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AtriCure, Inc.
7/28/2020
Good afternoon, and welcome to the Atricure's second quarter 2020 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 today's call. 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 Gilmerton 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 the company's remarks include forward-looking statements. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond Atricure's control, including risks and uncertainties described from time to time in Atricure's SEC filings. 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 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?
Thank you, Lynn. Good afternoon, and thank you for joining us. We hope you are staying safe and healthy as we continue to face unprecedented challenges with this pandemic. Before we begin our quarterly review of our results, we want to express our gratitude to the selfless workers on the front lines who continue to rise to the occasion to keep our communities safe and functioning. Thank you for taking care of us. You are the true heroes. We are encouraged by our second quarter results despite the impact and challenges of COVID-19, which we felt especially early in the quarter. Total revenue was just under $41 million, down 31% from the same period last year. We experienced a trough in April, with monthly revenue down 54% as compared to April 2019 due to the significant slowdown of non-emergent procedures in response to COVID-19 pandemic in the U.S. and Europe. We began to see a rapid return in May, followed by steady volumes throughout June, with procedures coming back online and the easing of shelter-in-place restrictions. Specifically, in May, we saw revenue improve by nearly 50% over April, and in June, we saw a similar improvement over May. While we are pleased by the encouraging rebound of our business in the U.S. and parts of Europe through the second half of the quarter, the situation does remain fluid, especially with the recent trends indicating growing case volumes in some regions of the United States. In the last few weeks, we began to see more volatility in case volumes and now expect July revenue to be down somewhat compared to June. As we look to the second half of 2020, we remain cautiously optimistic about our outlook while continuing to make sure we stay flexible and ready to mitigate any interruptions, and we remain on track with all of our strategic initiatives. To that end, we continue to prioritize the health and safety of our employees, and promote remote working wherever possible. At the same time, we are easing spending restrictions in several areas. Specifically, we lifted a hiring freeze and are actively adding to our commercial team and other critical roles. We are focused on our future, on innovation, clinical science, and education, strengthening our commercial infrastructure to ensure that we are well positioned on all our future catalysts, such as the Converge Approval, and amaze progress as we enter 2021 and 2022. The strong performance in the second quarter is a testament to the resiliency of our team at Atricare. Our amazing group has risen to face these challenging times with an unwavering commitment to support our healthcare partners and to put patients first. I would like to highlight our clinical education team as one example of this dedication. Over the past year, our clinical education team has developed a peer-to-peer education platform that is second to none. In response to COVID-19 pandemic, our team quickly developed and validated a process to adapt this platform to support our customers virtually. As institutions across the country changed their policies and protocols, physicians also had to adjust to these changes. Our team at Atricure was helpful and prepared with this virtual platform and reached out proactively. Our customers could not stop thanking us for stepping up and showing that we care. This virtual platform for education became our outlet to continue to partner with clinicians as we could no longer call on our customers in person. We've been able to work with the medical community seamlessly, literally transitioning from in-person to remote engagement with our customers and building even stronger relationships as our team has been rising to the occasion. While managing through the pandemic, we were successful in achieving several milestones during the quarter and made significant progress on our strategic initiatives. Starting with Converge. As many of you are well aware, the data readout from the Converge trial was presented during the virtual HRS conference in early May. The response from the medical community has been tremendous. As an example, Radcliffe Group recently held a virtual symposium on our Convergent procedure, which was endorsed by the British Heart Rhythm Society and accredited by the European Board of Accreditation in Cardiology. We were excited that the seminar drew over 900 physicians, the largest group of attendees we have ever witnessed for a seminar of NEH secure procedure. Further, with respect to Converge, a number of clinical papers were published in the Arrhythmia and Electrophysiology Review. A manuscript was submitted to the Journal of American College of Cardiology, and a second analysis of Converge was submitted to the American Heart Association. We believe this level of interest clearly demonstrates that the data is driving deeper discussions around the best treatment options for patients suffering from persistent and longstanding persistent AFib, which is central to our patient-first mission. There is still work ahead, and our team is diligently working with the FDA to complete the regulatory process to make this therapy available to patients suffering from advanced forms of AFib. We've had very productive and collaborative discussions with the FDA, Following the data release at HRS in May, we've engaged in deeper dialogue with the agency asking additional questions and for some additional analytics. We are encouraged by these discussions and are reminded of the strength and durability of our data, both in terms of safety and efficacy. That said, there are a lot of moving parts before the regulatory process is complete. We are still working under the assumption that the FDA will convene a panel meeting, but we do not have insight as to the potential timing of this meeting. At this point, our expectation is it will be a little bit further out than we had originally anticipated. We made significant progress in our other market-changing clinical study as well, the AMAZE trial, passing a major milestone by preparing and submitting our first module of the PMA to the FDA. As a reminder, the AMAZE trial is a 600-patient randomized control trial designed to show superiority. Superiority for this trial is catheter ablation plus Atricher's Lariat LAA exclusion system versus catheter ablation alone. We completed enrollment in the trial in December 2019 and expect to have follow-up on these patients in early to mid-2021, followed by data analysis and our full PMA submission. In addition to progress with the CONVERGE and AMAZE trials, both of which we believe will be transformative for the company, We are making steady progress pushing forward important initiatives that augment our core ablation business. In the second quarter, our innovative cryosphere probe continued its positive upward trend in revenues. The cryosphere probe is intended for managing post-operative pain in cardiothoracic patients. This unique probe demonstrates our investment in innovation and its resulting impact to our business. To support the increasing case volume, we continue to steadily add sales and clinical resources to our thoracic team. We believe that our cryonerve block therapy is rapidly gaining momentum in thoracic pain management market and expect meaningful contribution in the long term. As part of the open ablation platform, we are continuing to work toward the 510K clearance of our new Encompass clamp, and our team is preparing for a subsequent market launch. The Encompass clamp provides a simpler and faster approach to ablating the heart in open procedures. We expect this clamp to appeal to high-volume cabin surgeons and to contribute to our open ablation revenue in the coming years. What does this all mean in the current environment? We are continuing to strengthen our clinical evidence, educating, education and training, and product innovation. And as I mentioned earlier, to further support the expansive growth of our initiatives, we continue to actively build our teams, hiring strategically throughout the second half of this year. However, our optimism for the future is balanced by the uncertainty of the present environment. We saw a possible plateau in procedure volumes as we entered into July with increased volatility and mixed results through key markets. As a result, we remain measured in our outlook for Q3 and the remainder of the year, and we are not providing financial guidance for 2020 at this time. We are actively monitoring the evolving environment and trends remain flexible throughout and we remain flexible and prepared to effectively respond to the pandemic. While we cannot predict when we will return to normalcy, we are confident that our future is extremely bright, our team remains focused, and our business continues to be poised for long-term growth and success. I'll now turn the call over to Andy Wade, our Chief Financial Officer.
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