愛德華生命科學 (EW) 2007 Q4 法說會逐字稿

Greetings, ladies and gentlemen, and welcome to the Edwards Lifesciences fourth quarter 2007 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.

Welcome, and thank you for joining us today. Just after the close of regular trading we released our fourth quarter 2007 financial results. During our call today we will focus our prepared remarks on information that complements the material included in the press release and financial schedules and then allocate the remaining time for Q&A.

Our presenters on today's call are Mike Mussallem, Chairman and CEO; Tom Abate, Chief Financial Officer and Treasurer; and Carlyn Solomon, Corporate Vice President of Critical Care.

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 2008, the regulatory approval and sales of Heart Valve Therapy products including Magna Mitral and Magna Ease, the competitive dynamics and market fundamentals of the heart valve market, the continued adoption, expected sales and product enhancements of the FloTrac system, the timing, progress and results of the PARTNER clinical trial, the market opportunity for transcatheter technologies, and the European launch and expected 2008 sales of the Edwards SAPIEN valve.

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 Annual Report on Form 10-K for the year ended December 31, 2006, and our other SEC filings which are available on our Web site at edwards .com. With that I'll turn the call over to Mike Mussallem. Mike?

Thank you, David. We are proud of what we accomplished in 2007. We aggressively prioritized investments and sharpened our strategic focus on opportunities that provide greater growth potential.

During the year, we sold the LifeStent and TMR product lines and exited a distribution products business in Japan. In addition, we acquired the CardioVations product line which complements our growing focus on minimally invasive cardiac surgery procedures.

We made significant progress in our innovative transcatheter valve program including commencing enrollment in the PARTNER pivotal trial in the U.S. and receiving CE Mark for our SAPIEN valve which is growing rapidly in Europe. In 2007, we also substantially increased our transcatheter investment to drive the long-term value of this transformational opportunity.

We also made investments to strengthen our quality and information systems for future growth and finished the year with strong momentum achieving 10% sales growth in the quarter.

Now turning to a detailed fourth quarter results, on a reported basis total sales for the quarter grew 10.3% to $293 million, and grew 9.7% on an underlying basis. Reported growth was aided by foreign exchange and negatively impacted by discontinued businesses.

Before I begin reviewing our product line sales Carlyn Solomon, our Corporate Vice President of Critical Care, will take you through the results for his business. As you can see from the numbers Critical Care had a very strong year. This business is approaching 40% of our total sales and its growth and profitability have accelerated over the last few years. Following a review of our sales results and an update on the PARTNER trial, Tom will discuss the financial results.

With that I would like to introduce Carlyn Solomon. Carlyn?

Thank you, Mike. I'm pleased to have the opportunity to discuss the Critical Care business with you. For the fourth quarter, Critical Care reported $113 million in sales, up 20% which included a $4.8 million contribution from FX. On an underlying basis fourth quarter sales grew 14.4%, the strongest quarterly growth rate of the year.

Sales of new products led by FloTrac continued to be the biggest growth driver this quarter. In the quarter, we increased share gains of our world leading pressure monitoring products. Our focus on operational excellence has led to a high quality platform with the ability to respond to demand increases for these products. In addition, a sharp uptick in year end sales of hardware products boosted our growth.

For the full year 2007, our underlying growth rate exceeded 10% and beat our original sales guidance. This represents the third year in a row of accelerating sales and improvement in gross profit margin. In addition, we are pleased to have exceeded our goal of doubling FloTrac sales for the year.

Our renewed focus on innovation in Critical Care has been a primary growth driver for the franchise. In the fourth quarter, we introduced FloTrac enhancements to the U.S. market which allow clinicians to more easily trend patient status, and, in 2008, we plan to introduce additional product enhancements that will enable FloTrac to address an even wider range of patients.

In 2007, we expanded sales of PreSep, our central venous oximetry catheter for early detection of sepsis. PreSep sales increased about $3 million, which included just one full quarter of reimbursement in the important Japanese market. Detection and treatment of sepsis remains a clinical challenge and PreSep is beginning to gain adoption.

Our haemofiltration product line grew 13% on an underlying basis for 2007 and we expect continued strong performance in 2008. Pressure monitoring had a strong fourth quarter as we continue to gain share as a result of our focus on operational excellence.

We are also benefiting from a change in clinical practice which emphasizes reducing infection risk resulting in increased sales of our closed blood sampling systems. We expect this trend to continue for the foreseeable future.

With the innovation of our new monitoring platforms we have expanded our focus to include selling hardware and service in addition to disposables. In the past year, we have seen steady growth in capital sales. The fourth quarter was particularly strong as we replaced a number of old generation hardware systems with our innovative new Vigilance II monitors.

Improving our rate of innovation, improving operational performance and changing our business model to sell hardware and service, has allowed us to have increasing growth rates over the last three years. Given our success in 2007, we believe we will achieve another strong year of strong sales and profit growth in 2008. Now I will turn the call back over to Mike.

Thank you, Carlyn. Reported sales for Heart Valve Therapy were $131 million for the fourth quarter, which included a $6.4 million contribution from foreign exchange. This represented a 9% growth rate over last year despite continued U.S. competitive pressure. For the full year 2007 growth in the U.S. was flat.

We are focused on improving our performance in this region in 2008 by introducing new products, promoting minimally invasive valve procedures and leveraging our recently expanded field sales organization. International markets led our sales growth as we continued to realize share gains from new product introductions.

