Core Insights - Edwards Lifesciences Corporation reported fourth-quarter 2025 adjusted earnings per share (EPS) of 58 cents, missing the Zacks Consensus Estimate by 5.89% and reflecting a 1.7% year-over-year decline [1] - Full-year adjusted EPS was $2.56, a 5.3% increase from 2024, but also missed the Zacks Consensus Estimate by 1.2% [2] Revenue Performance - Total sales for the fourth quarter reached $1.57 billion, marking a 13.3% year-over-year increase and surpassing the Zacks Consensus Estimate by 1.99% [3] - Full-year revenues for 2025 amounted to $6.07 billion, up 11.5% year over year, also beating the Zacks Consensus Estimate by 0.7% [3] Segment Sales Analysis - Transcatheter Aortic Valve Replacement (TAVR) sales were $1.16 billion, up 12% year over year, driven by increased focus on SAPIEN therapy [4] - Transcatheter Mitral and Tricuspid Therapies (TMTT) sales reached $155.7 million, a significant 48.3% increase from the prior year, exceeding projections [5] - Surgical Structural Heart sales totaled $253.6 million, reflecting a 3.8% year-over-year growth despite some inventory adjustments [6] Margin and Cost Analysis - Gross profit was $1.22 billion, a 12.2% increase year over year, but gross margin contracted by 77 basis points to 78.2% due to a 17.4% rise in cost of sales [7] - Selling, General and Administrative (SG&A) expenses rose 22.6% year over year to $602.9 million, while R&D expenditures decreased by 1.3% to $267.7 million [7] Future Guidance - For 2026, the company projects sales growth of 8% to 10%, with adjusted EPS expected in the range of $2.90 to $3.05 [11] - The first quarter of 2026 is projected to have total sales between $1.55 billion and $1.63 billion, with adjusted EPS in the range of 70 to 76 cents [12] Overall Performance Summary - Despite an earnings miss, Edwards Lifesciences experienced revenue growth and expressed confidence in its 2026 outlook, supported by strong quarterly performance and ongoing adoption of its therapies [13]

Core Insights - Edwards Lifesciences reported over $6 billion in revenue for the full year 2025, primarily driven by strong demand for its transcatheter aortic valve replacement (TAVR) products and a 56.4% growth in its transcatheter mitral and tricuspid therapies (TMTT) portfolio, despite missing analysts' earnings per share (EPS) estimates in Q4 [1][2][7] Revenue Performance - The revenue for 2025 reflects an 11.5% increase compared to 2024, with Q4 2025 revenue reaching $1.56 billion, marking a 13.3% rise from Q4 2024 [2] - The TAVR portfolio contributed $4.49 billion to total revenue in 2025, a 9.3% increase from $4.10 billion in 2024 [3] - TMTT revenue grew 56.4% to $550.6 million in 2025, up from $352.1 million in 2024 [4] - The surgical structural heart portfolio surpassed $1 billion in revenue for 2025, generating $253.6 million in Q4, with year-over-year increases of 4.9% and 3.8% respectively [5] Market Reaction - Following the financial results released after market close on February 10, the company's shares rose by 3% in after-hours trading on the New York Stock Exchange (NYSE) [3] Future Guidance - Edwards expects 2026 earnings to be in the range of $2.90 to $3.05 per share, with revenue growth guidance set between 8% and 10% at constant currency [2] - CEO Bernard Zovighian emphasized significant advancements in TMTT therapies, including the launch of SAPIEN M3 and the scaling of EVOQUE, with a revenue expectation of $2 billion for TMTT by 2030 [4][5] Earnings Analysis - Total Q4 revenue was $1.56 billion, with the TAVR portfolio accounting for $1.16 billion, a 12% increase from approximately $1 billion in Q4 2024, exceeding analysts' estimates of $1.13 billion [6] - Adjusted EPS for Q4 was $0.58, falling short of the $0.62 estimate, attributed to a deliberate increase in spending ahead of improving TAVR guidelines and potential expanded reimbursement in 2026 [7]

