Earnings Labs

Edwards Lifesciences Corporation (EW)

Q2 2016 Earnings Call· Wed, Jul 27, 2016

$81.91

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Transcript

Operator

Operator

Greetings, and welcome to the Edwards Lifesciences Corporation's Second Quarter 2016 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. David Erickson, Vice President-Investor Relations. Thank you. You may begin.

David K. Erickson - Vice President-Investor Relations

Management

Welcome, and thank you for joining us today. Just after the close of regular trading, we released our second quarter 2016 financial results. During today's call, we'll discuss the results included in the press release and accompanying financial schedules, and then use the remaining time for Q&A. Our presenters on today's call are Mike Mussallem, Chairman and CEO, and Scott Ullem, CFO. Before we begin, I'd like to remind you that during this call, we 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 current expectations for clinical, regulatory, reimbursement and commercial matters, as well as therapy trends and foreign currency movements. These statements speak only as of the date on which they are made and we do not undertake any obligation to update them after today. Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially. Information concerning factors that could cause these differences and important product safety information may be found in our press release, our 2015 Annual Report on Form 10-K, and our other SEC filings, all of which are available on our website at edwards.com. Also, a quick reminder that when we use the terms underlying and adjusted, we are referring to non-GAAP financial measures. Otherwise, we are referring to our GAAP results. Additional information about our use of non-GAAP measures is included in today's press release and on our website. Now, I'll turn the call over to Mike Mussallem. Mike? Michael A. Mussallem - Chairman & Chief Executive Officer: Thank you, David. We're very pleased to report strong second quarter performance, which reflected significant growth in the number of patients and physicians choosing Transcatheter Heart Valve Therapy. Our results this quarter were better than expected driving…

David K. Erickson - Vice President-Investor Relations

Operator

Thank you, Mike. Before we open it up for questions, I would like to encourage you to mark your calendars for Thursday, December 8 when we will be hosting our 2016 Investor Conference in New York. This event will include updates on our latest technologies as well as our outlook for 2017. More information will be available in the next couple of months. In order to allow broad participation in our Q&A, we ask that you please limit the number of questions. If you have additional questions, please reenter the queue, and we'll answer as many as we can during the remainder of the hour. Operator, we're ready for questions, please.

Operator

Operator

Thank you. Our first question comes from the line of Brooks West with Piper Jaffray. Please proceed with your question. Brooks E. West - Piper Jaffray & Co. (Broker): Hi. Thanks for taking the questions. Can you hear me? Michael A. Mussallem - Chairman & Chief Executive Officer: We can hear you fine Brooks. Can you hear us? Brooks E. West - Piper Jaffray & Co. (Broker): Great. Mike, actually, you were fading in and out quite a bit in the first part of your prepared remarks. I was actually going to ask if it would be possible maybe for you guys to email out your script or post it to the website, because I felt like I did miss a lot of what you said. I'm sure we'll be useful... Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Brooks E. West - Piper Jaffray & Co. (Broker): ...to try to piece it together. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. If it's helpful, I suppose if it's coming in clear now, we could maybe even read it again I suppose if it's helpful to you. Brooks E. West - Piper Jaffray & Co. (Broker): I don't know. I guess I'll defer to David Erickson on that, but I thought like I missed a lot of what was said in the first half of your remarks. Michael A. Mussallem - Chairman & Chief Executive Officer: Okay. Well, we apologize for that and we'll make sure that the transcript is available. Brooks E. West - Piper Jaffray & Co. (Broker): Perfect. I guess let me ask just two questions. First of all, congratulations on another great quarter. If in terms of raising the guidance, the Transcatheter Heart Valve guidance by $100 million, it sounds like intermediate…

Operator

Operator

Our next question comes from the line of Jason Mills with Canaccord Genuity. Please proceed with your question.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Jason Mills with Canaccord Genuity. Please proceed with your question

Thank you very much. Mike, can you hear me okay? Michael A. Mussallem - Chairman & Chief Executive Officer: I hear you great, thanks.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Jason Mills with Canaccord Genuity. Please proceed with your question

Good. Congrats on a great quarter. Michael A. Mussallem - Chairman & Chief Executive Officer: Thank you.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Jason Mills with Canaccord Genuity. Please proceed with your question

