Qiagen N : 2025 Annual Report 2025 IFRS Annual Report
QGEN
Published on 04/30/2026 at 01:09 pm EDT
QIAGEN N.V.
IFRS Annual Report 2025
QIAGEN N.V. | IFRS Annual Report 2025 Management Report Financial Statements Sustainability Statement Other Information Appendices Page 2
Table of Contents
3 Management Report
121
Consolidated Financial Statements
359
Other Information
4 Business and Operating Environment
QIAGEN N.V. and Subsidiaries
360
Independent Auditor's Report
4 Strategy, Business Model and Value Chain 122 Consolidated Balance Sheets
10 Operating Environment 124 Consolidated Income Statements
372
Limited Assurance Report of the Independent Auditor
23 Risks and Risk Management 125 Consolidated Statements of Comprehensive
376
Appropriation of Net Income
Income
126 Consolidated Statements of Cash Flows
42 Financial and Share Performance
377
Appendices
128 Consolidated Statements of Changes in
42 Operating and Financial Review
51 QIAGEN Shares 129 Notes to the Consolidated Financial
378
390
Memorandum and Articles of Association Taxation
Equity
55 Corporate Governance
Statements
396
409
Government Regulatio
Exchange Controls
56 Message from the Chair
239
Company Financial Statements of
410
Documents on Display
ns
59 Governance Structure
61 Managing Board
63 Supervisory Board
70 Supervisory Board Report
81 Board-Related Matters
83 Shareholder Meetings and Share Capital
89 Additional Information
94 Corporate Governance Statement
95 Remuneration Report
120 Responsibility Statement of the Managing Board
240 Company Balance Sheets
242 Company Income Statements
243 Company Statements of Changes in Equity
245 Notes to the Company Financial Statements
263 Sustainability Statement
264 General Information
280 Environment
308 Social
341 Governance
350 Sustainability Statement - Annex
411 Controls and Procedures
412 EU Taxonomy
419 Signatures
The sections Business and Operating Environment, Financial and Share performance, Corporate Governance, Responsibility Statement of the Managing Board, and Sustainability Statement, together form the Management Report within the meaning of article 2:391 of the Dutch Civil Code.
Management Report
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Management Report
4 Business and Operating Environment
4 Strategy, Business Model and Value Chain
10 Operating Environment
23 Risks and Risk Management
42 Financial and Share Performance
42 Operating and Financial Review
51 QIAGEN Shares
55 Corporate Governance
56 Message from the Chair
59 Governance Structure
61 Managing Board
63 Supervisory Board
81 Board-Related Matters
83 Shareholder Meetings and Share Capital
89 Additional Information
94 Corporate Governance Statement
70 Supervisory Board Report
95 Remuneration Report
120 Responsibility Statement of the Managing Board
Management Report
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Business and Operating Environment
QIAGEN is a leading global provider of Sample to Insight solutions, enabling customers to extract and gain valuable molecular insights from samples containing the building blocks of life. Our Sample technologies isolate and process DNA (deoxyribonucleic acid), RNA (ribonucleic acid) and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis while bioinformatics software and knowledge bases can be used to interpret data to find actionable insights. Automation solutions bring these processes together into seamless and cost-effective workflows. We serve over 500,000 customers globally in Life Sciences (academia, pharma research and development, industrial applications, primarily forensics) and molecular diagnostics for clinical healthcare. As of December 31, 2025, we employed approximately 5,700 people in over 35 locations worldwide.
QIAGEN was founded in 1984 and began operations in 1986 as a pioneer in the emerging biotechnology sector with a revolutionary method that standardized and accelerated the extraction and purification of nucleic acids from biological samples, which means any material containing DNA, RNA or proteins. As molecular biology and genomic knowledge has grown to influence many areas of daily life, we have expanded to serve the full spectrum of market needs while developing new instruments, consumables and digital solutions, partnering with researchers and pharmaceutical companies, and acquiring companies and technologies that best complement our portfolio. We continue to accelerate our portfolio growth and increase our efficiency and effectiveness while also enhancing our customer experience, our corporate citizenship and our position as an employer of choice.
Our growth has been funded through internally generated funds as well as through debt offerings in recent years.
Our Global Shares are listed on the New York Stock Exchange under the ticker symbol QGEN and on the Frankfurt Stock Exchange as QIA.
QIAGEN N.V. is the holding company for more than 60 consolidated subsidiaries, many of which have the primary function of distributing our products and services on a regional basis. Certain subsidiaries also have
research and development or production activities. The Company is registered under its commercial and legal name QIAGEN N.V. with the trade register (kamer van koophandel) of the Dutch region Limburg Noord under file number 12036979. QIAGEN N.V. is incorporated under Dutch law as a public limited liability company (naamloze vennootschap) and is organized as a holding company. Our principal executive office is located at Hulsterweg 82, 5912 PL Venlo, The Netherlands, and our telephone number is +31-77-355-6600.
Further information on QIAGEN can be found at https://www.qiagen.com. The
U.S. Securities and Exchange Commission (SEC) website at https://www.sec.gov contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. Information contained in, or that can be accessed through, our website is not a part of, and shall not be incorporated by reference into, this Annual Report. We have included our website address in this document solely as an inactive textual reference. We file our IFRS annual report (in accordance with EU-IFRS and Dutch law) with the AFM, including the register that the AFM maintains.
QIAGEN provides sample and assay technologies that enable customers to extract, detect and interpret molecular information from biological samples. From decoding DNA to accelerating life-saving breakthroughs, our vision is simple: to make improvements in life possible. We create value by offering integrated workflows that combine consumables with instruments, automation and bioinformatics. This approach allows customers to standardize research and molecular testing and generate actionable insights across applications faster, better and more efficiently.
Our strategy is anchored by a commitment to deliver solid profitable growth by focusing our resources on a group of pillars that represented $1.5 billion in sales, approximately 72% of sales, in 2025 and that are expected to reach combined annual sales of approximately $2 billion by 2028. We are aligning our investments within these pillars to maximize sales in proven high-growth markets.
Management Report
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The pillars involve three product groups where QIAGEN is developing leadership positions: the digital PCR (Polymerase Chain Reaction) platform QIAcuity, the clinical PCR syndromic testing solution QIAstat-Dx and the QIAGEN Digital Insights portfolio of bioinformatics solutions for improved analysis and interpretation of complex genomic data. Additionally, two pillars involve product groups where QIAGEN has strong top positions and where we want to consolidate our leadership: Sample technologies that are used to gain access to DNA and RNA from a biological sample and the QuantiFERON technology platform for latent disease detection, best known for its use in detecting latent tuberculosis (TB).
We classify our products into two main categories: consumables and related revenues; and instruments and related services. Global Presence by Product Category and Geographic Market and QIAGEN Product Groups provide additional details
We manufacture our products at facilities in the United States, Europe and China. In China, products are primarily made for the local market. For more information about our manufacturing sites, please refer to the Description of Property section.
Our commercial teams are organized into specialized groups across three major regions: Americas; Europe, Middle East and Africa (EMEA); and Asia Pacific and Japan (including China). In certain markets, we also work with third-party distributors to extend our reach. For more information, please refer to the Sales and Marketing section. Details about our employees can be found in the Employees section.
QIAGEN operates a centralized distribution network with regional hubs responsible for local logistics.
Building a sustainable business
Our products support scientific progress and healthcare by enabling molecular insights that can contribute to improved decision-making and patient outcomes worldwide. We are committed to sustainable business practices integrating stakeholder perspectives-including those of customers, employees, regulators and public authorities, suppliers and shareholders-into relevant aspects of our operations.
Our sustainability policy outlines key principles and responsibilities for QIAGEN employees regarding environmental, social and governance (ESG) matters, reflecting our commitment to a more sustainable future. Oversight of sustainability is provided by the Supervisory Board, through its Nomination & Governance Committee. The Managing Board is responsible for integrating sustainability into strategy, and works with the Executive Committee on operational execution.
Our targets and actions address priorities such as reducing the use of plastic and advancing environment-friendly product solutions; lowering emissions across our operations and supply chain; and working with suppliers to promote environmental and social responsibility. Through these initiatives, we aim to embed sustainability considerations across our business activities and product life cycle.
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Global presence
Venlo, Global HQ
Hilden, EMEA HQ
Germantown, Americas HQ
Delivering products to
>160 countries
Shanghai, China HQ
Singapore, Asia HQ
Direct sales in
>40 countries
Global presence
Value is created across QIAGEN's value chain through innovation in sample and assay technologies, high-quality manufacturing and regulatory-compliant supply. As part of its business model, QIAGEN integrates post-market surveillance into the life-cycle management of its products. The ongoing monitoring of product performance supports the early identification of
quality-related risks, underpins regulatory compliance across markets, and helps maintain trust in QIAGEN's solutions among customers, patients and end users. These efforts are supported by commercial execution and global distribution capabilities. Our research and development are carried out within manufacturing entities and specialized R&D centers. Manufacturing sites source raw materials and semi-finished products from affiliated entities and independent third parties to support the production of QIAGEN consumables, instruments and related solutions. Sales to end customers are managed through local sales subsidiaries and, in certain markets, third-party distributors. A centralized distribution network connects manufacturing entities with local sales organizations, supported by two global distribution hubs that consolidate demand and optimize supply logistics.
Our products serve more than 500,000 customers across the continuum from Life Sciences (academia, pharmaceutical R&D and applied testing) to molecular diagnostics (clinical healthcare). QIAGEN operates globally, with significant markets in the Americas, Europe, Middle East, Africa (EMEA), Asia Pacific and Japan (including China).
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Upstream
Our
Downstream
operations Sales to >500,000 customers
Raw materials
R&D services and in-licensing Finished goods
Logistical and warehousing services Semi-finished goods
IT and other services
~5,700 QIAGENers across all EC functions Manufacturing in EMEA, Americas and APAC regions
Research and Development
Consumables Instruments Bioinformatics
(digital insights)
Consumables Instrumentation services Instruments
Licensing (e.g., patents) Bioinformatics
Material topics
Climate change • Climate change • Consumers and end-users • Climate change
Resource use and circular economy (e.g. resource inflows)
Business conduct
Resource use and circular economy (e.g., closing the loop, waste management)
Own workforce
Working conditions
Diversity and inclusion
Resource use and circular economy (e.g. products, services, waste)
Business conduct
Workers in the value chain • Business conduct
Occupational health and safety
Workers in the value chain
Consumers and end-users
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Understanding and addressing the interests and expectations of our stakeholders is essential for our business strategy and long-term value creation. In 2025, we actively engaged with stakeholders through various channels, incorporating their insights into our materiality assessment, business processes and capital allocation dialogue. These engagements supported decisions on product portfolio priorities, operational improvements, transparency in external reporting and the way we communicate our approach to profitable growth, investment discipline and long-term shareholder value creation.
In particular, engagement with shareholders and the financial community provided feedback not only on sustainability performance and governance, but also on strategy execution, capital deployment priorities and the balance between investing for future growth and maintaining financial discipline. This dialogue helps us explain how we allocate resources to strategic growth pillars, innovation, operational capabilities and other value-enhancing initiatives, while maintaining a focus on returns, resilience and transparency. In accordance with the Dutch Corporate Governance Code, our Stakeholder Engagement Policy is available on our website.
