9 unchanged sentences
• The level of our customers’ spending on and demand for outsourced nucleic acid production and biologics safety testing products and services.
−Removed: • 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.
−Removed: • 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.
−Removed: • The effects of our recent reduction in force, including on our ability to attract and/or retain qualified key personnel.
+Added: • Our operating results are prone to significant fluctuation, which may make our future operating results difficult to predict and could cause our actual operating results to fall below expectations or any guidance we may provide.
+Added: • Uncertainty regarding the extent and duration of our revenue associated with high-volume sales of CleanCap® for commercial phase vaccine programs and the dependency of such revenue, in important respects, on factors outside our control.
+Added: • Shifts in the trade, economic and other policies and priorities of the U.S.
+Added: federal government on our and our customers’ current and future business operations.
+Added: • Our ability to attract, retain and motivate a highly skilled workforce.
• 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.
3 unchanged sentences
• Market acceptance of our life science reagents.
−Removed: • 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.
−Removed: • Our ability to implement our strategic plan successfully.
−Removed: • Natural disasters, geopolitical instability (including the ongoing military conflicts in Ukraine and the Gaza Strip) and other catastrophic events.
+Added: • Our ability to efficiently manage our strategic acquisitions and organic growth opportunities.
+Added: • Natural disasters, geopolitical instability (including the ongoing military conflicts in Ukraine and the Middle East) and other catastrophic events.
• Risks related to our acquisitions, including whether we achieve the anticipated benefits of acquisitions of businesses or technologies.
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• Our potential failure to meet our debt service obligations.
−Removed: • Restrictions on our current and future operations under the terms applicable to the Credit Agreement.
+Added: • Restrictions on our current and future operations under the terms applicable to our credit agreement.
Risks Related to Our Organizational Structure
7 unchanged sentences
Risks Related to Being a Public Company
−Removed: • 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 and uncertainty related to the restatement of our previously issued quarterly financial statements.
+Added: • Our ability to remediate the material weaknesses in our internal control over financial reporting in a timely manner.
+Added: • Our ability to design and maintain effective internal control over financial reporting in the future.
Risks Related to Our Class A Common Stock
−Removed: • 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: • The fact that investment entities affiliated with GTCR, LLC (“GTCR”) currently control a majority of the voting power of our outstanding common stock and may have interests that conflict with ours or yours in the future.
• Risks related to our “controlled company” status within the meaning of the corporate governance standards of NASDAQ.
1 unchanged sentence
• Potential sales of a significant portion of our outstanding shares of Class A common stock.
−Removed: • Potential preferred stock issuance and the anti-takeover impacts of any such issuances.
+Added: • Potential preferred stock issuances and the anti-takeover impacts of any such issuances.
Risks Related to Our Business and Strategy
7 unchanged sentences
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.
−Removed: 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.
−Removed: 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: Past declines and uncertainties in the capital markets, including as a result of ongoing macroeconomic challenges during 2023 and into 2024, including elevated interest rates and volatile credit markets, limited access to capital and negatively affected companies’ ability to fund research and development efforts due to a considerable contraction in the level of investment in venture- and private equity-backed startup companies and funding for companies at all stages, particularly early- and late-stage companies.
+Added: Notwithstanding ongoing liquidity challenges, global venture capital investment increased slightly in 2024, however, investments in information technology and artificial intelligence (“AI”) companies overshadowed other sector categories, with over twice the level of investment relative to the health and life sciences sector.
+Added: Lower levels of venture capital investment in the health and life sciences sector, together with hesitancy about a broader economic recovery, including as a result of geopolitical instability and actual and potential shifts in U.S.
+Added: and foreign trade, economic and other policies, has led certain of our customers to implement more stringent budgetary policies designed to conserve capital, which in turn, caused a reduction in research and development spending and a decline in further purchases of our products and services.
We have no assurance as to whether, or when, such research and development spending may stabilize or increase, if at all.
Further, if the funding of venture- and private equity-backed biotechnology and pharmaceutical companies remains weak or weakens further, the research and development budgets of our customers may be further reduced or eliminated altogether, which could impact future demand for our products and services.
−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.
+Added: If our customers maintain stringent budgetary policies or further 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.
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.
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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.
−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: Certain of our products, including our proprietary CleanCap® analogs, are used by our customers in the production of COVID-19 vaccines.
−Removed: 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: Our operating results are prone to significant fluctuations, which may make our future operating results difficult to predict and could cause our actual operating results to fall below expectations or any guidance we may provide.
+Added: We have no control over the timing and volume of purchases by our customers.
+Added: We estimate that revenue from high-volume sales of CleanCap® for commercial phase vaccine programs represented approximately 25.4%, 21.0% and 67.9% of our total revenues for the years ended December 31, 2024, 2023 and 2022, respectively.
+Added: The amount, timing and durability of future high-volume CleanCap® orders have become increasingly difficult to forecast because historical customers for such orders have been unable or unwilling to provide visibility into their anticipated future needs and plans to purchase CleanCap®.
+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, and if high-volume orders for CleanCap® do not materialize in the future at similar or greater levels than they have in the past, our revenues and cash flows will significantly decrease which, in turn, could have a material adverse impact on our future operating results and financial condition.
