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Trinity Biotech plc (TRIB)

Q4 2012 Earnings Call· Tue, Mar 5, 2013

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Transcript

Operator

Operator

Good day and welcome to the Trinity Biotech Fourth Quarter and Fiscal Year 2012 Financial Results Conference Call. (Operator Instructions) Please note this event is being recorded. I’d now like to turn the conference over to Mr. Joe Diaz of Lytham Partners. Please go ahead sir.

Joe Diaz

Operator

Thank you, Janice. Thank all of you for joining us to review the financial results of Trinity Biotech for the fourth quarter and the year ended December 31, 2012. As the operator indicated, my name is Joe Diaz. I’m with Lytham Partners. We are the financial relations consulting firm for Trinity Biotech. With us on the call representing the Company today are Mr. Ronan O’Caoimh, Chief Executive Officer; Mr. Rory Nealon, Chief Operating Officer; Mr. Kevin Tansley, Chief Financial Officer; and Mr. Jim Walsh, Chief Scientific Officer, Business Development Director. At the conclusion of today’s prepared remarks, we will open the call for a question-and-answer session. If anyone participating on today’s call does not have a full text copy of the release, you can retrieve it off the Company’s website at trinitybiotech.com or numerous financial websites on the Internet. Before we begin with prepared remarks, we submit for the record the following statements. 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. The forward-looking statements contained herein are subject to certain risks, uncertainties and important factors that could cause actual results to differ materially from those reflected in the forward-looking statements. Investors are cautioned that such forward-looking statements involve risks and uncertainty, 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. Participants on this call are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. With that said, let me turn the call over to Kevin Tansley, Chief Financial Officer of Trinity Biotech. Kevin?

Kevin Tansley

Analyst

Thanks, Joe. Today I will take you through the results for quarter four and the full-year 2012. I will begin with the results for the quarter starting with our revenue performance. Total revenues for the quarter were just over $20.8 million. This compares to $20 million in quarter four of 2011, representing a growth rate of 4%. As Ronan will provide to you with more details of revenues later in the call, I will now move on to gross margins. This quarter’s gross margin was 50.6%, which is slightly down on the 51.5% we reported in quarter four last year. The lower gross margin is attributable to higher instrument placements, predominantly sales of our new Premier instruments which increased to 65 units this quarter. I had mentioned previously that our gross margin will be impacted due to placement such as these and instrument sales typically have lower gross margins. Moving on to indirect expenses. Our R&D expenses of $800,000 this quarter were slightly lower than the levels recorded in the equivalent quarter last year. Meanwhile, our SG&A expenses also decreased from $5.3 million to $5.2 million. In both of these cases, expenditure levels have been impacted by exchange rate movements. That is to say that euro weakness has resulted in euro denominated costs being lower in dollar terms. This is offsetting the negative effects of these exchange rate movements have been adding on our revenues. Our operating profits for the quarter increased from $4.1 million to $4.4 million. This brought the operating margin for the quarter up to 21.1% and this is the first time the Company has achieved an operating margin of over 21%. We are particularly pleased with this as it’s been achieved in the context of lower gross margins. Moving on to our net financial income, this…

Jim Walsh

Analyst

Thank you, Kevin. So if you have a few moments, I’d like to take a few minutes to take you – give you an update on the progress of our cardiac market development program in Uppsala, in Sweden. But just to remind you, almost exactly one year-ago Trinity acquired a Swedish company Fiomi Diagnostics for a consideration of $13 million. You’ll remember, Fiomi has developed a high sensitivity, extremely precise quantitative immunoassay platform on which Trinity is now developing a range of high sensitivity cardiac products, namely high sensitivity Troponin I, for the detection of acute myocardial infarction and BNP for the detection of heart failure. Again, by way of remainder, the worldwide markets for these two point of care cardiac products is approximately $1 billion and growing at 14% per annum. The market is segmented as 45% USA, 27% Europe, 13% Japan, with the rest of the world making of the remaining 15%. Currently there are only three dominant players in the market, namely a leader with a Biosite Triage platform, Roche with the COBAS cardiac reader platform and Abbott with the i-STAT platform. I’m delighted to report that progress on all fronts of our cardiac product development program are progressing very well. Indeed at this time, we’re on course to have our high sensitivity Troponin product CE marked and available for sale in Europe in the fourth quarter of this year. This was quickly followed by CE marking over BNP heart failure product in Q1, 2014. Those are complete portfolio cardiac assays will be available for sale in the $270 million European market in early 2014. To obtain CE marking of course requires significant clinical trials data to be generated. To this end, we have recruited five European sites to conduct our chest pain studies. These studies were…

