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The risks below are not the only ones we face.
−Removed: If any of the risks actually occur, our business, financial
−Removed: condition and results of operations could be negatively affected, the trading price of our common stock could decline, and you may lose all or part of your investment.
+Added: If any of the risks actually occur, our business, financial condition and results of operations could be negatively affected, the trading price of our common stock could decline, and you may lose all or part of your investment.
Summary of Risk Factors
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• Failure of our new products, or changes to our existing products, to attract or retain consumers or generate revenue
−Removed: • Our ability to successfully integrate our acquisitions
+Added: • Successful integration of our acquisitions
Operational Risks
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• Government investigations, enforcement actions, and settlements
−Removed: • Our ability to comply with laws and regulatory and legislative mandates or guidance
+Added: • Compliance with laws and regulatory and legislative mandates or guidance
• Privacy, cybersecurity and data protection
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Intellectual Property Risks
−Removed: • Our ability to obtain, maintain, protect, and enforce our intellectual property rights
+Added: • Obtain, maintain, protect, and enforcement of our intellectual property rights
Financial, Tax and Accounting Risks
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The increase in the cost of fuel and energy, food and other essential items along with higher interest rates could reduce consumers' disposable income, resulting in decreased discretionary spending for products like ours.
+Added: Further, we cannot predict the impact of efforts by central banks and federal, state and local governments to combat higher inflation.
+Added: If their efforts are too aggressive, they may lead to a recession.
+Added: Alternatively, if they are insufficient or are not sustained long enough to lower inflation to acceptable levels, consumer spending may be adversely impacted for a prolonged period of time.
Decreases in disposable income and discretionary spending or changes in consumer confidence and spending habits has and may continue to adversely affect our revenues and operating results.
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Higher inflation has also increased domestic and international shipping costs, raw material prices, and labor rates, which has adversely impacted the costs of producing, procuring and shipping our products.
−Removed: Our ability to recover these cost
−Removed: increases through price increases may continue to lag, resulting in downward pressure on our operating results.
+Added: Our ability to recover these cost increases through price increases may continue to lag, resulting in downward pressure on our operating results.
Attempts to offset cost increases with price increases may reduce sales, increase customer dissatisfaction or otherwise harm our reputation.
−Removed: Further, we cannot predict the impact of efforts by central banks and federal, state and local governments to combat higher inflation.
−Removed: If their efforts are too aggressive, they may lead to a recession.
−Removed: Alternatively, if they are insufficient or are not sustained long enough to lower inflation to acceptable levels, consumer spending may be adversely impacted for a prolonged period of time.
−Removed: Additionally, the responses by regulators to recent bank failures could cause or continue to cause volatility in the credit or capital markets, market-wide liquidity issues, bank-runs and general concern across the global financial industry that may adversely impact consumer spending.
−Removed: While we have not been materially impacted by any of the recent bank failures, these conditions may also limit access to capital for us and our vendors and customers, making it difficult to accurately forecast and plan future business activities.
Any of these events could materially affect our business and operating results.
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Political events, trade and other international disputes, war, and terrorism could harm or disrupt international commerce and the global economy and could have a material effect on our business as well as our customers, suppliers, contract manufacturers, distributors, and other business partners.
−Removed: Such risks include inflation, supply chain and trade disruptions, trade sanctions, reduced consumer spending, disruptions to our IT systems, including through network failures, malicious or disruptive software, or cyberattacks, energy shortages or rationing that adversely impacts our manufacturing facilities, rising fuel or rising costs of producing, procuring and shipping our products, fluctuations to foreign currency exchange rates, and constraints, volatility or disruption in the financial markets.
+Added: Such risks include inflation, supply chain and trade disruptions, trade sanctions, reduced consumer spending, disruptions to our IT systems, including through network failures, malicious or
+Added: disruptive software, or cyberattacks, energy shortages or rationing that adversely impacts our manufacturing facilities, rising fuel or rising costs of producing, procuring and shipping our products, fluctuations to foreign currency exchange rates, and constraints, volatility or disruption in the financial markets.
