07.22.21
Rank: #22 (Last year: #23)
$4.39 Billion
Prior Fiscal: $4.35 Billion
Percentage Change: +1%
No. of Employees: 14,900 (total)
Global Headquarters: Irvine, Calif.
KEY EXECUTIVES:
Michael A. Mussallem, Chairman and CEO
Scott B. Ullem, Corp. VP, CFO
Donald E. Bobo, Jr., Corp. VP, Strategy & Corporate Development
Todd J. Brinton, M.D., F.A.C.C., Corp. VP, Advanced Technology, Chief Scientific Officer
Daveen Chopra, Corp. VP, Surgical Structural Heart
Jean-Luc Lemercier, Corp. VP, EMEA, Canada, and Latin America
Joseph Nuzzolese, Corp. VP, Global Supply Chain
Gary I. Sorsher, Corp. VP, Quality and Regulatory Compliance
Katie M. Szyman, Corp. VP, Critical Care
Huimin Wang, M.D., Corp. VP, Japan, Asia and Pacific
Larry L. Wood, Corp. VP, Transcatheter Aortic Valve Replacement
Bernard J. Zovighian, Corp. VP, Transcatheter Mitral and Tricuspid Therapies
2020 wasn’t a smooth ride for Edwards Lifesciences. While the company faced COVID-19 pandemic challenges, including elective surgeries being paused and determining how to best keep employees safe while still supplying medical technologies, the firm was involved in spats with device makers.
One such challenge involved a patent dispute with Abbott over intellectual property related to mitral valve repair devices. It was Edwards’ stance the IP should be deemed unpatentable. The Patent Trial and Appeal Board rejected Edwards’ claims, which are tied to an Abbott acquisition, Evalve—the original manufacturer of the MitraClip. The decision was one in a string of legal challenges made by Edwards against Abbott’s device.
A few months later, Edwards’ Pascal transcatheter mitral valve repair (TMVR) device was barred from sale in the U.K. Further, a judge for the High Court of England and Wales determined the Pascal device infringed on two Abbott patents for its MitraClip. Although Edwards argued the devices were dissimilar enough, the court only allowed the device to be indicated for patients who were not a match for the MitraClip.
Finally, in July 2020, the two organizations agreed to settle litigation involving all patent disputes related to transcatheter mitral and tricuspid repair products. Per the agreement, all pending cases and appeals in courts and patent offices worldwide would be dismissed. In addition, no new litigation over patent disputes of the specific technologies would occur for 10 years. Also, any injunctions that were currently still in effect would be lifted.
While details of the settlement were confidential, multiple online news reports detailing the arrangement cite an Edwards filing as a source of additional information (since removed). In the filing, Edwards allegedly agreed to pay $368 million upfront to settle the disputes, and about $100 million in royalties through mid-2024.
Later in the year, Medtronic issued its own challenge in the form of a study to compare its Evolut TAVR platform to Edwards’ SAPIEN valve in small annulus patients. Specifically, the SMART post-market trial aimed to compare valve safety and performance of the self-expanding Medtronic Evolut PRO and PRO+TAVR Systems against the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves manufactured by Edwards.
According to Medtronic, the study would enroll roughly 700 patients worldwide. It would evaluate valve performance in patients with small annuli and candidates for TAV-in-SAV procedures (transcatheter valve implanted inside of a failed surgical valve), which combined represent over 40 percent of the TAVR market. The trial was slated to begin in April 2021; it has a primary completion date of May 2023 and study completion date of May 2028.
Regardless of the challenges, Edwards Lifesciences still enjoyed a positive year from a revenue standpoint. Considering the stoppage put on elective surgeries during the COVID-19 pandemic, Edwards’ 1 percent growth over the prior fiscal was positive. The firm ended with $4.39 billion in net sales compared to $4.35 billion the previous year.
Within its four product groups, Transcatheter Aortic Valve Replacement led in revenue generation. The segment grew by 4.4 percent year over year, finishing 2020 at $2.86 billion versus $2.74 billion in 2019.
The primary reason for the increase, according to Edwards, were SAPIEN 3 Ultra System sales in both the U.S. and Europe. Sales weren’t what they could have been in a “normal” year due to COVID and the suspension of elective procedures. Further, the firm even paused proctoring of the Ultra System in Q1 2020 in centers where personnel weren’t trained on the product. Proctoring resumed during the second quarter of the year.
For the product group Transcatheter Mitral and Tricuspid Therapies, tremendous growth was seen in 2020. Exploding from $28.2 million to $41.8 million, the 48.5 percent increase was primarily due to sale of the PASCAL transcatheter valve repair system in Europe, where it gained its CE mark in 2019.
Unfortunately, the other two product categories went in the opposite direction. Surgical Heart Valve Therapy fell 9.5 percent to land at $762 million from $842 million. Edwards points to decreased sales of aortic tissue valves due to COVID-19 as the primary reason for the loss. The decline was offset slightly by increased sales of the INSPIRIS RESILIA aortic valve and the KONECT aortic valved conduit, primarily in the U.S., but it was not enough to absorb the deficit created.
