What changed in this filing

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Item 1. Business

2022-03-01 compared with 2021-03-22 · 169 added, 339 removed, 391 unchanged (57% of the section changed)

Maravai LifeSciences Holdings, Inc.

(also referred to in this document as “Maravai”, “Pubco”, “we”, “us” or “the Company”) is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, novel vaccines and support research on human diseases.

Our more than 5,200 customers as of December 31, 2020 include the top 20 global biopharmaceutical companies ranked by research and development expenditures according to industry consultants, and many other emerging biopharmaceutical and life sciences research companies, as well as leading academic research institutions and in vitro diagnostics companies.

Our products address the key phases of biopharmaceutical development and include complex nucleic acids for diagnostic and therapeutic applications, antibody-based products to detect impurities during the production of biopharmaceutical products, and products to detect the expression of proteins in tissues of various species.

Our businesses principally address high growth market segments in biopharmaceutical development that are growing at a weighted average blended rate of 20% per annum.

(also referred to in this document as “Maravai”, “we”, “us” or “the Company”) is a leading life sciences company providing critical products to enable the development of drug therapies, diagnostics, and novel vaccines and to support research on human diseases.

Our customers include the top global biopharmaceutical companies ranked by research and development expenditures according to industry consultants, and many other emerging biopharmaceutical and life sciences research companies, as well as leading academic research institutions and in vitro diagnostics companies.

Our products address the key phases of biopharmaceutical development spanning research to commercialization and include complex nucleic acids for diagnostic and therapeutic applications, and antibody-based products to detect impurities during the production of biopharmaceutical products.

Our businesses principally address high growth market segments in biopharmaceutical development.

In particular, the field of cell and gene therapy has emerged as one of the fastest growing treatment modalities to address a host of human conditions.

There are more than 400 cell and gene therapies in development or launched and sales in this category are expected to grow more than tenfold by 2024, according to industry consultants and management estimates.

There are more than 1,600 cell and gene therapies in development or launched and sales in this category are expected to grow more than 5 times by 2024, according to industry consultants and management estimates.

Our portfolio offers key products for each stage of the cell and gene therapy development lifecycle.

For example, our mRNA products are used in drug development to assist in the production of immune-activating antigens;

For example, our messenger RNA (“mRNA”) products are used in drug development to assist in the production of immune-activating antigens;

our CleanCap ® technology is used to stabilize mRNA and streamlines mRNA manufacturing;

and our plasmid DNA products are used as templates for the production of our RNA products.

and our plasmid DNA products are used as templates for the production of our ribonucleic acid (“RNA“) products.

We also provide biologics safety testing technology used to ensure the safety of the biological drug manufacturing process and drug products.

We have relationships with the following categories of customers (percentages represent the share of revenue in each category for the year ended December 31, 2020):

developers of therapeutics and vaccines (66%), other biopharmaceutical and life science research companies (27%), academic institutions (4%) and molecular diagnostic companies (3%).

Developers of therapeutics and vaccines, including cell and gene therapies, comprise about 85% of our customer base.

Our proprietary capabilities and products underpin the value we aim to provide to our customers.

Among other capabilities, we are experts in RNA and mRNA products, which are challenging and often unstable molecules requiring significant chemical modifications to ensure their stability and efficacy in our customers’ applications.

Notably, according to research commissioned by us consisting of over 70 interviews with our current and former customers, our competitors and industry experts focused across our three business segments (the “Industry Analysis”), we believe CleanCap® is viewed as a leading solution to incorporate the 5’ cap into mRNA.

Notably, according to research commissioned by us in November 2021 consisting of over 55 interviews with our current and former customers, our competitors and industry experts focused across our two ongoing business segments (the “Industry Analysis”), we believe CleanCap is viewed as a leading solution to incorporate the five prime (“5’”) cap into mRNA.

CleanCap is a novel chemical approach to produce the 5’ cap analog, which, in addition to making mRNA more stable, aids in protein production and helps prevent an unwanted immune response to the mRNA.

As of December 31, 2020, CleanCap® had been used by over 110 customers as a stand-alone reagent and had been incorporated into several development programs targeting immunization against the novel strain of coronavirus, SARS-CoV-2 (“COVID-19”).

We also work with over 400 customers who use our CleanCap® technology through our custom mRNA services and catalog mRNA in support of their research and pre-clinical work.

These programs included two commercial programs led by Pfizer in partnership with BioNTech and the other led by BioNTech in partnership with Fosun Pharma, one phase I clinical program led

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by Chulalongkorn University, one phase I/II clinical programs led by Imperial College London, and one phase III program led by CureVac, and three pre-clinical programs led by the University of Tokyo in partnership with Daiichi-Sankyo, eTheRNA Immunotherapies and Greenlight Biosciences.

Given the early stage of these three programs, there can be no assurance they will continue to use CleanCap® through commercialization.

We estimate our mRNA and CleanCap® products have also been incorporated in at least 40 therapeutic programs in development as of December 31, 2020.

CleanCap had been incorporated into several mRNA programs targeting immunization against the novel strain of coronavirus, SARS-CoV-2 (“COVID-19”).

These programs included two commercial programs led by Pfizer in partnership with BioNTech and one led by BioNTech in partnership with Fosun Pharma, one phase I clinical program led by Chulalongkorn University, one phase I/II clinical programs led by Imperial College London, one phase I/II clinical program led by the University of Tokyo in partnership with Daiichi-Sankyo, one phase III program led by CureVac, and two pre-clinical programs by eTheRNA Immunotherapies and Greenlight Biosciences.

Given the early stage of these last two programs, there

can be no assurance they will continue to use CleanCap through commercialization.

We believe our CleanCap products have also been incorporated into vaccine development programs for other infectious diseases, including Influenza.

In addition to vaccines for infectious disease, we estimate our mRNA and CleanCap products have also been incorporated in at least 59 therapeutic programs in development as of December 31, 2021.

These therapeutic programs address a number of disease states, including ornithine transcarbamylase deficiency, glycogen storage disorders, Alpha-1 antitrypsin deficiency, acute lymphoblastic leukemia, Hurler syndrome, ovarian cancer and cardiovascular disease.

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Should one or more of these programs proceed to commercialization, we believe we will continue to supply our customers and our products will likely be incorporated in customer regulatory filings.

Additionally, The FDA recently issued policies on February 22, 2021 to guide medical product developers concerning the development of products to address the future of variants of the SARS-CoV-2 virus specifically covering vaccines and therapeutics.

We believe this guidance may streamline the future development and approval of mRNA vaccines utilizing our products and that they would likely be incorporated into customer regulatory filings.

