Edwards Lifesciences Corporation

Greetings and welcome to the Edwards Life Sciences first quarter 2023 earnings 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 this 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 Wilterding, Senior Vice President Investor Relations, and Treasurer. Thank you. You may begin.

Thank you very much, Diego, and thank you, everyone, for joining us. With me on today's call are Mike Musalem, Chairman and CEO, Scott Ullum, CFO, and Bernard Zavigian, President of Edwards Life Sciences. Also joining us for the Q&A portion of the call are Larry Wood, our Group President of TAVR and Surgical Structural Heart, Devine Chopra, our Global Leader of TMTT, and Katie Zyman, our Global Leader of Critical Care. Just after the close of regular trading, Edwards Life Sciences released first quarter 2023 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 that could cause actual results to differ materially. Information concerning factors that could cause these differences and important 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. Finally, a quick reminder that when using terms constant currency 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?

Thank you, Mark. We're pleased with our first quarter performance, which exceeded our expectations and reflected an improvement in healthcare staffing, along with strong execution of our patient-focused innovation strategy. Sales of $1.46 billion represented 13% growth on a constant currency basis versus a year-ago period. Strong therapy adoption of transcatheter heart valves drove the majority of growth in the first quarter aided by better than expected performance of surgical structural heart and critical care. By geography, strong growth in the US, Europe, and the rest of the world was partially offset by Japan where COVID impacts lingered. First quarter results in the US were also positively impacted in the quarter by some catch up in procedure volumes following a seasonal slowdown late last year. While staffing remains a concern at many sites globally, we're optimistic that the environment will continue to improve. In TAVR, first quarter global sales were $948 million, an increase of 11% year over year on a constant currency basis. We estimate global TAVR procedure growth was comparable with our growth. Local selling prices were stable. In the U.S., Our first quarter TAVR sales grew in the low double digits versus the prior year, and we estimate total procedure growth was comparable. As we indicated, we believe that first quarter trends were lifted by improved hospital staffing levels. Results were also lifted by a catch-up in procedure volumes early in the quarter following the holiday season slowdown. We're optimistic about the early results of our Sapien 3 Ultra Resilia launch in the U.S. As you know, the Resilia tissues anti-calcification technology has demonstrated a strong track record of performance in Edwards surgical valves. Adoptions of this advanced technology is proceeding well, and we expect it to represent the majority of our U.S. TAVR sales before year-end. TAVR growth in the first quarter was driven by larger volume centers, and our sapien valves continue to demonstrate distinguished clinical performance. We're pleased with the continued enrollment of our progress clinical trials studying patients with moderate AS. Related to this, last month at the ACC conference, data were presented that examined mortality rates and cardiac damage of 600,000 early-stage AS patients in the US. This study concluded that all degrees of untreated AS severity were associated with increased mortality risk. Of note, the mean two-year all-cause mortality for moderate AS was approximately 20%, approaching the rate of those with severe AS. Outside the US, in the first quarter, our constant currency TAVR sales grew approximately 10% on a year over year basis. Growth reflected positive contributions from all regions, excluding Japan, which was still impacted by COVID and the recent trialing of competitive products. We expect to see higher OUS growth as international adoption of TAVR therapy remains low. In Japan, although growth was below our expectations, we were encouraged that conditions improved as the quarter progressed and we expect COVID headwinds to diminish substantially over the course of 2023. With the launch of the Sapien 3 Ultra Resilia in Japan late last month, we expect growth rates to improve in this country where aortic stenosis remains significantly undertreated relative to other large developed countries. In Europe, Edward sales growth was driven by the continued strong adoption of our SAPIEN platform and was broad-based across all countries. Total TAVR procedures grew over previous quarters despite persistent disruptions related to hospital staffing shortages. It's encouraging that healthcare systems across Europe are prioritizing life-saving structural heart therapies, including TAVR, amidst these challenges. Looking ahead to the EuroPCR Medical Congress next month in Paris, we anticipate