Merit Medical Systems, Inc. (MMSI) Q1 2019 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and thank you for your patience. You've joined the Merit Medical Systems First Quarter 2019 Report. At this time, all participants are in a listen only mode. Later, we will conduct the question-and-answer session and instructions will be given at that time [Operator Instructions]. As a reminder, this conference maybe recorded. I would now like to turn the call over to your host, Chairman and CEO, Fred Lampropoulos. Sir, you may begin.

Thank you very much, and good afternoon ladies and gentlemen, on this beautiful spring day in Salt Lake City. Thank you for taking the time to join us. And we have, I think an exciting report and some good information about the Company. We'll start out by having Brian Lloyd, our Chief Legal Officer read our Safe Harbor provision. Brian?

Thank you, Fred. During 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, which are not purely historical, may be considered forward-looking statements. We caution you that all forward-looking statements involve risks, unanticipated events and uncertainties 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 and filings with the Securities and Exchange Commission available on our Web site. Some of these risks are identified in our press release and slide presentation distributed in connection with this call. Any forward-looking statements made in this call are made only as of today's date and except as required by law or regulation, we do not assume any obligation to update any such statements, whether as a result of new information, future events or otherwise. Please refer to the section of our presentation entitled disclosure regarding forward-looking statements for important information regarding such statements. Our financial statements are prepared in accordance with accounting principles, which are generally accepted in the United States. However, we believe certain non-GAAP financial measures provide investors with useful information regarding the underlying business trends and performance of our ongoing operations, and can be useful for period-over-period comparisons of such operations. The tables included in our release and discussed on this call set forth supplemental financial data and corresponding reconciliations to GAAP financial statements. Please refer to the sections of our presentation entitled non-GAAP financial measures and notes to non-GAAP financial measures for important information regarding non-GAAP financial measures discussed on this call. Readers should consider 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 items that affect net income. Finally, these calculations may not be comparable with similarly titled measures of other companies.

Brian, thank you very much. Ladies and gentlemen, again, thank you for joining us. And as a reminder, you can go to our Web site where we have our slide deck in the Investors Section to follow along and to have some backup for our comments on the business today. Let me give you a general overview of the business and the first quarter. A reminder that as we have historically guided in the first part of the year we have a lot of expense; we have our sales meetings in Europe, in the United States and the Asia; we also have our incentive programs for our top producers; and so we usually see a higher amount of expense in that first quarter, which we have all accounted for. I think as you look at the business, you will see that we are on the top side. And the first thing I'd like to discuss is our core growth. I think it's a significant issue and opportunity. You will recall that as we look forward to '19 and to 2020, we had moved up our core growth. And I'm pleased that we were on the top side of that, particularly in the first quarter. And so I'm very pleased with those results overall. I'm going to give you a little bit more color on our -- on my comments, I'd like to talk about a few things. I'd like to start out by talking about the core growth, the fact that the business is strong and the pipeline is full. And I would say our business continues to be very robust. Something I want to point out that we've been asked and we are often asked, and I'm sure I'll be asked again after when we get to the Q&A, about Terumo. Raul and I have done a lot of work. In fact, I won't take any credit for it. Raul has done a lot of work in taking a look at the numbers on our products that we sell. And I think you are going to find these quite intriguing, because you all know that Terumo is back in the market. Well, it's hard for us to assess and we do this for living every day, the extent, the areas, the shortcomings and so on and so forth. But what I do want to point out to you, on a reported basis, when we take a look at sales of the products that we believe that we compete with, which are guide wires, our micro catheters, our hydrophilic and diagnostic catheters, some of our sheets and so on and so forth. We find that if you look at those numbers over the year ago quarter, now this is for the first quarter. Our reported growth of both product lines is up 44%. That does not include the Prelude Ideal which is a new product, which is Merit's fastest growing product in years that's been introduced, and that would be on top of that. But if you look at that, I think it speaks to the opportunity that we have spelled out and we have pointed out before about the fact that the momentum in the business and the fact that Merit has a broad product line to compete with anybody in this area. But I think this one speaks volumes as to where the momentum and this is in the first quarter. The other thing I'd like to talk about, and add a little more color to, is Brexit. As many of you know, Brexit came up to a deadline and that has been extended and that's all well and fine. We were ready in any event. So had it been at the end of March, Merit was ready for it. But we are in full operation in our facilities in Europe and in Great Britain. And so, that's something that we're already prepared for regardless of what happens. But it does bring up I think another issue and one that's been raised by a number of investors, and that is what happens if we get to a single payor system? Well, this is a lot of speculation. And we have dealt with over the years the what-ifs and all the things that people can imagine. I want to remind everybody that almost 50% of Merit’s business comes from international markets. Many of those markets, if not all of them, have what we would call single payor systems in Great Britain. And yet, if we look at Europe today, we'll find it's the fastest growing along with China and other areas sections of our business. So the argument is well you might get lower prices there. But again, if we look at our business, we find that there's quite a bit of ability to distinguish your products, bundle your products. And when you have a full capability of products and you have the distribution that takes care of issues like Brexit, it spells out an opportunity, not something that I think takes away from the business. To move on, let's talk about Becton Dickinson. We are coming down the road on the Becton Dickinson transaction in terms of moving the facilities. We are now producing some products in our facility in Mexico. And I will say that we've invested heavily in new equipment, in training and in transfer. And remember, we were moving six -- products from six different facilities. Our guys have done a great job. In addition, Merit will be introducing before the end of the year, new products that Merit has developed that will enhance and complement the existing product lines in Tijuana as part of our biopsy product line. And then finally, in Cianna, I want to talk about that. Listen, we are performing slightly ahead of our expectations. And again, in the first quarter when you can do that, I think it bodes well for the balance of the year. So we're excited about Cianna. We continue to believe it's a great opportunity and the fact that we are in fact through the transition period. By that I mean we are shipping inventory out of Salt Lake City and out of Richmond. We're doing all the billing. We've maintained a sales force. We've essentially had no fallout other than we've had a couple of situations where there were a couple of issues or things that we had to make some changes. But our goal to maintain the sales force, maintain the R&D and develop new products out of Cianna, I think is moving along. So all-in-all, I would say that the first quarter met and exceeded our expectations. And we expected that’s a good foundation for growth for the balance of the year. Now with that said, I'm going to turn some time over to Raul Parra, our CFO. And Raul, I'll let you go through the numbers and massage those a bit.

