Edwards Lifesciences (NYSE:EW) reported fourth-quarter and full-year 2025 results that management characterized as strong, driven by continued momentum in transcatheter aortic valve replacement (TAVR) and rapid growth in transcatheter mitral and tricuspid therapies (TMTT). The company said fourth-quarter total sales were $1.57 billion, up 11.6% year over year on a constant-currency basis, and full-year 2025 sales grew 10.7%.
CEO Bernard Zovighian attributed performance to Edwards’ strategy of focusing exclusively on structural heart disease, emphasizing complex patient needs and pursuing “unique opportunities to innovate and lead.” Edwards said it is entering 2026 with “strength and momentum globally” and reiterated long-term expectations of average annual sales growth of 10% beginning in 2027 and beyond, along with operating margin expansion on a constant-currency basis.
TAVR: SAPIEN durability evidence and guideline shifts support growth
Company leaders pointed to multiple clinical and market catalysts driving “renewed focus” on the SAPIEN platform, including seven-year PARTNER 3 and 10-year PARTNER 2 data presented at TCT, as well as the “practice-changing” EARLY TAVR trial. Zovighian said these data reinforced physician and patient confidence in durability and performance and created “lasting impact” on global expansion of SAPIEN.
During Q&A, global TAVR leader Dan Lippis said the gap between high-single-digit procedure growth and Edwards’ 10.6% sales growth reflected both share gains and pricing, noting that the Boston Scientific exit in Europe contributed “a big chunk” of share movement. Lippis also cited increased penetration of SAPIEN 3 Ultra RESILIA as a contributor on the pricing side and said physicians have provided positive feedback on the platform.
In the U.S., management described “intentional and urgent treatment” of severe aortic stenosis patients, supported by growing evidence and increased adoption of SAPIEN 3 Ultra RESILIA. Lippis said that while the EARLY TAVR trial studied asymptomatic patients, Edwards is seeing the study’s biggest near-term impact in symptomatic patients by increasing urgency, referrals, and evaluation. He added that claims data do not show “asymptomatic patients coming in waves,” which he attributed to the current national coverage determination (NCD) not covering asymptomatic indications.
Edwards also highlighted guideline developments in Europe. Lippis said European guideline updates reduced the age recommendation for TAVR from 75 to 70 and shifted the clinical approach away from “watchful waiting” toward proactive disease management “regardless of symptom or heart function.” He cautioned the impact is not a “light switch,” but described it as a durable, multi-layer catalyst over time.
TMTT surpasses $1 billion in 2025 as new products roll out
Edwards’ TMTT product group grew more than 40% in the fourth quarter to $156 million, and the company said full-year TMTT sales exceeded $1 billion. Management attributed growth to continued adoption of PASCAL and EVOQUE and to portfolio expansion.
The company highlighted several milestones and upcoming launches:
- FDA approval and early U.S. launch of SAPIEN M3, which management described as the first transcatheter mitral replacement option for patients suffering from mitral disease.
- Ongoing scaling of EVOQUE with expanding centers and physician training, with a focus on outcomes.
- Planned introduction of next-generation PASCAL in Q4 2026.
- Expected introduction of PASCAL for U.S. tricuspid patients in Q4 2026.
On the call, Daveen Chopra, who leads TMTT, Surgical, and IHFM responsibilities, said the SAPIEN M3 launch is progressing in line with expectations, beginning with sites that participated in the ENCIRCLE pivotal trial. Chopra said physician interest is growing and emphasized procedural success and patient outcomes, noting the therapy addresses a patient subset with limited transcatheter edge-to-edge repair (TEER) or surgical options.
Edwards reaffirmed its expectation for 2026 TMTT sales of $740 million to $780 million and reiterated its longer-term goal of reaching $2 billion in TMTT revenue by 2030.
Surgical grows modestly; LAAC introduction planned
Fourth-quarter surgical sales were $254 million, up 2% year over year. Zovighian said growth was impacted by end-of-year distributor inventory adjustments in one country; during Q&A, management clarified the adjustment occurred in China and described it as a one-time event tied to channel inventory management. Full-year surgical sales grew 4.3% and exceeded $1 billion for the first time.
Edwards said it expects mid-single-digit surgical sales growth in 2026, driven by continued adoption of RESILIA-based products including INSPIRIS, KONECT, and MITRIS. The company also highlighted one-year MOMENTIS study results for the MITRIS system presented at the STS meeting, including 100% freedom from structural valve deterioration (SVD), stable hemodynamic performance, and safety outcomes.
In addition, Edwards discussed plans to enter left atrial appendage closure (LAAC) as a new surgical therapeutic area. Zovighian and Chopra said the company views LAAC as complementary to certain valvular procedures and expects a “measured commercial rollout,” with a preliminary introduction of new surgical LAAC technology later in 2026.
Margins and spending: higher SG&A weighed on Q4 EPS; 2026 guidance reiterated
CFO Scott Ullem said adjusted earnings per share in the fourth quarter were $0.58, which he described as lower than expected due to higher spending on patient access initiatives and a higher-than-expected tax rate. GAAP EPS was $0.11, reflecting one-time charges related to the JenaValve acquisition that did not close and litigation expenses.
Adjusted gross margin was 78.3% in the quarter, down from 79.0% a year earlier, which Ullem attributed to additional manufacturing expenses tied to expansion of new therapies. SG&A rose to $603 million, or 38% of sales, from 35% a year earlier. Ullem said Edwards increased spending to amplify patient access initiatives, including EARLY TAVR education, investments in field resources, and a multi-year American Heart Association heart valve initiative; he noted some spending had been delayed from earlier quarters.
Looking ahead, Edwards said it has “increased confidence” in meeting its 2026 guidance of 8% to 10% sales growth and EPS of $2.90 to $3.05. The company projected first-quarter 2026 sales of $1.55 billion to $1.63 billion and adjusted EPS of $0.70 to $0.76. Ullem said Edwards expects higher growth rates in the first half of 2026 due to unusual summer seasonality that benefited 2025, while Lippis said tougher year-over-year comparisons are expected in the second half.
On capital allocation, Ullem said Edwards’ priorities remain investing in growth (including production capacity), pursuing external investments that are typically smaller and focused on structural heart, and returning capital through share repurchases. He said the company repurchased about $40 million of stock in the fourth quarter, bringing 2025 repurchases to just under $900 million, and noted approximately $2 billion remains under the authorization.
Management also discussed the CMS process to reconsider the TAVR NCD. Edwards said the process was reopened late in 2025, with the initial public comment period closing Jan. 14. Lippis said the company expects an initial draft around June and a final determination potentially in the fourth quarter, adding that the impact on 2026 is expected to be negligible but could become more relevant in 2027 and beyond.
About Edwards Lifesciences (NYSE:EW)
Edwards Lifesciences is a medical technology company focused on products and therapies for structural heart disease and critical care monitoring. The company designs, develops and manufactures prosthetic heart valves and related delivery systems used in both surgical and minimally invasive (transcatheter) procedures. Its portfolio addresses a range of valvular conditions, with an emphasis on technologies that enable transcatheter aortic valve replacement (TAVR) as an alternative to open-heart surgery.
In addition to transcatheter heart valves—including the widely recognized SAPIEN family—Edwards offers surgical tissue valves and ancillary devices used by cardiac surgeons, interventional cardiologists and hospital teams.
