REPLIGEN CORP (RGEN) Business

ITEM 1. BUSINESS

The following discussion of our business contains forward-looking statements that involve risks and uncertainties. When used in this report, the words “intend,” “anticipate,” “believe,” “estimate,” “plan” and “expect” and similar expressions as they relate to us are included to identify forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements and are a result of certain factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report on Form 10-K (“Form 10-K”).

References throughout this Form 10-K to “Repligen Corporation”, “Repligen”, “we”, “us”, “our”, or the “Company” refer to Repligen Corporation and its subsidiaries, taken as a whole, unless the context otherwise indicates.

Overview

Repligen Corporation is a global life sciences company that develops and commercializes highly innovative bioprocessing technologies and systems that increase efficiencies and flexibility in the process of manufacturing biological drugs.

As the overall market for biologics continues to grow and expand, our primary customers – global biopharmaceutical companies, contract development and manufacturing organizations and other life science companies (integrators) – face critical production cost, capacity, quality and time pressures. Built to address these concerns, our products help set new standards for the way biologics are manufactured. We are committed to inspiring advances in bioprocessing as a trusted partner in the production of critical biologic drugs – including monoclonal antibodies (“mAbs”) and mAb derivatives like antibody drug conjugates, recombinant proteins, RNA-based therapeutics and vaccines and cell and gene therapies (“C”) – that are improving human health worldwide.

We currently operate as one bioprocessing business, with a comprehensive suite of products to serve both upstream and downstream processes in biological drug manufacturing. Building on over 40 years of industry expertise, we have developed a broad and diversified product portfolio that reflects our passion for innovation and the customer-first culture that drives our entire organization. We continue to capitalize on opportunities to maximize the value of our product platform through both organic growth initiatives (internal innovation and commercial leverage) and targeted acquisitions.

Our corporate headquarters are located in Waltham, Massachusetts, with additional administrative and manufacturing operations worldwide. A majority of our 19 manufacturing sites are located in the United States (including California, Massachusetts, New Hampshire, New Jersey and New York). Outside the United States, we have manufacturing sites in Estonia, France, Germany, Ireland, the Netherlands, Sweden, and Taiwan.

Our Products

Our bioprocessing business is comprised of four main franchises: Filtration (including Fluid Management); Chromatography; Process Analytics; and Proteins.

Since 2012, we have purposely built a highly diversified portfolio of products offered under these franchises, developing high-value technologies that enable more efficient drug manufacturing processes for our customers, through internal research and development (“R&D”) programs and strategic acquisitions. We are committed to sustainable innovation and have earned a reputation as an innovation leader in bioprocessing. We have consistently introduced disruptive new products that solve for specific bioprocessing challenges faced by customers. Our growth strategy continues to expand our geographic scope and customer base and broaden the applications of our technologies.

To support our sales goals for these products, we make ongoing investments in our commercial organization, our R&D programs, our business systems and our manufacturing capacity. We regularly evaluate and invest in these areas as needed to ensure timely deliveries and to stay ahead of customer demand for our products.

The majority of our revenue is derived from consumable and/or single-campaign (“single-use”) product sales, though we have grown our hardware and equipment offerings in recent years. The customization, scalability and plug-and-play convenience of these products, and in many cases the closed nature of our technologies, make them ideal for use in biologics manufacturing processes where contamination risk is a critical concern of our customers.

Shifting to Integrated Solutions

Since 2012, we have completed 15 acquisitions across our four franchises, building a base of technology assets that we can improve upon and/or develop next-generation versions of through our internal R&D team. Our acquisition strategy focuses on differentiated technology, while considering the potential for integration with our internally-developed technologies, across products and franchises, and the financial impact.

Our commercial approach is shifting from selling individual products to offering our broad portfolio to customers with integrated solutions that can support entire unit operations, the management of fluids between unit operations, and in-line advanced analytics.

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For example, providing filtration systems for production and harvest steps (upstream), and connecting those to chromatography and filtration systems for purification and formulation steps (downstream).

