Maravai LifeSciences Holdings, Inc.
−Removed: (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.
+Added: (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 novel vaccines, drug therapies, and diagnostics, 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.
−Removed: Our products address the key phases of biopharmaceutical development spanning research to commercialization and include complex nucleic acids for diagnostic, vaccine and therapeutic applications, and antibody-based products to detect impurities during the production of biopharmaceutical products.
+Added: Our products address the key phases of biopharmaceutical development spanning research to commercialization and include complex nucleic acids for vaccine, therapeutic and diagnostic applications, custom enzymes for research and diagnostic use and antibody-based products to detect impurities during the production of biopharmaceutical products.
+Added: We provide products that support our customers from discovery through commercialization of their vaccines, therapeutic agents and in vitro diagnostic 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.
−Removed: There are more than 2,000 cell and gene therapies in development or launched and sales in this category are expected to grow more than 5 times by 2027, according to industry consultants and management estimates.
+Added: There are more than 4,000 nucleic acid and cell and gene therapies in development or launched and sales in this category are expected to grow more than 3 times by 2030, according to industry consultants and management estimates.
Our portfolio offers key products for each stage of the cell and gene therapy development lifecycle.
−Removed: For example, our messenger RNA (“mRNA”) products are used in drug development to assist in the production of immune-activating antigens;
+Added: For example, our messenger RNA (“mRNA”) products are used in drug development to assist in the production of immune-activating antigens and to deliver gene editing technologies in cell and gene therapy treatments;
our CleanCap® technology is used to stabilize mRNA and streamlines mRNA manufacturing;
−Removed: we were one of the first companies to provide the essential modified uridine, N1-methyl-pseudouridine triphosphate, for research applications;
+Added: we were one of the first companies to provide the essential modified uridine, N1-methyl-pseudouridine triphosphate, for research applications and under good manufacturing processes (“GMP”) conditions;
our catalog mRNA products are frequently used by lipid developers to test and validate new mRNA delivery platforms;
−Removed: and our plasmid DNA products are used as templates for the production of our ribonucleic acid mRNA products.
−Removed: Our oligonucleotide and oligonucleotide supply products are included in the supply chain of several diagnostic platforms.
+Added: and our plasmid DNA products are used as templates for the production of our mRNA products.
+Added: Our oligonucleotides, oligonucleotide supply products, enzymes and NTPs are also included in the supply chain of several diagnostic, next-gen sequencing (“NGS”) and research platforms, as well as DNA and RNA synthesis end-markets.
We also provide biologics safety testing technology used to ensure the safety of the biological drug manufacturing process and drug products.
−Removed: 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.
−Removed: 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.
−Removed: Notably, according to research commissioned by us in November 2021 consisting of over 55 interviews and in November 2022 consisting of 30 additional 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.
+Added: Among other capabilities, we are experts in RNA and mRNA products, which are challenging and often unstable molecules requiring significant chemical modifications and analytical expertise to ensure their stability and efficacy in our customers’ applications.
+Added: Notably, according to research commissioned by us consisting of 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 technology 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.
−Removed: CleanCap had been incorporated into several mRNA programs targeting immunization against the novel strain of coronavirus, SARS-CoV-2 (“COVID-19”).
−Removed: programs included two commercial programs led by Pfizer in partnership with BioNTech and one led by BioNTech in partnership with Fosun Pharma, as well as the bivalent booster vaccine developed by Pfizer in partnership with BioNTech to address the Omicron strain of the virus.
−Removed: In addition to these commercialized programs, CleanCap has been incorporated into many earlier stage programs addressing COVID-19 that have not yet been commercialized.
−Removed: Additionally, the U.S.
−Removed: 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.
−Removed: 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.
−Removed: We believe our CleanCap products have also been incorporated into vaccine development programs from several of our licensed clients for infectious diseases, including Influenza, lyme disease, malaria, HIV, tuberculosis, shingles, rabies, yellow fever, respiratory syncytial virus (“RSV”) and Zika.
−Removed: We estimate our mRNA and CleanCap products have also been incorporated in over 250 vaccine and therapeutic programs in development as of December 31, 2022, including at least 60 programs that our mRNA CDMO services group manufactured the mRNA APIs using CleanCap.
+Added: CleanCap analogs have been incorporated into several mRNA programs targeting
+Added: immunization against the coronavirus, SARS-CoV-2 (“COVID-19”).
+Added: These programs include commercial programs led by Pfizer in partnership with BioNTech and by BioNTech in partnership with Fosun Pharma, as well as two COVID-19 vaccines which are now approved for use in Japan.
+Added: In addition to these commercially approved programs, CleanCap has been incorporated into many research and clinical stage programs addressing stand-alone and combination vaccines for COVID-19 and other respiratory diseases, such as Influenza that have not yet been commercialized.
+Added: We estimate our CleanCap products have been incorporated in approximately 350 vaccine and therapeutic programs in development as of December 31, 2023, including at least 60 molecules for which our mRNA CDMO services group manufactured the mRNA APIs using CleanCap.
+Added: These include vaccine development programs for infectious diseases, including Lyme disease, malaria, HIV, tuberculosis, shingles, rabies, yellow fever, respiratory syncytial virus (“RSV”) and Zika, as well as other medical conditions.
In addition to infectious diseases, these 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.
