SMAIO (ALSMA) H1 2025 earnings summary

Executive summary

• Revenue for H1 2025 reached €5.0M, up 126% year-over-year, with 75% of sales from the US market, driven by strong US implant sales.

• Gross margin improved to 85% from 64% in H1 2024, reflecting higher-margin US sales.

• Operating loss narrowed to €0.9M from €1.7M year-over-year; net loss reduced to €0.7M.

• EBITDA improved by 96%, reaching near break-even at -€0.03M, compared to a loss of €0.6M in H1 2024.

• Solid cash position of €4.7M as of June 30, 2025, supporting ongoing growth and R&D investments.

Financial highlights

• Revenue: €5.0M (H1 2025) vs €2.2M (H1 2024), +126% year-over-year.

• Gross margin: 85% (H1 2025) vs 64% (H1 2024), up 21 points.

• EBITDA: (€27K) vs (€637K) year-over-year; nearly break-even at -€0.03M.

• Net loss: (€728K) vs (€1.2M) year-over-year.

• Cash and equivalents: €4.7M at June 30, 2025.

Outlook and guidance

• Focus on expanding i-kontrol commercialization in Europe, US, and Australia, and ramping up US commercial presence targeting 20 user centers by end of 2026.

• Continued R&D investment, especially in AI-driven planning and custom implants.

• KEOPS-4ME platform rollout through new partnerships, expected to contribute to sales and margins from Q2 2026.

• New US distribution partnership with Highridge Medical; first joint sales expected in early 2026.