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Macroeconomic and External Risks
−Removed: Our business, financial condition and results of operations depend on global and regional economic conditions.
−Removed: Inflation, fluctuations in foreign currency exchange rates, changes in consumer confidence and demand, general economic weakness and actual or potential slowdowns or recessions have and could in the future materially affect our business, financial condition and results of operations.
−Removed: Macroeconomic conditions impact consumer confidence and discretionary spending, which can adversely affect demand for dental services and our products.
−Removed: Consumer spending habits are affected by, among other things, fluctuations in foreign currency exchange rates, changes in consumer confidence and demand, inflation, general economic weakness, actual or potential slowdowns or recessions, pandemics, wars and military actions, employment levels, health insurance coverage, wages, debt obligations, discretionary income, interest rates, market volatility and perceptions of current and future economic conditions.
−Removed: Macroeconomic conditions can, among other things, reduce or shift spending away from elective procedures, drive patients to pursue less costly orthodontic treatments, decrease the number of orthodontic case starts, reduce patient traffic in
−Removed: dental offices, or reduce demand for dental services generally.
−Removed: For instance, decreased demand for dental services have and may in the future cause doctors and labs to use wires and brackets more frequently for orthodontic treatment instead of clear aligners and postpone investments in capital equipment, such as intraoral scanners and CAD/CAM equipment and software.
+Added: Global and regional economic conditions have and could in the future materially affect our business, financial condition and results of operations.
+Added: Macroeconomic conditions impact consumer confidence and discretionary spending, which can reduce or shift spending away from elective procedures, drive patients to pursue less costly orthodontic treatments, decrease the number of orthodontic case starts, reduce patient traffic in dental offices, or reduce demand for dental services generally.
+Added: Consumer spending habits are affected by, among other things, fluctuations in foreign currency exchange rates, changes in consumer confidence and demand, inflation, general economic weakness, actual or potential slowdowns or recessions, employment levels, health insurance coverage, wages, debt obligations, discretionary income, interest rates, cultural and social influences, market volatility and perceptions of current and future economic conditions.
+Added: For instance, decreased demand for dental services has and may in the future cause doctors and labs to revert to wires and brackets and postpone investments in capital equipment.
Uncertain economic outlooks for, or declines in the economic outlooks of, the United States, Chinese, European and other economies have and could in the future materially adversely affect consumer demand and dental practice spending.
−Removed: Increases in the cost of fuel and energy, food, and other essential or discretionary items as well as higher interest rates have and could in the future reduce consumers’ disposable income, which could cause a decrease in discretionary spending for our products.
+Added: Higher interest rates have and could in the future reduce consumers’ disposable income, which could cause a decrease in discretionary spending for our products.
Inflation has and may continue to adversely impact spending and trade activities, and may unpredictably impact global and regional economies.
Efforts by central banks and federal, state and local governments to combat inflation could result in an economic recession or slowdown or adversely impact consumer spending for a prolonged period of time.
−Removed: Higher inflation has and may continue to increase domestic and international shipping costs, raw material prices and labor rates, which could adversely impact the costs of producing, procuring and shipping our products.
+Added: Higher inflation, as well as the cost of fuel, energy and domestic and international shipping costs, food and other essential or discretionary items, raw material prices and labor rates, has and may continue to rise, which could adversely impact the costs of producing, procuring and shipping our products.
We may not be able to fully mitigate the impact of the increased costs or pass price increases on to our customers, which could result in downward pressure on our operating results.
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Any of these events could materially affect our business, financial condition or results of operations.
+Added: We are subject to foreign currency exchange fluctuations, which could have a material adverse effect on our financial condition or results of operations.
We have significant international operations and sales and are therefore exposed to fluctuations in foreign currencies that have and may continue to adversely impact our business, financial condition or results of operations.
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Currency exchange rate fluctuations have and may continue to materially adversely affect our results of operations and cash flows.
−Removed: Our business, financial condition and results of operations could be impacted by geopolitical events, new, proposed or retaliatory tariffs, trade and international disputes, wars, military actions and terrorism, or major public health crises .
−Removed: Geopolitical events, threats or actual imposition of tariffs, customs duties and fees by nations and retaliatory actions, trade and international disputes, wars, military actions and terrorism, or major public health crises have and could in the future harm or disrupt international commerce and the global economy and could materially adversely affect our business with our customers and consumers, suppliers, contract manufacturers, commercial intermediaries and other business partners.
+Added: Geopolitical events, tariffs and trade policies, and military conflicts have and could in the future materially affect our business, financial condition and results of operations .
+Added: Geopolitical events, wars, military actions, terrorism, or major public health crises have and could in the future harm or disrupt international commerce and the global economy, and could materially adversely affect our business.
Such events have and could result in, among other things, supply chain and trade disruptions, changes in diplomatic and trade relationships, new and retaliatory tariffs, trade protection measures, quotas, embargoes, trade sanctions and countersanctions, customs investigations or restrictions, boycotts, reduced consumer spending, government shutdowns, cyberattacks, energy shortages or power outages, energy rationing that adversely impacts our manufacturing facilities, rising fuel or rising costs of producing, procuring, and shipping our products, constraints, volatility or disruption in the financial markets, employee deaths or injuries, restrictions and shortages of food, water, shelter and medical supplies, data or information exchange, disruptions, interruptions or limitations in telecommunication services, critical systems or applications reliant on a stable and uninterrupted communications infrastructure, and protests that may impact delivery of our products to customers or destruction of property.
Such events may also cause a shift in public opinion about companies based in the United States or in the regions where we operate or plan to operate, which could adversely impact our reputation and business.
−Removed: Tariffs or proposed tariffs, customs duties or fees, and any retaliatory tariffs or protectionist trade measures taken in response to such tariffs may increase the cost of our products, components or the raw materials used to make them, reduce demand for our products, limit our ability to sell to certain customers, limit or prohibit the availability of certain raw materials, components and parts necessary for our products or the products of our suppliers, or impede or slow the movement of our goods across borders.
+Added: Tariffs or proposed tariffs, customs duties, or fees, and any retaliatory tariffs, international trade disputes, or protectionist trade measures taken in response to such tariffs may increase the cost of our products and the components or the raw materials used to make them, reduce demand for our products and adversely impact our gross margin and results of operations, limit our ability to sell to certain customers, limit or prohibit the availability of certain raw materials, components and parts necessary for our products or the products of our suppliers, or impede or slow the movement of our goods across borders.
For example, the U.S.
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For example, we manufacture clear aligners in our facility in Mexico and ship them to the United States, primarily for our United States customers, with the remainder eventually shipped to other international locations.
−Removed: Tariffs have and could in the future result in additional costs for our products, which may reduce demand for our products and adversely impact our gross margin and results of operations, and we may not be able to fully or substantially mitigate the impact of any new or increased tariffs or pass price increases on to our customers.
+Added: Tariffs have and could in the future result in additional costs for our products, which may reduce demand for our products and adversely impact our gross margin and results of operations, and we may not be able to fully or substantially mitigate the impact of any new or increased tariffs or pass price increases on to our customers and to the extent we do, we may experience reduced demand for our products.
+Added: On February 20, 2026, the U.S.
+Added: Supreme Court ruled that certain of the tariffs imposed under the International Emergency Economic Powers Act were unlawful, and while we are no longer subject to such tariffs as a result of that decision, we are currently subject to new, temporary tariffs on imports under Section 122 of the Trade Act of 1974, effective February 24, 2026.
The extent and duration of any tariffs and the resulting impact on general economic conditions and on our business, financial condition and results of operations are uncertain.
−Removed: Foreign countries have and may continue to adopt or rescind other measures, such as controls on the import or export of goods, technology or data, including personal data, which could adversely impact our operations and supply chains or limit our ability to offer certain products or services.
+Added: Foreign countries have and may continue to adopt other measures such as controls on the import or export of goods, technology or data, including personal data, which could adversely impact our operations and supply chains or limit our ability to offer certain products or services.
We may take various actions in response to these measures, including changing suppliers, where we manufacture our products, or restructuring business relationships.
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Trade restrictions may be announced with little or no advance notice and we may be unable to effectively mitigate any adverse impacts in a timely manner or at all.
−Removed: Military conflicts have and may in the future materially adversely impact the economies in which we operate.
−Removed: Our iTero operations, headquartered in Israel, are close to areas that have been affected by the ongoing conflict between Israel and Hamas since October 7, 2023.
−Removed: A ceasefire was agreed upon between both sides in early October 2025.
−Removed: It is uncertain whether the ceasefire will be sustained and lead to a lasting resolution of the conflict.
−Removed: If the ceasefire is not sustained, we may be at a continued risk of damage to our properties, personnel and resources, which may impact our employees and our iTero business and operations.
−Removed: Some employees in Israel have been called for military service in the conflict and they may be absent for certain periods of time.
−Removed: Furthermore, if the conflict resumes, our facilities may be damaged or our manufacturing capability or delivery
−Removed: schedules impacted as a result of the conflict.
−Removed: Our supply chains and demand for our products could be impaired as a result of hostilities, export and import restrictions, sanctions or boycotts.
+Added: Military conflicts, wars, and escalation of terrorist or gang activities have and may in the future materially adversely impact the economies in which we operate.
+Added: Our iTero operations, headquartered in Israel, are close to areas that have been affected by the conflict between Israel and Hamas.
+Added: The outbreak of military conflict between the United States and Iran on February 28, 2026 and Israel’s war against Iran has resulted in instability around the Middle East region, particularly a disruption in shipment of global oil and gas flows, with cascading effects on energy prices and global economic conditions.
+Added: Additionally, our supply chains and demand for our products could be impaired as a result of political instability, drug trafficking, the continuation or escalation of terrorist or gang activities (particularly with respect to our manufacturing operations in Mexico), hostilities, export and import restrictions, sanctions or boycotts.
These events could disrupt ongoing operations and may materially impact the logistics, timing and cost of shipping of our products and materials or our ability to operate out of impacted areas, and our ongoing contingency planning and business continuity measures to mitigate these risks may not be sufficient.
