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AtriCure, Inc.
11/3/2021
Good afternoon, and welcome to HREcures' third quarter 2021 earnings conference call. My name is Katherine, and I'll be your operator for today's call. At this time, all participants are in a 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 turn the call over to Marisa Beitsch with Gilmore Group for a few introductory comments.
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 HR's control, including risks and uncertainties described from time to time in HR's SEC filings. These statements include, but are not limited to, financial guidance and expectations, expectations regarding the potential market opportunity for HRCARE's franchises and growth initiatives, including Converge and the adoption of the Converge procedure, and future reimbursement. HRCARE's results may differ materially from those projected. HRCARE 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. Our 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. Mike?
Thanks, Marissa. Good afternoon, everyone, and thank you for joining us today. We hope that you're well. Against a difficult backdrop driven by the pandemic headwinds, we delivered solid performance in the third quarter of the year, reaching $70.5 million in total revenue. This represents 29% growth compared to third quarter 2020 and a 1% sequential decline from our strong second quarter 2021 results. We saw year-over-year growth across key product lines in the United States, including contribution from continuing addition of new pain management and hybrid therapy accounts. We were also pleased with the robust performance of our open ablation and appendage management franchises across Europe and Asia. As many of our peers have stated, the third quarter brought continuing challenges driven by the COVID-19 pandemic. We began the third quarter with a record sales month in July. In August and September, however, we began to see some impact from the surges in COVID cases and hospitalizations, along with hospital staffing constraints, which affected the industry broadly. While many healthcare systems have become adept at managing through COVID-related peaks, there are few options to mitigate the shortages of healthcare workers, and we are not immune to these developments. However, the fundamentals of our business, as well as our 2021 financial outlook, remain very much intact. Taking a step back, I would like to highlight our key growth initiatives, beginning with our hybrid AF therapy. In the second quarter, we received PMA approval of the Epicense system as a result of our pivotal Converge clinical trial. This achievement marks the only FDA approval for the standalone treatment of patients with long-standing persistent AFib, which represents approximately 45% of all diagnosed AFib patients. We are pleased with our progress since receiving the PMA. having conducted several didactic physician training programs, executed weekly mobile labs all over the country, initiating many new accounts, and expanding physician use within existing accounts. These early efforts are a very small step on the way to reaching the broad base of accounts and patients, and so much opportunity remains. In addition to the activities noted, we continue to expand our hybrid sales force and add significant dedicated training resources. As a result, even with COVID-related headwinds, we are encouraged by the uplift in MIS ablation revenue in the United States every quarter and the continued progress in appendage management at the same time. As I mentioned, we have only started with our goal of establishing the hybrid convergent procedure as the standard of care for patients with the most complex and difficult-to-treat forms of AFib. It is worth repeating that we believe this is a multi-billion dollar annual opportunity, which should impact many tens of thousands of patients every year. Moving to our open franchise. Following FDA 510K clearance in late July, we recorded our first encompassed device sales in the United States. Initial sales came from a limited launch as we worked toward broader commercial availability later this year. The Encompass Clamp is an innovative addition to our open ablation platform, providing a simpler and faster approach to ablating and open heart procedures. As a reminder, our open ablation platform includes the isolator synergy system, the first medical device to receive FDA approval for the treatment of persistent AFib in late 2011. Even after a decade of market development and training since approval, we estimate that less than one-third of cardiac surgery patients with AFib in the United States are treated today and even fewer globally. We expect the Encompass device, along with our legacy technology, to deepen our penetration of the cardiac surgery market for over the next decade. There is a substantial addressable market for both our open and hybrid ablation platforms with hundreds of thousands of patients annually representing billions of dollars. Complementing the ablation opportunity is our appendage management franchise. As many of you know, we have steadily expanded our Atrial Clip product line through innovation. Coupled with increasing awareness for treatment of the appendage, growth of our Atrial Clip franchise has outpaced our ablation products in recent years. We remain excited by the outlook for continued adoption of appendage management in surgical procedures as a result of the growing body of clinical evidence. Finally, turning to the Cryosphere Probe, our dedicated device for managing postoperative pain in thoracic patients. Our unique technology uses a differentiated freezing method to block nerves from transmitting pain signals after thoracic surgery, providing a long-lasting form of pain relief for patients. CryoNerveLock continues to be one of our fastest-growing therapies, and we are very pleased with our growing account base. In the third quarter, we surpassed $30 million in life-to-date sales of the Cryosphere probe in the United States, just two and a half years after the initial product launch. This represents more than 12,000 patients who have been treated with cryo-neuroblock therapy since early 2019. More recently, we recorded our first cryosphere sale in Europe. While we are proud of our progress, we believe the market for cryo-neuroblock remains vastly under-penetrated, and we continue to increase investments in our dedicated commercial and education teams to drive therapy awareness and adoption. In closing, we continue to execute and are making progress in each franchise around the world. We see robust underlying demand from patients and physicians for the critical treatments that our products enable. We expect to end the year in a strong position for 2022 and beyond, and we remain excited by the potential of our portfolio in the future for Atricare. I will now turn the call over to Angie Wyrick, our Chief Financial Officer, to discuss more detailed results for the quarter.
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