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Executives

David Erickson - VP, IR

Michael Mussallem - CEO

Thomas Abate - CFO

Analysts

Bruce Nudell - Crédit Suisse

Tom Gunderson - Piper Jaffray

Bob Hopkins - Bank of America

Amit Balla - Citigroup

Raj Denhoy - Jefferies & Co.

Glenn Novarro - RBC Capital Markets

Larry Biegelsen - Wells Fargo

David Roman - Goldman Sachs

Kristen Stewart - Deutsche Bank

Michael Weinstein - JP Morgan

Jason Mills - Canaccord

Spencer Nam - ThinkEquity

David Lewis - Morgan Stanley Smith Barney

Edwards Lifesciences Corporation (EW) Q1 2012 Earnings Call April 24, 2012 5:00 PM ET

Greetings, and welcome to the Edwards Lifesciences Corporation’s first quarter 2012 earnings conference call. [Operator instructions.] It is now my pleasure to introduce your host, David Erickson, vice president of investor relations. Thank you, Mr. Erickson, you may begin.

David Erickson

Welcome, and thank you for joining us today. Just after the close of regular trading, we released our first quarter 2012 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 Tom Abate, CFO.

Before I turn the call over to Mike, 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 and sales growth, gross profit margin, net income growth, earnings per share, SG&A, R&D, tax rates and free cash flow, diluted shares outstanding, foreign currency impacts, operating margin, and other financial expectations, including our assumptions regarding the timing and extent of the additional U.S. approvals, launches, and reimbursement for the SAPIEN Transcatheter Heart Valve.

These statements also include our current expectations for regulatory submissions and approvals related to a variety of new products and indications in the U.S., Europe, and Japan, as well as the timing, status, and expected outcomes of new or currently ongoing clinical trials; the expected impact, benefits of, and market potential for new product introductions; expectations regarding market growth; and potential impacts of economic conditions and competitive products.

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, 2011, 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.

Now I'll turn the call over to Mike Mussallem. Mike?

Michael Mussallem

Thank you David. This quarter was highlighted by an impressive first quarter of SAPIEN commercialization in the United States. Additionally, we’re pleased that the growing body of longer-term evidence further supports the Edwards SAPIEN transcatheter valve as an important therapy. And, with a scheduled FDA panel for cohort A and our approaching national coverage decision, the near term U.S. transcatheter opportunity will become more clear.

At the same time, given current dynamics, which we’ll discuss shortly, we are tempering the full year forecast for THV sales. And although we are lowering our overall 2012 expectations, excluding special items, we continue to expect underlying sales growth to be approximately 20% and earnings per share growth of 30%.

Before turning to the quarterly results, as a reminder, this year we’ve begun reporting sales in three new product groups: surgical heart valve therapy, which combines surgical heart valves and cardiac surgery systems; transcatheter heart valves and critical care, which includes vascular.

Reported sales grew 14% to $459 million, primarily driven by the U.S. launch of SAPIEN. On an underlying sales basis, they grew 13%. Sales outside the U.S. grew 7% on a regular basis, and represent approximately 60% of total sales.

For the first quarter, the surgical heart valve therapy product group grew 3% to $204 million, which included $28 million from cardiac surgery systems. Within this product group, surgical heart valves grew 2% over last year. Outside the U.S., our surgical heart valves grew 7%, driven primarily by penetration of our premium products in Europe and Japan.

Product pricing remains stable in each region. However, strong growth in emerging markets changed the country mix, which slightly lowered our overall global average price. In the U.S., the continued impact of a competitor’s product introduction last year led to a modest decline in surgical heart valve sales this quarter. In the second half of 2012, we expect the impact to diminish as the competitive introduction annualizes.

In Europe, we believe we gained share through the growth of our premium products. In Japan, we’re pleased that our Magna Mitral Ease valve was approved in the first quarter, and customers are actively converting to this state-of-the-art mitral valve. Recently, a competitor received an earlier than expected approval of an aortic pericardial valve. We expect these impacts in Japan to be somewhat offsetting for the remainder of the year.

We continue to make good progress on our pipeline and are excited about the promise of these technologies. As previously announced, during the quarter we received CE mark for our Edwards INTUITY rapid deployment aortic valve system. As expected, we are initiating our CADENCE and Foundation European post-approval studies focused on the patient benefits and health economics of this new procedure compared to traditional open heart surgery. With this focus on clinical studies, we expect the INTUITY revenue contribution in 2012 to be modest, and to begin contributing to growth next year.

Additionally, in Europe, we are enrolling in TRITON II, a clinical study of our next-generation INTUITY system, which features enhancements to both the delivery system and the valve. And for our next-generation tissue technology, GLX, we now expect to receive a CE mark in the second quarter of this year.

In the U.S., we continue to expect an IDE approval by mid-year for an INTUITY clinical trial called Transform. At the upcoming AATS meeting, we expect several data presentations on Edwards innovations, including updated data from our TRITON European clinical trial for INTUITY.

Cardiac surgery system sales for the quarter were $20 million, up 5% on a reported basis, and an underlying basis. This growth was driven by our MIS portfolio and our base cannula products. As planned, in the first quarter, we initiated a limited launch of our IntraClude aortic occlusion device, which is designed to facilitate MIS mitral valve surgery.

