MESA LABORATORIES INC /CO/

Previous wording

In addition to the other information set forth in this Annual Report on Form 10-K and other documents we filed with the SEC, you should carefully consider the following factors, which could materially affect our business, financial condition or results of operations in future periods*.The risks and uncertainties described below are those that we have identified as material,butthese**are not the only risks and uncertainties facing us.**Our business is also subject to general risks and uncertainties that affect many other companies, such as market conditions, economic conditions, geopolitical events, changes in laws, regulations or accounting rules, fluctuations in interest rates, terrorism, wars or conflicts, major health concerns, natural disasters or other disruptions of expected business conditions.*Additional risks and uncertainties not currently known to us or that we currently believe are immaterial also may impair our business, including our results of operations, liquidity and financial condition.

Current wording

In addition to the other information set forth in this annual report other documents we filed with the SEC, you should carefully consider the following factors which could materially affect our business, financial condition or results of operations in future periods*.The risks and uncertainties described below are those that we have identified as material,butthese**are not the only risks and uncertainties facing us.*Our business is also subject to general risks and uncertainties that affect many other companies, such as market conditions, economic conditions, geopolitical events, changes in laws, regulations or accounting rules, fluctuations in interest rates, terrorism, wars or conflicts, major health concerns, natural disasters or other disruptions of expected business conditions. Additional risks and uncertainties not currently known to us or that we currently believe are immaterial also may impair our business, including our results of operations, liquidity and financial condition.

Previous wording

Our business is sensitive to general economic conditions, market disruptions and uncertainties. We have been affected in recent years by elevated interest rates, reduced levels of capital expenditures in industries we serve, inflation in domestic and international markets, and labor availability constraints. In addition to these factors, recent and any further significant developments or changes in international trade, national laws or policies to protect or promote domestic interests and/or address foreign competition (including the imposition of tariffs), slow or disrupted global economic growth, increases in inflation, changes or anticipation of potential changes in governmental trade, fiscal, tax and monetary policies, volatility in the currency and credit markets, high levels of unemployment or underemployment, changes in capital requirements for financial institutions, government deficit reduction and budget negotiation dynamics, sequestration or government shut-downs, austerity measures, sovereign debt defaults, and other challenges that adversely affect the global economy could adversely affect us and our distributors, customers and suppliers, including by:

Current wording

Our business is sensitive to general economic conditions, market disruptions and uncertainties. We have been affected, and may continue to be affected, by elevated interest rates, reduced levels of capital expenditures in the industries we serve, inflation in domestic and international markets, and labor availability constraints. In addition, recent and any further significant developments or changes in international trade, national laws or policies to protect or promote domestic interests or address foreign competition (including the imposition of further tariffs); slow or disrupted global economic growth; increases in inflation; changes or uncertainty regarding governmental trade, fiscal, tax and monetary policies; volatility in the currency, credit and capital markets; high levels of unemployment or underemployment; changes in capital or liquidity requirements for financial institutions; government deficit reduction efforts and budget negotiation dynamics; sequestration or government shutdowns; austerity measures; sovereign debt defaults; and other conditions that negatively affect the global economy could adversely affect us and our distributors, customers and suppliers, including by:

Previous wording

If growth in the global economy or in any of the markets we serve slows for a significant period, if there is significant deterioration in the global economy or such markets or if improvements in the global economy do not benefit the markets we serve, our business and financial results could be adversely affected. We cannot predict the likelihood, duration or severity of any disruption in financial markets or any adverse economic conditions in the U.S. or other countries. See “Our international operations subject us to a wide range of risks” for further information.

Current wording

If growth in the global economy or in any of the markets we serve slows for a significant period, if economic conditions deteriorate significantly, or if economic improvements do not benefit the markets in which we operate, our business, results of operations and financial results could be adversely affected. We cannot predict the likelihood, duration or severity of any market disruption or adverse economic conditions. See “Our international operations subject us to a wide range of risks” for further information.

Previous wording

International business risks have in the past, and may in the future, negatively affect our business and financial statements. A deterioration in diplomatic relations between the United States and any country where we conduct business could adversely affect our future operations and lead to a decline in profitability. In fiscal year 2025, we generated approximately 11% of our sales from operations in China and 41% of our sales from other non-domestic countries, primarily in Europe. Accordingly, political, economic, legal, compliance, social and business conditions in China and Europe generally can adversely influence our business and financial statements. Subsequent to our fiscal year end, escalating global trade tensions have resulted in tariffs on imported materials and on products we export to other countries, which could adversely impact our total revenues and profitability. Further, considerable uncertainty exists regarding the long-term effects of fiscal and monetary policies pursued domestically and internationally. Uncertainty or adverse changes to conditions in China or Europe, or the policies, laws and regulations of international governments can adversely affect the overall economic growth of countries where we make significant sales, or of the particular industries in which we participate, and can adversely affect our business and financial statements.

