LivaNova PLC (LIVN) 2021 Q4 法說會逐字稿

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 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 Damien.

Thank you, Matt, and 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 at Milan notified us that it suspended payment of the EUR 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 EUR 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 want to start off by discussing sales results followed by a review of our 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 are proud of our fourth quarter results where, excluding Heart Valves, we experienced both 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 2 to 3 reportable segments. These reportable segments are: Neuromodulation; Cardiopulmonary or CP; and Advanced Circulatory Support or ACS. The change reflects the way we internally manage, evaluate performance and allocate resources. This new structure drives 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 provides helpful context for the underlying trajectory of our business. These comparisons are reflected on Slide 20 of the earnings presentation.

Turning to our core growth drivers, Epilepsy and ACS. Global Epilepsy sales for the fourth quarter increased approximately 10% versus 2020 and 8% sequentially with growth across all 3 regions. Additionally Epilepsy sales on a full year basis were 28% above 2020 levels, which was in line with the midpoint guidance and 7% above 2019 levels. These results reflect our commitment to serving our patients and delivering sales growth, while navigating ongoing COVID-related challenges.

U.S. Epilepsy sales increased 11% versus fourth quarter 2020 and were 7% above 2019 levels. Total implants grew in the mid-to-high single-digits versus the prior year and were in line with 2019 levels. Similar to prior quarter trends, total implant growth was driven by replacements, which continue to benefit from the catch-up in procedures deferred due to the pandemic. Additionally, sales and implants improved sequentially with increases in both new patients and end-of-service implants. Our progress in U.S. Epilepsy continues to be supported by our go-to-market initiative, which currently encompasses 12 dedicated CEC teams. These teams accounted for approximately 19% of U.S. sales and implants in the quarter. They continue to deliver sales and implant growth that trended above the baseline business compared to the fourth quarters of 2020 and 2019.

Epilepsy sales in Europe grew 11% versus prior year led by the U.K. and Italy. We achieved growth of nearly 10% in the Rest of World region, led by a recovery in China, Taiwan and Brazil. Compared to 2019, Europe sales were unchanged while Rest of World sales grew 23%. For the full year 2022, we expect global Epilepsy sales to grow 5% to 7%. Our forecast includes growth in new implants in the U.S. as patients and their caregivers return to in-person physician visits and hospital capacity improves. In addition, we anticipate a continued tailwind in replacement implants related to the backlog created in 2020 that has continued into this year. We are pleased with the progress of the go-to-market initiative and the plan on adding 4 new dedicated teams in the U.S. during 2022.

ACS sales were $14 million in the quarter, representing an increase of 4% from the fourth quarter of 2020 and a sequential decline of 10%. Results were impacted by a reduction in patients treated with ECMO, given hospital staff shortages as well as capacity limitations. Notably, ACS sales for the full year was $55 million and grew over 30% in line with guidance. We expect ACS to grow at least 20% in 2022.

Turning now to DTD. Sales for the fourth quarter were $3 million and for the full year were $9 million. For 2022, we anticipate DTD sales of approximately $10 to $12 million, primarily from the RECOVER study. RECOVER study continues to progress and we're very close to implanting our 250 of unipolar patients and we'll communicate when this milestone has been achieved. While we remain focused on enrolling both the unipolar and bipolar cohorts, the unipolar cohort continues to enroll at a faster pace, primarily because it is a more prevalent patient population. As a reminder, we can submit the data from the 2 cohorts separately for transition to the prospective longitudinal study or registry. We still anticipate a transition to registry to occur for the unipolar cohort in late 2022 or early 2023.

In heart failure, the ANTHEM-HFrEF U.S. pivotal trial continues to advance. We are pleased to report that we recently achieved 2 key milestones. First, in late December, we enrolled the 400th patient. And second, in mid-January, the 300th patient completed the 9-month follow-up visit. Given these milestone achievements, the first interim analysis is being conducted by the independent statisticians. Once all pre-specified conditions have been met, including safety, a trend towards the primary endpoint and success in the 3 functional endpoints, we may submit the functional data to the FDA, which could occur as early as mid-2022. If we do not meet all the criteria, the independent statisticians will take another look at the data after the 500th patient is enrolled.

