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Business and Strategic Risks
−Removed: Conditions in the global economy, the markets we serve, and the financial markets may adversely affect our business, financial statements, and access to capital markets.
+Added: Conditions in the global economy, the markets we serve, and financial markets may adversely affect our business, financial statements, and access to capital markets.
Our business is sensitive to general economic conditions.
−Removed: Slow or disrupted global economic growth, volatility in the currency and credit markets, high levels of unemployment or underemployment, changes or anticipation of potential changes in government fiscal, tax, trade and monetary policies, changes in capital requirements for financial institutions, government deficit reduction and budget negotiation dynamics, sequestration, 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 having the effect of:
+Added: Slow or disrupted global economic growth, heightened inflation, volatility in the currency and credit markets, high levels of unemployment or underemployment, labor availability constraints, reduced levels of capital expenditures, changes or anticipation of potential changes in government fiscal, tax, trade and monetary policies, changes in capital requirements for financial institutions, government deficit reduction and budget negotiation dynamics, sequestration, 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 having the effect of:
reducing demand for our products and services, limiting the financing available to our customers and suppliers, increasing order cancellations and resulting in longer sales cycles and slower adoption of new technologies;
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adversely impacting market sizes and growth rates.
−Removed: 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.
+Added: Inflationary conditions in recent periods have resulted in the U.S.
+Added: Federal Reserve and other financial regulatory bodies implementing increases in interest rates, and these increases have slowed global growth and made a recession more likely. 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.
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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 statements.
−Removed: Certain of our businesses operate in industries that may experience periodic, cyclical downturns.
−Removed: In addition, in certain of our businesses’
+Added: Certain of our businesses’
demand depends on customers’
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Any of these factors could adversely affect our growth and results of operations in any given period.
−Removed: We face competition and if we are unable to compete effectively, we may experience decreased demand and decreased market share resulting in decreased revenues.
−Removed: Even if we compete effectively, we may be required to reduce prices for our products and services resulting in decreased profit margin.
+Added: We face competition and if we are unable to compete effectively, we may experience decreased demand and market share resulting in decreased revenues.
+Added: Even if we compete effectively, we may be required to reduce prices for our products and services resulting in decreased profit margins.
The markets for our current and potential products are competitive.
−Removed: Because of the range of products and services we sell and the variety of markets we serve, we encounter a wide variety of competitors (refer to Item 1.
−Removed: Business for additional details), including several that possess both larger sales forces and greater capital resources.
−Removed: In order to compete effectively, we must maintain longstanding relationships with major 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 leadership position in various product and service categories, and penetrate new markets, including in developing countries and high growth markets.
−Removed: In addition, significant shifts in industry market share can occur in connection with product problems, safety alerts and publications about products, reflecting the competitive significance of product quality, product efficacy and quality systems in our industries.
+Added: 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.
+Added: In order to compete effectively, we must maintain relationships with major 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 developing countries and high growth markets.
Our failure to compete effectively or pricing pressures resulting from competition may adversely impact our results of operations.
Changing industry trends may affect our results of operations.
−Removed: Various changes within the industries we serve may limit future demand for our products and may include the following:
−Removed: changes in dialysis reimbursements that our customers may receive;
−Removed: mergers within other industries we serve, making us more dependent upon fewer, larger customers for our sales;
−Removed: decreased product demand, driven by changes in our customers’
−Removed: regulatory environments or standard industry practices;
+Added: 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;
+Added: decreased product demand driven by changes in customers' regulatory environments or standard industry practices;
price competition for key products;
−Removed: mergers within key industries we serve, concentrating our medical meter and solutions sales with a few, large customers;
−Removed: new competitor products that may result in customers discontinuing new orders or consumables orders.
+Added: and new competitor products that may result in customers discontinuing new orders. 
Our growth depends in part on the timely development, commercialization, and customer acceptance of new and enhanced products and services based on technological innovation.
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Our failure to introduce new and enhanced products or gain widespread acceptance of our products and services could adversely affect our financial results.
−Removed: If we fail to accurately predict future customer needs and preferences, fail to produce viable technologies, or to protect the intellectual property of 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.
−Removed: 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.
−Removed: Competitors may also develop after-market services and parts for our products which attract customers and adversely affect our return on investment for new products. In addition, we face risks in connection with the retirement of old products and customer migration to new products.
−Removed: If we are unable to continue to hire and retain personnel, then we will have trouble manufacturing and marketing our products.
−Removed: Our success depends largely upon the continued service of our management and manufacturing employees and our ability to attract and retain manufacturing and management personnel, some of whom we are recruiting for in-person positions in competitive labor markets, particularly Bozeman, Montana.
−Removed: At times, we face significant competition in the hiring and retention of personnel in competitive markets where other employers may offer superior pay or benefits.
−Removed: Loss of key personnel or our inability to hire and retain personnel could materially adversely affect our manufacturing efforts and increase backlog.
+Added: If we fail to accurately predict future customer needs and preferences, fail to produce viable technologies, or fail to protect the intellectual property of 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.
+Added: 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. 
+Added: If we are unable to continue to hire and retain skilled personnel, we will have difficulty manufacturing and marketing our products.
+Added: Our success depends largely upon the continued service of our management and manufacturing employees and our ability to attract, retain and motivate manufacturing and management personnel, some of whom we are recruiting for in-person positions in competitive labor markets, particularly Bozeman, Montana.
+Added: 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.
Further, if we have to pay manufacturing employees higher wages to attract and retain them, our gross margins and overall profitability may decline. 
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Risks related to these increased foreign operations include:
−Removed: fluctuations in foreign currency exchange rates, which may affect the costs incurred in international operations and could harm our results of operations and financial condition;
+Added: fluctuations in foreign currency exchange rates, which may affect reported results from operations as well as actual costs;
interruption in the transportation of materials to us and finished goods to our customers;
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trade protection measures, embargoes and import or export restrictions and requirements;
−Removed: unexpected changes in laws or regulatory requirements, including changes in tax laws;
+Added: unexpected changes in laws or regulatory requirements, including changes in labor or tax laws;
capital controls and limitations on ownership and on repatriation of earnings and cash;
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Our international operations are governed by the U.S.
−Removed: Foreign Corrupt Practices Act and similar anti-corruption laws outside the U.S.
+Added: Foreign Corrupt Practices Act and similar anti-corruption laws outside the United States.
Global enforcement of anti-corruption laws has increased in recent years, with more enforcement proceedings by U.S.
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Any alleged or actual violations of these laws may subject us to government investigations and significant criminal or civil sanctions and other liabilities, and negatively affect our reputation.
