O IQ In | 米 invisalign | Tero ©2024 Align Technology Inc. All rights reserved. 1 exocad Q3 2024 Financial Results Align Technology, Inc. October 23, 2024 Q3 2024 Conference Call Details Conference call Speakers: Joe Hogan, President and CEO John Morici, CFO Shirley Stacy, VP, Finance, Investor Relations and Corporate Communications Webcast Archive: Audio webcast archive will be available at http://investor.aligntech.com for one month Contacts Website: http://investor.aligntech.com Email: investorinfo@alignt ...

Revenue Performance - Q3'24 total revenues were $977.9 million, an increase of 1.8% year-over-year, but a decrease of 4.9% sequentially[1] - Q3'24 Clear Aligner revenues were $786.8 million, down 5.4% sequentially and down 1.0% year-over-year[1] - Q3'24 Imaging Systems and CAD/CAM Services revenues were $191.0 million, an increase of 15.6% year-over-year[1] - Net revenues for Q3 2024 reached $977.872 million, a 1.7% increase from $960.214 million in Q3 2023[25] - GAAP net revenues for Q3 2024 were $977,872, a year-over-year increase of 1.8% from $960,214 in Q3 2023[34] - Clear Aligner net revenues for Q3 2024 were $786,844, down from $794,939 in Q3 2023, reflecting a year-over-year decrease of 1.4%[35] - Imaging Systems and CAD/CAM Services net revenues for Q3 2024 were $191,028, up 15.6% from $165,275 in Q3 2023[35] - Constant currency net revenues for Q3 2024 were $977,747, reflecting no impact from foreign exchange[34] Profitability Metrics - Q3'24 operating income was $162.3 million, resulting in an operating margin of 16.6%, down 0.7 points year-over-year[2] - Q3'24 net income was $116.0 million, or $1.55 per diluted share, with non-GAAP net income of $175.6 million, or $2.35 per diluted share[2] - Gross profit for Q3 2024 was $681.774 million, compared to $663.076 million in Q3 2023, reflecting a gross margin improvement[25] - GAAP gross profit for Q3 2024 was $681,774, compared to $663,076 in Q3 2023, resulting in a gross margin of 69.7%[39] - Non-GAAP gross profit for Q3 2024 was $688,546,000, compared to $667,875,000 in Q3 2023, reflecting a year-over-year increase of 3.1%[43] - GAAP net income for Q3 2024 was $115,963,000, down from $121,427,000 in Q3 2023, a decrease of 4.0%[45] - Non-GAAP net income for Q3 2024 was $175,622,000, up from $164,321,000 in Q3 2023, indicating a growth of 6.5%[45] - GAAP operating margin for Q3 2024 was 16.6%, slightly down from 17.3% in Q3 2023[43] - Non-GAAP operating margin for Q3 2024 was 22.1%, compared to 21.8% in Q3 2023, showing an improvement of 1.4%[45] Operating Expenses and Cash Flow - Operating expenses increased to $519.476 million in Q3 2024 from $496.730 million in Q3 2023, with R&D expenses slightly decreasing to $85.272 million[25] - The company reported a total operating expense of $519,476,000 for Q3 2024, an increase from $496,730,000 in Q3 2023, reflecting a rise of 4.0%[43] - Net cash provided by operating activities for Q3 2024 was $452.153 million, a decrease from $738.878 million in Q3 2023[29] - As of September 30, 2024, cash and cash equivalents were $1.0 billion, up from $761.4 million as of June 30, 2024[1] - Cash and cash equivalents increased to $1.042 billion as of September 30, 2024, up from $937.438 million at the end of 2023[27] Future Outlook - The company plans to repurchase up to $275.0 million of its common stock beginning in Q4'24[1] - For Q4'24, the company expects worldwide revenues to be in the range of $995 million to $1,015 million[11] - Q4'24 GAAP operating margin is expected to be slightly lower than 14.0% due to restructuring charges impacting operating margin by approximately 3 points[11] - The company anticipates incurring restructuring charges of approximately $30 million in Q4'24[6] - Align Technology anticipates continued growth in Clear Aligner volume and ASP, with expectations for Q4 2024 revenues to remain strong[21] - The company expects continued growth in the number of trained doctors and utilization rates in the upcoming quarters[31] Balance Sheet Highlights - Total assets grew to $6.366 billion as of September 30, 2024, compared to $6.084 billion at the end of 2023[27] - Total stockholders' equity increased to $3.944 billion from $3.630 billion at the end of 2023[27] - The company reported a decrease in deferred revenues to $1.380 billion from $1.428 billion at the end of 2023[27] Utilization and Training - The number of Invisalign trained doctors increased to 85,195 in Q3 2023, up from 83,440 in Q2 2023[31] - Total utilization rates for North America in Q3 2024 were 9.6%, with North American orthodontists at 28.8% and GP dentists at 4.9%[31] - Stock-based compensation included in gross profit for Q3 2024 was $1,974, compared to $1,901 in Q2 2023[32] - Stock-based compensation for Q3 2024 was $49,039,000, compared to $39,602,000 in Q3 2023, an increase of 23.0%[45]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________ FORM 10-Q ____________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 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 ...

