Good day, ladies and gentlemen, and welcome to the LivaNova PLC, Fourth Quarter and Full-Year 2021 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Mr. Matthew Dodds, LivaNova's Senior Vice President of Corporate Development. Please go ahead, sir.

Thank you, Lydia and welcome to our conference call and webcast discussing LivaNova's financial results for the fourth quarter and full-year 2021. Joining me on today's call are Damien McDonald, our Chief Executive Officer, Alex Shvartsburg, our Chief Financial Officer, and Lindsey Little, our Senior 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 can 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, 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 in 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 Damien.

Thank you, Matt. Thank you everyone for joining us. Today, we reported our fourth quarter and full-year 2021 results. With full-year results meeting or exceeding the high-end of our guidance range. Before discussing the results, I want to provide you a brief update on the SNIA litigation. On February 21, the Court of Appeal of Milan notified us that it's suspended payment of the €454 million judgment until a decision has been reached on the appeal to the Court of Cassation, which is the Italian Supreme Court. This suspension is subject to providing a first demand bank surety of €270 million within 30 calendar days. We believe that we can satisfy the condition of the surety. Now, turning to our fourth-quarter results. I wanted to start off by discussing sales results followed by a review of strategic portfolio initiatives, after my comments, Alex will provide you with additional details on our results and 2022 guidance. Then I'll wrap up with closing remarks before we move on to Q&A. We're proud about fourth quarter results where excluding Heart belts, we experienced sequential and year-over-year revenue growth across all regions. For the full year, we are pleased to have achieved all our key financial targets. I'd like to highlight that effective fourth quarter 2021, we changed our segment reporting from two to three reportable segments. These reportable segments are Neuromodulation, Cardiac Pulmonary or CP, and Advanced Circulatory Support or ACS. The change reflects the way we internally managed, evaluate performance, and allocate resources. This new structure drags further accountability and execution and provides greater transparency to growth and margin profiles. Additionally, due to the impact of the pandemic on our prior year results, today's commentary includes certain comparisons to 2019. We believe this provide helpful context for the underlying trajectory of our…

Thanks, Damien. During my portion of the call, I'll share a brief recap of fourth quarter results and provide 2022 guidance. Before discussing results, I wanted to point out that during the quarter we identified and corrected an error related to foreign currency exchange rates, utilized the calculated inventory and cost of sales for the years 2017 through 2020, and the nine months ended September 30, 2021. This resulted in a decrease to inventory and an increase in cost of sales. Accordingly, prior period results have been revised on a GAAP and non-GAAP basis. See the revised financial information for 2020 and 2021 by quarter at supplemental information in today's press release. Additionally, my comments will reference the revised prior period results. Sales in the quarter were $270 million, an increase of 12% versus 2020, and an increase of 6% versus 2019 after excluding quart valves. Adjusted gross margin as a percent of net sales in the quarter was 70%, which was up 300 basis points for the fourth quarter of 2020. Adjusted gross margin was favorably impacted by product and geographic mix. Adjusted R&D expense in the fourth quarter was $41 million compared to $39 million in the fourth quarter of 2020. R&D as a percent of net sales was 15.1% versus 14.5% in the fourth quarter of 2020. R&D is increasing due to continued progress on our next-generation Heart-lung machines, as well as the RECOVER study and the ANTHEM HFrEF and OSPREY pivotal trials. Adjusted SG&A expense for the fourth quarter was a $107 million compared to $94 million in the fourth quarter of 2020. SG&A as a percent of net sales was 39.8% up from 34.7% in the fourth quarter of 2020. The increase was primarily driven by higher commercial investments in the U.S. for the ACS…

Thanks, Alex. As discussed throughout today's call, 2021 was a year of execution against our guidance and improvement in cash flow generation. While we ended 2022 with ongoing COVID related market headwinds, we remain committed to delivering sales and earnings growth, achieving our pipeline milestones, and improving profitability and cash generation. We believe the focus on the strategic triangle underpinned by the LivaNova's business system positioned us well to realize the full value of a diverse portfolio. With that, Lydia, we're open to questions.

Thank you [Operator Instructions] As we enter the Q&A session, please limit yourself to one question and one follow-up question, and then return to the queue if you have any additional follow-up. Our first question today comes from Adam Maeder of Piper Sandler. Your line is open. Please go ahead.

Hi Damien, Matt, Alex. Hope you guys are well. Thanks for taking the questions here and congrats on the progress this year. I wanted to start with just what you're seeing from a procedure environment standpoint, real-time. Just want to flesh out a little bit more. January, I'm assuming, January is a challenging month, like we've seen across MedTech. So we'd love some color there and then are you seeing -- have you seen things improved thus far in February? So if you could illuminate that, that would be great. Then along those lines, just how do we think about quarterly cadence and models Q1 versus the remainder of the year? Then I have a follow-up. Thanks.

