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

May 16, 2024

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: May 16, 2024

EDAP TMS S.A.

 

/s/ KEN MOBECK
KEN MOBECK
CHIEF FINANCIAL OFFICER

 

 

 

 

 

EDAP Reports First Quarter 2024 Financial Results

 

-Strong Q1 2024 U.S. Focal One® HIFU procedure growth of +92% year-over-year

-Q1 2024 HIFU revenue of EUR 5.8 million ($6.3 million USD), an increase of 10.2% over Q1 2023

-Q1 2024 total revenue of EUR 14.9 million ($16.1 million USD) increased 0.8% over Q1 2023

-Company to host conference call and webcast today, May 16th, at 8:30 a.m. EDT

 

LYON, France, May 16, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited financial results for the first quarter of 2024.

 

“We are off to a strong start in 2024 driven by seven Focal One system placements in the quarter of 2024 and strong year over year procedure growth, reflecting the increasing acceptance of robotic HIFU for the management of prostate cancer,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “Important to note, the final results from the HIFI study, which is the single largest comparative study ever conducted evaluating robotic HIFU versus radical prostatectomy, were just presented at the119th Annual Meeting of the America Urology Association, held in San Antonio, Texas. The final results from the study were presented during the main plenary session of the AUA, which focused exclusively on evolving practices and changing treatment paradigms in urology. We believe the results from the HIFI Study clearly demonstrate that Focal One robotic HIFU delivers effective oncologic control as compared to surgery, but with the added potential benefit for improved functional outcomes with respect to maintaining both erectile function and urinary continence. Based on these definitive results, we expect to see both growing and continued adoption of our Focal One robotic HIFU technology in the management of localized prostate cancer.

 

“EDAP continues to make strategic investments to grow HIFU applications beyond prostate health. Last quarter, we received Breakthrough Device designation from the FDA for the application of Focal One robotic HIFU for treatment of deep infiltrating rectal endometriosis. As noted, our Phase 3 study completed patient enrollment in January, and we expect topline results from this study in the second half of 2024. Endometriosis represents a significant unmet medical need in women’s health, and we believe Focal One has the opportunity to become an important new treatment alternative to address this painful and debilitating condition which impacts thousands of women each year.

 

“Looking ahead in 2024, we believe Focal One will become an essential component to the urology suite, as an increasing number of patients seek out effective, less invasive treatment options to manage their prostate cancer. Our Focal One pipeline remains strong, and we continue to see broad acceptance of Focal One amongst leading academic and community medical practices. We also continue to see strong engagement across our regional capital and clinical sales teams, as they build world-class robotic HIFU treatment programs with the goal of helping more urology practices remain at the forefront of prostate cancer management.”

 

Business Update

 

·On May 6, 2024, the Company announced that final results from a large, prospective, multicenter, non-inferiority study, the HIFI Study, comparing Focal One® high intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) were presented at the 119th American Urological Association Annual Meeting (AUA 2024), which took place from May 3-6, 2024, in San Antonio, Texas, USA. Professor Pascal Rischmann of Rangueil University Hospital in Toulouse, France, and lead investigator of the HIFI Study, highlighted the final results from the study during an oral presentation at the AUA plenary session, “Paradigm-shifting, Practice-changing Clinical Trials in Urology”.

 

·On February 1, 2024, the Company announced that it completed enrollment for its Phase 3 study (Endo-HIFU-R2) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis. Results from the Phase 3 study are expected in the second half of 2024.

 

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·On January 2, 2024, the Company announced the appointments of Ken Mobeck as its Chief Financial Officer of EDAP worldwide, and Francois Dietsch as Global Chief Accounting Officer. Both appointments became effective as of January 1, 2024.

 

Clinical Pipeline Update

 

Endometriosis Program

 

·On March 4, 2024, the Company announced that it received Breakthrough Device designation by the US Food and Drug Administration (FDA) for the treatment of deep infiltrating endometriosis (DIE). FDA’s Breakthrough Device designation is granted to products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This unique program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review.

 

·On February 1, 2024, EDAP announced completion of enrollment in the Phase 3 double blinded, randomized controlled trial evaluating Focal One HIFU for the treatment of deep infiltrating rectal endometriosis. Results from the study are expected in the second half of 2024.

 

Upcoming Meetings and Events

 

·Jefferies Global Healthcare Conference, June 5-6, 2024, in New York City

 

First Quarter 2024 Results

 

Total revenue for the first quarter of 2024 was EUR 14.9 million (USD 16.1 million), an increase of 0.8% as compared to total revenue of EUR 14.8 million (USD 15.9 million) for the same period in 2023.

