Edwards Lifesciences Corp., the highest valued publicly traded company based in Orange County, expects to leave behind the worst effects of the pandemic in 2021.
The Irvine-based heart valve maker (NYSE: EW) last month projected 2021 global sales of $4.9 billion to $5.3 billion, reflecting underlying growth in the mid-teens, at its annual investor conference.
The company highlighted an urgent need to treat its largest patient population—transcatheter aortic valve replacement patients—and a continued focus on innovation and leadership in therapies for structural heart diseases.
“When you go first, you have the opportunity to learn faster than others,” Chief Executive Mike Mussallem said in his opening remarks at Edwards’ main campus, where expansion plans are underway.
“Simply put, you are a key contributor to shaping the way value gets created.”
Edwards continued to make significant investments in research and clinical activities last year, matching its pace in the year prior, despite expectations of flat global sales in 2020.
“History tells us that organizations that invest in innovation and employees during a crisis outperform their peers during the recovery,” Chief Financial Officer Scott Ullem said.
The company added about 1,000 employees to the organization since March, bringing its total headcount to about 4,700 in Orange County and 15,000 worldwide.
TAVR Spotlight
Edwards is projected to generate $5.09 billion in 2021 global sales, according to consensus analyst estimates.
Analysts appeared optimistic of Edwards’ recovery, given the nature of its transcatheter aortic valve replacement, or TAVR, unit that accounts for about 65% of its global sales.
“We continue to believe there is significant upside potential to this 2021 guidance—as TAVR remains one of the procedure types that is least elective and fastest to recover, regardless of how COVID dynamics unfold from here,” an SVB Leerink analyst report said.
A study in New York City showed one-third of patients awaiting an aortic valve replacement ended up undergoing urgent TAVR surgery or died within the first three months that elective procedures were halted, Edwards said during its conference.
Edwards continues to expect the global TAVR market to grow to $7 billion by 2024.
Bold Innovations
Edwards invested $565 million, or about 18%, of its net sales in research and development for the nine months ended Sept. 30.
By comparison, heart valve competitor Medtronic PLC (NYSE: MDT) spent $1.3 billion, or about 9%, of sales on R&D in the first half of its fiscal 2021, according to the Minneapolis-based company’s latest earnings report.
Edwards said it continues to produce data that enhances the safety profile of its devices for low-risk and younger, more active patients across its sales units.
It also said last month the first patient was treated in its pivotal trial for its minimally-invasive Harpoon Beating Heart mitral valve system in the U.S. The device allows surgeons to forgo open-heart surgery, the company said.
Edwards also launched 10 clinical trials for its mitral and tricuspid therapies in 2020; sales in the company’s smallest unit are estimated to double to $80 million in 2021.
The unit is expected to “fuel sustainable growth in the future as the company unlocks the market share,” according to SVB Leerink analysts.
The mitral and tricuspid therapies market could grow to $3 billion by 2025, the company said.