Current wording

Global trade tensions have resulted in tariffs on materials we import and on products we export, which have increased, and may continue to increase, our costs and delay certain customer orders. These tariffs could reduce demand for our products and services and disrupt our supply chains. These effects could adversely impact our total revenues and profitability. Further, considerable uncertainty exists regarding the long-term effects of fiscal and monetary policies pursued domestically and internationally. Uncertainty or adverse changes to conditions in markets we serve, or in the laws, regulations or policies of foreign governments, can adversely affect economic growth of countries where we make significant sales, or of the particular industries in which we participate, and can adversely affect our business and financial statements.

Previous wording

Our international operations are governed by the U.S. Foreign Corrupt Practices Act and similar anti-corruption laws outside the United States. Global enforcement of anti-corruption laws has increased in recent years. Any alleged or actual violations of these laws may subject us to government investigations and significant criminal or civil sanctions and other liabilities, and could negatively affect our reputation.

Current wording

Our international operations are also subject to the U.S. Foreign Corrupt Practices Act and similar anti-corruption laws in other jurisdictions. Global enforcement of anti-corruption laws has increased in some countries in recent years. Any alleged or actual violations of these laws may subject us to government investigations, significant criminal or civil penalties and other liabilities, and could negatively affect our business, reputation and financial condition.

Previous wording

Our growth depends in part on the growth of the markets which we serve, and visibility into our markets is limited (particularly for markets into which we sell through distribution). Our revenues and profits depend substantially on the volume and timing of orders received, which are difficult to forecast. Any decline or lower than expected growth in our served markets could diminish demand for our products and services, which would adversely affect our financial results. Certain of our businesses’ demand depends on customers’ capital spending budgets as well as government funding policies and interest rates, and matters of public policy and government budget dynamics as well as product and economic cycles can affect the spending decisions of these customers. Demand for our products and services is also sensitive to changes in customer order patterns, which may be affected by announced price changes, marketing or promotional programs, new product introductions, changes in distributor or customer inventory levels, or other factors. Any of these factors could adversely affect our growth and results of operations in any given period.

Current wording

Demand for certain of our products is influenced by customers’ capital spending budgets, the availability of government research funding, interest rates, and broader matters of public policy and government budget dynamics. Demand for our products and services is sensitive to changes in customer order patterns, which may be affected by announced price changes, marketing or promotional programs, new product introductions, changes in distributor or customer inventory levels, product life cycles, economic cycles or other factors. Any of these factors could adversely affect our growth and results of operations in any given period.

Previous wording

We face competition and if we are unable to compete effectively, we may experience decreased demand and market share, resulting in decreased revenues. Even if we compete effectively, we may be required to reduce prices for our products and services, resulting in decreased profit margins.

Current wording

We face competition and if we are unable to compete effectively, we may experience reduced demand for our products and services and a loss of market share, which could result in decreased revenues. Even if we compete effectively, competitive pressures may require us to reduce prices or offer other concessions, which could decrease our profit margins.

Previous wording

The markets for our current and potential products are competitive. Because of the range of products and services we sell and the variety of markets we serve, we encounter a wide variety of competitors, including several that possess both larger sales forces and greater capital resources.

Current wording

The markets for our current and potential products are competitive. Because of the breadth of our product and service offerings and the variety of markets we serve, we compete against a wide range of competitors, including several that possess larger sales forces and greater capital resources.

Previous wording

In order to compete effectively, we must maintain relationships with key customers, continue to grow our business by establishing relationships with new customers, develop new products and services to maintain and expand our brand recognition, and penetrate new markets, including in high growth markets. Our failure to compete effectively or pricing pressures resulting from competition may adversely impact our results of operations.

Current wording

To compete effectively, we must maintain strong relationships with existing key customers, establish relationships with new customers, continue to develop new products and services, enhance and protect our brand, and expand into new and higher-growth markets. Failure to compete effectively or pricing pressures resulting from competition may adversely impact our results of operations.

Previous wording

Various changes within the industries we serve may limit future demand for our products and may include mergers within key industries we serve, making us more dependent on fewer, larger customers for our sales; decreased product demand driven by changes in customers' regulatory environments or standard industry practices; price competition for key products; and new competitor products that may result in customers discontinuing new orders.

Current wording

Shifts in the industries we serve may limit future demand for our products and negatively affect our financial performance. Such changes may include mergers within key industries, which could increase our reliance on fewer, larger customers or suppliers; changes in customers' regulatory environments or prevailing industry practices that could reduce demand for our products; increased price competition for key products; and the introduction of new competing products that may result in reduced or discontinued customer orders.

