LivaNova - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 revenue rose to $321.8M (+3.8% reported, +4.7% cc; +6.8% organic), driven by cardiopulmonary strength; GAAP diluted EPS was $1.02 and adjusted EPS was $0.81, with the adjusted EPS decline vs prior year primarily due to a higher effective tax rate.
• Cardiopulmonary grew 9.9% reported (+11.2% cc) on consumables demand and Essenz placements; Neuromodulation was +0.5% reported (+1.0% cc), with U.S. growth offset by Europe/ROW declines.
• 2025 guidance initiated: revenue +5–6% cc (+6–7% organic), adjusted EPS $3.65–$3.75, adjusted FCF $135–$155M, FX headwind 1.5–2.0%, adjusted tax rate ~24% and capex ~$90M; segment outlooks: CP +7–8%, epilepsy +4–5%.
• OSPREY randomized OSA study met primary endpoints; median AHI fell 66% and ODI fell 63% at 6 months; PMA submission targeted 1H25, with a limited launch ahead of full launch (MRI compatibility planned).
• Watch catalysts: OSPREY 12‑month outcomes (Q2 2025), PMA submission (1H25), SNIA litigation ruling (H1 2025; potential ~$0.11 quarterly EPS impact if adverse), and continued Essenz penetration/pricing leverage.

What Went Well and What Went Wrong

What Went Well

• Cardiopulmonary delivered double-digit growth; management highlighted sequential HLM (Essenz) strength and oxygenator demand with price/mix tailwinds: “We were pleased to see a sequential increase in Essenz revenue… Oxygenator revenue grew in the mid-teens, driven by customer demand and price”.
• Non-GAAP operating leverage improved; adjusted operating income margin rose to 17% (from 16% in Q4’23) on revenue growth and wind-down of ACS and heart failure programs.
• OSPREY met efficacy and safety endpoints, with strong 6‑month reductions in AHI (−66%) and ODI (−63%); management reiterated PMA submission in 1H25.

What Went Wrong

• Neuromodulation (epilepsy) outside the U.S. declined a combined 9% YoY; management cited isolated personnel/execution issues, though actions were taken and growth is expected to return in 2025.
• Adjusted EPS fell YoY to $0.81 (vs $0.87) largely due to a higher adjusted effective tax rate (~20% vs negative 3% prior year), reducing EPS by ~$0.19.
• “Other Revenue” (residual ACS and site services) declined 67.8% YoY in Q4, reflecting ACS wind-down; organic net revenue excludes ACS.

Transcript

Operator (participant)

Good day, ladies and gentlemen, and welcome to the LivaNova PLC Fourth Quarter and Full Year 2024 Annual Conference Call. As a reminder, this conference call is being recorded. I'd now like to introduce your host for today's conference, Ms. Briana Gotlin, LivaNova's Vice President of Investor Relations. Please go ahead.

Briana Gotlin (VP of Investor Relations)

Thank you, and welcome to our conference call and webcast discussing LivaNova's financial results for the Fourth Quarter and Full Year of 2024. Joining me on today's call are Vladimir Makatsaria, our Chief Executive Officer and member of the Board of Directors, Alex Shvartsburg, our Chief Financial Officer, Ahmet Tezel, our Chief Innovation Officer, and Zach Glazier, 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 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 revenue results, which will be stated on a constant currency and organic 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 Investor section of our website under News, Events, and Presentations at investor.livanova.com. With that, I'll turn the call over to Vlad.

Vladimir Makatsaria (CEO)

Thank you, Briana, and thank you, everyone, for joining us today. Welcome to LivaNova's conference call for the Fourth Quarter and Full Year of 2024. The year was marked by strong financial results, significant innovation milestones, and a meaningful transformation of talent and culture. We delivered 11% organic revenue growth in 2024, our second consecutive year of double-digit organic growth. We also expanded operating margins and increased free cash flow. We are pleased with these results and the execution that made them possible. Additionally, we're encouraged by the clinical milestones achieved in obstructive sleep apnea, difficult-to-treat depression, and the three-year results from the largest real-world evidence study of VNS therapy for epilepsy called CORE VNS. In obstructive sleep apnea, or OSA, the OSPREY clinical study met its primary efficacy and safety endpoints. This achievement unlocks a strategic growth opportunity for LivaNova.

We plan to bring this technology to market, and in doing so, we will leverage and extend the vast clinical and scientific expertise of our neuromodulation business to a new therapeutic area. We will increase investment in order to accelerate product development and ensure a competitive and differentiated product portfolio. With growing worldwide prevalence and improved diagnosis for OSA, we expect the hypoglossal nerve stimulation market to approach $2 billion by the end of the decade, with plenty of room for treatment alternatives. Based on these factors, combined with strong OSPREY clinical data, we are confident this program will generate value for LivaNova, and I'm excited by the opportunity to impact more patient lives. In difficult-to-treat depression, or DTD, we continue our pursuit of CMS coverage. Five critical publications will support our position, two of which were already published in December.

