Merit Medical Systems, Inc. (MMSI) Q2 2012 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by and welcome to the MMSI Second Quarter 2012 Earnings Conference Call. [Operator Instructions] And I would now like to turn the conference over to Fred Lampropoulos, Chairman and Chief Executive Officer. Please go ahead, sir.

Good afternoon, ladies and gentlemen. We are delighted to be with you. We are broadcasting from Salt Lake City with members of our staff assembled here in our conference room. We appreciate you taking the time to visit with us this afternoon. We’re excited to report the results of our second quarter. First of all, I will ask Rashelle Perry, our Chief Legal Officer, to read our safe harbor provisions. Rashelle?

Thank you, Fred. In the course of our discussion today, reference may be made to projections, anticipated events, or other information which is not purely historical. Please be aware that statements made in this call may be considered forward-looking statements. We caution you that all forward-looking statements involve risks, unanticipated events, uncertainties, and other factors that could cause our actual results to differ materially from those anticipated in such statements. Many of these risks are discussed in our annual report on Form 10-K and other reports with SEC which are also available on our website. To the extent any forward-looking statements are made in this call, such statements are made only as of today’s date, and we do not assume any obligation to update such statements. Although Merit's financial statements are prepared in accordance with accounting principles generally accepted in the United States, Merit’s management believes that certain non-GAAP financial measures provide investors with useful information regarding the underlying business trends and performance on Merit’s ongoing operations and can be useful for period over period comparison. The table included in our quarterly earnings release which will be discussed on this call sets forth supplemental financial data and corresponding reconciliations to GAAP financial statement. Investors should consider these non-GAAP measures in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP. These non-GAAP financial measures exclude some but not all items that affect net income. Additionally, these calculations may not be comparable with similarly title measures of other companies.

Thanks, Rashelle. You sure you got it all? All right. Thank you very much. Rashelle’s new book safe harbor will be on book shelves shortly and it makes for very interesting reading. Thanks, Rashelle. Appreciate it. Ladies and gentlemen, again we appreciate you being with us today as we report our second-quarter. Let me go through some of the highlights of the quarter. As you can all see, the company grew at 10%, which is right about just flat out in the middle of our overall guidance for the year which is 9% to 11%. And I think that you would all agree that in light of many of the reports that have been out today and throughout the week, that this is, we think, a very, very good performance. I won’t go -- and I certainly don’t mean to be and to discredit anybody else, but I think this is a terrific number. One of the things I’d like to remind everybody is that Merit has, I think, a very unique business in that we have a substantial international sales effort. We also have a very nice hedge in place, because even though the euro has been lower, which means it cost us about $1 million in revenues for the quarter. We also have the other side of that and that is the hedge that we have because we have lower costs associated with our sales force and our production that we have in Ireland. So all in all, it's a very -- I think set up very, very nicely in terms of that opportunity. There were number of financial issues in terms of gross margins and a couple of other one-time expenses we would like to explain. So Kent, I am going to ask you if you would keeping in mind as we go through the numbers here, that we have some sequential improvements in operating profit that shares were up because of our offering last year and some of those issues. So Kent, I’d like you to go through and kind of go through those financial numbers for us just a second. Kent?

