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.
CEO Peter M. Eriksen confirmed the solid underlying growth in The NGAL-test in CE marked areas of 25%YoY, further the company keeps a tight cost control and holds DKK 66 mio. in cash end 2023.
After a slow start to 2024, February and the beginning of March turned out to be a very strong period for Biotech and Life Science stocks as illustrated above. Even more so, if measured since late October 2023. Looking at 2024, the general S&P Biotech index is now up 7.7 percent year-to-date, outperforming MSCI World All Countries which is up 7.0 percent. Nordic focused HCA Little Mermaid index is up 6.0 percent.
BioPorto announces ambitious strategy-plan, but investor concern regarding an upcoming rights issue has put pressure on the stock
BioPorto pre-announced part of their 2023 report last week, which is scheduled to be published in full on April 4th. BioPortro expects revenue of DKK 40 mill. and an EBITDA of -80 mill. in 2024. More importantly, BioPorto also announced its new strategy which is expected to bring BioPorto to plus USD 100 mill. in annual revenue over the next 5 years.
The investment case is driven by the potential for BioPorto to successfully leverage the marketing authorization (FDA approval) for ProNephro AKI for pediatrics, to also be approved for adult use, as well as, for use in other settings and in other geographical areas (Rest of World).
The strong finish to 2023 didn’t last into 2024 as Biotech and Life Science stocks moved sideways the last month and were unable to keep pace with the general stock market, which managed to climb to new record highs.
BioPorto announced yesterday after the market close that the company has received the long-awaited FDA approval to market and sell its NGAL test, which will be marketed under the name ProNephro AKI (NGAL) for(Acute Kidney Injury).