Earnings Labs

Edwards Lifesciences Corporation (EW)

Q3 2015 Earnings Call· Mon, Oct 26, 2015

$81.79

-0.57%

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Transcript

Operator

Operator

Greetings, and welcome to the Edwards Lifesciences Third Quarter 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. A 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 Mr. David Erickson, Vice President, Investor Relations. Thank you, Mr. Erickson. You may now 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 third quarter 2015 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 today's 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 and commercial matters as well as expansion of our markets. 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 on our press release, on our 2014 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 excluding special items, we are referring to non-GAAP financial measures. Otherwise, we are referring to our GAAP results. 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 third quarter results driven by total underlying sales growth of 14% and non-GAAP earnings per share growth of 34%. Strong bottom line growth was aided by our foreign exchange…

Scott B. Ullem - Corporate Vice President, Chief Financial Officer

Management

Thanks, Mike. Another strong sales performance in Transcatheter Valves drove earnings per share of $1.07 this quarter. This represented 34% non-GAAP EPS growth over the prior year. Our non-GAAP sales were $617 million, at the higher end of our guidance range, and reflected nearly 14% underlying growth compared to last year. The strong U.S. dollar continued to have a significant negative impact on reported sales which grew 1.3%. U.S. THV's non-GAAP sales of $168 million were lifted by $1 million related to the sales return reserve for the launch of SAPIEN 3. In addition, we partially reversed our reserve for the cost of SAPIEN XT products that won't be resold. The combined impact of the sales and inventory reserves increased our GAAP earnings per share by $0.02. Our non-GAAP earnings per share of $1.07 excludes this impact. I'll now cover the details behind our results including guidance for the remainder of the year. For the quarter, our gross profit margin was 76.2%, a 390 basis point improvement over the prior year. Approximately 220 basis points was attributable to favorable foreign exchange. Approximately, 110 basis points related to favorable product mix, and 60 basis points from other items including the impact of the THV sales return reserve. If foreign exchange rates remain at current levels, we expect our gross profit margin in the fourth quarter of 2015 to be approximately 75%. Given the significance of foreign exchange contracts as a component of net foreign exchange this quarter, we thought it would be helpful to provide more specific detail for modeling purposes. Our third quarter gross profit margin includes hedge contract gains of $20 million, compared to losses of $3 million in the prior year period. This brings our year-to-date hedge contract gains to approximately $50 million. And if FX rates remain…

David K. Erickson - Vice President-Investor Relations

Operator

Thank you, Mike. Before we open it up for questions, I would like to remind you to mark your calendars for the evening of Tuesday, December 8 and Wednesday, December 9 when we will be hosting our 2015 Investor Conference at our corporate headquarters in Irvine, California. This event will include discussions with key opinion leaders, updates on our latest technologies, and views on longer term market potential as well as our outlook for 2016. More information will be available in the coming weeks on our website. In order to allow broad participation in the Q&A, we ask that you please limit the number of questions. If you have additional questions, please re-enter 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. We'll now be conducting a question-and-answer session. Our first question is from Jason Mills of Canaccord. Please go ahead.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Canaccord. Please go ahead

Hi, Mike. Thanks for taking the question. Can you hear me okay? Michael A. Mussallem - Chairman & Chief Executive Officer: Sure can, Jason.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Canaccord. Please go ahead

Super. First question just with respect to the U.S. TAVI market in SAPIEN 3 in particular. You mentioned that you expect to be able to service the full demand of existing accounts by the end of the year, but it seems like you made great progress during the quarter. Can you give us quantitatively the number of accounts that you were able to service with SAPIEN 3 during the quarter? Michael A. Mussallem - Chairman & Chief Executive Officer: I think that in terms of the number of units sold, I think it was just under 50%, Jason. In terms of the number of accounts, I think it also was less than half. But you should in that assume that we probably got to some of the larger accounts first, if that's helpful.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Canaccord. Please go ahead