So our net income for non-GAAP which is what I think they are most interesting is with a record $8.9 million or $0.21 a share. I wanted to remind shareholders that our outstanding shares for the quarter were up 13% due to an offering and some options exercised last year. So we were 8.9 compared to 7.9 a year ago or $0.21 a share. Also for the 6 months, we were at a record $16.1 million or $0.38 a share, up over $15.8 million last year for -- at that because of the share difference that was $0.43 a share last year. When we get into some of the GAAP numbers, as you are aware were $6.1 million or $0.14 a share compared to $6.9 million or $0.18 a share. And for the 6 months was $11.8 million or $0.28 share compared to $13.5 million or $0.37 a share. As we look at some of the major factors underneath that the gross margins was -- I would like to address first. On a GAAP basis, they were 46.8%, up 20 bps from a year ago, 46.6%, and as for the 6 months they were 46.5%, or up 30 bps from 46.2% from the first 6 months of '11. But when we look at it on a non-GAAP basis, the second quarter was 47.8% of sales and that was up 40 bips from last year's 47.4%. And sequentially as we look at progress during the year, in the first quarter it was 47.2, so we can see a 60 bps improvement in gross margins as we move through the year from first to second quarter this year. Going down to the SG&A costs, they were 30.1% of sales for this year in the second-quarter compared to 28.7 last year, so we saw an increase as well for the year to date 30.5% of sales compared to 28.5%. When we take out particularly some costs that were due to the transactions with OsteoPro and our amortizations of intangibles, we have a non-GAAP SG&A that is 28.6% of sales. And it’s 80 bps above last year's 27.8%. But it’s down sequentially, again I want to point out. So it went down from the 29.7% adjusted on non-GAAP basis last quarter -- or the first quarter. So we improved it 110 basis points, and I think that’s significant because when you add that to a 10 point improvement in R&D, when you look at it on a non-GAAP basis, our operating income was up 180 bps. So we went from 12.6% operating non-GAAP basis compared to 11.8% in the first quarter. I think we’ve made significant progress in some of those costs. Inventories were only up $1.1 million which for the 6-month period is slowed a lot and we’ve seen that improve a lot in our cash flow from operations which were up $14 million or so this quarter and $21 million for the year to date.

