LivaNova PLC (NASDAQ:LIVN) Q4 2023 Earnings Call Transcript

LivaNova PLC (NASDAQ:LIVN) Q4 2023 Earnings Call Transcript February 21, 2024

LivaNova PLC beats earnings expectations. Reported EPS is $0.87, expectations were $0.79. LIVN isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: 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.

Matthew Dodds: 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.

A – William Cozy: 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 our prior disclosures. I must extend sincere appreciation to our LivaNova colleagues around the world who responded with urgency and extraordinary dedication. Thank you. For the remainder of the call, I’ll discuss our fourth quarter and full year results, and then turn to our strategic portfolio initiatives. After my comments, Alex will provide additional details on our results and 2024 guidance. I’ll wrap up with some closing remarks before moving on to Q&A. In the quarter, we achieved 12% revenue growth versus the prior year.

This performance was driven by the cardiopulmonary and neuromodulation businesses with particular strength in the Europe and U.S. regions. On a full year basis, we achieved 13% revenue growth versus the prior year marked by double-digit growth across all regions. Notably, we delivered on our commitment to modest leverage, achieving 17% growth in both adjusted operating income and adjusted diluted earnings per share. Now turning to segment results, for the cardiopulmonary segment, revenue was $162 million in the quarter, an increase of 17% versus the fourth quarter of 2022. Heart lung machine revenue increased more than 40% primarily driven by Essenz sales in the Europe and U.S. regions. We were pleased to see a meaningful sequential ramp in Essenz sales during the quarter with strong placements, and pricing execution.

Oxygenator revenue grew in the mid-single-digits driven by customer demand and price. As previously noted, the oxygenator business faces capacity constraints, and the team made significant efforts in the quarter to mitigate the disruption from the cybersecurity incident, including working additional shifts on weekends and holidays. Cardiopulmonary revenue for the full year was $589 million and grew 18%. We expect cardiopulmonary revenue to grow 6% to 7% for full year 2024. Our forecast incorporates strong HLM growth, which will be offset by slower growth in disposables due to the current capacity constraints. Our recent efforts to expand oxygenator capacity are now expected to provide some benefit in the second half of the year. Epilepsy revenue increased 8% versus the fourth quarter of 2022.

The U.S. epilepsy revenue increased 8% year-over-year, with growth in both new and replacement implants. We achieved 856 new patient implants in the quarter representing 6% growth versus the prior year. We realized why 1982 replacement implants representing 10% growth versus the prior year, an unusually high growth rate. Epilepsy revenue in Europe and the rest of the world grew 7% versus prior year. For the full year, epilepsy revenue increased 10%. Notably, U.S. epilepsy achieved 3300 new patient implants in the full year, representing 7% growth versus the prior year. Replacement implants reached 7608 for the full year, also a 7% increase, which was higher than expected. For the full year 2024, we expect global epilepsy revenue to grow 6% to 7%.

Our forecast incorporates a continued mid-single-digit growth for U.S. new patients, and more normalized low-single-digit growth in replacements. ACS revenue was $10 million in the quarter, an increase of 5% versus the fourth quarter of 2022. ACS revenue for the full year was $40 million and grew 3%. As previously noted, the wind down in the ACS segment is anticipated to be substantially complete by the end of 2024. Alex will comment on the financial impact of the ACS wind down later in the call. DTD revenue for the fourth quarter was $2 million, and for the full year was $7 million. For 2024 we anticipate DTD revenue of approximately $7 million primarily from the Recover Study. The Recover Study does continue. As a reminder enrollment for the Unipolar cohort of this study has been completed.

We anticipate the receipt of the 12 month follow up data for the 500 Unipolar patients in June of 2024, after which we will conduct a final analysis. We continue to expect the publication of the study results by late 2024. The bipolar cohort continues to enroll as expected. Moving to OSA, the OSPREY trial continues to progress with all 25 study sites recruiting patients. In heart failure, the closeout of the ANTHEM clinical study is substantially complete. Overall R&D spend related to heart failure in 2023 was $25 million, the majority of which occurred in the first half of the year. With that, I’ll turn the call over to Alex.

Alex Shvartsburg: 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. Adjusted operating income margin was 16% compared to 17% in the fourth quarter of 2022. The cybersecurity incident negatively impacted adjusted operating income margin by approximately 100 basis points due to disruption to our cardiopulmonary manufacturing sites. Adjusted effective tax rate in the quarter was negative 3% and in line with the fourth quarter of 2022. The tax rate was impacted by the release of the evaluation allowance. Adjusted diluted earnings per share was $0.87, compared to $0.81 in the fourth quarter of 2022.

