3 unchanged sentences
These other risks include additional uncertainties not presently known to us or that we currently believe are immaterial, but may ultimately have a significant impact.
−Removed: In addition, the impacts of the COVID-19 pandemic, Russia’s invasion of Ukraine and the ongoing inflationary environment may also exacerbate any of these risks, which could have a material effect on us.
+Added: In addition, the impacts of ongoing geopolitical conflicts, including the Russia-Ukraine and Israel-Hamas military conflicts, and the ongoing inflationary environment may also exacerbate any of these risks, which could have a material effect on us.
Although the risks are organized by headings, and each risk is discussed separately, many are interrelated.
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Changes in economic climate may adversely affect us.
−Removed: Adverse economic cycles or conditions, and Customer, regulatory or government response to those cycles or conditions, have affected and could further affect our results of operations.
+Added: Adverse economic cycles or conditions, and Customer, regulatory or government responses to those cycles or conditions, have affected and could further affect our results of operations.
The onset of these cycles or conditions may not be foreseeable and there can be no assurance when they will begin to improve after they occur.
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Some of our Customers are governmental entities or other entities that rely on government healthcare systems or government funding.
−Removed: If government funding for healthcare becomes limited or restricted in countries in which we operate, including as a result of the impacts of the COVID-19 pandemic, our Customers may be unable to pay their obligations on a timely basis or to make payment in full and it may become necessary to increase reserves.
+Added: If government funding for healthcare becomes limited or restricted in countries in which we operate, including as a result of the impacts of a pandemic or its residual effects, our Customers may be unable to pay their obligations on a timely basis or to make payment in full and it may become necessary to increase reserves.
In addition, there can be no assurance that there will not be an increase in collection difficulties.
Prospectively, additional adverse effects resulting from these conditions may include decreased healthcare utilization, further pricing pressure on our products and services, and/or weaker overall demand for our products and services, particularly capital products.
−Removed: The effects of geopolitical instability, including as a result of Russia’s invasion of Ukraine, may adversely affect us and create significant risks and uncertainties for our business, with the ultimate impact dependent on future developments, which are highly uncertain and unpredictable.
−Removed: Ongoing geopolitical instability, including as a result of Russia’s invasion of Ukraine, has negatively impacted, and could in the future negatively impact, the global and U.S.
+Added: The effects of geopolitical instability, including as a result of the Russia-Ukraine and Israel-Hamas military conflicts, may adversely affect us and create significant risks and uncertainties for our business, with the ultimate impact dependent on future developments, which are highly uncertain and unpredictable.
+Added: Ongoing geopolitical instability, including as a result of the Russia-Ukraine and Israel-Hamas military conflicts, has negatively impacted, and could in the future negatively impact, the global and U.S.
economies, including by causing supply chain disruptions, rising energy costs, volatility in capital markets and foreign currency exchange rates, rising interest rates and heightened cybersecurity risks.
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The long-term impact on our business resulting from the disruption of trade in the region caused by the conflict and associated sanctions and boycotts is uncertain at this time due to the fluid nature of the ongoing military conflict and response.
−Removed: The potential impacts include supply chain and logistics disruptions, financial impacts including volatility in foreign exchange and interest rates, increased inflationary pressure on raw materials and energy, and other risks, including an elevated risk of
−Removed: cybersecurity threats and the potential for further sanctions.
+Added: The potential impacts include supply chain and logistics disruptions, financial impacts including volatility in foreign exchange
+Added: and interest rates, increased inflationary pressure on raw materials and energy, and other risks, including an elevated risk of cybersecurity threats and the potential for further sanctions.
We have stopped commercial operations in Russia and Belarus, which includes shipments to Customers and purchases of cobalt-60 from our Russian supplier.
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The COVID-19 pandemic, along with the response to the pandemic by governmental and other actors, disrupted our operations.
−Removed: We have experienced temporary mandatory and voluntary facility closures in certain jurisdictions in which we operate.
−Removed: Furthermore, we have experienced less demand for certain of our products and services as a result of reduced volume of medical procedures, and other factors, which we believe was exacerbated by the impact of stay-at-home orders and government responses to COVID-19.
−Removed: Additionally, the COVID-19 outbreak has caused temporary disruptions and rising costs in our labor supply and supply chain and distribution network.
−Removed: Long-term facility closures or other restrictions could materially adversely affect our ability to adequately staff, supply or otherwise maintain our operations.
−Removed: Such restrictions also may have a substantial impact on our Customers and our sales cycles.
−Removed: The COVID-19 pandemic may put pressure on overall spending for our products and services, and may cause our Customers to modify spending priorities or delay or abandon purchasing decisions.
−Removed: Moreover, because a large number of our employees have been and will continue to work from home routinely, we may be subject to increased vulnerability to cyber and other information technology risks.
+Added: We experienced temporary mandatory and voluntary facility closures in certain jurisdictions in which we operate and experienced less demand for certain of our products and services as a result of reduced volume of medical procedures, and other factors, which we believe was exacerbated by the impact of stay-at-home orders and government responses to COVID-19.
