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Immucor Inc. (NASDAQ:BLUD)

F4Q10 (Qtr End 27/06/10) Earnings Conference Call

July 23, 2010 08:30 am ET

Executives

Michele Howard - VP, IR

Dr. Nino De Chirico - President and CEO

Rick Flynt - CFO

Analysts

Quintin Lai - Robert W. Baird

Bill Quirk - Piper Jaffray

Daniel Owczarski - Avondale Partners

Scott Gleason - Stephens, Inc.

Kelley Roche - Jefferies & Company, Inc.

Craig Yeshion - Accipiter Capital

James Sidoti - Sidoti & Company, LLC

Operator

Good morning, ladies and gentlemen. Thank you for standing by and welcome to the Immucor Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's conference, Michele Howard, Immucor's Vice President of Investor Relations. Ms. Howard, you may begin.

Michele Howard

Good morning and thank you for joining us to discuss our fourth quarter fiscal 2010 results. Participating with me on this call are Dr. Nino De Chirico, our President and Chief Executive Officer, and Rick Flynt, our Chief Financial Officer.

Before we begin, I'd like to read the following Safe Harbor statement. Many statements on this call constitute forward-looking statements that reflect our judgment about future events and circumstances, including statements or projections about future financial results or economic performance or statements about plans and objectives for future operations.

Actual results could differ materially from these forward-looking statements. The company does not intend to update these forward-looking statements unless required to do so by the Federal Securities Laws. For a detailed discussion of factors that could cause actual results to differ from these forward-looking statements, please refer to yesterday's press release and the company's most recent SEC filings.

We'll make some brief comments and then go to Q&A. I would now like to turn the call over to Nino.

Dr. Nino De Chirico

Thank you, Michele. Good morning. I would like to start this morning by discussing NEO and the initial success we have had with this next-generation high volume instrument. As you may recall, we received CE Mark approval in February and launched the NEO at that same month in our European and distributor markets.

As you can see from our release last night, we had a strong quarter for NEO orders. All 18 orders in the fourth quarter were in our European and distributor markets. All of these orders, except for one, were competitive takeaways.

In the four months since its European launch, we have had 29 NEO orders in the European and distributor markets, which I believe is a very good start.

As we discussed last quarter, we received the FDA clearance for NEO in April and its launch in the United States is underway. We will be showing NEO at the ACC next week and have had strong customer interest. We believe NEO is more appealing to a large portion of the high volume market in Galileo, our previous high volume instrument because of new functionality such as start capabilities as well as fast turnaround time and improved reliability.

We are very encouraged by the strong start and positive customer reaction that we have had to NEO. We continue to expect to receive between 100-130 NEO orders in fiscal 2011.

The Echo continues to have good momentum. In retrospect, we were aggressive with our recorded expectations for fiscal 2010 given the economy. We also underestimated the lengthening of the sales process as we moved deeper into the market past the early adopters.

Having said that, we had a good performance in fiscal 2010 receiving 248 orders which is the same number of orders we received in fiscal 2008, the first year Echo was introduced. We had 100 Echo go live during the fourth quarter, which is a record. We have realigned the sales and the implementation team to ensure more coordination in the process of getting an instrument live.

Our new approach has required more focus from our sales team initially, but has paid off with a process that should speed the time between when an order is received and when the instrument goes live. We remain excited about the significant opportunity for Echo in the small to medium-sized hospital market as well as with integrated leader in networks that are looking to standardize their operation and implement best practices. We continue to expect to receive between 200-240 Echo orders in fiscal 2011.

Turning to our molecular offering, we announced last week that we received CE Mark approval for our HEA product, which is our largest volume product. Our HEA product performs an extended typing for 32 red blood cell antigen at the same time. We received a full CE Mark for our test for all the 32 antigens and we are the first company to achieve this for the molecular immunohematology product.

Previously we received CE Mark approval for our HPA product, which performs genotyping for platelets, as well as CE Mark approval for our current instrument.

The CE Mark for our molecular product is an important milestone for us as we work to expand our footprint in the European market. Our timing for our next-generation molecular instrument remains the same. We expect to have a research (inaudible) the instrument available in the first half of calendar 2011.

