LYON, France, August 29, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced that Ryan Rhodes, Chief Executive Officer, is scheduled to participate in a fireside chat and host 1x1 investor meetings at the H.C. Wainwright 26th Annual Global Investment Conference, which is being held September 9-11, 2024, in New York City. | --- | --- | |-------|---------------------------------------| | | | | | Date: Tuesday, September 10th | | | Time: 3:00-3:30 PM ET | | | Locat ...

EDAP TMS S.A. (NASDAQ:EDAP) Q2 2024 Results Conference Call August 28, 2024 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors Ryan Rhodes - Chief Executive Officer Ken Mobeck - Chief Financial Officer Francois Dietsch - Chief Accounting Officer Conference Call Participants Michael Sarcone - Jefferies Joseph Downing - Piper Sandler RK Ramakanth - H.C. Wainwright Operator Good day, and welcome to the EDAP TMS Second Quarter 2024 Earnings Conference Call. All participants will be in a listen-onl ...

Financial Performance - Record Q2 2024 total worldwide revenue of EUR 15.8 million (USD 17.0 million), an increase of 10.6% over Q2 2023 [1] - Record first half 2024 total worldwide revenue of EUR 30.7 million (USD 33.1 million), an increase of 5.6% over the first half of 2023 [1] - Gross profit for Q2 2024 was EUR 5.9 million (USD 6.4 million), with a gross profit margin of 37.5%, down from 39.6% in Q2 2023 [16] - Operating loss for Q2 2024 was EUR 6.1 million (USD 6.6 million), compared to an operating loss of EUR 4.2 million (USD 4.6 million) in Q2 2023 [18] - Net loss for Q2 2024 was EUR 6.1 million (USD 6.6 million), or EUR (0.16) per share, compared to a net loss of EUR 4.7 million (USD 5.1 million), or EUR (0.13) per share in Q2 2023 [18] Business Updates - Strong Q2 2024 U.S. Focal One® HIFU procedure growth of +63% year-over-year [1] - Five Focal One systems were placed in Q2 2024, including placements with two additional National Cancer Institute designated comprehensive cancer centers [2] - The company appointed Fran Schulz to its Board of Directors, bringing over 35 years of experience in the life sciences industry [5] - Marc Oczachowski resigned as Chairman of the Company's Board of Directors effective September 30, 2024 [4] Clinical Developments - The HIFI study results presented at EAU and AUA meetings indicate that Focal One robotic HIFU is at least as effective as radical prostatectomy for localized prostate cancer, with potential for improved functional outcomes [3] - Interim results from a Phase 3 study on robotic HIFU for deep infiltrating endometriosis show positive safety data, although the primary endpoint of reduced acute pelvic pain was not met [9][10] - Approval received from the French National Agency for Medicines and Health Products Safety to initiate a Phase 1-2 Clinical Trial for Focal One Robotic HIFU in treating Benign Prostate Hyperplasia [11] Revenue Breakdown - Total revenue in the HIFU business for Q2 2024 was EUR 4.8 million (USD 5.2 million), compared to EUR 4.9 million (USD 5.3 million) in Q2 2023, with a 29.4% year-over-year growth in worldwide disposables revenues [13] - Total revenue in the Distribution business for Q2 2024 was EUR 8.7 million (USD 9.4 million), an increase from EUR 7.2 million (USD 7.8 million) in Q2 2023 [14] - Total revenue in the LITHO business for Q2 2024 was EUR 2.3 million (USD 2.5 million), slightly up from EUR 2.2 million (USD 2.4 million) in Q2 2023 [15] Upcoming Events - A conference call and webcast to discuss the second quarter 2024 financial results will be hosted on August 28, 2024, at 8:30 a.m. EDT [24]

Core Viewpoint - EDAP TMS SA will release its financial results for Q2 2024 on August 28, 2024, before market opening, and will host a conference call to discuss these results [1][2]. Group 1: Financial Results Announcement - The financial results for the second quarter ended June 30, 2024, will be announced before the markets open on August 28, 2024 [1]. - A conference call and webcast will be held on the same day at 8:30 am EDT, featuring key executives [2][3]. Group 2: Conference Call Details - The conference call will be led by CEO Ryan Rhodes, CFO Ken Mobeck, and Chief Accounting Officer François Dietsch [2]. - Dial-in information includes a domestic number (1-877-300-8521) and an international number (1-412-317-6026), with a passcode of 10190872 [3]. Group 3: Company Overview - EDAP TMS SA is a leader in the global therapeutic ultrasound market, focusing on minimally invasive medical devices for various pathologies [4]. - The company offers a complete solution for prostate cancer treatment, including the Focal One® and ExactVu™ Micro-Ultrasound devices [4]. - EDAP TMS also produces other medical equipment, such as the Sonolith® imove lithotripter for treating urinary tract stones [4].

Semi-Live Focal One Procedure to be Conducted on August 15th at 5:00 pm (KST) LYON, France, August 6, 2024 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, today announced that the Company's leading robotic HIFU technology platform, Focal One, will be featured at the 41st World Congress of Endourology and Uro-Technology (WCET 2024) meeting, taking place in Seoul, South Korea, from August 12-16, 2024. "Our leading Focal One platform continues to generate strong interest from ...

LYON, France, July 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced interim results from its Phase 3 study evaluating robotic High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating endometriosis. The Phase 3 study is a 60- patient comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels. All patients were initially followed for three months after either the HIFU t ...

Robotic HIFU therapy continues to maintain an excellent safety profile, confirming positive safety data from prior Phase 1 and 2 studies in patients with deep infiltrating endometriosis At three months post procedure, the study's primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met Significant improvements were observed across primary and secondary outcome measures (endometriosis and digestive symptoms) across the entire study population at t ...

New appointments bring significant commercial experience with a focus on growing key strategic markets Expands executive leadership in growing disruptive, robotics-based capital equipment in both Urology and Gynecology therapeutic applications LYON, France, June 3, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the appointments of Damien Desmedt and Alexander Fromm to further strengthen the Company's European and Middle Eastern commercial leadership. ...

EDAP TMS (NASDAQ:EDAP) Q1 2024 Earnings Call Transcript May 16, 2024 8:30 AM ET John Fraunces - LifeSci Advisors Ryan Rhodes - Chief Executive Officer Ken Mobeck - Chief Financial Officer Michael Sarcone - Jefferies Frank Takkinen - Lake Street Capital Jason Bednar - Piper Sandler Swayampakula Ramakanth - HC Wainwright Greetings and welcome to the EDAP TMS First Quarter 2024 Earnings Conference Call. At this time. all participants are in a listen-only mode. A brief question-and-answer session will follow th ...

LYON, France, April 23, 2024 - EDAP TMS SA (NASDAQ:EDAP), the global leader in robotic energy-based therapies, announced that final results from the HIFI Study, the largest clinical trial ever conducted comparing EDAP's Focal One robotic high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for the treatment of prostate cancer, will be presented during a plenary session at the 119th American Urological Association Annual Meeting (AUA 2024), which is taking place from May 3-6, 2024, in S ...