Hello and welcome to the Trinity Biotech Third Quarter 2013 Financial Results Conference Call. All parties 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 of Lytham Partners. Please go ahead.

Thank you, Aimee, and I thank all of you for joining us today to review the financial results of Trinity Biotech for the third quarter of 2013, which ended on September 30, 2013. As Aimee indicated, my name is Joe Diaz. I am with Lytham Partners. We are the financial relations consulting firm for Trinity Biotech. With us on the call today representing the company are Mr. Ronan O’Caoimh, Chief Executive Officer; Rory Nealon, Chief Operating Officer; Kevin Tansley, Chief Financial Officer; and Jim Walsh, Chief Scientific Officer and 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 copy of today’s release, you can retrieve it off the company’s website at trinitybiotech.com or numerous financial sites on the Internet. Before we begin with 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 those forward-looking statements. These 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 uncertainties, but are 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 identified and 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 of the date hereof. The company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which maybe made to reflect events or circumstances after the date hereof. With that said, let me turn the call over to Kevin Tansley, Chief Financial Officer for reviewing the financial results. After that, we will hear from Jim Walsh regarding the developments at Fiomi, and finally Ronan will provide his overview of the quarter. Kevin?

Thank you very much, Joe. Today, I will take you through our results for quarter three 2013, including the income statements for the quarter, our review of the major balance sheet movements between June 30 and September 30, and the cash flows for the quarter. Beginning with our revenues. Total revenues for the quarter were just over $24.1 million, which compared to $20.9 million in quarter three 2012, and thus represents a growth rate of 15.7%. This includes approximately $1.8 million of acquisition revenue and excluding this revenue growth for the quarter would have been 7%. Later in the call, Ronan will provide more details on this quarter’s revenues. I will now move on to gross margin. As you can see from our press release, this quarter’s gross margin was 50.3%, which is a little lower than the 51% that we reported in quarter three of last year. This reduction was expected and is the result of the impact of the significantly higher level of placements of Premier instruments, which at 81 this quarter is the highest in a single quarter to-date. I’d also like to point out this quarter’s margin represents an improvement on the 49.8% achieved in quarter two this year. Moving on to our indirect costs, our R&D expenses were $876,000, which represents a slight increase from the $767,000 announced in quarter three 2012. Meanwhile, our SG&A expenses have increased in the quarter from $5.1 million to $5.9 million. Both of these increases were due to the impact of the Immco acquisition and represents the first two months’ expenditure post acquisition. Our operating profit for the quarter was $4.9 million, up almost $600,000 compared to the same quarter last year representing an increase of 14%. Our operating margin of 20.5% this quarter was similar to the 20.9%…

Thank you, Kevin. I’ll take a few moments now to update you on our cardiac market development program at Fiomi in Uppsala, and I’ll also be happy to take any specific questions you may have in our question-and-answer session at the end of the call. By way of background, you will note that Trinity acquired the Uppsala-based Fiomi Diagnostics a little over a year and a half ago for a consideration of $13.1 million. Fiomi had developed a high sensitivity, precise, quantitative immunoassay platform. Trinity is now developing a range of high sensitivity point-of-care cardiac marker products on this platform, and in the first wave, we are developing a high sensitivity Troponin I product for the detection of acute myocardial infarction and a BNP product for detection of heart failure. The competitors in this space are Alere, Roche, and Abbott. The aim of Trinity’s development program is to develop a point-of-care Troponin product capable of meeting the new FDA guidelines, a level of performance that has to-date not been achieved on any point-of-care diagnostic platform. In short, I am happy to report that our Troponin product is meeting this high performance threshold and that we are making excellent progress in reaching our goal to have our Troponin product CE marked before the end of 2013 and consequently available for sale in Europe beginning 2014. Moreover, we expect to commence clinical trials for U.S. approval as planned before the end of this year. I’ll now provide you with a more detailed update on our CE marking project. CE, as you know, is the regulatory standard required to market a product on the European and other selective markets. In general, there are three aspects to the clinical trials necessary to obtain CE certification; namely a normal population study to determine the upper…

(Operator Instructions) Our first question comes from Larry Solow at CJS Securities. Larry S. Solow – CJS Securities, Inc.: Great, thank you very much. Ronan, just on the – just to confirm on the HIV-expanded label or the new approval, is the – I realize it’s certainly a big thing to at least steady the market, stop your declines, and it sounds like you’re going to get always some initial growth from it. Is this something that you can meet a sustainable growth in the U.S., as you look out beyond 2014 over the next several years? Ronan O’Caoimh: Absolutely, yes, I think the reality is that we’ve been very seriously constrained by the lack of HIV-2 license over the past number of years. It’s something we’ve not talked about very much, but we’ve been very, very busy now for over two years in trying to get the HIV-2 approval, so this is a major positive for us. I think the other factor just from a purely defensive perspective we have to be realistic is that the FDA were –CDC were beginning to recommend HIV-2 testing, although they actually are the tiny incidence of HIV-2. and in reality, it’s a huge cross, the activity between 1 and 2. But in any event, they were beginning to do that, and of course, the danger of the guideline from the CDC lurked. And of course, that would have been catastrophic for our business. But when you combine that then with the reimbursement factor, which is fairly comparing the $11 versus $19, it really meant that it was very, very difficult for us to grow us business, in deed to retain our business in the hospital market, and meanwhile then more and more individual states were actually – were looking for HIV-2 claim.…

