MARAVAI LIFESCIENCES HOLDINGS, INC.

Previous wording

•Natural disasters, geopolitical instability (including the ongoing military conflicts in Ukraine and the Middle East) and other catastrophic events.

Current wording

•Natural disasters, geopolitical instability and other catastrophic events.

Previous wording

We are dependent on the level of our customers’ spending on and demand for outsourced nucleic acid production and biologics safety testing products and services. A reduction in spending or change in spending priorities of our customers could significantly reduce demand for our products and services and could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.

Current wording

We are dependent on the level of our customers’ spending on and demand for outsourced nucleic acid and biologics safety testing products and services. A reduction in spending or change in spending priorities of our customers could significantly reduce demand for our TriLink and Cygnus products and services and could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.

Previous wording

Access to capital is critical to many of our customers’ ability to fund research and development, particularly early-stage biotechnology and pharmaceutical companies, and historically, these companies have funded their research and development activities by raising capital privately or in the equity markets. Past declines and uncertainties in the capital markets, including as a result of ongoing macroeconomic challenges during 2023 and into 2024, including elevated interest rates and volatile credit markets, limited access to capital and negatively affected companies’ ability to fund research and development efforts due to a considerable contraction in the level of investment in venture- and private equity-backed startup companies and funding for companies at all stages, particularly early- and late-stage companies. Notwithstanding ongoing liquidity challenges, global venture capital investment increased slightly in 2024, however, investments in information technology and artificial intelligence (“AI”) companies overshadowed other sector categories, with over twice the level of investment relative to the health and life sciences sector. Lower levels of venture capital investment in the health and life sciences sector, together with hesitancy about a broader economic recovery, including as a result of geopolitical instability and actual and potential shifts in U.S. and foreign trade, economic and other policies, has led certain of our customers to implement more stringent budgetary policies designed to conserve capital, which in turn, caused a reduction in research and development spending and a decline in further purchases of our products and services. We have no assurance as to whether, or when, such research and development spending may stabilize or increase, if at all. Further, if the funding of venture- and private equity-backed biotechnology and pharmaceutical companies remains weak or weakens further, the research and development budgets of our customers may be further reduced or eliminated altogether, which could impact future demand for our products and services.

Current wording

Access to capital is critical to many of our customers’ ability to fund research and development, particularly early-stage biotechnology and pharmaceutical companies, and historically, these companies have funded their research and development activities by raising capital privately or in the equity markets. Past declines and uncertainties in the capital markets, including as a result of ongoing macroeconomic challenges during 2023 and into 2024, including elevated interest rates and volatile credit markets, limited access to capital and negatively affected companies’ ability to fund research and development efforts due to a considerable contraction in the level of investment in venture- and private equity-backed startup companies and funding for companies at all stages, particularly early- and late-stage companies. Global venture capital investments in healthcare and biotech companies in 2025 increased slightly from 2024 amounts, however, investments in artificial intelligence (“AI”) companies still overshadowed other sector categories, with roughly three times the number of dollars invested in companies in AI-related fields relative to the healthcare and biotech sector. And while the total number of dollars invested in healthcare and biotech companies increased in 2025, the share of U.S. startup investment dollars going to biotech companies has hit the lowest level in roughly 20 years, with funding for early-stage biotech companies being particularly slow. This means that even if market interest in funding biotech companies rebounds, there will be a limited pipeline of companies ready to scale. Lower levels of venture capital investment in the healthcare and biotech sector, relative to other sectors, together with caution about the stability of the broader macroeconomic environment, including as a result of of geopolitical instability and actual and potential shifts in U.S. and foreign trade, economic and other policies, has led certain of our customers to implement more stringent budgetary policies designed to conserve capital, which in turn, caused a reduction in research and development spending and a decline in further purchases of our products and services. We have no assurance as to whether, or when, such research and development spending may stabilize or increase, if at all. Further, if the funding of venture- and private equity-backed biotechnology and pharmaceutical companies remains weak or weakens further, the research and development budgets of our customers may be further reduced or eliminated altogether, which could impact future demand for our products and services.

Previous wording

We have no control over the timing and volume of purchases by our customers. We estimate that revenue from high-volume sales of CleanCap® for commercial phase vaccine programs represented approximately 25.4%, 21.0% and 67.9% of our total revenues for the years ended December 31, 2024, 2023 and 2022, respectively. The amount, timing and durability of future high-volume CleanCap® orders have become increasingly difficult to forecast because historical customers for such orders have been unable or unwilling to provide visibility into their anticipated future needs and plans to purchase CleanCap®. As a result, our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our revenues and future operating results, and if high-volume orders for CleanCap® do not materialize in the future at similar or greater levels than they have in the past, our revenues and cash flows will significantly decrease which, in turn, could have a material adverse impact on our future operating results and financial condition.

Current wording

We have no control over the timing and volume of purchases by our customers. We estimate that revenue from high-volume sales of CleanCap® for commercial phase vaccine programs represented approximately 0.0%, 25.4% and 21.0% of our total revenues for the years ended December 31, 2025, 2024 and 2023, respectively. The amount, timing and durability of future high-volume CleanCap® orders have become increasingly difficult to forecast because historical customers for such orders have been unable or unwilling to provide visibility into their anticipated long-term future needs and plans to purchase CleanCap®. As a result, our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our revenues and future operating results, and if high-volume orders for CleanCap® do not materialize in the future at similar or greater levels than they have in the past, our revenues and cash flows will significantly decrease which, in turn, could have a material adverse impact on our future operating results and financial condition.

