March 20, 2025
Announcement no. 06

BioPorto announces the Annual Report for 2024

Copenhagen, Denmark, March 20, 2025, (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), today announces the annual financial results for 2024.

Peter Mørch Eriksen, BioPorto’s Group Chief Executive Officer (CEO), comments

• It is with great enthusiasm that I reflect on the remarkable milestones achieved by BioPorto in 2024 – a year marked by significant accomplishments and strategic progress. We have focused on establishing a strong commercial platform. Our efforts have yielded promising results, including the first standing order from a US hospital and representation in 9 out of the top 10 best children's hospitals. These achievements are a direct result of the dedication of our employees, the unwavering support of our customers and collaborators, and the confidence our investors have in our growth strategy.

Key strategic achievements for FY 2024

• We strengthened our commercial setup, particularly in the US, by adding sales staff and medical liaisons to drive an increase in demand for NGAL products.
• A new partnership with Beckman Coulter, a leading global life sciences diagnostics innovator, was signed towards the end of the year, which expands our commercial reach and marks a key milestone.
• The first US standing order with a yearly value of more than USD 200,000.
• The ProNephro AKI (NGAL) study for adult use commenced in early 2024, with a goal to submit an application to the FDA by the end of 2026. Key milestones have been met, including the enrolment of the first patient ahead of schedule in October 2024.
• Successful completion of an oversubscribed direct issue of USD 11.7 million (DKK 81.4 million*) in June 2024.

Financial highlights for FY 2024                                                                                                                            

• Total revenue of DKK 36.2 million – a 17% growth compared to 2023.
• NGAL revenues in the US increased by 34% compared to 2023 – global NGAL revenues increased by 24% compared to 2023 and accounted for 64% of the total revenue.
• Adjusted EBITDA loss in 2024 amounted to DKK 70.6 million, which is in the middle of the revised guidance of DKK 68-73 million communicated January 6, 2025.
  

Guidance for 2025

As announced on March 19, 2025, BioPorto is targeting total revenue of DKK 45-60 million, corresponding to a growth in the range of 24-66% compared to 2024. Growth will be driven by increased ProNehro AKI (NGAL) sales, especially in the US. Revenue in 2025 is expected to be back-end loaded.

For 2025, an adjusted EBITDA loss in the range of DKK 75-85 million is expected which corresponds to an increase of 6-20% compared to 2024. The higher expected loss is a result of higher sales and marketing costs for ProNephro AKI (NGAL) primarily in the US and the cost of clinical trials to support FDA clearance for ProNephro AKI (NGAL) for adults.

For 2026, BioPorto aspires to reach total revenue of DKK 80-125 million (app. USD 12-18 million). In addition, cash flow is expected to be positive and EBITDA neutral by the end of 2026 at the earliest. It is BioPorto’s aspiration to reach and exceed DKK 700 million (app. USD 100 million) in total revenue by 2029.

The revenue growth will be contingent on the following key levers:

• Kidney damage biomarkers included in the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines in the first part of 2026.
• Entered strategic partnerships with the remaining three of the "Big 5" clinical chemistry instrument vendors, and ProNephro AKI (NGAL) commercialized on their key instruments.
• ProNephro AKI (NGAL) approved for adult use by FDA in 2027.

*) DKK/USD Exchange Rate app. 7.00

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Webcast

The Company’s management team will host a webcast today at 10:00 AM CET for investors and analysts to present the full year results following a Q&A session.

The webcast is hosted by HC Andersen Capital, please register here to join the call.

Investor Relations Contacts

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

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 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, with the Danish Financial Supervisory Authority, particularly under the heading “Risk Factors”.