As we mentioned, we’re going to do 320 this year. We’re comfortable that we’ll do that. We’ve done most of it already. In terms of next year, I wouldn’t hang my hat on 500, but I’d be disappointed, but if I did not get very close to us. I think that the positives are that we’ll have a full year in China where it’s certainly only got approved sort of in June in China, and we will have the Ion Exchange operating for Menarini in Europe, which means they’ll be setting in Spain and Italy, which are their primary markets. We will be setting in Brazil, and we’re very confident of what we can do in Brazil, and meanwhile, then we are rolling out the product range across Indonesia and the Philippines of this world, gradually doing that. All of that I think should culminate in something we haven’t – we’re not indicating a number at this moment, but it would be in and around the 500 mark, it would be very close to it or in deed, it could exceed it, but just a little bit coy about indicating exactly what we do there. And then just in terms of usage, just to mention the one thing is the actual amount of reagent that each individual instrument is running is probably is slightly in excess of what we had expected, but what I would caution one thing is that there is probably a slightly bigger gap. There is actually a longer gap between the moment that we ship the instruments out of Kansas City and that it ends up actually operating in China running 20,000 tests per annum. And certainly that on average is probably about seven months across the entire world just because it goes through distributors and…

The next question comes from Bill Bonello, Craig-Hallum. Bill B. Bonello – Craig-Hallum Capital Group LLC: Good morning or afternoon or whatever it is for everybody. Few follow-ups on the Troponin, you mentioned that the 99 percentile appears to be about 42 picograms. Can you detect at that level with a 10% CV, and how low can you detect with a 10% CV?

Bill, so I’ll take that. The answer is yes, 42 picograms is our 99 percentile. We have – we haven’t totally completed the analytical studies, but yes, we do seem to be able to detect as or below that number with a 10% CV, okay. So as we stand at the moment, our limit of detection, your first question, how far – how low can we go per se, is about 6 or 7 picograms, okay? So we can see as low as 6 or 7 picograms. We are able to measure, it would seem in the normal population, we are – we do seem to be able to measure greater than 50% of all patients. I actually give them a reading, if you like okay, between about 5 picograms and the 42 picogram 99 percentile, so that’s quite encouraging. And so yeah, we’re within a picogram or 2 below the 99 percentile where we have a 10% CV, but I expect that that will even go lower, as we tidy up the dataset. Bill B. Bonello – Craig-Hallum Capital Group LLC: Okay. And will even go lower in other words, the level at which you could read with a 10% CV is what you are…

I am not suggesting we’re going to go very much lower, but we’ll certainly be lower than the 42 picograms. Bill B. Bonello – Craig-Hallum Capital Group LLC: Okay. And then the significance of the… Ronan O’Caoimh: I… Bill B. Bonello – Craig-Hallum Capital Group LLC: Go ahead. Ronan O’Caoimh: Ronan here, the other thing is that, of course, is that the 42 picograms is the Swedish reading. It’s likely that the U.S. 99 percentile will be somewhat higher giving us a greater – and a greater scope and freedom to operate, basically giving us a greater safety in that, is likely that the U.S. population will be higher than 42. Bill B. Bonello – Craig-Hallum Capital Group LLC: Okay. I’m not sure… Ronan O’Caoimh: The Swedish tend to be very, very [indiscernible]. Bill B. Bonello – Craig-Hallum Capital Group LLC: Got it, okay. I get that. And then the significance of the being able to read and greater than 50% performance is that hits the second criteria for being labeled a high sensitivity Troponin test, is that right?

No other test has been even close to achieving that Bill, okay. And I’m not just saying yet that we have actually achieved it, to really go through the data with a fine-tooth comb, but it looks like certainly from the 500 normals that we have read in Sweden that we are detecting slightly over the 50%, okay, so that – if that holds through, it will turn us into the – a true high sensitivity assay. Bill B. Bonello – Craig-Hallum Capital Group LLC: Right. Okay. And then just when we think about sort of the data itself, what kind of data will you actually make public and what was sort of the format of that data being made public. So as you’re around the CE marking, how will we actually know the performance?