Thanks, Kent. Let me go over some other highlights of where our growth is coming from him. I allude to the fact that in our comments that we had a sales gain in all divisions. The leader is China and many of you recall that last year we grew that business by almost 100% for the quarter. We were up 53.4%, 6 months we’re up almost 43% over last year. China continues to be a very exciting place for us. Our international dealers -- and this is central South America area is also up very strong, and if we look at that our international worldwide dealers is up 27% and up 31% for the 6 months. We take a look at Endotek which is our endoscopy division and that’s up 31.6% for the 3-month period as well. So OEM was up 15% and we had a substantial improvement in domestic sales. As you recall our first quarter was a pretty quiet at 2.5%, but we grew at 4.4% in the second-quarter. Our technology companies MCTech grew at 14%. And so if you just look at our business overall, our international business clearly is driving at our technologies companies and we have an improving environment in the domestic market. We’ve also received clearance on a couple of new products that I think will be of significance in the future. The Concierge guiding catheter we received a U.S. clearance. We've never had a guiding catheter in the United States. We have been selling it in some of the international markets and so we are excited about this. Recently just in the last week or so, we received clearance for our ReSolve Biliary Drainage Catheter and the reason that’s significant is we have been somewhat at a disadvantage in our drainage products in that we didn't have the full basket. And this way now we have the full capability, which drives lots of different products. So there will be a lot of pull-through in the future on this product. We also filed a 510(k) for a new snare product. One of the things that’s I think very interesting about our snares is I believe and I think is that our snare product is up -- let's see here up about 14.5% for the year. And that's pretty significant overall, particularly in this marketplace. We believe that as we add this new product called One Snare that it’s going to allow us to have substantial increases in market share at high gross margins. This product is produced in Ireland. It is sitting on the shelf, we’re awaiting approval from the FDA. We will launch just it in just I think a few weeks or so or month in the EU. So this is another exciting opportunity for us and we expect -- and my expectation is that as we're sitting here a year or a year and half from now that Merit is going to be the clear market leader and have a number of advantages. And this will play out as we go along and we'll give you more details as this plays out. But it’s a great opportunity for Merit. Now regarding the Laureate, we have submitted the requested a new 510(k) to the FDA, we’re about halfway into the cycle. And fortunately for us is that in our international markets, including China, it has taken up the slack or it’s kind of now reached the level that we had before we had to pull it off the U.S. market. And so we are excited about the opportunity that will exist when that product comes on the market as well as 4 or 5 new hydrophilic guide wires that will follow shortly through the regulatory cycle. So things will line up in terms of new products and opportunities for the company going forward. Let’s see. I want to go to -- for a minute these one-time expenses. We did a deal about 6 months ago regarding a guide -- excuse me a crossing support catheter. And this is a required payment and of course, it’s a one-time expense and that was paid during the quarter. Another technology that I alluded to, that I am very excited about -- Merit has signed an exclusive agreement for 10 years in certain nanotechnology that allows us to work with various grafts, opportunities in grafts and opportunities in covered stents. We think this is an extraordinary technology. It's exclusive to Merit and you'll be hearing a lot about this as we move forward. But even though we have that 10 year agreement, the accounting rules require that we take the one-time expense. But it’s part of our overall strategy as we can continue to move from accessory products to primary use products. It’s a long haul but as you look at Merit with micro-catheters, with snares, with embolics, with other projects that we have in the wind, these things are all higher margin -- in the event these things roll out, that allows us to meet our intermediate term goal of 50% gross margin and then move even higher than that as that mix plays out in the future. So we're excited about that opportunity. And then finally, we will be operational, fully operational with a new technology company in Ireland in our new facility. Now these are hypo-tubes, these are devices and platforms that are used for all balloons, or wires that are used to measure pressure, we’re already in the business. But much of that has been farmed out to others, and we will have a full capability to produce all these products in-house in our Irish facility. And we will be online sometime in the first quarter. So this is another exciting and in some ways a little bit of a diversification. We’ve felt and I've expressed many times to you that we have I think a unique business in that we have direct hospitals sales. But we also have an OEM business, which helps to offset other costs and to create sales and candidly higher gross margins than our corporate average. And then we have the technology companies, which is coatings and our sensor company, and we believe that having this triad of different products and then the different divisions within the medical device area being endoscopy, radiology and cardiology that it helps to spread our business in areas that have been very healthy and where other companies would like to source capabilities from us that don’t compete with our direct sales force. So that will start to play out, be more reinforced going forward into the future and something that we are -- that we look forward to executing on and reporting back to you. And then last but not least are the issues regarding our high-quality study. As many of you know we had some problems sourcing doxorubicin, there's been a shortage. We have solved that problem, and we expect that, that study will move on. There are patients that are enrolled, there are hospitals, essentially all have passed through the IRB process, and now it’s really the training and getting their study moving forward. And then we also talked about an IDE that we have filed and we expect to have response shortly from the FDA regarding PAE or prostate artery embolization for BPH. We think this is a topic of a lot of discussion. We have filed for that study and if like many of our products like the USFE procedures, allows not only this large potential market, but the use of not only the embolics but all the procedure parts of the business, the catheters and so on and so forth. And so all in all, we feel very, very good about our business. Again, I would caution that we are always as exciting as this as we are heading into the summer quarter. You never quite know what happens, you’ve got people going on vacation in Europe and you’ve got the Olympics and you’ve got this, and you’ve got that. So although we are not changing what our goals are for the year, we just like to caution everybody every year that we are heading into what generally for medical device companies it’s kind of a slower part of the year, and it starts to accelerate in the fourth quarter. I think all in all if you take a look at the groups product, you see the catheter sales are strong. You see that standalone devices are doing fine. Endotek, we talked about that, the business is doing fine. All medical devices are going to have some challenges as we move into next year with various pronouncements under the various healthcare laws. But at the same time, whenever you see those kinds of situations, you also see great opportunities that present themselves and I think Merit is positioned with a healthy business, a worldwide business. I had someone say to me, if I can bang the drum just for a moment, how much they appreciate the fact that we were wise to look at this international piece. I was talking yesterday with our new manager of a Gulf states and he was expressing to me all of the opportunities that exist in the Emirates and Saudi Arabia, in Qatar and many of the Gulf states, and we have boots on the ground. We have the regulatory approvals and we have manufacturing capabilities as well as distribution right there. So we're excited and continue to be excited about the company, about the opportunities. There are other opportunities out there as we continue to talk and we continue to see many opportunities that we look at them and see if we can find the ones that would fit. And particularly if we take a look at our embolics and take a look at the BioSphere business and again if we look at that for the year, we’re up 11%. And that's a business I am excited about it. So I think that covers it. Good quarter, I want to express my appreciation to the staff. And I think we will go ahead and turn the time over now to our operator and go ahead and answer questions to the best of our ability.

[Operator Instructions] And our first question comes from the line of Larry Solow with CJS Securities.

