Edwards Lifesciences Corporation

Greetings and welcome to the Edwards Life Sciences fourth quarter 2023 earnings conference call. 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. Investor Relations, and Treasurer. Thank you. You may begin.

Thank you very much, Diego, and good afternoon, everyone. Thank you all 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 Larry Wood, our 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 fourth quarter 2023 financial results. During today's call, management will discuss those results included in the press release and accompanying financial statements 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 2022 annual report on Form 10-K, 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 constant currency sales growth, which is defined in the quarterly press release issued earlier today. Reconciliations between GAAP and non-GAAP numbers mentioned during the 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, Mark, and welcome, everyone. At our recent investor conference, I introduced our exciting vision of a new era of structural heart innovation to address significant unmet patient needs. Today, I will build on that theme and share key highlights of our team's strong performance in 2023, as well as our confidence in 2024. We are pleased with our strong 2023 financial performance. with full-year sales up 12% to $6 billion, including strong growth across each of our four product groups. We invested more than $1 billion in research and development, and we achieved key strategic milestones, including the introduction of new technologies and indication expansion to ensure sustainable, healthy growth in the near, mid, and long term. We exited the year with strong momentum with Q4 growth of 13% and TAVR growth of 12%. These results were better than expected, driven by a broad portfolio of innovative therapies. In 2024, we are well positioned to enter a new era of structural heart innovation. In TAVR, we are strengthening our leadership. We are experiencing strong adoption of our flagship Sapien 3 Ultra Resilia and continuing enrollment in our alliance pivotal trial for our next-gen TAVR technology, Sapien X4. In January, we achieved a very important milestone with the completion of enrollment 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. This randomized trial enrolled approximately 750 patients two years ahead of schedule. At TCT later this year, we plan to present data from Early TAVR, a pivotal trial studying the treatment of patients with severe aortic stenosis but without symptoms. We believe that all of these initiatives position us for healthy, sustainable tether growth well into the future. In TNTT, we achieved significant milestones with continued Pascal global expansion and the introduction of Evoke in Europe. In Germany, Evoke was recently granted NUB reimbursement status one, a very important step in therapy adoption. I am also pleased to announce that EVOC recently became the first trans-catheter therapy to receive USFD approval for the treatment of TR patients. This is an exciting development for a wide range of US patients. It will enable access to a groundbreaking treatment option that not only has the potential to significantly improve their quality of life, but also shows favorable clinical trends in all-cause mortality, re-intervention, and heart failure hospitalization. With the ongoing introduction of EVOC, we are now offering a unique and broad portfolio of trans-catheter repair and replacement solutions for mitral and tracheal patients. In addition, the completion of enrollment in the pivotal trials studying sapien M3 put us on track to further enhance our portfolio. I am confident that we are reaching an inflection point as the only company with a commercially approved portfolio of catheter-based technologies to treat the millions of patients suffering from mitral and tracheal disease. In addition to the meaningful progress of TAVR and TMTT, we are pleased with the company innovative Resilia tissue, which was pioneered by our surgical business. We are on track to treat half a million patients with Resilia-based heart valve by the end of 2024, supported by seven years of clinical evidence. The previously announced spin-off of critical care is progressing as planned and will enable a sharpened focus on structural heart. As a result, EDWARDS 2025 organic cells growth rate will be even more distinguished. In addition, this will give us more agility, increase our pace of innovation, and provide an expanded opportunity to serve a large and growing patient population. Because we are solely focused on structural heart disease, we are uniquely positioned to deliver sustainable growth and extend our leadership. Now I will provide some additional detail by product group. In TAVR, our full year 2023 global sales of 3.9 billion increased 10.6% year over year. our U.S. and all U.S. sales growth rates were similar. In the fourth quarter, our global TAVR sales of 979 million increased 12% year-over-year. Performance was driven by double-digit growth in the U.S., Europe, and Japan. The company's competitive position was stable globally, and local selling prices were also stable. In the U.S., We remain pleased with the continued expansion and adoption of a sapien-free ultra-resilient platform. This technology builds on Edouard's longstanding leadership in tissue technology and durability by combining advancements in tissue science with the industry-leading sapien-free ultravalve. Developing safe, effective, and durable heart valve requires significant long-term commitment, and we are proud to build on 65 years on Valve innovation while leveraging the expertise and