Political events, trade and other international disputes, wars, and terrorism can lead to unexpected tariffs or trade restrictions, which may adversely impact our business.
−Removed: Tariffs increase the cost of our products and the components and raw materials used to make them.
+Added: Tariffs, such as the tariffs on Chinese goods, and responses to the tariffs increase the cost of our products and the components and raw materials used to make them.
Increased costs could adversely impact our gross margin and reduce demand for our products.
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For example, our employees in Israel could be obligated to perform reserve duty in the Israeli military and be called for additional active duty under emergency circumstances .
−Removed: If any of these events or conditions occur, the impact to us, our employees and customers is uncertain, particularly if emergency circumstances, armed conflicts or an escalation in political instability or violence disrupts our product development, data or information exchange, payroll or banking operations, product or materials shipping by us or our suppliers and other unanticipated business disruptions, interruptions and limitations in telecommunication services or critical systems or applications reliant on a stable and uninterrupted communications infrastructure.
+Added: If this or any other events or conditions occur, the impact to us, our employees and customers would be uncertain, particularly if emergency circumstances, armed conflicts or an escalation in political instability or violence disrupts our product development, data or information exchange, payroll or banking operations, product or materials shipping by us or our suppliers and other unanticipated business disruptions, interruptions and limitations in telecommunication services or critical systems or applications reliant on a stable and uninterrupted communications infrastructure.
The military conflict between Russia and Ukraine has materially adversely impacted global economies.
Our commercial operations have been impacted by the conflict and if we fail to support existing customers, we may harm our reputation, and be subject to legal and regulatory actions in Russia.
−Removed: Additionally, although the majority of our research and development personnel
−Removed: formerly headquartered in Russia have relocated, some personnel remain.
+Added: Additionally, although the majority of our research and development personnel formerly headquartered in Russia have relocated, some personnel remain.
Whether those that are in Russia or those in their new locations remain with us over the long-term is unknown.
If we are unable to retain key skilled personnel, or we are unable to quickly replace such personnel with individuals of equivalent technical expertise and qualifications, our business and financial condition could be materially effected.
−Removed: Moreover, production could be impaired as a result of the military conflict in other countries such as Poland, where one of our aligner fabrication facilities is located.
+Added: Moreover, production could be impaired as a result of the military conflict in other countries such as Poland and Israel, where our fabrication facilities are located.
We have no way to predict the progress or outcome of the conflict in Ukraine or the reactions by governments, businesses or consumers but it could have a material effect on our business and operating results.
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Our locations in Costa Rica and Mexico as well as others are in earthquake and hurricane zones and may be subject to other natural disasters.
−Removed: Moreover, a significant portion of our research and development activities are located in California, which suffers from earthquakes, periodic droughts, heat waves, flooding, power shortages and wildfires.
+Added: Moreover, a significant
+Added: portion of our research and development activities are located in California, which suffers from earthquakes, periodic droughts, heat waves, flooding, power shortages and wildfires.
If a natural disaster occurs in a region where one of these facilities is located, our employees could be impacted, our research lost, and our ability to create treatment plans, respond to customer inquiries or manufacture and ship our aligners or intraoral scanners could be compromised which could result in our customers experiencing significant product and services delays.
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Demand for our products may not increase or may decrease due to resistance to non-traditional treatment methods, which could have a material impact on our business and operating results.
−Removed: Invisalign treatment is a significant change from traditional metal wires and brackets orthodontic treatment, and customers and consumers may not find it cost-effective or preferable to traditional treatment.
−Removed: For instance, a number of dental professionals continue to believe Invisalign treatment is only appropriate for a limited percentage of patients or are reluctant to move from analog to digital.
+Added: Our products require our customers to change from traditional treatment methods.
+Added: For example, Invisalign treatment is a significant change from traditional metal wires and brackets orthodontic treatment, and customers and consumers may not find it cost-effective or preferable to traditional treatment.
+Added: A number of dental professionals continue to believe Invisalign treatment is only appropriate for a limited percentage of patients or are reluctant to move from analog to digital.