Previous wording

Certain of our products, including our proprietary CleanCap® analogs, are used by our customers in the production of commercial phase vaccines, notably COVID-19 vaccines. During each of the years ended December 31, 2022, 2021 and 2020, our results of operations and cash flows were significantly and positively impacted by high-volume sales of our proprietary CleanCap® analogs and highly modified RNA products, particularly mRNA, for commercial vaccines. However, as a result of the general decrease in market demand for COVID-19 related products and services, including the supply and manufacture of COVID-19 vaccines, and in particular, following the end of U.S. federal public health emergency declaration and World Health Organization declaration of the end of the pandemic in early May 2022, we experienced substantial declines in high-volume orders for CleanCap®. For the years ended December 31, 2024, 2023 and 2022, we estimate that revenue from high-volume sales of CleanCap® for commercial phase vaccine programs and related services represented approximately 25.4%, 21.0% and 67.9%, respectively, of our total revenues. We expect to experience further declines in high-volume sales of CleanCap® for the aforementioned reasons, as well as a result of unused inventory of our products that our customers have on hand, which are not indication-specific. We are currently unable to fully estimate the impact of this unused inventory on our future revenues, nor are we able to predict when or if our customers will resume purchasing CleanCap® analogs for commercial phase vaccine production, if at all. Our longer-term revenue prospects for high-volume CleanCap® orders are highly uncertain but are expected to remain substantially lower than pandemic highs. Additionally, the ongoing manufacture and supply of COVID-19 vaccines (including bivalent booster doses) by our customers is uncertain and subject to various political, social, economic, and regulatory factors that are outside of our control, including the emergence, duration and intensity of new virus variants; regional resurgences of the virus globally; the availability and administration of pediatric and booster vaccinations, vaccine supply constraints, vaccine hesitancy and the effectiveness of vaccines against new virus strains; competition faced by our customers from other COVID-19 vaccine manufacturers and the development and availability of antiviral therapeutic alternatives; political and social debate relating to the need for, efficacy of, or side effects related to one or more specific COVID-19 vaccines; the politicization of vaccinations and increase in vaccine skepticism; and the U.S. economy and global economy. As the supply and manufacture of COVID-19 vaccines by our customers slows, or becomes no longer necessary, including if COVID-19 vaccines by our customers’ competitors are determined or perceived to be more effective, we expect that demand for high-volume sales of CleanCap® will continue to sig…

Excerpt shortened here; the source contains the full paragraph.

Current wording

Certain of our products, including our proprietary CleanCap® analogs, are used by our customers in the production of commercial phase vaccines, notably COVID-19 vaccines. During each of the years ended December 31, 2022, 2021 and 2020, our results of operations and cash flows were significantly and positively impacted by high-volume sales of our proprietary CleanCap® analogs and highly modified RNA products, particularly mRNA, for commercial vaccines. However, as a result of the general decrease in market demand for COVID-19 related products and services, including the supply and manufacture of COVID-19 vaccines, and in particular, following the end of U.S. federal public health emergency declaration and World Health Organization declaration of the end of the pandemic in early May 2022, we experienced substantial declines in high-volume orders for CleanCap®. For the years ended December 31, 2025, 2024 and 2023, we estimate that revenue from high-volume sales of CleanCap® for commercial phase vaccine programs and related services represented approximately 0.0%, 25.4% and 21.0%, respectively, of our total revenues. We expect to experience unpredictable fluctuations in demand for high-volume sales of CleanCap® for the aforementioned reasons, as well as a result of any unused inventory of our products that our customers have on hand, which are not indication-specific. We are currently unable to fully estimate the impact of any unused inventory on our future revenues, nor are we able to accurately predict the timing or magnitude of customers’ future purchases of our CleanCap® analogs for commercial phase vaccine production. Our longer-term revenue prospects for high-volume CleanCap®orders are highly uncertain but are expected to be substantially lower than pandemic highs. Additionally, the ongoing manufacture and supply of COVID-19 vaccines (including bivalent booster doses) by our customers is uncertain and subject to various political, social, economic, and regulatory factors that are outside of our control, including the emergence, duration and intensity of new virus variants; regional resurgences of the virus globally; the availability and administration of pediatric and booster vaccinations, vaccine supply constraints, vaccine hesitancy and the effectiveness of vaccines against new virus strains; competition faced by our customers from other COVID-19 vaccine manufacturers and the development and availability of antiviral therapeutic alternatives; political and social debate relating to the need for, efficacy of, or side effects related to one or more specific COVID-19 vaccines; the politicization of vaccinations and increase in vaccine skepticism; and the U.S. economy and global economy. As the supply and manufacture of COVID-19 vaccines by our customers slows, or becomes no longer necessary, including if COVID-19 vaccines by our customers’ competitors are determined or perceived to be more effective, we expect that demand for high-volume sales o…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

Our reagents are sold primarily to biopharmaceutical and academic organizations developing novel vaccines and therapies and performing basic research. Research and development spending by our customers and the availability of government research funding can fluctuate due to changes in available resources, institutional and governmental budgetary policies, mergers of pharmaceutical and biotechnology companies, spending priorities, and general economic conditions. Our biologics safety testing customers are biopharmaceutical companies, contract research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”) and life science companies, which largely serve the biopharmaceutical industry. Our nucleic acid production customers are largely vaccine and therapeutic drug makers or diagnostics manufacturers, which rely in part on government healthcare-related policies and funding. As a result, changes in government funding for certain research, decreases in or the imposition of limits on government spending more generally (including if the Office of Management and Budget reenacts its call for a freeze on payments for federal grants), skepticism of or hostility to mRNA as a modality, or reductions in overall healthcare spending could negatively impact us or our customers and, correspondingly, our sales to them, which would negatively affect our business, operations and financial condition.

