In connection with the publication of BioPorto's H1 2026 interim results, we have updated our investment case, covering the key investment reasons, risks, and valuation perspectives. 

The quarter delivered progress on the three pillars that the investment case and delivery on the long-term sales targets hinge on. These are FDA clearance and US market entry for adults, strong inclusion in the KDIGO guidelines, and creating access through an increased number of hospitals while establishing health economics for early AKI detection using NGAL.

On the regulatory pillar, FDA pre-submission feedback arrived in June and the adult validation study was initiated in August, with the first US site activated on 18 August. The study was enlarged to some 900 patients, which pushed submission to H1 2028 and clearance to mid-2028, but it also puts the final regulatory step in motion.

On guidelines, the draft KDIGO update from end-March recommends biomarker use in AKI and moved into finalisation after the comment period closed in April. The final guideline is expected late 2026 and remains the nearest hard catalyst, as inclusion would shift NGAL from a discretionary add-on to a compliance tool.

On access, ten new US hospitals were on-boarded in the half, taking the active base to 54 against a target of 60+ by year-end. A site counts only once it has placed an order, so these are paying customers rather than pilots, and the near-term test is whether the Roche and Beckman Coulter partnerships convert them into recurring revenue. 

That access is turning into sales was supported by the results, which were stronger than the headline figures suggest. Operative revenue for the half-year grew 22% to DKK 19.1m (31% at constant exchange rates), with NGAL revenue up 25% to DKK 15.2m. Q2 NGAL revenue of around DKK 9.2m grew some 20% while absorbing the full DKK 2.8m reversal from the voluntary recall announced on 21 May, so underlying growth was materially higher. Management confirmed the matter is closed in the accounts, and full-year guidance was maintained at DKK 38-48m in revenue and an adj. EBITDA loss of DKK 58-68m rather than reset. The operative adj. EBITDA loss narrowed 33% to DKK 31.4m and cash stood at DKK 75.6m.

Set against this, the enlarged study added some DKK 20m of costs and moved cash flow positive from H1 to H2 2028, leaving little buffer against a runway reaching mid-2028. Management has no plans for an equity raise and intends to bridge this through operational efficiencies and, if needed, credit facilities. 

We have made only limited changes to our PoS model and the key investment and reasons and risks. The adult ramp-up is now modelled from clearance in mid-2028 rather than the previous timeline, and non-NGAL revenue carries only a small value following the antibody divestment. Market size, growth, peak market shares, royalty rate, EBIT margin and the 15% discount rate are unchanged.

From a valuation perspective, our model-implied PoS has been updated for the H1 results and the revised regulatory timeline. The market currently implies a base-case probability of success of around 62%, with the bear case at 81% and the bull case at 46%. The base case is now broadly in line with typical Phase 3 approval probabilities in adults, so the bull case marks where upside would have to come from, and delivery on the three pillars is what closes that gap.

For more insights into the results and the outlook, you can watch the management presentation of the H1 2026 results here: https://www.inderes.dk/videos/bioporto-praesentation-af-h1-2026-resultater 

Disclaimer: HC Andersen Capital receives payment from BioPorto for a Digital IR/Corporate Visibility subscription agreement /Michael Friis and Victor Skriver 15:45 03.09.2026.