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Edwards Lifesciences Corp
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Thank you. Greetings, ladies and gentlemen and welcome to the Edwards Lifesciences Third Quarter 2020 Results Call. [Operator Instructions] Please note that this conference is being recorded. I will now turn the conference over to our host, Mark Wilterding, President of Investor Relations. Thank you. You may begin.
Thanks, Diego. Good afternoon, everyone and thank you for joining us. With me on today’s call are Mike Mussallem, Chairman and Chief Executive Officer and Scott Ullem, Chief Financial Officer. Just after the close of regular trading, Edwards Lifesciences released third quarter 2020 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 are not 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, including, but not limited to, those associated with COVID-19 pandemic that could cause actual results to differ materially. Information concerning factors that could cause these differences and important product safety information maybe found in the press release, our 2019 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 are 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 would like to turn the call over to Mike for his comments. Mike?
Thank you, Mark. Let me begin by saying I am very proud of our passionate team and the way that they continue to serve patients during this difficult period. Our supply chain has delivered and our field team has continued to support the dedicated clinicians that count on Edwards.
We are pleased to report better than expected third quarter results despite the challenges of the ongoing COVID pandemic. Sales of $1.1 billion increased 4% reflecting growth around the world. Global TAVR sales headlined our growth with continued adoption of our SAPIEN valve platform and a step-up in procedure volumes as newly diagnosed patients entered the system and were treated. In the third quarter, we are also pleased to report growing investments in new therapies and compelling clinical data announced at the recent TCT Connect Conference that we will be having a meaningful impact on future patient care.
In TAVR, third quarter global sales were $745 million, up 6%. Growth was led by therapy adoption across all geographies with notable strength in Europe. Globally, our average selling price remains stable. Although third quarter treatment rates were lifted somewhat by the postponement of treatment in the second quarter, particularly in Europe, we believe that going forward there was no significant backlog of patients in the system. Taking a step back, we know that a sad consequence of the intense focus on the pandemic has been that many patients like those with structural heart disease are delaying screening and treatment are not being treated at all. Evidence continues to suggest that delaying valve replacement for patients with aortic stenosis inevitably results in adverse events and increased mortality.
A recent Swiss study, AS Defer [ph] demonstrated that nearly 20% of patients who delayed a previous scheduled aortic valve replacement reported to the hospital with valve related symptoms or worsening heart failure. And closer to home, a study conducted last month by the structural heart program of Mount Sinai Hospital reported that 10% of patients waiting for aortic valve replacement, required urgent TAVR or passed away during the first month after elective procedures were halted due to COVID. After 3 months, 35% of patients affected by the ban on elective procedures required an urgent intervention or passed away. There is growing recognition that postponing treatment of AS has significant consequences. At the same time however, we know that this remains a very difficult time for the patients we serve as they continue to weigh the risk of COVID against the severe effects of progressive heart valve disease. Our observations indicate that most hospitals globally have determined that they can safely treat their AS patients in need and at the same time care for COVID patients. In conclusion, strong evidence indicates that TAVR is a proven therapy with excellent outcomes. It offers efficient use of hospital resources and can benefit many more patients whose structural heart disease is deadly and under-treated today.
Now, turning back to the third quarter, TAVR results by region in the U.S., our TAVR sales increased in the mid single-digit range versus last year, despite approximately 30% growth in the year ago period. We were very encouraged by the improvement in procedure volumes in Q3, with 100% of our active sites across all 50 states, performing TAVR cases, up from approximately 90% in Q2. Third quarter growth across the more than 750 centers in the U.S. was highest in smaller centers, which are providing access to a broader population of aortic stenosis patients. Two-thirds of our U.S. TAVR centers have completed training and proctoring with SAPIEN 3 Ultra and physician feedback on ease-of-use and improved paravalvular leak performance remains outstanding.
Outside of the U.S. in the third quarter, our underlying TAVR sales increased in the high single-digit range year-over-year. We continue to be encouraged by the strong international adoption of TAVR, particularly in Europe, where growth continues to be faster than expected. Edwards’ underlying TAVR growth in Europe versus the prior year was in the high single-digit range. We saw unit increases in nearly every country across Europe. Growth was driven by continued strong adoption of our SAPIEN 3 Ultra platform and although transcatheter valves have been commercially available for over a decade in Europe, AS continues to be significantly under-treated. Outside of the U.S. and Europe, we are continuing to see strong TAVR adoption driven by SAPIEN 3.
Sales growth in Japan and other regions was strong as aortic stenosis remains an immensely under-treated disease and we remained focused on increasing the availability of TAVR therapy. In China, where Edwards recently received regulatory approval to begin treating high-risk patients suffering from severe aortic stenosis, we successfully completed our first cases in the third quarter. And although it will likely take significant time to expand our TAVR presence in China, we look forward to partnering with hospitals across the country to introduce this therapy through our comprehensive, proven training program.
