August 19, 2020
Announcement no. 15
Q2 2020 Report
Strong Revenue Growth of 81% for The NGAL Test™
Research use only (RUO) sales of The NGAL Test™ nearly doubled in Q2 2020 compared to the same quarter of 2019 and product sales of The NGAL Test in the rest of the world (ROW) grew by 85% year-on-year. Global growth was driven by increased orders from current customers, both direct and distribution, as well as sales to new customers.
In total, product sales of The NGAL Test increased to DKK 7.1 million in the first half of 2020. This growth is encouraging and is expected to continue in the second half of 2020.
Patient Enrollment for US Pediatric Clinical Trial Initiated
BioPorto has begun enrollment of pediatric patients in its US clinical trial of The NGAL Test for the risk assessment of acute kidney injury (AKI) in critically ill children. The Company reiterates its expectation of completing the trial and filing a De Novo application for US regulatory clearance of The NGAL Test in the second half of 2020.
CE Mark of NGALds for Near-Patient Testing Expected in Late 2020
BioPorto has initiated a self-declaration (CE Mark) in the EU of its novel NGALds, the first assay developed on BioPorto’s proprietary gRAD lateral flow platform. The NGALds is a rapid test that requires no instrumentation, and therefore is ideal for near-patient settings, such as physician offices and clinics, where an immediate result is of significant value.
Pilot Testing of gRAD-Based Test for COVID-19 Expected in Q3 2020
BioPorto and the University of Southern Denmark (SDU) have partnered to co-develop a test for early, rapid detection of SARS-CoV-2 infection in patients. The test is designed to use novel SDU antibodies with BioPorto’s patented gRAD technology to create a dipstick point-of-care test that can detect the SARS-CoV-2 virus from a sample in under 10 minutes. Pilot testing in the US could begin as soon as Q3 2020, and if successful could lead to commercial availability before the end of the year, following the FDA’s Emergency Use Authorization (EUA) process.
Further Capitalization of BioPorto is Planned
In early April, BioPorto completed a fully subscribed rights issue with net proceeds of DKK 37.9 million. To further strengthen its financial position, BioPorto expects to initiate and complete an offering of new shares in the second half of 2020. BioPorto has engaged Nordea as financial advisor for this process.
Guidance for 2020 Maintained
BioPorto maintains its financial guidance for 2020, as most recently described in its Interim Report for the first 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:
“In very disturbing and difficult times that have been heavily influenced by the COVID-19 pandemic, I am extremely glad that the employees of BioPorto and their families have remained safe and healthy. While this was critical in the first half of 2020, I am also very proud that we also actively engaged in deploying our technology and expertise, particularly leveraging NGAL and the gRAD platform. We are working hard to transform these efforts into new products that could contribute to the fight against COVID-19 and help to minimize impacts to patients and health systems, potentially as soon as later this year.
While COVID-19 has certainly changed the global agenda, BioPorto continued to diligently and successfully execute our long-term strategy in Q2 2020. In April we raised DKK 37.9 million in new capital with strong support from our shareholders. In June, we announced the enrollment of the first pediatric patient in the US clinical trial of The NGAL Test, following the end of a COVID-induced pause in global clinical studies. And today, we report very satisfying growth and record-high sales of The NGAL Test due to increasing orders from global distributors and customers. In a world characterized by limited visibility and higher uncertainty, I feel confident that BioPorto has never been better positioned to take on the tasks and realize the possibilities ahead of us.”
In connection with the release of the Interim Report for the first half of 2020, BioPorto will host an online investor presentation on August 19, 2020 at 15:00 CET in Danish and at 16:00 in English. For further information regarding the online investor meeting, please visit www.bioporto.com.
For further information, please contact:
Peter Mørch Eriksen, CEO
Ole Larsen, CFO
Telephone +45 4529 0000, e-mail: firstname.lastname@example.org
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].