we didn't really break out SG&A and R&D as a percentage of sales, but I can give you a little bit of color on how we think Q4 is going to translate into our full year 2025 operating profit. We think the improvement of about 200 basis points in operating profit versus Q4 will be about half R&D improvement as a percentage of sales, so about 100 basis points and half, SG&A as a percentage of sales, which is a combination of the actual spending that we run through that line netted with the benefit that we get from the amortization of our unfavorable contract liability that shows up in the new line in our income statement called other income.

So we're positive about the ability to improve operating margins through both SG&A and R&D management, keeping those spend levels flat in 2025 with the quarterly spend in Q4, and we're also confident about our ability to continue to grow margins in 2026 and beyond. Just as reference, our spending in 2025, will be a lower growth rate than our revenue growth rate, and that's one of the reasons why the ratio is coming down.

So to add on what Scott said, if you think about big picture here from a P&L standpoint, our number one commitment is to invest for sustainable and profitable growth. So what you can expect beyond 2025 is our EPS growing faster than our top line growth.

Great. Maybe a follow-up, Bernard, you mentioned in the script, there were a few instances of regional pressure. You still came in above The Street on TAVR. Maybe you could just speak to the regional pressures and how transient or permanent they are and also highlight some of the areas of strength. Thanks.

Yes, I was talking about a few small pockets around the globe. One is, for instance, Japan. And we look at Japan as a big growth opportunity for us. If you think about what we do as a company, anything in a structural heart disease is treating the disease of the aging.

And if there is one country where it is a perfect match between where is unmet patient need and what we do is Japan. We were not satisfied with our growth in Q4 in Japan, but we are very committed to enhance our capability in the region, bring our renovation very low faster to make sure Japan can present a growth opportunity in the years to come.

Thank you very much.

Thank you. Our next question comes from Larry Biegelsen with Wells Fargo. Please proceed.

Good afternoon and thanks for taking the questions. And Daveen, congrats on a really nice quarter in TMTT and Edwards overall. So I wanted to start with you, Daveen. That's why I pointed that out on EVOQUE, what have you seen since the NTAP started on October 1? And how are you thinking about the impact from the NCD, which should be finalized in March? And I had one follow-up.

Thanks so much Larry for the question and the nice comps you said. I'll just make one comment before I dive into the NTAP as we talk about EVOQUE. It's interesting. I've got a chance over the last couple of weeks to actually meet a handful of different EVOQUE patients and spend some time with them.

And it's amazing to hear their stories. One person who was a 62-year-old CEO of a technology staffing company, who is a biker, wake surfer and now suddenly could barely walk up the stairs and EVOQUE got him back to do the things that he wanted to do. The other person was a 79-year-old lady who was in hospice care, hospice care. And now you would never know anything is wrong with her and she is excited and happy to be alive and is actually a patient advocate for tricuspid disease now, started that recently.

And why I'm telling you the story is that these kinds of stories are what's spreading, I think, among the community, spreading among both physicians among patients. And as a result, we see a really strong demand for EVOQUE, a lot of desire from both physicians and patients because they see these excellent results for the patients or really changes their life. And it's a procedure, as we know, is very predictable. It's very -- and it gets -- we're getting clinical results in the market today or today that were similar to a clinical trial.

So for us, NTAP or the coming NCD allow more patients to access, or allow to continue the access we're seeing. So built into our guidance this year, we're assuming a positive NCD coming at the end of Q1. And I see things like NCD as potential opportunities to slow us down if they don't go as we plan. But really, we see them as continuing the growth and the opportunity for patients to get access to this product that they want. So for us, it's definitely built in.

It's definitely a part of the growth we're seeing, and it's a part of the interest we see from both physicians and patients.

That's helpful. And one for Larry. Just it would be great to hear you talk about what you're seeing and hearing in the field following early TAVR. When do you expect the data to positively impact procedures? Is it the indication? Is it guidelines? What do you need? Or is it just kind of everything kind of contributing? Thank you.

Yes, I think you're probably right on the second comment there. It's going to be a little bit of everything. I think as education expands, we're going to take opportunities that meetings like ACC and PCR to really amplify the message and make sure the referring community really understands the data and they understand the significance of the data. I think the message has moved through the implant community, but we need to move upstream to the referral community.

