Edwards Lifesciences Corporation

Greetings and welcome to the Edwards Life Sciences first quarter 2025 results. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If you require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce you to your host, Mark Wilterding, Senior Vice President, Global Finance. Thank you, Mark. You may begin.

Thanks, Alicia, and thank you, everyone, for joining us this afternoon. 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 Larry Wood, our Global Group President of TAVR, and Surgical, Devine Chopra, our Global Leader of TMTT, and Wayne Markowitz, our Global Leader of Surgical. Just after the close of regular trading, Edwards Life Sciences released first quarter 2025 financial results. During today's call, management will discuss those results included in the press release and accompanying financial schedules and then use the remainder of 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 were 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. Information concerning 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. Edwards' guidance reflects its current estimates of the impact from tariffs that are in effect or has 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 new tariffs could have a material impact on the company's future financial results and guidance. Unless otherwise noted, our commentary on sales growth refers to constant currency sales growth, which is defined in the quarterly results press release issued earlier today. Reconciliations between GAAP and non-GAAP numbers mentioned during this call are also included in today's press release. Quarterly and full-year growth rates refer to continuing operations and do not include discontinued operations. With that, I'd like to turn the call over to Bernard for his comments.

Thank you, Mark. Welcome, everyone. Please, have confidence. Total company sales grew 8%. to $1.41 billion in the first quarter, reflecting the benefits of our broad and differentiated portfolio of therapies to treat patients with structural heart disease. The many milestones achieved in Q1 are the result of our 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. I'd like to thank our 16,000 global employees for their many contributions to advancing patient care. Tether growth in the quarter was better than expected, as clinicians continued to adopt our best-in-class sapient technology. Looking ahead to the rest of the year, we continue to believe that the results of the early TAVR trial represent a multi-year growth opportunity that will begin with the expected indication approval in the second quarter and expand with the evolution of policy and guideline changes in the US and globally. And in late 2026, we look forward to the presentation of the results of a groundbreaking progress trial, which has the potential to further expand the therapy to many new patients with moderate AS. I am proud of our commitment to TAVR innovation and high-quality science that is increasing access to treatment options for all AS patients. We continue to be pleased with TMTT's strong momentum, reflecting our portfolio of differentiated repair and replacement technologies, and we are raising our 2025 TMTT self-guidance range to $530 to $550 million. As a reminder, our successful TMTT strategy positioned us to become the first to develop and launch a transcatheter tricuspid valve with EVOC in 2024. Today, I am also very proud of the recent approval of our Sapien M3 in Europe, the world's first transcatheter mitral valve replacement system, which will benefit many patients with mitral regurgitation who have limited treatment options. This breakthrough technology demonstrates our team's long-term and steadfast commitment to solving large, unmet patient needs. Edwards, with Evoque, M4E, and Pascal, is uniquely positioned to meet the broad and diverse needs of patients with tricuspid and mitral valve diseases. In surgical, our category-leading business continues to benefit from increasing adoption of our premium Resilia portfolio in Spiris, Mitris, and connect. Edwards continues to invest in surgical innovation and evidence as we expand access to our therapies globally. Last week, at the Heart Valve Society meeting, eight-year data were presented demonstrating the excellent durability of a company's novel Resilia tissue, which is used in a wide range of Edwards surgical platforms as well as sapient-free ultra-Resilia. The results represent the longest follow-up study on the durability of valves, which highlights our dedication to pioneering unique innovation. With patients of all ages living longer and seeking higher quality of life, the importance of lifetime management has never been greater. We also continue to make steady progress, advancing our portfolio of emerging opportunities, which we discussed at our investor conference in December. Our team continues to build capabilities to reach the millions of patients around the world who suffer from structural heart failure. And in aortic regurgitation, we are enrolling patients in Journey, the pivotal trial for the Edwards J-Valve ER system. Turning to our 2025 financial outlook, we are confident in our full-year total company sales growth guidance of 8% to 10%, And we have plans in place to offset the estimated impact of a currently announced tariff and the estimated dilution from the Yena valve acquisition, which we are planning to close mid-year. As a result of our plans, we are in a position to deliver on our original EPS guidance of 2.40 to 2.50 cents. Our priorities continue to be serving the patients who count on us and maintaining the highest level of service and support to our physician partners around the world. Looking ahead to 2026 and beyond, Edwards is positioned to transform care for the many structural heart patients in need. We are confident that our strategic focus, unique innovation strategy, and exceptional work of our employees around the world will deliver significant value to patients the healthcare ecosystem and shareholders. Now I will provide some additional detail by product group for Q1. In TAVR, our first quarter global sales of $1.05 billion increased 5.4% over the prior year, or 6.5% when adjusted for billing days, which was a little higher than expected. growth was comparable in the US and all US. It was