Current wording

Our reagents are sold primarily to biopharmaceutical and academic organizations developing novel vaccines and therapies and performing basic research. Research and development spending by our customers and the availability of government research funding can fluctuate due to changes in available resources, institutional and governmental budgetary policies, mergers of pharmaceutical and biotechnology companies, spending priorities, and general economic conditions. Our Cygnus customers are biopharmaceutical companies, contract research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”) and life science companies, which largely serve the biopharmaceutical industry. Our TriLink customers are largely vaccine and therapeutic drug makers or diagnostics manufacturers, which rely in part on government healthcare-related policies and funding. As a result, changes in government funding for certain research, decreases in or the imposition of limits on government spending more generally, skepticism of or hostility to mRNA as a modality, or reductions in overall healthcare spending could negatively impact us or our customers and, correspondingly, our sales to them, which would negatively affect our business, operations and financial condition.

Previous wording

We are subject to the risk of disruption by earthquakes, hurricanes, floods and other natural disasters, fire, power shortages, geopolitical unrest, war (including any escalation of the ongoing military conflicts in Ukraine or the Middle East), terrorist attacks and other hostile acts, public health issues, epidemics or pandemics and other events beyond our control and the control of the third parties on which we depend. Any of these catastrophic events, whether in the United States or abroad, may have a significant negative impact on the global economy, our employees, facilities, partners, suppliers, distributors or customers, and could decrease demand for our products and services, create delays and inefficiencies in our supply chain and make it difficult or impossible for us to deliver products and services to our customers.

Current wording

We are subject to the risk of disruption by earthquakes, hurricanes, floods and other natural disasters, fire, power shortages, geopolitical unrest, war (including any escalation of the ongoing military conflicts in Venezuela, Ukraine or the Middle East), terrorist attacks and other hostile acts, public health issues, epidemics or pandemics and other events beyond our control and the control of the third parties on which we depend. Any of these catastrophic events, whether in the United States or abroad, may have a significant negative impact on the global economy, our employees, facilities, partners, suppliers, distributors or customers, and could decrease demand for our products and services, create delays and inefficiencies in our supply chain and make it difficult or impossible for us to deliver products and services to our customers.

Previous wording

We plan to continue a strategy of growth and development for our business. To this end, we actively evaluate various strategic transactions on an ongoing basis, including licensing or acquiring complementary products, technologies or businesses that would complement our existing portfolio of products and services. In order to complete such strategic transactions, we may need to seek additional financing to fund these investments and acquisitions. Should we need to do so, we may not be able to secure such financing, or obtain such financing on favorable terms, for reasons including rising interest rates and continued volatility and uncertainty in the U.S. and global capital and credit markets. Our credit agreement also contains a number of restrictive covenants that impose significant restrictions on our ability to make acquisitions or certain other investments, as well as to incur additional indebtedness to finance such acquisitions or other investments. In addition, future acquisitions may require the issuance or sale of additional equity, or equity-linked securities, which may result in additional dilution to our shareholders.

Current wording

We plan to continue a strategy of growth and development for our business. To this end, we actively evaluate various strategic transactions on an ongoing basis, including licensing or acquiring complementary products, technologies or businesses that would complement our existing portfolio of products and services. In order to complete such strategic transactions, we may need to seek additional financing to fund these investments and acquisitions. Should we need to do so, we may not be able to secure such financing, or obtain such financing on favorable terms, for reasons including the impact of geopolitical or macroeconomic factors on the relative strength of the U.S. and global capital and credit markets. Our credit agreement also contains a number of restrictive covenants that impose significant restrictions on our ability to make acquisitions or certain other investments, as well as to incur additional indebtedness to finance such acquisitions or other investments. In addition, future acquisitions may require the issuance or sale of additional equity, or equity-linked securities, which may result in additional dilution to our shareholders.

Previous wording

We may be unable to efficiently manage growth opportunities as a larger and more geographically diverse organization.

Current wording

We may be unable to efficiently manage growth opportunities as a more geographically diverse organization.

Previous wording

Our strategic acquisitions, the continued expansion of our commercial sales operations and our organic growth opportunities have increased the scope and complexity of our business. As a result, we will face challenges inherent in efficiently managing a more complex business with an increased number of employees over large geographic distances, including the need to implement appropriate systems, policies, benefits and compliance programs. Our inability to manage successfully a geographically more diverse and substantially larger organization could materially adversely affect our operating results.

Current wording

Our strategic acquisitions and our organic growth opportunities have increased the scope and complexity of our business. As a result, we will face challenges inherent in efficiently managing a more complex business with our employee base spread over a larger geographic distance, including the need to implement appropriate systems, policies, benefits and compliance programs. Our inability to manage successfully a geographically more diverse organization could materially adversely affect our operating results.

