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

Thank you, Emily and welcome to our conference call and webcast discussing LivaNova's financial results for the fourth quarter and full year of 2023. Joining me on today's call are Bill Cozy, our Chair 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 financial 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 statements. 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 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 fourth quarter and full year of 2023. Before turning to results in the fourth quarter and full year, I'll start off with some comments on the naming of Vlad Makatsaria as CEO, our decision to wind down the Advanced Circulatory Support segment, and an update on the cybersecurity incident. Earlier this month, the Board appointed Vlad is the company's CEO and a member of the Board of Directors effective March 1st. Vlad most recently served as a Company Group Chairman at J&J MedTech, leading its global Ethicon surgery business. He's a respected leader in the medical technology industry, with a 27-year track record of delivering results, driving innovation, and leading high performing teams. The Board and I have great confidence that Vlad is the right CEO to advance LivaNova’s strategic plan and achieve our goals for long-term growth. I will continue in my role as leading over Board Chair, and of course look forward to supporting Vlad as our new CEO. In January, we announced the wind down of the ACS segment. As part of this decision, ACS’ standalone cannula and accessories will move into our cardiopulmonary segment during the first quarter. This portfolio decision allows us to focus on our core cardiopulmonary and neuromodulation businesses, which are well positioned for growth and value creation. We expect the wind down to result in a positive contribution to adjusted operating income in 2024, as compared to 2023. We delivered strong performance despite the previously disclosed cybersecurity incident. Later in the call, Alex will provide comments regarding excuse me the estimated impact to our financial results during the quarter. Importantly, we were able to bring all our manufacturing operations back online as noted in…

Thanks, Bill. During my portion of the call, I'll share a brief recap of the fourth quarter results, I'll offer additional details on the one time charges in connection with the cybersecurity incident, and the wind down of the ACS business. I'll also provide commentary on the 2024 guidance. Turning to results, revenue in the quarter was $310 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 68% compared to 69% in the fourth quarter of 2022. The cybersecurity incident impacted adjusted gross margin by approximately 100 basis points due to unfavorable labor costs and fixed overhead absorption. This was partially offset by higher volume and favorable product mix. Adjusted R&D expense in the fourth quarter was $42 million, compared to $43 million in the fourth quarter of 2022. R&D as a percent of net revenue was 14%, down from 16% in the fourth quarter of 2022. The year-over-year decrease was largely driven by lower costs associated with the close out of the ANTHEM trial. Excluding the costs related to ANTHEM, our R&D investment increased 9% versus prior year. Adjusted SG&A expense for the fourth quarter was $120 million, compared to $100 million in the fourth 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 revenues. Additionally, our short-term incentive plan accrual increase resulting from the business over performance. SG&A as a percent of net revenue was 39% as compared to 36% in the fourth quarter of 2022. Adjusted operating income was $48 million, compared to $47 million in the fourth quarter of last year.…

Thank you, Alex. In 2023, we exceeded full year guidance on the top and bottom line, and did generate operating leverage. We realized these results while maintaining full investment in our pipeline initiatives, investing in critical capabilities for the company as mentioned, and taking actions related to portfolio optimization. I certainly want to take the chance to thank our entire organization for their hard work and dedication demonstrated in 2023. Under interim leadership, the organization embraced some change and seized performance opportunity as reflected in these results and that has been very much appreciated. Looking ahead, our core businesses are focused on targeted innovation, sustained growth, and value creation. Additionally, our SPIs are fully funded with data milestones approaching. With Vlad as CEO, I have great confidence in his leadership, and that LivaNova will maintain momentum, achieving our commitments to serving patients while creating shareholder value. With that, Emily, we're now ready to open the call for questions.

Thank you. [Operator Instructions]. Our first question today comes from Rick Wise with Stifel. Please go ahead.

Hi, good morning, everybody. Hi, Bill and welcome Vlad. Maybe it's hard to resist starting off since it's the first time I'm having the pleasure of speaking to you. Maybe you could talk us through at a high level your priorities as you step into the role, as broadly or deeply as you'd like in terms of operational goals or innovation, the strategic pipeline, I mean, who are you and what should we expect from your leadership? Thank you so much.

Hey Rick, this is Matt. Well I really wish -- is that Vlad was not on there. He starts March 1, so he is not on call. But Bill could comment on -- it's okay, but Bill can comment briefly on -- and initially some thoughts on Vlad.