That is helpful. And my follow-up question is more of a longer term one. Clearly, what we've seen, investors have seen, is strong quarterly reports driven by TAVI, and we're waiting on, obviously, intermediate risk data that may expand that opportunity. At the same time, folks ask us a lot about the transcatheter mitral opportunity. So can you talk about the longer term growth of the company as you think about transcatheter valve, aortic valves over the next couple of years, perhaps maintaining strong growth, but eventually you're going to run up against a lot of large numbers and higher penetration rates? And also, juxtapose your thoughts on when transcatheter mitral might contribute to the P&L eventually, and sort of what that means for sort of a long-term, sustainable growth rate, both top line and the ability to leverage that to earnings growth over the longer term. I presume you'll touch on some of this at your Analyst Meeting, but we get the question a lot, so I just wanted to ask it. Michael A. Mussallem - Chairman & Chief Executive Officer: Thanks, Jason. That's a perfect question. I'm not sure that I can do it full justice now. You're right; we're going to make this a key focus of our conversation at the Investor Conference. I think all of your observations are something that I agree with. First of all, is our transcatheter mitral's a big opportunity? Yes, it's a very big opportunity, but it is early, Jason, and I would just caution people to say, it's a little early to be talking about when sales might happen and exactly how big that would be. We really need to get more clinical experience. But as you know, we're very excited about it and we're focused on trying to take a leadership position in that field. Probably one that has less risk from our perspective is the opportunity for indication expansion in aortic. We think that we're only treating the oldest and sickest patients today, and with the marvelous results that we've seen clinicians get with transcatheter valves so far, we really believe that the aortics are a big opportunity in the future, and we're also going to try to bring that to life a little bit more. I would call that a lower risk, more certain long-term opportunity.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Canaccord. Please go ahead

Okay. Mike, thanks. I'll get back in queue. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. The next question is from Larry Biegelsen of Wells Fargo. Please go ahead.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Wells Fargo. Please go ahead

Good afternoon. Thanks for taking the question. Scott, can you confirm, by our math the implied Q4 underlying growth in the guidance is about 7% to 14%. Is that accurate?

Scott B. Ullem - Corporate Vice President, Chief Financial Officer

Management

Larry, it is close. It's sort of in the middle of that range. It's probably 10% underlying growth for Q4.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Wells Fargo. Please go ahead

Okay. And recognizing that you're not giving guidance yet for 2016, Mike, can you just talk a little bit about some puts and takes on the top line next year, recognizing that you're not probably going to get an intermediate indication to the end of the year? And I did have one follow-up. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. We've been really pleased at the way the U.S. and Europe have been growing. But I think as you've correctly surmised, both of those countries are going to be coming up against tough comparisons in 2016. And we have a tough time predicting exactly what's going to happen quarter-by-quarter. We've demonstrated that in the past. But we have a lot of confidence in the long-term. Probably the next time that growth really kicks up again is, once we get that intermediate risk approval. So we'll be trying to bring that to light more, Larry, when we lay it out, and I assume your question is primarily about sales growth. I think you probably have a pretty good idea. I don't expect any big surprises in surgical valves or Critical Care. Did that get to your question?

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Wells Fargo. Please go ahead

Yes, it did. Thanks. That's very helpful. And Mike, so the STS database suggests that intermediate risk patients or STS 4 to 8 (25:22) represent about 20% of all surgical patients. It sounds like you think that opportunity could be bigger. Could you expand on that a little bit more, and how should we think about Europe? Thanks for taking the questions. Michael A. Mussallem - Chairman & Chief Executive Officer: You know what becomes difficult Larry is when you use the STS database to define the size of the population, you potentially run into a problem because it doesn't speak to about the number of patients that are on the sideline. We're going to try and work to bring that to life. These risk scores don't tell the whole story. And so, that's what I think is misinterpreted. I think it's a fair representation of who gets surgery, but it's not a fair representation of who is out there. And again, we'll try and make this a key focus of the investor conference to get a little deeper on that.

Larry Biegelsen - Wells Fargo Securities LLC

Analyst · Wells Fargo. Please go ahead

Thanks for taking the questions. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. The next question is from Mike Weinstein of JPMorgan. Please go ahead.

