Fourth-quarter and full-year 2025 results | Adjusted diluted EPS | | | | --- | --- | --- | | Fourth quarter | $1.501 | ↑12% | | Full year | $5.152 | % ↑10 | | W orldwide sales | Organic* sales growth for underlying base business** | 5 Full-year 2026 guidance | | $11.5B | ↑3.8%3 | 6.5% to 7.5% | | Fourth quarter | | Organic sales growth | | $44.3B | ↑6.7%4 | $5.55 to $5.80 | | Full year | | Adjusted diluted EPS | Key business units | Fourth-quarter sales Expanding in the fast-growing pulsed field ablation (P ...

Core Insights - Abbott reported strong financial results for Q4 2025, with total worldwide sales reaching $11.459 billion, a 4.4% increase from Q4 2024 [28] - The company achieved double-digit earnings per share growth, with adjusted diluted EPS of $1.50, reflecting a 12% increase [5] - Abbott's full-year 2025 sales totaled $44.328 billion, marking a 5.7% increase compared to 2024 [28] Financial Performance - Q4 2025 sales increased 4.4% on a reported basis and 3.0% on an organic basis, with a 3.8% increase when excluding COVID-19 testing-related sales [5][28] - Full-year 2025 GAAP diluted EPS was $3.72, while adjusted diluted EPS was $5.15, reflecting a 10% growth [5][28] - Abbott projects full-year 2026 organic sales growth to be in the range of 6.5% to 7.5% and adjusted diluted EPS of $5.55 to $5.80 [5][22] Segment Performance - In Q4 2025, Nutrition sales decreased by 8.9% on a reported basis and 9.1% on an organic basis, primarily due to lower sales volumes [9][10] - Diagnostics sales in Q4 2025 were $2.457 billion, a decrease of 2.5% on a reported basis and 3.6% on an organic basis [12][28] - Medical Devices sales increased by 12.3% on a reported basis and 10.4% on an organic basis, driven by strong growth in Electrophysiology and Diabetes Care [19][20] Strategic Developments - Abbott announced an agreement to acquire Exact Sciences, positioning the company to enter the cancer diagnostics market [5] - The company received FDA approval for its Volt™ PFA System and CE Mark for its TactiFlex™ Duo Ablation Catheter, enhancing its Electrophysiology portfolio [5][10] Dividend Information - Abbott declared a quarterly dividend of $0.63 per share, marking the 408th consecutive quarterly dividend and reflecting a commitment to returning value to shareholders [24]

Core Insights - Abbott Laboratories has received FDA approval for its Volt™ PFA System to treat atrial fibrillation (AFib), marking a significant advancement in its product offerings [2][4] - The Volt PFA System is expected to be commercially available in the U.S. soon, with plans for expansion in the European Union following prior CE Mark approval [2] - AFib affects approximately 12 million people in the U.S. over the age of 65, with projections indicating this number could double in the next 20 years, highlighting a growing market for treatment options [3] FDA Approval and Clinical Study - The FDA approval was based on the VOLT-AF IDE study, which included 392 patients across 40 centers in the U.S., Europe, Canada, and Australia [4] - The study demonstrated that the Volt PFA System provided clinically meaningful safety and effectiveness for patients with both paroxysmal and persistent AFib [4] Company Overview - Abbott Laboratories is recognized as a global healthcare leader, offering a diverse portfolio that includes diagnostics, medical devices, nutritionals, and branded generic medicines [5]

Core Insights - Abbott Laboratories has received FDA approval for its Volt™ PFA System to treat atrial fibrillation (AFib), marking a significant advancement in its cardiovascular portfolio and enabling commercial procedures in the U.S. and Europe [1][3] - The prevalence of AFib is increasing, with approximately 12 million Americans over 65 currently affected, a number expected to double in the next 20 years, highlighting the urgent need for effective treatment solutions [2] - The FDA approval is anticipated to enhance Abbott's market position in the expanding AFib market, potentially increasing procedure volumes and recurring revenues, while also supporting margin expansion [3] Company Overview - Abbott is a global healthcare leader with a market capitalization of approximately $218.1 billion, operating in over 160 countries across various sectors including cardiovascular care, diabetes management, diagnostics, nutrition, and neuromodulation [4] - The stock has experienced a year-to-date gain of nearly 10.35%, although it has seen a decline of 8.15% over the past three months, indicating fluctuating investor sentiment [4] Financial Metrics - Abbott's stock is trading at 24.36 times forward adjusted earnings and 4.87 times sales, which is above industry averages, reflecting strong investor confidence in its earnings durability and long-term growth prospects [5] - The company has increased its quarterly common dividend to $0.63 per share, a 6.8% increase, marking the 54th consecutive year of dividend growth [6]

