Boston Scientific Corporation (BSX) Wells Fargo 2024 Healthcare Conference (Transcript)
Boston Scientific Corporation (NYSE:BSX) Wells Fargo 2024 Healthcare Conference September 4, 2024 8:00 AM ET
Company Participants
Brad Sutton – Chief Medical Officer, AF Solutions
Jon Monson – SVP, IR
Michael F. Mahoney – Chairman and CEO
Conference Call Participants
Lawrence Biegelsen – Wells Fargo Securities
Lawrence Biegelsen
Okay. Good morning and welcome to the 2024 Wells Fargo Healthcare Conference. I’m Larry Biegelsen, the medical device analyst. This our first session at the conference. I’m thrilled to host the management team for Boston Scientific.
With us, of course, we have Mike Mahoney, Chairman and CEO; Brad Sutton, Chief Medical Officer of AF Solutions in case Mike needs to phone a friend; and Jon Monson, Head of Investor Relations. I was telling you, Mike, before the session that Boston Scientific was the Number #1 requested meeting at this conference. I know category leadership is very important to you. So congratulations.
Michael F. Mahoney
Thank you, Larry. Thank you.
Lawrence Biegelsen
You’ve shown category leadership in many different areas.
Michael F. Mahoney
So, so with fantasy teams –.
Lawrence Biegelsen
You’ll be fine, you’ll be fine.
Question-and-Answer Session
Q – Lawrence Biegelsen
Mike, so let’s start with a couple of big picture questions. You took over a company 10 years ago that wasn’t growing, and now you are guiding to 13% to 14% organic growth this year. I know you are not going to update your LRP here, but what gets you excited about the next five years? And asked another way, why should a new investor buy the stock now?
Michael F. Mahoney
Thank you, Larry. It’s a pleasure to be here, by the way. Thanks for letting us kick off. Morning, everyone. I think there is never been a more exciting time at the company. I’ve been here for a little over 12 years. And not only are we excited about 2024, but for the next five years of the company. And there is many different components of that, but I think it starts with just our portfolio choices over many years that we continue to drive, as you said category leadership.
So we have approximately an 8% WAMGR now that we compete in, it used to be 0. And we think that likely continues to enhance, given really the dominant size of the markets of the EP and WATCHMAN and their significant unique growth profile. So we think our WAMGR continues to be very strong. We are executing across the globe. All three regions are growing double-digits. And we have a few businesses that are in markets, call it, 6%, 7% that kind of grow around the 8-ish point, that are our accretive margins, endo, euro, PI. And then we have interventional oncology and all of our cardio businesses which are performing exceptionally well. And we have a strong organic pipeline.
We have a couple of BD deals that are in FTC review. And we have raised that unique VC portfolio. And so we really see this momentum continuing. And I think the one thing that gets lost is just the — because you hear a lot of investor meetings, and talks about products, is just the execution of our team. We have a very deep global bench, something probably difficult to investors to compare in a way. We have a very strong global bench around the world across our business units, our functions. And the team, in general, I think executes better than most of our competitors.
Lawrence Biegelsen
That’s helpful. And Mike, M&A has obviously been a big piece of the transformation, and you recently announced two deals, Axonics and Silk. Should we expect a pause in deals as you digest those?
Michael F. Mahoney
Those are — Axonics take a little bit longer than we thought. But I would say from a balance sheet perspective, we’re certainly very comfortable in continuing our tuck-in M&A strategy even with those two in. What we typically look at besides capacity, which we’re fine with, is more where we integrate those companies. So we have a centralized integration team for ops, quality, IT. It is a long answer. And then we really don’t try to layer on too many per business unit. So we certainly have the capacity and the internal capabilities to continue to do tuck-in deals along with Axonics.
So I guess the answer is, yes, we will continue that.
Lawrence Biegelsen
And Mike, the FTC seems to have gotten tougher. How concerned are you about the increased scrutiny on deals we are seeing in general?