In Europe, our strong double-digit sales were driven by the expanded adoption of Magna Ease and Magna Mitral, and with the launch of our SAPIEN valve in Europe transcatheter heart valves contributed over $2 million. In Japan, the recent introduction of our PERIMOUNT mitral valve helped drive double-digit sales growth, and in emerging markets we also had strong double-digit growth.

Overall we believe that the heart valve market fundamentals remain unchanged. We estimate that global market growth averages about 3% to 5% annually led mainly by unit growth. We believe that the U.S. growth was just below this range in 2007. On a global basis the market continues to be driven by mechanical to tissue conversion and new product launches.

Additionally, we believe that the launch of transcatheter valves in Europe will further stimulate market growth beginning in 2008. In Europe, we are pleased with the clinical performance of Magna Mitral and continue to believe that this is also an important valve for U.S. patients. We are currently responding to FDA questions regarding pre-clinical bench testing and continue to work closely with regulators to further the approval process. We continue to anticipate a U.S. introduction in mid-year 2008.

We are actively working to extend our Magna platform into the large U.S. aortic segment. Magna Ease, our next-generation aortic valve, builds on Magna's best-in-class hemodynamics and ThermaFix tissue treatment with enhanced ease of use. We launched Magna Ease in Europe during the second quarter of 2007 and are pleased with the level of enthusiasm it has generated.

In July 2007, we submitted our PMA supplement to the FDA and have begun discussions with the agency. We continue to anticipate a U.S. launch for Magna Ease in 2009. Additionally, in Japan we anticipate regulatory approval and reimbursement for our Magna Aortic Valve in the first quarter. We believe this market leading valve's superior patient benefits will make it the number one heart valve in Japan.

Further, we are pleased that the recently announced price adjustments in Japan are not expected to impact Edwards' valve reimbursement. Turning to Repair, our growth in this product line has been slower than normal in 2007. In the third quarter of 2008, we plan to launch our Physio II Ring which is the next-generation repair product for the degenerative segment of mitral repair.

This happens to be the largest segment in the mitral valve repair and we've experienced most of the competitive activity there. Physio II represents the first significant innovation in this area in over a decade.

Globally we are forecasting a heart valve sales growth rate of 8% to 10% in 2008 driven by several components. In our international markets where we are already competing with products that are soon to be released in the U.S. we expect double-digit growth. In consideration of competitive product launches we are forecasting a 0% to 2% growth rate in the U.S., and, lastly, transcatheter heart valve revenue is expected to contribute 4% resulting in the total growth rate of 8% to 10%.

Turning to our transcatheter heart valve platform in Europe. During the quarter, we are pleased to have received the approval for our Ascendra delivery system for the SAPIEN valve. Both our Ascendra transapical and our RetroFlex transfemoral delivery systems are currently available for sale in Europe and clinician interest is very strong.

We have broad participation in hospitals across Europe and we are continuing our disciplined launch in trained centers. We currently have 30 European centers that have placed orders and have the capability to train three to four centers per month. In addition, we continue to make progress in securing reimbursement in key European countries and are receiving support for reimbursing this innovation.

Overall, we are making great progress in Europe. Demand for the SAPIEN valve is strong with our current selling price within our expected range of 15,000 to 22,000 euros. We are increasingly confident that we will generate more than $20 million of global sales in 2008.

At last week's SDS cardiac surgeon meeting our Ascendra transapical delivery system was featured in several presentations and generated considerable enthusiasm amongst clinicians. Early transapical results were presented which established feasibility while illustrating the learning curve associated with this transformational technology in high risk patients. This data supported the inclusion of Ascendra in the PARTNER trial and should accelerate enrollment.

In cardiac surgery systems, reported sales for the quarter decreased from $22 million to $15 million due to the 2006 sale of our Brazil-based Perfusion product line and the 2007 sale of the TMR product line. Cannula sales grew to 4.3% during the quarter on an underlying basis. As you heard me say in our December investor conference, we've been reshaping this product line into a portfolio of products that complement our heart valve therapy franchise.

As surgeons think about the future they are becoming more interested in minimally invasive therapies that are very attractive to patients.

In late December, we completed our acquisition of CardioVations which includes the port access products for performing minimally invasive cardiac surgery. CardioVations is the leader in MIS procedures with 90% of their products used in valve cases. We are very excited about integrating these products into our portfolio and building upon this platform.

In the fourth quarter, we recognized nominal sales and expect to generate sales of more than $20 million in 2008.

Total reported sales of vascular products grew 19.5% this quarter and grew 17.1% on an underlying basis. The strong growth was driven by global sales of LifeStent products. For full year 2007, we achieved our goal of doubling global LifeStent sales and our high margin-based vascular business which includes our line of Fogarty clot management technologies was flat for the year.

In January, we completed the sale of the LifeStent product line consistent with our long-term strategy. I'll remind you that Edwards will continue to pursue the PMA approval and provide manufacturing services as part of the agreement. As we previously announced, we terminated our distribution of a third party line of intra-aortic balloon pumps in Japan at year end. This product line represented sales of $27 million in 2007. This decision enables our Japan operations to increase their focus on selling FloTrac and PreSep, our recently approved Critical Care products.

