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

 

August 24, 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: August 24, 2022

 

EDAP TMS S.A.

 

 

/s/ FRANCOIS DIETSCH
FRANCOIS DIETSCH
CHIEF FINANCIAL OFFICER

 

 

 

 

 

 

 

 
 

 

EDAP Reports Second Quarter 2022 Results

 

- Announced Focal One® HIFU reimbursement raised to urology APC Level 6 under CMS Outpatient Prospective Payment System (OPPS) proposed rule for CY23

 

- Second quarter 2022 total revenue of approximately EUR 14.2 million (USD 15.0 million), an increase of 36.7% as compared to EUR 10.4 million (USD 12.4 million) for the second quarter 2021

 

- 79% growth in HIFU revenues for the first half of 2022 compared to same period in 2021

 

- Strong cash position of $48.5 million as of June 30, 2022

 

- Company to host Focal One Expert User Panel event in New York City on Thursday, September 29

 

- Second quarter conference call and webcast scheduled for tomorrow, Thursday, August 25, at 8:30 am ET

 

LYON, France, August 24, 2022 -- EDAP TMS SA (Nasdaq: EDAP) (the “Company”), a global leader in robotic energy-based therapies, announced today unaudited financial results for the second quarter 2022.

 

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “For the second quarter 2022, we generated strong year-over-year revenue growth of nearly 37% driven by contribution from all three business segments, including our core HIFU business, which grew nearly 50% over the prior year period. The measured investments that we continue to make in our US team and infrastructure continue to bear fruit as HIFU, and specifically Focal One, becomes integral to the modern prostate cancer treatment paradigm.”

 

“Our pipeline of sales prospects continues to grow, driven by a combination of new world-renowned healthcare institutions that have adopted Focal One, and champion this technology, and our growing presence at important medical meetings such as the annual meeting of the American Urological Association this past May. These trends, together with the proposed increase in reimbursement for CY23 indicated in the preliminary CMS Outpatient Prospective Payment System (OPPS) rule, give me great optimism for the future adoption of our Focal One platform.” Mr. Oczachowski concluded.

 

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, “Following the close of the second quarter, we learned that the Centers for Medicare and Medicaid Services, in its proposed OPPS rule for calendar year 2023, raised Focal One HIFU reimbursement to APC Level 6 from Level 5 currently. It is difficult to overstate the positive impact such a change would have on expanding patient procedure access should the increase stand in the final rule, which we expect to be published in November. We are very pleased with this proposed increase to hospital reimbursement and believe it more accurately reflects the significant clinical value that HIFU brings to the urology suite.”

 

“We also will be hosting an in-person Focal One Expert User Panel Event in New York City in September, to coincide with Prostate Cancer Awareness Month. The event will feature presentations from several renowned thought leaders and will also include a demonstration of the Focal One procedure.”

 

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Year-to-Date Results

 

Total revenue for the six months ended June 30, 2022, was EUR 27.1 million (USD 29.5 million), an increase of 31.5% from total revenue of was EUR 20.7 million (USD 24.8 million) for the same period in 2021.

 

Total revenue in the HIFU business for the six months ended June 30, 2022, was EUR 6.8 million (USD 7.4 million), an increase of 78.8% as compared to EUR 3.8 million (USD 4.6 million) for the six months ended June 30, 2021.

 

Total revenue in the LITHO business for the six months ended June 30, 2022, was EUR 5.8 million (USD 6.3 million), an increase of 11.6% from EUR 5.2 million (USD 6.2 million) for the six months ended June 30, 2021.

 

Total revenue in the Distribution business for the six months ended June 30, 2022, was EUR 14.6 million (USD 15.9 million), a 24.8% increase compared to EUR 11.7 million (USD 14.0 million) for the six months ended June 30, 2021.

