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Edwards Lifesciences Corporation (EW)

Q1 2015 Earnings Call· Thu, Apr 23, 2015

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Transcript

Operator

Operator

Greetings, ladies and gentlemen, and welcome to the Edwards Lifesciences Corporation First 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. It is now my pleasure to introduce your host, David Erickson, Vice President of Investor Relations. Thank you, Mr. Erickson. 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 first 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. 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 may be found in our press release, our 2014 Annual Report on Form 10-K and our other SEC filings, 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. 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 pleased to report a robust start to 2015 with first quarter results of $590 million in total sales, representing an underlying growth rate of 21%. This reflects strong performance across all product lines and regions. Significant Transcatheter Heart Valve sales once again drove the majority of this quarter's…

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

Management

Thank you, Mike. This quarter our sales were $590 million, including $10 million of royalties, representing an increase of 13% over 2014. The strengthening of the U.S. dollar continues to have a significant impact. Excluding last year's sales return reserve and the impact of foreign currency, growth in the first quarter was 21%. Non-GAAP earnings per share grew 47% to $1.12, primarily driven by our THV sales performance. This earnings per share was higher than our expected range, primarily because of strong sales and some anticipated selling, general and administrative expenses and research and development spending that was delayed until the second quarter. The stronger U.S. dollar will have an even more significant impact to sales results during 2015 than we forecasted in our last earnings call. Based on current exchange rates, we now expect 2015 sales to be reduced by $190 million compared to prior-year rates. Like many other global companies, Edwards' earnings are subject to significant impact as a result of the large movements in currencies. However, unlike some other companies in our sector, our 2015 earnings will be largely insulated as a result of our foreign currency hedging strategy. Recall that we enter into foreign exchange hedging contracts that generate income at the gross profit line when the U.S. dollar strengthens relative to other currencies. This quarter, our gross profit margin was significantly boosted by these contracts. Additionally, our reported expenses from outside the United States were reduced by these exchange rates. Therefore, our operating margin benefited from the influence of FX rates. If rates remain at current levels, it is important to understand that our company will ultimately realize a significant negative FX impact on earnings in 2016. I'll now cover the details behind our Q1 results, including guidance for the remainder of the year. For…

David K. Erickson - Vice President-Investor Relations

Operator

Thank you, Mike. 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 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

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

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Canaccord Genuity. Please proceed with your question

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

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Canaccord Genuity. Please proceed with your question

Great. And I apologize if you went over some of this. I hopped on the call late; several calls this afternoon. But starting with the TAVI business, I heard Scott say obviously perhaps some impact from SAPIEN 3 in the fourth quarter. Could you give us a sense for the first 12 months after SAPIEN 3 launch and sort of what – obviously given that the competitor is still ramping, what sort of share thoughts you have with respect to your U.S. TAVI business sort of in the first 12 months after the SAPIEN 3 finds its way to the U.S. market? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. We're – thanks for that, Jason. We're pleased with our position today. We already have a very strong competitive position, and we're looking forward to actually have SAPIEN 3 add to that strength. Having said that, the only guidance that we're providing at this point is that we think that it's more likely that we get approval this year, and if it were to come in the fourth quarter, we were just explaining that they probably not going to have much financial impact on 2015; it'll occur in 2016. We'd be getting ahead of ourselves to lay out guidance for 2016 at this point, Jason. So, we're going to let that go. I mean, our experience in Europe has been a good one, though.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Canaccord Genuity. Please proceed with your question

Right. And the experience in Europe, how informative is it for you and for us as we look at SAPIEN 3's competitiveness there over the last 15 months? And then secondly, in Europe, I apologize again if you went over this in prepared remarks and I missed it, but our due diligence would suggest you've been getting a nice price premium with SAPIEN 3. I'm wondering if that's held in Europe and what your thoughts are with respect to pricing SAPIEN 3 in the U.S. And I'll get back in queue. Thanks. Michael A. Mussallem - Chairman & Chief Executive Officer: Thanks, Jason. Yeah, we have to be careful of not too many questions. But let me go after these. In terms of SAPIEN 3 in Europe, again we're pleased with the way that's doing. You know, it's tough to call out a perfect predictor of what's going to happen in the U.S. A lot depends on whether our competitor gets their new product launched and where their timing is versus ours. So that may be a little different than what we've seen. We've been launching SAPIEN 3 in Europe against an older generation valve of our competition for the most part. In terms of pricing, your point is a good one. We feel like we have commanded a premium price in Europe, and as we commented, our global ASPs are very stable. That's been stable by region, and I wouldn't expect that trend to change with the introduction of SAPIEN 3.

