BioPorto (NASDAQ COPENHAG:BIOPOR) A/S said its total revenue for 2021 increased by single digits year-over-year.
The Danish company said it generated DKK 24.3 million in revenue -- representing growth of 4.5% compared to the prior-year period as it advances its flagship product The NGAL Test, which has been designed to aid in the risk assessment of Acute Kidney Injury (AKI).
Looking ahead to the rest of 2022, the company said it expects revenue of DKK 24-26 million.
READ: BioPorto issues update on pipeline for its gRAD technology
But looking back to 2021, the company said it achieved a few milestones -- including completing an interim analysis of The NGAL Test’s performance that were consistent with expectations.
However, enrollment for a pediatric trial for The NGAL Test continued but was delayed by the impact of COVID-19 on access to trial sites and patients. The company needs the trial for an eventual US Food and Drug Administration submission for pediatric use.
“But 2021 was also a year of progress for BioPorto (NASDAQ COPENHAG:BIOPOR) that will drive value creation in 2022 and onwards – particularly in the progression of R&D, validation, regulatory, quality and operational improvement efforts,” the company said in a statement.
“Furthermore, with the appointment of a new experienced executive team with a successful track record from introducing new diagnostic products to the US market, BioPorto (NASDAQ COPENHAG:BIOPOR) developed a clear strategic path for the future.”
BioPorto said it continues to expect to finalize enrollment of pediatric patients at 15 hospitals across the US by the second quarter of 2022 and subsequently submit for FDA approval of the test for use in identifying children at risk for AKI. Following submission, and in parallel with FDA review, BioPorto will initiate the application process for FDA approval of The NGAL Test for adult use in the US.
In other major moves during 2021, BioPorto appointed a new executive management team, board chairman, and board vice-chairman.
Since taking over as the CEO in November 2021, the company said Tony Pare has worked to focus BioPorto’s strategy on delivering the NGAL biomarker as the new standard of care in the assessment of kidney health, preparing the company to commercialize and scale, and building a strong team dedicated to the mission.
“We are a small company with a unique technology and very high ambitions. That calls for clear prioritization and focus on what we aim to achieve in the next 12-18 months, which is to obtain US FDA approval of our flagship product, The NGAL Test, for use in pediatrics (under age 22) and drive its adoption in the US, which is the largest market for in vitro diagnostic tests in the world,” Pare said.
Strong balance sheet
BioPorto also said it has a strong balance sheet to execute its plans for 2022 and beyond. As a first step of the strategy, BioPorto in March 2022 closed a fully subscribed, pre-emptive rights offering for new shares as part of a long-term capital plan that includes a potential US listing.
“The proceeds from the offering of approximately DKK 100.4 million will, together with existing funds, provide a strong foundation for submission of The NGAL Test application for pediatric use to the FDA, enable us to prepare for a commercial launch, and implement programs to drive market adoption,” Pare said.
“I am very thankful for the support and clear mandate from both existing shareholders and new investors to focus our efforts and execute this strategy. It is a strategy that I firmly believe will bring BioPorto to a very successful and bright future with compelling value creation for patients, health care providers, and our shareholders.”
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