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spk10: Greetings and welcome to the Edwards Life Sciences third quarter 2021 results call. 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. Vice President of Investor Relations and Treasurer. Thank you. You may begin.
spk01: Thank you very much, Diego. 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. Just after the close of regular trading, Edwards Life Sciences released third 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 of 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 can 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?
spk08: Thanks, Mark. Let me begin by expressing appreciation for our global teams who have been highly engaged throughout the pandemic. We're also pleased that our supply chain remained resilient during these challenging times to meet the needs of the patients we serve. Turning to results, third quarter total company sales of $1.3 billion increased 14% on a constant currency basis versus the year-ago period. Strong mid-teens growth was driven by our innovative platforms, although lower than our July expectations, due to the significant impact COVID had on US hospitals. Although we experienced encouraging signs of patient confidence and continued willingness to seek medical care in July, the Delta variant had a significant impact on hospital resources during the last two months of the third quarter, especially in the US. Despite the pronounced impact of the Delta variant in the U.S., in Q3, we're encouraged by the recent decline in hospital COVID admissions. We believe some procedures were unfortunately deferred in the third quarter. And based on what we saw in Q2, we expect many of these patients who deferred treatment in Q3 will be treated in the future. We continue to expect total company sales growth to be in the high teens for the full year. In TAVR, third quarter global sales were $558 million, up 14% on an underlying basis versus the year ago period. We estimate global TAVR procedure growth was comparable with our growth in the third quarter. Globally, our average selling price remains stable. In the U.S., our TAVR sales grew 12% on a year-over-year basis, and we estimate that our share of procedures was stable. Growth was broad-based across both high and low volume centers. As you might expect, procedure volumes in Q3 were affected by seasonality and varied by geography and even by hospital as patients and providers turned their focus again to the pandemic. Our TAVR sales in July benefited from encouraging signs of continued recovery from the pandemic However, procedures were negatively impacted in the last two months of Q3 due to the significant impact Delta had on hospital resources. Outside the U.S., in the third quarter, our sales grew approximately 20% on a year-over-year basis, and we estimate total TAVR procedure growth was comparable. We continue to be encouraged by strong international adoption of TAVR broadly in all regions. And despite the impact of Delta, the TAVR market in Europe showed relative resilience with strong growth in procedure volumes. Growth was broad-based across Europe and driven by continued strong adoption of our Sapien 3 Ultra platform. We were pleased with the growth rate, considering that in Q3 of 2020, centers in Europe had already recovered from pandemic lows. Longer term, we see excellent opportunities for continued OUS growth as we believe global adoption of TAVR therapy remains quite low. It's worth noting that recently published guidelines from the European Association of Cardiothoracic Surgery now definitively recommend TAVR for patients over the age of 75. The acknowledgement by the Surgical Society that TAVR is preferred for those over 75 is a significant development. We believe these guidelines represent an important long-term opportunity, and although transcatheter valves have been commercially available for over a decade in Europe, it remains clear that there is still a large unmet need for this therapy. Strong TAVR adoption continued in Q3 in Japan. As expected, we received reimbursement approval in Q3 for treatment of patients at low surgical risk. We remain focused on expanding the availability of TAVR therapy throughout this country, driven by the fact that AS remains a significantly under-treated disease amongst this large elderly population. At the upcoming TCT meeting, there's a planned late-breaking update on the economic outcomes of partner three at two years. In summary, Based on October procedure trends, we expect Q4 growth for TAVR to be similar to Q3. We continue to expect underlying TAVR sales growth of around 20% in 2021. We remain as confident as ever 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. The long-term potential reinforces our view that this global TAVR opportunity will exceed $7 billion by 2024, which implies a low double digit compound annual growth rate. Now turning to TMTT, we've made meaningful progress across all our platforms with over 6,000 patients treated to date. To transform treatment and unlock this significant long-term growth opportunity, we remain focused on three key value drivers, a portfolio of differentiated therapies, positive pivotal trial results to support approvals and adoption, and favorable real-world clinical outcomes. This quarter, we've progressed on the enrollment of five pivotal trials across our portfolio to support therapies for patients suffering from mitral and tricuspid regurgitation. We are gaining experience with the Pascal precision platform as part of our class trials and physician feedback continues to be positive. We look forward to presenting randomized data from the class 2D pivotal trial next year and remain on track for the U.S. approval of Pascal for patients with DMR late next year. This important milestone will mark a transition from large single arm studies to significant pivotal trial results that support approval and adoption and will be the first of several key data sets from our CLASP trials. We continue to treat patients with both of our transcatheter mitral replacement therapies through the ENCIRCLE pivotal trial for sapien M3 and the MISEN study. of Evoke EOS. We are ramping up enrollment with our novel Evoke Tricuspid Replacement Therapy as part of the TRICEN2 Pivotal Trial. These promising transfemoral therapies are critical for many patients without treatment options today and exemplify the importance of a comprehensive portfolio. As we continue to expand our body