BIO-RAD LABORATORIES, INC. (BIO) Business

ITEM 1. BUSINESS

General

Bio-Rad Laboratories, Inc. (referred to in this report as “Bio-Rad,” “we,” “us,” “the Company,” and “our”) is a multinational life science and clinical diagnostics company that develops, manufactures, and markets a broad portfolio of instruments, systems, reagents, and consumables.

We have direct operations in over 36 countries outside the United States through subsidiaries focused on sales, customer service, and product distribution. In certain locations outside and within these countries, our sales efforts are supplemented by distributors and agents.

Description of Business

Business Segments

Bio-Rad operates in two industry segments designated as Life Science and Clinical Diagnostics. Both segments operate worldwide. Our Life Science segment and our Clinical Diagnostics segment generated approximately 40% and 60%, respectively, of our consolidated net sales for the year ended December 31, 2025. We generated approximately 40% of our consolidated net sales for the year ended December 31, 2025 from the U.S. and approximately 60% from our international locations, with Europe being our largest international region.

3

Life Science Segment

Our Life Science segment develops, manufactures, and markets instruments, systems, reagents, and consumables used to separate, purify, characterize, and quantify biological materials, including cells, proteins, and nucleic acids. These products are utilized in research and biopharmaceutical laboratory environments, as well as in biopharmaceutical manufacturing, quality control processes, food safety testing, and science education applications. We serve the research market, where our products are applied to support the progression of scientific discovery from early research through clinical and applied use. We offer a broad portfolio comprising thousands of life science products distributed globally. We estimate the worldwide sales of products in the markets we serve to be approximately $19 billion. Our principal life science customers include universities and medical schools, industrial research organizations, government agencies, pharmaceutical manufacturers, biotechnology companies, and food producers and testing laboratories.

Clinical Diagnostics Segment

Our Clinical Diagnostics segment designs, manufactures, markets, and supports diagnostic test systems, informatics solutions, test kits, and specialized quality controls for clinical laboratories in the global diagnostics market. Our products address targeted segments within the in vitro diagnostics (“IVD”) market, with a focus on differentiated diagnostic applications.

We supply several thousand products supporting more than 300 clinical diagnostic tests within the IVD market. We estimate the worldwide sales of products in the markets we serve to be approximately $16 billion. IVD tests are performed outside the human body and are used to identify and measure substances in patient tissue, blood, or urine samples.

Our clinical diagnostics portfolio consists of reagents, instruments, and software, which are typically provided as integrated systems to support standardized laboratory workflows and reproducible test results. Revenue in this business is largely recurring, as laboratories generally standardize on specific testing platforms that rely on a supplier’s instruments, reagents, and consumables. As a result, an installed base of diagnostic systems typically generates recurring revenue through ongoing sales of test kits and consumables for each sample processed.

Our principal clinical diagnostics customers include hospital laboratories, diagnostic reference laboratories, transfusion laboratories, and physician office laboratories.

Raw Materials and Components

We utilize a wide variety of chemicals, biological materials, electronic components, machined metal parts, optical parts, computing and peripheral devices. Most of these materials and components are available from numerous sources, and in 2025, we generally did not experience difficulty in securing adequate supplies. In certain instances, we acquire components and materials from a sole supplier. For more discussion relating to the risks to our supply of raw materials, including the difficulty of securing adequate supplies, please see “Item 1A, Risk Factors” of this Annual Report.

Patents, Trademarks and Licenses

We own over 2,100 U.S. and international patents and numerous trademarks. We also hold licenses under U.S. and foreign patents owned by third parties and pay royalties on the sales of certain products under these licenses. In addition, we also receive royalties for licenses of our intellectual property. We view these patents, trademarks and license agreements as valuable assets; however, we believe that our ability to develop and manufacture our products depends primarily on our knowledge, technology and special skills rather than our patent, trademark and licensing positions.

4

Seasonal Operations

Our business is not inherently seasonal. However, the European custom of concentrating vacation during the summer months usually tempers third quarter sales volume and operating income.