−Removed: These therapeutic programs also use multiple therapeutic modalities, including CRISPR/Cas-9, transcription activator-like effector nuclease (TALENS), enzyme replacement therapies, allogeneic CAR-T cells and base editing.
+Added: These therapeutic programs also use multiple therapeutic modalities, including CRISPR/Cas-9, transcription activator-like effector nuclease (TALEN), enzyme replacement therapies, allogeneic CAR-T cells and base editing.
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.
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Process development is a complex phase that establishes highly validated procedures and determines the investment in facilities and equipment required to bring biopharmaceutical products to market.
−Removed: These decisions impact the viability of our customers’ products for the long term.
+Added: These decisions impact the viability of our customers’ products for use in clinical trials and commercialization.
During process development, we provide enzyme-linked immunosorbent assays (“ELISAs”) that reduce the risk posed by impurities and contaminants in biological drugs, a critical step to ensure the safety of the drug product.
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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.
−Removed: Once our services or products are qualified by our customers, we are written into regulatory documents and standard operating procedures.
+Added: Once our services or products are qualified by our customers, they are often cited in regulatory documents and standard operating procedures.
As a result, our customer relationships frequently span many years.
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As of December 31, 2023, approximately 24% of our workforce have earned advanced degrees and all receive rigorous training on our procedures.
−Removed: We manufacture our nucleic acid products at our San Diego, California facility (“Wateridge facility”).
−Removed: 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.
+Added: During 2023, the majority of our nucleic acid products were manufactured at our San Diego, California Wateridge facility (“Wateridge facility”).
+Added: The Wateridge facility was purpose-built to address our customers’ needs for critical raw materials manufactured under certain 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.
−Removed: We believe our products are exempt from compliance with the current GMP (“cGMP”) regulations of the
−Removed: 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.
−Removed: As of December 31, 2022, we had invested $90.9 million in our Wateridge facility.
+Added: 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.
Our other facilities are similarly designed for specific applications with quality systems to match our customers’ requirements.
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Our Portfolio and Capabilities
−Removed: We provide products that support our customers’ needs from discovery through commercialization of their vaccines, therapeutic agents and in vitro diagnostic products.
−Removed: Our products are frequently incorporated into our customers’ products, whether as research products or APIs used in development or research products incorporated as raw materials into on-market products.
+Added: We provide critical raw materials that support our customers from discovery through commercialization of their vaccines, therapeutic agents and in vitro diagnostic products.
+Added: Our products are frequently incorporated into our customers’ products, whether as research products or APIs used in development or products incorporated as raw materials into on-market products.
They may also be incorporated into the manufacturing process itself.
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Our products address our customers’ needs for Nucleic Acid Production and Biologics Safety Testing, and our operations are aligned to these two segments.
−Removed: Our products and the end markets they serve are depicted in the following image:
+Added: Within Nucleic Acid Production, we have four business units:
+Added: TriLink Discovery, TriLink GMP, Glen Research and Alphazyme.
+Added: Our Biologics Safety Testing business is comprised of Cygnus Technologies.
+Added: Our brands, products and the end markets they serve are depicted in the following image:
Nucleic Acid Production (78% of Revenue for the Year Ended December 31, 2023)
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We have recognized expertise in complex chemistries and products provided under exacting quality standards.
−Removed: Our core offerings include mRNA, long and short oligonucleotides, our proprietary CleanCap mRNA capping technology, mRNA building blocks and oligonucleotide building blocks.
+Added: 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 GMP-grade raw materials and API manufacturing.
−Removed: We market our nucleic acid products under the TriLink BioTechnologies® and Glen Research brands.
−Removed: 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.
−Removed: mRNA as a treatment modality has been an area of acute interest for many years.
+Added: We market our nucleic acid products under the TriLink BioTechnologies®, Glen Research and Alphazyme brands.
+Added: Since the 1961 discovery of mRNA and its role in converting genetic information into proteins, countless attempts had been made to harness mRNA for therapeutic purposes.
+Added: Today, mRNA vaccines are globally recognized for their success in responding to the COVID-19 pandemic.
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
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We offer the following nucleic acid products:
−Removed: mRNA, RNA Capping (CleanCap), oligonucleotides, oligonucleotide inputs, nucleoside triphosphates, custom nucleic acid chemistry and plasmid DNA.
+Added: mRNA, RNA Capping (CleanCap), oligonucleotides, oligonucleotide inputs, nucleoside triphosphates, custom nucleic acid chemistry, plasmid DNA and specialty enzymes.
mRNA is an intermediary molecule that translates the genetic information stored in DNA into proteins.
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We offer both research grade material and material made under GMP conditions for early phase clinical trials.
−Removed: Within the mRNA category, we also offer our CleanCap products.
−Removed: Our proprietary CleanCap analogs principally serve the mRNA vaccine and therapeutics markets, including vaccine candidates in development for immunizing against COVID-19.
+Added: Within the mRNA category, we also offer our patented CleanCap technology.
+Added: 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.
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We offer a suite of CleanCap analogs that are specifically made for therapeutics and vaccines.
−Removed: Based on the Industry Analysis, we believe our cap analogs are critical features of several mRNA vaccines in development.
+Added: CleanCap analogs are sold as a stand-alone reagents or bundled with other mRNA products.
+Added: Based on the Industry Analysis, we believe our cap analogs are critical features of several mRNA vaccines and therapies in development.
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.
−Removed: While capping efficiency is usually high, the extra processing steps typically result degradation and mRNA of poorer quality.
