Fred Lampropoulos
Analyst · Larry Solow with CJS Securities
Thanks, Kent. And again, I think the one little issue there on the impairment cost was -- had to do with an investment that Merit made in an Irish company on a technology that we have actually transferred and so Merit actually acquired the rights in producing that product here. But the equity part of that investment was the part that we impaired. So I appreciate that.
In the fourth quarter as you can imagine we were very busy with all the work that is necessary to do a transaction. Let me address the Thomas Medical Transaction for you, it’s been now about 2 months. Part of that of course was during the holiday and I will tell you a little bit about what our thinking is today about the transaction. I think that we thus continue to feel that Merit’s entry way into the basket or access market via the cardiac rhythm management business is something that’s very comfortable for us, both in terms of the technology, the personnel that we have brought along with the deal here and the opportunities worldwide. We have dispatched 2 Merit employees, long time employees to Malvern, Pennsylvania where they will act as, in the RD capacity and the Managing Director of the facility, to essentially meritise the product.
We are convinced and believe, and I think this -- the numbers will hold this that the splitable, peelable sheath is the gold standard worldwide and I think that is clear and evident when it is being essentially utilized but all of our major large companies, the big four, the big five depending on your perspective. Now one of the challenges is that there was a lot of product that was put into customers hands in the fourth quarter and if you can just think for a second, about $1.9 million or so coming to us, just the last 10 days over Christmas.
There was a lot of product that was moved forward, and it was a busy year for those guys. Now that means in the first quarter like you would have when people are trying to fulfill contract requirements for pricing reasons that you’re going to be a little dry. And so it is a little bit slow and will have some effect in the first quarter in terms of the transaction.
I think on the positive side, many of these accounts that are Merit accounts, as well as belonging to the larger companies are starting to ask and convert to a direct method, maybe faster than we had anticipated. And so Merit will meet our responsibility to our OEM customers, but at the same time we have a sales force of almost 200 people worldwide and when customers ask us when those opportunities are available, it is our full intension to meet those needs of the customers. Now clearly when we do that, we get higher margins as well.
Now another thing that we’re doing is that the facilities in Melbourne were running 3 shifts. And so that was quite a difficult thing to develop new products. So we have no less than 3 or 4 new projects that we’re moving forward on that are improvements of our technology and products that you will see this year and next year. They have to do with steerable sheaths, they have to do with improved splitable sheaths, they have to do with non-valve sheaths, they have to do with a number of other products, again all essentially our same call point. So we believe that this is a great opportunity for us and remember these are accounts that we were calling on. These are EP labs and places where we’re selling wires and trays and kits already. And now we’re able to expand this on a more direct basis. Also as a point of interest. And I think this is another -- it’s actually a very big deal.
When we acquired the company we had certain manufacturing rights to certain products but not distribution rights. Subsequent to closing the deal, we come to an agreement with one of our distribution partners, in which we’re not allowed to sell under Merit’s label, coronary sinus guides and to sell lateral vein introducers plus Merit has 2 of our own products that we’re now labeling under our brand for these products. These will rollout over the next 60 days, this is kind of a big deal.
Now again we have to compete with some of the big guys but we’re -- we’ve been doing it for a very, very long time. So, I’m still very excited about this opportunity, about the technology, about the margins and those sorts of thing. But as a reminder, in our first quarter it was a little dry in January, it’s a little bit dry in February and we think that this will start to accelerate as those pipelines that were full now start to empty out and have to be rebuilt as well as Merit’s own direct effort worldwide.
I want to come back a little bit to our sales channels and this is going to probably be a long call today because there are lots to talk about. So I hope you’re sitting back and you will be patient with us.
In many ways as we’ve discussed throughout the year, our international markets have been kind of the stellar areas for Merit. So we have areas, for instance, in Europe where our direct sales force in Europe and what I think all of us would agree in a very difficult environment, although improving somewhat on a local currency basis, grew at 13.7%. And I think I was looking at a competitor the other day and they had anticipated growth in the low single digits. So I mean when you compare this, it’s probably significant and I think talks about the investments that we made in the past and how they paid off.