−Removed: Uncertainties remain regarding the consequences of the UK ceasing to be a member state of the EU on January 31, 2020 (commonly referred to as “Brexit”), including the application of the terms of the trade and cooperation agreement with the EU, the impact of new or different laws and regulations as the UK determines which EU laws to replace or replicate, and trade and tax impacts as the UK negotiates its own tax and trade treaties with countries around the world.
−Removed: The impacts from Brexit could add time and expense to the conduct of our business, delay regulatory approval of products, adversely impact the manufacturing or movement of products, adversely impact customer demand, and otherwise adversely affect our business and financial statements both inside and outside the UK. 
−Removed: The COVID-19 pandemic has adversely impacted and continues to pose risks to our business.
−Removed: Since December 2019, an outbreak of a novel strain of a virus named SARS-CoV-2, which causes COVID-19, spread to countries in which we or our customers and suppliers operate, including the United States and caused major disruption throughout the year.
−Removed: The COVID-19 pandemic continues to evolve, and to date, has led to the implementation of various responses, including government-imposed quarantines, extended business closures, travel restrictions and other public health safety measures, as well as reported adverse impacts on healthcare resources, facilities and providers across the United States and in other countries.
−Removed: In response to COVID-19 and in accordance with direction from state and local government authorities, we restricted and may continue to restrict access to our facilities to our office-based employees and monitored and responded to certain external factors in instituting limited travel restrictions during fiscal year 2022.
−Removed: In addition, many of our customers and potential customers closed facilities or limited facility hours due to the spread of COVID-19.
−Removed: Such closures have resulted in, and may continue to result in, our inability to demonstrate and install some of our products, as well as lower demand for certain products. Any interruptions in the installation of ordered products could delay our ability to recognize revenues in a particular period.
−Removed: In addition, we must maintain sufficient production capacity in order to meet anticipated customer demand, which carries fixed costs that we may not be able to offset if installations cannot occur, which would adversely affect our operating margins.
+Added: The COVID-19 pandemic, or similar public health crises, could have an adverse impact and risk to our business.
+Added: Since December 2019, COVID-19 has spread to countries in which we or our customers and suppliers operate and has caused major disruption.
+Added: The COVID-19 virus has led to the implementation of various responses, including government-imposed quarantines, extended business closures, travel restrictions and other public health safety measures, as well as reported adverse impacts on healthcare resources, facilities and providers across the United States and in other countries.
+Added: Our business operations were impacted by such restrictions.
+Added: Many of our customers and potential customers closed facilities or limited facility hours due to the spread of COVID-19.
+Added: Such closures have resulted in, and may continue to result in, our inability to demonstrate and install some of our products, and lower demand for certain products. Any interruptions in the installation of ordered products could delay our ability to recognize revenues in a particular period. 
We operate on a global basis with offices or operations in North America, Europe, and Asia, and global health crises, such as COVID-19, could result in a widespread economic downturn in the industries in which we and our customers operate.
−Removed: The extent to which outbreaks impacts our business and the businesses of our customers will depend on future developments, which remain highly uncertain and cannot be predicted with confidence, such as the continued geographic spread of the disease, the duration of outbreaks, and actions taken in the United States and elsewhere to contain outbreaks and treat the disease, such as vaccination rates and efficacy, social distancing and quarantines, business closures and business disruptions.
−Removed: Recent COVID-19 outbreaks and resulting lockdowns in China have adversely impacted revenues from our Clinical Genomics division during fiscal year 2022, and we expect continued adverse impacts on revenues from our Clinical Genomics division and, to a lesser extent, the rest of the company in fiscal year 2023. Some factors from the COVID-19 pandemic that could delay or otherwise adversely affect our operations and performance include:
−Removed: disruptions in our supply chains;
−Removed: limitations on travel that could interrupt our ability to provide installation or maintenance services at customer sites and could impact our ability to effectively market our products;
−Removed: interruption in global shipping affecting the transport of our products and other supplies;
−Removed: restrictions on business operations by local, state, or federal governments;
−Removed: business disruptions or cybersecurity risks associates with a substantial portion of our workforce working from home for extended periods of time;
−Removed: the impact of the valuation of our financial assets due to market volatility;
−Removed: interruption or delays in the operations of the FDA and comparable foreign regulatory agencies, which may impact review, inspection, clearance, and approval timelines;
−Removed: delays in partner clinical trials due to government-imposed restrictions or lockdowns in China.
+Added: The extent to which outbreaks impact our business and the businesses of our customers will depend on future developments, which remain uncertain and cannot be predicted with confidence, such as the impact of new business closures and business disruptions.
+Added: Government mandated shut-downs and restrictions in China adversely impacted revenues from our Clinical Genomics division during fiscal year 2023. Some effects of the COVID-19 pandemic that could delay or otherwise adversely affect our operations and performance include disruptions in our supply chains, limitations on travel that could interrupt our ability to market products and provide installations or maintenance services at customer sites, interruption in global shipping affecting the transport of our products and supplies, restrictions on business operations by governments, impacts to the valuation of our financial assets due to market volatility, and delays in partner clinical trials due to government-imposed restrictions or lockdowns in China, among others.
The COVID-19 pandemic could also have the effect of heightening other risk factors described in this report.
+Added: Although the COVID-19 pandemic has largely subsided as a public health matter, we may experience material adverse impacts to our business as a result of the pandemic's adverse impact on the global economy, in-person collaboration and sales efforts, and our customers' changed purchasing behaviors and confidence.
Operational Risks
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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.
−Removed: Security breaches of systems provided or enabled by us, regardless of whether the breach is attributable to a vulnerability in our products or services, could result in the misappropriation, destruction or unauthorized disclosure of confidential information or personal data belonging to us or to our employees, partners, customers, patients or suppliers.
+Added: Security breaches of systems provided or enabled by us, regardless of whether the breach is attributable to a vulnerability in our products or services, could result in the misappropriation, destruction or unauthorized disclosure of confidential information or personal data belonging to us or to our employees, partners, customers, or suppliers.
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.
−Removed: Unauthorized tampering, adulteration or interference with our products may also adversely affect product functionality and result in loss of data, risk to patient safety and product recalls or field actions.
+Added: Unauthorized tampering, adulteration or interference with our products may also adversely affect product functionality and result in loss of data, risk to product safety and product recalls or field actions.
Any attacks, breaches or other disruptions or damage could interrupt our operations or the operations of our customers and partners, delay production and shipments, result in theft of our and our customers’
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We purchase materials, components and equipment from third parties for use in our manufacturing operations.