Initial feedback has been positive, and we expect to broaden the launch in the second quarter. Our ProPlege retrograde cardioplegia device, designed to protect the heart during an MIS procedure, is on track for a limited launch later in the second quarter.

In summary, for 2012, we continue to expect to achieve underlying sales growth of 3-5% in the surgical heart valve therapy product group, driven by continued momentum of our newest products.

Turning to transcatheter heart valves, first quarter sales were $122 million, a 67% growth rate over last year, driven by the U.S. launch of SAPIEN, with sales of $41 million. Outside the U.S., underlying sales grew 20%, and were somewhat tempered by market dynamics in Europe and the $2-3 million in 29 mm stocking orders last year.

Overall, pricing remains stable. Transfemoral systems represented approximately 70% of our global sales, lifted by the U.S. commercial ramp, which is entirely transfemoral.

Our growth in southern Europe was negative again this quarter, driven primarily by economic conditions. While we’re not predicting an economic improvement in 2012, we do expect our new product introductions to turn growth positive in the second half. And even with the economic conditions in southern Europe, we anticipate Europe will grow at a robust rate of 20-25% this year.

With the anticipated mid-year launch of our 29 mm SAPIEN XT for transfemoral delivery, we expect to gain additional share. We’re also look forward to the planned mid-year launch of Ascendra Plus, which gives us an improved transapical delivery and expected indication for transaortic delivery. We are the clear market share leader in Europe in transcatheter heart valves, and with these new product introductions we expect to strengthen our position.

There have been some recent developments with European reimbursement. In France, the expected expansion in the number of hospitals approved to perform TAVR procedures was delayed. On a positive note, new guidance was issued in late March by the NHS in the U.K., which now recommends the use of TAVI for inoperable patients. We’re already seeing the positive effects of this decision.

Turning to the U.S., we’re very pleased to report that the total U.S. sales for our first full quarter of launch was $41 million, which included approximately $7 million of clinical sales. Of the $34 million in commercial sales, reorders, driven by higher than expected procedure volume, drove results, with only about 30% coming from stocking units.

Since the November launch, we’ve trained approximately 60 centers. Reimbursement uncertainty has caused some centers to postpone their training and others to delay procedures. However, physician and hospital interest in our SAPIEN program remains very high, and we still expect to train 150-250 new commercial sites in the first 12 months.

As we’ve previously stated, maintaining a high level of acute procedural success is our first priority, and continues to drive the pace of our SAPIEN rollout. We are very pleased with the high success rate that has been achieved.

In early February, CMS issued a draft proposal for its National Coverage Analysis for TAVR, and we submitted a formal response in early March. We continue to expect CMS to announce its final NCD in early May. We’re pleased that the majority of regional Medicare contractors have continued to reimburse SAPIEN procedures on a case-by-case basis.

Recently, new CPT physician payment codes for transcatheter valve procedures were approved, which becomes effective in January of 2013. It’s worth noting that these new codes will include additional reimbursement in recognition of the importance of having more than one physician in these procedures.

At ACC last month, data from the high-risk cohort A of the PARTNER trial were presented, and concurrently published in the New England Journal of Medicine. The authors concluded that the two-year follow up supports the use of TAVR as an alternative to surgery in selected high-risk patients with aortic stenosis.

As we announced a few weeks ago, the FDA advisory panel for cohort A is scheduled for June 13. We had assumed an earlier panel date, and while we’re disappointed by this one quarter delay, we are working constructively with the FDA. We remain confident that the advisory panel will acknowledge that the trial results clearly demonstrate the benefits of both TA and TF as less-invasive treatment options for high-risk surgical patients.

Turning to our PARTNER II clinical study, which is evaluating our SAPIEN XT technology, we are in the follow up phase of cohort B, which studies inoperable patients and continue to plan for a U.S. approval in 2014. Cohort A, the surgical arm, is studying up to 2000 patients with a lower risk profile than those in the PARTNER trial. Enrollment is well underway at approximately 25 centers, and we still expect to complete enrollment in 2013.

In Europe, we continue to anticipate starting clinical trials in 2012 for two important new transcatheter valve platforms that we believe will enable us to reach more patients and further extend our leadership position. SAPIEN III is our next-generation balloon expandable valve that builds on all our knowledge and experience, and includes a unique feature designed to reduce perivalvular leak.

CENTERA, our repositionable self-expanding valve, features a motorized delivery system designed for a stable deployment and single operator use. The most notable aspect of both systems is that they are low profile and delivered through a 14-French e-sheath. Early first-in-human experiences on SAPIEN III and CENTERA are scheduled to be presented next month at EuroPCR. Also at that conference, contemporary 30-day SAPIEN XT data will be presented from over 2,000 patients whose enrollment was completed late last year. In Japan, we remain on track for an expected regulatory approval of SAPIEN XT in 2013.

We are initiating our pro-TAVI trial to study the causes of stroke and evaluate our umbrella device and expect to begin enrolling in the second quarter. The results of this study should become available later this year, and could support a 510k for umbrella in the U.S.

With respect to our THV patent litigation with Medtronic Core Valve, we continue to expect a decision by the U.S. Court of Appeals by mid-2012.

