Greetings and welcome to the Edwards Lifesciences Corporation Fourth Quarter 2011 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, David Erickson, Vice President of Investor Relations. Thank you. Mr. Erickson, you may begin. David Erickson;Vice President of Investor Relations: Welcome, and thank for joining us today. Just after the close of regular trading, we released our fourth quarter 2011 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 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, as well as the timing, status and expected outcomes of new or currently ongoing clinical trials, the expected impact, ramp-up and benefits of new product introductions 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, 2010, 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. Also note that we calculate operating leverage as gross profit minus SG&A and R&D expenses divided by net sales. Now I'll turn the call over to Mike Mussallem. Mike?

Thank you, David. Our fourth quarter closed out a year of significant investment and major milestones for Edwards. Successful PARTNER trial results led to regulatory approval to begin offering our transcatheter heart valve technology to many inoperable patients in the U.S. And for 2011, excluding special items, we were able to achieve 10% net income growth, while increasing R&D by 20% and making considerable investments in our U.S. launch. Now turning to quarterly results. Reported sales grew 10% to $430 million, which was consistent with the guidance provided at our investor conference. On an underlying basis, sales grew 8%. Sales outside the U.S. grew 11% on a reported basis and represent nearly 2/3 of our total sales. For heart valve therapy, reported sales for the fourth quarter grew 13% to $257 million, which included $93 million from transcatheter heart valves. Surgical heart valves grew 2% over last year on a reported basis and were unchanged on an underlying basis. Outside the U.S., our surgical heart valve business reported 7% growth, driven primarily by strong sales in Asia and continued penetration of premium products. Pricing remains stable in each geography. However, strong growth in emerging markets changed the country mix, which slightly lowered our global average price. In the U.S., sales declined this quarter due to the introduction of a competitor's product in 2011, along with what we believe were flat to procedural volumes. We expect the impact of competition in the U.S. to diminish in the second half of 2012, with the annualization of that product's introduction. We continue to make progress on our EDWARDS INTUITY rapid deployment aortic valve system. We've submitted responses to the additional questions we received in late 2011 and now expect CE mark approval during the first quarter. We will then initiate 2 European post-approval clinical studies, Cadence and Foundation. Additionally, we remain excited about our next-generation tissue technology, GLX, for which we anticipate receiving a CE mark in the second half of 2012. Turning to Cardiac Surgery Systems. Sales for the quarter were $27 million, up 8% on a reported basis and 7% on an underlying basis. These results were primarily due to growth of MIS products, which are recovering from the product availability issues earlier in 2011. Late in the fourth quarter, we received both a CE mark and a 510(k) clearance for our IntraClude aortic occlusion device designed to reduce the learning curve for MIS mitral valve surgery. We continue to expect a limited launch in the first quarter as we collect additional clinical evidence. IntraClude is the first of several new products we expect to introduce into our MIS portfolio in 2012. As a reminder, beginning this year, we will be reporting sales of surgical heart valves and Cardiac Surgery System products together in a product line called Surgical Heart Valve Therapy. In 2012, we expect to achieve underlying sales growth of 3% to 5% in this product line, driven by expected improvement in valve procedural volumes and continued momentum of our newest products. Turning to transcatheter heart valves. Fourth quarter sales were $93 million or 43% growth rate over last year. Although the U.S. launch was later than we anticipated, it was a significant growth driver. Economic pressures in Southern Europe resulted in lower procedural volumes, which affected our growth rate. Transapical sales were comparable to levels reported in previous quarters, although the impact of 2 recently approved products in Europe trimmed sales approximately $1 million this quarter. Transfemoral units accounted for approximately 60% of our sales, lifted by the U.S. launch, which today is entirely transfemoral. Product pricing remains stable outside the U.S., and inside the U.S. is consistent with our expectations. As you know, in early November, we received FDA approval of our SAPIEN valve in the United States for certain inoperable patients. Total U.S. sales in the quarter was just over $17 million, with about half from commercial sales and half from clinicals. Approximately 3/4 of our commercial sales were stocking units from new centers that completed their training, and we continue to expect to train 150 to 250 new commercial sites in the first 12 months. As we have previously stated, achieving and maintaining a high level of acute procedural success just as we have in Europe is our first priority and will drive the pace of the SAPIEN rollout. While we've just begun, we're very pleased with our high success rate. Last fall, CMS initiated a national coverage analysis for TAVR, which is expected to result in a national coverage determination or NCD. This early NCD process has resulted in inconsistent interpretations among the regional Medicare contractors. The majority of these Medicare payers are reimbursing on a case-by-case basis, while policies of others are still evolving. This uncertainty has led to somewhat lower than expected sales. Edwards along with physicians, hospitals and medical societies are working to ensure the patients throughout the U.S. have adequate access. We believe this reimbursement situation will improve as payers clarify their policies. In the last hour, CMS has posted on their website a proposed decision memo for TAVR. This 88-page document appears to be very comprehensive. And while we welcome the accelerated timeline, we have not yet had adequate time to assess it. As a reminder, it should trigger a 30-day public comment period and suggests that a formal NCD could issue in the next 90 days. We support a well-written NCD that ensures adequate patient access. Even with this temporary uncertainty in the first quarter, we expect to achieve commercial and clinical SAPIEN sales up $30 million to $40 million in the U.S. Earlier this week, at the STS meeting, data from the continued ACCESS patients in Cohort A of The PARTNER Trial were presented by Dr. Todd Dewey. In this much larger group of patients, the data showed an improved transapical experience. Investigators observe the trend toward patients feeling better faster and having improved outcomes. We believe this more recent experience adds strong new support to the transapical procedure as an important option for patients, who are at high risk for surgery. We expect additional data to be presented at medical meetings during the year, including 2-year data from Cohort A at the ACC meeting in March. We continue to plan for a midyear 2012 PMA approval for Cohort A of PARTNER, preceded by an FDA advisory panel. We remain confident that the trial results clearly demonstrate the benefits of both TA and TF as less invasive treatment options for high-risk surgical patients. We are preparing extensively for this panel meeting and are providing to FDA additional data and analysis of our clinical experience to support our case. Turning to our PARTNER II clinical study. In January, we completed enrollment in Cohort B, studying inoperable patients using our SAPIEN XT technology. Patients will be followed for one year, and we continue to plan for U.S. approval in 2014. For Cohort A, the surgical arm, we remain on track to complete enrollment in 2013. As a reminder, Cohort A is an noninferiority study of up to 2,000 patients with a lower risk profile than those who were involved -- those that were enrolled in The PARTNER Trial. Patients are being evenly randomized to receive the Edwards SAPIEN XT valve or surgery. Those undergoing transcatheter valve replacement are being treated either transfemorally or transapically. As we unveiled in December at our