Sure, thank you, Fred. So we'll start with revenue for the first quarter. It was approximately $238 million as reported, a 17% increase over the comparable period of 2018 and approximately 10% on an organic constant currency basis. Acquired products contributed revenue of $20 million, of which Cianna was $12.8 million of that and we had excess headwinds of approximately $5 million. With most of our divisions contributing for the quarter, we have strong sales in standalone product, catheters and CRM. Our gross margin on a GAAP basis for the quarter was 43.9% compared to 43.4%, a 50 basis point improvement for the comparable period. Non-GAAP gross margin for the quarter was 49.2% compared to 47.5% for the comparable period, a 170 basis point improvement. We picked up 30 basis points of our 165 basis point to 240 basis point improvement. We are looking for, from our 2018 full year baseline of 48.9%, pretty strong start there. OpEx Q1 2019, total operating expenses as a percentage of revenue on a non-GAAP basis were approximately 37%, which is in line with our expectations for the quarter. And that's we guided that higher expenses, Fred mentioned it in his opening statement, sales meetings and shows and it's a heavy operating expense quarter for us. Our tax rate on a GAAP basis for the quarter was 10% and 17% compared to the 17% for the prior period. Tax rate on a non-GAAP basis for the quarter was 21% compared to 23%. And we continue to benefit from stock option exercise and the tax reform. EPS, GAAP earnings were $0.11 compared to $0.10 for the comparable period. Non-GAAP earnings were $0.37 for Q1 compared to $0.31 for the comparable period, a 19% increase over the same period. A few other items of interest for everyone; debt balance was $384 million; a leverage ratio of 2.2 on a gross basis and 1.97 on a net basis; we paid our debt down by $11 million; working capital was 243 million; CapEx for the quarter came in at $18.3 million; D&A of approximately $22.4 million; and stock comp expense of $1.8 million. So overall, we have three quarters left but I think we're off to a good start. Fred?

