LivaNova PLC

NASDAQ:LIVN

Q3-2025 Earnings Call

[Operator]

Good day, ladies and gentlemen, and welcome to LivaNova plc Third Quarter 2025 Earnings Conference Call. [Operator Instructions] 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.

[Unknown Executive]

Thank you, and welcome to our conference call and webcast discussing LivaNova's financial results for the third quarter of 2025. 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 Investors 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, executive]

Thank you, Briana, and thank you, everyone, for joining us today. Welcome to LivaNova's conference call for the third quarter of 2025. In the quarter, LivaNova delivered 13% organic revenue growth versus the prior year, driven by continued momentum in the cardiopulmonary business and solid epilepsy performance across all regions. The ability to sustain strong organic growth, expand margins and drive strong cash generation reflects the durable market leadership positions of our core businesses. The consistent results also speak to the strength of our execution and the productivity improvements we've embedded across the organization. These results also highlight LivaNova's unique ability to drive near-term performance while reinvesting in the core, advancing the obstructive sleep apnea program and maintaining upside optionality in difficult-to-treat depression.

Together, these actions are aligned with our strategic priorities and position LivaNova well for the future. We recently internally launched a new strategic framework alongside the unveiling of a refreshed logo and visual identity, which you may have noticed in today's earnings materials. This new strategic framework and branding reflect LivaNova's direction, momentum and continued focus on growth and innovation. We look forward to discussing these strategic priorities, how we plan to build on our strong foundation and how we will shape the future of LivaNova in more detail at our Investor Day next week on November 12.

Now turning to segment results. For the Cardiopulmonary segment, revenue was $203 million in the quarter, an increase of 16% versus the third quarter of 2024. Heart-lung machine revenue grew over 20% versus the prior year period, driven by sequential acceleration in Essenz placements and sustained favorable price premiums. This includes a significant majority of Essenz placements in developed markets in the quarter. In August, we initiated the commercial launch of Essenz in China, which is our second largest HLM market after the U.S. We've received positive early feedback from hospitals and clinicians, and we're pleased with the launch thus far. Given the length of the sales cycles for Essenz, we expect the rollout to be a more meaningful growth driver in 2026. Cardiopulmonary consumables revenue grew in the mid-teens, driven by market share gains, procedure growth and price.

Strong demand for Oxygenator continues to outpace the market's ability to supply. While our manufacturing capacity expansion plans are progressing well and remain on track, third-party component supply is a limiting factor for even more rapid expansion. Our team remains focused on working with suppliers to meet the production needs. We now expect cardiopulmonary revenue to grow 12.5% to 13.5% for the full year 2025, up from 12% to 13% previously. This forecast assumes continued HLM growth and increased penetration in existing markets. We still expect Essenz to represent approximately 60% of annual HLM unit placements in 2025, up from 40% in 2024. This forecast also reflects robust market and share growth for consumables.

Turning to epilepsy. Revenue increased 6% versus the third quarter of 2024, with growth across all regions. Epilepsy revenue in the Europe and Rest of World regions increased a combined 12% versus the prior year period, while the U.S. epilepsy revenue increased 5% year-over-year. These results reflect strong commercial execution globally. During the quarter, we initiated commercial rollout activities to drive awareness of the CORE-VNS data among the epilepsy clinical community worldwide. While we're still in the early stages of commercial activities, initial feedback from the clinical community is encouraging. Building clinical evidence is a key component of our strategy in epilepsy and the CORE-VNS data is expected to further strengthen our foundation and support future commercial and educational efforts. For the full year 2025, we now expect epilepsy revenue growth of 5% to 6%, up from 4.5% to 5.5% previously.

This forecast incorporates mid-single-digit growth in the U.S. and assumes the Europe and Rest of World regions will grow at combined low double digits for the year. This is consistent with prior guidance, although at the higher end of respective ranges. We continue to see momentum in the global epilepsy business across volume, price and mix. In summary, due to the strong growth we saw in the quarter and continued momentum across all growth drivers, we are raising our overall organic revenue growth outlook by 50 basis points to between 9.5% and 10.5%. We continue to make progress on the obstructive sleep apnea and difficult-to-treat depression programs, and we look forward to providing updates at our Investor Day next week. With that, I'll turn the call over to Alex.