investor conference, we have 2 new low profile transcatheter valve platforms we're very excited about, which we believe will enable us to further extend our leadership position. SAPIEN 3 is our next-generation balloon expandable valve that builds on all our knowledge and experience and includes a unique feature designed to reduce -- further reduce paravalvular leak. We are pleased to have recently completed successful first-in-man cases. CENTERA is our repositionable, self-expanding valve, featuring a motorized delivery system designed for safe, stable deployment and single-operator use. European clinical trials for both these new products, which are delivered through a 14-French eSheath, are expected to commence in 2012. We plan to initiate the PROTAVI trial at the end of this quarter that will study the causes of stroke, as well as our Umbrella device. The results of this study should become available in 2012 and could support a 510(k) for Umbrella in the U.S. With respect to the appeal regarding the Andersen patent dispute with CoreValve in the U.S., we expect the decision by the court in mid-2012. In December, we filed a request to extend the Andersen U.S. patent out to 2017, and we expect our request to be granted. In summary, we continue to expect 2012 underlying transcatheter heart valve sales to grow 70% to 90% over last year. This would result in sales of $560 million to $630 million, which includes $200 million to $260 million of clinical and commercial sales in the U.S. Our sales guidance assumes PARTNER Cohort A is approved and starts contributing to U.S. sales in midyear 2012. Turning to Critical Care. Sales were $133 million for the quarter, up 4.5% on a reported basis, which includes the 2.4% benefit from foreign exchange. Without approximately $5 million of discontinued products, the bulk of which annualizes after the first quarter of 2012, growth would've been lifted by 4.5 percentage points. Driving the growth this quarter were strong sales of our advanced monitoring products, including our EV1000 monitoring hardware and FloTrac. Pressure monitoring sales contributed to global Critical Care growth as we continued to gain share. We are currently gaining clinical experience in Europe on our latest in-hospital glucose system and plan to evaluate additional enhancements in midyear. We continue to anticipate obtaining a CE Mark for this improved system before the end of 2012. Total reported vascular sales, which is comprised of our Fogarty products, were $13 million this quarter, down slightly from the prior year. As a reminder, next quarter, we'll be reporting sales of Critical Care and vascular in the Critical Care product line. For 2012, we continue to expect full year underlying sales growth in this product line to be 5% to 8%, driven primarily by continued growth in our advanced monitoring products. And now I'll turn the call over to Tom. Thomas Abate;Chief Financial Officer, Principal Accounting Officer and Corporate Vice President: Thank you, Mike. This quarter, we achieved diluted EPS of $0.53 and non-GAAP diluted EPS of $0.62, an increase of 13% over the prior year. As we anticipated, our operating leverage improved sequentially to 20%, driven by a reduced FX impact and the U.S. THV sales. Including the benefit of a much lower tax rate, this quarter's non-GAAP EPS exceeded expectations. Excluding this benefit, we would've achieved the low end of our EPS guidance. For the quarter, excluding special items, net income grew 12%. For the quarter, our gross profit margin was 72.2% 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 be between 73% and 75%, building throughout the year as THV sales grow. Fourth quarter SG&A expenses were $163 million or 38% of sales, an increase of $21 million over the prior 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 full year 2012. Driven by the launch-related expenses, the first 2 quarters will be approximately 40%, followed by significant step down in the third quarter and then again in the fourth quarter, due to the expected sales ramp. R&D investments in the quarter grew 9% to $61 million or 14% of sales. This increase was primarily the result of additional investments in clinical studies and new product development efforts in our transcatheter valve programs. For the full year 2012, we continue to expect R&D as a percentage of sales to be between 14% and 15%. During the quarter, we recorded a pretax $17.6 million special charge comprised of 3 items: an $8.8 million charge to reflect the increased collections risk associated with our Southern European receivables; a global realignment charge of $5.5 million, primarily related to severance costs; and a $3.3 million charge related to a legal settlement. Additionally, during the quarter, we recorded a $4 million favorable tax adjustment related to the release of reserves. Our reported tax rate for the fourth quarter was 8%. Excluding the tax effect of special items I just mentioned, the tax rate was 15%, which benefited from favorable year-to-date adjustments in both the income mix and the R&D tax credit. For full year 2012, we estimate our rate, excluding special items, to be between 25% and 26% versus 21% in 2011 full year. This rate increase results primarily from the growth of our U.S. sourced income, which includes the expected THV sales and approved FX hedge outcomes. Our 2012 quarterly rates assume the federal R&D tax rate renewal will not occur until the fourth quarter. FX rates positively impacted fourth quarter sales by approximately $6 million compared to the prior year. Compared to our recent guidance, FX did not have a material impact on the quarter's earnings. Looking forward, at current rates, we now expect a $40 million negative impact to 2012 full year sales when compared to 2011 rate. Free cash flow generated during the fourth quarter was $62 million. We define this as cash flow from operating activities of $94 million less capital spending of $32 million. This resulted in the full year free cash flow of $183 million, which was lower than planned due to higher-than-expected inventories. During the quarter, we repurchased 560,000 shares for $40 million. For the full year, we repurchased 3.9 million shares for $303 million. For modeling purposes, we project diluted shares outstanding to be 119 million in 2012. Turning to our balance sheet. We had total cash and cash equivalents and short-term investments of $450 million, and total debt of $150 million. The short-term investments of $279 million represents bank time deposits with initial maturities ranging from greater than 3 months to 7 months. These time deposits are highly liquid and were included in error as a part of our cash and cash equivalent in our 2011 interim statement. We are now reclassifying these items, these time deposits, as short-term investments, and will reflect the purchases and sales as investing activities in our statement of cash flows for the full year 2011. This change has no effect on any other aspect of our financial statement or guidance. We are currently evaluating the manner in which we correct these previously reported amounts. Our DSO at the end of the quarter was 65 days, an improvement of 5 days from the prior quarter, driven primarily from collections efforts outside the U.S. Inventory turns were 1.8, a small decrease from the prior quarter. Turning to our sales guidance. We continue to expect our full year product line sales range to remain unchanged from the guidance we provided at our December investor conference. For surgical heart valve therapy, we expect sales to be between $800 million and $830 million, which includes approximately $150 million -- $115 million of Cardiac Surgery Systems sales. In transcatheter heart valves, we expect sales to be between $560 million and $630 million. In Critical Care, we expect sales of $580 million to $610 million, which includes approximately $50 million of vascular sales. We continue to expect full year sales of $1.95 billion to $2.05 billion. Excluding special items, we remain comfortable with our previously stated financial goals of full year 2012 diluted EPS of $2.70 to $2.80, 73% to 75% gross profit margin, net income growth of 35% to 40% and free cash flow between $240 million and $260 million. These goals assume a midyear 2012 approval of Cohort A of The PARTNER Trial. For the first quarter 2012, we project total sales of $440 million to $460 million, and first quarter diluted EPS, excluding special items, will be between $0.47 and $0.49. With that, I'll turn it back over to Mike.

