US Market News
2月前
Ten-Year Pivotal Data Demonstrate Long-Term Durability of Edwards Lifesciences’ Resilia TissueMay 2, 2026 11:50 AM
Business Wire
Edwards Lifesciences (NYSE: EW) today announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue. The data were presented at the 106th American Association for Thoracic Surgery Annual Meeting.
As evidence increasingly supports treating patients earlier in the valve disease pathway, the need for durable valve solutions continues to grow. The COMMENCE trial provides prospective, 10-year data demonstrating the durability of Edwards’ RESILIA tissue and its role in lifetime management for patients with aortic stenosis. To date, more than 500,000 patients worldwide have been treated with Edwards’ surgical and transcatheter innovations featuring RESILIA tissue.
At 10 years, COMMENCE trial data showed that patients treated with Edwards’ surgical valves featuring RESILIA tissue experienced:
97.9% freedom from structural valve deterioration (SVD)
97.8% freedom from reoperation due to SVD
98.6% freedom from non-structural valve dysfunction (other than PVL)
Sustained hemodynamic performance, including stable gradients and effective orifice area over time
For patients, long-term durability matters because it can reduce the likelihood of repeat procedures over a lifetime, helping preserve quality of life as life expectancy increases.
“These 10-year data from the COMMENCE trial suggest this tissue technology has the potential to change the way we think about durability in biological valves, including in younger patients,” said Lars G. Svensson, MD, PhD, chief of the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and professor of surgery at Cleveland Clinic. “What is striking is the low rate of structural valve deterioration and need for reoperation, even though the trial enrolled younger patients who historically face higher risks of valve deterioration, underscoring the importance of long-term evidence when physicians are making treatment decisions with their patients.”
For nearly 70 years, Edwards has led structural heart innovation, advancing evidence generation that has helped set the standard for evaluating valve performance, durability and treatment options in severe aortic stenosis. The COMMENCE trial builds on the totality of Edwards’ clinical evidence, reinforcing the durability of outcomes supporting its surgical and transcatheter therapies, including large, randomized, FDA-approved studies such as the PARTNER series of trials.
The PARTNER trial series advanced the field with long-term patient outcomes on treatment with SAPIEN TAVR and SAVR, with 10 years of follow-up data. The new COMMENCE trial data build on that foundation with the latest evidence on the long-term durability of RESILIA tissue.
RESILIA tissue was designed to enhance the durability of tissue valves by helping resist calcification, a leading cause of valve failure over time. The technology combines advanced calcium blocking processes with dry storage to support long-term valve performance.
“As patients live longer and expect to remain active, structural heart therapies must be designed with lifetime care in mind,” said Bernard Zovighian, Edwards’ CEO. “The COMMENCE 10-year study is the latest addition to our breadth of long-term data reflecting our commitment to advancing durable valve technologies through continuous evidence development, so Heart Teams and patients can make informed decisions over time.”
The COMMENCE aortic trial is an FDA-approved, pivotal, prospective, multicenter clinical study designed to evaluate the safety and effectiveness of a bioprosthetic valve with RESILIA tissue used in SAVR, with follow-up through 10 years. Safety endpoints were defined according to established guidelines and independently adjudicated.
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Zovighian and statements regarding expected long-term durability and sustained performance, reduction of the likelihood of repeat procedures, therapies helping to preserve quality of life, outcomes of the surgical and transcatheter therapies, expectations for remaining active, and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, PARTNER, RESILIA, and SAPIEN are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260502326120/en/
Media: Maureen Ranney, media@edwards.com
Investors: Gerianne Sarte, investor_relations@edwards.com
Original: Ten-Year Pivotal Data Demonstrate Long-Term Durability of Edwards Lifesciences’ Resilia Tissue
US Market News
2月前
Edwards Lifesciences Reports First Quarter ResultsApril 23, 2026 4:15 PM
Business Wire
Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended March 31, 2026.
Highlights and Outlook
Q1 sales grew 16.7% to $1.65 billion1, constant currency2 sales grew 12.7%
Q1 TAVR sales grew 14.4% to $1.20 billion1; constant currency2 sales grew 11.0%
Q1 TMTT sales of $173 million1,3, driven by repair and replacement therapies
Q1 EPS of $0.661; adjusted2 EPS of $0.781
Raising FY 2026 constant currency2 sales growth guidance to 9% to 11% from 8% to 10%
Raising FY 2026 adjusted2 EPS guidance midpoint; new range of $2.95 to $3.05 from $2.90 to $3.05
Renewed clinical focus on proactive disease management with differentiated SAPIEN TAVR
Completed $500 million Accelerated Share Repurchase
“Building on a year in 2025 marked by solid financial performance and strategic progress, we delivered another strong quarter in Q1, achieving 12.7% sales growth, which reflects the impact and durability of our focused strategy. We remain dedicated to solving large, urgent and complex patient needs and pursuing unique opportunities to innovate and lead in structural heart disease,” said Bernard Zovighian, Edwards’ CEO. “Based on our first quarter performance, we are raising our financial guidance for 2026. We continue to pursue additional meaningful growth opportunities across our portfolio, and our financial strength and strategic clarity give us confidence in the future.”
Transcatheter Aortic Valve Replacement (TAVR)
In the first quarter, the company reported TAVR sales of $1.2 billion, which grew 14.4% compared to the prior year, or 11.0% on a constant currency basis. SAPIEN growth in the U.S. was healthy, and it was even faster outside of the U.S. Edwards’ global competitive position in the first quarter increased slightly year-over-year mainly due to the exit of a competitor in Europe. Average selling prices were stable globally. Based on Edwards’ first quarter TAVR performance, the company is raising its full-year 2026 TAVR sales growth guidance to 7% to 9% from 6% to 8%.
Recent clinical trial results on long-term TAVR performance continue to support patient treatment with SAPIEN TAVR. The company is encouraged by the broader momentum that the EARLY TAVR study data has generated across the clinical community for both symptomatic and asymptomatic patients. There has been a shift toward proactive disease management, with an increased focus on evaluation and intentional referral of patients with severe aortic stenosis earlier in the disease pathway. This evolution in patient management, combined with a large and growing body of long-term SAPIEN outcomes data, reinforces the company’s confidence in the durable, multi-year growth opportunity ahead. Later this year, results of the PROGRESS trial studying patients with moderate AS will be presented at the TCT conference.
In the U.S., the Centers for Medicare & Medicaid Services (CMS) is conducting the process to reconsider the National Coverage Determination (NCD) for TAVR. This decision has the potential to improve timely access to lifesaving TAVR therapy. In Europe, first quarter results demonstrated continued strong commercial execution and sustained physician demand for the SAPIEN platform. Updated guidelines from the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery are reshaping clinical discussions around proactive disease management and reinforcing the role of TAVR for a broader patient population. Outside of Europe, sales growth was strong across multiple geographies, including Japan, driven by procedural growth and adoption of our SAPIEN 3 Ultra RESILIA platform.
Transcatheter Mitral and Tricuspid Therapies (TMTT)
First quarter TMTT sales of $173 million were driven by the company’s unique portfolio of repair and replacement therapies to treat mitral and tricuspid diseases. Globally, mitral and tricuspid procedures grew in the estimated double digits, with Edwards’ sales growing at a higher rate.
