About QIAGEN N.V.

QIAGEN N.V. (QIAGEN) operates as a global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. QIAGEN conducts its business through subsidiaries around the world. The company’s sample technologies isolate and process deoxyribonucleic acid (DNA), ribonucleic acid (RNA) and proteins from blood, tissue and other materials. The company provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academic research, pharma and biotech companies, and applied applications, such as human identification / forensics and food safety). As molecular biology and genomic knowledge has grown to influence many areas of daily life, the company has expanded to serve the full spectrum of market needs, developing new instruments, consumables and digital solutions; partnering with researchers and pharmaceutical companies, and acquiring companies and technologies that best complement the company’s portfolio. The company’s growth strategy is anchored in its five pillars of growth: sample technologies, the digital PCR (Polymerase Chain Reaction) platform QIAcuity, the clinical PCR automation solutions QIAstat-Dx and NeuMoDx and the QuantiFERON technology platform used to detect diseases, such as latent tuberculosis. QIAGEN Products The company’s leadership in molecular research and testing solutions leverages the company’s product portfolio across a wide range of applications. These are grouped into two main categories: consumables and related revenues involve the company’s consumables kits, bioinformatics solutions, royalties, co-development milestone payments and services (88% of total net sales in 2022); and instruments and related services and contracts (12% of total net sales in 2022). QIAGEN Product Groups Sample Technologies Sample Technologies is the first of the company’s five pillars of growth and includes products involved in the first step of any molecular lab process. The company’s broad portfolio of Sample Technologies includes consumables and instruments used in sample collection, stabilization, storage, purification and quality control. Some of the company’s consumables are designed to run on its 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) laboratories, as well as clinical testing. Diagnostic Solutions Diagnostic solutions include the company’s molecular testing platforms and consumables covering three of the company’s Five Pillars of Growth, which are QuantiFERON, QIAstat-Dx and NeuMoDx, as well as Precision Diagnostics, which involves companion diagnostic co-development revenues from projects with pharmaceutical companies, regulated assays and solutions for laboratory developed tests. Additional areas include Oncology and Sexual & Reproductive Health for the detection of various diseases and for use in prenatal testing for the detection of infectious diseases and for other laboratory processes. PCR / Nucleic Acid Amplification PCR / Nucleic Acid Amplification involves the company’s research and applied PCR solutions and components. The product group includes another of the company’s Five Pillars of Growth: QIAcuity. The company offers optimized solutions for end-point PCR, quantitative PCR and digital PCR. The company’s kits, assays, instruments and accessories amplify and detect targets and streamline workflow for virtually any application. Genomics / NGS This product group includes the company’s universal NGS (next-generation sequencing) solutions for use with any NGS sequencer, as well as the full bioinformatics portfolio offered by QIAGEN Digital Insights. Other Revenues from various sources, including protein biology products, royalties, intellectual property and freight charges. Principal Markets The company sells its products to more than 500,000 customers in two broad customer groups: Molecular Diagnostics (clinical testing) and Life Sciences (academia, pharmaceutical R&D and applied testing). 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. The company offers 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. The company’s range of assays for diseases and biomarkers speed up and simplify laboratory workflow and standardize many 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 the company expects the market to provide significant growth opportunities. The company has 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. The company has more than 25 master collaboration agreements with pharmaceutical industry customers, some with multiple co-development projects. In 2022, the company continued to expand on these partnerships with new agreements, for example a new partnership with Neuron23 for the development of a companion diagnostic for Parkinson’s disease. Also, the company’s portfolio of assays was expanded following the FDA approval of a companion diagnostic for Mirati's therapy for Non-Small Cell Lung Cancer. Companion diagnostics move through clinical trials and regulatory approvals, along with the paired drugs, to commercialization and marketing to healthcare providers. Life Sciences The Life Sciences market includes governments and biotechnology companies – and researchers who use molecular testing and technologies and are generally served by public funding in areas, such as medicine and clinical development, forensics and exploring the building blocks of life. The company partners 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, government and law enforcement agencies. The company provides Sample to Insight solutions to academic and research institutions around the world. The company focuses on enabling researchers to use reliable, fast, highly reproducible and high-quality technologies, sometimes replacing