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Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us.
−Removed: You should carefully consider the risks described below, together with the financial and other information contained in this Annual Report on Form 10-K.
If any of the following risks occur, our business, financial condition, results of operations and prospects could be materially and adversely affected.
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Summary of Risk Factors
−Removed: The following is a summary of the risk factors our business faces.
−Removed: The list below is not exhaustive, and investors should read this “Risk Factors” section in full.
−Removed: • The extent and duration of our revenue associated with COVID-19-related products and services are uncertain and are dependent, in important respects, on factors outside our control.
−Removed: • Changes in economic conditions could negatively impact our revenue and earnings.
−Removed: • Certain of our products are used by customers in the production of vaccines and therapies, some of which represent relatively new and still-developing modes of treatment.
−Removed: Unforeseen adverse events, negative clinical outcomes, development of alternative therapies, or increased regulatory scrutiny of these and their financial cost may damage public perception of the safety, utility, or efficacy of these vaccines and therapies or other modes of treatment and may harm our customers’ ability to conduct their business.
−Removed: Such events may negatively impact our revenue and have an adverse effect on our performance.
−Removed: • We are dependent on our customers’ spending on and demand for outsourced nucleic acid production and biologics safety testing products and services.
−Removed: A reduction in spending or demand could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.
−Removed: • We compete with life science, pharmaceutical and biotechnology companies who are substantially larger than we are and potentially capable of developing new approaches that could make our products, services and technology obsolete.
−Removed: • If our products and services do not perform as expected or the reliability of the technology on which our products and services are based in questioned, we could experience lost revenue, delayed or reduced market acceptance of our products and services, increased costs and damage to our reputation.
−Removed: • Our products are highly complex and are subject to quality control requirements.
−Removed: • Our commercial success depends on the market acceptance of our life science reagents.
−Removed: Our reagents may not achieve or maintain significant commercial market acceptance.
−Removed: • Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
−Removed: • Ongoing geopolitical instability and the resulting economic disruption may negatively impact our business, operations and financial condition.
−Removed: • Product liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing products and limit commercialization of any products that we may develop.
−Removed: • Our acquisitions expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies.
−Removed: • We depend on a limited number of customers for a high percentage of our revenue.
−Removed: If we cannot maintain our current relationships with customers, fail to sustain recurring sources of revenue with our existing customers, or if we fail to enter into new relationships, our future operating results will be adversely affected.
−Removed: • We rely on a limited number of suppliers or, in some cases, sole suppliers, for some of our raw materials and may not be able to find replacements or immediately transition to alternative suppliers.
−Removed: • Our products could become subject to more onerous regulation by the FDA or other regulatory agencies in the future, which could increase our costs and delay or prevent commercialization of our products, thereby materially and adversely affecting our business, financial condition, results of operations, cash flows and prospects.
−Removed: • If we are unable to obtain, maintain and enforce intellectual property protection for our current or future products, or if the scope of our intellectual property protection is not sufficiently broad, our ability to commercialize our products successfully and to compete effectively may be materially adversely affected.
−Removed: • If we fail to comply with our obligations under any license agreements, disagree over contract interpretation, or otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are necessary to our business.
−Removed: • Our existing indebtedness could adversely affect our business and growth prospects.
−Removed: • Our principal asset is our interest in Maravai Topco Holdings, LLC (“Topco LLC”), and, accordingly, we depend on distributions from Topco LLC to pay our taxes and expenses, including payments under the Tax Receivable Agreement.
−Removed: Topco LLC’s ability to make such distributions may be subject to various limitations and restrictions.
−Removed: • Conflicts of interest could arise between our shareholders and Maravai Life Sciences Holdings, LLC (“MLSH 1”), which may impede business decisions that could benefit our shareholders.
−Removed: • The Tax Receivable Agreement requires us to make cash payments to MLSH 1 and Maravai Life Sciences Holdings 2, LLC (“MLSH 2”) in respect of certain tax benefits to which we may become entitled, and we expect that the payments we will be required to make will be substantial.
−Removed: • Our organizational structure, including the Tax Receivable Agreement, confers certain benefits upon MLSH 1 and MLSH 2 that will not benefit the other common shareholders to the same extent as they will benefit MLSH 1 and MLSH 2.
−Removed: • GTCR, LLC (“GTCR”) controls us, and its interests may conflict with ours or yours in the future.
−Removed: • Provisions of our corporate governance documents could make an acquisition of us more difficult and may prevent attempts by our shareholders to replace or remove our current management, even if beneficial to our shareholders.
+Added: The following is a summary of the material risks we and/or our shareholders face in the normal course of our business operations.
+Added: The list below is not exhaustive, and is qualified in its entirety by reference to the full risk factor discussion that follows this summary.
Risks Related to Our Business and Strategy
+Added: • The level of our customers’ spending on and demand for outsourced nucleic acid production and biologics safety testing products and services.
+Added: • Uncertainty regarding the extent and duration of our revenue associated with COVID-19-related products and services and the dependency of such revenue, in important respects, on factors outside our control.
+Added: • The impact of ongoing macroeconomic challenges and changes in economic conditions, including adverse developments affecting banks and financial institutions, follow-on effects of those events and related systemic pressures, on our and our customers’ current and future business operations.
+Added: • The effects of our recent reduction in force, including on our ability to attract and/or retain qualified key personnel.
+Added: • Use of our products by customers in the production of vaccines and therapies, some of which represent relatively new and still-developing modes of treatment, and the impact of unforeseen adverse events, negative clinical outcomes, development of alternative therapies, or increased regulatory scrutiny of these modes of treatment and their financial cost on our customers’ use of our products and services.
+Added: • Competition with life science, pharmaceutical and biotechnology companies who are substantially larger than us and potentially capable of developing new approaches that could make our products, services and technology obsolete.
+Added: • The potential failure of our products and services to not perform as expected and the reliability of the technology on which our products and services are based.
+Added: • The risk that our products do not comply with required quality standards.
+Added: • Market acceptance of our life science reagents.
+Added: • Significant fluctuations and unpredictability in our quarterly and annual operating results, which make our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
+Added: • Our ability to implement our strategic plan successfully.
+Added: • Natural disasters, geopolitical instability (including the ongoing military conflicts in Ukraine and the Gaza Strip) and other catastrophic events.
+Added: • Risks related to our acquisitions, including whether we achieve the anticipated benefits of acquisitions of businesses or technologies.
+Added: • Product liability lawsuits.
+Added: • Our dependency on a limited number of customers for a high percentage of our revenue and our ability to maintain our current relationships with such customers.
+Added: • Our reliance on a limited number of suppliers or, in some cases, sole suppliers, for some of our raw materials and the risk that we may not be able to find replacements or immediately transition to alternative suppliers.
+Added: • The risk that our products become subject to more onerous regulation by the FDA or other regulatory agencies in the future.
+Added: Risks Related to Our Intellectual Property and Technology
+Added: • Our ability to obtain, maintain and enforce sufficient intellectual property protection for our current or future products.
+Added: • The risk that a future cyber-attack or security breach cannot be prevented.
+Added: • Our ability to protect the confidentiality of our proprietary information
+Added: • The risk that one of our products may be alleged (or found) to infringe on the intellectual property rights of third parties.
+Added: • Compliance with our obligations under intellectual property license agreements.
+Added: • Our or our licensors’ failure to maintain the patents or patent applications in-licensed from a third party.
+Added: • Our ability to adequately protect our intellectual property and proprietary rights throughout the world.
+Added: Risks Related to Our Indebtedness
+Added: • Our existing level of indebtedness and our ability to raise additional capital on favorable terms.
+Added: • Our ability to generate sufficient cash flow to service all of our indebtedness.
+Added: • Our potential failure to meet our debt service obligations.
+Added: • Restrictions on our current and future operations under the terms applicable to the Credit Agreement.
+Added: Risks Related to Our Organizational Structure
+Added: • Our dependence, by virtue of our principal asset being our interest in Maravai Topco Holdings, LLC (“Topco LLC”), on distributions from Topco LLC to pay our taxes and expenses, including payments under a tax receivable agreement with the former owners of Topco LLC (the “Tax Receivable Agreement” or “TRA”) together with various limitations and restrictions that impact Topco LLC’s ability to make such distributions.
+Added: • The risk that conflicts of interest could arise between our shareholders and Maravai Life Sciences Holdings, LLC (“MLSH 1”), the only other member of Topco LLC, and impede business decisions that could benefit our shareholders.
+Added: • The substantial future cash payments we may be required to make under the Tax Receivable Agreement to MLSH 1 and Maravai Life Sciences Holdings 2, LLC (“MLSH 2”), an entity through which certain of our former owners hold their interests in the Company and the negative effect of such payments.
+Added: • The fact that our organizational structure, including the TRA, confers certain benefits upon MLSH 1 and MLSH 2 that will not benefit our other common shareholders to the same extent as they will benefit MLSH 1 and MLSH 2.
+Added: • Our ability to realize all or a portion of the tax benefits that are expected to result from the tax attributes covered by the Tax Receivable Agreement.
+Added: • The possibility that we will receive distributions from Topco LLC significantly in excess of our tax liabilities and obligations to make to make payments under the Tax Receivable Agreement.
+Added: • Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns.
+Added: Risks Related to Being a Public Company
+Added: • Risks related to our annual assessment of the effectiveness of our internal control over financial reporting, including the potential existence of any material weakness or significant deficiency.
+Added: Risks Related to Our Class A Common Stock
+Added: • The fact that investment entities affiliated with GTCR, LLC (“GTCR”) currently control a majority of the voting power of our outstanding common stock, and it may have interests that conflict with ours or yours in the future.
