EDAP TMS S.A.

Greetings and welcome to the EDAP TMS fourth quarter and full year 2022 earnings conference call. At this time, all participant lines 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, Managing Director of LifeSci Advisors. Please go ahead.

Good morning. Thank you for joining us for the EDAP TMS fourth quarter and full year 2022 Financial and Operating Results Conference Call. On today's call, we'll hear from Mark Oksakowski, Chief Executive Officer and Chairman of the Board, Ryan Rhodes, Chief Executive Officer of EDAP-US, and Francois Dietsch, Chief Financial Officer. Before we begin, I would 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 Oksakowski. Mark?

Thank you, John, and good morning, everyone. I'll start by providing some operational highlights of our fiscal year 2022 and then turn the call over to Ryan Rhodes, our EDAP U.S. Chief Executive Officer, who will review our U.S. business and strategy. Our Chief Financial Officer, Francois Ditch, will then present our financial performance. Thanks to the continued hard work of our dedicated employees and the growing acceptance of our technology, 2022 was a great year for setting new records at EDAP. During the fourth quarter, we generated record revenue of 15.7 million euros or 16.2 million dollars for the year. and we announced record revenue of 55.1 million euros, or 58 million dollars, representing year-over-year growth of over 25%. Without question, our strong top-line performance was driven by our high-intensity focused ultrasound, or HIFU, segment that grew by 58% compared to 2021. The HIFU growth was particularly strong in the U.S., as Ryan and his team continue to execute by expanding the number of medical centers that are now using our therapeutic ultrasound solution, focal one, robotic focal HIFU. As the global leader in therapeutic HIFU, EDAP enjoys a significant technology advantage in the marketplace. And we continue strong market execution. We anticipate momentum in the form of increased system placement and utilization will continue throughout 2023. Our distribution segment also performed very well during the fourth quarter. We sold 11 executive units during the quarter as compared to nine in the fourth quarter of 2021. This is concluding a strong year for the executive business as we doubled our system sales as compared to 2021. I'd now like to provide an update on our pipeline where we continue to make significant progress in demonstrating the utility of therapeutic HIFU beyond prostate cancer. In January, we announced positive clinical results from the endo-IFU phase 2 study, evaluating the safety of therapeutic HIFU for the treatment of rectal endometriosis. Results from the trial served to validate the safety of 4.1 HIFU treatment in this difficult and challenging endometriosis population. The study enrolled 60 patients across four centers in France between August 2020 and March 2022. and the results were based upon a six-month follow-up evaluation post-HIFU treatment. Study coordinator, Professor Gilles Dubernard of Croix-Rouge University Hospital in Lyon, France, presented results from the study on January 27 at the Paris Centre Femme French Congress in Lyon, France. As previously announced, treatment with 4x1 resulted in significant improvements in endometriosis symptoms and quality of life. In addition, the treatment had a very positive safety profile with 96.7% of patients with no or non-significant adverse events. Finally, the study also blindly evaluated the evolution of nodule volume via MRI, and a significant reduction of the volume of lesions was observed at six months. Based on this positive safety and preliminary efficacy data, We intend to compare the efficacy of FOCAL-1 high-food treatment in rectal endometriosis by initiating a Phase III study in the second quarter of 2023. As a Level I study, this trial will be a multicenter, double-blind, randomized, controlled clinical trial that will enroll 60 subjects across 8 centers in France, with 30 subjects randomized to each group. The primary efficacy endpoint is acute pelvic pain three months post-procedure. If successful, this rigorously designed study will provide a strong clinical evidence to date demonstrating the utility of therapeutic high proof to address this painful and debilitating condition. As a reminder, the standard of care treatment of deep infiltrating endometriosis typically involves surgical resection of the bowel or rectum. which is a highly invasive procedure that presents risk to the patient along with significant recovery time. We believe the use of our focal one robotic hypotechnology could greatly improve the treatment of complex endometriosis by offering patients a less invasive treatment option without the morbidity and possible side effects associated with surgery. We look forward to the results from this important study. As we execute our On our commercial strategy and grow our pipeline, we are doing so from a position of increasing financial strength. We ended the year with $67.5 million in cash, which was practically unchanged from the prior quarter. As our business continues to grow, both with respect to increased system placement and higher utilization, we expect to maintain a strong balance sheet while making an appropriate level of investments to further drive top-line growth and expand operating margins. As announced earlier today by our press release, the Board of Directors decided to change the leadership of the company to further develop ADAPT's global growth strategy, focusing particularly on its continued extension in the United States and in the rest of the world market. The board has therefore appointed Ryan Rhodes, Chief Executive Officer of CDAP TMS, effective May 1st of 2023, to lead, strengthen, and accelerate this important global commercialization strategy. The company has now reached an important inflection point in its growth trajectory and needs a strong, focused, and aggressive strategy to be executed. The board of directors and myself are confident that Ryan has the capability, the experience, and skills to lead this new and higher state of development for EDAP and high-speed adoption. I am pleased and committed in continuing to serve as chairman of the board of the company. At this point, I would like to turn the call over to Ryan Rose for an update on our U.S. operations and activities. Ryan?