In tricuspid, at the recent American College of Cardiology (ACC) scientific session, two-year TRISCEND II data were presented, demonstrating significantly lower all-cause mortality with EVOQUE when accounting for patient crossover. The company continues to increase patient access to transcatheter tricuspid valve replacement and drive further adoption of EVOQUE by expanding into new centers.
Adoption of Edwards’ PASCAL transcatheter edge-to-edge repair (TEER) technology continues to increase, driven by physician enthusiasm for its unique design and differentiated outcomes, and underscored by the significant needs of these patients. The company’s progress on the PASCAL pipeline remains on track, with a next-generation technology expected in Q4 for both mitral and tricuspid patients in the U.S. and Europe. In addition, Edwards expects the launch of PASCAL in the U.S. for tricuspid patients in Q4 of this year, which will expand the population of patients that can benefit from this impactful technology.
The recent FDA approval of SAPIEN M3 expands Edwards’ mitral portfolio in the U.S. The company’s commercial experience, while early, validates the need for this mitral replacement solution for patients who are not well-suited for mitral TEER. Physician feedback on patient outcomes and procedural experience with SAPIEN M3 has been positive.
The strong and increasing utilization of Edwards’ differentiated therapies – EVOQUE, PASCAL and SAPIEN M3 – combined with double-digit mitral and tricuspid procedure volumes globally positions Edwards for continued growth.
Surgical
In Surgical, first quarter global sales of $276 million increased 10.1% compared to the prior year, or 5.9% on a constant currency basis, driven by continued adoption of the company’s RESILIA therapies that offer extended durability. INSPIRIS adoption continues to increase globally. The KONECT aortic valved conduit, which facilitates Bentall procedures for patients in need, recently launched in Europe with strong adoption. With the launch of MITRIS in additional markets around the world, uptake of this technology in surgical mitral valve replacement procedures was strong.
The 10-year data from the company’s COMMENCE trial, studying the long-term durability of its best-in-class RESILIA tissue, will be presented at the upcoming American Association for Thoracic Surgery (AATS) conference. Edwards continues to expect that its surgical tricuspid valve, TRIFORMIS, will launch in the second half of the year. The company’s surgical Left Atrial Appendage Closure, or LAAC, program is on track for preliminary introduction later this year.
Additional Financial Results
For the quarter, gross profit margin was 78.0%, or 78.2% adjusted, compared to 78.7% in the same period last year. The year-over-year change was driven by a weakening dollar as well as additional manufacturing expenses related to the expansion of new therapies. The company is maintaining its full-year 78% to 79% gross margin guidance.
Selling, general and administrative expenses in the first quarter were $522 million, or 31.7% of sales, compared to 33.0% of sales in the prior year. This was in line with the company’s expectations and reflects continued funding of resources Edwards provides to support patient care as well as a higher translation of the company’s OUS expense base from the weakening dollar. Research and Development (R&D) expenses in the first quarter were $263 million, or 16.0% of sales, compared to 18.0% in the prior year. This decrease in R&D as a percentage of sales and increase in total expense reflects Edwards’ strong top-line growth as well as strategic prioritization of investments in its expanding structural heart portfolio. The company continues to expect R&D expense as a percentage of sales to be approximately 17% in 2026.
Operating profit margin in the first quarter of 29.0%, or 31.4% adjusted, was in line with the company’s expectation for the quarter. Adjusted EPS was $0.78 and benefited from solid operational performance and planned phasing of strategic investments during the course of the year. In 2026, Edwards expects full-year operating profit margin to be at the high end of the company’s original 28% to 29% guidance range, resulting in approximately 150 basis points of constant currency operating margin expansion for the full year.
Cash and cash equivalents were approximately $2.4 billion as of March 31, 2026. Total debt was approximately $600 million.
Also during the quarter, the company entered into an Accelerated Share Repurchase agreement to buy back $500 million in shares. Edwards has approximately $1.5 billion remaining under its share repurchase authorization.
Outlook
Due to stronger-than-expected first quarter results, Edwards is raising its full-year 2026 sales growth rate guidance to 9% to 11% from 8% to 10% and TAVR product group sales growth rate guidance to 7% to 9% from 6% to 8%. Edwards now expects total company sales of $6.5 to $6.9 billion, and TAVR sales of $4.7 to $5.0 billion at current exchange rates. The company continues to expect $740 to $780 million in TMTT sales and mid-single-digit sales growth in Surgical in 2026. In addition, Edwards is raising the midpoint of its full-year adjusted EPS guidance with a new range of $2.95 to $3.05 from $2.90 to $3.05. For the second quarter of 2026, the company projects total sales to be between $1.66 and $1.74 billion and adjusted EPS of $0.70 to $0.76.
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
Conference Call and Webcast Information
The company will be hosting a conference call today at 2:00 p.m. PT to discuss its first quarter results. To participate in the conference call, dial (877) 704-2848 or (201) 389-0893. The call will also be available live and archived on the “Investor Relations” section of the Edwards website at ir.edwards.com or www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as “may,” “will,” “should,” “anticipate,” “believe,” “plan,” “project,” “estimate,” “forecast,” “potential,” “predict,” “early clinician feedback,” “expect,” “intend,” “guidance,” “outlook,” “optimistic,” “aspire,” “confident” or other forms of these words or similar expressions and include, but are not limited to, statements made by Mr. Zovighian; statements regarding clinical trial results and the momentum generated by results; evidence resonating with clinicians; competitive trends; CMS’ reconsideration of the TAVR NCD; adoption of our technologies; utilization of our therapies; quality of clinical and patient outcomes and impacts; technologies delivering strong and positive growth; expectations for R&D spending; expanding opportunity to meet patient needs; regulatory approvals, and the information in the Additional Financial Results and Outlook sections. No inferences or assumptions should be made from statements of past performance, efforts, or results which may not be indicative of future performance or results. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain, difficult to predict, and may be outside of the company’s control. The company's forward-looking statements speak only as of the date on which they are made and the company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the company does update or correct one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include risk and uncertainties associated with the risks detailed in the company's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and its other filings with the SEC. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, EARLY TAVR, EVOQUE, INSPIRIS, KONECT, MITRIS, PARTNER, PARTNER II, PARTNER 3, PASCAL, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, SAPIEN M3, TRISCEND, and TRISCEND II are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
_____________
[1]
Reported sales and diluted EPS are from continuing operations.
[2]
The company uses the terms “adjusted” and “constant currency” when referring to non-GAAP sales from continuing operations and sales growth information, respectively, which excludes currency rate fluctuations and newly acquired products. Adjusted earnings per share from continuing operations is a non-GAAP item computed on a diluted basis and in this press release also excludes certain litigation expenses, amortization of intangible assets, a gain on remeasurement of previously held interest upon acquisition, loss on impairment, and separation costs. See “Non-GAAP Financial Information” and reconciliation tables below.
[3]
Represents “adjusted” revenues excluding $2.0 million of revenues related to Implantable Heart Failure Management. Refer to "Reconciliation of Sales by Product Group and Region" table.
