Edwards Lifesciences Corporation

“Edwards Lifesciences Corporation is the leading global structural heart innovation company, driven by a passion to improve patient lives.”

“Our differentiated RESILIA tissue technology, with published clinical data showing over 99% freedom from structural valve deterioration through eight years, has set the new standard for tissue valve durability.”

“The Edwards SAPIEN family of valves remains a best-in-class therapy for lifetime management of patients with severe aortic stenosis.”

“The company has successfully commercialized a unique portfolio of therapies, including the PASCAL, EVOQUE and SAPIEN M3 systems, transforming care by enabling personalized therapy.”

“United States$3,543.1 $3,206.0 $337.1 10.5 %”

“Transcatheter Aortic Valve Replacement$4,487.7 $4,106.1 $381.6 9.3 %”

“Sales of our TAVR products represented 74%, 75%, and 77% of our net sales in 2025, 2024, and 2023, respectively.”

“foreign currency exchange rate fluctuations increased net sales outside of the United States by $26.7 million primarily due to the strengthening of the Euro against the United States dollar.”

“As of December 31, 2025, we had approximately 16,000 employees worldwide, the majority of whom were located in the United States, Singapore, and Costa Rica.”

“The purchase consideration for the acquisition of Innovalve was $380.9 million”

“the Company acquired the remaining noncontrolling interest of Vectorious for $233.7 million, increasing the Company's total ownership from 61% to 100%.”

“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.”

“Net sales of TAVR products increased in 2025, driven by higher sales of the Edwards SAPIEN platform in 2025, primarily due to higher sales of the Edwards SAPIEN 3 Ultra RESILIA valve in the United States and Europe.”

“On September 3, 2024, we sold our Critical Care product group ("Critical Care") to Becton, Dickinson and Company ("BD").”

“On December 18, 2025, we completed the sale of a business that is not focused on implantable medical innovations for structural heart disease (the "non-core product group").”

“SAPIEN is the most studied valve in the world, with more than 15 years of distinguished clinical trials involving over 10,000 patients, 10 New England Journal of Medicine publications and 1.2 million patients treated around the world.”

“In 2025, we invested 18% of our net sales in research and development.”

“Our vision for growth is to treat 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 and mitral and tricuspid regurgitation.”

“We incurred certain expenses related to legal settlement and contingency, intellectual property litigation, and tax litigation of $325.4 million and $40.4 million during 2025 and 2024, respectively.”

“The decrease in our net income and diluted earnings per share in 2025 was driven primarily by increases in personnel-related costs, one-time charges related to impairments on our investments, and increased certain litigation expenses.”

“we received United States Food and Drug Administration ("FDA") approval for the SAPIEN 3 platform for severe aortic stenosis patients without symptoms;”

“In December 2025, the Company also recorded an impairment loss on JenaValve's Bridge Loan of $99.8 million, including accrued interest.”

“Without timely innovation and development, our products could be rendered obsolete or less competitive because of the introduction of a competitor's newer technologies or changing customer preferences.”

“The manufacture and sterilization of many of our products are highly complex due in part to rigorous regulatory requirements.”

“We have in the past and are continuing to experience constrained procedure volumes and sales for our products because more products, including Edwards' own products, are competing for the same facilities and staffing within hospitals.”

“restrictive requirements in the U.S. national coverage determination for transcatheter aortic valve replacement procedures”

“Clinical trials or procedures may be delayed, suspended, or terminated by us, the FDA, or other regulatory authorities at any time”

“The success of many of our products depends upon certain key physicians, research institutions, and hospital systems.”

“The GDPR imposes stringent EU data protection requirements and provides for significant penalties for noncompliance.”

“many countries are aligning their international tax rules with the Organisation for Economic Co-operation and Development's Base Erosion and Profit Shifting Pillar Two recommendations”

“Use of, or failure to effectively and timely utilize, emerging technologies, including artificial intelligence ("AI")”

“Many of the devices we manufacture and sell are designed to be implanted in the human body for long periods of time.”