+Added: Additionally, the COVID-19 outbreak caused disruptions and rising costs in our labor supply and supply chain and distribution network.
+Added: The impact of the COVID-19 pandemic and its residual effects continues to evolve and its ultimate duration, severity and disruption to our business, Customers and supply chain, and the related financial impact to us, cannot be accurately forecasted at this time.
+Added: For instance, the enduring effects of the COVID-19 pandemic may put pressure on overall spending for our products and services, and may cause our Customers to modify spending priorities or delay or abandon purchasing decisions.
+Added: Moreover, because a large number of our employees have worked and are expected to continue to work from home routinely, we may be subject to increased vulnerability to cyber and other information technology risks.
We have modified, and may further modify, our business practices in response to the risks and negative impacts associated with the COVID-19 pandemic.
However, there can be no assurance that these measures will be temporary or successful.
−Removed: The impact of the COVID-19 pandemic continues to evolve and its ultimate duration, severity and disruption to our business, Customers and supply chain, and the related financial impact to us, cannot be accurately forecasted at this time.
−Removed: Should such additional significant disruptions occur and continue for an extended period, the adverse effect on our business, results of operations and financial condition could be more severe.
−Removed: Additionally, weak economic conditions, the pace for economic recovery, and rising inflation, could result in extended weak demand for our products and services.
Furthermore, future public health crises are possible and could involve some or all of the risks discussed above.
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In addition, our costs may increase more rapidly than reimbursement levels or permissible pricing increases or we may not satisfy the standards or requirements for reimbursement.
−Removed: Various additional health care reform proposals have emerged at the federal and state level, and we are unable to predict which, if any, of those proposals will be enacted.
+Added: Various additional healthcare reform proposals have emerged at the federal and state level, and we are unable to predict which, if any, of those proposals will be enacted.
Product and Service Related Regulations and Claims
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If there are delays in and/or we are unable to obtain any required approvals, approval supplements or clearances for any modification to a previously cleared or approved device, we may be required to cease manufacturing and sale, or recall or restrict the use of such modified device, pay fines, or take other action until such time as appropriate clearance or approval is obtained.
−Removed: Any elongation or de-prioritization or delay in regulatory review could materially affect our ongoing device design, development, and commercialization plans.
+Added: Any protraction or de-prioritization or delay in regulatory review could materially affect our ongoing device design, development, and commercialization plans.
Regulatory agencies may refuse to grant approval or clearance, or review and disagree with our interpretation of approvals or clearances, or with our decision that regulatory approval is not required or has been maintained.
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Our products are subject to recalls and restrictions, even after receiving United States or foreign regulatory clearance or approval.
−Removed: Ongoing medical device reporting regulations require that we report to appropriate governmental authorities in the United States and/or other countries when our products cause or contribute to a death or serious injury or malfunction in a way that would be reasonably likely to contribute to a death or serious injury if the malfunction were to recur.
+Added: Ongoing medical device reporting regulations require that we report to appropriate governmental authorities in the United States and/or other countries when our products cause or contribute to a death or serious injury or malfunction in a way that would be reasonably likely to contribute to a death or serious injury if the malfunction were to reoccur.
Governmental authorities can require product recalls or impose restrictions for product design, manufacturing, labeling, clearance, or other issues.
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These include compliance matters, product regulation or safety, taxes, employee benefit plans, employment discrimination, health and safety, environmental, antitrust, customs, import/export, government contract compliance, financial controls or reporting, intellectual property, allegations of misrepresentation, false claims or false statements, commercial claims, claims regarding promotion of our products and services, or other similar or different matters.
−Removed: Any such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs, restrictions on product use or sales, or otherwise injure our business.
+Added: Any such claims, proceedings, investigations or litigation, regardless of the merits, might result in substantial costs, restrictions on product use or sales, or otherwise negatively impact our business.
Administratively or judicially imposed or agreed sanctions might include warning letters, fines, civil penalties, criminal penalties, loss of tax benefits, injunctions, product seizure, recalls, suspensions or restrictions, re-labeling, detention, and/or debarment.
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Many other non-EU member countries agreed to adopt GloBE between fiscal years 2024 and 2025.
−Removed: The GloBE rules, once implemented in the EU and other jurisdictions, could subject us to additional income taxes in those jurisdictions if our effective corporate tax rate in those
−Removed: jurisdictions (determined under the GloBE rules) is below 15%.
−Removed: Accordingly, the GloBE rules could increase tax uncertainty and adversely impact our provision for income taxes.
+Added: The GloBE rules, once implemented in the EU and other jurisdictions, could subject us to additional income taxes in those jurisdictions if our effective corporate tax rate in those jurisdictions (determined under the GloBE rules) is below 15%.
+Added: Accordingly, the GloBE rules could increase tax uncertainty and adversely impact our
+Added: provision for income taxes.
