Earnings Labs

Trinity Biotech plc (TRIB)

Q4 2015 Earnings Call· Thu, Mar 3, 2016

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Transcript

Operator

Operator

Good morning and welcome to the Trinity Biotech Fourth Quarter and Fiscal Year 2015 Financial Results Conference Call. All participants will be in listen only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Joe Diaz at Lytham Partners. Please go ahead.

Joe Diaz

Analyst

Thank you, Gary, and thank all of you for joining us to review the financial results of Trinity Biotech for the fourth quarter and full year 2015, which ended on December 31, 2015. With us on the call representing the Company are Ronan O’Caoimh, Chief Executive Officer; Kevin Tansley, Chief Financial Officer; and Dr. Jim Walsh, Business Development Director. At the conclusion of today’s prepared remarks, we will open the call for question-and-answer session. Before we begin with today’s prepared remarks, we submit for the record the following statement. Statements made by the management team of Trinity Biotech during the course of this conference call that are not historical facts are considered to be forward-looking statements subject to risks and uncertainties. The Private Securities Litigation Reform Act of 1995 provides a Safe Harbor for such forward-looking statements. The words believe, expect, anticipate, estimate, will, and other similar statements of expectation identify forward-looking statements. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development, commercialization and technological difficulties and other risks detailed in the company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements reflect management’s analysis only as of today. The Company undertakes no obligation to publicly release the results of any revision to these forward-looking statements. With that said, let me turn the call over to Kevin Tansley, Chief Financial Officer, for a review of the results. After Kevin’s remarks, we will hear from Jim Walsh, on product development issues and Ronan O’Caoimh, will wrap up the prepared remarks with his perspectives on the quarter and the year. Kevin?

Kevin Tansley

Analyst

Thanks very much, Joe. Firstly, today I’ll take you through the results for quarter four and then the results for the full-year 2015, so beginning with quarter four. Total our revenues were $24.9 million and this compares to $26.7 million in quarter four of 2014. As we’ve mentioned in the release, some impacts are driving this, it’s been the impact of exchange rate movements, in fact it would also have an impact on other aspects of profitability as I will mention later on. Ronan will provide more details on the revenues for the quarter later in the call so I will now move on and discuss the other aspects of the income statement. Growth margin for the quarter was 43.2% and this compares to 47.5% in quarter four 2014. This is one of the places where we are seeing the impact of the exchange rate movements. In fact this year for the previous three quarters you would have seen that our gross margins have been approximately 2% lower than in the previous year, while you can see that reduction this quarter is somewhat more pronounced. This is due to the fact that part of our year-end financial close perhaps we have changed the classification of certain costs within the income statement to ensure consistency across the group. The amounts in question are not large, but as they relate to the year as a whole, they have a disproportionate impact on quarter four as results. The impact on cost of sales to this factor [ph] example is approximately $500,000 and which equates to approximately 2% on gross margin and thus, this the explains the lower than expected margin this quarter. Given we’re only talking about reclassification of costs, the same factor has impacted elsewhere in the income statement and in this…

Jim Walsh

Analyst

Thank you, Kevin. I’ll take the opportunity now to update you on our cardiac development programs. In particularly I’ll provide you with a detailed update on our Troponin FDA submission and an overview of our clinical trial data. I’ll also provide a brief update on our Meritas BNP product, which as you know is currently undergoing clinical trials to support the 510(k) and FDA application. Starting with Troponin, you know of course that on December 17 last we submitted a 510(k) application to the FDA for a high sensitive division product. This was the culmination of many months of clinical trial work in United States. To the very best of our knowledge Meritas, is the very first point of care Troponin product ever to be submitted to the FDA under the new guidelines adopted in accordance with the third definition of MI. It is very important to keep this fact in mind later as it will compare our clinical performance in some of the currently approved market leading Troponin products. As the complexity in terms of the new guidelines has lays on clinical performance by many orders of magnitude. The guide line change of course has made the clinical trial very challenging for Trinity, however in the long run it may prove to be a huge advantage to us, as it provides a similar high barrier to our competitors. Following our December submission, the FDA contact does on December 23rd to confirm they had received our application and that they issued - our application with a file number or a KA number at this morning in our industry. We were again contacted in writing by the FDA on January 5th with a number of relatively minor clarification questions. We submitted our response to this questions one week later and shortly…

Operator

Operator

[Operator Instructions] The first question comes from Larry Solow with CJS Securities. Please go ahead.

Larry Solow

Analyst

Just clarifications on the Meritas first, so it sounds like I guess, your best guess is you’ll hear something from the FDA by the end of April. Then more than likely it will be more questions and then that will sort of trigger another 90 day clock after your respond to that, is that sort of where you stand today?

