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EDAP Reports Fourth Quarter 2020 Results and Provides Operational Update

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EDAP TMS S.A.
·15-min read
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  • Generated record fourth quarter revenue of EUR 15.4 million (USD 18.3 million), an increase of 28% year-over-year; HIFU revenue up 51% year-over-year

  • Generated €41.7 million revenue and profitable operating result for the full year 2020.

  • Completed sales to renowned healthcare institutions, such as University of California, San Francisco Medical Center and Cleveland Clinic

  • Strong and increased cash position of EUR 24.7 million (USD 30.2 million) as of December 31, 2020

  • Company to host a conference call tomorrow, March 31, at 8:30 am ET

LYON, France, March 30, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the fourth quarter of 2020 and provided an update on strategic and operational developments.

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “During the fourth quarter and full year 2020, we made great strides toward our mission of becoming a leader in the field of high intensity focused ultrasound. We delivered sequential revenue growth each quarter of the year notwithstanding the impact of the pandemic. We ended on a high note by delivering 28% year-over-year total revenue growth and 51% year-over-year HIFU revenue growth during the quarter, and in the process welcomed University of California, San Francisco Medical Center (UCSF) and Cleveland Clinic to our growing roster of highly regarded Focal One customers. This success was driven not only by the growing recognition of Focal One as a new treatment paradigm in the non-invasive ablation of cancerous prostate tissue, but also our strategic licensing agreement with Exact Imaging, and its lead product Exact Vu, which provides us with a comprehensive urology solution.

“Notably, we achieved all of this while delivering operating profitability for both the fourth quarter and full year and ended the year with an increased cash position of EUR 24.7 million. I believe we are well positioned to continue this momentum through 2021.”

Fourth Quarter 2020 Results

Total revenue for the fourth quarter 2020 was EUR 15.4 million (USD 18.3 million), an increase of 28.2% compared to total revenue of EUR 12.0 million (USD 13.3 million) for the same period in 2019.

Total revenue in the HIFU business for the fourth quarter 2020 was EUR 4.4 million (USD 5.2 million), a 50.8% increase compared to EUR 2.9 million (USD 3.2 million) for the fourth quarter of 2019.

Total revenue in the LITHO business for the fourth quarter 2020 was EUR 4.6 million (USD 5.5 million), a 10.6% increase compared to EUR 4.2 million (USD 4.6 million) for the fourth quarter of 2019.

Total revenue in the Distribution business for the fourth quarter 2020 was EUR 6.4 million (USD 7.6 million), a 29.7% increase compared to EUR 4.9 million (USD 5.5 million) for the fourth quarter of 2019.

Gross profit for the fourth quarter 2020 was EUR 7.0 million (USD 8.4 million), compared to EUR 5.1 million (USD 5.7 million) for the year-ago period. Gross profit margin on net sales was 45.8% in the fourth quarter of 2020, compared to 43.0% in the year-ago period. The increase in gross profit year-over-year was due to higher HIFU equipment sales.

Operating expenses were EUR 5.3 million (USD 6.3 million) for the fourth quarter of 2020, compared to EUR 5.1 million (USD 5.6 million) for the same period in 2019.

Operating profit for the fourth quarter of 2020 was EUR 1.7 million (USD 2.1 million), compared to an operating profit of EUR 0.08 million (USD 0.09 million) in the fourth quarter of 2019.

Net income for the fourth quarter of 2020 was EUR 0.8 million (USD 0.9 million), or EUR 0.03 per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.1 million), or EUR (0.03) per diluted share in the year-ago period.

Full Year 2020 Results

Total revenue for the full year 2020 was EUR 41.7 million (USD 47.8 million), a decrease of 7% compared to total revenue of EUR 44.9 million (USD 50.2 million) for the full year 2019. Full year revenue reflects the impact of the ongoing COVID-19 pandemic on the company’s activities.

Total revenue in the HIFU business for the full year 2020 was EUR 11.4 million (USD 13.1 million), a 19% decrease compared to EUR 14.1 million (USD 15.8 million) for the full year 2019.

Total revenue in the LITHO business for the full year 2020 was EUR 12.9 million (USD 14.8 million), a 9.2% decrease compared to 14.2 million (USD 15.9 million) for the full year 2019.

Total revenue in the Distribution business for the full year 2020 was EUR 17.3 million (USD 19.9 million), a 4.6% increase compared to EUR 16.6 million (USD 18.5 million) for the full year 2019.