Moving to OSA, the OSPREY trial continues to advance with approximately half of the 20 study sites currently screening patients. While we have experienced delays in scheduling sleep test and surgery, we are excited to announce that our first patient is scheduled for surgery. We look forward to communicating when this key milestone is achieved. Importantly, we still assume submission for FDA approval in mid-2024.

For the Cardiopulmonary segment, sales were $133 million in the quarter, an increase of 12% versus the fourth quarter of 2020. Oxygenator sales increased by approximately 20% globally with strong growth in Europe and the Rest of the World regions. Heart-lung machine sales increased in the mid-single-digits, with over 40% growth in the U.S. offset by declines in Europe and Rest of World. Additionally, Cardiopulmonary sales were generally in line with 2019 levels for the quarter, but were below 2019 on a full-year basis, given COVID-related pressures on procedure volumes and the cadence of the HLM conversion cycle. We expect Cardiopulmonary sales to grow 0% to 2% for the full year 2022.

Lastly, Heart Valves was divested on June 1, 2021, and Heart Valves sales for the fourth quarter of 2020 were $24 million.

And with that, I'll turn the call over to Alex.

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 to calculate inventory and cost of sales for the years 2017 through 2020 and the 9 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, a 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 Heart Valves. Adjusted gross margin as a percent of net sales in the quarter was 70%, which was up 300 basis points from 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 machine as well as the RECOVER study and the ANTHEM-HFrEF and OSPREY pivotal trials.

Adjusted SG&A expense for the fourth quarter was $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 and Epilepsy businesses.

Adjusted operating income from continuing operations was $40 million compared to $47 million in the fourth quarter of last year. Adjusted operating income margin from continuing operations was 15% compared to 18% in the fourth quarter of 2020. Improvements in gross profit were offset by investments in SG&A.

The adjusted effective tax rate in the quarter was 14% compared to a negative 1% in the fourth quarter of 2020. The higher tax rate is primarily attributable to changes in the valuation allowance and geographic income mix.

Adjusted diluted earnings per share from continuing operations in the quarter was $0.57 compared to $0.70 in the fourth quarter of 2020. Adjusted diluted EPS from continuing operations for the full year was $2.07, which was above midpoint guidance.

Our cash balance at December 31, 2021, was $208 million, down from $253 million at the end of 2020. Total debt at year-end 2021 was $240 million versus $656 million at year-end 2020. These changes primarily reflect the impact of the equity offering and the term loan retirement completed during the third quarter of 2021.

Adjusted free cash flow for the quarter was $32 million and was $84 million for the full year, which exceeded the high end of guidance. Free cash flow generation was driven by higher earnings and improved cash conversion with free cash flow conversion ratio of 79%. We invested $26 million in capital, property, plant and equipment during 2021, which was $10 million lower than the prior year.

Now turning to 2022 guidance. We forecast 2022 sales growth on a constant currency basis between 3% and 5% and excluding the Heart Valves business. We assume an approximate 1% headwind from exchange rates. We are projecting adjusted diluted earnings per share from continuing operations in the range of $2.50 to $2.80. We assume adjusted diluted weighted average shares outstanding to be 54 million for the full year.

Adjusted free cash flow from operations is expected to be in the range of $90 million to $110 million. We forecast capital spending in the range of approximately $35 million to $40 million.

And with that, I'll turn the call back over to Damien.

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 entered 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 this strategic triangle, underpinned by the LivaNova business system, positions us well to realize the full value of our diverse portfolio.

And with that, Lydia, we're open to questions.

(Operator Instructions) Our first question today comes from Adam Maeder of Piper Sandler.

Damien, Matt, Alex, congrats on the progress this year. I wanted to start with just kind of what you're seeing from a procedure environment standpoint, kind of real-time just kind of want to flesh out a little bit more. January -- I'm assuming January was a challenging month like we've seen across med tech. So would love some color there. And then are you seeing -- have you seen things improve thus far in February? So if you could illuminate that, that would be great. And then along those lines, just how do we think about quarterly cadence and models, Q1 versus the remainder of the year? And then I had a follow-up.

