LivaNova PLC (LIVN) Earnings Call Transcript & Summary

All right. Good morning, everyone. Hope you can hear me okay. I'm Amit Hazan. I'm a medical technology analyst here at Goldman Sachs, and I'm getting ready to kick off Day 3 for the med-tech conversations at least. And we're really excited to have back with us at this conference, LivaNova, and we've got the whole crew here with us. First, before I introduce them, Phil Coover, one of my partners on the med-tech team is here too to ask questions. And so we've got CEO, Damien McDonald; CFO Alex Shvartsburg; and Senior Vice President and Corporate Development Matt Dodds. I bet you can recognize who is who here, without me asking. So guys thank you so much for being here today, and we're excited to get the updates from you. As you might imagine, at this conference so far this week, we've always -- we've been starting the conversations with the macro stuff.

That's still top of mind for a lot of investors. So we'll ask a couple of questions there just to get that out of the way and then we'll get to all the good stuff that's going on fundamentally. But I don't know, is there much you can tell us about where we are with hospital admissions and just volumes generally and what we've seen in the recovery since Omicron wave kind of subsided?

Yes, sure first of all, Amit, thanks for having us along. 2017 was the last time we were here. So thrilled to be back and thanks for you guys coming along to listen. Look, I would say, like our commentary in the quarter, Jan/Feb weren't great and lots of noise in the market. Then March started to improve, and that continued through April. May was pretty solid. I would say June has been messy. And it's got a lot to do with COVID and staff shortages, and yes, depending on which business unit you're talking about, that June has been more challenging than we anticipated. But right up through May, it was pretty solid.

Okay. Yes, and I mean listen we're hearing it all over the place at this conference. So it's probably at this -- by the third day, not as surprising. But what do you think it is? I mean, is it -- are you attributing that mostly to hospital staffing and shortages or are there other issues that are specific to your business? Maybe just talk us through just qualitatively what's going on?

Yes, I think -- well, I think it depends on the business. So for epilepsy for new patients, you have to have the patient and their carer come in. So we were talking this morning, Brianna said, well, everyone's got COVID. In that environment, a patient and their care are just sort of more reluctant to come into a hospital. So we've got sort of how do you fill the pipeline of new patient implants? You've got to have the people come in or be willing to come into the hospital. So if that's not happening, that starts the funnel problem. Then you've got to have the work up. And for that, you need the EMUs open. Well, the EMUs are open, but they're only at sort of 60% capacity because they're not staffed. And then if you get a patient through that part of the funnel, then you need to schedule them for surgery. And if you're a neurosurgeon, it's more sexy to do a spine or something else than a 45-minute VNS. So -- and they make more money. So I think there's a preponderance of just doing the end of service patients because you have to do them to keep them in therapy. So the new patient funnel has been challenging. In ACS, and we talked about this in the quarter, that's challenged by the fact that you just don't have staff in the hospital, or if you do, you don't know if they're going to be there tomorrow. And for ECMO, it's pretty labor-intensive. And so if you're going to start a course of ECMO, you want to know that people are going to be there, not just day 1, but day 15. And I think that's putting people in a position where they're reluctant to start ECMO cases. Cardiac on the other hand and 65% of our business is outside the U.S., but cardiac seems to have bounced -- the cardiac procedures are back to sort of pre-COVID levels. I don't think I missed.

No, I think that summed up perfectly. Again, a lot of the earlier comments was U.S. with the staffing, all that. I think internationally, things are a little more positive.

Yes, I think internationally, they've been dealing with staffing shortages forever. So it's just continuing. They kind of just absorbed that and factor that into their schedules. Okay. So I'm sure we'll get into a couple of other things a little bit later. With that quickly on supply chain too, just because it's come up, you've mentioned microelectronics and epoxy availability, transportation, logistic challenges, increasing inventory in several areas. Just give us an update, if you can, on the progress with those topics?

Do you want to take that?

Yes, I mean it's -- like what you've heard from everybody this week, it's just continued -- and we expect it to continue through the rest of the year. Started with sort of supply constraints driven by logistics challenges and that's continued and has a knock-on effect on freight and transportation costs. We have -- in our CP business and the HLM business we have a very sophisticated device, the bill of material calls for 1,700 parts. Any one of those could be challenged at any point in time. Our team has done a pretty good job of sourcing, looking for alternative sourcing and dealing with the challenges that we have. So I'd say it's all factored into our guidance. That's -- we anticipated that earlier this year, nothing has changed.