In summary, we anticipate regional variability due to the pandemic. Yet based on our year-to-date performance, we continue to anticipate global TAVR sales growth for 2020 will be at the high-end of our previous range of minus 5% to plus 5%. We anticipate a return to double-digit growth in 2021 and we expect quarterly growth rates to be – will be lower year-over-year in Q1 and Q4 with more normal market dynamics versus higher growth in Q2 and Q3 when the COVID impact was most severe. Global TAVR growth reinforces our belief in our projection of a $7 billion plus opportunity by 2024.
Turning to transcatheter mitral and tricuspid therapies, or TMTT, we continue to view this opportunity as one with substantial unmet patient needs and the potential to drive significant growth. Our focus will be on the advancement of three key value drivers, which we believe are the leading indicators of our success, a portfolio of differentiated therapies, favorable real-world clinical outcomes and favorable results from rigorous pivotal trials, which will ultimately support approvals and adoption. As an example of our differentiated therapies, we recently received the CE Mark and began introducing PASCAL ACE implant system for mitral and tricuspid repair. PASCAL ACE has the differentiated features of PASCAL with a narrower profile. It is designed to complement PASCAL and provide further options to optimize treatment for patients with mitral and tricuspid regurgitation.
In mitral valve replacement, we continue to advance both transfemoral EVOQUE and SAPIEN M3 platforms and we remain on track to initiate the U.S. pivotal trial for SAPIEN M3 before the end of the year. In addition, with EVOQUE tricuspid, we are encouraged by the experience gained in our early feasibility study and are on track to initiate our pivotal trial by yearend. We are pleased to demonstrate clinical success in these programs as reported at the recent TCT Connect Conference. We presented roll-in data from our Class 2D pivotal study.
In U.S. centers with no prior experience, the PASCAL system showed favorable 30-day outcomes in patients with degenerative mitral valves, including low complication rates, significant regurgitation reduction and improvements in quality of life. Our 1-year CE Mark class data for PASCAL micro repair demonstrated robust and sustained MR reduction. In addition, PASCAL tricuspid repair demonstrated positive 30-day results and Cardioband tricuspid follow-up demonstrated favorable 2-year results. And importantly, we are making progress on five TMTT pivotal studies. While initial pivotal clinical trial results could be delayed by a couple of quarters, we are now enrolling patients at pre-COVID rates and looking forward to generating a body of clinical evidence across our portfolio demonstrating excellent outcomes for each one of our therapies.
Third quarter global sales were $12 million. Although the situation remains fluid, we are able to resume activation of new centers in Europe and increase commercial procedures. We continue to advance our commercialization of PASCAL in Europe and remain focused on physician training, procedural success and patient outcomes. In summary, we expect procedures and activation of centers to continue to be subject to COVID interruptions in Europe. We anticipate TMTT sales of around $40 million in 2020 versus our previous estimate of $30 million to $45 million. In addition, while still early in the 2021 forecasting process, our aspiration is to double 2020 TMTT sales in 2021. We continue to believe that TMTT opportunity remains significant and now expect a $3 billion global market by 2025. We reiterate our confidence in this long-term opportunity and are passionate about bringing a portfolio of solutions to the many patients in need.
In Surgical Structural Heart, sales for the third quarter of $203 million were similar to the 2019 levels, decreasing 1% on an underlying basis. During the third quarter, we observed that patients were more willing to seek heart valve surgery and hospitals more able to manage surgical patient flow. Ongoing prioritization of heart surgery in many hospitals also contributed to rebounding case volumes. We remain very encouraged by the steady adoption of Edwards’ premium RESILIA tissue valves, including the INSPIRIS aortic surgical valve and the recently launched KONECT aortic valve conduit in the U.S. In the third quarter, INSPIRIS valve utilization grew in all regions, driven by increased demand among younger and more active patients. INSPIRIS is becoming the surgical valve standard of care in many geographies around the world. We continue to add new INSPIRIS centers in both the U.S. and Europe and adoption is growing in our existing centers. Following the first commercial cases of HARPOON in Q2 in Europe, we continue to focus on intensive physician training and robust data collection for this new beating heart mitral valve repair system. We are seeing positive initial patient results with faster surgery and recovery times with this minimally invasive therapy.
In summary, we continue to expect Surgical Structural Heart sales for full year 2020 will decline in the 5% to 15% range from 2019. Localized COVID-19 hotspots may continue to be headwinds to procedure growth. However, our expectation remains that in Q4, our sales will return to positive growth driven by the market adoption of our newest technologies. We are excited about our ability to provide innovative surgical treatment options for more patients and extend our global leadership in premium Surgical Structural Heart technologies.
In Critical Care, sales for the quarter were $181 million in line with the year ago period. Demand for our products used in cardiac surgeries was solid, but was offset by the COVID-driven impact of delayed elective procedures. Sales of our TruWave disposable pressure monitoring devices used in the ICU were lifted by a large one-time order in Europe associated with ICU capacity expansion. However, we continue to experience a decline in HemoSphere orders in the U.S. as hospitals continue to limit their capital spending as a result of COVID. In summary, we continue to anticipate that Critical Care sales will be negative for 2020 largely due to anticipated reduced capital spending in the U.S., which is still within our original guidance range of minus 5% to plus 5%.