Previous wording

We have made in the past, and may make in the future, selected opportunistic acquisitions of complementary businesses, products, services or technologies. In January 2023, we completed the acquisition of Alphazyme, LLC, an original equipment manufacturer provider of custom molecular biology enzymes, servicing customers in the genetic analysis and nucleic acid synthesis markets to complement our nucleic acid production business, in January 2025, we acquired the intellectual property and related assets of Molecular Assemblies, Inc., developers of enzymatic DNA synthesis technology to complement our nucleic acid production business, and in February 2025, we completed the acquisition of Officinae Bio, S.R.L., a technology company with a proprietary digital platform designed with AI and machine learning capabilities to support the biological design of therapeutics to complement our nucleic acid production business. However, we may be unable to continue to identify or complete promising acquisitions for many reasons, including competition among buyers, the high valuations of businesses in our industry, the need for regulatory and other approvals and the availability of capital, particularly during a period of disruption and volatility within the global capital and credit markets.

Current wording

We have made in the past, and may make in the future, selected opportunistic acquisitions of complementary businesses, products, services or technologies. In January 2025, we acquired the intellectual property and related assets of Molecular Assemblies, Inc., developers of enzymatic DNA synthesis technology to complement our TriLink business, and in February 2025, we completed the acquisition of Officinae Bio, S.R.L., a technology company with a proprietary digital platform designed with AI and machine learning capabilities to support the biological design of therapeutics to complement our TriLink business. However, we may be unable to continue to identify or complete promising acquisitions for many reasons, including competition among buyers, the high valuations of businesses in our industry, the need for regulatory and other approvals and the availability of capital, particularly during a period of disruption and volatility within the global capital and credit markets.

Previous wording

We are required under U.S. generally accepted accounting principles (“GAAP”) to test goodwill for impairment at least annually and to review our goodwill, amortizable intangible assets and other assets acquired through merger and acquisition activity for impairment when events or changes in circumstance indicate the carrying value may not be recoverable. In assessing fair value, we make estimates and assumptions about sales, operating margins, growth rates, and discount rates based on our business plans, economic projections, anticipated future cash flows and marketplace data. There are inherent uncertainties related to these factors and management’s judgment in applying these factors. Factors that could lead to impairment of goodwill, amortizable intangible assets and other assets acquired via acquisitions include significant adverse changes in the business climate and actual or projected operating results (affecting our company as a whole or affecting any particular segment) and declines in the financial condition of our business. For example, in connection with preparing our financial statements for the quarter ended September 30, 2024 and December 31, 2024, we identified certain indicators of impairment and recorded a goodwill impairment of $154.2 million related to the TriLink reporting unit and of $11.9 million related to the Alphazyme reporting unit, respectively, both within our nucleic acid production segment.

Current wording

We are required under U.S. generally accepted accounting principles (“GAAP”) to test goodwill for impairment at least annually and to review our goodwill, amortizable intangible assets and other assets acquired through merger and acquisition activity for impairment when events or changes in circumstance indicate the carrying value may not be recoverable. In assessing fair value, we make estimates and assumptions about sales, operating margins, growth rates, and discount rates based on our business plans, economic projections, anticipated future cash flows and marketplace data. There are inherent uncertainties related to these factors and management’s judgment in applying these factors. Factors that could lead to impairment of goodwill, amortizable intangible assets and other assets acquired via acquisitions include significant adverse changes in the business climate and actual or projected operating results (affecting our company as a whole or affecting any particular segment) and declines in the financial condition of our business. For example, in connection with preparing our financial statements for the quarters ended March 31, 2025 and June 30, 2025, and the year ended December 31, 2025, we identified certain indicators of impairment and recorded a goodwill impairment of $12.4 million related to the TriLink BioTechnologies reporting unit, $30.4 million related to the Alphazyme reporting unit, and intangible asset impairment of $27.8 million primarily related to the Alphazyme asset group, all within our TriLink segment.

Previous wording

Revenue from our largest customers were 20.8%, 19.3% and 61.2% of total revenue for the years ended December 31, 2024, 2023 and 2022, respectively. The revenue attributable to our top customers has fluctuated in the past and may fluctuate in the future, which could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects. In addition, the termination of these relationships, including following any failure to renew a long-term contract, could result in a temporary or permanent loss of revenue. See also “—The extent and duration of our revenue associated with high-volume sales of CleanCap® for commercial phase vaccine programs is uncertain and are dependent, in important respects, on factors outside our control.”

Current wording

While we had no single customer that accounted for more than 10% of our total revenue for the year ended December 31, 2025, revenue from our largest customers were 20.8% and 19.3% of total revenue for the years ended December 31, 2024 and 2023, respectively. The revenue attributable to our top customers has fluctuated in the past and may fluctuate in the future, which could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects. In addition, the termination of these relationships, including following any failure to renew a long-term contract, could result in a temporary or permanent loss of revenue. See also “—The extent and duration of our revenue associated with high-volume sales of CleanCap® for commercial phase vaccine programs is uncertain and are dependent, in important respects, on factors outside our control.”