Additionally, the U.S.

Food and Drug Administration (“FDA”) issued policies on February 22, 2021 to guide medical product developers concerning the development of products to address the future of variants of the COVID-19 virus specifically covering vaccines and therapeutics.

We believe this guidance may streamline the future development and approval of mRNA vaccines utilizing our products and that they would likely be incorporated into customer regulatory filings as a result.

mRNA is at the core of our capabilities.

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The first clinical trial for an mRNA therapeutic agent occurred in 2016.

More than 30 clinical trials have occurred since then, principally focused on vaccines against viruses and cancer vaccines.

Now, more than 200 clinical trials are in the pipeline, principally focused on vaccines against viruses and cancer vaccines.

With the COVID-19 pandemic, mRNA has shown its potential for more rapid vaccine design and manufacture when compared to traditional techniques involving culturing inactivated virus to elicit an immune response.

According to the World Health Organization, there were 263 COVID-19 vaccine development programs as of March 9, 2021, with two candidates approved in the RNA class and some additional RNA lead candidates for approval with anticipated program data readouts, including results of preclinical studies and phase I/II and phase III clinical trials.

COVID-19 has helped highlight the potential advantage of mRNA as a treatment modality and directed significant resources to the developing base of knowledge about mRNA.

We believe this knowledge will be directed at future vaccine programs as well as therapeutic agents for a host of human diseases.

According to the World Health Organization, there were nearly 350 COVID-19 vaccine development programs as of December 2021, with two candidates approved in the RNA class and 23 additional RNA lead candidates for approval with anticipated program data readouts, including results of preclinical studies and phase I/II and phase III clinical trials.

COVID-19 has helped highlight the potential advantage of mRNA as a treatment modality and directed significant resources to the growing base of knowledge about mRNA.

This knowledge is now being directed at future vaccine programs including for influenza, Lyme disease, malaria, HIV, tuberculosis, shingles, rabies, yellow fever, respiratory syncytial virus (“RSV”) and Zika, as well as for therapeutic agents for a host of human diseases.

We are positioned to serve our biopharmaceutical customers in the fast-growing field of mRNA across a range of clinical programs for a variety of diseases.

For the year ended December 31, 2020, 47% of our revenue was derived from products that support mRNA research.

Forming long-term partnerships with our customers is core to our strategy.

We primarily serve our customers during the product development and process development phases.

During product development, we collaborate with our customers to develop and synthesize nucleic acids, which in some cases comprise the APIs of our customers’ products in development.

Today, we primarily serve our customers during the product development and process development phases.

During product development, we collaborate with our customers to develop and synthesize nucleic acids, which in some cases comprise the active pharmaceutical ingredient (“API”) of our customers’ products in development.

We also provide our customers a host of chemically complex and highly specialized raw materials.

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In addition, our analytical tools are used in the design and development of manufacturing processes and often will be used throughout the life cycle of our customers’ manufactured products.

As a result, our customer relationships may span many years.

Once our services or products are qualified by our customers, we are written into regulatory documents and standard operating procedures.

As a result, our customer relationships frequently span many years.

The nature of our products and their uses require that they be manufactured by highly trained personnel in state-of-the-art facilities following exacting procedures to ensure quality.

We manufacture our nucleic acid products at our San Diego, California facility, one of four facilities we occupy in the United States.

The facility was purpose-built to address our customers’ needs for critical raw materials manufactured under certain good manufacturing practices (“GMP”) conditions and APIs for investigational use.

As of December 31, 2021, approximately 19% of our workforce have earned advanced degrees and all receive rigorous training on our procedures.

We manufacture our nucleic acid products at our San Diego, California facility (“Wateridge facility”), one of our three facilities in the United States.

The Wateridge facility was purpose-built to address our customers’ needs for critical raw materials manufactured under certain good manufacturing practices (“GMP”) conditions and APIs for investigational use.

Our raw material products are manufactured following the voluntary quality standards of ISO 9001:2015.

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Our API products are manufactured following the voluntary quality standards of ISO 9001:2015, the International Council for Harmonisation’s GMP Guide, comparable GMP principles for the European Union and customer specific requirements.

We believe our products are exempt from compliance with the current GMP (“cGMP”) regulations of the Food and Drug Administration (“FDA”), as our products are further processed or incorporated into final drug products by our customers and we do not make claims related to their safety or effectiveness.

As of December 31, 2020, we have invested $75.0 million in our San Diego facility.

We believe our products are exempt from compliance with the current GMP (“cGMP”) regulations of the FDA, as our products are further processed or incorporated into final drug products by our customers and we do not make claims related to their safety or effectiveness.

As of December 31, 2021, we had

invested $81.6 million in our Wateridge facility.

Our other facilities are similarly designed for specific applications with quality systems to match our customers’ requirements.

All of our facilities meet applicable ISO standards.

In addition, as of December 31, 2020, approximately 20% of our workforce have earned advanced degrees and all receive rigorous training.

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We built our business through a combination of acquisitions and subsequent investments in our acquired companies to grow their commercial capabilities, upgrade and expand their research and production facilities, deploy stringent quality systems, integrate their back-office functions, and develop the personnel and management to fuel continued growth.

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We completed our first acquisition in April 2016.

The trailing twelve-month revenue of each of our acquired businesses at the time we acquired each of them totaled approximately $85.0 million.

Mergers, acquisitions and strategic partnerships that complement our capabilities in cell and gene therapy and biopharmaceutical production remain core to our strategy.

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We are therefore a critical part of our customers’ supply chain and they frequently seek to maintain their supply relationship with us for the life of their products or development programs.

Our products address our customers’ needs for nucleic acid production, biologics safety testing and protein detection, and our operations are aligned to these three segments.

* Our plasmid DNA products launched in Q1 2021

Our products address our customers’ needs for nucleic acid production and biologics safety testing, and our operations are aligned to these two segments.

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

Nucleic Acid Production (89% of Revenue for the Year Ended December 31, 2021)

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We market our nucleic acid products under the TriLink BioTechnologies® and Glen Research brands.

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The growth in our nucleic acid production business segment has been fueled by the significant growth in biological drugs in development, many of which are addressing cell and gene therapies, and by the rapid rise in mRNA vaccines.

mRNA as a treatment modality has been an area of acute interest for several years.

The global COVID-19 pandemic, however, has demonstrated its potential advantages in speed of development and manufacturing, as well as cost.

Of the estimated 263 COVID-19 vaccine development programs underway as of March 9, 2021, according to the World Health Organization, 34 are mRNA-based.

