Edwards Lifesciences Corporation Price & Performance (EW)

Bernard? Thank you, Mark. 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 EnWorld's Edwards 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 5,400,000,000.0 in line with our original total company sales growth guidance. While we got there in a different way that we originally on with tougher growth lower than expected we were pleased that TMTT overachieved expectation. We continue to focus on the substantial long term prospects for TAVR And we expect TNT 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 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 Jesse Medical, Innovarve and EndoTronics. 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 Edvard's sustainable long term growth. Turning to the fourth quarter. Our first full quarter for KUSOLIEN Structable 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. Tower, Mitel and tracker speed 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-twenty twenty five 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 of over millions of patients suffering from mitral and tricuspid valve diseases. We are pleased with the impressive trajectory of our business. Which is now a meaningful contributor to Eduardo's growth. TMT is on track to deliver over $500,000,000 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, Inspiris, MITREIS and Connect. As you can see, twenty twenty five 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, [indiscernible] 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 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 twenty twenty four.

In Terra, our full year 2024 global sales of €4,100,000,000 increased 6% year over year. Our U. S. And OUS sales growth [indiscernible] [indiscernible] In the fourth quarter, our global sales of $1,040,000,000 increased 5.3% over the prior year. Growth was driven by The U. S. And Europe, Edvard's 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 a result from the early TAVR trial. Which we have presented at the Annual TCT Conference in October. Early TAVR is the first and largest randomized controlled trial to date, studying asymptomatic severe AF 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 patients without symptom 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, [indiscernible] to the system.

In The U. S, We continue to be pleased with the performance of our market leading sebion free ultra resiliya platform. Capacity remains a focus, as we continue to see rapid growth in structural health procedures, In the near term, new technologies and education put pressure on the system But in the longer term, it provide hospital the clarity and incentive to make investment, 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 Sapiens [indiscernible] 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 dry casted valves continues to deliver strong growth with an increasing contribution to overall company performance.

The Pascal repair system the Evoque Tricuspid replacement system, Mitel replacement system provides a broader set of treatment option to the many patient with varying mitral and tricuspid valve disease. [indiscernible] We are pleased with both our fourth quarter and full year sales results. In Q4, we reported [indiscernible] full year sales of €352,000,000 in 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 Evoqu launch is expanding in The U. S. And Europe. Pascal continue demonstrate his value for patient care. Its 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 Edward's high touch clinical support mode 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.

Protea is seeing excellent patient outcomes. We are serving 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 trachuspid valve replacement. We believe the policy as proposed provides a pathway for Medicare patient access to Evoqu. We look forward to the final NCD, which we expect by the end of Q1 twenty twenty five. [indiscernible] we continue to look forward to European approval of CPNM by midyear twenty twenty five, with U. S. Approval expected to follow in 2026. We expect the result [indiscernible] our U. S. Pivotal trial studying sapienM3 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 Faucet disease Our full year 2025 TNTT guidance remains consistent with the expectation we laid out at our Analyst Day. With sales between €500,000,000 and $530,000,000 driven by our two differentiated commercial technologies: Pascal and Evoc. In our Surgical Product Group, full year 2024 global sales of of €981,000,000 increased 6% versus the prior year. Fourth quarter global sales of €244,000,000 increased 5% over the prior year. With healthy global adoption of Edwards premium Resilia portfolio, [indiscernible] and Connect, We continue to expect positive positive 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 multicenter [indiscernible] where 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 $1,390,000,000 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 and L. For the fourth quarter, our adjusted gross profit margin was 79%, compared to 80% the same period last year. We continue to expect our full year 2025 adjusted gross profit margin to be between 7879%. Selling, general and administrative expenses in the quarter were $492,000,000 or 35.5% of sales, compared to $417,000,000 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 and A spending approximately flat at these levels, and expect a lower SG and A ratio over time.

Research and development expenses in the fourth quarter grew 12% over the prior year to $271,000,000 or 19.6% of sales. This increase was primarily the result of a full quarter of R and D spend from previously announced acquisitions that closed in 2024. We expect to maintain R and D spending at these levels. During 2025 and to moderate R and D as a percentage of sales over time. Adjusted operating profit margin in 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% 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 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 1518%.

Regarding tariffs, our guidance ranges could accommodate any potential impact of tariffs which we expect to be immaterial for Edwards Edwards. Foreign exchange rates increased fourth quarter reported sales growth by 60 basis points or $7,000,000 compared to the prior year. 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 $130,000,000 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 $3,000,000,000 in cash and cash equivalents As of 12/31/2024. Average diluted shares outstanding during the quarter were $591,000,000 We continue to expect average diluted shares outstanding for 2025 to be between $585 and $595,000,000 We have approximately $1,400,000,000 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 $5,600,000,000 to $6,000,000,000 TAVR sales of $4,100,000,000 TMTT sales of $500,000,000 to $530,000,000 Surgical sales of $9.70 to $1,050,000,000 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 105% 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 the future. For the first quarter, we're projecting sales of $1,350,000,000 to $1,430,000,000 adjusted earnings per share of $0.58 to $0.64 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 patient 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 Marc. Thank you very much, Bernard.

