BIOPORTO A/S
Health·BIOPOR · Nasdaq Copenhagen·Fiscal year to 31/12/2025
Diagnostic products, including NGAL tests for assessing kidney injury.
Exposure profile
Derived from what the company itself writes. Empty directions mean the report doesn't mention themes of that type.
In their own words
Grouped by theme, from the management review in the annual report. A · The company itself is a verbatim quote, B · From the report is without a verified quote.
Healthcare and hospitals
End markets
DriverPositive impact: strengthens
“KDIGO (Kidney Disease: Improving Global Outcomes) is the leading global organization developing and implementing evidence-based clinical practice guidelines in kidney disease. The next open comment period is expected spring 2025 and BioPorto plans to pursue including ProNephro AKI (NGAL), which is the first AKI biomarker test cleared for pediatric and young adult use in the US, in KDIGO’s highly regarded and important guidelines for AKI.”
Annual report 2025A · The company itself
Market
“We achieved 11% sales growth, mainly driven by continued growth in our research use only NGAL business in the United States.”
Annual report 2025A · The company itself
Market
“Jens Due Olsen & Carsten Buhl Chairman of the Board & Chief Executive Officer A key strategic milestone, was the commercial launch of ProNephro AKI® on the Roche Cobas® c 501 module for the US pediatric market during Q3 2025. This launch aligns with our ambition to establish a commercial platform for kidney diagnostics and drive broad adoption of ProNephro AKI, the NGAL biomarker focused on AKI within the intensive care settings at hospitals globally.”
Annual report 2025A · The company itself
Market
“The primary target accounts and customers for BioPorto’s commercial activities are nephrologists, cardiologists, intensivists and laboratory directors at large hospitals and medical centers The commercial go-to-market strategy for the pediatric launch of ProNephro AKI® (NGAL) has three focus areas: 1.”
Annual report 2025A · The company itself
Chains in: Ageing population strengthens, GLP-1 and obesity treatment mixed effect
Drug approvals
Regulation
DriverNegative impact: weakens
“The Company is currently conducting a clinical trial to obtain regulatory clearance for adult use of NGAL in the US. Timing of future clinical trials depends on many factors outside of the Company’s control, including regulatory pathways and their conditions associated with submissions presently under review that will serve as predicates to other submissions.”
Annual report 2025A · The company itself
DriverNegative impact: weakens
“Further, there is no guarantee that the submission will be approved by the FDA and result in a regulatory clearance.”
Annual report 2025A · The company itself
StrategyPositive impact: strengthens
“Following the first FDA clearance, the Company can conduct validation work and file to expand the marketing authorization to include additional instruments for the US market. These subsequent submissions will follow FDA guidance offered through pre-submission meetings.”
Annual report 2025A · The company itself
Chains out: this strengthens Biotech and drug development
Medical devices
Technology
StrategyPositive impact: strengthens
“In November 2025, we refined our strategy with an increased focus on execution over the next three years. Our focus is on driving market adoption of the NGAL biomarker based primarily on research use only in the US, capturing high growth in North America and the EU, and expanding our addressable market.”
Annual report 2025A · The company itself
StrategyPositive impact: strengthens
“The “Forward” strategic plan focuses on building market adoption, capturing high growth and expanding the addressable market during the next three years with distinct milestones every year.”
Annual report 2025A · The company itself
StrategyPositive impact: strengthens
“An important element in BioPorto’s commercialization plan is to secure strategic distribution partnerships with clinical chemistry instrument manufacturers to drive instrument expansion that are FDA cleared for ProNephro AKI® (NGAL) use to enable more laboratories to implement the test and hence increase the serviceable market. In August 2025, the delivery of the first ProNephro AKI (NGAL) order to the US market, marked the first step in the commercial launch via a strategic distribution partnership.”
Annual report 2025A · The company itself
Market
“We achieved 11% sales growth, mainly driven by continued growth in our research use only NGAL business in the United States.”
Annual report 2025A · The company itself
Market
“Jens Due Olsen & Carsten Buhl Chairman of the Board & Chief Executive Officer A key strategic milestone, was the commercial launch of ProNephro AKI® on the Roche Cobas® c 501 module for the US pediatric market during Q3 2025. This launch aligns with our ambition to establish a commercial platform for kidney diagnostics and drive broad adoption of ProNephro AKI, the NGAL biomarker focused on AKI within the intensive care settings at hospitals globally.”
Annual report 2025A · The company itself
Market
“For 2026, the main growth driver is expected to be NGAL in the U.S. for Research Use Only (RUO). Further, while commercialization of The NGAL TestTM and ProNephro AKI (NGAL) will be the primary contributor for growth, BioPorto expects stable revenue from its antibodies business.”
