Edwards Lifesciences Corporation

Greetings, ladies and gentlemen, and welcome to the Edwards Life Sciences Corporation second quarter 2021 results. At this time, all participants are in a listen-only mode. A 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. Please note that this conference is being recorded. I will now turn the conference over to our host, Mark Wilterdig, Vice President of Investor Relations. Thank you. You may begin.

Thanks a lot, Diego. Good afternoon, and thank you for joining us. With me on today's call are Mike Musalem, Chairman and Chief Executive Officer, and Scott Ullum, Chief Financial Officer. Just after the close of regular trading, Edwards Life Sciences released second quarter 2021 financial results. During today's call, management will discuss those 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 aren't 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 are made, and Edwards does not undertake any obligation to update them after today. Additionally, the statements involve risks and uncertainties, including but not limited to those associated with the pandemic 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 2020 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, a quick reminder that when using the terms underlying and adjusted, management is referring to non-GAAP financial measures. Otherwise, they're referring to GAAP results. Reconciliations between GAAP and non-GAAP numbers mentioned during the call are included in today's press release. With that, I'd like to turn the call over to Mike for his comments. Mike?

Thanks, Mark. We were encouraged by clear signs of recovery during the second quarter. Vaccine adoption in key regions has contributed to an increasing number of patients seeking, and most importantly, receiving treatment. At Edwards, our dedication of providing innovative solutions for people fighting cardiovascular disease around the world motivates our employees every day. We never stopped our aggressive pursuit of breakthrough technologies with the potential to help an even broader group of patients. Last year, we noted that we're in the midst of the onset of this tragic global pandemic. There were more than 20,000 patients around the world who were treated with our sapien valves in that second quarter. This quarter, more than 30,000 patients were treated with sapien valves, an indication that more patients are benefiting from our life-changing technologies than ever before. Comparisons to 2020 are challenging as last year marked an extraordinary time for structural heart patients, especially during the second quarter when the COVID surge overwhelmed hospitals and undermined regular ongoing care. Patients and their doctors around the world were forced to weigh the risk of COVID versus the severe effects of progressive heart valve disease. Fortunately, we're now experiencing encouraging signs of increased patient confidence to visit their physician. Turning now to our recent results, we're pleased to report better than expected second quarter sales of $1.4 billion, up 44% on a constant currency basis from a year ago period. All four product groups delivered large increases in sales led by TAVR. Total company sales increased sequentially versus Q1. And importantly, sales grew 11% on a two-year compounded annual basis compared to the strong pre-pandemic second quarter of 2019. While hospital heart teams have not been reporting significant backlogs, we believe that procedure rates in Q2 were lifted because patients who previously postponed their doctor visits returned and were treated. We are raising our full year outlook for 2021. We remain cautious about the mixed trends of the recovery from the pandemic. And additionally, we expect a more pronounced summer seasonality associated with a pent-up demand for vacations. Yet, given the better-than-expected year-to-date performance and momentum exiting the quarter, we now expect total sales growth to be in the high teens versus our previous guidance of mid-teens. In TAVR, second quarter global sales were $902 million, up 48% on an underlying basis versus the year-ago period, or 14% on a two-year compounded annual basis. We estimate global TAVR procedure growth was comparable with Edwards growth in the second quarter. Globally, our average selling price remains stable as we continue to exercise price discipline. We continue to be optimistic about the long-term potential of TAVR because of its transformational impact on the many patients suffering from aortic stenosis and because many remain untreated. In a recent article in the American Journal of Cardiology, it reported on the survival of severe AS patients since the introduction of TAVR in 2008. The analysis included clinical data on 4,000 patients obtained at the Mass General and concluded that in the TAVR era, overall survival of patients with severe AS has doubled. The long-term potential, along with the rebound in procedures, reinforces our view that this global TAVR opportunity will exceed $7 billion by 2024, up from more than $5 billion today. And beyond 2024, bolstered by two pivotal trials currently being enrolled, we believe the impact of treating this deadly disease before symptoms and before the disease becomes severe has the potential to transform the lives of even more patients. In the U.S., our TAVR sales grew sequentially over Q1 and over 50% on a year-over-year basis. Our U.S. TAVR volumes were well above pre-COVID levels as our two-year compounded annual growth rate was in the mid-teens. We estimate that our share of procedures was stable. We're encouraged that U.S. TAVR procedures grew as vaccinations increased and patients decided to seek treatment during the quarter. Growth was broad-based across both high and low volume centers. Outside the U.S., in the second quarter, our sales grew approximately 40% on a year-over-year basis, and we estimate that total TAVR procedure growth was comparable. On a two-year compounded annual basis, we estimate that sales grew in the low double digits in the second quarter versus 2019. And although we're encouraged by the strong results, vaccination progress outside the U.S. creates uncertainty for the remainder of the year. Long-term though, we see excellent opportunities for OUS growth as we believe international adoption of TAVR therapy remains quite low. TAVR procedure and Edwards growth in Europe also rebounded significantly on a year-over-year basis. Edwards growth was driven by the continued strong adoption of our Sapien platform and was broad-based across all countries. Patient flow recovered throughout the quarter, although it remained suboptimal in several countries and uncertainty among patients about the urgency of their disease. In Japan, we continue to see strong TAVR adoption driven by Sapien 3 and broad growth across centers of all sizes. We