[Alex Shvartsburg, executive]

Thanks, Vlad. During my portion of the call, I'll share a brief recap of the third quarter results and provide commentary on our updated full year 2025 guidance, which reflects strong performance year-to-date and improving business outlook. Turning to results. Revenue in the quarter was $358 million, an increase of 11% on a constant currency basis and 13% on an organic basis versus the prior year. As a reminder, we took a $7 million provision for the Italian payback measure in the second quarter of 2024. Because of recent legislative developments, the company reduced its reserve for the payback matter by $3.8 million during the third quarter of 2025. Excluding these adjustments, organic growth was 11%. Foreign exchange in the quarter had a favorable year-over-year impact on revenue of approximately $5 million or 1%. Adjusted gross margin as a percent of net revenue was 69%, generally in line with 70% in the third quarter of 2024.

This year-over-year decrease was driven by unfavorable currency changes, product mix, incremental investments related to oxygenator capacity expansion and tariff impacts. This was partially offset by favorable pricing across segments and geographies. Adjusted SG&A expense for the third quarter was $123 million compared to $112 million in the third quarter of 2024. SG&A as a percent of net revenue was 34%, generally in line with 35% in the third quarter of 2024. The year-over-year decline as a percent of net revenue was driven by fixed cost leverage. Adjusted R&D expense in the third quarter was $45 million compared to $47 million in the third quarter of 2024. R&D as a percent of net revenue was 13%, down from 15% in the third quarter of 2024.

The year-over-year decrease was driven by cost optimization of the DTD program as we pursue CMS coverage. Adjusted operating income was $80 million compared to $64 million in the third quarter of 2024. Adjusted operating income margin was 23% compared to 20% in the third quarter of 2024. This increase was primarily driven by higher revenue, fixed cost leverage and optimization of DTD program spend. Adjusted effective tax rate in the quarter was 22%, principally in line with the third quarter of 2024. Adjusted diluted earnings per share was $1.11 compared to $0.90 in the third quarter of 2024. The increase was primarily driven by adjusted operating income growth. We continue to make progress in generating cash. Our cash balance at September 30 was $646 million, up from $429 million at year-end 2024. This increase reflects improvements in operating cash flows and the release of $295 million of restricted cash following the SNIA litigation guarantee termination.

Total debt at September 30 was $434 million compared to $628 million at year-end 2024. The reduction in total debt was a result of the $200 million early repayment of the term facilities. Adjusted free cash flow in the first 9 months of 2025 was $130 million, up from $101 million in the prior year period. The year-over-year increase was primarily driven by stronger operating results and disciplined working capital management. Capital spend in the first 9 months of 2025 was $49 million compared to $37 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 updated 2025 guidance. As Vlad mentioned, based on performance to date, we're increasing full year 2025 revenue, adjusted earnings per share and adjusted free cash flow guidance. We now forecast 2025 revenue growth between 8.5% and 9.5% on a constant currency basis and between 9.5% and 10.5% on an organic basis.

We continue to expect the impact of foreign currency to be a tailwind of approximately 1%. We continue to forecast a full year adjusted effective tax rate of approximately 23%, which represents an increase of 200 basis points versus 2024. To reflect stronger operational performance, we now project adjusted diluted earnings per share in the range of $3.80 to $3.90 with adjusted diluted weighted average shares outstanding to be approximately 55 million for the full year. This higher range is primarily driven by increased revenue expectations and productivity improvements. This $0.10 increase continues to reflect an investment in the Essenz printed circuit board conversion, as we discussed last quarter, which is expected to increase cost of goods in the fourth quarter. As a reminder, the printed circuit board investment will support future advanced Essenz software updates. Adjusted free cash flow is now expected to be in the range of $160 million to $180 million, which is $20 million higher compared to our prior guide due to higher net income expectations and working capital improvements as well as lower capital spend.

