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Edwards Lifesciences Corporation (EW)

Q4 2008 Earnings Call· Tue, Feb 3, 2009

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Transcript

Operator

Operator

Greeting ladies and gentlemen and welcome to the Edwards Lifesciences Fourth Quarter 2008 Earnings Conference Call. At this time, all participants are in a listen-only-mode. A question and answer session will follow the formal presentation. [Operator Instructions]. As a reminder this conference is being recorded. It is now my pleasure to introduce your host, Mr. David Erickson, Vice President, Investor Relations. Thank you, Mr. Erickson, you may begin.

David K. Erickson

Analyst · Credit Suisse

Welcome and thank you for joining us today. Just after the close of regular trading, we released our fourth quarter 2008 financial results. During our call today, we'll focus our prepared remarks on information that complements the material included in the press release and 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 and Treasurer. 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, sales, gross profit margin, net income, earnings per share, and free cash flow goals for 2009. The regulatory approvals and sales of Heart Valve Therapy products including Magna Ease and Magna Mitral Ease, the competitive dynamics of the Heart Valve market, the timing, progress, and results of clinical studies including the PARTNER trial, the continued adoption in Europe, and expected 2009 sales of the Edwards SAPIEN valve. The expected sales and enhancements for the FloTrac system and the development of continuous blood glucose monitoring technology. 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 actual results to materially differ from those in the forward-looking statements may be found in our press release, our annual report on Form 10-K for the year ended December 31, 2007, and our other SEC filings which are available on our website at edwards.com. With that, I'll turn the call to Mike Mussallem. Mike?

Michael A. Mussallem

Analyst · Canaccord Adams

Thank you, David. 2008 was another successful year for Edward’s on several fronts. We achieved substantial earnings growth, successfully introduced the SAPIEN, transcatheter heart valve in Europe and continued to make substantial investments in our future. This is our best year yet for top line growth with total underlying sales for 2008 increasing 12%. In Heart Valve Therapy, we introduced our Magna Mitral Valve in the U.S. and our Magna Aortic Valve in Japan. During our first year of Transcatheter Heart Valve sales in Europe, we achieved $53 million, which was significantly above our initial estimate of greater than $20 million. We continue to make great progress on our U.S. clinical trial and began a CE Mark trial in Europe for SAPIEN XT, our next generation Transcatheter Heart Valve. At the same time, FloTrac continues to generate solid growth within Critical Care. In addition, we unveiled our continuous glucose monitoring plans, which represent a potential new growth platform, and lastly, we successfully integrated the CardioVations MIS product line. Just to recap our 2008 financial goals, excluding special items, our total sales reached $1.24 billion, exceeding the top of our range of 1.21 billion. We improved our gross profit margin by 90 basis points, which was just below our 100 to 150 basis point goal. Our net income growth of 16.2% exceeded our 11 to 14% range and free cash flow for the year of $166 million achieved the top-end of our goal. Now, turning to fourth quarter results, on a reported basis, total sales grew 5.7% or $310 million and grew 13.2% on an underlying basis. Overall, we were able to achieve excellent sales results and we are fortunate to see a little impact in the fourth quarter from the economic downturn Now I’ll shift to a more detailed review…

Thomas M. Abate

Analyst · Wachovia securities

Thanks Mike. In addition to the strong underlying sales performance that Mike reported, our fourth quarter results were further enhanced by a 210 basis point improvement in our gross profit margin. We are very pleased to see this significant upward movement in our reported rate. In the quarter, we were able to further leverage the combination of sales growth and the gross profit improvement to lift our non-GAAP diluted EPS growth to more than 39%. Additionally, we are very pleased to achieve a full year non-GAAP diluted EPS growth of approximately 20%. Before I go through the P&L I would like to spend a minute on the accounting treatment for the retrieval of our repair products. Our GAAP results include an approximate $5 million reductions to sales, gross profit and pretax income. This estimate represents the sales value of all products impacted by our action, plus the cost of executing the retrieval. Upon receipt of FDA’s clearance, the product will be returned to customers and a sale will be recognized in the future period. To-date we have contacted approximately 90% of the customers affected by the retrieval and the vast majority have simply asked us to return the product when we received FDA clearance. So far, we have only been ask to issue credits totalling $500,000 On our non-GAAP results reflect only these credits and not the full $5 million estimates in our GAAP results. Going forward, when we return these products to customers we will not record a sale in our non-GAAP results. We believe this offers the clearnest comparison of sales and earnings between periods. Moving forward we recorded diluted EPS for the fourth quarter of $0.66 compared to $0.27 last year. Excluding special items and the impact of the product retrieval our first quarter non-GAAP EPS was…