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan. Please go ahead

Thank you for taking the questions. So let me follow up just on a couple of items. Of the discussion around the transcatheter mitral valve program was helpful. Can you just talk about your latest thoughts on timing of both the CE Mark study and the U.S. feasibility? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, we're a little bit ahead of ourselves, Mike. The short answer is, we'll try and be a little bit more clear on the timing when we get to the Investor Conference. So we want to work through our operating plan process internally and be able to say something that we can have some level of confidence in. Know that, our top priority is to get clinical experience and we'd like to think that the CardiAQ Edwards valve is one that we are going to move forward with, for example, towards a CE Mark. But we're not ready to talk you about specific timing yet.

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan. Please go ahead

Okay. Then Scott, let me just rewind your commentary on the hedging gains this year that will roll off next year. So the math would imply that's about a 200 basis point headwind to gross margin next year, and about $0.35 to EPS. Is that how we should think about it?

Scott B. Ullem - Corporate Vice President, Chief Financial Officer

Management

That's right. Yes, 200 basis points for next year, but what's your $0.35? Are you talking about 2015 or 2016?

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan. Please go ahead

Well, 2016 versus 2015. So if you've got $70 million of gains this year dropping to $20 million next year.

Scott B. Ullem - Corporate Vice President, Chief Financial Officer

Management

Yeah, the GAAP, $50million is there something of that magnitude...

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan. Please go ahead

Depends on...

Scott B. Ullem - Corporate Vice President, Chief Financial Officer

Management

I think it's actually a little bit less than that Mike because you've got to tax affect the gains.

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan. Please go ahead

Tax affected U.S. rates?

Scott B. Ullem - Corporate Vice President, Chief Financial Officer

Management

Yes.

Michael J. Weinstein - JPMorgan Securities LLC

Analyst · JPMorgan. Please go ahead

Okay. So it's a little bit less than that, then. Okay. That's what I wanted to clarify. Okay, perfect. Thank you. Michael A. Mussallem - Chairman & Chief Executive Officer: You're welcome.

Operator

Operator

Thank you. The next question is from David Roman of Goldman Sachs. Please go ahead. David Harrison Roman - Goldman Sachs & Co.: Thank you. I wanted to just come back to the earlier question that was asked about sustainability of revenue growth in the THV market. Mike, in your prepared remarks, you made the comment that patients are continuing to come off the sidelines. I assume I think that was both Europe and the U.S. But if you think about the patients you're treating today, at what point do we start to dip into the prevalence pool, whereby today's revenue comes out of sort of tomorrow's opportunity versus actually sort of expanding that denominator from a penetration standpoint? Michael A. Mussallem - Chairman & Chief Executive Officer: Well, I mean, there's a fair amount of – it's a really good question, David. And it's hard to know exactly those answers. It's probably more difficult to get at in Europe than it is in the U.S. In the U.S., you have a fair amount of discipline because CMS has an NCD in place, and they basically only reimburse for labels. So I think there is a lot of compliance for people to stay on a high-risk inoperable patient pool. In Europe, we know that physicians sometimes consider age, for example, where that wouldn't necessarily be in risk scores. But bigger picture, we're still just in the oldest and the sickest overall, and I think that there's a big opportunity in intermediate and even beyond intermediate, David, for there to be growth within this field. And again, we'll try and get into it in a higher level of detail. David Harrison Roman - Goldman Sachs & Co.: Okay. That's helpful. I know you'll give us more in December. And then Scott, just a follow-up on the FX commentary and a financial item. Obviously, you do have the headwind from foreign exchange rates, but I think is it reasonable to assume that there are offsets in there as it relates to potential mix benefit, and I know you had some manufacturing cost headwinds this year you talked about earlier. Maybe just help us think about the puts and takes on the gross profit line? For SG&A, this is simply a math issue with respect to what you're compensating people within Europe by assuming – and your G&A just getting translated back at a lower rate. So next year we'll see a more natural progression of your discretionary spending. And lastly, how are you keeping the tax rates so low, given the U.S. growing as a percentage of total sales?

