LivaNova - Earnings Call - Q2 2025

Executive Summary

• Q2 delivered double-digit revenue growth and margin expansion: net revenue $352.5M (+10.7% reported; +9.3% CC; +10.3% organic), adjusted EPS $1.05, and adjusted operating margin 21.9%.
• Results beat S&P Global consensus on both revenue and EPS; guidance was raised for 2025 revenue (CC: 8–9%; organic: 9–10%), adjusted EPS ($3.70–$3.80), and adjusted FCF ($140–$160M)*.
• Strength was broad-based: Cardiopulmonary +14.7% to $199.3M, driven by consumables and Essenz heart-lung machine sales; Neuromodulation +6.2% to $151.7M, with growth across regions.
• Strategic catalysts: CMS reconsideration process initiated for VNS Therapy in treatment‑resistant depression; CORE‑VNS 24/36‑month data reinforced long‑term efficacy in epilepsy, supporting the neuromodulation thesis.

What Went Well and What Went Wrong

What Went Well

• Broad-based top-line outperformance with operating leverage: revenue +10.7% reported/+10.3% organic; adjusted operating income $77.4M (vs $66.9M) and adjusted EPS $1.05 (vs $0.93).
• Cardiopulmonary momentum: +14.7% with strong consumables demand and Essenz system sales across all regions.
• Management confidence and clinical/regulatory progress: “strong revenue growth… continued operating margin expansion and strong cash generation,” with investments behind core businesses; milestones in OSA and difficult‑to‑treat depression (DTD) per CEO Vladimir Makatsaria.

What Went Wrong

• Legal and regulatory burdens remain elevated, including SNIA environmental liability and 3T Heater‑Cooler/cybersecurity/MDR-related costs captured in non-GAAP adjustments.
• DTD revenue outlook reduced to ~$10M for FY25 (from $11.5–$12.5M prior), implying a slower near-term revenue ramp in TRD pending reimbursement progress.
• “Other Revenue” declined to $1.6M (from $2.0M) as ACS wind-down fully laps, a minor headwind to total growth.

Transcript

Speaker 5

Good day, ladies and gentlemen, and welcome to the LivaNova PLC second quarter 2025 earnings conference call. If you would like to register your questions during today's event, please press star one on your telephone keypad. 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.

Speaker 4

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 Glazer, 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 complimentary 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.

Speaker 0

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 outcomes further validate early and sustained reductions in seizure frequency across multiple seizure types, including the most severe and disabling seizures. For example, the 36-month data analysis showed a median seizure reduction of 80% in patients with focal onset seizures with impaired awareness and 95% in those with focal to bilateral tonic-clonic seizures. 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 five peer-reviewed publications from the RECOVER study and strong 24-month outcomes demonstrating the durability of VNS Therapy in the severely ill patient population. In obstructive sleep apnea, or OSA, our advancing program continues to represent a significant long-term growth opportunity for LivaNova. Our submission with the FDA is progressing, and we remain confident in the ability of our differentiated neurostimulation modality called proximal hypoglossal nerve stimulation, or PHGNS. This is a new therapeutic modality with the potential to treat a wide range of challenging patients, including those with high apnea-hypopnea index, high body mass index, and complete concentric collapse. We're excited for the PHGNS to utilize a new therapeutic modality and have a positive impact on patients with sleep apnea. These achievements underscore the strength of our team and our ability to execute across clinical, regulatory, and operational priorities.

We remain focused on delivering life-changing therapies to large patient populations with significant unmet needs. For the remainder of the call, I will discuss our second quarter segment results and updates to our revenue guidance for the full year 2025. After my comments, Ahmet will discuss our recent clinical and regulatory achievements. Alex will then provide additional details on our results and updated 2025 guidance. I will wrap up with closing remarks before moving to Q&A. Now, turning to segment results. For the cardiopulmonary segment, revenue was $199 million in the quarter, an increase of 13% versus the second quarter of 2024. Heart-lung machine revenue grew in the low double digits versus the prior year period. Essenz placements increased on both a year-over-year and sequential basis and sustained favorable price premiums. Oxygenator revenue grew in the low double digits, driven by procedure growth, market share gains, and price.

