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Item 1. Business

2026-02-26 compared with 2025-03-18 · 83 added, 268 removed, 177 unchanged (66% of the section changed)

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Maravai LifeSciences Holdings, Inc.

(also referred to in this document as “Maravai,” “we,” “us,” “our” or “the Company”) is a leading life sciences company dedicated to providing critical products that drive the development of groundbreaking vaccines, drug therapies, cell and gene therapies, and diagnostics.

Our solutions empower research into human diseases and support the entire biopharmaceutical development process – from early discovery to commercialization.

We proudly serve a diverse global customer base, including the world’s top biopharmaceutical companies ranked by research and development investment, emerging biotech firms, renowned academic research institutions and leading in vitro diagnostics companies.

(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 vaccine, therapeutic and diagnostic applications;

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

• custom enzymes for research and diagnostic use;

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

At Maravai, we are committed to supporting our customers throughout their journey – from early discovery to commercialization – helping bring life-changing innovations to patients worldwide.

Our Strategic Priorities for Sustainable Growth:

1) Catalyze the Customer Journey.

We deliver solutions from across our portfolio that help to accelerate discoveries and create exceptional customer experiences.

2) Find a Better Way.

We constantly seek smarter, more efficient ways to enhance our processes, systems, and operations.

3) Deliver Unquestionable Quality.

Every action we take reflects our commitment to excellence, knowing that our products and services ultimately impact human lives – because behind every innovation, there’s a patient waiting.

4) Lead Together.

We harness the power of diverse perspectives and experiences to drive forward-thinking innovations together.

At Maravai, our goal is to achieve diversified, sustainable growth across our businesses by providing essential products and services that fuel the advancement of next-generation medicines from discovery to the clinic.

Business Segments and Products

We report our business in two reporting segments – Nucleic Acid Production and Biologics Safety Testing.

We market our Nucleic Acid Production business under the TriLink BioTechnologies®, Glen Research and Alphazyme brands.

Our Biologics Safety Testing business is comprised of Cygnus Technologies®.

Our brands, products and the end markets they serve are depicted in the following image:

Nucleic Acid Production (76% of Revenue for the Year Ended December 31, 2024)

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, long and short oligonucleotides, our proprietary CleanCap® mRNA capping technology, mRNA building blocks, oligonucleotide building blocks and specialty enzymes.

Our offerings address key customer needs for critical components, from research to good manufacturing processes (“GMP”) grade raw materials and active pharmaceutical ingredient (“API”) manufacturing.

The nucleic acid production market includes the production and synthesis of reagents for research and manufacturing of DNA and RNA-based biologics, including cell and gene therapies, mRNA therapeutics and synthetic biology approaches.

mRNA lies at the core of our capabilities and expertise.

We have developed significant proficiency in mRNA technology, driven by our belief in its transformative potential as a therapeutic modality.

The first clinical trial involving an mRNA therapeutic agent took place in 2016.

Since then, over 1,500 clinical trials are now in the pipeline, encompassing a wide range of medical applications.

These trials include vaccine development programs targeting infectious diseases such as avian flu, Lyme disease, malaria, HIV, tuberculosis, shingles, rabies, yellow fever, respiratory syncytial virus (RSV), and Zika.

Beyond infectious diseases, mRNA-based programs are addressing various medical conditions, including ornithine transcarbamylase deficiency, glycogen storage disorders, alpha-1 antitrypsin deficiency, acute lymphoblastic leukemia, Hurler syndrome, ovarian cancer, cardiovascular disease, and autoimmune disorders.

Cell and gene therapy programs also leverage mRNA across multiple therapeutic modalities, such as CRISPR/Cas9, transcription activator-like effector nucleases (TALENs), enzyme replacement therapies, allogeneic CAR-T cells, and base editing.

These advancements underscore the broad and growing impact of mRNA technology in revolutionizing healthcare.

We offer the following nucleic acid products:

mRNA, RNA Capping (CleanCap), oligonucleotides, oligonucleotide synthesis inputs, nucleoside triphosphates, custom nucleic acid chemistry, and specialty enzymes.

We also offer Discovery/RUO and GMP mRNA synthesis through our manufacturing services.

mRNA is an intermediary molecule that translates the genetic information stored in DNA into proteins.