Jason R. Mills - Canaccord Genuity, Inc.

Analyst · Canaccord Genuity. Please proceed with your question

Thank you, Mike.

Operator

Operator

Thank you. Our next question comes from the line of David Roman with Goldman Sachs. Please proceed with your question. David Harrison Roman - Goldman Sachs & Co.: Thank you, and good evening, everybody. I wanted just to start with a comment, Mike, that was in the press release this time, you brought it up on the call about in anticipation that procedure volumes are likely going to slow and competitive activity pick up. I think you made the same comment in the third quarter 2014 earnings call and press release as well. Could you maybe just talk about what timeline you're thinking of when you make that comment? And has anything changed about either the market or your competitive position since you initially made those comments back in October? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Thanks, David. Yeah, it's a good comment. I mean, for a while last year I think we were surprised at the rate that the market growth increased, and we particularly saw that uptick come, I would say, starting in about Q3, because Q3 of last year we had SAPIEN XT really kicking in in the U.S. and there seemed to be a real jump in the procedure growth. And at the same time, it seemed as though there was a similar phenomena going on in Europe. So our feeling is that the comparisons get significantly different when you get into the second half of 2015, and we're just calling that to your attention. And also just the fact that competition is intensifying, both from larger competitors as well as more small ones. David Harrison Roman - Goldman Sachs & Co.: Okay. Understood. And then, Scott, I just want to be very clear on FX, so hopefully just bear with me…

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

Management

David, what I would just add is I think directionally, your math is right, just taking 250 basis points off of our expected 77% this year. We do expect some mix improvement, but we also expect some ongoing operating expenses to continue onto 2016, and those may grow. David Harrison Roman - Goldman Sachs & Co.: Okay. Got it. Thank you.

Operator

Operator

Thank you. 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

Good afternoon. Thanks for taking the question. Let me start with Mitral. Mike, over 20 patients, that's a lot. So I guess my question is, are you willing to kind of talk about the timeline at least for CE Mark approval and the design freeze? Thanks. And then I have a follow-up. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Thanks. No, we're very pleased to be gathering this level of experience at this point. And as I said, generally, we're encouraged by this. I think, the way you might think about it is we'd like to make the decision before year-end whether we move forward with the FORTIS design to a CE Mark or whether we decide to wait for a next generation that incorporates a number of enhancements to move to a CE Mark. And we haven't made that determination yet. We'd like to get some more clinical experience. But I do think that we'll make that decision yet this year.

Larry Biegelsen - Wells Fargo Securities LLC

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

Great. And then maybe you can talk about what impact you've seen so far from the data presented at ACC in both the U.S. and Europe? And how does the data at ACC affect your long-term market projection of over $3 billion in sales in 2019? Thanks. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Thanks for that, Larry. Yeah, you know, the ACC meeting actually occurred late in Q1, so it's unlikely that it had any impact really on the first quarter. And it's kind of soon even now, Larry, to estimate the immediate impact on sales. The outcomes are encouraging for the future of the therapy and the eventual expansion and the eventual approval of the indication. So that's favorable, but I don't know that we're ready to offer a formal assessment on what the overall market size will be. That'll be coming in the future.

Larry Biegelsen - Wells Fargo Securities LLC

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

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

Operator

Operator

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

Raj S. Denhoy - Jefferies LLC

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

Hi. Good afternoon. I wonder if I could ask about the sequential U.S. growth. I think last quarter was relatively flat and this quarter you saw a modest uptick but still relatively flat. Perhaps you could offer a little bit as to what you see happening and is it a question of needing to train more centers? Or anything would be helpful. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. I think, your observation is a good one, Raj. We didn't grow sequentially very much from the last quarter, but we think the market remains very favorable. Historically, it's kind of tough to know a lot quarter-to-quarter. Things tend to move around, but the overall trend has been – just been for increased market adoption. And remember, the ACC came late enough in the quarter; probably didn't have much impact. We were I'm sure impacted by the launch of our competitor, who gained some share in the U.S., probably since the end of last year.

