Core Viewpoint - Edwards Lifesciences continues to showcase its commitment to the structural heart disease field by participating in the China International Import Expo for the sixth consecutive year, highlighting its innovative products and treatment solutions [1] Group 1: Product Launch and Innovation - Edwards Lifesciences presented the PASCAL Precision transcatheter valve repair system, marking its debut at the expo following its launch in Hong Kong [1] - The PASCAL Precision system offers a minimally invasive and reliable intervention option for high-risk surgical patients with mitral and tricuspid regurgitation, with expectations for approval in mainland China next year [1] Group 2: Strategic Partnerships - Edwards has upgraded its strategic collaborations with key industry partners such as Sinopharm Group and Shanghai Pharmaceuticals, aiming to enhance the introduction of advanced technologies and clinical transformation [1] - Wayne Markowitz, Global Vice President for Japan and Asia Pacific, emphasized the company's patient-first philosophy and the importance of the expo as a platform for collaboration [1] Group 3: Market Expansion - The participation in the expo signifies Edwards' efforts to accelerate the extension of its innovative achievements in transcatheter valve repair to the Chinese market [1] - The company aims to leverage the expo as an open window for accelerating the introduction of cutting-edge technologies [1]

Financial Performance - Net sales for the first nine months of 2025 were $4.5 billion, an increase of $444.3 million or 11.0% compared to the same period in 2024, primarily driven by TAVR and TMTT product sales [145]. - Gross profit increased in the nine months ended September 30, 2025, but as a percentage of sales decreased due to foreign currency fluctuations and higher operational expenses [146]. - Net sales in the United States for the three months ended September 30, 2025, were $907.5 million, a 12.8% increase from $804.6 million in 2024 [150]. - TAVR product sales for the three months ended September 30, 2025, were $1,149.9 million, a 12.4% increase from $1,023.3 million in 2024 [151]. - TMTT product sales increased by 59.3% for the three months ended September 30, 2025, reaching $145.2 million compared to $91.1 million in 2024 [151]. Expenses - SG&A expenses increased due to higher personnel-related costs and performance-based compensation, with foreign currency fluctuations adding $7.3 million to expenses for the three months ended September 30, 2025 [172]. - R&D expenses increased due to heightened clinical activity related to heart failure management innovations [175]. Taxation - The effective income tax rate for the nine months ended September 30, 2025, was 16.1%, up from 9.2% in 2024, primarily due to global minimum tax increases and reduced tax benefits from employee share-based compensation [183]. - The company expects an additional tax expense of approximately $50 million in 2025 due to the implementation of the OECD's Pillar Two rules, which impose a global minimum tax of 15% on reported profits [184]. - The IRS proposed a substantial increase to the company's taxable income for the 2015 through 2017 tax years, potentially resulting in an additional tax expense of approximately $255 million [188]. - The company plans to contest the IRS's claim for an additional tax of $269.3 million for the 2015 through 2017 tax years through the judicial process [189]. Cash and Investments - As of September 30, 2025, the company had cash and cash equivalents of $3.4 billion in the United States and $438.0 million outside the United States [196]. - The company had $1,223.2 million in investments in debt securities and $207.9 million in investments in equity instruments as of September 30, 2025, exposing it to investment risks [211]. Shareholder Actions - The company repurchased 11.2 million shares at an aggregate cost of $844.9 million during the nine months ended September 30, 2025, with remaining authority to purchase $2.1 billion of common stock [199]. Acquisitions and Divestitures - The company entered into a definitive agreement to sell a non-core product group for $85 million, with additional earnouts of up to $40 million expected to close in Q4 2025 [141]. - The company entered into agreements to acquire multiple medical device companies for a total cash purchase price of $1.5 billion, with three transactions closed in 2024 for $1.1 billion [200]. Cash Flow - Net cash flows provided by operating activities increased by $474.5 million to $1,144.3 million for the nine months ended September 30, 2025, primarily due to lower tax payments and improved operating performance [204]. - Net cash used in investing activities was $514.6 million for the nine months ended September 30, 2025, primarily due to net purchases of investments and capital expenditures [205]. - Net cash used in financing activities was $945.4 million for the nine months ended September 30, 2025, primarily due to purchases of treasury stock [207]. Regulatory Approvals - The company received FDA approval for the SAPIEN 3 platform for severe aortic stenosis patients without symptoms in April 2025 [155].