Previous wording

Our growth depends on the acceptance of our products and services in the marketplace, the penetration achieved by the companies to which we sell, and our ability to introduce new and innovative products that meet the needs of the various markets we serve. We can offer no assurance that we will be able to continue to introduce new and enhanced products, that the products we introduce, or have introduced, will be widely accepted by the marketplace, or that our direct sales team or independent distributors will successfully penetrate our various markets. Our failure to introduce new and enhanced products or gain widespread acceptance of our products and services could adversely affect our financial results. If we fail to accurately predict future customer needs and preferences, fail to produce viable technologies, or fail to protect the intellectual property related to such technologies, we may invest heavily in research and development of products and services that do not lead to significant revenues, which could adversely affect our profitability. Even if we successfully innovate and develop new and enhanced products and services, we may incur substantial costs in doing so, and our profitability may suffer.

Current wording

Our growth depends on the acceptance of our products and services in the marketplace, market penetration achieved by the companies to which we sell, and our ability to introduce and commercialize new and innovative products that meet the needs of the markets we serve. We can offer no assurance that we will be able to continue to introduce new and enhanced products, that the products we introduce, or have introduced, will achieve broad market acceptance, or that our direct sales team or independent distributors will successfully penetrate existing or new markets. Failure to accurately anticipate customer needs and preferences; develop viable, differentiated and competitive technologies; commercialize new products and services in a timely and cost-effective manner; protect related intellectual property and obtain required regulatory approvals, could adversely affect our growth, results of operations, and financial condition.

Previous wording

Our success depends largely upon the continued service of our employees and our ability to attract, retain and motivate personnel, some of whom work in competitive labor markets. Loss of key personnel or our inability to hire and retain personnel could materially adversely affect our manufacturing efforts, harm our ability to meet compliance requirements, and increase backlog.

Current wording

Our success depends largely upon the continued service of our employees and our ability to attract, retain and motivate personnel, some of whom work in competitive labor markets. The market for highly skilled workers and leaders, particularly in the areas of manufacturing, science, technology and management, is extremely competitive, and expectations from qualified talent in many areas of the labor market have recently evolved and escalated. Loss of key personnel or an inability to hire qualified employees could materially adversely affect our business and financial statements, disrupt manufacturing activities, impede our ability to meet compliance requirements, increase backlog, or inhibit strategic growth.

Previous wording

Adverse changes in our relationships with, or the financial condition, performance, purchasing patterns or inventory levels of, distributors and other channel partners could adversely affect our financial statements.

Current wording

Adverse changes in our relationships with, or the financial condition, performance, or purchasing patterns of, distributors and other channel partners could adversely affect our business, results of operations, and financial condition.

Previous wording

We sell a significant number of products to distributors and other channel partners that have valuable relationships with customers and end-users. Some of these distributors and other partners also sell our competitors’ products or compete with us directly. Adverse changes in our relationships with these distributors and other partners, or adverse developments in their financial condition, performance or purchasing patterns, could adversely affect our business and financial statements.

Current wording

We sell a significant number of products to distributors and other channel partners that have valuable relationships with end customers and end users. Some of these distributors and other partners also sell or utilize our competitors’ products or compete with us directly. Adverse changes in our relationships with these distributors and other partners, adverse developments in their financial condition, performance or purchasing patterns, or consolidation among distributors could adversely affect our business and financial statements. We do not directly control the actions of our distributors. Our distributors may fail to comply with export laws or the terms of their distribution agreements, which could expose us to legal, financial or reputational risks and adversely affect our business and financial statements.

Previous wording

Geopolitical and macroeconomic pressures in the markets in which we operate may adversely affect our financial results.

Current wording

Geopolitical pressures in the markets in which we operate may adversely affect our financial results.

Previous wording

Geopolitical issues around the world can impact macroeconomic conditions and could have a material adverse impact on our financial results. For example, the ultimate impact of military conflicts (such as the conflict between Russia and Ukraine or the conflict in Israel and the surrounding areas) and trade tensions (such as between China and the U.S.) on fuel prices, inflation, the global supply chain and other macroeconomic conditions is unknown and could materially adversely affect global economic growth, disrupting discretionary spending habits and generally decreasing demand for our products and services. While our sales to Russia, Ukraine and Israel have historically produced an immaterial amount of revenues and profitability compared to the overall company, our sales to China have been more substantial, and we cannot predict the impact that global conflicts or tensions may have on future financial results.

Current wording

We cannot predict the impact that global conflicts or tensions may have on future financial results.