Great, Adam. Thanks for joining us. Look, thanks for the question and I'll do a bit and then Alex, why don't you jump on in. I would say, like a lot of people that the year has been pretty much a [Indiscernible] for us as well. If you look at January, it was a little slower. In the U.S. the Epilepsy in the ICS businesses have been impacted more than Cardiopulmonary. In Epilepsy there's still a bottleneck in the new patient referrals. The surgical scheduling procedures being canceled or delayed, and we have people scheduled and then they did their turn-up and they got Omicron. Also the EMU workups and that's largely related to the staff shortages at the hospital. All of that was probably impacting new patients more than the replacements. I would say though that coming into February, the next part of your question, we've seen an improvement in net, the qualified late, the ops and picks as we refer to it, have definitely improved through February. Up in ACS, the staffing shortages have had the much pronounced effect on us. The ECMO patients, much more labor intensive. It's one-to-one versus like with advance it's one-to-four. We've seen some rigidity there. But again, starting to improve as the stops shortages in pockets look like they're improving. Do you want to talk about sizing?

Sure. Adam, just in terms of our phasing. I'd say that's a kind of normalized phasing. For Q1 is always a low watermark for us. This year we're going to skew higher in the second half, and this is primarily related to our expectation of the next-generation heart-lung machine launch, which is scheduled for the second half. And also clearly Omicron is still an issue as Damien just said in Q1, so definitely factor that in.

Okay. Got it, guys. That's helpful color. I appreciate that. Then maybe I'll just ask one more on the guidance front. I'll specifically asked about the Epilepsy guidance 5% to 7%. Damien, I think you talked about this a little bit in the prepared remarks, but can you just illuminate or flesh out the NPI versus replacements? How you're thinking about those two different pieces? As well as just geographic mix U.S., O-U.S. rest-of-world. I think I heard you say you expect NPIs to grow in 2022 but wanted to confirm that. So any more color there would be great. Thanks so much.

Sure. Adam, it's Matt. So for 2022, our expectation is both NPI and replacements grow, NPI slightly faster. We do assume that the international markets grow faster overall. That's mostly NPI driven.

Okay, helpful. Thanks again, guys.

Cheers, Adam.

Next question comes from Rick Wise of Stifel. Your line is open. Please go ahead.

Good morning, everybody. Damien, maybe let's start off with the -- it seems like good news about the suspended judgment. But this demand for surety, just a high level, is that -- are you hesitant to call a plead. But are you pleased with -- is that a positive step forward in your mind? As you, as you reflect on it, what are next steps in general now and timelines? Any incremental color there. Your comment about the surety, are you going to finance it? You obviously have you're generating cash internally or are you going to finance it with equity or debt? Maybe help us understand that as well.

First of all, hi, Rick, good to hear you. A few things. Let me talk about the case and then you jump in about the financing. The first thing for us is yes, we think this is a great logical step from the court. It didn't make sense to demand payment while we're still discussing the case. So I think it's really good decision from the court to suspend it until that case has been heard. I think you might have heard us talk about the fact that who case and the how much case have been joined. We'll expect to hear that sometime in 2022. So, I think it was a really great decision. It's important for us. In terms of financing, Rick, all along since we received the initial judgment in November, we had been planning for the worst case scenario. And so we have been looking at financing and we've lined up a short-term bridge facility to satisfy the [Indiscernible].

Good. And maybe just a couple of operational questions. Maybe just in general, what are you baking in in terms of the cadence of COVID recovery generally? Obviously, it sounds like second half's better, but many companies think gradual improvement throughout the year, is that where you're thinking about it? And on -- as it relates to ACS, what percentage of disposables there have been in COVID patients? And when you're talking about $0.20 guide there, what's embedded for COVID?

Again, in terms of the phasing, the expectation is we're going to see a slower Q1 and then improvements in Q2 and the back half of the year. Again, the phasing is also impacted by our capital equipment HLM business, which is going to be skewed more towards the second half of the year. For ACS, the fourth quarter was impacted by the staffing shortages as I mentioned, and it makes us more cautious about starting a new patient on ECMO to lift severe COVID or non-COVID. I think we talked about before the percentage COVID patients is 40 to 45 in the quarter, it was 43. We also think, as we talked about, with the fighting overall that will be a gradual improvement quarter-on-quarter. We've also been adding headcount and we added about 20 last year, most of them in the second half. So there's sort of coming online for effectiveness in this first half and we're planning to add another 20 in 2022 again starting now, so that'll become more effective in the second half. I think as COVID, improves the footprint, increases both from last year and this year. That's how we're thinking about the guidance as at least 20%.

