EDAP TMS SA - EDAP STOCK NEWS

EDAP TMS SA (Nasdaq: EDAP) announced unaudited financial results for Q1 2023, with total revenue of EUR 14.8 million, a 13.8% increase compared to Q1 2022. The HIFU business revenue increased by 39.5% driven by the sale of six Focal One units. The LITHO business revenue improved due to the sale of four lithotripsy units. The Distribution business revenue decreased slightly. Gross profit margin was 40.8%, lower than the previous year due to investments in service and applications in the U.S. Operating expenses increased significantly to EUR 12.6 million, mainly due to the ongoing build-out of the U.S. team and non-recurring expenses related to the leadership succession plan. The company reported an operating loss of EUR 6.6 million and a net loss of EUR 7.5 million. Cash and cash equivalents were EUR 58.3 million as of March 31, 2023.

EDAP TMS SA (Nasdaq: EDAP) announced it will showcase its Focal One® Robotic High Intensity Focused Ultrasound (HIFU) platform for prostate cancer management at the Annual Meeting of the American Urological Association (AUA), scheduled for April 28-May 1 in Chicago, IL. This year, EDAP will have its largest presence at the AUA, featuring Focal Therapy discussions and hands-on demonstrations. Key urologists will present the advantages of HIFU therapy, emphasizing its efficacy in meeting oncological standards while preserving patient quality of life. The AUA meeting highlights the ongoing clinical acceptance and adoption of EDAP's technology among physicians worldwide.

EDAP TMS SA (Nasdaq: EDAP) announced a webcast scheduled for April 18, 2023, at 12:00 p.m. PDT, showcasing its Focal One HIFU technology for prostate cancer treatment. The live demonstration will be conducted by Dr. Andre Abreu and Dr. Amir H. Lebastchi from Keck Medicine of USC, highlighting advancements in non-invasive treatment options. CEO Ryan Rhodes emphasized the importance of collaboration with leading academic centers to enhance patient outcomes through innovative therapies. USC has been instrumental in adopting EDAP's technology, focusing on the effectiveness and quality of life improvements for prostate cancer patients. The webcast aims to educate healthcare professionals on best practices in using robotic high intensity focused ultrasound (HIFU) for precise cancer treatment.

EDAP TMS has received approval from Japan's PMDA for the commercialization of its ExactVu™ micro-ultrasound biopsy platform. This platform is significant as it offers the only micro-ultrasound technology for precision prostate biopsies, a critical need considering Japan has over 100,000 new prostate cancer diagnoses annually. The ExactVu utilizes a unique 29MHz frequency, allowing for detailed visualization of prostate tissues during biopsies. With its existing sales in the EU and the US, this expansion into Japan taps into the world's second-largest market for advanced medical devices. CEO Marc Oczachowski expressed confidence in their commercial team's ability to engage clinical sites effectively.

EDAP TMS reported record total revenue of EUR 55.1 million ($58.0 million) for 2022, marking a 25.1% increase over 2021. The HIFU segment saw a significant rise, achieving EUR 15.6 million ($16.4 million), up 57.7%. Q4 2022 revenue reached EUR 15.7 million ($16.2 million), an increase of 12.8%. Operating loss widened to EUR 4.3 million ($4.5 million) for 2022, compared to a loss of EUR 1.6 million ($1.9 million) in 2021. The company had a strong cash position of EUR 63.1 million ($67.5 million) as of December 31, 2022. Additionally, Ryan Rhodes will take over as CEO on May 1, 2023.