The genetic information stored in DNA is transferred to mRNA in a cellular process called transcription.

This process occurs in the nucleus of cells.

DNA, a double stranded molecule, is unwound and copied as mRNA by the enzyme RNA polymerase.

transferred out of the nucleus to the cytosol, a component of the cytoplasm of a cell, where it serves as a blueprint for making cellular proteins by a multi-component organelle complex called the ribosome.

mRNA has traditionally been a difficult molecule for vaccine and therapeutic purposes.

mRNA is inherently unstable compared to DNA and is susceptible to degradation by ubiquitous enzymes called RNases.

mRNAs are also physically and chemically fragile and can degrade at elevated temperatures and under shear forces that occur during downstream manufacturing processes.

We have developed manufacturing processes that overcome many of these obstacles, resulting in highly effective mRNA.

We develop and manufacture mRNA products to support vaccine and therapeutic programs from pre-clinical development through and including clinical phases, including scale-up and analytical development services.

The mRNA molecules may serve as APIs for diverse applications, such as enzyme replacement therapies, gene editing therapies and vaccines.

We offer both research grade material and material made under GMP conditions to support all phases of development.

Within the mRNA category, we also offer our patented CleanCap technology.

CleanCap analogs principally serve the mRNA vaccine and therapeutics markets.

Cap analogs are a component of mRNA that aids in protein production as well as in making mRNA more stable inside cells.

For mRNA to serve as a template to make a protein, it requires a special cap at the 5’ end of the molecule.

The cap structure also affects the stability of the mRNA.

Lack of a cap can result in activation of the innate immune system, which can affect the production of the desired protein or elicit undesired biological effects.

We offer a suite of CleanCap analogs that are specifically made for therapeutics and vaccines.

CleanCap analogs are sold as a stand-alone reagents or bundled with other raw materials such as Nucleoside triphosphates (“NTPs”) and enzymes to support the synthesis of mRNA .

Our cap analogs are a critical component of several mRNA vaccines and therapies in development.

Traditionally, the 5’ cap has been added in one of two ways.

The cap can be added post mRNA synthesis by an enzymatic process.

This enzymatic method has several drawbacks, including the high cost of the capping enzymes as well as the need to perform additional processing steps to the invitro-transcription (“IVT”) synthesis process to remove enzymes and byproducts of the capping reaction.

While capping efficiency is usually high, the extra processing steps typically result in degradation and mRNA of poorer quality.

The second method is to add a synthetic cap analog into the transcription reaction such that the mRNA is transcribed and capped in a single step.

Anti-reverse cap analog (“ARCA”) is an example of a cap analog that is added to the transcription reaction.

This avoids the workflow challenges of the enzymatic process, but typically results in lower yields.

Like ARCA, CleanCap analogs are synthetic, chemically-made mRNA 5’ cap analogs added to the transcription process in a single step.

Unlike ARCA, however, CleanCap results in significantly higher levels of capping efficiency, resulting in very low levels of uncapped mRNA, which in turn minimizes the risk of activation of the innate immune system.

In addition, CleanCap’s higher mRNA yields compared to ARCA result in lower cost of goods.

When compared to enzymatic capping, CleanCap removes the additional downstream purification steps required.

We currently offer several variations of the CleanCap molecule, serving the needs of mRNA and self-amplifying RNA developers.

CleanCap is available in two quality grades, research use only for discovery and development activities, and a GMP-grade for clinical and commercial applications.

Our newest CleanCap analog, CleanCap M6, was introduced in May 2023 and is our most robust cap analog to date, enabling mRNA that delivers higher levels of protein production.

CleanCap mRNA products represented 72% of our Nucleic Acid Production revenue for the year ended December 31, 2024 (including the revenue from CleanCap products).

We estimate that revenue from high-volume sales of CleanCap for

commercial phase vaccine programs represented approximately 25.4% and 21.0% of our total revenues for the years ended December 31, 2024 and 2023, respectively.

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.

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.

Oligonucleotides.

The oligonucleotide product category supports broad customer applications, including therapeutics, in vitro diagnostics, NGS and CRISPR-based gene editing.

Most of our TriLink BioTechnologies 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.