Gross profit for the full year 2020 was EUR 18.4 million (USD 21.1 million), compared to EUR 21.0 million (USD 23.5 million) for the full year 2019. Gross profit margin on net sales was 44.1% for the full year 2020, compared to 46.8% in the prior year. 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 18.1 million (USD 20.8 million) for the full year 2020, compared to EUR 18.8 million (USD 21.0 million) for the full year 2019.

Operating profit for the full year 2020 was EUR 0.3 million (USD 0.3 million), compared to an operating profit of EUR 2.2 million (USD 2.5 million) for the full year 2019.

Net loss for the full year 2020 was EUR 1.7 million (USD 2.0 million), or EUR (0.06) per diluted share, as compared to a net income of EUR 1.5 million (USD 1.7 million), or EUR 0.05 per diluted share in the prior year.

As of December 31, 2020, the Company recorded a strong cash position of EUR 24.7 million (USD 30.2 million).

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, March 31, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Call & Webcast
Wednesday, March 31, 2021 @ 8:30am Eastern Time
Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13717550
Webcast: http://public.viavid.com/index.php?id=143913

Following the live call, a replay will be available on the Company's website, www.edap-tms.com under "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 Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com

Investor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
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:

Dec. 31,
2020
Euros



Dec. 31,
2019
Euros

Dec. 31,
2020
$US

Dec. 31,
2019
$US

Sales of medical equipment

11,439

7,972

13,661

8,876

Net Sales of RPP and Leases

1,336

1,719

1,596

1,914

Sales of spare parts, supplies and Services

2,587

2,259

3,089

2,515

TOTAL NET SALES

15,363

11,950

18,346

13,305

Other revenues

1

37

2

42

TOTAL REVENUES

15,364

11,988

18,348

13,346

Cost of sales

(8,335)

(6,848)

(9,953)

(7,624)

GROSS PROFIT

7,029

5,139

8,394

5,722

Research & development expenses

(1,439)

(844)

(1,718)

(939)

S, G & A expenses

(3,871)

(4,216)

(4,622)

(4,694)

Total operating expenses

(5,310)

(5,060)

(6,341)

(5,633)

OPERATING PROFIT (LOSS)

1,720

79

2,053

88

Interest (expense) income, net

(46)

(43)

(55)

(48)

Currency exchange gains (loss), net

(728)

(652)

(869)

(726)

INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST

945

(616)

1,129

(685)

Income tax (expense) credit

(165)

(362)

(197)

(403)

NET INCOME (LOSS)

780

(978)

932

(1,088)

Earning per share – Basic

0.03

(0.03)

0.03

(0.04)

Average number of shares used in computation of EPS

29,164,983

29,047,028

29,164,983

29,047,028

Earning per share – Diluted

0.03

(0.03)

0.03

(0.04)

Average number of shares used in computation of EPS for positive net income

30,222,258

29,047,028

30,222,258

29,047,028

NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average three months’ noon buying rate of 1 Euro = 1.1942 USD, and 2019 average three months noon buying rate of 1 Euro = 1.1133 USD

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

Twelve Months Ended:

Twelve Months Ended:

Dec. 31,
2020
Euros



Dec. 31,
2019
Euros

Dec. 31,
2020
$US

Dec. 31,
2019
$US

Sales of medical equipment

27,523

30,111

31,581

33,678

Net Sales of RPP and Leases

4,745

5,747

5,445

6,428

Sales of spare parts, supplies and Services

9,382

9,001

10,765

10,067

TOTAL NET SALES

41,649

44,859

47,791

50,173

Other revenues

12

52

14

59

TOTAL REVENUES

41,662

44,912

47,805

50,231

Cost of sales

(23,283)

(23,909)

(26,716)

(26,741)

GROSS PROFIT

18,379

21,002

21,089

23,490

Research & development expenses

(4,496)

(3,728)

(5,159)

(4,169)

S, G & A expenses

(13,614)

(15,074)

(15,621)

(16,859)

Total operating expenses

(18,110)

(18,802)

(20,780)

(21,029)

OPERATING PROFIT (LOSS)

269

2,201

309

2,461

Interest (expense) income, net

(98)

(146)

(112)

(163)

Currency exchange gains (loss), net

(1,359)

136

(1,559)

152

Other income, net

-

-

(1)

-

INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST

(1,188)

2,191

(1,363)

2,451

Income tax (expense) credit

(516)

(679)

(592)

(760)

NET INCOME (LOSS)

(1,704)

1,512

(1,955)

1,691

Earning per share – Basic

(0.06)

