SMAIO (ALSMA) H1 2026 & Q3 2026 TU earnings summary

Executive summary

• H1 2026 revenue rose 3% YoY to €5.134m; 9M revenue increased 2% to €7.2m, supported by U.S. expansion and a broader surgeon base.

• Higher commercial, staffing and R&D costs widened H1 operating loss to €1.692m and net loss to €1.248m.

• U.S. sales accounted for 76% of H1 revenue; partnerships with Highridge Medical, Orthofix and DePuy Synthes support wider hospital access.

Financial highlights

• H1 revenue was €5.134m versus €4.997m; gross profit was €4.161m versus €4.259m, and gross margin was 81% versus 85%.

• Operating expenses rose 15% to €5.9m; operating loss was €1.692m versus €0.942m, and net loss was €1.248m versus €0.728m.

• EBITDA after R&D tax credit was -€0.803m versus -€0.027m; expenses included higher commissions, payroll, R&D depreciation and surgeon-network development.

• Financial result was positive €53.5k versus a €68.1k loss; income tax benefit was €390.3k, mainly from R&D credits and deferred tax.

Outlook and guidance

• Priorities include expanding i-Kontrol sales in Europe, the U.S. and Australia, scaling KEOPS-4ME partnerships, and advancing KEOPS-data and AI-based R&D.

• Commercial targets include 15–20 active i-Kontrol U.S. centers in 2026 and 5–10 new centers annually in 2027–2030, with 100+ active centers planned.

• Product roadmap includes new implant options, augmented-reality support, sterile implant delivery, and planning-software and surgeon-assistance features.

• A third new U.S. center registration was anticipated in early 2027; October and December 2026 Sagittal Alignment Academy programs were planned in Australia and New York.