For the year, capital expenditures are now expected to be approximately $80 million, down from $95 million previously due to the cadence of capital projects. I'd also like to call out that the guidance ranges shared today incorporate our best estimate of the potential impact of currently applicable tariffs. As previously discussed, we have a tariff mitigation plan in place that includes both a holistic assessment of our supply chain as well as potential pricing actions. Based on the assessment, LivaNova remains well positioned to manage the impact of tariffs. Consistent with our prior guidance, we estimate a tariff net impact of less than $5 million on adjusted operating income for the full year. The 2025 guidance range shared today fully incorporates the impact from currently applicable tariffs. We acknowledge this is a dynamic environment, and we continue to monitor it closely.

In summary, we had another quarter of strong performance marked by double-digit organic revenue growth, which drove 250 basis points of operating margin expansion. This translates into a 23% increase in adjusted diluted earnings per share and a 32% improvement in adjusted free cash flow. These results also underscore the impact of disciplined execution and productivity across the organization. Our updated 2025 guidance reflects the strength of our businesses and continued investment in the core and innovation pipeline. With that, I'll turn the call back over to Vlad.

[Vladimir Makatsaria, executive]

Thank you, Alex. In closing, LivaNova delivered another quarter of strong performance, underscoring the durability of the core cardiopulmonary and epilepsy businesses as a strong foundation for the company. Our results this quarter also reflect disciplined execution, enhanced productivity and operational excellence. In the third quarter, we continued to expand margins and generate cash while still investing in innovation priorities. At the same time, we continue to leverage our neuromodulation expertise to progress the obstructive sleep apnea and difficult-to-treat depression programs. These initiatives represent significant opportunities to address large patient populations with unmet needs. They position LivaNova for expansion into additional attractive markets where we have a clear right to win and can drive durable long-term growth.

With a strong team and clear strategic priorities, we are confident in our ability to sustain momentum and create lasting value for patients, customers and shareholders. We look forward to sharing our vision for the next chapter of LivaNova and the strategic priorities that will drive long-term growth and value creation in greater detail at our Investor Day next week on November 12. With that, we're ready to open the call for questions.

[Operator]

[Operator Instructions] First question comes from Michael Polark with Wolfe Research.

[Michael Polark, analyst]

I'm going to start in the release on just the fourth quarter and what's implied there. If I do the simple math on EPS, I'm getting $0.80 flat year-on-year. It just looks extremely conservative relative to the performance year-to-date. It implies gross margin down -- operating margin down a lot sequentially year-on-year. And so Alex or Vlad, I'm hopeful you can walk us through a little more precisely like puts and takes in the fourth quarter, anything that you're bracing for in this guide that the Street might have been under considering. I heard about the PCBA conversion. Maybe that's a big piece of the answer. It could be tariffs as well. But any further context on the fourth quarter implied earnings outlook, I would appreciate.

[Alex Shvartsburg, executive]

Mike, it's Alex. Yes, you're absolutely right. The printed circuit board investment that we're making is indeed happening in the fourth quarter. In my prepared remarks, I referred to a $0.10 impact. That's what the key driver [ is of kind of ] the softer Q4. And if you recall, we talked about the investment in PCBA as a -- it's a platform for us to continue to drive strategic revenue in the future with software and service. So that's -- it was a planned investment. We kind of foreshadowed it last quarter, and it is indeed happening in Q4.

[Michael Polark, analyst]

I'll ask a follow-up on oxygenators. Obviously, the cardiopulmonary performance impressive again. On the consumables side, I heard 2 things, just good volumes, good share take, good price. I heard good progress on your internal capacity expansions, but I heard caution again on kind of third-party component supply. So can you unpack for us a little more on the internal capacity investments, remind us how much you're adding there and when these projects are expected to complete on the third-party supply front, have things gotten tighter Q-over-Q, about the same Q-over-Q? And what's the path from your perspective for that piece to relieve as you roll into '26?

[Vladimir Makatsaria, executive]

Yes. Thanks, Mike, for the question. It's indeed gaining share in oxygenators has been and will continue to be one of our key growth drivers. We have very strong momentum over the last 24 months in terms of share gains, and that is supported by our ability to continue manufacturing -- expanding our manufacturing. So last year, if you recall, we've increased our capacity by around 10%. This year, again, our capacity expansion is close to 15%. However, our actual output for the full year will be below 10%. And that gap is driven by deficit in third-party component supplies. We're working very closely with a group of our suppliers to make sure that we continue to improve that situation and do our best to close the year strong.