Jim Walsh

Analyst

Larry, hi, Jim here. Correct, Larry, okay, so, we may hear before the end of April, historically the tentative for 90 days okay. Having said that we have submitted multiple 510(k)s for the FDA over the years and we have never had the same amount of communication back and forth, that we’ve had on this particular product, so there is no doubt they’re taking this particular product very, very seriously. But yes, we would expect that wasn’t a first - we may get some clarification questions within our [indiscernible] but I would suspect that they will take their full 90 days and come back with all sorts of suggestions and et cetera, et cetera, et cetera. So that may involve having to perhaps even add one or two more patients to the cohort, God knows what Larry. But I would expect, in an ideal world, obviously, they would go back and say, its approved at the day, but I think that’s highly unlikely. It’s possible they’re going to ask us to do some work that would have need to be done through augment the data set. It will take some time to do that and then theoretically you will submit that and another 90 day clock would start again. It’s not impossible for that to happen more than once. So best guess is, we get questions back in April, we’ll answer them, we’ll submit them to take over 90 days. And perhaps if we get approval, but it wouldn’t be beyond the - of that happening, okay.

Larry Solow

Analyst

Got it. Got you. Okay, and then just on the Meritas, could you just talk about just underlying spending or the increase in spending in ‘15. A little bit hard to obviously gauge because I know SG&A is impacted by currency, getting the reclassification this quarter. But just a look at first sort of what spending was on Meritas in ‘15 versus ‘14? And do you expect that to go up in ‘16 before the approval or how you look at that would be great. Thanks.

Kevin Tansley

Analyst

So last year I think we would have announced that we would have spent $2.3 million in relation to sales and marketing related Meritas cost. And we would have been increasing steadily our expenditure throughout the year starting at about $600,000 in quarter one to close to $3 million for the year in the P&L on that. As volume goes forward obviously the next key thing to happen to us it will be getting approval as we approach, getting an approval we would possibly looked for additional cost in place and just in terms of strengthening our sales force in the U.S. with specialists et cetera. So you can’t expect it to go up as you can imagine prior to a launch and then the other non-personnel costs as well as you would expect, markets or et cetera and gauging key opinion leaders and what have you.

Larry Solow

Analyst

Okay. But does it necessarily need to do up. I mean, I assume it will go up, not by the high cost problem, hopefully that you will face. So that need to go up dramatically or it seems like you’ve been sort of increasing investment.

Kevin Tansley

Analyst

No, I don’t see it going up dramatically prelaunch obviously, as the product is launched and it gains traction and obviously additional personnel will be required to make sense and I wouldn’t - nothing like in a linear basis what you are talking about developing a very significant cardiac franchise which is what we’re about. And you’ll have to have people involved in servicing and there will be increased shipping people et cetera. So basically I think as you refer to there, it will be high quality problem in that particular juncture.

Larry Solow

Analyst

Right. Okay. And how about just any progress on outside the U.S. trying to get opinion leaders more on board and doing other exploratory work and I guess their own independent trials or how is that effort shaping up or is there any movement, any progress there?

Jim Walsh

Analyst

Jim again. The answer is absolutely yes, okay, but, we put really all our efforts for 2015 and focus on getting our clinical trials in United States to complete and manage, okay because even though Kevin says we have a big spend here, we’re a very small team and a very focused team. So we put all - virtually all efforts in United States. But for instance, we have registrations in Brazil, which can be a very big market for us okay and we have started clinical evaluations in Brazil. We have started registrations in China, although China is a long process. Those registrations are taking place. As we speak, we are as well as getting together again with some of the European countries and recently starting the evaluations that we would have commenced before we had product problems in 2000 and later as ‘2014. So yes, is the answer but it’s really only starting now.

Larry Solow

Analyst

Got you, okay. Gross margin, switching gears a little bit, excluding the recharacterization or classification, I guess that this gross margin is being hurt by currency and still a little bit on the Premier side. How do you guys view that going forward? I’m assuming currencies sort of stabilizes and where do you see that gross margin going?

Kevin Tansley

Analyst

Yeah, as we look at the difference of margin year-on-year, you’re talking 48%, 46.2% or 1.8%. The majority of that is currency, as a small element, which relates to sort of more unfavorable sales mix and a lower lying sales has been our margin product for us, that doesn’t help things certainly. We had lower HIV cells obviously, in particular in quarter two, it wouldn’t have helped us in that regard. But the big factor there is currency. I would ignore the lower quarter or this quarter. So just to make that point of currency there, or it stays the same, you can expect, that wouldn’t deteriorate any further. Obviously, it depends on the sales mix and revenue levels going forward. We are fortunate that if and when our revenues do begin to grow, we will have a leverage effect whereby our fixed cost will be spread over a wider base and hence you get the operating synergies that we’re looking for. So from that point of view improvements will come as also as you mentioned there, in relation to Premier as you get more and more in the field and you’re just getting the throughput books from the reagents associated with that, so that will also help.