+Added: Fluctuations in our operating results may be driven by a variety of factors, many of which are outside of our control, including, but not limited to:
+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;
+Added: • our ability to increase penetration in our existing markets and expand into new markets;
+Added: • our customers accelerating, canceling, reducing or delaying orders as a result of developments related to their pre-clinical studies and clinical trials;
+Added: • the relative reliability and robustness of our products and services;
+Added: • changes in governmental regulations or the regulatory posture toward our business;
+Added: • the volume and mix of the products and services we sell;
+Added: • changes in the production or sales costs related to our products and services;
+Added: • the success of our newer products, such as our CleanCap® and mRNA products;
+Added: • the rate of introduction of other new products or product enhancements by us or others in our industry;
+Added: • the timing and amount of expenditures that we may incur to acquire, develop or commercialize additional products, services and technologies or for other purposes, such as the expansion of our facilities;
+Added: • changes in governmental and academic funding of life sciences research and developments or changes that impact budgets, budget cycles or seasonal spending patterns of our customers;
+Added: • future accounting pronouncements or changes in our accounting policies;
+Added: • 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;
+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;
+Added: • the other factors described in this “Risk Factors” section.
+Added: The impact of any one of the factors discussed above, or the cumulative effects of a combination of such factors, could result in significant fluctuations and unpredictability in our quarterly and annual operating results.
+Added: As a result, comparisons of our operating results on a period-to-period basis may not be meaningful.
+Added: Investors should not rely on our past results as an indication of our future performance.
+Added: As a result of variability and unpredictability, we may also fail to meet the expectations of industry or financial analysts or investors for any period.
+Added: If our revenue or operating results fall short of the expectations of analysts or investors or any guidance we may provide, or if the guidance we provide falls short of the expectations of analysts or investors, the price of our
+Added: Class A common stock could decline substantially.
+Added: Such a stock price decline could occur even when we have met or exceeded any previously publicly stated guidance we may have provided.
+Added: The extent and duration of our revenue associated with high-volume sales of CleanCap® for commercial phase vaccine programs are uncertain and are dependent, in important respects, on factors outside our control.
+Added: Certain of our products, including our proprietary CleanCap® analogs, are used by our customers in the production of commercial phase vaccines, notably COVID-19 vaccines.
+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 high-volume sales of our proprietary Cle anCap® ana logs and highly modified RNA products, particularly mRNA, for commercial vaccines.
However, as a result of the general decrease in market demand for COVID-19 related products and services, including the supply and manufacture of COVID-19 vaccines, and in particular, following the end of U.S.
−Removed: 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.
−Removed: 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: We expect to experience
−Removed: 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.
−Removed: 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.
−Removed: Our longer-term revenue prospects for COVID-19 related products are highly uncertain but are expected to be substantially less than pandemic highs.
+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 high-volume orders for CleanCap®.
+Added: For the years ended December 31, 2024, 2023 and 2022, we estimate that revenue from high-volume sales of CleanCap® for commercial phase vaccine programs and related services represented approximately 25.4%, 21.0% and 67.9%, respectively, of our total revenues.
+Added: We expect to experience further declines in high-volume sales of CleanCap® for the aforementioned reasons, as well as a result of unused inventory of our products that our customers have on hand, which are not indication-specific.
+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 CleanCap® analogs for commercial phase vaccine production, if at all.
+Added: Our longer-term revenue prospects for high-volume CleanCap® orders are highly uncertain but are expected to remain substantially lower than pandemic highs.
Additionally, the ongoing manufacture and supply of COVID-19 vaccines (including bivalent booster doses) by our customers is uncertain and subject to various political, social, economic, and regulatory factors that are outside of our control, including the emergence, duration and intensity of new virus variants;
2 unchanged sentences
competition faced by our customers from other COVID-19 vaccine manufacturers and the development and availability of antiviral therapeutic alternatives;
−Removed: 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;
political and social debate relating to the need for, efficacy of, or side effects related to one or more specific COVID-19 vaccines;
−Removed: economy and global economy, including impacts resulting from supply chain constraints, labor market shortages and inflationary pressures.
−Removed: 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: 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.
+Added: the politicization of vaccinations and increase in vaccine skepticism;
+Added: economy and global economy.
+Added: As the supply and manufacture of COVID-19 vaccines by our customers slows, or becomes no longer necessary, including if COVID-19 vaccines by our customers’ competitors are determined or perceived to be more effective, we expect that demand for high-volume sales of CleanCap® will continue to significantly decrease, which would have a material adverse effect on our revenue, results of operations and financial condition.
+Added: Shifts in the trade, economic and other policies and priorities of the U.S.
+Added: federal government 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.
−Removed: Research and development spending by our customers and the availability of government research funding can fluctuate due to changes in available resources, mergers of pharmaceutical and biotechnology companies, spending priorities, general economic conditions and institutional and governmental budgetary policies.
+Added: Research and development spending by our customers and the availability of government research funding can fluctuate due to changes in available resources, institutional and governmental budgetary policies, mergers of pharmaceutical and biotechnology companies, spending priorities, and general economic conditions.
Our biologics safety testing customers are biopharmaceutical companies, contract research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”) and life science companies, which largely serve the biopharmaceutical industry.
Our nucleic acid production customers are largely vaccine and therapeutic drug makers or diagnostics manufacturers, which rely in part on government healthcare-related policies and funding.
−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 ongoing appropriations process for the US.
−Removed: 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.
−Removed: In particular, if the U.S.
−Removed: 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.
−Removed: Department of Defense may be jeopardized, which would negatively affect our business, operations and financial condition.
−Removed: Currently, the U.S.
−Removed: 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.
−Removed: 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.
