Edwards Lifesciences Corporation

Good afternoon and welcome to the Edwards Life Sciences third quarter 2022 results conference call. At this time all participants are in a listen only mode. A question and answer session will follow the 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 Wilterding, Senior Vice President, Investor Relations and Treasurer. Thank you. You may begin.

Thank you very much, Diego. And good afternoon, and thank you all for joining us. With me on today's call are Mike Musalem, Chairman and Chief Executive Officer, and Scott Ullum, Chief Financial Officer. Also joining us for the Q&A portion of the call are Larry Wood, our Global Leader of TAVR, Bernard Zavegian, our Global Leader of TMTT, Devine Chopra, 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 third quarter 2022 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 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 2021 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, underlying, and adjusted, management is referring to non-GAAP financial measures. Otherwise, they are referring to GAAP results. Reconciliations between GAAP and non-GAAP numbers mentioned during the call are included in today's press release. And with that, I'd like to turn the call over to Mike Massalem for his comments. Mike?

Thanks, Mark. The third quarter strengthened our conviction in our company's patient-focused innovation strategy. Globally, structural heart procedures grew less than we expected in the third quarter, but that didn't slow us down, as our team accomplished numerous important milestones and made good progress on our multiple clinical trials and next-generation technologies. In August, we received European regulatory approval for Pascal Precision. This unique system is designed for transcatheter-based edge-to-edge leaflet repair in patients suffering from mitral and tricuspid regurgitation. Shortly thereafter, in September, we received early U.S. FDA approval for Pascal Precision for the treatment of patients with degenerative mitral regurgitation which was welcome news for clinicians who appreciate this differentiated platform. And in TAVR, last month we announced approval to begin selling the Sapien 3 Ultra Resilia Valve in the U.S. Our industry-leading Sapien 3 Ultra Transcatheter Aortic Heart Valve now incorporates Edwards Breakthrough Resilia technology. Additionally, during the third quarter, enrollment accelerated in our two TAVR pivotal trials, progress evaluating patients with moderate AS, and alliance for our next generation TAVR technology, Sapien X4. These transformative developments reinforce our confidence in the continued growth of transcatheter-based structural heart interventions. We will continue to aggressively pursue breakthrough technologies with the potential to help even a broader group of patients and in turn drive significant future value. Now, turning to our financial performance, third quarter total company sales of $1.3 billion increased 7% on a constant currency basis versus the year-ago period. Our broad portfolio of innovative technologies drove this growth, although it was at the lower end of our expectations, reflecting persistent U.S. hospital staffing shortages and COVID headwinds in Japan. Adjusted EPS grew 13%, even while aggressively investing in R&D and commercial infrastructure to support new therapies. For full year 2022, we expect total Edwards sales will be negatively impacted by foreign exchange and be at the low end of our previous range of $5.35 to $5.55 billion dollars. We anticipate hospital staffing challenges and a predicted difficult winter COVID and flu season will continue into next year. In TAVR, third quarter global sales of $862 million increased 6% on a constant currency basis. Sales were below our expectations due primarily to the persistent U.S. hospital staffing shortages and COVID headwinds in Japan, which intensified the typical impact of summer seasonality. In the third quarter, we're pleased that well over 30,000 patients were treated with Sapien across our more than 2,000 global TAVR centers. We estimate that global TAVR procedure growth was comparable with Edwards growth in the third quarter. Local selling prices were stable, although the average global selling price declined due to the weakening euro and yen. In the U.S., our TAVR procedures increased in the mid single digits versus the prior year. We estimate that our share of procedures was stable. As expected, our third quarter U.S. TAVR procedure volumes continued to be impacted by regional U.S. staffing constraints, which were somewhat worse than we anticipated. There were a high level of variability in growth rates across centers around the country. And while staffing issues limited overall growth during the quarter, nearly half of our TAVR centers grew double digit in Q3. Outside the U.S., in the third quarter, our TAVR sales grew in the low double digits on a constant currency basis, and we estimate total procedure growth was comparable. Our underlying three-year compounded annual growth rate outside the U.S. remains in the mid teens. In Q3, Geographies outside of Europe and Japan grew even faster in the quarter. Long term, we see excellent opportunities for OUS growth as we believe international adoption of TAVR remains quite low. In Europe, sales were down sequentially as expected. Even though we compete with a broad range of competitors, our competitive position remains stable. Scattered staffing shortages, slightly exacerbated summer seasonality. We anticipate some lingering regional impact on that. In Japan, third quarter procedure growth was impacted by a widespread seventh wave of COVID, which created a significant strain on hospital capacity and limited TAVR procedure volumes. As you might expect, procedure volumes in Q3 varied across the country, as patients and the providers were incentivized to turn their focus again to the treatment of patients with COVID. We saw TAVR procedure volumes improve as COVID hospitalizations decreased late in the third quarter. We remained focused on expanding the availability of TAVR therapy driven by the fact that AS remains a