Now I'd like to provide an update on our transcatheter program. As announced last week, we received approval from the FDA to proceed with the revised PARTNER trial design and add our Ascendra transapical delivery system.

Having Ascendra in the trial gives cardiac surgeons an opportunity to partner in this transformational technology and most importantly it will allow us to address more parents. The recently approved trial design to consistent with what we presented at the investor conference in December.

During the quarter, we received Canadian regulatory approval to add our three Canadian sites to the PARTNER trial, including Vancouver where Dr. John Webb and his team have performed over 150 transcatheter cases. To date, we've enrolled over 130 patients in 11 centers and expect to have 15 trial sites enrolling by the end of the first quarter.

We continue to believe our progress in the U.S. gives us at least a two-year lead over the next closest competitor. In addition, at the upcoming ACC meeting in March, Dr. Webb is expected to present results on his most recent transcatheter experiences.

We continue to be pleased with our progress on the development of a next-generation transcatheter heart valve. This balloon expandable valve will have a cobalt alloy frame which gives it a lower profile without compromising the strength of the frame. Combining the new valve with the advanced delivery system will result in a four to five [French] reduction in overall profile.

The valves smaller delivery profile will make this technology available to an even wider group of patients. We continue to anticipate clinical implants of this new valve in the first half of 2008. Recently we received conditional FDA approval to start a U.S. feasibility trial of our SAPIEN valve in the pulmonic position.

While this is a modest market opportunity we are able to leverage our transcatheter valve platform and RetroFlex delivery system to address a serious unmet need in patients with congenital heart disease. We expect to start this trial in the first half of 2008.

Before I turn it over to Tom, I'm pleased to report that we have had a successful reinspection by FDA following up on our 2007 warning letter. The FDA also conducted a pre-PMA inspection for LifeStent and the few observations they noticed are being addressed. And now I'll turn the call over to Tom.

Thank you, Mike. In addition to the strong sales Mike and Carlyn already discussed I'm happy to say that our gross profit margin exceeded an all time high. Our earnings exceeded our expectations. And our free cash flow for the quarter was very strong.

Reported earnings per diluted share for the fourth quarter were $0.27 compared to $0.34 last year. Excluding special items, our fourth quarter non-GAAP EPS was $0.56 compared to $0.55 last year. Our gross profit margin continued to improve in the fourth quarter, climbing to 66% compared to 63.3% for the same period last year. This improvement was driven primarily by a more profitable product mix.

For the first quarter, our gross profit margin is expected to be slightly lower than the fourth quarter 2007 as the result of foreign exchange and our stent manufacturing agreement. For full year 2008, we continue to expect a gross profit margin improvement of 100 to 150 basis points over 2007. This improvement will build throughout the year as sales of new products will continue to grow.

For fourth quarter, SG&A expenses were $114 million, or 39% of sales, compared to $95 million last year. This increase was due to expected higher levels of spending for both SAPIEN valve launch in Europe and sales related costs in the U.S. which we announced in July 2007, as well as a significant impact from foreign exchange. For 2008, we expect quarterly SG&A dollars to remain flat at our current level.

R&D investments in the quarter were $33.5 million or 11.4% of sales, compared to $33 million last year. The increased level of spending was focused primarily on our transcatheter valve and Critical Care development efforts. For 2008, we expect R&D as a percentage of sales to be approximately 11.5%.

Net interest expense of $400,000 was unchanged on a year-over-year basis. For 2008, we expect net interest income of approximately $1 million. During the quarter, we recorded special items that resulted in a net $25.8 million pre-tax special charge.

The components were a worldwide realignment charge of $13.9 million, primarily related to our recently completed sale of the LifeStent product line; a charge of $7.1 million related to the previously announced closing of our Puerto Rico employee pension plan; a charge of $4.1 million related to an increase in our Swiss pension plan reserves; and the reversal of the prior quarter's $2.5 million gain in connection with the estimated insurance settlement from our warehouse fire in Brazil.

We will ultimately recognize this gain upon receiving the settlement.

Additionally, we recorded a $1.8 million gain on the sale of real estate development rights. For the fourth quarter, our reported tax rate was 19.4%, compared to 12.7% a year ago. Excluding special items, our fourth quarter 2007 tax rate was 25.8%. For 2008, we continue to expect our tax rate to be approximately 26%.

Foreign exchange rates positively impacted the fourth quarter sales by approximately $13 million on a year-over-year basis. Our forecast includes $36 million of benefit to 2008 sales. Free cash flow generated during the fourth quarter was $63 million which we define as cash flow from operating activities of $77 million, minus CapEx of $14 million.

For the full year, we generated free cash flow of $153 million which was at the upper end of our guidance. For 2008, we expect free cash flow to also be at the upper end of our $155 million to $165 million goal. During the fourth quarter we repurchased 475,000 shares of common stock for $23.7 million. For the full year, we repurchased a total of 2.7 million shares for $131 million.

On the balance sheet total debt at December 31 was $212 million; which included $62 million of long-term debt and $150 million of convertible debt. Net debt at the end of the quarter was $70 million. Including receivables on our asset backed securitization program, days sales outstanding for the quarter was 66 days, an improvement of seven days from the prior quarter.

Inventories decreased $6 million from the prior quarter to $153 million due largely to the exit of a distribution agreement in Japan.