time-consuming traditional or in-house methods. The company often partners with leading institutions on research projects and develop customized solutions, such as NGS panels for the digital sequencing of multiple gene targets. In the course of the COVID-19 pandemic, the company served increased demand from viral and vaccine researchers for RNA extraction, general PCR reagents and enzymes, and universal NGS solutions. The company is 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 and veterinary diagnostics. The company provides 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. The company has deep relationships with pharmaceutical and biotechnology companies. Drug discovery and 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. The company estimates that about half of its sales to these companies supports research, while the other half supports clinical development, including the stratification of patient populations based on genetic information. Also, QIAGEN Digital Insights solutions are widely used to guide pharmaceutical research. Geographic Markets The company markets products in more than 130 countries. In 2022, the top six growth markets—Brazil, India, China, South Korea, Mexico and Turkey—contributed approximately 13% of net sales. Sales and Marketing The company markets its products in more than 130 countries, mainly through subsidiaries in markets in the Americas, Europe, Australia and Asia with the greatest sales potential. Experienced marketing and sales staff, many of them scientists with academic degrees in molecular biology or related areas, sell the company’s products and support its customers. In many markets, the company has specialized independent distributors and importers. The company continues to drive the growth of its digital marketing channels - including the company’s website (www.qiagen.com), product-specific sites and social media. The company’s 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 the company’s customers' needs and enables customers to manage different activities in one central place. The company’s GeneGlobe Design & Analysis Hub (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 new hub brings next-level experiment planning, execution and follow-up to life science researchers, linking the company’s QIAGEN Digital Insights solutions with ordering of assays to accelerate research. The company uses a range of tools to provide customers with direct access to technical support, inform them of new product offerings, and enhance the company’s reputation for technical excellence, high-quality products and commitment to service. For example, the company’s technical service hotline allows existing or potential customers to discuss a wide range of questions about the company’s products and molecular biology procedures, online or via phone, with Ph.D. and M.Sc. scientists at QIAGEN. Frequent communication with customers enables the company to identify market needs, learn of new developments and opportunities, and respond with new products. The company also distributes publications, including its catalog, to existing and potential customers worldwide, providing new product information, updates, and articles about existing and new applications. In addition, the company holds numerous scientific seminars at clinical, academic and industrial research institutes worldwide and at major scientific and clinical meetings. The company conducts direct marketing campaigns to announce new products and special promotions, and the company offers personalized electronic newsletters and webinars highlighting molecular biology applications. For laboratories that frequently rely on the company’s 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 the company is automating this process with digital technologies. Easy-to-use online ordering, inventory monitoring and customer-driven changes make QIAstock an efficient system for providing ready access to the company’s products for the hundreds of customers worldwide who use this program. Intellectual Property, Proprietary Rights and Licenses As of December 31, 2022, the company owned 314 issued patents in the United States, 260 issued patents in Germany and 1,776 issued patents in other major industrialized countries. The company had 370 pending patent applications. The company’s policy is to file patent applications in Western Europe, the United States and Japan. Government Regulations The company has implemented the requirements set forth by the General Data Protection Regulation (GDPR), which took effect on May 25, 2018. GDPR and other EU data privacy and security laws impact the company’s business either directly or indirectly. Some of the company’s products are sold for research purposes in the United States, and labeled ‘For Research Use Only’ (RUO) or ‘for molecular biology applications’. The company’s Redwood City entity serves in some cases as a Business Associate to customers who are subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations. The company is subject to prosecution and/or administrative enforcement and increased civil and criminal penalties for non-compliance, including a new, four-tiered system of monetary penalties adopted under the Health Information Technology for Economic and Clinical Health Act (HITECH). The company is also subject to enforcement by state attorneys general who were given authority to enforce HIPAA under HITECH. The company has 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. Research and Development The company’s research and development expenses were largely unchanged at $189.9 million in 2022. History QIAGEN N.V. was founded in 1986.