10-K – 2026-02-27 – algn-20251231.htm

Automatiskt nyckeltalsindex

Detta är sökträffar och textkontext, inte verifierade eller normaliserade redovisningsvärden.

Fulltext

Dokumentet är delat för att hålla varje sida lätt att hämta. Del 1 · Del 2 · Del 3

algn-20251231 false 2025 FY 0001097149 P7Y P1Y http://fasb.org/us-gaap/2025#AccruedLiabilitiesCurrent http://fasb.org/us-gaap/2025#AccruedLiabilitiesCurrent P2Y http://fasb.org/us-gaap/2025#RevenueFromContractWithCustomerExcludingAssessedTax http://fasb.org/us-gaap/2025#RevenueFromContractWithCustomerExcludingAssessedTax http://fasb.org/us-gaap/2025#RevenueFromContractWithCustomerExcludingAssessedTax http://fasb.org/us-gaap/2025#NonoperatingIncomeExpense 1.9 http://fasb.org/us-gaap/2025#CostOfRevenue http://www.aligntech.com/20251231#RestructuringAndOtherCharges iso4217:USD xbrli:shares iso4217:USD xbrli:shares algn:segment xbrli:pure iso4217:EUR iso4217:CAD iso4217:GBP iso4217:PLN iso4217:ILS iso4217:JPY iso4217:BRL iso4217:CNY iso4217:CHF iso4217:TWD iso4217:NZD iso4217:KPW iso4217:AUD iso4217:CZK algn:patent algn:action algn:period 0001097149 2025-01-01 2025-12-31 0001097149 2025-06-30 0001097149 2026-02-20 0001097149 2024-01-01 2024-12-31 0001097149 2023-01-01 2023-12-31 0001097149 2025-12-31 0001097149 2024-12-31 0001097149 us-gaap:CommonStockMember 2022-12-31 0001097149 us-gaap:AdditionalPaidInCapitalMember 2022-12-31 0001097149 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-12-31 0001097149 us-gaap:RetainedEarningsMember 2022-12-31 0001097149 2022-12-31 0001097149 us-gaap:RetainedEarningsMember 2023-01-01 2023-12-31 0001097149 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-01-01 2023-12-31 0001097149 us-gaap:CommonStockMember 2023-01-01 2023-12-31 0001097149 us-gaap:AdditionalPaidInCapitalMember 2023-01-01 2023-12-31 0001097149 us-gaap:CommonStockMember 2023-12-31 0001097149 us-gaap:AdditionalPaidInCapitalMember 2023-12-31 0001097149 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-12-31 0001097149 us-gaap:RetainedEarningsMember 2023-12-31 0001097149 2023-12-31 0001097149 us-gaap:RetainedEarningsMember 2024-01-01 2024-12-31 0001097149 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2024-01-01 2024-12-31 0001097149 us-gaap:CommonStockMember 2024-01-01 2024-12-31 0001097149 us-gaap:AdditionalPaidInCapitalMember 2024-01-01 2024-12-31 0001097149 us-gaap:CommonStockMember 2024-12-31 0001097149 us-gaap:AdditionalPaidInCapitalMember 2024-12-31 0001097149 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2024-12-31 0001097149 us-gaap:RetainedEarningsMember 2024-12-31 0001097149 us-gaap:RetainedEarningsMember 2025-01-01 2025-12-31 0001097149 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2025-01-01 2025-12-31 0001097149 us-gaap:CommonStockMember 2025-01-01 2025-12-31 0001097149 us-gaap:AdditionalPaidInCapitalMember 2025-01-01 2025-12-31 0001097149 us-gaap:CommonStockMember 2025-12-31 0001097149 us-gaap:AdditionalPaidInCapitalMember 2025-12-31 0001097149 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2025-12-31 0001097149 us-gaap:RetainedEarningsMember 2025-12-31 0001097149 algn:HeartlandMember 2023-04-24 0001097149 algn:HeartlandMember 2023-04-24 2024-04-22 0001097149 algn:HeartlandMember 2024-04-22 2024-04-22 0001097149 algn:HeartlandMember 2023-04-24 2023-04-24 0001097149 algn:SDHoldingCompanyMember 2025-06-05 0001097149 algn:SDHoldingCompanyMember 2024-12-19 2025-06-05 0001097149 algn:HeartlandMember 2025-01-01 2025-12-31 0001097149 algn:HeartlandMember 2024-01-01 2024-12-31 0001097149 algn:HeartlandMember 2025-12-31 0001097149 srt:MinimumMember 2025-12-31 0001097149 srt:MaximumMember 2025-12-31 0001097149 us-gaap:ServiceLifeMember algn:SpecificallyIdentifiedManufacturingAssetsMember 2025-01-01 2025-12-31 0001097149 algn:ClearAlignerMember 2025-01-01 2025-12-31 0001097149 algn:IntraoralScannersMember 2025-01-01 2025-12-31 0001097149 algn:CADCAMSoftwareMember 2025-01-01 2025-12-31 0001097149 algn:InvisalignMember 2025-01-01 2025-12-31 0001097149 algn:InvisalignMember 2025-07-01 2025-12-31 0001097149 algn:SystemsAndServicesMember 2025-01-01 2025-12-31 0001097149 algn:SystemsAndServicesMember 2025-01-01 2025-12-31 0001097149 algn:SystemsAndServicesMember 2026-01-01 2025-12-31 0001097149 us-gaap:CashMember 2025-12-31 0001097149 us-gaap:CashAndCashEquivalentsMember us-gaap:CashMember 2025-12-31 0001097149 us-gaap:MoneyMarketFundsMember 2025-12-31 0001097149 us-gaap:MoneyMarketFundsMember us-gaap:CashAndCashEquivalentsMember 2025-12-31 0001097149 us-gaap:CertificatesOfDepositMember 2025-12-31 0001097149 us-gaap:CertificatesOfDepositMember us-gaap:CashAndCashEquivalentsMember 2025-12-31 0001097149 us-gaap:CashAndCashEquivalentsMember 2025-12-31 0001097149 us-gaap:CashMember 2024-12-31 0001097149 us-gaap:CashAndCashEquivalentsMember us-gaap:CashMember 2024-12-31 0001097149 us-gaap:MoneyMarketFundsMember 2024-12-31 0001097149 us-gaap:MoneyMarketFundsMember us-gaap:CashAndCashEquivalentsMember 2024-12-31 0001097149 us-gaap:CashAndCashEquivalentsMember 2024-12-31 0001097149 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2025-12-31 0001097149 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2025-12-31 0001097149 us-gaap:CertificatesOfDepositMember us-gaap:FairValueMeasurementsRecurringMember 2025-12-31 0001097149 us-gaap:CertificatesOfDepositMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2025-12-31 0001097149 us-gaap:FairValueInputsLevel1Member 2025-12-31 0001097149 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2024-12-31 0001097149 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember us-gaap:FairValueInputsLevel1Member 2024-12-31 0001097149 us-gaap:FairValueInputsLevel1Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember 2025-01-01 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember 2024-01-01 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember 2023-01-01 2023-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:EUR us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:CAD us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:GBP us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:PLN us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:ILS us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:JPY us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:BRL us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:CNY us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:CHF us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:TWD us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:NZD us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:KPW us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:AUD us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:CZK us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember us-gaap:FairValueInputsLevel2Member 2025-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:EUR us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:PLN us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:CAD us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:GBP us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:ILS us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:CNY us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:BRL us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:JPY us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:CHF us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:NZD us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:CZK us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:AUD us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:TWD us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember currency:KPW us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 us-gaap:ForeignExchangeForwardMember us-gaap:FairValueInputsLevel2Member 2024-12-31 0001097149 srt:MaximumMember us-gaap:EquipmentMember 2025-12-31 0001097149 us-gaap:EquipmentMember 2025-12-31 0001097149 us-gaap:EquipmentMember 2024-12-31 0001097149 us-gaap:BuildingMember 2025-12-31 0001097149 us-gaap:BuildingMember 2024-12-31 0001097149 us-gaap:LeaseholdImprovementsMember 2025-12-31 0001097149 us-gaap:LeaseholdImprovementsMember 2024-12-31 0001097149 algn:ComputerSoftwareAndHardwareMember 2025-12-31 0001097149 algn:ComputerSoftwareAndHardwareMember 2024-12-31 0001097149 us-gaap:LandMember 2025-12-31 0001097149 us-gaap:LandMember 2024-12-31 0001097149 srt:MinimumMember algn:FurnitureFixturesAndOtherMember 2025-12-31 0001097149 srt:MaximumMember algn:FurnitureFixturesAndOtherMember 2025-12-31 0001097149 algn:FurnitureFixturesAndOtherMember 2025-12-31 0001097149 algn:FurnitureFixturesAndOtherMember 2024-12-31 0001097149 us-gaap:ConstructionInProgressMember 2025-12-31 0001097149 us-gaap:ConstructionInProgressMember 2024-12-31 0001097149 algn:CubicureMember 2024-01-02 0001097149 algn:CubicureMember 2024-01-02 2024-01-02 0001097149 algn:CubicureMember algn:ExistingTechnologyMember 2024-01-02 2024-01-02 0001097149 algn:ClearAlignerMember 2023-12-31 0001097149 algn:SystemsAndServicesMember 2023-12-31 0001097149 algn:ClearAlignerMember 2024-01-01 2024-12-31 0001097149 algn:SystemsAndServicesMember 2024-01-01 2024-12-31 0001097149 algn:ClearAlignerMember 2024-12-31 0001097149 algn:SystemsAndServicesMember 2024-12-31 0001097149 algn:ClearAlignerMember 2025-01-01 2025-12-31 0001097149 algn:SystemsAndServicesMember 2025-01-01 2025-12-31 0001097149 algn:ClearAlignerMember 2025-12-31 0001097149 algn:SystemsAndServicesMember 2025-12-31 0001097149 algn:ExistingTechnologyMember 2025-01-01 2025-12-31 0001097149 algn:ExistingTechnologyMember 2025-12-31 0001097149 us-gaap:CustomerRelationshipsMember 2025-01-01 2025-12-31 0001097149 us-gaap:CustomerRelationshipsMember 2025-12-31 0001097149 us-gaap:TrademarksAndTradeNamesMember 2025-01-01 2025-12-31 0001097149 us-gaap:TrademarksAndTradeNamesMember 2025-12-31 0001097149 us-gaap:PatentsMember 2025-01-01 2025-12-31 0001097149 us-gaap:PatentsMember 2025-12-31 0001097149 us-gaap:TrademarksAndTradeNamesMember 2024-01-01 2024-12-31 0001097149 algn:ExistingTechnologyMember 2024-01-01 2024-12-31 0001097149 algn:ExistingTechnologyMember 2024-12-31 0001097149 us-gaap:CustomerRelationshipsMember 2024-01-01 2024-12-31 0001097149 us-gaap:CustomerRelationshipsMember 2024-12-31 0001097149 us-gaap:TrademarksAndTradeNamesMember 2024-12-31 0001097149 us-gaap:PatentsMember 2024-01-01 2024-12-31 0001097149 us-gaap:PatentsMember 2024-12-31 0001097149 us-gaap:RevolvingCreditFacilityMember algn:CreditFacility2022Member 2025-12-31 0001097149 us-gaap:LetterOfCreditMember algn:CreditFacility2022Member 2025-12-31 0001097149 algn:AntitrustClassActionsMember 2024-06-01 2024-06-30 0001097149 algn:AntitrustClassActionsMember 2025-01-01 2025-12-31 0001097149 algn:AntitrustClassActionsMember 2024-12-31 0001097149 algn:AntitrustClassActionsMember 2025-01-01 2025-03-31 0001097149 algn:StraumannLitigationMember 2025-04-14 0001097149 algn:StraumannLitigationMember 2025-04-12 0001097149 algn:StraumannLitigationMember 2025-04-10 0001097149 algn:StraumannLitigationMember 2025-10-23 0001097149 algn:StraumannLitigationMember 2025-10-27 0001097149 algn:StraumannLitigationMember 2025-11-06 0001097149 algn:AngelalignTechnologyInc.ActionsMember 2025-08-15 2025-08-15 0001097149 algn:AngelalignTechnologyInc.ActionsMember us-gaap:SubsequentEventMember 2026-02-12 2026-02-12 0001097149 algn:AngelalignTechnologyInc.ActionsMember 2025-08-18 2025-08-18 0001097149 us-gaap:HerMajestysRevenueAndCustomsHMRCMember 2024-03-31 0001097149 us-gaap:HerMajestysRevenueAndCustomsHMRCMember 2024-10-31 0001097149 algn:StockIncentivePlan2005Member 2025-12-31 0001097149 us-gaap:CostOfSalesMember 2025-01-01 2025-12-31 0001097149 us-gaap:CostOfSalesMember 2024-01-01 2024-12-31 0001097149 us-gaap:CostOfSalesMember 2023-01-01 2023-12-31 0001097149 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2025-01-01 2025-12-31 0001097149 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2024-01-01 2024-12-31 0001097149 us-gaap:SellingGeneralAndAdministrativeExpensesMember 2023-01-01 2023-12-31 0001097149 us-gaap:ResearchAndDevelopmentExpenseMember 2025-01-01 2025-12-31 0001097149 us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-12-31 0001097149 us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-12-31 0001097149 us-gaap:RestrictedStockUnitsRSUMember 2025-01-01 2025-12-31 0001097149 us-gaap:RestrictedStockUnitsRSUMember 2024-12-31 0001097149 us-gaap:RestrictedStockUnitsRSUMember 2025-12-31 0001097149 us-gaap:RestrictedStockUnitsRSUMember 2024-01-01 2024-12-31 0001097149 us-gaap:RestrictedStockUnitsRSUMember 2023-01-01 2023-12-31 0001097149 algn:MarketPerformanceBasedRestrictedStockUnitsMember 2025-01-01 2025-12-31 0001097149 algn:MarketPerformanceBasedRestrictedStockUnitsMember 2024-12-31 0001097149 algn:MarketPerformanceBasedRestrictedStockUnitsMember 2025-12-31 0001097149 algn:MarketPerformanceBasedRestrictedStockUnitsMember 2024-01-01 2024-12-31 0001097149 algn:MarketPerformanceBasedRestrictedStockUnitsMember 2023-01-01 2023-12-31 0001097149 us-gaap:PerformanceSharesMember 2024-12-31 0001097149 us-gaap:PerformanceSharesMember 2025-01-01 2025-12-31 0001097149 us-gaap:PerformanceSharesMember 2025-12-31 0001097149 us-gaap:EmployeeStockMember 2010-05-01 2010-05-31 0001097149 2010-05-01 2010-05-31 0001097149 us-gaap:EmployeeStockMember 2021-05-31 0001097149 us-gaap:EmployeeStockMember 2025-12-31 0001097149 us-gaap:EmployeeStockMember 2025-01-01 2025-12-31 0001097149 us-gaap:EmployeeStockMember 2024-01-01 2024-12-31 0001097149 us-gaap:EmployeeStockMember 2023-01-01 2023-12-31 0001097149 algn:January2023RepurchaseProgramMember 2023-01-31 0001097149 algn:April2025RepurchaseProgramMember 2023-01-31 0001097149 algn:April2025RepurchaseProgramMember 2025-01-01 2025-12-31 0001097149 algn:April2025RepurchaseProgramMember 2025-12-31 0001097149 algn:January2023AcceleratedShareRepurchaseProgramMember algn:FourthQuarter2023Member 2023-10-01 2023-12-31 0001097149 algn:January2023OpenMarketRepurchaseProgramMember algn:FourthQuarter2023Member 2023-10-01 2023-12-31 0001097149 algn:January2023OpenMarketRepurchaseProgramMember algn:SecondQuarter2024Member 2024-04-01 2024-06-30 0001097149 algn:January2023OpenMarketRepurchaseProgramMember algn:FourthQuarter2024Member 2024-10-01 2024-12-31 0001097149 algn:January2023OpenMarketRepurchaseProgramMember algn:FirstQuarter2025Member 2025-01-01 2025-03-31 0001097149 algn:April2025OpenMarketRepurchaseProgramMember algn:ThirdQuarter2025Member 2025-07-01 2025-09-30 0001097149 algn:April2025OpenMarketRepurchaseProgramMember srt:ScenarioForecastMember 2025-08-05 2026-01-31 0001097149 algn:April2025OpenMarketRepurchaseProgramMember 2025-12-31 0001097149 algn:April2025OpenMarketRepurchaseProgramMember us-gaap:SubsequentEventMember 2026-01-01 2026-01-31 0001097149 algn:A401kPlanMember 2025-01-01 2025-12-31 0001097149 country:US algn:A401kPlanMember 2025-01-01 2025-12-31 0001097149 country:US algn:A401kPlanMember 2024-01-01 2024-12-31 0001097149 country:US algn:A401kPlanMember 2023-01-01 2023-12-31 0001097149 us-gaap:ForeignPlanMember 2025-01-01 2025-12-31 0001097149 us-gaap:ForeignPlanMember 2024-01-01 2024-12-31 0001097149 us-gaap:ForeignPlanMember 2023-01-01 2023-12-31 0001097149 country:CH 2025-01-01 2025-12-31 0001097149 country:MX 2025-01-01 2025-12-31 0001097149 us-gaap:ForeignTaxJurisdictionOtherMember 2025-01-01 2025-12-31 0001097149 country:US 2025-01-01 2025-12-31 0001097149 us-gaap:ForeignCountryMember 2025-12-31 0001097149 country:IL 2025-01-01 2025-12-31 0001097149 us-gaap:RestrictedStockUnitsRSUMember 2025-01-01 2025-12-31 0001097149 us-gaap:EmployeeStockMember 2025-01-01 2025-12-31 0001097149 us-gaap:RestrictedStockUnitsRSUMember 2024-01-01 2024-12-31 0001097149 us-gaap:RestrictedStockUnitsRSUMember 2023-01-01 2023-12-31 0001097149 us-gaap:EmployeeStockMember 2023-01-01 2023-12-31 0001097149 us-gaap:OperatingSegmentsMember algn:ClearAlignerMember 2025-01-01 2025-12-31 0001097149 us-gaap:OperatingSegmentsMember algn:ClearAlignerMember 2024-01-01 2024-12-31 0001097149 us-gaap:OperatingSegmentsMember algn:ClearAlignerMember 2023-01-01 2023-12-31 0001097149 us-gaap:OperatingSegmentsMember algn:SystemsAndServicesMember 2025-01-01 2025-12-31 0001097149 us-gaap:OperatingSegmentsMember algn:SystemsAndServicesMember 2024-01-01 2024-12-31 0001097149 us-gaap:OperatingSegmentsMember algn:SystemsAndServicesMember 2023-01-01 2023-12-31 0001097149 us-gaap:CorporateNonSegmentMember 2025-01-01 2025-12-31 0001097149 us-gaap:CorporateNonSegmentMember 2024-01-01 2024-12-31 0001097149 us-gaap:CorporateNonSegmentMember 2023-01-01 2023-12-31 0001097149 us-gaap:OperatingSegmentsMember 2025-01-01 2025-12-31 0001097149 us-gaap:OperatingSegmentsMember 2024-01-01 2024-12-31 0001097149 us-gaap:OperatingSegmentsMember 2023-01-01 2023-12-31 0001097149 country:US 2025-01-01 2025-12-31 0001097149 country:US 2024-01-01 2024-12-31 0001097149 country:US 2023-01-01 2023-12-31 0001097149 country:CH 2025-01-01 2025-12-31 0001097149 country:CH 2024-01-01 2024-12-31 0001097149 country:CH 2023-01-01 2023-12-31 0001097149 algn:OtherInternationalMember 2025-01-01 2025-12-31 0001097149 algn:OtherInternationalMember 2024-01-01 2024-12-31 0001097149 algn:OtherInternationalMember 2023-01-01 2023-12-31 0001097149 country:CH 2025-12-31 0001097149 country:CH 2024-12-31 0001097149 country:US 2025-12-31 0001097149 country:US 2024-12-31 0001097149 algn:OtherInternationalMember 2025-12-31 0001097149 algn:OtherInternationalMember 2024-12-31 0001097149 algn:RestructuringPlan2023Member 2023-01-01 2023-12-31 0001097149 algn:RestructuringPlan2023Member 2023-12-31 0001097149 algn:RestructuringPlan2023Member 2024-12-31 0001097149 algn:RestructuringPlan2024Member 2024-01-01 2024-12-31 0001097149 algn:RestructuringPlan2024Member 2024-12-31 0001097149 algn:RestructuringPlan2024Member 2025-01-01 2025-12-31 0001097149 algn:RestructuringPlan2025Member 2025-07-01 2025-09-30 0001097149 us-gaap:CostOfSalesMember algn:RestructuringPlan2025Member 2025-01-01 2025-12-31 0001097149 algn:RestructuringAndOtherChargesMember algn:RestructuringPlan2025Member 2025-01-01 2025-12-31 0001097149 algn:RestructuringPlan2025Member 2025-12-31 0001097149 algn:RestructuringPlan2024Member 2023-12-31 0001097149 algn:RestructuringPlan2023Member 2024-01-01 2024-12-31 0001097149 algn:RestructuringPlan2025Member 2024-12-31 0001097149 algn:RestructuringPlan2025Member 2025-01-01 2025-12-31 0001097149 algn:RestructuringPlan2024Member 2025-12-31 0001097149 algn:JuarezMexicoManufacturingFacilityMember 2025-09-30 0001097149 algn:JuarezMexicoManufacturingFacilityMember 2025-01-01 2025-12-31 0001097149 2025-10-01 2025-12-31 0001097149 us-gaap:AllowanceForCreditLossMember 2022-12-31 0001097149 us-gaap:AllowanceForCreditLossMember 2023-01-01 2023-12-31 0001097149 us-gaap:AllowanceForCreditLossMember 2023-12-31 0001097149 us-gaap:AllowanceForCreditLossMember 2024-01-01 2024-12-31 0001097149 us-gaap:AllowanceForCreditLossMember 2024-12-31 0001097149 us-gaap:AllowanceForCreditLossMember 2025-01-01 2025-12-31 0001097149 us-gaap:AllowanceForCreditLossMember 2025-12-31 0001097149 us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember 2022-12-31 0001097149 us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember 2023-01-01 2023-12-31 0001097149 us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember 2023-12-31 0001097149 us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember 2024-01-01 2024-12-31 0001097149 us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember 2024-12-31 0001097149 us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember 2025-01-01 2025-12-31 0001097149 us-gaap:ValuationAllowanceOfDeferredTaxAssetsMember 2025-12-31