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 through Glen Research include reagents and support supplies for DNA and RNA oligonucleotide synthesis, labeling, modification and purification.

We are a reputable and trusted vendor with a large portfolio, quality brand, knowledgeable technical support, and responsive customer service.

In addition to oligonucleotide synthesis service providers, our customer base includes life science, biopharma and diagnostic companies, academic institutions and government organizations, all of which internally manufacture their own oligonucleotide products.

Nucleoside Triphosphates.

Nucleoside triphosphates (“NTPs”) are the precursors to DNA and RNA.

They are composed of a nitrogen base bound to either ribose or deoxyribose with three phosphate groups added to the sugar.

We manufacture NTPs that are used in polymerase chain reactions, in sequencing reactions and in the manufacture of mRNA.

The NTPs can be unmodified, composed of the four standard bases, or modified, with a base altered to enhance a particular biological property, such as the ability to evade the innate immune system in therapeutic applications.

TriLink BioTechnologies NTPs are used by customers in both research and clinical trial applications.

Our manufacturing capabilities for NTPs now includes both RUO and GMP-grade.

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 .

TriLink BioTechnologies has synthetic chemistry expertise and proprietary manufacturing processes allowing for the highest purity NTP, amidite and custom nucleotide services.

We serve a diverse market of diagnostics and therapeutic developers that require novel molecules that are otherwise unavailable on the market.

Typically, these molecules are initially manufactured in small quantities, and then scaled to meet the need of larger diagnostic platforms or therapeutic applications once positive candidates have been identified by the customer.

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 critical to almost every phase of nucleic acid production and provide the key starting materials for the IVT process to make mRNA.

Alphazyme provides custom, scalable molecular biology enzymes with a full product line of IVT, NGS, life science and diagnostic enzyme solutions.

Alphazyme enzymes are also incorporated into the TriLink Biotechnologies CleanScript mRNA production workflow.

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.

Through TriLink BioTechnologies, we offer a core set of products and services geared toward customers doing early-stage development work.

We produce mRNA utilizing standard sequences for generalized research or using customer supplied sequences for custom built constructs.

We also provide process development services to optimize customers’ transcription and purification processes.

These services can integrate with our cap analogs, NTP products and IVT enzymes and have access to our analytical and QC method development.

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.

Our TriLink BioTechnologies GMP mRNA manufacturing services offer a clear pathway for customers running clinical trials.

We focus on building partnerships with our customers in the emerging market of cell and gene therapy to ensure we are well-positioned to be an extension of their development teams.

Our services feature robust quality management systems and include process development and scale-up, phase-appropriate, regulatory submission support, and in-house analytical services for mRNA analysis and characterization.

Biologics Safety Testing (24% of Revenue for the Year Ended December 31, 2024)

For over 25 years, the Cygnus Technologies brand has been associated with products and services that enable the detection of impurities present in bioproduction.

Our biologics safety testing products are used during development and scale-up, during the regulatory approval process and throughout commercialization.

We are recognized globally for the detection of host cell proteins (“HCPs”) and process-related impurities during bioproduction.

Our customers in this segment manufacture a broad range of biopharmaceutical products.

These include monoclonal antibodies and recombinant proteins, both as novel biologics and biosimilars, and recombinant vaccines, including oncolytic vaccines to treat cancer.

We also provide products that support the development and commercialization of cell and gene therapies.

Recombinant vaccines and cell and gene therapies rely on manufacturing of various viral vectors produced using recombinant nucleic acid and cell culture technologies.

Viral vector manufacturing processes require rigorous analytics, including testing for process-related impurities such as HCPs, host cell DNA, purification leachates, growth media additives and enzymes used in viral vector purification processes.

Of all process-related impurities, HCPs present the most complex impurity.

Per regulatory requirements, viral vectors used as a component of CAR-T cell therapies or as gene therapies must be produced in certain cell lines, purified and tested for the presence of host cell proteins.

All of the 24 existing FDA-and EMA-approved CAR-T Cell and Gene Therapies use Cygnus Host Cell Protein enzyme-linked immunosorbent assay (“ELISA”) kits for HCP testing for commercial product lot release.

Five of these 24 therapies were approved in 2024.

ELISA is the benchmark method for monitoring levels of process-related impurities during the purification process and in product release testing.

