Edwards Lifesciences Corp
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
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30.2% overvaluedEdwards Lifesciences Corp (EW) — Q4 2024 Earnings Call Transcript
AI Call Summary AI-generated
The 30-second take
Edwards Lifesciences reported solid yearly results, driven by strong growth in its newer mitral and tricuspid valve therapies. The company is optimistic about the year ahead, expecting multiple new product launches and studies to fuel growth, though it cautioned that growth early in 2025 might be a bit slower.
Key numbers mentioned
- Full year 2024 sales grew 9% to $5.4 billion.
- TMTT full year 2024 sales were $352 million, a 77% year-over-year increase.
- TMTT 2025 sales guidance is between $500 million and $530 million.
- Q4 2024 TAVR sales were $1.04 billion, a 5.3% increase.
- Q4 2024 adjusted earnings per share was $0.59.
- 2025 total company sales growth guidance is 8% to 10%.
What management is worried about
- TAVR growth in 2024 was lower than originally expected.
- Sales in Japan grew at a slower pace than in other major regions.
- In the near term, new technologies and education put pressure on the hospital system's capacity.
- Foreign exchange rates are expected to have an approximately $130 million downside to sales in 2025.
What management is excited about
- The TMTT business is on track to deliver over $500 million in sales in 2025.
- The results of the early TAVR trial represent a catalyst for improved patient care and a multiyear growth opportunity.
- The EVOQUE commercial launch continues to progress well in the U.S. and Europe with strong growth in demand.
- The company expects European approval of the SAPIEN M3 mitral replacement system by midyear 2025.
- Edwards plans to grow total company sales 10% annually on average while strengthening profit margins.
Analyst questions that hit hardest
- David Roman — Analyst: Quarterly growth dynamics and guidance. Management gave a high-level overview and attributed the Q1 deceleration to typical seasonal patterns, with different executives adding color on TMTT scaling and TAVR capacity.
- Vijay Kumar — Analyst: Q1 TAVR performance versus Q4. The CFO stated the one fewer selling day was the most noteworthy factor, and another executive cited a typical post-holiday slowdown in patient screening as a reason factored into guidance.
The quote that matters
Our bold vision for TMTT has become a reality.
Bernard Zovighian — CEO
Sentiment vs. last quarter
This section is omitted as no previous quarter context was provided.
Original transcript
Operator
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 Edwards' focused strategy and our vision to solve 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 decisions we made in 2024 position us well for 2025 and beyond. Looking ahead to 2025, the results of early TAVR trials 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 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% to 10% total company sales growth guidance this year. And beyond 2025, Edwards will be even better positioned 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 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 healthcare systems. Our commitment to advancing clinical evidence and expanding indications 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 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 hospitals with 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 for 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. 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 growth in demand for 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 results 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.
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%. 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 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.
Operator
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 remaining call. Alicia, I'll turn it back over to you.
Thank you, and good afternoon, everyone. To begin with, I would like to focus on the TMTT sector. For my first question, could you help us understand the dynamics that contributed to your performance in 2024, which surpassed your expectations? Additionally, what operational developments are still needed to achieve an acceleration from the $420 million you're annualizing in Q4 to over $500 million, as indicated in your guidance?
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 the U.S. and also for PASCAL. So, as you can see, 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 as 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. 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. Let me provide a high-level overview at the company level, and then we can have Daveen and Larry add their insights. We finished the year strong in Q4, and we are very pleased across the board. We anticipate a sequential increase in Q1 sales, but the growth rate for TAVR and the company as a whole may fall below the lower end of our full year projections. Looking ahead to 2025, we expect that TMTT, including PASCAL and EVOQUE, will continue to scale throughout the year. Additionally, the approval for asymptomatic cases midyear will act as a catalyst. I will now turn it over to Daveen to discuss TMTT scaling before we hear from 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, thank you, David. Regarding TAVR, we believe we had a solid Q4, and we are optimistic about it. It suggests that we might be beginning to see some improvement in capacity issues, although it's still a work in progress. Typically, the last couple of weeks of December see a slowdown in patient screening, which usually results in a slow start to January. However, we have accounted for all of this in our guidance. As Bernard mentioned about the year, that is how we have structured our plans.
Great. Congrats on a nice quarter and thank you 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.
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.
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 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, it 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.
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.
Thank you, Larry, for your question and your kind words. Before I address the NTAP in relation to EVOQUE, I want to share something. Recently, I met with several EVOQUE patients, and their stories are truly remarkable. One individual, a 62-year-old CEO of a technology staffing firm who enjoys biking and wake surfing, found himself struggling to walk up stairs, but EVOQUE helped him return to his active lifestyle. Another was a 79-year-old woman in hospice care who now appears vibrant and is thrilled to be alive, even becoming an advocate for tricuspid disease. The reason I’m sharing these experiences is to highlight the positive narratives spreading throughout the community among both doctors and patients. Consequently, we are witnessing strong demand for EVOQUE, driven by the impressive results that significantly improve patients' lives. The procedure is highly predictable, yielding clinical outcomes comparable to those from clinical trials. Therefore, we anticipate that NTAP and the forthcoming NCD will enhance patient access, which is factored into our guidance for this year, expecting a favorable NCD at the end of Q1. While we recognize that NCD could pose challenges if they don't progress as anticipated, we view them as ongoing growth opportunities and a means for more patients to access the treatments they need. This demand is a critical element of our growth strategy and reflects the interest of both healthcare providers 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 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 the 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 as 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 in this data and a continual stream of additional AS patients is what's going to really motivate them to make those investments.
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, 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 flagship 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 are being 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 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. 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 U.S. 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.
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 on 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 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.
Thank you for taking my questions. Congratulations on a strong TMTT performance. For my first question regarding guidance for Q1, I noticed that in Q4, there were several one-time items impacting the TAVR numbers. There were three fewer days and some hurricane effects, along with some issues in China. Despite these factors, Q4 exceeded expectations at 5. Considering that some of these items are not likely to occur again, why shouldn't Q1 perform even better? Are there any other one-time factors, aside from the extra day and one fewer day, that we should be aware 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. It 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.
Thanks, Larry. We are proud of the results of our team in 2024, and we are looking forward to continuing our focus on patient outcomes and innovation in the field of structural heart.