07.20.22
Rank: #23 (Last year: #22)
$5.23 Billion
Prior Fiscal: $4.39 Billion
Percentage Change: +19.3%
R&D Expenditure: $903M
Best FY21 Quarter: Q2 $1.38B
Latest Quarter: Q1 $1.34B
No. of Employees: 15,700
Global Headquarters: Irvine, Calif.
KEY EXECUTIVES:
Michael A. Mussallem, Chairman and CEO
Scott B. Ullem, Corp. VP, CFO
Todd J. Brinton, MD, F.A.C.C., Corp. VP, Advanced Technology, CSO
Daveen Chopra, Corp. VP, Surgical Structural Heart
Katie M. Szyman, Corp. VP, Critical Care
Larry L. Wood, Corp. VP, Transcatheter Aortic Valve Replacement
Bernard J. Zovighian, Corp. VP, Transcatheter Mitral and Tricuspid Therapies
Edwards Lifesciences’ 2021 annual report introduces a man named Jim who enjoys the outdoors through hiking, swimming, cycling, and skiing. In 2020, he started to notice that he was experiencing shortness of breath and limited exercise capacity when he was engaging in such activities.
“Just climbing a flight of stairs was starting to bother me,” he explained. “My first attempt of a winter ascent of Mt. Washington fell short.”
As a result of the COVID-19 pandemic, his cardiology checkup was cancelled and other appointments delayed (a common tale for too many). He was ultimately diagnosed with severe aortic stenosis and recommended to reduce his active lifestyle. A heart team finally determined he was qualified for a transcatheter aortic valve replacement (TAVR).
He received the SAPIEN 3 valve on Dec. 17, 2020, and after only a few days, felt like he “got his life back.” A week after the one-night stay in a hospital for the procedure, he was back to his normal routine, activities included, with no restrictions.
TAVR is the primary focus for Edwards Lifesciences, with the division accounting for much more than half of all of the firm’s sales. In fiscal 2021, it represented a $3.42 billion contribution, which was a 19.8% gain over the previous year. As was the case for so many medical device firms, the increase resulted from the return of more elective procedures as the conditions created by the COVID-19 pandemic eased.
In December, the organization gained another regulatory approval for its SAPIEN 3 Transcatheter Pulmonary Valve (TPV) technology. This one was specifically tied to the use of the transcatheter valve with the Alterra adaptive prestent for patients with severe pulmonary regurgitation. The Alterra prestent compensates for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the SAPIEN 3 valve.
The company also sought to shore up clinical evidence supporting its technology. News was provided on a number of trials where the effectiveness of TAVR was further verified.
One such report involved new data from the COMMENCE clinical trial that demonstrated Edwards’ bioprosthetic surgical aortic valve with the company’s novel RESILIA tissue platform showed favorable safety and hemodynamic performance through a median of five years follow-up.
Another presented the results of a real-world study comparing outcomes for patients with bicuspid aortic stenosis who were treated with SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Aortic Valve Replacement and at low risk of death from surgery. The data showed excellent outcomes at one year, with low rates of death and stroke, and no significant differences in the primary outcomes compared with the overall cohort, or those with tricuspid aortic valve disease.
Edwards’ Transcatheter Mitral and Tricuspid Therapies unit doubled in revenue for the fiscal year 2021 as compared to the previous period. Specifically, the business grew 105.5% to finish at $86 million. The firm again pointed to the return of more procedures following the relaxing of COVID-19 restrictions and limitations.
For this business, Edwards also shared results of clinical trials that furthered the clinical evidence supporting the technology. The 30-day outcomes from the TRISCEND study of the transfemoral EVOQUE tricuspid valve replacement system demonstrated technical feasibility and an acceptable safety profile, along with improvements in tricuspid regurgitation (TR) as well as symptoms in patients with clinically significant TR. At six months, the following findings were reported:
The organization’s other two divisions, Surgical Heart Valve Therapy and Critical Care, both saw positive gains for the same reasons as the previous two—return of elective procedures within hospitals. Surgical Heart Valve Therapy blossomed 16.7% to contribute $889 million to the company’s coffers. Critical Care saw similar growth, with a percentage gain of 15.1. That figure translated to a fiscal year 2021 total of $835 million.
Speaking of Critical Care, the unit announced its Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff received FDA clearance in June. The noninvasive solution unlocks Acumen HPI software and uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Previously, Acumen HPI software was only available for patients using an invasive arterial line.
In August, Edwards Lifesciences established a Social Impact Investment Fund in order to expand access to capital in underserved communities. The $100 million fund was created as a new portfolio of investments aimed at the advancement of racial equity through economic development, especially in predominantly black and underserved communities in the United States.
“Events in 2020 prompted reflection on how we could expand Edwards’ active community engagement to provide even more support for our employees and communities, particularly as it relates to social equity and justice,” said Scott Ullem, CFO. “We believe that increasing the availability of capital in underserved areas can contribute to a virtuous cycle of job creation, wealth-building, and other new opportunities for economic development, while also providing a return to investors.”
$5.23 Billion
Prior Fiscal: $4.39 Billion
Percentage Change: +19.3%
R&D Expenditure: $903M
Best FY21 Quarter: Q2 $1.38B
Latest Quarter: Q1 $1.34B
No. of Employees: 15,700
Global Headquarters: Irvine, Calif.