Financial Data and Key Metrics Changes - Total Q2 2024 revenues were $1,028.5 million, up 3.1% sequentially and 2.6% year-over-year, driven by growth in Clear Aligner volumes and Imaging Systems and CAD/CAM Services revenues [7][23] - Q2 2024 non-GAAP operating margin was 22.3%, up 2.5 points sequentially and 1.0 point year-over-year [9][32] - Q2 2024 net income per diluted share was $1.28, down sequentially $0.11 and down $0.18 year-over-year, while non-GAAP net income per diluted share was $2.41, up $0.27 sequentially and $0.19 year-over-year [34] Business Line Data and Key Metrics Changes - Clear Aligner revenues for Q2 2024 were $831.7 million, up 1.8% sequentially but flat year-over-year, impacted by lower ASPs and higher discounts [23][24] - Imaging Systems and CAD/CAM Services revenues increased 9.2% sequentially and 16.1% year-over-year, reflecting strong adoption of the iTero Lumina scanner [10][19] - Non-Case revenues, including Vivera retainers, were up 3.5% sequentially and 5.1% year-over-year, driven by growth in retainers and the Doctor Subscription Program [12] Market Data and Key Metrics Changes - Clear Aligner volumes increased 6.2% sequentially and 3.2% year-over-year, with strong growth from adult patients and teen case starts, particularly in Asia Pacific, EEMA, and Latin America [8][11] - The number of doctors submitting teen or younger patient case starts was up 8% year-over-year, indicating strong adoption in the teen segment [11] - The adoption of the my Invisalign consumer patient app increased, with over 4 million downloads and 384,000 monthly active users, reflecting a growing digital engagement [18] Company Strategy and Development Direction - The company continues to invest in consumer marketing and demand creation initiatives to raise awareness of Invisalign, with over 17 billion impressions globally [15][16] - The introduction of the iTero Design Suite aims to enhance practice efficiencies and patient experiences through 3D printing capabilities [21] - The company is focused on expanding its digital platform and enhancing the adoption of digital workflows in the dental industry, particularly through partnerships with Dental Service Organizations (DSOs) [14][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stability of end markets despite unfavorable foreign exchange impacts, emphasizing the commitment to support doctor customers in digital innovation [38] - The company anticipates Q3 2024 revenues to be in the range of $980 million to $1 billion, with expectations of lower Clear Aligner volumes and ASPs due to seasonality [36][37] - For fiscal 2024, total revenue growth is expected to be 4% to 6% year-over-year, with a focus on maintaining operational efficiency and profitability [37] Other Important Information - The company repurchased approximately 0.6 million shares at an average price of $250.73, with $500 million remaining for future repurchases [35] - Cash flow from operations for Q2 was $159.8 million, with capital expenditures of $53.5 million primarily for manufacturing capacity expansion [36] Q&A Session Summary Question: Insights on guidance change and ASP dynamics - Management noted that unfavorable foreign exchange impacts and a shift in product mix to lower ASP products contributed to the guidance change, with a focus on what doctors want to buy [42][43] Question: Impact of iTero restorative scan revenue on guidance - The expected revenue from the iTero restorative launch was factored into the original guidance, and its delay contributed to the overall guidance reduction [45][46] Question: ASP decline details - The decline in ASP was attributed to a mix of lower-priced products being sold and increased utilization of the Doctor Subscription Program, which has a lower ASP but better gross margins [50][51] Question: Doctor shipping numbers and competitive landscape - Management indicated that the increase in doctor shipments reflects a growing utilization and efforts to train more doctors, despite some competitive losses [58][59] Question: Direct Fab timelines and manufacturing updates - The timeline for Direct Fab is projected to be 2 to 3 years, with significant groundwork needed before achieving full operational efficiency [62] Question: Confidence in returning to normal seasonality - Management expressed optimism about returning to more normal seasonality based on observed trends in Q2 and expectations for the upcoming quarters [66]

align | * invisalign | iTero ©2024 Align Technology Inc. All rights reserved. 1 exocad Q2 2024 Financial Results Align Technology, Inc. July 24, 2024 Q2 2024 Conference Call Details | --- | |-------| | | | | | | | | | | | | | | | | | | | | | | | | | | Shirley Stacy, sstacy@aligntech.com Madelyn Valente, mvalente@aligntech.com ©2024 Align Technology Inc. All rights reserved. 2 Safe Harbor and Forward-Looking Statements This presentation, including the tables below, contains forward-looking statements, includ ...

