GlobeNewswire Inc | Aug 25, 2021 04:35PM EDT

August 25, 2021

-- Total revenue for the first half 2021 of EUR 20.7 million (USD $24.8 million) increased 22.5%over the same period of the prior year -- Net income was EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share, for the first half of 2021 -- Cash balance of EUR 45 million (USD $53.3 million) as of June 30, 2021 -- Second quarter U.S. HIFU treatment volumes increased 79% over the comparable period in 2020; strong leading indicator of Focal One adoption -- CMS Advisory Panel on Hospital Outpatient Payment (HOP panel), at its summer meeting, unanimously recommended increasing reimbursement for HIFU prostate ablation to APC Level 6 in 2022 from Level 5 currently -- Company to host a conference call tomorrow, August 26, at 8:30 am ET

LYON, France, August 25, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (the Company), a global leader in robotic energy-based therapies, announced today unaudited financial results for the second quarter of 2021 and provided an update on strategic and operational developments.

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: We were very pleased during the second quarter to see continued strong growth in U.S. Focal One treatment volumes, a metric that we believe reflects accelerating HIFU adoption as a prostate cancer treatment alternative. While the ongoing COVID pandemic continues to weigh on hospital capital spending, we nonetheless continued to build a robust pipeline of Focal One and ExactVu pipeline opportunities, and we are optimistic that we will close additional high-profile sales this year."

On the reimbursement front, just a few days ago, the CMS HOP panel voted unanimously in favor of increasing reimbursement for HIFU prostate ablation to APC Level 6 next year from Level 5 currently. Even if the HOP panel has only an advisory role to CMS, we believe this is a strong signal and further recognition of the value of HIFU in this indication. We hope this will be taken into account by CMS when building the final rule, which will be published in December of this year. If this is the case, reimbursement for Focal One HIFU would increase from an average of approximately $4,500 per procedure this year to an average of approximately $8,500 per procedure in 2022. This increase, if implemented, could be a significant catalyst to accelerating Focal One sales in 2022 and beyond."

Importantly, our U.S. expansion plans, led by new U.S. subsidiary CEO Ryan Rhodes, are progressing and we are well financed with more than $53 million on our balance sheet. I believe we are poised for a strong back half of the year and accelerating HIFU momentum heading into 2022.

For the first six months 2021 Results

Total revenue for the first half of 2021 was EUR 20.7 million (USD 24.8 million), an increase of 22.5% compared to total revenue of EUR 16.9 million (USD 18.7 million) for the same period in 2020.

Total revenue in the HIFU business for the first six months of 2021 was EUR 3.8 million (USD 4.6 million), a decline of 15.1% as compared to EUR 4.5 million (USD 4.9 million) for the first six months of 2020.

Total revenue in the LITHO business for the first six months of 2021 was EUR 5.2 million (USD 6.2 million), a decline of 11.8% from EUR 5.9 million (USD 6.5 million) for the first six months of 2020.

Total revenue in the Distribution business for the first six months of 2021 was EUR 11.7 million (USD 14.0 million), a 79.0% increase compared to EUR 6.5 million (USD 7.2 million) for the first six months of 2020.

Gross profit for the first six months of 2021 was EUR 8.6 million (USD 10.3 million), compared to EUR 7.4 million (USD 8.2 million) for the year-ago period. Gross profit margin on net sales was 41.6% in the first six months of 2021, compared to 43.9% 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 8.8 million (USD 10.5 million) for the first six months of 2021, compared to EUR 8.5 million (USD 9.5 million) for the same period in 2020.

Operating loss for the first six months of 2021 was EUR 0.2 million (USD 0.2 million), compared to an operating loss of EUR 1.2 million (USD 1.3 million) for the same period in 2020.

Net income for the first six months of 2021 was EUR 0.4 million (USD0.4 million), or EUR 0.01 per diluted share, as compared to a net loss of EUR 1.5 million (USD 1.6 million), or EUR (0.05) per diluted share in the year-ago period.

As of June 30, 2021, the company held cash and cash equivalents of EUR 45.0million (USD 53.3 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

Second Quarter 2021 Results

Total revenue for the second quarter 2021 was EUR 10.4 million (USD 12.4 million), an increase of 11.8% compared to total revenue of EUR 9.3 million (USD 10.3 million) for the same period in 2020.

Total revenue in the HIFU business for the second quarter 2021 was EUR 2.0 million (USD 2.4 million), a decline of 21.8% as compared to EUR 2.6 million (USD 2.8 million) for the second quarter of 2020.

Total revenue in the LITHO business for the second quarter 2021 was EUR 2.3 million (USD 2.7 million), a decline of 22.6% from EUR 2.9 million (USD 3.2million) for the second quarter of 2020.