EDWARDS LIFESCIENCES CORPORATION
Unaudited Consolidated Statements of Operations
(in millions, except per share data)
Three Months Ended
March 31,
2026
2025
Net sales
$
1,648.6
$
1,412.7
Cost of sales
362.6
301.6
Gross profit
1,286.0
1,111.1
Selling, general, and administrative expenses
522.2
465.7
Research and development expenses
263.3
254.6
Certain litigation expenses
37.1
10.9
Separation costs
—
4.2
Other operating income
(14.2
)
(19.1
)
Operating income, net
477.6
394.8
Interest income, net
(33.5
)
(36.5
)
Loss on impairment
123.6
—
Other non-operating income, net
(71.5
)
(2.6
)
Income from continuing operations before provision for income taxes
459.0
433.9
Provision for income taxes
78.3
70.3
Net income from continuing operations
$
380.7
$
363.6
Loss from discontinued operations, net of tax
—
(7.2
)
Net income
380.7
356.4
Net loss attributable to noncontrolling interest
—
(1.6
)
Net income attributable to Edwards Lifesciences Corporation
$
380.7
$
358.0
Earnings per share:
Basic:
Continuing operations
$
0.66
$
0.62
Discontinued operations
$
—
$
(0.01
)
Basic earnings per share
$
0.66
$
0.61
Diluted:
Continuing operations
$
0.66
$
0.62
Discontinued operations
$
—
$
(0.01
)
Diluted earnings per share
$
0.66
$
0.61
Weighted-average common shares outstanding:
Basic
579.2
586.9
Diluted
580.7
587.8
Operating statistics from continuing operations
As a percentage of net sales:
Gross profit
78.0
%
78.7
%
Selling, general, and administrative expenses
31.7
%
33.0
%
Research and development expenses
16.0
%
18.0
%
Operating income
29.0
%
27.9
%
Income before provision for income taxes
27.8
%
30.7
%
Net income from continuing operations
23.1
%
25.7
%
Effective tax rate
17.1
%
16.2
%
_____________
Note: Numbers may not calculate due to rounding.
EDWARDS LIFESCIENCES CORPORATION
Non-GAAP Financial Information
To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles (“GAAP”), the Company uses non-GAAP historical financial measures. Management makes adjustments to the GAAP measures for items (both charges and gains) that (a) do not reflect the core operational activities of the Company, (b) are commonly adjusted within the Company’s industry to enhance comparability of the Company’s financial results with those of its peer group, or (c) are inconsistent in amount or frequency between periods (albeit such items are monitored and controlled with equal diligence relative to core operations). The Company uses the terms “adjusted” and “constant currency” when referring to non-GAAP sales from continuing operations and sales growth information, respectively, which excludes currency exchange rate fluctuations and newly acquired products. The Company uses the term “adjusted” to also exclude certain litigation expenses, amortization of intangible assets, a gain on remeasurement of previously held interest upon acquisition, loss on impairment, and separation costs.
Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results, and evaluating current performance. These non-GAAP financial measures are used in addition to, and in conjunction with, results presented in accordance with GAAP and reflect an additional way of viewing aspects of the Company's operations by investors that, when viewed with its GAAP results, provide a more complete understanding of factors and trends affecting the Company's business and facilitate comparability to historical periods.
Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. A reconciliation of non-GAAP historical financial measures to the most comparable GAAP measure is provided in the tables below.
Fluctuations in currency exchange rates impact the comparative results and sales growth rates of the Company's underlying business. Management believes that excluding the impact of currency exchange rate fluctuations from its sales growth provides investors a more useful comparison to historical financial results. The impact of the fluctuations has been detailed in the “Reconciliation of Sales by Product Group and Region.”
Guidance for sales and sales growth rates is provided on a “constant currency basis,” and projections for diluted earnings per share, net income and growth, gross profit margin, and taxes are also provided on a non-GAAP basis, as adjusted, for the items identified above due to the inherent difficulty in forecasting such items without unreasonable efforts. The Company is not able to provide a reconciliation of the non-GAAP guidance to comparable GAAP measures due to the unknown effect, timing, and potential significance of special charges or gains, and management's inability to forecast charges associated with future transactions and initiatives.
The items described below are adjustments to the GAAP financial results in the reconciliations that follow:
Certain Litigation Expenses - The Company incurred certain litigation expenses of $37.1 million and $10.9 million in the first quarter of 2026 and 2025, respectively. Such expenses relate to intellectual property litigation, settlements, contingencies, and external legal costs.
Amortization of Intangible Assets - The Company recorded amortization expense related to developed technology and patents in the amount of $3.3 million and $1.4 million in the first quarter of 2026 and 2025, respectively.
Separation Costs - The Company recorded expenses of $4.2 million in the first quarter of 2025, related to consulting, legal, tax, and other professional advisory services related to the sale of Critical Care.
Gain on Remeasurement of Previously Held Interest Upon Acquisition - The Company recorded a $65.2 million gain in the first quarter of 2026 to remeasure its previously held interest upon acquisition of an investee.
Loss on Impairment - The Company recorded loss on impairment of $123.6 million in the first quarter of 2026 ($99.0 million net of tax adjustment), due to the carrying amount of one of its VIE investments not being recoverable.
Provision for Income Taxes - The income tax impacts of the expenses and gains discussed above are based upon the items' forecasted effect upon the Company's full-year effective tax rate. Adjustments to forecasted items unrelated to the expenses and gains above, as well as impacts related to interim reporting, will have an effect on the income tax impact of these items in subsequent periods.
EDWARDS LIFESCIENCES CORPORATION
Unaudited Reconciliation of GAAP to Non-GAAP Financial Information
(in millions, except per share and percentage data)
Three Months Ended March 31, 2026
Net Sales
Gross
Profit
Margin
Operating
Income,
net
Operating
Profit
Margin
Loss on
Impairment
Other
Non-
operating
Income
Net Income
Diluted
EPS
Effective
Tax Rate
GAAP - Continuing Operations
$
1,648.6
78.0
%
$
477.6
29.0
%
$
(123.6
)
$
71.5
$
380.7
$
0.66
17.1
%
Non-GAAP adjustments: (A) (B)
Certain litigation expenses
—
—
37.1
2.2
—
—
29.0
0.05
0.2
Amortization of intangible assets
—
0.2
3.3
0.2
—
—
2.6
—
—
Gain on remeasurement of previously held interest upon acquisition
—
—
—
—
—
(65.2
)
(56.1
)
(0.10
)
0.5
Loss on impairment
—
—
—
—
123.6
—
99.0
0.17
0.6
Adjusted
$
1,648.6
78.2
%
$
518.0
31.4
%
$
—
$
6.3
$
455.2
$
0.78
18.4
%
Three Months Ended March 31, 2025
Net Sales
Gross
Profit
Margin
Operating
Income,
net
Operating
Profit
Margin
Loss on
Impairment
Other
Non-
operating
Income
Net Income
Diluted
EPS
Effective
Tax Rate
GAAP - Continuing Operations
$
1,412.7
78.7
%
$
394.8
27.9
%
$
—
$
2.6
$
363.6
$
0.62
16.2
%
Net loss attributable to noncontrolling interests
—
—
—
—
—
—
1.6
—
—
Total attributable to Edwards Lifesciences Corporation
1,412.7
78.7
%
394.8
27.9
%
—
2.6
365.2
0.62
16.2
%
Non-GAAP adjustments: (A) (B)
Certain litigation expenses
—
—
10.9
0.8
—
—
8.8
0.01
0.1
Amortization of intangible assets
—
—
1.4
0.1
—
—
1.2
—
—
Separation costs
—
—
4.2
0.3
—
—
3.4
0.01
—
Adjusted
$
1,412.7
78.7
%
$
411.3
29.1
%
$
—
$
2.6
$
378.6
$
0.64
16.3
%
_____________
(A)
See description of non-GAAP adjustments under “Non-GAAP Financial Information.”