Our Endotek division was kind of the star of the show. This year they grew at 32% and as I think I’ve mentioned to you, this is a company or division that’s been underwater and we expect that this year because of a number of initiatives that we took that this company will turn profitable and we’re excited about the opportunities in this division. Worldwide dealers, we’re talking about the Pacific Rim, Central South America, Canada, China, grew at 32% last year. Even our Chinese business on a standalone basis, grew at 28.7%. So I think our European dealers grew at almost 25%.
So as you can see, much of our sales and our growth is coming from international markets. Now we will talk in a minute about what we think we will do to revitalize our domestic market, but I think that we’re very pleased with that. That has a number of implications in terms of the device tax, and so on and so forth because those revenues are not taxed. So I wanted that we kind of go through those sales divisions and we would expect that we will see similar results this year although we would expect to see a higher U.S. direct sales number as well with new products.
Let me talk about a couple of businesses and things that we’ve not talked a whole lot about in the past. But we think that are going to have a significant impact on the business. We have initiated production and sales procedure tax in our Irish facility. Now some of you will remember, several years ago, when we bought a small little struggling company in Richmond, Virginia and that business is doing sales now in the mid-30s, but I think more importantly not only is that business profitable, but what it allows us to do and in terms of pull through, access to the accounts and sell all our other products, and so in the last five years while that business was accelerating and growing in the 20s and 30%, our gross margins were accelerating as well even though generally you’re going to see gross margins in that product to be almost half, maybe a little more than half of what our overall business is. It does help to pull through all these other products. So, that business is started up in Ireland, it's in our new facility, and we are excited about what that will do for us over time. Now this year it's probably going to be $3 million or $4 million, next year it will probably be $7 million or $8 million, but it's something that I think helps to pull along a lot of our other products.
Let me talk again for a minute about research and development, and new products that Merit is introducing, because we think this is a very, very big deal for us going forward. We have the new ONE Snare. The ONE Snare is a Snare that is complementary to our EN Snare. It is a product that we are receiving great reviews. It is essentially released in the U.S. and European markets and being registered in international markets. And let me assure you that this is a complementary product in the Snare business, you need both the three-loop and a single-loop, and to the best of my knowledge Merit is the only Company that can offer these products and we’ve improved what had been in the market for 20 years, and I would expect that by the time we get through the end of this year on a ramp basis that Merit will be the market leader. We have about 35% market share right now. I think we will grow that market share by over 50%, so that would put us over 50% for the year on a ramp basis by the end of the year, so we’re excited about that product.
We have a new product called the basixTOUCH. Now, all of you know that Merit is the world leader in inflation devices, and you also know that over the last 18 months Merit has introduced more inflation devices including the BIG60 which is used for dilatation of esophageal balloons. You are aware of our Blue Diamond. You now have the basixTOUCH, and now for the very first time mention the basixBOOST. Now I’ll just mention it today, but it's a preview of coming attractions that has to do with TAVI procedures and it has to do with valvuloplasty and the placement of AAA types of stent graft. Now that’s something that I’ll tease you with today, but I want to come back to the basixTOUCH.
The TOUCH is a device that we believe will sell at a premium. It is a device that holds over 30 ml of volume. It has 35 atmospheres of pressure, and based on a count yesterday in a discussion about it, 9 improvements. 9 reasons and advantages over our competitors. 9, not 1, not 3 which we typically tried to look for at least 3, but 9 distinct advantages. This product will be CE marked by the 1st of March. We will file also on that very same day a special 510K, which goes through a 30 day mandatory review. I can’t speak to the issues of the FDA and their approval process, but generally these things are accomplished in at about 60 days.
That being said, in addition to that, we are going to be launching the PHD, Push, Hold and Deliver. And this is a new Hemostasic valve that we’ll be releasing in May. These are 2 very, very significant products that are going to generate millions and millions of dollars of revenue, and they’re going to all have above average and I’m talking about 60% to 80% gross margins depending on the product. And we believe based on the input from physicians and prospective customers that this is going to take a substantial amount of market share, not cannibalize Merit’s existing business, but go out directly against our competitors, to be very honest, that there’s no way they can compete with this product. It's that good. So that’s something that you can look forward to, it's on our doorstep and we’re looking forward to that. So, there’s the basixTOUCH. We’ll have a new Aspiration Catheter developed here at Merit. We have the new bearing PVA. It was a product that we developed from scratch out of our embolic division in Roissy, France to go along with our Embosphere’s and our HepaSphere’s. And so that will be the first new product that’s come out of that division and we have several other embolics that are under development.
