EDAP TMS Earnings Call Transcripts
Fiscal Year 2026
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Record Q1 revenue of $17.8M was driven by 78% HIFU growth and strong global demand, with U.S. procedure volumes up 53% year-over-year. Guidance for 2026 was reiterated, and the company is expanding clinical indications and global reach.
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Focal One robotic HIFU is rapidly gaining adoption for prostate cancer, offering organ-preserving, highly efficacious treatment with superior functional outcomes compared to surgery and radiation. The technology is expanding into BPH and endometriosis, supported by strong clinical evidence and favorable reimbursement.
Fiscal Year 2025
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Core HIFU revenue grew 39% in 2025, driven by record Focal One placements and strong U.S. adoption, while total revenue declined 3% due to non-core business wind-down. 2026 guidance projects 34%-45% HIFU growth, with continued focus on cash sales and innovation.
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Strategic capital investments in focal therapy are accelerating, driven by strong clinical evidence, growing reimbursement, and expanding indications. HIFU is the core growth engine, with margin improvements expected from new platforms and operational efficiencies.
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Focal One i, an advanced robotic HIFU platform, is driving growth in prostate cancer treatment with strong clinical data and expanding adoption. New studies target BPH and endometriosis, while a focus on high-margin HIFU business is improving financial performance.
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Record Q3 2025 revenue driven by strong HIFU growth and expanding clinical adoption, with improved gross margin and reduced net loss year-over-year. Guidance for 2025 is maintained, supported by new financing and continued innovation in core business areas.
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A strategic pivot to focus solely on HIFU has driven rapid revenue growth and major hospital adoption, supported by strong clinical data and expanding indications. Upcoming reimbursement increases and a €36 million credit facility position the business for further expansion in 2025 and beyond.
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Record Q2 HIFU revenue and system placements drove strong growth, with improved gross margin and raised 2025 guidance. Expansion into new clinical indications and a €36M financing facility position the company for continued momentum.
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Focal One robotic HIFU is driving a shift in prostate cancer treatment, supported by robust clinical evidence and growing demand for non-invasive, function-preserving therapies. The company is focusing exclusively on HIFU, expanding indications, and rapidly increasing its install base in top U.S. centers.
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Record Focal One placements and HIFU revenue growth highlight a strategic shift toward core therapeutic markets, despite overall revenue decline and increased losses due to non-core segment contraction and higher investments. Positive clinical milestones and new product launches support strong 2025 guidance.
Fiscal Year 2024
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Record 2024 revenue was driven by robust HIFU growth and expanding Focal One adoption, with strong procedure volume increases and new regulatory milestones. Guidance for 2025 anticipates 16%-25% HIFU revenue growth, while non-core businesses are set to decline.
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Sales cycles for capital equipment have lengthened due to hospital diligence and macro factors, but reimbursement is improving and commercial payer coverage is expanding. The HIFI study supports broader adoption, and international growth is targeted. 2025 is expected to be transformative.
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Focal therapy and HIFU are rapidly gaining traction in prostate cancer treatment, supported by robust clinical evidence and favorable reimbursement trends. Expansion into BPH and endometriosis, along with strong financial growth and a leading hospital install base, position the technology for significant future adoption.
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Revenue grew 11.6% year-over-year, led by 48.2% HIFU growth and strong U.S. procedure adoption. Gross margin improved to 39.4%, but net loss widened due to higher operating expenses and investments. Favorable reimbursement and new AI collaborations support continued growth.
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The presentation highlighted global expansion, regulatory milestones, and rapid adoption of HIFU technology for prostate cancer and other conditions. Strong reimbursement, robust clinical evidence, and ongoing studies in BPH and endometriosis support continued growth.
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Q2 2024 saw record revenue growth of 10.6% year-over-year, driven by strong U.S. Focal One HIFU adoption and key placements at major cancer centers. Gross margin declined due to product mix, but cost improvements and a robust sales pipeline are expected to boost results in the second half.