Five of the 34, including two commercial programs led by Pfizer in partnership with BioNTech and the other led by BioNTech in partnership with Fosun Pharma, one phase I clinical program led by Chulalongkorn University, one phase I/II clinical programs led by Imperial College London and , one phase III program led by CureVac use our CleanCap® products and up to three more in early stages of development, led by the University of Tokyo in partnership with Daiichi-Sankyo, eTheRNA Immunotherapies and Greenlight Biosciences, are currently using our CleanCap® products.

Given the early stage of these 3 programs, there can be no assurance they will continue to use CleanCap® through commercialization.

We further serve cell and gene therapies with our RNA and mRNA products and expect to supplement with our upcoming plasmid DNA capability.

In addition to the vaccine programs above, our products have been incorporated in over 40 therapeutic programs in development for CRISPR/Cas-9, CAR-T, base editing, vaccine and enzyme replacement therapies, among others with over 25 utilizing CleanCap® technology.

Our nucleic acid products fall into three categories:

mRNA, oligonucleotides and plasmid DNA.

The growth in our nucleic acid production business segment has been fueled by the significant growth in biological drugs in development, many of which are cell and gene therapies, and by the rapid rise in mRNA vaccines.

mRNA as a treatment modality has been an area of acute interest for many years.

The success of COVID-19 vaccines has helped highlight the potential advantage of mRNA as a treatment modality and significant investments have been made industry wide to developing future mRNA vaccines as well as for therapeutic agents for a host of human diseases.

We are positioned to serve our biopharmaceutical customers in the fast-growing field of mRNA across a range of clinical programs for a variety of diseases.

We further serve cell and gene therapies with our RNA and mRNA products and expect to supplement with our newly launched plasmid DNA capability.

In addition to the vaccine programs above, our products have been incorporated in at least 59 therapeutic development programs including programs focused on CRISPR/Cas-9, CAR-T, base editing, and enzyme replacement therapies, among others, with over 50 utilizing CleanCap technology.

Our nucleic acid products fall into four main categories:

mRNA, RNA Capping (CleanCap), oligonucleotides and plasmid DNA.

We began offering our plasmid DNA products in the first quarter of 2021.

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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 some of these obstacles, resulting in highly effective mRNA.

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.

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Our proprietary CleanCap analogs principally serve the mRNA vaccine and therapeutics markets, including vaccine candidates in development for immunizing against COVID-19.

Cap analogs are a component of mRNA that aids in protein production as well as 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’ (five prime) end of the molecule.

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.

The 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.

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.

Based on the Industry Analysis, we believe our cap analogs are critical features of several mRNA vaccines in development.

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

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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 mRNA to remove enzymes and byproducts of the capping reaction.

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

While capping efficiency is usually high, the extra processing steps typically result degredation 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.

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CleanCap is sold as a stand-alone reagent or bundled with other mRNA products.

More than 110 customers have purchased CleanCap® as a stand-alone reagent and more than 250 customers have purchased mRNA with CleanCap®.

mRNA products represented 90% of our nucleic acid production revenue for the year ended December 31, 2021 (including the revenue from CleanCap products).

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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 (“PCR”), sequencing reactions and in the manufacture of mRNA.

We manufacture NTPs that are used in polymerase chain reactions (“PCR”), 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.

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Our product offerings also include reagents that form the building blocks of oligonucleotides with our Glen Research products, including high quality specialty chemicals and amidites.

The oligonucleotide products category represented 35% of our nucleic acid production revenue for the year ended December 31, 2020.

In December of 2020, we completed the manufacturing verification of plasmid DNA within our newly released manufacturing suite inside our San Diego facility.

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For over 20 years, the Cygnus Technologies brand has been associated with products and services that enable the detection of impurities present in bioproduction.

Our biologics

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

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.

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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 23 expression platforms and provides the specificity and sensitivity to detect impurities with reproducibility, which supports regulatory compliance.

Our comprehensive catalog of Cygnus Technologies HCP ELISA kits cover 23 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.

Our customers in this segment are biopharmaceutical companies, contract research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”) and life science companies, which together accounted for 46% of our biologics safety testing revenue for the year ended December 31, 2020.

International distributors and United States-based resellers accounted for 53% of this revenue.

These customers largely serve the biopharmaceutical industry.

Academia, hospitals and government accounts contributed 1% of our biologics safety testing revenue in the year ended December 31, 2020.

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

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

HCP ELISA kits.

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HCPs are a critical quality attribute for biologics safety testing development and must be adequately removed during the downstream purification process.

HCP ELISA kits represented 63% of our Biologics Safety Testing revenue in the year ended December 31, 2020.

Other impurity and contaminant kits .

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

In addition, in 2020, Cygnus Technologies introduced the MockV ™ Minute Virus of Mice (MVM) kit, a novel, proprietary viral clearance prediction tool 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.

Viral Clearance Prediction kits .

In 2020, Cygnus Technologies introduced the MockV® Minute Virus of Mice (“MVM”) kit, a novel, proprietary viral clearance prediction tool 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.

The kit enables 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.

Other impurity and contaminant kits represented 19% of our biologics safety testing revenue for the year ended December 31, 2020 in the biologics safety testing segment.

Ancillary reagents .

These products include antibodies, antigens, sample diluents and other auxiliary products necessary to optimize applications for customer processes.

Ancillary reagents represented 11% of our biologics safety testing revenue for the year ended December 31, 2020.

Custom services .

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

Custom services represented 7% of our biologics safety testing revenue for the year ended December 31, 2020.

Protein Detection (2% of Revenue for the Year Ended December 31, 2021)

We believe that we are a leader in labeling and detection reagents for immunohistochemistry, immunofluorescence and glycobiology, principally in research settings, with Vector Laboratories, Inc.

(“Vector Laboratories”), the brand under which we market our protein detection products, having been cited over 350,000 times in scientific publications.

Our products are used to detect the expression of proteins in tissue, which may indicate an ongoing disease process, with the use of antibody-based detection systems.

We also manufacture lectins, proteins that preferentially bind to carbohydrates and which are used, for example, in the study of glycosylation, the process by which carbohydrates attach to proteins and lipids.

Glycosylation is critical in a range of biological processes, including cell-to-cell adhesion, the performance of glycoprotein-based drugs and cancer.

In addition, we manufacture bioconjugation reagents to allow rapid and quantifiable conjugation of all classes of biomolecules.

Our presence in protein detection dates to the founding of Vector Laboratories in 1976.

Under the Vector Laboratories brand, we provide reagents to researchers worldwide investigating biological processes and the nature of disease in tissue, including oncology research applications.