Ready to take your questions. Plus one follow-up to allow for broad participation. Possible during the remainder of the call. Alicia, I'll turn it back over to you.

Thank you. We will now be conducting a question and answer session. 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 $420,000,000 where you're annualizing in Q4 up to the $500,000,000 plus over the 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, [indiscernible] and U. S. Also for Pascal. So if you see that this TMT TTT portfolio contribution is evolving, But as you can see, we are very excited We are very pleased. You remember we had a vision 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.

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 Evoqua. And we started treating patients and we're starting to see that start as journey. 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 as physicians see the differentiation of PASCAL, they continue to use it more their existing practice. So for us throughout 2025, Pascal will also grow. So we see both Pascal and Evoke as two key growth drivers for us and growth also continued to come with huge emphasis both on Europe And then maybe just for my follow-up here, I'm trying to piece some of this together between how you exited Q4 then the Q1 guidance calling for revenue growth both in TAVR and total company below below 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 Evoqua 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 you, Devine 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. A your other boards, across your 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 few things we know in 2025. The first one is that TMT, so Pascal and 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 [indiscernible] Devine 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 On TAVR, I think we 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 Bernard described the year, I think that's how we planned it.

Great. Thanks for all the color.

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

Great. Congrats on a nice quarter and thanks for taking the First for me, maybe a P and 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 rebase business ex Critical Care, how we should be thinking about SG and A and R and 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 and A and R and 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 and D improvement as a percentage of sales, so about 100 basis points and half SG and 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 live [indiscernible] So we're positive about the ability to improve operating margins through both SG and A and R and 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 referenced, our spending in 2025 will be a lower growth rate than our revenue growth rate and that's one of the reasons ratio is coming down.

So to add on what Scott said, if you think about picture here from a P and 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. And maybe if follow-up. Bernard, you mentioned in the script there were a few in 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 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 growth in Q4 in Japan. But we are very committed to enhance our capability in the region to bring our renovation very little faster, to make sure Japan can represent the growth opportunity in the years to come. Thank you.

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

Good afternoon. Thanks for taking the question.

And Devine, congrats on a really nice quarter in TMTT and Edwards overall.

I wanted to start with you, Devina, that's why I pointed that out on Evoke.

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.

No. 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 of O patients and spend some time with them. 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 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's and happy to be alive and is actually a patient advocate for Tricuspid disease now started out recently. And why I'm telling this 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 Evoqua. A lot of desire from both physicians and patients because they see these these excellent results for the patients or it really changes their life.

And it's a procedure that 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 access or allow to continue the access we're seeing. So built into our guidance this year, we assume a positive NCD coming at the end of Q1.

And 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. 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 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. Larry, I think you're probably right on the second comment there is, 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 the referral community. And so we'll be working hard to 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 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 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 a 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 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, 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 Devine.

I'll answer that. Thanks for the question. Yes, as you mentioned, we started off with our rollout of Evoqua by focusing on those Tricent do half 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 them up. We are we're very early in that. And so for us, just a linear growth and we'll definitely continue from there.

Right. As TMGT is becoming a bigger part of the revenue engine for you guys, can you give us a U. S. Versus OUS split for TMTT on the fourth quarter, so you can use that as a launch pad for modeling 2025 Thanks.

Yes, Devine 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.

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

Hey, congrats on the good quarter. I just wanted to follow-up on the Q1 guidance You said powder 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, I don't know if it's around 150 basis points.

Excluding the sell and day, are you kind of back into that kind of 5% TAVR guide [indiscernible] 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 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 is what we're expecting and modeling for TAVR in Q1.

Great. That's helpful. And then the second question, will get an update on Class 2F and Class 2TR, the functional mitochondrial repair and tricuspid repair products. Just kind of curious where how those trials are going and timelines for that opportunity?

I think as we mentioned in investor conference back in December, the Class 2F pivotal trial will continue to enroll throughout 2025. So for that, we don't have any other [indiscernible] I would like to note though, especially at London valves this year, actually just not that long ago, we actually showed our MYCLOS study some great results for PASCAL in these FMR patients. We had over 300 patients at two year follow-up that showed an eighty one percent MR-one, 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 finish the enrollment. So there is a twelve month follow-up on the trial, so one year follow-up. From there, it usually takes a couple of quarters to put together your PMAs, so [indiscernible] you can kind of run the timelines from there, but that was finished enrollment in Q4 twenty twenty four? Great. Thanks a lot.

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

Guys. Thanks for taking my question and congrats on a nice TMTT front.

Maybe my first question back on the guidance here for Q1. I think Q4 when we look at the tower number, there were a number of one off items right? I think you had three lesser days, maybe some hurricane impact.

Some China noise. Despite all of that, I think Q4 came in about expectations at five.

Given some of those items won't repeat, why shouldn't Q1 be better Is there any one offs outside of the extra data one lesser data 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 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. 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 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.