Sales and Marketing

We conduct our global operations through an extensive direct commercial organization, employing approximately 770 sales and sales management personnel worldwide as of December 31, 2025. Our sales teams are primarily composed of experienced industry professionals with scientific training, and we operate dedicated, segment-aligned sales organizations supporting each of our operating segments. We believe this direct commercial model enables effective portfolio coverage, deeper customer engagement, and the development of long-term customer relationships.

We also use a range of sales and marketing intermediaries ("SMIs") in our international markets. The types of SMIs we utilize are distributors, agents, brokers and resellers. We have programs and policies in place with our SMIs requiring their compliance with all applicable laws, including adhering to our anti-corruption standards to ensure a transparent sale to our customers.

Our customer base is broad and diversified. Our global customer base includes (1) university and research institutions; (2) hospital, public health and commercial laboratories; (3) diagnostic manufacturers; and (4) companies in the biotechnology, pharmaceutical, chemical and food industries.

Our sales are affected by a number of external factors. For example, a number of our customers, particularly in the Life Science segment, are substantially dependent on government grants and research contracts for their funding. In our Clinical Diagnostic segment, we are constrained by government reimbursement for many of our products.

Competition

The markets served by our product groups are highly competitive. Our competitors range from early-stage companies to large multinational corporations with substantial resources and global reach. We focus our competitive efforts on market segments where the technology, performance, and application of our products provide customers with differentiated capabilities that offer specific advantages over the competition.

Our Life Science segment does not face the same competitors for all of its products due to the breadth of its portfolio and specialization of its product lines. Major competitors in this market include Becton Dickinson, Danaher, Merck KGaA, Qiagen N.V. and Thermo Fisher Scientific. We compete primarily based on meeting performance specifications, technical support, and offering comprehensive solutions.

Major competitors for our products in the Clinical Diagnostics segment include Abbott Laboratories, Becton Dickinson, bioMérieux, Danaher, DiaSorin, Werfen, QuidelOrtho, Roche, Siemens Healthineers, Thermo Fisher Scientific and Tosoh. We compete across a variety of attributes including quality, service and product portfolio.

Research and Development

We conduct extensive research and development activities in all areas of our business. Research and development has played a major role in Bio-Rad’s growth and is expected to continue to do so in the future. Our research teams are continuously developing new products and new applications for existing products. In our development of new products and applications, we interact with scientific and medical professionals at pharma and biopharma companies, universities, hospitals, medical schools, and elsewhere within our industry. In addition, we regularly invest in companies that are engaged in the development of new technologies that either complement or expand our existing portfolio of products. As of December 31, 2025, we had approximately 790 employees worldwide focused on research and development, including degreed scientists, engineers, software developers and other technical support staff.

5

Regulatory Matters

The development, testing, manufacturing, marketing, post-market surveillance, distribution, advertising and labeling of certain of our products (primarily diagnostic and donor screening products) are subject to regulation in the United States by the Center for Devices and Radiological Health ("CDRH") and/or the Center for Biologics Evaluation and Research ("CBER") of the U.S. Food and Drug Administration ("FDA") and in other jurisdictions by state and foreign government authorities. FDA regulations require that certain new products have pre-marketing notification (“510(k)”) or approval (“PMA” or Biologics License Application – “BLA”) by the FDA and require certain products to be manufactured in accordance with FDA’s current Good Manufacturing Practice ("cGMP") regulations, to be extensively tested and to be properly labeled to disclose test results and performance claims and limitations.

A clinical trial is generally required to support a PMA or BLA application and can be required for a 510(k) clearance or a de novo authorization. Conducting clinical trials in a clinical environment enrolling human subjects and/or related samples to validate the investigation device requires compliance with Good Clinical Practice ("GCP") and regulatory guidelines, which is a complex and costly activity that may require use of outsourced resources that specialize in planning and conducting the clinical trial for the medical device manufacturer.

