Tendyne transcatheter mitral valve replacement (TMVR) system

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Abbott Taps Growing TMVR Market With Tendyne System
ZACKS· 2025-08-14 13:36
Key Takeaways Abbott gains FDA approval for its Tendyne TMVR system targeting severe mitral annular calcification.Tendyne offers a minimally invasive alternative for high-risk patients unable to undergo open-heart surgery.ABT system's unique, repositionable design adapts to various anatomies for optimal patient outcomes.Abbott Laboratories (ABT) recently received Food and Drug Administration (“FDA”) approval for its Tendyne transcatheter mitral valve replacement (TMVR) system. The Tendyne system replaces mi ...
Abbott Stock Falls in Pre-Market Despite Q2 Earnings and Sales Beat
ZACKS· 2025-07-17 16:11
Core Insights - Abbott Laboratories (ABT) reported second-quarter 2025 adjusted earnings per share (EPS) of $1.26, beating the Zacks Consensus Estimate by 0.8% and improving 10.5% year over year [2][8] - Despite strong earnings and revenue results, ABT stock fell 5% in pre-market trading due to cautious third-quarter guidance [2][8] Revenue Performance - Worldwide sales reached $11.14 billion, a 7.4% increase year over year, surpassing the Zacks Consensus Estimate by 0.6% [3][8] - Organic sales improved by 6.9% year over year, with organic sales excluding COVID-19 rising by 7.5% [3] Segment Analysis - Established Pharmaceuticals segment sales increased by 6.9% on a reported basis to $1.38 billion, with organic sales in emerging markets growing by 8.7% [4] - Medical Devices segment sales rose 13.4% year over year to $5.37 billion, driven by Diabetes Care and Structural Heart products [5][8] - Diabetes Care division reported organic sales growth of 19.6%, with continuous glucose monitors contributing $1.90 billion to total sales [6] - Nutrition sales rose 2.9% year over year to $2.21 billion, with Adult Nutrition benefiting from strong global growth [7] - Diagnostics sales declined 1% year over year to $2.17 billion, impacted by lower COVID-19 testing-related sales [9] Margin and Expense Details - Gross profit increased by 8.9% year over year to $6.29 billion, with gross margin expanding by 79 basis points to 56.4% [9][10] - Selling, general and administration expenses rose 5.3% to $3.09 billion, while research and development expenses increased by 3.9% to $725 million [10] Financial Guidance - For full-year 2025, Abbott expects adjusted diluted EPS in the range of $5.10-$5.20, with organic sales growth projected at 7.5-8.0% [11] - Third-quarter adjusted diluted EPS is expected to be between $1.28 and $1.32, slightly below the Zacks Consensus Estimate of $1.34 [12] Strategic Developments - Abbott announced favorable data from the AVEIR Conduction System Pacing clinical study and received FDA approval for its Tendyne transcatheter mitral valve replacement system [14] - Plans to develop a new cardiovascular device manufacturing facility in Georgia, expected to be completed by 2028 [14]
ABT to Report Q2 Earnings: CGM and Cardiac Devices in Focus
ZACKS· 2025-07-14 13:31
Core Insights - Abbott Laboratories (ABT) is expected to report second-quarter 2025 results on July 17, with adjusted earnings per share (EPS) of $1.09 in the last quarter, surpassing the Zacks Consensus Estimate by 1.9% [1] - The Zacks Consensus Estimate for revenues is $11.07 billion, indicating a 6.7% increase year-over-year, while EPS is estimated to rise 9.6% to $1.25 [1][2] Revenue Estimates by Segment - **Diagnostics**: Expected revenue growth impacted by a decline in COVID-19 testing revenues, but anticipated to benefit from high demand across various settings. Estimated revenue increase of 0.1% year-over-year [3][4][6] - **Established Pharmaceuticals (EPD)**: Projected to continue strong performance across multiple regions and therapeutic areas, with a year-over-year revenue increase of 6.1% [7][8] - **Medical Devices**: Anticipated to show significant growth, driven by the Diabetes Care division and continuous glucose monitor (CGM) systems, with a projected revenue increase of 10.9% year-over-year [8][9][13] - **Nutrition**: Expected robust sales from adult nutrition brand Ensure and solid growth in infant formula and toddler brands, with a year-over-year revenue improvement of 4.3% [13] Earnings Estimate Revision - Estimates for Q2 earnings have remained unchanged at $1.25 per share over the past 30 days, indicating stability in expectations [3] Market Position and Growth Drivers - The Medical Devices segment is highlighted as a standout performer, with growth driven by new product approvals and strong demand in various categories, including heart assist devices and structural heart products [10][11][12]
ABT's FreeStyle Libre 3 Plus Now Available in Canada: Stock to Rise?
ZACKS· 2025-07-10 13:26
Company Overview - Abbott Laboratories has launched its FreeStyle Libre 3 Plus sensor for diabetes management in Canada, featuring the world's smallest glucose sensor, which is expected to enhance the company's Diabetes Care business [1][8] - The FreeStyle Libre system has achieved global leadership in continuous glucose monitoring (CGM) for both Type 1 and Type 2 diabetes users, contributing positively to Abbott's market sentiment [3][8] Financial Performance - Abbott's market capitalization stands at $231.78 billion, with an earnings yield of 3.9%, significantly higher than the industry average of 0.6% [4] - Over the past year, Abbott's shares have increased by 29.3%, outperforming the industry growth of 11.6% [10] Product Significance - The FreeStyle Libre 3 Plus simplifies glucose monitoring, allowing users to track glucose levels in real-time via a smartphone app, which is crucial for effective diabetes management [5][6] - Approximately 12 million Canadians live with diabetes, with around 90% having Type 2 diabetes, highlighting the importance of glucose monitoring in this demographic [5] Industry Prospects - The global CGM devices market is projected to reach $7.51 billion by 2030, growing at a CAGR of 7.19% from 2024 to 2030, driven by the rising prevalence of diabetes and increasing demand for treatment [7]
Abbott Stock Gains Following FDA Approval of the Tendyne System
ZACKS· 2025-05-28 14:25
Core Viewpoint - Abbott Laboratories has received FDA approval for its Tendyne transcatheter mitral valve replacement system, enhancing its Structural Heart portfolio and providing a minimally invasive solution for patients with severe mitral annular calcification [1][5][6]. Company Summary - Abbott's stock increased by 1.3% to $132.94 following the announcement of the Tendyne system approval [2]. - The company has a market capitalization of $231.29 billion and an earnings yield of 3.9%, significantly higher than the industry average of 0.6% [4]. - Abbott's Structural Heart division includes a diverse product range, such as MitraClip and TriClip, which positions the company favorably in the market [3]. Product Importance - The Tendyne system addresses mitral valve diseases caused by severe mitral annular calcification, offering a less invasive alternative for high-risk patients who may not be suitable for open-heart surgery [5]. - The system's innovative design allows for adaptability to various patient anatomies, with a self-expanding valve that can be repositioned during implantation [6]. Industry Prospects - The transcatheter mitral valve replacement market is expected to grow at a compound annual growth rate of 20% from 2025 to 2030, driven by the rising prevalence of mitral valve diseases and a preference for minimally invasive procedures [8]. Stock Performance - Over the past year, Abbott's shares have increased by 32%, outperforming the industry growth of 10.3% [11].