Financial Data and Key Metrics Changes - Total company sales grew 8% to $1.041 billion in Q1 2025, driven by a broad portfolio of therapies for structural heart disease [9][10] - Adjusted EPS for the quarter was $0.64, with GAAP EPS at $0.62 [38] - Adjusted gross profit margin was 78.7%, slightly up from 78.5% in the previous year [39] - Full-year total company sales growth guidance is maintained at 8% to 10%, with total sales expected to be between $5.7 billion and $6.1 billion [16][37] Business Line Data and Key Metrics Changes - TAVR sales reached $1.05 billion, a 5.4% increase year-over-year, with growth comparable in both the US and OUS [18][25] - TMTT sales were $150 million, representing a 60% growth, driven by increased adoption of Pascal and Evoque [26] - Surgical product group sales were $251 million, a 3% increase from the prior year [33] Market Data and Key Metrics Changes - TAVR growth was supported by the expansion of SAPIEN 3 Ultra Resilia in Europe, while Japan faced weaker procedure growth and competitive pressure [24][25][111] - The NCD for Evoque is expected to enhance patient access and treatment opportunities [57] Company Strategy and Development Direction - The company is focused on TAVR innovation and expanding access to treatment options for all AS patients, with upcoming indication approvals expected to drive growth [11][16] - The strategy includes a commitment to developing a transcatheter tricuspid valve and advancing surgical innovations [12][13] - The company aims to address the significant undertreatment of AS in Japan and enhance capabilities in the region [112] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to offset tariff impacts and the dilution from the Yenovale acquisition [16][37] - The company anticipates a multiyear growth opportunity from TAVR and TMTT innovations, with a strong focus on patient care and physician support [11][16][100] Other Important Information - The company has approximately $3 billion in cash and cash equivalents, with ongoing share repurchase programs [43] - The company is committed to maintaining a strong balance sheet while investing in strategic growth areas [43] Q&A Session Summary Question: EPS guidance maintenance despite tariffs and acquisition impacts - Management clarified that the EPS guidance accounts for tariff impacts of about $0.05 and Yenovale acquisition impacts of $0.05 to $0.10 [51][53] Question: Impact of NCD on Evoque ramp-up - Management indicated that the NCD ensures access for Medicare beneficiaries and aligns with expectations for 2025 growth [57] Question: TAVR business trends and referral patterns - Management noted that physicians are taking time to understand new data, with plans to support market development post-indication approval expected in Q2 [67][68] Question: Capacity constraints and NCD implications - Management discussed the need for NCD updates to cover asymptomatic patients and expand treatment centers [83][84] Question: Trends in Japan's market - Management acknowledged weaker growth in Japan but remains optimistic about long-term opportunities due to an aging population [111][113]
Edwards(EW) - 2025 Q1 - Earnings Call Transcript