of clinical evidence, we look forward to presenting meaningful data at TCT and PCR London valves next month. Presentations will include six-month outcomes of evoked tricuspid replacement from our clinical trial experience in the TRISEN study. In addition, 30-day outcomes for mitral repair with Pascal from our MyCLASP post-market clinical follow-up study of over 250 patients. We also anticipate several live case demonstrations of our differentiated therapies. Turning to the financial performance in TMTT, despite the impact of Delta and summer seasonality, global sales of $22 million were driven by the continued adoption of Pascal in Europe. As we expanded commercially, we continue to experience high procedural success rates and excellent clinical outcomes for patients and we remain committed to employing our high touch clinical support model. We're pleased with our level of site activation during the quarter. We continue to expect to achieve our previous full year guidance of 80 to $100 million and estimate the global TMTT opportunity to triple to approximately $3 billion by 2025. And we're pleased with our progress toward advancing our vision to transform the lives of patients with mitral and tricuspid valve disease. In surgical structural heart, third quarter global sales were $217 million, up 6% on an underlying basis versus the year ago period. Despite the Q3 resurgence in COVID cases, we're encouraged to see continued SAVR procedure growth across most regions. We remain encouraged by the steady global adoption of Edwards Resilia tissue valves, including the Inspiris Resilia aortic valve, the Connect Resilia valve conduit, and our Mitris Resilia mitral valve. This advanced tissue treatment is increasingly supported by a growing body of real-world evidence as demonstrated at the European Association of Cardiac Thoracic Surgeons annual meeting earlier this year. Registry data confirmed excellent real-world outcomes with Inspiris Resilia in patients under the age of 60. As patients increase their awareness of surgical valve choices, we believe that they're learning about the durability potential of Resilia and engaging with their physicians to choose this technology. In summary, we have confidence that our full-year 2021 underlying sales growth will be in the mid teens for surgical structural heart driven by market growth and adoption of our premium technologies. We continue to believe the surgical structural heart market that we serve will grow mid single digits through 2026. In critical care, third quarter global sales were $213 million, up 17% on an underlying basis versus the year ago period. Growth was driven by contributions from all product lines, led primarily by strong hemisphere capital sales in the U.S. Our TruWave disposable pressure monitoring devices used in the ICU remained in demand due to the elevated hospitalizations in the U.S., and demand for products used in high-risk surgery also grew year over year, in addition to demand for the ClearSight noninvasive finger cuff used in elective procedures. In summary, we continue to believe that critical care will grow revenue in the low double digit range in 2021. 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.
spk04: Thanks, Mike. Today, I'll provide additional perspective on the third quarter. along with how we anticipate the rest of the year may unfold, and some color on what to expect at the investor conference on December 8th. Total sales in the third quarter grew 14% on an underlying basis over the prior year. As indicated earlier, this strong sales growth is lower than we expected in July before the U.S. Delta surge. Earnings in the quarter of 54 cents met our expectations, as COVID-related constrained spending more than offset lower than expected sales. As Mike mentioned, based on the improving trends with the Delta variant and our October procedure trends, we are projecting total Q4 sales of between $1.30 billion and $1.38 billion. As it relates to each product line, we are forecasting fourth quarter TAVR sales of $850 million to $910 million, and still have the potential to reach underlying TAVR sales growth of around 20% for the full year 2021. We are also maintaining our previous ranges for TMTT, surgical structural heart, and critical care. We continue to expect our full year adjusted earnings per share guidance at the high end of $2.07 to $2.27 with fourth quarter adjusted EPS of 53 to 59 cents. And now I'll cover additional details of our third quarter results. Our adjusted gross profit margin was 76.3%, up from 75.5% in the same period last year when we experienced substantial costs responding to COVID. The improvement was also driven by a more profitable product mix, partially offset by a negative impact from foreign exchange. Like most companies, We are seeing signs of inflation generally in things like some of the raw materials we use in production, as well as shipping and logistics. With that said, some of the extraordinary costs we incurred when COVID hit last year have lessened, and the net result is no material impact to our gross profit margin performance or guidance for 2021. More broadly, we are continuing our investments to ensure that our supply chain is strong and resilient and capable of delivering life-saving products for our patients. We continue to expect our 2021 adjusted gross profit margin to be between 76 and 77%. Selling, general, and administrative expenses in the third quarter were $364 million, or 27.8% of sales, compared to $307 million in the prior year. This increase was primarily driven by personnel-related costs, and increased commercial activities compared to the COVID-impacted prior year. We are planning a sequential ramp-up of expenses in the fourth quarter as COVID-related restrictions continue to subside. We still expect full-year 2021 SG&A expenses as a percentage of sales, excluding special items, to be 28% to 29%. Research and development expenses in the quarter grew 22% over the prior year, to $238 million, or 18.2% of sales. This increase was primarily the result of continued investments in our transcatheter innovations, including increased clinical trial activity. We are planning to increase these expenses in the fourth quarter as we invest in developing new technologies and generating evidence to expand indications for TAVR and TMTT. For the full year 2021, we continue to expect R&D expenses as a percentage of sales to be 17 to 18%. Turning to taxes, our reported tax rate this quarter was 