Earnings summaries and quarterly performance for Edwards Lifesciences.
Executive leadership at Edwards Lifesciences.
Bernard Zovighian
Chief Executive Officer
Annette Brüls
Corporate Vice President, EMEACLA
Daniel Lippis
Corporate Vice President, Transcatheter Aortic Valve Replacement
Daveen Chopra
Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies
Donald Bobo Jr
Corporate Vice President, Strategy & Corporate Development
Scott Ullem
Chief Financial Officer
Wayne Markowitz
Senior Vice President, Surgical Structural Heart
Board of directors at Edwards Lifesciences.
Research analysts who have asked questions during Edwards Lifesciences earnings calls.
David Roman
Goldman Sachs Group Inc.
5 questions for EW
Robert Marcus
JPMorgan Chase & Co.
5 questions for EW
Travis Steed
Bank of America
5 questions for EW
Vijay Kumar
Evercore ISI
5 questions for EW
Joanne Wuensch
Citigroup Inc.
3 questions for EW
Larry Biegelsen
Wells Fargo & Company
3 questions for EW
Matthew Taylor
Jefferies
3 questions for EW
Anthony Petrone
Mizuho Group
2 questions for EW
Chris Pasquale
Nephron Research LLC
2 questions for EW
Lawrence Biegelsen
Wells Fargo
2 questions for EW
Matthew Miksic
Barclays PLC
2 questions for EW
Matt Miksic
Barclays Investment Bank
2 questions for EW
Matt Taylor
Jefferies & Company Inc.
2 questions for EW
Patrick Wood
Morgan Stanley
2 questions for EW
Pito Chickering
Deutsche Bank
2 questions for EW
Adam Maeder
Piper Sandler Companies
1 question for EW
Christopher Pasquale
Nephron Research
1 question for EW
Danielle Antalffy
UBS Group AG
1 question for EW
Frederick Wise
Stifel
1 question for EW
Recent press releases and 8-K filings for EW.
- Core structural heart focus: CEO Bernard Zovighian detailed ongoing investment in TAVR (SAPIEN), TMTT (PASCAL, EVOQUE, SAPIEN M3), and surgical (RESILIA) platforms, while expanding into unaddressed segments—asymptomatic AS, mitral, tricuspid disease, and AR.
- 2026 financial guidance: expects 8–10% sales growth, ~15% EPS growth, and 150 bps margin expansion, driven by diversified growth beyond TAVR into TMTT and surgical.
- Key catalysts: highlighted 2025 practice-changing data (EARLY TAVR, seven-year PARTNER 3), upcoming MODERATE trial, U.S. approval of SAPIEN M3, CMS TAVR NCD reopening, and next-gen launches across core platforms.
- AR strategy unchanged: despite JenaValve acquisition being blocked, Edwards remains committed to pioneering aortic regurgitation therapies via its JC Medical pivotal program.
- Edwards plans to expand its structural heart portfolio across TAVR, TMTT and surgical platforms, while pioneering first-of-its-kind therapies for asymptomatic AS, mitral, tricuspid and aortic regurgitation patients.
- For 2026, the company targets 8-10% sales growth, ~15% EPS growth and 150 bps of margin expansion, underpinned by continued investment (>$1 billion in R&D in 2025).
- TMTT is expected to reach $2 billion in revenue by 2030, with TAVR growing mid- to high-single-digit and surgical mid-single-digit; emerging structural heart failure therapies will further drive long-term growth.
- Recent updates include CMS reopening the U.S. TAVR coverage determination to improve patient access, U.S. approval of SAPIEN M3 for mitral replacement, and the blocking of the JenaValve acquisition.
- In 2025, Edwards delivered two practice-changing trials (EARLY TAVR and 7-year durability) and launched two first-of-kind mitral/tricuspid valves, investing > $1 billion in R&D.
- Regulatory updates include CMS reopening the U.S. NCD for TAVR in December 2025 to streamline access, U.S. approval of SAPIEN M3 for mitral disease, and the blocked acquisition of JenaValve with no impact to 2026 guidance.
- For 2026, Edwards targets 8–10% sales growth, ~15% EPS growth at midpoint (including a $0.10 EPS benefit from the JenaValve deal not closing), and 150 bp margin expansion.
