Edwards Lifesciences FY Conference Summary Company Overview - **Company**: Edwards Lifesciences (NYSE: EW) - **Date of Conference**: March 10, 2026 - **Key Speakers**: Scott Ullem (CFO), Mark Wilterding (Head of Investor Relations), Sydney Bailey (Investor Relations Team) Core Industry Insights - **Sustainable Growth**: Edwards Lifesciences aims for double-digit sustainable growth, driven by established TAVR business and emerging TMTT (Transcatheter Mitral and Tricuspid Therapies) [3][4] - **TAVR Business**: TAVR remains a cornerstone of growth, expected to grow mid-single digits annually [7] - **TMTT Growth**: TMTT is projected to reach $2 billion in revenue by 2030, with expected growth rates of 35%-45% in 2026 [7][8] Financial Projections - **TMTT Revenue**: Expected to grow from over $500 million in 2025 to $740 million-$780 million in 2026 [8] - **Overall Growth Expectation**: Anticipated double-digit growth of approximately 10% annually, combining TAVR, TMTT, and surgical business performance [8] Product Development and Market Strategy - **Innovative Therapies**: Introduction of new therapies like PASCAL for mitral and tricuspid, and SAPIEN M3 for mitral valve replacement, providing options for patients historically limited to surgical interventions [10][11] - **Heart Failure Management**: Development of Cordella device for heart failure management, addressing a significant patient population with limited treatment options [16][17] - **Aortic Regurgitation**: Acquisition of technology for catheter-based replacement of diseased aortic valves, with a focus on addressing different disease states [21][22] Market Opportunities - **EARLY TAVR Trial**: Results from the trial indicate the need for valve replacement in severe aortic stenosis patients regardless of symptoms, leading to increased physician interest [25][26] - **CMS Evaluation**: Anticipation of a more accommodating National Coverage Determination (NCD) to facilitate patient referrals for valve replacement [26] Long-term Vision - **Comprehensive Care**: Emphasis on developing multi-device and multi-therapy solutions for patients at risk of heart failure, recognizing the interplay between different structural heart conditions [20][21] - **Strategic Investments**: Commitment to investing in technologies that align with core competencies, particularly in structural heart failure [21] Additional Considerations - **Patient Eligibility**: Importance of a toolkit approach to cater to diverse patient anatomies and treatment needs, ensuring tailored therapeutic interventions [13] - **Market Dynamics**: Recognition of differing opinions within the medical community regarding the timing of treatment for aortic stenosis patients [28]

Financial Data and Key Metrics Changes - The company reported total sales of $1,530 million for Q2 2025, reflecting a growth of 10.6% compared to the previous year, which was better than expected [9][10]. - Adjusted earnings per share (EPS) for the quarter was $0.67, while GAAP EPS was $0.57, which included a one-time charge related to external investments [26][27]. - The adjusted gross profit margin was 77.6%, down from 80% in the same period last year, attributed to increased manufacturing expenses and foreign exchange impacts [27][28]. Business Line Data and Key Metrics Changes - In the Transcatheter Aortic Valve Replacement (TAVR) segment, global sales reached $1,100 million, marking a 7.8% increase year-over-year [10][11]. - The Transcatheter Mitral and Tricuspid Therapies (TMTT) segment saw sales of $133 million, growing 57% due to strong demand for PASCAL and EVOQUE technologies [18][19]. - Surgical Products Group reported global sales of $267 million, an increase of 6.8% compared to the prior year [24]. Market Data and Key Metrics Changes - TAVR growth was stable in both the U.S. and outside the U.S. (OUS), with a notable increase in Japan where sales grew in the mid-single digits [15][10]. - The exit of a competitor in Europe led to a rebalancing of market share, contributing modestly to sales growth [15][44]. - The company anticipates mid to high single-digit growth opportunities in TAVR, supported by recent approvals and guideline changes [16][10]. Company Strategy and Development Direction - The company introduced the "Sharpen Focus" strategy, targeting significant growth in structural heart therapies, particularly in aortic regurgitation and heart failure [8][9]. - The focus on a balanced portfolio across aortic, mitral, and tricuspid therapies is expected to position the company for long-term leadership [9]. - The company is raising its full-year 2025 sales growth guidance to 9% to 10%, reflecting confidence in its strategic initiatives and market position [10][33]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve sustainable growth, driven by a strong portfolio and upcoming catalysts [34][66]. - The management highlighted the importance of recent approvals for asymptomatic TAVR, which are expected to create multi-year growth opportunities [11][12]. - The company is optimistic about the impact of potential changes in CMS guidelines and the NCD on patient access and treatment volumes [61][62]. Other Important Information - The company announced the departure of Larry Wood, the leader of the TAVR team, who will be succeeded by Dan Lippis [16][17]. - The company is in the final stages of the regulatory review process for the acquisition of GenaValve, with expectations to close the deal in Q3 [33]. Q&A Session Summary Question: What drove the better-than-expected U.S. TAVR performance? - Management attributed the performance to a renewed focus on TAVR within the clinical community and the impact of early TAVR study data [36][38]. Question: What trends were observed outside the U.S.? - Management noted positive feedback from the rollout of the S3UR platform in Europe and emphasized the importance of addressing undertreatment in Japan [43][45]. Question: Why not raise EPS guidance further? - Management cited ongoing headwinds, particularly related to GenaValve, as a reason for caution despite strong Q2 performance [48][49]. Question: What is the expected impact of the NCD reopening? - Management expressed optimism that changes could streamline operator requirements, improving patient access and care [61][62]. Question: What is the outlook for the TMTT business, particularly EVOQUE? - Management reported strong physician and patient excitement around EVOQUE, with real-world outcomes aligning with clinical trial data [71][72].