Now for the next year, we are actually adding another manufacturing line within LivaNova. It's been an ongoing investment and projects that we have been driving. So that will allow us to have a step change in our own manufacturing capacity. And obviously, we're working closely with all the suppliers to make sure that they continue to grow and expand their capacity as well.

[Operator]

We now turn to Adam Maeder with Piper Sandler.

[Adam Maeder, analyst]

Congrats on a nice quarter. Two for me. The first one is on the Q4 implied guidance. Mike just asked about bottom line, but maybe I'll ask about the top line. I think the implied Q4 revenue growth suggests a growth deceleration. And when I look at the prior year comp, it looks easier. So maybe just square that for us. Is it largely conservatism? Or are there some other considerations that we should be aware of in the top line outlook for Q4?

[Alex Shvartsburg, executive]

Adam, Look, our revenue guide for Q4 is prudent. The biggest item I would call out is the Q4 comps related to the HLM, right? We had a really big quarter last year. And so just kind of the compounding effect is causing this deceleration, if you will. But look, we're continuing to perform well and really pleased with an 8% growth for Q4. So I think we're in pretty good shape.

[Adam Maeder, analyst]

Okay. I appreciate the color there, Alex. And just for the second question, HLM, Q3, I think, marked your first quarter with Essenz in China. That's your second largest end market. And it looks like we did see Rest of World growth pick up a little bit. Can you just help us better understand the expectations for launch in the Chinese market? I heard more of an impact in '26, but if you could just kind of flush that out for us a little bit more in terms of cadence of rollout? And then just remind us the current installed base there and the opportunity for China, that would be helpful as well.

[Vladimir Makatsaria, executive]

Yes. So thank you for this question as well. So we launched -- we had a commercial launch in China in August. It's about 6 months before the kind of the internal target date. And that's a really good sign for us from the Chinese market, both from the clinicians, but also from regulators that means there's a high demand for this product. So far, the feedback from the clinical and the hospital community has been very strong, very good on the launch. The selling cycle on the equipment is relatively long, obviously, than the disposables. And so that's why I kind of made a comment that we expect the majority of growth impact starting in 2026. So if you recall what we've always said, we -- last year, 40% of our worldwide placements were Essenz. This year, 60% of all HLMs placed globally will be Essenz. And then next year, 80% of all HLMs placed around the world will be Essenz. And China will be the main contributor to that upside from 60% to 80%.

And then during the Investor Day next week, which I hope you can attend, we will unpack a little bit more the opportunity in China and specifically what we expect from launch.

[Operator]

We now turn to Matt Taylor with Jefferies.

[Matthew Taylor, analyst]

Nice to see the neuro growth stabilizing here. I was wondering if you could just, at a high level, talk about the trajectory into next year for that business given we will start to see some of the roll-off of the COVID implant headwinds and you have these other helpers, including the new reimbursement for replacements and the DRE data. Could we see a pickup in that growth next year?

[Vladimir Makatsaria, executive]

Yes. So thank you for the question. So I'll make it compartmentalize a little bit. There will be 2 occasions that we will share in more detail our longer-term projections on epilepsy as well as expectations for '26. So again, November 12 is our Investor Day, and then we will guide early in the year for 2026. But a little bit of flavor on what we're starting to see in terms of results. I think 2 things. One is strong execution globally. So we continue to just improve our level of commercial execution, and that pays off with consistent results across the world. Number two, we had CORE-VNS study results out. That's the largest to date real-world evidence study. And we're starting to deploy the results of the study to the clinical community and starting to get very positive results. And so maybe after I finish, I'll ask Ahmet just to say a few points about that. And then to your point on -- we're very pleased on the reimbursement improvement that is anticipated as of January 1 with the shift from Level 4 to Level 5 on the end of service units. And that obviously improves economic viability of -- over the lifetime of VNS patients for the providers. And so that clearly is an important growth driver for us moving forward. And we'll continue to work on market access and improved reimbursement also for the NPIs. So maybe, Ahmet, if you can comment a little bit on the CORE-VNS.

