Financial Performance and Profitability - The company achieved operational profitability in 2019 and 2020 but incurred operating losses in 2021 and 2022, indicating challenges in sustaining profitability[23]. - The company’s results of operations have fluctuated significantly due to long product sales cycles and various external factors, including healthcare reimbursement policies and exchange rate fluctuations[63]. - In 2022, 60% of the company's total costs of sales and operating expenses were denominated in euro, while 59% of sales were in currencies other than euro, primarily the U.S. dollar and Japanese yen[61]. - The company identified material weaknesses in internal controls over financial reporting for its U.S. subsidiary, which were due to insufficient resources in the finance department[66]. - The company has hired a Chief Financial Officer and a financial planning and analysis responsible person to address identified material weaknesses[70]. Market and Regulatory Environment - Future revenue growth is heavily reliant on the success of the HIFU technology, with a focus on expanding the HIFU business in the U.S. where it is FDA approved and reimbursed at an acceptable level[22]. - Regulatory approval processes for new products are lengthy and costly, with no assurance that the company will receive timely approvals, which could delay market entry[28]. - Changes in reimbursement policies by national health authorities could materially impact the company’s financial condition and results of operations[37]. - The company’s success is dependent on favorable reimbursement decisions from healthcare payers, with recent updates indicating reimbursement levels close to surgery for HIFU procedures effective January 1, 2023[36]. - The U.S. Centers for Medicare and Medicaid Services increased reimbursement for HIFU to Ambulatory Payment Classification level 6, effective January 1, 2023[106]. Research and Development - The company is investing in research and development to expand its product offerings, but there is no guarantee that these investments will yield significant operating income in the near term[26]. - The HIFU division's gross expenses increased by 36% in 2022 compared to 2021 for research and development projects[119]. - The company aims to expand HIFU applications beyond prostate cancer, exploring treatments for conditions such as rectal endometriosis and liver cancers[119]. - The company has initiated a Phase I study for benign prostatic hyperplasia (BPH) HIFU treatment, with six patients treated as of December 31, 2022[135]. - The company has published clinical results in peer-reviewed journals, confirming the safety and efficacy of HIFU treatments across various studies[141]. Supply Chain and Manufacturing - The company relies on a single manufacturing site in France, posing risks of operational interruptions that could adversely affect business[44]. - Key components are sourced from single suppliers, and any supply chain disruptions could negatively impact production and financial results[46]. - The company is renegotiating a supply agreement for ultrasound components due to significant price increases and is developing alternative options to mitigate supply risks[195]. - Manufacturing operations are conducted in an FDA-registered facility that complies with ISO 13485:2016 and MDSAP standards[192]. - The manufacturing facility in France is 4,150 square meters and is leased under a renewable ten-year agreement effective from July 1, 2015[198]. Competition and Market Position - Competition in the medical device market is intense, with competitors having greater resources and experience, which may affect the company's market position[41]. - The adoption of robotic HIFU devices by the medical community remains uncertain, impacting potential cash flows and profitability[38]. - The market for lithotripters is primarily a replacement and service market, with a focus on maintaining the installed base of ESWL lithotripters[179]. - The company has engaged in exclusive distribution agreements to enhance its product offerings, including a partnership with Exact Imaging for micro-ultrasound devices[188]. Risks and Compliance - The company faces significant risks of product liability claims, which could result in substantial financial liabilities and impact business reputation[54]. - Compliance with complex international regulations increases operational costs and risks, potentially affecting financial performance[55]. - The company is subject to healthcare laws regarding physician payment transparency and data protection, with non-compliance posing material risks to operations[57]. - Violations of data privacy laws could result in fines up to €20 million or 4% of the company's consolidated revenues for the preceding financial year, whichever is higher[58]. - The ongoing requirements of the Sarbanes-Oxley Act may strain the company's systems and resources, impacting its internal control effectiveness[68]. Strategic Initiatives - The company has decided to realign its activities and report financial results in three segments: HIFU, ESWL, and Distribution[100]. - The HIFU division's strategy includes building a direct sales network in key European countries and the U.S.[118]. - The company is currently reviewing its regulatory and market access strategy in China due to lengthy approval processes[129]. - The company established an exclusive distribution agreement in Russia to continue offering HIFU solutions, maintaining its existing installed base[80]. - The company raised gross proceeds of $28,012,500 from a public offering in April 2021, primarily to build U.S. clinical, sales, and marketing infrastructure[103].