Thanks, Tom. As we look ahead, we see an exciting future for Edwards Lifesciences. We believe that our transcatheter valve technology has the potential to drive significant sales growth over the next decade. Our focused strategy on structural heart disease and Critical Care Technologies creates multiple points of leverage, and our commitment to innovation should enable us to extend our leadership and create value for patients, clinicians and our shareholders. Before I turn the call back over to David, although I'm certain that you have many questions about the recently published draft NCD, we're unprepared to provide analysis at this time. This extensive document requires careful review and consideration. Therefore, we're not going to be answering questions about this at this time. And with that, I'll turn the call back over to David. David Erickson;Vice President of Investor Relations: Thank you, Mike. [Operator Instructions] Operator, we're ready to take questions, please.

[Operator Instructions] Our first question comes from the line of David Lewis from Morgan Stanley.

It's Steve Beuchaw here for David. Mike or Larry, I wonder if you could go into a bit more detail articulating the dynamics with SAPIEN in Europe. If we said, just for the sake of discussion, that the result in Europe came in $30 million below where it would've been in a hypothetical, where the growth rate in the fourth quarter were the same as it was in the third quarter, understanding, of course, that wasn't necessarily in the plan, and how much of that $30 million was competition? How much was macro? How much was pricing, if that's an issue at all? And how much might've been a shift towards transfemoral?

I think there's some confusion. I don't know where your $30 million comes from, but I'm happy to walk through some of these pieces. As I indicated on the call, the new competition, as it relates to TA, was worth about $1 million. And we don't feel like we lost share to our other competitor in Europe. So that's really not a factor. You know where I think sometimes people get confused is when they go back and look at our results and compare it to what we've done. So for example, we said there were $334 million worth of sales for the full year of 2011 in transcatheter heart valves. Some of that was U.S. clinical -- around $20 million that you have to back out. Some of that came from other parts of the world that accounted for almost 10% of those sales. So that when you -- when you actually -- and there's another whatever it was, the $9 million or so of commercial U.S. sales, so you need to back those pieces out when you actually compare growth rate in the quarter.

