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Edwards Lifesciences Corporation (NYSE:EW)

Q4 2013 Earnings Conference Call

February 03, 2014, 17:00 PM ET

Executives

Michael A. Mussallem - Chairman and CEO

Scott B. Ullem - Corporate VP, CFO

David K. Erickson - VP, IR

Analysts

Raj Denhoy - Jefferies

David Roman - Goldman Sachs

Frederick Wise - Stifel, Nicolaus & Co., Inc.

Bruce Nudell - Crédit Suisse AG

Jason Mills - Canaccord Genuity

Danielle Antalffy - Leerink Swann LLC

Brooks West - Piper Jaffray

Lawrence Biegelsen - Wells Fargo Securities, LLC

Ben Andrew - William Blair

Kristen M. Stewart - Deutsche Bank AG

Glenn Novarro - RBC Capital Markets

Michael Weinstein - JPMorgan Chase & Co.

Steve Beuchaw - Morgan Stanley

Robert Hopkins - Bank of America Merrill Lynch

Operator

Greetings, and welcome to the Edwards Lifesciences Corporation Fourth Quarter 2013 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions). As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, David Erickson, Vice President, Investor Relations. Thank you. Mr. Erickson, you may begin.

David K. Erickson

Welcome, and thank you for joining us today. Just after the close of regular trading, we released our fourth quarter 2013 financial results. During today's call, we'll discuss the results included in the press release and the 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 get started, 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, our expectations regarding sales, gross profit margin, earnings per share, SG&A, R&D, interest expense, taxes, free cash flow, diluted shares outstanding and foreign currency impacts.

These statements also include our current expectations for the timing, status and expected outcomes of our clinical trials, regulatory submissions and approvals as well as expectations regarding adoption rates and potential renewed products, litigation strategies and outcomes and company growth.

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. Although we believe them to be reasonable, these statements involve risks and uncertainties that could cause actual results or experiences to differ materially from the forward-looking statements.

Information concerning factors that could cause these differences may be found in our press release, our annual report on Form 10-K for the year ended December 31, 2012, and our other SEC filings, which are available on our website at edwards.com.

Also as a quick reminder that when we use the terms underlying, excluding the impact of foreign exchange, excluding special items and adjusted for 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

Thank you, David. I'm proud to say that our strong fourth quarter results helped us finish the year as it places Edwards Lifesciences in a strong position today than any time in our history. Although our initial sales expectations for 2013 were more optimistic, we ended the year with an underlying full year sales growth of 11% and non-GAAP diluted EPS growth of 16%.

Additionally, during 2013, we launched important new products, reported strong clinical data and made significant progress on several key development milestones that position us very well for sustainable future growth. Most importantly, even more patients are benefiting from our life-saving technologies than ever before.

Now turning to our quarterly results. Total underlying sales grew 10% to $550 million. This growth rate excludes the impacts of foreign exchange and the THV sales return reserve which Scott will explain in more detail later. We're pleased with our THV results across all geographies this quarter and our exiting 2013 with strong momentum.

Underlying global THV sales were above our expectations and grew 22% to $198 million driven by especially strong growth in Europe and the contributions we expected from SAPIEN in the U.S. Outside the U.S., underlying THV sales grew 28% driven once again by strong SAPIEN XT transfemoral unit growth in Europe.

TF growth continues to be aided by the competitive strength of our 29 millimeter system. Double-digit industry growth of transcatheter valve procedures in Europe even after six years of commercial availability validates our belief in the existence of a large group of untreated patients just now seeking treatment. We estimate the patent infringement rulings in Germany had a negligible impact on sales this quarter and we continue to see only a small impact from more recent competitors.

In our first quarter of launch, THV sales in Japan were $4 million. We're very pleased with how our rollout is progressing so far and continue to believe the opportunity there is attractive. While the hospital certification process is governing the speed of the launch, the favorable reimbursement, physician enthusiasm and very high procedural success rates support our optimism for the broad adoption of our SAPIEN XT technology. We continue to believe the TAVR opportunity in Japan will grow between $300 million and $400 million in 2019.

In the U.S., underlying THV sales were $93 million for the quarter which included net stocking sales of $2 million and clinical sales of $13 million. Clinical sales were strong once again this quarter, driven primarily by the rapid enrollment of the SAPIEN 3 high-risk arm of The PARTNER II Trial.

New commercial site training picked up in the fourth quarter and by the end of the year, 290 sites in the U.S. were offering SAPIEN to their patients. Estimated procedural growth exceeded 40% this quarter over last year. Recall that the fourth quarter last year included $16 million of net stocking sales that coincided with the FDA approval of SAPIEN for high-risk patients and transapical procedures.

We're gratified that heart teams have maintained their high procedural success rates since the launch in the U.S. two years ago. We continue to believe there are great many more patients on the sidelines that will pursue transcatheter technology and are continuing to build awareness for this important therapy. Likewise, we are focusing on ways to help hospitals optimize their TAVR programs by sharing best practices which can reduce lengths of stay and improve their economics.

I'm sure you saw the announcement of a competitor that was approved to treat inoperable patients in the U.S. The timing of this was consistent with the assumptions we discussed in December and we are well prepared to respond. We plan to rapidly upgrade customers to our SAPIEN XT valve once it's approved at prices comparable to what they're currently paying for SAPIEN.

Overall, we are committed to aggressively defend our leadership position and are confident that clinicians in the U.S. will prefer SAPIEN XT as they do in Europe where we are the market leader and have been gaining share since 2010.

In summary, we're pleased with our THV results across all geographies this quarter. For 2014, given the near-term uncertainty associated with the competitive dynamics, we are reiterating our 0% to 14% underlying sales growth guidance. We expect to refine this range as we gain further clarity. Overall, we exited 2013 very strong and believe we are well positioned for durable leadership in the growing TAVR space.

Turning to Surgical Heart Valve Therapy product group, sales were up 8% on an underlying basis driven primarily by unit growth. This quarter's growth was strongest in the U.S. and Europe. Pricing remains steady globally with a modest increase in average selling price lifted by INTUITY, our rapid deployment valve.