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We cannot predict the progress or outcome of these events or the reactions by governments, businesses or consumers and each event could, individually or in the aggregate, materially adversely affect our business, financial condition and results of operations.
−Removed: Our operations may be impacted by natural disasters, which may become more frequent or severe as a result of climate change, and may adversely impact our business, financial condition and results of operations, as well as those of our customers and consumers, suppliers, contract manufacturers, commercial intermediaries and other business partners.
−Removed: Natural disasters such as earthquakes, tsunamis, floods, droughts, hurricanes, wildfires, urban fires, volcanic eruptions and other extreme weather conditions can cause deaths, injuries and major public health crises, power outages, property damage, restrictions and shortages of food, water, shelter and medical supplies, telecommunications failures, materials scarcity, price volatility and other adverse consequences.
+Added: Natural disasters may adversely impact our business, financial condition and results of operations, as well as those of our customers and consumers, suppliers, contract manufacturers, commercial intermediaries and other business partners.
+Added: Natural disasters and extreme weather conditions (including those caused by climate change) can cause deaths, injuries and major public health crises, power outages, property damage, restrictions and shortages of food, water, shelter and medical supplies, telecommunications failures, materials scarcity, price volatility and other adverse consequences.
If a natural disaster occurs in a region where one of our facilities or those of our customers or suppliers are located, our or their employees or facilities could be impacted, valuable research could be lost, and our ability to create treatment plans, respond to customer inquiries or manufacture and ship our products could be compromised, causing significant delays and reputational harm.
−Removed: Climate change could increase the frequency and severity of natural disasters and could change the supply, demand or availability of sources of energy or resources material to manufacturing our products and operations.
+Added: Climate change could increase the frequency and severity of natural disasters such as hurricanes, tornadoes, earthquakes, wildfires, droughts, extreme temperatures, or flooding which could cause supply chain interruptions, increase demand and negatively impact availability of sources of energy or resources material to manufacturing our products and operations, or cause damage to our products and facilities.
It could also affect the availability or cost of materials, goods, and services on which we and our suppliers, contract manufacturers, commercial intermediaries and other business partners rely, which could materially adversely impact our business, financial condition and results of operations.
Business and Industry Risks
−Removed: Demand for our products and services may not increase or may decrease for many reasons, including resistance to the innovative and business-model-disruptive nature of some of our products and services, which could have a material impact on our business, financial condition and results of operations.
+Added: Demand for our products and services may not increase or may decrease for many reasons, including resistance to the innovative and business-model-disruptive nature of some of our products and services.
Our products and services require our customers and consumers to forego traditional treatment methods.
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Additionally, our clear aligners and iTero products utilize digital technology and some dental professionals have and may continue to resist moving to a digital platform.
−Removed: Increased acceptance of our products and services depends in part on the recommendations of dental professionals, professional associations, societies and organizations, as well as other factors, including efficacy, safety, ease of use, reliability, aesthetics, third-party reimbursement, price compared to traditional treatment methods and competing products, and perceptions regarding single-use or non-recyclable plastics.
+Added: Increased acceptance of our products and
+Added: services depends in part on the recommendations of dental professionals, professional associations, societies and organizations, as well as other factors, including efficacy, safety, ease of use, reliability, aesthetics, third-party reimbursement, price compared to traditional treatment methods and competing products, and perceptions regarding single-use or non-recyclable plastics.
Additionally, negative experiences with clear aligner products manufactured or distributed by competitors may adversely affect our reputation and demand for the Invisalign System if consumers or dental professionals attribute these negative experiences to clear aligner therapy generally, even if our products differ significantly in design, quality, and clinical effectiveness.
If demand for our products or services fails to increase, or decreases, our business, financial condition and results of operations may be materially adversely affected.
−Removed: Our net revenues depend primarily on sales of the Invisalign System and iTero intraoral scanners and declines in volume or ASP may adversely affect net revenues, gross profit, operating profit and net income.
+Added: Our net revenues depend primarily on sales of the Invisalign System and iTero intraoral scanners and declines in volume or the average selling price (“ASP”) may adversely affect net revenues, gross profit, operating profit and net income.
Our net revenues are primarily dependent on sales of the Invisalign System an d iTero intraoral scanners.
Of the two, we expect the Invisalign System to continue to represent the majority of our net revenues and remain critical to our success.
−Removed: The ASPs of our products, particularly the Invisalign System, are influenced by numerous factors, including the mix of product treatment packages, geographical mix, channel mix and timing of products sold (particularly the timing and quantity of orders for additional clear aligners for certain Invisalign products), promotions and discounts and foreign currency exchange rates.
+Added: The ASPs of our products, particularly the Invisalign System, are influenced by numerous factors, including the mix of product treatment packages, geographical mix, channel mix and timing of products sold, promotions and discounts, inflation and foreign currency exchange rates.
In addition, we sell our products at different prices and with varying shipping and handling charges or processing fees that may differ by country.
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• we decrease prices or are unable to increase prices on one or more products or services in response to increasing competitive pricing pressures;
−Removed: • we introduce new or change existing products or services, or modify how we market or sell any of our new or existing products or services;
+Added: • we introduce new or change existing products or services, or modify how we market, lease or sell any of our new or existing products or services;
• we modify our pricing strategies for certain products or adjust pricing for certain items based on cancellation fees, shipping and handling charges or processing fees;
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• our critical accounting estimates materially differ from actual results.
−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 and releasing lower-priced products.
−Removed: These promotional campaigns and lower-priced products have had, and may in the future have, unexpected and unintended consequences, including reduced net revenues, gross profit, operating profit and net income.
−Removed: Competition in the markets for our products and services is increasing and we expect aggressive competition from existing competitors and emerging companies that introduce new technologies, products or services, and customers who alone or with others create orthodontic appliances and solutions or other products or services that compete with us.
−Removed: The dental industry is experiencing immense and rapid digital transformation, and we face competition from a variety of competitors including companies that specialize in products or systems and services that provide solutions similar to those that we offer.
−Removed: While solutions such as the Invisalign System, iTero intraoral scanners, CAD/CAM software and our digital platform facilitate this transition, we face competition from companies that seek to introduce new technologies and products and companies that remain dedicated to traditional products and services, such as wires and brackets, which doctors have historically been able to purchase at a lower price point.
−Removed: As we continue to expand globally, we may continue to encounter competition in different geographic regions.
−Removed: We have experienced price-focused competition in various markets and we anticipate this will continue.
−Removed: We may be unable to compete with these competitors, increased competition may result in commoditization of our products or services, or competitors may render our technology or products obsolete or economically unattractive, particularly as competitors incorporate artificial intelligence (“AI”) and machine learning into new or existing services and technologies that facilitate changes in doctor-patient interactions, expectations and treatment workflows.
+Added: We have a history of offering volume discounts, price reductions and other promotions to targeted customers and consumers and releasing lower priced products which have had, and may in the future have, unexpected and unintended consequences, including reduced net revenues, gross profit, operating profit and net income.
+Added: Competition in the markets for our products and services is increasing.
+Added: The dental industry is experiencing immense and rapid digital transformation and we may be unable to compete with existing competitors and emerging companies that introduce new technologies, products or services, and customers who alone or with others create orthodontic appliances and solutions or other products or services that compete with us.
+Added: While our product portfolio facilitates this transition, our competitors may render our technology or products obsolete or economically unattractive, particularly as competitors incorporate AI and machine learning into new or existing services and technologies that facilitate changes in doctor-patient interactions, expectations and treatment workflows.
We may be unable to devote adequate financial resources to develop or acquire new AI technologies and systems in the future and sufficiently meet evolving industry trends and consumer demands.
+Added: We also face competition from traditional products and services, such as wires and brackets, which doctors have historically been able to purchase at a lower price point.
+Added: We have and will likely continue to experience price-focused competition as we continue to expand into new markets, which could contribute to the commoditization of our products or services if we are unable to otherwise differentiate our offerings from those of our competitors.
The number and types of competitors we face are diverse and growing rapidly.
−Removed: The Invisalign System competes primarily against traditional wires and brackets and increasingly with clear aligners manufactured and distributed by new market entrants and existing competitors, including traditional medical device companies, laboratories, startups and, in some cases, doctors and dental service organizations (“DSOs”).
−Removed: Our competitors also include direct-to-consumer companies that provide clear aligners using a business model requiring little to no in-office care from trained and licensed doctors, and doctors and DSOs who manufacture custom aligners or procure products from third-party white-label providers.
+Added: The Invisalign System competes primarily against traditional wires and brackets and increasingly with clear aligners manufactured and distributed by new market entrants and existing competitors, including traditional medical device companies, laboratories, startups and, in some cases, doctors and DSOs.
+Added: Our competitors also include DTC companies that provide clear aligners using a business model requiring little to no in-office care from trained and licensed doctors, and doctors and DSOs who manufacture custom aligners or procure products from third-party white-label providers.
Large consumer product companies may also start supplying orthodontic products.
Orthodontists, GPs and DSOs have and may continue to sample competitive and alternative products, take advantage of competitive promotions and sale opportunities, or engage in “bait and switch,” “margin steering” or similar practices that take advantage of the significant brand recognition of Invisalign to offer alternative products.
−Removed: Our iTero intraoral scanners are also facing increased competition from new and existing competitors.
−Removed: Our scanners compete with polyvinyl siloxane impressions and numerous new and existing intraoral scanners and traditional impression methods, as well as traditional bite wing 2D dental X-rays and dental imaging systems that leverage near infrared imaging technology and AI for detecting interproximal caries.
+Added: Our iTero intraoral scanners compete with polyvinyl siloxane impressions and numerous new and existing intraoral scanners and traditional impression methods, as well as traditional bite wing 2D dental X-rays and dental imaging systems that leverage near infrared imaging technology and AI for detecting interproximal caries.
We have and may continue to experience competition with respect to our scanners and software solutions from competitors who introduce products at lower prices or with enhanced features or functionalities that better meets customer demand, including expansion of their portfolios in the digital ecosystem.