+Added: 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.
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This avoids the workflow challenges of the enzymatic process, but typically results in lower yields.
−Removed: Like ARCA, CleanCap is a synthetic, chemically-made mRNA 5’ cap analog added to the transcription process in a single step.
+Added: 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.
−Removed: When compared to enzymatic capping, CleanCap removes the
−Removed: additional downstream purification steps required.
−Removed: We have developed a suite of CleanCap analogs that are specifically designed for therapeutics and vaccines.
−Removed: CleanCap is sold as a stand-alone reagent or bundled with other mRNA products.
+Added: 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.
−Removed: CleanCap is in two quality grades, research use only for discovery and development activities, and a GMP-grade for clinical and commercial applications.
+Added: CleanCap is available in two quality grades, research use only for discovery and development activities, and a GMP-grade for clinical and commercial applications.
+Added: 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 69% of our Nucleic Acid Production revenue for the year ended December 31, 2023 (including the revenue from CleanCap products).
Oligonucleotides.
−Removed: The oligonucleotide product category supports broad customer applications, including therapeutics, in vitro diagnostics, next generation sequencing (“NGS”) and CRISPR-based gene editing.
+Added: 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 research grade or under GMP conditions for use in development, clinical and commercial applications.
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Plasmid DNA is frequently used as a vector for replicating nucleic acid products.
−Removed: Plasmid DNA is integral to the production of mRNA, serving as the nucleic acid template for the DNA-dependant RNA polymases that frequently are used in the manufacturing of mRNA.
+Added: Plasmid DNA is integral to the production of mRNA, serving as the nucleic acid template for the DNA-dependent RNA polymerases that frequently are used in the manufacturing of mRNA.
Our plasmid DNA offering allows us to ensure the quality and timeliness of the mRNA API manufacturing campaigns that we service for our customers.
+Added: Specialty Enzymes.
+Added: Through our acquisition of Alphazyme in the first quarter of 2023, our Nucleic Acid Production capabilities now include specialized enzymes.
+Added: Enzymes are critical to almost every phase of nucleic acid production.
+Added: Alphazyme provides custom, scalable molecular biology enzymes with a full product line of IVT, NGS, life science and diagnostic enzyme solutions.
+Added: Discovery mRNA synthesis .
+Added: Through the TriLink BioTechnologies Discovery Business unit, we offer a core set of products and services geared toward customers doing early-stage development work.
+Added: We produce mRNA utilizing standard sequences for generalized research using customer supplied sequences for custom built constructs.
+Added: We also provide process development services to optimize customers’ transcription and purification processes.
+Added: These services can be integrated with our CleanCap, NTP products and enzyme portfolios and have access to our analytical and QC method development.
+Added: GMP mRNA synthesis .
+Added: Our GMP mRNA manufacturing services offer a clear pathway for customers running clinical trials.
+Added: 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.
+Added: Our services feature robust quality management systems and include process development and scale-up, phase-appropriate, high-quality plasmid DNA, regulatory submission support, and in-house analytical services for mRNA analysis and characterization.
Biologics Safety Testing (22% of Revenue for the Year Ended December 31, 2023)
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For over 25 years, the Cygnus Technologies brand has been associated with products and services that enable the detection of impurities present in bioproduction.
−Removed: Our biologics safety testing products are used during development and scale-up, during the regulatory approval process and throughout commercialization.
+Added: Our biologics safety testing products are used during development and scale-up, during the regulatory approval process and
+Added: 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.
−Removed: These include monoclonal antibodies and recombinant proteins, both as novel biologics and biosimilars, and recombinant vaccines, including vaccines to prevent COVID-19 and to treat cancer.
−Removed: We also provide products in support of the development of cell and gene therapies.
+Added: These include monoclonal antibodies and recombinant proteins, both as novel biologics and biosimilars, and recombinant vaccines, including oncolytic vaccines to treat cancer.
+Added: 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.
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All of the 19 existing FDA-and EMA-approved CAR-T Cell and Gene Therapies use Cygnus Host Cell Protein ELISA kits for HCP testing for commercial product lot release.
−Removed: Five of these 15 therapies were approved in 2022.
+Added: Four of these 19 therapies were approved in 2023.
ELISA is the benchmark method for monitoring levels of process-related impurities during the purification process and in product release testing.
−Removed: The advantages of well-developed ELISA kits include the ability to measure very low levels of
−Removed: impurities in the presence of high amounts of drug product, without requiring a high level of expertise to execute and interpret, and are readily transferable across an organization from process development to manufacturing and quality control bioanalytical groups.
+Added: 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.
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Some customers may choose to use generic assays early in development and migrate to process-specific assays later.
−Removed: The trend in recent years has been for customers to increasingly use generic assays throughout their development pathway, relying on our expertise and the established performance of our assays.
+Added: The trend in recent years has been for customers to increasingly use generic assays throughout their development and commercialization pathway, relying on our expertise, 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 cover 24 expression platforms and provides the specificity and sensitivity to detect impurities with reproducibility, which supports regulatory compliance.
−Removed: 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.
+Added: 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.
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HCP ELISA kits.
−Removed: HCP ELISAs are kits used to detect residual proteins from the expression system used in bioproduction.
+Added: HCP ELISA kits are bioassays used to detect residual proteins from the expression system 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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In 2022, Cygnus Technologies introduced MockV® RVLP Kit.