Well, Raul, thank you very much. Listen, I know there are other calls going on today. I think that gives you the core of what we wanted to talk about. We continue to be enthused about the business and the opportunities. As I mentioned, the pipeline is full. We've recently received a number of regulatory approvals. We don't generally talk about those and I won't go into those specifically. But the business is poised to I think respond and to take advantage of the marketplace and the opportunities. So with that said, I think that pretty well covers it. So we'll get to the questions and try to keep this at a minimum, but the lines will be open. And as a reminder that after this call and the questions for clarification, Raul and I will be around for an hour or two to answer questions that you may have and to clarify points for you. That being said and with that being done, we'd going to turn the time back over to our administrator. And we'll start answering your questions to the best of our ability. Thank you again for attending.

Thank you, sir [Operator Instructions]. Our first question comes from the line of Jim Sidoti of Sidoti and Company. Your line is open.

Fred, when you were talking about products that compete against Terumo being up 44%, you said that excluded the Prelude Ideal, I think. Can you give us a little more color on how that process product, Prelude Ideal is doing?

Jim, it’s been one of the most successful products we’ve done in years. I was looking at some numbers earlier today. Again, it was a product that we just launched last year in March of '18. And in that month, we did $57,000 worth of revenue. For the month of March this year, we did $570,000 in revenue. And the reason it’s so successful is that we’re selling in Japan. We recently got approval in Japan. It’s in U.S., Canada, Australia. And this is this metal reinforced seat for radio procedures. So Jim, when you do these R&D projects, it's nice when you have one like this they don’t come along very often. But to be able to essentially pick up about a 10% market share in your first year is I think extraordinary. And we just have a lot of high hopes for this product line as we go forward.

And my second question has to do the deal announced last week, Medline acquiring Namic, there's positives and negatives to that. So I think Medline might have been a customer of yours. Can you give us some sense on how you think this all plays out?

Well, first of all, Medline is one of our customers as well. We've worked with Cardinal and Medline and Avid, Owens & Minor through distribution where hospitals require agreements, and Merit provide certain parts of kits for standalone products, so that’s ongoing. I would generally say this that first of all, I think it’s interesting to know, Jim, that when we started this company, it was to emulate Namic, they have great products. But whenever you have disruption and you have a product moving from a non-competitor to a competitor. And by that I mean you’ve got it moving out of angio-dynamics and into a company that competes with several other companies in that distribution and in that front line manufacturing. It creates opportunities both on the national accounts level, and that’s sort of thing. I can tell you that there are a number of conversations going on as people try to figure this whole thing out. The net of it all, Jim, is that I believe that it's a net plus-plus to Merit. And of course now all this has to -- you’ve got first of all, this deal sitting out here, it's going to take several months for it to close. But we view it as a big opportunity for the Company, not just in the U.S. but globally, because no one really knows what’s going to happen with all of those relationships. And it creates doubt whenever you have doubts, and you have disruption if there’s opportunity there. So, I think that’s way for me to answer your question. Raul, do you have a different -- do you have any other thoughts on that?

No…

Okay, all right. Okay, Jim, go ahead please.

And then the last from me, you didn’t make any comments regarding your guidance you gave for '19 and '20. So I assume based on your results that everything you were thinking three months ago was pretty much intact?

Yes, I mean I think our business is -- I don’t see that anything has changed. I think that there are a number -- if I were to -- again let me restate that. No, I do think that there have been some positives that are over and above some of the things that we talked about. There are always headwinds. But I think there are more tailwinds. We’re feeling a breeze to our back. And I’ll just leave at that, Jim, without going into any detail. But I think I would be more positive about our business, just looking at today from what I did just because of some recent developments and opportunities.

I think historically you've always maintained outlook after the first quarter that takes you at least to the back half of the year before you make any changes. So I assume that -- I mean, expecting to make any changes this afternoon?

No, we wouldn't do that, especially as you pointed out as we went and expanded these years and that core growth, I think it's prudent for us to watch this next quarter. It will then be ending the summer quarter. But based on what we see and how we feel about the business in our optimism, we will play it by the year and we'll see where we are in another 90 days or so.

Thank you. Our next question comes from the line of Larry Biegelsen of Wells Fargo. Your line is open.