Before I turn the call over to Rick, I would like to give you a brief update on FDA. Last month FDA conducted an inspection of our facility. We had been anticipating a re-inspection by FDA as they had not been to our facility since January 2009.

At this time, we have no information to share except that we have been re-inspected. We believe the next step in the process FDA making the decision about our compliance status.

Based on our historical experience, this process could take a long time. Above all, we want to be respectable of FDA's process and therefore are limited in information we can share. We will update you on our compliance status when we are able.

As many of you know, we completed the remediation portion of our quality project in February. As we have said in the past, quality improvement is a never-ending process. We continue to work on the second phase of our quality project with the goal of creating a world class quality system. As we said last quarter, we are using internal resources for Phase II of our project and do not expect the cost to be material.

I will now turn the call over to Rick.

Rick Flynt

Thanks, Nino. I'd like to start with our instrument orders for the quarter. With Echo we received 60 orders worldwide during the quarter consisting of 50 orders in North America and 10 orders in the rest of the world including distributors.

For Galileo, we received two orders during the quarter consisting of one order in North America and one order in the rest of the world including distributors and for NEO; we received 18 orders during the quarter, all in the rest of the world markets including distributors.

On May 31, 2010 we had an instrument order backlog of 179 Echos and a combination of 43 Galileos and NEOs. Our instrument order backlog represents the total number of instrument orders that are not generating reagent revenue at the expected annualized run rate because either the instruments have not been installed or the customer validation process has not been completed.

Turning to our financials, in the fourth quarter of fiscal 2010, revenue was $82.9 million, up 5% or $3.9 million compared with the fourth quarter of fiscal 2009. Year-over-year revenue growth was attributable to price contribution of $3.4 million offset by a slight volume decline of $300,000. Currency favorably impacted revenue by $800,000.

Volume contribution in the current-year quarter was negatively impacted by a combination of factors. First, volume contribution was impacted by backordered and discontinued products in both periods. We had some products come off back order last year that's resulted in higher than usual volume for these products in the fourth quarter of fiscal 2009.

Additionally in the fourth quarter of this year, we had some products that were discontinued or on backorder which resulted in lower than usual volume for these products in the current year quarter.

So volume contribution was negatively impacted due to the activities surrounding backordered and discontinued products in both periods.

Additionally we have experienced lower volume in certain serum products from some main customers that may be sourcing those products elsewhere. Given that our strategy is to drive automation in the blood bank we believe that it's inevitable that some smaller main customers may choose alternative sourcing options.

And lastly, we are seeing volume decline in unique products that no one else supplies to the market which could indicate lower industry testing volumes and is consistent with the reports of weaker blood demand that we are hearing in the industry.

It is difficult for us to see lower industry demand in our numbers, because we are gaining customers as well as automating customers, which complicates the analysis.

Turning to gross margin. Consolidated gross margin was 72.6% in the fourth quarter of fiscal 2010 compared with 69.9% in the prior year quarter. Prior year margins included $1.8 million related to our quality project for which external spend was completed in the third quarter of fiscal 2010.

Operating income was $30.5 million or 36.7% of revenue in the current year quarter compared with $29.2 million or 36.9% of revenue in the prior year quarter. Operating expenses were higher year over year primarily due to higher research and development costs and higher G&A spending. R&D spending was higher in the current year quarter by $1.2 million primarily related to projects such as our next generation molecular instrument.

G&A expenses were higher in the current year quarter due to costs related to organizational changes including the retirement of our Chief Scientific Officer totaling $2.4 million or $0.02 per share net of tax. Our tax rate was 29.7% in the current year quarter compared with 34.3% in the fourth quarter of last year.

In the current year quarter, we recorded a one time benefit from a settlement with a state tax authority that significantly reduced our effective tax rate. Diluted earnings per share was $0.30 in the current year quarter compared with $0.27 for the same period last year.

Cash flow from operations in the current year was $84.8 million compared with $79.8 million last year. In our release last night, we reiterated our fiscal 2011 guidance. We continue to expect revenue to be in the range of $345 to $355 million, gross margins to be in the range of 70.5% to 71.5% and diluted earnings per share to be in the range of $1.23 to $1.29.

At this point, I'll give the call back to the operator to begin our Q&A.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). Our first question today comes from Quintin Lai, your line is open sir and please state your company name.