Larry Solow

Analyst

Okay, and just lastly on Premier, clearly a majority of the year-over-year drop Brazil. Although it does seem like there was some other I guess, maybe Turkey some other countries had some drops, right that that sort of from the 450 to the low 300s. If you could comment on that. Comment on what you see actual reagent, utilization and reagent sales and without giving a number do you see placements returning to growth in ‘16 or only stabilizing. Thanks.

Kevin Tansley

Analyst

On Premier?

Larry Solow

Analyst

Yeah.

Kevin Tansley

Analyst

And I think well, we did 460 instruments in 2014, we did just over 350 in 2015 --

Larry Solow

Analyst

Over, 3-5-0, 350 or 300?

Kevin Tansley

Analyst

350, okay I think you said it was - okay, 350, okay, so it was basically all Brazil.

Kevin Tansley

Analyst

Yeah, so it’s all Brazil, so it really depends on what stage we get back into Brazil and what that depends on is how quickly we can get up manufacturing in a significant way. And when because at the point, which we do we’ll get Q3 savings, as we bring product in. As we bring raw materials and we also get an overall savings on VAT on sales tax on our entire business. And so we get to natural hedge on savings there. In addition to that, we are looking for price increases. As an example, we had no choice in giving 12% as salary increases to all of our visiting employees. I mean, that reflects the inflationary environment that’s sound there. So I think the combination of the cost savings and the price increases will enable us to get back in. But it’s just a result of time where depends on government licensees for manufacturing et cetera. So I think it’s going to be kind of late 2016, late this year before we really back up and running. Now the point at which we are back up and running, our sales was - our placements will recover significantly. We’ll confident that there’s significant demand for our product. So I think at stage, we all to get back to sort of 400 to be 400 in front of the number, like 400 and something probably very low 400, I think it’s fair. I think you will probably see us maturing.

Larry Solow

Analyst

Okay, then just lastly on the share repurchases, do you guys plan on - do you have any target. I know you can purchase up to a certain amount, but do you --

Kevin Tansley

Analyst

Yeah, I mean, we can’t give you anything exact as you can imagine.

Larry Solow

Analyst

Right. Absolutely.

Kevin Tansley

Analyst

There are number of factors, I mean it depends on liquidity of the stock, it depend also on the share price at the time, general market conditions, all of which is somewhat unpredictable project. But there are specific rules that we have to adhere to and we should determine, how much we can in a particular day and et cetera. et cetera. Just in terms of our authorization. Our most recent annual general meeting authorizes us to purchase 10% of our shares, which would be 2.3 million shares and we have that authority. In terms of how quickly we move. We will move fairly immediately. We would be - into the markets and as soon as we’re allowed which is in the next few years.

Operator

Operator

The next question comes from Jim Sidoti with Sidoti and Company. Please go ahead.

Jim Sidoti

Analyst · Sidoti and Company. Please go ahead.

Good afternoon, can you hear me?

Jim Walsh

Analyst · Sidoti and Company. Please go ahead.

Hi, Jim, how are you?

Jim Sidoti

Analyst · Sidoti and Company. Please go ahead.

Well. Would you say that the sales levels in Brazil, in Russia and some of the other regions where you’ve had a pretty big headwind of currency. Have those bottomed out as this point or do you think they could decline further from where they were in the fourth quarter.

Kevin Tansley

Analyst · Sidoti and Company. Please go ahead.

Well, let me, Ronan, obviously mentioned the fact as Russia has gone from over 1 million - about 100,000, so I think it’s fair to say that as bottomed out regardless of what happens in the future currency wise. We’re obviously, hopefully, that the Brazilian currency was stabilize, if not actually improve going forward. It has hovered around the sort of the high 3s, low 4s. So we’re hopeful that has ended, it’s not the [indiscernible] that as well as that in around 2, so we are hopeful it would come back towards those level. Now if doesn’t happen, we would hope as I say, inflationary pressures in the market would help things. We’re already seeing that and again, the level of salary increases points to that. So today, we’re sitting at 3.82 and if things stay like that we would expect that the combination of inflationary pressures in market plus that the measures that we are taking will help us in that regard.

Jim Sidoti

Analyst · Sidoti and Company. Please go ahead.

Right. And then on a similar note, the Lyme disease sales, those were down because of the severe winter in ‘14. Do you think those are at a level where they’ve bottomed out do you think those could decline further in 2016? Ronan O’Caoimh: Jim, Ronan, here. I think - this a mild winter, relatively mild winter, so I think all is well for coming year.