It will be absolutely clearly put out in our – in instructions for use package insert, Bill, that will go with the kit. So the data that you’ll actually see you will see from the analytical studies, you will – well, first of all, from the normal studies, you will see the actual final 99 percentile of the normal population in both whole blood and plasma, okay. You will then see within that package insert, you will see the LOQ at 10% for – as determined in plan in the analytical studies for both whole blood and plasma, so that will give you the – essentially the confidence that the product meets, if you like, the new FDA guidelines. You will then be able to see calculative sensitivity and specificity of the product, okay, which is different to the sort of analytical performance. The 99 percentile is all very fine, but how good is the product at actually ruling in or ruling out sort of MI. So it will be – there’ll actually will be sensitivity and specificity data within the pack insert that will show you versus the clinically adjudicated samples, where three cardiologists say yes or no that patient did or didn’t have a heart attack. We’ll then be comparing our results against that to see how sensitive and specific our test is. So that will be published. You’ll also see data on interfering substances, if any; the threshold at which substances interfere. You’ll see shelf life data. You’ll see – it will actually all be published, Bill, in the instructions for use that will roll with the kit as it’s put on to the market in late this year, early next year. Bill B. Bonello – Craig-Hallum Capital Group LLC: Okay, and is there anything that we’d see in advance of that? For instance, do you put anything out on the normal studies? Is there anything that you put out or is there anything that you put out in a press release along with CE marking or really everything comes sort of in a bundle with the instruction for use?

I don’t know if we have – I don’t know if we had [indiscernible] Bill. The data will – the data set will be available put it that way okay. The data set will be available certainly late November, early December okay. The CE marking process – so theoretically, we could make that data public at that stage. The CE marking process itself takes probably three or four weeks. So okay, so that – I would suggest it would be more prudent perhaps to wait to get the CE mark before you’re public – before you publish the results formally. But the difference is a matter of two or three weeks between having the data and then actually getting the CE mark itself. Bill B. Bonello – Craig-Hallum Capital Group LLC: Yes, okay, great. Thank you very much.

(Operator Instructions) Our next question comes from Chris Lewis at ROTH Capital Partners. Chris W. Lewis – ROTH Capital Partners LLC: Hey, guys. Good afternoon. Ronan O’Caoimh: Hi, Chris. Chris W. Lewis – ROTH Capital Partners LLC: And first just on the Lab 21 acquisition, I guess you talked a little bit about the backorder position and your focus on ramping that manufacturing in the fourth quarter there. So can you just give us a little history of that, I guess, how long that backorder has been there and how long do you think, it will really take to get that manufacturing ramped up and of the speed to kind of fill the orders out there? And then to follow-on to that, what gives you the confidence that no customers have been lost from that backorder situation.

Hi, Chris, it’s Rory here. The backorder has been lingering, that’s the best word for between one and two quarters, in part driven by the difficulties that the previous owners had. From a financial perspective, it led to lack of supplied raw materials, a few less topics, et cetera, et cetera. and we believe we’ll have a turnaround for the majority of the products by about December and so one of our top products in particular, probably into January, February kind of timeframe. It’s not like there is zero supply, in the meantime, there will be limited supply as a result of which customers will get partial orders and also remember customers typically, in fact, really much all of them tend to store a level of safety stock within their own sites to keep them going into that, and any norm, any issue whether it’s shipping or technical or whatever. So those customers are effectively running those docks down as we speak, we’re also – I’m going to start supplying them the partial orders. So we’re pretty confident, we’ll get to December through January and get through this with little or no effect on the business. Chris W. Lewis – ROTH Capital Partners LLC: Okay. And then just what gives you confidence that none of those customers have been lost since the backorder over the past couple of quarters here?

Well, the part of our due diligence obviously involved going back and looking at the customer base as it was in 2011, 2012, early 2013, and we’re able to take that and track and see where the business is today and continue to monitor that literally on a week-by-week basis. So we’re pretty confident we will get there by the end of the year. Chris W. Lewis – ROTH Capital Partners LLC: Okay, great. And then as we look out for that business in the 2014, how should we think about that just in terms of its overall growth outlook and accretion profile. I think you said it was going to be accretive in 2014. Can you kind of give us a little more detail around that along with expectations around the top line growth? Ronan O’Caoimh: Yeah, Ronan here. In terms of – just in terms of P&L wise, obviously, we’re running two factories and for a period of time until about next April, May, June. and so it’s difficult to make a profit in those circumstances. I think as soon as that happens, this thing becomes decently profitable and earnings accretive. In terms of kind of accruals we can get, we indicated that it’s doing $4 million. And we would be confident growing this 20% annually. we wouldn’t have jumped by it otherwise. In reality, as if we can make the kind of headway that we hope to make in the USA and thus we can do materially more than that. I would just caution that’s going to take a little bit of time, because to get into the FDA, it’s not just a matter of getting the FDA approval on the product, but also on the system. And so it’s going to take a bit of time…