−Removed: In particular, labor shortages and wage inflation have affected our ability to hire, develop and retain our talented and diverse workforce, to maintain performance levels (especially cost and schedule), and to maintain our corporate culture.
−Removed: Further, if our raw material and other laboratory material suppliers experience operational challenges as a result of labor shortages, limited material availability, logistics delays and transportation capacity constraints, or are unable to access adequate capital to support their working capital requirements, they may be unable to provide raw materials or other laboratory materials to us in a timely manner or at a reasonable cost, which could adversely affect our profit margins and results of operations.
−Removed: Additionally, demand for our products and services could be adversely impacted if these ongoing macroeconomic challenges cause customers to reduce their operating budgets, adversely impact our customers’ ability to commit funds to purchase our products, or otherwise cause customers to delay, cancel, decrease or forego purchases of our products and services.
+Added: As a result, changes in government funding for certain research, decreases in or the imposition of limits on government spending more generally (including if the Office of Management and Budget reenacts its call for a freeze on payments for federal grants), skepticism of or hostility to mRNA as a modality, or reductions in overall healthcare spending could negatively impact us or our customers and, correspondingly, our sales to them, which would negatively affect our business, operations and financial condition.
+Added: Additionally, demand for our products and services could be adversely impacted if changes in U.S.
+Added: federal budgetary policy or actual and potential shifts in U.S.
+Added: and foreign trade policy, including the imposition (or threatened imposition) of tariffs, trade restrictions or potential retaliatory actions, cause customers to reduce their operating budgets, adversely impact our customers’ ability to commit funds to purchase our products, or otherwise cause customers to delay, cancel, decrease or forego purchases of our products and services.
Further, since the majority of our customers’ contracts can be terminated, delayed or reduced in scope upon short notice or no notice, this may require us to carry excess inventory to manage through unevenness in order activity and lead to unanticipated fluctuations in our quarterly revenue and earnings.
If we are not able to forecast and adequately manage through changes in our customers’ order requirements, our productivity, profitability, results of operations, cash flows and financial position could be negatively impacted.
−Removed: 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
−Removed: 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.
−Removed: 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.
−Removed: On November 7, 2023, we announced a workforce reduction of approximately 15% of our total full-time workforce (the “Reduction in Force”).
−Removed: The Reduction in Force resulted in the elimination of 102 full-time positions.
−Removed: 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.
−Removed: 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.
−Removed: Any such inefficiencies may cause disruption or delay in our business activities.
−Removed: 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.
−Removed: 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: A significant reduction or delay in governmental funding as a result of changes to U.S.
+Added: federal budgetary policy, or the perception that a shift in budgetary policy may occur, could cause a
+Added: decline in demand for our products and services and adversely affect our performance and result in declines in our revenue and earnings.
+Added: Our ability to develop and market our products and services and our overall performance depends on our ability to attract, retain and motivate a highly skilled workforce.
+Added: 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.
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.
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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 remained following the recovery and which we expect will continue beyond the near-term.
−Removed: These difficulties may be heightened as a result of the Reduction in Force.
+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.
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.
5 unchanged sentences
Following the release of nucleic acid COVID-19 vaccines, including those that incorporate our CleanCap® products, segments of the population have criticized their safety and efficacy impacting vaccine demand.
−Removed: In addition, ethical, social, legal and financial concerns about gene therapy and nucleic acid vaccines, including COVID-19 vaccines, could result in additional regulations or limitations or even prohibitions on certain gene therapies or vaccine-related products.
+Added: In addition, ethical, social, legal and financial concerns about gene therapy and nucleic acid vaccines, including COVID-19 vaccines, and more recent vaccine skepticism trends, notwithstanding medical evidence about their effectiveness, could result in additional regulations or limitations or even prohibitions on certain gene therapies or certain vaccine-related products.
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.
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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
−Removed: advanced technologies become available.
+Added: We also expect increased competition as additional companies enter our market and as more advanced technologies become available.
We compete with other providers of outsourced biologics products and services.
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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,
−Removed: 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, 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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In the event we, or our suppliers, produce products that fail to comply with required quality standards, we may incur delays in fulfilling orders, write-downs, damages resulting from product liability claims and harm to our reputation.
−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: We have no control over the timing and volume of purchases by our customers.
−Removed: 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.
−Removed: These fluctuations may be driven by a variety of factors, many of which are outside of our control, including, but not limited to:
−Removed: • 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;
−Removed: • 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;
−Removed: • our ability to increase penetration in our existing markets and expand into new markets;
−Removed: • our customers accelerating, canceling, reducing or delaying orders as a result of developments related to their pre-clinical studies and clinical trials;
−Removed: • the relative reliability and robustness of our products and services;
−Removed: • changes in governmental regulations or the regulatory posture toward our business;
−Removed: • the volume and mix of the products and services we sell;
−Removed: • changes in the production or sales costs related to our products and services;
−Removed: • the ongoing success of our newer products, such as our CleanCap® and mRNA products;
−Removed: • the rate of introduction of other new products or product enhancements by us or others in our industry;
−Removed: • the timing and amount of expenditures that we may incur to acquire, develop or commercialize additional products, services and technologies or for other purposes, such as the expansion of our facilities;
−Removed: • changes in governmental and academic funding of life sciences research and developments or changes that impact budgets, budget cycles or seasonal spending patterns of our customers;
−Removed: • future accounting pronouncements or changes in our accounting policies;
−Removed: • 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: • the timing and magnitude of any adjustments to the Tax Receivable Agreement liability;
−Removed: • changes in the assessment of the realizability of our deferred tax assets;
−Removed: • 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;
−Removed: • the other factors described in this “Risk Factors” section.