Michael A. Mussallem

Analyst · Canaccord Adams

Thanks, Tom. Overall we expect to carry our 2008 momentum into 2009 and deliver a strong results while making substantial investments in our future. In Heart Valve Therapy, we anticipate launching two new valves in the U.S. and doubling our SAPIEN Transcatheter Heart Valve procedures. In critical care, we have planned for additional extensions to our FloTrac systems and hope to introduce a continuous glucose monitoring systems in Europe by the end of the year. And lastly in 2009, we anticipate completing enrollment in our U.S. PARTNER trial and gaining the U.S. IDE for the approval of SAPIEN XT. We are going to remaining focused on achieving our previously stated financial goals which include generating total sales between $1.24 and $1.3 billion increasing our gross profit margin between 68 and 70%, achieving diluted EPS growth of 15 to 19% and generating free cash flow of $160 million to $170 million. And with that I will turn the call back over to David.

David K. Erickson

Analyst · Credit Suisse

In order to allow everyone a chance to participate we ask that you limit the number of questions that you ask. If you have additional questions please re-enter the queue and we'll answer as many as we can during the remainder of the call. Operator we're ready to take the questions, please to allow everyone a chance to participate we ask that you limit the number of questions that you ask. If you have additional questions please re-enter the queue and we'll answer as many as we can during the remainder of the call. Operator we're ready to take the questions, please.

Operator

Operator

Thank you [Operator Instructions] Our first question is coming from Jason Mills with Canaccord Adams. Please state your question. Jason Mills – Canaccord Adams : Thanks guys. Congratulations on a good quarter. My first question Mike is out of Europe and is specific to the SAPIEN franchise. You mentioned, reiterated plans to double procedures year-over-year. I’m wondering if you could help us out a little bit with same-store sales growth implicit in this expectation in an addition to that, your new center expansion update. I am really trying to get - I think for the last few quarters you’ve mentioned pretty strong growth and procedures or implant as a percentage of the total sales that you’ve reported and I’m wondering if we sort of look at the expectations you’ve given for 2009 if we are seeing much in the way of center expansion implicit in your guidance? Thanks Mike.

Michael A. Mussallem

Analyst · Canaccord Adams

Yeah, thanks Jason, yeah again, maybe the most important thing that we’re saying as we’ve set a goal to actually double procedures next year. Some of them will come from new centers. We expect to add new centers, I don’t know exactly what that will workout to be. We said we have approximately 100 centers in planning in the fourth quarter, maybe we’ll add somewhere in the 50 to 100 range again next year. But we certainly expect there to be growth within the existing centers as well and that’s sort of net to a doubling of procedures. Does that get at your question Jason? Jason Mills – Canaccord Adams: It’s helps. I know that there were more sort of “stocking” probably in the first quarter and half of launch in earlier in 2008, but I’m wondering for the full year percentage of implants relative to sales is it’s sort of 65%, 70% in 2008. Can you give us some feel for the number in 2008 so that we can sort of extrapolate forward the mix between center revenue and sort of “same-store” sales revenue in 2009?

Michael A. Mussallem

Analyst · Canaccord Adams

Yeah, just for clarification, our practice has not changed. It was just more obvious in the first quarter when we were adding centers, before we had a run rate going, because where we are both Transapical and Transfemoral and we have two sizes on each people were typically putting the complete compliment on the shelf Jason Mills – Canaccord Adams: Okay.

Michael A. Mussallem

Analyst · Canaccord Adams

As they got started and that was one of the requirements. I’d say full year probably worked out the procedures equals about 70% of sales, maybe a little higher than that for full year and we’d expect that to continue to decline as we have a more mature business. Jason Mills – Canaccord Adams: Okay, so just before I get, one question for Tom before I move on there. If I kind of take that number, then we are looking at sort of $35 million in implants sales, $35 million, $40 million doubling that assuming ASP’s are stable you already getting to the lower end of your range before you add sort of new centers and stock into those centers, is that, am I thinking about that right? Thomas M. Abate You lost me with the reference to $35 to $40 million, what we are referring to that? Jason Mills – Canaccord Adams: Well if I take sort of 70% or something like that implants relative to $53 million you reported? Thomas M. Abate I think that there is number of factors when you convert everything into dollars, not least of which is Jason, primarily the sales are coming out of Europe, and are going to be a affected by the euro or so. Jason Mills – Canaccord Adams: Okay. Thomas M. Abate So, at the end of the year, the rates have changed dramatically. So that you need to factor that in but, we feel good about the dollar range that we gave and I think that’s probably the best way to think about it at a high level.