+Added: • Risks related to our “controlled company” status within the meaning of the corporate governance standards of NASDAQ.
+Added: • The potential anti-takeover effects of certain provisions in our corporate organizational documents.
+Added: • Potential sales of a significant portion of our outstanding shares of Class A common stock.
+Added: • Potential preferred stock issuance and the anti-takeover impacts of any such issuances.
+Added: Risks Related to Our Business and Strategy
+Added: 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.
+Added: 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.
+Added: The success of our business depends primarily on the number and size of contracts with our customers, primarily pharmaceutical and biotechnology companies, for our products and services.
+Added: For example, during the COVID-19 pandemic we benefited from a significant increase in demand for our products and service, including our proprietary CleanCap® analogs that are used by our customers in the production of COVID-19 vaccines, and also benefited during 2021 and 2022, more generally, from the overall growth of the global biologics market, higher research and development budgets of our customers and a greater degree of outsourcing by our customers.
+Added: The level of our customers’ spending on and demand for our products and services is also subject to, among other things, their own financial performance, changes in their available resources, the timing of their commercial manufacturing initiatives, their decisions to acquire in-house manufacturing capacity (rather than outsource), their spending priorities, including research and development budgets, and their budgetary policies and practices, which, in turn, are dependent upon a number of factors outside of our control.
+Added: Our customers determine their research and development budgets based on several factors, including their need to develop new biological products, their competitors’ discoveries, developments and commercial manufacturing initiatives and the anticipated market, clinical and reimbursement scenarios for specific products and therapeutic areas.
+Added: In addition, consolidation in the industries in which our customers operate may have an impact on our customers’ spending as they integrate acquired operations, including research and development departments and associated budgets.
+Added: 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.
+Added: Declines and uncertainties in the capital markets, including as a result of ongoing negative macroeconomic challenges, rising interest rates, recent instability in the banking sector, and volatile credit markets, have limited access to capital and negatively affected companies’ ability to fund research and development efforts.
+Added: While 2021 and 2022 saw a significant level of investment in venture- and private equity-backed startup companies, funding for companies at all stages, and particularly early- and late-stage companies, contracted considerably during 2023, which, together with broader economic uncertainty, 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.
+Added: We have no assurance as to whether, or when, such research and development spending may stabilize or increase, if at all.
+Added: 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.
+Added: If our customers reduce their spending on our products and services as a result of any of these or other factors, our business, financial condition, results of operations, cash flows and prospects would be materially and adversely affected.
+Added: Moreover, we have no control over the timing and volume of purchases by our customers, and as a result, our operating results may fluctuate significantly, and our future revenue and operating results can be difficult to forecast.
+Added: Our inability to forecast fluctuations in demand could harm our business, financial position and future results of operations.
+Added: See also “— Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide ” below.
The extent and duration of our revenue associated with COVID-19 related products and services are uncertain and are dependent, in important respects, on factors outside our control.
Certain of our products, including our proprietary CleanCap® analogs, are used by our customers in the production of COVID-19 vaccines.
−Removed: While our results of operations and cash flows have been positively impacted by a strong demand for our proprietary CleanCap analogs and ongoing demand for highly modified RNA products, particularly mRNA, the evolving nature of the COVID-19 pandemic and the resulting global public health response will affect the continued demand for our COVID-19 related products and services, which have comprised the majority of our revenue for the past three years.
+Added: 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 a strong demand for our proprietary Cle anCap® ana logs and highly modified RNA products, particularly mRNA.
+Added: 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.
+Added: 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 COVID-19 related revenue during the year ended December 31, 2023.
For the years ended December 31, 2023, 2022 and 2021, we estimate that revenue from COVID-19 related products and services represented approximately 21.0%, 67.9% and 69.7%, respectively, of our total revenues.
−Removed: 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 duration of the pandemic;
−Removed: emerging information concerning the severity and incidence of the virus and its variants;
−Removed: the emergence of additional virus variants;
+Added: We expect to experience
+Added: further declines in COVID-19 related revenue 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.
+Added: 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 COVID-19 related products.
+Added: Our longer-term revenue prospects for COVID-19 related products are highly uncertain but are expected to be substantially less than pandemic highs.
+Added: 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;
−Removed: the rate at which the population globally becomes vaccinated against COVID-19;
−Removed: the development and availability of antiviral therapeutic alternatives;
+Added: the availability and administration of pediatric and booster vaccinations, vaccine supply constraints, vaccine hesitancy and the effectiveness of vaccines against new virus strains;
+Added: competition faced by our customers from other COVID-19 vaccine manufacturers and the development and availability of antiviral therapeutic alternatives;
the lapsing of the public health emergency declaration made pursuant to Section 319 of the Public Health Service Act in January 2020 with respect to the COVID-19 pandemic;
−Removed: and political and social debate relating to the need for, efficacy of, or side effects related to one or more specific COVID-19 vaccines.
+Added: political and social debate relating to the need for, efficacy of, or side effects related to one or more specific COVID-19 vaccines;
+Added: economy and global economy, including impacts resulting from supply chain constraints, labor market shortages and inflationary pressures.
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 our COVID-19 related products and services will significantly decrease, which would have a material adverse effect on our revenue, results of operations and financial condition.
−Removed: Changes in economic conditions could negatively impact our revenue and earnings.
+Added: Ongoing macroeconomic challenges and changes in economic conditions, including adverse developments affecting banks and financial institutions, follow-on effects of those events and related systemic pressures, could negatively impact, directly or indirectly, our and our customers’ current and future business operations and our financial condition, revenue and earnings.
Our reagents are sold primarily to biopharmaceutical and academic organizations developing novel vaccines and therapies and performing basic research.
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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.
−Removed: Our nucleic acid production customers are largely vaccine and therapeutic drug makers or diagnostics manufacturers, which rely in
−Removed: part on government healthcare-related policies and funding.
−Removed: As a result, changes in government funding for certain research, decreases in or the imposition of limits on government spending more generally (including as a result of the U.S.
−Removed: federal debt ceiling), or reductions in overall healthcare spending could negatively impact us or our customers and, correspondingly, our sales to them.
+Added: 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.
+Added: As a result, changes in government funding for certain research, decreases in or the imposition of limits on government spending more generally (including as a result of the ongoing appropriations process for the US.
+Added: federal government’s fiscal year 2024), or reductions in overall healthcare spending could negatively impact us or our customers and, correspondingly, our sales to them.
In particular, if the U.S.
−Removed: Congress fails to increase the U.S.
−Removed: federal debt ceiling, reimbursements we are eligible to receive under the Cooperative Agreement we entered into with the U.S.
+Added: Congress fails to pass appropriate appropriations measures or enact another continuing resolution, reimbursements we are eligible to receive under the Cooperative Agreement we entered into with the U.S.
Department of Defense may be jeopardized, which would negatively affect our business, operations and financial condition.
Currently, the U.S.
−Removed: and global economies are experiencing ongoing macroeconomic challenges, including labor shortages, supply chain disruptions and historic rates of inflation, which have led to increasing interest rates, volatility in the capital and credit markets, and fiscal and monetary policy uncertainty.
+Added: and global economies are experiencing ongoing macroeconomic challenges, including labor shortages, supply chain disruptions and persistent inflation, which have led to increasing interest rates, volatility in the capital and credit markets, and fiscal and monetary policy uncertainty.
Our business operations, as well as our customers’ and suppliers’ business operations, have been impacted, and are expected to continue to be impacted, by these negative conditions.
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Further deterioration or a protracted extension of these negative macroeconomic conditions, a potential economic downturn or recession, or a significant reduction or delay in governmental funding as a result of U.S.
−Removed: federal budget issues, or the perception that any of these events may occur, could cause a decline in demand for our products and services and adversely affect our performance and result in declines in our revenue and earnings.
+Added: federal budget
+Added: issues, or the perception that any of these events may occur, could cause a decline in demand for our products and services and adversely affect our performance and result in declines in our revenue and earnings.
+Added: Our recent reduction in force may have unintended consequences, including business disruption, cause us to experience difficulties attracting and/or retaining qualified key personnel, which could negatively impact our ability to develop and market our products and services and our overall performance.
+Added: On November 7, 2023, we announced a workforce reduction of approximately 15% of our total full-time workforce (the “Reduction in Force”).
+Added: The Reduction in Force resulted in the elimination of 102 full-time positions.
+Added: Although the majority of the positions eliminated were intended to address excess manufacturing capacity, relative to current demand, this reduction has resulted in certain reallocations of employee duties.
+Added: As a result, inefficiencies related to task unfamiliarity, heavier workloads, loss of knowledge and unfilled gaps may arise, especially if we are unable to effectively manage and implement the transition of impacted employees’ duties and responsibilities.
+Added: Any such inefficiencies may cause disruption or delay in our business activities.
+Added: The Reduction in Force and resulting job reassignments could also negatively affect employee morale and make it more difficult to motivate and retain our remaining personnel.
+Added: In addition, our future success depends largely upon the continued service of our management and scientific staff and our ability to attract, retain and motivate highly skilled technical, scientific, management and marketing personnel, who deliver high-quality and timely services to our customers and keep pace with cutting-edge technologies and developments in biologics.
+Added: We face significant competition in the hiring and retention of such personnel from other companies, other providers of outsourced biologics services, research and academic institutions, government and other organizations who have superior funding and resources and who may use these resources to pursue personnel more aggressively than we are.