[Ahmet Tezel, executive]

Sure. As Vlad stated, this was the largest study to date with VNS with 800 patients. And because it was large, it allowed us to do subgroup analysis because we had large sample sizes. And the outcomes kind of further validated the early and sustained reductions in seizure frequency across multiple seizure types, including the most severe and disabling seizures. For example, I'll just give you one data point. At 36 months, the analysis showed that the median seizure reduction was 80% for focal onset seizures. So we're still, as Vlad stated, in the middle of rolling the data out, but we're getting very, very strong feedback from physicians about the strength of the data.

[Matthew Taylor, analyst]

Got you. Maybe I just ask one follow-up. I know you probably want to comment on the pipeline next week. But I did want to get an update on the process for depression. I think last quarter, you said it could be about a year before we see a decision. Is it now 6 to 9 months? Or is there anything new on timing or your confidence in getting coverage there?

[Vladimir Makatsaria, executive]

So in terms of the process, yes, the fundamentals have not changed for us with regards to the time line. So we submitted our draft application. CMS has given us some questions. We view that as a positive part of the process. We answered their questions and then the government went to shutdown. So right now, because of that, there's a pause. As soon as the government opens, we will go back with the process. And the next step is to do our formal application. Now from that point on, there is no strict time lines. But as a reference, and it's just a reference, Medtronic just complete the renal denervation. And for them, the process took 11 months in total from the time of the formal application to having the reimbursement completed. So we are also hoping that the process for us will be within that kind of time frame of 1 year. So nothing has really changed for us. The only thing is this kind of a temporary pause with the government shutdown.

[Operator]

We now turn to Anthony Petrone with Mizuho.

[Anthony Petrone, analyst]

Congrats here on the quarter. Maybe one quick one on Essenz and then a high-level question. Just maybe a little bit on the contribution from the China launch in the quarter and how that product cycle in China, Essenz specifically will sort of evolve here over the next 12 months? And then I'll have a quick high-level follow-up.

[Alex Shvartsburg, executive]

Anthony, in terms of China, for the quarter. We actually saw some early indications of kind of positive reception. We had some orders come into Q3. I think there was kind of the mad rush ahead of the Golden Week to get these orders in by certain distributors and hospitals. But it's still early on in the game. And as Vlad said, we're going to see most of the impact next year from that launch.

[Anthony Petrone, analyst]

And then maybe just high level, as we head in Analyst Day, when you think about managing the top line growth algorithm with just your priorities at EBITDA, obviously, 2 new initiatives here, depression and sleep. Maybe just a little bit of a preview on how the company is prioritizing top line growth over EBITDA margin expansion and earnings. And congrats again, and look forward to seeing everyone next week.

[Alex Shvartsburg, executive]

Look, we don't want to preempt discussion today for Investor Day. We'll -- next week, we'll connect the dots between our current execution and our financial ambitions for the long-range plan. So again, kind of looking forward to sharing the details of our long-term strategy and financial objectives next week on November 12.

[Vladimir Makatsaria, executive]

And Anthony, I look forward to seeing you next week, and thank you for taking the time to join us.

[Operator]

We now turn to David Rescott with Baird.

[David Rescott, analyst]

Congrats on the quarter here. I wanted to follow up on some of the comments around this investment behind the CORE-VNS trial. More curious about how internally you're expecting to gauge what the benefits of that investment can be and over what period? I know there's some elevated reimbursement on the end of service potentially being a benefit for new centers opening up or maybe new centers adopting this therapy. I'm not sure there's been an update on the NPI reimbursement. But is this something that you'll see on the ground level as it relates to exploring new implants to just more centers onboarding VNS therapy? How are you thinking about gauging kind of the success of what CORE-VNS showed in the financials, I guess, of the company?

[Vladimir Makatsaria, executive]

So David, and very important question. Thank you for asking it. Look, I think this is -- if you look at 1/3 roughly of epilepsy population have resistant to drugs. And then it takes 10 to 15 years to get from the diagnosis of being a DRE patient to actually getting or seeking for treatment. And if you look at the kind of across various clinical specialties, treatment of drug-resistant epilepsy patients has one of the lowest penetrations. And there are a number of barriers or if you flip the drivers that will contribute to improvement of that penetration. And you mentioned the 2 of them. One is reimbursement and making sure that hospitals also have financial economic benefit from those procedures. And we made a major step on that in terms of Level 4 to Level 5.

