2/17/2026

speaker
Operator
Conference Call Operator

Good afternoon, and welcome to AtriCure's fourth quarter and full year 2025 earnings conference call. This call is being recorded for replay purposes, and at this time, all participants are in listen-only mode. We will be facilitating a question and answer session following prepared remarks from AtriCure's management. I would now like to turn the call over to Marissa Beitsch from the Gilmartin Group for a few introductory comments.

speaker
Marissa Beitsch
Investor Relations, Gilmartin Group

Great, thank you. By now, you should have received a copy of the earnings press release. If you have not received a copy, please call 513-644-4484 to have one emailed to you. Before we begin today, let me remind you that the company's remarks include forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond HRCARE's control, including risks and uncertainties described from time to time in HRCARE's SEC filings. These statements include, but are not limited to, financial expectations and guidance, expectations regarding the potential market opportunity for Atricure's franchises and growth initiatives, future product approvals and clearances, competition, reimbursement, and clinical trial outcomes. Atricure's results may differ materially from those projected. Atricure undertakes no obligation to publicly update any forward-looking statements. Additionally, we refer to non-GAAP financial measures, specifically constant currency revenue, adjusted EBITDA, adjusted EBITDA margin, and adjusted loss per share. A reconciliation of these non-GAAP financial measures with the most directly comparable GAAP measures is included in our press release, which is available on our website. And with that, I would like to turn the call over to Mike Carroll, President and CEO.