And it hasn't gotten better.

And it hasn't gotten markedly worse which is kind of helping me sleep at night.

I mean that's a positive. So last one, China and Russia, just remind us maybe of exposure and if that -- if there's any update to your...

In Russia, it's 1% of our business last year, so not a significant exposure. We've -- it's challenging to do business there, because we now have to do all kinds of checks against Western sanctions and making sure that we're not selling into military hospitals, what have you. But so -- but it's not a significant portion of our revenue base. So it's -- that's factored in. China is roughly 4% of our revenue base. And most of it is CP. That business just continues to perform well. Neuromod is -- it's underpenetrated in China. So it hasn't had a huge impact there.

Okay. Okay. So let me ask a couple of quick recaps on the guidance for the year, and then we'll go straight into the business lines and pipeline. Maybe first, just if you think about your EPS guide, the first quarter call kind of from the initial 4Q call guidance. And the top line organic guidance unchanged 3% to 5%. FX supply chain worsened, some of the stuff we're just talking about. What were the positive offsets that led to the reiteration for the year?

It's really our tax rate. I mean if you look at it, we've guided to, what 10% to 15%. Q1 was at 7%. So that's sort of offset the negative FX and any inflationary issues.

Okay. Okay. Simple enough. And then the 3% or 5% -- and maybe a little color to what gets you closer to 3%, what gets you closer to 5%?

Well, yes, the -- what gets closer to 5% is the epilepsy market opens up, and we've predicted the back half of the year is a bit better than the front half. So that's one. The cardiopulmonary procedures continue to expand like they are, so that the oxys keep growing. HLM sales are solid. We've been very conservative in our forecast ahead of the Essenz launch in the second half of the year. But if capital sales in HLMs continue to go the way they have, that gives us more upside. And then if we find ways around counter-measuring the Russia-Ukraine. And so far, the international team has done a good job of that, if that continues to run like that. And then I think if FX abates, those sort of 5 things gets us to the top end of the range. Corollary is any one of those go peer shaped, it puts pressure towards the 3.

Okay. Okay. And your epilepsy guidance inside was unchanged.

Yes.

Is there anything to think about there? We talked about some of the macro stuff going on. But in terms of like how you thought about the year leaving yourselves room for uncertainties going on in the world?

Yes, well, like I said, we predicted and forecast it gradually improving throughout the year. And as Matt said, part of our business is international. We're about 20% is international, and that's continued to perform really solidly. So that's also helping us lift the overall performance of the epilepsy business.

Okay.

Yes, just one more before we leave it on the ACS side, a pretty sizable downward revision and after just 1 quarter. Just try and kind of level set for us what gives you confidence that that's kind of the right rebasing in light of the environment?

You want to...

Yes, so I think what we said in Q1 and into April was that the market has dislocated. It wasn't just our business, the overall ECMO performance. So everybody that does ECMO in the U.S. have seen this decline since November actually. And our thought was that over time, you're going to see a move away from the COVID procedures back into the cardiac procedures. And we still think that will happen. But as Damien said, some of the staffing is really an issue not just in respiratory of the cardiac because patients in cardiac on therapy multiple days as well, not just respiratory. So you have to make sure you have the staffing that we think that will improve over the year. But on top of that, we also think that some of the machines that were moved into the respiratory side to deal with COVID because most hospitals have 2 to 4 machines that are doing ECMO procedures are going back to cardiac and they're going to now be able to use the machines for a while, the machines are being basically captured by the respiratory side in the ICU. So that's what gives us the confidence. Plus on top of that, we did add salespeople last year toward the end of the year. It takes them about 9 months to really get up and running. So we're going to see them hit in the back half of the year as well in terms of adding revenue to the overall business.

Yes. Okay. I think that's good there. We're going to kind of change gears a little bit and go back to fundamentals of the business now. On the epilepsy side, we've already touched on it a little bit, some of the dislocation that's happening in the month. We talk about backlog in a couple of different ways. First, on kind of the end of service where you've given some pretty good clarity. Tell us about the size of the backlog that you guys think exists right now from the disruption that's happened over the last couple of years and then the pacing to kind of work through that backlog in your view?

Yes, it's probably around 700 units or patients that we're still carrying, and we seem to be burning them about 100 a month. And so we've got probably through this year and into the start of next year with that end of service backlog.