Operator

Operator

Certainly. (Operator Instructions) The first question will come from Jeffrey Warshauer of Sidoti & Company. Please go ahead. Jeffrey Warshauer – Sidoti & Company: Hi, good morning everyone. Thanks for taking my questions. Just real quickly, if you could provide maybe a little color on utilization of Premier instruments that were installed in previous quarters? Ronan O’Caoimh: Jeff, yeah hi, I’ll take that; it's Ronan. I mean, typically I think from moment of our recording of sale to installation, on average I think it would be probably two months. I think it might be slightly longer in the case of Menarini, but they’re distributing at cost of many European countries. And in the case of the United States where we’re selling direct, it's instantaneous and the countries I’d say -- so an average of six weeks. Thank you. Jeffrey Warshauer – Sidoti & Company: So, the number of tests that you have been seeing coming from these instruments are about on par with your expectations? Ronan O’Caoimh: Probably slightly above, I think certainly in the case of Menarini the volumes per year per instrument are running quite significantly ahead of what we had expected. I think this probably reflects basically we just increased adoption of HPLC as a method of testing. Jeffrey Warshauer – Sidoti & Company: Okay. That’s great, thanks. So, regarding your upward revision to what you think you can place in terms of Premier instruments over the next two years, is a large portion of that relative to your increased confidence in Brazil and China, or is it elsewhere? Ronan O’Caoimh: As I said, we expect Chinese approval in the next few weeks. We’re actually already booked to launch the product and towards the end of April in China, so I believe we’re launching in both Beijing and Shanghai. We’re making a donation of an instrument in each territory to the local reference laboratories. So that’s the degree of confidence we have more or bit it's not certainty relating to the approval in China. And in terms of what we would achieve and we’re confident of the run rate of 100 instruments annually as soon as we get approval, because there is a pent-up demand there, we have not been supplying our old instrument into the market over the past sort of nine months. And then in Brazil again it's almost a lengthy and difficult approval process that it includes assembly. Effectively it requires assembly of instruments in Brazil, and we’ve arranged for all of that. And in Brazil we’re confident that it's a market that hasn’t adopted in any way the big instruments, it's a HPLC market and we’re confident of achieving 50 annually. Jeffrey Warshauer – Sidoti & Company: Okay. Thanks very much. Ronan O’Caoimh: Thank you.

Operator

Operator

The next question will be from Matt Dolan of Roth Capital. Please go ahead.

Matthew Dolan - Roth Capital Partners

Analyst

Hey, guys, good morning or good afternoon over there. Ronan O’Caoimh: Hi.

Matthew Dolan - Roth Capital Partners

Analyst

The first question is on guidance, I know last year you gave us a rough outlook for 2012 and you’ve talked about trying to hit a 10% growth rate, it sounds like Premier is going well; so any color you can give us on ’13? Are you going to provide some type of quantitative guidance? Ronan O’Caoimh: Matt, Ronan here. We did $82.5 million revenue this year, and the guidance we’re giving is we’re saying that we are confident of achieving 10% organic growth. So, I think that would get you to $90.75 million. And I think in our terms of earnings per share what we’re saying is again double-digit growth. We did $0.81 that would get you kind of $0.88, get you to $30.90, but remember we have to take into account and President Obama’s medical device tax which is 2.3% which somewhat costs us a $1 million of the net of tax, $800,000 which is $0.04. So therefore what we’re guiding is north of $90.75 million which is double-digit revenue growth and north $0.86 and so more which is double-digit EPS growth, if we exclude the Obama tax.