It's Adam Maeder on for Larry, thanks for getting the questions. I wanted to start with one on the top line and ask about the cadence of growth for the remainder of the year. You did 10% organic in Q1 to hit your full year guidance of 8% to 10% implied high single-digit growth in the second half the year against more challenging prior year comps. So what gives you the confidence in achieving that level of growth in the back half? And then I had a follow-up.

I think its new products. I think it's the momentum of products like the Ideal, the Sync, which is the closure device. I think a number of new products that are in the pipeline. Some of which you can see on our website. I think it's generally -- I was talking to a sales person yesterday, you can talk about -- I don't know that there is any better information than information you get from your sales force. I was talking to one of our sales people yesterday in California they were talking about new account. In fact, I'd called them, because I noticed that they opened new account, and I was happy with the results. And as I talked to them, they started talking me about these other evaluations and things that have passed the back committees. And you start to get a sense about how things are going, what the momentum is, people that are obtaining to meet the leadership clause. And you start to feel the momentum of the business, you start to see things. So I mean a lot of -- of course its numbers, but it's really attitude that drives numbers. And I talked to two or three, or four of our sales people every day. Just when I see something that they do, I call them and thank them. So it's really just feel of the momentum. When you go to a basketball game like the Utah Jazz when they're playing the Houston Rockets last night, you can see with that momentum and it wasn't going to weigh and it didn't and we beat it by 16 points. Please don't remind me that we have to go to Houston on Wednesday. So that’s the answer to your question, momentum watching the activity and listening to the sales force is like anything else in sports, or anything like it's just a game and it's all about attitude momentum.

And then Fred as a follow-up, you talked publicly about a competitor device going out patent in mid-May in the U.S. I think you said that’s in the insulation devices space, anymore details you can share. What's the magnitude of the opportunity from a revenue standpoint? And what's embedded in the guidance for this potential opportunity, should we be thinking about this purely as upside? Just trying to understand how you are thinking about things. Thanks for taking the questions guys.

Well, let me just put it this way that we have a product that we'll launch on or about 19th of May, so we're less than a month away. We have been selling the product with great success at the international market for the last three years, sold hundreds of thousands of units. It comes off patents and we can combine it with a number of our products. That's really what I'm going to limit it now. But I will say that, it's first time to think, we put in our forecaster and I'm looking around them, it is not in our forecast. So, it is upside. And as I can tell you, there's a high gross margin products well above our corporate average, and something that we think is going to be a great advantage to us. But again, we'll let it play out and you'll see a shortened numbers, you see a little bit in the second quarter, you start and you'll start to see it ramp from there throughout the year. And once that day can pass, we'll talk about it openly or in our next call. But until that time, we're going to keep it kind of limited to what I have talked about in these comments.

Thank you. Our next question comes from the line of Jason Mills of Canaccord Genuity. Your line is open.

It is David on for Jason. Can you hear me alright?

That's fine.

First on Cianna, coming in stronger than expected. Could you provide some color around kind of the rollout so far? And was there other any kind of one timer or is there big customers that contributed the growth in the quarter? And then kind of how you sink the impact or how you think kind of growth would be on the top line and gross margin contribution given the growth in the quarter?

Yes, well, first of all, I think with Cianna, there's a couple of things I think they're important. We -- as you recall, we did not -- we maintained their sales force and we think that was a critical thing to do. We also didn't try to go out and one fell swoop and then throw it all into our Merit sales force. We thought get out there, have enough time to absorb it, to understand it, build the confidence of the former Cianna now Merit, sales force. And yet with all of that, and through the transition, and through all of those things that go on in those in these situations, we were able to come slightly above where we had expected. So I think there's a lot of momentum there. There were no large single customers or anything like that. It was just little guts hardball, selling and executing. So, I mean, I think that's probably the best, but I guess the bottom line is. It is probably a good of a transaction and transition that we have done. I think maybe the best one. I mean, we've done a lot of small deals. But I think that speaks volumes to Joe Anderson and her team and just the way that our team has worked. We kept all the R&D people, we kept the sales people, we've done I think, if they fit into the family actually quite easily. I've been down there several times. I'm getting hit down there again soon. So I think all in all, it was a transaction and a business that I don't know how you could do it any better. To be honest with you, I think we've done it well, and then we have new products and we have new projects underway. So, we're very excited about Cianna and what it means.

