AtriCure, Inc.

Good afternoon and welcome to HREQ's second quarter 2021 earnings conference 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 the calls today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Lynn Lewis from the GoMartin 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 HRCARE's control, including risks and uncertainties described from time to time in HRCARE's SEC filings. These statements include but are not limited to financial guidance, expectations regarding the timing of FDA reviews and expectations for product approvals, expectations regarding the potential market opportunity for Converge, and the adoption of the Converge procedure. Adricure's results may differ materially from those projected. Adricure undertakes no obligation to publicly update any forward-looking statement. 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 financial measures with the most directly comparable GAAP measures is included in our press release, which is available on our website. With that, I'd like to turn the call over to Mike Carroll, President and Chief Executive Officer. Mike?

Thanks, Lynn. Good afternoon, everyone, and thank you for joining us. We hope that you're doing well. As you saw in this afternoon's press release, we are continuing the strong momentum from the first quarter with over $71 million in total revenue for the second quarter of this year. This represents 75% growth compared to the second quarter of 2020 and 20% sequential growth over the first quarter of 2021. Our strong top line performance was driven primarily by the recovery of procedure volumes in major markets with some small portion due to patient backlog. More encouragingly, against a backdrop of stabilizing patient flow, we experienced robust growth in each of our franchises with many new sites and increasing penetration in existing facilities. The desire among patients and physicians to have access to these critical treatments continues to rise. To that end, we saw accelerating growth throughout the quarter across all platforms in the U.S., complemented by a solid rebounding of activity in Europe and Asia. As we begin the third quarter, energy remains positive across our business, and July started strong. While we have started to see some slowdown in procedures in areas where COVID is surging, we continue to expect a strong back half of the year. Now we will start with an update on the AMAZE clinical trial. As a reminder, we finished enrollment in the trial shortly after the August 19th acquisition of CentiHeart, then began the PMA modular submissions in late 2020, and completed final patient follow-up this past April. More recently, we were unblinded to the AMAZE clinical trial data. While we are not sharing details of the results today, in summary, despite achieving the primary safety goal, the primary efficacy endpoint of the AMAZE trial was not met. We are still learning more as we evaluate the trial data and engage in discussions with our medical advisory board and the FDA. However, the pathway for PMA submission is uncertain at this time. Although we hope for a different outcome from the MACE trial, we are encouraged by the safety results and believe there is an underpinning of value from the investment in CenterHeart that we will continue to leverage going forward. This includes an experienced team with unique technical and clinical knowledge in the EP space, relationships we have since built within the EP lab setting and community, and a robust portfolio of IP that complements our core technologies. As we move forward, our conviction for innovation supported by clinical science across all of our businesses remains unchanged. Therefore, we will continue building a differentiated portfolio of products, expanding treatment options for the vast and growing population of AFib patients. Let's turn now to the many advancements in our key growth initiatives. The second quarter was transformative for HECARE with PMA approval of the Epicense system for treatment of patients with long-standing persistent AFib. This approval resulted from the groundbreaking CONVERGE trial, which demonstrated superiority of the hybrid AF therapy using the Epicense device to endocardial catheter ablation alone. Patients with long-standing persistent AFib, the most advanced and difficult-to-treat form of the disease, represent nearly half of the more than 33 million patients affected by AFib worldwide. The Epicent system is the first and only to receive FDA approval for standalone treatment of these patients, providing critical and sustainable differentiation in the market. Our opportunity is clear, and this achievement marks a pivotal moment in our company. The approval provides us the ability to help educate and train physicians on the benefits of hybrid AF therapy with the Epicent system to improve the lives of millions of underserved patients. Our U.S. sales team is now executing on our commercial launch, engaging both new and existing sites and driving awareness within the EP and cardiology communities. In late June, we hosted our first hybrid AF training therapy event where expert faculty guided peer-to-peer discussions and addressed clinical questions. leading to a rich dialogue on hybrid AF therapy and emphasizing the patient benefit that results from close collaboration between the specialties. This inaugural training event was just one of many activities throughout the quarter following FDA approval in late April. Our goal is for the hybrid AF therapy utilizing the Epicense device to become the standard of care for the millions of patients with longstanding persistent AFib. Moving to our open franchise, we are pleased to announce that we've got a 510K clearance for the Encompass Clamp. This device is an innovative addition to our open ablation platform, where we are the market leader in cardiac surgery procedures for the treatment of AFib. The Encompass Clamp provides a simpler and faster approach to ablating the heart in open procedures, and we expect the device will have broad appeal to high-volume cardiac surgeons, deepening our penetration in the cardiac surgery market over the next decade. We have begun a limited launch at a small number of centers and expect to move to full commercial launch later this year. It was nearly a decade ago that AtriCure's isolator synergy system was approved by the FDA for the concomitant surgical treatment of persistent and long-standing persistent AFib. With the recent approval of Epicense system for hybrid AF therapy, Atracure has the only two devices in the world with FDA approval for the treatment of longstanding persistent AFib, providing a clear advantage for our open and minimally invasive ablation platforms. So let me pause here to reiterate a message from our first quarter. The collective opportunity and addressable market for our ablation platforms is well into the billions of dollars, representing hundreds of thousands of patients annually. And while the ablation opportunity alone is meaningful, it is further boosted by the steady rise in left atrial appendage management procedures. Worldwide, our left atrial appendage management franchise delivered 23% sequential growth over the first quarter. We continue to be excited by increasing awareness of the need for left atrial appendage management and the growing body of clinical evidence, including a recent independent LAA occlusion study that was published in the New England Journal of Medicine and presented as a late breaker in May at the American College of Cardiology annual meeting. This was the first randomized control study to demonstrate that surgical LAA management for AFib patients undergoing cardiac surgery with surgical approaches or the atrial clip significantly reduces ischemic stroke and systemic embolism. Over 4,700 patients were part of the study at 105 different centers in 27 countries. Surgical left atrial appendage management occlusion was found to reduce ischemic stroke by 33% overall and by 42% after the first 30 perioperative days. Importantly, there were no significant safety issues identified in the study. Additionally, we welcome positive reimbursement news for surgical left atrial appendage management with the proposal by the CMS for the new current procedural terminology or CPT codes. We believe this change reflects a groundswell of support from key societies and positions creating another tailwind for the H-Equip franchise when the proposed rates take effect in 2022. And finally, touching on 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 cardiothoracic surgery, providing a long-lasting form of pain relief for patients. Crown nerve block, which is included in our open franchise revenue, is one of our fastest-growing therapies and now represents approximately 7% of worldwide revenue year-to-date. Nearly 400 facilities in the U.S. are changing their standard of care to incorporate this unique approach to pain management. We are pleased with the traction we are seeing in the existing accounts and the ongoing expansion to new customers. Yes, this is great progress, but we believe the market for crown nerve block therapy still remains widely underpenetrated. As a result, we are continuing to increase our investments in our dedicated commercial and education teams as we drive therapy awareness and adoption. In closing, we are truly excited by our broadening portfolio and bright future ahead. While we continue on a pathway toward recovery, we remain confident in the underlying strength of our business, the resiliency of our team, and our many catalysts to accelerate growth in 2022 and beyond. I will now turn the call over to Angie Weirich, our Chief Financial Officer, to discuss more detailed results of the quarter.