This is actually [indiscernible] backing Larry Solow, CJS Securities. I guess my question is a little more longer term. You’ve obviously highlighted your revenue growth and have for years, you have done a great job focusing on R&D and new products. Last year, you built up your sales force and international distribution capabilities. You’ve incurred a lot of expense. When will we see the operating leverage that’s embedded in this? You mentioned 100 points this quarter sequentially. But you’ve made massive investments in growing the company, at what point do these new salespeople and distribution capabilities leverage to much higher returns?

Well, this is probably -- might be the toughest question of the day in that the opportunities come up we’ve seen again what's happened in China. We are going through for instance in Brazil and India, in the Gulf states, in Russia and Eastern Europe, and those resources are on the ground. We hired the MS sales and more of the technical folks and clinical folks last year. And we've hired some more direct sales people in the United States because some of the territories were too big. There will be a -- in terms of a percentage, I don’t know that I want to use that. But I will say that we are substantially not going to reduce, but we’re not going to spent whole lot more money. I won’t say that we are going to hire more people because we are, but we don't have these massive expansion programs on the burner other than the ones that we've talked to you about. Now that will take time. We talked about China today. We went from -- up to 10, I think that’s just in 5 years and then it took us one to go to 20. And this year we may get as high as 30. I think the forecast is 20, but it looks like 30 or better. But they don’t all go smoothly. But the people are on the ground, and we do not have the propensity to spend more until they start to pay off. Then we have this huge bolus of these new products. Some of these lines that are now being filled out. So I think it's time for Merit to digest. And particularly I think there's another thing that makes us somewhat caution -- a cautionary in terms of these additional marketing expenses and that is you’ve got this tax that’s going to come in place next year. Our preliminary estimate is that’s going to cost us $4 million, $4.5 million or some number that we’re still trying to work out. But we recognize that, that headwind is out there and we want to kind of -- I think the point you're trying to make, and maybe the question if I can put words in mouth is, are you going to kind of slow it down and work on getting those returns and the answer is yes. It’s time to do that. So we are in that mode of thinking.

Let me perhaps ask it more specifically. Your spending on SG&A and R&D are 35% of revenues now. 18 months from now what do you see that number be?

I actually hope it will be less as a percentage of sales. We want -- if we are going to get operating leverage it has to be.

When we will get some more -- kind of add to that the gross margins improve, you can get operating margin leverage even without increasing that percentage. If we can decline or reduce that as a percentage of sales which we’ve seen sequentially as you mentioned, then that will even enhance that and improve. So you see we got some, if you look at our non-GAAP basis we had a 10% top line growth rate but we had a 13% bottom line on a non-GAAP basis.

But I think your observation is there more operating leverage opportunity and the answer of course there is, it will be up to us to make sure that we manage that. And still try to balance. But if there is a criticism of this company, you can't, I don't think you can criticize the top line. We delivered on the gross margin although there is more room there, and we can do better there and we will do better. One thing just to remind everybody, we have couple of million dollars in costs coming out next year because of our stent manufacturing and that’s 50 basis points into next year's numbers. But the real issue is this -- this SG&A side, that's where the criticism comes, that’s what you're asking. And that's what's going to help us to make more money and that’s what’s going to help our stock to move higher. We know that. So -

My second question is very specific one related to R&D expense. You probably have been slowing down some of your expense, because of the shortage of the cancer drug doxorubicin and now that, that’s back, should we assume your R&D expense will also go back up?

Yes, we said we were going to spend somewhere around -- I think it was $1 million the first year, $3 million and then maybe 2 or some number like that. And the answer is as that study starts to progress down the road that we’re going to spend more money on that study, which will be then -- is then classified into the R&D. So when I make my comments I am taking some of that out, because of that study. Now there's another side to that. And that is that those studies we just got approval in South Korea, we’re seeing and have other opportunities in China, which is the largest market in the world. We are seeing sales dramatically improved -- increase in a number of areas throughout for the product with very, very good high gross margins. So there's 2 sides to this and we believe and I believe that it will more than offset that in gross margin and sales and profits and margins so that -- that topside is that Kent is talking about. And your question is, the expense is there, we still believe it's the right thing to do and let's talk about the outcome. At the end of the day when it's done, we hope that we will then be the only company that has an indication of interest -- excuse me indication of use for this product for the treatment of HCC. We think that’s significant.