+Added: Additionally, certain highly skilled personnel that we seek to employ may be subject to non-competition or other restrictive covenants restricting their ability to work for us or within certain aspects of our business for a period of time.
+Added: Although some jurisdictions (including the State of California) prohibit non-competition agreements as a matter of law, and the U.S.
+Added: Federal Trade Commission has issued a notice of proposed rulemaking that would prohibit employers in the U.S.
+Added: from using non-compete agreements, if we hire certain employees from competitors or other companies, those former employers may attempt to assert that these employees and/or we have breached certain legal obligations, resulting in a diversion of our time and resources.
+Added: We have, from time to time, experienced, and we expect to continue to experience, difficulty in hiring and retaining employees with appropriate qualifications.
+Added: In recent years, recruiting, hiring and retaining employees with expertise in our industry and in the geographies where we operate has become increasingly difficult as the demand for skilled professionals has increased and as a result of labor shortages believed to have resulted from actions taken during the onset of the COVID-19 pandemic, but which remained following the recovery and which we expect will continue beyond the near-term.
+Added: These difficulties may be heightened as a result of the Reduction in Force.
+Added: The loss of key personnel or our inability to hire and retain skilled personnel could materially adversely affect the development of our products and services and our business, financial condition, results of operations, cash flows and prospects.
Certain of our products are used by customers in the production of vaccines and therapies, some of which represent relatively new and still-developing modes of treatment.
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Our customers’ use of our products and services in therapeutic and vaccine development programs for other (non-COVID-19-related) indications could be impacted by more restrictive regulations or negative public perception, which could negatively affect our business prospects, revenue and results of operation.
−Removed: We are dependent on our customers’ spending on and demand for outsourced nucleic acid production and biologics safety testing products and services.
−Removed: A reduction in spending or demand could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.
−Removed: The success of our business depends primarily on the number and size of contracts with our customers, primarily pharmaceutical and biotechnology companies, for our products and services.
−Removed: As discussed above, during the COVID-19 pandemic we benefited from a significant increase in demand for our products and service, including our proprietary CleanCap® analogs that are used by our customers in the production of COVID-19 vaccines, and more generally, as a result of the continued growth of the global biologics market, increasing research and development budgets of our customers and a greater degree of outsourcing by our customers.
−Removed: A slowing or reversal of any of these trends, including a decrease in the amount of COVID-19 vaccines manufactured or supplied by our customers, could have a significant adverse effect on the demand for our products and services.
−Removed: In addition to these industry trends, our customers’ willingness and ability to utilize our products and services are also subject to, among other things, their own financial performance, changes in their available resources, their decisions to acquire in-house manufacturing capacity, their spending priorities, their budgetary policies and practices and their need to develop new biological products, which, in turn, are dependent upon a number of factors, including their competitors’ discoveries, developments and commercial manufacturing initiatives and the anticipated market, clinical and reimbursement scenarios for specific products and therapeutic areas.
−Removed: In addition, consolidation in the industries in which our customers operate may have an impact on our customers’ spending as they integrate acquired operations, including research and development departments and associated budgets.
−Removed: If our customers reduce their spending on our products and services as a result of any of these or other factors, our business, financial condition, results of operations, cash flows and prospects would be materially and adversely affected.
We compete with life science, pharmaceutical and biotechnology companies who are substantially larger than we are and potentially capable of developing new approaches that could make our products, services and technology obsolete.
The market for pharmaceutical, reagent, therapeutic and diagnostic products and services is intensely competitive, rapidly evolving, significantly affected by new product introductions and other market activities by industry participants and subject to rapid technological change.
−Removed: We also expect increased competition as additional companies enter our market and as more advanced technologies become available.
+Added: We also expect increased competition as additional companies enter our market and as more
+Added: advanced technologies become available.
We compete with other providers of outsourced biologics products and services.
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Although our products are tested prior to shipment, defects or errors could nonetheless occur.
−Removed: Our operating results depend on our ability to execute and, when necessary, improve our quality management strategy and systems and our ability to effectively
−Removed: train and maintain our employee base with respect to quality management.
+Added: Our operating results depend on our ability to execute and, when necessary, improve our quality management strategy and systems and our ability to effectively train and maintain our employee base with respect to quality management.
A failure of our quality control systems could result in problems with facility operations or preparation or provision of products.
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Although we have taken steps to improve our quality review, product documentation and reference testing procedures, we cannot guarantee that we will not experience quality assurance issues with our products in the future.
−Removed: Any such failure could, among other things, lead to increased costs, delayed or lost revenue, delayed market acceptance, damaged reputation, diversion of development resources, legal claims, reimbursement to customers for lost drug product, starting materials and active pharmaceutical ingredients, other customer claims, damage to and possibly termination of existing customer relationships, increased insurance costs, time and expense spent investigating the cause and, depending on the cause, similar losses with respect to other batches or products, any of which could harm our business, financial condition, results of operations, cash flows and prospects.
+Added: Any such failure could, among other things, lead to increased costs, delayed or lost revenue, delayed market acceptance, damaged reputation, diversion of development resources,
+Added: legal claims, reimbursement to customers for lost drug product, starting materials and active pharmaceutical ingredients, other customer claims, damage to and possibly termination of existing customer relationships, increased insurance costs, time and expense spent investigating the cause and, depending on the cause, similar losses with respect to other batches or products, any of which could harm our business, financial condition, results of operations, cash flows and prospects.
Such defects or errors could also narrow the scope of the use of our products, which could hinder our success in the market.
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Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
−Removed: Our quarterly and annual operating results may fluctuate significantly, which makes it difficult for us to predict our future operating results.
+Added: We have no control over the timing and volume of purchases by our customers.
+Added: 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.
These fluctuations may be driven by a variety of factors, many of which are outside of our control, including, but not limited to:
−Removed: • demand from our largest customers for COVID-19-related products and services (which currently comprise a significant percentage of our revenue and orders) may not meet our expectations regarding volume and price in any given time period;
−Removed: • the level of demand for our other (non-COVID-19-relate) products and services, which may vary significantly;
+Added: • unused inventory of our products that our customers have on hand, which are not indication-specific, and our lack of insight as to the amount of unused inventory of our products that such customers have on hand;
+Added: • changes in the level of our customers’ spending on and demand for our products and services, including as a result of, among other things, their own financial performance, changes in their available resources, timing of their commercial manufacturing initiatives, their decision to acquire in-house manufacturing capacity (rather than outsource), their spending priorities, including research and development budgets, and their budgetary policies and practices;
• our ability to increase penetration in our existing markets and expand into new markets;
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• difficulties encountered by our commercial carriers in delivering our products, whether as a result of external factors such as weather or negative macroeconomic conditions or internal issues such as labor disputes;
−Removed: • general market conditions and other factors outside of our control, such as natural disasters, geopolitical unrest, war, terrorism, public health issues (including the ongoing COVID-19 pandemic) or other catastrophic events;
+Added: • the timing and magnitude of any adjustments to the Tax Receivable Agreement liability;
+Added: • changes in the assessment of the realizability of our deferred tax assets;
+Added: • general market conditions and other factors outside of our control, such as natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events;
• the other factors described in this “Risk Factors” section.
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In addition, we must maintain sufficient production capacity in order to meet anticipated customer demand, and we may be unable to offset the associated fixed costs if orders slow, which would adversely affect our operating margins.
−Removed: If we are unable
−Removed: to manufacture and ship our products consistently, in sufficient quantities and on a timely basis, our revenue, cash flow, gross margins and our other results of operations will be materially and adversely affected.
−Removed: A pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19, has affected, and may continue to affect our business, financial condition, results of operations, cash flows and prospects.
−Removed: The COVID-19 pandemic led to the implementation of various responses, including government imposed shelter-in-place orders, quarantines, travel restrictions and other public health safety measures, as well as reported adverse impacts on healthcare resources, facilities and providers across the United States and in other countries.
−Removed: In response to the spread of COVID-19, we restricted access to our facilities mostly to personnel and third parties required to perform critical activities that must be completed on-site, limited the number of such personnel that can be present at our facilities at any one time, and requested that many of our personnel work remotely.
−Removed: In the event that government authorities are willing to reimplement restrictions in response to a new variant of concern or increased infection rates, our employees conducting research and development or manufacturing activities may not be able to access our laboratory or manufacturing facilities and our core activities may be significantly limited or curtailed, possibly for an extended period of time.
−Removed: As a result of the COVID-19 pandemic, or similar pandemics and outbreaks that may occur in the future, we have experienced and may in the future experience severe disruptions, including:
−Removed: • interruption of or delays in receiving products and supplies from the third parties we rely on to, among other things, manufacture components to our products, due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems, which may impair our ability to manufacture and sell our products and services;
−Removed: • limitations on our business operations by the local, state or federal government that could impact our ability to manufacture, sell or deliver our products and services;
−Removed: • on-site visit limitations and prohibitions imposed by customers that could impact our ability to engage in pre-sales activities, and to provide post-sale activities, such as training, service and support;
−Removed: • delays in customers’ purchasing decisions and negotiations with customers and potential customers;
−Removed: • business disruptions caused by workplace, laboratory and office closures and an increased reliance on employees working from home, travel limitations, cyber security and data accessibility limits, or communication or mass transit disruptions;
−Removed: • limitations on employee resources that would otherwise be focused on the conduct of our activities, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
−Removed: • reductions in productivity of our customers in certain countries or regions due to government-mandated shutdowns and quarantines, such as China’s Zero Covid Policy;
−Removed: • increased competition as quarantines and shelter-in-place orders are lifted by governments in regions where our competitors, particularly international competitors, are located.