Strong demand for oxygenators is outpacing the market's ability to supply. While our manufacturing capacity expansion plans are progressing well and remain on track, third-party supply is a limiting factor for even more rapid expansion. Our team remains focused on working with suppliers to meet our production needs. We now expect cardiopulmonary revenue to grow 12% to 13% for the full year 2025, up from 9% to 10% previously. Our revised forecast assumes continued HLM growth as we launch Essenz in new markets and increase penetration in existing markets. Notably, we anticipate launching Essenz in China in the third quarter, which is our second largest market for HLMs after the U.S. We still expect Essenz to represent approximately 60% of our annual HLM units placement in 2025, up from 40% in 2024. Our forecast reflects a robust demand for consumables.

Turning to epilepsy, revenue increased 6% versus the second quarter of 2024, with growth across all regions. Epilepsy revenue in the Europe and rest of the world regions increased a combined 9% versus the prior year period, while U.S. epilepsy revenue increased 5% year over year. We are pleased with a strong commercial execution globally. Specifically, in the U.S., the field safety identification process was managed very well, accompanied by a successful transition to the updated Sentiva generator, while also meeting market demand. We fully completed the inventory swap in the U.S. faster than we anticipated, mitigating potential procedure deferrals and recapturing some previously delayed implants. We expect updated generators to be available for distribution in most other major geographies during the second half of 2025 as regulatory approvals are received.

For the full year 2025, we now expect epilepsy revenue growth of 4.5% to 5.5%, up from 4% to 5% previously. Our forecast now incorporates mid-single-digit growth in the U.S., up from low single digits previously, given the faster-than-expected inventory swap and increased visibility into deferred procedure recapture. Our outlook assumes the Europe and rest of the world regions will grow a combined low double digits for the year, consistent with the prior guidance. We continue to see momentum in our global epilepsy business across volume, price, and mix, and we feel confident in our ability to achieve mid-single-digit growth this year. Looking ahead, we're pleased with the recent CMS recommendation to move end-of-service or EOS procedures from Level 4 into a Level 5 Ambulatory Payment Classification, or APC code. Assigning EOS to Level 5 would increase reimbursement support for hospitals providing VNS Therapy to Medicare patients.

If finalized, this change would take effect January 1, 2026, and provide outpatient facilities with higher reimbursement for VNS Therapy EOS procedures under Medicare. The proposed 48% increase in reimbursement for EOS procedures would meaningfully improve hospital economics over the lifetime of therapy for patients with DRE, leading to a more sustainable financial position for providers to establish and maintain a long-term VNS Therapy practice. This proposal aligns with our market access strategy to drive greater VNS Therapy adoption where a significant clinical unmet need still exists. In summary, due to the strong growth we saw in the quarter, as well as the sustained success for the Essenz rollout, market share gains in cardiopulmonary consumables, commercial execution in epilepsy, and pricing strategy, we're raising our overall organic growth outlook by 200 basis points to between 9% and 10%.

Alex will provide additional details on our 2025 guidance later in the call. With that, I'll turn the call over to Ahmet to provide an update on our recent clinical and regulatory achievements in epilepsy and DTD, progress in OSA, and an opportunity to advance HLM innovation. Thanks, Vlad. 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 anti-seizure medications and had a median of four 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 three months after implantation, followed by further substantial reduction at the 12, 24, and 36-month study visits. 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 the significantly underpenetrated DRE 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 five peer-reviewed publications from the RECOVER study. The fifth critical paper, which was recently published in the Journal of Clinical Psychiatry, demonstrates that patients with previous electroconvulsive therapy or transcranial magnetic stimulation treatment had statistically significant and clinically meaningful benefits with VNS Therapy versus the control arm. Notably, VNS Therapy is the only treatment that has demonstrated therapeutic effects in patients that previously failed electroconvulsive therapy. In addition, the strong 24-month outcome demonstrated significant durability of VNS Therapy over time and further validates its impact in this severely ill patient population.