Thanks and moving to the balance sheet or cash flow. Could you provide any detail on kind of what free cash flow generation was in the quarter and kind of how that looks to the rest of the year? I know, it looks like your net operating cycle kind of links into bit within the quarter and wondering, if there are any one time occurrence and that led to this? And more or less in general kind of what initiatives you really have planned to kind of improve cash conversion going forward to the rest of the year?

Yes, so free cash flow was negative $4.8 million. We had some building closing in Maastricht. We had some -- our building across the street here in South Jordan, we had some equipment down in Mexico for the BD stuff. So, it was expected and it was budgeted. We did give guidance on CapEx in the summer in the 60 to 65 range. So, we are working on free cash flow, something we're paying attention to. The problem that we run into is, if we step back a little bit, if you look where our growth is coming from. I guess maybe just breaking free cash flow up and you think that some of the big drivers, specifically around working capital. You've got AP, AR and inventory. So accounts payable, obviously, we could go out and try to negotiate longer term with our customers. If you do that, they're going to ask for typically a higher cost because you're financing the inventory. Well, that hurts us in the gross margin. So, we don't really want to do that. We've got to really play it safe there. On the receivable side, our growth is coming from the U.S. They have longer terms out there. That's just historically what's going on there? That's the cost of doing business in Europe. So trying to manage that is hard also. Inventory, I think we can make some, we can make a little bit, we can improve that a little bit and we've got a new inventory policy that we're working on and we're trying to improve that. So I think there's a little bit we can do. We are keeping an eye on the free cash flow. We know it's important to people, but we've got, we're long term planners and so to kind of turn on a dime, when it's an area of increased focus it's hard for us specifically given the planning that we've done.

And I think a couple other things, let me just add some more color, as Raul addressed it a bit, but we've discussed this. We have a new 135,000 square foot facility that's under construction in Salt Lake City. And growth has its cost and a lot of benefits, but you have to invest to have to capacity into the future. As we look down the road, we've talked about this about what we look as our growth this year and next year, but we look well beyond that. And as we look at those things we say these are the capacity issues. That also includes Richmond, where we are now. I think the number was thrown out to me today that somewhere around 50% or 60% of our shipments, run, I hope I'm right on this one, but are now being shipped out of Richmond. So, we've had to put more capacity there to have better service to our customers on the East Coast. We have a facility the same issue in the Netherlands in Maastricht. So, as you can say, we're investing our money in capacity, and in really customer service and leading it to that level. But again, I think we're comfortable with what we said beginning of the year, what we think we'll generate in terms of free cash flow and where we are on CapEx. I don't think anything has changed there. So, we're on task for those commitments we've made early in the year.

And I will point out that we did have $11 million pay down on debt. So, I mean, we're working on that.

Our next question comes from the line of Jayson Bedford of Raymond James. Your question please.

I'll keep it to two. You've mentioned the new MDR initiatives in Europe and the fact that could have impacted. So, that's impacting product approvals in Europe. You mentioned slightly scattered. Are there any other products that have been perhaps delayed from a regulatory standpoint in Europe?

Yes, well, I think, listen, if you take a look Jayson at the whole environment over there. Right now, you've got the Brexit, you've got MDR, and then you've got -- the MDR consolidation, I'll call it, notified bodies. I mean, they're just simply are not the number of bodies. And by the way, I actually believe in the long run that that's actually better for the industry. But in the meantime and so everybody catch up whether it'd be our notified body or the other ones that are there. Incidentally, someone told me and again I think this is correct, but somewhere around 80% of all the products that go into Europe, go through a notified body in Great Britain. We start to think about what that means and especially with all this Brexit stuff, it is slowed all of that stuff down. So, I don’t believe that there is anything there that will affect our goals and our forecast. I think that it’s just frustrating sometimes as when you have just the delay and even lack of communication. So, it’s -- all of a sudden, the FDA has become our sweetheart because they’ll talk to us so we can get things done. And the United States very candidly has become the area of preference. So, we will now in many of things go to the U.S. first, we’re pretty listening we'll be go to the with CE market first of all, so I think that’s flip-flop, but nothing that will affect our overall performance as a company.

