BioPorto Announces the 2019 Annual Report

BioPorto Announces the 2019 Annual Report

March 11, 2020

Announcement no. 3

BioPorto is focused on submitting the FDA application for pediatric use of The NGAL Test™

Highlights from the 2019 Annual Report

• Submission of supplemented US application for The NGAL Test for pediatric use expected in Q2 2020
• Political and policy support builds awareness of kidney health in the US
• Strong commercial, clinical and regulatory additions to the US organization
• Continued growth in revenue for The NGAL Test from research use

The year 2019 was important for BioPorto as the company made progress towards two strategic milestones:  first, expanding awareness of NGAL as an early and important biomarker for the detection of acute kidney injury (AKI); and second, achieving Breakthrough Designation from the FDA for The NGAL Test application for pediatrics. This was the first pediatric IVD Breakthrough Designation awarded by the FDA in many years.

“Our efforts to increase awareness of NGAL for the diagnosis of AKI were bolstered by the US government’s attention on kidney health initiatives. These were catalyzed by a White House executive order to invest in education as well as in therapeutic and preventative measures that will improve the lives of patients with kidney disorders. We expect this focus on the kidney will ultimately support the case for NGAL and the need to address the challenges of AKI”, said Peter Mørch Eriksen, CEO of BioPorto.

FDA application of The NGAL Test based on additional data to be submitted in Q2 2020

Having submitted an FDA application for The NGAL Test for risk assessment for AKI in pediatric patients and obtained Breakthrough Designation in 2019, BioPorto learned in November 2019 that the Agency was concerned about potential bias in the dataset on which the application was based.

“While we, and the authors of the publication, as well as other leading nephrologists, disagreed with the Agency’s concern about bias in the study design, we decided to supplement our application with additional data in order to fully address the matter. The design and execution of the study for the revised application is BioPorto’s single most important task in 2020. Leading this process is our new and experienced US clinical and regulatory team. We have already initiated a pre-submission dialogue with FDA, and expect to submit a revised pediatric application in Q2 2020”, Mr. Eriksen commented.

Collection of data and growing NGAL revenues in 2020

In addition to collecting additional data for the pediatric FDA application, BioPorto expects to continue to increase NGAL revenue and will also evaluate new product opportunities in 2020. “We anticipate double-digit NGAL sales growth this year, not including new revenue from any FDA cleared test. As we look ahead, we are also planning for long term growth by assessing new indications and opportunities for both NGAL and for our antibody library.  New products based on our core technology will be key to developing a robust pipeline of targeted antibodies and biomarkers to fuel BioPorto’s future expansion”, Mr. Eriksen explained.

Financial market reactions to COVID-19 affects timing of the funding process

As announced in Announcement no. 1/2020 on February 26, 2020, BioPorto is pursuing additional financing to strengthen the company’s financial position and to support the execution of its strategy.

While it was the Company’s ambition to finalize the financing prior to the announcement of the Annual Report 2019, recent increased volatility and negative reactions in the financial markets caused by the global outbreak of the COVID-19 virus has delayed the financing timeline. BioPorto now expects the financing to be finalized by mid-April 2020.

The content of this announcement does not alter BioPorto’s financial guidance for 2020, which was recently presented in the preliminary financial results for 2019.

Selected Financial Highlights 2015-2019

For further information, please contact:

Peter Mørch Eriksen, CEO

Ole Larsen, CFO

Telephone , e-mail:

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].

Forward-looking statements

This announcement contains certain forward-looking statements, including with respect to the U.S. regulatory approvals process of BioPorto’s NGAL Test, The Company’s proposed financing and BioPorto’s, anticipated financial results for 2020. Although BioPorto believes that its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this company announcement about future events are subject to (i) change without notice and (ii) factors beyond BioPorto’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could”, and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond BioPorto’s control that could cause BioPorto’s actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. Except as required by law, BioPorto assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

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