In summary, for 2012 we are lowering the range of our expected overall THV sales by $30 million. There are three components to this change, including the one-quarter delay in the expected approval of SAPIEN for high-risk surgical patients in the U.S., the market dynamics in Europe, and the effect of current foreign exchange rates.

We now expect $200-240 million of clinical and commercial sales in the U.S. The stronger procedural growth we are currently experiencing is expected to somewhat offset the anticipated one-quarter delay for the cohort A approval.

For the full year, we now expect THV sales in the range of $530-600 million, and an underlying growth rate over last year that is likely to exceed 70%.

Turning to the critical care product group, total sales for the quarter were $134 million, which included $12 million from vascular products. Within the product group, critical care sales were $122 million for the quarter, up 1% on a reported basis. More than $4 million of discontinued product reduced growth by about 4%.

Sales growth in the first quarter was driven by advanced monitoring products in Europe and the U.S., offset by the discontinued products and the strong prior year results in Japan. Our newest products, EV 1000 and Volume View, continue to gain acceptance. We look forward to introducing the next generation globally in mid-2012, particularly in Japan, where we expect these products to have significant impact.

With respect to our glucose program, in the first quarter we completed the first phase of our GlucoClear clinical evaluation in Europe, and we are encouraged by the accuracy results and positive clinician feedback. We continue to expect a CE mark before the end of 2012 on an enhanced system.

Total reported vascular sales, which is comprised of our Fogarty products, were $13 million this quarter, down slightly from the prior year. For 2012, we continue to expect full year underlying sales growth for the critical care product group of 5-8%, with important contributions from Asia and the launch of our next-generation EV 1000 platform.

And now I’ll turn the call over to Tom.

Thomas Abate

Thanks Mike. This quarter, our strong sales performance, driven by the U.S. launch of SAPIEN, allowed us to achieve diluted EPS of $0.55 and non-GAAP diluted EPS of $0.53, which exceeded the top end of our guidance.

With significant transcatheter investments and SG&A already in place, we expect our operating margin to improve significantly as sales rise. However, as Mike mentioned, due to a number of factors, we have reduced our full year projected sales for transcatheter valves, which is the driver of our $0.12 reduction to full year estimated diluted EPS.

For the quarter, our gross profit margin was 72.3%, compared to 71.1% in the same period last year. This improvement was driven primarily by a more profitable product mix. For 2012, we continue to expect our gross profit margin to build throughout the year as THV sales grow. For full year 2012, excluding special items, our guidance remains between 73% and 75%.

First quarter SG&A expenses were $177 million, or 38.6% of sales, an increase of 18% over the past year. This increase was driven primarily by U.S. transcatheter launch-related investments. We continue to expect SG&A to be between 36% and 39% of sales for the full year. As a percentage of sales, SG&A should trend down during the year.

R&D investments in the quarter grew 16% to $69 million, or 15% of sales. This increase was primarily the result of additional investments in clinical studies and new product development efforts in our transcatheter valve program. For the full year 2012, we continue to expect R&D as a percentage of sales to be between 14% and 15%.

Our reported tax rate for the quarter was 23.9%, lower than expected due to the release of reserves related to a pending settlement. Without the specific benefit, our rate was 26.6%. Excluding special items, we expect our rate to be approximately 27% for the next two quarters, and drop to approximately 22% in the fourth quarter, due to our anticipation of the federal R&D tax credit renewal.

FX rates did not have a material effect on either sales or earnings in the quarter. Looking forward, if rates remain unchanged, the picture changes substantially, resulting in a $45 million negative impact to full year sales compared to last year.

Free cash flow used during the quarter was $49 million. We define this as cash flow used in operating activities of $31 million, plus capital spending of $18 million. While it’s not unusual for our first quarter cash flow to be negligible, this quarter’s outflow resulted primarily from $38 million of anticipated annual excess tax benefits from stock plans, which was fully recorded in our first quarter. For full year 2012, excluding special items, we continue to expect free cash flow to be between $240 million and $260 million.

During the quarter, we spent approximately $100 million on share repurchases, which includes $54 million for an accelerated share repurchase program. We received approximately 80% of the shares under this program in the first quarter, and will receive the balance in the second. For modeling purposes, we now project fully diluted shares outstanding to be 118 million in 2012.

Turning to our balance sheet, we had total cash and cash equivalents and short term investments of $410 million, and total debt of $179 million. Short term investments were $196 million, and represent highly liquid bank timed deposits.

Our DSO at the end of the quarter was 65 days, consistent with the prior quarter. Inventory turns were 1.9, a small increase from the prior quarter.

Turning to our 2012 sales guidance, at current exchange rates, for surgical heart valve therapy we continue to expect sales to be between $800 million and $830 million, which includes approximately $115 million of cardiac surgery system sales. In transcatheter heart valves, we now expect sales of $530 million to $600 million. Lastly, in critical care, we now expect sales at the bottom of the $580 million to $610 million range, which includes approximately $50 million of vascular sales.

We now expect full year total sales at the low end of our original range of $1.95 billion to $2.05 billion. Excluding special items, we now expect full year 2012 net income growth of approximately 30% and diluted EPS of $2.58 to $2.68.

For the second quarter 2012, we project total sales of $470 million to $500 million, and second quarter diluted EPS, excluding special items, to be between $0.64 and $0.68.

And with that, I’ll turn it back over to Mike.