The European Union (“EU”) has adopted the EU in-vitro Diagnostics Regulation (the “EU IVDR”), which imposes stricter requirements for the marketing and sale of in-vitro diagnostics products (as compared to the predecessor in-vitro Diagnostics Directive ("IVDD")), including in the areas of clinical evaluation requirements, quality systems, economic operators and post-market surveillance. Bio-Rad's IVD products currently meet the applicable requirements of the EU IVDR.

Our manufacturing facilities, as well as those of certain suppliers, are subject to periodic inspections by the FDA and other regulatory bodies to verify compliance with regulatory requirements. Similar inspections are performed by Notified Bodies to verify compliance to applicable International Organization for Standardization (“ISO”) standards (e.g. ISO 13485:2016), requirements under the Medical Device Single Audit Program ("MDSAP") applicable to regulatory requirements of Australia, Brazil, Canada, Japan and the U.S. and/or medical device regulations and requirements from the countries in which we distribute product and other specified audits by regulatory authorities. If a regulatory body were to find that we or certain suppliers have failed to comply with applicable regulations (e.g. recordkeeping, reporting of adverse events), it could institute a wide variety of enforcement actions, ranging from issuance of a warning or untitled letter to more severe sanctions, such as mandatory product recalls or seizures, civil penalties, consent decrees, injunctions, criminal prosecution, operating restrictions, partial suspension or shutdown of production, refusal to permit importation or exportation, refusal to grant, or delays in granting, clearances or approvals or withdrawal or suspension of existing clearances or approvals. Any of these actions could have an adverse effect on our business.

We are also subject to additional regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which we conduct our business. Such laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, privacy and security and physician sunshine laws and regulations. If our operations are found to be in violation of any such laws or any other governmental regulations that apply to us, we may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, and exclusion from participation in federal and state healthcare programs and imprisonment.

6

Sales of our products will depend, in part, on the extent to which our products or diagnostic tests using our products will be covered by third-party payors, such as government health care programs, commercial insurance and managed healthcare organizations. These third-party payors are increasingly adjusting reimbursements for certain medical products and services. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost containment programs, including price controls and restrictions on reimbursement. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. Decreases in third-party reimbursement for our products or diagnostic tests using our products, or a decision by a third-party payor to not cover our products could reduce or eliminate utilization of our products and have a material adverse effect on our sales, results of operations and financial condition. In addition, healthcare reform measures have been and will be adopted in the future, any of which could limit the amounts that governments will pay for healthcare products and services, which could result in reduced demand for our products or additional pricing pressures.

As a multinational manufacturer and distributor of sophisticated instrumentation, we must meet a wide array of electromagnetic compatibility and safety compliance requirements to satisfy regulations in the United States, the European Union and other jurisdictions.

Our operations are subject to federal, state, local and foreign environmental laws and regulations that govern activities such as transportation of goods, emissions to air and discharges to water, as well as handling and disposal practices for solid, hazardous and medical wastes. In addition to environmental laws that regulate our operations, we are also subject to environmental laws and regulations that create liabilities and clean-up responsibility for spills, disposals or other releases of hazardous substances into the environment as a result of our operations or otherwise impacting real property that we own or operate. The environmental laws and regulations could also subject us to claims by third parties for damages resulting from any spills, disposals or releases resulting from our operations or at any of our properties.

These regulatory requirements vary widely among countries.

Human Capital Resources

At Bio-Rad, we consider our employees to be our most valuable asset, and critical to the effective development, manufacture, sale, distribution and servicing of our vast array of products and services. Our employees are essential to satisfying our customers’ needs for products to advance science and healthcare. At December 31, 2025, we had approximately 7,450 employees, the overwhelming majority of which are full-time employees. Our employees are located throughout the world with roughly 46% in the Americas, 36% in Europe, the Middle-East and Africa, and 18% in Asia Pacific. Our employees work in 37 different countries around the world. We are a diverse organization. Our differences offer new and unique ideas and perspectives. We foster a work culture that embraces the diverse experience and knowledge of every employee.

