Edwards Lifesciences Corp (EW) — Q3 2022 Earnings Call Transcript

Thank you very much, Diego. And good afternoon, and thank you all for joining us. With me on today's call are Mike Mussallem, Chairman and Chief Executive Officer; and Scott Ullem, Chief Financial Officer. Also joining us for the Q&A portion of the call are Larry Wood, our global leader of TAVR; Bernard Zovighian, our global leader of TMTT; Daveen Chopra, our Global Leader of Surgical Structural Heart; and Katie Szyman, our global leader of Critical Care. Just after the close of regular trading, Edwards Lifesciences 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 Mussallem 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 innovation. We will continue to aggressively pursue breakthrough technologies with the potential to help an even 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 billion to $5.55 billion. We anticipate hospital staffing challenges and a predictively 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 were 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 was 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 digits 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, and 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 remain 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 and 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 billion 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 the growing elderly population supports our expectation that this global TAVR opportunity will reach $10 billion by 2028, which implies a low double-digit compounded annual growth rate. Turning now to our transcatheter mitral and tricuspid therapies product group. Recently, we received U.S. 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 U.S. 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 IID 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 IIF 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 MISCEND study for EVOQUE 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 enrolling the TRISCEND II pivotal trial of the EVOQUE replacement system and the Class IIR pivotal trial with the PASCAL repair system in patients with symptomatic severe tricuspid regurgitation. We no longer anticipate CE Mark approval for EVOQUE 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 the PCR London Valves conference in November, we expect numerous late-breaking data presentations across the TMTT portfolio. Especially noteworthy is new 1-year follow-up data on our early experience with the EVOQUE 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 to bring our 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 are 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 4 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 MITRIS 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 FloTrac and ClearSight sensors with our unique hypotension prediction index algorithm. Additionally, demand for our HemoSphere 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.

Great. Thanks, Mike. As Mike mentioned, our sales of $1.32 billion in the quarter, representing growth of 6.7% on a constant currency basis, fell short of our expectations, driven by a slower-than-expected recovery of U.S. hospital staffing and COVID in Japan. Our strong underlying gross profit margin combined with a minimal spending increase resulted in adjusted earnings per share growth of 13% to $0.61. GAAP EPS was $0.55, which included a net $57 million pretax charge or $0.07 per share related to the HARPOON discontinuation. We anticipate that the U.S. hospital staffing challenge is likely to persist, and we now expect total company sales at the low end of our previous range of $5.35 billion to $5.55 billion. And TAVR sales also at the low end of our previous range of $3.5 billion to $3.7 billion. We continue to expect Surgical Structural Heart sales of $870 million to $950 million, and Critical Care sales of $820 million to $900 million. For the fourth quarter, we're projecting sales and adjusted earnings per share to be similar to Q3. We now expect full year adjusted earnings per share of $2.40 to $2.50, up from 2021 adjusted EPS of $2.22. I'll now cover additional details of our results. Our adjusted gross profit margin in the third quarter was 81.0% compared to 76.3% in the same period last year. This improvement was driven by the expected positive impact from our foreign exchange program, which includes hedge contract gains and natural hedges that offset the negative sales impact from the weakening of the euro and yen against the dollar. At current FX rates, we continue to expect our full year 2022 adjusted gross profit margin to be approximately 80%. This year's forecasted gross margin rate includes approximately 350 basis points of benefit from foreign exchange as compared to 2021. At current rates, FX is expected to result in an approximate 250 basis point reduction in our gross profit and operating margins in 2023. Selling, general and administrative expenses in the third quarter increased 3.5% over the prior year to $377 million or 28.6% of sales primarily due to a resumption of in-person commercial activities, partially offset by the strengthening of the dollar. We continue to expect full year 2022 SG&A expenses as a percent of sales to be between 28% and 30% as we continue to invest in our high-touch model for TAVR and the ongoing build-out of the TMTT commercial team. Research and development expenses in the quarter declined 2% over the prior year to $234 million or 17.7% of sales. The decline reflects unusually high year-ago spending. We continue to expect R&D expenses in 2022 to be between 17% and 18% of sales as we invest in developing our new product pipeline and generating evidence to support TAVR and TMTT. The discontinuation of our surgical HARPOON program resulted in a net $0.07 per share charge consisting of a noncash impairment of intangible assets, a reduction of contingent liabilities and other related exit costs. Additional details of the charge and a reconciliation between our GAAP and adjusted EPS is included with today's release. Turning to taxes. Our reported tax rate this quarter was 15.7% or 17% excluding the impact of special items. This quarter's higher rate reflected a lower benefit from stock-based compensation. We continue to expect our full year tax rate, excluding special items, to be at the high end of our 11% to 15% range. Foreign exchange rates decreased third quarter reported sales growth by 6 percentage points or $74 million compared to the prior year. At current rates, we estimate a year-over-year FX impact to fourth quarter sales of more than $100 million. In total, we now expect an approximate $270 million negative impact or 5 percentage points to full year 2022 sales compared to 2021, and we expect nearly the same negative impact to full year 2023 sales. FX rates positively impacted our third quarter gross profit margin by 440 basis points compared to the prior year. Relative to our July guidance, FX rates had a minimal impact on third quarter earnings per share. Free cash flow for the third quarter was $250 million, defined as cash flow from operating activities of $310 million, less capital spending of $60 million. So before turning the call back over to Mike, I'll finish with an update on our balance sheet and share repurchase activities. We continue to maintain a strong and flexible balance sheet with approximately $1.7 billion in cash, cash equivalents and short-term investments as of September 30. Average shares outstanding during the third quarter were $625 million, down from the prior quarter as we repurchased 1.1 million shares for $100 million. Year-to-date, through the end of Q3, we repurchased 8.4 million shares for $861 million. We expect shares at the end of the year will be slightly below our previous $625 million to $630 million share range. We now have $1.8 billion remaining under our share repurchase program. And with that, I'll pass it back over to Mike.