EDAP TMS S.A. (NASDAQ:EDAP) Q4 2022 Results Conference Call March 30, 2023 8:30 AM ET Company Participants John Fraunces - Managing Director of Life Advisors Marc Oczachowski - Chief Executive Officer and Chairman of the Board Ryan Rhodes - Chief Executive Officer of EWS Francois Dietsch - CFO Conference Call Participants Michael Sarcone - Jefferies Frank Takkinen - Lake Street Capital Markets Swayampakula Ramakanth - H.C. Wainwright Operator Ladies and gentlemen, greetings, and welcome to the EDAP TMS Four ...

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, 2023 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 [ ] SIGNATURES Pursuant to the ...

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 ...

Revenue Performance - Total revenue for Q3 2022 was approximately EUR 12.2 million (USD 12.3 million), a 29.7% increase compared to EUR 9.4 million (USD 11.1 million) in Q3 2021[7] - Year-to-date revenue for the nine months ended September 30, 2022, was EUR 39.4 million (USD 41.7 million), a 30.9% increase from EUR 30.1 million (USD 35.9 million) in the same period of 2021[9] - Total net sales for the nine months ended September 30, 2022, increased to €39,391 thousand, up 30.5% from €30,088 thousand in the same period of 2021[24] Profitability - Gross profit margin for the nine months ended September 30, 2022, was 43.1%, up from 40.6% in the comparable period in 2021[11] - Gross profit for the nine months ended September 30, 2022, was €16,975 thousand, representing a gross margin of 43.1%, compared to €12,211 thousand and 40.6% in the prior year[24] - Net income for the nine months ended September 30, 2022, was EUR 2.2 million (USD 2.3 million), or EUR 0.07 per diluted share, compared to a net loss of EUR 0.7 million (USD 0.8 million) in the prior year[13] - Net income for the nine months ended September 30, 2022, was €2,197 thousand, compared to a net loss of €665 thousand in the same period of 2021[24] Operating Performance - Operating loss for the nine months ended September 30, 2022, was EUR 2.7 million (USD 2.8 million), compared to an operating loss of EUR 2.1 million (USD 2.5 million) in the same period of 2021[13] - Operating loss for the nine months ended September 30, 2022, was €2,687 thousand, compared to a loss of €2,073 thousand in the same period of 2021[24] - Operating cash flow for the nine months ended September 30, 2022, was €5,128 thousand, compared to €3,925 thousand in the same period of 2021[28] - The company reported a net cash generated by operating activities of €3,623 thousand for the nine months ended September 30, 2022[28] Cash Position - As of September 30, 2022, the company had a strong cash position of EUR 68.3 million (USD 66.8 million), up from EUR 47.2 million (USD 53.4 million) at the end of 2021[14] - Cash and cash equivalents increased to €68,329 thousand as of September 30, 2022, from €47,183 thousand at December 31, 2021[26] Assets and Liabilities - Total assets as of September 30, 2022, were €104,801 thousand, up from €77,226 thousand at December 31, 2021[26] - Total liabilities increased to €30,560 thousand as of September 30, 2022, compared to €27,172 thousand at December 31, 2021[26] Sales and Market Adoption - HIFU sales reached EUR 3.5 million (USD 3.5 million), representing an 81% growth over EUR 1.9 million (USD 2.3 million) in Q3 2021[7] - The U.S. CMS increased reimbursement for HIFU prostate ablation by more than 90%, enhancing hospital reimbursement[7] - Three new hospitals purchased Focal One systems in Q3 2022, indicating increased adoption of the technology[8] - The company is well positioned to complete the year with significant momentum due to strong commercial efforts in the U.S.[8] Research and Development - Research and development expenses for the nine months ended September 30, 2022, were €3,615 thousand, compared to €2,840 thousand in the prior year[24]