And our next question comes from the line of Tom Gunderson with Piper Jaffray.

Maybe I can just start with some numbers, maybe you said it, I missed it but on overall revenues, Kent, can you split that between U.S. and OUS for the quarter?

Yes, we can. I can tell you that it was -- I am rounding off here $64 million and $37 million for domestic and international -- or in other words, the 37% of our revenues came from international, 63% domestic.

And that 37 is constant currency.

That is -- no, that’s adjusted. To get another million if you wanted to change constant currency for a euro, we’d be at a million higher.

Fred, last quarter you mentioned I think your sales guy was there and said that it felt like overall, procedures were down in the U.S. How does it feel in Q2 and going into July?

We’ve got Marty Stephens and Monroe May [ph] here, Marty, I want you to address that. What are you seeing in terms of procedures in the U.S.?

We still see a declining procedures, most of the companies that are in our space as you see reporting there also, indicating that I've heard -- well you can read ranges. But despite the declining procedure count as you can see, U.S. sales are actually growing at double the rate in the second quarter that they did in the first quarter and actually we expect that will continue to be better as we get later in the year.

Tom, I will mention that I was talking to a cardiologist last night who is in one of the top 10 hospitals in the country in terms of interventional procedures, and his comments to me were that procedures in the business was flat. That's one hospital, but that's a pretty high-profile place.

And then Fred, maybe on the even higher altitude scale, you guys have a lot of OEM business and you have insights into what lot of other manufacturers are doing. Looking forward to the rest of the year and maybe into ’13, how is it feeling up there?

Your comments are really good observation in terms of what we get to see -- that business is up 15% year-to-date. And we continue to see companies out there that don't want to go out and tool for various types of capabilities, we continue to have a very strong advertising program. So the OEM business still feels very, very strong. Again, I would remind everybody that as you move into the third quarter it’s a little slower than normal, but overall it feels very strong. In terms of the business, we also see huge opportunities for growth in Europe. So it still -- and we have some accounts and some issues that are talking about $1 million or $2 million worth of parts. When you start taking a look at those kinds of volumes over the year and they are very significant, so it still feels fine. Now that being said, we continue to see the side where we have an OEM customer that buys inflation devices from us, so that’s kind of volatile and up and down. So my comments and the 15% I am talking about our ex that OEM customer. But for the rest of the business which I think represents about $55, $60 million. So it feels fine, in fact, if anything I think that it feels like as it is going to get stronger and that we are going to see companies less likely to go tool and come to a company like Merit. And for us, and we get about 55% or so gross margin on our OEM business. So it's a great business for us and I think helps to balance our overall performance as a company.

You mentioned China a couple of times and the 53.4% increase, what were Chinese revenues in Q2?

$7.7 million.

And that’s where the $30 million comes from for the year.

It’s on pace to do something like that.

Yes, that’s kind of where we think it’s going to be -- that’s by the way higher than we originally had forecast, but some of those products go to China, as you know I mentioned on previous calls, over the last year, 18 months we probably received I don’t know 16, 20 new licenses over there. Some of those products are just starting to ramp up. We’re selling our wires -- Laureate wires in China that started to ramp -- a number of our infusion catheters, a number of other products that are starting to ramp. So we're excited about the opportunities in China.

And then just last question, a quick one, as you mentioned Laureate and the 510(k), when did that go in?

It went in about a month ago, and we were 30 days into the cycle, I think was. So we expect to have a response back in about 30 days give or take, is that right Stephanie -- give or take. So the end of August, we should have a response back from them and we will respond to whatever questions they have or they could be satisfied. I don't know, we'll just have to see where it goes from there. In the meantime, as I mentioned that slack that was created has now been made up in the international markets in China and other places. So we’re going to be a nice addition to get that back onboard.

[Operator Instructions] And we have a question from the line of Jim Sidoti with Sidoti & Company.

A couple of quick questions. I just want to go over just the basics first. You were on the previous call I think you looked for EPS of around $0.60 for the year, I assume, you are still around that number?