Thanks, Scott. Well, despite ongoing procedure headwinds associated with the pandemic, we're pleased with our year-to-date performance, which includes strong progress on strategic milestones. We believe hospital staffing constraints will gradually improve and are committed to aggressively investing in our focused innovation strategy for the broad group of patients still suffering from structural heart disease. We remain confident that the innovative therapies resulting from our investments will allow us to treat more patients and continue to drive strong organic growth in the years to come. And with that, I'll turn it back over to Mark.

Thanks a lot, Mike. Before we transition to Q&A, I want to remind everyone that our 2022 investor conference will take place on Thursday, December 8, at the New York Stock Exchange. Thank you to everyone who has confirmed your in-person attendance. We're really looking forward to seeing you soon at this historic venue. In addition to our 2023 financial guidance, you'll hear more about Edwards' focused innovation strategy and our comprehensive and exciting product pipeline. More information will be available on the Investor Relations section of the Edwards website at ir.edwards.com. With that, we're ready to take your questions.

I wanted to ask about 2023, specifically some framework and considerations, and then I have a question for Mike and Scott on tricuspid. Starting with 2023, I think people will look at the implied growth for the second half of the year, which I estimate to be around 7%. This might raise concerns about growth for next year. Mike, could you provide some guidance on how to think about 2023? Are there any catalysts to highlight and P&L considerations we should keep in mind? I noted the FX headwind of 250 basis points, and I’d appreciate any high-level thoughts given the shortfall last quarter and this one. I also have a follow-up.

So Larry, it's Scott. Why don't I start with the financial piece of that and then turn it over to Mike to talk about some of the strategic things that we expect in 2023. Financially, we haven't gotten into the quarter-by-quarter FX impact or growth rates. Typically, we don't give guidance, as you know, for the next year until our investor conference. We'll give you more details then. But just we thought it was helpful because FX has been such an impact this year, and it will continue to fall over the next year that will help quantify what the top line impact will be, which we think is near what is going to be this year. So this year, we're at like 5% of sales and about $270 million. We think maybe it gets near to that at current rates when we forecast for 2023, but we don't have the quarter-by-quarter breakout yet. Mike, do you want to talk about next years...

I will briefly go through the portfolio. We believe that the Surgical and Critical Care sectors are strong and will continue to perform well. We anticipate catalysts from TMTT with the upcoming introduction of PRECISION next year. Although TAVR is currently facing some staffing shortages, we expect those issues to improve gradually. I foresee solid performance ahead. We genuinely believe that there is an opportunity of $10 billion by 2028, and we are confident that we are on track to realize it.