And now, I will turn the call over to Scott.
Thanks a lot, Mike. Today, I will provide additional perspective on the third quarter, along with how we anticipate the rest of the year may unfold. Our 4% underlying sales growth in the third quarter was better than we expected as we performed well across all our product lines and geographies, especially Europe. Earnings were also stronger than we expected driven primarily by the top line performance, combined with our constrained spending.
As I have previously mentioned, we have implemented cost control measures during COVID, but we intentionally did not take any actions to significantly impact our employees or reduce investments supporting our long-term strategy. This allowed us to deliver a strong operating profit margin and adjusted earnings per share in the third quarter of $0.51, a 9% increase over 2019. GAAP earnings per share, was $0.01 higher at $0.52.
For the third quarter, our adjusted gross margin was 75.5%, down from 75.9% in the prior year quarter. This decrease was driven by a negative impact from foreign exchange and incremental cost associated with responding to COVID partially offset by improved manufacturing efficiencies. Selling, general and administrative expenses in the third quarter were $307 million or 26.9% of sales compared to $306 million in the prior year. This consistent level of spending included increased transcatheter structural heart and field personnel-related expenses, including expanding the TMTT field organization in Europe offset by reduced spending resulting from COVID. As I mentioned earlier, we did not initiate any actions to significantly impact our employees nor to reduce investment plans supporting our long-term strategy.
Research and development expenses in the third quarter were $196 million, or 17.1% of sales compared to $195 million in the prior year. This consistent level of spending included increased investments in transcatheter mitral valve replacement clinical trials partially offset by lower TAVR clinical trial costs and reduced spending resulting from COVID.
Turning to taxes, our reported tax rate this quarter was 10.7% or 11.2%, excluding the impact of special items. This rate included a 450 basis point benefit from the accounting for employee stock-based compensation, which was 130 basis points or $0.01 favorable to our expectations. We continue to expect our full year 2020 tax rate, excluding special items to be between 11% and 15%. Foreign exchange rates increased third quarter sales growth by 60 basis points or $7 million compared to the prior year. At current rates, we now expect FX to have a neutral impact to full year 2020 sales versus 2019. Our previous guidance estimated a negative $30 million impact. FX rates negatively impacted our third quarter gross profit margin by 140 basis points compared to the prior year. Relative to our July guidance, FX rates lifted our earnings by – earnings per share by $0.01.
Turning to the balance sheet, we have a strong balance sheet with approximately $1.9 billion in cash and investments at the end of the quarter. In addition, we have an undrawn line of credit up to $1 billion. Our public bonds of approximately $600 million don’t mature until 2028. Average shares outstanding during the third quarter were $631 million and we expect average shares outstanding for the full year to remain at this level. Recall that in June we increased the number of shares outstanding by executing a 3-for-1 stock split. Free cash flow for the third quarter was $113 million, defined as cash flow from operating activities of $216 million, less capital spending of $103 million. Our year-to-date free cash flow was $361 million. Free cash flow is negatively impacted by a $100 million payment related to the settlement of the intellectual property matter last quarter.
Now, I will finish up with our 2020 guidance for the remainder of the year. Our guidance assumes that the worst of the 20 – of the COVID financial impact to Edwards is behind us although we anticipate regional hotspots and risks for the foreseeable future. Given that, we anticipate we will achieve fourth quarter year-over-year underlying sales growth similar to the third quarter. Within our product groups, we now expect TMTT sales of around $40 million. We continue to estimate TAVR growth to be at the high-end of our previous range of minus 5% to plus 5%, Critical Care growth to be negative for 2020, but still within our previous guidance range of minus 5% to plus 5% and surgical growth still within our previous guidance range of minus 5% to minus 15% versus 2019. We are raising the bottom end of our full year adjusted earnings per share guidance range to be now between $1.85 and $1.95. And for the fourth quarter, we estimate adjusted earnings per share of $0.50 to $0.60.
And with that, I will turn it back over to Mike.
Thanks, Scott. I want to conclude by saying that Edwards is a dedicated member of the critical healthcare infrastructure and I admire the agility, resourcefulness and passion of our employees and partners in maintaining their important work on behalf of patients. Putting patients first has never been more important than it is today. And as we stand together with the global community, I am gratified for our extraordinary team and partners and I am optimistic about the future of delivering innovations to even more patients around the world.
With that, I will turn it back over to Mark.
Thank you, Mike. Before we open it up for questions, I am pleased to announce that our 2020 investor conference will be held on Thursday, December 10. We anticipate a great event in a new virtual format that I hope you will really like. As usual, this event will include updates on our latest technologies, views on longer term market potential and our outlook for the year ahead. More information will be available in the upcoming weeks on our website. With that, we are ready to take questions. In order to allow for broad participation, we ask that you please limit the number of questions to one plus one follow-up. If you have additional questions, please reenter the queue and management will answer as many participants as possible during the remainder of the call. Diego?
