Edwards Lifesciences Reports First Quarter Results

Edwards Lifesciences (NYSE:EW) today reported financial results for the quarter ended Mar. 31, 2025.

Recent Highlights

• Q1 sales grew 6.2% to $1.41 billion, or 7.9% adjusted¹
• Q1 TAVR sales grew 3.8%; constant currency¹ sales grew 5.4%, better than expected
• Q1 TMTT sales grew 58% to $115 million with meaningful contribution to Edwards' growth
• Q1 EPS of $0.62²; adjusted¹ EPS of $0.64
• SAPIEN M3 CE Mark approval uniquely positions Edwards with a comprehensive TMTT portfolio
• NCD finalized for transcatheter tricuspid valve replacement, expanding patient access to EVOQUE
• Multiple TAVR studies presented at ACC confirm the need for urgent patient referral to Heart Team
• Data from Heart Valve Society meeting confirm long-term durability of Edwards' RESILIA tissue

2025 Outlook

• Raising TMTT sales guidance range to $530 million to $550 million
• Reiterating TAVR and Surgical sales growth guidance
• Reiterating 8-10% Edwards sales growth guidance; increasing sales guidance to $5.7 to $6.1 billion
• Reaffirming adjusted EPS of $2.40 to $2.50, including estimated JenaValve dilution and tariff impact

"The many milestones achieved this quarter are the result of our structural heart-focused strategy and our decades of unwavering dedication to driving breakthrough innovation in pioneering and leading categories. Collectively, these milestones mark the significant progress we have made to unlock this large and growing opportunity to transform care for millions of structural heart patients around the world," said Bernard Zovighian, CEO. "We are pleased with our strong start to the year and have confidence in our 2025 outlook. Looking to the future, we will build on the many impactful catalysts for our company, which position us for distinguished growth in the years ahead."

Transcatheter Aortic Valve Replacement (TAVR)

In the first quarter, the company reported TAVR sales of $1.05 billion, which grew 3.8% versus the prior year, 5.4% on a constant currency basis, or 6.5% further adjusted for one less billing day. Constant currency growth was comparable in the United States ("U.S.") and Outside of the United States ("OUS"). Edwards' strong competitive position and pricing remained stable globally, with some regional variability.

In the U.S., the company's leading SAPIEN 3 Ultra RESILIA platform continues to demonstrate strong performance. Edwards is advancing initiatives to help hospitals treat structural heart patients efficiently and manage increasing procedure volumes. The company remains encouraged by hospitals that have demonstrated the ability to scale to accommodate procedure growth. Edwards is encouraged by discussions with key clinicians on the long-term impact of the EARLY TAVR data to streamline patient care. In addition, Edwards expects asymptomatic indication approval in the second quarter.

Outside of the U.S., the company continues to focus on the value of its differentiated technology and increasing therapy adoption, especially in areas where TAVR remains underutilized and many patients go without care. In the first quarter, sales growth in Europe was supported by the continued expansion of SAPIEN 3 Ultra RESILIA. In Japan, Edwards remains dedicated to addressing the significant undertreatment of aortic stenosis among the substantial elderly population in Japan.

Transcatheter Mitral and Tricuspid Therapies (TMTT)

Edwards' unique and increasingly differentiated TMTT portfolio drove another quarter of impressive growth, with a meaningful contribution to overall company performance. First quarter sales were $115 million, representing growth of 58% year-over-year, or more than 60% on a constant currency basis, led by increased adoption and balanced contribution from PASCAL and EVOQUE in the U.S., Europe and globally.

PASCAL continues to demonstrate its value for patient care. Its differentiated features are driving distinguished clinical outcomes, and adoption is increasing at both new and existing sites around the world. The EVOQUE commercial launch is progressing well in the U.S. and Europe, with continuing excellent patient outcomes. The recent CE Mark approval of the SAPIEN M3 in Europe, the world's first transcatheter mitral valve replacement system, will benefit many patients with mitral regurgitation who have limited treatment options.