−Removed: The impact of any one of the factors discussed above, or the cumulative effects of a combination of such factors, could result in significant fluctuations and unpredictability in our quarterly and annual operating results.
−Removed: As a result, comparisons of our operating results on a period-to-period basis may not be meaningful.
−Removed: Investors should not rely on our past results as an indication of our future performance.
−Removed: As a result of variability and unpredictability, we may also fail to meet the expectations of industry or financial analysts or investors for any period.
−Removed: If our revenue or operating results fall short of the expectations of analysts or investors or any guidance we may provide, or if the guidance we provide falls short of the expectations of analysts or investors, the price of our Class A common stock could decline substantially.
−Removed: Such a stock price decline could occur even when we have met or exceeded any previously publicly stated guidance we may have provided.
If we are unable to manufacture in specific quantities, our operating results will be harmed.
7 unchanged sentences
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 (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.
+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 Middle East), terrorist attacks and other hostile acts, public health issues, epidemics or pandemics and other events beyond our control and the control of the third parties on which we depend.
Any of these catastrophic events, whether in the United States or abroad, may have a significant negative impact on the global economy, our employees, facilities, partners, suppliers, distributors or customers, and could decrease demand for our products and services, create delays and inefficiencies in our supply chain and make it difficult or impossible for us to deliver products and services to our customers.
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
−Removed: 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.
+Added: Any significant disruption of those operations for any reason, such as 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
+Added: 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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The market may not be receptive to our new products and services upon their introduction.
−Removed: We expect a portion of our future revenue growth to come from introducing new products, including plasmid DNA and GMP-grade mRNA.
+Added: We expect a portion of our future revenue growth to come from introducing new products, including discovery mRNA offerings and IVT enzyme offerings.
The commercial success of all of our products and services will depend upon their acceptance by the life science and biopharmaceutical industries.
Some of the products and services that we are developing are based upon new technologies or approaches.
−Removed: As a result, there can be no assurance that these new products and services, even if successfully developed and
−Removed: introduced, will be accepted by customers.
−Removed: 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.
+Added: 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: If customers do not adopt our new products, services
+Added: and technologies, our results of operations may suffer and, as a result, the market price of our Class A common stock may decline.
It may be difficult for us to implement our strategies for revenue growth in light of competitive challenges.
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Any product liability claim brought against us, with or without merit, could increase our insurance rates or prevent us from securing insurance coverage in the future.
−Removed: We may be unable to efficiently manage growth as a larger and more geographically diverse organization.
−Removed: Our strategic acquisitions, the continued expansion of our commercial sales operations and our organic growth have increased the scope and complexity of our business.
+Added: We may be unable to efficiently manage growth opportunities as a larger and more geographically diverse organization.
+Added: Our strategic acquisitions, the continued expansion of our commercial sales operations and our organic growth opportunities have increased the scope and complexity of our business.
As a result, we will face challenges inherent in efficiently managing a more complex business with an increased number of employees over large geographic distances, including the need to implement appropriate systems, policies, benefits and compliance programs.
−Removed: Our inability to manage successfully the geographically more diverse and substantially larger combined organization could materially adversely affect our operating results.
+Added: Our inability to manage successfully a geographically more diverse and substantially larger organization could materially adversely affect our operating results.
Opportunistic acquisitions may pose risks and challenges that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies.
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 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 2023, we completed the acquisition of Alphazyme, LLC, an original equipment manufacturer provider of custom molecular biology enzymes, servicing customers in the genetic analysis and nucleic acid synthesis markets to complement our nucleic acid production business, in January 2025, we acquired the intellectual property and related assets of Molecular Assemblies, Inc., developers of enzymatic DNA synthesis technology to complement our nucleic acid production business, and in February 2025, we completed the acquisition of Officinae Bio, S.R.L., a technology company with a proprietary digital platform designed with AI and machine learning capabilities to support the biological design of therapeutics to complement our nucleic acid production business.
However, we may be unable to continue to identify or complete promising acquisitions for many reasons, including competition among buyers, the high valuations of businesses in our industry, the need for regulatory and other approvals and the availability of capital, particularly during a period of disruption and volatility within the global capital and credit markets.
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As such, we may not be able to realize a tax benefit from the use of our NOLs .
−Removed: We may be required to record a significant charge to earnings if our goodwill and other amortizable intangible assets, or other investments become impaired.
+Added: We may be required to record a significant charge to earnings if our goodwill and other amortizable intangible assets, or other investments become impaired in the future.
We are required under U.S.
generally accepted accounting principles (“GAAP”) to test goodwill for impairment at least annually and to review our goodwill, amortizable intangible assets and other assets acquired through merger and acquisition activity for impairment when events or changes in circumstance indicate the carrying value may not be recoverable.
+Added: In assessing fair value, we make estimates and assumptions about sales, operating margins, growth rates, and discount rates based on our business plans, economic projections, anticipated future cash flows and marketplace data.
+Added: There are inherent uncertainties related to these factors and management’s judgment in applying these factors.
Factors that could lead to impairment of goodwill, amortizable intangible assets and other assets acquired via acquisitions include significant adverse changes in the business climate and actual or projected operating results (affecting our company as a whole or affecting any particular segment) and declines in the financial condition of our business.
−Removed: We may be required in the future to record additional charges to earnings if our goodwill, amortizable intangible assets or other investments become impaired.
−Removed: Any such charge would adversely impact our consolidated financial results.