Raj S. Denhoy - Jefferies LLC

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

Okay. Fair enough. And then just a question around centers, what's been the pace there? And in terms of new centers wanting to get trained, have you seen any change in that dynamic? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. New centers continue to want to be trained, Raj. I think there's probably something in the neighborhood of around 10 centers that were added since the beginning of the year. But remember, they have to clear the hurdles for the NCD and so they're working through that. But the preponderance of the volume, that doesn't necessarily come from the new centers. They tend to – tends to come from existing centers.

Raj S. Denhoy - Jefferies LLC

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

Okay. Thank you. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. Our next question comes from the line of Bruce Nudell with Credit Suisse. Please proceed with your question. Bruce M. Nudell - Credit Suisse Securities (USA) LLC (Broker): Good afternoon. Thanks for taking the question. Mike, just given the success of SAPIEN 3 in Europe, how should we be thinking about CENTERA, its key product advantages and whether you have balloon expandable pretty much to yourselves? Will this really be a good advantage – a good opportunity to take more – even more share? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. We're going to learn an awful lot about CENTERA as we go through our clinical trials, Bruce. And so that's going to be key for us and we're anxious. You know, generally we're so optimistic about SAPIEN 3, we think it's going to be not challenging and unlikely that people that are satisfied with SAPIEN 3 are going to switch over to CENTERA. But maybe people that are comfortable with self-expanding platforms are going to like the advantages that CENTERA offers versus other self-expanding platforms. So we'll have to see how that plays out. Again, we're in a rapid-learn mode. We did a fair amount of redesign of the delivery system on this new generation and we're just learning about that now. Bruce M. Nudell - Credit Suisse Securities (USA) LLC (Broker): And just thinking ahead to PARTNER II, I'm presuming SAPIEN 3 will be part of that approval process. And following PARTNER II, if the trial is successful and shows even superiority relative to surgery, is there ever going to be another major U.S. indication trial? Michael A. Mussallem - Chairman & Chief Executive Officer: You know, it's a good question. It's too early to tell. It's being debated pretty heavily in the clinical community about what kind of clinical evidence becomes important. But it's just too soon. We don't have anything that's really solid to give you at this point, Bruce. Bruce M. Nudell - Credit Suisse Securities (USA) LLC (Broker): Thanks so much. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. 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

Thanks so much. Good afternoon, guys. Can you hear me okay? Sorry I'm at an airport. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure can, Danielle.

Danielle J. Antalffy - Leerink Partners LLC

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

Okay. Great. Thank you so much. So, Mike, I just wanted to get some perspective on how you're thinking about market growth over the next 12 months to 24 months? I mean it just seems like we have so much momentum building behind the market here. You're seeing it play out in Europe particularly where the valves have been available for several years now and it's a more competitive environment. Yet you're still growing very healthily. And so I was hoping you could sort of provide some perspective on how – what – maybe let me ask you this way; what could derail the market from here? Or what could stop the momentum? Is there anything or is this level of growth sustainable for the foreseeable future? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah, Danielle, it's a good question. You know, we continue to think there's a large untreated population out there and that the market is going to continue to grow. And we think it's going to grow over a long-term basis because we have a lot of confidence in the fact that this therapy is going to be robust and continue to have future gains. Having said that, it's growing at some extraordinary rate right now, and I don't think there's any reason to expect that that kind of a rate can continue. As I mentioned, the comparisons are going to start getting tougher here in the second half of the year, and so the rate is going to come down but we think the market is still going to grow very nicely. This – broadly, this is the most studied class of heart valves ever, and the fundamentals remain strong. We continue to feel like this estimate that it's more than $3 billion by 2019 is very solid. And so it gives you some sense for how we feel about market growth.