Matthew Dolan - Roth Capital Partners

Analyst

So if you exclude it, right. So you said $0.86 adjusting for the medical device tax or the Obama Tax and that’s a basic earnings per share number or earnings per ADI? Ronan O’Caoimh: I should put in a very simple way, what I’m saying is, is that we are confident of achieving double-digit both revenue and EPS growth.

Matthew Dolan - Roth Capital Partners

Analyst

Okay, fair enough. And then on the Fiomi topic, can you explain a little more the scope of the studies that are needed to get approval in the U.S. I think you went through the European strategy and then maybe move the ball a little bit further down the line in that topic and tell us what you think you need from a commercial perspective. Will the regulatory studies be enough to see some swift adoption upon launch or will there be some commercial oriented studies that you think you’ll need to undergo?

Jim Walsh

Analyst

Matt, hi; Jim here. Essentially the clinical studies for FDA was almost two halves. The first section of clinical study that needs to be done is to determine what your -- is to determine the Troponin level in a normal population on your particular products. And that will consist of recruiting approximately 1000, between about 850 and 1000 novels which will have to be run on our product and that’s -- it's easier said and done and most of our negotiation with the FDA has been to determine what is the normal person and those normal have to be spread across all social economic groups, ethnicity, age, sex et cetera. So that’s the first studies about it, kind of a cohort of a 1000 people, roughly 50-50 male, female across all those broad sections. And you generally -- and what you need to determine is the Troponin level that is prevalent in those normal people, i.e. normal people who are not having heart attacks, okay? But that said if you like to quote off level for one without a word. Then when you have that determined you need to do chest pain studies, and these will be normal walking people into regular ERs with chest pain. And essentially the guidance there is that, particularly for Troponin the normal routine of comparing yourself to a predicate device for a standard 510(k) would be the norm. And in this case the constant predicate devices in the FDAs opinion, I mean, the most cardiologists’ opinions are not sufficiently sensitive, and their CVs are too broad. Essentially what you have to do is you compare yourself to the clinical outcome of the patients that you test versus the opinion of three independent cardiologists; so it is a very difficult trial to perform. And that’s really as we have engaged with, I think the number one cardiologist in the United States. I won't mention his name right now because we’re signing hopefully final contracts next week. He will guide us -- he was instrumental in developing the FDA guidelines. He will -- he’s going to help us select three trial sites across the United States, and we’d hope that fully will take about six months now, that’s roughly what we’re estimating.

Matthew Dolan - Roth Capital Partners

Analyst

Okay, so that sounds pretty extensive. That data I presume would be sufficient to see a swift launch; is that fair?

Jim Walsh

Analyst

Absolutely. But apart from that, I think the fact that we will need to engage with one or two more of the key opinion leaders. But the data is wonderful and it certainly will be compelling, but of course what you actually -- you really need is some of the key cardiologist seeing the praises of the product and sort of recommending its use. And of course we will be doing that over the course of the next six months as well so that we will have some white papers et cetera, et cetera from the key opinion leaders to support the very lofty claims that the FDA are making is commit to.

Matthew Dolan - Roth Capital Partners

Analyst

Sure, okay. And the last one for, Kevin. Just a few clarifying points on the quarter. What was the Premier contribution of revenue, and then can you walk through some of the constant currency metrics for the quarter that you typically provide in terms of growth?

Kevin Tansley

Analyst

Yeah. Constant currency for the year as a whole as we said the impact was approximately 1.5% which was about $1.2 million Premier for the -- the total Premier for the quarter was approximately $1.5 million, that would include sales of the instruments themselves and reagents bring us about $4 million for the year as a whole.

Matthew Dolan - Roth Capital Partners

Analyst

Okay. And then just last one, I’m sorry. The economics of Premier in China and Brazil, are they the same as what we were estimating in Europe and the U.S? Thanks again. Ronan O’Caoimh: Ronan, here. The economics of Premier in China and Brazil would be -- the profit margins wouldn’t be as high as in the United States, but they’d be similar to what we achieve in Europe.

Matthew Dolan - Roth Capital Partners

Analyst

Thank you. Ronan O’Caoimh: Thank you.

Operator

Operator

Our next question will be from Larry Solo of CJS Securities. Please go ahead.