+Added: For example, in connection with preparing our financial statements for the quarter ended September 30, 2024 and December 31, 2024, we identified certain indicators of
+Added: impairment and recorded a goodwill impairment of $154.2 million related to the TriLink reporting unit and of $11.9 million related to the Alphazyme reporting unit, respectively, both within our nucleic acid production segment.
+Added: We continue to foresee challenges in the market and economy that could adversely impact our operations and to the extent that forward-looking sales and operating assumptions are not achieved and are subsequently reduced, additional impairment charges may result.
+Added: Changes in the numerous variables associated with the judgments, assumptions and estimates we make, in assessing the appropriate valuation of our goodwill and other intangible assets of our reporting units, could in the future require us to record additional charges to earnings if our goodwill, amortizable intangible assets or other investments become impaired.
+Added: Any such charge would adversely impact our consolidated financial results, and may cause a decline in our stock price.
Changes in accounting principles and guidance could result in unfavorable accounting charges or effects.
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In some instances, we could reasonably use different estimates and assumptions, and changes in estimates may occur from period to period.
−Removed: See Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates—Revenue Recognition.”
Given the foregoing factors, comparing our revenue and operating results on a period-to-period basis may not be meaningful, and our past results may not be indicative of our future performance.
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In addition, the termination of these relationships, including following any failure to renew a long-term contract, could result in a temporary or permanent loss of revenue.
−Removed: See also “— 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.”
+Added: See also “— The extent and duration of our revenue associated with high-volume sales of CleanCap® for commercial phase vaccine programs is uncertain and are dependent, in important respects, on factors outside our control.”
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
−Removed: potential commercial opportunities on an ongoing basis, which can be time consuming.
+Added: We engage in conversations with other companies and institutions regarding 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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Delays or difficulties in securing these raw materials or other laboratory materials could result in an interruption in our production operations if we cannot obtain an acceptable substitute.
−Removed: Since the onset of the COVID-19 pandemic, global supply chains have faced challenges, including material availability, global logistics delays and constraints arising from, among other things, the transportation capacity of ocean shipping containers, and these challenges have been exacerbated by the ongoing macroeconomic conditions as discussed above.
+Added: In recent years, global supply chains have faced challenges, including material availability, global logistics delays and constraints arising from, among other things, the transportation capacity of ocean shipping containers.
+Added: More recently, geopolitical instability and U.S.
+Added: foreign trade policy, including the imposition or threatened imposition of tariffs or other trade restrictions, could increase macroeconomic uncertainty at a global level and lead to supply chain constraints and delays.
Any interruption of our supply chain could significantly affect our business, financial condition, results of operations, cash flows and prospects.
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Our operations depend upon our ability to obtain raw materials at reasonable prices.
−Removed: Cost and wage inflation, ongoing supply disruptions and logistics capacity constraints have increased, or may increase, our costs to manufacture and distribute our products and services.
+Added: Cost and wage inflation, supply disruptions and logistics capacity constraints have increased in the past, or may increase in the future, our costs to manufacture and distribute our products and services.
If we are unable to obtain the materials we need at a reasonable price due to inflationary pressures or other factors, we may not be able to produce certain of our products at marketable prices or at all, which could have a material adverse effect on our results of operations.
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If the supply of raw materials is interrupted, due to ongoing supply chain disruptions or other factors, our business, financial condition, results of operations, cash flows and prospects may be adversely affected.
−Removed: Because we rely heavily on third-party package-delivery services, a significant disruption in these services, damages or losses sustained during shipping or significant increases in prices could adversely affect our business, financial condition, results of operations, cash flows and prospects.
+Added: Because we rely heavily on third-party package-delivery services, a significant disruption in these services, damages or losses sustained during shipping or significant increases in shipping costs could adversely affect our business, financial condition, results of operations, cash flows and prospects.
We ship a significant portion of our products to our customers through independent package delivery companies, such as World Courier, FedEx, UPS and DHL.
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Failure to comply with any of these laws and regulations could result in enforcement action against us, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.
−Removed: Additionally, if we are unable to properly protect the privacy and security of personal information, we could be found to have breached our contracts.
+Added: Additionally, if we
+Added: are unable to properly protect the privacy and security of personal information, we could be found to have breached our contracts.
Many states in which we operate have laws that protect the privacy and security of personal information.
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federal, U.S.
−Removed: state, and/or international data
−Removed: breach notification laws and regulations.
+Added: state, and/or international data 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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and international healthcare industry is subject to changing political, economic and regulatory influences that could significantly affect the drug development process, research and development costs and the pricing and reimbursement for pharmaceutical products, and also may increase the likelihood of legislative or regulatory changes that could impact us or our business operations.
−Removed: Any significant change in regulations could have an adverse effect on both our customers’ business and our business, which could result in reduced demand for our products and services or increases in our expenses.
+Added: Any significant change in
+Added: regulations could have an adverse effect on both our customers’ business and our business, which could result in reduced demand for our products and services or increases in our expenses.
For example, we provide products and services used for basic research, raw materials used by biopharmaceutical customers for further processing, and active pharmaceutical ingredients used for preclinical studies and clinical trials.
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In addition, one of our strategies is to expand geographically, both through distribution and through direct sales.
