March 17, 2021
Announcement no. 4
Emerging strong from a year challenged by COVID-19
Highlights from the 2020 Annual Report
Patient enrollment for The NGAL Test clinical trial for pediatrics initiated in June 2020
Initiation of development in April 2020 and advancement to clinical testing of near-patient COVID-19 test based on gRAD in December 2020
CE-mark obtained of NGALds, the first test based on the gRAD platform, in late-2020
Two rights issues completed yielding proceeds of more than DKK 130 million
BioPorto’s activities in 2020 were shaped by an urgent need to respond to the COVID-19 pandemic and the ways it redefined the premise of our daily lives. While the pandemic immediately created volatility and difficulty in near term planning and execution, it also reinforced our efforts on maximizing our focus, diligence, and agility.
“Given the difficult circumstances in 2020, BioPorto undertook and advanced our most critical tasks. We initiated enrollment of patients in the US clinical trial for pediatric use of The NGAL Test for Acute Kidney Injury (AKI), our lead product. Furthermore, we obtained CE mark for our first product on the proprietary gRAD platform with the NGALds. And in parallel we responded to the diagnostic crisis presented by the pandemic by initiating a partnered development process for a COVID-19 rapid test based on gRAD. Finally, we secured a strong financial foundation to support our ongoing development, by executing an ambitious financing plan comprising two rights issues with proceeds of more than DKK 130 million,” said Peter Mørch Eriksen, CEO of BioPorto.
2021 will be a pivotal year
In 2020, COVID-19 brought significant challenges in patient enrollment, as hospitals were forced to prioritize patient care over clinical research. Subject to the developments of the pandemic during 2021, BioPorto therefore expects to conclude its study in the summer of 2021 and thereafter submit its application on pediatric use of The NGAL Test to the FDA.
The COVID-19 test based on gRAD is also currenting being tested with patient samples in the US. If successful, BioPorto plans to request an emergency use authorization in the US and a CE mark in Europe in second quarter 2021.
“While 2020 on all accounts was a difficult year, I believe BioPorto has faced the challenges head-on and emerged as a company at its strongest. On that basis, I expect 2021 will be a pivotal year,
where we will submit several applications to FDA and European health care authorities. If these are successful they will lay a very strong foundation for commercialization and the next phase in the development of the company,” Mr Eriksen commented.
2021 financial guidance
For 2021, BioPorto expects revenue of approximately DKK 30 million and an EBIT loss of approximately DKK 73 million. This excludes revenues from potential sales of a COVID-19 lateral flow test, and with only early sales from a FDA cleared NGAL product for pediatrics.
The main growth driver in 2021 will be product sales of The NGAL Test in EU and ROW, while sales of antibodies and ELISA kits are expected to continue to decline due to BioPorto’s strategic refocus on products generated from its own antibody library. As has been the recent pattern, 2021 revenues will be back-end loaded.
Selected Financial Highlights 2016-2020
Operating profit/loss (EBIT)
Profit/loss for the year
For further information, please contact:
Peter Mørch Eriksen, CEO
Telephone + 45 4529 0000, email firstname.lastname@example.org
BioPorto is an in vitro diagnostics company that provides tests and antibodies to clinicians and researchers around the world. We use our antibody and assay expertise to transform novel research tools into clinically actionable biomarkers that can make a difference in patients’ lives. BioPorto is headquartered in Hellerup, Denmark and is listed on the NASDAQ Copenhagen stock exchange [CPH:BIOPOR].