Let me follow-up on the question on the Transcatheter Valve business for a second. I'm wondering – we all have, Mike, our guesstimates with respect to how the market is bifurcated from extremely high risk, intermediate risk, down to low risk. Some of the physicians that have published on it seem to think 60% or so in the low risk, intermediate maybe a third, and high and extreme risk maybe 10%. I'm wondering if you could maybe speak to that at this point. Given the volumes, it would imply that we are seeing some risk creep. I know you get the question a lot, but it would imply that you are. I guess the underlying question is, what sort of impact do you expect in the intermediate risk approval to actually have, whether it be in terms of patient acquisition, new center development or anything else? Thanks. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure. Thanks for the question, Jason. Yeah, I realize that it must be confusing for people that are following it. And part of it is that risk ratification happened by STS score, and it's traditionally been done that way. And over time here, we've seen that risk scoring has changed, and it's changed in two ways. One, just the way that STS evaluates the patients and their scoring system themselves, and the other is that heart teams themselves are playing a significant role in that and you know that they're bringing in play factors like frailty and anatomy that aren't captured in risk score, so age certainly being a key component of that. So, I think what you're seeing right now is just a different view of patients. They look at somebody today and say, well, I consider them high risk for surgery, knowing the kind of results that they get with transcatheter heart valves. I believe they're largely staying on indication as the NCD reinforces that, but we just have less precise estimates of what high risk, intermediate risk and low risk means compared to what we've had in the past. We continue to believe that the overall TAVR opportunity is more than $5 billion by 2021 and we're seeing that adoption. In terms of what's going to happen when intermediate is approved, I think a couple of things. We try to remind you that we're treating patients under the CAP today, the continued access program. And so that would stop when this began. And also, we tend to think that we'll see more or a ramp, if you will, a gradual ramp, rather than a step function when that approval takes place, so that's our expectation.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Jason Mills with Canaccord Genuity. Please proceed with your question

That's helpful, Mike. I appreciate that. Scott, one for you with respect to the guidance. It looks like the TAVI upside that you generated, at least relative to consensus, on the top line gave you somewhere between 40% and 50% incremental margin to the operating income line just given the beat there relative to consensus, whereas the guidance that you've given, a $100 million increase in TAVI relevant to the increase on the bottom line, would imply a much lower incremental margin for the balance of the year. Is that the spending – incremental spending – the surge in spending that you talked about last quarter and should we see a little bit better incremental margins as you roll off that surge, I guess, maybe in 2017? Thank you very much for taking the questions. Scott B. Ullem - Chief Financial Officer & Corporate Vice President: It is related to the capacity expansion activities we talked about. Just recall, for the $100 million guidance raise, part of that was already experienced in the second quarter along with the incremental profitability. So, about a third of that $100 million sales guidance increase will drop through to the operating income line across Q2, Q3 and Q4. There is less benefit to gross profit and SG&A, primarily due to these investments we're making in manufacturing and the infrastructure that we need to sustain our growth and, also, we've got some incentive performance-driven compensation running through the P&L.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Jason Mills with Canaccord Genuity. Please proceed with your question

Okay. Thanks a lot. I'll get back in queue.

Operator

Operator

Our next question comes from the line of Mike Weinstein with JPMorgan. Please proceed with your question.

Michael Weinstein - JPMorgan Securities LLC

Analyst · Mike Weinstein with JPMorgan. Please proceed with your question

Thank you. And Mike, just two cents on the quality of the opening remarks. I would just email this around to people just because you were going in and out, and I think it's probably worthwhile for people just to catch everything that you said. I did want to get your commentary on a couple of items, Mike. I heard your update on the mitral program and I was just hoping you could give us, number one, what are the gating factors, if any, at this point to starting the CE Mark trial? And then, I wanted to follow-up on the TAVR business. Thanks. Michael A. Mussallem - Chairman & Chief Executive Officer: Thanks, Mike. First, thanks for the comment on the reception. What we'll do is we'll get that script up on the website just as soon as we can, if it's not up already, so that people can view it. In terms of the question, right now, we're teed up to start the CE Mark trial. We really don't have obstacles in front of us other than just getting the sites up. So, we're ready to go to begin the trial. There are no internal hurdles or regulatory hurdles.

Michael Weinstein - JPMorgan Securities LLC

Analyst · Mike Weinstein with JPMorgan. Please proceed with your question

And then, Mike, you made some comments that when in and out on Ultra. I was hoping you could just explain exactly what you're doing. You said that you were incorporating some of the Ultra features into the product earlier. Can you just go through that? Michael A. Mussallem - Chairman & Chief Executive Officer: Yes, thanks. Yeah, we said, given the strong performance of SAPIEN 3, we've decided to incorporate additional benefits into our new Ultra System before its introduction. This is going to move the expected European launch into the second half of 2017. So then, remember that new system features an on-balloon delivery system and a next-generation sheath technology, and we expect it to make it easier to use, reduce possible complications and shorten procedure times.