In the U.S., surgical valves grew 11% this quarter. We believe there was increased growth in procedures overall and that we have regained share as customers returned after trying competitor products. In Europe, underlying sales grew 7% driven primarily by sales of our premium price INTUITY valve system.

To summarize, our surgical valve business in 2013 we are exiting with strong momentum and expect underlying sales growth in 2014 to be in the 4% to 7% range driven by additional traction in Europe of the INTUITY Elite and launches of new minimally invasive cardiac surgery products.

Now, turning to the Critical Care product group, total sales for the quarter grew 2% on an underlying basis. Growth was solid across most regions and product lines this quarter but was reduced by the impact of the China distributor inventory reductions and the ongoing exit of our ACCESS product line.

During the fourth quarter we were excited to obtain a CE Mark for ClearSight ahead of schedule. ClearSight is our integrated platform combining our noninvasive monitoring technology with our best-in-class EV1000 system. We think ClearSight will be a very attractive product for hospitals that are looking for a noninvasive technology to monitor their less critical patients. In 2014, we expect to build on our strong leadership position and deliver underlying sales growth of 3% to 6% aided by the launch of our new ClearSight product.

Before we get into the financials, I'd like to recap a few of the developments in our ongoing IP litigation. In the U.S. we announced last month a federal jury found that Medtronic willfully infringes one of our Cribier patents and awarded us $394 million in damages. We intend to ask the court to grant a permanent injunction. This patent is valid until the end of 2017.

Also in the U.S., we're still awaiting the court's decision related to the Andersen patent which also found Medtronic willfully infringes. We're seeking additional damages and a permanent injunction. Separately, we expect a decision by the U.S. Patent Office to be made in mid-2014 regarding the final patent term extension of this patent.

Edwards has invested significant resources developing products to help patients and we will continue to vigorously defend our intellectual property. Although the enforcement of our IP represents potential upside for our company, we've not included any benefit from patent litigation or royalties in our guidance.

Now, I'm pleased to introduce to you Scott Ullem, our new Chief Financial Officer, who joined us last month. Scott replaces Tom Abate who is retiring from Edwards after many years of service and dedication to our company for which we are truly grateful. Scott?

Scott B. Ullem

Thank you, Mike. I'll start by saying that I'm pleased to have joined Edwards. I've had a chance to meet some of our investors already and I look forward to getting to know many of you at upcoming conferences. I also want to thank Tom Abate for helping me make a smooth transition.

Now I'll turn it to our financial results. This quarter, our sales performance in valves allowed us to achieve diluted earnings per share of $0.68 and non-GAAP diluted EPS of $0.91 comparable to the fourth quarter of 2012, which benefited from large U.S. THV stocking orders.

Before I get into the details of the quarter, I wanted to elaborate on the sales return reserve that Mike referenced earlier. As we discussed during our Investor conference on December 9, as we launched SAPIEN 3 in Europe and SAPIEN XT in the U.S., we will exchange previously sold transcatheter heart valves to the more advanced technologies.

These planned product upgrades required us to record two reserves in the fourth quarter. First, a $14 million sales return reserve that reflects the value of the valves we already sold and will take back from customers. This reserve will reverse during 2014 as we ship the upgraded valves.

Second reserve is a small inventory reserve for returned product not expected to be resold. In order to compare our sales results on a consistent basis between periods, we are excluding the impact of the sales reserve both in this quarter and future quarters when the sales reserve reverses.

Now turning to the financials. For the quarter, our gross profit margin was 72.9% compared to 75.4% in the same period last year. The reduction was driven primarily by a reduced benefit from foreign exchange of approximately 130 basis points. The impact from the sales return reserve and higher manufacturing costs as we prepare for the SAPIEN XT launch in the U.S. and the SAPIEN 3 launch in Europe; these items were partially offset by a more profitable product mix. For 2014, we continue to expect our gross profit margin, excluding special items, to be approximately 73%.

Fourth quarter selling, general and administrative expenses increased to $191 million, up 7% over the prior year, driven primarily by the U.S. medical device tax and Japan transcatheter valve launch-related expenses. This was partially offset by favorable foreign exchange translation principally because the yen depreciated more than 20% year-over-year. We expect SG&A, excluding special items, to be between 37% and 38% of sales for the full year 2014.

Research and development expenses in the quarter grew 5% to $79 million or 15% of sales. This increase was primarily the result of continued investments in heart valve clinical studies. For the full year 2014, we continue to expect R&D as a percent of sales to be approximately 16%.

During the quarter, we recorded a $16 million pretax special charge comprised of two items; a global realignment charge of $10 million primarily related to severance expenses to improve Critical Care's operational efficiency. And second, a $6 million intangible asset write-off related to a prior acquisition.

Net interest expense for the quarter was $4 million. In the fourth quarter, Edwards issued $600 million, 2.875% coupon, five-year notes. We swapped 300 million of those notes to floating. For the full year 2014, we continue to expect net interest expense to be between $12 million and $15 million.

Our reported tax rate for the quarter was 25.3% or 23.7% on a non-GAAP basis. Assuming renewal of the federal research and development tax credit in the fourth quarter and excluding special items, we continue to expect our 2014 tax rate to be between 20% and 22%.

Foreign exchange rates negatively impacted fourth quarter sales by $13 million compared to the prior year, driven by the weakening of the yen. Compared to our recent guidance, FX rate negatively impacted earnings per share by $0.01. Looking forward at current rates, we continue to estimate $20 million negative impact to full year 2014 sales when compared to 2013 rates.

Free cash flow generated during the fourth quarter was $91 million. We define this as cash flow from operating activities of $111 million plus capital spending of $20 million. Excluding the $57 million impact from the Medtronic receipt for initial IP damages, full year free cash flow is $306 million which is our strongest performance ever.

Turning to our balance sheet, at the end of the quarter we had cash, cash equivalents and short-term investments of $937 million. Total debt is $593 million.