All right. Well, in answering that question, of course, the point – quick point is sort of an acquisition become organic growth. But just in general terms, it’s like – I’ll make the point that if you look at our overall business and we’ve had a business, which I think [indiscernible] which has been a laggard and strike on us and haven’t performed well and it’s a work in process. Let’s just imagine that were to remain relatively flat, although that would not exception to us. It benefited our infectious disease business, which has probably struggled too, generally significant growth. What happened there is we’ve added Immco, we’ve added to Lab 21 and we have developed in-house a range of rapid products and the combination of all of that is going to basically give this business very significant growth. If you look at our Premier business, our diabetes business, well, we’ve got a big winner with Premier. Maybe we are about to become 25% of world market and Immco [indiscernible] over the period of next number of years are indeed more than that. So I think we all recognized that success story, you’ve got obviously cardiac coming through as a new growth business as well. And then your HIV business, which basically has inherent difficulties that are now been corrected and I think it becomes a big growth business moving forward [indiscernible].

So, I think if you examine the whole thing, I think what we have done over a period of time is we have transformed our business from one, I think, [indiscernible] growth into a business that every facet of which can grow and grow impressively with a single exception of this trial, which is a work in process. We will be back on that one. And so I’m just closing, Chris. Chris W. Lewis – ROTH Capital Partners LLC: Yeah. Okay, thank you.

Our next question comes from Ross Taylor, Somerset Capital. Ross Taylor – Somerset Capital Advisers LLC: Yes, gentlemen, congratulations on your recent moves. And I had a couple of questions just kind of trying to get my hands around a few things. One, what is the size of the European Troponin market?

Right…

You have a couple of questions, Ross? Ross Taylor – Somerset Capital Advisers LLC: Yes. What’s the size of the European Troponin market, testing market?

In the slides, it’s probably about $80 million. Ross Taylor – Somerset Capital Advisers LLC: Eight zero?

Eight zero, yes. I would – my estimate will be about eight zero. Troponin, if I had to say, – yes, probably, if I had to say $20 million for Alere, $40 million for Roche, $20 million for Abbott, about $80 million. Ross Taylor – Somerset Capital Advisers LLC: Okay. And then the BNP market as well in Europe?

I would say $20 million there and $30 million Roche and $5 million Abbott. Ross Taylor – Somerset Capital Advisers LLC: Okay. So – and at this point, neither or none of those players had a product that’s anywhere near as effective as the one you guys are developing, but is this a big an issue there as it is here. I mean, obviously here the FDA is pretty unhappy with the lack of the product meeting its standards?

Ross, this is Jim there. The answer, it is a big issue in Europe. Even though, the regulatory agencies are not per se putting the same technical sort of the classification on Troponin in Europe, the fact of the matter is clinicians themselves will use it, okay, not because of regulatory, because of good medicine. The bottom line of it is that if you have an under-sensitive Troponin test in the ER, it’s just not effective. The chances are people can die from essentially – from not being diagnosed properly. So if a product is out there, if our sales rep is out there selling a product that is actually substantially more sensitive than the competitor product, the clinicians themselves will make the move. It will have to be a key opinion leader driven. We obviously aren’t very well linked in with the key opinion leaders across the Europe, but those are the guys who we will hope to publish white papers et cetera and who will sort of evangelize their [indiscernible] result. It’s not a regulatory thing. It’s a product performance thing and I think we can be quite successful competing against the inferior products that are out there. Ross Taylor – Somerset Capital Advisers LLC: Okay. So you would expect that you would see a reasonable – reasonably quick ramp up in Europe for this product given that you aren’t facing a quality competitive threat?

And I think it’s going to take sometime, quite frankly, to get the word out there. What you really need is a number, well published papers by key opinion leaders and they can only start generating that data when the product is available for sale. So I don’t know Ronan if you would take up, but I wouldn’t have thought. I would think the lag is going to be longer maybe we might hope. Ronan O’Caoimh: I think what you need to consider here is you have to be realistic. The adoption of point-of-care product testing, component testing in USA has been much, much greater than in Europe. So in Europe it’s happened to a much lesser degree. In fact, we treated only, Ross that has succeeded to any degree and I think the other countries struggled. And I think also a very important factor is that the FDA hasn’t come out and the EU equivalent hasn’t come out and say, hey listen, all these tests are rubbish. We’re changing the guidelines and want basically a change here. So in that sense there isn’t the awareness in Europe of the deficiencies of these tests to the extent that there is in the USA. So for example, an FDA approval for a component test for that Troponin test in the USA will be a genuinely seismic event and we’re aware of it. In Europe, it’s not so seismic because there is neither a bigger market nor the same level of R&D, much awareness of the deficiencies of these particular tests. So therefore – what it need is basically it needs the opinion leadership out there and shout and talk about immediately to all of that and we will be doing all of that and we are setting up all of that.…