Danielle J. Antalffy - Leerink Partners LLC

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

Got it. Thanks. And maybe to follow-up on that, one of the questions I get frequently is sort of, are intermediate-risk patients being treated aggressively in Europe and even now in the U.S.? And I'd love it if you could comment on that. I know you've commented in past calls, but any color there would be wonderful. Thanks so much. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. One of the things that I thought was quite instructive is when we had a chance to see what a large group of intermediate patients looked like in the U.S. PARTNER trial, right? So here were a group of I think around 1,000 patients that – whose average age was between 81 years and 82 years old, and these were considered intermediate risk. And so it gives you a sense, I think at one time people used to think that risk as measured by STS would have translated to a younger group of patients. But there's a group that are quite elderly and quite frail that still have scores, STS scores and EuroSCOREs that are quite high. And I think clinicians are using their judgment, they're looking at these patients, and they say, wow, considering their advanced age and their frailty and their comorbidities, I think I'll treat them. But I don't think you should be deluded to think that these are really healthy patients.

Operator

Operator

Thank you. Our next question comes from the line of Ben Andrew with William Blair. Please proceed with your question. Benjamin Andrew - William Blair & Co. LLC: Great. Thanks very much for taking the question. You know, Mike, obviously the surgical valve revenue is holding up well per your guidance. Do you feel like the underlying market is healthy? Or are you taking share from competitors given the referral base and things that are going on in the market? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Thanks. We think that was really noteworthy this quarter, Ben, the fact that in a quarter when we really had pretty explosive growth in transcatheter heart valves that our surgical valves grew really well. And we think the primary reason is that there were just plain more procedures done and that as the market leader we got more than our fair share of that. We may have picked up a little bit of share. I think we're picking up share in places like China. But – and I know – I think, we're doing pretty well actually around the globe. But the biggest component of this is really the market. We think that more procedures are happening. Benjamin Andrew - William Blair & Co. LLC: For my follow-up, can you talk a little bit more about Japan and how the launch is going? We're a few quarters in now, put back on track and is there a chance for upside there as people start to get exposure to the therapy more broadly? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. You know, as we mentioned, we got growth this quarter versus the fourth quarter, but it's still off a very small base. So it's not something that's really lifting us very much in that market. As we mentioned before, the adoption rate is probably slower than we originally anticipated. We got this more challenging credentialing process. We're working really hard to drive therapy adoption. We think it's going to be helpful when we pick up these additional valve sizes that are coming up here. But we continue to think it's an attractive marketplace, that it's going to grow to this $300 million to $400 million range yet this decade, by 2019. So we're optimistic about it, but it really hasn't taken off yet. Benjamin Andrew - William Blair & Co. LLC: Great. Thank you.

Operator

Operator

Thank you. Our next question comes from the line of David Lewis, Morgan Stanley. Please proceed with your question. James Francescone - Morgan Stanley & Co. LLC: Hey. Thanks for taking the question. This is actually James in for David. I wanted to follow-up on a comment that you made earlier. You broke out some math that you did on share in Europe, that now you think that some of the newer competitors in that market have about 10% procedure share. Do you have a sense of if you were to look at that a year ago where you think that metric would have been? And to what extent do you think that the share is coming from Edwards versus coming from the other large established player in the market? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Good question, James. Yeah, I wasn't talking more about – I wasn't giving a forward-looking statement about where the newer competitors were. This was more of a look at the quarter. We believe that the newer competitors represented about 10% of the procedures in the quarter. If you were to go back a year, it was less than that. I don't know what it was exactly. It was probably closer to 5% than 10%. And we think there may be a little bit of that that came from Edwards, but we think that it's been moderate. We actually have done quite well on market share overall in terms of holding. James Francescone - Morgan Stanley & Co. LLC: Okay. That's helpful. And then second, just on operating expense leverage, SG&A percent of sales this quarter in the 34%s, which I believe is among the lower numbers you've posted for quite some time. Going forward, how important is driving operating expense leverage versus investing to support growth in the business? And when do you think – or what's the year that you think we may see an inflection in terms of operating expense leverage in the P&L?