Specifically, among the patients who achieved clinically meaningful benefit at 12 months, the median durability of benefit across all the outcome measures was 81.3% at 24 months. This demonstrates significant durability for these unipolar patients who, at baseline in the RECOVER study, had failed more than 13 antidepressant treatments on average. Observing all VNS Therapy patients in the after-treatment arm of the RECOVER trial from month 12 to month 24, researchers also found improvements in all outcome measures, with the median rate of response or clinically meaningful benefit increasing from 40.2% at month 12 to 51.6% at month 24. Notably, we are not aware of any evidence in the literature of any other therapies that can claim this profound level of sustained durability and increasing benefits, including pharmacotherapies or interventional therapies, such as electroconvulsive therapy or transcranial magnetic stimulation.

Additionally, we are encouraged by the composite suicidality data, which showed an estimated 43% higher odds of achieving meaningful improvement in suicidal symptoms versus the control arm through the first 12 months of the RECOVER study. Importantly, there was separation between the active and control arms on this metric as early as month 3, and the observed separation was consistent throughout the 12 months. The composite suicidality data will be incorporated into our formal CMS submission upon publication in a peer-reviewed journal. As we have done throughout the RECOVER program, we continue to closely partner with CMS through the Coverage with Evidence Development Framework as we progress through the coverage reconsideration. LivaNova is focused on developing clinical evidence that supports VNS Therapy for patients with TRD. We believe that this evidence resonates with ATPs treating these vulnerable patients and sees VNS Therapy as a viable treatment option.

In addition, we believe our growing body of evidence supports coverage and reimbursement for VNS Therapy in TRD. For example, Highmark, an insurer primarily serving the Mid-Atlantic, is now covering VNS Therapy for TRD when specific criteria are met. We view Highmark's recent decision as a positive step towards opening access for commercially insured patients. In OSA, our next-generation PHGNS technology utilizes a new therapeutic modality to serve the large and growing patient population. Our modular PMA submission is progressing with the FDA, and we look forward to sharing the complete 12-month OSPREY dataset later this year, which underscores the strength of our differentiated clinical evidence. PHGNS enables more complete control of the tongue and airway, providing the ability to treat a wide range of challenging patients, including those with high AHI, high BMI, and complete concentric collapse, or CCC, and delivers durable holistic clinical responses.

Of particular significance, our studies show that the patient population with a high risk of CCC had comparable results to the broad patient population, further underscoring the clinical potential of proximal hypoglossal nerve stimulation. Lastly, in cardiopulmonary, as we look to maximize recurring revenue stream, including equipment, service, and software, we're upgrading a critical printed circuit board assembly, or PCBA, to enable more advanced software updates, driving innovation, and delivering greater long-term value to our customers across the Essenz fleet. This new PCBA provides significant optionality to support ongoing Essenz system software updates in line with our future expansion roadmap. In summary, we're encouraged by the recent clinical and regulatory milestones achieved in epilepsy and depression, as well as our progress in the OSA program and near-term innovation opportunities in cardiopulmonary. We look forward to sharing future updates. With that, I will turn the call over to Alex.

Speaker 7

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 34%, in line with the second quarter of 2024. The year-over-year increase on a dollar basis was driven by variable costs associated with increased sales, commercial investments to support growth, as well as system infrastructure modernization to drive long-term efficiencies and scalability. Adjusted R&D expense in the second quarter was $44 million, compared to $41 million in the second quarter of 2024. R&D as a percent of net revenue was 13%, in line with the second quarter of 2024. The year-over-year increase on a dollar basis was driven by increased investment in cardiopulmonary and OSA to support new product development. This expenditure was partially offset by cost optimization of the DTD program as we pursue CMS coverage.

