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Beskrivning

LandDanmark
ListaSmall Cap Copenhagen
SektorHälsovård
IndustriLäkemedel & Handel
BioPorto är verksamt inom bioteknik. Bolaget tillverkar och marknadsför tester för diagnostisering av allvarliga sjukdomar. Produktportföljen består av egenutvecklade antikroppsläkemedel som används för farmaceutisk bruk samt inom diverse forskningssammanhang. Produkterna återfinns på global nivå och används exempelvis vid behandling och analys av fetma, diabetes och diverse allergier.

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2026-02-05 21:01:13

February 5, 2026
Announcement no. 1

BioPorto provides Preliminary Unaudited 2025 Financial Figures, Financial Guidance for 2026 and a Business Update                                                                        

COPENHAGEN, DENMARK, February 5, 2026, (GLOBE NEWSWIRE) – BioPorto A/S CVR-no. 17500317 (BioPorto or Company) (CPH:BIOPOR), today announced Preliminary Unaudited 2025 Financial Figures, Financial Guidance for 2026 and a business update.                                         

A strong quarter to close out the year - Preliminary Financial Figures for the Fourth Quarter of 2025 and Fiscal Year 2025

  • In the fourth quarter of 2025, BioPorto’s revenue amounted to DKK 11.6 million, corresponding to an increase of 47% versus prior year, and a 52% increase at constant exchange rates. The very strong growth was primarily driven by NGAL (Research Use Only (RUO)) in the US and revenue from strategic distributors. Revenues from strategic distributors can be lumpy, and it remains premature to assume a steady quarterly cadence of this revenue stream.
  • Revenue for the 2025 financial year amounted to DKK 40.3 million, compared to DKK 36.2 million in the previous year, representing a revenue growth of 11%, and at constant exchange rate a growth of 13%. The growth was strongly driven by NGAL RUO in the U.S. growing 25% to DKK 18.4 million, and 29% at constant exchange rates. Further, revenues from strategic distributors of NGAL contributed by additional DKK 4.3 million. Total NGAL share of the total revenue amounted to 70%. The preliminary revenue for the 2025 financial year is within the latest disclosed guidance of DKK 40-45 million.
  • The full year adjusted EBITDA for 2025 is estimated to end at a loss of app. DKK 77 million and within the latest disclosed guidance of a loss of DKK 75-80 million.
  • As of December 31, 2025, the Company’s preliminary cash position was app. DKK 55 million compared to DKK 59.7 million as of December 31, 2024.

Preliminary figures for 2025:

(DKK million)Q4 2025Q4 2024Change (Pct)FY 2025FY 2024Change (Pct)Latest Guidance
Total Revenue11.67.947%40.336.211%40-45
Total NGAL Revenue8.94.888%28.223.122%N/A
U.S. NGAL Revenue (RUO)4.93.539%18.414.725%N/A
Adj. EBITDA lossApp. 13.719.4-29%App. 77.070.68%75-80

Carsten Buhl, CEO of BioPorto, comments: “I am satisfied with the preliminary results for 2025 delivering on the latest guidance. We keep executing on our “Forward” strategy and growing the NGAL business. We saw a very strong top-line growth in NGAL in the fourth quarter of 2025, which was helped by a larger bulk order to our strategic distributor, while also showing very strong growth in the U.S. from RUO (Research Use Only).”   

The above amounts are preliminary and unaudited.

BioPorto is scheduled to release its Annual Report for 2025 on March 26, 2026.

Guidance for 2026

For 2026, the total NGAL revenue is expected to grow 20-50% and reach DKK 33-42 million. Further, as per our “Forward” strategy plan, we are pursuing +60 active hospitals in the US in 2026. Growth will be driven by increased ProNephro AKI (NGAL) RUO sales in the U.S.

For the total revenue BioPorto is targeting DKK 48-58 million for 2026, corresponding to growth in the range of 20-45%. Revenue for the year is expected to be back-end loaded as the expected number of active hospitals gradually increases.

The adjusted EBITDA loss for 2026 is expected to be in the range of DKK 50-60 million, which corresponds to a decrease in loss between 22-35%. The expected improvement in adjusted EBITDA is a result of higher revenues and reduction in the overall cost base compared to prior year, including an expectation that the validation study will go across 2026 and into the first half of 2027 as previously announced.

Guidance for 2026:

(DKK million)FY 2026Change (Pct)
Total Revenue48-5820-45%
Total NGAL Revenue33-4220-50%
Adj. EBITDA loss50-60(22-35)%

The aspirations for 2028 stay unchanged with Revenue in FY 2028 between DKK 150-200 million and Adjusted EBITDA-margin of at least 15%. Further, the expectation for the Cash Flow also remains unchanged as the Company expects Cash Flow to become positive in the second half of 2027. The current Cash at hand is still expected to cover projected spending through 2026. The Company’s range of future financing options continues to be matured to secure funding for 2027, in the form of potential divestments of non-core assets supplemented with credit facilities and other financing solutions. 

The guidance is based on DKK/USD Exchange rate of 6.35.

Business Update – Continued Execution on the “Forward” Strategy

On November 4, 2025, BioPorto presented an updated plan “Forward” to the strategic direction towards 2028. For 2026, the focus is to Build Market Adoption for BioPorto’s NGAL test, which means:

  • Continuing market adoption in the US – for 2025, the groundwork for a broader and increased market adoption has been established. We have seen good progress in advancing NGAL for Research Use Only (RUO). BioPorto’s strategic segmentation and focus on children’s hospitals continued to demonstrate value in 2025. The U.S. hospital adoption is growing quarter over quarter. By the end of 2025, there were 44 active hospitals based on RUO, 8 more than at the end of 2024. This is setting up the Company for a target of +60 active hospitals in the U.S. by end of 2026.
  • Preparing for the clinical validation study for adults – BioPorto is currently in the final phase of preparing for the database lock as part of the cut-off study for adults. Following the database lock in Q1 2026, the Company will conduct the in-depth data analyses needed to design the validation study. Ahead of study initiation, the Company will submit a pre-submission package to the U.S. Food and Drug Administration (FDA), which represents the next critical milestone and is expected end of Q1 2026.The validation study is currently anticipated to be similar in scope and size to the cut-off study, and therefore the final regulatory submission remains expected by the end of H1 2027.

Carsten Buhl, CEO of BioPorto comments: "Our Forward plan sets the direction for the entire Company and holds the key elements in driving both short and long-term growth for BioPorto. Entering 2026, we have several milestones related to commercial traction as well as the progress on our adult study. We look forward to sharing the commercial progress in our quarterly reporting and the milestones related to adult study. Certainly, an interesting year ahead and I really look forward to bringing NGAL out to many more hospitals and patients!”

In connection with the release of the above announcement, the Company will host an online investor presentation on February 6, 2026, at 2:00 PM CET via HC Andersen Capital. Investors interested in attending the webcast may register here: https://hca.videosync.fi/2026-02-06-investor-prsentation/register.

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

Investor Relations contacts

Niels Høy Nielsen, BioPorto A/S, [email protected], C: +45 45290000

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”.

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.