LivaNova PLC

Good day, ladies and gentlemen, and welcome to the Levenova PLC First Quarter 2026 Earnings Conference Call. If you would like to register a question during today's event, please press star 1 on your telephone keypad. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Ms. Brianna Gotland, Levenova's Vice President of Investor Relations. Please go ahead.

Thank you and welcome to our conference call and webcast discussing Leva Nova's financial results for the first quarter of 2026. Joining me on today's call are Vladimir Makatsaria, our Chief Executive Officer and member of the Board of Directors, Alex Schwartzberg, our Chief Financial Officer, and Ahmet Tuzel, our Chief Innovation Officer. 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 basis. Reconciliations to the most directly comparable GAAP financial measures can be found in today's press release, which is available on our website. We have also posted a presentation to our website that summarizes the points of today's call. This presentation is complementary to the other call materials and should be used as an enhanced communication tool. You can find the presentation and press release in the investor section of our website under news events and presentations at investor.livanova.com. With that, I'll turn the call over to Vlad.

Thank you, Brianna, and thank you everyone for joining us today. Welcome to Livanova's conference call for the first quarter of 2026. In the quarter, Livanova delivered 11% revenue growth with strength across all regions, driven by durable performance in our cardiopulmonary and epilepsy businesses. Our core businesses continue to serve as both the drivers of current performance and enablers of discipline, investment and innovation. We expect these investments to fuel the long term durability of our core performance, as well as expansion into high growth, high margin markets to build a more sustainable financial profile for value creation over time. One such market is obstructive sleep apnea. We continue to view the OSA market as attractive. Up to 1 million patients drop out of CPAP treatment annually, and the HGNS penetration into that population is less than 5%, which creates a significant opportunity. We recognize that there are current challenges in the HGNS market. but view the current dynamic and ambiguity in reimbursement as temporary and the long-term effect of GLP-1s on the market as net positive. With PHGNS, we have a clear right to win supported by rigorous clinical evidence and differentiated technology designed for broader and more complex patient population and leading neuromodulation capabilities across Livanova. We recently achieved key regulatory and clinical milestones, establishing a strong foundation for our planned entry into the OSA market next year. The first of these milestones occurred in March when Livanova received US FDA pre-market approval for the Aura 6000 system for the treatment of adult patients with moderate to severe OSA. Notably, This is the first and only hypoglossal nerve stimulation device approved by the FDA without a complete consent to collapse, counter-indication or warning. The second important OSA milestone is on the clinical evidence front where the full 12 months results from our Osprey randomized control trial were recently published in the annals of internal medicine, demonstrating clinically meaningful responses and sustained improvements over time. Ahmed will share additional details later in the call on how we're leveraging these milestones to advance our OSA program. For the remainder of the call, I will discuss our first quarter segment results and provide updated top line guidance for 2026. After my comments, Ahmed will discuss key innovation updates, including recent regulatory and clinical progress. Alex will then provide additional details on our results and updated 2026 guidance. I will wrap up with closing remarks before moving on to Q&A. Now turning to segment results. For the cardiopulmonary segment, revenue was $209 million in the quarter, an increase of 14% versus the first quarter of 2025. Heart-lung machine revenue grew in the high teens in the quarter, driven by an increase in essence placements on both a sequential and year-over-year basis, and sustained favorable price premiums. The results for the quarter also included a modest benefit from the recapture of essence placements and tenders that were previously deferred from the fourth quarter of 2025. The performance was otherwise driven