And so we'll be working hard to amplify that. Clearly, indication is a big thing. Once it's on label, that certainly is helpful because it gives us ability to promote directly where in how that happens, we're not allowed to promote directly. But then longer term, it's going to be guideline changes, it's going to be updates to policies and all those things.

And that's why I think we really tried to highlight this in the investor conference. We see this is going to be a multiyear catalyst. This isn't going to be short term or just one immediate bolus of patients. We see this as a long-term catalyst for us.

And certainly, if hospitals improve their capacity and as hospitals look to invest in their capacity, I think the confidence of this data and a continual stream of additional AS patients is what's going to really motivate them to make those investments.

Thanks, Larry.

Thank you. Our next question comes from Pito Chickering with Deutsche Bank. Please proceed.

Good afternoon, guys. Following up on Larry's question there. Beyond the U.S. hospitals that were part of the trial, like how many more hospitals have been trained to implant EVOQUE at this point? And any color on how many doctors at this point, including those during the trials have been trained? And I guess how many are signed up at this point to be trained at this going forward?

Yes. So this is Daveen. I'll answer that. Thanks for the question.

Yes, as you mentioned, we started off with our rollout of EVOQUE by focusing on those [indiscernible] hospitals, which is about 50 or so in the U.S. But from there, there are many other high-volume tricuspid centers. And now we've been focusing on those centers and they continue to grow. So each month, we have training programs here in Irvine and around the U.S. where more and more centers get grown.

So it's almost just a continuous kind of linear growth, but we still feel like that we're pretty early in the number of centers that are going to be training EVOQUE. We're very early in that. And so for us, it's just a linear growth, and we'll definitely continue from there.

Right. As TMTT is becoming a bigger part of the revenue engine for you guys. Can you give us a U.S., OUS split for TMTT in the fourth quarter, so you need that as a launch pad for modeling 2025? Thanks.

Yes, Daveen again. Yes, we don't break out the exact numbers. But I think as I mentioned before, right, we originally started in Europe. So Europe outside the US is still our largest market, but the U.S. is coming online. As we go forward, though, we still expect Europe to be larger, but the U.S. will be our second kind of big driver as we move forward in 2025.

Thank you. Our next question comes from the line of Travis Steed with Bank of America. Please proceed.

Hey, congrats on a good quarter. I just wanted to follow up on the Q1 guidance. You said TAVR growth below 5% to 7%. Just want to confirm first that, that 5% to 7% is constant currency. And I know there's a selling day headwind. If you could just quantify that if it's sort of 150 basis points. And excluding the selling day, are you kind of back into that kind of 5% TAVR guidance range?

Travis, you said it well, you got it exactly right. So 5% to 7% full year guidance for TAVR sales growth is an underlying constant currency basis. And the impact of the one less selling day is about 1 point, not 1.5, but around 1 point globally. And so that would take you back to somewhere close to where we ended up in Q4. 5.3% was the range.

So somewhere in that number is what we're expecting and modeling for TAVR in Q1.

Great. That's helpful. And then the second question, just so we could get an update on Class II TR, the functional mitral repair and tricuspid repair products. Just kind of curious how those trials are going and timelines for that opportunity?

Yes. No, I'll definitely call. This is Daveen again. I think as we mentioned in the investor conference back in December, the CLASP IIF pivotal trial will continue to enroll throughout 2025. So for that, we don't have any other timelines about the continued enrollment.

I would like to note though, especially at London Valves this year, actually just not that long ago, we actually showed in our MyClass study some great results for PASCAL in these FMR patients. We had over 300 patients a two year follow-up that showed an 81% MR-01, which is a great message, and we see great results from Europe. Moving over to Class II TR. So this is the tricuspid indication for PASCAL.

I think as you remember, we announced that in Q4 we did finished the enrollment. So there is a 12-month follow up on the trial, so one year follow-up. From there, it usually takes a couple of quarters to put together your PMA submission and then submit it and it's at least six months for FDA approval, so you can kind of run the timelines from there, but that was finished enrollment in Q4 2024.

Great. Thanks a lot.

Thank you. Our next question comes from the line of Vijay Kumar with Evercore ISI. Please proceed.