Michael Mussallem

Thanks Tom. As we continue to expand our U.S. introduction and make progress toward the completion of several notable upcoming milestones, we remain as optimistic as ever about the long term growth opportunity represented by transcatheter valves. Nearly every day we are reminded just how impactful our SAPIEN technology is to patients suffering from severe aortic stenosis.

More broadly, we believe it is our focus on innovation to address unmet patient needs that continues to create value for all of our stakeholders.

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

David 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 as we can during the remainder of the hour.

Operator, we’re ready for questions please.

Question-and-Answer Session

Operator

Thank you. [Operator instructions.] Our first question comes from the line of Bruce Nudell from Crédit Suisse. Please proceed with your question.

Bruce Nudell - Crédit Suisse

Mike, could you just talk qualitatively about the level of enthusiasm - you know, hospitals have to invest $3-5 million to build a hybrid cath lab. Could you just talk about qualitatively your level of interest in making that sort of investment? And I have a follow up.

Michael Mussallem

Well, the level of enthusiasm continues to be very high from hospitals. I think it would be an exaggeration to say that every hospital that starts a transcatheter program needs to build a hybrid OR. They don’t necessarily have to do that. They could upgrade a cath lab if they can get sufficient air turns and so forth. So there’s other ways of getting there more economically. Many hospitals do step up and go for the hybrid, though, Bruce.

Bruce Nudell - Crédit Suisse

And a follow up, Mike. The one thing that was very striking to me at ACC was the association between perivalvular leak and excess mortality. I think it was like 15% if there was any present. You know, they didn’t prove causality, but how important does your team feel that reducing the rate of perivalvular leak from 50% of the patients with at least some sign of it, how much of an impact could that have on outcomes going forward?

Michael Mussallem

Yeah, that was a very thoughtful question, Bruce. You’re right, the causality has not be demonstrated, but it’s certainly caught the attention of physicians. We know they’re very focused on reducing the leak, because of the possibility that it might be related. So we see more emphasis on that than ever. We see people are really focused on sizing. They’re using CT more often. They’re doing more reballooning. They may even be starting to drift toward larger sizes a little bit more. So it’s just sort of a head nod to the way clinicians are reacting to that effect.

Operator

Our next question comes from the line of Tom Gunderson from Piper Jaffray. Please proceed with your question.

Tom Gunderson - Piper Jaffray

First question is on NCD, Mike, or the NCA, whichever. The tracking statement online still says May 2nd. You said early May. Do you see any reason why it wouldn’t be May 2nd? And also, related to that, has there been any change in the reimbursement amount tracking to the same DRGs that we’ve known for a while?

Michael Mussallem

No, I don’t know any reason to believe that it won’t be May 2nd. We think that that is clearly where they’re headed. And in terms of the amount that it’s tracking to, I’m not aware of any change to the amount. It continues to track to the high-risk surgical aortic valve replacement.

Tom Gunderson - Piper Jaffray

And then, related to that is that you’ve mentioned that some of the new startups have postponed because of confusion on reimbursement, and I’ve talked to some existing hospitals that feel as though they’re holding back on patients. Do you expect, and are you ready for, a bolus of patients that might come through after CMS makes its final decision?

Michael Mussallem

You know, we’re not sure exactly how that’s going to work out, Tom. Even once that NCD is out, it’s going to need to be interpreted by the local providers and I understand that actually instructions come sometime after the NCD is out, a matter of weeks later. And so I don’t know that this will be a step function, but rather something that sorts out over a period of time. Some sites did indeed delay, and others basically came in and filled their plate. So for people that stepped out of line, there’s a pretty good queue of people that stepped in behind them. So most of our slots got filled.

Operator

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

Bob Hopkins - Bank of America

Just a couple on the guidance. First, Tom, on profitability. Did I hear you correctly that the reduction in EPS of roughly $0.12 is primarily related to that $30 million reduction in your TAVI assumptions?

Thomas Abate

Yes, you did, Bob. It’s not entirely, but it’s primarily.

Bob Hopkins - Bank of America

So that gives us a little glimpse into incremental profitability. That would suggest an incremental margin on TAVI of about 65% if my math is correct, unless I’m doing something incorrectly there.

Thomas Abate

Well, there’s a few moving parts there, and that’s where I’d say you probably don’t want to draw too much from that analysis. I think it’s an indication but there are other things in there that could throw you off.

Michael Mussallem

I think it’s worth noting, Bob, for example, there’s expenses that also track along with that. For example, the training expense and so forth, if those don’t come on as soon.

Bob Hopkins - Bank of America

Right, and I’m just trying to get a sense for, as you move forward and grow this business, the incremental profitability that gets layered on as you grow across a more and more fixed cost base. It’s just an impressive look at profitability here is the point. And then the second question is just on what happened in the quarter. Just want to make sure I’ve got the breakdown correctly for U.S. So you did $41 million in sales. I think you said $7 million of that was related to trial revenues, leaving $34 for clinical. And then I think you said about $10 million was related to stocking, and $24 million related to implants. Is that correct?

Michael Mussallem

Yeah.

Thomas Abate

It comes out about that way. I think, what did we say, 30%?

