Smaio: Operating expenses up 15%, half-year EBITDA falls to -0.8 M€
Smaio published half-yearly accounts on October 13, 2026, marked by a 15% increase in operating expenses, which brought EBITDA to -0.8 M€ compared to -0.03 M€ a year earlier. At the same time, revenue absorbed the decline in activity from four historical surgeons in the United States, offset by the arrival of new users.
The specialist in complex spinal surgery, listed on Euronext Growth Paris, recorded revenue of 7.2 M€ in the first nine months of 2026, up 2%. This near-stability masks a change in the composition of its American customer base. The four surgeons who represented more than half of American sales in the first nine months of 2025 generated 2.2 M$ this year, compared to 3.5 M$ a year earlier.
Half-year revenue up 3%, operating loss of 1.7 M€
In the first half of 2026, revenue reached 5.1 M€ compared to 5.0 M€, up 3% (8% excluding currency effects). Sales of implants in the United States, which now represent more than 80% of the group's sales, stood at 3.9 M€ compared to 3.8 M€.
The gross margin rate fell to 81%, compared to 85% in the first half of 2025, a decline of 4 percentage points, and gross profit fell from 4.3 M€ to 4.2 M€. The company attributes this evolution to the strengthening, in the second half of 2025, of its patient-specific rod production unit, which underpins its strategy for penetrating the American market.
Operating expenses increased by 15% to 5.9 M€. The operating result came to -1.7 M€ compared to -0.9 M€, and the net result attributable to the group fell to -1.2 M€ compared to -0.7 M€, after a financial result of 0.1 M€ and a tax benefit of 0.4 M€, including 0.2 M€ in research tax credit. These figures are unaudited.
American customer base expands and offsets the decline of four historical accounts
The increase in expenses reflects, according to the company, its investments in two areas: R&D, with the completion of the final stages before the market launch of cobalt-chromium rods and the development of surgeon assistance applications, as well as the training and engagement of a network of expert surgeons.
On the commercial side, the third quarter illustrates the change in customer composition. The group's revenue remained stable at 2.0 M€, while implant sales in the United States declined to 1.8 M$ (1.6 M€) compared to 2 M$ a year earlier. According to Smaio, three historical surgeons reduced their activity after relocating to new centers at the beginning of the year, and the fourth for personal reasons.
Over nine months, approximately thirty surgeons used the company's custom rods through its open platform, for more than 80 procedures and over 260,000 dollars, compared to approximately 100,000 dollars in 2025. A dozen new surgeons adopted the complete offering, generating more than 0.9 M$, and existing customer activity increased by nearly 27%, to 3.0 M$ compared to 2.4 M$.
In dollars, North American sales increased by 4% to 6.4 M$. Converted into euros, they reach 5.5 M€, with the change in exchange rates having an impact of -0.2 M€ over the period.
Cash position of 7.0 M€ following a capital increase of 3.6 M€
As of June 30, 2026, Smaio had a cash position of 7.0 M€, compared to 5.9 M€ as of December 31, 2025. This level includes the capital increase of 3.6 M€ carried out in March 2026 with Eiffel Investment Group, through the issuance of shares with share purchase warrants at the price of 7 € per share. If all warrants are exercised, at the price of 7.3 € per share, the total amount of the issuance could reach 4.5 M€.
For the coming quarters, the company is relying on the distribution agreement signed on October 6, 2026 with DePuy Synthes, the third industrial partnership around its open platform KEOPS-4ME following Orthofix and Highridge. It reports observing a gradual resumption of procedures following registrations completed in two of the three new centers where the historical surgeons relocated, and expects registration for the third in early 2027.
Management anticipates, on the other hand, an inability to operate for the fourth surgeon in the coming months, as well as a ramp-up of other surgeons working in the same center. In the United States, the group now relies on approximately forty surgeons, supplemented by users of the open platform.
