Wall Street expressed brief unhappiness with projections made at today’s Edwards Lifesciences (NYSE:EW) annual investor conference in New York, but shares had recovered partially by the close of trading.
The Irvine, Calif.-based heart valve replacement pioneer projected adjusted EPS of $6.05 to $6.30 on global sales of $4.5 billion to $5 billion for 2020. Edwards execs also projected 2020 transcatheter aortic valve replacement (TAVR) sales of $2.9 billion to $3.2 billion and the global market for transcatheter valve therapy to top $10 billion by 2024.
Edwards looks to remain among the top 10 medtech companies in R&D investments in 2020. The company said it plans to dedicate 17% to 18% of 2020 revenue to research and development.
Edwards reaffirmed financial guidance for the rest of this year — adjusted EPS of $5.50 to $5.65 and sales between $4.0 billion and $4.3 billion. Shares in EDW fell 3.6% to $238.60 at market open, but had recovering to $242.96 at the close of trading.
The company expects the TAVR market will be fueled by broader indications, greater disease and therapy awareness and advances in the technology. Additional highlights and expected milestones include:
- TAVR growth driven by strong PARTNER 3 trial evidence that led to the recent FDA indication expansion for the company’s Sapien 3 and Sapien 3 Ultra systems.
- The Sapien 3 valve or system recently received expanded low-risk approval in Europe.
- Sapien] 3 Ultra valve will account for most of the company’s TAVR sales in the U.S. and Europe in 2020.
- Completion of patient enrollment in Sapien 3 pulmonic valve or system with Alterra system pivotal trial.
- Enrollment in the EARLY TAVR study of severe aortic stenosis patients before they develop symptoms expected to be complete in 2021.
Edwards also said it expects the global market for transcatheter mitral and tricuspid therapies (TMTT) to reach about $3 billion by 2024, followed by a significantly larger longer-term opportunity. The company also highlighted:
- Continuing the European launch of the Pascal repair system for mitral patients.
- Fully enrolling the Pascal CLASP IID pivotal trial by year-end 2020.
- Continue enrolling the Pascal CLASP IIF and CLASP IITR pivotal trials.
- Enrolling the Sapien M3, the first transseptal mitral valve replacement pivotal trial.
- Begin an early feasibility study for the Evoque tricuspid valve replacement system.
In the surgical structural heart sector, Edwards anticipates landing regulatory approval in Europe for the Harpoon echo-guided beating-heart system by the end of this year. In 2020, Edwards expects to launch the Konect Resilia system, including the first ready-to-implant tissue valve conduit, as well as the Sutrafix automated fastening system later in the year.
On the critical care front, the company said it is augmenting the HemoSphere patient monitoring platform and anticipates launching the ClearSight system on HemoSphere in 2020.
“In 2019, our therapies benefitted more patients than ever before, exceeding our expectations, and we believe 2020 will be another strong year for Edwards Lifesciences,” Edwards chairman & CEO Michael Mussallem said in a prepared statement. “Our global growth is being driven by innovative therapies that are intended to address the long-term structural heart opportunity, and continued advancement in each of our market-leading product lines. “In 2020, we are projecting another year of double-digit top-line and bottom-line growth while we continue to aggressively pursue breakthrough therapies for millions of patients suffering from structural heart diseases. During the year, we look forward to a number of significant milestones, including new product launches, and progress on multiple pivotal clinical trials and early feasibility studies.”