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Lyon, France, November 17, 2021-EDAP TMS SA (NASDAQ: EDAP) (the "Company"), a global leader in robotic energy therapy, today announced unaudited financial results for the third quarter of 2021 It also provides the latest information on strategic and operational development. 

Marc Oczachowski, Chairman and CEO of EDAP, said: “We are pleased with the continued strong growth in the number of HIFU treatments in the United States, which has increased by 58% year-to-date compared to the same period in 2020. This is a very positive sign because it reflects Urologists are increasingly adopting topical treatments. Regarding our third quarter revenue, the COVID-19 pandemic continues to put pressure on hospital capital expenditures, which was further affected by the placement of several machines, which were placed due to logistics Challenges and postponed pandemics in many parts of the world at the beginning of the fourth quarter. Our leading indicators are strong and funds are sufficient. I believe we are ready to exit this year with a new momentum."

Total revenue for the nine months ended September 30, 2021 was 30.1 million euros (35.9 million U.S. dollars), an increase of 14.4% from the total revenue of 26.3 million (29.8 million U.S. dollars) for the same period in 2020.

Total revenue from HIFU business for the nine months ended September 30, 2021 was 5.7 million euros (6.8 million US dollars), a decrease of 18.9% from the 7.1 million euros (8 million US dollars) for the nine months ended September 30, 2020 .

The total revenue of the LITHO business for the nine months ended September 30, 2021 was 7.7 million euros (9.1 million U.S. dollars), a decrease of 7.4% from the 8.3 million euros (9.4 million U.S. dollars) for the nine months ended September 30, 2020 .

For the nine months ended September 30, 2021, the total revenue of the distribution business was 16.7 million euros (19.9 million U.S. dollars), an increase of 52.4 from the 11 million euros (12.4 million U.S. dollars) for the nine months ended September 30, 2020 %.

Gross profit for the nine months ended September 30, 2021 was 12.2 million euros (14.6 million U.S. dollars), compared with 11.4 million euros (12.8 million U.S. dollars) in the same period last year. The gross profit margin for net sales for the nine months ended September 30, 2021 was 40.6%, compared to 43.2% for the 2020 comparable period. Especially in the HIFU business.

Operating expenses for the nine months ended September 30, 2021 were 14.3 million euros ($17 million), compared to 12.8 million euros ($14.5 million) for the same period in 2020.

The operating loss for the nine months ended September 30, 2021 was 2.1 million euros (2.5 million U.S. dollars), while the operating loss for the nine months ended September 30, 2020 was 1.5 million euros (1.6 million U.S. dollars).

The net loss for the nine months ended September 30, 2021 was EUR 700,000 (USD 0.8 million) or 0.02 EUR (EUR 0.02) per diluted share, while the net loss was EUR 2.5 million (USD 2.8 million) or 0.09 Euro (0.09 Euro)) Diluted earnings per share in the same period last year.

Total revenue for the third quarter of 2021 was 9.4 million euros (11.1 million U.S. dollars), roughly the same as the total revenue of 9.4 million euros (11.2 million U.S. dollars) for the same period in 2020.

The total revenue of the HIFU business in the third quarter of 2021 was 1.9 million euros (2.3 million U.S. dollars), a decrease of 25.6% compared with the 2.6 million euros (3 million U.S. dollars) in the third quarter of 2020.

The total revenue of the LITHO business in the third quarter of 2021 was 2.5 million euros (2.9 million US dollars), an increase of 3.0% from the 2.4 million euros (2.9 million US dollars) in the third quarter of 2020.

The total revenue of the distribution business in the third quarter of 2021 was 5 million euros (5.9 million U.S. dollars), an increase of 13.4% compared to the 4.4 million euros (5.2 million U.S. dollars) in the third quarter of 2020.

Gross profit for the third quarter of 2021 was 3.6 million euros (4.3 million U.S. dollars), compared with 4 million euros (4.7 million U.S. dollars) in the same period last year. The gross profit margin of net sales in the third quarter of 2021 was 38.4%, compared with 42.0% in the same period last year. The year-on-year decrease in gross profit was due to the reduced sales effect of fixed costs, especially for the HIFU business.

Operating expenses for the third quarter of 2021 were 5.5 million euros (6.5 million U.S. dollars), compared to 4.3 million euros (5 million U.S. dollars) for the same period in 2020.

The operating loss in the third quarter of 2021 was 1.9 million euros ($2.2 million), while the operating loss in the third quarter of 2020 was 300,000 euros ($300,000).

