Key events in 2025
- Clinical evidence was strengthened:
- Award at EAU 2025 for a study of >1,000 men in Germany, Switzerland and Turkey, among other countries, which showed better precision vs PSA screening.
- Article in Journal of Urology (SEPTA cohort, multi-ethnic US data) supporting Stockholm3 compared with other biomarkers/risk calculators.
- Nine-year follow-up published in European Urology (October): Stockholm3 identifies aggressive/potentially lethal cancer even at PSA 1.5–3 ng/ml; men with a positive Stockholm3 result in that range had a much higher risk (hazard ratio 8.8) of high-risk biochemical recurrence after treatment.
- The US track intensified:
- First guiding pre-submission meeting with the FDA in October ahead of a possible PMA process.
- In parallel: preparations for CMS/Medicare reimbursement and a plan for a pivotal study in the US.
- Market/commercial:
- Sweden: revenue was driven largely by project-based volume (the Reinvite study + Region Värmland), which shows that stable clinical demand and reimbursement models are still key issues.
- Switzerland: measures to reduce reimbursement uncertainty and lower the thresholds for use.
- Germany: a more focused “region-by-region” strategy starting in Munich (university hospital).
- United Kingdom: increased demand even though public funding is lacking (patients pay themselves).
Financial performance (group)
Revenue
- Net sales: 18.5 MSEK (15.6) → +18%. Driven mainly by the Reinvite study and Värmland.
Earnings
- Gross profit: 2.4 MSEK (-0.4) → improvement due to more tests and a lower average cost/materials.
- Operating profit: -82.8 MSEK (-79.1).
- Profit before tax: -78.8 MSEK (-70.8).
- Costs in brief:
- Selling expenses: 32.1 MSEK (23.2) ↑ (mainly US regulatory/market + higher activity in Germany).
- Administrative expenses: 22.7 MSEK (25.2) ↓ (fewer admin staff + 2024 had a larger restructuring provision).
- R&D: 34.1 MSEK (33.0) ≈ unchanged.
Cash flow & liquidity
- Cash flow from operating activities: -69.2 MSEK (-64.6).
- Cash and cash equivalents + short-term investments at year-end: 156.6 MSEK (229.7).
- The group has no interest-bearing liabilities.
Balance sheet
- Equity: 156.1 MSEK (227.4).
- Equity ratio: 84.2% (88.7) – still high, but falling as losses accumulate.
- Number of employees at year-end: 33 (31).
Regulatory and quality
- Two quality systems: one under ISO 13485 and other standards for medical technology, and one for the laboratory under Swedish requirements.
- The products are CE marked under the IVD Directive and are classed as “legacy products” under the IVDR.
- Full IVDR compliance/CE marking under the IVDR is required before December 2028 for continued EU sales; implementation is reported to be on schedule.
Owners and incentives
- 50,922,362 shares. The 10 largest owners control 84.57% of capital/votes.
- Five option programmes active; on full exercise of four of them, total dilution of 6.9% is stated (QESO 2022 is stated to have no real value, “out-of-the-money”).
The board's view of the year
2025 is described as a year of major scientific and strategic progress, but also of lessons about commercialisation in markets with complex reimbursement. With a strong balance sheet and a clearer focus, the company enters 2026 with the aim of turning evidence and strategy into increased clinical use and more sustainable demand.
Read more about A3P Biomedical's share.