Scott B. Ullem - Corporate Vice President, Chief Financial Officer

Management

Sure. Well, let's start with the tax rate. In the third quarter, there was some country profitability mix that helped to keep the tax rate low. And we're going to continue to do everything we can to try to generate lower tax rate, but certainly there's upward pressure as we continue to grow our THV business in the highest tax jurisdiction. And SG&A, yeah, we've got the natural hedges built in, and I think that we're going to continue to see benefit from that as foreign exchange rates, if foreign exchange rates stay where they are today. In terms of gross profit margin, yes, there was some mix shift improvement and we expect that that will continue. In terms of the operating expenses, we have incurred additional operating expenses over the last several quarters. I'd like to think that that abates and we're working really hard on trying to keep operating expenses down as the company grows. But I'm not counting on a lot of improvement on just the manufacturing expenses, because we'll continue to make investments to make sure that we're operating the way we want to be operating. David Harrison Roman - Goldman Sachs & Co.: Great. Thank you very much.

Operator

Operator

Thank you. The next question is from Rick Wise of Stifel. Please go ahead. Rick Wise - Stifel, Nicolaus & Co., Inc.: Good afternoon, everybody. Mike, you mentioned that growth in penetrated countries moderated, earlier in the call. Can you just expand on your comments there, and any color you could give us around what's happening, I mean is this the start of something that a process that would suggest that you are more penetrated in those markets, or is this because of competition – you often speak about competition on the call, you didn't say much about it tonight? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, thanks. Rick. Yeah, I'll tell you what I was trying to do is just provide more clarity if possible. It's too early to signal a trend of what's happening in Europe. Growth continued to be strong. We are in excess of 20% growth in the quarter. But we just tried to provide you with a little bit of color because we normally draw that question in terms of what do we see across the continent. And what we saw, and it was really a small minority of countries, but some of the most penetrated countries the growth rate started to drop, and at the same time in some of the less penetrated countries the growth rate picked up. So it sort of netted out pretty similar to what it's been doing earlier in the year. But it's a phenomenon; it might be a signal that, as comparisons get tougher, things slow down. But we're watching it very closely; probably the next thing, again, we've seen growth move in spurts when intermediate risk would actually come to Europe and that might not happen until 2017. You might think that there would…

Operator

Operator

Thank you. Our next question is from David Lewis of Morgan Stanley. Please go ahead. David Ryan Lewis - Morgan Stanley & Co. LLC: Hello, good afternoon. Mike, just on the low risk trial strategy, at TCT, Larry made a case for randomized trials at TCT. Can you just give us your sense of why you think randomized trials are better than objective criteria trials, and can we expect to get an update on that in December? And then I have a quick follow up. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Thanks, David. Well, number one, we would expect to have a conservative FDA when it comes to expanding the indication for Transcatheter Heart Valves. They're going to want to feel that there's good solid data that supports it, and there's not much more scientific rigor than you can get in a randomized study. I think some of the reasons that Larry feels, let's – we ought to pause some before we go to an OPC, is to wait to have our field mature some. If you were to lock in an OPC for example, today, let's say you would have locked that in back when the SAPIEN valve was approved. Then all valves would have been compared to that valve and I'm not sure that would have served the public very well. As our technology matures and gets better, it probably starts moving to a place where it gets a closer to you say, it's at steady state and that's what you should expect from all heart valves. That's why we – Larry, would have said what he did. David Ryan Lewis - Morgan Stanley & Co. LLC: Okay. And then Mike, the other dynamic that came out of TCT, just wonder if you can…

Operator

Operator

Thank you. The next question is from Raj Denhoy of Jefferies. Please go ahead.

Raj S. Denhoy - Jefferies LLC

Analyst · Jefferies. Please go ahead

Hi. Good afternoon. Michael A. Mussallem - Chairman & Chief Executive Officer: Hi, Raj.

Raj S. Denhoy - Jefferies LLC

Analyst · Jefferies. Please go ahead

Wonder if I could follow a bit on the mitral questioning. One of the things that's kind of intriguing is your commentary around the changes you look to make to the CardiAQ technology, the leaflet changes and the various sizes and things. And I guess, the question is when you think about moving the valve into the clinic both in the United States as well as the U.S. trial, do you expect to make those changes before you begin or you will take the current generation into the clinic? Michael A. Mussallem - Chairman & Chief Executive Officer: I think our view is, and obviously this needs to be carefully worked with our clinical investigators and the FDA, but I think our current view is that we would proceed forward immediately with what we have, and that as we're able to add sizes, as we're able to add the Edwards tissue, as we're able to improve the delivery systems that we would cut those in along the way.