Now turning to our 2014 guidance. Our financial guidance remains unchanged from our December Investor conference. For Surgical Heart Valve Therapy, we expect sales to be between $810 million and $850 million. In transcatheter heart valves, we expect sales to be between $700 and $820 million, excluding the impact of the sales return reserve. And in Critical Care, we expect sales of $535 million to $575 million.

We expect full year total sales of $2.05 billion to $2.25 billion and free cash flow excluding special items between $325 million and $425 million. Excluding special items, we expect diluted earnings per share to be a wide range around $3. Given our planned share repurchases during the first quarter of 2014, we expect full year diluted shares outstanding to be between 107 million and 109 million.

For the first quarter 2014, we project total sales of 500 million to 550 million, excluding the impact of the THV reserve and diluted earnings per share, excluding special items, to be between $0.61 and $0.71.

With that, I'll hand it back to Mike.

Michael A. Mussallem

Thanks, Scott. Now, I'd like to provide an update on some of our product development programs. In transcatheter valves, we are continuing to actively work with the FDA to obtain approval of SAPIEN XT valve in the U.S. Consistent with our prior assumptions, we are anticipating approval over the next few months. Our SAPIEN XT which is currently the leading transcatheter valve in Europe will be a welcome upgrade for our U.S. physicians and patients and we anticipate a rapid adoption once it becomes available.

A few weeks ago you'll recall our announcement about the completion of the enrollment of the SAPIEN 3 trial for high risk and inoperable patients and the approvals to begin the study of 1,000 intermediate risk patients. The 500 patients in the high-risk arm were enrolled rapidly which demonstrates the enthusiasm clinicians have for our most advanced SAPIEN 3 valve and its smaller profile and a feature to address paravalvular leak.

Assuming a one-year follow-up and an uncomplicated FDA approval, we could expect U.S. approval by mid-2016. Enrollment of our 1,000 intermediate risk patients has already begun and we expect this study arm to enroll by the end of the year.

In Europe, we just received CE Mark for SAPIEN 3 and have commenced an aggressive launch with a number of successful implants already this year. Upgrading customers to this new platform should be fast as there is no need for extensive training and clinicians are very eager to get their hands on this exciting new technology. For these reasons, we believe SAPIEN 3 will quickly become the leading transcatheter valve in Europe.

We will soon be initiating enrollment in Europe of the next series of patients for our self-expanding CENTERA valve. CENTERA features a short, discrete frame, a novel motorized delivery system that allows for stable, precise deployment and is delivered through a 14-French eSheath. We continue to expect receipt of European approval in the mid-2015 timeframe.

Now, I'd like to provide an update on our Mitral Program. We continue to be excited about this significant opportunity that will be meaningful for patients, and believe that Edwards is well positioned, even as the path to commercialization may be long. We are disappointed that our first-in-human experience has not yet begun, as we are just now receiving the necessary regulatory approval to proceed. This has been the sole cause for the delay and we expect to begin shortly.

In our Surgical Valve product line, we're working closely with our notified body to gain CE Mark for our INTUITY Elite system and expect the approval soon. You will recall the increased reimbursement for our INTUITY valve is already in place in Germany.

During the Society of Thoracic Surgery meeting, data from the cadence trial demonstrated that INTUITY with an MIS approach significantly reduced cross clamp time and improved mean gradients when compared to a conventional open procedure. We continue to believe in INTUITY's potential for simpler procedures, fewer complications and faster recovery which supports our expectation for increased adoption of INTUITY in Europe in 2014.

In the U.S., enrollment in both our TRANSFORM trial for INTUITY and our COMMENCE trial studying the GLX tissue on aortic and mitral Magna Ease valves remain on track to be completed by the end of the year. GLX is our advanced tissue platform designed to enhance valve durability and enable pre-mounting of valves and delivery systems.

During the STS meeting, clinicians from the Cleveland Clinic presented a 30-year study of more than 12,000 patients who received our PERIMOUNT aortic valves representing over 81,000 patient years of follow-up. Of particular note were the durability outcomes showing a 98% freedom from explant for structural valve failure at 10 years and an 85% freedom of explant for structural failure at the end of 20 years.

Together with the two 25-year PERIMOUNT study presented in 2013, these data strengthening the differentiated body of scientific evidence demonstrating unmatched durability of the PERIMOUNT platform. Lastly, we continue to expect the introduction in 2014 of several minimally invasive enabling tools in our CSS product portfolio.

Finally, in our Critical Care product line, interest in noninvasive advancing monitoring remains high as clinicians apply this novel technology to surgical patients. We're just beginning our launch of ClearSight in Europe and continue to expect the U.S. launch in the third quarter of this year.

We're encouraged by the progress we're making with GlucoClear and the significant need for glycemic monitoring in the hospital setting. We're just now expanding our evaluations in Europe. Ultimately, the key to driving customer adoption will be the publication of outcomes and accuracy studies. These data will also help and form the pathway toward a U.S. approval.

So, in conclusion, we have a number of exciting products positioned to contribute to growth in 2014 and as we look beyond 2014, we like how we're positioned. Edwards is fortunate to have strong leadership and attractive markets with sustainable growth potential and a robust product pipeline which should enable us to strengthen our position even further and impact the care of more patients around the world. Combined with upside opportunities such as successful mitral therapies, glucose monitoring and patent enforcement, we believe that Edwards' future is very bright.

With that, I'll turn the call back over to David.

David K. Erickson

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 of these as we can during the remainder of the hour.

Operator, we're ready for questions please.

Question-and-Answer Session

Operator

Thank you. At this time, we'll be conducting our question-and-answer session. (Operator Instructions). Our first question is coming from the line of Mr. Raj Denhoy with Jefferies. Your line is now open. You may proceed with your question.

Raj Denhoy - Jefferies

Hi. Good afternoon. I wonder if I could ask – several things to ask. Maybe I can just start with the number of centers in the United States in the quarter, I think you noted it was 290 which was a nice tick up, and I'm curious if you have any thoughts around what's behind that, whether it's the availability of SAPIEN 3 in clinical trialing or perhaps hospitals getting more comfortable with profitability, maybe any thoughts should be helpful.

