Core Viewpoint - BioPorto A/S reported continued growth in NGAL sales and outlined strategic milestones in its "Forward" strategy aimed at transforming kidney care globally [1][5]. Financial Performance - Revenue for Q3 2025 reached DKK 10.4 million, a 7% increase year-over-year, and a 10% increase at constant exchange rates [9]. - Total revenue for the first nine months of 2025 was DKK 28.7 million, reflecting a 1% increase compared to the same period last year, with a 2% increase at constant exchange rates [9][10]. - NGAL sales in Q3 2025 totaled DKK 7.2 million, growing by 5% globally and 10% at constant exchange rates [9]. - For the first nine months of 2025, NGAL sales rose by 5% compared to the same period in 2024, and by 7% at constant exchange rates [10]. Strategic Developments - The company successfully delivered its first ProNephro AKI (NGAL) order to the US market in August 2025, marking a significant step in its commercial launch [8]. - Patient enrollment for the clinical cut-off study was completed by the end of October 2025, with a focus on thorough data analysis to ensure high-quality validation study design [4][8]. - The FDA submission has been postponed to the first half of 2027 to align with the updated study design based on FDA feedback [4][8]. Capital and Funding - On November 13, 2025, BioPorto completed a share issuance, raising approximately DKK 43 million, which is expected to support operations through 2026 [6][8]. - The company aims to achieve positive cash flow in the second half of 2027 [6]. Future Guidance - The full-year guidance for 2025 remains unchanged, with total revenue expected to be in the range of DKK 40-45 million and an Adjusted EBITDA loss projected between DKK 75-80 million [11][16].

Core Viewpoint - BioPorto A/S has pre-announced its key financial results for Q3 2025, showing continued growth in NGAL sales, while also revising its full-year guidance for 2025 downward due to performance in the first nine months of the year [1][6]. Financial Performance - Total revenue for the first nine months of 2025 reached DKK 28.7 million, a 1% increase year-over-year, with a 2% increase at constant exchange rates [3]. - NGAL sales increased by 5% compared to the same period in 2024, and by 7% at constant exchange rates, primarily driven by US NGAL RUO sales and ProNephro AKI sales [3]. - US NGAL RUO sales surged by 21% year-over-year, and by 23% at constant exchange rates [3]. - Revenue for Q3 2025 totaled DKK 10.4 million, reflecting a 7% increase compared to Q3 2024, and a 10% increase at constant exchange rates [9]. - Adjusted EBITDA loss for the first nine months of 2025 was DKK 63.3 million, compared to DKK 51.1 million in the same period last year [4]. Sales Breakdown - Q3 2025 NGAL sales in the US amounted to DKK 4.7 million, a 20% increase from Q3 2024, while ROW NGAL sales plummeted by 87% to DKK 0.4 million [5]. - ProNephro AKI sales through distributors in Q3 2025 were DKK 2.1 million [9]. - Total NGAL sales for the first nine months of 2025 were DKK 19.3 million, a 5% increase from the previous year [5]. Guidance Adjustment - The full-year revenue guidance for 2025 has been revised to a range of DKK 40-45 million, down from the previous estimate of DKK 45-50 million [10]. - The adjusted EBITDA loss expectation remains unchanged, projected to be in the range of DKK 75-80 million [10].

Core Insights - BioPorto A/S has provided an update on its ongoing adult clinical study in the US, focusing on the investigational in vitro diagnostic (IVD) urine NGAL assay aimed at identifying patients at risk of acute kidney injury [1][4]. Clinical Study Progress - As of the end of October 2025, BioPorto has successfully completed patient enrollment for its clinical cut-off study, although data collection is taking longer than expected [2]. - The company plans to submit a pre-submission meeting request to the US FDA after analyzing the dataset, which is now anticipated to be completed in Q1 2026 [2]. Regulatory Timeline - The clinical validation study will commence following FDA feedback, leading to a postponement of the FDA regulatory submission from late 2026 to the first half of 2027 [3]. - Despite the delay, the company aims for regulatory clearance in 2027, with plans to initiate commercialization targeting the adult population in the US thereafter [3]. Company Commitment - Carsten Buhl, CEO of BioPorto, emphasized the company's commitment to ensuring high-quality and effective study design, which is intended to mitigate risks associated with the validation study [4]. Product Focus - BioPorto's clinical program is centered on the NGAL biomarker, which is designed to assist in the risk assessment and management of acute kidney injury (AKI), a condition that can lead to severe health consequences if not identified early [7]. - The company markets NGAL tests under various registrations, including CE mark in several countries and FDA clearance for ProNephro AKI in the US [7].