Previous wording

We rely on information technology systems, some of which are provided or managed by third parties, to process, transmit and store electronic information (including sensitive data such as confidential business information and/or personally identifiable data relating to employees, customers, and other business partners), and to manage or support a variety of critical business processes and activities (such as receiving and fulfilling orders, billing, collecting and making payments, shipping products, providing services and support to customers and fulfilling contractual obligations). Errors, defects, security issues or other vulnerabilities in third-party technology or in the integration of third-party technology with our systems could result in issues that could harm our business. In addition, some products or software we sell to customers may connect to our systems for maintenance or other purposes. These systems, products and services (including those we acquire through business acquisitions) may be damaged, disrupted or shut down due to attacks by computer hackers, computer viruses, ransomware, human error or malfeasance, power outages, hardware failures, telecommunication or utility failures, catastrophes or other unforeseen events, and in any such circumstances our system redundancy and other disaster recovery planning may be ineffective or inadequate. Attacks may also target hardware, software and information installed, stored or transmitted in our products after such products have been purchased and incorporated into third-party products, facilities or infrastructure. Our information technology systems have been subject to computer viruses, malicious codes, unauthorized access and other cyber-attacks, and we expect the sophistication and frequency of such attacks to continue to increase. Unauthorized tampering, adulteration or interference with our products may adversely affect product functionality and result in loss of data, risk to product safety and product recalls or field actions.

Current wording

We rely on information technology systems, some of which are provided, hosted or managed by third parties, to process, transmit and store electronic information, including sensitive data such as confidential business information and personally identifiable data relating to employees, customers, and other business partners. These systems also support a variety of critical business processes and activities, including receiving and fulfilling orders, billing, collecting and making payments, shipping products, providing services and support to customers and fulfilling contractual obligations. Errors, defects, security issues or other vulnerabilities in our systems, third-party systems, or in the interaction of third-party systems with our technology could disrupt our operations or otherwise harm our business.

Previous wording

Any attacks, breaches, incidents, compromises or other disruptions or damage could: interrupt our operations or the operations of our customers and partners; delay production and shipments; result in misappropriation, destruction or unauthorized disclosure of our and our customers’ intellectual property, trade secrets, personal data, or other confidential information; damage customer, business partner, and employee relationships, and our reputation; or result in defective products or services, legal claims and proceedings, liability and penalties under privacy laws and increased costs for security and remediation, each of which could adversely affect our business, reputation and financial statements.

Current wording

Any cyber incident, system failure, other disruption or damage could interrupt our operations or those of our customers and business partners; delay production and shipments; result in the loss, theft, or unauthorized disclosure of intellectual property, trade secrets, personal data, or other confidential information; damage our reputation and relationships with customers, business partners, and employees; or result in defective products or services, legal claims and proceedings, regulatory investigations, fines, penalties, or increased costs related to remediation and security enhancements. Any of these could adversely affect our business, reputation and financial results.

Previous wording

Further, a significant number of our employees work remotely, which exposes us to greater cybersecurity risks. Any inability to maintain reliable information technology systems and appropriate controls with respect to global data privacy and security requirements and prevent data breaches can result in adverse regulatory consequences, business consequences and litigation.

Current wording

Further, a significant number of our employees work remotely, which may increase our exposure to cybersecurity risks. Any failure to maintain reliable information technology systems, exercise appropriate controls, or comply with data privacy and security requirements can result in adverse regulatory consequences, business consequences and litigation.

Previous wording

Supply chain and manufacturing risks could adversely affect our financial results***. In addition, our reliance upon sole or limited sources of supply for certain materials, components and services could cause production interruptions, delays and inefficiencies.***

Current wording

Disruptions in our supply chains, increases in costs, or manufacturing inefficiencies could adversely affect our financial results. In addition, our reliance upon sole or limited sources of supply for certain materials, components and services could cause production interruptions, delays and inefficiencies.

Previous wording

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

Current wording

Our strategic acquisitions and the organic expansion of our commercial operations have increased the scope and complexity of our business. As a result, we face challenges inherent in efficiently managing a more complex organization with an expanded employee base over multiple geographic regions, including the need to implement and maintain appropriate systems, policies, benefit structures, internal controls, and compliance programs. If we are unable to effectively manage and integrate our growing and geographically diverse operations (including from a cultural perspective), our ability to execute our business strategy and maintain operational efficiency could be negatively impacted, which could adversely affect our operating results and financial statements.

Previous wording

The life sciences and healthcare industries and related industries that we serve have undergone, and are in the process of undergoing, significant changes in an effort to reduce costs, which could adversely affect our financial results.

Current wording

The life sciences, pharmaceutical, healthcare and related industries we serve have undergone, and continue to undergo, significant changes in an effort to reduce costs, which could adversely affect our financial results.