Raj S. Denhoy - Jefferies LLC

Analyst · Jefferies. Please go ahead

Okay. That's helpful. And then second on the Valve-in-Valve approval for XT that came out of TCT as well, maybe could you just frame your expectations around what that could mean in the quarters ahead for your performance? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. It's hard to know exactly how many valve and how large that Valve-in-Valve opportunity is. It's relatively small, Raj. It's really important to these patients because they don't have great options, and they're at high-risk for surgery to go through it. So I would very much call that a niche, and wouldn't count on that to be in itself a large driver of growth.

Raj S. Denhoy - Jefferies LLC

Analyst · Jefferies. Please go ahead

Okay. That's helpful. Thank you.

Operator

Operator

Thank you. The next question is from Glenn Novarro of RBC Capital Markets. Please go ahead.

Glenn J. Novarro - RBC Capital Markets LLC

Analyst · RBC Capital Markets. Please go ahead

Hi. Good afternoon. Mike, I was wondering... Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah.

Glenn J. Novarro - RBC Capital Markets LLC

Analyst · RBC Capital Markets. Please go ahead

...if you can give a little bit more color on U.S. SAPIEN sales. They did come in better than expected, and I remember a year ago, there was a lot of warehousing of patients waiting for SAPIEN XT. So my question is, with respect to SAPIEN 3, was the strength, was there any warehousing. That's question one. And then, I do recall of asking on the last call if there was any like ACC bump, all the good data coming out of ACC in the spring, you didn't think it'd happen in 2Q. Was there any ACC bump? And I'm assuming part of the strength was market share taking. But just any more color, that would be helpful. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah .I understand your question perfectly, Glenn, and we look at that very carefully. It's difficult for us to put our finger and say exactly what's happening. The data's been a big positive and it's definitely gotten people's attention and we think it's made this valve very popular. And we even had Howie Herrmann from the stage say that this was a preferred option for high-risk patients. I don't know about warehousing patients, but we did see this phenomena that I just spoke about a minute ago, in which when accounts were starting on SAPIEN 3, they would try and do a number of patients in a row. So might they try and do two patients or three patients or four patients within a couple of day period? Yes. Might they try and do 10 in a row to get the sort of their feel for the system and get really comfortable with it. Yes. Could that have had had some impact on our results? It might have, but it's difficult for us to say.

Glenn J. Novarro - RBC Capital Markets LLC

Analyst · RBC Capital Markets. Please go ahead

Okay. And then just as I think about 4Q and U.S. SAPIEN sales, the numbers should be higher. So you are assuming a sequential growth going into the fourth quarter, and a higher U.S. absolute number, correct? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, we would expect our Q4 sales in SAPIEN 3 to be larger than our Q3 sales, both for a couple reasons. One is, there is the natural seasonal differences. And the other is, we'll be continuing on our roll-out.

Glenn J. Novarro - RBC Capital Markets LLC

Analyst · RBC Capital Markets. Please go ahead

Okay. Great. Thanks, Mike. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. The next question is from Matt Keeler of Credit Suisse. Please go ahead. Matthew J. Keeler - Credit Suisse Securities (USA) LLC (Broker): Hey, guys. Thanks for taking the call. I wondered if you could comment a little bit on the SAPIEN 3 launch, and you talked in the past about being able to expand capacity versus XT. I was wondering, if you could put any metrics around that for maybe your busier centers in Europe, sort of how much were they able to increase capacity? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, thanks, Matt. It's a good question. It's so center specific, it's tough for us to generalize. It is true, we consistently hear this message that their capacity increases. They're able to get more cases done in a day. To be able to give you a good, hard number or an easy modeling numbers is tough for us. It is driven by shorter procedure times and so that just affects people differently. So I'm sorry, I can't give you a more specific answer. Matthew J. Keeler - Credit Suisse Securities (USA) LLC (Broker): Okay. Great. And just on the U.S. TAVI number, was there anything different in the royalties that really inflated that or was it pretty consistent with the last quarter?

Scott B. Ullem - Corporate Vice President, Chief Financial Officer

Management

Matt, it's Scott. It was pretty consistent. It might have been $1 million more than a year-ago quarter, but really you should think about $40 million, maybe a little bit higher on an annual run rate basis. Matthew J. Keeler - Credit Suisse Securities (USA) LLC (Broker): Okay. Great. Thanks, guys.