Quintin Lai - Robert W. Baird

I guess to this earning season we have heard some mixed results about the European demand and may be the impact of our certainty programs. Looking at your NEO placements, I mean you had a pretty decent NEO placement order. I mean is that just pent-up demand for the high throughput customers looking for NEO and are you seeing any impact from any certainty measures right now?

Dr. Nino De Chirico

I will start with the last point. No, we are not seeing any impact so far. The NEO demand is very encouraging I mean as I said at the beginning of my introduction, we were very pleased with the number of instrument in Europe as well as in most of these instruments except for one for the quarter were competitive takeaway, then optimistic about the NEO.

Quintin Lai - Robert W. Baird

And then with respect to the Echo, any update Nino on IDNs and their progress into – their decision cycle?

Dr. Nino De Chirico

Well the IDN model still works in the same way. Let me give you the comment I said, repeat the comment I said. We are pleased with the momentum of the Echo. Maybe we were a little aggressive in our guidance but we sold 248 instruments for the year that is exactly the same number of the first year when we launched the Echo.

What we see for the Echo is the lengthening of the sales cycle when you go deep in the market to lower volume customers, but said that, the number of Echo instrument please us.

We also want to note that the high volume instrument was better than expected. Our guidance was 70 instruments. We sold 85 instruments for the year of course, and considering that with a ratio of 3:1 in terms of revenue generating, I think we are very pleased with the high volume instruments.

Quintin Lai - Robert W. Baird

And then finally, Rick on tax rate for fiscal '11, what are you guiding toward?

Rick Flynt

Quintin we are looking at probably 35% to 36% for the full year.

Quintin Lai

And does that exclude the R&D tax credit potential?

Rick Flynt

Well, at this point it's a little uncertain. So we are incorporating that into our range and we expect it might come back but it's…

Quintin Lai

Okay.

Dr. Nino De Chirico

In our model it's exactly what Rick said is our expectation.

Operator

Our next question comes from Bill Quirk. Your line is open, and please state your company name.

Bill Quirk - Piper Jaffray

First off, congrats on the NEO side, pretty strong there. I was hoping you could give us a little incremental color here. You mentioned that obviously some of these went to distributors. Is there any way to tease out for us how much of this is anticipated stocking by your distributors as compared to actual sell-through into the customer?

Dr. Nino De Chirico

Well, the distributor model usually work that they are the instrument when they have a customer. Usually distributors do not stock instruments. They let us to do the inventory. Then we assume that all the orders we receive from distributor are for real customer, for a purchase order they really have.

Bill Quirk - Piper Jaffray

Okay. So is it safe to say Nino that something on the order of, what, 80% to 90% of those instruments were sold under distributors with the intent of placing it with…

Dr. Nino De Chirico

I think we have a 50/50 of the European, between direct sales and distributors.

Bill Quirk - Piper Jaffray

Okay. So a very small percentage of the instruments, basically then that were sold or rather the purchase orders, are going to be sitting in inventory of distributors.

Dr. Nino De Chirico

Six out of 17 were to distributors.

Bill Quirk - Piper Jaffray

And then also just in general thinking about the ongoing economic challenges and to a degree somewhat on Quintin's question, we haven't really seen much of an austerity impact on a lot of healthcare companies yet. We're seeing some in the tool side of the business, but less so from the hospital perspective.

So, given that and the likely reality that this could get tougher throughout the year, how confident are you guys on your instrument projections? And I guess in particular, thinking about Italy, given that you have historically you have had a very good business there, how should we think about all those moving parts?

Dr. Nino De Chirico

Well, like I said, we are looking at the situation. Of course we are concerned, but so far we do not see any major trend in our business, and because as always, the blood donation, the blood transfusion is the last to be impacted from these measures.

We feel comfortable with our guidance and Italy is an important business for us. But if you remember that 70% of our business or more than 70% of our business, is in North America.

In terms of economical situation for North America, we see an improvement in hospital spending, but still we don't see what it should be. We still see some depression there. And also another effect we saw lately, like Rick said at the beginning, based on some decline in sales of unique product, meaning product on Immucor sales, we perceived that there is a lower demand of blood in North America. And I believe it's another result of the economical depression.