Our cash balance at December 31st was $267 million, up from $214 million at year-end 2022. Total debt at year-end 2023 was $587 million, up from $542 million at year-end 2022. The increase in total debt was driven by the delays drawn of $50 million on the term loan facility that we put in place in July 2022. Net that including restricted cash at year-end was $48 million. Adjusted free cash flow for the quarter was $60 million, up from $31 million in the prior year period. The year-over-year increase was driven mostly by higher income and improvements in working capital. Capital spend was $35 million in 2023, compared to $27 million in the prior year. The increase was driven by IT systems and cardiopulmonary manufacturing infrastructure investments.

In connection with the cybersecurity incident, the company incurred costs of approximately $2.6 million in the fourth quarter, which are excluded from our adjusted operational results. These costs primarily included external cybersecurity experts, legal counsel, and system restoration costs. We continue to monitor developments of the ongoing investigation and may incur additional costs related to this incident. With respect to the wind down of the ACS, business and transition of certain products into cardiopulmonary, we recorded a pretax non-cash impairment charge of $103 million during the fourth quarter, which is excluded from our adjusted operational results. We expect to incur additional restructuring charges in the range of approximately $15 million to $20 million, the majority of which will be recognized and paid in 2024.

Also effective in the first quarter of 2024, we are reorganizing our operating and reporting structure from three to two segments; cardiopulmonary and neuromodulation. The ACS, standalone cannula and accessories will be included within the cardiopulmonary reportable segment. The remaining ATS business will be included within other. Now turning to 2024 guidance, we forecast 2024 revenue growth on a constant currency basis between 4% and 5% and between 6% and 7%, when excluding the portion of the ACS business that we will be exiting. Foreign currency is expected to be negligible based on the current exchange rates. We expect the wind down of the ACS business to result in a positive contribution to adjusted operating income in 2024 as compared to 2023, with an impact of approximately $0.10 in EPS.

With the closeout of the ANTHEM clinical study substantially complete, we expect the reduction in R&D spend related to the heart failure program to result in a positive contribution to adjusted operating income in 2024 as compared to 2023 with an impact of approximately $0.35 in EPS. The global tax landscape continues to evolve and will impact our adjusted effective tax rate in 2024. We anticipate a full year adjusted effective tax rate of approximately 21%. Applying this rate to 2023 earnings results in an unfavorable impact of approximately $0.45 in EPS. We are projecting adjusted diluted earnings per share in the range of $2.95 and $3.05 with adjusted diluted weighted average shares outstanding to be approximately 55 million for the full year.

Despite the unfavorable impact caused by the step up in our adjusted effective tax rate, the CPS range represents growth of 7% at midpoint. We recognize that there are a number of moving parts in our 2024 EPS guidance. To be clear, the step up in our effective tax rate will have an unfavorable impact on our EPS results. However, our portfolio optimization actions, including the wind down of the ACS segment and the heart failure program, enable us to manage this impact. Adjusted free cash flow is expected to be in the range of $95 million to $115 million, an increase of approximately 9% at midpoint versus the prior year. This range includes a meaningful step up in capital spending, which we forecast to be approximately $60 million. This increase is driven by critical investments to support innovation, growth, and infrastructure.

In addition, our cash flow projections include the costs associated with the ACS wind down. In summary, I’m encouraged by the company’s execution and financial performance in 2023, which included double-digit revenue growth along with a 50 basis point of operating margin improvement. Since 2023 performance was achieved while investing in critical capabilities for the company, including manufacturing infrastructure, and IT modernization, as well as managing the impact of our business operation as a result of the cybersecurity incident. These actions position us well for 2024. Our guidance implies adjusted operating income growth of approximately 25%, an improvement of 300 basis points in adjusted operating income margin. Excluding both heart failure and ACS benefits, adjusted operating income growth would have been 10%.

This builds upon our consistent three-year trend of operating leverage improvement with 14% operating margin 2022, 15% in 2023, and a commitment to achieving greater than 17% in 2024. And with that, I’ll turn the call back over to Bill.

William Cozy: 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.

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Q&A Session

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

Rick Wise: 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.

Matthew Dodds: 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.

William Cozy: 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.

Rick Wise: 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.

William Cozy: 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.

Rick Wise: Great, thank you.

Matthew Dodds: Hey, thanks, Rick.

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

Anthony Petrone: 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.

William Cozy: 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.

Anthony Petrone: 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.

Alex Shvartsburg: 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.