A positive reimbursement decision would represent a meaningful opportunity for critically ill patients with DTD while further diversifying our portfolio. Finally, and importantly, in 2024, LivaNova embarks on a transformative journey to strengthen our talent and culture, with a clear focus on innovation and a growth mindset. To accelerate our future progress, we have prioritized attracting industry-leading professionals while developing and promoting top talent from within. Over the past year, approximately 30% of our overall director-level and above positions have been filled by new hires or internal promotions, bringing fresh perspectives and expertise to drive our next phase of growth. We have also enhanced our executive leadership team with five new leaders. Most recently, we welcomed Natalia Kuzmina as our Chief Human Resources Officer.

With more than 25 years of global experience in medtech and pharmaceuticals, Natalia is a proven leader who will play a pivotal role in shaping our talent strategy. I'm excited to partner with her and the entire executive leadership team as we continue building a high-performing, innovative organization poised for the future. For the remainder of the call, I will discuss our results and top-line guidance for Full Year 2025. After my comments, Ahmet will discuss our innovation pipeline. Alex will then provide additional details on our results and 2025 guidance. I will wrap up with closing remarks before moving on to Q&A. In the quarter, we achieved 5% revenue growth and 7% organic growth versus the prior year. On a full-year basis, we achieved 9% revenue growth and 11% organic growth versus the prior year, driven by the strength in both the cardiopulmonary and epilepsy businesses.

Notably, we achieved 41% growth in adjusted operating income and 21% growth in adjusted diluting earnings per share. I want to acknowledge the entire organization for their dedication to enhancing our cash generation. Our progress was evident in our strong free cash flow performance, delivering $163 million in adjusted free cash flow for the full year 2024. Now, turning to segment results. For the Cardiopulmonary segment, revenue was $182 million in the quarter, an increase of 11% versus the fourth quarter of 2023. Heart-lung machine revenue grew in the mid-single digits despite the difficult year-over-year comparison. As a reminder, the HLM business grew more than 40% in the fourth quarter of 2023 due to accelerated Essenz placements following approval of the inline blood monitor. In the fourth quarter of 2024, we were pleased to see a sequential increase in Essenz revenue and continued strong price mix.

As a point of reference, Essenz represented approximately 40% of our annual HLM units placed in 2024. Oxygenator revenue grew in the mid-teens, driven by customer demand and price. We successfully exited a year with approximately 10% increase in manufacturing capacity, and we continue to see global demand outpace supply. Cardiopulmonary revenue for the full year was $684 million and grew 14%. We expect cardiopulmonary revenue to grow 7%-8% for the full year 2025. Our forecast incorporates continued HLM growth as we launch Essenz in new markets and continue to increase penetration in existing markets. We expect Essenz to represent approximately 60% of our annual HLM units placed in 2025, while maintaining a price premium. Our forecast also reflects continuing strong demand for consumables and expanded manufacturing capacity. We believe there are opportunities to further accelerate growth in Essenz and to continue to grow market share in consumables.

We are working diligently to expand oxygenator manufacturing capacity beyond the level built into guidance. Turning to epilepsy, revenue increased 1% versus the fourth quarter of 2023. U.S. epilepsy revenue increased 4% year-over-year, driven by product mix, price, and total implants. We achieved approximately 1% growth in both new patient and replacement implants versus the prior year. Epilepsy revenue in Europe and the rest of the world declined a combined 9% versus the prior year. We have taken measures to improve commercial execution and have confidence in the future growth of this business. For the full year, epilepsy revenue grew 7%. U.S. epilepsy revenue grew 8% and achieved 5% growth in both new patient and replacement implants versus the prior year.

Epilepsy revenue in Europe and the rest of the world grew a combined 2% versus 2023, with double-digit growth in the rest of the world offset by decline in Europe. For the full year 2025, we expect global epilepsy revenue to grow 4%-5%. Our forecast incorporates a continued mid-single-digit growth rate for U.S. new patient implants. We expect U.S. replacement units to be flat due to the decline in total implants that occurred in 2019 and 2020. Our forecast also assumes that the rest of the world and Europe regions return to a combined high single-digit growth rate in 2025. We will continue our efforts focused on narrowing the drug-resistant epilepsy treatment gap and driving growth in surgical therapies for the significantly underpenetrated patient population.

In summary, our growth in 2024 was driven by healthy markets, the successful rollout of Essenz, market share gains in cardiopulmonary consumables, and pricing strategies. These drivers will continue to fuel our growth in 2025. As a result, we are guiding full year 2025 organic revenue growth between 6% and 7%. Alex will provide additional details on our 2025 guidance later in the call. With that, I'll turn the call over to Ahmet to discuss our innovation pipeline.

Ahmet Tezel (Chief Innovation Officer)

Thank you, Vlad. Innovation is a key focus area for LivaNova and one of our growth drivers as we look to the future. Our R&D organization is focused on enhancing our core portfolio while also advancing our difficult-to-treat depression and obstructive sleep apnea programs. We are pleased with the progress we made in 2024 across our entire portfolio. In CP, we continue to make progress in developing a next-generation oxygenator and enhancing capabilities for Essenz, such as adding advanced inline blood monitoring. This is designed to guide the perfusionist during the procedure to further optimize patient-tailored outcomes. We're also working on various product upgrades throughout the CP portfolio. For example, we are pleased to announce the commercial launch of ProTek Duo Plus in the U.S. and Canada, with the approval for use in ECMO procedures. This is our first dual-lumen cannula to carry this ECMO indication within the U.S.