Previous wording

Participants in the healthcare industry and related industries have implemented, and are implementing, significant changes in an effort to reduce costs. Many of the end-users to whom our customers supply products rely on government funding of and reimbursement for healthcare products and services and research activities. The U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “PPACA”), healthcare austerity measures in other countries and other potential healthcare reform changes and government austerity measures have reduced and may further reduce the amount of government funding or reimbursement available to customers or end-users of our products and services and/or the volume of medical procedures using our products and services. For example, the Inflation Reduction Act of 2022 contains various drug price negotiation provisions, inflationary rebates and government-established pricing provisions with varying implementation dates and subjects, and penalties could be imposed on manufacturers who fail to adhere to the government's interpretation of the law. The recent change in U.S. Presidential administration may also result in changes that unfavorably impact industries we serve and our business.

Current wording

Participants in the life sciences, healthcare and related industries have implemented, and continue to implement, significant cost-containment initiatives. Some end users of our products rely, directly or indirectly, on healthcare-related government funding, reimbursement, or research support. Legislative, regulatory, and policy developments such as the U.S. Patient Protection and Affordable Care Act as amended by the Health Care and Education Affordability Reconciliation Act, healthcare austerity measures in other countries, and other healthcare reform initiatives have reduced, and may further reduce, the amount of government funding or reimbursement available to our customers or to end users of our products and services and/or the volume of medical procedures that rely on our products and services. For example, the Inflation Reduction Act of 2022 includes provisions related to drug price negotiations, inflationary rebates and government-established pricing, with varying implementation dates and scopes. Penalties could be imposed on manufacturers who fail to adhere to the government's interpretation of these requirements. Further, changes in U.S. federal or state administrations and in healthcare policies and priorities may result in reforms or actions that unfavorably impact industries we serve and our business.

Previous wording

These changes as well as other impacts from market demand, government regulations, third-party coverage and reimbursement policies and societal pressures have started changing the way healthcare is delivered, reimbursed and funded and may cause participants in the healthcare industry and related industries that we serve to purchase fewer of our products and services, reduce the prices they are willing to pay for our products or services, reduce the amount of reimbursement and funding available for our products and services from governmental agencies or third-party payors, affect the acceptance rate of new technologies and products and increase our compliance and other costs. All of the factors described above could adversely affect our business and financial results.

Current wording

These and other factors, including market demand dynamics, government regulations, third-party insurance coverage and reimbursement policies, and societal pressures have changed and may continue to change how healthcare is delivered, reimbursed and funded. As a result, participants in the industries we serve may purchase fewer of our products and services, reduce the amount they are willing to pay for our products or services, experience reduced reimbursement and funding, delay or limit the adoption rate of new technologies, or require us to incur higher compliance or operating costs. Any of the factors described above could adversely affect our business and financial results.

Previous wording

The manufacture of many of our products is a highly exacting and complex process, due in part to strict regulatory requirements. Problems may arise during the manufacturing process for a variety of reasons, including equipment malfunction, contamination, failure to follow specific protocols and procedures, problems with raw materials, natural disasters and environmental factors, and if not discovered before the product is released to market could result in recalls and product liability exposure. Because of the time required to approve and license certain regulated manufacturing facilities and other stringent regulations of the FDA and similar agencies regarding the manufacture of certain of our products, an alternative manufacturer may not be available on a timely basis to replace such production capacity. Any of these manufacturing problems could result in significant costs, liability, lost revenues, and loss of market share, as well as negative publicity and damage to our reputation that could reduce demand for our products.

Current wording

The manufacture of many of our products is a highly exacting and complex process, due in part to strict regulatory requirements. Manufacturing issues may arise for a variety of reasons, including equipment malfunctions, contamination, failure to follow specific protocols and procedures, defects or variability in raw materials, natural disasters, or other environmental or external factors. If such issues are not identified prior to product release, they could result in recalls, field actions, or product liability exposure. In addition, due to the time required to approve and license certain regulated manufacturing facilities and stringent oversight by the FDA and similar regulating authorities, alternative manufacturing capacity may not be available on a timely basis to replace disrupted production. Any manufacturing problems could result in significant costs, regulatory or legal liability, lost revenues, loss of market share, negative publicity, and damage to our reputation, which could reduce demand for our products and adversely affect our financial results.

Previous wording

Changes to dialysis methods and equipment capabilities may decrease demand for our renal care products and negatively impact our financial statements.

Current wording

Changes to dialysis methods and equipment capabilities may decrease demand for our renal care products and negatively impact our business, results of operations, and financial condition.

Previous wording

Our Dialyguard product line accounts for approximately one-third of the revenues and forty percent of the gross profit margin associated with our Calibration Solutions division. The majority of revenues in our Dialyguard business are associated with products used in dialysis clinics, while a smaller portion of our sales relate to in-home care. Technological advancements, such as dialysis machines that feature built-in dialysis calibration functionalities, have and may continue to adversely affect demand for our renal care products.

Current wording

Our Dialyguard product line accounts for approximately 30% of the revenues and one-third of gross profit margin associated with our Calibration Solutions division. The majority of revenues in our Dialyguard business are associated with products used in dialysis clinics, while a smaller portion of our sales relate to in-home care. Ongoing technological advancements, including the development of dialysis machines with integrated dialysis calibration capabilities and shifts toward home-based treatments, have and may continue to adversely affect demand for our renal care products.