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________________________________________________________________
FORM 10-K
 ________________________________________________________________________
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31 , 2025
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                     to                    
Commission file number: 000-32259
________________________________________________________________________
ALIGN TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
________________________________________________________________________
Delaware 94-3267295
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)

410 North Scottsdale Road, Suite 1300
Tempe , Arizona 85288
(Address of principal executive offices, including zip code)
(602)   742-2000
(Registrant’s telephone number, including area code)
________________________________________________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, $0.0001 par value ALGN The Nasdaq Stock Market LLC

(Nasdaq Global Select Market)

Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.     Yes    ☒     No   ☐
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes   ☐      No    ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.     Yes    ☒     No   ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).     Yes    ☒     No   ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☒ Accelerated filer   ☐
Non-accelerated filer   ☐ Smaller reporting company   ☐
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes   ☐     No   ☒
The aggregate market value of the common stock held by non-affiliates of the registrant was approximately $ 11.1 billion as of June 30, 2025, based on the closing sales price of the registrant’s common stock on the Nasdaq Global Select Market on such date. Shares held by persons who may be deemed affiliates have been excluded. This determination of affiliate status is not necessarily a conclusive determination for other purposes.
On February 20, 2026, 71,282,132 shares of the registrant’s common stock were outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant’s definitive Proxy Statement relating to its 2026 annual meeting of stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. The registrant’s definitive proxy statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates.
1

ALIGN TECHNOLOGY, INC.
FORM 10-K
For the Year Ended December 31, 2025
TABLE OF CONTENTS
 

    Page
PART I   
3

Item 1. Business
3

Information about our Executive Officers
22

Item 1A. Risk Factors
22

Item 1B. Unresolved Staff Comments
36

Item 1C. Cybersecurity
36

Item 2. Properties
38

Item 3. Legal Proceedings
38

Item 4. Mine Safety Disclosures
38

PART II
39

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
39

Item 6. [Reserved]
41

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
41

Item 7A. Quantitative and Qualitative Disclosures About Market Risk
54

Item 8. Financial Statements and Supplementary Data
56

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
97

Item 9A. Controls and Procedures
97

Item 9B. Other Information
97

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
97

PART III
97

Item 10. Directors, Executive Officers and Corporate Governance
97

Item 11. Executive Compensation
98

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
98

Item 13. Certain Relationships and Related Transactions, and Director Independence
99

Item 14. Principal Accountant Fees and Services
99

PART IV
100

Item 15. Exhibits and Financial Statement Schedules
100

Item 16.
Form 10-K Summary
102

Signatures
103

Invisalign, Align, the Invisalign logo, ClinCheck, Invisalign Assist, Invisalign First, Invisalign Go, the Invisalign sonic logo, Vivera, SmartForce, SmartTrack, SmartStage, SmileView, iTero, iTero Element, iTero Lumina, Orthocad, exocad, Align Digital Platform, Align Oral Health Suite, Invisalign Smile Architect, iTero exocad Connector, exocad Dental CAD, and Cubicure, among others, are trademarks and/or service marks of Align Technology, Inc. or one of its subsidiaries or affiliated companies and may be registered in the United States and/or other countries.

2

In addition to historical information, this Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements include, among other things, our expectations and intentions regarding our strategic objectives and the means to achieve them, our beliefs and expectations regarding macroeconomic conditions, including fluctuations in foreign currency exchange rates, inflation, higher interest rates, market volatility, actual or proposed tariffs, customs duties or fees, and any retaliatory tariffs or protectionist trade measures taken in response to such tariffs, actual or potential economic slowdowns or recessions, effects of geopolitical events, our expectations and beliefs regarding customer and consumer purchasing behavior and changes in consumer spending habits, our expectations regarding product mix, product launches, product pilots and product adoption, our expectations regarding competition and our ability to compete in our target markets, our expectations regarding the sales growth of our intraoral scanners, clear aligners and other products, our expectations regarding the impact of the military conflicts in the Middle East and Ukraine and our operations and assets in Israel and Russia, our marketing and efforts to build our brand awareness, our estimates regarding the size and opportunities of the markets we are targeting along with our expectations for growth in those markets and potential collaboration opportunities, our beliefs regarding the impact of technological innovation in general, and in our solutions and products in particular, on target markets and patient care, our beliefs regarding digital dentistry and its potential to impact our business, our intentions regarding expanding our business, including its impact on our operational flexibility and responsiveness to customer demand, our expectations regarding our tax positions and the judgments we make related to our tax obligations, our beliefs regarding the importance of our manufacturing operations on our success, our beliefs regarding the need for and benefits of our technological development on Invisalign treatment, the areas of development in which we focus our efforts, and the advantages of our intellectual property portfolio, our beliefs regarding our business strategy and growth drivers, our expectations regarding the utilization rates for our products, including the impact of marketing on those rates and causes for periodic fluctuations of the rates, our expectations regarding the existence and impact of seasonality, our expectations regarding the continued expansion of our international markets and their growth, our expectations regarding impacts or staying in compliance with laws and regulations currently applicable to, or which may become applicable to, our business both in the United States and internationally, our beliefs regarding our culture and commitment and its impact on our financial and operational performance and its importance to our future success, our expectations for future investments in and benefits from sales and marketing activities, our preparedness and our customers’ preparedness to react to changing circumstances and demand, our expectations for our expenses and capital obligations and expenditures in particular, our intentions to control spending and for investments, our intentions regarding the investment of and ability to repatriate foreign earnings, our belief regarding the sufficiency of our cash and investment balances and borrowing capacity, our judgments regarding the estimates used in our revenue recognition and assessment of goodwill and intangible assets, our predicted level of operating expenses and gross margins and other factors beyond our control, as well as other statements regarding our future operations, financial condition and prospects and business strategies.