Our reagents span the immunohistochemistry and immunofluorescence workflows and include products for tissue preparation, tagging targets of interest via secondary antibodies, detection systems for visualizing proteins, enzyme substrates for chromogenic color development, secondary antibodies to amplify target signal, fluorescent dyes for use in live cell imaging, fluorophore-conjugated secondary antibodies and products for the identification and isolation of glycosylated targets.

Our expertise includes the development of a broad range of highly validated secondary antibodies, used for labeling targets of interest.

We produce over 20 proprietary antibodies constituting over 180 different SKUs in different formats and quantities.

We also offer a broad portfolio of over 5 distinct lectins making up nearly 140 Stock Keeping Units (“SKUs”) addressing a broad set of applications.

Our capabilities extend to assay development, protein purification and bioconjugation as well as development of critical related reagents such as mounting media and substrates.

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We principally serve academic researchers worldwide in our protein detection segment.

Our research customers generally rely on us to provide our catalog products in a timely fashion, often overnight, and to provide live technical support and responsive customer service.

All protein detection products sold directly to academic researchers carry the Vector Laboratories brand.

We also sell custom products to industry customers, whether as components to be integrated into their own products, or to be resold.

We serve these customers with catalog products directly via Web, email and phone ordering;

with custom or bulk products through direct sales;

and through distributors and resellers.

Direct catalog sales represented 24% of our protein detection revenue for the year ended December 31, 2020.

Bulk and custom products sold directly accounted for 31% of our protein detection revenue and resellers and distributors together accounted for 45% of our protein detection revenue during the same period.

The remaining 2% of revenue generated in the year ended December 31, 2021, was from the sale of products to detect the expression of proteins in tissues of various species by our Protein Detection segment.

In September 2021, we completed the divestiture of Vector Laboratories, our Protein Detection segment which is not considered to be a significant part of our portfolio or capabilities.

Our Competitive Strengths

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

Innovation, Proprietary Technologies and Know-how Underpin Our Portfolio

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.

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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 know-how and products solidifies our long-term customer relationships.

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 our competitors’ because they present innovative solutions to customer needs, as indicated by the responses to the Industry Analysis, while providing reliable performance and quality.

We believe our products stand out when compared to those of our competitors’ because they present innovative solutions to customer needs, as indicated by the responses to the Industry Analysis, while providing reliable performance and quality.

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

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Trusted Brands

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

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

This brand recognition has been earned over decades.

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

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 and expect their critical suppliers to meet their exacting requirements.

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.

As of December 31, 2020, we have invested approximately $75.0 million into our flagship San Diego facility and its five dedicated manufacturing suites to produce materials under GMP conditions, along with the required quality systems to meet requirements specified by our customers.

Additionally, this investment in our San Diego facility allows us to meet our customers demand for our nucleic acid products, including CleanCap ® .

As of December 31, 2021, we had invested approximately $81.6 million into our flagship Wateridge facility and its five dedicated manufacturing suites to produce materials under GMP conditions, along with the required quality systems to meet requirements specified by our customers.

Additionally, this investment in our Wateridge facility allows us to meet our customers demand for our nucleic acid products, including CleanCap.

We similarly invest in our other sites to ensure we meet our customers’ expectations.

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

We participate in three distinct market segments:

nucleic acid production, biologics safety testing and protein detection, which together represented approximately $8.4 billion in annual spending in 2019 and which are expected to grow at a 15% compound annual growth rate (“CAGR”) through 2023.

We participate in two distinct market segments:

nucleic acid production and biologics safety testing, which, according to industry consultants, together represented approximately $15.3 billion in annual spending in 2021 and which are expected to

grow at a 8% compound annual growth rate (“CAGR”) through 2024.

Of that combined market, we estimate our addressable portion represents approximately $4.7 billion.

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• Pivot toward mRNA vaccines driven in part by COVID-19 .

The first two vaccines to be approved for use in combating the COVID-19 pandemic were mRNA vaccines, including the vaccine developed by Pfizer and BioNTech.

mRNA vaccine pre-clinical programs grew approximately 38% in 2019, before the COVID-19 pandemic.

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estimated to have increased to approximately 63% in 2020.

The increased growth is being driven, in part, by 34 COVID vaccine programs using mRNA as of March 9, 2021, according to the World Health Organization.

The mRNA vaccine technology is gaining prominence as a result of its faster development time, lower manufacturing costs and improved safety because of the lower risk of unwanted immune responses.

The first two vaccines to be approved for use in combating the COVID-19 pandemic were mRNA vaccines, including the vaccine developed by Pfizer and BioNTech which uses our CleanCap product.

According to the World Health Organization, there are 23 mRNA COVID-19 vaccines in the clinic and an additional 24 mRNA based COVID-19 vaccines in pre-clinical development.

vaccine technology is gaining prominence as a result of its fast development time, lower relative manufacturing costs and improved safety because of the lower risk of unwanted immune responses.

In addition to the COVID-19 vaccines, mRNA technology is being used for other infectious disease vaccines.

There are four influenza vaccines in clinical trials and an additional 50 non-flu vaccines in the clinic and another 84 pre-clinical vaccine programs that have been disclosed.

RNA expertise is highly specialized and customers seek partners to provide these complex products.

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• Rapid growth in development of cell and gene therapies .

Sales of cell and gene therapy drugs are expected to grow from $1 billion in 2019 to $25 billion by 2024 and recent approvals of Kymriah ® , Yescarta ® and Luxturna have added clinical credibility to cell and gene therapies.

We support the development of cell and gene therapies with products used in gene editing and cell therapy research, and we are well positioned to supply materials for gene therapy with the launching of our DNA plasmid products in the first quarter of 2021.

Sales of cell and gene therapy drugs are expected to exceed $30 billion in sales by 2024.

A record number of recent approvals (Abecma, Brevanzi, Imlygic, Rethymic and Stratagraph) were all granted FDA approval in 2021 and have added clinical credibility to cell and gene therapies.

We support the development of cell and gene therapies with products used in gene editing and cell therapy research.

For example, our host cell protein assays are used during the manufacturing of viral vectors and plasmid DNA.

Further, we participate by providing RNA guide strands or mRNA that encodes for gene-editing enzymes, such as Cas9.

• Large and growing pipeline of protein-based therapeutics .

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We expect the impact of COVID-19 on our growth to sustain in the longer-term as the entire mRNA category benefits from lessons learned during the COVID-19 pandemic.

We expect research in other therapeutic categories to experience increased growth as research conducted for COVID-19 diffuses more broadly into other vaccines and therapies.