Operator

Operator

Thank you. The next question is from Matt Miksic of UBS. Please go ahead.

Matthew S. Miksic - UBS Securities LLC

Analyst · UBS. Please go ahead

Thanks for taking the questions. I have one follow-up for Scott and then one for Mike as well. On the margin question, and the impact of FX hedges next year that you talked about, is it fair or – I understand you're not giving a lot of detail yet about 2016, but is it sort of fair to expect, this year you had 200 basis points or so in this current quarter, plus the positive mix benefit of growth in TAVR, is it fair to think about next year as having this sort of 200 bp hit, then sort of offset by some continued mix benefit of a similar magnitude? Is that sort of the right way to think about the puts and takes for margins at this point? And then I had just one follow-up.

Scott B. Ullem - Corporate Vice President, Chief Financial Officer

Management

Yeah. That's a fair way to model it. A couple of hundred basis point difference in FX contract payouts offset by – partially offset by some mix improvement, which we will expect to continue.

Matthew S. Miksic - UBS Securities LLC

Analyst · UBS. Please go ahead

Great. And then Mike, you mentioned tricuspid, and some of the recent survey work we've done and conversations we've had with docs continues to kind of come up a little bit, I don't want to say wishy-washy, but just sort of like, we see this interesting, very interesting opportunity and underserved population as you do. However, maybe because it's underserved or under-diagnosed that clinicians at least the ones we talk to, many of them are sort of – they wouldn't put it on the list of bigger and more interesting, exciting opportunities. And I just would love to get some more color as to what you see that's exciting or interesting or potentially attractive here about pursuing that tricuspid opportunity. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure. And Matt, the points that you raised and the questions or the comments by physicians are completely understandable. This valve is often called the forgotten valve and very rarely do people treat a tricuspid valve on an isolated basis even when it is treated, and I think it's around 8,000 times a year today. It's usually accompanied by a treatment of the mitral valve. The question here is, we know that these heart failure patients, lots of them, and I think by our estimate 1.6 million patients also have tricuspid regurgitation, and if you were able to address it, and able to do it in a relatively safe way, could you change the quality of these patients' lives, and that's what's exciting to us. We have certainly physicians and internal folks that could tell you all the clinical reasons why that could and should be true, but the only way we're going to know it for sure is to have clinical experience. What we are encouraged by is in these first few cases, we just so far have only talked about 13 of those, the clinicians are saying, hey, it looks like our patients are feeling better. And so that's what encourages us to keep going and try and learn more, but it is too soon to know how important this might be.

Matthew S. Miksic - UBS Securities LLC

Analyst · UBS. Please go ahead

Thanks so much. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. The next question is from Danielle Antalffy of Leerink Partners. Please go ahead.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Leerink Partners. Please go ahead

Good afternoon, guys. Thanks so much for taking the question. Mike, I was hoping you could elaborate a little bit more in the U.S. on the mix between inoperable and high-risk, how penetrated are we in those segments and how much incremental penetration is there to go in both of those? Michael A. Mussallem - Chairman & Chief Executive Officer: Yes. It's a good question. Frankly, there's not a lot of data on the answer to your question. We know a lot about the patients that get surgery. We don't know a lot about the patients that are on the sidelines. Closest thing we're able to do is we're able to get patients that get echoed in hospitals, and see how often they're treated, those kind of things. But we don't know how many people are out there that are just simply not being treated either because it's not diagnosed, or their primary care physician just doesn't feel like they should refer or even if they make it to a cardiologist, the cardiologist would say, I don't think I should treat this patient. And so it's a number that's not well-known. We work pretty hard to try and get an estimate there. We'll try and talk about this more at the Investor Conference. There is some relation here that's probably pretty dramatic in the elderly, where, as you get older, the percentage goes up we think markedly and we'll try and bring that to life.