Jason Mills with Canaccord Adams

Analyst · Canaccord Adams

Great. And just one question for you and I’ll get back in queue. With respect to the R&D, you’re obviously expecting to ramp the spending in 2009 largely driven by the CGMS project. I’m wondering if you see any slippage in product development here, not to say that there will be but certainly that is an area that that will require a lot of development and perhaps projects could be pushed out. I’m wondering what is sort of implicit in your guidance for that if you see some slippage in product development on that side, I guess I’m asking would that drop down into the bottom line and perhaps be accretive if there again if some slippage here and there which I don’t think would be out of the realm of possibility given that it is somewhat of a new area?

Michael A. Mussallem

Analyst · Canaccord Adams

I think that Jason. It’s Mike. I think we have fully accounted for what we think spending is going to be in 2009. So the spending is all in there and when you take a look at products like XT and glucose that really not in terms of much in the way sales or gross profit. So it’s not really a downside exposure, if that’s what you are getting at during 2009, of course it would affect future periods. But we’re expecting to execute at a high level.

Jason Mills with Canaccord Adams

Analyst · Canaccord Adams

I’m actually asking perhaps if there could be some accretion to the bottom line given that..

Michael A. Mussallem

Analyst · Canaccord Adams

R&D savings you’re referring potential R&D savings?

Jason Mills with Canaccord Adams

Analyst · Canaccord Adams

That’s right. Not spending as much as you factored in.

Michael A. Mussallem

Analyst · Canaccord Adams

It’s not in our current calculation Jason I think that would be being, I don’t know optimistic whether you’d call it optimistic or not, but no that’s not really in the plans. Jason Mills – Canaccord Adams: Okay, thanks guys.

Operator

Operator

Our next question is coming from Kristen Stewart with Credit Suisse. Please state your question. Kristen Stewart – Credit Suisse: Hi thanks for taking the call or questions. On Magna Mitral did you give a number for what that contributed in the quarter or what FloTrac contributed in the quarter as well from a sales dollars perspective?

Michael A. Mussallem

Analyst · Credit Suisse

Yeah we didn’t. Magna Mitral, I think we sold something in the neighborhood of $5 million in the quarter, but the bulk of that Kristen would have been replacement of our existing products with an upgrade to Magna Mitral. So incrementally it probably only added a little over a $1 million in the quarter. So it wasn’t a big contributor, certainly a contributor in the U.S. and in the mitral position but in aggregate not that much. The FloTrac I think the question was how much for the quarter? Kristen Stewart – Credit Suisse: Yeah.

Michael A. Mussallem

Analyst · Credit Suisse

Or for the year? Kristen Stewart – Credit Suisse: For the quarter.

Michael A. Mussallem

Analyst · Credit Suisse

Okay, well. I think for the quarter it was a little north of $15 million. We did more than $50 million in the year and it was an increasing progression. Kristen Stewart – Credit Suisse: And then just two questions or housekeeping. The other expense item jumped up about $4 million, what was in that and then just reconciling back to the gross margin are you adding back 4.7 into sales to get to the (inaudible) like how are you what's the mechanic side?

Michael A. Mussallem

Analyst · Credit Suisse

Are you referring to the product retrieval on the second part, Kristen? Kristen Stewart – Credit Suisse: Yes to get to reconcile back to the adjusted number. I assume you are adding something to the shelf base and then something in the hospital leverage?

Michael A. Mussallem

Analyst · Credit Suisse

Okay, let me start with other expense, but we had two large items. One was a we referred to it back in Q3 when we give guidance that we’re going to see on that line a negative impact from FX. But that was slightly greater than half of the amount and then there was a $2 million amount, which occurred towards the latter half of the quarter that related to the valuation of one of our money market, the enhanced money markets by Colombia Strategic Fund. So we have to take it down. Now, originally we are down to total balancing that fund or something less than a 11 million and probably get 3 million of charge that we took this year. So, the net balance on the balance sheet is down to about $8 million as we are trying to get out of that fund. Does that answer the other expense question? Kristen Stewart – Credit Suisse: Yeah, that’s perfect and then just the gross margin.

Michael A. Mussallem

Analyst · Credit Suisse

And that on the gross margin, what’s in the gross margins, was penalized on the reported obviously it was affected by the what you call the charge of $5 million to sales. It is just about an equal charge to GP. We added there is a little bit on the retrieval cost we did not do a return to inventory as the inventory belongs to the customer since we haven’t issued credit. So, it’s pretty straightforward difference between the two. Now, remember on the non-GAAP, it just that was more like a half a million. And that reflected actual credit issues.

Undefined Company Representative

Analyst · Credit Suisse

I think its fair to say Tom, the gross profit rate did get depressed we are reporting here because of the retrieval.

Undefined Company Representative

Analyst · Credit Suisse

Yes, it was staying to about 50 basis points.