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

Management

Sure. It's Scott. I'll jump in here. First, we've been focused really carefully on trying to drive leverage in the P&L, but we're also being thoughtful about investing in two other areas. One is making sure that our operations are positioned to meet all the requirements we need to make – to meet, and also to make sure that we are positioned to produce based upon the increased demand that we're experiencing. And so that's causing us to incur more expense at the operating line. In terms of the other piece, it's really R&D, and we're going to continue to invest in R&D because we think we're getting very attractive returns on those investments. I think where we'll probably see some more leverage over time is on the SG&A line, and I don't think this quarter is necessarily a perfect indicator of where we're going to come out. We still think SG&A for the year is going to be something more like 35% to 36%, but I can just tell you that we've got plans in place to leverage our scale and leverage the investments we've made in platforms like THV, and we'll continue to see improvement over time. James Francescone - Morgan Stanley & Co. LLC: All right. Thanks very much.

Operator

Operator

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

Michael J. Weinstein - JPMorgan Securities LLC

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

Hi. Thanks for taking the questions. So two quick follow-ups. So, Scott, why do you think SG&A as a percentage of sales goes up over the balance of the year?

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

Management

A couple of things. First, we expected some additional expenses in Q1 that we now believe we'll realize in Q2. Part of that is relating to ramping up for THV launch of SAPIEN 3 in the U.S. Part of it is relating to normal seasonal increases that we experience in Q2.

Michael J. Weinstein - JPMorgan Securities LLC

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

Okay. And then, Mike, I want to go back to, I think it was, Raj's question, just you commented about just the U.S. market, which obviously had this moonshot last year after the data at ACC, the SAPIEN XT approval and your competitor coming in. And then it seems to have flattened out at a much higher level over the last couple of quarters. Can I ask the question since we're all here post-ACC, so kind of early indicators; has the market picked up on the back of the data we saw just a few weeks ago? Michael A. Mussallem - Chairman & Chief Executive Officer: No, I don't think we've anything new to share in that regard, Mike. I think, we – our guidance that says now we're at the high end of this 25% growth on an underlying basis for the full year incorporates our best thinking, so we're not signaling at some inflection point in the U.S. market.

Michael J. Weinstein - JPMorgan Securities LLC

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

Okay. But in order for that to occur I would assume you're expecting that there will be sequential growth over the balance of the year. That would seem the – the math would seem to imply that, right? Michael A. Mussallem - Chairman & Chief Executive Officer: I think there's probably some sequential growth in there, Mike, but I don't think that it's like we – probably what we sequentially experienced in 2014.

Michael J. Weinstein - JPMorgan Securities LLC

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

Yeah, understood. Okay. Thank you, guys. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. Our next question comes from the line of Kristen Stewart with Deutsche Bank. Please proceed with your question.

Brittany Henderson - Deutsche Bank Securities, Inc.

Analyst · Kristen Stewart with Deutsche Bank. Please proceed with your question

Hi, guys. It's Brittany Henderson in for Kristen. Just wanted to ask a quick question, just on the heels of ACC and seeing all of the positive data, is there any update around the intermediate risk portion of the trials for both SAPIEN 3 and SAPIEN XT? Is there any way that that approval could come sooner than expected? Michael A. Mussallem - Chairman & Chief Executive Officer: Okay. Brittany, I want to make sure that I understand your question. You're asking do – when do we think we might get the intermediate risk cohort of SAPIEN 3?

Brittany Henderson - Deutsche Bank Securities, Inc.

Analyst · Kristen Stewart with Deutsche Bank. Please proceed with your question

Yes. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. So yeah, there's a couple of things that still have to happen first. The short answer is we're really not changing our guidance. We think that that's most likely out to be towards the tail end of next year. The intermediate cohort for SAPIEN 3 has not yet reached its one-year endpoint. The XT that was studied in the PARTNER II trial has not yet reached its two-year endpoint. So we think that it's going to work through its normal course at this point.

Brittany Henderson - Deutsche Bank Securities, Inc.

Analyst · Kristen Stewart with Deutsche Bank. Please proceed with your question

Okay. And just a quick follow-up. I think we heard that SAPIEN XT two-year data is going to be published. Do you have any visibility on when that might be and possibly what medical journal? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Let me take a look here, Brittany. I'm not positive. I believe that it's been submitted, but I'm not sure what the journal is. So we'll have to get back to you on that one.

Brittany Henderson - Deutsche Bank Securities, Inc.