+Added: Additionally, our iTero products provide a digital alternative and some dental professionals have been and may continue to be resistant to move to a digital platform.
Increased market acceptance of our products depends in part on the recommendations of dental professionals, as well as other factors including efficacy, safety, ease of use, reliability, aesthetics, and price compared to competing products and treatment methods.
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Our iTero business also contributes a material percentage of our overall net revenues.
−Removed: Our CAD/CAM software solutions are important to the continuing evolution of our Align Digital Platform and our business overall.
Our operating results could be harmed if:
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While solutions such as our Invisalign system, iTero scanners and CAD/CAM software facilitate this transition, whether our technologies will achieve market acceptance and, if adopted, whether and when they may become obsolete, remains unclear.
−Removed: Currently, the Invisalign system competes primarily against traditional metal wires and brackets and increasingly against clear aligners manufactured and distributed by new market entrants and manufacturers of traditional wires and brackets, and from traditional medical device companies, laboratories, startups and, in some cases, doctors and Dental Support Organizations ("DSOs") themselves.
+Added: In addition, we face competition from companies that introduce new technologies and products and we may be unable to compete with these competitors or they may render our technology or products obsolete or economically unattractive.
+Added: If we are unable to compete effectively with existing products or respond effectively to any new technologies, our business could be harmed.
+Added: Currently, the Invisalign system competes primarily against traditional metal wires and brackets and increasingly against clear aligners manufactured and distributed by new and existing market entrants and manufacturers of traditional wires and brackets, and from traditional medical device companies, laboratories, startups and, in some cases, doctors and Dental Support Organizations (“DSOs”) themselves.
The number and types of competitors are diverse and growing rapidly.
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Doctors and DSOs are sampling alternative products and taking advantage of competitive promotions and sale opportunities.
−Removed: In addition, we face competition from companies that introduce new technologies and we may be unable
−Removed: to compete with these competitors or they may render our technology obsolete or economically unattractive.
−Removed: If we are unable to compete effectively with existing products or respond effectively to any new technologies, our business could be harmed.
Our iTero intraoral scanner can be used to start clear aligner therapy, as well as other dental procedures, including restorative, implant planning and dentures, and also functions as a diagnostic tool.
−Removed: The iTero intraoral scanner competes with polyvinyl siloxane (“PVS”) impressions that doctors use for clear aligner therapy or other dental procedures, as well as other intraoral scanners.
+Added: The iTero intraoral scanner competes with polyvinyl siloxane (“PVS”) impressions and new scanners in the market that doctors use for clear aligner therapy or other dental procedures.
It also competes with traditional bite wing 2D dental x-rays for detecting interproximal caries.
If we are unable to compete effectively with these existing products, existing competitors, new market entrants, or respond effectively to new technologies, our Systems and Services segment could be harmed.
−Removed: To stimulate product and services demand, we have a history of offering volume discounts, price reductions and other promotions to targeted customers and consumers.
−Removed: Whether or not successful, these promotional campaigns have had and may in the future have unexpected and unintended consequences, including reduced gross margins, profitability and average selling prices, net revenues, volume growth, and net income.
+Added: To stimulate product and services demand, we have a history of offering volume discounts, price reductions and other promotions to targeted customers and consumers and releasing lower priced products.
+Added: Whether or not successful, these promotional campaigns and lower priced products have had and may in the future have unexpected and unintended consequences, including reduced gross margins, profitability and average selling prices, net revenues, volume growth, and net income.
We cannot be sure that we will be able to compete successfully against our current or future competitors or that competitive pressures will not have a material effect on our business, results of operations and financial condition.
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• qualify for third-party reimbursement for procedures involving our products or services;
+Added: • offer attractive and competitive service and subscription plans;
• encourage customers to adopt new technologies and provide the needed technical, sales and marketing support to make new product and services launches successful .
−Removed: If we fail to accurately predict the needs and preferences of customers and their patients, or fail to produce viable technologies, we may invest heavily in research and development that does not lead to significant revenues.
+Added: If we fail to accurately predict the needs and preferences of customers and their patients, or fail to produce viable technologies or products, we may invest heavily in research and development that does not lead to significant revenues.