Undefined Company Representative

Analyst · Credit Suisse

Yes. Kristen Stewart – Credit Suisse: Okay. And with the full year tax rate at little under 23 helping to the full year for ’09 it can be closer to 24.

Undefined Company Representative

Analyst · Credit Suisse

You know, its Kristen, the question I think, it’s within the realm of possibility within 24 I think could be plus or minus 1%, very possibly it could be. This is not at the end of the year it went lower than we had originally expected, but I still think 24 is a good number. Kristen Stewart – Credit Suisse: Yes perfect. Thank you.

Operator

Operator

Our next question is coming from Tim Lee with Piper Jaffray. Please state your question. Timothy Lee – Piper Jaffray: Hey, good afternoon. Thanks for taking my question. A couple of questions here, just given the number of centers that you’re now in and given the number of centers on the SAPIEN side given the number of centers that your competitor is in. Are you going more head-to-head, are you seeing them out in the field more and how are you fairing in those bake offs?

Michael A. Mussallem

Analyst · Piper Jaffray

Yeah Tim. Our first year of introduction, largely we were staffed with just clinical resources and so we really focused on training and we focused on just helping people to get up and to do good procedures. So, it was just a lot market expansion and I wouldn’t say there was a lot of head-to-head fighting. We’re just adding sales resources at this point. I think for the most part I expect 2009 still to be a year of expansion. There will be some competition. But I don’t think there is anything to report at this point in terms of we’ll share battles. Timothy Lee – Piper Jaffray: And then just a point of clarification on the 100 centres that you are in, were they all active in the quarter or were they some centers that ran out of funding as the year progressed?

Michael A. Mussallem

Analyst · Piper Jaffray

Yeah that actually the number of centers that had an implant in the fourth quarter, there were a 100, you’d call those active centers. Timothy Lee – Piper Jaffray: Okay, and then last one here. Of these 650 plus implants that you performed during the quarter, does that include the partner trial enrollment as well?

Michael A. Mussallem

Analyst · Piper Jaffray

No, that was I think I referenced purely to Europe. Timothy Lee – Piper Jaffray: Okay. Great. Thanks for your clarification.

Operator

Operator

The next question is coming from Larry Biegelsen with Wachovia securities. Please state your question. Larry Biegelsen – Wachovia Securities: Hi, good evening and thanks for taking my call. Tom, just for clarification, can you tell us how you are getting to the $0.78 what the tax rate I think you said was 71, the gross margin is 68.6 in the release, what are the other components, is the other income, is it that 4 million that gets we are having trouble getting to $0.78.

Thomas M. Abate

Analyst · Wachovia securities

Well, it should be all into P&L as let’s say the $0.78 difference would be I think it’s what you are having is you're reconciling what was reported. We had the 68% the other expense before we considering the other expense components of this Larry? Larry Biegelsen – Wachovia Securities: Maybe it is better to do it off-line with David after the call. Just another clarification question then on restocking of 5 million, is that in your guidance for '09 the sales guidance?

Thomas M. Abate

Analyst · Wachovia securities

On the restocking, you're saying the sale as it returns to the customers? Larry Biegelsen – Wachovia Securities: Is that in your guidance for next year?

Thomas M. Abate

Analyst · Wachovia securities

No, no. And Larry let me say on the other one. There is the attachment that does the full reconciliation. So you’ve a complete list of what reconciles the two numbers. Larry Biegelsen – Wachovia Securities: Okay. I will followup on that afterwards. Let me ask my real questions then. So Transapical, Transfemoral mix in Europe. Can you tell us what that was in the quarter please?

Thomas M. Abate

Analyst · Wachovia securities

It was approximately two-thirds to one-thirds, two to one. Transapical to Transfemoral. Larry Biegelsen – Wachovia Securities: And your SAPIEN guidance I mean, just to follow up on an earlier question you did 85 in the quarter. So, you’re at a $74 million run rate, but your guidance is 75 to 95 million and I appreciate the FX, the uncertainly around FX, but it does seen conservative. Is there anything that makes you conservative in terms of reimbursement in Europe or impact from the economy?

Michael A. Mussallem

Analyst · Wachovia securities

No is that Larry, we're being conservative. We feel very, very confident obviously, putting up a quarter like this one makes us feel confident. We continue to like all the dynamics. Naturally, we're a little thoughtful about it when you have these products that are being paid for by government that are going to go through tough economic times. We're mindful of that, but no, we don't have any new facts that cause us be extra conservative. Larry Biegelsen – Wachovia Securities: Just as a last quick one. U.S. sales for SAPIEN in the quarter Mike, how much were those?

Michael A. Mussallem

Analyst · Wachovia securities

I think they have been running between, it's a little over $1 million certainly less than two, it's in that range Larry. Larry Biegelsen – Wachovia Securities: Okay, thanks. I'll get back in the queue.