Our Franchises & Products

Filtration: Filtration is our largest franchise with the broadest product offering covering upstream and downstream technologies. Key products include:

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XCell® ATF Cell Retention Systems. Our XCell ATF (Alternating Tangential Flow) systems are used in upstream bioprocessing for perfusion applications including seed train intensification (N-1), production bioreactor (N), intensified fed-batch, and continuous manufacturing to improve volumetric productivity. The XCell ATF system enables the cell culture to be run continuously, with cells being retained in the bioreactor, fresh nutrients (cell culture media) being fed into the reactor continuously, and clarified biological product and cell waste being removed (harvested) continuously. The cells are maintained in a consistent nutrient-rich environment and can reach cell densities two- and three-times higher than those achieved by standard fed-batch culture. As a result, product yield is increased, which improves facility utilization and can reduce the size of a bioreactor required to manufacture a given volume of biologic drug product. XCell ATF systems are available in a wide range of sizes (both stainless steel and single use) that can easily scale from laboratory use through full production with bioreactors as large as 5,000 liters.

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Flat Sheet Cassettes. Our TangenX® product portfolio includes flat sheet (“FS”) tangential flow filtration (“TFF”) cassettes that are used primarily in downstream, ultrafiltration processes, e.g., biologic drug concentration, buffer exchange and formulation processes, our single-use SIUS® line including our reusable PRO line of cassettes, and our TangenX SC Device, the industry's first holder-free, self-contained (“SC”) TFF device. Our TangenX FS TFF cassettes feature high performing-membrane chemistries that offer superior selectivity for a wide range of applications.

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Hollow Fiber Consumables. We offer a wide range of hollow fiber (“HF”) filters across sizes, surface areas, and membrane chemistries to facilitate easy scale-up from process development (“PD”) to commercial production. Our hollow fiber filters are gentle on shear-sensitive products. In addition, we have security of supply, competitive lead times, and manufacture with a high degree of automation.

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Tangential Flow Filtration Systems: KrosFlo® TFF. Our KrosFlo TFF systems are designed for scalability from research to commercial manufacturing (up to 5,000 liters) volumes, flexibility between HF and FS cassettes filter formats, and the ability to use the same system in different unit operations while deploying ready-to-use application-specific flow paths. With the same software, hardware, controls and cGMP compliance built into every system, and with pre-assembled flow kits for error-free installation, the KrosFlo RS platform offers operational simplicity that can easily be scalable from lab- through production-scale use. We offer our fully automated GMP compliant RS systems including the benchtop scale RS10, RS20, pilot scale RS30, RS40 and production scale RS50 systems. In addition, we offer process development scale TFF systems like the KR2i/KMPi/FS-15 & FS-500. In 2022, we launched KrosFlo KR2i RPM for low-volume, high concentration applications. This was the first-to-market TFF system to incorporate real-time process monitoring for in-line protein concentration management. By coupling KrosFlo TFF and FlowVPX functionality, customers can benefit from improved process control and efficiency, while reducing process risk by ensuring accurate concentration throughout the TFF process.

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Fluid Management. Following a variety of acquisitions including most recently Metenova, we offer a comprehensive portfolio of fluid management products including bags, tubing, valves, totes, carts and mixers. In 2025, we launched the ProConnex® MixOne RG-X, a novel single-use mixer which combined Metenova’s mixing technology and components from a variety of our fluid management acquisitions. In addition to selling our fluid management components, many of these solutions are inputs into our ProConnex® flowpaths, consumables for our systems, enabling unique design features and providing us with vertical integration.

Chromatography: Our chromatography franchise includes a number of products used in downstream purification, development, manufacturing and quality control of biological drugs. Key products include:

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OPUS® Pre-Packed Columns. OPUS Pre-Packed Columns (“PPC”) are disposable, single-use or campaign-use columns that replace customer self-packed glass or stainless steel columns for downstream purification. The platform uses consistent material of construction across column formats, enabling scalable workflows from PD through clinical and commercial-scale manufacturing. OPUS columns are delivered sealed and pre-packed with the customer’s choice of resin and dimensional configuration, reflecting the platform’s open, resin-agnostic, and configurable model. By designing OPUS columns as a technologically advanced and flexible option for the purification of biologics from process development through clinical and commercial-scale manufacturing, Repligen has become a leader in the PPC market. The OPUS platform spans a range of formats, including RoboColumn®, MiniChrom®and ValiChrom® in 0.5-2.5cm inner diameter, used for PD and scale down studies. For clinical and commercial manufacturing, the platform offers OPUS columns in range of 2.5-80cm inner diameter, including OPUS 80R, currently the largest available PPC on the market.

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OPUS PPC provides plug-and-play convenience by reducing labor, equipment and facility requirements, while also delivering cost savings and consistent purification performance across development and commercial manufacturing. Repligen supports OPUS customers through manufacturing and customer-facing facilities in both the United States and Europe. Our production process offers a premier ability to pack a broad range of commercially available resins according to customer choice and specifications.

