AtriCure, Inc.

Good afternoon and welcome to HRCARE Q4 and full year 2019 earnings conference call. My name is Dilem and I'll be your coordinator for the call today. 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 has been recorded for replay purposes. I would now like to turn the call over to Lynn Lewis from Gilmartin 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 HRCure's control, including risks and uncertainties described from time to time in HRCure's SEC filings. HRCure'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 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, and thank you for joining us today. As I reflect on 2019 and as we usher in a new decade, I'm struck by the transformational development at ACRE over the past 10 years. While concentrating our efforts on the three pillars of our mission, innovation, clinical science, and education, we have made tremendous progress on multiple fronts and have meaningfully expanded our market opportunity. Some of these highlights include we have achieved 29 consecutive quarters of double-digit revenue growth year over year. We diversified and bolstered our product portfolio, launching over 12 new products and innovations, beginning with the launch of the AtriaClip franchise 10 years ago and strengthened more recently by the launch of Cryosphere for cryonerve block therapy in 2019. We completed significant acquisitions, including in contact in 2015 and most recently in August 2019, Central Heart with the Lariat suture device. We have invested heavily in clinical trials to develop significant differentiation for the treatment of AFib over the long term. We have trained over 3,000 physicians, nurses, and other practitioners globally through our training programs, which were recently endorsed by the Society for Thoracic Surgeons in early 2019. And finally, we have built the infrastructure and team to support accelerated growth and ongoing expansion. We now have 725 people across the organization, including over 200 in the field globally supporting our sales. We have built a winning foundation and achieved critical milestones setting the stage for success across our franchises in 2020 and over the next decade. To that end, and as previously announced, we expect another year of double-digit revenue growth in 2020 with revenue in the range of $254 to $261 million. Turning now to our landmark IDE trials we have underway, which address market-expanding opportunities, both Converge and Amaze. Through these two clinical trials, we are the only company attempting to treat the most difficult patient population. The 70% of AFib patients that have persistent and long-standing persistent AFib, where catheter ablation alone is typically not effective. Treatment of this patient population remains vastly underpenetrated and represents well more than a billion dollars of market opportunity today. As it relates to the CONVERGE trial, we submitted our final PMA module to the FDA at the end of 2019. The results will be submitted to be released as part of late-breaking presentations at the Heart Rhythm Society meeting in early May. To remind everyone, Converge is a 153-patient superiority trial. It's a randomized controlled trial, the first of its kind, and quite frankly, the only one in the market today. We are comparing our approach, which is a hybrid procedure combining catheter ablation with our Epicense technology versus catheter ablation alone. We continue to prepare for a potential panel and are optimistic that we could receive FDA approval toward the end of 2020. Our other market-changing trial, AMAZE, is a 600-patient randomized controlled trial also designed to show superiority. Superiority in this case is catheter ablation plus the Lariat technology, which excludes the appendage versus the catheter ablation alone. Thank you for watching. We completed enrollment in AMAZE in December 2019 and expect to have follow-up on those patients in early to mid-2021, followed by data analysis and our full PMA submission. Under this timeline, we are hopeful we could receive FDA approval sometime in 2022. I will finish my remarks on these key clinical trials by emphasizing that we are not competing against catheter companies. Both of our solutions are complementary and used in conjunction with catheters. We believe both procedures will help grow and expand the overall market, and more importantly, the number of patients that can get treated more so than today. Now, moving on to our full year and fourth quarter results. Our performance remains strong. We closed out 2019 with $231 million in revenue, up 14% annually and capped off by fourth quarter revenues of $61 million and 16% growth over Q4 2018. U.S. strength was again broad-based, driven by our appendage management franchise. In particular, our V-clip line of products continue to be additive to our growth in appendage management. Both the open chest and minimally invasive version of the V-clip continue to grow nicely as the benefits of the ease of placement of those devices are recognized by our customers. We also saw strong growth internationally in our appendage management business, and we are excited about continued prospects as we have full-year V-clip products being available in Europe after securing CE Mark in late 2019. We continue to focus on accelerating growth within our open ablation platform. As such, we recently submitted our 510K to the FDA on our new open clamp and compass and remain on track to launch later this year. This new clamp will provide a simpler and faster approach to ablating the heart in open procedures and we expect it to resonate with cabin surgeons in the open concomitant space and to be accretive to our open ablation revenue in future years. The Cryosphere Probe, our dedicated device for managing post-operative pain in cardiothoracic surgical patients, once again contributed to our open ablation platform growth in the fourth quarter. This growth is encouraging despite the fact that the overall revenue contribution from the Cryosphere Probe is small. To build the pain management account base, we are continuing to expand our thoracic team in select markets. We can see that the therapy is clearly resonating with our customers and continue to see long-term growth opportunities in this space. Transitioning to our minimally invasive ablation business, revenues were slightly down year over year. In 2020, we expect volatility in this franchise will continue. Longer term, we believe FDA approval of our EpiSense system via the converged trial in treating symptomatic, persistent, and long-standing persistent AFib patients will provide meaningful growth in the minimally invasive ablation franchise. Now looking at our other supporting clinical programs, which are focused on markets, which we are in today, with the goal of obtaining additional labeling. We initiated our iSAFEB clinical trial in 2019, and we have a total of nine sites actively enrolling. We expect that successful completion of this trial will generate systematic clinical evidence on the safety and effectiveness of concomitant cryosurgery for the treatment of AFib patients undergoing structural heart surgery. We also continue to make progress in our DEEP-AF IDE trial with 15 sites now enrolling. As a reminder, DEEP-AF provides another alternative for minimally invasive approaches. We believe that the successful conclusion of each of these studies in which we are partnering with some of the best institutions globally, provides an opportunity to further support our comprehensive platform and increased awareness to promote expansion of available therapies. Internationally, fourth quarter results were positive, primarily driven by appendage management and open franchises. Throughout 2019, we strengthened our position in Asia with growth in Japan, led by our Acerclip and Cryo-ICE device sales, and in China with our partner, Bahio, and the expansion of our team. In Europe, especially the UK, France, and Germany, we saw expanded growth of EpiSense and Atriclip products and steady growth in the open ablation franchise. In summary, our future is bright with our overall performance throughout 2019 reflecting our continued product portfolio investment and expansion. I want to now turn the call over to Andy Wade, our Chief Financial Officer, to review our financials and outlook, and we'll turn for closing comments.