The product further strengthens our full suite of CP solutions, and we expect this new offering to be a growth driver in 2025. In epilepsy, we're focusing on the next-generation system with cloud connectivity and driving clinical evidence initiatives for VNS Therapy. In December, we shared interim data from our CORE VNS study at the American Epilepsy Society, or AES. This is the largest global long-term contemporary registry of VNS Therapy in LivaNova's history. At AES, we presented preliminary conclusions from seven posters covering a wide variety of subjects from this data set, including one examining long-term outcomes in patients with generalized tonic-clonic seizures with VNS Therapy. The data show that VNS Therapy reduced the frequency of generalized tonic-clonic seizures with a responder rate of 70% and median seizure frequency reduction of 83% at 36 months.

We expect a number of publications from the core data set throughout 2025, the first of which was published in Epilepsia earlier this month. The authors concluded that the results from the core study support VNS as a compelling therapy in drug-resistant epilepsy associated with Lennox-Gastaut syndrome. In OSA, the OSPREY clinical study met its primary efficacy and safety endpoints. As a reminder, OSPREY is the first and only randomized controlled trial for hypoglossal nerve stimulation therapy to support a U.S. regulatory approval to date. The patients in OSPREY are also the most severe ever studied in a U.S. pivotal trial. These patients had a higher baseline mean BMI, in addition to higher median Apnea-Hypopnea Index and higher Oxygen Desaturation Index compared to other pivotal U.S. trials.

Based on these trial characteristics and OSPREY's six-month clinical outcomes, we're confident that our clinical data set is competitive with the current standard of care. When comparing median values from baseline to just six months of therapy, OSPREY subjects in the active group demonstrated a 66.2% reduction in AHI and a 63.3% reduction in ODI. We are very pleased with these six-month outcomes, particularly the rapid onset of therapy with OSPREY. We're excited to share the 12-month outcomes when they become available in the second quarter. We still expect to complete the PMA submission in the first half of 2025. As Vlad mentioned, we're accelerating investment in the OSA product development to deliver a competitive and differentiated product portfolio. In Difficult-to-Treat Depression, two publications were published in December, and the remaining three were submitted.

The articles highlight a significant unmet need of severely ill Medicare beneficiaries with treatment-resistant depression, or TRD, with limited treatment alternatives. The RECOVER data demonstrates that VNS therapy improves symptoms, function, and quality of life in TRD patients over time. These are outcome measures identified as clinically relevant by CMS. Symptoms, function, and quality of life taken together present a more complete picture of treatment effectiveness than symptoms alone. All pre-specified RECOVER endpoints favored active VNS therapy, and the totality of evidence supports our pursuit of Medicare coverage for VNS therapy for TRD patients with high unmet treatment needs. As we have done throughout the RECOVER program, we continue to partner with CMS and inform the agency of our progress. We're working towards a formal request for coverage once all five critical manuscripts are published.

This will be a formal reconsideration submission per the guidelines of the CMS national coverage determination process. In summary, we're encouraged by our progress in core innovation as well as in the OSA and difficult-to-treat depression programs. Looking ahead, we will continue to improve R&D efficiency and our cadence of innovation enabled by our new operating model and governance process. As a result, over time, our investment in R&D as a percentage of revenue should decrease to align with the industry benchmark. With that, I will turn the call over to Alex.

Alex Shvartsburg (CFO)

Thanks, Ahmet. During my portion of the call, I'll share a brief recap of the Fourth Quarter results and provide commentary on 2025 guidance. Turning to results, revenue in the quarter was $322 million, an increase of 5% on a constant currency basis and 7% on an organic basis versus 2023. Foreign exchange in the quarter had an unfavorable year-over-year impact of approximately $3 million, or 1%. Adjusted gross margin as a percent of net revenue was 69% compared to 68% in the Fourth Quarter of 2023. This year-over-year increase was driven by favorable product mix and pricing. As a reminder, Fourth Quarter 2023 gross margin was negatively impacted by costs associated with the cybersecurity incident. Adjusted R&D expense in the Fourth Quarter was $40 million compared to $42 million in the Fourth Quarter of 2023.

R&D as a percent of net revenue was 13%, down from 14% in the Fourth Quarter of 2023. The year-over-year decrease was largely driven by the closeout of the heart failure trial and the wind down of the ACS segment. Adjusted SG&A expense for the Fourth Quarter was $127 million compared to $120 million in the Fourth Quarter of 2023. SG&A as a percent of net revenue was 40% as compared to 39% in the Fourth Quarter of 2023. The year-over-year increase was driven by commercial activities to support growth, as well as investments to enable infrastructure for scalability. Adjusted operating income was $56 million compared to $48 million in the Fourth Quarter of 2023. Adjusted operating income margin was 17% compared to 16% in the Fourth Quarter of 2023.

This increase was primarily driven by higher revenue, improved operating leverage, and the wind downs of the heart failure program and the ACS segment. Adjusted effective tax rate in the quarter was 20% compared to negative 3% in the Fourth Quarter of 2023. The increase is related to developments in the global tax landscape. The negative tax rate in the prior year period was impacted by the release of a valuation allowance. Adjusted diluted earnings per share was $0.81 compared to $0.87 in the Fourth Quarter of 2023. The decrease was primarily driven by the higher effective tax rate, which was a $0.19 unfavorable impact to EPS. Our cash balance at December 31st was $429 million, up from $267 million at year-end 2023. Total debt at year-end 2024 was $628 million, up from $587 million at year-end 2023.

