November 19, 2025
Announcement no. 26
BioPorto Interim Result for the Third Quarter of 2025 – Continued progress and continued NGAL sales growth.
Copenhagen, Denmark, November 19, 2025, (GLOBE NEWSWIRE) – BioPorto A/S (“BioPorto” or the “Company”) (CPH:BIOPOR), today announced interim financial results for the third quarter of 2025, unchanged from the pre-announced Key Financial Results that were announced on November 4, 2025.
Highlights of key strategic milestones and a renewed strategy, “Forward”
- Delivery of the first ProNephro AKI™ (NGAL) order to the US market in August 2025, marking the first step in the commercial launch.
- At the end of October 2025, BioPorto successfully completed patient enrollment in its clinical cut-off study. As announced previously, the Company has decided to submit a pre-submission meeting request to the US Food and Drug Administration (FDA) once the dataset has been analyzed, now expectedly in Q1 2026. The clinical validation study is scheduled to begin following feedback from FDA, allowing BioPorto to proceed with a protocol aligned with FDA feedback. Accordingly, the FDA regulatory submission is postponed from the end of 2026 and into H1 2027.
- An updated strategy, “Forward” with focus on building market adoption, capturing high growth and expand addressable market was established. BioPorto’s purpose to “improve kidney health and quality of lives” remains intact.
- On November 13, 2025, BioPorto announced a fully subscribed private placement of 40,438,426 new shares at market price. The offering is expected to provide gross proceeds of approximately DKK 43 million.
Carsten Buhl, BioPorto’s Group Chief Executive Officer (CEO), comments:
“In the third quarter of 2025 we delivered the first US order of ProNephro AKI (NGAL) which marks the first step in building a commercial platform to drive broad adoption of ProNephro AKI through strategic distributors.
As we successfully completed patient enrollment and now are focusing on thorough data analysis, our commitment is to ensure the highest quality and most effective design for the validation study. While this means our FDA submission will shift into the first half of 2027, this approach derisks our design of the validation study.
Our “Forward” strategy 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.
Finally, on November 13, we successfully completed a share issuance, providing gross proceeds of approximately DKK 43 million. We greatly appreciate the strong support from both existing shareholders and new institutional and private investors, supplemented by a strong commitment from BioPorto’s Board and management. The proceeds are projected to cover spending throughout 2026 and thereby position the Company strongly for its journey towards positive cash flow in the second half of 2027. ”
Key Financial Results for the third quarter of 2025 and for the first nine months of 2025
- Revenue in the third quarter of 2025 totaled DKK 10.4 million, representing a 7% increase compared to the same period last year, and a 10% increase at constant exchange rates. For the first nine months of 2025 total revenue amounted to DKK 28.7 million, representing a 1% increase compared to the same period last year. At constant exchange rates the total revenue increased by 2%.
- For the third quarter of 2025, total NGAL sales totaled DKK 7.2 million, growing by 5% globally, and by 10% at constant exchange rates. For the first nine months of 2025, total NGAL sales rose by 5% compared to the first nine months of 2024 and by 7% at constant exchange rates.
- Adjusted EBITDA loss in the third quarter of 2025 amounted to DKK 16.8 million as expected, compared to DKK 19.6 million in the third quarter last year. For the first nine months of 2025 Adjusted EBITDA loss amounted to DKK 63.3 million, compared to DKK 51.1 million in the same period last year.
- As of September 30, 2025, the Company’s cash position was in line with expectations, DKK 27.6 million compared to DKK 77.1 million in the same period last year.
Guidance
Based on the results for the first 9 months of 2025, the full-year guidance for 2025 is unchanged compared to previously announcement on November 4, 2025 where the company revised the 2025 Guidance to:
- Total revenue is expected to be in the range of DKK 40-45 million.
- Adjusted EBITDA loss is expected to be in the range of DKK 75-80 million.
In connection with the release of the Interim Report for the third quarter of 2025, the Company will host an online investor presentation on November 19, 2025, at 11:00 CET via HC Andersen Capital. Investors interested in attending the webcast may register here: BioPorto – Presentation of Q3 2025 Interim Results
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Investor Relations Contacts
Niels Høy Nielsen, Chief Financial Officer, BioPorto A/S, investor@bioporto.com, C: +45 2551 8724
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 AKITM (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, with the Danish Financial Supervisory Authority, particularly under the heading “Risk Factors”.
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