Company Performance - Align Technology reported quarterly earnings of $2.13 per share, exceeding the Zacks Consensus Estimate of $1.98 per share, but slightly down from $2.14 per share a year ago [1] - The earnings surprise for this quarter was 7.58%, following a previous quarter where the company also surpassed expectations with earnings of $2.44 per share against an estimate of $2.43 [2] - The company posted revenues of $979.26 million for the quarter, surpassing the Zacks Consensus Estimate by 0.67%, but down from $997.43 million in the same quarter last year [3] Stock Performance - Align Technology shares have declined approximately 14.8% since the beginning of the year, compared to a 5.5% decline in the S&P 500 [4] - The current Zacks Rank for Align Technology is 3 (Hold), indicating that the stock is expected to perform in line with the market in the near future [7] Future Outlook - The consensus EPS estimate for the upcoming quarter is $2.56 on revenues of $1.05 billion, and for the current fiscal year, it is $9.87 on revenues of $4.09 billion [8] - The outlook for the Medical - Dental Supplies industry, to which Align Technology belongs, is currently in the bottom 36% of over 250 Zacks industries, which may impact stock performance [9]

Q1 2025 Financial Performance - Total revenues reached $979.3 million, a decrease of 1.6% quarter-over-quarter and 1.8% year-over-year[31] - Clear Aligner revenues totaled $796.8 million, up 0.3% quarter-over-quarter but down 2.5% year-over-year[31] - Systems and Services revenues amounted to $182.4 million, down 9.2% quarter-over-quarter but up 1.2% year-over-year[31] - GAAP operating margin was 13.4%, a decrease of 1.1 percentage points quarter-over-quarter and 2.1 percentage points year-over-year[31] Clear Aligner Segment - Worldwide Clear Aligner shipments were 642.3K, an increase of 2.2% quarter-over-quarter and 6.2% year-over-year[33] - Clear Aligner average per case shipment price was $1,240, a decrease of $25 sequentially and $110 year-over-year[96] - Teen and Kids Clear Aligner shipments increased 4.5% quarter-over-quarter and 13.3% year-over-year, reaching approximately 226K[49] Systems and Services Segment - Systems and Services revenues increased 1.2% year-over-year[68] - CAD/CAM and Services revenues represent 49.8% of the Systems and Services business[70] Financial Outlook - The company expects Q2 2025 worldwide revenues to be in the range of $1.05 billion to $1.07 billion[125] - The company expects 2025 year-over-year revenue growth to be in the range of 3.5% to 5.5% at current spot rates[125]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $979.3 million, down 1.6% sequentially and down 1.8% year over year [18] - Q1 clear aligner revenues were $796.8 million, up 0.3% sequentially but down 2.5% year over year [18][20] - Q1 systems and services revenue was $182.4 million, down 9.2% sequentially but up 1.2% year over year [21] - Overall gross margin for Q1 was 69.5%, down 0.6 points sequentially and down 0.5 points year over year [22] - Q1 net income per diluted share was $1.27, down $0.13 sequentially and year over year [26][27] Business Line Data and Key Metrics Changes - Clear aligner volumes grew 6.2% year over year, with significant growth in the EMEA and APAC regions [6][7] - Systems and services revenues were slightly up year over year due to the adoption of the iTero Lumina scanner platform [6][21] - Q1 clear aligner average per case shipment price was $12.40, down $110 year over year due to product mix shifts and discounts [20] Market Data and Key Metrics Changes - North America saw a year-over-year increase in clear aligner volumes, driven by the adoption of Invisalign First and other products [7][9] - EMEA region volumes reflected strong demand across both orthodontic and GP channels [8] - APAC region growth was led by increased utilization in both ortho and GP channels across various markets [8] Company Strategy and Development Direction - The company is focused on innovation in orthodontics, including the launch of the Invisalign Pallet Expander and the iTero Lumina scanner with restorative capabilities [10][12] - Align Technology aims to enhance clinical outcomes and patient experiences through its digital platform and new product offerings [13][40] - The company is committed to expanding its market presence and improving operational efficiencies to drive growth [39][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the clear aligner business despite global economic uncertainties [39] - The company anticipates Q2 2025 revenues to be in the range of $1.05 billion to $1.07 billion, indicating sequential growth [36] - Management highlighted the importance of digital workflows and the role of dental service organizations (DSOs) in driving growth [13][39] Other Important Information - The company received a favorable ruling regarding VAT applicability in the UK, which could enhance patient access to oral health [30] - Align Technology is actively managing tariff impacts through strategic production locations and supply chain adjustments [33][34] Q&A Session Summary Question: Strength in the quarter despite consumer sentiment decline - Management noted good volume growth across regions, particularly in North America, and highlighted the positive impact of new product launches [46][48] Question: Plans to mitigate tariff impacts - Management indicated confidence in their current production locations and supply chain strategies to mitigate tariff impacts [51][53] Question: Insights for the upcoming investor day - Management plans to provide a comprehensive overview of the company's technology and commercial positioning [55][56] Question: Clarification on 2025 revenue guidance and ASPs - Management confirmed that ASPs are expected to remain under pressure due to product mix shifts, but overall revenue growth is anticipated [58][60] Question: Performance of the teen segment - Management highlighted strong growth in the teen segment, driven by new products and effective distribution strategies [62][64] Question: ASP impacts from VAT and FX - Management discussed the potential for ASP improvements if the VAT situation in the UK is resolved favorably and noted that FX could become a positive contributor going forward [71][75]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $979.3 million, down 1.6% sequentially and down 1.8% year over year [18] - Q1 clear aligner revenues were $796.8 million, up 0.3% sequentially but down 2.5% year over year [19] - Q1 systems and services revenue was $182.4 million, down 9.2% sequentially but up 1.2% year over year [20] - Overall gross margin for Q1 was 69.5%, down 0.6 points sequentially and down 0.5 points year over year [22] - Q1 net income per diluted share was $1.27, down $0.13 sequentially and year over year [26] Business Line Data and Key Metrics Changes - Clear aligner volumes grew 6.2% year over year, with significant growth in the EMEA and APAC regions, and North America [6] - Systems and services revenues were slightly up year over year due to the adoption of the iTero Lumina scanner platform [7] - Clear