Good day, ladies and gentlemen and welcome to the LivaNova PLC Third Quarter of 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I'd now like to introduce your host for today's call, , Mr. Matthew Dodds, LivaNova's Senior Vice President of Corporate Development and IT. Please go ahead.

Thank you, Alex, and welcome to our conference call and webcast discussing LivaNova's financial results for the third quarter of 2023. Joining me on today's call are Bill Cozy, our Chairman of the Board of Directors and Interim Chief Executive Officer; Alex Shvartsburg, our Chief Financial Officer; Stephanie Bolton, President of Global Epilepsy, and Briana Gotlin, Director of Investor Relations. Before we begin, I would like to remind you that the discussions during this call will include forward-looking statements. Factors that could cause actual results to differ materially are discussed in the company's most recent filings and documents furnished to the SEC, including today's press release that is available on our website. We do not undertake to update any forward-looking statement. Also, the discussions will include certain non-GAAP financial measures with respect to our performance, including, but not limited to, sales results, which will all be stated on a constant currency basis. Reconciliations to the most directly comparable GAAP financial measures can be found in today's press release, which is available on our website. We have also posted a presentation to our website that summarizes the points of today's call. This presentation is complementary to the other call materials and should be used as an enhanced communication tool. You can find the presentation and press release in the Investors section of our website under News Events and Presentations at investor.livanova.com. With that, I will now turn the call over to Bill.

Hey, thank you, Matt, and thank you everyone for joining us. Welcome to LivaNova’s conference call for the third quarter of 2023. Before turning to results for the quarter, allow me to provide a brief update on the CEO search. Our process remains on track, and the board and I are currently interviewing select candidates. We are encouraged by our progress and are committed to selecting the right individual to lead the company. For the remainder of the call, I'll discuss our third quarter results and then turn to our strategic portfolio initiatives. After my comments, Alex will provide additional details on our performance and updates to 2023 guidance. I'll wrap up with closing remarks before moving on to Q&A. In the quarter, we achieved 12% revenue growth versus the prior year marked by double-digit growth across all regions and improved profitability. Our performance reflects strong execution throughout the organization as demonstrated by the growth in all three business units. Notably, we maintained our commitment to modest leverage, achieving adjusted operating income growth of 23%, contributing to value creation in the quarter. Now turning to segment results. For the Cardiopulmonary segment, revenue was $145 million in the quarter, an increase of 18% versus the third quarter of 2022. Oxygenator revenue grew in the mid-teens, driven globally by higher-than-expected demand, again. And I'd like to acknowledge our cardiopulmonary manufacturing and supply chain team on their excellent performance in the quarter. Heart-lung machine revenue increased more than 25%, driven by Essenz installations in the U.S. and Europe and S5 placement in the rest of the world region. At the end of August, we received U.S. FDA 510(k) clearance and CE Mark for the Essenz In-Line Blood Monitor in the U.S. and Europe respectively. These clearances are important product milestones that enable increased…

Thanks, Bill. During my portion of the call, I'll share a brief recap of the third quarter results and provide commentary on 2023 guidance. Turning to results, revenue in the quarter was $286 million, an increase of 12% versus 2022. Foreign exchange in the quarter had a favorable year-over-year impact of approximately $3 million, or 1% of revenue. Adjusted gross margin as a percent of net revenue was 71%, compared to 70% in the third quarter of 2022. Adjusted gross margin was impacted favorably by realized price, higher volume, which drove favorable fixed overhead absorption, as well as lower inbound freight costs, which offset component cost inflation. Adjusted R&D expense in the third quarter was $42 million in line with third quarter of 2022. R&D as a percent of net revenue was 15%, down from 16% in the third quarter of 2022. While flat on a dollar basis versus the prior year, R&D expense declined sequentially, largely driven by lower costs associated with closing out the ANTHEM Trial. [Including] (ph) the cost related to ANTHEM, our R&D investment increased 4% versus the prior year. Adjusted SG&A expense for the third quarter was $115 million, compared to $98 million in the third quarter of 2022. SG&A as a percent of net revenue was 40%, as compared to 39% in the third quarter of 2022. The year-over-year increase was driven by targeted investments supporting the Essenz launch, legal expenses, and variable costs such as freight and commissions associated with increased revenue. Adjusted operating income was $45 million, compared to $37 million in the third quarter of last year. Adjusted operating income margin was 16%, compared to 15% in the third quarter of 2022. Adjusted operating income was driven by improved gross margin and operating expense leverage. Adjusted effective tax rate in the…

