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Analytikerkommentar

BioPorto Q3 2025 - Solid US NGAL test growth, and focus on new strategy

Af Philip CoombesEquity Research Analyst
BioPorto

BioPorto delivered Q3 revenue of DKK 10.4m, up 7% YoY, driven primarily by U.S. NGAL Research Use Only (RUO) sales growth, which increased 20% in the quarter. Q3 2025 also saw the first U.S. distributor order of ProNephro AKI™ (NGAL), marking the beginning of commercial rollout in the U.S. pediatric market. Total NGAL sales rose 5% (10% at constant exchange rates), while rest-of-world NGAL sales declined due to a non-recurring large bulk order in Q3 2024. Adjusted EBITDA improved slightly to –DKK 16.8m from –DKK 19.6m last year.

Operationally, BioPorto completed patient enrollment for its U.S. adult NGAL cut-off study at the end of October, though data analysis is taking longer than planned. As a result, the company now expects to submit its FDA pre-submission in Q1 2026, with the validation study to begin thereafter. The full adult FDA submission timeline has shifted from end-2026 into H1 2027, with clearance still targeted during 2027, as recently announced in the “Forward” strategy update, which focuses on building U.S. hospital adoption, progressing toward EU IVDR certification, and expanding the addressable market through 2028.

BioPorto also strengthened its balance sheet with a fully subscribed private placement of 40.4m shares, raising DKK 43m on 13 November 2025. Funding is now expected to cover operations throughout 2026, supporting the completion of adult clinical milestones and commercial expansion. Management reiterates targets of reaching positive cash flow in H2 2027, 60+ active U.S. hospitals in 2026, and 100+ globally in 2027. The capital raise significantly de-risks the roadmap while leaving a smaller remaining funding gap.

Guidance for 2025 was maintained following the early November revision: revenue DKK 40-45m and adjusted EBITDA DKK 75–80m, with sales expected to remain back-end loaded. Overall, Q3 shows steady commercial progress in the U.S., but the updated clinical timeline and higher investment needs underscore the importance of execution under the new strategy. 

To learn more, join the presentation of the Q3 2025 results with BioPorto CFO Niels Høy Nielsen at 11:00 CET today. Link: https://www.inderes.dk/videos/bioporto-praesentation-af-q3-2025-resultater

Disclaimer: HC Andersen Capital receives payment from BioPorto for a DigitalIR/Corporate visibility agreement / Philip Coombes 07:37 19/11/2025

BioPorto er et dansk In-vitro diagnostisk (IVD) selskab med hovedkontor i København, Danmark. Selskabet blev grundlagt i 2000. BioPorto har allerede ét produkt på markedet, NGAL-testen, som er til tidlig diagnosticering af akutte nyreskade (AKI). Den er kommercielt tilgængelig i Europa, Canada, Asien og Israel. NGAL-testen har modtaget banebrydende betegnelser fra FDA for akutte nyreskader til babyer, børn og unge under 18 år for hvilken den i øjeblikket udfører dataanalyser efter afslutningen af indrulning af patienter til dets fase 3-studie, som vil føre til en ansøgning til FDA. Fremtidige planer inkluderer yderligere FDA-indsendelse til voksenindikation såvel som andre markeder.

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