BioPorto Announces Q3 2020 Report

November 18, 2020
Announcement no. 21
Q3 2020 Report


Highlights

BioPorto will this week initiate patient enrollment for trial of its COVID-19 rapid test

In April 2020, BioPorto deployed an accelerated process to develop an accurate, rapid, point-of-care test for SARS-CoV-2, the virus that causes COVID-19.

The development process has progressed well in the past several months, and in an important advancement, BioPorto will begin collection of patient samples at the University of California, Davis this week. These samples are expected to be collected and analyzed by the end of December. The data from this analysis will form an essential part of the Company's application for Emergency Use Authorization (EUA), which BioPorto is planning to submit to the US Food and Drug administration (FDA).

Provided the clinical study is completed according to plan and the EUA is granted, BioPorto expects to be able to initiate commercialization in the beginning of 2021.

Analytical studies for The NGAL Test™ application on track, but COVID-19 slows clinical enrollment

BioPorto announced the first patient enrollment for its US pediatric clinical trial of The NGAL Test™ in June 2020. Since then, leading US children's hospitals have continued enrolling patients in the study, and BioPorto has conducted analytical studies according to the Company's plan. However, the global second wave of SARS-CoV-2 infections has restricted BioPorto's access to hospitals and limited the health care system's ability to process and conduct studies according to the originally anticipated schedule. As a result, BioPorto expects to finalize patient enrollment, complete the data analysis and submit a De Novo application to the FDA in Q1 2021, based on the current outlook for the COVID-19 pandemic.

Product sales of The NGAL Test grew by 58% year-to-date

In Q3 2020, revenue generated by sales of The NGAL Test was up 17% compared to Q3 2019. After very strong performance of Research Use Only (RUO) sales in the US in the first half of 2020, US sales in Q3 2020 grew by 2% versus the prior year's Q3, and were up 28% over Q2 2020. In Q3 sales in the Rest of the World (ROW) increased by 80%.

In total, product sales of The NGAL Test in the first nine months of 2020 increased by 58% YoY to DKK 9.8 million, demonstrating that interest in NGAL continues to expand worldwide.

CE Mark of NGALds for near-patient testing expected at the end of 2020

BioPorto expects to self-declare in the EU (CE Mark) its novel gRAD-based test for near-patient measurement of NGAL by late-2020. BioPorto will immediately thereafter initiate commercialization of the test in select countries through established distribution channels.

BioPorto completes fully guaranteed Rights Issue with net proceeds of DKK 93.6 Million

In September 2020, BioPorto initiated a fully guaranteed Rights Issue of 66,645,467 new shares with pre-emptive subscription rights for existing shareholders. The fully guaranteed and highly oversubscribed Rights Issue was successfully completed in October 2020 and yielded net proceeds of DKK 93.6 million. The cash will be allocated to finance the company's operations until October 2021 and to the further development of both NGAL products and the gRAD platform, including the development of tests for new indications.

Guidance for 2020 maintained

BioPorto maintains its financial guidance for 2020, as most recently described in the Interim Report for the second quarter of 2020. Revenue of approximately DKK 30 million is expected in 2020. An operating loss (EBIT) of approximately DKK 73 million is forecast for the year.

Peter M. Eriksen, CEO, Commented:

"I am happy with the operational execution of the organization in Q3 2020. We maintained a solid momentum on sales of The NGAL Test - even compared to a very strong Q3 last year - and saw growth in product driven sales of the test of 58% year to date over the same period last year. This clearly shows that revenue from the test has not been affected by COVID-19. In Q3 2020, we also showed strong progress in the development of new rapid tests on the gRAD platform. We are pushing hard to take the COVID-19 test to trials in Q4 2020 and anticipate generating revenue from this promising viral antigen test early in 2021.

During the quarter, we started enrolling patients in a pediatric clinical trial in the US for the De Novo application to the FDA for The NGAL Test. As we are facing restricted access to hospitals due to the global second wave of COVID-19, we have seen the pace of enrollment slow. This will delay the enrollment completion to Q1 2021.

Finally, we initiated the largest fundraising campaign in BioPorto's history in Q3 2020 through a fully guaranteed Rights Issue. I am very satisfied with the significant interest and support received from investors which resulted in an oversubscribed issue that was completed in October 2020 with net proceeds of DKK 93.6 million. This means we have capitalized BioPorto to enable us to execute on an ambitious strategic trajectory with several critical milestones ahead of us the next 12 months."

Investor meeting

In connection with the release of the Interim Report for the nine months of 2020, BioPorto will host an online investor presentation on November 18, 2020 at 15:00 CET in Danish and at 16:00 CET in English. For further information regarding the online investor meeting, please visit
https://bioporto.com/investor-relations.

For further information, please contact:

Peter Mørch Eriksen, CEO

Ole Larsen, CFO

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].

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