Good day, ladies and gentlemen, and welcome to the LivaNova PLC Second Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's call, Ms. Briana Gotlin, LivaNova's Vice President of Investor Relations. Please go ahead.

Thank you, and welcome to our conference call and webcast discussing LivaNova's financial results for the second 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; Stephanie Bolton, President of Global Epilepsy 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 & Presentations at investor.livanova.com. With that, I'll turn the call over to Vlad.

Thank you, Briana, and thank you, everyone, for joining us today. Welcome to LivaNova's conference call for the second quarter of 2025. In the quarter, LivaNova delivered 10% organic revenue growth versus the prior year, driven by continued momentum in our cardiopulmonary business and solid neuromodulation performance across all regions. Our ability to sustain strong organic growth reflects not only robust demand, but also disciplined execution across our portfolio. This execution also contributed to meaningful operating margin expansion and strong cash generation. Before turning to segment results, I'd like to highlight how important clinical and regulatory milestones from the quarter. In epilepsy, we announced long-term results from the CORE-VNS study, the largest real-world evidence study of VNS therapy to date. The data shows clinically meaningful and durable results demonstrating the effectiveness of VNS therapy in both children and adults with drug-resistant epilepsy or DRE. The outcome further validate early and sustained reductions in serious frequency across multiple seizure types, including the most severe and disabling features. For example, the 36-month data analysis showed a median seizure reduction of 80% in patients with focal onset seizure with impared awareness and 95% in those with focal to bilateral tonic- clonic seizure. These results have been well received by the clinical community and I expect it to strengthen the foundation of our epilepsy franchise while supporting our commercial and educational initiatives going forward. In difficult-to-treat depression, or DTD, we initiated the process with CMS to seek national Medicare coverage for VNS therapy in unipolar patients with treatment-resistant depression. The first step in the process for CMS reconsideration was the submission of a draft formal request. This request is supported by 5 peer-reviewed publications from the RECOVER study and strong 24-month outcomes, demonstrating the durability of VNS therapy in the severely ill patient population.…

Thanks, lot. As Vlad highlighted, we recently announced long-term data from CORE-VNS, which is our largest global prospective study ever conducted. This is the strongest and most compelling data to date showing that VNS therapy delivers durable meaningful seizure reduction. CORE-VNS further validated the effectiveness of VNS therapy on severe focal seizures in both children and adults with DRE and demonstrated that VNS therapy is associated with substantial reduction in generalized tonic-clonic seizures in people with DRE. This data demonstrates that patients with DRE who have exhausted numerous treatment options and continue to suffer frequent debilitating seizures benefit from VNS therapy. We published compelling 24-month data on generalized tonic-clonic or GTC seizures in patients who have failed as many as 20 antiseizure medications and had a median of 4 GTC seizures per month at baseline. At 12 months, the median reduction in GTC seizure frequency was 74 and was sustained through 24 months increasing to 77%. The CORE-VNS 36-month data analysis, which Vlad previously discussed, also reaffirms the effectiveness of VNS therapy on severe focal seizures in pediatric and adult patients. The effectiveness was noted as early as 3 months after implantation followed by further substantial reduction at the 12-, 24- and 36-month study visit. This strong data in a very large patient cohort is important for our strategy and will support our efforts to narrow the treatment gap, increase access to care and drive awareness of surgical therapies for this significantly underpenetrated CRE population. Turning to difficult-to-treat depression. In May, we initiated the process with CMS to seek national Medicare coverage for VNS therapy in unipolar patients with treatment resistant depression, or TRD. Our application is supported by 5 peer-reviewed publication from the RECOVER study. The fifth critical paper which was recently published in the Journal of Clinical Psychiatry,…