* Our plasmid DNA products launched in Q1 2021.

We expect research in other mRNA vaccines and therapeutic categories to experience increased growth as research conducted for COVID-19 diffuses more broadly into other vaccines and therapies.

The following table shows the impact COVID-19 has had on our business from 2020 through 2021 and its ongoing longer term impact.

Nucleic Acid Production Market

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Nucleic acid production is a $11.0 billion market expected to grow at 7% annually through 2024.

Growth has generally accelerated in recent years with continued innovation in cell and gene therapy, including mRNA

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therapeutics and synthetic biology approaches.

Growth has generally accelerated in recent years with continued innovation in cell and gene therapy, including mRNA therapeutics and synthetic biology approaches.

Our addressable portion of the market is $3.8 billion with expected growth of 6% annually through 2024.

This higher growth rate is driven by our exposure to high growth sub-markets including RNA cap analog production and mRNA.

This growth rate is driven by our exposure to high growth sub-markets including RNA cap analog production and mRNA.

Capping and mRNA growth is fueled by the continued growth of nucleic acid vaccines and therapies, which we expect will accelerate because of research into COVID-19.

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Capacity to manufacture these products when approved, however, remains in short supply.

Providers of technical expertise and manufacturing capabilities, like ourselves, with the facilities and quality systems demanded by biopharmaceutical customers, benefit from the demand created in the mRNA category.

Providers of technical expertise and manufacturing

capabilities, like ourselves, with the facilities and quality systems demanded by biopharmaceutical customers, benefit from the demand created in the mRNA category.

COVID-19 is further accelerating growth in custom oligonucleotides and related inputs, which are used to manufacture diagnostic tests.

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We participate in the HCP and other process related impurities and viral contamination segments of this market for biopharmaceutical vaccine and therapeutics manufacturing.

These addressable segments account for $575.0 million of the market and are expected to grow at 13% annually through 2023.

These addressable segments account for $0.9 billion of the market and are expected to grow at 12% annually through 2024.

The growth in this market is driven by continued growth of biologics and biosimilars and increased outsourcing of process development.

Protein Detection Market

The protein detection market includes methods to detect and visualize proteins (antigens) in tissue sections to provide insight into gene expression, spatial relationships, and biomarker identification.

Protein detection includes immunohistochemistry, immunofluorescence and glycobiology.

Immunohistochemistry, our largest market within protein detection, is a $2.2 billion market, expected to grow at 8% annually through 2023.

We participate in the immunohistochemistry segment of the academic and biopharmaceutical research market, which represents $200 million of annual expenditures expected to grow at 6% annually through 2023.

This market saw a temporary contraction in 2020 of approximately 15% given lab closures due to COVID-19, but is expected to return to historical numbers.

Our customers strive to improve human health.

Our goal is to provide them with products and services to accelerate their development efforts, from basic research through clinical trials and ultimately to commercialization for drugs, diagnostics and vaccines.

Supporting Biopharmaceutical Customers from Product Development Through Commercialization

Our customers include both emerging and established biopharmaceutical leaders developing novel therapies, diagnostics and vaccines.

Supporting Biopharmaceutical Customers from Product Development Through to Commercialization

Our customers include both emerging and established biopharmaceutical leaders developing novel drugs, therapeutics, diagnostics and vaccines.

Emerging biopharmaceutical customers frequently seek the support we can offer in our state-of-the-art facilities under our stringent quality standards, with the capabilities that result from the capital and process investments we have made over the last several years.

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We believe we are experts in nucleic acids and our scientists aim to develop proprietary enabling technologies that become integral to our customers’ products.

For example, CleanCap®, our proprietary chemical capping technology, has demonstrated its advantages in terms of the stability of the associated mRNA and its efficiency in protein production when compared to

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traditional capping technologies.

For example, CleanCap, our proprietary chemical capping technology, has demonstrated its advantages in terms of the stability of the associated mRNA and its efficiency in protein production when compared to traditional capping technologies.

This efficiency has led biopharmaceutical customers to employ CleanCap in their vaccine and therapeutic programs.

As those products proceed through development into commercialization, we believe CleanCap® will be a critical input in on-market vaccines and therapeutics, with over 110 customers having used CleanCap® as of December 31, 2020 and five COVID-19 vaccine programs incorporating CleanCap® as of March 9, 2021, including two commercial program led by Pfizer in partnership with BioNTech and another led by BioNTech in partnership with Fosun Pharma, one Phase I clinical program led by Chulalongkorn University, one phase I/II clinical programs led by Imperial College London and, one Phase III program led by CureVac, and three pre-clinical programs led by the University of Tokyo in partnership with Daiichi-Sankyo, eTheRNA Immunotherapies and Greenlight Biosciences.

We expect to supply our customers throughout their products’ life cycle.

As those products proceed through development into commercialization, we believe CleanCap will be a critical input in on-market vaccines and therapeutics.

Forming Long-Term Partnerships for Critical Biopharmaceutical Components and Process Tests

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• have a demonstrated adherence to high quality standards;

• be leaders in their market niches;

• be leaders in their market niche(s);

• have differentiated or proprietary products and processes that provide clear value to our biopharmaceutical and other customers;

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We also augment their commercial capabilities through a combination of sales and marketing resources dedicated to each business, supported by our global marketing infrastructure.

We will continue to seek a balance between driving growth organically and through opportunistic acquisitions.

We have relationships with the following categories of customers (percentages represent the share of revenue in each category for the year ended December 31, 2020):

We will continue to seek a balance between driving growth organically and inorganically through opportunistic acquisitions.

We have relationships with the following categories of customers:

developers of therapeutics and vaccines, other biopharmaceutical and life science research companies, academic institutions and molecular diagnostic companies.

Developers of therapeutics and vaccines, including cell and gene therapies, comprise about 85% of our customer base.

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 and distributor management.

We serve customers through direct sales in each business segment, with a primary focus on our larger biopharmaceutical and other

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industry customers.

We serve customers through direct sales in each business segment, with a primary focus on our larger biopharmaceutical and other industry customers.

We serve our academic customers via web, email and phone ordering.

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Our distributors also sell our products in over 50 countries and provide customer service and local sales and marketing.

As of December 31, 2020, our commercial organization included 58 employees and over 83 distributors.

We compete with a range of companies across our segments.

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

and (4) CDMO organizations 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.

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 Inc.

(“Thermo Fisher”) and Hongene Biotech Corporation, who offer alternatives to CleanCap ® .

For mRNA capping analogs, we compete principally with Thermo Fisher and Hongene Biotech Corporation, who offer alternatives to CleanCap.