In addition, the GloBE rules have certain transition period provisions that apply to certain intercompany transactions occurring between December 1, 2021 and the effective date of the GloBE rules in a given jurisdiction.
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Additionally, tax laws or their implementation and applicable tax authority practices in any particular jurisdiction could change in the future, possibly on a retroactive basis, and any such change could have a material adverse impact on us and our affiliates.
−Removed: In addition, the GloBE rules, which are expected to be implemented in most of the jurisdictions where we have operations, and the CAMT may adversely impact our effective corporate tax rate.
+Added: In addition, the GloBE rules, which have been or are expected to be implemented in most of the jurisdictions where we have operations, and the CAMT may adversely impact our effective corporate tax rate.
Changes in tax treaties and trade agreements could negatively impact our costs, results of operations and earnings per share.
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On June 7, 2017, several countries, including many countries that we operate and have subsidiaries in, adopted the OECD’s Multilateral Convention to Implement Tax Treaty Related Measures to Prevent Base Erosion and Profit Shifting (the "MLI"), which generally is meant to prevent treaty abuse, improve dispute resolution, prevent the artificial avoidance of permanent establishment status and neutralize the effect of hybrid mismatch agreements.
−Removed: The MLI came into effect on July 1, 2018.
−Removed: The MLI may modify affected tax treaties making it more difficult for us to obtain advantageous tax-treaty benefits.
+Added: The MLI came into affect on July 1, 2018.
+Added: The MLI may modify effected tax treaties making it more difficult for us to obtain advantageous tax-treaty benefits.
The number of affected tax treaties could eventually be significant.
−Removed: To date, about 100 jurisdictions have joined the BEPS MLI, out of which about 79 jurisdictions have ratified, accepted, or approved the MLI, and it covers around 1850 bilateral tax treaties.
+Added: To date, more than 100 jurisdictions have joined the BEPS MLI, out of which most jurisdictions have ratified, accepted, or approved the MLI, and it covers around 1,850 bilateral tax treaties.
Signatories include jurisdictions from all continents and all levels of development and other jurisdictions are also actively working towards signature.
1 unchanged sentence
Existing free trade laws and regulations provide certain beneficial duties and tariffs for qualifying imports and exports, subject to compliance with the applicable classification and other requirements.
−Removed: Changes in laws and regulations or policies governing the terms of foreign trade, and in particular, increased trade restrictions, including as a result of the COVID-19 pandemic, tariffs or taxes on imports from countries where we manufacture products could have a material adverse impact on our business and financial results.
+Added: Changes in laws and regulations or policies governing the terms of foreign trade, and in particular, increased trade restrictions, tariffs or taxes on imports from countries where we manufacture products could have a material adverse impact on our business and financial results.
Proposed legislation relating to the denial of U.S.
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federal tax purposes, non-U.S.
−Removed: holders of our ordinary shares would be subject to U.S.
+Added: holders of our
+Added: ordinary shares would be subject to U.S.
withholding tax on the gross amount of any dividends we paid to such shareholders.
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Additional consolidations could result in a loss of Customers or more significant pricing pressures.
−Removed: Decreased availability or increased costs of raw materials or energy supplies or other supplies might increase our production costs or limit our production capabilities or curtail our operations.
+Added: Supply chain disruption might increase our production costs, limit our production capabilities or curtail our operations.
We purchase raw materials, fabricated and other components, and energy supplies from a variety of suppliers.
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Some are single-sourced in certain regions of the world, such as cobalt-60 and EO, which are necessary to our AST operations.
−Removed: Changes in regulatory requirements regarding the use of, the unavailability or short supply of these products might disrupt or cause shutdowns of portions of our AST operations or have other adverse consequences.
+Added: Changes in regulatory requirements regarding the use of, or the unavailability or short supply of, these products might disrupt or cause shutdowns of portions of our AST operations or have other adverse consequences.
Shortages in supply, increased regulatory or security requirements, or increases in the price of raw materials, components and energy supplies may adversely affe ct us.
−Removed: In response to the active conflict between Russian and Ukraine, we have stopped purchasing cobalt-60 from our Russian supplier.
+Added: In response to the active Russia-Ukraine military conflict, we have stopped purchasing cobalt-60 from our Russian supplier.
A long-term disruption in cobalt-60 sourced from Russia may negatively impact gamma processing capacity or increase costs in certain portions of our AST operations.
1 unchanged sentence
Business continuity hazards and other risks include:
−Removed: explosions, fires, earthquakes, public health crises, inclement weather, and other disasters;
+Added: explosions, fires, earthquakes, public health crises, extreme weather conditions, and other disasters;
utility or other mechanical failures;
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The occurrence of these types of events has disrupted and may in the future disrupt or shut down operations, or otherwise adversely impact the production or profitability of a particular facility, or our operations as a whole.
−Removed: Certain casualties also might cause personal injury and loss of life, or severe damage to or destruction of property and equipment, and for casualties occurring at our facilities, result in liability claims against us.