Okay. So another kind of 3 to 4 quarters to basically work through it about 100 a quarter?

Yes.

Okay. All right, that's helpful. I think on the new patient side, it also feels like there's a bit of under treatment that's going on. So how do you think about backlog for the new patient side?

Yes, I don't think we've ever really talked about it being as a backlog as more of a delay. What we're seeing we believe is patients just get pushed out. So the patient pool is still there. And we just need some of the dynamics that I talked about earlier to start unfolding so that we are starting to put patients back in at the top end of the funnel. And that's the lag at the moment. Our new patient funnel is just lighter than normal.

Okay. Okay. So we need some lifting from a COVID perspective, and thanks to get back to...

Yes.

What are signs that you're looking for outside of the COVID disruption that would give you confidence in kind of the funnel opening back?

Well, we have -- we call it picks and ops. So basically the opportunities and it's the leading indicator for us for what happens 55 days later and when we see that start to turn. And by the way, we did see it start to turn in sort of April, May. June was softer than the normal. So that for us is the leading...

Indicator.

Yes. That for us is our leading indicator of what's going to go.

Okay. All right, that's helpful. I think as we kind of look forward, it would be helpful to hear more about the CEC strategy and how the team is developing and sort of your perspective on how that's gone so far and prospects going forward?

Yes, I'm actually really encouraged by this. It's a pretty big pivot because we were essentially selling widgets. We put a widget in the hospital that implant it we've put another widget in the hospital. And we never really consciously thought about how to approach the CECs where these large patient pools work. Now 50% of our business came from CECs, but it was, as I said, as a 1, 2 unit sale, not thinking about how a patient moves through that process. So surrounding the CECs with the support team, which by the way, in other med-tech basis has been done before. CRM has done it, spine has done it. This was really giving a key account manager the responsibility to grow 4 to 5 CECs in a defined geographic area. So we weren't burning windshield time. We weren't being inefficient with rep-facing activities. We put in a clinical nurse educator. These people were RNs with an education background that took away the resource of the rep having to follow the patient a much lower-cost person, but with a skill set at canceling patients. And then we put in MSLs, which are medical science liaisons who could work through the science of VNS both clinically and from a patient point of view. So that surround sound is really how we're focusing those things. There's around 260 CECs. We're now in about 35%, 40% of them with our pods. And those pods are starting to read through in terms of their effectiveness then at the results through Q1 were really solid. They were sort of almost 5x the baseline business. And so we're quietly encouraged that this is the right strategy, again, notwithstanding all of the headwinds we just talked about. And that we're breaking through. There are clinics one in the Midwest, where we had almost no access, almost no business where we now have built quite a sizable recurring business there. And that, for us, is the indicator. Now we're not going to ever get to 100% coverage because there's, just diminishing returns. But we've still got room to grow with those pods for another year or 2 at the rate we're putting them on. We're putting on 1 or 2 a quarter.

Okay. That's really helpful. Pivoting just a bit here to the CP business we already touched on Essenz just a bit. Maybe help us remind us on time lines from going -- from the kind of the targeted launch to an FMR separate U.S. versus Europe timing if there is a differentiation there. And then maybe how you're thinking about the potential impact of supply chain on that time line?

Do you want to...

Yes. So as we said all along, we're expecting a kind of a commercial launch in the fourth quarter. We're on track with that. We're not going to see a massive unit placement lift in Q4, but that should start to really pick up in Q1 of next year. So from a timing perspective, nothing has really changed.

Okay.

And we've said to people if you wanted to model it -- one of the things people have asked us is, is there a market for an upgrade? And do you know how to do it? And the answer is I would look at that sort of '18, early '19 period for HLMs, where we made a conscious effort to switch the S3s to S5s. So that shows us there's a willing market for an upgrade. And look, there are roughly 7,000 S5s out there now and 40% of them are past their useful 10 to 12-year life. So we know that there's a market. And then in that period, we taught the group in the LivaNova business just a methodology we taught that group about funnel management and how you move groups through the funnel. And so those 2 things, I think, play out and use that period as the analog for modeling.

Okay. So with 7,000 systems, 40% pass, that's kind of the right way to think about the?

Yes.

Okay. That's very helpful. And just a quick one on the potential for an air pocket ahead of time with patients, what's the plan for systems being sold, potentially sold through the course of the year?

