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Edwards Lifesciences Corporation (NYSE:EW)

Q2 2009 Earnings Call

July 20, 2009 5:00 pm ET

Executives

Michael Mussallem – CEO

Tom Abate – CFO

David Erickson – VP IR

Analysts

David Lewis - Morgan Stanley

Larry Biegelsen - Wells Fargo Securities

Michael Weinstein - JPMorgan

Kristen Stewart – Credit Suisse

Timothy Lee - Piper Jaffray

Jason Mills - Canaccord Adams

[Bruce Nudel] – UBS

Glenn Novarro - RBC Capital Markets

Amit Bhalla - Citi

Sara Michelmore - Cowen and Company

Joshua Zable - Natixis Bleichroeder

Spencer Nam - Summer Street Research

Keay Nakae - Collins Stewart

Joanne Wuensch - BMO Capital Markets

Operator

Greetings ladies and gentlemen, and welcome to the Edwards Lifesciences second quarter 2009 earnings conference call. (Operator instructions). It is now my pleasure to introduce your host, Mr. David Erickson, Vice President, Investor Relations. Mr. Erickson, you may begin.

David Erickson

Welcome and thank you for joining us today. Just after the close of regular trading, we released our second quarter 2009 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 Michael Mussallem, Chairman and CEO; and Thomas Abate, CFO and Treasurer.

Before I turn the call over to Michael, I would 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, expenses, net income, earnings per share, and free cash flow goals or expectations for 2009, the regulatory approval 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, expected sales and enhancements for the FloTrac system and the development of continuous blood glucose monitoring technology.

These statements speak only as of the date on which they are made and we do not undertake any obligation to update them after the date they are made. 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 differ materially 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 31st, 2008, and our other SEC filings, which are available on our website at www.edwards.com.

With that, I’ll turn the call to Michael Mussallem.

Michael Mussallem

Thank you David, we’re proud to report strong second quarter results. Total underlying sales growth was 9.8% with our heart valve therapy franchise once again making a significant contribution. In addition we continue to make important progress on our transcatheter heart valve technologies.

This quarter’s results were also highlighted by a continued step up in gross profit margin driven by the strong performance of new products and divestiture of lower margin product lines. Our product mix represents a new baseline of profitability from which we can continue to expand.

Now I’ll shift to a more detailed review of our product line sales and progress on new products and then Tom will discuss the financial results and outlook.

For the second quarter we reported heart valve therapy sales of $182 million, which includes the negative impact from foreign exchange of $10 million and a $4.1 million benefit from IMR in [deteologics] repair products return. Remember that in the fourth quarter of 2008 we excluded $4.5 million from our underlying sales for the retrieval of these products from customers because we expected to return them.

As the returns occurred this quarter we excluded the benefit from our underlying sales growth rate. On an underlying basis heart valve therapy sales increased 16.7% for the quarter led by continued adoption of transcatheter values and 10% global tissue valve growth.

Turning to our surgical valve products, on a global basis tissue and repair sales growth was 7.5% for the quarter. In the US growth stepped up to 7.6% as we gained share in both the Mitral and aortic positions. Outside the US the growth rate was similar as we also continued to gain share abroad.

Magna Mitral sales in the US continued to ramp up driving double-digit Mitral valve growth in the second quarter. In May we received FDA approval for our Magna Ease aortic valve. This valve is designed for easier implantation, and has the potential for leadership in the largest segment of the valve replacement.

Although its contribution in the quarter was minimal initial acceptance has been encouraging and we expect strong adoption. We gained share in Japan as double-digit growth of heart valves continued led by our Magna aortic valve which has become the number one selling valve in just over a year.

Now that we’ve reached the anniversary of its introduction in Japan Magna aortic’s contribution to growth will begin to diminish. During the quarter we received US approval for our newest Magna Mitral valve the Magna Mitral Ease. We’re excited about this new valve and continue to believe it will extend the Magna platform by providing improved MIS capability and ease of implantation.

We’re planning to do a limited launch in the fourth quarter. Turning to repair, underlying growth in the quarter was approximately 2% which was again negatively impacted by the temporary absence of some of our specialty rings in the US. Our Physio 2 ring which has been rolled out in both the US and Europe and adoption has been brisk as a number of customers upgraded from Physio 1.

In Japan our IMR ring is currently approved for commercial use and we now plan a launch later this year as we await reimbursement approval. With our full compliment of rings now available in the US and the acceleration of Physio 2 we expect our repair growth to increase in the second half of the year.

To summarize for 2009 we now expect our surgical heart valve therapy products to achieve underlying growth at the high end of our prior 7% to 9% range driven by share gains and new products launches in the US.

Turning to transcatheter heart valves, for the second quarter SAPIEN sales were $26.5 million driven primarily by continued adoption in Europe with modest contributions from new markets and our US clinical trial. Second quarter sales exclude transcatheter valves that were used in the SAPIEN XP prevail trial which were provided at no charge.

In Europe more than 1,000 SAPIEN valves were implanted in over 145 centers during the quarter with an acute procedural success rate that remained high and selling prices that remained stable.

Sales continue to be driven primarily by implants with over 95% of the valves sold being implanted. Globally the number of implanted valves was more than 1,200 as we continued to expand. As more centers perform cases independently we’ll have less visibility into the number of valves implanted.

