Edwards Lifesciences Corp

Edwards Lifesciences Corporation is the leading global structural heart innovation company, driven by a passion to improve patient lives. Cardiovascular disease is the number-one cause of death in the world and is the top disease in terms of health care spending in nearly every country. In the U.S. alone, one cardiovascular patient dies every 34 seconds ¹. The company's vision is to transform patient care where patients are diagnosed earlier, treated in a routine fashion, live longer, and enjoy a better quality of life. Future growth opportunities include offering solutions for treating patients with both valvular and non-valvular structural heart disease, such as heart failure, which is an unfortunate natural progression of the disease for many patients suffering from aortic stenosis, mitral and tricuspid regurgitation, and aortic regurgitation.

The medical technology industry is highly competitive. In TAVR, the company's primary competitors include Medtronic plc and Abbott Laboratories. In TMTT, the primary competitor is Abbott, and there are a considerable number of large and small companies with development efforts in these fields. In Surgical, the primary competitors include Medtronic and Abbott. The company believes it is a leading global competitor in each of its product lines. The cardiovascular segment of the medical technology industry is dynamic and subject to significant change due to cost-of-care considerations, regulatory reform, industry and customer consolidation, and evolving patient needs.

The company generates revenue through the sale of medical technologies designed to address individual patient needs with respect to disease process, comorbidities, and health status. Products are sold to hospitals and other health care providers, nearly all of which receive reimbursement for health care services from third-party payors. The company's distribution system consists of several direct sales forces as well as independent distributors. No single customer accounted for 10% or more of net sales in 2025 ². In the United States, substantially all products are sold through direct sales forces. Outside of the United States, sales are made through direct sales forces and independent distributors.

The company's products are categorized into three groups: Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Mitral and Tricuspid Therapies (TMTT), and Surgical Structural Heart (Surgical). The Edwards SAPIEN family of valves remains a best-in-class therapy for lifetime management of patients with severe aortic stenosis. The SAPIEN valves are delivered while the heart is still beating, and the majority of procedures are conducted without general anesthesia with patients discharged home within one to two days. Edwards' transcatheter aortic heart valves were first commercialized in Europe in 2007, in the United States in 2011, and in Japan in 2013. The SAPIEN 3 platform was the world's first transcatheter heart valve with a THV-in-THV indication for patients assessed at high-risk for surgical replacement. SAPIEN is the most studied valve in the world, with more than 15 years of clinical trials involving over 10,000 patients ³, 10 New England Journal of Medicine publications ⁴ and 1.2 million patients treated around the world ⁵. Sales of TAVR products represented 74% ⁶, 75% ⁷, and 77% ⁸ of net sales in 2025, 2024, and 2023, respectively.

In TMTT, the company has commercialized a unique portfolio of therapies including the PASCAL, EVOQUE and SAPIEN M3 systems. The PASCAL transcatheter repair system is available in Europe, the United States, and Japan. The EVOQUE tricuspid valve replacement system, the world's first transcatheter tricuspid valve replacement therapy to receive regulatory approval, is available in Europe and the United States. The SAPIEN M3 mitral valve replacement system is available in Europe and the United States. Sales of TMTT products represented 9% ⁹, 7% ¹⁰, and 4% ¹¹ of net sales in 2025, 2024, and 2023, respectively. In Surgical, the company's flagship INSPIRIS RESILIA aortic valve offers RESILIA tissue and VFit technology, and INSPIRIS is the leading aortic surgical valve in the world. The KONECT RESILIA aortic valved conduit was launched in Europe in 2025. The MITRIS RESILIA valve is commercially available in the United States, Europe, Japan and China. Sales of surgical tissue heart valve products represented 17% ¹², 18% ¹³, and 19% ¹⁴ of net sales in 2025, 2024, and 2023, respectively.

On September 3, 2024 ¹⁵, the company sold its Critical Care product group to Becton, Dickinson and Company. On December 18, 2025 ¹⁶, the company completed the sale of a business that is not focused on implantable medical innovations for structural heart disease (the non-core product group). The historical financial condition and results of the discontinued product groups have been reflected as discontinued operations. In August 2024, the Board of Directors approved a stock repurchase program providing for up to $1.5 billion ¹⁷ of repurchases of common stock. In September 2025, the Board of Directors approved up to an additional $1.5 billion ¹⁸ of repurchases under this program. Research and development spending increased approximately 2% ¹⁹ year over year, representing approximately 18% ²⁰ of 2025 sales.

Net sales for 2025 were $6.1 billion ²¹, representing an increase of $628.1 million ²² over 2024. Gross profit increased in 2025, driven by sales growth. Gross profit as a percentage of sales decreased primarily due to higher operational expenses. The company had approximately 16,000 employees worldwide as of December 31, 2025 ²³.