Core Insights - Investors in Edwards Lifesciences Corporation should monitor stock movements due to high implied volatility in the options market, particularly the Nov. 21, 2025 $50 Put option [1] Company Overview - Edwards Lifesciences is currently rated as Zacks Rank 3 (Hold) in the Medical – Instruments industry, which ranks in the top 37% of the Zacks Industry Rank [3] - Over the last 60 days, seven analysts have raised their earnings estimates for the current quarter, resulting in an increase of the Zacks Consensus Estimate from 59 cents per share to 61 cents [3] Market Sentiment - The high implied volatility suggests that options traders are anticipating significant price movement for Edwards Lifesciences shares, indicating potential trading opportunities [4] - Seasoned options traders often seek high implied volatility options to sell premium, aiming for the underlying stock to not move as much as expected at expiration [4]

Core Viewpoint - Investors should closely monitor Edwards Lifesciences Corporation (EW) stock due to significant implied volatility in the options market, particularly for the Nov 21, 2025 $50.00 Put option [1] Company Analysis - Edwards Lifesciences is currently rated as Zacks Rank 3 (Hold) in the Medical - Instruments industry, which ranks in the top 37% of the Zacks Industry Rank [3] - Over the last 60 days, seven analysts have raised their earnings estimates for the current quarter, resulting in an increase of the Zacks Consensus Estimate from earnings of 59 cents per share to 61 cents per share [3] Options Market Insights - The high implied volatility suggests that options traders are anticipating a significant price movement for Edwards Lifesciences shares, potentially indicating an upcoming event that could lead to a major rally or sell-off [2][4] - Options traders often seek to sell premium on options with high implied volatility, aiming to benefit from the decay of the option's value if the underlying stock does not move as much as expected [4]

Industry Overview - The global population is aging rapidly, with the number of individuals aged 60 and above surpassing those under five for the first time in 2020, leading to significant implications for healthcare systems and investors [2] - By 2050, nearly 22% of the global population will be over 60, with a significant concentration in low- and middle-income countries [2] - The geriatric care services industry is currently valued at approximately $1.21 trillion and is projected to grow to around $2.12 trillion by 2034, reflecting a compound annual growth rate (CAGR) of 6.4% [3] Market Dynamics - Evolving healthcare utilization patterns due to aging are creating growth opportunities in senior living communities, skilled nursing facilities, assisted living, and post-acute care providers [4] - The Centers for Medicare & Medicaid Services (CMS) has advanced the Program of All-Inclusive Care for the Elderly (PACE), aimed at providing comprehensive care for seniors [4] Key Players - Major healthcare companies like Boston Scientific, AbbVie, Amgen, and Edwards Lifesciences are actively expanding their presence in the senior and aging demographics [5] - The Ensign Group is expanding its skilled nursing and rehabilitative services, supported by a decentralized management strategy [7] - Healthcare real estate investment trusts (REITs) such as Omega Healthcare Investors and CareTrust REIT are focusing on skilled nursing and senior housing properties [7] Investment Perspective - The senior-care services sector is resilient during economic downturns, providing stable cash flows and making it attractive for long-term investors seeking defensive growth [8] Company Highlights - **Boston Scientific**: Focuses on medical devices for the elderly, including the WATCHMAN device for stroke risk reduction and the SYNERGY bioabsorbable stent system [9][10] - **AbbVie**: Expanding its focus on the aging demographic through strategic partnerships, including the acquisition of Aliada Therapeutics for Alzheimer's treatment [11][12][14] - **Amgen**: Targeting the aging population with innovations in biopharma, including obesity treatments and bone health therapies [15][16] - **Edwards Lifesciences**: Advancing care for aortic stenosis in elderly patients, with significant sales growth in structural-heart solutions [17][18][19]

Core Insights - Edwards Lifesciences has raised its 2025 sales outlook, driven by strong performance in its transcatheter heart-valve replacement (TAVR) business, which saw over 12% growth to $1.15 billion, surpassing expectations of $1.1 billion [1][2][5] Financial Performance - The company reported adjusted earnings of 67 cents per share on sales of $1.55 billion for Q3, with earnings rising 12% and sales climbing nearly 15%, both exceeding forecasts of 60 cents and $1.5 billion respectively [5][7] - Revenue from the nonsurgical replacement of mitral and tricuspid valves (TMTT) surged over 59% to $145.2 million, outperforming analyst projections of $142.1 million [6] Future Outlook - Edwards anticipates sales growth at the high end of the 9% to 10% range and projects adjusted profit of $2.56 to $2.62 per share, which is an increase of 9 cents from previous guidance [7] - Analysts expect earnings per share of $2.51 and total sales of $5.98 billion [7] Management Changes - The Chief Financial Officer, Scott Ullem, will transition from his role by mid-2026, prompting a selection process for a new CFO [8]