Stakeholders How we engage Why we engage How we respond
Shareholders and the financial community
Quarterly reports and earnings calls, including strategy and capital allocation updates
Annual report and annual general meeting communications, including long-term value creation priorities
Regular roadshows and investor calls on growth, portfolio priorities and returns
Investor relations website and related shareholder communications
Investor feedback
Long-term shareholder value creation
Capital deployment to investment priorities with highest returns
Financial resilience
Understanding investor expectations toward sustainability
Business conduct: attracting responsible investors
Clearer communication on long-term shareholder value creation
Communication and execution of capital allocation priorities, including strategic acquisitions, digital capabilities and growth pillar investments
Communication of shareholder return actions, including the annual cash dividend and synthetic share repurchase programs
Stronger linkage between strategy, resource allocation and profitable growth
Increased transparency on sustainability performance
ESG information embedded in internal and external communications
Expanded CDP environmental reporting
Employees • Strategic meetings: annual kick-offs and quarterly
feedback checks
Reviews: one-on-one sessions and 180° feedback
Engagement: surveys, pulse checks, events and webinars
Trainings: management and regulatory sessions, ESG awareness
Foster performance culture
Ensure highest health and safety
Equal treatment and opportunities for all
Employee development, training and skills
Annual employee survey results show QIAGEN as having a high-performance culture
Recognition of QIAGEN as top employer in several regions
Local site action plans to enhance workplace culture
Increased safety awareness
Reduction in unstaffed positions
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Stakeholders How we engage Why we engage How we respond
Customers • Surveys: customer satisfaction measurement
Digital tools: web chat and 24/7 service portal
Events: conferences, trade fairs, roadshows and infotainment shows; best practice sharing at our facilities
Engagement: bilateral meetings, production tours, training, customer audits
Sustainability: questionnaires and dedicated webpage
Suppliers • Workshops on target costing design
Risk assessment, strategic reviews, supplier days
Best practice workshops, bilateral engagement, joint initiatives, webinars with employees
Strong ongoing customer engagement and retention
Ensure timely access to products and services
Support sustainable lab practices and efficient waste management
Supply chain security and risk reduction
Business conduct: responsible sourcing standards
Sustainability commitments
Incorporation of customer requirements into product and service offering
Expansion of product portfolio with increasing focus on sustainable products and plastics reduction
Service improvements, e.g., web chat functionalities and Net Promoter Score (NPS) above internal benchmarks
Lab waste treatment pilot
Cost stability in challenging macroeconomic environment
Mapped strategic supplier base to reduce supply risk and assess sustainability factors
Pilot projects on low-carbon solutions
General society and local communities
Banks and financial institutions
Collaboration with public health laboratories, research and academic institutions around the world
Mandatory reporting and information (e.g., annual report, non-financial reporting)
Bilateral meetings
Access to products and services: enhancement of access to healthcare
Efficient financing costs
Improvements in ESG ratings
Laboratory infrastructure and capacity building to support pandemic preparedness
Response initiatives, local surveillance
Development of new tools for pathogen detection
Reduced financing costs for debt offerings
Favorable ESG performance-linked loan conditions
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Operating Environment
In 2025, global economic growth remained moderate, with the International Monetary Fund (IMF) estimating real GDP growth of about 3%. Inflation eased in many economies, supporting the start of monetary policy easing in some markets, although underlying price pressures persisted in parts of the advanced economies. Growth remained uneven, with advanced economies expanding by around 1.5% and emerging market and developing economies growing at just above 4%.
Economic activity continued to be influenced by elevated public and private debt levels, trade policy uncertainty and geopolitical tensions, contributing to a cautious operating environment across many sectors.
The Life Sciences and molecular diagnostics industries showed mixed conditions in 2025. While demand growth continued in several application areas-including oncology, infectious disease testing and biopharmaceutical research
-customer purchasing patterns remained uneven across regions. Companies increasingly emphasized expanding the use of installed instrument platforms and menu breadth to drive growth in clinical and research settings.
QIAGEN remained positioned to address these trends through its global footprint and commercial scale, supported by key platforms such as QIAstat-Dx, for which cumulative placements exceeded 5,200 instruments worldwide at year-end 2025.
The addressable Life Sciences and molecular diagnostics segments are estimated at about $12 billion in annual sales, with expectations for continued single-digit growth.
Our leadership in molecular research and testing solutions leverages our product portfolio across a wide range of applications. These are grouped into two main categories:
Consumables and related revenues, which include consumables kits, bioinformatics solutions, royalties, co-development milestone payments and services (90% of total net sales in 2025)
Instruments and related services and contracts (10% of total net sales in 2025)
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Selected biological samples
Applications
Blood
Serum Plasma Urine
Other body
fluids Bone Plants
Soil
Tubes / plates
cfDNA
amplification
Arrays
Gene editing Epigenetics
Cellular analytics
/ NGS
Liquid biopsy Microbiome Gene silencing Proteomics
Sample technologies represent one of our pillars and include products involved in the first step of any molecular lab process.
Input demands
Processing
Target analytes
Tissue
Low / high-volume
Manual
Genomic DNA
Cells
Saliva
Low-quantity
Plasmid DNA
DNA
Sequencing
Input demands
Low-quantity
Automated
mRNA, rRNA
High-quantity
Low- to high-
miRNA
Tubes / plates
throughput systems
Circulating tumor cells and proteins
Our broad portfolio of Sample technologies includes consumables and instruments used in sample collection, stabilization, storage, purification and quality control. Some of our consumables are designed to run on our instruments, while others are universal kits designed for use with any molecular-testing platform. These products are used in research and applied testing (forensics/human identification and food safety) in laboratories as well as clinical testing.
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Sample technologies Selected QIAGEN brands
Primary Sample technology consumables
Nucleic acid stabilization and purification kits designed for primary sample materials (DNA, RNA), manual and automated processing for genotyping, gene expression, viral and bacterial analysis
Mainly based on silica membrane and magnetic bead technologies Secondary Sample technology consumables
QIAamp
PAXgene
AllPrep
DNeasy
QIAprep&
RNeasy
MagAttract
QIAwave
Kits and components for purification of nucleic acids from secondary sample materials (e.g., gel, plasmid DNA) • QIAprep
QIAGEN Plasmid
HiSpeed
QIAquick
QIAfilter
EndoFree
DyeEx
Sample technology instruments
Instruments for nucleic acid purification, quality control and accessories • QIAsymphony
EZ2 Connect
TissueLyser III
QIAcube Connect
EZ2 Connect MDx
QIAcube HT
QIAxcel Connect
QIAcube Connect MDx
QIAsprint Connect
Diagnostic solutions
Diagnostic solutions include our molecular testing platforms and consumables, covering two of our pillars with QuantiFERON and QIAstat-Dx. They also include Precision Diagnostics, which comprises companion diagnostic co-development revenues from projects with pharmaceutical companies, regulated assays and solutions for laboratory-developed tests. Additional areas include oncology and sexual and reproductive health for detection of various diseases and for other laboratory processes.
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Diagnostic solutions Selected QIAGEN brands
Immune response consumables
Interferon-Gamma Release Assay (IGRA) for latent TB testing
Assays for post-transplant testing, viral load monitoring
QuantiFERON
Oncology and sexual and reproductive health consumables
Assays for analysis of genomic variants such as mutations, insertions, deletions and fusions
Assays for prenatal testing and detection of sexually transmitted diseases and HPV
therascreen
AmniSure / PartoSure
ipsogen
digene HC2
Sample to Insight instruments and dedicated assays
One-step molecular analysis of hard-to-diagnose syndromes
Fully integrated PCR testing
QIAstat-Dx
QIAstat-Dx Rise
PCR/Nucleic acid amplification
PCR/Nucleic acid amplification involves our research and applied PCR
solutions and components. The product group includes another of our pillars,
QIAcuity. We offer optimized solutions for end-point PCR, quantitative PCR and
digital PCR. Our kits, assays, instruments and accessories amplify and detect
targets and streamline workflow for virtually any application.
PCR/Nucleic acid amplification Selected QIAGEN brands
Research PCR consumables
Different generations of PCR, quantitative and digital PCR, reverse transcription and combinations (RT-PCR) kits for analysis of gene expression, genotyping and gene regulation, running on QIAGEN or third-party instruments and technologies
Human ID/Forensics assay consumables
QuantiTect
OneStep RT-PCR
OmniScript
QIAcuity
QIAGEN Multiplex
miRCURY
AllTaq
GeneGlobe
QuantiNova
HotStarTaq
UltraRun Long Range
Short tandem repeat (STR) assays for human ID, additional assays for food contamination • Investigator (human
ID / forensics)
PCR instruments
Digital PCR solutions
qPCR solutions OEM consumables
QIAcuity
Rotor-Gene Q
QIAgility • QIAcuityDx
Custom-developed and configured enzymes and PCR solutions that are sold to OEM customers • Provided on an individualized contract basis
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Genomics/NGS
This product group includes our universal next-generation sequencing (NGS) solutions for use with any NGS sequencer as well as the full bioinformatics portfolio offered by QIAGEN Digital Insights, which also represents one of our pillars.
Genomics/NGS Selected QIAGEN brands
Universal NGS consumables
Predefined and custom NGS gene panels (DNA, RNA), library prep kits and components, whole genome amplification, DNA methylation analysis, etc.
Sequence-based assays for forensic genetic genealogy QIAGEN Digital Insights solutions
Bioinformatics solutions analyze and interpret data to deliver actionable insights from NGS. This includes freestanding software or cloud-based solutions and is integrated into many QIAGEN consumables and instruments.
QIAseq
GeneGlobe
QCI Secondary Analysis
QCI Interpret
QCI Precision
REPLI-g
EpiTect
CLC Workbenches
OmicSoft Lands
Ingenuity Pathway Analysis
ForenSeq Kintelligence
Biomedical Knowledge Base
HGMD
HSMD
PGXI
Other
Revenues from various sources, including protein biology products, royalties, intellectual property and freight charges.
We sell our products to more than 500,000 customers in two broad customer groups: molecular diagnostics (clinical testing) and Life Sciences (academia, pharmaceutical research and development and applied testing).
At the end of 2025, our current total addressable market was estimated at approximately $12 billion annually, with estimates indicating that this market opportunity would grow about 4-6% annually through 2028.
Molecular diagnostics
The molecular diagnostics market includes healthcare providers engaged in many aspects of patient care that require accurate diagnoses and insights to guide treatment decisions in oncology, infectious diseases and immune monitoring.
We offer one of the broadest portfolios of molecular technologies for healthcare. The success of molecular testing in healthcare depends on the ability to accurately analyze purified nucleic acid samples from sources such as blood, tissue, body fluids and stool. Automated systems process tests reliably and efficiently, often handling hundreds of samples simultaneously. Our range of assays for diseases and biomarkers speeds up and simplifies laboratory workflow and standardizes lab procedures.
Molecular testing is the most dynamic segment of the global in vitro diagnostics market. The pandemic has demonstrated the value of molecular testing in healthcare, and we expect the market to provide significant growth opportunities.
We have built a position as a preferred partner to co-develop companion diagnostics paired with targeted drugs and have created a rich pipeline of molecular tests that are transforming the treatment of cancer and other diseases. We have more than 30 master collaboration agreements with pharmaceutical industry customers, some with multiple co-development projects. Companion
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diagnostics move through clinical trials and regulatory approvals, along with the paired drugs, to commercialization and marketing to healthcare providers.
Sample technologies Assay technologies Instruments Bioinformatics
For extraction from:
Tissue
Blood
Swabs, other
Indication areas
Oncology
Immune modulation
Infectious diseases Technologies: QuantiFERON, Polymerase Chain Reaction (PCR), Next-generation sequencing (NGS)
QIAstat-Dx
QIAsymphony RGQ
QIAcube Connect MDx
EZ2 Connect MDx
QIAstat Rise
QIAGEN Clinical Insight (QCI)
Hereditary diseases
Somatic and germline cancers
Other diseases
Life Sciences
The Life Sciences market includes governments and biotechnology companies, where researchers and scientists are using molecular testing technologies to advance scientific knowledge in the pursuit of new breakthroughs that can lead to new medicines and diagnostics for use in clinical healthcare. This market also includes the use of molecular testing technologies for applied applications, in particular for forensics as well as food and veterinary testing. These customers are all often served by public funding and research and development budgets within pharmaceutical companies.
We partner with customers across diverse disciplines in academia and industry, providing sample technologies, assay technologies, bioinformatics and services to universities and institutes, pharmaceutical and biotech companies, governments and law enforcement agencies.