13%, or 13.9%, excluding the impact of special items. This rate included a 320 basis point benefit from the accounting for stock-based compensation. We continue to expect our full year rate in 2021, excluding special items, to be between 11 and 15%, including an estimated benefit of 4 percentage points from stock-based compensation accounting. Foreign exchange rates increased third quarter reported sales growth by 70 basis points, or $8 million, compared to the prior year. At current rates, we continue to expect an approximate $70 million positive impact, or about 1.5%, to full-year 2021 sales compared to 2020. Foreign exchange rates negatively impacted our third quarter gross profit margin by 30 basis points compared to the prior year. And relative to our July guidance, FX rates positively impacted our third quarter earnings per share by less than a penny. Free cash flow for the third quarter was $471 million, defined as cash flow from operating activities of $532 million less capital spending of $61 million. Our year-to-date free cash flow is $1.1 billion. The strong cash flows are a reflection of our exceptional portfolio of patient-focused technologies that are generating returns from previous investments, which allows us to fund future internal and external opportunities. We continue to maintain a strong and flexible balance sheet with approximately $3 billion in cash and investments as of September 30th. Average shares outstanding during the third quarter were 632 million, and we continue to expect our average diluted shares outstanding for 2021 to be at the lower end of our 630 to 635 million guidance range. We have approximately $1.2 billion remaining under the share or purchase program. Before turning the call back over to Mike, I'll make a quick comment about our outlook for 2022. It's premature to offer detailed guidance today, but we will provide 2022 financial guidance at our investor conference on December 8th. In general, in 2022, we're planning on less disruption from COVID as we assume the resumption of more normalized sales and earnings growth. We will provide guidance for gross profit and operating margins, as well as more visibility into any potential impact from changes in corporate tax rates. And with that, I'll pass it back to Mike.
spk08: Thanks, Scott. So we are very pleased with our strong year-to-date performance despite the headwinds associated with the pandemic. You know, and as patients and clinicians increasingly choose transcatheter valve therapy, we remain optimistic about the long-term growth opportunity. We are committed to aggressively investing in our focused innovation strategy because we believe there's a broad group of patients still suffering from structural heart disease and the pandemic's impact will wane. We remain confident that the innovative therapies resulting from our investments will continue to drive strong organic growth in the years to come. And with that, I'll turn it back over to Mark.
spk01: Hey, thanks a lot, Mike. And as you heard from Scott earlier, our 2021 Investor Conference will take place on Wednesday, December 8th, here at our headquarters in Irvine, California. For those of you able to join us on campus, the conference will be hosted with appropriate safety precautions. And there will also be available via webcast. Either way, we really hope you can be a part of it. In addition to our 2022 financial guidance, you'll hear more about Edwards' focused innovation strategy and our comprehensive and exciting product pipeline. For more information, please visit the investor relations section of the Edwards website at ir.edwards.com. So with that, we're ready to take your questions. As a reminder, please limit the number of questions to one plus one follow-up to allow for broad participation. If you have additional questions, please re-enter the queue and management will answer as many participants as possible during the remainder of the call. Diego?
spk10: Thank you. And if you'd like to ask a question at this time, simply press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press the star key followed by the number 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from Vijay Kumar with Evercore ISI. Please state your question.
spk15: Hey, guys. Thanks for taking my question. Maybe for the first one, Mike, or Scott, perhaps, the Q4 guidance here, what is the underlying assumptions here in terms of any further disruptions from... you know, future waves, or perhaps even the flu season, where it might be perhaps hard to differentiate respiratory symptoms between the traditional flu versus COVID. So some commentary on Q4 assumptions will be helpful.
spk08: Yeah, thanks, Vijay. Yeah, like so many others, we really struggle with precisely projecting the pandemic. You know, Edwards Business is strong. All the fundamentals are in a great place, and we know that there are many patients with structural heart disease in particular that are in need and so we feel great about it from that perspective but the the pandemic uh ends up having impact on hospitals and their ability to be able to handle the the volumes and we find it very spotty uh it's it's regional in nature and you know the good news is we're watching the delta variant come down in the u.s and that's where we felt most of the impact and so That's very good. Of course, there is concern of will there be some kind of a winter surge that is not apparent at this point. So those things are always possible. We have, by and large, modeled the fact that we think things are going to get gradually better. We have taken into account where we are in October. In October, we saw run rates that were similar to what we saw in the last couple of months of Q3. And so that has also gone into our thinking. So I don't know if that answers your question, BJ.
spk15: No, that's helpful, Mike. And just on the last comment around hospital capacity to any volumes, I guess, you know, labor shortage has been spoken about. You know, on the one hand, you know, when I think about the limited number of TAVR centers and this issue of labor shortages, you know, it feels like you know, handing backlog or excess cases might be a challenge. But on the flip side, Mike, you know, conscious sedation where, you know, patients are in and out pretty quickly, these are highly profitable procedures. So should we perhaps be making a case for, you know, hospitals to incentivize perhaps to drive volumes? I'm curious how you balance those two.