With EVOQUE, SAPIEN M3 and PASCAL, Edwards is uniquely positioned to meet the broad and diverse needs of patients with tricuspid and mitral valve diseases.

Surgical

In Surgical, first quarter global sales of $251 million increased 1% over the prior year, or 3% on a constant currency basis. The company continues to see positive procedure growth globally for the many patients best treated with Edwards' premium RESILIA tissue portfolio including MITRIS, INSPIRIS and KONECT.

Also in the first quarter, Edwards made progress advancing important innovations around the world. MITRIS launched in China with positive surgeon feedback. Additionally, the company anticipates receiving CE Mark approval for the KONECT aortic valved conduit in Europe before year-end.

Additional Financial Results

For the quarter, the gross profit margin was 78.7% compared to 78.4% in the same period last year.

Selling, general and administrative expenses in the first quarter were $466 million, or 33.0% of sales, which was better than the company's expectation for the quarter driven by lower sequential spending and deferral of certain strategic investments originally planned for Q1.

Research and development expense of $255 million in the quarter was equivalent to 18.0% of sales, a reduction from 19.6% of sales in the previous quarter. This lower ratio of spending reflects the company's prioritized investments in its structural heart portfolio in areas where Edwards believes there are significant opportunities for profitable growth.

Operating profit margin in the first quarter of 27.9%, or 29.1% adjusted, was driven by better-than-expected sales and favorable mix, as well as some variable expenses delayed beyond Q1.

Cash and cash equivalents were approximately $3.1 billion as of March 31, 2025. Total debt was approximately $600 million.

Outlook

Edwards is raising its 2025 TMTT sales guidance range to $530 to $550 million, from $500 million to $530 million, driven by more favorable foreign exchange and continued business momentum. Separately, total company, TAVR and Surgical sales growth guidance ranges remain unchanged, but the company is increasing its original total company sales dollar guidance range by $100 million to account for recent movement in FX rates. Edwards now expects total company sales of $5.7 to $6.1 billion in 2025. The company expects pressure on its operating margin as a result of the weakening dollar, the impact of announced tariffs and the expected close of the JenaValve acquisition. However, the company is implementing plans to mitigate these anticipated costs and maintains its full-year operating margin guidance of 27% to 28% and EPS guidance of $2.40 to $2.50. For the second quarter of 2025, the company projects total sales to be between $1.45 and $1.53 billion and adjusted EPS of $0.59 to $0.65.

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, second quarter and fiscal year 2025 financial guidance, our expected growth and accelerating growth due to, among other things, asymptomatic TAVR approval; durability of our RESILIA tissue; global adoption of, and differentiated features of, our devices; scaling of hospitals to accommodate procedure growth; expansion of evidence, approvals, clinical trial outcomes and impacts; patient outcomes; expectations for R&D and SG&A spending; effects of the JenaValve transaction; the highlights in the Guidance and Outlook section 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.

Edwards' guidance reflects the Company's current estimates of the impact from tariffs that are in effect or have been announced as of the time of this press release and assumes such tariffs remain in place for the remainder of 2025. Any modification to such tariffs, or any new tariffs, could have a material impact on the Company's future financial results and guidance.

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, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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, 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, taxes, and free cash flow 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.

Management considers free cash flow to be a liquidity measure which provides useful information to management and investors about the amount of cash generated by business operations, after deducting payments for capital expenditures, which can then be used for strategic opportunities or other business purposes including, among others, investing in the Company's business, making strategic acquisitions, strengthening the balance sheet, and repurchasing stock.

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.

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.

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.

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.

RECONCILIATION OF SALES BY PRODUCT GROUP AND REGION

* Numbers may not calculate due to rounding.

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Media Contact: Amy Meshulam, 949-250-4009

Investor Contact: Mark Wilterding, 949-250-6826