And then on the cost side, SG&A was a bit higher than we expected and perhaps we miss model that line item. But is there any way to quantify the costs that are unique to SG&A here in this first quarter? I realized you've mentioned, sales meetings, I imagined bring together Cianna is also an increased cost. So I'm just wondering, is there any way to kind of quantify the impact in the first quarter there?

I'm going to let Raul give an answer to that. I mean I think while they’re looking and I think some people point some numbers, they’re having conversation. Let me just say that that you are right, but we also have the vascular insights, so that is the Clarivein as part of that. You have the training for a number of other new products. You had -- a very candidly, we had our President’s Club. You have -- and we did, that’s not just in Europe, but we did it in U.S. we did it in Asia. It’s something that you can look forward to every year because we try to get those things done and out of the way, so we can get about business. So do you have any quality, I mean, do you want to put anything to that in terms of…

Yes, it was about $2 million or $3 million just kind of those expenses.

Okay. So, it’s about $2 million or $3 million of addition expense in that first quarter or I think we were at 37, we reduce it'd like to be somewhere around the 35% range of expenses, so a couple hundred basis points.

Thank you. Our next question comes from Matthew O'Brien of Piper Jaffray. Your line is open. Matthew O’Brien: Just a quick clarification one, Fred, upfront. Are you saying that SCOUT is going to be delayed a little bit in Europe pass the Q2 timeframe that you provided earlier this year?

No, I'm not saying that. I'm just, you know, we’re not expecting that. We expect that it’ll be in the second quarter or so. Matthew O’Brien: And then, Raul, just on the gross margin side, big step up here in Q1 great to see. But I think for the rest of the year in order to get to the midpoint of the range, you have to average about 51.6% on the gross margin line to get to the midpoint of range that you provided. So, first of all, are you comfortable with that? And then, if so, can you just give us a sense of where some of that improvement comes from here in the last three quarters?

Yes, I think, if you look at the cadence that we had last year, Matt. I think it’s going to follow a similar path. We expect pretty strong gross margin improvement in Q2 and Q3, and then typically, we tend to kind of level off a little bit in Q4 or to be slightly better. So, I think we feel comfortable with it and we'll see a need to adjust that.

And then last one from me. And Fred, I love asking you about the products and previous products, but I haven't heard much on the PAE side in the last few quarters. So just hope you give an update there? And then also same question goes for WRAPSODY and how the development of our product proceeding?

Let me go to PAE, it's always a really hard one. You'll recall Matt that, when you look PAE, you really use small amounts of embolics, you'll use may be one vial where the UFP would average somewhere between 3 and 5 maybe we'd say 4. So, there is a big difference in terms of utilization there for PAE. The other thing is that, you see on a number of products and PAE and I think as we were going and talking a little bit earlier about the products to compete with Terumo. And we say this, we look at that area that area was up 44% on constant currency. Those products, many of those like the ninja, the radial approach to that wires, the hydrophilic, many of those the same products that feed into PAE. So, it's always hard because just nature of the procedure and how it's broken down. But we are still doing training classes on it, we got back from sure that still I think in area that interventional radiologists feel like they can compete that they have a unique skill set that others can't interfere with because of their knowledge of imaging. So, I think that it still high on our priority just to make we have more classes come up. Do you want to comment on that?

Sure. I think, Fred, you've pretty much let it out. I would point the key products like SwiftNINJA in the United States I think grew an excess of 30%. The accessories and the pair procedural products used in the PAE procedure continued to be a significant growth factor for us, but it's an area I think had continued developments. As Fred mentioned, the interventional radiologist continued to put heavy focus on it. And as such, we continued to address it with not only our embolic products but all the other products that are experiencing substantial and significant growth.

So, I don't think you should read into a lack of optimization. I think we try to hit point like acquisitions you're making through Becton Dickinson and those sorts of things. Now, let me come to the WRAPSODY, we are doing a study on in Europe and we now I think have done, I think it's close to 10 patients give or take and our plan is to do 30. We should be bringing on two more locations, one in Scotland and one in Greece, and we believe that those two will be on -- we still believe and I'm looking over my regulatory officer, but I believe. John, do you still believe that we are going to be wrap up that safety study by let's say June or by July.

Give or take, let's say maybe a little longer than that.