Hey, guys. Thanks for taking my questions. Congrats on a nice TMTT print. Maybe my first question back on the guidance here for Q1. I think Q4, when we look at the TAVR number, there were a number of one-off items, right?

I think you had three lesser days, maybe some hurricane impact to have some China noise. I guess why all of that, I think Q4 came in above expectations at 5, given some of those items won't repeat, why shouldn't Q1 be better? Is there any one-offs outside of the extra day -- one lesser day that we should be thinking of?

So Vijay, it's Scott. I'll start and then maybe turn it over to Larry, if he has any additional color. The 1 day is probably the most noteworthy thing. Remember, in our call, we had talked about the early signals from China on the hurricanes.

But at that point, I said we didn't know what the impact was going to be. Turned out that was not a big influence on our results for Q4. It had something to do with it, but I wouldn't call that exceptionally noteworthy. Really, in Q1, we're feeling good about TAVR's growth. And like I said, with the exception of that 1 day, difference in selling days versus Q4, there's not a whole lot to report.

Yes. Just to add on to that. As I mentioned earlier, we typically see a slowdown at the end of the year, and this is very typical. We've seen this for many years now.

And it just empties the funnel a little bit from the patients that are screened and having their CTs and everything. So we just typically see a little bit of a slow start to January. And so that factors into our guidance. But we do expect the growth rates to be higher in the subsequent quarters.

Understood. And Bernard, maybe my follow-up for you. I think you noted NCD language around tricuspid was in line with expectations. I think there is a CED criteria.

And when I look at the physician criteria, there is a cross-pollination collaboration between a variety of physicians rate. It seems a little bit more onerous versus when you look at the TAVR guidelines. So curious how we're thinking about the NCD proposals? And do you expect any changes to the proposed language?

No, I think we feel good about where we are with all of the progress we have made with CMS and the societies. We recommended language from CMS is aligned with our expectation. This will provide access to a Medicare patient rework, which is going to be a catalyst for the many years to come. But maybe Daveen want to add anything here?

Yes, a couple of small comments. Just obviously, when a patient as you read in the NCD is under the care of a multi-specialty heart team, and there are different kinds of members of the heart team, and that's under the care of. So that's a group of people who are not necessarily individually evaluating it. They're not necessarily part of the procedure.

They are people who as needed are part of the care program of the patient. So for us, we feel like that's been very normal and expected and actually a good thing for patients. But back to maybe Bernard's comments in the overall, we generally feel very positive about where the NCD is, we love that. We appreciate that there's coverage with evidence determination, or CED, which enables this timely access.

And we're actually quite happy or quite proud of the responsibility we have to kind of lead the CED process to gather more data and roll out this therapy. And we don't believe CED or any other parts of kind of the NCD draft that we all see online will actually affect our kind of rollout plans. It's right on line with where we had hoped the NCD would come up. So we're pretty positive on it.

Understood. Thanks for clarifying.

Thank you. Our next question comes from the line of Rick Wise with Stifel. Please proceed.

Good afternoon, everybody. Sorry, I've been in the airport, it might be a little noisy. I want to follow up one more time on the first quarter TAVR guidance and early TAVR. Scott, I just want to be clear in my own mind.

When you gave us guidance at the Analyst Day, obviously, you were thinking about the quarters of 2025. Is your -- have you shaded your TAVR expectations in some way with your comments and guided in the first quarter, is it any different than it was as the year set up, as you thought it would be back in December when we talked. And then I'll follow up on early TAVR.

Thanks for the question, Rick. No, our guidance expectations haven't really changed at all. We were pleased with the fourth quarter results. But for the reasons that Larry indicated, we still think the guidance for 2025 is the right guidance.

Q1, we knew about the one selling day back when we gave the guidance, so that's no new information. And as Larry just said, we're expecting higher growth rates in the quarters after Q1 and 2025. But really, Rick, no change in our expectations.

Okay. And Larry, just not to go over, you've been very clear, but perhaps you saw the work I did on early TAVR, just didn't tried to trona it that a bunch of docs said that they're already starting to see an increase in referral volumes. And just to ask you, even though it might be early, are you seeing -- are you hearing the same thing that I heard? I mean, obviously, as the year unfolds and as you -- as education expands, there's going to be more.