Financial Performance - Q2'24 total revenues reached $1,028.5 million, reflecting a 3.1% sequential increase and a 2.6% year-over-year increase[2]. - Q2'24 diluted net income per share was $1.28, with a non-GAAP diluted EPS of $2.41, reflecting a 12.1% increase from the previous quarter[2][5]. - Align Technology reported net revenues of $1,028,490,000 for Q2 2024, a 2.5% increase from $1,002,173,000 in Q2 2023[27]. - Net income for Q2 2024 was $96,564,000, down from $111,814,000 in Q2 2023, representing a decrease of 13.6%[27]. - Basic and diluted net income per share for Q2 2024 was $1.28, compared to $1.46 in Q2 2023, indicating a decline of 12.3%[27]. - GAAP net revenues for Q2 2024 reached $1,028,490, reflecting a sequential increase of 3.1% from Q1 2024's $997,431[32]. - The company reported a year-over-year increase in GAAP net revenues from $1,002,173 in Q2 2023 to $1,028,490 in Q2 2024, representing a growth of 2.6%[32]. - GAAP net income for Q2 2024 was $96.6 million, down from $111.8 million in Q2 2023, a decrease of 13.6%[39]. Revenue Breakdown - Q2'24 Clear Aligner revenues were $831.7 million, up 1.8% sequentially but down 0.1% year-over-year, with a volume of 642.7 thousand cases, representing a 6.2% sequential increase and a 3.2% year-over-year increase[2][5]. - Q2'24 Imaging Systems and CAD/CAM Services revenues totaled $196.8 million, marking a 9.2% sequential increase and a 16.1% year-over-year increase[2][5]. - Clear Aligner net revenues for Q2 2024 were $831,738, up from $817,251 in Q1 2024, indicating a sequential growth of 2.0%[32]. - Clear Aligner revenue per case shipment decreased to $1,295 in Q2 2024 from $1,350 in Q1 2024[30]. Operating Income and Margins - The company reported a Q2'24 operating income of $147.0 million, resulting in a GAAP operating margin of 14.3%, which was impacted by foreign exchange fluctuations[4]. - GAAP income from operations for Q2 2024 was $147,046, with an operating margin of 14.3%, down from 15.5% in Q1 2024[35]. - GAAP operating margin for Q2 2024 was 14.3%, down from 17.2% in Q2 2023[37]. - Non-GAAP operating margin for Q2 2024 was 22.3%, up from 21.3% in Q2 2023[37]. - The company expects Q3 2024 GAAP operating margin to be slightly below 16.5% and non-GAAP operating margin to be approximately 21.8%[40]. - For fiscal 2024, the company anticipates GAAP operating margin to be slightly below 16.0% and non-GAAP operating margin to be above 21.4%[41]. Cash and Assets - As of June 30, 2024, Align Technology had over $782.1 million in cash and equivalents, down from $902.5 million as of March 31, 2024[7]. - Total assets as of June 30, 2024, were $6,158,324,000, an increase from $6,083,877,000 at the end of 2023[28]. - Total stockholders' equity increased to $3,757,908,000 as of June 30, 2024, compared to $3,630,489,000 at the end of 2023[28]. - Cash and cash equivalents decreased to $761,429,000 from $937,438,000 at the end of 2023, reflecting a decline of 18.8%[28]. Future Guidance - The company expects Q3'24 worldwide revenues to be in the range of $980 million to $1,000 million, with anticipated declines in Clear Aligner volume and ASPs due to seasonality and foreign exchange[13]. - Fiscal 2024 total revenue growth is projected to be between 4% to 6% year-over-year, influenced by lower Clear Aligner ASPs and the delayed launch of the iTero™ Lumina with restorative capabilities[13]. - The company provided guidance for Q3 2024, expecting worldwide revenues and Clear Aligner volumes to grow, although specific figures were not disclosed[22]. Research and Development - The company awarded twelve research grants totaling $300,000 to universities worldwide under its Annual Research Award Program[10]. - Align Technology continues to focus on expanding its market opportunities, particularly in the digital orthodontics sector, with a consumer market opportunity of 600 million worldwide[19]. Stock-Based Compensation - Stock-based compensation included in gross profit for Q2 2024 was $2,582, compared to $2,064 in Q1 2024[31]. - Stock-based compensation for Q2 2024 was $47.0 million, compared to $37.9 million in Q2 2023, indicating an increase of 24.5%[39].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________ FORM 10-Q ____________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 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 ...

Financial Data and Key Metrics Changes - Total worldwide revenues for Q1 2024 were $997.4 million, up 5.8% year-over-year and up 4.3% sequentially [24][8] - Clear Aligner revenues were $817.3 million, reflecting a 3.5% year-over-year increase and a 4.5% sequential increase [24][25] - Systems and Services revenue was $180.2 million, up 17.5% year-over-year and up 3.1% sequentially [29][24] - Overall gross margin was 70%, flat sequentially and year-over-year [31][32] - Q1 net income per diluted share was $1.39, down sequentially but up $0.26 year-over-year [36] Business Line Data and Key Metrics Changes - Clear Aligner segment saw a 5.8% increase in total Invisalign case starts from teens and younger patients year-over-year [8][13] - Systems and Services revenue growth was driven by iTero Lumina wand upgrades and higher scanner volumes [9][29] - Non-case revenues for Clear Aligners increased by 7.5% year-over-year, primarily due to growth from Vivera retainers and Invisalign DSP retainer revenues [12] Market Data and Key Metrics Changes - Strong Clear Aligner volumes were primarily driven by the Asia Pacific region [8] - In the Americas region, Clear Aligner volume was consistent with the prior year [11] - Teen market saw nearly 200,000 teens starting treatment with Invisalign Clear Aligners in Q1, up 5.8% year-over-year [13] Company Strategy and Development Direction - The company completed