EDAP Q1 2026: record HIFU revenue $11.6M (+78% YoY); net loss $9.1M

EDAP TMS SA

2026-Q1 EPS reported -$0.24 revenue$17,812,000

HIFU revenue $11.6M, up 78% YoY; total revenue $17.8M vs $14.3M in Q1 2025.
Eleven Focal One systems sold (+83% YoY); U.S. HIFU procedures up 53% YoY.
Gross margin improved to 45.7% from 42.0% on favorable HIFU mix.
Reiterated FY 2026 HIFU revenue guidance $50-54M; non-core $22-26M.
HIFI-2 study in European Urology Oncology supports Focal One for salvage HIFU after radiation failure.

item 2.02 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.95

EDAP TMS SA reported the first quarter of 2026 results: revenue $17.8 million, net income $9.1 million, or ($0.24) per share, EPS ($0.24) per share. Guidance reaffirmed.

Period: the first quarter of 2026
Revenue: $17.8 million
Net income: $9.1 million, or ($0.24) per share
EPS: ($0.24) per share
Guidance: reaffirmed
Result: reported results

Exact text from the filing

focus on the high-growth, high margin opportunity in focal therapy through its Focal One Robotic HIFU platform. Company Total worldwide revenue for the first quarter of 2026 was $17.8 million, compared to $14.3 million for the same period in 2025. Gross profit margin on net sales was 45.7%, up from 42.0% for the same period in 2025. The margin improvement was

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Source: SEC EDGAR

accession 0001171843-26-003113

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