Thanks, Ahmet. During my portion of the call, I'll share a brief recap of the second quarter results and provide commentary on our updated full year 2025 guidance, which reflects our strong first half performance and improving business outlook. Turning to results. Revenue in the quarter was $353 million, an increase of 9% on a constant currency basis and 10% on an organic basis versus the prior year. As a reminder, we took a $6 million provision for the Italian payback measure in the second quarter of 2024. Excluding the prior year adjustment, organic growth was 8%. Foreign exchange in the quarter had a favorable year-over-year impact of approximately $4 million or 1%. Adjusted gross margin as a percent of net revenue was 69%, up from 68% in the second quarter of 2024. This year-over-year increase was driven by the provision taken in the second quarter of 2024 for the Italian payback measure as well as positive pricing and geographic mix. During the quarter, as part of our ongoing audit procedures, we identified that direct labor and overhead costs related to cardiopulmonary service business were misclassified as SG&A expenses instead of cost of goods sold. As a result, we performed a reclassification of $4.8 million from SG&A expense to cost of goods sold for the second quarter on a prospective basis. To be clear, this reclassification is restricted to a small portion of operating expenses and there is no impact on historical or expected net income, operating profits or cash flows. For additional information, including the historical reclassification, please refer to the supplemental table provided in the earnings release issued earlier today. Adjusted SG&A expense for the second quarter was $121 million compared to $109 million in the second quarter of 2024. SG&A as a percent of net revenue was…

Thank you, Alex. In conclusion, we are pleased with the strength and durability of growth in our cardiopulmonary and epilepsy businesses, which delivered 10% organic growth and 160 basis points of operating margin expansion through the first half of the year. We're building on the strong foundation by investing behind our core businesses to sustain our market leadership and clinical excellence. We are excited about our advancing OSA programs which represents a significant long-term opportunity for LivaNova. We make an important progress towards CMS reimbursement for consideration in difficult-to-treat depression. Consistent with our strategy to extend the portfolio into high-growth markets and address large patient populations with significant unmet needs. OSA and DTD each provides meaningful and distinct opportunities to accomplish this goal. With our strong team and critical milestone achievements, we are well positioned to sustain our momentum and capitalize on the opportunities that lie ahead to drive long-term value creation. We look forward to discussing each of these opportunities in greater detail at our Investor Day later this year. With that, we are ready to open the call for questions.

[Operator Instructions] First question comes from Rick Wise with Stifel.

Good to see the strong quarter of positive execution and all the good news. A lot to talk about. I guess I'll start with the epilepsy business. Maybe talk us through maybe in a little more detail the positive data that Ahmet walked us through? And maybe help us better understand how you -- how we should imagine you leveraging the data, the implications for growth, for patient access, et cetera, et cetera. Just help us understand how we translate that into the outlook.

Rick, this is Ahmet. So maybe I'll start and then ask Steph to talk about the impact it will have. So this was a very large study over 800 patients that allows us to look at subgroups as well. We only see new -- the impact that VNS has on patients, but this is the largest study to demonstrate it in a very broad population. We were particularly pleased with the 3-year data on focal epilepsy showing 81% reduction in seizures. We also have 24-month data on generalized, which also showed a reduction of 77%. Now we have 36 month data as well, which also is very strong, but we haven't published yet, but that's why we're only talking about 24 months. The impact is going to be broad. We can utilize this obviously for publications. We can utilize it with regulatory agencies, we can utilize it to broaden our label, working with regulatory agencies. So it's a large study that has a major impact. We're very pleased with the results. But I'll ask Steph to comment around the impact and the feedback she's hearing from our physicians.

Thanks, Ahmet. And good to speak to you. First to say, I'm going to give anecdotal feedback rather from the field. But these results have been extremely well received so far by our investigators and also our key opinion leaders in our clinical community. -- and they're very much expected to strengthen the foundation of our epilepsy franchise. We are at the very beginning of our rollout activities, but the feedback early on is really encouraging. So KOLs telling us that the strength and the size of this data set will change how they counsel patients about VNS therapy and we'll likely mean they consider VNS earlier in their treatment algorithm and will also drive penetration of the therapy. So whilst it's a little bit premature to comment more precisely on the impact of the business. At this time, we see the clinical evidence of the key components to our epilepsy strategy and so far has been very well received.