We provide Sample to Insight solutions to academic and research institutions around the world. We focus on enabling researchers to use high-quality technologies to generate reliable, fast, highly reproducible results, sometimes replacing time-consuming traditional or in-house methods. We often partner with leading institutions on research projects and develop customized solutions such as NGS panels for the sequencing of multiple gene targets.
We are a global leader in solutions for governments and industry, particularly in forensic testing and human identification. The value of genetic "fingerprinting" has been proven in criminal investigations and examinations of paternity or ancestry, as well as in food safety. We provide sample collection and analytical solutions for law enforcement and human identification labs as well as advanced technologies for studies of microbiomes and their effect on health and the environment.
We have deep relationships with pharmaceutical and biotechnology companies. Drug discovery and development as well as translational research efforts increasingly employ genomic information, both to guide research in diseases and to differentiate patient populations that are most likely to respond to particular therapies. We estimate that about half of our sales to these companies supports research, while the other half supports clinical development, including stratification of patient populations based on genetic information. Also, QIAGEN Digital Insights solutions are widely used to guide pharmaceutical research and treatment options.
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Sample technologies Assay technologies Instruments Bioinformatics
~300 different kit types for extraction and purification of DNA, RNA and proteins from tissue, blood, cells, stool, plants, soil and other sample types
Real-time PCR
Digital PCR
Next-generation sequencing
QIAsymphony
QIAcube Connect
QIAcuity digital PCR
Ingenuity Pathway Analysis (IPA)
Genomics Workbench/Server
Microbial Pro Suite/RNA-seq
Microbial Epigenetics
The markets for most of our products are very competitive. Competitors may have developed, or could develop in the future, new technologies that compete with our products or even render our products obsolete. In sample technology products, we experience competition in various markets from other companies providing sample preparation products in kit form and assay solutions. These competitors include, but are not limited to, companies with a focus on nucleic acid separation and purification kits, assay solutions, reagents and instrumentation. We compete with other suppliers through innovative technologies and products, offering a comprehensive solution for nucleic acid collection, pre-treatment, separation and purification needs as well as downstream applications. Our products provide significant advantages in terms of speed, reliability, accuracy, convenience, reproducibility and ease of use.
Some of our other products within our molecular diagnostics customer class, such as tests for chlamydia, gonorrhea, hepatitis B virus, herpes simplex virus and CMV (cytomegalovirus), compete against existing screening, monitoring and diagnostic technologies, including tissue culture and antigen-based diagnostic methodologies. We believe the primary competitive factors in the market for gene-based probe diagnostics and other screening devices are clinical validation, performance and reliability, ease of use, time to result, standardization, cost, proprietary position, competitors' market shares, access to distribution channels, regulatory approvals and reimbursement.
We believe our competitors typically do not have the same comprehensive approach to sample-to-insight solutions as we do, nor do they have the ability to provide the broad range of technologies and depth of products and services that we offer.
Current and potential competitors may be in the process of seeking Federal Drug Administration (FDA) or foreign regulatory approvals for their respective products. Our continued future success will depend in large part on our ability to maintain our technological advantage over competing products, expand our market presence and preserve customer loyalty. There can be no assurance that we will be able to compete effectively in the future or that development by others will not render our technologies or products noncompetitive.
Net sales for the product categories are based on those revenues related to sample and assay products and related revenues, including bioinformatics solutions, as well as revenues derived from instrumentation sales.
Net sales (in millions) 2025 2024
Consumables and related revenues
$1,876.4
$1,760.2
Instrumentation
213.6
218.0
Total
$2,090.0
$1,978.2
Geographical information
We sell our products in more than 160 countries. The following table shows total revenue by geographic market for the past three years (with net sales attributed to countries based on the location of the customer, as certain subsidiaries have international distribution):
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Net sales (in millions) 2025 2024
United States
$998.4
$942.0
Other Americas
88.1
89.6
Total Americas
1,086.5
1,031.6
Europe, Middle East and Africa
712.8
648.5
Asia Pacific, Japan and Rest of World
290.7
298.2
Total
$2,090.0
$1,978.2
Our business is not significantly impacted by seasonal factors. Historically, a portion of our sales has been to researchers, universities, government laboratories and private foundations whose funding is dependent upon grants from government agencies, such as the National Institutes of Health and similar bodies. To the extent that our customers experience increases, decreases or delays in funding arrangements and budget approvals, and to the extent that customers' activities are slowed, such as during times of higher unemployment, vacation periods or delays in approvals of government budgets or government shutdowns, we may experience fluctuations in sales volumes during the year or delays from one period to the next in the recognition of sales. Additionally, we have customers who are active in the diagnostics testing market, and sales to these customers fluctuate to the extent that their activities are impacted by public health concerns. For example, the timing and severity of viral infections such as influenza or the SARS-CoV-2 virus may impact demand for our products.
We are committed to expanding our global leadership in "Sample to Insight" solutions serving customers in the Life Sciences and clinical diagnostics. We target our research and development resources at the most promising technologies to address the unmet needs of our customers in healthcare and research labs in key geographic markets.
Innovation at QIAGEN follows parallel paths:
Creating new systems for automation of workflows - platforms for laboratories, hospitals and other users of novel molecular technologies
Expanding our broad portfolio of content - including assays to detect and measure biomarkers for disease or genetic identification
Integrating QIAGEN Digital Insights with the testing process - software and cloud-based resources to interpret and transform raw molecular data into useful insights
Innovation in automation systems positions us in the fast-growing fields of molecular testing and generates ongoing demand for our consumable products. We are developing and commercializing a robust pipeline of assays for preventive screening and diagnostic profiling of diseases, detection of biomarkers to guide Precision Diagnostics in cancer and other diseases and other molecular targets. Our assay development program aims to commercialize tests that will add value to our QIAsymphony and QIAstat-Dx automation systems in the coming years together with developing next-generation sequencing (NGS) kits to support our universal NGS franchise and our in vitro diagnostics partnership with Illumina. We continue to develop applications for the QIAcuity digital PCR system, which is designed to make digital PCR technology available to Life Sciences and clinical laboratories worldwide, as well as to other participants in the NGS market.
We market our products primarily through subsidiaries in markets with the greatest sales potential in the Americas, Europe, Australia and Asia.
Experienced marketing and sales staff, many of them scientists with academic degrees in molecular biology or related areas, sell our products and support our customers. Business managers oversee key accounts to ensure that we serve customers' commercial needs, such as procurement processes, financing, data on costs and the value of our systems, while maintaining collaborative relationships. In many markets, we have specialized independent distributors and importers.
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Our go-to marketing strategy focuses on providing differentiated, high-quality products across the value chain from Sample to Insight, integrating components into end-to-end solutions when possible and enhancing relationships with a commitment to technical excellence and customer service. Our omni-channel approach seeks to engage customers through their preferred channels -- online, by phone or in person - and to optimize investment in different customer types.
We continue to drive the growth of our digital marketing channels - including our website at https://www.qiagen.com, product-specific sites and social media. The recent pandemic saw an increase in virtual events and use of digital sales channels. We have likewise increased the activities in digital marketing to adapt to these market changes, such as installing an in-house studio to facilitate creation of video content and live virtual events.
Our eCommerce team works with clients to provide automated processes supporting a variety of electronic transactions and all major eProcurement systems.
My QIAGEN is an easy-to-use self-service portal that is personalized to our customers' needs and enables them to manage different activities in one central place. Customers can now easily reorder products, place bulk orders, apply quotes to their cart and track their order status. Functionality in the dashboard allows customers to monitor their instrument use and view the status of licenses and service agreements. Additionally, customers can access our exclusive content and services, such as webinars, handbooks and other documents.
Our GeneGlobe Design and Analysis Hub (https://www.geneglobe.com) is a valuable outreach to scientists in pharma and academia, enabling researchers to search and order from approximately 25 million pre-designed and custom PCR assay kits, NGS assay panels and other products. The hub brings next-level experiment planning, execution and follow-up to Life Science researchers, linking our QIAGEN Digital Insights solutions with ordering of assays to accelerate research.
We use a range of tools to provide customers with direct access to technical support, inform them of new product offerings and enhance our reputation for technical excellence, high-quality products and commitment to service. For
example, our technical service support allows existing or potential customers to discuss or ask questions about our products and molecular biology procedures with QIAGEN scientists online or by phone. Frequent communication with customers enables us to identify market needs, learn of new developments and opportunities, and respond with new products.
We also distribute publications, including our catalog, to current and potential customers worldwide, providing new product information, updates and articles about existing and new applications. In addition, we hold numerous scientific seminars at clinical, academic and industrial research institutes worldwide and at major scientific and clinical meetings. We conduct direct-marketing campaigns to announce new products and special promotions, and we offer electronic newsletters and webinars highlighting molecular biology applications.
For laboratories that frequently rely on our consumables, the QIAstock program maintains inventory on-site to keep up with their requirements. QIAGEN representatives make regular visits to replenish the stock and help with other needs, and we are automating this process with digital technologies. Easy-to-use digital ordering, inventory monitoring and customer-driven changes make QIAstock an efficient system for providing ready access to our products for the hundreds of customers worldwide who use this program.
We have made, and expect to continue making, investments in intellectual property. In 2025, additions to our intangible assets outside of business combinations totaled $140.8 million, and as of December 31, 2025, patent and license rights, totaled a net $38.6 million. While we do not depend solely on any individual patent or technology, we are significantly dependent in the aggregate on technology that we own or license. Therefore, we consider protection of proprietary technologies and products one of the major keys to our business success. We rely on a combination of patents, licenses and trademarks to establish and protect proprietary rights. As of December 31, 2025, we owned 280 issued patents in the United States, 214 issued patents in Germany and 1,569 issued patents in other major industrialized countries. We had 353 pending patent applications. Our policy is to file patent
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applications in Western Europe, the United States and Japan. Patents in most countries have a term of 20 years from the date of filing the patent application. We intend to aggressively prosecute and enforce patents and to otherwise protect our proprietary technologies. We also rely on trade secrets, know-how, continuing technological innovation and licensing opportunities to develop and maintain our competitive position.
Our practice is to require employees, consultants, outside scientific collaborators, sponsored researchers and other advisers to execute confidentiality agreements at the start of their relationships with us. These agreements provide that all confidential information developed by or made known to the individual during the course of the relationship is to be kept confidential and not disclosed to third parties, subject to a right to publish certain information in scientific literature under specific circumstances and other exceptions. In the case of our employees, the agreements provide that all inventions conceived by individuals in the course of their employment will be our exclusive property, subject to local laws.
See Risk Factors included in Risks and Risk Management for details regarding risks related to our reliance on patents and proprietary rights.
We strive to ensure that our quality standards, compliance with laws and regulations as well as environmental and social standards are maintained along the entire value chain of suppliers and partners. We demand the same from our business partners. Suppliers are subjected to a risk analysis with regard to environmental and social criteria based on their geographic location. Our supplier policy, which all new suppliers sign, is available on our website and contains requirements with regard to legal compliance, bribery and corruption, labor rights, nondiscrimination and fair treatment, health and safety as well as environmental protection and conservation. In addition, first-tier suppliers must confirm REACH, RoHS and conflict minerals compliance, as appropriate. As part of our supplier assessment procedures, on a monthly basis, we evaluate the supply performance of our raw material and component suppliers. We assess, on a continuous basis, potential alternative sources of
such materials and components and, on a yearly basis, the risks and benefits of reliance on our existing suppliers.
We strive to maintain inventories at a sufficient level to ensure reasonable customer service levels and to guard against normal volatility in availability. We buy materials for our products from many suppliers and are not dependent on any one supplier or group of suppliers for our business as a whole. Raw materials generally include chemicals, raw separation media, biologics, plastics, electronics and packaging. Certain raw materials are produced under our specifications. We have inventory agreements with the majority of our suppliers, and we closely monitor stock levels to maintain adequate supplies.
In 2025, markets experienced increased pressure because of ongoing geopolitical tensions. QIAGEN's strong material positions and thorough coverage ensure that customer product availability remains unaffected at present. However, uncertainty remains about how markets may develop in 2026 in light of ongoing geopolitical tensions.