Adjusted operating income was $77 million, compared to $67 million in the second quarter of 2024. Adjusted operating income margin was 22%, compared to 21% in the second quarter of 2024. This increase was primarily driven by higher revenue and optimization of DTD program spend. Adjusted effective tax rate in the quarter was 22%, compared to 21% in the second quarter of 2024. The increase was related to changes in geographic mix and a rolloff of certain tax attributes that have contributed to our historically low effective tax rate. Adjusted diluted earnings per share was $1.05, compared to $0.93 in the second quarter of 2024. The increase was primarily driven by adjusted operating income growth. Our cash balance at June 30 was $594 million, up from $429 million at year-end 2024.

This increase primarily reflects the reclassification of $295 million of restricted cash due to the termination of the collateral cash deposit associated with the SNEEL litigation guarantee. Total debt at June 30 was $431 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 half was $68 million, up from $53 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 half was $26 million, compared to $19 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 our performance to date, we're increasing our full year 2025 revenue, adjusted earnings per share, and adjusted free cash flow guidance. We now forecast 2025 revenue growth between 8% and 9% on a constant currency basis and between 9% and 10% on an organic basis. The impact of foreign currency is now expected to be a tailwind of approximately 1%. We have revised our full year adjusted effective tax rate to approximately 23%, which represents an increase of 200 basis points versus 2024. The 100 basis point improvement versus our prior guidance is reflective of our ongoing tax optimization efforts. To reflect the stronger operational performance in our business, we now project adjusted diluted earnings per share in the range of $3.70 to $3.80, 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 favorable net interest expense due to the timing of the SNEEL liability payment. This 10% increase includes an investment in the Essenz PCBA conversion, which we expect to impact cost of goods in the fourth quarter of this year. As Ahmet mentioned, the PCBA investment will support future advanced Essenz software updates. Please refer to the adjusted diluted EPS guidance bridge on slide 17 in the investor presentation. Adjusted free cash flow is now expected to be in the range of $140 to $160 million, which is $5 million higher compared to our prior guidance due to higher income expectations as well as working capital improvements. This range includes approximately $95 million of capital spend, up from $90 million in the prior guide, driven by critical investments in IT infrastructure, innovation, and growth, including the cardiopulmonary capacity expansion initiatives.

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 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. We continue to 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, though we acknowledge the environment remains uncertain. In summary, we had another quarter of strong execution marked by double-digit organic revenue growth, which drove 90 basis points of operating margin expansion, a 13% increase in adjusted diluted earnings per share, and improvement in cash generation.

Our updated 2025 guidance reflects the strength of our underlying performance and continued investment in our core business and innovation pipeline. With that, I'll turn the call back over to Vlad.

Speaker 0

Thank you, Alex. In conclusion, we're 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're excited about our advancing OSA program, which represents a significant long-term opportunity for LivaNova. We're making important progress towards CMS reimbursement reconsideration in difficult-to-treat depression, consistent with our strategy to extend the portfolio into a high-growth market and address large patient populations with significant unmet needs. OSA and DTD each provide meaningful and distinct opportunities to accomplish this goal. With our strong team and critical milestone achievements, we're 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.

Speaker 5

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

Good morning, everybody. 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 Tezel walked us through, and maybe help us better understand 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.

Speaker 6

Good morning, Rick. This is Ahmet. Maybe I'll start and then ask Steph to talk about the impact it will have. This was a very large study, over 800 patients, that allows us to look at subgroups as well. We obviously knew the impact that VNS Therapy has on patients, but this is the largest study to demonstrate it in a very broad population. We were particularly pleased with the three-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. That's why we only got one 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. It's a large study that has a major impact. We're very pleased with the results. I'll ask Steph to comment around the impact and the feedback she's hearing from our physician.