One follow-up on Europe. Could you comment on your expectations for the duration of the macro challenges there? Could you elaborate a bit also on how they're manifesting there? Is it pricing? Sounds like that's not the case? Does it manifest as just a receivables issue or is there something else?

Are you talking about transcatheter heart valves in the quarter? Or...

In Europe, specifically?

All right. I'm going to assume that's what you're talking about. We mentioned that we were affected in Southern Europe. And so in particular, we saw growth rates decline in places like Greece and Italy and Spain, all of which were good markets for transcatheter heart valves. And so that was the driving force. Pricing has been rock stable. And our hope here is that this picks back up, that this is a temporary situation driven by some difficult economics in those countries.

It sounds like, then, it's a temporary situation in its volumes, is that fair?

That's what we'd like to think. I mean, I'd like to think that those countries don't stay in the same sort of straits that they're in, in the fourth.

Our next question comes from the line of Raj Denhoy from Jefferies & Company.

I wonder if I could ask about the -- you're not going to answer the NCD, but you did mention that there's a little bit of reimbursement push back right now. And our understanding is part of that was perhaps related to the fact that there wasn't a national policy. Does the publication of NCD regardless of your views of what's in it, does that have any bearing on the reimbursement situation out there right now?

Yes, I'll share what our thinking is on that, Raj. It's a good question. Before an NCD was open, it seemed as though we had a fair amount of clarity, and there was pretty clear coverage by these local providers throughout the clinical trial period. And we would've imagined that, that would continue in a very stable way going forward. When the NCD was actually open, and it's relatively unprecedented that an NCD or a national coverage analysis is open even before approval, it created some of this confusion and it caused some of these providers to say, "Gee, I don't know what this means. Maybe I should wait," and a whole variety of interpretations of what that meant. We'd like to think when we actually land on a decision, and we're hopeful that the decisions are good ones, that it clarifies the temporary situation.

Okay. And just on the expectations here for a panel soon in approval for PARTNER A by midyear. You also commented about how you're continuing to supply the FDA with information, whether it's continued ACCESS data we saw earlier this week. You also mentioned the data coming out at ACC here. So there still is data being presented to the FDA, and I'm curious whether that could potentially have some impact on their ability to schedule a panel?

I don't know, frankly, what impacts their scheduling of the panel, Raj. We don't have a date at this point. We believe it's in the best interest of the technology and help FDA with their decision making to have as much up-to-date experience, clinical experience as possible. And so we're providing that. And when the day goes out longer, it just allows us to probably even provide more. But I don't know. I really have no insight into whether that's driving any decisions on timing.

Our next question comes from the line of Jason Mills from Canaccord.

I wanted to ask about your training program, Mike, for TAVI in the early days of commercialization. It's gratifying to hear that you're reiterating your guidance of $150 million to $250 million. You had a principal investigator at STS comment on the podium about his thoughts, maybe getting to $200 million by the end of 2013. I suppose I could have heard him wrong. But your commentary seems to suggest you're confident in getting to $200 million perhaps in the first year, which would be sort of exiting this year. Could you talk about over maybe the next 18 months what your thoughts are with respect to the ramp in new training centers? And any color you could provide around how it's going early with some of the centers you've gotten on board in the first 3 or 4 months?

Okay. And I'm not going to get into a specific count of how many people have gone through. But we've said right along here that we have expected to train 150 to 250 new centers in the first year, and we haven't backed off that at all. We've built capability, and we have the internal capability to certainly train that number of centers and more. So it really doesn't have anything to do with our internal capability. So I think what it's probably going to -- what would be more of a factor is whatever comes out in the national coverage determination, whether there's any limits. If there are limits, that could change the number, but otherwise, I would expect that we would stay right on that plan, and we would hit $150 million to $250 million in the first year and escalate from that into the second year.

Yes, our initial read looks like it was a fairly flexible document and inclusive. So we look forward to hearing your analysis. I suppose on that front, should we expect to see a press release? What forum in which do you plan to commentate or provide guidance or thoughts on this NCD when and if you're prepared for it to do that?

Yes, it's a fair question, Jason. Right after this call, we'll get into this and we'll dig pretty deep. We're not sure what the best way to communicate is. If we think that we can answer sufficient questions for investors with the press release, then we would do it. If it was something that we thought was complex enough that required a call, we would set something like that up. In terms of our actual response to CMS, of course, we would prepare an extensive response within this 30-day public comment period.

Great. Last question. Your guidance for U.S. TAVI sales in the first quarter, what percentage of that do you expect to be in the PARTNER II trial, the clinical setting? And what percentage sort of is either stocking orders or sell-through on the commercial side?

It's a minority portion of that. The clinicals probably account for, I don't know, 20%, 25% of those sales.

Our next question comes from the line David Roman from Goldman Sachs.

Just wanted to see, Mike or Tom, if you're going to provide backward-looking details on the breakdown of previously reported transcatheter sales in Europe versus clinical studies. So I think one of the piece of confusion in the quarter was the underlying growth rate there relative to what we've seen in the past.

Yes. I just try -- and maybe I can at least give you the headlines on it to get you close to it. The full year, we reported it $334 million. Within that, U.S. clinicals probably accounted for around $20 million. The rest of the world was probably around 10% of that number, so think $30 million or something, plus or minus that range. U.S. commercial, just under $10 million. So it helps, hopefully, with those pieces of data. It helps you back into what the baseline is.