strong competitive position and pricing remained stable globally with some regional variability. I am proud of our team's commitment to leading with science, supported by a decade of clinical research that set the standard for quality evidence and physician decision making. This significant body of high quality science from rigorous FDA trials underscores the excellent clinical outcomes delivered by EDWAR's premium sapient technology. Last month, at the American College of Cardiology conference, new clinical data from the early TAVR trials studying patients with asymptomatic severe AS were released. The data highlighted that delayed aortic valve replacement in this patient population was associated with worse outcomes. Additionally, a new study using cardiac biomarkers revealed that the rapid and unpredictable progression of the disease. Both studies underscore the need for urgent referrals for treatment, evaluation for severe AS patients, regardless of symptoms. Also at ACC, new groundbreaking data from the DETECT-AS study were presented. DETECT-AS is the first randomized trial evaluating the impact of physician notification, or echo alerts, for their patients with severe AS that meet treatment guidelines. The study found that these echo alerts increase both treatment and survival rate for patients with severe AS. In the US, our leading sapien-free ultra-resilient platform continues to demonstrate strong performance. We are advancing initiatives to help hospitals treat structural heart patients efficiently and manage increasing procedure volumes. We are encouraged by hospitals that have demonstrated the ability to scale to accommodate procedure growth. We are encouraged by discussion with key clinicians on the long-term impact of early TAVR data. to streamline patient care. In addition, we expect asymptomatic indication approval in the second quarter. Outside of the US, we continue to focus on the value of our 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 was supported by the continued expansion of Sapien3 Ultra Resilia in Europe. Sapien3 Ultra Resilia continues to deliver exceptional clinical outcomes, reinforcing the differentiation of this best-in-class platform. In Japan, we continue to face a weaker procedure growth environment and competitive pressure. We remain dedicated to addressing the significant under-treatment of AS among the substantial elderly population in Japan. In summary for TAVR, we are maintaining our full year sales growth guidance of 5 to 7%. Long term, we are enthusiastic about the durable mid to high single digit growth opportunity in TAVR, supported by the upcoming early TAVR indication approval, guideline and policy changes, and the potential to serve patients with moderate AS. Turning to TMTT, our unique and increasingly differentiated portfolio draws another quarter of impressive growth with a meaningful contribution to overall company performance. We are pleased with first quarter sales of $150 million representing growth of about 60% and led by increased adoption and balanced contribution from PASCAL and EVOC in the US, Europe, and globally. We continue to see strong therapy adoption and expansion across both mitral and tricuspid. Globally, mitral tear procedures continue to grow double digits, and the developing tricuspid opportunity is growing even faster across both repair and replacement. 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 EVOC commercial launch is progressing well in the US and Europe, with continuing excellent patient outcomes. At the end of March, We were pleased to see the finalization of the NCD for trans-catheter tricuspid valve replacement for patients suffering from tricuspid disease. With the new NCD, EVOC is now covered for all Medicare beneficiaries who meet the criteria outlined in the final coverage policy, expanding patient access to this important therapy. We are pleased with the recent approval of the CPNM3 mitral valve replacement system in Europe. This revolutionary transketeter bias therapy is built on the proven SAPIEN platform, which has been used in more than 8,000 procedures in the mitral position. We continue to expect that results from the in-circle pivotal trial, studying M3, will be presented at the TCT conference in October 2025. As part of our deep commitment to advancing science for patients with structural heart disease, a European post-market follow-up study is planned to continue evaluation of sapien M3, following patients out to five years. As previously shared, we expect US approval of sapien M3 to follow in 2026. The launch plan for sapien M3 in Europe is focused on creating a new category as we have done many times before, and achieving excellent patient outcomes. With our decades of experience, we are uniquely positioned to bring Sapien M3 to the many patients in need across Europe. We will work with all stakeholders to ensure patient access to this novel therapy, providing physician training, and working with policymakers to establish proper therapy coverage. Edwards is the only company that offers a trans-catheter portfolio that includes both replacement and repair treatment options for both the mitral and tracheal valves, meeting the complex needs of underserved patients. We are committed to bringing this portfolio to patients in need around the world and expect meaningful impact from these advanced therapies in 26 and beyond. In our surgical product group, First-quarter global sales of $251 million increased 3% over the prior year. We continue to see positive procedure growth globally for the mini-patient, best treated with Edwards' premium Resilia portfolio, including Mitris, Inspiris, and Connect. We continue to generate high-quality evidence on our Resilia tissue technology. As shown in the eight-year data presented at the recent Heart Valve Society meeting, Resilia tissue valves had significantly improved freedom from structural valve deterioration and freedom from re-operation compared to non-Resilia valves. Also in the quarter, our surgical team made progress advancing important innovation around the world. Mitris launched in China with positive surgeon feedback. And we anticipate receiving CMR approval for the Connect Aortic Valve Conduit in Europe before year-end. And now, Scott will cover the detail of the company's financial performance.