Annual report 2025A · The company itself
Chains in: Ageing population strengthens
Biotech and drug development
Technology
Market
“BioPorto sells NGAL ELISA kits (Enzyme-Linked Immunosorbent Assay) for research use in humans and in five animal species, from mouse to monkey. BioPorto also provides in-house scaled-up production of antibodies in bulk volumes to meet specific customer needs, i.e., for diagnostic kit manufacturers.”
Annual report 2025A · The company itself
Market
“These research tools are commonly used to study kidney damage associated to nephrotoxicity kidney damage and to assess the effectiveness of new pharmaceutical compounds during development. BioPorto antibodies are frequently used to develop diagnostic immunoassays within several disease areas, including immunodeficiency, allergy, coagulation, diabetes, kidney, and cardiovascular disease.”
Annual report 2025A · The company itself
Chains in: US drug pricing policy mixed effect, Patent expiry and generic competition weakens, Drug approvals strengthens
Chains out: this strengthens Buying contract manufacturing and research (CMO/CRO/EMS), strengthens Contract manufacturers as a business (EMS, CMO, CRO)
Automation and robotics
Technology
StrategyPositive impact: strengthens
“The Company plans to strengthen its core competencies and expand business development resources to set up the organization for future growth.”
Annual report 2025A · The company itself
United States
Geography
DriverPositive impact: strengthens
“The fulfillment of these aspirations is strongly dependent on: • • • Increased market adoption, especially in the US in the short term, which is reliant on the inclusion of kidney damage biomarkers in Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, anticipated in the first part of 2026.”
Annual report 2025A · The company itself
DriverPositive impact: strengthens
“KDIGO (Kidney Disease: Improving Global Outcomes) is the leading global organization developing and implementing evidence-based clinical practice guidelines in kidney disease. The next open comment period is expected spring 2025 and BioPorto plans to pursue including ProNephro AKI (NGAL), which is the first AKI biomarker test cleared for pediatric and young adult use in the US, in KDIGO’s highly regarded and important guidelines for AKI.”
Annual report 2025A · The company itself
Geography
“This is primarily driven by an increase in active hospitals in U.S., where we are pursuing +60 active hospitals.”
Annual report 2025A · The company itself
Geography
“Our focus is on driving market adoption of the NGAL biomarker based primarily on research use only in the US, capturing high growth in North America and the EU, and expanding our addressable market.”
Annual report 2025A · The company itself
Geography
“US NGAL revenue totaled DKK 18.4 million, which is an increase of 25% over the prior year period primarily driven by NGAL (RUO) and revenue from strategic distributors.”
Annual report 2025A · The company itself
Chains in: USD vs DKK/EUR mixed effect
Equity and capital markets
Macro
DriverNegative impact: weakens
“To achieve its strategic objectives, the Company will require additional capital to fund its operations, which may not be available to the Company on acceptable terms. Currently, operations are financed through 2026.”
Annual report 2025A · The company itself
DriverMixed impact: mixed
“The Company’s assessment as to the adequacy of liquidity relies inter alia on assumptions and significant judgements (in addition to those matters discussed cf. Note 2) applied in the Company's budgets and forecasts as well as customary sensitivities, existing capital resources and assumptions concerning the timing, costs and resources required to undertake the Company’s strategic priorities and tactical decisions, including the timing of marketing ProNephro AKI® (NGAL) in the US, commercialization activities for NGAL tests under CE-mark and Antibodies in Europe, supply chain management, and ongoing R&D, all of which under current circumstances remain difficult to predict.”
Annual report 2025A · The company itself
ESG and sustainability reporting
Regulation
DriverMixed impact: mixed
“In Europe, new EU regulations related to in vitro diagnostics devices (IVDR) partly entered into force in May 2022. The new regulation will replace the current CE-mark under IVDD for in vitro diagnostic devices. The IVDR transition deadline was extended by the European Parliament and the Council of the European Union and now runs to December 2028 for certain IVDs.”
Annual report 2025A · The company itself
DriverNegative impact: weakens
“Manufacturers, importers, and authorized representatives must adhere to these stricter rules to to maintain access to promote in the EU market. BioPorto will take the necessary steps to apply in due time and expects that the experience gained and analytical study data created through the FDA submission and subsequent clearance of ProNephro AKI® (NGAL) for pediatric use will facilitate the process.”
Annual report 2025A · The company itself
Consumer spending
Macro
DriverNegative impact: weakens
“The Company’s products and future products may fail to achieve the degree of market acceptance by physicians, laboratory management, healthcare payors and others in the medical community necessary for commercial success and market penetration may be lengthy and difficult.”