Previous wording

We rely on certain distributors in order to market and sell ourproducts and services in in certain international markets, particularly our biologics safety testing products and services in China. Our distributor in China accounted for 4.6% of our total revenues in the year ended December 31, 2024. If we are unable to maintain this distributor or enter into a similar arrangement with another distributor, or our current or future distributors do not perform adequately, our revenues and results of operations would likely be adversely impacted, at least temporarily. Additionally, changes in the inventory levels of our products owned and held by our distributors can result in significant variability in our revenues. Furthermore, our revenues from such distributors could be negatively impacted by macroeconomic conditions specific to the geographic markets in which our products and services are marketed and sold, geopolitical risks and other risks described below under “We are subject to financial, operating, legal and compliance risks associated with global operations.”

Current wording

We rely on certain distributors in order to market and sell ourproducts and services in certain international markets. If we are unable to maintain these distributors or enter into similar arrangements with other distributors, or our current or future distributors do not perform adequately, our revenues and results of operations would likely be adversely impacted, at least temporarily. Additionally, changes in the inventory levels of our products owned and held by our distributors can result in significant variability in our revenues. Furthermore, our revenues from such distributors could be negatively impacted by macroeconomic conditions specific to the geographic markets in which our products and services are marketed and sold, geopolitical risks and other risks described below under “We are subject to financial, operating, legal and compliance risks associated with global operations.”

Previous wording

Certain of our raw materials are sourced from a limited number of suppliers and some materials, including a proprietary DNA reagent, certain packaging materials, specific cell lines for Cygnus Technologies’ operations and certain raw materials used in our nucleic acid production products, as well as those raw materials sold under the Glen Research brand, are sole sourced. Delays or difficulties in securing these raw materials or other laboratory materials could result in an interruption in our production operations if we cannot obtain an acceptable substitute. In recent years, global supply chains have faced challenges, including material availability, global logistics delays and constraints arising from, among other things, the transportation capacity of ocean shipping containers. More recently, geopolitical instability and U.S. foreign trade policy, including the imposition or threatened imposition of tariffs or other trade restrictions, could increase macroeconomic uncertainty at a global level and lead to supply chain constraints and delays. Any interruption of our supply chain could significantly affect our business, financial condition, results of operations, cash flows and prospects. While we may identify other suppliers, raw materials furnished by such replacement suppliers may require us to alter our production operations or perform extensive validations, which may be time consuming and expensive. There can be no assurance that we will be able to secure alternative materials and revalidate them without experiencing interruptions in our workflow. If we should encounter delays or difficulties in obtaining raw materials, our business, financial condition, results of operations, cash flows and prospects could be adversely affected.

Current wording

Certain of our raw materials are sourced from a limited number of suppliers and some materials, including a proprietary DNA reagent, certain packaging materials, specific cell lines for Cygnus operations and certain raw materials used in our TriLink products, as well as those raw materials sold under the Glen Research brand, are sole sourced. Delays or difficulties in securing these raw materials or other laboratory materials could result in an interruption in our production operations if we cannot obtain an acceptable substitute. In recent years, global supply chains have faced challenges, including material availability, global logistics delays and constraints arising from, among other things, the transportation capacity of ocean shipping containers. More recently, geopolitical instability and U.S. foreign trade policy, including the imposition or threatened imposition of tariffs or other trade restrictions, could increase macroeconomic uncertainty at a global level and lead to supply chain constraints and delays. Any interruption of our supply chain could significantly affect our business, financial condition, results of operations, cash flows and prospects. While we may identify other suppliers, raw materials furnished by such replacement suppliers may require us to alter our production operations or perform extensive validations, which may be time consuming and expensive. There can be no assurance that we will be able to secure alternative materials and revalidate them without experiencing interruptions in our workflow. If we should encounter delays or difficulties in obtaining raw materials, our business, financial condition, results of operations, cash flows and prospects could be adversely affected.

Previous wording

We make certain of our products available to customers as research-use-only (“RUO”) products. RUO products are regulated by the FDA as medical devices, and includein vitro diagnostic products in the laboratory research phase of development that are being shipped or delivered for an investigation that is not subject to the FDA’s investigational device exemption requirements. Although medical devices are subject to stringent FDA oversight, products that are intended for RUO and are labeled as RUO are exempt from compliance with most FDA requirements, including premarket clearance or approval, manufacturing requirements, and others. A product labeled RUO but which is actually intended for clinical diagnostic use may be viewed by the FDA as adulterated and misbranded under the FDCA, and subject to FDA enforcement action. The FDA has indicated that when determining the intended use of a product labeled RUO, the FDA will consider the totality of the circumstances surrounding distribution and use of the product, including how the product is marketed and to whom. The FDA could disagree with our assessment that our products are properly marketed as RUO, or could conclude that products labeled as RUO are actually intended for clinical diagnostic use, and could take enforcement action against us, including requiring us to stop distribution of our products until we are in compliance with applicable regulations, which would reduce our revenue, increase our costs and adversely affect our business, prospects, results of operations and financial condition. In the event that the FDA requires us to obtain marketing authorization of our RUO products in the future, there can be no assurance that the FDA will grant any clearance or approval requested by us in a timely manner, or at all.