by underlying demand and the associated favorable price mix effect. Cardiopulmonary consumables revenue grew in the mid-teens in the quarter. driven by the market share gains, procedure growth, and price. While demand for oxygenators continues to outpace the market's ability to supply, improvements in the third-party component availability has enabled us to increase our manufacturing output. For the full year, 2026, we now expect cardiopulmonary revenue to grow eight and a half to 9.5%, up from 7% to 8% previously. Our forecast reflects continued HLM growth as we drive essence penetration globally. We still expect essence to represent approximately 80% of annual HLM unit placement in 2026, up from 55% in 2025. This forecast assumes continued market share gains in consumables as we execute on our manufacturing expansion plans. Within this guidance, we expect our full year manufacturing output to increase by low double digits, driven by a new manufacturing line scheduled to go live in the second half of the year. This represents a significant acceleration versus 2025 levels additionally we'll continue to work with third-party suppliers to increase component availability which could enable additional oxygenator output growth beyond current assumptions turning to epilepsy revenue increased eight percent versus the first quarter of 2025 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 U.S. epilepsy revenue increased 7% year over year. Performance was driven by total implant growth and favorable realized price supported by impactful clinical evidence, improved reimbursement, and sustained commercial excellence. Consistent with what we have shared previously, the results from our core VNS study have been well received by key opinion leaders and have become an important component of our commercial engagement and education efforts. In recent conversations in our inaugural VNS forum, which brought together approximately 150 clinicians, participants shared that the data is reshaping their perception of the effectiveness of BNS therapy for epilepsy. They also indicated that the findings support broader adoption as they reevaluate the therapy's role within their treatment algorithms. Notably, over 50 leading experts have requested permission to independently present the data. Effective January 1st, 2026, U.S. Medicare reimbursement for VNS therapy procedures in drug resistant epilepsy increased meaningfully with hospital outpatient payments rising approximately 48% for new patient implants and 47% for end of service procedures compared to 2025 levels. These U.S. reimbursement changes improve hospital economics for VNS therapy, creating a more sustainable model for providers, and supporting expanded patient access. In the US, there are approximately 1 million GRE patients, yet fewer than 10% receive advanced treatment. The updated reimbursement rate reduced a known barrier to procedure penetration, as historic Medicare rates did not fully cover VNS therapy procedure costs. As a result, we saw improved realized pricing in the first quarter, driven by less volume discounting, as well as our normal annual list price increase. For the full year 2026, we now expect epilepsy revenue growth of 6% to 7%. up from 5.5% to 6.5% previously. This forecast is driven by improved growth rates in the US, Europe, and the rest of the world. The improved outlook is supported by strong global acceptance of core VNS, as well as both reduced volume discounting and the strengthening of the patient funnel in the US, driven by improved reimbursement. In summary, Levanova's first quarter growth was driven by healthy markets, continued success of the essence upgrade cycle, sheer gains in cardiopulmonary consumables, and strong epilepsy commercial execution. We expect these drivers to sustain through 2026, supported by continued execution in cardiopulmonary and the combination of compelling clinical evidence and improved reimbursement dynamics in epilepsy, which should expand patient access over time. As a result, we're now guiding full year 2026 revenue growth between 7% and 8%, up from 6% to 7% previously. The stop-line guidance implies performance at the high end of the 2025 to 2028 growth framework we outlined at investor day. Alex will provide additional details on our 2026 guidance later in the call. With that, I'll hand the call over to Ahmed to cover the strong momentum across our innovation agenda, including recent clinical, regulatory, and digital advances across our portfolio.