As a result beginning next year we’ll no longer provide this type of implant data on these calls although clinical data will certainly continue to be presented at major medical meetings. Based on our momentum we remain on track to exceed our goal of doubling the number of transcatheter heart valve procedures compared to 2008.

We expect third quarter sales to be impacted by the normal seasonality of procedures in Europe with a rebound expected in the fourth quarter. We remain confident that full year 2009 transcatheter valve sales will exceed $100 million.

Turning to our US PARTNER trial, as we announced last quarter we completed enrollment of Cohort B, the 350 patient non-surgical arm of the trial. With regard to Cohort A, the surgical arm, at the end of the quarter we had enrolled approximately 600 of the 690 patients required and at our current pace we still expect to complete enrollment by the end of August.

Once Cohort A enrollment is complete we’ll request FDA approval for continued access for all of our existing partner sites to ensure that this technology remains available for patients.

Our RetroFlex 3 transfemoral delivery system is being rolled out across commercial sites in Europe and clinician feedback and experience has been very positive. During EuroPCR, this new delivery system was featured in a number of live cases which highlighted its ease of use benefits and greater stability of valve delivery.

In the US a number of sites have gained IRB approval to convert to RetroFlex 3 in our PARTNER trial. In May at the EuroPCR meeting we featured the first human implants of our new smaller 18 french system comprised of SAPIEN XP and NovaFlex, our next generation valve and transfemoral delivery system.

In Europe we believe the patients enrolled in our PREVAIL transfemoral study will fulfill the requirements for a CE mark approval and support a first quarter 2010 launch. We believe our SAPIEN XP with a NovaFlex delivery system better addresses the requirements of transfemoral delivery.

In the US we continue to make good progress on our pre clinical testing of SAPIEN XT and expect to submit an IDE in the third quarter which could result in an approval before year end. In our 30 patient US feasibility trial of the SAPIEN valve in the pulmonic position, we’ve added sites and enrollment is over half way complete.

At our current pace we now expect to complete enrollment in the third quarter and then transition to a larger humanitarian device exemption trial. In June the UK court found Cook’s transcatheter valve patent to be invalid and agreed with an earlier German court decision that Edwards does not infringe.

In addition during the quarter we received a positive set of rulings in the US core valve patent litigation. In the [Markman] hearing which determined the scope of the claims of the Anderson patents, the judge ruled in Edwards favor on many of the critical issues. We think this improves our overall position as we approach the jury trial which is scheduled for the first quarter of 2010.

During the next few months our transcatheter technology will be featured at several conferences including the ESC meeting in late August, TCT in September, the EACTS and European Society meeting in October. That’s the European surgery meeting.

Now turning to critical care, for the second quarter critical care reported $113 million in sales which included a $6.2 million negative impact from foreign exchange. Underlying sales growth was 2.3%. Sales of our newer products which included FloTrac, [pre sup] and [pedia sat] once again achieved strong growth for the quarter while constraints on hospital capital spending continued to impact hardware sales.

In hemofiltration during the quarter our solutions provider continued to struggle which again detracted from critical care sales growth. In June we announced an agreement to sell our hemofiltration product which will allow us to better focus on our global strategic priorities.

We expect this transaction to close in the third quarter. This product line represented approximately $50 million of sales in 2008. Turning to new products, to date FloTrac success has been primarily focused on the high risk surgical environment. Last quarter we launched a third generation algorithm for FloTrac that enhances its accuracy when used in patients with sepsis and other critical illnesses.

Feedback has been very positive. At the end of the third quarter we still expect to launch a substantial upgrade that will strengthen FloTrac’s applicability in the medical ICU enabling more patients to receive enhanced monitoring with the addition of new parameters.

In addition we remain on track to launch a new hardware platform at the end of the third quarter. This new platform will provide a simpler more intuitive informational display and ultimately consolidate all of our parameters into one platform.

With regard to our continuous glucose monitoring program, during the quarter we initiated clinical studies to validate performance. Positive data would support a regulatory approval and launch of our first generation product in Europe before year end. [Glycemic] control represents an exciting new opportunity to fill an unmet need and accelerate our longer-term critical care growth rate.

In summary we expect our new critical care product introductions to drive higher growth rates in the second half of the year. However in light of the divestiture of our hemofiltration business and continued weakness in hardware sales, we’re now lowering our prior critical care sales guidance for 2009 by $20 million and now expect annual underlying growth of 3% to 6%.

Turning to cardiac surgery systems reported sales for the quarter increased to $24 million which grew approximately 8.5% on an underlying basis. MIS grew more than 20% and our base Cannula products showed modest growth. In June new research on our port access system was presented at the Society of Heart Valve Disease meeting in Berlin.

The results of the study demonstrated that using our minimally invasive system in mitral valve surgery significantly decreased the length of stay in hospitals and ICUs and improved the outcomes when compared to conventional [inaudible]. Due to the strong interest at MIS procedures we’ll continue to invest in professional education and remain confident in achieving our full year underlying growth goal of 9% to 11%.

Total reported sales of vascular products was $16.3 million this quarter and declined due to lower sales of the divested LifeStent products. Sales of our Fogerty vascular products were relatively constant versus the prior year at approximately $13 million.

Turing to transcatheter mitral repair, enrollment in evolution two for our Monarch system has been slower than originally anticipated. We recently expanded our trial to include specialty heart failure centers in order to increase the rate of enrollment.