−Removed: Our results of operations could be adversely impacted if we are unable to adjust our purchases to reflect changes in customer demand and market fluctuations, including those caused by seasonality or cyclicality.
+Added: Our results of operations could be adversely impacted if we are unable to adjust our purchases to reflect changes in customer demand and market fluctuations.
Suppliers may extend lead times, limit supplies or increase prices.
−Removed: If we cannot purchase sufficient products at competitive prices and quality and on a timely enough basis to meet increasing demand, we may not be able to satisfy market demand, product shipments may be delayed, our costs may increase, or we may breach our contractual commitments and incur liabilities.
+Added: If we cannot purchase sufficient products at competitive prices and of sufficient quality on a timely enough basis to meet increasing demand, we may not be able to satisfy market demand, product shipments may be delayed, our costs may increase, or we may breach our contractual commitments and incur liabilities.
In addition, some of our businesses purchase certain required products from sole or limited source suppliers for reasons of quality assurance, regulatory requirements, cost effectiveness, availability or uniqueness of design.
If these or other suppliers encounter financial, operating or other difficulties or if our relationship with them changes, we might not be able to quickly establish or qualify replacement sources of supply.
−Removed: The supply chains for our businesses were impacted in fiscal year 2022 and could also be disrupted in the future by supplier capacity constraints, supplier bankruptcy or exiting of the business for other reasons, decreased availability of key raw materials or commodities and external events such as natural disasters, pandemics or other public health problems, war, terrorist actions, governmental actions and legislative or regulatory changes.
+Added: The supply chains for our businesses were impacted in fiscal year 2023 and could also be disrupted in the future by supplier capacity constraints, supplier bankruptcy or exiting of the business for other reasons, decreased availability of key raw materials or commodities and external events such as natural disasters, pandemics or other public health problems, war, terrorist actions, governmental actions and legislative or regulatory changes.
Any of these factors could result in production interruptions, delays, extended lead times and inefficiencies.
+Added: Our revenues and other operating results depend in large part on our ability to manufacture and assemble our products in sufficient quantities and in a timely manner.
+Added: Any interruptions we experience in the manufacture or shipment of our products or changes to the way we manufacture products could delay our ability to recognize revenues in a particular period.
+Added: In addition, we must maintain sufficient production capacity in order to meet anticipated customer demand, which carries fixed costs that we may not be able to offset if orders slow, which would adversely affect our operating margins.
+Added: If we are unable to manufacture our products consistently, in sufficient quantities, and on a timely basis, our revenues, gross margins and our other operating results will be materially and adversely affected.
Because we cannot always immediately adapt our production capacity and related cost structures to changing market conditions, our manufacturing capacity may at times exceed or fall short of our production requirements.
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Our financial results are subject to fluctuations in the cost and availability of components and commodities that we use in our operations.
−Removed: As discussed in Item 1.
−Removed: Business —Manufacturing and Materials, our manufacturing and other operations employ a wide variety of components, and raw materials and other commodities, including metallic-based components, electronic components, chemicals, and plastics and other petroleum-based products.
+Added: Our manufacturing operations employ a wide variety of components and raw materials and other commodities, including metallic-based components, electronic components, chemicals, and plastics and other petroleum-based products.
Prices for and availability of these components, and raw materials and other commodities have fluctuated significantly in the past, and more recently have increased.
−Removed: Any sustained interruption in the supply of these items could adversely affect our business.
+Added: Any sustained interruption in the supply of these items could disrupt production, delay customer order fulfillments, and adversely affect our business.
In addition, due to the highly competitive nature of the industries that we serve, the cost-containment efforts of our customers and the terms of certain contracts we are party to, if components and commodity prices rise, we may be unable to pass along cost increases through higher prices.
If we are unable to fully recover higher costs through price increases or offset these increases through cost reductions, or if there is a time delay between the increase in costs and our ability to recover or offset these costs, our margins and profitability could decline, and our financial statements could be adversely affected.
−Removed: We are dependent on our  
−Removed: suppliers to deliver components, and a shortage of and increasing prices of components have and could continue to disrupt our production and delay order fulfillment.
−Removed: Products we sell are made of components, including electronic components, glass, plastics, and packaging that we source globally from suppliers who, in turn, source components from their suppliers.
−Removed: If there is a shortage of a key component in our supply chain, and the component cannot be easily sourced from a different supplier, the shortage may disrupt our production which may, in turn, delay order fulfillment. We are currently experiencing long lead times, and in some cases, difficulty obtaining components from our existing suppliers, which has resulted in delayed order fulfillment to varying degrees in our divisions, especially the Calibration Solutions and Biopharmaceutical Development divisions, and to a lesser extent the Sterilization and Disinfection Control and Clinical Genomics divisions. 
−Removed: In addition, costs for components and transportation costs have increased, which may reduce our gross profit margins unless and until we are able to pass the cost increases along to our customers. There are several reasons for the supply chain disruptions to components that we rely on to manufacture our products, including:
−Removed: increased demand for other products that use the same components as those we purchase, manufacturing shut-downs during the past 18 months that reduced production of components, obsolescence of materials we have historically purchased, labor issues, and long lead times for raw materials used in the production of components. A continued shortage of components or other key materials that comprise the components could cause a significant disruption to our production schedule and have a substantial adverse effect on our financial condition or results of operations. 
+Added: In addition, transportation costs have increased, which may reduce our gross profit margins unless and until we are able to pass the cost increases along to our customers. There are several reasons for the supply chain disruptions to components that we rely on to manufacture our products, including:
+Added: increased demand for other products that use the same components as those we purchase, manufacturing shut-downs that reduced production of components, obsolescence of materials we have historically purchased, labor issues, and long lead times for raw materials used in the production of components. A continued shortage of components or other key materials that comprise the components could cause a significant disruption to our production schedule and have a substantial adverse effect on our financial condition or results of operations. 
Significant developments or uncertainties stemming from the U.S.
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For example, the ultimate impact of the conflict in Ukraine 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.
−Removed: While we do not purchase any of significant raw materials directly from Russia, it is a significant global producer of fuel, nickel, and copper.
−Removed: Disruptions in the markets for those inputs could negatively impact the macroeconomy.
+Added: While we do not purchase any significant raw materials directly from Russia, it is a significant global producer of fuel, nickel, and copper.
+Added: Disruptions in the markets for those inputs could negatively impact the global economy.
We cannot predict the extent or duration of sanctions in response to the conflict in Ukraine, nor can we predict the effects of legislative or other governmental actions or regulatory scrutiny of Russia and Belarus, Russia's other allies or other countries with which Russia has significant trade or financial ties, including China.