Thank you, Vlad. Innovation is central to Livanova's next chapter of growth, both fueling the pipeline while strengthening our core businesses. Starting with OSA, as Vlad mentioned, Livanova recently received FDA pre-market approval for the Aura 6000 system for the treatment of adult patients with moderate to severe sleep apnea. This is a transformative milestone, both for the company and for patients who continue to face significant unmet needs. Importantly, FD approval enables broader compliant engagement with clinicians through promotion, training, and education, an essential step to building awareness and supporting appropriate utilization over time. In parallel, we're advancing the development of a next generation system designed to further benefit patients and support commercialization. We continue to expect to submit a PMA supplement for the commercial MRI compatible device in the second half of 2026. This would support a limited market release in the first half of 2027, followed by a broader commercial launch in the second half of 2027, consistent with the timeline outlined at investor day. Our PHNS therapy was rigorously evaluated for safety and effectiveness in the Osprey randomized controlled trial with 12-month results recently published in the Annals of Internal Medicine. The study demonstrated clinically significant responses and sustained improvements over time. Notably, Osprey is the first and only randomized controlled trial in the HGNS space, bringing gold standard scientific rigor to the field. It is the only HGNS study to evaluate several patient-reported outcomes, or PROs, making the findings more comprehensive than prior pivotal FDA trials. Osprey patients in the treatment cohort showed significant improvements in PROs, including the Epworth Sleepiness Scale, which measures daytime sleepiness and functional outcomes of sleep questionnaire which assess the impact of fatigue on daily activities. Collectively, Osprey's data show that for patients with moderate to severe LSA, treatment led to meaningful improvements, not only in objective disease severity, but also in daytime, sleepiness, and other PROs that matter most to patients and clinicians. As previously disclosed, Osprey did not exclude patients with complete concentric collapse with approximately 45% of the participants considered high risk. The study enrolled a challenging patient population with higher baseline AHI and BMI compared to other pivotal US trials, yet achieved comparable responder rates. We are proud to bring the option of PHGNS to more patients as the first and only FDA approved HGNS therapy without CCC-related contraindication or warning, and without a preimplantation drug-induced sleep endoscopy requirement. In addition, our PolySync evaluation is progressing. PolySync is our advanced titration algorithm that fully utilizes the six-electrode architecture of the PHNS cuff, enabling greater selectivity and patient-specific optimization of therapy. PolySync's demonstrated ability to convert non-responders into responders both strengthens our competitive positioning versus existing HGNS therapies and has the potential to expand penetration in a broader range of patients. We're excited to share the complete PolySync results at the upcoming sleep conference in June. To date, our findings indicate that polysynq will convert over 50% of Osprey non-responders into responders. For context, our study originally included roughly 100 patients who were randomized into treatment and control groups and monitored until the seven-month primary endpoint. At that point, patients in the control group also began receiving therapy. Following the 13-month endpoint, we extended the opportunity to all non-responders, regardless of their original assignment, to participate with PoliSync. This approach led to a cumulative responder rate surpassing 80% across the entire Osprey trial population. These results underscore the significant impact PoliSync may have in improving outcomes within this patient group. As a reminder, Polysync will be available at launch, enabling patients to benefit from the advanced algorithm, starting with their initial titration. We continue to view OSA as a compelling de-risked opportunity, grounded in differentiated technology and clinical evidence, as well as our established neuromodulation capabilities. Now turning to difficult to treat depression. We continue to believe VNS therapy is a differentiated option for this markedly ill patient population. While we remain in active engagement with CMS, we won't speculate on exact submission timing. We remain excited by the DTD opportunity and will continue to keep investors updated on material developments as appropriate. In epilepsy, during the first quarter, We initiated limited market release of our cloud-based clinician portal and application. As a reminder, this rollout is intended to validate workflows and deepen clinician engagement. The financial impact is expected to be limited this year. A full market release is planned for 2027 alongside the launch of our next generation Bluetooth-enabled generator. This multi-year innovation roadmap is expected to streamline care delivery through remote titration, real-time access to patient insights, and more digitally connected care pathways that remove barriers to access. At Livanova, we have developed a unified digital health platform for our entire portfolio, allowing for a consistent technology, user experience, and data strategy across our different business units. For example, in epilepsy, the cloud-based clinician portal and app will enable capabilities such as remote titration. Lastly, innovation within our CP consumables portfolio continues to advance. For our next-generation oxygenator, with the design finalized, we are now in the manufacturing scale-up phase of product development. In summary, we are encouraged by our recent progress across the portfolio, including regulatory and clinical evidence momentum in OSA and DTD, the rollout of our connected care platform in epilepsy, and the advancement of the Next Gen Auctioneer Program. Collectively, these milestones underscore the depth of our innovation pipeline and the opportunity to continue raising the standard of care. With that, I will turn the call over to Alex.