Turning to guidance for Heart Valve Therapy we expect 2008 sales between $570 million to $590 million. In Critical Care we expect $430 million to $450 million. In Cardiac Surgery systems, we expect $75 million to $85 million. And in Vascular, we expect sales of $75 million to $85 million also, which includes LifeStent manufacturing sales of $20 million to $25 million.

All of these projections assume foreign currencies remain at current levels. Remember, as a result of exiting the Japan distribution agreement we will no longer have a separate sales category for other distributed product.

The first quarter 2008 we are projecting total sales of $280 million to $290 million. And, finally, as we presented in our December investors conference, earning growth in the first half of 2008 will be lower than the second half primarily as a result of our continued higher level of spending which began in mid-2007. Accordingly, we estimate that diluted EPS will be between $0.47 and $0.51for the first quarter. With that I will turn it back over to Mike.

Thanks, Tom. In summary, I believe Edwards is very well-positioned for a strong 2008 and which will be highlighted by a number of new product launches and progress on our pioneering transcatheter heart valve program.

Additionally, we are very excited to be launching our SAPIEN transcatheter heart valve in Europe and anticipate its increasing contribution to sales throughout the year. We are going to remain focused on achieving our previously stated financial goals which include generating total sales dollars between $1.16 billion and $1.21 billion, increasing our gross profit margin by 100 to 150 basis points, and generating free cash flow of $155 million to $165 million.

Finally, for full year 2008 we estimate that diluted EPS will be between $2.32 and $2.40. With that I will turn the call back over to David.

In order to allow everyone a chance to ask a question we ask that you limit your questions. If you have any additional questions please reenter the queue and we will answer as many as we can during the call. Operator, we are ready to take questions, please.

Thank you. Ladies and gentlemen, we will now be conducting the question-and-answer session. (OPERATOR INSTRUCTIONS) Our first question is coming from Rick Wise with Bear Stearns.

Hi, guys. It's James filling in for Rick. Had a quick question on guidance. Mike, I'm taking your 8% to 10% heart valve growth number for 2008, and then I apply that to your 515 that you had this year and I get somewhere in the 560 to 570 range. And I'm wondering I'm missing, or maybe I am missing something to get to you that 570 to 590 you guided for?

Yes, I don't know -- I don't know that you're missing anything, James. Again.

You are using the 8% to 10% we referred to was underlying growth rate and when you look at the dollars that includes the foreign exchange impact. Does that answer your question?

It doesn't include foreign exchange, the 8% to 10%?

Correct.

Okay. That clears it up.

So with foreign exchange it puts it more in the 10% to 15% range. If you do a straight calculation I think it's 11% to 15%.

Appreciate it. One other quick question. In 2007 you sold LifeStent. Just looking ahead at the portfolio as it exists today, just wondering if you're comfortable with the way things are positioned going forward with the PARTNER trial and SAPIEN not coming in the U.S. likely until 10 or 11, just wanted to do get your thoughts?

Yes, we are very comfortable with where we are positioned today. And as we indicated at the time of selling the LifeStent product line, what it does is give us additional flexibility of the P&L that we still have available to us for other investments that we haven't yet named.

Okay. Appreciate it.

Our next question is coming from Kristen Stewart with Credit Suisse.

Hi, good afternoon, good quarter. I just wanted to ask on the enrollment for the SAPIEN trial, the PARTNER, it looks like you were looking for around 90 by the end of the year. You are at 130 now. How are things going relative to your expectations? It seems that everything still seems to be moving on track. Any change to your expectations in terms of when these trials will likely complete enrollment particularly the [Medicorm]?

Yes, thanks, Kristen. Actually things are going the way we anticipated they would when we talked about it at the investor conference. So we continue to be right on track for what we had indicated.

So recall that our goals are to complete enrollment of cohort B by the end of 2008 and cohort A goes into Q3 2009. We are very pleased that we have the Ascendra approval which will accelerate enrollment in the trial and that one is yet to really kick in. That's just working its way through the IRBs right now.

Was that just conditional approval or was that a full-on approval to add this to the sites at this stage?

I think FDA would call it a conditional approval, but none of the conditions are really meaningful. We just have to get this through the IRBs and we will be able to start.

Okay, perfect. Thanks. I'll get back in the queue.

Thanks, Kristen.

Our next question is coming from Amit Bhalla with Citigroup. Please state your question.

Hi, thanks for taking the questions. Two quick ones, on SAPIEN in the quarter can you just give is an idea if there is any channel fill and how many procedures were done in Europe?

And then secondly on repair, can you give us an idea of what your expectations for 2008 growth rates are and maybe quantify the level of pricing pressure that the market is facing for the mature products? Thanks.

Sure. First of all you asked the questions about SAPIEN sales and channel fill. Yes, most of the sales, we said that we had more than $2 million worth of sales, most of that sales really is on the shelf, Amit. It's not like there's $2 million worth of valves that were used in the quarter.

Usage in the quarter is still relatively low and I think this will continue to be the case here early on. And as it relates to the repair market, we say typically the repair market would grow in high single digits. We would expect that to be the case. We don't feel any particular pricing pressure in this market.

We see certainly more competition, especially in this more mature degenerative segment which is why we are excited about launching Physio II which will be really the biggest innovation that will happen in the degenerative segment in probably a decade.

Okay. Thank you.

Our next question next question is coming from Larry Biegelsen with Wachovia Securities.