Jim Sidoti

Analyst · Sidoti and Company. Please go ahead.

Okay, right and then in December the Congress put a two-year suspension on the medical device tax. What impact will that have for you in 2016?

A - Ronan

Analyst · Sidoti and Company. Please go ahead.

Yeah, that was very welcome good news and to be very exact about it, we were $632,000 to assess, I think last year, to give you a very exact answer. So it’s a very welcome news. We’re very pleased about that.

Jim Sidoti

Analyst · Sidoti and Company. Please go ahead.

All right. And then my last question is, will you have any communication with us regarding Troponin prior to the next quarter, if you do get questions from the FDA. Will you come back and let us know right away or is it something you would wait until the next quarterly conference call to tell?

A - Ronan

Analyst · Sidoti and Company. Please go ahead.

I think I don’t believe we would sort of call a special conference call to deal with it, I don’t believe we would. I mean, the circumstances are ironically that the two banks should probably coincide very close to each other. I don’t if I kind of open, but let’s imagine that our quarter one results would be sort of say 23rd of April something around there. They’re actually due back around that sort of. Maybe they could come back by 28. Our sense is they will come back before, so we’re kind of they might come back sooner. You would noticed, when Jim was giving the outline, it’s certainly unprecedented in our experience and we’ve done over 150, 510(k). It’s unprecedented to have sort of the FDA answering on the 5th of January and then on the 3 February, the 5th of February, the 12th of February. So you know, who know when they will be back, but I think the chances are that the two events will largely coincide and we will be able to give you a good update on the next quarter.

Jim Walsh

Analyst · Sidoti and Company. Please go ahead.

I think we should say Jim, here that we need to be very careful that, in discussing the FDA on these calls that we don’t any impact will be seen back into the FDA when it corners if you like, okay. That can only come against you, you know what I mean, so you really have to stay there. The FDA will prefer that you would not absolutely to have any discussions with the company publicly, so we have to be very carefully that we don’t irritate them. I mean, you have noted for example, that when we announced our submission to the FDA, it wasn’t very expansive, it little one paragraph. And no commentary I don’t think it like that, so that is the kind of way we would probably approach it.

Kevin Tansley

Analyst · Sidoti and Company. Please go ahead.

So we may not hear anything regarding the trial or regarding the FDA in Troponin until approximately it’s approved.

Jim Walsh

Analyst · Sidoti and Company. Please go ahead.

Well, no, I’m not saying that, but I’m simply saying that, we’re saying that, walk a fine path, and we just have to be careful not to do anything that would hurt the chances to bring the product, through the process.

Jim Sidoti

Analyst · Sidoti and Company. Please go ahead.

That’s fine. All right. Thank you.

Operator

Operator

The next question comes from Drew Jones, Stephens Inc.

Drew Jones

Analyst

First question on Troponin and I guess, Jim given some of the sensitivity of what you just discussed. But you talked about the sensitivity on type 1, it’s 75% assuming approval, is that something that would go on the label or that you could put in marketing materials?

Jim Walsh

Analyst

That would absolutely has to be negotiation with the FDA. My gut feels it’s highly unlikely because we work enough by the FDA to select to do a trial on type 1s and type 2s so we’re actually we’ll do a trial on all-comers, which would include type 1s and type 2s, so I’d be very, very doubtful we get through that quite frankly. But I can, absolutely what we will do of course. So I think we’re going to eventually work on that trade, but what we will do is we will run a number of what you might call side papers, okay, with the key opinions leaders, the likes of Red Apples [ph] the like of we have all the key opinion leaders working with us on that. So we can get them to run specific trials for us, like on type 1s, like on type 2s and we can publish separately. But I think it’s unlikely you’ve get to make that same. Just by the way we were asked to set up the trial.

Kevin Tansley

Analyst

So I was just going to say that 65% sensitivity, that includes both type 1 and type 2s is very powerful and that event, so its way ahead of the competition.

Drew Jones

Analyst

Okay. Yes, sure. Not trying to discount that at all. But I guess moving over to diabetes, if you exclude any assumption for Brazil, is that a business that will grow in 2016? Ronan O’Caoimh: Absolutely. Because you need to bear in mind, I think I mentioned this in my prepared comments is that every instrument, every Premier that we place is new addition of business. Everything, so we’re not replacing existing products that we have in the market. So it’s all new business, it’s all growth.