We haven’t changed any forecast or anything like that Jim. We’re still on track.

All right, that’s what I thought, I just want to make sure. And the $2 million charge in the quarter that was about $0.03 to your bottom line.

That’s -- so you would tax that up at $2 million, takes 35%, that’s about right.

And then the med device tax, I assume some of the OEM stuff isn’t taxable, that’s why it works out to about $0.07 for the year.

I think that if we take a look at -- the fact that we have the international markets, we have the OEM and we have the technology companies, we are I think -- I didn’t want to say it’s reasonable because I think it’s unreasonable, but it is the law. But I think that we're in reasonably good shape in terms of having it not be as much as maybe some others. What are you going to do, Jim? There's an election coming, Jim.

There is. I wish I was sure of some other things as sure as I am about who you are going to vote for. On the Irish facility, it sounds like your best stop -- you are ready to start that up in the current quarter.

That’s correct. Yes, we’ve moved people in, we are doing some manufacturing there, we will start to ramp it up throughout the balance of the year.

So how does that affect your gross margin?

Well, you are going to have to depreciate it, it’s a good question -- you’re going to depreciate it and our job is going to be to go ahead and to make sure that we produce out of there to offset that the startup cost, the depreciation costs. So as we’ve added facilities, Jim, in the past, and added capacity, these things don't sit around baking for very long and -- one of the things I've alluded to in our -- in the press releases is -- and if I could, I am going to again bang the drum for a minute. Last year we've introduced the blue diamond, we introduced the big 60, we have a new inflation device called a basic touch, and we have a new hemostatic valve. These are all high margin products, they are franchise products. And these are all going to be built -- the hemostatic valve is going to be built in Ireland. So the new snare is being built in Ireland. So we have products coming through there that are going to I think help hopefully offset. It’s good -- one other point, that business if you talk to our general manager and I and you can't, but I talk to him everyday. He talks about how busy they are, how -- so you look at our snares and inflation devices, you take a look at our hemostatic valves, many of our OEM products. And remember we are getting this performance with really our Laureate only operating at about 50% of what we could, that’s going to get. So that’s been an expense and now we are going to fill that back up. So the bottom line is Jim, I believe that we are going to offset that depreciation expense with just the growth of the new products and the Laureate coming back online. That's what I believe the outcome will be.

Now could there be just for a quarter or 2 or little bit of a backward move on the gross margin?

I am not going to say that. What I will say is that you are going to have that expense. I mean it’s clearly going to be there as we bring this online and -- but to say that we are going to back on the gross margin for the quarter, I am not going to say that.

And our next question comes from the line of Jayson Bedford with Raymond James.

Few revenue questions, the jump on BioSphere sales, what are you seeing the strength, is it on the women's health side or more on the oncology side?

We’ve got it seeing across the board -- we are seeing it also in worldwide markets, some of it is the geography part of it and coming from all sections. So it’s kind of across-the-board.

I will say that the strongest one of the 2 is the QuadraSphere, cancer cell stuff.

And then Endotek growth, is it largely new product driven or are you seeing pull-through with other product and kind of expectation on breakeven on that business?

The growth is coming from our new EndoMAXX stent, the big 60 and some of the other accessories. If we take it back out the intercompany interest expense for the quarter we lost about $140,000. If we take a look at that 140,000 and then back out a couple of million dollars that will come out of costs because of the news -- lower cost of the stents and by the way you will recall that we have taken out almost a 1/3 of our cost of goods for a stent, a 1/3 of the cost of goods significant, that would be almost $500,000 a quarter. So that is another positive side of this is as we move into next year, that’s going to go from a loss of $140,000 hopefully into a position that you could be making 250,000 or 300,000, $400,000. And then we have a bunch of new products that are coming to market on top of that. So that thing which has been I guess beat up, but we haven't given up. And that it’s going to become a significant contributor to Merit’s revenues and Merit’s profits and gross margins next year -- substantial. We could end up instead of losing $1.5 million like we did the first 6 months last year, we could make $1.5 million. That's a pretty significant swing.

