MARAVAI LIFESCIENCES HOLDINGS, INC. (MRVI) Business

Item 1. Business

Description of Business

Maravai LifeSciences Holdings, Inc. (also referred to in this document as “Maravai,” “we,” “us,” “our” or “the Company”) is a life sciences company providing critical products and services to enable the development of drugs, therapeutics, vaccines, and diagnostics, and support research on human disease. Our customers include biopharmaceutical companies, emerging biotech firms, life science research organizations, academic research institutions and diagnostics companies.

Our comprehensive product portfolio addresses the critical stages of biopharmaceutical development, offering:

•complex nucleic acids for therapeutic, vaccine, and diagnostic applications;

•custom enzymes for research and diagnostic use; and

•antibody-based solutions to detect impurities during the production of biopharmaceutical products.

Business Segments and Products

We operate and report our business in two segments – TriLink, formerly referred to as Nucleic Acid Production, and Cygnus, formerly referred to as Biologics Safety Testing.

During fiscal year 2025, we renamed our reportable segments from Nucleic Acid Production and Biologics Safety Testing to TriLink and Cygnus, respectively. This change reflects updated segment naming to better align with our internal brand and operating terminology. There were no changes to the composition of our reportable segments, the nature of the products and services offered, or the manner in which the chief operating decision maker (“CODM”) evaluates the Company’s operating performance or allocates resources.

TriLink provides nucleic acid products and related services, including mRNA, oligonucleotides, CleanCap® mRNA capping technology, ModTail™ poly(A) tail modification technology, synthesis inputs, nucleoside triphosphates, specialty enzymes, and mRNA manufacturing services.

Cygnus provides biologics safety testing products and services, including host cell protein ELISA kits, impurity detection assays, viral clearance prediction tools, ancillary reagents, and custom analytical services.

TriLink (64% of Revenue for the Year Ended December 31, 2025)

We are a global provider of highly modified, complex nucleic acids and related products. We have recognized expertise in complex chemistries and products provided under exacting quality standards. Our core offerings include mRNA, our proprietary CleanCap® mRNA capping and ModTail™ poly(A) tail modification technologies, long and short oligonucleotides, oligonucleotide inputs, nucleoside triphosphates, custom nucleic chemistry, and specialty enzymes. We offer products for research use only (“RUO”) and, where applicable, materials manufactured under good manufacturing processes (“GMP”) to support preclinical, clinical and commercial applications. We also provide manufacturing services for discovery-scale and GMP mRNA synthesis.

mRNA. We develop and manufacture mRNA products to support therapeutic, including cell and gene therapies (“CGT”), and vaccine programs from preclinical development through clinical phases, including process scale-up and analytical development services. We offer both research-grade and GMP materials to support different phases of development.

mRNA Capping (CleanCap®). We offer our patented CleanCap® technology, which is designed to improve co-transcriptional capping efficiency and reduce uncapped mRNA species. CleanCap® analogs are sold as stand-alone reagents and may also be bundled with other raw materials such as nucleoside triphosphates (“NTPs”), our ModTail™ technology, and enzymes to support the synthesis of mRNA. CleanCap® is available in RUO-grade and GMP-grade for clinical and commercial applications.

Poly(A) tail modification (ModTail™). We offer poly(A) tail modification technology for mRNA called ModTail™. This proprietary technology increases overall protein expression and extends the duration of protein expression. ModTail™ mRNA is available as catalog products, and ModTail™ technology can be added to custom mRNA via our custom mRNA services. Our ModTail™ technology is compatible with CleanCap®, various base modifications, construct sizes, poly(A) tail lengths, as well as mRNA produced using enzymatic capping methods.

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Oligonucleotides. Our oligonucleotide products support applications including therapeutics, in vitro diagnostics, next-gen sequencing (“NGS”) and CRISPR-based gene editing (guide RNA). Many of our oligonucleotide products are custom manufactured DNA or RNA sequences, often highly modified and produced as RUO or under GMP conditions for use in development, clinical and commercial applications.