Hey, thank you, Alex. As a company, we have executed against our targets through the first nine months of 2023. We're well positioned to deliver on our full-year guidance, including operating leverage by year-end, as well as pipeline commitments. Achieving these communicated goals and creating shareholder value are top priorities of the executive leadership team and our colleagues around the globe. Let me take a minute to thank our entire organization for their focus on patients, innovation, and value creation. We look forward to building on this level of performance through the remainder of the year and into 2024. With that, Alex, we are ready to open the call for questions.

Thank you. [Operator Instructions] Thank you. Our first question for today comes from Rick Wise of Stiefel. Rick, your line is now open. Please go ahead.

Good morning, everybody. Thanks. Bill, let me -- first of all, it's great to see the solid quarter overall, clearly a lot of good things happening. And you make a bunch of encouraging comments. And I said that before I start off with the fourth, I just want to touch on the fourth quarter. When I -- if I'm looking at it correctly, your current guide, even though it's stepped up a bit, implies a bit lower growth in EPS than I might have thought and that we had modeled. And just wanted to better understand, is this just thoughtful, prudent conservatism? Is there something I'm not understanding? Is this something related to tax rate? If you could just give us a little more color there and understand?

Sure, Rick. Thanks for the question. Getting right at the EPS range. We have been all throughout the year really paying close attention to not only sales and profitability performance, but also this balance of supporting some well-known needs we have infrastructurally, manufacturing, innovation, and some strategic investments. We have notably been cautious on the latter set of choices that we've made to ensure that we put the first three quarters of the year into a strong position. We do have some targeted investments in the core business around growth and profitability, and we're going to support some of those investments in the fourth quarter. Additionally, we can't predict this ongoing competitor supply situation, particularly in the CP business and very much focused on oxygenators and the impact it's going to have on volume and our ability to achieve the same amount of sales and the corresponding EPS benefit. We get from that. We got a few ongoing inflationary pressures we've got our eyes on, particularly on components. But hopefully, I’ll give you a little better picture of where we're sitting right now.

Got it. And just, and again, it's always management's favorite question the time of year. Maybe you'll talk a little bit about the 2024 setup. You made some encouraging comments there at the end, Bill. Maybe you could expand on that a little bit, just key drivers for next year or things the organization and you are focused on? But maybe most particularly, given the strong cardiopulmonary performance, how much more -- how long should we anticipate that running, that benefit lasting? What inning are we in there as we look ahead to the year ahead? Thank you very much.

Yes, Rick, thank you. Let me take the latter part of that question first. Just to be clear, our manufacturing organization on the cardiopulmonary side focused on oxygenators are running flat out right now. We don't have any more available capacity. Everything that we make, we sell. We were surprised that our competitors have not yet seemingly put much greater volume back into the marketplace. And so I have given up trying to predict, if and when that's going to happen, because we just don't know. We mentioned to you guys last quarter that we were pretty sure they were going to be back. Clearly the numbers we just showed you, they've not popped back. I actually have been asking a lot of the same questions you're asking about the upcoming year. We can't project that and we won't. As it relates to 2024, we really are looking forward to covering that in much greater detail, Rick, with you and all others when we do our fourth quarter call. We had an encouraging and successful board meeting in October where we took our strategic business plan for the coming year, and let us just defer that discussion until we get to the fourth quarter results.

Thanks very much, Bill.

Hey, Rick, thanks.

Thank you. Our next question comes from Mike Polark of Wolfe Research. The line is now open. Please go ahead.

Hey, good morning. Thank you for the question. One more on cardiopulmonary, and I'm specifically looking at the implied fourth quarter guidance. If I'm doing the math right, segment revenue down sequentially and year-on-year, it just strikes me as very conservative. The question is on the oxygenator disruptions at competitors, can you remind us on the timing of that over the last year or 18-months? Was that primarily a 2023 phenomenon or are there some tough comps in the back half of 2022 that we're coming up upon?

