August 20, 2026
Announcement no. 14
BioPorto announces Interim Results for the Second Quarter and First half of 2026
Copenhagen, Denmark, August 20, 2026, (GLOBE NEWSWIRE) - BioPorto A/S CVR-no. 17500317 (BioPorto or Company) (CPH:BIOPOR), today announced Interim financial results for the second quarter and first half of 2026.
BioPorto delivered continued underlying NGAL growth of 34% at constant exchange rates, excluding the previously announced voluntary recall impact, while advancing the U.S. adult regulatory pathway, completing the antibody business divestment and maintains full-year guidance.
Carsten Buhl, BioPorto's Chief Executive Officer (CEO), comments "During the second quarter we continued to execute on our Forward Strategy and delivered strong underlying NGAL growth. We sharpened our strategic focus through the divestment of the antibody business and enabled an even clearer prioritization of our core NGAL platform. At the same time, we advanced our U.S. regulatory pathway for the adult segment following FDA feedback, supporting an expanded validation study and a stronger foundation for our planned 510(k) submission. These steps reinforce a more focused organization and strengthen our long-term commercial opportunity in the U.S. AKI market."
Financial highlights - Solid NGAL growth adjusted for product recall driven by US
- For Q2 2026, total NGAL revenue decreased to DKK 6.4 million, a 15% decrease compared to Q2 in 2025. Excluding the impact of the voluntary product recall, the underlying NGAL revenue rose by 23%, and by 34% at constant exchange rates, compared to the second quarter of 2025, driven by a 78% increase in US NGAL RUO sales and ProNephro AKI ® sales with total NGAL sales of DKK 9.2 million.
- For Q2 2026, revenue amounted to DKK 6.9 million (DKK 7.5 million for the same period in 2025). The decrease in revenue was affected by the divestment of the Antibody business and the voluntary product recall. Without the impact from the voluntary product recall the revenue in Q2 would have been DKK 9.7 million.
- The adjusted EBITDA loss in Q2 2026 amounted to DKK 16.3 million, which is a decrease of 11% compared to the adj. EBITDA loss in Q2 2025 of DKK 18.4 million, and in line with expectations. Without the impact from the voluntary product recall, the adjusted EBITDA loss would have been DKK 13.3 million.
- As of June 30, 2026, the Company's cash position was DKK 75.6 million compared to DKK 54.9 million as of December 31, 2025.
- Guidance for 2026 remains unchanged as announced June 9, 2026. The Company continues to 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.
| (DKK million) | Q2 | H1 | Full Year Guidance | ||||||||
| Q2 2026 (excl. voluntary recall impact) | Change (Pct) | Q2 2026 | Q2 2025 | Change (Pct) | H1 2026 (excl. voluntary recall impact) | Change (Pct) | H1 2026 | H1 2025 | Change (Pct) | ||
| Total Revenue | 9.7 | 9% | 6.9 | 10.6 | -35% | 19.1 | 5% | 16.3 | 18.3 | -11% | 38-48 |
| Total NGAL Revenue | 9.2 | 23% | 6.4 | 7.5 | -15% | 15.2 | 25% | 12.4 | 12.1 | 2% | 33-42 |
| Adj. EBITDA loss | 13.3 | -28% | 16.3 | 18.4 | -11% | 31.2 | -33% | 34.2 | 46.5 | -26% | 58-68 |
Key strategic achievements for Q2 2026
- Following feedback from the FDA on the pre-submission, the Company has announced to activate the ProNephro AKI® U.S. Adult Urine NGAL Validation Study in the US with an increased study size to approximately 900 patients. As a result of the increased study size the FDA clearance is expected mid-2028.
- Six new Hospitals for Research Use Only on-boarded in the US, bringing the total to 54 by end of Q2 2026, and on plan to achieve at least 60 US Hospitals by end of 2026, supported by a positive pipeline buildup.
- Voluntary recall of a specific production lot communicated in May 2026. The products from this specific production lot were mainly sold in H2 2025. During the quarter, the Company has received new orders from distributors, while the Company has credited DKK 2.8 million of revenue and has had product costs of additional DKK 0.2 million for replacement products.
- KDIGO (Kidney Disease: Improving Global Outcomes) published end March 2026 updated Clinical Practice Guideline Draft for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD). The Company has provided feedback on the Guideline Draft and expects the final Guideline to be published at the end of 2026.
- Successfully divesting the Antibody business and transferring the activities to Janel Life Sciences, resulting in a transaction net gain of DKK 53.8 million and a strengthened focus and financial position. Following the divestment of the antibody business, the Company updated its financial guidance for 2026. This guidance is reaffirmed and remains unchanged as of today.
Independence of Board of Directors members
The Board has assessed the independence of the members and has concluded that with exception of Donna Haire all members are to be considered independent. Donna Haire is assessed non-independent due to a material business relationship with the Company. Donna Haire is affiliated with The Eriah Group, which has provided consulting services to the Company during the year. The Board considers this relationship in its independence assessment and concludes that it constitutes a material relationship that may affect the director's independence.
Webcast
The Company's management team will host a webcast today at 2:00 PM CET for investors and analysts to present the Q2 2026 results followed by 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 ® (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".