Michael Weinstein - JPMorgan Securities LLC

Analyst · Mike Weinstein with JPMorgan. Please proceed with your question

Got it. Okay. And then, just circling back on the TAVR guidance increase, so if I look at what you reported this quarter versus the Street expectations, you exceeded the Street by about 10%, or call it like $36 million, $38 million. So versus that $36 million or $38 million, you raised your guidance by $100 million, obviously suggesting that there is a fair amount of momentum in the business. Can you just talk about what you're seeing in the business today versus maybe what you were seeing earlier in the year? Because we all remember January and you guys commenting on how strong the market was in December into January and that continued, obviously, (31:43). Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, we tried to reflect that in our remarks. Recall that we felt that the U.S. market grew more than 60% in the first quarter, and here we are even though coming off a larger base, it's growing again, in our view, more than 60%. So, this is pretty terrific market growth, and we would've expected it to begin to slow. So that's one element that's stronger; and just the strength of the SAPIEN 3 data is putting us in a very favorable position as well and giving clinicians a lot of confidence. We were pleased with what's going on in Europe. We were glad to see the growth rate of Europe be 20%, and our growth tracked that. And we have had continued discussions with FDA that cause us to believe that we'll get the intermediate risk indication in the third quarter. So just a strong momentum; looking at what's ahead, we feel pretty confident about our guidance.

Operator

Operator

Our next question comes from the line of Larry Biegelsen with Wells Fargo. Please proceed with your question.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Larry Biegelsen with Wells Fargo. Please proceed with your question

Hey, guys. Thanks for taking the question and congrats on a great quarter. Hopefully, you can hear me okay. Mike, you can hear me okay? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, Larry, we hear you great. Thank you.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Larry Biegelsen with Wells Fargo. Please proceed with your question

Good. All right. So, just one on international TAVR business, and then one on the – I'll be the bad guy – on the durability question. So, in Europe, Mike, what drove the improvement in Europe from Q1 to Q2? And second, on Japan, it looks likes sales in the first quarter were about $15 million, increased to about $20 million, $25 million in the second quarter. I assume SAPIEN 3 drove that. Can you just provide a little bit more color on what's going on in both of those markets? Thanks. And then, I have my follow-up. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure. Primarily in Europe, we're seeing market growth. We saw it, really, in all countries. We saw it step up in Germany, but we saw it step up even more in the countries that are less penetrated than Germany; and those had some pretty terrific growth rates during the quarter. And then, the other thing that happened is we probably saw the share position stabilize in Europe in this last quarter, so that all contributed to that. Did that get at your question?

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Larry Biegelsen with Wells Fargo. Please proceed with your question

Yeah. And Japan, Mike, it seems like a pretty nice acceleration there. It's $20 million, $23 million, $25 million in the quarter; closed at about $15 million in the first quarter, which is obviously a pretty nice pick up? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, I'm not sure we broke out Japan. Japan is growing at a very high rate, but remember that's a small base and still a small contributor to OUS. And we have the launch of SAPIEN 3 that's going on right now in Japan, so that's helping drive growth.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Larry Biegelsen with Wells Fargo. Please proceed with your question

All right. Fair enough. Then, Mike, on the durability question, obviously, there was some pretty un-rigorous data at PCR and some better data at TVT last month, I think you alluded to earlier. I guess, what do you think is needed to kind of address the durability question? Are you seeing any impact in the market? Obviously, the results were stellar, so the answer is probably no, but what – and lastly, are there any long-term datasets from European registries like SOURCE that you think can help address this and when could we see more data? So, thanks for taking the questions. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Thanks, Larry. Yeah, absolutely, there were some pretty sensational headlines and, certainly, those prompted questions. But to us, it really hasn't appeared that it's been a significant issue with clinicians. They remain enthusiastic about the impact that TAVR can have on their patients. I'll remind you that EuroPCR that original – those headlines hit around mid-Q2 and they didn't appear to have near-term impact on overall therapy adoption in the quarter. We are committed to studying this. So when you talk about long-term data, we can't imagine there being better long-term data than what we can generate out of our PARTNER trials. We have great datasets there, they're well controlled, and so we plan to pursue those patients on a long-term basis and follow those. And we think that will be the best way to really shine a light on the issue.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Larry Biegelsen with Wells Fargo. Please proceed with your question

Thanks for taking the questions.