−Removed: This subjects us to a number of risks, including international economic, political, and labor conditions;
+Added: This subjects us to a number of risks, including international economic, geopolitical, and labor conditions;
currency fluctuations;
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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
−Removed: certain technology;
−Removed: tariffs, quotas and other trade barriers and restrictions;
+Added: delays resulting from difficulty in obtaining export licenses for certain technology;
+Added: new or increased tariffs (or potential retaliatory actions taken in response thereto), quotas and other trade barriers and restrictions;
transportation delays;
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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,
−Removed: 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: More recently, certain ESG policies, initiatives and activities have become politicized, with ideologically opposing perspectives, such that companies may find themselves unable to satisfactorily consider or address one stakeholder’s concerns without creating concerns among another set of stakeholders with an opposing viewpoint.
+Added: If we are unable to meet our ESG initiatives or evolving investor, industry, or customer expectations and standards, we are perceived to have not responded adequately on any number of ESG matters, or we draw scrutiny from certain people or groups with an opposing viewpoint, we risk damage to our brand and reputation, adverse impacts to our ability to secure government contracts, decreased desirability of our common stock to investors, or limited access to capital markets and other sources of financing..
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.
−Removed: Additionally, changes in legal and regulatory requirements related to ESG have been issued in the E.U., its Member States and other countries, particularly with respect to climate change, emission reduction and environmental stewardship in the U.S., amongst other regulatory efforts, the SEC has proposed rules to enhance and standardize climate-related disclosures in public company filings.
−Removed: We expect legal, regulatory and reporting requirements related to ESG matters to continue to expand globally and increase our costs of compliance.
−Removed: If we are unable to meet our ESG initiatives or evolving investor, industry, or customer expectations and standards, or we are perceived to have not responded adequately on any number of ESG matters, we risk damage to our brand and reputation, adverse impacts to our ability to secure government contracts, decreased desirability of our common stock to investors, or limited access to capital markets and other sources of financing.
+Added: Additionally, changes in legal and regulatory requirements related to ESG have been issued in the State of California and the E.U., its Member States and other countries, particularly with respect to climate change, emission reduction and environmental stewardship, amongst other regulatory efforts.
+Added: As a result, we expect legal, regulatory and reporting requirements related to ESG matters to continue to expand globally and increase our costs of compliance.
Risks Related to Our Intellectual Property and Technology
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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: This may be (1) because patent applications in the United States, Europe and many other non-U.S.
+Added: This may be (1) because patent
+Added: 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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We cannot offer any assurances about which, if any, patents will issue, the breadth of any such patents or whether any issued patents will be found invalid or unenforceable or will be threatened by third parties.
−Removed: In addition, third parties may challenge the validity, enforceability, ownership, inventorship or scope of any of our patents.
+Added: In addition, third parties have challenged in the past and may further challenge in future the validity, enforceability, ownership, inventorship or scope of any of our patents.
Any successful challenge to any of our patents could deprive us of rights necessary for the successful commercialization of our current or future products and could impair or eliminate our ability to collect future revenue and royalties with respect to such products.
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In addition, we may need the cooperation of any such co-owners of such patent rights in order to enforce such patent rights against third parties, and such cooperation may not be provided to us.
−Removed: Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
+Added: foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
Moreover, the research resulting in certain of our patents and technology was funded in part by the U.S.
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Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.
−Removed: If we are prevented from enforcing our intellectual property rights because of governmental regulatory policies or political pressure or action, our sales and profitability may be materially adversely affected.
−Removed: Our ability to maintain and grow our product sales and profitability depends, in part, on our ability to maintain and enforce our patents and other intellectual property rights.
−Removed: 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 Clea nCap® pro duct in connection with the production of COVID-19 vaccines.
−Removed: 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.
−Removed: If we are unable to successfully navigate these considerations, the future revenues and profitability of our business could be negatively impacted.
−Removed: We are unable to estimate the impact of these potential policies given that they remain undefined and their adoption is uncertain.
Our internal computer systems, or those of our customers, collaborators or other contractors, have been and may in the future be subject to cyber-attacks or security breaches, which could result in a material disruption of our product development programs or otherwise adversely affect our business, financial condition, results of operations, cash flows and prospects.
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In addition, outside parties have previously attempted and may in the future attempt to penetrate our systems or those of our vendors or fraudulently induce our personnel or the personnel of our vendors to disclose sensitive information in order to gain access to our data and/or systems or make unauthorized payments to third parties.
−Removed: Like other companies, we have on occasion experienced, and will continue to experience, data security incidents involving access to company data, unauthorized payments and threats to our data and systems, including malicious codes and viruses, phishing, business email compromise attacks, or other cyber-attacks.
+Added: Like other companies, we have on occasion experienced, and will continue to
+Added: experience, data security incidents involving access to company data, unauthorized payments and threats to our data and systems, including malicious codes and viruses, phishing, business email compromise attacks, or other cyber-attacks.
The number and complexity of these threats continue to increase over time.
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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,
−Removed: 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, 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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Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld information material to patentability from the USPTO, or made a misleading statement, during prosecution.
−Removed: Third parties may raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.
+Added: Third parties have raised similar claims in the past, and may raise similar claims in the future, before administrative bodies in the United States or abroad, even outside the context of litigation.
Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).
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Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect.
−Removed: In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents.
+Added: In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these
These third parties could bring claims against us or our collaborators that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages.
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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.
−Removed: Third parties have, and may
−Removed: in the future have, U.S.
+Added: Third parties have, and may in the future have, U.S.
issued patents and pending patent applications that may cover our current or future products.
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These companies may have a competitive advantage over us due to their size, cash resources and greater capabilities with respect to clinical development and commercialization.