Thanks, Amit. During my portion of the call, I'll share a brief recap of the first quarter results and provide commentary on our updated full-year 2026 guidance, which reflects strong performance year-to-date and improved business outlook. Turning to results, revenue in the quarter was $362 million, an increase of 11% on a constant currency basis versus the prior year. Foreign exchange in the quarter had a favorable year-over-year impact on revenue of approximately $10 million or 3%. Adjusted gross margin as a percent of net revenue was 68% compared to 69% in the first quarter of 2025. Higher volumes and improved pricing were offset by unfavorable currency and product mix. Adjusted SG&A expense for the first quarter was $129 million compared to $116 million in the first quarter of 2025. SG&A as a percent of net revenue was 36% as compared to 37% in the first quarter of 2025. On a year-over-year basis, the reduction as a percent of net revenue was driven by fixed cost leverage. Adjusted R&D expense in the first quarter was $47 million compared to $38 million in the first quarter of 2025. R&D as a percentage of net revenue was 13% compared to 12% in the first quarter of 2025, with the year-over-year increase primarily reflecting planned investments in OSA. Adjusted operating income was $71 million compared to $65 million in the first quarter of 2025. Adjusted operating income margin of 20% was generally in line with the prior year period, reflecting higher revenue and operating leverage partially offset by increased OSA R&D investment and unfavorable foreign currency impacts. Adjusted effective tax rate for the quarter was 23% compared to 24% in the prior year period, reflecting a modestly more favorable geographic mix of income. Adjusted diluted earnings per share was 98 cents, compared to 88 cents in the first quarter of 2025. The increase was primarily driven by higher revenue, reflecting strong growth across both the cardiopulmonary and epilepsy businesses. Moving to our cash balance at March 31st. Cash was $540 million compared to $636 million at year end 2025. Total debt at March 31st was $288 million compared to $377 million at year end 2025. The reduction in both cash and total debt was a result of the early repayment of the outstanding term facilities of $98 million inclusive of accrued interest. Adjusted free cash flow for the quarter was $4 million compared to $20 million in the prior year period. The year over year decrease was primarily driven by increased capital spend and higher working capital requirements aligned with revenue growth. As a reminder, the first quarter results are disproportionately low relative to our guidance due to the payout of the 2025 accrued short-term incentive bonuses. Capital spend was $14 million in the first quarter, compared to $11 million in the prior year period. The year-over-year increase was driven by cardiopulmonary capacity expansion initiatives, the next generation oxygenator manufacturing scale-up, as well as investments in IT infrastructure. Now turning to our updated 2026 guidance. As Vlad mentioned, based on performance to date, we're increasing full year 2026 revenue and adjusted earnings per share while maintaining adjusted free cashflow guidance. We now forecast 2026 revenue growth between seven and 8% on a constant currency basis, up from six to 7% previously. We continue to expect the impact of foreign currency to be a tailwind of approximately 1% based on current exchange rates. Consistent with our prior guidance, we estimate a tariff net impact of less than $5 million on adjusted operating income for the full year. At this point, we are not assuming a tariff refund benefit. However, we are working through the government's refund process. We believe Levenover remains well positioned to manage the impact of tariffs. With respect to the conflict in the Middle East, we have incorporated an estimated full-year impact of approximately $5 million on adjusted operating income, primarily related to higher shipping, logistics, and fuel costs. As with tariffs, the situation remains dynamic and we continue to monitor developments closely. Despite this impact, we continue to expect full-year adjusted operating income margin to be in the range of 20 to 21%. Adjusted effective tax rate is still forecasted at approximately 23%. To reflect stronger operational performance, we now project adjusted diluted earnings per share in the range of $4.20 to $4.30, with adjusted diluted weighted average shares outstanding to be approximately 56 million for the full year. This CPS range represents approximately 9% growth at midpoint. Adjusted free cash flow is still expected to be in the range of 160 to $180 million. This range includes $120 million in capital spending, a $40 million increase versus the prior year. This level of investment is consistent with our Q1 initiatives, supporting cardiopulmonary capacity expansion and the next generation oxygenator manufacturing scale-up, as well as investments in IT infrastructure. In summary, we delivered strong first quarter with double-digit revenue growth, positioning us well for the balance of 2026. Our updated 2026 guidance aligns with the 2025 to 2028 framework presented at our investor day and reflects top line performance at the high end of our targeted mid to high single digit revenue CAGR. We continue to target annual adjusted operating margins above 20% with EPS growth roughly in line with revenue. Our adjusted free cash flow trajectory supports achieving 80% conversion by 2028. This outlook reflects healthy core business execution and continued disciplined investment consistent with our capital allocation framework. With that, I'll turn the call back over to Vlad.