Lawrence Solo - CJS Securities

Analyst

Hi, good afternoon. Just a few follow-ups for you guys. On the Premier just in terms of country-by-country and not looking for any exact numbers, but you mentioned China you could do 100 per year. This year, obviously starting a little bit later in the year. Do you think with pent-up demand are you targeting close to a 100 in placements this year alone, or is that a more annualized number beginning in ’14? Ronan O’Caoimh: Hi, Larry, Ronan here. I just might say to everybody, just to mention who you're. This is Larry Solo, who is the Healthcare Research Analyst with CJS security probably from New York and CJS initiators coverage on Trinity, I think your report came out in December of ’12, so just two months ago. So, it's a very comprehensive 20 page report and with my recommendation and a price target of $21, just to say that we (indiscernible).

Lawrence Solo - CJS Securities

Analyst

I appreciate that plug. Thanks. Ronan O’Caoimh: I see somebody else who’s going to ask a question in a moment and I’m going to mention him as well, but anyway just to answer your question Larry, to say that in China, yeah what I’m really saying is, I think we could do a run rate of 25 units a quarter. So it just depends when we get the approval. I mentioned that we basically bought our tickets to Shanghai and so we expect -- we really expect to get about 2.5 quarters out of this year of which would be 67.5 units. And so, of that magnitude, but we’re certainly confident of our run rate of 100. Just to remind you that China has a very significant diabetes problem. It's got 90 million diabetics, and the Chinese regulatory authorities are very conscious of it. They are very big supporters of HPLC as opposed to kind of the looser CVs associated with the big immunoassay instruments, and we believe that this is going to be a very big growth market.

Lawrence Solo - CJS Securities

Analyst

Got you. And that for Brazil, I guess, you’re expecting sort of a Q3 approval, was that what you said? Ronan O’Caoimh: Yeah, Larry Q3. Yeah, we’re confident of that.

Lawrence Solo - CJS Securities

Analyst

That’s over 50 placements per year, and can that run rate -- can you -- is that sort of a like a $10 million, $15 million per quarter type run rate or is that a little more …? Ronan O’Caoimh: No, I think again it would be a placement potential of about $12 or $13 per quarter which adds up to 50 a year and you’d get four or five years of that after which you’ve taken the very big market share.

Lawrence Solo - CJS Securities

Analyst

And just Menarini, I know the ion-exchanges is expected to come out sort of mid year, just to clarify did you say actually you expect it to double on a sequential basis by Q4? Ronan O’Caoimh: I think no …

Lawrence Solo - CJS Securities

Analyst

For the opportunity? Ronan O’Caoimh: Well, I think that – we’re just about double. Because bare in mind Menarini was strongest in Italy; they’re an Italian company, they’re strongest in Italy and in Spain, Portugal and Greece. And really at the moment because of the presence of this variant A2 our boronate affinity is only suitable for up to maybe 50-50, somewhere between 50% and 60% of the hospital placements. So we’re planning, we’re just far in affect from taking on the entire market. That we’re confident of having completing our ion-exchange through development program -- instrument development program by the end of June. We’re really confident of that. But just based on what happened last time with the boronate affinity instrument I think by the time that they finished their packaging and their whatever else and their own checks and studies and check amounts, I think it's going to be realistically start of quarter four before we start any serious placement of that new instrument in those markets.

Lawrence Solo - CJS Securities

Analyst

Okay. And just to confirm, you said for 2014 you expect to -- you’re target is now closing in on 500 placements, was that correct? Ronan O’Caoimh: That’s right, yes.

Lawrence Solo - CJS Securities

Analyst

Okay. So that is sort of an up -- I think last -- I think you guys have been targeting more in the mid-400s, so I guess, that that’s a little bit of a higher number, that you’ve spoken publicly, right? Ronan O’Caoimh: I mean, as an example I mentioned that for example -- there’s only so many resources we have to launch this product right throughout the world in terms of -- because remember there’s regulatory factors in each individual country. So for example in Turkey, we basically placed 28 instruments last year. So that just will give you an impression of the kind of potential that you have, and when you start talking Russian, India, Indonesia, Philippines, Malaysia, Korea. Yeah, so there’s monstrous potential there.