In TAVR, the company is developing new products to further improve and streamline transcatheter aortic heart valve replacement procedures. The company's leadership strategy of differentiated innovation, world-class evidence generation and indication expansion is driving guideline and policy evolution and improved patient access and long-term adoption of the SAPIEN platform. In 2024, EARLY TAVR trial data demonstrated the superiority of early TAVR intervention in severe asymptomatic aortic stenosis patients with the SAPIEN 3 platform versus clinical surveillance ²⁴.

In TMTT, the company is making significant investments in innovation and clinical evidence to develop technologies designed to treat mitral and tricuspid valve diseases. The company remains committed to its strategy of transformative product innovation, robust and expanding clinical evidence to support approvals and adoption, as well as comprehensive support to ensure excellent real-world patient outcomes. Future growth opportunities include offering solutions for treating patients with both valvular and non-valvular structural heart disease, such as heart failure, which is a natural progression of the disease for many patients suffering from aortic stenosis, mitral and tricuspid regurgitation and aortic regurgitation.

Research and development spending increased approximately 2% ²⁵ year over year, representing approximately 18% ²⁶ of 2025 sales. This increase was primarily the result of significant investments in transcatheter structural heart programs, including an increase in clinical research for mitral, aortic, and tricuspid therapies. The company's research and development activities are conducted primarily in facilities located in the United States and Israel.

The company operates manufacturing facilities in various geographies around the world, manufacturing TAVR, TMTT, and Surgical products primarily in the United States, Singapore, Costa Rica, and Ireland. The company uses a diverse and broad range of raw and organic materials and purchases certain materials and components from external suppliers, including from single sources. Alternative supplier options are generally considered for materials deemed critical to products, though the company does not typically pursue immediate regulatory qualification of alternative sources due to the time and expense associated with the regulatory validation process.

Research and development spending increased approximately 2% ²⁷ year over year, representing approximately 18% ²⁸ of 2025 sales. In August 2024, the Board of Directors approved a stock repurchase program providing for up to $1.5 billion ²⁹ of repurchases of common stock. In September 2025, the Board of Directors approved up to an additional $1.5 billion ³⁰ of repurchases under this program. The repurchase program does not have an expiration date. The company has never paid any cash dividends on its capital stock and has no current plans to pay any cash dividends.

The company faces risks from global economic, political and social conditions, including inflation, credit and capital markets, interest rates, tax law changes, tariffs, and the political environment relating to health care. The current tariff environment is dynamic, as the U.S. government has imposed, modified and paused tariffs multiple times since the beginning of 2025. Tariffs may cause increases in manufacturing costs, disruptions or delays to the supply chain, limitations on the ability to sell products domestically or abroad, and reductions in sales volumes and gross margins. The company is also subject to risks associated with public health crises, including pandemics and epidemics.

The company faces risks related to its international operations, including trade protection measures, quotas, embargoes, import or export requirements, duties, tariffs, or surcharges, cultural or local factors, global regulations, military conflict, political unrest, or wars, scrutiny from governmental bodies regarding product pricing, and currency exchange rate fluctuations. Decreases in the value of the United States dollar to the Euro or the Japanese yen have the effect of increasing reported sales, while increases have the opposite effect. The company is also subject to risks from the inability to obtain government reimbursement or reductions in reimbursement levels, and from industry consolidation.

The company faces material risks from failure to successfully innovate and develop new and differentiated products in a timely manner, as without timely innovation, products could be rendered obsolete or less competitive. Unsuccessful clinical trials or procedures could have a material adverse effect on prospects, as the regulatory approval process requires extensive clinical trials and procedures that are inherently uncertain. Manufacturing, logistics, safety, or quality problems could result in safety alerts, recalls, product liability costs, and delayed product approvals. The company operates in highly competitive markets and competes with technologies of many types and companies of all sizes. The company relies on third parties for a broad range of raw and organic materials and purchases certain supplies and services from single sources, and any failure by or loss of a vendor could result in delays and increased costs. The company is subject to risks from cybersecurity attacks, network security breaches, service interruptions, or data corruption that could materially disrupt operations. The company is also subject to risks from the inability to protect intellectual property, as patents may be challenged and held invalid, and confidentiality agreements may be breached.

Management's message emphasizes the company's position as the leading global structural heart innovation company, driven by a passion to improve patient lives. The company remains committed to its strategy of transformative product innovation, high-quality, expansive clinical evidence to support approvals and adoption, as well as comprehensive support to ensure excellent real-world patient outcomes. Key strategic priorities include continuing to deliver the most predictable, durable and trusted TAVR therapy, making significant progress addressing the complex unmet needs of patients with mitral and tricuspid disease with a differentiated portfolio, and advancing leadership in surgical therapies with innovations like RESILIA tissue technology.