−Removed: Furthermore, companies that perceive us as a competitor may be unwilling to assign or license rights to us.
+Added: Furthermore, companies that perceive us as a
+Added: competitor may be unwilling to assign or license rights to us.
If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have on reasonable terms or at all, we may have to abandon development of the relevant program or current or future product and our business, financial condition, results of operations, cash flows and prospects could suffer.
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The America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
−Removed: Specifically, the America Invents Act reforms United States patent law in part by changing the U.S.
+Added: Specifically, the America Invents Act reformed United States patent law in part by changing the U.S.
patent system from a “first to invent” system to a “first inventor to file” system.
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Our existing level of indebtedness may increase and adversely affect our business and growth prospects, growth prospects, and financial condition, as well as our ability to raise additional capital on favorable terms, which could, in turn, limit our ability to develop or acquire new products, services, technologies and methodologies.
−Removed: As of December 31, 2023, we had total current and long-term indebtedness outstanding of approximately $524.1 million, including term loans of $533.1 million, and unamortized debt issuance costs of $9.0 million.
+Added: As of December 31, 2024, we had total current and long-term indebtedness outstanding of approximately $295.9 million, including term loans of $299.7 million less unamortized debt issuance costs of $3.8 million.
We may incur significant additional indebtedness in the future.
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We do not know whether we will be able to take any of these actions on a timely basis, on terms satisfactory to us or at all.
−Removed: Our indebtedness, the cash flow needed to satisfy our debt and the covenants contained in the Credit Agreement have important consequences, including:
+Added: Our indebtedness, the cash flow needed to satisfy our debt and the covenants contained in our credit agreement have important consequences, including:
• limiting funds otherwise available for financing our capital expenditures by requiring us to dedicate a portion of our cash flows from operations to the repayment of debt and the interest on this debt;
• limiting our ability to incur or prepay existing indebtedness, pay dividends or distributions, dispose of assets, engage in mergers and consolidations, make acquisitions or other investments and make changes in the nature of the business, among other things;
−Removed: • making us more vulnerable to rising interest rates, as certain of our borrowings, including borrowings under the Credit Agreement, bear variable rates of interest;
+Added: • making us more vulnerable to rising interest rates, as certain of our borrowings, including borrowings under our credit agreement, bear variable rates of interest;
• making us more vulnerable in the event of a downturn in our business.
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Certain borrowings under our credit agreement bear variable rates of interest.
−Removed: Increase in interest rates directly increase the amount of interest we are required to pay, and negatively impacts our net income and cash flows, including cash available for servicing our indebtedness more generally.
+Added: An increase in interest rates directly increases the amount of interest we are required to pay on our variable rate borrowings, and negatively impacts our net income and cash flows, including cash available for servicing our indebtedness more generally.
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.
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If these alternative measures are not successful, we may be required to sell material assets or operations to attempt to meet our debt service obligations.
−Removed: Further, we may not be able to consummate these asset sales (including as a result of restrictions imposed on us under the Credit Agreement) or sell assets at prices and on terms that we believe are fair, and any proceeds that we do receive may not be adequate to meet any debt service obligations then due.
+Added: Further, we may not be able to consummate these asset sales (including as a result of restrictions imposed on us under our credit agreement) or sell assets at prices and on terms that we believe are fair, and any proceeds that we do receive may not be adequate to meet any debt service obligations then due.
The terms of the financing documents governing our Credit Agreement restrict our current and future operations, particularly our ability to respond to changes or to take certain actions.
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We expect that the aggregate payments that we may be required to make under the Tax Receivable Agreement may be substantial.
−Removed: 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.
−Removed: of LLC Units from MLSH 1 and the corresponding tax attributes to be approximately $7.1 million.
+Added: Assuming no material changes in the relevant tax law, we expect that no 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 are probable.
This determination is based on our estimate of taxable income for the year ended December 31, 2024.
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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.
−Removed: 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
−Removed: considered probable at that time and recorded on the consolidated balance sheet and within earnings.
+Added: There have been no changes to our position as of December 31, 2024.
+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 considered probable at that time and recorded on the
+Added: consolidated balance sheet and within earnings.
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.
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however, we estimate that such payments may be substantial.
−Removed: 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: 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.
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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See “Dividend Policy.”
−Removed: Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our operating results and financial condition.
+Added: Unanticipated changes in our effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our operating results and financial condition.
We are subject to income taxes in the U.S.
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Therefore, we have less than 40% of the value of our total assets (exclusive of U.S.
−Removed: government securities and cash items) in “investment securities.” However, if we were to lose the
−Removed: right to manage and control Topco LLC, interests in Topco LLC could be deemed to be “investment securities” under the 1940 Act.
+Added: 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.
We intend to conduct our operations so that we will not be deemed to be an investment company.
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Risks Related to Being a Public Company
−Removed: 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 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.
+Added: The restatement of our previously issued quarterly financial statements has subjected us to additional costs, risks and uncertainty and may also affect investor confidence and harm our reputation.
+Added: As discussed in Note 18 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K, we determined that our unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2024 and the three and nine months ended September 30, 2024 required restatement primarily to correct an error we identified relating to the timing of revenue recognition for a product sale with non-standard contractual terms.
+Added: Assessment of the error and the effectiveness of the Company’s disclosure controls and procedures and its internal control over financial reporting, the resulting restatement of our unaudited condensed consolidated financial statements for the impacted periods, and the ongoing process of remediating the material weaknesses in our internal control over financial reporting have diverted management’s attention and caused us to incur unanticipated expenses for legal, audit and other professional services fees.