Lawrence Solo - CJS Securities

Analyst

Just a couple real quickly, your outlook for gross margin, I guess I assume that the device tax will be going into in your cost of goods sold, is that right? Ronan O’Caoimh: Current working assumption is that it will end-up there. We are waiting, so the consensus opinion from the accounting firms and presenters in relation to this and obviously we will track, that’s assuming there is consensus on it. I have heard various other locations where it could appear on the P&L including the other operating expense line and also maybe SG&A. That’s the moment, and my working assumption is it will be in the cost …

Lawrence Solo - CJS Securities

Analyst

It seems like it's about a 100 bps pretax, am not aware it is, on the base relative to revenue, $1 million pretax maybe slightly more than 100 bps on the revenue as a percent of revenue. Just the gross profit outside of the -- independent of where that tax goes, do you expect it, -- I know with the new placements and all you had a slight impact in Q4. But as you look out for’13 and where do you see gross margin, excluding the tax? Ronan O’Caoimh: If you exclude the tax, I mean I see us still being sort of in around sort of the -- somewhere between 50% and 51% and I mean we’re still seeing very high volumes of Premiers going out and at an increasing rate. So, once you’ve got that sort of percentage of placements versus an installed base going out, you’re going to have a slight ride on the gross margin. So, I mean still very strong gross margin from our point of view, but just lower than we would have been in the past without or happy to have the impact on us because essentially it is a very good new story.

Lawrence Solo - CJS Securities

Analyst

Okay. Then just last question; did you give the capital expenditure number for the year, what total capital expenses were, I guess the large portion of that is obviously the capitalized research and what it was to ’12, and what your expectations are for ’13? Thanks Ronan O’Caoimh: The total expenditure for PP&E for the year as a whole would have been approximately $2.7 million and for that, as I did mention the intangible number which is around $15 million -- just like the above $15 million. I see us in 2013 doing similar levels; a lot of it will be impacted by the timing of the trials in relation to Fiomi which is the largest single item that we’re going to have particularly the FDA trial. So the question is to what extent, day four or pre opposed year end, so similar number in relation to that.

Lawrence Solo - CJS Securities

Analyst

Got it. Great, thanks so much.

Operator

Operator

Our next question will be from Bill Bonello of Craig-Hallum. Please go ahead.

Bill Bonello - Craig-Hallum Capital Group

Analyst

Hi, thanks for taking my question. A few things here. First of all, just I want to clarify what you said about expectations for 2013 just to make sure I’m crystal clear. I think what you were saying is, you believe you can grow 10% plus EPS excluding the impact of the medical device tax, so that the actual reported growth might be less than 10%. Am I correct about that? Ronan O’Caoimh: That’s correct, Bill, yes.

Bill Bonello - Craig-Hallum Capital Group

Analyst

Okay. And then the FX again, you answered what it was for the year, but what was the impact on the quarter?

Kevin Tansley

Analyst

The impact on the quarter would have been about a couple of $100,000 for the quarter – for quarter four.

Bill Bonello - Craig-Hallum Capital Group

Analyst

Okay.

Kevin Tansley

Analyst

I will say by the way that, that impacts revenue and caused revenue to fall by a couple of $100,000. That is made up, if you go down towards -- down throughout the P&L and causes direct expenditure and to the extent our cost of sales to be lower. So it is essentially a wash to the P&L. Ronan O’Caoimh: Bill, I might just -- I mentioned that, just to introduce Bill Bonello of Craig-Hallum in Minneapolis. And just to say that I know that you just initiated coverage of us literally about two hours ago. I have the reports in my hand 14 pages very extensive report. We’re delighted that you’ve done this. I see that you have a buy target of $24 on those and just to mention, we put up in the website yet? It's just got up on the website and I am sure it's available. Anyway so Craig-Hallum just initiated by recommendation on Trinity Biotech so, I appreciate that clarity in all the work that you’ve been doing over the past couple of weeks in preparing the report.

Bill Bonello - Craig-Hallum Capital Group

Analyst

Well, thanks. That’s very nice of you. Jim, I wanted to ask just a question, can you give us a little more color on how on the Fiomi side and how the test is comparing on the bench, compared to both maybe the point-of-care devices that are out there and maybe the lab-based instruments that are out there, I mean some sense of where you’re catching patients with elevated Troponin’s compared to those devices?