(B)
The tax effect on non-GAAP adjustments is calculated based upon the impact of the relevant tax jurisdictions’ statutory tax rates on the Company’s estimated annual effective tax rate, or discrete rate in the quarter, as applicable. The impact on the effective tax rate is reflected on each individual non-GAAP adjustment line item.
RECONCILIATION OF SALES BY PRODUCT GROUP AND REGION
2025 Adjusted
Sales by Product Group (QTD) - Continuing Operations
1Q 2026
1Q 2025
Change
GAAP
Growth
Rate*
FX
Impact
1Q 2025
Adjusted
Sales
Constant
Currency
Growth
Rate *
Transcatheter Aortic Valve Replacement
$
1,197.3
$
1,046.6
$
150.7
14.4
%
$
32.0
$
1,078.6
11.0
%
Transcatheter Mitral and Tricuspid Therapies (A)
175.1
115.2
59.9
51.9
%
7.4
122.6
42.8
%
Surgical (B)
276.2
250.9
25.3
10.1
%
9.8
260.7
5.9
%
Total
$
1,648.6
$
1,412.7
$
235.9
16.7
%
$
49.2
$
1,461.9
12.7
%
2025 Adjusted
Sales by Region (QTD) - Continuing Operations
1Q 2026
1Q 2025
Change
GAAP
Growth
Rate*
FX
Impact
1Q 2025
Adjusted
Sales
Constant
Currency
Growth
Rate *
United States
$
937.6
$
838.9
$
98.7
11.8
%
$
—
$
838.9
11.8
%
Europe
442.6
341.8
100.8
29.5
%
42.9
384.7
15.1
%
Japan
90.6
81.8
8.8
10.8
%
(0.9
)
80.9
12.0
%
Rest of World
177.8
150.2
27.6
18.4
%
7.2
157.4
13.0
%
Outside of the United States
711.0
573.8
137.2
23.9
%
49.2
623.0
14.1
%
Total
$
1,648.6
$
1,412.7
$
235.9
16.7
%
$
49.2
$
1,461.9
12.7
%
_____________
(A)
Includes $2.0 million and $0.4 million of revenues related to Implantable Heart Failure Management for the first quarter of 2026 and 2025, respectively.
(B)
For the first quarter 2026, $3.0 million of revenues related to a transitional service agreement from the 2025 sale of our non-core product group were included in Surgical sales.
* Numbers may not calculate due to rounding.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260423207342/en/
Media: Amy Meshulam, media@edwards.com
Investors: Gerianne Sarte, investor_relations@edwards.com
Original: Edwards Lifesciences Reports First Quarter Results
US Market News
4月前
Edwards Lifesciences Advances Structural Heart Care Through Innovation and PurposeFebruary 26, 2026 9:15 AM
Business Wire
At the close of Heart Month, Edwards Lifesciences (NYSE: EW) underscored its leadership in structural heart innovation, advancing care through deep expertise and strong partnerships so people with structural heart disease can live longer, healthier lives. As part of this commitment, Edwards announced the impact and renewed vision for Every Heartbeat Matters, its signature global health initiative, to help 2 million more patients facing barriers worldwide access lifesaving structural heart treatment by the end of 2030.
“For nearly 70 years, Edwards has led with a strong focus on improving the lives of patients with structural heart disease,” said Bernard Zovighian, Edwards’ CEO. “It starts with breakthrough innovation, layered with world class clinical expertise, sustained commitment and strong partnerships across the global healthcare ecosystem. Every advancement we make impacts a patient, a family and a community. Our purpose is to advance science and expand access so more people can benefit.”
This commitment extends through the Edwards Lifesciences Foundation and Every Heartbeat Matters, which increases access to diagnosis and treatment for underserved structural heart patients, particularly those in low- and middle-income countries and regions where care is limited and barriers may be substantial. Since 2014, Every Heartbeat Matters and its charitable partners have impacted more than 4 million underserved structural heart patients globally.
“Improving the lives of patients with structural heart disease is core to who we are,” Zovighian said. “Through Every Heartbeat Matters and our global partners, we are breaking down financial, systemic and geographic barriers so that underserved patients can get access to care that can change the trajectory of their lives. We innovate with purpose, we are powered by science and we remain centered on patients.”
More information on the Edwards Lifesciences Foundation and Every Heartbeat Matters is available at www.edwards.com/corporategiving or www.everyheartbeatmatters.org.
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as “may,” “will,” “should,” “anticipate,” “believe,” “plan,” “project,” “estimate,” “forecast,” “potential,” “predict,” "early clinician feedback," “expect,” “intend,” “guidance,” “outlook,” “optimistic,” “aspire,” “confident” or other forms of these words or similar expressions and include, but are not limited to, statements made by Mr. Zovighian, impact of Edwards’ therapies and innovation, including improving lives; access to care for underserved patients, changing the trajectory of their lives; and breaking down of barriers. No inferences or assumptions should be made from statements of past performance, efforts, or results which may not be indicative of future performance or results. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain, difficult to predict, and may be outside of the company’s control. The company's forward-looking statements speak only as of the date on which they are made and the company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the company does update or correct one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include risk and uncertainties associated with the risks detailed in the company's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025 and its other filings with the SEC. These filings, along with important safety information about our products, may be found at edwards.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260226865431/en/
Media Contact: Amy Meshulam, media@edwards.com
Investor Contact: Investor_Relations@edwards.com
Original: Edwards Lifesciences Advances Structural Heart Care Through Innovation and Purpose
US Market News
5月前
Edwards Lifesciences Reports Fourth Quarter ResultsFebruary 10, 2026 4:15 PM
Business Wire
Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter and full-year ended Dec. 31, 2025.
Highlights and Outlook
Q4 sales grew 13.3% to $1.57 billion1, constant currency2 sales grew 11.6%
Q4 TAVR sales grew 12.0% to $1.16 billion1; constant currency2 sales grew 10.6%
Q4 TMTT sales grew more than 40% to $156 million1 from repair and replacement therapies
Q4 EPS of $0.111; adjusted2 EPS of $0.58
FY 2025 sales grew 11.5%, 10.7% constant currency2
Increased confidence in FY 2026 constant currency2 sales growth of 8 – 10%
FY 2026 revenue outlook includes TMTT growing 35 – 45% to $740 – $780 million
Increased confidence in FY 2026 adjusted2 EPS $2.90 – $3.05
“Edwards’ strong fourth quarter and full year performance in 2025 reflect our differentiated strategy with a clear vision around three key elements: focusing solely on structural heart, solving large, urgent and very complex patient needs, and pursuing unique opportunities to innovate and lead, all achieved through excellent execution by our deeply experienced teams,” said Bernard Zovighian, Edwards’ CEO. “Based on multiple catalysts and the company’s strong fourth quarter performance, we have increased confidence in our outlook for 2026 and believe that our 70 years of expertise in valve innovation and world-class evidence will create sustainable growth and expanded profitability.