Hi, everyone, thanks for taking my question. Mike, I'm not sure you said how many centers in Europe are trained today and how many, and what your goal is by the end of the year?

Yes, Larry, thanks for the question. You know what, we had a lot of internal discussions on this one. Unfortunately, when you start discussing trained centers it gets to be sort of murky because there are several levels of training and even when you are done being trained that does not mean that you have necessarily have been proctored, and until you are through your number of cases I think the whole thing can be sort of confusing to the audience.

So what we've done is gone through how many centers have actually ordered. So that was the number that I gave which was 30 centers have ordered. We have more centers of that that are in some stage of training but again it gets sort of murky depending on where you draw that line. Does that make sense?

Did I hear you say there's more than 30 centers in Europe in some stage of being trained today?

Yes.

That's correct.

My second question is, Tom, maybe you can walk us through the change in the first quarter '08 guidance from $0.51 to $0.53 to $0.47 to $0.51?

Larry, I don't know that there's any change in the first quarter guidance. I think as a matter of fact what Tom presented is pretty much what we laid at the investor conference in December, if you go back to what was presented there.

Okay, then what I have is wrong, I'm sorry. I thought that what you laid out for the first quarter was $0.51 to $0.53 and what you are laying out on the call today is $0.47 to $0.51. Is that my mistake?

No, I don't think so. I think you might have interpolated that off of a bar chart, maybe.

We've never given previous guidance.

We've never given a number, Larry.

Okay, thanks, guys.

Our next question is coming from Paul Choi with Merrill Lynch. Please state your question.

Thank you. If we could go back to Critical Care for a moment and I'll give this to either Mike or Carlyn in terms of the out performance here in the quarter, are you seeing an uptick in terms of disposable consumption on the FloTrac or is it more hardware sales that was the driver in the quarter here?

Thanks for the question, Paul. This is Carlyn. We actually saw strong sales in both areas. So we did see an uptick in the hardware sales, but we saw very strong sales of FloTrac, strong sales of our pressure monitoring as we continued to take share as well there, and then our PreSep catheter also had a very good quarter. So it's kind of a good quarter all the way around.

Great. And then with respect to the haemofiltration business which also seems to have picked up a bit, and on the hardware side as well, are you seeing an increased interest in terms of capital purchases in terms of the buying cycle or would you call this a one timer?

The haemofiltration business is one that has actually slowed down a little bit in 2007 for us. We slowed down to about a 13% growth rate, still very strong. We anticipate that we'll have a very good year in 2008.

So it actually wasn't a pick up and, of course, that includes the sale of hardware and there is no significant bump up against prior years. And it also includes sales of disposables and solutions around the world. We did extend in haemofiltration some of our geographical reach this last year and continue to anticipate doing that.

Thanks. I'll jump back in queue.

Our next question is coming from Sara Michelmore with Cowen and Company. Please state your question.

Yes. Thank you. Mike, you mentioned that you were making some progress over in Europe getting some reimbursement for SAPIEN. I was wondering if you could elaborate on exactly what was going on there?

But if you could give us some specifics on what the exact progress is and while you're at it maybe comment on where the funding is coming for the initial product sales here for SAPIEN? I don't think that we or you had expected it to be a constraint in the near term, but I was wondering if you could give us a little color on where the hospitals are getting the money to by the valves? Thanks.

I would be happy to give you a little bit here, Sara, but you might find this a little disappointing because I won't give you extraordinary detail because to some extent we feel that this has competitive relevance. I can tell you we are focused in the major countries.

We've made progress in France, in Italy, in Germany and that we are able to get reimbursed in those centers. Very consistently with what we anticipated being reimbursed. And we don't -- and even though, as you correctly point out, we don't have formal reimbursement in place. We are able to work within those systems such that we will feel confident that we will be able to achieve our more than $20 million in 2008.

But it is, it is a pretty complex process as you might imagine and I think --

It's fair to say it's a combination of sources, I think in some country's it's regional. In some cases it's the hospital itself and then others it goes to the national level.

Okay. But it sound like you're happy with the progress agrees you're making?

Correct.

Secondly, as you get into this launch I know that procedural success is something that's very important for you guys to track. Can you just remind us how exactly are you tracking the procedural success here? And is there a way that you have thought about communicating that to us or updating us on the experience over in Europe? Thanks.

Yes, it's a good question, Sara. We are hyper focused on procedural success and we really look at all aspects of procedural success when we measure ourselves. Probably the easiest one that people like to go to as some sort of an indicator of what 30-day mortality looks like associated with this group.

And given that this is is a high risk group of patients you wouldn't expect them to do very well. And we like to find ourselves keeping that number at 10% or less. We find there is a learning curve that's associated with that and we work pretty hard to make sure the new centers that have come up are well down the learning curve as they start up.

I think you will see it routinely presented at upcoming surgeon meetings and cardiology meetings it's so topical. I think it's the easy way to keep track of how it's going.

Okay, thanks very much.

Sure.

Our next question is coming from Jason Mills with Canaccord Adams.

Thanks, congratulations on a good quarter. Mike, starting with Critical Care I was wondering if you could help us out with the gating of quarterly revenue for 2008.

The reason we're doing this, we start the end of the year in fourth quarter and looking forward, a year from now when you report your fourth quarter are we going to be talking about the difficult comp that is this fourth quarter, and, therefore, perhaps we should start now by modeling the fourth quarter of next year to reflect that difficult comp.