Michael F. Mahoney
I’d say, it is always the screen for us, regulatory pathway, clinical pathway, reimbursements, much higher screen than it used to be and FTC is a higher screen. But all those components have always been a part of our calculus when we look at M&A. But I’d say, in the current environment, it plays a bigger role than it used to.
Lawrence Biegelsen
Got it. That’s fair. And Mike, FARAPULSE has been a home run so far. Do you see other opportunities like that inside or outside of your VC portfolio?
Michael F. Mahoney
Yes. FARAPULSE is unique. I think it absolutely is a home run. I think it will be a home run. It is really transformed one of the biggest markets in MedTech, and you don’t see that very often in MedTech. You see it’s typically more improvements, but you don’t something as disruptive as this, along with WATCHMAN.
So our VC portfolio, across each one of our business units, we have our organic pipeline which more often not, it tends to be a bit more incremental. But it’s been important for the sustainability and make those divisions very vibrant. And many of our larger growth drivers have come from our VC portfolio and M&A.
And our VC portfolio now is larger than it is ever been, and we’ve adjacencies within each division. So we don’t disclose most of our VC portfolio. I think you’ll see us be more active in this portfolio, kind of 18, maybe 12 months from now to the next 36 months. I mean, some of these companies will mature, but we are very bullish on our VC portfolio. And also, it’s also helpful with the FTC because these are typically smaller, maybe no revenue companies, yet that are — have very exciting portfolio pipelines.
Lawrence Biegelsen
Okay. And Mike, you are clearly on track to exceed LRP that you issued just a year ago. Is there a plan to refresh that before the end of the three-year plan?
Michael F. Mahoney
We are not going to update it this year. We certainly are doing nicely against what we talked about at the Investor Day ’23. So we’ll likely have another Investor Day, I don’t think we’ve announced yet, Ally, in ’25. Our usual cadence every other year, and it’s usually in the fall after your meeting. And so we’ll likely do something there in 2025 in terms of an updated LRP.
Lawrence Biegelsen
All right. Fair enough. So let us turn to the 2024 outlook. You posted 14% organic growth in the first half of this year. The guidance calls for pretty similar growth in the second half, 13-ish percent. How are you thinking about how the rest of the year plays out?
Michael F. Mahoney
We are very comfortable with the guidance that we laid out. As I said, really the formula is what I mentioned before. Our MedSurg businesses and PI are kind of upper single digit, and cardiology is delivering very strong growth in a number of areas. Our interventional corner — ICTx business. The imaging portfolio is doing extremely well as imaging becomes more popular in the US, as it should be, based on clinical data. AGENT is starting to build some momentum. We’ve got important reimbursement decisions upcoming in the fall here.
You know the FARAPULSE story. We grew 125% in the second quarter, and we are just getting started still in the US. And I was just back from Asia over the weekend here in China, and we’re super excited about China and Japan primarily in 2025. WATCHMAN is doing very well.
In CRM, we are excited about the launch next year with our S-ICD and our leadless, for that to pick up a bit more. So we feel very comfortable about our guidance for the full year.
Lawrence Biegelsen
Sounds good. And we were encouraged to see like, call it, 40% to 50% of the upside in Q2 on revenue drop to the bottom-line. Are you thinking about balancing, reinvesting, versus letting the upside fall to the bottom-line going forward?
Jon Monson
I can jump in on this one. Thanks, Larry. So first, we are pleased with the operating margin performance in the second quarter 27.2%; and the raise to our guidance the 50 to 70 basis points of operating margin expansion here in 2024.
To your question, we don’t necessarily see it as all one-off or all the other, I’ll reinvest or drop it all through. First and foremost, fully committed to the operating margin goals for ’24 and over the LRP that we laid out. Then to the extent that we have upside, we would look for opportunities inside of BSC, reinvest that to drive that top of the class revenue growth that we are seeing on into the future, and then we may let some drop through thereafter.
So more of a balancing act. So I think that is what you have seen here in 2024, a nice balance between reinvestment for the future, but then strong drop-through on the incremental revenue that we –.