“These enduring catalysts benefitting Edwards in 2026 and the years ahead include distinguished long-term results unique to Edwards from the PARTNER 3 7-year and PARTNER 2 10-year trials, the impact of the practice-changing EARLY TAVR trial, new guidelines for treating aortic stenosis patients in Europe and the approvals of the first transcatheter mitral replacement therapy. We expect additional meaningful catalysts later in 2026 to fuel sustainable growth into the future, including next-generation TEER, PASCAL for U.S. tricuspid patients, continued scaling of EVOQUE and the potential of increased patient access from an updated TAVR NCD,” continued Zovighian.
Transcatheter Aortic Valve Replacement (TAVR)
In the fourth quarter, the company reported TAVR sales of $1.16 billion, which grew 12.0% versus the prior year, or 10.6% on a constant currency basis. Full-year 2025 global sales of $4.5 billion increased 8.6% year-over-year on a constant currency basis. U.S. and OUS sales growth rates were similar on a constant currency basis. The company’s procedural growth was comparable across the U.S. and OUS, and average price and competitive position was stable on a global basis.
In the U.S., the company saw intentional and urgent treatment of patients with severe aortic stenosis, fueled by a large and growing body of world-class evidence on the SAPIEN platform. The U.S. Centers for Medicare and Medicaid Services (CMS) formally opened the process to reconsider the National Coverage Determination for TAVR, a decision that has the potential to improve timely and equitable access to lifesaving TAVR therapy.
At TCT last October, the 7-year PARTNER 3 and 10-year PARTNER 2 data confirmed the long-term durability and proven valve performance of the SAPIEN platform. These data reinforce the confidence that physicians and patients have in Edwards’ TAVR and set a new clinical standard with Edwards’ transcatheter heart valve therapy for safety, efficacy, durability, and lifetime management of patients.
Edwards also expanded its partnership with the American Heart Association as the founding sponsor of the Heart Valve Initiative. This new multi-year initiative is focused on timely diagnosis and treatment to save lives and improve care for millions living with heart valve disease.
In Europe, fourth quarter results reflected healthy underlying TAVR procedure growth and Edwards’ consistent commercial execution across the region. The company continues to see modest year-over-year share improvement in the wake of a competitor’s exit. Updated guidelines from the European Society of Cardiology and European Association for Cardio-Thoracic Surgery are reshaping clinical discussions around proactive disease management and reinforcing the role of TAVR for a broader patient population.
Transcatheter Mitral and Tricuspid Therapies (TMTT)
The depth and breadth of Edwards’ portfolio of repair and replacement therapies to treat mitral and tricuspid diseases drove another quarter of strong growth. Fourth quarter TMTT sales grew more than 40% to $156 million. Global adoption of PASCAL and EVOQUE contributed to overall growth. The company continues to expand the number of centers and physician training while focusing on excellent patient outcomes.
The recent FDA approval of SAPIEN M3 expands Edwards’ mitral portfolio in the U.S. and represents the first transcatheter replacement option for patients suffering from mitral disease. Similar to other Edwards therapy launches, the strategic introduction of SAPIEN M3 is leveraging the company’s proven high value support model and focusing on outstanding clinical outcomes. Edwards is initially opening sites that were previously in the ENCIRCLE pivotal clinical trial, and physician focus and interest in this technology is growing.
With PASCAL and EVOQUE growing globally, and now with the introduction of SAPIEN M3 in the U.S. and Europe, Edwards continues to deliver on its vision of offering a portfolio of therapies and treating more patients in this globally underserved population with mitral and tricuspid disease. This comprehensive portfolio represents several layers of durable growth.
Surgical
In Surgical, fourth quarter global sales from continuing operations of $254 million increased 4% over the prior year, or 2% on a constant currency basis. Full-year Surgical sales of more than $1 billion grew 5%, or 4% on a constant currency basis, driven by continued adoption of RESILIA therapies that offer extended durability of Edwards’ surgical therapies including INSPIRIS, KONECT and MITRIS.
Edwards is pursuing multiple new innovations to advance Surgical solutions for patients, including Left Atrial Appendage Closure (LAAC). This therapeutic area is a complementary solution to specific valvular procedures, and the company is planning on a preliminary introduction of a new surgical LAAC technology later this year.
Additional Financial Results
For the quarter, the gross profit margin was 78.1%, or 78.3% adjusted, compared to 78.9%, or 79.0% adjusted, in the same period last year. The company continues to expect its full-year 2026 adjusted gross profit margin to be between 78% and 79%.
Selling, general and administrative expenses in the fourth quarter were $603 million, or 38.4% of sales, compared to 35.5% of sales in the prior year. This increase funded strategic investments to amplify patient access to therapy. Some of this strategic spending was delayed from previous quarters in the year. Research and development expenses in the fourth quarter were $268 million, or 17.1% of sales, compared to 19.6% in the prior year. The company continues to expect its full-year 2026 R&D as a percentage of sales to be approximately 17%.
Operating profit margin in the fourth quarter of 9.6%, or 23.7% adjusted, was in line with the company’s previous guidance of mid-20% for the quarter. Adjusted EPS was $0.58, which also included a higher-than-expected tax rate for the quarter. In 2026, Edwards expects full-year operating profit margin at the high end of the original 28% to 29% guidance range.
Cash and cash equivalents were approximately $3.0 billion as of Dec. 31, 2025. Total debt was approximately $600 million.
Outlook
Edwards has increased confidence in meeting its 2026 sales growth rate guidance of 8 to 10% and EPS guidance of $2.90 to $3.05. For the first quarter of 2026, the company projects total sales to be between $1.55 and $1.63 billion and adjusted EPS of $0.70 to $0.76.
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.
Conference Call and Webcast Information
The company will be hosting a conference call today at 2:00 p.m. PT to discuss its fourth quarter results. To participate in the conference call, dial (877) 704-2848 or (201) 389-0893. The call will also be available live and archived on the “Investor Relations” section of the Edwards website at ir.edwards.com or www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as “may,” “will,” “should,” “anticipate,” “believe,” “plan,” “project,” “estimate,” “forecast,” “potential,” “predict,” “early clinician feedback,” “expect,” “intend,” “guidance,” “outlook,” “optimistic,” “aspire,” “confident” or other forms of these words or similar expressions and include, but are not limited to, statements made by Mr. Zovighian, including the creation of sustainable growth and expanded profitability; first quarter and fiscal year 2026 financial guidance; statements regarding enduring catalysts such as PARTNER 3 7-year and PARTNER 2 10-year trials, EARLY TAVR, new guidelines for patients in Europe, and therapy approvals; statements regarding expected catalysts, including next generation TEER, PASCAL system, EVOQUE, and increased patient access from an updated NCD; expanded indication to include asymptomatic severe AS patients; transformation of patient care and treatment; quality of clinical and patient outcomes and impacts; technologies delivering strong and positive growth; expectations for R&D spending; expanding opportunity to meet patient needs; introduction of a new surgical technology; regulatory approvals, and the information in the Outlook section. No inferences or assumptions should be made from statements of past performance, efforts, or results which may not be indicative of future performance or results. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain, difficult to predict, and may be outside of the company’s control. The company's forward-looking statements speak only as of the date on which they are made and the company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the company does update or correct one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include risk and uncertainties associated with the risks detailed in the company's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, and its other filings with the SEC. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, EARLY TAVR, EVOQUE, INSPIRIS, KONECT, MITRIS, PARTNER, PARTNER 3, PASCAL, RESILIA, SAPIEN, SAPIEN M3, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN M3 are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
___________________
[1]
Reported sales and diluted EPS are from continuing operations.