+Added: These events also might cause personal injury and loss of life, or severe damage to or destruction of property and equipment, and for injuries occurring at our facilities or as a result of actions of our employees, result in liability claims against us.
Although we maintain property and casualty insurance and liability and similar insurance of the types and in the amounts that we believe are customary for our industries, our insurance coverages have limits and we are not fully insured against all potential hazards and risks incident to our business.
−Removed: Expectations relating to ESG considerations expose us to potential liabilities, increased costs, reputational harm and other adverse effects on our business.
−Removed: Many governments, regulators, investors, employees, Customers and other stakeholders are increasingly focused on ESG considerations relating to businesses, including climate change and greenhouse gas emissions, human capital and diversity, equity and inclusion.
+Added: Expectations relating to Corporate Responsibility considerations expose us to potential liabilities, increased costs, reputational harm and other adverse effects on our business.
+Added: Many governments, regulators, investors, employees, Customers and other stakeholders are increasingly focused on ESG considerations relating to businesses, including climate change and greenhouse gas emissions, human capital and diversity,
+Added: equity and inclusion.
We make statements about our ESG priorities and initiatives through information provided on our website, press statements and other communications.
−Removed: Responding to these ESG considerations and implementation of these initiatives involves risks and uncertainties requires investments and is impacted by factors that may be outside our control.
+Added: Responding to these ESG considerations and implementation of these laws, regulations and other initiatives involves risks and uncertainties, requires significant investments and is impacted by factors that may be outside our control.
In addition, some stakeholders may disagree with our priorities and initiatives and the focus of stakeholders may change and evolve over time.
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As we continue to focus on developing our ESG practices, such practices may not meet the standards of all of our stakeholders and advocacy groups may campaign for further changes.
−Removed: Many of our Customers are also committing to long-term targets to reduce greenhouse gas emissions within their supply chains.
−Removed: If we are unable to support Customers in achieving these reductions, we may lose revenue if our Customers find other suppliers who are better able to support such reductions.
+Added: Many of our Customers are also committing to, and may become subject to legal or regulatory requirements with respect to, long-term targets to reduce greenhouse gas emissions within their supply chains and associated emissions reporting.
+Added: If we are unable to support Customers in fulfilling these obligations or achieving reductions, we may lose revenue if our Customers find other suppliers who are better able to support such efforts.
A failure, or perceived failure, to respond to expectations of all key stakeholders could cause harm to our business and reputation and have a negative impact on the market price of our ordinary shares.
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Many different organizations are promulgating reporting standards and rules that focus on addressing greenhouse gas emissions and climate-related topics.
−Removed: In March 2022, the SEC published its proposed rule, “The Enhancement and Standardization of Climate-Related Disclosures for Investors,” which sets forth certain prescriptive rules that, if implemented as proposed, will significantly increase our reporting obligations and cost of compliance.
+Added: In March 2024, the SEC adopted its final rule, “The Enhancement and Standardization of Climate-Related Disclosures for Investors,” which sets forth certain prescriptive rules that would significantly increase our reporting obligations and cost of compliance.
+Added: Subsequently, the SEC voluntarily stayed the implementation of such rules pending the completion of judicial review by the Court of Appeals for the Eighth Circuit, and it is unclear whether the final rules will be implemented in whole, in part or at all.
On January 5, 2023, the European Commission’s Corporate Sustainability Reporting Directive (“CSRD”) became effective.
−Removed: The CSRD expands the number of companies required to publicly report ESG-related information and defines the ESG-related information that companies are required to report in accordance with European Sustainability Reporting Standards (“ESRS”).
+Added: The CSRD expands the number of companies required to publicly report ESG-related information, defines the ESG-related information that companies are required to disclose in accordance with European Sustainability Reporting Standards (“ESRS”) and imposes additional assurance obligations with respect to such disclosures.
While CSRD rules are prescriptive for the types of data to be reported, the standards to quantify and qualify such data are still developing and uncertain, and may impose increased costs on us related to complying with our reporting obligations and increase risks of non-compliance with ESRS and the CSRD.
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Our AST segment is a technology-neutral contract sterilization service that offers our Customers a wide range of sterilization modalities through a worldwide network of over 50 contract sterilization and laboratory facilities.
−Removed: One of the modalities offered by our AST operations is ethylene oxide (EO) sterilization.
+Added: One of the modalities offered by our AST operations is EO sterilization.
In the United States, several regulators, including the EPA, FDA, and agencies at the state and local level, play a role in regulating the use of EO sterilization.
In 2016, the EPA changed the cancer risk basis for EO and determined that EO is carcinogenic to humans.
−Removed: Recent announcements of the temporary or permanent closure of EO sterilization facilities operated by others have been associated with state and/or local regulatory or other legal action related to EO emissions at those facilities.
−Removed: Our AST operations have taken and will continue to take measures to comply with all applicable emissions regulations and to reduce emissions.
