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新式干式二尖瓣瓣膜在华上市
Xin Jing Bao· 2025-04-27 10:05
Group 1 - Edward Lifesciences announced the launch of the MITRIS RESILIA valve in China, which utilizes RESILIA technology for enhanced durability and offers a sustainable solution for patients requiring mitral valve replacement [1] - The MITRIS RESILIA valve is the first surgical bioprosthetic mitral valve to adopt the RESILIA fully enclosed anti-calcification technology, providing a new management solution for patients in China [1][2] - The valve has also received regulatory approval in the United States, Japan, and Canada, indicating its global market acceptance [1] Group 2 - The prevalence of cardiovascular diseases, particularly heart valve diseases, is increasing in China due to an aging population, making it the third most common cardiovascular condition after coronary heart disease and hypertension [2] - Surgical replacement remains the most widely used treatment for mitral valve diseases, with a trend towards less invasive, more durable, and personalized approaches [2] - The demand for minimally invasive surgical techniques is rising, as they reduce surgical trauma and improve patient outcomes [2] Group 3 - The MITRIS RESILIA valve features innovative RESILIA tissue processing technology that enhances valve durability by sealing the sources of calcification [3] - The valve's soft suture ring and low-profile design facilitate easier implantation, making it suitable for minimally invasive surgeries [3] - The valve's large opening design allows for future "valve-in-valve" interventions, ensuring a comprehensive solution for patients throughout their treatment journey [3]
Edwards Lifesciences Stock Earns Analyst Upgrade As Growth Outlook Brightens
Benzinga· 2025-04-24 18:42
Edwards Lifesciences‘ EW shares are trading higher Thursday after the company reported first-quarter 2025 sales of $1.41 billion.That’s almost in line with the consensus of $1.40 billion and the management guidance of $1.35 billion—$1.43 billion, up 6.2% year-over-year or 7.9% on an adjusted basis.Also Read: Trump Tariffs Spare Drugmakers But Threaten Diabetes Device IndustryIn the first quarter, the company reported: An adjusted EPS of 64 cents. It beat the consensus of 60 cents and remained within the man ...
EW Q1 Earnings & Revenues Beat, Stock Climbs, '25 Sales View Raised
ZACKS· 2025-04-24 11:45
Edwards Lifesciences Corporation (EW) reported first-quarter 2025 adjusted earnings per share (EPS) of 64 cents, which surpassed the Zacks Consensus Estimate by 6.7%. The figure increased 16.4% from the year-ago quarter’s level. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar).The quarter’s one-time adjustments primarily include certain litigation expenses and amortization of intangible assets.GAAP EPS from continuing operations was 62 cents compared with 54 cents in the first quarte ...
Edwards(EW) - 2025 Q1 - Earnings Call Transcript
2025-04-24 01:35
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 Lifesciences (EW) Q1 Earnings: How Key Metrics Compare to Wall Street Estimates
ZACKS· 2025-04-23 23:00
Core Insights - Edwards Lifesciences reported revenue of $1.41 billion for the quarter ended March 2025, reflecting an 11.6% decline year-over-year, with EPS at $0.64 compared to $0.66 in the previous year [1] - The revenue exceeded the Zacks Consensus Estimate of $1.4 billion by 0.71%, while the EPS surpassed the consensus estimate of $0.60 by 6.67% [1] Revenue Performance - Net Sales in Europe were $341.80 million, below the average estimate of $357.01 million, marking a 7.1% decrease year-over-year [4] - Net Sales outside the United States reached $573.80 million, slightly above the estimated $573.77 million, but down 12.7% from the previous year [4] - Net Sales in the United States totaled $838.90 million, below the average estimate of $849.03 million, representing a 10.8% decline year-over-year [4] - Net Sales in Japan were $81.80 million, significantly lower than the estimated $96.40 million, indicating a 26.2% decrease [4] - Net Sales in the Rest of the World amounted to $150.20 million, exceeding the estimate of $120.36 million, but down 16% year-over-year [4] Product Group Performance - Transcatheter Aortic Valve Replacement generated $1.05 billion, surpassing the average estimate of $1.03 billion, with a year-over-year increase of 3.8% [4] - Surgical Structural Heart sales were $250.90 million, slightly below the estimated $254.51 million, reflecting a 5.7% decline year-over-year [4] - Transcatheter Mitral and Tricuspid Therapies achieved $115.20 million, exceeding the average estimate of $113.82 million, with a substantial year-over-year increase of 58% [4] Stock Performance - Shares of Edwards Lifesciences have returned -0.9% over the past month, compared to a -6.6% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]