[2]
The company uses the terms “adjusted” and “constant currency” when referring to non-GAAP sales from continuing operations and sales growth information, respectively, which excludes currency rate fluctuations and newly acquired products. Adjusted earnings per share from continuing operations is a non-GAAP item computed on a diluted basis and in this press release also excludes certain litigation expenses, amortization of intangible assets, separation costs, intangible assets impairment charges, fair value adjustments to contingent consideration liabilities, loss on impairment, restructuring expenses, charitable contribution to the Edwards Lifesciences Foundation, acquisition contract termination costs, and a gain on remeasurement of previously held interest upon acquisition. See “Non-GAAP Financial Information” and reconciliation tables below.
EDWARDS LIFESCIENCES CORPORATION
Unaudited Consolidated Statements of Operations
(in millions, except per share data)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2025
2024
2025
2024
Net sales
$
1,569.6
$
1,385.8
$
6,067.6
$
5,439.5
Cost of sales
343.0
292.2
1,334.2
1,117.5
Gross profit
1,226.6
1,093.6
4,733.4
4,322.0
Selling, general, and administrative expenses
602.9
491.9
2,085.2
1,789.2
Research and development expenses
267.7
271.1
1,079.2
1,053.0
Intellectual property agreement and certain litigation expenses
208.6
12.6
325.4
40.4
Change in fair value of contingent consideration liabilities
—
—
(12.5
)
—
Restructuring charges, separation costs and other
10.6
28.1
19.1
61.0
Intangible assets impairment charges
—
—
40.0
—
Other operating income
(14.3
)
(22.7
)
(67.2
)
(0.3
)
Operating income, net
151.1
312.6
1,264.2
1,378.7
Interest income, net
(35.9
)
(44.2
)
(148.4
)
(100.5
)
Loss on impairment
99.8
—
146.9
—
Other non-operating income, net
(3.2
)
(33.3
)
(7.2
)
(68.9
)
Income from continuing operations before provision for income taxes
90.4
390.1
1,272.9
1,548.1
Provision for income taxes
26.2
45.1
216.9
152.1
Net income from continuing operations
64.2
345.0
$
1,056.0
$
1,396.0
Income from discontinued operations, net of tax
27.0
39.3
13.4
2,773.7
Net income
91.2
384.3
1,069.4
4,169.7
Net loss attributable to noncontrolling interest
—
(1.3
)
(4.1
)
(4.9
)
Net income attributable to Edwards Lifesciences Corporation
$
91.2
$
385.6
$
1,073.5
$
4,174.6
Earnings per share:
Basic:
Continuing operations
$
0.11
$
0.58
$
1.81
$
2.34
Discontinued operations
$
0.05
$
0.07
$
0.03
$
4.64
Basic earnings per share
$
0.16
$
0.65
$
1.84
$
6.98
Diluted:
Continuing operations
$
0.11
$
0.58
$
1.81
$
2.34
Discontinued operations
$
0.05
$
0.07
$
0.02
$
4.63
Diluted earnings per share
$
0.16
$
0.65
$
1.83
$
6.97
Weighted-average common shares outstanding:
Basic
580.4
589.8
584.8
597.7
Diluted
581.8
590.5
585.8
599.3
Operating statistics from continuing operations
As a percentage of net sales:
Gross profit
78.1
%
78.9
%
78.0
%
79.5
%
Selling, general, and administrative expenses
38.4
%
35.5
%
34.4
%
32.9
%
Research and development expenses
17.1
%
19.6
%
17.8
%
19.4
%
Operating income
9.6
%
22.6
%
20.8
%
25.3
%
Income before provision for income taxes
5.8
%
28.1
%
21.0
%
28.5
%
Net income from continuing operations
4.1
%
24.9
%
17.4
%
25.7
%
Effective tax rate
29.0
%
11.6
%
17.0
%
9.8
%
__________________
Note: Numbers may not calculate due to rounding.
EDWARDS LIFESCIENCES CORPORATION
Non-GAAP Financial Information
To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles (“GAAP”), the Company uses non-GAAP historical financial measures. Management makes adjustments to the GAAP measures for items (both charges and gains) that (a) do not reflect the core operational activities of the Company, (b) are commonly adjusted within the Company’s industry to enhance comparability of the Company’s financial results with those of its peer group, or (c) are inconsistent in amount or frequency between periods (albeit such items are monitored and controlled with equal diligence relative to core operations). The Company uses the terms “adjusted” and “constant currency” when referring to non-GAAP sales from continuing operations and sales growth information, respectively, which excludes currency exchange rate fluctuations and newly acquired products. The Company uses the term “adjusted” to also exclude certain litigation expenses, amortization of intangible assets, separation costs, intangible assets impairment charges, fair value adjustments to contingent consideration liabilities, loss on impairment, restructuring expenses, charitable contribution to the Edwards Lifesciences Foundation, acquisition contract termination costs, and a gain on remeasurement of previously held interest upon acquisition.
Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results, and evaluating current performance. These non-GAAP financial measures are used in addition to, and in conjunction with, results presented in accordance with GAAP and reflect an additional way of viewing aspects of the Company's operations by investors that, when viewed with its GAAP results, provide a more complete understanding of factors and trends affecting the Company's business and facilitate comparability to historical periods.
Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. A reconciliation of non-GAAP historical financial measures to the most comparable GAAP measure is provided in the tables below.
Fluctuations in currency exchange rates impact the comparative results and sales growth rates of the Company's underlying business. Management believes that excluding the impact of currency exchange rate fluctuations from its sales growth provides investors a more useful comparison to historical financial results. The impact of the fluctuations has been detailed in the “Reconciliation of Sales by Product Group and Region.”
Guidance for sales and sales growth rates is provided on a “constant currency basis,” and projections for diluted earnings per share, net income and growth, gross profit margin, and taxes are also provided on a non-GAAP basis, as adjusted, for the items identified above due to the inherent difficulty in forecasting such items without unreasonable efforts. The Company is not able to provide a reconciliation of the non-GAAP guidance to comparable GAAP measures due to the unknown effect, timing, and potential significance of special charges or gains, and management's inability to forecast charges associated with future transactions and initiatives.
The items described below are adjustments to the GAAP financial results in the reconciliations that follow:
Certain Litigation Expenses - The Company incurred certain litigation expenses of $10.9 million and $8.9 million in the first quarter of 2025 and 2024, respectively, $15.5 million and $8.1 million for the second quarter of 2025 and 2024, respectively, $90.4 million and $10.8 million for the third quarter of 2025 and 2024, respectively, and $208.6 million and $12.6 million in the fourth quarter of 2025 and 2024, respectively. Such expenses relate to intellectual property litigation, settlements, contingencies, and external legal costs.