−Removed: The conflict in Ukraine may also exacerbate geopolitical tensions globally.
While our sales to Russia have historically produced an immaterial amount of revenues and profitability compared to the overall company, we cannot predict the impact that the conflict may have on future financial results.
−Removed: For example, Russian customers for some of our product lines may choose a competitors' product and we may not be able to regain the business, including future sales to those Russian customers.
Violation of data privacy laws could adversely affect our business, reputation and financial statements.
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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.
−Removed: The EU General Data Protection Regulation impose strict requirements in 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.
+Added: 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 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.
−Removed: In addition, compliance with the varying data privacy regulations around the world may require significant expenditures and may require changes in our products or business models that increase competition or reduce revenues.
−Removed: Changes to dialysis methods may decrease demand for our dialysis products and negatively impact our financial statements.
−Removed: In July 2019, an executive order was signed by the President of the United States that is intended to change the way that kidney care is delivered to patients and reimbursed through government-sponsored medical programs.
−Removed: The executive order’s objectives included encouraging dialysis patients to receive treatments through in-home care rather than at a dialysis clinic and also reducing the number of people developing kidney failure.
−Removed: The extent of the impact of the executive order, as well as the timing of the impact on procedures and the market in general is currently unknown. 
−Removed: Currently, our Dialyguard product line accounts for approximately one-third of the revenues and gross margin associated with our Calibration Solutions division.
−Removed: The majority of the revenues in our Dialyguard business are associated with products that are used in dialysis clinics, while a smaller portion of our sales relate to in home care.
−Removed: Another recent development is dialysis machines that feature built-in dialysis calibration functionalities.
−Removed: Demand for our dialysis products may be adversely affected by these or other developments in the dialysis industry.
+Added: In addition, compliance with the varying data privacy regulations around the world may require significant expenditures and may require changes in our products or business models that reduce revenues.
+Added: Changes to dialysis methods and equipment capabilities may decrease demand for our dialysis products and negatively impact our financial statements.
+Added: Our Dialyguard product line accounts for approximately one-third of the revenues and gross margin associated with our Calibration Solutions division.
+Added: 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.
+Added: Technological advancements, such as dialysis machines that feature built-in dialysis calibration functionalities, have and may continue to adversely affect demand for our dialysis products.
We may be unable to efficiently manage our growth as a larger and more geographically diverse organization.
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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.
−Removed: 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, as a result, the market price of our common stock.
+Added: 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.
If we suffer loss to our facilities, supply chains, distribution systems or information technology systems due to a catastrophic event, our operations could be seriously harmed.
−Removed: Our facilities, supply chains, distribution systems and information technology systems are subject to catastrophic loss due to fire, flood, earthquake, hurricane, pandemics and epidemics and other public health crises, war, terrorism or other natural or man-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.
+Added: Our facilities, supply chains, distribution systems and information technology systems are subject to catastrophic loss due to fire, flood, earthquake, hurricane, pandemics and epidemics and other public health crises, war, terrorism or 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.
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Participants in the health care 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 health care products and services and research activities.
−Removed: Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “PPACA”), health care austerity measures in other countries and other potential health care 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.
−Removed: Global economic uncertainty or deterioration can also adversely impact government funding and reimbursement.
−Removed: 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 health care 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 amounts 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.
+Added: Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “PPACA”), health care austerity measures in other countries and other potential health care 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. 
+Added: 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 health care 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.
−Removed: Defects or quality issues associated with our products could adversely affect the results of our operations.
−Removed: Manufacturing or design defects or “bugs”
−Removed: in, unanticipated use of, safety or quality issues (or the perception of such issues) with respect to, standard use of, “off label”
−Removed: use of, or inadequate disclosure of risks relating to the use of products and services that we make or sell (including items that we source from third parties or that we provide to third parties who sell on our behalf) can lead to property damage, loss of profits or other liability.
−Removed: These events could lead to recalls or safety alerts, result in the removal of a product or service from the market and result in product liability or similar claims being brought against us.
−Removed: Recalls, removals and product liability and similar claims (regardless of their validity or ultimate outcome) can result in significant costs, as well as negative publicity and damage to our reputation that could reduce demand for our products and services. Any of the above can result in the discontinuation of marketing of such products in one or more countries and give rise to claims for damages from persons who believe they have been injured as a result of product issues, including claims by individuals or groups seeking to represent a class.
The manufacture of many of our products is a highly exacting and complex process, and if we directly or indirectly encounter problems manufacturing products, our reputation, business and financial results could suffer.
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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.
−Removed: Any of these manufacturing problems could result in significant costs, liability and lost revenues, loss of market share as well as negative publicity and damage to our reputation that could reduce demand for our products.
−Removed: Our failure to maintain appropriate environmental, social, and governance ("ESG") practices and disclosures could result in reputational harm, a loss of customer and investor confidence, and adverse business and financial results.
−Removed: Governments, investors, customers, and employees are enhancing their focus on ESG practices and disclosures, and expectations in this area are rapidly evolving and increasing.
−Removed: While we monitor the various and evolving standards and associated reporting requirements, failure to adequately maintain appropriate ESG practices that meet diverse stakeholder expectations may result in the loss of business, reduced market valuation, an inability to attract customers, and an inability to attract and retain top talent.
−Removed: Climate change, or legal or regulatory measures to address climate change, may negatively affect us.
+Added: 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.
+Added: 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.
Climate change resulting from increased concentrations of carbon dioxide and other greenhouse gases in the atmosphere could present risks to our operations.
−Removed: Physical risk resulting from acute changes (such as hurricane, tornado, wildfire or flooding) or chronic changes (such as droughts, heat waves or sea level changes) in climate patterns can adversely impact our facilities and operations and disrupt our supply chains and distribution systems.
+Added: 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 and 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 and/or mitigate the effects of climate change on the environment (such as taxation of, or caps on the use of, carbon-based energy).
Any such new or additional legal or regulatory requirements may increase the costs associated with, or disrupt, sourcing, manufacturing and distribution of our products, which may adversely affect our business and financial statements.
−Removed: If we are unable to manufacture our products in sufficient quantities and in a timely manner, our operating results will be harmed, our ability to generate revenue could be diminished, and our gross margin may be negatively impacted.
−Removed: Our revenues and other operating results will depend in large part on our ability to manufacture and assemble our products in sufficient quantities and in a timely manner.