Hey, Mike. Yes, thanks for the question. You're on to a really important topic. And by the way, this is our math and our math only, but we did start to see the first escalation in the oxygenator revenue uptake in the fourth quarter of ‘22. So number one, we know that we're up against a little bit of a tougher comp as we go into that quarter. Number two, and please excuse me, I'm not trying to be repetitive here, but we're just running flat out in the plants. I can't and our organization can't produce any more oxys. So when we do our projections based on those two critical factors, we're having a really hard time seeing how we could sustain the double-digit growth. So once we're in the fourth quarter of ‘23 against that tougher comp and as we look forward on oxys, we can't see the sustainability. Now, of course, we're looking at everything we can do in the short-term to optimize our production capabilities. But you guys know well, we've got molding, assembly, packaging, and sterilization here. There's just no magic want where we can, in a very short-term, create a notable recovery scenario. And by the way, we are operating well within all the quality boundaries of our quality management system to make sure that we're not just optimizing volume, but everything that's going out of that facility is at the quality levels we expect. So by the way, I'm not in any way complaining about all that. I'm just sharing that we're doing the absolute best that we can in the situation that we have.

Helpful. For my follow-up, I'll ask on the CEO search, appreciate the comments. I guess as I look at LivaNova, you know, I -- my question is, is it difficult to find the right fit before you know, you know, what happens with depression and sleep as examples? Those are potentially transformative opportunities to clear clinical data risk? And I just, is it -- I roll this forward, Bill, and kind of wonder if a better timing for somebody new would be middle or back half of next year when you maybe know a little bit more about these pipeline programs and how the data is going to turn out and therefore the potential commercial prospects? Any color on this would be great. Thank you so much.

Yes. Thanks for the question. Actually we have been pleasantly encouraged by the number of people, who want to be a CEO. The same questions that you have asked, we have been getting asked in our process. But I see no hint that it's dampened candidate interest and people coming to the company. As I mentioned in my early remarks, our -- the board and myself are in and have been in some active interviewing now since late August, early September. All our attention is on finding the right person. We said initially it would more likely take six to nine months. We kind of moved a little past the six month window, but we'll continue to do two things. Keep the process at the level of quality that we have it and we're not flexing on our spec. When we say we're going to find the right person, we've described over the last couple of calls those things that are really important to us in terms of getting the right candidate and we're just staying connected to that.

Thank you.

Sure, Thank you for the question.

Thank you. Our next question comes from Adam Maeder of Piper Sandler. Your line is now open. Please go ahead.

Hi. Good morning, guys. Thank you for taking the questions and congrats on the next quarter. I wanted to start on CP…

Hey, thanks. Good morning.

Good morning. I wanted to start on specifically CP and heart-lung machines. And I think you said that segment grew 25%, HLMs did in Q3. I'm curious if you can just talk a little bit more about the Essenz rolled out. What was the contribution in the quarter from Essenz? How many systems did you place? And how do you foresee that evolving going forward? And then also just remind us on the pricing strategy relative to S5 and then I had a follow-up. Thanks.

Sure, thanks for the question. We did move, as I mentioned in my earlier comments, to kind of a full launch. And for sure, our HLM revenue growth was driven primarily by Essenz installations in the U.S. and Europe with just some S5 placements in the rest of the world. All of our Essenz orders to-date are achieving the expected price target. We have talked in the past that we were expecting to, because of the quality advancements in technology in Essenz, we were hoping to get around about a 30% price premium above traditional S5. At this very early stage, all of that expectation is being achieved. We're not yet at a point where we're going to start talking about units placed. What we actually are enthused about is the quality of our pipeline and funnel and the customer interests that we're seeing in both U.S. and Europe. So what we hope to do is prove ourselves even to the next level, if you would, in the fourth quarter, and then we can circle back some more on Essenz performance as ‘24 starts to roll out.

That's great color, Bill. Thank you for that. And for the follow-up, realize you're not -- you’re a little bit limited in terms of what you can see on ‘24, but I did want to ask about the heart failure program closure. I think that's $24 million to spend this year. Any updated thoughts, even just broad strokes on how you think about that spend as it relates to next year, letting that flow through to investors versus reinvestment in the business? And then I guess I'll test my luck and also ask about associated spend with depression and OSA next year as well. Thank you.