Even if we successfully innovate and develop new products and product improvements, we may incur substantial costs doing so and our profitability may suffer.
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Conversely, if we overestimate customer demand, we may lose opportunities to increase revenues and profits, we may have excessive staffing, materials, components and finished products, or capacity.
−Removed: If we hire and train too many technicians in anticipation of demand that does not materialize or materializes slower than anticipated, our costs and expenditures may outpace our revenues or revenue growth, harming our gross margin and financial results.
+Added: If we hire and train too many technicians in anticipation of demand that does not materialize or materializes slower than anticipated, our costs and expenditures may
+Added: outpace our revenues or revenue growth, harming our gross margin and financial results.
Additionally, to secure supplies for production of products, we periodically enter into non-cancelable minimum purchase commitments with vendors, which could impact our ability to adjust inventory for declining demand.
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We are subject to operating risks, including excess or constrained capacity and pressure on our internal systems, personnel and suppliers.
−Removed: To manage current and anticipated future operations effectively, we must continually implement and improve our operational, financial and management information systems, hire, train, motivate, manage and retain employees, and ensure our
−Removed: suppliers remain diverse and capable of meeting demand for the systems, raw materials, parts and components essential to the manufacture and delivery of our products.
+Added: To manage current and anticipated future operations effectively, we must continually implement and improve our operational, financial and management information systems, hire, train, motivate, manage and retain employees, and ensure our suppliers remain diverse and capable of meeting demand for the systems, raw materials, parts and components essential to the manufacture and delivery of our products.
We may be unable to balance near-term efforts to meet existing demand with future demand, including adding personnel, creating scalable, secure and robust systems and operations, and automating processes needed for long term efficiencies.
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Additionally, we have established treatment planning and manufacturing facilities closer to our international customers to provide them with better experiences, improve their confidence using our products to treat patients, create efficiencies, and provide redundancy should other facilities be temporarily or permanently unavailable.
−Removed: Our ability to obtain and maintain regulatory clearance and certifications and equip facilities is subject to significant risk and uncertainty.
+Added: Our ability to equip facilities is subject to significant risk and uncertainty.
If a facility is temporarily or permanently, partially or fully shut down, or if demand for our products outpaces our ability to hire qualified personnel and effectively implement systems and infrastructure, we may be unable to fulfill orders timely, or at all, which may negatively impact our financial results, reputation and overall business.
−Removed: Our products and information technology systems are critical to our business.
+Added: Our products and IT systems are critical to our business.
Issues with product development or enhancements, IT system and software integration, implementation, updates and upgrades have previously and could again in the future disrupt our operations and have a material impact on our business, our reputation and operating results.
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A significant portion of our clear aligner production is dependent on digital scans from our globally dispersed and decentralized installed base of iTero and third-party intraoral scanners.
−Removed: Failures of all or any portion of ours or third-party software or other components or systems to interoperate with iTero or third-party scanners, termination of interoperability with third-party scanners, malware or ransomware attacks, product or system vulnerabilities or defects, interference or disruptions for us, our customers, labs or other business partners in the use of our products or the transmission or processing of data needed
−Removed: for the use or ordering of our products, or a system outage for any reason have harmed our operations previously and in the future could affect materially and adversely our ability to accept scans, manufacture clear aligners or restorative procedures or treatments and services or otherwise service our customers which may, amongst other things, harm our sales, damage our reputation, adversely impact our strategic partners or result in litigation.
+Added: Failures of all or any portion of ours or third-party software or other components or systems to interoperate with iTero or third-party scanners, termination of interoperability with third-party scanners, malware or ransomware attacks, product or system vulnerabilities or defects, interference or disruptions for us, our customers, labs or other business partners in the use of our products or the transmission or processing of data needed for the use or ordering of our products, or a system outage for any reason have harmed our operations previously and in the future could affect materially and adversely our ability to accept scans, manufacture clear aligners or restorative procedures or treatments and services or otherwise service our customers which may, amongst other things, harm our sales, damage our reputation, adversely impact our strategic partners or result in litigation.
