GlobeNewswire Inc | Nov 18, 2020 04:35PM EST

November 18, 2020



-- Generated strongest total revenue quarter of 2020 -- Reported growth in HIFU procedure revenues year-over-year notwithstanding ongoing COVID-19 pandemic -- Completed sales to renowned healthcare institutions Mount Sinai Health System in New York and Keck Medical Center at the University of Southern California -- Announced first patients treated in Phase 2 clinical trial assessing Focal One as a potential treatment for deep rectal endometriosis -- Increased strong cash position to EUR 19.9 million (USD 23.4 million) as of September 30, 2020 -- Company to host a conference call tomorrow, November 19th, at 8:30 am ET

LYON, France, November 18, 2020 -- EDAP TMS SA (Nasdaq: EDAP) (the Company), the global leader in robotic energy based therapies, announced today financial results for the third quarter of 2020 and provided an update on strategic and operational developments.

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: The third quarter of 2020 was our strongest of the year thus far, a clear signal that we are successfully navigating through the challenges posed by the ongoing COVID-19 pandemic. We closed several notable transactions during the quarter, including a bundled Focal One-ExactVu sale to Mount Sinai Health System in New York, and a Focal One sale to Keck Medical Center of University of Southern California, an early adopter of our first generation HIFU technology, Ablatherm. At the same time, we continued to grow our sales pipeline, both in the U.S. and internationally.

Also, during the quarter, we received regulatory approval to initiate a Phase 2 study assessing Focal One as a potential treatment for deep rectal endometriosis and we initiated patient treatments quickly thereafter. Endometriosis represents an important expansion of our development pipeline as we work to maximize the clinical utility of HIFU across new indications beyond prostate.

We ended the quarter with a strong cash position of $23.4 million, sufficient to continue to execute on our Focal One-ExactVu commercial plan while advancing HIFU in endometriosis and other soft tissue indications where we believe this non-invasive technology can be beneficial.

With COVID cases again rising in many parts of the world, including most of the US, we are carefully monitoring the effect on our operations during the fourth quarter. While we are seeing some impact on procedure volumes as hospitals continue to focus on the pandemic, we are nonetheless optimistic that we will be able to announce additional sales by the end of the year, Mr. Oczachowski concluded.

Third Quarter 2020 Results

Total revenue for the third quarter 2020 was EUR 9.4 million (USD 11.2 million), a decrease of 8.5% compared to total revenue of EUR 10.3 million (USD 11.3 million) for the same period in 2019. Third quarter 2020 revenue reflects the impact of the ongoing COVID-19 pandemic on equipment sales.

Total revenue in the HIFU business for the third quarter 2020 was EUR 2.6 million (USD 3.0 million), a 7.9% decrease compared to EUR 2.8 million (USD 3.1 million) for the third quarter of 2019.

Total revenue in the LITHO business for the third quarter 2020 was EUR 2.4 million (USD 2.9 million), a 27.6% decrease compared to EUR 3.3 million (USD 3.7 million) for the third quarter of 2019

Total revenue in the Distribution business for the third quarter 2020 was EUR 4.4 million (USD 5.2 million), a 6.4% increase compared to EUR 4.2 million (USD 4.6 million) for the third quarter of 2019.

Gross profit for the third quarter 2020 was EUR 4.0 million (USD 4.7 million), compared to EUR 4.7 million (USD 5.1 million) for the year-ago period. Gross profit margin on net sales was 42.0% in the third quarter of 2020, compared to 45.3% in the year-ago period. The decline in gross profit year-over-year was due to in part to lower sales in HIFU business as compared to the year-ago period driven primary by COVID-19.

Operating expenses were EUR 4.3 million (USD 5.0 million) for the third quarter of 2020, compared to EUR 4.4 million (USD 4.9 million) for the same period in 2019.

Operating loss for the third quarter of 2020 was EUR 0.3 million (USD 0.3 million), compared to an operating profit of EUR 0.3 million (USD 0.3 million) in the third quarter of 2019.

Net loss for the third of 2020 was EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share, as compared to net income of EUR 0.8 million (USD 0.9 million), or EUR 0.03 per diluted share in the year-ago period.

For the first nine months 2020 Results

Total revenue for the first nine months of 2020 was EUR 26.3 million (USD 29.8 million), a decrease of 20.1% compared to total revenue of EUR 32.9 million (USD 36.9 million) for the same period in 2019. As mentioned, year-to-date revenue reflects the impact of the ongoing COVID-19 pandemic on the companys activities.

Total revenue in the HIFU business for the first nine months of 2020 was EUR 7.1 million (USD 8.0 million), a 37.2% decrease compared to EUR 11.2 million (USD 12.6 million) for the first nine months of 2019.