In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” and similar expressions intended to identify forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in particular, the risks discussed below in Part I, Item 1A “Risk Factors.” We undertake no obligation to revise or update these forward-looking statements. Given these risks and uncertainties, you should not to place undue reliance on such forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this filing.

PART I
 

Item 1. Business.

Our Company

Align Technology, Inc. (“we,” “us,” “our,” “Align” or the “Company”) is a global medical device company primarily engaged in the design, manufacture and marketing of Invisalign ® clear aligners for the treatment of malocclusions, or the misalignment of teeth, by orthodontists and general dental practitioners (“GPs”), Vivera TM retainers for retention, iTero TM intraoral scanners and services for dentistry, and exocad TM computer-aided design and computer-aided manufacturing (“CAD/CAM”) software for dental laboratories and dental practitioners. Our vision and strategy is to revolutionize orthodontic and restorative dentistry through digital treatment planning and implementation using the Align TM Digital Platform, an integrated suite of proprietary technologies and services designed to deliver a seamless, end-to-end solution for patients, consumers, orthodontists, GPs and lab partners. We strive to achieve our vision and strategy through key objectives made possible with the proprietary technologies and services of the Align TM Digital Platform to establish: clear aligners as the principal solution for the treatment of malocclusions with the Invisalign System as the treatment solution of choice by orthodontists, GPs and patients
3

globally, our iTero intraoral scanners as the preferred scanning technology for digital dental scans and our exocad CAD/CAM software as the dental restorative solution of choice for dental labs.

Our corporate headquarters are located at 410 North Scottsdale Road, Suite 1300, Tempe, Arizona 85288. Our telephone number is 602-742-2000. Our internet address is www.aligntech.com . Our Americas regional headquarters is located in Raleigh, North Carolina, U.S.A.; our European, Middle East and Africa (“EMEA”) regional headquarters is located in Rotkreuz, Switzerland; and our Asia Pacific (“APAC”) regional headquarters is located in Singapore.

We have two operating segments: (1) Clear Aligner and (2) Imaging Systems and CAD/CAM Services (“Systems and Services”). For the year ended December 31, 2025, Clear Aligner net revenues represented approximately 80% of worldwide net revenues, while Systems and Services net revenues represented the remaining 20%. We sell the majority of our products and services directly through a dedicated and specialized sales force to our customers: orthodontists, GPs, including prosthodontists, periodontists, oral surgeons and dental laboratories. We also sell through sales agents and distributors in certain countries. In addition, we sell directly to dental support organizations (“DSOs”) who contract with dental practices to provide critical business management and support, including non-clinical operations. We also sell our products to dental laboratories who use our products to manufacture or customize their own products for licensed dentists. We furthermore market and sell doctor and consumer accessory products complementary to our doctor-prescribed principal products under the Invisalign ® and other brand names, including retainers, dental supplies, clear aligner cases (clamshells), ultrasonic and UV electronic cleaning devices, teeth whitening products and cleaning solutions (collectively, “Invisalign Accessory Products”). Depending on the product, our Invisalign Accessory Products are sold through a variety of channels, including online through large e-commerce websites, our doctor portal and in-store through large retailers and pharmacy stores.

Our clear aligners are sold under the Invisalign ® brand name. Our Invisalign System is intended mainly for the treatment of malocclusions and is designed to help dental professionals achieve the clinical outcomes they expect and the results patients desire. To date, over 22 million people worldwide have been treated with the Invisalign System. In order to provide Invisalign treatment to their patients, orthodontists and GPs must initially complete an Invisalign training course. Our iTero intraoral scanners are used by dental professionals, labs, and service providers for restorative and orthodontic digital procedures, Invisalign case submissions, and comprehensive digital dentistry diagnosis, treatment planning and treatment monitoring. Our exocad CAD/CAM software products provide restorative dentistry, implantology, guided surgery and smile design to dental labs and dental practices through fully integrated workflows, with the goal to provide cross-disciplinary dentistry in labs and at chairside.

Our Products, Services and Technologies

Align TM Digital Platform

For nearly 30 years, Align has been transforming smiles and changing lives; driving innovation in digital orthodontics and dentistry, helping doctors transform their practices using digital tools and technology to deliver exceptional, modern treatment
4

experiences and outcomes to over 22 million people worldwide. The Align TM Digital Platform is the foundation of our goal to lead the digital revolution in orthodontics, restorative dentistry and comprehensive digital dentistry by delivering seamless workflows in dental practices, on mobile devices, and through remote monitoring, as well as diagnostic and treatment solutions designed to improve all aspects of assessment and treatment, from initial consultations to final smiles with our doctor-centered treatment model.

The Align TM Digital Platform is an end-to-end digital platform that combines software, systems and services designed to provide a seamless experience and end-to-end workflow that integrates and connects those critical to successful treatment outcomes – doctors, labs, patients and consumers. At the center of the Align TM Digital Platform are Invisalign clear aligners, iTero intraoral scanners and exocad CAD/CAM software.

The Align TM Digital Platform utilizes the Align TM Digital Workflow to enable an end-to-end digital treatment experience and generate interconnected workflows and treatment solutions. The Align TM Digital Workflow includes dedicated tools and capabilities for each stage of the Invisalign treatment journey:

• Connect: The initial stage of the platform drives consumer demand and connects potential patients to our websites and the websites of Invisalign providers. Some of the tools that support this stage are Invisalign.com, Invisalign ® Doctor Locator, Invisalign SmileView TM tool, Invisalign ® Practice App, Invisalign ® Virtual Appointment and My Invisalign TM app.
• Scan: During this stage, patient data is captured through intraoral scanning. Doctors and their staffs use intraoral scanning tools designed to support diagnosis of a patient’s oral conditions and health and support doctors to develop appropriate treatment pathways. Visualization of their potential smiles helps patients understand the benefits of treatment and increases patient conversion. The tools that support this stage include iTero intraoral scanners and exocad CAD/CAM imaging systems, Invisalign ® Outcome Simulator Pro, iTero Element TM 5D auto-upload feature, iTero TM Near Infra-Red Imaging (NIRI) technology, iTero TM Scan Report, iTero TM TimeLapse Technology and iTero - exocad Connector TM .
• Diagnose : Doctors can access and use tools that support diagnosis of a patient’s oral health and develop an appropriate treatment pathway. The Align TM Digital Platform facilitates the doctor-patient conversation, through education regarding clinical needs and setting expectations. Some of the tools that support this stage include Align TM Oral Health Suite, Align X-ray Insights, iTero TM intraoral scanners, including those with NIRI technology, iTero TM TimeLapse technology and iTero TM Occlusogram.
• Plan: Doctors digitally visualize and plan orthodontic and restorative treatments. Orthodontists and GPs can use our products to design, build and share their vision for treatment planning and agree on a customized plan with their patients to reach the desired outcomes. Some of the tools that support this stage are ClinCheck® Pro Software, 3D Controls in ClinCheck® Pro, ClinCheck® Plan Editor, Invisalign® Personalized Plan, CBCT integration for ClinCheck®, and Invisalign Smile Architect™.
5

• Treat: During this stage, doctors treat their patients with our Invisalign ® clear aligners and may offer teeth whitening using the Invisalign TM Professional Whitening System. The Invisalign ® Palatal Expander System and the Invisalign ® System with mandibular advancement with occlusal blocks and enhanced precision wings, and SmartTrack™ material, SmartForce™ features and SmartStage™ technology are additional products that support patient treatment.
• Monitor: Doctors can remotely track their patients’ treatment between visits, and orthodontists and GPs can more easily track treatment progress and communicate issues, results and recommendations to their patients. Some of the tools that support this stage include Invisalign ® Progress Assessment, Invisalign ® Virtual Care AI and My Invisalign TM app.
• Retain: Following completion of their orthodontic treatment, patients can retain the final position of their teeth using Vivera TM retainers.

New Products/Feature Enhancement

As we further evolve the treatment planning experience for doctors through new technological research and development innovations, we expect to introduce new technologies, features and functionality that improve personalization of treatment planning, predictability, clinical preferences, and 2D/3D imaging, including digital tools for faster and more accurate final tooth positions.

In 2025, we announced several new enhancements to the Align TM Digital Platform.

• In March 2025, we announced the addition of restorative capabilities to our iTero Lumina™ intraoral scanner (without iTero NIRI technology) and the new iTero Lumina™ Pro dental imaging system (with iTero NIRI technology).

• In March 2025, we also announced the launch in European Union countries and the United Kingdom of Align X-ray Insights, a new software-based (CADe*) computer aided detection solution that uses artificial intelligence (“AI”) to automatically analyze 2D radiographs.

• In October 2025, we announced a series of new innovations for iTero Digital Solutions, a comprehensive ecosystem that includes intraoral scanners and integrated software tools, including enhancements to the Align™ Oral Health Suite, Invisalign ® Outcome Simulator Pro with ClinCheck ® Smile Video, and the iTero™ Design Suite.

• In December 2025, we announced limited commercial availability of the Invisalign ® System with mandibular advancement featuring occlusal blocks (“MAOB”), the latest clinical innovation that expands Align’s Class II treatment portfolio by offering practitioners a comprehensive solution for treating growing patients with Class II malocclusions caused by mandibular retrusion.

Clear Aligner Segment

Malocclusion and Traditional Orthodontic Treatment

Malocclusion is one of the most prevalent clinical dental conditions in the world, affecting approximately 60% to 75% of the global population. We estimate that there are approximately 600 million people globally with malocclusion who could benefit from straightening their teeth. However, most people afflicted by malocclusion do not seek orthodontic treatment for various reasons, including negative perceptions of traditional wires and brackets, affordability of treatment, and accessibility to doctors. Annually, only approximately 22 million people globally elect treatment by orthodontists. Today, most orthodontic patients continue to have their malocclusions treated with the use of traditional corrective methods such as metal arch wires and brackets, referred to as braces, augmented with elastics, metal expanders, headgear or functional appliances, and other ancillary devices as needed. Upon completion of a patient’s treatment, their dental professional may recommend the patient use a retainer appliance to preserve the benefits of their treatment. Of the 22 million cases started each year, we estimate that almost all can be treated using our Invisalign System, yet we estimate our share of the 22 million case starts through orthodontists is approximately 10% globally. Our business strategy remains focused on increasing our share of the existing market of orthodontic case starts compared to wires and brackets, especially among teens, and expand the market for digital orthodontics, especially among adults. By training more doctors, including GPs as well as orthodontists, increasing utilization of existing doctors using our products, educating more consumers about the benefits of straighter teeth using the Invisalign System and connecting consumers with an Invisalign-trained doctor of their choice, we are helping drive adoption of digital orthodontics and restorative dentistry globally.

The Invisalign System

6

The Invisalign System is a proprietary method for treating malocclusion based on a proprietary computer-simulated virtual treatment plan and a series of doctor-prescribed, custom manufactured, clear polymer removable aligners. We received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market the Invisalign System in 1998.

The Invisalign System offers a range of treatment options, specialized services and access to proprietary software for treatment visualization and is comprised of the following phases:

Diagnosis and transmission of treatment data . As part of the Align™ Digital Workflow, we have developed solutions to enable doctor diagnosis and drive patient adoption – providing tools to support diagnosis of a patient’s oral health and support to identify an appropriate treatment pathway, facilitating the doctor-patient conversation, education and clinical needs and expectations. An Invisalign trained dental professional prepares an online prescription form on our Invisalign Doctor Site and securely submits the patient’s records, which include a digital intraoral scan or a polyvinyl-siloxane (“PVS”) impression of the relevant dental arches, photographs of the patient and, at the dental professional’s election, x-rays of the patient’s dentition. Intraoral digital scans may be submitted through Align’s iTero scanner or certain third-party scanners capable of accurately interfacing with our systems and processes. Globally, more than 95% of Invisalign System prescription orders are now submitted via digital scan, increasing the accuracy of treatment plans, reducing the time from when the doctor submits the prescription to the time the patient receives the clear aligners, and helping to decrease the carbon footprint resulting from elimination of the initial or upfront shipment of the patient’s PVS impressions to the doctors and shipping those PVS impressions back to us.

Computer-simulated treatment plan . Our ClinCheck ® treatment planning software is the cornerstone of the Align TM Digital Platform. ClinCheck Pro treatment planning software uses proprietary algorithms based on the insights from data from our over 22 million patients treated worldwide. Using the digital scans or PVS impressions, certain doctor preferences and digital data provided, we generate a proposed custom, three-dimensional treatment plan, called a ClinCheck ® treatment plan, using proprietary software developed through significant, ongoing research and development investments spanning more than two decades. A patient’s ClinCheck treatment plan simulates desired tooth movement in stages and details the timing and placement of any features or attachments to be used during treatment. Attachments are tooth-colored shapes that are sometimes used to increase the biomechanical force on a specific tooth or teeth in order to affect the desired movement(s).

Review and approval of the treatment plan by an Invisalign-trained doctor. The patient’s ClinCheck treatment plan is then made available to the prescribing dental professional via our Invisalign Doctor Site, enabling the dental professional to evaluate projected tooth movement from initial to final position and compare, modify or choose from multiple treatment plan options to best meet the dental professional’s treatment objectives. By reviewing, modifying as needed and approving the treatment plan, the dental professional retains control of the patient’s treatment.

Manufacture of custom clear aligners. Following the dental professional’s approval of a ClinCheck treatment plan, we use the data underlying the simulation as input for stereolithography technology (a form of 3D printing technology) to construct a series of molds. Each mold is a replica of the patient’s teeth at each stage of the simulated course of treatment. From these molds, clear aligners are fabricated by pressure-forming polymeric sheets over each mold. Clear aligners are thin, clear polymer, removable dental appliances that are custom manufactured in a series designed to correspond to each stage of the patient’s ClinCheck treatment plan.