−Removed: Any of these factors could severely impact our research and development activities, manufacturing business operations and sales or delay necessary interactions with local regulators, third-party vendors and other important contractors and customers.
−Removed: The extent to which the current or any future pandemic may negatively impact our consolidated operations and results of operations or those of our third-party manufacturers, suppliers, partners or customers continues depend on future developments.
−Removed: The factors that could cause such adverse impact include:
−Removed: the severity and duration of the pandemic;
−Removed: the emergence of new virus variants;
−Removed: lack of demand for vaccines;
−Removed: economy and global economy, including impacts resulting from supply chain constraints and inflationary pressures;
−Removed: and the timing, scope and effectiveness of U.S.
−Removed: and international governmental, regulatory, fiscal, monetary and public health responses to such pandemic and associated economic disruptions.
−Removed: Ongoing geopolitical instability has resulted in economic disruption and uncertainty, which may negatively impact our business, operations, and financial condition.
−Removed: Russia’s military invasion of Ukraine in late February 2022 further exacerbated ongoing inflationary pressures, supply chain issues, and volatility in credit and capital markets, and caused other market disruptions.
−Removed: Additionally, the United States, the European Union and other countries have levied sanctions against Russia and certain other countries, regions, and individuals as a result of Russia’s military actions in Ukraine, and Russian has imposed its own sanctions and threatened further retaliatory actions.
−Removed: The aforementioned factors have caused damage and disruption to international commerce and the global economy, and a protracted conflict between Russian and Ukraine, any escalation of said conflict (including the spread of the conflict to
−Removed: other countries in Europe), or additional geopolitical turmoil (such as a further degradation of China-Taiwan relations or trade relations between China and the United States), could worsen economic and financial markets and international relations.
−Removed: Such geopolitical instability could create supply disruptions and logistics restrictions that increase our costs, have a detrimental effect on our ability to manufacture, sell and ship our products, and impede our ability to collect payments and support customers in certain regions.
−Removed: Furthermore, the global economy and financial and capital markets could also be further adversely affected, resulting in instability and lack of liquidity in capital markets, which could also negatively impact the value of our stock or our ability to obtain equity or debt funding.
−Removed: In addition, there are other challenges, difficulties, and risks with respect to the way we conduct our business and operations, generally, that we may experience as a result of continued or increased geopolitical turmoil.
−Removed: For example, the ongoing Russia-Ukraine military conflict may create an increased risk of cybersecurity attacks, including by or at the direction of the Russian government, in response to financial and economic sanctions and import and/or export controls imposed on Russia by the United States and others.
−Removed: While at this time, to the best of our knowledge, we do not believe we have experienced any such cyberattacks, we may not be able to address any such cybersecurity threats proactively or implement adequate preventative measures, and prompt detection and remediation of any such disruption or security breach may be difficult, if not impossible.
−Removed: The foregoing factors could negatively affect our business, operations and financial condition, though we are unable to predict the extent or nature of any such impacts at this time.
−Removed: Any such disruptions may also increase the impact of other risks described herein, both with respect to their severity and frequency.
+Added: If we are unable to manufacture and ship our products consistently, in sufficient quantities and on a timely basis, our revenue, cash flow, gross margins and our other results of operations will be materially and adversely affected.
Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of products and services, as well as our sites, which could negatively affect our operations and performance.
−Removed: We are subject to the risk of disruption by earthquakes, hurricanes, floods and other natural disasters, fire, power shortages, geopolitical unrest, war, terrorist attacks and other hostile acts, public health issues, epidemics or pandemics, such as the COVID-19 pandemic, and other events beyond our control and the control of the third parties on which we depend.
+Added: 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 Gaza Strip), 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.
We rely upon our internal manufacturing, packaging and distribution operations to produce many of the products we sell and our warehouse facilities to store products pending sale.
−Removed: Any significant disruption of those operations for any reason, such as labor disputes or social unrest, power interruptions, fire, hurricanes, a pandemic (including the ongoing COVID-19 pandemic), earthquakes or other events beyond our control, could adversely affect our sales and customer relationships and therefore adversely affect our business and results of operations.
+Added: Any significant disruption of those operations for any reason, such as
+Added: labor disputes or social unrest, power interruptions, fire, hurricanes, a public health crisis (such as a pandemic), earthquakes or other events beyond our control, could adversely affect our sales and customer relationships and therefore adversely affect our business and results of operations.
We have significant operations in California, near major earthquake faults, which make us susceptible to earthquake risk.
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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.
−Removed: If we are unable to continue to hire and retain skilled personnel, we will have trouble developing and marketing our products and services.
−Removed: Our success depends largely upon the continued service of our management and scientific staff and our ability to attract, retain and motivate highly skilled technical, scientific, management and marketing personnel, who deliver high-quality and timely services to our customers and keep pace with cutting-edge technologies and developments in biologics.
−Removed: We face significant competition in the hiring and retention of such personnel from other companies, other providers of outsourced biologics services, research and academic institutions, government and other organizations who have superior funding and resources and who may use these resources to pursue personnel more aggressively than we are.
−Removed: Additionally, certain highly skilled personnel that we seek to employ may be subject to non-competition or other restrictive covenants restricting their ability to work for us or within certain aspects of our business for a period of time.
−Removed: Although some jurisdictions (including the State of California) prohibit non-competition agreements as a matter of law, and the U.S.
−Removed: Federal Trade Commission has issued a notice of proposed rulemaking that would prohibit employers in the U.S.
−Removed: from using non-compete agreements, if we hire certain employees from competitors or other companies, those former employers may attempt to assert that these employees and/or we have breached certain legal obligations, resulting in a diversion of our time and resources.
−Removed: We have, from time to time, experienced, and we expect to continue to experience, difficulty in hiring and retaining employees with appropriate qualifications.
−Removed: In recent years, recruiting, hiring and retaining employees with expertise in our industry and in the geographies where we operate has become increasingly difficult as the demand for skilled professionals has increased and as a result of labor shortages believed to have resulted from actions taken during the onset of the COVID-19 pandemic, but which are expected to continue beyond the near-term.
−Removed: The loss of key personnel or our inability to hire and retain skilled personnel could materially adversely affect the development of our products and services and our business, financial condition, results of operations, cash flows and prospects.
Our commercial success depends on the market acceptance of our life science reagents.
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The commercial success of all of our products and services will depend upon their acceptance by the life science and biopharmaceutical industries.
−Removed: Some of the products and services that we are developing are based upon new technologies or
−Removed: As a result, there can be no assurance that these new products and services, even if successfully developed and introduced, will be accepted by customers.
+Added: Some of the products and services that we are developing are based upon new technologies or approaches.
+Added: As a result, there can be no assurance that these new products and services, even if successfully developed and
+Added: introduced, will be accepted by customers.
If customers do not adopt our new products, services and technologies, our results of operations may suffer and, as a result, the market price of our Class A common stock may decline.
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Even if the markets in which we compete meet our size estimates and growth forecasts, our business could fail to grow at the rate we anticipate, if at all.
+Added: If we are unable to successfully implement our strategic plan on a timely basis or at all, our business and future result of operations may be adversely impacted.
+Added: Our strategic plan was developed based upon market and technology trends that we currently believe present revenue growth opportunities, and in turn, long-term shareholder value creation.
+Added: Our strategic plan includes a series of strategic priorities and cost realignment initiatives designed to drive growth and improve operational efficiency.
+Added: Our ability to achieve our strategic initiatives is subject to a number of risks, including those discussed herein under the heading “ Risks Related to Our Business and Strategy ,” as well as challenges we face with executing multiple initiatives simultaneously.
+Added: For example, our commercial initiatives may not succeed, or we may lose market share due to challenges in choosing the right products to develop or the right customers to target for these products, or integrating products of acquired companies into our sales and marketing strategy.
+Added: We cannot assure you that we will overcome the risks associated with our strategic initiatives.
+Added: If we fail to manage or overcome those risks, we may not realize the intended benefits of our strategic plan and may incur additional expenses without related revenue growth.
+Added: Our business, financial position and results of operations will be adversely affected if we fail to successfully implement our strategic initiatives or if we invest resources in a growth strategy that ultimately proves to be unsuccessful.
Product liability lawsuits against us could cause us to incur substantial liabilities, limit sales of our existing products and limit commercialization of any products that we may develop.
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We have made in the past, and may make in the future, selected opportunistic acquisitions of complementary businesses, products, services or technologies.
−Removed: In January 2022, we acquired MyChem LLC, a provider of proprietary, ultra-pure
−Removed: nucleotides to customers in the diagnostics, pharma, genomics and research markets to complement our nucleic acid business and 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.
+Added: In January 2022, we acquired MyChem LLC, a provider of proprietary, ultra-pure nucleotides to customers in the diagnostics, pharma, genomics and research markets to complement our nucleic acid business and 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.
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.
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We also recognize revenue from other contracts that may include a combination of products and services, the provision of solely services, or from license fee arrangements which may be associated with the delivery of product.
−Removed: Our application of the revenue recognition accounting
−Removed: guidance with respect to the nature of future contractual arrangements could impact the forecasting of our revenue for future periods, as both the mix of products and services we will sell in a given period, as well as the size of contracts, is difficult to predict.
+Added: Our application of the revenue recognition accounting guidance with respect to the nature of future contractual arrangements could impact the forecasting of our revenue for future periods, as both the mix of products and services we will sell in a given period, as well as the size of contracts, is difficult to predict.
Furthermore, the presentation of our financial results requires us to make estimates and assumptions that may affect revenue recognition.