Thank you. [Operator Instructions] Our first question comes from David Lewis with Morgan Stanley. Please state your question.
Good afternoon. Just a couple of questions for me and thank you for taking them. So it’s heading in to Analyst Day here, I know raising guidance probably makes limited sense. But I did want to parse out sort of the fourth quarter guidance and just to be very crystal clear on what it means. Do we take the fourth quarter TAVR commentary to mean no improvement sequentially in TAVR or is it more we see some improvement at a lower rate, but we are just adjusting that for potential risk of resurgence flu what have you?
Yes. Thanks, David. So, it’s a little bit of all that. We grew 4% in the third quarter. And we said that we thought the fourth quarter growth would be similar to that, which we think is pretty remarkable in a environment like this and a real testament to our team and the supply chain. There are three factors that we considered when we set our Q4 sales guidance. One of them related to what we did last year, you will all have to remember as a total company, we grew 20% and 30% TAVR growth in Q4 of ‘19 even more in the U.S. So by comparison, it’s quite a difference, matter of fact so the absolute sales number in Q4 is going to be certainly higher than the sales number in Q3. There is an issue I think associated with our thinking related to the persistence of COVID-19 in the U.S. and Europe. We think it’s probably prudent at this stage just to be thoughtful because of the uncertainty associated with that. And then the one other factor that I will mention is, we don’t believe that there is much of a significant backlog in Europe any longer, which probably gave us somewhat of a lift, a little bit of a lift in Q3 and not be repeated in Q4.
Okay. But you are seeing improvement in September, Mike and you are seeing some improvement into October in that underlying TAVR business in the U.S.?
So, yes, we are not going to get into specific months, David, but you just have to remember the steep curve that we were growing at. So, when we – even if the growth rate will remain constant think of how many additional patients are being treated each month.
Yes. So just a sequential comp issue, totally understand. And then just maybe one clinical for me and I will jump back in queue. Just the Medtronic Head-to-Head study that you announced, Mike, just kind of curious if you think that population they described represents 40% of the available patients and frankly, some clinicians feel that trial may actually favor S3 and non-hemodynamic endpoints, just kind of curious on what patient population hit that targets and your thoughts on their strategy here and impacts to the market in general? Thanks so much.
Yes, thanks. I think it’s a testament to the fact that TAVR is certainly a competitive field right. Our whole industry is competitive and certainly TAVR is that. When we reflect on it, we put more of our focus on bringing new patients into the system. And we just think this disease is so under-treated. It’s a deadly disease. It’s what’s most important to us. If you look at why Edwards has grown in the past or why we are going to grow in the future, that’s the biggest factor. I think that we are extremely happy with SAPIEN 3and the Ultra platform and there is just a large body of high-quality clinical evidence that supports those. So, to have a Head-to-Head study on one factor, it might be it, but we believe that clinicians make decisions based on the total patient outcomes and not one singular element.
Thanks so much.
Thank you. Our next question comes from Bob Hopkins with Bank of America. Please state your question.
Okay, great. Thank you and good afternoon. Just two quick things. One is timing timeline question, the second is a TAVR follow-up. On the timeline side, Mike, I was wondering if you can just comment on any update on the readout on the asymptomatic trial and then also on timelines for U.S. PASCAL approval? I assume those are unchanged, but just wanted to check?
Yes. Thanks Bob. Yes, COVID-19 did impact the pace of enrollment much in line with other trials. We have been encouraged by the pickup with enrollment in Q3 compared to Q2, but we are not really providing an update at this time or we will have more to talk about at the investor conference and so we ask you to stay tuned for that.
Okay. And then on the TAVR follow-up side, I was curious if you are able to quantify how much reschedule procedures might have helped Q3? And I was also wondering if you could just comment on the COVID flare-up that’s going on right now? Is that something that is slowing TAVR currently or you are just sort of taking that into consideration, you are taking that possibility into consideration as you give Q4 guidance? Thank you.
Yes, in the beginning part of that question, Bob, you wanted me to get a little deeper on was about the backlog question and how much was there?
Yes. In Q3, do you have a – you may not have a, but just….
Yes. Well, so we didn’t. So we saw – we feel like we saw a different story in the U.S. and Europe and so U.S. is the biggest part of our business. We don’t think there was much clearing of the backlog in Q3. We think that there just wasn’t much carryover U.S. hospitals tend not to run with big backlogs and Europe by contrast there occasionally can be those depending on the country and we did indeed work those down. We feel like at this point in time, there aren’t backlogs that are going to significantly impact our Q4 performance. So, I don’t know if that’s clear.
Yes.
We have pretty much in the U.S. all our hospitals performing cases which means that you also have all hospitals that are screening patients. And so we are into a little bit more of a normal cadence at this point. In terms of the COVID question, I think it’s a general concern. We are not trying to signal something that an inflection point that we see just a general concern with the numbers that we are watching in the U.S. and Europe, but we think it’s prudent for us to be careful because of the uncertainty.
