UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

 

PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

March 30, 2022

 

Commission File Number: 0-29374

 

EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F [ x]      Form 40-F [  ]

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

 

 

 

 

SIGNATURES

Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Date: March 30, 2022

 

EDAP TMS S.A.

 

 

 

/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER

 

 

 

 

 

 

EDAP Reports Fourth Quarter and Full Year 2021 Results

-Full year revenue of approximately EUR 44.1 million (USD 51.9 million) as compared to EUR 41.7 million (USD 47.8 million) for the full year 2020
-Full year US HIFU treatment volumes increased 65% over full year 2020; Strong cash position of EUR 47.2M€ (USD 53.4M) as of December 31, 2021
-Company to host a conference call tomorrow, Thursday, March 31, at 8:30 am ET

LYON, France, March 30, 2022 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the fourth quarter and full year 2021.

 

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “We finished 2021 on a positive note, having reported several U.S. Focal OneTM installations at renowned academic and community hospitals while growing our pipeline opportunities to their highest level since receiving regulatory approval of Focal One in mid-2018. At the same time, US HIFU treatment volumes, our most important leading indicator, were up 65% for the full year, reflecting ongoing growth in adoption of focal therapy by urologists. We continued to make measured investments in our US team, and with growing support for focal therapy as a necessary part of any comprehensive prostate oncology program, we entered 2022 with a right-sized, world class organization capable of capturing this significant untapped opportunity with our state-of-the-art HIFU technology.”

 

Full Year 2021 Results

 

Total revenue for the full year 2021 was EUR 44.1 million (USD 51.9 million), an increase of 5.8% from total revenue of 41.7 million (USD 47.8 million) for the full year 2020.

 

Total revenue in the HIFU business for the full year 2021 were EUR 9.9 million (USD 11.7 million), as compared to EUR 11.4 million (USD 13.1 million) for the full year 2020.

 

Total revenue in the LITHO business for the full year 2021 was EUR 11.0 million (USD 13.0 million), as compared to EUR 12.9 million (USD 14.8 million) for the full year 2020.

 

Total revenue in the Distribution business for the full year 2021 was EUR 23.1 million (USD 27.3 million), as compared to EUR 17.3 million (USD 19.9 million) for the full year 2020.

 

Gross profit for the full year 2021 was EUR 18.4 million (USD 21.7 million), compared to EUR 18.4 million (USD 21.1 million) for the full year 2020. Gross profit margin on net sales was 41.8 % for the full year 2021, compared to 44.1% for the comparable period in 2020.

 

Operating expenses were EUR 20.0 million (USD 23.6 million) for the full year 2021 as compared to EUR 18.1 million (USD 20.8 million) for the full year 2020.

 

Operating loss for the full year 2021 was EUR 1.6 million (USD 1.9 million), compared to an operating profit of EUR 0.3 million (USD 0.3 million) for the full year 2020.

 

Net income for the full year 2021 was EUR 0.7 million (USD 0.8 million), or EUR 0.02 per diluted share, as compared to a net loss of EUR 1.7 million (USD 2.0 million), or EUR 0.06 per diluted share for the full year 2020.

 

Fourth Quarter 2021 Results

 

Total revenue for the fourth quarter 2021 was EUR 14.0 million (USD 15.9 million), as compared to total revenue of EUR 15.4 million (USD 18.3 million) for the same period in 2020.

 

 

 

Total revenue in the HIFU business for the fourth quarter 2021 was EUR 4.2 million (USD 4.8 million), as compared to EUR 4.4 million (USD 5.2 million) for the fourth quarter of 2020.

 

Total revenue in the LITHO business for the fourth quarter 2021 was EUR 3.3 million (USD 3.8 million), as compared to EUR 4.6 million (USD 5.5 million) for the fourth quarter of 2020.

 

Total revenue in the Distribution business for the fourth quarter 2021 was EUR 6.4 million (USD 7.3 million), as compared to EUR 6.4 million (USD 7.6 million) for the fourth quarter of 2020.

 

Gross profit for the fourth quarter 2021 was EUR 6.2 million (USD 7.1 million), compared to EUR 7.0 million (USD 8.4 million) for the year-ago period. Gross profit margin on net sales was 44.5 % in the fourth quarter of 2021, compared to 45.8% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs.