- Longer term, Edwards expects mid- to high-single-digit CAGR in TAVR, $2 billion in TMTT revenue by 2030, mid-single-digit surgical growth, and evolving contributions from structural heart failure and AR therapies, driving ~10% average annual company growth.
- FTC injunction blocks Edwards’ proposed acquisition of JenaValve Technology, so the deal will not proceed.
- Edwards disagrees with the decision and reaffirms commitment to aortic regurgitation therapy, advancing the SOJOURN valve and JOURNEY pivotal trial.
- Raises full-year 2026 adjusted EPS guidance to $2.90–$3.05 from $2.80–$2.95; further updates to be provided at the Q4 earnings call in February.
- A U.S. District Court granted an injunction blocking Edwards’s planned acquisition of JenaValve, prompting Edwards to abandon the deal.
- The FTC argued the merger would reduce competition in TAVR systems for aortic regurgitation, noting Edwards and JenaValve are the only firms in U.S. clinical trials.
- Edwards raised its full-year 2026 adjusted EPS guidance to $2.90–$3.05 (from $2.80–$2.95), close to the $2.87 analyst consensus.
- The ruling underscores heightened regulatory scrutiny of consolidation in the medical device industry.
- Edwards Lifesciences (NYSE: EW) secured FDA approval for its SAPIEN M3 mitral valve replacement system, the first transseptal transcatheter therapy for mitral regurgitation in the U.S.
- The SAPIEN M3 TMVR system is indicated for treating symptomatic moderate-to-severe or severe MR in patients deemed unsuitable for surgery
- FDA approves the SAPIEN M3 transcatheter mitral valve replacement (TMVR) system, making it the first transseptal transcatheter therapy for symptomatic moderate-to-severe or severe mitral regurgitation in patients unsuitable for surgery or transcatheter edge-to-edge repair.
- One-year data from the ENCIRCLE pivotal trial (299 patients) demonstrated 95.7% MR elimination (≤0/1 +) and meaningful improvements in symptoms and quality-of-life.
- The system employs a fully percutaneous, 29F transseptal steerable guide sheath via the femoral vein for dock and valve delivery.
- SAPIEN M3 received CE Mark in April 2025, becoming the world’s first approved transfemoral TMVR system and broadening Edwards’s transcatheter mitral and tricuspid therapy portfolio.
- The global transcatheter heart valve replacement market is projected to grow from USD 6.40 billion in 2025 to USD 19.98 billion by 2033, at a CAGR of 15.32% during 2026–2033.
- The U.S. market is estimated at USD 2.65 billion in 2025 and is expected to reach USD 8.24 billion by 2033, growing at a 15.24% CAGR driven by advanced infrastructure and regulatory approvals.
- Growth drivers include an aging population, increasing adoption of minimally invasive procedures, favorable reimbursement policies, and rapid technological advancements in valve design.
- Edwards expects 8%–10% total sales growth in 2025, with TAVR up 5%–7%, TMTT growing 50%–60% to over $500 million, and EPS of $2.40–$2.50.
- For 2026 and beyond, the company targets ~10% average annual revenue growth and double-digit EPS growth, driven by catalysts such as early TAVR approval in mid-2025, the PROGRESS trial readout in 2026, and the U.S. launch of SAPIEN M3 in early 2026; TMTT is aimed at $2 billion by 2030.
- The strategic focus is on structural heart with three 2025 growth drivers (TAVR, mitral, tricuspid) and two emerging areas (aortic regurgitation and heart failure). The pipeline features Gen 5 SAPIEN Ultra, EVOQUE and SAPIEN M3, supported by $1 billion internal and $1.6 billion external R&D investments, over 10,000 patents, and ongoing category leadership.
- Edwards Lifesciences projects 2026 sales of $6.4 – $6.8 billion (8 – 10% growth) and adjusted EPS of $2.80 – $2.95 (~11% growth at midpoint).
- TAVR business expected to grow 6 – 8% in 2026, TMTT sales of $740 – $780 million (targeting $2 billion by 2030), and surgical segment mid-single-digit growth.
- Ongoing R&D investments to drive innovation, targeting ~17% of sales in 2026, with 40% allocated to scientific evidence and 35% to new product development.
- Strong capital deployment with ~$280 million CAPEX in 2026 , a remaining $2 billion share repurchase authorization, and opportunistic buybacks driving shares outstanding to 580 – 585 million.
Quarterly earnings call transcripts for Edwards Lifesciences.
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