U.S. legislation mandates transparency in sourcing conflict minerals-tantalum, tin, tungsten and gold-from mines in the Democratic Republic of Congo (DRC) and its adjoining countries. Some of our instrumentation components, purchased from third-party suppliers, contain gold. As required, we investigate our supply chain and disclose any use of conflict minerals from these regions. Annually, we conduct due diligence to determine the presence and origin of conflict minerals in our products. Since we do not purchase directly from smelters or refineries, we rely on supplier declarations. We filed our latest conflict minerals disclosure with the SEC on Form SD for the year ended December 31, 2024, on May 30, 2025, and will update our disclosures as required.
Our primary production and manufacturing facilities for consumable products are in Germany, the United States, Spain and China. Our software development facilities are in the United States, Germany, Poland, Denmark and
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Romania, and our Center of Excellence for the development of companion diagnostics for personalized healthcare is in the United Kingdom.
Our production and manufacturing operations are highly integrated and supported by sophisticated inventory control and production-planning processes. Production management personnel are highly qualified, and many have advanced degrees in engineering, business and science. In recent years, we have made capital investments principally in automated and interchangeable production equipment to expand production capacity and improve operating efficiency. We have also invested in enterprise systems to support production planning and operational control, including continued deployment and enhancement of SAP-based systems. SAP R/3 is used to integrate the majority of our operating subsidiaries, and we are in the process of a multi-year implementation of S/4HANA.
In addition, capital expenditures include selected investments intended to support energy efficiency and emissions reduction initiatives, including renewable energy projects. Capital expenditures for property, plant and equipment totaled $76.8 million in 2025 and $68.0 million in 2024. These capital expenditures were financed from operating cash flows, and we expect operating cash flows to remain the primary source of funding for future capital expenditures.
We have an established quality system, including standard manufacturing and documentation procedures, intended to ensure that products are produced and tested in accordance with the FDA's Quality System Regulations, which impose current Good Manufacturing Practice (cGMP) requirements. For facilities that accommodate cGMP production, special areas were built, and these facilities operate in accordance with cGMP requirements.
The consumable products manufactured at QIAGEN GmbH in Germany and QIAGEN Sciences LLC in Maryland are produced under ISO 9001: 2015, ISO 13485:2016, MDSAP. By the end of 2025, we aim to complete the implementation of ISO 50001, a voluntary international standard that aids organizations in managing their energy usage. Our certifications form part of our ongoing commitment to provide our customers with high-quality, state-of-the-art sample and assay technologies under our Total Quality Management system.
Our corporate headquarters are located in Venlo, Netherlands. The below table summarizes our largest facilities. Other subsidiaries throughout the world lease smaller amounts of space.
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Facility location
Country
Purpose
Owned or leased
Square feet
Hilden
Germany
Manufacturing, warehousing, distribution, research and development and administration
Owned
986,000
Germantown, Maryland
U.S.
Manufacturing, warehousing, distribution and administration
Owned
285,000
Shenzhen
China
Development, manufacturing, warehousing, distribution and administration
Leased
107,200
Manchester
U.K.
Development and Service Solutions
Leased
96,300
Frederick, Maryland
U.S.
Development, Service Solutions, manufacturing, warehousing and distribution
Leased
76,500
Wrocław
Poland
Business service center
Leased
65,100
Beverly, Massachusetts
U.S.
Enzyme manufacturing
Leased
44,000
Barcelona
Spain
Development, manufacturing, warehousing, distribution and administration
Leased
31,900
Manila
Philippines
Business service center
Leased
29,300
Shanghai
China
Service Solutions and administration
Leased
28,400
Gdańsk
Poland
Enzyme manufacturing, development, warehousing and administration
Leased
23,300
Germantown, Maryland
U.S.
Service Solutions and training center
Leased
13,500
Redwood City, California
U.S.
Bioinformatics
Leased
12,700
Gdynia
Poland
Enzyme manufacturing, development and warehousing
Leased
11,200
Our facilities in Hilden, Germany, and Germantown, Maryland, have the capacity to expand in the future by an additional 300,000 square feet each. Our facility in Ann Arbor, Michigan, was closed in 2025, following the decision to discontinue the NeuMoDx portfolio as discussed in Note 6 "Restructuring."
We believe our existing production and distribution facilities can support anticipated production needs for the next 36 months. Our production and manufacturing operations are subject to various federal, state and local laws and regulations, including environmental regulations. We do not believe we have any material issues relating to these laws and regulations.
As a company headquartered in the European Union (EU), we recognize freedom of association and collective bargaining as fundamental to maintaining a positive relationship between management and employee representatives. A significant portion of our workforce is employed in
Organization for Security and Co-operation in Europe (OSCE) member states, and we comply with all applicable labor laws in every region where we operate. Management values its relationships with regional labor unions and employees, and considers them to be positive.
We are committed to respecting and promoting human rights, as outlined in our Human Rights Policy, available on our website at https://www.qiagen.com. This policy is communicated globally via our Company intranet and provided to all new employees. We foster an open-door workplace culture where employees can freely raise concerns with management or Human Resources without fear of retaliation. Our policy explicitly ensures that employees may discuss working conditions openly without risk of reprisal, intimidation or harassment.
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The following tables provide information on the number of employees by geographical region and main category of activity as of December 31, 2025 and 2024:
Employees by region 2025 2024
Americas
1,210
1,252
Europe, Middle East & Africa
3,318
3,352
Asia Pacific, Japan and Rest of World
1,126
1,161
Total
5,654
5,765
Employees by function 2025 2024
Production
27 %
28 %
Research & Development
17 %
18 %
Sales
38 %
37 %
Marketing
6 %
6 %
Administration
12 %
11 %
Total
100 %
100 %
Depending on local laws and customs, there are different types of employment ranging from long-term fixed contracts to temporary positions, along with flexible time and programs for employees returning to work after parental leave. In 2025, temporary employees with a fixed-term work contract represented 5.7%.
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Risks and Risk Management
Role Responsibility
Our Approach
Our risk management approach is built on four key principles:
Active involvement of the Supervisory Board and senior management
Comprehensive policies and procedures
Audit Committee of the Supervisory Board
The Audit Committee of the Supervisory Board oversees the effectiveness of the Company's risk management and internal control systems, regularly reviews and discusses key risks, the overall risk profile, and emerging threats, and evaluates the adequacy of internal controls related to financial reporting, compliance, and operational risks to ensure robust governance and organizational resilience.
Robust risk monitoring, management and information systems
Effective internal controls
Governance and oversight
QIAGEN is managed by a Managing Board and an independent Supervisory
Managing Board The Managing Board provides strategic oversight and governance to ensure that risk management is fully embedded into QIAGEN's long-term objectives and organizational structures, regularly reviewing principal risks, internal controls, and regulatory compliance while overseeing the effectiveness of the risk management system (RMS); it also ensures accurate and transparent external risk disclosures and supports senior management in sustaining a
strong, organization-wide risk culture.
Board, both appointed at the Annual General Meeting of Shareholders. The
Managing Board oversees our risk management system, developing and implementing strategies, controls and mitigation measures to identify and manage current and emerging risks. These risk management policies are embedded in our corporate governance framework, code of ethics and financial reporting controls. Dedicated functional experts continuously evaluate and address business risks.
Executive Committee
Enterprise Risk Management (ERM)
The Executive Committee approves and aligns the ERM and RMS frameworks with QIAGEN's strategic objectives, promotes a strong risk-aware culture, conducts quarterly reviews of key risks and opportunities, ensures effective governance and resources for risk management, and continuously monitors and improves the organization's risk culture.
The Enterprise Risk Management function develops, implements, and continually enhances the ERM framework and processes while coordinating risk management activities across the organization; guides and supports Risk Owners in identifying, assessing, and reporting risks; prepares and delivers risk reports to the Executive Committee and external stakeholders; monitors key risks and opportunities through workshops and assessments; and serves as the primary contact for external audits and regulatory reporting.
Risk Owners Risk Owners identify, assess, and report risks and opportunities within their responsibility, decide and implement appropriate risk response strategies, continuously monitor risk progression and the effectiveness of mitigation measures, escalate risks to the ERM team when they cannot be adequately mitigated, and maintain the risk register by updating entries and providing incident or ad-hoc reports as necessary.
Employees Employees are expected to understand and manage the risks relevant to their roles, follow all established risk management policies and procedures, and actively contribute to a risk-aware culture through their everyday actions and decision-making.
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QIAGEN Enterprise Risk Management framework
The risk management framework at QIAGEN is built on the internationally recognized standard ISO 31000, integrating risk management into every aspect of the organization's purpose, governance, strategy and operations. The ERM policy establishes a structured approach for identifying, assessing, and responding to key risks and opportunities that could impact the ability of QIAGEN to achieve its objectives. This framework defines clear roles and responsibilities-spanning the Managing Board, Executive Committee, ERM function, Risk Owners, and the Audit Committee of the Supervisory Board-and sets out principles for risk appetite, tolerance thresholds, and risk profile monitoring. The ERM cycle is continuous and iterative, aligning risk management activities with strategic planning, financial cycles and operational decision-making. Key risks are reviewed at least quarterly, with ad-hoc assessments triggered by significant internal or external events, ensuring that risk management remains dynamic and responsive to change. The policy governing the risk management system (RMS) further details how risk is managed through the Three Lines Model, which delineates accountability across operational management, risk oversight and internal audit. The RMS provides a comprehensive process for risk identification, analysis, evaluation, response and monitoring, supported by tools such as the Risk Universe and Risk Register. Risks are assessed using top-down and bottom-up approaches, with prioritization based on likelihood, impact and alignment with QIAGEN's risk appetite. The framework emphasizes a robust risk culture, transparency, and collaboration, ensuring that risk management is a shared responsibility and embedded in daily business activities. Regular reviews and continuous improvement of the ERM and RMS frameworks ensure that QIAGEN remains resilient, compliant, and well-positioned to capitalize on opportunities while mitigating threats.
Assessment of effectiveness of internal risk management and control systems (VOR)
The Managing Board assesses the effectiveness of QIAGEN's internal risk management and control systems in relation to operational, compliance and reporting risks on an ongoing basis and at least annually. This assessment is informed by the continuous ERM cycle (including quarterly reviews of key risks
and ad-hoc assessments triggered by significant events), the monitoring performed by Risk Owners and relevant oversight functions and the assurance activities embedded in the Three Lines Model. The outcomes of this monitoring and assurance are reviewed within management governance forums and discussed with the Audit Committee of the Supervisory Board as part of the governance cycle, including the status of remediation actions for identified deficiencies and observations.
Risk classification and assessment
We categorize risks into five main types:
Strategic risk - refers to the potential for losses due to a failed business strategy, planning or decision-making. It is associated with the overall future business plans and strategy of a company, including mergers and acquisitions, management of external network/partnerships or changes in management.
Operational risk - is defined as the risk of loss resulting from inadequate or defective systems and internal processes, from human or technical failure and from damage to physical assets.
Compliance risk - refers to the potential for legal penalties, financial forfeiture, and damage to reputation that a company could face as a result of failing to comply with laws, regulations, industry standards or codes of conduct applicable to its business activities.
Financial risk - refers to the possibility of a company experiencing financial losses due to changes on the financial market or wrong/insufficient financial structure management.
External risk - refers to the potential threats or uncertainties that originate outside of a company's control and can negatively impact its operations, performance, or profitability. These risks arise from the organization's interactions with the natural environment, society and regulatory frameworks, and they can affect the long-term sustainability of the business.
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All risks are assessed based on their likelihood and potential impact on our ability to achieve business objectives. The goal is to identify risks that could materially threaten our success and to implement timely mitigation actions.
Internal controls and compliance
Our corporate governance framework defines the roles of the Managing Board, Supervisory Board and Audit Committee, as detailed under Corporate Governance. We maintain internal controls to ensure the integrity of financial reporting, further described in Controls and Procedures.
