Edwards Lifesciences (NYSE:EW) today released its strategies for longer-term growth, updated on its technology pipeline and released preliminary financial guidance for the coming fiscal year in its investor day presentation.
Edwards lead with news about its transcatheter aortic valve replacement technologies, saying it expects that TAVR opportunity will reach approximately $7 billion by 2024, and that it estimates its TAVR sales next year will be between $2.4 billion and $2.7 billion.
The Irvine, Calif.-based company said that it plans to continue investing in TAVR research & development and clinical trials and that it wants to “produce additional transformational TAVR technologies.” Edwards added that it expects to receive a low-risk indication for its existing TAVR tech late next year, with a single-arm trial launch planned for next year exploring the use of TAVR in underrepresented and minority populations.
Edwards spoke on its transcatheter mitral and tricuspid therapies, saying it expects the tech to have an estimated opportunity of approximately $3 billion by 2024. The company said it “expects a strong cadence of transformational therapies,” including three TMTT tech devices to be available in Europe next year.
The company said it expects to launch its Konect system, featuring a ready-to-implant tissue valve conduit, some time next year in both the U.S. and Europe, with a release of its Harpoon system in Europe by mid-year 2019. It added that it is hopeful it will begin a phased rollout of its HemoSphere platform early next year in both the U.S. and Europe.
On the financial said, Edwards said that it expects to post sales of between $3.9 billion and $4.3 billion, representing growth of 9% to 12%, and adjusted earnings per share of between $5.05 and $5.30.
“In 2018, we are delivering results and making significant progress on milestones to drive future growth and success. In 2019, we are projecting strong sales growth and financial performance 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 the Partner 3 Trial results, new product launches, and progress on multiple clinical trials and early feasibility studies, advancing innovations to treat mitral and tricuspid valve diseases,” chair & CEO Michael Mussallem said in a press release.
Earlier this week, Edwards said that it won FDA 510(k) clearance for its Hemosphere platform with the Acumen suite of decision-support solutions intended for hemodynamic monitoring.