−Removed: However, no assurance can be given that current or future legislative or regulatory action, or current or future litigation to which we are or may become a
−Removed: party, will not significantly increase the costs of conducting our EO contract sterilization operations or curtail or eliminate the use of EO in our contract sterilization operations.
+Added: Announcements of the temporary or permanent closure of EO sterilization facilities operated by others have been associated with state and/or local regulatory or other legal action related to EO emissions at those facilities.
+Added: Our AST operations have taken and will continue to take measures to comply
+Added: with all applicable emissions regulations and to reduce emissions.
+Added: However, no assurance can be given that current or future legislative or regulatory action, or current or future litigation to which we are or may become a party, will not significantly increase the costs of conducting our EO contract sterilization operations or curtail or eliminate the use of EO in our contract sterilization operations.
A significant reduction in our EO contract sterilization activities may have a material adverse effect on our financial condition and results of operations.
−Removed: Further, we could be liable for damages and fines as a result of legislative or regulatory action or litigation, and any liability could exceed our insurance and indemnification coverage, if any, and have a material adverse effect on our financial condition.
+Added: Further, we could be liable for material damages and fines as a result of legislative or regulatory action or litigation, and any liability could exceed our insurance and indemnification coverage, if any, and have a material adverse effect on our financial condition.
Additionally, for many medical devices, EO sterilization may be the only current method of sterilization that effectively sterilizes and does not damage the device during the sterilization process.
2 unchanged sentences
Our EO sterilization operations subject us to claims of liability and associated adverse effects .
−Removed: Some current or past operators of EO sterilization facilities, including us, have been the target of litigation on behalf of private plaintiffs alleging personal and other injuries as a result of exposure to emissions from such facilities.
−Removed: Certain of those operators have experienced adverse judgments and entered into settlements.
+Added: Some current or past operators of EO sterilization facilities, including us, have been the target of litigation on behalf of private plaintiffs alleging personal and other injuries as a result of exposure to emissions from such facilities and have experienced adverse judgments and entered into settlements.
These developments may increase the likelihood that we will continue to be subject to these claims or that we will be subject to more claims on behalf of similar plaintiffs in the future.
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Increases in costs of doing business may have a material adverse effect on our financial condition and results of operations.
−Removed: A pandemic or similar public health crises, such as COVID-19, could have a material adverse impact on ability to staff our operations.
+Added: A pandemic or similar public health crisis could have a material adverse impact on our ability to staff our operations.
As supplier to Healthcare and Life Sciences Customers, we fell within a “critical infrastructure” sector, and were also considered an essential business and therefore were exempt under various stay-at -home/shelter-in-place orders associated with COVID-19.
−Removed: These exemptions, however, may not persist in another pandemic or similar health crisis and there can be no assurance that in such a crisis, we will be able to operate in the same.
−Removed: During the COVID-19 pandemic, our employees continued to work because of the importance of our operations to the health and well-being of citizens in the countries in which we operate, and we implemented telework policies wherever possible for appropriate categories of employees.
−Removed: While based on our response to the current COVID-19 pandemic, we believe that we have developed appropriate measures to ensure the health and well-being of our employees for similar or future health crises, there can be no assurances that our measures will be sufficient to protect our employees in our workplace or that they may not otherwise be exposed to an illness outside of our workplace.
−Removed: If a number of our essential employees become ill, incapacitated or are otherwise unable or unwilling to continue working during the current or any future health crises, our operations may be adversely impacted.
+Added: These exemptions, however, may not be available in another pandemic or similar health crisis and there can be no assurance that in such a crisis, we will be able to operate in the same manner.
+Added: While we believe that we have developed appropriate measures to ensure the health and well-being of our employees for future health crises, there can be no assurances that our measures will be sufficient to protect our employees in our workplace or that they may not otherwise be exposed to an illness outside of our workplace.
+Added: If a large or otherwise impactful number of our employees become ill, incapacitated or are otherwise unable or unwilling to continue working during the current or any future health crises, our operations may be adversely impacted.
Our business and results of operations may be adversely affected if we are unable to recruit and retain qualified management and other personnel or other compliance matters adversely impact our personnel.
1 unchanged sentence
Labor market conditions, particularly in the United States, are challenging.
−Removed: The undersupply of highly qualified people has led to increased competition, which has led to higher costs and other labor-related difficulties.
+Added: The shortage of highly qualified people has led to increased competition, which has led to higher costs and other labor-related difficulties.
There is no assurance that we will be successful in attracting or retaining replacements to fill vacant positions, successors to fill retirements or employees moving to new positions, or other highly qualified personnel.
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We could experience a failure of a key information technology system, process or site or a breach of information security, including a cybersecurity breach or failure of one or more key information technology systems, networks, processes, associated sites or service providers.
−Removed: We rely extensively on information technology (IT) systems to conduct business, including but not limited to interact with Customers and suppliers, fulfilling orders, generating invoices, collecting and making payments, shipping products, providing Customer support, and fulfilling contractual obligations.