Current wording

We make certain of our products available to customers as RUO products. RUO products are regulated by the FDA as medical devices, and includein vitro diagnostic products in the laboratory research phase of development that are being shipped or delivered for an investigation that is not subject to the FDA’s investigational device exemption requirements. Although medical devices are subject to stringent FDA oversight, products that are intended for RUO and are labeled as RUO are exempt from compliance with most FDA requirements, including premarket clearance or approval, manufacturing requirements, and others. A product labeled RUO but which is actually intended for clinical diagnostic use may be viewed by the FDA as adulterated and misbranded under the FDCA, and subject to FDA enforcement action. The FDA has indicated that when determining the intended use of a product labeled RUO, the FDA will consider the totality of the circumstances surrounding distribution and use of the product, including how the product is marketed and to whom. The FDA could disagree with our assessment that our products are properly marketed as RUO, or could conclude that products labeled as RUO are actually intended for clinical diagnostic use, and could take enforcement action against us, including requiring us to stop distribution of our products until we are in compliance with applicable regulations, which would reduce our revenue, increase our costs and adversely affect our business, prospects, results of operations and financial condition. In the event that the FDA requires us to obtain marketing authorization of our RUO products in the future, there can be no assurance that the FDA will grant any clearance or approval requested by us in a timely manner, or at all.

Previous wording

We engage in business globally, with approximately 51%, 51% and 62% of our revenue for the years ended December 31, 2024, 2023 and 2022, respectively, coming from outside the U.S. In addition, one of our strategies is to expand geographically, both through distribution and through direct sales. This subjects us to a number of risks, including international economic, geopolitical, and labor conditions; currency fluctuations; tax laws (including U.S. taxes on income earned by foreign subsidiaries); increased financial accounting and reporting burdens and complexities; unexpected changes in, or impositions of, legislative or regulatory requirements; failure of laws to protect intellectual property rights adequately; inadequate local infrastructure and difficulties in managing and staffing international operations; delays resulting from difficulty in obtaining export licenses for certain technology; new or increased tariffs (or potential retaliatory actions taken in response thereto), quotas and other trade barriers and restrictions; transportation delays; operating in locations with a higher incidence of corruption and fraudulent business practices; and other factors beyond our control, including terrorism, war, natural disasters, climate change and diseases.

Current wording

We engage in business globally, with approximately 40%, 51% and 51% of our revenue for the years ended December 31, 2025, 2024 and 2023, respectively, coming from outside the U.S. In addition, one of our strategies is to expand geographically, both through distribution and through direct sales. This subjects us to a number of risks, including international economic, geopolitical, and labor conditions; currency fluctuations; tax laws (including U.S. taxes on income earned by foreign subsidiaries); increased financial accounting and reporting burdens and complexities; unexpected changes in, or impositions of, legislative or regulatory requirements; failure of laws to protect intellectual property rights adequately; inadequate local infrastructure and difficulties in managing and staffing international operations; delays resulting from difficulty in obtaining export licenses for certain technology; new or increased tariffs (or potential retaliatory actions taken in response thereto), quotas and other trade barriers and restrictions; transportation delays; operating in locations with a higher incidence of corruption and fraudulent business practices; and other factors beyond our control, including terrorism, war, natural disasters, climate change and diseases.

Previous wording

Companies across all industries and around the globe are facing increasing scrutiny relating to their ESG policies, initiatives and activities by investors, lenders, customers, government regulators and other market participants. More recently, certain ESG policies, initiatives and activities have become politicized, with ideologically opposing perspectives, such that companies may find themselves unable to satisfactorily consider or address one stakeholder’s concerns without creating concerns among another set of stakeholders with an opposing viewpoint. If we are unable to meet our ESG initiatives or evolving investor, industry, or customer expectations and standards, we are perceived to have not responded adequately on any number of ESG matters, or we draw scrutiny from certain people or groups with an opposing viewpoint, we risk damage to our brand and reputation, adverse impacts to our ability to secure government contracts, decreased desirability of our common stock to investors, or limited access to capital markets and other sources of financing..

Current wording

Companies across all industries and around the globe are facing increasing scrutiny relating to their ESG policies, initiatives and activities by investors, lenders, customers, government regulators and other market participants. More recently, certain ESG policies, initiatives and activities have become politicized, with ideologically opposing perspectives, such that companies may find themselves unable to satisfactorily consider or address one stakeholder’s concerns without creating concerns among another set of stakeholders with an opposing viewpoint. If we are unable to meet evolving investor, industry, or customer expectations and standards with respect to their ESG-related expectations and requirements, we are perceived to have not responded adequately on any number of ESG matters, or we draw scrutiny from certain people or groups with an opposing viewpoint, we risk damage to our brand and reputation, adverse impacts to our ability to secure customer contracts, decreased desirability of our common stock to certain investors, or limited access to capital markets and other sources of financing.

Previous wording

There is no guarantee that any ESG or sustainability goals set forth in our ESG initiatives will be achieved on the desired timeframe or at all, and the achievement of any such goals may require the incurrence of additional costs or the implementation of operational changes, any of which could adversely affect the Company’s results of operations.

Current wording

There is no guarantee that any sustainability goals set forth in our sustainability initiatives will be achieved on the desired timeframe or at all, and the achievement of any such goals may require the incurrence of additional costs or the implementation of operational changes, any of which could adversely affect the Company’s results of operations.

Previous wording

As of December 31, 2024, we had total current and long-term indebtedness outstanding of approximately $295.9 million, including term loans of $299.7 million less unamortized debt issuance costs of $3.8 million. We may incur significant additional indebtedness in the future. If we increase our current indebtedness levels, the risks related to our indebtedness as set forth herein could intensify.