Additionally, our Compliance Committee, composed of senior executives from multiple functions, oversees compliance with legal and regulatory requirements and ensures adherence to corporate policies, including our Code of Conduct and Ethics as described in the Corporate Governance section of this annual report.
Risk appetite
Risk appetite is the amount and category of risk that QIAGEN is willing to pursue or retain in the pursuit of its objectives. The risk appetite is documented in a formal statement owned by the Executive Committee, while the Managing Board provides oversight and approval to ensure alignment with the company's strategic direction. This statement serves as a guiding principle for senior management in daily decision-making.
It defines clear parameters for acceptable and unacceptable risks, ensuring consistent and aligned decisions across the organization, and is reviewed and updated annually to remain aligned with strategic priorities.
QIAGEN maintains a balanced risk appetite, seeking to pursue strategic growth opportunities while maintaining robust controls to ensure that risks are managed within defined tolerances and do not compromise our long-term objectives, regulatory compliance or stakeholder trust.
Our business faces significant risks that also threaten the entire industry. Our business, financial condition or results of operations could be materially and adversely affected if any of these risks occurs. In addition, risks and
uncertainties that are currently unknown to QIAGEN or are considered immaterial might affect its business, operations and financial condition. This report also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors including the risks described below and elsewhere in this annual report. The risks described below are grouped into main categories, with the risks within each category listed the significant risks. The risks mentioned reflect our risk assessment but do not imply that the company has no other risks and cannot have a material adverse impact on our results of operations, liquidity, or capital resources.
Summary of risk factors
QIAGEN operates in a complex and evolving global environment that presents a broad range of strategic, operational, financial, compliance and external risks which could, individually or collectively, affect the achievement of its strategic objectives, financial condition or long-term sustainability. We maintain a structured enterprise risk management framework designed to identify, assess, and manage these risks; however, no assurance can be given that all risks can be fully anticipated or mitigated.
Strategic risks arise from the need to continuously align our strategy with rapidly changing market conditions, technological developments and stakeholder expectations. This includes the effective integration of environmental, social and governance considerations into decision-making, the successful development and commercialization of innovative products and the ability to respond to competitive pressures and disruptive technologies. Our broad presence in global markets and the execution and integration of acquisitions may expose us to additional economic, political and regulatory uncertainties, potentially affecting anticipated benefits and growth trajectories.
Operational risks relate to the complexity of the company's global operations and reliance on people, systems, suppliers, and partners. The loss of key personnel, disruptions to manufacturing or supply chains, or insufficient resilience could adversely impact operational performance. Increased reliance on digital platforms, data, and advanced technologies, including artificial
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intelligence, may introduce ethical, security and governance challenges. Cyber security incidents, system outages or failures to adequately protect sensitive information could result in operational disruption, regulatory scrutiny or reputational harm.
Compliance risks stem from operating in a highly regulated environment across multiple jurisdictions. We are subject to evolving legal and regulatory requirements related to product approvals, quality standards, data protection, anti-bribery and anti-corruption laws, intellectual property, environmental regulations and supply-chain due-diligence obligations. Failure to comply with these requirements, or delays in adapting to regulatory changes, could result in fines, litigation, restrictions on market access, or damage to our reputation.
Financial risks include exposure to changes in tax laws and interpretations, global minimum tax regimes, foreign exchange fluctuations and the potential impairment of goodwill and intangible assets. Our capital structure and debt obligations may limit financial flexibility, while future capital requirements may depend on market conditions and access to funding on acceptable terms.
Variability in customer purchasing patterns and reimbursement environments may also affect forecasting accuracy and financial performance.
External risks arise from factors largely beyond the company's control, including global economic uncertainty, inflationary pressures, interest rate movements, geopolitical conflicts, trade restrictions and changes in public funding or reimbursement policies. These factors may influence customer demand, supply-chain stability, cost structures and market access. In addition, evolving stakeholder expectations related to sustainability and corporate responsibility may affect competitiveness, reputation and long-term value creation.
While we actively monitor and manage these risks within our defined risk appetite, the realization of any of these uncertainties could materially and adversely affect our business, financial condition, results of operations or strategic objectives.
Strategic risks
Our presence in potential high-growth markets exposes us to economic, political and regulatory risks.
In markets emerging across the Middle East and Asia, we may face heightened risks compared to regions where we have an established presence. These risks include:
Economic volatility, particularly in markets reliant on a limited range of industries;
Weak legal systems, which may hinder contract enforcement and intellectual property protection;
Government instability, policy changes and privatization efforts that could impact operations;
Foreign exchange controls that may restrict the movement of funds; and
Abrupt changes in customs and tax regulations, affecting product movement and financial performance.
Additionally, conducting business across multiple jurisdictions-such as moving products between countries or providing services from subsidiaries abroad-increases exposure to regulatory shifts and compliance challenges. These factors could negatively impact our operations and financial results.
Emerging competitors and rapid technological advances in diagnostics, combined with regulatory hurdles, threaten the market position, profitability and growth prospects of our diagnostic and syndromic testing products.
The competitive landscape for our diagnostic portfolio, including QuantiFERON, QIAcuity and QIAstat-Dx, is evolving rapidly. Competitors may introduce new technologies, expand strategic partnerships or obtain regulatory approvals earlier than anticipated, which could adversely impact adoption of our products, limit market share expansion or render certain offerings less competitive. For example, announcements by major industry participants regarding advancements in latent tuberculosis testing, as well as new point of care syndromic testing platforms introduced in key markets, illustrate the pace
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at which competitive dynamics can shift. These developments highlight that the absence of clear current regulatory or clinical progress from competitors does not eliminate the risk of future market disruptions.
Additionally, new instruments and assay systems brought to market by competitors may target both established and emerging market segments, potentially outpacing the capabilities of our current technologies. Competitor expansion into the U.S., Europe, Japan and other regions-coupled with evolving trade policies, including U.S. tariffs-may create pricing pressures, influence customer purchasing behavior or challenge our ability to match product breadth and performance.
Regulatory requirements further contribute to this risk. The need to secure timely approvals for new assays or platform enhancements may delay our product launches, limit our ability to respond to market shifts, or hinder execution of our growth strategies. If we do not meet development timelines or effectively navigate regulatory pathways, we may be unable to achieve anticipated revenue targets or capitalize on market opportunities.
If we fail to keep pace with technological innovation, respond to competitive pressures or obtain required regulatory clearances in a timely manner, our market position could weaken, our profitability could be adversely impacted and our ability to achieve planned growth-particularly in high growth diagnostic segments-could be materially and negatively affected.
Challenges in managing growth and acquisition integration may limit expected benefits and adversely impact our performance.
We have grown significantly in recent years, with total net sales increasing from $1.87 billion in 2020 to $2.09 billion in 2025. This growth has been driven by both organic expansion and strategic acquisitions, including the 2025 acquisitions of Parse Biosciences, Inc. and Genoox. We might continue acquiring businesses that align with our Sample to Insight strategy in molecular research and clinical testing. However, successful integration of acquisitions requires significant resources, coordination and expense.
Our ability to manage ongoing growth and execute on expansion initiatives is subject to risks, and the outcomes may not achieve the anticipated benefits or
align with evolving operational, financial or strategic expectations. As we continue to broaden our activities and pursue opportunities to strengthen our portfolio-including through the acquisition of complementary businesses-we may be required to adapt our internal processes, systems and organizational structures to support a larger and more complex operating model. These efforts may place increasing demands on management attention and require significant capital and human resources.
The successful integration of acquired businesses, technologies and personnel remains inherently uncertain. Expansion activities may expose us to challenges related to aligning operations, maintaining consistent standards, integrating systems and processes, and retaining key talent. Acquisitions can also introduce additional regulatory, commercial and financial considerations, including potential liabilities, shifting market dynamics or delays in realizing intended synergies. Performance may also depend on external parties, such as suppliers, partners or acquired teams, whose activities we do not fully control.
As we grow, we may need to expand or enhance our operational and financial control frameworks to ensure continued reliability, consistency and compliance across a broader footprint. In some cases, implementation of new systems or scaling of existing capabilities may temporarily disrupt operations or increase costs. Divergent stakeholder expectations regarding the pace and direction of expansion may also lead to reputational risks if outcomes are perceived as insufficient or misaligned.
Failure to effectively manage growth or integrate acquisitions could result in operational inefficiencies, delays in execution, increased expenses, or challenges in maintaining expected performance levels. In certain circumstances, these developments may also affect our financial condition, reputation or ability to achieve long-term strategic objectives.
We rely on collaborative commercial relationships to develop and/or market some of our products.
We rely on a variety of external partners to develop, commercialize, and distribute certain products. These collaborations-whether with academic institutions, pharmaceutical and biotechnology companies, or regional
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commercial partners-support key parts of our portfolio but also introduce uncertainty. Outcomes depend on the priorities, performance and long-term commitment of these partners, and in some cases on clinical, regulatory or market factors outside our direct control.
Companion diagnostic programs, joint development efforts and
distributor-based marketing arrangements may be affected by shifting partner strategies, misalignment of objectives, limited visibility into local markets, or competing activities. Our ability to expand or maintain market access in certain regions similarly depends on the effectiveness and reliability of external parties.
In general, the success of these collaborative relationships influences development timelines, market penetration and commercial performance, and any disruption or change in partner engagement could affect our business.
Our ability to sustain growth relies on the timely development, introduction and market acceptance of innovative products.
The molecular research and testing markets are characterized by rapid technological advancements and frequent new product introductions. To remain competitive, we must continuously develop products that keep pace with evolving customer needs, regulatory expectations and scientific trends. Delays in product development, regulatory approvals or market adoption-such as delays in clinical evidence generation, changing regulatory requirements or extended development cycles-could result in loss of market share that may be difficult to recover.
Several factors influence market acceptance of new products, including:
availability, quality and pricing relative to competing offerings;
timing of launch versus alternative technologies;
perceived utility, performance data and supporting research;
regulatory approvals, compliance status and evolving standards; and
shifts in industry needs across Life Sciences, applied markets and molecular diagnostics.
We are making significant investments in intellectual property, software and manufacturing capacity to support new automation platforms such as
QIAstat-Dx and QIAcuity. These platforms follow a razor-razorblade model in which the value of the instruments depends heavily on the timely expansion of assay menus, availability of new test panels and the ability to scale production. Delays in menu expansion, challenges in lifecycle management or production capacity constraints may slow platform adoption and reduce expected consumables demand.
Advancements in artificial intelligence-including AI-driven bioinformatics, automated interpretation tools and competitive AI-curated data platforms-may accelerate innovation cycles and shift customer expectations. If we are unable to integrate or adapt to such emerging technologies, or if competitors adopt them more effectively, our competitive position and long-term growth prospects could be adversely affected.
Slower-than-expected customer uptake of new systems may negatively impact instrument and consumables sales, compress margins, and weaken our market position. Higher fixed development and manufacturing costs may exert pressure on gross margins and operating income until sufficient market traction is achieved. In addition, production constraints, yield variability or delays in scaling manufacturing capacity could limit availability of new products and impair commercial performance.
If we fail to keep pace with innovation, address market demands, expand product menus, or successfully scale production, our business, financial condition and growth prospects could be materially impacted.
Insufficient ESG integration combined with environmental and circular-economy compliance shortcomings may adversely affect our operations and reputation. Our efforts relating to environmental, social and governance (ESG) matters are subject to risks, and the outcomes may not achieve the anticipated benefits or align with evolving regulations and stakeholders' expectations.
Sustainability-related standards, disclosure requirements and evaluation criteria continue to shift rapidly across jurisdictions, and we may be required to adjust our practices, reporting processes and internal governance mechanisms in
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response to emerging rules or divergent stakeholder views. As expectations develop, including those connected to environmental performance, resource efficiency and circular-economy principles, we may need to expand our reporting capabilities or adopt new operational approaches, which could require significant management focus and the allocation of additional resources.