And we expect, according to your last question, the percent of COVID will decline in 2022 and we think that will largely be made up by other respiratory usage, COPD, ARDS.

[Indiscernible]. Thanks for the solid fourth quarter performance. Relative to your excellent guide, great to see it. Thanks.

Thanks Rick.

Thanks Rick.

Thank you. Our next question today comes from Mike Matson of Needham and Company. Your line is open.

Yeah, thanks. I wanted to ask about the ANTHEM trial. I think you said you might be able to submit to the FDA mid this year. So with that, if we see that, does that imply that it hit all the endpoint?

Hi Mike, how are you? Matt, why don't you jump in? Sure. So for ANTHEM HFrEF, as Damien said, we hit the two milestones that allow the independent statisticians to start reviewing the data, which is underway. We think that will be done in two months or less. We have to hit all five of the endpoints. We talked about this before. Damien highlighted it’s safety, trend and mortality or morbidity, which is the ultimate primary endpoint. Then there's three functional endpoints. So assuming all five hit, then we do plan on submitting to the FDA, which we think could come around midyear. If we don't hit all five, it's an adaptive study so we keep going and we get the independent statisticians get to look at every 100 patients. So again, the next look would be at 500, which we expect to occur kind of in the later part of 2022.

Okay. Got it. All right. Surprised to see that the operating margin in ACS business was as high as it is north of 20%, I think. Maybe can you just comment on that and that sustainable and the expected to improve further from here?

I'm not sure where you're seeing the 20% margin on ACS. We've been investing heavily behind the business and we're going to continue to invest in 2022 as well. We don't expect to see much profitability coming out of that business.

Okay. I was looking at Slide 15, maybe I'm misreading and it was adjusted segment operating income and margin 21.9 per ARDS. Oh, that was last year. Sorry. I apologize, I thought --.

Yes. Sorry. Yes. Last year, obviously, we held back on investments.

[Indiscernible] the straight was where we started really putting a lot of support and resources in 2021. And that's where you say it, there's the press-all changes in 21.

Never mind that. Yeah, that makes more sense consistent with what I would expect given what you're doing with that business. Okay. And then finally, I just wanted to [Indiscernible] just the overall guidance. What have you assumed around inflation headwinds in your -- to the guidance and what sort of impact do you expect on your margins from that?

Yeah, we have incorporated the inflationary impacts, both from a labor perspective, particularly at the manufacturing levels and also continued expectations on higher freight costs. As we saw that throughout this year we're going to continue to see that in 2022, that's incorporated into our guidance. It's already assumed that we absorb those costs and of course we have our productivity efforts ongoing to help offset that.

Got it. Thanks.

Thanks, Mike.

Our next question is from Amit Hazan of Goldman Sachs. Your line is open.

Thank you so much. Just fill in for me. A lot of the areas have been touched so I thought just maybe a few follow-up items if I could. First, not hearing as much on the bipolar arm of the depression trial. I was hoping for an update there and try to understand a little bit better about the challenges around involvement and expectations for that one and waiting, sizing of that portion of the depression opportunity.

Hi, thanks for joining us too by the way. Omicron, overall, hit the recover study. And beginning to last week of December and the first two months of '22, we've really seen a slowdown in patients moving from the consent to implant. And a combination of the Omicron hitting patients and delaying their surgery or the clinical staff shortages. So it's been affected both arms, but on unipolar we're very close to implanting the 250th patient. And the pain a modest align enrollment. There, but it hasn't changed how we're viewing the transition to the registry. And like late 2022 or early 2023, that's for the unipolar, but almost trending behind. I mean, we modeled originally 65-35 in terms of recruitment, it's more like 85-15. And so we're staying a lot more unipolar. And as I said, on the Investor Day, we're really skewing our efforts to cranking through the unipolar arm, a bit like my indication expansion for a drug, pushing very hard on one indication, the unipolar is -- I think more important than hitting both of them. So we have seen a delay in the bipolar to what the back-end of the year.

That's great, Damien. Thanks. Just on that one, just to be clear, the unipolar and bipolar arms can be treated basically completely separately from an assessment and from a submission to the endpoint, right?

That's correct. Yes.