That's great. I'm just going to stick with a couple of high-level questions here and stick with sort of the same related topic, but the CMS boosting or proposal to boost end-of-service procedures to Level 5 from Level 4, sounds meaningful. It sounds significant. So on the good side, again, talk to us about how quickly -- assuming that their proposal holds, talk about how you would take action, what that could mean for the outlook for the business in '26, how quickly it could be impactful? And I apologize if I'm misremembering, is this the same proposal that was made last year and didn't go through? Or am I just totally confusing the topic?

Thanks, Rick. Let me give you some background. So first to say that we are really pleased with the CMS recommendation to move end-service or EOS procedures to Level 5. This would mean that our providers would have a meaningful increase in reimbursement support for those hospitals that provide VNS therapy to Medicare patients. The proposal will give our centers about a 48% increase in reimbursement, the EOS. And as a reminder, EOS compromises or comprises rather of 70% of our implants in the U.S. and 40% of DRE patients are under our Medicare plans. So if finalized, the change will take effect from Jan 1, '26. Now in terms of impact, this is for the proposal. Nevertheless, any meaningful change to alleviate cost pressure is a positive step forward to creating a real sustainable financial position for our providers that are supporting the lifetime of care for that patient with DRE. So while it's premature to comment on the exact impact, we believe is finalized, this will have a very positive impact on procedure penetration. And we and the team remain highly confident and optimistic that the proposal will be finalized. So if we think a little bit about Level 6, so that was part of our strategy, and it really is the tip of the arrow when we look at our reimbursement activities. We still believe that, that is core and central to our mission around NPI, and we're going to continue to work with CMS and other stakeholders in order to prioritize Level 6 in the coming discussions.

We now turn to David Roman with Goldman Sachs.

I wanted just to start with the oxygenator business. And maybe you could break down a few of the different moving pieces here into what you're seeing from an underlying demand standpoint? And I -- then secondly, what's happening from a LivaNova and industry capacity standpoint I believe it was about at this point in time when you were expected to have additional capacity come on. But are we at a point such that the capacity continues to chase the demand? And what are the factors influencing that?

David, thank you for the question.So first of all, let me start by saying that we see a very healthy procedure growth levels elevated from historical rates. So we are in mid-single-digit growth. We estimate the procedure growth to be mid-single-digit growth, and we see that trend continue. If you look at our performance over the last couple of years, we have been gaining market share, and we estimate that we kind of move our market share from low 30s to now very high 30s in terms of percentage. And we estimate that we benefited from -- our market share gains came from both market growth and gaining some of the share from the competitor. So that's number two. We see that strong momentum continue moving forward. Now if I move into the kind of the supply from the market, so the supply is not catching up to demand. I think the market was a couple of years ago was caught by surprise a little bit on the procedure growth elevation. So we have been working hard to improve our capacity and output. So last year, we've increased our output by 10%. That was driven by improved processes and improved -- increased number of shifts. This year, we continue to improve our processes and shift, at the same time, our suppliers have invested in extension of their capacity. And so we estimate that this year will be somewhere in the high single-digit output growth versus last year. The next year, we are adding another manufacturing line that is tracking well. And so we anticipate that another significant improvement in the output next year. I'll comment in the remarks regarding third-party suppliers in our capacity means that we have kind of -- we've built capacity ahead of our kind of third-party suppliers' ability to provide us with some of the components. In other words, the more components we get today, we can increase our output further this year as well. But net-net is we continue to gain share, and we don't see too much differentiated activity from our competitors in this case.

Very helpful. And maybe just a follow-up on neuromodulation. I think year-to-date, you're running roughly already at the midpoint of your guidance, and that does include the headwinds associated with some of the generator supply dynamics that you've talked about. I also think you're facing some replacement headwinds in the U.S. So as you contextualize the year-to-date performance in the 2025 guidance, on the neuromodulation business. How should we think about this in context of a longer-term view? And does the 5% type number represent more of a transitionary level of performance such that we can see an acceleration on the go forward.