Critical Care was only down 2 percent, seeing sales go from $740 million in 2019 to $725 million in 2020. Again, COVID-19 was attributed as the reason.
Regardless of the challenges Edwards may have faced in 2020, the organization still kept a view of future growth opportunities. As such, it celebrated several positive product announcements during the fiscal.
The SAPIEN 3 transcatheter heart valve gained Chinese regulatory approval to treat of patients suffering from severe, symptomatic aortic stenosis (AS) at high risk for or unable to undergo open-heart surgery.
"Now, in China, patients diagnosed with severe AS have the option of a shorter procedure with excellent clinical outcomes, including a more rapid recovery than open-heart surgery," said Prof. Junbo Ge, M.D., academician of the Chinese Academy of Sciences, chairman, Shanghai Institute of Cardiovascular Diseases and director, Department of Cardiology, Zhongshan Hospital, Fudan University.
The approval for high-risk and extreme-risk patients in China was supported by the China SAPIEN 3 study, which complements a highly robust set of clinical outcomes from three randomized controlled PARTNER studies, along with excellent real-world results.
In Europe, the PASCAL Transcatheter Valve Repair System was approved for tricuspid repair. The CE mark was gained specifically for treating patients with tricuspid regurgitation.
The PASCAL system is indicated in Europe for percutaneous tricuspid valve reconstruction through leaflet repair by tissue approximation. The clasps and paddles gently grasp the leaflets to facilitate coaptation, while the spacer is designed to fill the regurgitant orifice area and prevent backflow. The clasps can be operated independently to facilitate optimized leaflet capture and the implant can be elongated to a narrow profile, allowing for safe maneuvering in dense chordal anatomy.
The firm’s KONECT RESILIA aortic valved conduit, the first ready-to-implant solution for bio-Bentall procedures—a complex surgery that involves replacement of a patient's aortic valve, aortic root, and the ascending aorta—gained FDA approval in July. The device’s RESILIA tissue incorporates integrity-preservation technology that may help improve valve durability. The RESILIA tissue technology also allows devices to be stored under dry packaging conditions.
Health Canada approved the expanded use of Edwards’ SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves for the transfemoral treatment of patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open-heart surgery. Edwards said the SAPIEN 3 valves are the first transcatheter aortic valve implantation (TAVI) systems to gain this indication in Canada.
$4.39 Billion
Prior Fiscal: $4.35 Billion
Percentage Change: +1%
No. of Employees: 14,900 (total)
Global Headquarters: Irvine, Calif.
KEY EXECUTIVES:
Michael A. Mussallem, Chairman and CEO
Scott B. Ullem, Corp. VP, CFO
Donald E. Bobo, Jr., Corp. VP, Strategy & Corporate Development
Todd J. Brinton, M.D., F.A.C.C., Corp. VP, Advanced Technology, Chief Scientific Officer
Daveen Chopra, Corp. VP, Surgical Structural Heart
Jean-Luc Lemercier, Corp. VP, EMEA, Canada, and Latin America
Joseph Nuzzolese, Corp. VP, Global Supply Chain
Gary I. Sorsher, Corp. VP, Quality and Regulatory Compliance
Katie M. Szyman, Corp. VP, Critical Care
Huimin Wang, M.D., Corp. VP, Japan, Asia and Pacific
Larry L. Wood, Corp. VP, Transcatheter Aortic Valve Replacement
Bernard J. Zovighian, Corp. VP, Transcatheter Mitral and Tricuspid Therapies
2020 wasn’t a smooth ride for Edwards Lifesciences. While the company faced COVID-19 pandemic challenges, including elective surgeries being paused and determining how to best keep employees safe while still supplying medical technologies, the firm was involved in spats with device makers.
One such challenge involved a patent dispute with Abbott over intellectual property related to mitral valve repair devices. It was Edwards’ stance the IP should be deemed unpatentable. The Patent Trial and Appeal Board rejected Edwards’ claims, which are tied to an Abbott acquisition, Evalve—the original manufacturer of the MitraClip. The decision was one in a string of legal challenges made by Edwards against Abbott’s device.
A few months later, Edwards’ Pascal transcatheter mitral valve repair (TMVR) device was barred from sale in the U.K. Further, a judge for the High Court of England and Wales determined the Pascal device infringed on two Abbott patents for its MitraClip. Although Edwards argued the devices were dissimilar enough, the court only allowed the device to be indicated for patients who were not a match for the MitraClip.
Finally, in July 2020, the two organizations agreed to settle litigation involving all patent disputes related to transcatheter mitral and tricuspid repair products. Per the agreement, all pending cases and appeals in courts and patent offices worldwide would be dismissed. In addition, no new litigation over patent disputes of the specific technologies would occur for 10 years. Also, any injunctions that were currently still in effect would be lifted.