Bob Hopkins - Bank of America

Okay, and so my question is in the new centers, the 60 new centers, can you give us a sense as to the implant trends that you’re seeing as those new centers come on in terms of, you know, what’s the average number of implants you’re seeing on a weekly or monthly basis among those new centers? And then related to that, it looks like you’re lowering the midpoint of the U.S. guidance by about $10 million. And yet I would calculate that the delay in PARTNER A would have reduced U.S. guidance by more like $20 million or $30 million, so is the delta there that just the other stuff is going much better than you thought in terms of implant rates, and that’s why the reduction is really only $10 million?

Michael Mussallem

The first one here, about the averages, that’s not that helpful, because it’s pretty highly variable at this point in time. The experienced centers, those that have well developed networks and referral patterns, they have the ability to do a lot of cases. The new centers - and when we gave this number of centers that were trained, the 60, that meant that they’ve been through our fundamentals training, and so in some cases the centers literally had no implants in the quarter. And so averages don’t become very meaningful. We’re in this time where there’s a pretty great variance between centers.

And as it relates to the impact that you suggested was around $10 million in the U.S. Yes, in fact, the delay of a cohort A panel and a one-quarter delay overall is worth more than $10 million, and it is indeed this ramp that is faster than we had anticipated that’s mitigating some of that impact. And that’s why only around $10 million.

Operator

Our next question comes from the line of Amit Balla from Citigroup. Please proceed with your question.

Amit Balla - Citigroup

I had a question regarding Europe and the TAVI adoption over there, in two parts. First, can you talk about what impact competition is having over there. And can you parse that out against the underlying market dynamics in western and southern Europe?

Michael Mussallem

Sure. The two new competitors, you know, they’re not strategic at this point, and they’ve had some impact, but it hasn’t been very large. They basically really have just been in Germany, and we estimate maybe 125 implants or something like that in the quarter. So maybe that gives you a sense for that. As we indicated in our prepared remarks, we think Europe is going to grow somewhere in this 20-25% range overall as a total market in 2012. We think it probably grew something like that in this quarter. Is there more that I can answer about that?

Amit Balla - Citigroup

Yeah, I guess competition, I was thinking more about larger-sized valves. You have a new valve that will be coming out this summer, but one of your major competitors has one there already. So I was actually focused on that part of the competition question. And Europe, parsing out the regions, was more about southern Europe, like what you’re seeing there. Any pullback there?

Michael Mussallem

Well, let me get into southern Europe, and then maybe a comment about share. Southern Europe probably as an overall region was around flat again this quarter. For us it was actually negative. I think it was probably close to minus 20% sales growth. Again, southern Europe only accounts for probably a little less than 20% of the overall market. So you can see that it did pull down the overall growth of Europe.

In terms of the importance of 29 mm, we feel like we’re the clear share leader, and we think that having a 29 mm in the transfemoral position is going to be very important. Remember, when we got that 29 mm in the transapical position, about a year ago, it really added a lot of sales. And we think it’s going to be powerful.

And since TF is the preferred method of delivery, it might even pull some of that 29 mm TA volume away. So it’s a positive for us. We think it’s going to be a real share gainer, that drives share in the transfemoral position. We’re also excited about having the new Ascendra Plus, because it’s going to open up the transaortic delivery. And although that’s still relatively small, maybe 150 implants a quarter, it’s growing, and we haven’t had an indication thus far. So those have all largely been competitive units until now.

Operator

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

Raj Denhoy - Jefferies & Co.

Wondering if I could just ask you to expand a little bit on your commentary on the distribution of volume at the various types of centers. When you look at the highest-volume centers, whether it’s Columbia University or Cedars Sinai, the big PARTNER trials, do you have a sense of what percentage of valves are being done at these highest-volume centers right now?

Michael Mussallem

I don’t know. We don’t normally cut it that way. Let’s put it this way. You think about the volume that was done in the United States. We said about $7 million of that was clinical, so I’ll set the $7 million aside. We said out of the $34 million, a good 30% of that was stocking. So none of those stocking orders came from the large sites. So now if you further parse that down to a smaller part, out of the remaining, I would imagine the large centers made a substantial impact. I don’t know if it was half of that, but it was significant. They’re experienced, and they have well developed referral networks.

Raj Denhoy - Jefferies & Co.

Okay. You know, you described the SAPIEN III, you gave us a little teaser there on some new technology that might address perivalvular leakage. Is there anything more you can comment on on what that is at this point?

Michael Mussallem

Yeah, you know, we haven’t laid out the design exactly. I’m sure you’ll get a chance to learn a little bit more about it at PCR. Obviously one of the most exciting features has been designed, and it’s a very innovative design, such that it can go through a 14-French eSheath. But in particular, it has a design feature that’s really pointed at reducing and having a substantial impact on perivalvular leak. For competitive reasons we haven’t put it out there, but at some point here it will become clear to everybody. It won’t be a secret. We’re going to be in clinical trials by the end of the year hopefully.

Operator

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

Glenn Novarro - RBC Capital Markets

First, on reimbursement, when the NCD comes out in a week or so. We’ve been hearing that some of the more challenging language that was in the original proposal may be less so in the final proposal, such as requiring clinical trials to have a superiority end point for reimbursement, and making sure that [interventionalists] have structural heart experience. Is it your understanding that in the final language it will be slightly more favorable than the proposal? Any of your thoughts. And I had a follow up.

