Edwards Lifesciences - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 sales were $1.386B (+9% YoY), with Transcatheter Mitral & Tricuspid Therapies (TMTT) up 88% to $105M; adjusted EPS was $0.59 and GAAP EPS $0.58, with results characterized as “better than expected” by management.
• TAVR sales reached $1.04B (+6% YoY; +5% cc), while Surgical rose to $244M (+6% YoY); strength was broad-based across U.S. and Europe, with Japan slower but improving sequentially.
• 2025 guidance reaffirmed: 8–10% constant currency sales growth, adjusted EPS $2.40–$2.50; product group ranges: TAVR $4.1–$4.4B, TMTT $500–$530M, Surgical $970M–$1.05B; Q1 2025 guidance $1.35–$1.43B sales, adjusted EPS $0.58–$0.64.
• Catalysts: mid‑year asymptomatic TAVR U.S. indication approval, CMS NCD for EVOQUE (expected by end of Q1), and continued European rollout of SAPIEN 3 Ultra RESILIA; management positions these as multi‑year growth drivers.

What Went Well and What Went Wrong

What Went Well

• TMTT momentum: Q4 TMTT sales surged to $105M (+88% YoY), with strong adoption of PASCAL and EVOQUE; management expects $500–$530M TMTT sales in FY25, underscoring category creation and portfolio differentiation.
• Practice‑changing evidence: TRISCEND II showed EVOQUE superiority over medical therapy at one year, with 95.3% achieving ≤ mild TR; principal investigators highlight QoL benefits and favorable mortality/hospitalization trends.
• Broad‑based sales strength: Q4 sales grew 9% to $1.386B, with U.S. +9.2% and Europe +13.6% (10.7% cc), supported by SAPIEN 3 Ultra RESILIA adoption; adjusted operating margin of 25.6% in line with plan.

What Went Wrong

• Margin compression: Gross margin fell to 78.9% (79.0% adjusted) vs 80.2% prior-year; SG&A rose to 35.5% of sales and R&D to 19.6%, reflecting TMTT field expansion, post‑Critical Care transition costs, and acquisitions.
• Capacity and regional pressure: Management cited ongoing hospital capacity constraints and “a few instances of regional pressure,” notably slower-than-expected growth in Japan despite sequential improvement.
• Near‑term growth cadence: Q1 2025 total company and TAVR YoY growth expected below the low end of full-year ranges, with one fewer selling day and typical January funnel reset noted by management; FX headwind of ~$130M projected for FY25.

Transcript

Mark Wilterding (Head of IR)

During today's call, management will discuss the results 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 non-core product group that reduces the sales of Surgical. With that, I'd like to turn the call over to Bernard for his comments. Bernard?

Bernard Zovighian (CEO)

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 Edwards' focus 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 lifesaving 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 expectations. 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 acquisitions of JC Medical, Innovalve, 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, these strategic decisions 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 expectations 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 positions us well for 2025 and beyond.

Looking ahead to 2025, the results of an 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 multi-year growth opportunity. In TMTT, we are transforming care for the millions of patients suffering from mitral and Tricuspid valve diseases. We are pleased with the impressive trajectory of the business, which is now a meaningful contributor to Edwards' 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%-10% total company sales growth guidance this year, and beyond 2025, Edwards will be in an 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 patients and the healthcare 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 US and ex-US 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 US and Europe. Edwards' strong competitive position and pricing remain 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 healthcare systems. Our commitment to advancing clinical evidence and expanding education 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 patients and the impact of early intervention with SAPIEN.

The trial results demonstrated superior outcomes for asymptomatic severe AS patients receiving the SAPIEN platform compared with guideline-recommended clinical surveillance, or simply watchful waiting. Even patients without symptoms of severe aortic stenosis have a deadly disease that can progress rapidly and in an unpredictable 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 3 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 hospitals 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 year over year. We remain dedicated to expanding this therapy to address significant under-treatment 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 results. 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 US and globally, and the EVOQUE launch is expanding in the US and Europe. PASCAL continues to demonstrate its value for patient care. Its differentiated features are driving excellent clinical outcomes, 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 improves the efficiency of planning and performing procedures while ensuring optimal outcomes 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 interest 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 mid-year 2025, with U.S. approval expected to follow in 2026. We expect the result of the ENCIRCLE study, our U.S. pivotal trial studying SAPIEN M3, to be presented at this year's 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 was 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.