Sure. Let me jump in. And we talked to you over several months about the spec that the Board had and the standard that they had created for this hire. As I mentioned a little bit we've got somebody -- Vlad coming into lead the company with 27 years of experience, including significant time, living and working around the world, internationally. A career that moved Moscow to Singapore to London to New York in a major health care company. He not only checked all the boxes on the spec, he's been accountable for multibillion dollar global business with more than 15,000 employees, overseeing all commercial R&D, operational and supply chain activities. His proven interest in vision strategy, innovation, talent, market access, and execution closely aligned with the requirements that we had set in place for the role. As you know, Rick, we took a lot of questions about the timing of the hire. We just wanted to emphasize that we intentionally tried to stick to our specification. And speaking on behalf of the Board. I know that the entire Board is extremely pleased with Vlad’s to join LivaNova.

That's great. That's good to review. And Bill, I should have started with congratulations on all you've done in taking LivaNova to this point. It's really impressive. Just as a follow-up question, maybe take us through the current competitive situation on the oxygenator side and again, help us think through your capacity expansion, where are you, where can it be, I think you said, if I heard correctly we are going to see expansion in the second half but do you have any sense that competitors are coming back to level set us in our business? Thank you so much.

Yeah. Thanks, Rick. That's a good question. And one that is front and center here. First of all, at this point in time, nothing has really changed on the competitive side. We still, as we've mentioned to you before, we had one smaller competitor who's positioned and continues to dissipate. We have a major competitor who has not yet returned to the market. We don't have a timeframe on that. All of our best efforts in the field to determine that remain just still uncertain. Product capacity side, we told you we were going to work. And we've identified several process improvements within the manufacturing operations to increase capacity. And we're right now taking actions to implement those. We're not ready yet to conduct -- predict the level of improvement that we will get but we are confident that in the second half of the year, these benefits will start to have some positive impact to upscale our ability to supply.

Great, thank you.

Hey, thanks, Rick.

The next question comes from Anthony Petrone with Mizzou. Please go ahead.

Thanks. And congratulations, Bill on the role as Interim and Vlad coming in here shortly as of March 1st. Maybe just to follow up on -- you are welcome. First question will be a follow-up on oxygenators just as we look over the next few years. And again, wondering how much share actually has the company gained and how sticky can that be, if and when competitors do come back? And then I'll have a couple of follow-ups on guidance.

Sure, we -- there's no external data. And of course, when you get into particularly the growth markets around the world, it becomes very, very difficult. But if you kind of tried to benchmark us Anthony at 30%, maybe about 15 to 18 months ago our best guess and let me underline the words best guess is we might be sitting right now in the mid-30s somewhere. We know that about half of our high volume business is tender based. And so we know that we've got a good, steady position there. Our challenge will of course be to sustain our current revenue position in a non-tender oxygenator business. And our sales force is highly aware of that, and it's got significant focus on that. You'll get nothing but a best effort to sustain that business. And we are particularly well organized in those growth markets I talked about before to do that.

That's helpful. Maybe Alex, just a little bit on guidance. When we look at the earnings bridge for 2024, you have additional tax inflation in there, but you're seeing some benefits, still residual from heart failure. And then ACS, I think you've called $0.10 out for ACS. Just maybe to look at that relative to where that business has been running, from a cost standpoint, is that the early benefits and should we expect sort of a bigger step up once that's fully analyzed, again, because the timing here is suggesting that the operations won't be fully wound down until the end of the year, so just a little bit on the earnings bridge and the moving pieces? Thank you.

That's right, Anthony. So the ACS wind down this, this is I'll call it a transition year. In 2023, the business incurred 14 -- approximately $14 million of losses. So we're essentially part of the wind out, we expect to see significant improvements in that year-over-year. And then next year, realize the full benefit of that.

That's helpful. And then just one quick one and I'll get back in queue, just the phasing of that, is it gradual or are there certain sort of features of that wind down that can happen sooner or should we just be thinking this is all back-end loaded, just in terms of phasing it out through calendar 2024? Thanks again.

It's going to be -- it's going to be -- it's not fully back end loaded, but it's going to happen in the last three quarters of the year.

Thanks again.

Sure.

Our next question comes from Michael Polark with Wolfe. Please go ahead.