The net loss for the third quarter of 2021 was EUR 1 million (USD 1.2 million) or diluted earnings per share (EUR 0.03), compared to a net loss of EUR 1 million (USD 1.2 million) or diluted earnings per share (0.03 EUR). Euro) the share of the same period last year.

As of September 30, 2021, the company held 45.4 million euros (52.6 million U.S. dollars) in cash and cash equivalents, compared with 24.7 million euros (30.2 million U.S. dollars) as of December 31, 2020.

The management will conduct an accompanying conference call and webcast to review the results. The conference call will be held tomorrow (November 18, 2021) at 8:30 AM Eastern Time. For conference call dial-in information and webcast registration information, please refer to the following information.

Conference call and webcast Thursday, November 18, 2021, 8:30 am Eastern Time Domestic: 877-451-6152 International: 201-389-0879 Passcode: 13724088 Webcast: https://viavid.webcasts.com/starthere.jsp39key439t8p39key43708p54a37d8p

After the conference call, a replay will be provided under "Investor Information" on the company's website www.edap-tms.com.

As a recognized leader in the global therapeutic ultrasound market, EDAP TMS uses ultrasound technology to develop, manufacture, promote and distribute minimally invasive medical devices for various pathologies worldwide. By combining the latest technologies in imaging and treatment methods in its complete line of robotic HIFU equipment, EDAP TMS has launched Focal One® in Europe and the United States to meet all requirements for ideal prostate tissue ablation. With the addition of ExactVu™ micro ultrasound equipment, EDAP TMS is now the only company that provides a complete solution from diagnosis to local treatment of prostate cancer. EDAP TMS also manufactures and distributes other medical equipment, including Sonolith® i-move lithotripters and lasers, used to treat urinary stones using extracorporeal shock wave lithotripsy (ESWL). For more information about the company, please visit http://www.edap-tms.com and us.hifu-prostate.com.

In addition to historical information, this press release also contains forward-looking statements. Such statements are based on management’s current expectations and are subject to many risks and uncertainties, including matters that we do not yet understand or that we currently consider to be unimportant, and there is no guarantee that expected events will occur or that the set goals will actually come out. Will come true. Important factors that may cause actual results to differ materially from the expected results in the forward-looking statements include, among them, the clinical condition and market acceptance of our HIFU devices and the continued market potential of our gravel and distribution divisions, as well as the COVID-19 pandemic The duration and severity, including its impact on our business’ demand for our equipment and services. Factors that may cause such discrepancies may also include but are not limited to the factors described in the company’s filings with the U.S. Securities and Exchange Commission, especially the "Warning Statement of Forward-Looking Information" and "Risk Factors" in the company's annual report 20- F table.

Company Contact Information Blandine Confort Investor Relations/Legal Affairs EDAP TMS SA 33 4 72 15 31 50bconfort@edap-tms.com

Investor Contact Information John FrauncesLifeSci Advisors, LLC917-355-2395jfraunces@lifesciadvisors.com

EDAP TMS SAUNAUDITED Condensed Consolidated Operating Statement (Amounts are in thousands of Euros and U.S. dollars, except for per share data)

Note: For the convenience of readers, the average three-month buying price at noon in 2021 is 1 Euro = 1.1747 USD, and the average three-month buying price at noon in 2020 is 1 Euro = 1.1832 USD converted into USD

EDAP TMS SAUNAUDITED Condensed Consolidated Operating Statement (Amounts are in thousands of Euros and U.S. dollars, except for per share data)

Note: For the convenience of readers, the 9-month average buying price at noon in 2021 1 Euro = 1.1920 USD and the 9-month average buying price at noon in 2020 1 Euro = 1.1319 USD are converted into USD 

EDAP TMS SAUNAUDITED CONSOLIDATED CONSOLIDATED BALANCE SheetS HIGHLIGHTS (amount in thousands of euros and US dollars)

Note: For the convenience of readers, the buying price of 1 Euro = 1.1577 USD at noon on September 30, 2021 and the buying price of 1 Euro = 1.2229 USD at noon on December 30, 2020 are converted into USD.

EDAP TMS SAUNAUDITED consolidated cash flow statement (amount in thousands of euros)

(1) Including 1.154 million euros at the end of September 2021 and 160,000 euros at the end of December 2020 for share compensation expenses.

Note: For the convenience of readers, the average buying price of 1 Euro at noon in 2021 = 1.1920 USD and the 12-month average buying price of 1 Euro at noon = 1.1474 USD are converted into USD for the convenience of readers. 

EDAP TMS audited concise operating statement (amount in thousands of euros) by the 9th month ending September 30, 2021

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