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Analyst Comment

Interview with management - highlights from Q2

By Claus ThestrupCEO, Sweden
BioPorto

Interview with CEO Tony Paré and CFO Niel Goldman about events during Q2.

Overall management seems confident about the pipeline and current sales of NGAL in Europe and Korea. Earlier this year Bioporto re-started sales of NGAL in Europe, where it already hold a CE mark for the product. They don't need any additional approval for pediatric or adult use. Sales is up on both QoQ and YoY in Q2. they use a multi channel approach for selected markets. There is an untapped market of around USD 1bn.

Bioporto submitted comprehensive response to US FDA Additional Information Letter for De Novo application of NGAL tests for pediatric patients (aged 3 months – 22 years) earlier this summer. NGAL if approved will improve the standard of care compare with today's treatment. The rescue window is from 2-48 hours. NGLA shows results after 2 hours and today's therapy shows results after 48-72 hours. If/When Bioporto get FDA clearance - They will establish a beachhead in the US market focused on testing pediatric patients. 

Bioporto is well finance after the latest rights issue. They have DKK 85,4 in total cash as of June 2023. No changes to financial guidance for 2023.

Listen to the interview here: https://www.youtube.com/watch?v=QGKMr9fDm9I

Due to some technical issues, there is no introduction and one slide misses, we are sorry about that!

Bioporto will participate in our Life Science seminar the 31.st of August 2023.

Disclaimer:

HC Andersen Capital receives payment from Bioport for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 7:40 AM 02-08-2023.

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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.

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