−Removed: In addition, we rely on networks and services, including internet sites, cloud and software-as-a-service solutions, data hosting and processing facilities and tools and other hardware, software and technical applications and platforms, some of which are managed, hosted, provided and/or used by third-parties or their vendors, to assist in conducting our busines s.
+Added: We rely extensively on information technology (“IT”) systems to conduct business, including but not limited to interacting with Customers and suppliers, fulfilling orders, generating invoices, collecting and making payments, shipping products, providing Customer support, and fulfilling contractual obligations.
+Added: In addition, we rely on networks and services, including internet sites, cloud and software-as-a-service solutions, data hosting, electronic payment systems, and processing facilities and tools and other hardware, software and technical applications and platforms, including some that employ artificial intelligence (“AI”), some of which are managed, hosted, provided and/or used by third-parties or their vendors, to assist in conducting our busines s.
While we have been the previous target of cyberattacks and security breaches, none of these attacks or breaches to date have had a material adverse effect on the Company.
4 unchanged sentences
While we have made investments seeking to address these threats, including monitoring of networks and systems, hiring of exp erts, employee training and security policies for employees and third-party providers, the techniques used in these attacks change frequently and may be difficult to detect for periods of time and we may face difficulties in anticipating and implementing adequate preventative measures.
−Removed: When cybersecurity incidents occur, we expect to follow our incident response protocols and address them in accordance with applicable governmental regulations and other legal requirements.
+Added: When cybersecurity incidents occur, we expect to follow our incident response policy and address them in accordance with applicable governmental regulations and other legal requirements.
Our response to these incidents and our investments to protect our information technology infrastructure and data may not shield us from significant losses and potential liability or prevent any future interruption or breach of our systems.
−Removed: If our IT systems are damaged or cease to function properly, the networks or service providers we rely upon fail to function properly, or we or one of our third-party providers suffer a loss or disclosure of our business or stakeholder information due to any number of causes ranging from catastrophic events or power outages to improper data handling or security breaches and our business continuity plans do not effectively address these failures on a timely basis, we may be exposed to reputational, competitive and business harm as well as litigation and regulatory action.
−Removed: In addition, the COVID-19 pandemic may increase the risk of such vulnerability and attacks, including unauthorized access or attacks exploiting the fact that a large number of employees are working remotely.
−Removed: Furthermore, there has also been an increase in cyber incidents that appears to be associated with the Ukraine-Russia military conflict.
+Added: We maintain cybersecurity liability insurance with terms, conditions, and limits believed to be adequate.
+Added: However, cybersecurity-related liability or other claims may exceed insurance coverage limits, fines, penalties and regulatory sanctions may not be covered by insurance, or insurance may not continue to be available or available on commercially reasonable terms.
+Added: Additionally, our insurers might deny claim coverage for valid or other reasons or may become insolvent.
+Added: If our IT systems are damaged or cease to function properly, the networks or service providers we rely upon fail to function properly, or we or one of our third-party providers suffer a loss or disclosure of our business or stakeholder information due to any number of causes ranging from catastrophic events or power outages to improper data handling or security breaches or other cyber incidents, and our business continuity plans do not effectively address these failures on a timely basis, we may be exposed to reputational, competitive and business harm as well as litigation and regulatory action.
+Added: In the past, our Customers and resellers of our products have experienced cybersecurity attacks and incidents that have impacted their ability to do business, process payments and sell products, and there can be no assurance that future cybersecurity attacks and incidents affecting our Customers and resellers will not impact our business if and when they occur.
+Added: In addition, a large number of our employees, as well as those of our Customers and suppliers, continue to work remotely, which may increase the risk of IT systems vulnerabilities and attacks and unauthorized access of information.
+Added: Furthermore, there has also been an increase in cybersecurity incidents that appears to be associated with the Ukraine-Russia military conflict.
+Added: Other future or ongoing conflicts could also result in increases in cybersecurity incidents.
Enforcement of the General Data Protection Regulation (“GDPR”) was effective as of May 2018.
The GDPR is focused on the protection of personal data not merely the privacy of personal data.
−Removed: The GDPR creates a range of new compliance obligations and will significantly increase financial penalties for noncompliance (including possible fines of up to 4% of global annual revenues for the preceding financial year or €20 million (whichever is higher) for the most serious infringements).
−Removed: Net sales and profitability of our Dental segment are highly dependent on our relationships with a limited number of large distributors.
−Removed: The distribution network in the U.S.
−Removed: dental industry is concentrated, with relatively few distributors of consumable products accounting for a significant share of the sales volume to dentists.
−Removed: Historically, the top three Customers of Cantel's Dental segment accounted for more than 40.0% of its revenues.
−Removed: The loss of a significant amount of business from any of these Customers would have a material adverse effect on our Dental segment.
−Removed: In addition, because our Dental segment products are primarily sold through third-party distributors and not directly to end users, we cannot control the amount and timing of resources that our distributors devote to our products.
−Removed: There can be no assurance that there will not be a loss or reduction in business from one or more of our major Customers.