Core Insights - BioPorto A/S has announced the commercial availability of ProNephro AKI (NGAL), an early detection test for Acute Kidney Injury (AKI), in US laboratories through a collaboration with Roche Diagnostics [1][2] - ProNephro AKI (NGAL) is the first AKI biomarker test cleared for pediatric use in the US, aimed at identifying patients at risk of moderate-to-severe AKI within 48-72 hours in the ICU [2][8] - The company plans to expand its market presence through education and awareness programs targeting clinicians and researchers [3] Company Developments - The collaboration with Roche Diagnostics marks a significant step in advancing the adoption of ProNephro AKI across US hospitals [1] - BioPorto's go-to-market strategy is supported by strong research and publications around NGAL, generating high customer interest among clinicians [3] - The company is focused on expanding the ProNephro AKI product line to additional lab chemistry instrumentation and aims to obtain FDA clearance for adult use [6] Industry Context - Acute Kidney Injury is a critical condition that can lead to severe health complications if not detected and treated early, affecting patients in intensive care units [5][8] - The introduction of ProNephro AKI (NGAL) allows for earlier detection of kidney damage compared to traditional serum creatinine tests, enabling timely medical interventions [2][8] - The market for kidney diagnostics is expected to grow as awareness of AKI increases and the demand for early detection tools rises [3][7]

Core Viewpoint - BioPorto A/S reported continued progress in executing its strategic objectives, highlighted by strong sales growth in NGAL products and the initiation of its commercial journey in the US market with the first order of ProNephro AKI [1][3][4]. Financial Performance - Total revenue for the second quarter of 2025 reached DKK 10.6 million, a 15% increase compared to DKK 9.2 million in the same period last year [7]. - For the first half of 2025, total revenue was DKK 18.3 million, reflecting a 2% decrease from DKK 18.7 million in the first half of 2024, primarily due to lower antibody sales [5][9]. - NGAL sales increased by 39% in Q2 2025 compared to Q2 2024, with a 23% rise in the US and a 71% increase in the rest of the world [6][7]. - Adjusted EBITDA loss for Q2 2025 was DKK 18.4 million, compared to DKK 16.2 million in Q2 2024, driven by higher costs associated with clinical studies [7][9]. - The adjusted EBITDA loss for the first half of 2025 was DKK 46.5 million, up from DKK 31.5 million in the same period last year [5][9]. Strategic Developments - A significant milestone was achieved with the receipt of the first purchase order for ProNephro AKI (NGAL) for the US market, marking the start of its commercial launch [6]. - The company is progressing towards FDA submission for ProNephro AKI by the end of 2026, with patient enrollment in clinical studies on track [4][6]. - The board was restructured, with Jens Due Olsen appointed as Chairman and Carsten Buhl as the new CEO effective September 1, 2025, to lead the next growth phase [6]. Guidance - The company has narrowed its full-year revenue guidance for 2025 to DKK 45-50 million, down from the previous range of DKK 45-60 million [8][14]. - Adjusted EBITDA loss guidance for 2025 is now expected to be between DKK 75-80 million, previously estimated at DKK 75-85 million [14].

Core Points - BioPorto A/S has initiated the commercialization of ProNephro AKI (NGAL) for diagnostic use in the US, marking a significant milestone in the company's kidney diagnostics platform [1][3] - The first purchase order for ProNephro AKI (NGAL) has been received from Roche Diagnostics, which will facilitate distribution to US hospitals [2][3] - ProNephro AKI (NGAL) has received FDA 510(k) marketing clearance for use with Roche's cobas® c501 analyzers, which are widely available in medical laboratories and hospitals [2] Company Overview - BioPorto is an in vitro diagnostics company focused on developing actionable biomarkers to improve patient management and outcomes [4] - The company's flagship products utilize the NGAL biomarker to aid in the risk assessment and diagnosis of Acute Kidney Injury (AKI), a condition that can lead to severe health consequences if not identified early [5] - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [6]