Performance against our sustainability metrics may also depend on third parties, such as suppliers or external service providers, whose practices we do not fully control. This reliance increases the risk that inconsistencies in external data, varying levels of maturity across supply chains, or limitations in oversight could affect perceived or actual ESG performance and influence stakeholder confidence. In certain instances, reporting obligations may require disclosures that could negatively affect external perceptions of our activities or expose us to scrutiny.
In addition, our operations-and those of our partners-are subject to an evolving set of environmental, health and safety laws. Failure to comply with these requirements, or delays in adapting to new regulations, could result in fines, penalties, or other enforcement actions. We may also face environmental liabilities inherent to our activities or those of our manufacturing partners, including obligations related to remediation or the handling of regulated materials. As these regulatory frameworks become more stringent, we may be required to incur substantial expenses to meet compliance expectations, which could disrupt operations or affect our financial performance.
Taken together, increasing regulatory complexity, shifting stakeholder expectations and potential environmental compliance obligations may heighten our exposure to operational, financial and reputational risks.
Operational risks
The unplanned departure of critical personnel could disrupt business continuity, delay projects and change recruitment plans.
Our ability to operate effectively depends on the retention of key personnel who possess strategic, operational, technical or regulatory expertise that is essential
to our success. These individuals include senior leadership, functional heads and subject matter experts across the company. The loss of any of these employees could disrupt business sustainability, delay decision-making processes, or impede the execution of core initiatives. If we are unable to retain or adequately replace such personnel, we may experience the loss of intellectual capital, institutional knowledge and strategic relationships that are critical to ongoing projects and regulatory or market commitments.
The departure of key personnel could delay regulatory filings, product development activities or market expansion efforts, and may reduce credibility with customers, partners, or regulators. Reliance on interim leadership, external consultants or accelerated recruitment efforts could increase operating costs and introduce operational inefficiencies. If successors do not possess requisite skills, experience or influence, our ability to execute our strategic priorities could be impaired. Any of these developments could materially and adversely affect our business, financial condition and results of operations.
In November 2025, we announced that Thierry Bernard will step down as Chief Executive Officer and Managing Director once a successor is appointed. Following the announcement of Mr. Bernard's departure and prior to the appointment of a successor, uncertainty regarding future leadership may create distraction, affect employee morale and retention, delay decision-making, and disrupt execution. We may experience adverse effects on our business if we are unable to identify a suitable successor. Even after a successor is appointed, the transition of leadership responsibilities and the successor's integration into our business, operations, and stakeholder relationships may result in disruption, reduced effectiveness, or delays in the execution of our strategic and operational priorities.
Inadequate sustainable operations and resilience planning may expose us to prolonged outages, data loss, and regulatory penalties.
If elements of this framework are not fully aligned, consistently implemented or periodically updated across the organization, resilience efforts may vary between locations or functions. In such circumstances, assessments of critical processes and dependencies may not always reflect evolving operational needs, and recovery priorities may not be optimized for all potential scenarios.
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Testing, review, and validation activities contribute to strengthening preparedness. However, if these activities do not occur with sufficient frequency, scope or coordination-or if evolving business priorities limit participation-certain aspects of our resilience, posture may not be fully evaluated under real-world conditions.
Should gaps in governance, assurance or coverage arise, disruptive events such as supply chain interruptions, facility outages, system incidents or broader crises could challenge our ability to maintain normal operations. We may experience delays in certain activities, temporary interruptions to business processes, or increased operational complexity. These circumstances could affect our ability to meet some external commitments, result in higher operating costs, or lead to reputational impacts with customers, partners or other stakeholders. Given the global nature of our operations and exposure to macroeconomic, geopolitical and operational uncertainties, such developments could adversely affect our business, financial condition, or results of operations.
Increasing customer demands for cost reductions and purchasing efficiencies may restrict our pricing flexibility and affect our business.
Many customers are consolidating suppliers and negotiating bulk purchasing agreements to lower costs, often through large distributors that secure discounted pricing and direct purchasing control. To maintain access to these customers, we may be required to offer lower prices to distributors, reducing our margins.
Additionally, large customers, including the U.S. federal government, may seek special pricing arrangements, such as blanket purchase agreements, further limiting pricing flexibility.
For some customers, we have facilitated sales through distributors and value-added partners at their request. If sales through intermediaries increase, our gross profit and overall financial performance could be adversely impacted.
Expanding supply-chain due-diligence and reporting obligations, combined with potential shortages, cost increases and logistics disruptions, may materially impact our business performance.
Our business relies on a global supply chain that is increasingly affected by evolving regulatory, operational and market-driven risks, and outcomes may not achieve the anticipated benefits or align with emerging expectations.
Expanding due-diligence and transparency requirements-such as the German Supply Chain Act, U.S. conflict-minerals reporting rules, and proposed EU-wide frameworks like the Corporate Sustainability Due Diligence Directive-are reshaping obligations across jurisdictions and may require enhanced supplier oversight, deeper visibility into upstream tiers, and more comprehensive documentation. Meeting these expectations may increase administrative effort, necessitate updates to contractual terms, or require additional investment in reporting capabilities.
At the same time, our operations depend on the availability, quality and continuity of materials, components and logistics services sourced from a diverse supplier base, including certain limited- or single-source providers for key raw materials such as specialized plastics, biological components and chemicals. Vulnerabilities in supplier resilience-particularly among second-and third-tier upstream partners or suppliers operating in high-risk or capacity-constrained regions-may heighten the likelihood of disruptions, requalification needs or accelerated alternative sourcing efforts. Insufficient contractual governance, including agreements that do not fully mandate continuity assurances, regulatory compliance or protection of intellectual property, may further constrain our ability to enforce standards or ensure supply-chain reliability.
Broader macroeconomic and geopolitical factors-including inflationary pressures, trade restrictions, regional instability or global logistics constraints-may contribute to fluctuating costs, extended lead times or reduced supplier reliability. Variability in supplier maturity, documentation practices or compliance readiness may also create challenges in meeting regulatory or customer expectations. Failure by us or our suppliers to comply with emerging supply-chain regulations or due-diligence standards could result in enforcement
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actions, limitations on market access, increased operational costs or reputational impacts.
If we are unable to effectively navigate these regulatory developments or mitigate supplier-related, logistical or resource-driven pressures, our operations, commercial performance and stakeholder relationships could be adversely affected. Collectively, these factors may influence our ability to maintain continuity across the value chain and meet broader strategic objectives.
We rely on up-to-date systems and strong processes to meet evolving cyber laws, strong cyber security governance and standards, if our cyber security governance, data-security practices or critical systems fail to keep pace with evolving requirements, we may face unauthorized access, operational disruptions, fines and reputational harm.
We rely on an interconnected digital environment-including internal systems, cloud platforms, third-party and vendor-hosted services, and AI-enabled tools-to support operations and safeguard sensitive information. As the threat landscape grows in sophistication and ecosystems become more complex, we may face risks related to unauthorized access, loss or alteration of data, disruption of critical services, or inconsistent application of security and privacy practices across environments we manage and those managed by others. The pace of technology change-combined with legacy constraints, supplier dependencies, and limited transparency into how external or AI-driven components are configured, trained, or controlled-may at times exceed the maturity of our governance processes and make it challenging to uniformly monitor or validate performance, data provenance, and protective controls.
In parallel, privacy, cyber security and digital-compliance expectations continue to evolve across jurisdictions and sectors. Meeting these requirements may require additional documentation, testing, model/algorithm validation, and reporting, as well as periodic updates to systems and processes. Delays or gaps in adapting to new or emerging standards, or weaknesses in control design or execution, could increase the likelihood of incidents or
non-compliance. If such events occur-whether due to external attack (including increasingly sophisticated or state-sponsored actors), third-party or
supply-chain issues, inadvertent human actions, or technical failures-we could
experience service interruptions, constraints on data access or transfer, increased remediation and investigative effort, or scrutiny from customers, partners and regulators. In certain circumstances, these developments may result in financial or operational consequences, contractual exposure, enforcement actions or reputational impacts.
While we continue to invest in security capabilities, awareness, and oversight, residual risk remains. Collectively, these factors could adversely affect our operations, compliance posture, financial condition, stakeholder confidence, or ability to meet broader strategic objectives.
We depend on artificial intelligence (AI) systems to support key business activities; therefore, we may be affected by ethical, security, and operational failures that expose us to new risks.
We increasingly rely on AI-enabled systems across our operations, digital platforms and decision-support processes, which may expose us to a range of ethical, regulatory, security and operational risks. As AI technologies continue to evolve rapidly, their capabilities, limitations and long-term implications remain only partially understood. The development, deployment and use of AI may therefore introduce uncertainties that could affect the reliability of our processes, the quality of our outputs, or the effectiveness of business activities that depend on these tools.
Because AI capabilities are embedded to varying degrees within internally developed systems as well as cloud-based or vendor-hosted solutions, we may be exposed to risks arising from limited transparency into how underlying models are trained, the types of data used, or the safeguards implemented by third-party providers. Flawed, biased or incomplete model outputs-or premature reliance on insufficiently validated AI functionality-could influence decision-making, impede product development activities, delay new offerings or otherwise affect operational performance. These challenges may also create reputational or competitive harm if stakeholders perceive our use of AI as unreliable, inappropriate or inconsistent with emerging sector expectations.
AI adoption may amplify existing cyber security and data protection risks. As systems process larger data volumes, integrate cloud services or automate
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complex workflows, vulnerabilities may arise that increase exposure to unauthorized access, misuse of confidential information or inadvertent disclosure of sensitive or personal data. Weaknesses in AI-enhanced tools-whether due to configuration errors, model failures or malicious exploitation-may result in operational disruption, financial loss, regulatory scrutiny or legal liability.
The regulatory landscape for AI is still developing, and new or forthcoming requirements may impose additional obligations related to data provenance, transparency, accountability, intellectual property, accuracy, safety or human oversight. Compliance with rapidly evolving standards may require additional documentation, validation, testing or governance controls, and could increase operational complexity or limit how we deploy certain AI-based capabilities. Failure to meet these expectations may lead to legal penalties, heightened supervisory attention or reputational harm.
In addition, divergent stakeholder views on responsible AI use may increase scrutiny of how AI-supported processes are designed, monitored and governed. Demonstrating appropriate oversight, ensuring explainability of outputs, or addressing bias-related concerns may be challenging, particularly where AI components are embedded deep within broader systems. The novelty of AI technologies may also expose us to risks that are not yet foreseeable, including those related to competitive dynamics, intellectual property protection, ethical considerations or unanticipated regulatory developments.
If we are unable to effectively manage these risks-such as ensuring adequate model performance, maintaining robust governance and security controls, adapting to evolving legal frameworks or meeting stakeholder expectations-our operational resilience, compliance posture, financial performance or reputation may be adversely affected.
Compliance risks
Evolving global data-protection and privacy requirements may expose us to legal, operational, and reputational risks if we are unable to consistently meet stringent obligations across our clinical, commercial, marketing, and genetic-data activities.
QIAGEN is exposed to an increasingly complex landscape of global
data-protection and privacy requirements that govern how personal, customer, clinical-study and genetic information is collected, processed, stored and used across our operations. These regulatory frameworks-including the General Data Protection Regulation (GDPR), China's Health and Medical Research Ethics Committee (HGRAC) guidelines for clinical-study data, regional privacy laws in EMEA and APEC, and evolving standards governing sensitive
genetic-data environments-continue to expand in scope and enforcement intensity. As our activities involve handling significant volumes of personal and, in some cases, highly sensitive information across diverse functions, any shortcomings in our data-governance practices could expose us to legal, operational, and reputational risks.