There's not a limit on unipolar prevalent bipolar side. Okay great. Then on Anthem hearing the progress in the enrollment rate roughly, sounds like roughly a 100 patients a year. I'm just wondering, you guys have been very gracious about giving unipolar expectations. Do you have a similar internal expectations for what level of patient event rate before you'll be able to potentially hit success? Is this first initial review flux embedded internally, or do you think it will be 500 or later to be able to achieve early success? Thanks so much, Damien.

Yeah, that's a good question. So for this it's sort of an embedded PMA, so it was designed to have the functional endpoints hit physical significance at nine months with 300 patients. Again, we have the safety, which we're pretty confident in given all the history of VNS. And then there's also a trend in mortality. We don't hit the mortality endpoint, that's designed for a larger follow-up. But of the five, they were all designed to hit at this level as opposed to more of a first look like you saw with some others. So we still have the ability to look at 500, 600 patients going about the first time. But you're right, the design was at this first look.

Okay, that's helpful. Thanks so much.

The next question comes from Zach [Indiscernible] of Jefferies. Your line is open.

Hi everyone, thanks for taking the question. Just one on the Heart-lung machines upgrade cycle that we're expecting to see the tail end of this year. How long do you expect that to last? Can you talk about some of the margin impacts from that upgrade?

Yeah. Hey, Zach. Thanks for joining us. The HLMs, I like the analog of what happened in late 17, 18, and to 19 with the S3 to S5 upgrade cycle and how we ticked up in terms of execution there as a way that people to math and model that process. We estimate there 7,000 S5 HLMs out there, varying somewhere between a few months old to 15 years old. Obviously, we'll start at a 15-year-old end of the funnel and we'll look our way through. We think that there's a good tailwind for two to three years in that conversion cycle. And then in terms of margin -- the gross margins for the improvement were anticipating approx. premium. And we're also expecting that by having the operations group starting to ramp volumes, we start getting better absorption at the plant level, particularly in Munich. So that should have a positive gross margin impact as well.

Got it. Thank you.

[Indiscernible]

Our final question today comes from Matt Taylor of UBS. Matt please, go ahead.

Hi, good morning. Thank you for taking another question. So first question I was going to ask was just about some of the puts and takes on gross and operating margin. I was hoping you could flesh that out a little bit with the impact of COVID and supply chain and maybe just talk about how we could consider the impact, not just for this year, but for future years where you could get to leverage and where you could get some pressure.

In Q4, I think the gross margin was pretty robust and there was this driven by our product and geographic mix. We talked about the operating margin was going to be slightly lower in Q4 relative to Q3 because of the fact that we pushed some spending out of Q3 into Q4. That's the color on 2021. As far as 2022 is concerned, we expect gross margins to increase about 250 basis points in 2022. We expect the increase from the product mix and also obviously the exclusion of the Heart Valves divestiture. As well as the efficiencies that are offsetting some of the supply chain costs. Just working our way down the P&L, we expect R&D as a percent of sales to increase slightly, as well as SG&A as we continue to increase our sales and marketing investments. Assuming that we're coming out of COVID to so higher travel commercial investments as well as the continued investments in our sales force expansion efforts across ATFs and a couple [Indiscernible].

Okay, thank you. Then I guess as a follow-up, is there any area in the supply chain where you're seeing critical shortages? It seems like you're managing through this relatively well, or are there places where you are at risk for any disruption or should we just view it as some increased costs?

Look, I would say, like every company we've been looking at this headwinds. I think the supply chain team has done a spectacular job. Some of the stories through Q4, both in logistics and distribution or the procurement team, to manage that were really solid. Some of the things we're doing, is we're giving suppliers a long range visibility and forecast. We've increased touch points and review with them so that we're particularly focused on the single-source or more critical components. Increased visibility on inventory. Part of part of the guidance includes an uptick in inventory. And we talked about some of the cost pressures, sort of split between SG&A and also COGS. In certain areas where we're building inventory. I think the key areas of microelectronics and [Indiscernible] rates of all things. And we're also -- but we're also watching transport costs. We're doing as much as we can near the balance that out. And the other bit is the inflationary pressure. So lead times in pricing. And the way to balance that again, is working with your suppliers on the long-range visibility. So I think we're putting, like a lot of really good steps. But again, I think like everyone we've got headwinds there.

Thank you for taking the question.

Thanks, Matt.

Thank you. We have no further questions in the queue, so I'll turn the call back to Damien McDonald for closing remarks.

Well -- and thank you, Lydia. Thank you for all of you for joining today. On behalf of the entire team, we appreciate your support. Thanks for 2021 and we're looking forward to 2022 and your interest in LivaNova. Thank you.

This concludes today's call. Thank you for joining. You may now disconnect your line.