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Our future success depends on our ability to maintain these relationships, to increase our penetration among these existing customers and to establish new relationships.
−Removed: We engage in conversations with other companies and institutions regarding potential commercial opportunities on an ongoing basis, which can be time consuming.
+Added: We engage in conversations with other companies and institutions regarding
+Added: potential commercial opportunities on an ongoing basis, which can be time consuming.
There is no assurance that any of these conversations will result in a commercial agreement, or if an agreement is reached, that the resulting relationship will be successful.
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Any failure to increase penetration in our existing markets would adversely affect our ability to improve our operating results.
−Removed: We may enter into additional distribution arrangements and marketing alliances for certain products and services and any failure to successfully identify and implement these arrangements on favorable terms, if at all, may impair our ability to effectively distribute and market our products.
−Removed: We may pursue additional arrangements regarding the sales and marketing and distribution of one or more of our products and services and our future revenue may depend, in part, on our ability to enter into and maintain arrangements with other companies having sales, marketing and distribution capabilities and the ability of such companies to successfully market and
−Removed: sell any such products and services.
+Added: We rely on distribution arrangements to market and sell our products and services, including in certain international markets, and our failure to maintain and successfully manage these arrangements or to renew or identify and implement additional arrangements on favorable terms, if at all, may impair our ability to effectively distribute and market our products and adversely impact our revenues and future results of operations.
+Added: We rely on certain distributors in order to market and sell our products and services in in certain international markets, particularly our biologics safety testing products and services in China.
+Added: Our distributor in China accounted for 4.8 % of our total revenues in the year ended December 31, 2023.
+Added: 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.
+Added: Additionally, changes in the inventory levels of our products owned and held by our distributors can result in significant variability in our revenues.
+Added: 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 .”
+Added: We may pursue additional arrangements regarding the sales and marketing and distribution of one or more of our products and services, including if we intend to grow our business internationally in certain geographic markets, and the success of our strategic initiatives and our future revenue growth may depend, in part, on our ability to enter into and maintain arrangements with other companies having sales, marketing and distribution capabilities and the ability of such companies to successfully market and sell any such products and services.
Any failure to enter into such arrangements and marketing alliances on favorable terms, if at all, could delay or impair our ability to distribute or market our products and services and could increase our costs of distribution and marketing.
−Removed: Any use of distribution arrangements and marketing alliances to commercialize our products and services will subject us to a number of risks, including the following:
+Added: Our use of distribution arrangements and marketing alliances to commercialize our products and services subject us to a number of risks, including the following:
• we may be required to relinquish important rights to our products;
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In addition, if one or more of these third-party package-delivery providers were to increase prices, and we were not able to find comparable alternatives or make adjustments in our delivery network, our profitability could be adversely affected.
−Removed: Furthermore, if one or more of these third-party package-delivery providers were to experience performance problems
−Removed: or other difficulties, it could negatively impact our operating results and our customers’ experience.
+Added: Furthermore, if one or more of these third-party package-delivery providers were to experience performance problems or other difficulties, it could negatively impact our operating results and our customers’ experience.
In the past, some of our products have sustained serious damage in transit such that they were no longer usable.
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federal, U.S.
−Removed: state, and/or international data breach notification laws and regulations.
+Added: state, and/or international data
+Added: breach notification laws and regulations.
Other jurisdictions outside the EU are similarly introducing or enhancing privacy and data security laws, rules and regulations, which could increase our compliance costs and the risks associated with noncompliance.
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We may also be adversely affected through other penalties, reputational harm, loss of access to certain markets, or otherwise.
−Removed: Complying with export control and sanctions
−Removed: regulations may be time consuming and may result in the delay or loss of sales opportunities or impose other costs.
+Added: Complying with export control and sanctions regulations may be time consuming and may result in the delay or loss of sales opportunities or impose other costs.
Any change in export or import regulations, economic sanctions or related legislation, or change in the countries, governments, persons or technologies targeted by such regulations, could result in our decreased ability to export or sell certain products and services to existing or potential customers in affected jurisdictions.
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inadequate local infrastructure and difficulties in managing and staffing international operations;
−Removed: delays resulting from difficulty in obtaining export licenses for certain technology;
+Added: delays resulting from difficulty in obtaining export licenses for
+Added: certain technology;
tariffs, quotas and other trade barriers and restrictions;
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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.
−Removed: In particular, these constituencies are increasingly focusing on environmental stewardship, including climate change, water use, deforestation, waste, and other sustainability concerns, as well as diversity and inclusion, workplace conduct, support for local communities, and other human capital and social issues.
+Added: In particular, these constituencies are increasingly focusing on environmental stewardship, including climate change, water use, deforestation,
+Added: waste, and other sustainability concerns, as well as diversity and inclusion, workplace conduct, support for local communities, and other human capital and social issues.
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.
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We rely upon a combination of patents and trade secret protection to protect the intellectual property related to our technology, manufacturing processes, and products.
−Removed: Our commercial success depends in part on obtaining and maintaining patent and trade secret protection of our current and future products, if any, and the methods used to manufacture them, as well as successfully defending such patents and trade secrets against third-party challenges.
+Added: Our commercial success depends in part on obtaining and maintaining patent and trade secret protection for our current and future products, if any, and the methods used to manufacture them, as well as successfully defending and protecting such patents and trade secrets against third-party challenges.
Our ability to stop third parties from making, using, selling, offering to sell or importing our products is dependent upon the extent to which we have rights under valid and enforceable patents and other intellectual property that covers these activities.
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We may be unaware of prior art that could be used to invalidate or narrow the scope of an issued patent or prevent our pending patent applications from issuing as patents.
−Removed: Because patent applications in the United States, Europe and many other non-U.S.
+Added: This may be (1) because patent applications in the United States, Europe and many other non-U.S.
jurisdictions are typically not published until 18 months after filing, or in some cases not at all, (2) because publications of discoveries in scientific literature lag behind actual discoveries, and (3) because we cannot be certain that we or our licensors were the first to make the inventions claimed in any of our owned or any in-licensed issued patents or pending patent applications, or that we or our licensors were the first to file for protection of the inventions set forth in our patents or patent applications.
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In any of these types of proceedings, a court or agency of competent jurisdiction may find our patents invalid or unenforceable.
−Removed: Our competitors and other third parties may also be able to
−Removed: circumvent our patents by developing similar or alternative products in a non-infringing manner.
+Added: Our competitors and other third parties may also be able to circumvent our patents by developing similar or alternative products in a non-infringing manner.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.
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Furthermore, patents have a limited lifespan.
−Removed: In the United States, the unextended expiration of a patent is 20 years after its non-provisional filing date.
+Added: In the United States, the unextended expiration of a patent is generally 20 years after its non-provisional application filing date.
Various extensions may be available, however, the life of a patent and the protection it affords is limited.
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Proposed actions to waive intellectual property protections for COVID-19 vaccines and associated technology, such as those under discussion at the World Trade Organization, which are supported by the U.S.
−Removed: government, may impact our ability to fully assert our intellectual property rights related to our CleanCap product in
−Removed: connection with the production of COVID-19 vaccines.
+Added: government, may impact our ability to fully assert our intellectual property rights related to our Clea nCap® pro duct in connection with the production of COVID-19 vaccines.
Further, these policy actions may complicate our analysis and decision-making with respect to both research and development and capital investment, given the potential for lower returns on those investments that could result from our inability to fully protect our intellectual property.
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We could be required to expend significant amounts of money and other resources to respond to these threats or breaches and to repair or replace information systems or networks and could suffer financial loss or the loss of valuable confidential information.
−Removed: In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices.
+Added: In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations,
+Added: including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices.
Although we develop and maintain systems and controls designed to prevent these events from occurring, and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become increasingly sophisticated.
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However, trade secrets are difficult to protect.
−Removed: use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, collaborators, CDMOs, CROs and others may unintentionally or willfully disclose our information to competitors.
+Added: Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, collaborators, CDMOs, CROs and others may unintentionally or willfully disclose our information to competitors.
We also face the risk that present or former employees could continue to hold rights to intellectual property used by us, demand the registration of intellectual property rights in their name, and seek payment of damages for our use of such intellectual property.
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The life sciences industry has produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use.
+Added: Because the patent granting process is imperfect, the manufacture, distribution, or sale of our products may require us to challenge intellectual property rights by third parties that we believe to have been improperly granted.
The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
If we are sued for patent infringement, we would need to demonstrate that our products or methods of use either do not infringe the patent claims of the relevant patent and/or that the patent claims are invalid or unenforceable, and we may not be able to do this.
−Removed: Proving invalidity, in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.
−Removed: Third parties have, and may in the future have, U.S.
+Added: Proving invalidity, in particular, is difficult since it requires a showing of clear and convincing evidence in trial court litigation to overcome the presumption of validity enjoyed by issued patents.
+Added: Third parties have, and may
+Added: in the future have, U.S.
issued patents and pending patent applications that may cover our current or future products.
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In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent.
−Removed: Further, if a patent infringement suit is brought against us or
−Removed: our third-party service providers and if we are unable to successfully obtain rights to required third-party intellectual property, we may be required to expend significant time and resources to redesign our current or future products, or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis, and may delay or require us to abandon our development, manufacturing or sales activities relating to our current or future products.
+Added: Further, if a patent infringement suit is brought against us or our third-party service providers and if we are unable to successfully obtain rights to required third-party intellectual property, we may be required to expend significant time and resources to redesign our current or future products, or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis, and may delay or require us to abandon our development, manufacturing or sales activities relating to our current or future products.