Oligonucleotide Synthesis Inputs. Our product offerings include reagents and supports for DNA and RNA oligonucleotide synthesis, labeling, modification and purification. Customers include oligonucleotide synthesis service providers, life science and biopharma companies, diagnostic companies, academic institutions and government organizations.

Nucleoside Triphosphates (NTPs). We manufacture NTPs used in polymerase chain reactions and sequencing reactions and in the manufacture of mRNA. NTPs may be unmodified, composed of the four standard bases, or modified to enhance particular biological properties for research or therapeutic applications. We offer NTPs in RUO and GMP-grade.

Custom Nucleic Acid Chemistry. We provide custom nucleotide chemistry synthesis services, including high purity NTPs, amidites and other novel molecules for diagnostic and therapeutic developers.

Specialty Enzymes. Enzymes are key inputs in nucleic acid production including in vitro transcription (“IVT”) workflows used to produce mRNA. We provide custom, scalable molecular biology enzymes across IVT, next-gen sequencing (“NGS”), life science and diagnostic applications. We provide our proprietary T7 enzyme for reducing double-stranded RNA (“dsRNA”) during IVT. We are vertically integrated, and our enzymes are incorporated into our CleanScript™ mRNA production workflow.

Manufacturing Services.

Discovery mRNA synthesis. We provide products and services for early-stage development, including custom mRNA constructs and process development services. These services can integrate with our CleanCap® cap analogs, ModTail tail technology, NTP products and IVT enzymes and have access to our analytical and QC method development.

GMP mRNA synthesis. We provide GMP mRNA manufacturing services for customers in clinical trials through commercial manufacturing. This includes process development and scale-up, regulatory submission support, and in-house analytical services for mRNA analysis and characterization.

Cygnus (36% of Revenue for the Year Ended December 31, 2025)

We provide products and services that enable the detection of impurities present in bioproduction. Our products are used during development and scale-up, during the regulatory approval process and throughout commercialization. We are recognized globally for assays that detect host cell proteins (“HCPs”) and other process-related impurities in drug product substances. Cygnus product categories include HCP ELISA kits, other process impurity and containment ELISA kits, viral clearance prediction kits, ancillary reagents and custom analytical services.

Our customers manufacture a broad range of biopharmaceutical products including monoclonal antibodies and recombinant proteins, both as novel biologics and biosimilars, recombinant vaccines, and cell and gene therapies. Viral vector manufacturing and other bioproduction processes require rigorous analytical testing for process-related impurities such as HCPs, host cell DNA, purification leachates, growth media additives and enzymes used during the purification processes.

HCP ELISA Kits. HCP ELISA kits are bioassays used to detect residual proteins from expression platforms used in bioproduction. HCPs constitute a major group of process-related impurities produced using cell culture technology no matter what cell expression platform is used. HCPs pose potential health risks for patients and the risk of failure of safety endpoints for drug manufacturers. When present in the administered product, even at low levels, HCPs can induce an undesired immune response, interfere with drug efficacy and impact drug stability. HCPs are a critical quality attribute for biologics safety testing development and must be adequately removed during the downstream purification process.

Other Impurity and Contaminant Kits. We offer kits for measuring Protein A and L leachates, growth media additives (such as bovine serum albumin), host cell DNA, residual endonuclease impurities in viral vector and vaccine preparations, and residual AAV ligands resulting from affinity purification method used for certain adeno associated virus (AAV)-based gene therapies.

Viral Clearance Prediction kits. We offer MockV® -based tools including the Minute Virus of Mice, the MockV® MVM kit and the CHO Retrovirus-like Particle, MockV® RVLP Kit, which are novel, proprietary viral clearance prediction tools that use a non-infectious “mock virus particle” mimicking the physicochemical properties of live virus that may be present endogenously in the drug substance or introduced during bioproduction. These kits enable manufacturers to conduct viral clearance assessments and predict outcomes in-house ahead of live viral clearance studies.

Ancillary Reagents. Our ancillary reagent products include antibodies, antigens, sample diluents, and other auxiliary products necessary to optimize applications for customer processes.