aligner average per case shipment price decreased to $12.40, down $110 year over year due to product mix shifts and discounts [19] Market Data and Key Metrics Changes - North America saw a year-over-year increase in clear aligner volumes, driven by the adoption of Invisalign First for teens and kids [7] - EMEA region volumes reflected strong demand across both orthodontic and GP channels [8] - APAC region growth was driven by increased utilization in both ortho and GP channels across various markets [9] Company Strategy and Development Direction - The company is focused on innovation in orthodontics, including the launch of the Invisalign Pallet Expander system and the iTero Lumina scanner with restorative capabilities [10][11] - Align Technology aims to enhance clinical outcomes and patient experiences through its digital platform and new product offerings [12] - The company is committed to expanding its market presence and improving practice efficiency through digital workflows [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the clear aligner business despite global economic uncertainties and potential headwinds from tariffs [40] - The company anticipates Q2 2025 revenues to be in the range of $1.05 billion to $1.07 billion, indicating sequential growth [36] - For fiscal 2025, Align expects clear aligner volume growth to be mid-single digits year over year, with systems and services revenues growing faster than clear aligner revenues [39] Other Important Information - The company received a favorable ruling regarding VAT applicability for clear aligner sales in the UK, which could enhance patient access to oral health [31] - Align Technology is actively managing its supply chain to mitigate potential tariff impacts, maintaining a strong global presence [34][35] Q&A Session Summary Question: Strength in the quarter despite consumer sentiment decline - Management noted good volume growth across regions, particularly in North America, APAC, and Europe, indicating a decoupling from consumer sentiment trends [46][48] Question: Plans to mitigate tariff impacts - Management stated they are well-positioned to handle tariff impacts through global supply lines and operational adjustments [50][52] Question: Insights for the upcoming investor day - Management indicated that the investor day will provide a comprehensive overview of the company's portfolio and future positioning [56] Question: Clarification on 2025 revenue guidance - Management confirmed that the revenue guidance reflects a slight adjustment in ASP expectations, with clear aligner volumes expected to grow mid-single digits [58][60] Question: ASP dynamics and impacts from VAT - Management explained that the VAT impact from the UK could provide flexibility in pricing, potentially benefiting ASPs if the appeal does not proceed [72][74]

[Executive Summary & Q1'25 Financial Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Q1%2725%20Financial%20Highlights) Align Technology reported Q1'25 revenues of $979.3 million, impacted by FX, with growth in Clear Aligner volume and key operational milestones [Q1'25 Key Financial Metrics](index=1&type=section&id=Q1%2725%20Key%20Financial%20Metrics) Align Technology reported Q1'25 total revenues of $979.3 million, a slight decrease year-over-year, significantly impacted by unfavorable foreign exchange. Clear Aligner volume showed growth, especially in teens and growing patients, while Clear Aligner revenues saw a slight year-over-year decline. Imaging Systems and CAD/CAM Services revenues increased year-over-year | Metric | Q1'25 Value | Sequential Change | Year-over-Year Change | | :-------------------------------- | :---------- | :---------------- | :-------------------- | | Total Revenues | $979.3M | -1.6% | -1.8% | | Clear Aligner Revenues | $796.8M | +0.3% | -2.5% | | Clear Aligner Volume | 642.3K cases | +2.2% | +6.2% | | Teen & Growing Patient Aligner Volume | 225.8K cases | +4.5% | +13.3% | | Imaging Systems & CAD/CAM Services Revenues | $182.4M | -9.2% | +1.2% | | GAAP Operating Income | $131.1M | - | - | | GAAP Operating Margin | 13.4% | - | - | | Non-GAAP Operating Margin | 19.1% | -4.1 pts | -0.7 pts | | GAAP Diluted EPS | $1.27 | -$0.13 | -$0.13 | | Non-GAAP Diluted EPS | $2.13 | -$0.31 | -$0.01 | | Cash and Cash Equivalents | $873.0M | -$170.9M | - | - Foreign exchange unfavorably impacted total revenues by approximately **$21.4 million** sequentially and **$31.1 million** year-over-year[2](index=2&type=chunk)[3](index=3&type=chunk) - Q1'25 marks the highest year-over-year growth rate for both adult and teen patients since 2021[3](index=3&type=chunk) [Operational Highlights & Milestones](index=2&type=section&id=Operational%20Highlights%20%26%20Milestones) Align Technology celebrated a significant milestone of 20 million Invisalign patients globally, reflecting strong doctor and consumer confidence. The company also noted increased Clear Aligner volumes in both orthodontic and GP dentist channels, with record utilization for GP dentists in Q1. The iTero Lumina scanner platform continued its adoption, with a new restorative software launch - Reached the **20 million** Invisalign patient 'smilestone', initiating a year-long celebration[3](index=3&type=chunk) - Q1 Clear Aligner volumes in orthodontic and GP dentist channels increased year-over-year, with record GP dentist utilization for a first quarter[3](index=3&type=chunk) - Continued adoption of the iTero™ Lumina scanner platform and launch of iTero Lumina with restorative software at the end of March[3](index=3&type=chunk) [Detailed Financial Performance (Q1'25)](index=3&type=section&id=Detailed%20Financial%20Performance%20(Q1%2725)) This section details Align Technology's Q1'25 financial performance, including revenue breakdown, profitability, and cash flow [Revenue Breakdown](index=3&type=section&id=Revenue%20Breakdown) Align Technology's Q1'25 net revenues were $979.3 million, a 1.6% sequential and 1.8% year-over-year decrease. Clear Aligner revenues were $796.8 million, showing a slight sequential increase but a 2.5% year-over-year decline. Imaging Systems and CAD/CAM Services revenues were $182.4 million, down sequentially but up 1.2% year-over-year | Metric | Q1'25 | Q4'24 | Q1'24 | Q/Q Change | Y/Y Change | | :-------------------------------- | :------ | :------ | :------ | :--------- | :--------- | | Net Revenues | $979.3M | $995.2M | $997.4M | (1.6)% | (1.8)% | | Clear Aligner Revenues | $796.8M | $794.3M | $817.3M | +0.3% | (2.5)% | | Imaging Systems and CAD/CAM Services | $182.4M | $200.9M | $180.2M | (9.2)% | +1.2% | - Clear Aligner shipments increased by **2.2%** sequentially to **642,305 cases** and by **6.2%** year-over-year[4](index=4&type=chunk) [Profitability and EPS](index=3&type=section&id=Profitability%20and%20EPS) GAAP net income for Q1'25 was $93.2 million, resulting in diluted EPS of $1.27, both down sequentially and year-over-year. Non-GAAP net income was $156.9 million, with diluted EPS of $2.13, also showing declines compared to prior periods | Metric | Q1'25 | Q4'24 | Q1'24 | Q/Q Change | Y/Y Change | | :---------------- | :------ | :------ | :------ | :--------- | :--------- | | GAAP Net Income | $93.2M | $103.8M | $105.0M | (10.2)% | (11.2)% | | GAAP Diluted EPS | $1.27 | $1.39 | $1.39 | ($0.13) | ($0.13) | | Non-GAAP Net Income | $156.9M | $181.6M | $161.4M | (13.6)% | (2.8)% | | Non-GAAP Diluted EPS | $2.13 | $2.44 | $2.14 | ($0.31) | ($0.01) | [Cash and Liquidity](index=3&type=section&id=Cash%20and%20Liquidity) As of March 31, 2025, Align Technology held $873.0 million in cash and cash equivalents, a decrease from $1,043.9 million at the end of Q4'24. The company also had $300.0 million available under its revolving line of credit | Metric | March 31, 2025 | December 31, 2024 | | :---------------------- | :------------- | :---------------- | | Cash and Cash Equivalents | $873.0 million | $1,043.9 million | - Available revolving line of credit: **$300.0 million** as of March 31, 2025[7](index=7&type=chunk) [Corporate and Strategic Updates](index=3&type=section&id=Corporate%20and%20Strategic%20Updates) Align Technology updated on product launches, stock repurchases, and regulatory and tariff developments [Recent Announcements and Product Launches](index=3&type=section&id=Recent%20Announcements%20and%20Product%20Launches) Align Technology made several key announcements, including an upcoming Investor Day, commercial availability of the Invisalign System with mandibular advancement in Australia and New Zealand, a partnership with Bay Football Club, and the launch of Align™ X-ray Insights, an AI-powered software for 2D radiograph analysis in Europe and the UK. Additionally, restorative capabilities were added to the iTero Lumina™ intraoral scanner, and the Invisalign Palatal Expander System was approved in Turkey - Investor Day scheduled for May 6, 2025[8](index=8&type=chunk) - Invisalign System with mandibular advancement commercially available in Australia and New Zealand[8](index=8&type=chunk) - Launched Align™ X-ray Insights in EU and UK, an AI-based solution for 2D radiograph analysis[8](index=8&type=chunk) - Added restorative capabilities to iTero Lumina™ intraoral scanner and launched iTero Lumina™ Pro for efficient ortho-restorative workflows[8](index=8&type=chunk) - Invisalign Palatal Expander System approved and commercially available in Turkey[8](index=8&type=chunk) [Stock Repurchase Program](index=4&type=section&id=Stock%20Repurchase%20Program) During Q1'25, Align Technology completed the remaining $72.1 million of a $275.0 million open market repurchase initiated in Q4'24. A new plan was initiated to repurchase the remaining $225.0 million under the January 2023 approved $1.0 billion stock repurchase program, with $129.0 million repurchased as of March 31, 2025 - Completed **$72.1 million** of the **$275.0 million** Q4'24 open market repurchase[12](index=12&type=chunk) - Initiated a new plan to repurchase the remaining **$225.0 million** under the **$1.0 billion** January 2023 Stock Repurchase Program[12](index=12&type=chunk) - Repurchased **$129.0 million** as of March 31, 2025, under the new plan[12](index=12&type=chunk) [Regulatory and Tariff Updates](index=4&type=section&id=Regulatory%20and%20Tariff%20Updates) Align Technology received a favorable UK VAT ruling, classifying Clear Aligners as 'dental prostheses' for VAT exemption. Regarding tariffs, USMCA compliant goods from Mexico are currently exempt from new US tariffs, but the situation remains fluid. For China, the company expects to mitigate most retaliatory tariff exposure through supply chain adjustments. Israeli goods imported into the U.S. face an estimated $1 million monthly impact from a 10% tariff, which has been factored into guidance - Received a favorable UK VAT ruling on April 24, 2025, determining Clear Aligners are 'dental prostheses' and thus exempt from VAT[12](index=12&type=chunk) - Clear Aligners and Intraoral Scanners made in Mexico and imported into the U.S. are compliant with USMCA and currently exempt from new tariffs, though the situation is fluid[12](index=

Market Opportunity and Product Adoption - Clear Aligner net revenues accounted for approximately 81% of worldwide net revenues for the year ended December 31, 2024[14]. - Over 19 million people worldwide have been treated with the Invisalign System, indicating strong market penetration[15]. - Approximately 600 million people globally suffer from malocclusion, with only about 22 million seeking orthodontic treatment annually, representing a significant market opportunity[20]. - The share of orthodontic case starts treated with the Invisalign System is approximately 10% globally, highlighting potential for growth[20]. - The company focuses on increasing the utilization of existing doctors and educating consumers about the benefits of the Invisalign System to drive adoption[20]. - The Invisalign System offers various treatment packages tailored to different levels of malocclusion severity, enhancing its market appeal[25]. - The company aims to create awareness for Invisalign treatment among the potential 600 million patients who can benefit from treatment of malocclusion[11]. - The company is focused on increasing adoption of the Invisalign System and Vivera retainers by orthodontists and general practitioners worldwide[60]. Product Innovations and Technology - In 2024, several new products and technologies were launched, including the iTero Lumina intraoral scanner and Invisalign Outcome Simulator with Multiple Treatment Simulation[18]. - Approximately 94% of prescription orders for the Invisalign System are now submitted via digital scan, improving accuracy and efficiency[21]. - The Align Digital Platform aims to enhance treatment personalization and predictability through ongoing technological innovations[18]. - The Align Digital Workflow integrates software, systems, and services to streamline the treatment process from diagnosis to retention[22]. - The company continues to innovate its Invisalign treatment software, ClinCheck Pro, to enhance user experience and treatment control[50]. - The company received 510(k) clearance for the Invisalign Palatal Expander System in December 2023, aimed at rapid expansion of the upper jaw for young patients[34]. - The acquisition of Cubicure GmbH in January 2024 is expected to enhance the company's 3D printing capabilities, allowing for the direct printing of millions of custom appliances daily[35]. - The iTero Element 5D Imaging System demonstrated 66% greater sensitivity in detecting interproximal lesions compared to traditional bitewing x-rays[43]. - The iTero Lumina intraoral scanner, launched in January 2024, features Multi-Direct Capture technology for improved data capture and scan quality[45]. - The Invisalign Outcome Simulator allows patients to visualize potential treatment results, enhancing patient engagement and acceptance[46]. - The SmartTrack material used in clear aligners maintains more constant force over time, improving control of tooth movements[38]. - The SmartStage Technology optimizes the path of tooth movement, enhancing treatment predictability and outcomes[40]. - The Align Oral Health Suite integrates various diagnostic tools