2/15/2022

speaker
Conference Call Operator
Moderator

Good afternoon and welcome to EntryCare's fourth quarter 2021 earnings conference call. At this time, all participants are in listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to hand 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 513-755-4136 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 HRCURES control, including risks and uncertainties described from time to time in HRCURES FCC filings. These statements include but are not limited to financial expectations and guidance, expectations regarding the potential market opportunity for HRECURE's franchises, and growth initiatives, including the adoption of the hybrid AF procedure and future product approvals, clearances, and reimbursements. HRECURE's results may differ materially from those projected. HRECURE undertakes no obligation to publicly update any forward-looking statements. Additionally, we refer to non-GAAP financial measures specifically revenue reported on a constant currency basis, adjusted EBITDA, and adjusted loss per share. A reconciliation of these non-GAAP 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. Mike?

speaker
Mike Carroll
President and Chief Executive Officer

Thanks, Marisha. Good afternoon, everyone, and thank you for joining us. We hope that you're all well. The fourth quarter of 2021 concluded an extraordinary year for AtriCare. As described in a preliminary announcement in this afternoon's release, we delivered $73.2 million in revenue in the quarter, reflecting growth of approximately 27% over the fourth quarter of 2020 and 4% sequentially. Growth was primarily driven by pain management and hybrid AF therapy franchise expansion in both existing and new accounts, while underlying strength in our appendage management franchise continued to reflect the broad appeal of our Atriclip product line. Before providing a more detailed review of the business, I want to recognize the ongoing challenges related to the continued impact of the COVID-19 pandemic. At the beginning of the fourth quarter, many of our customers experienced staffing shortages and capacity constraints, suppressing cardiac procedure volumes. The quarter ended much like 2020, with a spike in cases that brought difficult operating conditions across our customer base. These constraints have carried over and continue to impact 2022. Like many other companies, we are still experiencing pressure from the pandemic this quarter, although we are pleased to have seen an uptick in volumes in recent weeks as conditions slowly begin to improve. We continue to believe our business is positioned for strong growth over the year ahead, and we are reaffirming our annual guidance of $315 million to $330 million in 2022. I would like to highlight the initiatives facilitating our growth, starting with our hybrid AF therapy for longstanding persistent AFib patients. We are pleased with our progress since receiving PMA approval from our pivotal Converge clinical trial in April 2021. As a reminder, this achievement marks the only FDA approval for the standalone treatment of patients with longstanding persistent AFib. We estimate that approximately 45 percent of the millions of diagnosed AFib patients are longstanding persistent, presenting Atricure with a unique opportunity to establish the hybrid AF procedure as the standard of care in this vastly under-penetrated market. As last year unfolded, we saw procedure volumes rebound to near pre-COVID levels and then begin to accelerate in the second half of the year. We ended the year with record Epicent system sales in the fourth quarter. So much potential remains to add new accounts and grow our physician base within existing accounts within this multi-billion dollar market opportunity. We are increasing training efforts to meet the demand from the physician community and recently added a third mobile lab. We also continue to expand our commercial team to the addition of sales reps and clinical support, as well as therapy awareness reps to build relationships and develop programs focused on the needs of the cardiology community at large, as we look further upstream within patient referral channels. Turning now to our open ablation franchise, where we marked the 10th anniversary of our PMA approval for the isolator synergy ablation system. This foundational technology of AtroCure was the first medical device approved for the treatment of persistent and longstanding persistent AFib during open heart procedures. We have spent the past decade driving physician awareness education, and adoption, resulting in consistent growth and expansion of the therapy since 2011. More recently, we received FDA 510K clearance for our Encompass device, which provides a simpler and faster approach to ablating open-heart procedures. Through the limited launch, we have now completed over 150 procedures in the United States. The success to date of our limited launch gives us conviction in the Encompass Clamp's broad appeal to high-volume cardiac surgeons. We are moving towards full commercial availability in 2022 and expect this device, along with our legacy technology and focused commercial and market development resources, to deepen our penetration of the cardiac surgery market over the next decade. Complementing our opportunities in both open and hybrid ablation is our appendage management franchise. In 2021, the Atrica product line grew 39%. with record sales of Atroclip Flex V devices. We are working on continued innovations to enhance this business in the future. We expect to see steady expansion of the franchise as the mounting wave of clinical evidence grows for our appendage management in the surgical procedures and from the expansion of the hybrid AF therapy. Finally, turning to our pain management franchise, CryonurBlock. We entered the pain management market nearly six years ago with the goal of improving the recovery of patients undergoing cardiothoracic surgery. The early results were compelling, leading to the development and 2019 launch of our Cryosphere Probe, a dedicated device for managing postoperative pain in thoracic surgery patients. Our unique technology uses a differentiated freezing method to block the nerve from transmitting pain signals after thoracic surgery, providing a long-lasting form of pain relief for patients. CrowdNerveBlock has become one of our fastest-growing therapies, providing an uplift of our open ablation results. In 2021, we nearly doubled our crowd nerve block commercial team, doubled our U.S. market penetration, and expanded to more than 400 accounts and received CE mark approval in Europe. We will continue to invest in our dedicated commercial and education teams to drive therapy adoption this year. Beyond our core driver, drivers a number of clinical innovation and regulatory developments position us for ongoing expansion. In appendage management, we expect submission of our LEAPS protocol to the FDA this year and subsequent initiation of the clinical trial to study the prophylactic use of the atrial clip device after promising results from the ATLAS trial. More than two-thirds of cardiac surgery patients do not have preoperative AFib diagnosis, representing a significant expansion of the addressable market for appendage management globally. While the LEAPS trial will take a number of years to complete, we expect awareness for treating the appendage to continue to increase. Next, we are looking to expand into markets that are highly complementary to our core competency of treating complex arrhythmias, leveraging the unique physician relationships we have developed and building upon HECARE RF ablation technology. We expect to begin a new IDE trial for the treatment of patients with inappropriate sinus tachycardia, or IST, using hybrid ablation procedures. This disease results in an extremely elevated heart rate and distressing symptoms of heart palpitations contributing to the inability to sleep or exercise. Like AFib, IST has a dramatic impact to a patient's quality of life. IST most often occurs in young women, and currently there are no approved treatments. The trial, which we are calling HEAL-IST, along with the development of a dedicated device, focuses on the solution for the significant unmet need. We also continue to expand investigator-sponsored research programs with particular emphasis on real-world evidence for our therapies through registries. In addition to our clinical activities, we have ongoing reimbursement efforts for our cryo-neuroblock and other therapies. Internationally, we received clearance of our first product in Europe under the new EU Medical Device Regulations, or MDR, and we have a strong foundation of expertise to build on and expect to continue to pursue additional product clearances throughout our international markets. In summary, we remain excited about our potential in 2022 and over the next decade. Our growth opportunities are diverse, and our products offer differentiated and proven solutions in markets with substantial unmet needs. While new challenges arose over the past two years for companies across the industry, we remain very bullish on the future of AtriCare. Before I turn the call over to Angie, I want to highlight another important initiative, our inaugural ESG report, which we published last week. Our commitment to operating responsibly, sustainably, and improving the well-being of the communities around us has long been an important aspect of our culture and one that we take seriously. Our ESG strategy is tied directly to our core values to heal the lives of patients, grow and empower our people, and collaborate with our partners. In this report, we address our ESG achievements so far and lay out additional initiatives we are undertaking. I encourage you to read the report to learn about our efforts, and we'd be happy to discuss our work in this area in more detail. I'll now turn the call over to Angie Wyrick, our Chief Financial Officer, to discuss more detailed results for the quarter.

Disclaimer

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