Edwards(EW) - 2025 Q1 - Quarterly Results
2025-04-23 20:33
[Q1 2025 Financial & Operational Overview](index=1&type=section&id=EDWARDS%20LIFESCIENCES%20REPORTS%20FIRST%20QUARTER%20RESULTS) Edwards Lifesciences reported strong Q1 2025 results, driven by its structural heart strategy, leading to increased sales guidance and key product approvals [Recent Highlights & CEO Statement](index=1&type=section&id=Recent%20Highlights) Edwards Lifesciences reported strong Q1 2025 results with significant sales growth and adjusted EPS, driven by its structural heart strategy and key product approvals Q1 2025 Key Performance Indicators | Metric | Value | Growth (YoY) | Growth (Constant Currency) | | :--- | :--- | :--- | :--- | | Total Sales | $1.41 billion | 6.2% | 7.9% (Adjusted) | | TAVR Sales | - | 3.8% | 5.4% | | TMTT Sales | $115 million | 58% | - | | EPS | $0.62 | - | - | | Adjusted EPS | $0.64 | - | - | - CEO Bernard Zovighian attributed the strong start to the year to the company's structural heart-focused strategy and unwavering dedication to innovation, expressing confidence in the 2025 outlook[3](index=3&type=chunk) - Key operational achievements include SAPIEN M3 CE Mark approval, a finalized National Coverage Determination (NCD) for EVOQUE to expand patient access, and positive data confirming the long-term durability of RESILIA tissue[4](index=4&type=chunk) - The company raised its full-year TMTT sales guidance to **$530-$550 million** and total sales guidance to **$5.7-$6.1 billion**, while reaffirming its adjusted EPS outlook of **$2.40-$2.50**[4](index=4&type=chunk) [Business Segment Performance](index=2&type=section&id=Business%20Segment%20Performance) The company's business segments, including TAVR, TMTT, and Surgical, demonstrated varied growth, driven by product innovation and market expansion [Transcatheter Aortic Valve Replacement (TAVR)](index=2&type=section&id=Transcatheter%20Aortic%20Valve%20Replacement%20(TAVR)) The TAVR segment achieved **$1.05 billion** in sales, driven by the SAPIEN 3 Ultra RESILIA platform and therapy adoption, with anticipated asymptomatic indication approval TAVR Q1 2025 Sales Performance | Metric | Value (USD) | Growth (YoY) | Growth (Constant Currency) | | :--- | :--- | :--- | :--- | | Q1 Sales | $1.05 billion | 3.8% | 5.4% | - In the U.S., the SAPIEN 3 Ultra RESILIA platform continues to perform strongly. Edwards is focused on helping hospitals manage increasing procedure volumes and expects asymptomatic indication approval in Q2[6](index=6&type=chunk) - Outside the U.S., growth was supported by the expansion of SAPIEN 3 Ultra RESILIA in Europe and efforts to address the undertreatment of aortic stenosis in Japan[7](index=7&type=chunk) [Transcatheter Mitral and Tricuspid Therapies (TMTT)](index=2&type=section&id=Transcatheter%20Mitral%20and%20Tricuspid%20Therapies%20(TMTT)) The TMTT segment experienced exceptional growth, with sales rising **58%** to **$115 million**, driven by global adoption of PASCAL and EVOQUE, and CE Mark approval for SAPIEN M3 TMTT Q1 2025 Sales Performance | Metric | Value (USD) | Growth (YoY) | Growth (Constant Currency) | | :--- | :--- | :--- | :--- | | Q1 Sales | $115 million | 58% | >60% | - Growth was led by increased adoption and balanced contribution from the PASCAL and EVOQUE systems in the U.S., Europe, and globally[8](index=8&type=chunk) - The portfolio was enhanced by the CE Mark approval of SAPIEN M3 in Europe, the world's first transcatheter mitral valve replacement system, which will benefit patients with limited treatment options[9](index=9&type=chunk)[10](index=10&type=chunk) [Surgical](index=2&type=section&id=Surgical) The Surgical segment reported global sales of **$251 million**, driven by positive procedure growth for the RESILIA tissue portfolio and key product launches Surgical Q1 2025 Sales Performance | Metric | Value (USD) | Growth (YoY) | Growth (Constant Currency) | | :--- | :--- | :--- | :--- | | Q1 Sales | $251 million | 1% | 3% | - Global procedure growth for the premium RESILIA tissue portfolio, including MITRIS, INSPIRIS, and KONECT, remains positive[11](index=11&type=chunk) - Key innovation milestones include the successful launch of MITRIS in China and the expected CE Mark approval for the KONECT aortic valved conduit in Europe before year-end[12](index=12&type=chunk) [Detailed Financials & Outlook](index=3&type=section&id=Detailed%20Financials%20%26%20Outlook) This section details Q1 2025 financial results, including improved gross profit margins and operating expenses, alongside updated 2025 guidance and comprehensive financial statements [Additional Financial Results (Q1 2025)](index=3&type=section&id=Additional%20Financial%20Results) Q1 2025 saw improved gross profit margin to **78.7%** and an adjusted operating margin of **29.1%**, with **$3.1 billion** in cash and cash equivalents Q1 2025 Financial Metrics | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Gross Profit Margin | 78.7% | 78.4% | | SG&A (% of sales) | 33.0% | - | | R&D (% of sales) | 18.0% | - | | Operating Profit Margin | 27.9% | - | | Adjusted Operating Margin | 29.1% | - | - SG&A expenses were lower than expected due to the deferral of certain strategic investments originally planned for Q1[13](index=13&type=chunk) - The company ended the quarter with approximately **$3.1 billion** in cash and cash equivalents and **$600 million** in total debt[15](index=15&type=chunk) [2025 Outlook](index=3&type=section&id=Outlook) Edwards Lifesciences raised its full-year 2025 TMTT sales guidance to **$530-$550 million** and total sales to **$5.7-$6.1 billion**, while reaffirming adjusted EPS guidance Updated Full-Year 2025 Guidance | Metric | New Guidance | Previous Guidance | | :--- | :--- | :--- | | Total Company Sales | $5.7 - $6.1 billion | Increased by $100M | | TMTT Sales | $530 - $550 million | $500 - $530 million | | Adjusted EPS | $2.40 - $2.50 | Reaffirmed | Q2 2025 Guidance | Metric | Guidance | | :--- | :--- | | Total Sales | $1.45 - $1.53 billion | | Adjusted EPS | $0.59 - $0.65 | - The company is implementing plans to mitigate anticipated cost pressures from a weakening dollar, tariffs, and the expected close of the JenaValve acquisition to maintain its full-year operating margin guidance of **27% to 28%**[16](index=16&type=chunk) [Financial Statements and Reconciliations](index=5&type=section&id=Financial%20Statements%20and%20Reconciliations) This section presents detailed unaudited financial statements for Q1 2025, including Consolidated Statements of Operations and reconciliations of GAAP to non-GAAP sales measures Unaudited Consolidated Statements of Operations (in millions) | Account | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net sales | $1,412.7 | $1,329.9 | | Gross profit | $1,111.1 | $1,043.0 | | Operating income, net | $394.8 | $349.0 | | Net income | $356.4 | $351.0 | | Diluted EPS | $0.61 | $0.58 | Reconciliation of Sales by Product Group (Constant Currency Growth) | Product Group | GAAP Growth | Constant Currency Growth | | :--- | :--- | :--- | | TAVR | 3.8% | 5.4% | | TMTT | 58.1% | 61.4% | | Surgical Structural Heart | 0.7% | 2.6% | | **Total** | **6.2%** | **7.9%** | Reconciliation of Sales by Region (Constant Currency Growth) | Region | GAAP Growth | Constant Currency Growth | | :--- | :--- | :--- | | United States | 7.3% | 7.2% | | Europe | 4.9% | 8.8% | | Japan | (4.9)% | (1.0)% | | Rest of World | 10.6% | 15.9% |
礼来首个小分子口服GLP-1药物3期临床研究成功,有望改变减重药物格局
Ping An Securities· 2025-04-20 13:13
Investment Rating - The industry investment rating is "Outperform the Market" [1][50]. Core Insights - Eli Lilly's first oral small molecule GLP-1 drug, Orforglipron, has successfully completed Phase 3 clinical trials, which is expected to change the landscape of weight loss medications [3][4]. - The ACHIEVE-1 trial showed that Orforglipron significantly reduced HbA1c levels by 1.3% to 1.6% from a baseline of 8.0% after 40 weeks, with over 65% of patients achieving HbA1c levels ≤6.5% [3][4]. - Patients receiving the highest dose of Orforglipron lost an average of 7.3 kg, indicating potential for further weight loss [4]. - Eli Lilly plans to submit a global application for Orforglipron for weight management by the end of this year and for type 2 diabetes treatment in 2026 [4][5]. Summary by Sections Industry Overview - The successful Phase 3 trial of Orforglipron positions it as a potential second oral GLP-1 drug in the U.S., following Novo Nordisk's Rybelsus [5]. Investment Strategy - Focus on "innovation," "overseas expansion," "equipment upgrades," and "consumer recovery" as key investment themes [7]. - Recommended companies include innovative drug developers and those with strong overseas market potential [7]. Key Companies to Watch - **Nocera Health**: Expected to achieve over 1 billion yuan in revenue from its core product, with a projected 49% year-on-year growth [8]. - **Sihuan Pharmaceutical**: Strong fundamentals with a stable growth outlook, particularly in the ADC market [11]. - **China Biopharmaceutical**: Rapid revenue growth with a focus on innovative products [13]. - **Aier Eye Hospital**: Benefiting from increasing demand in ophthalmology and ongoing overseas expansion [22]. Market Performance - The pharmaceutical sector saw a decline of 0.36% last week, while the broader market index rose by 0.59% [25][36].
