Irvine, Calif.-based Edwards is projecting 2021 TAVR sales to represent growth of between 15% and 20% as well as growth in the mid-teens for global sales, the company shared during its investor day presentation. Additionally, Edwards projected adjusted earnings per share for 2021 for between $2 and $2.20.
The markets responded to Edwards’ strong expectations with a 2.1% jump in EW shares at $86.82 in late-afternoon trading today.
One of the hottest spaces in medtech, TAVR remains Edwards’ major business, with expectations that its global TAVR opportunity will reach more than $7 billion by 2024, with continued growth to follow.
The company noted milestones it has earmarked for 2021, including completing enrollment for the Early TAVR trial for treating severe aortic stenosis patients before symptom development, as well as FDA approval for a moderate aortic stenosis pivotal clinical trial.
Edwards expects approval for low-risk patients in Japan for later next year, as well as U.S. approval for the Sapien 3 pulmonic valve with the Alterra pre-stent system. Additionally, enrollment is expected to begin in a clinical trial for the next-generation Sapien X4.
Edwards also highlighted critical care as a growth space, namely with innovations in hemodynamic monitoring solutions using artificial intelligence, something the company’s GM of critical care, Katie Szyman, told MassDevice was part of Edwards’ patient-focused strategy.
In addition to developing the HemoSphere monitoring platform designed to enhance recovery tools in smart monitoring, Edwards anticipates the launch of its Viewfinder connectivity solution in 2021.
The company found that overall sequential growth is trending positively, while growth is flat when compared to a 20% rise in the fourth quarter of 2019. Edwards believes that, as the COVID-19 pandemic persists, hospitals will improve with treating non-COVID patients who need care for structural heart conditions when compared to the earlier stages of the pandemic.