Lawrence Biegelsen
That’s helpful. Mike, before we dive into PFA and FARAPULSE, just one other high level question. Any early high level thoughts on 2025? Any puts and takes we need to consider?
Michael F. Mahoney
2025, well, obviously we are going to wait, just like we normally do to give guidance after — during our fourth quarter earnings call, which would be, I guess late January, February. Well, we are excited about the year. We’re still — kind of put the — I hate to clump endo, uro, PI together because they are tremendous businesses. And if they were stand-alone businesses, they would be higher than the peer-group in terms of sales growth and OI.
But we expect consistency there. We expect to close Silk Road and Axonics in the second half of this year. So those will be not organic, but we will integrate those companies in 2025, which will be exciting for the future for those divisions. And we expect big things out of the cardiology group and Interventional Oncology, I would say. We are really still in the very early phases of our US launch. We absolutely believe that we have the best FARAPULSE PFA product in the market because we see the competition in Europe. So we’ll have a full year benefit of that, and we’ll be launching in Asia Pac.
And we’ll have some important — I’m sure you’ll ask Dr. Sutton about — I’m cueing you up, About OPTION. So we expect good things out of WATCHMAN. So we expect — we will certainly have some more difficult comps, but we had a tougher comp in 2023 for this year as well. So we expect to have a very strong year. Really, our goal is to consistently — we’ve kind of modified over the years of being at peer group, above peer group.
Our goal is to be the highest-performing MedTech company. And we think we were that last year, we think we’ll be it again this year. And that’s our goal, to be consistently the preferred highest performing MedTech company.
Lawrence Biegelsen
That’s helpful. All right. So PFA and FARAPULSE, it took about 10 minutes to get there.
Michael F. Mahoney
Nice job.
Lawrence Biegelsen
Mike, I was intrigued by your comments on the Q2 call. I think you said EP could be the biggest business at Boston Scientific at some point. I think we modeled out $1.6 billion in 2024 which is up from I think about $1 billion in ’23. And so looking at your businesses, you have Interventional Cardiology, endoscopy, both are about $2.6 billion today and growing nicely. So when you said it could be the biggest business at Boston Scientific, I guess, over what time frame?
Michael F. Mahoney
Yes. We won’t get specific there, but just the business is growing extremely well. And Interventional Cardiology has grown near double-digits and Endo is typically upper single digits. So excellent divisions there that we continue to invest in. EP, I won’t give you a date, but it just has the potential. Because the market is growing plus 20%. The market’s — the growth has accelerated due to PFA because doctors are doing more procedures and now you are globalizing that. So we believe that the two strongest markets in MedTech, we are the ones leading the disruption in, that is EP and LAC. And both of those markets have the chance to have the greatest TAM expansion in MedTech.
We think the EP TAM expansion with persistent and other trials that we are running, they are growing at the 20%, maybe the best market. And we think WATCHMAN has the market of about $1.5 billion today, that could grow to $6 billion in 2030. We think the two biggest markets you could get into right now for a MedTech company are EP and LAC, and we have really strong position, especially with concomitant. So in EP, I won’t give you a date, but it certainly has the upside potential to be in the race and potentially pass those divisions.
Lawrence Biegelsen
That’s helpful. And you indicated that PFA adoption is exceeding the expectations, you are exceeding your expectations and you now expect to be at the high end of the Investor Day outlook of, I think 40% to 60% penetration worldwide by 2026. What’s driving that? And what are you seeing in major geographies?
Michael F. Mahoney
Turn it over to you –.
Brad Sutton
Well, I still think that’s conservative. I actually am more bullish than that. I mean, there is a couple of things that sort of work together to tell that success story. First and foremost is the FARAPULSE transformational technology, right? It’s safer and it’s really easy to use. And you’ve got now — if you look back at physician reimbursement which has taken a number of haircuts over the last couple of years, there is this mentality in doctors’ minds to have to do more with less. And so here, you’ve given them a tool that’s safe where they can do 30% to 50% more in a given amount of time. And all of that sort of comes together to tell this really amazing growth story.
