4/29/2025

speaker
Operator
Conference Call Moderator

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 HECURES 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
Gilmartin Group Representative

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 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 statements. 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 CEO.

speaker
Mike Carroll
President and CEO

Great. Good afternoon, everyone, and thank you for joining us. Our first quarter performance reflects the strength of our broad platform of products and continued focus of our team on expanding patient treatment worldwide. For the quarter, we achieved total revenue of $124 million or 14% growth, led by outstanding performance in both our pain management and appendage management franchises. We also drove increasing profitability, reporting $9 million of adjusted EBITDA for the first quarter, which represents an improvement of more than 200% from the first quarter of 2024. In addition to our strong financial performance, we were excited to host our Analyst and Investor Day at our company headquarters in Mason, Ohio on March 26th. At this event, we outlined our vision to remain the leader in each of the multi-billion dollar markets we serve, with investments in product development, clinical research, and therapy development being fundamental to our strategy. Complementing this vision is our goal to deliver double-digit revenue growth and expanding profitability and cash flow through the rest of this decade. While we were thrilled to share our vision and our goals for the business, we were even more excited to bring perspectives of four key opinion leaders in the field of cardiac surgery and electrophysiology. These physicians delivered firsthand insights on our groundbreaking LEAPS trial for the reduction of stroke in non-AFib patients in cardiac surgery using our AtrialClip platform, our upcoming box no AF trial studying prophylactic ablation to reduce post-operative AFib, and the importance of AtriCare's hybrid AF therapy as the only FDA-approved and effective solution for patients with long-standing persistent AFib. Each KOL echoed what we have been saying for years. AFib is a debilitating and devastating disease that remains undertreated. Further, their views and the evidence presented support the use of our ablation and left atrial appendage management products to reduce the risk of AFib and stroke concomitant to cardiac surgery and in standalone treatment of AFib. We also highlighted the science and market behind the vast opportunity of our cryo nerve block therapy for patients undergoing thoracotomy, sternotomy, and now amputations. Pain after surgery slows recovery, increases healthcare costs, and reduces quality of life. We articulated our vision for how crown nerve block therapy can help nearly 1 million patients globally and our strategies to expand even further in the coming years with both new products and approaches. Now I'd like to turn and provide updates on our business and the highlights from the first quarter, beginning with our appendage management franchise. Worldwide appendage management revenue grew 19%, driven by 23% growth in our open atrial clip devices and 7% growth in MIS appendage management devices. We continue to see accelerated growth in our open appendage management business in the United States, where our latest generation of the AtriaClip, the Flex Mini, is quickly being adopted. The AtriaClip Flex Mini device features the smallest profile of any open chest LAA closure device on the market today and continues to garner positive feedback from physicians on the increased visibility and procedures. Following our launch late in the third quarter of 2024, we experienced an acceleration in adoption of AtriaClip Flex Mini this quarter with the number of accounts purchasing more than doubling and contributing over 15% of our U.S. open appendage management revenue. We are focused on further expanding the utilization of AtriaClip Flex Mini as the year progresses and believe this device will be a strong tailwind for growth well into the future. Also during the first quarter, we received 510K clearance for a minimally invasive AtriaClip Pro Mini device. Like the AtriaClip Flex Mini, our Pro Mini device offers significant benefits to surgeons while maintaining the exceptional performance of our AtriaClip platform. The AtriaClip Pro Mini is 60% smaller than the next lowest profile device, enabling enhanced visualization and precise placement, which is particularly important in minimally invasive procedures. Once again, Early physician feedback has been remarkable, and we expect to launch the Atriclip ProMini device in the coming weeks. Next, I'd like to provide an update on our groundbreaking and market-expanding LEAPS trial. We continue to enroll at an extremely fast pace, with even more sites around the world actively engaged in the study this quarter. Earlier today, we reached the total enrollment of 5,500 patients and plan to complete full enrollment of 6,500 patients in the third quarter. As many of you heard from Dr. Whitlock at our Analyst and Investor Day, there's only one chance to manage the appendage in patients with no additional risk, and that is at the time of cardiac surgery. More than half of cardiac