spk08: Yeah. No, it's a great point, Vijay. And, you know, it is one of the pluses that's associated with TAVR, that often there isn't an ICU stay. But when we watch what happens with various hospitals, and sometimes whether it's for staffing reasons or just the fact that they're swamped with COVID patients, they'll just put up the stop sign and decide that they're just not going to do procedures. And, you know, whether they're elective or resource consuming or not, Well, we're probably more impacted by the ICU capability, but it's not always the case. Sometimes it's just broadly across the hospital. So I don't have one answer for all because it tends to be a little bit more snowflakes with each hospital being a bit different, but hopefully it provides you with a little bit of color.
spk15: Understood. Thanks, guys.
spk10: Our next question comes from Bob Hopkins with Bank of America. Please say your question.
spk16: Okay, thanks, and good afternoon. Mike, I realize it's a challenging time to make forecasts, and so I won't ask you about forecasts. I'm just – what I'm curious about and would love your views on is just, you know, what we know now. Like, what are you seeing out there now? How much better is the environment than it was a month ago? You know, just kind of curious to see your kind of – your net views on – and I'm asking specifically from a TAVR perspective – kind of how much improvement you've seen. Where are we right now relative to where we were just a few months ago? Thank you.
spk08: Yeah. Thanks, Bob. It's a really good question. You'll probably stay close to our team that watch daily sales each day and adjust their own feelings based on how things change almost on a daily basis. And, you know, things, you know, it gets tough, and I hate to get too granular, but things are a little better today than they were even earlier in the month. But I hate to get too granular on that, Bob. In general, we tried to give you some information to let you know that October was not so dissimilar than the end of Q3. So we didn't want to send a signal that all of a sudden October is back to the kind of thing that we were experiencing in Q2. So we're not experiencing that kind of an environment yet. But we're overall optimistic. I mean, we talk to a lot of folks anecdotally. Obviously, the trends that I mentioned of Delta improving is something we think is going to pay off. We think often that maybe TAVR is a bit of a trailing indicator of what's happening with COVID, that the cases ultimately turn into ICU stays, and it probably affects our caseload a little bit later. But that's a bit speculative on our part. Okay, no, thank you for that.
spk04: Bob, it's Scott. I'll just echo something that Mike said, which is, you know, if you just roll forward what things have been trending like in October, the growth rate for Q4 and TAVR looks a lot like it did for Q3, which is, call it 14%. So, like Mike said, it's moving around. We're watching it carefully and trying not to overreact or underreact to what the daily sales trends looks like, but If you had to call it right now, that's sort of what the trend looks like. And then for the full year, it gets you to something near the 20% underlying growth rate that we've talked about for all of 2021. Okay.
spk16: Thank you, Scott. That's very helpful. And then last quick question is just on the U.S. trial for Pascal and when we'll see those data, is there a set time for that yet or just sometime early in 2022?
spk08: Yeah, we don't have clarity on when the timing for that will be. We say it will be next year. We're sticking with our date and our belief that we will have approval by the end of next year, but we really don't have clarity on when it's going to be presented. That will be one that we hopefully will have a little bit more visibility when we get to the investor conference, Bob, and try and give you a sense for it at that time.
spk16: Thanks very much.
spk10: Thank you. Our next question comes from Robbie Marcus with JP Morgan. Please set your question.
spk11: Oh, great. Thanks for taking the questions. First one for me, you know, earlier this year we saw some competitive data that, you know, maybe looked a little more competitive with SAPIEN 3. I know it's still early days and the European numbers look good this quarter, but are you starting to see any shift in trends or reception to some of the newer valves in Europe recently?
spk08: The short answer is no. It's been very similar feeling that we've had throughout the year that was the case in the past. We continue to think that the top two competitors make up about 85% of the sales in Europe and all the rest, which is a full complement of competitors, make up the other 15%. So we really haven't seen any significant shifts in that, if that's helpful.
spk11: Yeah, it is. And maybe one for Scott. You know, this was another quarter where we saw the financial leverage potential of the business increase. You know, where do you think, you talked about spending more in fourth quarter, but where do you think we are maybe from a gross margin and operating expense perspective versus, you know, a no COVID environment? So maybe said another way, if you fast forward and there's no more COVID, you know, does gross margin have room to improve from here and, you know, maybe how much impaired is the SG&A and R&D versus what you would like to spend in an unrestrained environment? Thanks.
spk04: Yeah, so we do think gross margin has room to improve from here, as does operating margin. Keep in mind, we're already starting from relatively strong margins compared to our industry. So our priority has been investing aggressively on internal growth more so than on trying to expand margins. But I do think there's going to be opportunity for those margins to gradually incrementally slowly expand over time and it's something that we that we try to think carefully about short term though to your question about covid you know it's been remarkable our our margins have remained pretty stable despite the fact that sales are down relative relative to pre-covered levels because expenses are down as well largely driven by things that are happening out in the field so travel meetings, attendance at various different societies and events. And so it's been kind of a natural hedge against the sales headwinds that we've seen from COVID and we're benefiting from that. To be honest though, we'd like to see expenses go back up along with sales because it's an indication that the environment is more normalized, that we're able to invest aggressively, that we can enroll our clinical trials. at the higher rates that we saw pre-COVID. And so that's sort of the way we're thinking about margins overall.