−Removed: This kit enables bioprocess scientists to quantify the removal of Retrovirus-like Particles
−Removed: (RVLPs) produced endogenously by Chinese Hamster Ovary (CHO) cell lines during biopharmaceutical manufacturing.
+Added: This kit enables bioprocess scientists to quantify the removal of Retrovirus-like Particles (RVLPs) produced endogenously by Chinese Hamster Ovary (CHO) cell lines during biopharmaceutical manufacturing.
The kit includes a highly purified and concentrated stock solution of RVLP, an actual non-infectious retrovirus-like contaminant generated during CHO production.
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Our Competitive Strengths
−Removed: We believe we are a leader in providing nucleic acid products and biologics safety testing products and services to biopharmaceutical customers worldwide.
−Removed: 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.
+Added: We believe we are a leader in providing nucleic acid products and services and biologics safety testing products and services to biopharmaceutical customers worldwide.
+Added: 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
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Based on the responses to the Industry Analysis, we believe the solutions we provide, in many cases, cannot be provided effectively by our competitors.
−Removed: In certain cases, like our CleanCap technology, our know-how is backed by intellectual property.
+Added: 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.
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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.
−Removed: CleanCap, for example, offers advantages over competing capping technologies in yield, stability and safety.
+Added: 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.
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Trusted Brands
−Removed: Our TriLink BioTechnologies, Glen Research, and Cygnus Technologies brands are well known in their respective markets for consistent quality and performance.
+Added: 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.
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Our customers further expect that we have the production capacity to meet their needs in a timely manner.
−Removed: As of December 31, 2022, we had invested approximately $90.9 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.
−Removed: Additionally, this investment in our Wateridge facility allows us to meet our customers demand for our nucleic acid products, including
−Removed: We similarly invest in our other sites to ensure we meet our customers’ expectations.
−Removed: Throughout 2022 we invested in additional facilities that we expect to bring online operationally in 2023, including 1) an additional facility in San Diego, California to further support GMP-grade manufacturing and to support customers into Phase II clinical trials and beyond, and 2) a new state of the art facility in Leland, North Carolina to further support the Biologics Safety Testing business.
−Removed: We believe that the capacity to manufacture to stringent biopharmaceutical standards is constrained within the industry and our ability to meet this demand sets us apart from our competition.
+Added: Maravai has designed and constructed four world-class manufacturing facilities, and since 2022 has expanded the company’s facility footprint by over 95,000 square feet to support expanded capabilities and future growth.
+Added: As of December 31, 2023, we had invested approximately $93.2 million into our flagship San Diego, California Wateridge facility and its dedicated manufacturing suites to produce materials from Research Use Only (“RUO”) to GMP conditions, along with the required quality systems to meet requirements specified by our customers.
+Added: This investment in our Wateridge facility allows us to meet our customers’ demand for our nucleic acid products, including CleanCap.
+Added: In January 2023, we moved into a new state-of-the-art facility in Leland, North Carolina to increase our manufacturing and development capacity to further support the Biologics Safety Testing business.
+Added: In March 2023, we expanded our San Diego, California manufacturing campus by making a significant investment in additional cleanroom and small molecule manufacturing space, implementing automation systems and adding support areas to augment production capacity with the Flanders 1 facility (“Flanders 1 facility”) for GMP small molecule production.
+Added: This facility provides site redundancy for our Wateridge facility and features five GMP suites that can operate in parallel.
+Added: In June 2023, we finished construction and took occupancy of an additional 32,000 square-foot facility in San Diego (“Flanders 2 facility”) for GMP-grade mRNA manufacturing to support customers progressing into Phase II clinical trials and beyond.
+Added: In June 2023, we expanded the Alphazyme facility in Jupiter, Florida to add an additional research and development (“R&D”) space to support our specialized enzyme development.
Experienced Leaders and Talented Workforce
Our management includes experienced leaders with demonstrated records of success at Maravai and other highly regarded industry participants.
+Added: They have decades of combined experience and expertise on the forefront of life sciences innovation.
In addition, as of December 31, 2023, approximately 24% of our workforce have earned advanced degrees and all receive rigorous on the job training.
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We participate in two distinct market segments:
−Removed: nucleic acid production and biologics safety testing, which, according to industry consultants, together represented approximately $15.2 billion in annual spending in 2022.
−Removed: Of that combined market, we estimate our addressable portion represents approximately $3.7 billion.
+Added: Nucleic Acid Production and Biologics Safety Testing.
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.
−Removed: There are more than 2,000 cell and gene therapies in development or launched and sales in this category are expected to grow more than five times by 2027, according to industry consultants and management estimates.
−Removed: While we expect near-term declines in overall market demand for COVID-related products, we expect to benefit from favorable industry dynamics in our broader market segments and specific growth drivers in our addressable market segments.
Biopharmaceutical customers are increasingly relying on outside parties to provide important raw material inputs and services for their clinical research and manufacturing, a development driving growth for suppliers with unique capabilities, high quality and the ability to manufacture at a relevant scale to support customer programs.
−Removed: We believe that suppliers like ourselves, with this rare combination of capabilities, proprietary products and the required investment in manufacturing and quality systems, are benefiting from rapid growth as biopharmaceutical customers seek to partner with a small number of trusted partners.