Total revenue in the LITHO business for the first nine months of 2020 was EUR 8.3 million (USD 9.4 million), a 17.8% decrease compared to EUR 10.1 million (USD 11.3 million) for the first nine months of 2019.

Total revenue in the Distribution business for the first nine months of 2020 was EUR 11.0 million (USD 12.4 million), a 5.6% decrease compared to EUR 11.6 million (USD 13.0 million) for the first nine month of 2019.

Gross profit for the first nine months of 2020 was EUR 11.4 million (USD 12.8 million), compared to EUR 15.9 million (USD 17.8 million) for the year-ago period. Gross profit margin on net sales was 43.2% for the first nine months of 2020, compared to 48.2% in the year-ago period. The decline in gross profit year-over-year was due in part to lower sales in the HIFU business driven by COVID-19.

Operating expenses were EUR 12.8 million (USD 14.5 million) for the first nine months of 2020, compared to EUR 13.7 million (USD 15.4 million) for the same period in 2019.

Operating loss for the first nine months of 2020 was EUR 1.5 million (USD 1.6 million), compared to an operating profit of EUR 2.1 million (USD 2.4 million) for the same period of 2019.

Net loss for the first nine months of 2020 was EUR 2.5 million (USD 2.8 million), or EUR (0.09) per diluted share, as compared to a net income of EUR 2.5 million (USD 2.8 million), or EUR 0.09 per diluted share in the year-ago period.

As of September 30, 2020, the Company recorded a strong cash position of EUR 19.9 million (USD 23.4 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, November 19, 2020. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast Thursday, November 19, 2020 @ 8:30am Eastern TimeDomestic: 877-451-6152International: 201-389-0879Passcode: 13712293Webcast: http://public.viavid.com/index.php?id=142115

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: Sept. 30, Sept. Sept. 30, Sept. 2020 30, 2020 30, Euros 2019 $US 2019 Euros $USSales of medical equipment 5,984 6,877 7,080 7,571 Net Sales of RPP and 1,207 1,228 1,428 1,352 LeasesSales of spare parts, 2,255 2,187 2,668 2,407 supplies and ServicesTOTAL NET SALES 9,446 10,292 11,176 11,330 Other revenues (13) 15 (16) 17 TOTAL REVENUES 9,433 10,307 11,160 11,347 Cost of sales (5,469) (5,641) (6,470) (6,209) GROSS PROFIT 3,964 4,667 4,690 5,137 Research & development (1,090) (886) (1,289) (975) expensesS, G & A expenses (3,167) (3,522) (3,748) (3,877) Total operating expenses (4,257) (4,408) (5,037) (4,852) OPERATING PROFIT (LOSS) (293) 259 (347) 285 Interest (expense) income, (12) (40) (14) (44) netCurrency exchange gains (574) 684 (679) 753 (loss), netINCOME (LOSS) BEFORE TAXES (879) 903 (1,040) 994 AND MINORITY INTERESTIncome tax (expense) (122) (120) (145) (132) creditNET INCOME (LOSS) (1,001) 783 (1,185) 862

Earning per share ? Basic (0.03) 0.03 (0.04) 0.03 Average number of shares 29,144,010 28,997,886 29,144,010 28,997,886 used in computation of EPSEarning per share ? (0.03) 0.03 (0.04) 0.03 DilutedAverage number of sharesused in computation of EPSfor positive net income 29,144,010 29,622,866 29,144,010 29,622,866

NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average three months noon buying rate of 1 Euro = 1.1832 USD, and 2019 average three months noon buying rate of 1 Euro = 1.1008 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. Sept. 30, Sept. 2020 30, 2020 30, Euros 2019 $US 2019 Euros $USSales of medical 16,083 22,139 18,204 24,797 equipmentNet Sales of RPP and 3,409 4,028 3,858 4,512 LeasesSales of spare parts, 6,795 6,742 7,691 7,551 supplies and ServicesTOTAL NET SALES 26,287 32,909 29,753 36,860 Other revenues 11 15 12 17 TOTAL REVENUES 26,298 32,924 29,765 36,877 Cost of sales (14,948) (17,061) (16,919) (19,110) GROSS PROFIT 11,350 15,863 12,846 17,768 Research & development (3,058) (2,884) (3,461) (3,231) expensesS, G & A expenses (9,743) (10,857) (11,027) (12,161) Total operating expenses (12,800) (13,742) (14,488) (15,392) OPERATING PROFIT (LOSS) (1,451) 2,121 (1,642) 2,376 Interest (expense) (51) (103) (58) (115) income, netCurrency exchange gains (631) 788 (714) 883 (loss), netINCOME (LOSS) BEFORETAXES AND MINORITY (2,133) 2,807 (2,415) 3,144 INTERESTIncome tax (expense) (351) (317) (397) (356) creditNET INCOME (LOSS) (2,484) 2,490 (2,812) 2,789

