Research

BioPorto (Investment Case): Executing on the Forward strategy with adult pre-submission filed in Q1 2026

Summary

BioPorto's 2025 revenue grew by 11% to DKK 40.3m, with significant contributions from US NGAL RUO sales and ProNephro AKI distributor revenues, while the gross margin improved to 75%.
For 2026, BioPorto projects total revenue growth of 20-45% and aims to expand hospital adoption to over 60 active US sites by year-end, despite an expected adj. EBITDA loss of DKK 50-60m.
Key developments include positive preliminary results from the adult cut-off study and the filing of the FDA pre-submission package, alongside KDIGO's draft 2026 AKI guidelines recommending biomarker use.
Risks involve FDA clearance uncertainty, partner-dependent growth, and funding needs, while valuation perspectives indicate a low market-implied probability of success at 46% for a diagnostics company with existing market presence.

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In connection with the publication of BioPorto's annual report for 2025 and recent announcements, we have updated our investment case.

2025 was a year of strategic repositioning for BioPorto. Revenue grew 11% to DKK 40.3m, driven by 25% growth in US NGAL RUO sales to DKK 18.4m and the first ProNephro AKI distributor revenues of DKK 4.3m via Roche. The gross margin improved to 75% from 68%, while adj. EBITDA loss widened to DKK -76.5m (from -70.6m) as R&D costs increased to DKK 50.5m, driven by the adult clinical study. BioPorto ended 2025 with 44 active US hospitals and DKK 54.9m in cash following two private placements totalling approximately DKK 77m.

For 2026, BioPorto guides total revenue of DKK 48-58m (20-45% growth), NGAL revenue of DKK 33-42m, and an adj. EBITDA loss of DKK 50-60m. Growth is expected to be back-end loaded as hospital adoption scales towards the target of 60+ active US sites by year-end.

Two significant catalysts arrived in late March 2026. On 18 March, BioPorto reported positive preliminary results from the adult cut-off study, supporting the primary endpoint and consistent with the pediatric data that led to FDA clearance. The FDA pre-submission package was formally filed on 31 March. Separately, on 31 March, KDIGO published its draft 2026 AKI guidelines (the first update since 2012) which recommend biomarker use for early AKI identification. The draft is open for public comment until 27 April 2026. If finalised, KDIGO inclusion can drive pull-through demand and support reimbursement eligibility.

Our investment case covers the key investment reasons, risks, and valuation perspectives.

The key investment reasons centre on continued commercialisation of BioPorto’s NGAL test in partnership with leading ICU hospitals, and with via partnerships with Roche and Beckman Coulter. Following the revised “Forward” Strategy executing on the new targets will be key to building investor confidence in the mid-term targets and delivering on the adult test pre-submission in Q1 2026, as it has is the first step along that track.

The key risks include the inherent uncertainty of FDA adult clearance (targeted end-2027), third-party risk from partner-dependent growth, which has been slower than expected, and funding risk as management expects approximately DKK 20-30m in additional capital is needed to bridge to cash flow positive in H2 2027, which will result in further dilution.

From a valuation perspective, our model-implied POS across three scenarios, the market currently implies a base case probability of success of approximately 46%, which remains low for a diagnostics company with a product already on the market and two significant catalysts now delivered. Near-term catalysts include validation study initiation following FDA feedback, continued hospital adoption towards the 60+ target, and finalisation of the KDIGO guidelines.

For more insights into the results and the outlook, you can watch the management presentation of the FY 2025 results and 2026 outlook here: https://www.inderes.dk/videos/bioporto-praesentation-af-fy-2025-resultater

Disclaimer: HC Andersen Capital receives payment from BioPorto for a Digital IR/Corporate Visibility subscription agreement. The authors do not own shares in BioPorto. This is not a piece of advice to buy, not to buy, sell, or not to sell shares. HC Andersen Capital assumes no responsibility for the correctness of the contents of the material. / Philip Coombes 16:37 01/04/2026

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.