−Removed: If we are unable to compete effectively with existing products, existing competitors, new market entrants, or respond effectively to new technologies, our business, financial condition and results of operations could be materially adversely impacted.
−Removed: Our success depends on our ability to successfully develop, introduce, achieve market acceptance of, and manage new or improved products and services.
+Added: If we are unable to compete effectively with existing products, existing competitors, new market entrants, or
+Added: respond effectively to new technologies, our business, financial condition, and results of operations could be materially adversely impacted.
Our success depends on our ability to quickly and profitably develop, manufacture, market, and obtain and maintain regulatory approvals or clearances of new, improved or refurbished products and services.
The extent and rate at which our products or services achieve market acceptance and penetration depends on many factors, including our ability to:
−Removed: • successfully predict, timely innovate, develop, and launch new or improved technologies, applications, features, products and services to meet market demand and keep pace with changes in technology, customers’ demands and industry standards;
−Removed: • successfully and timely obtain regulatory approvals or clearances of new or improved products or services from government agencies such as the U.S.
−Removed: Food and Drug Administration (“FDA”) and analogous agencies in other countries;
−Removed: • cost-effectively and efficiently develop, manufacture, quality test, market, dispose of and sell new or improved products and services, including localized versions for international markets;
+Added: • cost-effectively and efficiently predict, timely innovate, develop, manufacture, quality test, market, launch, dispose of and sell new or improved technologies, applications, features, products and services to meet market demand and keep pace with changes in technology, customers’ demands and industry standards;
+Added: • successfully and timely obtain and maintain regulatory approvals or clearances of new or improved products or services from government agencies such as the FDA and analogous agencies in other countries;
• properly forecast the amount and timing of new or improved product and services demand;
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Introduction and acceptance of any products and services may take significant time and effort, particularly if they require doctor education and training to understand their benefits or doctors choose to withhold judgment on a product or service until patients complete their treatments.
−Removed: In addition, we periodically introduce new business and sales initiatives to meet customers’ needs and demands.
−Removed: In general, our internal resources support these initiatives without clear indications they will prove successful or be without short-term execution challenges.
+Added: In addition, we periodically introduce new business and sales initiatives to meet customers’ needs and demands, which may not be successful and may involve short-term execution challenges.
Should these initiatives fail, our business, financial condition and results of operations could be materially adversely impacted.
−Removed: We may invest in or acquire other businesses, products, technologies or other assets which may require significant management attention, disrupt our business, dilute stockholder value or adversely affect our business, financial condition and results of operations.
−Removed: We have and may in the future acquire, or make investments in, companies, businesses, products, technologies or other assets.
+Added: We may not realize the anticipated benefits of acquisitions, investments or other strategic transactions, and they may require significant management attention, disrupt our business, dilute stockholder value or adversely affect our business, financial condition and results of operations.
+Added: We have and may in the future acquire, or make investments in, companies, businesses, products, technologies or other assets, which may not ultimately strengthen our competitive position or achieve our desired synergies and integration.
Alternatively, we may be unable to find suitable investment or acquisition opportunities or be unable to complete investments or acquisitions on favorable terms.
−Removed: If we make such investments or complete acquisitions, we may not ultimately strengthen our competitive position or achieve desired synergies and integration.
−Removed: Moreover, the companies in which we do invest may fail or we may ultimately own less than a majority of the outstanding shares of the company and be unable to control or have significant influence over critical issues that could harm the value of our investment.
−Removed: We are subject to various risks when making a strategic investment or acquisition and integrating the operations and cultures of acquired businesses within our own, which could materially impact our business, financial condition or results of operations, including that we may:
+Added: We are subject to various risks when making a strategic investment or acquisition and integrating the operations and cultures of acquired businesses within our own, including that we may:
+Added: • ultimately own less than a majority of the outstanding shares of the company and be unable to control or have significant influence over critical issues that could harm the value of our investment;
• fail to perform proper due diligence and inherit unexpected material issues or assets, including intellectual property (“IP”) or other litigation or ongoing investigations, accounting irregularities or compliance liabilities;
−Removed: • fail to comply with regulations, governmental actions, orders or decrees;
• experience information technology (“IT”) security and privacy compliance issues;
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Operational Risks
−Removed: Our results of operations have and will continue to fluctuate in the future, which makes it difficult to predict the timing and amount of customer demand and our revenues, costs, and expenditures.
−Removed: Our quarterly and annual operating results have and will continue to fluctuate for a variety of reasons.
+Added: Our quarterly and annual results of operations have and will continue to fluctuate in the future, and we may not accurately predict the timing and amount of customer demand and our revenues, costs, and expenditures.
Some of the factors that have and could in the future cause our operating results to fluctuate include:
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• our acceptance of longer customer payment cycles;
−Removed: • changes in the timing of revenue recognition and our ASPs;
+Added: • changes in the timing of revenue recognition and our ASPs as a result of changes to the amount allocated to the standalone selling price of the distinct performance obligations under sales contracts;
• seasonal fluctuations;
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• timing and fluctuation of spending around marketing and brand awareness campaigns and industry trade shows.
−Removed: If we fail to accurately predict product demand, our manufacturing capacity or that of one or more of our suppliers, may be inadequate.
−Removed: Specifically, our manufacturing process relies on sophisticated computer software and requires new technicians to
−Removed: undergo a long training process, often 120 days or longer.
−Removed: Additionally, production levels for our iTero intraoral scanners are generally based on forecasts and historic demand and we often place orders with suppliers for materials, components, sub-assemblies and finished products weeks or more in advance of projected orders.
−Removed: If we do not hire and train the appropriate number of technicians in anticipation of demand, our costs and expenditures may not align with our revenues or revenue growth.
−Removed: 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.
−Removed: In addition, we may be required to purchase or lease additional or larger facilities and equipment to manage demand.
+Added: If we fail to accurately predict product demand, our manufacturing capacity, staffing, supplies, components, or materials, or those of one or more of our suppliers may be inadequate.
If we fail to timely manufacture and deliver products to meet demand, this could damage our relationships with existing customers or harm our ability to attract new customers and adversely affect our business, financial condition and results of operations.
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As a result, if our net revenues for a particular period are below expectations, we may be unable to timely or effectively reduce spending to offset any shortfalls.
−Removed: This variability and unpredictability could also result in our failing to meet the expectations of industry, financial analysts or investors.
+Added: Our results of operations may be adversely affected if doctors at DSOs, orthodontic service organizations (“OSOs”) or other large group practices reduce, delay, or do not increase their purchasing of our products and services in ways that reduce adoption of our products and services.
+Added: DSOs, OSOs and other large group practices have become an increasingly important channel for adoption of our products and services.
+Added: If doctors at DSOs, OSOs or other large group practices reduce, delay, or do not expand their purchasing of our products and services, or otherwise change priorities, protocols, or workflows in ways that reduce utilization of our products, demand for our products and services may not increase or may decrease, which could have a material impact on our business, financial condition and results of operations.
+Added: In addition, on behalf of the doctors in their affiliated practices, DSOs and other large group practices may have greater leverage to negotiate pricing, volume‑based discounts, rebates, extended payment terms, or other commercial concessions, which could adversely affect our ASPs, gross margins and profitability.
We are subject to operating risks, including excess or constrained capacity, operational inefficiencies and pressure on our internal systems, personnel and suppliers, including as a result of our past and any future restructuring efforts, which could adversely affect our results of operations.
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If one of these facilities is temporarily, partially or fully shut down, we may be unable to timely fulfill orders, which may negatively impact our reputation, business, financial condition and results of operations.
−Removed: Our IT systems are critical to our business.
−Removed: Issues with IT system and software integration, implementation, updates, and upgrades, or third-party software have previously and could again in the future disrupt our operations and have a material impact on our reputation, business, financial condition and results of operations.
+Added: Security breaches, data breaches, cybersecurity attacks, or other cybersecurity incidents could materially adversely impact our operations and patient care, and our reputation, business, financial condition and results of operations could be harmed.
+Added: Our IT systems, policies and contracts and the policies of our third-party vendors, and their IT systems safeguard employee, applicant and customer personal, health and financial, and our own proprietary information and data essential to our operations.
+Added: Our cybersecurity controls also depend on our customers, many of whom are individual or small healthcare providers with limited IT experience and inadequate or untested security protocols, to successfully manage data privacy and security requirements.
+Added: We and our service providers, third-party vendors and other third parties could be targeted by or subject to physical break-ins, computer viruses and other malicious code, unauthorized or fraudulent access, programming errors or other technical malfunctions, hacking attacks, phishing, vishing, deepfakes, and other social engineering attacks, malware, ransomware, employee noncompliance, error or malfeasance, cybersecurity attacks, malicious code, and other breaches of, or incidents impacting, IT systems or similar malicious or otherwise disruptive actions, including by organized groups and nation-state actors, which may disrupt or limit the availability of, or result in damage to, our IT systems and result in loss or unavailability of, damage to, or the unauthorized acquisition, use, disclosure, or other processing of confidential information.
+Added: We have experienced, and may again experience in the future, cybersecurity incidents, data incidents, and unauthorized internal employee exfiltration of information.
+Added: Our cybersecurity risk management program and processes, including our policies, controls or procedures, may not be successfully implemented, complied with or effective in protecting our systems and information or any other information we maintain or otherwise process.
+Added: Further, the frequency and sophistication of third-party cybersecurity attacks are increasing, particularly with the advancement of AI technologies.
+Added: Significant service disruptions, breaches, incidents, interruptions or other disruptive events impacting our infrastructure and IT systems, or other cybersecurity incidents, or any belief or reporting that any of the foregoing has occurred, could expose us to regulatory investigations, private claims, demands, litigation or other proceedings, impair our reputation and competitive position, distract management and require significant time and resources to address.
+Added: In addition, patient care could suffer, and we could be liable if our products, services or IT systems fail to timely deliver accurate and complete information.
+Added: Additionally, our iTero intraoral scanners may be independently or collectively the target of cybersecurity incidents or attacks or subject to security vulnerabilities, bugs, errors, defects, or viruses or other malicious code.