Drew Jones

Analyst

And then last one from me, you kind of referenced it in the press release, but is it safe to assume no M&A activity this year? Ronan O’Caoimh: No, that would be actually very erroneous, no we are continuing to look for acquisitions either singular or plural and actively seeking to do so. I mean, a buyback and an acquisition aren’t mutually exclusive events. One thing is the reason that we haven’t and done a deal over the past number of months is because not because we couldn’t find anything that we liked, we did, but because price expectations were entirely unreasonable. I mean, I think we are all aware of the fact that, valuations and prices are not et cetera are coming down and some smaller companies are running out of money, can’t fund and so we think that more opportunities may arise. Certainly that we’re expecting price expectations now to soften to become more realistic. I can’t say that we’ve seen much strong evidence of it today. But I think it’s - we’re hoping that it will be an evitable consequence of what’s happening in markets.

Drew Jones

Analyst

Thanks guys. Ronan O’Caoimh: Thank you.

Operator

Operator

The next question comes from Per Ostlund with Craig-Hallum Capital. Please go ahead.

Per Ostlund

Analyst · Craig-Hallum Capital. Please go ahead.

Thanks good afternoon guys. I guess, following up to both Drew and Larry’s questions on the Premier side. Just want to kind of through the 6% growth here in the fourth quarter. Is it safe to assume that the consumable pull through is running north of that 6% given the placement difficulties in Brazil. And then I guess just in general how satisfied are you with where the reagent pull through per instrument is at this point.

Kevin Tansley

Analyst · Craig-Hallum Capital. Please go ahead.

Yeah, we’re very satisfied with the reagent pull through in Brazil, in the United States, particularly in Europe and but less so in China. I think we’ve shared that with you in the past. We’re replacing 100 instruments a year into China like clockwork, 25 instruments every quarter and that’s a good news. The disappointing news is is that the reagent run rate on those instruments is modest, okay. But the part of this is that its growing. So you have a situation where you got progressively more and more reimbursement across more and more Chinese districts. But the GP, the doctor on the ground needs to the attuned to it, basically be sending his patients - to send his patients samples and that’s growing, so we expect to see that grow. But in terms of unit items they’re disappointing in China. Elsewhere they’re extremely positive. Does that answer the question.

Per Ostlund

Analyst · Craig-Hallum Capital. Please go ahead.

It does answer the question. Thank you. Turning to the cardiac side, I guess really quickly and thank you for really all the color on Troponin in the ongoing dialog there. I guess that the question that I would have maybe as an adjunct to that on the BNP side. Assuming all goes well with Troponin, assuming all goes well with BNP, are the two approvals still kind of looked at as being an relative concert time wise, I know that’s been sort articulated in the past that maybe de-advantageous to have the tow in the market together. Just want to see if that timeline is still kind of on target.

Jim Walsh

Analyst · Craig-Hallum Capital. Please go ahead.

Well, first of all, it’s clear from what I just said on the advice of the FDA we did have to expand the number of trials for BNP quite dramatically. We have planned to four trials sites and they did very much suggest that we should expand that to 12, okay. That has slowed us down, I’d say we had lost a quarter on BNP. We’re recruiting, so just to give you the detail, so we held a several of the patients recruited and we’re recruiting probably about 16 or 17 across the 10 sites, okay. That will get us a complete data set by eight weeks or now, okay. It’s not nearly as difficult a trial as Troponin, it’s one patient, one sample, none of this four time points et cetera, so it’s a much less intense I suppose clinical trial and a much smaller application in terms of just volume it should - there’s a good chance that some of this more surprisingly clinical data and that this may have a chance of going through one cycle with the FDA i.e., submission some questions and a return within 90 days, at worse 180 days. So yes, I think there is a fighting chance of there or thereabouts to get them.

Per Ostlund

Analyst · Craig-Hallum Capital. Please go ahead.

Very good. Thank you. And then I guess my last question is just purely housekeeping for Kevin. In the last couple of releases I think, you’d sort of broken out a table of what sort of the net financing income items were related to the exchangeable notes, sort of internal cash, non-cash expense income, would you be able to provide that now or is that a follow-up question for later? Thank you.

Kevin Tansley

Analyst · Craig-Hallum Capital. Please go ahead.

I can go through it with you in more depth, but what you’re seeing is you’re talking about the quarter or for the year?

Per Ostlund

Analyst · Craig-Hallum Capital. Please go ahead.

The quarter?

Kevin Tansley

Analyst · Craig-Hallum Capital. Please go ahead.

So for the quarter, if you’re looking at financial expenses there, the $1.2 million virtually all of that is the standard cash base interest, the 1.15 million is what you’d expect, 4.6 million being the annual cash interest, so divided that by four, is 1.15. Included in the 975,000 that of non cash financial income there is a gain of 1.15 million which is coincidentally the exact same number as the cash base interest or gain of 1.15 million of non-cash gain in relation to a revaluation of embedded derivatives and that is offset by 175,000 off noncash interest charges, which is just the accretion required to bring the nominal amount as a loan back upto - the carrying amount loan back the phenomenal amount of loan at the very end of its life. So does that answer your question?