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Custom Services. We provide process-specific antibody and ELISA development, qualification and maintenance services, as well as orthogonal methods including antibody affinity extraction (AAE™), and mass spectrometry-based services for HCP antibody coverage, identification and quantification analyses.

Commercial

We have relationships with the following categories of customers: developers of therapeutics, cell and gene therapies and vaccines, other biopharmaceutical and life science research companies, academic institutions and molecular diagnostic companies. Our biopharmaceutical customers include startups, established biotechnology companies and large pharmaceutical companies developing enzyme replacement therapies, gene editing therapies, ex vivo therapies and vaccines.

We serve customers through direct and indirect sales in each business segment, with a primary focus on our biopharmaceutical and large diagnostics and commercial customers. We serve our academic customers via online tools, email and phone ordering as well as through key partnerships where our reagent products and services can be accessed through partnerships. We support all customers with in-field and in-house technical support, alliance and program management and customer service.

We address customers outside the United States with a combination of direct sales and distributor partners, supporting customers in approximately 60 countries.

Competition

We compete with a range of companies across our segments.

TriLink

Competitors include chemistry companies producing monomers and amidites, custom oligonucleotide manufacturers, mRNA-focused biotechnology companies, and CDMOs. For mRNA capping, competitors include providers of enzymatic capping solutions and in-house customer processes. For mRNA and GMP services, competitors include other mRNA manufacturers and CDMOs. For oligonucleotide synthesis inputs, competitors include large distributor-manufacturers, and for specialty enzymes, competitors include established life science enzyme providers.

Cygnus

Competitors include providers of impurity detection kits and companies offering custom assay development, including certain CROs and CDMOs.

Manufacturing and Supply

We occupy facilities in San Diego, California, Leland, North Carolina, Sterling, Virginia, and Jupiter, Florida, supporting manufacturing, analytical services, and distribution across our segments. Our supply chain is supported by a network of specialized suppliers and transportation partners, and we evaluate supplier quality and concentration risks as part of supply chain management.

Government Regulation

Our TriLink and Cygnus segments produce materials used in research and biopharmaceutical production, clinical trial vaccines and vaccine support products. We produce materials in support of our customers’ manufacturing businesses and to fulfill their validation requirements, as applicable. These customer activities are subject to extensive regulation by FDA and other national regulatory agencies and consequently require these businesses to be inspected by such agencies under their respective cGMP regulations. As a result, our customers impose rigorous quality requirements on us for the manufacture of our products, and maintain records of our manufacturing, testing and control activities. In addition, the specific activities of some of our businesses require us to hold specialized licenses for the manufacture, distribution and/or marketing of particular products.

All of our sites are subject to licensing and regulation, as appropriate under federal, state and local laws relating to:

•the surface and air transportation of chemicals, biological reagents and hazardous materials;

•the handling, use, storage and disposal of chemicals (including toxic substances), biological reagents and hazardous waste;

•the procurement, handling, use, storage and disposal of biological products for research purposes;

•the safety and health of employees and visitors to our facilities; and

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•protection of the environment and general public.

Regulatory compliance programs at each of our businesses are managed by a dedicated group responsible for regulatory affairs and compliance. Our compliance programs are also managed by quality management systems, such as vendor supplier programs and training programs. Within each business, we have established Quality Management Systems (“QMS”) responsible for risk based internal audit programs to manage regulatory requirements and client quality expectations. Our QMS program ensures that management has proper oversight of regulatory compliance and quality assurance, inclusive of reviews of our system practices to ensure that appropriate quality controls are in place and that a robust audit strategy confirms requirements for compliance and quality assurance.

Research Products

Our products and operations may be subject to extensive and rigorous regulation by the FDA and other federal, state, or local authorities, as well as foreign regulatory authorities. The FDA regulates, among other things, the research, development, testing, manufacturing, clearance, approval, labeling, storage, recordkeeping, advertising, promotion, marketing, distribution, post-market monitoring and reporting, and import and export of pharmaceutical drugs. Certain of our products are currently marketed as RUO.