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KRM™ Chromatography Systems. Through our acquisition of ARTeSYN in 2020, we gained state-of-the-art, configurable chromatography systems that can integrate a wide range of hardware, components and consumable products to simplify bioprocessing operations for our customers. Our KRM chromatography systems are precision engineered for high product recovery (low hold-up volumes), high bioactivity (less stress on the product of interest) and reduced risk of deviation (simple changeovers and pre-assembled flow kits). The KRM systems contain closed single-use flow paths (less risk of contamination and product loss) and other advanced fluid management technologies (over-molded connectors, pump heads, filters and pressure sensors), intuitive software and process-enabled analytics technology.

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Additional chromatography products include our ELISA test kits, used by quality control departments to detect and measure the presence of leached Protein A, other affinity ligands, and/or growth factor in the final product.

Process Analytics: Through the acquisition of C Technologies, Inc. in 2019, we offer downstream process analytical technology (“PAT”) solutions. We added to our Analytics portfolio in 2025 through the acquisition of 908 Devices Inc.’s (“908 Devices”) bioprocessing portfolio, which brought upstream PAT solutions. In 2025, we rebranded our Analytics offerings to PATsmart™. Our products include:

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Downstream PAT. Our downstream portfolio consists of two main offerings, both of which feature slope spectroscopy. Use of slope spectroscopy systems delivers multiple process benefits for our biopharmaceutical manufacturing customers, compared to traditional ultraviolet-visible (“UV-Vis”) approaches. Key benefits include: the elimination of manual dilutions and sample transfers from process development/manufacturing to labs, rapid time to results (minutes versus hours), improved precision, built-in data quality for improved reporting and validation, and ease of use. Our PATsmart SoloVPE® slope spectroscopy system is the industry standard for offline and at-line absorbance measurements for protein concentration determination in process development, manufacturing and quality control settings. In 2025, we launched the SoloVPE PLUS System. The SoloVPE PLUS System is engineered to offer unparalleled accuracy, speed, and ease-of-use for at-line UV-Vis concentration measurement in complex biological production workflows, from process development to cGMP manufacturing. Our PATsmart FlowVPX slope spectroscopy system is our next-generation FlowVPE launched at the beginning of 2021 and designed to meet the rigors of GMP requirements. FlowVPX offers reliable real-time results with integrated ease for concentration measurements during GMP manufacturing of biologics. In addition, we offer our KrosFlo® RPM™ Systems with integrated FlowVPX® Technology.

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Upstream PAT. In March 2025, we acquired 908 Devices’ desktop portfolio of four devices for bioprocessing process analytical technology (“PAT”) applications. Products acquired from 908 Devices include PATsmart MAVERICK and PATsmart MAVEN for real-time monitoring and control of critical bioprocess parameters; PATsmart REBEL, an at-line cell culture media analyzer; and PATsmart ZipChip, a high-resolution sample separations device used in the characterization of product quality attributes.

Proteins: Our proteins franchise is represented by our affinity ligands and resins used to purify a wide range of biological drugs including monoclonal antibodies and new modalities, along with cell culture growth factor products. Key products include:

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Protein A Affinity Ligands. Protein A ligands are the essential “binding” component of Protein A affinity chromatography resins used in the purification of virtually all mAb-based drugs on the market or in development. We historically manufactured multiple forms of Protein A ligands under long-term supply agreements with a variety of major life sciences companies. These life sciences companies in turn sell their chromatography resins to end users (pharmaceutical developers and manufacturers). In June 2018, we entered into an agreement with Navigo Proteins GmbH (“Navigo”) for the exclusive co-development of multiple affinity ligands for which Repligen holds commercialization rights. We manufacture and exclusively supply the first of these ligands, NGL-Impact® A, to Purolite, for use with their Purolite™ Praesto™ Jetted A50 Protein A resin product. In September 2021, the Company and Navigo successfully completed co-development of a novel affinity ligand that addresses aggregation issues associated with pH sensitive antibodies and Fc-fusion proteins. We are manufacturing and supplying this ligand, NGL-Impact® HipH, to Purolite. We have a long-term supply agreement with Purolite for NGL-Impact and potential additional affinity ligands that may advance from our Navigo collaboration. In October 2022, we extended our long-term supply agreement with Purolite through 2032 and broadened its scope to include affinity ligands targeting antibody fragments in addition to those targeting mAbs and Fc-fusion proteins. This extension and product line expansion aligns with our Proteins strategy and supports the acceleration in market adoption of the Praesto® affinity resin portfolio. It provides Purolite with exclusive access to mAb fragment ligands developed at Avitide (as defined below), in addition to the NGL portfolio developed at Navigo. Repligen will continue to receive access to Purolite's leading-edge base bead technology, as we proceed with the development and

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commercialization of novel affinity resins focused on new modalities and C.