This increase in total debt was driven by the closing of a $345 million private offering of convertible senior notes maturing in 2029, and repurchase of the $230 million of convertible senior notes, which mature in 2025. Adjusted free cash flow for the quarter was $62 million, up from $61 million in the prior year period. The year-over-year increase was primarily driven by stronger operating results and working capital improvements. Adjusted free cash flow for the full year 2024 was $163 million, up from $96 million in the prior year period, representing 70% growth. We saw a significant improvement in cash conversion during 2024. Capital spend was $47 million in 2024 compared to $35 million in the prior year period. The year-over-year increase was driven by IT investments and cardiopulmonary capacity expansion initiatives.

Now, turning to our 2025 guidance, we forecast 2025 revenue growth between 5% and 6% on a constant currency basis and between 6% and 7% on an organic basis. The impact of foreign currency is expected to be a headwind of 1.5% to 2% based on current exchange rates. We forecast a full-year adjusted effective tax rate of approximately 24%, representing an increase of 300 basis points versus 2024. We project adjusted diluted earnings per share in the range of $3.65-$3.75, 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 and the increased investment to accelerate OSA and core product development, this EPS range represents growth of 9% at midpoint. Adjusted free cash flow is expected to be in the range of $135 million-$155 million.

This range includes $90 million in capital spending, a $43 million increase versus the prior year. This increase supports critical investments in IT infrastructure, innovation, and growth, including cardiopulmonary capacity expansion initiatives. Briefly, I would like to provide an update on the SNIA litigation. On February 26, 2025, the Italian Supreme Court will hold a public hearing in connection with the matter. While the company does not anticipate a decision at the hearing, we expect a ruling in the first half of 2025 in response to all of LivaNova's appeals and the counter-appeals submitted by the Italian public administrations. We look forward to the court's decision and will provide updates as they become available. Please note that our full-year 2025 guidance issued today does not include any potential impact of a SNIA ruling. I'd also like to call out that our guidance does not include tariff-related impacts.

While the global tariff dynamic is fluid, we expect the impact of tariffs to be immaterial based on what we understand today. In summary, the company's 2024 execution and financial performance were strong. We delivered double-digit organic revenue growth and more than 400 basis points of adjusted operating margin expansion. We also achieved a 20% increase in adjusted diluted earnings per share and a substantial improvement in cash generation. This performance was realized while investing in innovation and critical capabilities. Our 2025 guidance is balanced, and we are well-positioned to achieve another successful year. With that, I'll turn the call back over to Vlad.

Vladimir Makatsaria (CEO)

Thank you, Alex. In 2024, we delivered strong financial results, achieved significant pipeline milestones, and meaningfully strengthened our talented team and culture. I want to thank all our colleagues around the world for their dedication to serving customers and their patients. In 2025, we will focus on talent, innovation, growth, and operational excellence. With our solid financial foundation, clear portfolio strategy, and capable team, we're well-positioned to build on our momentum and drive value for all stakeholders in 2025 and beyond. With that, we're ready to open the call for questions.

Operator (participant)

Thank you. If you have a question at this time, please press the star then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press star then the number two. As we enter the Q&A session, please limit yourself to one question and one follow-up, and then return to the queue if you have additional follow-ups. Our first question today comes from Rick Wise with Stifel. Your line's open. Please go ahead.

Frederick Wise (Managing Director)

Good morning. How are you all? Thanks for taking the question. Just to start off, a ton of things to ask about here. I'm sort of debating which ones. Maybe let's talk about perhaps cardiopulmonary. Just help us better understand and think through the U.S. and EU cardiopulmonary performance of the quarter. I mean, you came in overall a little less than we had looked for, but you did better in rest of world. And you talked about it a little bit, Vlad, but I appreciate the comps and the Essenz upgrade, but issues as a driver, but help us just better understand where you are in that process, what happened in the quarter in sort of U.S. and Europe, and why you're so confident about the outlook for 2025. Thank you.

Alex Shvartsburg (CFO)

Hey, Rick. It's Alex. Look, we're actually very pleased with our performance in the quarter. As you mentioned, we did have a challenging comp with HLM. We grew HLM placements in Q4 of 2023 by 40%. So needless to say, it was a challenging comp. But we did see sequential growth in HLM placements versus Q3. So we're pleased with that. We continue to see strong demand for the consumables. We continue to see the market demand outpace supply. So we're still operating in a backorder situation. Our team has done a great job of expanding capacity. We exited the year growing our capacity at about 10%. We expect to continue to build our capacity in 2025. And we feel that we have some opportunities for continued growth and some upside.

So generally speaking, all of the levers that we expected in our cardiopulmonary business from a performance perspective played out as planned.

Frederick Wise (Managing Director)

Yeah. That's helpful, Alex. Thank you. And again, a lot of ways to go here, but let me focus on the innovation pipeline. I mean, I think you're speaking much more clearly about the importance of the innovation pipeline. And maybe a two-part question. One, help us just better understand, maybe you can quantify a little bit more, the impact of the launch of the new ECMO-related product, the implications or the incremental potential benefit in 2025 on revenues of that new product. And just what else should we expect from what are you asking for, Vlad, from the innovation team in 2025? What should we be expecting in terms of incremental products that could drive both volume, price, share, improved mix, margin, that kind of thing? Thank you very much.