Current wording

As of December 31, 2025, we had total current and long-term indebtedness outstanding of approximately $291.8 million, including term loans of $294.2 million less unamortized debt issuance costs of $2.5 million. We may incur significant additional indebtedness in the future. If we increase our current indebtedness levels, the risks related to our indebtedness as set forth herein could intensify.

Previous wording

Receivable Agreement. Any payments made by us to MLSH 1 and MLSH 2 under the Tax Receivable Agreement will generally reduce the amount of overall cash flow that might have otherwise been available to us. To the extent that we are unable to make payments under the Tax Receivable Agreement, such payments generally will be deferred and will accrue interest until paid. Nonpayment for a specified period, however, may constitute a breach of a material obligation under the Tax Receivable Agreement and therefore accelerate payments due under the Tax Receivable Agreement, unless, generally, such nonpayment is due to a lack of sufficient funds. Furthermore, our future obligation to make payments under the Tax Receivable Agreement could make us a less attractive target for an acquisition, particularly in the case of an acquirer that cannot use some or all of the tax benefits that may be deemed realized under the Tax Receivable Agreement. The payments under the Tax Receivable Agreement are also not conditioned upon MLSH 1 maintaining a continued ownership interest in Topco LLC.

Current wording

Pursuant to the Tax Receivable Agreement we are required to make cash payments to MLSH 1 and MLSH 2, collectively, equal to 85% of the tax benefits, if any, that we actually realize, or, in some circumstances, are deemed to realize, as a result of (i) certain increases in the tax basis of assets of Topco LLC and its subsidiaries resulting from purchases or exchanges of LLC Units, (ii) certain tax attributes related to the LLC Units held by the corporations that merged into our corporate structure as part of the Organizational Transactions (as discussed in Note 11 to our consolidated financial statements), Topco LLC and subsidiaries of Topco LLC that existed prior to our initial public offering and (iii) certain other tax benefits related to our entering into the Tax Receivable Agreement, including tax benefits attributable to payments that we make under the Tax Receivable Agreement. Any payments made by us to MLSH 1 and MLSH 2 under the Tax Receivable Agreement will generally reduce the amount of overall cash flow that might have otherwise been available to us. To the extent that we are unable to make payments under the Tax Receivable Agreement, such payments generally will be deferred and will accrue interest until paid. Nonpayment for a specified period, however, may constitute a breach of a material obligation under the Tax Receivable Agreement and therefore accelerate payments due under the Tax Receivable Agreement, unless, generally, such nonpayment is due to a lack of sufficient funds. Furthermore, our future obligation to make payments under the Tax Receivable Agreement could make us a less attractive target for an acquisition, particularly in the case of an acquirer that cannot use some or all of the tax benefits that may be deemed realized under the Tax Receivable Agreement. The payments under the Tax Receivable Agreement are also not conditioned upon MLSH 1 maintaining a continued ownership interest in Topco LLC.

Previous wording

As discussed in Note 18 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we determined that our unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2024 and the three and nine months ended September 30, 2024 required restatement primarily to correct an error we identified relating to the timing of revenue recognition for a product sale with non-standard contractual terms. Assessment of the error and the effectiveness of the Company’s disclosure controls and procedures and its internal control over financial reporting, the resulting restatement of our unaudited condensed consolidated financial statements for the impacted periods, and the ongoing process of remediating the material weaknesses in our internal control over financial reporting have diverted management’s attention and caused us to incur unanticipated expenses for legal, audit and other professional services fees. The restatement and the associated non-reliance on our previously issued quarterly financial statements and other related financial information could also cause investors to lose confidence in our financial reporting and harm our reputation, which in turn, could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects. We are currently subject to a putative securities class action lawsuit, and face the potential for additional, litigation or regulatory inquiries in connection with or related to the restatement and associated material weaknesses, including claims involving the U.S. federal securities laws. Litigation and any regulatory inquiries are likely to divert management’s time and attention and, regardless of the outcome of such litigation, we will incur legal and other costs of defense, which could be significant. Further, if we do not prevail in the litigation, we could be required to pay substantial damages or settlement costs, which could have a material adverse effect on our financial condition, results of operations and cash flows.

Current wording

As discussed in Note 18 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024, we determined that our unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2024 and the three and nine months ended September 30, 2024 required restatement primarily to correct an error we identified relating to the timing of revenue recognition for a product sale with non-standard contractual terms. Assessment of the error and the effectiveness of the Company’s disclosure controls and procedures and its internal control over financial reporting, the resulting restatement of our unaudited condensed consolidated financial statements for the impacted periods, the related securities litigation, and remediating the material weaknesses in our internal control over financial reporting diverted management’s attention and caused us to incur significant unanticipated expenses for legal, audit and other professional services fees. The restatement and the associated non-reliance on our previously issued quarterly financial statements and other related financial information could also cause investors to lose confidence in our financial reporting and harm our reputation, which in turn, could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.

Previous wording

As noted above and further disclosed in Part II, Item 9A, “Controls and Procedures” of this Annual Report, we identified material weaknesses in our internal control over financial reporting as of December 31, 2024,and as a result, our management concluded that our disclosure controls and procedures and internal control over financial reporting were not effective as of December 31, 2024. While we are actively engaged in the process of designing appropriate controls to address these material weaknesses, there can be no assurance that the actions will fully remediate the material weaknesses in a timely manner or that there will not be additional material weaknesses in our internal control over financial reporting in the future. If we are unable to remediate the identified material weaknesses in a timely manner, or at all, or are otherwise unable to maintain effective internal control over financial reporting in the future, our ability to record, process and report financial information accurately, and to comply with our financial reporting obligations, could be adversely impacted.

