Good day, ladies and gentlemen, and welcome to the LivaNova PLC Third Quarter 2022 Earnings Conference Call. My name is Charlie and I'll be the coordinator for today's call. You will have the opportunity to ask your question at the end of the presentation. [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. Please go ahead, sir..

Thank you, Charlie. And welcome to our conference call and webcast discussing LivaNova's financial results for the third quarter of 2022. Joining me on today's call are Damien McDonald, our Chief Executive Officer; Alex Shvartsburg, our Chief Financial Officer; 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 in 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 Damien..

Thank you, Matt. And thank you to everyone for joining us. Welcome to our conference call for the third quarter of 2022. I'll start by discussing our third quarter results and reviewing our strategic portfolio initiatives. After my comments, Alex will provide additional details on our results. I will wrap up with closing comments before moving on to Q&A.

In the quarter, we achieved 5% revenue growth, reflecting solid execution in Neuromodulation and Cardiopulmonary. Advanced Circulatory Support remains unfavorably impacted by a significant decline in severe COVID cases and hospital related challenges.

More broadly, as a company, we continue to navigate macro headwinds, including supply chain, inflation and foreign exchange volatility. Now turning to segment results. For the Cardiopulmonary segment, revenue was $121 million, an increase of 7% versus the third quarter of 2021.

Oxygenator revenue grew in the high-single digits, driven by continued procedure volume recovery. Heart-lung machine revenue increased in the mid-single digits led by growth in the rest of world region. We now expect Cardiopulmonary revenue to grow 8% to 10% for the full year.

This range considered the strong performance in the first nine months of the year and continued demand for the S5 HLM, particularly in the rest of world region. Epilepsy revenue increased 11% versus the third quarter of 2021, with growth across all three regions.

This performance was primarily driven by replacement implants, as well as improving market dynamics and focused commercial strategies. US epilepsy revenue increased 9% year-over-year, with total implants up mid-single digits with price contributing the balance.

Similar to prior-quarter trends, total implant growth was driven by replacements which continue to benefit from a catch up in procedures deferred due to COVID related challenges. Additionally, both new patient and replacement implants improved sequentially.

US epilepsy results continue to be supported by our go-to-market initiative, which currently encompasses 14 dedicated CEC teams. These teams accounted for 22% of US implants in the quarter as compared to 20% on a same account basis during the prior year. This key commercial strategy continues to deliver implant growth above the baseline business.

Epilepsy revenue in Europe grew 6% versus prior year, primarily led by the Nordic region as acute pandemic impact softened. The rest of the world region achieved 28% growth, led by Brazil. For the full year, we now expect global epilepsy revenue to grow 6% to 8%.

Our forecast includes sequential growth in new patient implants in the fourth quarter, as we expect healthcare related challenges to modestly improve. In addition, we anticipate a continued tailwind in replacement implant related to the backlog created during the pandemic.

We're pleased with the progress of the go-to-market initiative and plan to add two additional dedicated teams in the fourth quarter. ACS revenue was $9 million in the quarter, representing a decrease of 44% from the third quarter of 2021. Results were impacted by continued reduction in severe COVID cases, hospital-related challenges and product mix.

Our field data suggests ACS case volumes related to COVID declined more than 90% year-over-year, as fewer hospitalized patients progressed to a severity that required ECMO therapy. Notably, ACS non-COVID case volumes increased more than 20% year-over-year.

Results in the quarter were modestly impacted by our field action relating to the LifeSPARC controller. Before turning to the ACS outlook, I wanted to provide a brief update on the field action and related Class I recall. In July, we notified customers regarding modifications we made to the operations manual for the LifeSPARC controller.

This addressed situations during which certain users were incorrectly stopping the pump in response to a screen error message. At the end of September, the FDA classified this as a Class I recall.

Importantly, the FDA is not requiring that we remove the product from the field and the device is considered safe for use when used in accordance with the operations manual. Patient safety is our top priority. And before year-end, we expect to release a software upgrade to address the screen error message.