Michael Mussallem

We don’t know, Glenn, obviously. We just don’t have an inside track on exactly what that’s going to say. I think we’re pretty clearly on the record of agreeing with the two comments that you just made. We don’t think it should be restricted to superiority trials, and we think there should be some real care in credentialing. We think it’s more important to credential the team rather than some of the specific physician based credentialing that can be too restrictive in terms of access to patients. But we’re not going to know exactly how that works out. We’re hopeful. The good news here is there’s been a collaborative style by CMS, and we’re very pleased that they’ve taken input. But we’re, like you, anxious to see what the final language says.

Glenn Novarro - RBC Capital Markets

And just a quick follow up. When you look outside the U.S. to Europe, you mentioned France, the country not allowing more hospitals to implant. Does that really impact the sales much? Do patients find their way to the implanting centers? And then are there any new geographies or countries that you’ll be launching outside the U.S. this year?

Michael Mussallem

Yeah, in France, in particular what we were referring to, there was a rule - and I’m probably not using the right term here - but there was a rule out that suggested there was going to be an addition of more centers in 2012, and that got postponed. So we’re expecting there are going to be approximately 10 more centers that we expect to come online later this year. And we do indeed think it will make a difference. We think there’s a lack of coverage in France without these centers. And that was a determination that was made at their government level.

In terms of the positives, the U.K., you know, stepping forward. This decision that they made to pay for nonoperable patients is a real positive. And we’re already seeing that effect, even though it’s not even in effect yet. We saw a positive indication recently out of Scotland, which was great. On the downside, we still don’t have a positive indication out of Belgium, so we’re awaiting that. And we’re continuing to make slow but steady progress across Asia as we’re working through various approval processes. But nothing as meaningful as Japan to talk about at this point in time.

Operator

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

Larry Biegelsen - Wells Fargo

Mike, just two clarification questions and then one O-U.S. question. The 60 new centers, is that by the end of Q1, or is that to date? In the U.S.

Michael Mussallem

That was at the end of Q1 from the approval date.

Larry Biegelsen - Wells Fargo

Got it. And you said transapical was stable sequentially in Europe, if I heard you correctly?

Michael Mussallem

That’s correct.

Larry Biegelsen - Wells Fargo

My question, then, is O-U.S. growth, the new guidance assumes it’s about 10-20%. I think it’s 9-18% growth in 2012, which is a big deceleration from last year. There’s new competition coming next year in 2013 in Europe. Can you walk us through why you think international growth can continue to be positive and strong beyond 2012?

Michael Mussallem

I’m not sure exactly. I think you must have backed into a number, because I think what you referred to was something that I didn’t share. But what we feel like is in Europe, even with the slowdown in southern Europe, we expect it to grow in the 20-25% range this year. We think it might have grown probably 25%-plus that this year, otherwise. And last year it grew 35%.

And so considering the size of that European market, that’s still pretty significant, and if you look at penetration rates across Europe, they’re still, I would say, low and highly variable. So for example there’s a big difference between the penetration rate in many of the countries in Europe and the more penetrated countries like Germany.

So there’s still an awful lot of potential and we really are only in western Europe at this point. So the [ascension] countries are yet to be penetrated at all to speak of, let alone what might happen in Asia. So we’re still very bullish about what’s going to happen beyond this.

Operator

Our next question comes from the line of David Roman from Goldman Sachs. Please proceed with your question.

David Roman - Goldman Sachs

Mike, I was hoping you could actually go into a little more detail on the surgical valve business. One of your competitors has been pretty vocal about the success of their product launch in the United States. Can you just talk about your level of confidence in that abating in the second half of the year? Is that just the comps? Or is there something specific that you think fundamentally can drive business back in your direction?

Michael Mussallem

We have a little bit of experience with competitive new product launches, and in particular where we see the most acute effect is during the first year of launch. One of the things that happens during the first year of launch often is clinical trialing, and it’s not uncommon for surgeons to be willing to try a new valve. That doesn’t always stick. In some case it does, and in other cases they all retreat back to their favorite valve.

And so we expect this really to mitigate in the second half of the year, based on that impact. And also, we have a little bit of experience in Europe. That exact same valve was launched earlier in Europe and at this point that’s already anniversaried, and we grew in mid-single digits in Europe, which is probably a little faster than the market grew. And so some indication why we have some confidence.

And besides that, the whole market we’re expecting might step up a little bit with transcatheter heart valves coming into the U.S. market. We would think it might give the market a bit of a lift as well.

David Roman - Goldman Sachs

And maybe just following onto that, and also coming back to the delta on the transcatheter valve guides. And could you maybe provide a little bit more detail on the assumptions that you’ve considered in the revised guidance given, clearly, the amount of nervousness coming into the quarter and some of the variances on Street models and expectations around the transcatheter valve? If you could just give us some perspective as to what kind of acceleration you’re assuming, and are you taking into account a step-up in the surgical valve market here? Just to give some greater confidence bars around these numbers.

Michael Mussallem

Yeah, I think the change in sales guidance really is primarily all around transcatheter heart valves. And I think we shared that there were three components of that. One is the foreign currency. As Tom indicated, that really didn’t have much impact on the first quarter, but we expect that it’s going to have something in the neighborhood of $10 million worth of impact in transcatheter heart valves alone for the remainder of the year.