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AVIPure® Resins for New Modalities. In September 2021, we completed our strategic acquisition of Avitide, Inc. (“Avitide”), a market leader in affinity ligand discovery and development. This acquisition was a major step forward in building our Proteins franchise, moving Repligen into affinity resin solutions for C and other emerging modalities. In December 2024, we acquired Tantti Laboratory Inc. (“Tantti”), which helped accelerate our expansion into new modality markets with unique, scalable purification solutions tailored for larger molecule biologics. One of the key innovations emerging from Tantti's technology is our new HiPer™ base beads, specifically designed for these larger molecules. In addition to the launch of our first resin, AVIPure® dsRNA, in December 2024, we successfully introduced three new resins in December 2025: AVIPure® HiPer™AAV9, AVIPure® HiPer™AAV8, and HiPer™QA. Through Avitide and Tantti, we also offer custom ligand and resin development services.

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Growth Factors. To encourage greater cell growth and maximize overall output from bioreactors, manufacturers often introduce growth factors such as insulin into their cell culture media. Our range of cell culture growth factor additives includes LONG® R3 IGF 1, an insulin-like growth factor that has demonstrated up to 200 times more potency and twice the stability of insulin in cell cultures, leading to enhanced recombinant protein production during cell culture applications. We also offer LONG® EGF, a recombinant analogue of human epidermal growth factor, created to serve as a direct substitute for either native EGF or recombinant human EGF (“hEGF”) in therapeutic cell culture settings.

Corporate Information

We are a Delaware corporation with our global headquarters in Waltham, Massachusetts. We were incorporated in 1981 and became a publicly traded company in 1986. Our common stock is listed on the Nasdaq Global Market under the symbol “RGEN”. We have approximately 2,000 employees and operate globally with offices and manufacturing sites located at multiple locations in the United States, Europe and Asia. Our principal executive offices are located at 41 Seyon Street, Waltham, Massachusetts 02453, our website is www.repligen.com and our telephone number is (781) 250-0111.

2025 Acquisition

908 Devices PAT Portfolio

On March 4, 2025, the Company completed its acquisition of 908 Devices’ desktop portfolio of four devices for bioprocessing process analytical technology applications (“PAT Portfolio”, together with 908 Devices, the “908 Devices PAT Portfolio”). In connection with the transaction, Repligen also acquired facilities, employees, equipment and lease obligations for facilities. This transaction is referred to as the 908 Devices PAT Portfolio acquisition.

The addition of these desktop assets complements and strengthens Repligen’s differentiated PAT Portfolio that provides its biopharmaceutical and contract development and manufacturing organization (“CDMO”) customers with actionable insights to optimize development processes and improve manufacturing efficiencies.

Our Market Opportunity

Bioprocessing Addressable Market

The global addressable market for bioprocessing products is estimated to be approximately $20 billion of which we estimate Repligen’s addressable market to be approximately $13 billion at year end 2025. This market includes bioprocessing products used to manufacture therapeutic antibodies, recombinant proteins and vaccines, as well as new modalities like cell and gene therapies (“Cs”).

Monoclonal Antibody Market

Antibody-based biologics alone accounted for approximately $300 billion of global biopharma revenue in 2025. Industry sources project the mAbs market to grow in the high single digits through 2030, driven by new approvals and expanded clinical uses for marketed antibodies, as well as the emergence of biosimilar versions of originator mAbs. As of December 31, 2025, over 200 mAbs were approved by the U.S. Food and Drug Administration (“FDA”) to treat a wide range of diseases. Biological R&D remains robust, with more than 3,000 active mAb clinical trials ongoing to address a wide range of medical conditions.

In addition to investments in the discovery and development of novel biologic drugs, there has been substantial investment in follow-on products (biosimilars) by generic and specialty pharmaceutical as well as large biopharmaceutical companies. Development of follow-on products accelerated as the first major mAbs came off patent in the European Union and United States. Due to the high cost of biologic drugs, many countries in developing and emerging markets have been aggressively investing in biomanufacturing capabilities to supply lower cost biosimilars for the local markets. For both originator and follow-on biologics manufacturing, Repligen products are well-positioned to enable greater manufacturing flexibility, production yields and lower costs through improved process efficiencies.