While details of the settlement were confidential, multiple online news reports detailing the arrangement cite an Edwards filing as a source of additional information (since removed). In the filing, Edwards allegedly agreed to pay $368 million upfront to settle the disputes, and about $100 million in royalties through mid-2024.
Later in the year, Medtronic issued its own challenge in the form of a study to compare its Evolut TAVR platform to Edwards’ SAPIEN valve in small annulus patients. Specifically, the SMART post-market trial aimed to compare valve safety and performance of the self-expanding Medtronic Evolut PRO and PRO+TAVR Systems against the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves manufactured by Edwards.
According to Medtronic, the study would enroll roughly 700 patients worldwide. It would evaluate valve performance in patients with small annuli and candidates for TAV-in-SAV procedures (transcatheter valve implanted inside of a failed surgical valve), which combined represent over 40 percent of the TAVR market. The trial was slated to begin in April 2021; it has a primary completion date of May 2023 and study completion date of May 2028.
Regardless of the challenges, Edwards Lifesciences still enjoyed a positive year from a revenue standpoint. Considering the stoppage put on elective surgeries during the COVID-19 pandemic, Edwards’ 1 percent growth over the prior fiscal was positive. The firm ended with $4.39 billion in net sales compared to $4.35 billion the previous year.
Within its four product groups, Transcatheter Aortic Valve Replacement led in revenue generation. The segment grew by 4.4 percent year over year, finishing 2020 at $2.86 billion versus $2.74 billion in 2019.
The primary reason for the increase, according to Edwards, were SAPIEN 3 Ultra System sales in both the U.S. and Europe. Sales weren’t what they could have been in a “normal” year due to COVID and the suspension of elective procedures. Further, the firm even paused proctoring of the Ultra System in Q1 2020 in centers where personnel weren’t trained on the product. Proctoring resumed during the second quarter of the year.
For the product group Transcatheter Mitral and Tricuspid Therapies, tremendous growth was seen in 2020. Exploding from $28.2 million to $41.8 million, the 48.5 percent increase was primarily due to sale of the PASCAL transcatheter valve repair system in Europe, where it gained its CE mark in 2019.
Unfortunately, the other two product categories went in the opposite direction. Surgical Heart Valve Therapy fell 9.5 percent to land at $762 million from $842 million. Edwards points to decreased sales of aortic tissue valves due to COVID-19 as the primary reason for the loss. The decline was offset slightly by increased sales of the INSPIRIS RESILIA aortic valve and the KONECT aortic valved conduit, primarily in the U.S., but it was not enough to absorb the deficit created.
Critical Care was only down 2 percent, seeing sales go from $740 million in 2019 to $725 million in 2020. Again, COVID-19 was attributed as the reason.
Regardless of the challenges Edwards may have faced in 2020, the organization still kept a view of future growth opportunities. As such, it celebrated several positive product announcements during the fiscal.
The SAPIEN 3 transcatheter heart valve gained Chinese regulatory approval to treat of patients suffering from severe, symptomatic aortic stenosis (AS) at high risk for or unable to undergo open-heart surgery.
"Now, in China, patients diagnosed with severe AS have the option of a shorter procedure with excellent clinical outcomes, including a more rapid recovery than open-heart surgery," said Prof. Junbo Ge, M.D., academician of the Chinese Academy of Sciences, chairman, Shanghai Institute of Cardiovascular Diseases and director, Department of Cardiology, Zhongshan Hospital, Fudan University.
The approval for high-risk and extreme-risk patients in China was supported by the China SAPIEN 3 study, which complements a highly robust set of clinical outcomes from three randomized controlled PARTNER studies, along with excellent real-world results.
In Europe, the PASCAL Transcatheter Valve Repair System was approved for tricuspid repair. The CE mark was gained specifically for treating patients with tricuspid regurgitation.
The PASCAL system is indicated in Europe for percutaneous tricuspid valve reconstruction through leaflet repair by tissue approximation. The clasps and paddles gently grasp the leaflets to facilitate coaptation, while the spacer is designed to fill the regurgitant orifice area and prevent backflow. The clasps can be operated independently to facilitate optimized leaflet capture and the implant can be elongated to a narrow profile, allowing for safe maneuvering in dense chordal anatomy.
The firm’s KONECT RESILIA aortic valved conduit, the first ready-to-implant solution for bio-Bentall procedures—a complex surgery that involves replacement of a patient's aortic valve, aortic root, and the ascending aorta—gained FDA approval in July. The device’s RESILIA tissue incorporates integrity-preservation technology that may help improve valve durability. The RESILIA tissue technology also allows devices to be stored under dry packaging conditions.
Health Canada approved the expanded use of Edwards’ SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves for the transfemoral treatment of patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open-heart surgery. Edwards said the SAPIEN 3 valves are the first transcatheter aortic valve implantation (TAVI) systems to gain this indication in Canada.