Shipment to the dental professional and patient clear aligner wear. Once manufactured, all the clear aligners for a patient’s doctor-approved treatment plan are typically shipped directly to the dental professional. The majority of doctors then dispense all of the clear aligners to the patient. Clear aligners are generally worn for one week or for a short period of time corresponding to the stages of the patient’s approved ClinCheck treatment plan and their doctor’s discretion. The patient replaces their current set of clear aligners with the next set in the series when prescribed, advancing tooth movement through each stage. At various points in each patient’s treatment, their doctor may place attachments or use other auxiliaries to achieve desired tooth movements, per the doctor’s original prescription and the approved ClinCheck treatment plan.

Clear Aligner Products

We offer our Invisalign System in a variety of treatment packages designed to correspond with the case-by-case treatment needs of our doctors and their patients and any nonclinical requirements. The table below provides a general description of the categories of products in our Invisalign System offered in various regions as they typically correspond to the severity of malocclusion and length of anticipated treatment.

7

Malocclusion Very Mild to Mild
Mild to Moderate
Moderate to Severe

Product Invisalign ® Express Package
Invisalign ® Lite Package
Invisalign Go
Package
Limited Movement
(GP)
Invisalign ® Moderate Package
Invisalign ® Comprehensive Packages

Treatment Stages* 7 14 20 20-26 As many as required
Clinical Scope Relapse and minor movement, anterior esthetic alignment Class I, mild crowding/spacing, non-extraction, pre-restorative
Class I, no AP correction, mild to moderate crowding/spacing, non-extraction, pre-restorative.

Tooth movement from second pre-molar to second pre-molar (5x5)
Class I, mild Class II, mild to moderate crowding/spacing, mild AP and vertical discrepancies, pre-restorative
Class I, II, III, moderate to severe crowding/spacing, AP and vertical discrepancies, extractions, complex pre-restorative

* The number of stages can vary by product and region.

Most of our Invisalign System products described above provide dental professionals with the option to order additional clear aligners if the patient’s treatment progress or needs deviate from the original treatment plan. The number and timing of additional clear aligner orders are subject to certain requirements noted in our terms and conditions. In certain regions, we offer streamlined configurations with limited or no additional aligners, including the option to separately purchase additional aligners under applicable terms, and we anticipate offering these configurations in additional markets over time.

Comprehensive Products - Invisalign Treatment Options

Invisalign Comprehensive Packages . Invisalign Comprehensive Packages are used to treat adults and teens over a wide spectrum of mild to severe malocclusion and contains a broad variety of features to achieve desired treatment goals. They also address the frequently complex orthodontic needs of teenage or younger patients with advanced features such as mandibular advancement, compliance indicators and compensation for tooth eruption. These packages include Invisalign Comprehensive, Invisalign First TM Phase 1 and Invisalign First TM Comprehensive Phase 2. 

Invisalign First Phase 1 and Invisalign First Comprehensive Phase 2 Packages . Invisalign First Phase 1 Package is designed specifically for younger patients generally between the ages of six and ten, who frequently have a mixture of primary/baby and permanent teeth. Invisalign First Phase 1 treatment provides early interceptive orthodontic treatment, traditionally done through arch expansion, or partial metal braces, before all permanent teeth have erupted. Invisalign First Phase 1 clear aligners are designed specifically to address a wide range of younger patients’ malocclusions, including shorter clinical crowns, management of erupting dentition and predictable dental arch expansion. Our Invisalign First Comprehensive Phase 2 Package complements Invisalign First Phase 1 and is generally consistent with our Invisalign Comprehensive Package. After a patient completes Invisalign First Phase 1, doctors have the option to purchase a Comprehensive Phase 2 Package for that same patient.

Invisalign Comprehensive 3in3 Package . The 3in3 configuration offers doctors Invisalign Comprehensive treatment with a three-year treatment expiration date and three sets of additional clear aligners included prior to the treatment expiration date, rather than the five-year treatment expiration date with unlimited additional clear aligner sets prior to the treatment end date offered under the Invisalign Comprehensive Package.

Invisalign ® System With Mandibular Advancement Featuring Occlusal Blocks for Class II Skeletal and Dental Correction. The Invisalign System with mandibular advancement featuring occlusal blocks expands our Class II treatment portfolio by offering practitioners a comprehensive solution for treating growing patients with late mixed or early permanent dentition (ages 10-16) with Class II malocclusions caused by mandibular retrusion. Class II malocclusion is one of the most common orthodontic problems, characterized by a discrepancy in jaw alignment where the lower jaw (mandible) is positioned too far back relative to the upper jaw (maxilla) and represents approximately 30%-45% of malocclusions globally. By leveraging the natural growth potential during pre-adolescence and adolescence, the Invisalign System with mandibular advancement featuring occlusal blocks facilitates effective correction of Class II malocclusions, helping to improve occlusal relationships, enhance facial aesthetics, and provides long-term functional benefits.

8

Non-Comprehensive Products - Invisalign Treatment Options

Invisalign Non-comprehensive Packages. We offer a variety of lower-priced treatment packages for less complex orthodontic cases, non-comprehensive relapse cases, or teeth straightening prior to restorative or cosmetic treatments, such as veneers. These treatment packages include Invisalign Express, Invisalign Lite, and Invisalign ® Moderate. These packages may be offered in select countries and/or may differ from region to region.

Invisalign Doctor Subscription Program (“DSP”) is our monthly subscription-based clear aligner program which includes retainers and low-stage “touch-up” clear aligner treatment. DSP is currently available in North America, Latin America, and certain countries in Europe.

Invisalign Go Packages. In various markets we also offer Invisalign Go TM , Invisalign Go TM Express and Invisalign Go TM Plus, which are streamlined non-comprehensive packages designed for GPs to more easily identify and treat patients with mild-to-moderate malocclusion cases, expand arch width, align anterior teeth prior to restorative treatment, and move teeth from second pre-molar to second pre-molar. These packages include case assessment support, simplified ClinCheck treatment plans and a progress assessment feature for case monitoring.

Invisalign® Palatal Expander System. In December 2023, we received 510(k) clearance in the United States for the Invisalign Palatal Expander System, a direct 3D printed orthodontic appliance design based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed, or permanent dentition during orthodontic or orthopedic treatment in children or adolescents. In adults, it is designed to be used in conjunction with surgery or other interventions when necessary. The Invisalign Palatal Expander System consists of a series of removable devices staged in small increments of movement to expand a patient’s narrow maxilla to a position determined by their treating doctor. Each direct 3D printed device is customized to the patient’s unique anatomy based on an iTero™ intraoral digital scan. A palatal expansion treatment plan and device design are then developed using our proprietary orthodontic software. The Invisalign Palatal Expander is our first direct 3D printed orthodontic device that provides doctors with a solution set to treat the most common skeletal and dental malocclusions in growing children. Together with Invisalign First™ clear aligners, Invisalign Palatal Expanders can address early intervention treatment, such as Phase 1, an early interceptive orthodontic treatment for young patients. The Invisalign Palatal Expander System is currently available in the United States, Canada, Australia, New Zealand, Hong Kong, Singapore, Vietnam, Japan, Thailand, India and certain countries in EMEA. The Invisalign Palatal Expander System is expected to be commercially available in additional markets, pending regulatory approvals.

Non-Case Products

The Comprehensive and Non-Comprehensive clear aligner packages described above are distributed in cases, meaning that all the sets of clear aligners required for all the stages of a doctor-approved treatment plan are delivered in a case. We also sell non-case products. Clear aligner non-case products include retention products, Invisalign training, adjusting tools used by dental professionals during the course of treatment, ancillary Invisalign Accessory Products and other oral health products available in certain e-commerce and retail channels in the United States.

Vivera™ Retainers for Retention . We offer up to four sets of Vivera retainers, which are custom clear aligners made with proprietary material strong enough to maintain tooth position and correct minor relapse, if necessary, as well as Invisalign retainers. Retainers are generally available for doctors to offer to any of their patients, whether they use the Invisalign System or other products, including wires and brackets. In select markets, we also offer single set retainers.

Invisalign Professional Whitening System. The Invisalign™ Professional Whitening System, powered by Opalescence™, is the only professional teeth whitening system approved by Align for combined use with Invisalign® aligners and Vivera™ retainers.

Direct Fabrication

In January 2024, we completed the acquisition of Cubicure GmbH (“Cubicure”), a company that develops, produces and distributes proprietary direct 3D printing technologies that enable us to efficiently and sustainably manufacture our devices without the added step of first creating a mold. We believe Cubicure provides direct fabrication capabilities that will support and scale our strategic innovation roadmap and strengthen the Align Digital Platform by enabling us to scale our 3D printing operations to eventually print millions of custom devices per day. We expect this technology will ultimately extend and scale our printing, materials and manufacturing capabilities for our 3D printed product portfolio while concurrently materially reducing the amount of resin used in our manufacturing process. Direct fabrication offers the transformative potential of design flexibility that goes beyond what the current thermoforming technology allows. This will potentially allow us to design unique appliances that may perform even better than existing appliances and address unmet market needs. We have begun limited
9

manufacturing of certain appliances already, and expect to pilot additional devices, including retainers and certain pre-fab attachments, in limited releases in 2026.

Smart Technology: SmartTrack TM , SmartForce TM and SmartStage TM

Smart technology is applied in the development of Invisalign treatments and leads to more precise control of individual and multiple tooth movements. We use a force driven system in our Invisalign clear aligners such that the next clear aligner is shaped so that when inserted, the clear aligner stretches and applies the desired force to the surface of the tooth, resulting in the desired tooth movement. Smart technology allows us to find the right thickness, the right elasticity, and the right force application over a period of time. Smart technology includes the use of SmartTrack, SmartForce and SmartStage Technology.

SmartTrack Material . SmartTrack clear aligner material is a patented, custom-engineered Invisalign clear aligner material that provides gentle, more constant force to improve control of tooth movements. Conventional clear aligner materials relax and lose a substantial percentage of the force applied in the initial days of wear. SmartTrack material maintains more constant force over a longer period of time. The flexible SmartTrack material also more precisely conforms to tooth morphology, attachments and interproximal spaces to improve control of tooth movement throughout treatment.

SmartForce Attachments . SmartForce attachments are small tooth-colored shapes that attach to teeth before or during Invisalign treatment. Invisalign clear aligners fit smoothly and tightly around the attachments and give the clear aligners something to gently push on. SmartForce attachments make complex tooth movements possible without braces by helping clear aligners apply the right amount of force in the right direction.

SmartStage Technology . SmartStage is an advanced algorithm that determines the optimal path of tooth movement and the shape of the clear aligner at every stage of an Invisalign treatment. The programming determines tooth movement in a certain sequence, at the right time to achieve optimal outcomes with greater predictability and fewer undesirable interferences.

Systems and Services Segment

Intraoral scanning is a rapidly evolving technology substantially impacting the practice of dentistry. By enabling the dental practitioner to create a 3D image (digital scan) of a patient’s teeth using a handheld intraoral scanner, digital scanning is faster, more efficient, precise and comfortable for patients. Beginning patient care with the early use of our iTero intraoral scanners and combining the results with digital workflows designed to assist doctors and patients visualize and evaluate various treatment options with detailed imagery and CAD/CAM solutions helps patients decide to undergo treatment and improve treatment outcomes and satisfaction. The accuracy of digitally scanned models substantially reduces the rate of restoration “remakes,” which results in patients being recalled to dental offices less often and experiencing shorter treatment times for the restoration work because fewer procedures are required after teeth are aligned and spaced optimally, increasing overall patient satisfaction. Digital models also reduce the carbon footprint associated with the shipping of the materials used to create PVS impressions, the shipping of those impressions and their disposal. Moreover, the digital model file can be used for various procedures and services including fabrication of physical dental models for use by labs to create restorative units such as veneers, inlays, onlays, crowns, bridges and implant abutments; digital records storage; aid to caries detection; orthodontic diagnosis; orthodontic retainers and appliances; and Invisalign ® digital impression submission.

iTero Element™ Scanner. The iTero Element™ portfolio of intraoral scanners includes the iTero Element™ 2, the iTero Element™ Flex, iTero Element™ 5D imaging system, iTero Element™ Plus Series and the iTero Lumina™ which are each available in select regions and countries. These products build on the existing high precision, full-color imaging and fast scan times of the iTero Element portfolio and are available with software options for orthodontic and restorative procedures. The iTero scanner is interoperable with our Invisalign system such that a full arch or full mouth digital scan can be submitted as part of the Invisalign system prescription order submission process.

Our iTero Element 5D imaging system is the first integrated dental imaging system that simultaneously records 3D, intraoral color camera images, NIRI technology and enables comparison over time using the iTero™ TimeLapse technology. NIRI technology, included in our iTero Element 5D and 5D Plus imaging systems, aids in detection and monitoring of interproximal caries above the gingiva in real time, without using harmful radiation. The iTero Element 5D imaging system is available in the United States, Canada, China, and the majority of EMEA and select APAC and LATAM countries and is pending regulatory approval in others. The findings of a clinical study we sponsored were published in the peer-reviewed Journal of Dentistry which demonstrated that the NIRI technology of the iTero Element 5D imaging system was 66% more sensitive than bitewing x-ray radiography for detection of interproximal lesions, without the use of harmful radiation. We received 510(k) clearance in the United States for the caries detection feature of the iTero Element 5D imaging system in 2020. The iTero Element Plus Series of intraoral scanners and imaging systems offers restorative and orthodontic digital workflows that include enhanced visualization for optimized patient experience, including a fully integrated 3D intraoral camera in certain
10

models, seamless scanning with reduced processing time, artificial intelligence (“AI”)-based features, and, in certain models, NIRI technology.

Our iTero Element scanners are offered in a number of software configurations such as Ortho Comprehensive, Restorative Comprehensive and Restorative Foundation. These software packages are included in the price of the scanner and have a service period of 1 to 5 years. They enable various orthodontic and restorative workflows as well as provide other applications, including Invisalign ® Outcome Simulator, Invisalign Case Assessment tool, Invisalign Progress Assessment tool, and iTero TimeLapse technology. Our iTero software is designed for orthodontists for digital records storage, orthodontic diagnosis, and for the fabrication of printed models and retainers. Our restorative software is designed for GPs, prosthodontists, periodontists and oral surgeons and includes restorative workflows providing the ability to send digital impressions to the lab of their choice and communicate seamlessly with external treatment planning, custom implant abutment, chairside milling and laboratory CAD/CAM systems such as through our iTero-exocad Connector TM .

