Interview with management - highlights from Q2
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.
BioPorto er et dansk In-vitro diagnostisk (IVD) selskab med hovedkontor i København, Danmark. Selskabet blev grundlagt i 2000. BioPorto har allerede ét produkt på markedet, NGAL-testen, som er til tidlig diagnosticering af akutte nyreskade (AKI). Den er kommercielt tilgængelig i Europa, Canada, Asien og Israel. NGAL-testen har modtaget banebrydende betegnelser fra FDA for akutte nyreskader til babyer, børn og unge under 18 år for hvilken den i øjeblikket udfører dataanalyser efter afslutningen af indrulning af patienter til dets fase 3-studie, som vil føre til en ansøgning til FDA. Fremtidige planer inkluderer yderligere FDA-indsendelse til voksenindikation såvel som andre markeder.
Read more on company pageForum opdateringer