know-how of more than 2,000 engineers and R&D specialists across the company. We are proud of uninterrupted leadership in structural art and will continue to invest vigorously in these platforms. In addition, Our scaling of patient activation initiatives along with next-gen TAVR and additional evidence on asymptomatic and moderate AS patients position us for healthy, sustainable TAVR growth well into the future. Outside of the U.S., in the fourth quarter, our double-digit growth was comparable with our global TAVR growth, driven by Europe and Japan. Long-term, we continue to anticipate excellent opportunities for growth, as international adoption of TAVR therapy remain quite low in many regions. In Europe, EDWARDS Sales Growth was driven by the broad-based adoption of our CPIN platform. It is encouraging that the growth in Q4 was widespread across all major countries. Looking ahead, we are pleased with the recently announced CMARC approval for sapien-free ultraresilia, and we are planning for a discipline launch. We were pleased with our sales growth in Japan, and as expected, we grew faster than overall procedural growth. After more than 20 years of rigorous clinical experience, and over one million patients treated with sapien vaccine around the world, our TAVR platform is positioned for continued global leadership and strong sustainable growth. Given the under-treatment rates, we are confident in the future of TAVR, driven by greater awareness, patient activation, a platform that delivers life and management for AS patients, advances in new technologies such as Resilia, as well as indication expansion and increased global adoption. Turning to TMTT now, in 2023, We remain focused on our key value drivers to unlock the significant long-term opportunity for patients, a portfolio of differentiated therapies, positive clinical trial results to support approvals and adoption, and favorable real-world clinical outcomes. Based on the deep learnings we have achieved from our clinical trial and real-world experiences, we have carefully constructed a strategic portfolio of leading transcatheter technologies to provide both repair and replacement solutions for mitral and tracheal patients. Pascal Precision, Evoque, and Sapien M3 will provide best-in-class therapies to treat the broadest range of patients. Full year, global sales of 198 million increased 67% versus the prior year. TMTT fourth quarter cells of 56 million increased 71% versus the prior year. Q4 cells were driven by the accelerating adoption of our differentiated Pascal precision platform and activation of more centers across the US and Europe. We were encouraged by the ongoing double digit growth of overall trans-catheter edge-to-edge repair procedure, which highlights the large unmet patient need. We continue to expand global access of Pascal Precision in new countries, including Japan, where we recently completed our first cases. Since launch, we have proudly treated more than 20,000 patients around the globe with Pascal repair system. In mitral replacement, we have received FDA approval for a sapien-free continued access program. Physicians are continuing to treat patients with this novel therapy. In tricuspid replacement, we initiated the launch of EVOC in Europe with a focus on outstanding outcomes and the goal of eliminating tricuspid regurgitation in patients. And in the U.S., following the recent early FDA approval, we are initiating the introduction of this novel therapy and building the foundation for long-term expansion. As we did for TAVR, we are focusing on best-in-class physician training, generating more evidence, and achieving excellent patient outcomes. We are grateful for the strong ongoing collaboration with clinicians all over the world to provide the treatment options to many patients suffering from tracheal speed valve disease. In tracheal speed repair, the class two-tier pivotal trial with Pascal continues to enroll well and remains on track to complete enrollment by the end of this year. As a summary for TMTT, we are reaching an inflection point with the only portfolio of approved catheter-based mitral and tracheal speed technologies. We remain committed to bringing our differentiated therapy to patients with this life-threatening disease and believe our strategy positions us well for leadership. In our surgical product group, Full-year global sales of $999 million increased 13% versus the prior year. Fourth-quarter global sales of $248 million increased 10%. Growth was driven by strong global adoption of Edwards Premium Resilient Technology and overall procedural volumes. We are confident about the future of this tissue technology and its role in improving patient lifetime management. We continue to see positive momentum in our innovation globally with continued adoption for patients best treated surgically, including those with complex and concomitant procedures. We continue to expand the overall body of Resilia evidence, including ongoing patient enrollment of our momentous clinical study. We received C-mark approval of our Mitral 3D evolved in the fourth quarter and have begun to launch in several European countries with favorable physician feedback. Turning to critical care, full year global sales of 928 million increased 10% versus the prior year. Fourth quarter, critical care sales of 250 million increased 11%. Growth was driven by contribution from all product line, led by Hemosphere and Smart Recovery, with strong adoption of our Acumen IQ sensor equipped with the Hypotension Prediction Index algorithm. Critical care strategies to drive 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. And with that, I will turn the call over to Scott.