The advantages of well-developed ELISA kits include the ability to measure very low levels of impurities in the presence of high amounts of drug product, and are readily transferable across an organization from process development to manufacturing and quality control bioanalytical groups.

Though relatively simple to run, these ELISA kits require a high level of expertise to design, develop and qualify.

Customers establishing biopharmaceutical manufacturing processes may use off-the-shelf or generic HCP kits provided by manufacturers like ourselves, or they may choose to design their own in-house assays for their specific processes.

Some customers may choose to use generic assays early in development and migrate to process-specific assays later.

The trend in recent years has been for customers to increasingly use generic assays throughout their development and commercialization pathway, relying on our expertise and the established performance of our assays supported by our comprehensive state-of-the-art assay qualification services.

If customers choose to develop process-specific assays, we offer custom antibody production and assay development as well as characterization services to meet their needs.

Our comprehensive catalog of Cygnus Technologies HCP ELISA kits covers 25 expression platforms and provides the specificity and sensitivity to detect impurities with reproducibility, which supports regulatory compliance.

Our reputation for quality is recognized by the industry and global regulatory agencies, with Cygnus Technologies assays used as reference methods throughout the industry and to support manufacturing and quality control of commercialized biologics and gene therapy products.

Our customers in this segment are biopharmaceutical companies, contract research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”) and life science companies.

Cygnus Technologies product categories include HCP ELISA kits, other bioprocess impurity and contaminant ELISA kits, viral clearance prediction kits, ancillary reagents and custom services.

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 the expression system used in bioproduction.

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.

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Other Impurity and Contaminant Kits .

Our products in this category include kits for measuring Protein A leachate, which results from the affinity purification method used for monoclonal antibody therapeutic agents;

ELISA kits for measuring additives in growth media, such as bovine serum albumin;

kits for measuring host cell DNA;

ELISA kits to detect and quantify residual endonuclease impurities in recombinant viral vector and vaccine preparations;

and ELISA kits to quantify residual AAV2, AAV8 and AAV9 ligands resulting from affinity purification method used for adeno associated virus (AAV)-based gene therapies.

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 .

Following its 2020 acquisition of the MockV® technology, Cygnus Technologies has introduced the Minute Virus of Mice kit and the MockV RVLP Kit, which are novel, proprietary viral clearance prediction tools that includes 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 easily and economically and to predict outcomes in-house ahead of costly and logistically challenging live viral clearance studies.

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 .

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Custom Services .

We provide process-specific antibody and ELISA development, qualification and maintenance services.

In addition, we have pioneered advanced orthogonal methods including antibody affinity extraction (AAE™), mass spectrometry for HCP antibodies coverage analysis and HCP identification, which we provide as custom services.

Our Competitive Strengths

We believe we are a leader in providing nucleic acid products and services and biologics safety testing products and services to biopharmaceutical customers worldwide.

Our success is built on the ability of our proprietary technologies and products, provided under exacting quality standards, to reliably serve our customers’ needs for critical raw materials, and the process innovation, quality, analytical expertise and reliability of our services.

Leading Supplier of Critical Solutions for Life Sciences from Discovery to Commercialization

We seek to be an important component of our customers’ supply chain by providing inputs that are central to the performance of their products and processes throughout the product lifecycle.

By collaborating with customers early in the development phase, our products frequently follow our customers’ development path to commercialization and are likely to be incorporated as raw materials in their on-market products and processes.

Our decades-long experience and track record, coupled with our ongoing investment in facilities and quality systems, allow our customers to rely on us for their critical products.

Our approach is to be a trusted partner throughout the life cycle of our customers’ products.

Innovation, Proprietary Technologies and Expertise Underpin Our Portfolio

Our expertise in complex chemistries leads customers to seek our collaboration in designing complex products that meet high performance expectations.

We believe the solutions we provide, in many cases, cannot be provided effectively by our competitors.

In certain cases, like our CleanCap technology, our know-how features differentiated performance characteristics and is backed by intellectual property.

In other cases, such as our HCP products, our antibodies are proprietary and therefore can only be supplied by us.

We believe the proprietary nature of our expertise and products solidifies our long-term customer relationships.