Annual report 2025A · The company itself
Chains in: Inflation weakens
Chains out: this strengthens Retail, strengthens Hospitality and leisure, strengthens Premium consumers, strengthens Grocery retail and private label
Subcontractors and haulage capacity
Raw materials and inputs
InputNegative impact: weakens
“The Company’s products are complex to manufacture, and the Company is, in some instances, reliant on sole source suppliers. The Company may encounter difficulties in manufacturing that could have a material adverse effect on the Company’s revenues, cash flow, results of operations and future growth prospects.”
Annual report 2025A · The company itself
Europe
Geography
DriverPositive impact: strengthens
“The NGAL Test is currently available for In Vitro Diagnostic (IVD) use in Europe and other geographies under its CE-mark for all patient populations, disease states, and instruments. Commercially, IVDR approvals may help to drive demand as the lower requirements for clinical evidence of the former IVDD regulation may have caused physicians and laboratories to wait for better data for approval of specific tests and indications before considering clinical use.”
Annual report 2025A · The company itself
Geography
“Our focus is on driving market adoption of the NGAL biomarker based primarily on research use only in the US, capturing high growth in North America and the EU, and expanding our addressable market.”
Annual report 2025A · The company itself
Geography
“The goal for 2027 is to achieve high growth, as the Company will apply US market learnings to its European go-to-market strategy. Growth efforts will focus on a few targeted European markets, utilizing clinical education and business development resources.”
Annual report 2025A · The company itself
Geography
“In Vitro Diagnostic Regulation (IVDR) important to gain further market access BioPorto currently generates revenue from The NGAL TestTM for research use only (RUO), for general use in the European Economic Area (EEA) under the CE-mark, and subject to local registration in Canada, Israel, and South Korea. also strengthening the local geographic distribution sales channels.”
Annual report 2025A · The company itself
Geography
“ROW NGAL revenue totaled DKK 5.5 million, which is a decrease of 35% of which DKK 2.4 million in 2024 was sales through distributors.”
Annual report 2025A · The company itself
EU climate and energy policy
Regulation
DriverPositive impact: strengthens
“The NGAL Test is currently available for In Vitro Diagnostic (IVD) use in Europe and other geographies under its CE-mark for all patient populations, disease states, and instruments. Commercially, IVDR approvals may help to drive demand as the lower requirements for clinical evidence of the former IVDD regulation may have caused physicians and laboratories to wait for better data for approval of specific tests and indications before considering clinical use.”
Annual report 2025A · The company itself
DriverMixed impact: mixed
“Preparation for the EU IVDR certification is underway to meet anticipated demand and facilitate market growth. IVDR certification is expected in 2027.”
Annual report 2025A · The company itself
Chains out: this strengthens Circular economy and recycling, strengthens Energy efficiency
Asia and emerging markets
Geography
Geography
“ROW NGAL revenue totaled DKK 5.5 million, which is a decrease of 35% of which DKK 2.4 million in 2024 was sales through distributors.”
Annual report 2025A · The company itself
Business cycle and GDP growth
Macro
DriverMixed impact: mixed
“The Company’s assessment as to the adequacy of liquidity relies inter alia on assumptions and significant judgements (in addition to those matters discussed cf. Note 2) applied in the Company's budgets and forecasts as well as customary sensitivities, existing capital resources and assumptions concerning the timing, costs and resources required to undertake the Company’s strategic priorities and tactical decisions, including the timing of marketing ProNephro AKI® (NGAL) in the US, commercialization activities for NGAL tests under CE-mark and Antibodies in Europe, supply chain management, and ongoing R&D, all of which under current circumstances remain difficult to predict.”
Annual report 2025A · The company itself
Chains out: this strengthens Global trade volumes, strengthens Construction
Other currencies
Macro
DriverMixed impact: mixed
“Revenue for 2025 was DKK 40.3 million (DKK 36.2 million), an increase of 11%, and at constant exchange rates a growth of 13%.”
Annual report 2025A · The company itself
Competitors mentioned in the report
No named competitors in the report.
Financial figures
| Revenue latest fiscal year | 0.04 bn DKK |
| Revenue growth vs. the year before, same method | 11.2 % |
| EBITDA reported by the company | -0.08 bn DKK |
| Net debt debt incl. leasing minus cash | N/A |
| Diluted EPS per share | N/A |
Source: annual report (ESEF) A. See the report
Criteria
| Profit | N/A |
| Growing | ✓ |
| Healthy balance sheet | N/A |
Only the criteria that can be computed from financial statements on this page. The remaining criteria (such as price and dividend) need a share price and are in the analysis.