Jim Walsh

Analyst

Sure. No, problem. Bill, simply the market leaders as you know, the market is essentially, the point-of-care market is made up of i-STAT Roche and the Triage product from Alere. And to the couple of sort of real numbers that we compare ourselves against each other with, okay. And the first one is; the limit of detection of each of our platforms. The limit of detection is essentially the smallest amount that of this particular product that each of our platforms can actually see in a human blood sample okay. And consequently the lower year limit of detection the more sensitive your assay is and potentially the more people in the early stages of a cardiac issue can be detected. So just to give you a flavor, the Fiomi limit of detection is 8 picograms per mill, that’s a very, very tiny amount, okay. If I compare that to for instance Triage, they would have a limit of detection of 50 picograms, i-STAT of 20 picograms and Roche of 50 picograms. So compared to Triage we’re better than 10 times better or close to 10 times better. By the way those numbers are not numbers I made up, they’re actually from those manufacturers, package inserts. But a more important number apart from the limit of detection is limit of quantification. That’s the measure of how sensitive your test is, but also how precise your test is. That is, if you’re drawing the same sample from the same patient, 10 times theoretically you should get the same answer every time, but of course all test, you just don’t all test have varying CVs. So on our test, our limit of quantification which is set by the FDA as meeting a limit of quantification at a 10% CV. So you’re only allowed…

Bill Bonello - Craig-Hallum Capital Group

Analyst

Okay. And just because, I know that those limits of quantification that you’re talking about that the actual numbers can be impacted sort of by the way the instruments are calibrated. If you were looking head-to-head I think maybe you’ve done this, but if you could tell you were looking head-to-head at the same specimen, say using your instrument and using Abbott instrument. Are you finding that you’re able to quantify specimen Troponin in samples where Abbott you just don’t get a result? Ronan O’Caoimh: This is Ronan coming in here for a moment. The issue is that, if you have say 10 people going into hospital at 7 O’clock in the morning, all 10 men having felt that they’ve had a heart attack. What happens is that all 10 get tested with a rapid Troponin test. One guy has had a heart attack, he’s rushed off and stents put in and whatever else and the other nine hang about the hospital all-day long and they get another three Troponin test, right? Now, what's happening basically is that we are picking-up basically people who’ve had a heart attack and the other three aren’t, that’s why the FDA are so freaked out about this whole thing. People who’re getting sent home who had a heart attack under the impression that they haven’t had an heart attack, and then with subsequent possibly disastrous consequences. So that’s why this basically human beings are being sent home under the impression that hey haven’t had a heart attack, when they have because the existing rapid tests basically aren’t detecting Troponin at a low and off level.

Bill Bonello - Craig-Hallum Capital Group

Analyst

Excellent. Okay, that’s what I was trying to figure out. And then are there any milestones along the way where we’ll kind of know how things are going or we can sort of not have information until we get to the end of the clinical trial process? Ronan O’Caoimh: Well, I think there’s going to be -- actually there’s going to be one very, very big milestone that you’re going to see. And I think you’re going to see it very quickly, and that is, I believe that we are going to get -- we believe that we’re going to -- we’re confident that we’re going to get CE marked to enable us to freely sell this product to Europe before year end, and I think -- and that we’ll be thrilled to see.

Bill Bonello - Craig-Hallum Capital Group

Analyst

And when that happens, would we expect that there could maybe be clinical publications that go along with that? Ronan O’Caoimh: Absolutely, well these will be independently run trials, I mean remember those trials are about to start within seven weeks of today exactly, but we have five trials I’ve selected and each of them will be run by an opinion leader in the whole cardiology area. The fact of the matter is, as soon as this trial is over and the product is seen outdoor, team leaders will adopt the product because at the moment they don’t have a product good enough for the needs, and they will happily publish.

Bill Bonello - Craig-Hallum Capital Group

Analyst

Excellent. And then the last question, just any or what is your latest thinking in terms of pursuing a diagnosis indication on the A1c side of things?