Analyst · Kristen Stewart with Deutsche Bank. Please proceed with your question

Okay. Perfect. That's it for me. Thank you. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. Our next question comes from the line of Bob Hopkins with Bank of America. Please proceed with your questions.

Kevin T. Strange - Bank of America Merrill Lynch

Analyst · Bob Hopkins with Bank of America. Please proceed with your questions

Hi. This is Kevin Strange in for Bob. Thanks for taking the questions. Maybe as my first question just on competitive dynamics in Europe, it's only been a couple of months, I know, since your competitor launched their recapturable device in Europe. I'm just curious if you could talk a little bit about what you're seeing in the field there? And then maybe just on repositioning (45:53) ability broadly, there's about two or three players in the market in Europe that have that feature, and just in the field as you talk to clinicians, how important do you think this feature is going to be going forward? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. In terms of – I think your first question, is it related to Medtronic's Evolut R?

Kevin T. Strange - Bank of America Merrill Lynch

Analyst · Bob Hopkins with Bank of America. Please proceed with your questions

That's correct. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. So at this point it doesn't appear to us that it's fully launched. It appears that they seem to be going at a different rate from country to country, so it's difficult for us to gauge. But we don't think that it's out there in a large way yet. So it's difficult for us to have a firm view of how it's being perceived. And in terms of other competitors, they are gaining ground. I think the larger strategic guys are probably doing a little bit better. Overall, I mean, I think what's most noteworthy is just how well the SAPIEN 3 valve is growing. I think, the data pretty much speaks for itself and so it seems to be holding up really well under the new competitors.

Kevin T. Strange - Bank of America Merrill Lynch

Analyst · Bob Hopkins with Bank of America. Please proceed with your questions

Okay. That's helpful. And then just on mitral data, you mentioned that we might see some data later on in the year at large medical meetings. Can you give us a little bit of a preview in terms of what that data might be at PCR or later in the year at TCT in terms of it's going to be more compassionate use data, is this going to be registry data, number of patients? Anything along those lines would be helpful. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. Thanks. We've tried to move away from doing compassionate use patients to instead enrolling patients in our registry. And so I think what you're more likely to see presented, at least on our side, might be an update of what's going on in those. I think our competitors are probably doing the same thing. I don't know how much experience there is out there. I would imagine that we have probably more experience than most, but you'll get a chance to see how much clinical experience there is. But we're still at this very early stage in transcatheter mitral valve.

Kevin T. Strange - Bank of America Merrill Lynch

Analyst · Bob Hopkins with Bank of America. Please proceed with your questions

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

Operator

Operator

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

Glenn J. Novarro - RBC Capital Markets LLC

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

Hi. Hey, thanks. Mike, in your prepared remarks you called out some softness, or maybe I shouldn't use the word softness, but impacting 1Q was the lack of CAP sales. And I think the CAP you're referring to was SAPIEN 3. So, can you give us an outlook as to when the CAP starts enrolling and the impact that it may have on the year. Then I've another follow-up on SAPIEN 3. Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. What I was referring to is, recall that we got approval to use SAPIEN 3 in intermediate use patients in a continued access registry. That, it was 1,000 patients and we expected that to begin, and actually we thought it was going to start contributing to sales in the first quarter and it turned out to have a very moderate impact. It got a slower start than we anticipated. There were a couple of things that made the whole documentation slow. One is that we needed to do new contracts with each of the hospitals. Then also, we're now using the TVT Registry to collect that data and that added a level of complexity. This has gone slower than we thought. We expect it to start picking up here in the second quarter and that to be exhausted during the rest of this year.

Glenn J. Novarro - RBC Capital Markets LLC

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

And is this what's giving you confidence to guide to the higher end of your range for overall SAPIEN sales? Michael A. Mussallem - Chairman & Chief Executive Officer: I think it helps to some extent, but it's probably our strong start, and coupled with our strength in Europe it gives us a lot of confidence, Glenn.

Glenn J. Novarro - RBC Capital Markets LLC

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

Okay. Then just to clarify the SAPIEN 3 comment for revenues in the fourth quarter, you're saying $10 million, but not to model $10 million. And is that because there's going to be swap-outs of XT that serves as an offset?

