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- **12.6% Q3 Revenue Growth**: Driven by TAVR (10.6%), TMTT (53%), and surgical RESILIA adoption.
- **Guidance Raise**: Full-year sales 9-10%, EPS $2.56-$2.62, TAVR 7-8% growth.
- **SAPIEN Durability**: 7-year PARTNER III data shows 1.3% mortality, supporting earlier TAVR adoption.
- **TMTT Expansion**: EVOQUE tricuspid replacement grows 53%, M3 U.S. approval Q1 2026.
- **CFO Transition**: Scott Ullem to step down mid-2026 with successor search underway.

**【CEO Summary Section】**
- Q3 2025 revenue grew 12.6% to $1.55 billion, driven by TAVR, TMTT, and surgical products.
- Raised full-year sales guidance to 9-10% growth and EPS to $2.56-$2.62, citing TAVR adoption and guideline updates.
- TAVR sales up 10.6%, supported by 7-year PARTNER III data showing SAPIEN durability; TMTT grew 53% on EVOQUE and PASCAL.
- Surgical RESILIA portfolio expanded in Europe, with 7-year PARTNER III data validating surgical valve performance.

**【CFO Financial Commentary】
- Adjusted EPS $0.67 (vs. $0.58 est.), driven by $1.55B sales and $515M SG&A deferral.
- Gross margin 77.9%, stable vs. prior year; R&D spend $281M (+11%) focused on TMTT pipeline.
- Full-year operating margin 27-28%, with Q4 margin ~25% due to $100M+ investments.
- FX to add $30M to 2025 sales; TAVR guidance raised to 7-8% growth.
- CFO Scott Ullem to transition by mid-2026, with smooth succession planned.

**【Q&A Key Highlights】
- TAVR Q3 growth 10.6% from U.S. procedure growth and Europe competitor exit; TMTT up 53% on EVOQUE real-world data.
- SAPIEN X4 pivotal data pending; JenaValve regulatory update expected Q1 2026.
- TMTT 2030 target $2B; M3 U.S. approval early 2026 with controlled launch strategy.
- Surgical valve procedures up 5.6% on RESILIA adoption; TAVR 7-year data supports asymptomatic treatment.
- R&D spend prioritized for TMTT; FX to add $30M 2025 sales upside.

Edwards Lifesciences Corporation (EW) Q3 2025 Earnings Call Transcript

- **Q2 Growth Surpasses Expectations**: 10.6% sales growth ($1.53B) driven by TAVR (7.8%), TMTT (57%), and Surgical (6.8%).
- **Strategic Catalysts**: Asymptomatic AS approvals, SAPIEN M3 CE Mark, and JenaValve acquisition support 9-10% 2025 sales guidance.
- **Margin Focus**: 2026+ target: 50-100bps annual margin expansion, despite near-term JenaValve headwinds.
- **TMTT Breakthrough**: PASCAL and EVOQUE real-world outcomes match clinical trials; SAPIEN M3 U.S. approval expected H1 2026.
- **Leadership Transition**: Dan Lippis to lead TAVR globally, ensuring continuity amid Larry Wood's departure.

**【CEO Summary Section】**
- **Double-Digit Sales Growth**: Q2 2025 total sales of $1.53 billion grew 10.6% YoY, driven by TAVR, TMTT, and Surgical product groups.
- **TAVR Momentum**: Global TAVR sales of $1.1 billion (+7.8% YoY), with U.S. and OUS growth balanced. Asymptomatic AS approvals and clinical data (e.g., 10-year PARTNER II outcomes) are key growth drivers.
- **TMTT Expansion**: TMTT sales of $133 million (+57% YoY), with PASCAL and EVOQUE leading growth. SAPIEN M3 CE Mark received, targeting U.S. approval in H1 2026.
- **Surgical Resilience**: Surgical sales of $267 million (+6.8% YoY), supported by INSPIRIS and KONECT adoption.
- **Leadership Transition**: Larry Wood departing in September; Dan Lippis to lead TAVR globally.

**【CFO Financial Commentary】**
- **Q2 Financials**: GAAP EPS $0.57 (incl. one-time charge), adjusted EPS $0.67. Gross margin 77.6% (vs. 80% YoY), impacted by manufacturing costs and FX.
- **Guidance Update**: Full year sales growth raised to 9-10% ($5.9-6.1B), adjusted EPS at high end of $2.40-2.50 range.
- **Expense Trends**: SG&A $502M (+12% YoY), R&D $276M (+1.5% YoY). Operating margin 28.2% (vs. 27.5% YoY), with H2 margin pressure from JenaValve acquisition.
- **FX Impact**: FX adds ~$30M to 2025 sales, but weakens gross margin by 60bps YoY.

**【Q&A Key Highlights】**
- **U.S. TAVR Growth**: Renewed focus on asymptomatic AS and early TAVR data drove Q2 momentum. Centers prioritizing timely referrals and streamlined workflows.
- **International Trends**: Europe benefiting from competitor exit; Japan TAVR growth improving. Rest of World (ROW) TAVR up mid-single digits.
- **EPS Leverage**: 2026+ target: 50-100bps annual margin expansion. JenaValve acquisition expected to close Q3, with EPS impact in H2.
- **NCD & Operator Changes**: CMS NCD update expected to streamline TAVR access, potentially allowing single-operator procedures. Long-term catalyst for capacity expansion.
- **TMTT Pipeline**: SAPIEN M3 pivotal data at TCT 2025; EVOQUE late-breaking ESC 2025 substudy. Gen 2+ innovations planned for 2026+.