Operator

Operator

Our next question is coming from David Lewis with Morgan Stanley. Please state your question. David Lewis – Morgan Stanley: Hi good afternoon.

Michael A. Mussallem

Analyst · Morgan Stanley

Hi David. David Lewis – Morgan Stanley: Hi Mike could you tell us the assumptions for Transapical Transfemoral mix as well as your Transfemoral markets share expectations that underpin 2009 guidance?

Michael Mussallem

Analyst · Morgan Stanley

Yeah, we’ve been tracking probably at this rate of 2 to 1 to Transapical versus Transfemoral We would expect as particularly as XT comes on, that we're going to be getting share in the Transfemoral position. We think that that's going to be very popular in Transfemoral and so it will cause that percentage to go up as a percentage of our sale and also causes us to gain share. The doubling of procedures, I think it is something that we can do without gaining an awful lot of share. I think most of that is there through market expansion and if that we do get substantial share gain that's probably upside. David Lewis – Morgan Stanley : Mike, what do you think Transfemoral market share would trough before launch of Nextgen? Michael Mussallem It is might have already troughed earlier this year. If anything we feel like Transfemoral share might have been improved for Edwards in the fourth quarter, it's still not that favorable for us. So I think the competitor probably has three to one in the transfemoral position something like that. So just to give you a sense for it. But, the other side of this is Transapical is doing very well and so and when we talk about these ratios and you compare Transfemoral with Transapical and we’re the only ones in the Transapical position, it sort of makes our Transfemoral now look quite as good just because of the comparison. David Lewis – Morgan Stanley : Okay and to say a couple question here. New centers that are coming on, is there any reason to believe that new centers are going to be at a relatively lower level of utilization given that you're moving down markets or that the mix of Transapical to Transfemoral would be different because you are getting, you are scrutinizing less in terms of making sure they're committed to Transapical? Michael A. Mussallem David, my recollection of all of our modeling here is there is no substantial change of the new centers compared to what we are experiencing. As you might imagine they are probably they tend to be a little smaller centers, but we wouldn’t expect much change in the dynamics. David Lewis – Morgan Stanley: Okay and then just lastly I’ll get back in queue. Tom so at least in the mix remains favorable on gross margins prove to be conservative. Are you going to spend any gross margin upside and invest in the international market for valve or would you drop that through to the bottom line? Thank you.

Thomas M. Abate

Analyst · Morgan Stanley

Well we have put in the guidance that we already had a pretty big range and expectation to possibly top out as high as 70%. We also had R&D growing over 20% to like13 and 13.5 to sales. So, I think we put in lot in the P&L. We think at this point if there were additional upside we have to look at that hard since we could find another place for it.

Operator

Operator

Our next question is coming from Mike Weinstein with JP Morgan. Please state your question. Michael Weinstein – JP Morgan: Thanks, lets begin question so as you know it’s a little bit tough to hear you guys in the room I think it’s may just be the speaker. Let me just follow up on the questions on SAPIEN first, you obviously had a very strong step up sequentially this quarter you added more than 30 centres, any reason to think that sequentially as we look at first quarter sales wouldn’t increase again.

Unidentified Company Representative

Analyst · JP Morgan

Mike, thanks for the question. Let us know here, if you if anybody ever gets an answer that you can’t hear please let us know and we will repeat it or try and make sure we get that back out to you. Sorry about that.

Michael Weinstein - JP Morgan

Analyst · JP Morgan

Thanks.

Unidentified Company Representative

Analyst · JP Morgan

There is no any reason to believe that the first quarter is not going to be a continuation of the trends lines that we’re on right now. So, nothing like that we’re foreseeing.

Michael Weinstein - JP Morgan

Analyst · JP Morgan

Can you give us any help for modeling Mike on a blended ASP for SAIPEN right now.

Michael A. Mussallem

Analyst · JP Morgan

You know, our pricing has been pretty stable, so although there might be a some country mix that changes a little bit from quarter-to-quarter so but the pricing within a country was continue to be very stable and we have been disciplined about our pricing. So, I am not sure I can give you a whole out there. We don’t expect there to be a much of a story in pricing in 2009.

Michael Weinstein - JP Morgan

Analyst · JP Morgan

That 15,000 to 22,000 you have given pretty wide range. Can you narrow it at all?

Michael A. Mussallem

Analyst · JP Morgan

Well, it’s pretty tough. We feel this early stage of the market is pretty tough for us to give something like an ASP. So we - I guess we prefer to keep it in this broad range and as we get a little bit more maturity Mike, and I think that's pretty reasonable.

