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A month has gone by since the last earnings report for Align Technology (ALGN) . Shares have lost about 21.2% in that time frame, underperforming the S&P 500.Will the recent negative trend continue leading up to its next earnings release, or is Align Technology due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts. ALGN Q4 Earnings Top Estimates, Revenue ...

Core Viewpoint - Align Technology (NASDAQ: ALGN) is currently undervalued, with a scenario presented where the business does not grow over the next five years and experiences a decrease in Adjusted EBIT Margins by 50 basis points, yet still arrives at the current share price [1] Company Analysis - The analysis suggests that Align Technology possesses durable competitive advantages and holds a significant moat over its industry, making it an attractive investment opportunity [1] - A discounted cash flow (DCF) approach is utilized for valuation, using historical data as a benchmark to generate forecasts [1]

Company Developments - Align Technology, Inc. has announced the addition of restorative capabilities to its next-generation iTero Lumina intraoral scanner and the new iTero Lumina Pro dental imaging system [1][2] - The enhancements aim to improve restorative workflows and support diagnostics of interproximal caries, thereby increasing practice efficiency for general practitioner dentists [2] - Current iTero Lumina scanner owners will receive new software updates with restorative and diagnostic support starting in April, following regulatory clearance [7] Market Performance - Following the announcement, Align Technology's shares increased by 0.6% to $173 [3] - The company currently has a market capitalization of $12.66 billion, with projected earnings growth of 6.6% in 2025 driven by a 2.3% increase in revenues [4] - In the past month, Align Technology's shares have declined by 44.6%, contrasting with a 3% decline in the industry [10] Industry Prospects - The global intraoral scanners market was valued at $969.4 million in 2023 and is expected to reach $2,816.4 million by 2035, growing at a compound annual growth rate (CAGR) of 9.3% from 2024 to 2035 [8] - Market growth is attributed to advancements in digital dentistry, increased awareness of oral health, and greater adoption in orthodontics, prosthodontics, and restorative dentistry [8] Product Features - The iTero Lumina solutions offer up to five capabilities in one device, designed to reduce maintenance time and costs while automating daily tasks [5] - These solutions provide predictable and repeatable restoration fits, enhancing patient experience with quick and comfortable scanning [6]

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].

Dallas, Texas, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Healthcare Finance Direct (HFD), a leading provider of patient financing solutions, is thrilled to announce it is a preferred financing partner of Align Technology, Inc. (NASDAQ:ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry. Align US customers electing to participate will ha ...

Company Developments - Align Technology, Inc. has launched its Invisalign Palatal Expander System in Turkey after receiving approval from the Turkish Medicines and Medical Device Agency, which allows for broad patient applicability including children, teens, and adults [1] - The Invisalign Palatal Expander System is a modern 3D-printed device designed for rapid expansion of the upper jaw during orthodontic treatment, utilizing proprietary technology [4][5] - The system is currently available in multiple markets including the United States, Canada, and the European Union, with plans for further expansion pending regulatory approvals [7][11] Financial Performance - Align Technology has a market capitalization of $15.72 billion, with projected earnings growth of 7.9% in 2024 driven by a 3.9% increase in revenues [3] - The company has demonstrated a trailing four-quarter average earnings surprise of 6.18% [3] - Following the recent product launch, ALGN shares increased by 0.7% to $212.03, indicating a positive market sentiment [2] Industry Context - The global 3D printing market was valued at $3.1 billion in 2023 and is expected to grow at a compound annual growth rate of 26.4% through 2030, highlighting the potential for growth in 3D printing dentistry [10] - Align Technology's offerings, including the Invisalign Palatal Expander System, position the company favorably within the rapidly evolving orthodontics market [8]