+Added: The restatement and the associated non-reliance on our previously issued quarterly financial statements and other related financial information could also cause investors to lose confidence in our financial reporting and harm our reputation, which in turn, could have a material adverse effect on our business, financial condition, results of operations, cash flows and prospects.
+Added: We are currently subject to a putative securities class action lawsuit, and face the potential for additional, litigation or regulatory inquiries in connection with or related to the restatement and associated material weaknesses, including claims involving the U.S.
+Added: federal securities laws.
+Added: Litigation and any regulatory inquiries are likely to divert management’s time and attention and, regardless of the outcome of such litigation, we will incur legal and other costs of defense, which could be significant.
+Added: Further, if we do not prevail in the litigation, we could be required to pay substantial damages or settlement costs, which could have a material adverse effect on our financial condition, results of operations and cash flows.
+Added: We have identified material weaknesses in our internal control over financial reporting and, if we fail to remediate these material weaknesses in a timely manner or at all, we may not be able to comply with our financial reporting obligations, which could expose us to additional legal and business risks and uncertainties.
+Added: As disclosed in Part II, Item 9A, “Controls and Procedures” in this Annual Report on Form 10-K, we identified the following material weaknesses as of December 31, 2024:
+Added: • we did not design and operate effective controls over the Company’s revenue process;
+Added: • we did not operate effective controls over the Company’s quantitative goodwill impairment assessment.
+Added: The material weaknesses related to our revenue process resulted in the restatement of our unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2024, and as of and for the three and nine months ended September 30, 2024.
+Added: As a result of the material weaknesses, management concluded that our internal control over financial reporting was not effective as of December 31, 2024.
+Added: While we are actively engaged in the process of designing and implementing a plan, including appropriate controls, to remediate the identified material weaknesses, there can be no assurance that our actions will fully remediate the material weaknesses in a timely manner, if at all.
+Added: The implementation of remediation measures will require validation and testing of the design and operating effectiveness of the respective controls over several financial reporting cycles.
+Added: If the actions we take do not sufficiently remediate the material weaknesses in a timely manner, our ability to record, process and report financial information accurately could be adversely affected, and there may continue to be a reasonable possibility that these control deficiencies, or others, could result in an additional material misstatement of our financial statements that would not be prevented or detected on a timely basis.
+Added: If this occurs, it could jeopardize our ability to comply with our financial reporting obligations, including under SEC rules and regulations, NASDAQ listing standards and the financial covenants under our credit agreement, and expose us to additional risks as further discussed below.
+Added: If we are unable to design and maintain proper and effective internal control over financial reporting in the future, or our internal control over financial reporting is determined by us or our auditors to not be operating effectively, we may be exposed to additional risks and 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.
−Removed: Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP.
−Removed: 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, 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.
+Added: Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial
+Added: reporting and the preparation of financial statements in accordance with GAAP.
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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Further, our independent registered public accounting firm must report on the effectiveness of our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act.
−Removed: 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 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.
−Removed: 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.
+Added: As noted above and further disclosed in Part II, Item 9A, “Controls and Procedures” of this Annual Report, we identified material weaknesses in our internal control over financial reporting as of December 31, 2024,and as a result, our management concluded that our disclosure controls and procedures and internal control over financial reporting were not effective as of December 31, 2024.
+Added: While we are actively engaged in the process of designing appropriate controls to address these material weaknesses, there can be no assurance that the actions will fully remediate the material weaknesses in a timely manner or that there will not be additional material weaknesses in our internal control over financial reporting in the future.
+Added: If we are unable to remediate the identified material weaknesses in a timely manner, or at all, or are otherwise unable to maintain effective internal control over financial reporting in the future, our ability to record, process and report financial information accurately, and to comply with our financial reporting obligations, could be adversely impacted.
+Added: If this occurs, it could jeopardize our ability to comply with our financial reporting obligations, including under SEC rules and regulations, NASDAQ listing standards and the financial covenants under our credit agreement, which, in turn, could subject us to regulatory enforcement actions or stockholder litigation, cause us to breach the covenants under our credit agreement, limit our ability to access the credit and capital markets, adversely affect investor confidence in us and the value of our Class A common stock, and harm our reputation, which may make it more difficult for us to market and sell products and services to new and existing customers.
+Added: The pending putative securities class action as well as future potential litigation or regulatory enforcement actions will require management attention and resources and cause us to incur unanticipated costs, which could be significant, and raise other risks to our business operations.
Risks Related to Our Class A Common Stock
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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
−Removed: 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.
−Removed: The Director Nomination Agreement provides that GTCR may assign such right to a GTCR affiliate.
+Added: (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: The Director Nomination Agreement provides that GTCR may assign such right to a GTCR
The Director Nomination Agreement prohibits us from increasing or decreasing the size of our Board without the prior written consent of GTCR.
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• 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
−Removed: 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 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;
16 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
−Removed: 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 stock price may be volatile for reasons unrelated to our operating performance and financial condition.
−Removed: 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.
−Removed: 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: 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.
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.
−Removed: 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.
−Removed: 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: As of December 31, 2024, we had 141,976,348 outstanding shares of Class A common stock, 20,150,005 of which were held by MLSH 2, and further, as of December 31, 2024, an additional 110,684,080 shares of Class A common stock are issuable upon the exchange by MLSH 1 of its interest in Topco.
+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
+Added: restrictions on resale imposed by U.S.
federal securities laws.
12 unchanged sentences
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.