significantly undertreated disease amongst this large elderly population. In summary, We anticipate the continuation of staffing shortages in a difficult winter COVID and flu season. We expect Q4 TAVR sales to be around $850 million and full year 2022 TAVR sales to be at the low end of our previous range of $3.5 to $3.7 billion. We remain confident about the long-term potential of TAVR as the rapidly evolving evidence recognized by policymakers around the world supports continued adoption of this therapy for the many patients suffering from aortic stenosis. This broad-based, favorable evidence, combined with the undertreatment rate and growing elderly population, supports our expectation that this global TAVR opportunity will reach $10 billion by 2020-age, which implies a low double-digit compounded annual growth rate. Turning now to our transcatheter mitral and tricuspid therapies product group. Recently, we received US FDA and European CE mark approval of Pascal Precision. This next generation system designed to facilitate precise navigation and an intuitive user experience will enable us to initiate our commercial presence in the US for the treatment of patients suffering from degenerative mitral regurgitation and also expand Pascal adoption in Europe for both mitral and tricuspid patients. This exciting news was followed by the presentation of first results from the class 2D pivotal trial at the recent TCT conference. This first-of-a-kind head-to-head randomized pivotal trial further established the safety and efficacy of mitral transcatheter edge-to-edge repair. We were pleased that this data demonstrated that Pascal is a beneficial therapy expanding transcatheter treatment options for DMR patients. In addition, we continue to advance enrollment of our class 2F pivotal trial for patients with functional mitral regurgitation. Separately, we continue to treat patients with our two transcatheter mitral replacement therapies through the ENCIRCLE pivotal trial for sapien M3 and the MYCEN study for EVOKE-EOS. We are pleased with our progress and believe these sub-30 French transfemoral therapies will help transform treatment for patients and expand the mitral opportunity. Turning to tricuspid, we continue to make progress in rolling the TRISEN-2 pivotal trial of the EVOC replacement system and the CLASP-2R pivotal trial with the Pascal repair system in patients with symptomatic severe tricuspid regurgitation. We no longer anticipate CE mark approval for evoke tricuspid replacement in Europe this year. As uncertainties remain around the MDR process, we now expect a CE mark approval late in 2023 with sales contribution in 2024 when we expect to have reimbursement in place. We're excited about this therapy for the many tricuspid patients who have few treatment options today. Looking ahead to PCR London Valves Conference in November, we expect numerous late-breaking data presentations across the TMTT portfolio. Especially noteworthy is new one-year follow-up data on our early experience with the Evoke tricuspid valve. We expect these presentations to contribute positively to the growing body of compelling clinical evidence for our comprehensive portfolio of transcatheter mitral and tricuspid therapies. Turning to the sales performance of TMTT, third quarter sales of $30 million grew sequentially from the second quarter despite summer seasonality. Adoption of the PASCAL system in Europe increased as we initiated a limited introduction of PASCAL precision. And we continue to have excellent outcomes for patients as we progress on a gradual expansion into more centers in Europe. We forecast to increase the number of procedures in Q4, yet expect reported Q4 sales to be similar to Q3 as a result of FX headwinds and a spike in COVID in Germany, our largest region in Europe. 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. In surgical structural heart, third quarter global sales of $220 million increased 8% on a constant currency basis over the prior year. We were encouraged to see strong global growth driven by increased penetration of our premium Resilia products despite staffing challenges in certain regions. And although staffing shortages continue to be a concern, we're observing that cardiac surgeries are being prioritized. We continue to see strong momentum of the Resilia portfolio globally as we bolster the overall body of evidence, including four abstracts recently presented at the European Association for Cardiothoracic Surgery annual meeting in Milan. We continue to believe that physicians value the features and benefits of this advanced tissue technology for both aortic and mitral surgical valve replacement procedures. Adoption of the Mitras valve launched in the U.S. in April, now represents the majority of our mitral valve sales in this region. Separately, we've decided to exit our Harpoon surgical mitral repair system and stop enrollment in the related clinical trials. Given our experience to date, we made the difficult decision to focus on developing other innovative therapies to better serve patients and continue to be the partner of choice for cardiac surgeons. In summary, we remain confident that our full year 2022 underlying sales growth will be in the mid-single digit range for surgical structural heart driven by market adoption of our newest premium technologies and surgical market growth. In critical care, third quarter sales of $207 million increased 3% on a constant currency basis over the prior year. The growth rate was impacted by a very strong prior year comparison. Sales growth was driven by increased adoption of our broad portfolio of smart recovery products, including flow track and clear sight sensors with our unique hypotension prediction index algorithm. Additionally, demand for our hemisphere monitoring platform remains strong. In summary, we continue to expect mid single digit underlying sales growth for the full year 2022. We remain enthusiastic about our pipeline of critical care innovations highlighted by smart recovery technologies designed to help clinicians make even more informed decisions for patients. And now I'll turn the call over to Scott.