 

Total revenue in the HIFU business for the first quarter of 2024 was EUR 5.8 million (USD 6.3 million), as compared to EUR 5.3 million (USD 5.7 million) for the first quarter of 2023. The Company recorded a 55.7% year-over-year growth in disposables revenues, reflecting strong procedure growth. During the quarter, the Company placed 7 Focal One systems, which included five capital sales, versus 7 Focal One placements in the first quarter of 2023.

 

Total revenue in the LITHO business for the first quarter of 2024 was EUR 2.3 million (USD 2.8 million), as compared to EUR 2.8 million (USD 3.0 million) for the first quarter of 2023. The decrease in LITHO revenue was driven by 2 lithotripsy units sold in the first quarter of 2024 as compared to 4 units sold in the first quarter of 2023.

 

Total revenue in the Distribution business for the first quarter of 2024 was EUR 6.9 million (USD 7.4 million), as compared to EUR 6.8 million (USD 7.3 million) for the first quarter of 2023. The increase in Distribution revenue was driven primarily by 11 ExactVu units sold during the first quarter of 2024 as compared to 8 units sold during the first quarter of 2023.

 

Gross profit for the first quarter of 2024 was EUR 6.4 million (USD 6.9 million), compared to EUR 6.0 million (USD 6.5 million) for the year-ago period. Gross profit margin on net sales was 42.8% in the first quarter of 2024, compared to 40.8% in the year-ago period. The increase in gross profit margin year-over-year was primarily due to the higher level of treatment driven revenues which generates higher gross margin.

 

Operating expenses were 11.2 million euros (12.1 million in US Dollars) for the first quarter, compared to 12.6 million euros (13.6 million in US Dollars) for the same period in 2023. The decrease in operating expenses was due to the recording in Q1 2023 of a one-time, non-recurring employee compensation expense. The impact from this one-time expense in Q1 2023 was offset by the continued investment in the Company’s U.S. commercial operations.

 

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Operating loss for the first quarter of 2024 was EUR 4.8 million (USD 5.2 million), compared to an operating loss of EUR 6.6 million (USD 7.1 million) in the first quarter of 2023.

 

Net loss for the first quarter of 2024 was EUR 4.5 million (USD 4.9 million), or EUR (0.12) per diluted share, as compared to net loss of EUR 7.5 million (USD 8.1 million), or EUR (0.20) per diluted share in the year-ago period.

 

Conference Call

 

A conference call and webcast to discuss the first quarter 2024 financial results will be hosted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, Chief Accounting Officer. Please refer to the information below for conference call dial-in information and webcast registration.

 

Date:Thursday, May 16th @ 8:30am Eastern Time

Domestic:1-877-451-6152

International:1-201-389-0879

Passcode (Conf ID):13745791

Call me™: https://callme.viavid.com/viavid/?callme=true&passcode=13712293&h=true&info=company-email&r=true&B=6

·Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event.

·Call me™ link will be made active 15 minutes prior to scheduled start time.

 

Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1665376&tp_key=00daa24457

 

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, us.hifu-prostate.com and www.focalone.com.

 

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. 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 risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.

 

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Other 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.

 

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.

 

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:
   March 31,  March 31,  March 31,  March 31,
   2024  2023  2024  2023
   Euros  Euros  $US  $US
Sales of medical equipment   9,967    10,319    10,782    11,121 
Net Sales of RPP and Leases   1,775    1,579    1,921    1,701 
Sales of spare parts, supplies and Services   3,165    2,897    3,424    3,123 
TOTAL NET SALES   14,908    14,795    16,127    15,945 
Other revenues   —    —    —    — 
TOTAL REVENUES   14,908    14,795    16,127    15,945 
Cost of sales   (8,523)   (8,764)   (9,220)   (9,445)
GROSS PROFIT   6,385    6,032    6,907    6,500 
Research & development expenses   (2,069)   (1,458)   (2,238)   (1,571)
S, G & A expenses   (9,132)   (11,130)   (9,879)   (11,995)
Total operating expenses   (11,201)   (12,588)   (12,117)   (13,566)
OPERATING PROFIT (LOSS)   (4,816)   (6,556)   (5,210)   (7,066)
Interest (expense) income, net   145    256    157    276 
Currency exchange gains (loss), net   236    (1,145)   255    (1,234)
INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST   (4,435)   (7,445)   (4,798)   (8,024)
Income tax (expense) credit   (111)   (46)   (120)   (49)
NET INCOME (LOSS)   (4,546)   (7,491)   (4,918)   (8,073)
Earning per share – Basic   (0.12)   (0.20)   (0.13)   (0.22)
Average number of shares used in computation of EPS   36,996,722    36,922,286    36,996,722    36,922,286 
Earning per share – Diluted   (0.12)   (0.20)   (0.13)   (0.22)
Average number of shares used in computation of EPS for positive net income   36,996,722    36,922,286    36,996,722    36,922,286 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2024 average three months’ noon buying rate of 1 Euro = 1.0818 USD, and 2023 average three months noon buying rate of 1 Euro = 1.0777 USD

 

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EDAP TMS S.A.

UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS

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

             
   March 31,  December 31,  March 31,  December 31,
   2024  2023  2024  2023
   Euros  Euros  $US  $US
Cash, cash equivalents and short-term treasury investments   38,441    43,471    41,482    48,087 
Account receivables, net   17,009    19,238    18,355    21,281 
Inventory   17,451    15,112    18,831    16,717 
Other current assets   1,189    659    1,283    729 
TOTAL CURRENT ASSETS   74,091    78,480    79,951    86,814 
Property, plant and equipment, net   10,106    8,193    10,906    9,063 
Goodwill   2,412    2,412    2,603    2,668 
Other non-current assets   2,469    2,464    2,665    2,725 
TOTAL ASSETS   89,078    91,548    96,124    101,270 
Accounts payable & other accrued liabilities   18,659    18,435    20,135    20,392 
Deferred revenues, current portion   4,123    4,049    4,449    4,479 
Short term borrowing   2,719    2,466    2,934    2,728 
Other current liabilities   2,791    2,646    3,012    2,927 
TOTAL CURRENT LIABILITIES   28,293    27,596    30,531    30,526 
Obligations under operating and finance leases non-current   2,498    1,315    2,696    1,454 
Long term debt, non-current   1,621    1,997    1,749    2,209 
Deferred revenues, non-current   598    643    645    712 
Other long term liabilities   3,081    3,075    3,325    3,402 
TOTAL LIABILITIES   36,091    34,626    38,946    38,304 
TOTAL SHAREHOLDERS’EQUITY   52,987    56,922    57,178    62,966 
TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY   89,078    91,548    96,124    101,270 

 

NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.0791 USD, on March 31, 2024 and at the noon buying rate of 1 Euro = 1.1062 USD, on December 31, 2023.

 

 

 

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EDAP TMS S.A.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Amounts in thousands of Euros)

             
   Three Months Ended  Twelve Months Ended  Three Months Ended  Twelve Months Ended
   March 31,  December 31,  March 31,  December 31,
   2024  2023  2024  2023
   (Euros)  (Euros)  ($US)  ($US)
NET INCOME (LOSS)   (4,546)   (21,178)   (4,918)   (22,930)
Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)   1,340    9,403    1,450    10,181 
OPERATING CASH FLOW   (3,206)   (11,775)   (3,468)   (12,749)
Increase/Decrease in operating assets and liabilities   (544)   (2,903)   (589)   (3,144)
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES   (3,750)   (14,678)   (4,057)   (15,892)
Short term investments   —    (0)   —    (0)
Additions to capitalized assets produced by the company and other capital expenditures   (1,098)   (4,344)   (1,188)   (4,704)
NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES   (1,098)   (4,344)   (1,188)   (4,704)
NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES   (167)   (911)   (181)   (986)
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS   (13)   268    (1,179)   2,130 
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS   (5,029)   (19,666)   (6,605)   (19,452)

 

(1) including share based compensation expenses for 692 thousand of Euros for the three months ended March 31, 2024 and 6,865 thousand of Euros for the full year ended December 31, 2023.

 

NOTE: Translated for convenience of the reader to U.S. dollars at the 2024 average three months’ noon buying rate of 1 Euro = 1.0818 USD, and 2023 average twelve months noon buying rate of 1 Euro = 1.0827 USD

 

 

 

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EDAP TMS S.A.

UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION

three months ended March 31, 2024

(Amounts in thousands of Euros)

                            
   HIFU     ESWL     Distribution     Reconciling  Total After   
   Division     Division     Division     Items  Consolidation   
Sales of goods   3,708        832        5,427        —    9,967     
Sales of RPPs & Leases   1,458        262        55        —    1,775     
Sales of spare parts & services   618        1,177        1,370        —    3,165     
TOTAL NET SALES   5,784        2,271        6,852        —    14,908     
Other revenues   —        —        —        —    —     
TOTAL REVENUES   5,784        2,271        6,852        —    14,908     
GROSS PROFIT (% of Net Sales)   3,003   51.9%   949   41.8%   2,433   35.5%   —    6,385   42.8%
Research & Development   (1,752)       (125)       (192)       —    (2,069)    
Total SG&A plus depreciation   (5,195)       (439)       (2,502)       (996)   (9,132)    
OPERATING PROFIT (LOSS)   (3,943)       384        (261)       (996)   (4,816)    

 

 

 

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