Michael A. Mussallem

Yes, thanks, Raj. Good question. I think it's just more of the same. There is continued interest on the part of hospitals; they've been wanting to get involved. They've all been looking very hard at how they can comply with the NCD and I think a number of them have just found a way to clear the hurdles. That's the primary driver.

Raj Denhoy - Jefferies

Okay. And maybe just for my follow-up, I know it's still very early days but Medtronic is now approved and coming here in the U.S. Any initial views on what they're doing in the marketplace? Have you seen anything yet ruining [ph] appetites there for you?

Michael A. Mussallem

Yes, there's not much to report at this point, Raj. I can't say that we have really felt the presence very much at this point, so we are very fortunate that we have this first-mover advantage and we like the clinical preference that we think is going to be there. And so we're feeling pretty good at this point. We're certainly ready for them.

Raj Denhoy - Jefferies

All right, good. I'll leave it there. Thank you.

Michael A. Mussallem

Thanks.

Operator

Thank you. Our next question is coming from the line of Mr. David Roman with Goldman Sachs. Your line is now open. You may proceed with your question.

David Roman - Goldman Sachs

Thank you. Good afternoon. I want to just come back to the return reversal question and make sure I fully understand what numbers you intend to report over the course of this year. So, as I look at the first quarter, the $500 million to $550 million number, can you give us some sense as to what the return reversal impact is going to be in Q1 and what number you actually expect to show up in street models?

Scott B. Ullem

Sure. Eventually all of the return reserve will be reversed. And I can't predict how much of that will happen in the first quarter versus in quarters beyond, but all of it will be reversed as products are exchanged.

Michael A. Mussallem

Yes, isn't it fair to say, Scott, that in that estimate we really have taken the reserves out of it? That's our estimate of what's going to actually happen and so you'll see that in our non-GAAP results, right, and that's what our guidance was about.

David Roman - Goldman Sachs

I'm sorry, I can take this offline later, but are going to be reporting non-GAAP revenue numbers for the fourth quarter – if I look at the gross profit, for example, the 72.9% that's calculated off of $550 million number or $536 million number?

Scott B. Ullem

Well, the 72.9% is calculated off of $536 million. We're going to be reporting GAAP and non-GAAP sales as we do for any special item in the first quarter and beyond.

David Roman - Goldman Sachs

Okay. I got it. And then maybe just a strategic question for you, Mike, as you sort of thought about the list of upside drivers that are not factored into your guidance, I think you said litigation, mitral, and glucose monitoring; all three which seem very far out, can you maybe just talk about how you see 2014 unfolding and what factors we can watch for to give clarity on a better outer year growth profile than what you're presenting for this year?

Michael A. Mussallem

Sure. We probably have some upsides that could show up in 2014. It could have to do with product approvals. There could be just continued data that continues to be presented from Edwards that's stronger than our competitors. But you're right in your observation that many of the upsides that I shared will occur possibly outside of 2014. In 2014, I think one of the things that will be most interesting is – and there's a little list here. One, within transcatheter heart valve, just how do we stack up competitively in Europe and in the U.S. So how does Edwards do with SAPIEN 3 versus the new competitors that are going to show up in the U.S.? How does Edwards do especially with SAPIEN XT versus our first competitor after a couple of years? And then that very nice momentum in surgical heart valves, how well does that continue? We feel like some of the factors were dragging the growth rate at Critical Care should be behind us to lift that growth rate. So I think there's a number of indicators to watch.

David Roman - Goldman Sachs

Okay. I'll get back in queue. Thank you.

Operator

Thank you. Our next question is coming from the line of Mr. Rick Wise with Stifel, Nicolaus. Your line is now open. You may proceed with your question.

Frederick Wise - Stifel, Nicolaus & Co., Inc.

Good afternoon, everybody. Mike, maybe you could talk a little bit more about the European launch of SAPIEN 3. You obviously expect considerable optimism, maybe a little more color or detail on the ramp. How quickly is it going to be available in the major centers? Is this a share gainer? Does it open new accounts? And maybe put that in perspective relative to the other product trials that are underway? Does it blunt the impact there? Just again, some of those details.

Michael A. Mussallem

Yes, we've got a pretty good supply out there and we're converting people right now. There's strong excitement and so people would like to go quickly. The features of this valve are something they find very attractive. In terms of will it be a share gain, in many accounts we are on the shelf with the competitor. So this is a chance for us actually for people to reach for SAPIEN 3 more often. So I think it does have an opportunity to have a share impact probably pretty early on here. We think it really is a best-in-class and we think once people try it that they're going to be excited about it. It's still early on, Rick, so it's tough to give you much than that but right now they're anxious to get their hands on it.

Frederick Wise - Stifel, Nicolaus & Co., Inc.

And it sounds like you're ready to supply. In the SAPIEN XT, I know it's always a difficult question but you said, 'expect approval in the next few months.' And I'm sorry to look for meaning where there may be some or none, but are you feeling more optimistic today versus your comments in the December approval – in the next few months feels more optimistic to me but maybe I'm looking for something that isn't there?

Michael A. Mussallem

I think it's similar, Rick. I mean we're just two months out from where we were before, so obviously here we are two months closer saying pretty much the same thing from a timing perspective. So I guess that does express some level of confidence. But yes, we're still feeling pretty good about that. But it is a regulatory process, so we're never positive just when that will come.

Frederick Wise - Stifel, Nicolaus & Co., Inc.

Okay, but it sounds like hopeful in second quarter.

Michael A. Mussallem

Yes, certainly.

Frederick Wise - Stifel, Nicolaus & Co., Inc.

Thanks.

Operator

Thank you. Our next question is coming from the line of Mr. Bruce Nudell with Crédit Suisse. Your line is now open. You may proceed with your question.

