BioPorto (One-pager): Q4 and new 2026 guidance reinforce "Forward" strategy momentum
Oversigt
- BioPorto rapporterede en stærk Q4 2025 med en omsætning på DKK 11,6 mio., en stigning på 47% YoY, drevet af amerikanske NGAL RUO-salg og strategiske distributørordrer.
- For 2026 sigter BioPorto mod en omsætning på DKK 48–58 mio. og en justeret EBITDA-tab på DKK 50–60 mio., hvilket bekræfter fremdriften i "Forward"-strategien.
- Regulatorisk tidslinje er bekræftet med forventet FDA pre-submission ved udgangen af Q1 2026 og endelig indsendelse i H1 2027.
- Væsentlige risici inkluderer langsommere hospitalsadoption, usikkerhed omkring KDIGO-retningslinjer og potentielle yderligere aktieudvanding, selvom nuværende likviditet dækker aktiviteter indtil 2026.
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We have made minor adjustments to our BioPorto one-pager following the release of preliminary 2025 figures, 2026 financial guidance, and a business update.
Q4 2025 was the strongest quarter of the year, with revenue of DKK 11.6m, up 47% YoY (52% at constant exchange rates), driven by continued momentum in U.S. NGAL RUO sales and a larger bulk order from strategic distributors. Full-year revenue and adjusted EBITDA both landed within the latest disclosed guidance.
Although early in the journey, the results and new 2026 guidance confirm continued execution on the "Forward" strategy. BioPorto is targeting DKK 48–58m in total revenue for 2026 (20–45% growth) and an adjusted EBITDA loss of DKK 50–60m (22–35% improvement).
Management reiterated the 2028 aspirations of DKK 150–200m in revenue, at least 15% adjusted EBITDA margin, and achieving positive cash flow in H2 2027.
On the regulatory side, the timeline was confirmed. The adult cut-off study database lock and an FDA pre-submission are both expected by the end of Q1 2026, with the validation study running through 2026 into H1 2027 and final FDA submission still targeted by the end of H1 2027.
The core investment case remains the same. BioPorto is commercializing the first and only FDA-cleared NGAL test for pediatric AKI in the U.S., targeting a directly addressable market of approximately USD 700m annually. Partnerships with Roche and Beckman Coulter validate the product and enable scalable distribution, with potential to secure agreements with the three remaining Big Five instrument providers. The quarterly progression in hospital adoption, the introduction of 2026 guidance, and the narrowing EBITDA loss add visibility to the near-term trajectory, while FDA clearance for the adult NGAL test and potential KDIGO guideline inclusion remain key catalysts for accelerated growth.
From a valuation perspective, the market-implied probability of success (PoS) in our base case remains around xx%, which should be seen in the context of a diagnostics company with a product already on the market, FDA clearance for pediatrics, and validated partnerships with two of the Big Five instrument providers—but also a company still in the early innings of delivering on the mid-term targets set out in the new strategy. Key catalysts to narrow this discount in 2026 include continued hospital adoption progress, the FDA pre-submission milestone, and potential KDIGO guideline inclusion.
Key risks include slower-than-expected hospital adoption and partner-driven growth, uncertainty around KDIGO guideline inclusion, the inherent risk around FDA clearance for the adult NGAL test, and potential further shareholder dilution to fund activities into 2027—although the current cash position covers operations through 2026 and management is pursuing non-dilutive financing options.
Disclaimer: HC Andersen Capital receives payment from BioPorto for a Digital IR/Corporate Visibility subscription agreement. / Philip Coombes 14:15 11/02/2026