BioPorto (NASDAQ COPENHAG:BIOPOR) A/S has posted third-quarter results that saw strong sales of antibodies, ELISA kits and research- use-only (RUO) sales of its flagship NGAL Test, which provides early risk assessment of acute kidney injury (AKI), a complication that is common after surgeries such as kidney transplants and heart-bypass.
In the first nine months of 2021, the in vitro diagnostics company, which is headquartered in Hellerup, Denmark said its revenue grew by 11% in Danish krone and 19% in US dollars.
For the third quarter ended 30 September, 2021, BioPorto said ELISA kit sales also “contributed to topline performance” which grew 12% in Danish krone and 13% in US dollars.
READ: BioPorto extends enrollment for clinical trial on moderate to severe acute kidney injury into first half of 2022
Based on developments so far, BioPorto said it expects to narrow its EBIT, or earnings before interest and tax loss for 2021 from around 73 million Danish krone (US$11.11 million) to around 63 million Danish krone (US$9.59 million).
Significantly, the revised EBIT guidance will have a positive effect on BioPorto’s cash position by the end of 2021. “The company based on the current outlook expects to have funding into third-quarter 2022 whereas previously estimated to second quarter 2022,” noted BioPorto .
For the financial year 2021, BioPorto (NASDAQ COPENHAG:BIOPOR) has adjusted expectations for revenue to around 24 million Danish krone (US$3.65 million) from its previous guidance of 30 million Danish krone (US$ 4,56 million).
In a statement accompanying the numbers, BioPorto (NASDAQ COPENHAG:BIOPOR) CEO Peter Mørch Eriksen said: “As in previous quarters, we have seen a satisfying development in our activities in 3Q 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 the 3Q received the interim data analysis from The NGAL Test study to support our pediatric application to the US Food and Drug Administration (FDA). The results are consistent with our expectations and support our view that The NGAL Test is an important biomarker for AKI in children.”
Eriksen noted that the focus now is to “accelerate” patient enrollment to finalize the study, while at the same time continuing to explore the opportunities the company’s technology potentially holds in other areas.
“Finally, I am very excited that we also shortly after the end of 3Q 2021 appointed Tony as new CEO and Neil CFO in BioPorto (NASDAQ COPENHAG:BIOPOR),” said Eriksen. “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.”
After a successful search process, BioPorto in October 2021 announced the appointments of Anthony (Tony) Pare as its new CEO and Neil A. Goldman as new Executive Vice President and CFO. They will be joining BioPorto from global medtech companies by mid-November 2021. The two executives will bring decades of experience to BioPorto in launching products, growing businesses and raising capital, added the company.
Earlier in November, 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. In addition, Peter Mørch Eriksen was elected as a member of the board of directors.
The company highlighted that in August, 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. 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 the quarter, patient enrollment for the pediatric study has been impacted and delayed by the continuation of the pandemic. BioPorto said it now expects to finalize data collection during the first half of 2022.
Meanwhile, BioPorto has advanced the dialogue with the 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 coronavirus (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,” said the company.
BioPorto will host an online investor presentation on November 17, 2021, at 14:00 CET in Danish and at 16:00 CET in English.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive