8/5/2026

speaker
Operator
Conference Operator

Good day, ladies and gentlemen, and welcome to the LevaNova PLC second quarter 2026 earnings call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. As a reminder, this conference call is being recorded. I would now like to introduce you to your host for today's conference, Ms. Briana Gotlin, LevaNova's Vice President of Investor Relations. Briana, please go ahead.

speaker
Briana Gotlin
Vice President of Investor Relations

Thank you and welcome to our conference call and webcast discussing LevaNova's financial results for the second quarter of 2026. 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, and Ahmet Tezel, 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. 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. Thank you, Briana. And thank you, everyone, for joining us today.

speaker
Vladimir Makatsaria
Chief Executive Officer & Member of the Board of Directors

Welcome to LiveANova's conference call for the second quarter of 2026. Before reviewing our strong quarterly performance, I would like to begin by recognizing something fundamental to LiveANova's long-term success. Exceptional people deliver strong results. Over the past several months, we have continued to strengthen our leadership team while also honoring leaders whose contributions helped shape the company we are today. I want to recognize Franco Paletti, who recently retired after more than 40 years with Livanova. Franco has been instrumental in building our cardiopulmonary business into a global leader. with lasting contributions across innovation, operations, and culture. On behalf of the entire company, thank you Franco for four decades of extraordinary leadership. It is my pleasure to share that Stefano Folli has joined Livanova as president of our cardiopulmonary business. Stefano joins our experienced CP team after a distinguished career with Philips, where he most recently served as executive vice president, global president, ambulatory monitoring, and diagnostics. He brings deep industry expertise and strong commitment to advancing our strategy for customers and patients worldwide. Over the past few months, Franco and Stefano have been working closely together on a smooth transition, ensuring our continued momentum into the next chapter of our cardiopulmonary business. I'd also like to welcome Anne Liddy, our new chief legal officer, who joins us from Hologic, where she most recently served as general counsel. Anne is an accomplished global executive whose extensive legal compliance and business leadership experience combined with her deep background in healthcare will be instrumental as we position the company for its next phase of growth. We look forward to her joining us later this month. For the remainder of the call, I will discuss our second quarter results and provide updated top-line guidance for 2026. After my comments, Ahmet will discuss key innovation updates and Alex will then provide additional details on our results and updated 2026 guidance. I will wrap up with closing remarks before moving to Q&A. We delivered a strong quarter of double-digit reported revenue growth with strength across all regions driven by robust performance in our cardiopulmonary and epilepsy businesses. We're pleased to report record quarterly revenue and earnings per share on a dollar basis while also continuing to expand margins and drive profitable growth. For the cardiopulmonary segment, revenue was $222 million in the quarter, an increase of 10% versus the second quarter of 2025, led by strength in Europe. Heart-lung machine revenue grew in the mid-teens in the quarter, driven by an increase in essence placements in both a sequential and year-over-year basis and sustained favorable price premiums. Cardiopulmonary consumables revenue encompasses all products in our cardiopulmonary portfolio, excluding HLM. Consumables grew in the high single digits in the quarter, driven by low double-digit growth in oxygenators and perfusion tubing kits, partially offset by lower growth in auto-transfusion systems and cannula. Improvements in third-party component availability combined with internal manufacturing optimization have driven meaningful year-over-year increases in oxygenator output, supporting our performance year-to-date. I'd now like to provide an update on our strategy to expand oxygenator output and continue gaining market share. Demand continues to exceed the market's ability to supply. And we believe this creates a significant opportunity to expand our market position. Our operational strategy to capitalize on that opportunity is built on three key components. First, over the past several years, we have gained share by increasing our output through internal manufacturing process improvements. Second, we have invested in expanding our internal manufacturing capacity with a new production line on track to go live in the second half of this year. Third, our strategy is to further increase long-term manufacturing output by partnering with suppliers to address critical component constraints, which have been the primary factor limiting faster market share expansion. Recently, we advanced that strategy by entering into a long-term agreement with Thermo Fisher Scientific, securing access to a critical oxygenator component. Together, our internal capacity expansion and this agreement position us to increase output, capture underserved demand, and consistently supply our customers, all of which contribute to a meaningful competitive advantage. The Thermo Fisher Agreement builds on our existing 2026 expansion plans. We expect its benefits to build over the medium to long term, further strengthening the growth outlook for our oxygenator business. For the full year 2026, we now expect cardiopulmonary revenue to grow nine and a half We continue to expect Essence to represent approximately 80% of annual HLM units placements in 2026, up from 55% in 2025. This forecast assumes continued market share gains in consumables as we execute on our manufacturing expansion plans. Turning to epilepsy. Revenue increased 10% versus the second quarter of 2025. Epilepsy revenue in the Europe and rest of world regions increased a combined 15% versus the prior year period, while U.S. epilepsy revenue increased 8% year over year. Performance was driven by favorable realized price and volume, supported by impactful clinical evidence, improved reimbursement, and sustained commercial excellence. Improved realized pricing in the second quarter was driven by reduced volume discounting in addition to our standard annual list price increase. We are encouraged by CMS's preliminary recommendation to maintain VNS therapy new patient implants in the new tech ambulatory payment classification, as well as the proposed additional increase in the end of service APC reimbursement in 2027. We believe this increase, if implemented, will be a positive development for patients and providers that expands access to care and supports long-term VNS therapy growth. At the same time, the CORE data continue to drive meaningful changes in physician behavior. The growing body of real world evidence is accelerating referrals, strengthening clinicians' confidence, and supporting early adoption of VNS therapy in the treatment pathway. CORE is not only strengthening the clinical value proposition of VNS therapy, but also serving as an important driver of commercial momentum. The combination of improved reimbursement expanding market access Thank you very much. We delivered strong second quarter growth driven by the Essence upgrade cycle and market share gains in oxygenators and cardiopulmonary, as well as improved US reimbursement and compelling clinical data in epilepsy. Looking ahead, we expect these drivers to sustain through 2026 and beyond. As a result, we're now guiding full-year 2026 revenue growth between 8% and 9%, up from 7% to 8% previously. This top-line guidance implies 2026 performance at the high end of the 2025 to 2028 growth framework we outlined at Invest Today. Alex will provide additional details on our 2026 guidance later in the call. With that, I'll hand the call over to Ahmet to cover key innovation updates across the portfolio.

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