Well, that's -- we factored that into our guidance this year. We anticipated a slowdown actually starting in Q1. We actually were pleasantly surprised that it wasn't any extent that we forecasted. So that's part of our guidance. And that it's -- we do expect a significant slowdown as we get closer to launch.

Okay. All right, that's helpful. We've touched on ACS a fair amount already, but maybe just one more on the ALung acquisition that you guys did, how it fits in the portfolio timing, kind of the key comments that you want to make around that?

Because you love this portfolio?

That was part of business development. So ALung is unique versus our traditional ECMO and most other systems out there. It's kind of a lower touch in the respiratory space. So it's not focused on the cardiac much more in the ICU and respiratory, and it's taking out the CO2. So you basically have much smaller cannula, as much less invasive which for a lot of those patients. The biggest part of the respiratory component of that market and respiratory is the biggest single component of the entire space. It's these kind of moderately severe patients, not the fully severe. And that's where this plays perfectly. So you think about things like ARDS, COPD, before COVID, those were big market potentials for respiratory. That's where this fits in perfectly. You can marry it with oxygenation, say, like a low flow nasal cannula and you essentially can create a system that can do much better than an intubated ventilator for those patients. So it's got a lot of potential over the long term. In the near term, it's going to be a controlled rollout. And as we said before, for this year, it's immaterial to the numbers, but that will change over time.

Over time, okay, great. That's great. I know a lot of interest in the pipeline, maybe transition there, the depression side. Maybe just start with an open-ended -- any update on -- I know we're at the point where we're rolling into the 25-patient cohorts. Any update that you want to provide?

Let me just say it's the first time in 6 months, we've got 2 depression, 30 minutes into a discussion.

We tried...

Normally it's the first thing. Yes, so we're past the 300, and we've got the signal just to keep enrolling, which we anticipated. So we're heading now to the 325, we're in a sort of a 4 to 6-week cycle for every 25 patients. And then once we hit that takes about 2 weeks for the analysis to occur. And we're sort of getting now into that sweet spot of the study where the stats start to point to the possibility of getting to the point where we can switch to registry.

Okay. I want to follow-up there. But first, just so we understand, are you receiving kind of a binary response from the team that's analyzing it or are you receiving additional information about it?

No, we absolutely no color -- to 3 checkboxes keep going stop because you hit positive predictive value. Actually, there's a third box. It's just stop because it's a few times. But we're pretty confident about not getting that.

Offering the utility -- so and then the time line expectation you kind of pointed to the analysis that you guys have done. What's sort of your kind of working assumption and what patient number does that approximate?

So we think between this current -- where we're currently at now, the next one being 325 patients and 375, if you look at the statistical power behind the study, that's where the predictive value starts to get better for us. So we've just gotten further through the study. There have been number of follow-up gets longer per patient. So between, I would say, 325, 375, it gets more interesting. So we're just entered that point.

Okay. So that's kind of a 3-month period if you take the 4 to 6 window and we're about to be approaching that so we're kind of looking from July, maybe a 3Q event is kind of our best working assumption right now?

Yes, correct.

Okay. All right, that's fair enough. I want to help kind of clarify what happens from that point forward. So maybe you can explain, let's assume an early successful trigger occurs in 3Q, what happens from that point forward, the time lines for what happens with that transition to registry and what's happening in the background until the next steps you're taking?

You want to talk on the transition, and we'll talk about one.

Right, so in terms of the transition to registry, if we get the go ahead from the independent statistician that we can stop enrolling, we would obviously tell all the sites, stop enrolling from unipolar. We do expect to put out something in an 8-K within 4 days of that. So we can't sit on that information. In terms of what's next -- we then -- the unipolar arm just goes to registry, which it's still a clinical trial. You sorted all the inclusion, exclusion criteria, but then there's no control arm, someone can get randomized into where they're off for a year. So for patients, it's much less onerous in terms of how the registry looks versus the current component. In terms of how it follows up, the next big event is the data. So we have to follow every patient enrolled in the trial for 12 months. So theoretically if we hit over the summer, a few patients will still be in the funnel to get their implant. So maybe a couple of weeks after we get this news, we have to follow them all for 12 months, then we become unblinded. So we would see the data, and you would all see the data sometime in the second half of 2023 -- and then the final component of this is we would package that in a peer-reviewed publication to a medical journal. When that is published, then we submitted to CMS in that form and then they make the new national coverage decision. So that would be -- we think that would happen in the back half of '24.