So you’ve got EP labs doing more throughput, waiting list going down. It is a very compelling confluence of things that have led to that growth story. I think the 60% PFA penetration in AF ablation is, in my opinion a gross underestimate.
Lawrence Biegelsen
What about the geographies? What about US, Europe? Maybe talk about China and Japan, your expectations.
Brad Sutton
We had really this interesting sort of lab that was the EU launch right, a couple of years ahead of U.S. launch. And what we saw was, where we thought a lot of the sort of cryo single shot would give way to PFA, actually was the point-by-point RF, which historically are folks that are slow to adopt new technology. And frankly, in many of those centers, it’s 90% of the AF ablation. I’ve had folks in Europe tell me they haven’t done a de novo RF ablation in two years. So I think that is playing out very, very similarly in the US. We’ve just got China approval. We are on path to get Japan approval. I don’t expect it to be any different in those geographies.
Lawrence Biegelsen
In China, you have approval. You were just there, Mike. That’s a $1 billion market. Japan, you said second half of — reimbursement, also second half for Japan. That is also a $1 billion market. So second half approval and reimbursement, because obviously, in Japan, it is important to have reimbursement right at the launch.
Michael F. Mahoney
Yes, the competitors will get reimbursement indication in advance of us in Japan. But I would say, in the market, we expect Japan to look a lot like EU and US. Very mature market, a lot of sophistication there. And we also have a stronger presence. We think the China market is — the market TAM is maybe even larger over time. But that may play out a little bit slower than Japan because of the listings that are required, again, on the preferential tenders and certain listings by geography. And we also have to build out a bigger team there. So we are very bullish on both. I wouldn’t be surprised to see if Japan takes off a bit faster than China.
Lawrence Biegelsen
And I mean, back to the durability question. I know — I think I asked it on the Q2 call. Mike, how are you thinking about just the durability of the growth, your share, your competitive position in EP? For Mike or Dr. Sutton.
Brad Sutton
Well, my world is largely WATCHMAN and EP. And in the WATCHMAN world, what we’ve done is we continue to disrupt ourselves with sort of internal innovation. And we are running that play — franchise now. I think it comes down to the right people being aggressive and visionary. And when I think about kind of our internal R&D pipeline in EP, it is a really good story. So I think we continue to capitalize on our PFA leadership.
Lawrence Biegelsen
Where are we on mapping integration? Is that still a second half 2024 approval in the US?
Brad Sutton
So we have a 510(k) approval now for the software, and we are awaiting approval imminently for the nav-enabled catheter.
Michael F. Mahoney
Yes. I think in the EP world, we know there is good competitors out there. And we traditionally had not been the leader in, but we expect to be — our aim is to be the leader. But as Dr. Sutton said, we have a very strong organic pipeline, we also have a number of VC bets, and we are also leading the industry in clinical data and pushing the clinical capabilities.
We are also aware of the competitors. You can’t sneak up on anybody in MedTech. We know, understand what the competitive pipelines look like. We compete with them very successfully today in Europe. And so we expect to continue to do that. We know it will get tougher, but our product portfolio will continue to enhance and the market will continue to grow, and we think concomitant will be a big differentiator for our company.
And maybe in the future, you potentially might see this move to more of a potentially an ASC setting. And we think FARAPULSE is uniquely suitable for that setting versus our peer group, given the less of a requirement for general anesthesia and potentially less of a requirement for mapping.
Lawrence Biegelsen
Your two largest competitors, obviously J&J and Abbott, they have very large installed bases on mapping. How do you neutralize — eventually, they both have catheters, right, around the world. How do you neutralize that benefit that they have?
Brad Sutton
Yes. I mean, I think we have a healthy respect for what the competitor competitive companies have done in their footprint. We’ve been very aggressive in hiring field force to sort of catch up, if you will. What I can tell you is that, as we look forward to our mapping integration, it is an evolution of what we’ve done historically. So we are moving from sort of this very complex suite of tools to a relatively simple reproducible workflow. That is very, very compelling.