Now turning to our revised outlook for the ACS business. For the full-year 2022, we now expect ACS revenue to be down approximately 30%. And forecast has been updated to reflect the disappointing third quarter results and the impact of the FDA recall. Turning now to our strategic portfolio initiatives. DTD revenue for the third quarter was $2.1 million.

And for 2022, we now anticipate DTD revenue of approximately $8 million. The RECOVER study continues to advance. The randomized controlled study is designed with frequent interim analyses that will assess if predicted probability of success has been reached or if the study should continue enrolling.

As stated previously, we believe a series of interim analyses is likely needed as we collect patient follow-up data over time. Our interim analyses for the unipolar cohort to date have confirmed the study's continuation, with the next interim look at 400 patients expected by the end of this month.

We still anticipate a transition to the prospective longitudinal study for the unipolar cohort in late 2022 or early 2023. In heart failure, ANTHEM-HFrEF US pivotal trial continues to advance.

The independent statistical analysis committee will conduct the next interim analysis after the 500th patient is enrolled, which we anticipate will occur in the fourth quarter, with a read-out early in the first quarter of 2023.

If all the pre-specified conditions are met, including safety, a trend towards the primary composite endpoint and success in the three functional endpoints, we would expect to submit the functional data to the FDA. Moving to OSA, the OSPREY trial continues to progress. All 20 study sites are active and recruiting patients.

We still assume submission for FDA approval to occur in the latter half of 2023 with a decision anticipated in 2024. Finally, I wanted to provide a brief update on the SNIA litigation. As planned, the Supreme Court hearing took place on October 5 regarding the appeals of liability and damages, and we anticipate a decision in the first half of 2023.

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 the third quarter results and provide commentary on the full-year 2022 outlook. Turning to results, revenue in the quarter was $253 million, a 5% increase versus 2021. Foreign exchange had an unfavorable year-over-year impact of approximately $14 million or 5% of revenue.

Adjusted gross margin as a percent of net revenue was 70%, which was in line with third quarter of 2021. Adjusted gross margin was favorably impacted by product mix, offset by supply chain challenges and inflationary pressures. Adjusted R&D expense in the third quarter was $42 million compared to $37 million in the third quarter of 2021.

R&D as a percent of net revenue was 16%, up from 15% in the third quarter of 2021. While sequentially flat, the year-over-year increase was driven by lower spend in the prior-year period. Adjusted SG&A expense for the third quarter was $98 million compared to $93 million in the third quarter of 2021.

SG&A as a percent of net revenue was 39%, up from 37% in the third quarter of 2021. Similarly, the SG&A increase was driven by lower spend in variable expenses and marketing costs in the prior-year period. Adjusted operating income was $37 million compared to $46 million in the third quarter of last year.

Adjusted operating income margin was 15%, down from 18% in the third quarter of 2021. The adjusted effective tax rate in the quarter was 8% compared to 10% in the third quarter of 2021. The lower tax rate is attributable to changes in discrete items in geographic income mix.

Adjusted diluted earnings per share was $0.58 compared to $0.66 in the third quarter of 2021. Lastly, in the quarter, we recorded a $129 million non-cash goodwill impairment charge for the ACS reporting unit to reflect current market conditions, which is excluded from our non-GAAP results. Now turning to our balance sheet.

Our cash balance at September 30 was $506 million, up from $208 million at year-end 2021. Our current cash balance includes $275 million of restricted cash held as collateral for the SNIA litigation guarantee. Total debt at September 30 was $540 million, up from $240 million at year-end 2021.

The increase primarily relates to the $300 million initial term loan facility that we executed in July. Net debt including restricted cash at September 30 was $95 million. Adjusted free cash flow for the quarter was $41 million compared to $40 million in the prior-year period.

Capital investments were $17 million in the first nine months of the year compared to $18 million in the prior year. Now turning to our 2022 outlook. We are maintaining our guidance ranges shared in August as we continue to navigate supply chain challenges, the inflationary environment and anticipated foreign currency headwinds.

We expect constant currency revenue growth between 4% to 6%, excluding heart valves, and adjusted EPS range of $2.25 to $2.45 and an adjusted free cash flow range of $60 million to $80 million. Our outlook now assumes a 5% revenue headwind and approximately a $0.35 EPS headwind from exchange rates. Back over to you, Damien..