Yes, fair enough. Thanks so much.
Thank you. Our next question comes from Joanne Wuensch with Citi. Please state your question.
Thank you very much for taking the question. I have two. The first one is can you walk us through the bridge to doubling TMTT revenues in 2021? How much is that coming from PASCAL and your level of confidence of reaching that at this stage? And then my second question is, is geographic reach outside of the three core markets, I think has been next focused on China, where we are on that launch and expansion? Thank you.
Yes. Thanks, Joanne. As you can imagine, we are kind of early in our planning process for 2021. So, we are kind of feeling going out there a bit and extending ourselves when we talk about our aspiration to double. So, we will probably have more to talk about that to get in-depth when we are together at the investor conference. But much like this year, the majority of those sales are likely to be PASCAL. We are not necessarily – it’s going to be the addition of new sites that are going to help do that and we will have PASCAL and PASCAL ACE that will help us and we will be doing treatment of not only MR patients, but TR patients next year, meaning tricuspid. So, that combination is what’s leading us to have this aspiration to double. Your question about China, we are really pleased that we completed our first cases. We think it’s going to take significant time. Even though we are really excited about this, it was a major milestone for Chinese patients, the first time a multinational company is in there. There is just a lot of hurdles for a couple of reasons, some are self-imposed, we are committed to make sure that we really carefully work with physicians so that they get well-trained on our systems and get great results every time. There is also a fair amount of, I don’t know maybe bureaucracy is not the right term, but there is a lot of process related to really coming up in China. So, it’s going to take us some time. And frankly, it’s a new journey for us to bring a therapy that’s just novel to China. So, we don’t have a lot of experience with that.
Thank you very much.
Sure.
Thank you. Our next question comes from Raj Denhoy with Jefferies. Please state your question.
Hi, good afternoon. I hate to come back to this point, but the guidance for TAVR for the year, I know you are talking about sort of 5%, the upper end of the previous range. It sort of implies that the fourth quarter is going to be relatively flat I guess to the kind of 6% into this quarter. And I appreciate the commentary around Europe and maybe not seeing a bolus there. But I guess I am just curious whether there is anything more to that right, is that really a kind of pullback from where you are seeing or is it really just kind of a flattening of the recovery here into the back half of the year or the last quarter of the year?
Yes, maybe I am looking at this much different than you, Raj, I am really excited about what’s going on with our business and the fact that we are going to be able to maintain this kind of growth rate and when you consider that last year TAVR grew 30% globally. As a matter of fact, I think it was 40% in the U.S., and then we are going to put a growth rate on top of it, while the global pandemic is going on. I mean, I feel pretty proud of that. And I don’t know that it gets a lot better than that. So to think that there is something that we feel uncomfortable about is probably reading the signals wrong. And I maybe I didn’t say it the way I really feel about it.
No, that’s crystal clear. Yes, definitely glass half full, not half empty. So it’s crystal clear. And maybe just on PASCAL rate, so a decent, a good quarter actually in terms of where you ended up there, is that any indication of what’s happening on the ground in Europe, is your strategy of pricing at a premium starting to yield some results for you there?
Yes. So, we were pleased with our results in PASCAL in the quarter. And again, it’s very fluid situation and having those ramping this up during the pandemic is a little bit challenging, but we are really pleased with the way it’s come up. It’s because we added new centers in the quarter we continue to implement what we would call our high touch models. So, we are very engaged with clinicians involved in every case and working hard to make sure that they get great results each time. So, that’s really turned out to be what’s most important for us. The pricing is as much as the same as we have talked about in the past, we do have a premium, we think this was a really good therapy and performs at a superior level. Obviously, we need to back that up with data, but our strategy is unchanged.
Okay, very good. Thank you. Appreciate it.
Sure.
Our next question comes from Robbie Marcus with JPMorgan. Please state your question.
Yes, thanks for taking the question. And I am sure you will get into this more at the Analyst Day, but I have to ask the double-digit growth next year. It’s easy comps this year and I would imagine everybody expected double-digit growth. How should we put this in perspective? Is this maybe double-digit growth CAGR off of 2019 numbers, any way you can help frame it, because I am sure there is a wide variance around what people interpret that to mean?
No, you are so right, Robbie, I mean, everybody should have some pretty terrific growth, I imagine if you are in airline, you could really have impressive growth rates coming off a low base. But one of the things that I think is remarkable about Edwards is we just didn’t take as bigger dip as many other companies. So, to return to double-digit growth, I think still is meaningful. If there is something that I can add for color it’s what I tried to relate related to the quarters. And so we would expect in quarters like one and four that are a little bit more comparable to a steady state we would be likely to see that lower growth rates and then see much higher growth rates, which would be unusual ones probably for Q2 and Q3 when COVID was hitting the hardest, but hopefully that ends up providing some color, but your point is well taken.