 

Gross profit for the six months ended June 30, 2022, was EUR 12.0 million (USD 13.0 million), compared to EUR 8.6 million (USD 10.3 million) for the year-ago period. Gross profit margin on net sales was 44.0% for the six months ended June 30, 2022, compared to 41.6% for the comparable period in 2021. The increase in gross profit year-over-year was due to higher sales effect on fixed costs, particularly in the HIFU business.

 

Operating expenses were EUR 12.5 million (USD 13.6 million) for the six months ended June 30, 2022, compared to EUR 8.8 million (USD 10.5 million) for the same period in 2021.

 

Operating loss for the six months ended June 30, 2022, was EUR 0.5 million (USD 0.6 million), compared to an operating loss of EUR 0.2 million (USD 0.2 million) for the six months ended June 30, 2021.

 

Net income for the six months ended June 30, 2022, was EUR 2.2 million (USD 2.4 million), or EUR 0.06 per diluted share, as compared to a net income of EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share in the year-ago period.

 

As of June 30, 2022, the company held cash and cash equivalents of EUR 46.3 million (USD 48.5 million), as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

 

Second Quarter 2022 Results

 

Total revenue for the second quarter 2022 was EUR 14.2 million (USD 15.0 million), a 36.7% increase as compared to total revenue of EUR 10.4 million (USD 12.4 million) for the same period in 2021.

 

Total revenue in the HIFU business for the second quarter 2022 was EUR 3.0 million (USD 3.2 million), an increase of 49.3% as compared to EUR 2.0 million (USD 2.4 million) for the second quarter of 2021.

 

Total revenue in the LITHO business for the second quarter 2022 was EUR 3.6 million (USD 3.8 million), an increase of 55.7% from was EUR 2.3 million (USD 2.7 million) for the second quarter of 2021.

 

Total revenue in the Distribution business for the second quarter 2022 was EUR 7.6 million (USD 8.1 million), a 25.5% increase compared to EUR 6.1 million (USD 7.3 million) for the second quarter of 2021.

 

Gross profit for the second quarter 2022 was EUR 6.2 million (USD 6.6 million), compared to EUR 4.2 million (USD 5.1 million) for the year-ago period. Gross profit margin on net sales was 43.8% in the second quarter of 2022, compared to 40.7% in the year-ago period. The increase in gross profit year-over-year was driven by the higher sales effect on fixed costs.

 

Operating expenses were EUR 6.6 million (USD 7.0 million) for the second quarter of 2022, compared to EUR 4.6 million (USD 5.6 million) for the same period in 2021.

 

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Operating loss for the second quarter of 2022 was EUR 0.4 million (USD 0.5 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the second quarter of 2021.

 

Net income for the second quarter of 2022 was EUR 1.8 million (USD 1.9 million), or EUR 0.05 per diluted share, as compared to a net loss of EUR 0.4 million (USD 0.5 million), or EUR 0.01 per diluted share in the year-ago period.

 

In-person Focal One Expert User Panel Event

The management team of EDAP will host a In-person Focal One Expert User Panel Event in New York City on Thursday, September 29.
https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MjAxNg==

 

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, August 25, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

 

Conference Call & Webcast
Thursday, August 25, 2022 @ 8:30am Eastern Time

Domestic: 877-451-6152

International: 201-389-0879

Passcode: 13731177

Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1558239&tp_key=295933838c

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.

 

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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

 

 

 

 

 

 

 