We are highly dependent on third-party suppliers, some of whom are sole source suppliers, for certain key machines, components and materials, and our business and operating results could be harmed if supply is restricted or ends, or if the price of raw materials used in our manufacturing process increases.
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We strive to retain our personnel by providing competitive compensation and benefits, development opportunities and training, flexible work options, and an inclusive corporate culture.
−Removed: However, there is substantial competition in our industry for highly-skilled personnel, in particular significantly higher demand for technical and digital talent.
−Removed: Furthermore, our compensation and benefit arrangements, such as our equity award programs, may not successfully attract new employees and retain and motivate existing employees.
+Added: However, there is substantial competition in our industry for highly-skilled personnel, in particular significantly higher demand for technical and digital talent, and our competitors have in the past and will likely continue in the future to recruit our personnel.
+Added: Our compensation and benefit arrangements, such as our equity award programs, may not successfully attract new employees and retain and motivate existing employees.
In addition, other internal and external factors can impact our ability to hire and retain talent, including insufficient advancement or career opportunities and restrictive immigration policies .
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however, there is no assurance they will achieve the returns on advertising spend desired, increase brand or product awareness sufficiently or generate goodwill and positive reputational goals.
−Removed: Moreover, should any entity or individual endorsing us or our products take actions, make or publish statements in support of, or lend support to events or causes which may be perceived by a portion of
−Removed: society negatively, our sponsorships or support of these entities or individuals may be questioned, our products boycotted, and our reputation harmed, any of which could have a material effect on our financial results and business overall.
+Added: Moreover, should any entity or individual endorsing us or our products take actions, make or publish statements in support of, or lend support to events or causes which may be perceived by a portion of society negatively, our sponsorships or support of these entities or individuals may be questioned, our products boycotted, and our reputation harmed, any of which could have a material effect on our financial results and business overall.
In addition, various countries prohibit certain types of marketing activities.
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Governments and regulators are actively developing new competition laws and regulations aimed at the technology sector, artificial intelligence and digital platforms and coordinating their activities globally, including in large markets such as the EU, U.S., and China.
−Removed: Government regulatory actions and court decisions may result in fines or hinder our ability to provide certain benefits to our consumers, reducing the attractiveness of our products and the revenue derived from them.
+Added: Government regulatory actions and court decisions may result in fines or hinder our ability to provide certain benefits to our consumers, reducing the attractiveness of our products and the revenue derived from them or our ability to pursue certain mergers, acquisitions, business combinations or other transactions.
Other companies and government agencies have in the past and may in the future allege that our actions violate antitrust or competition laws or otherwise constitute unfair competition.
−Removed: Such claims and investigations, even if unfounded, may be expensive to defend, involve negative publicity, and divert management time and attention, any of which may materially impact our results of operations.
+Added: Such claims and investigations, even if unfounded, may be
+Added: expensive to defend, involve negative publicity, and divert management time and attention, any of which may materially impact our results of operations.
Obtaining approvals and complying with governmental regulations, particularly those related to personal healthcare and financial information, quality systems, anti-corruption and anti-bribery are expensive and time-consuming.
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Additionally, a large portion of our revenues are derived from international sales and we are dependent on our international operations, which exposes us to additional foreign regulations not otherwise described in these risk factors.
−Removed: There can be no assurance we can adequately address the business risks associated with the
−Removed: implementation and compliance with such laws and our internal processes and procedures to comply with such laws or that we will be able to take advantage of any resulting business opportunities.
+Added: There can be no assurance we can adequately address the business risks associated with the implementation and compliance with such laws and our internal processes and procedures to comply with such laws or that we will be able to take advantage of any resulting business opportunities.
Furthermore, before we can sell a new medical device or market a new use of or claim for an existing product, we must frequently obtain clearance or approval to do so.
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In addition, patient care could suffer, and we could be liable if our products or IT systems fail to timely deliver accurate and complete information.
−Removed: We have internal monitoring and detection systems as well as
−Removed: cybersecurity and other forms of insurance coverage related to a breach event.