That’s really helpful. Appreciate it. And then maybe just a quick follow-up here, one of your competitors smaller in the TAVR space recently talked about at TCT some fatigue and structural heart trial recruiting, it sounds like you are more like back to normal, should we expect trials to continue with pre-COVID levels here given that doctors are still catching up on patients to a degree or should we expect that it was a 6-month delay for most trials and the clock can restart here? Thanks.
Yes, it’s a good question, Robbie. And as you might imagine, making predictions on something like this is challenging, we kind of stick our neck out here a little bit. When we are talking about our TMTT trials, we said we think it did go back to pre-COVID levels. And in TAVR, where we have some pretty aggressive enrollments, it’s probably getting closer, there might be a little short of it, but it’s moving along pretty well and we are hoping that the situation continues to be stable and roll that way.
Great. Thanks a lot.
Yes.
Our next question comes from Matt Miksic with Credit Suisse. Please state your question.
Hi, thanks for taking the question. I have just one follow-up on sort of the TAVR environment and one on maybe sort of pipeline for patients and the process for getting more of these patients in the center. So, the first just you mentioned, I think Mike in your prepared remarks said that smaller centers grew faster in the U.S. here in the third quarter. I am just wondering, is that is that off of more of a constrained performance in Q2 where you find that they are sort of leading or lagging. Is there any kind of pattern in large or small centers or regionally that you can talk about just color on how all these centers are coming back? And then I want to follow-up.
Yes, thanks Matt. And very fair question, we have given different guidance in the past for other quarters, we are more or less just trying to tell you what we saw, which is that the smaller centers seem to grow faster in terms of being explained the why behind that, we would be speculating to some extent. We make – we can make up stories that, maybe the larger centers are in big metropolitan areas that were harder hit by COVID, but we really don’t have hard evidence to back that up, Matt, but we just did see it in the smaller centers more than the larger.
It’s great. And then the follow-up just on the challenges around ramping up patients coming into the centers and being diagnosed, I have seen some of the data you have presented on, the number of Echos taking a dip in the toughest part of the pandemic and I am assuming, recovering coming out of that, is it sort of as you look at or centers look at trying to get their pace of patients up and going again for the reasons you described and the risks of patients and so on? Is it that Echo, is that set part of the process, is it just getting patients in to see their cardiologists? Where do you think maybe the biggest challenges are or the biggest, the greatest progress that’s been made in turning that around?
Okay. Yes. Thanks, Matt. I mean, I don’t want to miss the really big issue, which is that by and large, our conversation with hospitals, they have really strongly believed that they now know how to do TAVR cases or to treat structural heart patients and COVID patients at the same time. When this first hit in Q2 that was a question mark and I think that for all the right reasons for patients and for the health of hospitals, they figured that out. So, that’s been important. It’s hard to speak in generalities around the whole world. But if we just take U.S., which is the biggest market, when the hospital sort of closed its doors and prepared for COVID, not only did they stop doing procedures, they stopped doing screening. And so when this got turned back on, they turned on both the screening process and the actual procedures at the same way. Now, I don’t know that they have actually additional screening capacity beyond what they have had in the past. So that probably becomes somewhat of the constraint, but there probably were some patients that were either lost sadly just because they passed away or are just not in the system today, that would have been otherwise in a more normal year.
Thank you for the color.
Our next question comes from Danielle Antalffy with SVB Leerink. Please state your question.
Hey, good afternoon, guys. Thanks so much for taking the question. Just a question on PASCAL in Europe and I am curious, Mike, if you could give a little bit of color on how centers are adopting PASCAL, we saw with TAVR, a lot of these centers carry more than one device on the market? Are you see – on their shelves, I am sorry, are you seeing the same with the mitral repair product or they are switching essentially to PASCAL from MitraClip?
Yes, it’s a good question. And I know I probably will be generalizing to some extent. So that’s all already dangerous. But I wouldn’t say that we see people completely switch from one system to another, I think that we see them more or less split again that they are very interested in PASCAL, they invite us in, in many cases, they are learning. We are part of the procedures and help them work through it. As we think about, maybe just give you something else to think about, I know we are hyper focused on how much we sell on PASCAL in the quarter. But if you really look for leading indicators of what’s going to be most important for TMTT, I think those three factors, how is this portfolio of differentiated therapies really developing? Are they coming along? Are those good procedures? Are they learnable, teachable? Are they fast procedure? Are they reproducible? How about your real-world clinical outcomes? Well, you saw some of the leading indicators of that at TCT Connect and I think it’s encouraging. And then just how are we doing on the clinical trials? We have got some very rigorous clinical trials that are going to provide really incredible data. And so those are going to be the things that both lead to approvals and adoption, so although the sales are an interesting one to track, I don’t know that it’s a strong or leading indicator of some of these other factors. We frankly put more energy to make sure we get great results than just trying to maximize sales.