Per Ostlund

Analyst · Craig-Hallum Capital. Please go ahead.

I think it does. Thank you. I appreciate it.

Operator

Operator

The next question comes from Chris Lewis with Roth Capital Partners. Please go ahead.

Chris Lewis

Analyst · Roth Capital Partners. Please go ahead.

Hi guys, thanks for taking the questions. Want to start on Troponin following up on a couple of -- earlier questions. Jim, you talked about potentially a possibility to add more patients or need to add more patient to the cohort to respond to some potential FDA comments or questions. Can you elaborate on that -- at their initial comments at you made --?

Jim Walsh

Analyst · Roth Capital Partners. Please go ahead.

I’m not expecting that to happen quite frankly at all. If you think actually we have over the number of patients than the FDA actually asked us to do. I will just give you that as an example of - in the past in certain other 510(k)s they would have asked you to add elderly patients over the age of 80 years and they are not expecting that at all in this particular, because I just can’t anticipate what the questions will be. But I do anticipate it there will be some of our work to be done, maybe I’m wrong, but it’s just unknown, but certainly I’m not expecting that, put it that way.

Chris Lewis

Analyst · Roth Capital Partners. Please go ahead.

Okay, so to be clear there, nothing from there I guess comments are absolutely?

Jim Walsh

Analyst · Roth Capital Partners. Please go ahead.

No, absolutely not. Not at all. If I lead anybody to that conclusion please that’s not the case. All of our comments today have been actually very much administrative type things. There has been actually no question at all on the data of any shape or size okay.

Chris Lewis

Analyst · Roth Capital Partners. Please go ahead.

Great. Appreciate it. And on that 65-ish percent sensitivity in the US trial seems to be a bit lower than the Doctor Apple study more sure about sensitivity of 75%. I guess first is that observation correct and then can you elaborate I think and maybe due to the blood versus plasma and the mix of patient and types of samples but can you just elaborate on the delta there and how the FDA will look at you know both of those data sets?

Jim Walsh

Analyst · Roth Capital Partners. Please go ahead.

Well, first of all just to say the FDA, Dr. Apples data set has nothing got to do with the FDA okay, that was just a separate trial that was done, that we had actually asked to be done before, we embarked upon the U.S. clinical trials just to make sure that our product was as good as we thought it was, okay. But essentially the difference - there are couple of differences in the Dr. Apple trial to the FDA trial, okay. In Dr. Apples trial you got 75% sensitivity and whereas in our FDA trial we got 66% sensitivity, okay. Couple of differences, first of all, Apple samples were bank samples so working fresh samples, okay, they were bank samples, different people over a period of two or three years and because they were banked the vast majority of working hold blood they were because you can’t all blood, if you like okay, it has to be turned it into plasma, and actually if you look at the data that we got from our plasma results in the USA you will see that we actually got 78% sensitivity on plasma in our U.S. trials. So that’s one thing, so there’s a difference of sample made between plasma and whole blood. So our 78% is very close to spread out with 75%. The second thing, is that in the Apple data, I don’t know the percentage to mind as a normal, but he had a much less type 2 MIs in his cohort, than we had in - I think it is by 10 or 12% type 2 MIs in this cohort than we had our 43% MIs in our clinical trial cohort, that again will serve to explain the differences in the data. But quite frankly, that not an issue for the FDA because the FDA have no interest quite frankly in the Apple data because that was just a separate independence it had done, and nothing to do with the FDA trial.

Chris Lewis

Analyst · Roth Capital Partners. Please go ahead.

Okay, I appreciate all the color there. In the past you’d outlined a point-of-care Troponin marketed about $350 million. You have the kind of the latest testimony, how that’s splits up between the U.S. and Rest of World.

Kevin Tansley

Analyst · Roth Capital Partners. Please go ahead.

Yeah, we estimate that 80% of the market is in the USA, let’s say 280 million in the USA, 70 million in the rest of the world, so it’s primarily a U.S. market and that’s the way we’ve approached it, our primary effort has been in United States. Thereafter, we’re working in Brazil, we think Brazil is 15 million, China is about 20 million. Europe really quite modest, has happened there yet. It’s going to be a missionary sell. So and then in terms of the 280, we would give about not far off 50% that to Apple i-STAT 25% to lira’s triad [ph] and then the balance would be to. The balance we call basically point-of-care but it’s actually big instrument that one quickly. So there’s radiometer instrument and Mitsubishi pathfinder, so those three would share that other 70 million in United States. Arguably they’re Central Lab because it’s kind of $50,000 instrument that you can place into the small room office that can run in 15 minutes. So it does the test quickly, but it needs an operator. So arguably it’s hybrid, so does that answer that question.