speaker
Mike Carroll
President and CEO

Thank you, and good afternoon, everyone. And thank you for joining us. 2025 was an exceptional year at Agicure with achievements across our business. We closed the year with total revenue of $534 million, reflecting 15% growth over 2024 and made substantial improvements to profitability and cash generation with nearly $62 million in adjusted EBITDA and $45 million in cash generated in 2025. More importantly, 2025 demonstrated the power of our innovation engine We accelerated worldwide revenue growth in three of our four franchises, driven by newer product launches, such as our CryoSER Max Probe and AtriaClip Flex Mini device, continued adoption of our therapies, notably with the Encompass Clamp, and launched two new products during the year, our AtriaClip Pro Mini and Cryo XT Probe. As a result of our strong operational execution and meaningful progress across these strategic priorities, We are well positioned for the year ahead and reaffirm our guidance for 2026 revenue growth of 12% to 14% growth. It is now almost one year since we hosted our March 2025 Analyst and Investor Day, where we featured several catalysts for our business and established long-term financial targets. We committed to sustained double-digit revenue growth, expanding profitability, and meaningful cash generation. and we have delivered on all three. Simply put, we are outpacing the plan. We generate a revenue growth of 15% for the year, and the operating leverage in our business is becoming increasingly visible. R&D spend is leveling off with the completion of the enrollment in leaps. Our commercial team is driving efficiency gains in SG&A, and our new product launches are contributing to gross margin improvement. In addition to our financial progress, we have advanced key strategic initiatives outlined at our investor day. First, our groundbreaking LEAPS clinical trial completed enrollment of more than 6,500 patients last July, well ahead of expectations. This trial is evaluating the benefit of our atrial clip devices on non-APHIP patients undergoing cardiac surgery, representing a global opportunity of nearly 1.4 million patients each year. Interest and participation from our trial investigators was outstanding, with more than 500 surgeons across 137 different sites who enrolled in the LEAPS trial. During the years ahead, we will continue to follow LEAPS patients as we await the results of the trial. Following LEAPS enrollment, we initiated our Box-X NOAAF clinical trial, a 960 patient randomized controlled trial aimed at reducing the onset of postoperative AFib in cardiac surgery patients who do not have preexisting AFib. Up to 50% of cardiac surgery patients without AFib will develop postoperative AFib, making it the most common complication in cardiac surgery. The stark reality is that these patients tend to see worse acute and long-term clinical outcomes. Postoperative AFib is also associated with a higher healthcare cost burden, with estimates exceeding $2 billion annually in the United States alone. Using our encompass clamp and atrial clip devices, we believe this trial will demonstrate the benefits of ablation for non-AFib patients during cardiac surgery. We are pleased with our progress on the site initiation and enrollment today and look forward to updating you throughout the year. In addition to these landmark clinical trials, we are also advancing development efforts on our dual energy encompass clamp. Our goals for this program center around shortening RF ablation times and introducing PFA as a complimentary energy source. On its own, our innovative encompass clamp technology was a significant step in streamlining cardiac surgery ablation procedures, leading to increasing adoption. Now, by pairing advanced RFA With PFA in our Encompass device, we will deliver unprecedented speed and flexibility for surgeons. During 2025, we reached two milestones with our development partner and completed first in human treatments in December with excellent results. In the year ahead, we expect to finish device and generator development in preparation of the initiation of a clinical trial, marking another key milestone in our product development pipeline. At our investor day, we shared our strategy for building upon the greenfield opportunity in surgical pain management, including expansion into amputation procedures. We launched our CryoXD device for pain management and amputation procedures in the third quarter of 2025 and continue to receive overwhelmingly positive surgeon feedback. Patients are recovering faster than ever, experiencing less acute post-operative pain, and in many cases, with reduced phantom limb pain as well. We are being deliberate in our rollout, with each cryo-neuroblock route focusing on one account at a time to ensure adoption is sticky before expanding our user base. As we cultivate this opportunity, we expect cryo-XD to contribute more meaningfully to revenue in the back half of 2026. Taking a step back, each strategic initiative coupled with continuous product innovation that is the hallmark of AtriCure, supports our vision to create standards of care across all of our markets. BoxX, NOAAF, and Leafs also share an objective that is truly transformational for our company, moving standards of care in cardiac surgery towards preventative treatment of AFib and related complications. Both trials enable AtriCure, and AtriCure alone to unlock massive market expansion opportunities and future growth acceleration. Now on operational highlights from each of our franchises from the fourth quarter and full year 2025. Starting with pain management, in the fourth quarter of 2025, we achieved 24% growth, driven by continued increasing adoption of our CrossFair Max device. The time savings offered by this device compared to our legacy probe have been compelling to surgeons, particularly those in thoracic surgery. For the year, worldwide revenue grew 33% in 2025, marking an acceleration from 2024 growth. We ended the year with roughly 500 accounts in the U.S. choosing our Cryosphere MAX device and saw growth in accounts utilizing crown nerve block worldwide. In addition, during 2025, we reached over 100,000 patients treated with our Cryosphere probes, framing the tremendous growth and patient impact of this franchise since launching in 2019. Turning now to appendage management, we delivered fourth quarter growth of 15% globally with open left atrial appendage growth well outpacing our MIS left atrial appendage devices. We are pleased with the consistent momentum of our open appendage management business, which powered full year worldwide revenue growth for our left atrial appendage franchise of 19%, again, marking an acceleration over 2024. AtriClip Flex Mini and AtriClip Pro Mini largely drove this acceleration and growth, with surgeons drawn to the low profile of our mini AtriClip devices. Much of our growth is volume driven, though we also benefit from a favorable price mix as surgeons convert from legacy devices. We exited 2025 with over 300 active accounts purchasing Flex Mini, and saw FlexMini contribute 18% of our worldwide left atrial appendage management revenue in 2025, leading to increased market share in the United States. We believe our innovation, along with our robust clinical evidence and superior product performance, has and will continue to differentiate our atrial clip devices from the competition. Within our AFib ablation franchises, open ablation growth came in over 17% for both fourth quarter and full year 2025, with the Encompass clamp being the primary contributor. The durability of Encompass growth since launch in 2022 exemplifies the staying power of Atricare innovation. As I mentioned earlier, Encompass dramatically reduced procedure times and simplified open heart ablation, enabling a deeper penetration in treating AFib concomitant to cardiac surgery. Our Encompass clamp is now present in over 830 accounts worldwide, reflecting a mid-teens increase over 2024. In the U.S., our Encompass utilization is further along. We are seeing adoption largely improve in penetration of CABG procedures. That said, the treatment of pre-op AFib patients undergoing cardiac surgery remains vastly underpenetrated. At the most recent Society of Thoracic Surgeons STS conference last month, we were excited to learn that concomitant AFib treatment is no longer optional. It will be a quality metric in which hospitals will be evaluated and graded by their adoption of this metric. By early next year, it will be included in star ratings, which patients and physicians use to determine who provides the best care. This is only the second time in the past 25 years, where a therapeutic treatment has become a quality metric in cardiac surgery, and we want to recognize the contributions of our physician partners to this effort. They have put a stake in the ground related to the treatment of AFib, which will benefit tens of thousands of patients moving forward. This change builds upon existing societal guidelines that recommend treatment, and AtriaCare's specific technology, which makes it feasible to treat placing a spotlight on the opportunity for continued growth in open-heart procedures. And finally, in minimally invasive AFib treatment, our hybrid AFib therapy continued to feel the pressure of PFA adoption in the U.S. in 2025. This was a tough headwind for our business. With full-year worldwide revenues declining 26% for 2024, we believe there's a compelling clinical value for hybrid AF therapy in patients with long-standing persistent AFib. However, it is undeniable that PFA catheters are dominating the standalone AFib treatment right now. As we exited the year, we saw an encouraging sign with sequential revenue improvement in the US from the third quarter to the fourth quarter in added accounts performing the conversion procedure. While these signals are positive, we are looking for evidence for further stabilization of a hybrid franchise, which reflects broad-based and repeatable trends across our customers. We remain prudent in our outlook and are assuming continued pressure in our U.S. hybrid business in 2026, although we are anticipating a lower rate of decline than in 2025. We remain committed to this market and the millions of patients with advanced AFib who can benefit from our approach. and our team and infrastructure remain ready to scale as the market recognizes the value of hybrid AF therapy. In closing, 2025 was a year of substantial growth and remarkable execution for AtroGear. Our progress is a testament to the dedication of our talent, of the extended team who remain committed to advancing our mission and our goals. We are delivering better than promised growth, financial and strategic initiatives, and are excited for our momentum to continue in 2026. And we will work to transform standards of care in each one of our markets for many years to come. And with that, I will turn the call over to Angie Wyrick, our Chief Financial Officer. Angie?

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