Bill Quirk

Understood, certainly appreciate the color. One last question from me and it's just a typical housekeeping one. Can you share with us both the North American capture as well as the North American traditional numbers, please?

Dr. Nino De Chirico

Yes, North American capture (inaudible) and traditional reagent is (inaudible).

Operator

Our next question comes from Joshua Zable.

Joshua Zable

Couple of quick housekeeping items also. Just, Rick, sorry I am kind of jumping around here, but I know you talked about obviously there was extra spend related to retirement benefits, et cetera. Can you may be tease out kind of exactly how much that was? I don't know if I caught that earlier.

Rick Flynt

Yes. Josh, it actually was some changes in the organization including the retirement of Ralph Eatz, our Chief Scientific Officer. The total amount was a little over $2 million, about $2.4 million or equivalent of about $0.02 per diluted share.

Joshua Zable

Okay, very helpful. Great.

Dr. Nino De Chirico

That the restructuring costs, that one-time cost.

Joshua Zable

But that is in the continuing results, right?

Rick Flynt

It is, yes.

Joshua Zable

Okay. And then just in terms of also on the quality improvement process, you guys had 1.8 million this quarter, correct? And I was just kind of looking back through my notes and I am just kind of wondering, Nino, you made a comment that going forward you don't think there is material costs.

Maybe you can just kind of quantify that if you will to some degree, because I thought you guys had said initially $5.8 million for the year and then obviously this on top of it, the $1.8 million, by my math, I could be incorrect here…

Rick Flynt

Josh, we didn't have those expenses in the current year fourth quarter. That was a reference to prior year.

Joshua Zable

Okay, okay, very helpful. Good.

Dr. Nino De Chirico

We tried to explain the difference in gross margin. Last year we had $1.8 million, this year we did not have that.

Joshua Zable

Okay, great. Thank you. And then just on the U.S. launch of the NEO, maybe you can talk about the sort of timing relative to the expectations or how it's tracking. Obviously, I know people seem interested but just in terms of timing, when you thought you'd launch to where you think today?

Dr. Nino De Chirico

Well, as I said in my introduction, we received FDA approval in April, end of April. As we speak we are launching the instrument in the United States. We have already installed one instrument to a customer for a purchase order and it's doing well, as expected. Next week will be a big week for us because we have the New York showing at our ACC and very encouraging.

Operator

Our next question comes from Daniel Owczarski. Your line is open, and please state your company name.

Daniel Owczarski - Avondale Partners

Nino, you started touching on at a little bit about the selling environment and I was just wondering if you could give us a little bit more background. I would think that or wondering if you get more leads or at least introductory conversations these days because people, the customers are looking at reducing labor costs, or does this whole capital equipment environment or pressures on volumes even discourage people from having that conversation with you. I guess what are customers today telling you?

Dr. Nino De Chirico

Well, automation is equivalent of cost reduction, of cost savings. Then when we talk to customers we understand the pressure they are under and we try to talk to them and say that bringing automation in you can save FTEs, you can save costs. And but said that this is becoming longer, that's what I said at the beginning. It's taking longer time for us to convince a customer. Mostly because, if you look at the Echo. We are going now to a market segment where it's smaller volume.

And for them it takes more time for them, to convince them about automation. But I have no doubt that at the end of the day they will go with automation because with automation they will save money. What we see, like I said, and this is mostly a perception we received by looking at our reagents, we see less testing because there is less blood demand. And this is consistent what I have read in different reports and also what I hear from other companies in the same area.

Daniel Owczarski - Avondale Partners

Okay. And then to go back to the validation process, that NEO has been out there. There are timelines for validation. Are they different than they were for Galileo are they different for Echo? And just trying to get a little better idea of instruments in backlog, when they would go live.

Dr. Nino De Chirico

Well, first of all, let me repeat we are very pleased with the number of Echo live for the quarter. We had 100 instruments going live, it's a record. And also our days to go live reduced dramatically comparing with previous quarters. And the reason of that is because we realigned our organization and our sales organization, our technical support organization to focus on this go live issue.

The NEO we don't as yet, of course, solid data because it's too early in the process. But I believe that this change in organization will also bring benefit to go live for the NEO. The last data we have for Echo, for instance, we are below 100 days for going live. And of course, for the NEO we have to wait but we would like to see days in that kind of range.