Financial Data and Key Metrics Changes - The company reported total sales of $1.57 billion for Q4 2025, reflecting an 11.6% year-over-year growth, and a full-year growth of 10.7% [5][22] - Adjusted earnings per share (EPS) for Q4 was $0.58, while GAAP EPS was $0.11, impacted by one-time charges related to the JenaValve acquisition and litigation expenses [22][24] - The adjusted gross profit margin for Q4 was 78.3%, slightly down from 79.0% in the previous year, attributed to increased manufacturing expenses [23][24] Business Line Data and Key Metrics Changes - TAVR global sales reached $1.16 billion in Q4, increasing by 10.6% year-over-year, with procedural growth in the high single digits [10][11] - TMTT sales grew over 40% to $156 million in Q4, with full-year sales exceeding $1 billion [16] - Surgical product group sales for Q4 were $254 million, a 2% increase year-over-year, with full-year sales surpassing $1 billion [18] Market Data and Key Metrics Changes - The U.S. and international markets showed comparable TAVR procedural growth, with stable average pricing and competitive positioning globally [11][15] - In Europe, TAVR results reflected healthy underlying procedural growth, supported by updated clinical guidelines [14][15] Company Strategy and Development Direction - The company focuses solely on Structural Heart, aiming to solve complex patient needs and innovate within the market [5][9] - Plans to pioneer new therapies and expand indications over the next three years, with a long-term sales growth expectation of 10% annually [10][29] - The company is investing in patient access initiatives and partnerships, such as with the American Heart Association, to enhance treatment awareness [14][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting 2026 sales growth guidance of 8%-10% and EPS guidance of $2.90-$3.05, citing strong Q4 performance as a foundation [22][27] - The company anticipates a potential tailwind from an updated national coverage determination for TAVR later in the year [8][50] - Management highlighted the importance of timely and equitable access to care for patients, particularly in light of new clinical guidelines [12][76] Other Important Information - The company maintains a strong balance sheet with approximately $3 billion in cash and cash equivalents as of December 31 [25] - The company has about $2 billion remaining under its share repurchase authorization, with plans to continue repurchasing shares opportunistically [26][70] Q&A Session Summary Question: Insights on TAVR growth and market share - Management noted that TAVR grew 10.6% year-over-year, driven by compelling clinical evidence and a renewed focus on proactive treatment [34][35] Question: Increased spending on market access initiatives - The company increased SG&A spending by $112 million year-over-year to support strategic investments in patient access and education [39][40] Question: TAVR NCD and its potential impact - Management indicated that the reopening of the TAVR NCD process is crucial for improving patient access, with a draft expected around June [50][51] Question: LAA market opportunity and differentiation - The company sees significant unmet needs in the LAA market and plans to introduce differentiated technology to address these needs [52][56] Question: Comments on guideline changes in Europe - Management highlighted the shift in European guidelines towards proactive disease management, which is expected to drive procedural growth [76][77]

Financial Data and Key Metrics Changes - The company reported a strong fourth quarter growth of 11.6% and a full year growth of 10.7% for 2025, driven by a differentiated strategy focused on structural heart solutions [4][5] - Total sales for Q4 reached $1.57 billion, with adjusted earnings per share (EPS) of $0.58, although this was lower than expected due to increased spending on patient access initiatives and a higher tax rate [18][19] - The adjusted gross profit margin for Q4 was 78.3%, slightly down from 79.0% year-over-year, attributed to higher manufacturing expenses related to new therapies [19][20] Business Line Data and Key Metrics Changes - TAVR global sales in Q4 were $1.16 billion, increasing by 10.6% year-over-year, reflecting strong procedural growth and stable pricing [8][9] - TMTT sales grew over 40% to $156 million in Q4, with full year sales exceeding $1 billion, driven by the adoption of PASCAL and EVOQUE therapies [13][14] - Surgical product group sales for Q4 were $254 million, a 2% increase year-over-year, with full year sales surpassing $1 billion [15][16] Market Data and Key Metrics Changes - The U.S. market saw a significant increase in TAVR procedures, driven by a shift towards proactive disease management and the introduction of new clinical guidelines [10][11] - In Europe, TAVR procedure growth was healthy, supported by updated guidelines that emphasize proactive management of severe aortic stenosis [11][12] - The company noted modest year-over-year share improvement in several key countries, strengthening its leadership position following a competitor's exit [12] Company Strategy and Development Direction - The company is focused on pioneering new therapies and expanding indications to address unmet patient needs, with a long-term sales growth expectation of 10% annually [7][8] - The strategy emphasizes the importance of generating world-class clinical evidence to differentiate its valve technologies and maintain clinician preference [7] - The company plans to invest in the development of safe and effective valve therapies, with a commitment to addressing structural heart diseases [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting 2026 sales growth guidance of 8%-10% and EPS guidance of $2.90-$3.05, citing strong momentum entering the new year [23][25] - The management highlighted the importance of the Early TAVR trial and long-term data in reinforcing confidence among physicians and patients [5][10] - The company anticipates a potential tailwind from an updated national coverage determination for TAVR later in the year, which could enhance patient access [10][46] Other Important Information - The company has approximately $3 billion in cash and cash equivalents and $2 billion remaining under its share repurchase authorization [22][66] - Increased SG&A spending in Q4 was intentional to support strategic investments in patient access and education initiatives [20][36] Q&A Session Summary Question: Insights on TAVR growth and market share - Management noted that TAVR growth of 10.6% was supported by compelling clinical evidence and a renewed focus on proactive treatment, with share gains attributed to the exit of a competitor [28][30][31] Question: Increased spending on market access - The increase in SG&A spending was planned to support strategic initiatives, with expectations for moderated growth in 2026 [34][36] Question: TAVR NCD and its impact - Management indicated that the reopening of the NCD process is crucial for improving patient access, with potential impacts expected more significantly in 2027 and beyond [46][47] Question: LAA market opportunity - The company sees significant unmet needs in the LAA market and plans to enter this space with differentiated technology [49][51] Question: M3 uptake and European guidelines - The SAPIEN M3 launch is progressing as expected, with positive outcomes reported, while European guidelines are shifting towards proactive management of mitral and tricuspid diseases [70][73]