The other impact we talked about was just dynamics in Europe, and compared to our original assumptions, we think that that might be as much as something in the neighborhood of $10 million less. And then we feel like in the U.S., even though there’s what’s anticipated to be, say, a quarter delay in the approval of cohort A of the PARTNER trial. We think that does get mitigated by the strong first quarter and this ramp that we felt, that was not just driven by stocking orders, but it’s driven by real procedures and reordering. And just take a look at the $40 million number and ramp that by itself, and you can probably see why we have a level of confidence.

David Roman - Goldman Sachs

Okay, so essentially you’re looking at the utilization rates exiting the quarter and assuming that that continues to accelerate up as it did throughout Q1 in the balance of the year?

Michael Mussallem

Yes, we think it’s a ramp.

Operator

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

Kristen Stewart - Deutsche Bank

I guess back at the investor day you guys had talked a little bit about the cadence of sales for the U.S. with more of a flattish sequential pattern, just because of consignment. I was wondering, with the pushout of timing for cohort A, are you still expecting to see that sort of cadence, or have you changed your thinking upon doing consignment at all?

Michael Mussallem

Nothing has changed in terms of our strategy. It’s a little hard to predict, because our procedures are a little higher. Remember the effect that we predicted. We said early on we would get a boost from stocking orders. So we would actually have sales higher than procedures, and then later on, when people demonstrated large volume, we would move to consignment, and that consignment effect would actually depress reported sales in the procedure driven sales, because they would go to consignment. That effect is still in place. Exactly how those two net against each other, we have models on, but we really can’t be sure. And to know exactly what’s happening on a month by month basis is pretty murky at this point. But broadly, we still stand by the same phenomenon.

Kristen Stewart - Deutsche Bank

And just to clarify, the greater sales in the quarter you said were more procedure driven, versus stocking or clinical trial?

Michael Mussallem

That’s right. We try to give enough definition so that you can sort that out, but we would say it’s 70% procedure. Set aside the clinical trial of $7 million that we talked about in the U.S. Out of the remainder, 70% was procedure, 30% stocking. And we would say compared to the guidance that we provided to you, we felt like procedures came in stronger.

Kristen Stewart - Deutsche Bank

Okay, and then just big picture, it seems that certainly transcatheter valve sales, at least now, are certainly ramping up better than what you’re expecting. They’re clearly very profitable, as evidenced by just the changing guidance, and then the reduction in EPS. So with this anticipated large influx of cash flow to come, what are you thinking just in terms of usage in terms of M&A? We’ve typically seen a lot of companies look to diversify their sales base and just wondering if that’s something that you’ve given a lot of thought to going forward? Just how do you think about that?

Michael Mussallem

Yeah, we do give thought to it. There’s really no change in our strategy. We’re very consistent. We’re going to stay focused. We don’t believe that we need to diversify. We feel like there’s plenty of growth and unmet needs around structural heart disease and critical care monitoring, and so we’ll continue to look for the right opportunities. Tom talked about the fact that we did a purchase program with stock. We’ll continue to do that when we think conditions warrant it.

Operator

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

Michael Weinstein - JP Morgan

I probably just want to circle back on a couple of items. Maybe first question, the request to expand on the Anderson patents, have you filed that subsequent to product approval?

Michael Mussallem

We did file it. As a matter of fact, we did receive the one-year extension. So this was what we anticipated. It’s kind of an interim. You get this one year at a time. But the one year actually has happened.

Michael Weinstein - JP Morgan

Great. Let me make sure I understand the guidance commentary, because obviously if we just looked at EPS, you came in at $0.05 above this quarter, the consensus, and you’re guiding to a number in the second quarter that’s about at the midpoint, $0.07 above consensus. But you’re saying the back half of the year is in essence relative to your own prior guidance - and this is a little bit of apples and oranges - $0.24 below. So you’re lowering your full year by $0.12.

But the degree to which consensus had the first half right, you’re telling the Street to take that much out of the back half of the year. And I just want to make sure I understand that. I thought Bob kind of got to one of our questions, which was that the incremental profitability of TAVI for you guys, which is helpful. But maybe just help us understand that a bit, Tom. You’re taking a big chunk of earnings out of this back half of ’12.

Thomas Abate

Sure, and Mike, it’s consistent with the idea that we got the one quarter delay. Also, some of the things in Europe, some of the dynamics that Mike talked about there, are probably more affecting what we had expected in the second half versus what we thought in the first half. So a little bit of delay there also.

The other thing - and I tried to mention that with Bob - is to take that number, the math is not only THV. We move within ranges often, and so when we make a change on the bottom, there’s a little bit of change maybe in a couple of other things. So I would not take that math totally literally. It’s fair to make it an indication of the profitability, but I wouldn’t go too far with that.

But indeed, as you’re suggesting, most of our change happened in the back half versus our expectations.

Michael Weinstein - JP Morgan

Okay, and then last question is related to the national coverage decision and the expansion on cohort A. So assuming you get the labeling for cohort A, will there be any restrictions either from the FDA or CMS on the use of the transapical in cohort B patients?

Michael Mussallem

What we’re going to have to see is exactly what the label looks like coming from FDA, and what the CMS language looks like. One of the things that was, we thought, quite encouraging in the draft NCD was the use of coverage with evidence development, which suggests a flexible NCD that would have the ability to move with the FDA indication. And we’re hopeful that that’s the case, such that the transapical procedures would be reimbursed consistent with the label.

