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]

Core Viewpoint - The article discusses the regulatory challenges faced by Edwards Lifesciences in its acquisition of JenaValve Technology, highlighting the significance of the Trilogy system in the transcatheter aortic valve replacement (TAVR) market and the implications for the treatment of aortic regurgitation (AR) [2][10][14]. Group 1: Acquisition and Regulatory Challenges - On August 6, 2025, the FTC filed a lawsuit to block Edwards Lifesciences' acquisition of JenaValve Technology, citing concerns over reduced competition and potential negative impacts on innovation and patient choice [2][11]. - Edwards announced its intention to acquire JenaValve for $1.2 billion (approximately 8.6 billion RMB) in July 2024, aiming to enhance its TAVR product portfolio and address the long-standing treatment gap for AR [2][10]. - The FTC's action reflects a broader scrutiny from global regulatory bodies regarding market concentration in the structural heart disease sector, with the Austrian Federal Competition Authority also initiating a second-phase review of the transaction [12]. Group 2: Trilogy System and Market Implications - The Trilogy system, developed by JenaValve, represents a significant technological advancement in AR treatment, utilizing a self-expanding nitinol frame and a unique anchoring mechanism that does not rely on calcification [5][8]. - The system is designed to address the challenges faced by AR patients, particularly those with non-calcified annuli, and is expected to receive FDA approval by the end of 2025, potentially transforming the AR treatment landscape [8][13]. - Edwards aims to leverage its global sales network and clinical channels to accelerate the commercialization of Trilogy, which could provide a breakthrough treatment option for over 8 million severe AR patients in the U.S. alone [10][14]. Group 3: Financial Performance and Strategic Focus - Edwards Lifesciences has shown strong financial performance, with total revenue increasing by 11.9% year-over-year in Q2 2025, and TAVR sales growing by 8.9%, reflecting confidence in its core business despite regulatory uncertainties [13]. - The company is strategically focusing on expanding its structural heart portfolio, having sold its critical care business for $4.2 billion to BD, indicating a shift towards enhancing its capabilities in the structural heart market [10][13].