GlobeNewswire Inc | May 11, 2021 04:30PM EDT

May 11, 2021

-- Generated record first quarter revenue of EUR 10.3 million (USD 12.4 million), an increase of 35.4% year-over-year -- Increased gross margin year-over-year to 42.4%, contributing to a profitable quarter -- Raised gross proceeds of approximately $28 million through an underwritten offering of American Depository Shares (ADSs) -- Strong cash position of EUR 24.4 million (USD 28.6 million) as of March 31, 2021, excluding $28 million of gross proceeds raised in April -- Company to host a conference call tomorrow, May 12, at 8:30 am ET

LYON, France, May 11, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (the Company), a global leader in robotic energy-based therapies, announced today unaudited financial results for the first quarter of 2021 and provided an update on strategic and operational developments.

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: We are thrilled to have completed a successful offering in April which, added to our existing strong cash position, provides funding to achieve potentially value-creating milestones across all aspects of our business. We are acutely focused on driving accelerating growth in the US by building market access and coverage now that our Category 1 CPT code is in place. We also continue to advance our Phase 2 endometriosis program and have now opened a second trial site in France where we commenced patient treatments last week.

While we continue to experience some effect of COVID-19 on our operations, we are pleased with the global performance of our business as compared to the first quarter of last year. We grew revenue by 35.4%, expanded our gross margin to 42.4%, and generated a profitable quarter for the company. We also saw continued growth in our Focal One and HIFU treatments in the US, reflecting increasing awareness and adoption of our next generation HIFU technology.

In summary, with our strong balance sheet and US growth initiatives continuing to gain traction, I believe we are well positioned to drive growing adoption of HIFU for the management of prostate cancer in 2021, Mr. Oczachowski concluded.

First Quarter 2021 Results

Total revenue for the first quarter 2021 was EUR 10.3 million (USD 12.4 million), an increase of 35.4% compared to total revenue of EUR 7.6 million (USD 8.4 million) for the same period in 2020.

Total revenue in the HIFU business for the first quarter 2021 was EUR 1.8 million (USD 2.2 million), a decline of 6.2% as compared to EUR 1.9 million (USD 2.1 million) for the first quarter of 2020.

Total revenue in the LITHO business for the first quarter 2021 was EUR 2.9 million (USD 3.5 million), roughly flat with EUR 2.9 million (USD 3.2 million) for the first quarter of 2020.

Total revenue in the Distribution business for the first quarter 2021 was EUR 5.6 million (USD 6.7 million), a 102.5 % increase compared to EUR 2.8 million (USD 3.1 million) for the first quarter of 2020.

Gross profit for the first quarter 2021 was EUR 4.4 million (USD 5.2 million), compared to EUR 3.1 million (USD 3.4 million) for the year-ago period. Gross profit margin on net sales was 42.4% in the first quarter of 2021, compared to 40.2% in the year-ago period. The increase in gross profit year-over-year was due to higher sales effect on fixed costs.

Operating expenses were EUR 4.1 million (USD 5.0 million) for the first quarter of 2021, compared to EUR 4.5 million (USD 5.0 million) for the same period in 2020.

Operating profit for the first quarter of 2021 was EUR 0.2 million (USD 0.3 million), compared to an operating loss of EUR 1.5 million (USD 1.6 million) in the first quarter of 2020.

Net income for the first quarter of 2021 was EUR 0.8 million (USD 0.9 million), or EUR 0.03 per diluted share, as compared to a net loss of EUR 1.3 million (USD 1.4 million), or EUR (0.04) per diluted share in the year-ago period.

As of March 31, 2021, the company held cash and cash equivalents of EUR 24.4 million (USD 28.6 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020. Subsequent to the end of the first quarter, the completed an underwritten public offering of its American Depository Shares that yielded gross proceeds of approximately $28 million.

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, May 12, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & WebcastWednesday, May 12, 2021 @ 8:30am Eastern TimeDomestic: 877-451-6152International: 201-389-0879Passcode: 13718852Webcast: http://public.viavid.com/index.php?id=144433

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:

Mar. 31, Mar. 31, Mar. 31, Mar. 31, 2021 2020 2021 2020 Euros Euros $US $USSales of medical 6,691 4,125 8,023 4,551 equipmentNet Sales of RPP and 1,212 1,255 1,453 1,385 LeasesSales of spare parts, 2,396 2,228 2,873 2,458 supplies and ServicesTOTAL NET SALES 10,299 7,608 12,349 8,394 Other revenues 3 2 3 2 TOTAL REVENUES 10,302 7,610 12,353 8,395 Cost of sales (5,932) (4,548) (7,112) (5,018) GROSS PROFIT 4,371 3,062 5,241 3,378 Research & development (851) (1,042) (1,020) (1,150) expensesS, G & A expenses (3,281) (3,480) (3,934) (3,839) Total operating (4,132) (4,522) (4,954) (4,989) expensesOPERATING PROFIT 239 (1,460) 287 (1,611) (LOSS)Interest (expense) 164 (20) 196 (22) income, netCurrency exchange 489 289 587 319 gains (loss), netINCOME (LOSS) BEFORETAXES AND MINORITY 892 (1,191) 1,070 (1,315) INTERESTIncome tax (expense) (119) (116) (143) (128) creditNET INCOME (LOSS) 773 (1,308) 927 (1,443)