In terms of the tenders in Beijing, I am guessing you haven’t really benefited from that just yet. Is that fair?

But you know what’s interesting about the tenders, it was much to do about nothing. They never really did it. They talked about it. Business is moving along, the new products are being sold, and it just kind of vanished. So it may come back. So it's been to our advantage, but in the meantime, there were people waiting on Beijing, they wait in Shanghai, and Guangzhou and other places, they just start buy the products and they kind of go, "to heck with that" and we are going to get patients to treat. So this kind of went way.

What’s the approximate -- or what was the approximate run rate for the Laureate in the U.S.?

Was the run rate -- can you clarify what you are asking?

Jayson, we’re all going to be guessing around the table and I don’t have the number. But we will call you back and give you the run rate. So that I understand, are you talking about -- before it got pulled back, or are you talking about the run rate now?

Going into 2012, you expected to be selling Laureate in the U.S., how much did you expect to sell on rough basis...

It was about $5 million to $7 million is kind of what they were looking at for a run rate. And by the way, I think it’s a good point. You take the currency and pull a $1 million out, and then you take out for the first 6 months $3.5 million, that’s $4.5 million of potential revenue we could have had that would have been very nice. But we didn’t, but we still hit that 10%. So I think these are all positive things and things that should come online in the future. So we’ve done it without it. And we are fortunate to be able to do that. But when we add it on there, then that would be nice, that will be very pleasing to have that back online. Remember this was -- well, I have said enough.

Just on the benefit on the cost side from the fluctuations in FX, did you see more of a benefit from the euro or the Mexican peso because I think you do have a manufacturing facility down there.

The Mexican peso is fixed in dollars for us. It can affect us as we go forward and negotiate new pricing but it’s not immediate. So there was nearly $1 million in cost sales reduction due to the facilities and so forth in Ireland and France, our manufacturing cost of sales and additional cost savings in SG&A as well. So it’s almost exactly the same as sales dropped $1 million, so did the cost of sales.

We have a question from the line of Ross Taylor with CL King & Associates.

Just couple of simple questions. I just wanted to focus on the U.S. for a minute. Your growth accelerated a little bit in Q2 from Q1. It sounds like in response to an earlier question, you expect growth to accelerate a little bit more in the second half and what’s driving that exactly? Is it your new products, bringing things like Laureate back to the market? I just wanted to ask that to start off.

First of all, Laureate is not back in the market, but it will drive it in the second half assuming that gets put back in place in the second half. Whenever you start up the first -- the first part of the year, you always kind of get that lag that comes into January, it seems like it's very slow for the first couple of weeks. And so I think that's part of what's going on, and plus we have just seen the procedures seem to have slowed down. Almost everybody we talk to says they are flat to down. I think the numbers if you take a look at other players would seem to suggest that. I think to go to your question of what will improve it, it will be new products. But I think the other thing that we’re doing is I think it really comes down to management. Our guys are spending more time at training making sure that they're focusing correctly. We have more clinical people. So I think a lot of it is just the internal part of sales and I think they kind of get -- they got to get a punch when they got in the first quarter, and I will tell you I am looking at these guys right in the eye here, and they don’t like it. For many years they kind of drove it, and all these other guys were kind of in the back and these guys are very competitive guys. And I can just see right now they are saying, they are kind of looking at me and saying you haven't seen anything yet and I'll say that you guys will bring it on and let’s see what you can do. But I don't think they like it, so I think a lot of it just focused, particularly the management team and going down to the regional managers, the clinical people and candidly account management. I think that's the other thing is that we are looking at, kinds of services and the breadth of what we can bring to our account. So we have a lot of products, a lot of opportunities, and I expect that these guys will kind of pick it up as we go into the second half as well.

Those new sales people we hired during the year are going to get better as time goes on.

Yes, that’s another point. We did hire some more folks and they go through that same training cycle. It's usually 6 to 12 months, and some of those are going to be coming on, you will see some improvements there as well.

And the prostate study of the job you mentioned, I suspect at least initially you are going to start off with a pretty small study, but should we be factoring any material increases into our R&D expense assumptions related to that?