Operator

Operator

Our next question comes from the line of David Lewis with Morgan Stanley. Please proceed with your question. David Ryan Lewis - Morgan Stanley & Co. LLC: Good afternoon. Mike, just a quick review and then maybe couple of follow-ups for Scott, quick ones. So, Mike, we're sort of in this weird position, right, where we have very good data from intermediate risks, we don't yet have the approval I guess, and talking to your large centers sort of intra quarter, they see a lot of demand coming. They're actually, if anything, worried about infrastructure at their center. So, it feels like they're hiring, they're training, they're making budget request for traditional infrastructure. Can you comment on what behavior you've seen out of your largest centers or, frankly, large and small centers, given the impact of this quarter kind of prior to the approval? Have you seen a change in relative activity? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, it really felt like more of a continuation of their efforts. They're enthusiastic and they continue to optimize their own programs, continue to find ways to add capacity, so this is an ongoing dialog that's going on with all the centers, large and small, and we thought one of the things that was noteworthy this quarter is the growth that we've seen out of the medium-size and small-size centers. In the past, it felt like there was an awful lot that came out of the largest centers, and it feels broader based at this point. David Ryan Lewis - Morgan Stanley & Co. LLC: Okay, very helpful. And then, Scott, just a couple of quick financial questions. The first is just my favorite question on margins. Your back half guidance basically implies that margins head higher as a…

Operator

Operator

Our next question comes from the line of Matt Miksic with UBS. Please proceed with your question. Matt, your line is open, so if you would like to ask a question.

Matt Miksic - UBS Securities LLC

Analyst · Matt Miksic with UBS. Please proceed with your question. Matt, your line is open, so if you would like to ask a question

Hi. Can you – sorry about that, can you hear me okay? Michael A. Mussallem - Chairman & Chief Executive Officer: We can hear you now, Matt.

Matt Miksic - UBS Securities LLC

Analyst · Matt Miksic with UBS. Please proceed with your question. Matt, your line is open, so if you would like to ask a question

Great. Thank you. So, just a follow-up on capacity and how the U.S. centers are adjusting to volumes. Can you talk at all about some of the procedure optimization best practices in some of these larger centers that and how, as we think about how you're positioned to sort of address those and optimize procedure times, hospital stays and that sort of thing as these folks look to get more efficient today and going forward? And I have one follow up. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. It's a mix of things. Probably the single biggest one is that they're able to do more cases per day with SAPIEN 3 than they have in the past. And so that's adding capacity, and just adding a little bit of case per day adds an awful lot of capacity when you aggregate that. That's also integrated with what's going on today with the minimalist approach, which includes conscious sedation, shorter ICU stays, you don't have to coordinate with an anesthesiologist the way you used to and so forth. And those are truly adding capacity to the system. I think you broadly are watching people share best practices and improve their efforts across the board.

Matt Miksic - UBS Securities LLC

Analyst · Matt Miksic with UBS. Please proceed with your question. Matt, your line is open, so if you would like to ask a question

Okay. That's helpful. And just in terms of the speed of getting a procedure done. If we think about the kinds of patients that (41:25) intermediate risk, you talked a lot about over the past year or so as difference between what's a low risk, what's an intermediate risk, what's a high risk patient look like, obviously, not just an STS score, but can you frame for us anything about how far we're tipping into sort of intermediate risk today on an STS basis and understanding there's co-morbidities and other elements that make a patient high risk and then how that might change as we get post approval just to give it sense of how these assessments may change in the back half of the year into next year? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. I guess I know we try and talk about it a lot and this must be difficult if you're a couple of steps away from this. But the STS score is not becoming as relevant as it was in the past. The heart teams have really taken ownership of these issues of which patients and they're utilizing their judgment. We think that broadly hospitals are saying on indication and that's been very clear, because remember you have an NCD in place that drives discipline in that regard. Having said that, if you are on the borderline of high risk and intermediate risk, might those patients be judged as somebody that should be treated today, yes, that's very possible.

Matt Miksic - UBS Securities LLC

Analyst · Matt Miksic with UBS. Please proceed with your question. Matt, your line is open, so if you would like to ask a question

Great. Thanks, Mike.

Operator

Operator

Our next question comes from the line of Bruce Nudell with SunTrust. Please proceed with your question.

Bruce M. Nudell - SunTrust Robinson Humphrey, Inc.