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New Modalities Markets

New modalities encompass cell and gene therapy, RNA based therapeutics and vaccines, and other non-mAb based biological drugs. New modalities have emerged in the past few years to become a rapidly growing area of biological drug development, with an estimated global market of greater than $19 billion in 2025, and over 2,000 industry clinical trials underway at year-end 2025 according to industry sources. Statements by the FDA are supported by industry reports that estimate annual revenue growth of over 20% for new modalities markets over the next several years. The scientifically advanced therapeutic approaches have unique manufacturing challenges that many of our products can help address. We believe we are well positioned to participate in new modalities production.

Our Strategy

We are focused on the development, production and commercialization of highly differentiated, technology-leading systems and solutions that address specific pressure points in the biologics manufacturing process and deliver substantial value to our customers. Our products are designed to optimize our customers’ workflow to maximize productivity and we are committed to supporting our customers with strong customer service and applications expertise.

We intend to build on our history of developing market-leading solutions and delivering strong financial performance through the following strategies:

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Continued innovation. We plan to capitalize on our internal technological expertise to develop products that address unmet needs in upstream and downstream bioprocessing. We continue to invest in platform and derivative products to support our proteins, filtration, chromatography and process analytics franchises. We plan to strengthen our existing product lines with complementary products and technologies, including fluid management products, that are designed to allow us to provide customers with an integrated, more automated and more efficient manufacturing process on one or more measures including flexibility, convenience, time savings, cost reduction and product yield.

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Increasing our position. With our growing portfolio of innovative products, we see an opportunity to increase our position within our existing markets driven by cross-selling and geographic expansion. Our key accounts team focuses on selling to a targeted group of large pharmaceutical and CDMO customers with the objective of further penetrating these accounts by increasing both the number of product lines they purchase and their overall volume. In addition, our broader commercial team is incentivized to cross-sell our entire portfolio. Geographically, we are investing in the Asia Pacific region to increase our commercial presence by selectively building our team in this region.

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Leveraging our mix. We see two key opportunities for mix to help drive growth. First, we believe we are under-indexed to commercial volumes relative to our peers. As customers progress through the clinical trial process, we believe our commercial volumes should naturally grow. In addition, we see an opportunity for some of our products to get specified into existing commercial processes to further accelerate this shift. Secondly, we believe our products are well-suited for new modality applications, which represent a growing portion of our customers’ pipelines.

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Targeted acquisitions. We intend to continue to selectively pursue acquisitions of innovative technologies and products that address customer pain points. These can either be complementary to our existing portfolio of products or help us better serve our customers across their pipeline of modalities.

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Operational efficiency. We seek to expand operating margins through volume leverage, manufacturing productivity and operating expense discipline. We plan to invest in information technology modernization to support our global operations, optimizing resources across our global footprint to maximize productivity.

Research and Development

Our R&D activities are focused on developing new high-value bioprocessing products across all of our franchises. We strive to continue to introduce truly differentiated products that address specific pain points in the biologics manufacturing process. Our commitment to innovation is core to the Repligen culture and our success as a company.

Sales and Marketing

Our sales and marketing strategy supports our objective of strengthening our position as a leading provider of products and services, addressing upstream, downstream and quality control needs of bioprocessing customers in the biopharmaceutical industry.

Our Commercial Team

To support our sales goals for our direct-to-consumer products, we have invested in our commercial organization. Our global commercial organization consists of approximately 390 employees as of December 31, 2025. Geographically, about 200 members of our commercial team are located in North America, 110 are in Europe and 80 are in Asia-Pacific (“APAC”) regions.

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Our bioprocess account managers are supported in each region by bioprocess sales specialists with expertise in filtration, chromatography or process analytics, and by technically trained field applications specialists and field service providers, who can work closely with customers on product demonstrations, implementation and support. We believe that this model helps drive further adoption at our key accounts and also open up new sales opportunities within each region.

Ligand Supply Agreements

For our proteins franchise, we are committed to be a partner of choice for our customers with distributor and supply agreements in place with large life sciences companies such as Purolite.

Significant Customers and Geographic Reporting

Customers for our bioprocessing products include major life sciences companies, CDMOs biopharmaceutical companies, diagnostics companies and laboratory researchers.

The following table represents the Company’s total revenue by geographic area, based on the location of the customer:

(1) Rest of the world consists of countries in Central and South America and Africa.

During the years ended December 31, 2025, 2024 and 2023, no single country other than the United States accounted for more than 10% of total revenues. There was no revenue from customers that represented 10% or more of the Company's total revenue for the years ended December 31, 2025, 2024 and 2023.