Scott Ullem (CFO)

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%-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%-17%, and we benefited last year from several one-time 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 the 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 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-$6 billion, TAVR sales of $4.1-$4.4 billion, TMTT sales of $500-$530 million, and Surgical sales of $970 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%-10% and 5%-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-$1.43 billion and adjusted earnings per share of $0.58-$0.64. And with that, back to you, Bernard.

Bernard Zovighian (CEO)

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 drivers 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 turn it back to Mark.

Mark Wilterding (Head of IR)

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 re-enter the queue, and management will answer as many participants as possible during the remainder of the call. Alicia, I'll turn it back over to you.

Operator (participant)

Thank you. We will now be conducting a question-and-answer session. Just as a reminder, if you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Thank you.

Our first question comes from the line of David Roman with Goldman Sachs. Please proceed.

David Roman (Managing Director)

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 year in 2024 that ended up 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 that's reflected in your guidance here?

Bernard Zovighian (CEO)

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, you know, a growth contributor also and the US also for PASCAL.

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 the 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 David to add some color commentary here.

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

Yeah, 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 the start of a 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., as Bernard said, was probably only in the second full year of launch. And for PASCAL, we continue to open new 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 continuing to come with a huge emphasis both on Europe and the U.S.

David Roman (Managing Director)

And 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 in 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's pressures in Europe, not their 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.

Bernard Zovighian (CEO)

Yeah, thank you, David. So let me try maybe high level at the company level, and then we can ask you, 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 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 and EVOQUE, are going to continue to scale throughout the year. The second one is that asymptomatic approval mid-year will represent a catalyst later. But I'm going to add maybe Daveen to start first about TMTT scaling, and then Larry.

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

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

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'll kind of lead us to our guidance.

Larry Wood (CVP of Transcatheter Heart Valves)

Yeah, thanks, David. On TAVR, I think we had a good Q4, and we felt good about it. 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 or sorry, as Bernard described the year, I think that's how we planned it.

David Roman (Managing Director)

Great. Thanks for all the color.

Operator (participant)

Thank you. Our next question comes from the line of Robert Marcus with J.P. Morgan. Please proceed.

Robert Marcus (Medtech Senior Analyst)

Oh, great. Congrats on a nice quarter, and thanks for taking the question. 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 three-base business ex Critical Care, how we should be thinking about SG&A and R&D each separately to get to the guidance you provided?

Scott Ullem (CFO)

Yeah, 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.

Bernard Zovighian (CEO)

So to add on what Scott said, if you think about the 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.

Robert Marcus (Medtech Senior Analyst)

Great. Thank you. And 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.

Bernard Zovighian (CEO)

Yeah, 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 structural heart disease is treating the disease of aging. And if there is one country where it is a perfect match between where is the 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 to bring our innovation there faster, to make sure Japan can represent a growth opportunity in the years to come.

Robert Marcus (Medtech Senior Analyst)

Thank you very much.

Operator (participant)

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

Larry Biegelsen (Senior Analyst)

Good afternoon. Thanks for taking the question. And Daveen, congrats on a really nice quarter in TMTT and Edwards overall.

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 1st, and how are you thinking about the impact from the NCD, which should be finalized in March? And I had one follow-up.

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

No, thanks so much, Larry, for the question and the nice comments 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 was a 62-year-old CEO of a technology staffing company who was a biker, a wakesurfer, and now suddenly could barely walk up the stairs.

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, and now you would never know anything is wrong with her. And she's 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 these stories is that these kinds of stories are what's spreading, I think, among the community, spreading among both physicians and 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 it really changes their life. And it's a procedure that, as we know, is very predictable.

We're getting clinical results in the market today, that were similar to our clinical trial. So for us, NTAP or the coming NCD allow more patients access or allow to continue the access we're seeing. Built into our guidance this year, we assume a positive NCD coming at the end of Q1. I see things like the NCD as potential opportunities to slow us down if they don't go as we planned, but really we see them as continuing the growth and the opportunity for patients to get access to this product that they want. 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.

Larry Biegelsen (Senior Analyst)

That's helpful.

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.

Larry Wood (CVP of Transcatheter Heart Valves)

Yeah, Larry, 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 at 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, the indication is a big thing. Once it's on label, that certainly is helpful because it gives us the ability to promote directly, where until 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 as going to be a multi-year catalyst. This isn't going to be a short term or just one immediate bolus of patients. We see this as a long-term catalyst for us. And certainly, as 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.