Yes, that is a helpful starting point. And maybe just while you're answering the previous question regarding 150 to 250 centers. Can you just maybe walk us through and remind us how you came up with that number? What sort of the top-down build was to figure out what the right number of centers to approach was? Maybe beginning with sort of the who you look at overall addressable market and why that is an appropriate number?

We've always been driven by great clinical results, and that's going to continue to be our mantra and our top priority as we roll this out. We actually probably have the capability and possibly the interest of even going faster, given that we could stay at a very high procedural level. So we're at a number much larger than that at one time in terms of what we were thinking. But there's a little bit of push back on the part of societies that said, "Hey, can you really maintain the high quality of that sort of rate?" And so this was through some discussions that we felt very comfortable that 150 to 250 number of additional centers was going to be an appropriate rate for a first-year rollout. So it's a bit of a negotiated number, if you will. I don't know if that gets at your question.

Well, would you be willing to put a number on that, sort of, what percent of what you think the ultimate addressable number of centers is?

Well, that's a great question. I mean, how many centers will actually be doing TAVI when the smoke clears 5 years or 10 years from now is a very -- it's an uncertain number. We know that there are approximately, let's say, 1,200 or so centers that are doing open-heart surgery today. And we would imagine that would be something in maybe half that or less than half of that that end up doing transcatheter heart valves in the long run. But this one is a very difficult number to try and pin down. It's uncertain, and I think there's a variety of views out there. And there'll be some discussion between societies and regulators that will ultimately determine what that looks like.

Okay. And then lastly for Tom. If you look at the pacing of earnings throughout the course of the year, which you gave very explicitly at the analyst meeting. It really is sort of a tale of 2 halves, first half and first second half as the SG&A number start to ramp down. How should we think about, sort of, the normalized earnings power of the business with the commercial U.S. TAVI program? Is that -- is fourth quarter the right way to look at it? Is it the blend of the second half? Just to get a sense as to when we'll start to see a more normalized run rate. Thomas Abate;Chief Financial Officer, Principal Accounting Officer and Corporate Vice President: Sure. I have to say, if you're looking forward, probably Q4 is your best indication, right? What you're facing is a lot of investment that was made upfront and a pretty dramatic ramp is we had centers each quarter. So each quarter, we're looking at a bigger sales number, obviously, and expenses not going as fast. So I'd say, the exit rate is probably the best indication, but I would think that you still got improvement going forward from there. We will continue to invest in everything, but I think those expense ratios will grow slower than sales for the foreseeable next couple of periods.

Our next question comes from the line of Larry Biegelsen from Wells Fargo.

Just one clarification, Tom. The $17.6 million in special charges related to Southern European receivables risk, that did not affect sales in the quarter, is that correct? Thomas Abate;Chief Financial Officer, Principal Accounting Officer and Corporate Vice President: No. And, Larry, only I think it was -- $8.8 million of that was receivables related.

I mean, anyway, based on the numbers you've given us, it does look like the o U.S. TAVI sales were relatively flat sequentially, up just slightly, which is different from what we've seen in the fourth quarter typically. Mike, I know you've gone through the reasons for that. But help us understand why you would expect it to recover? I mean, did they run out of budgets in the fourth quarter, and you see budgets, new budgets for 2012?

Yes. Typically, you would say Europe in total -- it's a good observation, Larry. Europe in total would've been grown at a pretty rapid pace throughout the year, something in the 40% to 50% range in terms of total market. And here in the fourth quarter, it slowed down a lot. And that's because we actually had countries that went into negative growth. They were actually lower in the fourth quarter of '11 than they were in the fourth quarter of '12. These are the Southern European countries that actually we had a fair amount of volume in. It's not the largest in Europe, but enough certainly to affect the growth rate. Now you're asking me to see the future in terms of what's going to happen in those countries. We know that there's patients that certainly want transcatheter valve procedures, and we would expect this to begin recovering. But it's difficult for us to predict exactly when that might happen. Thomas Abate;Chief Financial Officer, Principal Accounting Officer and Corporate Vice President: Yes. And, Larry, it was not really flat. It was probably maybe more in the range of the 20% growth. And, sorry, there were a couple of pieces that make that hard had to trace, but I'd say somewhere in the 20s, low 20s is not a bad number for Europe.

Tom, you're seeing 20% sequentially or 20% up year-over-year? Thomas Abate;Chief Financial Officer, Principal Accounting Officer and Corporate Vice President: Year-over-year.

Okay. I know you haven't had a chance to look at the NCD, but there's one number that has been thrown around there before. I'm wondering if you know if offhand. How many centers in the U.S. do over 50 aortic valve procedures per year? Does anyone know that offhand?

Yes, offhand, Larry, there's around 400 centers in the U.S. that do around 50 AVRs historically.

Okay. Last for me, the cap data that we just saw, the transapical cap data, I don't know if this was asked earlier, but just to confirm, you will be providing that to FDA and you would expect that to be part of a panel?

Yes, Larry, you have to promise that's the last question. But, yes, of course, we will provide that cap data to FDA.

Our next question comes from the line of Mike Weinstein from JPMorgan.

Mike, you had commented at the analyst meeting on the trajectory early on in your expectations. And you had said that you thought January would come in for U.S. JV in sales in the $10 million to $15 million range. Is that where it played out?