Previous wording

If we are unable to maintain reliable information technology systems and appropriate controls with respect to global data privacy and security requirements and prevent data breaches, we may suffer adverse regulatory consequences, business consequences and litigation. As a multinational organization, we are subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal and/or sensitive data in the course of our business. The EU General Data Protection Regulation imposes strict requirements on how we collect and process personal data, including, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance. Data privacy laws in other jurisdictions, such as California and Colorado, also impose data privacy obligations. Government enforcement actions can be costly and can interrupt the regular operation of our business, and data breaches or violations of data privacy laws can result in fines, reputational damage and civil lawsuits, any of which may adversely affect our business, reputation and financial statements. In addition, compliance with various data privacy regulations around the world may require significant expenditures and may require changes in our products or business models that reduce revenues.

Current wording

If we are unable to maintain reliable information technology systems and appropriate controls to comply with global data privacy and security requirements and prevent data breaches, we may suffer adverse regulatory, business and legal consequences. As a multinational organization, we are subject to data privacy and security laws, regulations, and customer-imposed requirements in numerous jurisdictions due to our access to and processing of confidential, personal and other sensitive data in the course of our business. For example, the European Union’s General Data Protection Regulation imposes strict requirements on how we collect, process and protect personal data, including, among other things, obligations to provide prompt notice of data breaches to data subjects and supervisory authorities, and significant fines for non-compliance. Data privacy laws in other jurisdictions, such as California and Colorado, also impose data privacy obligations. Government enforcement actions can be costly, disruptive to our operations, and time consuming, and data breaches or violations of data privacy laws can result in fines, civil litigation, or reputational harm, any of which may adversely affect our business and financial statements. In addition, compliance with evolving and increasingly complex data privacy regulations around the world may require significant expenditures and may require changes in our products or business models, which could reduce revenues or increase costs.

Previous wording

Our facilities, supply chains, distribution systems and information technology systems are subject to the risk of catastrophic loss due to fire, flood, earthquake, hurricane, pandemics and epidemics and other public health crises, war, terrorism and other natural or human-made disasters. If any of these facilities, supply chains or systems were to experience a catastrophic loss, it could disrupt our operations, delay production and shipments, result in defective products or services, damage customer relationships and our reputation and result in legal exposure and large repair or replacement expenses. Our insurance coverage with respect to natural disasters is limited and is subject to deductible and coverage limits and may be unavailable or insufficient to protect us against such losses.

Current wording

Our facilities, supply chains, distribution systems and information technology systems are subject to the risk of catastrophic loss from events such as fires, floods, earthquakes, hurricanes, pandemics or other public health crises, armed conflicts, terrorism, or other natural or human-made disasters. A catastrophic event affecting any of these assets or systems could disrupt our operations, delay production and shipments, result in defective products or services, damage customer relationships and our reputation and expose us to legal liability, as well as significant repair or replacement expenses. In addition, our insurance coverage with respect to natural disasters and other catastrophic events is limited, is subject to deductible and coverage limits, and may be unavailable or insufficient to protect us against such losses. As a result, any such event could materially and adversely affect our business, results of operations, and financial statements.

Previous wording

Climate change, or legal or regulatory measures to address climate change and sustainability, may negatively affect us, and any actions we take or fail to take in response to such matters could damage our reputation.

Current wording

Climate change, as well as legal or regulatory measures and stakeholder expectations related to climate change and sustainability, may negatively affect our business and financial results, and any actions we take or fail to take in response to such matters could damage our reputation.

Previous wording

Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere could present risks to our operations. Physical risk resulting from acute changes (such as hurricanes, tornados, wildfires or flooding) or chronic changes (such as droughts, heat waves or sea level changes) in climate patterns can adversely impact our facilities and operations, including the availability of employees who support operations, and can disrupt our supply chains and distribution systems. Concern over climate change can also result in new or additional legal or regulatory requirements designed to reduce greenhouse gas emissions, mitigate the effects of climate change on the environment (such as taxation of, or caps on the use of, carbon-based energy) and/or increase disclosures and stakeholder requests for changes to our processes or reporting with respect thereto. Any such new or additional legal or regulatory requirements may increase the costs associated with, or disrupt, the sourcing, manufacturing and distribution of our products, which may adversely affect our business and financial statements. Failure to comply with any regulatory requirements (such as the new regulations certain jurisdictions have adopted relating to false or misleading claims about a company’s sustainability practices), could negatively impact our business and reputation. Failure to comply with customer requests for information could result in an inability to sell to certain customers.

