Boston Scientific Corporation (BSX) Earnings Call Transcript & Summary

Yes. And Travis, one of the key things to realize is we are trying really hard to enable people to use FARAWAVE and Farapulse, however, best fits their needs and their workflow, all right? So for instance, we see in many accounts, particularly in Europe, people don't use any mapping navigation systems at all. But in the U.S., people want to use mapping and navigation systems, right? We are not going to lock you in to say that you have to use RHYTHMIA, right? People are doing these cases today with all 3 of the legacy mapping systems and doing them very successfully. What's coming next though, and so this is the next-generation FARAWAVE catheter that I talked about is putting a magnetic sensor in the tip so we can integrate it directly with the RHYTHMIA system. And there are some advantages we can bring to physicians by doing it. All of the legacy mapping systems out there today, and that includes RHYTHMIA, right were built and designed for thermal ablation for RF, right? And there are some inherent limitations to that when you're looking at pulse-field ablation. And so with this next generation, with the new catheter and magnetic tip and also with some iterations or some innovation with the RHYTHMIA software, they actually built a package that now is designed for and understands pulse-field ablation. And so can do a very nice job beyond just navigating the catheter in space, actually understanding where that pulsed electrical field is going to impact tissue and where you're creating your lesions based actually on the physics of pulsed field ablation.

And so do you expect kind of in the sense of expectations of mapping share that you could get once it's integrated.

Yes. Again, we don't want to force people to use it, but we do think that this new system is going to be compelling, and we do expect, right, that, that is going to take some share, but you just want to come back to what I think is, for us, the really important point that we want people to use Farapulse. We want them to use it in whatever way they are most comfortable with and whatever way gets the best results for patients.

And -- do you have anything, Ally? Anything on FARAPOINT at this point, on how you expect kind of the single shot FARAWAVE and then for PVI and then FARAPOINT for CTI ablations or kind of how you think FARAPOINT is kind of roll out into the market.

Yes. So our initial clinical trial is aimed at getting labeling for FARAPOINT as an adjunct to FARAWAVE for, as you say, CTI ablation, so typical atrial flutter ablation as part of an AF ablation procedure. Post approval, you can imagine that we'd then be looking at ways of getting indication expansion for that. I still don't think anyone once they've used FARAWAVE is going want to go back to the battle days of point-to-point ablation as a de novo AF ablation procedure. So FARAWAVE is still going to be the workhorse for pulmonary vein ablation and for posterior wall ablation where I think -- where we see FARAPOINT used for some of these adjunct use cases.

And then AVANT GUARD is running PFA for frontline therapy, which seems like a bigger opportunity. And maybe talk about that opportunity if PFA can be frontline therapy. And is that a competitive advantage for your therapy versus some of the competitors?

Yes. So first off, I'm glad that you mentioned it, right, that AF ablation, as effective as it is today, is still very poorly penetrated in the United States and the United States is far, far beyond international geographies in terms of the use of the procedure. We have very good reason to believe that the earlier you intervene on in atrial fibrillation, the higher your success rates are going to be, and what we're studying in AVANT GUARD very specifically is using it as first-line therapy, first time a patient gets a diagnosis of persistent atrial fibrillation. And that could, I think, potentially double the addressable market for AF ablation. And the FARAWAVE catheter is really exquisitely designed for this particular purpose. It's a great catheter for pulmonary vein ablation. It is also a great catheter for posterior wall ablation. Trial just began enrolling the end of last year. Pleased with how the enrollment is going, and we see it as a very important trial in our portfolio and for moving the field.

What are you seeing in the overall EP market? Like it feels like the market may be accelerating a little bit? It seems like they're early to be accelerating this quickly, but I know March was a strong month for one of your competitors and EP in general. Just any sense for what kind of the market being at a faster level than it was last year?

Yes. So if you look at the Q1 results across our peers and what we reported, you're right, the market absolutely grew faster than the mid-teens that we had called at Investor Day. And I think there's a couple of factors at play. One, there is an increased level of patient awareness and diagnosis. There's also an element of PFA being at a price premium, which can accelerate the market to a certain extent. But I think the biggest factor is one that can hit on, which is that this is a highly underpenetrated market, where we're bringing a new technology with strong clinical evidence, including efficiency data. And so as Farapulse is launched into these markets, physicians are able to treat more of the 38 million patients with atrial fibrillation.

Great. anything I've missed on PFA before I switch topics.

We could talk all day.

It sounds good. I could, too. Let's go to WATCHMAN and you got the new DRG. You've got the OPTION trial coming maybe later this year. How do you think about that opportunity, especially if you think about the OR efficiencies, it seems like a no-brainer for the hospitals at least.

Yes, I agree with you completely. So right, the CMS proposed inpatient payment rule, now for the first time has established a specific coding for concomitant procedure AF ablation and left atrial appendage closure. Very glad to see it. I think as you say, it's really good for hospitals. Frankly, it's even better for patients. So why undergo the risks and the stress and everything of having 2 procedures when you can have it all done at the same time. This also is an area where I think our portfolio is really well placed to facilitate these concomitant procedures and that starts with our Access Solutions portfolio. That was our Baylis acquisition a couple of years ago, being able to do a safe, efficient transseptal puncture through to Farapulse, where, again, you've got a very safe, but also very efficient procedure. And then with WATCHMAN with WATCHMAN FLX and now WATCHMAN FLX Pro, again, have what is clearly the safest technology for left atrial appendage closure on the market as well as, again, a very efficient procedure. So again, it enables doctors to do these procedures very safely, very quickly on patients again, that's great for hospitals. That's great for docs. As Ally said, right, you increase your lab throughput and maybe make it home in time for dinner. And again, it's most more of these, it's great for patients because, the less time you spend in a cath lab on an operating table, the better you're going to do.