the acquisition of Cubicure to enhance its 3D printing capabilities [9] - The launch of the iTero Lumina intraoral scanner is expected to set a new standard of care for dental practices [42] - The Invisalign Palatal Expander system is anticipated to expand the clinical applicability of the Invisalign system [43] Management's Comments on Operating Environment and Future Outlook - Management described the current business environment as stable across global markets [47][48] - The company expects Q2 2024 revenues to be in the range of $1.030 billion to $1.050 billion [39] - Fiscal 2024 total revenue is expected to increase by 6% to 8% compared to 2023, reflecting strong execution of growth strategies [40] Other Important Information - The company reported a cash balance of $902.5 million as of March 31, 2024, down sequentially [36] - Capital expenditures for Q1 were $9.4 million, primarily for increasing aligner manufacturing capacity [38] - The company plans to repurchase up to $150 million of its common stock in Q2 2024 [37] Q&A Session Summary Question: How is the overall demand environment, particularly in the U.S.? - Management described the business as stable globally, with no significant changes attributed to competitors like SmileDirectClub [46][50] Question: What is the commercialization outlook for the teen market with the new Palatal Expander? - The company believes the Palatal Expander will enhance acceptance of Phase 1 treatments among orthodontists, potentially increasing market penetration [53][55] Question: Can you elaborate on month-to-month trends in Q1? - Management noted stability throughout the quarter, with no significant month-to-month fluctuations impacting overall performance [57][58] Question: What is the expected growth for the scanner and CAD/CAM services? - The company anticipates continued double-digit growth in scanner and CAD/CAM services, driven by new product launches [62][64] Question: What percentage of cases are financed through third-party companies? - Approximately one-third of cases utilize some form of external financing, with stable lending standards reported [66][68]

Financial Performance - Total worldwide revenues for Q1 2024 were $997.4 million, up 5.8% year-over-year [27, 30] - Clear Aligner revenues were $817.3 million, a 3.5% increase year-over-year [30] - Systems and Services revenues reached $180.2 million, showing a 17.5% year-over-year growth [27, 30] - GAAP operating profit margin was 15.5%, representing a $154.1 million profit [30] - Q1 2024 net income per diluted share was $1.39 [84] Clear Aligner Segment - Clear Aligner case volume increased by 2.1% quarter-over-quarter [71] - Invisalign ASPs for comprehensive treatment increased both quarter-over-quarter and year-over-year, while non-comprehensive treatment ASPs decreased in both comparisons [73] - Clear aligner shipments include over 23,000 Invisalign DSP touch-up cases, an increase of approximately 49% year-over-year [42] Systems and Services Segment - Systems and Services revenues increased by 17.5% year-over-year [30] - exocad reached more than 60,000 licenses sold [67] Consumer and Marketing - Consumer marketing campaigns in the Americas delivered more than 6.1 billion impressions and 18.1 million unique website visitors [55]

[Company Information & Contact](index=1&type=section&id=Company%20Information%20%26%20Contact) This section provides essential contact details for Align Technology's media relations team [Contact Information](index=1&type=section&id=Contact%20Information) Align Technology's media contacts are Madelyn Valente and Sarah Johnson, handling communications for Align Technology and Zeno Group respectively - Align Technology's media contacts are Madelyn Valente (mvalente@aligntech.com) and Sarah Johnson (sarah.johnson@zenogroup.com) [1](index=1&type=chunk) [First Quarter 2024 Financial Results Overview](index=1&type=section&id=First%20Quarter%202024%20Financial%20Results%20Overview) This section details Align Technology's key financial performance metrics, CEO commentary, and liquidity position for Q1 2024 [Key Financial Highlights](index=1&type=section&id=Key%20Financial%20Highlights) Align Technology achieved year-over-year revenue and earnings growth in Q1 2024, with total revenue up 5.8% and non-GAAP diluted EPS at $2.14 Key Financial Data Q1 2024 (Year-over-Year) | Metric | Q1'24 Amount (Million USD) | Year-over-Year Growth | | :--- | :--- | :--- | | Total Revenue | $997.4 | 5.8% | | Clear Aligner Revenue | $817.3 | 3.5% | | Clear Aligner Shipments | 605.1 Thousand Cases | 2.4% | | Teen Clear Aligner Shipments | 199.2 Thousand Cases | 5.8% | | Imaging Systems and CAD/CAM Services Revenue | $180.2 | 17.5% | | Operating Income | $154.1 | - | | Operating Margin | 15.5% | - | | Non-GAAP Operating Margin | 19.8% | - | | Diluted Net Earnings Per Share | $1.39 | - | | Non-GAAP Diluted Net Earnings Per Share | $2.14 | - | - Foreign exchange had a favorable sequential impact of approximately **$10 million** on Q1'24 revenue, but an unfavorable year-over-year impact of approximately **$4.8 million** [2](index=2&type=chunk) - Foreign exchange had a favorable sequential impact of approximately **0.1 percentage points** on Q1'24 GAAP operating margin, but an unfavorable year-over-year impact of approximately **0.7 percentage points** [2](index=2&type=chunk) [CEO Commentary](index=2&type=section&id=CEO%20Commentary) CEO Joe Hogan expressed satisfaction with Q1'24 results, highlighting strong revenue growth across all regions and successful product launches - Q1'24 total revenue increased **5.8% year-over-year**, with Clear Aligner business growing **3.5%** and Systems and Services business growing **17.5%** [4](index=4&type=chunk) - Revenue growth was primarily driven