EDAP TMS S.A. Files Form 6-K

TL;DR

EDAP TMS S.A. filed a 6-K on 5/16/24. CFO signed off.

AI Summary

EDAP TMS S.A. filed a Form 6-K on May 16, 2024, to report its financial information. The filing indicates the company is a foreign private issuer and is submitting its report under the Securities Exchange Act of 1934. Ken Mobek, the Chief Financial Officer, signed the report.

Why It Matters

This filing provides an update on EDAP TMS S.A.'s regulatory reporting status, which is important for investors to stay informed about the company's compliance and financial disclosures.

Risk Assessment

Risk Level: low — This is a routine regulatory filing (Form 6-K) that does not contain new material financial or operational information, but rather confirms reporting status.

Key Players & Entities

• EDAP TMS S.A. (company) — Registrant
• Ken Mobek (person) — Chief Financial Officer
• May 16, 2024 (date) — Filing Date

FAQ

Key Financial Figures

• $6.3 million — 1 2024 HIFU revenue of EUR 5.8 million ($6.3 million USD), an increase of 10.2% over Q1 2023
• $16.1 million — 2024 total revenue of EUR 14.9 million ($16.1 million USD) increased 0.8% over Q1 2023 - Co

Filing Documents

• f6k_051624.htm (6-K) — 147KB
• logo.jpg (GRAPHIC) — 4KB
• 0001171843-24-002928.txt ( ) — 154KB

SIGNATURES

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 expec

Forward-Looking Statements

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 d

Forward-looking statements speak only as of the

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,

View Full Filing

View this 6-K filing on SEC EDGAR