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 ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was EUR 13 million (approximately $14.5 million), a 26% increase from EUR 10.3 million (approximately $12.4 million) in Q1 2021 [5][12] - Gross profit for Q1 2022 was EUR 5.8 million, compared to EUR 4.4 million in the same period last year, with a gross profit margin of 44.3% in Q1 2022 versus 42.4% in Q1 2021 [15] - Operating loss for Q1 2022 was EUR 0.1 million, compared to an operating profit of EUR 0.2 million in Q1 2021; excluding non-cash share-based compensation, operating profit would have been EUR 2.5 million [16] Business Line Data and Key Metrics Changes - Revenue in the HIFU business for Q1 2022 was EUR 3.8 million, a 112% increase from EUR 1.8 million in Q1 2021; four Focal One Robotic HIFU units were sold in Q1 2022 compared to zero in the prior year [13] - Revenue in the LITHO business for Q1 2022 was EUR 2.2 million, down from EUR 2.9 million in Q1 2021, with one lithotripsy device sold compared to six in the previous year [14] - Revenue in the Distribution business for Q1 2022 was EUR 7 million, a 24% increase from EUR 5.6 million in Q1 2021, driven by nine ExactVu units sold compared to five in the prior year [14] Market Data and Key Metrics Changes - The US market showed strong performance with three Focal One machines sold to prestigious academic and integrated health network reference centers [8] - The sales pipeline continues to grow, with increasing interest from both academic centers and community hospitals, indicating a shift towards broader acceptance of focal therapy [20][21] Company Strategy and Development Direction - The company is focused on expanding its HIFU technology into clinical applications beyond prostate cancer, including a Phase II study for treating deep infiltrating endometriosis [6][7] - The management is optimistic about the growth potential in the US market, emphasizing the importance of building a strong sales team and infrastructure [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong start to 2022, with expectations for continued growth in capital placements and treatment volumes [18] - The company is actively engaging with CMS regarding reimbursement levels, with a guarded optimism about potential upgrades to APC level 6 [25] Other Important Information - As of March 31, 2022, the company held cash and cash equivalents of EUR 46.4 million (approximately $51.6 million), down slightly from EUR 47.2 million (approximately $53.4 million) at the end of 2021 [17] Q&A Session Summary Question: Can you speak to the growth in the dollar value of the funnel and the mix between community and academic hospitals? - The company has a strong pipeline with added interest from both academic centers and community hospitals, indicating a balanced mix [20][21] Question: What are the seasonality expectations for 2022? - Historically, Q1 is not the weakest quarter; Q3 typically sees a slowdown, with Q4 being the strongest [23] Question: Any updates on CMS conversations regarding APC level 6 eligibility? - The company remains cautiously optimistic about the potential upgrade to APC level 6, with a proposal expected in July [25] Question: How should investors think about the growth of OpEx in relation to top-line growth? - Operating expenses are expected to increase as the company builds its US team and infrastructure [28] Question: Can you comment on the time from lead to final purchase for Focal One? - The sales cycle can vary, but the company is seeing shorter cycle times as the sales team becomes more established [33] Question: What is the current trend in procedure volume? - The company continues to see sequential growth and double-digit growth quarter-over-quarter in procedure volumes [35] Question: Are there plans to explore other indications beyond endometriosis? - The company is exploring additional indications, including BPH treatment and pancreatic cancer, as part of its long-term vision [36]

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 ...