Core Insights - Abbott has received FDA approval for its Volt PFA System to treat atrial fibrillation (AFib), with plans to begin commercial cases in the U.S. and expand in the EU following earlier CE Mark approval [1][2] - Approximately 12 million people in the U.S. over the age of 65 have AFib, a number expected to double in the next 20 years, highlighting the growing need for effective treatment options [1] - The Volt PFA System demonstrated strong safety and effectiveness in the VOLT-AF IDE study, which included 392 patients across multiple countries [2] Product Features - The Volt PFA System is designed to simplify AFib treatment by allowing physicians to map, pace, and ablate using a single catheter, enhancing workflow and efficiency [4][5] - Its unique balloon-in-basket design provides superior tissue contact and energy delivery, addressing limitations of earlier PFA systems [3][4] - The system allows for fewer therapy applications, which can lead to better patient outcomes and reduced risk of complications [7] Clinical Benefits - The Volt PFA System supports conscious sedation instead of general anesthesia, which can facilitate faster recovery times for patients undergoing ablation procedures [7][8] - It reduces exposure to radiation and minimizes hemolysis, making it a safer option for patients [7] - The system is clinically proven to achieve durable lesions with fewer pulses, enhancing the effectiveness of first-time procedures [6][7]

Core Insights - Abbott has announced strong safety and efficacy data from its Volt CE Mark Study for the Volt™ PFA System, demonstrating positive results for patients with atrial fibrillation (AFib) over a 12-month period [1][6] Group 1: Study Findings - The Volt CE Mark Study showed that the Volt PFA System achieved an average of 4.7 therapy applications per vein, which is fewer than competitive PFA systems [1] - After 12 months, 83.5% of patients with paroxysmal atrial fibrillation (PAF) and 58.1% of patients with persistent AFib (PersAF) remained free from atrial arrhythmia, indicating one of the lowest recurrence rates in long-term PFA studies [7] - Quality of life (QoL) scores improved significantly from 64.1 to 88.1 after 12 months of treatment [7] Group 2: Safety Profile - The Volt PFA System demonstrated an excellent safety profile, with only 2.7% of patients experiencing a primary safety endpoint event, and no cases of hemolysis, coronary artery spasm, pulmonary vein stenosis, acute kidney injury, or phrenic nerve injury reported [7] - The study confirmed that the Volt PFA System can effectively treat both PAF and PersAF patients, enhancing procedural flexibility with options for light sedation or general anesthesia [4][8] Group 3: Study Design - The Volt CE Mark Study is a prospective, single-arm, non-randomized, multicenter study that enrolled 150 patients across 11 sites in Europe, focusing on symptomatic, recurrent, drug-refractory PAF and PersAF [8]

Core Insights - Abbott has received CE Mark approval for the Volt™ PFA System, enabling the treatment of atrial fibrillation (AFib) in Europe, with commercial cases already initiated [1][3] - The Volt PFA System is designed to improve the workflow of cardiac ablation procedures by utilizing a single-catheter approach, which allows for mapping, pacing, and ablating simultaneously [2][8] - The Volt PFA System demonstrated a 99.1% success rate in achieving pulmonary vein isolation (PVI) during clinical trials, outperforming existing competitive systems [3][10] Company Developments - Abbott has begun commercial use of the Volt PFA System in the EU, with plans for further expansion in the second half of the year [1] - Initial cases were performed by leading physicians in various European hospitals, indicating strong clinical interest and early adoption [3][4] - The Volt PFA System is part of Abbott's broader electrophysiology portfolio, which includes ongoing clinical studies and regulatory approvals for related technologies [11][12] Market Context - Approximately 8 million Europeans over 65 are currently living with AFib, a number projected to double in the next 30 years, highlighting a significant market opportunity for effective treatment solutions [2] - The Volt PFA System addresses limitations of existing PFA systems by providing enhanced visualization and navigation capabilities, which can lead to improved patient outcomes [6][10] - The integration of the Volt PFA System with Abbott's EnSite™ X EP system enhances procedural efficiency and accuracy, positioning Abbott favorably in the competitive landscape of electrophysiology [6][9]