additional data from the Edwards Benchmark Study focusing on strategies to optimize TAVR programs across 28 European centers. Data will also be presented on the outcomes of balloon expandable valves for TAVR in TAVR procedures. In summary, given the strength of our first quarter performance, we now expect constant currency growth of 10% to 12% versus our previous expectation of 9% to 12%. Our outlook assumes that hospital resource constraints continue to improve during the year. We remain confident that this large global opportunity will increase to $10 billion by 2028, which implies a compounded annual growth rate in the low double digits. Turning to TMTT. Our confidence continues to grow in the long-term potential to transform care for the many patients with mitral and tricuspid disease who need better solutions. We remain steadfast in our three key value drivers to unlock this opportunity, developing a portfolio of differentiated therapies for the complex mitral and tricuspid anatomies, driving positive pivotal trial results to support approvals and adoption, and prioritizing favorable real-world clinical outcomes. First quarter sales of $42 million grew substantially, driven by overall tier procedure growth, the ongoing launch and growing adoption of Pascal Precision in Europe, and the initial launch in the United States. We're pleased that we continue to have excellent outcomes for patients, and clinician feedback on Pascal Precision has been consistently positive. particularly highlighting the differentiated premium features of the system. We are ramping production to support the launches of Europe in the U.S. In mitral, we look forward to presenting one-year data from the full quick cohort of class 2D pivotal trial later this year. Meanwhile, we continue to enroll the class 2F pivotal trial with Pascal for patients with functional mitral regurgitation. In mitral replacement, enrollment of the encircled pivotal trial with sapien M3 is ongoing, and we anticipate completing enrollment of the main cohort around the end of 2023. We believe that this replacement therapy will expand options for a broader population of mitral patients. In tricuspid, we've completed enrollment of the TRISEN2 pivotal trial of the Evoque tricuspid valve replacement system and remain on track for European approval by the end of 2023 and in the U.S. around the end of 2024. The FDA recently approved continued access, allowing U.S. hospitals that were involved in the clinical trial to continue to offer Evoque as a therapy option. In addition, the Class II TR pivotal trial with Pascal continues enrolling well. In summary, we're pleased with our continued progress toward bringing a portfolio of therapies combined with contemporary clinical data in order to achieve our vision of transforming the lives of patients with mitral and tricuspid valve disease. We now expect full year 2023 sales of $170 to $200 million versus our previous $160 to $200 million. In surgical structural heart, better than expected first quarter 2023 global sales of $248 million increased a robust 17% on a constant currency basis over the prior year. Growth was driven by penetration of our premium products across all regions and valve surgery growth was higher than our expectations as hospital staffing levels improved, leading to some catch up in procedures. We continue to see strong momentum of the Resilia portfolio globally. Surgeons and patients value the features and benefits of this proprietary tissue technology for both aortic and mitral surgical valve replacement procedures, and we've seen adoption of the mitrous valve in the U.S. increase in the first quarter. The seven-year data from our commence clinical trial will be presented at the annual meeting of the American Association of Thoracic Surgeons next month. We also began enrollment of our momentous clinical trial to demonstrate the durability of Resilia in the mitral position. In summary, based on our first quarter sales, we are raising our full year sales expectation to the high end of our $870 to $970 million guidance range. We now expect high single digit underlying growth in 2023 driven by the adoption of our most advanced technologies and an increase in the overall heart valve surgeries. In critical care, first quarter sales of $222 million increased 9% on a constant currency basis driven by balanced contributions from all product lines. Growth was led by our smart recovery portfolio and strong adoption of our acumen IQ sensor and finger cuff featuring our unique hypotension prediction index algorithm. Demand for our SWAN GANS pulmonary artery catheters and our hemispheres monitoring platform also remained strong in the first quarter with a healthy pipeline of future opportunities. Based on the strong first quarter performance, we now expect critical care full year 2023 sales of $870 to $940 million versus our previous $840 to $940 million. 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 and get patients home to their families faster. And now I'll turn the call over to Scott.