Larry Biegelsen (Senior Analyst)

Thanks, Larry.

Operator (participant)

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

Pito Chickering (Analyst)

Good afternoon, guys. Following up on Larry's question there, beyond the US hospitals that were part of the trial, 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 going forward?

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

Yeah, so this is Daveen. I'll answer that. Thanks for the question. Yeah, as you mentioned, we started off with our rollout of EVOQUE by focusing on those TRISCEND II hospitals, which is about 50 or so in the US. 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 trained. 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 trained in EVOQUE. We're very early in that. And so for us, it's just a linear growth, and we'll definitely continue from there.

Pito Chickering (Analyst)

Great. As TMTT is becoming a bigger part of the revenue engine for you guys, can you give us an ex-US for U.S. split for TMTT on the fourth quarter so we can use that as a launchpad for modeling 2025? Thanks.

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

Yes, Daveen again. Yeah, 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 US is coming online. As we go forward, though, we still expect Europe to be larger, but the US will be our second kind of big driver as we move forward in 2025.

Operator (participant)

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

Travis Steed (Managing Director)

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

Larry Wood (CVP of Transcatheter Heart Valves)

Travis, you said it well. You got it exactly right.

So 5%-7% full-year guidance for TAVR sales growth is on an underlying constant currency basis. And the impact of the one less selling day is about a point, not a point and a half, but around a 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 neighborhood is what we're expecting and modeling for TAVR in Q1.

Travis Steed (Managing Director)

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

Scott Ullem (CFO)

Yeah, no, I'll definitely follow that with Daveen again.

I think as we mentioned in the investor conference back in December, the CLASP II F pivotal trial will continue to enroll throughout 2025. So for that, we don't have any other timelines, but 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 MiCLASP study some great results for PASCAL in these FMR patients. We had over 300 patients at two-year follow-up that showed an 81% MR01, which is a great message, and we see great results from Europe. Moving over to CLASP II TR, so this is the Tricuspid indication for PASCAL. I think, as you remember, we announced that in Q4, we did finish 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.

Travis Steed (Managing Director)

Great. Thanks a lot.

Operator (participant)

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

Vijay Kumar (Senior Managing Director and Equity Research Analyst)

Hey, guys, thanks for taking my question. And congrats on a nice TMTT print. Maybe my first question back on the guidance here for Q1. I think Q4, when we looked at the TAVR number, there were a number of one-off items, right? I think you had three lesser days, maybe some hurricane impact. I think there was some China noise. Despite all of that, I think Q4 came in about expectations at five.

Given some of those items, one 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?

Scott Ullem (CFO)

So, Vijay, Scott, I'll start and then maybe turn it over to Larry if he has any additional color. The one day is probably the most noteworthy thing. Remember, in our call, we had talked about the early signals from China and the hurricanes, but at that point, said we didn't know what the impact was going to be. It turned out that was not a big influence on our results for Q4. It just 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 one-day difference in selling days versus Q4, there's not a whole lot to report.

Larry Wood (CVP of Transcatheter Heart Valves)

Yeah, 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.

Vijay Kumar (Senior Managing Director and Equity Research Analyst)

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 the CED criteria.

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

Bernard Zovighian (CEO)

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

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

Yeah, a couple of small comments.

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

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. 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 in line with where we had hoped the NCD would come up. We're pretty positive on it.

Vijay Kumar (Senior Managing Director and Equity Research Analyst)

Understood. Thanks for clarifying.

Operator (participant)

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

Rick Wise (Managing Director)

Good afternoon, everybody. Sorry, I'm in an 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, 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. Have you shaded your TAVR expectations in some way with your comments and guide in the first quarter? Is it any different than it was? Where is 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.

Scott Ullem (CFO)

Well, 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 then, as Larry just said, we're expecting higher growth rates in the quarters after Q1 in 2025.

But really, Rick, no change in our expectations.

Rick Wise (Managing Director)

Okay. And Larry, just not to go over it, you've been very clear, but perhaps you saw the work I did on EARLY TAVR. Just didn't try to force it, but 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 education expands, there's going to be more. But are you seeing that same impact that that small sample that I wrote about articulated? Thank you so much.

Larry Wood (CVP of Transcatheter Heart Valves)

Thanks, Rick. 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 TAVR 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 is 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 lists 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 a big difference in terms of how patients flow through the system.