into a single interface, improving the dental consultation experience[46]. Global Expansion and Workforce - The company is expanding its global presence, selling directly or through authorized distributors in over 100 countries by the end of 2024[11]. - As of December 31, 2024, there are approximately 130,370 active Invisalign-trained doctors, defined as those who have submitted at least one Invisalign case in the prior 12-month period[61]. - The company has established 13 fabrication and treatment planning locations worldwide, with manufacturing facilities in Mexico, China, and Poland[11]. - As of December 31, 2024, the company had approximately 20,945 employees, reflecting a decrease of 3.1% from December 31, 2023[79]. - Approximately 91% of the company's employees are located internationally, primarily in direct-labor roles in manufacturing and clinical treatment planning facilities[79]. Research, Development, and Compliance - The company has made significant investments in research and development, focusing on innovations such as SmartTrack aligner materials and AI-powered personalized care[68]. - The company is committed to compliance with various international, federal, and state regulations, including those related to medical devices and data protection[70][75]. - The company is subject to evolving antitrust and competition regulations, which could result in fines and operational changes that materially impact its business[152]. - Compliance with extensive and frequently changing regulations is critical, and failure to do so could result in penalties and harm to the company's reputation[153]. - The company faces significant time, effort, and expense to obtain and maintain regulatory clearances and approvals, with no guarantee of timely success in various markets[155]. - The company is subject to anti-corruption and anti-bribery laws, requiring accurate record-keeping and internal accounting controls to avoid liability[158]. - Compliance with privacy, data protection, and cybersecurity laws is critical, with potential significant penalties for noncompliance, including fines and legal actions[165]. Financial Performance and Market Risks - The company's net revenues are primarily dependent on sales of the Invisalign System and iTero intraoral scanners, with the Invisalign System expected to continue representing the majority of net revenues[115]. - The average selling prices (ASPs) of the Invisalign System and iTero scanners are influenced by factors such as product mix, geographical mix, and foreign currency exchange rates, which could adversely affect net revenues and gross profit[116]. - The company has a history of offering volume discounts and price reductions to stimulate demand, which may lead to reduced net revenues and gross margins[117]. - Competition in the dental industry is increasing, with new technologies and products emerging, potentially rendering existing products obsolete[118]. - The company faces diverse competition, including traditional orthodontic methods and new market entrants offering clear aligners with minimal in-office care[120]. - The company is exposed to fluctuations in foreign currencies, which may adversely impact its financial condition and results of operations[108]. - Macroeconomic conditions, including inflation and consumer confidence, can significantly affect demand for the company's products[105]. - The company faces risks from geopolitical events, tariffs, and trade disputes that could disrupt operations and impact financial performance[109]. Employee Engagement and Corporate Responsibility - The company has received numerous awards for its workplace culture, including recognition as one of the Best Places to Work in various countries[88]. - The company offers a diverse portfolio of approximately 1,800 self-directed courses in up to 80 languages to support employee development[92]. - The company emphasizes pay equity practices and regularly reviews compensation to address discrepancies[95]. - The company has implemented a global initiative called Voyage, which has seen over 45% employee interaction since its launch in 2022[93]. - The company is focused on enhancing the employee experience through regular surveys and feedback mechanisms, resulting in high engagement rates[89]. - The company donated approximately $3.0 million to Operation Smile as of December 31, 2024, supporting free surgeries for individuals with cleft conditions[101]. - The company has provided nearly $2 million to America's ToothFairy, impacting an estimated 2.7 million children since 2019[101]. - During the 2024 fiscal year, the HERO Program positively impacted over 900,000 children and caregivers, reaching more than 600,000 children with educational resources[101]. - The company partnered with INCAE Business School to improve health services in Latin America, providing scholarships to two leaders focused on oral health education[101]. - The company has a commitment to employee health and well-being, sponsoring a Month of Wellness with various activities[96]. - The company maintains dedicated Environmental Health and Safety departments at major worksites to ensure effective health and safety programs[98]. - The company emphasizes the importance of creating safe environments to prevent injuries and occupational diseases[97]. Cybersecurity and Operational Risks - IT systems are critical to the company's operations, and disruptions could materially impact business performance and reputation[134]. - The company faces significant software and hardware risks related to its iTero intraoral scanners, which could materially impact its business and financial results[136]. - A substantial portion of clear aligner production relies on digital scans from the iTero and third-party intraoral scanners, and any failures in interoperability could adversely affect operations and sales[138]. - The company is highly dependent on third-party suppliers for key components, and disruptions in supply could materially affect its financial condition and results of operations[139]. - Changes in key supplier relationships could lead to production interruptions and inefficiencies, potentially resulting in lost revenues[140]. - The company relies on distributors for marketing and sales, and any failure of these distributors to comply with laws could harm the company's reputation and financial results[141]. - Disruptions in freight carrier operations or increased shipping costs could negatively impact the company's supply chain and financial results[142]. - The company is dependent on attracting and retaining skilled personnel, and failure to do so could adversely affect its strategic priorities and financial condition[143]. - The Chief Information Security Officer (CISO) leads the company's information security strategy and has over 20 years of experience in the field[205]. - The company conducts annual cybersecurity enterprise risk assessments and presents the results to management and the Audit Committee[206]. - The Audit Committee oversees the company's cybersecurity risks and meets regularly with the CISO to discuss threats[207].

