GlobeNewswire Inc | Nov 17, 2021 04:35PM EST

November 17, 2021

-- Year-to-date revenue of approximately EUR 30.1 million (USD 35.9 million) increased 14.4% year-over-year -- Q3 revenue of EUR 9.4 million (USD 11.1 million), flat with Q3 2020, reflecting lingering impact of COVID-19 on capital equipment sales -- Year-to-date US HIFU treatment volumes increased 58% over the comparable period in 2020; strong leading indicator of Focal One adoption by urologists -- Strong cash position of EUR 45.4 million (USD 52.6 million) -- Company to host a conference call tomorrow, Thursday, November 18, at 8:30 am ET

LYON, France, November 17, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (the Company), a global leader in robotic energy-based therapies, announced today unaudited financial results for the third quarter of 2021 and provided an update on strategic and operational developments.

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: We are pleased with the continued strong growth in U.S. HIFU treatment volumes, which increased 58% year-to-date over the comparable period in 2020. This is a very positive sign as it reflects the growing adoption of focal therapy by urologists. Regarding our third quarter revenue, the COVID-19 pandemic continued to weigh on hospital capital spending, and this was further impacted by several machine placements that were delayed until the early days of the fourth quarter due to logistical challenges that were exacerbated by the resurgence of the pandemic in many parts of the world. Our leading indicators are strong, we are well financed, and I believe we are well positioned to exit the year with renewed momentum.

Nine Months 2021 Results

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

Total revenue in the HIFU business for the nine months ended September 30, 2021 was EUR 5.7 million (USD 6.8 million), a decline of 18.9% as compared to EUR 7.1 million (USD 8.0 million) for the nine months ended September 30, 2020.

Total revenue in the LITHO business for the nine months ended September 30, 2021 was EUR 7.7 million (USD 9.1 million), an decrease of 7.4% from EUR 8.3 million (USD 9.4 million) for the nine months ended September 30, 2020.

Total revenue in the Distribution business for the nine months ended September 30, 2021 was EUR 16.7 million (USD 19.9 million), a 52.4% increase compared to EUR 11.0 million (USD 12.4 million) for the nine months ended September 30, 2020.

Gross profit for the nine months ended September 30, 2021 was EUR 12.2 million (USD 14.6 million), compared to EUR 11.4 million (USD 12.8 million) for the year-ago period. Gross profit margin on net sales was 40.6% for the nine months ended September 30, 2021, compared to 43.2% for the comparable period in 2020. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 14.3 million (USD 17.0 million) for the nine months ended September 30, 2021, compared to EUR 12.8 million (USD 14.5 million) for the same period in 2020.

Operating loss for the nine months ended September 30, 2021 was EUR 2.1 million (USD 2.5 million), compared to an operating loss of EUR 1.5 million (USD 1.6 million) for the nine months ended September 30, 2020.

Net loss for the nine months ended September 30, 2021 was EUR 0.7 million (USD 0.8 million), or EUR (0.02) per diluted share, as compared to a net loss of EUR 2.5 million (USD 2.8 million), or EUR (0.09) per diluted share in the year-ago period.

Third Quarter 2021 Results

Total revenue for the third quarter 2021 was EUR 9.4 million (USD 11.1 million), roughly flat with total revenue of EUR 9.4 million (USD 11.2 million) for the same period in 2020.

Total revenue in the HIFU business for the third quarter 2021 was EUR 1.9 million (USD 2.3 million), a decline of 25.6% as compared to EUR 2.6 million (USD 3.0 million) for the third quarter of 2020.

Total revenue in the LITHO business for the third quarter 2021 was EUR 2.5 million (USD 2.9 million), an increase of 3.0% from EUR 2.4 million (USD 2.9 million) for the third quarter of 2020.

Total revenue in the Distribution business for the third quarter 2021 was EUR 5.0 million (USD 5.9 million), a 13.4% increase compared to EUR 4.4 million (USD 5.2 million) for the third quarter of 2020.

Gross profit for the third quarter 2021 was EUR 3.6 million (USD 4.3 million), compared to EUR 4.0 million (USD 4.7 million) for the year-ago period. Gross profit margin on net sales was 38.4% in the third quarter of 2021, compared to 42.0% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 5.5 million (USD 6.5 million) for the third quarter of 2021, compared to EUR 4.3 million (USD 5.0 million) for the same period in 2020.

Operating loss for the third quarter of 2021 was EUR 1.9 million (USD 2.2 million), compared to an operating loss of EUR 0.3 million (USD 0.3 million) in the third quarter of 2020.

Net loss for the third quarter of 2021 was EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share in the year-ago period.