Vladimir Makatsaria (CEO)

Rick, thank you for a great question. I'll start, and then I'll ask Ahmet to build on the question, but if I step back, innovation, like I said, is one of the four strategic imperatives or pillars for LivaNova, and if I unpack it a little bit, the first one is really to deliver on key milestones in our epilepsy and cardiopulmonary businesses. I feel we've built a very strong leadership team in research and development, but also in all the functions that support innovation. At the same time, we've improved on our processes, governance, culture. So driving milestone delivery in epilepsy and cardiopulmonary is number one. Number two is we have two important, I would say, market access milestones with FDA submission for OSA and with a CMS submission for DTD. Those are very important milestones for our future growth, and the team is executing versus that.

And then the third one is we continue to build innovation capabilities, including business development, so including external capabilities for innovation. And so maybe Ahmet, you can give a little bit more flavor.

Alex Shvartsburg (CFO)

Maybe I'll comment a little bit about some near-term programs that we are focused on. On the epilepsy side, our key strategy is to provide connected care. This year, we plan to submit for an FDA approval to initiate that process of ensuring that our VNS Therapy is cloud-connected. That's a big milestone that we're going to achieve this year. On the CP side, besides ProTek Duo Plus, we are actively working on our NextGen Oxygenator, which is in the kind of mid-life of product development. And we are doing continuous upgrades to Essenz because, as you know, it's a software-driven product that gives us a lot of flexibility to add new features. And we're also going to support it with auxiliary equipment that essentially works together with an HLM device.

So we have a few launches coming up that will support the HLM system, Essenz, with additional auxiliary equipment that supports it. So in both businesses, we have some near-term opportunities. And as Vlad mentioned in OSA, this is a big year for us. We're going to submit our PMA in the first half. And with depression, we are going to conclude our submission to CMS, hopefully in the coming months.

Then, Rick, [crosstalk] just to add, this is Brandon. So we expect the specialty cannula business to grow approximately 10%, and that's primarily driven by the launch of ProTek Duo Plus.

Frederick Wise (Managing Director)

Gotcha. Thank you so much.

Operator (participant)

Our next question comes from Michael Polark with Wolfe Research. Your line's open.

Michael Polark (Senior Equity Research Analyst)

Hey, good morning. I have a question about the sleep apnea assumptions and the guidance. How much are you spending to prep for that launch? What is the nature of that spend? Are you already at the point where you might be hiring a sales force? And is the timing such that a submission in the first part of this year sets the stage for a proper commercial launch in 2026?

Vladimir Makatsaria (CEO)

Good morning. So let me start with maybe just the strategic view on OSA, and then I will turn it over to Alex on the financials. Look, I think our strategy has been to continue the sustained momentum of growth in our core and then get into faster growth markets. And OSA and DTD are enabling us to do that. And our confidence in OSA has increased over time for a number of reasons. First, it's significant unmet need with 85% of patients still undiagnosed. And as a consequence, the market is growing fast, and we expect it to be, like I said, at $2 billion by the end of the decade and clearly space for new competitors to enter.

And what gives us the right to win, which is an important element of our strategy, is we're very pleased with our clinical data so far and confident in the 12-month results. And we believe our architecture of our technology is differentiated to give us competitive advantage to win in this marketplace. And then I'll turn it to Alex for the comments.

Alex Shvartsburg (CFO)

Yeah, Mike, from a spend perspective, in 2024, we invested $27 million behind OSA. It was largely to complete enrollment in the trial. We are expecting to invest an incremental $8 million in 2025. However, we are shifting our investments from clinical spend more into product development. As was mentioned, we're looking to drive a compelling portfolio as we prepare to launch. We'll talk in more detail about the long-range financial projections surrounding OSA at our investor day later this year.

Vladimir Makatsaria (CEO)

Maybe I'll just add a little bit about your timing question. So we are going to submit the PMA first off this year. Obviously, we can't predict review timelines, but usually a new PMA is about nine to 12 months with FDA if everything goes well. We anticipate it would, particularly due to the strength of the clinical data. And then we will do a limited commercial launch followed by a full commercial launch later because we're going to have a cadence of upgrades on the future set of the device.

Michael Polark (Senior Equity Research Analyst)

As a follow-up, I'd like to ask about OUS Epilepsy. Disappointed in the quarter, you called out execution issues. What is the nature of those issues and the guidance for 2025 embedded in acceleration? How confident are you that that business can return to growth? Thank you for taking the questions.

Alex Shvartsburg (CFO)

Yeah, Mike. Yeah, we had some personnel issues. They were isolated across different markets. I think we mentioned that on the previous quarter's call as well. We've taken action during the quarter to remediate, and we are confident in our ability to grow that business again. As you know, historically, we've grown our OUS business at high single, low double-digit levels, and we expect to get back to that level of growth in 2025 and moving forward.

Operator (participant)

Thank you. Our next question comes from Matthew Taylor with Jefferies. Your line's open. Please go ahead.