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

Tom Abate

Thank you Michael, in addition to the solid sales performance that Michael discussed we reported non-GAAP diluted EPS of $0.79, a 205 increase versus prior year driven primarily by continued expansion of our gross profit margin.

This EPS improvement was achieved at the same time that we increased our R&D investments by 20%. Before I go through the P&L I would like to remind you of the accounting treatment for the relaunch of IMR and DET logics brings.

Our GAAP results included approximately $4 million of sales, gross profit and pre-tax income from units that were returned to customers in the second quarter. We have excluded the favorable financial impact of these sales from our non-GAAP earnings.

For the quarter our gross profit margin was 69.6% compared to 65.5% in the same period last year. This 410 basis point improvement was due primarily to product mix and favorable FX hedge outcomes. Based on our strong performance to date, we expect our full year gross profit margin to be consistent with this quarter’s rate which is at the high end of our previous guidance.

Second quarter SG&A expenses were $128 million or 38.3% of sales, an increase of $2 million over the prior year. This increase was driven by higher spending for the SAPIEN valve program in Europe and sales and marketing expenses at heart valve therapy partially offset by foreign exchange.

For the full year 2009 we now expect SG&A as a percentage of sales to be between 38% and 39%. R&D investments in the quarter were $43 million or 12.7% of sales compared to $35 million in the prior year. This increase was primarily the result of additional investments in our transcatheter heart valve and FloTrac programs.

For the second half of the year we expect R&D as a percentage of sales to be approximately 13.5%. We recorded a special charge of $1.5 million during the quarter in connection with our pending hemofiltration divestiture. This previously announced transaction is anticipated to close in the third quarter at which time we expect to record a gain of approximately $45 million.

Additionally we will receive payments based upon the buyers achievement of future revenue objectives. These payments will be recorded as other income and are estimated to be $1.5 million per quarter through the end of 2010.

Other income of $2 million in the second quarter consisted primarily of balance sheet related foreign exchange gains. Our reported tax rate for the second quarter was 24.4%. Excluding special items this rate was 22.9% benefiting from the favorable results of our 2008 tax filing.

For the full year 2009 we continue to expect our rate to be approximately 24% excluding special items. When compared to the same quarter last year, FX rates negatively impacted second quarter sales by approximately $18 million. At current exchange rates we now anticipate approximately $30 million of negative impact on our full year 2009 sales.

This is $30 million better than last quarter’s guidance primarily as a result of our hedging strategies. This quarter we realized $0.02 of benefit to our EPS. Free cash flow generated during the second quarter was $66 million. We define this as cash flow from operating activities of $64 million, less capital spending of $17 million plus $19 million in tax payments related to previous LifeStent transaction milestones.

These milestones were classified as special items in prior period earnings. For 2009 we continue to expect free cash flow to be $160 to $170 million excluding the impact of special items. During the first quarter we repurchased 445,000 shares of common stock for approximately $28 million.

During the first six months of the year we repurchased 908,000 shares or just over $54 million. Turning to our balance sheet we ended the quarter with a net cash position of $69 million. Total cash of $183 million exceeded our total debt of $114 million. Our DSO at the end of the quarter was 69 days, an increase of one day from the prior quarter.

Inventory turns were 2.5, a slight decrease from the prior quarter. Turing to our 2009 sales guidance, we continue to project total sales to be at the upper end of our full year guidance of $1.24 million to $1.3 million, as the positive benefit from foreign exchange fluctuations offsets the negative impact from the hemofiltration sale.

For heart valve therapy we are increasing the mid point of our sales guidance by $25 million, $690 to $710 million. This excludes the $4 million favorable impact from the relaunch of repair rings. In critical care we are now lowering our sales guidance by $20 million to $435 to $455 million. In cardiac surgery systems we continue to expect sales of $90 to $100 million and in vascular we now expect sales to be at the upper end our previous guidance of $50 to $60 million.

For the third quarter of 2009 we project total sales of $305 to $325 million and we estimate that third quarter diluted EPS excluding special items will be between $0.66 and $0.70. For full year 2009 we are raising our guidance for diluted EPS excluding special items to $3.00 to $3.06.

We now expect to be at the upper end of our goal to grow diluted EPS by 15% to 19%. And with that I’ll turn it back over to Michael.

Michael Mussallem

Thanks for your patience. We’re having some technical difficulties here so we’re having to share a microphone but I think we can continue. So thanks very much Tom. Overall we had a very successful first six months and are expecting a strong second half of the year. Our underlying sales growth estimate of 10% to 12% for 2009 remains unchanged and we expect to meet or exceed all of our previously stated financial goals.

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

David Erickson

Before we open it up for questions, I’d like to encourage you to take note of several upcoming events. In September the TCT meeting will be held in San Francisco. At this meeting several clinicians will present their experiences with our transcatheter valve technologies and there will likely be updates on PARTNER EU.

In addition we plan to host an informal analyst meeting at this event so stay tuned for more details. Also in early December we will host our 2009 investor conference at our corporate headquarters in Irvine. At this event we will provide an update on our new technologies as well as our outlook for 2010.

Watch for more information about this event later in the year. We intend to end today’s call by 5:00 pm Eastern. In order to allow broad participation in the Q and A we ask that you please limit the number of questions. If you have additional questions please reenter the queue and we’ll answer as many as we can during the remainder of the hour.

