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BioPorto has announced the appointment of Anthony Pare and Neil Goldman as its new CEO and CFO, respectively, with effect from mid-November 2021. In addition, Thomas Magnussen, chairman of the Board of Directors, has decided to step down from his position, with vice chairman Christopher Lindop taking over. We note that both the CEO and CFO are US-domiciled and view these appointments as strategic given the company’s increasing focus on the US market as it inches closer to the completion of clini
Companies: BioPorto A/S (0JJM:LON)BioPorto A/S (BIOPOR:CSE)
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BioPorto has reported its results for Q121, which included DKK5.6m in sales from all its research use only products. This is up from Q120 (DKK4.2m) but comparable to Q119 (DKK5.5m). The biggest near-term driver for the company’s revenue will be the pending results of its pivotal paediatric acute kidney injury (AKI) clinical study, which is slated to complete in summer 2021, and the subsequent regulatory submission to the FDA for De Novo 510(k) clearance.
BioPorto managed to continue sales growth for its NGAL research-use only (RUO) product in 2020 despite the headwinds of COVID-19. Sales of the product increased 28% over the prior year (DKK13.4m from DKK10.5m) despite the disruption. We are encouraged to see this growth as we expect physicians with exposure to the test to become the first customers after the launch of the approved NGAL Test for clinical use.
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BioPorto has started 2021 firing on all cylinders as it prepares to resubmit its application to the FDA for the paediatric NGAL Test for detecting acute kidney injury (AKI) in summer 2021. This should set it up for a clearance decision in H221, after which it plans to submit the application for the adult NGAL Test. Concurrent with this, the company is initiating clinical testing of its COVID-19 dipstick. It expects this testing to be complete in early 2021 and emergency use authorisation (EUA) t
With its Q320 earnings, BioPorto announced that its COVID-19 antigen test it has under development would be entering the clinic. The gathering of samples is expected to start imminently and to be complete by the end of December 2020. The company believes that this timeline supports the potential commercialisation of the product in early 2021, if the results of the study are compelling.
Companies: BioPorto A/S
BioPorto reported a major increase in Q220 sales for the NGAL research use only (RUO) test, to DKK5.0m, up from DKK3.8m in Q219. This is the single highest quarter for NGAL RUO sales, and uptake in the US has been especially strong, up 95% y-o-y. Sales for the company’s other products were down (DKK1.7m, from DKK4.0m in Q219) reflecting the company’s shift in focus to NGAL. Although RUO NGAL sales remain relatively small, they represent the beachhead for the eventual launch of the FDA-cleared NG
BioPorto announced in its Q120 earnings update that the timeline for submission of its paediatric NGAL Test would be delayed to H220 (from previous guidance of Q220) on account of COVID-19. The planned clinical study to investigate the test for risk assessment of acute kidney injury (AKI) has been put on hold due to the ongoing pandemic. This will also delay the submission of the adult NGAL Test as it was planned to occur after the paediatric submission.
BioPorto has announced a collaboration with the University of Southern Denmark (SDU) to develop a point-of-care (PoC) test for the detection of COVID-19. The test would employ the company's existing generic Rapid Assay Device (gRAD) platform for POC tests, but would require the development of anti-COVID-19 antibodies, which is being done at SDU.
BioPorto Diagnostics reported sales of DKK26.6m for 2019, driven in the largest part by sales of The NGAL test for research purposes (DKK11.6m). The company reported 9% growth in NGAL Test sales year-on-year for the US (DKK4.9m) and 9% growth as a whole, representing increasing interest in the technology. The company remains on track to submit a De Novo 510(k) application for the paediatric NGAL Test in mid-2020.
Following an interaction with the FDA, BioPorto announced on 18 November 2019 that it will need to gather more data to complete the 510(k) application for the paediatric NGAL Test. The company expects this process to take several months and to resubmit its application in Q220. The feedback from the FDA has implications relating to the ongoing adult NGAL study, which is now expected to be submitted after the paediatric application (pushed back from Q419).
BioPorto announced the decision to supplement its 510(k) paediatric application with additional data, rather than withdraw it. The FDA’s decision relating to The NGAL Test’s use in the risk assessment of acute kidney injury (AKI) in paediatric populations is expected by year end. In addition, the adult AKI programme is on track with expected FDA submission by year end. Our valuation is DKK993m (DKK5.67 per basic share).
In July 2019 BioPorto announced that the FDA had requested additional information for The NGAL Test’s 510(k) application for paediatric acute kidney injury (AKI), although few other details were disclosed. Unfortunately, the existing clinical data set does not include the requested information, so the company will need to withdraw its current application and collect additional samples, which carries additional risk (probability of success lowered to 50% from 60%). The company forecasts that it w
BioPorto announced that it had submitted an application to the FDA for the paediatric NGAL Test. The application was specifically for the risk assessment of acute kidney injury in children under the age of 21. The application was submitted with breakthrough designation, which we consider very encouraging. The designation shortens the statutory review time to 45 days (from 90) and provides that a portion of data needed be provided after marketing clearance.
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