BioPorto (BIOPOR) Status Update summary

Strategic focus and market opportunity

• Launched a three-year strategy to drive adoption and usage of kidney health biomarkers, focusing on acute kidney injury (AKI) and expanding into new patient segments and clinical settings.

• Ambition to become cashflow positive in H2 2027 and reach DKK 150–200 million in revenue by 2028, with an EBITDA margin target of at least 15%.

• FDA approval for pediatric use achieved; adult market entry targeted for 2027 following ongoing studies and pre-submission dialogue with the FDA.

• Anticipation of updated clinical guidelines in 2026 to support broader market access and adoption.

• Market potential estimated at DKK 700 million, with a focus on intensive care AKI cases and expansion through partnerships.

Commercial execution and sales development

• US hospital adoption is increasing, aiming for over 60 active hospitals by 2026 and 100+ globally by 2027, supported by research use and clinical validation.

• Commercial strategy in Europe targets key markets, leveraging US experience and aiming for EU IVDR certification in 2027.

• Sales process includes hospital validation, staff training, and demonstrating health economic benefits.

• US RUO sales grew 20% in Q3 (27% currency-adjusted), with a 24% rolling 12-month growth, while rest of world sales are volatile.

• Strategic partnerships with instrument manufacturers are key to accelerating product adoption in laboratories.

Financial performance and guidance

• Q3 revenue was DKK 10.4 million, up 7% (10% currency-adjusted); adjusted EBITDA loss was DKK 16.8 million, a 14% improvement.

• 2025 revenue guidance revised to DKK 40–45 million; EBITDA loss guidance unchanged at DKK 75–80 million.

• Funding need of DKK 60–70 million identified to reach cashflow positivity, with options including equity, loans, and potential divestment of the antibody business.

• Management expects to announce funding process and timeline soon; both CEO and CFO intend to participate in any equity raise.

• Updated aspirations replace previous targets, extending the timeline for cash flow positivity and revenue milestones.