+Added: We believe that suppliers like ourselves, with
+Added: this rare combination of capabilities, proprietary products and the required investment in manufacturing and quality systems, are benefiting from rapid growth as biopharmaceutical customers seek to partner with a small number of trusted partners.
In addition to the continued trend toward outsourcing, several market developments should contribute to long-term growth in our addressable market segments, including:
• Pivot toward mRNA vaccines and therapeutics for non-COVID indications has been accelerated in part by COVID-19 .
−Removed: The first two vaccines approved for use in combating the COVID-19 pandemic were mRNA vaccines,
−Removed: including the vaccine developed by Pfizer and BioNTech which uses our CleanCap product.
−Removed: Our CleanCap product is also incorporated into the bivalent booster vaccine developed by Pfizer and BioNTech.
+Added: The first two vaccines 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.
+Added: Our CleanCap product is also incorporated into the booster vaccines developed by Pfizer and BioNTech.
The mRNA platforms are gaining prominence as a result of their fast development time, lower relative manufacturing costs and proven safety profile.
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In addition to the COVID-19 vaccines, mRNA technology is being investigated for a spectrum of other infectious diseases as well as cancer vaccines, including personalized medicine vaccines.
−Removed: We expect research in other mRNA vaccines to experience increased growth as research conducted for COVID-19 diffuses more broadly into other vaccines and therapies.
RNA expertise is highly specialized, and customers seek partners with our expertise to provide these complex products.
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• Rapid growth in development of cell and gene therapies .
−Removed: Five new cell and gene therapy approvals (Carvykti, Roctavian, Upstanza, Hemgenix, Adstiladrin) were all granted FDA or EMA approval in 2022 and have added clinical credibility to cell and gene therapies.
+Added: Seven new cell and gene therapy approvals (Omisirge, Vyjuvek, Roctavian, Lantidra, Casgevy, Lyfgenia, Elvidys) were all granted FDA or EMA approval in 2023 and have added clinical credibility to cell and gene therapies.
Our internal analysis, supported by third-party research, projects that by 2027, 20-30% of the mRNA pipeline assets will be for in vivo gene editing and ex vivo gene-edited cell therapies.
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Nucleic Acid Production Market
−Removed: The nucleic acid production market includes the production and synthesis of reagents for research and manufacturing of DNA and RNA-based biologics.
−Removed: Nucleic acid production was an $11.0 billion market in 2022.
−Removed: Market growth generally accelerated in recent years until the middle of 2022 due to continued innovation in cell and gene therapy, including mRNA therapeutics and synthetic biology approaches, and particularly as a result of mRNA manufacturing of COVID-19 vaccines.
+Added: 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.
The field of mRNA-based drugs and vaccines has advanced dramatically within a few short years.
−Removed: 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.
1 unchanged sentence
The biologics safety testing market includes the detection and clearance of downstream bioprocessing product-related and process-related impurities.
−Removed: Biologics safety testing is a $4.2 billion market in 2022.
We participate in the HCP and other process related impurities and viral contamination segments of this market for biopharmaceutical vaccine and therapeutics manufacturing.
5 unchanged sentences
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.
−Removed: We are capable of manufacturing reagents from research-grade to GMP-grade, which
−Removed: often exceeds the in-house capabilities of our pre-commercial customers.
+Added: We are capable of manufacturing reagents from research-grade to GMP-grade, which often exceeds the in-house capabilities of our pre-commercial customers.
The results of the Industry Analysis indicate that our emerging and established customers also seek us out for our leading capabilities in nucleic acid chemistries and process control assays.
33 unchanged sentences
developers of therapeutics and vaccines, other biopharmaceutical and life science research companies, academic institutions and molecular diagnostic companies.
−Removed: 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.
31 unchanged sentences
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.
+Added: For our specialty enzymes offering, we compete with New England Biolabs, Thermo Fisher, QIAGEN, and Roche, among others.
+Added: 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”).
−Removed: Competitors generally offer fewer expression platforms (generally between one and three)
−Removed: compared to our offering of 23 expression platforms and over 75 different impurity detection kits.
+Added: 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.
12 unchanged sentences
The term of the Broad Patent License Agreement extends through the expiration of the last to expire claim of any of the licensed patents.
−Removed: 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.
+Added: 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
+Added: 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.
−Removed: LSU Patent License Agreement
−Removed: We (through TriLink BioTechnologies) entered into a Patent License Agreement with the Board of Supervisors of Louisiana State University and Agricultural and Mechanical College and Dr.
−Removed: Edward Darzynkiewicz (collectively, “LSU”) effective as of July 7, 2010 (the “LSU Patent License Agreement”).
−Removed: Under the LSU Patent License Agreement, LSU grants to us a non-exclusive, royalty-bearing license under an issued U.S.
−Removed: patent and patents that claim priority thereto, directed to mRNA capping technology to make and sell reagents and kits for research use only (excluding use in humans or for diagnostic or therapeutic purposes) in the United States.
−Removed: We are required to use commercially reasonable efforts to commercialize the licensed products throughout the life of the LSU Patent License Agreement.
−Removed: We are obligated to pay a low four-figure annual license maintenance fee and royalties in the range of 5% to 10% on net sales of licensed products.
−Removed: We must pay royalties to LSU until the expiration of the last to expire licensed patents.
−Removed: We are entitled to terminate the LSU Patent License Agreement for convenience at any time on at least sixty (60) days written notice, subject to paying in full all amounts due up to the date of termination and cessation of any exercise of the licensed rights thereafter.