Bruce Nudell - Crédit Suisse AG

Good afternoon. Thanks for taking my question. Mike, when we think about the XT approval, should we be thinking about broad PARTNER I approval inclusive of inoperable and operable?

Michael A. Mussallem

Yes, we are hopeful that indeed when that approval comes we're working with FDA. We ask for both and we're hopeful that that's the way that it comes out. We think certainly that the data supports that, but we can't be sure.

Bruce Nudell - Crédit Suisse AG

And then one of the upstart competitors today announced the successful first in man in mitral. Could you just briefly explain the circumstances around your timing and maybe you also alluded in the fact that it's a long-term opportunity where commercial sales won't arise in the near term. Around what timeframe might we see successful commercialization of product?

Michael A. Mussallem

Well, as I said earlier, we expect to begin shortly. Our compliments to them if they really do have some early success here. We chose to do our first in human in places that have rigorous regulatory processes and we got some questions related to the preclinical data, but we believe we've answered all the questions and really do believe that we're going to begin shortly. So, we feel good about this. This is a big opportunity and we're anxious to get started to find out just exactly where we stand. I think the competitive landscape there is one that will unfold probably pretty deliberately over time. I think it's pretty tough to make a call where anybody is competitively at this stage of the game.

Bruce Nudell - Crédit Suisse AG

Thanks so much.

Michael A. Mussallem

Sure.

Operator

Thank you. Our next question is coming from the line of Mr. Jason Mills with Canaccord Genuity. Your line is now open. You may proceed with your question.

Jason Mills - Canaccord Genuity

Thanks, Mike and Scott, for taking the question. First question is on your EPS guidance. Mike, what are the top two or three variables that you need more clarity on to narrow that range? And when do you expect that that clarity might come? Will it be on the first quarter call, do you think it will take half a year, maybe just a little more color there?

Michael A. Mussallem

Yes, thanks, Jason. Probably the single biggest thing is going to be the approval of XT. Once we have clarity on the approval of XT in the U.S., that's probably the single outstanding variable. Second biggest to that is probably just – as we get more clarity on how our competitors are behaving and their launches in Europe and the U.S. and maybe we'll get a little bit more clarity than we have today. But the single biggest one will be that and I hope we have it under our belt by the time we get to the second quarter call. That will put us in a position to have a shot here and tighten things up.

Jason Mills - Canaccord Genuity

Okay, great. My follow-up again on transcatheter valves, sorry if I missed it Mike but did you give an ongoing procedural growth rate for you and for market in Europe, just trying to get a sense for what that's market doing with the next generation technology and sort of what you're expecting it do with SAPIEN 3, whether or not you expect to see an acceleration there? And then the U.S. follow-up on the first question, what's in your guidance – your THV guidance with respect to pricing if any changes is in there? Thanks. I'll get back in queue.

Michael A. Mussallem

All right, Jason, I'm going to make sure that I answer your questions accurately here as we go through it. So, first of all in Europe, what we specifically reported on was our OUS results. So OUS sales grew 28% and that was driven by very strong transfemoral growth. If you peel it back, I would say Europe grew in the low teens for us in 2013. And so we're pretty pleased with that. Well, I think when we talked about it going into the year, we were expecting a market growth of around 10 and our own growth to be less than that because of competitive reasons and we certainly came out much stronger, some of this driven by the real momentum that we have in the fourth quarter. So that's broadly where that stands. I don't know if that answers your question. I expect there to be pretty good growth in 2014 as well. I don't know, I would hope that it might be in the 10% range. As it relates to pricing, we think our pricing has been pretty solid. We have noted in the past that we had an ASP decline, was probably in the 3% range, probably driven mostly by the volume discounting we do. With the advent of SAPIEN 3 we expect to be able to introduce those products at the same price as SAPIEN XT. So, I think you should think that pricing is going to stay pretty stable in 2014.

Jason Mills - Canaccord Genuity

Thanks, Mike.

Michael A. Mussallem

Sure.

Operator

Thank you. Our next question is coming from the line of Danielle Antalffy with Leerink Swann. Your line is now open. You may proceed with your question.

Danielle Antalffy - Leerink Swann LLC

Thanks so much. Good afternoon, everybody. Just a quick question on valve sizing, I understand with SAPIEN XT you'll get I believe it's the 29 millimeter valves. That helps fill out the sizing, makes you more competitive with CoreValve. How much does that increase the addressable market from a patient perspective in your view? And then how much of the market will you still not be able to address versus your competitor, CoreValve?

Michael A. Mussallem

Yes, the 29 millimeter valves in our view is very meaningful. I think if you think back to the days when we first introduced it in Europe, we saw a real uptick. We got it first in the transapical position then transfemoral and that ticked off. And then we – it feels like a lot of the share that we're gaining in Europe right now is in the 29 millimeter sizes. It seems to stack up pretty well competitively. So, I don't know exactly what that percentage is. It probably is in the sort of – I don't know, plus 20% probably in the 29. But I'd say the majority of patients get covered between 23 to 29, we'd estimate that close to 95% of the patients are addressed.

Danielle Antalffy - Leerink Swann LLC

Okay, got it. And Mike not to harp on mitral, but you've given a little bit of color in the past when we come to visit you on how you guys are thinking about the mitral timeline as far as getting from first in man to commercialization. Are you still thinking that despite the delay, it's possible to tighten up that timeline versus what we saw with first generation SAPIEN here in the U.S. or is the sort of 7 to 10-year timeline sort of what we should be thinking about?

Michael A. Mussallem

Yes, Danielle, I don't know how to sort of explain this more clearly. We're really excited about mitral. It's a really big opportunity. We're beautifully positioned but it is really hard to put timelines on it at this stage of the game. We really don't have our first in human experience underneath our belt. And until we see what that looks like, we're just not going to know what kind of timeline. You could think optimistically that if everything is perfect then you just keep going right to CE Mark, but you very easily could be in a redesign as well and we just don't know the answers to those questions yet. So, I think it's premature, Danielle, to dial in too many specific sales here in the near future.

Danielle Antalffy - Leerink Swann LLC

Okay, got it. Thanks, guys.