Thank you, Alex. In closing, Livanova's strong operating model continues to generate durable growth, fueling both our performance today and our ability to invest for tomorrow. We also made important progress in OSA this quarter, achieving key regulatory and clinical milestones that position us well for entry into this high growth, high margin market. I want to thank our colleagues around the world for their focus and dedication to improving outcomes for patients and serving our customers. With a strong team and clear strategic priorities, Livanova is well positioned for continued momentum in 2026 and beyond. With that, we're ready to open this call for questions.

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 the number 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, and it really is great to see such an excellent quarter across the board. Very impressive. Well done. And just to start off, Maybe you could, Vlad, or whoever you want, expand on your very encouraging comments on what seems like a change, a new world, or the beginning of a new world for the epilepsy business post the reimbursement change. I mean, you knew it was going to be important. It seems like it really is important. Talk to us about your commercial competitive life post this and this evident pickup in terms of selling, operating, contracting, and how we think about the business going forward. I mean, it's hard not to believe you're being, I mean, I know it's early, but that you're not being very conservative and talking about the guidance and the outlook there. Thank you.

Yeah. Rick, great to hear your voice and thank you for the question. So I'll maybe start a little bit broader to say what I'm really pleased about in terms of our performance is with the quality of our growth. If I look at it geographically, we have healthy growth across all regions across the world. If I look at it from the business growth drivers, you know, kind of all the cylinders were firing. We continue to see really strong momentum in the upgrade of essence. We are accelerating in terms of share gain on oxygenators and we see strong growth in our epilepsy business driven by two factors. You know, one is improved reimbursement as of January 1st and 2nd. The dissemination of the clinical data that was an outcome of the core VNS study. And now if I focus on the epilepsy front, you know, what we expect from this two factors is number one is improvement in price. And that is a short-term improvement. It's driven by the fact that we are reducing some of the volume discounts that were given in the past. And so you kind of see that uplift in price right away. Secondly, we see an opportunity for improved penetration of VNS procedures in epilepsy, basically volume increase of procedures, and that is going to be driven by this changing algorithm within practice of current epileptologists that are doing already VNS procedures and potentially opening new centers that will to VNS procedures because now the economic barrier has been removed. So it's too early to kind of tell you what the long-term trends are. And as we continue to build our experience in this new world, we will update the investors on the progress.

Rick, I'll just add one more, a little bit more color. with the majority of the pricing changes took effect on January 1. So due to the timing of the reimbursement update in 25, you know, pricing for many of the accounts was already established for 2026. So our team will identify kind of a new tranche of customers for 27. So that will, that element will continue. We've seen traction in new and expanded and reopened accounts to date. So in the first half, you know, the teams are focused on reengaging with our ATP customers and really demand generation. So the volume-driven assumptions, including new, expanded, and reopen accounts are expected to materialize in the second half.

Gotcha. Thank you for that, Alex. And just as a second question, turning to cardiopulmonary, I mean, strong consumable quarter up mid-teens. You bumped up the 26 guidance, you know, continued HLM growth. And as always, Ulster County Transportation Council Chambers. For over the last several years you're indicating you're continuing to work with third party supply suppliers to expand auctioneer capacity. Ulster County Transportation Council Chambers. I don't know it just sounds to me like again here just the short term and longer term implications of improving third party component supply and manufacturing ramp I don't just sounds better than you, it seems better than I expected and your tone sounds more confident. Just where are we? And I mean, is there a sudden inflection or more dramatic expansion in supply ahead in the not too distant future? Just where are we in this whole process now? Thanks so much.

Thank you, Rick. Yeah, this is a critical priority for us to continue to drive our growth. We're very pleased with our recent progress in manufacturing output, and it comes from both improvements within Livanova and improvements with third party suppliers. One, you know, as we said in the opening remarks, we were guiding to a low double digit increase in output of oxygenated production this year. We have very important milestone coming in the second half of the year. where we are opening additional manufacturing line within Livanova to expand our manufacturing capacity and output even further. So it's been a positive experience for us. This is probably a source of, like we said during the investor day, of additional growth for Livanova. But I think also if I step back, and talk about the market share dynamics. Over the last couple of years, we were able to improve market share from approximately 30% to approximately 40%. You don't see that very often in such a mature market, but we continue to build our strategy to use market share as key growth lever. And so what we've guided during the investor day is that we will increase oxygenated capacity by 60% by 2030 and improve market share further by 800 basis points. So our work on manufacturing output is kind of focused on execute versus the share gain.