Matthew Taylor (Managing Director and Senior Equity Research Analyst)

Hi, good morning. Thanks for taking the question. I wanted to ask actually about revenue phasing or EPS phasing this year. Is there anything special to call out, especially with some of the volatility that we saw in the revenue trend in neuromod and CP? Maybe you could just help us understand how things like tough comps, etc., could play through the year in the two businesses.

Alex Shvartsburg (CFO)

Hey, Matt. No, there's really nothing from a phasing perspective. As normal, Q1 tends to be our lowest quarter, and then we kind of ramp up over the course of the year with Q4 being our highest revenue quarter. But nothing special in terms of revenue phasing. It's sort of consistent performance and growth.

Matthew Taylor (Managing Director and Senior Equity Research Analyst)

Great. And maybe I can ask a follow-up on sleep. I know you gave a lot of color there to Mike's question, but when are we going to hear more about your specific plans for either developing that? You've also talked about potentially partnering or trying to monetize that asset.

Vladimir Makatsaria (CEO)

Yeah. So Matt, thanks for the question. There will be a couple of important milestones throughout the year. So first of all, in quarter two, we will announce 12-month results of OSPREY's study. And I think that will be an important milestone from a clinical point of view for us. The next one would be the FDA submissions, which we plan to do before the end of quarter two. And then the third one is the investor day in quarter four, where we will lay out a full commercialization plan, execution plan, and provide long-term financial outlook.

Matthew Taylor (Managing Director and Senior Equity Research Analyst)

Okay. All right. Great. Thank you, Vlad.

Operator (participant)

Next question comes from David Rescott with Baird. Please go ahead.

David Rescott (Senior Research Analyst)

Oh, thanks for taking the questions. I wanted to ask first on SNIA. I heard the comments around a potential decision or a decision, at least in the first half of 2025. Do you have a sense once that comes out around the timing of which, if you have to make that payout, when that timing would be? Is that something that would also happen in the first half of 2025? Does it come in the second half of 2025? And then I guess, do you have any further visibility onto maybe the thoughts around structuring kind of a payout over subsequent quarters?

Alex Shvartsburg (CFO)

Hey, David. Really, we expect this hearing to take place tomorrow, and we don't expect a decision. As I said, we do expect a decision sometime in the first half. It's nearly impossible for us to speculate on the decision, and hence, we're holding to the fact that there is no liability at this point in time, and hence, we haven't built that into our guidance. I think I've talked previously about the annualized impact on EPS if the ruling goes against us and it's in the quantum that was originally ruled by the lower courts, which was EUR 454 million. We've fine-tuned that given the latest interest rates and FX, and we estimate that the quarterly impact is around $0.11.

David Rescott (Senior Research Analyst)

Okay. Thank you. Maybe on the Epilepsy Neuromodulation business in 2025, I heard the comments there around a slower or, I guess, weaker replacement cycle from the 2020 weaker, I guess, down year in that segment from COVID, when you think about the potential impact there in 2025, I heard you called out 2019 and 2020 impacts on the replacement cycle for 2025. How much of that is baked or coming from that 2020 down year? And the question more so is, as you look into 2026, is there the potential for some of that weaker 2020 volumes to drag into 2026, or is a lot of this likely going to be in 2025 and therefore can be offset by some other segments or some other kind of new investment in the R&D pipeline as you get into 2026 and 2027? Thank you.

Vladimir Makatsaria (CEO)

Yeah, David, thank you. Let me start, and then I'll ask Alex to build on this, but to step back, DRE is still a massive opportunity for us, and the starting point there is, just in the U.S., there are over a million patients that are untreated today, and that number is even larger around the world, so the driving procedure penetration is a significant opportunity, and it's placed our strength because we are the market leader in this space, so our key focus is to increase new patient implantations through better commercial execution, through bringing innovation that Anna talked about, and we can unpack a bit more through working on market access, both from reimbursement and indication point of view, and through demonstrating clinical evidence of the VNS technology.

So all of that gives us confidence in continuing to improve the NPIs, which will be the main growth driver for us in 2025 and beyond.

Alex Shvartsburg (CFO)

Yeah. And then, David, to just follow up on your question around replacements. And we've been talking about this for a while now, but we are now lapping sort of down years in total implants in 2019 and 2020. And that's what we're factoring into our forecast for this year. So we expect replacements to be flat in 2025. And then we'll see how the year goes and what that looks like for 2026.

Operator (participant)

Our next question comes from Matt Miksic with Barclays. Your line's open.

Matt Miksic (Managing Director and Senior Equity Research Analyst)

Thanks so much for taking the question. So just one follow-up on the Epilepsy and the comments you made. You talked about 4%-5% for the full year and returning the OUS business to that kind of high single-digit range. Does that guide kind of assume that you get there by midyear? Any color in terms of the mechanics or the changes that you've made regionally or anything else you could add to that and then have one follow-up?

Vladimir Makatsaria (CEO)

Thanks, Matt. No, we believe it's going to be, as Alex said, it's going to be well-balanced throughout the year. We started seeing already at the end of last year good leading indicators in terms of the team and how they're executing, and so we expect kind of coming back to normalized growth and fixing those execution issues, not gradually, but well-balanced throughout the year.

Matt Miksic (Managing Director and Senior Equity Research Analyst)

Got it. So maybe exiting the year at that high single-digit level, OUS, but for the full year, more like balanced mid-single digits across the board. Is that fair?