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

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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 LLC, Bio-synthesis Inc., and System Biosciences, LLC, among others.

For our mRNA offerings, we compete with Aldevron (a subsidiary of Danaher) and System Biosciences, among others.

Based on the Industry Analysis, 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.

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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, Inc., Thermo Fisher and EMD Millipore Corporation (“Millipore Sigma”) serve less complex customer needs while Maravai, LGC Biosearch Technologies, Inc.

and GenScript Biotech Corporation serve more complex customer needs.

Large manufacturers like Integrated DNA Technologies, Thermo Fisher 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.

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Biologics Safety Testing

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

Competitors generally offer fewer expression platforms (as few as one or two) compared to our offering of 23 expression platforms and a total of 78 ELISA impurity detection kits.

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 23 expression platforms and a total of 78 different ELISA 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.

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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

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

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.

Protein Detection

In the protein detection market, we compete against large life sciences manufacturers and niche tissue staining offerings.

We compete in the research segment of this market against large life sciences manufacturers such as Thermo Fisher and Abcam plc, who compete across the value chain offering primary and secondary antibody detection, visual detection and labeling, slide processes and visualization and analysis.

Additionally, we compete against niche tissue staining offerings such as Enzo and Jackson ImmunoResearch Laboratories, Inc.

We are differentiated by our deep visual detection and labeling experience, our Vector Laboratories brand’s sterling reputation established over more than 40 years, and the desire of our research customers to replicate past findings, many of which were completed using Vector Laboratories products.

Licenses and Collaborations

ProteinSimple Supply and Distribution Agreement

On August 12, 2019, we (through Cygnus Technologies) entered into a Supply and Distribution Agreement with ProteinSimple (the “ProteinSimple Agreement”) for the supply of bioprocess impurity assays to be assembled in assay cartridges for use in automated analyzer instruments.

Under the ProteinSimple Agreement, we supply to ProteinSimple, at no charge, certain reagents to be incorporated into ProteinSimple cartridges or sold directly by us.

This collaboration with ProteinSimple is generally exclusive in the field of testing for bioprocess impurities using immunoassays on an automated analyzer for the United States, United Kingdom, Ireland and Europe.

The ProteinSimple Agreement contains non-exclusive licenses from each party to the other to permit the other party to fulfill its obligations and sell its products under the ProteinSimple Agreement.

If any intellectual property is developed jointly or any intellectual property that covers both bioprocess impurity assays and automated immunoassay kits and instruments is developed solely by either party, we will own all intellectual property with respect to the bioprocess impurity assays and ProteinSimple will own all intellectual property with respect to automated immunoassay kits and instruments.

The ProteinSimple Agreement is in effect for an initial seven (7) year term with automatic renewal for successive two (2) year renewal terms unless either party elects not to renew.

Beginning on the third anniversary of the date of the ProteinSimple Agreement, either Party may terminate the ProteinSimple Agreement on thirty (30) days’ notice if Cygnus Technologies has not purchased certain minimum numbers of cartridge kits from ProteinSimple.

Broad Patent License Agreement

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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.

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LSU Patent License Agreement

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The BTI Biosearch Dyes Agreement was originally in effect for a term of two years and is now in a series of annual year-to-year renewals.

Either party has the right to opt-out of such renewals upon 90 days’ notice prior to the next renewal.

Either party has the right to opt-out of such renewals upon ninety (90) days notice prior to the next renewal.

Either party can terminate the agreement for convenience at any time on six months’ written notice.

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Manufacturing and Supply

We occupy facilities in San Diego, California, Burlingame, California, Southport, North Carolina and Sterling, Virginia.

We occupy facilities in San Diego, California, Southport, North Carolina and Sterling, Virginia.

Except for our Sterling facility, all our facilities are engaged in the manufacture of reagents.

Our San Diego facility, in particular, 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 8 and ISO 7 designated customer manufacturing suites and integrated building management systems for required site control.

Our Wateridge facility in San Diego, in particular, 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 8 and ISO 7 designated customer manufacturing suites and integrated building management systems for required site control.

We continue to invest in our San Diego facility with recent expansions allowing for the manufacture of plasmid DNA and creation of ISO Class 8 and ISO Class 7 clean rooms providing for an expansion of the scale at which we can manufacture CleanCap and NTPs, supported by a pilot plant for development of large-scale manufacturing processes.

This investment has

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allowed us to substantially increase our capacity for nucleic acid production and specifically CleanCap ® meeting the growing demand from our customers without interruption or constraints.

Our Southport and Burlingame operations are engaged in the manufacture and processing of antibody, ELISA kits and related reagents.

This investment has allowed us to substantially increase our capacity for nucleic acid production and specifically CleanCap meeting the growing demand from our customers without interruption or constraints.

Our Southport operations are engaged in the manufacture and processing of antibody and ELISA kits.

The facilities incorporate laboratory, manufacturing, bottling, shipping and waste handling capabilities.

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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 Food and Drug Administration (“FDA”) and similar regulatory authorities in other countries for conducting clinical trials and commercializing products for therapeutic, vaccine or diagnostic use.

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.

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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.

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

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.

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Other Regulatory Requirements

Select agent and toxin.

We have one product classified as a select agent and toxin.

Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the United States Department of Health and Human Services (“HHS”) and the United States Department of Agriculture (“USDA”) have established regulatory requirements for the possession, use, and transfer of biological agents and toxins that have the potential to pose a severe threat to public health and safety, animal and plant health, and the safety of animal and plant products for their intended use.

These requirements can be found at 42 CFR Part 73 (HHS), 7 CFR Part 33 1 (USDA-PPQ), and 9 CFR Part 121 (USDA-VS).

The possession, use and transfer of the relevant biological agent and toxin in quantities greater than 1.0 gram is governed by the regulations of 42 CFR Part 73 (HHS), Possession, Use and Transfer of Select Agents and Toxins.

Vector Laboratories is registered with the Center for Disease Control (“CDC”) for these activities, is subject to inspection by the CDC and maintains an approved biosecurity plan.

The regulations include specific requirements for safety (e.g.

handling), security (e.g.

access control, inventory control) and emergency response (e.g.

addressing spills during manufacture or broken containers).

Environmental laws and regulations.

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Our capital and operating expenditures for pollution control in 2020 and 2021 were not material and are not expected to be material in 2022.

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Intellectual Property

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In addition, we protect our ongoing research and development into critical reagents for cell and gene therapy through patents and other intellectual property rights.