Edwards Lifesciences Corporation (EW) Q2 2025 Earnings Call Transcript

- **Q1 Strong Start**: $1.41B revenue (+8% YoY), driven by TAVR (+5.4%) and TMTT (+60%).
- **TMTT Guidance Raised**: $530M-$550M (prev $480M-$520M) due to FX and momentum.
- **Key Milestones**: EARLY TAVR Q2 approval, SAPIEN M3 Europe launch, EVOQUE NCD finalized.
- **EPS Resilience**: Maintained $2.40-$2.50 guidance despite $0.10-$0.15 headwinds from tariffs/JenaValve.
- **Growth Drivers**: TAVR asymptomatic expansion, M3 mitral replacement, and EVOQUE tricuspid replacement.

**【CEO Summary Section】**
- Q1 2025 total revenue reached $1.41 billion, up 8% YoY, driven by TAVR ($1.05B, +5.4%) and TMTT ($115M, +60%).
- Raised TMTT sales guidance to $530M-$550M (prev $480M-$520M) due to FX and momentum.
- EARLY TAVR indication expected Q2 approval, targeting asymptomatic AS patients.
- SAPIEN M3 mitral valve replacement approved in Europe, with U.S. launch in 2026.
- Surgical sales $251M (+3%), supported by RESILIA portfolio and 8-year durability data.
- Full year 2025 total company sales growth guidance maintained at 8%-10%.

**【CFO Financial Commentary】**
- Q1 2025 adjusted EPS: $0.64 vs. $0.62 GAAP EPS.
- Gross margin: 78.7% (flat YoY), operating margin: 29.1% (vs. 28.5% YoY).
- Tariffs and JenaValve acquisition expected to impact EPS by $0.05-$0.10, offset by cost control.
- 2025 EPS guidance maintained at $2.40-$2.50, despite $100M FX headwind.
- $300M share buyback in Q1, $1B remaining under repurchase authorization.

**【Q&A Highlights】**
- **TAVR Expansion**: EARLY TAVR indication approval in Q2, with potential multiyear growth. NCD update expected to expand access.
- **TMTT Momentum**: EVOQUE NCD finalized, treating tricuspid patients ineligible for surgery/TEER. SAPIEN M3 launch in Europe focused on high-touch training.
- **Japan Challenges**: Weaker procedure growth and competition, but long-term opportunity due to aging population.
- **JenaValve Impact**: $0.05-$0.10 EPS dilution, offset by operational efficiency.
- **Surgical Outlook**: MITRIS launch in China, KONECT CE Mark in Europe, supporting mid-single-digit growth.


Edwards Lifesciences (EW)-23 Apr 25-2025 Q1 Earnings call transcript

- **2024 Performance**: Total sales $5.4 billion (+9%), TMTT outperformed (+77%), Surgical (+6%).
- **2025 Guidance**: $5.6–$6.0 billion (8%–10% growth). TMTT targeting $500–$530 million, TAVR 5%–7%.
- **Key Catalysts**: Asymptomatic TAVR approval (mid-2025), EVOQUE CMS coverage, SAPIEN M3 launch.
- **Financial Highlights**: Q4 EPS $0.59, 2025 operating margin 27%–28%, FX headwinds $130 million.
- **Growth Drivers**: Japan TAVR expansion, U.S. TMTT adoption, Europe market penetration.


**【CEO Opening Remarks】**
- Full year 2024 total sales reached $5.4 billion, up 9% YoY, in line with original guidance. TAVR grew 6%, TMTT exceeded expectations with 77% YoY growth, and Surgical grew 6%.
- 2025 outlook: Total company sales guidance of $5.6–$6.0 billion (8%–10% growth). TAVR expected to grow 5%–7%, TMTT targeting $500–$530 million, and Surgical $970–$1.05 billion.
- Strategic focus on TAVR expansion (asymptomatic approval in mid-2025) and TMTT portfolio (PASCAL repair, EVOQUE replacement, SAPIEN M3 mitral).
- Japan identified as key growth opportunity for TAVR, despite slower Q4 growth.

**【CFO Financial Review】**
- Q4 2024 total sales: $1.39 billion (9% YoY growth). Adjusted EPS: $0.59, above expectations. GAAP EPS: $0.58.
- Gross margin: 79% (flat YoY). SG&A: $492 million (35.5% of sales), up due to TMTT field expansion and post-Critical Care transition.
- R&D: $271 million (19.6% of sales), driven by acquisitions. Operating margin: 25.6%, guiding to 27%–28% for 2025.
- 2025 tax rate expected 15%–18%. FX headwinds projected to reduce sales by ~$130 million (2.5% YoY drag).
- Q1 2025 guidance: Sales $1.35–$1.43 billion, adjusted EPS $0.58–$0.64.

**【Q&A Key Themes】**
- **TMTT Growth**: PASCAL adoption strong in U.S. and Europe; EVOQUE launch progressing in U.S. and Europe. 2025 TMTT sales target $500–$530 million. CMS NCD for EVOQUE expected Q1 2025.
- **TAVR Dynamics**: Q4 U.S. growth 5.3%, Japan lagging. Asymptomatic TAVR approval in mid-2025 seen as multiyear growth catalyst. Capacity constraints temporary, improving in 2025.
- **Financial Management**: SG&A to remain flat in 2025; R&D as % of sales to moderate. Free cash flow healthy with $3 billion balance sheet.
- **Competitive Landscape**: Edwards maintains TAVR leadership with SAPIEN 3 Ultra RESILIA. Differentiated clinical evidence and technology positioning.
- **M3 Mitral Replacement**: CE Mark expected mid-2025, U.S. approval 2026. Targeting patients unsuitable for TR repair.


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