That's helpful, Mike. And actually, I wanted to ask about tricuspid. A lot of excitement around tricuspid. I know you know that you employed a Bayesian design for Class IID. Is it reasonable to assume that you'll employ a similar design for your tricuspid pivotal trials, the two you mentioned? And just how are you thinking about that opportunity? Our check suggested it should be bigger than mitral, maybe somewhere between mitral and aortic.

Yes, thanks, Larry. We are really excited about our pipeline and collaborate closely with regulators globally, including the FDA. Typically, we refrain from commenting on specific details of the regulatory process since they can vary and are context-dependent. Therefore, I won't delve into whether we will conduct a specific upcoming trial. We are fully aware of all available options and will strive to act smartly and in compliance with the regulators, but it remains uncertain. Bernard, do you have anything you would like to add?

Yes. Just a small thing. Obviously, any study, any trial has different designs. Some are comparing devices together, some are comparing a device to medical treatment. So obviously, it is not as easy as taking what we did for IID and applying that to the other studies.

Maybe first, I think it would be helpful. Maybe walk us through some of the differences between why TAVR is so much more impacted than the Surgical business? I know it's lots of similarities but also differences. Is it just pure staffing? Is it the imaging? Is it the testing? Is it the patient pipeline? Any ideas there? And how should we think about the impact from the shortfall in Japan? It looks like numbers came in below the Street by about $15-plus million. Is that all Japan?

Yes. So let me kick it off, Robbie, and then I'll turn to Larry and Daveen to supplement the answer. So actually, the TAVR procedures, we believe, grew faster than the Surgical procedures, if you look at what the market did in the quarter. When you look at Edwards itself, it looks like the Surgical business was growing faster, but that's more Edwards-specific performance rather than what was going on in the underlying market. So I think we have to be a little cautious. Daveen, do you want to add anything from a surgical perspective? And then we'll kick it over to Larry.

Yes, definitely, Mike. Thank you for that. To build on what Mike mentioned, Robbie, the main driver of growth for the Surgical business was the global adoption of the Brazilian portfolio along with the U.S. launch of our new mitral valve, MITRIS, which contributed significantly to our growth. RESILIA and MITRIS were indeed our leading contributors. Additionally, we experienced some market growth, albeit at a low single-digit rate. This trend is observed across surgical operating rooms, which tend to allocate more resources to surgical procedures, particularly within cardiac surgery. This context explains the slow, low single-digit market growth we are witnessing.

Yes, this is Larry. When it comes to TAVR, there is more initial work needed for a TAVR patient compared to a surgical patient. This includes necessary imaging, such as a CT scan for sizing, and often angiograms to check for coronary disease, which are essential for TAVR case planning. Typically, more preparatory work is required for surgical patients. Therefore, if there are staffing issues at any stage in the process, it can result in slower patient progression through the system and a longer recovery time. This is one of the differences we observe. However, as Mike mentioned, procedures grew at a faster rate than surgeries. Many of the factors driving growth in surgeries extend beyond just aortic procedures.

Yes, I want to address Japan briefly. The shortfall we experienced was entirely due to COVID, which had a severe impact there. I'm not sure how much you were aware of its intensity in Japan, but it was significant. Despite that, we are performing well in Japan and will continue to do so. We really felt the effects during the middle of the quarter, but things have started to improve. The wave of cases is subsiding now, and while it was impactful when it hit, it is no longer ongoing.

That's good to know. I have one more follow-up question. The operational expense control this quarter was some of the most significant we've seen since the second and third quarters of 2020 during the peak of COVID. How should we consider where these reductions originated and their sustainability? Additionally, how quickly do you anticipate a recovery going forward?

Yes. Thanks for the question, Robbie. Part of this was operating with a healthy sense of discipline about making sure we're running the company efficiently. But a lot of it was just the benefit of expenses that we incur overseas that translate into lower U.S. dollars.

Maybe my first one is, Mike, for you, specifically on U.S. TAVR. I think that $850 million Q4, what's the underlying implied TAVR? Is that low singles? And I think you mentioned 50% of centers in the U.S. grew double digits. I'm curious, is that a comment just to assure people that this market is still double-digit growing? And perhaps the remaining half of the center, you're seeing some of these staffing challenges. Just give us some context on why we're seeing double-digit growth in some centers and not in perhaps the others?

