7/29/2025

speaker
Operator
Conference Operator

participants are in listen-only mode. We will be facilitating a question-and-answer session following the prepared remarks by HHR's management. I would now like to turn the call over to Marisa Beisch from the Gilmartin Group for a few introductory comments.

speaker
Marisa Beisch
Moderator, 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 513-644-7000. 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 HRCUR's control, including risks and uncertainties described from time to time in HRCUR'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 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 and Chief Executive Officer

Good afternoon, and thank you for joining us. We are pleased to report an outstanding second quarter with total revenue of $136 million, reflecting a 17% year-over-year increase. Our growth was broad-based, reinforcing the strength and durability of our business and H-Recure's significant market opportunity across all of our franchises. We also delivered a sizable increase in profitability and cash generation, with over $15 million in adjusted EBITDA and nearly $18 million in cash generation in the second quarter. Our pipeline of innovation and clinical science initiatives continues to thrive and generate results as well. More specifically, new product launches, such as AtriaClip Flex Mini and CryoSphere Max, drove accelerated growth in pain management and appendage management, and the first lower limb amputation procedures using our CryoXT device for pain management were performed in this quarter. Additionally, we began testing our PFA device for cardiac surgery. However, Most notable is the completion of enrollment in our groundbreaking LEAPS clinical trial. I will touch upon these milestones in greater detail later in my remarks, but each reflects our resolve to deliver innovative therapies to address unmet clinical needs for patients around the world as we sustain strong growth and improve shareholder returns. Now on to updates from each of our franchises. Starting with Appendage Management, worldwide revenue grew over 20%, driven by open left atrial appendage management growth of 29%. In the United States, we saw an acceleration in revenue from increasing adoption of our AtriaCoop Flex Mini device. This quarter, Flex Mini reached just over 20% of our U.S. appendage management revenue, showing the demand from physicians for this lower-profile solution. Internationally, we are expanding access to AtriaCoop devices and continuing to invest in physician awareness to support long-term growth. We also are excited to announce the first clinical use of our latest innovation in the Atroclip platform, the Atroclip Pro Mini device. Building on the success of the Flex Mini in open chest procedures, the Pro Mini leverages our third generation Atroclip platform, which is the smallest surgical left atrial appendage implant available, enhancing visualization and precision during minimally invasive procedures. The ProMini is another example of our ongoing commitment to innovation across our franchises. Turning to our LEAPS trial, we are thrilled to announce we completed enrollment earlier this month. This is a major milestone, not only for AtroCure, but for all cardiac surgery and patients treated, as it marks the largest global medical device clinical trial ever conducted in this space. with total enrollment exceeding 6,500 patients. LEAPS is designed to evaluate the use of atrial clip devices for stroke prevention in cardiac surgery for patients who do not have a prior AFib diagnosis. This is a large and underserved patient population with more than 70% of the nearly 2 million patients who undergo cardiac surgery annually not having a prior AFib diagnosis. We believe The rapid pace of enrollment reflects the strong momentum behind our clinical evidence strategy and interest from surgeons and the broader clinical community in expanding the standard of care for these patients. I would like to pause and recognize the team at Atracare for truly outstanding trial execution and our physician and hospital partners who are instrumental in this landmark study. Your collective efforts achieved full enrollment well ahead of our initial projections and place us closer to definitive clinical evidence supporting left atrial appendage management in cardiac surgery. Now we shift our focus to robust patient follow-up as we await the study outcomes. We expect results from our LEAPS clinical trial to support a stroke prevention indication that is exclusive to Atroclip surgical devices and help shape future treatment guidelines. Within our ablation franchises, Open Ablation posted a healthy growth of 15% this quarter. Performance was once again led by our Encompass Clamp, reflecting deep, continued adoption across a broad customer base. This quarter also marked the third anniversary of the Encompass Clamp launch. The durability of Encompass growth is a clear testament to our ability to deliver meaningful and consistent innovation, providing clinicians with effective and time-saving solutions. On the topic of innovation, we are also progressing development of our PFA-enabled Encompass platform. During the quarter, we achieved the first milestone in our PFA partnership with the delivery of generators to begin robust preclinical testing, putting us one step closer to first in human use, which we expect to happen later this year. We look forward to providing more updates on our development milestones as they occur. Turning to clinical initiatives, we are preparing sites activation in our box no AF trial. As discussed at our investor day earlier this year, box no AF is aimed at reducing post-operative AFib in cardiac surgery patients who do not have pre-existing AFib, increasing our addressable market by over threefold by significantly expanding the opportunity to use our ablation technologies in this broader patient population. Building on momentums from our LEAPS trial, We believe BOCS-NOAF will transform the standard of care in cardiac surgery toward preventative approaches for patients without AFib. BOCS-NOAF is a foundational study for AtriCare, and we expect the first patient to be enrolled in the trial later this year. In our minimally invasive hybrid therapy, market dynamics remain challenging in the U.S. due to increased adoption of the PFA catheter technology. We continue to see durable interest and our MIS offerings in Europe, where PFA has been on the market longer and clinical understanding and patient segmentation are more advanced. We believe patients with longstanding persistent AFib remain undertreated, and our hybrid therapy is uniquely positioned to address this need. Now turning to our pain management franchise, which grew nearly 43% in the quarter. The acceleration and growth continues to be driven by sales of our latest innovations, the Cryosphere Max and Cryosphere Plus probes. We are realizing significant expansion within existing accounts along with new physician users, and we are also encouraged by feedback from surgeons using Cryosphere Max and sternotomy procedures where reduced procedure time is particularly impactful. Additionally, we are expanding access to our next generation cryoablation technology outside the U.S. with the launch of Cryosphere Max in Europe. This launch represents another step in bringing superior pain management solutions to patients and providers globally. In addition to growth in thoracic and cardiac procedures, we're encouraged by the opportunity for crown nerve block therapy and extremity amputations. Following 510K clearance early in the second quarter, we completed initial procedures with our CryoXD probe for pain management and lower limb amputations. While feedback from surgeons using this device has been excellent, we are even more excited by the reports of rapid patient recovery in the days following the procedure. We believe Cryo XT unlocks a meaningful expansion opportunity for AtriCure, and we're focused on preparing for commercial launch later this year. Parallel to our innovation and market expansion efforts, we continue to invest in clinical and economic data to support the value of cryonerve block therapies. As non-opioid pain management becomes an increasing priority across healthcare, these efforts are helping drive broader awareness and adoption. We remain committed to expanding access to innovative non-opioid solutions that improve patient outcomes and align with the goals of hospitals, surgeons, and payers. In closing, I want to thank our entire team for an outstanding quarter. Our financial results were stellar, with accelerating growth and meaningful improvement to profitability, providing a strong foundation for the second half of 2025 and beyond. I am confident that our focus on delivering exceptional patient outcomes, building our clinical and commercial momentum, and executing on our strategic priorities will transform standards of care in each of our markets. And with that, I will turn it over to Angie Wyrick, our Chief Financial Officer. Angie?

Disclaimer

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