Operator

Our next question comes from Scott Gleason. Your line is open and please state your company name.

Scott Gleason - Stephens, Inc.

I guess first, Nino, you talked a little bit about how you guys are seeing transfusion volume down with elective procedures at the hospital being down. That seems like it's a little bit of a reoccurring trend this earnings season. Can you talk a little bit about how much, from a magnitude standpoint, your guys sense is that the transfusion volumes have been down overall?

Dr. Nino De Chirico

Well, it's difficult. We don't have as such a solid number because like we said at the beginning, we have a lot of moving parts in our business model because we have competitive takeaways that really mask sometimes some loss in volume because of less demand of blood.

What I can say though it is based on information we get from the market that there is a reduction of elective surgeries. Basically, people who have to have elective surgeries that can wait, they wait, because maybe the economical situation is not helping the general population to go through elective surgery. And that's one of the cases where you have transfusion. Of course, transfusion is not impacting when you have urgency surgery because in that case you cannot wait.

Scott Gleason - Stephens, Inc.

Great. And then, Nino, if I could just maybe dwell a little bit deeper into a comment that you made on the call just talking about competition. You mentioned that from a volume standpoint that you are seeing some accounts get some of their reagents from other sources. And I guess when we think about who that other source is, is it more DiaMed/Biotest or is it other smaller players that are out there?

Dr. Nino De Chirico

Well, first of all, let me repeat what we said. Our business model rewards a customer who goes to automation or rewards customer who buys most of their supply from us. What we see, but we saw this in the past too, is that some small customer, manual customer can use alternative supplier for some serum. And that's part of the business model because the business model penalized a customer who buys a small volume or does not get to automation. Said that, I am not going to comment where this customer will go because, like I said, it's a very small volume customer. It's also a small volume for us in terms of total revenue. But of course they will go to opportunistic competitor who tried to get them on price.

Operator

Bruce Cranna, your line is open and please state your company name.

Kelley Roche - Jefferies & Company, Inc.

First of all, you mentioned the volume decrease this quarter due to the numerous factors. I was just wondering if any of that volume impacted the gross margin at all, and if that's something we can start to expect to be a recurring theme throughout fiscal '11.

Dr. Nino De Chirico

I don't know to answer the question. It can impact the gross margin because, for instance, one of the products we deleted is a Capture-Syphilis that was a product that was making around $1 million of sales for one year. And that product is not anymore in our product line and of course can impact a little bit our volume in manufacturing. But really it's immaterial because it's such a small number.

Kelley Roche - Jefferies & Company, Inc.

So looking at the traditional reagents though, it was slightly down a little bit from our estimate. Is that kind of a good run rate, I guess, for the next four quarters or so, what you guys did in the fiscal 4Q?

Rick Flynt

Do you want to answer that?

Michele Howard

Do you mean revenue?

Rick Flynt

I am sorry, Kelley, can you…?

Michele Howard

Do you mean revenue, Kelley?

Kelley Roche - Jefferies & Company, Inc.

The traditional reagent revenue this quarter.

Rick Flynt

It's going to be a moving part. We don't really give our guidance on the product line categories. But you have to remember that as we gain customers in competitive takeaway situations with our instrumentation, we have increases in traditional, but then as we convert our manual customers to automation we have decreases in traditional.

Dr. Nino De Chirico

Yes, for your models you have also to think that any time we cannibalize a customer from manual testing to automation they will move their testing to capture. Then you will see a decrease in what you call traditional but an increase in capture at the same time. In fact, capture its growing more than 20, 25%. There has an additional value you have to think when you do your model that some of the reagents are allocated on instruments, because of the way the reagent rental works, like Rick said in a previous call, some of the reagent sales are allocated to instrument sales for accounting reasons. Then it's a very complex picture.

Kelley Roche - Jefferies & Company, Inc.

Okay, thanks. And then one last follow-up. It looked like BioArray-related revenues were a little bit lighter this quarter. Could you maybe share some more details on that?

Rick Flynt

BioArray is going to be bumpy, both from a revenue standpoint as well as a gross margin standpoint, just primarily because we are at the lower volume levels yet at this point. But as we continue to grow that revenue and the product going out the door, I think it will be more stabilized, but in the short-term it's going to move around a bit.