+Added: Due to the large and growing number of these decentralized devices, we may be unable, or not have the capacity, knowledge or infrastructure, to respond to or remedy a cybersecurity incident in a timely manner.
+Added: Any such cybersecurity incident may cause loss or damage to us, our customers or strategic business partners or may cause further malfunctions in, or damage to, our products, services, or IT systems, damage to, or loss, unavailability, or unauthorized acquisition, use, or other processing of our data, or disruption, interruption or temporary cessation of our operations.
+Added: Further, any such security breach or incident, or other cybersecurity incident, or any belief or reporting that any of the foregoing has occurred, may otherwise have a negative impact upon our business or reputation.
+Added: Issues with IT system and software integration, implementation, updates, and upgrades, or third-party software have previously and could again in the future disrupt our operations.
We rely on the efficient, uninterrupted, and secure operation of complex IT systems and are dependent on key third-party software embedded in IT systems as well as third-party hosted IT systems to support our operations, including third-party cloud platforms.
−Removed: All software and IT systems are vulnerable to damage, cybersecurity attacks, interruptions, or other disruptions from a variety of sources, including rapidly developing advanced technologies (e.g., generative and agentic AI technologies).
−Removed: To effectively manage and improve our operations, our IT systems and applications require an ongoing commitment of significant expenditures and resources to maintain, protect, upgrade, enhance and restore existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving industry and regulatory standards, including privacy, security and data protection laws, regulations and actions, increasingly sophisticated cybersecurity threats, and changing customer preferences.
+Added: To effectively manage and improve our operations, our IT systems and applications require an ongoing commitment of significant expenditures and resources to maintain, protect, upgrade, enhance, and restore existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving industry and regulatory standards, and changing customer preferences.
Usage of online and hosted technology platforms by us, our customers, and suppliers, including remote working, teledentistry, and new or expanded use of online service platforms, products, and solutions such as doctor, consumer, and patient apps have increased the demands on and risks to our IT systems and personnel.
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This entails certain risks, including operational disruptions, such as our ability to continue developing and updating products while addressing safety and security, track orders and timely ship products, manage our supply chain, and aggregate financial and operational data.
−Removed: Failure to adequately protect and maintain the integrity of our products, IT systems and data in those systems, and those of our suppliers and customers may materially impact our business, financial condition and results of operations.
+Added: Failure to adequately protect and maintain the integrity of our products, IT systems and data in those systems, and those of our suppliers and customers may materially impact our reputation, business, financial condition, and results of operations.
Additionally, we continuously upgrade and issue new software releases upon which customer facing manufacturing and treatment planning operations depend.
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Products in our Systems and Services segment, such as our iTero intraoral scanners, are subject to software and hardware risks that, if improperly managed, could have a material adverse impact on our business and financial results.
−Removed: Our Systems and Services segment is subject to software and hardware risks related to the manufacturing, design, quality and safety of our complex, global installed base of iTero intraoral scanners, which are continually updated to add, expand or improve features with new hardware or software we provide or components that we source, to integrate new or existing software or other components manufactured by third parties, or to provide repair or replacement parts, any of which may contain errors or exhibit failures, especially when first introduced.
+Added: Our Systems and Services segment is subject to software and hardware risks related to the manufacturing, design, quality and safety of our complex, global installed base of iTero intraoral scanners, which are continually updated to add, expand or improve features with new hardware or software, to integrate new or existing software or other components manufactured by third parties, or to provide repair or replacement parts, any of which may contain errors or exhibit failures, especially when products are first introduced.
We may be unable to ensure that third-party components or changes to them will be completely compatible with our scanners, which could cause our scanners to fail to perform as anticipated.
−Removed: Additionally, the third-party software integrated into or interoperable with our scanners routinely reach end of life, and as a consequence, certain applications and models may be exposed to additional vulnerabilities, including security risks, errors, and malfunctions that may be irreparable or difficult to repair.
+Added: Additionally, the third-party
+Added: software integrated into or interoperable with our scanners routinely reach end of life, and as a consequence, certain applications and models may be exposed to additional vulnerabilities, including security risks, errors, and malfunctions that may be irreparable or difficult to repair.
We may not timely and adequately remediate or implement corrective measures for such failures, including due to reliance on third-party providers or suppliers.
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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, and if we or third parties discontinue commercial availability or support for older versions of these scanners, our clear aligner revenues could be adversely impacted.
−Removed: Failures of all or any portion of our 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 system outages, regardless of cause, have harmed our operations previously and in the future could materially and adversely affect our ability to accept scans, manufacture clear aligners or restorative procedures or treatments and services, or otherwise service our customers.
+Added: Failures of all or any portion of our or third-party software or other components or systems to interoperate with iTero or third-party scanners, termination of interoperability with third-party scanners, 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 system outages, regardless of cause, have harmed our operations previously and in the future could materially and adversely affect our ability to accept scans, manufacture clear aligners or restorative procedures or treatments and services, or otherwise service our customers.
Any of these events could harm our sales, damage our reputation, adversely impact our strategic partners, or result in claims, demands, litigation, and liabilities, which could have a material effect on our reputation, business, financial condition or results of our operations and the operations of our customers or business partners.
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We are highly dependent on our supply chain, particularly manufacturers of specialized and customized scanning equipment, rapid prototyping machines, resin and other advanced materials, as well as the optics, electronic and other mechanical components of our iTero scanners.
−Removed: We maintain single and sole supply relationships for many of these machines and materials.
−Removed: Using single and sole suppliers in limited locations for materials and manufacturing exposes us to multiple supply chain vulnerabilities.
+Added: We maintain single and sole supply relationships in limited locations for materials and manufacturing, which exposes us to multiple supply chain vulnerabilities.
We are reliant upon manufacturers that we contract with for quality and stability and any failures on their part may have an impact on our ability to supply our products.
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In addition, we earn an increasingly larger portion of our total revenues from international sales, which carry higher shipping costs that negatively impact our gross margin and results of operations.
−Removed: If freight costs materially increase and we are unable to successfully pass all or significant portions of the increases along to our customers, or we cannot otherwise offset such increases, our gross margin and financial results could be materially affected.
+Added: If freight costs materially increase and we are unable to successfully pass all or significant
+Added: portions of the increases along to our customers, or we cannot otherwise offset such increases, our gross margin and financial results could be materially affected.
If we cannot attract, motivate, train or retain personnel, it will be difficult to achieve our strategic priorities, which could materially adversely affect our business, financial condition and results of operations.
−Removed: We are highly dependent on the talent and efforts of our personnel.
−Removed: We strive to retain our personnel by providing competitive compensation and benefits, development opportunities and training, and an inclusive corporate culture.
−Removed: However, competition for highly skilled personnel, particularly technical and digital talent, is intense, and our competitors have and are likely to continue to recruit our personnel.
−Removed: Our compensation and benefit arrangements may not successfully attract new personnel or retain and motivate existing personnel.
−Removed: In addition, other internal and external factors can impact our ability to hire and retain talent, including insufficient advancement or career opportunities, in office, hybrid or remote work policies, restrictive immigration policies, and our past and any future restructuring efforts, such as the restructuring plans we have implemented in each of the past three fiscal years, and most recently in the third quarter of 2025.
−Removed: The loss of any key personnel, particularly executive management, research and development, or sales personnel, could harm our business and prospects and impede the achievement of our research and development, operational or strategic objectives.
−Removed: We provide significant training to our personnel and our business will be harmed if our training fails to properly prepare them to perform the work required, we are unable to successfully instill technical expertise in new and existing personnel, or if our techniques prove unsuccessful or are not cost-effective.
−Removed: Moreover, for certain roles, this training and experience can make key personnel, such as our sales personnel, highly desirable to competitors and lead to increased attrition.
−Removed: It can take 12 months or more to train sales representatives to successfully market and sell our products and services and for them to establish strong customer relationships.
−Removed: The loss of the services and knowledge of our highly skilled personnel may significantly delay or prevent the achievement of our development, operational or strategic objectives.
−Removed: Additionally, seamless leadership transitions for key positions are critical to sustaining our culture and organizational success.
+Added: The loss of the services and knowledge of any key personnel, particularly executive management, research and development, or sales personnel, could harm our business and prospects and impede the achievement of our research and development, operational or strategic objectives.
+Added: Competition for highly skilled personnel, particularly technical and digital talent, is intense, and traditional and emerging competitors have and are likely to continue to recruit our personnel as the dental industry undergoes rapid digital transformation on a global scale.
+Added: Various internal and external factors can impact our ability to hire and retain talent, including o ur compensation and benefit arrangements, advancement or career opportunities at our organization, and our past and any future restructuring efforts, such as the restructuring plans we have implemented in each of the past three fiscal years, and most recently in the third quarter of 2025.
+Added: Additionally, approximately 91% of our employees are located internationally, and restrictive immigration or travel policies or legal or regulatory developments relating to immigration in the United States and other countries may negatively affect our efforts to attract, motivate, train or retain qualified personnel.
+Added: Seamless leadership transitions for key positions are critical to sustaining our culture and organizational success.
If our succession planning is ineffective, it could adversely impact our business.
−Removed: Moreover, future organizational changes may cause attrition rates to increase.
−Removed: If we fail to effectively manage any organizational or strategic changes, our financial condition, results of operations, and reputation, as well as our ability to successfully attract, motivate, and retain key personnel, may be adversely affected.
−Removed: Effective September 1, 2025, we required that employees return to working five days per week in the office for most locations.
−Removed: Many companies, including companies that we compete with for talent, have adopted work policies and arrangements that our employees may consider to be more appealing, which could impact our ability to attract and retain qualified personnel.
−Removed: We believe a key to our success has been the culture we have created that emphasizes a shared vision and core values of Agility, Customer and Accountability.
−Removed: We have experienced and may continue to experience difficulties attracting and retaining personnel that meet the qualifications, experience, compliance mindset and values we expect.
−Removed: If we cannot attract and retain personnel that meet our selection criteria or relax our standards, our corporate culture, ability to achieve our strategic objectives and our compliance with obligations under our internal controls and other requirements may be harmed.