Current wording

As further disclosed in Part II, Item 9A, “Controls and Procedures” of our Annual Report on Form 10-K for the year ended December 31, 2024, we identified material weaknesses in our internal control over financial reporting as of December 31, 2024, and as a result, our management concluded that our disclosure controls and procedures and internal control over financial reporting were not effective as of December 31, 2024. During the year ended December 31, 2025, under the oversight of the Audit Committee of our Board of Directors, we completed the implementation of our remediation plan and enhanced the design and operation of controls to address the previously identified material weaknesses. The applicable controls have been in place for a sufficient period of time and management has concluded, through testing, that the controls operated effectively and the material weaknesses described above have been remediated. However, there can be no assurance that we will not identify additional material weaknesses or significant deficiencies in the future. If we identify additional material weaknesses or significant deficiencies in the future, or are otherwise unable to maintain effective internal control over financial reporting in the future, our ability to record, process and report financial information accurately, and to comply with our financial reporting obligations, could be adversely impacted.

Previous wording

As of December 31, 2024, investment entities affiliated with GTCR collectively controlled approximately 52% of the voting power of our outstanding common stock and therefore GTCR controls the outcome of all matters submitted to a vote of our shareholders. This control enables GTCR to control the election of the members of the Board and all other corporate decisions. Even when GTCR ceases to control a majority of the total voting power, for so long as GTCR continues to own a significant percentage of our Class A common stock, GTCR will still be able to significantly influence the composition of our Board and the approval of actions requiring shareholder approval. Accordingly, for such period of time, GTCR will have significant influence with respect to our management, business plans and policies, including the appointment and removal of our officers, decisions on whether to raise future capital and amending our charter and bylaws, which govern the rights attached to our Class A common stock. In particular, for so long as GTCR continues to own a significant percentage of our Class A common stock, GTCR will be able to cause or prevent a change of control of us or a change in the composition of our Board and could preclude any unsolicited acquisition of us. The concentration of ownership could deprive you of an opportunity to receive a premium for your shares of Class A common stock as part of a sale of us and ultimately might affect the market price of our Class A common stock.

Current wording

As of December 31, 2025, investment entities affiliated with GTCR collectively controlled approximately 51% of the voting power of our outstanding common stock and therefore GTCR controls the outcome of all matters submitted to a vote of our shareholders. This control enables GTCR to control the election of the members of the Board and all other corporate decisions. Even when GTCR ceases to control a majority of the total voting power, for so long as GTCR continues to own a significant percentage of our Class A common stock, GTCR will still be able to significantly influence the composition of our Board and the approval of actions requiring shareholder approval. Accordingly, for such period of time, GTCR will have significant influence with respect to our management, business plans and policies, including the appointment and removal of our officers, decisions on whether to raise future capital and amending our charter and bylaws, which govern the rights attached to our Class A common stock. In particular, for so long as GTCR continues to own a significant percentage of our Class A common stock, GTCR will be able to cause or prevent a change of control of us or a change in the composition of our Board and could preclude any unsolicited acquisition of us. The concentration of ownership could deprive you of an opportunity to receive a premium for your shares of Class A common stock as part of a sale of us and ultimately might affect the market price of our Class A common stock.

Previous wording

Sales of a substantial number of shares of our Class A common stock in the public market could occur at any time. As of December 31, 2024, we had 141,976,348 outstanding shares of Class A common stock, 20,150,005 of which were held by MLSH 2, and further, as of December 31, 2024, an additional 110,684,080 shares of Class A common stock are issuable upon the exchange by MLSH 1 of its interest in Topco. Because each of MLSH 1 and MLSH 2 is controlled by GTCR and is considered an “affiliate” of ours, the shares of Class A common stock held by MLSH 1 and MLSH 2 are subject to certain restrictions on resale imposed by U.S. federal securities laws. However, pursuant to a registration rights agreement, MLSH 1 and MLSH 2 have the right to request that we register these shares in which case the shares would be able to be freely sold in the public market without such restrictions. These sales, or the perception in the market that the holders of a large number of shares of Class A common stock intend to sell shares, could reduce the market price of our Class A common stock.

Current wording

Sales of a substantial number of shares of our Class A common stock in the public market could occur at any time. As of December 31, 2025, we had 145,324,017 outstanding shares of Class A common stock, 20,150,005 of which were held by MLSH 2, and further, as of December 31, 2025, an additional 110,684,080 shares of Class A common stock are issuable upon the exchange by MLSH 1 of its interest in Topco. Because each of MLSH 1 and MLSH 2 is controlled by GTCR and is considered an “affiliate” of ours, the shares of Class A common stock held by MLSH 1 and MLSH 2 are subject to certain restrictions on resale imposed by U.S. federal securities laws. However, pursuant to a registration rights agreement, MLSH 1 and MLSH 2 have the right to request that we register these shares in which case the shares would be able to be freely sold in the public market without such restrictions. These sales, or the perception in the market that the holders of a large number of shares of Class A common stock intend to sell shares, could reduce the market price of our Class A common stock.