We are now ready for your questions.

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of David Lewis - Morgan Stanley

David Lewis - Morgan Stanley

So quickly here on the EPS guidance, trying to understand the different variables here, can you quantify for us presumably critical care would have been a drag on earnings this year, and certainly you had that information last quarter, so can you help us understand in terms of earnings what was that drag or quantify the amount of that drag and then secondarily, if we think about your guidance or how your business is progressing throughout the year, it appears that GMs are coming in better but you’re incrementally inching up that SG&A. So can you talk to us about how long you think that trend is going to continue and where those incremental dollars are being spent.

Tom Abate

Point of clarification, when you said critical care was driving the growth rate, did you mean the hemofiltration business.

David Lewis - Morgan Stanley

Sorry, hemo depressing the growth rate.

Tom Abate

Hemo is dragging down the growth line. What actually happened is in the first half as we struggled with supply we actually were paying a penalty to our growth rate and that’s one of the reasons the rates were what they were. However in the second half we did expect to remedy that situation. It would have been a contributor to growth. Overall net net its pretty negligible, a few tenths of a percentage on the total company’s growth. But not a big story there.

GM I’m very happy with the gross profit margin. We’re at the upper end of what we were looking for this year, 68 to 70. We’re now confirming we think we’re at 69.5 in that range, very close. We’re very happy with that and I thought the rate was 38.9 this quarter if I’m not mistaken so not thinking that’s very much out of line but I think that’s consistent.

David Lewis - Morgan Stanley

You went to the higher end of GM and the higher end of SG&A so the question is is that a trend line we should expect to continue here over the next three to four quarters.

Tom Abate

I think the higher end, yes. We definitely gave guidance for the rest of the year for that and probably 38 plus staying within the range that I gave, 38 to 39, but more towards 39 is a fair observation.

David Lewis - Morgan Stanley

Just two quick comments here on valves, the first is just on transapical just given recent data we’ve seen both the EuroPCR and as well as recent valve conferences with the rise of the [sub clavian] approach as well as some of the consistent mortality issues with TA which largely are cohort driven, is your view of the market opportunity for TA has that shifted for you in the last six months or has it stayed relatively the same and just a second question on valves, you talked about going in dependant in Europe last quarter and again this quarter. I wonder if you quantify for us what percent of valves are now being independently approctured or not been proctured in Europe.

Michael Mussallem

Let me take them in reverse order, to the second question, right I think in the second quarter around 20% of the valves were conducted, were implanted by centers that were operating independently without any Edwards representative at the case. And that will continue to step up over time.

And in terms of transapical I would say our view is relatively unchanged although there continues to be a difference between transfemoral and transapical. Much of this can be explained by the fact that you have different patient groups that are being evaluated and also transapical is on a learning curve.

If you listen to the surgeons just recently at a surgeons meeting their optimism is actually rising on transapical as they like that procedure better and better. And much of what they’re doing is to contrast that to the open [inaudible] and I think compared to [inaudible] transapical potentially has some real advantages.

And so that’s why we look at that as an upside and one that will continue to be popular with surgeons over time.

Operator

Your next question comes from the line of Larry Biegelsen - Wells Fargo Securities

Larry Biegelsen - Wells Fargo Securities

First question on the recent report from the Journal of Cardiac Thoracic Surgery, on [metronics mosaic valve] which got picked up on heart.org on the early aortic stenonis, what are you hearing from surgeons on that and how does that factor into your guidance.

Michael Mussallem

You know that’s a relatively recent development so I would say at this point it really hasn’t changed how we look at our valve business and our growth rates. What we have anticipated in the past continues to be the case right now. So its really not a new one from our perspective. Its something that we had heard about anecdotally and really it’s a single center experience and so that doesn’t get fully adopted by all surgeons in terms of their thinking.

Larry Biegelsen - Wells Fargo Securities

And then on SAPIEN last year the implant number increased sequentially from the second to third quarter but obviously that was early in the launch. What would you expect the third quarter to look like this year compared to the second quarter, would it be more normal seasonality or are we still on a ramp where we could have sequential increase in implants.

Michael Mussallem

We always have seasonality at Edwards and seasonality in Europe is more pronounced than any other place around the world and its not unusual in our valve business for and I think last year and typically its maybe a 15% drop from Q2 to Q3 but given the trajectory of SAPIEN and the way its been growing we would hope to overcome most of that during Q3.

But I’d say that’s about as good an estimate that we have at this point but I’d certainly expect a strong rebound in the fourth quarter and feel very confident about the more than $100 million for full year.

Operator

Your next question comes from the line of Michael Weinstein - JPMorgan

Michael Weinstein - JPMorgan

Just a couple of transcatheter valve modeling questions, first would be it looks like the space [in the back of the envelope math] that the implants per center might have been down slightly sequentially, so do you have any thoughts on that. And really the same question on pricing, it seems like it varies a lot quarter to quarter and I’m sure that’s based on your mix of geographies. Obviously we’re trying to adjust for currency here as well which makes it messy too but do you have any thought on pricing. I know you made the comment that prices were relatively stable sequentially but does the dollar basis as well as if we adjusted for the currency effect would seem like it was down meaningfully sequentially. So any thoughts here would help.