Michael Weinstein - JP Morgan

Analyst · JP Morgan

Okay

Michael Mussallem

Analyst · JP Morgan

You know I think its pretty reasonable

Michael Weinstein - JP Morgan

Analyst · JP Morgan

Okay two financial items just to clarify here. The tax rate coming in at 78% for the quarter part of the R&D tax credit and other was you said adjustment to your country profit mix, obviously R&D tax credit we understand and we all know the timing of when that was implemented, so that shouldn't have surprised you guys. Why did the country profit mix come in so differently in the fourth - why was such a big adjustment and why - why did that catch you guys, off guard? Obviously it is positive in terms of how it helps the tax rate in the fourth quarter but you weren’t anticipating in the October when you gave guidance so what was the big swing in the fourth quarter that led you to make the adjustment. Thanks.

Michael Mussallem

Analyst · JP Morgan

That's a good question Mike, let me start off by saying no - we absolutely I didn't anticipate it back in December and basically as the tax department goes through all over the profitability and you’re talking about roughly $200 million of profit getting it in the right buckets by country. The adjustments and we didn’t already mention the adjustments, but it is in the neighborhood of somewhere in the neighborhood of $2 million it’s a slightly less could be a little bit more or less in that so its not a huge adjustment, but I didn’t want to disclose it specifically, it belongs in the year – it belongs to the full year rate. It just the – the way that you went through and as we did the more precise calculations at year-end it is way it turned out.

Michael Weinstein - JP Morgan

Analyst · JP Morgan

Okay then the last question. And I think we touched on, at the meeting in December that is I wanted to get your feedback on the free cash flow. Free cash flow hasn’t been growing the same rate, which your net income has been growing, and you’re guiding to flat free cash flow in 2009 versus 2008. It is one to maybe just to understand that a little bit better, thanks.

Michael Mussallem

Analyst · JP Morgan

Oh, sure. You know if we focus just on the difference between 2008 and 2009 and between first off let me say, I think we’re fortunate, we have a very cash rich business and it very consistent and we’ve been very fortunate in that regard. In your comparison of ’08, you need to remember that 2008 performance was relatively weak and the incentive pay out fall into the following years. So where we paid under target for 2007 that fell into the 2008 it was an upsize and the 2008 performance, which was above target falls into 2009. The difference between an under in one year and the average in the other year was 10 under and possibly 15 to 20 on the overhead side. That maybe to put those to together when you’re preparing to two years so, so pretty significant impact and another thing I’d say working capital, I am very pleased with the all of the elements of working capital and the basic of what’s being driven by the operation. So nothing to report there concern capital spendings pretty much inline, so if you look at DSO’s and things that are critical to generate future cash flow everything seems like it is in great shape that seems to be the number one exception.:

Michael Weinstein - JP Morgan

Analyst · JP Morgan

Okay, thanks David.

Operator

Operator

Your next question is coming from Amit Bhalla with Citigroup. Please state your question. Amit Bhalla – Citigroup: Hi good afternoon. I wanted to ask you a couple of questions on Critical Care. The Critical Care number came in a little bit later than our expectation, so I wondered if you go a little more detail about the impact of the hemofiltration supplier issue, what was the dollar impact there and can you also clarify the $13.2 million charge for the purchase of a Critical Care monitoring technology, I think I may have missed that?

Michael Mussallem

Analyst · Citigroup

Okay, yeah. I think if we, what we trying to signal at the Investor Conference and as that we’re having some suppliers, our suppliers were struggling and we would had a real strong year prior in hemofiltration and that’s probably $1 million easily that it would cost us in the fourth quarter. You’d also just heard about we were also concerned actually, that it was going to be tougher than this on the capital side but it actually worked out to be pretty good. But I think the thing we keep in mind as we had adjust the – our blowout quarter in Q4, 2007. And so it made the comparison tough and we anticipated that going into it but overall we weren’t too disappointed with the way things turned out. In terms of the monitoring technology, we were able to buy some technology that there is a couple thing for us. One, it is a great enhancement to FloTrac. And in particularly it helps FloTrac as we want to move into the medical ICU and so we’re going to be incorporating that matter of fact expect a launch our product later on in 2009. Additionally, we would came along with that is very neat hardware, which gives us a hardware platform for the future and allow us to potentially consolidate a number of these items. I think we’re able to mention all these in December conference and Tom might be will have details on the schedule so, I hope that wasn’t surprised anyone. Amit Bhalla – Citigroup: Okay, thank you. And on the Heart Valve Therapy side, are you still getting even though you have got a $5 million of Magna Mitral contribution in the quarter. Where you still getting about 10% to 20% price premium there and can you give us an update on Evolution II trial enrollments?