Operator

Thank you. Our next question is coming from the line of Brooks West with Piper Jaffray. Your line is now open. You may proceed with your question.

Brooks West - Piper Jaffray

Thanks for taking the question. Mike, can you remind us what your ASPs are for SAPIEN 3 in the clinical setting in the U.S.? So in another way, if you're going to do 1,000 patients this year, what should we look at for U.S. clinical revenues?

Michael A. Mussallem

Yes, I think in most of our contracts where we price our clinical units around $25,000, Brooks, if that helps.

Brooks West - Piper Jaffray

Okay. Perfect. And then one on Japan, you did 4 million you said in Q4 maybe being slowed down by the certification process. I think Larry said at the analyst meeting that you would do 40 to 50 next year in Japan. Does that still seem achievable and then does that become pretty backend loaded?

Michael A. Mussallem

You know what, it feels to us that Japan is right on track, just exactly what we expected. As I noted, there is this certification requirement so we're thinking right now that we're going to get limited to adding four accounts per month. So from that perspective, yes, it's backend loaded. But we feel good about the $40 million to $50 million range. That range is tracking at least with the experience we have so far which is I guess four months under our belt. It looks like it's just stacking up just the way we thought it would.

Brooks West - Piper Jaffray

Great. Thanks, Mike. Welcome onboard, Scott.

Operator

Thank you. Our next question is coming from the line of Lawrence Biegelsen with Wells Fargo. Your line is now open. You may proceed with your question.

Lawrence Biegelsen - Wells Fargo Securities, LLC

Thanks for taking my question. Let me start, Mike, with comments you made earlier about clinical data that may help differentiate you from the competition in 2014. Can you talk about that a little bit? And specifically we were intrigued to see this head-to-head study called the CHOICE study from Germany being presented as a link breaker at ACC. Was that what you were referring to? Do you think that study has taken off to impact share? And I had one follow-up. Thanks.

Michael A. Mussallem

We continue to be surprised with the data that's being collected out there. There are country registries that are going on. This study that you referenced coming out of Germany that's going to be presented at the ACC is one that's going to be interesting and we don't know the results of that. And there's also quite a bit of data that's being presented now in the surgical space. Some good stuff for us and some things that aren't necessarily complementary for some other valves of our competitors. So broadly we think we're on pretty solid ground here and like to think that the more that our products are studied, the more that – the best of Edwards is going to show. But I wasn't trying to refer just to that study in Germany at the ACC, because we really don't know the outcome but we're optimistic about it.

Lawrence Biegelsen - Wells Fargo Securities, LLC

Mike, I just wanted to ask my follow-up question on the U.S. TAVI market. If we look at your sales excluding stock in the last three quarters, it's been in the $88 million to $91 million range. It's been flattish if I'm doing the math right. And so if we take stocking out, you did about 345 million in the U.S. this year. Why do you think it's been flattish sequentially the last three quarters? And what are you looking for in 2014 at this point for the U.S. market, ex-stocking? You can put clinical in because I think that it's probably valid but help us think about the market growth for the U.S. in 2014 including CoreValve? And I'll drop. Thanks.

Michael A. Mussallem

Yes, just a couple of things. One is, the fourth quarter was pretty consistent with what we thought it was going to come out to be. I think when we provided our guidance, we said it was going to be at the low end of the range that bottomed to 350 and pretty much came out that way. Some of it probably just has to do with the limitations of SAPIEN. This is a pretty big valve, Larry. It's a 24 French system that we think as you have systems that are earlier to handle, it's going to be better for patients and better for clinicians and we think that will certainly help. There was more to your question, I'm sorry…

Lawrence Biegelsen - Wells Fargo Securities, LLC

Yes, expectations for market growth in 2015. On an apples-to-apples basis if you want to just include clinical, strip out stocking, whatever you feel is most helpful to give us some direction…?

Michael A. Mussallem

Yes, we at the investor conference, we estimated that the global growth in 2014 for THV would be in the 20% to 30% range. We didn't give an estimate for the U.S. and I think that just reflects some of the uncertainty associated with these approvals. But I do think that as systems that can go through an 18 French Introducer come out there that it's going to help the growth rate in the U.S. market.

Lawrence Biegelsen - Wells Fargo Securities, LLC

Thanks for taking the questions.

Michael A. Mussallem

Sure.

Operator

Thank you. Our next question is coming from the line of Mr. Ben Andrew with William Blair. Your line is now open. You may proceed with your question.

Ben Andrew - William Blair

Good afternoon, Mike. May be just a quick question about the efforts to go back and work with clinics to improve their economics. Have you seen any traction in a subgroup of clinics yet, and how do you expect that to play out through the course of the year? And what impact does that have on your range of guidance?

Michael A. Mussallem

Thanks, Ben. We're optimistic about this one. We have seen improvements. We think there are sites right now and the biggest improvements that we know are in their lengths of stay. They've gotten in many cases motivated about this. They're talking about it. They're sharing best practices and they're moving the needle. I wouldn't be surprised to see more and more presentations in the future about how people are reacting. We hear about things anecdotally that are pretty impressive. And so we like the things the way things are moving right now, Ben. There's substantial movement from a year ago today.

Ben Andrew - William Blair

Okay. And then changing gears quickly, on the request for an injunction in the U.S., given kind of the domestic focus on patient access or patient harm potentially and the design differences, I know you're not going to characterize the percent as odds of this but is it actually likely that you can get an injunction from the courts in the United States like in Germany?

Michael A. Mussallem

Yes, it's a good question, Ben. One of the things that I think any judge would worry about is whether somehow patients were going to be denied therapy because of implementing an injunction. And one of the things that we would do is to certainly consider having appropriate carve-outs that protect patients, so that no patient is ever in a position where they have to worry about getting therapy because an Edwards' product doesn't suit their needs. And we think if we take that kind of a stance it only makes it a little easier for the judge here to draw a conclusion that an injunction is appropriate.

Ben Andrew - William Blair

Thank you.