Because -- you're letting me, I'm going to have Alex comment on our heart failure. He's got his real tight handle on our game plan there.

Hi Adam. So look our heart failure program, we continue down the path of closing that out by the end of the year. We expect some residual cost into next year. We're -- you know we're looking at you know our capital deployment as part of our budgeting process. We'll update you guys as we end Q4 on all of our expectations for performance in next year.

And to close out on your DTD OSA questions, what we did, as you would expect in our business planning, is the best we can do, given the little bit of uncertainty that resides, particularly on DTD, is do scenario planning. We have completed scenario planning for a possible launch of that product, obviously not until we get into ‘25, but we would have to start to prepare our homework for late 2024 commercial activity. That's what we'll talk about when we get into our fourth quarter review. And we'll actually be prepared to give you quite a bit of insight, I think, in both of what we're going to try and do, why we're going to do it, and what that spend will be. As you would already asked, there are more than a few moving parts there. And so we're going to take the benefit of the next couple of months to really button that down, but we have a really good kickoff on that planning effort. And of course, the scenario has to operate under the financial premise that depression has a chance to be a goal and more details to follow.

All right we'll stay tuned. Thanks again.

Hey thank you.

Thank you. Our next question comes from Matt Taylor of Jefferies. Your line is now open. Please go ahead.

Hi. Thank you for taking the question. I guess, I was wondering if you could talk a little bit more about the epilepsy dynamics, you know, under the hood and give us some color on trends in new patient starts, you know, the replacements, also the things that you've been doing with your salesforce, you know, how the landscape's been with the centers opening and maybe carry that forward and talk at least at a high level about what to expect with those dynamics next year?

Hey, Matt, thanks. We've got the benefit of having Steph here, and she has been spending ordinate amounts of time on these two topics. So I'm going to just turn that question right over to Stephanie Bolton.

Thanks, Matt. So as mentioned during the last call that we had, we've really been focusing on producing consistent performance and having a consistent execution. And I continue to be encouraged by what that looks like with the team, particularly in the U.S. So we keep leaning into our consistent operating mechanism and focusing on the fundamentals of the collaboration between the different groups. Our Q3 was another, sort of, consistent execution quarter. And our NPI entirely in line with our expectations, given how we exited Q2. So I'm really pleased that we'll continue to anticipate that normal run rate as we move through towards the end of the year. So in terms of the sales teams, they are very much focused on our customers that have the most amount of opportunity to treat our DRE population. And we continue with our CEC strategy with our cams in the field. So everything is moving in a very nice direction and we continue to work on our consistent execution.

Very good. Anything notable to call out in terms of changing dynamics next year in the business?

No, no, notable changes as it stands now. We have full and appropriate coverage in the U.S. of our CECs and they remain our firm priority moving forward.

Okay great, thank you very much.

Thank you.

Thank you, Matt.

Thank you. Our next question comes from Mike Matson of Needham & Company. Your line is now open. Please go ahead.

Yes, thanks, I guess just you know good to see the strong growth in ACS. So, you know, is that, do you think that's back to kind of steady strong double-digit growth now?

Well, we continue to keep our eyes on that. When we had -- let me give you just a little bit of color on the ACS side. I mentioned just briefly that we had some case volume benefit. In fairness, we had a couple of other smaller tailwind events that happened in the quarter. And that related to some backorder clearance, a few minor catch-ups in purchases in Europe, and a one-time adjustment in service revenue. And so it was the combination of those three things that kind of elevated that year-on-year growth for ACS. We're maintaining, kind of, our full-year guidance, continuing to work closely with our ACS leadership team to look at how we can further grow and improve profitability in the year ahead. But our guidance remains pretty much what we mentioned to you last time.

Okay, thanks. And then just as far as OSPREY goes, you know, good to hear that you've got all the sites up and running. You can use any sort of update on where enrollment is and what your expectation is in terms of when the data could be released. Is it possible? We could see in ‘24, is there really going to be more ‘25?

Yes, I'm going flip that one right to Matt.