As of February 15, 2021, we solely owned 19 issued U.S.

patents including two patents issued in December 2019, and one patent issued in February 2021, for certain of our CleanCap ® products, two pending U.S.

non-provisional patent applications, 29 issued foreign patents and 10 pending foreign patent applications and co-own two issued U.S.

patents and one issued foreign patent with third parties, the details of which are set out in the tables below.

The two foregoing U.S.

patent applications are national stage filings of two PCT patent applications that we solely own.

Our patent portfolio generally includes patents and patent applications relating to compositions and methods for the production of oligonucleotides, nucleic acids and mock viral particles.

patents in our portfolio of company-owned patents are expected to expire between 2021 and 2035.

In addition, certain patents related to our SoluLINK products expired in 2020 and certain other patents related to such products are due to expire in 2021 and 2022.

The following patents and patent applications (including expected 20 year expiration dates) relate to our CleanCap ® related products and technology.

Patent and Patent

Application Numbers

Form of Ownership Expected Expiration Date Description

US 10,494,399, US 10,519,189, US 10,913,768, and foreign applications in certain jurisdictions claiming priority to PCT/US2016/052670 Owned Sept.

20, 2036 Directed to compositions and methods for synthesizing 5’-capped RNAs

The following patents and patent applications (including expected 20 year expiration dates and any patent term adjustment) relate to our CleanTag ® Library Prep related products and technology.

Patent Numbers Form of Ownership Expected Expiration Date Description

US 8,728,725 Owned Jan.

5, 2032 Directed to compositions and methods for ligation of nucleic acids

US 9,631,227 Owned Nov.

10, 2030 Directed to compositions and methods for ligation of nucleic acids

AU Patent No.

2010270715 Owned July 6, 2030 Directed to compositions and methods for ligation of nucleic acids

CA Patent No.

2,767,408 Owned July 6, 2030 Directed to compositions and methods for ligation of nucleic acids

EP Patent No.

2451980 (validated in DE, ES, FR, GB, IT) Owned July 6, 2030 Directed to compositions and methods for ligation of nucleic acids

ES Patent No.

2521740 Owned July 6, 2030 Directed to compositions and methods for ligation of nucleic acids

HK Patent No.

1220234 Owned July 6, 2030 Directed to compositions and methods for ligation of nucleic acids

JP Patent No.

5903379 Owned July 6, 2030 Directed to compositions and methods for ligation of nucleic acids

MX Patent No.

321180 Owned July 6, 2030 Directed to compositions and methods for ligation of nucleic acids

NZ Patent No.

597535 Owned July 6, 2030 Directed to compositions and methods for ligation of nucleic acids

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The following patents and patent applications (including expected 20 year expiration dates and any patent term adjustment) relate to our CleanAmp ® related products and technology.

Patent Numbers Form of Ownership Expected Expiration Date Description

US 8,133,669 Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

AU Patent No.

2009257815 Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

CA Patent No.

2,725,239 Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

CN Patent No.

102105481 Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

EP Patent No.

2294076 (validated in DE, ES, FR, GB, IT) Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

ES Patent No.

2625938 Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

GB Patent No.

2473778 Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

HK Patent No.

1155456 Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

IN Patent No.

318293 Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

JP Patent No.

5712125 Owned May 21, 2029 Directed to compositions and methods for nucleic acid replication

US 8,361,753 Owned October 21, 2029 Directed to compositions and methods for nucleic acid amplification

AU Patent No.

2007268075 Owned May 17, 2027 Directed to compositions and methods for nucleic acid amplification

CA Patent No.

2,653,841 Owned May 17, 2027 Directed to compositions and methods for nucleic acid amplification

CN Patent No.

101517091 Owned May 17, 2027 Directed to compositions and methods for nucleic acid amplification

DE Patent No.

602007013223 Owned May 17, 2027 Directed to compositions and methods for nucleic acid amplification

EP Patent No.

2032714 (validated in DE, ES, FR, GB, IT) Owned May 17, 2027 Directed to compositions and methods for nucleic acid amplification

ES Patent No.

2360738 Owned May 17, 2027 Directed to compositions and methods for nucleic acid amplification

HK Patent No.

1129045 Owned May 17, 2027 Directed to compositions and methods for nucleic acid amplification

JP Patent No.

5558811 Owned May 17, 2027 Directed to compositions and methods for nucleic acid amplification

The following patent (including expected 20 year expiration dates and any patent term adjustment) relates to our decanoic acid diester linker-related technology.

Patent Numbers Form of Ownership Expected Expiration Date Description

US 6,320,041 Owned April 13, 2021 Directed to compositions used for chemical joining molecules to oligonucleotide

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The following patents and patent applications (including expected 20 year expiration dates and any patent term adjustment) relate to our SoluLINK ® related products and technology.

Patent Numbers Form of Ownership Expected Expiration Date Description

US 6,686,461 Owned Feb.

28, 2021 Directed to methods and compositions for preparation, detection and immobilization of macromolecules including oligonucleotides

US 7,173,125 Owned Jan.

29, 2022 Directed to methods and compositions for preparation, detection and immobilization of macromolecules including oligonucleotides

US 7,999,098 Owned Jan.

29, 2022 Directed to methods and compositions for preparation, detection and immobilization of macromolecules including oligonucleotides

US 6,800,728 Owned June 28, 2021 Directed to methods and compositions for crosslinking and immobilizing biomolecules, drugs and synthetic polymers

US 7,462,689 Owned July 15, 2021 Directed to methods and compositions for crosslinking and immobilizing biomolecules, drugs and synthetic polymers

US 7,732,628 Owned Sept.

6, 2023 Directed to methods and compositions for immobilizing biomolecules, drugs and synthetic polymers

US 7,102,024 Owned Sept.

6, 2023 Directed to methods and compositions for immobilizing biomolecules

US 6,911,535 Owned Mar.

31, 2022 Directed to methods for immobilizing biomolecules

US 8,541,555 Owned April 8, 2031 Directed to methods and compounds used to label biomolecules

US 8,846,875 Owned Feb.

11, 2031 Directed to methods, systems, and kits for preparing, purifying, and isolating oligonucleotide conjugates

EP Patent No.

1315699 (validated in FR, DE, GB) Owned Mar.

22, 2021 Directed to methods and compositions for crosslinking and immobilizing biomolecules, drugs and synthetic polymers

EP Patent No.

2295407 (validated in FR, DE, GB) Owned Mar.

22, 2021 Directed to methods and compositions for crosslinking and immobilizing biomolecules, drugs and synthetic polymers

EP Patent No.

2298736 (validated in FR, DE, GB) Owned Mar.