And like I said, we'll continue to work on Level 6 for the NPIs as well. The other kind of clinical strategic direction is in the innovation area is how do we make sure that we continue to create products and procedures that are less invasive and more clinically effective. And ultimately, that is the goal of innovation, minimally invasive, more clinically effective. And what CORE-VNS study shows is that with relatively less invasive procedures like VNS, we are starting to see really strong long-term results. And that is an important data point for the clinical community to drive penetration of the procedure. And so I'll turn it to Ahmet a little bit to talk more from a scientific point of view.

[Ahmet Tezel, executive]

Yes. In terms of the investment, in terms of the data investment, the investment is mostly done. So from this point on, we're talking publications, advisory boards and things like that, that are not substantial investments from an investment standpoint. I'll add 2 comments to what Vlad said. One, the data show that the earlier you start VNS therapy, the better clinical outcomes are. So I think that's an important learning of the study that we are going to ensure that our physician base understands. So that could kind of accelerate a little bit of utilization because earlier is the better. And as Vlad talked about it, we're investing a lot in simplifying the workflow. And we also show with the CORE data that dosing and titration and getting that right is really, really important. So anything we can do to make the workflow easier and faster helps the end outcome. So I think those will be the 2 key points I will make. Earlier utilization of VNS is really important and impactful according to the CORE data and dosing and titration is really impactful. So we're investing a lot in making that a lot easier for our physicians and patients.

[Vladimir Makatsaria, executive]

And David, I'm going to keep promoting our Investor Day because I think it will be important to kind of take a look at a holistic strategy on how we continue to grow epilepsy. And this is obviously an important leg of that strategy. So I hope to see you there, and we will unpack a little bit more in terms of our holistic approach to driving durable growth in the epilepsy business.

[David Rescott, analyst]

Okay. That's helpful. Two, I guess, kind of clarification questions on some prior comments. First on the China rollout contribution in 2026. I heard you talk about the shift from the 60% to 80%. Is China the way or the reason that you get to the 80%? Or is potentially China an upside to getting to 80%? And then on the oxygenator manufacturing capacity, I heard that new manufacturing line next year, that will be a step change, I think you said on the impact. Just curious if you can qualify or quantify what your definition of step change is, and we'll see the team at the Analyst Day next week.

[Vladimir Makatsaria, executive]

Yes. So I'll start maybe with the second one. So we expect the new line to be -- to go live in the second half of the year. So that's when we will start seeing acceleration beyond just ongoing improvements within the current network. And the step change, so we won't guide specifically to our exact capacity increase, but it will be beyond what we have done historically on an annual basis. So that's the first one. And then -- so that's the second one, sorry. On the first one, so China is a big driver. Remember, there are 2 drivers on the growth of HLM. The first one is this kind of percent improvement of placement penetration, call it, during the year. So we're going from 60% to 80% next year. And yes, China will be the major contributor to that upgrade.

The second one, and if you look over the last few quarters, and this is where the biggest upside came from in terms of our growth, same in quarter 3 is with the fact that we are able to maintain very strong price premium on Essenz versus S5. And -- and that ability to preserve price premium is actually a very strong indicator of value proposition of Essenz to the clinical community. And so one of our targets and using your point, could that be an upside is to make sure that we continue to preserve price premium as we roll out Essenz across the world.

[Operator]

We now turn to Mike Matson with Needham.

[Michael Matson, analyst]

So just a few on the oxygenator business. So are there any signs of your competitors trying to expand their production? And then what's your confidence that the demand remains as strong as it's been, particularly the, I guess, procedural-driven component of that? And then if the growth were to slow -- or demand were to slow down, is there any -- as you've added this capacity, would that pressure your margins or anything like that? Or is it easy enough to kind of turn it off if you see things slow down?