Total revenue in the Distribution business for the second quarter 2021 was EUR 6.1 million (USD 7.3 million), a 61.6% increase compared to EUR 3.8 million (USD 4.2 million) for the second quarter of 2020.

Gross profit for the second quarter 2021 was EUR 4.2 million (USD 5.1 million), compared to EUR 4.3 million (USD 4.8 million) for the year-ago period. Gross profit margin on net sales was 40.7% in the second quarter of 2021, compared to 46.8% in the year-ago period.

Operating expenses were EUR 4.6 million (USD 5.6 million) for the second quarter of 2021, compared to EUR 4.0 million (USD 4.5 million) for the same period in 2020.

Operating loss for the second quarter of 2021 was EUR 0.4 million (USD 0.5 million), compared to an operating profit of EUR 0.3 million (USD 0.3 million) in the second quarter of 2020.

Net loss for the second quarter of 2021 was EUR 0.4 million (USD 0.5 million), or EUR (0.01) per diluted share, as compared to a net loss of EUR 0.2 million (USD 0.2 million), or EUR (0.01) per diluted share in the year-ago period.

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, August 26, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & WebcastThursday, August 26, 2021 @ 8:30am Eastern Time

Domestic: 877-451-6152International: 201-389-0879Passcode: 13721942Webcast: http://public.viavid.com/index.php?id=145982

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 TMSdevelops, 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 TMSintroduced the Focal One inEuropeand 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 ContactJeremy FefferLifeSci Advisors, LLC212-915-2568 jeremy@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:

June. 30, June. 30, June. 30, June. 30, 2021 2020 2021 2020 Euros Euros $US $USSales of medical 6,696 5,975 8,051 6,628 equipmentNet Sales of RPP and 1,265 947 1,521 1,050 LeasesSales of spare parts, 2,387 2,311 2,870 2,564 supplies and ServicesTOTAL NET SALES 10,349 9,233 12,443 10,242 Other revenues 1 23 2 25 TOTAL REVENUES 10,350 9,255 12,445 10,267 Cost of sales (6,134) (4,931) (7,376) (5,470) GROSS PROFIT 4,216 4,324 5,069 4,797 Research & development (925) (926) (1,112) (1,027) expensesS, G & A expenses (3,718) (3,096) (4,470) (3,434) Total operating (4,642) (4,022) (5,582) (4,461) expensesOPERATING PROFIT (427) 303 (513) 336 (LOSS)Interest (expense) (20) (19) (25) (21) income, netCurrency exchange 82 (346) 98 (384) gains (loss), netOther income, net - (1) - (1) INCOME (LOSS) BEFORETAXES AND MINORITY (365) (63) (439) (70) INTERESTIncome tax (expense) (58) (112) (70) (124) creditNET INCOME (LOSS) (424) (175) (509) (194)

Earning per share ? (0.01) (0.01) (0.02) (0.01) BasicAverage number ofshares used in 32,220,414 29,141,566 32,220,414 29,141,566 computation of EPSEarning per share ? (0.01) (0.01) (0.02) (0.01) DilutedAverage number ofshares used in 29,141,566 29,141,566computation of EPS for 32,220,414 32,220,414 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 = 1.2024 USD, and 2020 average three months noon buying rate of 1 Euro = 1.1093 USD

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

Six Months Ended: Six Months Ended:

June. 30, June. 30, June. 30, June. 30, 2021 2020 2021 2020 Euros Euros $US $USSales of medical 13,387 10,099 16,075 11,173 equipmentNet Sales of RPP and 2,477 2,202 2,975 2,436 LeasesSales of spare parts, 4,784 4,539 5,744 5,022 supplies and ServicesTOTAL NET SALES 20,648 16,841 24,794 18,631 Other revenues 4 24 5 27 TOTAL REVENUES 20,653 16,865 24,799 18,658 Cost of sales (12,066) (9,479) (14,488) (10,487) GROSS PROFIT 8,587 7,386 10,311 8,171 Research & development (1,776) (1,968) (2,132) (2,177) expensesS, G & A expenses (6,998) (6,575) (8,403) (7,274) Total operating (8,774) (8,543) (10,536) (9,452) expensesOPERATING PROFIT (188) (1,157) (225) (1,280) (LOSS)Interest (expense) 143 (39) 172 (43) income, netCurrency exchange 571 (57) 685 (63) gains (loss), netOther income, net - 0 - (1) INCOME (LOSS) BEFORETAXES AND MINORITY 527 (1,254) 632 (1,388) INTERESTIncome tax (expense) (177) (228) (213) (252) creditNET INCOME (LOSS) 350 (1,483) 420 (1,640)