22, 2021 Directed to methods and compositions for crosslinking and immobilizing biomolecules, drugs and synthetic polymers

The following patents and patent applications (including expected 20 year expiration dates) relate to our immunofluorescence assay related products and technology.

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Patent Application Numbers Form of Ownership Expected Expiration Date Description

US Patent App.

15/970,100, and foreign applications in certain jurisdictions claiming priority to PCT/US2018/030799 Owned May 3, 2038 Directed to kits and methods related to immunofluorescence assays

US Patent App.

16/195,208, and foreign applications in certain jurisdictions claiming priority to PCT/US2018/061807 Owned Nov.

19, 2038 Directed to systems and methods for immunoassay detection

The following patents and patent applications (including expected 20 year expiration dates) relate to our immunofluorescence assay related products and technology.

Patent Numbers Form of Ownership Expected Expiration Date Description

US 6,770,754 Owned Nov.

29, 2021 Directed to compositions and methods related to oligonucleotide synthesis

US 7,491,817 Owned Nov.

29, 2021 Directed to compositions and methods related to oligonucleotide synthesis

EP Patent No.

1404695 (validated in BE, CH, DE, FR, GB) Owned Nov.

29, 2021 Directed to compositions and methods related to oligonucleotide synthesis

EP Patent No.

2248820 (validated in BE, CH, DE, FR, GB) Owned Nov.

29, 2021 Directed to compositions and methods related to oligonucleotide synthesis

Patent Numbers Form of Ownership Expected Expiration Date Description

US 8,394,948 Co-owned with Nelson Biotechnologies Sept.

28, 2030 Directed to compositions and methods related to oligonucleotide synthesis

Patent Numbers Form of Ownership Expected Expiration Date Description

US 7,144,995 Co-owned with Berry & Associates June 1, 2024 Directed to compositions and methods related to fluorescent nitrogenous bases

EP Patent No.

1483280 (validated in CH, DE, FR, GB) Co-owned with Berry & Associates Mar.

6, 2023 Directed to compositions and methods related to fluorescent nitrogenous bases

PCT patent applications are not eligible to become an issued patent until, among other things, we file one or more national stage patent applications within, depending on the country, 30 to 32 months of the PCT application’s priority date in the countries in which we seek patent protection.

Moreover, we may own provisional patent applications in the future, and provisional patent applications are not eligible to become issued patents until, among other things, we file a non-provisional patent application within 12 months of filing of one or more of related provisional patent applications.

If we do not timely file any national stage patent applications or non-provisional patent applications, we may lose our priority date with respect to our PCT patent applications or provisional patent applications and any patent protection on the inventions disclosed in such patent applications.

While we intend to timely file national stage patent applications relating to our PCT patent applications and non-provisional patent applications relating to our 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.

Individual 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 filed in the United States are granted a term of 20 years from the earliest effective filing date of a non-provisional patent application.

The duration of foreign patents varies in accordance with provisions of applicable local law, but typically is also 20 years from the earliest effective filing date.

Our patent portfolio generally includes patents and patent applications relating to compositions and methods for the production of 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 21 years from the earliest effective filing date of a non-provisional patent application.

Issued patents may be extended beyond the natural 21 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.

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

Jurisdiction Patent Number Title Expiration

United States 10494399

Compositions and methods for synthesizing 5′-Capped RNAs

United States 10519189

Compositions and methods for synthesizing 5′-Capped RNAs

United States 10913768

Compositions and methods for synthesizing 5′-Capped RNAs

Europe 3352584

Compositions and methods for synthesizing 5′-Capped RNAs

Australia 2016328645

Compositions and methods for synthesizing 5′-Capped RNAs

Japan 6814997

Compositions and methods for synthesizing 5′-Capped RNAs

The following patent relates to our oligonucleotide synthesis support technology.

Jurisdiction Patent Number Title Expiration

United States 7491817

Universal Supports for Oligonucleotide Synthesis

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

Jurisdiction Patent Number Title Expiration

United States 9632087

Methods for evaluating viral clearance from a biopharmaceutical solution employing mock viral particles

United States 10309963

Methods for evaluating viral clearance from a process solution employing mock viral particles

Europe 3044339

Methods and kits for quantifying the removal of mock virus particles from a purified solution

Australia 2014320015 Methods and kits for quantifying the removal of Mock Virus Particles from a purified solution

China 105899684

Method and kit for quantifying pseudoviral particles removed from purified solution

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, subsidiary names Cygnus ® and TriLink ® and various product names, such as CleanCap ® .

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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.

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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.

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.

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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 “Risk Factors—Risks Related to our Intellectual Property.”

For more information regarding risks related to intellectual property, please see Item 1A.

“Risk Factors—Risks Related to our Intellectual Property.”

Human Capital Resources

As of December 31, 2021, we had over 470 full-time employees.

Among our employees, 41% identify as female and 59% identify as male.

Among our employees, 43% identified as female and 57% identified as male.

Approximately 19% of our employees had advanced degrees.

None of our employees is represented by a labor union, and none of our employees has entered into a collective bargaining agreement with us.

We offer a highly competitive compensation and benefits program to attract and retain top talent.

We offer a highly competitive compensation and benefits program to attract and retain top talent, and all employees receive equity awards under our 2020 Omnibus Incentive Plan.

Our talented employees drive our mission and share core values that both stem from and define our culture, which plays an invaluable role in our execution at all levels in our organization.

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• Open Communication .

We focus on open source sharing with our focus on constant improvement as individuals and as an organization.

We focus on open door sharing with our focus on constant improvement as individuals and as an organization.

• Quality Mindset .

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We celebrate and recognize accomplishments, both individual and collectively.

We are committed to the health, safety and well-being of our employees.

All employees exposed to potential hazards are required to complete annual health and safety training, including laboratory chemical safety, hazard communication and hazardous waste management.

To better track, report and improve upon occupational health and safety, we have implemented a health and safety management system that includes an online incident reporting platform across all sites.

To mitigate the impact of COVID-19 on our employees, we instituted new processes, guidelines and preparedness measures within the context of each of our offices’ unique culture and geographies.

For example, employees in our San Diego facilities received free weekly mandatory COVID-19 testing, and each employee wore contract tracing devices to assist with contact tracing in the event of exposure.

We also implemented outreach efforts focusing on the mental health of our employees on topics such as anxiety, depression, sleep, stress and substance abuse.

Through our employee assistance program, employees are offered up to three sessions with licensed counseling professionals at no cost to the employee, as well as additional online resources.

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, Current Reports on Form 8-K, and our Proxy Statements, and any amendments to these reports, are available through our investor relations website, free of charge, after we file 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, and blogs.

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business