Financial Data and Key Metrics Changes - The company reported total sales of $1.57 billion for Q4 2025, reflecting an 11.6% year-over-year growth, and a full-year growth of 10.7% [4][19] - Adjusted earnings per share (EPS) for Q4 was $0.58, while GAAP EPS was $0.11, impacted by one-time charges related to the GeneValve acquisition and litigation expenses [19][20] - The adjusted gross profit margin for Q4 was 78.3%, slightly down from 79.0% in the previous year, attributed to increased manufacturing expenses [20][21] Business Line Data and Key Metrics Changes - TAVR global sales reached $1.16 billion in Q4, growing 10.6% year-over-year, with procedural growth in the high single digits [9][10] - TMTT sales grew over 40% to $156 million in Q4, with full-year sales exceeding $1 billion [15] - Surgical product group sales were $254 million in Q4, a 2% increase year-over-year, with full-year sales surpassing $1 billion [17] Market Data and Key Metrics Changes - The U.S. market showed strong procedural growth for TAVR, driven by increased urgency in treating severe aortic stenosis patients [11][52] - In Europe, updated guidelines are reshaping clinical discussions and expanding the patient population eligible for TAVR [12][50] - The company noted modest year-over-year share improvement in several key countries, strengthening its leadership position [13] Company Strategy and Development Direction - The company is focused on structural heart solutions, aiming for 8%-10% sales growth in 2026 and a long-term average annual sales growth of 10% [6][9] - Plans include pioneering new therapies, launching next-generation technologies, and expanding indications to treat more patients [8][9] - The company is investing in patient access initiatives and partnerships, such as with the American Heart Association, to improve care for heart valve disease [12][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting 2026 sales and EPS guidance, citing strong Q4 performance and growth catalysts [25][26] - The company anticipates a potential tailwind from an updated national coverage determination for TAVR later in the year [7][36] - Management highlighted the importance of lifetime management in TAVR, emphasizing the shift towards earlier treatment of aortic stenosis [41][42] Other Important Information - The company maintains a strong balance sheet with approximately $3 billion in cash and cash equivalents [23] - There is approximately $2 billion remaining under the share repurchase authorization, with plans to continue repurchasing shares opportunistically [24][47] Q&A Session Summary Question: Insights on TAVR growth and market share - Management noted strong TAVR growth of 10.6% year-over-year, driven by compelling clinical evidence and a renewed focus on TAVR as a treatment option [28] Question: Increased spending on market access initiatives - The company increased SG&A spending by $112 million year-over-year to support strategic investments in patient access and education [30] Question: Impact of distributor inventory adjustments - The company clarified that the distributor adjustments in Q4 were specific to one country and did not significantly impact overall sales [55]