Operator

(Operator Instructions) Our next question comes from Craig Yeshion. Your line is open. And please state your company name, sir.

Craig Yeshion - Accipiter Capital

Just wanted to ask you really quickly, you guys have done a great job of cash generation. You are now sitting on over $200 million. You also have the 2.2 million share buyback authorization in place. So any thoughts as to what you are planning in doing with that cash and any updates on where you stand with the buyback?

Dr. Nino De Chirico

Well, I will let Rick answer on the buyback. I mean, we have authorized 1.2 million.

Rick Flynt

We have remaining 2.2 million shares that are authorized for repurchase and we will look to repurchase shares opportunistically. We won't necessarily buy back shares every quarter, but we can't really say why we did or did not buy back shares. We'll also look for potentially targeted acquisitions as well as eventual expansion of our international infrastructure.

Dr. Nino De Chirico

You know buyback shares is our priority, but like we said in the past, we are not going to make a comment when and why we buy back shares.

Operator

Our next question comes from James Sidoti. Your line is open. And please state your company name sir.

James Sidoti - Sidoti & Company, LLC

A couple of questions; first, in the press release last night you noted severance expenses, and I know you already discussed the retirement of your Chief Technology Officer, but…

Dr. Nino De Chirico

It's a restructuring cost; that was one of them.

James Sidoti - Sidoti & Company, LLC

Okay. Now were those production type people or management type people, can you just give us a little color?

Dr. Nino De Chirico

I don't think we will go in that details but it was a restructuring. The way we do business and I don't know if we can go into detail, which kind of people are that.

Rick Flynt

Yes, Jim, it wasn't a layoff. We are doing some reorganization given the fact that we have the new role of a Chief Operating Officer in the company and so we are realigning some of the reporting internally. But we are not.

James Sidoti - Sidoti & Company, LLC

So you weren't…

Dr. Nino De Chirico

[Multiple Speakers] manufacturing people anyway.

James Sidoti - Sidoti & Company, LLC

Okay. You weren't scaling back because of any expected demand issues?

Dr. Nino De Chirico

Absolutely.

Rick Flynt

Not at all.

Dr. Nino De Chirico

We don't see a decrease in volume.

James Sidoti - Sidoti & Company, LLC

Okay, great. And then on the last call, or on the third quarter call, you spent a lot of time talking about shift cycles and I just wanted to know can you give us any kind of guidance going forward? Were there any particular quarters where the ship cycles would be unusually high or unusually low?

Dr. Nino De Chirico

Well, what we can say that the fourth quarter was what we call a normal quarter. It was not unusual. In the next call maybe we'll give you an update about if we see unusual. Like we said in the third quarter, that was really an unusual quarter for us; that's the reason we pointed out. It could be a combination of many factors why the third quarter was unusual but normally we have what we call a normal quarter.

Operator

Our final question today comes from Bill Quirk. Your line is open and please state your company name.

Bill Quirk - Piper Jaffray

Just two quick follow-ups, guys. First off, any update or for that matter further information requests from either the FTC or the DOJ?

Rick Flynt

We are still in the same stage with the DOJ, the subpoena phase. We have had some communications with them regarding their request but no real developments that we can share at this point.

Bill Quirk - Piper Jaffray

Okay, very good. And then second question, Rick, I know you talked a little bit about this, I was just hoping to kind of get a net number. In terms of the kind of the moving parts in the backlog clearance versus the discontinued and then the other items that went to backlog can you give us a net number for the fourth quarter?

Rick Flynt

Yes, when you look at both in combination, Bill, because last fourth quarter we had a higher than usual volumes because of products that were coming off of backorder. And then in the current year fourth quarter, we have lower than usual volumes because of the discontinued products as well as the backordered products. But the total impact on the fourth quarter is about $2 million.

Bill Quirk - Piper Jaffray

To the negative for this quarter?

Rick Flynt

That's correct.

Operator

That does conclude our Q&A section.

Dr. Nino De Chirico

Thank you very much.

Michele Howard

Thank you.

Operator

That does conclude today's conference. Thank you all for participating. You may disconnect at this time.

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Source: Immucor Inc. F4Q10 (Qtr End 31/05/10) Earnings Conference Call

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