And therefore the first three quarters of the year would show growth rates significantly higher than the fourth quarter -- you see where I'm going? I'd just like to make sure that we are on the same page in the Critical Care side, I think it behooves you and us.

That's great, Jason, and let me make an introductory comment and since we've got an expert here with us I'll let Carlyn provide a little color. Yes, indeed in the fourth quarter this year we saw some things here that may not be reproducible next year, particularly this uptick in hardware sales.

As we've changed out some of our older monitors, individual and [stu] monitors, we got a pretty good bump here toward the ends of the year that may not be replicated in the end. But I'll let Carlyn comment on what we think the trend will look like during the course of '08.

Yes, so, Jason, Carlyn here, when you look at this business, we feel like we have guided to this being an 8% to 10% growth business for 2008. And you are going to see relatively flat growth rates as an underlying basis as we kind of go throughout the year with a dip in Q4. So there is some dip there.

Okay. So relatively flat meaning that that 8% to 10% range, and then dipping below that range in the fourth quarter?

In terms of growth rate, but it will be our highest sales quarter but the growth rate won't look out.

It will follow a very similar seasonality, but as you expect and we stated fourth quarter was a big number this year.

But you said relatively flat. I just didn't want anyone to think that that meant zero, right, flat growth.

Zero, no.

And then, secondly, on the Magna Mitral side, obviously a sore subject for the Company given that we've kind of been expecting this for awhile. I guess from what we are hearing, Mike, you are not the only one here that's seeing a delay when you're have an exposure to a PMA or PMA supplement vis-a-vis turnover at the FDA, and, frankly, seemingly fewer people to deal with, things at the FDA.

I guess my first question is it the same reviewer now that you had two years ago or even a year ago, if you could help us out with some of the logistical information? And also what could be the variance in potential time lines of approval, understanding you've been bitten by this question before, but are we talking about a wide variance, in other words, the question is such that you could receive approval tomorrow or third quarter, it's that wide?

Well, let's start from the top. Good questions. First of all, yes, there have been changes at the FDA. There's been several reviewers, I think, it's probably changed two or three times since the approval a couple of years ago.

So, yes, it is some new people although there are some consistencies associated with this. And I almost hesitate to get into the business of predicting FDA approvals just because it is so tough to do. I can tell what we built into our plans was a mid-year approval which gives us, would give us a bump in our sales rate and when we give a growth rate in the U.S. of 0% to 2% given the competitive nature of the U.S. market in 2008, I think it sort of takes into account that range, albeit a little earlier or later or not in the year.

Could it be a wide range? I'd have to say, yes, based on our past experience. It could be, it could be a wide range. I really find it difficult to nail this down with a great level of precision.

Fair enough. Thanks, Mike.

Our next question is coming from Glenn Reicin with Morgan Stanley.

Good evening, folks. A couple of follow-ups here. I didn't hear the actual FloTrac sales for the quarter or for the year if you can help us out there? Same thing with PreSep. You gave us the sales increase, but you didn't really give us any context as to how big that business is?

Glen, this is Carlyn. So for the year for FloTrac we did, in fact, double our sales. We said that we slightly over achieved last year the $15 million and we more than doubled that. By just a little bit. On the PreSep level we are, for the year, we are approaching, we approached $10 million in sales.

Okay. And when you say more than double, is that like more than $33 million for FloTrac?

You're right in the ballpark.

Okay. And then just trying to understand the SG&A progression for the year. It sounds to me just based on the guidance that your actual spending in SG&A in dollars will be very high in the first quarter, moderating as the year progresses and I guess on an absolute dollar basis be the highest in the fourth quarter. Is that a good way of looking at it?

No, actually then I didn't do a great job of communicating, Glenn. What I'm trying to depict is a very flat SG&A next year in terms of dollars.

So what does that mean like in the one --

What I said as a mark as fourth quarter spending. So we reported, I think, 114 this quarter, saying it should be very flat next year with that. And one of the drivers there is that the investment in Europe is going to be probably heavier.

We are getting into training and making sure that we are getting off to a heavy start there. And so then the natural growth sort of flattens out, it sort of offsets that and we end up at a relatively flat spending level throughout the year.

That just leaves to a very back half driven year in terms of EPS growth?

Exactly.

But the thing is, the thing that's interesting about it, Glenn, is its not back half driven because of some sort of sales spike, right? Actually the sales are not very different between first half and second half, it's just that the comparisons change between the step-up in spending and in the second half of '07?

The seasonality of sales is pretty much as you saw in 2007. There's also margin improvement going on, Glenn, that sort of also contributes much less than expenses, but the expenses are the biggest piece.

Okay. All right. I think I got it. Thanks.

Our next question is coming from Mike Weinstein with JPMorgan.

Thank you. Good afternoon, guys. Let me start, I just want to clarify, first, the, what you call the sharp uptick in the year end hardware product sales that helped the growth, you want us to do think of some of that as being non-recurring, Mike? Is that like $2 million to $3 million as non-recurring or how should we think about that?

Yes, I think that's reasonable to think about it that way. I would say that we always see some sort of an uptick. It seems as though hospitals sometimes use their budgets at year end to buy some hardware. It seemed like it was exaggerated this year, probably because there were a number of hospitals that were replacing their old monitors with new Vigilance II monitors. That was probably the key driver.

