FOCLNasdaqElectromedical & Electrotherapeutic ApparatusUS GAAP · USD

Edap TMS SA

EDAP TMS SA develops and commercializes minimally invasive medical systems, centered on its Focal One robotic high-intensity focused ultrasound (HIFU) platform for prostate care. The company also has legacy lithotripsy (ESWL) and medical device distribution activities, with operations and sales across the United States, Europe, and other international markets.

Kysy yhtiöstä
Liikevaihto70,5milj. USD
+10,0 %v/v
Liikevoitto (EBIT)−24,7milj. USD
−20,3 %v/v
EBIT-marginaali−35,0%
−3,0 %-yks.v/v
Nettotulos−29,2milj. USD
−53,8 %v/v
Vapaa kassavirta−17,6milj. USD
−18,3 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2020–2025

−40−20020406080milj. USD2020: 42 milj. USD2020: EBIT 0,27 milj. USD20202021: 44 milj. USD2021: EBIT −1,6 milj. USD20212022: 55 milj. USD2022: EBIT −4,3 milj. USD20222023: 60 milj. USD2023: EBIT −20 milj. USD20232024: 64 milj. USD2024: EBIT −21 milj. USD20242025: 71 milj. USD2025: EBIT −25 milj. USD202571−25
LiikevaihtoLiikevoitto (EBIT)
Kysy Clarifolta: Edap TMS SA

Liiketoiminta

Osuus liikevaihdosta
HIFU systems and treatment revenue65 %

Robotic HIFU systems, disposables, RPP arrangements, leases, and related services.

HIFU maintenance and installed-base services7 %

Maintenance contracts and support services for installed Focal One systems.

ESWL products and services8 %

Legacy lithotripsy consumables, spare parts, repair services, and residual system activity.

Distribution services20 %

Third-party medical device distribution and related consumables, leasing, and services.

Tuotteet

Raportoitu · osuus liikevaihdosta
69,3%16,1%14,6%FY2025100 %
  • Manufactured Product Other69,3 %
  • Parts and Services16,1 %
  • HIFU Treatments and Devices Leased14,6 %

Lähde: 10-K FY2025, yhtiön tuotelinjoittain raportoima liikevaihto (SEC XBRL). Osuudet on laskettu näytetyistä riveistä ja ne summautuvat 100 %:iin.

Asiakkaat

EDAP sells primarily to hospitals, urology centers, and other healthcare providers that treat prostate and stone disease. Its HIFU business serves providers that want a robotic, minimally invasive therapy platform, while the RPP and lease models appeal to customers that prefer usage-based or lower upfront payment structures. The ESWL and distribution businesses serve installed-base users and healthcare buyers needing consumables, parts, and third-party devices.

Hospitals and academic medical centers

Buy Focal One systems and related services to add minimally invasive prostate treatment capability.

Urology clinics and treatment centers

Use RPP and lease arrangements to access HIFU technology with lower upfront capital needs.

Installed-base ESWL customers

Purchase consumables, spare parts, and repairs for existing lithotripsy systems.

Medical device distribution customers

Buy third-party devices and related consumables through the distribution channel.

Strategia

EDAP’s strategy is centered on expanding its proprietary HIFU franchise and reducing reliance on legacy ESWL and distribution activities. The company is building installed base, treatment-driven revenue, and recurring service streams while continuing to invest in commercialization and product development. This mix is intended to strengthen the long-term profile of the business around a differentiated medical technology platform.

Expand HIFU commercializationLyhyt aikaväli

HIFU is the core proprietary platform and the main driver of future growth.

Build recurring revenue streamsKeskipitkä aikaväli

RPP, leases, disposables, and maintenance reduce dependence on one-time equipment sales.

Reduce reliance on legacy businessesKeskipitkä aikaväli

ESWL and distribution are lower-priority activities and less central to the company’s platform strategy.

Maantiede

Q2/2026

EDAP has a multinational footprint, with meaningful activity in the United States and Europe and additional sales in other jurisdictions. The company uses different commercial models by region, including operating leases in the U.S. and RPP arrangements in Europe, which affects revenue timing and predictability. Its installed base and sales mix also create exposure to local reimbursement, regulatory, and adoption patterns in each market.

USA63 %
Other countries (US filing)26 %
Ranska10 %
Asia0,9 %

Osuus liikevaihdosta, jonka yhtiö raportoi maantieteellisesti.

Riskit

EDAP depends on adoption of a specialized medical technology, so demand can be affected by hospital capital budgets, clinical acceptance, and reimbursement dynamics. The business also faces execution risk from its mix of equipment sales, leases, RPP contracts, and recurring service revenue, plus exposure to foreign exchange, tariffs, and regulatory requirements across markets.

Järjestetty vakavuuden mukaan
Dependence on HIFU adoptionKorkea

The growth strategy relies on hospitals and clinics adopting Focal One and treatment workflows.

Kohdistuu: U.S. and Europe commercialization

Financing and dilution riskKorkea

Commercialization and R&D needs may require additional capital if operating cash generation is insufficient.

Kohdistuu: Corporate funding

Legacy business declineKeskitaso

ESWL system sales have ended and distribution agreements have been terminated, reducing legacy revenue streams.

Kohdistuu: ESWL and Distribution divisions

Revenue timing from leases and RPP contractsKeskitaso

Operating leases and revenue-per-procedure models spread revenue over time and can create quarter-to-quarter volatility.

Kohdistuu: HIFU division

Foreign exchange and tariff exposureKeskitaso

The company operates internationally and has disclosed tariff impact and euro-dollar sensitivity.

Kohdistuu: Europe and cross-border supply chain

Kysy Clarifolta: Edap TMS SA

Kirjanpito

Harkinnanvaraiset erät
Revenue recognition by business model

Focal One sales, leases, RPP, disposables, and services are recognized differently and affect timing of revenue.

Vaikutus: Can shift revenue between quarters and change gross margin mix

Fair value of warrants and debt-related instruments

The company records fair value changes on EIB warrants and related financing items.

Vaikutus: Can create volatility in non-operating income or expense

Foreign currency translation and transaction effects

International operations expose the company to euro-dollar and other currency movements.

Vaikutus: Can materially affect reported earnings and cash balances

Lease accounting and installed-base arrangements

Operating leases for Focal One systems affect revenue timing and asset/liability presentation.

Vaikutus: Influences balance sheet structure and recurring revenue profile

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Julkisesti listattuja yhtiöitä, joilla on samankaltainen liiketoiminta.

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Päivitetty: 24.9.2026