BioPorto Announces Q2 2021 Report

August 18, 2021
Announcement no. 14
Q2 2021 Report

Highlights

Solid revenue growth in the first half of 2021

In the first half of 2021, BioPorto’s revenue grew by 20% measured in USD and 11% when measured in DKK, driven by strong sales of antibodies and higher research use only (RUO) sales of The NGAL Test™ in the US. In the second quarter of 2021, revenue from antibodies was up 118% and RUO sales of The NGAL Test in the US increased 84% in USD and 68% in DKK.

Enrollment in the US clinical trial of The NGAL Test continues; interim re sults expected end‐August 2021

Enrollment of patients in the study to support a De Novo 510(k) application for The NGAL Test for use in pediatrics has progressed well in the second quarter of 2021. During this period BioPorto also brought on board several new trial sites, contributing to further progress in patient enrollment.

To obtain an indication of likely study outcomes and to optimize the statistical data, BioPorto will conduct an interim analysis of results from the current enrollment at the end of August 2021. Based on expected positive findings, the results of the analysis are expected to guide finalization of the study to strengthen the submission to FDA.

Dialogue on Emergency Use Authorization of The NGAL Test in the US for COVID‐19 patients

Based on results from an ELISA and dipstick study of NGAL to screen for renal failure in COVID‐19 patients conducted by clinical researchers at Columbia University’s Irving Medical Center (US) (Source: Xu, Shang et al, “Urine Test Predicts Kidney Injury and Death in COVID-19”, medRxiv), BioPorto initiated a dialogue with the FDA in July on a potential Emergency Use Authorization (EUA) of The NGAL Test for use in the assessment of kidney injury and the prediction for renal replacement therapy in COVID‐19 patients.

Data collection for gRAD COVID‐19 test to continue in Q3 2021

In the second quarter of 2021, BioPorto has continued testing of its point‐ of‐care assay for SARS‐CoV‐2 in Denmark. Prioritization has been given to achieving a sensitivity of more than 80% to realize the clinical and commercial potential of the gRAD‐based test, compared to other rapid test formats. Consequently, in June BioPorto decided to continue the data collection period into the third quarter of 2021.

Guidance for 2021 maintained

Based on the progress and results obtained in first half of 2021, BioPorto maintains its financial guidance for 2021, as most recently described in its interim report for the first quarter of 2021. 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:
“We have seen strong and satisfying growth in the second quarter and in‐ deed in the first half of 2021 for antibodies and within US research use only sales of The NGAL Test. The momentum is encouraging although dark clouds are still on the horizon in the form of new mutations of the COVID‐19 virus, causing short term uncertainty and lack of visibility.

On the development side, BioPorto has had a busy schedule and good performance in the second quarter of 2021, considering the obstacles presented by COVID‐19. I expect our clinical and regulatory progress will be converted into an exciting news flow this fall. First, at the end of August we will analyze interim data from the US clinical study for The NGAL Test in pediatrics. The interim results will provide a strong indication of the test’s performance on key clinical variables and on the statistical power of the study. Second, we expect to have progressed both the FDA discussion on an EUA for use of The NGAL Test in COVID‐19 patients at risk of renal failure, and third, we will conclude the COVID‐19 gRAD studies that are currently being undertaken in Denmark. In addition, we expect to publish news on the gRAD sepsis study that we have undertaken with Righospitalet in Denmark. With these prospects in the pipeline and the anticipation of a new organizational structure in place in the next few months, we are looking at an eventful and important second half of 2021.”

Investor Meeting

In connection with the release of the Interim Report for the second quarter of 2021, BioPorto will host an online investor presentation on August 18, 2021, at 15:00 CET in Danish and at 16:00 CET in English. For further information regarding the online investor meeting, please visit www.bi‐ oporto.com/investor‐relations.

For further information, please contact:

Peter Mørch Eriksen, CEO

Tim Eriksen, Investor Relations

Telephone +45 4529 0000, e-mail: investor@bioporto.com

About BioPorto

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].

Attachment

• 2021 08 18 – Announcement no. 14