Hey, good morning. Question on the cardiopulmonary guidance for 2024, 6% to 7% growth. Can you confirm Alex is that -- that's apples to apples, it has no benefit from the cannula and accessories from ACS?

That's correct, Mike. The cannula business, we will recast all the results at the end of Q1. So we'll have apples to apples comparisons. This guide is assuming an apples to apples comparison, the growth profile of that line of products is roughly the same as the broader cardiopulmonary portfolio. So from a growth perspective, it's apples to apples.

And ACS was 40 million last year, if I look at how you guided did this year, it kind of implies 20 million of ACS is being exited, the 2% give or take. Does that mean the cannula and accessories in total on a full year basis last year was about 20 million?

It's I'll -- give you the exact number, it's 15 million.

Okay. Okay. I think that was my first topic. The second is just this. The step up in CAPEX, I heard critical investments in innovation, growth infrastructure, those are fairly generic terms. What exactly does it mean, it sounds like oxygenator capacity definitely, is there anything else and I'm thinking specifically about depression and/or sleep readiness investments? Thanks for taking the questions.

Hey, Mike, it's Bill. Let me grab that one. You hit the first one perfectly. Yes, it's oxy capacity and significant planning going on right now and particularly in the main facility in [indiscernible] to address that. Additionally, we already had some commitment to improve our IT infrastructure. The event, the cyber event really encouraged us in a very, very serious way okay, to look even more broadly at our systems. So you will see an uptick in our IT investment, as a percent of sales for LivaNova, you will see us moving a couple of basis points north of where we have always operated as we number one, strengthened our security position and number two, modernized a number of targeted systems which were natural entry points for others that were active. Those are high priorities for us.

Yeah, I would just add to that Mike, we are really focused on modernizing our ERP systems as well. We had that in kind of our long range, three-year plan. We are also accelerating those efforts into 2024.

Thank you.

Okay, thanks Mike.

The next question comes from Matt Taylor with Jeffries. Please go ahead.

Hi, thanks for taking the question. I just wanted to clarify on your comments on the depression study. You mentioned that you'll get the results in June. Are we still going to see the results in June or might we have to wait till July? So that's the first question. And then I guess just thinking about the different scenarios, can you talk about what you might do in kind of middle of the road or less good scenarios, we know what you'll do if the trial is successful and build behind that, but what are you going to do if you have kind of a mixed result or a poor result, can we see savings like we've seen with heart failure and ACS or what's the middle of the road scenario mean for spending?

So yeah, so let me start Matt, it's Matt. So for the timing, as Bill said, we'll get the data in June. Our plan is to release the top line data, but we still have to get confirmation from other critical parties, including those publishing at CMS before we can confirm that. So worst case, again, as we've said, you'll see it when the publication comes out likely at the end of the year, but the hope is we can release it in a timely manner. In terms of the way to think about the trial, there's a lot of data points, right. So we talked about the primary endpoint, timely response. There's multiple other endpoints, multiple other things we're looking at. CMS cares about several other endpoints. So it's really hard to say right now, how we can, what we would do with the data until we see it. I don't know, Bill, if you want to comment on, if the data doesn't read out in a favorable way at all, if there's a different path.

Yeah, the only thing we'd add to that, this as everybody knows the whole way that this was a high bar set by CMS and the number of endpoints in a randomized clinical trial of this type, again, confirms the high expectations that were there. We've already had Jonathan and his team taking the time to just take a look at scenarios that might depict the data outcome. And of course, you could say well, we're going to hit every endpoint. And by the way, that's a possible scenario, but let's wait and see. You may not hit a couple of those and then you're into that ambiguity situation, which I think you were starting to get at. That's the work that we've still got to do, but without the data and without some specific direction from CMS, it's really hard for us to say exactly what's going to happen because we want to do the work once we've seen the data too. We are blinded. We've told everybody a number of times that this is the part where it gets a little more frustrating to wait.

We're getting closer.

We're getting there.

Great. Thanks for the talk, guys.

The next question comes from Adam Maeder with Piper Sandler. Please go ahead.

Hi, guys. Congrats on the finish to the year and thank you for taking the questions. I wanted to pick up on that same topic, depression and SPIs, and maybe I'll ask it a little bit differently, but just trying to understand what is the level of SPI spend for depression and OSA that's baked into the guidance for 2024 and specifically wondering if the guidance accounts for some of the preparatory costs to push forward, assuming a positive trial on depression and then I had a follow-up or two? Thanks.