Products with Outstanding Quality Performance

We believe our products stand out when compared to those of our competitors because they present innovative solutions to customer needs, while providing reliable performance and quality.

CleanCap, for example, offers advantages over competing capping technologies in yield, process efficiency, stability and safety.

Our oligonucleotides address complex chemistry challenges, which we believe few competitors can address.

We believe that our HCP ELISA kits have defined the market for impurity detection and have become a de facto standard in biologics safety testing.

Trusted Brands

Our TriLink BioTechnologies, Glen Research, Alphazyme and Cygnus Technologies brands are well known in their respective markets for innovation, consistent quality, and performance.

This brand recognition has been earned over decades.

Our manufacturing processes, quality standards, technical support and high-touch customer service ensure that we maintain the reputation of our brands.

State-of-the-Art Manufacturing Facilities

Our biopharmaceutical customers manufacture their products to meet stringent quality standards under strict regulatory guidelines and expect their critical suppliers to meet their exacting requirements.

Our customers further expect that we have the production capacity to meet their needs in a timely manner.

We have designed and constructed four world-class manufacturing facilities and, since 2022, we have expanded our facility footprint by over 95,000 square feet to support expanded capabilities and future growth.

Experienced Leaders and Talented Workforce

Our management includes experienced leaders with demonstrated records of success at Maravai and other highly regarded industry participants.

They have decades of combined experience and expertise on the forefront of life sciences innovation.

In addition, as of December 31, 2024, approximately 28% of our workforce have earned advanced degrees and all receive rigorous on the job training.

We believe the quality of our personnel is critical to ensuring the collaborative, long-standing relationships we maintain with many of our customers.

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.

We have relationships with the following categories of customers:

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Our biopharmaceutical customers include startups, established biotechnology companies and large pharmaceutical companies developing enzyme replacement therapies, gene editing therapies, ex vivo therapies and vaccines.

Our commercial function includes direct sales, marketing, customer service, technical support, quoting and proposals, client program management and channel management.

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 web, 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 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 distributors.

We serve many of our biopharmaceutical customers, especially in our nucleic acid production segment, via direct sales worldwide.

Our distributors also serve our customers in over 40 countries and provide customer service and local sales and marketing.

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.

We compete with a range of companies across our segments.

Nucleic Acid Production

Within nucleic acid production, we compete with four primary types of companies:

(1) chemistry companies that create and produce the basic monomers, amidites, and supports that go into the creation of an oligonucleotide;

(2) oligonucleotide manufacturers that specialize in custom oligonucleotide development of varying complexities and scales;

(3) mRNA biotechnology companies that create fully processed mRNA and specialize in custom, complex orders;

and (4) CDMOs that have the capability to accept work from large biopharmaceutical companies and serve as the outsourcing entity for the development and manufacturing of nucleic acid products.

However, it is important to note that CDMOs seldom offer proprietary products.

For mRNA capping analogs, we compete principally with Thermo Fisher Scientific, Aldevron (a subsidiary of Danaher), and New England Biolabs, who offer alternatives to CleanCap with enzymatic capping solutions.

Many biopharmaceutical companies produce capping solutions in-house using enzymatic or ARCA processes.

However, given CleanCap’s high yield and process efficiency, many customers who previously insourced these processes have begun to partner with us.

We believe our products and services are more effective than those of our competitors.

Deep scientific expertise, intellectual property protection and specialty equipment serve as barriers to entry in this space.

For our mRNA offerings, we compete with Aldevron, Patheon, eTheRNA, Lonza, Catalent, and Samsung Biologics, among others.

We believe we have a reputation for our expertise in the RNA space with talented scientists who are constantly pushing the frontier of RNA science.

This scientific expertise and the required high-cost equipment serve as barriers to entry.

In addition to our expertise, we believe our GMP cleanroom manufacturing process differentiates us from competitors.

For custom oligonucleotides, we compete with a number of manufacturers.

Custom oligonucleotide providers include those that provide complex, highly modified oligonucleotides and those that provide less complex offerings.

In the custom oligonucleotide space, complexity is based on the length of the sequence and level of modification to the phosphate backbone.