Human Capital

Employees

Repligen performs in a highly competitive industry and recognizes that our continued success hinges upon our ability to attract, develop and retain an inclusive team of talented individuals. We place high value on the satisfaction and well-being of our employees and operate with fair labor standards and industry-competitive compensation and benefits globally.

As of December 31, 2025, we employed approximately 2,000 full-time and part-time employees. Each of our employees has signed a confidentiality agreement. None of our U.S. employees are covered by collective bargaining agreements. We have one collective bargaining agreement with two unions that covers approximately 130 employees in Sweden, comprising approximately 6% of our total workforce. In France, 55 employees are under the relevant national and local collective bargaining agreements for metallurgy, comprising approximately 3% of our total workforce.

Code of Business Conduct and Ethics

Repligen is committed to conducting business in accordance with the highest ethical standards. This means how we conduct ourselves and our global work is more than just a matter of policy and law; it’s a reflection of our core principles. Our Code of Business Conduct and Ethics reflects Repligen’s five core principles – (1) trustworthiness, (2) respectfulness, (3) responsibility, (4) fairness and (5) corporate citizenship. Our Code of Business Conduct and Ethics applies to all Repligen employees, including those who are integrated into the Company through acquisitions. The full text of our Code of Business Conduct and Ethics is posted on our website and can be found at www.repligen.com.

Inclusive Workforce

Repligen maintains a resolute commitment to fostering an inclusive workplace. We have rigorous, established talent acquisition processes, as well as training and employee engagement resources, including inclusive workforce initiatives, to drive the principles of “belonging” for all employees at all levels of our organization starting with our Board of Directors (the “Board”) and our Leadership team.

We believe that our employees should reflect the communities in which we live, work, and serve. In our hiring practices, we strive to hire the most qualified person for the job by ensuring that qualified, inclusive slates of applicants are identified and considered for all roles within our workforce. As a result of our ongoing commitment to, and focus on, talent identification, recruitment, hiring, engagement, development, and succession planning, we have been particularly effective in building a strong workforce with a broad and deep talent pipeline.

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Employee Engagement and Development

Our goal is to develop and maintain a talented, engaged and inclusive workforce that has a positive impact on our performance and on our customers. We regularly conduct engagement surveys to gain insight on employee perspectives. Additional channels for employee engagement include Company-wide all-hands meetings led by our Chief Executive Officer (“CEO”) and site town halls ran by site leaders. We are committed to colleague recognition, which includes acknowledging, appreciating and celebrating each other's contributions and achievements. Our CEO-led all-hands meetings serve as a platform for CEO awards and platinum awards, which reward and recognize both teams and individual colleagues who have made significant and notable contributions to Repligen's success. We also offer a range of programs to develop our managers and enhance our leadership across the Company. Our professional development efforts are aimed at increasing organizational talent and capabilities as well as identifying and developing potential successors for key leadership positions.

Health, Safety and Well-Being

We actively promote the safety, health and well-being of our employees and end users of our products. Creating a culture where all employees feel supported and valued is paramount to our corporate mission. Our well-being goals are for employees to physically thrive, flourish mentally and emotionally, be socially connected and achieve financial security. We are proud to provide all of our full time employees in the United States with access to an employee assistance program (“EAP”). Our EAP offers employees and their eligible dependents counseling and well-being resources 24 hours a day, seven days a week by phone, online or via the mobile site. Our environmental health and safety policy advances our vision of zero workplace incidents and our efforts to reduce our environmental impacts.

Repligen Performance System

In 2022, we formalized the Repligen Performance System (“RPS”), to provide the tools and a framework for engaging employees across the organization to continuously improve operational performance, with a focus on product quality, customer lead times, material supply, production costs and sustainability. Through a standard implementation network, all teams were empowered to implement just-do-it process improvements, solve priority problems through stand-up meetings and improve key processes through kaizen events. We believe RPS improved our teams' ability to continuously resolve customer challenges, enhance product quality and improve operational efficiencies. The impact of RPS has been seen in productivity savings, customer lead-time reductions, manufacturing capacity expansions, product quality improvements and significant reductions in manufacturing scrap at several key sites.

Sustainability - Environmental, Social and Governance Matters

Our Commitment to Sustainability

We believe our commitment to sustainability topics across all our global facilities matters and is an important part of creating long-term business value for all stakeholders. We are deeply committed to corporate responsibility and transparency, and we continue to factor sustainability into our business decisions and integrate its core principles into our daily operations.