We believe that our products that are marketed as RUO products are exempt from compliance with GMP regulations under the Food, Drug, and Cosmetic Act (“FDCA”). RUO products cannot make any claims related to safety, effectiveness or diagnostic utility and they cannot be intended for human clinical diagnostic use. In November 2013, the FDA issued a final guidance on products labeled RUO, which, among other things, reaffirmed that a company may not make any clinical or diagnostic claims about an RUO product. The FDA will also evaluate the totality of the circumstances to determine if the product is intended for diagnostic purposes. We do not make claims related to safety or effectiveness of our RUO products and they are not intended for diagnostic or clinical use, however, if the FDA were to determine, based on the totality of circumstances, that our products labeled and marketed for RUO are intended for diagnostic purposes, they would be considered medical products that will require clearance or approval prior to commercialization.

Active Pharmaceutical Ingredients (“APIs”) for Clinical Trials

We provide APIs to customers for use in preclinical studies through and including clinical trials. We hold a drug manufacturing license with the California Food and Drug Branch of the California Department of Public Health for manufacture of APIs for clinical use and are subject to inspection to maintain licensure. Manufacture of APIs for use in clinical trials is regulated under § 501(a)(2)(B) of the FDCA, but is not subject to the current GMP regulations in 21 CFR § 211 by operation of 21 CFR § 210. We follow the principles detailed in the International Council for Harmonisation (“ICH”) Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Section 19, APIs For Use in Clinical Trials) in order to comply with the applicable requirements of the FDCA, and the comparable GMP principles for Europe; European Community, Part II, Basic Requirements for Active Substances Used as Starting Materials (Section 19, APIs For Use in Clinical Trials). APIs are provided to customers under customer contracts that outline quality standards and product specifications. As products advance through the clinical phases, requirements become more stringent, and we work with customers to define and agree on requirements and risks associated with their product.

Customers’ biopharmaceutical products early in their development have a high failure rate and often do not advance through the clinical stages to commercialization. Our customers are required to follow regulatory pathways that are not always known, which may cause additional unforeseen requirements placed on us as their contract manufacturer and delays in advancing to the next stage of product development. We also provide novel compounds for cell and gene therapy applications, which result in additional challenges for our customers attempting to obtain regulatory approval given that this field is relatively new, and regulations are evolving. Customer clinical trials rely on approval from institutional review boards (“IRBs”) and patient and volunteer enrollment, which makes timelines unpredictable for advancing to the next stage in product development. Preclinical studies and clinical trials conducted by our customers are also expensive, and data may be negative or inconclusive causing customers to abandon projects that were expected to continue. Regulatory requirements in both the United States and abroad are always evolving, and compliance with future laws may require significant investment to ensure compliance.

Other Regulatory Requirements

Environmental laws and regulations. We believe that our operations comply in all material respects with applicable laws and regulations concerning environmental protection. To date, there have been no material effects upon our earnings or competitive position resulting from our compliance with applicable laws or regulations enacted or adopted relating to the protection of the environment. Our capital and operating expenditures for pollution control in 2025 and 2024 were not material and are not expected to be material in 2026.

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Intellectual Property

Our success depends in part on our ability to obtain and maintain intellectual property protection for our products and services, defend and enforce our intellectual property rights, preserve the confidentiality of our trade secrets, and operate without infringing, misappropriating or otherwise violating valid and enforceable intellectual property rights of others. We seek to protect the investments made into the development of our products and services by relying on a combination of patents, trademarks, copyrights, trade secrets, including know-how, and license agreements. We also seek to protect our proprietary products and services, in part, by requiring our employees, consultants, contractors and other third parties to execute confidentiality agreements and invention assignment agreements.

Patents. Our intellectual property strategy is focused on protecting, through patents and other intellectual property rights, our core products and services, including CleanCap®, and related instrumentation and applications. In addition, we protect our ongoing research and development into critical reagents for cell and gene therapy through patents and other intellectual property rights. Our patent portfolio generally includes patents and patent applications relating to compositions and methods for the production of CleanCap®, oligonucleotides, nucleic acids, immunofluorescence assays, and mock viral particles. We may own provisional patent applications, and provisional patent applications are not eligible to become issued patents until, among other things, we file national stage patent applications either directly or via the PCT within 12 or 30 to 32 months, respectively. If we do not timely file any national stage patent applications, we may lose our priority date with respect to our provisional patent applications and any patent protection on the inventions disclosed in such provisional patent applications. We cannot predict whether any such patent applications will result in the issuance of patents that provide us with any competitive advantage.