−Removed: In addition, we cannot assure that revenues from Customers that have accounted for significant revenues in the past, either individually or as a group, will reach or exceed historical levels in any future period.
+Added: The GDPR has created a range of compliance obligations and can impose significant financial penalties for noncompliance (including possible fines of up to 4% of global annual revenues for the preceding financial year or €20 million (whichever is higher) for the most serious infringements).
+Added: Other legislative or governmental regulatory requirements may come into effect that may similarly increase our compliance obligations or significantly increase our exposure to financial penalties for noncompliance.
RISKS RELATED TO BUSINESS DEVELOPMENT
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Our growth may be adversely affected if we are unable to successfully identify, price, and integrate strategic business candidates or otherwise optimize our business portfolio.
−Removed: Our success depends, in part, on strategic acquisitions and joint ventures, which are intended to complement or expand our businesses, divestiture of non-strategic businesses and other assets, and other actions intended to optimize our portfolio of businesses.
+Added: Our success depends, in part, on strategic acquisitions and joint ventures, which are intended to complement or expand our businesses, divestiture of non-strategic businesses, such as our planned divestment of the Dental segment, and other assets, and other actions intended to optimize our portfolio of businesses.
This strategy depends upon our ability to identify, appropriately price, and complete these types of business development transactions or arrangements and to obtain any necessary financing.
−Removed: In the last several fiscal years we have made a number of acquisitions and dispositions.
−Removed: There can be no assurance that any acquisition or disposition will ultimately prove to
−Removed: be a strategic success.
+Added: the last several fiscal years we have made a number of acquisitions and dispositions.
+Added: There can be no assurance that any acquisition or disposition will ultimately prove to be a strategic success.
Also, we may be unable to find or consummate future acquisitions and divestitures at acceptable prices and terms.
5 unchanged sentences
delays in realizing or failure to realize anticipated benefits of the transactions;
+Added: a termination or delay in the consummation of acquisition or disposition transactions by counterparties;
diversion of management’s time and attention from other business concerns;
difficulties in retaining key employees, Customers, or suppliers of the acquired or divested businesses;
−Removed: difficulties in maintaining uniform standards, controls, procedures and policies, or other integration or divestiture difficulties;
+Added: difficulties in maintaining uniform standards, controls, procedures and policies, or other integration or divestiture difficulties, including those that may expose us to greater cybersecurity risk;
adverse effects on existing business relationships with suppliers or Customers;
1 unchanged sentence
risks associated with the assumption of contingent or other liabilities of acquisition targets or retention of liabilities for divested businesses and difficulties in obtaining financing.
+Added: Our business realignment initiatives may not be as successful as anticipated.
+Added: We execute organizational realignments to support our growth and cost management strategies.
+Added: We also engage in initiatives aimed to increase productivity, efficiencies and cash flow and to reduce costs.
+Added: We commit significant resources to identify, develop and retain key employees to maintain uninterrupted leadership and direction.
+Added: If we are unable to successfully manage these and other organizational changes, the ability to complete such activities and realize anticipated synergies or cost savings as well as our results of operations and financial condition could be materially adversely affected.
+Added: We cannot offer assurances that any of these initiatives will be beneficial to the extent anticipated, or that the estimated efficiency improvements, incremental cost savings or cash flow improvements will be realized as anticipated or at all.
Our acquisition activity and ability to grow organically may be adversely affected if we are unable to continue to access the financial markets .
−Removed: Our recent acquisitions have been financed largely through cash on hand, borrowings under our bank credit facilities and through public note offerings.
+Added: We have financed acquisitions through cash on hand, borrowings under our bank credit facilities and through public note offerings.
Future acquisitions or other capital requirements and investments will necessitate additional cash.
−Removed: To the extent our existing sources of cash are insufficient to fund these or other future activities, we have and may need to raise additional funds through new or expanded borrowing arrangements or equity.
+Added: To the extent our existing sources of cash are insufficient to fund these or other future activities, we have and may need to raise additional funds through new or expanded borrowing arrangements or equity issuances.
There can be no assurance that we will be able to obtain additional funds beyond those available under existing bank credit facilities on terms favorable to us, or at all, or that such facilities can be replaced when they terminate.
The integration of acquired businesses into STERIS may not be as successful as anticipated.
−Removed: In recent years we have made several large acquisitions of business, including the acquisitions of Cantel Medical and Key Surgical.
+Added: We have made large acquisitions of businesses, including the acquisitions of Cantel Medical and Key Surgical.
The integration of acquired businesses into STERIS involves numerous operational, strategic, financial, accounting, legal, tax and other risks;
12 unchanged sentences
• performance shortfalls as a result of the diversion of management’s attention caused by integration activities;
−Removed: • the disruption of, or the loss of momentum in, an acquired business and STERIS’ ongoing business or inconsistencies in standards, controls, procedures and policies.