−Removed: This could have a material adverse effect on our results of operations and our ability to maintain market share.
+Added: Organizational changes, such as our past and any future restructuring efforts, such as the restructuring plans we have implemented in each of the past three fiscal years, and most recently in the third quarter of 2025, may increase attrition and adversely impact our ability to successfully attract, motivate, and retain key personnel.
+Added: In September, 2025, we required most of our employees to return to working five days per week in the office for most locations, which could impact our ability to attract and retain qualified personnel, particularly if companies that we compete with for talent have adopted work policies and arrangements that our employees may consider to be more appealing.
+Added: We have experienced and may continue to experience difficulties attracting and retaining personnel that meet the qualifications, experience, compliance mindset and values we expect and share our core values of Agility, Customer and Accountability, which could impact our ability to achieve our strategic objectives and maintain compliance with obligations under our internal controls and other requirements.
+Added: We provide significant training and experience to our personnel that, for certain roles, can make key personnel, such as our commercial and sales personnel, highly desirable to competitors and lead to increased attrition.
We have personnel represented by works councils and trade unions in certain countries and others that may be or may become eligible to be represented by works councils, trade unions and other employee associations.
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The harm of negative publicity, particularly on social media platforms, may be immediate, without affording us an opportunity for redress or correction.
−Removed: In addition, many countries prohibit certain types of marketing activities.
−Removed: For example, some countries restrict direct to consumer advertising of medical devices.
+Added: In addition, many countries prohibit certain types of marketing activities, such as direct to consumer advertising of medical devices.
We have and may in the future be alleged to violate marketing restrictions and be ordered to stop certain marketing activities or prevented from selling our products and services.
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We are subject to antitrust and competition regulations, litigation and enforcement that may result in fines, penalties, restrictions on our business practices, and product, services or operational changes which could materially impact our business, financial condition and results of operations.
−Removed: We currently are and may in the future be subject to antitrust, competition or unfair competition-related investigations, enforcement actions or claims by governmental agencies, competitors, consumers, customers and others which, even if unfounded, could cause us to incur substantial costs, enter into settlements, consent decrees, be subject to judgments, involve negative publicity and divert management time and attention, which may materially impact our business, financial condition and results of operations.
−Removed: Resolving these matters may require us to change our business in ways that could have a material adverse effect on our business practices, revenues and results of operations.
−Removed: Governments and regulators are actively developing new competition laws, regulations and actions aimed at the technology sector, AI and digital platforms, and global activities and expansion, including in large markets such as the United States, the European Union (“EU”), and China.
−Removed: Government regulatory actions and court decisions may result in fines or hinder our ability to provide certain benefits to our customers and consumers, reducing the attractiveness of our products, services and the net revenue derived from them.
−Removed: These actions and decisions may also hinder our ability to pursue certain mergers, acquisitions, business combinations, investments or other transactions.
+Added: We currently are and may in the future be subject to antitrust, competition or unfair competition-related investigations, enforcement actions or claims by governmental agencies, competitors, consumers, customers and others which, even if unfounded, could cause us to incur substantial costs (including fines), enter into settlements or consent decrees, be subject to judgments, receive negative publicity, forego certain mergers, acquisitions, business combinations, investments or other transactions, divert management time and attention, or change our business in ways that could have a material adverse effect on our business practices, revenues and results of operations, such as limiting our ability to provide certain benefits to our customers and consumers, reducing the attractiveness of our products, services and the net revenue derived from them.
+Added: Governments and regulators are actively developing new competition laws, regulations and actions aimed at the technology sector, AI and digital platforms, and global activities and expansion, including in large markets such as the United States, the EU, and China.
+Added: For more information, see Note 6 “ Legal Proceedings” of the Notes to Condensed Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form 10-Q.
+Added: Antitrust considerations may also hinder our ability to settle such matters on favorable terms, as certain types of settlement agreements may be subject to heightened scrutiny by antitrust authorities.
+Added: In the E.U., for instance, antitrust regulators closely monitor settlement agreements for compliance with competition laws, adding another layer of complexity and potential risk to these proceedings.
Failure to obtain or maintain approvals or comply with regulations and government actions regarding our products or services or those of our suppliers could materially harm our sales, result in substantial penalties and fines, interrupt our supply chain and cause harm to our reputation.
−Removed: We and many of our healthcare provider customers, suppliers and commercial intermediaries are subject to extensive and frequently changing regulations and government actions under numerous federal, state, local, and foreign laws, including those regulating:
+Added: We and many of our healthcare provider customers, suppliers and commercial intermediaries are subject to extensive and evolving regulations and government actions under numerous federal, state, local, and foreign laws, including those regulating:
• the access, storage, transmission, disclosure, and other processing of, and security measures with respect to, personal, financial and medical information as well as healthcare records, including children’s personal and health data;
−Removed: • websites and application advertising, including that involving the use of cookies or involving the collection, use, disclosure, or other processing of data relating to individuals for marketing purposes and other business purposes;
+Added: • websites and application advertising, including those involving the use of cookies or involving the collection, use, disclosure, or other processing of data relating to individuals for marketing purposes and other business purposes;
• prohibitions against the offer, payment or receipt of remuneration to induce referrals to entities providing healthcare services or goods or to induce the order, purchase or recommendation of our products and services;
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There can be no assurance we will adequately address the 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.
−Removed: Furthermore, before we can sell a new medical device or market a new use of, or claim for, an existing product, we frequently must obtain regulatory clearance or approval.
+Added: Furthermore, we frequently must obtain regulatory clearance or approval before we can sell a new medical device or market a new use of, or claim for, an existing product.
For instance, in the United States, FDA regulations are wide-ranging and govern, among other things, product design, product materials, development, manufacturing and testing, product labeling and product storage.
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Additionally, failure to comply with applicable regulatory requirements could result in enforcement actions with sanctions, including fines, civil penalties and criminal prosecution.
−Removed: Delays or failures to obtain or maintain regulatory approvals, clearances or to comply with regulatory requirements may materially adversely affect our domestic or international operations, and adversely impact our business.
+Added: Delays or failures to obtain or maintain regulatory approvals or clearances, or to comply with regulatory requirements, may materially adversely affect our domestic or international operations, and adversely impact our business.
We and certain of our third-party vendors must also comply with and adhere to facility registration and product listing requirements for Quality System regulations.
4 unchanged sentences
Bribery Act of 2010, which generally prohibit payments to foreign officials for the purpose of obtaining or maintaining business, securing an advantage and directing business to another.
−Removed: To comply with ABAC laws, regulators require we maintain accurate books and records and a system of internal accounting controls.
+Added: ABAC laws require us to maintain accurate books and records and a system of internal accounting controls.
Under the FCPA, we may be held liable for corruption by directors, officers, employees, agents, or other strategic or local partners, intermediaries or representatives acting on our behalf.
−Removed: While we have policies and procedures requiring compliance with applicable laws and regulations and we provide training to foster compliance, our employees, third parties acting on our behalf, and customers may not adhere to our policies and procedures or applicable laws or regulations, including the use of certain electronic communications and maintaining accurate books and records.
+Added: While we have policies and procedures requiring compliance with applicable laws and regulations and we provide training to foster compliance, our employees, third parties acting on our behalf, and customers may not adhere to our policies and
+Added: procedures or applicable laws or regulations, including the use of certain electronic communications and maintaining accurate books and records.
If our personnel or the personnel of our agents or suppliers fail to comply with any laws, regulations, policies or procedures, or we fail to audit and enforce compliance, our reputation may be harmed, we may lose customers or revenues or we may face regulatory investigations, actions and fines.
−Removed: In June 2024, the U.S.
−Removed: Supreme Court reversed its longstanding approach to evaluating administrative rulemaking under the Chevron doctrine, which provided for judicial deference to regulatory agencies, including the FDA.
−Removed: Following this decision, there may be increased challenges to existing agency regulations or how lower courts will apply the decision in the context of other regulatory schemes without more specific guidance from the courts.
−Removed: For example, this decision may result in more companies suing the FDA to challenge its longstanding decisions and policies, which could undermine the FDA's authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, which could impact the timely review of any regulatory filings or applications we submit.
−Removed: In 2025, there have been significant and wide-ranging reforms to federal policy and the federal government including significant workforce reductions across federal agencies.
−Removed: We may be impacted by inadequate funding for government agencies or other disruptions to or reductions in federal agencies including obtaining and maintaining clearances and approvals of our products and services.
−Removed: Over the last several years, and most recently on October 1, 2025, the U.S.
−Removed: federal government has shut down several times, which has, for instance, required federal agencies such as the FDA to furlough critical employees and stop critical activities.
−Removed: If a prolonged government shutdown were to occur, it could significantly affect the FDA’s timely review of any regulatory filings or applications we submit, which could result in delays or failures to obtain or maintain regulatory approvals, clearances or to comply with regulatory requirement.
−Removed: The rapid increase in new or changed government regulations could result in significant costs and expenses, including those related to compliance, and require modifications in the way we and our customers conduct business.
−Removed: If we are unable to respond to changing regulations in a timely and effective manner, our business, financial condition and results of operations could materially adversely be impacted.
−Removed: Security breaches, data breaches, cybersecurity attacks, other cybersecurity incidents, or the failure to comply with privacy, security and data protection laws could materially adversely impact our operations and patient care, and we could be liable for damages, and our reputation, business, financial condition and results of operations could be harmed.
−Removed: We retain confidential employee, applicant and customer personal, health and financial, and our own proprietary information and data essential to our operations.
−Removed: We rely on the effectiveness of our IT systems, policies and contracts and the policies of our third-party vendors and their IT systems, to safeguard information and data.
−Removed: Additionally, our cybersecurity controls depend on our customers, many of whom are individual or small healthcare providers with limited IT experience and inadequate or untested security protocols, to successfully manage data privacy and security requirements.
−Removed: It is critical that the facilities, infrastructure and IT systems on which we depend and the products and services we develop remain and be perceived as secure.
−Removed: Despite security features in our products and services and security measures in our IT systems, we and our service providers, third-party vendors and other third parties could be targeted by or subject to physical break-ins, computer viruses and other malicious code, unauthorized or fraudulent access, programming errors or other technical malfunctions, hacking attacks, phishing, vishing, deepfakes, and other social engineering attacks, malware, ransomware, employee noncompliance, error or malfeasance, cybersecurity attacks, malicious code, and other breaches of, or incidents impacting, IT systems or similar malicious or otherwise disruptive actions, including by organized groups and nation-state actors, which may disrupt or limit the availability of, or result in damage to, our IT systems and result in loss or unavailability of, damage to, or the unauthorized acquisition, use, disclosure, or other processing of confidential information.
−Removed: For example, we have experienced, and may again experience in the future, cybersecurity incidents, data incidents, and unauthorized internal employee exfiltration of information.
−Removed: These risks are exacerbated with the advancement of technologies like AI, which can be used to create new, more sophisticated and more frequent or other attacks.
−Removed: There can be no assurance our cybersecurity risk management program and processes, including our policies, controls or procedures, will be fully implemented, complied with or effective in protecting our systems and information or any other information we maintain or otherwise process.
−Removed: Further, the frequency and sophistication of third-party cybersecurity attacks are increasing.
−Removed: Significant service disruptions, breaches, incidents, interruptions or other disruptive events impacting our infrastructure and IT systems, or other cybersecurity incidents, or any belief or reporting that any of the foregoing has occurred, could expose us to regulatory investigations, or other proceedings, private claims, demands, and litigation, impair our reputation and competitive position, distract management and require significant time and resources to address.
−Removed: Legal or regulatory action against us could prevent us from resolving issues quickly or force us to resolve them in unanticipated ways, cause us to incur significant expense and damages, or result in orders forcing us to cease operations or modify our business practices in ways that materially limit or restrict our products and services.
−Removed: Concerns over our practices with respect to privacy, data protection, data governance, and cybersecurity could adversely affect our reputation and deter customers and consumers from using our products and services.
−Removed: In addition, patient care could suffer, and we could be liable if our products, services or IT systems fail to timely deliver accurate and complete information.
+Added: We are subject to various laws relating to privacy, data protection, data governance and cybersecurity, and face risks related to the data we collect, process, and share.
+Added: We are or may become, or alleged to be or become, subject to stringent federal, state, and foreign laws and regulations, such as HIPAA, which regulates the security and privacy of patient healthcare information applicable to healthcare providers and their business associates, and the California Consumer Protection Act, as amended by the California Privacy Rights Act, which regulates privacy, data security, content regulation and consumer protection.
+Added: Numerous other states have enacted, or plan to enact, laws relating to privacy, data protection, data governance and cybersecurity, with such enacted laws either in operation or slated to go into operation over the next several years.
+Added: Outside of the United States, relevant legal requirements continue to evolve.
+Added: For example, the collection and use of health data and other personal information is governed in the EU by the EU GDPR, which imposes significant obligations upon companies and rights for individuals, with substantial penalties for noncompliance.
+Added: Numerous other jurisdictions maintain similar legislation or other laws or regulations addressing privacy, data protection, data governance, or cybersecurity.
+Added: Several jurisdictions, including the EU, United States, China, Australia, and Japan, have enacted data export restrictions and international transfer laws and regulations that established legal requirements for cross-border transfers of all or certain personal information and certain jurisdictions have also established legal requirements for data localization, which may require us to maintain separate servers located in those countries so that all or certain personal information are maintained locally.
+Added: These laws, regulations and other obligations relating to privacy, data protection, data governance and cybersecurity are constantly evolving and may be created, interpreted or enforced in ways that could impose new, substantially uncertain, and relatively burdensome obligations on our global operations, restrict our activities and our ability to provide our products and services in certain jurisdictions, require us to cease operations or modify our policies and business practices in a materially limiting manner, prevent us from resolving issues quickly or force us to resolve them in unanticipated ways, require us to engage in additional contractual negotiations, increase our costs and obligations and limit our ability to efficiently transfer personal data across borders, cause us to incur significant costs, expenses and damages, and present challenges in adapting our policies and practices to address their requirements.
+Added: Any failure or perceived failure by us or our vendors, customers, or service providers to comply with applicable privacy and data protection laws or to adequately safeguard personal data or patient healthcare information, even if unfounded, may result in regulatory investigations, enforcement actions, litigation (including class actions), and financial penalties, any of which could materially affect our operations and financial performance.
+Added: Additionally, concerns over our practices with respect to privacy, data protection, data governance, and cybersecurity could adversely affect our reputation and deter customers and consumers from using our products and services.
We have cybersecurity and other forms of insurance coverage related to cyberattacks, breaches, and other incidents or security problems, but we cannot guarantee applicable insurance will be available to us in the future on economically reasonable terms or at all.
Damages and claims arising from incidents may not be covered, may exceed coverage limits, and may not cover the time and effort we incur investigating and responding to any incidents, or other costs or liabilities, which may be material.
−Removed: The costs to eliminate, mitigate, or recover from security problems and cybersecurity attacks and incidents
−Removed: could be material and require us to implement additional or different security controls or other measures and, depending on the nature and extent of the problem and the products, services or IT systems impacted, such security problems and cybersecurity attacks and incidents may result in network, IT system interruptions or other disruptions, decreased product sales, data loss, damage, unavailability, or other liabilities, any of which may have a material impact on our operations, net revenues and operating results.
+Added: The costs to eliminate, mitigate, or recover from security problems and cybersecurity attacks and incidents could be material and require us to implement additional or different security controls or other measures and, depending on the nature and extent of the problem and the products, services or IT systems impacted, such security problems and cybersecurity attacks and incidents may result in network, IT system interruptions or other disruptions, decreased product sales, data loss, damage, unavailability, or other liabilities, any of which may have a material impact on our operations, net revenues and operating results.
The costs associated with cybersecurity tools and infrastructure and competition for scarce cybersecurity and IT resources could limit our ability to identify, eliminate or remediate cybersecurity or other security vulnerabilities or problems or enact changes to minimize the attack surface of our network.
−Removed: Additionally, our iTero intraoral scanners may be independently or collectively the target of cybersecurity incidents or attacks or subject to security vulnerabilities, bugs, errors, defects, or viruses or other malicious code.
−Removed: Due to the large and growing number of these decentralized devices, we may be unable, or not have the capacity, knowledge or infrastructure, to respond to or remedy a cybersecurity incident in a timely manner.
−Removed: Any such cybersecurity incident may cause loss or damage to us, our customers or strategic business partners or may cause further malfunctions in, or damage to, our products, services, or IT systems, damage to, or loss, unavailability, or unauthorized acquisition, use, or other processing of our data, or disruption, interruption or temporary cessation of our operations.
−Removed: Further, any such security breach or incident, or other cybersecurity incident, or any belief or reporting that any of the foregoing has occurred, may otherwise have a negative impact upon our business or reputation.
−Removed: We also are or may become, or alleged to be or become, subject to certain federal, state, and foreign laws and regulations respecting the security and privacy of patient healthcare information applicable to healthcare providers and their business associates, such as the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the HIPAA Standards for Privacy of Individually Identifiable Health Information and the Security Standards for the Protection of Electronic Protected Health Information under HIPAA and the Health Information Technology for Economic and Clinical Health Act of 2009, as well as those relating to privacy, data security, content regulation and consumer protection, such as the California Consumer Protection Act, as amended by the California Privacy Rights Act (as amended, the “CCPA”).
−Removed: The CCPA requires covered businesses that process personal information of California residents to disclose certain practices, provides California residents with data privacy rights, imposes operational requirements, and provides for significant civil penalties for violations as well as a private right of action for certain data breaches and statutory damages.
−Removed: There are limited exemptions under the CCPA for protected health information covered by HIPAA and certain other state laws, but the CCPA and other new and evolving state laws could impact our business activities.
−Removed: Numerous other states have enacted, or plan to enact, laws relating to privacy, data protection, data governance and cybersecurity, with such enacted laws either in operation or slated to go into operation over the next several years.
−Removed: Many of these laws are comprehensive privacy laws similar to the CCPA.
−Removed: States also are enacting laws addressing specific subject matter, such as Washington’s My Health, My Data Act, which includes a private right of action.
−Removed: Laws in all 50 U.S.
−Removed: states have required notice to individuals whose personal data has been disclosed as a result of a data breach.
−Removed: Outside of the U.S., relevant legal requirements continue to evolve.
−Removed: For example, the collection and use of health data and other personal information is governed in the EU by the General Data Protection Regulation, which imposes significant obligations upon companies and rights for individuals, with substantial penalties for noncompliance up to the greater of €20,000,000 or 4% of the total worldwide annual turnover of the preceding financial year, and by certain EU member state-level legislation.
−Removed: Numerous other jurisdictions maintain similar legislation or other laws or regulations addressing privacy, data protection, data governance, or cybersecurity.
−Removed: We are also subject to data export restrictions and international transfer laws and regulations that prohibit or impose conditions upon certain data transfers.
−Removed: The mechanisms upon which we and many other companies rely for European data transfers have been the subject of legal challenge, regulatory interpretation and judicial decisions by the EU courts and regulators, and may be subject to significant changes.
−Removed: Several jurisdictions, including the EU, the United States, China, Australia, and Japan, have established legal requirements for cross-border transfers of all or certain personal information and certain jurisdictions have also established legal requirements for data localization, which may require us to maintain separate servers located in those countries so that all or certain personal information are maintained locally.
−Removed: These laws and regulations addressing cross-border data transfers and data localization are constantly evolving and may be created, interpreted, applied or amended in ways that could restrict our activities in certain jurisdictions, limit our ability to provide our products and services in those jurisdictions, require us to modify our policies and practices and to engage in additional contractual negotiations, or increase our costs and obligations and impose limitations upon our ability to efficiently transfer personal data across borders.