Yes. I guess we need to check the numbers. I don't know that low single makes sense to me, Vijay. But nonetheless, let's just get into what's there, and I'll turn it over to Larry here in a second. But yes, indeed, we saw a great variance across the country in terms of how hospitals have been performing. And Larry could probably give us some color on that. But we saw some centers that were really growing significantly. We mentioned how many had double-digit growth and other centers that just weren't growing at all. But Larry, why don't you get into that a little bit.

Yes. In our observations across the country, it's clear that staffing challenges are a common topic of discussion. However, these challenges appear to affect some regions more than others. For instance, we've noticed that centers in Texas, which were previously experiencing strong growth, are now facing different dynamics compared to some of our major programs in urban areas with higher population density, where growth has been slower. While there are significant variations, I remain optimistic that as these issues begin to ease, the demand from patients will still be present. Anecdotally, we are hearing that backlogs are continuing to increase, although we are still facing difficulties in resolving the staffing challenges.

Yes. Thanks for the question, Robbie. Part of this was operating with a healthy sense of discipline about making sure we're running the company efficiently. But a lot of it was just the benefit of expenses that we incur overseas that translate into lower U.S. dollars.

I wanted a little more color on the TAVR guidance. It implies $850 million in Q4, which is down sequentially just wanted a better understanding of why down sequentially? And if that's a comment on both U.S. and OUS, you expect kind of both to be down quarter-over-quarter?

I'll start. Part of what we're experiencing is continuing foreign exchange headwinds. And so the $850 million incorporates sales from outside of the U.S. and in the U.S. And outside of the U.S., you've seen the euro and the yen just get weaker and weaker during the course of the year. And so that's part of what's hitting us in the fourth quarter.

Yes. We actually expect more procedures, both in the U.S. and outside the U.S. in the fourth quarter.

I just wanted to come back to a couple of points that you guys made about certain trends related to flu and COVID and then Japan specifically, just to be sure about what's getting better, what's just not getting worse and then what is getting worse into 4Q? And then you keep saying the winter months, it sounds like the early part of '23. So can you clarify what exactly you say, flu and COVID picking up being a tough winter? What regions? I want to make sure I understand where and what's factored into the guidance for that? And the same question on Japan, it sounds like that was getting a little better, you're through the worst of it, but what's assumed in guidance specifically into 4Q? And how should we think beyond that?

There are several questions here, so I will address a few of them. To start with Japan, we believe the situation is improving. The seventh wave has peaked and is declining. Will there be another wave in Japan? It's hard to say. Generally, our insights, particularly from the U.S. and Europe, indicate we expect a challenging COVID and flu season. We haven't fully faced this yet; it's anticipated to peak from November through January. To your question about whether this could impact early 2023, yes, it could. This is based on our global experiences and predictions regarding current variants. I hope this answers your question.

Rich, we assumed it in our guidance. And so there is an appropriate amount of expectation and I guess, conservatism that we are expecting to continue headwinds from respiratory illnesses, whether it's COVID or flu or something in between, we expect that that's going to continue to play a factor in the fourth quarter and into 2023.

I have two quick questions. First, can you provide an update on the enrollment for the moderate AS trial or ALLIANCE trial? I believe I heard that there has been an increase in enrollment pace recently, but could you elaborate on that? Secondly, how should we anticipate the timing of future data from the PASCAL IID study? We received the initial data set at TCT, but when can we expect additional results from that study?

All right. This is Larry. So as it relates to ALLIANCE and PROGRESS, we just really got those trials going this year. And we have seen an acceleration in enrollment, which is really encouraging for us to get these trials moving forward. And given the overall environment, you worry that clinical trials just really add on, and it's a little bit counterintuitive, but our trials are actually starting to enroll at accelerated rates. And so we're very encouraged by that. And I think people are excited about the X4 platform. And I think the moderate AS trial is potentially a groundbreaking trial in terms of how we think about this disease and what is the optimal way to treat it. And I think there's just been a lot of engagement from the physicians to study that in a rigorous randomized trial.

And Adam, your question about additional IID readouts is a good one. So far, this has really been an early readout of the Class IID, which was sufficient to get U.S. approval, but as we follow all of the patients in this trial for the full year, there will be additional data. Bernard, do you want to give us a sense of when that data might be available?

Absolutely. You can expect to see additional data, more patients, more follow-up starting as early as next year.

Okay. Well, thanks, everybody, for your continued interest in Edwards. Scott and the IR team and I certainly welcome any additional questions by telephone. Thanks so much.