Issued patents extend for varying periods depending on the date of filing of the patent application or the date of patent issuance and the legal term of patents in the countries in which they are obtained. Generally, utility patents issued for applications are granted a term of 20 years from the earliest effective filing date of a non-provisional patent application. Issued patents may be extended beyond the natural 20-year term for regulatory or administrative delay in accordance with provisions of applicable local law. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

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The following granted patents relate to our CleanCap® products and technology.

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The following patents relate to our MockV® related products and technology.

Trademarks. Our trademark portfolio is designed to protect the brands of our current and future products and includes U.S. trademark registrations for our company name, Maravai LifeSciences, subsidiary names Cygnus Technologies and TriLink BioTechnologies and various product names, such as CleanCap® and MockV®.

Trade Secrets. We also rely on trade secrets, including know-how, unpatented technology and other proprietary information, to strengthen our competitive position. We have determined that certain technologies, such as the production of antibodies for biologics safety testing, are better kept as trade secrets, rather than pursuing patent protection. To prevent disclosure of trade secrets to others, it is our policy to enter into nondisclosure, invention assignment and confidentiality agreements with parties who have access to trade secrets, such as our employees, collaborators, outside scientific collaborators, consultants, advisors and other third parties. These agreements also provide that all inventions resulting from work performed for us or relating to our business and conceived or completed during the period of employment or assignment, as applicable, are our exclusive property. In addition, we take other appropriate precautions, such as physical and technological security measures, to guard against misappropriation of our proprietary information by third parties.

We intend to pursue additional intellectual property protection to the extent we believe it would advance our business objectives. Notwithstanding these efforts, there can be no assurance that we will adequately protect our intellectual property or provide any competitive advantage. We cannot provide any assurance that any patents will be issued from our pending or any future patent applications or that any issued patents will adequately protect our products or technology. Our intellectual property rights may be invalidated, held unenforceable, circumvented, narrowed or challenged. In addition, the laws of various foreign countries where our products are distributed may not protect our intellectual property rights to the same extent as laws in the United States. Furthermore, it may be difficult to protect our trade secrets. While we have confidence in the measures we take to protect and preserve our trade secrets, they may be inadequate and can be breached, and we may not have adequate remedies for violations of such measures. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. Moreover, our invention assignment agreements with employees, collaborators, outside scientific collaborators, consultants, advisors and other third parties may not be self-executing or otherwise provide meaningful protection for our intellectual property rights. If we do not adequately protect our intellectual property, third parties, including our competitors, may be able to use our technologies to produce and market products that compete with us and erode our competitive advantage. For more information regarding risks related to intellectual property, please see Item 1A. “Risk Factors—Risks Related to our Intellectual Property.”

Human Capital Management: Empowering Our Future

Our people are integral to driving Maravai's innovation, growth, and market leadership.

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As of December 31, 2025, we had 435 full-time employees globally. We aim to attract and retain talent through competitive compensation and benefits, including broad-based equity participation, training and development programs, and workplace health and safety initiatives.

Available Information

Our website is located at www.maravai.com, and our investor relations website is located at investors.maravai.com. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and any amendments to these reports, are available through our investor relations website, free of charge, as soon as reasonably practicable after we electronically file or furnish them with the SEC. Our filings with the SEC are also available, free of charge, on the SEC's website at www.sec.gov. We webcast via our investor relations website our earnings calls and certain events we participate in or host with members of the investment community. Our investor relations website also provides notifications of news or announcements regarding our financial performance and other items that may be material or of interest to our investors, including SEC filings, investor events, press and earnings releases. The contents of our website are not incorporated by reference into this Annual Report on Form 10-K or in any other report or document we file with the SEC, and any references to our website are intended to be inactive textual references only.