Financial Data and Key Metrics Changes - Q4 2024 total revenues were $995 million, a 4% increase year-over-year, with Clear Aligner revenues growing 1.6% and Systems and Services revenues increasing 14.9% [9][11][27] - For the full year 2024, total revenues reached $4 billion, reflecting a 3.5% year-over-year increase [11] - Q4 2024 non-GAAP operating margin was 23.2%, up 1.1% sequentially but down 0.6% year-over-year [40] Business Line Data and Key Metrics Changes - Clear Aligner volumes grew 6.1% year-over-year in Q4, with significant growth in EMEA, APAC, and LatAm regions [9][12] - Systems and Services revenues in Q4 were $200.9 million, up 14.9% year-over-year, driven by higher scanner volumes and non-systems revenue [33] - Q4 Clear Aligner average selling price (ASP) was $1,265, down $55 year-over-year due to product mix and higher discounts [30][36] Market Data and Key Metrics Changes - In the Americas, Clear Aligner volumes reflected strength in Latin America and improving trends in North America, while EMEA showed growth from core Europe and emerging markets [12][14] - APAC region growth was driven by China and Japan, with strong performance in emerging markets like India and Thailand [12][14] - The number of doctors submitting cases reached a record 85,700 worldwide in Q4, indicating increased engagement [13] Company Strategy and Development Direction - The company is focused on enhancing clinical outcomes and efficiency in orthodontics, with plans to commercialize the Invisalign Palatal Expander across EMEA in 2025 [17][18] - Continued investment in digital workflows and partnerships with dental support organizations (DSOs) to drive adoption of digital dentistry [22][23] - The launch of the iTero Lumina scanner with restorative capabilities is expected to enhance practice efficiency and patient outcomes [25][59] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the competitive landscape, citing innovations that position the company favorably against competitors [69] - The company anticipates mid-single-digit growth in Clear Aligner volumes for 2025, despite macroeconomic uncertainties [67][101] - Management highlighted the importance of new product launches and the potential for growth in the GP channel [90][100] Other Important Information - The company completed a $30 million equity investment in Smile Doctors, enhancing its presence in the DSO market [22][44] - A favorable outcome with UK tax authorities resulted in a $100 million VAT refund, impacting financials positively [31][32] - The company plans to raise Clear Aligner list prices by approximately 3% in March 2025, while removing certain processing fees [47][48] Q&A Session Summary Question: Can you provide more details on the guidance for Clear Aligners? - Management expects mid-single-digit volume growth for Clear Aligners in 2025, reflecting a stable exit from 2024 [67] Question: How do you view competitive dynamics in the market? - Management sees no significant changes in competitive dynamics, with confidence in their innovations and market position [69] Question: What are the expectations for the Lumina scanner launch? - The Lumina scanner is expected to enhance practice efficiency, with positive feedback from orthodontic users [76][78] Question: Can you elaborate on the growth from DSOs? - DSOs are seen as a force multiplier, helping to disseminate technology and efficiency across practices [106]

Revenue Performance - Q4'24 total revenues reached $995.2 million, up 4.0% year-over-year, while FY2024 total revenues were $4.0 billion, up 3.5% year-over-year[1][2][3] - Q4'24 Clear Aligner revenues were $794.3 million, reflecting a 1.6% increase year-over-year, with total Clear Aligner shipments of 628,730 units, up 6.1% year-over-year[4][7] - Q4'24 Systems and Services revenues were $200.9 million, up 14.9% year-over-year, contributing to a total of $768.9 million for FY2024, which is a 16.0% increase from FY2023[4][8] - Clear Aligner volumes for FY2024 totaled 2.5 million cases, representing a 3.5% increase year-over-year[5][8] - GAAP net revenues for fiscal 2024 reached $3,999,012, a 3.5% increase from $3,862,260 in 2023[38] - Clear Aligner net revenues were $3,230,122, up from $3,199,329, reflecting a 1.0% constant currency impact[38] Profitability Metrics - FY2024 operating margin was 15.2%, with a non-GAAP operating margin of 21.8%, while diluted net income per share was $5.62, down 5.3% from FY2023[3][8] - Q4'24 net income was $103.8 million, or $1.39 per diluted share, impacted by foreign exchange losses of approximately $0.14 per diluted share[4][6] - GAAP income from operations for Q4 2024 was $144,149, down from $171,545 in Q4 2023, resulting in an operating margin of 14.5%[41] - Non-GAAP net income for Q4 2024 was $181,644,000, slightly down from $183,469,000 in Q4 2023, representing a decrease of 1.0%[44] - GAAP diluted net income per share for Q4 2024 was $1.39, down from $1.64 in Q4 2023, a decline of 15.2%[44] - Non-GAAP diluted net income per share for Q4 2024 was $2.44, compared to $2.42 in Q4 2023, an increase of 0.8%[44] Cash and Investments - The company repurchased $352.9 million of common stock in 2024, concluding the year with no debt and approximately $1,044 million in cash and cash equivalents[3][10] - Cash and cash equivalents at the end of 2024 were $1,043,887 thousand, up from $937,438 thousand at the end of 2023[33] - The company reported a total stockholders' equity of $3,851,985 thousand as of December 31, 2024, an increase from $3,630,489 thousand in 2023[33] - The company initiated a plan to repurchase $275 million of common stock, with approximately $202.9 million spent by December 31, 2024[18] - As of January 31, 2025, $225 million remains available for stock repurchases under the program approved in January 2023[18] Future Outlook - For Q1'25, the company expects worldwide revenues to be in the range of $965 million to $985 million, down sequentially from Q4 due to unfavorable foreign exchange and lower capital equipment sales[20] - Clear Aligner volume is expected to increase slightly sequentially in Q1'25, while Clear Aligner average selling prices (ASPs) are anticipated to decrease sequentially[20] - The company projects a year-over-year revenue growth of low single digits for 2025, reflecting approximately 2 points of unfavorable foreign exchange[20] - Clear Aligner volume growth for 2025 is expected to be up approximately mid-single digits year-over-year, compared to a 3.5% increase in 2024[20] - The company plans to