−Removed: We have and likely will again in the future be required to implement new or expand existing data storage protocols, build new storage facilities, devote additional resources, and modify relevant policies or procedures to comply with the foregoing laws and regulations, any of which could be costly and which may adversely affect our business and our customers' businesses, our financial condition and our results of operations in those jurisdictions.
−Removed: With laws, regulations and other obligations relating to privacy, data protection, data governance and cybersecurity imposing new and relatively burdensome obligations, and with substantial uncertainty over the interpretation and application of these and other obligations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices and may incur significant costs and expenses in an effort to do so.
−Removed: Further, any failure or perceived failure by us or our vendors, customers, or service providers to comply with our applicable policies or notices relating to privacy, data protection, data governance or cybersecurity, our contractual or other obligations to third parties, or any of our other legal obligations, laws, rules, regulations, government actions or standards relating to privacy, data protection, data governance or cybersecurity, may result in governmental investigations or enforcement actions, litigation, claims and other proceedings, harm our reputation, and could result in significant liability.
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.
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Current and anticipated sustainability and social (“Sustainability”) laws and scrutiny of our Sustainability policies and practices may materially increase our costs, expose us to liability, and adversely impact our reputation, employee retention, willingness of customers and suppliers to do business with us and willingness of investors to invest in us.
−Removed: Our operations are subject to a variety of existing local, regional and global Sustainability laws and regulations, and we are and may be required to comply with new, broader, more complex and more costly laws and regulations, such as the EU’s Corporate Sustainability Reporting Directive.
+Added: Our operations are subject to rapidly changing and varied expectations and requirements regarding Sustainability issues from a wide range of stakeholders, such as governmental and self-regulatory organizations, including U.S.
+Added: federal and state governments, and the EU, as well as investor advocacy groups, institutional investors, investment funds, proxy advisory services, stockholders and customers.
+Added: We are also required to comply with disclosure obligations under the SEC’s long-standing climate change disclosure guidance and other SEC regulations, as well as the European Union’s Corporate Sustainability Reporting Directive (“CSRD”).
+Added: If we fail to adopt Sustainability standards or practices as quickly as stakeholders desire, comply with or timely report on our Sustainability efforts or practices accurately, or satisfy the disclosure and other expectations of stakeholders, our brand, reputation, employee retention, business, financial performance, growth, and stock price may be adversely impacted.
Our compliance obligations 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, workers’ and human rights.
−Removed: Sustainability regulations 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 from power generated by fossil fuels.
−Removed: The effects of greenhouse gas emission limits on power generation are subject to significant uncertainties, including the timing of new requirements, levels of emissions reductions and the scope and types of emissions regulated.
−Removed: Additionally, as Sustainability laws are increasing, customers and consumers may demand our products, packaging and operations be more sustainable, affect how we manufacture and package our products, increase our costs and those of our suppliers, and may result in manufacturing, transportation and supply chain disruptions if clean energy sources are unavailable in adequate amounts when required.
+Added: Additionally, customers and consumers may demand our products, packaging and operations be more sustainable, which could affect how we manufacture and package our products, increase our costs and those of our suppliers, and result in manufacturing, transportation and supply chain disruptions if clean energy sources are unavailable in adequate amounts when required.
Moreover, clean energy sources, coupled with reduced investments in traditional energy production and infrastructure, may not provide the predictable and reliable energy we, our suppliers and other business partners require.
−Removed: Additionally, the sourcing and availability of metals used in the manufacture of, or contained in, our products may be affected by laws and regulations governing the use of minerals obtained from certain regions like the Democratic Republic of Congo and adjoining countries.
−Removed: Our expanding geographic operations may increase the risk of purchasing “conflict minerals” and our efforts to identify whether any of our products contain minerals impacted by these laws and regulations may not be accurate, adequate or complete.
Other restrictions apply to the substances incorporated into our products, including the chemical compounds in our clear aligners, electronics in our scanners and the packaging in which they are shipped.
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In all of these situations, customers may stop purchasing products from us, and may take legal action against us, which could harm our reputation, business, financial condition and results of operations.
−Removed: Investor advocacy groups, institutional investors, investment funds, proxy advisory services, stockholders and customers have and could in the future focus on corporate Sustainability practices.
−Removed: Additionally, public interest and legislative pressure related to companies’ Sustainability practices has been evolving in recent years.
−Removed: If we fail to adopt Sustainability standards or practices as quickly as stakeholders desire, comply with or timely report on our Sustainability efforts or practices accurately, or satisfy the disclosure and other expectations of stakeholders, our brand, reputation, employee retention, business, financial performance, growth, and stock price may be adversely impacted.
−Removed: Implementation of AI and machine learning technologies may result in legal and regulatory risks, reputational harm or have other adverse consequences to our business.
−Removed: We have and are continuing to incorporate AI, including machine learning and independent algorithms, in certain of our products, services and IT systems, which is intended to enhance their operation and effectiveness internally and for our customers, consumers and suppliers.
−Removed: There can be no assurance that we or our customers will realize the expected benefits from these investments.
+Added: AI and machine learning technologies in our products, services and IT systems may result in legal and regulatory risks, reputational harm or have other adverse consequences to our business.
+Added: We have and are continuing to incorporate AI and machine learning technologies into certain of our products, services and IT systems, while continuing to explore the opportunities that AI could bring to our company.
+Added: However, there can be no assurance that we or our customers will realize the expected benefits from these investments.
AI innovation presents risks and challenges that could impact our business.
−Removed: Our, or our vendors’, AI
−Removed: algorithms or datasets may be flawed, insufficient or contain biased information, and could lead to the dissemination of false information.
−Removed: Additionally, many countries and regions, including the EU, have proposed new and evolving regulations related to the use of AI and machine learning technologies.
+Added: Our or our vendors’ AI technologies may be developed using inaccurate, incomplete, flawed or biased algorithms, training methodologies or data, which could lead to the dissemination of false information and result in competitive harm, regulatory penalties, legal liability, or brand or reputational harm.
+Added: AI is subject to a dynamic and rapidly evolving legal and regulatory environment, which, without appropriate review, governance and risk management, could expose us to unforeseen legal or regulatory scrutiny and liabilities.
+Added: For example, the U.S.
+Added: AI regulatory framework remains in development and has been introduced at the federal level through executive orders and legislation has been introduced and enacted at the state level.
In Europe, the EU AI Act entered into force on August 1, 2024 which will become fully effective on August 2, 2026, with some provisions effective in February 2025.
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Additionally, other jurisdictions have proposed, and in certain cases enacted, laws and regulations addressing aspects of the use and development of AI.
−Removed: The evolving AI regulatory environment may, among other impacts, result in:
−Removed: • inconsistencies among AI regulations and frameworks across jurisdictions;
+Added: The evolving AI regulatory environment may, among other impacts, result in inconsistencies among AI regulations and frameworks across jurisdictions;
onerous compliance, governance, and research and development obligations that may require us to rework or reevaluate products or services to be compliant or result in the development of products that are unacceptable under new or revised regulatory frameworks;
−Removed: • increased risk of regulatory enforcement and litigation related to our AI models;
+Added: increased risk of exposure to investigations, proceedings and claims related to our AI models;
increased liability related to the use of AI by our customers, consumers or suppliers beyond our control;
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competitive and reputational harm;
−Removed: • increased cybersecurity risks.
+Added: and increased cybersecurity risks.
+Added: Additionally, as we offer more third-party AI models in our solutions, we face risks inherent in how third-party AI models used in our solutions have been developed and deployed, including situations in which the third party may lack a proper license or consent for the training data used for their model.
+Added: The use and availability of third-party AI models in our solutions could result in scrutiny and legal liability, including intellectual property infringement claims.
+Added: Such claims or scrutiny could cause
+Added: reputational harm and loss of customers, and adversely impact our business and financial results.
+Added: In addition, new competition regulations on AI development and deployment could impose new requirements on our markets that could impact our business and financial results.
The input of confidential information or trade secrets into AI systems may result in the loss of intellectual property, proprietary rights or attorney-client privilege in such information or trade secrets.
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however, these patents may not prevent third parties from producing competing products similar in design to ours if they are invalidated, held unenforceable, circumvented or otherwise limited in scope.
−Removed: Furthermore, our foreign patent protections may be more limited in geographic scope than those under U.S.
+Added: Furthermore, our foreign patent protections may be more limited in scope than those under U.S.
patent and IP laws.
Additionally, any of our patent applications may not result in an issued patent or the scope of the patent ultimately issued may be narrower than initially sought.
−Removed: We may not be afforded the protection of a patent if our currently pending or future patent filings do not result in the issuance of patents or we fail to timely apply for patent protection.
−Removed: We may not apply for a patent if our personnel fail to disclose or recognize new patentable ideas or innovations.
+Added: We may not be afforded the protection of a patent if our currently pending or future patent filings do not result in the issuance of patents or if we fail to timely apply for patent protection.
+Added: We may not apply for a patent if our personnel fail to timely disclose or recognize new patentable ideas or innovations.
We may choose not to file a foreign patent application if the limited protections provided by a foreign patent do not outweigh the costs to obtain it.
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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.
+Added: Furthermore, if these agreements are breached through the unauthorized use or disclosure of our trade secrets or other confidential information, available remedies may be insufficient to adequately compensate for damages caused by the unauthorized use or disclosure, even with successful enforcement of a breach of contract or trade secret claim.
Enforcement of our IP rights is time-consuming and costly, and could ultimately prove to be unsuccessful.
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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.
−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 growth prospects.
−Removed: 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.
+Added: Our inability to maintain the proprietary nature of our technology through patents, copyrights, or trade secrets could impair our competitive advantages and could have a material effect on our operating results, financial condition, and future growth prospects.
+Added: In particular, failure in protecting and enforcing 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.
Litigation regarding our IP rights, rights claimed by third parties or IP litigation by any vendors on whose products or services we rely for our products and services may impact our ability to grow our business and adversely impact our reputation and results of operations.
Extensive litigation over IP rights is common in technologies and industries on which our products and services are based.
−Removed: Litigation, interferences, oppositions, re-exams, inter partes reviews, post grant reviews or other proceedings have been
−Removed: necessary and will likely be needed in the future to determine the validity and scope of certain of our IP rights and those claimed by third parties.