Speaker 2

Lovely. Thanks, Ahmet. Hi, Rick. Good to speak to you. First, I'm going to give you some sort of anecdotal feedback from the field that these results have been extremely well received so far by our investigators and also our key opinion leaders in our clinical community. 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. Some KOLs are telling us that the strength and the size of this dataset will change how they counsel patients about VNS Therapy and will likely mean they consider VNS earlier in their treatment algorithm and will also drive penetration of the therapy.

Whilst it's a little premature to comment more precisely on the impact to the business at this time, we see the clinical evidence as a key component 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. The CMS boosting or proposal to boost end-of-service procedures to Level 5 from Level 4 sounds meaningful. It sounds significant. On the good side, again, talk to us about how quickly, assuming that their proposal holds, talk about how you would take action and what that could mean for the outlook for the business in 2026, how quickly it could be impactful. 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? Thank you.

Thanks, Rick. Let me give you some background. First, we are really pleased with the CMS recommendation to move end-of-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 for EOS. As a reminder, EOS comprises 70% of our implants in the U.S., and 40% of drug-resistant epilepsy (DRE) patients are under our Medicare plans. If finalized, the change will take effect from January 2026. In terms of impact, this is still a proposal. Nevertheless, any meaningful change to alleviate cost pressure is a positive step forward to creating a more sustainable financial position for our providers that are supporting the lifetime of care for that patient with DRE.

While it's premature to comment on the exact impact, we believe if finalized, this will have a very positive impact on procedure penetration. We in the team remain highly confident and optimistic that the proposal will be finalized. If we think a little bit about Level 6, 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 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.

Speaker 5

Thank you for the detailed response. We now turn to David Roman with Goldman Sachs. Your line is open. Please go ahead.

Thank you. Good morning, everybody. I wanted 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. I believe, and 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. Are we at a point such that the capacity continues to chase the demand, and what are the factors influencing that?

Speaker 0

David, good morning. Thank you for the question. First of all, let me start by saying that we see very healthy procedure growth levels elevated from historical rates. 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 have moved our market share from low 30s to now very high 30s in terms of percentage. We estimate that we've benefited from our market share gains, which came from both market growth and gaining some of the share from the competitors. That's number two. We see that strong momentum continue moving forward. Now, if I move into the supply from the market, the supply is not catching up with demand.

I think the market was a couple of years ago caught by surprise a little bit on the procedure growth elevation. We have been working hard to improve our capacity and output. Last year, we've increased our output by 10%. That was driven by improved processes and an increased number of shifts. This year, we continue to improve our processes and shifts. At the same time, our suppliers have invested in an extension of their capacity. We estimate that this year will be somewhere in the high single-digit output growth versus last year. Next year, we are adding another manufacturing line that is tracking well, and we anticipate another significant improvement in the output next year. Our comment in the remarks regarding third-party suppliers and our capacity means that we have built capacity ahead of our 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. Net is what we continue to gain share, and we don't see too much differentiated activity from our competitors in this case.

Very helpful. Maybe just to 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. As you contextualize the year-to-date performance and the 2025 guidance on the neuromodulation business, how should we think about this in context of a longer-term view? Does the 5% type number represent more of a transitionary level of performance such that we can see an acceleration on the go-forward?

Speaker 7

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 we see positive momentum there. As we talked about in the first quarter, 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. We feel like this is a solid mid-single-digit growth business, and that's how we're forecasting it. As we settle along, we believe that this is a durable mid-single-digit growth business for LivaNova.

I agree. We'll look to the next updates at the analyst meeting.

Speaker 5

Our next question comes from Michael Pollock with Wolfe Research. Your line is open. Please go ahead.

Hi, good morning. I have one on Essenz, and then I'm going to follow up on the epilepsy reimbursement update. On Essenz, a China launch expected in the third quarter. I know you've described it as the second largest market for your HLM products. Can you be more precise? What portion of the S5 base is China? 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. Can you help me understand if this is an impact for your Essenz China launch or no influence whatsoever? Thank you.