Okay. Let's open it up for questions, Charlie..

[Operator Instructions]. Our first question comes from Rick Wise of Stifel..

Let me start off with your epilepsy performance. Obviously, it was a very solid performance. You were very clear about some of the drivers there. Help us think through both the drivers of performance this quarter, the C team contribution to growth.

And help us understand, again, as you work through your backlog, how much is left? And how we make – what kind of transition you're expecting, growth transition you expect as the replacement backlog gets worked down?.

It's Matt. Let me let me start with kind of the trends. Overall, I'd say, first and foremost, if the market we do think improved a bit in the third quarter, some of the bottleneck at the EMU, we think, loosened up a bit. It's still an issue, but we think it improved a bit. Your question on our go-to-market, we increase the implants from 22% to 20%.

So that drove a higher number than the overall business. I would say, looking at what we have left on the EOS, again, it's not perfect math. But our algorithms show that we have about 300 patients left. As s you can tell from the quarter, EOS was very strong both year-over-year and sequentially. But we still think we have 300 left.

For next year, we're not giving guidance yet on any specifics. But as I think you can surmise, we do not expect EOS to have quite the same performance in 2023. So, we're looking for the new patient growth to accelerate next year.

Both in the community and the CECs, which is why we're pleased with the continued pod structure performance, it's still outperforming the baseline business considerably. We're going to add another two this quarter. And that'll bring us to 16. The coverage now is increasing. I think we're at roughly 30%, 35% of the CECs are covered.

And that's up, again, another couple of percentage points. So we're really pleased with how that's growing..

There's so many things to talk about. I guess it's hard to resist to asking a little bit about 2023. I know you're not ready to give guidance, you just said it. Nor should you. But it's hard for us not to think about the setup for next year. Just at a high level, maybe Damien, you could talk through.

Matt just highlighted some factors helping us think about the epilepsy business next year. But at a high level, based on what you know now, what are you more optimistic about? And what should we be optimistic about? From a growth perspective, what are you more concerned.

No touchy feely, but hoping you can give us something as we start to put our – revisit our models today..

Unusually touchy feely from you. I think we overall expect and anticipate improving procedure trends on a global basis. We've seen it opening up in the US, as Matt just said, the EMUs are putting patients through a little more proactively. International is opening up. So, I think, overall, I'd say procedure trends are looking positive.

I think the macro factors are going to continue to remain challenging that the supply chain, inflation, foreign exchange. We won't guide until the fourth quarter earnings call in February. But the trend in the NPIs is progressing well in US epilepsy.

And we know that that's an important factor for us, that heart lung machines and rest of the world continue to track well. And even though we're launching Essenz, the rest of world, most of those markets don't come online for Essenz until 2025, 2026. So, seeing the continued growth of HLMs there is important.

And procedure volumes around oxygenators continue to be key for us. I'd say looking at the consensus for 2023, though, I don't believe people have fully factored in the foreign exchange impact on the current rates..

Maybe you could expand on just that last point..

It's Alex. I can take that one. Just looking at sort of the timing of when the FX really started to trend in the wrong direction for us, in terms of sort of the estimates, we see a potential of $0.05 to $0.10 EPS impact In terms of the negative FX..

Our next question comes from Mike Polark of Wolfe Research..

I'm curious on the Essenz launch, next gen HLM. If you said anything, I missed it. I didn't hear anything in the prepared remarks about any updated thoughts there. Obviously, building a lot of products ahead of that, I presume. And the supply chain is tricky. So still on track there.

Any kind of challenges to call out that you're navigating? And can you just remind us on what's happening now in the second half, in the fourth quarter and what you expect to happen next year?.

On Essenz, that programs progressing well, too. We're moving through all of our verification and validation steps. We still expect the first clinical cases to occur before year-end. That will be in Europe.

And in terms of supply chain, we're actually pretty confident about the material for the first units, both through the clinical cases and then the limited commercial release. So, I think that's progressing well. We then will expand into the US in the new year after the European expansion. .