So back half of this year, you’ll see full integration with our mapping system, navigation and mapping system, redefining the way we tag these lesions in a way that the competition has not shown that they are able to do. And it’s simpler and I think it’s intuitive. And so we’re hopeful that the combination of an augmented field force and a relatively straightforward tool is compelling to folks to keep using FARAPULSE.
Lawrence Biegelsen
Got it. Mike, I mean, you were distant, I think, Number #4 before FARAPULSE, right, in the EP space. Your shares, whatever mid-teens at this point, somewhere depending whether you include Baylis or not. My question is, do you see a path to becoming Number #2 in this market?
Michael F. Mahoney
Yes. Yes, we’re Number #3 now and we do see a path to Number #2, and we strive over the long term to lead the market. That is an ambitious goal because there’s a very tough competition there. But it’s — as I said, it is the biggest market and it’s unique for a company to transform it.
There is other elements that we’re actually — in one way, we need to round out the portfolio more. Because as we do more procedures, others are benefiting from more mapping, more catheters, more ICE catheters. So we need to round out that piece of the portfolio more in the next 18 months to also enjoy the benefits of what FARAPULSE catheter brings.
So you will see us do that over the LRP. And it is always good to have ambitious goals, but we just want to continue to execute every day. And that’s what’s making FARAPULSE of the company special, is just constantly trying to raise the bar internally, having strong talent, succession planning and executing every quarter. And if you kind of break up the game that way, eventually, you can make strides to potentially become Number #2 or potentially Number #1 over long term.
Lawrence Biegelsen
Where — besides the installed base for mapping, where are the product gaps right now in the portfolio? You sort of talked about, Mike, rounding out the portfolio, I think.
Michael F. Mahoney
Go ahead.
Brad Sutton
I think the mapping integration is first and foremost. We talked about pull-through from competitive batches that are used to map our ablation cases. That, we hope largely goes away once we’ve got full integration and start mapping. That’s kind of the first piece. And then I think there another — a number of other catheter form factors and kind of ablation use cases outside of atrial fibrillation, pulmonary isolation, where we’ve got I think really good strategic bets. And you can look forward to seeing us do additional work in the ventricle. But I think a really compelling single-catheter map and ablate workflow. So those are things that come to mind.
Lawrence Biegelsen
Got it. One more question before WATCHMAN. So Affera, their pivotal data looked good to us. You’re going to show the ADVANTAGE trial for persistent AF. That’s where Affera did their pivotal trial. I think late 2024, I believe, you’ve said at American Heart, November. What are your expectations relative to Affera? And maybe Dr. Sutton also addressed the fact that they’re able to do PFA and RF, which could be more efficient for some labs.
Brad Sutton
Yes. I mean, I’m not sure it is more efficient. Actually, we’re — be interested as we stack up our procedure times versus theirs. So I would bet that we’re significantly more efficient with persistent application. But I think we do hope to have that data on podium back half this year. It is a rigorous study. So it’s a single-arm trial with prescribed PVI posterior wall ablation workflow and rigorous endpoints in terms of monitoring for arrhythmia recurrence.
And I think it will be competitive against any persistent data AF that’s out there. I would caution that, when you are comparing studies, they are not — the endpoints are defined differently, the monitoring strategy can be different. So they are not always apples-to-apples comparisons. But when you look at the compelling workflow and the efficacy that we’ve seen historically, I’m excited to put that data on podium out. It is a good story.
Lawrence Biegelsen
Okay. That’s helpful. Maybe staying on the American Heart theme, but transitioning to WATCHMAN. I think you’ve also talked about OPTION being presented later this year. Is that the goal still, to present at American Heart? I know the late-breakers, I don’t think they’ve been posted yet. But is that still the goal?