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

Oh, great. Thanks for taking the questions and congrats on the strong start to the year here. Maybe from us starting on the VNS bucket, appreciate the the comments you provided on that already. And it certainly sounds like, you know, the commentary specifically around, I guess, the core data and market market interest or health was more constructive maybe than we've heard in prior quarters. I know you've talked in the past about some of this limited impact maybe from from Wiser. I know there's There's others that have seen that impact out there. So just curious if at all in the quarter, you know, you saw anything there. And if so, you know, would it be fair to assume that maybe the delta versus the report results at all could be entirely driven by price? Or are you starting to maybe see some of these, you know, benefits from utilization as early as Q1 so far?

Hi, David. So, let me address the wiser question. So, in the subset that we track, we're any patients that have been denied access to VNS therapy. You know, early indications suggest that the program has had no material impact on us so far. And, you know, as we continue, we'll continue to monitor the pilots that are ongoing across the six states. You know, I'll just say one other thing, kind of an anecdote. You know, we've successfully managed several WISER submissions to date and, you know, all of which have secured approval within a 48-hour window. So, you know, just kind of at the highest level, we're not seeing much impact. And then finally, as a reminder, the majority of our Medicare patients who undergo VNS therapy are enrolled in Medicare Advantage plans. So, as such, you know, we're very familiar and already subject to the prior process. So, again, we don't see much of an impact.

Okay, perfect. Maybe on hypoglossal nerve, OSA, that the longer-term strategy there. I mean, it sounds like, you know, maybe at this point, 2028 is a period of time at which reimbursement maybe, you know, is fully ironed out. the prior goals have been for a launch at some point, maybe back half of 2027. You know, so curious around how you're thinking about not only the evidence generation and development of that strategy in 2026, but as you get into 2027, you know, if at all some of those you know, reimbursement headwinds or overhangs, we'll say, that maybe don't get fixed until 2028 influence at all how you're thinking about more of this intermediate term rollout? Thank you.

David, thank you for the question. I think maybe I'll start by saying that, I mean, we obviously follow and recognize that there are currently some challenges in the HGMS market. However, we view that current dynamic as temporary. And we still believe that the market is very attractive and this is driven by large patient population, high unmet clinical needs. And at the same time, we believe that we have the right to win with both our clinical and technological differentiation that we've discussed during the investor day and other engagements. So our view on the market has not changed and we're learning as we are preparing for launch on how to deal with some of the challenges that we believe are mainly driven by the coding and reimbursement. And then maybe I'll turn over to Ahmed to talk a little bit broader on our market access.

Yeah, I mean, we continue our approach that we will use the prevailing codes at the time of the launch. And with the incumbent removal of the sensor, the two technologies in terms of reimbursement are very similar, so we are confident that by the time we're in the market, the reimbursement issue will be settled a little bit more, and we will continue to work with AMA and other societies to ensure that we are doing this in a collaborative way. And one last thing I would say is that I do believe it is a strength of Livanova, the reimbursement piece. I think we've demonstrated that with VNS. We have a very strong team that really understands this, so we will continue to work with that team and ensure that, you know, we pursue the appropriate codes at the time of launch.

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

Hi. Good morning. Thank you for taking the questions, and congrats on a nice start to the year. Two for me, I wanted to start on HLM and a really good quarter for that product line, you know, broad-based performance by geography. Maybe you can just expand on, you know, what went well in the quarter and then also double-click on China specifically. I'm curious to kind of understand how the essence launch is going in that geography As we think about China and FY26, maybe contextualize that against the revised CP guidance, and then I had a follow-up on the Middle East. Thanks.

Adam, good morning. Great to hear your voice. Actually, I was in China with a team earlier this year. We have a very good organization there, a great leader. and the business is doing very well so the launch of hlm is progressing well in the first quarter it's progressing as planned you know we're the market leader there and and you know we continue to be very optimistic about that market for us and uh in terms of hlm performance you know while we don't disclose exact units sold in in various countries I tell you that, you know, we plan to grow essence penetration to 80% in 2025 as percent of all units placed in 2026, sorry, up from 55% last year. And China is going to play a significant role in that increase. So that's on China. And then broader on HLM, you know, we're pleased with the high teens growth in the quarter. We continue to see the success in the upgrade cycle. And what's great to see is this growth is actually driven by healthy volumes, both sequential and year-on-year basis. And secondly, I would say that it's good to see that customers are recognizing the clinical benefit of operating a machine that is fully loaded with optionality and as a consequence of that we're able to maintain significant price upside versus the previous version so this kind of this this clinical value proposition gives me a good confidence into the future that we will able to maintain that price upside yep okay that's that's very helpful vlad appreciate the color and