[Vladimir Makatsaria, executive]

So very good question. So I'll start with the second part of it. So the way we're building our additional capacity is in a very financial disciplined manner. So fluctuations in the demand within a certain range are not going to impact negatively [ our kind of this ] type of investment, and we won't see any negative pressure on the financials. On the first part of the question, so we have now, over the last 2 years have seen the momentum of share gains. And we believe that we are now -- we've gained share from low 30s to very high 30s now in terms of percent share in a very mature market like oxygenator, you rarely see that. And we attribute that not to a disruption in the market with competitors, but the fact that we have not seen any investment and innovation or capacity increase from Medtronic and Terumo. And obviously, from getting there, we saw exit from this part of the -- from this segment of the market. So we continue to gain share.

Our first step is to continue gaining share through improved supply. And the second step will be to launch new generation oxygenator. We're going to talk about the clinical value that it brings during the Investor Day. So we see share gain in oxygenator as not just a short-term blip, but it's a long-term strategy, and we have execution plan behind that. And then to the market growth, look, we are learning more and more about what drives the procedure growth, and it's multidimensional. Part of it is that we're just as a society, getting older and getting more open heart surgeries. Number two is emerging markets where open heart procedure penetration is lower and has more runway for growth. Those markets are becoming bigger part of the pie. And so that kind of contributes positively to overall growth.

And then finally, we believe that there was a kind of lack of diagnosis during COVID, and that resulted in more advanced heart disease for patients after COVID. So that potentially will go -- that part of the market growth will potentially go away. And then finally, on the valve procedures, we see a more robust growth on valve procedures as kind of TAVI growth kind of momentum is flattening.

[Alex Shvartsburg, executive]

And Mike, I would just add the fact that the market is continuing to be a very robust market. We're still operating in a back order situation. So the demand is outpacing the market's ability to supply, right? So we're building capacity to address the demand that we're seeing. And as Vlad said, we're going to do this in a financially disciplined manner. And we need to build this capacity also in light of the fact that we're going to ultimately start converting to our next-generation oxygenator. So there needs to be that transition point.

[David Rescott, analyst]

Yes. Okay. That makes sense, especially with the new oxygenator coming. So -- and then just one quickly on the HLM side. With the PCB upgrade, how involved are the sales reps going to be in terms of managing that with the customers? And is this something that could potentially distract them from selling HLMs and oxygenators in the fourth quarter?

[Vladimir Makatsaria, executive]

No. Yes, it's a good point. No, it's a service organization that will execute the upgrade. And then there will be no disruption for sales organization.

[Operator]

We now turn to John McAulay with Stifel.

[John McAulay, analyst]

Just wanted to go back to the free cash flow we saw in the quarter. So conversion rates above 90% on a last 12-month basis, near $200 million in total. Just want to get a better sense. I know SNIA is still ongoing here. But is there anything that we can attribute maybe in the future to greater M&A capacity or other in terms of investments in the business that you're getting with this stronger free cash flow generation on the overall strategy?

[Alex Shvartsburg, executive]

John, thanks for your question. Look, we -- if you look at our cash position, very well positioned to address the SNIA payment. And I appreciate you calling out the fact that we're -- our cash generation has improved. Yes, obviously, it gives us -- putting SNIA behind this ultimately gives us the flexibility to deploy our capital against strategic initiatives and M&A is one of those tools that we will look to. So I think it's important for us to continue to focus on improving our cash generation. That is -- that's the lifeline for any company to be successful is to drive cash flow.

[John McAulay, analyst]

Great. That's helpful. And a follow-up on the epilepsy business. You talked a lot about the CORE-VNS study so far and how that's contributing. Also just wanted to get a sense of what's going on the ground in terms of the team's commercial presence, the reps, CC teams. Just all these initiatives that you've put in place, how are they working to drive greater overall market penetration? And just what inning do you think we are in, in terms of seeing this number steadily increase?

[Alex Shvartsburg, executive]

John, look, so the epilepsy business, really pleased with our performance in the quarter and year-to-date. The commercial teams have executed extremely well, particularly coming out of the field safety notice situation that we had in the quarter. So we're starting to catch up in terms of deferred procedures that we saw. And it's a multifaceted approach to driving penetration in the marketplace. As a market leader, we're obviously focused on driving data generation, clinical evidence to support the therapy, the health economic reimbursement improvements are going to help us. This is -- it's part of our overall strategy to drive growth. And again, we keep pitching Investor Day, but we'll unpack a lot of that next week when we talk about our long-range strategy.