Current wording

Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere could present risks to our operations. Physical risks resulting from acute events, such as hurricanes, tornados, wildfires or flooding, or from chronic changes, such as droughts, heat waves or rising sea levels, could adversely impact our facilities and operations, including the availability of employees who support our operations, and could disrupt our supply chains and distribution systems. In addition, concern over climate change can result in new or additional legal, regulatory or reporting requirements designed to reduce greenhouse gas emissions, mitigate environmental impacts, limit or tax the use of carbon-based energy, or increase climate-related disclosures and stakeholder information requests. Compliance with additional legal or regulatory requirements may increase our costs or disrupt the sourcing, manufacture or distribution of our products, which may adversely affect our business and financial statements. Failure to comply with applicable legal or regulatory requirements (such as the regulations in certain jurisdictions relating to false or misleading claims regarding sustainability practices), could result in regulatory action, litigation, reputational harm, or financial penalties. Further, if we fail to meet stakeholder expectations regarding sustainability practices and climate-related disclosures or if we fail to respond adequately to customer requests for such information, investor confidence could be adversely affected, our ability to do business with certain customers could be limited, and our reputation could be harmed.

Previous wording

Our ability to grow revenues, earnings and cash flows at or above our historic rates depends in part upon our ability to identify and successfully acquire and integrate businesses at appropriate prices and realize anticipated synergies. We may not be able to consummate acquisitions at rates similar to the past, which could adversely impact our growth rate and our stock price. Promising acquisitions are difficult to identify and execute for a number of reasons, including high valuations, competition among prospective buyers, the availability of affordable funding in the capital markets, and the need to satisfy applicable closing conditions and obtain applicable antitrust and other regulatory approvals on acceptable terms. Changes in accounting or regulatory requirements, or instability in the credit markets, or global crises that prevent travelling or other activities necessary for acquisitions could also adversely impact our ability to consummate acquisitions.

Current wording

Our ability to grow revenues, earnings and cash flows at or above our historic rates depends in part upon our ability to successfully identify acquisition targets, consummate acquisitions on favorable terms, successfully integrate acquired businesses, and realize anticipated synergies. We may not be able to consummate acquisitions at the pace or scale achieved in the past, which could adversely impact our growth rate and stock price. Promising acquisitions are difficult to identify and execute for a number of reasons, including high valuations, competition among prospective buyers, the availability of affordable funding in the capital markets, and the need to satisfy applicable closing conditions and obtain applicable antitrust and other regulatory approvals on acceptable terms. In addition, changes in regulatory requirements, instability in the credit or capital markets, or global events that restrict travel or other activities necessary to evaluate, negotiate or complete acquisitions could adversely impact our ability to pursue and consummate acquisitions.

Previous wording

The indemnification provisions of acquisition agreements by which we have acquired companies may not fully protect us and as a result we may face unexpected liabilities***, or we may have acquisition agreements with no indemnification protection at all.***

Current wording

The indemnification provisions of acquisition agreements by which we have acquired companies may not fully protect us, which could result in unexpected liabilities.

Previous wording

Certain of the acquisition agreements by which we have acquired companies require the former owners to indemnify us against certain liabilities related to the operation of the company before we acquired it. In most of these agreements, however, the liability of the former owners is limited, and certain former owners may be unable to meet their indemnification responsibilities. We cannot guarantee that these indemnification provisions will protect us fully or at all, and as a result we may face unexpected liabilities that could adversely impact our financial statements. In addition, we may enter into acquisition agreements that have no indemnification protection at all.

Current wording

Certain acquisition agreements by which we have acquired companies require the former owners to indemnify us against certain liabilities related to the operation of the acquired business before the acquisition. In most cases, however, the liability of the former owners is limited, and certain former owners may be unable to meet their indemnification obligations. We cannot guarantee that indemnification provisions will protect us fully or at all, and as a result we may face unexpected liabilities and may be required to bear the costs associated with such liabilities, which could adversely impact our business, results of operations, and financial condition.

Previous wording

We actively evaluate various strategic transactions on an ongoing basis, and in order to complete such transactions, we may need to seek additional financing. We may not be able to secure such financing on favorable terms, or at all. In addition, future acquisitions may require the issuance of additional equity securities, which may result in dilution to our stockholders, or the issuance of debt securities, which may subject us to financial risks and limits on our operations.

Current wording

We actively evaluate potential strategic acquisitions, and completing such transactions may require us to obtain additional financing. We may not be able to secure such financing on favorable terms, or at all. In addition, future acquisitions may require the issuance of equity securities, which may result in dilution to our stockholders, or the issuance of debt securities, which may increase our financial risks and impose limits on our operations.

Previous wording

We are subject to extensive regulation.

Current wording

We are subject to extensive and evolving regulatory requirements that affect the approval, manufacture, marketing and commercialization of our products.