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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:
    June 30,   June 30,   June 30,   June 30,
    2022   2021   2022   2021
    Euros   Euros   $US   $US
Sales of medical equipment     9,684       6,696       10,245       8,051  
Net Sales of RPP and Leases     1,646       1,265       1,741       1,521  
Sales of spare parts, supplies and Services     2,820       2,387       2,984       2,870  
TOTAL NET SALES     14,151       10,349       14,969       12,443  
Other revenues     —         1       —         2  
TOTAL REVENUES     14,151       10,350       14,969       12,445  
Cost of sales     (7,949 )     (6,134 )     (8,409 )     (7,376 )
GROSS PROFIT     6,201       4,216       6,560       5,069  
Research & development expenses     (1,174 )     (925 )     (1,242 )     (1,112 )
S, G & A expenses     (5,455 )     (3,718 )     (5,770 )     (4,470 )
Total operating expenses     (6,629 )     (4,642 )     (7,012 )     (5,582 )
OPERATING PROFIT (LOSS)     (427 )     (427 )     (452 )     (513 )
Interest (expense) income, net     (29 )     (20 )     (31 )     (25 )
Currency exchange gains (loss), net     2,412       82       2,551       98  
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST     1,955       (365 )     2,068       (439 )
Income tax (expense) credit     (128 )     (58 )     (136 )     (70 )
NET INCOME (LOSS)     1,827       (424 )     1,933       (509 )
Earning per share – Basic     0.05       (0.01 )     0.06       (0.02 )
Average number of shares used in computation of EPS     33,469,053       32,220,414       33,469,053       32,220,414  
Earning per share – Diluted     0.05       (0.01 )     0.06       (0.02 )
Average number of shares used in computation of EPS for positive net income     34,130,859       32,220,414       34,130,859       32,220,414  

 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average three months’ noon buying rate of 1 Euro = 1.0579 USD, and 2021 average three months noon buying rate of 1 Euro = 1.2024 USD 

 

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EDAP TMS S.A.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Amounts in thousands of Euros and U.S. Dollars, except per share data)

 

    Six Months Ended:   Six Months Ended:
    June 30,   June 30,   June 30,   June 30,
    2022   2021   2022   2021
    Euros   Euros   $US   $US
Sales of medical equipment     18,650       13,387       20,287       16,075  
Net Sales of RPP and Leases     2,963       2,477       3,223       2,975  
Sales of spare parts, supplies and Services     5,536       4,784       6,021       5,744  
TOTAL NET SALES     27,148       20,648       29,531       24,794  
Other revenues     —         4       —         5  
TOTAL REVENUES     27,148       20,653       29,531       24,799  
Cost of sales     (15,190 )     (12,066 )     (16,524 )     (14,488 )
GROSS PROFIT     11,958       8,587       13,008       10,311  
Research & development expenses     (2,255 )     (1,776 )     (2,453 )     (2,132 )
S, G & A expenses     (10,242 )     (6,998 )     (11,141 )     (8,403 )
Total operating expenses     (12,497 )     (8,774 )     (13,594 )     (10,536 )
OPERATING PROFIT (LOSS)     (539 )     (188 )     (586 )     (225 )
Interest (expense) income, net     (58 )     143       (63 )     172  
Currency exchange gains (loss), net     2,981       571       3,243       685  
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST     2,384       527       2,593       632  
Income tax (expense) credit     (200 )     (177 )     (218 )     (213 )
NET INCOME (LOSS)     2,184       350       2,375       420  
Earning per share – Basic     0.07       0.01       0.07       0.01  
Average number of shares used in computation of EPS     33,467,594       30,705,356       33,467,594       30,705,356  
Earning per share – Diluted     0.06       0.01       0.07       0.01  
Average number of shares used in computation of EPS for positive net income     34,075,033       31,994,402       34,075,033       31,994,402  

 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average six months’ noon buying rate of 1 Euro = 1.0878 USD, and 2021 average six months noon buying rate of 1 Euro = 1.2008 USD

 

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EDAP TMS S.A.

UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS

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

 

    June 30,   December 31,   June 30,   December 31,
    2022   2021   2022   2021
    Euros   Euros   $US   $US
Cash, cash equivalents and short-term treasury investments     46,334       47,183       48,507       53,405  
Account receivables, net     15,888       12,118       16,633       13,716  
Inventory     7,906       7,499       8,277       8,487  
Other current assets     725       581       759       658  
TOTAL CURRENT ASSETS     70,853       67,382       74,176       76,267  
Property, plant and equipment, net     5,820       5,173       6,093       5,855  
Goodwill     2,412       2,412       2,525       2,730  
Other non-current assets     2,210       2,260       2,314       2,558  
TOTAL ASSETS     81,294       77,226       85,107       87,409  
Accounts payable & other accrued liabilities     11,348       10,786       11,881       12,208  
Deferred revenues, current portion     3,958       3,408       4,143       3,857  
Short term borrowing     1,906       1,914       1,995       2,167  
Other current liabilities     2,590       1,843       2,711       2,086  
TOTAL CURRENT LIABILITIES     19,802       17,951       20,730       20,318  
Obligations under operating and finance leases non-current     1,427       1,318       1,494       1,492  
Long term debt, non-current     4,390       4,930       4,596       5,580  
Deferred revenues, non-current     351       440       368       498  
Other long term liabilities     3,060       2,534       3,204       2,868  
TOTAL LIABILITIES     29,029       27,172       30,391       30,755  
TOTAL SHAREHOLDERS’EQUITY     52,265       50,054       54,716       56,655  
TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY     81,294       77,226       85,107       87,409  

 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.0469 USD on June 30, 2022 and at the noon buying rate of 1 Euro = 1.1319 USD, on December 31, 2021

 

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EDAP TMS S.A.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Amounts in thousands of Euros)

 

    Six Months Ended   Twelve Months Ended   Six Months Ended   Twelve Months Ended
    June 30,   December 31,   June 30,   December 31,
    2022   2021   2022   2021
    (Euros)   (Euros)   ($US)   ($US)
NET INCOME (LOSS)     2,184       700       2,375       825  
Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)     1,967       3,225       2,140       3,801  
OPERATING CASH FLOW     4,151       3,925       4,515       4,626  
Increase/Decrease in operating assets and liabilities     (2,901 )     520       (3,156 )     613  
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES     1,250       4,445       1,359       5,239  
                                 
Additions to capitalized assets produced by the company and other capital expenditures     (1,192 )     (1,638 )     (1,297 )     (1,931 )
NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES     (1,192 )     (1,638 )     (1,297 )     (1,931 )
NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES     34       20,266       37       23,887  
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS     (941 )     (585 )     (4,997 )     (3,992 )
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS     (849 )     22,488       (4,898 )     23,204  

 

 

(1) including share based compensation expenses for 936 thousand of Euros for the six months ended June 30, 2022 and 1,900 thousand of Euros for the full year ended December 31, 2021.

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2022 average six months’ noon buying rate of 1 Euro = 1.0878 USD, and 2021 average twelve months noon buying rate of 1 Euro = 1.1787 USD

 

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EDAP TMS S.A.

UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION

SIX MONTHS ENDED JUNE 30, 2022

(Amounts in thousands of Euros)

 

    HIFU       ESWL       Distribution       Reconciling   Total After    
    Division       Division       Division       Items   Consolidation    
Sales of goods     3,606               2,291               12,753               —         18,650          
Sales of RPPs & Leases     2,252               569               141               —         2,963          
Sales of spare parts & services     937               2,917               1,682               —         5,536          
TOTAL NET SALES     6,795               5,777               14,576               —         27,148          
Other revenues     —                 —                 —                 —         —            
TOTAL REVENUES     6,795               5,777               14,576               —         27,148          
GROSS PROFIT (% of Net Sales)     3,797       55.9 %     2,536       43.9 %     5,624       38.6 %     —         11,958       44.0 %
Research & Development     (1,560 )             (466 )             (229 )             —         (2,255 )        
Total SG&A plus depreciation     (3,990 )             (1,356 )             (3,696 )             (1,201 )     (10,242 )        
OPERATING PROFIT (LOSS)     (1,752 )             714               1,699               (1,201 )     (539 )        

 

 

 

 

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