BioPorto announces Interim Result for the First Quarter of 2026

May 21, 2026
Announcement no. 11

BioPorto announces Interim Result for the First Quarter of 2026

Copenhagen, Denmark, May 21, 2026, (GLOBE NEWSWIRE) – BioPorto A/S CVR-no. 17500317 (BioPorto or Company) (CPH:BIOPOR), today announced Interim financial results for the first quarter of 2026.

Carsten Buhl, BioPorto’s Chief Executive Officer (CEO), comments “We have kicked off 2026 in line with our plan. We divested our antibody business and thereby further sharpened our focus on NGAL and strengthened our financial position. We have solid revenue growth driven by increasing adoption of our NGAL products, particularly in the U.S. Research Use Only (RUO) market. Further, we now have the KDIGO’s draft 2026 guideline, that reinforces the global shift toward earlier identification and intervention related to acute kidney injury. And we have submitted our Food and Drug Administration (FDA) pre-submission package, marking an important step toward a future U.S. 510(k) clearance for the adult urine NGAL. All in all, a good quarter, and we remain on track with our Forward Strategy.”

Financial highlights                                                

• For Q1 2026, total NGAL revenue increased to DKK 6.0 million, which is an 33% increase compared to Q1 in 2025 (48% at constant exchange rate (CER)). The growth was driven by an increase in US NGAL Research Use Only (RUO) sales.
• For Q1 2026, revenue amounted to DKK 9.4 million (DKK 7.7 million for the same period in 2025). Revenue increased by 23% (32% at CER) in Q1 2026 compared to Q1 in 2025, and is mainly driven by US NGAL RUO and NGAL distributors revenue.
• Adjusted EBITDA loss in Q1 2026 amounted to DKK 17.9 million, which is a decrease of 36% compared to adj. EBITDA loss in Q1 2025 of DKK 28.1 million, and in line with expectations.
• As of March 31, 2026, the Company’s cash position was DKK 39.6 million compared to DKK 54.9 million as of December 31, 2025.
• Guidance for 2026 remains unchanged as announced April 8, 2026. The Company therefore expects total revenue of DKK 38-48 million, total NGAL revenue of DKK 33-42 million, and Adjusted EBITDA loss of DKK 58-68 million in 2026.
  
  

Key strategic achievements for Q1 2026

• Filed pre‑submission package with the U.S. Food and Drug Administration (FDA). This marks an important regulatory milestone for the Company and follows the positive preliminary analysis recently completed for the U.S. adult urine NGAL Cut‑off Study.
• Four new university hospitals for Research Use Only on-boarded in the US, bringing the total to 48 by end of Q1 2026, and on plan to achieve at least 60 US hospitals by end of 2026.
• New CFO, Klaus Juhl Wulff, was appointed, succeeding Niels Høy Nielsen effective end Q1.
• Consolidated Research & Development function in Denmark, under leadership of new CSO, Jakob Felding. 
• Kidney Disease: Improving Global Outcomes (KDIGO) published end March 2026 updated Clinical Practice Guideline Draft for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD).
  
  

Commentary Q1 2026

For 2026, the Company has chosen to change its quarterly reporting, so that for Q1 and Q3 the format will be a business trading update, and no longer contain a full profit and loss statement, balance sheet and cash flow statement. For half- and full-year reporting, the Company will continue the setup from previous years with detailed profit and loss statements, balance sheets, and cash flow statement reporting.

The financial results for the first quarter of 2026 shows a 23% increase in revenue to DKK 9.4 million, mainly driven by growth in US NGAL RUO. The adjusted EBITDA loss was DKK 17.9 million, compared to a loss of DKK 28.1 million, in the same period last year. The cost base in the first quarter of 2026 still includes high costs for the clinical study. The adjusted EBITDA result for the quarter is in line with expectations.

In the first quarter of 2026, the focus has been on executing on the Forward Strategy presented on November 4, 2025. We have experienced good progress on the projects across the organization.

Commercially, focus continues to be on increasing traction for investigating and use of NGAL as a research use only product; especially in the US market. During the first quarter of 2026, the Company onboarded 4 new US hospitals and its pipeline supports the full year plan to achieve 60+ US hospitals at the end of 2026.

Sales through distributors developed in line with expectations in the first quarter of 2026. However, revenue from strategic distributors can be uneven, and it remains premature to assume a steady quarterly cadence of this revenue stream. In parallel, the Company is progressing the transition of its assays to additional instrument platforms as part of the lifecycle management of its distribution partnerships. This does not impact our long-term expectations for commercial traction and does not change BioPorto’s full-year 2026 revenue guidance.

Kidney Disease: Improving Global Outcomes (KDIGO) published end March 2026 updated Clinical Practice Guideline Draft for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD). The new guideline recognizes AKI and AKD as part of a continuum, underscoring the importance of knowing earlier, more precise diagnosis using both functional measures and structural biomarker. The Company sees this to support the commercialization of our products in the periods to come.

From an organizational perspective, the focus has been on creating a more streamlined setup. This has included the decision to centralize all R&D activities in Denmark, ensuring a more focused structure and better alignment across the organization under a new scientific leadership.

Subsequent events

As announced on 8 April 2026, BioPorto successfully completed the divestment of its Antibody Business to Janel Life Sciences, LLC. The consideration amounts to USD 10.5 million, with USD 9 million paid at closing and the remaining USD 1.5 million may be received over the coming three years as an earn-out, provided specific commercial milestones are met. The divestment assets comprise research-use-only antibodies and clones, inventory and related contracts. The transaction will result in an accounting gain of approximately DKK 54 million (using a USD/DKK exchange rate of 6.4) on EBITDA and approximately DKK 54 million on net profits but with no impact on adjusted EBITDA. The divestment was effective as of 8 April 2026 and therefore had no impact on the Q1 2026 interim financial results. With the transaction effective April 8^th, the Company secured additional capital, which is expected to bridge the capital needs of the Company until reaching cash flow positive in first half of 2028. The cash position as of April 8, following the initial payment from the divestment, was DKK 98 million.

The Company continues its efforts to strengthen its operational foundation to support future growth, including enhancing key capabilities and further maturing its business processes to enable efficient scaling as access to the adult market is being established. In parallel, the Company is engaging with its suppliers to ensure the necessary capacity expansion and to maintain appropriate inventory levels in line with expected demand. In connection herewith, BioPorto has, for a specific commercialized lot of its NGAL product, identified certain process and product performance variations without impact to patient safety. Therefore, the Company has initiated a voluntary field action to remove and replace the relevant commercial products. The planned actions are not expected to impact the Company’s financial guidance, long-term aspirations and plans, and BioPorto continues to build a scalable foundation for future growth.

Webcast

The Company’s management team will host a webcast today at 11:00 AM CET for investors and analysts to present the Q1 2026 results following a Q&A session.

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

Investor Relations Contacts

Klaus Juhl Wulff, BioPorto A/S, investor@bioporto.com, C: +45 25 63 39 90

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

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 diagnosis 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) for pediatric use 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 2026; 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 2025, particularly under the heading “Risk Factors”.

Attachment

• 2026 05 21 - Announcement No. 11 - UK