−Removed: Any interruptions we experience in the manufacturing or shipping of our products - such as the delay that occurred when we moved our Butler, New Jersey facilities to Lakewood, Colorado resulting in changes to the way we manufacture certain products - could delay our ability to recognize revenues in a particular quarter.
−Removed: Manufacturing problems can and do arise, and as demand for our products increases, any such problems could have an increasingly significant impact on our operating results.
−Removed: We may not be able to quickly ship products and recognize anticipated revenues if we experience significant delays in the manufacturing process.
−Removed: In addition, we must maintain sufficient production capacity in order to meet anticipated customer demand, which carries fixed costs that we may not be able to offset if orders slow, which would adversely affect our operating margins.
−Removed: If we are unable to manufacture our products consistently, in sufficient quantities, and on a timely basis, our revenues, gross margins and our other operating results will be materially and adversely affected.
Acquisition Risks
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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.
−Removed: Promising acquisitions are difficult to identify and complete 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.
−Removed: In addition, competition for acquisitions may result in higher purchase prices.
−Removed: Changes in accounting or regulatory requirements, or instability in the credit markets, or global crisis that prevents travelling or other activities necessary for acquisitions could also adversely impact our ability to consummate acquisitions.
+Added: 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.
+Added: 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.
Our acquisition of businesses could negatively impact our financial statements.
−Removed: As an important part of our business strategy, we acquire businesses, some of which may be material.
−Removed: Please see Item 7.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations  for additional details.
−Removed: These acquisitions involve a number of financial, accounting, managerial, operational, legal, compliance and other risks and challenges, including the following, any of which could adversely affect our business and our financial statements:
+Added: Acquisitions involve a number of financial, accounting, managerial, operational, legal, compliance and other risks and challenges, including the following, any of which could adversely affect our business and our financial statements:
any business, technology, service or product that we acquire could under-perform relative to our expectations and the price that we paid for it, or not perform in accordance with our anticipated timetable, or we could fail to make such business profitable;
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The realization of any of these liabilities or deficiencies may increase our expenses, adversely affect our financial position or cause us to fail to meet our public financial reporting obligations;
−Removed: in connection with acquisitions, we often enter into post-closing financial arrangements such as purchase price adjustments, earn-out obligations and indemnification obligations, which may have unpredictable financial results;
+Added: in connection with acquisitions, we may enter into post-closing financial arrangements such as purchase price adjustments, earn-out obligations and indemnification obligations, which may have unpredictable financial results;
as a result of our acquisitions, we have recorded significant goodwill and intangible assets on our balance sheets.
If we are not able to realize the value of these assets, we may be required to incur charges relating to the impairment of these assets, which could materially impact our financial results.
−Removed: If intangible assets and goodwill that we recorded in connection with our acquisitions become impaired, we may have to take significant charges against earnings.
−Removed: In connection with the accounting for our completed acquisitions, we recorded a significant amount of intangible assets, including developed technology and customer relationships relating to the acquired product lines, and goodwill.
−Removed: Under accounting principles generally accepted in the United States (“GAAP”), we must assess, at least annually and potentially more frequently, whether the value of intangible assets and goodwill has been impaired.
−Removed: Intangible assets and goodwill will be assessed for impairment in the event of an impairment indicator.
−Removed: Any reduction or impairment of the value of intangible assets and goodwill will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’
−Removed: equity in future periods.
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.
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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.
−Removed: Future strategic transactions or acquisitions may require us to seek additional financing, which we may not be able to secure on favorable terms, if at all.
+Added: Future strategic transactions or acquisitions may require us to seek additional financing, which we may not be able to secure on favorable terms, or at all.
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.
−Removed: In addition, future acquisitions may require the issuance or sale of additional equity or debt securities, which may result in additional dilution to our stockholders.
+Added: In addition, future acquisitions may require the issuance or sale of additional equity or debt securities, which may result in dilution to our stockholders.
Legal, Regulatory, Compliance, and Reputational Risks
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Moreover, any insurance or indemnification rights that we may have may be insufficient or unavailable to protect us against such losses.
−Removed: In addition, developments in proceedings in any given period may require us to adjust the loss contingency estimates that we have recorded in our financial statements, record estimates for liabilities or assets previously not susceptible of reasonable estimates or pay cash settlements or judgments.
+Added: In addition, developments in proceedings in any given period may require us to adjust loss contingency estimates that we have recorded in our financial statements, record estimates for liabilities or assets previously not susceptible of reasonable estimates or pay cash settlements or judgments.
Any of these developments could adversely affect our financial results in any given period.
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Please see Note 13. “Commitments and Contingencies”
−Removed: of Notes to Consolidated Financial Statements contained in Item 8.
+Added: of the Notes to Consolidated Financial Statements contained in Item 8.
Financial Statements and Supplementary Data for additional discussion.
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In addition, we or our customers may be alleged to infringe upon the intellectual property of third parties.
−Removed: Our failure to obtain or maintain intellectual property rights that convey competitive advantage, adequately protect our intellectual property, detect or prevent circumvention or unauthorized use of such property, and the cost of enforcing our intellectual property rights or defending against any allegation of infringement, could adversely impact our competitive position and results of operations.
+Added: Our failure to obtain or maintain intellectual property rights that convey competitive advantages, adequately protect our intellectual property, detect or prevent circumvention or unauthorized use of such property, and limit the cost of enforcing our intellectual property rights or defending against any allegation of infringement, could adversely impact our competitive position and results of operations.
We are subject to extensive regulation.
The process of obtaining and maintaining required regulatory approvals is lengthy, expensive and uncertain.
−Removed: We can offer no assurance that delays will not occur in the future, which could have a significant adverse effect on our ability to introduce new products on a timely basis.
+Added: 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”
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Failure to comply with applicable regulatory requirements can, among other things, result in fines, suspension of regulatory approvals, product recalls, operating restrictions and criminal penalties.
−Removed: If we fail to comply with regulatory requirements, it could have an adverse effect on our results of operations and financial condition. The regulations we are subject to have tended to become more stringent over time and may be inconsistent across jurisdictions.
−Removed: We, our representatives and the industries in which we operate may at times be under review and/or investigation by regulatory authorities.
−Removed: Compliance with applicable regulations may affect our returns on investment, require us to incur significant expenses or modify our business model or impair our flexibility in modifying product, marketing, pricing or other strategies for growing our business.
+Added: If we fail to comply with regulatory requirements, it could have an adverse effect on our results of operations and financial condition. We, our representatives and the industries in which we operate may at times be under review and/or investigation by regulatory authorities.