Michael A. Mussallem

Analyst · Citigroup

Yeah, sure Amit. First of all in terms of the premium yes, we’re getting a premium on Micro Magna. It’s probably in the 10% range and so, we are pleased with that and we look forward to that ramping up during 2009. In Evolution II, we are actively screening right now for that trial so, this is one that we look forward, getting enrolled here in the full path and getting some results reported here before the end of the year. So, we look forward to really getting some result but we’ve got sides that are actively screenings patients as we speak.

Operator

Operator

Your next question is coming from Josh Zable with Natexis Bleichroeder. Please state your question. Josh Zable – Natexis Bleichroeder: Hi, guys, congrats on a great quarter, and thanks for taking my questions here.

Michael A. Mussallem

Analyst · Natexis Bleichroeder

Surely Josh. Sure, thank you. Josh Zable – Natexis Bleichroeder : A Couple of housing keeping item here, real quick sorry about that, first just on the foreign exchange, I know obviously it bounces around and charge for you guys actually predicted I’m not asking to do that but given that kind of where at the guidance call here, we had a December meeting and October guidance, I’m just trying gauge because foreign currency bounces around so much and we’re fortunate to get a lot of updates I’m just trying to understand, can you give us range or sort of how we should think about it, because I know you said look to the high end of the range but if currency kind of fluctuates just so we’re sort of prepared for what kind of moves, it will be?

Michael A. Mussallem

Analyst · Natexis Bleichroeder

Well, we try to do it as we said today’s rates. We are thinking $40 million to $50 million of impact. Back to the Investors Conference it was more like $75 million. So just in that short period of time it changed to $30 million. All right, so all on total company sale. Josh Zable – Natexis Bleichroeder: On total company sales.

Michael A. Mussallem

Analyst · Natexis Bleichroeder

On total companies sales full year 2009. So big swings are possible Josh, but I’d say to give you an idea also that when I am looking at rates in the $30 to $35 on the euros, it probably 90 to 95 Yen. So, it actually where we are at and that’s relatively tight range but rather than give a really wild big range of I tried to say, look at relatively these rate will falling into ranges it look like that. Josh Zable – Natexis Bleichroeder: That’s all right. Very, very helpful. And then just quickly on the gross margin obviously really impressive this quarter. And I know you guys talked about expansion for next year just, can you just kind of help me walk through a little bit more granularity here as far as it is really just a mix shift to new products or a long list sort of discontinuation of products or is it just all mix shift?

Michael A. Mussallem

Analyst · Natexis Bleichroeder

Well, when we talk about product mix, we are looking at new product, new technologies, (inaudible) superior rates moving reduction, but also the discontinuation in a commodity related products so, those two together as what we are thinking about when we talk about product mix. In terms of the composition, it was pretty much and equal split in the quarter and are you more interested in the quarter Josh? Josh Zable – Natexis Bleichroeder: Quarter and outlook

Michael A. Mussallem

Analyst · Natexis Bleichroeder

Well in the quarter, it was pretty much 50-50 split in comparison to last year. But what’s underlying - what we are talking about for a number of quarters now that the rate has been improving but we were expecting some suppression as a result of FX. So as FX lightens up you are starting to see the benefit of all of these moves show up in our rates. So, we are very pleased with the rate this quarter and it’s a pretty standing in line with our expectations for next year. Next year, we actually had a chrt back at the Investors Conference and it was also about 50-50. I think it’s a 150 basis points of FX and the mid-point of the range, we gave as probably another 150 of product mix. So once again pretty even spilt.

Operator

Operator

Our next question is coming from Suraj Kalia with Sanders Morris Harris. Please state your questions Suraj Kalia – Sanders Morris Harris : Good afternoon. Mike. Gentlemen congratulations on the nice quarter.

Michael A. Mussallem

Analyst · Sanders Morris Harris

Thanks Suraj. Suraj Kalia – Sanders Morris Harris Group Inc: Mike. I am not sure this has been mentioned in the - in terms of Europe and the SAPIEN implants in Europe would you be willing to share what kind of patients are being implanted I understand the transapical two – is two-thirds?

Michael A. Mussallem

Analyst · Sanders Morris Harris

If we’re …

Michael A. Mussallem

Analyst · Sanders Morris Harris

I’m sorry what was that, Suraj. Suraj Kalia – Sanders Morris Harris: Yeah, I am sorry about that, and what kind of patients are you seeing getting implanted on an average within the transapical or transfemoral and the reason at the rationale for that…

Michael A. Mussallem

Analyst · Sanders Morris Harris

We just lost you towards the tail end. Suraj Kalia – Sanders Morris Harris : I am getting some background noise here. I’m just trying to understand whether, patients who were candidates for surgery on working candidates for surgery are getting what’s the mid-shift there?