Brad Sutton
Yes, that’s our hope. We haven’t heard back from them. But that is, I think, a seminal piece of data. Remember, that’s our first randomized data versus NOAC in that space. It’s been a long time coming. It was a three-year trial. And we’re excited to show it. Remember the endpoints in that were non-inferiority for efficacy for stroke, systemic embolism, and all-cause mortality, and superiority on bleeding endpoint as well. So we’ll see what that data looks like later this year.
I would remind you, too, that in the group of folks that were implanted, the randomized long-term OAC versus WATCHMAN after an ablation, 40% of those were done concomitantly. So while the concomitant story isn’t the sort of seminal story on podium at AHA, we will present probably early portion of 2025 with that concomitant subgroup looks like.
Lawrence Biegelsen
So in other words, at AHA, we’ll see the full cohort.
Brad Sutton
Correct.
Lawrence Biegelsen
And then earlier in the year, we’ll see the — 2025, we’ll see the 40% concomitant?
Brad Sutton
That’s what we anticipate, yes. And the sort of relevant outcomes with concomitant versus [indiscernible].
Lawrence Biegelsen
My question is on OPTION. What are the implications of the OPTION trial? And I think there are probably many I can think of, okay? And this morning, one theme I’ve heard clearly is this concomitant use with LAC, LAAC and FARAPULSE, that seems to be a big part of the strategy for Boston Scientific, something differentiated for you guys. But what are the implications in your view, Dr. Sutton, on OPTION if the trial is positive?
Brad Sutton
I mean, several things come to mind. First of all, as an EP, when patients come to your office for an ablation, they expect to be able to come off anticoagulation after that ablation. That is not the case today. It isn’t what the guidelines suggest. And so now it is an option to come off blood thinner, hopefully with the knowledge that you know you are protected against stroke at least as good as you would be within anticoagulant. So I think there is this tremendous patient benefit.
The other piece as the concomitant story plays out, and you know we have this concomitant DRG that goes live in October, which is a tremendous story, I think. Is you now have the ability to, with call it, an extra 10 or 15 minutes of procedure time, implant a device, take care of both procedures. That is one exposure to anesthesia for the patient. That’s one exposure to vascular access and the risk of bleeding complications. It is a great patient story and it is a very efficient workflow for the physician. And now the hospital, by way of this new DRG, is made whole financially.
Lawrence Biegelsen
And the fact that it’s an inpatient code, we shouldn’t overthink it, given these are primarily outpatient procedures. Does that make any difference at all that it is an inpatient code?
Brad Sutton
In the near term, I don’t think it does. I wouldn’t overthink that. That story will change over time. WATCHMAN, of course has been on the inpatient-only list for many, many years. That will probably change at some point, but I think TBD on the timing there.
Jon Monson
I think a tremendous opportunity for patients who treated. 500,000 patients to-date with WATCHMAN. And then fits right into the growth that Mike laid out earlier that we see for that LAC market, 20%-plus between now and 2030.
Lawrence Biegelsen
Does OPTION sustain the kind of current growth, or could OPTION kind of accelerate the growth?
Michael F. Mahoney
Yes. I would say it is smart for us to say the base is getting larger and larger. And so I think, it helps sustain kind of that 20% average market growth rate that we’ve been seeing. It would be interesting, too because I think CHAMPION potentially could disrupt it more.
Lawrence Biegelsen
Oh, there’s no question.
Michael F. Mahoney
But I would say, until CHAMPION’s read out, a market CAGR of upper teens, 20% given the base is increasing is very comfortable. And CHAMPION, as I said between OPTION and CHAMPION, thanks to Dr. Sutton and Ken Stein for doing all this work, take a market from $1.5 billion to $6 billion over 2023. So that market CAGR either could sustain even though the base is bigger or get potentially more upside with CHAMPION.
Lawrence Biegelsen
The other implication from OPTION, Dr. Sutton, that you did — you might have alluded to earlier, is you said it is the first kind of randomized controlled trial versus NOAC. So how good of a read-through is OPTION to CHAMPION? And can you confirm that we’re still going to see the CHAMPION data the first half of 2026, is which what I think you said before?