The back half of '24.

That they would make the decision on the changing coverage decision.

I mean there's no statutory time line for their review. So -- but once we publish the paper and we've already started conversations with the investigator team about what's the target journal, what are the things that -- let's write the shell of the paper. So all of that stuff, we're working as hard as we can to put things in parallel not sequentially.

Okay. So 2 half '23 would be the submission to -- the publication of the data, and that would be the submission to CMS and then it's essentially another year before?

Potentially.

Okay. Right.

That's what we forecast. Maybe that's a little quicker. And the options are they could maintain the non-coverage decision. We think that's -- if the data is positive as we assumed it would be, it would be hard for them given that this is their study to turn the coverage down. They could either go with a national coverage or they could go with allowing the regional MAC to make the decision. Either one is a win for us. We don't mind which one.

Okay. And how do we think about commercial kind of in the broader scope and...

Yes. So I'm hoping you're all going to let me do what Inspire does and just spend -- so you want me to be very aggressive about DTC. We know when these patients watch television. We've got a lot of really great data on a lot of their habits and what they read. And so we'll do DTC. We're doing a lot with the -- way we set up the study is we put in commercial people in the field to run the study on the premise that we were going to then keep them in the space to move into the commercial side. So one of the things I learned earlier when I was in pharma is if you have the 2 groups separated, the clinical people don't want to give up the study site, then the commercial people don't know who's who. It's the one team. So when we switch over to registry and commercialization, those people are already in. And we're using the 80 sites that we have as a real market for how to expand. We know where the DRG data is. It's basically funny enough, a big smile around the U.S. from Boston around to San Francisco. So we know where the therapy placement would start. So I think we're in a pretty good place for how to expand the commercial.

And Phil, before you get back to your commercialization. Just would you just remind us the recap on the registry piece and how that flows through to revenues for you and the kind of parameters there of what the kind of maximum impact could be?

The registry is essentially the same as the study. The difference is that there's no randomization. So one of the things that we know for sure, we know has slowed in entry is that 50% of the people are going to get in the sham arm. And -- that's not everyone's cup of tea, especially when you as debilitated as these major depressive events are. So we think one of the things that's going to be a bit of a tailwind is we'll be into a space where people won't be randomized. That will help. We've got 5,800 places available in the registry. It's pretty unlikely in our opinion that CMS would deny us the potential to expand that. I mean, WATCHMAN TAVR, they're still in registry. So we think, first of all, the 5,800 gives us plenty of runway in that 1 year that we're talking about. But also we'd be able to expand it if that was necessary.

But in terms of kind of ramping it without being able to market because it is in the context of a clinical trial, should we, in our models, assume there will be a ramp after you go to registry?

Yes, I think so. I think there's a gradual ramp. It's not a step function, but there's a gradual ramp because it becomes easier to access the places in the study.

Okay.

It's fair enough. Just before we leave it -- the bipolar arm, how we should think about timing there? I know it's much harder to enroll a patient subpopulation, so?

Yes, it's about 6 to 9 months behind, and the way I like to think of this is this is sort of almost like indication expansion for a molecule. You want us to get one of them done unipolar is 65% of the market, although we've been enrolling more like 85%, and all our effort has been to attracting those patients. We'll switch our search engine and our social outreach and social media over to the bipolar once we hit the unipolar.

A little bit of a broader question here is -- let's assume a lot goes right from a reimbursement standpoint. What do you view from a clinical perspective as kind of the biggest risk if you are able to achieve the data and the reimbursement that you think is warranted?

From a clinical perspective?

Yes, for application, where it fits the therapy fits, what are the risks as we get past?

What I think why we're so sanguine about the opportunity here is what happened a decade ago when there was approval and coverage for that 18-month period, there were something like 15,000 prescriptions written for it. We implanted about 3,000. There was another 1,000 that was scheduled. So -- and that was in the first 18 months of the release. At a time when it still wasn't really talked about as a disease state. You didn't talk about depression 10 or 12 years ago. You certainly didn't have as much acceptance for an implant. There wasn't even the term interventional psychiatrist than there is now. So we actually think that the market is in a much stronger position to -- and certainly likely to mimic what happened a decade ago because of those advances in how we think about depression and treating it.

Great, so pivoting over to the heart failure side of the equation. You have a pretty eloquent way of explaining what's different this time and why you have renewed confidence. Can you kind of summarize it for us relatively quickly?