surgery patients have risk factors for atrial fibrillation or stroke, and we believe our LEAPS trial will ultimately show the benefit of managing the appendage with an atrial clip device for the millions of patients globally that undergo cardiac surgery every year. Now touching on our AFib ablation franchises. We experienced growth of 14% in our open ablation franchise in the first quarter, including more than 47% growth in sales of the Encompass clamp. Adoption of the Encompass clamp has remained incredibly strong, particularly the short version of the clamp, which further improves ease of use. During the first quarter, we saw approximately 25% growth in the number of accounts from the first quarter of 2024, including new sites in Europe. We remain diligent in our efforts to expand treatment in cardiac surgery, reaching new positions and driving increased use across procedures. As we discussed in detail at the Analyst Investor Day, we are also developing a PFA-enabled version of the Encompass clamp and expect first in human later this year, followed by a clinical trial to study this new device. As a leader in the treatment of AFib in cardiac surgery, we believe it is important to provide the option of PFA for our surgical ablation devices and expect that we will be successful in further reducing procedure time when coupled with our Encompass plan. Our commitment to addressing the global AFib epidemic is now evolving to include the preventative treatment of AFib in cardiac surgery. It is widely understood that cardiac surgery patients experience an elevated risk for developing AFib following their procedure. Postoperative AFib is damaging to the patient, their family, and the healthcare system overall. Our previously announced BOXNO-AF trial will evaluate the benefits of treating patients without preoperative AFib with our Encompass clamp and the Atrial Flip devices. The study has been approved by the FDA, and we will begin initiating clinical trial sites and enrolling our first patients later this year. We expect that completing the box no AF trial will greatly expand our market for the devices worldwide and pioneer a new standard in cardiac surgery. Turning to minimally invasive AFib treatment, which includes the hybrid AFib therapy. While the excitement around PFA is understandable and is the pressure on our near-term growth, it remains clear that patients with long-standing persistent AFib require a more robust procedure to address their disease. As shown in the three-year follow-up of CONVERGE and CEASE-AF randomized trials, these differences get stronger and more pronounced as time progresses, demonstrating hybrid AF therapy to be incredibly durable over time. Hybrid AF therapy procedure revenue experienced another outstanding quarter in Europe, with nearly 50% growth, while we face downward pressure in the United States. We expect this pressure to continue in the near term in the U.S., but remain steadfast in our belief that With time, EPs will begin to identify segments of the population of patients for hybrid AF therapy, leading to long-term adoption and success of this procedure in treating patients with advanced AFib. And finally, our pain management franchise saw an acceleration in growth to 39% in the first quarter. Pain management performance reflects the rapid adoption of our latest CryoServe Max and CryoServe Plus probes, where we are experiencing broader use within existing accounts as well as interest from new accounts. To that end, total accounts were 12% in the first quarter, showing our continued development of cryo-neuroblock therapy worldwide. While we deepen our penetration in thoracic surgery procedures, we are also excited to expand our addressable market with the recent FDA 510K clearance of our Cryo-XT probe, designed specifically for extremity amputations, more than 180,000 of which take place annually in the United States. We expect to launch our Cryo-XT probe later this year. Based on our research and experience to date, the Cryo-XT probe will offer a new solution for preventing or treating phantom and residual limb pain in an easy-to-use and opioid-free device. Traditional opioid-based therapies present a litany of issues related to misuse, addiction, and elevated healthcare costs. Through our organic development efforts and pain management, our goal is to reach every patient suffering from post-operative pain and reduce the dependency on pharmacological solutions for managing that pain. Our pain management franchise remains an exciting and truly innovative component of our business, and we expect continued strength throughout 2025 and well beyond. So in closing, our results reflect another robust quarter of progress throughout our business. from strong worldwide growth to exceptional activity in new product launches and clearances, the continued advancement of research and development programs, and execution of our plans to improve profitability. I am truly proud of the efforts of the entire HR team in delivering an outstanding start to the year and remain confident in our shared vision to establish our products and therapies as the standard of care in each of our markets. And with that, I'll turn the call over to Angie Wyrick, our Chief Financial Officer. Angie?

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