Compensation and Benefits

We provide a competitive total rewards program consisting of broad-based salary and bonus plans as well as annual stock grants to senior level employees. These programs combine to recognize and reward employees based on individual, group, and overall company performance. We provide competitive health and welfare programs which include medical, dental, vision and life insurance, a 401(k) plan, an employee stock purchase program, local pension plans, profit sharing, employee assistance, child and elder care programs, employee recognition and a host of other localized programs tied to the unique needs of our employees. Pay equity is an integral part of our compensation strategy. We have established ongoing processes and protocols to help us pay each individual employee appropriately based on the employee's skills, performance, experience, location, market practices, etc., regardless of race, gender, and other non-performance related attributes.

7

Health, Wellness and Safety

The health and welfare of our employees is of the highest importance to Bio-Rad. We prioritize, manage, and carefully track safety performance at all locations globally and integrate sound safety practices in every aspect of our operations. We provide work site hazard evaluations, workplace safety surveys, safety equipment selection, safety program reviews, chemical exposure monitoring, safety training, and disposal of hazardous chemical and infectious waste.

Training and Talent Development

We provide training programs for managers and employees to support their growth and development. Our management series of courses cover essential management and leadership learning to provide our managers with the necessary skills and experience needed to more effectively lead and develop their teams. In addition, available courses for employees help them to be more effective at work, enhance interpersonal effectiveness, and help them achieve their full potential. We also support employees’ professional development by providing a reimbursement program for qualified educational expenses.

Investment in Sartorius AG

Sartorius AG ("Sartorius") is an international laboratory and process technology provider for the biotech, pharmaceutical, and food industries. It operates in two divisions – Bioprocess Solutions Division and Lab Products & Services Division. Sartorius is headquartered in Gottingen, Niedersachsen, Germany and has voting ordinary shares as well as non-voting preference shares listed on XETRA and the Frankfurt Stock Exchanges.

As of December 31, 2025, we owned 12,987,900 ordinary voting shares and 9,588,908 preference shares of Sartorius, representing approximately 38% of the outstanding ordinary shares (excluding treasury shares) and 28% of the preference shares of Sartorius. As of December 31, 2025, the fair value of our investment in Sartorius was $5,669.2 million. We account for our investment in Sartorius at fair market value and do not include any of the financial information summarized below in our consolidated financial statements.

The following summarizes certain financial data of Sartorius as of and for the year ended December 31, 2024 (in millions).

8

(1) As disclosed in Sartorius's consolidated financial statements for the year ended December 31, 2024, prepared in accordance with the International Financial Reporting Standards (IFRS), the International Financial Reporting Interpretations Committee (IFRIC) Standards, and the International Accounting Standards Board (IASB) as required to be applied by the European Union, and based upon information publicly disclosed by Sartorius. Bio-Rad does not assume, and by way of referencing the financial data of Sartorius above shall not be deemed to assume, any responsibility or liability for any errors or omissions in the information publicly disclosed by Sartorius.

Refer to Sartorius’ 2024 Annual Report for further details, which can be found at https://www.sartorius.com/en/company/investor-relations/sartorius-ag-investor-relations. The Sartorius website and any information disclosed thereon are not incorporated by reference into this report.

The following graph reflects the changes in the Sartorius share price over the most recent five annual periods:

Available Information

Bio-Rad files annual, quarterly, and current reports, proxy statements, and other documents with the Securities and Exchange Commission ("SEC") under the Securities Exchange Act of 1934, as amended. The SEC maintains an Internet website that contains reports, proxy and information statements, and other information regarding issuers, including Bio-Rad, that file electronically with the SEC. The public can obtain any documents that we file with the SEC at http://www.sec.gov.

Bio-Rad’s website address is www.bio-rad.com. We make available, free of charge through our website, our Form 10-Ks, 10-Qs and 8-Ks, and any amendments to these reports, as soon as reasonably practicable after filing with the SEC. The information on our website is not part of this Annual Report on Form 10-K.