spk11: Great.
spk04: Thanks for taking the question.
spk10: Our next question comes from Josh Jennings with Cowan. Please go ahead with your question.
spk02: Hi. Good evening. Thanks so much for taking the questions. I wanted to start, Mike, I was hoping to just learn a little bit about your updated thoughts on the backlog that you mentioned in the second quarter earnings call. assume with just the environment that that's peeled back a little bit. But one, just any kind of review of the referral channels and patients coming off the sideline in 3Q, and should investors be thinking that that 2Q phenomenon could reemerge in 2022 as we move through this COVID surge?
spk08: Yeah, thanks, Josh. You're on a key point, and we do talk about it quite a bit inside. We don't have perfect visibility and perfect data, so much of what we rely on are anecdotal reports. We spend a lot of time with our customers and frontline clinical specialists to try and gain some kind of perspective. It's tough for us to nail the timing and magnitude of this, but clearly we feel like we got a small lift in Q2 from patients that came into the system that had probably deferred care. If we reflect back on the total pandemic, when things first stopped back in 2020, back in the March-April timeframe, it's difficult for us to say that we saw those patients come back into the system. But differently, it felt like the last winter's patients did indeed have So at least some of those, some small quantity showed up and supplemented Q2. So that's not a giant number, but it's additive. And we speculate the similar kind of thing might happen as a result of the patients that have deferred care during the Delta variant. You know, during the Delta variant, you know, and we're speculating again, we may indeed have had these patients that actually saw their physician and and got diagnosed, but that the actual treaters in regional hotspots weren't there to provide the therapy. So we think there's some reason why this might come back. Exactly when it might come back is very difficult, but as COVID wanes, we're hoping that indeed we see a similar phenomenon as we saw in Q2.
spk02: Thanks for that. And then just one follow-up. And we get a lot of questions just on low-risk penetration. I think the TBT registry update was presented a couple weeks ago. And I think for 2020, the update was about 28% of patients received TAVR were low-risk. That seems pretty low. It seems like we're still in early innings of low-risk penetration. We just would love to get your thoughts in terms of where the TAVR market is in terms of penetrating that low-risk opportunity. Thanks a lot.
spk08: Thanks, Josh. I wish I could tell you the problem was low risk. We think there's an under-treatment problem across all the risk spectrums, whether it's high risk, intermediate risk, or low risk for surgery. I think early innings is a good way to characterize it. We still think that there are many patients that should be receiving therapy that don't. It's for a variety of reasons. In many cases, they're just not aware of the option of TAVR being available for them and being appropriate for them. And so it's a key initiative for us. We've been making progress, but the progress has been slow and steady, and we're not close. I don't know if I would put tremendous stock in that penetration number. In general, we think penetration rates across the border are even worse than that, yeah.
spk10: Thanks again. Thank you. Our next question comes from Matt Mixitch with Credit Suisse. Please state your question.
spk03: Hi. Thanks so much for taking the question. So just one on Europe and overseas TAVR, and then one follow-up, if I could, just on sort of general market trends. You know, the European or overseas numbers – seem to be, you know, I guess less sequentially impacted than the U.S. And I'm just, you know, there's been an awful lot of focus on staffing and challenges around the U.S., obviously the surge, but, you know, do you see, I'm curious if you see staffing in other regions being as much of an issue it is in the U.S. and whether you can sort of tease out the areas of strength that drove what was pretty good, you know, Q3 performance outside the U.S., despite the surge and everything that went on, and I have just one follow-up.
spk08: Yeah, thanks, Matt. No, your observation was correct. We saw far more impact in the U.S. than we saw in Europe. Our colleagues in Europe, by comparison, were pretty healthy growth rates, and you'll notice in my comment that if you go back to Q3 of last year, it's not as though Europe was really doing poorly. They actually had a growth quarter versus 2019. I think I want to say high single-digit growth or something last year. So this is growth on top of that growth, which is pretty significant considering this therapy was introduced in Europe back in 2007. So it's pretty mature, and here we are still growing even during a pandemic. So for whatever reason, the Delta variant didn't seem to impact the European centers the same way it did in the U.S.,
spk03: That's great. Um, and then if I could, I know Scott, you had, uh, laid out some, some basic sort of bullet points of what we can expect at the, at the analyst meeting and investor moving in December. But, you know, in, in past years, there's, there's one thing that seems to have come up year over year, which is, you know, great growth in, in say a given year for TAVR. And then sort of, uh, the issue of comps becomes kind of a conversation for the following year. Uh, And I guess, you know, one of the things heading into 22, and I think you mentioned decreasing impact of COVID or something like that and back to sort of normalized growth. I'd just be curious to hear whether you expect comps to be, you know, potentially a little bit less of the conversation, you know, when you sort of frame out your expectations to start 22, given the way this year has played out.