The follow-up on ACS, understand the kind of evolving case mix dynamics, looking at the revenue sequentially, down a bit, but round numbers kind of in the $9 million a quarter range.

Can you describe your level of confidence or conviction that this is kind of the – at or near the troughs and, from here, a growth pattern can be restored?.

It's Matt. When you look at the third quarter, Damien highlighted, we were down 44%. We think, based on third-party data, the market was down 30%. So, we were down a little more this quarter. Remember last year, we said COVID was 40% of the procedures in the third quarter of 2021. That's down all the way down to 5% this quarter.

So that was obviously huge impact. And non-COVID was up over 20%. So we caught some up. I would say the other couple of things that impacted the quarter, the issue we had with the reclassification that came at the end of the quarter, but the sales force was dealing with it because we put the letter out in July. So, there was a modest impact from that.

And then, I'd say, finally, there's been some additional competition on the cannula side that's impacted us a little bit. So those are some small pieces. For the fourth quarter, we do expect probably a modest improvement. We're not factoring any benefit from flu. That could be upside, but we're not factoring that in.

But the FDA classification again came out at the end of the quarter. There'll probably be some impact from that in the fourth quarter. We anniversary the COVID impacts really at the end of the first quarter of 2023. So, after that, we expect to see the growth pick up a more meaningful amount..

Our next question comes from Matt Taylor of Jefferies. .

I just wanted to ask a question about the RECOVER study and the next interim look. And I guess maybe you could offer some thoughts about why we haven't seen the curves separate or that statistical analysis results in a conversion yet versus what you might have thought six or nine months ago..

Matt, at 375, just based on the trial design, there has to be some separation. What's occurred is we haven't had enough separation to stop early. But, overall, when you look at, the trial was designed to run at the full 500 patients and still hit the statistical significance.

For stopping early, the original paper did suggest that there were odds of this, but we've always assumed it would occur later in the year. Overall, we still think there's a very good chance we stop early. And again, we have very high confidence that, even if we have to go the full 500, that we will hit statistical significance..

Just a clarification, what happens after 500?.

If we don't stop early, we would essentially have to run the full 500 12 months. So, that would be the main difference. At this point in time, we're not certain that we would be allowed to shift to a registry, but that's not clear..

Our next question comes from Mike Matson of Needham. .

I guess I'll start with the ACS business.

Just given the headwinds there and the decline that we're seeing, are we at risk of seeing some turnover in the sales force? Are you doing anything to try to retain the reps there?.

We've done a lot of work to make sure that that team is intact. The non-COVID business is actually progressing rather well. It's up 20% year-on-year. So we're very pleased with that progression. It's not like their activity has disappeared. The cardiac and the non-COVID respiratory cases are still very much in focus.

We have made changes to that business to face the reality of the new the new market. So, we've taken out headcount in non-commercial spaces. We've recently replaced the leader of that business. And I'm looking forward to that business getting back to double-digit growth in the new year..

Your SG&A and R&D – or I guess, OpEx overall was up a fair bit. And I heard Alex's explanation was that it was lower last year, but I guess, conversely, it was higher this year.

So, why was it so much lower last year or so much higher this year?.

If you recall last year, we were sort of heading into the Omicron stage of the pandemic. And we were seeing some softness in our business throughout Q3. And we basically deferred spending into Q4. So if you look, it's really just the phasing and timing of spending..

Mike, we did highlight that last year. On the question of, when we hit the third quarter, we did say some of the third quarter expense will move into Q4 at that point..

As far as sleep apnea goes with OSPREY, so if you're submitting the data, I think you said you expect to submit it late next year.

At what point would we see the data, when data be made public? Or would it not happen till after the FDA reviews it?.

Because it's a pivotal, it would have to be in line with the FDA approving and then finding a venue for that at the appropriate sleep apnea conference. .

Our next question comes from Adam Maeder of Piper Sandler. .

Wanted to start with just Neuromod and was hoping to flesh that performance out a little bit more. Good performance in the US and rest of world. But was hoping to put a finer point NPIs versus replacements in Q3 and kind of exactly what those figures look like.