+Added: We have internal monitoring and detection systems as well as cybersecurity and other forms of insurance coverage related to a breach event.
However, damages and claims arising from such incidents may not be covered or may exceed the amount of any coverage and do not cover the time and effort we incur investigating and responding to any incidents, which may be material.
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Our business exposes us to potential liability for the quality and safety of our products and services, how we advertise and market those products and services and how and to whom we sell them, and we may incur substantial expenses or be found liable for substantial damages or penalties if we are subject to claims or litigation.
−Removed: Our products and services involve an inherent risk of claims concerning their design, materials, manufacture, safety and performance, how they are marketed and advertised in a complex framework of highly regulated domestic and international laws and regulations, how we package, bundle or sell them to individual customers or companies, including hospitals and clinics, and how we train and support doctors, their staffs and patients who use our products.
+Added: Our products and services involve an inherent risk of claims concerning their design, materials, manufacture, safety and performance, how they are marketed and advertised in a complex framework of highly regulated domestic and international
+Added: laws and regulations, how we package, bundle or sell them to individual customers or companies, including hospitals and clinics, and how we train and support doctors, their staffs and patients who use our products.
Moreover, consumer products and services are routinely subject to claims of false, deceptive or misleading advertising, consumer fraud and unfair business practices.
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Our compliance obligations will likely span all aspects of our business and operations, including product design and development, materials sourcing and other procurement activities, product packaging, product safety, energy and natural resources usage, facilities design and utilization, recycling and collection, transportation, disposal activities and workers’ rights.
−Removed: Environmental regulations related to greenhouse gases are expected to have an increasingly larger impact on our or our suppliers’ energy sources.
+Added: Environmental regulations related to greenhouse gases, sustainability and reduction of waste are expected to have an increasingly larger impact on us or our suppliers.
and foreign regulators have or are considering enacting new or additional disclosure requirements or limits on the emissions of greenhouse gases, including carbon dioxide and methane, from power generation units using fossil fuels.
The effects of greenhouse gas emission limits on power generation are subject to significant uncertainties, including the timing of any new requirements, levels of emissions reductions and the scope and types of emissions regulated.
−Removed: These limits may increase our costs and those of our suppliers and could result in manufacturing, transportation and supply chain disruptions if clean energy alternatives are not readily available in adequate amounts when
+Added: Additionally, laws on sustainability and waste reduction are emerging and consumers may demand more sustainability in our products.
+Added: Such regulations and consumer demands may affect how we manufacture and package our products, which may increase our costs and those of our suppliers and could result in manufacturing, transportation and supply chain disruptions if clean energy or sustainable alternatives are not readily available in adequate amounts when required.
Moreover, alternative energy sources, coupled with reduced investments in traditional energy production and infrastructure, may not provide predictable, reliable, and consistent energy that we, our suppliers and other businesses require.
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Additionally, public interest and legislative pressure related to companies’ ESG practices continues to grow.
−Removed: If our ESG practices fail to meet investor or other industry stakeholders' evolving and frequently evolving expectations and standards, including environmental stewardship, support for local communities, board of director and employee diversity, human capital management, employee health and safety practices, product quality, supply chain management, corporate governance and transparency and employing ESG strategies in our operations, our brand, reputation and employee retention may be harmed, customers and suppliers may be unwilling to do business with us and investors may be unwilling to invest in us.
+Added: If our ESG practices fail to meet investor or other industry stakeholders’ frequently evolving expectations and standards, including environmental stewardship, support for local communities, board of director and employee diversity, human capital management, employee health and safety practices, product quality, supply chain management, corporate governance and transparency and employing ESG strategies in our operations, our brand, reputation and employee retention may be harmed, customers and suppliers may be unwilling to do business with us and investors may be unwilling to invest in us.
We also expect to incur additional costs and require additional resources to monitor, report, and comply with our various ESG practices.
−Removed: If we fail to adopt ESG standards or practices as quickly as stakeholders desire, report on our ESG efforts or practices accurately, or satisfy the disclosure and other expectations of stakeholders, our reputation, business, financial performance, growth, and stock price may be adversely impacted.
