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Market Cap £111.1m
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BioPorto Announces Q1 2021 Report

Wed 12th May, 2021 7:42am
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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.”

Investor Meeting

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

For further information, please contact:

Peter Mørch Eriksen, CEO

Telephone +45 4529 0000, e-mail:

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 .

*     2021 05 12 - Announcement no. 11
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