Data-privacy exposure arises in multiple parts of our business. Within clinical-research settings, our data-management processes must conform to
stringent obligations for handling personally identifiable information from study participants, and non-compliance with these rules-including those under GDPR and HGRAC-could lead to sanctions, delays, or limits on the conduct of studies. In our commercial operations in EMEA the U.S. and APEC, the collection, storage, and use of customer data remain subject to strict regulatory requirements, and risks may arise if security measures or employee training do not uniformly meet the standards required to prevent unauthorized access or inadvertent disclosure. Our marketing activities introduce further exposure when external data sets or purchased contact lists are used to expand our customer base; ensuring that these data sources are compliant with the GDPR, CCPA or other regional laws requires verification processes that, if not rigorously executed, could result in unlawful processing, regulatory action or invalidation of campaign efforts.
Certain business processes carry heightened privacy considerations. In our Human Identification Devices (HID) business, the GEDmatch platform processes
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raw genetic data, creating additional legal exposure if platform practices, user expectations, consent structures or data-sharing rights diverge from evolving privacy requirements.
If despite our controls we fail to comply with applicable data-protection laws or are perceived to have mishandled personal, customer, clinical-study or genetic information, we could face class action law suits, substantial fines, mandatory corrective actions, investigations, restrictions on data use and obligations to modify or suspend certain activities. In addition, any breach of trust-including through data-privacy incidents, regulatory findings, litigation, or gaps discovered during audits-could harm our reputation, weaken customer relationships, reduce participation in genetic or clinical initiatives, and limit the effectiveness of our commercial programs.
Although we have implemented controls such as data-management standard operating procedures, privacy-governance frameworks, consent-verification mechanisms, system filters that prevent non-compliant marketing outreach, GDPR-aligned event-data processes, platform-specific safeguards for genetic information, and structured incident-response procedures, we might be exposed to potential risks. The fragmented nature of global regulations, ongoing changes in enforcement practices, and the heightened sensitivity of certain data sets mean that we may continue to face exposure that could adversely affect our operations, financial position, or stakeholder confidence.
We may be subject to costly patent litigation, intellectual property disputes or licensing requirements that could impact our operations and financial performance.
The biotechnology and Life Sciences industries are highly litigious regarding patents and intellectual property rights, particularly as competitors develop technologies based on common platforms. We are aware that third parties hold patents related to sample and assay technologies, some of which are closely related to those we use.
From time to time, we receive inquiries regarding potential patent infringement. While we actively monitor developments and believe our technologies do not
infringe third-party rights, there is no guarantee that we will not face legal challenges. If a dispute arises, we may be required to:
Modify or discontinue certain products or processes
Obtain costly licenses, which may not be available on favorable terms or at all
Engage in lengthy and expensive litigation to defend against infringement claims or enforce our own patents
Additionally, proceedings before regulatory bodies such as the U.S. Patent and Trademark Office or the International Trade Commission may be necessary to determine the validity or scope of patents. Unfavorable rulings or settlement obligations could negatively impact our business, financial condition and competitive position.
Intellectual property litigation can be costly and time-consuming, diverting management resources and potentially leading to significant financial liabilities. Any adverse outcomes could materially affect our results of operations and market position.
Unethical behavior and non-compliance with laws by our sales representatives, consultants, commercial partners, distributors or employees could seriously harm our business.
Our operations include doing business in countries with a history of corruption and involve transactions with foreign governments. These factors may increase the risks associated with our international activities. We are subject to the U.S. Foreign Corrupt Practices Act (FCPA), the U.K. Bribery Act and other laws that prohibit improper payments or offers of payments to foreign governments and their officials and political parties by business entities for the purpose of obtaining or retaining business. We have operations, agreements with third parties and sales in countries known to experience corruption. Further international expansion may involve increased exposure to these types of practices. Our activities in these countries and others create risks of unauthorized payments or offers of payments, non-compliance with laws or other unethical behavior by any of our employees, consultants, sales agents or
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distributors, that could be in violation of various laws, including the FCPA, even though these parties are not always subject to our control.
Our policy is to implement safeguards to discourage these or other unethical practices by our employees and distributors, including online and in-person employee trainings, periodic internal audits and standard reviews of our distributors. However, our existing safeguards and any future improvements may not prove to be effective, and our employees, consultants, sales agents or distributors may engage in conduct for which we might be held responsible. Violations of the FCPA and other laws may result in criminal or civil sanctions, which could be severe, and we may be subject to other liabilities, which could negatively affect our business, results of operations and financial condition.
We depend on patents and proprietary rights that may fail to protect our business. Our success depends to a large extent on our ability to develop proprietary products and technologies and to establish and protect our patent and trademark rights in these products and technologies. As of December 31, 2025, we owned 280 issued patents in the United States, 214 issued patents in Germany and 1,569 issued patents in other major industrialized countries. In addition, as of December 31, 2025, we had 353 pending patent applications, and we intend to file applications for additional patents as our products and technologies are developed.
The patent positions of technology-based companies involve complex and uncertain legal and factual questions, with laws on patent coverage and enforceability subject to change. U.S. patent applications remain secret until issued, and scientific or patent literature publications lag behind discoveries. Thus, there is no guarantee that patents will be granted from our applications or, if granted, that they will be broad enough to protect our technology. Issued patents may be challenged, invalidated or circumvented, potentially diminishing our competitive advantage and revenue as patents expire and competitors develop similar products.
Some products use third-party licensed patents and technologies, which provide competitive advantages but impose commercialization and sublicensing
obligations. Non-compliance could convert exclusive licenses to non-exclusive or terminate them, leading to a loss of competitive edge and revenue.
We also protect trade secrets and proprietary know-how through confidentiality agreements with employees and consultants. However, these agreements may not offer meaningful protection or adequate remedies for unauthorized use or disclosure, and trade secrets could become known or independently developed by competitors.
Collaborations with academic researchers and institutions may result in third parties acquiring rights to inventions developed during these partnerships.
Obtaining regulatory approval and complying with evolving regulations is costly and time-consuming, potentially affecting our ability to commercialize products and generate sales.
Operating in a highly regulated global environment exposes us to ongoing uncertainty around approvals and compliance. Regulatory expectations continue to shift across major markets, requiring continuous investment in product development, documentation, quality systems, and monitoring.
Changes in regulations or interpretations may:
Slow or block product approvals or modifications
Increase compliance and operational costs
Limit or interrupt the sale of certain products
Many of our key offerings fall under strict medical-device and related regulatory frameworks. Failure to meet evolving requirements-whether in quality systems, labeling, documentation, or post-market obligations-could result in penalties, restrictions, or operational disruptions.
Additionally, products currently sold for research-use-only may become subject to new regulatory expectations, requiring additional steps before they can continue to be marketed.
Overall, regulatory evolution remains a material factor that can affect timelines, costs, and market access across our portfolio.
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Our business exposes us to potential product liability.
Our product marketing and sales involve inherent product-liability risks. Although we currently face no significant claims, future claims may arise, particularly if product defects, quality issues or failures in our manufacturing and control processes result in non-conforming products or performance concerns. Misuse or perceived misuse of our products-including in sensitive forensic and human-identification settings-could also lead to litigation or reputational harm.
We must comply with laws governing product safety and the handling of hazardous substances. Accidental contamination, chemical exposure or injury-related incidents could result in liability, regulatory action or financial impact.
Financial risks
Changes in tax laws, regulatory interpretations or reductions in government tax incentives could increase our effective tax rate, impact our financial flexibility, and adversely affect our results of operations.
Our effective tax rate benefits from partially tax-exempt income through intercompany operating and financing structures as well as regional tax rate variations across our global operations. The statutory corporate tax rate in the Netherlands is 25.8%, but income or losses in other jurisdictions may be taxed at higher or lower rates.
Recent global tax reforms, including the OECD's Pillar Two framework, introduce a 15% global minimum tax that could significantly impact multinational businesses, including QIAGEN. The Netherlands has formally enacted Pillar Two legislation, with certain provisions effective January 1, 2024, and others effective as of January 1, 2025. However, ongoing discussions among the OECD and participating countries continue to shape its implementation, creating uncertainty regarding administrative rules and compliance requirements.
In addition to OECD-driven changes, shifts in U.S. tax policy due to political uncertainty could lead to corporate tax rate adjustments, changes in transfer pricing regulations and limitations on deductions for interest and foreign-related
expenses. These changes could increase our tax burden, affect our cash tax payments and limit our ability to repurchase common shares without incurring adverse tax consequences.
Furthermore, tax authorities or regulatory bodies, such as the European Commission, may challenge our tax positions, transfer pricing arrangements or tax credit eligibility, potentially resulting in additional tax liabilities. These developments could materially impact our financial results, cash flow and ability to accurately forecast tax-related expenses.
Our debt obligations may impact our financial condition and flexibility.
We carry significant debt with service obligations and restrictive covenants that may limit our financial flexibility. High indebtedness increases the risk of default, restricts our ability to borrow additional funds and could impact our ability to generate sufficient cash flow to meet interest payments and debt covenants. If we are unable to secure working capital, new financing or equity funding, we may need to delay or reduce research and development investments.
Our debt levels could:
Limit our ability to make required debt payments
Restrict access to financing for operations, capital expenditures or debt service
Reduce flexibility in responding to industry changes
Increase vulnerability to economic downturns
Managing our debt effectively is critical to maintaining financial stability and business continuity.
Our business may require substantial additional capital, which may not be available on acceptable terms, or at all.
Future capital needs will depend on factors such as:
Marketing, sales and customer support expenses
Research and development investments
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Facility expansion
Acquisitions of technologies, products or businesses
Product demand and operational costs
Debt repayment or refinancing
Hedging activities and tax obligations
We expect to meet short-term capital needs through cash flow from operations and cash on hand. As of December 31, 2025, we had $1.4 billion in longterm debt and may choose to refinance these obligations.
If our existing resources become insufficient, we may need to raise funds through public or private debt or equity financing. However, funding may not be available on favorable terms, potentially requiring us to reduce or delay research and development, production, marketing, capital expenditures or acquisitions, negatively impacting our business. Additionally, issuing equity or convertible securities could result in shareholder dilution.
Our strategic equity investments may result in losses.
We make strategic investments in businesses as opportunities arise, but these investments may result in losses. We periodically evaluate their carrying value based on factors such as recent stock transactions, financial statements and market conditions. However, valuation fluctuations-driven by factors beyond our control-may impact our financial results.
Assessing the fair value of non-marketable Life Science investments is inherently subjective, and if actual outcomes differ from assumptions, we may be required to write down investments, leading to potential charges against earnings. There is no guarantee that these investments will yield long-term benefits.
Our ability to accurately forecast quarterly results is impacted by the timing of customer purchases, which are often concentrated in the final weeks or days of a quarter.
Many customers delay purchase decisions until late in the quarter as they assess budget availability and business needs. Additionally, revenue timing from
companion diagnostic partnerships can be unpredictable, further complicating forecasts.
While we have historically relied on customer purchasing patterns to project sales, deviations due to market fluctuations, economic conditions or changing procurement trends can result in significant differences between projected and actual results.
Due to these factors, we may not have sufficient real-time visibility to adjust forecasts accurately. If sales fall short of expectations, the market price of our Common Shares could be adversely affected.
An impairment of goodwill and intangible assets could reduce our earnings.
At December 31, 2025, our consolidated balance sheet included $2.7 billion of goodwill and $824.1 million of intangible assets. Goodwill arises when the purchase price of an acquisition exceeds the fair value of net assets, while intangible assets represent finite-lived assets such as patents or trademarks.
We test goodwill for impairment annually or when events indicate potential impairment. Intangible assets are reviewed for impairment when changes in circumstances suggest their carrying value may not be recoverable. These reviews are often conducted at an asset group level, which for goodwill currently applies to the entire company.
If impairment is identified, we must immediately record a charge to earnings, which could adversely impact our financial results.
External risks
Global economic uncertainty, rising rates, and geopolitical tensions may disrupt markets and supply chains, adversely affecting our operations and financial performance.
Our global operations are exposed to a broad range of macroeconomic, geopolitical and regulatory uncertainties that could adversely affect our business, financial condition and results of operations. Changes in global economic conditions-including inflationary pressures, tightening monetary policies, fluctuating energy prices, rising interest rates and volatility in financial
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markets - may influence customer purchasing behavior, impact access to capital, and increase operating costs across our value chain. Shifts in trade policies, import duties, and tariff regimes, including those arising from evolving U.S.- China relations or regional policy actions, may create additional cost burdens or restrictions on the flow of goods, potentially affecting supply chain stability and market access.
