Edwards Lifesciences Corporation

Greetings and welcome to the Edwards Life Sciences first quarter 2024 results. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should 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 your host, Mark Wilterding, Senior Vice President, investor relations. Thank you. You may begin.

Thanks a lot, Diego. And good afternoon, and thank you all for joining us. With me on today's call is our CEO, Bernard Zavigian, and our CFO, Scott Allum. Also joining us for the Q&A portion of the call will be Larry Wood, our global group president of TAVR and Surgical Structural Heart, Devine Chopra, our global leader of TMTT, Wayne Markowitz, our global leader of Surgical Structural Heart, and Katie Zyman, our global leader of Critical Care. Just after the close of regular trading Edwards Life Sciences released first quarter twenty twenty four financial results. During today's call management will discuss these 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 include but are not limited to financial guidance and expectations for longer term growth opportunities regulatory approvals clinical trials litigation reimbursement, competitive matters, and foreign currency fluctuations. 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 and important product safety information may be found in the press release, our 2023 annual report on Form 10-K, and Edwards' other SEC filings, all of which are available on the company's website at edwards.com. Finally, unless otherwise noted, our commentary on sales growth refers to constant currency sales growth, which is defined in the quarterly press release issued earlier today. Reconciliations between GAAP and non-GAAP numbers mentioned during this call are also included in today's press release. With that, I'd like to turn the call over to Bernard for his comments. Bernard?