Sure, thanks Mike. So OSPREY, as Bill said, was on track. You know, we've talked about getting the enrollment completed in 24, six months follow-up. To your point, you know, it looks right now like kind of late ‘24, early ‘25, we'd get the data, you know, a little bit of time to analyze it and that's why we've talked about a filing in ‘25.

Okay, got it. Thank you.

Thank you. Our next question comes from Anthony Petrone of Mizuho Group. The line is now open. Please go ahead.

Thanks. Maybe one on epilepsy and then I'll ask a little bit about margins. Maybe just a little bit more on end of service. I know the company is actually tracking those patients. Just wondering where you guys are in terms of how many patients are still in the queue for end-of-service, and would assume that most of those would be, if they choose to upgrade, they would upgrade at SenTiva? And then I'll have a follow-up on margins.

Hey, thanks, Anthony. I'm going to flip that one over to Steph.

Sure. Hi, Anthony. Nice to speak to you. So each quarter, we have an overview of our identification for both end-of-service and MPI. And I continue to be encouraged by what that looks like. And for sure, you're absolutely right. The end-of-service patients that we have coming through now are opting to move to our SenTiva platform. So again, we're seeing incremental improvement. And that's the piece that you see around the mix and the change. So that's with end-of-service patients opting to move to our latest platform.

And again, in terms of the tailwind, I mean, is -- can that last all the way through 2024 into ‘25? Or are you ending the end of the queue there on end-of-service? And then just quickly on margins, just to recap on the amount of R&D spend on recover and then under a scenario where you don't get an ideal readout there I'm wondering will those R&D dollars be redeployed elsewhere in the business or would you let those fall to the bottom line? Thanks again. Congrats on a good quarter here.

I think what I'd like to say in terms of end-of-service, we keep updating our models every single quarter. So we should have more information on that towards the beginning part of next year. Due to the fact that a number of our patients are opting for SenTiva, and we launched in 2017, so we're starting to see the first replacements of those, we'll continue to see a slightly higher end-of-service identification, because of that reason. But we'll keep you updated with that.

And Anthony, on depression, the RECOVER study burn is approximately, call it $30 million on an annual basis. And so, you know, to answer your question about how do we think about capital deployment for next year, again, as I said, you know, we'll update you guys, you know, early in 2024 about how we're thinking about our budget and guidance for next year. Obviously, there's multiple scenarios as they relate to depression.

But that depression will be fully funded throughout 2024 unless we get some kind of unexpected news in June of 2024.

Correct. Thank you.

Hey, thanks for the question.

Thank you. Our next question comes from Matt Miksic of Barclays. Your line is now open. Please go ahead.

Thanks so much. Can you hear me okay? A - Bill Cozy We can. Good morning.

Great. Terrific. Good morning. Thanks and congrats on the quarter.

Hey, thanks.

So yes, just one question following up on some of the work that you're doing with the -- in the epilepsy business. I guess maybe Stephanie or the team. Is this something that, given the new implants in a quarter, seemed like they maybe dipped a bit? You said it was in line with your expectations. Just to get us a sense of the cadence for the year and how we should think about Q4 and how you're entering ‘24, is that something we should expect to kind of sequentially improve or is there another quarter or two of internalizing some of the new programs and a pipeline concept that would put the improvement in trench into ‘24, then I had one follow-up.

Yes, hi Matt. So as I look specifically at Q3, and the reason why I say I continue to be encouraged by that sort of consistent execution is when we look back towards Q2, we had a 13% increase in our MPI for that quarter. So it is entirely in line with my expectation that we saw what we did in Q3. In fact, because I was -- I continued to be encouraged due to the fact that we didn't see a dip. Now, When we look towards the fourth quarter, I'll refer you back to the original full-year guidance that we gave in terms of mid-single-digit for MPI and end-of-service. So we anticipate a normal run rate for the fourth quarter.

Okay, thanks for that. And then just to follow-up on sort of cash flows and maybe the ability to sort of reinvest here and your maybe priorities for reinvesting, some of the R&D spend that you're unwinding into the end of this year. If you could provide any color on your most recent thought? And I understand there's a stock plan underway, and there's a new CEO potentially coming on board soon. And you want to get ahead of that, but your latest thoughts on how to think about that adding back to the P&L and being redeployed for what kinds of investments? Thanks.