Michael Mussallem

On pricing I would say that we watch this very carefully and its very stable within an existing center and that’s consistently been the case and so we really haven’t seen changes. Where you’ll see changes driven is the mix so if the country mix or the center mix changes, that would change at a small amount. You’d see some from currency but overall we’re just not seeing a lot of volatility in pricing.

I don’t think the implants for center is down very much, it might be tight. It maybe isn’t growing at the rate that it was but there’s not a big change there.

Michael Weinstein - JPMorgan

And then the transapical percentage is that around 70% of your mix. Yes transapical continues to be probably twice the rate of implant of transfemoral. And relative to PARTNER as we think about the tracking of the data into 2010 is the street thinking about it correctly that’s it most likely that you will analyze and announce the Cohort B data and then submit that data before we get to the Cohort A completion.

Michael Mussallem

Well that’s sort of a two part question, and I’ll answer this and then ask you to get back in line, but I think overall your assumption I think the way I hear your question is correct which is that Cohort B, we would anniversary a year from March, need some time to have those last patients come in, analyze the data.

So we would think by next summer we’d be in a position that we would have data that could be shared and we would hope that there would be some kind of substantial medical meeting at that time that we could make it public.

Operator

Your next question comes from the line of Kristen Stewart – Credit Suisse

Kristen Stewart – Credit Suisse

Just on the continued access is there any discussion to perhaps change that from a randomized approach to maybe a single arm registry in either the medical management arm or the surgical or will it remain randomized.

Michael Mussallem

Good question, we’re in talks right now with FDA on this and I really don’t have anything to report in that regard. What’s most important for us is that those patients continue to have the ability to receive treatment and we’re going to be lobbying hard for that one. But I really don’t know where they’re going to come out in terms of randomization or not.

Kristen Stewart – Credit Suisse

So the I guess goal to perhaps get a non randomized continued access.

Michael Mussallem

Yes we would love this technology to be available to as many patients as possible but again FDA has to judge that.

Kristen Stewart – Credit Suisse

When do you think the timing of the decision, I know it’s the FDA, but is that something that we could hear perhaps later this fall or—

Michael Mussallem

Yes, I would think so. Our expectation is that we will complete enrollment of Cohort A by the end of August and at that point it becomes a relatively urgent matter and so that’s why we’ve started now and we’re hopeful that FDA would make a decision such that our centers would have something to do in September because we know it’s a very sick group of people without many options.

So that would be my expectation but again I hesitate to predict what regulators might do.

Kristen Stewart – Credit Suisse

And have you quantified what the FX impact was on the SAPIEN business year to year, I imagine its not too big.

Tom Abate

I think year to year is probably not the best way to look at it because we had already known the rate changes occurred in the second half of last year. More importantly the change from Q1 until now or even guidance primarily the euro back even in December was at 135 which is pretty much the average rate we had this quarter.

So not a big impact at all there.

Kristen Stewart – Credit Suisse

I guess I’m just trying to figure out what the underlying growth would have been in SAPIEN if we held last year’s rates current.

Tom Abate

Well you would look primarily at the euro. As we said all along it was vastly euro based and I think euro year over year was about 18%.

Michael Mussallem

Yes, we’re in a good position for, we’re going to be in a good position for doubling for the year. We’re well ahead of that obviously as you might expect at this stage.

Operator

Your next question comes from the line of Timothy Lee - Piper Jaffray

Timothy Lee - Piper Jaffray

Just two questions, one on the SAPIEN side, with core valve having a [inaudible] here for a couple of months now, has the dynamics of the European market changed if it has changed at all.

Michael Mussallem

We really have not seen much change there. Its been very similar we feel like to what we’ve seen before. We know that there’s activity and obviously [Medtronic] is getting organized and may do some different things but at the customer level we really haven’t seen much of a change.

Timothy Lee - Piper Jaffray

And then just on a, switching to the balance sheet here, could you just talk about your cash position. With the sale of the hemofiltration business you’re going to see a big step up in your cash balance, what do you expect to do with this money, are we going to see a step up in your share buyback or just any other plans in general.

Tom Abate

Our cash position has been in a positive net cash position for a couple of quarters now. So it has not been a constraint on any of our plans and our priorities remain pretty much unchanged. We did three deals in the fourth quarter, not large, but a number of small things that had good valuation and we think that market continues to have opportunities for us and we’ll keep true to our strategy of looking at that first and then share repurchases probably second priority.

Timothy Lee - Piper Jaffray

Just on that share purchases, is there a quarterly run rate we should think of or are you just more opportunistic from quarter to quarter.

Tom Abate

Well if you look at the rates so far this year, its very consistent what our goal was, we said about 100 million keeping shares pretty close to even. It sort of depends on the second half on share price, but right now our intention is to more than offset option exercises and hold our rates there.

Operator

Your next question comes from the line of Jason Mills - Canaccord Adams

Jason Mills - Canaccord Adams

First on SAPIEN in the press release the guidance for SAPIEN seems to have a bit of an intricacy change to it in that you’re modeling for greater than $100 million in sales outside of the US. I’m just wondering on the margin in the back half of the year with continued access protocol and the PARTNER finishing up, what should we expect out of the United States in terms of SAPIEN sales.