Thank you, Marc. We are pleased with our total company performance with first quarter sales growth of 10% to 1.6 billion versus the year-ago period. As a result, we are raising our 2024 sales guidance to the high end of 8% to 10%. As we look ahead, I'd like to share some perspective about the strategic direction of our company. Edwards is well-positioned to extend our leadership and deliver sustainable growth, driven by the strategic investments we have made across our trans-catheter platforms to address the large and growing needs of patients impacted by aortic, mitral, and tricuspid disease. We remain confident in the many opportunities to grow TAVR over the long term. In addition, TMTT is becoming an increasingly significant contributor to EDWARDS growth and we expect this will continue. An important element in our valve innovation leadership is our advanced tissue technology. We have been an innovator in tissue technology for more than 50 years, and we are pleased with our latest technology, Resilia. With differentiated evidence of advanced durability, this technology is used across our comprehensive valve portfolio with a focus on lifetime management of the patients we serve. We are pleased that half a million patients will benefit from this tissue technology by the end of 2024. As the global leader in structural heart, we remain deeply committed to bringing the highest quality evidence, groundbreaking technology, and world-class physician support to advance science and meaningfully improve patient care. This year, we are already making significant progress on multiple clinical trials and next-gen technologies. In January, we achieved an important milestone with the completion of patient treatment in progress, a pivotal trial studying the treatment of moderate aortic stenosis patients a population estimated to be twice as large as severe aortic stenosis. In February, EVOC became the first transcatheter therapy to receive US FDA approval for the treatment of patients with tricuspid regurgitation. EVOC is a groundbreaking treatment option that not only has the potential to improve quality of life, but also shown favorable clinical trends in all-cause mortality, re-intervention, and heart failure hospitalization. In March, at the annual CRT conference, we announced compelling results from two large real-world studies demonstrating continued excellent outcomes for patients treated with the Edward Sapien Valve platform. And earlier this month at the American College of Cardiology Conference, we announced data from the HUDL study. Initiated by Edwards in 2021 with our partner at NFL Alumni Health, the study examined the prevalence of structural heart disease among groups historically known to experience disparities in access to care. Edwards is committed to helping identify and dismantle barriers to access for communities that are underserved due to race, gender, and socioeconomic status. Each of these reflect our deep commitment to advancing patient care through our differentiated strategy and reinforce our confidence in sustaining the growth of trans-catheter-based structural heart intervention. Now I will provide some additional detail on Q1 results by product group. In TAVR, first quarter global sales of $1 billion increased 8% year-over-year when adjusted for billing days. Q1 marked the first quarter that Edward's TAVR sales exceeded $1 billion, an exciting milestone for our team and a testament to clinicians' confidence in our leading technology. Performance was driven by growth in the U.S. and Japan, Edward's global competitive position and selling prices were both stable. In the U.S., our year-over-year first quarter Tether sales growth rate was higher than our global constant currency growth rate. We estimate total procedure growth was comparable. Procedure volumes increased as the quarter progressed. We remain pleased with the continued performance of our best-in-class TAVR platform, Sapien 3 Ultra Resilia, which builds on Edward's longstanding leadership in tissue technology and durability. This innovative technology now makes up the majority of our cells in the U.S. This platform is supported by the robust real-world data from more than 10,000 patients in the TVT registry that demonstrated excellent outcomes across hundreds of centers, The technology's optimized tissue treatment is designed to extend durability of a valve, a feature that will be increasingly important as the therapy continues to treat patients with longer life expectancy. We are also proud to continue our deep commitment to advancing science for AS patients through the progress and early TAVR trials. As discussed in January, We completed enrollment and treatment of patients in progress, approximately two years ahead of expectation. We also expect to release the result of early TAVR at the TCT conference this year. Symptom assessment is one of the most significant barriers to referral, and the early TAVR trial evaluates the impact of TAVR on asymptomatic patients with severe AS. We believe If data are compelling, early TAVR may have a meaningful impact on deciding when to treat patients, while also streamlining referral and patient care for all severe AS patients. Outside of the US, in the first quarter, our constant currency TAVR sales growth was slightly below our global TAVR growth. Strong growth in Japan and the rest of the world was partially offset by slower than expected growth in Europe. In Europe, our results were softer than expected in Q1, but we expect full year 2024 performance to normalize. We are actively preparing for the launch of Sapiens 3 Ultra Resilia in Europe, and we anticipate introducing the technology into the European market in Q2. In Japan, We continue to see strong TAVR adoption driven by sapient-free ultra-resilient. We believe AS remains a significantly under-treated disease among the substantial elderly population and continue to focus on expanding the availability of evidence supporting this therapy. In closing, we are confident that Edwards is positioned for healthy and sustainable TAVR growth well into the future, driven by our development of differentiated TAVR technology, our deep commitment to advancing patient care through high-quality clinical evidence, and our investment in patient activation initiatives. Importantly, we are proud of our groundbreaking research into the treatment of AS through our early TAVR and progress trial, which could fundamentally change how AS patients are treated. We remain confident in our full-year TAVR sales growth of 8% to 10%. We expect higher year-over-year second-half growth rate than in the first and second quarters. Turning to TMTT, we drove positive momentum with our unique and broad portfolio strategy for both repair and replacement therapies, for mitral and tricuspid patients. We made significant progress in advancing important technologies, including the Pascal-Wheeler system, the Evoke tricuspid replacement system, and the Sapien M3 mitral replacement system. We are the only company with multiple approved mitral and tricuspid therapies backed by world-class evidence to improve patient care. In Q1, we achieved positive results. with sales of 73 million, representing a 72% increase versus the prior year. The majority of our Q1 sales were driven by expanded adoption and new site activation of Pascal, supported by continued double-digit tier market growth in the US and Europe. We are also pleased with strong physician feedback and excellent procedural outcome with the evoke tricuspid valve in both the U.S. and Europe. With this replacement technology, we see the unique elimination of tricuspid regurgitation, significant quality of life improvement for patients, and favorable trend in all-cause mortality and heart failure hospitalization. The increasing physician demand for EVOC is a clear indication of an unmet need and the potential for this therapy to treat a very large patient population. We continue to invest in expanding our high-touch field organization globally to support this therapy in order to continue to achieve excellent outcome for each patient. Given the strong adoption of our differentiated technology, PASCAL and EVOC, we are raising full-year TMTT guidance to 320 to 340 million versus previous guidance, which was the higher end of 280 to 320 million range. We are confident that our unique portfolio strategy with repair and replacement options for both mitral and trachea speed will offer clinicians the broad set of therapies necessary to effectively treat many patients in need. This strategy position us for global leadership sustainable long-term growth, and an increasing contribution to overall EDWARDS growth. In surgical, first quarter sales of $266 million increased 8% over the prior year. Growth was driven by strong global adoption of EDWARDS premium surgical technologies in Spiris, Mitris, and Connect. We continue to see positive procedure growth globally for the many patients best treated surgically, including for those undergoing complex procedures. We continue to expand the overall body of evidence in multiple technologies and multiple valves and now expect U.S. and Canada enrollment of our momentous clinical trial studying Resilia performance in the mitral position to be completed in Q2 2024, one year ahead of expectation. The study will continue to open new sites in Europe and Latin America with global enrollment continuing into 2025. We are now raising our full year surgical self-guidance to six to eight percent versus previous expectation of mid single digit growth. In critical care, Variability of demand led to better than expected first quarter sales of $251 million, which increased 14% versus the prior year, driven by contribution from all product lines. Growth was led by our smart recovery technologies, including the Acumen IQ sensor. Demand was also strong for our Swangan's catheter and pressure monitoring devices used in the ICU. Critical care remains focused on driving growth through smart recovery and smart expansion, which are designed to help clinicians make more informed decisions and get patients home to their family faster. We are now confident in raising our full-year critical self-guidance to 8% to 10% versus previous expectations of mid-single-digit growth. Since announcing the spin-off of Critical Care in December, our team has made significant progress, and I want to thank all of them for their hard work and dedication. Scott will provide additional details. And now, I will turn the call over to Scott.