BioPorto Announces Annual Report 2018

February 22, 2019

Announcement no. 2

Annual Report 2018

Full speed ahead

Highlights from the Annual Report 2018

• Revenue growth of 80% from sales of The NGAL Test™ in U.S. and 18% in rest of the world in 2018
• Total revenue of DKK 26 million in 2018 and an operating loss of DKK 42 million
• Initiation of two separate FDA approval processes for The NGAL Test™ for risk use with AKI in children and adults
• Focus on building knowledge of NGAL continues with great force and success
• Revenue in 2019 expected at approximately DKK 40 million with an expected operating loss of DKK 45 million

2018 was another event full year in BioPorto. A year characterized by a high level of activity and strong successes in increasing knowledge, performance and potential for The NGAL Test™. But also by disappointment when the U.S. Food and Drug Administration (FDA) required further data to support clearance of the test in the U.S. A clearance, which is now expected in the second half of 2019.

“2018 was a very busy year in BioPorto. We have undertaken clinical studies in the U.S., strengthened the organization, participated at conferences and increased sales of The NGAL Test™ for research use only in the U.S. by 80% over last year. Furthermore, we continued the targeted task of increasing focus among patients, physicians and politicians on the huge unmet needs in health care for the NGAL technology to provide safer and more efficient diagnosis and treatment of AKI. Indeed, we have been successful in these efforts,” Mr. Peter Mørch Eriksen, CEO of BioPorto, says.

Two applications for The NGAL Test™ to be submitted to FDA in 2019

The support from patient organizations, partners, physicians and regulatory authorities to expand the application of the NGAL platform has been very strong in 2018. This has led to a broader scope for The NGAL Test™.

“On back of the strong interest and opportunity to conduct a fast and efficient study initiated a FDA approval process for The NGAL Test™ for risk use with AKI in children under the age of 21. It will be based on NGAL in urine samples, whereas the application for adults is based on measurements in plasma. Obtaining FDA clearance for the test in children will be very important both for patients and hospitals, as it will make the test available to American pediatric hospitals and clinics much faster than if the hospitals were to secure approval individually. In addition, separate FDA clearances for children and adults in both urine and plasma will strengthen BioPorto’s strategic position on the global market considerably,” Mr. Eriksen points out.

Focus on growth and strategic execution in 2019

BioPorto’s focus in 2019 will be on strategic execution and increasing revenue by 50% to approximately DKK 40 million. The driving force will be growing sales of The NGAL Test™.

“2019 will be very important to BioPorto. We will focus even harder on the U.S., by allocation even more resources to the development of this important market. Specifically, we will conclude, submit and hopefully obtain clearance of the two FDA applications for The NGAL Test™. In addition, we will accelerate the expansion of our commercial organization in the U.S. to propel awareness and interest to higher levels and hence increase sales of the test,” Mr. Eriksen concludes.

Selected Financial Highlights 2014-2018

For further information, please contact:

Karen Stendal, Legal Counsel
Telephone +45 4529 0000, e-mail investor@bioporto.com

Attachment

• Annual Report 2018