Invisalign® Progress Assessment Tool. The Invisalign Progress Assessment tool provides the ability to compare a patient’s new scan with a specific stage of their ClinCheck ® treatment plan, allowing doctors to visually assess and communicate Invisalign treatment progress with an easy-to-read, color-coded, tooth movement report.

iTero TM TimeLapse Technology . Our iTero TM TimeLapse technology allows doctors or practitioners to compare a patient’s historic 3D scans to the present-day scan, enabling clinicians to identify and measure orthodontic movement, tooth wear, and gingival recession. This highlights areas of diagnostic interest to dental professionals and helps foster a proactive conversation with the patient regarding potential restorative or orthodontic solutions.

iTero Lumina™ Intraoral Scanner and iTero Lumina™ Pro Dental Imaging System

In January 2024, we launched the iTero Lumina intraoral scanner. The iTero Lumina intraoral scanner is designed with iTero Multi-Direct Capture TM technology that captures more data quickly and accurately while delivering exceptional scan quality and photorealistic images that remove the need for intraoral photos. iTero Multi-Direct Capture replaces the confocal imaging technology in earlier intraoral scanner models. It has a wider field of capture and multi-angled scanning that enables simultaneous capture from multiple angles. Additionally, the iTero Lumina scanner has a capture distance of up to 25mm, making it easier to scan complex oral regions such as narrow or deep palates, edentulous spaces, and partially erupted teeth with minimal maneuvering. It has a 50% smaller and 45% lighter wand (as compared to iTero Element™ 5D imaging system wand, excluding the wand cable), which is expected to be especially beneficial for kids and teen patients. The iTero Lumina scanner has photorealistic scans that are clinically comparable to intra-oral photography and its advanced software enables scanning at two times the speed.

In March 2025, we announced the addition of restorative capabilities to our next generation iTero Lumina™ intraoral scanner (without iTero NIRI technology) and the new iTero Lumina™ Pro dental imaging system (with NIRI technology) to enable efficient restorative and multidisciplinary ortho-restorative workflows and support diagnostic of interproximal caries above the gingiva, helping GPs reach new levels of practice efficiency and growth while delivering exceptional clinical outcomes.

Since October 2025, our portfolio of intraoral scanners have included a PC configuration (desktop and laptop) that extends the performance found in the cart and mobile configurations into a compact and adaptable format that integrates easily into existing practices.

The enhanced capabilities of the iTero Lumina solutions provide an improved scanning experience and performance, optimal for the simplest to the most challenging restorative cases. These capabilities are complemented by simplified restorative workflows that include the capture of single unit dental crowns to full dental arch with multiple preparations in a single pass, with a wave of an iTero Lumina wand.

iTero™ Digital Solutions

In October 2025, we announced a series of new product innovations for iTero™ Digital Solutions, a comprehensive ecosystem that includes intraoral scanners and integrated software tools designed to transform dental consultations into a modern, multi-modal oral health assessment that helps doctors and their teams deliver exceptional chairside experiences. These new capabilities span across key practice workflows that underline the Align™ Digital Workflow including Diagnose, Plan, Treat, and Monitor steps. From dynamic and personalized visualization and patient engagement tools at chairside, to expanded compatibility with 3D printers and milling machines, these new innovations are designed to simplify workflows, increase patient acceptance, and drive practice growth.

11

Align TM Oral Health Suite . The Align™ Oral Health Suite is designed to be an intuitive and visually engaging digital interface intended to enhance patient-driven interest and engagement with iTero Element™ Plus and iTero Lumina™ scan images to help drive doctor-patient conversations about treatment options earlier in the patient journey. The all-in-one chairside consultation can help patients see their oral health conditions, discuss potential root causes with their doctors and evaluate treatment options.

Invisalign® Outcome Simulator Pro . Invisalign Outcome Simulator Pro is a patient communication tool on iTero Element™ Plus Series and iTero Lumina™ imaging systems, that generates highly realistic, simulated in-face visualizations of a patient’s potential future smile after an orthodontic or ortho-restorative treatment. Invisalign Outcome Simulation Pro with multi treatment simulations offers two types of simulations chairside: Invisalign for ortho-only, and Invisalign Smile Architect™ for ortho-restorative. The new Invisalign ® Outcome Simulator Pro with Smile Video offers dynamic in-face visualization at chairside designed to improve patient conversion.

iTero™ Design Suite . iTero™ Design Suite offers doctors and dental staff a simple and intuitive digital chairside design workflow for 3D printing and milling of models, bite splints, mock-ups, and restorations to enable single-visit dentistry and better patient experiences. It includes comprehensive printing and milling compatibility, a new mock-up workflow that drives patient engagement and treatment acceptance, and the integration of iTero NIRI and HD intraoral images into the Suite to help trace the margin line and support detailed restoration design.

CAD/CAM Service s. Our exocad CAD/CAM software platform addresses restorative needs in an end-to-end digital platform workflow to facilitate ortho-restorative and comprehensive dentistry. The platform provides doctors and dental labs with digital clinical solutions that aid GPs and dental labs in planning and delivering restorative dental treatments, adding restorative functionality to our comprehensive digital platform to deliver digital ortho-restorative workflows and interdisciplinary dentistry. Our exocad software is licensed and sold separately.

Other proprietary software mentioned in this Annual Report on Form 10-K, such as software embedded in our iTero intraoral scanners, ClinCheck and ClinCheck Pro software, the Invisalign Doctor Site, Align X-Ray Insights and feature enhancements included as part of the Invisalign System are not sold separately, nor do they contribute as individual items to revenues.

Business Strategy

Over the past 28 years, Align has helped doctors treat over 22 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align TM Digital Platform. Our technology and innovations are designed to meet the demands of today’s patients with advanced technologies improving doctors’ diagnostic capabilities along with treatment options that are effective, convenient, comfortable and affordable to improve overall oral health. We strive to help doctors and lab technicians move their businesses forward by connecting them with new patients, providing digital solutions that increase operational speed and efficiency and provide solutions that allow them to deliver exceptional treatment outcomes and experiences to millions of people around the world. We achieve this by focusing on and executing our strategic growth drivers:

• International Expansion. We continue growing our global presence by increasing awareness of our products and making them available in more countries to more customers and consumers. We continue expansion of our sales and marketing by reaching into new countries and regions, including new areas in Africa, Asia and Latin America. As of the end of 2025, we are selling directly or through authorized distributors in more than 100 countries. We support our growth through targeted investments in clinical support, product improvements, technological innovations, clinical education and advertising. In addition, we are scaling and expanding our operations and facilities to better support the growing numbers of global customers. As of the end of 2025, we have 11 fabrication and treatment planning locations throughout the world. We have a manufacturing facility in each of our three key regions: Americas (Mexico), APAC (China), and EMEA (Poland). Each of these facilities form the foundation of our manufacturing strategy, which continues to evolve to increase flexibility and optimize our capacity and cost structure. We also perform digital treatment planning and interpretation for restorative cases worldwide, including in Costa Rica, China, Germany, Spain, Poland, and Japan, among others. By establishing and expanding our key operational activities in locations closer to our customers, we are creating an infrastructure that allows us to be responsive to local and regional needs, while providing global operational flexibility and scale needed for variations in global and regional demand. We expect to continue expanding our business by investing in resources, infrastructure and initiatives that help drive Invisalign treatment growth, position our iTero intraoral scanners as the preferred scanning technology for digital dental scans, and establish our exocad CAD/CAM software as the solution of choice for dental labs in existing and new markets.

12

• GP Dentist Treatment . We strive to enable GPs, who treat the general patient population, to more easily identify potential cases they can treat with the Invisalign System, monitor patient progress or, if needed, help refer cases to orthodontists while providing high-quality restorative, orthodontic and dental hygiene care. We believe success with GPs can be achieved through doctor training and clinical education, by offering digital tools such as the iTero intraoral scanner and products like Invisalign Go™ treatment that address the distinctive needs of GP patients, all delivered by sales and marketing personnel specifically focused on the unique needs of this customer category. We encourage GPs to scan every patient with intraoral scanners as a means to diagnose and treat patients over time and as an opportunity to drive future demand for their services and the Invisalign System. DSOs represent a large and growing opportunity to help drive adoption of digital technology across the dental industry. We have well established relationships with many DSOs globally that recognize the benefits of digital workflows enabled by our portfolio of products and services that make up the Align TM Digital Platform, including increased practice efficiency and profitability, as well as delivering a better patient experience from shorter cycle times and customer proximity. We have and may continue to financially invest in or explore collaborations with key ecosystem partners, including DSOs, whose missions and visions align with our vision, strategy, business model and goals.

• Patient Demand. Our goal is to make the Invisalign brand a highly recognized name brand worldwide by creating awareness for Invisalign treatment among consumers and motivating the potential 600 million patients who can benefit from treatment of malocclusion to seek treatment using the Invisalign System. We accomplish this through an integrated consumer marketing strategy that includes television, media, social networking and event marketing and strategic alliances with professional sports teams, as well as educating patients on treatment options and directing them to high volume Invisalign trained doctors. To further drive consumer awareness, we continue to offer additional dental-related Invisalign Accessory Products under the Invisalign brand name available in certain e-commerce channels in the United States. The initial stage of the Align TM Digital Platform drives consumer demand and connects potential patients to our websites and the websites of Invisalign providers. Some of the tools that support this stage are Invisalign.com, Doctor Locator, Invisalign SmileView TM tool, Invisalign ® Practice App, Invisalign ® Virtual Appointment and My Invisalign TM app. The Align TM Digital Platform also facilitates the doctor-patient conversation, through education regarding clinical needs and setting expectations. Further to our commitment to diagnostic innovation and our ongoing efforts to expand our digital platform, we launched the Align™ Oral Health Suite in 2025, which integrates iTero diagnostic aid and visualization tools, and broadens the holistic approach we offer to GP dentists and orthodontists to support earlier patient interaction for diverse treatment options in oral health, restorative and aesthetic dentistry.

• Orthodontic Utilization. We continue to innovate and increase product applicability and predictability to address a wide range of cases, from simple to complex, thereby enabling doctors to confidently diagnose and treat children and adults with the Invisalign System. This is especially important to treating teenage patients who make up the largest portion of the 22 million annual orthodontic case starts. We also continue to make improvements to our Invisalign treatment software, ClinCheck Pro, designed to deliver an exceptional user experience and increase treatment control to help doctors achieve their treatment goals. In combination with the new Invisalign System innovations that are part of the Align TM Digital Platform, we are enhancing the digital treatment planning experience for orthodontics by providing doctors with greater flexibility, consistency of treatment preferences and real-time treatment plan access and modification capabilities.

Manufacturing and Suppliers

We have regional fabrication facilities in our main markets for clear aligners, which are located in Juarez, Mexico; Ziyang, China; and Wroclaw, Poland. We believe this allows us to better serve our global customer base by being closer to our customers and driving efficiencies in the business. We produce our handheld intraoral scanner wand, perform final scanner assembly and repair our scanners at our facilities in Ziyang, China and Petah Tikva, Israel and also perform final scanner assembly in Blonie, Poland and Juarez, Mexico; as well as service and repair certain scanners in Juarez, Mexico.

We also perform digital treatment planning and interpretation for restorative cases based on digital scans generated by our iTero intraoral scanners. Our digital treatment planning facilities are located worldwide, including in Costa Rica, China, Germany, Spain, Poland and Japan, among other international locations.

Our quality system is required to be in compliance with the Quality System regulations enforced by the FDA, and similar regulations of other worldwide regulatory authorities. We are certified to ISO 13485:2016, an internationally recognized standard for medical device quality. We are routinely audited by third-party certification bodies as well as global health authorities for compliance to this standard and other international regulations. We maintain a formal, documented quality system by which quality objectives are defined, understood and achieved. Systems, processes and procedures are implemented to ensure high levels of product and service quality. We monitor the effectiveness of the quality system based on internal data
13

and direct customer feedback and strive to continually improve our systems and processes, taking corrective action, as needed.

Since the mass-customized treatment planning and manufacturing processes of our products require substantial and varied technical expertise, we believe our manufacturing capacity and capabilities are important to our success. In order to produce our highly-customized, highly-precise, medical quality products in volume, we have developed a number of proprietary processes and technologies. These include complex software algorithms and solutions, including AI and machine-learning based CAD/CAM software, vision systems, CT scanning, stereolithography and automated custom clear aligner fabrication equipment. To increase the efficiency and yield of our manufacturing processes, we continue to focus our efforts on software development, equipment development and the improvement of rate-limiting processes or bottlenecks. In addition, we have invested in developing technologies that allow us to directly print the devices to improve and streamline the processes as well as the performance of devices. We continuously upgrade our proprietary, three-dimensional treatment planning software to enhance computer analysis of treatment data and reduce time spent on manual and judgmental tasks for each case, thereby increasing the efficiency of our technicians. Moreover, to improve efficiency and increase the scale of our operations, we continue to invest in the development of automated systems for the fabrication and packaging of clear aligners.

In addition, predictable and consistent production is essential to timely deliver products to our customers efficiently and profitably. Our production can be disrupted by such things as supply chain and shipping issues, production manufacturing software system issues, quality and safety issues, and production equipment downtime. Accordingly, as we have grown our operations, we have included flexibility and resiliency in our overall manufacturing design to mitigate against risks of production downtime. Our manufacturing facilities include backup generators and systems and each facility has an emergency response plan that is part of ongoing employee training and testing through recurring cross functional scenario-based simulation exercises. Likewise, having manufacturing facilities in key regions provides greater flexibility and capacity to adjust and redirect production as needed.