Michael Mussallem

That’s a subtlety that I’m impressed that you picked up on. We weren’t trying to send any extraordinary signal there. We don’t really expect the US PARTNER trial contribution to change much between now and the rest of the year. Its been contributing maybe a million dollars a quarter so far and we’d expect it to contribute at a similar rate for the rest of the year if that’s your question.

Jason Mills - Canaccord Adams

Sticking with SAPIEN for a second, as you get towards the SAPIEN XT launch or hopeful launch in the beginning of 2010 what would be the composition of the expected build in inventory to get ready for that launch. The bottom line there in that question is will you be prepared for a full launch and to meet whatever demand you may see in your case I’m guessing hopefully strong demand as you launch that product.

Michael Mussallem

Again what you’re talking about is our launch in Europe in 2010.

Jason Mills - Canaccord Adams

Yes as you get closer, I’m guessing you’re going to be building inventory and preparing for that and so I’m just wondering the composition of that build.

Michael Mussallem

We’ll clearly be building inventory and we anticipate doing well with SAPIEN XT, we think its going to be a very popular valve and so we’re already building SAPIEN XT, we’re already building NovoFlex delivery systems to prepare for that.

Jason Mills - Canaccord Adams

Any change or update in reimbursement in Europe on the SAPIEN side and then just moving to a more macro level US sales growth while you’ve been producing good results is not contributed, I’m wondering as you launch these new products in heart valve therapy and critical care turns around a bit, what are your expectations or hopes with respect to your US growth which I think was about 3% this quarter and is obviously less than what you’re producing outside of the US, perhaps you could give us some color on your plans in the US and how that might contribute as we move forward.

Michael Mussallem

Again, we’ll take these questions, the reimbursement, not major changes in reimbursement. We continue to expect to have a major country reimbursement approved yet this year. Would expect the other major countries and maybe the bulk of countries to come on in 2010 but maybe another one in 2011. So really very consistent with our past plans.

In terms of the broad question about the US I’m not sure that I was tracking exactly what with it. Remember US surgical valves this quarter grew at 7.6%, that’s valves and repair, that total component. Actually valves have been growing even higher than that, more like 10% and so the repair has been holding us back to some extent in the US and we would expect that to rebound here in the second quarter and for us to see a higher level.

Also in critical care we have felt the hardware probably in the US as much as any region, anywhere and we would expect that just because of the introductions of FloTrac and our other new products that the critical care growth rate would probably step up, more in the 4 to 6% range in the back half of the year. So maybe that helps give you a sense for what the US will look like going forward at least in 2009.

Operator

Your next question comes from the line of [Bruce Nudel] – UBS

[Bruce Nudel] – UBS

last quarter you reported 850 units implanted in Europe I believe, what’s the comparable number this quarter and could you just go over the total number of implants this quarter.

Michael Mussallem

I know we can confuse things by giving a couple of numbers this quarter, the comparable number this quarter is more than 1,000 valves compared to the 858 last quarter. Because there are valves used outside of Europe and also used in the PARTNER trial we felt it was helpful to share generally the number of valves that were implanted around the globe and in the last quarter there were more than 1,200 valves implanted around the globe. Does that help clarify that point.

[Bruce Nudel] – UBS

Yes and I had a question about PARTNER V in the sense that is it a firm stop date like one year or can the follow-up and the reporting of the results kind of be protracted if in fact the event rate is not sufficiently high.

Michael Mussallem

Yes, I’m not the expert in this but I believe that follow-up does continue on these patients. The trial is specifically designed to analyze the one year follow-up and that will be the basis for approval. Are there scenarios in which you continue to collect data, or follow patients longer, I’m sure those scenarios would exist. But that’s sort of not plan A.

[Bruce Nudel] – UBS

And just because I’m slow, if there are more than 1,000 units and you had 850 in Europe last quarter what’s the difference, why was the step up in revenue relatively small.

Michael Mussallem

Well a couple of things, one is remember this quarter we mentioned that there we also some Prevail valves, this is the XT valves that were implanted at no charge and so and maybe that goes and speaks to the earlier question about ASP as well because there were there some valves there in the second quarter at a much higher level than in the past that might have been more than $0.50 million worth of sales that typically would have been implants that in this particular quarter was zero.

[Bruce Nudel] – UBS

And so Prevail units were approximately—

Michael Mussallem

I don’t know, my guess is its probably in the 30 to 50 range.

Operator

Your next question comes from the line of Glenn Novarro - RBC Capital Markets

Glenn Novarro - RBC Capital Markets

Just wanted to drill down a little bit more on what’s happening in your base valve business because it appears that the Ease family is going to be a bigger contributor end of this year into 2010 and yet you mentioned several times you’re taking market share so is the market share gains that you saw in the base business in 2Q, is it just better blocking and tackling. One of the competitors just spending less money in the space. I’m just wondering if you could provide a little bit more commentary as to why you’re gaining share when a lot of the new product flow is more back end weighted this year.

Michael Mussallem

It’s a good question, thanks. There’s a couple of things going on there. You know because of Mitral Magna we’re just having share gain in that position, but something else also seems to happen when we have a new valve like that. You get almost a halo effect in the aortic position and maybe its because our people are in there and they’re spending a lot of time with their clinicians but we also saw aortic volumes step up even in the absence of Magna Ease.

That just came at the end of the quarter and really had negligible impact on this quarter although we think its going to be substantial in the future. And I’m sure our own team would say that they’re executing at a higher level in the field as well, but I think those are the key factors.