+Added: If we fail to adopt ESG standards or practices as quickly as stakeholders
+Added: desire, report on our ESG efforts or practices accurately, or satisfy the disclosure and other expectations of stakeholders, our reputation, business, financial performance, growth, and stock price may be adversely impacted.
Intellectual Property Risks
Our success depends in part on our proprietary technology, and if we fail to successfully obtain or enforce our IP rights, our competitive position may be harmed.
−Removed: Our success depends in part on our ability to maintain existing IP rights and obtain and maintain further IP protection for our products.
+Added: Our success depends in part on our ability to maintain existing IP rights and obtain, maintain and enforce further IP protection for our products.
Our inability to do so could harm our competitive position.
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If these agreements do not provide meaningful protection against the unauthorized use or disclosure of our trade secrets or other confidential information, adequate remedies may not exist to prevent unauthorized uses or disclosures.
−Removed: Our inability to maintain the proprietary nature of our technology through patents, copyrights or trade secrets would impair our competitive advantages and could have a material effect on our operating results, financial condition and future
−Removed: growth prospects.
+Added: Enforcement of our IP rights is time-consuming and costly, and could ultimately prove to be unsuccessful.
+Added: In certain jurisdictions, enforcement of IP rights is more difficult due to legislation and geopolitical circumstances.
+Added: As we launch our products in different regions at different times, our products may be acquired and reverse engineered by potential competitors in regions where infringement is more difficult to pursue.
+Added: Our inability to maintain the proprietary nature of our technology through patents, copyrights or trade secrets would impair our competitive advantages and could have a material effect on our operating results, financial condition and future growth prospects.
In particular, a failure to protect our IP rights might allow competitors to copy our technology or create counterfeit or pirated versions of our products, which could adversely affect our reputation, pricing and market share.
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In addition, we periodically receive letters from third parties drawing our attention to their IP rights and there may be other third-party IP rights of which we are presently unaware.
+Added: As dentistry becomes more digital, competitors may make defense of our IP more challenging.
Asserting or defending these proceedings can be unpredictable, protracted, time-consuming, expensive and distracting to management and technical personnel.
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Changes in tax laws or changes to how those laws are applied to our business in practice, could affect the amount of tax to which we are subject and the manner in which we operate.
−Removed: Additionally, the Organization for Economic Cooperation and Development’s (“OECD”) Base Erosion and Profit Shifting (“BEPS”) project has resulted in considerable new reporting obligations worldwide.
−Removed: The OECD continues to publish guidance pursuant to the BEPS and other projects which, if adopted by member countries, may affect our tax positions in many of the countries in which we do business.
+Added: Additionally, the Organization for Economic Cooperation and Development’s (“OECD”) Base Erosion and Profit Shifting (“BEPS”) project proposes changes to long-standing tax principles, including allocating greater taxing rights to countries where customers are located and establishing a global minimum tax rate of at least 15%.
+Added: Numerous countries are evaluating their existing tax laws due in part to recommendations made by the OECD’s BEPS project.
+Added: The changes proposed by the BEPS project, if adopted by specific countries, may increase tax uncertainty and adversely affect our provision for income taxes.
Moreover, the application of indirect taxes (such as sales and use tax (“SUT”), value-added tax (“VAT”), goods and services tax (“GST”), and other indirect taxes) to our operations is complex and evolving.
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There is no assurance that we will continue repurchasing our common stock in the future at historical levels or at all, or that our stock repurchase programs will beneficially impact our stock price.
−Removed: Additionally, effective January 1, 2023, the IRA imposes a 1% excise tax on our stock repurchases, which will increase our tax liabilities and the cost to retire stock and may impact if and how much stock we choose to repurchase in the future.
+Added: Additionally, effective January 1, 2023, the Inflation Reduction Act imposes a 1% excise tax on our stock repurchases, which will increase our tax liabilities and the cost to retire stock and may impact if and how much stock we choose to repurchase in the future.
Future sales of significant amounts of our common stock may depress our stock price.
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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.