Danielle J. Antalffy - Leerink Partners LLC

Analyst · Leerink Partners. Please go ahead

Okay. That's helpful. Thank you. And then just following up on that, as we think about intermediate risk potentially coming online here in the U.S. and Europe, late 2016-ish timeframe, what about the center capacity issue, because you're obviously not really adding incremental centers at this point, so really it's existing centers doing more procedure, there is going to be an influx of patients. How do we think about how the centers can manage that influx of patients? What can they do logistically to take on that incremental volume? Thanks so much. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, thanks Danielle. It's a good question. It's been handled different ways at different centers. Clearly, they're going to get more capacity. They're getting better at it. They do more procedures per day. They're able to get their patients out of the hospital faster. All of that definitely impacts their capacity. But if they get a real step-up in volume, they have decisions to make on whether they're either going to repurpose some room that they feel is underutilized or whether they're going to build capacity. What's encouraging is that the economics that are associated with transcatheter heart valves are pretty good at most centers and I think it makes it a reasonable investment for them to tackle the capacity expansion.

Operator

Operator

Thank you. The next question is from Josh Jennings of Cowen & Company. Please go ahead. Joshua Jennings - Cowen & Co. LLC: Hi. Good evening. Thanks a lot. I just wanted to follow up on David Lewis' question earlier just on the low-risk opportunity and coming out of TCT and the FDA Town Hall meetings and maybe some discussions with the FDA, any sense in terms of when we can learn about the path forward for low-risk and what that trial design may be? Do we have to see intermediate data first? Could we hear it in December, or would we have to wait until ACC or beyond next year? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. It's a good question, Josh. We will talk about it at the Investor Conference. It doesn't necessarily have to wait for intermediate risk patients. We're feeling pretty confident about intermediate risk patients. We'll have to wait and see what that data looks like. But we're thinking about that now and engaged in dialogue on that very subject right now with physicians and FDA and to see how we might tackle it. But stay tuned. We'll let you know if we have anything more definitive to say in December. Joshua Jennings - Cowen & Co. LLC: Okay, great. And just one follow-up if I can. On the CAP program, I assume you're going to finish the 1,000 patients this year. That's going to be extended into next year. I was just wondering, should we expect that to be another 1,000 patients added on in a CAP II like program or would it be more? And then also any other – should we be expecting, just in terms of building out our clinical revenues next year, any type of low-risk trial to be started? Thanks a lot. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, no, I think your first assumption is right, Josh. You should think about it in terms of being another extension. I think in fact it was a 1,000 patient extension. So our belief is that we will be asking for and get approved by FDA extension of the CAP program and that would continue until we have approval. That's our belief at this point in time.

Operator

Operator

Thank you. The next question is from Ben Andrew of William Blair. Please go ahead. Ben C. Andrew - William Blair & Co. LLC: Hi, good afternoon, Mike. Just a couple quick questions for you. Can you talk about the mitral repair opportunity and how you all view that? And is it on a similar timeframe or different timeframe than perhaps the replacement product? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Thanks, Ben. Yeah, we continue to think that for these mitral patients that it's likely that you'll need a toolkit, that there won't be a single product that will be the right technology for all patients. And so, we think repair has an important place in the future, and again, it's only clinical data is going to tell us that for sure. The timeframe is a good question. We think that timeframes could be very similar to the replacement timeframes. It depends on how far you are on the development of that technology. But there's no reason to think that it's necessarily either faster or slower. Ben C. Andrew - William Blair & Co. LLC: Okay. And then just looking at the development of the market, both in Europe and the U.S., what are you seeing in terms of age evolution of the patients. Obviously, we all talk about high, intermediate low-risk et cetera, but are you seeing surgeons pushing into younger groups of patients or is that still sort of in the future with patient expansion? Thank you. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, thanks. Right now, we continue to see that patients are elderly. You saw our intermediate risk data. Here it was, intermediate risk patients, we would have estimated early on that those would have been patients in their 70s. When we get into low-risk patients, they're in their 60s. And here it is our intermediate cohorts and patients are still in their low 80s. I think what we're seeing treated today are largely 80-year-olds and that there is a difference between age and risk, and this is part of what we're trying to understand and we're going to try and get a little different. So stay tuned for December.

Operator

Operator

Thank you. The next question is from Kristen Stewart of Deutsche Bank. Please go ahead.