Operator

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

Jason Mills - Canaccord

Let me go back to profitability real quick. I’m wondering if you could give us a sense, quantitatively, where you are at this point in the U.S. as it relates to the sales and marketing training, reimbursement infrastructure, the things that would hit the SG&A line in the U.S. for TAVR. Where are you in terms of building that out at this point? Clearly you will add reps, etc., as your revenue builds, but I’m just curious, as you think about the initial investments there outside of regulatory where you are. To try to get a difference in for profitability.

Thomas Abate

In fact, we do have a substantial portion that’s already in it. But I think you nailed it in the fact that we will increase expenses. I think the best thing to look at, probably because most of this will occur in SG&A, is think about the guidance in terms of the range for SG&A. We know we’re going to see leverage there despite the fact that they’re increasing. But I don’t know how to give you a specific number in terms of another reference point. But I think that would probably be the best way to look at it.

Jason Mills - Canaccord

So did I hear you right, Tom, that the upper end of your TAVI range would correspond more closely with the lower end of your total SG&A guidance?

Thomas Abate

Right. Correct.

Jason Mills - Canaccord

Okay. That’s helpful. And sorry if I missed it, the transapical transfemoral mix outside the U.S., did you give that, Mike?

Michael Mussallem

No, we didn’t give that. We gave sort of an overall.

Jason Mills - Canaccord

70-30 overall.

Michael Mussallem

Yeah, exactly. And I don’t have it off the top of my head, but you could probably back into it. The clinical trial has both transapical and transfemoral, though mostly TF, and the U.S. commercial sales is all TF.

Operator

Our next question comes from the line of Spencer Nam from ThinkEquity. Please proceed with your question.

Spencer Nam - ThinkEquity

Mike, did you mention that you had trained 60 centers at this point?

Michael Mussallem

Yes.

Spencer Nam - ThinkEquity

And so to get to your 150-250 range, should we expect somewhat of a linear growth on the number of centers being trained each quarter? Or do you expect more of a back-loaded ramp up here?

Michael Mussallem

Yeah, there is a bit of a ramp. So again, let me just remind you what we indicated. We said, since launch - and remember this is since the first week in November - we’ve trained 60 centers as of the end of the first quarter. So you can see that captures a little [unintelligible], but there clearly has been a ramp. And we’ve come up.

And so we’ve got a lot of hospitals that are in the queue and there tends to be a little bit of churn early on as some people were prepared and others weren’t prepared. That’s lining out. We certainly have more than enough capacity. We have the ability to ramp that. And some of this will be driven by whatever the NCD says as well. So we’ll see how it goes. Based on everything we know, we think the 150-250 tends to be real solid.

Remember there’s one other thing, that once we get cohort A approved, we’re going to ask centers that weren’t part of the PARTNER trial and already don’t have TA experience to come back through training. It might be a one day training that they come back through. So some training capacity will go into that at that point in time.

Spencer Nam - ThinkEquity

That’s helpful. And then in terms of lead time, once a hospital gets trained, what kind of lead time do they have before they can start implanting on a regular basis, if you will? I know the term regular basis is a little bit of a moving target, but is that a four-week lead time? Three-week lead time? How should we think about that?

Michael Mussallem

When hospitals come in for training, they bring patients, and typically that’s five patients that they bring in such that these are real patients that are ready to go. They can schedule the proctor right away. And sometimes can actually start cases as soon as a week after their training. So it just depends on how aggressive they are and how fast they’re ready to move.

Operator

Our next question comes from the line of David Lewis from Morgan Stanley Smith Barney. Please proceed with your question.

David Lewis - Morgan Stanley Smith Barney

Mike, in the U.S., can you speak to the mix of delivery approaches for SAPIEN, non-transfemoral approaches? I’m just wondering, can you give a sense of what that mix is? Has reimbursement been a problem for those procedures for some of the tertiary centers? And can that issue be addressed specifically with the NCD?

Michael Mussallem

You know, the only thing that is approved at this point, you’re aware, is transfemoral for nonoperable patients. And so anybody that does something other than that is really doing some kind of a compassionate case. At this point, I think everybody’s clearly focused on nonoperable patients, and I’m sure there have been some cases that have been done that are not transfemoral, but I don’t know exactly what those numbers are at this point.

David Lewis - Morgan Stanley Smith Barney

Would it surprise you if that number were greater than 10% of the U.S. cases?

Michael Mussallem

I really don’t know. It’s a good question.

David Lewis - Morgan Stanley Smith Barney

Okay. But the reality is because of the label, that issue probably does not go away with the NCD.

Michael Mussallem

No, that’s right. But I think the NCD tries to accommodate that through coverage with evidence development. But we’ll see exactly what the new language looks like. But what is anticipated is if we were collecting data - and again, we’re supportive of this idea of collecting all patients in a registry - and if we do it in a proper fashion, that there’s a good chance for people to be paid.

Okay, thank you very much for your continued interest in Edwards. Tom and David and I welcome any additional questions by telephone. And with that, back to you David.

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 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 account number 2995 and passcode 392053. Additionally, an audio replay will be archived on the investor relations section of our website.

Thank you very much.

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