Matt, this is Alex. I'll take the free cash flow. Our target for this year is $85 million to $95 million of adjusted free cash flow. Our goal is to continue to drive cash conversion. That's what the organization is focused on. That is assuming an expectation that we continue to see improvements in profitability and work in capital management. As far as capital deployment for next year, we’re not ready to talk about that at this point. Obviously, there are multiple scenarios in terms of success with depression and getting us ready for a potential launch there. We'll update you guys as we get into 2024 early in the first quarter.

Okay, fair enough, thanks.

Thank you.

Thank you. Our next question comes from David Rescott of Baird. David, your line is now open. Please go ahead.

Hey guys, thanks for taking the question. I wanted to start on essence and kind of the margin contribution from that segment. I appreciate the comments around the pricing premium. I know it's really in the early days here, still just getting underway, but just wondering how we should think about maybe the contribution or leverage from that product as that ramps and as you move into 2024 beyond just relative to the rest of the portfolio?

So this is, as far as Essenz margins are concerned, we expect, sort of, some margin improvement as we scale the volumes there. The cost base is slightly higher and we obviously compensate for that with our price premium at this point. Essenz, as it continues to ramp into 2024, will have a margin improvement for the cardiopulmonary business. Our capital business has a higher margin base than our consumable business. So slightly different perhaps from other companies, but that's the way we think about the business. That Essenz will have a strong contribution to our gross margin improvement in 2024.

Okay, that's helpful. And then just two quick follow-ups on I think some prior comments that you made actually at our conference. Just wondering one, I think the prior expectation maybe had been to have a CEO replacement in place by January of 2024. So wondering if that's still the expected timeline? And then second, I think we had asked in the past just about whether or not any of this concern or anything you're seeing around GLP-1s are impacting the enrollment of the OSPREY trials. I just wonder if there's any updated thoughts on both of those? Thank you.

Hey, thank you. I'll take the first one. You're exactly right. We had talked back in April at the time of my arrival about a six to nine month window. And of course, that nine month window would take us into the January time frame. As you would guess, we're not operating under any deadline. We're going to find the right person. We'll know that right person when we see them. Every effort is being made to get that person in sooner. I want to make sure that, that commitment is clear. At the same time, we'll find that right person, and we won't be pushed by any time frames or calendars or anything. So the Board's very sincerely committed to the spec, as I mentioned just a few minutes ago. And I don't think we're going to see as waiver from that. Now Matt, would you comment on the GLP-1 please?

Sure, on the GLP-1s we don't believe we're seeing any impact on the enrollment of OSPREY. And also, you know, that trial is relatively small, 125 to 150 patients as our expectations. So we're not seeing anything.

Okay, great. Thanks.

Hey, thank you.

Thank you. Our next question is a follow-up question from Mike Polark of Wolfe Research. Your line is now open. Please go ahead.

Hey, thank you for taking the follow-up. Just one, Alex, I thought in your prepared remark you said something about the tax rate. What did you say? What's a good input in ‘24, ‘25?

Yes, thanks Mike. Recall from our Investor Day in December of 2021, we kind of foreshadowed an increased tax rate. At that time, we were saying that over the course of 2022 to 2024, we'd expect the tax rate to be in the range of 15% to 20%, where we're going to see that happen in 2024. So that's what I would recommend that you guys start modeling.

So I just want to be clear, though. This is for your adjusted reporting. The adjusted tax rate goes from something like 10% this year to 15% or 20% next year? And if that's true, what's driving it? I mean, what are the changes?

Yes, that is correct. The changes are we're enjoying a very low tax rate today. It's very different versus, if you look at some of our competitors and we expect that to, kind of, normalize as some of our tax planning. We lose the benefits of some of the tax planning that we've enjoyed over the last few years.

Okay, it's just that feels, yes, it feels like a big step up. So, okay, I appreciate the comments. Thank you.

Hey, thank you.

Thank you. At this time, we currently have no further questions. So I'll hand it back to Bill Cozy for any further remarks.

Thank you everyone for joining us on today's call. On behalf of the entire team, we appreciate your support and your interest in LivaNova. Thank you.

Thank you.