+Added: Compliance with applicable regulations may affect our returns on investment, require us to incur significant expenses or modify our business model or impair our flexibility in modifying product, marketing, pricing or other strategies.
Our products and operations are also often subject to the rules of industrial standards bodies such as the International Standards Organization, and failure to comply with these rules could result in withdrawal of certifications needed to sell our products and services and otherwise adversely impact our business and financial statements. 
Certain of our products are medical devices and other products subject to regulation by the U.S.
−Removed: FDA, by other federal and state governmental agencies, by comparable agencies of other countries and regions.
−Removed: We cannot guarantee that we will be able to obtain regulatory clearance (such as 510(k) clearance) or approvals for our 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.
+Added: FDA, by other federal and state governmental agencies, or by comparable agencies of other countries and regions.
+Added: 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.
−Removed: For example, the EU Medical Device Regulation (the “EU MDR”) imposes strict requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems and post-market surveillance.
−Removed: Failure to meet the requirements could adversely impact our business in the EU and other regions that tie their product registrations to the EU requirements.
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.
−Removed: 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, reputation damage, business disruption, loss of customers and disbarment from selling to certain federal agencies, criminal prosecutions and other adverse effects.
+Added: 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.
−Removed: Therefore, even if we are successful in defending against any such actions brought against us, our business may be impaired.
+Added: Therefore, even if we are successful in defending against any such actions brought against us, our business may be negatively impacted.
Off-label marketing of our products could result in substantial penalties.
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Product liability suits against us, product defects or unanticipated use or inadequate disclosure with respect to our products or services could adversely affect our business, reputation and our financial statements.
−Removed: Manufacturing or design defects in, unanticipated use of, safety or quality issues (or the perception of such issues) with respect to, or inadequate disclosure of risks relating to the use of products and services that we make or sell (including items that we source from third parties) can lead to personal injury, property damage or other liability.
−Removed: These events could lead to recalls or safety alerts, result in the removal of a product or service from the market and result in product liability or similar claims being brought against us.
−Removed: Recalls, removals and product liability and similar claims (regardless of their validity or ultimate outcome) can result in significant costs, as well as negative publicity and damage to our reputation that could reduce demand for our products and services. Our product liability insurance may not adequately cover our costs arising from defects in our products or otherwise.
+Added: Manufacturing or design defects in, unanticipated use of, safety or quality issues (or the perception of such issues) with respect to, or inadequate disclosure of risks relating to the use of products and services that we make or sell, including items that we source from third parties, can lead to personal injury, property damage or other liability.
+Added: These events could lead to recalls or safety alerts, the removal of a product or service from the market and product liability or similar claims being brought against us.
+Added: Recalls, removals and product liability and similar claims, regardless of their validity or ultimate outcome, can result in significant costs, as well as negative publicity and damage to our reputation that could reduce demand for our products and services. Our product liability insurance may not adequately cover our costs arising from defects in our products or otherwise.
We are subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulations.
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export controls and sanctions regulations that restrict the shipment or provision of certain products and services to certain countries, governments, and persons.
−Removed: While we take precautions to prevent our products and services from being exported in violation of these laws, we cannot guarantee that the precautions we take will prevent violations of export control and sanctions laws.
+Added: While we take precautions to prevent our products and services from being exported in violation of these laws, we cannot guarantee that the precautions we take will prevent violations.
If we are found to be in violation of U.S.
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Financial and Tax Risks
−Removed: We may be required to recognize additional impairment charges for our goodwill and other intangible assets.
−Removed: As of March 31, 2022, the net carrying value of our goodwill and other intangible assets totaled $541.3 million. In accordance with generally accepted accounting principles, we periodically assess our assets to determine if they are impaired.
−Removed: Significant negative industry or economic trends, disruptions to our business, inability to effectively integrate acquired businesses, unexpected significant changes or planned changes in use of our assets, changes in the structure of our business, divestitures, market capitalization declines, or increases in associated discount rates may impair our goodwill and other intangible assets.
−Removed: Any charges relating to such impairments would adversely affect our financial statements in the periods recognized.
+Added: We have identified material weaknesses in our internal control over financial reporting.
+Added: If we are unable to develop and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which may adversely affect investor confidence in our financial reporting and adversely affect our business and operating results and the market price for our common stock.
+Added: Under Section 404 of the Sarbanes-Oxley Act of 2002 and rules promulgated by the SEC, companies are required to conduct an annual comprehensive evaluation of their internal control over financial reporting.
+Added: Further, each year our independent registered public accounting firm is required to attest to and report on the effectiveness of our internal control over financial reporting.
+Added: Management concluded that as of March 31, 2023, our internal control over financial reporting was not effective. As described in "Part II, Item 9A —
+Added: Controls and Procedures," we identified two material weaknesses in the design and operation of our internal control over financial reporting whereby (i) Management's review controls over fair value calculations including Management's preliminary valuation of the Belyntic Acquisition were insufficient, and (ii) Management's review controls over the qualitative assessment of goodwill impairment were insufficient to identify potential impairment triggers. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
+Added: As a result of these material weaknesses, management has concluded that our disclosure controls and procedures were not effective as of March 31, 2023.
+Added: The material weaknesses will not be considered remediated until management designs and implements effective controls, namely Management must use a valuation specialist to perform the final valuation over the net assets acquired in the Belyntic acquisition prior to the end of the measurement period and implement well documented evaluation of its process to monitor for triggers of potential impairment.
+Added: We expect our remediation efforts to be effective, however, we can provide no assurance that they will be or that additional material weaknesses will not arise in the future. The existence of these material weaknesses and of any other ineffective controls over our financial reporting could have negative impacts including one or more of the following:
+Added: Restatement of previously filed financial statements;
+Added: Failure to meet our reporting deadlines (which among other consequences would result in a default of our convertible Notes due 2025);
+Added: Loss of investor confidence;
+Added: Restrict our ability to access capital markets;
+Added: Require us to expend significant resources to correct the deficiencies;
+Added: Negative impact on the trading price of our common stock.
Foreign currency exchange rates may adversely affect our financial statements.
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dollar could result in unfavorable translation effects.
−Removed: In addition, certain of our businesses may invoice customers in a currency other than the business’
−Removed: functional currency, and movements in the invoiced currency relative to the functional currency could also result in unfavorable translation effects.
+Added: In addition, certain of our businesses may invoice customers in a currency other than their functional currency, and movements in the invoiced currency relative to the functional currency could also result in unfavorable translation effects.
We also face exchange rate risk from our investments in subsidiaries owned and operated in foreign countries.
We do not enter into hedging arrangements to mitigate any foreign currency exposure.