Amortization of Intangible Assets - The Company recorded amortization expense related to developed technology and patents in the amount of $1.4 million and $0.5 million in the first quarter of 2025 and 2024, respectively, $1.8 million and $1.2 million in the second quarter of 2025 and 2024, respectively, $1.7 million and $1.3 million in the third quarter of 2025 and 2024, respectively, and $2.4 million and $1.4 million in the fourth quarter of 2025 and 2024, respectively.
Separation Costs - The Company recorded expenses of $4.2 million in both the first and second quarter of 2025, $0.1 million in the third quarter of 2025, and $19.0 million in the fourth quarter of 2024, related to consulting, legal, tax, and other professional advisory services related to the sale of Critical Care.
Intangible assets impairment charges - The Company recorded a $40.0 million charge in the third quarter of 2025 related to an impairment of certain developed technology asset acquired as part of an acquisition.
Change in Fair Value of Contingent Consideration Liabilities - The Company recorded a gain of $12.5 million in the third quarter of 2025 related to changes in the fair value of its contingent consideration liabilities arising from acquisitions.
Loss on Impairment - The Company recorded loss on impairment of $47.1 million in the second quarter of 2025 ($36.0 million net of tax adjustment), related to the Company's determination to not exercise an option to acquire one of its VIE investments. In addition, the Company recorded $99.8 million ($76.5 million net of tax) in the fourth quarter of 2025, related to impairment of its investment in JenaValve Technologies.
Restructuring Expenses - The Company recorded a $32.9 million charge in the third quarter of 2024 and $8.9 million charge in the fourth quarter of 2025 primarily related to severance expenses associated with a global workforce realignment.
Charitable Foundation Contribution - The Company recorded a $30.0 million charge in Other operating (income) expense, net in the third quarter of 2024 for a charitable contribution to the Edwards Lifesciences Foundation.
Acquisition Contract Termination Costs - The Company recorded expenses of $1.7 million and $9.1 million in the fourth quarter of 2025 and 2024, respectively, related to the termination of certain contracts associated with the Company's acquisitions.
Gain on Remeasurement of Previously Held Interest Upon Acquisition - The Company recorded a $24.6 million gain in the third quarter of 2024 and a $30.5 million gain in the fourth quarter of 2024 to remeasure its previously held interest upon acquisition of the investee.
Provision for Income Taxes - The income tax impacts of the expenses and gains discussed above are based upon the items' actual effect upon the Company's full-year effective tax rate. Adjustments to forecasted items unrelated to the expenses and gains above, as well as impacts related to interim reporting, will have an effect on the income tax impact of these items in subsequent periods.
EDWARDS LIFESCIENCES CORPORATION
Unaudited Reconciliation of GAAP to Non-GAAP Financial Information
(in millions, except per share and percentage data)
Three Months Ended December 31, 2025
Net Sales
Gross
Profit
Margin
Operating
Income,
net
Operating
Profit
Margin
Other
Non-operating
Income
Net
Income
Diluted
EPS
Effective
Tax Rate
GAAP - Continuing Operations
$
1,569.6
78.1
%
$
151.1
9.6
%
$
3.2
$
64.2
$
0.11
29.0
%
Net loss attributable to noncontrolling interests
—
—
—
—
—
—
—
—
Total attributable to Edwards Lifesciences Corporation
1,569.6
78.1
%
151.1
9.6
%
3.2
64.2
0.11
29.0
%
Non-GAAP adjustments: (A) (B)
Certain litigation expenses
—
—
208.6
13.2
—
187.1
0.32
(9.7
)
Amortization of intangible assets
—
0.2
2.4
0.2
—
1.7
—
—
Restructuring expenses
—
—
8.9
0.6
—
6.8
0.01
(0.2
)
Acquisition contract termination costs
—
—
1.7
0.1
—
1.7
—
(0.2
)
Loss on impairment
—
—
—
—
—
76.5
0.14
(1.0
)
Prior period ongoing tax impacts
—
—
—
—
—
(0.1
)
—
—
Adjusted
$
1,569.6
78.3
%
$
372.7
23.7
%
$
3.2
$
337.9
$
0.58
17.9
%
Three Months Ended December 31, 2024
Net Sales
Gross
Profit
Margin
Operating
Income,
net
Operating
Profit
Margin
Other
Non-operating
Income
Net
Income
Diluted
EPS
Effective
Tax Rate
GAAP - Continuing Operations
$
1,385.8
78.9
%
$
312.6
22.6
%
$
33.3
$
345.0
$
0.58
11.6
%
Net loss attributable to noncontrolling interests
—
—
—
—
—
1.3
—
—
Total attributable to Edwards Lifesciences Corporation
1,385.8
78.9
%
312.6
22.6
%
33.3
346.3
0.58
11.6
%
Non-GAAP adjustments: (A) (B)
Certain litigation expenses
—
—
12.6
0.9
—
8.4
0.02
0.7
Amortization of intangible assets
—
0.1
1.4
0.1
—
1.1
—
—
Separation costs
—
—
19.0
1.4
—
14.5
0.02
0.5
Acquisition contract termination costs
—
—
9.1
0.6
—
8.1
0.02
(0.1
)
Gain on remeasurement of previously held interest upon acquisition
—
—
—
—
(30.5
)
(27.0
)
(0.05
)
—
Prior period ongoing tax impacts
—
—
—
—
—
(2.0
)
—
0.6
Adjusted
$
1,385.8
79.0
%
$
354.7
25.6
%
$
2.8
$
349.4
$
0.59
13.3
%
Twelve Months Ended December 31, 2025
Net
Sales
Gross
Profit
Margin
Operating
Income
Operating
Profit
Margin
Other
Non-operating
Income
Net
Income
Diluted
EPS
Effective
Tax Rate
GAAP - Continuing Operations
$
6,067.6
78.0
%
$
1,264.2
20.8
%
$
7.2
$
1,056.0
$
1.81
17.0
%
Net loss attributable to noncontrolling interests
—
—
—
—
—
4.1
—
—
Total attributable to Edwards Lifesciences Corporation
6,067.6
78.0
%
1,264.2
20.8
%
7.2
1,060.1
1.81
17.0
%
Non-GAAP adjustments: (A) (B)
Certain litigation expenses
—
—
325.4
5.5
—
277.5
0.48
—
Amortization of intangible assets
—
0.1
7.3
0.1
—
5.6
—
—
Separation costs
—
—
8.5
0.1
—
6.5
0.01
—
Restructuring expenses
—
—
8.9
0.1
—
6.8
0.01
—
Intangible assets impairment charges
—
—
40.0
0.7
—
40.0
0.07
—
Change in fair value of contingent consideration liabilities
—
—
(12.5
)
(0.2
)
—
(12.5
)
(0.02
)
—
Acquisition contract termination costs
—
—
1.7
—
—
1.7
—
—
Loss on impairment
—
—
—
—
—
112.5
0.20
—
Adjusted
$
6,067.6
78.1
%
$
1,643.5
27.1
%
$
7.2
$
1,498.2
$
2.56
17.0
%
Twelve Months Ended December 31, 2024
Net
Sales
Gross
Profit
Margin
Operating
Income
Operating
Profit
Margin
Other
Non-operating
Income
Net
Income
Diluted
EPS
Effective
Tax Rate
GAAP - Continuing Operations
$
5,439.5
79.5
%
$
1,378.7
25.3
%
$
68.9
$
1,396.0
$
2.34
9.8
%
Net loss attributable to noncontrolling interests
—
—
—
—
—
4.9
—
—
Total attributable to Edwards Lifesciences Corporation
5,439.5
79.5
%
1,378.7
25.3
%
68.9
1,400.9
2.34
9.8
%
Non-GAAP adjustments: (A) (B)
Certain litigation expenses
—
—
40.4
0.7
—
30.4
0.05
0.3
Amortization of intangible assets
—
—
4.4
0.1
—
3.5
—
—
Restructuring expenses
—
—
32.9
0.6
—
25.9
0.05
0.2
Charitable foundation contribution
—
—
30.0
0.6
—
22.7
0.04
0.3
Separation costs
—
—
19.0
0.3
—
14.5
0.02
0.2
Acquisition contract termination costs
—
—
9.1
0.2
—
8.1
0.02
0.1
Gain on remeasurement of previously held interest upon acquisition
—
—
—
—
(55.1
)
(51.6
)
(0.09
)
0.1
Prior period ongoing tax impacts
—
—
—
—
—
0.8
—
—
Adjusted
$
5,439.5
79.5
%
$
1,514.5
27.8
%
$
13.8
$
1,455.2
$
2.43
11.0
%
__________________
(A)
See description of non-GAAP adjustments under “Non-GAAP Financial Information.”