KEY EXECUTIVES:
Michael A. Mussallem, Chairman and CEO
Scott B. Ullem, Corp. VP, CFO
Todd J. Brinton, MD, F.A.C.C., Corp. VP, Advanced Technology, CSO
Daveen Chopra, Corp. VP, Surgical Structural Heart
Katie M. Szyman, Corp. VP, Critical Care
Larry L. Wood, Corp. VP, Transcatheter Aortic Valve Replacement
Bernard J. Zovighian, Corp. VP, Transcatheter Mitral and Tricuspid Therapies
Edwards Lifesciences’ 2021 annual report introduces a man named Jim who enjoys the outdoors through hiking, swimming, cycling, and skiing. In 2020, he started to notice that he was experiencing shortness of breath and limited exercise capacity when he was engaging in such activities.
“Just climbing a flight of stairs was starting to bother me,” he explained. “My first attempt of a winter ascent of Mt. Washington fell short.”
As a result of the COVID-19 pandemic, his cardiology checkup was cancelled and other appointments delayed (a common tale for too many). He was ultimately diagnosed with severe aortic stenosis and recommended to reduce his active lifestyle. A heart team finally determined he was qualified for a transcatheter aortic valve replacement (TAVR).
He received the SAPIEN 3 valve on Dec. 17, 2020, and after only a few days, felt like he “got his life back.” A week after the one-night stay in a hospital for the procedure, he was back to his normal routine, activities included, with no restrictions.
TAVR is the primary focus for Edwards Lifesciences, with the division accounting for much more than half of all of the firm’s sales. In fiscal 2021, it represented a $3.42 billion contribution, which was a 19.8% gain over the previous year. As was the case for so many medical device firms, the increase resulted from the return of more elective procedures as the conditions created by the COVID-19 pandemic eased.
In December, the organization gained another regulatory approval for its SAPIEN 3 Transcatheter Pulmonary Valve (TPV) technology. This one was specifically tied to the use of the transcatheter valve with the Alterra adaptive prestent for patients with severe pulmonary regurgitation. The Alterra prestent compensates for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the SAPIEN 3 valve.
The company also sought to shore up clinical evidence supporting its technology. News was provided on a number of trials where the effectiveness of TAVR was further verified.
One such report involved new data from the COMMENCE clinical trial that demonstrated Edwards’ bioprosthetic surgical aortic valve with the company’s novel RESILIA tissue platform showed favorable safety and hemodynamic performance through a median of five years follow-up.
Another presented the results of a real-world study comparing outcomes for patients with bicuspid aortic stenosis who were treated with SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Aortic Valve Replacement and at low risk of death from surgery. The data showed excellent outcomes at one year, with low rates of death and stroke, and no significant differences in the primary outcomes compared with the overall cohort, or those with tricuspid aortic valve disease.
Edwards’ Transcatheter Mitral and Tricuspid Therapies unit doubled in revenue for the fiscal year 2021 as compared to the previous period. Specifically, the business grew 105.5% to finish at $86 million. The firm again pointed to the return of more procedures following the relaxing of COVID-19 restrictions and limitations.
For this business, Edwards also shared results of clinical trials that furthered the clinical evidence supporting the technology. The 30-day outcomes from the TRISCEND study of the transfemoral EVOQUE tricuspid valve replacement system demonstrated technical feasibility and an acceptable safety profile, along with improvements in tricuspid regurgitation (TR) as well as symptoms in patients with clinically significant TR. At six months, the following findings were reported:
- Significant reduction in TR severity, with 100% of patients with none/trace or mild TR in 43 patients with paired echocardiographic data available
- Significantly improved functional and quality-of-life outcomes, including 89% of patients in NYHA Class I or II, and a 27-point increase in KCCQ score over baseline
- High survival rate of 96%, and freedom from heart failure hospitalization of 94%
The organization’s other two divisions, Surgical Heart Valve Therapy and Critical Care, both saw positive gains for the same reasons as the previous two—return of elective procedures within hospitals. Surgical Heart Valve Therapy blossomed 16.7% to contribute $889 million to the company’s coffers. Critical Care saw similar growth, with a percentage gain of 15.1. That figure translated to a fiscal year 2021 total of $835 million.
Speaking of Critical Care, the unit announced its Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff received FDA clearance in June. The noninvasive solution unlocks Acumen HPI software and uses machine learning to alert clinicians of the likelihood a patient is trending toward hypotension, or low blood pressure. Previously, Acumen HPI software was only available for patients using an invasive arterial line.
In August, Edwards Lifesciences established a Social Impact Investment Fund in order to expand access to capital in underserved communities. The $100 million fund was created as a new portfolio of investments aimed at the advancement of racial equity through economic development, especially in predominantly black and underserved communities in the United States.
“Events in 2020 prompted reflection on how we could expand Edwards’ active community engagement to provide even more support for our employees and communities, particularly as it relates to social equity and justice,” said Scott Ullem, CFO. “We believe that increasing the availability of capital in underserved areas can contribute to a virtuous cycle of job creation, wealth-building, and other new opportunities for economic development, while also providing a return to investors.”