Analyst · Bruce Nudell with SunTrust. Please proceed with your question

Good afternoon. Wonderful quarter, of course. Mike, could you just – I have two questions. Mike, could you just repeat what you said about France? And if things do go well and you get relief, what would that do to the $100 million raise in TAVR guidance? Michael A. Mussallem - Chairman & Chief Executive Officer: Sure. So, what we've said is that our updated guidance anticipates that OUS sales may reflect a negative impact in the fourth quarter, that the country of France has a policy that limits annual TAVR procedures and a strong therapy adoption is outpacing this year's rate. We're working with the Ministry of Health in an effort to increase the procedure limit, but in the absence of a resolution, we expect to discontinue sales in France for the remainder of 2016 when the cap is reached, and that assumption is indeed in our guidance. So, we're not reflecting exactly how much, but that is a factor that's in there.

Bruce M. Nudell - SunTrust Robinson Humphrey, Inc.

Analyst · Bruce Nudell with SunTrust. Please proceed with your question

Okay, terrific. And then, on a day like today, you obviously don't need it. But I was wondering, could you just speak generally about the indication expansion trials beyond PARTNER III? UNLOAD was one of them. I know you're probably going to tackle some of the asymptomatic patients as well as bicuspid patients who tend to be younger; like, when might we start to see results from that and how important is that – those trials and indication expansions to the ultimate size of the market, assuming you get to $5 billion, pretty easily with what you've got indicated now and including PARTNER III? Michael A. Mussallem - Chairman & Chief Executive Officer: Okay, yeah, on UNLOAD, I don't know precise timing, and although that's going to be a contributor, it's relatively small. Probably the biggest one that's not in our estimates, that when we say it's going to be larger than $5 billion in 2021 is asymptomatic patients. And although that's not supported by current guidelines, we believe that patients with severe AF that have not yet presented with symptoms could benefit from earlier therapy. And it's an area that we have high interest. We've not yet established a timetable to begin studying the effect. It would be a groundbreaking trial. And we'd expect that there would be significant debate among the clinical community and regulators on the trial's specifics and merits. So, that's one that we'll have to stay tuned on.

Bruce M. Nudell - SunTrust Robinson Humphrey, Inc.

Analyst · Bruce Nudell with SunTrust. Please proceed with your question

Thanks so much.

Operator

Operator

Our next question comes from the line of Raj Denhoy with Jefferies. Please proceed with your question.

Raj Denhoy - Jefferies LLC

Analyst · Raj Denhoy with Jefferies. Please proceed with your question

Hi, good afternoon. I wonder if I could ask, after a quarter like you just posted in terms of the capacity in the United States, in terms of the number of centers, do you start rethinking the numbers of centers that could do that when you post a quarter like you just did? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. We're estimating that the number of centers that we're serving in the U.S. now is around 450. And there are centers that are finding ways to add the capability to be able to get within the NCD; generally, that's happening slowly, but it's happening steadily and it is a contributor to growth.

Raj Denhoy - Jefferies LLC

Analyst · Raj Denhoy with Jefferies. Please proceed with your question

So do you – I think at one point you talked about maybe 400 or plus or minus kind of centers being your view on how many there should be. Can you give an updated thought on how many centers you think we could ultimately get to in the United States? Michael A. Mussallem - Chairman & Chief Executive Officer: It's a tough one. I mean the fact that we're 450 now and probably approaching 500 is probably a newer estimate based on what we've actually experienced. It is difficult for us to project in the future and it gets affected by the level of consolidation that's going on in the U.S. hospital industry. So, difficult for us to decide exactly where that comes out at this point, Raj.

Raj Denhoy - Jefferies LLC

Analyst · Raj Denhoy with Jefferies. Please proceed with your question

Okay. And then just one quick on mitral. I appreciate your moving forward with CardiAQ valve. What are your current thoughts on repair products for functional disease? Do you feel the necessity to have sort of a complete portfolio and to move forward with those types of products as well? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, it's a great question, Raj. We think about it a lot at Edwards. We have been believers for some time that it will take a tool kit to address mitral regurgitation and heart failure, and that its unlikely that any single product is going to be a silver bullet that's going to take care of all patients. So, we continue to have a high level of interest in repair as well as replacements and it's one that we pay a lot of attention to.

Raj Denhoy - Jefferies LLC

Analyst · Raj Denhoy with Jefferies. Please proceed with your question

So, will we hear more soon I guess or? Michael A. Mussallem - Chairman & Chief Executive Officer: If we have something to share, we'll of course do that, Raj.

Raj Denhoy - Jefferies LLC

Analyst · Raj Denhoy with Jefferies. Please proceed with your question

Fair enough. Nice quarter. Thanks. Michael A. Mussallem - Chairman & Chief Executive Officer: Thank you.