Speaker 0

Mike, good morning. Thank you for the question. 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. We don't see any meaningful negative impact. We're very confident in our ability to continue to grow in China. This is for your second part of the question. Regarding China launch overall, first of all, we're very excited that Essenz was approved in China, six months ahead of our internal expectations. That does indicate high demand on this product from the healthcare system. Like you mentioned and I've said, China is our second largest market. Although we don't comment on exact number of units, I will tell you that we are a kind of a significant market leader in HLMs in China. I spent six years living and working in Asia.

A lot of that time was focused on China. From my experience, the Chinese market rewards differentiation. We believe that Essenz is an innovative product and is differentiated from that point of view. We believe that China is going to be a very strong opportunity for us to continue to drive upgrade of Essenz technology.

Helpful. My follow-up on the APC upgrade to Level 5 for Medicare end-of-service patients in epilepsy. I get 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. 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. Thank you.

Speaker 2

Thanks, Mike. Great question. We estimate that about 70% of patients having the first implant will go on to have a second. That reimplantation rate continues to get higher after that point. A lifetime of a patient could have anywhere up to six, seven, eight replacements. This is a really meaningful step towards having a sustainable service for VNS Therapy for a provider. Centers often look at their total service cost across the prior spectrum. As I've said, 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.

Thank you.

Speaker 5

We now turn to David Rescott with Baird. Your line is open. Please go ahead.

Oh, great. Thanks for taking the questions. I had a follow-up on the APC code and then a follow-up on the EPS guide. 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 it was the NPI side of the implants. There was an argument that the average kind of cranial nerve procedure, that 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. 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.

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? 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 the Level 6.

Speaker 2

Hi, David. It's Steph here. Maybe just to go back a step. What the proposed rule gives us with EOS is that both NPI and EOS will be in Level 5. It just doesn't change our strategy in that we will continue to lobby for Level 6. Level 6 essentially will be what covers our NPI procedure. As we look ahead, and certainly as we look ahead towards our 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.

Yep, that's great. Thank you. On the updated EPS guide for the year, I know there's a bunch of moving parts in there, but when we look at kind of the math on our end, I think you raised the EPS guide by $0.10 or so. You had an $0.18 beat in the quarter. I believe the SNEEL payout is now about $0.12 lower than what was the expectation in the prior quarter. Maybe that implies that 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? Thank you.

Speaker 7

Hi, David. I will refer you to the bridge that we provided in our presentation. 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, you know, call it future revenue streams for our Essenz business. It's core to our strategy to drive growth beyond the replacement cycle. 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.

Speaker 0

Sure. As you know, perfusion today is a little bit of art where the perfusionist is 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. To be able to do that, you need a lot more processing power in the system so that you can add algorithms. This was a planned innovation for Essenz, but due to the strength of our business, we accelerated it both due to financial strength and also our new capabilities improved where we can do things much faster now. That enabled us to accelerate the development and upgrade Essenz.

We believe these features that we're going to add, software features, are also going to drive growth because it's going to add more capabilities 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.

Speaker 5

We now turn to Adam Nader with Piper Sandler. Your line is open. Please go ahead.

Hi, good morning. Congratulations on the next quarter, and thank you for taking the questions. Two for me, both on some of the pipeline initiatives. I wanted to start on DTD and the Highmark 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? Anything you can kind of share at this point regarding commercial implants? The last part of that question would just be, do you have any visibility or ongoing discussions with other commercial payers that you can talk about at this point? I have one follow-up. Thanks.

Speaker 0

Yeah, I mean, today in the U.S., we have a process where you have to go through an approval with a private coverage to be implanted with VNS Therapy. 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. Highmark and LivaNova work together to remove that exception process so that it will be covered. We are very excited about it because Highmark Blue Cross Blue Shield is a group that other Blue Cross Blue Shield groups look at as well. They're more on the kind of front end of things. We are generally working, obviously, together with private coverage, private insurance groups to ensure that we have more broad coverage with VNS Therapy.