Look, thanks for the question and I'll do a bit and then, Alex, why don't you jump on in. So I would say, like a lot of people, the year has been pretty much a matte for us as well. If you look at January, it was a little slower in the U.S. The Epilepsy and the ACS 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, the delay. And we have people scheduled and then they turn up and they've got Omicron. And also the EMU workups and that's largely related to the staff shortages at the hospital. So 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 that the qualified lead to the ops and picks, as we refer to it, have definitely improved through February.

In ACS, the staffing shortages have had the most pronounced effect on us. The ECMO patients are much more labor intensive. It's one-to-one versus like with [VNS], it's 1-to-4. So we've seen some rigidity there, but again, starting to improve as the staff shortages in pockets look like they are improving. Do you want to talk about phasing?

Sure. So Adam, just in terms of our phasing, I think as a kind of normalized phasing for Q1 is always kind of 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 in -- 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. Appreciate that. And then, maybe I'll just ask one more on the guidance fronts. I'll specifically ask 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 2 different pieces and then as well as just geographic mix U.S., OUS, 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.

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

Our next question comes from Rick Wise of Stifel.

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 it pleased, but are you pleased with -- is that a positive step forward in your mind? And as you reflect on it, what are the next steps in general now and timelines? Any incremental color there? And your comment about the surety, are you going to finance it? You obviously have -- you're generating cash internally, are you going to finance it with equity or debt? Maybe help us understand that as well.

A few things, so let me talk about the case and then you jump in about the financing. So 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 "who" case. And so I think it's a really good decision from the court to suspend it until that case has been heard. And I think you might have heard us talk about the fact that, that "who" case and the "how much" case have been joined and we'll expect to hear that some time in 2022. So I think it was a really great decision and it's important for us.

In terms of financing, Rick, so all along, since we received the initial judgment in November, we had been sort of planning for the worst-case scenario and so we have been looking at financing and we've lined up a couple of short-term bridge facility to satisfy the surety.

Okay, 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? I mean, obviously, it sounds like second half better, but many companies are saying gradual improvement throughout the year. Is that the way you're thinking about it? And on -- and as it relates to ACS, what percentage of disposables there have been in COVID patients? And when you're talking about 20% guide there, what's embedded for COVID?

So, again, in terms of the phasing, the expectation is, we're going to see kind of 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 essentially more cautious about starting a new patient on ECMO, so less severe -- COVID or non-COVID. We -- I think we've talked about before the percent of COVID patients is 40% to 45% in the quarter, it was 43%. We also think, as we've talked about with the phasing overall, that it'll 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 they're sort of coming online for effectiveness in this first half and we are planning to add another 20 in 2022 again, starting now, so they become more effective in the second half. So I think as COVID improves, the footprint increases, both from last year and this year, that's how we're thinking about the guide as at least 20%.

And we expect -- to go to your last question, the percent of COVID will decline in '22 and we think that will largely be made up by other respiratory uses, COPD, ARDS.

Our next question today comes from Mike Matson of Needham & Company.

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 would that -- if we see that, does that imply that it hit all the endpoint?

Matt, why don't you jump in?

Sure. So for ANTHEM-HFrEF, as Damien said, we hit the 2 milestones that allow the independent statisticians to start reviewing the data, which is underway. We think that will be done in 2 months or less. We have to hit all 5 of the endpoints. We did talk about this before, Damien highlighted. It's safety, trend in mortality or morbidity, which is the ultimate primary endpoint, and then the 3 functional endpoints. So assuming all 5 hit, then we do plan on submitting to the FDA, which we think would come around mid-year. If we don't hit all 5, 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. And then surprised to see that the operating margin in ACS business was as high as it is, north of 20% I think. So maybe, can you just comment on that? And is that sustainable and do you expect it to improve further from here?

Yes. And 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. So we don't expect to see much profitability coming out of that business.

Okay. I was looking at Slide 15, maybe I'm misreading it. It's the adjusted segment operating income and margin, 21.9% for ACS? Oh, that was last year. Sorry, I apologize, I thought it was this year.

Yes, last year, obviously we held back on investments.

And you've seen on the Street was where we started really putting a lot of our support and resources in 2021. So that's why you see it -- the profile changes in '21.

Yes. Okay. Never mind, that -- yes, 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 ask about just the overall guidance. What have you sort of assumed around inflation headwinds in your guidance and what sort of impact do you expect on your margins from that?

