Edwards Lifesciences Corporation

Greetings and welcome to the Edwards Life Sciences first quarter 2026 results. At this time, all participants are in a listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Jerrianne Sarte, Senior Vice President, Investor Relations. Thank you. You may begin.

Good afternoon, and thank you for joining us. With me on today's call is our CEO, Bernard Zavigian, and our CFO, Scott Ullum. Also joining us for the Q&A portion of the call will be Dan Lithis, our global leader of TAVR, and Devine Chopra, who has global responsibility for TMTT, surgical, and IHFM. After the close of regular trading, Edwards Life Sciences released first quarter 2026 financial results During today's call, management will discuss the results included in the press release and accompanying financial schedules, and then use the remaining time for Q&A. Please note that management will be making forward-looking statements that are based on estimates, assumptions, and projections. These statements speak only as of the date on which they are made, and Edwards does not undertake any obligation to update them after today. Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause these differences can be found in today's press release and Edwards' other SEC filings, all of which are available on the company's website at edwards.com. Unless otherwise noted, our commentary on sales growth refers to underlying sales growth, which is defined in the financial results press release issued earlier today. Reconciliations between gaps and non-gap numbers mentioned during this call are also included in today's press release. Quarterly and full-year growth rates refer to continuing operations. With that, I'll turn the call over to Bernard for his comments.