Geopolitical developments, including regional conflicts, terrorist attacks, sanctions, and sudden policy shifts, can disrupt global markets, weaken supply chains and contribute to increased uncertainty in countries where we operate or where our suppliers and customers are located. Recent conflicts and geopolitical tensions have demonstrated the potential for sudden changes in trade routes, logistics availability, and energy costs, as well as heightened risks of cyber disruption and political instability. These conditions may also amplify operational challenges for suppliers and third-party logistics partners, further affecting product availability or delivery timelines.
At the same time, we operate in a complex international tax and regulatory environment that continues to evolve. Changes in national tax reforms, international frameworks, or divergent local interpretations may require adjustments to our compliance processes and could influence effective tax rates or create additional reporting obligations. Broader policy developments-including sanctions, trade restrictions, or regulatory tightening in certain jurisdictions-may impact strategic planning and overall market predictability.
If these economic, geopolitical, trade or regulatory pressures intensify, or if our ability to respond to such developments is limited, we may experience increased costs, reduced demand, supply chain interruptions, or constraints on commercial activities. These developments may also influence the timing of investment decisions, affect operational resilience, or alter stakeholder confidence. Individually or collectively, these factors could adversely impact our business performance, financial results or long-term strategic objectives.
We may encounter delays in receipt, or limits in the amount, of reimbursement approvals and public health funding, which may negatively impact our ability to grow revenues in the healthcare market or our profitability.
Our growth and profitability in the healthcare and diagnostics markets are influenced by the pace, scope, and consistency of reimbursement approvals and public health funding.Delays or limits in reimbursement approvals and public health funding may hinder our revenue growth and profitability in the healthcare and diagnostics markets. Our ability to expand depends heavily on the pace and consistency of reimbursement decisions from government agencies, private insurers, and other payors. These decisions require extensive scientific and economic evidence, can be slow and resource-intensive, and are not guaranteed to be favorable or sustained.
Payors have become increasingly cautious about covering new diagnostic technologies, often limiting coverage or exerting pricing pressure. Insufficient or variable reimbursement levels may constrain adoption, require pricing adjustments, and negatively affect margins. Many customers also rely on reimbursement support to drive market uptake, while global payors continue to pursue cost-containment measures that could reduce reimbursement rates.
In the United States, ongoing policy uncertainty-including potential changes to the Affordable Care Act-may delay customer purchasing decisions. Under the Protecting Access to Medicare Act (PAMA), Medicare rates for certain diagnostic tests are tied to private-payor pricing, a system that has historically reduced reimbursement levels. Although recent legislation has delayed further PAMA-related cuts until 2027 and updated the reporting year to better reflect current pricing, future rate-setting remains uncertain. Proposed reforms, such as the RESULTS Act, could influence future methodologies, but no lasting solution has been enacted.
As a result, continued pressure on reimbursement rates may limit market expansion and adversely affect our operating results.
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Reduction in research and development budgets and government funding may result in reduced sales.
Our customers include pharmaceutical and biotechnology companies, academic institutions, and government and private laboratories. Demand for our products is influenced by fluctuations in research and development budgets, which can be impacted by funding availability, industry mergers,
shifting spending priorities and institutional policies. Any significant reduction in Life Sciences research and development spending could adversely affect our financial performance.
The pharmaceutical and biotechnology industries have undergone significant restructuring and consolidation in recent years. Further mergers may result in customer loss, reducing demand for our products and negatively impacting our results.
We also sell to universities, government laboratories and private foundations, many of which rely on government grants, particularly from agencies like the
U.S. National Institutes of Health (NIH), the largest source of Life Sciences funding in the country. While research funding has increased in recent years, future levels remain uncertain due to federal and state budget constraints. Government funding decisions, which are subject to unpredictable political processes, can cause purchasing delays and impact our sales.
Efforts to reduce budget deficits have previously included cuts to NIH and other global research agencies. A reduction in government funding for Life Sciences research could significantly impact our business and results of operations.
Competition could reduce our sales.
The markets for our products are highly competitive. Many competitors have greater financial, operational, sales, marketing and research and development resources. They may develop new technologies that compete with or render our products obsolete and could gain regulatory approval from agencies such as the U.S. Food and Drug Administration (FDA) and international regulators.
Competitors offering superior technology, cost-effective solutions or faster regulatory approval could adversely impact our sales and operations.
Our business growth depends on converting users from competing products to our sample and assay technologies. However, switching suppliers can be time-consuming and costly, as customers must integrate new products into their workflows. If we fail to be first to market with innovative solutions, our competitive position and sales may suffer.
Additionally, in commercial clinical diagnostics, we often compete with laboratory-developed tests (LDTs) created by our customers. Converting users from LDTs to our commercial assays remains a challenge, which may impact our market adoption and revenue.
We rely on collaborative commercial relationships to develop and/or market some of our products.
Our long-term strategy includes forming strategic alliances and marketing arrangements with academic, corporate and other partners for developing, commercializing and distributing our products. We may face challenges in negotiating these collaborations and maintaining them, and partners might develop competing products.
Our Precision Diagnostics business collaborates with pharmaceutical and biotech companies to co-develop companion diagnostics for their drugs. The success of these programs depends on our partners' commitment, clinical trial outcomes and regulatory approvals. Sales of companion diagnostics are closely tied to the commercial success of the related drugs.
Marketing QIAGEN products often relies on joint ventures or distributorships, especially in emerging markets where we partner with local companies. The success of these partnerships impacts our sales and profitability in these regions.
Real or perceived defects in or misuse of our products could adversely affect our results of operations, growth prospects and reputation.
We sell our products in over 160 countries, directly or through partners. Due to our extensive operations, tracking end-user usage can be challenging. Misuse or perceived misuse of our products could harm our reputation and customer trust, impacting market acceptance.
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Our customers, particularly in law enforcement and government, use our products for critical applications like forensic testing and human identification. They have low tolerance for defects, which could interfere with justice administration and damage forensic evidence. Defects or misuse, real or perceived, could lead to lost sales, increased service and replacement costs, reputational damage, customer loss, liability for damages and resource diversion, adversely affecting our business.
If our products are used unethically or unlawfully, it could harm our reputation and operations. We strive to ensure ethical and lawful use but cannot guarantee against misuse claims. Allegations of misuse, even if unfounded, could damage our reputation.
Our brand and reputation are crucial for business success. Maintaining them depends on delivering high-quality products and services. Negative reviews or publicity, especially in media, could harm our reputation and sales, adversely affecting our business and financial results.
Stock and shareholder risks
Fluctuations in results may impact the market price of our common shares.
Our operating results can vary significantly from quarter to quarter and year to year, influenced by multiple factors, including:
Demand for our products and customer purchasing cycles
Timing of research budgets and commercialization efforts
Government funding allocations affecting customer spending
Regulatory approvals and research and development activities
Sales and marketing expenses, as well as exit activities
New product launches by us or competitors
Competitive market conditions and macroeconomic trends
Exchange rate fluctuations affecting international revenue
We set expense levels based on anticipated sales trends, but actual sales and earnings may deviate from expectations, leading to variability in financial performance. As a result, our quarterly and annual results may not be indicative of future performance. If our results fail to meet or exceed analyst or investor expectations, the market price of our common shares could decline.
Our common shares may have a volatile public trading price.
The market price of our common shares has been highly volatile since our initial public offering in September 1996. Our shares have been listed on the New York Stock Exchange since January 10, 2018, after previously trading on Nasdaq. Over the past two years, our stock price has ranged from $37.63 to
$51.88 and from €32.50 to €46.21 on the Frankfurt Stock Exchange. In addition to overall stock market fluctuations, factors that may have a significant impact on the price of our common shares include:
New product launches or technological advancements by us or competitors
Changes in collaborations or partnerships
Quarterly financial performance and comparisons with peer companies
Regulatory, tax or patent law changes
Developments in intellectual property rights
Government funding for Life Sciences research
General market trends in diagnostics, pharmaceuticals and biotechnology
Foreign exchange rate fluctuations
The stock market has experienced extreme price and volume fluctuations, particularly affecting technology-based companies, often unrelated to their operating performance. These broad market swings may negatively impact the price of our common shares.
Management Report
QIAGEN N.V. | IFRS Annual Report 2025 Financial Statements Sustainability Statement Other Information Appendices Page 40
Future sales and issuances of our common shares could adversely affect our stock price.
The future sale or issuance of a large number of our common shares could negatively impact their market price. Dutch law allows a company to issue shares up to its authorized share capital as specified in its Articles of Association. Our authorized share capital is €9 million, divided into
410.0 million common shares, 40.0 million financing preference shares and
450.0 million preference shares, each with a €0.01 par value. As of December 31, 2025, approximately 216.9 million common shares were outstanding, with an additional 11.4 million reserved under stock plans, including shares subject to outstanding awards. Furthermore, up to 27.1 million shares may be issued upon conversion of debt. Most of our outstanding common shares can be sold without restriction, except those held by affiliates, which have resale limitations.
Shareholders could be subject to unfavorable tax treatment.
The tax treatment of an investment in our common shares may vary depending on the jurisdiction in which a shareholder is subject to tax, the shareholder's particular circumstances and the manner in which the shares are held. Changes in tax laws, regulations, administrative guidance or interpretations in relevant jurisdictions, possibly with retroactive effect, could adversely affect the tax consequences of the ownership or disposition of our common shares. In addition, tax authorities could challenge the treatment applied by shareholders or intermediaries. Any such developments could result in unfavorable tax treatment for shareholders, including in respect of dividends, capital gains, withholding, transfer or other taxes, and could adversely affect the value of, and return on, an investment in our common shares.
In addition, for U.S. federal income tax purposes, we could be classified as a passive foreign investment company, or PFIC, in any taxable year if either 75% or more of our gross income is passive income or 50% or more of the value of our assets is attributable to assets that produce passive income or are held for the production of passive income. Based on our income, assets and activities for 2025, we do not believe that we were a PFIC for U.S. federal income tax purposes, and we do not currently expect to become a PFIC in the foreseeable future. However, the determination of PFIC status is made annually and
depends on the composition of our income, assets and activities from time to time, as well as, in part, on the value of our assets, including goodwill, which may be affected by changes in the market price of our common shares.
Accordingly, there can be no assurance that we will not be classified as a PFIC for the current taxable year or any future taxable year, or that the IRS will not challenge any determination we make with respect to our PFIC status. If we were classified as a PFIC, U.S. holders of our common shares could be subject to adverse U.S. federal income tax consequences.
Provisions of our Articles of Association and Dutch law and an option we have granted may make it difficult to replace or remove management and may inhibit or delay a takeover.
Our Articles of Association require a two-thirds shareholder vote, representing over 50% of issued share capital, to suspend or dismiss Managing and Supervisory Directors against their wishes. If proposed by the joint Supervisory and Managing Boards, a simple majority is sufficient. Shareholders may also overrule Board nominations with the same two-thirds vote and share capital threshold. To prevent hostile takeovers, our Supervisory Board can issue preference shares if a third party acquires 20% or more of share capital or is deemed an "adverse person." This may discourage bids or lead to negotiations for better terms.
In 2004, we granted the Dutch foundation Stichting Preferente Aandelen QIAGEN the option to acquire preference shares equal to all outstanding common shares minus one to block or delay an unfavorable change of control. The foundation must act in our and stakeholders' interests when exercising this option. Key restrictions on the Foundation's ability to prevent or delay a change of control include the following:
protective shares may be issued only after a third party has publicly announced an offer; and
any such protective stake may be held for a maximum period of two years, after which the Foundation must reduce its holding to below the 30% voting rights threshold.
Disclaimer
Qiagen NV published this content on April 30, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 30, 2026 at 17:08 UTC.