Analyst Comment

BioPorto: Strong end to 2025, guidance points to continued momentum in 2026

BioPorto yesterday, after market close, delivered preliminary 2025 figures, set new 2026 guidance, confirmed the mid-term targets set out in the new "Forward" strategy, and updated on business development and expected regulatory timeline.

Q4 2025 showed revenue of DKK 11.6m, up 47% YoY (52% at constant exchange rates), marking the strongest quarter of the year. The growth was driven by continued momentum in U.S. NGAL RUO sales and a larger bulk order from strategic distributors.

For the full year 2025, revenue reached DKK 40.3m, up 11% YoY (13% at constant exchange rates), landing within the guided range of DKK 40-45m. Total NGAL revenue grew 22% to DKK 28.2m, now representing 70% of total revenue, with U.S. NGAL RUO growing 25% to DKK 18.4m.

Adjusted EBITDA came in at approximately DKK -77m, within the DKK -75 to -80m guidance. Cash position at year-end stood at approximately DKK 55m.

Importantly, BioPorto introduced financial guidance for 2026, which was not provided when the "Forward" strategy was first announced in November 2025. The company is targeting total revenue of DKK 48-58m (20-45% growth), with NGAL revenue expected to reach DKK 33-42m (20-50% growth). Adjusted EBITDA loss is guided to narrow to DKK 50-60m, representing a 22-35% improvement driven by higher revenues and cost reductions. Management reiterates the target of 60+ active U.S. hospitals by end of 2026, up from 44 at end of 2025.

On the regulatory front, the adult cut-off study database lock is expected in Q1 2026, followed by a pre-submission to the FDA by end of Q1 2026. The validation study is anticipated to run through 2026 and into H1 2027, with final FDA submission still expected by end of H1 2027.

Long-term aspirations remain unchanged: revenue of DKK 150-200m by 2028, adjusted EBITDA margin of at least 15%, and cash flow positive in H2 2027. Current cash is expected to cover operations through 2026, with management maturing financing options including potential non-core asset divestments and credit facilities.

Overall, the preliminary results demonstrate solid execution on the "Forward" strategy, with Q4 providing a strong finish to the year. The introduction of 2026 guidance adds visibility to the near-term trajectory, while the narrowing EBITDA loss signals improving operational leverage. Key catalysts for 2026 include commercial hospital adoption progress and the FDA pre-submission milestone.

We will host an event today with the management where we will take a deeper look at the results, guidance and the business update.

Bioporto - Event

Disclaimer: HC Andersen Capital receives payment from BioPorto for a DigitalIR/Corporate visibility agreement / Michael Friis 07:00 06/02/2026

BioPorto is a Danish in-vitro diagnostics company with headquarters in Copenhagen, Denmark. The company was founded in 2000. BioPorto has one marketed product, the NGAL test, for early diagnosis of acute kidney injury (AKI), which is commercially available in Europe, Canada, Asia, and Israel. It has received breakthrough designation from the FDA for AKI in the pediatric indication, for which it is currently conducting data analysis following the completion of enrollment of patients for its Phase 3 study which will lead to an expected application to FDA. Future plans include further FDA submission for adult indication as well as other markets.