And so I end up being very optimistic about growth rate for surgical heart valves in the US going forward.

Operator

Your next question comes from the line of Amit Bhalla - Citi

Amit Bhalla - Citi

I wanted to ask you a quick question on SAPIEN, you are moving to smaller centers that are implanting valves now, can you give us a sense of how long its taking for these centers to ramp up versus the centers you had last year and I know you answered the question earlier about the competitive change with Medtronic by saying there hasn’t been much of a competitive change, is that also the case at these smaller centers.

Michael Mussallem

I’m not sure exactly if I can be as precise as you’d like, but let me take a shot. I think we continue to add centers probably at a similar rate that we’ve been, maybe in the 20 to 25 a quarter. My sense, I don’t know that there’s been any change in terms of the way a center ramps up. The training process is very similar to what we had last year and we think its quite effective and I think people come up nicely.

And I’m still not convinced that its an intense competitive battle for share at this point. Most of the centers that are added are truly new centers that have not been involved in transcatheter [inaudible].

Amit Bhalla - Citi

And on SAPIEN XT, you said you are going to file an IDE in the third quarter so can you tell us in terms of primary end point, are you going with, is there a [mace] primary end point or it is mortality the primary end point and my additional question is litigation can you give us an update in Germany on the core valve patent validity case there.

Michael Mussallem

So the question as it relates to XT were you asking about Europe or the US.

Amit Bhalla - Citi

US IDE.

Michael Mussallem

Yes, the US IDE is one that, it still remains to be seen exactly what that trial is going to look like. We’re making a submission here in the third quarter. We continue to make good progress and we’re hoping and again this one we’re not certain of but we’re hoping that we can get an approved trial before year end. But we still don’t know what that trial design is going to look like. That’s an unknown.

On the litigation front, this is I assume what you’re talking about is the Anderson patent validity in Germany, this is the appeal of the, no this is the first time the validity will be heard. I don’t know that there’s any date set at this point. We think its going to be sometime in 2010.

Amit Bhalla - Citi

Wasn’t that supposed to be, there was supposed to be a decision the second half of this year, so is it moving out to 2010.

Michael Mussallem

No I’m sorry if we misled you on that one, my belief is that its always been 2010.

Operator

Your next question comes from the line of Sara Michelmore - Cowen and Company

Sara Michelmore - Cowen and Company

You know I was hoping you could just talk a little bit about divestiture activity and with the hemofiltration divestiture almost behind you here, what’s the outlook going forward for that type of activity. Do you feel like you’ve pruned away most of the low margin businesses at this point or should we be expecting anything else in the future.

Michael Mussallem

We feel like we by and large are very happy with our portfolio. We really have pruned away those things that are less strategic for Edwards. The things that we’re engaged in today like all of our heart valve businesses, all of our critical care business, the way cardiac surgery is related to our valve business, this is all highly strategic for the company and so we don’t have any current plans for divestiture.

Sara Michelmore - Cowen and Company

In terms of acquisitions, are you actively looking for tuck ins or is that an opportunity for you to take advantage of some of the things that have come up in terms of properties that may be out there.

Michael Mussallem

We’re fortunate enough to have a strong balance sheet and be in a position to be able to add things to the portfolio that make sense. I’m not trying to single anything that’s very large in size or scope but we continue to be very interested in things that complement our strategy, things related to structural heart disease particularly valves, things that are related to critical care monitoring that can be really [growthy].

Most of what we look at are the really, the new opportunities, the exciting technologies that change the way the patients are monitored or the way that patients are actually treated and so they tend to be more technology related things we look at and we do that very aggressively.

But as you know we’re disciplined and so we only pull the trigger on those things that we really care about.

Sara Michelmore - Cowen and Company

Can I ask you a question on the hospital glucose monitoring product, I was under the impression that the first version of that product anyways would be a stand alone. I’m just wondering if you can talk a little bit about that product and what’s the timeline on an integrated product or version of that product.

Michael Mussallem

The product that we would introduce first clearly is stand alone and matter of fact that will be a first generation product and again this is all dependent on us having some very successful clinical trials here over the next quarter or so. We’d have a next generation stand alone that’s probably behind it but then more to a more integrated system and that’s going to come later on. That’s probably 12 to 18 months down the road where we would start integrating into our current package.

Operator

Your next question comes from the line of Joshua Zable - Natixis Bleichroeder

Joshua Zable - Natixis Bleichroeder

Congrats here, a couple of quick ones, but first I know there’s a lot of moving parts, I know you kind of went over this, you took the bottom line guidance up, is that effectively just a positive mix shift here on the gross margin that’s benefiting the bottom line with all the stuff moving around.

Tom Abate

I’d say if you tried to single out the major contributor, that would be the case and as you saw in the second quarter and for the year its pretty much by the beat in the quarter that’s moving the year mostly.

Joshua Zable - Natixis Bleichroeder

And then just in terms of RetroFlex 3, I know obviously you launched that you said you had some early sort of positive feedback, I know the kind of two issues if you want to call them that with the delivery system has been related to the [nosecone] and the size, RetroFlex 3 seems to have solved that taper nosecone issue. I’m just wondering if you can comment on your market share in transfemoral right now as you view it. Obviously XT is going to be a big step to getting real, real competitive in that arena, but maybe you can talk us through where RetroFlex 3 puts you where you think you can get to until XT or if its just sort of a whether that’s going to get you new accounts, or its really just a better device for the people that are already using yours and the real competitive push comes when XT comes.