But are you seeing that same impact that, that small sample that I wrote about articulate. Thank you so much

Thanks, Rick. So we hear anecdotally. We hear about a patient there, a patient here or there. And some physicians certainly are talking more about it.

Again, the implant community is probably much more up to speed on the early tab data than the referral community is. And so it's going to take a little bit of time to get this out. I don't think there's any question that the early TAVR data is compelling and that it's going to lead to more patients coming into the system. I don't think there's any doubt about that.

I think the thing that balances that how fast can hospitals continue to address these capacity challenges, to be able to treat this additional inflow of patients. And we're working on this from a number of different angles because the other thing that comes into play is we're working on quality metrics, things like Target AS. Right now, waiting list can kind of grow in the U.S. and it's not really measured. But in the future, people are going to have quality metrics such as 90 days from diagnosis to treatment.

And I think that's going to make the difference in terms of how patients flow through the system.

Thanks, Larry. Thanks, Scott.

Thank you. Our next question comes from the line of Matt Miksic with Barclays. Please proceed.

Thanks do much for taking my question. I just have one follow-up on an earlier question. First, just around centers. I know you're growing out of the initial triennial trial centers for EVOQUE.

I'm just wondering if you have like a round number that you think this can go to Teverson centers like the 850. Is this over time, half of that? Is there a third of that, an actual number that we should just think about as getting to? And I have 1 quick follow-up, if I could.

Yes, -- this is Daveen again. It's hard to fully judge because we know it's the structural heart world of centers is kind of the TAVR world of numbers now, right, which is over 800 centers or the exact number. But we think obviously that it's going to be some portion of that, and it's going to have a kind of a track that gets up there. it's hard to figure out now how each center is going to be prepared and work together to start a tricuspid program. So it's hard to put an exact number on.

But if you put an upper bound, it's definitely probably the structural programs of 850. But I think for us, we're going to work with centers one at a time to help to get them ready, to help give them the imaging and work with them to how to get the best treatment of tricuspid disease, but yes, it's going to be a continual lender thing that we'll kind of figure out together.

Got it. And then the follow-up, just very closely related. Some of the feedback we had conversations with clinicians last year who did the launch and is obviously excitement about having to sell, but then we identify these patients, how many can you get in, the time to do the procedure, the reimbursement of the procedure, times of training, all these kinds of early sort of start-up factors. Maybe if you could talk a little bit about how you see this year your ability to sort of start mitigating some of those early kind of start-up challenges in getting volumes going and adoption going, et cetera?

Thanks so much.

Yes. And I think what the pathway of EVOQUE to treating more patients is similar to the start of any new therapy, right? We see early on that it's reproducible. It's a predictable procedure.

Please imagine the first couple of times you do and it takes a little bit longer. But then as you do a little bit more, you start getting a little better and a little bit faster at it. And similar to the pre-case planning or the referrals. As Larry said, like even with asymptomatic patients.

Initially, hey, referring physicians, they've been holding on to these tricuspid patients. They're not necessarily looking for them. But then they start seeing that tricuspid patients can be treated and are getting fantastic results. Then they start referring them.

And then initially, almost stenographers and ecosystems of hospitals, you maybe got the planning right, but you need to practice in it better, so it takes something that may be a little bit efficient and gets more efficient. So what we'll see is that the centers who have started EVOQUE or any tricuspid programs will continue to get more efficient, and we'll see that new centers that will come on new centers that will start online will take a little bit longer and do a little bit of fewer cases. Maybe I'll do one or two the first day. But now we see centers that do three to five in a day and continue in one room and continue to create that efficiency.

So I don't see this as especially unusual for a new structural heart therapy. It's in line. And we see that the -- we know that there are a lot of tricuspid patients out there and this long-term work of continuing to create awareness of this disease, diagnosis at the cardiologists, referrals to the heart teams. That's a process that the world did for TAVR.

The world did for Mitral, and we think the world will do appropriately with our support in tricuspid as well.

Very helpful. Thanks.

Thank you. Our next question comes from the line of Matthew Taylor with Jefferies. Please proceed.