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 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 here. 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, right? It seems a little bit more onerous versus when we 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. We sort of progress we have made with CMS and the societies. With the recommended language from CMS is aligned with our expectation. This will provide access to a Medicare patient to Evoqu, which is going to be a catalyst for the many years to come. But maybe Devine, you want to add anything? 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 specialty heart team, there are different kinds of members of the heart team and that's under the CARO. So that's 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 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 CD, which enables this timely access And we're actually quite happy or quite proud of the responsibility we have to kind of lead the CD process to gather more data and roll out the therapy. And we don't believe CD or any other parts of kind of the NCD draft that we all see it online will actually affect our kind of roll out plans. It's It's right online with where we had hoped the NCD would come up. So we're pretty proud Thanks for clarifying.

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

Good afternoon, everybody. Sorry, I'm in an airport 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 [indiscernible] when you gave us guidance at the Analyst Day, obviously, you were thinking about the quarters of '25 Is your 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 versus the year setup as you thought it would be back in December when we talked? And then I'll follow-up on early tablet.

Thanks for the question, Rick. No, our guidance expectations haven't really changed at all.

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 in 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. It just didn't try to force it that a bunch of docs said that they're already starting to see 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 [indiscernible] Thank you so much.

Thanks, Rick. We hear anecdotally, we hear about a patient 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 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 list can kind of grow in The U. S. And it's not really measured.

But in The in the future, people are going to have quality metrics such as ninety 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. Thanks Larry. Thanks, Scott.

Thank you.

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

Just have one follow-up on an earlier question First, just around centers, I know you're growing out of the initial Trisense clinical trial centers for [indiscernible] if you have like a a round number that you think this can go to, TevaSense is worth $850,000,000 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.

Yes. This is Devine again. Thanks for the question. It's hard to fully judge because we know it's the structural heart world of centers is kind of a 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 to start a tricuspid program. So it's hard to put exact number on, but if we put an upper bound, it's definitely probably the structural programs of eight fifty. 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 of tricuspid disease. But it's going to be a continual inner 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 our conversations with clinicians last year and the early days of the launch and is obviously excited 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 start up back 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 in about it going, etcetera? Thanks so much. Yes.

And I think what the pathway of Evoke to be 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. Please imagine the first couple of times you do it, it takes a little bit longer. Then as you do a little bit more, you start getting a little better and a little bit faster at it. And it's 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. Then you 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 may be got the planning right, but you need to practice and get better. So take something that maybe a little bit 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 [indiscernible] We'll see that new centers that will come on new centers that will [indiscernible] we'll take a little bit longer and do a little bit of fewer cases.

Maybe we'll do one or two the first day. We now we see centers that do three to five in a day and continue to 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 there we know that there are a lot of tricuspid patients out there. And this long term work of continuing to create awareness for this disease diagnosis of 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.

Thank you. Our next question comes from the line of Matt Taylor with Jefferies.

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 twenty twenty five. Know you don't give all the details U. S. OUS or mitral tricuspid, but I was wondering 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 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 a market. The vision we had long time ago was about creating a category.

This patient have a very view option 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 a category. And truly, this is the way we are thinking about it. At investor conference, I think we gave you some some vision for 02/1930. We believe our TMTT business could be a €2,000,000,000 business from €300,000,000 of so last year to €500,000,000 or so this year. So clearly, clearly, an amazing trajectory based on all of these. I'm going to ask David to talk more about this year.

Yes. Just to give a couple more details about first add into that. I completely agree with Bernard that for us, we know that there are just millions of patients with tricuspid mitral disease And and we feel like we have an opportunity to help them. And 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 Evoqua will be large growth drivers for TMTT in 2025 versus 2024? And to Bernard's comment just about M3, M3 Would Just Be 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 the overall number of procedures that can help patients. [indiscernible] Thank you. Our last question comes from the line of Joanne Wundt 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 twenty twenty five. Can you remind us what that market up opportunity is and why that's an important product in the portfolio?

Sure. Yes. This is Divina. As well. So just a reminder, C Mark Fremt III expect in mid-twenty twenty five in Europe, with approval in The U. S. In 2026. And the pivotal study the ENCIRCLE study of three hundred patients who were unsuitable for TIER the one year follow-up we expect to release at TCT this fall. And I pressed on unsuitable for TIER, so I think that's really the indication of where we see M3 fitting in in the treatment of patients. We know that TIER is an amazing technology. And there are many patients who get fantastic results. When you talk to physicians and you talk to patients, there are many patients who are suboptimal for TIER. 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 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 Evoqua or like we did with any other therapy, are going to start off by really focusing on physician training.

Having a great team of Edwards Edwards supporting each case, ensuring top notch clinical outcomes and building up a new therapy in a way that this will hopefully become become a new leg to the stool of TMPD growth in the years and the future and provide multiple years of growth to get to, as Bernard said, that $2,000,000,000 of revenue in 02/1930 [indiscernible] 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.

Yes. No, thank you. Maybe some closing comments, really 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 in TAVR, Mitel and Tracker Speed. And beyond 2025, we see an exciting future. We tackle large and 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, Barksen and I. We Thank you, everyone. Have a good afternoon.

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