Okay, but I threw out $2 million to $3 million, I don't want to put words in your mouth, is that roughly the right range?

I will leave to it Carlyn here.

Yes, you are in the right neighborhood, maybe a little bit higher, but you are in the right neighborhood with that.

Mike, I'd say it is in the neighborhood of $3 million to $4 million.

Okay. That's fine. Then I want to do talk about the base valve business but just kind of did the math on your comments about currency and the SAPIEN contribution in Europe.

Your base valve business organically was growing 1.5% to 2%, that type of range, and if I do the math on your guidance for 2008 for your valve business it implies a range of growth of 2% to 6% ex-SAPIEN and ex-currency. Is that math about right, taking the base valve business growth next year organically -- this year, in '08?

What we projected for 2008 is the base valve business would grow around 4% to 6%. That's a combination of the U.S., projected to be low because of competitive activity, and outside the U.S. being at double digits. So that is, that's at a higher rate than an average [staff] for this year. But probably not very far off the fourth quarter.

And that 4% to 6% --

Without currency, Mike.

Yes, yes, 4% to 6% without currency. But if you are saying 570 to 590 you are saying north of $20 million for SAPIEN and let's say the currency benefit in the valve business is half the overall Company's currency benefit for the year, it would seem like the range is maybe just a little bit skewed or is my math wrong here?

Okay, I'm not --

We can walk through it later. But you're saying 4% to 6% growth. The key thing is your thoughts.

Underlying growth.

Underlying growth, and your thoughts on the timing of that growth first half versus second half given Magna Mitral and some of the other products?

Yes, the growth rate is going to step up and one of the drivers of it -- some of it is Mitral Magna but THV is probably even a more substantial driver of the growth rate of mitral valve. So heart valve growth rate does step up a little bit as it goes through the areas. I would say there is sequential improvement but the biggest driver is probably THV.

Last question, Mike, the, as you mentioned the increase in the competition in the U.S. valve market, what are you seeing from a pricing standpoint from these competitors, particularly, one of the newer competitors? We keep hearing reports of them being more aggressive in pricing which can be disruptive, so curious to here what you are hearing?

Yes, you know what, we haven't seen the competitors, especially the new competitors in the marketplace in a big way so I'm not sure that we can really lay out a benchmark. We also are, we hear occasional reports that the pricing could be low.

I can tell you as it relates to our pricing we are really not seeing pricing move in the U.S. It's been very consistent. And we still don't think this valve market is becoming a price game.

Got it. Great. Thank you.

Thanks.

Our next question is coming from Tim Lee with Caris & Company.

Thanks for taking the question. I know I'm splitting hairs at this point, but in terms of SAPIEN should we expect to see sales uptick here from these [low mos] rather than the draw down in inventory here in Q1 '08, how should I be thinking about that?

Yes, I think you should expect to see sequential improvement in valve sales, Tim, every quarter. And, again, because just the nature of this when a new account starts they will do some sort of a stocking order? I'm not indicating that every valve is going to get used, but definitely we are expecting sales to sequentially step up.

And I know it's still very early days, but are the implants still going into the high risk patients or are we seeing any of the average risk patients starting to get implanted with this device?

Yes, I would say we are going, our centers are going after high risk patients. We are really not steering this toward patients that otherwise are good candidates for surgery.

Okay. Thank you.

Sure.

Our next question is coming from Charles Chon with Goldman Sachs.

Thank you, just some housekeeping items. First of all, FX is a nice contributor, positive contributor during the quarter on the top line. Could you remind us again how FX flows through the P&L and would you be able to help us understand what the benefit may have been on EPS from FX during the quarter?

Sure, I'd be happy to. You know there was about 13.5, I want to say, on the top line, a little bit more than we originally expected and we do have instruments in place to hedge the downside which sometimes takes away a bit of the benefit when things go your way. But in summary I would say the bottom line is about $2 million to $2.5 million of benefit on a full year-over-year comparison.

Okay. Great. That's very helpful. And you indicated that the inspection by the FDA is now complete. Could you tell us what the next steps are going forward?

As it relates to what, Charles?

As relates to the warning letter situation that had you before?

I think, I look at that one and say that one is largely behind us. Obviously, it's a situation where you need to stay in full compliance. But the issues that were found when they originally did their inspection back in 2006 that led to a warning letter in 2007 were reviewed in great detail when they were just recently in and we got a very favorable report.

So we really look at that one as saying that chapter is behind us, although I'm sure we are going to have a lot of interaction with the FDA on many other compliance issues.

Terrific. Thanks for your help.

Thanks.

Our next question is coming from Ashim Anand with Natixis Bleichroeder.

Hi, guys. Thanks for taking my call and congratulations on a nice quarter. Obviously, the Critical Care did pretty well and you said the gross margins have improved on that segment. I was wondering if you could tell us more about it?

Overall, we have a number of products that are exceeding the corporate gross margin rate, so FloTrac does that, PreSep does that and then we have some products that are more of our legacy products that don't meet the corporate gross margin rate.

But we have seen over the years that are improvement in gross margin has equaled or outpaced the corporation's improvement in gross margin. But still today if you take everything into account we are below, Critical Care is below the corporate gross margin rate.

In going forward how should we think about this?