Unlocking Q1 Potential of Edwards Lifesciences (EW): Exploring Wall Street Estimates for Key Metrics
ZACKS· 2025-04-18 14:20
Core Viewpoint - Analysts expect Edwards Lifesciences to report quarterly earnings of $0.60 per share, reflecting a year-over-year decline of 9.1%, with revenues projected at $1.4 billion, down 12.2% from the previous year [1] Earnings Estimates - Changes in earnings estimates are crucial for predicting investor reactions to stock performance, with empirical studies showing a strong correlation between earnings estimate revisions and short-term price performance [2] Key Metrics Overview - Analysts predict 'Net Sales by Product Group- Transcatheter Mitral and Tricuspid Therapies' will reach $113.82 million, indicating a year-over-year increase of 56.1% [4] - 'Net Sales by Product Group- Surgical Structural Heart' is forecasted to be $254.51 million, reflecting a decrease of 4.4% from the year-ago quarter [4] - 'Net Sales by Product Group- Transcatheter Aortic Valve Replacement' is expected to reach $1.03 billion, showing a year-over-year increase of 2.2% [5] - 'Net Sales- Europe' is projected at $357.01 million, indicating a decline of 2.9% from the prior-year quarter [5] - 'Net Sales- Outside of the United States' is estimated at $573.77 million, reflecting a year-over-year decrease of 12.7% [6] - 'Net Sales- United States' is expected to be $849.03 million, down 9.8% from the previous year [6] - 'Net Sales- Japan' is projected to reach $96.40 million, indicating a year-over-year decline of 13% [6] - 'Net Sales- Rest of World' is expected to be $120.36 million, reflecting a significant decrease of 32.7% from the year-ago quarter [7] Stock Performance - Edwards Lifesciences shares have increased by 0.8% over the past month, contrasting with the Zacks S&P 500 composite's decline of 6.9%, with a Zacks Rank of 3 (Hold) indicating expected performance in line with the overall market [7]
Solid TMTT Growth to Drive Edwards Lifesciences' Q1 Earnings
ZACKS· 2025-04-17 13:35
Edwards Lifesciences Corp. (EW) is scheduled to report first-quarter 2025 results on April 23, after market close.In the last reported quarter, the company’s adjusted earnings per share of 59 cents beat the Zacks Consensus Estimate by 7.27%. Its earnings beat estimates in two of the trailing four quarters and matched on the other two occasions, the average surprise being 2.60%. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)Q1 EstimatesThe Zacks Consensus Estimate for the company’s ...
最新!医械大厂CEO薪酬大揭秘
思宇MedTech· 2025-04-16 10:37
爱德华的 CEO Bernard Zovighian 这一薪酬包括 110 万美元的薪水和 610 万美元的股票奖励。 570 万 美元的期权奖励、 140 万美元的奖金和 98028 美元的其他薪酬,显示出公司对高层管理者的激励机制 高度依赖于绩效和长期股权奖励。 心血管医疗器械作为全球最大的细分市场之一,近年来发展迅速,预计到 2026 年,全球心血管医疗器械 市场规模将达到 822 亿美元 ,年均复合增长率为 6.9% 。这一市场的快速增长为爱德华等企业提供了巨 大的发展机遇。 Bernard Zovighian 于 2023 年 5 月正式担任爱德华的 CEO ,其薪酬结构体现了公司对创新和市场竞 争力的重视。与行业其他 CEO 相比,他的薪酬虽然低于强生的 Joaquin Duato ( 4930 万美元)和瑞 思迈的 Michael Farrell ( 4290 万美元),但仍处于行业较高水平。 报名:首届全球眼科大会 | 参会须知 报名:首届全球骨科大会 | 议程更新 报名:首届全球心血管大会 | 奖项申报 合作伙伴征集:2025全球手术机器人大会 心未来 近日, 爱德华生命科学 ( Edwar ...