David, it's Alex. I would say, look, we're very pleased with our performance in the first half of the year, considering the fact that we've been dealing with the Field Safety Notice. Our team has done a really good job of executing against the conversion of the SenTiva generators. And so we see positive momentum there. We -- as we talked about in the first quarter, we had -- we estimated our deferred procedures to be approximately less than $2 million. We have recaptured some of that. And now we feel bullish about our ability to recapture the balance of that this year. So we feel like this is a solid mid-single-digit growth business. And that's how we're forecasting it. As we've said all along, we believe that this is a durable mid-single-digit growth business for LivaNova.

Our next question comes from Michael Polark with Wolfe Research.

I have 1 on Essenz, and then I'm going to follow up on the epilepsy reimbursement update. So on Essenz, China launch expected in the third quarter, I know you described it as the second largest market for your HLM products. Can you be more precise what portion of the S5 base is China? And then the other China question is in the global tariff landscape, trade landscape shifting. There was news, I think, early July, China launching some restrictions on medical device imports from Europe. I have no edge on this. So can you help me understand if this is an impact for your Essenz China launch or no influence whatsoever?

Mike, Thank you for the question. So let me start with the second part of your question on trade restrictions. We're monitoring closely, we have a very capable commercial team in China, and they're executing strong versus goals. And so we don't see any meaningful negative impact and we're very confident in our ability to continue to grow in China. So this is as for your second part of the question [indiscernible] regarding China launch overall. So first of all, we're very excited that Essenz was approved in China 6 months ahead of our internal expectations, and that does indicate high demand on this product from health care system. Like you mentioned and I said China is our second largest market. And although we don't comment on exact number of units, I will tell you that we are kind of a significant market leader in HLMs in China. I spent 6 years working living and working in Asia, a lot of that, of that time was focused on China. And from my experience, Chinese market rewards differentiation, and we believe that Essenz is an innovative product and is differentiated from that point of view. So we believe that China is going to be a very strong opportunity for us to continue to drive upgrade of Essenz technology.

Helpful. And then my follow-up on the APC upgrade to Level 5 for Medicare and of service patients in epilepsy. So I guess the point that higher is better for this. I guess I'm interested to what extent you think this can positively influence providers interest in doing new patients. And so I guess the way to ask the question is from an NPI through all of the replacements that might happen, how many total events are there, mainly how many replacements does an average epilepsy patient have. I think that's the number I'm interested in today to kind of better reframe lifetime economics for a provider for this therapy?

Yes, great question. So we estimate that patients -- about 70% of patients having a first Implant will go on to have a second. And that means reimplantation rate continues to get higher of that point. So a lifetime of a patient could have anywhere up to 6, 7, 8 replacements. So this is a really meaningful step towards having a sustainable service to VNS therapy for a provider. And centers often look at their sort of total service costs across the promise spectrum. And as I said, the Medicare is approximately 40% of that for us. I do honestly believe that this will change the dynamics within our centers, and that in itself will help further penetrate certainly into new patients as well.

We now turn to David Rescott with Baird.

A follow-up on the APC code and then a follow-up on the EPS guide. But I guess, first, on this new APC code, I recall last year when there was the potential in the advisory panel for the hospital outpatient program to potentially have a lift. I believe at the time was the NPI side of the implants. There was an argument that the average kind of cranial nerve procedure that's a comparable code, had gone up over a certain period of time relative to the kind of unchanged reimbursement levels that you've seen for this code under the APC 5. And I think a lot of those devices that do have the higher reimbursement do have a higher ASP, I believe, than what you sell VNS for. So is there an argument beyond perhaps the uptake that you could see based on favorable reimbursement to leverage maybe more of a premium price here with the product? And then I don't believe that the new advisory panel for the hospital outpatient program that we saw last year has been updated yet, but I'm curious if you're expecting to maybe reapply to try to push that original Level 5 code to Level 6.

David, it's Steph here. So maybe just to go back a step. So what the proposed rule gives us with the EOS is that both MPI and U.S will be in Level 5. It just doesn't change our strategy in that, we will continue to lobby for Level 6. And Level 6 potentially will be what covers our NPI procedure. As we look ahead and certainly as we look ahead towards innovation pathway through our product development process, that's where we'll be looking to ensure that we are maximizing price. I hope that gets to your question.