invest between $100 million and $150 million in capital expenditures for fiscal 2025, primarily for building construction and manufacturing capacity[20] Operational Metrics - The company achieved 271.6 thousand active Invisalign trained practitioners and over 19.5 million Invisalign patients, including over 5.6 million teens and kids[5][6] - The number of Invisalign trained doctors receiving cases in Q4 2024 was 85,685, a slight decrease from 83,700 in Q4 2023[35] - Clear Aligner revenue per case shipment in Q4 2024 was $1,265, down from $1,320 in Q4 2023[35] Cost and Expenses - Total operating expenses increased to $552,792 thousand in Q4 2024 from $497,979 thousand in Q4 2023, driven by higher selling, general and administrative expenses[32] - Total operating expenses for fiscal 2024 were $2,191,531, compared to $2,063,525 in 2023, indicating increased investment in operations[43] - Stock-based compensation for Q4 2024 was $38,848,000, consistent with $38,829,000 in Q4 2023[44] - The company initiated restructuring plans in Q4 2024, incurring restructuring charges of $36,991,000, compared to $13,989,000 in Q4 2023[44] - Legal settlement loss for the year ended December 31, 2024, was $30,968,000, compared to no losses in the previous year[44] Market Position and Strategy - Align Technology completed a $30.0 million equity investment in Smile Doctors, enhancing its market position in the orthodontic sector[9] - Align Technology plans to raise the list price of Clear Aligners by approximately 3% on average in the Americas and EMEA regions starting March 1, 2025[16] - The company is monitoring the U.S./Mexico tariff situation closely, with a potential 25% tariff on goods from Mexico still making it more economical to ship clear aligners from Mexico to the U.S.[17]

PART I FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited condensed consolidated financial statements for Q3 and nine months ended September 30, 2024, covering operations, balance sheets, cash flows, and detailed notes [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q3 2024 net revenues slightly increased to **$977.9 million**, while net income decreased to **$116.0 million**; nine-month revenues grew to **$3.00 billion** with a slight net income decrease Q3 & Nine Months 2024 Statement of Operations (in thousands, except per share data) | Metric | Q3 2024 | Q3 2023 | Nine Months 2024 | Nine Months 2023 | | :--- | :--- | :--- | :--- | :--- | | **Net Revenues** | $977,872 | $960,214 | $3,003,793 | $2,905,534 | | **Gross Profit** | $681,774 | $663,076 | $2,102,218 | $2,037,339 | | **Income from Operations** | $162,298 | $166,346 | $463,479 | $471,793 | | **Net Income** | $115,963 | $121,427 | $317,555 | $321,039 | | **Diluted EPS** | $1.55 | $1.58 | $4.23 | $4.18 | [Condensed Consolidated Statements of Comprehensive Income](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income) Q3 2024 comprehensive income increased to **$126.8 million** due to foreign currency adjustments, while the nine-month comprehensive income remained nearly flat at **$332.3 million** Q3 & Nine Months 2024 Comprehensive Income (in thousands) | Metric | Q3 2024 | Q3 2023 | Nine Months 2024 | Nine Months 2023 | | :--- | :--- | :--- | :--- | :--- | | **Net Income** | $115,963 | $121,427 | $317,555 | $321,039 | | **Other Comprehensive Income (Loss)** | $10,872 | $(9,296) | $14,745 | $12,331 | | **Comprehensive Income** | $126,835 | $112,131 | $332,300 | $333,370 | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to **$6.37 billion** as of September 30, 2024, driven by higher cash, while total liabilities remained stable and stockholders' equity grew to **$3.94 billion** Balance Sheet Highlights (in thousands) | Metric | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $1,041,935 | $937,438 | | **Total current assets** | $2,597,387 | $2,446,618 | | **Total assets** | $6,365,974 | $6,083,877 | | **Total current liabilities** | $2,063,613 | $2,066,611 | | **Total liabilities** | $2,421,620 | $2,453,388 | | **Total stockholders' equity** | $3,944,354 | $3,630,489 | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased to **$3.94 billion** by September 30, 2024, primarily due to **$317.6 million** in net income, partially offset by **$150.6 million** in stock repurchases - For the nine months ended September 30, 2024, the company repurchased and retired 634,000 shares of common stock for a total cost of **$150.6 million**[14](index=14&type=chunk) - Stock-based compensation expense for the nine months ended September 30, 2024, was **$134.9 million**[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operations decreased to **$452.2 million** for the nine months ended September 30, 2024, with **$201.0 million** used in investing and **$152.7 million** in financing activities Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | **Net cash provided by operating activities** | $452,153 | $738,878 | | **Net cash used in investing activities** | $(200,996) | $(182,619) | | **Net cash used in financing activities** | $(152,703) | $(248,059) | | **Net increase in cash** | $104,462 | $296,995 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, the **$85.8 million** Cubicure acquisition, a **$31.1 million** antitrust legal accrual, a **$100 million** VAT refund, and a post-quarter restructuring plan costing **$25-$30 million** - On January 2, 2024, the company completed the acquisition of Cubicure GmbH for a total purchase consideration of **$85.8 million**, resulting in **$47.6 million** of goodwill allocated to the Clear Aligner segment[53](index=53&type=chunk)[54](index=54&type=chunk)[56](index=56&type=chunk) - During the nine months ended September 30, 2024, the company accrued a loss of **$31.1 million** for legal settlements, primarily related to Section 1 antitrust claims[74](index=74&type=chunk) - In October 2024, the company reached a settlement with UK's HMRC regarding a VAT dispute, resulting in a full refund of approximately **$100 million** in previously paid assessments[78](index=78&type=chunk) - Subsequent to the quarter end, on October 23, 2024, the company announced a restructuring plan to reduce headcount by approximately 700 employees, with estimated costs of **$25.0 million** to **$30.0 million**[108](index=108&type=chunk) - On October 25, 2024, the company announced a plan to repurchase **$275.0 million** of its common stock through open market repurchases[109](index=109&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q3 2024 financial results, noting a **1.8%** revenue