At this point, I don't think I can comment which group would be next and what will be next steps. We're working very closely with all of them. 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 on it. Thanks for that. The other question that 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, you know, going at it alone with the direct sales force and commercializing or potentially, you know, using a commercial partner. I just would love any color around the market strategy for the OSA initiative. Thank you.

Adam, thank you. First of all, let me start that we are confident in our ability to commercialize this portfolio internally. 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 launch? First of all, I would say we believe that this is a clinically differentiated product, and it allows us to treat broader populations, including the most difficult triple C patients. This is a technology that utilizes a differentiated modality, a new therapeutic modality with PHGNS, proximal hypoglossal nerve stimulation, that gives us kind of a strong foundation and also uses six electrodes, which is, again, which is differentiation. That by itself, we believe, gives us enough differentiation opportunity for our commercial model.

Finally, you know, we will build on our expertise in neuromodulation. You know, we will leverage our expertise in manufacturing and R&D and clinical regulatory reimbursement capabilities that we already have in-house. This differentiation and our current capabilities give us confidence in the ability to commercialize this internally. We will give a more precise update on our plans during the investor day.

Speaker 5

We now turn to Matt Taylor with Jefferies. Your line is open. Please go ahead.

Hi, good morning. This is Matthew Dodds of Matt Taylor. Thanks for taking our question. 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 upward revision in your guide driven by, I guess, stronger than anticipated commercialization? Is there anything else you'd call out in cardiopulmonary that led to the raise?

Speaker 0

Yeah, 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 two significant factors to watch out. The first one, 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. I think the team is progressing really price premium, and the team is progressing very well. On the consumable side, this is unrelated to this, obviously, on oxygenator output of 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.

Those two factors, I think, are the ones to watch as kind of opportunities for additional growth in the second half of the year.

Speaker 5

Our final question today comes from Matt Mixic with Barclays. Your line is open. Please go ahead.

Thanks, Alex, for taking the question. Covered a lot here, but I thought it might be helpful just to maybe talk about sort of the growth model for cardiopulmonary because you're obviously punching way above the level that most folks, I think, would suggest or think about for this category of procedures. Can you talk a little bit about maybe break down the mix or the system placement and the consumable placement or something that'll help us understand, you know, the shape of this growth? Is this like a two or three-quarter phase and then we annualize, or are you leaning into systems and placements and market position in such a way that, you know, as utilization goes up, we're going to see a kind of a longer wave of growth that might go two or three years on not to get, you know, too far ahead of ourselves?

That kind of color, I think, would be super helpful. Congrats on the great results and all the great data and coverage advancements. Thanks.

Speaker 0

Yeah, good morning. Good to hear from you. Great question. I would start by the fact that, you know, versus a year ago, my confidence in durability of growth in this business has increased. If I kind of pinpoint on why are we now guiding significantly higher than our original forecast, it is due to the fact that all the growth cylinders are firing very strongly. First is market growing. In terms of procedures, it continues to perform healthy. Our upgrade on Essenz is going as planned, and we're able to maintain price premium at a consistent level as we did last year. To remind you, 60% of all units placed this year will be Essenz. Next year, we plan for 80%, and then the year after, 100%.

That gives us, kind of outside of this year, additional two 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. That's the first one. The second growth driver had been our share gains in oxygenators. Short term, you know, 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. Beyond kind of the next couple of years, we are looking at a new generation launch in oxygenators that is clinically differentiated and that will kind of trigger growth mid and long term.

The last significant growth opportunity for us this year has been execution of our pricing strategies. Like I said before, I think LivaNova has really benchmarked pricing capabilities, and we continue to execute it well. It kind of remains another growth driver. In summary, the four 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.

Speaker 5

That's all the time we have for questions. I'll now hand back to Vladimir Makatsaria for any final. All right, everybody, thank you. Thank you very much for thoughtful questions. Thank you very much for joining us today and for your interest in LivaNova. On behalf of the entire team, we appreciate your support and interest in LivaNova. Have a great day ahead. Thank you.

Speaker 4

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