 

Operating expenses were EUR 5.8 million (USD 6.5 million) for the fourth quarter of 2021, compared to EUR 5.3 million (USD 6.3 million) for the same period in 2020.

 

Operating profit for the fourth quarter of 2021 was EUR 0.5 million (USD 0.5 million), compared to an operating profit of EUR 1.7 million (USD 2.1 million) in the fourth quarter of 2020.

 

Net income for the fourth quarter of 2021 was EUR 1.4 million (USD 1.6 million), or EUR 0.04 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.

 

As of December 31, 2021, the company held cash and cash equivalents of EUR 47.2M (USD 53.4M) as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

 

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, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

 

Conference Call & Webcast
Thursday, March 31, 2022 @ 8:30am Eastern Time

Domestic: 877-451-6152
International: 201-389-0879
Passcode: 13727107
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1529371&tp_key=b54f335485

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

John Fraunces

LifeSci Advisors, LLC

917-355-2395

jfraunces@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,
2021
  Dec. 31,
2020
  Dec. 31,
2021
  Dec. 31,
2020
  

Euros

 

Euros

 

$US

 

$US

Sales of medical equipment   9,864    11,439    11,231    13,661 
Net Sales of RPP and Leases   1,387    1,336    1,579    1,596 
Sales of spare parts, supplies and Services   2,720    2,587    3,097    3,089 
TOTAL NET SALES   13,971    15,363    15,907    18,346 
Other revenues   1    1    2    2 
TOTAL REVENUES   13,973    15,364    15,909    18,348 
Cost of sales   (7,762)   (8,335)   (8,837)   (9,953)
GROSS PROFIT   6,211    7,029    7,072    8,394 
Research & development expenses   (562)   (1,439)   (640)   (1,718)
S, G & A expenses   (5,188)   (3,871)   (5,907)   (4,622)
Total operating expenses   (5,750)   (5,310)   (6,547)   (6,341)
OPERATING PROFIT (LOSS)   461    1,720    525    2,053 
Interest (expense) income, net   23    (46)   26    (55)
Currency exchange gains (loss), net   786    (728)   895    (869)
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST   1,270    945    1,446    1,129 
Income tax (expense) credit   95    (165)   108    (197)
NET INCOME (LOSS)
   1,365    780    1,554    932 
Earning per share – Basic   0.04    0.03    0.05    0.03 
Average number of shares used in computation of EPS   33,466,136    29,164,983    33,466,136    29,164,983 
Earning per share – Diluted   0.04    0.03    0.04    0.03 
Average number of shares used in computation of EPS for positive net income
   34,555,716    30,222,258    33,555,716    30,222,258 
                     

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average three months’ noon buying rate of 1 Euro = 1.1386 USD, and 2020 average three months noon buying rate of 1 Euro = 1.1942 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,
2021
  Dec. 31,
2020
  Dec. 31,
2021
  Dec. 31,
2020
   Euros  Euros  $US  $US
Sales of medical equipment   29,040    27,523    34,229    31,581 
Net Sales of RPP and Leases   4,968    4,745    5,856    5,445 
Sales of spare parts, supplies and Services   10,052    9,382    11,848    10,765 
TOTAL NET SALES   44,060    41,649    51,932    47,791 
Other revenues   6    12    7    14 
TOTAL REVENUES   44,065    41,662    51,939    47,805 
Cost of sales   (25,643)   (23,283)   (30,225)   (26,716)
GROSS PROFIT   18,422    18,379    21,714    21,089 
Research & development expenses   (3,402)   (4,496)   (4,010)   (5,159)
S, G & A expenses   (16,633)   (13,614)   (19,605)   (15,621)
Total operating expenses   (20,034)   (18,110)   (23,614)   (20,780)
OPERATING PROFIT (LOSS)   (1,612)   269    (1,900)   309 
Interest (expense) income, net   145    (98)   171    (112)
Currency exchange gains (loss), net   2,360    (1,359)   2,781    (1,559)
Other income, net   -    -    -    (1)
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST   893    (1,188)   1,052    (1,363)
Income tax (expense) credit   (193)   (516)   (227)   (592)
NET INCOME (LOSS)
   700    (1,704)   825    (1,955)
Earning per share – Basic   0.02    (0.06)   0.02    (0.07)
Average number of shares used in computation of EPS   33,457,469    29,148,108    33,457,469    29,148,108 
Earning per share – Diluted   0.02    (0.06)   0.02    (0.07)
Average number of shares used in computation of EPS for positive net income
   35,843,019    29,148,108    35,843,019    29,148,108 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2021 average twelve months’ noon buying rate of 1 Euro = 1.1787 USD, and 2020 average twelve months noon buying rate of 1 Euro = 1.1474 USD 

 

 

 

EDAP TMS S.A.

UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS

(Amounts in thousands of Euros and U.S. Dollars)

 

   Dec. 31,
2021
Euros
  Dec. 31,
2020
Euros
  Dec. 31,
2021
$US
  Dec. 31,
2020
$US
Cash, cash equivalents and short-term treasury investments   47,183    24,696    53,405    30,201 
Account receivables, net   12,118    12,339    13,716    15,090 
Inventory   7,499    7,989    8,487    9,771 
Other current assets   581    369    658    451 
TOTAL CURRENT ASSETS   67,382    45,393    76,267    55,513 
Property, plant and equipment, net   5,173    5,599    5,855    6,847 
Goodwill   2,412    2,412    2,730    2,949 
Other non-current assets   2,260    1,790    2,558    2,189 
TOTAL ASSETS   77,226    55,193    87,409    67,498 
Accounts payable & other accrued liabilities   10,786    10,485    12,208    12,823 
Deferred revenues, current portion   3,408    2,701    3,857    3,304 
Short term borrowing   1,914    2,638    2,167    3,227 
Other current liabilities   1,843    5,679    2,086    6,945 
TOTAL CURRENT LIABILITIES   17,951    21,504    20,318    26,298 
Obligations under operating and finance leases non-current   1,318    1,653    1,492    2,022 
Long term debt, non-current   4,930    1,143    5,580    1,397 
Deferred revenues, non-current   440    926    498    1,132 
Other long term liabilities   2,534    3,720    2,868    4,549 
TOTAL LIABILITIES   27,172    28,945    30,755    35,399 
TOTAL SHAREHOLDERS’EQUITY   50,054    26,248    56,655    32,099 
TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY   77,226    55,193    87,409    67,498 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1319 USD on December 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)

 

   Dec. 31, 2021
Euros
  Dec. 31, 2020
Euros
  Dec. 31, 2021
$US
  Dec. 31, 2020
$US
NET INCOME (LOSS)   700    (1,704)   825    (1,955)
Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)   3,225    3,790    3,801    4,349 
OPERATING CASH FLOW   3,925    2,087    4,626    2,394 
Increase/Decrease in operating assets and liabilities   520    (110)   613    (126)
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES   4,445    1,977    5,239    2,269 
Short term investments(2)   -    -    -    - 
Additions to capitalized assets produced by the company and other capital expenditures   (1,638)   (2,011)   (1,931)   (2,307)
NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES   (1,638)   (2,011)   (1,931)   (2,307)
NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES   20,266    3,201    23,887    3,673 
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS   (585)   642    (3,992)   3,118 
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS   22,488    3,810    23,204    6,752 

 

(1) including Share based compensation expenses for 1,900 thousand of Euros at the end of December 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 twelve months’ noon buying rate of 1 Euro = 1.1787 USD and 2020 average twelve months’ noon buying rate of 1 Euro = 1.1474 USD.

 

 

 

EDAP TMS S.A.

UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION

TWELVE MONTHS ENDED DECEMBER 31, 2021

(Amounts in thousands of Euros)

 

   HIFU
Division
     ESWL
Division
     Distribution
Division
     Reconciling
Items
     Total After Consolidation      
Sales of goods   4,515         4,236         20,289                  29,040      
Sales of RPPs & Leases   3,679         1,022         267                  4,968      
Sales of spare parts & services   1,715         5,758         2,578                  10,052      
TOTAL NET SALES
   9,910         11,016         23,134                  44,060      
Other revenues
   6         0         0                  6      
TOTAL REVENUES   9,915         11,016         23,134                  44,065      
GROSS PROFIT (% of Total Revenues)   4,604    46.4%   4,936    44.8%   8,882    38.4%            18,422    

41.8%

Research & Development   (2,238)        (835)        (329)                 (3,402)      
Total SG&A plus depreciation   (5,391)        (3,208)        (6,129)        (1,904)       (16,633)      
OPERATING PROFIT (LOSS)   (3,025)       893        2,424         (1,904)      (1,612)