Brad Sutton
Yes, I think actually, it is a very good readout for CHAMPION. Time will tell. But if you think about it, the average implanted patients with the WATCHMAN device is actually quite sick historically, typically a history of bleeding and what have you. Whereas ablation patients must be able to tolerate long-term anticoagulation. They are a lower-risk patient population on average, and I think we’ve got a good snapshot of that on OPTION.
As CHAMPION played out, turns out it is a much more kind of all-comers patient population with atrial fibrillation, and far lower risk than the typical WATCHMAN-implanted patients. So in terms of risk profile, I think they are actually to be quite similar into that, and I think the stroke rates and the outcomes you see will be quite similar.
Lawrence Biegelsen
Okay. That’s super helpful. 7.5 minutes left to talk about the rest of Boston Scientific, Mike. Anything on WATCHMAN or FARAPULSE, in all seriousness, that we didn’t cover? Dr. Sutton, anything you wanted to mention?
Brad Sutton
No, I think very thorough.
Michael F. Mahoney
Only thing I’ll just emphasize is efficiency in the lab is becoming more and more important in my tenure at Boston Scientific here. And that is where WATCHMAN and FARAPULSE really hit that sweet spot. You see other structural heart procedures which aren’t as efficient and actually more cumbersome and more expensive. And so I think, along with the safety and efficacy, WATCHMAN and FARAPULSE, concomitant potentially AFC, hit all the clinical and safety endpoints, but also a real benefit economically for hospitals with efficiency and reimbursement.
Lawrence Biegelsen
Got it. That’s helpful. All right. AGENT, you talked about AGENT starting to take off earlier.
Michael F. Mahoney
I wouldn’t say take-off. I think it’s doing really well. It is very early. It’s important for us. We have a number of sites on contract now. We have some important swing factors based on the reimbursement which we would expect to hear –.
Jon Monson
Start of 2025 for TPT and then October 2025 for NTAP.
Lawrence Biegelsen
Okay. But so far, so you’d characterize –.
Michael F. Mahoney
I would say it’s a terrific device because we’ve seen it work that capture a significant share in Japan and Europe. We think it will have the same benefit in the US. But the reimbursement will help decide whether it is a really significant growth driver or a smaller growth driver.
Lawrence Biegelsen
Got it. So TPT would be outpatient, January ’25. 50-50 in terms of outpatient versus inpatient, ballpark in terms of procedures?
Jon Monson
That’s how PCI split. We’ll see how it plays out.
Lawrence Biegelsen
About 50-50, right?
Jon Monson
Yes.
Lawrence Biegelsen
I got it. But this is in-stent restenosis, so may be more inpatient. I don’t know if that’s the case.
Michael F. Mahoney
Depends who you talk to, but close.
Lawrence Biegelsen
Got it. Okay. And neo2 has been topical, ACURATE neo2, your TAVR business. Mike, the question — first question is, when are you planning to file for US approval? Because we know that the trial ended, I think you said publicly, it ended in June 2024.
Michael F. Mahoney
Yes, yes. So it is the same comment from our earnings call. It’s a 1,500-patient trail. It is the largest randomized trial done in the TAVI space. And we expect first half ’25, would be AHA –.
Jon Monson
Yes, targeting ACC.
Michael F. Mahoney
ACC 2025 is the target date. But yes, I would say what we’re — so that’s the regulatory process. But we’re coming off — we continue to build more and more momentum in Europe. And we continue to outgrow the market pretty consistently, not by a huge amount, but outgrowing the market. And this new Prime Valve that just received approval in Europe we think it will be a big adder to it with the larger size, a little bit more radial force and even making the valve easier to use with even less pacemaker rate.
So we continue to evolve the platform with a very competitive COGS and nice gross margin, and we’ll invest more in Europe. So we really excited to see that, the current progress in Europe and the Prime launch, and Prime is what we aim to launch in the US.
Lawrence Biegelsen
But the ACC is the presentation timing. My question is, when do you think you’ll be able to file in the US for neo2?