Core Insights - Align Technology, Inc. (ALGN) reported fourth-quarter 2024 adjusted earnings per share (EPS) of $2.44, a 0.8% increase year-over-year, surpassing the Zacks Consensus Estimate by 0.4% [1][2] - The company's GAAP EPS for the quarter was $1.39, reflecting a 15.2% decline from $1.64 in the same period of 2023 [2] - Full-year adjusted EPS reached $9.33, an 8.4% increase from 2023, also exceeding the Zacks Consensus Estimate by 0.1% [2] Revenue Performance - Q4 revenues increased by 4% year-over-year to $995.2 million, but fell short of the Zacks Consensus Estimate by 0.2% [3] - Full-year revenues totaled $4.00 billion, marking a 3.5% increase from 2023, aligning with the Zacks Consensus Estimate [3] Segment Analysis - Clear Aligner segment revenues rose 1.6% year-over-year to $794.3 million, with a minor unfavorable foreign exchange impact of 0.1% [4] - Imaging Systems & CAD/CAM Services revenues surged 14.9% to $200.9 million, also experiencing a 0.1% unfavorable currency impact [4] Margin and Expense Overview - Gross profit for the quarter was $696.9 million, up 4.1% year-over-year, with a gross margin of 70%, expanding by 5 basis points [5] - SG&A expenses increased by 5.6% to $425 million, while R&D expenses rose 15.5% to $94.9 million [5] - Operating income totaled $177.1 million, down 4.2% year-over-year, with an operating margin contraction of 153 basis points to 17.8% [5] Financial Position - At the end of Q4, cash and cash equivalents stood at $1.04 billion, up from $937.4 million at the end of Q4 2023 [6] - Cumulative net cash provided by operating activities was $738.2 million, down from $785.8 million at the end of 2023 [6] Stock Repurchase Program - ALGN has $225 million available for repurchases under its $1.0 billion Stock Repurchase Program, authorized in January 2023 [7] Future Guidance - For full-year 2025, ALGN expects low single-digit revenue growth, indicating approximately 2% unfavorable foreign exchange impact [8] - The Zacks Consensus Estimate for 2025 revenues is $4.19 billion, suggesting a 4.8% year-over-year growth [8] - The anticipated GAAP operating margin for 2025 is expected to be slightly above the 2024 level, with a non-GAAP operating margin forecasted at approximately 22.5% [9] Q1 2025 Expectations - For Q1 2025, ALGN projects worldwide revenues between $965 million and $985 million, while the Zacks Consensus Estimate is $1.02 billion [10] Overall Assessment - Align Technology's Q4 results were mixed, with earnings exceeding estimates but revenues falling short [11] - Revenue growth was driven by increased volumes in Clear Aligner and Imaging Systems & CAD/CAM Services [11] - Clear Aligner volume growth was supported by higher shipments across all operational regions, particularly in the EMEA region [12] - The Imaging Systems & CAD/CAM Services segment saw strong growth due to higher average selling prices and improved service revenues [13] - The company achieved significant milestones, including 271.6 thousand active Invisalign-trained practitioners and over 2 billion clear aligners manufactured [14]

Core Insights - Align Technology reported Q4 2024 earnings that closely matched expectations, with a focus on international growth despite currency challenges [2][7] - The company aims for low single-digit revenue growth in fiscal 2025, with mid-single-digit growth projected for Clear Aligner volumes [9] Financial Performance - Non-GAAP EPS for Q4 2024 was $2.44, slightly below the expected $2.45, while revenue reached $995.2 million, just under the anticipated $996 million [2][3] - Year-over-year revenue growth was 4.0%, up from $956.7 million in Q4 2023, and Clear Aligner volume increased by 6.1% to 628,730 units [3][6] - Operating margin (Non-GAAP) decreased to 23.2%, down 0.6 percentage points from the previous year [3] Business Overview - Align Technology is a leader in digital orthodontics, primarily known for its Invisalign clear aligners, which offer an alternative to traditional braces [4] - The company utilizes advanced technologies, including iTero intraoral scanners and CAD/CAM software, to enhance treatment planning and monitoring [4] Strategic Focus - The company is concentrating on international market expansion and product innovation, leveraging 3D printing for scalable production [5] - Align Digital Platform is a key component of its strategy to support growth in both emerging and established markets [5] Market Dynamics - Revenue from systems and services grew by 14.9% compared to Q4 2023, indicating strong consumer interest and market penetration [7] - The stronger U.S. dollar negatively impacted net income per share by approximately $0.14, and decreased demand in the U.S. market affected Clear Aligner sales [7] Operational Metrics - Despite challenges from currency fluctuations and restructuring charges, Align Technology maintained a strong cash position of approximately $1.044 billion after stock repurchases of $275 million in 2024 [8]

Core Insights - Align Technology reported revenue of $995.22 million for the quarter ended December 2024, reflecting a 4% increase year-over-year [1] - The earnings per share (EPS) for the quarter was $2.44, slightly up from $2.42 in the same quarter last year [1] - The revenue fell short of the Zacks Consensus Estimate by -0.18%, while the EPS exceeded the consensus estimate by +0.41% [1] Financial Performance Metrics - Clear Aligner shipments were reported at 629, slightly above the estimated average of 623 [4] - Net revenues from Imaging Systems and CAD/CAM Services reached $200.93 million, surpassing the average estimate of $199.65 million, marking a year-over-year increase of +14.9% [4] - Total net revenues from Clear Aligners were $794.29 million, which was below the average estimate of $801.13 million, but still represented a year-over-year growth of +1.6% [4] Market Performance - Align Technology's shares have returned -1.3% over the past month, contrasting with the Zacks S&P 500 composite's +1.7% change [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]