7/30/2019

speaker
Operator
Conference Operator

Good afternoon, and welcome to Atra Hero's second quarter 2019 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 Gilmartin Group for a few introductory comments.

speaker
Lynn Lewis
Investor Relations, The Gilmartin Group

Thank you. Vinayak should have received a copy of the earnings press release. If you have not received a copy... Please call 513-755-4136 to have an email 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. HRCure 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?

speaker
Mike Carroll
President and Chief Executive Officer

Thanks, Lynn. Good afternoon, and thank you for joining us today. We are continuing the strong momentum from the start of 2019 with total revenue for the second quarter at $59 million, our 27th quarter in a row of double-digit revenue growth. Our top-line performance was driven by strength in our appendage management and open ablation franchises worldwide and highlights the diverse nature of our business. We continue to execute and achieve on our operational initiatives for 2019 and believe this quarter reflects the depth of our global team. As such, we are raising revenue outlook for 2019, which we now expect to be in the range of $224 to $228 million. This range corresponds to growth of 11% to 13% for the year. Turning to the U.S. business for the second quarter, we begin with our appendage management franchise. Growth in this franchise continues to be robust, with open and minimally invasive products both impacting our results. We have meaningful contributions from the minimally invasive Pro2 and ProV products, both launched in the last three years. The attachment rate of minimally invasive atrial clip devices and conversion procedures also continues to rise. In addition to the strong contribution from our minimally invasive atrial clip platform, the highlight for the quarter is the open chest FlexV device. It has been more than a year since we launched the FlexV in the U.S., and we remain pleased with the adoption and the extension of this product in the market. Results in the appendage management franchise demonstrate the substantial impact that previous investments and innovation are having on our business today. The Pro2, ProV, and FlexV products were part of a constant initiative to drive expansion with new platform products. We are clearly demonstrating traction with these new products, realizing immediate and sustainable contributions to our top line, all while strengthening our core portfolio. Turning next to our open ablation platform, we have been steadfast in our view that this opportunity is real, large, and underpenetrated. A recent publication in the Journal for Thoracic and Cardiovascular Surgery suggests that undertreatment and underdiagnosis is more significant than previously estimated. We believe this means even more patients could benefit from the treatment with Atricure therapies. We remain laser focused on education and training to support our efforts in penetrating this market. While Atricure MAZE training programs began over seven years ago, there continues to be robust interest from physicians and we repeatedly fill every course. In addition to extensive training course offerings, We had a strong presence this quarter at scientific meetings, including the Heart Rhythm Scientific Sessions, the Mitral Conclave, the American Association for Thoracic Surgery, and the International Society for Minimally Invasive Cardiothoracic Surgery. HRC devices and procedures were increasingly prominent at these meetings, which we believe signifies a positive change in view towards the treatment of AFib. Driven by our initiatives, and the Society Guidelines, we have seen steady growth from our legacy RF and cryo products within open ablation. Another demonstration of our investment in innovation and its impact is with Cryosphere. Open ablation results for the quarter were bolstered by the contribution from Cryo-ICE Cryosphere Probe, which we launched this past February. The Cryosphere is a device dedicated to blocking pain Thank you for joining us. We believe cryonerve block therapy is a particularly meaningful option now as finding alternatives to opioids are at the forefront of focus for many physicians and patients. While it is still early and the contribution is still small, cryonerve block therapy with cryosphere probe appears to be resonating with our customers, with revenues and new accounts are growing. We will continue to expand our small dedicated thoracic team to support crown nerve block therapy in select markets and have eight dedicated reps currently. We are receiving positive feedback from our customers and we expect the thoracic pain management market to offer significant opportunity over the long term. Transitioning to our MIS business, revenues were roughly flat as compared to the prior year in the United States. Thank you very much. As a reminder, the last patient was treated in August 2018, with all patients followed for one year post-treatment. For planning purposes, we continue to expect a panel and anticipating disclosure data around the time of that meeting. Also on the clinical front, we are forging ahead with enrollment in our ICE AFib clinical trial that began earlier this year. We have added six new sites for a total of nine sites actively enrolling. Successful completion of this trial will generate systematic clinical evidence on the safety and effectiveness of complement cryosurgery for the treatment of AFib patients undergoing structural heart surgery. Additionally, we are making progress in our deep AF-IDE clinical trial with up to 11 sites now enrolling. As a reminder, Deep AF provides another alternative for minimally invasive approaches. We believe our investments in these prospective clinical trials will reinforce our position as a leading innovator in the market. We are looking forward to the successful collusion of these trials and the opportunity to offer our technologies and therapies as a comprehensive platform to a dramatically expanded group of physicians and patients. As you can see, the diversification of our portfolio is driving our performance with consistently strong revenue growth. I will now turn the call over to Andy Wade, our Chief Financial Officer, and we'll return for closing comments.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-