In establishing a formal approach to sustainability, we joined the United Nations Global Compact in support of its Ten Principles related to human rights, labor, the environment, and anti-corruption. The actions we have taken while building and implementing our robust sustainability strategy, supported by core pillars focused on Environmental, Social and Governance (“ESG”) issues, demonstrates our long-term commitment to being a responsible global corporate citizen. Together, we are advancing our ESG initiatives and taking steps to engage stakeholders throughout our upstream and downstream value chain.

Our Reporting Frameworks

We have become an active participant in the sustainability reporting ecosystem through our voluntary disclosures in our annual corporate sustainability reports. These align with the greenhouse gas protocol, the United Nations Global Compact (“UNGC”), the International Financial Reporting Standards Sustainability Alliance (which now includes the former Sustainability Accounting Standards Board (“SASB”) and the Task Force on Climate-related Financial Disclosures (“TCFD”)) and are in accordance with the Global Reporting Initiative (“GRI”).

Oversight of Sustainability and ESG Matters

In 2025, the Board transferred oversight of the sustainability function to the Audit Committee to better align strategies and to support increasing sustainability-related regulatory requirements. The Audit Committee meets regularly and reviews and advises on strategy, initiatives and reporting, and apprises the full Board in order to ensure that our strategy, initiatives and reporting align with the Company’s mission.

Our Vice President of Sustainability and ESG, under strategic direction of our CEO and Chief Operating Officer, is responsible for the development and implementation of our expanding sustainability strategy, initiatives and reporting. In collaboration with all key business functions, the mandate of this globally focused role is to consider our existing initiatives, understand stakeholder

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perspectives, identify business-relevant areas of opportunity to make positive impacts, and work collaboratively to drive initiatives designed to accelerate our progress and drive business value.

Intellectual Property

We are committed to protecting our intellectual property through a combination of patents, trade secrets, copyrights and trademarks, as well as confidentiality and material transfer agreements. As further described below, we own or have exclusive rights to more than 250 active patent grants and 150 pending patent applications in the United States and other foreign jurisdictions including Australia, Canada, China, France, Germany, India, Japan, South Korea, Sweden, Taiwan and the United Kingdom. Some patent rights that are the result of collaboration or sponsorship from third parties may be limited by agreements or other contractual rights.

We require each of our employees, consultants, business partners, potential collaborators and customers to execute confidentiality agreements upon the commencement of an employment, consulting, business relationship, or product related audit or research evaluation.

Filtration

For our filtration franchise, our patent grants include coverage for ATF filtration, TFDF and TFF HF and FS systems, membranes, filters, mixers, valves, controllers, flow paths and single-use technologies. We continually seek to improve upon these technologies and have multiple new patent filings including patents covering next generation TFDF filters, next generation ATF filtration technologies, and proprietary reduced cost system components.

Through the Metenova acquisition in 2023, our patent portfolio includes innovative upstream technologies such as magnetic low shear mixers and carboy assemblies.

Chromatography

Our patent portfolio covers various aspects of our commercial products and industry, including certain unique methods and features of our OPUS PPC, macroporous chromatography resin, dissolvable microcarrier structures and related exo-technology, valves, integrated sensors and integrated flow path systems.

Process Analytics

Through our 2025 acquisition of the 908 Devices PAT Portfolio, we gained patent rights to a wide range of process analytic technologies, including Raman, mass spectroscopy and diffusion membranes. We continue to develop our various spectroscopy analytical tools using our slope spectroscopy technology.

Proteins

We own patents and file patent applications globally on innovative affinity ligands that target a variety of antigens and on Protein A-based affinity ligands.

Trademarks

We procure and maintain trademark registrations globally for various product brands and services. We prioritize our “housemarks”, (e.g., Repligen, the stylized “R” logo, Spectrum, TangenX, Polymem, Metenova, Tantti, etc.), and ensure continued protection in strategic territories globally. We also have trademark registrations for various product lines, including OPUS, XCell, XCell ATF, TFDF, KrosFlo, SIUS, ProConnex, Spectra/Por, NGL-Impact, SoloVPE, FlowVPE, FlowVPX, RPM, XO, Metenova MixOne and AVIPure, that provide valuable company recognition and goodwill with our customers.

We have a comprehensive branding policy that includes trademark usage guidelines to ensure Repligen trademarks are used in accordance with our worldwide registrations and we actively police any unauthorized trademark usage as well as enforce the rights we have under our trademarks.