Operator

Operator

Our next question comes from the line of Danielle Antalffy with Leerink Partners. Please proceed with your question.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Danielle Antalffy with Leerink Partners. Please proceed with your question

Good afternoon, guys. Thanks so much for taking the question and congrats on an excellent quarter. Mike, I'm just going to ask the intermediate risk question maybe another way, any updated thoughts on potential ultimate penetration of that market, and how quickly you can get there? Number one. And number two, what that does to the outlook for the surgical valve business and how we should be thinking about that business growing over the medium- to long-term? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, thanks. We feel really good about intermediate risk, and we felt like we had some pretty spectacular results, obviously, that suggests that the treatment with SAPIEN 3 is even better than surgery. And so, that part is very encouraging for us. But we know the practice of medicine has traditionally been slow to change and that that's going to take some time. So, we more think in our mind that it's going to be a gradual, but steady, increase. We're yet to see if that really changes the total addressable market. We've always believed that we would have intermediate risk approval and that was in our more than $5 billion estimate that we put out there when we did our Investor Conference last time. When it comes to the impact on surgical valve, you recall that we continue to have growth in aortic valves. They grew about 5% just this last quarter. So, we have not changed our view that surgical valve business is going to grow in the face of TAVR expansion. And there are several factors there. You've got the ageing global demographics working in your favor; generally, under-treatment of patients; there's more innovations of high value, like INTUITY; you got tissue to mechanical conversion; and, the emerging markets are getting wealthier and able to treat their patients. So, all those factors, we think, are going to be ones that drive growth in surgery for a while.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Danielle Antalffy with Leerink Partners. Please proceed with your question

And if I could follow up on intermediate risk, if you use the high-risk indication as a proxy, it looks like market growth has exceeded expectations on two fronts. Number one, it sounds like the aortic stenosis market, patients getting diagnosed and referred, is much larger, and then, of course, just the penetration of TAVR into the high-risk market. And I guess I'm wondering if the intermediate risk patient population is different in a way that we would not see – we could not use high risk as a proxy for intermediate risk. Does that make sense? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, I think I understand. We've struggled with this, Danielle. I think we've mentioned this in the past. We probably have a greater sense of vision for the long-term than we do in the short-term. It's very difficult for us to estimate what's going to happen quarter-by-quarter or even year-by-year. We believe that this is very successful therapy and that the data has demonstrated that it's excellent for these patients and they should get treated; in the absence, a patient – they've got a pretty poor prognosis. So we think that, ultimately, they're going to be treated, and much of this is going to depend on basically the message being out there and the referral system working. So, it's a judgment call, but we believe that this technology will continue to improve; and as it improves, more and more patients will be treated.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Danielle Antalffy with Leerink Partners. Please proceed with your question

All right. Thanks so much.

Operator

Operator

Our next question comes from the line of John Gillings with JMP Securities. Please proceed with your question.

John T. Gillings - JMP Securities LLC

Analyst · John Gillings with JMP Securities. Please proceed with your question

Hey, guys. Thanks for taking the question. Can you hear me okay? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. It's a little bit weak, John, but we hear you.

John T. Gillings - JMP Securities LLC

Analyst · John Gillings with JMP Securities. Please proceed with your question

Okay. Thanks. I'll try to talk a little louder. So, just quickly on the mitral side, you mentioned the positive jury verdict in the trade secret case against Neovasc, but there are still a number of issues that are being resolved in the post-trial motions, including whether or not there will be an injunction. And given that there are a limited number of KOLs and centers with the qualifications to run these kind of trials and that a lot of them don't want to do – trial two devices at the same time, if an injunction comes through, could we potentially see faster enrollment rates for the CardiAQ-Edwards valve and potentially shorter time lines to commercialization? Michael A. Mussallem - Chairman & Chief Executive Officer: Thanks for the question. As you know, we are waiting for the judge to render a decision on several outstanding matters, and that includes an injunction and patent ownership. So, there is the potential for multiple trials to be ongoing. We don't think that Neovasc is so advanced that they have the whole mitral clinical community tied up. So, I'm not sure that that's going to be a major factor. We think we do have access to some of the best centers in the world and we look forward to being able to get that without limitation.

