EDAP TMS S.A.

Greetings. Welcome to EDAP TMS fourth quarter and full year 2021 earnings conference call. At this time, all participants are in a listen-only mode. A 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. Please note this conference is being recorded. I would now like to turn the conference over to John Francis, Investor Relations. Thank you. You may begin.

Thank you. Good morning and thank you for joining us for the EDAP TMS's fourth quarter 2021 financial and operating results conference call. On today's call, we will hear from Mark Oksakowski, Chief Executive Officer and Chairman of the Board, Ryan Rhodes, Chief Executive Officer of EDAP U.S., and Francois Adiche, Chief Financial Officer. Before we begin, I would like to remind everyone that management's remarks today may contain forward-looking statements. which includes 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 Arkzakowski. Mark?

Thank you, John, and good morning, everyone. I will start by providing a brief operational update before turning the call over to Ryan Rose, our EDAP U.S. Chief Executive Officer, for a review of the U.S. business and strategy, and then François Ditch, our CFO, will present our financial performance. I will start by recapping a few of the highlights. Full year 2021 revenue was 44.1 million euros, or $51.9 million as compared to full-year revenue of 41.7 million euros or $47.8 million for the full year 2020, an increase of 5.8%. While Ryan will cover developments in the U.S. business, it is worth noting that we exhibited 2021 with significant momentum. We placed Focal One machines with several new and highly regarded healthcare institutions that we believe serve as validation for the need of focal one as part of a comprehensive prostate oncology program. For the fourth quarter, total revenue was 14 million euros or $15.9 million, representing a decrease of 9.1% as compared to the fourth quarter of 2020. The fourth quarter did offer 48% growth in sequential revenue from Q3 2021, though we do tend to see the fourth quarter as a more favorable time for closing capital purchases. As I mentioned a moment ago, we are very pleased with the momentum with which we exceeded the fourth quarter and entered 2022. Focal 1 is gaining acceptance as the most advanced non-invasive treatment for prostate ablation controlled by the urologist. Our focused investment in the U.S. market is delivering results, and our distribution business is growing globally, especially in regards to the ExactView micro-ultrasound platform. At this point, I would like to provide an update on our expansion activities where we believe HIFU can have clinical utility and indications outside of prostate cancer. We are currently running a Phase II study evaluating HIFU using the FocalOne platform for the treatment of deep infiltrating endometriosis. We are very happy to announce today that we completed enrollment and treatment of 60 patients. The last treatment was done just two days ago. These 60 patients were treated across four major hospitals in France and will be assessed over a six-month follow-up period, likely concluding at the end of September of this year. Investigators are evaluating the safety and efficacy of HIFU for this pathology. 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, and it is becoming a major issue in women's health worldwide. We also announced in January the publication of positive preclinical results using intraoperative HIFU ablation of the pancreas in the journal Cancers. The study was designed to assess the feasibility of using HIFU under Doppler guidance to treat the pancreatic parenchyma and tissues surrounding the superior mesenteric vessels in vivo in an animal model. Pancreatic adenocarcinoma is among the most aggressive of all cancers. Regardless of treatment, the overall five-year survival rate for patients with locally advanced pancreatic adenocarcinoma is less than 5%. The HIFU approach could help in the treatment of such pathology that is inaccessible by other known therapeutic methods. The paper's authors conclude that the possibility of treating the pancreas using HIFU holds great promise for the treatment of locally advanced pragmatic cancer. We are very excited to further explore the possible utility of HIFU in these very difficult to treat cancer and build upon these findings. Finally, and as a quick note, we successfully treated the first two patients yesterday at Lyon-Édouard-Aieu University Hospital in a clinical trial to evaluate feasibility and safety in using our FOCAL-1 robotic HIFU device for the treatment of benign prostatic hyperplasia, or BPH. We will keep you posted as we move forward with this new clinical study. With $53.4 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, our CEO of EDAP-US, whom I would like to congratulate for a strong finish to 2021 and a promising start to 2022. With a full pipeline of projects well supported by a newly hired team of talented sales experts, Ryan will give us an update of our U.S.