Vladimir Makatsaria (CEO)

I would say mid-single digits across the board is the way we guide it. But specifically to Europe and some of the areas where we flagged execution issues and the rest of the world, we believe a return to high single-digit and low double-digit growth throughout the year.

Matt Miksic (Managing Director and Senior Equity Research Analyst)

Got it. Okay. And then just appreciate all the color on OSA. It's exciting, and looking forward to seeing the data and hearing about the strategy as it continues to develop. But on Cardiopulmonary, really strong continued growth there. You're investing in capacity. I remember the thinking was that this was somehow going to be kind of a temporary, almost like a temporary swell in the business, that over time you were kind of expecting or projecting, maybe not having the visibility a year ago or six months ago, that this might start to fade. But now it sounds like this might be a little more permanent or sustainable in the high single-digit range. Can you talk a little bit about that? Has there been kind of an increase in confidence or just more durable share gains there? Appreciate the color.

Vladimir Makatsaria (CEO)

Matt, thank you for the question. I think for me also joining about a year ago, this was a learning journey, both in terms of how we execute, but also about the market. And so you're right. I have significantly more confidence now in sustainability of that growth. And it starts really, it's about three dimensions for us. One is, actually four, and we talked about them. The procedure growth has been better than it was historically. And I think that's driven by the fact that maybe patients that are coming into in-hospital setting with cardiovascular disease are more advanced and are going to open heart surgeries. And there may be some other reasons behind it, but the market seems healthy. LivaNova, from my experience, is a real benchmark in pricing strategies, and that really helped us specifically in our disposables business.

We believe that price will continue to be a significant growth level for us. We talked about HLM. We're going from 40% Essenz placement versus all units placed in 2024 to 60%. And then in 2024, the price upgrade was about double Essenz versus the previous generation. So we believe that this upgrade from 40% to 60% will be a major driver. And the way you can think about it is the year after, it will be 80%, and then the year after will be close to 100%. So it gives us tailwind into the future. And then finally, and I think this is where most questions were, is our market share on the disposables. And over the past couple of years, we had a very strong run in terms of market share gains.

We estimate that we gained from low 30s to mid-30s in terms of share, and that trend continues throughout the year. I think one of the reasons that we've achieved market share gains was our ability to execute on capacity increases. And I want to bring a little bit of color to that. Last year, we were able to improve our manufacturing processes and increase shifts and drive 10% capacity increase. This year, it's going to be continuous improvement in our manufacturing processes, as well as bringing our key suppliers to an upgraded level of capacity supply for key components. So that gives us a path to 10%-15% capacity increase this year. We are guiding what's in the guide is 10% increase, but I think we have a path to 15% if our suppliers execute on their commitments.

Look, and then finally, 2026 and beyond, we are expanding our manufacturing footprint to make sure that we can deliver on this long term. So net, net, I think we are very well positioned to continue to gain market share. And you may follow some of the recent disruptions with one of the competitors. And I think we're well positioned to take advantage of that disruption as well.

Matt Miksic (Managing Director and Senior Equity Research Analyst)

Very helpful color. Thanks.

Operator (participant)

Our next question comes from David Roman with Goldman Sachs. Please go ahead.

David Roman (Managing Director)

Thank you. Good morning. I have one question just from a capital allocation standpoint and one maybe just to try to pull a lot of the moving parts here together in the quarter and the outlook. Maybe starting on the capital allocation side, Vlad, could you help us think about the decision-making process to invest in different parts of the business? And I guess when you look at the success you've had with the Essenz upgrade and some of the drivers within your core franchises, that's a significant return for you from both a strategic and financial perspective. And then if you look over to some of the pipeline initiatives, whether that's DTD or OSA, those continue to consume a significant amount of resources that look like it's very hard to see a scenario where those become return accretive over time.

So how do you think about investing in the core business, continuing to pursue these moonshot-type R&D initiatives versus utilizing some of that cash for external investment?

Vladimir Makatsaria (CEO)

Yeah. I'm just going to correct one word you used in your question. They're not moonshots anymore. And with that caveat, I'm going to start, and then I'll ask Alex to build on this. So you're absolutely right that number one foundation for our future growth today is continue to sustain growth in our core businesses in Epilepsy and Cardiopulmonary. And like I said, the four things that will drive our growth will be NPI and Epilepsy, upgrade to Essenz in Cardiopulmonary, gaining more share in Cardiopulmonary disposables, and our pricing. So this continues to drive our growth. And we have reinvested in our core to make sure that our innovation pipeline in the core and our commercial execution and our manufacturing capacity are well positioned to drive this growth in the future. OSA and DTD are important for us because they get us into the faster growth markets.

And in both areas, we've achieved significant milestones that de-risk our confidence in making this business successful and creating value for our shareholders. But if I look holistically in terms of R&D spend, for example, our R&D spend is, as percent of sales, is declining. We're proportionally spending more on our core businesses and less on OSA and DTD, driven by the fact that our clinical spend is going down. And so now we are on OSA specifically, we are more in the product development spend, and we feel very strong about our ability to win in this market. And maybe Alex, if you can bring more color.