−Removed: LSU may terminate the license for our uncured failure to make payments or our uncured material breach.
−Removed: AmberGen Agreement
−Removed: We (through Glen Research) entered into an Agreement with AmberGen, Inc.
−Removed: (“AmberGen”), dated May 11, 2000 (the “AmberGen Agreement”) under which AmberGen has appointed us the exclusive distributor of AmberGen’s proprietary photocleavable product offered under the name PC Phosphoramidite on a worldwide basis.
−Removed: We are limited to selling the product for research use only and are required to use good faith efforts to discontinue distribution to buyers making use of the product than purposes other than laboratory research.
−Removed: We are entitled under the AmberGen Agreement to purchase product from AmberGen at AmberGen’s cost to manufacture the product.
−Removed: On a monthly basis, we are required to remit to AmberGen 50% of the gross profits on product sales for which payments were received in the preceding month.
−Removed: The AmberGen Agreement was initially in effect for a five-year term but is now in a series of automatic one-year renewal terms.
−Removed: Either party may terminate the AmberGen Agreement on six (6) months written notice or immediately for material breach of the other party or, subject to a cure period, for certain bankruptcy-related events.
−Removed: BTI Biosearch Dyes Agreement
−Removed: We (through Glen Research) are a party to a Commercial Supply and License Agreement with Biosearch Technologies, Inc.
−Removed: (“BTI”), dated June 29, 2004, as amended on November 8, 2004 (the “BTI Biosearch Dyes Agreement”), under which BTI agrees to supply us with certain BTI dyes and we are granted a worldwide, non-exclusive license to sell certain BTI dyes and to use BTI’s product-related trademarks to do so.
−Removed: The BTI dyes can only be sold for the customer’s internal research and development use and inclusion in commercial kits or any commercial application is prohibited unless the customer has obtained a valid commercial license from BTI.
−Removed: The rights granted do not include sales to customers for use in human in vitro or clinical diagnosis.
−Removed: We are required to pay a per unit price for the licensed BTI products.
−Removed: 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.
−Removed: Either party has the right to opt-out of such renewals upon ninety (90) days’ notice prior to the next renewal.
−Removed: Either party can terminate the agreement for convenience at any time on six months’ written notice.
−Removed: Either party can terminate the agreement for the other party’s uncured material breach or insolvency.
Manufacturing and Supply
−Removed: We occupy facilities in San Diego, California, Southport, North Carolina and Sterling, Virginia.
+Added: 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.
−Removed: 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 8 and ISO 7 designated customer manufacturing suites and integrated building management systems for required site control.
−Removed: We continue to invest in our Wateridge 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.
−Removed: This investment has allowed us to substantially increase our capacity for nucleic acid production and specifically CleanCap meeting the demand from our customers without interruption or constraints.
−Removed: In addition to the Wateridge facility, throughout 2022 we invested in an additional facility in San Diego.
−Removed: California (the “Flanders San Diego Facility”) that we expect to occupy in 2023.
−Removed: The new Flanders San Diego Facility will provide us with additional GMP manufacturing capacity and provide us the optionality downstream to manufacture materials beyond current quality requirements for mRNA raw materials, including CleanCap.
−Removed: The Flanders San Diego Facility will include the introduction of integrated manufacturing systems, quality of 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.
−Removed: These investments will also support an additional increase to batch run sizes and overall throughput.
−Removed: In 2022, we secured additional office, warehouse and light lab space in San Diego for the primary purpose to relocate our sales, general and administrative employees.
−Removed: We also assumed a lease from our MyChem acquisition and have repurposed the facility as a small R&D lab.
−Removed: Our Southport, North Carolina operations are engaged in the manufacture and processing of antibody and HCP ELISA kits.
−Removed: The operations include laboratory, manufacturing, bottling, shipping and waste handling capabilities.
−Removed: In 2023, our Southport operations will relocate to a new state-of-the-art facility in Leland, North Carolina.
−Removed: This new facility more than doubles our operational square footage to support current and future growth.
−Removed: The fully customized design will provide room for a Mass Spectrometry Center of Excellence and specialized cell culture facilities.
−Removed: It will significantly increase our cold storage capacity while providing other R&D, laboratory and automation upgrades.
+Added: 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.
+Added: In addition to the Wateridge facility, we have two facilities in San Diego, Flanders 1 and Flanders 2.
+Added: Flanders 1 provides us with additional GMP manufacturing capacity and provides us the optionality downstream to manufacture materials beyond current quality requirements for mRNA raw materials, including CleanCap.
+Added: Flanders 1 will also support an additional increase to batch run sizes and overall throughput.
+Added: Flanders 2 was purpose built to support GMP-grade manufacturing and to support customers into Phase II clinical trials and beyond.
+Added: Both the Flanders 1 and Flanders 2 facilities include the introduction of integrated manufacturing systems, quality of 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.
+Added: We took occupancy of the Flanders facilities in 2023 and expect to begin manufacturing from both locations in 2024.
+Added: In early 2023, our Southport, North Carolina operations were relocated to a new state-of-the-art facility in Leland, North Carolina.
+Added: This new facility more than doubles our operational square footage and has capacity to support future growth in the manufacture and processing of antibody and HCP ELISA kits.
+Added: The operations include laboratory, manufacturing, kitting, cold storage, shipping and waste handling capabilities.