John T. Gillings - JMP Securities LLC

Analyst · John Gillings with JMP Securities. Please proceed with your question

Okay. Thanks. And then, maybe just quickly to follow-up on Raj's question earlier on the repair side in mitral, any color you'd be willing to offer on your investment and option on Harpoon? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, well, we continue to like that investment. I think we talked about it a few quarters ago when we put it in place. And it's indicative of that feeling that we have that mitral repair might actually have an important place in the future. We like that particular investment because it allowed us to make a reasonable and nominal one on what we think is very promising therapy, but wait to see how the data turns out; and if it looks good, we have an option to actually acquire the company. So, we're pleased with that as a strategy and would do more like that.

John T. Gillings - JMP Securities LLC

Analyst · John Gillings with JMP Securities. Please proceed with your question

All right. Thanks a lot guys and congrats on the quarter. Michael A. Mussallem - Chairman & Chief Executive Officer: Thank you.

Operator

Operator

Our next question comes from the line of Matt Keeler with Credit Suisse. Please proceed with your question. Matt J. Keeler - Credit Suisse Securities (USA) LLC (Broker): Thanks for taking the questions, guys. Just one – first, a clarification, I think the color around Europe and the accelerating TAVI growth, did you say the impact of selling days added 5% to the quarter? Did I hear that correctly? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, essentially we think about 5% – isn't it, Scott, 63 days versus 60 days a year ago? Scott B. Ullem - Chief Financial Officer & Corporate Vice President: Yeah, which translated into about 5% benefit to underlying growth. And on a consolidated basis, it contributed to about 1.5% additional growth in the quarter for all of Edwards. Matt J. Keeler - Credit Suisse Securities (USA) LLC (Broker): Okay, so no benefit in the U.S.? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, you know, just broadly in Europe, our team feels that that patient population keeps percolating into TAVI and that there is an increase, but without a surge. Matt J. Keeler - Credit Suisse Securities (USA) LLC (Broker): Okay, that's helpful. And then, just on gross margin, you mentioned added expenses that will continue into 2017, and I would think that some of that, including hiring, training, overtime, would be more frontloaded or temporary. So, is that a reasonable way to think about it? And do you think that some of the spend will come off as we get into next year? Scott B. Ullem - Chief Financial Officer & Corporate Vice President: Yeah, I'd group it into a couple of different categories. One is, just near-term, as you can see just through our gross margin line, we're pursuing multiple avenues to increasing capacity, and those costs are coming through in the form of overtime and hiring and training at our existing facilities. We're expediting logistics to move product around the world. We're adding production equipment. We're rebalancing capacity between our facilities. So, as you look out to 2017 and beyond, we're expanding our existing facilities and we're going to open new facilities, including our new plant in Costa Rica. We will get leverage as we increase that capacity, but for the short-term, for those two reasons I just mentioned, we're going to have some continued pressure on the gross margin line. Matt J. Keeler - Credit Suisse Securities (USA) LLC (Broker): Great. Thanks for taking the questions.

Operator

Operator

Our next question comes from the line of Glenn Novarro with RBC Capital Markets. Please proceed with your question.

Glenn John Novarro - RBC Capital Markets LLC

Analyst · Glenn Novarro with RBC Capital Markets. Please proceed with your question

All right. Hi, good afternoon. I think, Mike, I think you talked about the mitral trial in Europe, 15 centers starting soon. Could you give us the number of patients and the length of follow-up for that trial? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, thanks for the question, Glenn. No, we didn't lay that out. And some of that is somewhat variable still. So, it's not clear, it's going to depend much on how we do.

Glenn John Novarro - RBC Capital Markets LLC

Analyst · Glenn Novarro with RBC Capital Markets. Please proceed with your question

Okay. When you put out the press release announcing the first implant, will we get that level of detail? Michael A. Mussallem - Chairman & Chief Executive Officer: I don't know that we'd put a press release out on the first implant. Well, I would say that would be unlikely. You are more likely to see updates at the clinical meetings. Our clinicians, they love to talk about their clinical results. So, that's where I'd expect an update. If we have something meaningful, we will certainly talk about it on our quarterly calls.

Glenn John Novarro - RBC Capital Markets LLC

Analyst · Glenn Novarro with RBC Capital Markets. Please proceed with your question

Okay. And then one last question, did I hear you correctly that you've started litigation against Boston Scientific and their Lotus valve? And if so, are you enforcing – are those the Anderson patents that you're enforcing? Thank you. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, thanks. A matter of fact, there are cases. The litigation actually was initiated by Boston Scientific, which disappointed us. But in response, we have also filed litigation against them. So, there are going to be some European cases there that come to trial early next year.