Rick Wise (Managing Director)

Thanks, Larry. Thanks, Scott.

Operator (participant)

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

Matt Miksic (Equity Research Analyst)

Hey, thanks so much for taking the question. Just have one follow-up on an earlier question first. Just around centers, I know you're growing out of the initial TRISCEND clinical trial centers for EVOQUE. I'm just wondering, if you have a round number that you think this can go to, TAVR centers went to 850. Is this over time? Half of that? Is it a third of that? Any natural number that we should just think about getting to? And then I have one quick follow-up, if I could.

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

Yeah, no, this is Daveen again. Thanks for the question. It's hard to fully judge because we know 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 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 we 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 yeah, it's going to be a continual linear thing that we'll kind of figure out together.

Matt Miksic (Equity Research Analyst)

Got it. And then the follow-up, just very closely related, some of the feedback we had in our conversations with clinicians last year in the early days of the launch is obviously excitement about having this valve, but then can we identify these patients? How many can get in? The time to do the procedure, the reimbursement for the procedure, time for training, all these kinds of early sort of startup 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 startup challenges and getting volumes going and adoption going, etc. Thanks so much.

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

Yeah. 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 a reproducible. It's a predictable procedure. But you can imagine the first couple of times you do it, it takes a little bit longer. But then as you do a little bit more, you start getting a little bit faster at it. And it's similar to the pre-case planning or the referrals. As Larry said, 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, in most centers and ecosystems of hospitals, you maybe got the planning right, but you need to practice and get better. So take something that may be a little bit inefficient 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 up, new centers that will start online, will take a little bit longer and do a little bit fewer cases. Maybe they'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 we know that there are a lot of Tricuspid patients out there. And this long-term work of continuing to create awareness for the 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.

Matt Miksic (Equity Research Analyst)

Thanks.

Operator (participant)

Thank you. Our next question comes to the line of Matt Taylor with Jefferies. Please proceed.

Matt Taylor (Managing Director)

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, US, OUS, or Mitral, Tricuspid, but I was wondering if you could give us any framework or guideposts 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 to see.

Bernard Zovighian (CEO)

So maybe let me start, Matt. We are not thinking about share. We are creating a market. The vision we had a long time ago was about creating a category. This patient had a very few options a few years ago. And now, with our portfolio, they have many options. And more to come with the forthcoming M3, 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 the category. 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. So clearly, clearly, an amazing trajectory based on all of these. But I'm going to ask Daveen to talk more about this year.

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

Yeah, just to give a couple more details, but I'll first add into 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.

We feel like we have an opportunity to help them. So as we move more directly in 2025, right, there are multiple drivers. Both Europe and the US will be both large growth drivers for TMTT in 2025 versus 2024. Both PASCAL and EVOQUE will be large growth drivers for TMTT in 2025 versus 2024. To Bernard's comment just about M3, M3 will just be starting in Europe, so it will be much smaller, just an initial starting. For that, I hope that gives a little bit of help on just how we look at the two geographies and the two products. 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.

Matt Taylor (Managing Director)

Great. Thank you, guys.

Operator (participant)

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

Joanne Wuensch (Managing Director)

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?

Daveen Chopra (CVP, TMTT, Surgical and IHFM)

Sure. Yeah. This is Daveen as well. So just a reminder, CE mark for M3, we expect in mid-2025 in Europe with approval in the US in 2026. And the pivotal study, the ENCIRCLE study of 300 patients who were unsuitable for TEER, the one-year follow-up we expect to release at TCT this fall.

I pressed on unsuitable for TEER, so I think that's really the indication of where we see M3 fitting in in the treatment of patients. We know that TEER 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 TEER, either anatomically or for other clinical reasons. 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. We think for that, M3 really offers an opportunity to these patients to get a treatment where before they wouldn't have had one.

But when we start off a new procedure or a 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. Yeah.

Mark Wilterding (Head of IR)

Maybe. Joanne, did you have a follow-up, or are you good?

Joanne Wuensch (Managing Director)

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

Mark Wilterding (Head of IR)

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

Bernard Zovighian (CEO)

Yeah, no, thank you. Maybe some closing comments very quickly.

First, 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, Sidney, and I. Welcome any additional questions by telephone. Thank you, everyone. Have a good afternoon.

Operator (participant)

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