Earning per share ? 0.01 (0.05) 0.01 (0.06) BasicAverage number ofshares used in 30,705,356 29,141,566 30,705,356 29,141,566 computation of EPSEarning per share ? 0.01 (0.05) 0.01 (0.06) DilutedAverage number ofshares used incomputation of EPS for 31,994,402 29,141,566 31,994,402 29,141,566 positive net income

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average six months noon buying rate of 1 Euro = 1.2008 USD, and 2020 average six months noon buying rate of 1 Euro = 1.1063 USD

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

June 30, Dec. June Dec. 2021 31, 30, 31, Euros 2020 2021 2020 Euros $US $USCash, cash equivalents and short-term 44,961 24,696 53,272 30,201treasury investmentsAccount receivables, net 11,183 12,339 13,249 15,090Inventory 8,610 7,989 10,202 9,771Other current assets 618 369 732 451TOTAL CURRENT ASSETS 65,372 45,393 77,455 55,513Property, plant and equipment, net 5,135 5,599 6,084 6,847Goodwill 2,412 2,412 2,858 2,949Other non-current assets 1,704 1,790 2,019 2,189TOTAL ASSETS 74,622 55,193 88,415 67,498Accounts payable & other accrued 9,297 10,256 11,016 12,543liabilitiesDeferred revenues, current portion 3,264 2,701 3,867 3,304Short term borrowing 1,447 2,638 1,714 3,227Other current liabilities 1,340 5,679 1,588 6,945TOTAL CURRENT LIABILITIES 15,348 21,275 18,185 26,018Obligations under operating and finance 1,415 1,653 1,677 2,022leases non-currentLong term debt, non-current 5,215 1,143 6,179 1,397Deferred revenues, non-current 826 926 979 1,132Other long term liabilities 3,628 3,949 4,298 4,829TOTAL LIABILITIES 26,432 28,945 31,317 35,399TOTAL SHAREHOLDERS?EQUITY 48,191 26,248 57,098 32,099TOTAL LIABILITIES & SHAREHOLDERS? EQUITY 74,622 55,193 88,415 67,498

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1848 USD on June 30, 2021 and at the noon buying rate of 1 Euro = 1.2229 USD on December 31, 2020

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

6-months 12-months 6-months 12-months ended ended ended ended June 30, Dec. 31, June 30, Dec. 31 2021 2020 2021 2020 Euros Euros $US $USNET INCOME (LOSS) 350 (1,704) 420 (1,955)Adjustments to reconcile netincome (loss) to net cash 976 3,790 1,172 4,349generated by (used in)operating activities^(1^)OPERATING CASH FLOW 1,326 2,087 1,592 2,394Increase/Decrease in operating (585) (110) (702) (126)assets and liabilitiesNET CASH GENERATED BY (USED IN) 741 1,977 890 2,269OPERATING ACTIVITIESShort term investments^(2) - - - -Additions to capitalized assetsproduced by the company and (644) (2,011) (773) (2,307)other capital expendituresNET CASH GENERATED BY (USED IN) (644) (2,011) (773) (2,307)INVESTING ACTIVITIESNET CASH GENERATED BY (USED IN) 20,368 3,201 24,457 3,673FINANCING ACTIVITIESNET EFFECT OF EXCHANGE RATECHANGES ON CASH AND CASH (199) 642 (1,503) 3,118EQUIVALENTSNET INCREASE (DECREASE) IN CASH 20,266 3,810 23,071 6,752AND CASH EQUIVALENTS

(1) including Share based compensation expenses for 180 thousandof Euros at the end of June 2021, and 160 thousand of Euros at the end of December 2020

(2) Short term investments are comprised of money market funds

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average six months noon buying rate of 1 Euro = 1.2008 USD and at the 2020 average twelve months noon buying rate of 1 Euro = 1.1474 USD

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

HIFU ESWL Distribution Reconciling Total After Division Division Division Items Consolidation Sales of 1,151 1,881 10,356 13,387goodsSales ofRPPs & 1,798 540 139 2,477 LeasesSales ofspare parts 846 2,755 1,182 4,784 & servicesTOTAL NETSALES 3,795 5,176 11,677 20,648

Otherrevenues 4 0 0 4

TOTAL 3,799 5,176 11,677 20,653 REVENUESGROSS PROFIT(% of Total 1,501 39.5% 2,472 47.8% 4,614 39.5% 8,587 41.6%Revenues) (418) (150) (1,776) Research & (1,208)DevelopmentTotal SG&Aplus (1,946) (1,453) (2,689) (911) (6,998) depreciation

OPERATING PROFIT (1,652) 601 1,775 (911) (188)(LOSS)

Attachment

-- 2021-08-25 -- EDAP Q2 2021 press release - approved