And then how do we think about NPIs versus replacements in Q4? And then I had a follow up?.

End-of-service outpaced NPIs, as Matt said. They grew low-double digit year-on-year and above the 2019 levels, which was important. NPIs were roughly flat year-on-year. They're still below 2019. But importantly, they grew sequentially. They were up about 8% for the quarter.

And that for us was an important step, and I think the best NPI performance year-on-year for this year, year-to-date. So, the progression there as well, again, the CEC pods are the ones that are performing well there and above the baseline. So, overall, I continue to expect the NPIs to improve sequentially.

We think replacements will improve sequentially. And that's why we've been more confident about what the full year looks like for total epilepsy..

For the follow-up, I'll ask about the heart failure program and ANTHEM pivotal trial. Sounds like we're still on track to get another look at the data in Q4 of this year. What are the expectations for this look? Do you expect the interim analysis to be to be positive? Just maybe level set us there. And then any color on pathway forward..

That's progressing well. That team is executing with their implant rate. The expectation is that we hit the 500th patient somewhere, mid to late Q4 we'll have the data. The analysis here is that is a longer step up than the depression studies, so take the six to eight weeks. So, in January, we'd expect to have the results.

What we're looking for here is the nine months – you've got to hit five green lights. So, the nine month safety data, the primary endpoint, advancing on the composite mortality and morbidity, and the functional endpoints, which left ventricular ejection fraction, six minute walk and quality of life.

We don't know which of the five – if you did get a red light, you don't know which of the five is the red light. But we're, again, very confident about safety given we've been part of over 125,000 of these. So, it's really the other four that we're looking for green lights at this time. But we can't handicap that in any way..

And our final question of today comes from Amit Hazan..

A few follow-ups, if I could. The first one was, the 2023 FX comment sounded specific to EPS.

From a sales perspective, does it seem like numbers are being contemplated properly? Is it kind of in the 250 basis points to 300 basis points headwind range right now from what you guys are looking at?.

It's probably a bit higher, Phil. Again, we're sort of lapping, I'd say, the first half of the year, which was probably less impacted by FX. .

Flipping back to the RECOVER trial, interested kind of more qualitatively what the implication is of the trial running a little bit longer before early completion versus what you've kind of messaged previously in that 325 to 375 range.

So I guess the question is, if statistical significance is reached, at any point, is that really what you guys are focused on? Or do you think there's a qualitative element to this that's going to be important, down the road as commercialization becomes more and more in focus?.

A couple of things on that. In terms of where we are in the trial versus the original trial design, because of COVID, where we are in the average follow-up number of patients that have reached 12 months, we're still a little bit behind at this stage of 375, where we thought we would be in the in the original design. That impacts the statistical power.

I think the second thing is what we're focused on here for stopping early is an endpoint called time in response. And it's unique in depression trials because you usually don't have trials going on this long.

So, you can't look at time in response and the different percentages between a control arm and a therapy arm versus other depression trials because nobody else has used that. So, we still think that the spread or the difference between the two arms can be very powerful.

And any of the three scenarios we laid out, overall, you need to see the full data set, ultimately, to, I think, better compare it to other depression trials..

Even though we're at 375 or approaching 400, the number of patient months accrued is a little bit lower than what you would have anticipated previously because of the impacts of COVID and it sounds like there's still some – definitely feel like the potential for the powering of this study, if successful, is still there with some confounding factors through the last couple of years?.

That and the number of patients that are at 12 months completion – they're called completers as the PIs call it, so both the numbers are still slightly behind. And again, I think it's important, the paper was studied – powered to run to 500 patients.

The early stop was really about patients being on a sham controlled arm with a device that's already approved. The greatest statistical success of the program was empowered for 500 patients..

Thank you. At this time, we have no further questions, so I'll hand back over to Damien MacDonald for any closing remarks..

Thank you, Charlie. And thank you for everyone joining the call today. And on behalf of the entire team, we appreciate your support and interest in LivaNova and we look forward to updating you on the Q4 results in the new year. Cheers. Bye..

Ladies and gentlemen, this concludes today's call. Thank you for joining. And you may now disconnect your lines..