Earning per share ? 0.03 (0.04) 0.03 (0.05) BasicAverage number ofshares used in 29,189,955 29,141,566 29,189,955 29,141,566 computation of EPSEarning per share ? 0.03 (0.04) 0.03 (0.05) DilutedAverage number ofshares used incomputation of EPS for 30,352,216 29,141,566 30,352,216 29,141,566 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 = 1.1990 USD, and 2020 average three months noon buying rate of 1 Euro = 1.1033 USD

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

Mar. 31, Dec. Mar. Dec. 2021 31, 31, 31, Euros 2020 2021 2020 Euros $US $USCash, cash equivalents and short-term 24,382 24,696 28,630 30,201treasury investmentsAccount receivables, net 10,264 12,339 12,053 15,090Inventory 8,348 7,989 9,802 9,771Other current assets 564 369 662 451TOTAL CURRENT ASSETS 43,557 45,393 51,147 55,513Property, plant and equipment, net 5,570 5,599 6,540 6,847Goodwill 2,412 2,412 2,832 2,949Other non-current assets 1,761 1,790 2,068 2,189TOTAL ASSETS 53,299 55,193 62,587 67,498Accounts payable & other accrued 9,374 10,485 11,008 12,823liabilitiesDeferred revenues, current portion 3,011 2,701 3,535 3,304Short term borrowing 1,391 2,638 1,634 3,227Other current liabilities 5,492 5,679 6,449 6,945TOTAL CURRENT LIABILITIES 19,268 21,504 22,626 26,298Obligations under operating and finance 1,679 1,653 1,972 2,022leases non-currentLong term debt, non-current 1,157 1,143 1,359 1,397Deferred revenues, non-current 837 926 983 1,132Other long term liabilities 3,502 3,720 4,112 4,549TOTAL LIABILITIES 26,443 28,945 31,051 35,399TOTAL SHAREHOLDERS?EQUITY 26,856 26,248 31,536 32,099TOTAL LIABILITIES & SHAREHOLDERS? EQUITY 53,299 55,193 62,587 67,498

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1743 USD on March 31, 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)

3-months 3-months 12-months ended 12-months ended ended Mar. 31, ended Mar. 31, Dec. 31 2021 Dec. 31, 2021 2020 Euros 2020 $US $US EurosNET INCOME (LOSS) 773 (1,704) 927 (1,955)Adjustments to reconcile netincome (loss) to net cash 167 3,790 201 4,349generated by (used in)operating activities^(1^)OPERATING CASH FLOW 940 2,087 1,128 2,394Increase/Decrease in operating 539 (110) 646 (126)assets and liabilitiesNET CASH GENERATED BY (USED IN) 1,479 1,977 1,774 2,269OPERATING ACTIVITIESShort term investments^(2) - - - -Additions to capitalized assetsproduced by the company and (294) (2,011) (353) (2,307)other capital expendituresNET CASH GENERATED BY (USED IN) (294) (2,011) (353) (2,307)INVESTING ACTIVITIESNET CASH GENERATED BY (USED IN) (1,230) 3,201 (1,475) 3,673FINANCING ACTIVITIESNET EFFECT OF EXCHANGE RATECHANGES ON CASH AND CASH (269) 642 (1,517) 3,118EQUIVALENTSNET INCREASE (DECREASE) IN CASH (314) 3,810 (1,571) 6,752AND CASH EQUIVALENTS

(1) including Share based compensation expenses for 28 thousands of Euros at the end of March 2021, and 160 thousands 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 three months noon buying rate of 1 Euro = 1.1990 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 DIVISIONTHREE MONTHS ENDED MARCH 31, 2021(Amounts in thousands of Euros)

HIFU ESWL Distribution Reconciling Total After Division Division Division Items Consolidation Sales of 487 1,212 4,992 6,691goodsSales of RPPs 888 262 62 1,212 & LeasesSales ofspare parts & 427 1,420 549 2,396 servicesTOTAL NETSALES 1,802 2,895 5,603 10,299

Otherrevenues 3 0 0 3

TOTAL 1,805 2,895 5,603 10,302 REVENUESGROSS PROFIT 38.2(% of Total 690 % 1,422 49.1% 2,259 40.3% 4,371 42.4%Revenues) (196) (73) (851) Research & (582)DevelopmentTotal SG&Aplus (918) (657) (1,344) (362) (3,281) depreciation OPERATING (810) 570 841 (362) 239PROFIT (LOSS)

















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-- 2021-05-11 -- EDAP Q1 2021 press release FINAL