by strong Clear Aligner volume in the Asia Pacific region and a **5.8% year-over-year increase** in Invisalign® case starts for teen and younger patients [4](index=4&type=chunk) - The company completed the acquisition of Cubicure GmbH, launched the iTero Lumina™ intraoral scanner, and introduced the Invisalign® Palatal Expander System in the US, Canada, Australia, and New Zealand [4](index=4&type=chunk) [Financial Summary Table](index=2&type=section&id=Financial%20Summary%20Table) Align Technology reported Q1 2024 total revenue of $997.4 million, with GAAP net income of $105.0 million and non-GAAP net income of $161.4 million Key Financial Metrics Q1 2024 | Metric | Q1'24 | Q4'23 | Q1'23 | Sequential Change | Year-over-Year Change | | :--- | :--- | :--- | :--- | :--- | :--- | | Clear Aligner Shipments | 605,060 Thousand Cases | 592,635 Thousand Cases | 590,940 Thousand Cases | +2.1% | +2.4% | | GAAP Net Revenue | $997.4M | $956.7M | $943.1M | +4.3% | +5.8% | | Clear Aligner Revenue | $817.3M | $781.9M | $789.8M | +4.5% | +3.5% | | Imaging Systems and CAD/CAM Services Revenue | $180.2M | $174.8M | $153.3M | +3.1% | +17.5% | | GAAP Net Income | $105.0M | $124.0M | $87.8M | (15.3)% | +19.6% | | GAAP Diluted EPS | $1.39 | $1.64 | $1.14 | ($0.24) | +$0.26 | | Non-GAAP Net Income | $161.4M | $183.5M | $140.6M | (12.0)% | +14.8% | | Non-GAAP Diluted EPS | $2.14 | $2.42 | $1.82 | ($0.28) | +$0.32 | [Cash and Liquidity](index=2&type=section&id=Cash%20and%20Liquidity) As of March 31, 2024, the company held over $902.5 million in cash and marketable securities, with a $300 million revolving credit facility - As of March 31, 2024, total cash, cash equivalents, and marketable securities were **$902.5 million**, down from **$980.8 million** as of December 31, 2023 [6](index=6&type=chunk) - The company has a **$300 million** revolving credit facility [6](index=6&type=chunk) [Q1 2024 Business and Strategic Highlights](index=3&type=section&id=Q1%202024%20Business%20and%20Strategic%20Highlights) This section outlines Align Technology's recent product launches, regulatory approvals, legal milestones, and strategic acquisitions in Q1 2024 [Product Launches & Regulatory Approvals](index=3&type=section&id=Product%20Launches%20%26%20Regulatory%20Approvals) Align Technology launched a new Invisalign advertising campaign, received regulatory approvals for its Palatal Expander System, and introduced the iTero Lumina™ intraoral scanner - On April 8, 2024, Align announced a new Invisalign brand advertising campaign, "Better Way," featuring the "Invis is for Kids" tagline to promote the Invisalign® Palatal Expander System [7](index=7&type=chunk) - On April 2, 2024, the Invisalign® Palatal Expander System received regulatory approval and launched in Australia and New Zealand, with expected rollout in other APAC markets starting in 2024 [7](index=7&type=chunk) - On January 31, 2024, Align launched the next generation of digital scanning technology, the iTero Lumina™ intraoral scanner [9](index=9&type=chunk) [Legal & Intellectual Property Milestones](index=3&type=section&id=Legal%20%26%20Intellectual%20Property%20Milestones) Align Technology won summary judgment in two US antitrust class action lawsuits and was recognized among the top 300 patent-issuing organizations - On February 22, 2024, the U.S. District Court for the Northern District of California ruled in favor of Align Technology in two U.S. antitrust class action lawsuits [8](index=8&type=chunk) - On January 31, 2024, Align Technology was included for the first time in the Intellectual Property Owners Association's annual report of the **top 300 organizations** granted U.S. patents [8](index=8&type=chunk) [Strategic Acquisitions](index=3&type=section&id=Strategic%20Acquisitions) Align Technology completed the acquisition of Cubicure GmbH, a pioneer in direct 3D printing solutions for polymer additive manufacturing - On January 2, 2024, Align completed the acquisition of Cubicure GmbH, a pioneer in direct 3D printing solutions for polymer additive manufacturing [9](index=9&type=chunk) [Stock Repurchase Program](index=3&type=section&id=Stock%20Repurchase%20Program) This section details Align Technology's recent stock repurchase activities and the remaining authorization under its current program [Stock Repurchase Program Details](index=3&type=section&id=Stock%20Repurchase%20Program%20Details) Align Technology repurchased approximately 1.1 million shares at an average price of $230.13, with $650 million remaining under the 2023 plan - Under the Q4'23 ASR contract, the company repurchased approximately **1.1 million shares** of common stock at an average price of **$230.13 per share** [10](index=10&type=chunk) - The January 2023 repurchase program still has **$650 million** available [10](index=10&type=chunk) - The company expects to repurchase up to **$150 million** of common stock in Q2'24 [10](index=10&type=chunk) [Business Outlook](index=3&type=section&id=Business%20Outlook) This section provides Align Technology's financial guidance and key operational expectations for the second quarter and full fiscal year 2024 [Second Quarter 2024 Outlook](index=4&type=section&id=Second%20Quarter%202024%20Outlook) Align Technology projects Q2 2024 global revenue between $1.03 billion and $1.05 billion, with Clear Aligner volume increasing sequentially Second Quarter 2024 Business Outlook | Metric | Outlook | | :--- | :--- | | Global Revenue | $1,030M - $1,050M | | Clear Aligner Volume | Sequential increase | | Clear Aligner ASP | Slight sequential decrease (primarily due to foreign exchange) | | Systems and Services Revenue | Sequential increase | | GAAP Operating Margin | Slightly above Q1'24 | | Non-GAAP Operating Margin | Slightly above Q1'24 | [Full Year 2024 