10/29/2025

speaker
Operator
Conference Operator

Good afternoon, and welcome to HRECURE's third quarter 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 HRECURE's management. I would now like to turn the call over to Marissa Beisch from the Gilmartin Group for a few introductory comments.

speaker
Marissa Beisch
Investor Relations, The Gilmartin Group

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 HR's control, including risks and uncertainties described from time to time and HRCURES SEC filings. These statements include, but are not limited to, financial expectations and guidance, expectations regarding the potential market opportunity for HRCURES franchises and growth initiatives, future product approvals and clearances, competition, reimbursement, and clinical trial outcomes. HRCURES results may differ materially from those projected. Atricure undertakes no obligation to publicly update any forward-looking statement. Additionally, we refer to non-GAAP financial measures, specifically constant currency revenue, adjusted EBITDA, 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. With that, I would like to turn the call over to Mike Carroll, President and Chief Executive Officer.

speaker
Mike Carroll
President & Chief Executive Officer

Great. And good afternoon, everyone. Thank you for joining us today. We had a very strong third quarter with total revenue of $134 million, reflecting a 16% increase year over year. Our growth was driven across key franchises globally, demonstrating the expanding adoption of our therapies and breadth of market opportunities. We also substantially improved profitability and cash generation with nearly $18 million of adjusted EBITDA and over $30 million in cash generated in the third quarter. Overall, our revenue growth and profitability exceeded expectations for the quarter, and we will once again raise guidance for the year. Product innovation and clinical science initiatives continue to flourish at AtriCare, and that is evident in the success of our recent product launches. The AtriaClip Flex Mini and Cryosphere Max devices are propelling outstanding growth in appendage and pain management in the United States. The launch of our Encompass clamp is driving accelerated growth in Europe while continuing to fuel steady growth in the United States many years after launch. And we are building on surge in interest in this product with our PFA platform development program, and further expanding our market opportunity with the initiation of our BoxX NOAAF clinical trial. Additionally, our Cryo XT device launched this quarter will set a new standard for managing pain in lower limb amputation procedures. Each initiative reflects our commitment to delivering innovative therapies to address unmet clinical needs for patients around the world. Now on to updates from each of our franchises. Starting with appendage management, where worldwide revenue grew over 20%, continuing the acceleration realized in the first half of 2025. This is a direct result of increasing adoption of our AtriaClip Flex Mini and Pro Mini devices. Both devices leverage our third-generation AtriaClip platform technology, featuring a smaller profile clip, which improves visibility in procedures. These devices are the smallest surgical LA implants available and build on more than a decade of outstanding results for the over 700,000 patients treated on our AtroClip platform. Related to the AtroClip, early in the third quarter, we completed enrollment of over 6,500 patients across 137 sites globally in our landmark clinical trial lease. The success of enrollment is a reflection of the strong interest from trial investigators, of which over 500 surgeons participated and are now focused on patient follow-up. As most of you know, the LEAPS trial is designed to evaluate the use of age-equipped devices for stroke prevention in cardiac surgery patients who do not have prior AFib diagnosis. This is a significant underserved patient population. with more than 70% of the nearly 2 million patients who undergo cardiac surgery annually not having a prior AFib diagnosis. And we are very excited about the potential ahead. While we await the results of the trial, we are driving physician awareness and expanding access to AtriaClip devices globally. To that end, we are pleased to announce the recent approvals of our AtriaClip FlexV, ProV, and FlexMini devices in Japan. In addition to the groundbreaking clinical evidence from LEAPS, we intend to stay leaders in this market with continuous innovation and have turned our research and development efforts towards delivering the next generation of atrial clip devices. And we look forward to sharing our progress over the coming year. Within our ablation franchises, open ablation growth accelerated to over 18% for the quarter. Sales of our Encompass clamps continue to drive growth in the United States, and the launch in Europe boosted our international results. As I commented last quarter, the durability of the Encompass clamps' growth is a clear testament to our ability to deliver meaningful and consistent innovation, providing clinicians with effective and time-saving solutions. We expect to further advance concomitant ablation procedures. with our platform development of an encompass clamp enabled with PSA. We are making progress with robust preclinical testing and expect first-in-human use over the coming months. Non-technical innovation, we're also moving forward with our Box-X no AF clinical trial and are excited to share that the first patient was treated. The Box-X no AF trial is another foundational study at Atricare aimed at reducing the onset of post operative AFib in cardiac surgery patients who do not have a pre-existing AFib condition. This trial will significantly expand the opportunity to use our ablation technologies in this broader patient population, multiplying our cardiac surgery market opportunity overall. Adding to the momentum from our LEAPS trial, we believe Box-X, no AF, will transform the standard of care in cardiac surgery towards preventative approaches. And on our minimally invasive hybrid therapy, market dynamics remain challenging in the U.S. due to increased adoption of PFA catheter technology. Nonetheless, we continue to see substantial unmet need for patients with longstanding persistent AFib and believe that our hybrid AF therapy is uniquely positioned to address this need. Finally, turning to our pain management franchise, which grew 28% in the quarter and was driven by sales of our latest product innovations, the Cryosphere Max and Cryosphere Plus Pros. These product launches have shown the value of reducing procedure times, allowing us to increase market penetration in thoracic surgery and gain traction in the sternotomy market. Another reason for optimism in our pain management business is the launch of Cryo XT, which improves recovery and quality of life in patients following extremity amputation. Feedback already from surgeons using the Cryo-XT device has been encouraging, and we are even more excited by the reports of rapid patient recovery in the days following the procedure. As is the case with new therapy development, it will take time to ramp the Cryo-XT use, but we are confident that the benefits for patients, physicians, and hospital economics are significant. We recently launched the Vanish Registry to track patient outcomes with Cryo XT and expect this data to demonstrate acute and phantom limb pain reduction with our cryo nerve block therapy in patients undergoing extremity amputation. Cryo XT unlocks a meaningful expansion opportunity in pain management and is another example of our ongoing commitment to innovation across all of our franchises. Going forward, We will also continue to invest in comprehensive clinical and economic data to support the value of cryonerve block therapies. A non-opioid pain management, but as non-opioid pain management becomes an increasing priority across healthcare, these efforts are helping drive broader awareness and adoption. In closing, I want to express my gratitude to our entire HFEAR team for another successful quarter. Your work demonstrates an unrelenting focus on patients. We are executing well on our growth and profitability objectives, including record cash generation, this quarter providing a strong foundation as we end the year and go into 2026. I am confident that our shared determination to deliver exceptional patient outcomes and executing on our strategic priorities will transform standards of care in each of our markets. And with that, I'll turn the call over to Angie Weirich, our Chief Financial Officer. Angie?

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