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

Management

Right. So it's Scott. Yeah, modeling $10 million in net revenue is probably good assumption. That's net of the swap impact, assuming it all happened in the same period. The issue is there are also expenses associated with potentially swapping out the product and by the time you get down to the bottom line in terms of earnings, it's really not going to have any impact in that period.

Glenn J. Novarro - RBC Capital Markets LLC

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

Okay. So, I can put $10 million in SAPIEN 3 in the model, but don't have it fall to the bottom line?

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

Management

That's right.

Glenn J. Novarro - RBC Capital Markets LLC

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

Okay. Thanks, Scott.

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

Management

And again, that's based on a lot of assumptions, like we get approval on the first of the quarter, but that's a fair modeling assumption.

Glenn J. Novarro - RBC Capital Markets LLC

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

Okay. Thank you.

Operator

Operator

Thank you. Our next question comes from the line of Matthew Taylor with Barclays. Please proceed with your questions.

Matt C. Taylor - Barclays Capital, Inc.

Analyst · Matthew Taylor with Barclays. Please proceed with your questions

Hi. Thanks for taking the question. I wanted to ask one just about the mechanism by which you think you're going to get earlier approval for SAPIEN 3 and whether that informs your ability to get early approvals for anything else? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. So with the SAPIEN 3 approval that we're talking about is the high risk indication. Each PMA is truly unique. In this case, I think, there's a good feeling that in this group of patients, which is a heavily studied group of patients, these high risk patients, that you learn an awful lot with 30-day data. And FDA is I think taking that seriously. When you couple that with the strength of the data and then just the encouraging discussions that we've had, and the fact that we're deep in the discussions also helps inform our feeling, our guidance at this point, that's what has us believe that. I don't think that on a wholesale basis that we should start assuming optimistic approval times on other future products.

Matt C. Taylor - Barclays Capital, Inc.

Analyst · Matthew Taylor with Barclays. Please proceed with your questions

Understood. And I guess just because the ACC data was very good, can you talk about expectations for Medicare to revisit their policies at any point in time in terms of the centers that are allowed to do TAVR, whether there may be any changes to the overall coverage guidance? Michael A. Mussallem - Chairman & Chief Executive Officer: Yes. So overall, we would expect that there's not going to be probably any changes in 2015. Beyond that there's always a possibility that they open up the national coverage determination. Usually that's preceded by a panel. So I think there would be some warning before that would happen. We would generally be supportive of anything that would open up access to more patients, but we don't see that it's clear that that's going to happen in the immediate future.

Matt C. Taylor - Barclays Capital, Inc.

Analyst · Matthew Taylor with Barclays. Please proceed with your questions

Great. Thanks a lot for your time. Michael A. Mussallem - Chairman & Chief Executive Officer: Sure.

Operator

Operator

Thank you. 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

Hi, guys. Thanks for taking the follow-up. One clarification; you raised the Transcatheter Heart Valve guidance to the high end of the range, but I didn't hear you talk about the underlying growth for overall sales. I think on the last call it was 7% to 15%. Should we assume that the guidance now is for the high end of that range? Michael A. Mussallem - Chairman & Chief Executive Officer: Yeah. I think yes, you should. Yes, we – that's the way to think about it.

Larry Biegelsen - Wells Fargo Securities LLC

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

Okay. So that still holds, the 7% to 15%, Mike?

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

Management

It's actually – hey, Larry, it's actually 7% to 11%...

Larry Biegelsen - Wells Fargo Securities LLC

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

7% to 11%, I apologize.

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

Management

– consolidated sale growth, underlying.

Larry Biegelsen - Wells Fargo Securities LLC

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

I got it. And the way to think about it is the high end at this point?

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

Management

That's right. That's a fair assumption.

Larry Biegelsen - Wells Fargo Securities LLC

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

Okay. Thanks for taking the follow-up question.

Operator

Operator

Thank you. Ladies and gentlemen, at this time there are no further questions. I would like to turn it back to management for any closing comments. Michael A. Mussallem - Chairman & Chief Executive Officer: Okay. Thank you 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 the conference number 13605453. I'll repeat those numbers, 877-660-6853 or 201-612-7415 and the conference number is 13605453. Additionally, 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 concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.