As of September 30, 2021, the company held cash and cash equivalents of EUR 45.4 million (USD $52.6 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

Conference Call

An accompanying conference call and webcast will be conducted bymanagement to review the results. The call will be held at8:30am EDT tomorrow, November 18, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & WebcastThursday, November 18, 2021 @ 8:30am Eastern TimeDomestic:877-451-6152International:201-389-0879Passcode:13724088Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1503943&tp_key=7d846a9985

Following the live call, a replay will be available on the Company's website,www.edap-tms.comunder "Investors Information."

About EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One in Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, and us.hifu-prostate.com.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as the length and severity of the COVID-19 pandemic, including its impacts across our businesses on demand for our devices and services. Factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.

Company ContactBlandine ConfortInvestor Relations / Legal AffairsEDAP TMS SA+33 4 72 15 31 50bconfort@edap-tms.com

Investor ContactJohn FrauncesLifeSci Advisors, LLC917-355-2395jfraunces@lifesciadvisors.com

EDAP TMS S.A.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Three Months Ended: Three Months Ended: Sept. 30, Sept. 30, Sept. 30, Sept. 30, 2021 2020 2021 2020 Euros Euros $US $USSales of medical 5,788 5,984 6,799 7,080 equipmentNet Sales of RPP and 1,104 1,207 1,297 1,428 LeasesSales of spare parts, 2,548 2,255 2,993 2,668 supplies and ServicesTOTAL NET SALES 9,440 9,446 11,089 11,176 Other revenues - (13) - (16) TOTAL REVENUES 9,440 9,433 11,089 11,160 Cost of sales (5,815) (5,469) (6,831) (6,470) GROSS PROFIT 3,625 3,964 4,258 4,690 Research & development (1,064) (1,090) (1,250) (1,289) expensesS, G & A expenses (4,446) (3,167) (5,222) (3,748) Total operating (5,510) (4,257) (6,472) (5,037) expensesOPERATING PROFIT (1,885) (293) (2,215) (347) (LOSS)Interest (expense) (22) (12) (25) (14) income, netCurrency exchange 1,003 (574) 1,178 (679) gains (loss), netINCOME (LOSS) BEFORETAXES AND MINORITY (904) (879) (1,062) (1,040) INTERESTIncome tax (expense) (111) (122) (130) (145) creditNET INCOME (LOSS) (1,015) (1,001) (1,192) (1,185)

Earning per share ? (0.03) (0.03) (0.04) (0.04) BasicAverage number ofshares used in 33,448,136 29,144,010 33,448,136 29,144,010 computation of EPSEarning per share ? (0.03) (0.03) (0.04) (0.04) DilutedAverage number ofshares used incomputation of EPS for 33,448,136 29,144,010 33,448,136 29,144,010 positive net income

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average three months noon buying rate of 1 Euro = 1.1747 USD, and 2020 average three months noon buying rate of 1 Euro = 1.1832 USD

EDAP TMS S.A.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands of Euros and U.S. Dollars, except per share data)

Nine Months Ended: Nine Months Ended: Sept. 30, Sept. 30, Sept. 30, Sept. 30, 2021 2020 2021 2020 Euros Euros $US $USSales of medical 19,176 16,083 22,858 18,204 equipmentNet Sales of RPP and 3,581 3,409 4,269 3,858 LeasesSales of spare parts, 7,331 6,795 8,739 7,691 supplies and ServicesTOTAL NET SALES 30,088 26,287 35,866 29,753 Other revenues 4 11 5 12 TOTAL REVENUES 30,092 26,298 35,871 29,765 Cost of sales (17,881) (14,948) (21,315) (16,919) GROSS PROFIT 12,211 11,350 14,556 12,846 Research & development (2,840) (3,058) (3,385) (3,461) expensesS, G & A expenses (11,444) (9,743) (13,642) (11,027) Total operating (14,284) (12,800) (17,027) (14,488) expensesOPERATING PROFIT (2,073) (1,451) (2,471) (1,642) (LOSS)Interest (expense) 122 (51) 145 (58) income, netCurrency exchange 1,574 (631) 1,876 (714) gains (loss), netINCOME (LOSS) BEFORETAXES AND MINORITY (378) (2,133) (450) (2,415) INTERESTIncome tax (expense) (288) (351) (343) (397) creditNET INCOME (LOSS) (665) (2,484) (793) (2,812)

Earning per share ? (0.02) (0.09) (0.02) (0.10) BasicAverage number ofshares used in 32,881,747 29,142,788 32,881,747 29,142,788 computation of EPSEarning per share ? (0.02) (0.09) (0.02) (0.10) DilutedAverage number ofshares used incomputation of EPS for 32,881,747 29,142,788 32,881,747 29,142,788 positive net income