+Added: We may be required to recognize impairment charges for our goodwill and other intangible assets.
+Added: As of March 31, 2023, the net carrying value of our goodwill and other intangible assets totaled $503.3 million.
+Added: Significant negative industry or economic trends, disruptions to our business, loss of major customers, strategic shifts in our business, inability to effectively integrate acquired businesses, unexpected significant changes or planned changes in use of our assets, changes in the structure of our business, divestitures, market capitalization declines, or increases in associated discount rates may impair our goodwill and other intangible assets.
+Added: Any charges relating to such impairments would adversely affect our financial statements in the periods recognized.
+Added: The loss of key customers, or reductions in their demand for our products and services, could have a significant negative impact on our revenues, results of operations, and financial position.
+Added: Certain of our reporting segments sell to customers who individually comprise greater than 10% of segment revenues.
+Added: Our business, financial condition or results of operations could be adversely affected by the loss of any such customers, or by a reduction in their purchases of our products and services due to downturns in their business, changes in their business strategies, reduced capital spending, unfavorable macroeconomic conditions, or other factors.
Changes in accounting standards could affect our reported financial results.
−Removed: New accounting standards or pronouncements that may become applicable to our Company from time to time, or changes in the interpretation of existing standards and pronouncements, could have a significant effect on our reported results of operations for the affected periods. 
−Removed: Changes in our tax rates or exposure to additional income tax liabilities or assessments could affect our profitability.
−Removed: In addition, audits by tax authorities could result in additional tax payments for prior periods.
−Removed: We are subject to income taxes in the U.S.
−Removed: and in various non-U.S.
−Removed: jurisdictions. The amount of income taxes we pay is subject to ongoing audits by U.S.
−Removed: federal, state and local tax authorities and by non-U.S.
−Removed: tax authorities, such as those audits described elsewhere in this report. If audits result in payments or assessments different from our reserves, our future results may include unfavorable adjustments to our tax liabilities and our financial statements could be adversely affected. Any further significant changes to the tax system in the United States or in other jurisdictions (including changes in the taxation of international income as further described below) could adversely affect our financial statements.
+Added: New accounting standards or pronouncements that may become applicable from time to time, or changes in the interpretation of existing standards and pronouncements, could have a significant effect on our reported results of operations for the affected periods. 
If we fail to maintain an effective system of internal controls, we may not be able to accurately report financial results or prevent fraud.
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Any system of internal controls, however well designed and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that the objectives of the system are met.
−Removed: If we, or our independent registered public accounting firm, determine that our internal control over financial reporting is not effective, discover areas that need improvement in the future or discover a material weakness, these shortcomings could have an adverse effect on our business and financial results, and the price of our common stock could be negatively affected.
−Removed: A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
−Removed: Accordingly, a material weakness increases the risk that the financial information we report contains material errors.
−Removed: If we cannot conclude that we have effective internal control over our financial reporting, or if our independent registered public accounting firm is unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in the reliability of our financial statements, which could lead to a decline in our stock price.
+Added: If we, or our independent registered public accounting firm, determine that our internal control over financial reporting is not effective, discover areas that need improvement in the future or discover a material weakness, as was the case as of March 31, 2023, these shortcomings could have an adverse effect on our business and financial results, and the price of our common stock could be negatively affected.
Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by the SEC, the Nasdaq Stock Market or other regulatory authorities.
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The implementation of these systems represents a change in our internal control over financial reporting.
−Removed: Although we continue to monitor and assess our internal controls environment as changes are made and new modules are implemented, and we have taken additional steps to modify and enhance the design and effectiveness of our internal control over financial reporting, there is a risk that deficiencies may occur that could aggregate to a material weakness.
+Added: Although we continue to monitor and assess our internal control environment as changes are made, and we have taken steps to modify and enhance the design and effectiveness of our internal control over financial reporting, there is a risk that deficiencies may occur that could aggregate to a material weakness specifically related to our information technology general controls.
If we fail to remedy any deficiencies or maintain the adequacy of our internal controls, we could be subject to regulatory scrutiny, civil or criminal penalties or shareholder litigation.
In addition, failure to maintain adequate internal controls could result in financial statements that do not accurately reflect our operating results or financial condition.
+Added: Our failure to maintain appropriate environmental, social, and governance ("ESG") practices and disclosures could result in reputational harm, a loss of customer and investor confidence, and adverse business and financial results.
+Added: Governments, investors, customers, and employees are enhancing their focus on ESG practices and disclosures, and expectations in this area are rapidly evolving and increasing.
+Added: While we monitor the various and evolving standards and associated reporting requirements, failure to adequately maintain appropriate ESG practices that meet stakeholder expectations may result in reputational harm, loss of business, reduced market valuation, an inability to attract customers, and an inability to attract and retain top talent.
+Added: Changes in our tax rates or exposure to additional income tax liabilities or assessments could affect our profitability.
+Added: In addition, audits by tax authorities could result in additional tax payments for prior periods.
+Added: We are subject to income taxes in the U.S.
+Added: and in various non-U.S.
+Added: jurisdictions. The amount of income taxes we pay is subject to ongoing audits by U.S.
+Added: federal, state and local tax authorities and by non-U.S.
+Added: tax authorities, such as those audits described elsewhere in this report. If audits result in payments or assessments different from our reserves, our future results may include unfavorable adjustments to our tax liabilities and our financial statements could be adversely affected. Any further significant changes to the tax system in the United States or in other jurisdictions (including changes in the taxation of international income as further described below) could adversely affect our financial statements.
Our ability to use net operating losses and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code, and it is possible that certain transactions or a combination of certain transactions may result in material additional limitations on our ability to use our net operating loss and tax credit carryforwards.
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Generally, if an ownership change occurs, the yearly taxable income limitation on the use of net operating loss and tax credit carryforwards and certain built-in losses is equal to the product of the applicable long-term, tax-exempt rate and the value of the company’s stock immediately before the ownership change.
−Removed: We may be unable to offset our taxable income with losses, or our tax liability with credits, before such losses and credits expire and therefore would incur larger federal income tax liability.
−Removed: We are in the process of conducting a new Section 382 study as a result of the acquisition of Agena, and while our most recent Section 382 analysis did not show any current exposure, future transactions or combinations of future transactions may result in a change in control under Section 382.
−Removed: Federal net operating losses generated after December 31, 2017 are not subject to expiration and generally may not be carried back to prior taxable years except that, under the Coronavirus Aid, Relief, and Economic Security Act, net operating losses generated in 2018, 2019 and 2020 may be carried back five taxable years.