We have the EndoMAXX EVT, esophageal stent that we will start selling. This is the stent that has the valve. We recently have received approval for our Merit SureCross support catheter and that is being manufactured by one of our vendors for us, but Merit is the owner and a number of other products. I can look at the board, a snare system, I can look at the coronary sinus. The net of it is this. Merit has never had a portfolio of new products that ever even approaches the stuff that we’re doing here, and we haven’t even talked about our new Hydrophilic radio sheath that we have. And that radio sheath business for us last year grew faster than any other part of our business, I think, it was 345% last year for our radio scan. So it was a huge opportunity. We also have the Coronary Guide Catheter called the Concierge. Well you’re probably getting tired of listening to this, but what I’m saying is, we’re loaded, prepare. Now, let me move on and talk about the very challenges that we have, and then what our plan is and what our guidance is.
So, you’re all aware of the challenges that are facing all medical device companies. Let me go over a few that Merit is facing. In this next year we’re going to face interest expense of about $6.5 million to $7 million. This is essentially new expense and this is associated with the purchase of money that we borrowed to acquire Thomas. Because of the Thomas acquisition you’re going to see amortization of intangibles, and Greg, I trust that this is based on the new calculation, but give or take of about $6.4 million. The Medical Device Tax is estimated at $4 million to $5 million. And I would tell you that if our friends at the IRS will look at the check that I signed recently, they will see a large teardrop, because I’m still somewhat beside myself like everybody else is in terms of the Medical Device Tax and what it means to companies. Essentially taking 20% to 25% of your after-tax profits. It's outrageous, but it is the law of the land. So businesses have to adjust.
We are still proceeding down the road of the clinical trial rout with our QuadraSphere in our HCC study of doxorubicin and other smaller expenses that we have associated with trials. We are going to have some moving expenses. I am going to talk about our new facilities and why we built these new facilities, and what you can expect. So, about every 5 -- when we plan for facilities, we plan for about 5 years. And it's been about -- it's been 7 years since we built our last facility. In the first year that we were in that, we had lower gross margins as we were not being able to apply it and the building wasn’t full, but part of why you saw our gross margins increase every year is, we became more efficient, we utilized the equipment in the facilities.
We have been, I think, relatively inefficient in some of our production here in Salt Lake City, its 5 miles away. And we have to load up all the parts. We have to send them all the way down there. We have to hand load and send them all back here and that’s inefficient. It's in the place where we started our business. And so what we’ve done is we’ve built a new facility that will come online in the first quarter, and we’ll work over the next 6 months as we shutdown one of our satellite facilities and move that production here. Now the question will be and it's legitimate, why would you do this? I mean if you’re going to have more expense, why wouldn’t you just keep it where it is? Well there’s a couple of reasons. One, we’re not going to have enough room as we continue to grow. It's very inefficient because of the areas that -- and the distance and the people to handle all the material. This particular facility is one of the most advanced manufacturing facilities in the world. And for those of you who have been to our molding area and to our automated chipping area, if you come here you will see essentially the same thing when a part is molded, it will essentially go right into a fulfillment center, go on the floor, get produced into a product and go to the sterilizer. It will come in one door and go out the other.
We estimate that we will be able to avoid hiring probably over a 100 individuals as this comes online and we’re able to either absorb those or eliminate those positions over the next year or so. It will take time to do this, because we cannot miss a customer’s order, so we’ll move one cell at a time. But you’re going to have the additional expense of maintenance and security and heating and air conditioning and those sorts of things. But once this thing gets online, it will give us about 5 years or better of production capacity and it will allow us to eliminate and remove a lot of cost to make this much more competitive than the relatively inefficient way we’ve done as we started the business up and then built it out, and have these facilities that are scattered over the Salt Lake Valley. In addition to our campus here we have over 300 employees that work in other facilities just a few miles from here. And you have to have secretaries, you have to have receptionist, you have to have a lot of duplication, plus you have to have all the people who have the equipment. Enough said about this, it will come on here relatively shortly and a little bit at a time but there's going to be expense there. Kent, I’m going to let you just maybe weigh in, if you want to, for a second.