Bioporto (One-pager): Emerging as a Diagnostic growth company

The investment case is driven by BioPorto's ability to leverage the FDA marketing authorization of ProNephro AKI (NGAL) for pediatric use as a stepping stone for future approvals for adult use and other applications.

In February 2024, BioPorto announced a five-year strategy (2024–2029) targeting USD 100 million in annual revenue and profitability by 2029 (see Appendix, page 4).

The initial phase of this strategy (Phase 1) spans from 2024 to mid-2025, with six key objectives. In the latest Q3 report, the company reaffirmed its guidance of USD 6 million in revenue and a negative cash flow for 2024. While no revenue from the Roche partnership on ProNephro AKI (NGAL) in the US has yet materialized, strong sales of NGAL RUO in the US, Canada and RoW are expected to support the company’s 2024 revenue guidance. Sales from the Roche partnership are now projected to begin in early 2025.

In 2024, BioPorto expanded the number of instruments testing ProNephro AKI (NGAL) in collaboration with Roche and established a global partnership with Beckman Coulter, focusing primarily on the European market. The company also holds CE approval for both pediatric and adult use of  NGAL in Europe.

In addition to these efforts, BioPorto successfully raised approximately USD 12 million of the USD 20 million planned for Phase 1, with support from both existing and new investors. The funds are allocated to finance new clinical trials for FDA clearance of ProNephro AKI (NGAL) for adult use in the US, expand sales and marketing for the current product line, including the NGAL Test, and support general corporate activities.

Furthermore, BioPorto has swiftly drafted the study protocol and enrolled the first patients in the adult ProNephro AKI (NGAL) trial at Massachusetts General Hospital, MA (US), ahead of its original schedule.

To summarize Phase 1, meaningful revenue from partnerships is anticipated in the first half of 2025. Progress in patient enrollment for the adult ProNephro AKI (NGAL) study in the US is on track. The ongoing study is the first of two pivotal trials forming the basis for FDA submission for adult use approval.

The total addressable market (TAM) for the AKI diagnostic market is estimated at approximately USD 3 billion, with a projected annual growth rate of 5%, driven by a shift in diagnostic paradigms.

Using a DCF modeling approach with a defined set of assumptions, the probability of success (PoS) for the pediatric ProNephro AKI (NGAL) launch is currently assessed at over 100% by the market. This indicates that the market has fully priced in the successful commercialization of the product for pediatric use in the US.

However, for the more important indication for adult use, applications in other settings, and broader geographical markets, which together represent a TAM of approximately USD 3 billion annually, the model suggests the market assigns a PoS of just 54% in the base case scenario.

Disclaimer: HC Andersen Capital receives payment from Bioporto for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 11:45 AM 10-12-2024