−Removed: These proceedings are used to determine the validity, scope or non-infringement of certain patent rights pertinent to the manufacture, use or sale of our products and the products of competitors.
+Added: Litigation, interferences, oppositions, reexaminations, inter partes reviews, post-grant reviews or other proceedings have been necessary and will likely be needed in the future to determine the validity and scope of certain of our IP rights and those claimed by third parties.
+Added: These proceedings are used to determine the validity, scope or non-infringement of certain IP rights pertinent to the manufacture, use or sale of our products and the products of competitors.
We have been, and may in the future be, sued and need to defend against lawsuits alleging infringement of third parties’ IP rights or other legal claims challenging our IP rights.
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As dentistry continues to become more digital, competitors may make defense of our IP more challenging.
−Removed: Asserting or defending these proceedings can be unpredictable, protracted, time-consuming, expensive, and distracting to management and technical personnel.
+Added: Asserting or defending these proceedings can be unpredictable (e.g., due to differences in forums, judges, and jurisdictions;
+Added: case law that continues to evolve with time;
+Added: changes in administrative policies, etc.), protracted, time-consuming, expensive, and distracting to management and technical personnel.
Their outcomes may adversely affect our ability to manufacture and market our products and services, require us to seek licenses for infringing products or technologies, or result in the assessment of significant monetary damages.
−Removed: Unfavorable rulings could include monetary damages, injunctions prohibiting us from selling our products, or exclusion orders preventing us from importing our products in one or more countries.
−Removed: Moreover, independent actions by competitors, customers, or others have alleged that our efforts to enforce our IP rights constitute unfair competition or violations of antitrust laws and investigations and additional litigation based on the same or similar claims may be brought in the future.
+Added: Unfavorable rulings could also include monetary damages, injunctions prohibiting us from selling our products, or exclusion orders preventing us from importing our products in one or more countries.
+Added: Moreover, independent actions by competitors, customers, or others have alleged that our
+Added: efforts to enforce our IP rights constitute unfair competition or violations of antitrust laws.
+Added: Investigations and additional litigation based on the same or similar claims may be brought in the future.
The potential effects on our business operations resulting from litigation, whether or not ultimately determined in our favor or settled by us, are costly and could materially affect our reputation, business, financial condition and results of operations.
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The qualitative analysis performed by management to identify indicators of impairment or the quantitative analysis used to determine fair value requires management to exercise significant judgment in determining appropriate assumptions and estimates, including revenue growth rates, gross and operating margins, and discount rates.
−Removed: Management is responsible for continually assessing qualitative factors that could negatively impact the fair value of goodwill and finite-lived intangible and long-lived assets and if required, assesses the fair value of each to determine if they have become impaired.
Consequently, we may be required to record material charges to income during the period in which any impairment of goodwill, finite-lived intangible assets or long-lived assets is determined.
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We are required to annually assess our internal control over financial reporting and any adverse results from such assessment may result in a loss of investor confidence in our financial reports and adversely affect our stock price.
−Removed: We are required to furnish in our Annual Report on Form 10-K a report by management regarding the effectiveness of our internal control over financial reporting that includes, among other things, an assessment of the effectiveness of our internal control over financial reporting as of the end of our fiscal year, including an assertion by management that our internal control over financial reporting were effective as of the end of our fiscal year.
−Removed: Our internal controls may become ineffective because of changes in personnel, updates and upgrades to or migration away from existing software, failure to maintain accurate books and records, changes in accounting standards or interpretations of existing standards, or changes to business models that may require adjustments to our financial reporting and, as a result, the degree of compliance of our internal control over financial reporting with the existing policies or procedures may become ineffective.
Establishing, testing and maintaining an effective system of internal control over financial reporting requires significant resources and time commitments by management and our finance staff, and may require additional staffing and infrastructure investments and increases our costs of doing business.
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Our effective tax rate may vary significantly from period to period, which could result in volatility of our operating results and adversely affect our financial results.
−Removed: We are subject to taxes in the United States and foreign countries.
−Removed: Various internal and external factors may impact our future effective tax rate.
−Removed: These include changes in the global economic environment, our legal entity structure or activities performed within our entities, our business operations, tax laws, regulations and/or rates, changes to existing accounting pronouncements, changes in interpretations of existing tax laws or regulations, the relative proportions of revenues and income before taxes in the various jurisdictions in which we operate that have differing statutory tax rates, overall levels of pretax earnings, settlements of income tax audits, non-deductible goodwill impairments, and changes in the valuation allowance offsetting deferred tax assets.
+Added: Our future effective tax rate may be impacted by various internal and external factors, such as changes in the global economic environment, our legal entity structure or activities performed within our entities, our business operations, tax laws, regulations and/or rates, changes to existing accounting pronouncements, changes in interpretations of existing tax laws or regulations, the relative proportions of revenues and income before taxes in the various jurisdictions in which we operate that have differing statutory tax rates, overall levels of pretax earnings, settlements of income tax audits, non-deductible goodwill impairments, and changes in the valuation allowance offsetting deferred tax assets.
Furthermore, we may continue to experience variation in our effective tax rate related to excess tax benefits or tax expense on stock-based compensation, particularly in the first quarter of each year when the majority of our equity awards vest.
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Compliance with tax laws requires significant judgment concerning our worldwide provision for income taxes.
−Removed: Changes in tax laws or changes to how those laws are applied to our business could affect the amount of tax which we are subject to and the manner in which we operate.
−Removed: Specifically, the Organization for Economic Cooperation and Development (“OECD”) established the Inclusive Framework on Base Erosion and Profit Shifting to among other things, allocate greater taxing rights to countries where customers are located and establish a global minimum tax rate.
−Removed: Countries including EU member countries have enacted, are considering enacting, or have committed to enact the OECD/G20 Framework’s Pillar Two 15% global minimum tax, including Switzerland which is a significant jurisdiction for us.
−Removed: On June 28, 2025, the G7 released a joint statement announcing an understanding regarding a proposed “side-by-side” solution that would exempt U.S.-parented multinational businesses from certain provisions of the global minimum tax;
−Removed: however, no agreement regarding implementation of the proposal has been reached yet.
−Removed: On July 4, 2025, the United States enacted tax reform legislation commonly referred to as the One Big Beautiful Bill Act.
−Removed: Included in this legislation are provisions that allow for the immediate expensing of certain domestic research and development expenses and of certain capital expenditures, and other changes to the U.S.
−Removed: taxation of profits derived from foreign operations.
+Added: Changes in tax laws, such as the Inclusive Framework on Base Erosion and Profit Shifting (“BEPS”) established by Organization for Economic Cooperation and Development (“OECD”), the OECD/G20 Framework’s Pillar Two 15% global minimum tax, and the One Big Beautiful Bill Act, or changes to how those laws are applied to our business could affect the amount of tax which we are subject to and the manner in which we operate.
We continue to monitor the enactment of legislation to evaluate the impact of changing global tax laws, which could adversely affect our provision for income taxes or operations.
−Removed: 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.
+Added: 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.
states, local and foreign taxing jurisdictions have differing rules and regulations governing differing types of taxes, and these rules and regulations are subject to varying interpretations and exemptions that may change over time.
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Furthermore, there have been and will continue to be substantial ongoing costs associated with complying with the various tax requirements and defending our positions in the numerous markets in which we conduct or will conduct business.
+Added: Risks Related to Ownership of our Common Stock
Historically, the market price for our common stock has been volatile.
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• changes in recommendations or valuation models for our stock by the investment community, or speculation in the press or investment community regarding estimates of our net revenues, results of operations, or other key performance indicators;
+Added: • negative publicity or unfavorable consumer perceptions, whether accurate or inaccurate, concerning our products or the company;
• announcements by us, our competitors, or new market entrants, including strategic actions, management changes, and material transactions, investments or acquisitions;
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In addition, the stock market in general, and the market for technology and medical device companies, in particular, often experience extreme price and volume fluctuations unrelated or disproportionate to corporate operating performance.
−Removed: Any such fluctuations have and may continue to adversely affect the market price of our common stock.
−Removed: These broad market and industry factors may include market expectations of, or actual changes in, monetary policies that have the goal of easing or tightening interest rates such as the U.S.
−Removed: federal funds rate and austerity measures of governments intended to control budget deficits.
−Removed: Securities litigation, including securities class action lawsuits and securities derivative lawsuits, is often brought against an issuer following periods of volatility in the market price of its securities and we have not been exempt from such litigation.
−Removed: We cannot guarantee that we will continue to repurchase our common stock in the future, and any repurchases we may make may not achieve our desired objectives.
−Removed: We have a history of stock repurchase programs intended to return capital to our investors.
+Added: Volatility in our stock price has increased, and may continue to increase, our susceptibility to securities class action litigation, which could result in substantial costs and divert management’s attention and resources, which may adversely affect our business.
+Added: We may not continue repurchasing our common stock and any repurchases may not achieve our desired objectives.
Future stock repurchase programs are contingent on a variety of factors, including our financial condition, market conditions, results of operations, business requirements, and our continuing determination that stock repurchases are in the best interests of our stockholders and in compliance with all applicable laws and agreements.
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Sales of substantial amounts of our stock by existing stockholders may adversely affect the market price of our stock by creating the perception of difficulties or problems with our business, which may depress our stock price.
+Added: Our business could be negatively impacted as a result of shareholder activism.
+Added: Publicly traded companies are increasingly subject to campaigns by activist shareholders advocating corporate actions such as operational, governance or management changes, or sales of assets or entire segments.
+Added: We are currently subject to shareholder activism and may continue to be in the future.
+Added: The corporate actions by shareholder activists may not align with our current business strategies and the best interests of all of our stakeholders.
+Added: The actions of activist shareholders may cause fluctuations in our stock price based on temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals or prospects of our business.
+Added: In addition, responding to the actions of activist shareholders can be costly and time-consuming, disrupting our business and diverting the attention of our board of directors and management from pursuing our business strategies.
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.