Large manufacturers like Integrated DNA Technologies, Thermo Fisher Scientific and EMD Millipore Corporation (“Millipore Sigma”) serve less complex customer needs while we, LGC Biosearch Technologies and GenScript Biotech Corporation serve more complex customer needs.

In the custom oligonucleotide market, we have a reputation for accepting complex orders and delivering high purity products that reduce researcher re-work and save money.

Quick turnaround times and the ability to produce at scale are essential requirements in this segment.

In the oligonucleotide synthesis inputs market, we compete against large distributor-manufacturers like Thermo Fisher and Millipore Sigma while also serving them as customers.

Our Glen Research brand has a long history in this industry, which drives customer loyalty, and has a reputation for high-fidelity technical service, focusing on supplying and sourcing highly modified inputs for its customers.

For our specialty enzymes offering, we compete with New England Biolabs, Thermo Fisher, QIAGEN, and Roche, among others.

We believe that Alphazyme is uniquely positioned in the market to address customers’ custom enzyme needs and has a reputation of being a flexible partner.

Biologics Safety Testing

For drugs in early development, we compete against other bioprocess impurity kit providers such as BioGenes (“BioGenes”) or Enzo Life Sciences (“Enzo”).

Competitors generally offer fewer expression platforms (generally between one and three) compared to our offering of 24 expression platforms and over 100 different impurity detection kits.

As a drug successfully moves forward to validation and approval stages, a customer may either continue with an off-the-shelf kit or they may begin the process to develop a custom assay that is tailored to meet their specific host cell and manufacturing process needs.

During the entire drug development process, and especially during this decision, we are partners with the manufacturer and provide our expertise to help them make the best bioprocess quality control and testing-related decisions.

If a drug manufacturer continues with an off-the-shelf assay from development to validation and approval, they will generally stay with the incumbent kit provider due to the extensive validation they have conducted.

For custom assay development, our main competitors are BioGenes, Rockland Immunochemicals and some CDMOs and CROs with custom assay development capabilities.

The trend in recent years has been for CDMOs, CROs and large biopharmaceutical companies to focus on core competencies and outsource host cell protein assays or qualify off-the-shelf kits when possible.

Licenses and Collaborations

Broad Patent License Agreement

We (through TriLink BioTechnologies) entered into a Nonexclusive Patent License and Material Transfer Agreement with The Broad Institute, Inc.

(“Broad”) effective as of July 5, 2017, and amended on September 29, 2017 (the “Broad Patent License Agreement”).

Broad, together with a consortium of educational institutions (including Harvard University and the Massachusetts Institute of Technology), owns and controls certain patent rights relating to genome editing technology, including the CRISPR-Cas9 gene editing processes and have a licensing program for use and commercialization of technologies and products covered by the underlying patent rights.

Under the Broad Patent License Agreement, Broad grants to us a non-exclusive, royalty-bearing, non-transferable and non-sublicensable, worldwide license under the licensed patent rights to manufacture and sell products and to perform certain in vitro processes or services on a fee-for-service basis, in each case, solely as research tools for research purposes (excluding human, clinical or diagnostic uses).

We must use diligent efforts to develop products, introduce products into the commercial market and make products reasonably available to the public.

We are obligated to pay a mid-five figure annual license maintenance fee and royalties in the range of 5% to 10% on net sales of covered products and processes.

The term of the Broad Patent License Agreement extends through the expiration of the last to expire claim of any of the licensed patents.

We are entitled to terminate the Broad Patent License Agreement for convenience at any time on at least three (3) months written notice, in which case we must continue to pay license maintenance fees and royalties as noted above for the sale of products that are not covered by the specific claims of the licensed patent rights but are otherwise derived from such licensed patent rights or from products covered by such licensed patent rights.

Broad may terminate the license for our uncured failure to make payments, for our uncured material breach or if we bring a patent challenge against any of the institutional rights holders.

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.

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.

Our Wateridge facility in San Diego is engaged in the manufacture of reagents.

The facility was designed and built by us in conjunction with the building owner to contain fully functional chemical and biological manufacturing operations from material receiving to product distribution and has its own loading dock, manufacturing gas delivery system, solvent delivery and waste system, ISO Class 8 and ISO Class 7 designated customer manufacturing suites and integrated building management systems for required site control.