For the follow-up, Alex heard the commentary in the prepared remarks on Middle East. I think you said $5 million adverse impact on adjusted operating income from shipping and fuel costs. Hopefully, I heard that correct. Any color from a revenue standpoint in terms of how you're thinking about the conflict, which of the businesses are impacted, and maybe just help us better understand kind of

you arrived at those assumptions thank you yeah so from a revenue perspective adam uh middle east is represents approximately four percent of our total revenue base uh so not a significant impact um look we we operate in segments uh that are essential you know for for patients around the globe and And so we're going to continue to supply the market as best we can. In terms of the impact on EPS, we dialed in approximately, you know, $5 million or $0.07 EPS impact. It's really related to the increases we anticipate in terms of freight, logistics, and energy costs. So to no one's surprise, those are the challenges that all companies are seeing at this point in time. So we thought it was prudent to include that in our guide. And I think overall, I think we're really in a good position you know, relatively speaking, you know, in terms of managing through this Middle East conflict.

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

Hi. Good morning. Follow-up question on oxygenators. I'm curious what you're seeing on the competitive landscape regarding capacity. I hear your comments loud and clear. Sounds like pedal to metal on increasing production volume. Do you think you're alone in making those investments, or do you see evidence that competitors are trying to catch up too? Thank you.

Good morning, Mike. We see a couple of things from the competitive landscape, and this is obviously this is our view on it. we observed getting gear that continuing to exit from this space. They recently commented that they expect sales to decline from 27 million in 2025 to approximately 5 million in 2026. And majority of that will come from consumables, but as well as heater, heater, coolers and HLM. So that's that's one side. The second one is we uh don't see any uh kind of capacity expansion or investment in innovation in the space from other competitors in the space um and uh at this point you know we're focused on not just on expanding output of current oxygenators we're also focused on innovation And we believe that the next generation oxygenator will be clinically differentiated from anything on the market today.

Helpful. For a follow-up, I'm interested in a comment on the new tech APC assignment for VNS for epilepsy 1580. As we head into the summer rulemaking season, what's your base case that the code stays in that? 1580 assignment, or do you think the chances of level six creation are elevated this year? Thank you.

Hey, Mike. Yeah, so look, our market access team continues to work on, you know, getting to a level six reimbursement code. You know, we're going to continue into next year. We do, as far as our assumptions go at this point, we anticipate that the 1580 will, but we'll roll over into 2027.

We now turn to Anthony Patron with Mizuho. Your line is open. Please go ahead.

Thanks. Good morning, everyone. Congrats on the quarter here. Maybe two-part on epilepsy. Vlad, last quarter you kind of called out, you know, new accounts that were not performing, you know, VNS as a potential upside driver. Patrick Corbett, Existing accounts that can you know where you can go deeper and then prior accounts that were using DNS that stepped away from it potentially they can come back in so. Patrick Corbett, Maybe just an update on on those three buckets how you see that trending throughout the remainder of the year. Patrick Corbett, And i'll throw the follow up in here just on a generalized seizure front, you know, potentially have some competition coming in later this year. Just how do you think about the generalized seizure landscape potentially with two neuromodulation players in it? Thanks again. Congrats on a friend.

Yeah. Thank you, Anthony. And I'll start with your first part of the question and then turn to Ahmed to comment on the clinical side. On the first one, you bucketed this kind of in three type of customers, you know, so the current users. And I think that's where we start seeing an impact right away. both in terms of in some accounts potentially on reduction of discounts and in some accounts we're already starting to see an improved pipeline for MPI and that is due to the fact that obviously one is the discount side but the other side is that clinicians are starting to see VNS as a more effective therapy and they're changing the kind of the place of the therapy in the algorithm of their treatment. So that is already, we started seeing good leading indicators of this happening. For the accounts that were, that stopped doing VNS historically and potential new accounts, this is going to take some time, obviously, because it will take the accounts to set up some time to reopen and restart the procedure. So we're still confident that this is going to be a trend.

um but that will be something that we will see in the future yeah in terms of the generalized indication you know we are anticipating in the second half that fda will make a decision just to remind the scale of it only about a third of epilepsy patients are generalized two-thirds are focal and in their Less than 50% are GTC patients, so we anticipate that the impact would be very limited, and we do not anticipate any direct effect to reimbursement when we utilize patients with generalized indication as we can do today.