That probably came in -- we probably came in a little short of that. I think some of this temporary conversion caused it to be a little short of where we thought it would've come in.

So in your mind, the push back from a couple of those local carriers that you and I had talked about, that probably has changed the trajectory of the slope for 2012, but hasn't changed where you think you will end up in total for the year?

Well, I think it ends up changing -- yes, it ends up changing the trajectory here in the short term. And until there's national coverage determination, and I'm optimistically hoping that this document which was published today starts providing some clarity. But the interim period appears that it is -- the ramp is affected by this uncertainty. But you can see because we are reaffirming our full 2012 numbers, we're still feeling confident that as this gets cleared up, that we'll be able to get back on that ramp and stay in our range.

Okay. Let me just ask a couple of quick follow-ups. One of the questions people have is the play back and forth between the TAVI ramp and the surgical valve business. And it's tough to extract out the impact of obviously competitors launch and how that's impacted your business. But if we look at your constant currency, either your surgical valve growth over the course of 2011 or the total company growth that's TAVI for 2011, so if I looked at total company, it was 8% in the first quarter, 4.9% in the second, 3.7% in the third and 1.3% in the fourth. That suggests that x what's happening on the TAVI side of the business, the other part did decelerate. And can you just comment on the confidence level on that reaccelerating in 2012 because the guidance does imply some reacceleration.

No, that's a good point. And I hear the stories that those numbers tell, but this a little bit -- there's a little more going on besides that. The first quarter of last year, for some inexplicable reason, we saw a very high procedural growth across the board. So that was that. Then we saw competitors come in for the first time in the second quarter. That suppressed growth rate for a while. And you could see that, that had some impact during the year. And toward the tail end of the year, we felt that the economy, in general, sort of slowed procedure. So you have 3 things going on there. I think that when we anniversary this competition that it's -- we're going to get a list out of our growth rate out of that. And we don't think that people save up heart valve procedures forever. So we expect there to be some lift. On top of that, just the introduction of transcatheter heart valves in the U.S., we think, actually is a stimulant to surgical heart valves in total. We think it's going to bring patients into the system. And if our experience in the U.S. is somewhat like our experience in Europe, there's another reason to believe that the growth rates will be higher in surgical going forward. There's also -- we expect to get INTUITY, that probably adds another, I don't know, maybe, 1% to the growth rate as well. So if you put together, we think we've got pretty good reasons to believe that 3% to 5% is solid.

Okay. I'll just one quick one on the NCD, and if you happened to look at this, I'd appreciate it. But maybe you can just give us some thought. One item that did catch me that I hadn't heard of or thought of before was that a requirement for new centers to be considered for TAVR was that the interventionalist has to have experience doing at least 50 structural heart disease procedures prior to this. And I just don't know where they would get that experience of doing 50 structural heart procedures unless they've been active doing ASDs, VSDs, PFOs. Is that something that you would've heard of or surprises you? Because I would assume that hasn't been a requirement to date, the centers you've been going to.

Yes, you've correctly anticipate that I'm not able to really analyze what they said. No. Although there has been conversation right along, Mike, that this should be done by experienced surgeons and experienced cardiologists, and there have been different kind of numbers going around. This is the first thing that I've heard of a number of a certain number of structural heart procedures. So that is new from our perspective. But the good news is, we're going to have a comment period. We're going to be able to get into those and really talk about the challenge, potentially the logic associated with some of the assumptions.

Our next question comes from the line of Glenn Novarro from RBC Capital Markets.

Two questions. One, I just wanted to come back to international sales. If you take out -- and this is for SAPIEN, for TAVI, if you take out the U.S. numbers for 4Q, your o U.S. sales were about $76 million. And to kind of get to the mid to high point of your TAVI forecast worldwide for 2012, it looks like the international number has to do between $90 million and $100 million, in that ballpark. So how do we get from doing somewhere around $75 million in international sales in 4Q '11 to getting to $90 million plus per quarter in 2012? That's my first question.

Yes. I'm not sure I followed your math perfectly, so I apologize for that, Glenn. We do think that even though Europe has grown substantially and we know that growth rate won't persist forever with just a little bit of large numbers, they're still going to be pretty good growth. We would imagine international growth would be in excess, just the market itself, in excess of 20%. So I don't know if that ends up solving for what you're trying to get to from the $75 million to the $90 million, but we would think the market growth would do that by itself.

Okay. Well, that's what I have in my model, but it just -- on a sequential basis, to go from 4Q into 2012 does require a step up. Well, let me ask you just one other question on the advisory panel. At STS, Dr. Smith said he thought the panel would be April, May. Now I don't think he has an edge. But I'm just wondering, is an April and May panel more realistic? In other words, the cap data is going into the FDA, they want to review that data, and it's for that reason that a panel, maybe, is a little bit later than expected?

Yes, I was in the audience as well when Dr. Smith said that. I have no reason to believe that he has any inside information. I think that was his own estimate. We really -- frankly, we really just don't know. We've been estimating that it'll be in the first quarter. And for modeling purposes, we will assume that we would get the approval for Cohort A in midyear. And so as the panel comes a little earlier, a little later, it's really tough for us to be able to estimate. It's really up to FDA and the availability of the panel members. And so I'm sorry, but I can't give you much more insight.

Our next question comes from the line of Miroslava Minkova from Leerink Swann.