remain focused on expanding the availability of TAVR therapy throughout the country, driven by the fact that aortic stenosis remains an immensely undertreated disease amongst this large elderly population. As previously announced, we received approval earlier in the second quarter for Sapien 3 in patients at low surgical risk, and we continue to anticipate increased treatment rates in Japan when reimbursement is approved in Q3. Now, turning to several recent TAVR clinical trial highlights, last week at the TVT conference, data on the Vancouver's TAVR economic study were presented, which further demonstrated the favorable economic value of our Sapien 3 platform. A comparison of 1,100 patients was conducted to assess the economic impact of next-day discharge. The SAPIEN 3 platform with a minimalist approach achieved better patient outcomes, 30 days post-procedure, and enhanced resource utilization, which resulted in meaningful cost improvements. Also at TBT, results from the Partner 3 bicuspid registry showed similar outcomes to other TAVR patients, as well as significant improvement in patient symptoms and quality of life. We remain as optimistic as ever about the long-term growth opportunity as patients and clinicians increasingly understand the significant benefits of TAVR therapy supported by the substantial body of compelling evidence. In summary, based on the strength that we saw in the second quarter, we have confidence that the underlying TAVR sales will grow around 20% in 2021 versus our previous expectation of 15 to 20% growth. Turning to TMTT, we continue to be very pleased with our clinical outcomes as they remain a key driver to treating many patients in need and unlocking this significant long-term growth opportunity. We continue to be committed to ensuring procedural success and employing a high-touch clinical support model. We are progressing in the enrollment of five pivotal trials across our differentiated portfolio to support therapies for patients suffering from mitral and tricuspid regurgitation. We have initiated use of the PASCAL precision platform and are currently enrolling class trials and early physician feedback has been positive. We remain on track for U.S. approval of PASCAL for patients with DMR late next year. We advanced our clinical experience with transcatheter replacement. as we continued enrollment with our TRICEN2 Pivotal Trial for EVOKE tricuspid replacement. We also continue to treat patients with both our transcatheter mitral replacement therapies through the ENCIRCLE Pivotal Trial for SAPIEN M3 and the MISEN study for EVOKE EOS. As we continue to build a body of compelling clinical evidence, we are pleased with the recent data from several late-breaking presentations across our comprehensive TMTT portfolio. In Mitral, an analysis at EuroPCR of over 2,100 commercially treated patients provided further evidence of the efficacy, safety, and ease of use of the Pascal platform. In addition, two-year results from the CLAS study of Pascal highlighted strong and sustained MR reduction as well as high survival rates for both FMR and DMR patients. And in tricuspid, 30-day outcomes for our TRISEN study for the evoked tricuspid valve replacement system demonstrated favorable technical feasibility and safety, along with significant improvements in tricuspid regurgitation and quality of life for patients. Similarly, outcomes for Pascal tricuspid valve repair resulted in significant TR reduction low complication rates and sustained functional and quality of life improvements at six months. Turning to the financial performance in TMTT, global sales of $22 million was driven by the continued adoption of our Pascal platform as we activated more centers across Europe. We now expect 2021 TMTT sales of $80 to $100 million up from our previous sales guidance of $80 million. We continue to estimate the global TMTT opportunity to triple to approximately $3 billion by 2025, and we are pleased with our progress toward advancing our vision to transform the lives of patients with mitral and tricuspid valve disease. In surgical structural heart, record second quarter global sales of $237 million was up 42% on an underlying basis versus a year ago period. Revenue growth was lifted by increased adoption of our premium Resilia technologies around the world and rebounding surgical aortic treatment rates in the US. We were encouraged by steady improvement in global surgical procedure volumes as we progressed through the quarter. We experienced strong year-over-year adoption of Edwards Resilia tissue valves. including continued adoption of the Inspiris Resilia Aortic Surgical Valve, the Connect Resilia Aortic Tissue Valve Conduit, as well as our new Mitras Resilia Surgical Mitral Valve, which was launched in Japan in the second quarter. We believe the adoption of Resilia Tissue Valves will be further bolstered by the four-year mitral data from our commenced clinical trial presented at the recent meeting of the American Association of Thoracic Surgery, as well as the growing body of Brasilia clinical evidence, which demonstrates excellent durability of this tissue technology, even in the high-pressure mitral position. In summary, given the strength of our year-to-date performance, we are raising our full-year surgical structural heart guidance. We now expect underlying sales growth in the mid-teens versus our previous expectation of high single-digit growth. We continue to believe the current $1.8 billion surgical structural heart market will grow in the mid-single digits through 2026. In critical care, second quarter global sales were $215 million, up 27% on an underlying basis versus the year-ago period. Growth was driven by balanced contributions from all product lines, led by hemisphere sales in the U.S., as hospital capital spending continues to show signs of recovery. Demand for products used in high-risk surgeries remains strong, and demand for the ClearSight noninvasive finger cuff used in elective procedures accelerated following its recovery to pre-COVID levels in the first quarter. InSmart Recovery received FDA clearance for the software algorithm that powers our Hypotension Prediction Index, HPI, on Hemisphere and the Acumen IQ cuff. The non-invasive Acumen IQ cuff provides clinicians with an important new tool to reduce hypotension in a broader range of patients, including those that do not require an arterial line. In summary, given the strength of our year-to-date performance, we're raising our full-year critical care guidance to low double digits versus our previous expectation of high single-digit growth. We remain excited about our pipeline of critical care innovations as we continue to shift our focus to smart recovery technologies designed to help clinicians make better decisions for their patients. And now I'll turn the call over to Scott.