Michael A. Mussallem

But I'll also say that if something like that were to happen, it's certainly an upside and it's not in our plans today.

Ben Andrew - William Blair

Right, thank you.

Operator

Thank you. Our next question is coming from the line of Kristen Stewart with Deutsche Bank. Your line is now open. You may proceed with your question.

Kristen M. Stewart - Deutsche Bank AG

Hi. Thanks for taking the question. I just wanted to go back to the reserve adjustments, just understanding how you guys are presenting it through the non-GAAP figures. Mike, I think you had mentioned just for transcatheter valve 93 million in the U.S., is that excluding the reserve? Maybe you can just give us what the reserve breakdown in terms of U.S. and OUS? I'm assuming you guys are adding that back to the sales line and then adding it back I guess to cost of goods? I'm just a little confused on the accounting there.

Scott B. Ullem

Sure. It was a $14 million reserve roughly split between the U.S. and Europe.

Kristen M. Stewart - Deutsche Bank AG

Okay. So, Michael, the U.S. sales of 93 million were adding back roughly I guess 7 million to the reported GAAP results of a sales basis?

Michael A. Mussallem

So I think 93 excludes the reserve, Kristen. So it doesn't count that.

Kristen M. Stewart - Deutsche Bank AG

Okay. And then what specifically I guess was written off, you had mentioned there was in process R&D charge that was excluded out as well. So I guess what does that relate to?

Michael A. Mussallem

There was an investment – actually some of you may recall, it goes back to Embrella. We took a slight impairment associated with that purchase that we did. I don't know that must be two years ago now.

Kristen M. Stewart - Deutsche Bank AG

Okay. Is that written-off because you guys are not pursuing that technology or it's just not going to come at the maybe sales contribution that you thought before?

Michael A. Mussallem

I think our belief is that it's a smaller opportunity than was in our original business model and that causes us to modify its value.

Kristen M. Stewart - Deutsche Bank AG

Okay. And then last question, any I guess change and thoughts just about cash usage. I know you guys have the share repurchase program outstanding, but any thoughts just on the share considering a dividend or just acquisitions to maybe diversify the sales profile?

Scott B. Ullem

Kristen, really no change in priorities for cash at this point.

Kristen M. Stewart - Deutsche Bank AG

Okay. Thank you.

Operator

Our next question is coming from the line of Mr. Glenn Novarro with RBC Capital Markets. Your line is now open. You may proceed with your question.

Glenn Novarro - RBC Capital Markets

Thanks. Good afternoon. Just one follow-up on mitral, just wanted to confirm the first in man is still going to be a transapical. And if so, can you give us any update on a transfemoral approach?

Michael A. Mussallem

You're right, Glenn. There is no change in what we said at our investor conference. It's the device we talked about and yes, it's a transapical delivery system. It's still large bore. Yes, our longer term plans are certainly to want to move this to a transfemoral which would mean transseptal delivery but there is some work to do and we really want to have our first in man experience before we can really give you more specifics on that one. But that would really help unlock the long-term potential. But it's kind of premature right now. We just want to right now have a successful experience and be able to look back after 30 days and say that we've got a valve that's functioning the way it needs to.

Glenn Novarro - RBC Capital Markets

And then a follow-up, you didn't give us the timeline for PARTNER 2a. I think the last patient came in last summer, two years of follow-up. So do we see those results toward the end of 2015?

Michael A. Mussallem

Yes, I'm trying to recreate it here. I think P2a – remember that has a two-year endpoint, so – let's see. I don't know, David, do you recall when we – it was September, October. Then you've got two years following that, Glenn. Does that answer your question…?

Glenn Novarro - RBC Capital Markets

Yes, I'm assuming there we get that data TCT or AHA of 2015 toward the end of 2015. Is that reasonable?

Michael A. Mussallem

Yes. You know what, I didn't do the math on that one but I can get back to you on that. But yes, it usually takes us – once we actually hit that two-year endpoint, it usually takes us a good quarter, maybe a little more before we can put the data together and have it ready for publishing and have it out there.

Glenn Novarro - RBC Capital Markets

Okay, all right. Thank you.

Michael A. Mussallem

Sure.

Operator

Thank you. Our next question is coming from the line of Mr. Mike Weinstein with JPMorgan. Your line is now open. You may proceed with your question.

Michael Weinstein - JPMorgan Chase & Co.

Thank you. Mike, I think the last patient follow was early October. So I would assume ACC at '16. Let me make sure I'm clear on the reversal for the reserve. Having covered stent companies for years, we've seen reversals before. But I don't think we've seen a company reverse the bottom-line impact. So I just want to make sure I understand how you're going to be treating that going forward. So we see a negative impact from these reversals on EPS where your GAAP to non-GAAP adjustments over the course of this year being negative relative to the positive adjustment that occurred in the fourth quarter?

Scott B. Ullem

Sure. Mike, it's Scott. Most of the impact of the reversal comes at the gross profit line and the operating profit line and it all flows right down to that $0.10 a share in diluted EPS.

Michael Weinstein - JPMorgan Chase & Co.

Yes, I understand that. So you credited the 2013 P&L with $0.10 for product that you sold but didn't implant. And so as you go back with new product that you're going to sell again, and then you're going to do what on the EPS line? So what's the bridge going to be from GAAP to non-GAAP in '14 since you just added back that $0.10 in '13?

Scott B. Ullem

We're going to pull it out in both years. Our intention is to reflect the impact of what the business would look like if we didn't have the swap and what the impact of the business looks like with the swap.

Michael A. Mussallem

This is Mike. It's always risky when I get in here and answer financial questions, but what was sold in the fourth quarter is really what was sold. And it's typical sales. What the accounting convention we understand is if you believe that there is going to be this sort of exchange in the future, you pull it out of today's sales. And then when that actually goes back and you put it back in, but that would just confuse our presentation of results. And so that's why we're going to end up showing this both ways here. We're going to pull this exchange out and show you what it is discretely both this year when we're taking the downer and next year when it comes back and it's the upper, we'll also take it out.