Hi. Thanks for taking the question and congrats on a nice quarter. I wanted to ask a follow-up question on growth in TMTT in 2025. I know you don't give all the details of U.S., OUS or mitral tricuspid, but I was wondering if you could give us any framework or guidepost to help us understand how much growth is coming from those different sources? Or are they growing similarly?

Maybe if you could talk about share expectations in those different markets? Anything like that would be helpful to think about modeling?

So maybe let me start, Matt. We are not thinking about share. We are creating markets. The vision we had a long time ago was about creating a category.

This patient have very few options a few years ago. And with our portfolio, we have many options. And more to come with the forthcoming M3 and mitral replacement technology. So we are not thinking about share.

We are thinking about patient outcome. We are thinking about training physicians to make sure they can scale their practice. We are thinking about how to create a large category, defining in a category. And truly, this is the way we are thinking about it.

At Investor Conference, I think we gave you some vision for 2030. We believe our TMTT business could be a $2 billion business from $300 million or so last year to $500 million or so this year. clearly, clearly amazing trajectory based on all of these, but I'm going to ask Daveen to talk more about this year.

Yes. Just to give a couple more details, but I'll first add in to that. I completely agree with Bernard that for us, we know that there are just millions of patients with tricuspid and mitral disease who just can't live the quality of life that they want, and we feel like we have an opportunity to help them. And so as you move more directly in 2025, right, there are multiple drivers.

Both Europe and the U.S. will be both large growth drivers for TMTT as we -- in 2025 versus 2024. Both PASCAL and EVOQUE will be large growth drivers for TMTT in 2025 versus 2024. And the Bernard's comment just about M3, M3 was just starting in Europe. So it will be much smaller, just an initial starting. So for that, I hope that gives a little bit of help on just how we look at the two geographies and the two products and to Bernard's point, it's not about share. It's about how do we discover, find and treat just more patients and grow the overall number of procedures that can help patients.

Thank you, guys.

Thank you. Our last question comes from the line of Joanne Wuensch with Citibank. Please proceed.

Good evening and thank you for taking the question. Can we pause for a second on M3. It sounds like it's on track for CE Mark approval near the end of the year with some revenue contribution and then you're going to have data at TCT 2025. Can you remind us what that market opportunity is and why that's an important product in the portfolio?

Sure. Yes. This is Daveen as well. So just a reminder, CE Mark from M3, we expect in mid-2025 in Europe with approval in the U.S. in 2026 and the pivotal study, the InCircle study of 300 patients who were unsuitable for TR, the 1-year follow-up we expect to release at TCT this fall.

And I pressed on unsuitable for TR, I think that's really the indication of where we see M3 fitting in the treatment of patients. We know that TR is an amazing technology. and there are many patients who get fantastic results. But when you talk to physicians and you talk to patients, there are many patients who are suboptimal for TR, either anatomically or for other clinical reasons. And it's a pretty large group of patients.

There's ranges out there that we hear from many different doctors. I don't want to quote because it is pretty large ranges. And we think for that M3 really offers an opportunities to these patients to get a treatment or before they wouldn't have had one. But when we start off a new procedure and new therapy like we did with EVOQUE or like we did with any other therapy, we are going to start off by really focusing on physician training, having a great team of Edwards people supporting each case, ensuring top-notch clinical outcomes and building up a new therapy in a way that this will hopefully become a new leg to the stool of TMTT growth in the years in the future and provides multiple years of growth to get to, as Bernard said, that $2 billion of revenue in 2030.

Joanne, did you have a follow-up? Or are you good?

No, I'm good. That was awesome. Thank you so much. Have a great night.

Thank you, Joanne. I'll turn it over to Bernard for some closing comments.

Maybe some closing comments very quickly. First is we are very pleased about our strong finish to 2024 with total company sales growth of 9%. We are confident in our 2025. We are positioned for strong financial performance led by diversified source of growth, TAVR, Mitral and Tricuspid. And beyond 2025, we see an exciting future, we tackle large growing markets, and all of this will result in sustainable revenue, EPS growth and shareholder value creation.

So thank you for your continued interest in Edwards. Scott, Mark, Larry and I welcome any additional questions by telephone. Thank you, everyone. Have a good afternoon.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.