[Operator]

We now turn to Matt Miksic with Barclays.

[Matthew Miksic, analyst]

So congrats on the quarter and on the momentum here. I just wanted to follow up on one aspect of the sort of next, call it, next set of drivers, indications, which I'm sure you'll get into next week on DTD and OSA. If you could sort of give a sense of where -- how those -- what those investments look like, 2 very different to me anyway, opportunities and very different set of investments and different challenges facing each. Maybe if you were to think about the P&L and the profile [ of the ] when and how do we see, say, DTD phasing into your intermediate and long-term growth? And at a high level, when and how do we see OSA potentially phasing into intermediate and long-term growth. Understanding, of course, you don't really want to get into everything now.

[Alex Shvartsburg, executive]

Yes. Matt, thanks for the question. And it's a really good lead into the Investor Day. I think we will spend majority of our time talking about our plans to launch OSA and then our progress with depression. So both from the strategy point of view, the value proposition point of view, but also potential financial impact. All of this will be unpacked on November 12.

[Matthew Miksic, analyst]

Okay. Fair enough. And then just maybe in this next quarter, understanding that you're already investing a fair amount of spend into these programs. You called out the sort of the circuit board investments and some of the other businesses you're ramping up [ PVA ] in the fourth quarter. Can you quantify what you're -- if you're picking up the investment in Q4 at all from current levels or maybe just a level check on sort of what the quarterly spend looks like and how that's progressing in advance of the bigger plan you'll unveil next week.

[Vladimir Makatsaria, executive]

Matt, thanks for your question. Look, Q4 is always -- we always see an uptick in spend. It's our kind of the biggest quarter in terms of our OpEx, both SG&A and R&D. So that's all factored into the full year guide.

[Matthew Miksic, analyst]

Understood. But no color, you sort of safe to say you're sort of maintaining spending levels in those 2 programs or no significant change from Q3 to Q4. Is that fair? Or do you see a step-up that's not consistent with, as you point out, sort of the seasonal step-up in OpEx?

[Vladimir Makatsaria, executive]

No, it's pretty consistent. There's no step-up in investments. And I think I'm trying to read into what you're alluding to, as Ahmet said, given the time lines for both DTD and OSA, there are no incremental investments in Q4 related to those programs.

[Operator]

And our final question today comes from David Roman with Goldman Sachs.

[Unknown Analyst]

This is Jamie on for David. I hate to belabor the 4Q guidance question. But as we think about last year, a similar dynamic unfolded. You provided Q4 guidance that many of us perceived as conservative given the year-to-date trends and all modeled ahead of your guidance. And then you ended up doing sort of exactly what you said you would do, and that created a lot of volatility early in 2025. How do you consider these dynamics in constructing the outlook for 4Q?

[Alex Shvartsburg, executive]

Jamie, look, we guide to a specific set of numbers for, obviously, full year is 1 quarter remaining. We're not expecting anyone to model kind of ahead of the numbers that we're calling. So I would just say, look, we're pleased with our results year-to-date, and our guide reflects kind of the balance to go in Q4. So I'd encourage you to adjust your models accordingly.

[Unknown Analyst]

Okay. And I know you'll get into 2026 more next week. But if we lay out some of the headwinds, which would be incremental interest expense from eventual payment of SNIA, annualization of tariffs, investment in OSA against some of the tailwinds, the China Essenz launch, PCBA upgrade completion, capacity for oxygenators, how do the headwinds and tailwinds balance each other going into next year?

[Vladimir Makatsaria, executive]

Look, we're in the planning process at this stage, and there's many puts and takes at this point in time. I can talk to as many headwinds as tailwinds. So I would say we'll talk about our 2026 guidance in February.

[Operator]

This concludes our Q&A. I'll now hand back to Vladimir Makatsaria for any final remarks.

[Vladimir Makatsaria, executive]

Okay. Well, thank you so much, and thank you, everyone, for joining us on this call today. And on behalf of all of us, we really appreciate your support and interest in LivaNova, and I hope to see you at our Investor Day on November 12. Thank you, and have a great day.

[Operator]

Ladies and gentlemen, today's call has now concluded. We'd like to thank you for your participation. You may now disconnect your lines.