Michael Weinstein - JPMorgan Chase & Co.

Okay. So you'll take the EPS contribution from '13 out of '14, if we're all supposed to be using non-GAAP numbers here?

Michael A. Mussallem

Yes, top to bottom, Mike, it all comes out.

Michael Weinstein - JPMorgan Chase & Co.

Okay. And then one question; the first quarter guidance, how do you get to the lower half of that range? It would seem if the roughly $3 is the guidance for '14, obviously recognizing that's a very much a ballpark figure, it would seem that guiding from down 2% to down 16% in EPS, the down 16% type number would seem to be extreme given that the first quarter the competitor launching. So how do you get to – how would you get to the lower half of that range in the first quarter?

Michael A. Mussallem

I don't know. Mike, there's a wide range. What we've tried to do is to represent what we think the full range of possibilities are and this is sort of I suppose the bottom of the range is just a lot of things go wrong and top of the range, so a lot of things go right. I mean I'm not going to lay out detail specifics on that, but at this stage when there was the uncertainty associated when Edwards is going to be approved and the uncertainty of exactly how the rest of the questions about the rollout of competitor products exists, we thought it was best to give you what our feeling was as a realistic wide range.

Michael Weinstein - JPMorgan Chase & Co.

Okay. Thanks for taking the questions.

Michael A. Mussallem

Sure.

Operator

Thank you. Our next question is coming from the line of David Lewis with Morgan Stanley. Your line is now open. You may proceed with your question.

Steve Beuchaw - Morgan Stanley

Hi. Good afternoon. It's Steve Beuchaw here for David. First of all, Scott, welcome to the call.

Scott B. Ullem

Thanks, Steve.

Steve Beuchaw - Morgan Stanley

Two quick ones. One is on SAPIEN 3, the full CE Mark study data, could you give us a sense of when we might expect to see that data and is it safe to say that expectations for best-in-class leak data, low stroke appropriate there?

Michael A. Mussallem

Well, in terms of when it's going to be available, we say most likely at PCR. That would be our estimate although again these clinicians tend to operate pretty independently. We can't speculate exactly what it's going to say but the enthusiasm's been high and we're thinking that the results are going to look pretty positive based on what we've seen in the very early data?

Steve Beuchaw - Morgan Stanley

Got it. And then one on the U.S. market, Mike, in your comments thinking back to TCT and the analyst day, you sounded very comfortable with a view that pricing in the U.S. would be, let's call it, disciplined. Is there any higher or lower level of comfort that you're feeling now that you've seen the competition on the market in the U.S. as it relates to where pricing trends?

Michael A. Mussallem

Yes. Thanks, Steve. It's going to be interesting for us. We just take what we've heard externally. The same maybe that you've heard is that we don't expect there to be a dramatic change in the pricing of our competitors what we really don't know. We're not anticipating that there's going to be a big change in pricing. Remember, there was a very large investment on the part of anybody to get to the U.S. market. This would only be the second competitor in the U.S. market and there's nobody on the near horizon that would be coming to the market. So, I don't know if there's a lot of incentive to change pricing dramatically.

Steve Beuchaw - Morgan Stanley

Thanks, very helpful. Have a great afternoon.

Operator

Thank you. Ladies and gentlemen, due to time constraints we'll be only able to take one final question. Our final questioner will be Bob Hopkins of Bank of America Merrill Lynch. Your line is now open. You may proceed with your question.

Robert Hopkins - Bank of America Merrill Lynch

Great. Thanks for squeezing me in. I appreciate it. So just two quick ones. First of all, Mike, in your prepared comments you talked a lot about how ready the organization is for the CoreValve launch. And I was wondering if you could add any color to that in terms of how do you defend against CoreValve? What is the strategy? Any details you'd be willing to provide there would be helpful.

Michael A. Mussallem

Yes, thanks very much, Bob. I'm not sure that I want to go into detailed tactical approach but other than say that we think the body of evidence that's around SAPIEN and especially SAPIEN XT provides a tremendous foundation for which we can compete. And when you combine that with our willingness to upgrade people from SAPIEN to SAPIEN XT in a pretty painless and rapid fashion, we think it puts us in a position to be very strong defensively. As you know from our P&L, we were continuing our spending rate in terms of our sales and marketing resources in the U.S. We haven't pulled back on that at all. And simply the fact that we have a full mover advantage in that we've been in the marketplace for a couple of years, we like to think we've treated our customers with a lot of respect and a lot of care, we think that is only helpful at a time like this when they're going to have a choice.

Robert Hopkins - Bank of America Merrill Lynch

Okay. Thanks. I understand the rationale for not disclosing too much there, but just curious if you wanted to add anything. And then the second question was on the European market for TAVR, and just if you could provide a little bit more color on why you think it did better than you originally anticipated? And are there any read-throughs there for the U.S. market long-term? Just trying to understand why the better growth in Europe.

Michael A. Mussallem

Yes, I mean it was very encouraging from our point of view. I'm not sure that we really saw it. There were a couple of things that I thought were noteworthy. One is that we saw it – we've typically seen Germany grow nicely and that continues to be a nice part of our growth, but we watched France and Italy and the UK all put up improved growth numbers. And so that was meaningful to us. From a share perspective, we performed very well in transfemoral units. I mean this was very strong growth. And again, it seems that the 29 millimeter XT is continuing to be a very popular product with customers. So I guess that's all I'd really add. Southern Europe was gone from being drag to growing again. May be that's part of it as well, Bob.

Robert Hopkins - Bank of America Merrill Lynch

Great. That's helpful color. Thanks so much.

Michael A. Mussallem

Sure. Okay. Well, thank you all for your continued interest in Edwards. Scott, David and I welcome any additional questions by telephone.

So with that, back to you David.

David K. Erickson

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 #13574369. Let me repeat this numbers. Dial (877) 660-6853 or (201) 612-7415 and the conference #13574369. In addition, an audio replay will be archived on the Investor Relations section of our website. Thank you very much.

Operator

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

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