A finding of infringement could prevent us from commercializing our future products or force us to cease some of our business operations, which could harm our business.
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patents in lawsuits in U.S.
−Removed: federal courts, and use a lower burden of proof
−Removed: than used in litigation in U.S.
+Added: federal courts, and use a lower burden of proof than used in litigation in U.S.
federal courts.
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We may not be able to protect our intellectual property and proprietary rights throughout the world.
−Removed: Filing, prosecuting, and defending patents on current or future products in all countries throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the
−Removed: United States.
+Added: Filing, prosecuting, and defending patents on current or future products in all countries throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States.
+Added: For example, patent scope or coverage varies between countries based on the differences between the respective patent laws in each country or jurisdiction.
Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.
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Any breach of our confidentiality agreements or our failure to effectively enforce such agreements would have a material adverse effect on our business and competitive position.
−Removed: If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business, financial condition, results of operations, cash flows and prospects may be adversely affected.
−Removed: Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
+Added: If our trademarks, trade dress, and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business, financial condition, results of operations, cash flows and prospects may be adversely affected.
+Added: Our trademarks, trade dress, or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names or marks which we need for name recognition by potential partners or customers in our markets of interest.
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Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings.
−Removed: If we are unable to establish name recognition based on our trademarks and trade names, we may not
−Removed: be able to compete effectively and our business, financial condition, results of operations, cash flows and prospects may be adversely affected.
+Added: If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business, financial condition, results of operations, cash flows and prospects may be adversely affected.
Intellectual property rights do not necessarily address all potential threats.
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We may not be able to generate sufficient cash flow to service all of our indebtedness and may be forced to take other actions to satisfy our debt service obligations, which actions may not be adequate or may impose additional restrictions on us.
−Removed: Our ability to make scheduled debt service payments or to refinance outstanding debt obligations depends on our financial and operating performance, which is subject to prevailing economic, industry and competitive conditions and certain financial, business, economic and other factors beyond our control, including those discussed under “Risk Related to Our Business and Strategy” above.
+Added: Our ability to make scheduled debt service payments or to refinance outstanding debt obligations depends on our financial and operating performance, which is subject to prevailing economic, industry and competitive conditions and certain financial, business, economic and other factors beyond our control, including those discussed under “ Risks Related to Our Business and Strategy ” above.
We may not be able to maintain a sufficient level of cash flow from operating activities to permit us to pay the principal, premium, if any, and interest on our indebtedness.
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Due to the uncertainty of various factors, we cannot estimate the likely tax benefits we may realize as a result of our purchase of LLC Units in Topco LLC (the “LLC Units”) and LLC Unit exchanges, and the resulting amounts we are likely to pay out to LLC Unitholders pursuant to the Tax Receivable Agreement;
−Removed: however, we estimate that such payments may be substantial.
+Added: however, such payments may be substantial.
Under the LLC Operating Agreement, tax distributions shall be made on a pro rata basis among the LLC Unitholders, and will be calculated without regard to any applicable basis adjustment under Section 743(b) of The Internal Revenue Code (“the Code”).
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federal income tax purposes as a result of the tax attributes subject to the Tax Receivable Agreement.
−Removed: result, payments could be made under the Tax Receivable Agreement in excess of the tax savings we realize in respect of the attributes to which the Tax Receivable Agreement relate.
+Added: As a result, payments could be made under the Tax Receivable Agreement in excess of the tax savings we realize in respect of the attributes to which the Tax Receivable Agreement relate.
Conflicts of interest could arise between our shareholders and Maravai Life Sciences Holdings, LLC (“MLSH 1”), which may impede business decisions that could benefit our shareholders.
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These conflicts may result in decisions that are not in the best interests of shareholders.
−Removed: The Tax Receivable Agreement requires us to make cash payments to MLSH 1 and MLSH 2 in respect of certain tax benefits to which we may become entitled, and we expect that the payments we will be required to make will be substantial.
−Removed: 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 10 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.
+Added: The Tax Receivable Agreement requires us to make cash payments to MLSH 1 and MLSH 2 in respect of certain tax benefits to which we may become entitled, and we expect that the payments we may be required to make could be substantial.
+Added: 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
+Added: 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.
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The payments under the Tax Receivable Agreement are also not conditioned upon MLSH 1 maintaining a continued ownership interest in Topco LLC.
+Added: Estimating the amount and timing of our realization of tax benefits subject to the Tax Receivable Agreement is by its nature imprecise.
The actual amount and timing of any payments under the Tax Receivable Agreement will vary depending upon a number of factors, including the timing of exchanges by MLSH 1, the amount of gain recognized by MLSH 1, the amount and timing of the taxable income we generate in the future and the federal tax rates then applicable.
−Removed: We expect that the aggregate payments that we may make under the Tax Receivable Agreement will be substantial.
−Removed: Assuming no material changes in the relevant tax law, and that we earn sufficient taxable income to realize all tax benefits that are subject to the Tax Receivable Agreement, we expect that future payments under the Tax Receivable Agreement relating to the purchase by Maravai LifeSciences Holdings, Inc.
−Removed: of LLC Units from MLSH 1 to be approximately $718.2 million and to range from approximately $42.3 million to $63.3 million per year over the next 14 years and decline thereafter.
−Removed: As a result, we expect that aggregate payments under the Tax Receivable Agreement over this 14-year period will be approximately $681.7 million.
−Removed: Future payments in respect of subsequent exchanges or financing would be in addition to these amounts and are expected to be substantial.
+Added: Accordingly, estimating the amount and timing of payments that may become due under the Tax Receivable Agreement is also by its nature imprecise.
+Added: We expect that the aggregate payments that we may be required to make under the Tax Receivable Agreement may be substantial.
+Added: Assuming no material changes in the relevant tax law, we expect that probable future payments under the Tax Receivable Agreement relating to the purchase by Maravai LifeSciences Holdings, Inc.
+Added: of LLC Units from MLSH 1 and the corresponding tax attributes to be approximately $7.1 million.
+Added: This determination is based on our estimate of taxable income for the year ended December 31, 2023.
+Added: Future payments in respect of subsequent exchanges or financings and tax attributes relating to the purchase by the Company of LLC Units from MLSH 1 would be in addition to this amount and may be substantial.
The foregoing numbers are merely estimates—the actual payments could differ materially.
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Although we are not aware of any issue that would cause the Internal Revenue Service (“IRS”) to challenge a tax basis increase or the availability of tax attributes of the corporations merged into our corporate structure as part of the Organizational Transactions, if any, we will not be reimbursed for any cash payments previously made to MLSH 1 and MLSH 2 pursuant to the Tax Receivable Agreement if any tax benefits initially claimed by us are subsequently disallowed, in whole or in part, by the IRS or other applicable taxing authority.
−Removed: For example, if the IRS later asserts that we did not obtain a tax basis increase or disallows (in whole or in part) the availability of Net Operating Losses (“NOLs”) due to a potential ownership change under Section 382 of the Internal Revenue Code (“IRC” or “the Code”), among other potential challenges, then we would not be reimbursed for any cash payments previously made to MLSH 1 and MLSH 2 pursuant to the Tax Receivable Agreement with respect to such tax
−Removed: benefits that we had initially claimed.
+Added: For example, if the IRS later asserts that we did not obtain a tax basis increase or disallows (in whole or in part) the availability of Net Operating Losses (“NOLs”) due to a potential ownership change under Section 382 of the Internal Revenue Code (“IRC” or “the Code”), among other potential challenges, then we would not be reimbursed for any cash payments previously made to MLSH 1 and MLSH 2 pursuant to the Tax Receivable Agreement with respect to such tax benefits that we had initially claimed.
Instead, any excess cash payments made by us pursuant to the Tax Receivable Agreement will be netted against any future cash payments that we might otherwise be required to make under the terms of the Tax Receivable Agreement.
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As a result, it is possible that we could make cash payments under the Tax Receivable Agreement that are substantially greater than our actual cash tax savings.
+Added: The Tax Receivable Agreement liability is recorded on the consolidated balance sheets as a contingent liability under ASC 450, “Liabilities,” and reflects management’s assessment that positive future taxable income and realization of cash tax savings are probable.
+Added: Management’s assessment of whether payment of the Tax Receivable Agreement liability is probable is generally based on the determination as to whether it is more likely than not that the deferred tax assets will be realized.
+Added: We evaluate the realizability of our deferred tax assets on a quarterly basis and establish valuation allowances when it is more likely than not that all or a portion of a deferred tax asset may not be realized.
+Added: As of December 31, 2023, we established a full valuation allowance against our deferred tax assets and derecognized the remaining non-current liability under the Tax Receivable Agreement after concluding it was not probable that we would generate sufficient future taxable income to utilize deferred tax assets that would result in payments due under the Tax Receivable Agreement.
+Added: If revised forecasts of our future taxable income or other relevant factors result in us releasing all or a portion of the valuation allowance recorded against the deferred tax assets applicable to the aforementioned tax attributes in a future period, the remaining Tax Receivable Agreement liability may be
+Added: considered probable at that time and recorded on the consolidated balance sheet and within earnings.
+Added: It is impossible to predict when and to what extent, if at all, such valuation allowance will be released, and therefore whether we would again be required to recognize all or a portion of the Tax Receivable Agreement liability, which would adversely impact our future results of operations, possibly in a material manner.
Under the Tax Receivable Agreement, we are required to provide MLSH 1 and MLSH 2 with a schedule setting forth the calculation of payments that are due under the TRA with respect to each taxable year in which a payment obligation arises within ninety (90) days after the extended due date of our U.S.