Okay. Though I mean, we believe that sometime in the second early, third quarter will have that safety study, we'll then take a look at filing IDE in the United States and that process will start. So, I think the good news is that, all of those cases have been very successful. In the comments, I get positions as well. I will start and I will change over to use this because of some of its features and benefits and deployment over other products. So, again, those numbers are also as we look at that, none of that is in our forecast of course. We only forecast products that have been launched. And all these other things and what we see and what gave us confidence is, we look down the road when we gave our ’19 and our ‘20 year full year guidance.

Our next question comes from the line of Mike Matson of Needham & Company. Your line is open.

Hi, Fred and Raul, it's David Saxon on for Mike. Thanks for taking the questions. I guess I’ll start with one on Cianna. Just wondering, if there are any opportunities to either develop or acquire additional products for those reps to sell?

Yes, I mean, I think the answer is, yes. Going to a comment that we make quite regularly that there's no less than five different opportunities on the table at any given time, and probably another five in the queue opportunities. We believe that the healthcare market is so consolidating. We like women's health, we like a lot. I personally, as I think I've mentioned previously have been in a number of cases. There's a big meeting coming up in Dallas in a couple of weeks. I'll be there. So, we still believe this is an area of a lot of interest to our company. And very candidly, I think an area that needs to have interest. I think there is a lot of room for improvement and a lot of opportunity in women's health.

And how's the business in China performing? And can you talk about your strategy in other emerging markets, like Southeast Asia and Latin America?

Well, I thought no one would ever ask. You know, if you will recall that maybe six months ago when all of the political rhetoric was filing going past and forward that, that's all anybody can talk about, if you have exposure. Our business continues to grow at 20% or better, at a higher level in Southeast Asia, particularly as we look at Malaysia, Indonesia, Singapore, Vietnam, Thailand. Joe Wright, you're in the room with me, he oversees all that. Joe, would you like to comment?

Yes, the business continues to be very strong in China. We continue to get solid penetration in interventional radiology as we're busy expanding into the Southeast Asian countries.

Yes. So, the expansion plans are online. We're seeing really nice improvements, particularly products like the ideal in Canada, Zealand and in Australia. So I mean, our business plan we're much more aggressive and interesting enough, something that a country that no one talks about, other than in news and as it pertains to immigration issues in Mexico. So, we've opened up over the process of opening our first sales office in Mexico City. So, we think that there's a lot of opportunity there. And Joe overseas, Central and South America as well and we continue to see growth. So, I mean, I don't want anybody to be bored. But it's, you know, someone said to me, well, the thing about you guys is just like, tick, tick, tick, tick it's just kind of like doing things all the time and the answers, we're just executing our business plans. I do believe and I said it maybe a couple of times on this call today that there were a couple of things out there. I'm feeling a very nice breeze at my back and I do believe that there are some things out that they could put that into maybe a 10 to 15 knot wind. That's not meant to mean 10% to 15% or any other type of growth numbers. I want to clarify that because I want to make sure as soon as I said that, actually said that, but is that what I mean by that is I'm feeling not a breeze, but I believe that breeze is going to get a little bit stronger and I'm starting to feel it. Raul, do you want to add to that?

I think you would say very robust and I would say robust.

Okay, yes. Okay, there you go. Raul says robust and I say very robust. Be careful of what Raul says, if he says very robust sometime that I'm going to start to worry about it, but the business is very robust.

Our next question comes from Bruce Nudell of SunTrust Robinson. Your question please.

This is Stan Fediuk line for Bruce Nudell. Thank you for taking my question. Just a quick one on your Catheter segment, came in better than we expected. I was just wondering, if there any one-time items embedded in the quarter?

I'm looking at, at Raul and then I am Justin and Joe, and we don't see any one-time events there. Just kind of that part of that breeze I was talking about.

Thank you. At this time, I'd like to turn the call back over any closing remarks.

Well, first of all, we try to keep this. I know there are other calls going on today and we try to keep this as tight as we could and as formative as you can. Listen, we'll be here for the next couple of hours. We appreciate your interest in the Company and we'll look forward to talking to you. Thank you very much and signing off from Salt Lake City, wishing you a very good evening. Good night.

Ladies and gentlemen, this concludes today's conference. Thank you for your participation. You may disconnect your lines at this time. Have a wonderful day.