+Added: • the disruption of, or the loss of momentum in, an acquired business and STERIS’s ongoing business or inconsistencies in standards, controls, procedures and policies.
Past and future business acquisitions may not be as accretive to STERIS’s earnings per share and cash flow from operations per share, which may negatively affect the market price of STERIS shares.
5 unchanged sentences
We funded the cash portion of the Cantel Medical acquisition consideration, as well as the refinancing, prepayment, replacement, redemption, repurchase, settlement upon conversion, discharge or defeasance of certain existing indebtedness of Cantel and its subsidiaries, transaction expenses, general corporate expenses and working capital needs, through the incurrence of approximately $2.1 billion of new indebtedness, which includes $1.350 billion of senior notes issued April 1, 2021 and a new delayed draw term loan agreement in the amount of $750 million.
−Removed: We also refinanced or settled approximately $1.0 billion of Cantel's long-term indebtedness, including convertible debt, outstanding.
+Added: We also refinanced or settled approximately $1.0 billion of Cantel’s long-term indebtedness, including convertible debt.
As of March 31, 2024, STERIS had approximately $3.2 billion of indebtedness outstanding.
STERIS’s ability to repay all the forgoing obligations will depend on, among other things, STERIS’s financial position and performance, as well as prevailing market conditions and other factors beyond our control.
−Removed: Our increased indebtedness could have important consequences to our shareholders, including increasing STERIS’s interest obligations, general adverse economic and industry conditions, limiting our ability to obtain additional financing to fund future working capital, capital expenditures and other general corporate requirements, requiring the use of a substantial portion of our cash flow from operations for the payment of principal and interest on indebtedness, thereby reducing our ability to use our cash flow to fund working capital, acquisitions, capital expenditures and general corporate matters, including dividend payments and stock repurchases, limiting our flexibility in planning for, or reacting to, changes in its business and our industry and creating a disadvantage compared to our competitors with less indebtedness.
+Added: Our increased indebtedness could have important consequences to our shareholders, including increasing STERIS’s interest obligations, general adverse economic and industry conditions, limiting our ability to obtain additional financing to fund future working capital, capital expenditures and other general corporate requirements, requiring the use of a substantial portion of our cash flow from operations for the payment of principal and interest on indebtedness, thereby reducing our ability to use our cash flow to fund working capital, acquisitions, capital expenditures and general corporate matters, including dividend payments and stock repurchases, limiting our flexibility in planning for, or reacting to, changes in our business and our industry and creating a disadvantage compared to our competitors with less indebtedness.
STERIS has incurred and expects to incur significant transaction and related costs in connection with business acquisitions and dispositions, which may be in excess of those anticipated.
−Removed: STERIS has incurred substantial expenses in connection with the negotiation and completion of past business acquisitions and dispositions, including Cantel Medical and Key Surgical, and expects to incur similar costs for any future business acquisitions or dispositions.
+Added: STERIS has incurred substantial expenses in connection with the negotiation and completion of past business acquisitions and dispositions, including Cantel Medical, Key Surgical and the planned divestment of the Dental segment, and expects to incur similar costs for any future business acquisitions or dispositions.
STERIS expects to incur non-recurring costs associated with the integrations of recent acquisitions into STERIS and working towards achieving the desired synergies of such acquisitions.
11 unchanged sentences
There could be potential unknown liabilities and unforeseen expenses associated with acquisitions that were not discovered while performing due diligence.
−Removed: Although we conduct what we believe to be a prudent level of investigation regarding the operating and financial condition of the businesses, product or
−Removed: service lines, assets or technologies we purchase, an unavoidable level of risk remains regarding their actual operating and financial condition, as well as their strategic fit.
+Added: Although we conduct what we believe to be a prudent level of investigation regarding the operating and financial condition of the businesses, product or service lines, assets or technologies we purchase, an unavoidable level of risk remains regarding their actual operating and financial condition, as well as their strategic fit.
We may not be able to ascertain actual value or understand potential liabilities until or after we actually assume operation control of these businesses, product or service lines, assets or technologies.
−Removed: We have recorded goodwill and other intangible assets that could become impaired and result in material non-cash changes to our results of operation in the future.
+Added: We have recorded goodwill and other intangible assets that could become impaired and result in material non-cash charges to our results of operation in the future.
Our total assets include goodwill, intangibles and other long-lived assets.
5 unchanged sentences
Our operating results may be significantly impacted from both the impairment and the underlying trends in the business that triggered the impairment.
−Removed: During the second quarter of fiscal 2023, in connection with the preparation of our quarterly consolidated financial statements, we identified and recognized a goodwill impairment loss of $490.6 million related to goodwill that arose with respect to Dental segment acquired in the Cantel acquisition.
−Removed: UNRESOLVED STAFF COMMENTS
+Added: During the second quarter of fiscal 2023, in connection with the preparation of our quarterly consolidated financial statements, we identified and recognized a goodwill impairment loss of $490.6 million related to goodwill that arose with respect to the Dental segment acquired in the Cantel acquisition.
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.