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average nine months noon buying rate of 1 Euro = 1.1920 USD, and 2020 average nine months noon buying rate of 1 Euro = 1.1319 USD

EDAP TMS S.A.UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS (Amounts in thousands of Euros and U.S. Dollars)

September December September December 30, 31, 30, 31, 2021 2020 2021 2020 Euros Euros $US $USCash, cash equivalents and 45,411 24,696 52,572 30,201short-term treasury investmentsAccount receivables, net 10,153 12,339 11,754 15,090Inventory 8,523 7,989 9,866 9,771Other current assets 585 369 677 451TOTAL CURRENT ASSETS 64,672 45,393 74,869 55,513Property, plant and equipment, net 4,927 5,599 5,704 6,847Goodwill 2,412 2,412 2,792 2,949Other non-current assets 1,675 1,790 1,939 2,189TOTAL ASSETS 73,686 55,193 85,304 67,498Accounts payable & other accrued 8,586 10,485 9,940 12,823liabilitiesDeferred revenues, current portion 3,538 2,701 4,096 3,304Short term borrowing 1,359 2,638 1,574 3,227Other current liabilities 1,428 5,679 1,653 6,945TOTAL CURRENT LIABILITIES 14,911 21,504 17,263 26,298Obligations under operating and 1,287 1,653 1,490 2,022finance leases non-currentLong term debt, non-current 5,271 1,143 6,102 1,397Deferred revenues, non-current 698 926 808 1,132Other long term liabilities 3,478 3,720 4,026 4,549TOTAL LIABILITIES 25,646 28,945 29,689 35,399TOTAL SHAREHOLDERS?EQUITY 48,040 26,248 55,615 32,099TOTAL LIABILITIES & SHAREHOLDERS? 73,686 55,193 85,304 67,498EQUITY

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1577 USD, on September 30, 2021 and at the noon buying rate of 1 Euro = 1.2229 USD, on December 30, 2020.

EDAP TMS S.A.UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS (Amounts in thousands of Euros)





9 months 12 months 9 months 12 months ended ended ended ended Sept. 30, Dec. 31, Sept. 30 Dec. 31, 2021 2020 2021 2020 (Euros) (Euros) ($US) ($US)NET INCOME (LOSS) (655) (1,704) (793) (1,955)Adjustments to reconcile netincome (loss) to net cash 2,553 3,790 3,043 4,349generated by (used in)operating activities^(1)OPERATING CASH FLOW 1,888 2,087 2,250 2,394Increase/Decrease in operating (113) (110) (135) (126)assets and liabilitiesNET CASH GENERATED BY (USED IN) 1,774 1,977 2,115 2,269OPERATING ACTIVITIESAdditions to capitalized assetsproduced by the company and (988) (2,011) (1,178) (2,307)other capital expendituresNET CASH GENERATED BY (USED IN) (988) (2,011) (1,178) (2,307)INVESTING ACTIVITIESNET CASH GENERATED BY (USED IN) 20,384 3,201 24,299 3,673FINANCING ACTIVITIESNET EFFECT OF EXCHANGE RATECHANGES ON CASH AND CASH (455) 642 (2,865) 3,118EQUIVALENTSNET INCREASE (DECREASE) IN CASH 20,716 3,810 22,371 6,752AND CASH EQUIVALENTS

(1) including share based compensation expenses for 1,154 thousand of Euros at the end of September 2021 and 160 thousand of Euros at the end of December 2020.

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average nine months noon buying rate of 1 Euro = 1.1920 USD, and 2020 average twelve months noon buying rate of 1 Euro = 1.1474USD

EDAP TMS S.A.UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISIONNINE MONTHS ENDED SEPTEMBER 30, 2021(Amounts in thousands of Euros)

HIFU ESWL Distribution Reconciling Total After Division Division Division Items Consolidation Sales of 1,844 2,675 14,657 19,176goodsSales ofRPPs & 2,617 767 197 3,581 LeasesSales ofspare parts 1,251 4,226 1,854 7,331 & servicesTOTAL NETSALES 5,713 7,667 16,708 30,088

Otherrevenues 4 0 0 4

TOTAL 5,717 7,667 16,708 30,092 REVENUESGROSS PROFIT 37.6(% of Total 2,150 % 3,526 46.0% 6,536 39.1% 12,211 40.6%Revenues) (652) (232) (2,840) Research & (1,955)DevelopmentTotal SG&Aplus (3,463) (2,289) (4,237) (1,455) (11,444) depreciation

OPERATING PROFIT (3,269) 585 2,067 (1,455) (2,073)(LOSS)



Attachment

-- 2021-11-17 -- EDAP 3Q 2021 approved