As part of our manufacturing resiliency design efforts, we have also considered climate change related risks such as higher average global temperatures, rising sea levels and more frequent and severe wildfires, hurricanes, floods, storms, heat waves and other events and natural disasters (collectively, “climate-related risks”). We view climate-related risks to be one of many operational challenges we face and factor them into our business continuity planning and strategic risk mitigation efforts.

For instance, our manufacturing plants and operations may be impacted by extreme temperatures and weather, subjecting us to potential brownouts and blackouts, increased energy costs and capital investments needed to maintain ideal operating temperatures. Our manufacturing facility in Juarez, Mexico is located in an area classified as high-water stress and our operations could be impacted by water shortages, rationing and droughts. Our California, Costa Rica, Mexico and North Carolina operations are located in areas that have historically been impacted by extreme weather events such as hurricanes, tornados, wildfires or flooding.

In part to help mitigate risks to our manufacturing operations, we have strategically located our clear aligner production facilities on three different continents. This allows us to both respond more quickly to customer demand while also offering redundancy in the event natural disasters or climate-related events affect operations at one or more facilities. Moreover, each of our key clear aligner manufacturing facilities are located at elevations less likely to be impacted by rising sea levels and at least two hundred miles inland.

Moreover, we are highly dependent on manufacturers of specialized scanning equipment, rapid prototyping machines, resin and other advanced materials for our clear aligners, as well as the optics, electronic and other mechanical components of our intraoral scanners. We maintain single or sole source supplier relationships for many of these machines and materials technologies. In particular, our CT scanning and stereolithography equipment used in our clear aligner manufacturing and many of the critical components for the optics of our intraoral scanners are provided by single or sole source suppliers. We also currently purchase our resin and polymer, the primary raw materials used in our manufacturing process for clear aligners, from a single source. A discussion of the risks of our supply and manufacturing operations, including foreign operations, may be found in Item 1A of this Annual Report on Form 10-K under the heading “ Risk Factors .”

Sales and Marketing

Our sales and marketing efforts are focused on increasing adoption and utilization of the Invisalign System and Vivera retainers by orthodontists and GPs and integrating the iTero scanner and services and exocad CAD/CAM products into dental labs and practices. The iTero scanner is an important component to the customer experience and is central to a digital approach as well as overall customer utilization of Invisalign clear aligners. In each region, we have direct sales, marketing and support organizations, which include quota carrying sales representatives, sales management and sales administration. We also have distribution partners in certain markets. Our sales and marketing personnel are organized primarily to support orthodontists and GPs, allowing highly trained and specialized personnel to serve each customer channel, thereby increasing our focus and
14

effectiveness on both. We continue to expand in existing markets through targeted investments in sales resources, professional marketing and education programs. Additionally, our consumer marketing programs are designed to create awareness and educate consumers on the benefits of Invisalign treatment and Vivera retainers, including where they can find trained doctors to provide treatment.

We provide training, marketing and clinical support to orthodontists and GPs. As of December 31, 2025, we had approximately 130,015 active Invisalign-trained doctors. We define doctors as active if they have submitted at least one Invisalign case in the prior 12-month period. To drive further adoption by additional doctors and increase utilization by existing doctors, we are, among other things, continuing to move key operations closer to our customers, simplifying our Advantage rebate program, launching new offerings, expanding our zero AA configuration, aligning our sales teams to market demographics, and deepening our commitment to consumer marketing.

Research and Development

We are committed to investing in world-class digital and clinical technology development, which we believe is critical to achieving our goal of establishing the Invisalign System as the standard method for treating malocclusion, our iTero intraoral scanners as the preferred scanning technology for digital dental scans, and our exocad CAD/CAM software as the solution of choice for dental labs.

Our research and development activities are directed toward developing digital technology innovations we believe will deliver our next generation of products and solutions as part of the Align TM Digital Platform. These activities range from accelerating product and clinical innovation, to developing treatment planning and manufacturing process improvements, to researching future technologies, products and software.

The treatment capabilities of the Invisalign System have been demonstrated by more than 800 peer-reviewed publications and various clinical case studies and articles have been published that highlight the clinical applicability of Invisalign treatment as a means to effectively treat a broad spectrum of malocclusions across permanent and mixed dentitions, including addressing malocclusions of severe complexity. Similarly, various studies have been published demonstrating the capabilities of our iTero Lumina solutions, including advanced features such as our NIRI technology, and we have conducted internal clinical validation research supporting the conclusion that iTero Lumina photorealistic scans are clinically comparable to intra-oral photography. We undertake pre-commercialization trials and testing of our technological improvements to our products and manufacturing process. In September 2025, we launched an enhanced clinical evidence webpage containing an expansive library of peer-reviewed clinical research publications and the Align Global Gallery™, a searchable database of more than 1,500 real-world Invisalign treatment cases by doctors from around the world. We furthermore fund research in the field of orthodontics and dentistry through initiatives such as our Annual Research Award Program, which was in its 16th year in 2025 and donations to the American Association of Orthodontists Foundation.

Intellectual Property

We believe our intellectual property portfolio represents a substantial business advantage. As of December 31, 2025, we had 1,137 active U.S. patents, 1,147 active foreign patents, and 1,070 pending global patent applications. Our active U.S. patents expire between 2026 and 2044. When patents expire, we lose the protection and competitive advantages they provide, which could negatively impact our operating results; however, as we continue to pursue new innovations, we seek intellectual property protection for new inventions and know-how through U.S. and foreign patent applications and non-disclosure agreements. We also seek to protect our software, documentation and other written materials under trade secret and copyright laws. We furthermore have a broad and diverse trademark portfolio that we use to highlight and protect universally recognized brands. Information regarding risks associated with our proprietary technology and our intellectual property rights may be found in Part I, Item 1A of this Annual Report on Form 10-K under the heading “Risk Factors.”

Seasonal Fluctuations

General economic conditions impact our business and financial results, and we have historically experienced seasonal trends within our two operating segments, customer channels and geographic locations we serve. Sales of the Invisalign System are often weaker in Europe, especially southern European countries during the summer months and seasonally higher in China during the third quarter. Similarly, other international holidays like Lunar New Year can impact our sales in APAC in the first quarter. In North America, summer is typically the busiest season for orthodontists that have a high percentage of adolescent and teenage patients as many parents start their children in treatment before the school year begins. Conversely, many GPs are on vacation during this time and therefore tend to start fewer cases. For our Systems and Services segment, capital equipment sales are often stronger in the fourth calendar quarter. However, many of these typical seasonal patterns have been impacted by changes in foreign exchange rates, military conflicts, inflation, trade policies and other macroeconomic challenges. It remains
15

unclear when or the extent to which these seasonal fluctuations will return to historical norms. Consequently, seasonal trends have and may continue to cause fluctuations in our quarterly results, including fluctuations in sequential revenue growth rates.

Competition

Our clear aligner products compete directly against traditional orthodontic treatments that use wires and brackets and increasingly against clear aligner products manufactured and distributed by various companies, both within and outside the United States. Although the number of competitors varies by segment, product, geography and customer, they include new and well-established regional competitors in certain foreign markets, as well as larger companies, divisions of larger companies or well-capitalized new entrants with substantial sales, marketing, research and financial capabilities at cost-effective rates. We also compete with direct-to-consumer (“DTC”) companies that provide clear aligners directly to consumers requiring little or no in-office care from doctors and also from doctors who manufacture retainers and custom clear aligners using 3D printing technology.

Additionally, we face competition in the rapidly evolving markets for intraoral scanners and software solutions, including CAD/CAM. The global intraoral scanner market is very dynamic with participants spanning from traditional dental conglomerates to companies dedicated primarily to scanner development and sales with new entrants playing larger roles. The iTero intraoral scanner also competes with traditional PVS impressions that doctors use for clear aligner therapy or other dental procedures, as well as other intraoral scanners. It also competes with traditional bite wing 2D dental x-rays for detecting interproximal caries. Information regarding risks associated with increased competition may be found in Part I, Item 1A of this Annual Report on Form 10-K under the heading “ Risk Factors .”

We believe we are well positioned to compete in the markets we target. We have thousands of dedicated, highly skilled sales force employees who are focused on key portions of our target markets that allow us to uniquely address customer needs and thereby enhance the customer experience. Our significant historical and ongoing investments in research and development and design around the movement of teeth, SmartTrack aligner materials and design, intraoral scanning, 3D manufacturing, global scale of manufacturing and treatment planning, strong brand name recognition, strong workforce, diversified and knowledgeable customer base, geographic expansion, reliable financial results, leading digital platform, technology and IP, next wave of innovation with direct 3D printing and innovations powered by AI enabling more personalized care, and regulatory clearance of our products are among a few of our key competitive factors that compare favorably with our competitors’ products and services.

Government Regulations

Many countries have established regulatory frameworks for commercialization of medical devices. As a designer, manufacturer, and marketer of medical devices, we are obligated to comply with the respective frameworks of these countries to obtain and maintain access to these global markets.

The frameworks often define requirements for marketing authorizations which vary by country. Failure to obtain appropriate marketing authorization and meet all local requirements, including specific quality and safety standards and new software and AI standards in any country in which we market our products, could cause commercial disruption and/or subject us to sanctions and fines. Delays in receipt of, or a failure to receive, such marketing authorizations, or the loss of any previously received authorizations, could have a material adverse effect on our business, financial condition and results of operations.

With regards to premarket authorization in the United States, many of our products are classified as medical devices under the U.S. Food, Drug, and Cosmetic Act (“FD&C Act”). The FD&C Act requires these products, when sold in the United States, to be safe and effective for their intended use and to comply with medical device regulations defined by the FDA. The regulatory framework depends on a set of written processes for ensuring consistent quality called a Quality Management System (“QMS”) coupled with a product marketing authorization which depends on the risk classification of the product. This regulatory framework is comparable to the framework established in the European Union (“EU”). Within the EU, our products are subject to the requirements defined by the Medical Device Regulation EU 2017/745 which replaced the Medical Device Directive 93/42/EEC with a final transition date of May 26, 2021. Similar market access regulations exist in Brazil, China, Japan and other countries. Our QMS is routinely audited by certification bodies as well as country regulators for compliance with applicable regulations. We believe we are in material compliance with all state, federal, and international regulatory requirements applicable to our products.

We are also subject to various laws around the world that govern interactions with our customers as healthcare professionals or government officials. The laws govern different interactions and may include: prohibiting improper influence of or payments to healthcare professionals, other decision makers or purchasers of medical devices and government officials;
16

setting out rules for when and how to engage healthcare professionals; marketing our products within the regulatory approval (e.g., on label) promotion, sale and marketing of our products and services; the importing and exporting of our products; the operation of our facilities and distribution of our products; and disclosure of payments to healthcare professionals and institutions. As we expand our operations, compliance with applicable laws in countries in which we sell and invest in new business models becomes more complex and the general trend is toward increasingly stringent oversight and enforcement.

Initiatives sponsored by government agencies, legislative bodies, and the private sector to limit the growth of healthcare expenses generally are ongoing in markets where we do business. It is not possible to predict whether these trends will impact our business or the potential cost containment measures on our future business.

Our customers are healthcare providers who may be reimbursed by state or federal funded programs such as Medicaid, a foreign national healthcare program, or private pay insurance, each of which may offer some degree of oversight. As a medical device manufacturer and seller, we are subject to transparency reporting laws (also known as sunshine laws) that in certain countries and U.S. states require us to report transfers of value to healthcare professionals that perform services or receive other items from us (e.g., meals, travel, branded promotional or educational items, or other benefits of value). Enforcement actions and associated efforts to respond or defend against enforcement actions can be expensive, and any resulting findings carry the risk of significant civil and criminal penalties.

In addition, we must comply with numerous laws and regulations addressing privacy, data protection, artificial intelligence, data governance and cybersecurity. We are subject to the European Union General Data Protection Regulation 2016/679 and any applicable national implementing laws (together, the “EU GDPR”), as well as the United Kingdom General Data Protection Regulation and the Data Protection Act 2018 (together, the “UK GDPR”). Collectively, these are referred to as the “GDPR.” The GDPR establishes broad data privacy requirements regarding our collection, processing, sharing, disclosure, transfer, and other uses of information relating to identifiable living individuals. These requirements include principles of accountability and the obligation to demonstrate compliance through the implementation of appropriate policies, procedures, training, and audits. Many of these laws and regulations do or will soon regulate or restrict cross-border data transfers, such as in the United States, the EU, Switzerland, Brazil, China, Vietnam, Japan, Korea, Australia, New Zealand, the Kingdom of Saudi Arabia, Hong Kong and other countries. Further, in the United States, we may be required to comply with laws and regulations addressing the collection, use, security and processing of protected health information and other information relating to individuals, including the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing rules. Additionally, many U.S. states maintain laws and regulations addressing privacy, data protection, data governance and cybersecurity. Like many other companies, we must work to ensure our global privacy program framework incorporates applicable requirements of new and modified laws and regulations in relevant jurisdictions to support our efforts to ensure our product innovations and associated practices comply with these increasingly complex laws and regulations.

Legislatures and regulators globally are proposing, and in certain cases have enacted, new laws or regulations regarding privacy, data protection, artificial intelligence, data governance and cybersecurity that could require us to modify our policies and practices in order to comply with new and evolving obligations relating to these matters. Information regarding risks associated with data security and privacy may be found in Part I, Item 1A of this Annual Report on Form 10-K under the heading “ Risk Factors .”

Environmental Laws and Regulations

We are subject to numerous international, federal, state and local environmental laws, including provisions that regulate the purchase, use, distribution, and environmental impact of hazardous substances used in our operations, contained within our products and the packaging associated with our products. We are also subject to environmental laws applicable to our manufacturing facilities and operations, including environmental health, safety and sustainability regulations. The number and rate at which these regulations are being proposed and implemented are increasing at the regional, country and local territorial levels, requiring greater diligence, governance and skills to manage. We may be required to incur significant costs to comply with existing and new laws and regulations in the future. Information regarding risks associated with environmental laws and regulations may be found in Part I, Item 1A of this Annual Report on Form 10-K under the heading “ Risk Factors .”