Yes, that's great. And then on the updated EPS guide for the year, I know there's a bunch of moving parts in there. But when we look at the math on our end, I think you raised the EPS guide by $0.10 or so. You had a $0.18 beat in the quarter. I believe this SNIA payout is now about $0.12 lower than what was the expectation in the prior quarter. So maybe that implies that the either tariff headwind or something else is maybe $0.15 to $0.20 or so. Can you help kind of quantify just the moving pieces around the beat relative to the raise in the EPS guide for the year?

David, I will refer you to the bridge that we provided in our presentation. But at the highest level, the components that you described are the right ones. I want to call out the fact that given the strength of our first half performance, we have decided to make an investment in a PCBA upgrade conversion, which Ahmet described briefly in his remarks. This is a great opportunity for us to enhance our software to handle, call it, future revenue streams for our Essenz business. It's core to our strategy to drive growth beyond the replacement cycle. And we felt like this year, we had an opportunity to invest behind that piece of innovation. I'm going to turn it over to Ahmet, and he can probably describe this in a much more succinct way.

Sure. So as you know, perfusion today is a little bit of art where the perfusionist is the -- guiding the machine. As the leader in this market, we believe we need to change that where the machine itself is providing assistance and guidance to the perfusionist. And to be able to do that, you need a lot more processing power in the system so that you can add algorithms. And this was a planned innovation for Essenz, but due to the strength of our business, we accelerated it both due to financial strength but also our R&D capabilities improved where we can do things much faster now that enabled us to accelerate the development and upgrade Essenz. And we believe these features that we're going to have software feature is also going to drive growth because it's going to add more capability to the system and it's going to improve outcomes, and that's going to ensure that we can also monetize some of these investments because of adding new capabilities to the system.

We now turn to Adam Maeder with Piper Sandler.

Congratulations on a nice quarter. 2 for me, both on some of the pipeline initiatives. I wanted to start on TRD and the high mark coverage decision. Just hoping you could maybe double-click on that for us. Talked about some of the requirements for coverage. When did that go into effect? And anything you can kind of share at this point regarding commercial implants? And the last part of that question would just be, do you have any visibility for ongoing discussions with other commercial payers that you can talk about at this point? And then I have 1 follow-up.

Yes. I mean, today, in the United States, we have a process where you have to go through an approval with a private coverage to be implanted with VNS. And what Highmark has told us is that based on the benefits they're seeing and based on the economics, they prefer that rather than exceptions that it would be covered directly for the patient population. So Highmark and we're going to work together to remove that exception process so that it will be covered. Now we are very excited about because Highmark Blue Shield Blue Cross is a group that other Blue Cross Blue Shield groups look as well, and they are more on the kind of front end of things. But we are generally working obviously together with private coverage, private insurance groups to ensure that we have more broad coverage with VNS. But at this point, I don't think I can comment which would be next and what will be next steps. But we're working very closely with all of them, and we're working closely with them because of this exception process that we use today to get coverage for the select patients.

Okay. Understood. That's helpful color, Ahmet. And the other question I wanted to ask was regarding the obstructive sleep apnea program. And just wondering if the company has updated thoughts around path forward there, whether it's going added along with the direct sales force, in commercializing or potentially using a commercial partner. And yes, I just would love any color around the market strategy for the OSA initiative.

Adam, thank you. So first of all, let me start that we are confident in our ability to commercialize this portfolio internally. But at the same time, we are still open to a possibility of partnership if we believe that the arrangement can be beneficial to both parties. Now where is my confidence coming from in our ability to execute this lunch. First of all, I would say this is -- we believe that this is a clinically differentiated product that allows us to treat broader population, including the most difficult CCC patients. This is a technology that utilizes a differentiated modalities and new therapeutic modality with p-HGNS, proximal HGNS, that gives us kind of a strong foundation that also uses 6 electrodes, which is, again, which is differentiation. So that by itself, we believe, gives us enough differentiation opportunity for our commercial model. And then finally, we will build our expertise in neuromodulation. We will leverage our expertise in manufacturing, in R&D and clinical regulatory reimbursement capabilities that we already have in house. And again, that -- so this differentiation and our current capabilities give us confidence to -- in the ability to commercialize this internally. We will give a more precise update on our plans during the Investor Day.