Previous wording

The process of obtaining and maintaining required regulatory approvals is lengthy, expensive and uncertain. We can offer no assurance that delays will not occur in the future that could have a significant adverse effect on our ability to introduce new products on a timely basis. Regulatory agencies periodically inspect our manufacturing facilities to ascertain compliance with “good manufacturing practices” and can subject approved products to additional testing and surveillance programs.

Current wording

The process of obtaining and maintaining required regulatory approvals for our products and operations is lengthy, expensive and uncertain. We can offer no assurance that regulatory delays will not occur, which could adversely affect our ability to introduce new products on a timely basis. Regulatory agencies also periodically inspect our manufacturing facilities to assess compliance with “good manufacturing practices” and can subject products that have been approved to additional testing and surveillance programs.

Previous wording

Certain of our products are medical devices and other products subject to regulation by the U.S. FDA, by other federal and state governmental agencies, or by comparable agencies of other countries and regions. We cannot guarantee that we will be able to obtain regulatory clearance (such as 510(k) clearance) or approvals for new products or modifications to (or additional indications or uses of) existing products within our anticipated timeframe or at all, and if we do obtain such clearance or approval, it may be time-consuming, costly and subject to restrictions. Our ability to obtain such regulatory clearances or approvals will depend on many factors and the process for obtaining such clearances or approvals could change over time and may require the withdrawal of products from the market until such clearances are obtained. The global regulatory environment has become increasingly stringent and unpredictable. Several countries that did not have regulatory requirements for medical devices have established such requirements in recent years, and other countries have expanded, or plan to expand, their existing regulations.

Current wording

Certain of our products are medical devices and other regulated products subject to oversight by the FDA, other U.S. federal and state authorities, and comparable agencies in foreign jurisdictions. We cannot guarantee that we will be able to obtain regulatory clearances, such as FDA 510(k) clearances, for new products or for modifications to, or additional indications or uses of, existing products within anticipated timeframes or at all. Even when such approvals are obtained, they may be time-consuming, costly and subject to restrictions. Regulatory requirements and approval processes may also change and could require the withdrawal of products from the market until new or amended clearances are obtained.

Previous wording

Ensuring that our internal operations and business arrangements with third parties comply with applicable laws and regulations involves substantial costs. It is also possible that government authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law. Noncompliance with applicable laws and regulations can result in, among other things, fines, expenses, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of production, failure to receive 510(k) clearance of devices, withdrawal of marketing approvals, reputational damage, business disruption, loss of customers, disbarment from selling to certain federal agencies, criminal prosecutions and other adverse effects. Further, defending against any such actions can be costly and time-consuming and may require significant personnel resources. Therefore, even if we are successful in defending against any such actions brought against us, our business may be negatively impacted.

Current wording

Compliance with applicable laws, regulations and standards involves substantial costs. We and our representatives may at times be subject to reviews, inspections or investigations. If government authorities conclude that our business practices or products do not comply with current or future statutes, regulations, agency guidance or case law, we could be subject to, among other things, fines, expenses, injunctions, civil penalties, product recalls or seizures, total or partial suspension of production, failure to receive 510(k) device clearances, withdrawal of marketing approvals, reputational damage, business disruption, loss of customers, disbarment from selling to certain government agencies, criminal prosecutions and other adverse effects. Defending against any such actions can be costly and time-consuming and may require significant personnel resources. Even if we are successful in defending against any such actions brought against us, our business may be negatively affected.

Previous wording

Once a medical device is permitted to be legally marketed in the United States pursuant to a 510(k) clearance, a manufacturer may be required to notify the FDA of certain modifications to the device. Manufacturers determine in the first instance whether a change to a product requires a new 510(k) clearance or premarket submission, but the FDA may review any manufacturer’s decision. The FDA may not agree with our decisions regarding whether new clearances are necessary. We have made modifications to our products in the past and have determined based on our review of the applicable FDA regulations and guidance that in certain instances new 510(k) clearances or other premarket submissions were not required. We may make similar modifications or add additional features in the future that we believe do not require a new 510(k) clearance. If the FDA disagrees with our determinations and requires us to submit new 510(k) notifications, we may be required to cease marketing or to recall the modified product until we obtain clearance, and we may be subject to significant regulatory fines or penalties.

Current wording

Regulatory requirements govern not only the claims that may be made about approved products, but also whether changes to those products require additional regulatory review or clearance. Manufacturers may be required to notify the FDA of certain modifications to 510(k) cleared devices. Manufacturers must determine whether product modifications require new clearances, and the FDA may review and disagree with the manufacturer’s determinations. We have made product modifications in the past and may do so in the future. If regulators disagree with our determinations regarding whether product modifications or new features require additional clearances, we may be required to cease marketing or to recall modified products until we obtain clearance, and we may be subject to significant regulatory fines or penalties.