+Added: The fully customized design includes a Mass Spectrometry Center of Excellence and specialized cell culture facilities.
+Added: It significantly increases our manufacturing and development capacity while providing other R&D, laboratory and automation upgrades.
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.
−Removed: Our supply chain relies on a network of specialized suppliers and transportation companies.
−Removed: We regularly review our supply chain for supplier quality and risks related to concentration of supply and we take appropriate action to manage these potential risks.
+Added: Through our acquisition of Alphazyme in the first quarter of 2023, we acquired a purpose-built enzyme production facility in Jupiter, Florida, that can produce enzymes to kilogram quantities.
+Added: 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.
+Added: Our enzymes are produced under the controls of an ISO 13485:2016 compliant QMS.
+Added: 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.
+Added: These proactive evaluations enable us to implement strategic measures to effectively manage and mitigate risks.
+Added: By continuously optimizing our supply chain, we ensure operational resilience and maintain a steady supply of critical materials for our products.
Government Regulation
28 unchanged sentences
We do not make claims related to safety or effectiveness and they are not intended for diagnostic or clinical use.
−Removed: 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,
−Removed: development, manufacture, and distribution of our products.
+Added: 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.
20 unchanged sentences
To date, there have been no material effects upon our earnings or competitive position resulting from our compliance with applicable laws or regulations enacted or adopted relating to the protection of the environment.
−Removed: Our capital and operating expenditures for pollution control in 2022 and 2021 were not material.
+Added: Our capital and operating expenditures for pollution control in 2023 and 2022 were not material and are not expected to be material in 2024.
Intellectual Property
4 unchanged sentences
In addition, we protect our ongoing research and development into critical reagents for cell and gene therapy through patents and other intellectual property rights.
−Removed: 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.
+Added: Our patent portfolio generally includes patents and patent applications relating to compositions and methods for the production of CleanCap, oligonucleotides, nucleic acids, immunofluorescence assays, and mock viral particles.
We may own provisional patent applications, and provisional patent applications are not eligible to become issued patents until, among other things, we file national stage patent applications either directly or via the PCT within 12 or 30 to 32 months, respectively.
15 unchanged sentences
Compositions and methods for synthesizing 5′-Capped RNAs
+Added: United States 11878991
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
+Added: United States 11578095
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
Europe 3352584
Compositions and methods for synthesizing 5′-Capped RNAs
+Added: Europe 3954225
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
+Added: Europe 3906789
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
+Added: Europe 4104687
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
+Added: Europe 4140491
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
Australia 2016328645
Compositions and methods for synthesizing 5′-Capped RNAs
+Added: Australia 2021206780
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
+Added: ZL 202310734863.0
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
Japan 6814997
2 unchanged sentences
Compositions and methods for synthesizing 5′-Capped RNAs
+Added: Korea, Republic of
+Added: Compositions and methods for synthesizing 5′-Capped RNAs
The following patents relate to our MockV related products and technology.
7 unchanged sentences
Australia 2014320015 Methods and kits for quantifying the removal of Mock Virus Particles from a purified solution
+Added: Australia 2021200484
+Added: Methods and kits for quantifying the removal of Mock Virus Particles from a purified solution
China 105899684
2 unchanged sentences
Methods and kits for removal of mock virus particles from a purified solution
+Added: United States
+Added: Methods and kits for removal of mock virus particles from a purified solution
Our trademark portfolio is designed to protect the brands of our current and future products and includes U.S.
3 unchanged sentences
We have determined that certain technologies, such as the production of antibodies for biologics safety testing, are better kept as trade secrets, rather than pursuing patent protection.
−Removed: To prevent disclosure of trade secrets to others, it is our policy to enter into nondisclosure, invention assignment and confidentiality agreements with parties who have access to trade secrets, such as our employees, collaborators, outside scientific collaborators, consultants, advisors and other third parties.
+Added: To prevent disclosure of trade secrets to others, it is our policy to enter into nondisclosure, invention assignment and confidentiality agreements with parties who have access to trade secrets, such as our employees, collaborators, outside scientific collaborators, consultants, advisors
+Added: and other third parties.
These agreements also provide that all inventions resulting from work performed for us or relating to our business and conceived or completed during the period of employment or assignment, as applicable, are our exclusive property.
6 unchanged sentences
Furthermore, it may be difficult to protect our trade secrets.
−Removed: While we have confidence in the measures we take to protect and preserve our trade secrets, they may be inadequate and can be breached, and we may not have adequate
−Removed: remedies for violations of such measures.
+Added: While we have confidence in the measures we take to protect and preserve our trade secrets, they may be inadequate and can be breached, and we may not have adequate remedies for violations of such measures.
In addition, our trade secrets may otherwise become known or be independently discovered by competitors.
4 unchanged sentences
Human Capital Management:
−Removed: Operating a sustainable business begins with our people.
−Removed: As of December 31, 2022, we had over 610 full-time employees.
−Removed: Among our employees, 46% identified as female, 54% identified as male and 55% identified as ethnically or racially diverse.
−Removed: Approximately 18% of our employees have earned advanced degrees and all employees receive rigorous on the job training.
−Removed: None of our employees is represented by a labor union, and none of our employees has entered into a collective bargaining agreement with us.
−Removed: We offer a highly competitive compensation and benefits program to attract and retain top talent.