We now have Matt Taylor with Jefferies.

This is Matthew on for Matt Taylor. I just had a quick one and hoping you can help walk us through some of your latest expectations for the launch in China, particularly -- to what extent is the upper revision in your guide driven by, I guess, stronger-than-anticipated commercialization? Or is there anything else you'd call out in CP that led to the raise?

Yes. So on the CP business, we're guiding to double-digit growth in the second half of the year, which is consistent with our double- digit growth in the first half of the year. We're looking at kind of 2 significant factors to watch out. The first 1 -- and we talked about both of them. The first one is the rollout and the launch of Essenz in China, specifically our ability to maintain the premium. And I think the way the team is progressing, really the price premium and the team is progressing very well. And then on the consumables side, this is unrelated. So this obviously on oxygenator output of a supply, we are executing well, and we are monitoring our continued share gain journey and also working very closely with third-party suppliers to make sure that we can continue to increase our output. So those 2 factors, I think I want to watch as kind of opportunities for additional growth in second half of the year.

Our final question today comes from Matt Miksic with Barclays.

You covered a lot here, but I thought it might be helpful just to maybe talk about sort of the growth model for cardiopulmonary just because you're obviously punching way above the level than most folks I think would suggest or think about or for this category of procedures. Can you talk a little bit about maybe break down the mix or the system placements and the consumable placement or something that will help us understand the shape of this growth? Is this like a 2- or 3-quarter phase and then we annualize or are you leaning into systems and placements and market position in such a way that as utilization goes up, we're going to see a kind of a longer wave of growth that might go 2 or 3 years, not to get too far ahead of ourselves. But that kind of color, I think, would be super helpful. And congrats on the great results and all the great data and coverage advancements.

Matt, good to hear from you. Look, I would -- great question. I would start by the fact that versus a year ago, my confidence in durability of growth in this business has increased. And if I say -- if I kind of pinpoint on why are we now guiding significantly higher than our original forecast is due to the fact that all the growth cylinders are firing very strongly. First is market growing procedures -- in terms of procedures continues to perform healthy. Our upgrade on Essenz has gone as planned and we're able to maintain price premium at a consistent level as we did last year. So to remind you, we will be 60% of all units placed this year will be Essenz. Next year, we plan for 80% and then the year after 100%. So that gives us kind of outside of this year, additional 2 years of just growth momentum in Essenz, driven by the upgrade rollout. Beyond that, like Ahmet talked about, we will start monetizing our software and service, and that will continue to drive our growth. So that's the first one. The second growth driver has been share gains in oxygenators. And short term, like I said, we have increased our market share from around 30% to around 40%. We see this momentum continue, right? We continue to invest in our output. We continue to see a lack of competitive activity in this area. And then beyond kind of the next couple of years, we are looking at a new generation launch in oxygenates that is clinically differentiated, and that will kind of trigger growth mid and long term. And then the last significant goal opportunity for us this year has been execution of our pricing strategies. And like I said before, I think LivaNova has really benchmark pricing capabilities, and we'll continue to execute it well and it kind of remains another growth driver. So in summary, the 4 growth drivers of strong procedure growth, Essenz upgrade market share gain in cardiopulmonary consumables and pricing strategies give us that confidence of durability in our growth in cardiopulmonary business moving forward.

That's all the time we have for questions, and I'll hand back to Vladimir Makatsaria for any final remarks.

All right, everybody. Thank you very much for a thoughtful questions. Thank you very much for joining us today and for your interest in LivaNova. And on behalf of the entire team, we appreciate your support and interest in LivaNova, and have a great day ahead. Thank you.

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