increase to **$977.9 million** driven by Systems and Services growth, macroeconomic challenges, and a slight operating margin decrease, while maintaining strong liquidity [Executive Overview of Results](index=26&type=section&id=Executive%20Overview%20of%20Results) The company's strategic priorities include international expansion and GP treatment, with Q3 2024 revenues reaching **$977.9 million**, up **1.8%** YoY, despite ongoing macroeconomic challenges - The company's growth strategy focuses on four pillars: international expansion, general practitioner (GP) treatment, patient demand, and orthodontic utilization[112](index=112&type=chunk) - Management believes sales have been and will continue to be impacted by macroeconomic conditions, including inflation and market uncertainties from military conflicts, which dampen consumer sentiment and demand[113](index=113&type=chunk) Q3 2024 Key Metrics | Metric | Value | Change (YoY) | | :--- | :--- | :--- | | Revenues | $977.9M | +1.8% | | Clear Aligner Revenues | $786.8M | -1.0% | | Systems & Services Revenues | $191.0M | +15.6% | | Clear Aligner Case Volume | - | +2.5% | | Operating Margin | 16.6% | - | [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Q3 2024 net revenues increased by **$17.7 million** YoY, driven by a **15.6%** rise in Systems and Services revenue, offsetting a **1.0%** decline in Clear Aligner revenue, while gross margins varied by segment and operating expenses rose Net Revenues by Segment (in millions) | Segment | Q3 2024 | Q3 2023 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | **Clear Aligner** | $786.8 | $794.9 | $(8.1) | (1.0)% | | Americas | $349.2 | $366.6 | $(17.4) | (4.7)% | | International | $361.5 | $355.3 | $6.2 | 1.8% | | **Systems and Services** | $191.0 | $165.3 | $25.8 | 15.6% | | **Total Net Revenues** | $977.9 | $960.2 | $17.7 | 1.8% | Gross Margin by Segment | Segment | Q3 2024 | Q3 2023 | | :--- | :--- | :--- | | **Clear Aligner** | 70.3% | 70.7% | | **Systems and Services** | 67.5% | 61.0% | | **Total Gross Margin** | 69.7% | 69.1% | - Selling, general and administrative (SG&A) expenses increased in Q3 2024 compared to Q3 2023, primarily due to higher employee costs, including salary, benefits, stock-based compensation, and bonus[150](index=150&type=chunk) - For the nine months ended September 30, 2024, the company recorded a legal settlement loss of **$31.2 million**[156](index=156&type=chunk)[157](index=157&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2024, the company held **$1.04 billion** in cash, with **$452.2 million** from operations, and plans over **$100 million** in capital expenditures, ongoing share repurchases, and a **$25-$30 million** restructuring cost - The company's cash and cash equivalents totaled **$1.04 billion** as of September 30, 2024[169](index=169&type=chunk) - Capital expenditures for 2024 are expected to be above **$100.0 million**, primarily for building construction and manufacturing capacity expansion[171](index=171&type=chunk) - As of September 30, 2024, **$500.0 million** remained available for repurchases under the January 2023 stock repurchase program[172](index=172&type=chunk) - A restructuring plan announced in October 2024 is expected to incur charges between **$25.0 million** and **$30.0 million**[176](index=176&type=chunk) [Critical Accounting Estimates](index=36&type=section&id=Critical%20Accounting%20Estimates) Revenue recognition, particularly determining standalone selling price (SSP) for multi-option treatment plans, is a critical accounting estimate requiring significant judgment that can materially impact revenue timing - Revenue recognition is a critical accounting estimate, specifically the determination of standalone selling price (SSP) to allocate revenue to distinct performance obligations[184](index=184&type=chunk) - Estimating SSP for clear aligner treatment plans requires significant judgment and evaluation of inputs, including historical usage data by region, country, and channel[185](index=185&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces significant market risks from foreign currency fluctuations, inflation impacting costs and revenues, and interest rate changes, with a **10%** currency shift potentially having a material impact - The company has significant international operations and is exposed to fluctuations in foreign currencies; a **10%** aggregate change in foreign currency exchange rates could be material[191](index=191&type=chunk)[193](index=193&type=chunk) - The company uses foreign currency forward contracts, primarily for the Euro, British Pound, Chinese Yuan, Polish Zloty, and Canadian Dollar, to minimize short-term impacts of currency fluctuations[192](index=192&type=chunk) - Rising inflation has impacted and is expected to continue to impact revenues and costs globally; the company may not be able to fully offset higher costs through price increases[194](index=194&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2024, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of September 30, 2024[195](index=195&type=chunk) - No material changes were made to the company's internal control over financial reporting during the quarter ended September 30, 2024[196](index=196&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in multiple legal matters, including a settled shareholder derivative suit, an antitrust class action settlement for **$27.5 million**, and ongoing patent infringement litigation against Straumann, accruing **$31.1 million** in legal losses - A 2019 shareholder derivative lawsuit reached a settlement agreement, which received preliminary court approval on August 2, 2024[69](index=69&type=chunk)[199](index=199&type=chunk) - In June 2024, the company reached a settlement in principle in an antitrust lawsuit, which includes a **$27.5 million** cash payment and coupons for class members; a renewed motion for preliminary approval was filed in October 2024[73](index=73&type=chunk) - In April 2024, Align filed a lawsuit against ClearCorrect/Straumann for false advertising and patent infringement; Straumann has filed counterclaims for antitrust violations and other claims[75](index=75&type=chunk) - For the nine months ended September 30, 2024, the company accrued a loss of **$31.1 million** for legal settlements, primarily related to the antitrust claims[74](index=74&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from macroeconomic pressures, geopolitical events, intense competition, product dependence, supply chain