0.05

(0.07)

0.06

Average number of shares used in computation of EPS

29,148,108

29,016,118

29,148,108

29,016,118

Earning per share – Diluted

(0.06)

0.05

(0.07)

0.06

Average number of shares used in computation of EPS for positive net income

29,148,108

29,615,466

29,148,108

29,615,466

NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average twelve months’ noon buying rate of 1 Euro = 1.1474 USD, and 2019 average twelve months noon buying rate of 1 Euro = 1.1184 USD

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

Dec. 31,
2020
Euros



Sept. 30,
2020
Euros

Dec. 31,
2020
$US

Sept. 30,
2020
$US

Cash, cash equivalents and short-term treasury investments

24,696

19,929

30,201

23,364

Account receivables, net

12,339

11,572

15,090

13,567

Inventory

7,989

9,455

9,771

11,084

Other current assets

369

604

451

708

TOTAL CURRENT ASSETS

45,393

41,560

55,513

48,722

Property, plant and equipment, net

5,599

5,928

6,847

6,950

Goodwill

2,412

2,412

2,949

2,827

Other non-current assets

1,790

1,739

2,189

2,039

TOTAL ASSETS

55,193

51,639

67,498

60,538

Accounts payable & other accrued liabilities

10,485

9,122

12,823

10,694

Deferred revenues, current portion

2,701

2,695

3,304

3,160

Short term borrowing

2,638

1,459

3,227

1,711

Other current liabilities

5,679

5,825

6,945

6,829

TOTAL CURRENT LIABILITIES

21,504

19,102

26,298

22,394

Obligations under operating and finance leases non-current

1,653

1,724

2,022

2,021

Long term debt, non-current

1,143

1,219

1,397

1,429

Deferred revenues, non-current

926

821

1,132

963

Other long term liabilities

3,720

3,626

4,549

4,251

TOTAL LIABILITIES

28,945

26,493

35,399

31,059

TOTAL SHAREHOLDERS’EQUITY

26,248

25,146

32,099

29,480

TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY

55,193

51,639

67,498

60,538

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.2229 USD on December 31, 2020 and at the noon buying rate of 1 Euro = 1.1723 USD, on September 30, 2020

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

Dec. 31, 2020
Euros

Sept. 30, 2020
Euros

Dec. 31, 2020
$US

Sept. 30 2020
$US

NET INCOME (LOSS)

(1,704)

(2,484)

(1,955)

(2,812)

Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)

3,790

2,211

4,349

2,503

OPERATING CASH FLOW

2,087

(273)

2,394

(309)

Increase/Decrease in operating assets and liabilities

(110)

(1,735)

(126)

(1,964)

NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES

1,977

(2,008)

2,269

(2,273)

Short term investments(2)

-

(1,708)

-

(1,933)

Additions to capitalized assets produced by the company and other capital expenditures

(2,011)

(1,508)

(2,307)

(1,707)

NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES

(2,011)

(3,216)

(2,307)

(3,640)

NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES

3,201

2,248

3,673

2,544

NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

642

312

3,118

1,281

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

3,810

(2,665)

6,752

(2,088)

(1) including Share based compensation expenses for 160 thousands of Euros at the end of December 2020, and 134 thousands of Euros at the end of September 2020

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

NOTE: Translated for convenience of the reader to U.S. dollars at the 2020 average twelve months’ noon buying rate of 1 Euro = 1.1474 and 2020 average nine months’ noon buying rate of 1 Euro = 1.1319 USD.

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
TWELVE MONTHS ENDED DECEMBER 31, 2020
(Amounts in thousands of Euros)



HIFU
Division



ESWL
Division



Distribution
Division



Reconciling
Items



Total After Consolidation



Sales of goods



6,000



6,248



15,274



27,523

Sales of RPPs & Leases

3,594

927

224

4,745

Sales of spare parts & services

1,831

5,707

1,844

9,382

TOTAL NET SALES

11,425

12,882

17,342

41,649

Other revenues

12

0

0

12

TOTAL REVENUES

11,438

12,882

17,342

41,662

GROSS PROFIT
(% of Total Revenues)

6,293

55.0 %

5,649

43.9%

6,436

37.1%

18,379

44.1%



Research & Development



(2,583)

(1,555)

(358)

(4,496)

Total SG&A plus depreciation

(4,156)

(3,016)

(4,976)

(1,465)

(13,614)



OPERATING PROFIT (LOSS)



(445)



1,078



1,102



(1,465)



269

Attachment