Rory Nealon

Analyst

Hi, this is Rory here. It's something believe or not I filed out on the submission today to the FDA to pre-submission so that should be going into there tomorrow to the FDA. It's a little bit of an unknown just for those of you who aren’t aware of it, there was a meeting in Washington, I think it was last October at which the various industry members attended mainly the HPLC members and also the Immunoassay suppliers of the industry, all of course were looking for a diagnosis claim. And for those who aren’t aware of it, there is no instrument on the market today that has a claim for diagnosis from the FDA. Everybody has a claim from monitoring A1c levels. The practicalities and the reality is that doctors are submitting, getting results and using it for diagnosis, but nobody actually has a claim. So if everybody sees obtaining a claim of something that would significantly help them for the marketing perspective. So, where we're, the FDA have basically said that to get a diagnosis claim you have to have CVs south of 2%, we are close to 1%. We are putting in our submission, but it isn’t unknown in terms of how the FDA will react and what it is that they like – actually want us to before we start actual trials.

Bill Bonello - Craig-Hallum

Analyst

Great, excellent. Well, thank you very much.

Rory Nealon

Analyst

Thanks, Bill.

Operator

Operator

Our next question will come from Ross Taylor of Somerset Capital. Please go ahead. Ross Taylor – Somerset Capital Management: Yes, gentlemen, I want to get into the economics of the Troponin product. There’s a lot of talk about how valuable this would be to the company. Have you guys given thought to what kind of operating margins one would be looking at, what cost of sales would we be looking at, kind of what the bottom-line impact would be and then additionally I noticed Ronan in your recent hand out at presentations you’ve added a line saying you state that you expect to obtain a significant share of the market. Now that’s $1 billion market, and I’d like to know what your definition of significant is, is it 10%, 20%, 30%? Ronan O’Caoimh: Hi, Ross. Just the name of the issue of margin for a moment, I mean we can manufacture the product for about $2 or less, and the current market -- they’re marketed at about $15 a Troponin, maybe $25 for BNP. So you’re talking big margins there. In terms of what market share we could take and there’s a number of factors you have to bare in mind, and one is of course is that we don’t know who else are doing what, but what I will say to is that, we believe strongly that the cardiologist will very, very quickly adopt this product when it is giving such monstrously superior performance compared with the three current incompetents and there are really only three. I mean Jim, has quoted basically numbers which just made simple means, but people are being sent home under the impression that they haven’t had a cardiac event, when they have had one, but often disastrous consequences, it's simple as that. The…

Jim Walsh

Analyst

Chlamydia or some of the TSH or some of the cancer assays where they really are fighting for sensitivity. The platform has a huge application. Ross Taylor – Somerset Capital Management: Okay. So basically what this is, is once we get this approved for Troponin and for BNP, it really opens up a vast additional market for you guys? Ronan O’Caoimh: Absolutely. I mean, remember that up to now we’ve been working in a kind of bit pregnancy test type of technology. We can just tell you yes or no. Now we got greater, much better sensitivity, much better precision, but also we’ve got a machine read, so we could actually tell – we can tell you the level, we can quantify. So it’s just entirely useful.

Jim Walsh

Analyst

And of course Ross, one huge attribute is a multiplex, from one sample now you can obtain maybe four or five results whereas in our current platform, one test one result. So that opens up, the possibility of panel assays like maybe test for – pediatric testing or whatever. Ross Taylor – Somerset Capital Management: Okay. And what it really is also seems like is these are markets – these are in aggregate these are billions of dollars of markets that right now you don’t address or you address segments of them through your lateral flow testing. And so there is some – I’d think we’re really talking about huge potential upside, kind of game changing opportunity if we are able to get this thing through the FDA. Ronan O’Caoimh: There is absolutely no doubt, that the Troponin – this Troponin approves us from the FDA will be transformational for Trinity. Ross Taylor – Somerset Capital Management: Okay. And at the same time, it looks like your core business continues to roll on very well. Right now are you loosing money in Brazil? Ronan O’Caoimh: Yes, because we’re not selling anything whatsoever. But that’s going to change very quickly. Ross Taylor – Somerset Capital Management: Okay. Great. Well, congratulations, it looks like things are really rolling out well. Thank you very much. Ronan O’Caoimh: Thanks, Ross.

