Business Strategy Update – the “Forward” Strategic Direction, Aspirations towards 2028 and Funding Needs

November 4, 2025
Announcement no. 23

Business Strategy Update – the “Forward” Strategic Direction, Aspirations towards 2028 and Funding Needs

Copenhagen, Denmark, November 4, 2025, (GLOBE NEWSWIRE) – BioPorto A/S (“BioPorto” or the “Company”) (CPH:BIOPOR), today announced a business strategy update, aspirations towards 2028 and funding needed to support the business until cash flow positive in the second half of 2027. CEO Carsten Buhl will present the Business Strategy Update on an investor webcast on November 6 at 10:00 AM CET(registration below).

Following a review of the Company’s strategic direction, an updated plan “Forward” has been established.

BioPorto’s purpose is to improve kidney health and quality of lives of patients. The ambition is unchanged to succeed through actionable biomarkers and thereby transform kidney care globally. The “Forward” strategic plan is a three year plan focusing on building market adoption, capturing high growth and expand the addressable market.

2026	2027	2028
Build Market Adoption for BioPorto’s NGAL test	Capturing High Growth within the Addressable Market of USD 700m	Expand Addressable Market & Accelerate Growth
Increase market adoption in the US	Increase market adoption in the EU	Expand market adoption in the EU
Reach +60 active hospitals in the US	Reach +100 active hospitals in the globally	Reach +170 active hospitals in the globally
Initiate the clinical validation study for adults	FDA submission for adults by first half of 2027 & CE-mark under EU IVDR in 2027	Unlock broader market potential by targeting new patients’ segments

Carsten Buhl, BioPorto’s Group Chief Executive Officer (CEO) stated: “Our “Forward” plan represents a bold step in advancing our ambition to transform kidney care worldwide. By focusing our execution over the next three years, we are confident we can accelerate adoption, drive innovation, and improve outcomes for patients, all while staying true to our purpose.”

Strategic focus areas

To succeed in building market adoption, the Company will build on its US commercial execution, initiated in early 2025. The Company plans to strengthen its core competencies and expand business development resources to set up the organization for future growth.

U.S. hospital adoption is growing quarter over quarter, driven by expanding research use only (RUO) deployments and uptake following the end of 2023 FDA clearance of ProNephro AKI for pediatric use.

A key component in the Company’s commercialization strategy is to secure strategic partnerships with instrument manufactures and thereby drive product adoption. These collaborations will enable more laboratories to adopt and utilize BioPorto’s biomarker more rapidly. The goal is to have over 60 active hospitals across the US by the end of 2026.

To achieve high growth, the Company will apply US market learnings to its European go-to-market strategy. Growth efforts will focus on a few targeted European markets, utilizing clinical education and business development resources. Preparation for the EU IVDR certification is underway to meet anticipated demand and facilitate market growth. IVDR certification is expected in 2027.

Market penetration will continue in both pediatrics and adults’ segments, particularly as the future enhanced clinical guideline (KDIGO) is expected to gain traction and drive increased adoption. The goal is to reach over 100 hospitals actively using the Company’s products globally by the end of 2027.

To expand the addressable market, the Company intends to broaden its product portfolio, to address additional clinical settings where the NGAL biomarker is relevant. While the initial focus has been in intensive care units (ICU), BioPorto plans to expand into new areas through label expansion, product development through partnerships or own development to further improve kidney health and the patient’s quality of life. The goal is to have over 170 active hospitals globally by the end of 2028.

As a result, BioPorto’s aspirations towards 2028 have been updated

• Positive Cash Flow in the second half of 2027
• Revenue in FY 2028 between DKK 150-200 million
• Adjusted EBITDA-margin in FY 2028 of at least 15%
• The above aspirations replace the previously announced aspirations

Aspirations	Update – Nov 2025 (Replaces Feb 2024 aspirations)	Previously – Feb 2024
Cash Flow Positive	Second half of 2027	End 2026 at the earliest
Revenue	DKK 150-200 million FY 2028	USD 100 million FY 2029
Adjusted EBITDA-margin	+15% FY 2028	Neutral end 2026 at the earliest

Funding Needs

The Company aims to be cash flow positive in the second half of 2027, requiring an estimated DKK 60-70 million in funding.

The Company continues to evaluate financing alternatives, including share issuance and alternative financing solutions, to support the completion of the US clinical study for adults and further strengthen the commercial platform. The Company will announce process and timeline in the near future. 

Investor webcast will take place on November 6 at 10:00 AM CET

CEO Carsten Buhl will present the Business Strategy Update at a webcast for investors on November 6 at 10:00 AM CET.

Registration for the presentation is now open, and participants can submit questions in advance. Please register at the following link: https://hca.videosync.fi/2025-11-06-investor-event/register

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

For further information, please contact

Hanne S. Foss, Head of Investor Relations,  investor@bioporto.com, C: +45 26368918

Niels Høy Nielsen, CFO, investor@bioporto.com, C: +45 25518724

About BioPorto

BioPorto is an in vitro diagnostics company focused on saving patients’ lives and improving their quality of life with actionable kidney biomarkers – tools designed to help clinicians make changes in patient management. The Company leverages its expertise in 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 risk assessment and management of Acute Kidney Injury (AKI), 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 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 and FDA cleared ProNephro AKI^TM (NGAL) in the US.

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 statement disclaimer

Certain statements in this news release are not historical facts and may be forward-looking statements. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to the Company’s expectations, intentions and projections regarding its future performance including the Company’s Guidance for 2025; currency exchange rate fluctuations; anticipated events or trends and other matters that are not historical facts, including with respect to implementation of manufacturing and quality systems, commercialization of NGAL tests, and the development of future products and new indications; concerns that may arise from additional data, analysis or results obtained during clinical trials; and, the Company’s ability to successfully market both new and existing products. These forward-looking statements, which may use words such as “aim”, “anticipate”, “believe”, “intend”, “estimate”, “expect” and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks, and uncertainties that could cause the actual results of operations, financial condition, liquidity, dividend policy and the development of the industry in which the Company’s business operates to differ materially from the impression created by the forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Given these risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of such statements and, except as required by applicable law, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Factors that may impact BioPorto’s success are more fully disclosed in BioPorto’s periodic financial filings, including its Annual Report for 2024, particularly under the heading “Risk Factors”.

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• 2025 11 04 - Announcement No. 23 - UK