Earning per share ? Basic (0.09) 0.09 (0.10) 0.10 Average number of sharesused in computation of 29,142,788 28,997,866 29,142,788 28,997,866 EPSEarning per share ? (0.09) 0.08 (0.10) 0.09 DilutedAverage number of sharesused in computation ofEPS for positive net 29,142,788 29,623,683 29,142,788 29,623,683 income

NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average nine months noon buying rate of 1 Euro = 1.1319 USD, and 2019 average nine months noon buying rate of 1 Euro = 1.1201 USD

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

Sept. June. Sept. June 30, 30, 30, 30, 2020 2020 2020 2020 Euros Euros $US $USCash, cash equivalents and 19,929 15,704 23,364 17,647 short-term treasury investmentsAccount receivables, net 11,572 12,607 13,567 14,167 Inventory 9,455 9,365 11,084 10,523 Other current assets 604 631 708 709 TOTAL CURRENT ASSETS 41,560 38,307 48,722 43,046 Property, plant and equipment, net 5,928 6,072 6,950 6,823 Goodwill 2,412 2,412 2,827 2,710 Other non-current assets 1,739 1,794 2,039 2,016 TOTAL ASSETS 51,639 48,585 60,538 54,596 Accounts payable & other accrued 9,122 9,618 10,694 10,808 liabilitiesDeferred revenues, current portion 2,695 2,519 3,160 2,831 Short term borrowing 1,459 887 1,711 997 Other current liabilities 5,825 1,820 6,829 2,045 TOTAL CURRENT LIABILITIES 19,102 14,845 22,394 16,681 Obligations under operating and 1,724 1,906 2,021 2,141 finance leases non-currentLong term debt, non-current 1,219 1,193 1,429 1,341 Deferred revenues, non-current 821 1,100 963 1,236 Other long term liabilities 3,626 3,673 4,251 4,128 TOTAL LIABILITIES 26,493 22,717 31,059 25,528 TOTAL SHAREHOLDERS?EQUITY 25,146 25,867 29,480 29,068 TOTAL LIABILITIES & SHAREHOLDERS? 51,639 48,585 60,538 54,596 EQUITY

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1723 USD, on September 30, 2020 and at the noon buying rate of 1 Euro = 1.1237 USD, on June 30, 2020.

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

Sept. June Sept. June 30 30, 30, 2020 30, 2020 2020 2020 $US Euros Euros $USNET INCOME (LOSS) (2,484) (1,483) (2,812) (1,640)Adjustments to reconcile netincome (loss) to net cash 2,211 1,612generated by (used in) 1,457 2,503operating activitiesOPERATING CASH FLOW (273) (25) (309) (28)Increase/Decrease inoperating assets and (1,735) (1,774) (1,964) (1,963)liabilitiesNET CASH GENERATED BY (USED (2,008) (1,799) (2,273) (1,991)IN) OPERATING ACTIVITIESShort term investments^(1) (1,708) (1,786) (1,933) (1,976)Additions to capitalizedassets produced by the (1,508) (844) (1,707) (933)company and other capitalexpendituresNET CASH GENERATED BY (USED (3,216) (2,630) (3,640) (2,909)IN) INVESTING ACTIVITIESNET CASH GENERATED BY (USED 2,248 (2,444) 2,544 (2,704)IN) FINANCING ACTIVITIESNET EFFECT OF EXCHANGE RATECHANGES ON CASH AND CASH 312 (44) 1,281 (204)EQUIVALENTSNET INCREASE (DECREASE) IN (2,665) (6,968) (2,088) (7,808)CASH AND CASH EQUIVALENTS

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

NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average nine months noon buying rate of 1 Euro = 1.1319 USD, and 2019 average nine months noon buying rate of 1 Euro = 1.1201 USD





EDAP TMS S.A.UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISIONNINE MONTHS ENDED SEPTEMBER 30, 2020(Amounts in thousands of Euros)

HIFU ESWL Distribution Reconciling Total After Division Division Division Items Consolidation Sales of 3,095 3,408 9,580 16,083goodsSales ofRPPs & 2,594 659 156 3,409 LeasesSales ofspare parts 1,351 4,217 1,226 6,795 & servicesTOTAL NETSALES 7,041 8,284 10,962 26,287

Otherrevenues 11 0 0 11

TOTAL 7,052 8,284 10,962 26,298 REVENUESGROSS PROFIT 55.0(% of Total 3,877 % 3,490 42.1% 3,982 36.3% 11,350 43.2%Revenues) (1,006) (289) (3,058) Research & (1,763)DevelopmentTotal SG&Aplus (2,870) (2,154) (3,599) (1,119) (9,743) depreciation

OPERATING PROFIT (756) 331 94 (1,119) (1,451)(LOSS)



Attachment

-- 2020-11-18 -- EDAP 3Q 2020 Press Release Final