Kristen M. Stewart - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Please go ahead

Hi. Thanks for taking my question. Mike, I just wanted to confirm, just with respect to the intermediate risk indication, you are going to be going to the FDA to get SAPIEN 3 approved for that, not XT, even though XT is the first, I guess, landmark trial, being that you're pulling XT off the market or phasing it out, I guess, I should say? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. We just think – the way things have turned out, Kristen, is it looks like, coincidentally, we will have the results for SAPIEN XT in intermediate patients at two years and then also have the comparison of SAPIEN 3 to SAPIEN XT, and we'll also have those surgical patients and all that data becomes available at the same time. And if it's true, and we expect it to be the case that SAPIEN 3 is as good as SAPIEN XT, then naturally rather than go to an intermediate step, I would think that both we and the regulators would agree that we will go right to SAPIEN 3. So, all the data looks like it's going to come together at the ACC, and so it will be an opportunity to see the data in total, which includes the surgical control, the two-year XT in intermediate patients, and one year comparison of SAPIEN 3 in intermediate patients.

Kristen M. Stewart - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Please go ahead

Are you confident that the FDA will allow you approval for SAPIEN 3 without two-year data on SAPIEN 3, or do you have two-year data somewhere in Europe on SAPIEN 3? Michael A. Mussallem - Chairman & Chief Executive Officer: I don't know about confident. I mean, overall, I feel good. I think it's very logical. I think SAPIEN 3 has a great track record. You've had a chance to see the data. I think FDA probably feels pretty good about it. I thought they press released it actually when we got our approval a little earlier this year. So I would think that they would say that that would be the right thing to do from a public health perspective.

Kristen M. Stewart - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Please go ahead

Yeah. And last question I have, do you think a panel will be required as well? Is that included in your timeline when you say you'd expect approval at the tail end of 2015? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, our belief is that the data is so strong, Kristen, that we don't expect to have a panel. If we had a panel, that would be an unexpected event that would take more time.

Kristen M. Stewart - Deutsche Bank Securities, Inc.

Analyst · Deutsche Bank. Please go ahead

Okay. Thanks very much. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. The next question is from Suraj Kalia of Northland Securities. Please go ahead.

Suraj A. Kalia - Northland Securities, Inc.

Analyst · Northland Securities. Please go ahead

Good afternoon, everyone. So, Mike, a quick question for you. We know the total number of sales in the U.S. and Europe and the trend lines. Let me ask the same question a little differently. Can you give us some directional color on average utilization per center in Europe, where it is, and I'm just trying to track where U.S. is relative to Europe, the trend lines, and see how much more room on a per center – average utilization per center do we have to grow? Michael A. Mussallem - Chairman & Chief Executive Officer: Thanks, Suraj. I don't have that data available to share with you. I can tell you just based on my understanding of Europe, you have a great disparity in sizes of centers. You have some just mega centers, for example, a number of centers in Germany that are really large, and then there will be other smaller towns and smaller countries that will have smaller centers. I want to say, the number of centers across Europe and Eastern Europe probably must be in the 400 range. But we don't end up using averages very much. We try and find other ways of modeling, just because there's so much differences from center to center.

Suraj A. Kalia - Northland Securities, Inc.

Analyst · Northland Securities. Please go ahead

And, Mike, my apologies if I missed this, did you all give an update on Japan in terms of the status on TAVI? Thank you for taking my questions. Michael A. Mussallem - Chairman & Chief Executive Officer: Thanks. No, we didn't give an update on that. In general, Japan has continued to grow. It's growing sequentially. Obviously, some big growth numbers year-over-year, but you would expect that at this early stage of the launch. We have plans to bring SAPIEN 3 to Japan at some point, although we have not changed – we haven't shared any specifics on it, and we're still the only company approved in Japan. We expect to have our first competitor I think in the not too distant future.

Operator

Operator

Thank you. And that is all the time we have for questions. I would like to turn the conference back to management for any closing comments. Michael A. Mussallem - Chairman & Chief Executive Officer: Okay. Thanks all for your continued interest in Edwards. Scott and David and I welcome any additional questions by telephone. With that, 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 13620647. I'll repeat those numbers; 877-660-6853 or 201-612-7415, and the conference number is 13620647. In addition, an audio replay will be available on the Investor Relations section of our website. Thank you very much.

Operator

Operator

Thank you. Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. And thank you for your participation.