Got it. That’s helpful. Thanks. And then if I could ask one more question, and that is on the Head-to-Head trials that Medtronic is running or trials, the Smart trial. And just this whole dynamic of the hemodynamic gradient and I am curious if you guys have had to counter detail that at all in the fields or if this is more noise from Medtronic and something that actual physicians care about? Thank you so much.
Sure. I know our folks probably answer questions about that on a regular basis. what we know is we are just really pleased with the SAPIEN 3, and especially SAPIEN 3 Ultra performance, we think people have relied on it, not just normally, but even during this pandemic. I think the performance speaks for itself, we have got some pretty impressive data that has been generated over time, whether it’s stroke, paravalvular leak, low pacemaker rate, the list goes on and so we just had a high level of confidence in this and don’t, well we wonder where that how important that factor is going to be in long term to look at one thing.
Thanks. That’s helpful.
Our next question comes from Adam Maeder of Piper Sandler. Please state your question.
Hi, guys. Thanks for taking the questions. Maybe to start just on PASCAL is I was hoping to get some additional detail there. I think you mentioned that it has a narrow profile. So how should we think about the clinical impact is it improved safety or efficacy is it for different anatomy just any color you could provide there would be great and then I had a follow-up?
Yes, thanks for that Adam. So first of all think of it as having almost the same differentiated features as PASCAL so it has got the independent panels it has got the spacer all those things like the PASCAL but with a narrower profile it is a night in all based system, the question you asked about, okay, how is it going to manifest itself clinically? We were expecting it to be a compliment, that as physicians gain experience, they will say, oh, maybe this is a good case, to use a PASCAL ACE. Frankly, we are still early in our experience. And those are some of the answers that we are going to get as we get deeper experience at this point, we are still, it’s still new enough that we can’t say definitively where that’s going to fit on a long-term basis.
Got it, okay. Thanks for the color there, Mike. And then for the follow-up, maybe switching to TAVR just curious if you had a sense for, the number of U.S. TAVR sites that were added in Q3 what are the expectations going forward? Do you think we are in an environment now where we can see new sites start to come back online at a healthy clip? Thanks so much for taking the questions.
Yes, thanks. I am trying to think of the data I know that we talked about the fact that there were about 750. The last time we reported them, I don’t remember what the number is. And so I have to go back and check on that. Just to give you a little bit color, we are probably anticipating the U.S. that this maxes out maybe in the 850 range. So I don’t know if that helps you think about it, the rate that they are actually joining, I don’t know, off the top of my head.
Got it. Thank you.
Our next question comes from Matt Taylor with UBS. Please state your question.
Hi, thank you for the question. So I just wanted to follow-up on that center question for next year, when you are thinking about the double-digit growth? Do you need to add a lot of centers to do that? Can you talk about your assumptions for center adds and how much of that growth comes from the existing versus new centers?
Yes, thanks for that. Well, you could imagine most of our growth is going to come from existing centers, new centers, by their nature are smaller. I don’t know the specific number that’s in there. Maybe that’s a good question to ask if the investor conference, but that’s not going to be the bulk of our growth, the bulk of our growth is going to come from growth in existing centers. I remember, we are at 750 already. So to drive these kind of big numbers, you can just you can anticipate that.
And just to follow everybody kind of answering around this question. But I mean, the consensus is modeled around 19% or 20% growth when the old number and you are touching a double digit growth can you comment at all about consensus and whether you think that’s aggressive realistic is there a scenario that you can do that number?
Yes, maybe that is intimately familiar with the consensus as you are, but I will just remind you that of which say 19% is probably driven off a much lower base than Edwards is actually delivering in 2020. So, what you might want to do is to think about it more in terms of the actual sales rather than a sales growth rate.
Okay. Alright. Thanks Mike.
Our next question comes from Larry Biegelsen with Wells Fargo. Please state your question.
Hey, good afternoon, guys. Thanks for taking the question. Two, on the pipeline, one on catalyst in 2021, what are the most important ones, Mike? What – I am not interested in laundry, I am not asking for a laundry list, but what do you think the most important ones are? And I am specifically interested to know if we could see the Class 2D data next year and EVOQUE for tricuspid CE Mark approval? And I have one follow-up.
Yes, I don’t think we are going to see pivotal trial results in 2021. I think those are more likely to come in 2022. I do expect there to be a steady drumbeat of new data almost on a continuous basis. We have so many innovations going on, Larry, that I think at every meeting, you are going to see follow-ups on CE Mark studies, you are going to see first experiences, you are going to see a lot of things that are really powerful leading indicators, but in terms of the pivotal trial, I don’t think that we have one in ‘21.
Thanks. And Mike, on the tricuspid market, there does seem to be a lot of enthusiasm for transcatheter tricuspid therapies. And I guess my question for you is, do you think we are going to need randomized controlled data to kind of drive that market outside the U.S. or do you think it could develop like we saw TAVR develop before you came out with a partner trial there, you got pretty strong uptake for SAPIEN in Europe before the randomized controlled data? So what do you think, what’s your view on the tricuspid market, what it’s going to take to drive that?
