Core Viewpoint - Edwards Lifesciences has eliminated its anti-copycat policy, leading to the closure of an EU antitrust investigation against the company [1]. Group 1: Company Actions - Edwards Lifesciences has withdrawn its Global Unilateral Pro-Innovation (Anti-Copycatting) Policy (UPIP), which was previously a point of contention with Indian rival Meril [1]. - The European Commission confirmed that the removal of the UPIP from the company's website indicates that the concerns regarding market power abuse have been addressed [1]. Group 2: Regulatory Context - The European Commission had conducted an investigation into Edwards Lifesciences after a complaint from Meril, which alleged that the company was abusing its market position [1]. - The Commission's investigation included a raid on one of Edwards Lifesciences' facilities in September 2023 [1]. - The closure of the investigation means that further action is not considered a priority at the EU level [1].

Edwards Lifesciences Corporation (NYSE:EW) is one of the best medical technology stocks to invest in. On February 11, Stifel reiterated its Buy rating on Edwards Lifesciences and kept its price target at $110. Stifel made the move right after Edwards Lifesciences shared its Q4 2025 earnings on February 10. The results showed that quarterly sales went up by 11.6% to $1.57 billion and beat Stifel and consensus estimates of $1.54 billion and $1.55 billion, respectively. Edwards Lifesciences Corporation (EW) ...

IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences Corporation (NYSE: EW) today announced it will participate in Citi's Unplugged Medtech and Life Sciences Access Day on February 26, 2026. Scott Ullem, chief financial officer, is scheduled to present at 10:15 a.m. ET. A live webcast of the presentation will be available on the Edwards Lifesciences investor relations website at http://ir.edwards.com/, with an archived version accessible later the same day. About Edwards Lifesciences Edwards L. ...

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]

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Edwards Lifesciences (NYSE:EW) Q4 2025 Earnings call February 10, 2026 05:00 PM ET Company ParticipantsBernard Zovighian - CEODan Lippis - Global Leader of TAVRDaveen Chopra - Global Head for TMTT, Surgical, and IHFMDavid Roman - Managing DirectorGerianne Sarte - Senior VP of Investor RelationsJoanne Wuensch - Managing DirectorMatt Taylor - Managing DirectorScott Ullem - CFOTravis Steed - Managing Director of Equity Research and Medical TechnologyVijay Kumar - Senior Managing DirectorConference Call Partici ...

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 has forecasted 2026 profit above estimates, driven by strong demand for its artificial heart valves and other medical devices, resulting in a 3% increase in shares during after-hours trading [1] Group 1 - The company anticipates robust demand for its artificial heart valves and medical devices [1] - The positive forecast has led to a rise in the company's stock price by 3% in after-hours trading [1]

Sales Performance - Q4 2025 sales increased by 13.3% to $1.57 billion, with constant currency sales growth of 11.6%[5] - Q4 TAVR sales rose by 12.0% to $1.16 billion, with constant currency sales growth of 10.6%[5] - Q4 TMTT sales grew over 40% to $156 million, driven by repair and replacement therapies[5] - FY 2025 sales grew by 11.5%, with constant currency growth of 10.7%[5] - For the three months ended December 31, 2025, Edwards Lifesciences reported net sales of $1,569.6 million, representing a 13.2% increase from $1,385.8 million in the same period of 2024[43] - Year-to-date sales for 2025 totaled $6,067.6 million, an 11.5% increase from $5,439.5 million in 2024[45] - The United States market contributed $3,543.1 million in sales for 2025, representing a 10.5% growth from $3,206.0 million in 2024[45] - Sales in Europe increased by 14.8%, reaching $1,517.5 million in 2025 compared to $1,321.7 million in 2024[45] - The Rest of World segment reported a 14.0% growth, with sales of $652.3 million in 2025, up from $572.0 million in 2024[45] - The Transcatheter Aortic Valve Replacement segment's year-to-date sales for 2025 were $4,487.7 million, a 9.3% increase from $4,106.1 million in 2024[45] Financial Metrics - Gross profit margin for Q4 was 78.1%, with an adjusted margin of 78.3%[16] - Operating profit margin for Q4 was 9.6%, with an adjusted margin of 23.7%[18] - Gross profit for the year ended December 31, 2025, was $4,733.4 million, up from $4,322.0 million in 2024, reflecting a gross margin of 78.0%[28] - The adjusted operating income margin for the twelve months ended December 31, 2025, was 27.1%, compared to 25.3% in 2024[44] - The effective tax rate for the year was 17.0%, compared to 9.8% in 2024[28] - The effective tax rate for the twelve months ended December 31, 2025, was 17.0%, an increase from 9.8% in the previous year[44] Income and Expenses - Operating income for Q4 2025 was $151.1 million, down from $312.6 million in Q4 2024, with an operating margin of 9.6%[28] - Net income from continuing operations for the year was $1,056.0 million, a decrease from $1,396.0 million in 2024[28] - Basic earnings per share for the year was $1.84, down from $6.98 in 2024[28] - Selling, general and administrative expenses in Q4 were $603 million, representing 38.4% of sales[17] - Research and development expenses for the year totaled $1,079.2 million, compared to $1,053.0 million in 2024, representing 17.8% of net sales[28] - The company incurred litigation expenses of $208.6 million in Q4 2025, significantly higher than $12.6 million in Q4 2024[33] - The company incurred certain litigation expenses totaling $325.4 million for the twelve months ended December 31, 2025, impacting the net income[44] Impairment and Adjustments - The company recorded a loss on impairment of $99.8 million in Q4 2025 related to its investment in JenaValve Technologies[37] - Edwards Lifesciences reported a loss on impairment charges of $112.5 million for the twelve months ended December 31, 2025[44] - Non-GAAP adjustments for the twelve months ended December 31, 2025, included $1,643.5 million in adjusted operating income, reflecting the company's strategic financial management[44] Future Outlook - FY 2026 revenue outlook anticipates TMTT growth of 35% to 45%, reaching $740 million to $780 million[5] - Increased confidence in FY 2026 adjusted EPS guidance of $2.90 to $3.05[5] - The company plans to provide guidance for sales and growth rates on a "constant currency basis" to enhance comparability with historical results[32] - The company plans to continue focusing on market expansion and new product development to drive future growth[43]