Outlook](index=4&type=section&id=Full%20Year%202024%20Outlook) The company raised its full-year 2024 total revenue growth forecast to 6% to 8% year-over-year, with capital expenditures around $100 million Full Year 2024 Business Outlook | Metric | Outlook | | :--- | :--- | | Total Revenue Growth | Year-over-year +6% to +8% (up from prior "mid-single-digit growth" expectation) | | Clear Aligner ASP | Slight year-over-year increase | | GAAP Operating Margin | Slightly above 2023 | | Non-GAAP Operating Margin | Slightly above 2023 | | Capital Expenditures | Approximately $100M | - The incremental revenue growth is expected to be split evenly between the two operating segments [13](index=13&type=chunk) - Capital expenditures are primarily for building construction and improvements, and manufacturing capacity to support ongoing expansion [13](index=13&type=chunk) [Investor Information](index=5&type=section&id=Investor%20Information) This section provides details on Align Technology's investor webcast and clarifies the use of non-GAAP financial measures [Webcast and Conference Call Details](index=5&type=section&id=Webcast%20and%20Conference%20Call%20Details) Align Technology held a conference call and webcast on April 24, 2024, to review Q1 2024 results and discuss business outlook - The conference call and webcast were held on **April 24, 2024**, to review Q1'24 results and discuss the business outlook [15](index=15&type=chunk) - An archived audio webcast will be available within **2 hours** of the call's conclusion and will remain on the company's investor relations website for **one month** [15](index=15&type=chunk) [About Non-GAAP Financial Measures](index=5&type=section&id=About%20Non-GAAP%20Financial%20Measures) The company provides non-GAAP financial measures to supplement GAAP statements, excluding items like stock-based compensation and intangible asset amortization - Non-GAAP financial measures exclude stock-based compensation, amortization of certain acquired intangible assets, restructuring and other charges, acquisition-related costs, and related tax impacts [16](index=16&type=chunk) - Management believes non-GAAP measures provide meaningful supplemental information about core operating performance, aiding in performance evaluation, planning, forecasting, and analysis of future periods [17](index=17&type=chunk) - Non-GAAP financial measures are not a substitute for GAAP, and investors should review both GAAP and non-GAAP data along with their reconciliation tables [18](index=18&type=chunk) [About Align Technology](index=6&type=section&id=About%20Align%20Technology) This section offers a concise overview of Align Technology's core business, products, and market presence as a global medical device leader [Company Profile](index=6&type=section&id=Company%20Profile) Align Technology is a leading global medical device company, designing and manufacturing Invisalign® clear aligners, iTero™ scanners, and exocad™ CAD/CAM software - Align Technology designs and manufactures the Invisalign® system, iTero™ intraoral scanners, and exocad™ CAD/CAM software [19](index=19&type=chunk) - The company serves over **261,000 doctor customers** and has helped over **17.6 million patients** with the Invisalign system [19](index=19&type=chunk) - The Align Digital Platform™ is the company's integrated suite of proprietary technologies and services designed to improve patient outcomes and practice efficiency [19](index=19&type=chunk) [Forward-Looking Statements & Risk Factors](index=6&type=section&id=Forward-Looking%20Statements%20%26%20Risk%20Factors) This section highlights the forward-looking nature of the report's statements and outlines various risks that could impact Align Technology's future performance [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding future events, business growth, product launches, stock repurchase plans, and financial outlook - Forward-looking statements involve expectations for Q2'24 and full-year 2024 revenue, Clear Aligner volume, ASP, Systems and Services revenue, operating margins, and capital expenditures [21](index=21&type=chunk) - The company undertakes no obligation to publicly revise or update any forward-looking statements [24](index=24&type=chunk) [Risk Factors](index=6&type=section&id=Risk%20Factors) The company faces various risks including macroeconomic conditions, changes in customer behavior, increased competition, and supply chain disruptions - Risk factors include macroeconomic conditions (inflation, exchange rates, interest rates), changes in customer and consumer purchasing behavior, product mix shifts, competition, geopolitical conflicts, new product development and launch timing, supply chain disruptions, intellectual property protection, regulatory compliance, and loss of key personnel [22](index=22&type=chunk)[23](index=23&type=chunk) [Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents Align Technology's unaudited consolidated statements of operations, balance sheets, and cash flows for the reported periods [Statements of Operations](index=8&type=section&id=Statements%20of%20Operations) Align Technology reported Q1 2024 net revenue of $997.4 million, gross profit of $697.8 million, and net income of $105.0 million, showing year-over-year growth Summary of Statements of Operations Q1 2024 | Metric (Thousand USD) | March 31, 2024 | March 31, 2023 | | :--- | :--- | :--- | | Net Revenues | $997,431 | $943,147 | | Cost of Sales | $299,615 | $282,493 | | Gross Profit | $697,816 | $660,654 | | Selling, General and Administrative Expenses | $451,822 | $439,691 | | Research and Development Expenses | $91,859 | $87,447 | | Total Operating Expenses | $543,681 | $527,138 | | Income from Operations | $154,135 | $133,516 | | Income Before