Michael Mussallem

First of all we’re very pleased with RetroFlex 3. What it really does is simplify delivery and it gives us greater stability as well when we actually deliver that valve. What we could say is when we give our projection of more than $100 million for this year, that’s based on what we have today meaning the SAPIEN valve and the RetroFlex 3 delivery system.

We think it’s a step up with SAPIEN XT obviously and gives us the opportunity to start assessing these transfemoral patients that we haven’t had the French size that’s been, that’s most popular with cardiologists.

Joshua Zable - Natixis Bleichroeder

I guess I’m just trying to gauge a little bit more expectations, obviously RetroFlex 3 is a step up but if I guess how close that moves you or the XT is really the big step up. I guess I’m just trying to figure out, I know your expectations, if there’s anything—

Michael Mussallem

I think if you were to, just to answer it more directly I think if you were to ask cardiologists, they’d be although they’d be pleased with RetroFlex 3, they’d be very excited about XT. The XT, when you take four to five french sizes out that’s a bigger deal.

Operator

Your next question comes from the line of Spencer Nam - Summer Street Research

Spencer Nam - Summer Street Research

I just have one question, I have been hearing that you were planning to split the FDA approval process based on Cohort A and Cohort B, is that going to happen here or where are you in terms of planning stage of that.

Michael Mussallem

That is our strategy. There was a, there might have been a question at one time, but since Cohort B completed enrollment in March and Cohort A we don’t expect until the end of August, there is a clear difference in timing and it incents us to move forward with Cohort B and we’re fortunate because its powered to be statistically significant as a stand alone Cohort, we have every incentive to try and do that and bring this technology to patients earlier then we would have if we wait for the full trial.

Spencer Nam - Summer Street Research

It sounds to me like you are feeling pretty confident about the overall trial and the expected outcome, can we make that kind of inference at this point.

Michael Mussallem

Yes, we are feeling good about the trials. Because its ground breaking and there hasn’t been a trial done exactly like this in the past, its tough to always predict the outcome and we know that this group of patients is a group of patients that hasn’t been studied in the past but one of the things we’re pleased at is that the SAPIEN results themselves as you can see in Europe have been even better than we might have thought in the beginning.

But having said that we like you have no visibility to the data and so we’re operating based on the kind of things that we see in Europe.

Operator

Your next question comes from the line of Keay Nakae - Collins Stewart

Keay Nakae - Collins Stewart

With respect to your IDE filing for SAPIEN XT, given the timing of that and not knowing the answer to PARTNER, does this relegate you to performing a similar type of two patient Cohort study surgical and non-surgical patients or are you hopeful for something simpler.

Michael Mussallem

I think maybe both is true. Are we hopeful for something simpler, yes we would be hopeful for something simpler and obviously randomization is not something that’s attractive to physicians or patients but having said that, with all the unknowns, if I were modeling I would say the conservative thing to do is to assume you have something that looks like the PARTNER trial.

Operator

Your next question comes from the line of Joanne Wuensch - BMO Capital Markets

Joanne Wuensch - BMO Capital Markets

A big picture one, if you can comment on anything you’re seeing in Washington, DC and how it may effect the medical device industry and/or Edwards.

Michael Mussallem

There is a lot going on there isn’t there, and obviously because of my role as Chairman of [Avamed] I stay pretty close to this. We’re concerned about it. When you hear about substantial changes to the delivery system its one that we watch carefully because we’re hopeful that there’s going to be informed policy. We know that medical technology does a lot of positive things for the overall industry but being able to fund this expansion of healthcare is calling for a lot of savings to come out of the system.

And when hospitals have to save the kind of money that is being projected it’s the kind of thing that’s somewhat worrisome for our industry. So we’re staying very close. We’re highly engaged. I don’t expect any sort of policy changes to effect the world over night. I think anything that happened would be relatively gradual but its one that very much can have impact on the long range future for our industry.

Joanne Wuensch - BMO Capital Markets

And slightly closer to home, sales presence in Europe particularly with transcatheter heart valves, how has that changed in the last six months as the adoption of the product has increased.

Michael Mussallem

I might finish the earlier question as well, I think you also asked about impact on Edwards, I feel even a little better about the impact on Edwards. Unfortunately is in a position where it makes products that are vital for patients and we expect those that that continue to be the case in the long run and maybe to have less, be less impacted by those, then those products that are more discretionary in nature.

In terms of the sales resources in Europe, those have increased. If you go back to 2008 we had almost exclusively clinical resources in Europe, clinical specialists that supported the cases and we began adding true business and sales leaders late last year and early this year and we’ve been gradually adding and we’ve been adding each quarter so its substantially larger today then it was in 2008.

It will probably continue to add a little more until we reach 2010.

Thanks very much for your continued interest in Edwards. Tom and David and I welcome any additional questions by telephone and with that I’ll turn it back to you David.

David Erickson

Thank you for joining us on today’s call. Reconciliations between GAAP and non-GAAP numbers mentioned during this call which include underlying growth rates 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 www.edwards.com.

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Source: Edwards Lifesciences Corporation Q2 2009 (Qtr End 06/30/09) Earnings Call Transcript
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