spk04: Well, you know, I guess by definition, the comps are important just as we think about growth rates. But it sort of ties back to Vijay's question earlier on about, you know, when do we start seeing COVID more in the rearview mirror and less in the windshield? And to the extent that that lessens, you know, as we get to the end of the fourth quarter, beginning of the first quarter, for example, then prospects for 2022 growth are going to be higher. If COVID is playing a more meaningful role in certain regions or there are hotspots that are more noticeable, then that's going to impact our growth overall. That's probably the biggest uncertainty that we have going into 2022, because overall, we feel really positive about the growth prospects for TAVR in the US and Europe and Japan and in the rest of the world. You know, one of the things that we were talking about earlier with this low risk penetration, while it's difficult to calculate the actual penetration, Remember the timing on low risk where we have the data for low risk with partner three at ACC in 2019. We got approval in the third quarter of 2019. And shortly thereafter, COVID became a factor and interrupted our growth for TAVR. And so we haven't really had this period that's uninterrupted from COVID for any extent of time since we got the low risk approval. And it's one of the reasons why we think they're just great growth opportunities longer term for TAVR.
spk03: That's helpful color. Thank you, Scott.
spk10: Our next question comes from Danielle Antalfi with SVD Lyric. Please state your question.
spk12: Hey, good afternoon, everyone. Thanks so much for taking the question. I had a question on Pascal shifting to Nitro now. And I was just wondering, Mike, if you could talk a little bit about the U.S. launch strategy. I know it's early, but you guys launched a premium price in Europe. Curious about whether that's the plan for the U.S., if you can disclose that, and if it is, sort of what we need to see from the data set that's going to be presented next year.
spk08: Yeah, well, thanks. Yeah, no, as we indicated, we're looking forward to having Pascal approved, and again, it would be approved for DMR by the end of 22 in our views. We're already... taking some of the initial steps to build some capabilities. And we'll assemble a dedicated field team, and we'll be implementing our high-touch model. And really, we're going to focus on just getting excellent real-world outcomes. We're going to take advantage of all the learnings that we've had from launching TAVR around the globe and launching TMTT in Europe. In general, we do consider Pascal a premium therapy. It would also implement our premium pricing plan. That would be consistent with what we've done elsewhere in the world. So hopefully that gives you a little color on how we'd approach this.
spk12: Yeah, no, that's very helpful. And then the follow-up question I have is as far as, you know, sort of target centers initially. I mean, is the plan to target existing TAVR centers and sort of leverage your TAVR, you or will you go specifically to Mitral Center? Sort of how do we think about the initial target center? Thanks so much.
spk08: Yeah, thanks, Danielle. It's a little early to say, you know, this is going to be an interesting evolution. In some cases, the same people that do TAVR might do Mitral cases, and others, there's dedicated teams. It's a little too early for us to say. We're going to get into it. We'll have more to talk about when we're together at the investor conference, but Right now, I really don't have any specific color for you.
spk12: Understood. Thanks.
spk10: Thank you. And our next question comes from Cecilia Furlong with Morgan Stanley. Please go ahead with your question.
spk00: Great. Thank you for taking the question. I wanted to ask Mike about Japan and what you've seen just throughout this year in terms of the centers over there that are certified to perform TAVR, how that's trended. And then as you think about low-risk reimbursement, kind of the outlook given the landscape of TAVR centers kind of near term and then flowing into 2022 as well.
spk08: Yeah, thanks. So we were very pleased to get the low-risk reimbursement approval. That happened mid-quarter, I want to say, sometime in the August timeframe. The There are indeed new centers that get added. Those get added on a pretty deliberate basis. And those new centers tend to be kind of slow to ramp up. There are significant regulatory requirements that are necessary to fire up new centers. But having said that, it's a dramatically undertreated disease in Japan. They have a very large elderly population. And when we think about it in terms of, for example, TAVR per million, we say, boy, there's still a long way to go. So we're very pleased with the growth rate. The growth rate in Japan was even higher than our international growth. And the reimbursement is important. It's an important key. It's exciting to be able to get that. And hopefully that begins helping Japanese clinicians redefine the importance of TAVR for their patients. And I think, you know, we've got to take it for granted that low risk is already present in other places around the world, and it just hasn't been in Japan until this last quarter.
spk00: Okay, great. And I wanted to ask as well just what you're seeing on the clinical enrollment landscape given COVID and if you could provide any updates either on early TAVR or X4 and when you expect to kind of ramp enrollment there. Thank you.
spk08: Yeah, thanks. Yeah, you might recall, Cecilia, that early on we said that there was impact on our trial enrollments. We're not experiencing that the same way during this flare-up of Delta. It doesn't make it easier, but hospitals have done a nice job of adjusting and adapt. They have very committed teams. And so whether it's our trials in TAVR or our trials in TMTT, It feels like we've done well. We basically feel that our trials timing have not been impacted by this latest surge.
spk10: Thank you. And our next question comes from Larry Beagleson with Wells Fargo. Please go ahead with your question.