Operator

Operator

The next question will come from Walter Schenker of MAZ Partners. Please go ahead. Ronan O’Caoimh: Hello.

Walter Schenker - MAZ Partners

Analyst

Broke my ear phones and I’m quite surprised Ross didn’t bring it up, but before I say anything I just like to thank Jim Walsh, my bear made it home safely.

Jim Walsh

Analyst

I’m glad to hear that Walter.

Walter Schenker - MAZ Partners

Analyst

Everything is going well. We clearly have growth sort of well with established from the Premier instrument reagents, it’s a longwinded question, but and then we have Fiomi which looks outstanding. The only thing I want to complaining about Ronan and I’m complaining about it seriously and loudly is the buyback is moving very slowly. It almost looks like you stopped as the stock price appreciated. The number of shares are not declining; I realize we issued some to Fiomi. It seems to me that buying 100,000 shares a quarter is not getting us much in the way of movement and we have nothing better to do with our cash than buy our stocks. If you listen to this call on replay, Ronan, I'm sure you will be all excited about the prospects of the Company, why aren't we buying more stock? Ronan O’Caoimh: I think we pay dividend, we’ve been doing a certain amount of buyback, but given I think the recent move in the price we have just stood back from the market. And it no way means that we don’t think the price is going – we think price won’t go any further. Of course we do, I mean, just today Craig-Hallum coming out with a $24 target. CJS came out last month to a $21. But at the same time, we’re there to buy more aggressively in the event of any weakness. I mean just in general terms we discussed this again in the past and I’ve discussed it with [Ross] and many shareholders have different opinions, but we have the view that, for Trinity Biotech to maintain a recently strong balance sheet is probably a sensible thing for it to do. Walter so – and furthermore just to say that this is a matter that is discussed by the Board and determined by the Board and activated by me and the management team. So it’s not entirely our decision. Indeed, it’s not our decision and …

Walter Schenker - MAZ Partners

Analyst

Although we all agree on the call, because its straight math that on $0.80 of earnings the return on buying back stock is 5%, which is the earnings return and I realize you get somewhat however you returns on cash, in Ireland, and those are after tax returns. So it still is non-dilutive to buyback stock at current prices. And, I guess, I will pursue this offline, but I wanted to make the case online. Thank you, Ronan. Ronan O’Caoimh: Okay. Thanks very much. I think – I just see Paul Nouri has been waiting for long time to ask question. Could we just maybe make that the last question? We’re actually setting a record we’ve been an hour and five minutes on the line, maybe we close it at that point.

Operator

Operator

Certainly, our final question then will be from Paul Nouri of Noble Equity Fund. Please go ahead sir.

Paul Nouri - Noble Equity Fund

Analyst

You talked about it a little bit, the increase and goodwill. Can you nail down a little bit how much of the increase is associated with cost going into research and development related to Fiomi and what that number is going to look like next year?

Kevin Tansley

Analyst

Yeah, I think you’re talking there about the movement in our intangibles we had?

Paul Nouri - Noble Equity Fund

Analyst

Right.

Kevin Tansley

Analyst

Increase in goodwill and another intangibles on the date of acquisition of approximately $14 million. We had then approximately $15 million of other movements occurring during the year of which Fiomi was approximately between $6 million and $7 million. Next year I see the number be somewhat similar. It will vary from what depending to what exact stage we’re at in relation to the clinical trials. The biggest single element of next year will be the FDA trials, which will be upwards of $3 million and just exactly where we’re on that cycle will determine how much will be next year. So it will be of similar order next year.

Paul Nouri - Noble Equity Fund

Analyst

Around the six, $7 million number?

Kevin Tansley

Analyst

Yeah.

Paul Nouri - Noble Equity Fund

Analyst

Okay. Thanks. Ronan O’Caoimh: Well, thank you very much. I think at this stage, we’re out of questions and so maybe we will close the call. I just wanted to thank everybody for your interest and your support and we look forward to speaking to you I think in about 6 week time – 6.5 weeks time when we have our quarter one conference call. So till then thank you very much and good afternoon.

Operator

Operator

Thank you, sir. Ladies and gentlemen the conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.