−Removed: We believe it is important for our employees to have an ownership stake in our company, so all eligible employees receive equity awards under our 2020 Omnibus Incentive Plan and have the opportunity to purchase stock at a discount under our 2020 Employee Stock Purchase Plan.
−Removed: At Maravai, our success hinges on our ability to attract, engage, develop and retain a talented and diverse team who share our core values and mission to enable the miracles of science.
−Removed: Our talented employees drive our mission and help shape our culture, which plays an invaluable role in our execution at all levels in our organization.
−Removed: Our culture reflects our shared core values which we believe contribute to our success and the continued growth of our organization.
−Removed: We use our core values in candidate screening and performance management to help reinforce their importance in our organization.
−Removed: Our mission and core values are coded into our culture and help guide our path forward.
−Removed: We define our company culture and guiding principles with a simple acronym for how we conduct ourselves and service our clients:
−Removed: • C onnected — believing in people, trust and collaboration.
−Removed: • O pen — embracing ideas and perspectives for better outcomes.
−Removed: • D riven — finding a better way, always.
−Removed: • E mpowered - valuing integrity and accountability in everything we do.
−Removed: Our human capital management strategy oversees culture, talent acquisition, compensation and benefits, employee engagement, training and development, health and wellness and diversity, equity and inclusion.
−Removed: In 2022, we made strategic advancements in each of these areas to help ensure our workforce is aligned with our mission and values.
−Removed: For example, we implemented a new global applicant tracking system that enables us to better organize, track and engage with candidates throughout the recruitment and hiring process.
−Removed: We also launched a comprehensive, five-day orientation program for new employees called “Foundations,” which includes informational sessions with leadership and more than twenty hours of self-directed training.
−Removed: As part of our efforts to enhance our company culture, we have dedicated personnel focused on our diversity, equity and inclusion strategy and launched our first employee resource group, Women in Leadership, and proud to have an executive leadership team that is 50% women.
−Removed: To improve the quality of our colleagues’ experience at Maravai, we measured various levels of engagement through a company-wide survey and received an average participation rate of 91%.
−Removed: We use the results from our survey to develop action plans that we can incorporate into our human capital management strategy.
−Removed: As a leading life sciences company.
−Removed: we are committed to the health, safety and well-being of our employees.
−Removed: 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.
−Removed: In 2022, we continued to strengthen our comprehensive environmental, health and safety management system, which includes an online incident reporting platform across all company sites.
−Removed: Additionally, we have implemented incident intervention services which include telemedicine for some of our locations.
−Removed: Through our employee assistance program, employees and their families are offered up to three sessions with licensed counseling professionals at no cost to the employee and have on-demand access to additional online resources.
+Added: Empowering Our Future
+Added: At Maravai, we understand that our strength lies in the expertise and commitment of our people.
+Added: As of December 31, 2023, our team had over 650 full-time employees.
+Added: Following the reduction in force, which was completed on January 5, 2024, we had approximately 570 full-time employees.
+Added: Our workforce represents a diversity of backgrounds, with 44% identifying as female, 56% as male, and 52% as ethnically or racially diverse as of December 31, 2023.
+Added: We take pride in the fact that, as of December 31, 2023, 24% of our team held advanced degrees, underscoring our emphasis on science and innovation.
+Added: Our compensation and comprehensive benefits packages are designed to attract and retain the talent we need to be competitive in the markets we serve.
+Added: Believing in the value of ownership, we extend equity awards to all full-time employees through our 2020 Omnibus Incentive Plan, alongside opportunities to participate in our 2020 Employee Stock Purchase Plan.
+Added: Our commitment to excellence ensures every employee receives thorough on-the-job training.
+Added: We also understand that great people managers are the key to enabling and unlocking the potential of our employees.
+Added: In 2023, we initiated a bi-monthly “Leading Together” people leader series with all levels of our people leaders to ensure they had the critical knowledge, perspective, and tools to develop their people and align their teams towards company goals and objectives.
+Added: We actively work to foster direct and open lines of communication between all levels of staff through our all-employee engagement survey, our quarterly all-employee town halls, management skip level meetings, and an emphasis on our core values (Connected, Open, Driven, and Empowered).
+Added: Our 2023 company-wide engagement survey reached a participation rate of 97% and all levels of leadership engage in action planning based on the results.
+Added: In 2023, all of our sites participated in process excellence initiatives and we launched “Find a Better Way Day” to highlight the efforts of our employees to drive quality and safety improvements and reduce cost.
+Added: As a leading life sciences company, we are committed to the health, safety and well-being of our employees.
+Added: All employees that could be exposed to potential hazards are required to complete annual health and safety training, including laboratory chemical safety, hazard communication and hazardous waste management trainings.
+Added: In 2023, we upgraded our electronic Safety Data Sheet (SDS) system to more readily provide chemical safety data electronically to employees and customers.
Available Information
Our website is located at www.maravai.com, and our investor relations website is located at investors.maravai.com.
−Removed: 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
−Removed: amendments to these reports, are available through our investor relations website, free of charge, after we file them with the SEC.
+Added: Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and any amendments to these reports, are available through our investor relations website, free of charge, as soon as reasonably practicable after we electronically file or furnish them with the SEC.
Our filings with the SEC are also available, free of charge, on the SEC's website at www.sec.gov.
We webcast via our investor relations website our earnings calls and certain events we participate in or host with members of the investment community.
−Removed: 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.
+Added: 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,
+Added: 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.