Human Capital

We believe our culture and commitment to employees provide unique value that benefits Align, its stockholders and the communities and other stakeholders we serve. Every employee, and every job, is important to our success and helps us achieve our purpose of transforming smiles and changing lives. Align is committed to building a global workforce with varied cultural backgrounds and life experiences. Fostering a culture of dignity, integrity, open dialogue, open-mindedness, compassion,
17

fairness, recognition, and shared goals allows us to attract and retain the best talent, and provide a safe and supportive environment that allows our employees to excel.

As of December 31, 2025, we had approximately 20,290 employees, a decrease of approximately 3.1% and 6.1% over December 31, 2024, and December 31, 2023, respectively. The number of employees for each of the last five years and our employees’ roles as of December 31, 2025 are as follows:

We are fundamentally a global organization with approximately 91% of our employees located internationally, primarily in direct-labor roles in our manufacturing and clinical treatment planning facilities. Set forth in the following paragraphs are some of the most important elements of our culture and commitment to our employees.

Governance . Our commitment to improving the lives of our employees and the communities in which we live and work, including conducting our business ethically, responsibly and transparently through open and clear disclosures that allow us and others to hold us accountable, begins with our Board of Directors (“Board”) and management team. They set the tone for our organization by establishing and clearly communicating our core values of Agility, Customer and Accountability that inform our culture. Our Global Code of Conduct (“Code”) and quality policies are designed to enable us to operate with integrity and deliver superior treatment outcomes and experiences to patients. We seek to create an environment that values the health, safety and well-being of our teams, and we work to equip them with the knowledge and skills to serve our business and develop their careers. We believe that by effectively managing our business founded on these values, we are driving long-term value for our stockholders and all stakeholders.

As part of our commitment to our employees and communities, our Board has delegated oversight responsibility of our policies and practices that foster Align’s sustainability and cultural initiatives, policies, practices, and programs to our Nominating and Governance Committee. Additionally, our Compensation and Human Capital Committee has oversight responsibilities of all human capital management strategies, programs and policies. Our Compensation and Human Capital Committee regularly reviews and discusses key performance indicators regarding human capital management that allow it to monitor trends on issues such as total headcount, employee hiring, recruiting, attrition, career development, compensation, benefits, workplace culture, and other measures of employee engagement and interest to management and the committee.

We believe our success continues to be driven by our focus on integrating and welcoming employees across the globe and of all different backgrounds, orientations, beliefs, perspectives and capabilities into our workforce. Our employees bring a positive mix of ethnic and culturally diverse backgrounds to the 48 different countries in which we operate. Our largest population of employees work in Mexico followed by Costa Rica and China. Employees in the United States represent approximately 9% of our global population.

18

Our management team is comprised of individuals from varying countries and nationalities who are committed to promoting and encouraging the health and well-being of our employees at work, at home and in society in general.

Our work culture is designed to create financial, health, career and personal benefits for our employees and organization. We sponsor cultural recognition events to increase awareness of inclusion and belonging, including its importance in creating an environment where every employee feels safe, supported and can thrive.

Our employees have also established and manage employee groups including employee resource groups based on shared characteristics or life experiences. These are open to all employees, including those who do not directly identify with other members.

Talent Recruitment and Engagement. W e employ a variety of career development, employee benefits, compensation and other policies and programs designed to attract, develop and retain employees. We focus on building a talent pipeline that nurtures those early in their careers, encourages continuous learning and growth, and incentivizes employees to stay and contribute to our success over the long term. Our programs include early recruitment at high schools and universities, initiatives such as internships, co-ops, apprenticeships, and training programs, quarterly performance management check-ins focused on individual goals and commitment to values and conducting regular employee surveys to build trust and strengthen relationships.

Our efforts have resulted in numerous awards for our positive work environment and culture. Some of the certifications, awards and recognitions recognized or received include:

• Best Workplaces for Women, China
• Best Workplaces for Parents, Korea
• Great Places to Work and Best Places to Work based on our employee-validated great workplaces in the following countries: Australia, Brazil, Canada, China, India, Israel, Korea, Singapore, Taiwan, Thailand, Turkey, Vietnam and Raleigh, North Carolina (United States)
• Forbes America’s Best Employers: Dream Employers, Best Midsize Employers, Best Employers for Engineers, Best Employers for New Grads, Best Employers for Company Culture
• LinkedIn Top Companies, Israel
• Mercer China, Healthiest Workplace Award for Outstanding Women Care
• Newsweek, America’s Greatest Workplaces: Overall, By State (California), Gen Z, Inclusion, Mental Well-Being, Parents & Families

We believe it is imperative to provide a vibrant employee experience and we value our employees’ collective voices. Accordingly, we conduct recurring employee surveys that utilize a continuous employee listening strategy to collect employee feedback critical to improving our culture. This includes globally managed pulse surveys, employee lifecycle surveys, and a self-service feature to support listening efforts. We use what we learn from the surveys to improve the employee experience, including enhancements to our workplaces, focus on employee connections, increased career development opportunities, support for relocated employees, and growth in our recognition programs and experiences. Our global response rates are consistently high, reflecting strong engagement by our employees.

Training and Professional Development . Training is an integral part of developing and retaining our employees and creating a culture of leadership within Align.

19

Training at Align begins with our Code and our strong commitment to ethical business practices in all aspects of our operations. Every employee and contractor is required to review the Code and confirm they understand and will comply with it. We routinely reference the Code in presentations and as part of everyday operations.

As a further part of our standard onboarding program, we train employees on important environmental health and safety topics to protect them and the environment. As a general practice, employees are trained to perform their jobs in accordance with all applicable statutory and regulatory requirements and that training is routinely refreshed and re-administered.

At Align, we believe employees learn best when skill development is driven by the changing and immediate needs of our employees and by empowering all employees to take action and ownership of their careers. We also believe learning should be relevant and actionable as well as rooted in our purpose and values. develop@Align, our global online learning hub, enables our global employee population to access a diverse portfolio of approximately 2,100 self-directed courses in up to 23 languages. We also offer a full suite of custom leadership development programs, beginning with aspiring leaders, continuing with managers and directors, and culminating with executive development opportunities.

We also recognize we must continually evolve by providing employees with the resources they need to continue to learn, grow, and thrive. To this end, we created Voyage. Voyage is a global initiative that offers a set of tools, resources and a new mindset, empowering employees to start thinking differently about career growth by embracing development opportunities in new and sometimes unexpected ways. Our Voyage Compass helps employees experience their career through four distinct lenses: self, networks, experience and skills. Since its launch in 2022, over 70% of the employee population has interacted with Voyage, and there have been over 164,000 visits to the Voyage website. In addition to our navigation site, we annually host a Voyage Set Sail Month, where we offer experiential learning for individuals and teams utilizing activities that keep professional development front and center in employees’ minds.

Compensation and Benefits . Our benefit and compensation programs reflect the value and contributions our employees make. In addition to competitive base pay, we offer an assortment of benefits that vary by country, roles and contributions, including performance-based variable compensation programs, health and welfare benefit plans, retirement planning services and benefits, holiday and leave policies, equity participation programs such as our 2005 Annual Incentive Plan and Employee Stock Purchase Plan, and charitable and community service opportunities. We also offer discounts to our employees and their dependents who undergo Invisalign treatment.

We are furthermore committed to pay equity practices. We exceed minimum pay requirements for our manufacturing employees and regularly review our pay equity practices globally and locally for compliance with applicable laws and work to address discrepancies identified.

Health, Wellness and Safety . Our employees’ health and well-being is critical to our success and their continuing achievements. We therefore offer a wide variety of robust programs and initiatives designed to promote the overall health and welfare of all our employees and their families. Every year, we promote a Month of Wellness, a month dedicated to well-being and a worldwide movement fostering employee health across our organization. Throughout the Month of Wellness, employees participate in a variety of activities such as informational sessions and health fairs and receive useful resources aligned to our wellness pillars - mental resilience, physical well-being and healthy living, social/family connections, and financial wellness. This provides employees with a variety of meaningful ways to embrace wellness and well-being through mindfulness, meditation, nutrition and mental wellness activities, exercise, hikes, yoga, volunteer activities, financial education sessions, social events and stress management.

Additionally, a primary objective is to prevent injuries and occupational diseases by focusing first and foremost on creating and maintaining safe environments. We have e nvironmental, health, safety and sustainability personnel who are responsible for ensuring health and safety programs and processes are maintained and effective at each of our locations. Major worksites, such as our clear aligner fabrication sites, and large offices have dedicated Environmental Health and Safety (“EHS”) departments dedicated to ensuring our health and safety programs are maintained while contributing Best Management Practices and general input to corporate-wide programs. Each EHS department is responsible for ensuring all employees at their location are properly trained on various EHS topics and at the appropriate frequencies. A training suite is determined for each employee depending on their responsibilities and function modeled off ISO 45001.

Community. We actively encourage employees to support charitable organizations by providing opportunities for volunteerism, team building, and donation and matching programs. In 2025 , our employees continued to make us proud through their generosity and dedication, especially during our annual Month of Smiles initiative in October where we encouraged them to make a difference individually and as teams through volunteer activities, charitable donations, fundraising, and intentional acts of goodness. In addition, through our Align Foundation, we support organizations whose visions closely align with our
20

mission to improve smiles, supporting and educating teens, and empowering our customers through partnerships with learning institutions and foundations. Below are some of our key community initiatives in 2025 :

• Since 2013, we have been a proud supporter of Operation Smile, a global medical nonprofit that has provided hundreds of thousands of free surgeries for people born with cleft lips and cleft palates in low and middle-income countries. For a fifth year, we were the title sponsor of Operation Smile’s International Student Leadership Conference, a powerful opportunity for youth in high schools and colleges around the world to develop leadership skills and impact their communities. As part of our 2025 sponsorship, we provided scholarships for 90 students, including those born with cleft conditions and those facing financial barriers. As of December 31, 2025, we had donated approximately $3.4 million to Operation Smile.

• As part of Align’s commitment to improving oral health, we partnered with the INCAE Business School as part of the CAHI Jeffe Fellowship in Health and Innovation to improve health services in Latin America. The CAHI Jeffe Fellowship brought together 19 leaders from nine Latin American countries and focused on enhancing the quality, accessibility, and affordability of health services through a variety of programs. Align provided scholarships to two leaders from the program who focused on oral health education and expansion of dental health for low-income populations.

• For 18 years we have supported America’s ToothFairy, an organization with a mission to ensure underserved children in the United States have access to dental care and learn about oral health by supporting nonprofit clinics and community partners. As of December 31, 2025, we have provided almost $2 million for the foundation’s operational expenses and children’s oral health programs. As Title Sponsor of the HERO Program since 2019, we have helped the program reach an estimated 2.87 million children, caregivers, and parents. During America’s ToothFairy’s 2025 fiscal year, which ended June 30th, the HERO Program positively impacted 1,082,150 children and caregivers using downloadable resources, which are also available in multiple languages. With Align’s support, America’s ToothFairy’s Dental Resource Program (DRP) member clinics provided clinical care to 213,675 children—on average, a 25% increase over 2024. Among these:

◦ 191,204 children received fluoride varnish, nearly 36% more than in 2024
◦ 75% of patients served live at or below the poverty line
◦ 44% of children treated live in rural communities where access to care is limited
◦ 52% of care was delivered through school-based programs
◦ 85% of patients rely on state-funded insurance

We also provide product donations to the dental community to help patients in need of healthy, beautiful smiles. For more information on our charitable and community efforts, please refer to the Corporate Accountability portion of our corporate website located at https://www.aligntech.com/about/corporate_accountability .

Available Information

Our corporate website address is www.aligntech.com , and our investor relations website address is http://investor.aligntech.com . The information on or accessible through either of these websites is not incorporated by reference into this Annual Report on Form 10-K, and all website URLs in this Annual Report on Form 10-K are intended to be inactive textual references only. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, our proxy statements on Schedule 14A for our annual stockholders’ meetings and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Exchange Act are available, free of charge, on our investor relations website as soon as reasonably practicable after we electronically file with or furnish such material to the Securities and Exchange Commission (“SEC”). Further, the SEC maintains an internet site ( http://www.sec.gov) that contains reports, proxy and information statements and other information regarding our filings with the SEC.

21

Information about our Executive Officers

The following table sets forth certain information regarding our executive officers as of February 27, 2026:
 

Name Age Position Period
Joseph M. Hogan

68 President and Chief Executive Officer of Align
• Chief Executive Officer of ABB
• Chief Executive Officer of GE Healthcare
2015-Present
2008-2013
2000-2008
John F. Morici

59 Chief Financial Officer and Executive Vice President, Global Finance of Align
• Chief Financial Officer and Senior Vice President, Global Finance of Align
• Chief Financial Officer of Align
• EVP and Managing Director of NBC Universal North America Home Entertainment
• CFO/Chief Operating Officer of NBC Universal North America Home Entertainment
• Senior Vice President and Chief Financial Officer of NBC Universal North America Home Entertainment
2022-Present
2018-2022
2016-2018
2014-2016
2011-2014
2007-2011

Julie Coletti

58 Executive Vice President, Chief Legal and Regulatory Officer of Align
• Senior Vice President, Chief Legal and Regulatory Officer of Align
• Vice President, Associate General Counsel, Strategic Commercial Affairs of Align
• Vice President, Global General Counsel and Chief Compliance Officer of Danaher
• Vice President, Chief Legal Officer and Corporate Secretary of Bayer HealthCare's MEDRAD/Radiology and Interventional Division
2022-Present
2019-2022
2018-2019
2013-2017
2007-2013
Stuart Hockridge

54 Executive Vice President, Global Human Resources of Align
• Senior Vice Present, Global Human Resources of Align
• Vice President, Global Human Resources of Align
• Vice President of Talent of Visa
2022-Present
2018-2022
2016-2018
2013-2016

Item 1A. Risk Factors.