Do you want to do that...

Yes, sure. So on the -- that trial design, it's different than RECOVER. RECOVER, we're focused on one endpoint to shift this to registry. Heart failure is a traditional FDA trial. And so the design of it because it's a unique study, it's an embedded study, there's functional endpoints we can look at earlier potentially to get FDA approval. But ultimately, what we're going for is a primary endpoint that's a composite score of mortality and morbidity. That's really the gold standard in heart failure, and that will take a little longer to get to, we need more patients. So we can do interim looks on the functional data and at the same time that we have to also show a safety signal and a trend towards the primary endpoint. And that's at the 60% probability that we'll get to the primary end point. And on the first look of those 5 different end points because there's 3 functional, the safety and the primary, we didn't hit at least one of them. We have to hit all 5 for essentially us to unblind the functional data. I think overall, the team is still pretty positive that things are trending the right way. Again, we're blinded. It's just like we covered independent statistician looks at it and gives us our sheet. Our thought is that in the primary endpoint trend, the event rate could be a little bit below where we predicted at this point in time because COVID does impact some of the hospitalization trends and it's hospitalizations that drive the mortality, morbidity endpoint in any of these heart failure studies. So adding another 100 patients which is our next look that will be later in the year, we just think we're going to have more power, more data points. So -- it should still lead to, we think, decent odds that the next look we can get there.

Okay. And can you remind us what's kind of different this time? This isn't the first DNS trial for heart failure. What's sort of different about where the therapy is today that gives you guys confidence that you're going to be able to get there at some point?

So there were 3 trials at all sort of presented around the same time. There was Boston Scientific at a trial. We had a pilot study, and then there was a company called In Control.

BioControl.

Sorry, I was saying In Control, BioControl that those 2 -- BioControl never reported the results, they were assumed it didn't work. And the Boston study just didn't show the efficacy. If you looked at the issues with each of them, they had issues with the dosing and the level of the dosing or the juice and then the frequency, the period. One was too high and one was too low. Ours was always sort of more in the middle, and we thought our pilot deal looked pretty strong overall. But even since then, looking at their data, we've tweaked ours to think much more, I think, in the kind of sweet spot of where the 2 marry to provide the most effect. So that was the premise for why we think ours will show different results than those other 2 studies.

Okay. Okay. And then compare and contrast the depression trigger, what happens differently with heart failure if you do have that successful interim look, what happens from that point forward?

That's a good question. So if we hit all 5, we can then unblind the functional data. We will present that. We can submit that to the FDA for approval. We would remain blinded on the primary endpoint. So we wouldn't know that data, we would trend to get that. So we could file, get approval and commercially launch on the functional endpoints while we're running the full trial. That's why we call an embedded trial.

Okay. All right. That's really helpful. Just a minute left. I thought we should touch on OSPREY as well. You already brought up Inspire. Just kind of position it for us, what the time lines are and why you think you'll be able to compete what's differentiated?

Yes, so we're still modeling mid-to-late '24 FDA approval. I think we have a product that's at least as good. It's easier to implant. It has less pain now and that's because we don't have a sensing lead -- and that apparently for the patients is the more painful aspect of the procedure. So we have, I think, a product that's going to be able to be implanted easier. It has more electrodes. So it stimulates the tongue differently. So there's less fatigue. And we think that the market clearly is showing a tailwind of moving towards implant for treating OSA. So in my mind, the best thing that ever happened to the statins was that multiple entrants came into the statin market, I think that Inspire and us could do a lot together.

And in the trial structure is a little bit different than what's been out there so far. Can you talk about that?

Well, it's a randomized study, which is an important difference. And I think that data is going to be more robust because of that. And we will have a very large data set. We released the THN3 data recently. That trial wasn't run well, which is part of the reason why we bought the company because we wanted to bring it under our control. But what we know about that and what we're putting into OSPREY, I think, is going to be a really robust trial. So in terms of reimbursement data, we're going to be in a pretty solid space.

Okay, that's great.

Sorry, Amit, we're right up on time.

Right up, it feels like, yes, we're getting crowded and right up on time. So Damien and Alex, Matt, thank you so much for the time and all the information. Wish you guys the best of luck. We'll talk to you on the second quarter earnings. Thanks, everybody.

Thanks from me. Thanks everyone for coming in.