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The calculation will become final thirty (30) days after it is provided assuming that no objections are made.
−Removed: Payments under the Tax Receivable Agreement will generally be made within five (5) business days after this schedule becomes final pursuant to the procedures set forth in the Tax Receivable Agreement, although interest on such payments will begin to accrue at a rate of Intercontinental Exchange London Interbank Offer Rate (“LIBOR”) for a period of one month (or, if LIBOR ceases to be published, at a rate selected by us in good faith, with characteristics similar to LIBOR or consistent with market practices generally, any such rate, a “Replacement Rate”) plus 100 basis points from the due date (without extensions) of such tax return.
+Added: Payments under the Tax Receivable Agreement will generally be made within five (5) business days after this schedule becomes final pursuant to the procedures set forth in the Tax Receivable Agreement.
+Added: Interest on such payments will begin to accrue at a rate of Intercontinental Exchange London Interbank Offer Rate (“LIBOR”) for a period of one month (or, if LIBOR ceases to be published, at a rate selected by us in good faith, with characteristics similar to LIBOR or consistent with market practices generally, any such rate, a “Replacement Rate”) plus 100 basis points from the due date (without extensions) of such tax return.
Generally, any late payments that may be made under the Tax Receivable Agreement will continue to accrue interest at LIBOR (or a Replacement Rate, as applicable) plus 500 basis points until such payments are made, including any late payments that we may subsequently make because we did not have enough available cash to satisfy our payment obligations at the time at which they originally arose.
+Added: Given the cessation of LIBOR, we have transitioned to the Secured Overnight Financing Rate (“SOFR”) as the applicable Replacement Rate as allowable under the Tax Receivable Agreement.
The amounts that we may be required to pay to MLSH 1 and MLSH 2 under the Tax Receivable Agreement may be accelerated in certain circumstances and may also significantly exceed the actual tax benefits that we ultimately realize.
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Our organizational structure, including the Tax Receivable Agreement, confers certain benefits upon MLSH 1, as the only other LLC Unitholder in Topco LLC, and MLSH 2 that will not benefit the other holders of our Class A common stock to the same extent.
−Removed: We have entered into a Tax Receivable Agreement with MLSH 1 and MLSH 2, which will provide for the payment by us to MLSH 1 and MLSH 2, collectively, of 85% of the amount of 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 of certain of the entities (the “Blocker Entities”) through which GTCR and other existing members of MLSH 1 and MLSH 2 held their ownership interests in MLSH 1, 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.
−Removed: Due to the uncertainty of various factors, we cannot estimate the likely tax benefits
−Removed: we will realize as a result of purchases of LLC Units and LLC Unit exchanges, and the resulting amounts we are likely to pay out to MLSH 1 and MLSH 2 pursuant to the Tax Receivable Agreement;
+Added: We have entered into a Tax Receivable Agreement with MLSH 1 and MLSH 2, which will provide for the payment by us to MLSH 1 and MLSH 2, collectively, of 85% of the amount of 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 of certain of the entities through which GTCR and other existing members of MLSH 1 and MLSH 2 held their ownership interests in MLSH 1, 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.
+Added: Due to the uncertainty of various factors, we cannot estimate the likely tax benefits we will realize as a result of purchases of LLC Units and LLC Unit exchanges, and the resulting amounts we are likely to pay out to MLSH 1 and MLSH 2 pursuant to the Tax Receivable Agreement;
however, we estimate that such payments may be substantial.
−Removed: Although we will retain 15% of the amount of such tax benefits, this and other aspects of our organizational structure may adversely impact the future trading market for the Class A common stock.
+Added: we will retain 15% of the amount of such tax benefits, this and other aspects of our organizational structure may adversely impact the future trading market for the Class A common stock.
We may not be able to realize all or a portion of the tax benefits that are currently expected to result from the tax attributes covered by the Tax Receivable Agreement and from payments made under the Tax Receivable Agreement.
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Our future effective tax rates could be subject to volatility or adversely affected by a number of factors, including:
−Removed: • changes in the valuation of our deferred tax assets and liabilities;
−Removed: • expected timing and amount of the release of any tax valuation allowances;
+Added: • changes in the amount and realizability of our deferred tax assets and liabilities;
+Added: • changes in any tax valuation allowances;
• expiration of, or detrimental changes in, research and development tax credit laws;
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Outcomes from these audits could have an adverse effect on our operating results and financial condition.
−Removed: If we were deemed to be an investment company under the Investment Company Act of 1940, as amended (the “1940 Act”), applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.
+Added: If we were deemed to be an investment company under the 1940 Act, applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.
Under Sections 3(a)(1)(A) and (C) of the 1940 Act, a company generally will be deemed to be an “investment company” for purposes of the 1940 Act if it (1) is, or holds itself out as being, engaged primarily, or proposes to engage primarily, in the business of investing, reinvesting or trading in securities or (2) is engaged, or proposes to engage, in the business of investing, reinvesting, owning, holding or trading in securities and it owns or proposes to acquire investment securities having a value exceeding 40% of the value of its total assets (exclusive of U.S.
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On that basis, we believe that our interest in Topco LLC is not an “investment security” under the 1940 Act.
−Removed: Therefore, we have less than 40% of the value of our
−Removed: total assets (exclusive of U.S.
−Removed: government securities and cash items) in “investment securities.” However, if we were to lose the right to manage and control Topco LLC, interests in Topco LLC could be deemed to be “investment securities” under the 1940 Act.
+Added: Therefore, we have less than 40% of the value of our total assets (exclusive of U.S.
+Added: government securities and cash items) in “investment securities.” However, if we were to lose the
+Added: right to manage and control Topco LLC, interests in Topco LLC could be deemed to be “investment securities” under the 1940 Act.
We intend to conduct our operations so that we will not be deemed to be an investment company.
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We are obligated to develop and maintain proper and effective internal control over financial reporting in order to comply with Section 404 of the Sarbanes-Oxley Act.
−Removed: We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be operating effectively, which may adversely affect investor confidence in us and, as a result, the value of our Class A common stock.
+Added: We may not complete our analysis of our internal control over financial reporting in a timely manner, or to the extent these internal controls are determined by us or our auditors to not be operating effectively, investor confidence in us and the value of our Class A common stock could be adversely affected.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting.
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Developing the system and processing documentation necessary to perform the evaluation needed to comply with Section 404 of the Sarbanes-Oxley Act is a costly and challenging process.
−Removed: If we are unable to assert that our internal control over financial reporting is effective, we could lose investor confidence in the accuracy and completeness of our financial reports, which could cause the price of our Class A common stock to decline, and we may be subject to investigation or sanctions by the SEC.
+Added: If we are unable to assert that our internal control over financial reporting is effective, investors could lose confidence in the accuracy and completeness of our financial reports, which could cause the price of our Class A common stock to decline, and we may be subject to investigation or sanctions by the SEC.
We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting.
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Our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our controls are documented, designed or operating, which could cause the price of our Class A common stock to decline, and we may be subject to investigation or sanctions by the SEC.
−Removed: Additionally, the existence of any material weakness or significant deficiency would require management to devote significant time and incur significant expense to remediate any such material weaknesses or significant deficiencies and management may not be able to remediate any such material weaknesses or significant deficiencies in a timely manner.
+Added: Additionally, the existence of a material weakness or significant deficiency would require management to devote significant time and incur significant expense to remediate any such material weaknesses or significant deficiencies and management may not be able to remediate any such material weaknesses or significant deficiencies in a timely manner.
The existence of any material weakness in our internal control over financial reporting could also result in errors in our financial statements that could require us to restate our financial statements, cause us to fail to meet our reporting obligations and cause shareholders to lose confidence in our reported financial information, all of which could materially and adversely affect our business and stock price.
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GTCR controls us, and its interests may conflict with ours or yours in the future.
−Removed: As of December 31, 2022, investment entities affiliated with GTCR collectively controlled approximately 57% of the voting power of our outstanding common stock and therefore GTCR controls the vote of all matters submitted to a vote of our shareholders.
+Added: As of December 31, 2023, investment entities affiliated with GTCR collectively controlled approximately 56% 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.
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We entered into a Director Nomination Agreement with GTCR that provides GTCR the right to nominate to the Board a number of designees equal to at least:
−Removed: (i) 100% of the total number of directors comprising the Board, so long as GTCR beneficially owns shares of Class A common stock and Class B common stock representing at least 40% of the total amount of shares of Class A common stock and Class B common stock it beneficially owned as of November 19, 2020, (ii) 40% of the total number of directors, in the event that GTCR beneficially owns shares of Class A common stock and Class B common stock representing at least 30% but less than 40% of the total amount of shares of Class A common stock and Class B common stock it owned as of November 19, 2020, (iii) 30% of the total number of directors, in the event that GTCR beneficially owns shares of Class A common stock and Class B common stock representing at least 20% but less than 30% of the total amount of shares of Class A common stock and Class B common stock it owned as of November 19, 2020, (iv) 20% of the total number of directors, in the event that GTCR beneficially owns shares of Class A common stock and Class B common stock representing at least 10% but less than 20% of the total amount of shares of Class A common stock and Class B common stock it owns as of November 19, 2020 and (v) one director, in the event that GTCR beneficially owns shares of Class A common stock and Class B common stock representing at least 5% of the total amount of shares of Class A common stock and Class B common stock it owned as of November 19, 2020.