Core Viewpoint - Edwards Lifesciences Corp. is expected to report strong fourth-quarter 2025 results, with revenue and earnings estimates indicating significant year-over-year growth [1][9]. Group 1: Earnings and Revenue Estimates - The Zacks Consensus Estimate for revenues is $1.54 billion, reflecting an 11.1% increase from the previous year [2]. - The earnings estimate is set at 62 cents per share, indicating a 5.1% rise from the year-ago figure [2]. - The company has consistently beaten earnings estimates in the past four quarters, with an average surprise of 8.89% [1]. Group 2: Segment Performance - The Transcatheter Aortic Valve Replacement (TAVR) segment is projected to generate $1.13 billion in sales, representing an 8.6% year-over-year increase, driven by strong performance and clinical community focus [6][9]. - The Transcatheter Mitral and Tricuspid Therapies (TMTT) segment is expected to see revenues of $151.6 million, implying a 44.2% improvement from the previous year, supported by the PASCAL, EVOQUE, and SAPIEN M3 systems [10][9]. - The Surgical Structural Heart segment is estimated to generate $259.8 million, suggesting a modest 6.3% rise from the year-ago quarter, aided by the global adoption of the RESILIA portfolio [12][11]. Group 3: Market Trends and Guidance - Edwards has raised its 2025 sales growth guidance for the TAVR segment to 7-8%, up from the previous 6-7% [6]. - The company is expected to benefit from global procedure growth and expanded education in the TAVR market, particularly in the U.S. [4][5]. - The recent FDA approval of the SAPIEN M3 mitral valve replacement system is anticipated to contribute positively to the company's top-line growth [8].

Summary of Edwards Lifesciences FY Conference Call (January 12, 2026) Company Overview - **Company**: Edwards Lifesciences (NYSE: EW) - **Industry**: Medical Technology (MedTech), specifically focusing on structural heart disease Core Points and Arguments 1. **Strategic Focus**: The company has concentrated on structural hearts over the past three years, deploying strategies across core platforms such as TAVR (Transcatheter Aortic Valve Replacement), TMTT (Transcatheter Mitral and Tricuspid Therapies), and surgical innovations, with a commitment to next-generation innovations [2][3][4] 2. **Market Opportunity**: There are over 20 million patients globally with unmet needs in structural heart disease, representing significant growth potential for the company [4] 3. **Innovation Commitment**: Edwards aims to pioneer therapies for patient groups currently without solutions, including those with asymptomatic aortic stenosis (AS), mitral disease, tricuspid disease, and aortic regurgitation [3][4] 4. **Product Development**: The company has launched two world-first catheter-based replacement valves for mitral and tricuspid conditions and continues to invest over $1 billion in R&D while achieving profitable growth [9] 5. **Financial Performance**: The company is on track to meet its sales guidance of 8-10% and exceed EPS guidance for 2025, with expectations for continued strong performance in 2026 [9][14] Growth Outlook 1. **Revenue Projections**: Edwards anticipates achieving $2 billion in revenue from TMTT by 2030, with overall sales growth projected at 8-10% and EPS growth of approximately 15% in 2026 [6][14] 2. **Market Dynamics**: The TAVR market is stabilizing and showing signs of acceleration, with a shift from a four-competitor to a three-competitor market, allowing Edwards to gain market share [18][20] 3. **Regulatory Developments**: The reopening of the U.S. National Coverage Determination (NCD) for TAVR is expected to improve patient access to this technology, potentially enhancing market volumes [11][24] Product and Technology Insights 1. **TAVR Innovations**: The SAPIEN platform is highlighted as the best-in-class technology, with recent studies proving its durability and effectiveness for asymptomatic patients [5][18] 2. **TMTT Portfolio**: The company has a comprehensive portfolio including PASCAL, EVOQUE, and SAPIEN M3, which are designed to provide personalized care [6][10] 3. **Emerging Therapies**: Edwards is developing new therapies for patients with limited options, such as TAVR for moderate AS and transcatheter therapies for heart failure [8][11] Financial Strategy and Capital Allocation 1. **Investment Focus**: The company prioritizes funding innovation and production capacity, with a commitment to maintaining high levels of R&D investment while improving operational efficiency [33][35] 2. **M&A Activity**: While M&A remains a priority, the company emphasizes internal innovation and early-stage investments over acquisitions [34][35] 3. **Share Repurchase**: Edwards plans to continue share repurchase programs to offset dilution and enhance shareholder value [34] Additional Insights 1. **Patient-Centric Approach**: The company emphasizes a patient-focused culture, with over 16,000 employees dedicated to improving patient care globally [4][5] 2. **Long-Term Vision**: Edwards aims to sustain double-digit growth and maintain its position as a pioneer in the MedTech industry, focusing on long-term innovation and market leadership [17][15] This summary encapsulates the key points discussed during the conference call, highlighting Edwards Lifesciences' strategic direction, market opportunities, product innovations, and financial outlook.