There is going to be a cost over the period of about $1 million to $1.5 million, it's relatively inexpensive, I mean for what the opportunity is. So that’s expense, but it’s pretty well fills in and fills in with where our overall expense lines are. So the expenses, there are some other things that will forgo, some other that will pull back in to make sure that we can fit into our budgetary numbers.

Last question is, I just wondered if you could give any color on the status or progress of the OsteoPro, what’s happening there?

The OsteoPro is a great product and has great gross margins, and I think probably one of the great things about it, if you take a look at what it does -- I was talking to a cardiologist in Florida the other day who called me and said he was doing a case and he explained to me how he used it and how it improved his ability to deliver the stent to a patient. He said and now I am going to take this and I am going to make sure all the other guys have an opportunity to do this because this is an important product to make sure that we serve our patients properly. The other thing that it does is part of this concept that I talked about earlier where we moving from these accessories to primary use. This allows us to get in front of the physician. This is the same guy that's going to -- or a girl that in the future is going to buy our vena cava filters. They're buying our guide wires, they're buying sheets, they are buying things from us that technicians and cath lab supervisors don't buy, physicians preference items. I can tell you that I probably hear 30 stories about accounts, or physicians that we haven't been able to get contact with or this and that, and this is a door open. I would say all in all that it’s doing fine. We have not even introduced it yet in Europe or other parts of the world. So Marty, do you want to comment on it at all the -- you are the guy that’s selling these things.

It’s a technical sales, it's a little bit different like Fred said than our typical accessories that we have had. So the uptake is a little -- takes a little longer and you have to face-to-face with questions, be in specific cases with him and so it takes a little longer, but we are seeing growth in it. We think it’s going to be a long-term winner for the company.

Ross, one of the things that -- one of the sales guy said it, I have been trying to talk to them about fluid administration for a number years, couldn’t get anywhere. And that he went in and did the case with a physician and the guy was saying, well, how can we not doing some of this stuff, and he turned to his staff. This is the physician now and said, "Hey, I want to look at this guy’s stuff, make sure you get them in here." That’s worth a lot. So the product is great, it opens a lot of doors, it’s got great gross margins. But it's a longer sales cycle because these things, remember only represent in 7% of the cases for cardiology. So that being said, we are there. That’s part of the reason why that sales force expansion was to make sure that we would have smaller sales territories, that was part of it. There were other reasons. So all in all I am satisfied with it and it allows us -- kind of put Merit on the map, no that our other things don’t, but it’s kind of a big deal.

Thank you. And at this time I am showing no further questions in the queue. You may continue.

Well, ladies and gentlemen, thank you for your questions. Kent and I will be available for the next couple of hours to answer questions and to clarify for you. We want you to know that we understand the tasks. At the same time we want to make sure that you understand and I think you can sense that we continue to have enthusiasm about our business in the opportunities for worldwide business. And in fact, more so than ever as I take a look at my competitors, and I take a look at how Merit’s positioned, it gives me a great hope of the future for the opportunities for this company that our goal is to reach $1 billion and to get better than 50% and to get operating margins of 15% to 18%, all of those are goals. And we’ve worked hard to put the mechanisms, the structure of the facilities and the worldwide footprint to put those in place. Now those are all bold, those take a lot of work. I am looking at my staff out here and they look like they need to go home and get some sleep. The point is that we’re committed to deliver. We are working hard. We’re not perfect. We will make some mistakes, but we set out some things we wanted to do this year. I think to this point we have done exactly what we said we were going to do. So we look forward to reporting in the future, we have a number of conferences coming up here as we roll into late August and September and then into the fall. And we’ll look forward to reporting. And we will be able to, maybe hopefully about that time have some clarity on a number of these 510(k), new products rollout strategies that I think are going to be something that you're going to I think have great interest in, as well as some of the other business and structural issues like the nanotechnology, like the hypotube business and some of those areas as well as our geographic expansion. So we continue to be committed to the business and we know what's, what we need to do. We thank you again for your interest. We will be available. We look forward to your calls and we wish you good evening. Signing off from Salt Lake City, and a very good evening to you. Good night.

Ladies and gentlemen this does conclude our conference for today. We thank you for your participation and at this time, you may now disconnect.