disruptions, cybersecurity threats, and legal, regulatory, and ESG compliance failures [Macroeconomic and External Risks](index=40&type=section&id=Macroeconomic%20and%20External%20Risks) The company's performance is vulnerable to macroeconomic conditions like inflation, currency fluctuations, and recessions, alongside geopolitical events that can disrupt operations and supply chains - Macroeconomic conditions like inflation and potential recessions can adversely affect consumer confidence and discretionary spending on the company's products[202](index=202&type=chunk) - Significant international operations expose the company to material foreign currency fluctuations[204](index=204&type=chunk) - Geopolitical events, including the conflict in the Middle East, could disrupt iTero operations, which are headquartered in Israel[209](index=209&type=chunk) [Business and Industry Risks](index=41&type=section&id=Business%20and%20Industry%20Risks) Business risks include reliance on core products, intense competition from various clear aligner providers, challenges in new product adoption, and operational vulnerabilities from supply chain dependence and IT system disruptions - Net revenues are largely dependent on sales of Invisalign treatment plans and iTero intraoral scanners[216](index=216&type=chunk) - Competition is increasing rapidly from traditional wires and brackets, other clear aligner manufacturers, direct-to-consumer companies, and doctors using in-office 3D printing[221](index=221&type=chunk) - The company is highly dependent on third-party suppliers, some of whom are sole-source suppliers for key machines and materials, creating supply chain vulnerability[245](index=245&type=chunk) - The business relies on complex IT systems, and issues with software integration, updates, or cybersecurity could disrupt operations and harm the company's reputation[239](index=239&type=chunk)[240](index=240&type=chunk) [Legal, Regulatory and Compliance Risks](index=47&type=section&id=Legal%2C%20Regulatory%20and%20Compliance%20Risks) The company faces significant legal, regulatory, and compliance risks from extensive global regulations, potential cybersecurity breaches, product liability claims, increasing ESG scrutiny, and emerging AI-related legal challenges - The company is subject to extensive and frequently changing regulations for medical devices, data privacy, marketing, and anti-corruption, with non-compliance potentially leading to significant penalties[265](index=265&type=chunk)[270](index=270&type=chunk) - Cybersecurity incidents, data breaches, and failure to comply with privacy laws could lead to litigation, regulatory action, and reputational harm[273](index=273&type=chunk)[274](index=274&type=chunk) - Increasing focus on Environmental, Social, and Governance (ESG) laws and stakeholder expectations may materially increase costs and expose the company to liability and reputational risk[281](index=281&type=chunk)[288](index=288&type=chunk) - The incorporation of Artificial Intelligence (AI) into products and operations presents new legal, regulatory, and reputational risks[289](index=289&type=chunk)[290](index=290&type=chunk) [Intellectual Property Risks](index=51&type=section&id=Intellectual%20Property%20Risks) The company's success depends on its ability to obtain and enforce intellectual property rights, facing risks of patent invalidation and costly, unpredictable IP litigation - The company's success depends on its ability to obtain, maintain, and enforce its portfolio of patents and other intellectual property rights[291](index=291&type=chunk)[292](index=292&type=chunk) - The company is and will likely continue to be involved in extensive and costly litigation over IP rights, the outcomes of which are unpredictable and could adversely affect the business[300](index=300&type=chunk) [Financial, Tax and Accounting Risks](index=52&type=section&id=Financial%2C%20Tax%20and%20Accounting%20Risks) The company faces financial risks from potential asset impairment, changes in accounting rules, volatile effective tax rates due to evolving laws, and historical stock price volatility - Goodwill, intangible, or other long-lived assets could become impaired, which would require the company to record a material charge to earnings[301](index=301&type=chunk) - The company's effective tax rate may vary significantly due to changes in tax laws, regulations, and the jurisdictional mix of income[307](index=307&type=chunk)[310](index=310&type=chunk) - The market price of the company's common stock has been historically volatile and is subject to fluctuations from numerous factors beyond its control[313](index=313&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=54&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No stock repurchases occurred during Q3 2024, with **$500.0 million** remaining available under the January 2023 repurchase program - There were no stock repurchases during the three months ended September 30, 2024[318](index=318&type=chunk) - As of September 30, 2024, **$500.0 million** remained available for repurchases under the January 2023 Repurchase Program[318](index=318&type=chunk) [Defaults Upon Senior Securities](index=54&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company's current financial reporting - Not applicable[319](index=319&type=chunk) [Mine Safety Disclosures](index=54&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations - Not applicable[319](index=319&type=chunk) [Other Information](index=54&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated Rule 10b5-1 trading arrangements during Q3 2024 - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the fiscal quarter ended September 30, 2024[319](index=319&type=chunk) [Exhibits](index=55&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents, CEO and CFO certifications, and Inline XBRL documents - The report includes a list of filed exhibits, such as CEO and CFO certifications (Exhibits 31.1, 31.2, 32.1) and Inline XBRL data files[321](index=321&type=chunk)

Align Technology, Inc. (NASDAQ:ALGN) Q3 2024 Earnings Conference Call October 23, 2024 4:30 PM ET Company Participants Shirley Stacy - VP, Corporate Communications & IR Joe Hogan - President & Chief Executive Officer John Morici - Chief Financial Officer Conference Call Participants Brandon Vazquez - William Blair Jon Block - Stifel Elizabeth Anderson - Evercore ISI Jason Bednar - Piper Sandler David Saxon - Needham & Company Jeff Johnson - Baird Kevin Caliendo - UBS Michael Cherny - Leerink Partners Erin W ...