BioPorto Announces Q3 2021 Report

November 17, 2021Announcement no. 21Q3 2021 Report

Highlights

Revenue growth driven by antibodies and RUO sales of The NGAL Test

In the first nine months of 2021, BioPorto’s revenue grew by 19% in USD (11% in DKK), driven by strong sales of antibodies and higher research use only (RUO) sales of The NGAL Test™ in the US. In third quarter 2021, ELISA kit sales also contributed to topline performance which grew 13% in USD (12% in DKK).

Appointment of new CEO and CFO and changes to the board of directors

Following the conclusion of successful search processes, BioPorto in October 2021 announced the appointments of Anthony (Tony) Pare as its new Chief Executive Officer (CEO) and Neil A. Goldman as its new Executive Vice President (EVP) and Chief Financial Officer (CFO). They will be joining Bio-Porto from global medtech companies by mid-November 2021 and both brings decades of executive experience in launching products, growing businesses and revenue and raising capital to BioPorto.

In November 2021, Thomas Magnussen resigned as member of the board of directors and Christopher Lindop succeeded him as chairman of the Board of Directors while John McDonough was elected as vice chairman. Furthermore, Peter Mørch Eriksen was on an extraordinary meeting elected as member of the board of directors.

Results from Interim Analysis of Data from The NGAL Test study are consistent with expectations, but enrollment delayed due to COVID-19

In August 2021, BioPorto concluded an interim analysis of data from the pediatric clinical trial to evaluate The NGAL Test as a tool for risk assessment of moderate to severe acute kidney injury (AKI). The interim analysis for the clinical performance of the assay provided results on sensitivity and specificity which were consistent with expectations.

While the number of participating study sites has increased in third quarter of 2021, enrollment of patients for the pediatric study has lately been impacted and delayed by the continuation of the COVID-19 pandemic which reduce access to patients. BioPorto therefore now expect to finalize data collection during the first half of 2022.

Testing of The NGAL Test for Emergency Use Authorization in relation to COVID-19 patients initiated

BioPorto has in third quarter 2021 progressed the dialogue with FDA on the potential Emergency Use Authorization (EUA) of The NGAL Test for use in the assessment of kidney injury and prediction of need for renal replacement therapy in COVID-19 patients. The dialogue with FDA has been promising and BioPorto has hence initiated testing of the original samples using The NGAL Test on a Roche analyzer.

Interim data for gRAD-based Sepsis test and results from COVID-19 test expected in fourth quarter 2021

The development of a gRAD-based test for the quantitative determination of thrombomodulin in human plasma or whole blood samples which BioPorto is undertaking with Rigshospitalet (DK) has further progressed in third quarter of 2021. Rigshospitalet, who is leading the study, is currently summarizing the results in an interim data report, which is expected to be finalized in fourth quarter 2021.

The data collection for a point-of-care assay for the COVID-19 continued in third quarter 2021. Initial testing results indicate a higher sensitivity compared to other rapid test formats. The results are currently being evaluated and BioPorto expects to conclude the analysis of the clinical potential before year-end 2021.

Guidance for 2021

Based on the development year-to-date, BioPorto expect to reduce the EBIT loss for 2021 from approximately DKK 73 million to now approximately DKK 63 million.

The revised EBIT guidance will have a positive effect on BioPorto’s cash position end-2021 compared to previous estimates. This implies that the Company based on the current outlook expects to have funding into third quarter 2022 whereas previously estimated to second quarter 2022.

For the financial year 2021, BioPorto adjust expectations for revenue to approximately DKK 24 million from previous guidance of DKK 30 million.

Peter M. Eriksen, CEO, commented: “As in previous quarters, we have seen a satisfying development in our activities in third quarter 2021. Antibody sales continue to be at a high level, and sales of The NGAL Test in the US for RUO is rising. More importantly, we also in third quarter 2021 received the interim data analysis from The NGAL Test study to support our pediatric application to the FDA. The results are consistent with our expectations and supports our view that The NGAL Test is an important biomarker for AKI in children. The focus is now to accelerate patient enrollment to finalize the study while at the same time continuing to explore the opportunities our technology hold in other areas.

Finally, I am very excited that we also shortly after the end of third quarter of 2021 appointed Tony as new CEO and Neil CFO in BioPorto. They bring tons of experience from the medtech industry to the table and will together with our dedicated employees be pivotal in realizing the huge potential of our products and platforms.”

Investor Meeting

In connection with the release of the Interim Report for the third quarter of 2021, BioPorto will host an online investor presentation on November 17, 2021 at 14:00 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, BioPorto A/S, + 45 45 29 00 00Tim Eriksen, Investor relations, BioPorto A/S, +45 61 68 77 79

Email: investor@bioporto.com

About BioPortoBioPorto 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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