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EDAP TMS S.A.
5/18/2022
Greetings and welcome to the EDAP TMS first quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, John Francis from Lifestyle Advisors. Thank you, John, and you may begin.
Good morning. And thank you for joining us for the EDAP TMS First Quarter 2022 Financial and Operating Results Conference Call. On today's call, we will hear from Mark Oksuchowski, Chief Executive Officer and Chairman of the Board, Ryan Rhodes, Chief Executive Officer of EDAP U.S., and Francois Adige, Chief Financial Officer. Before we begin, I'd like to remind everyone that management's remarks today may contain forward-looking statements, which include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. I would now like to turn the call over to EDAP's Chairman and Chief Executive Officer, Mark Oksuchowski. Mark?
Thank you, John, and good morning, everyone. I will start by providing a brief personal update before turning the call over to Ryan Rhodes, our EWS Chief Executive Officer, for a review of the U.S. business and strategy, and then Francois Ditch, our CFO, will present a financial performance. I will start by recapping a few of the highlights. For the quarter, we generated total revenue of 13 million euros, or $14.5 million, representing an increase of 26%, as compared to Euro 10.3 million or $12.4 million in the first quarter of 2021. The increase was driven by a very strong capital quarter, particularly in the U.S. We sold four Focal One robotic HIFU units during Q1 of 2022, as compared to zero in the year-ago period. Three of those sales occurred in the U.S., and one was OUS. We also sold nine exact units as compared to five in the year-ago period. By any measure, the first quarter was a very strong start to the year due to the investments we've made in our US team and infrastructure last year. I'm excited about the opportunity in front of us in 2022 and beyond. At this point, I would also like to provide an update on our expansion activities where we believe HIFU can have clinical utility and indications outside of prostate cancer. As a reminder, we are running a phase two study evaluating HIFU using the 4K1 robotic platform for the treatment of deep infiltrating endometriosis. We announced on our last quarterly update that we completed enrollment and patient treatments, so we are in the six-month follow-up period that will likely conclude at the end of September of this year. Investigators are evaluating the safety and efficacy of HIFU for this pathology. As we said before, we believe the treatment of endometriosis may be greatly improved and the use of HIFU technology could offer an important minimally invasive treatment option for these patients. The alternative for these patients is often an extensive surgical removal of the bowel. We look forward to results from this important study as HIFU could really add significant value in the management of complex endometriosis, for which there are no currently effective minimally invasive options. With over $51 million of cash, we are well-financed to continue to execute our U.S. growth and expansion plans, while in parallel exploring these and other clinical expansion opportunities. At this point, I would like to turn the call over to Ryan Rhodes, CEO of EDAP-US, for an update on our U.S.
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