May 12, 2021
Announcement no. 11
Q1 2021 Report
Revenue growth of 33% in Q1 2021
In the first quarter of 2021, BioPorto grew revenue by 33% driven by strong sales of antibodies. Revenue from product sales of The NGAL Test™ was maintained at last year’s high level with solid performance in both the US and Rest of the World (ROW).
Enrollment of patients in The NGAL Test US pivotal trial continues, summer completion anticipated
All internal studies to support BioPorto’s US application for The NGAL Test for pediatric acute kidney injury (AKI) are being finalized according to schedule, and enrollment continues in the pivotal study of critically ill pediatric patients. Based on the current status of the COVID-19 pandemic, the company continues to expect to complete its pivotal study this summer, after which it will submit a De Novo 510(k) application to the US Food and Drug Administration (FDA).
Results from testing of the gRAD-based COVID-19 test expected in Q2 2021
BioPorto and the University of California, Davis (US) are working diligently to obtain test results on the company’s gRAD-based point-of-care test for SARS-CoV-2. Having experienced initial challenges early in 2021, the testing is progressing and will be finalized in the second quarter of 2021. If the results support BioPorto’s initial laboratory findings, the company intends to submit an Emergency Use Authorization (EUA) request to the FDA and a CE mark filing in Europe.
Guidance for 2021 maintained
Based on the progress and results obtained in the first quarter of 2021, BioPorto maintains its financial guidance for 2021, as most recently described in its Annual Report for 2020. Revenue of approximately DKK 30 million is expected in 2021. An operating loss (EBIT) of approximately DKK 73 million is forecast for the year.
Peter M. Eriksen, CEO, commented:
“Viewed in the light of a quarter still heavily influenced by the severity of the global third wave of COVID-19, I am satisfied with BioPorto’s performance. We drove revenue up by more than 30% by utilizing all of our assets, despite limited access to key markets for key products. In this context, I believe maintaining revenue from product sales of The NGAL Test at last year’s high level is a solid achievement and I am glad to see our own library of antibodies performing very well.
Our clinical efforts and regulatory processes have been difficult to advance in the continued COVID-19 climate. In the first quarter of 2021, we have pushed hard on both clinical programs for The NGAL Test and the COVID-19 gRAD-based test to ensure we meet our timelines ahead. We will continue to do this, for example by bringing new hospital sites into our pivotal study to boost enrollment in the coming months.”
In connection with the release of the Interim Report for the first quarter of 2021, BioPorto will host an online investor presentation on May 12, 2021 at 12:00 CET in Danish and at 16:00 CET in English. For further information regarding the online investor meeting, please visit www.bioporto.com/investor-relations.
For further information, please contact:
Peter Mørch Eriksen, CEO
Telephone +45 4529 0000, e-mail: email@example.com
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].