spk17: Okay, good afternoon, guys. Thanks for taking the question. Just one for me on Pascal. Mike, in Europe, it looks like your share has kind of been inching up. And by our math, you've reached about 20% share in Europe after about three years. So my question is, you know, what gets you higher? I know that your goal is to be market leader. So do you need the RCT data? And how are physicians using Pascal in Europe? Are they mostly using it for DMR? Or are they, you know, using it for both DMR and FMR? I believe the label is broad. So, you know, kind of what gets your share? What do you think you need you know, to get that share up. Thanks for taking the question.
spk08: Yeah, thanks, Larry. And, you know, as you might imagine, it's difficult to estimate shares. But, frankly, we haven't really gone into this thinking that that's our focus. Our focus has been to get outstanding clinical results. And we focus on that both within our trials and within our commercial experience. And that's what we've pushed our team. And when you ask me, okay, what's it going to take to get your share up, it's going to be impressive clinical results. And so that will show up two ways, one in the day-to-day experiences of clinicians and patients, and the other is when they actually get a chance to see some of our results. And you see more and more data that is going to become available over time as you see clinical information. So even at the upcoming conference, I think you'll see more information on some of our early clinical experience. At this point, we're not even in every country in Europe, but our focus, just to underline the point again, is not on share. This is a really big opportunity. There are so many patients with mitral regurgitation, and there's many that are just not indicated not being well served today. That's where our focus is. Thanks, Mike.
spk10: Our next question comes from Adam Mater with Piper Sandler. Please go ahead with your question.
spk07: Hey guys, good afternoon. Thanks for taking the questions. Just one from me on the US TAVR market and competition specifically. There's a new TAVR competitor that recently entered the market. I know it's early here, but have you seen any impact in the marketplace and can you comment on how that new competitor is approaching the market? Anything from a pricing standpoint? And then maybe just more broadly, how do you see the potential impact of this third player going forward? Thanks so much.
spk08: Yeah, thanks, Adam. Yeah, when we talked about our results, whether it was our global results or our U.S. results, what we said, it was broad-based, but the procedure, volume, growth, and the Edwards growth were comparable. So we really didn't see anything that was noteworthy here in terms of talking about share. So, you know, we mentioned before that we have a full complement of competitors in Europe, and so that may be some kind of a leading indicator, but we just haven't seen anything in the data in the U.S.
spk07: Okay, understood. Thanks, Mike.
spk08: Sure.
spk10: Our next question comes from Anthony Patron with Jefferies. Please go ahead.
spk14: Thanks. One quick follow-up for Scott is just on the expectations on the analyst day. I just want to make sure, is the company issuing top line guidance or is it just P&L guidance? And then a question on low risk. We are seeing DTC advertising in other areas of med tech, albeit it's more in consumer health facing markets. But does DTC in low risk make sense here to open up that opportunity, you know, as we move into a period of higher vaccination and eventually antivirals? Thanks.
spk04: Yeah, thanks, Anthony. Relating to the investor conference, we're expecting to provide guidance for the top line and the rest of the income statement. So, you know, typically we talk about sales dollar ranges and underlying growth rates based upon our forecast for how the year is going to end up when we get to December. And we'll also talk about margins, gross margin, operating margins, and whatever other financial metrics we've got clarity enough on to guide to. As it relates to DTC, I'll start, and then Mike can offer perspective as well. You know, we think that market activation and inspiring more patients to come in to get treated is a really important part of the future and the long-term growth of TAVR. And so we are already investing some resources around getting directly to patients, to primary care physicians, to referring physicians, and we'll be doing more of that in the future. it's not aimed specifically at a patient in a particular risk category. We're trying to get to all patients who have severe symptomatic aortic stenosis, and we expect that's going to be an important driver of growth.
spk08: Yeah, I'll just pile on there, Anthony. Thanks. It's a good question. You know, if you go back historically, in the early days of TAVR, we really counted on the physicians that did TAVR to educate their referring base, and that's the way that we counted on the word getting out. And I don't know, we were under the impression that that actually would be sufficient. But we've learned over the years that that's dramatically insufficient. And so, as Scott said, we've gone down a number of roads here to make sure that the referral base is indeed educated. We've made some good progress there, although we're far from satisfied in terms of where we are right now. But to be really specific, going all the way upstream to consumer markets, We do believe that that could be a valuable lever. We're specifically doing some experimenting in that regard and maybe have some more specific things to share with you when you come to the investor conference.
spk10: Thank you. Our next question comes from Joanne Wench with Citi. Please, dear question.
spk13: Good afternoon. Thank you for taking the question. Can we spend a minute on critical care programs? the last couple of quarters have been particularly strong. Is it possible to tease out how much of that strength is just underlying? In other words, it'll continue into 2022 and 23, or it's just sort of, I want to call it one time in nature associated with the pandemic.
spk08: Yeah. Thanks. It's a good question, Joanne. I mean, if you were to ask our team, gee, are you going to keep growing at 17%? I think they'd say, no, that's not realistic that, that we got, We got some help this quarter by some large U.S. capital orders that really helped out, and that made a difference. Now, overall, are we pleased with what's going on in critical care? Is there more innovation than ever? Are they sustaining a pretty healthy growth rate that are better than, I think, MedTech averages? I think all those are true, and we're very proud of that, and we're going to continue hitting it hard in that regard. But in terms of being able to maintain these kind of growth rates that we did in this quarter, that's not likely.