Income Taxes | $158,386 | $134,624 | | Income Tax Expense | $53,358 | $46,826 | | Net Income | $105,028 | $87,798 | | Diluted Net Income Per Share | $1.39 | $1.14 | [Balance Sheets](index=9&type=section&id=Balance%20Sheets) As of March 31, 2024, Align Technology's total assets were $6.156 billion, with a slight increase from December 31, 2023, driven by higher receivables and intangible assets Summary of Balance Sheets Q1 2024 | Metric (Thousand USD) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $865,805 | $937,438 | | Short-term marketable securities | $33,101 | $35,304 | | Accounts receivable, net | $950,738 | $903,424 | | Inventories | $280,076 | $296,902 | | Prepaid expenses and other current assets | $349,594 | $273,550 | | Total current assets | $2,479,314 | $2,446,618 | | Long-term marketable securities | $3,619 | $8,022 | | Property, plant and equipment, net | $1,281,709 | $1,290,863 | | Goodwill | $458,235 | $419,530 | | Intangible assets, net | $121,424 | $82,118 | | Deferred tax assets | $1,570,626 | $1,590,045 | | Total assets | $6,155,754 | $6,083,877 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $2,023,041 | $2,066,611 | | Total liabilities | $2,395,894 | $2,453,388 | | Total stockholders' equity | $3,759,860 | $3,630,489 | [Statements of Cash Flows](index=10&type=section&id=Statements%20of%20Cash%20Flows) In Q1 2024, Align Technology reported net cash inflow from operating activities of $28.66 million, with net cash outflows from investing and financing activities Summary of Statements of Cash Flows Q1 2024 | Metric (Thousand USD) | March 31, 2024 | March 31, 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $28,664 | $199,895 | | Net cash used in investing activities | ($79,584) | ($52,829) | | Net cash used in financing activities | ($11,716) | ($258,961) | | Effect of exchange rate changes on cash, cash equivalents and restricted cash | ($9,004) | $2,221 | | Net decrease in cash, cash equivalents and restricted cash | ($71,640) | ($109,674) | | Cash, cash equivalents and restricted cash at end of period | $866,879 | $832,681 | [Invisalign Business Metrics](index=11&type=section&id=Invisalign%20Business%20Metrics) This section provides key operational metrics for Align Technology's Invisalign business, including doctor training and utilization rates [Invisalign Key Metrics](index=11&type=section&id=Invisalign%20Key%20Metrics) In Q1 2024, Invisalign trained doctors totaled 83,510, with North America utilization at 9.5% and Clear Aligner revenue per case at $1,350 Invisalign Business Key Metrics | Metric | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Q1 2024 | | :--- | :--- | :--- | :--- | :--- | :--- | | Invisalign trained doctors | 82,730 | 83,440 | 85,195 | 83,700 | 83,510 | | North America utilization (%) | 9.5 | 9.8 | 9.6 | 9.1 | 9.5 | | North America Orthodontist utilization (%) | 28.7 | 29.2 | 28.8 | 25.9 | 28.2 | | North America GP Dentist utilization (%) | 4.9 | 5.2 | 4.9 | 5.0 | 4.9 | | International utilization (%) | 6.2 | 6.6 | 6.1 | 6.5 | 6.3 | | Total utilization (%) | 7.1 | 7.5 | 7.1 | 7.1 | 7.2 | | Clear Aligner revenue per case ($) | $1,335 | $1,335 | $1,320 | $1,320 | $1,350 | - Starting Q3 2023, Touch Up cases were included in case revenue, and prior period data was restated [34](index=34&type=chunk) [Stock-Based Compensation](index=11&type=section&id=Stock-Based%20Compensation) This section details Align Technology's stock-based compensation expenses allocated across cost of sales and operating expenses [Stock-Based Compensation Details](index=11&type=section&id=Stock-Based%20Compensation%20Details) In Q1 2024, Align Technology's total stock-based compensation was $38.788 million, with $2.064 million allocated to cost of sales Summary of Stock-Based Compensation | Metric (Thousand USD) | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Fiscal Year 2023 | Q1 2024 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | SBC included in cost of sales | $1,807 | $1,901 | $1,974 | $1,780 | $7,462 | $2,064 | | SBC included in operating expenses | $35,928 | $35,959 | $37,628 | $37,049 | $146,564 | $36,724 | | Total SBC | $37,735 | $37,860 | $39,602 | $38,829 | $154,026 | $38,788 | [GAAP to Non-GAAP Reconciliations](index=12&type=section&id=GAAP%20to%20Non-GAAP%20Reconciliations) This section provides detailed reconciliations of Align Technology's GAAP financial measures to non-GAAP measures, including constant currency adjustments [Constant Currency Net Revenues](index=12&type=section&id=Constant%20Currency%20Net%20Revenues) Q1 2024 GAAP net revenue was $997.4 million; constant currency net revenue was $987.5 million sequentially and $1.002 billion year-over-year Constant Currency Net Revenue Analysis (Sequential) | Metric (Thousand USD) | March 31, 2024 | December 31, 2023 | Revenue Impact (%) | | :--- | :--- | :--- | :--- | | GAAP Net Revenues | $997,431 | $956,726 | | | Constant currency impact | ($9,950) | | (1.0)% | | Constant currency net revenues | $987,481 | | | | GAAP Clear Aligner Net Revenues | $817,251 | $781,912 | | | Clear Aligner constant currency impact | ($8,421) | | (1.0)% | | Clear Aligner constant currency net revenues | $808,830 | | | | GAAP Imaging Systems and CAD/CAM Services Net Revenues | $180,180 | $174,814 | | | Imaging Systems and CAD/CAM Services constant currency impact | ($1,529) | | (0.9)% | | Imaging Systems and CAD/CAM Services constant currency net revenues | $178,651 | | | Constant Currency Net Revenue Analysis (Year-over-Year) | Metric (Thousand USD) | March 31, 2024 | March 31, 2023 | Revenue Impact (%) | | :--- | :--- | :--- | :--- | | GAAP Net Revenues | $997,431 | $943,147 | | | Constant currency impact | $4,823 | | 0.5% | | Constant currency net revenues | $1,002,254 | | | | GAAP Clear Aligner