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

Good morning. This is Mike Sarkone on for Matt. Thanks for taking the question. Just wanted to start with a clarification on what's baked into guide on the CP side. I think you talked about increasing your manufacturing capacity, low double digits, going live in second half 26. But then you also mentioned you're continuing to work with third party suppliers. to improve component availability. Do you think you could frame, you know, how those conversations are going? And to the extent they're successful, you know, what does that mean in terms of upside to guide this year?

Hi, Mike. So our updated guidance incorporates incremental improvements in the consumable component supply. So we've seen some of that read through in Q1. And we continue to work with our suppliers. In fact, we see that potentially could drive some incremental output as upside relative to our current assumptions. The market demand continues to outpace supply, and we're still operating in the backorder situation. As we improve component supply from third party partners, we would like to see kind of a rebuild of some inventory levels because we're still kind of operating hand to mouth. And that's that's something that we're looking to improve. So we're going to continue to improve our own capacity throughout the year. We have a second line coming online in the second half of this year. And we're going to continue to partner with third-party suppliers to improve component supply. So that's what's dialed into our guide.

Got it. Thank you. And then just on DTD, you mentioned you're in active engagement with CMS. We'd love any more color there on how you feel about those conversations and just an update on your level of confidence that we could get this over the finish line.

Yeah, I mean, as you recall, we chose a very collaborative approach in the submission with CMS rather than directly submitting. We wanted to engage with them through a draft application. We continue to collaborate very well with the agency. We're looking forward to our next meeting. In terms of our confidence, I think our confidence lays behind the quality of the data, particularly the durability of treatment. As you recall, at two years, it's over 80% of the patients maintain their treatment, versus today, if there's any standoff care, it is electroconvulsive therapy where patients lose their efficacy about 50% at one year. So our confidence has not changed. We continue to collaborate well with the agency, and we will definitely update once we have a formal application.

Our next question comes from Mike Mattson with Needham and Company. Your line is open. Please go ahead.

Yes, thanks. So just with regard to the OSA launch and the investments in terms of Salesforce hiring and things like that, can you maybe give us an update on where things stand with that? It seems like you called out, if I remember correctly, called out an impact to R&D, but in the quarter R&D expense, but I didn't hear anything in terms of like sales marketing. When do you expect to start hiring salespeople and any other kind of investments you need to make there? Thanks.

Hi, Mike. So our focus this year is squarely on product development and getting the next gen device ready for launch in 2027. We expect a limited commercial release in the first half of 27 and a full launch in the second half of 27. So as far as our investments this year, still continue to focus largely on R&D with maybe a small portion on market development as we move, as we progress uh towards launch uh we'll start uh we'll start hiring uh reps probably uh late this year early uh early next year as we get get ready for a full market release in the second half yeah and then maybe okay to add a little bit of yeah go ahead yeah maybe just one comment you know we're very pleased with the fact that lucille blaze uh was our leader in osa

chose levanova should join the company and and as a leader she is now forming the leadership team the go-to-market strategy and uh i mean the question that you asked on the commercial team that obviously will be started to get executed in 2027 but all the preparation work is being done now okay got it and then i heard you also call out some some impact from um spending on the

Ramp up on the next generation oxygenator so can you just remind us on the timing on that and kind of how it will compare to the current offering and how it'll be sort of phased in will be more of a media switch over or more of a gradual change like we've seen with essence.

Yeah, in terms of the development, we're in the late stage development. And what I mean by that is that we have a completed design. We are now doing the manufacturing scale up. And we do anticipate that the product will launch in 2028, the Oxygenator. That was the question, right? Yeah. So in terms of its capabilities, You know, there's about 8 to 10 different parameters that perfusionists care about in the performance of an oxygenator, and we believe our next-gen is superior or equal to, on all those parameters, superior or equal to then the market leader product that we have with our Inspire oxygenators in the market. So we're very excited about it, and we continue to do the late-stage manufacturing scale-up.

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

Well, thank you, everybody, for your engagement, for Livanova for joining us today. And on behalf of the entire team, we really appreciate your support and interest in the company. Have a great day.

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