Glenn John Novarro - RBC Capital Markets LLC

Analyst · Glenn Novarro with RBC Capital Markets. Please proceed with your question

Okay. Great. Thank you.

Operator

Operator

Our next question comes from the line of Ben Andrew with William Blair. Please proceed with your question. Ben C. Andrew - William Blair & Co. LLC: Hi. Good afternoon, Mike and thanks for taking the questions. Is there an opportunity, kind of as revenues have grown so quickly, to see sort of more leverage on SG&A? And what I'm getting at it is, as the centers improve their productivity, you're not adding as many centers, is it kind of more efficient case coverage and therefore more leverage as you go over the next several quarters on the operating side? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, thanks for that, Ben. Yeah, I think your assumption overall is a good one; if all of the growth were to come in transcatheter aortic valves, that certainly should be a source of leverage, because as you correctly note, there is a limited number of centers engaged. But remember, we're also pursuing a number of other growth opportunities that might require investments in SG&A. So, we hesitate to make long-term projections about the SG&A rate, because we don't have clarity on those other investments. Ben C. Andrew - William Blair & Co. LLC: Okay. And then, Mike, you've mentioned a couple of small acquisitions in the quarter, maybe talk a little bit about what those are related to? And is there a particular area of technology innovation that's you're interested in for transcatheter specifically. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, these are transcatheter technologies that probably provide opportunities for us that are more long-term in nature. They include intellectual property and some know-how that we're very happy to get, and it's too early for us to share the particulars that are associated with that, but I…

Operator

Operator

Our final question comes from the line of Josh Jennings with Cowen. Please proceed with your question. Joshua Jennings - Cowen & Co. LLC: Hi, good evening, gentlemen. Thanks a lot. I just wanted to ask about, I believe that MedStar is enrolling a low risk trial, single arm. Do you guys – I hate to ask you about it, a trial that you're not sponsoring, but do we know anything about enrollment and whether or not we'll see any data out of that trial in 2017 prior to entering enrollment of PARTNER III. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, thanks for the question. But no, we're not a sponsor of that trial, so we really don't have insight much as to what they're doing. We're obviously focused on our PARTNER III Trial, that's what we think of greatest importance and has the opportunity to change the indication in the future. Joshua Jennings - Cowen & Co. LLC: Great. And just a follow-up question. I just wanted to ask about European guidelines. And my understanding is the timing for guideline update is next year for an intermediate risk. Is there any path for accelerated guideline update? And then just to follow-up on some of the questions about pre-intermediate risk approval utilization in those borderline cases in the U.S., any color on what's going on and what you expected to happen prior to the guideline update would be helpful? Thanks a lot. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Thanks, Josh. In Europe, it's our expectation that that's going to be a pretty deliberate process. As we indicated, we submitted our data that came from PARTNER II and that we would expect a CE Mark to occur somewhere around the first of the year. But we think guidelines probably don't get changed till possibly the third quarter of next year. They have a pretty standard process they go through. Having said that, guideline changes are helpful in Europe, but they're also – it's going to be somewhat dependent on what their decisions are on a country-by-country base related to their reimbursement. In the U.S., probably the best guidance we have right now is what we just did for the quarter. As we try and project ahead and know exactly what clinicians would do, it's difficult for us to say. We hear a lot of positive messages, but we also believe that people are going to stay disciplined on indication and that our teams are the ones that are really driving the therapy adoption at this point. So, it's probably all the help that I can provide at this point. Joshua Jennings - Cowen & Co. LLC: Thank you very much. Michael A. Mussallem - Chairman & Chief Executive Officer: Okay. Well.

Operator

Operator

There are no questions at this time... Michael A. Mussallem - Chairman & Chief Executive Officer: All right. Thank you very much for your continued interest in Edwards. Scott and David and I welcome any additional questions by telephone. So, let me turn it back to you, David.

David K. Erickson - Vice President-Investor Relations

Operator

Thank you for joining us on today's call. Reconciliations between GAAP and non-GAAP numbers mentioned during this call which include underlying growth rates, sales results excluding currency impacts and amounts adjusted for special items, are included in today's press release and can also be found in the Investor Relations section of our website at edwards.com. If you missed any portion of today's call, a telephonic replay will be available for 72 hours. To access this, please dial 877-660-6853 or 201-612-7415 and use conference number 13639912. I'll repeat those numbers, 877-660-6853 or 201-612-7415 and the conference number is 13639912. Additionally, an audio replay will be available on the Investor Relations section of our website. And I will also add that the transcript will be post at the website as soon as we can get to it here this afternoon. Thank you very much.