Our business, reputation, results of operations, financial condition, cash flows and stock price can be affected by a number of factors, whether currently known or unknown, or that we currently believe to be material. including those described below. When any one or more of these risks materialize from time to time, our business, reputation, results of operations, financial condition, cash flows and stock price can be materially and adversely affected. The risks below are not the only ones we face. Because of the following factors, as well as other factors affecting our results of operations and financial condition, past financial performance should not be considered to be a reliable indicator of future performance, and investors should not use historical trends to anticipate results or trends in future periods. Therefore, you should review this section carefully, as well as our consolidated financial statements and notes thereto and other information appearing in this Annual Report on Form 10-K, for important information regarding these and other risks that may affect us. Additionally, you should consider these risk factors in connection with evaluating the forward-looking statements contained in this Annual Report on Form 10-K.

Macroeconomic and External Risks

Global and regional economic conditions have and could in the future materially affect our business, financial condition and results of operations.

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. 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. 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. 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. Higher inflation, as well as the cost of fuel, energy and domestic and international shipping costs, food and other essential or discretionary items,
22

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. Attempts to offset cost increases with price increases may reduce sales, increase customer dissatisfaction or otherwise harm our reputation. Any of these events could materially affect our business, financial condition or results of operations.

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. Although the U.S. dollar is our reporting currency, a large portion of our net revenues and expenses are generated in foreign currencies. While we forecast our balance sheet exposures to foreign currency fluctuations and utilize foreign currency forward contracts to moderate the impact of currency fluctuations on certain assets and liabilities, these contracts may not eliminate our exposure. Currency exchange rate fluctuations have and may continue to materially adversely affect our results of operations and cash flows.

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 .

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.

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. Department of Commerce has initiated an investigation under Section 232 of the Trade Expansion Act of 1962, as amended, to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices. A significant portion of the products we sell, and the components and raw materials used in our products are originally manufactured or sourced outside the United States. 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. 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. 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.

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. Such actions may be expensive, time-consuming, disruptive to our logistics and operations, irreversible, and more costly for us and our customers. 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.

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. Our iTero operations, headquartered in Israel, are close to areas that have been affected by the conflict between Israel and Hamas. 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. Additionally, China’s territorial conflicts with other neighboring countries may impact our operations and sales in China. 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.

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.
23

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. 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

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. For example, Invisalign treatment is a significant departure from traditional orthodontic wires and brackets, and our customers and consumers may not find it cost-effective or preferable. A number of dental professionals believe Invisalign treatment is only appropriate for a limited percentage of patients. 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. 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. 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.

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.

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. Our ASPs for the Invisalign System and iTero intraoral scanners have been and could in the future be adversely affected if:

• we offer promotions or general or volume-based discount programs, product or services bundles, large account sales or consumer rebate programs;
• participation in promotions or programs unexpectedly increases, decreases or changes demand in material ways;
• our geographic, channel or product mix shifts to lower-priced products or to products with a higher percentage of deferred revenue;
• we decrease prices or are unable to increase prices on one or more products or services in response to increasing competitive pricing pressures;
• 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;
• we participate in government tenders, such as volume-based procurement in China; or
• our critical accounting estimates materially differ from actual results.

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.

Competition in the markets for our products and services is increasing.

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. 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
24

financial resources to develop or acquire new AI technologies and systems in the future and sufficiently meet evolving industry trends and consumer demands.

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. 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. 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. 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.

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 NIRI 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. 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.

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:

• 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;
• 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;
• allocate our research and development funding to products and services with higher growth prospects;
• ensure the compatibility of our technology, services and systems with those of our customers;
• anticipate and rapidly innovate in response to new competitive offerings and technologies;
• differentiate our products and services from those of our competitors as well as other products and services in our own portfolio and successfully articulate the benefits to potential customers;
• design and manufacture products that achieve the clinical and practice outcomes necessary for market acceptance;
• manage the impact of nationalism or initiatives encouraging consumer purchases from domestic vendors;
• qualify for third-party reimbursement for procedures involving our products or services;
• offer attractive and competitive products, services and subscription plans;
• encourage customers to adopt new or improved technologies and provide the needed technical, sales and marketing support to make new or improved product and services launches successful;
• manage government procurement program restrictions; and
• source and receive quality raw materials or parts from our suppliers.

If we fail to accurately predict the needs and preferences of customers and their patients, or fail to offer viable products or services, we may invest heavily in research and development that does not lead to significant revenues. Even if we successfully innovate and develop new or improved products and services, we may incur substantial costs doing so and our profitability may suffer. 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. 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.

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.

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. 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:

25

• 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;
• experience information technology (“IT”) security and privacy compliance issues;
• invest in companies that generate net losses or are slow or fail to develop;
• not realize a positive return on our investment or determine that investments have declined in value, which could require recording impairments;
• need to pay cash, incur debt or issue equity securities to pay for an acquisition, adversely affecting our liquidity, financial condition or the trading price of our common stock;
• find it difficult to implement and harmonize company-wide financial reporting, forecasting and budgeting, accounting, billing, IT and other systems due to inconsistencies in standards, internal controls, procedures and policies;
• require significant time and resources to effectuate the integration;
• fail to retain key personnel or harm our existing culture or the culture of an acquired entity;
• not realize material portions of the expected synergies and benefits of the investment or acquisition; or
• unsuccessfully evaluate or utilize the acquired technology or acquired company’s know-how or fail to successfully integrate the technologies acquired.

Operational Risks

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:

• changes in consumer, customer and industry demand;
• changes in manufacturing, packaging, delivery and inventory costs;
• the creditworthiness, liquidity and solvency of our customers and their ability to timely make payments when due;
• our ability to collect payments;
• our acceptance of longer customer payment cycles;
• 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;
• geographic, channel or product mix shifts to lower priced products or to products with a higher percentage of deferred revenue;
• improvements to or changes in our products, capabilities or technologies that replace or shorten the life cycles of legacy products or cause customers to defer or stop purchasing legacy products until new products become available;
• changes in costs and expenditures, including in connection with new treatment planning and fabrication facilities and the hiring and deployment of personnel;
• the timing of clear aligner treatment order submissions, acceptance, processing and fulfillment, which can cause fluctuations in our backlog;
• new, proposed or retaliatory tariffs; and
• timing and fluctuation of spending around marketing and brand awareness campaigns and industry trade shows.

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.

We may make business decisions that adversely affect our operating results such as modifications to our pricing policies and payment terms, promotions, development efforts, product releases, business structure or operations. The majority of our expenses, such as employee compensation and lease obligations, are relatively fixed in the short term. Moreover, our expense levels are based, in part, on expectations for future revenues. 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.

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.

DSOs, OSOs and other large group practices have become an increasingly important channel for adoption of our products and services. 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. 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.

26

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.

To manage current and anticipated future operations effectively, we must continually implement and improve our operational, financial and management information systems, hire, train, motivate, manage and retain employees, and ensure our suppliers remain diverse and capable of meeting demand for the systems, raw materials, parts and components essential to product manufacturing and delivery. We may fail to balance near-term efforts to meet existing demand with future demand, including adding personnel, creating scalable, secure and robust systems and operations, and automating processes for long-term efficiencies. Production of the Invisalign System and iTero intraoral scanners could also be limited by capacity constraints due to a variety of factors, including labor shortages, shipping delays, our dependency on third-party vendors for key materials, parts, components and equipment, the quality of or changes in product components, and limited production yields. Any such failure could materially impact our business, financial condition and results of operations.

Additionally, we have established treatment planning and manufacturing facilities closer to our international customers to provide better experiences, create efficiencies and provide redundancy should other facilities become unavailable. 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.

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.

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. 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. 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. We have experienced, and may again experience in the future, cybersecurity incidents, data incidents, and unauthorized internal employee exfiltration of information.

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. Further, the frequency and sophistication of third-party cybersecurity attacks are increasing, particularly with the advancement of AI technologies. 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. 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.

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. 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. 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. 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.

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. 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. Moreover, we continue to transform business processes, extend established processes to new subsidiaries, and implement additional functionality in our enterprise resource planning, product development, manufacturing, and other software and IT systems. This entails certain risks, including operational disruptions, such as our ability to continue developing and updating
27

products while addressing safety and security, track orders and timely ship products, manage our supply chain, and aggregate financial and operational data. 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. Software applications and products containing software may contain errors or defects, especially when first introduced or released. The discovery of a defect, error, or security vulnerability in our products, software applications or IT systems, incompatibility with customers’ computer operating systems and hardware configurations with a new release or upgraded version or the failure of our products or primary IT systems, that we are unable to timely cure, may cause adverse consequences. These may include delays, loss of revenues, significant remediation costs, market acceptance delays, data damage, loss, or unavailability, unintended disclosure or other processing of financial, health or other information relating to individuals, product recalls, loss of market share or increased service costs, any of which could have a material effect on our reputation, business, financial condition or results of our operations and those of our customers or our business partners.

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.

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. 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. We may not timely and adequately remediate or implement corrective measures for such failures, including due to reliance on third-party providers or suppliers. Consequently, any remediation may be time-consuming or difficult to achieve, which may materially impact our customers and business partners, damage our reputation, and result in lost business and revenue opportunities, and could be materially costly. If our products experience component aging, errors, or performance problems, or do not otherwise satisfy our stringent quality processes and controls we may choose to or be compelled to recall certain products, which may include, product withdrawals from the market, labeling changes, design changes, customer notifications, and notifications to global regulatory bodies.

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. 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.

We are highly dependent on third-party suppliers, some of whom are sole source suppliers, for certain key machines, components and materials, and our business, financial condition and results of operations could be materially adversely affected if supply is restricted or ends or the price materially increases.

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. 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.

Because of our dependence on our suppliers, changes in key relationships can materially disrupt our supply chain. For instance, we may be unable to quickly establish or qualify replacement suppliers, which could create production interruptions, delays and inefficiencies. Finding substitute manufacturers may be expensive, time-consuming or impossible and could result in significant interruptions in the supply of one or more products, product retesting or additional product registration, causing us to lose revenues and damage customer relationships. Technology changes by our service providers, vendors and other third parties could disrupt access to required manufacturing capacity or require expensive, time-consuming development efforts to adapt and integrate new equipment or processes. In the event of technology changes, delivery delays, labor stoppages or shortages, or increases in price for these items, sales may decrease and our business and prospects may be harmed.

We contract with commercial intermediaries to distribute a portion of the importation, marketing and sales of our products and services, which exposes us to risks to our sales, operations and reputation, including the risk these intermediaries do not comply with applicable laws or our internal procedures.

28

In addition to our direct sales force, we have and expect to continue to use distributors, resellers or other commercial intermediaries to import, market, sell, service and support our products and services. Our distribution agreements are generally non-exclusive and terminable by either party with customary notice. If qualified and acceptable alternative commercial intermediaries cannot be quickly found and trained in the use, marketing, sales and support of our products and services, our revenues and ability to sell or service our products and services in key markets could be adversely affected. These commercial intermediaries may also choose to sell alternative or competing products or services. In addition, we may be held responsible for the actions of these commercial intermediaries, their employees and commercial intermediaries for non-compliance with laws and regulations, including fair competition, bribery and corruption, import and export compliance, safety, data privacy, false advertising or unfair and deceptive trade practices, and marketing and sales activities. If these commercial intermediaries fail to satisfy customers, our reputation and brand loyalty could be harmed. An intermediary may also affect our ability to effectively market our products in certain foreign countries or regulatory jurisdictions if it holds the regulatory authorization in such countries or within such regions and causes, by action or inaction, the suspension of such marketing authorization or sanctions for non-compliance or prevents us from taking control of any such authorization. It may be difficult, expensive, and time-consuming for us to re-establish market access or regulatory compliance.

A disruption in the operations of a primary freight carrier, higher shipping costs or shipping delays could disrupt our supply chain and impact our operating and financial results.

We depend on commercial freight carriers, primarily United Parcel Service, Inc., to deliver our products. If the operations of commercial freight carriers are disrupted or we fail to mitigate any disruptions, we may be unable to timely deliver products to our customers who may choose alternative products, causing our net revenues and gross margin to decline, possibly materially. Moreover, when fuel costs increase, our freight costs generally do as well. 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. 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.

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.

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. 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. 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. 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.

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. 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. 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. 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. 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. Labor disputes and work stoppages involving our personnel may disrupt our operations and could materially impact our results or operations.

We depend on our marketing activities to deepen our market penetration and raise awareness of our brands, products, and services, which may prove unsuccessful or may become less effective or more costly to maintain in the long term.

Our marketing efforts and costs are significant and include national and regional campaigns in multiple countries involving television, film, print, social media and alliances with professional sports teams, athletes, social media influencers and other strategic partners. Our advertising campaigns may not achieve the desired returns on advertising spend, increase brand, product or services awareness sufficiently or generate goodwill and positive reputational goals among the teen and adult markets, enable us to maintain commercial relationships with social media influencers and other strategic partners, or differentiate our products from those featured in the growing number of advertising campaigns by competitors promoting similar products and messaging. Moreover, should any entity or individual endorsing us, our products or services take actions, make or publish statements in support of, or lend support to events or causes which are perceived by a portion of society negatively, our sponsorships or support of these entities or individuals may be questioned, our products and services boycotted and our brand image and
29

reputation harmed, any of which could materially affect our business, financial condition and results of operations. The harm of negative publicity, particularly on social media platforms, may be immediate, without affording us an opportunity for redress or correction.

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. Moreover, competitors do not always follow these restrictions, which can create an unfair advantage and make it more difficult and costly to compete.

Additionally, we rely heavily on data generated from our campaigns to target specific audiences and evaluate their effectiveness, particularly data generated from internet activities on mobile devices. To obtain this data, we are dependent on third parties and popular mobile operating systems, networks, technologies, products and standards we do not control, such as the Android and iOS operating systems, and mobile browsers. Changes in such systems that degrade or eliminate our ability to target or measure the results of ads or increase costs to target audiences could adversely affect our campaigns. Operating systems could also include data privacy settings that may limit our ability to interpret, target and measure ads effectively.

Legal, Regulatory and Compliance Risks

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.

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. 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. For more information, see Note 8 “ Legal Proceedings” of the Notes to Consolidated Financial Statements in Part II, Item 8 of this Annual Report on Form 10-K.

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. 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.