(B)
The tax effect on non-GAAP adjustments is calculated based upon the impact of the relevant tax jurisdictions’ statutory tax rates on the Company’s estimated annual effective tax rate, or discrete rate in the quarter, as applicable. The impact on the effective tax rate is reflected on each individual non-GAAP adjustment line item.
RECONCILIATION OF SALES BY PRODUCT GROUP AND REGION
2025 Adjusted
2024 Adjusted
Sales by Product Group (QTD) - Continuing Operations
4Q 2025
4Q 2024
Change
GAAP
Growth
Rate*
Implantable
Heart
Failure
Management (A)
4Q 2025
Adjusted
Sales
FX
Impact
4Q 2024
Adjusted
Sales
Constant
Currency
Growth
Rate *
Transcatheter Aortic Valve Replacement
$
1,160.3
$
1,036.3
$
124.0
12.0
%
$
—
$
1,160.3
$
13.5
$
1,049.8
10.6
%
Transcatheter Mitral and Tricuspid Therapies
155.7
105.1
50.6
48.3
%
—
155.7
2.9
108.0
44.1
%
Surgical Structural Heart
253.6
244.4
9.2
3.8
%
—
253.6
3.7
248.1
2.2
%
Total
$
1,569.6
$
1,385.8
$
183.8
13.3
%
$
—
$
1,569.6
$
20.1
$
1,405.9
11.6
%
2025 Adjusted
2024 Adjusted
Sales by Product Group (YTD) - Continuing Operations
YTD
4Q 2025
YTD
4Q 2024
Change
GAAP
Growth
Rate*
Implantable
Heart
Failure
Management (A)
YTD 4Q
2025
Adjusted
Sales
FX
Impact
YTD 4Q
2024
Adjusted
Sales
Constant
Currency
Growth
Rate *
Transcatheter Aortic Valve Replacement
$
4,487.7
$
4,106.1
$
381.6
9.3
%
$
—
$
4,487.7
$
26.7
$
4,132.8
8.6
%
Transcatheter Mitral and Tricuspid Therapies
550.6
352.1
198.5
56.4
%
(3.0
)
547.6
5.8
357.9
53.1
%
Surgical Structural Heart
1,029.3
981.3
48.0
4.9
%
—
1,029.3
5.9
987.2
4.3
%
Total
$
6,067.6
$
5,439.5
$
628.1
11.5
%
$
(3.0
)
$
6,064.6
$
38.4
$
5,477.9
10.7
%
2025 Adjusted
2024 Adjusted
Sales by Region (QTD) - Continuing Operations
4Q 2025
4Q 2024
Change
GAAP
Growth
Rate*
Implantable
Heart
Failure
Management (A)
4Q 2025
Adjusted
Sales
FX
Impact
4Q 2024
Adjusted
Sales
Constant
Currency
Growth
Rate *
United States
$
907.0
$
812.9
$
94.1
11.6
%
$
—
$
907.0
$
—
$
812.9
11.6
%
Europe
409.6
343.7
65.9
19.1
%
—
409.6
22.3
366.0
11.9
%
Japan
87.5
85.9
1.6
1.9
%
—
87.5
(1.7
)
84.2
3.9
%
Rest of World
165.5
143.3
22.2
15.5
%
—
165.5
(0.5
)
142.8
15.9
%
Outside of the United States
662.6
572.9
89.7
15.6
%
—
662.6
20.1
593.0
11.7
%
Total
$
1,569.6
$
1,385.8
$
183.8
13.3
%
$
—
$
1,569.6
$
20.1
$
1,405.9
11.6
%
2025 Adjusted
2024 Adjusted
Sales by Region (YTD) - Continuing Operations
YTD
4Q 2025
YTD
4Q 2024
Change
GAAP
Growth
Rate*
Implantable
Heart
Failure
Management (A)
YTD 4Q
2025
Adjusted
Sales
FX
Impact
YTD 4Q
2024
Adjusted
Sales
Constant
Currency
Growth
Rate *
United States
$
3,543.1
$
3,206.0
$
337.1
10.5
%
$
(3.0
)
$
3,540.1
$
—
$
3,206.0
10.4
%
Europe
1,517.5
1,321.7
195.8
14.8
%
—
1,517.5
44.6
1,366.3
11.1
%
Japan
354.7
339.8
14.9
4.4
%
—
354.7
3.2
343.0
3.4
%
Rest of World
652.3
572.0
80.3
14.0
%
—
652.3
(9.4
)
562.6
15.9
%
Outside of the United States
2,524.5
2,233.5
291.0
13.0
%
—
2,524.5
38.4
2,271.9
11.1
%
Total
$
6,067.6
$
5,439.5
$
628.1
11.5
%
$
(3.0
)
$
6,064.6
$
38.4
$
5,477.9
10.7
%
__________________
(A)
For the fourth quarter 2025, $2.1 million of revenues related to Implantable Heart Failure Management (“IHFM”) are included in TMTT and accounted as a part of its constant currency growth rates. For the year-to-date 2025, amounts represent revenues related to IHFM for January 2025 through August 2025. Beginning September 2025, $2.7 million of revenues related to IHFM are included in TMTT and accounted as a part of its constant currency growth rates.
* Numbers may not calculate due to rounding.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260210513744/en/
Media: Amy Meshulam, 949-250-4009, media@edwards.com
Investors: investor_relations@edwards.com
Original: Edwards Lifesciences Reports Fourth Quarter Results
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