Let's start by -- I appreciate you don't have a comment on the National Coverage Decision. But theoretically, were you expecting that 2-surgeon reapprovals would be required in inoperable patients? And how would that change your assumption -- adoption assumptions basically?

I haven't seen it. And so if you say that there's 2 surgeons in there, I'll take you at your word there. For us, we frankly didn't know what the FDA label would say. It might have also said 2 surgeons. We don't think 2 surgeons is a big negative for this procedure. We think, in general, there are 2 surgeons that are going to be associated with this at all time. That's what was trained. That's when -- we had The PARTNER Trial itself, it took 2 surgeons. So don't look at that as a big negative.

Okay, great. And finally, maybe -- I know you've been asked a lot of questions in Europe. But I think what's probably still confusing people is the currency is a little bit more negative than the time you gave guidance, the euro has weakened and your fourth quarter wasn't quite as stellar because of weakness due to macroeconomic conditions. I guess, maybe if I could ask what gives you the confidence to maintain the, sort of, the overall TAVR guidance that you're giving? Or said differently, were you assuming this kind of a tough environment in Southern Europe when you did give the guidance last month?

Yes. If you go back to our investor conference, Miroslava, we actually put a slide up that anticipated sales. And that sales number actually said that the bottom end of our range, and I forget what slide number it was, but we pretty much landed exactly on that number. So we had a pretty good idea of what the climate was by the time we got to our December investor conference. We did not have that same visibility back in October, but in December, we were pretty close. Is that fair, Tom? Thomas Abate;Chief Financial Officer, Principal Accounting Officer and Corporate Vice President: Yes. And the FX got worse by about 20 since that time. And I'd say half of that probably is going to be hitting THV Europe sales. So within $10 million, you should be close in FX impact.

You're basically assuming that some of these procedures that were -- did not happen should come back, perhaps, as we go into the new budget year?

Yes. I would say that we're still standing by our guidance, Miroslava, for what we have for 2012. So, of course, there's going to be a ramp. It's tough for us to predict, but we think our guidance anticipates both some of the natural FX fluctuations, as well as some of the uncertainty that's around when these countries' restore procedures.

Our next question comes from the line of a Bruce Nudell from Crédit Suisse.

Mike, on a happy note, the cap data really showed amazingly good neurological outcomes. Do you have any feel yet of what the secret sauce in that was?

We don't, that is the short answer. I mean, obviously, I think it's a by-product of experience. So a combination of factors. We think patient selection probably was better. We think operator experience in procedures was better. We think the devices were a little bit better later on in the trial as well. So it's a combination of factors. It's tough for us to say which was the most important factor, and we expect to learn more about that in our PROTAVI trial.

And I guess, a follow up, Mike, and we've talked about this before. If unit growth in Europe is around 20% now. We thought x U.S. unit growth in aggregate was about 30% for the market last quarter. Does that tell you anything about the idea of, like, how many people are sitting on the sideline, the ability to recruit unreferred patients now, the fact that the market, probably at the beginning of the year x U.S., was closer to 50%? Any thoughts on that?

Yes, we probably think that -- we continue to believe that there's a lot of patients that are on the sideline. It's probably economic factors that's the greater issue. When we see a country gain reimbursement, you see the patients in those countries come for the procedure. And we think that's probably the more significant underlying factor that unlocks the ability of these patients to get treatment.

Our next question comes from the line of Amit Bhalla from Citigroup.

This is Adam [ph] in for Amit today. I just have a question on rest of world. I know the growth rate there decelerated just as much as in Europe, so I was wondering if you want to go into a little more detail as to what happened there?

In rest of world? I don't know. Those numbers tend to be smaller. I don't know if I could pick up a growth rate on that, Adam. Maybe you have something a little bit more specific? Our rest -- what we call rest of world, so again, if you take out U.S. and you take out Europe, the growth in the fourth quarter was very similar to the full year growth. So...

Okay. Well, maybe just on any, kind of, segmentation by product. Was there anything, in particular, going on there that was different from expectation?

Is this Edwards in total that you're talking about, Adam, or any particular...

Yes, Edwards in total.

Okay. let me try and look more closely and see if there's something that I can attribute it to. Yes, it looks to us, just looking at this quickly, our quarter-to-date and our year-to-date growth rates in rest of world are very similar. They look they're like within about 1% of each other. So it's not something that's jumping off the page. So we're happy to work offline and see if there's a more detailed understanding we can provide.

Our next question comes from the line of Kristen Stewart from Deutsche Bank.

One quick one, and then I have a follow-up. I know that cap data on TA was really superb. I was just wondering when might we be able to see the cap data on transfemoral?

Yes, I don't know that that's going to be presented publicly before a panel. I don't know if that's available. I mean, that certainly is being worked up by us, and we would plan to bring that kind of data to the panel if we can possibly do that. But I don't know if that it's going to be in a public forum before then, Kristen.

So that won't be something at ACC along with the 2-year data?

I don't know that it will be at ACC. Again, we'll see what happens. As far as I know, ACC will just have the 2-year data that's particularly within the PMA.