−Removed: Additionally, for taxable years beginning after March 31, 2021, the deductibility of such deferral net operating losses is limited to 80% of our taxable income in any future taxable year.
+Added: We may be unable to offset our taxable income with losses, or our tax liability with credits, before such losses and credits expire and therefore would incur larger federal income tax liability. Federal net operating losses generated after December 31, 2017 are not subject to expiration and generally may not be carried back to prior taxable years except that, under the Coronavirus Aid, Relief, and Economic Security Act, net operating losses generated in 2018, 2019 and 2020 may be carried back five taxable years.
+Added: Additionally, for taxable years beginning after March 31, 2021, the deductibility of such deferral net operating losses is limited to 80% of our taxable income in any future taxable year. 
Changes in tax law relating to multinational corporations could adversely affect our tax position.
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The OECD has released several components of its comprehensive plan to create an agreed set of international rules for addressing base erosion and profit shifting.
−Removed: As a result, the tax laws in the United States and other countries in which we do business could change on a prospective or retroactive basis, and any such changes could adversely affect our business and financial statements.  
+Added: As a result, the tax laws in the United States and other countries in which we do business could change on a prospective or retroactive basis, and any such changes could adversely affect our business and financial statements. 
Our business is subject to sales tax in numerous states.
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Servicing our debt will require a significant amount of cash, and we may not have sufficient cash flow from our business or the ability to raise capital to repay our 1.375% convertible senior notes due August 15, 2025 (the “2025 Notes”) at maturity or repurchase the notes in the event of a fundamental change , or if we borrow under our credit facility, swingline loan, and letters of credit (together referred to as the "Credit Facility") or if we incur more debt.
−Removed: We incurred significant indebtedness in the amount of $172,500 in the form of the Notes which mature on August 15, 2025, unless earlier converted. We also have a revolving Credit Facility and could borrow additional amounts under that at any time, incurring more debt.
−Removed: We currently expect to settle future conversions solely in shares of our common stock, which has the effect of including the shares of common stock issuable upon conversion of the Notes in our diluted earnings per share to the extent such shares are not anti-dilutive.
−Removed: We will reevaluate this policy from time to time in the event conversion notices are received from Note holders and if our stock price is above the strike price.
+Added: We incurred significant indebtedness in the amount of $172.5 million in the form of the 2025 Notes which mature on August 15, 2025, unless earlier converted. We also have a revolving Credit Facility and could borrow additional amounts under that at any time, incurring more debt.
+Added: At our option, we may settle the 2025 notes in shares of our common stock, cash, or a combination thereof.
Holders of the 2025 Notes also have the right to require us to repurchase all or a portion of their 2025 Notes upon the occurrence of a fundamental change (as defined in the applicable indenture governing the 2025 Notes) at a repurchase price equal to 100% of the principal amount of the 2025 Notes to be repurchased, plus accrued and unpaid interest.
−Removed: In addition, if the Notes have not previously been converted or repurchased due to a decline in share price, we will be required to repay the Notes in cash.
+Added: In addition, if the 2025 Notes have not previously been converted or repurchased due to a decline in our share price, we may be required to repay the 2025 Notes in cash.
Our ability to make required cash payments in connection with conversions of the 2025 Notes, repurchase the 2025 Notes in the event of a fundamental change, or to repay or refinance the 2025 Notes at maturity will depend on market conditions and our future performance, which is subject to economic, financial, competitive, and other factors beyond our control.
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A default under the indenture or agreements governing our future indebtedness could have a material adverse effect on our business, results of operations, and financial condition.
−Removed: If the payment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Notes or to pay cash upon conversion or at maturity of the Notes.
+Added: If the payment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the 2025 Notes or to pay cash upon conversion or at maturity.
Additional stock issuances could result in significant dilution to our stockholders.
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The amount of dilution due to equity-based compensation of our employees and other additional issuances could be substantial.
−Removed: In addition, in March 2022, we entered a sales agreement with Jefferies LLC ("Jefferies") to sell shares of our common stock, from time to time, with aggregate gross sales proceeds up to $150.0 million through an at-the-market equity offering program under which Jefferies will act as our sales agent. If we issue common stock or securities convertible into common stock for the above reasons, or any other reason, our common stockholders would experience additional dilution and, as a result, our stock price may decline. 
+Added: In addition, in March 2022, we entered a sales agreement with Jefferies LLC ("Jefferies") to sell shares of our common stock, from time to time, with aggregate gross sales proceeds up to $150.0 million through an at-the-market equity offering program under which Jefferies will act as our sales agent.
+Added: Further, we may settle all or a portion of the 2025 Notes in shares or in cash, at our option.
+Added: We include shares of common stock issuable upon conversion of the 2025 Notes in our diluted earnings per share to the extent such shares are not anti-dilutive.
+Added: We will reevaluate this policy from time to time if we conclude we intend to settle all or a portion of the 2025 notes in cash, or in the event conversion notices are received from noteholders and our stock price is above the strike price. If we issue common stock or securities convertible into common stock for the above reasons, or any other reason, our common stockholders would experience additional dilution and, as a result, our stock price may decline. 
Our stock price may be volatile, which may subject us to a securities class action litigation.
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changes in earnings estimates or recommendations by securities analysts;
−Removed: investor perceptions of us and our business, including changes in market valuations of medical device companies;
+Added: investor perceptions of us and our business, including changes in market valuations of medical device companies generally;
our results of operations and financial performance.
−Removed: In addition, the stock market in general, and the Nasdaq Stock Market and the market for products and devices sold into the medical and healthcare industries in particular, have experienced substantial price and volume volatility that is often seemingly unrelated to the operating performance of particular companies.
−Removed: These broad market fluctuations may cause the trading price of our common stock to decline.
−Removed: In the past, securities class action litigation has often been brought against a company after a period of volatility in the market price of its common stock.
+Added: In addition, the stock market in general, and the Nasdaq Stock Market and the market for products and devices sold into the medical and healthcare industries in particular, have experienced substantial price and volume volatility that is often seemingly unrelated to the operating performance of particular companies, including recently in connection with the ongoing COVID-19 pandemic, the conflict in Ukraine and increased inflation and interest rates in the United States, which have resulted in decreased stock prices for many companies notwithstanding the lack of a fundamental change in their underlying business models or prospects.
+Added: These broad market fluctuations may cause the trading price of our common stock to decline, regardless of our actual operating performance.
+Added: In the past, securities class action litigation has at times been brought against a company after a period of volatility in the market price of its common stock.
We may become involved in this type of litigation in the future.
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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.