EDAP TMS S.A. (NASDAQ:EDAP) Q3 2022 Earnings Conference Call November 17, 2022 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors, IR Marc Oczachowski - CEO and Chairman of the Board of Directors Ryan Rhodes - CEO, EDAP US Francois Dietsch - CFO Conference Call Participants Michael Sarcone - Jefferies Jason Bednar - Piper Sandler Frank Takkinen - Lake Street Capital Markets Sean Lee - H.C. Wainwright Operator Greetings and welcome to EDAP TMS Third Quarter 2022 Earnings Call. At this time, all ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 November 16, 2022 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [x] Form 40-F [ ] Indicate by check mark i ...

EDAP TMS S.A. (NASDAQ:EDAP) Q2 2022 Earnings Conference Call August 25, 2022 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors, IR Marc Oczachowski - CEO & Chairman of the Board of Directors Ryan Rhodes - CEO, EDAP US Francois Dietsch - CFO Conference Call Participants Frank Takkinen - Lake Street Capital Jason Bednar - Piper Sandler Swayampakula Ramakanth - H.C. Wainwright Operator Greetings. Welcome to EDAP TMS Second Quarter 2022 Earnings Conference Call. At this time, all participants are ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 August 24, 2022 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ x] Form 40-F [ ] Indicate by check mark if ...

EDAP TMS S.A. (NASDAQ:EDAP) Q1 2022 Earnings Conference Call May 18, 2022 8:30 AM ET Company Participants John Fraunces - LifeSci Advisors, Investor Relations Marc Oczachowski - Chief Executive Officer and Chairman of the Board of Directors Ryan Rhodes - Chief Executive Officer, EDAP US Francois Dietsch - Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Operator Greetings. And welcome to the EDAP TMS First Quarter 2022 Earnings Conference Call. At this time, all part ...

Table of Contents As filed with the Securities and Exchange Commission on April 8, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(B) OR (G) OF THE SECURITIES EXCHANGE ACT OF 1934, OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transiti ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 March 30, 2022 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ x] Form 40-F [ ] Indicate by check mark if ...

Financial Data and Key Metrics Changes - Year-to-date revenue for the nine months ended September 30th was €30.1 million, or $35.9 million, representing growth of 14.4% over the first nine months of 2020 [6] - Total company revenue for the third quarter was €9.4 million or $11.1 million, essentially flat compared to the year-ago period [7] - Gross profit for the third quarter of 2021 was €3.6 million, compared to €4 million for the year-ago period, with a gross profit margin of 38.4% [34] - Operating loss for the third quarter of 2021 was €1.9 million, compared to an operating loss of €0.3 million in the third quarter of 2020 [36] - Net loss for the third quarter of 2021 was €1 million or €0.03 per diluted share, consistent with the net loss of €1 million, or €0.03 per diluted share in the year-ago period [36] Business Line Data and Key Metrics Changes - Total revenue in the HIFU business for the third quarter of 2021 was €1.9 million, a decline of 25.6% compared to €2.6 million for the third quarter of 2020 [32] - Total revenue in the LITHO business for the third quarter of 2021 was €2.5 million, an increase of about 3% versus the third quarter of 2020 [33] - Total revenue in the Distribution business for the third quarter of 2021 was €5 million, a 13.4% increase compared to €4.4 million for the third quarter of 2020 [33] Market Data and Key Metrics Changes - US treatment volumes are up 68% over the same period in 2020, indicating growing adoption of Focal One HIFU as a prostate cancer treatment alternative [10] - The growth in US treatment volumes reflects the positive impact of HIFU category one CPT reimbursement code that went into effect on January 1 of this year [12] Company Strategy and Development Direction - The company is focused on increasing its US pipeline and establishing HIFU and the robotic Focal One device as the leading therapeutic tool in ablating prostate tissue [38] - A comprehensive action plan has been developed to demonstrate to CMS the benefits of HIFU technology, with the aim of securing increased facility reimbursement to level 6 starting in 2023 [14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that delays in machine placements were due to COVID-related restrictions, but expressed optimism about recognizing equipment sales in Q4 [8] - The company remains confident in its ability to navigate the challenging hospital CapEx environment and is optimistic about future sales and key placements [38] Other Important Information - The company held cash and cash equivalents of €45.4 million, or US$52.6 million, as of September 30, 2021, compared to €24.7 million, or US$30.2 million at the end of December 2020 [36] - The company is actively recruiting for its US commercial organization to enhance sales efforts [46] Q&A Session Summary Question: Sales funnel and penetration into Tier 1 accounts - Management indicated that discussions with Tier 1 hospitals are increasing, and more placements are expected in the near term [42] Question: Investment in the commercial organization - The company has added notable hires and is actively recruiting more skilled individuals to expand its sales personnel [46] Question: Reimbursement levels and expectations - Management discussed the potential for moving to APC level 6 reimbursement in 2023 based on improved treatment volumes and claims data [47][75] Question: Leading indicators of demand - Management noted that the addition of headcount and support for existing customers are contributing to a positive outlook for demand [52] Question: Challenges in the marketplace - Management stated that they are navigating supply chain challenges effectively and remain optimistic about improving gross margins [54] Question: Feedback from physicians and clinical data - Management highlighted the strength of clinical data supporting HIFU and its efficacy compared to traditional surgery [67]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 November 17, 2021 Commission File Number: 0-29374 EDAP TMS S.A. Parc Activite La Poudrette Lamartine 4/6 Rue du Dauphine 69120 Vaulx-en-Velin - France Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ x] Form 40-F [ ] Indicate by check mark ...

EDAP TMS S.A. (NASDAQ:EDAP) Q2 2021 Earnings Conference Call August 26, 2021 8:30 AM ET Company Participants Glenn Garmont - Investor Relations Marc Oczachowski - Chairman and Chief Executive Officer Francois Dietsch - Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets Jason Bednar - Piper Sandler Andrew D'Silva - B. Riley Operator Greetings and welcome to the EDAP TMS Second Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen- ...