Core Insights - The China International Import Expo (CIIE) serves as a vital platform for global innovation to enter the Chinese market, with companies like Edwards Lifesciences leveraging it to enhance local partnerships and accelerate the clinical application of innovative medical technologies [1][2] - Edwards has witnessed significant growth in the Chinese medical industry over the past 25 years, benefiting from an improved business environment and innovative regulatory breakthroughs [1] - The company plans to expand its local collaboration network and deepen partnerships with clinical experts to enhance the treatment of structural heart diseases in China [1] Company Highlights - Edwards Lifesciences has successfully transitioned multiple innovative products from exhibition to clinical application, including the INSPIRIS RESILIA valve launched in 2021 and the SAPIEN3 Ultra RESILIA valve, which debuted at the 2023 CIIE [1] - The MITRIS RESILIA valve was officially launched in China in April 2023, showcasing the rapid commercialization of products introduced at the expo [1] - The PASCAL Precision transcatheter valve repair system made its debut at the CIIE after being launched in Hong Kong [1] Other Company Activities - This year marks the sixth consecutive participation of Edwards at the CIIE, where it showcases a full range of cutting-edge products and treatment solutions, including an interactive experience area for participants [2] - AstraZeneca, Novo Nordisk, and Intuitive Surgical are also notable participants, with AstraZeneca planning to announce a new production expansion plan and showcasing over 40 innovative drugs [2] - Novo Nordisk is focusing on obesity management with an immersive experience space, highlighting the importance of public awareness regarding obesity [2] Product Innovations - Novo Nordisk will present advancements in its "semaglutide family" of products, including the approval of new indications for chronic kidney disease and the introduction of oral formulations [3] - Intuitive Surgical will showcase its da Vinci surgical robots, emphasizing its commitment to innovation in medical technology and the Chinese market [3] - The company aims to build a comprehensive training system for hospitals and doctors to enhance their skills in robotic surgery [3]

Financial Data and Key Metrics Changes - Sales in Q3 2025 grew 12.6% to $1.55 billion, leading to an increase in full-year sales growth guidance to the high end of the previous 9% to 10% range [5][27] - Adjusted earnings per share (EPS) for Q3 was $0.67, exceeding expectations, while GAAP EPS was $0.50 [22][27] - Adjusted gross profit margin was 77.9%, down from 80.7% year-over-year, primarily due to foreign exchange and operational expenses [23] Business Line Data and Key Metrics Changes - TAVR global sales reached $1.15 billion, a 10.6% increase year-over-year, driven by renewed clinician focus on aortic stenosis treatment [13][14] - TMTT product group sales were $144 million, up 53% year-over-year, fueled by strong performance of Pascal and EVOKE [17] - Surgical product group sales were $258 million, increasing 5.6% year-over-year, supported by the adoption of Resilia therapies [20] Market Data and Key Metrics Changes - TAVR growth was supported by new evidence, guideline updates, and expanded education, with strong procedure growth in the U.S. and Europe [14][16] - In Japan, TAVR sales growth improved, reflecting a gradual recovery in market growth [16] - The global market for TMTT is expected to grow to an estimated $2 billion by 2030 [12] Company Strategy and Development Direction - The company is focused on structural heart therapies, positioning itself for sustainable multi-year growth [6][12] - There is a commitment to expanding into heart failure and aortic regurgitation as next-generation contributors to patient impact and growth [12][30] - The company plans to discuss long-term financial goals and market potential at the upcoming investor conference in December [27][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing strong Q3 performance and multiple growth drivers [5][6] - The management highlighted the importance of recent clinical data and guideline changes in driving TAVR adoption [14][37] - There is optimism regarding the upcoming approval of SAPIEN M3 in the U.S. by early 2026, which is expected to enhance treatment options for mitral patients [20][46] Other Important Information - The company has approximately $3 billion in cash and cash equivalents, with a share repurchase authorization of about $2 billion remaining [25] - The CFO announced plans to transition out of the role by mid-2026, with a succession plan in place [27][29] Q&A Session Summary Question: What drove the strength in TAVR growth this quarter? - Management attributed the strong performance to renewed focus on TAVR, new evidence, and a lack of typical summer seasonality [32][33] Question: How does the recent TCT data impact physician practices? - The data presented at TCT reassured physicians about TAVR's long-term performance, encouraging earlier treatment in the disease progression pathway [36][37] Question: What is the outlook for TAVR growth excluding Boston Scientific's exit? - Management indicated that while the growth was strong, it should not be considered the new normal, and they expect continued good performance in Q4 [32][33] Question: How does the company view the potential for broader diagnostic rates for AS? - Management sees the recent studies validating the market potential for AS as positive, suggesting that greater awareness and referral could lead to increased adoption [43][44] Question: What is the expected impact of FX on margins next year? - Management stated that they would provide detailed guidance on FX impacts at the upcoming investor conference [40] Question: What are the expectations for the SAPIEN M3 launch compared to EVOQUE? - The SAPIEN M3 launch is being approached with a controlled strategy, focusing on training and ensuring optimal outcomes before broader adoption [46][47]

Core Insights - Edwards Lifesciences exceeded Wall Street expectations for third-quarter results, primarily due to robust demand for its artificial heart valves and other medical devices [1] Financial Performance - The company reported strong sales growth, contributing to a rise in share prices by approximately 3% following the announcement [1]

Core Insights - Edwards Lifesciences announced that its Chief Financial Officer, Scott Ullem, will resign by mid-2026 and will continue in an advisory capacity until a successor is appointed [1] Company Summary - The company is undergoing a leadership transition with the planned departure of its CFO [1] - Scott Ullem's advisory role indicates a structured transition process to ensure continuity in financial leadership [1]