Summary of Edwards Lifesciences 2025 Investor Day Company Overview - **Company**: Edwards Lifesciences (NYSE: EW) - **Focus**: Structural heart disease, particularly in areas such as TAVR (Transcatheter Aortic Valve Replacement), mitral, and tricuspid valve therapies [1][3][12] Key Industry Insights - **Market Opportunity**: Structural heart disease represents a significant and growing market with millions of patients in need. The company aims to address large unmet patient needs through innovative therapies [4][16] - **Patient Burden**: Structural heart disease is the leading cause of hospitalization among middle-aged populations, creating a substantial burden on healthcare systems [19][22] Core Company Strategies - **Innovation Strategy**: Edwards focuses on breakthrough innovations to create and define new therapeutic categories, such as TAVR and tricuspid replacement [3][5] - **Long-term Commitment**: The company has a history of investing in innovation, with over $1 billion internally and $1.6 billion externally in structural heart disease [9][10] - **Diversified Growth Drivers**: The company has identified three primary growth drivers: TAVR, mitral, and tricuspid therapies, along with emerging opportunities in structural heart failure and aortic regurgitation [12][15] Financial Performance and Projections - **Sales Growth Guidance**: For 2025, the company expects total sales growth between 8% and 10%, with TAVR growth projected at 5% to 7% and TMTT (Transcatheter Mitral and Tricuspid Therapies) expected to grow by 50% to 60% [12][15] - **Earnings Per Share (EPS)**: Projected EPS for 2025 is between $2.40 and $2.50, setting a strong base for double-digit earnings growth in 2026 and beyond [12] Product Innovations and Pipeline - **TAVR Innovations**: The EARLY TAVR trial results indicate a shift in treatment paradigms, suggesting that patients with severe aortic stenosis should not wait for symptoms before treatment [30][45] - **Emerging Technologies**: The company is pursuing new technologies for aortic regurgitation, including the acquisition of J-Valve and JenaValve, which are expected to enhance treatment options [65] Clinical Insights - **Patient Management**: The company emphasizes the importance of timely intervention for patients with structural heart disease, advocating for a shift in clinical guidelines to treat patients based on disease severity rather than symptoms [57][63] - **Evidence Generation**: Edwards has a strong focus on generating clinical evidence to support its therapies, with over 10,000 patents and numerous FDA-approved studies [7][41] Challenges and Considerations - **Market Dynamics**: The company acknowledges challenges such as the slowing growth of TAVR and the need to expand treatment capacity in healthcare systems [38][39] - **Regulatory Changes**: Anticipated changes in guidelines and coverage determinations are expected to impact treatment pathways and patient access to therapies [62][63] Conclusion - **Long-term Vision**: Edwards Lifesciences is positioned for sustainable, long-term growth through its innovative product pipeline and commitment to addressing the needs of patients with structural heart disease [16][12]

Edwards Lifesciences 2025 Investor Conference 2025 Investor Conference Mark Wilterding Cautionary Statement Presentations and comments made today by management of Edwards Lifesciences Corporation (the "Company") will include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can sometimes be identified by the use of words, such as "may," "will," "should," ...

Core Insights - Edwards Lifesciences has announced its founding sponsorship of the American Heart Association's Heart Valve Initiative, aimed at improving care and outcomes for over 28 million people with heart valve disease globally, with more than 60,000 deaths annually in the U.S. attributed to valve disease [1][2]. Company Initiatives - The Heart Valve Initiative will focus on enhancing patient education, clinician training, and quality improvement to drive measurable impact in the treatment of heart valve disease [2][3]. - The initiative will expand the existing Target: Aortic Stenosis program, which was also founded through Edwards' sponsorship, over the next five years [3]. Goals and Objectives - The initiative aims to improve adherence to guideline-based care, starting with aortic stenosis, and will expand data collection to include asymptomatic and moderate cases [6]. - Plans include establishing a heart valve certification program for hospitals, advancing public reporting and hospital recognition, providing multimedia education for clinicians and patients, and launching a national awareness campaign to support informed care decisions [6].