Licensing Agreements

We have entered into multiple licensing and collaboration relationships with third-party business partners to fully exploit our technology and advance our bioprocessing business strategy. For example, we entered into a 15-year exclusive License Agreement with Daylight (the “Daylight Agreement”), giving us exclusive license and commercialization rights to use certain technology and intellectual property in bioprocessing. See Note 12, “Commitments and Contingencies” in the notes to the consolidated financial statements, included in Part IV, Item 15, Exhibits and Financial Statement Schedules, in this Annual Report on Form 10-K for more information on this license agreement.

Competition

Because of our large range of products and services, we compete with a number of competitors across a variety of businesses and markets, including manufacturers, distributors and other service providers. Our bioprocessing products compete on the basis of

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innovation, value proposition, performance, quality, cost effectiveness, and application suitability with numerous established technologies. Additional products using new technologies that may be competitive with our products may also be introduced.

Manufacturing

A majority of our 19 manufacturing sites are located in the United States (including California, Massachusetts, New Hampshire, New Jersey and New York). Outside the United States, we have manufacturing sites in Estonia, France, Germany, Ireland, the Netherlands, Sweden, and Taiwan.

The protein products we provide are manufactured at our sites in Waltham, Massachusetts and Lund, Sweden. Native Protein A ligands and our growth factor products are manufactured in Lund, while recombinant Protein A ligands are manufactured in Lund. Our primary chromatography assembly and manufacturing sites are located in Waltham, Massachusetts, Ravensburg, Germany and Breda, the Netherlands. Our primary filtration manufacturing sites, including manufacturing of fluid management systems, products and consumables, are located in Marlborough, Massachusetts; Rancho Dominguez, California; Clifton Park, New York; Hopkinton, Massachusetts; Waterford, Ireland; Juri, Estonia and Toulouse, France. Our facility in Marlborough, is focused on XCell ATF, FS TFF, Spectrum HF products, while in Rancho Dominguez the focus is on Spectrum HF, TFDF and ProConnex products. Our process analytics products are manufactured in Bridgewater, New Jersey, Braunschweig, Germany and Marlborough, Massachusetts. As part of our capacity expansion activities, we have added a site in Hopkinton, Massachusetts that serves as an assembly center for single-use products and the capacity to manufacture our protein products. With our six acquisitions since the beginning of 2021, we gained manufacturing sites in Molndal, Sweden (Metenova), Toulouse, France (Polymem), Lebanon, New Hampshire (Avitide), Taoyuan City, Taiwan (Tantti) and Braunschweig, Germany (908 Devices). We undertook restructuring activities in 2023 and 2024 that continued into 2025 and included consolidating a portion of our manufacturing operations between certain U.S. locations and discontinuing the sale of certain product SKUs. In addition, we continuously evaluate the net realizable value of finished goods and raw materials, including those secured during the 2020-2022 pandemic period. As a result of these activities, we closed manufacturing sites in Newton, New Jersey, Branchburg, New Jersey, Dallas Texas, Simi Valley, California, Auburn, Massachusetts and Oceanside, California.

We utilize our facilities in Lund, Sweden to carry out fermentation and recovery operations, and purification, immobilization, packaging and quality control testing of our protein-based bioprocessing products. Our facilities located in Waltham, Massachusetts; Marlborough, Massachusetts; Lund, Sweden; Ravensburg, Germany; Bridgewater, New Jersey; Clifton Park, New York; and Rancho Dominguez, California among other sites, are ISO® 9001:2015 certified and maintain formal quality systems to maintain process control, traceability, and product conformance. Additionally, our facility in Shrewsbury, Massachusetts is ISO® 13485:2016 certified. We practice continuous improvement initiatives based on routine internal audits as well as external feedback and audits performed by our partners and customers. In addition, we maintain a business continuity management system that focuses on key areas such as contingency planning, security stocks and off-site storage of raw materials and finished goods to ensure continuous supply of our products.

Available Information

We maintain a website with the address www.repligen.com. We are not including the information contained on our website as a part of, or incorporating it by reference into, this Form 10-K. We make available free of charge through our website our Form 10-Ks, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, including exhibits and amendments to these reports, as soon as reasonably practicable after we electronically file such materials with, or furnish such materials to, the Securities and Exchange Commission (“SEC”). We also provide corporate governance, such as our Code of Business Conduct and Ethics and other information, including our 2024 Sustainability Report, free of charge, through our website.

Our filings with the SEC may be accessed through the SEC’s Electronic Data Gathering, Analysis and Retrieval system at www.sec.gov.