Chris Lewis

Analyst · Roth Capital Partners. Please go ahead.

Yes, it’s very helpful, thanks. And then my final question is just about kind of the growth outlook for this year. I know you don’t give official guidance, you have quite a bit in moving parts, I appreciate all the color you provided in your prepared remarks, within the different sector, drivers and segments of the business. But bigger picture excluding more significant FX pressure this year, do you see the Company getting back to positive revenue growth in 2016. And what are the key kind of drivers and how do you prioritize those to get back to the positive revenue growth?

Jim Walsh

Analyst · Roth Capital Partners. Please go ahead.

Yeah, because we absolutely do, but as you said yourself we don’t give guidance. I think what I would say is we talk to yourself and other analysts and we interact with you and you guys have, we’re very grateful to go to and basically put out numbers and I think people who want to get a flavor for where we’re going, I think they’re getting the best flavor that way. I mean, you guys have talked to us but I mean I think all of your research would indicate growth of sort of 5%, 6% in that kind of mark, we’d be comfortable with that kind of level. I think on average, the 6 of your are kind of somewhere between 104 and 107 maybe from recollection. I think one of the analyst has a much higher number. I think Sidoti’s higher number was they have gotten an acquisition built into their model. So as that order of magnitude and I think we’re comfortable with those kinds of numbers. Is that helpful.

Chris Lewis

Analyst · Roth Capital Partners. Please go ahead.

One more in if you don’t mind. Cash financial income for the quarter diluted adjusted EPS was that $0.06 and $0.08, but I believe that was on the basic share count. So on a diluted share count is it about $0.06?

Kevin Tansley

Analyst · Roth Capital Partners. Please go ahead.

You broke up at the start of that there Chris, just you’re talking about the quarter is it and the dilutes.

Chris Lewis

Analyst · Roth Capital Partners. Please go ahead.

Yeah, I was talking about the non-diluted EPS excluding non-cash financial income, I just want to confirm if my math is correct, it’s about $0.06 per share?

Kevin Tansley

Analyst · Roth Capital Partners. Please go ahead.

No because, no dilutive EPS was $0.015 for the quarter, diluted EPS already excludes the noncash financial income, that’s potentially what calculation does, it removes all aspects in relation to the note, so it excludes the cash interest the non-cash interest and the change in fair value of the derivatives. So you don’t have to make a deduction. So you take the profit after-tax, so 2.8 million, you take out the 975,000 of a gain, you’d add back the 1.15 of cash interest which will give you a figure of about 3 million and you divide it by the diluted number of shares, which is 28.7.

Chris Lewis

Analyst · Roth Capital Partners. Please go ahead.

Got you. Okay. Thanks for the clarification.

Operator

Operator

The next question comes from Paul Norrie with Novel Equity Fund. Please go ahead.

Paul Norrie

Analyst · Novel Equity Fund. Please go ahead.

Hey, guys. So, I know it will take some time to ramp up the point-of-care Syphilis business, but you got the CLIA-waived over a year ago now and is it a process the clinics have to go and get the funding for it or is it more that they have to make room in their budget. Ronan O’Caoimh: I think Paul, it’s probably a combination of both and I would concede by the way that the progress we’ve made and its disappointing and as I said quarter one, 10,000, quarter two 100,000, quarter three 300,000, quarter four probably not going to be - just under 400,000, so it’s still progress but we are confident that the market is there. What’s probably not helping is is the CDC, haven’t really engaged in an active way, so for example in the case of HIV they would have written the protocols and kind of agreed with each of the individual states. Now in this case they are kind of inactive and we’re the ones that are having to kind of handhold the state with protocols. As you said it in your question and the holding of funding finding room in the budget and then after that is the whole training process. So it’s just very slow and as I said, our sense is that we can get it to about $10 million business, I guess, it’s a new business, it’s a missionary sales and we have it all to our sales. I don’t see any competitors coming on to the market even on a very long time horizon. Because you don’t have to get an FDA approval and then after that separately get a clear waiver both of which are really difficult hurdles. So our best estimate anyway is that in the longer term we get to $10 million but that is I caution that’s only an estimate that would basically make syphilis market 20% of where HIV has gone because HIV is a $50 million market and we are suggesting that we can bring syphilis, make it to one-fifth of that size. I mean, if anything that percent should also sound conservative. I think it’s very achievable but I will admit that we are a bit taken aback at just how slow the whole thing is kind of coming around.

Paul Norrie

Analyst · Novel Equity Fund. Please go ahead.

