BioPorto A/S (CPH:BIOPOR) has published its 2020 Annual Report in which it said 2021 "will be a pivotal year".
The Danish in-vitro diagnostics company's CEO Peter Mørch Eriksen said in the report: “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.”
READ: BioPorto expects to complete its clinical study and submit a De Novo application to the US FDA for pediatric use of its NGAL kidney test this summer
Eriksen added: "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.”
BioPorto also provided financial guidance for 2021. The company said it expects revenue of approximately DKK 30 million (around US$4.8 million) and an EBIT loss of approximately DKK 73 million (around US$11.7 million). That excludes revenues from potential sales of a COVID-19 lateral flow test, and with only early sales from a US Food & Driug Administration (FDA) cleared NGAL kidney test product for pediatrics.
The company said the main growth driver in 2021 will be product sales of The NGAL Test in the European Union and the Rest of the World, 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, it added.
In 2020, the coronavirus (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 company's COVID-19 test based on gRAD is also currently 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 the second quarter of 2021, Eriksen said.
Highlights from the 2020 Annual Report included:
- 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 provides tests and antibodies to clinicians and researchers around the world. The company uses its 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.
Contact the author at jon.hopkins@proactiveinvestors.com