April 4, 2024

Announcement no. 05

BioPorto Announces Annual Results for 2023

COPENHAGEN, DENMARK and BOSTON, MA, USA, April 4, 2024, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto or Company) (CPH:BIOPOR), an in vitro diagnostics company focused on empowering the early detection of Acute Kidney Injury (AKI), announced today financial results for the year ended December 31, 2023.

Highlights 2023
Revenue and adjusted EBITDA in 2023 are in line with the preliminary results announced on February 22, 2024. Revenue amounted to DKK 31m (USD 4.5m), equivalent to a 7% increase over 2022, and the adjusted EBITDA loss amounted to DKK 56m (loss of USD 8.1m)

As of December 31, 2023, the Company had cash and cash equivalents of DKK 66m (USD 9.8m).

Outlook for 2024
As announced on February 22, 2024, the expected revenue in 2024 is DKK 40m (USD 6m) corresponding to a growth rate of 30%.

Growth is expected to be driven by increased sales of NGAL products – primarily in the US following the FDA clearance, supplemented by growth in the rest of the world. Revenue is expected to be back-end loaded, as US clinical commercialization of ProNephro AKI (NGAL) will commence in the second half of 2024.

For 2024, an adjusted EBITDA loss in the range DKK 75-90m (loss of USD 11-13m) is expected. The expected loss relates to higher marketing costs for ProNephro AKI (NGAL) in the US, and the cost of new clinical trials to support FDA clearance for ProNephro AKI (NGAL) in adults.

Peter Mørch Eriksen, BioPorto’s Chief Executive Officer, comments: “Reflecting on 2023, the most important milestone for BioPorto was undoubtedly the FDA clearance received in December for ProNephro AKI (NGAL) for pediatric and young adult use. The NGAL test is designed to help doctors identify intensive care unit (ICU) patients at risk of developing acute kidney injury (AKI) earlier than current standard care, which allows for prompt intervention and saving lives. The FDA clearance is a major proof of concept and defining for the future of BioPorto.”

Peter Mørch Eriksen continues: “The growth in 2023 revenues is the results of a 25% increase in sales of our NGAL products for research use only in the US and for general use in Europe, Canada, Israel, South Korea and other markets where the test is CE marked. Throughout the year, we maintained tight control over costs and adjusted the organization to the leanest possible structure whilst awaiting the outcome of the FDA application.”

“In February 2024, we launched our updated strategy plan laying the foundation for our strategic objectives and a detailed action plan for the next 3-5 years. The central elements of our strategy are to secure commercial traction in the US for clinical NGAL testing of pediatric and young adult patients, increase the sales of NGAL for adult use in CE marked countries, and initiating and submitting US FDA application for clearance of NGAL for adult use. I am happy to report that we are progressing according to plan; we have taken the first important steps in the instrument expansion plan, we have finalized the draft protocol for the FDA application of ProNephro AKI for adults and we have strengthened our US organization ahead of the commercialization of ProNephro AKI for pediatric and young adult use which will be initiated in second half of 2024, ” Peter Mørch Eriksen concludes.

Conference Call and Webcast
The Company’s management team will host an online investor presentation on April 4, 2024, at 10:00 am CET via HC Andersen Capital. Investors interested in attending the webcast may register at: BioPorto - Helår 2023 og forventninger til 2024 - Inderes

To receive BioPorto’s Company Announcements, Press Releases, Newsletters and other business relevant information, please sign up on https://bioporto.com/investor-contact/.

For inquiries, please contact

Investor Relations
Claus Thestrup, HC Andersen Capital, +45 4529 0000, investor@bioporto.com
Ashley Robinson, LifeSci Advisors, +1 617 430 7577, arr@lifesciadvisors.com

About Acute Kidney Injury
Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in blood and makes it difficult for kidneys to maintain the proper balance of bodily fluids. AKI can also affect other organs such as the brain, heart, and lungs and is common in patients who are in hospital intensive care units. For more information about AKI please visit: https://bioporto.com/aki/.

About BioPorto
BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management. The Company uses its expertise in antibodies and assay development, as well as its platform for assay development, to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company’s tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem.

The Company’s flagship products are based on the NGAL biomarker and designed to aid in the risk assessment and diagnosis of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide.

BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com.

Forward-looking Statements
This announcement contains certain forward-looking statements. Words such as “initiate”, “may”, “focus”, “design”, “guide”, “plan”, “estimate”, “expand”, “target”, “potentially”, “will”, “should” and similar expressions identify such forward-looking statements, and such forward looking statements include statements with respect to commercialization activities in the U.S. and elsewhere, our collaboration with Roche Diagnostics GmbH (Roche), our ability to obtain regulatory approval to expand indications to analyzers other than the cobas c 501 or to other age groups and/or clinical indications, the buildout of our commercialization team and our financial guidance. Forward-looking statements involve risks, uncertainties and other factors, which may cause actual results, performance and achievements to differ materially from those contained in the forward-looking statements. These include numerous assumptions, risks and uncertainties, many of which are beyond BioPorto’s control. These assumptions, risks and uncertainties are described from time to time in BioPorto’s public announcements, its Interim Reports, and in its 2023 Annual Report under Risk Factors. BioPorto undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date of this presentation, except as required by applicable law.