Net Revenues | $817,251 | $789,804 | | | Clear Aligner constant currency impact | $3,899 | | 0.5% | | Clear Aligner constant currency net revenues | $821,150 | | | | GAAP Imaging Systems and CAD/CAM Services Net Revenues | $180,180 | $153,343 | | | Imaging Systems and CAD/CAM Services constant currency impact | $924 | | 0.5% | | Imaging Systems and CAD/CAM Services constant currency net revenues | $181,104 | | | [Constant Currency Gross Profit and Gross Margin](index=14&type=section&id=Constant%20Currency%20Gross%20Profit%20and%20Gross%20Margin) Q1 2024 GAAP gross profit was $697.8 million with a 70.0% margin; constant currency gross profit was $687.9 million sequentially and $702.6 million year-over-year Constant Currency Gross Profit and Gross Margin Analysis (Sequential) | Metric (Thousand USD) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | GAAP Gross Profit | $697,816 | $669,524 | | Net revenue constant currency impact | ($9,950) | | | Constant currency gross profit | $687,866 | | | GAAP Gross Margin (%) | 70.0% | 70.0% | | Gross margin constant currency impact (%) | (0.3) | | | Constant currency gross margin (%) | 69.7% | | Constant Currency Gross Profit and Gross Margin Analysis (Year-over-Year) | Metric (Thousand USD) | March 31, 2024 | March 31, 2023 | | :--- | :--- | :--- | | GAAP Gross Profit | $697,816 | $660,654 | | Net revenue constant currency impact | $4,823 | | | Constant currency gross profit | $702,639 | | | GAAP Gross Margin (%) | 70.0% | 70.0% | | Gross margin constant currency impact (%) | 0.1 | | | Constant currency gross margin (%) | 70.1% | | [Constant Currency Income from Operations and Operating Margin](index=15&type=section&id=Constant%20Currency%20Income%20from%20Operations%20and%20Operating%20Margin) Q1 2024 GAAP operating income was $154.1 million with a 15.5% margin; constant currency operating income was $151.1 million sequentially and $161.9 million year-over-year Constant Currency Income from Operations and Operating Margin Analysis (Sequential) | Metric (Thousand USD) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | GAAP Income from Operations | $154,135 | $171,545 | | Income from operations constant currency impact | ($3,015) | | | Constant currency income from operations | $151,120 | | | GAAP Operating Margin (%) | 15.5% | 17.9% | | Operating margin constant currency impact (%) | (0.1) | | | Constant currency operating margin (%) | 15.3% | | Constant Currency Income from Operations and Operating Margin Analysis (Year-over-Year) | Metric (Thousand USD) | March 31, 2024 | March 31, 2023 | | :--- | :--- | :--- | | GAAP Income from Operations | $154,135 | $133,516 | | Income from operations constant currency impact | $7,802 | | | Constant currency income from operations | $161,937 | | | GAAP Operating Margin (%) | 15.5% | 14.2% | | Operating margin constant currency impact (%) | 0.7 | | | Constant currency operating margin (%) | 16.2% | | [Financial Measures Other Than Constant Currency](index=17&type=section&id=Financial%20Measures%20Other%20Than%20Constant%20Currency) Q1 2024 non-GAAP gross profit was $703.6 million with a 70.5% margin, and non-GAAP diluted EPS was $2.14, adjusted for specific non-operating items Summary of Non-GAAP Financial Measures Reconciliation | Metric (Thousand USD) | March 31, 2024 | March 31, 2023 | | :--- | :--- | :--- | | GAAP Gross Profit | $697,816 | $660,654 | | Stock-based compensation | $2,064 | $1,807 | | Amortization of intangible assets | $3,724 | $2,774 | | Non-GAAP Gross Profit | $703,604 | $665,227 | | GAAP Gross Margin (%) | 70.0% | 70.0% | | Non-GAAP Gross Margin (%) | 70.5% | 70.5% | | GAAP Total Operating Expenses | $543,681 | $527,138 | | Non-GAAP Total Operating Expenses | $506,094 | $490,520 | | GAAP Income from Operations | $154,135 | $133,516 | | Stock-based compensation | $38,788 | $37,735 | | Amortization of intangible assets | $4,587 | $3,641 | | Non-GAAP Income from Operations | $197,510 | $174,707 | | GAAP Operating Margin (%) | 15.5% | 14.2% | | Non-GAAP Operating Margin (%) | 19.8% | 18.5% | | GAAP Net Income | $105,028 | $87,798 | | Non-GAAP Net Income | $161,439 | $140,615 | | GAAP Diluted Net Income Per Share | $1.39 | $1.14 | | Non-GAAP Diluted Net Income Per Share | $2.14 | $1.82 | - Non-GAAP adjustments include stock-based compensation, amortization of certain acquired intangible assets, and restructuring and other charges [57](index=57&type=chunk) - The non-GAAP effective tax rate for Q1 2024 was **20.0%**, consistent with the prior year period [57](index=57&type=chunk) [Outlook - GAAP to Non-GAAP Reconciliation](index=20&type=section&id=Outlook%20-%20GAAP%20to%20Non-GAAP%20Reconciliation) This section presents the reconciliation of Align Technology's GAAP and non-GAAP operating margin outlook for Q2 and full fiscal year 2024 [Q2 2024 Outlook](index=20&type=section&id=Q2%202024%20Outlook) Align Technology forecasts Q2 2024 GAAP operating margin slightly above 15.5% and non-GAAP operating margin slightly above 19.8% Second Quarter 2024 Operating Margin Outlook | Metric | Outlook | | :--- | :--- | | GAAP Operating Margin (%) | Slightly above 15.5% | | Stock-based compensation (%) | ~4.0% | | Amortization of intangible assets (%) | ~0.4% | | Non-GAAP Operating Margin (%) | Slightly above 19.8% | [Fiscal 2024 Outlook](index=20&type=section&id=Fiscal%202024%20Outlook) Align Technology projects full-year 2024 GAAP operating margin slightly above 16.7% and non-GAAP operating margin slightly above 21.4% Fiscal Year 2024 Operating Margin Outlook | Metric | Outlook | | :--- | :--- | | GAAP Operating Margin (%) | Slightly above 16.7% | | Stock-based compensation (%) | ~4.4% | | Amortization of intangible assets (%) | ~0.4% | | Non-GAAP Operating Margin (%) | Slightly above 21.4% |