Hey Adam, it's Alex. So we spent roughly $32 million in 2023. We are anticipating a modest increase on that spend in 2024. The level of spend really depends on just how compelling the data is. And once we know as to how kind of the trial's trending and the results in June will make a definitive decision around the level of investment.

And the market debt, there was an interest, there was a sub question there about, is there anything in?

There's a small amount of market development spend incorporated into the guide in OSA.

OSA.

Yeah. And as far as OSA goes, we spent roughly $27 million in 2023. We expect a modest step up in investment in that program as well as we continue to enroll and follow patients through the end of the trial.

That's great, color. Thank you for the clarification there. And for my second question, wanted to flip over to CP and the outlook for 2024, the 6% to 7% growth. I heard some of the prepared remarks, but was hoping you could put a little bit of a finer point on what's assumed in that guidance for HLM growth versus Oxys, what are you assuming for the oxygenator competitor issues? And then just one clarification on a cybersecurity incident in Q4 of last year, what was the revenue impact and reasonable to assume that was more on the CP side of the business? Thanks for taking the questions.

All right, let's take this one at a time. So as far as the guide goes, and we expect double-digit growth in the heart-lung segment in our guide. The guide also assumes that due to the capacity constraints and our expected benefits, as Bill mentioned in the second half, a modest sort of low to mid-single-digit growth rate on the consumables. Now, the next part of your --

Yeah, go ahead. Sorry.

What was the second part?

Just wanted to clarify, the cybersecurity -- yeah, sorry, cybersecurity impact in Q4 from a revenue standpoint, what did that look like and I think that was on the CP side of the business, but wanted to confirm that? Thanks.

That's right. So the incident impact is the oxygenator production. We lost about a week of production. Kind of hard to track exactly the impact on revenue because it really depends on how the inventory flows and when you expect to see sort of the capacity constraint or the inventory constraint that would result in lost revenue. It wasn't material.

Got it. Thanks, Alex.

The next question comes from Mike Matson with Needham. Please go ahead.

Yeah, good morning or good afternoon. So just in terms of the tax rate, I think before you talked about kind of 15% to 20%, now you're looking at like 21%. So I guess, why did it end up being higher than you expected and is this mainly through the pillar two or is there something else going on? And then have you, I'm assuming you haven't baked anything in for the stock-based compensation benefits into that 21% guidance?

So when we were looking at the range at a point in time, Mike, it was really difficult to predict because the tax rate is a function of jurisdictional profitability. So as we got closer to exiting 2023, looking at projections for 2024, we got a better sense for how the mix of profitability will work out. 21% is our best estimate at this point in time. And yeah, I'm not sure I understand your question around the stock-based compensation.

I just thought that typically there's some kind of tax benefit from stock-based comp, but companies generally don't factor that into their guidance or tax rate, it's kind of unpredictable?

Let us come back to you, and I will follow up on that if that's okay with you.

Yeah, sure. And then just wondering what you've assumed in the guidance for gross margin benefit from Essenz, just given the price premium there, is it going to help your gross margins in 2024, and how much do you think that'll help?

Yeah, it absolutely supports a gross margin improvement. We're expecting a modest gross margin improvement of about, call it 100 basis points year-over-year, overall as a company. So Essenz plays a major role in that.

Okay, got it, thank you.

You're welcome.

Our next question comes from David Rescott with Baird. Please go ahead.

Hey guys, thanks for taking the questions. I want to start on the Neuromod segment. I think the guide that you called out maybe was this mid-single-digit new patient growth and low-single-digit replacements, but ultimately getting to I think the 6% to 7% product guide for the segment as a whole. So just, I think if you do the math you're getting to something at or below that 6% to 7%, so wondering if pricing is a piece there, if I'm understanding the way in which you laid out guidance for Neuromod specifically? And then I think the segment itself has done better in 2023, and you've talked about the inability for that and a higher level of growth to be sustainable. So just wondering where we stand from that point, are we at a point at which Neuromod is seeing some structural changes to the replacement cycle or to the new implant cycle where we can start to think about better growth in Neuromod, just any clarity there would be helpful?

Steph will take that.

