EDAP TMS SA Q3 Revenue Up 11.6%, HIFU Revenue Surges 48.2%

TL;DR

EDAP TMS Q3 revenue up 11.6% to $14.4M, HIFU revenue exploded 48.2% to $4.9M!

AI Summary

EDAP TMS SA reported third quarter 2024 financial results on November 7, 2024. The company announced worldwide revenue of EUR 13.1 million (USD 14.4 million), an 11.6% increase compared to Q3 2023. Notably, worldwide HIFU revenue grew significantly by 48.2% to EUR 4.5 million (USD 4.9 million) in the same period.

Why It Matters

The strong growth in HIFU revenue indicates increasing adoption and market traction for EDAP's high-intensity focused ultrasound technology, potentially signaling future profitability and market leadership.

Risk Assessment

Risk Level: medium — While the results are positive, the company operates in a specialized medical device market with regulatory hurdles and competition, which could impact future performance.

Key Numbers

• 11.6% — Q3 Worldwide Revenue Growth (Indicates overall business expansion compared to the prior year.)
• 48.2% — Q3 Worldwide HIFU Revenue Growth (Highlights significant market adoption and success of their core technology.)
• EUR 13.1 million — Q3 Worldwide Revenue (Total revenue generated in the third quarter.)
• EUR 4.5 million — Q3 Worldwide HIFU Revenue (Revenue specifically from their High-Intensity Focused Ultrasound business.)

Key Players & Entities

• EDAP TMS SA (company) — Filer of the report and subject of the financial results
• EUR 13.1 million (dollar_amount) — Reported Q3 worldwide revenue
• USD 14.4 million (dollar_amount) — Reported Q3 worldwide revenue in USD equivalent
• Q3 2023 (date) — Comparison period for Q3 2024 revenue growth
• EUR 4.5 million (dollar_amount) — Reported Q3 worldwide HIFU revenue
• USD 4.9 million (dollar_amount) — Reported Q3 worldwide HIFU revenue in USD equivalent
• KEN MOBECK (person) — Chief Financial Officer who signed the report

FAQ

Key Financial Figures

• $9,247 — ing a Medicare Hospital payment rate of $9,247 as a national average, adjusted locally
• $15 billion — ity and debt transactions, raising over $15 billion in aggregate. Clinical Pipeline Updat

Filing Documents

• f6k_110724.htm (6-K) — 178KB
• logo.jpg (GRAPHIC) — 4KB
• 0001171843-24-006087.txt ( ) — 185KB

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: November 7, 2024 EDAP TMS S.A. /s/ KEN MOBECK KEN MOBECK CHIEF FINANCIAL OFFICER EDAP Reports Third Quarter 2024 Financial Results - Reported Q3 worldwide revenue of EUR 13.1 million (USD 14.4 million), increasing 11.6% over Q3 2023 - Reported Q3 worldwide HIFU revenue of EUR 4.5 million (USD 4.9 million), increasing 48.2% over Q3 2023 - 34% year-over-year growth in U.S. Focal One HIFU procedures - CMS increases Medicare Hospital Outpatient Focal One HIFU procedure payment by 5.4% for 2025 - Announced AI collaboration with Avenda Health for Focal One Robotic HIFU - Company to host conference call and webcast today, November 7th, at 8:30 a.m. EDT LYON, France, November 7, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the third quarter of 2024. “We continued to make steady progress in growing our core Focal One business in the third quarter of 2024,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “HIFU revenue grew 48.2% on a year-over-year basis, reflecting strong growth in the number of Focal One procedures. As we continue to expand our innovation with the Focal One platform, we are now partnering with Avenda Health to introduce AI technology directly into the Focal One robotic system. During the quarter, EDAP also had strong engagement through numerous interactions with urology leaders across multiple scientific meetings around the world. “Our clinical programs in benign prostatic hyperplasia (BPH) and endometriosis also continue to make important progress. We recently announced that the first patients were treated in our Phase I/II study evaluating Focal One Robotic HIFU for the treatment of BPH. We also continue to se

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. 5 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 6 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: September 30, September 30, September 30, September 30, 2024 2023 2024 2023 Euros Euros $US $US Sales of medical equipment 8,393 7,190 9,240 7,775 Net sales of RPP and leases 1,586 1,236 1,746 1,336 Sales of spare parts, supplies and services 3,120 3,311 3,435 3,581 TOTAL REVENUE 13,098 11,737 14,420 12,692 Cost of sales (7,944 ) (7,574 ) (8,746 ) (8,191 ) GROSS PROFIT 5,154 4,162 5,675 4,501 Research & development expenses (1,716 ) (1,628 ) (1,889 ) (1,761 ) Selling, general & administrative expenses (9,271 ) (8,086 ) (10,207 ) (8,745 ) Total operating expenses (10,987 ) (9,714 ) (12,096 ) (10,505 ) OPERATING LOSS (5,833 ) (5,552 ) (6,422 ) (6,004 ) Interest (expense) income, net 102 347 113 376 Currency exchange gains (loss), net (606 ) 1,303 (667 ) 1,409 LOSS BEFORE INCOME TAXES (6,337 ) (3,901 ) (6,976 ) (4,219 ) Income tax (expense) credit, net (62 ) (45 ) (69 ) (49 ) NET LOSS (6,399 ) (3,946 ) (7,045 ) (4,268 ) Loss per share – Basic and diluted (0.17 ) (0.11 ) (

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