Michael F. Mahoney
I don’t know. I’m not sure what the filing date is, but ACC is when we expect to read out the data.
Lawrence Biegelsen
And just one follow-up question. It is a relatively long period of time to wait, right? ACC, I think I looked at, it was late March, early April. Trial finished in June. Why wait so long to present the data?
Michael F. Mahoney
We are going to end it as soon as we think it makes the most sense. It’s a complex trial, there is a lot of data follow-up with it. And we are very bullish on the portfolio, we’re very bullish on the product. We expect to have a successful launch in the US.
Lawrence Biegelsen
And Mike, I know from the LOTUS experience, you are probably going to be a little bit cautious in terms of giving any kind of projections. But what are your aspirations for neo2 if the trial is positive? In Europe, you have about 8% share –.
Michael F. Mahoney
Yes, assuming it goes well, it will be a nice growth driver for us. It won’t be as big as some of the products that we talked about, but it’s a nice market. It doesn’t grow as fast as it used to, but it’s still an upper single-digit growth market. And we would certainly be a share taker there. We wouldn’t aim to be Number #1 or Number 2 overnight, but it would be a nice growth driver for us.
Lawrence Biegelsen
I mean, is 8-ish of share about right, for Europe ballpark? Is that kind of where you are today?
Jon Monson
So we are about 20% share in the accounts that we’ve launched in. We just launched Prime in Europe that has the large size now. That will open up a portion of the market that we haven’t participated in to-date. It is about 25% of the market there. So excited to get that rolling in Europe. And we’ve continuously taken share in Europe with the ACURATE neo2 platform.
Michael F. Mahoney
8% is probably generally — 8% to 10% is probably close enough.
Lawrence Biegelsen
So Mike, I have 2 minutes — 2.5 minutes left and I’ve got a long list of additional questions. What are some of the other areas you’re excited about? I mean you’ve got, obviously, peripheral is doing well. You just — have the EMPOWER modular leadless pacemaker data recently. Relievant looks like a nice acquisition for you. What are some of the other areas you would like to highlight in the last few minutes here?
Michael F. Mahoney
Well, we talked a lot about the growth side of the business. And if you look at the next five years, as I talked about with those WAMGRs enhancing in those big categories where we have unique differentiation, and our capacity to do appropriate M&A and a very robust VC portfolio, we feel comfortable with the growth story.
I think in parallel with that, which didn’t get much airtime today, is our ability to continue to deliver OI margin improvement. We are nicely above where we were pre-COVID levels, which most companies are not — and with 50 to 70 bps margin improvement goal for the year in 2024. And we’re appropriately managing our growth investments and clinical investments to continue to be at the very high end of our peer group in sales, but also to continue to deliver consistent margin improvement. So I think that’s a nice, balanced structure for the company, and we are continuing to do that this year and over coming years.
Lawrence Biegelsen
That makes sense. And Relievant, so far, so good?
Michael F. Mahoney
Yes. Yes. Goes organic probably in the fourth quarter.
Jon Monson
It goes organic in the fourth quarter. Seeing very nice growth and nice performance since the acquisition. So drive accretive growth for neuromodulation.
Lawrence Biegelsen
And maybe lastly, Mike, you’ve got some early bets in some other big areas like IVL, percutaneous coronary pump space, right? Two areas where J&J just spent $15 billion, $16 billion, right to get into. Any commentary on the progress you’re making with your programs?
Michael F. Mahoney
We’re not going to spend that much. But I would say, we have a lot of programs. We have three PFA VC investments outside of EP, which are very exciting, across the company. We have a number of — in heart failure, we have most of — maybe 70% of them are in our cardiovascular area. And that’s certainly two big markets that we like a lot that we have capabilities in. So those are all — those are two amongst the many other markets that we like.
Lawrence Biegelsen
Okay. Perfect. Well, we’re out of time. Really appreciate you being here. Thanks for the discussion.
Michael F. Mahoney
Thank you.
Jon Monson
Thanks, Larry.