In addition to the Wateridge facility, we have two other facilities in San Diego, Flanders 1 and Flanders 2.

Flanders 1 provides us with additional GMP manufacturing capacity and the optionality downstream to manufacture materials beyond current quality requirements for mRNA raw materials, including CleanCap.

Flanders 1 supports increased batch run sizes and overall throughput.

Flanders 2 was purpose built to support GMP-grade manufacturing and to support customers into Phase II clinical trials through commercial mRNA drug substance.

Both the Flanders 1 and Flanders 2 facilities include integrated manufacturing systems, quality water improvements from Reverse Osmosis De-ionized grade water to WFI (“Water For Injection”), which is pharmaceutical grade water, and other facility infrastructure investments to support potential customer needs related to quality.

We took occupancy of the Flanders 1 and 2 facilities in 2023 and began manufacturing from both locations in 2024.

Our Leland, North Carolina facility is engaged in the development, manufacture and processing of antibodies and HCP and Impurity ELISA kits, MockV Kits, as well as execution of all analytical services.

The operations include R&D, laboratory, manufacturing, kitting, cold storage, shipping and waste handling capabilities.

The fully customized design includes a Mass Spectrometry Center of Excellence and specialized cell culture facilities.

Extensive process flow analysis has been incorporated into the facility design to optimize and enhance both our manufacturing and kit packaging operations.

Our Sterling, Virginia facility was designed to perform quality control, aliquoting, packaging and shipping and houses the appropriate space and systems.

Our Jupiter, Florida, location is a purpose built enzyme production facility that can produce enzymes to kilogram quantities.

The facility includes environmental controls such as HEPA filtration, pressure, temperature, and humidity monitoring, with vertical integration of all enzyme development, production, and testing operations.

Our enzymes are produced under the controls of an ISO 13485:2016 compliant QMS.

Our supply chain is supported by a diverse network of specialized suppliers and transportation partners and undergoes regular evaluations to assess supplier quality and identify risks, including those associated with supply concentration.

These proactive evaluations enable us to implement strategic measures to effectively manage and mitigate risks.

By continuously optimizing our supply chain, we ensure operational resilience and maintain a steady supply of critical materials for our products.

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

We provide products used for basic research or as raw materials used by biopharmaceutical customers for further processing, and active pharmaceutical ingredients used for preclinical and clinical studies.

The quality of our products is critical to researchers looking to develop novel vaccines and therapies and for biopharmaceutical customers who use our products as raw materials or who are engaged in preclinical studies and clinical trials.

Biopharmaceutical customers are subject to extensive regulations by the FDA and similar regulatory authorities in other countries for conducting clinical trials and commercializing products for therapeutic, vaccine or diagnostic use.

This regulatory scrutiny results in our customers imposing rigorous quality requirements on us as their supplier through supplier qualification processes and customer contracts.

Our nucleic acid and biologics safety testing segments produce materials used in research and biopharmaceutical production, clinical trial vaccines and vaccine support products.

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 regulation and consequently require these businesses to be inspected by the FDA and other national regulatory agencies under their respective cGMP regulations.

These regulations result in our customers imposing quality requirements on us for the manufacture of our products, and maintain records of our manufacturing, testing and control activities.

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.

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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, including the use of outside consultants.

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.

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.

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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 research use only (“RUO”).

We believe that our products that are marketed as RUO products are exempt from compliance with GMP regulations under the FDCA.

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.

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The FDA will also evaluate the totality of the circumstances to determine if the product is intended for diagnostic purposes.

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.

We do not make claims related to safety or effectiveness and they are not intended for diagnostic or clinical use.

However, the quality of our products is critical to meeting customer needs, and we therefore voluntarily follow the quality standards outlined by the International Organization for Standardization for quality management systems (ISO 9001:2015) for the design, development, manufacture, and distribution of our products.

Some biopharmaceutical customers desire extra requirements including quality parameters and product specifications, which are outlined in customer-specific quality agreements.

These products are further processed and validated by customers for their applications.

Customers qualify us as part of their quality system requirements, which can include a supplier questionnaire and on-site audits.

Customers requalify us on a regular basis to ensure our quality system, processes and facilities continue to meet their needs and we are meeting requirements outlined in relevant customer agreements.

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

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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

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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