+Added: (i) 100% of the total number of directors comprising the Board, so long as GTCR
+Added: beneficially owns shares of Class A common stock and Class B common stock representing at least 40% of the total amount of shares of Class A common stock and Class B common stock it beneficially owned as of November 19, 2020, (ii) 40% of the total number of directors, in the event that GTCR beneficially owns shares of Class A common stock and Class B common stock representing at least 30% but less than 40% of the total amount of shares of Class A common stock and Class B common stock it owned as of November 19, 2020, (iii) 30% of the total number of directors, in the event that GTCR beneficially owns shares of Class A common stock and Class B common stock representing at least 20% but less than 30% of the total amount of shares of Class A common stock and Class B common stock it owned as of November 19, 2020, (iv) 20% of the total number of directors, in the event that GTCR beneficially owns shares of Class A common stock and Class B common stock representing at least 10% but less than 20% of the total amount of shares of Class A common stock and Class B common stock it owns as of November 19, 2020 and (v) one director, in the event that GTCR beneficially owns shares of Class A common stock and Class B common stock representing at least 5% of the total amount of shares of Class A common stock and Class B common stock it owned as of November 19, 2020.
The Director Nomination Agreement provides that GTCR may assign such right to a GTCR affiliate.
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You will not have the same protections as those afforded to shareholders of companies that are subject to such governance requirements.
−Removed: GTCR controls a majority of the voting power of our outstanding common stock.
−Removed: As a result, we are a “controlled company” within the meaning of the corporate governance standards of NASDAQ.
−Removed: Under these rules, a company of which more than 50% of the voting power for the election of directors is held by an individual, group or another company is a “controlled company” and may elect not to comply with certain corporate governance requirements, including:
−Removed: • the requirement that a majority of our Board consist of independent directors;
−Removed: • the requirement that we have a nominating and corporate governance committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities;
−Removed: • the requirement that we have a compensation committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities;
−Removed: • the requirement for an annual performance evaluation of the nominating and corporate governance and compensation committees.
−Removed: We utilize these exceptions and do not have a majority of independent directors on our Board, our compensation and nominating committee does not consist entirely of independent directors and is not subject to annual performance evaluations, and we do not have a corporate governance committee.
−Removed: Accordingly, you will not have the same protections afforded to shareholders of companies that are subject to all of the corporate governance requirements of NASDAQ.
+Added: Currently, GTCR controls a majority of the voting power of our outstanding common stock.
+Added: As a result, we are a “controlled company” within the meaning of the corporate governance requirements of NASDAQ.
+Added: Under these rules, a company of which more than 50% of the voting power for the election of directors is held by an individual, group or another company is a “controlled company” and may elect not to comply with certain corporate governance requirements of NASDAQ, including:
+Added: • the requirement that a majority of our Board is composed of “independent directors” as defined under NASDAQ rules;
+Added: • the requirement that we have a nominations committee that is composed entirely of independent directors;
+Added: • the requirement that we have a compensation committee that is composed entirely of independent directors.
+Added: From time to time, we may rely on these exceptions.
+Added: Although a majority of our Board is currently composed of independent directors, neither our Compensation and Leadership Development Committee, nor our Nominating, Governance and Risk Committee, consists entirely of independent directors.
+Added: Accordingly, you may not have the same protections afforded to shareholders of companies that are subject to all of the corporate governance requirements of NASDAQ.
Provisions of our corporate governance documents could make an acquisition of us more difficult and may prevent attempts by our shareholders to replace or remove our current management, even if beneficial to our shareholders.
3 unchanged sentences
• these provisions provide for a classified board of directors with staggered three-year terms;
−Removed: • these provisions provide that, at any time when GTCR controls, in the aggregate, less than 40% of the outstanding shares of our Class A common stock, directors may only be removed for cause, and only by the affirmative vote of holders of at least 66 2⁄3% in voting power of all the then-outstanding shares of our stock entitled to vote thereon, voting together as a single class;
+Added: • these provisions provide that, at any time when GTCR controls, in the aggregate, less than 40% of the outstanding shares of our Class A common stock, directors may only be removed for cause, and only by the affirmative vote of
+Added: holders of at least 66 2⁄3% in voting power of all the then-outstanding shares of our stock entitled to vote thereon, voting together as a single class;
• these provisions prohibit shareholder action by written consent from and after the date on which GTCR controls, in the aggregate, less than 35% in voting power of our stock entitled to vote generally in the election of directors;
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Our certificate of incorporation designates the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation that may be initiated by our shareholders and the federal district courts of the United States as the exclusive forum for litigation arising under the Securities Act, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us.
−Removed: Pursuant to our certificate of incorporation, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for any claims in state court for (1) any derivative action or proceeding brought on our behalf, (2) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our shareholders, (3) any action asserting a claim against us arising pursuant to any provision of the DGCL, our certificate of incorporation or our bylaws or (4) any other action asserting a claim against us that is
−Removed: governed by the internal affairs doctrine;
−Removed: provided that for the avoidance of doubt, the forum selection provision that identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation, including any “derivative action,” will not apply to suits to enforce a duty or liability created by the Securities Act, the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.
+Added: Pursuant to our certificate of incorporation, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware is the sole and exclusive forum for any claims in state court for (1) any derivative action or proceeding brought on our behalf, (2) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our shareholders, (3) any action asserting a claim against us arising pursuant to any provision of the DGCL, our certificate of incorporation or our bylaws or (4) any other action asserting a claim against us that is governed by the internal affairs doctrine;
+Added: provided that for the avoidance of doubt, the forum selection provision that identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation, including any “derivative action,” will not apply to suits to enforce a duty or liability created by the Securities Act of 1933, as amended (the “Securities Act”), the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or any other claim for which the federal courts have exclusive jurisdiction.
Our certificate of incorporation also provides that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.
2 unchanged sentences
If the enforceability of our forum selection provisions were to be challenged, we may incur additional costs associated with resolving such challenge.
−Removed: While we currently have no basis to expect any such challenge would be successful, if a court were to find our forum selection provisions to be inapplicable or unenforceable with respect to one or more of these specified types of actions or proceedings, we may incur additional costs associated with having to litigate in other jurisdictions, which could have an adverse effect on our business, financial condition, results of operations, cash flows and prospects and result in a diversion of the time and resources of our employees, management and board of directors.
−Removed: Our operating results and stock price may be volatile.
−Removed: Our quarterly operating results are likely to fluctuate in the future.
−Removed: In addition, securities markets worldwide have experienced, and are likely to continue to experience, significant price and volume fluctuations, including as a result of the current macroeconomic environment and fiscal and monetary policy uncertainty.
−Removed: This market volatility, as well as other general economic, market or political conditions, could subject the market price of our Class A common stock to wide price fluctuations regardless of our operating performance.
−Removed: Our operating results and the trading price of our Class A common stock may fluctuate in response to various factors, including those discussed throughout this section.
−Removed: A significant portion of our total outstanding shares of Class A common stock, including newly issued shares of Class A common stock issued upon the exchange of UP-C interests by MLSH 1, may be sold into the market in the near future.
−Removed: This could cause the market price of our Class A common stock to drop significantly, even if our business is doing well.
+Added: While we currently have no basis to expect any such challenge would be successful, if a court were to find our forum selection provisions to be
+Added: inapplicable or unenforceable with respect to one or more of these specified types of actions or proceedings, we may incur additional costs associated with having to litigate in other jurisdictions, which could have an adverse effect on our business, financial condition, results of operations, cash flows and prospects and result in a diversion of the time and resources of our employees, management and board of directors.
+Added: Our stock price may be volatile for reasons unrelated to our operating performance and financial condition.
+Added: Capital markets worldwide have experienced, and are likely to continue to experience, significant volatility, including as a result of the current challenging macroeconomic environment, fiscal and monetary policy uncertainty, as well as political instability and continued or worsening hostilities or military conflicts in certain regions.
+Added: This market volatility, as well as other general economic, market or political conditions, could subject the trading price of our Class A common stock to wide price fluctuations regardless of our underlying operating performance and financial position.
+Added: If our existing investors sell a significant portion of our total outstanding shares of Class A common stock, the market price of our Class A common stock could drop significantly, even if our business is doing well.
Sales of a substantial number of shares of our Class A common stock in the public market could occur at any time.
+Added: As of December 31, 2023, we had 132,227,632 outstanding shares of Class A common stock, 21,681,033 of which held by MLSH 2, and further, as of December 31, 2023, an additional 119,094,026 shares of Class A common stock are issuable upon the exchange by MLSH 1 of its interest in Topco.
+Added: 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.
+Added: federal securities laws.
+Added: 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.
−Removed: As of December 31, 2022, we had 131,691,863 outstanding shares of Class A common stock, 21,681,033 of which are subject to restrictions imposed by federal securities laws.
−Removed: All of these shares of Class A common stock could, however, be sold from time to time, subject to restrictions imposed by federal securities laws.
−Removed: We also register shares of Class A common stock that we issue under our equity compensation plans.
−Removed: Once we register these shares, they can be freely sold in the public market upon issuance.
−Removed: Further, as of December 31, 2022, an additional 123,669,196 shares of Class A common stock are issuable upon the exchange by MLSH 1 of its interest in Topco.
Because we have no current plans to pay regular cash dividends on our Class A common, you may not receive any return on investment unless you sell your Class A common stock for a price greater than that which you paid for it.
8 unchanged sentences
The potential issuance of preferred stock may delay or prevent a change in control of us, discouraging bids for our Class A common stock at a premium to the market price, and materially adversely affect the market price and the voting and other rights of the holders of our Class A common stock.
−Removed: Unresolved Staff Comments
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.