Any expectations for when we see the data or a particular conference you're aiming for? And was there something that kind of led that trial to kind of go faster than you expected?

I'm really glad you asked me that. So the trial enrolled really rapidly during COVID, but we knew that all along. So we have, again, pulled in our anticipated data releasing the data now into late this year or early next year. Honestly, that just reflects a clinical trials team that we have that have just developed some amazing efficiencies in terms of how do you get from the last patient in getting their data through to cleaning up the data, locking the database and analyzing the data. It's what we did with ADVENT. It was one of the things that enabled us to accelerate the ADVENT data presentation and get it in when we got it in last year. Team is taking those same lessons and going to apply them to option.

And then on CHAMPION, just anything that you can point to, to kind of give confidence in that readout, in the CHAMPION trial in 2026 and any thoughts on that opportunity?

Right. So again, just to baseline everyone, remind you, so option is our WATCHMAN trial comparing WATCHMAN to the new novel oral anticoagulants, people after AF ablation. CHAMPION is the direct head-to-head WATCHMAN against the NOACs in all comers. Expect to have the CHAMPION data out first half of 2026. We have a very extensive real-world data experience, both in the U.S. with the SURPASS registry as well as in Europe, we've seen some independent randomized trials out of Europe. And all of it, again, signals that we should expect the stroke reduction with WATCHMAN to be comparable to the stroke reduction that's seen with anticoagulation. And again, just based on first principles, have a very high degree of confidence that we're going to show that we're better off on bleeding than we are with those oral anti-coagulants. Now again, it's research. You never know what you're going to know until you know it. But we feel really well positioned to expect a positive result from that trial.

Great. And on TAVR, a little bit I guess, lack of clarity on TAVR from here for a view in the U.S. I'm just trying to get an update on when we see the data for that. And two, the message on TAVR is like regulatory, we'll think about regulatory strategy, which is different than what you usually say. Usually you're saying, "Hey, we'll submit data at a certain point in time." So kind of what's the reason for that messaging on the TAVR.

Yes, I think -- we had hoped to be able to submit based on an interim analysis. Clearly, we're not. The trial is ongoing. I think not we're speculating on what it's going to show, we're going to know what it shows. I think what we're messaging in terms of regulatory implications, et cetera, is let's see what the data shows, depending on what the data shows, then we're going to be able to establish what is our regulatory strategy in the U.S. I think important to say with all of this, the valve continues to do very well in Europe. The results in Europe are well. In fact, there was just a data presentation at EuroPCR earlier -- last night, U.S. time, early Tuesday Paris time that was independent real-world data analysis, retrospective, but propensity match populations getting SAPIEN 3 versus ACURATE neo2, which showed absolutely comparable outcomes at the end of 1 year in terms of death, stroke, rehospitalization. So we're very pleased with the performance of the valve. We're pleased with commercial use in Europe. And in terms of the U.S., I think it's just not we're speculating until we actually see what the data are.

Just to layer on, in Q1, we saw mid-teens growth in our TAVR business, and we continue to invest in this space. So we talked about bringing Prime to the European market in 2025. And first and foremost, what Prime brings to that market is expanded valve sizing, including an XL size valve, which we think is about 25% of the market we don't play in today. They also had some valve enhancements on the frame and deliverability. So continue to be very pleased with what we're seeing in Europe and internationally.

After the U.S. update, I think one of the questions I got quite a bit was, okay, I can take U.S. out of the model, but what I do to Europe? It sounds like you're confident in Europe, we keep the European numbers in the model and growing like we did before, kind of no impact to the European business.

Based on Q1, the mid-teens growth, we think, was above market.

Okay. Great. And then data HRS on the leadless pacemaker EMPOWER. Curious how you think about that opportunity and how you think about the competitive landscape there?

Yes, really excited about that. So this is data from our modular CRM system. So we have a leadless pacemaker, it's the EMPOWER device. It is the only leadless pacemaker that is designed to be able to communicate with our subcutaneous ICD. And so the data that we're going to present at HRS reflects a prespecified adaptive trial design, so some early cut of those data that show -- that aim to show both that our Empower device can successfully communicate with the S-ICD and deliver antitachycardia pacing for patients so they can still have a "leadless ICD system" but also to show that it can work as a sort of typical stand-alone single-chamber ventricular pacemaker. I think it's important to us for 2 reasons, right? One is it's our first entry into that leadless pacemaker market. People have to wait and see what the data show. But we think that there are some distinct advantages to our delivery system with the device in terms of safety and deliverability, but more importantly, see it really as unlocking and mitigating, right, the big concern people have had in terms of using the S-ICD as a default device for patients with primary prevention indication for sudden death prophylaxis and gives people the ability to either do a staged procedure, start with the S-ICD. And if it turns out you need anti-tachycardia pacing, you can always get it later with this device, again, and stay leadless, or maybe for some patients, you can get both devices at the same time. And so from our standpoint, one of the big implications if the data are positive and the device is approvable will be what it does to unlock further growth with the S-ICD.

We have got 10 seconds on agent DCB, kind of talks to the portfolio that we're doing that last, but. ..

Yes. And gosh, as you said that there are to any things to talk about here. AGENT, the first drug-coated balloon approved for use in the coronaries in the United States approved on the basis of a randomized clinical trial, the data were so strong that it literally got a standing ovation when it was presented at TCT last year. Again, very rapid approval. Approved for instant restenosis, that's about 10% current PCI volume in the United States and then potentially expandable to another 10% of current PCIs when you go beyond that to small vessel disease bifurcation lesions and potentially some cases of acute coronary syndrome.

Great. Thanks a lot. That was a great discussion.

Thanks, Travis. Appreciate it.