Alex Shvartsburg (CFO)

Yeah. I just say that, first of all, we'll talk more about our capital allocation strategy during our Investor Day today. But just at a high level, right, we're looking at very large underserved markets that continue to grow, both OSA. DTD is an untapped opportunity. We feel like we have the opportunity to win in that space. The clinical evidence that we've generated through these studies is very compelling, right? And we believe that through science, we have the ability and opportunity to compete and win.

Vladimir Makatsaria (CEO)

Maybe I'll just add one comment. I want to emphasize something Vlad said. I'll be very quick. So our R&D spend percent of sales will continue to go towards the benchmark lower numbers, particularly because of what Vlad said. Our clinical spend are coming to an end for both OSA and depression that allows us to significantly reduce our R&D burn on those two elements.

David Roman (Managing Director)

Appreciate all the perspective. And maybe just to kind of just want to make sure that kind of I'm taking away here the key message from the quarter and the forward outlook. Obviously, 2024, excuse me, carried a period of elevated growth associated with the Essenz upgrades. And we've talked a lot about that. As we look to 2025, the 6%-7% organic growth, that reflects the continuation of above end-market growth. And then the earnings guidance that you've offered does include continued investment in OSA. So as I think about the base business, is it fair to think about 6%-7% top-line growth, almost double that on the bottom line when excluding some of the investment in these new growth initiatives?

I'm not asking you for an LRP, but just conceptually, is that a fair way to think about your top-line and bottom-line growth objectives on a go-forward basis, which is you have core growth in your existing franchises leveraged through the P&L that allows you to reinvest into some of these new initiatives, but still drive earnings growth ahead of the top line?

Alex Shvartsburg (CFO)

Yeah. That's right, David. So we'll unpack the components of our businesses and the P&Ls associated with them. So in the core, so cardiopulmonary and epilepsy, our objective is to continue, and this has been stated as objective since Vlad got here, to continue to grow those businesses at above-market growth rates. And with that, continue to grow our bottom line and continue to expand our margins there at a faster pace than revenue growth. So you sort of have to compartmentalize that with the core relative to these growth opportunities, right? These growth opportunities, we'll have to nurture them. We're not naive to say that we'll have to invest behind them, but they do represent significant growth opportunities with very healthy margin profiles. So we're excited about bringing those to market.

Operator (participant)

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

Adam Maeder (Reasearch Analyst)

Hi, good morning. Thank you for taking the questions. I wanted to start with one on the top-line guidance for 2025, specifically around what's assumed for pricing. So just remind us how much price you took in the growth contribution for calendar year 2024. And then how do we think about that 6%-7% organic growth guidance for 2025 and what's assumed for price mix benefit? And then I had a follow-up. Thanks.

Vladimir Makatsaria (CEO)

Yeah. Adam, good morning. Look, with our priceing, and I exclude equipment out of this, so excluding the Essenz upgrade, contributed approximately 250 to 300 basis points of growth in 2024. Price continues to be a strong lever of our performance. But if behind your question is, do we have an upside on this, then I think our opportunity to accelerate growth will come from two areas. And one is to continue gain share in our cardiopulmonary disposables. And two is accelerate beyond 60% penetration of Essenz or gain additional price premium on Essenz. Those will be the big drivers. I think price, like I said, is a strength of capability of LivaNova. And I think it's well reflected in the guide.

Adam Maeder (Reasearch Analyst)

That's helpful, Vlad. Thanks for the color there. For the follow-up, I'll ask about obstructive sleep apnea. It certainly sounds like there's a lot of product development work that's going on behind the scenes. I was hoping you could flesh that out for us. What exactly are you working on? I guess a couple of things. Are you trying to expand or better the recharge burden? Maybe just remind us about the MRI compatibility. Are you looking at a primary cell device? And how quickly can those pieces of innovation come to the marketplace? Thanks for the questions.

Vladimir Makatsaria (CEO)

Yeah, sure. So obviously, we did the clinical trial with a design. And as typically with any of these types of clinical developments, the device that you do the design with and the device that you launch, you do some upgrades. You look at things like manufacturability and yield and some product feature-related improvements. So we are doing a lot of that. MRI compatibility is important to us. So in the full commercial launch, the device will be MRI compatible. That's an important element. When it comes to the primary cell or rechargeable, our position is that there are pros and cons on both. We don't believe primary cell has just pros, and rechargeable batteries are cons. So there are some advantages for having rechargeable. For example, you're not restricted by the energy consumption, so you can apply more therapy because you're not worried about depleting the battery.

What we're really working on is that we have a very unique architectural design. We have six electrodes. What the six electrodes allows us to do is that it really allows you to titrate and do a personalized treatment for each patient. A lot of our efforts are going into how do we continuously upgrade the therapy by fully utilizing this architectural advantage we have with the six electrodes. Our energy is going through more feature sets and improvement of therapy. MRI compatibility, as I said, will be part of the launch. We're not actively working on a primary cell because it will negate some of the architectural advantages we have if we have energy restrictions in the battery.

Very helpful color. Thanks, Vlad.

Operator (participant)

Thank you. We're out of time for further questions. So I'll pass you back to Vladimir Makatsaria for any closing remarks.

Vladimir Makatsaria (CEO)

Thank you, everybody, for joining the call today for thoughtful questions. On behalf of our entire team, we certainly appreciate your support and interest in LivaNova. Have a great day ahead. Thank you.

Operator (participant)

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