spk13: And then as a follow-up question, use of cash, can you remind us of your thinking on that topic? And thank you.
spk04: Sure, I'll tackle that one, Joanne. Thanks for the question on use of cash. Really, our priorities have not changed. Our first priority is to fund prospects for long-term organic growth that are generated internally, and we want to make sure that we're fully funding those platforms. We supplement that with external investments. And so we'll, we'll buy small sized early stage, uh, companies usually pre-revenue. Uh, sometimes we invest in options to acquire companies based upon certain milestones or targets being met. Um, and so beyond growth internally and externally, then we looked at the balance sheet and we've been a consistent repurchaser of shares. As you know, we're going to continue to do that opportunistically. And we think that's going to be an important way that we can give capital back to shareholders over time.
spk13: Thank you so much.
spk10: Thank you. Our next question comes from Pito Checkering with Deutsche Bank. Please state your question.
spk05: Good afternoon, guys. Thanks for taking my questions. A follow-up on Josh's low-risk penetration question. If you look specifically at the low-risk patients, what do you see from those patients in the third quarter versus the second quarter? And what do you assume this patient's in the fourth quarter? Just curious how much that funnel has impacted in the back half of the year due to COVID.
spk08: Yeah, thanks, Peter. You know, we've said this before, so I apologize for taking you through it again. But remember, this characterization of patients by high risk, intermediate risk, and low risk was a characterization done by FDA as a regulatory pathway for TAVR to help make sure that the oldest, sickest patients were treated first at the highest risk to try and minimize the risk associated with a new therapy. When you actually look at any patient, their key concern is not whether they're at risk surviving surgery, it's what is their risk for survival? What is it like to live with TAVR versus live with aortic stenosis? That's the real question. So we spend less time, and frankly, clinicians and patients spend less time talking about whether they're low-risk or intermediate. So we really don't differentiate in that regard. So having said that, what do we think? How did patients behave in the third quarter? As I tried to infer before, we don't have perfect visibility there, but we think they were indeed seeing their doctor. They were indeed getting diagnosed. They were indeed getting screened. But there were a number of cases where the treating hospitals themselves just stopped taking patients, and that was the primary impact in the quarter.
spk05: Fair enough. And then, Scott, a follow-up question for you. You weren't changing the TMCT guidance, but it's a pretty wide range. Just curious, you know, what would have to occur at the high end versus the low end of the range? Thanks so much.
spk04: Yeah, it's a good question. And like TAVR and other businesses, a lot of this is going to depend upon how much of a factor the Delta variant plays in the fourth quarter. You know, there are a couple of different elements to our TMTT business right now. One is our commercial position in Europe where we're selling Pascal primarily. And then the other is clinical trial enrollment where there is reimbursement in the U.S. What we're really looking for is for there to be a normalization of patient flow in both areas. Europe and the U.S., and that's really going to be an important determinant for where things go in the fourth quarter. We're expecting sequential growth in Q4, and that will contribute to where we end up in that range of $80 to $100 million in expected full-year sales. Great. Thanks so much.
spk01: Thanks, Diego. I think we have time for one more question, maybe.
spk10: Thank you. And our final question comes from Chris Pasquale with Guggenheim. Please state your question.
spk06: Thanks for squeezing me in. One quick one on TMTT and then one on TAVR. Mike, in your script, you said you made progress in rolling the five TMTT pivotal trials in the quarter. I think that group of five includes Class 2D. Could you just clarify, has Class 2D actually finished enrolling? Any details there would be great.
spk08: Yeah. You know, we really haven't gotten specific on that yet. So we really don't have specific comments. But as you might imagine, we're committed to when we say that we believe that we're going to have 2D approved by late 2002, that naturally infers that we're close to having our enrollment completed. and then that will allow us to prepare for the PMA and go through that process. So a lot of that has to happen. We'll get into a little more granularity when we're together at the investor conference. Okay.
spk06: And then there's a late breaker at AHA that's looking at asymptomatic AS patients. It's not your trial, so I understand you're not fully in the weeds there, but curious if you know anything about it and to what extent that data could be instructive as we think about what we might see in the future from early to average.
spk08: Yeah, it's a good question. I don't have personal knowledge of that trial, and so I can't really comment about it. The AHA are a strong organization and good partners, and I think they really care about patients with AS. But I'm not sure precisely what trial that you're referring to, but you know how we feel about asymptomatic patients. We feel like these are patients that should be treated. This idea of deferring treatment and waiting for symptoms is an outdated idea. thought process, and we're very committed to change that through rigorous clinical trials. Thanks, Mike. Okay. Well, thanks all for your continued interest in Edwards. Scott and Mark and I will welcome any additional questions by telephone.
spk10: Thank you. This concludes today's conference. All parties may disconnect. Have a good evening.
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