EDAP Reports Fourth Quarter 2020 Results and Provides Operational Update

By EDAP TMS S.A.(GLOBE NEWSWIRE)
 
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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
[email protected]

Investor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
[email protected]

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 equipment11,439 7,972 13,661 8,876
Net Sales of RPP and Leases1,336 1,719 1,596 1,914
Sales of spare parts, supplies and Services2,587 2,259 3,089 2,515
TOTAL NET SALES15,363 11,950 18,346 13,305
Other revenues1 37 2 42
TOTAL REVENUES15,364 11,988 18,348 13,346
Cost of sales(8,335) (6,848) (9,953) (7,624)
GROSS PROFIT7,029 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 INTEREST945 (616) 1,129 (685)
Income tax (expense) credit(165) (362) (197) (403)

NET INCOME (LOSS)

780 (978) 932 (1,088)
Earning per share – Basic0.03 (0.03) 0.03 (0.04)
Average number of shares used in computation of EPS29,164,983 29,047,028 29,164,983 29,047,028
Earning per share – Diluted0.03 (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 equipment27,523 30,111 31,581 33,678
Net Sales of RPP and Leases4,745 5,747 5,445 6,428
Sales of spare parts, supplies and Services9,382 9,001 10,765 10,067
TOTAL NET SALES41,649 44,859 47,791 50,173
Other revenues12 52 14 59
TOTAL REVENUES41,662 44,912 47,805 50,231
Cost of sales(23,283) (23,909) (26,716) (26,741)
GROSS PROFIT18,379 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 EPS29,148,108 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 investments24,696 19,929 30,201 23,364
Account receivables, net12,339 11,572 15,090 13,567
Inventory7,989 9,455 9,771 11,084
Other current assets369 604 451 708
TOTAL CURRENT ASSETS45,393 41,560 55,513 48,722
Property, plant and equipment, net5,599 5,928 6,847 6,950
Goodwill2,412 2,412 2,949 2,827
Other non-current assets1,790 1,739 2,189 2,039
TOTAL ASSETS55,193 51,639 67,498 60,538
Accounts payable & other accrued liabilities10,485 9,122 12,823 10,694
Deferred revenues, current portion2,701 2,695 3,304 3,160
Short term borrowing2,638 1,459 3,227 1,711
Other current liabilities5,679 5,825 6,945 6,829
TOTAL CURRENT LIABILITIES21,504 19,102 26,298 22,394
Obligations under operating and finance leases non-current1,653 1,724 2,022 2,021
Long term debt, non-current1,143 1,219 1,397 1,429
Deferred revenues, non-current926 821 1,132 963
Other long term liabilities3,720 3,626 4,549 4,251
TOTAL LIABILITIES28,945 26,493 35,399 31,059
TOTAL SHAREHOLDERS’EQUITY26,248 25,146 32,099 29,480
TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY55,193 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 FLOW2,087 (273) 2,394 (309)
Increase/Decrease in operating assets and liabilities(110) (1,735) (126) (1,964)
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES1,977 (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 ACTIVITIES3,201 2,248 3,673 2,544
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS642 312 3,118 1,281
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS3,810 (2,665) 6,752 (2,088)

(1) includingShare based compensation expensesfor 160 thousands of Euros at the end of December 2020, and 134thousands 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 & Leases3,594 927 224 4,745
Sales of spare parts & services1,831 5,707 1,844 9,382

TOTAL NET SALES

11,425 12,882 17,342 41,649

Other revenues

12 0 0 12
TOTAL REVENUES11,438 12,882 17,342 41,662
GROSS PROFIT
(% of Total Revenues)		6,29355.0 %5,64943.9%6,43637.1% 18,37944.1%

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

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