Michael A. Mussallem

Analyst · Sanders Morris Harris

[Audio Disturbance]:

Michael A. Mussallem

Analyst · Sanders Morris Harris

Yeah, I am sorry Suraj we only get about every other word to hear somehow we are not getting the very good signal. Suraj Kalia – Sanders Morris Harris Group Inc: Hopefully, this goes through, Mike in terms of Europe what are the lessons being learned from the initial experience with the SAPIEN just to read U.S. ID, the SAPIEN, the next generation SAPIEN, what are you all seeing that are leading to either design changes and or targeted patients.

Michael A. Mussallem

Analyst · Sanders Morris Harris

Well, we’re actually, we continue to learn a lot and not to say that we’re not confident in the trial design for partner. We are very confident with that. We continue to love the ideas of people who are working as partners that surgeons and cardiologists work together. We continue to get great results, we get that we're very please to see that we're actually getting people are able to learn this procedure and learn from those have gone before them and so the fact we have a acute procedural success of 95% approximately is one that we feel very good about. People are finding the money because they are finding this to high value procedure. And so overall, there is – for a lot of learning that's taken place. Having said that we also know that cardiologist would very much prefer as - a lower profile for these transfemoral procedures and we are pretty much at the limit of size here and so our SAPIEN XT is going to be very important to make the cardiologist have an easier approach in the transfemoral vein for transfemoral artery.

Suraj Kalia - Sanders Morris Harris Group Inc

Analyst · Sanders Morris Harris

One last question Mike I’ll get back in the queue. What is the anecdotal experience from Europe in terms of not acute procedural success but let say that 30-day mortality or 12 months whatever you all have from anecdotal experience what you are seeing (Audio Disturbance).

Michael A. Mussallem

Analyst · Sanders Morris Harris

Yeah, there is some – there is some data exits that’s been reported on, that some of the recent meetings and continue to be reported on that have some 30 day results and six month results and we look forward to having some one year results during 2009 and so I say tuned or that and look forward it at the upcoming clinical meetings enthusiasm has stayed high I would say in general there are not a lot secrets out there and one of the reasons why clinician enthusiasm as high as I think their feeling is that the patients are doing well as they leave these, and so I maybe rather than me trying to general lies I’ll just leave right there, Suraj. Thank you.

Suraj Kalia - Sanders Morris Harris Group Inc

Analyst · Sanders Morris Harris

Gentlemen, thank you for taking my questions.

Operator

Operator

Our final question is coming from Kristen Stewart with Credit Suisse. Please state your question. Kristen Stewart – Credit Suisse: Hi, thanks for the follow up. Mike, I just wanted to touch base again one on the comment on additional clinical data. Is there anything specifically, we should be expecting at meeting like ACC your PCR will they update what you do some bids that PARTNER, experience or registries?

Michael A. Mussallem

Analyst · Credit Suisse

Yeah, I would say probably the next substantial amount of data, you look toward the PCR I think you would see an update on the Partner EU data I think you would see an update on the source data that we are collecting out of our commercial experience, maybe either I would imagine there will be some reports on early experience with SAPIEN XT and some live cases. So I think its going to be pretty prominent at PCR Kristine, that’s one would be a good one to get an update on that. Kristen Stewart – Credit Suisse: Do you have any updates on just kind of SAPIEN XT with respect to the U.S. trial designer you are still just kind of working through that and on I guess talking with the FDA anything with the question carrying back on the Magna Mitral Valve that was surprising and I know you reiterate your timelines, but anything out of the ordinary with some of the questions?

Michael A. Mussallem

Analyst · Credit Suisse

No, we’re not really seeing anything out of the ordinary there I mean, is there – that continues to be a tremendous amount of diligence on the part of the FDA. They focus not only on trial design but they obviously focus on the design of the products themselves and how they perform on the bench. And so I think we learned an awful a lot going through our home Micro Magna experience and going through the experience as well on SAPIEN so far and I wouldn’t say there has been a real shift over the recent past.

Kristen Stewart - Credit Suisse

Analyst · Credit Suisse

Thank you, Mike.

Michael A. Mussallem

Analyst · Credit Suisse

Okay, thanks Kristen.

Michael A. Mussallem

Analyst · Credit Suisse

All right well thanks all for your continued interest in Edward’s. Tom and David and I welcome any additional questions by telephone and with that back to you David.

David K. Erickson

Analyst · Credit Suisse

Thank 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 Relation 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, and to access this please dial 877-660-6853 or 201-612-7415. Use account number 2995 and pass code 308787. I will repeat those numbers call 877-660-6853 or 201-612-7415 the account number is 2995 and the pass code is 308787. Finally an audio replay will be archived on the investor relations section of our website. Thank you, very much.

Operator

Operator

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