Yes, 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 and we're going to continue to see that in 2022. That's incorporated into our guidance. So it's already assumed that we absorb those costs and, of course, we have our productivity efforts ongoing to help offset that.

Our next question is from Amit Hazan of Goldman Sachs.

This is Phil on for Amit. A lot of the areas have been touched on. 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 enrollment, kind of expectations for that one and weighting, sizing of that portion of the depression opportunity.

So Omicron overall hit the RECOVER study and beginning the last week of December and the first 2 months of '22, we've really seen a slowdown in patients moving from the consent to implant and it's a combination of the Omicron hitting patients and delaying their surgery or the clinical staff shortages. So it -- and it's affected both arms. On unipolar, we're very close to implanting the 250th patient and there has been a modest delay in the enrollment there, but it hasn't changed how we're viewing the transition to the registry in late '22 or early '23. That's for the unipolar. Bipolar is trending behind. I mean, we modeled originally 65-35 in terms of recruitment, it's more like 85-15. And so we're seeing a lot more unipolar and, as I said on our -- on the Investor Day, we're really skewing our efforts to cranking through the unipolar arm. It's a bit like 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 towards the back end of the year.

That's great, Damien. 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 standpoint. Right?

That's correct.

Okay, great. And then, on ANTHEM, hearing kind of the progress in the enrollment rate roughly sounds like roughly 100 patients a year. I'm just wondering you guys have been very gracious about giving unipolar expectations, do you have a similar internal expectation for what sort of level of patient event rate before you'll be able to potentially have successes in this first initial review, sort of, what's embedded in internally? Or do you think it will be 500 or later, to be able to achieve early success?

Yes, that's a good question. So for this, it's a -- it's sort of an embedded PMA. So it was designed to have the functional endpoints hit statistical significance at 9 months with 300 patients. Again, we have to hit safety, which we're pretty confident in, given all the history of VNS. And then there is also a trend in mortality. We don't hit the mortality endpoint, that's designed for a larger follow up. But of the 5, they were all designed to hit at this level as opposed to kind of more of a first look like you saw with some others. So we still have the ability to look at 500, 600 patients, we're not the first time. But you're right, the design was at this first look.

The next question comes from Zach Weiner of Jefferies.

Just one on the heart-lung machine upgrade cycle that we're expecting to see at the tail end of this year. How long do you expect that to last? And can you talk about some of the margin impacts from that upgrade?

Yes, So the HLMs -- I like the analog of what happened in late '17, '18 into '19 with the S3 to S5 upgrade cycle and how we ticked up in terms of execution there as a way for people to map and model that process. We estimate there are 7,000 S5 HLMs out there varying somewhere between a few months old to 15 years old. Obviously, we'll start at the 15-year-old end of the funnel and work our way through. And so we think that there is a good tailwind for 2 to 3 years in that conversion cycle. And then in terms of margin, the gross margin should improve. We are anticipating a price 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. And so that should have a positive gross margin impact as well.

Our final question today comes from Matt Taylor of UBS.

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 those impacts, not just for this year, but for future years where you could get some leverage and where you could get some pressure.

Yes, so in Q4, I think, the gross margin was pretty robust. And that was driven by the -- our product and geographic mix. So 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. So that's kind of the color on 2021. As far as 2022 is concerned, so, 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 kind of 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, so higher travel, commercial investments as well as the continued investments in our sales force expansion efforts across ACS and Epilepsy.

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

Look, I would say, like in every company, we've been looking at these headwinds. I think the supply chain team has done a spectacular job. I mean some of the stories through Q4, both in logistics and distribution or the procurement team to manage that work were really solid. Look, some of the things we're doing is we're giving suppliers better long-range visibility and forecast. We've increased our touch points and review with them so that we're particularly focused on a single source or more critical components. We've increased our visibility on inventory. 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, we're building inventory. I think the key areas are like microelectronics and epoxy resin, of all things. And we're also watching transport costs. We're doing as much as we can there to balance that out. And the other bit is the inflationary pressure, so lead times and pricing. And the way to balance that, again, is working with your suppliers on the long-range visibility. So I think we've put in place a lot of really good steps. But again, I think like everyone, we've got headwinds there.

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

And thank you, Lydia, and thank you for all of you for joining today. On behalf of the entire team, we appreciate your support. And 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 lines.