November 21, 2019
Announcement no. 21
Q3 2019 Report
Highlights
BioPorto to provide additional information for pediatric application for US regulatory clearance of The NGAL Test™
Following recent dialog with the US Food and Drug Administration (FDA), BioPorto on November 18, 2019 announced that it has decided to supplement its pediatric 510(k) application with additional data in order to fully respond to the most recent review shared by the Agency.
The valuable study from which BioPorto drew its original dataset demonstrated that the NGAL biomarker can be successfully deployed to assess risk of pediatric acute kidney injury (AKI) in the critical care setting. However, the FDA disagreed with the clinical community, expressing concern over risk of clinician bias in the data.
BioPorto will therefore build a follow-on dataset designed to demonstrate NGAL’s utility not only to clinicians, but also to FDA. BioPorto hence expects to submit a revised and supplemented application in Q2 2020.
NGAL in focus at ASN’s Kidney Week
Knowledge and awareness of NGAL as an early biomarker for AKI risk in critically ill patients is growing among nephrologists and physicians as more and more papers describing NGAL’s clinical applications are being published in medical journals.
During the world's premier nephrology meeting, called Kidney Week, arranged by the American Society of Nephrology in November 2019 in Washington D.C., AKI and NGAL were highlighted with two oral presentations, sixteen posters and abstracts and many discussions with thought leaders. BioPorto participated as a leading voice on the application of NGAL in early detection of AKI to prepare clinicians for the expected clearance and US launch of The NGAL Test.
The NGAL Test continues strong growth in the US
BioPorto’s revenue in the third quarter of 2019 grew by 24% to DKK 6.6 million compared to DKK 5.4 million last year. US revenues from NGAL grew by 29% in the quarter compared to the same quarter last year. This is primarily due to the focus on converting the growing interest in the potential uses for NGAL into sales of the Research Use Only (RUO) assay. Secondly, sales of antibodies remained positively affected by higher bulk orders.
BioPorto’s operating loss before interest and tax (EBIT) for the third quarter of 2019 was DKK 24.0 million compared to a loss of DKK 11.5 million last year in the same period. Ongoing build-up of the US organization, full-year effects of hiring in 2018 and costs related to ceased collaboration with a vendor are the main reasons for the increased loss.
Guidance for 2019 revised
As a consequence of the decision to provide additional information in support of its US application for regulatory clearance of the NGAL Test for pediatric risk assessment of AKI, BioPorto changed its financial guidance for 2019 to approximately DKK 29 million in revenue and EBIT loss of approximately DKK 70 million.
Peter M. Eriksen, CEO commented:
“On top of a good third quarter with satisfying growth in revenue and executing according to plan, we unfortunately had to announce a delay in our US pediatric application process for The NGAL Test. FDA saw some risk of bias in the data from the AWARE study, which we used in our application, which we must address. While this is of course disappointing in the short term, I believe the dialogue and feedback from FDA, along with the additional data we will collect, will strengthen our future commercial position and augment our ongoing adult studies. While we might have different views on the data, I truly appreciate the candid dialog with FDA and we remain committed to continue this process in order to address the significant unmet medical need for better tools, like The NGAL Test, that can help doctors evaluate and manage critically ill patients at risk of AKI.”
Investor meeting
In connection with the release of the interim report for the first nine months of 2019, BioPorto will host an investor meeting on November 21, 2019 at 3 pm CET. The meeting will be held at Tuborg Havnevej 15 st., 2900 Hellerup, Denmark. To attend the meeting, please sign up at investor@bioporto.com.
For further information, please contact:
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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