EDAP TMS SA: Strong Q2 HIFU Growth & Credit Facility LOI

TL;DR

EDAP TMS SA crushed Q2 with 140% Focal One growth and 76.8% HIFU revenue jump, plus a 36M Euro credit facility LOI.

AI Summary

EDAP TMS SA reported strong second quarter 2025 results, with a 140% year-over-year increase in Focal One® net placements and a 76.8% year-over-year increase in HIFU revenue, reaching 36 million Euros. The company also announced a Letter of Intent for a credit facility.

Why It Matters

The significant growth in HIFU revenue and placements indicates strong market adoption of EDAP's technology, while the credit facility provides financial flexibility for future operations and expansion.

Risk Assessment

Risk Level: medium — While the results are positive, the company is still in a growth phase and relies on market adoption of its specialized medical technology.

Key Numbers

• +140% — Focal One® Net Placement Growth (Significant year-over-year increase indicating strong market adoption)
• +76.8% — HIFU Revenue Growth (Substantial year-over-year increase in revenue from HIFU technology)
• 36 million Euro — Credit Facility Letter of Intent (Indicates potential for increased financial flexibility)

Key Players & Entities

• EDAP TMS SA (company) — Registrant and reporting company
• Focal One® (product) — Key product driving placement growth
• HIFU (technology) — High-Intensity Focused Ultrasound technology driving revenue growth
• Ken Moebck (person) — Chief Financial Officer signing the report
• 36 million Euro (dollar_amount) — Amount of the credit facility Letter of Intent

FAQ

Filing Documents

• f6k_082825.htm (6-K) — 226KB
• 0001171843-25-005622.txt ( ) — 227KB

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: August 28, 2025 EDAP TMS S.A. /s/ KEN MOBECK KEN MOBECK CHIEF FINANCIAL OFFICER 2 EDAP Reports Strong Second Quarter 2025 HIFU Results · +140% Focal One ® Net Placement Growth Year over Year · +76.8% HIFU Revenue Growth Year over Year · 36 million Euro Credit Facility Letter of Intent Executed with European Investment Bank (EIB) to further accelerate HIFU Growth and Strategic Expansion · Company raises 2025 HIFU Year over Year Revenue Growth Guidance range to 26% to 34%, up from the prior range of 16% to 25% Company to Host Conference Call and Webcast Today, August 28th, at 8:30 a.m. EDT AUSTIN, Texas, August 28, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, reported today unaudited consolidated financial results for the second quarter of 2025. “We experienced our strongest second quarter performance in our company’s history, placing a net total of 12 Focal One Robotic HIFU Systems with increased customer demand coming from both U.S. and international markets,” said Ryan Rhodes, Chief Executive Officer. “The strong year over year growth in the second quarter underscores the accelerating momentum of our leading Focal One platform and its increased adoption amongst urologists. To continue to advance the expansion of Focal One, including new indications and further development of focused ultrasound technologies, we executed a letter of intent with the European Investment Bank that will provide a significant source of low interest rate capital. As we enter the second half of 2025, our Focal One pipeline continues to strengthen, and we anticipate demand for Focal One continuing to grow as more prostate cancer patients recognize the advantages of the Focal

Forward-looking statements speak only as of

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 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: June 30, June 30, June 30, June 30, 2025 2024 2025 2024 Euros Euros $US $US Sales of medical equipment 11,221 11,118 12,891 11,948 Net sales of RPP and leases 2,246 1,886 2,580 2,027 Sales of spare parts, supplies and services 2,576 2,787 2,960 2,995 TOTAL REVENUES 16,043 15,791 18,431 16,970 Cost of sales (9,221 ) (9,872 ) (10,594 ) (10,609 ) GROSS PROFIT 6,822 5,919 7,838 6,361 Research & development expenses (2,208 ) (2,077 ) (2,537 ) (2,232 ) Selling, general & administrative expenses (10,382 ) (9,989 ) (11,928 ) (10,736 ) Total operating expenses (12,591 ) (12,066 ) (14,465 ) (12,967 ) OPERATING LOSS (5,769 ) (6,147 ) (6,628 ) (6,606 ) Interest (expense) income, net (57 ) 190 (66 ) 204 Currency exchange gains (loss), net 319 (49 ) 367 (52 ) LOSS BEFORE INCOME TAXES (5,507 ) (6,005 ) (6,327 ) (6,454 ) Income tax (expense) credit, net (93 ) (127 ) (107 ) (136 ) NET LOSS (5,600 ) (6,132 ) (6,434 ) (6,590 ) Earning per share – basic and diluted (0.15 ) (0.16 ) (

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View this 6-K filing on SEC EDGAR