Yes. So, Larry, I mean, you are pretty familiar, right. You came along for this journey in TAVR. And even though we had nice sales for TAVR in Europe, they really didn’t take off until we had the pivotal data in the U.S. and made a significant step up with those big pivotal studies. Now, having said that, kind of like TAVR, there is a lot of excitement on the part of clinicians to treat their tricuspid patients, there aren’t many answers for them. And so, they are anxious to have solutions. So, if we can deliver some results, we think it could be interesting, but by predicting the tricuspid adoption rate is still very difficult. I think it’s going to be so important for us to get some long-term results on that before we can make it. We have a lot of studies coming, TRISCEND II, the class of which was the EVOQUE trial. Of the EVOQUE TR pivotal trial, we have Class 2, which is the tricuspid trial. So, we have real trials that are pointed at and are exploring this and finding the answer to your question, but it’s still early, Larry.
Thank you, Mike.
Our next question comes from Vijay Kumar with Evercore ISI. Please state your question.
Hey, guys. Thanks for taking my question. Mike, one on TAVR, the asymptomatic market or moderate AS, if you will, either one of those, any numbers around how big these opportunities would be sizing either moderate or asymptomatic?
Yes, that’s a good question. It’s interesting almost the more we learn about AS, the more we learn about AS. The market turns out to be pretty significant of people that are undiagnosed and not really in the system. And so, it’s difficult for us to say that quantitatively, we are – we do think the asymptomatic patients is a significant population. And we think that the moderate AS is also a very significant population. We haven’t been able to accurately size those at this point. That would be a good one maybe for us to get a little deeper when we are together in December, but this one we are competent that it’s a driver and going to be a driver on a very long-term basis, but it’s not clear what the size is at this point.
Understood. And now one quick one for Scott, maybe when you look at the spending for ‘21, Scott, as marketing spend comes back, clinical trials open up, reopen or restart, I guess, how should we think about OpEx and anything on the FX dynamics from next year when you think about gross margins? Thank you guys.
Well, it’s early to talk about what our permit or our operating margins may look like in 2021 I will tell you more eager to get back to full pace of travel of being out in the field, being with customers and are ramping our clinical trials back up to your fully pre COVID levels. And so we are anticipating that those expenses will ramp as quickly as we are allowed to do it. In terms of FX for 2021, it is just premature to say when you know what happened in 2020, which is, we expected a big headwind from FX to sales. Ended up with that dissipated now we are expecting no headwinds to sales for FX. And so it just - it’s premature to speculate what that is going to look like in 2021. Although we will be talking more about that are at our investor conference when we give guidance in December.
Thank you. Our next question comes from Margaret Kaczor with William Blair. Please state your question.
Hi, this is Brandon on for Margaret, thanks for taking the questions. First one I just had on at TCT this year, there was lot of presentations or a lot of focus within the valves and valve treatment opportunity. But curious how meaningful this is today in practice or is this more of kind of a clinical focus. And you guys think that the data that is been collected so far is compelling enough to convince physicians to treat low risk patients while we are kind of waiting for long term durability data? And there was even some TAVR within SAVR So is that a meaningful opportunity as we move forward?
Yes, thanks. We are really pleased to report that five year data about in TAVR and SAVR, if you will, and it said, hey, pretty good quality of life and so forth, maintained through five years. And that data is always valuable. A little bit of what you have to do is to put it in perspective, remember that data goes back quite a ways. And so that - at that time, not sure we even had intermediate approved for very long. And so the average age of those patients were nearly 80 years old. So they were sick and at high risk. And when, if you just take a look and see what those results look like. And now, in this fast moving TAVR world where improvements have been significant, we would expect that as technologies improve, and we move to lower risk patients that those results get even better. Just having a valve and a valve option for these younger patients with tissue valves or transcatheter valve is a big deal for a them to be able to avoid surgery. So we think it’s something the clinical community and patients especially really value.
Thanks and then just in terms of kind of the rebound that’s going on within TAVR. I think in prior calls. We have kind of discussed that. It has been broad adoption within all this classes, any specific risk classes kind of leading the rebound now, and kind of are you happy with the progress being made into a low risk opportunity even through COVID? Thank you.
Yes, thanks, no, we don’t have any particular visibility of these patients by risk level that gives us a deeper insight to the question. You are asking about what we are seeing right now. So we just don’t have much on that. In terms of the adoption of low risk, we saw a pretty steep inflection point once the data was presented last year. It is getting to a point now where it’s been out there for more than a year, we are still seeing steady increases, but not at the same pace that we saw when it was first introduced last year.
Thank you.
Thank you. That’s all the time we have for questions today. I will turn it back to management for closing remarks.
Okay, well, thanks very much for your continued interest in Edwards, Scott, and Mark and I are going to welcome any additional questions by telephone and with that, Back to you, Mark.
Thank you very much, Diego. That does it from our perspective.
Thank you. All parties you may disconnect. Have a good day. Thank you.