Okay. And then I know that you have not looked at the NCD, but I was just wondering, in formulating your guidance for transcatheter valves for 2012, I was just wondering what you were thinking about in the context of potential risks to that, specifically in terms of centers having to qualify in certain criteria? Does this really add an element of risk? Because I imagine if I'm a center looking to start up TAVI and I'm looking at all these criteria, I may just want to wait to see how that shakes out before really making the level of investments in buying the valves and getting all the training up and running. So maybe just walk through how you were thinking about that in terms of maybe applying different haircuts to the guidance. And then also, just on the sales. It looks like they're proposing to restrict coverage to patients with coronary artery disease, which is consistent with PARTNER, but seems to screen out quite a bit of patients if you look at the STS database?

Well, you're ahead of me when it comes to the analysis of what was published, Kristen, so we can't really comment on that. We can talk about our assumptions. Obviously, we gave a range because there's a range of possibilities. Probably, the 2 biggest factors that are in our assumptions, we've assumed that we would train 150 to 250 hospitals, and so there would be a natural ramp associated with that. Obviously, that builds upon itself, and so gets much bigger in the back half of the year. And the other thing that's in that assumption is an approval for Cohort A in midyear. So if Cohort A were approved earlier or later, that would change the numbers. If there was something within the document that you're referencing, that causes the 150 to 250 hospital ramp to change significantly, that would also have impact on our range.

So the 150 to 250, you didn't necessarily expect any formal restrictions in terms of which centers you could go after. That was just your [Audio Gap] centers? But probably aligned.

Well, what we're trying to do is to summarize that we thought we would train 150 to 250 centers. We knew that it wasn't going to be a center only kind of criteria laid out by the societies in CMS, that there would be some specific criteria or credentials for physicians into it, but we thought that, that would allow 150 to 250 centers. And so that's what we'll be analyzing when we get into it.

Our next question comes from the line of Tom Gunderson from Piper Jaffray.

On PARTNER II and its impact on your U.S. guidance numbers. If we look at -- you've already fully enrolled B, so if we look at A and its roughly 2000 patients, and it's a one-to-one randomization, and you said in your prepared comments that you expect full enrollment in 2013. Is the math correct to assume that somewhere around 500 SAPIEN XT patients would be enrolled in 2012 and that, that's part of your guidance?

I think that's a reasonable estimate. Of course, remember, there's also a ramp associated with P2 a. But, yes, I think that's a reasonable estimate.

And then you mentioned this to one of the other answers, Mike. But I call it the halo effect, where you get more sAVR just because you're out there talking more in the valve team, et cetera. Is that a passive increase or do you have specific programs that you're focusing on to capture as much of the market as you can because of the attention that TAVI is getting?

Yes, well, let me -- first historically, it's been passive. So what we saw in Europe, and I don't know if you recall the slide that I think either Larry presented at the investor conference that talked about the fact that the growth of the market both -- doubled after the introduction of transcatheter heart valves. I think it went from the 3 range to the 6 range. And then in particular for Edwards, our growth rate stepped up from 5% to one that was more than 10%, I think, close to 13%. And so that happened in Europe. In the U.S., we do have some more active processes where we're helping hospitals establish valve clinics. And this is a cooperative effort between our heart valve team and transcatheter heart valve team. They just help people -- help hospitals do a good job of treating aortic stenosis. And so there may be some positive effect, but I would say that the underlying effect is the more predominant one.

Our next question comes from the line of Spencer Nam from ThinkEquity.

Just a couple of quick housekeeping questions, I guess. First on this NCD. Is there going to be another decision document coming out from CMS in the next couple of months in terms of proposed rates and things like that? Should we expect that?

So, yes, our expectation -- this is the document that we were anticipating. I think they have something, Spencer, that was shown on their website that we anticipated this draft document might come at the end of the first quarter. So the fact that we're getting in on the 2nd of February just moved that up. And then there's a natural part of this process, which is a 30-day comment period, and then actually, the publishing of a formal document. We think that's going to be the primary output from CMS. I don't know that there's anything else that's going to coming beside that.

You guys -- your interpretation is that there's not going to be a specific -- the reimbursement rate-related document following this coverage decision criteria?

Yes. There already has been some determination early on here that we were mapped to some surgical DRGs. But I think the national coverage determination will actually not have anything that changes that mapping process.

Okay. And then second question is, this ACC 2-year follow-up data, what sort of -- this is going to be just a continuation of the data that we saw last year on Cohort A and whether -- or is it going to be more select data from that analysis? And do we -- should we expect the data to be also included as part of the panel, upcoming panel?

Yes. No, I think if you take a look at the -- I think what you're going to see is that the patients that received transcatheter heart valves, what was reported in the past was simply their one-year data. So these are the patients that are -- that were randomized in the trial. So that was 699 patients, I think was the number was in Cohort A. And then there was the numbers that were in Cohort -- just like for Cohort B that what we saw at the TCT. This will be what you for Cohort A. You'll see 2-year data on that group of randomized patients. So for example, within that are the 104 or 103 TA patients, et cetera. That'll all be extended out to 2 years. Is that clear? Did I answer that?

Yes, that's helpful.

We have run out of time for questions. I'd like to hand the call over back to management for closing comments.

Okay. Thanks, everybody, for your continued interest in Edwards, and I appreciate your patience associated with the questions on the NCD. Tom and David and I are going to welcome any additional questions by telephone. Back to you, David. David Erickson;Vice President of Investor Relations: 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, use account number 2995 and passcode 387244. Additionally, an audio replay will be archived on the Investor Relations section of our website. Thank you very much.

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.