We continue to look at 100 to 200-basis-point improvement every year. That's the target I'm given by Mike to go after so that's what we continue to work on.

Nothing specific for the Critical Care you can tell going forward?

Do you mean specifically on a gross margin rate?

On, for Critical Care segment?

I'm sorry, I'm not sure I understood the question, Ashim.

Going forward we should expect gross margin improvements on Critical Care segment?

Yes. As a matter of fact from a broad perspective at Edwards we are continuing to indicate that we will have 100 to 150-basis-point improvement in 2008. And beyond for that matter.

We've got a broad margin improvement effort that's been yielding a lot of results, actually as this manufacturing supply agreement sunsets we are going to get a lift from that, and our new products are all operating at margins that are higher than our corporate average.

So we've got a lot of thing that are lifting us up, but I'm pleased to say Critical Care size given the size of its business when it improves its margin the way it has over the last three years or so and I think lit continue also is a contributor.

Wonderful. Thank you.

Our next question is coming from Kristen Stewart with Credit Suisse.

Hi. Thanks for taking the follow-up. Tom, the tax rate that you had suggested, I think it was 26%, does that include or exclude the R&D tax credit?

Well, you know for us, Kristen, it excludes it technically but the difference is not significant. I'd say you're down to not all that meaningful of a number.

Okay. And any update on the Singapore manufacturing where that stands and to what extent we will start to see that come on line throughout the year?

I would say that continues to go well. What we are in right now is the validation of our processes so that facility is in place. We are validating processes. We are looking forward to continuing to ramp that up over time. It's going just the way we planned it. We are very pleased with the way it's going.

Okay. You had mentioned, Mike, I think, in your prepared remarks that you did not see any push back on the price for the SAPIEN product, you're still holding around 15,000 euros to 20,000 euros, or 22,000 euros?

Yes. That's correct. Remember when we did our modeling we sort of said that we expected pricing to fall in that 15,000 euro to 22,000 euro range, where 22,000 is our list price and it's turned out just that way so far.

Okay. Great. Thank you.

Our next question is coming from Amit Bhalla with Citigroup.

Hi. Two quick follow-ups. Could you give us a quick update on Monarch and also give us an update on the next steps and time lines for the Cook and CoreValve litigation? Thanks.

Okay. Thanks, yes, first on Monarch, what we, nothing has changed since the last time we gave you an update on that which was at the investor conference which is we are doing follow-up on the approximately 60 patients that are part of the EVOLUTION I trial to get really deep into all aspects of how their valves are performing here as we watch them on a longer term basis.

I will say we will be complete with that evaluation by the third quarter of this year at which time we will make a decision either to roll into EVOLUTION II or take some other sort of strategy.

As it relates to, your other question here was about the recent announcement from Cook that they've launched litigation in Germany. On that one we have not yet seen the complaint although we have seen the patent, we continue to be very positive and confident in our IP portfolio. And I don't have an idea of what the timing would be on that.

As it relates to the litigation against CoreValve in Germany we are thinking that it's probable that there is a third quarter of 2008 action.

Thank you.

Thanks.

Our next question is coming from Glenn Reicin with Morgan Stanley.

Hey, thanks for taking my question again, I'm just looking at the last chart in your press release where you are giving us underlying growth rates and couldn't help but think what you were saying on pricing on valves. So if we look at 5.7% underlying growth for the quarter and then we take out the contribution from SAPIEN, which is about a point and a half, you have roughly 4.2%, 4.3% underlying growth. What's unit growth?

What's unit growth in that? For us or for the market?

No, for you guys.

I think unit growth is probably very similar to that number. I'd say it's very close. There's really no change in pricing that's very substantial.

Even with mix?

Well, you know what, I tell you one thing that has happened. Because we have our growth outside the U.S. where pricing is a little lower than inside the U.S., we probably have higher unit growth now that I reflect on it, Glenn. We probably have higher unit growth than that just because of the difference between pricing inside the U.S. and outside the U.S.

You used to give us Magna penetration, I assume it hasn't changed much in this past quarter?

Yes, it's pretty similar, right. Magna, you are saying as a percentage of total Edwards valve sales?

Yes.

Yes, it runs in the high 57% percent, in the aortic position, 57%, something like that, 58%.

Okay. And then you take two-thirds of that and that's total? Magna as a percentage of your total business?

Okay, what that was is Magna as a percent of our sales in the aortic position globally.

And you figure two-thirds are aortic, one-third would be mitral?

Yes but, again, you have to make the distinction between repair and replacement in the mitral side. So don't forget to do that.

Okay. Got it. Thank you.

Sure.

All right. There was one correction I wanted to do. In my opening remarks, I made a statement in regards to R&D spending in 2006 and I think I stated 33, which was the same number as '07. Instead it was actually $30 million for 2006. So in 2007 it was a $3.5 million increase in R&D spending.

All right. Well, thanks everybody for your continued interest in Edwards. Tom, David and I will welcome any additional questions by telephone. With that, back to you, David.

Thanks 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 Web site at edwards .com.

If you missed any portion of today's call a telephonic replay will be available for 72 hours. To access this please dial 877-660-6853, or 201-612-7415, and use account number 2995, and passcode 270419. I'll repeat those numbers, 877-660-6853, or 201-612-7415. The account number is 2995, passcode 270419. Finally, an audio replay will be archived on the Investor Relations section of our Web site. Thank you very much.

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