Thank you, Gerian, and welcome, everyone. Building on a year in 2025 marked by solid financial performance, and strategic progress, we delivered another strong quarter in Q1, achieving 12.7% self-growth, which reflects the impact and durability of our differentiated strategy. Our focus on structural heart disease solves large, urgent, and complex patient needs. and allows us to pursue unique opportunities to innovate and lead. None of this will be possible without the exceptional talent of our employees who bring our culture to life each day through their dedication to patients. We've built a workplace where our 16,000 employees around the world can stay and grow with us. I want to thank each of them for being aligned to our vision inspired in their work, and committed for the long term, which is essential to our continued impact for patients. Our strategy is underpinned by speed, agility, and discipline execution, which enables our differentiated, sustainable growth. Developing safe and effective valve therapies requires unwavering focus. deep expertise, and the generation of world-class evidence capabilities that distinguish Edwards as a trusted partner. While it takes time to pioneer new therapeutic areas and change the practice of medicine, our innovative therapies have transformed care for many patients and positioned Edwards to continue to lead for many years to come. Looking forward, we are reinforcing our foundation with multiple strategic investments focused on clinical evidence generation, technology advancements, indication expansions, and resources to support patient care. We continue to pursue additional meaningful growth opportunities in each therapeutic category that will have a positive impact on our performance in 2027 and beyond. In TAVR, there is a running focus on the therapy across the healthcare ecosystem. This has been reinforced by definitive 7-year partner 3 and 10-year partner 2 data, which validate the durability and consistent performance of SAPIEN. Our platform is distinguished by high-quality, long-term evidence, grounded in decades of scientific rigor. In addition, the practice-changing early tether trial results are resonating with the clinical community, validating the movement away from the outdated practice of watchful waiting and further highlighting the importance of intentional referral and treatment earlier in the disease pathway for severe aortic stenosis. Together, our sapient innovation and evidence have once again elevated the standard for current and future taverval performance, durability, and lifestyle management of patients with aortic stenosis. In TMCT, our many years of patient-focused commitment, pioneering development, and strategic investments have resulted in a unique, comprehensive portfolio of therapies that enables physicians to offer options to the clinically diverse population of patients suffering from mitral and tricuspid diseases. With a complementary portfolio of repair and replacement technologies across both valves, we have expanded the population of patients who can benefit from these technologies. We remain deeply committed to ongoing innovation and the generation of high quality clinical evidence to reach even more people affected by these diseases. In surgical, We continue to expand our portfolio to address the needs of the many structural heart patients best treated surgically. Our portfolio of resilient tissue technologies, including Inspiris, Connect, and Mitris, is backed by years of durability data and continue to support enhanced patient care globally. The success of our structural health strategy is evidenced by the significant opportunities across surgical, TAVR, mitral and trachea speed, and we are in a unique position to advance new technologies, next generation of existing technologies, and to expand indication to benefit even more patients. In addition, we are executing our proven innovation strategy to expand into structural heart failure and aortic regurgitation, which represent significant longer-term growth opportunities. We remain steadfast in our commitment to address patients in need by advancing novel therapies to extend life, improve quality of life, and provide greater impact and efficiency for health systems. Turning to our financial performance, Edwards continues to be well positioned to invest in innovation while also generating attractive financial results. In 2027 and beyond, we believe our strategy will enable average annual sales growth of approximately 10% as well as operating margin expansion. We expect variability in sales growth rates over time based on the timing of catalysts. Our financial strength and strategic clarity give us confidence in the future. In the first quarter, we generated 12.7% sales growth and strong earnings performance for Edwards, both ahead of expectation driven by broad-based growth across our product groups. Based on our first quarter outperformance, we are raising our full year 2026 sales growth guidance to 9% to 11% and adjusted EPS guidance to $2.95 to $3.05, which demonstrates solid earnings leverage. Now I will provide more detail about product group performance. TAVR first quarter global sales of $1.2 billion increased 11% over the prior year. Globally, procedural growth benefited from a heightened clinical focus on proactive disease management of severe AS, along with long-term evidence demonstrated the proven durability and valve performance of the SAPI platform. Sapien growth in the U.S. was healthy, and it was even faster outside of the U.S. Edouard's 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. Recent clinical trial results on long-term TAVR performance continue to support patient treatment with Sapien TAVR. We are 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 sapient outcomes data, reinforces our confidence in the durable multi-year growth opportunity ahead. Over our 70-year history of continuous value innovation, we have devoted our deep knowledge, experience and learning to the complex research and development, clinical studies, and manufacturing of surgical and trans-catheter half valves. Each innovation represents a unique challenge. We know the impact of these advanced technologies, and over time, we have seen multiple examples of other valve platforms showing variable performance, which is the reason why long-term clinical evidence from rigorous FDA trials must continue to guide therapy choice for patients. We are confident in our sapient TAVR therapy with distinguished valve performance, proven long-term clinical evidence, including the 7-year parneur-free data and 10-year parneur-2 data, and enhanced asymptomatic indication, all of which are meaningful differentiators. Later this year, We will also learn more about patients with moderate AS when the progress trial results are presented at the TCT conference. Let me now turn to some commentary on US TAVR. In Q1, procedure growth continued to benefit. from the heightened clinical focus on proactive management of severe AS as the clinical community continues to digest and incorporate new evidence into patient care. We believe Edward's competitive position also benefited slightly year over year. We are also pleased that CMS is conducting the process to reconsider the NCD for TAVR. This decision has the potential to improve timely access to life-saving tether therapy. The initial 30-day public comment period closed on January 14 of this year, and we look forward to the next steps in the process, including the release of a draft decision memo by June 15 of this year. In Europe, first-quarter results demonstrated continued strong commercial execution and sustained physician demand for the SAPIEN platform. The Q1 growth rate also benefited from the exit of a completed year in the prior year. Updated guidelines from the European Society of Cardiology and the European Association for Cardio-Phorotic Surgery are reshaping clinical discussion around proactive disease management. reinforcing the role of TAVR for a broader patient population. Outside of Europe, our self-growth was strong across multiple geographies, including Japan, driven by procedural growth and adoption of our sapient-free ultra-resilient platform. In summary for TAVR, based on our Q1 results, we are raising our full year TAVR self-growth guidance to 7 to 9%. As we look ahead to 27 and beyond, we see compelling mid to high single-digit growth opportunities in TAVR, supported by our patient access strategy, expanding clinical evidence, and a differentiated innovation pipeline designed to meet the needs of millions of patients. around the world that suffer from aortic stenosis. Together, this will have lasting impact on the continued expansion and success of the Sapien platform globally and support a durable multi-year growth opportunity. Now let's turn to TMTT. Our unique portfolio of repair and replacement therapies to treat mitral and tricuspid diseases draws first quarter cells of $173 million, an increase of approximately 42% year-over-year. We believe that mitral and tricuspid procedural growth globally was in the double digits. In tricuspid, we have seen strong adoption of repair and replacement technologies globally. At the recent ACC scientific session, two-year trace and two-data were presented. demonstrating significantly lower all-cause mortality with EVOC versus medical treatment, while accounting for patient crossover. These new data demonstrated that the EVOC replacement system provides significant and sustained elimination of TR, improvements in health status and quality of life, and no added device-related risk. We are also increasing patient access to transcatheter tricuspid valve replacement and driving further adoption of EVOC by expanding into new centers. We believe the growing body of clinical evidence, including reductions in all-cause mortality and house failure hospitalization, will support physicians' continued treatment of patients with tricuspid regurgitation. Moving to Pascal, adoption continues to increase. driven by physician enthusiasm for its unique design and differentiated outcomes and underscored by the significant needs of these patients. Our progress on the Pascal pipeline remains on track with the next generation technology expected in Q4 for both mitral and trachea speed in the US and Europe. We also continue to expect 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 our mitral portfolio in the U.S. Our commercial experience, while early, validates the need for this mitral replacement solution for patients who are not well-suited for mitral tear. Physician feedback on patient outcomes and procedural experience with CPNF3 has been positive. In summary for TMTT, Strong and increasing utilization of our differentiated therapies, EVOC, PASCAL, and CEPIADEM3, combined with double-digit mitral and tracheal procedure volumes globally, positions Edwards for continued growth. Our portfolio of repair and replacement therapies is allowing physicians to select the best possible technical solutions for their patients to get the optimal clinical outcome. This combined with an expanding body of high-quality clinical evidence, expansion into new indication, and the advancement of next-generation technologies support our path towards $2 billion of revenue in 2030 and additional growth beyond. In 2026, we remain on track to achieve $740 to $780 million in sales in TMTT, representing 35 to 45% growth. In surgical, first quarter global sales of $276 million increased 6% over the prior year. driven by continued adoption of our Resilia therapies that offer extended durability. Inspiris adoption continues to increase globally. Connect, which facilitates mental procedures for patients in need, recently launched in Europe with strong adoption. With the launch of Mitris, in additional markets around the world, we have seen strong uptake of this technology in surgical mitral valve replacement procedures. The 10-year data from our commenced trial studying the long-term durability of our best-in-class Resilia tissue will be presented at the upcoming AATS conference. We continue to expect that our surgical tricuspid valve, Triformis, will launch in the second half of the year. Our surgical left atrial appendage closure program is on track for preliminary introduction later this year. In summary, we continue to expect mid single digit cell growth in surgical in 2026. And now, Scott will cover the details of a company's financial performance.