Release Date: April 23, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Edwards Lifesciences Corp (EW, Financial) reported an 8% increase in total company sales, reaching $1.41 billion in the first quarter of 2025.
- The company raised its 2025 TMTT sales guidance range to $530 million to $550 million, reflecting strong momentum in its transcatheter mitral and tricuspid therapies.
- Edwards Lifesciences Corp (EW) achieved significant milestones, including the approval of Sapien M3 in Europe, the world's first transcatheter mitral valve replacement system.
- The company maintained its full-year total company sales growth guidance of 8% to 10%, demonstrating confidence in its strategic plans.
- Edwards Lifesciences Corp (EW) has a strong balance sheet with approximately $3 billion in cash and cash equivalents, providing financial flexibility for future investments.
Negative Points
- The company faces potential impacts from tariffs and the JenaValve acquisition, which could affect future financial results.
- Edwards Lifesciences Corp (EW) experienced weaker procedure growth and competitive pressure in Japan, impacting sales performance in the region.
- The company anticipates pressure on its operating margin due to the weakening dollar and announced tariffs.
- There is uncertainty regarding the timing of the national coverage decision (NCD) for TAVR, which could impact the expansion of treatment centers.
- The launch of the Sapien M3 mitral valve replacement system in Europe is expected to be gradual, with a focus on creating a new category and achieving excellent patient outcomes.
Q & A Highlights
Q: You're maintaining the EPS guidance despite the tariffs and the JenaValve acquisition. Can you break down the impact of each on 2025?
A: Scott Ullem, CFO: The impact from tariffs is about $0.05 to EPS for 2025. The JenaValve acquisition is estimated to impact EPS by $0.05 to $0.10. Our hedging program helps mute the impact of foreign exchange changes on our EPS.
Q: How do you see the NCD impacting the ramp of EVOQUE?
A: Daveen Chopra, Corporate VP - Surgical Structural Heart: The NCD ensures that both standard Medicare and Medicare Advantage patients have access to EVOQUE. This aligns with our expectations and is built into our guidance for 2025, marking the start of a multiyear growth opportunity.
Q: What are you seeing in the TAVR business regarding referral patterns or physician engagement post the EARLY TAVR presentation?
A: Larry Wood, Corporate VP - TAVR: The data set was strong, but it takes time for physicians to understand the nuances. Biomarkers were not predictive, stressing the need for patient referrals. We expect the indication approval in Q2, which will allow us to amplify our education efforts.
Q: Can you discuss the market segmentation for TMTT and the mix between repair and replacement?
A: Bernard Zovighian, CEO: We offer a toolbox approach with both repair and replacement options. TEER technology alone is insufficient, so we launched EVOQUE and M3. The segmentation is still developing, but having both options allows us to treat a larger group of patients.
Q: How are you addressing TAVR capacity constraints and potential NCD changes?
A: Larry Wood, Corporate VP - TAVR: We believe it's time to reopen the NCD to cover asymptomatic patients and add more hospitals. Acute capacity issues have improved, and we continue to work with hospitals to expand capabilities. Policy changes and investments will be long-term solutions.
Q: How are you offsetting the EPS headwinds from tariffs and JenaValve?
A: Scott Ullem, CFO: We are focusing on prioritizing R&D investments and discretionary spending that won't impact our sales guidance. We are confident in our ability to execute our strategy while offsetting these headwinds.
Q: Can you provide an update on the demand for EVOQUE training and site activations?
A: Daveen Chopra, Corporate VP - Surgical Structural Heart: Demand for EVOQUE training is high, with trial sites booked months in advance. We aim to expand to more TAVR centers over time, similar to the TAVR rollout.
Q: What is your confidence in sustaining mid-single-digit growth in the Surgical segment?
A: Scott Ullem, CFO: Despite challenging comps, we remain confident in mid-single-digit growth for 2025, supported by new product launches like MITRIS in China and potential approvals like KONECT in Europe.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