Hi David, I'll take that. So in regards to the epilepsy business for U.S. MPI, so we're continuing to forecast that we'll be mid-single-digit. You're right when you talk about the U.S. sort of end of service elements. So we expect to return to a more normalized low-single-digit rate, but we still expect to see the international region continuing to grow low-double-digits. So that's why you've got the sort of 6% to 7% there. We do continue to model end of service and every quarter we do a bit of a refresh on some of our expectations there. And as I say, our latest data tells us that we'll be experiencing more normalized end of service in 2024. As a reminder, 2022 was a really favorable comparison to 2023 and our performance in 2023 has been very positive. So we do expect to see the growth rate become much more normalized as we move through 2024.

Okay, and then just to follow-up, I know it's been a while since we talked about the Italian reserve. So just wondering where we stand and can you give us an update around what the timeline is there, and then maybe what you're potentially thinking about longer-term around the flexibility, the balance that that could open up if and when that kind of moves to the rear view? Thank you.

Hey, David, it's Alex. So with regard to the SNIA litigation, we're awaiting a binding decision from the European Court of Justice. We actually expect that readout in 2024. That will then funnel its way into the Italian Supreme Court and so we expect the Italian Supreme Court to incorporate and issue a decision in response to all the appeals of LivaNova and the counter appeals. So that may make its way into 2025. With regard to the capital structure around this, as you know, we took on the term -- in 2022. That was the funding that we kind of ring-fenced to serve a potential liability. At this point in time, from an accounting perspective, we haven't booked the liability because we do not have any indication that we will be liable. But we have the appropriate funding and cash to support a negative judgment against us.

Okay, thank you.

The next question comes from Matt Miksic with Barclays. Please go ahead.

Hey, good morning. Thanks for taking the questions and congrats on a great finish to 2023. I had one follow-up on the neuromodulation business and epilepsy and just wondering if you could give any sense on following up on the comments on market trends and sort of market sort of stabilization, I guess, normalization in 2024, where are we or how are you feeling about the changes that you've made to the sales organization, to the selling process, to the way in which you're focusing your folks on different centers around epilepsy in the U.S. and the benefits that you're seeing there, how sustainable they are, and I had one follow-up?

Sure, thanks for that, Matt. I continue to be really pleased around the consistent execution and our financial performance certainly reflects that. And I think when we look towards how we're structured, I've dug in a lot over the past nine months since being in this role. And where we are fully staffed and disciplined in our execution, we do see consistent growth over the base business with our key accounts and how we've structured ourselves over the past couple of years. So I'm really pleased to see that group continuing to perform well and perform over the base. But one point I would like to make is our strategy is sort of broader than the salesforce structure. And in combination with our territory design, we've been making big efforts around expanding our partnerships with our physician base. In fact, we have our first scientific advisory board coming together for the first time over this coming weekend. And you'd be highly impressed by the caliber of those members. So more to come. So consistent execution is the way forward for us in the epilepsy side of the business. But also more to come in regards to our partnership with our physician base as well.

Well, thanks for that. And I've been hopping back and forth here between a couple of calls. So I apologize, Bill and Alex, if you've already kind of talked about it. But we'd love to get a sense of where things stand with the STRAP plan as Vlad gets ready to step into his new role, is that a first quarter call kind of communication for us or is that a second quarter, any kind of update and again apologies if you've already gone through that, Bill?

No, no, Matt, glad to take that call. At this point, we're just a little over a week away from Vlad starting. All the orientation discussions we've had, he seems pretty comfortable with the current state of the company. But he will, of course, be fully encouraged by the Board and personally by me to bring any and all ideas forward. The company would traditionally go a little deeper on its strategic planning effort as the early summer approaches. So the timing for him is great. He gets here in May. He's got a couple of months to get grounded. That process starts up pretty active in June, July. And to be clear, he has full CEO responsibility, including strategy. And so the process and the approach that he wants to bring on March 1st is going to get full support from the Board.

Got it, I look forward to that. Thanks so much.

Sure, thanks.

We have no further questions. I'll turn the call back to Bill Cozy for closing remarks.

Thank you. We thank everyone for joining us on today's call on behalf of the entire team. We appreciate your support, your interest in LivaNova. Thanks again.

Thank you everyone for joining us today. This concludes our call and you may now disconnect your lines.