Well how many sales people do you have addressing that portion of the market? Ronan O’Caoimh: Well, we have general, so I mean, we don’t have, we have general but we also then have a number of absolute specialists at public health people, so we only have three full time public health specialists, but the number of people who are involved in this process is the entire group of 30 sales people. So with three dedicated and then with 27 general.

Paul Norrie

Analyst · Novel Equity Fund. Please go ahead.

Then the Immco acquisition are there any new products expected this year? Ronan O’Caoimh: Yeah we would have immune directs and lot of product going through the FDA approval process. Yes we will continue to range of products continue to come on to the market but we certainly don’t have any black bottled [ph] that I could say, that I would mention, it’s more kind of broadening of our product, we’re filling out the product range basically as you require to do sort of upto 40 products.

Paul Norrie

Analyst · Novel Equity Fund. Please go ahead.

Okay. And then I think the company spent around $6 million on CapEx in the quarter, is that mainly development cost?

Kevin Tansley

Analyst · Novel Equity Fund. Please go ahead.

Yeah, that 4.7 of that will be on development cost, the 1.3 million on PP&E.

Paul Norrie

Analyst · Novel Equity Fund. Please go ahead.

And well, that relented all in 2016 or will it be about the same place? Ronan O’Caoimh: Obviously, we’ve come through a very high in relation to trial cost and what have you so sales cost from the Troponin side we’ll obviously be eliminated and we’ll be replaced somewhat the BNP trial costs, so they are much lower because they’re much simpler trials process and a smaller per se fewer elements. So swinging around about but basically the reduction showed that way in the increase should it come down this.

Paul Norrie

Analyst · Novel Equity Fund. Please go ahead.

Okay. And then last question, when you’re looking at acquisitions, are you looking at technologies that you could possibly put on your platform? Are you looking at generally stay in the same spaces at year-end? Or are you kind of open to a lot of different things?

Kevin Tansley

Analyst · Novel Equity Fund. Please go ahead.

Well, we’re probably not really looking for a technology acquisition at this time. I mean, I think for example we made a technology acquisition in Sweden, but I think we’re really looking for bricks-and-mortar as solid revenue and earnings enhancing accretive add-ons, that’s really what we’re looking for that will have synergies within the existing organization rather than basically buying technology in which we’d spend further.

Paul Norrie

Analyst · Novel Equity Fund. Please go ahead.

Okay, thanks.

Operator

Operator

The final question comes from Walter Schenker with MAZ Partners. Please go ahead.

Walter Schenker

Analyst

Thank you, as launches do, I’ll be quick. Two related questions both relating to capital allocation. First, is there any technical or legal reason aside from the use of capital? Why the dividend needed to be eliminated in starting up a buyback? And secondly, in regard to the buyback, your goal is to in fact buy the shares as opposed to buying shares over a 12-month period and therefore if some would walk in with a large block tomorrow, hypothetically speaking, I don’t own it, so won’t be me. The million shares tomorrow. End of the week beginning in next sequence starts, you would have and the price was acceptable you can just go buy stock, i.e. you want to by 2.3 million shares. As expeditiously at reasonable prices is possible. Thank you. Ronan O’Caoimh: Okay, Walter Ronan here. Just in terms of there is no legal link between buying back share and paying a dividend just I think you’re kind of asking that. I mean, we are not stopping paying a dividend, we are not obliged to. It was a decision made by the board, I mean, it was made on the basis that we felt that given our size, I think said in the press release our level of R&D expenditure and the stage of the divestment that the company is at, that it just didn’t seem appropriate, that was - it was not there was no legal reason that we couldn’t pay a dividend because we weren’t making any enough profit or anything like that. So with the second part of your question is yeah, I mean in terms of what we can buyback, there are very requirements in terms of you can’t be opening trades, you can’t be closing trades, you can be only 25% I think of the average daily volumes they’re moving whatever so that create quite restrictive. So then sort of in addition to that you can buy blocks if you still wish. So the answer to your question is yes, we might buy blocks, we probably won’t buy blocks.

Walter Schenker

Analyst

Okay, so the goal is to buy in the stock, not necessarily over a time frame, but to own by the Company those shares. Ronan O’Caoimh: Yeah, I mean, again as we’ve said at the outset I mean, everything is variable, it will depend on the price it will depend on the volumes, it will depend all of those factors, but yeah, I mean, we’re very. Our intention is to get into market and buy stock. We think that the price is - we think it’s a very good price to buy the stock.

Walter Schenker

Analyst

Thank you. Ronan O’Caoimh: Thanks Walter and then, okay. So I think we probably set a record today. I’m sorry, it’s 23 minutes past 5 or past 12 in your case, so any way. Thank you for your attention and your support. We look forward to talking to you at the end of quarter one. Thank you and good morning. Bye-bye

Operator

Operator

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.